CMP1 Towards Biomechanical Analyses for Predictive Planning of Transcatheter Aortic Valve Implantation
Michael Gessat1, Christoph Russ2, Raoul Hopf2, Simon H. Sündermann1, Sven Hirsch2, Edoardo Mazza2, Gábor Székely2, Volkmar Falk1. 1University Hospital Zürich, Zürich, Switzerland, 2Swiss Federal Institute of Technology (ETH) Zürich, Zürich, Switzerland.
Objective: Transcatheter aortic valve implantation (TAVI) is an effective treatment for severe aortic stenosis in high-risk patients but causes complications, such as AV-blocks, paravalvular leaks, vascular complications, and annular rupture. Valve selection, sizing, and positioning are critical for reducing the risk for these complications. Geometric parameters, such as annular diameter or cross-sectional area and distance to the coronary ostia are currently considered during implantation planning. Biomechanical analyses may add a new perspective to preoperative TAVI planning. We present the current state of developments aiming at providing tools for patient-specific prediction of the biomechanical situation in the aortic root after TAVI.
Methods: Stent geometry was extracted from micro-CT. Mechanical models of TAVI stents were created using micro-CT imaging and literature values for the material parameters of Nitinol. The reliability of these models was evaluated experimentally. Patient-specific anatomical models were created from CT images of six patients. The mechanical characteristics of the tissues were added based on biomechanical models and parameters from literature. Verification of these models was performed using tissue samples from patients undergoing surgery at the aortic root or ascending aorta. In-silico prediction of the displacement of tissues and the contact forces induced by valvuloplasty and stent implantation was performed with the Finite Element Method (Figure CMP1-1). Stent models extracted from post-operative CT images were used for validation.
Results: The reliability of the predictions is influenced by the choice of tissue models and parameters. With a reasonably accurate and yet not overly complex non-linear model, the prediction of radial strain after stent implantation, characterized by the change in circumference of the aortic annulus and ascending aorta, is accurate within an error margin of 10%. Since calcifications were not sufficiently taken into account, errors were larger in cases with severe calcifications.
Conclusions: Patient-specific modeling of the aortic root for predicting the biomechanical situation during and after TAVI is feasible. Yet, there remain unanswered questions regarding the trade-off between model complexity and accuracy and the representation of calcium.
CMP2 Transcatheter Aortic Valve Implantation: When It’s Time to Convert
Philipp Kiefer, Joerg Seeburger, David Holzhey, Marcel Vollroth, Thilo Noack, Friedrich W. Mohr. Heart Center Leipzig, Leipzig, Germany.
Objective: Transcatheter aortic valve implantation (TAVI) has emerged as an important treatment for patients with severe symptomatic aortic stenosis who are at high-operative risk. Two different approaches, the transfemoral and transapical techniques, are currently under intense clinical investigation. The aim of this study was the evaluation of intraoperative complications and the conversion rate to full sternotomy.
Methods: A total of 1825 (1153 transfemoral (TF), 672 transapical (TA)) patients underwent TAVI since July 2006 at our institution. Conversion to full sternotomy was required in 2.1% of all patients (n=38; 21 TF and 17 TA). Patient data, including intraoperative course and postoperative outcome, were collected. Follow-up data were collected in a prospective database and retrospectively analyzed.
Results: A total of 38 patients underwent conversion to full sternotomy during TAVI. The mean age of patients was 84.5±5.3 years, 32 patients were female (88%), and the mean log EuroSCORE was 21.7±16.3. The main reasons for conversion were as follows: perforation of the left ventricle in 26% (n=10; 6 TF, 4 TA); malpositioning of the valve in 24% (n=9; 5TF, 4 TA); occlusion of the coronaries in 18% (n=7; 3TF, 4TA); and rupture of the annulus in 18% of the patients (n=7; 5TF, 2TA). Perioperative mortality (30 days) was 58% (n=23; 14 TF, 8 TA).
Conclusions: This trial indicates that TAVI is associated with reasonable low intraoperative complication rates. In the experience of this large single-center study, conversion to full sternotomy was necessary in only 2% of all patients. If conversion is indicated, however, it is associated with high perioperative risk.
C1 Mid- to Long-Term Outcomes after Transcatheter Aortic Valve Implantation
Shahram Lotfi1, Guido Dohmen2, Andreas Götzenich1, Marcus Haushofer1, Jan Spillner1, Rüdiger Autschbach1, Rainer Hoffmann3. 1Department of Thoracic and Cardiovascular Surgery, RWTH University Clinics Aachen, Aachen, Germany, 2Department of Cardiac, Thoracic and Vascular Surgery, St.-Johannes-Hospital, Dortmund, Germany, 3Department of Cardiology, RWTH University Clinics Aachen, Aachen, Germany.
Objective: Transcatheter aortic valve implantation (TAVI) has become a therapeutic option for high-risk or non-operable patients with severe symptomatic aortic valve stenosis. The best known and most frequently implanted prostheses are CoreValve and SAPIEN prostheses. We report our experiences and analyze the results of our TAVI program.
Methods: 367 patients underwent TAVI in our center between January 2008 and October 2012. The procedure was performed in 197 patients with CoreValve, in 158 patients with SAPIEN and in 12 patients with ACURATE TA prostheses. Transfemoral (TF) access was used in 190 patients. In 167 patients transapical (TA) access was used. Transaortic and trans-subclavian access were chosen in 8 and 2 patients. The mean age was 80.6 ± 6.4 years. All patients were non-operable or had a high risk for a conventional aortic valve replacement. The mean logistic EuroSCORE was 25.32±14.51%. The TF/CoreValve (190 patients) and TA/SAPIEN (155 patients) groups showed no significant difference in patients mean age (81.7±6.3 years vs. 79.5±6.6 years) but a significant difference in mean logistic EuroSCORE (22.16±13.05% vs. 31.04±16.40, p<0001).
Results: Overall-30d-Mortality (367 patients): 9.54% (TF 8.42%, TA 11.31%). Overall-1Y-Mortality (275 patients): 21.45% (TF 23.74%, TA 19.12%). Overall-2Y-Mortality (199 patients): 29.15% (TF 35.96%, TA 23.64%). Overall-3Y-Mortality (133 patients): 37.59% (TF 43.86%, TA 32.89%). Overall-4Y-Mortality (38 patients): 39.47% (TF 45%, TA 33.33%). The rate of pacemaker implantation after TAVI was in CoreValve-group significantly higher than in SAPIEN-group: 45.17% (89 of 193 patients) vs. 6.33% (10 of 158 patients) p<0001. Stroke rate was in TF-CoreValve-group higher than in TA-SAPIEN-group: 4.21% vs. 0.064%, p=0.045 (Figure C1-1).
Conclusions: Outcomes after TAVI were in our population of non-operable and high-risk patients encouraging. The differences in mid- and long-term outcomes between TF-CoreValve-TAVI and TA-SAPIEN-TAVI were not significant, but showed a tendency in advantage of TA-group. The learning curve included not only peri- and intraoperative, but also pre- and postoperative improvements in treating of this special group of high-risk patients.
C2 Does Left Ventricular Hypertrophy Affect Outcomes in Patients Undergoing Transcatheter Aortic Valve Replacement?
Nimesh Desai, Wilson Y. Szeto, Tyler Wallen, Saif Anwarrudin, Daniel Choudhary, Howard Herrmann, Joseph Bavaria. University of Pennsylvania, Philadelphia, PA USA.
Objective: Severe left ventricular hypertrophy (LVH) has a well documented severe negative impact on early mortality in patients undergoing surgical aortic valve replacement. This effect is particularly pronounced in patients with elevated relative wall thickness, an indicator of extreme hypertrophy with small ventricular cavity (suicide ventricle). It is not clear whether similar mortality risk is present in transcatheter aortic valve replacement (TAVR), which avoids issues regarding myocardial protection and hyperdynamic post-bypass physiology. The purpose of this study is to analyze the impact of LVH on patients undergoing TAVR.
Methods: From 2008-2011, a retrospective review of patients undergoing TAVR was performed, comparing patients without severe LVH (n=59) to those with severe LVH (group 2, n=89). LVH was defined as a relative wall thickness (2×Posterior wall Thickness/LVEDD) of greater than 0.5. Data was abstracted from a prospectively kept database with robust echocardiographic and clinical follow-up.
Results: Preoperative age, STS score, and aortic valve area did not differ (age: 81 vs. 84 years; STS score 12 vs. 12; AVA 0.61 vs. 0.61cm2, no LVH versus severe LVH groups respectively). Peak gradient (PG) was higher in severe LVH group (PG 79 vs. 84mmHg, p<0.0001) but mean gradient (MG) did not differ (MG: 47 vs. 49mmHG, p=NS). The severe LVH group had a higher LV ejection fraction (p<0.001), higher preoperative pulmonary artery pressures (p<0.001), worse mitral and tricuspid regurgitation (p<0.01). There was no difference in peri-procedural mortality (6.8% vs. 7.8%, p=0.5). There were not differences in ventilation time, inotrope use or overall length of stay between groups. At 1-year follow-up, mortality rates did not differ (29 vs. 25%, p=0.3). PG and MG did not differ (PG: 23 vs. 24mmH, MG: 12 vs. 12mmHg). LV mass regression did not differ between groups. The severe LVH group continued to have a higher ejection fraction (59 vs. 67%, p<0.001).
Conclusions: Unlike surgical AVR patients, the presence of severe left ventricular hypertrophy in patients undergoing TAVR was not correlated with adverse outcomes at 1 year.
CMP3 Enhanced Survival and Decreased Paravalvular Leakages after Mitral Valved Stent Implantation: A Technology Update
Saskia Pokorny1, Katharina Huenges1, Telse Bähr1, Huang D. Dai1, Martin Marczynski-Bühlow1, Michael M. Morlock2, Jochen Cremer1, Georg Lutter1. 1University Hospital Schleswig-Holstein, Campus Kiel, Kiel, Germany, 2Hamburg University of Technology, Hamburg, Germany.
Objective: Off-pump implantation of a valved stent into the mitral position has been in the focus of innovative research lately. This study presents the most recent results of transapical implantation of our newest mitral valved stent design in a porcine model one and two months after implantation.
Methods: Eight pigs received a self-expanding valved stent with improved stent design (shape, size) into the mitral position via transapical approach. Hemodynamic stability, stent function and positioning were assessed before (n=8) and 1 hour after implantation (n=8), at one month (n=4) and at outstanding health of the animal at two months (n=1) using TEE, invasive pressure measurements, ventriculography, and cardiac CT.
Results: Reliable stent stability and good positioning were achieved in all animals. One animal died of cardiac fibrillation during surgery and three animals died within the first month (7±3 days) due to endocarditis. TEE evaluation showed normal gradients and echocardiographic parameters, but decreasing MAPSE after implantation (p=0.004). PA and PCWP pressure did not change throughout the observation period (p≥0.16). MAP decreased directly after implantation (p=0.002) and stabilized hereafter (p≥0.25; Table CMP3-1). No paravalvular leakages (PVL) were detected directly after implantation. After one month, no PVL were found in two animals; one animal had trace and one mild PVL. Central mitral regurgitation was observed in five of eight animals directly after implantation (n=1: none to trace, n=3: trace, n=1: mild) and in two of four animals after one month (n=1: trace, n=1 mild). Gross evaluation demonstrated correct stent position in all and no thrombus formation in all but one animal. Ingrowth within the native structures of the left atrium was 72±24% after one month and 87% after two months.
Conclusions: Reliable stent stability, minimal gradients and adequate stent function were observed throughout the study at a high degree of reproducibility over a post-operative period of up to two months. In particular, the occurrence of PVL was reduced with this newly developed prototype.
