C1 Preclinical Evaluation of the Tiara Transapical Mitral Valve Replacement Device:
Anson Cheung1, Stefan Verheye2, Randy Lane3, Shmuel Banai4. 1St. Paul’s Hospital, Vancouver, BC Canada, 2ZNA Middelheim Hospital, Antwerp, Belgium, 3Neovasc, Inc., Richmond, BC Canada, 4Tel Aviv Medical Centre, Tel Aviv, Israel.
Objective: Preclinical evaluations of the Tiara transapical mitral valve replacement device The Tiara transapical mitral valve replacement device is a Nitinol based, self-expandable mitral bovine pericardial valve prosthesis. This bioprosthesis is designed to fit the native mitral valve anatomically. Its unique anchoring mechanisms allow secure fixation to the mitral valve structures.
Methods: Acute and chronic implantations were carried out in a sheep model. Pressurized cadaveric hearts were used in human study. In animal studies, all implants were performed off-pump via the left ventricular apex under fluoroscopic and echocardiographic guidance.
Results: Successful implants were performed in sheep models. Fluoroscopic and echocardiographic guidance allows accurate anatomical deployment. Greater than 150 acute implants were performed with good results. Seven chronic sheep implants (>150 days) evaluation demonstrated excellent prosthetic valve function and hemodynamics. No left ventricular outflow tract or coronary obstruction was observed. There was mild paravalvular regurgitation in 2/7 animals. Mean transvalvular gradient was 2 mmHg. Implantation of the Tiara valves in pressurized human cadaver hearts demonstrated proper anatomic alignment and seating of the valve in the left atrium and left ventricle.
Conclusions: Preclinical transcatheter transapical implantation of the Tiara self-expanding mitral bioprosthetic valve is technical feasible. In the acute and chronic ovine model, anatomical implantation with excellent post-implant prosthetic functions and hemodynamics were achieved. Cadaveric human implants further confirmed the feasibility of this novel device.
C2 An In Vivo Quantification of the Apical Fixation Forces of Different Mitral Valved Stent Designs in the Beating Heart:
Saskia Pokorny1, Katharina Huenges1, Telse Bähr1, Alexander Engel1, Martin Marczynski-Bühlow1,Michael M. Morlock2, JochenCremer1, Georg Lutter1. 1Department of Cardiovascular Surgery, University Hospital Schleswig-Holstein, Campus Kiel, Kiel, Germany, 2Institute of Biomechanics, TUHH Hamburg University of Technology, Hamburg, Germany.
Objective: The aim of this study was the quantification of the apical fixation force of mitral valved stents in an experimental in vivo setting.
Methods: A test set-up consisting of a force sensor aligned to the stent long axis was developed to quantify the forces acting on the apical fixation of mitral valved stents. 20 pigs (50±2kg) received a self-expanding valved stent in the mitral position via transapical approach in an off-pump procedure. The first design AP (n=10) was solely anchored apically with a fixation system comprised of four neo-chords attached to the ventricular rim of the stent. The second design SA (n=10) included additional sub-annular fixation elements within the ventricular stent body. Following stent deployment in the beating heart, correct stent position was adjusted under control of paravalvular leakages (PVL), mitral annular plane systolic excursion (MAPSE) and pulmonary capillary wedge pressure (PCWP). The neo-chords were attached to the force sensor and forces were recorded during expiratory breath hold following a standardized protocol. Forces were normalized to the mean systolic atrio-ventricular pressure difference.
Results: Force measurement was successfully conducted in 18 of 20 animals (design AP:n=10; design SA:n=8). Two animals were excluded from the evaluation due to non device related ventricular fibrillation prior to stent implantation. In group AP the mean forces and the amplitude showed a trend to higher forces compared to the group with additional sub-annular fixation elements (p=0.046; Table C2-1). The MAPSE showed good longitudinal heart function in both groups. The PCWP was within physiological range and did not change (p>0.05).
Conclusions: An intra-procedural force measurement system was developed and the fixation forces acting upon the apical fixation system of mitral valved stents were quantified for the first time. A trend towards lower forces was detected in the group with additional sub-annular fixation. Measurement of the in vivo forces provides important information of the impact of different prototype designs on the heart function as well as information for a later clinical application.
TABLE C2-1 Quantific...Image Tools
CMP1 Sutureless Aortic Valve Replacement in Octogenarians: A Time-Saving Solution
Ferdinand A. Vogt, Giuseppe Santarpino, Laszlo Gazdag, Steffen Pfeiffer, Theodor Fischlein. Klinikum Nuremberg, Nuremberg, Germany.
Objective: The era of transcatheter aortic valve implantation has given rise to an intense debate on the most appropriate treatment strategy in an elderly population. The aim of this study was to show clinical outcomes in octogenarians undergoing sutureless aortic valve replacement (AVR).
Methods: Between May, 2010, and November, 2013, 203 patients underwent AVR with a sutureless bioprosthesis. Out of these, we evaluated 83 patients (44 females = 53%) with an age ≥ 80 years with a mean age of 82.8±2.5 years. Patients received prosthesis in size S (4), M (33), L (37) or XL (9). 46 underwent isolated minimally invasive AVR, 34 had combined procedures (26 CABG, 8 others), and 3 needed a redo-procedure. Clinical follow-up data, like in-hospital mortality and echocardiography, were collected for all patients.
Results: Mean logistic EuroSCORE was 13.2±7.6%; overall mean aortic cross-clamp time was 43.2±15.9 minutes. For isolated procedures, cross-clamp time was 38.4±12.7 minutes. Mean implantation time with placement and development of the sutureless prostheses was 7.7±2.9 minutes. In-hospital mortality was 4.8% with one cardiac event; mean hospital stay was 11.8±3.1 days. We recorded the need of 7 pacemaker implantations (8.3%). During follow-up (19±11 months), we observed 2 deaths (1 patient for congestive heart failure and 1 for gastrointestinal bleeding). Echocardiographic evaluation showed a mean transprosthetic gradients of 12.1±3.3 mmHg, significant left-ventricular-mass-regression and no paravalvular leakages.
Conclusions: The study results showed a good clinical outcome in patients at the age of 80 or above undergoing a sutureless implant. Especially in isolated AVR sutureless valves in a minimal invasive approach allows short cardiopulmonary bypass time and aortic cross-clamp time. Therefore, sutureless AVR should be considered in elderly, high-risk patients.
CMP2 Short-Term Results after Minimal Access AVR Using the EDWARDS INTUITY Valve System
Markus Schlömicher, Peter Lukas Haldenwang, Baerbel Buchwald, Matthias Bechtel, Vadim Moustafine, Justus Strauch. Ruhr-University Hospital Bergmannsheil, Bochum, Germany.
Objective: The EDWARDS INTUITY valve system combines the proven long-term safety and efficacy of the Carpentier-Edwards PERIMOUNT platform with recent innovations from transcatheter valve programs. Since March, 2012, 54 implants were performed in our institution This paper presents the first short-term and 6-month clinical and hemodynamic results.
Methods: The mean age was 75.5 (±6.2) years. A EuroSCORE II of 3.5%±1.3% was found and 39% (n=21) were female. A clinical follow-up for echocardiographic assessment of the valve performance was performed after 6 months. Preoperatively, 41 patients (76%) were in NYHA class III or IV. Single AVR was performed using a partial upper sternotomy in all cases. A peak gradient of 69.5 (±23.7) mmHg and a mean gradient of 46.7 (±17.9) were measured preoperatively. A mean effective orifice area of 0.8 cm2 (±0.3) and an ejection fraction of 58.5% (±15.0) could be found.
Results: 30-day mortality rate was 1.9% (n=1). One patient died because of severe postoperative bleeding from aortotomy. In one procedure, intraoperative severe paravalvular leakage led to implantation of a conventional bovine pericardial valve. The peak and mean postoperative transprosthetic gradients were determined to be 21.9 (±7.6) mmHg and 12.1 (±4.2) mmHg, respectively. A mean effective orifice area of 1.8 cm2 (±0.3) was determined. No higher grade regurgitation (AI >+1) occurred. Late mortality rate was 5.7% (3/53). The specific causes of late deaths were reported to be urogenital infection with consecutive septicemia (n=1) and heart failure (n=2). After 6 months, the mean transprosthetic gradients were 19.0 (±6.3) mmHg and 10.0 (±2.7) mmHg, respectively. The mean EOA of 1.8 (±0.3) remained unchanged. The mean implantation time amounted 9 (±3) minutes. The mean cross-clamp time was 29±17 minutes. An average bypass time of 62 (±16) minutes was seen.
Conclusions: Short-term results show excellent hemodynamic results. A satisfying reduction of cross-clamp and bypass times could be achieved. Nevertheless, future follow-up investigation has to be awaited to gain more data concerning durability and safety issues.
C3 Comparison of Two Different Valve Systems for TA-AVI: A Propensity-Score Adjusted Analysis
Jörg Kempfert, Alexander Meyer, Won-Keun Kim, Arnaud van Linden, Mani Arsalan, Christoph Liebetrau, Helge Möllmann, Thomas Walther. Kerckhoff Clinic, Bad Nauheim, Germany.
Objective: Recently, several alternative transapical transcatheter aortic valve systems became commercially available in Europe. Data, directly comparing the performance of these different TA-AVI valves, are sparse. Therefore, we sought to analyze performance of the long established balloon-expandable SAPIEN XT (Edwards Lifesciences, Inc.) and compare to the more recently approved self-expandable ACURATE TA (Symetis S.A.) systems by means of propensity-score analysis.
Methods: In total, a consecutive sample of 182 patients treated with transapical TAVI have been included (2011-2013). The ACURATE valve was implanted in 42% (n=97), SAPIEN in 58% (n=135). In a first step, univariate analysis has been performed. To adjust for baseline variables propensity-score (PS) based inverse probability of treatment weighting has been used. In addition, potential anatomical confounders (calcification grade: CT-Agatston score, CT-effective annulus diameter) have been included within the PS estimation.
Results: Mean age was 83.4±5.3 for ACURATE and 80.0±10.0 for SAPIEN patients (p=0.001). The STS-Score demonstrated no significant difference with 7.8±4.7 (ACURATE) and 8.3±6.3 (SAPIEN). All patients were treated within a multidisciplinary heart team. Propensity-score adjustment resulted in reduction of the standardized mean difference below 0.2 indicating excellent balance allowing for valid outcome comparison between groups. All procedures were uneventful except the following severe complications leading to conversion. ACURATE: annular rupture=1; SAPIEN: device embolization n=2, apical rupture n=2, annular rupture n=1, coronary occlusion n=1. 30-day mortality rate (ACURATE: 8.0%, SAPIEN: 7.7%; adjusted OR 1.4, CI95 0.49-4.05) and 30-day stroke rate (ACURATE: 2.1%, SAPIEN: 7.4%; adjusted OR 0.24, CI95 0.05-1.20) were comparable. Necessity to perform a post-ballooning was significantly higher in the self-expandable group (ACURATE: 40.2%, SAPIEN: 12.6%; adjusted OR 4.27, CI95 2.06-8.9p<0.001). Immediate postimplantation angiography revealed comparable rates of relevant paravalvular leaks (ACURATE: 6.2%, SAPIEN: 11.1%; adjusted OR 0.56, CI95 0.20-1.57). Echocardiography demonstrated slightly higher mean gradients in the ACURATE group (12.7±5.4 mmHg versus SAPIEN 9.7 mmHg±5.6, adjusted p=0.03). A new pacemaker was required in a comparable rate of patients (ACURATE: 8.4%, SAPIEN: 4.5%; adjusted OR 2.8421, CI95 0.93-8.70).
Conclusions: Overall, both transapical TAVI devices demonstrated comparable hemodynamic performance and clinical outcome. The self-expandable valve required more frequently post-ballooning without affecting the safety profile.
C4 Evidence for Safetiness and Feasibility of Transapical Aortic Valve Implantation without Pre-Ballooning: A Propensity-Score Matched Analysis
Alexander Meyer, Jörg Kempfert, Won-Keun Kim, Mani Arsalan, Arnaud van Linden, Helge Möllmann, Johannes Blumenstein, Thomas Walther. Kerckhoff Clinic, Bad Nauheim, Germany.
Objective: A new delivery system for the SAPIEN XT prosthesis has been recently introduced. Adding a nose-cone to the device seems to facilitate direct valve implantation without pre-ballooning. Here, we report our first experience.
Methods: In total, 128 patients have been included into this analysis (2012-2013). 68.8% of procedures had been performed with pre-ballooning (“BAV group”, n=88, all SAPIEN XT). Since July, 2012, all patients have been treated without pre-ballooning (“no-BAV group”, n=40, all SAPIEN XT + Ascendra II+). To adjust for baseline variables partial exact propensity-score (PS) based pair matching has been used.
Results: The model for propensity-score calculation had a c-statistic of 0.845 and the p-value of the Hosmer and Lemeshow goodness-of-fit test was 0.14. Subsequent propensity-score nearest-neighbor matching resulted in 40 matched pairs and yielded a good bias reduction. Absolute standardized mean differences among all baseline covariates were below 0.2, indicating good balance. Especially highly unbalanced covariates before matching such as sex, history of stroke and insulin-dependent diabetes were effectively balanced in the matched pairs. Antegrade crossing of the stenotic native valve was feasible in all no-BAV patients without any events. Overall, all valves could be implanted successfully. There were no significant differences in the primary endpoints (BAV-group n=40 vs. non-BAV group n=40) leak ≥ 2+ (4 vs. 3 casesp=0.70), major stroke (0 vs. 0 casesp=1.00), TIA (3 vs. 3 casesp=1.00), requirement for re-dilatation (4 vs. 6 casesp=0.52), and necessity for new onset post-operative pacemaker implantation (1 vs. 2 casesp=0.56). As expected, fluoroscopy time was significantly lower in no-BAV patients (median 306 vs. 341 secp=0.04). Also, the outcome variables amount of contrast dye, valve-in-valve rescue implantation, and 30-day mortality showed no significant differences between groups. Especially, transvalvular mean gradients did not differ in patients without or with prior BAV (p=0.53).
Conclusions: Direct transapical implantation of the SAPIEN valve without pre-ballooning is feasible and safe. It does not compromise functional outcomes and leads to an even easier transapical procedure.
C5 Minimally Invasive CABG is Safe and Reproducible: Report on the First Thousand Cases
Joseph T. McGinn, Jr.1, Masood A. Shariff1, John P. Nabagiez1, Robert Carlucci1, Scott Sadel1, Raman Sharma1, Peter A. Abotaga1, Edward Daniele1, Laura Fazio1, Harry Lapierre2, Benjamin Sohmer2, Marc Ruel2. 1Staten Island University Hospital, Staten Island, NY USA, 2University of Ottawa Heart Institute, Ottawa, ON Canada.
Objective: Minimally invasive CABG (MICS CABG) is a non-robotic, multi-vessel CABG operation performed via a small left thoracotomy. Established in 2005, it has become more commonly performed and better validated, with recent studies demonstrating a safe learning curve and favorable graft patency. We report a combined, two-center experience with the first 1,038 consecutive patients who received this operation.
Methods: Patients (N=1,038) underwent MICS CABG through a 4-6 cm thoracotomy in the left 4th or 5th intercostal space. The left internal thoracic artery was harvested under direct vision, proximal anastomoses were constructed on the ascending aorta, and all myocardial territories were accessed for distal anastomoses with an epicardial stabilizer and/or apical positioner. Patients were followed with regards to survival and adverse cardiac events, up to a maximum of 8.0 years (mean 2.9±2.0 years).
Results: At operation, mean patient age was 63.9±10.9 years and 255 patients were female (24.6%). Diabetes was prevalent in 328 patients (31.6%), and 470 (45.3%) had some degree of LV dysfunction. A mean of 2.2±0.9 grafts were performed. Peripheral cardiopulmonary bypass assistance was used in 111 patients (10.7%), with no major complication. Perioperative mortality was 9 patients (0.9%). There were 26 (2.6%) conversions to sternotomy, and 30 (2.9%) reoperations for bleeding. New onset atrial fibrillation developed in 215 patients (20.7%). No deep wound infection occurred. At 2.9 years postoperatively, overall survival after MICS CABG was 96.1±0.9%, with 53 patients (5.1%) having undergone percutaneous coronary intervention.
Conclusions: MICS CABG constitutes an attractive, feasible, and increasingly established minimally invasive alternative in patients who require CABG. Rates of conversion to sternotomy and complications are low, making it a safe, reproducible operation that yields survival and durability results comparable to conventional CABG.
C6 A Paradigm Shift in Coronary Revascularization: 1021 Consecutive Robot-Assisted Coronary Artery Bypass Procedures
Francis P. Sutter, DO, MaryAnn C. Wertan. Lankenau Hospital, Wynnewood, PA USA.
Objective: Robotic-assisted technology is responsible for introducing a new era in coronary revascularization. Significant benefits of the robotic approach include: survival benefit of LIMA to LAD, avoiding heart-lung machine with beating heart surgery performed and reducing trauma to patient via a non-rib spreading, mini-thoracotomy. We show a paradigm shift in our institution’s treatment of coronary revascularization.
Methods: We describe a single-center experience of minimally invasive robotic coronary surgery from inception, May, 2005, through December, 2013. Our technique places the endoscopic port over the LAD target, with subsequent port conversion to “precision incision” mini-thoracotomy allowing beating heart coronary bypass to be performed.
Results: 1021 consecutive robot mini-thoracotomy CABG is reported; results are seen in C6-1 below. A mean incision size of 4.2 cm was used in the last 732 cases. 397 of 1021 underwent hybrid revascularization; subset revealed LIMA patency 96.6% in those having postoperative catheterization, n = 119. Importantly, since 2007, robotic CABG is routinely performed and accounts for 41.5%-51.8% of all CABG performed at our institution. Similarly and collaboratively, interventional cardiologists have embraced robotic CABG as a valuable alternative; for the past 3 years, 46-54% of our robot CABG population underwent staged hybrid revascularization.
Conclusions: This technique is safe, reproducible and yields outstanding results. It has saved lives, even offering an alternative to sickest patients with multivessel disease, clearly demonstrating the true value of LIMA to LAD. Our center has had a dramatic paradigm shift in the treatment of CAD with half of all CABG at our institution having the robotic precision incision.
C7 Short- and Long-Term Results of Minimally Invasive Direct Coronary Artery Bypass Versus Full Sternotomy Revascularization in Isolated Left Anterior Descending Artery Disease: A Propensity-Score Adjusted Comparison:
TABLE C6-1 Patient C...Image Tools
Eman Alkizwini, Umberto Benedetto, Shahzad G. Raja, Mohamed Amrani. Harefield Hospital, London, United Kingdom.