C3 Twelve-Month Registry Results of a Newly Approved Transapical Aortic Bioprosthesis: ACURATE TA
Joerg Kempfert1, Hendrik Treede2, David Holzhey3, Steffen Hoffmann4, Evaldas Girdauskas5, Holger Schroefel6, Matthias Thielmann7, Shahram Lofti8, Christoph Huber9, Andreas Holzamer10, Nicolas Doll11, Klaus Matschke12, Thorsten Wahlers13, Anno Diegeler14, Carlo Savini15, Nalian Schnelle16, Carla Agatiello17, Hermann Reichenspurner18, Friedrich W. Mohr3, Thomas Walther1. 1Kerckhoff Clinic Bad Nauheim, Bad Nauheim, Germany, 2University Heart Center Hamburg, Hamburg, Germany, 3Heart Center University of Leipzig, Leipzig, Germany, 4Heart Center Bad Rothenfelde, Bad Rothenfelde, Germany, 5Clinic for Cardiac Surgery Bad Berka, Bad Berka, Germany, 6Clinic for Cardiac Surgery Karlsruhe, Karlsruhe, Germany, 7West German Heart Center University of Essen, Essen, Germany, 8University Clinic Aachen, Aachen, Germany, 9University Clinic Bern, Bern, Switzerland, 10University Clinic Regensburg, Regensburg, Germany, 11Sana Clinic Stuttgart, Stuttgart, Germany, 12Heart Center University of Dresden, Dresden, Germany, 13Heart Center, University of Cologne, Cologne, Germany, 14Clinic for Cardiac Surgery Bad Neustadt, Bad Neustadt, Germany, 15University Clinic Bologna, Bologna, Italy, 16University Clinic Mainz, Mainz, Germany, 17Hospital Italiano, Buenos Aires, Argentina, 18Heart Center University of Hamburg, Hamburg, Germany.
Objective: A novel, innovative transapical aortic valve implantation (TA-TAVI) system received CE-mark approval in September 2011 and to date almost 300 commercial implants have been performed. The ACURATE TA device (Symetis, Lausanne, Switzerland) is composed of a self-expanding nitinol stent covered by an anti-PV leak skirt with a surgical quality porcine tissue valve sewn within. Following CE-mark approval of the device, a post-market registry was performed to include the first 250 patients implanted with this new TA-TAVI system. The patients were treated from November 2011 - November 2012.
Methods: The registry was conducted at 17 sites in Germany, Argentina, and Italy to treat 250 high-risk elderly patients suffering from severe symptomatic aortic stenosis. This all-comers population presented pre-operatively with a mean aortic gradient of 43.3 ± 17.4 mmHg and a mean AVA of 0.7 ± 0.2 cm2. The patients were considered high-risk due to advanced age and multiple co-morbidities. Mean age of treated patients was 80.9 ± 6.3 years with a mean STS score of 8.0 ± 5.9% and mean Logistic EuroSCORE I of 22.3 ± 12.7%. The majority of patients (90.8%) presented preoperatively in NYHA Class III/IV and 48.4% are female. All patients were treated within a multi-disciplinary heart team.
Results: The procedural success rate was 98.4% (n=246) with two valve-in-valve procedures and two conversions to conventional surgery. The implantations were performed using small, medium and large bioprostheses covering an annular range of 21 mm to 27 mm. Thirty-day mortality rate was 4.8%. Post-implant echocardiography revealed only two patients with +2 (moderate) paravalvular leak. All other patients (99.2%) demonstrated either none/trace or a 1+ leak only. At 30-days two patients had suffered a stroke (0.8%). The mean gradient was 12.8 ± 5.2mmHg with a mean EOA of 1.4 ± 0.3 cm2. The new pacemaker implantation rate was 4.8% (n=12) and 88% of returning patients presented in NYHA Class I/II.
Conclusions: These real world results using this new TA-TAVI device are promising and compare well to longer approved devices. At ISMICS 2013, the 12-month results from the first 100 patients in the registry will be presented for the first time.
C4 Implant and Short-Term Outcome with the JenaValve, a Second-Generation Self-Expanding Trans-Apical TAVI System: Post CE Mark Single-Center Experience
Devdas T. Inderbitzin1, Florian Rueter1, Raban Jeger2, Christoph Kaiser2, Jens Fassl3, Friedrich S. Eckstein1, Oliver Reuthebuch1. 1Clinic for Cardiac Surgery Basel-Bern, University Hospital Basel, Basel, Switzerland, 2Department of Cardiology, University Hospital Basel, Basel, Switzerland, 3Department of Anesthesiology, University Hospital Basel, Basel, Switzerland.
Objective: We present the first Swiss and post CE-mark implant experience and short-term outcome with the JenaValve TAVI system.
Methods: Patients receiving trans-apical TAVI on beating heart using the JenaValve System (JenaValve Technology GmbH, Munich, Germany) from November 2011 - August 2012 were evaluated. Baseline characteristics, intra- and postoperative course with clinical/echocardiographic evaluation were analyzed. Perioperative complications were defined to Valve Academic Research Consortium criteria.
Results: 27 patients (30% female, mean age 80.3 ± 5.5 years, mean logistic EuroSCORE 23.3 ± 11.7) presented in median NYHA class III (min. II, max. IV), a mean LVEF of 50.5 ± 13.3% and a severe calcified aortic valve stenosis (mean dP 47.5 ± 16.2 mmHg, mean valve opening area: 0.81 ± 0.21 cm2). Mean operation time was 123.7 ± 23.2 minutes (reducing from 122.8 ± 28.8 to 114.0 ± 17.9 min. from first to second half). Implant success rate was 100%, 17 (63%) cases needed intraoperative balloon dilation to correct paravalvular leakage (success rate 70.6%). Used prostheses’ sizes were 23 mm (22.2%), 25 mm (51.8%), 27 mm (26%). In-hospital MACCE: intra-operative resuscitation with aortic rupture (3.7%), postoperative hemorrhage needing revision or drainage (7.4%), myocardial infarction (3.7%), AV-block needing definitive pacemaker (3.7%), new onset renal failure needing hemodialysis (3.7%), pleural empyema (3.7%) and stroke (3.7%). 30-day-mortality was 11.1% (n=3, cardiac). Except one conversion to open surgery due to aortic rupture, no perioperative directly device related complications occurred. Mean ICU/total stay was 2.2 ± 1.7/11.7 ± 7.9 days. Median NYHA class increased to II until discharge (p=0.0001, Wilcoxon signed rank test). Postoperative (day 6.7 ± 4.8) echocardiography revealed residual paravalvular leakage grade 1 in 12 patients (55.5%) and a mean trans-valvular pressure gradient of 11.6 ± 5.6 mmHg with significant reduction by 36.0 ± 17.7 mmHg (p=0.0001, Wilcoxon signed rank test). LVEF did not significantly change (p = 0.769, Wilcoxon signed rank test).
Conclusions: Trans-apical TAVI with the JenaValve was safe with an excellent short-term outcome, a significant reduction of mean pressure gradient, low complication rate and mortality with an overall clinical improvement at discharge. Long-term follow-up has to confirm this favorable tendency.
CMP4 Transventricular Off-Pump Tricuspid Valved Stent Implantation: Approach and Echocardiographic Guidance in an Acute Study
Jan P. Gundlach, Saskia Pokorny, Telse Bähr, Jawid Madjidyar, Huang D. Dai, Martin Marczynski-Bühlow, Jochen Cremer, Georg Lutter. University Hospital Schleswig-Holstein, Campus Kiel, Kiel, Germany.
Objective: A transventricular approach is presented and evaluated for off-pump orthotopic tricuspid valved stent implantation under transesophageal echocardiographic (TEE) guidance.
Methods: A nitinol valved stent was implanted in twelve pigs using a minimally invasive transventricular approach. Access was granted from the exposed right ventricular lateral wall close to the apex through a lower ministernotomy. A custom-made delivery system was used to implant a nitinol valved stent with a super absorbent polymer (SAP) pouch attached for better paravalvular sealing. Positioning of the stent was visualized using two-dimensional and more recently also three-dimensional TEE. Swan-Ganz catheter and echocardiographic measurements were performed before and 1h, 3h and 6h after implantation. Animals were observed for a period of six hours. Positioning of the valved stent and the SAP-pouch was evaluated during gross examination.
Results: Implantation was successfully accomplished at first attempt in eight of twelve cases. Four pigs died of ventricular fibrillation (n=2) or stent migration (n=2) during implantation. TEE evaluation showed none or mild tricuspid valve regurgitation. One hour after implantation mild paravalvular leakage (PVL) was found in one and trace in the remaining animals. No PVLs were detected in two animals at the final evaluation. Eight animals maintained hemodynamic stability during the observation period (Table CMP4-1). The heart rate increased after implantation and remained elevated during the follow-up period. The right ventricular function was stable and the end-diastolic pressure remained low with 3±3mmHg after six hours.
The transventricular approach was well suited for successful implantation of novel tricuspid valved stent into the tricuspid annulus allowing for a large diameter of the delivery system. This enables the use of large stents (≤57mm) and fitting of the SAP sealing pouch necessary for proper sealing within the tricuspid annulus.
Conclusions: The transventricular approach is feasible for minimally invasive off-pump implantation of tricuspid valved stents. It enables secure deployment of the valved stents with good valvular function. Sufficient paravalvular sealing was observed and was accredited to the stent size and adjacent SAP pouch.
CMP5 DA-TAVI (Direct Aorta-Ascending Approach in TAVI)
Gry Dahle, Kjell Arne Rein. Rikshospitalet, OUS, Oslo, Norway.
Objective: Direct aorta-ascending approach is a new access way for TAVI, to be used in patients with peripheral vascular disease and as an alternative to transapical approach.
Methods: Both the Edwards SAPIEN and CoreValve systems were used. Depending on the course of the ascending aorta, the relation to sternum, the brachiocephalic vein, eventually vein grafts, LIMA and RIMA grafts from previous heart surgery, either mini-right thoracotomy or mini L-sternotomy was selected. CT-scan with reconstruction was applied for this decision-making. A hybrid operating room was used with echocardiographic and fluoroscopy guidance.
Results: So far we have done 16 procedures via aorta ascending. Mean age 79 years, 11 males. The mean Logistic EuroSCORE 1 of 37 reflects the comorbidities. Two-thirds of the patients had coronary vessel disease and had undergone CABG; one-third had abdominal aortic aneurysm. Mean EF was 43% and the patients were in NYHA class 3-4. The mean gradient was 45 mmHg and mean valve area was 0.7cm2. Mean valve size was 29 mm. The use of Edwards SAPIEN vs. CoreValve was 9 vs. 7 and thoracotomy vs. sternotomy was 6 vs. 10. All procedures were done successfully, but one patient had a periprocedural valve-in-valve. All but three patients were extubated in the operation room. The patients stayed in the ICU over night. Four patients were reoperated: 1) chest tube to drain fluid, 2) vascular reconstruction following the angio, 3) pacemaker lead perforation and acute operation in ICU, and 4) redo open surgery due to paravalvular leak. The over-all survival was 81% (follow-up 0-14 months).
Conclusion Access design is an important issue in TAVI. When central approach is needed, TAVI-DA is safe. For patients with low ejection fraction, the TAVI-DA is preferred to the TAVI-TA. The cannulation technique of the aorta is well known for cardiothoracic surgeons and the method is feasible both for the Medtronic CoreValve and Edwards SAPIEN valve, either via the right mini thoracotomy or the mini sternotomy in order to obtain the best coaxial alignment. It seems easier to position the bigger valves more precisely via this central approach.
CMP6 Valve-in-Valve Concept: A Single-Center Experience for Redo Aortic Valve Therapy
Philipp Kiefer, David M. Holzhey, Axel Linke, Gerhard Schuler, Joerg Seeburger, Marcel Vollroth, Friedrich W. Mohr. Heart Center Leipzig, Leipzig, Germany.
Objective: We herein present our experience with transapical transcatheter aortic valve-in-valve procedure as an alternative for high-risk redo surgery.
Methods: Our institutional database was retrospectively screened for patients who underwent transapical aortic valve implantation (TA AVI) since March 2007. A total of 18 patients (12 male) were detected to have received a valve-in-valve implantation. Mean age was 77.6 ± 7.3 years and all patients were in New York Heart Association (NYHA) functional class III. The periopeative risk was estimated using log EuroSCORE (26.3 ± 12.2%). Mean follow-up time was 708 days.
Results: In all patients highly calcified and stenotic AV-prostheses were diagnosed (max/mean transvalvular pressure gradient: dPmax 64.7 ± 19.1 mmHg, dPmean 37.1 ± 9.9 mmHg, aortic valve area: 0.8 ± 0.2 cm2). All patients underwent standard TA AVI procedure following the valve-in-valve concept using the Edwards SAPIENS valve with a procedural success of 100%. Early postoperative course was uneventful in all patients. Intra- and postoperative hemodynamic function was highly acceptable (grade of aortic insufficiency: 0.3 ± 0.7 and a dPmax 16.2 ± 11.7 mmHg, dPmean 10.3 ± 6.1 mmHg). Thirty-day mortality was 16.6%. Cause of death was respiratory failure in all three patients.
Conclusions: TA AVI as valve-in-valve was feasible and associated with good perioperative results in this high-risk patient population.
C5 Six-Month Evaluation of the Zero Ischemia Coronary Anastomotic Connector in an Off-Pump Porcine Bypass Model
David Stecher, Gerard Pasterkamp, Lex A. van Herwerden, Marc P. Buijsrogge. University Medical Center Utrecht, Utrecht, Netherlands.
Objective: To facilitate minimal access CABG, a simplified alternative for hand-sutured anastomosis has to be developed. This study evaluated the zero ischemia ELANA (Excimer Laser Assisted Non-occlusive Anastomosis) coronary connector at 6 months in the porcine OPCAB model (equivalent to a 2-year healing response in human coronary arteries) with regard to anastomotic healing, remodeling and hemodynamic function. Initial mid-term results (5 weeks, n=12) in the same model showed that the coronary connector is easy-to-use, feasible and safe, and all anastomoses were fully patent with streamlining neointimal coverage along the circumference of the anastomosis.
Methods: In 2 animals, LITA-to-LAD and in 1 animal, LITA-to-LAD and RITA-to-RCA bypasses were evaluated intraoperatively and at 6 months (n=4; coronary inner diameter [ID] 2.5 mm). The anastomoses (n=4) were examined by angiography, fractional flow reserve (FFR), coronary flow reserve (CFR), flow measurement, scanning electron microscopy (SEM; n=1), histology (n=2), optical coherence tomography (OCT; n=1) and intravascular ultrasound (IVUS; n=1).
Results: All anastomoses (n=4) were fully patent (FitzGibbon grade A) at follow-up with a FFR of 0.88 ± 0.03 and a CFR of 4.3 ± 0.7 (coronary ID 2.5 mm preoperative, 4 mm at 6 months). Intraoperative mean peak hyperemic flow response after 30-second graft occlusion was 4.3 ± 1.3. SEM demonstrated complete endothelial coverage of the anastomotic surface and histology showed minimal intimal hyperplasia at 6 months (Figure C5-1). At follow-up, IVUS and OCT confirmed histologic findings, and OCT measurements demonstrated limited neointimal formation with a 0.06 mm intimal coverage of the intraluminal part of the connector.
Conclusions: The zero ischemia coronary connector showed an excellent healing response on the long-term in the porcine OPCAB model, and hence has potential for minimally invasive CABG. Despite the relatively undersized anastomosis at 6 months due to the growth of the porcine coronaries over 6 months, excellent anastomotic healing and remodeling were demonstrated. Safety and quality of the anastomoses on small caliber coronaries still has to be assessed.
CMP7 A New Suture Device for Distal Coronary Artery Bypass Surgery
Minoru Ono1, Yoshifumi Itoda1, Panthee Nirmal1, Takehiro Ando2, Ichiro Sakuma2. 1The University of Tokyo Hospital, Tokyo, Japan, 2The University of Tokyo, School of Engineering, Tokyo, Japan.
Objective: Traditional hand-sewing and knot-tying have been used for coronary artery bypass grafting (CABG). Although distal suture devices have been applied to facilitate an easier anastomosis in limited cases, such as endoscopic or robotically assisted CABG, almost all these devices were withdrawn from the market for various reasons. We developed a new distal suture device, which allows a continuous suture and eliminates knot-tying. We examined safety, feasibility and durability of this device in animal models.
Methods: This new device comprises a regular 8-0 polypropylene suture attached to a tiny anchor mechanism made up with biocompatible stainless steel at the tail. This patented stainless steel anchor works as a stop mechanism at the start point and as a hooking mechanism at the end of a continuous anastomosis, thus eliminating knot-tying. Stability of anastomosis and tissue invasiveness was tested in a rabbit carotid artery bypass model (acute, 1 month, 3 months and 6 months). Off-pump CABG using bilateral internal thoracic artery model in miniature pigs has been tested for preclinical feasibility study, focusing on quality of anastomosis, inflammatory change induced by the device and biocompatibility (acute, 1 to 6 months). All animals received humane care according to the guidelines of the University of Tokyo.
Results: Rabbits were divided into two groups: the new device and conventional 8-0 polypropylene suture. Suture time was not different between groups. Graft patency rate by angiography after 1 month, 3 months and 6 months was favorable and identical between two groups. Histopathologic examination revealed only mild inflammatory responses at the anastomotic sites in both groups without any specific inflammatory change derived from the device. Pigs were divided into two groups as in rabbit models. There were no difference in suture times, graft flow, and patency rates in acute and late phases up to 3 months between groups.
Conclusions: Safety, feasibility and durability of this new anastomotic device were shown in animal models. This device may be a promising distal suture device for CABG in endoscopic and robotic assistance as well as a regular open situation.
C6 The Accuracy of Transit Time Flow Measurement in Predicting Graft Patency After Coronary Artery Bypass Grafting
William T. Daniel, Henry A. Liberman, Chandan Devireddy, John D. Puskas, Vinod H. Thourani, Michael E. Halkos. Emory University School of Medicine, Atlanta, GA USA.
Objective: Transit time flow measurement (TTFM) is a method used to assess intraoperative blood flow after coronary anastomoses. Angiography remains the gold standard for the assessment of graft quality and flows after coronary artery bypass surgery (CABG). The purpose of this study was to compare flow assessments using TTFM using the Medistim probes and the VeriQ Flowmeter System (Medistim, ASA, Oslo, Norway) with diagnostic angiography.
Methods: From August 1, 2010 to April 30, 2012, 200 patients underwent robotic-assisted CABG procedures. Of these, 160 patients had both TTFM and either intraoperative or postoperative angiography performed of the left internal mammary artery to left anterior descending coronary artery graft. TTFM measurements were obtained after completion of the anastomosis and after administration of protamine prior to chest closure. TTFM assessment included pulsatility index (PI), diastolic fraction (DF), and flow (ml/min). Angiograms were graded according to Fitzgibbon criteria as Fitzgibbon A, B, or O. Patients were grouped according to angiographic findings with patent grafts defined as FitzGibbon A and non-patent grafts defined as either Fitzgibbon B or O.
Results: The mean age was 62.4±11.6 years and 114 (71.3%) patients were male. Overall, there were 152/160 (95.0%) angiographically patent grafts (FitzGibbon A). Of the 8 non-patent grafts, 4 were occluded (Fitzgibbon O) and 4 had significant flow-limiting lesions (FitzGibbon B). Three patients had graft revision after intraoperative angiography. One had redo CABG during the same hospitalization, and 4 were treated with percutaneous intervention. TTFM revealed no significant differences between patent grafts and non-patent grafts in PI (1.98±0.76 vs. 1.65±0.48, p=0.23), DF (73.5±8.45 vs. 70.9±6.15, p=0.39) or flows (34.3±16.8cc vs. 23.9±12.5cc, p=0.09).
Conclusions: Although TTFM can be a useful tool for graft assessment after CABG, false negatives can occur. Angiography remains the gold standard to assess graft patency and quality of the anastomosis after CABG. For innovative revascularization strategies such as robotic-assisted CABG, angiographic assessment may be helpful during the surgeon’s early experience.
C7 Results of Endoscopic Radial Artery Harvesting in 1,577 Patients
Kamellia Dimitrova, Gabriela Dincheva, Helbert DeCastro, Darryl Hoffman, Charles Geller, Robert Tranbaugh. Beth Israel Medical Center, New York, NY USA.
Objective: We reviewed 1,577 consecutive patients undergoing coronary artery bypass grafting (CABG) using endoscopic harvesting of the radial artery (RA) to define our current results.
Methods: Since 2000, we have performed endoscopic radial artery harvest on 1,577 consecutive patients; 1,476 patients had isolated, primary CABG and 101 patients had CABG and valve replacement or repair procedures. Average age was 59.4±9.0 years, 80.2% were male and 40% had diabetes mellitus. All data was prospectively collected. All cause mortality was determined using the Social Security Death Index.
Results: There were 9 in-hospital or 30-day deaths for an overall unadjusted operative mortality of 0.57%: mortality was 0.34% in isolated CABG and 3.85% in CABG/valve procedures. The overall estimated Kaplan Meier survival at 1, 5 and 10 years was 99%, 95% and 88%. In 37 other patients, the radial arteries were not harvested or were not used for grafting because of a positive Allen test, extensive calcification or dissection, intramural hematoma and scarring from previous arterial lines or catheterization. The conduit length was consistent between 20 and 25 cm and was used primarily to bypass the left circumflex coronary system. Six percent of patients had both radial arteries harvested endoscopically and another 17.3% of patients had sequential or radial Y-grafts resulting in an average of 3.9 grafts per patient and an average of 2.5 arterial grafts per patient. During postoperative follow-up, 5 patients (0.32%) were treated for incisional infection and there were no ischemic hand complications. Three patients had a perioperative myocardial infarction in the radial artery graft distribution and 15 patients had a coronary artery reintervention in the radial artery graft distribution. Two other patients had a PCI of their RAs. The overall RA patency at 10 years was 82%.
Conclusions: Endoscopic harvest of the RA is an excellent minimally invasive conduit harvesting technique with outstanding outcomes with minimal morbidity.
CMP8 Influence of Endoscopic Harvesting on Radial Artery Graft Quality
Mani Arsalan, Anke Gitschmann, Johannes Blumenstein, Arnaud Van Linden, Sebastian Szardien, Helge Möllmann, Thomas Walther, Jörg Kempfert. Kerckhoff Clinic, Bad Nauheim, Germany.
Objective: Several studies showed an improved patient satisfaction combined with less wound healing disturbances after endoscopic radial artery harvesting. Despite these findings endoscopic harvesting is, especially outside the USA, still not standard of care. Concerns regarding graft quality after endoscopic harvesting are the main reason against the minimal invasive technique.