Objective: Minimally invasive direct coronary artery bypass (MIDCAB) has been proposed as an attractive alternative to full sternotomy (FS) revascularization in isolated left anterior descending (LAD) artery disease not suitable for percutaneous coronary intervention. However, surgeons are still reluctant to perform MIDCAB owing to concerns about early and late outcomes. We aimed to compare short- and long-term outcomes after MIDCAB versus FS revascularization.
Methods: Prospectively collected data from institutional database were reviewed. Data for late mortality was obtained from the General Register Office. MIDCAB was performed in 316 patients while 161 had FS, according to the surgeon’s preference, among 477 patients with isolated LAD disease. Inverse propensity-score weighting was used to estimate treatment effects on short- and long-term outcomes.
Results: In the propensity-score adjusted analysis, MIDCAB versus FS revascularization was associated with a trend towards better short-term results including operative mortality (0.6% vs. 1.6%; P=.2), postoperative dialysis (1.5% vs. 4.5%; P=.09), re-intubation (0.9% vs. 3.3%; P=.1) and surgical site wound infection (0.1% vs. 1.2%; P=0.04). Mean length of hospital stay did not differ between the two groups. After a mean follow-up time of 2220 days (range 3 to 4450), MIDCAB did not affect late mortality (HR 0.70; 95% CI 0.27-1.82; P=0.47), need for repeat revascularization (HR 1.26; 95% CI 0.50 - 3.13; P=0.62) and the composite of death and repeat revascularization (HR 0.94; 95% CI 0.49 - 1.49; P=0.92; (Fig. C7-1).
Conclusions: MIDCAB was associated with a trend towards better short term outcomes and excellent long term results comparable to FS revascularization. According to these findings, surgeons should not be reluctant to perform MIDCAB in isolated LAD disease.
FIGURE C7-1. MIDCAB ...Image Tools
C8 Long-Term Survival Advantage of OPCAB over PCI with 1st Generation DES in Triple Vessel Coronary Artery Disease
Gijong Yi, Hyun-Chel Joo, Young-Nam Youn, Kyung-Jong Yoo. Yonsei University Gangnam Severance Hospital, Seoul, Republic of Korea.
Objective: Recently published large volume randomized trials and registry data showed survival advantage of surgical coronary revascularization compared to percutaneous coronary intervention (PCI) after long-term follow-up. We evaluated long-term survival between off-pump surgical revascularization (OPCAB) and PCI with 1st generation DES to assess whether there is a survival advantage in the surgery group.
Methods: From 2003 to 2008, 2498 patients underwent OPCAB or PCI with DES as their initial revascularization therapy (OPCAB group (n=981) vs. PCI group (n=1517)). Emergency and life-saving procedures were excluded. Study end-points were all-cause mortality and major adverse cardiac and cerebrovascular event (MACCE). Mean follow-up duration was 6.7 years and follow-up rate was 97.4%. We evaluated real-world comparison (n=2498) and propensity-score matched population comparison (n=1436).
Results: Early mortality was comparable between the two groups. In real-world comparison, overall survival at 10 years was 86.2±2.1% in the OPCAB group and 81.7±1.1% in the PCI group (p<0.001). Freedom from MACCE rates were 77.5±1.7% in the OPCAB group and 60.7±1.5% in the PCI group at 10 years (p<0.001). In the propensity-score matched population, 10-year survival rates were 79.7 ±2.5% in the OPCAB group and 74.2 ±2.0% in the PCI group (p=0.001). 10-year freedom from MACCE rate was better in the OPCAB group (66.4 ±2.9 vs. 46.7±3.8%p<0.001) and the determining factors were all-cause mortality (p=0.001), nonfatal MI (p=0.005) and target vessel revascularization (p<0.001).
Conclusions: The OPCAB showed better overall survival compared to 1st generation DES after a mean of 6.7 years follow-up. Freedom from MACCE rate was better in the OPCAB group mainly due to the lower incidence of mortality, nonfatal MI and target vessel revascularization.
CMP3 15-Year Experience with Robotic-Assisted Coronary Artery Bypass Grafting with Post-Operative Angiography
Bob Kiaii1, Michael Chu1,Reiza Rayman1, StuartA. Swinamer1, Stephanie A. Fox1, Wojciech B. Dobkowski1, George Jablonsky1, Kumar Sridhar1, Patrick Teefy1, Alan Menkis2, Douglas Boyd3. 1London Health Sciences Center, London, ON Canada, 2St. Boniface Hospital, Winnipeg, MB Canada, 3University of California Davis, Sacramento, CA USA.
Objective: Minimally invasive coronary artery bypass grafting (CABG) is a rapidly evolving technology that has been shown to increase patient satisfaction and to reduce surgical morbidity and recovery times. Therefore, we present our institutional experience with minimally invasive robotic-assisted CABG with post-operative cardiac catheterization.
Methods: The study cohort includes all patients who underwent robotic-assisted CABG between September, 1998, and December, 2013. All internal thoracic arteries were harvested with robotic-assistance, and anastomoses were manually constructed through a small anterior non-rib spreading incision or closed chest robotic assistance without cardiopulmonary bypass on the beating heart. Angiographic confirmation of graft patency was performed either immediately within the same operative suite equipped with angiographic equipment, or next day in the cardiac catheterization lab.
Results: Since 1998, a total of 509 patients underwent robotic-assisted minimally invasive CABG. Total of 373 patients were males and mean age was 60 years. There were 2 deaths (0.4%) secondary to respiratory complications and 6 wound infections (1.2%). Seven (1.4%) patients required re-exploration for bleeding. Median length of stay in the intensive care unit was 1 day and length of hospital stay was 4 days. The patency rate of left internal thoracic artery (LITA) grafts to the left anterior descending artery (LAD) was 98.6% with 7 occluded grafts, which underwent revision.
Conclusions: Robotic-assisted CABG is a safe and feasible alternative approach to surgical revascularization. It has the potential of reducing morbidity of surgery by reducing infection and bleeding. Post-operative assessment with cardiac catheterization enables the achievement of a very high postoperative patency rate.
CMP4 Long-Term Follow-up for Grafts Patency of Totally Robotic Coronary Artery Bypass Grafting on Beating Heart
Changqing Gao, Ming Yang. PLA General Hospital, Beijing, China.
Objective: The totally robotic coronary artery bypass grafting on beating heart (BH TECAB) is the most minimally invasive procedure for coronary artery bypass graft. The long-term follow-up for graft patency of BH TECAB is needed to determine.
Methods: In 650 cases of robotic cardiac operations, in which 100 patients underwent selective BH TECAB procedures from 2007 to 2013 in General Hospital. There were 86 male and 14 female with a median age of 57 (range, 33∼79) years old. Through 3 ports, incisions in the left chest, the internal thoracic artery (ITA) were harvested robotically in a skeletonized fashion. And totally robotic ITA to target vessel anastomosis was performed using U-Clip on beating heart. The coronary angiography or CTA was performed to evaluate the patency of ITA graft before discharge and 1 to 5 years postoperatively. The patients with multiple vessels diseases accepted a staged hybrid revascularization. The clinical follow-up for major adverse cardiac events (MACE) as cardiac death, acute myocardial infarction and target lesion revascularization was performed.
Results: All the patients accepted successfully BH TECAB procedure, in which 18 patients received hybrid procedures. The mean operation time was 150.1±28.9 (120 to 188) minutes. The average coronary occlusion time and anastomosis time were 19.5±6.7 minutes (7 to 41) and 9.9±4.1 (5∼21) minutes respectively. The significant learning curves were observed for anastomosis and operation time. The average graft flow was 35.8±20.0 ml/min (10 to 103). No patient had angina after surgery. Before discharge, all the patients accepted CTA or coronary angiography follow-up. Both angiography and CTA scan showed 98.1% graft patency and unexpectedly, ITA graft developed a collateral branch in 2 patients. After discharge, all patients were followed up by CTA scan, average follow-up time was 37.6 (1∼79) month. One graft occlusion was found at 1 year postoperatively. No more graft occlusion was found at 3 to 5 years. The clinical outcome demonstrated 100% survival, freedom from angina and any form of coronary revascularization.
Conclusions: BH-TECAB is a safe procedure in selected patients, and has excellent long-term patency.
CMP5 Impact of Aortic Partial Clamping and All-Arterial Grafting on Stroke and Death after OPCAB
Emmanuel Moss1, Michael E. Halkos2, Patrick Kilgo3, Vinod Thourani2, Omar Lattouf2, John D. Puskas2. 1Emory University, Atlanta, GA USA, 2Emory University Hospital Midtown, Atlanta, GA USA, 3Emory University, Rollins School of Public Health, Atlanta, GA USA.
Objective: To assess the impact of aortic partial occlusion clamping and all-arterial grafting on stroke and death after off-pump coronary artery bypass grafting (OPCAB).
Methods: Clinical and demographic data were analyzed from the STS Adult Cardiac Database for all primary, isolated, multi-vessel, OPCAB patients from a large academic hospital system between December, 2004, and November, 2013. Patients converted to CPB were excluded. The primary variables of interest were (1) whether a partial clamp was used (CLAMP) and, (2) whether all of the grafts were arterial (ART). A propensity-scoring approach estimated both (1) a patient’s likelihood of being clamped and, (2) patient’s likelihood of receiving all arterial grafts, based on 37 preoperative variables. Separate multivariable logistic regression models were used to determine the effect of CLAMP and ART on post-operative (30-day) incidence of stroke and other outcomes, adjusted for the propensity-score. Adjusted odds ratios (AOR) and 95% confidence intervals (CI) were calculated. Also, long-term survival was compared between groups using Cox regression and Kaplan-Meier (KM) curves.
Results: CLAMP patients tended to be younger (62.7 vs. 65.3) with lower preoperative risks of death (1.90% vs. 2.52%) and stroke (1.44% vs. 1.86%). See Table CMP5-1. After multivariable regression propensity adjustment, CLAMP was associated with a statistically insignificant 47% increase in odds of stroke (AOR=1.47, 95% CI 0.83-2.61p=0.19). ART was associated with a statistically insignificant 72% decrease in the odds of stroke (AOR=0.28, 95% CI 0.04-2.04p=0.21). After multivariable Cox adjustment, long-term survival was similar between CLAMP and No CLAMP groups (AHR=0.87, 95% CI 0.73-1.04p=0.12).
Conclusions: Performing all-arterial grafting and avoiding aortic clamping were associated with statistically insignificant reductions in adjusted risk of stroke and death after OPCAB.
CMP6 Total Arterial Revascularization on OPCABG with the Exclusive Use of Two Internal Mammary Arteries: A Single-Center Ten-Year Study Analysis
TABLE CMP5-1 Observe...Image Tools
Sotirios N. Prapas, Ioannis Panagiotopoulos, Ioannis Linardakis, Konstantinos Katsavrias, Victoras Panagiotakopoulos. Henry Dunant Hospital, Athens, Greece.
Objective: Our aim is to record and present our ten-year experience on total arterial revascularization treatment of coronary artery disease with the exclusive use of both internal mammary arteries on OPCABG.
Methods: From February, 2001, through September, 2011, 1,077 patients underwent a total arterial revascularization OPCABG procedure with the use of both internal mammary arteries. The “non-touch aorta technique” was utilized and the “π-graft”, the “y- graft”, “t-graft”, “λ-graft” and “ψ-graft” techniques were employed. The mean age of our population was 66 years, with a male majority of 84.5%. 72 patients were diabetics (6.7%), 260 patients had LV dysfunction (EF<45%), 73 (7.2%) with renal insufficiency of which 19 underwent dialysis (1.8%).
Results: The mean number of peripheral arterial anastomoses consisted of 2.8/patient. 569 patients had sequential anastomoses performed with a mean 1.35/patient. Atrial fibrillation was observed in 206 patients (19.1%). IABP was employed on 19 patients preoperatively and 14 patients postoperatively. Emergency revision was performed on 17 patients (1.6%), 14 (1.3%) for hemorrhage and 3 for hemodynamic instability (<0.3%). Sixteen patients remained under prolonged intubation >48 hrs. (1.6%). Postoperative neurological complications were observed in 5 patients (<0.5%) with stroke. Twenty-two patients (2%) presented sternal wound infection, 10 of which were diabetics (2 insulin and 8 non-insulin dependent). GI complications were observed in 18 patients (1.8%). Psychiatric help was assessed on 8 patients (0.7%). Long-term mortality consisted of 25 and hospital mortality of 7 patients (<1%).
Conclusions: Total arterial revascularization, with the use of both internal mammary arteries, on off-pump beating heart surgery is a feasible combination with excellent results when performed by experienced cardiac surgeons.
C9 The Transapical Approach for TEVAR
Tamer Ghazy1, Adrian Mahlmann2, Ahmed Ouda1, Ralf-Thorsten Hoffmann2, NorbertWeiss2,KlausMatschke1, UtzKappert1. 1DresdenHeart Center,Dresden University of Technology, Dresden, Germany, 2University Hospital Carl Gustav Carus Dresden, Dresden, Germany.
Objective: To analyze the feasibility of using a transapical approach for TEVAR in patients with unfavorable femoral access.
Methods: From January, 2011, through December, 2013, 9 patients received TEVAR in our institution via transapical approach. The indications were distal arch and thoracic descending aneurysms (4 patients), Stanford type B aortic dissection (3 patients), and penetrating aortic ulcers in 2 patients (one in the descending aorta and the other in the ascending aorta). Preparation of the access point was performed similar to the standard transapical approach for TAVR. Deployment of the stent was performed under rapid ventricular pacing.
Results: The mean operative time was 83±19 min. Over-stenting of the left subclavian was necessary in one patient. There were no intraoperative complications, no intra- or postoperative mortality and no postoperative neurological deficit. A postoperative bleeding requiring 2nd look was encountered in 1 patient. The mean ICU stay was 3±2 days. The mean hospital stay was 9±4 days.
Conclusions: The transapical approach to TEVAR could be considered an alternative approach. Yet it is to be considered only for highly selected cases. This approach provides a shorter, and an always non-dissected access point for the ascending aorta, allowing for easier and more precise placement in such cases. Further research is needed to identify the indication, complications and technical difficulties that its use may pose, as well as explore the possibility of encouraging the medical industry to develop suitable stents and delivery systems.
C10 Endovascular Treatment of the Ascending Aorta: A Feasibility Study in a Porcine Model for Evaluation of Transcardiac Access Routes
Sabine Wipper, E. Sebastian Debus, Christina Lohrenz, Oliver Ahlbrecht, Christian Detter, Tilo Kölbel. University Heart Center Hamburg Eppendorf, Hamburg, Germany.
Objective: Endovascular treatment of the ascending aorta and the aortic arch is currently performed in selective patients. Multiple tortuous segments may lead to inability to advance or deploy endograft and may prohibit precise stent graft placement. Aim of this study was to compare feasibility and hemodynamic effects of conventional retrograde-transfemoral (TFA) to antegrade-transseptal access (TSA) and antegrade-transapical access (TAA) using through-and-through guidewire technique to the ascending aorta for endograft introduction in pigs.
Methods: TFA (n=6, 52±8kgBW) was compared to TAA (n=6, 54±8kgBW) and TSA (n=6 pigs, 54±6kgBW). Custom-made endografts (polyester-tube + 2 nitinol-stents, 24×32 mm) were advanced and deployed under fluoroscopy into the ascending aorta. Myocardial and cerebral perfusion were assessed by fluorescent-microspheres (FM). Transit-time flow measurement (TTFM) on the carotid artery was performed. Hemodynamic parameters were evaluated during baseline (T1), sheath forwarding (T2), endograft deployment (T3) and after retraction of the sheath (T4).
Results: Endograft deployment was feasible in all animals. All coronary arteries remained patent. Cardiac output, heart rate and central-venous-pressure were stable throughout the whole study in all animals (p=n.s.). During T2 transient hemodynamic alteration due to severe valve insufficiency occurred during TSA and TAA reflected by significantly higher ratio between pulmonary-arterial and mean-arterial pressure (p<0.05), while values remained stable during TFA. During T4 hemodynamic stability recovered within ten minutes in all animals. The innominate artery was partially occluded in 4 animals in each group (66%), reflected by reduced TTFM (p<0.05). There was no periprocedural deterioration of myocardial end cerebral perfusion assessed by FM. Endograft deployment during TAA lasted significantly shorter than in TSA and TFA.
Conclusions: TSA, TFA and TAA to the ascending aorta are feasible in a porcine model. Transient hemodynamic alteration in TSA and TAA recovered to near preoperative values. TAA caused less hemodynamic alteration. Transcardiac-access might be an alternative route for selective patients in the future.
CMP7 Emergent TEVAR for Acute Aortic Syndromes Involving the Descending Thoracic Aorta
Bradley G. Leshnower, Ravi K. Veeraswamy, Yazan M. Duwayri, Edward P. Chen. Emory University School of Medicine, Atlanta, GA USA
Objective: Traditional surgical treatment of acute aortic syndromes involving the descending thoracic aorta (DTA) requires open aortic exposure with the use of cardiopulmonary bypass and is associated with high morbidity and mortality. Thoracic endovascular aortic repair (TEVAR) offers a rapid, minimally invasive solution to these lethal presentations. We reviewed our experience with TEVAR for the treatment of acute DTA pathology.
Methods: From January, 2011, through December, 2013, 110 TEVAR procedures were performed at a single US academic institution. 45 (41%) patients underwent emergent TEVAR for treatment of acute DTA pathology. Traumatic aortic transections were excluded from this review.
Results: The mean age of all patients was 60±13 years. 8 (18%) patients required a zone 2 landing, with a single patient receiving a carotid-subclavian bypass. DTA pathology treated with emergent TEVAR consisted of: acute complicated DeBakey III aortic dissection (n=26), symptomatic penetrating aortic ulcer with intramural hematoma (n=10), ruptured aneurysm (n=5), aortobronchial fistula (n=3), and rapidly expanding pseudoaneurysm (n=1). In the dissection population, 11 patients presented with malperfusion, of which 3 required additional branch vessel stenting to restore end-organ perfusion. TEVAR was delivered via femoral (n=42), iliac (n=2) and direct abdominal aortic (n=1) access. 4 (8.9%) patients suffered in-hospital mortality. 3 patients died of aortic rupture distal to the stent graft and one patient died of massive pulmonary embolism. 2 of the 3 patients who were paraplegic in the postoperative period initially presented with paraplegia, which was unresolved after TEVAR. A single patient suffered transient paraparesis, which was completely resolved with CSF drainage. 1 patient suffered a postoperative stroke and 1 patient required new onset dialysis. 7 (16%) patients, all of whom presented with dissection, required reintervention during the study period. Of these 7 patients, 3 patients underwent proximal aortic surgery, 1 patient required open DTA replacement, and 3 patients required further endovascular procedures.
Conclusions: Emergent intervention involving the DTA can be performed using TEVAR with acceptable operative risk. Patients with acute DeBakey III dissection must be monitored closely as early reintervention is often warranted. These data suggest that TEVAR is a highly effective treatment strategy for acute aortic syndromes of the DTA.
CMP8 Is Spinal Cord Ischemia following Total Aortic Arch Replacement and Endovascular Stenting of the Descending Thoracic Aorta (TEVAR) Still an Issue? Pathophysiological Investigations in a Porcine Model
Peter Lukas Haldenwang1, LorineHäuser1, Nora Prochnow2,Andreas Baumann1, Dirk Buchwald1, I. Schmitz1, Markus Schlömicher1, Justus Strauch1. 1BG University Hospital Bergmannsheil Bochum, Bochum, Germany, 2Department of Neuroanatomy and Molecular Brain Research, Ruhr-University of Bochum, Bochum, Germany.
Objective: Open aortic arch replacement and endovascular stenting of the descending thoracic aorta (TEVAR) represent the therapies of choice for complicated aortic diseases. Aim of our study was to analyze in an established animal model if the combination of open arch replacement with extended selective cerebral perfusion (SCP) and an endovascular stenting of the descending aorta (TEVAR) and may cause spinal cord ischemia.
Methods: Fourteen pigs (41±3kg) were cooled on CPB to 28°C. After clamping of the aortic arch, SCP was established for 90 min; randomly, in n=7 animals, the left-sided vertebral artery as well as the T4-T13 thoracic segmental arteries (TSA) were clipped, in order to simulate a TEVAR procedure, whereas the TSA of the other n=7 animals remained untouched. After systemic reperfusion and CPB weaning, hemodynamic data were registered for 120 min. Microspheres were injected at baseline, reaching of 28°C, during SCP, respectively at 60 and 120 min off-CPB for spinal cord blood flow (SCBF) calculation. Via trans-cranial stimulation motor-evoked potentials (MEP) were assessed at the same time points. After sacrifice, the thoracic and lumbar spinal cord was analyzed histologically using transmission electron microscopy (TEM), for necrosis staging and light microscopy for necrosis grading using a 9-point schematic grading system (Kleinman-Score: 0=normal, 8= total necrosis).
Results: During SCP the SCBF presented physiologic values (5.9±2.4 ml/min/100g) for T4-T13, but showed a significant decrease in the L1-L5 region (from 8.4±4.3 to 1.3±1.5 ml/min/100g). After CPB-weaning a hyperperfusion was seen in both groups. The MEP had a significant deeper amplitude decrease for L1-L5 in the TSA-clipped-animals: 59±7% vs. 84±15% (vastus medialis) and 48±6% vs. 82 ± 26% (tibialis anterior). MEP-amplitude recovered only in the non-clipped-group. The histologic examination showed early ischemic alterations of the cytoplasm and advanced stages of necrosis (TEM) in 12 of 14 animals. Lumbar ischemia rate was higher in the TSA-clipped-animals (Kleinman-Score: 6.0±0.6 vs. 2.5 ± 2.3).
Conclusions: 90 min of SCP provide sufficient spinal cord protection during arch replacement at 28°C. In combination with TEVAR of the descending aorta, the lumbar spinal cord perfusion may be altered, which causes functional and structural damage.
CMP9 Hybrid Repair for Complex Aortic Arch Disease: How to Prevent Cerebrovascular Complication in Total Debranching TEVAR
Tomohiro Mizuno, Tsuyoshi Hachimaru, Keiji Oi, Daiju Watanabe, Hidehito Kuroki, Tatsuki Fujiwara, Shogo Sakurai, Kenji Sakai, Hirokuni Arai. Tokyo Medical and Dental University, Graduate School of Medicine, Tokyo, Japan.
Objective: Endovascular repair for aortic arch disease has been dramatically progressing in the last decade, and aortic arch disease can be now treated without cardiopulmonary bypass (CPB). However, there remain some technical problems such as cerebrovascular emboli and aortic dissection.
Methods: We performed 6 total debranching thoracic endovascular aortic repair (TEVAR) to zone 0 for complex aortic arch disease in the last one year. We always place axillo-axillar (A-A) bypass before reconstructing the arch vessels because A-A bypass can prevent cerebral emboli and ischemia at the time of reconstruction. Our surgical procedure was as follows: 1. Axillo-axillar (A-A) bypass is placed. 2. The proximal anastomosis of the debranching grafts is placed at the ascending aorta as proximal as possible to secure the landing zone. 3. The brachiocepharic artery is reconstructed by direct clamping. 4. The left carotid artery is reconstructed. 5. The left subclavian artery is ligated. 6. The stent graft is deployed. When CPB is needed, A-A bypass graft is used for arterial cannulation.
Results: Mean age was 75.0 years old (63 to 82). There were 3 true aneurysms, 2 subacute aortic dissections with an ulcer-like projection and 1 chronic aortic dissection. Three patients had ischemic heart disease. Total debranching TEVAR without CPB was performed in 3 patients. CPB was used in 3 patients because of the replacement of the ascending aorta and the aortic valve (1) and the difficulty of the aortic partial clamp (2). Coronary artery bypass grafting was performed in 2 patients. There was no endoleak and no neurologic complication. Localized aortic dissection was recognized at the proximal anastomotic site in 1 patient, and the ascending aorta was replaced 7 days after total debranching TEVAR. Although the duration of follow-up was still short (4-16 months), all patients were survived and there was no aorta-related complication.
Conclusions: Total debranching TEVAR with axillo-axillar bypass is safe and useful to prevent cerebrovascular complication, but there remain some aorta-related complications that should be solved.
CV1 Endoscopic Assisted Robotic Aortic Thrombectomy and Aortobiiliac Bypass
Cem Alhan, Sahin Senay, Hakan Kaya, Ahmet U. Gullu, Muharrem Kocyigit, Ilknur Erguner, Tayfun Karahasanoglu. Acibadem University, School ofMedicine, Istanbul, Turkey.
Objective: In this video, we present the details of our technique in a patient with infrarenal aortic obstruction treated by endoscopic assisted robotic aortic thrombectomy and aortobiiliac bypass.
Methods: A forty-seven year old man diagnosed with obstruction at infrarenal aorta undergone to endoscopic assisted robotic surgery. The aortic thrombus and plaque were removed from the aortic lumen and 14-7 mm polytetrafluoroethylene prosthesis (Gore-Tex, Gore Medical) was introduced into the retroperitoneal cavity. The two robotic arms were used to perform the aorta to graft anastomosis in an end-to-side fashion with PTFE suture (Gore-Tex, Gore Medical).
Results: The proximal and distal anastomosis was performed within 20 min., 13 min., 13 min., respectively. Total operative time was 360 minutes. The graft was patent at CT angiography on postoperative 3rd day. The patient was discharged from the hospital 4 days postoperatively and he is still in good condition at 1-year follow-up.
Conclusions: Laparoscopic or robotic techniques in vascular surgery has not gained widespread acceptance or applicability as it is commonly used in general or urologic surgery. However, the described method presented in this video may find broader application with this advancing technology.
CMP10 Thoracic Endovascular Aortic Repair Using the Percutaneous Technique or Open Exposure: A Comparison of Early Outcomes
Marshall T. Bell, Lisa S. Foley, Daine T. Bennett, Rajan Gupta, Omid Jazaeri, Paul J. Rochon, T. Brett Reece. University of Colorado, Aurora, CO USA.
Objective: TEVAR has become the primary mode of treatment for TAA over the last 10 years. Traditionally, this has required open exposure of the common femoral artery for sheath delivery. Devices for percutaneous closure have been applied EVAR; however, due to larger sheath sizes, this technology has lagged in TEVAR. We hypothesized that percutaneous techniques could be applied to TEVAR and that this minimally invasive technique will improve early outcomes following intervention.
Methods: A retrospective chart review of fifty-five patients undergoing TEVAR from February, 2006, to December, 2012, was conducted. Twenty-six patients who underwent attempted total percutaneous TEVAR using preclosure technique were compared to twenty-nine patients that had received TEVAR with standard surgical cut down. All patients in the percutaneous group received preoperative CTA or intraoperative pelvic angiogram to determine appropriateness of percutaneous closure. Outcomes measured included successful percutaneous closure, technical success rate, early complication rates, and hospital course.
Results: Following TEVAR there was no difference in technical success. Of the total percutaneous group, 11.5% required conversion to surgical cut down for closure. Reason for conversion included need for hemostasis 7.7% and vessel occlusion 3.8%. There was no difference in ICU or hospital stay. Patients that had received standard surgical cut down had a significantly higher incidence of postoperative hematoma and wound infections (p<0.02) when compared to the total percutaneous approach.
Conclusions: Total percutaneous approach for TEVAR can be applied easily and with minimal risk to the patient when used in appropriate patients. Additionally, these approaches can minimize the risk of post-operative wound complications. With some consideration, percutaneous closure of large sheath access for TEVAR is safe and effective.
C11 Current Trends in Robotic Vascular Surgery
Petr Stadler. Na Homolce Hospital, Praha, Czech Republic.
Objective: The feasibility of laparoscopic aortic surgery has been adequately demonstrated. Our clinical experience with robot-assisted aortoiliac reconstruction for occlusive diseases, aneurysms, endoleak II treatment and hybrid procedures performed using the da Vinci system is herein described.
Methods: Between November, 2005, and August, 2013, we performed 290 robot-assisted vascular procedures. 212 patients were prospectively evaluated for occlusive diseases, 57 patients for abdominal aortic aneurysm, four for a common iliac artery aneurysm, three for a splenic artery aneurysm, one for an internal mammary artery aneurysm, five for hybrid procedures, and eight for endoleak II treatment post EVAR. The robotic system was applied to construct the vascular anastomosis, for the thromboendarterectomy, for the aorto-iliac reconstruction with a closure patch, for dissection of the splenic artery, and for the posterior peritoneal suture. A combination of conventional laparoscopic surgeries and robotic surgeries were initially included. A modified, fully-robotic approach without laparoscopic surgery was used in the last 120 cases in our series.
Results: 279 cases (96%) were successfully completed robotically; one patient’s surgery was discontinued during laparoscopy due to heavy aortic calcification. In ten patients (3.4%) conversion was necessary. The thirty-day mortality rate was 0.3%, and early non-lethal postoperative complications were observed in six patients (2%).
Conclusions: Our experience with robot-assisted laparoscopic surgery has demonstrated the feasibility of this technique for occlusive diseases, aneurysms, endoleak II treatment post EVAR and hybrid procedures. The da Vinci robotic system facilitated the creation of the aortic anastomosis, (Fig. C11-1) and shortened the aortic-clamping time as compared to purely laparoscopic techniques.
C12 Staged Hybrid Approach for Treatment of Persistent Atrial Fibrillation: One-Year Results of Hybrid Procedure versus Catheter Ablation
FIGURE C11-1. Robot-...Image Tools
Hyoung Woo Chang, Dong Seop Jeong, Seung-Jung Park, Young Keun On, June Soo Kim, Young Tak Lee, Pyo Won Park. Samsung Medical Center, Seoul, Republic of Korea.
Objective: Thoracoscopic ablation following post-procedural endocardial confirmation (staged hybrid) overcomes the limitations of both techniques for treatment of atrial fibrillation (AF). We compared one-year results of staged hybrid procedure with catheter ablation in persistent AF patients.
Methods: From 2010 to 2013, 118 patients who underwent staged hybrid procedure (Hybrid group, n=54) or catheter ablation (Ablation group, n=64) for persistent AF were prospectively enrolled. Thoracoscopic ablation included pulmonary vein isolation, ganglionated plexus ablation, division of Marshall ligament and resection of left atrial appendage. An electrophysiologic study was performed on postoperative 4th day. All patients underwent 24-hour Holter monitoring at 3, 6, and 12 months.
TABLE C12-1. Preoper...Image Tools
Results: No intergroup difference was observed in preoperative characteristics (Table C12-1). During post-procedural confirmation, additional endocardial ablations were required in 11 patients (20%). Residual potentials were primarily found in superior ridge of upper pulmonary veins and inferior ridge of the right lower pulmonary vein (14 of 21 sites, 66.7%). In the hybrid group, 50 patients (92.5%) showed normal sinus rhythm, and freedom from AF recurrence without antiarrhythmic drugs was 55.7±7.6% at one year. Freedom from AF recurrence at one year was higher in the hybrid group (Fig. C12-1). In overall populations, ablation only was an independent predictor for AF recurrence (p=0.015, hazard ratio (HR) =3.9, 95% confidence interval (CI) =1.3-11.5). In the hybrid group, independent predictors for AF recurrence were CHAD2 score (p=0.011, HR=3.4, 95% CI=1.4-8.8) and absence of sinus conversion during thoracoscopic ablation (p=0.018, HR=36.0, 95% CI=1.9-690).
Conclusions: The success of the hybrid group at one year was superior to the ablation group. We suggest that the hybrid procedure could be considered as a primary treatment in persistent AF patients.
CMP11 Successful Endoscopic Surgical Ablation in Persistent Atrial Fibrillation is Associated with Improved Atrial Function at Short-Term Follow-up
FIGURE C12-1. Compar...Image Tools
Gianluigi Bisleri, Fabrizio Rosati, Ermanna Chiari, Paolo Della Pina, Claudio Muneretto. University of Brescia Medical School, Brescia, Italy.
Objective: Minimally invasive surgical treatment of stand-alone atrial fibrillation has gained popularity especially in presence of persistent atrial fibrillation, thanks to the high rates of success technical feasibility and reduced rate of complications when compared to the original Cox-Maze procedure. Nevertheless, there is paucity of data about the atrial transport function following successful restoration of sinus rhythm (SR) by means of a totally endoscopic, epicardial box lesion set.
Methods: Among 60 patients with persistent AF scheduled to undergo closed-chest, epicardial beating heart surgical ablation (box lesion set) with a radiofrequency device, a comprehensive echocardiographic assessment of the left atrial (LA) function was performed either pre- and postoperatively; the following parameters were evaluated: LVEF, LA diameter-area-volume, LA total - passive and active emptying fraction, E/A ratio, A’, E’/E’ ratio, deceleration time, LA systolic - early and late diastolic strain. Postoperative evaluation was performed at 6 months following surgical ablation: only 49 patients with stable sinus rhythm were included in the analysis in order to evaluate the impact of the box lesion set following SR restoration.
Results: At 6-month follow-up, there was no considerable difference in the LVEF (pre=61.3±7.2% vs. post=63.6±8.7%; p=0.051); however, there was a significant reduction either in terms of LA diameter (pre=47.4±4.2 mm vs. post=45.8±3.6 mm; p=0.012), LA area (pre=28.2±4 cm2 vs. post=26.1±4.9 cm2; p=0.007), LA maximal volume (pre=103.5±29.2 mL vs. post=95.2±27.1 mL; p=0.0024), LA minimum volume (pre=50.8±14.8 mL vs. post=46.1±11.3mL; p=0.0023) while a considerable improvement in deceleration time (pre=192.7±64.4 ms vs. post=232.9±132.5 ms; p=0.0023). Moreover, there was a recovery of atrial transport function as demonstrated by the recovery active LA emptying fraction of 14.6±4%, a normalization of the E/A ratio (1.67±0.50) and the A’ value (6.4±2.7).
Conclusions: Following successful surgical ablation with a box lesion set and stable restoration of sinus rhythm, recovery of an effective atrial transport function could be detected during the first 6 months postoperatively. Longer term analysis is required to confirm further potential improvements over the follow-up period.
CMP12 Video-Assisted Pericardioscopic Surgery for Epimyocardial Lead Implantation - From Bench to Human Application
NimaHatam1, Frederik Steiner1, Karl Mischke2, Andreas Goetzenich1, Jan Spillner1, Ruediger Autschbach1. 1Cardiovascular and Thoracic Surgery, University Hospital RWTH Aachen, Aachen, Germany, 2Cardiology, Pneumology and Angiology, University Hospital RWTH Aachen, Aachen, Germany.
Objective: The expansion of pacemaker therapy has led to an increasing number of cases, where the standard transvenous approach does not apply and alternative, more invasive methods are used for lead implantation. Our goal was to assess and to refine the minimal-invasive technique of video-assisted pericardioscopic surgery (VAPS) and translate it to a clinical applicable approach.
Methods: In an acute (porcine, n=10) and chronic (ovine, n=6) animal model rigid and small-caliber flexible endoscopy was used from a subxiphoid approach following a standardized protocol to implant a newly designed 4 F epicardial screw-in lead. Safety and latitude inside the pericardial cavity using VAPS was studied using a specific trocar, pericardiotomy instrument and delivery catheter, which were developed during the acute trial and their performance tested. In the chronic trial feasibility of reoperation and lead performance were assessed. Epicardial screw-in leads were implanted onto each chamber (Σ: 16), where left-sided leads were representatively connected to a dual-chamber pacemaker for follow-up assessments, held after 3, 6 and 12 months.
Results: The subxiphoid approach presented as very effective for VAPS accessing the pericardium within a short distance. Access to the implantation sites was quick (< 10 min) with overall procedural duration under 60 minutes. There was no bleeding or myocardial injury. The use of bare-metal instruments inside the pericardial cavity without insulation frequently led to malignant arrhythmia leading to one death in the acute group. Exclusive flexible endoscopy was not applicable due to poor navigation and maneuvering. Using the trocar arrhythmia and poor navigation were resolved easily. Lead-dislodgement occurred in one out of 16 leads within the first month.
Conclusions: Subxiphoid VAPS is a safe and useful minimal-invasive approach for lead implantation when using a standardized protocol and specific instrumentation. Reoperation from the same approach is feasible, if the identical pericardial entry point is avoided. Current and future development of instrumentation can and will extend safety and possible applications. We, therefore, initiated the human pilot study starting spring 2014.
CMP13 Eighteen-Months Follow-up after Thoracoscopic Isolated Ablation of Lone Atrial Fibrillation using an Epicardial, Beating-Heart Bipolar Ablation Device
Giuseppe Nasso1, Flavio Fiore1, Vito Romano1, Giuseppe Visicchio 1, Giuseppe Greco1, Franco Massari2, Francesco Bartolomucci3, Khalil Fattouch4, Graziano Riccioni1, Giuseppe Speziale1, 1Anthea Hospital, GVM Hospitals of Care and Research, Bari, Italy, 2Division of Cardiology, Altamura Hospital, Altamura, Italy, 3A Division of Cardiology, “L. Bonomo” Hospital, Andria, Italy, 4Division of Cardiac Surgery, Palermo University Hospital, Palermo, Italy.