Methods: In this randomized trial we investigated radial artery quality after endoscopic or conventional surgical graft harvesting in patients (n=50) undergoing coronary artery bypass grafting. The endoscopic harvesting was performed using the Storz Endovein retractor (Karl Storz, Tuttlingen, Germany) combined with the Starion STLS device (Starion Instruments, Sunnyvale, CA USA). After harvesting, the proximal part of the radial artery was histologically examined using different endothelial markers (CD31, eNOS, VCAM and ICAM) to investigate endothelial integrity.
Results: We could not detect a significant difference in graft quality between the two harvesting techniques. There were no differences regarding the rate of transmural or intimal injuries.
Conclusions: Consequently, based on the 2005 ISMICS consensus statement and our findings, showing that endoscopic harvesting does not influence graft quality, radial artery harvesting should be performed endoscopically as standard of care.
CMP9 Endoscopic versus Conventional Harvesting of the Radial Artery in Coronary Artery Bypass Grafting: A Prospective Randomized Control Trial
Bob Kiaii, Stuart Swinamer, Stephanie Fox, Larry Stitt, MacKenzie Quantz, Michael Chu, Ray Guo, Richard Novick. London Health Sciences Center, London, ON Canada.
Objective: Our objectives were (1) to determine if minimally invasive endoscopic harvesting of the radial artery reduces morbidity due to pain, infection, and disability with improvement in satisfaction and cosmesis compared to the conventional technique and (2) to compare the 6-month angiographic patency of the radial artery harvested conventionally and endoscopically.
Methods: In a prospective study, 119 patients undergoing coronary artery bypass grafting using the radial artery were randomized to have radial artery harvested either using conventional method (n=59) or endoscopic minimally invasive method (n=60).
Results: Radial artery harvest time (open wound time) was significantly reduced in the endoscopic group (36.5 ± 9.4 vs. 57.7 ± 9.4 minutes, p< .001). Only one patient developed wound infection (1.6%) in the endoscopic group compared to 6 patients (10.2%), p=.061, in the conventional group. Although this was not statistically significant, clinically this was relevant in terms of reduction in postoperative morbidity. Postoperative pain in the arm incision was significantly lower in the endoscopic group at postoperative day 2 (p<.001) and at discharge (p<.001) and similar to the conventional open group at 6-week follow-up (p=.103). Overall patient satisfaction and cosmesis were significantly better in the endoscopic group at postoperative day 2 (p<.001), at discharge (p<.001), and at 6-week follow-up (p<.001). There was no difference in the arm disability postoperatively based on the DASH (Disabilities of the Arm, Shoulder and Hand) score (p= .505) between the endoscopic and conventional harvesting group. Six-month angiographic assessment of 23 patients (12 endoscopic and 11 open conventional) revealed no difference in the number of patent radial arteries (10/12 in endoscopic and 9/11 in open conventional group).
Conclusions: Endoscopic radial artery harvesting significantly reduced postoperative wound pain, improved patient satisfaction and cosmesis, and also reduced the incidence of wound infection compared to conventional harvesting technique. There was no difference in the 6-month angiographic patency of the radial artery harvested conventionally and endoscopically.
CMP10 Early- and Mid-Term Outcomes of Endoscopic versus Open Radial Artery Harvesting: A Case-Match Study
Gianluigi Bisleri1, Laura Giroletti1, Bruno Guarneri2, Faisal H Cheema3, Claudio Muneretto1. 1Division of Cardiac Surgery, University of Brescia Medical School, Brescia, Italy, 2Section of Neurophysiopathology, Spedali Civili di Brescia, Brescia, Italy, 3Division of Cardiothoracic Surgery, Columbia College of Physicians & Surgeons, New York, NY USA.
Objective: During the past decade there has been a steady evolution of endoscopic radial artery harvesting (ERAH) techniques as an alternative to the conventional approach in order to increase patients’ satisfaction while reducing pain and wound complications. Nevertheless, the comparison of outcomes either at short- and mid-term have been debatable to date.
Methods: From January 2003 to December 2012, 325 patients underwent CABG at least with a RA conduit: 106 patients were matched according to parameters such as age, sex, diabetes, peripheral artery disease, number of diseased coronary vessels and target anastomotic site (for RA) and assigned either to Group 1 (G1, open, n=53) or Group 2 (G2, endoscopic, n=53) according to the harvesting technique. Endoscopic harvesting was performed via a reusable retractor and a vessel-sealing system. Early- and mid-term outcomes were assessed in terms of hand/forearm sensory discomfort (including pain assessment - VAS score, paresthesia and dysesthesia) forearm wound problems (Hollander scale), and RA patency rates. Moreover, electroneuromyography (ENM) was performed in ERAH group to evaluate radial nerve sensory conductions at the harvest site in terms of velocity (SCV), amplitude and latency of sensory nerve action potentials (SNAPs).
Results: No conversion occurred to the open technique in G2. No patients in either group showed hand ischemia; wound infection occurred only in the open group (G1=5% vs. G2=0%, p=NS). Wound healing (Hollander scale) was considerably better in the endoscopic group (G1=3.95 vs. G2=4.87, p<0.001) as well as neurological (sensory) complications, also at the latest follow-up (G1=10% vs. G2=2.5%, p<0.001). Pain (VAS score) was significantly reduced with the endoscopic technique (p<0.05). ENM confirmed normal function of the radial nerve in term of SCV (52 ± 3.8 m/sec), amplitude of SNAPs (11.9 ± 2.7 m/s) and latency of SNAPs (1.9 ±0.3m/s). At the latest follow-up (mean=4.2 yrs), clinical outcomes (angina, CCS class) were similar among the groups with only 1 occluded RA in the open group versus none in the endoscopic one (p=NS).
Conclusions: Endoscopic radial artery harvesting allows for improved early- and mid-term outcomes in terms of improved cosmesis, reduced wound and neurological complications without jeopardizing the integrity of the conduit.
CV1 Endoscopic Radial Artery Harvesting: A Versatile Technique Without CO2 Insufflation and Combining a Reusable Retractor With Different Vessel Sealing Systems
Gianluigi Bisleri, Claudio Muneretto. University of Brescia Medical School, Brescia, Italy.
Objective: The preferred approach for endoscopic radial artery harvesting (ERAH) to date has been based on the use of sealed systems, which may potentially jeopardize the quality of conduit. We therefore sought to investigate the feasibility of a different, simplified minimally invasive radial artery harvesting approach combining a novel resterilizable retractor with different vessel sealing systems.
Methods: Seventy-two (72) patients underwent ERAH combining a dedicated stainless steel resterilizable retractor with two different vessel sealing systems: in 35 patients, a bipolar radiofrequency (BR) device with nanoscale control system and tissue-dynamic energy delivery was utilized, while in the remaining 37 patients a BR device with sensing technology allowing for analysis in tissue impedance and adjusting energy output accordingly; both devices allows for sequential sealing and tissue division and are FDA-approved for vessel sealing up to 7 mm. A 2 cm longitudinal incision of the forearm is performed at the wrist crease; the distal part of the radial artery is dissected under direct vision by means of the vessel sealing system. Once enough space is created, the endoscopic retractor is advanced towards the antecubital fossa while fascial division is carried out. A careful dissection around the pedicled radial artery is then performed by means of the vessel sealing systems. Neither CO2 insufflation nor any arm tourniquet is utilized.
Results: Mean harvest time was 23±12 min. No bleeding requiring conversion to the open technique was observed during all procedures. No additional clipping was required. The radial artery could be harvested full length without any macroscopic damage in terms of tissutal charring or sticking. No macroscopic spasm of the radial artery occurred. No complications, either in terms of wound problems, hematomas, or neurological impairment occurred.
Conclusions: ERAH can be safely and effectively performed combining a reusable retractor and different models of vessel sealing systems. This versatile and cost-effective approach avoids the drawbacks and potential complications associated with the use of sealed systems and active CO2 insufflation.
CMP11 Simultaneous Bilateral Mini-Thoracotomies: A Logical Next Step to Sternal-Sparing Open Heart Surgery
Prem Rabindranauth1, Kara J. Kallies2. 1Gundersen Lutheran Health System, La Crosse, WI USA, 2Gundersen Lutheran Medical Foundation, La Crosse, WI USA.
Objective: Advances in minimally invasive techniques in cardiac surgery promise to greatly improve clinical outcomes. Although the literature is rife with reports of robotic and mini-valve surgery, experiences with minimally invasive coronary artery bypass grafting (MICS-CABG) via a left mini-thoracotomy have only recently been reported. To date there are no reports of simultaneous sternal-sparing, bilateral thoracotomies combining revascularization with valve repair or other cardiac procedures.
Methods: We report 5 consecutive cases in which bilateral 5-cm mini-thoracotomies were used concurrently to perform a MICS-CABG and either mitral valve repair (MVR) or radiofrequency ablation (RFA) with left atrial appendage amputation from January 2011 through September 2012. All portions of the MICS-CABG operations were done via a left mini-thoracotomy. MVRs were done via a right mini-thoracotomy with femoral cutdown for cardiopulmonary bypass and RFAs were done via bilateral incisions.
Results: Three patients underwent MICS-CABG+MVR, and 2 underwent MICS-CABG+RFA (Table CMP11-1). All 5 patients were men. Of the 3 patients who underwent CABG+MVR, 1 had a single-vessel bypass, and 2 had double-vessel. Both patients who underwent CABG+RFA had double-vessel bypass. Cardiopulmonary bypass was used only in the MVR cases, and all patients received mechanical ventilation for less than 24 hours after surgery. There were no mortalities or significant complications. One patient required a transfusion after 2-vessel MICS-CABG+MVR and one patient was readmitted within 30 days after 2-vessel MICS-CABG+RFA for a pericardial effusion requiring pericardiocentesis.
Conclusions: A simultaneous bilateral mini-thoracotomy appears to be well-tolerated in select patients and may be the logical next step in sternal-sparing minimally invasive open heart surgery.
C8 Minimally Invasive Surgical Ablation versus Catheter Ablation for Lone Atrial Fibrillation: Results from the STANDARD Study
Giuseppe Nasso1, Vito Romano1, Mario Siro Brigiani1, Raffaele Bonifazi1, Francesco Bartolomucci2, Giuseppe Speziale1. 1Division of Cardiac Surgery, Anthea Hospital, GVM Hospitals of Care and Research, Bari, Italy, 2Division of Cardiology, “L. Bonomo” Hospital, Andria, Italy.
Objective: To compare the clinical and instrumental results of catheter ablation (CA) vs. those of the minimally invasive, epicardial surgical ablation (SA) in the treatment of isolated atrial fibrillation (AF).
Methods: We reviewed the records of patients who underwent either SA or CA in the 2008-2012 period. After propensity-matching, we obtained two groups of 202 patients each. A longitudinal follow-up was performed.
Results: There was no periprocedural mortality in both groups. The rate of periprocedural morbidity was comparable among the groups (2.5%). At the follow-up (average 36 ± 11 months), one major difference emerged among groups in the rate of recurrence of AF, which was 10.9% in the SA Group vs. 30.2% in the CA Group, p<0.001), irrespective to the preoperative type of AF (paroxysmal or persisting). The survival free from the composite endpoint (including recurrent symptoms of atrial tachyarrhythmia, thromboembolic events, new ablation procedure, cardioversion and new hospitalization for atrial tachyarrhythmia) was significantly lower in the CA Group (p<0.001, Kaplan-Meier analysis). Persisting type of AF, increased preoperative left atrial dimension and obesity independently predicted the recurrence of AF in both the study groups. Nonetheless, the outcome of patients in the SA Group was not affected by the duration of AF history (Kaplan-Meier analysis).
Conclusions: Both the treatment strategies under investigation (CA and SA) met the safety endpoint in the treatment of lone AF. Nevertheless, the surgical ablation appears to yield better results at mid-term follow-up in terms of arrhythmia recurrence, particularly in selected cases having paroxysmal AF and longer history of AF.
CMP12 Mid-Term Results of the Minimally Invasive Surgical Ablation of Persistent and Permanent Atrial Fibrillation
Martin Michel, Stepan Cerny, Jozef Petrus, Jan Petrů, Petr Neužil. Na Homolce Hospital, Prague, Czech Republic.
Objective: In the field of persistent and permanent atrial fibrillation (AF) the results of catheter ablation are less satisfying. Very good results have been recently published with the surgical ablation using cryoenergy and limited incisions.
Methods: We performed prospective nonrandomized single-center study of consecutive patients with symptomatic persistent or permanent AF undergoing mini-invasive surgical ablation procedure. The procedure consisted of endocardial cryoablation of left or both atria and left atrial appendage occlusion via right small anterolateral thoracotomy using full cardiopulmonary bypass and cardioplegic cardiac arrest.
Results: Between July 2008 and October 2011 we performed 30 surgical ablations of AF. It concerned 28 males and 2 females with the average age of 57.9 ± 7.5 years (range 46-76 years). The average duration of arrhythmia before the surgical intervention was 85.58 ± 85.41 months (range 9 - 432). None of the patients have died. The average period of follow-up was 36.2± 8.9 months (12-51 months). During the latest clinical control 86% of patients (25/29) have had stable sinus rhythm (SR) which has been verified by 7-days Holter ECG monitoring. The follow-up limit of 36 months has been completed by 17 patients out of which 15 (88%) have had SR. In 92% patients with SR good mechanical function of the left atrium was detected by transthoracic echocardiography (TTE). Significant reduction of the left atrial diameter comparing to the preoperative size was also detected by the TTE 49 ± 4.6 vs. 45 ± 4.8 (p<0.001). CT angiography of the heart has proven a complete closure of left atrial appendage in all of the patients. During the follow-up none of the patients has suffered a stroke. The NYHA class was improved significantly comparing to the preoperative status 2±0.6 vs. 1±0.5 (p<0.001).
Conclusions: The 88% success rate at 36 months confirmed by long-term monitoring is far better than any results published with the catheter ablation of chronic AF. This technique thanks to its radicality has the potential to substitute the catheter ablation, mainly within the population of younger patients with low surgical risks.
C9 Endoscopic Epicardial Radiofrequency Ablation of Lone Atrial Fibrillation in 105 Patients: 3-Year Results
Timo Weimar, Martina Vosseler, Markus Czesla, Vladimir Voth, Wolfgang Hemmer, Nicolas Doll. Sana Cardiac Surgery Stuttgart, Stuttgart, Germany.
Objective: Catheter ablation has been the preferred choice of treatment for many patients with symptomatic atrial fibrillation (AF). However, incomplete ablation lines and varying success rates remain a problem, especially in patients with persistent AF. We report the efficacy of an endoscopic approach to perform a left-atrial lesion-set on the beating heart.
Methods: Between 2009 and 2012, epicardial bipolar radiofrequency ablation was performed via a bilateral endoscopic approach on 105 consecutive patients with lone AF (mean age: 60±11 years, 71% male). The pulmonary veins (PVI) and the posterior left-atrial wall were isolated using a clamp and a linear ablation device, respectively. A trigonal-line was added connecting the right PVI to the aortic non-coronary sinus. The left-atrial appendage was resected using a stapling-device. Bi-directional conductance block was confirmed for all lesions. Data were collected prospectively. Electrocardiograms, 24-hour Holter or pacemaker interrogation was obtained at 6 and 12 months and annually thereafter. 92% of patients received prolonged monitoring. Late recurrence was defined as any episode of AF, atrial flutter or atrial tachycardia lasting longer than 30 seconds. Quality-of-life was assessed by the SF-36 Health-Survey.
Results: Mean follow-up was 14.3±7.8 months and 97% complete. Mean duration of AF was 6.4±5.7 years with 30% paroxysmal, 24% persistent and 37% long-standing persistent AF. 25% of patients had previously failed a mean of 2.1±1.0 catheter ablations, 9% had experienced thromboembolic events. Median procedure-time was 169 minutes (range: 95-355). There was no death, no conversion to sternotomy and no early or late stroke. Endoscopic re-exploration for bleeding occurred in one patient (1%). Freedom from AF was 87%, 89%, 92% and 80% at 0.5, 1, 2 and 3 years, respectively. Freedom from both AF and antiarrhythmic drugs was 73%, 78%, 88% and 80% at 0.5, 1, 2 and 3 years, respectively. Quality-of-life improved significantly in all physical and mental domains. Left-atrial size and body-mass-index were the only predictors for failure. Type and duration of AF were not predictive for recurrent AF.
Conclusions: Endoscopic ablation can be performed safely with good success rates and might develop to a better alternative to catheter ablation in the treatment of persistent AF.
C10 The Double-Isolation Procedure Provides Superior Outcomes than the Box Lesion Set in Patients with Persistent AF
Claudio Muneretto, Gianluigi Bisleri, Fabrizio Rosati, Luca Bontempi, Antonio Curnis. University of Brescia Medical School, Brescia, Italy.
Objective: The box lesion set has proved to be an effective ablation pattern in paroxysmal atrial fibrillation (AF), albeit a more extensive lesion set may be required in patients with persistent AF in order to further reduce the risk of potential reentrant circuits.
Methods: Fifty-one (51) patients with persistent stand-lone atrial fibrillation underwent a surgical, closed-chest pulmonary veins isolation. In thirty-one patients (Group A, N=31) the ablation was performed by means of a “box” lesion set in the left atrium and additional lines in right atrium (Figure C10-1: intercaval line, line from the transverse sinus and from the oblique sinus to the RAA); in the remaining patients (Group B, n=20) only the box lesion was performed. No significant differences were observed between the two groups in terms of age (Group A=64.4±10 vs. Group B=63.4±9.4 years, p=NS), median AF duration (Group A=35 vs. Group B=39 months, p=NS), LA antero-posterior diameter (Group A=46.9±6 vs. Group B=47±6.3 mm, p=NS). Rhythm outcomes were assessed by means of an implantable loop recorder and Holter monitoring.
Results: The minimally invasive procedures could be completed in either group: in particular, right atrial lesions could be easily added to the box lesion without any intraoperative complications. At a median follow-up of 20 months, sinus rhythm restoration was achieved in 27/31 pts (87.1%) in patients receiving the double isolation procedure while only 60% of patients (12/20) in Group B (box lesion set) were in sinus rhythm.
Conclusions: The double isolation procedure proved to be a safe and feasible technique for persistent AF via a minimally invasive approach. At a median follow-up of 20 months, it was associated with incremental benefits in terms of sinus rhythm restoration compared to the box lesion set alone.
CMP13 Performance of a Novel Bipolar/Monopolar Radiofrequency Ablation Device on the Beating Heart in an Acute Porcine Model
Lindsey L. Saint, Christopher P. Lawrance, Shoichi Okada, Toshinobu Kazui, Jason O. Robertson, Richard B. Schuessler, Ralph J. Damiano, Jr. Division of Cardiothoracic Surgery, Washington University, Saint Louis, MO USA.
Objective: Although the advent of ablation technology has simplified and shortened surgery for atrial fibrillation, only bipolar clamps have reliably been able to create transmural lesions on the beating heart. Currently, there are no devices capable of reliably creating the long linear lesions in the right and left atria needed to perform a Cox-Maze procedure on the beating heart. This study evaluates the performance of a novel suction-assisted radiofrequency device that uses both bipolar and monopolar energy to create lesions from an epicardial approach.
Methods: Six domestic pigs underwent median sternotomy. A dual bipolar/monopolar radiofrequency ablation device was used to create epicardial linear lesions on the superior and inferior vena cavae, right and left atrial free walls, and right and left atrial appendages. The heart was stained with 2,3,5-triphenyl-tetrazolium chloride and each lesion was cross-sectioned at 5 mm intervals. Lesion depth and transmurality were determined.
Results: Transmurality was documented in 94% of all cross-sections (Figure CMP13-1), and 68% of all ablation lines were transmural along their entire length. Tissue thickness was not different between transmural and non-transmural cross-sections (3.1 ± 1.3 and 3.4 ± 2.1, p=0.57, respectively), nor was anatomical location on the heart (p=0.45 for the distribution). Of the cross-sections located at the end of the ablation line, 11% (8/75) were found to be non-transmural, whereas only 4% (8/195) of cross-sections located within the line of ablation were found to be non-transmural (p=0.04). Logistic regression analysis demonstrated that failure of the device to create transmural lesions was associated with low body temperature (p=0.006), but not with cardiac output (p=0.54).
Conclusions: This novel device was able to consistently create transmural epicardial lesions on the beating heart, regardless of anatomical location, cardiac output or tissue thickness. The performance of this device was excellent, and the efficacy approached that of bipolar clamps. Transmurality was lower at the end of the lesions, highlighting the importance of overlapping lines of ablation in the clinical setting.
CMP14 Evaluation of Integrated Bipolar and Unipolar Epicardial Ablation
Andy C. Kiser, Hayden Pappas, Kelly Garner, Anil Gehi, John PaulMounsey. University of North Carolina, Chapel Hill, NC USA.
Objective: Bipolar lesion creation is accepted as the most effective method to create transmural atrial ablations. However, the creation of a comprehensive ablation pattern on the left and right atrium with current bipolar devices is difficult on the beating heart. We evaluate a novel integrated ablation device that creates both bipolar and unipolar lesions in a linear pattern on the beating porcine heart and report initial clinical results.
Methods: Using six porcine models, we evaluated effectiveness of creating beating heart ablation lesions by transmurality and conduction block. Isolating lesions were created on the left and right atria of the beating porcine heart. After bipolar and unipolar lesions were sequentially created, conduction block was confirmed and the lesion depth examined histologically. Additionally, eleven patients with paroxysmal (n=4) or persistent (n=7) atrial fibrillation who failed medical management had subcutaneous monitor implantation and underwent epicardial ablation to isolate the left atrium and right atrial surface with simultaneous endocardial mapping and catheter ablation.
Results: Linear lesions were created successfully on the surface of the beating porcine heart (Figure CMP14-1). Conduction block at 20mV was confirmed at all isolated areas and 96.4% of the lesion sections were full-thickness and transmural at histology. Clinically, the electroanatomic maps of the left atrium confirmed elimination of electrogram voltage amplitude. All patients left the hospital in sinus rhythm without periprocedural stroke, death or major complication.
Conclusions: The new device enables both unipolar and bipolar lesion creation in a linear, low-profile manner, thus enabling effective creation of a comprehensive lesion pattern on the epicardial surface of the beating heart. Initial clinical evaluation demonstrates successful elimination of electrical activity within the epicardial ablation pattern that is augmented by endocardial therapy. Long-term outcomes evaluation is underway.
CMP15 A Novel Dual Energy Ablation Device to Create a Box Lesion for Pulmonary Vein Isolation Using Bipolar and Monopolar RF: Intra Operative Assessment Using a Robotic Approach
Husam H. Balkhy1, Margot Vloka2, Peter Chapman2. 1Medical College of Wisconsin, Milwaukee, WI USA, 2The Wisconsin Heart Hospital, Milwaukee, WI USA.