Objective: The minimally invasive ablation via right minithoracotomy is an emerging option for patients with refractory isolated atrial fibrillation. Despite encouraging clinical results, such epicardial, beating-heart strategy is limited by the heat sink effect from circulating blood at the endocardial surface. A novel device has been developed to perform bipolar and monopolar epicardial ablation on the beating heart. Herein, we describe the average 18.1±7 month clinical follow-up in a single-center experience.
Methods: This device is designed for off-pump epicardial ablation via right minithoracotomy or via ports by creation of a circular ‘box’ lesion around the four pulmonary vein orifices. Suction is applied in order to create a fold of the left atrial myocardium within the probe, and radiofrequency energy is thus delivered from both sides of the myocardial fold. As a result, the endocardial surface is drawn out of the cooling blood flow and a bipolar ablation is achieved. Since early 2012, such strategy was employed through videothoracoscopy in 21 patients. Follow-up consisted of 72-hour ECG Holter monitoring on a monthly basis.
Results: The procedure could be completed uneventfully in all cases, and all patients could be extubated within the 12th postoperative hour. The conduction block was verified routinely by temporary pacing of the left atrial dome, which revealed complete exit block in all instances. We recorded no cases of major or minor postoperative morbidity. The rate of discharge from the hospital in stable sinus rhythm was 95.3% (20 patients). At the latest available follow-up, 20 patients (90.5%) were in stable sinus rhythm and anticoagulant therapy had been withdrawn in 12 (57.1%). No thromboembolic events were recorded.
Conclusions: This mid-term experience suggests that the minimally invasive epicardial, beating-heart ablation of isolated atrial fibrillation is safe and feasible using the novel bipolar device. The heat sink effect can be minimized and the achievement of a transmural lesion is facilitated. Follow-up results may be superior than obtained with established, first-generation thoracoscopic devices (which did not allow bipolar ablation). Formal comparison studies are warranted.
CMP14 Compare Bipolar Radiofrequency and Cryo Ablation Technique during Minimally Invasive Mitral Valve Surgery
Alexander A. Bogachev-Prokophiev, Sergey Zheleznev, Alexey Pivkin, Alexander Afanasyev, Igor Demin, Alexander M. Karaskov. State Research Institute Circulation Pathology, Novosibirsk, Russian Federation.
Objective: In most cases for concomitant treatment atrial fibrillation (AF) during minimally invasive mitral surgery used endocardial cryoablation [Mohr F., 2011] or monopolar radiofrequency (RF) [Jeanmart H., 2006; Krakor R., 2011]. Bipolar RF is to date the most effective way to perform transmural atrial scars for the surgical ablation of AF during open-heart surgery [Gillinov M., 2002; Benussi S., 2005].
Methods: From October, 2011, to November, 2012, we have operated on 53 patients with mitral valve lesion and AF. In 21 (39.6%) patients was performed RF ablation Isolator Synergy Access (AtriCure, Inc.) and in 32 (60.4%) cases cryo lesion CryoIce (AtriCure, Inc.). Mean age was 53.5±6.8 years. The pattern lesion was left atrial ablation in both groups: box-lesion + mitral line + line to left atrial appendage (LAA). The mitral procedure is carried out as usual and LAA appendage sewn from inside.
Results: Mean operation and mean ablation time were 302±58 and 185±47 min (p=0.001) 21.4±5.5 and 58.7±35.2 min (p=0.001) for RF and cryo groups, respectively. There was no hospital mortality or major complications occurred for the mitral procedure. Conversion to sternotomy was in one case in cryo group (bleeding from LAA) (p=0.091). All patients were AF-free at discharge. In 2 (9.5%) cases in RF group and 1 (3.1%) patient in cryo group required pacemaker implantation, owing to sinus node dysfunction (p=0.034). Freedom from AF at 12 month follow-up was 85.7% and 89.1% in RF and cryo groups, respectively (p=0.103).
Conclusions: Concomitant RF and cryo ablation during minimally invasive mitral valve surgery have comparable efficacy. However, RF ablation procedure is technically more difficult to perform and requires more operation time.
CMP15 Early Results of a Novel Versapolar Temperature Controlled Radiofrequency Device for Epicardial, Totally Endoscopic Surgical Atrial Fibrillation Treatment in Patients with Persistent Atrial Fibrillation
Ralf Krakor1, Gianluigi Bisleri2, Pavol Kopriva1, Antonio Curnis2, Hanno Klemm3, Claudio Muneretto21Clinic for Cardiac Surgery at Klinikum Dortmund gGmbH, Dortmund, Germany, 2Division of Cardiac Surgery, University of Brescia, Brescia, Italy, 3Clinic for Cardiology at Klinikum Dortmund gGmbH, Dortmund, Germany.
Objective: Catheter ablation procedures have low effectiveness in isolated persistent and long standing (LS) persistent atrial fibrillation (AF). We analyzed the preliminary results of epicardial, totally endoscopic ablation using a novel Versapolar radiofrequency (RF) ablation device.
Methods: In two heart centers between May, 2012, and October, 2013, 32 patients (pts) (persistent AF: 14 pts; LS persistent: 18 pts) underwent an endoscopic epicardial ablation procedure to create a box lesion set around all pulmonary veins with a radiofrequency device integrating both unipolar and bipolar ablation capabilities. If AF was detected at 3 months after the surgical ablation, a catheter-based procedure was performed. At discharge (32 pts), 3 (30 pts), 6 (20 pts), 12 (14 pts), and 18 months (5 pts) after surgical ablation follow-up (FU) examinations including a quality of life (QoL) assessment were performed.
Results: There were no intra- and post-procedural complications or deaths. Postoperatively, at discharge, 3, 6, 12, and 18 months, freedom from AF was 96.6%, 96.6%, 90.0%, 100.0%, 100.0%, and 100.0% respectively. An additional catheter touch-up was required in only 2 patients. QoL assessments showed a significant post-procedure improvement of physical function, emotional well feeling, social functioning, and general health and a significant decrease in emotional problems and energy fatigue. At 1 year postoperatively, the use of warfarin was significantly decreased compared to the preoperative period (pre=81.3% vs. 12 month FU=28.6%p<0.001) as well as the use of Amiodarone compared to the 3 months follow-up period (3 month FU=80% vs. 12 month FU=21.4%p<0.001). The left atrial antero-posterior diameter decreased significantly over 12 months postoperatively (pre=48.8±3.6 mm vs. 12 month FU=44.8±1.7 mmp<0.01).
Conclusions: The use of this novel Versapolar ablation device was safe and effective in restoring and maintaining sinus rhythm in pts with persistent and LS persistent AF. The integration of unipolar and bipolar RF energy enabled an effective epicardial box lesion set to be delivered via a totally endoscopic approach.
C13 Ablation in Selective Patients with Long-Standing Persistent Atrial Fibrillation: Medium-Term Results of the Dallas Lesion Set
Jiangang Wang, Jie Han, Yan Li, Xu Meng Beijing, Anzhen Hospital, Capital Medical University, Beijing, China.
Objective: The aim of the study was to investigate the efficacy and safety of the Dallas lesion set, which mimics the Cox-maze III left atrial (LA) lesions, for long-standing persistent atrial fibrillation (LSPAF).
Methods: Over a 4-year period, 103 LSPAF patients were treated with the Dallas lesion set (Figs. 1A, B, C, D). Linear lesions were created at the roofline, at the anterior line, and between the roofline and left atrial appendage (LAA). All patients underwent ganglionated plexi ablation and LAA excision as well as pulmonary vein isolation. Follow-up at 6, 12 and 24 months was performed by 48-hour Holter recordings and real-time 3-dimensional echocardiography.
Results: At the 24-month follow-up, 83 of 103 (80.6%) patients were free of any atrial arrhythmia lasting >30 seconds, with 77 patients (74.8%) off of antiarrhythmic drugs. At 3.1 ± 0.7 years, 74 of 103 patients (71.8%) were in sinus rhythm, with 71 patients (68.9%) off of antiarrhythmic drugs. The optimal cutoff value of LA dimension to discriminate atrial arrhythmia recurrence was 55 mm (ROC curve analysis), and Kaplan-Meier analysis showed that patients with an LA dimension <55 mm had less recurrence during follow-up (log-rank testP=0.015). After 6 months, a significant reduction in LA volume and improvement in LA function was noted in patients without recurrence (P<0.05). In contrast, patients with recurrence showed no improvement in LA volume or function.
Conclusions: The Dallas lesion set is an effective treatment in patients with LSPAF. It resulted in significant improvement in LA volume and function after restoration of sinus rhythm.
C14 Totally Thoracoscopic Ablation with Autonomic Ganglia Ablation for Persistent and Long-Standing Persistent Atrial Fibrillation: Mid-term Results
FIGURE C13-1. A, Rig...Image Tools
TABLE C13-1 LA Volum...Image Tools
Anna Witkowska, Krzysztof Jaworski, Radoslaw Smoczyński, Bartlomiej Szafron, Dominik Drobinski, Monika Niewinska, Malgorzata Machaj, Wojciech Sarnowski, Zygmunt Kalicinski, Jaroslaw Swistowski, Dariusz Kosior, Piotr Suwalski. Central Clinical Hospital of the Ministry of Interior in Warsaw, Warsaw, Poland.
Objective: Atrial fibrillation (AF) became a growing problem because of its increasing prevalence, morbidity and economic costs. Pharmacological treatment has poor long-term results and catheter ablation is effective only in selected groups of patients. Here we describe mid-term results of totally thoracoscopic ablation and autonomic ganglia ablation for persistent and long-standing persistent AF.
Methods: 33 patients (21 men, 12 women) admitted to our department between November, 2011, and December, 2013, with persistent and long-standing persistent AF underwent totally thoracoscopic ablation of arrhythmia with left atrial appendage (LAA) stapling. Mean age, time of duration of AF, EuroSCORE II, CHA2DS2-VASc score, NT-proBNP level, left atrial dimension and LVEF were 60 (±9.5) years, 89 (±76) months, 0.96 (±0.59)%, 1.9 (±1.3), 388.6(±472)pg/ml, 44(±6.9)mm and LVEF 58(±9)%, respectively. One patient (3%) underwent prior stroke. All patients underwent transesophageal echocardiography to rule out thrombus in LAA. Ablation was performed with AtriCure (Cincinnati, OH USA) system including bipolar RF pulmonary vein isolation and pattern of connecting lines on the left atrium and trigonal line to the non-coronary sinus. Mapping and epicardial autonomic ganglia ablation was performed. LAA exclusion was performed using Tri-Staple (Mansfield, OH USA) stapler. In all patients bidirectional block across ablation lines was performed. In the perioperative period patients were under continuous rhythm monitoring. 3, 6 and 12 month follow-up using 48-hour ECG-Holter and echocardiography was performed in all patients.
Results: No mortality was observed. 91% patients were in sinus rhythm on admission to intensive care unit and 96% on discharge from hospital. One early patient required sternotomy for bleeding from left atrium without further morbidity. 39% of patients required cardioversion in perioperative period due to AF or atrial flutter. In 6- and 12-month follow-up 85% and 89% of patients remain in stable sinus rhythm, respectively. No incidence of stroke or TIA was noticed. Good atrial transport function and anatomical results of LAA exclusion in echocardiography were observed.
Conclusions: In our experience, totally thoracoscopic ablation with autonomic ganglia ablation for persistent and long-standing persistent AF is feasible and gives good midterm results of maintenance of sinus rhythm and atrial transport function after operation. Further studies in this group of patients are needed.
C15 Profound Cardiac Autonomic Derangement Together With Altered Ventricular Repolarization Paves the Way to Postoperative Atrial Fibrillation
Jurij M. Kališnik1, Eva Hrovat1, Alenka Hrastovec1, Viktor Avbelj2, Borut Geršak1, 1University Medical Center, Ljubljana, Slovenia, 2Josef Stefan Institute, Ljubljana, Slovenia.
Objective: Postoperative atrial fibrillation (AF) represents the most frequent complication after heart surgery using cardiopulmonary bypass (CPB) increasing mortality, morbidity and cost. Despite efforts to identify mechanisms and preventive measures, the results remain suboptimal. It has been shown, that cardiac autonomic derangement plays a significant role in genesis of AF and that it might also be promoted by altered repolarization. Thus, the aim of our study was to determine the levels of cardiac autonomic modulation and repolarization properties in patients that develop AF after heart operations as opposed to those that remain in sinus rhythm.
Methods: 90 consecutive patients scheduled for cardiac surgery with CPB were enrolled in our study prospectively. 9 did not meet inclusion criteria, 2 died in postoperative course, so 79 represented the final sample. High-resolution 20-minute ECG recordings were obtained one day before surgery to determine P, PR, QT and corrected QT (QTc) intervals as well as linear (Time and Frequency domain) and nonlinear HRV parameters (Fractal Dimension, Detrended Fluctuation Analysis (DFA) and Multifractality). QTc interval was calculated using Bazett’s and Hodges correction formula. Statistical analyses were performed with Student t testp value <0.05 was considered significant.
Results: 29 patients developed AF after operation (AF group) and 50 did not (nonAF group). The two groups were similar regarding demographics, surgery type, preoperative and operative characteristics, except for older patients in AF group (74.0±7.7 vs. 69.8±9.4 yrs; p=0.04). QT and QTc intervals (Bazett’s and Hodges correction) were longer in AF group (442.00±44.13 vs. 422.26±28.17 ms; p=0.02, 454.90±49.65 vs. 438.07±28.46 ms; p=0.06 and 448.64±42.77 vs. 430.87±23.51 ms; p=0.02, respectively). Among nonlinear parameters DFA parameter α2 was lower in AF group (0.81±0.21 vs. 0.91±0.20; p=0.03).
Conclusions: Patients, who developed AF after cardiac surgery with CPB, were found to have severe cardiac autonomic derangement already preoperatively. Our study identifies additional marker α2 to differentiate AF from non AF group. We demonstrate for the first time that prolonged QT and QTc intervals are associated with increased risk for postoperative AF.
C16 Pericardioscopic Treatment of Atrial Fibrillation in Patients Previously Undergoing Cardiac Surgery
Andy C. Kiser, Anil Gehi, Paul Mounsey. University of North Carolina, Chapel Hill, NC USA.
Objective: The surgical management of complex atrial fibrillation (AF) in patients that have previously undergone cardiac surgery is difficult; often necessitating a redo, open procedure. Pericardioscopic access to the hostile pericardium can be successfully and safely achieved enabling epicardial ablation of the posterior left atrium which, when performed in simultaneous collaboration with electrophysiology (EP), enables a less invasive surgical option.
Methods: Eight patients with previous cardiac surgery with symptomatic persistent (6) or long-standing persistent (2) AF underwent port-access pericardioscopic unipolar radiofrequency ablation of their posterior left atrium in a hybrid electrophysiology laboratory. Immediately following epicardial ablation, endocardial mapping and ablation was performed to complete antral pulmonary vein isolation and mitral isthmus ablation. Additional complex fractional atrial electrogram ablation, superior vena cava ablation, and cavotricuspid isthmus ablation was left to the discretion of the electrophysiologist. Follow-up was completed with continuously recording implanted monitors (Reveal) or pacemakers.
Results: Seven patients underwent successful completion of the procedure. The average AF duration was 6.2 years. The average left atrial size was 5 cm. All had failed at least one (range 1-4) electrical cardioversion and 3 of 7 patients had failed previous catheter ablations. The average surgical and catheter ablation times were 73 and 222 minutes, respectively. All patients had electrical entry and exit block of the pulmonary veins and electrically isolated posterior left atrium. The average ICU duration was 29.6 hours and average length of stay was 4 days. At an average follow-up of 210 days, all patients had 0% AF burden but remained on antiarrhythmic medications. There were no perioperative or postoperative bleeding, strokes, readmissions, or deaths except one patient that required transfusion for a large groin hematoma. Transdiaphragmatic access to the pericardium was unsuccessful in one patient so the procedure was completed with endocardial catheter ablation alone.
Conclusions: Patients that have had previous cardiac surgery can safely undergo surgical epicardial ablation of the posterior left atrium which, when combined with a simultaneous endocardial ablation procedure, offers potentially improved outcomes but warrant longer term follow-up.
C17 Augmented Reality System for Ultrasound Guidance of Transcatheter Aortic Valve Implantation
Maria E. Currie1, A. Jonathan McLeod2, John T. Moore3, Rajni Patel4, Bob Kiaii1, Michael W. A. Chu1 Terry M. Peters3, 1London Health Sciences Centre, London, ON Canada, 2Western University, London, ON Canada, 3Robarts Research Institute, London, ON Canada, 4Canadian Surgical Technologies & Advanced Robotics, London, ON Canada.
Objective: Transcatheter aortic valve implantation (TAVI) relies on fluoroscopy and nephrotoxic contrast medium for valve deployment. We propose an alternative guidance system using augmented reality and real-time transesophageal echocardiography (TEE) to visualize the location of the tracked valve stent and intraoperatively defined cardiac anatomy. The purpose of this study was to evaluate the targeting accuracy of transapical TAVI deployment using this augmented reality imaging platform in a model of the aortic root.
Methods: Magnetic tracking sensors were integrated into the TAVI catheter and TEE probe, allowing these tools to be displayed in an augmented reality environment (Fig. C17-1). The TAVI valve was deployed five times at a specified depth using a transapical approach. Once deployed, the difference between the intended depth of deployment and the operator’s depth of deployment as measured by the guidance system was recorded as the deployment error. The actual depth of deployment from the aortic valve annulus was measured using calipers. Finally, the difference between the actual depth of deployment and the depth recorded by the guidance system was also reported.
FIGURE C17-1. Augmen...Image Tools
Results: The deployment errors as measured by the guidance system ranged from -2.7 mm to 2.2 mm with a mean absolute value of 1.6 mm and standard deviation (SD) 1.0 mm. This error reflects the motion of the balloon catheter as the valve stent is deployed. The actual depth of deployment deviated from the target depth of 8 mm by -4.2 mm to 1.6 mm with a mean absolute value of 1.7 mm (SD 1.5 mm). Finally, the difference between the actual depth of deployment and the depth recorded by the guidance system ranged from 0.5 mm to 1.5 mm with a mean of 1.0 mm and (SD 0.4 mm).