Objective: Recent trials show that in patients with atrial fibrillation (AF), pulmonary vein isolation (PVI) performed with bipolar surgical ablation clamps using small bilateral thoracotomies is more effective than PVI using standard catheter ablation. This improved efficacy comes with higher invasiveness, difficulty in execution, and potentially more acute complications. Monopolar ‘loop’ devices overcome these drawbacks but at the potential cost of decreased efficacy. Technology that has bipolar effectiveness but with improved access and safety profiles, capable of being deployed endoscopically on a beating heart would be desirable. We evaluated an ablation system that may have all of these characteristics.
Methods: Between April and December 2012, a Box lesion was created with robotic assistance in 17 AF patients using a right-sided unilateral approach with a new suction-applied bipolar ‘loop’ device. The device pulls atrial wall into its cavity and out of the circulating blood to create a bipolar lesion (Figure CMP15-1). Bipolar ablation was applied for 60 seconds at 70°C followed by monopolar ablation for 60 seconds at 70°C. Conduction block testing was performed as well as rapid atrial pacing (RAP) on the PV to induce sustained AF post-ablation. The LAA was occluded via three left-sided 5 mm ports using multiple snares under TEE guidance. The tip of the appendage was incised emptying it of blood.
Results: Four of 17 patients had persistent AF. Eight patients had a staged hybrid ablation. Three patients had concomitant TECAB (totally endoscopic) LIMA-LAD. Average robot time for the AF procedure was 109+14 min. Exit and entrance conduction block was achieved in all patients at a minimum of 5 times threshold. RAP of the PVs was unable to produce sustained AF in 15 of 17 patients. There were no peri-operative deaths or morbidity.
Conclusions: Our initial experience and intra-operative assessment shows that this bipolar epicardial ‘loop’ ablation technology is well designed for easy use in an endoscopic environment and is safe and effective in producing electrical PVI. Clinical and longer-term follow up is warranted.
C11 Implantable Loop Recorders After Atrial Ablation: Patient Compliance and Data Surveillance in Clinical Practice
Friederike Schlingloff, Martin Oberhoffer, Ines Quasdorff, Michael Schmoeckel, Stefan Geidel. Asklepios Klinik St. Georg, Hamburg, Germany.
Objective: Recent data suggest continuous monitoring by implanted loop recorder (ILR) as the “gold standard” for rhythm surveillance after atrial ablation. Studies describing patient compliance and pitfalls in the perioperative period are lacking. The aim of this study was to evaluate patient compliance and physicians’ time invested for obtaining data during the follow-up period after implanting an ILR.
Methods: We prospectively collected data of patients undergoing implantation of an ILR for concomitant cardiac surgery and atrial ablation. Patient compliance was calculated as the ratio of incoming/expected data transmission. We documented physicians’ total time spent with pre- and postoperative explanation of the device and transmission tools, ILR activation, assistance on the phone after discharge, assessment of transmitted data and informing the general practitioner (GP) about results and discussion of treatment modifications.
Results: Between February 2012 and December 2012 a total of 63 patients had an ILR implanted; 44 patients were eligible for evaluating data until first transmission. The ratio of incoming/expected patient data transmission was 7/44 (16%). 36/44 (82%) needed telephone or individual assistance, 1 patient was lost to follow-up. Mean time spent with ILR-related issues during hospital stay averaged 88±19 min. Mean number of necessary telephone calls was 6 ± 4 with an average time consumption of 10±4 min. Assessment of incoming data and information of the patient and GP took 72 min (60-81 min.) per patient. Overall, 220 ± 16 min. on average per patient were needed for appropriate data acquisition, from implantation to first transmission of data.
Conclusions: In patients having an ILR after atrial ablation, compliance regarding data transmission was low. A substantial time effort during hospital-stay and close surveillance during follow-up period are necessary to obtain sufficient data on cardiac rhythm. Patient selection should be handled with care. Beneficial therapeutic decisions can only be expected when reliable data are obtained by efficient management.
C12 An Effective Modification to Simplify the Right Atrial Lesion Set of the Cox CryoMaze
Harold G. Roberts1, Muhammad J. Younus2, Muhammad A. Mehmood2, Robert A. Dickson3, Douglas Seith4, Faisal H. Cheema5, James L. Cox6. 1Holy Cross Hospital - Jim Moran Heart and Vascular Center, Fort Lauderdale, FL USA, 2Aegis Cardiovascular Research Foundation, Fort Lauderdale, FL USA, 3Atricure, West Chester, OH USA, 4Atricure, West Chester, OH USA, 5College of Physicians and Surgeons of Columbia University - New York Presbyterian Hospital, New York, NY USA, 6Washington University in St. Louis, MO USA.
Objective: The reluctance to carry out biatrial Cox-cryomaze for surgical treatment of atrial fibrillation (AF) is primarily to avoid the vexation of creating right atrial lesion (RAL) set of Cox-Maze III. It can be technically challenging, especially when using the robotic approach. Here we demonstrate an alternate set of RAL to simplify this procedure.
Methods: A 69-year-old male presented with NYHA Class-II, EF of 35%, moderately severe MR and long-standing persistent AF. Via a robotic approach, argon-based cryoprobe (2 min/application at -140°C) was used to carry out biatrial Cox-cryomaze in the following manner: first, right-sided cryomaze was done on CPB with a warm, beating heart. The RAL pattern included (i) a horizontal atriotomy that continued medially as linear cryolesion across the posterior tricuspid annulus, (ii) a cavocaval lesion, and (iii) a lateral cryolesion from the mid-portion of atriotomy to the tip of right atrial appendage (RAA). This last lesion was a substitute for cryolesion that, in the past, was directed medially-via a stab wound in the tip of RAA-to anterior tricuspid annulus. Next, under cardioplegic arrest, standard left-sided cryomaze and mitral valvuloplasty (28 mm Physio-II using COR-KNOT) were conducted. The ACC and CPB times were 101 and 185 min., respectively.
Results: Patient was discharged on day 4. At 6-months follow up; he was on no anti-arrhythmic or anticoagulants drugs and Reveal XT loop recorder demonstrated NSR with no AF burden.
Conclusions: Technically deft, the lateral lesion not only avoids potential damage to the AV groove but also is as effective as the medial one in preventing reentrant circuit formation around RAA. The particularly fragile hearts, prone to troublesome bleeding from the medial lesion that results from minor torquing of the still frozen probe, may benefit from this modification. Employing the simplified RAL set, therefore, allows for more easily achieving complete biatrial Cox-cryomaze.
CV2 The “Spacemaker”: A Novel Scopic Approach Facilitating Minimally Invasive Cardiothoracic Surgery
Paul F. Grundeman1, Pieter W. J. Lozekoot2, Gerard Pasterkamp1, Jos G. Maessen2, Paul B. Kwant2. 1Utrecht University Medical Center, The Netherlands, Utrecht, Netherlands, 2Maastricht University Medical Center, The Netherlands, Maastricht, Netherlands.
Objective: Minimally invasive cardiothoracic surgical approaches, like keyhole ablation surgery and left atrial appendix exclusion, currently require CO2-overpressure insufflation and/or alternate left/right-sided single-lung ventilation. These techniques create an oversized surgical corridor which may coincide with a firm drop in blood pressure, depressed cardiac output, over-infusion, shunting, loss of arterial oxygen saturation and prolonged ventilation time which is not well tolerated in the aging frail patient with compromised heart and lung function. We invented an inflatable lung retractor called “Spacemaker” that circumvents homeostatic downsides of traditional space creating methods, and also excludes the use of a double-lumen ventilation tube.
Methods: The retractor was tested in >5 anesthetized pigs (85-100 kg) placed on standard endotracheal ventilation. The “Spacemaker” is constructed out of two sealed sheets of poly-urethane. Packed in deflated condition, the retractor was introduced into the right or the left chest, upon choice of intervention, via an incision of 3×2 cm in the fifth intercostal space and positioned anteriorly of the lung lobes prior to expansion. Two additional 10 mm trocar-ports were placed in the fourth and seventh posterior auxiliary line, respectively, to be used as instrumental ports.
Results: Introduction was easy and unhindered. Under thoracoscopic vision, the “Spacemaker” was inflated up to 0.5 bar thereby pushing the lung tissue gently away cranially, posteriorly and caudally without interfering with diastolic filling of the heart. Blood pressure, cardiac output and oxygen saturation did not change. The “Spacemaker” created an oval-shaped tunnel sizing roughly 5 x 10 cm allowing unhindered feeding and maneuvering of instruments. Different closed chest surgical procedures such as left atrial appendage exclusion, pulmonary vein exposure, pacemaker lead placement and endoscopic stabilization for coronary surgery, were successfully performed in stable hemodynamic and respiratory conditions without damaging tissue or bleedings. Removal was quick and complete in all cases and lung tissue showed no remnant atelectasis.
Conclusions: In the normally ventilated pig, the “Spacemaker” created successfully a surgical corridor for keyhole surgical procedures to the heart, lung and blood vessels without hemodynamic and respiratory compromise. Currently, the “Spacemaker” is prepared for first use in humans.
C13 Papillary Muscles Relocation for Ischemic Mitral Valve Regurgitation: The Role of 3-Dimensional Transesophageal Echocardiography
Khalil Fattouch1, Giuseppe Nasso2, Giuseppe Bianco1, Sebastiano Castrovinci3, Giacomo Murana3, Pietro Dioguardi1, Francesco Guccione1, Giuseppe Speziale2. 1Department of Cardiovascular Surgery, GVM Care and Research, Maria Eleonora Hospital, Palermo, Palermo, Italy, 2Department of Cardiovascular Surgery, GVM Care and Research, Anthea Hospital, Bari, Bari, Italy, 3Department of Cardiovascular Surgery, University of Bologna, Bologna, Italy.
Objective: The assessment of the mitral valve apparatus and its modifications during ischemic mitral regurgitation (IMR) is better revealed by 3-dimensional (3D) transesophageal echocardiography (TEE). To plan mitral valve repair using annuloplasty and papillary muscle (PPM) relocation, we proposed a valve repair procedure oriented by real-time 3D TEE reconstruction of the mitral valve apparatus.
Methods: Since January 2008, we examined 70 patients with severe IMR before mitral valve repair. Mean coaptation depth and mean tenting area were 1.4 ± 0.4 cm and 3.2 ± 0.5 cm2, respectively. Intraoperative 3D TEE was performed, followed by a 3D off-line reconstruction of the mitral valve apparatus. A schematic mitral valve apparatus model was obtained. A geometric model as a truncated cone was traced according to the preoperative data. The size of the prosthetic ring was selected preoperatively according to the anterior leaflet surface. The expected truncated cone after annuloplasty was retraced. A conventional normal coaptation depth about 6 mm was used to detect the new position of the PPM tips (Figure C13-1).
Results: Peri-operative off-line reconstruction of the mitral valve apparatus and respective truncated cone were feasible in all patients. The expected position of the PPM tips desirable to reach a normal tenting area with a coaptation depth of 6 mm or more was obtained in all patients. After surgery, all parameters were calculated and no statistically significant difference was found compared with the expected data.
Conclusions: PPM relocation plus ring annuloplasty reduce mitral valve tenting and may improve mitral valve repair results for patients with severe IMR. This technique may be easily and precisely guided by preoperative off-line 3D echocardiographic mitral valve reconstruction.
CMP16 3D-Echocardiography-Angiography Fusion Technology for Complex Mitral Valve Intervention in the Hybrid Operating Theater
Simon H. Sündermann, Jürg Grünenfelder, Michael Gessat, Patric Biaggi, Christian Felix, Dominique Bettex, Roberto Corti, Volkmar Falk. University Hospital Zurich, Zurich, Switzerland.
Objective: To evaluate the safety of EchoNavigator (Philips Healthcare, Best, Netherlands) during MitraClip (MC, Abbott Vascular Inc. Menlo Park, CA USA) procedures.
Methods: Twenty-one (21) patients were included. EchoNavigator automatically localizes the TEE probe in angiography images to combine real time TEE images with angiography images for adaption of the TEE images to the angulation of the C-arm. Septal puncture side and aimed position of the MC were marked in the TEE by the operator (Figure CMP16-1). All measured parameters were compared to the 21 patients treated directly before the installation of EchoNavigator. Endpoint of this study was safety of the use of EchoNavigator in MC porecuders and its effect at the length of the procedure, length of partial steps and the radiation time and dose.
Results: EchoNavigator could be used without influencing the safety of the intervention. Mean length was 136.2±50.2 min. (67.3±25.2 min/MC if more than one clip was implanted). Mean interval from groin puncture to placement of the first clip was 53.3±14 min., 83.2±27.4 min. to the second clip (17 patients), 134.2±23.2 min. to the third clip (5 patients) and 172.5± 47.4 min. to the forth clip (2 patients). Mean angiography time was 32.3± 16.8 min (11.1±7.2 min./MC). Mean radiation dose was 146.5±123.6 Gy/cm2 (47.8±38.5 Gy/cm2/MC). In the control group a tendency to a reduction of the length of intervention per MC, of partial steps (lengths/MC -8.3 min. (-12%), 1. MC -0.3 min. (-1%), 2. MC -5.5 min. (-7%), 3. MC -75 min. (-56%)) and the radiation dose per MC (-25.9 Gy/cm2, -53%) could be seen but without reaching statistical significance.
Conclusions: EchoNavigator is the first program, which enables fusion of TEE and angiography. Safe use was possible during MitraClip interventions. With the use of EchoNavigator image fusion is done automatically and has not to be performed mentally by the operator. Manipulation of catheters becomes easier and faster by trend. Further studies are necessary to confirm these results.
CMP17 Effective Aortic Annulus Sizing by 3D-CT is Superior to 2D-CT for Reduction of Paravalvular Leaks After Transcatheter Aortic Valve Implantation
Nikolaos Bonaros, Fabian Plank, Guy Friedrich, Thomas Bartel, Silvana Mueller, Anneliese Heinz, Thomas Schachner, Ludwig Mueller, Michael Grimm, Gudrun Feuchtner. Innsbruck Medical University, Innsbruck, Austria.
Objective: The ideal method to define aortic annulus dimensions before transcatheter valve implantation (TAVI) remains a matter of discussion. The aim of our study was to evaluate annulus sizing by 3-D computed tomography for prediction of paravalvular leaks (PL) after TAVI.
Methods: Sixty-nine patients (mean age 83y) with severe aortic stenosis underwent TAVI, transesophageal echocardiography (TEE) and CT and were stratified to two groups according to the presence of PL>0. Two- and three-D annulus diameter and area were measured. Conventional TEE and CT measured AP-diameter were used for valve selection. “Undersizing” was defined as the difference between CT-nominal valve size; “annulus eccentricity” as AP/ML-ratio. PL were detected by echocardiography.
Results: Incidence of PL was: 0:21 (30%), I:32 (46%), I-II:8 (12%), II:5 (7%), II-III:3 (4%), and >III:0. Preoperative TEE measured smaller mean annulus diameters than CT (-2.58 mm, p<0.01). Undersizing occurred in 51% of the valves (no-PL:6/21 (29%) and PL:29/48 (60%)). PL-patients had a higher undersizing grade (1.4 vs. 0.4 mm, p=0.01). The difference of CT-measured annulus area - nominal valve area was higher in PL-patients (1.12cm2 vs. 0.5cm2, p=0.04). Annulus eccentricity index was also higher in the PL-group (0.83 vs.0.79, p=0.01). Application of 3D instead of 2D annulus measurement led to an increase in sensitivity and specificity of 9% and 10% respectively.
Conclusions: Valve undersizing and higher annulus eccentricity are associated with paravalvular leaks after TAVI. 3D annulus sizing by CT may be more accurate than the commonly-used 2D method.
CV3 Impact of Intraoperative Direct Coronary Scanning using 15MHz High Frequency Epicardial Ultrasound
Taiju Watanabe, Hirokuni Arai, Tomohiro Mizuno, Satoru Kawaguchi, Susumu Manabe, Tsuyoshi Hachimaru, Hidehito Kuroki, Tatsuki Fujiwara. Tokyo Medical and Dental University, Tokyo, Japan.
Objective: There is concern about the increased risk of anastomosis construction errors in off-pump coronary artery bypass grafting (OPCAB) because the suturing process is technically more demanding than surgery on the arrested heart. Transit time flow measurement (TTFM) is probably most commonly used in intraoperative evaluation. Unfortunately, flow rate and wave form provided by TTFM are poor indicators of the geometry of anastomosis. Since 2010, we introduced 15MHz high frequency epicardial ultrasound (ECUS) and have been investigating the efficacy of ECUS as intraoperative evaluation in OPCAB surgery. We would like to demonstrate the usefulness of 15MHz high frequency ECUS in this video.
Methods: In OPCAB surgery, we directly scanned the location and the condition of coronary artery before anastomosis. On the basis of these images, we decided optimal anastomosis sites and surgical strategy whether to perform on-lay patch grafting or not. After completion of anastomosis, we evaluated the anastomosis quality using ECUS besides TTFM.
Results: ECUS could provide more detailed information including the depth of coronary artery, and the intraluminal calcified plaque. In case with intra-myocardial coronary artery, we could directly approach the coronary artery avoiding unnecessary dissection or accidental injury of right ventricle. With the precise images of intraluminal calcified plaque, we could make the surgical decision whether to perform on-lay patch grafting or skip anastomosis before dissection of coronary artery. ECUS was also useful to assess the anastomosis geometry immediately after anastomosis. In one case, we could detect intimal flap of internal thoracic artery (ITA) at the anastomosis site and restricted flow pattern with color Doppler flow mapping. We revised the anastomosis with increase in graft flow (10ml/min to 36ml/min).
Conclusions: Next to TTFM, ECUS can easily be employed as a complementary quality control method to provide information about target anastomosis site, bypass graft function and anastomosis geometry. High frequency ECUS was considered an indispensable modality which can improve the quality of OPCAB surgery.
C14 Can Cardiac Surgeons Safely Initiate and Practice Minimally Invasive Coronary Artery Bypass Grafting?
Dai Une, Harry Lapierre, Benjamin Sohmer, Vaneet Rai, Marc Ruel. University of Ottawa Heart Institute, Ottawa, ON Canada.
Objective: Although the safety and efficacy of minimally invasive coronary artery bypass grafting (MICS CABG) have been reported, the procedure is still limited to a few experienced surgeons because specialized techniques are required. This study examined the effects of learning curve on clinical outcomes and operation time in MICS CABG.
Methods: Logistic regression analysis was performed to investigate the relationship between 1-year clinical outcomes (bleeding, myocardial infarction, revascularization, mortality) and the number of MICS CABG performed by a surgeon. Curve regression analysis was performed to assess the correlation between operation time and number of MICS CABG performed. Follow-up beyond the first postoperative year was 100% complete. Also, a cumulative summation (CUSUM) technique was performed to evaluate learning curves.
Results: MICS CABG was performed in 200 consecutive patients by the same surgeon [3 cardiopulmonary bypass (CPB)-assisted single vessel small thoracotomy (SVST), 82 off-pump SVST, 50 CPB-assisted multi-vessel small thoracotomy (MVST) and 65 off-pump MVST]. There was no perioperative mortality, and 5 patients (2.5%) underwent reopening for perioperative bleeding. No complications occurred as a result of CPB assistance. At 1-year follow-up, 1 patient had a myocardial infarction, 1 patient had a percutaneous coronary intervention, and there were 2 non-cardiac deaths. Logistic regression analysis revealed that experience was not associated with adverse events; however, in off-pump SVST and off-pump MVST, experience numbers correlated with operation time (mean duration 124±31 and 241±80 minutes, respectively; R2 = 0.16 and R2=0.38; P<0.001 and P<0.001). Conversely, experience was not associated with operation time in pump-assisted MVST (mean duration 254±42 minutes; R2 < 0.001; P=0.9) (Figure C14-1). By using a CUSUM analysis, the learning period for off-pump MVST to reach optimization was calculated to be 45 cases.
Conclusions: MICS CABG can be safely initiated, with a very low 1-year cardiac event risk. Pump assistance is safe and may be a good strategy to alleviate some of the learning curve when initiating a multi-vessel MICS CABG program.
CMP18 Minimally Invasive Coronary Artery Bypass Grafting is Associated with Improved Clinical Outcomes
Prem Rabindranauth1, Jacob G. Burns2, Todd T. Vessey1, Michelle A. Mathiason2, Kara J. Kallies2, Venki Paramesh1. 1Gundersen Lutheran Health System, La Crosse, WI USA, 2Gundersen Lutheran Medical Foundation, La Crosse, WI USA.
Objective: Minimally invasive coronary artery bypass grafting (MICS-CABG) via left mini-thoracotomy is an acceptable alternative to conventional off-pump coronary artery bypass (OPCAB) surgery via a sternotomy. Our objective was to evaluate the clinical outcomes after MICS-CABG versus OPCAB.
Methods: The medical records of patients who underwent MICS-CABG from December 7, 2009 - December 12, 2011 and OPCAB from January 1, 2005 – April 30, 2011 were reviewed. OPCAB patients were matched 2:1 to MICS-CABG patients by age, sex, preoperative ejection fraction, creatinine, and history of diabetes and myocardial infarction.
Results: 130 consecutive patients who underwent MICS-CABG were matched with 260 patients who underwent OPCAB. Overall, mean age was 66.2 years and 24.6% were female. Mean number of bypasses was 2.1 and 3.2 in the MICS-CABG and OPCAB groups, respectively (P=0.001). Extubation in the operating room (OR) occurred in 70.0% and 12.7% of patients in the MICS-CABG and OPCAB groups, respectively (P=0.001). Mean postoperative length of stay was 4 days in the MICS-CABG versus 5 days in the OPCAB group (P=0.002), and 3.8 days versus 4.6 days for MICS-CABG patients extubated in the OR versus those that remained intubated (P=0.007). There were zero 30-day mortalities in the MICS-CABG group and 1 in the OPCAB group (P=0.999). Thirty-day readmissions rates were similar between the two groups (6.4% and 7.5% in the MICS-CABG and OPCAB groups, respectively; P=0.827).
Conclusions: MICS-CABG is safe, and early clinical outcomes are comparable, if not superior, to OPCAB. Extubation in the OR is feasible, well-tolerated, and was associated with earlier discharge. Shorter hospital stays may decrease resource utilization and promote earlier return to activities; however, further research is needed.
CMP19 Arrested Heart TECAB versus MIDCAB for Revascularization of the Anterior Wall: A Comparative Analysis of Perioperative and Mid-Term Results
Nikolaos Bonaros1, Markus Kofler1, Benedikt Hofauer1, Guy Friedrich1, Johannes Bonatti2, Thomas Schachner1. 1Innsbruck Medical University, Innsbruck, Austria, 2Cleveland Clinic Abu Dhabi, Abu Dhabi, United Arab Emirates.
Objective: The ideal method to place an internal mammary artery (IMA) graft to the anterior wall of the left ventricle remains unclear. Robotics allow totally endoscopic IMA harvesting and either robotically assisted placement of the anastomosis in a totally endoscopic fashion (TECAB) or hand-sewn via mini-thoracotomy (MIDCAB). The aim of the study was to compare both techniques in terms of perioperative and midterm results.