Conclusions: This study presents the feasibility of an image guidance system for TAVI placement to visualize both the TAVI stent and the critical aortic anatomy without exposure to contrast medium and ionizing radiation. The phantom and ex vivo studies indicate that clinically acceptable targeting errors on the order of 1.5 mm are achievable.
C18 Beating Ball in a Box: A Low Cost Multifunctional Device for OPCAB Training
Hassina Baraki, Shunsuke Saito, George Kensah, Julia Dahlmann, Bernhard Fleischer, Patrick Zardo, Ingo Kutschka. Otto-von-Guericke University Magdeburg, Magdeburg, Germany.
Objective: Simulation provides the opportunity to improve technical skills outside the operating room. Our aim was to build a simple, cost-effective, multi-purpose device for training and education in off-pump coronary artery bypass surgery (OPCAB).
Methods: The device is made of an aluminium box (40 cm x 25 cm x 25 cm) with an open top side. Inside the box we mounted a rubber ball with a diameter of 15 cm, which is connected to an electrically powered air pump (ventilator). The rubber ball can be inflated rhythmically by the ventilator, simulating a beating heart. Displaced volume (stroke volume) and frequency of the pulsatile inflation (40-120 bpm) can be changed to advance training conditions. Furthermore, two accessory box walls can be moved towards the ball, which allows for a gradual reduction of the free moving space of the surgeon. Mechanical stabilizers (e.g., used disposable devices, free of charge) can be mounted on special rails at the upper rim of the box. Disposable silicon surgical tubes in several sizes (1.5 - 3.0 mm) are used as vessel conduits. They can be mounted on the rubber ball in various locations using tape stripes.
Results: This small and portable simulator allows for education and training of the whole range of modern coronary surgery. It provides a realistic simulation for OPCAB and minimally invasive coronary surgery, including several levels of difficulty by modification of the beating frequency, beating volume, free moving space and vessel size. All instruments and suture materials can be placed inside the small box for easy storage and transportation. Due to the simple design of the device, a reasonable pricing can be achieved.
Conclusions: This simulator represents a new innovative tool for training and teaching of OPCAB surgery in a realistic setting. Its manufacturing is simple and cost effective. It may contribute to improve training programs and learning curves.
CMP16 Mitral Valved Stent Implantation: Transesophageal Echocardiographic Guidance for Asymmetrically Shaped Stent Designs
Katharina Huenges, Saskia Pokorny, Telse Bähr, Matthias Gegenwart, Justus Gross, Jochen Cremer, Georg Lutter, Department of Cardiovascular Surgery, University Hospital Schleswig-Holstein, Campus Kiel, Kiel, Germany.
Objective: Different valved stent designs have been presented for off-pump implantation into the mitral valve. In this study, our experiences with 2D and real-time 3D transesophageal echocardiographic (TEE) guidance and evaluation of symmetrical and irregularly shaped stents are presented.
FIGURE CMP16-1. TEE ...Image Tools
Methods: Two mitral valved stent prototypes were developed, comprised of a circular atrial element, a ventricular body accommodating a bioprosthetic heart valve and an apical fixation system. The first design AP (n=10) was symmetrically shaped. In the second design SUB (n=10), asymmetrically distributed fixation elements were included at sub-annular level. The stents were implanted into the native mitral annulus of pigs (50±2kg) via transapical approach in the beating heart under sole TEE guidance. Echocardiographic and hemodynamic parameters were assessed following a standardized protocol before (n=20) and 1 h after implantation (n=18).
Results: Two animals were excluded from the study due to ventricular fibrillation prior to stent deployment. 3D TEE provided dependable spatial visualization of the left heart, mitral apparatus, delivery system and valved stent (Fig. CMP16-1). It was an adequate method for correct positioning of the stent with symmetrical design. Disadvantage of this technique were the strong artefacts caused by the metal frame, shadowing the structures beyond the stent. This showed to be particularly challenging during positioning of the asymmetrically shaped stents. Rotational orientation was correct in seven of eight cases. However, visibility of the asymmetrically distributed fixation elements was small and the judgment of the stent orientation, therefore, time consuming.
Conclusions: 3D TEE provides accurate views and allowed assessment of regurgitations and 3D imaging of the stent. Drawback is the sound cancellation beyond the valved stent. This particularly limits the evaluation of the correct stent orientation of asymmetrically shaped stents. If the landmarks are small, it might be beneficial to perform additional fluoroscopy for judgment of the stent orientation. Choosing the optimal imaging technique or combination optimizes the results, not solely in experimental developments. Each prototype may require different imaging techniques as the challenges depend on individual design features.
CMP17 Role of Triple Fusion Multimodality Imaging in Alternative Transcatheter Hybrid Procedures
Luigi Pirelli, Chad A. Kliger, Sean R. Wilson, Carlos E. Ruiz, Gregory P. Fontana. Lenox Hill Hospital, New York, NY USA.
Objective: Multimodality imaging techniques play a key role in planning and guiding alternative transcatheter hybrid procedures. The triple fusion of computed tomography (CT) and 2-D/3-D echocardiography with live fluoroscopy represents a novel imaging modality that enables better planning and conduct of hybrid cardiac procedures. Implementation and improvement of delivery technologies, devices and imaging modalities have rendered these interventions more accurate, precise and safe. The direct transaortic approach is an option for aortic valve deployment when extensive calcification or tortuosity involves the ileo-femoral vessels, or a transapical approach is not a safe alternative. Our objective was to assess the utility of fusion imaging technology for TAVR via the direct aortic approach.
Methods: We studied a series of 11 patients (mean age 84.8±5.3 years) who underwent direct transaortic valve implantation using fusion imaging technology. The approach used to access the ascending aorta was an upper mini-manubriotomy. Self expandable valves were used in all cases. Preacquired CT was performed in all patients and fusion software technology was utilized to merge CTA and fluoroscopy. The merge of CT, echocardiography and fluoroscopy was utilized to assess the aortic wall and determine the optimal and safest access point for device delivery. This imaging merging technology also allowed defining the optimal angles and planes for valve deployment on the aortic annulus and the distance between the point of entry of the sheath in the ascending aorta and the valvular plane.
Results: There were no intraoperative or hospital mortalities. The calcium score of the ascending aorta was 6584±4240. Double aortic puncture was performed in 4 patients (37%) and transfemoral introduction of the pigtail in the remaining 7. The access distance to the valve and center line angulation was optimal for deployment in all cases. None of the patients experienced stroke or embolic event. Fluoroscopy time was 12.8±2.9 minutes.
Conclusions: Triple fusion multimodality imaging technique is helpful in planning and executing alternative access hybrid cardiac procedures. It limits radiation time to the patients and provides an accurate mapping and guidance of the ascending aorta and aortic annulus, avoiding atheromatous and calcified plaques.
CV2 Intraoperative Detection of Coronary Stenosis in the Lack of Preoperative Coronary Angiography: The Role of High-Resolution Epicardial Ultrasonography
Gabriele Di Giammarco1, Daniele Marinelli2, Massimiliano Foschi2, Donato Micucci2, Sabina M. A. Diso2 Carlo Canosa2. 1University G. D’Annunzio, Chieti, Italy, 2University, Chieti, Italy.
Objective: The prevalence of coronary atherosclerosis in candidates to valvular surgery range from 35.6% to 50%. Intra-operative high-resolution epicardial ultrasonography (HR-ECUS) is a validated diagnostic method. We report on three patients candidate to non-coronary surgery whose comorbidity or clinical status represented a contraindication to coronary angiography. The use of HR-ECUS facilitated critical LAD stenosis detection intraoperatively.
Methods: Patient 1 83-year-old female with diagnosis of severe aortic stenosis symptomatic for dyspnea and severe stenosis of the right internal carotid artery. Due to a recent episode of pulmonary edema and acute kidney injury (AKI), she was refused contrast dye injection.
Patient 2 84-year-old female with a recent acute coronary syndrome and a peduncolated mass of 2.7 cm in left atrium impinging in the mitral annulus. A moderate carotid stenosis and moderate chronic renal failure were present. The patient, after pre-syncopal episodes, was emergently led to the operation without coronary angiography.
Patient 3: 67-year-old man was referred for severe aortic regurgitation (AR) due to Staphylococcus Galloliticus infective endocarditis with large vegetation on non-coronary cusp. He was refused for coronary angiography for the high risk of embolism.
Results: In all cases intraoperative HR-ECUS detected severe stenosis of left anterior descending artery (LAD). Patient 1 was submitted to aortic valve replacement, saphenous Vein (SV)-to-LAD CABG and carotid thrombo-endarterectomy. Patient 2 was submitted to left atrial myxoma resection and SV-to-LAD CABG. Patient 3 was submitted to aortic valve replacement and left internal mammary artery-to-LAD CABG. In all three cases transit time flow measurement showed in all cases good functioning grafts. The graft patency was confirmed postoperatively by coronary CT-scan.
Conclusions: To the best of our knowledge, this is the first report of coronary revascularization guided by intraoperative HR-ECUS. In our experience, this method represents a feasible alternative to coronary angiography in selected situations.
CMP18 Advanced CT-Derived Analysis to Optimize Preoperative Surgical Planning in Patients Undergoing Minimally Invasive Cardiac Surgery Procedures
Pasquale Totaro, Alessandro Mazzola. Cardiothoracic Surgery, IRCCS Foundation San Matteo, Pavia, Italy.
Objective: The evolution of imaging technologies and post-processing tools allow a real useful support during surgical operation planning. CT images have become the gold standard for the diagnosis and the evaluation of several cardiothoracic diseases. The introduction of several dedicated software furthermore has enhanced the three-dimensional reconstruction of chest structures allowing a real improvement in preoperative evaluation and surgical planning in patients undergoing cardiac surgery. Here we present our original multidisciplinary approach to optimize preoperative surgical planning.
Methods: Patients undergoing cardiothoracic surgery procedures with a proposed minimally invasive approach undergo synchronized multi-sliced CT scan of the chest with three-dimensional reconstruction. Following a primary discussion between the radiologist and the surgeon the images are uploaded in the general system and the surgeon further analyzed them in cooperation with the engineering department in order to create ad-hoc reconstructions to support the preoperative surgical planning. This is accomplished with the primary identification (Fig. CMP18-1A) of the useful surgical spots (i.e., aortic and atrial cannulation sites, clamp position, site of aortotomy and atriotomy) using free imaging software (e.g., Osirix). The safety and useful of different minimally invasive approaches can be then simulated using computational programs (e.g., Matlab) as shown in Figure CMP18-1B/C.
Results: Application of such technologies and a structure protocol allows obtaining useful information in preoperative surgical planning process. As a result of such combined protocol, we were able preoperatively to either confirm the level of minimally invasive approach (45% pts.), modify the level confirming minimally invasive approach (35% pts.), or even abandon the indication for minimally invasive approach (20%).
FIGURE CMP18-1. A, M...Image Tools
Conclusions: The application of modern technologies and updated software to achieve the optimal mixture between fine diagnostic experiments and real clinical advantages require the multidisciplinary interest and a true cooperation. Current available software allows obtaining an advanced preoperative surgical planning and should be used to optimize the surgeon decision making.
CMP19 An Automated Coaxial Fastener to Secure ePTFE Suture for Mitral Valve Repair and Results from an Innovative Testing Method Demonstrating Its Durability
Angelo J. Martellaro1, Jude S. Sauer1, Candice Y. Lee2, Peter A. Knight2. 1LSI SOLUTIONS, Victor, NY USA, 2University of Rochester Medical Center, Rochester, NY USA.
Objective: While suture and knot integrity is critical to surgical outcome, testing techniques quantifying tensile strength over time are not well established. Better analytics are required for the safe introduction of new technologies to fasten suture. Ergonomic mechanical fasteners that reliably secure ePTFE suture could advance mitral valve repair. This study presents a new automated coaxial titanium fastener technology for mitral chordal replacement and results from an innovative testing method demonstrating its durability.
Methods: Ten hand-operated devices created 120 samples of hollow titanium fasteners crimped around two closed ePTFE suture loops coaxially oriented in opposite directions. Each fastener secured together one CV4 suture loop attached to a spring on a stationary lower plate and one CV5 suture loop attached to a mobile upper plate. With both plates submerged in saline, a motorized fixture moved the upper plate up and down to repeatedly cycle suture tension from approximately 0.050 to 0.150 kgf at 80 “beats” per minute. Seven different time intervals were evaluated, from 0 cycles (baseline) to 10,500,000 cycles (3 months) Table CMP19-1. Following completion of each time interval’s tension cycling, suture loops were pulled apart to measure fastener holding strength.
Results: All fasteners demonstrated excellent ePTFE suture holding forces (mean: 0.688±0.104 kgf, range: 0.505 to 0.912 kgf). Over 440,000,000 suture tensioning cycles were conducted for a cumulative cycling time of over 3,835 days. There was no statistically significant difference in average fastener strength between a shorter duration group (baseline, 1, 3 and 7 days) compared to a longer duration group (1, 2 and 3 month group; 0.680 vs. 0.696 kgfp = 0.41).
Conclusions: This new approach to testing cardiac sutures under simulated physiologic conditions holds promise for comparative studies. This research demonstrated that titanium coaxial fasteners used to secure ePTFE suture retain supra-physiologic strength for at least 3 months without any apparent degradation over time. These results encourage further exploration of coaxial titanium fasteners in surgical therapy for mitral valve disease.
CMP20 The Hemodynamic and Respiratory Effects of “Spacemaker” Facilitated Thoracoscopy vs. Conventional Facilitated Thoracoscopy in a Porcine Model
Pieter W. Lozekoot1, Paul B. Kwant1, Paul F. Gründeman2, Jos G. Maessen1. 1Maastricht University Medical Center, Maastricht, Netherlands, 2University Medical Center Utrecht, Utrecht, Netherlands.
Objective: Minimally invasive cardiothoracic surgery requires carbon dioxide (CO2) -insufflation and/or single lung ventilation (SLV) to gain surgical exposure. These techniques may coincide with a firm drop in hemodynamic and respiratory parameters. We invented an inflatable lung retractor called “Spacemaker”, which should facilitate thoracoscopy without the homeostatic sequelae associated with conventional techniques. We present an experimental study evaluating the physiological effects of this novel tool in comparison with the effects of conventional techniques.
Methods: Fourteen anesthetized pigs (90-100 kg) were allocated to either “Spacemaker” facilitated left-sided thoracoscopy (n=7) or a sequence of thoracoscopy (control n=7) with two lung ventilation (TLV) or SLV with or without CO2-insufflation up to 12 mmHg. “Spacemaker” introduction was performed through a soft-tissue port in the fifth intercostal space, gently pushing the lung dorsally, creating similar surgical exposure as observed with conventional techniques. Control group animals received a 10 mm trocar in the fifth intercostal space for CO2-insufflation, while SLV was achieved through a bronchial blocker in the left main bronchus. During experiments hemodynamic and ventilatory functions were monitored.
TABLE CMP19-1 Coaxia...Image Tools
Results: SLV did not significantly alter stroke volume (SV), mean arterial pressure (MAP), paO2 or paCO2. Additional intrathoracic CO2-insufflation diminished SV. During TLV, similar effects were observed, but did not reach significance at 4 mmHg CO2-insufflation. “Spacemaker” positioning initially led to a decrease in SV which almost recovered at follow-up. These observations did only translate into a decrease in MAP’s during CO2-insufflation both in SLV as also in TLV, but not in the “Spacemaker” group. During insufflations of various pressures of CO2, paO2 decreases were observed in both SLV as TLV, but not in the “Spacemaker” group. The “Spacemaker” group showed a decrease of paCO2 after 2 and 3 hours (Fig. CMP20-1).
Conclusions: “Spacemaker” facilitated thoracoscopy, obviating SLV and/or CO2-insufflation, showed an equal decrease in hemodynamic function as observed with current clinical practice (SLV + CO2 8 mmHg). Optimization of the model is expected to further preserve the hemodynamic homeostasis and possibly offer an alternative to conventional techniques.
FIGURE CMP1-1. The h...Image Tools
C19Robotic Mitral Valve Repair: A Single Institutional Series of 853 Procedures
L Wiley Nifong, Hazaim Alwair, Kaushik Mandal, Aseem Srivastava, W. Randolph Chitwood, Jr., East Carolina Heart Institute at East Carolina University, Greenville, NC USA.
Objective: Minimally invasive mitral valve surgery has become the standard of care at many institutions. Moreover, robot-assisted mitral valve repair (RAMV) also has become established in large institutions in the United States. We reviewed our experience of 853 RAMVs over 14.5 years.
Methods: Data variables on all operative cases were collected prospectively and entered into a secure database. We reviewed all RAMVs done at our institution from May, 2000, through November, 2013. Our preoperative assessments as well as patient positioning and robotic set-up were standardized. Variables reviewed included cardiopulmonary bypass (CPB) and cross-clamp times (XC) as well as post-operative outcomes, including successful repair rates and complications.
Results: A total of 853 patients (363 women) underwent RAMV repairs. Previous cardiac surgery had been performed in 35 (4.0%). Mean age was 59.4±13.1 years. Comorbidities included AFib (n=290, 34.0%), hypertension (n=429, 50.3%), CAD (n=112, 13.1%), CHF (n=607, 71.2%), pulmonary hypertension (n=236, 27.7%), prior stroke (n=29, 3.4%), and endocarditis (n=31, 3.6%). CPB and XC times were 159.3±44.0 and 113.9±31.5 minutes, respectively. One or more concomitant procedures performed included PFO closure (n=114, 13.4%), cryomaze (n=223, 26.1%), left atrial appendage suture closure (n=218, 25.6%), and tricuspid valve repair/replacement (n=11, 1.3%). Repairs included leaflet resections (LR) with or without a chordal procedure (CP) (n=402, 47.1%), CP only (n=102, 12.0%), LR with sliding valvuloplasty (n=112, 13.1%), annuloplasty only (n=103, 12.1%) and other (n=134, 15.7%). All patients had a band annuloplasty. Post-op TEE MR grade was 818 (95.9%) none or trivial, 25 (2.9%) mild, seven (0.8%) moderate and none with severe. The 30-day mortality was 1.3% (n=11). There were no aortic dissections or peripheral vascular complications. Complications included eight strokes (0.9%), seven peri-operative myocardial infarctions (0.8%), and 26 re-explorations for bleeding (3.0%). The mean length of hospital stay was 5.4 days. A total of 24 patients (2.8%) required a later MV reoperation.
Conclusions: RAMV repair alone or in combination with other cardiac procedures is safe and reproducible with excellent results. Case volume, surgeon repair expertise, and team synergy are critical in maintaining proficiency and to achieve optimal robotic mitral valve repair outcomes.
C20 Repair of Barlow Mitral Valves through the Minimally Invasive Route: Continuing Noninferiority at Five-Years in a Randomized Study vs. Median Sternotomy
Giuseppe Nasso1, Flavio Fiore1, Vito Romano1, Giuseppe Visicchio 1, Emanuele Greco1, Franco Massari2, Francesco Bartolomucci3, Khalil Fattouch4, Graziano Riccioni1, Giuseppe Speziale1. 1Division of Cardiac Surgery, GVM Care & Research, Bari, Italy, 2Division of Cardiology, Altamura Hospital, Altamura, Italy, 3Division of Cardiology, “L. Bonomo” Hospital, Andria, Italy, 4Division of Cardiac Surgery, Palermo University Hospital, Palermo, Italy.
Objective: Barlow disease of the mitral valve (bileaflet prolapse with diffuse floppy tissue and annular dilatation) is a complex lesion entailing major surgical challenges to achieve adequate repair. In previous studies, the surgical approach to the mitral valve (right minithoracotomy or median sternotomy) has been reported to have limited influence over the reliability of repair. We report the five-year follow-up of a randomized study comparing alternative surgical accesses for repair of complex mitral lesion (Barlow).
Methods: A randomized study of mitral repair for Barlow disease (bileaflet prolapse) via the minimally invasive access (MI group) vs. median sternotomy (MS group), we achieved an average 5±1.2 year follow-up. Artificial chordal implantation was used for both leaflets instead of leaflet resection. Follow-up consisted of echocardiography, physical exam and quality-of-life assessment (SF-36 questionnaire) at 6-month intervals.
Results: Groups included 105 (MI) and 104 (MS) patients. Operative time was significantly longer in the MI group (p=0.03), but there was no meaningful difference in cardiopulmonary bypass time (p=0.4). Mitral repair was successfully performed in 104 and 105 cases (MS and MI groups, respectively, 99% both). Mechanical ventilation time, intensive care unit and hospital stay were shorter in the MI group (p=0.002p=0.009 and p=0.004, respectively). At the end of the follow-up, 11 patients in the MS group (10.6%) and 10 in the MI group (9.5%) displayed residual mild mitral regurgitation, while moderate/severe regurgitation and heart failure occurred in 4 patients in the MS group (3.8%) vs. 5 cases in the MI group (4.8%p=0.7). The rate of mitral reoperation was 3.8% in both groups. The overall mortality was 2.9% in both groups. Survival free from any adverse mitral event (including moderate/severe regurgitation and mitral reoperation) was comparable among groups (p=0.84 Kaplan-Meier analysis). Analysis of SF-36 scores at the latest available follow-up evidenced comparable average outcomes for all SF-36 domains.
Conclusions: In this continuing follow-up of a randomized study over the surgical approach to repair the Barlow mitral valve, the outcomes of repair are independent on which surgical approach is employed (minithoracotomy vs. full sternotomy). Quality-of-life outcomes are comparable at 5 years.
C21 Right-Sided Minimally Invasive Mitral Valve Surgery on the Fibrillating Heart: A Safe and Effective Strategy
Jens Garbade, Piroze Davierwala, Joerg Seeburger, Bettina Pfannmueller, Martin Misfeld, Friedrich-Wilhelm Mohr, Michael A. Borger. Herzzentrum Leipzig, Leipzig, Germany.
Objective: Minimally invasive mitral valve surgery (MiniMV) after previous cardiac procedures or in patients with porcelain aorta is a challenging clinical scenario. We reviewed our experience in patients operated on with a non-aortic clamping, fibrillating heart technique during MiniMV.
Methods: Between 1999 and 2011, a total of 3500 patients underwent MiniMV at our institution. Of these, 190 (5.4%) were operated without clamping of the aorta and on the fibrillating heart. The majority of patients had a history of previous cardiac surgery: aortocoronary bypass grafting, n=85; isolated valve procedure, n=60; or combined interventions, n=30. Some patients had a severely calcified aorta or severe adhesions because of previous irradiation therapy (n=15). The indication for surgery was severe symptomatic MV regurgitation in all patients. Mean age of patients was 65.8±10.8 years and 125 were male. The mean ejection fraction was 48±14% and the mean EuroSCORE predicted risk of mortality was 18.9±14.6%.
Results: MV repair, including repeat repair, was accomplished in 57% of patients (n=108) and MV replacement was required in 43% (n=82). Duration of CPB was 144±59 min and fibrillating time was 67±26 min. Primary MV repair included the implantation of an annuloplasty ring in all patients (complete and partial rings were implanted in 85 patients). Concomitant procedures consisted of tricuspid valve repair in 17, atrial fibrillation ablation in 41, and ASD closure in 2 patients. Thirty-day mortality was 6.8% (n=13). The over-all rate of stroke or TIA was 3.7% (n=7). Conversion to full sternotomy was necessary in 4 patients (2.1%), while 17 patients (9%) required reexploration for bleeding. Early echocardiographic follow-up revealed adequate MV function in the vast majority of patients. MV-related re-intervention was required in 12 patients, while one additional patient underwent heart transplantation. Ten-year freedom from MV reintervention rate was 93%.
Conclusions: MiniMV without aortic clamping and on the fibrillating heart is technically demanding but can be performed successfully, with low rates of peri-procedural complications and good early- and long-term results.
C22 Mitral Valve Regurgitation Due to Bileaflet Prolapse: Physiological Correction through a Totally Video-Guided Approach
Tommaso Hinna Danesi, Giovanni Domenico Cresce, Loris Salvador. Ospedale San Bortolo Vicenza, Vicenza, Italy.
Objective: Mitral valve regurgitation (MVR) due to bileaflet prolapse (BP) is one of the most complex lesions to be treated by reconstructive surgery. In the present study, we report our operative results in the management of BP-MVR using a physiological repair and a minimally invasive totally video-guided approach.
Methods: From January, 2010, to November, 2013, 601 patients underwent totally video-guided port-access cardiac surgery at our Institution. Among them, 506 (84%) received a mitral valve repair. A degenerative pathology underlying a severe mitral regurgitation was the indication for surgery in 409 cases; among them 78 (19%) patients (50 male; mean age 59.4 ± 16.1 years) had a BP-MVR. Fourteen patients (17.8%) were in NYHA functional class III or IV. The technique utilized to repair the MVR was the e-PTFE neo-chordae implantation completed with a posterior annuloplasty using a flexible band. Associated procedures were: tricuspid valvuloplasty in 4 cases (5%), AFib radiofrequency ablation in 14 pts (18%) and a PFO closure in 34 pts (43.5%).
Results: Mean CBP time and x-clamp time were 148±53 and 107±52 min respectively. There was no in-hospital mortality. We had no conversion to conventional sternotomy, reoperation for bleeding and aortic dissection. We achieved the mitral valve repair in all cases. Six patients (7.6%) required an edge-to-edge stitch to avoid systolic anterior motion (SAM) of the anterior MV leaflet. Postoperative complications were: new atrial fibrillation onset in 6 patients (7.6%) and atrio-ventricular block requiring permanent pacing in 2 patients (2.5%). No major neurological events were observed. At discharge postoperative echocardiogram showed mild residual MVR in 2 (2.5%) cases, due to mild SAM without left ventricular outflow obstruction.
Conclusions: Our results showed the effectiveness of the respect-than-resect technique in the treatment of MVR due to BP. The reduction of leaflets remodeling maneuvers is particularly useful with a completely video-guided thoracoscopic MV approach.
CV3 Trans-Apical, Off-Pump Edge-to-Edge Mitral Valve Repair
Richard Daly1, John Zentgraf2, John Seaberg2, Giovanni Speziali 2. 1Mayo Clinic, Rochester, MN USA, 2Neochord, Inc., Eden Prairie, MN USA.
Objective: The edge-to-edge (E-E) technique is a recognized method to treat mitral regurgitation (MR) and is used in both open and minimally invasive approaches. We report laboratory evaluation of an instrument, which was designed to place artificial chordae tendineae (ACT) on the mitral valve (MV), to create an off-pump, minimally invasive E-E repair of the MV.
Methods: ACT were placed on opposing aspects of the anterior and posterior leaflets of the MV in swine, off-pump, through a trans-apical approach using echo guidance. Three knot-tying techniques were evaluated (knots 1, 2, and 3). Acute procedural success (APS) was defined as creation of a double orifice MV by echocardiogram, and good contact of the two leaflets at autopsy. Chronic animals were studied at 3 months.
Results: There were 11 acute studies and 9 chronic studies. Three different knot configurations were evaluated. APS for knots 1, 2 and 3 were (success/total): 1/4, 0/1, and 4/4, respectively. Chronic success for knots 1, 2 and 3 was 1/2, 1/3 and 2/4, respectively. Knot 3 was placed twice in 2 animals with APS 2/2; Figure CV3-1 shows 2 knots each with attached ACT and forceps through the double orifices of the mitral valve.
Conclusions: Placement of the ACT on opposing aspects of the two MV leaflets was straightforward. Evolution of knot techniques led to a knot that reliably created an E-E repair acutely. Chronic outcomes may have been compromised by 100% growth in the animal model. Double knots (Fig. CV3-1) may improve the area of leaflet coaptation and durability. The technique is unique in that it allows the E-E repair to be supported by ACT.
CV4Off-Pump Transapical Mitral Valved Stent Implantation: A Case Video
FIGURE CV3-1. Two ad...Image Tools
Saskia Pokorny1, Katharina Huenges1, Telse Bähr1, Matthias Gegenwart1, Martin Marczynski-Bühlow1, Lucian Lozonschi2, Jochen Cremer1, Georg Lutter1. 1Department of Cardiovascular Surgery, University Hospital Schleswig-Holstein, Campus Kiel, Kiel, Germany, 2Department of Cardiothoracic Surgery, University of Wisconsin, School of Medicine and Public Health, Madison, WI USA.
Objective: Implantation of a valved stent into the beating heart is a novel experimental approach to the treatment of mitral regurgitation. In this video, the transapical implantation technique of a mitral valved stent in the beating heart is presented.
Methods: A self-expanding mitral valved stent was implanted in a pig (46 kg) under general anesthesia following a standardized protocol. The valved stent was comprised of an atrial element, a tubular ventricular body accommodating a bioprosthetic heart valve and an apical fixation system. A lower ministernotomy was performed through a 1.5 inch skin incision, the pericardium was opened and the apex of the heart thereby exposed. Two rows of purse-string sutures were placed on the apex. The valved stent was crimped into the proximal tip of the delivery system. Following apical incision, the delivery system was inserted and advanced to mid-atrial position guided by real-time three-dimensional transesophageal echocardiography (TEE). The stent was deployed in a double-staged procedure and apically fixated after correct positioning. Correct stent position was determined by evaluation of TEE images, pulmonary capillary wedge pressure (PCWP) and mitral annular plane systolic excursion (MAPSE). Hemodynamic stability and stent function were assessed before and one hour after implantation. The thorax was closed; the pig was transferred to the animal facility and followed up after one month.
Results: The stent was successfully implanted showing no paravalvular leakage (PVL). The mean transvalvular gradients of the mitral/aortic valve after implantation and after one month were 2.5mmHg/2.0mmHg and 2.0mmHg/3.3 mmHg, respectively. The E/A ratio was stable. The pig recovered well from surgery and was fit on the post-operative day and was at good health throughout the observation period. One month follow-up showed none to trace PVL, a normal EF (67%), no obstruction of the left ventricular outflow tract, a physiological MAPSE and slightly increased PCWP (post implant: 11mmHg, 1 month: 15mmHg).
Conclusions: The implantation technique of a novel mitral valved stent into the beating heart via transapical approach is presented. TEE guidance, reliable stent stability, minimal gradients and good valvular function were achieved and the pig recovered well from surgery.
CMP21 Cracking the Code: A Routine, Reproducible, and Standardized Anterior Leaflet Augmentation Technique for Type III Mitral Regurgitation Repair Using Bioresorbable Matrix
Mohammed A. Kashem, Thomas Kelley, Vishnu V. Ambur, James McCarthy, Sheela Pai, Yanfu Shao, Grayson Wheatley, Yoshiya Toyoda, T. Sloane Guy. Temple University School of Medicine, Philadelphia, PA USA.
Objective: We recently adopted a simple technique to treat Carpentier Type III mitral insufficiency (MR) using routine anterior leaflet augmentation with CorMatrix Extracellular Matrix (ECM) in robotic mitral valve surgery with good short-term results. The primary goal of our simplified technique is to dramatically improve leaflet coaptation. We believe the ECM also preserves the mobility of the anterior leaflet which is important for leaflet function.
Methods: During December, 2011, to November, 2013, we performed totally endoscopic robotic mitral valve repair in 20 patients. Flexible bands were used in all cases with sizes of 27.9±2.2mm. Our simplified technique involves detachment of the anterior leaflet at its base from commissure to commissure (allowing the native leaflet to fall posteriorly toward the posterior leaflet) and placement of a large ECM patch into the defect. An annuloplasty sizer is used to select a band based on the inter-trigonal distance and is also used as an exact template to fashion the ECM patch.
Results: Mean age was 58.5±3.0 years. EF was 48.6±3.4%. Pre-op regurgitation was severe in all cases. There was no in-hospital mortality. Bypass time was 132±8 minutes and 96±4 minutes cross-clamp time. 2 cases needed blood transfusion and 1 patient needed additional tricuspid repair. Median length of stay was 7±0.7 days. Post-op echocardiography demonstrated a 50±4% EF and all patients were free of MR at the end of surgery on follow-up one month later.
Conclusions: The routine use of this simple technique of anterior leaflet augmentation with ECM for Type III MR produced consistent and excellent short-term results by dramatically improving leaflet coaptation. Having struggled to repair these valves in the past, we feel we have cracked the code on Type III MR.
CMP22 What is the Size of an Annuloplasty Ring Made Circular?
Gry Dahle, Kjell Arne Rein. Rikshospitalet, OUS, Oslo, Norway.
Objective: Mitral regurgitation is the second most frequent valvular disease. The trend is more valve sparing procedures, preferably with the use of annuloplasty rings. The repair may fail and transcatheter valve-in-ring may be an option. Several case reports are available. The semi-rigid rings are oval shaped but will become circular on a rigid valve stent; though will the circular diameter turn out different than the given oval size?
Methods: Bench tests were done for the CE Physio ring 1 (Edwards Lifesciences, Inc., Irvine, CA USA). The different ring sizes were tried on CarboMedics (CM) (CarboMedics Inc., Austin, TX USA) sizers. Then the outer diameters of the CM sizers were measured by calipers. In the end, Edwards SAPIEN XT (Edwards Lifesciences, Inc., Irvine, CA USA) valves were deployed in the Physio rings. All documented by photo and video.
TABLE CMP22-1 Measur...Image Tools
Results: See Table CMP22-1. A Physio ring made circular turns out much smaller than the given size, i.e., a Physio ring 28 fits on a CM sizer 23. The measured outer diameter of a CM sizer is not the same as given for the sizer.
Conclusions: Valve-in-ring is feasible for semi-rigid annuloplasty rings. The given size of an annuloplasty ring is not the same when it is made circular. For the moment, the Edwards SAPIEN XT may be deployed in Physio rings from size (24), 26 to 34.
C23 Safety and Efficacy of Routinely Retrograde Arterial Flow via Femoral Artery during Minimally Invasive Cardiac Surgery
Claudio Muneretto, Laura Giroletti, Alberto Repossini, Gianluigi Bisleri. University of Brescia Medical School, Brescia, Italy.
Objective: Minimally invasive procedures have been gaining popularity during recent years and often imply the use of peripheral sites for CPB cannulation. Nevertheless, there is lack of evidence whether retrograde arterial flow following femoral artery cannulation in elective surgery could lead to an increased risk for iatrogenic complications, such as thromboembolism and retrograde aortic dissection.
Methods: From March, 2000, to October, 2013, 496 consecutive patients underwent minimally invasive cardiac surgical procedures by means of femoral artery cannulation with a Seldinger approach and arterial retrograde CPB flow with a centrifugal pump. Mean age was 58.8±13.9 yrs. while Logistic EuroSCORE was 4.1±1.9. Average values of BMI and BSA were 26±5.56 Kg/m2 and 1.81±0.22 m2 respectively. Peripheral vascular disease (not critical) was present in 29.4% (146/354 pts.). Patients undergoing surgical treatment of aortic dissection and aortic arch procedures were excluded from the data analysis.
Results: Mitral valve surgery was performed in 190 pts. (38.3%), while surgery of the aortic valve/ascending aorta in 229 pts. (46.2%); 11.7% (58 pts.) of cases underwent surgical closure of ASD/PFO. Finally, other procedures (including myxoma removal) were performed in 3.8% of cases (19 pts.). Iatrogenic aortic dissection did not occur in any patient of the current series. Minor strokes or TIAs occurred in 6 patients (1.2%), all of them showing full functioning recovery at 30 days postoperatively. Limb complications, such as ischemia or femoral vessel dissection was 0%, while femoral nerve injuries (local paresthesia) were recorded in 1.8 % (9/496 pts.); inguinal lymphorrhea occurred in 2 pts. (0.4%). Hospital mortality was 0.8% (4 pts.).
Conclusions: Arterial retrograde perfusion with Seldinger cannulation of the femoral artery and centrifugal pump during minimally invasive cardiac surgery is nowadays a safe maneuver and is not associated with an increased risk of iatrogenic aortic dissection or major thromboembolic complications. The routine peripheral arterial cannulation enhances the feasibility of minimally invasive procedures while reducing the drawbacks of central cannulation through limited access.
C24 Retrograde Autologous Priming (RAP) as a Safe and Easy Method to Reduce Hemodilution and Transfusion Requirements during Cardiac Surgery: Comparison between RAP, Standard and Miniaturized Extracorporeal Circulation
Maximilian Halbe, Chris Probst, Armin Welz. University of Bonn, Bonn, Germany.
Objective: In the last decade, there have been some exciting developments in the design of cardiopulmonary bypass (CPB) systems to reduce the adverse clinical effects of the heart-lung machine. Mini-extracorporeal circulation (MECC) is one example that has shown promising clinical results. Also the technique of retrograde autologous priming (RAP) of the CPB circuit has regained interest as an easy method in order to decrease hemodilution. The purpose of our study was to investigate the impact of RAP on the intraoperative hematocrit level and the consequent need for blood transfusion in comparison to standard CPB (SCPB) and a Minimal System (Terumo ROC Safe) in elective coronary artery bypass (CABG) patients operated by a single surgeon.
Methods: Data were retrospectively collected on 3 cohorts of adult CABG patients operated on by a single surgeon. Group RAP (n=30) of patients were operated using the RAP and control groups of patients operated using SCPB standard crystalloid method (n=30) and ROC Safe (n=30). Intra- and postoperative data of the three groups were obtained and analyzed by using SPSS for Windows. A p- value of p<0.05 was considered significant.
Results: There was no significant difference in the demographic data of the three groups. The priming volume was SCPB: 1608±181 ml, RAP: 946±212 ml and ROC Safe: 567±98 ml (p<0.001). There were significant differences in hemodilution (p<0.05), intraoperative transfusion requirements (p<0,001), intraoperative lactate levels (p<0.05), urinary excretion (p<0.05) and postoperative transfusion requirements (p<0.05). There were no differences between the 3 groups in the incidence of several other postoperative complications.
Conclusions: In conclusion, RAP is a safe and low-cost technique in reducing the priming volume of the cardiopulmonary bypass system, causes less hemodilution, and reduces the need for intra- and postoperative blood transfusion.
C25 A Direct Comparison between St. Thomas vs. Bretschneider Cardioplegic Solution for Minimally Invasive Mitral Valve Surgery
Christoph Krapf, Philip Sommer, Thomas Schachner, Juliane Kilo, Herbert Hangler, Michael Grimm, Ludwig Müller, Nikolaos Bonaros. Medical University of Innsbruck, Innsbruck, Austria.
Objective: Remote access perfusion and transthoracic clamping allow minimally invasive mitral valve surgery (MIMVS) via mini-thoracotomy. There are two main different cardioplegic solutions used for cardioprotection in MIMVS: intermittent administration of St. Thomas’ or single infusion of Bretschneider solution in the aortic root. The aim of the study was to compare perioperative results in terms of cardio- and nephroprotection in patients who underwent MIMVS.
Methods: From October, 2007, through December, 2012, 330 patients underwent MIMVS at the Department of Cardiac Surgery, Innsbruck. Of them, 194 consecutive patients (Log EuroSCORE=4±5) underwent isolated MIMVS, and were divided to a St. Thomas (ST) and a Bretschneider (BR) group according to the cardioplegic solution used. Perioperative clinical outcomes, as well as laboratory parameters for cardiac and renal injury, were retrospectively evaluated.
Results: There was no difference in perioperative mortality (ST: 3/139 vs. BR: 0/55p=0.272) and ICU-stay (ST: 33±45 vs. BR: 27±19hp=0.138) between the groups. The incidences of perioperative myocardial infarction (0 vs. 0) as well as Risk, Injury, Failure and Loss of the Kidney function according to the RIFLE criteria were also similar (p=0.283). An elaborated investigation of laboratory indicators of myocardial injury revealed increased levels of creatinine phosphokinase (ST: 172±975 vs. BR: 1104±747 mg/dlp=0.02) as well as its myocardial isoenzyme (CK-MB ST: 89±37 vs. BR: 48±22p<0.001) in the ST group. After adjusting for cardiopulmonary bypass and cross-clamp time, this difference remained evident only for the CK-MB (ST: 80±49 vs. 54±27p=0.01). There was no difference in lactate production or the incidence of renal injury, need for renal replacement therapy, or creatinine levels after MIMVS.
Conclusions: Administration of BR cardioplegia was associated with a clinically non-relevant preservation of myocardial enzyme release after MIMVS.
C26 Novel Markers Neutrophil Gelatinase-Associated Lipocalin (NGAL) and Cystatin C in Determining Acute Kidney Injury after Heart Operations using Cardiopulmonary Bypass
Jurij M. Kališnik1, Eva Hrovat1, Alenka Hrastovec1, Aleš Jerin1, Milan Skitek1, Janez Žibert2, Borut Geršak1. 1University Medical Center, Ljubljana, Slovenia, 2Faculty of Health Sciences, Ljubljana, Slovenia.
Objective: Acute kidney injury (AKI) represents frequent complications after cardiac surgery using cardiopulmonary bypass (CPB). The assessment of AKI rests on creatinine levels, which are dependent on many parameters, causing relatively late and less reliable AKI recognition after surgery. We tested the utility of neutrophil gelatinase-associated lipocalin (NGAL) and cystatin C (CysC) for determination of AKI after cardiac surgery using CPB.
Methods: Sixty patients participated in the study, 48 met the inclusion criteria. Arterial blood samples collected after induction of general anesthesia were used as baseline. Further sampling occurred at CPB termination, 2 hours after CPB, and on the first and second day after surgery. Statistical analyses were performed using Student t-testp value <0.05 was considered significant.
Results: According to AKIN classification, 18 patients (38%) developed AKI (AKI group) and 30 did not (nonAKI group). Groups were similar regarding demographics and operative characteristics, except for age and EuroSCORE II in AKI group (77.0±7.1 vs. 70.3±11.4 yrs.; p=0.03, 3.32±2.26 vs. 2.18±1.62; p=0.05, respectively). Preoperative creatinine and glomerular filtration rate were similar between two groups (p=0.11p=0.36, respectively). Creatinine increased significantly on the first postoperative day, whilst NGAL tended to be higher at CPB termination (208.2±81.6 vs. 172.5±59.1μg/l; p=0.09) and remained elevated consistently thereafter (176.2 ±71.6 vs. 139.4±47.2μg/l; p=0.04, 133.9±62.3 vs. 69.2±37.9μg/l; p=0.001, 151.4±106.0 vs. 68.4±40.6μg/l; p=0.005, respectively) in AKI group. CysC started to rise 2 hours after CPB (920.3 ± 253.4 vs. 765.9±270.2μg/l; p=0.06) and exhibited consistently higher levels over time in AKI group (1344.4±581.2 vs. 865.8±260.5μg/l; p=0.003, 1572.2±565.1 vs. 877.0±393.4μg/l; p<0.001, respectively).
Conclusions: Both novel markers NGAL and CysC proved efficient in differentiating between AKI and non-AKI group after heart surgery using CPB. While the postoperative peak of serum NGAL occurred as early as immediately after separating from CPB, CysC reached maximal values later in postoperative course, similarly to creatinine only on the first postoperative day.
CMP23 Perventricular Device Closure of Ventricular Septal Defects: Results in Patients with Age Less 1 Year Old
Alexander Y. Omelchenko, Yuriy N. Gorbatykh, Gregory S. Zaitsev, Alexey N. Arkhipov. Academician E.N. Meshalkin State Research Institute of Circulation Pathology, Novosibirsk, Russian Federation.
Objective: To present and share our experience in perventricular device closure of ventricular septal defects in patients less than 1-year-old.
Methods: Since 2012 till now, 51 patients less than 1-year-old with ventricular septal defects were operated through minimal invasive transthoracic device closure under guidance of transesophageal echocardiography (TEE) without cardiopulmonary bypass (CBP). Median age at operation was 8.0±2.5 (8) months, mean body weight was 7.9±3.4 (7.6) kg; 7.3% (5) of patients had weight less than 5 kg. Qp/Qs ratio was 1.9±0.4 (1.8). VSD size differed from 3 to 9 mm; mean diameter was 5.7±1.6 (5) mm; 27.4% (14) of defects were subaortic, 66.7% (34) perimembranous and 5.9% (3) were muscular. To close the defect, we used a 3-cm skin incision in the lower third of the sternum and a Memo Part tool by Shanghai Shape Memory Alloy Co., Ltd. (Lepu Medical Technology Co., Ltd., Beijing, China), composed of a ventricular septal defect occlusion device SQFDQ I-IV and short occluder delivery system 7F (Fig. CMP23-1).
FIGURE CMP23-1. Comm...Image Tools
Results: The procedure success rate is 96.1% and there were 2 patients that were converted to open-heart surgery (3.9%) during procedures. Operation time «skin to skin» was 55.9±41.0 (40) min; 48.8% of cases were less than 40 min. ICU stay was 16.5±9.4 (18) hours; ventilation time was 3.2±3.5 (2) hours; all patients did not required inotropic support, blood transfusion and analgesia. 7.8% (4) of patients had residual shunt of 1 mm; there were no AV blocks, rhythm disturbances and other types of major complication in early postop period. Hospital stay was 5.6±3.2 (5) days. The 24-month follow-up examination revealed excellent cosmetic results in all patients with no shunts, conduction disturbances, or valve complications in any patient.
Conclusions: Perventricular device closure of ventricular septal defects showed high efficiency, safety in patients of young age with less trauma, comparing to conventional surgical repair with cardiopulmonary bypass, provided short period of rehabilitation and excellent cosmetic result.
CMP24 Hybrid Perventricular Device Closure of Doubly Committed Subarterial Ventricular Septal Defect: A Single-Center Long-Term Results
Ke Lin, Da Zhu. West China Hospital of Sichuan University, Chengdu, China.
Objective: Doubly committed subarterial ventricular septal defect (VSD) is a specific anatomic type of VSD locating just beneath the aortic valve. The purpose of this study is to evaluate the safety and feasibility of using minimal invasive perventricular device closure in managing this type of VSD.
Methods: From July, 2007, through April, 2011, 87 pediatric patients (mean age 7 years) with doubly committed subarterial VSD who met the inclusion criteria for device closure were enrolled. Perventricular closure was facilitated by a unique design eccentric device under the guidance of real-time TEE guidance. Adverse events including residual shunt, valve regurgitation, arrhythmias were recorded in postoperative period and during follow-up.
Results: Perventricular device closure was successfully done 78 patients (90%) with mean VSD size 4.8±1.5mm and mean device size 6.6±1.5mm. 9 patients were converted to open surgical repair due to residual shunt >4 mm (3 patients), obvious aortic regurgitation (4 patients) and device partial detachment (2 patients). Complete closure rate was achieved in 86% at discharge 99% during follow-up (median 4 years). No severe complications such as device embolism, noticeable valve regurgitation and left ventricular outflow tract obstruction were noted during follow-up. Transit type I 2nd degree AV block was noted in 3 patients at 3 years follow-up. Procedure induced trivial-mild grade aortic valve was noted in 11 patients (4 mild/7 trivial) after procedure while 6 of them resolved and only 4 remain (1 mild/4 trivial) during following.
Conclusions: Perventricular closure appears to be safe, effective and minimal invasive technique in selected patient with doubly committed subarterial VSDs with good long-term outcomes.
CMP25 Totally Endoscopic Robotic Ventricular Septal Defect Repair in the Adult
Changqing Gao, Ming Yang. PLA General Hospital, Beijing, China.
Objective: After 600 case of robotic cardiac surgery with da Vinci Surgical System, the optimal results encouraged us to extend the use of this technology to more complicated patients with ventricular septal defect.
Methods: From January, 2009, to November, 2013, 25 patients underwent total endoscopic robotic ventricular septal defect repair. The average patient age was 29.0±9.8 years (range, 14∼45). Of the 20 patients, 9 were female and 16 were male. The echocardiogram demonstrated that the average diameter of the ventricular septal defect was 6.2±2.6mm (range, 2∼15), and 4 patients had concomitant patent foramen ovale. Ventricular septal defect closure was directly secured with interrupted mattress sutures in 18 patients and patched in 7 patients. All the procedures were completed using the da Vinci robot by way of 3 port incisions and a 2.0- to 2.5-cm working port in the right side of the chest.
Results: All patients were operated on successfully. The mean cardiopulmonary bypass and mean crossclamp time was 101.53±32.3 minutes (range, 66∼140) and 42.6±30.1 minutes (range, 22∼75), respectively. The mean operation time was 204.9±36.8 minutes (range, 180∼300). The postoperative transesophageal echocardiogram demonstrated an intact ventricular septum. No residual left-to-right shunting and no permanently complete atrioventricular dissociation was found postoperatively. The mean hospital stay was 5 days. No residual shunt was found during a mean follow-up of 28 months (range, 1∼49). The patients returned to normal function within 1 week without any complications.
Conclusions: Total endoscopic robotic ventricular septal defect repair in adult patients is feasible, safe, and efficacious.
CMP26 Long Term Patency of Endoscopically Harvested Radial Artery from a Randomized Control Trial
Daniel J.P. Burns, Stuart A. Swinamer, Stephanie A. Fox, Jonathan Romsa, William Vezina, Cigdem Akincioglu, James Warrington, Lin-Rui Guo, Michael Wa Chu, Mackenzie A. Quantz, Richard J. Novick, Bob Kiaii, London Health Sciences Center, London, ON Canada.
Objective: From 2005-2007, 119 patients were enrolled in a prospective randomized controlled trial comparing open and endoscopically harvested radial arteries for coronary artery bypass grafting (CABG). This trial showed equivalent postoperative arm disability, and in the endoscopic group, postoperative arm pain, cosmesis, and patient satisfaction were significantly improved, with a trend toward a significant decrease in wound infections observed. The objective of the current study was to compare graft patency between open and endoscopically harvested radial arteries at greater than 5 years from involvement in the stated trial. We hypothesized that endoscopically harvested radial arteries would show equivalent patency.
Methods: All patients received calcium channel blocker therapy for at least 6 months postoperatively. The mean duration of follow-up was 79.2 (+/- 8.6) months for all patients. At 5 years or greater from their operation, all consenting patients underwent a single-day anatomic and functional cardiac assessment with CT angiography and sestamibi myocardial perfusion scanning. Medical Outcomes Study 36-Item Short Form Health Surveys and Seattle Angina Questionnaires were completed to assess overall quality of life.
Results: Two deaths occurred within 30 days of CABG (one in each treatment group) and 8 additional non-cardiac deaths occurred over the study timeframe. Of 119 patients, 66 consented to follow-up. Thirty-two had open radial artery harvest and 34 had endoscopic radial artery harvest. In the open group, there were 11 obtuse marginal, 16 posterior descending, 1 posterolateral, and 4 right coronary grafts. In the endoscopic group, there were 7 obtuse marginal, 14 posterior descending, 3 posterolateral, 1 circumflex, 1 diagonal, 1 ramus intermedius, and 7 right coronary grafts. There were 28 (87.5%) patent conventionally harvested radial arteries and 31 (91.2%) patent endoscopically harvested radial arteries (p=0.705). Measured quality of life was comparable between groups.
Conclusions: Endoscopic radial artery harvest is safe and effective when compared to open radial artery harvest, with equivalent graft patency shown at greater than 5 years.
CMP27 Functional and Histological Analysis of the Radial Artery: Comparison of Open Vs. Endoscopic Vessel Harvesting
Stefan C. Sandker1, Ron G.H. Speekenbrink1, Robert P.H. Storm van Leeuwen 1 Gianclaudio Mecozzi1, Gert-Jan Toes2, Hendrik Buikema3, Jan G. Grandjean1. 1Thoraxcenter Twente, Enschede, Netherlands, 2Laboratorium Pathologie Oost Nederland, Hengelo, Netherlands, 3Department of Clinical Pharmacology, University Medical Center Groningen, Groningen, Netherlands.
Objective: Over the past two decades the radial artery has regained its popularity as bypass graft. However, vasospasm of the radial artery graft is correlated to early graft failures in CABG. Endoscopic vessel harvesting results in fewer wound complications and is cosmetically superior compared to the open technique, but may injure the graft and promote vasospasm. We investigated vascular function in organ bath experiments and analyzed the histological structure of radial arteries harvested by either a latest generation endoscopic vessel harvesting system or open technique.
Methods: In this prospective trial, the radial artery was harvested using the open (n=14) or endoscopic (n=29) technique, based on surgeons preference, of patients undergoing CABG. Surplus proximal radial artery segments were collected and pairwise assessment of vasoreactivity to acetylcholine, nitroglycerin, norepinephrine and potassium chloride was performed in organ bath experiments. Histological assessment was done by an expert pathologist and sections were stained with hematoxylin-eosin, Verhoeff van Gieson’s and CD31 (open: n=9, endoscopic: n=6).
Results: Endothelium dependent and independent vasorelaxation to respectively acetylcholine (p=0.912) and nitroglycerin (p=0.563) was similar for endoscopically harvested compared to open harvested radial arteries. Vasoconstriction to norepinephrine (p=0.429) and potassium chloride (p=0.756) was similar for open and endoscopic harvested radial arteries (Fig. CMP27-1). Histological examination showed an intact endothelium, some intima fibrosis and intact media layer in all radial artery sections for both techniques. All artery segments showed no signs of acute vessel damage or inflammation.
FIGURE CMP27-1. Vasc...Image Tools
Conclusions: Vascular function and histological structure of the radial artery is not altered by the latest generation endoscopic vessel harvesting system compared to the open technique. Therefore, we suggest that endoscopic vessel harvesting of the radial artery in CABG is a good alternative compared to open vessel harvesting. In sight of wound complications and cosmetics, endoscopic vessel harvesting of the radial artery should be encouraged.
CMP28 Minimal Trauma Radial Artery Harvesting Using a New Reusable Endoscopic Retractor and Tissue Welding Technology
Mani Arsalan, Alexander Meyer, Johannes Blumenstein, Sina Schmidt, Heike Baumgarten, Thomas Walther, Jörg Kempfert. Kerckhoff Clinic, Bad Nauheim, Germany.
Objective: The percentage of endoscopic vessel harvesting is rising since it was introduced in 1997. One problem still preventing further increase of this minimal invasive technique are cost issues. Therefore, a reusable retractor Mi-Trak (Fig. CMP25-1A) combined with disposable Thermal Ligating Shears TLS2 (Microline Surgical, Beverly, MA USA; Fig. CMP28-1B) was developed. Additionally, to the cost aspect, this device is slimmer in its design compared to other radial artery harvesting retractors. We report our very first series of harvesting procedures performed with this new device combination.
Methods: We performed 20 endoscopic radial artery harvesting with the Mi-Trak retractor and the TLS2 Thermal Ligating Shears. Harvesting time, postoperative bleeding, incision and graft length were measured.
FIGURE CMP28-1. Mi-T...Image Tools
Results: All radial artery harvesting could be performed without a counterincision or conversion to open technique. The harvesting time and graft length were comparable to data reported for other endoscopic radial artery harvesting devices. Incision length was about 2 cm. 24-hour postoperative bleeding was below 20 ml.
Conclusions: Using the combination of a reusable and disposable device, we could show that radial artery graft harvesting could be performed safe with reduced cost. Due to the slimmer design of the retractor, harvesting could be performed through a very small single skin incision and tissue tunnel. This reduces possible tissue trauma to a minimum of about 1 cm around the radial artery with very low bleeding. This “more minimal invasive” technique neither affects harvesting time nor graft length.
CMP29 Endoscopic Radial Artery Harvesting Combining a Reusable Retractor With a Nanoscale-controlled Radiofrequency Vessel Sealing System: Early Histological Analysis and Late Clinical Outcomes
Gianluigi Bisleri1, Laura Giroletti1, Tomasz Hrapkowicz2, Jerzy Nozyski2, Marian Zembala2, Claudio Muneretto1. 1University of Brescia Medical School, Brescia, Italy, 2Silesian Center for Heart Diseases, Zabrze, Poland.
Objective: Despite the proven clinical advantages of an endoscopic approach over a conventional technique for radial artery harvesting, there are potential concerns about conduit damage occurring during minimally invasive procurement which could lead to late graft failure. We, therefore, sought to investigate the histological features of radial artery conduits immediately after endoscopic harvesting and the potential correlation with late clinical outcomes.
Methods: In 36 patients undergoing CABG surgery, radial artery harvesting was performed by means of an endoscopic (non-sealed) technique combining a reusable stainless steel retractor and a nanoscale-controlled bipolar radiofrequency device as a vessel sealing system. Immediately after endoscopic harvesting, a sample of the radial artery was fixated with 6% neutral formalin solution and embedded in paraffin; histological analysis of five micron sections by means of hematoxylin-eosin, Masson trichrome and acid orcein was performed and a semiquantitative 0- to 4-point scale utilized in order to grade potential conduit wall damage. A clinical follow-up was performed in all patients.
Results: Endoscopic radial artery harvesting was successfully completed in all cases (mean harvesting time: 29±4 minutes) without intra-operative complications. No bleeding from the sealed side branches requiring additional clip application was required. Histological analysis did not reveal significant acute pathological changes occurring to the radial artery integrity either in terms of endothelial loss (0.9±0.4), injury to the internal lamina elastica (0.5±0.3), adventitial hemorrhage (0.5±0.2), vasa vasorum heat-related damage (0.1±0.3) and margination of white blood cells (0.6±0.3). The post-operative period was uneventful in all cases. Mean follow-up was 1893+546 days; cardiac-related late mortality occurred only in 1 patient (patent RA on autopsy). Coronary angiography was performed in 5 patients due to angina recurrence; excellent graft patency (Fitzgibbon grade A) was detected in all radial artery conduits.
Conclusions: Endoscopic harvesting of the radial artery with a non-sealed approach combining a reusable stainless steel retractor with a nanoscale-controlled bipolar radiofrequency vessel sealing system was associated with negligible damage to the integrity of the radial artery graft at histological analysis immediately after harvesting. Moreover, no detrimental effects of this approach could be detected at mid-long term follow-up as confirmed by the excellent clinical and angiographic results.
CV5 3D Endoscopic Harvesting of Left Internal Thoracic Artery Using Harmonic Scalpel
Takahiro Takemura, Yujirou Kawai, Hirokazu Miitsu, Gentaku Hama, Yasuyuki Yoyota, Yasutoshi Tsuda, Kazuaki Shiratori. Saku Central Hospital, Saku, Japan.
Objective: An important step of minimally invasive coronary artery bypass grafting is harvesting of the left internal mammary artery (LIMA). Harvesting of the LIMA is usually performed under direct vision via mini thoracotomy or using robotic assistance. However, complete graft harvesting of the IMA is difficult under direct vision and robotic assistance is not usually used in our country and requires high costs.
Methods: A 30 degree rigid 3D endoscope was inserted through a 11-mm port in the 5th or 6th intercostal space (ICS) at the anterior axillary line. The dissection instrument (Ultracision Harmonic Scalpel) was inserted (5-mm port) in the 4th or 3th ICS at the anterior axillary line and the endo forceps (5-mm port) in the 4th or 5th ICS mini lateral thoracotomy.
Results: 3D endoscopic harvesting of LIMA permits dissection from subclavian artery to the 5th intercostal space. It was performed by the technique of skeletonization as same quality as usual procedure thorough full sternotomy.
Conclusions: Ultrasonic harvesting of a skeletonized IMA using 3D endoscope is a non-traumatic preparatory technique that reduces the costs and that can be performed safely and with good quality.
C27 Pressure Controlled Vein Graft Flushing Results in Superior Histological Quality: A Randomized Trial
Mani Arsalan, Jörg Kempfert, Sebastian Bader, Alex Meyer, Heike Baumgarten, Sina Schmidt, Johannes Blumenstein, Thomas Walther. Kerckhoff Clinic, Bad Nauheim, Germany.
Objective: The saphenous vein is still one of the most commonly used grafts for coronary artery bypass grafting. Nevertheless, several studies show an inferior long-term patency compared to arterial grafts. This could be due to the histologic structure of the vein as it is not intended for a high pressure system. Another issue might be due to the intraoperative handling of the graft. It could be shown that by flushing the graft during harvesting and preparation, accidental peak pressures over 600 mmHg occur inside the vessel. This might lead to endothelial damage of the graft and thus reduce quality and subsequently patency. Thus, controlling the flushing pressure could prevent endothelial damage. Therefore, we investigated whether the usage of a pressure limited syringe influences graft quality and endothelial function.
Methods: In a randomized trial, 50 patients underwent vein harvesting during CABG using a conventional or a pressure limited syringe (Vasoshield, MAQUET Cardiovascular LCC, Wayne, NJ USA) limited to 250 mmHg (Fig. C27-1A). ENOS Western blot analyses demonstrated a significantly greater nitric oxidase production in the pressure limited syringe group. This could be confirmed by eNOS immunostaining (Fig. C27-1B).
Results: CD31 immunostaining revealed that endothelial cell integrity in the pressure limited syringe group was 73.2±14.5% of the circumference of luminal endothelium, compared to the conventional syringe group 46.2 ± 21.4% (p<0.05). ENOS Western blot analyses demonstrated a significantly greater nitric oxidase production in the pressure limited syringe group.
Conclusions: Our randomized study demonstrates that usage of a pressure limited syringe is capable of reducing histological damages and preserving endothelial function of the saphenous vein graft. Apart from the limited additional costs there seem to be no downsides in using this approach and it might lead to a better vein graft patency.
CMP30 The Nonocclusive Laser Assisted Anastomotic Connector: A Pilot Study in a Small Caliber Porcine Off-Pump Coronary Artery Bypass Model
FIGURE C27. A, Press...Image Tools
David Stecher, Gerard Pasterkamp, Lex A. van Herwerden, Marc P. Buijsrogge. University Medical Centre Utrecht, Utrecht, Netherlands.
Objective: In this pilot study, the initial feasibility, patency, and anastomotic healing of the novel oval-shaped small caliber Trinity Clip, based on the Excimer Laser Assisted Nonocclusive Anastomosis (ELANA) technique, were assessed in the acute and mid-term follow-up in a small caliber porcine OPCAB model.
Methods: The implantable connector is suitable for coronaries with a minimal diameter of 1.2 mm. Nonocclusively, the graft is connected to the coronary, and a laser opens the anastomosis. In the porcine model (n=5 pigs), LITA-to-LAD bypasses were evaluated by flow measurements intraoperatively (n=5) and at 5 hours (n=3), and by angiography and histology at 5 weeks (n=2) follow-up.
Results: The Trinity Clip enabled fast (mean 3.2±0.4 minutes) anastomotic construction without proximal snaring of the coronary, and in all anastomoses complete hemostasis was demonstrated. All anastomoses were fully patent with a FitzGibbon Grade A at 5-weeks follow-up. The mean peak hyperemic flow response (peak flow [following 30 second-graft occlusion] divided by the baseline flow [23±10 mL/min]) was 5.4±0.9. At 5-weeks follow-up, streamlining neointima coverage of the connector was observed along the full circumference of the anastomosis.
Conclusions: The Trinity Clip is easy-to-use and feasible on clinically relevant small caliber coronary arteries in the porcine off-pump bypass model. Hence, this facilitated nonocclusive coronary anastomosis technique has potential for minimally invasive coronary bypass surgery. The safety and quality on the long-term will be assessed in a preclinical study prior to clinical testing.
CMP31 Robot-Assisted Endoscopic Construction of a LITA-to-LAD Anastomosis Facilitated by the Trinity Clip (ELANA Anastomotic Connector): An Experimental Case Report
David Stecher1, Lex A. van Herwerden1, Gerard Pasterkamp1, Marc P. Buijsrogge1, Bob Kiaii2. 1University Medical Centre Utrecht, Utrecht, Netherlands, 2London Health Sciences Centre, London, ON Canada.
Objective: To facilitate minimal access CABG, our research group developed a potential simplified alternative for hand-sutured anastomosis, the Trinity Clip, based on the Excimer Laser Assisted Nonocclusive Anastomosis (ELANA) technique. The submitted video demonstrates the very first experience with robot-assisted endoscopic application of the experimental anastomotic technique.
Methods: In an acute porcine OPCAB model, a LITA-to-LAD bypass was constructed with the new Trinity Clip by using the Intuitive da Vinci Si Surgical System (by an inexperienced robotic surgeon [first author]), after conventional harvesting of the LITA. The robotic arms and the laser were introduced through a median sternotomy. The implantable connector is suitable for coronaries with a minimal diameter of 1.2 mm. Nonocclusively, the graft is connected to the coronary, and a laser opens the anastomosis.
Results: The anastomotic procedure was feasible, with successful application of the mounted complex (i.e., graft, connector, and laser, temporarily fixated by a fixation clip) onto the LAD. Access to the diagonals or a high marginal branch was possible. After laser-punching the LAD, a failure of completely releasing the fixation clip (i.e., accidentally the fixation clip caught the LITA and, subsequently, the surgeon applied uncontrolled traction onto the LITA) resulted in rupture of the anastomosis.
Conclusions: The anastomotic technique was feasible in a porcine OPCAB model in an endoscopic setting, robot-assisted, in a single case. However, the mounted and secured laser limited expediency. A more flexible laser and a simplified application of the fixation clip will further optimize the procedure, which has potential to facilitate endoscopic minimally invasive OPCAB surgery.
CMP32 Redo Coronary Bypass via Thoracotomy Approach
David G. Harris1, Andre Saaiman2, Gabriel J. Rossouw1. 1Tygerberg Hospital, University of Stellenbosch, Cape Town, South Africa, 2Kuils River Private Hospital, Cape Town, South Africa.
Objective: Repeat coronary artery bypass has increased risks including injury to a patent left internal mammary to left anterior descending (LIMA-LAD) graft. Thoracotomy is advocated specifically in patients with intact LIMA-LAD grafts needing lateral wall grafting.
Methods: From 2000 to 2012, 88 patients underwent surgery. Mean age was 63.2 (41-82), and age at previous operation was 52.0 years (29-69). Six (6.8%) had their third operation. Comorbidities were diabetes (48.8%), renal impairment (12.5%), calcified aorta (17.1%), carotid disease (9.0%), and peripheral vascular disease (27.3%). Eleven (12.5%) had a pre-operative intra-aortic balloon pump. Predicted mortality (logistic EuroSCORE) was 12.1%.
Results: Sixty-six patients (75%) had intact LIMA-LAD grafts. Fifteen patients (17%) had stents placed during the same admission, as a hybrid procedure. Forty patients (45.4%) had 1 distal graft, 46 patients (52.3%) had 2 grafts, and 2 patients (2.3%) had three distal grafts performed. The LIMA was used in 9 patients, where it had not been used before. There were 139 distal grafts (including 9 sequential grafts). A total of 82 venous, and 45 radial artery grafts were used. Proximal graft site was proximal descending aorta 30.7%, distal aorta in 54.7%, and subclavian in 14.6%. In 11 patients (12.5%) the distal branches of the right coronary (posterior descending or right posterolateral) were grafted. Mean blood loss/24 hours was 436 mls (125-1100); mean ventilation time was 6.8 hours (0-12), ICU stay 3.7 days (2-8), and hospital stay 6.3 days (3-20). There were no major complications. There was one death. There were two late deaths. Fourteen patients underwent repeat cardiac catheterization.
Conclusions: The left thoracotomy redo is safe, especially in patients with intact LIMA-LAD grafts. The in-hospital death rate (1.1%) compares well with the EuroSCORE predicted mortality (12.1%). The technique has been refined over the latter half of the study, using a smaller less invasive incision. As a result, patients previously thought unsuitable or less worthwhile for surgery are now being referred. Most cardiologists are not aware of this procedure, so we now consider it essential to mark the site of the proximal graft on the descending aorta with a formal coronary marker.
CMP33 Immediate- and Long-Term Outcomes with Angiographic Follow-Up of Single Stage Hybrid Revascularization
Bob Kiaii, Michael Chu, Kumar Sridhar, Wojciech B. Dobkowski, Christopher Harle, Philip Jones, Stephanie A. Fox, Daniel Bainbridge, Patrick Teefy. London Health Sciences Center, London, ON Canada.
Objective: Traditionally integrated coronary artery revascularization has been described as a two-stage procedure. We evaluated the safety and feasibility of single-stage simultaneous and two-stage hybrid robotic-assisted coronary artery bypass grafting surgery and percutaneous coronary intervention (PCI).
Methods: 108 patients underwent simultaneous integrated coronary artery revascularization in an operating theatre equipped with angiographic equipment. 78 were male and mean age was 61 years. All internal thoracic arteries were harvested with robotic-assistance, and anastomoses were manually constructed through a small anterior non-rib spreading incision or closed chest robotic assistance without cardiopulmonary bypass on the beating heart. Immediately afterwards within the same operative suite, angiographic confirmation of graft patency and PCI with drug-eluting stents were performed. In 82 patients therapeutic anticoagulation was achieved using the direct thrombin inhibitor bivalirudin.
Results: There were no deaths or wound infections. There was one peri-operative myocardial infarction. One patient suffered a stroke and four patients required re-exploration for bleeding. Median length of stay in the intensive care unit was 1 day and length of hospital stay was 4 days. All patients were alive and symptom free at 84 months follow-up. Long-term follow-up angiogram at mean 10 months of 71 patients showed 2 atretic and 4 non-patent grafts; otherwise, the remainder of the grafts were all patent with 8 in-stent stenosis and 2 occluded stents. At mean 5-year follow-up, the patency rate of LITA was unchanged at 95.
Conclusions: For multi-vessel coronary artery disease, simultaneous hybrid robotic-assisted coronary artery revascularization using bivalirudin is safe and feasible. This approach allows complete multi-vessel revascularization with decreased surgical trauma and post-operative morbidity with very good long-term outcome. Randomized control trials are necessary to better determine long-term benefits of this technology.
CMP34 Medium-Term Follow-Up in a Single-Center Practice of EndoACAB and Hybrid Robotic Coronary Revascularization
Rashmi Yadav, Saina Attaran, Richard Trimlett, Mindaugus Norkunas, Philip Kimberley, Eleanor Dunnett, John Pepper, Anthony C. DeSouza. Royal Brompton Hospital, London, United Kingdom.
Objective: Endoscopic atraumatic coronary bypass (EndoACAB) has become an attractive treatment option in single-vessel disease revascularization and has been adopted in our unit since 2000. In selected cases, a hybrid approach was introduced in 2006 to reduce surgical trauma of median sternotomy for multi-vessel disease. We report our experience and short- and medium-term results of these procedures.
Methods: Retrospective review of all patients undergoing EndoACAB and hybrid revascularization was performed. After a multi-disciplinary meeting, suitable patients for EndoACAB and hybrid approach were identified. The left internal mammary artery (LIMA) was harvested endoscopically. Through a non-rib spreading anterior microthoracotomy, LIMA was anastomosed to the LAD off-pump. On the third or fourth postoperative day, PCI to the remaining vessels was performed. Outcomes included mortality, morbidity and length of post-operative stay.
Results: Overall, 367 patients were planned to have EndoACAB. Excluding unstable cases or instrument failure, the conversion rate to conventional sternotomy was 4.8%. 25% of patients had multivessel disease and underwent PCI after EndoACAB. There was no in-hospital mortality or stroke. Resternotomy for bleeding was 1.5%. Wound infection and renal failure were less than 2%. Adverse outcomes such as anastomosis of diagonal, poor runoff and bleeding from anastomosis requiring conventional surgery were also 1.5%. Post operative length of stay was 6.354±0.2636. Median follow-up was 3.5 years with survival of 97.5% patients. Of the above cohort, 92 patients were treated using the hybrid strategy with PCI to the circumflex and/or right coronary territories. No adverse outcomes were reported. Narrowing of the LIMA to LAD anastomosis was identified in one case, which was stented via the LIMA graft. There was no postoperative mortality and five-year survival was 97%.
Conclusions: EndoACAB carries a low risk of morbidity and mortality, with the advantage of prognostic benefit of LIMA to LAD anastomosis. In selected cases, the hybrid approach carries a low risk of postoperative complications. Medium-term survival with both procedures is excellent. Hybrid coronary revascularization may combine the best of both worlds thereby providing a viable alternative to conventional coronary revascularization.
CMP35 Isolated Occlusion of Proximal LAD: A Stent or BH TECAB?
Vidadi Efendiev, Sergey Alsov, Alexey N. Arkhipov, Vitaliy Baystrukov, Nikita Kravchenko, Alexander Chernyavskiy*, Academician E.N.Meshalkin State Research Institute of Circulation Pathology, Novosibirsk, Russian Federation.
Objective: In case of isolated left anterior descending artery (LAD) occlusion, it is important to minimize the possible risks and perform efficient myocardial revascularization. It is still not clear which method is preferential: percutaneous coronary intervention (PCI) with stenting or totally endoscopic coronary artery bypass on beating heart (BH TECAB). The goal of this study was to compare the outcome of patients with isolated occlusion of LAD after PCI with stenting or BH TECAB using the da Vinci Surgical System (Intuitive Surgical, Sunnyvale, CA USA).
Methods: Patients with isolated occlusion of proximal segment of LAD were randomized for PCI with stenting (n=40) and BH TECAB (n=40). They were followed-up during one to two years (average, 17 months). The first end-point was the freedom from major adverse cardiovascular and cerebrovascular events (MACCEs), including cardiac death, myocardial infarction, stroke and redo CABG or PCI of LAD. The second end-points were angina class and need in antianginal medications during the follow-up period.
Results: 12.5% of patients after PCI with stenting had MACCEs versus 2.5% of patients after surgical revascularization (p=0.02). Freedom from angina in case of PCI was 77.5% and 95% after BH TECAB (p=0.022). The need for antianginal therapy was significantly lower after surgery in comparison with PCI (p=0.002).
Conclusions: Beating heart TECAB showed significantly better results in outcome of patients with isolated occlusion of proximal segment of LAD during follow-up period comparing with PCI.
* shared last authorship