Methods: Robotically assisted arrested heart TECAB was carried out in 195 patients with a median age of 59 (31-77) years and median EuroSCORE I of 1.5 (0-7). Robotic MIDCAB was performed in 43 patients with a median age of 64 (45-82) years and median EuroSCORE I of 2 (0-11). Both techniques were used for single or sequential IMA grafts to the anterior wall. Perioperative results were compared between the groups by Mann-Whitney test for continuous variables and chi square or Fisher’s exact test for categorical variables. Kaplan-Meier plots and log-rank test were used to compare mid-term results.
Results: No perioperative deaths were noted. Surgical difficulties resulting in longer operative times or change in the operative strategy occurred in 60 (30%) of the TECAB and 6 (14%) of the MIDCAB group (p=0.06). Angiographically verified anastomotic stenosis was detected in 6 (3%) and 3 (7%) respectively (p=0.190). Conversions to larger thoracic incisions were needed in 17 (9%) and 3 (7%) respectively (p=0.887). Total operative times were longer in the TECAB vs. the MIDCAB group (291 (175-690) min. vs. 201 (98-510) min.), (p=0.000001). ICU and total length of stay were similar between the groups. Maximum CK levels of 573 (59-11462) mg/dl vs. 301 (193-782) mg/dl (p=0.957) and maximum CK-MB levels of 21 (7-162) mg/dl vs. 17 (9-26) mg/dl (p=0.091) did not differ for the two groups. There was no difference in survival (0 vs. 2% p=ns), freedom from angina (5 vs. 2%, p=0.380) and freedom from MACCE (10 vs. 5%, p=0.270) at a median follow-up of 24 (0-100) months.
Conclusions: Robotically assisted arrested heart TECAB and robotic MIDCAB perform equally in terms of perioperative results and mid-term follow-up in this single-center patient cohort.
C15 Hybrid Approach to Myocardial Revascularization: Early Results of Randomized Trial
Vadim Popov, Kirill Kozyrin, Egor Malyshenko, Vladimir Ganyukov. Research Institute of Complex Issues of Cardiovascular Diseases, Kemerovo, Russian Federation.
Objective: To evaluate early results of prospective RCT HREVS (Hybrid Revascularization Versus Stents).
Methods: The RCT HREVS started at our clinic in April 2012 (http://www.clinicaltrials.gov/ct2/show/NCT01699048). The trial design includes 150 patients, who were divided in 3 groups of 50 patients. Group I is the group of hybrid myocardial revascularization, where the first stage is MIDCAB (LAD-LIMA ) (Figure C15-1) and the second stage is PCI of the remained lesions of coronary arteries. Group II is the group of the conventional CABG. Group III is the group of endovascular revascularization only with the same second generation clinically proven DES. Criteria of inclusion in our trial are multivessel lesions of CA with equal ability to perform all three comparing methods of a revascularization. Randomization is carried out by the blind method (“envelopes”). In hospital time, 24 months and 60 months after primary myocardial revascularization were planned as the control points. As a final point of the trial are accepted death, MACCE, and a repeated revascularization. 45 patients are included in research at this moment. 10, 14 and 21 patients were randomized to the Group I, Group II and Group III respectively. Clinical characteristics of patients in all groups did not differ significantly.
Results: As a first stage in Group I the MIDCAB was performed. Good patency of the grafts was confirmed with flowmetry in the OR and than in the cath-lab. As a second stage the PCI were performed from 1 - 3 days after surgery with good patency of CA and grafts in all cases. In Group II CABG were successfully performed in all cases. There are no unsuccessful or incomplete PCI’s in Group III. There were no mortality and any MACCE, repeated revascularization at in-hospital time in our trial. There are no cases of incomplete myocardial revascularization, technical difficulties and other complications.
Conclusions: The hybrid approach at in-hospital point RCT HREVS demonstrated good results compared with results of traditional approaches for myocardial revascularization.
CMP20 Minimally Invasive Hybrid Revascularization in Patients with Multi-Vessel Coronary Disease: Mid-term Results
Alberto Repossini1, Maurizio Tespili2, Antonio Saino2, Igor Kotelnikov1, Lorenzo Di Bacco1, Claudio Muneretto1. 1university of Brescia Medical School, Brescia, Italy, 2Azienda Ospedaliera Bolognini, Seriate, Italy.
Objective: Hybrid coronary revascularization, meaning left mammary artery on left anterior descending (MIDCAB) combined with non-LAD PCI stenting, is considered as a viable alternative to conventional CABG through sternotomy or to multi-vessel PCI, to perform a functionally complete revascularization. We report our results and mid-term outcomes of this therapeutic strategy.
Methods: Since January 2009 to October 2012, 70 consecutive patients underwent hybrid revascularization after Heart Team evaluation. Demographic, pre-operative, intra-operative data and post-operative outcomes were obtained. Coronary risk was assessed by SYNTAX score, and patients were partitioned in tertiles according to the score categories (≤22 low risk, >22 and ≤33 intermediate risk, >33 high risk). Pre-operative risk assessment was upgraded to EuroSCORE II for all patients. Long-term outcomes, major adverse cardiac and cerebrovascular events (MACCE) rate and repeated target vessels revascularization (TVR) rate were evaluated by Kaplan-Meier curve and log-rank test.
Results: Mean age was 66.3 ± 12.0 years and 83.8% of patients were males. Mean SYNTAX score was 28.22 ± 7 (mean SYNTAX score in patients with left main involved 33.5 ± 4.5). Mean EuroSCORE II was 4.05 ± 1.83. PCI was performed in all patients (n=70), in 52 pts (75.2%) before MIDCAB and in 24.8% of cases after surgery (interval 2.2 ± 1.3 months). In 12 patients (18.6%). No intra-operative or in-hospital deaths were reported. At follow-up one cardiac death for acute inferior myocardial infarction occurred. At 25 ± 13 months follow-up the overall population freedom from MACCEs rate was 82.6% (CI: 79.5% to 85.7%) and the freedom from TVRs rate was 86.1% (CI: 82.9% to 89.3%). Despite the rate of MACCE and TVR was higher in patients with intermediate and high coronary risk than in patients with SYNTAX score ≤ 22, such difference was not statistically significant (p > 0.05).
Conclusions: Hybrid coronary revascularization is a viable option to perform a minimally invasive functionally complete revascularization not only in high-risk patients that can’t undergo conventional revascularization. However, this strategy has better results when performed on patients with a SYNTAX score ≤ 22.
CMP21 Off-Pump Hybrid Coronary Revascularization Technique: Single-Centre Ten-Year Results
Marie Aymami1, Erwan Flécher1, Olivier Fouquet2, Thierry Langanay1, Jean-Philippe Verhoye1, Hervé Lebreton3, Alain Leguerrier1, Hervé Corbineau1. 1Chirurgie Cardiothoracique, Rennes, France, 2Chirurgie Cardiothoracique, Angers, France, 3Cardiologie Interventionnelle, Rennes, France.
Objective: To assess the results of hybrid coronary revascularization: single-centre ten-year experience.
Methods: Between January 2000 and September 2010, 106 consecutive patients underwent combined coronary revascularization, either the same day (n=20), or within 90 days. We defined 3 groups: combined revascularization the same day than surgery (n=20), Group A; percutaneous revascularization in acute coronary syndrome before subsequent surgery (n=39), Group B; and percutaneous revascularization for stable coronary artery disease performed in the same procedure than the diagnostic coronary angiography and subsequent surgery (n=47), Group C. The day before surgery, control coronary angiography was realized for patients in Groups B and C. It was not performed in absence of indication of revascularization of the dilated vessel (myocardial infarction or poor distal run-off). Surgery was performed with the off-pump technique in all cases. Mean follow-up was 6.1±2.7 years in 96.2% of patients.
Results: 107 angioplasties were realized (drug-eluting stents: 21, bare metal stents: 114, balloon angioplasties: 4). Control angiographies were realized for 42 patients. In-stent restenosis were noticed in 7 patients in which 3 required surgical revascularization. Mean number of surgical revascularized coronary arteries was 1.9±0.6, among them 1.8±0.7 with arterial grafts. 93 patients (87.7%) underwent exclusive arterial revascularization. There was 1 reexploration for bleeding (Group A) and no in-hospital death. 11 patients died in the follow-up (4, 2, 5 in Groups A, B and C respectively). Repeat chest pain occurred in 11 patients (3, 3, 5 in Groups A, B and C respectively), acute coronary syndrome in 1 patient (Group B), and myocardial infarction in 2 patients. Repeat PCI was necessary for 6 patients, and repeat surgery for 1 patient (Group B). Freedom from ischemic events (all-causes deaths, angina, acute coronary syndrome, myocardial infarction) was 85.3±3.8% at 5 years and 71.6±6.4% at 10 years (no difference between groups). Freedom from major adverse cardiac or cerebrovascular event (MACCE) was 87.3±3.6% at 5 years and 78.4±5.0% at 10 years (no difference between groups).
Conclusions: Hybrid coronary revascularization enables use of increased rate of arterial grafts, with very good long-term outcome. Currently, these excellent results lead us to perform these procedures in a hybrid theater.
CMP22 Ultra Fast-Track Robotic-Assisted Minimally Invasive Coronary Artery Surgical Revascularization
Bob Kiaii, Christopher Harle, Wojciech Dobkowski, Ivan Iglesias, Bernie Mezon, Michael Chu, Kumar Sridhar, Patrick Teefy. London Health Sciences Center, London, ON Canada.
Objective: The advantages of minimally invasive coronary artery bypass grafting (CABG) surgery over conventional CABG include shorter recovery time, overall reduction in morbidity, blood transfusion, greater patient satisfaction, shorter hospital stay, and earlier return to work. In order to explore the opportunities within our practice to improve patient care while at the same time protecting our patients from harm and reducing costs to our financially challenged hospitals, we identified an opportunity to explore the option of bypassing the intensive care unit (ICU) in a highly selected group of patients undergoing minimally invasive coronary artery bypass surgery. This was accomplished through an extensive collaboration between nurses, administrators and physicians alike.
Methods: A collaborative pathway was constructed for selection of suitable patients by the surgeon and anesthesiologists based on the grounds of compatible coronary anatomy for minimally invasive coronary artery revascularization. Secondary factors included minimal systemic co-morbidity.
Results: A total of 40 patients underwent successful fast-track cardiac surgery. There were 32 males and 8 females. All received preoperative spinal injection of 15 mg of bupivacaine and 3 to 5 mcg/kg of preservative free morphine prior to their general anesthesia. All underwent robotic-assisted CABG in the hybrid operating suite. Immediately after, they underwent cardiac catheterization to confirm patency of their graft and simultaneous percutaneous coronary intervention in 5 patients. Simultaneously, their anesthetic and neuromuscular blockade was reversed achieving spontaneous respiration. The endotracheal tube was removed, and transferred to the post anesthetic care unit (PACU). All patients were monitored in the PACU for 4 hours and transferred to the postoperative ward. One patient underwent uncomplicated exploration for chest wall bleeding. All patients had patent grafts, no post-operative complications and were extremely satisfied on discharge. Average length of stay in hospital was 3.1 ± 0.78 days.
Conclusions: Ultra fast-track cardiac surgery is a safe and efficient way to conduct cardiac surgery in a highly selected group of patients. The importance of collaboration and a team-based approach cannot be emphasized enough. We anticipate expanding this program within our own institution and look forward to evaluating the cost effectiveness of avoiding the ICU.
CMP23 The Impact of Preoperative Clopidogrel Therapy on Postoperative Bleeding after Robotic-Assisted Coronary Artery Bypass Surgery
William T. Daniel, Henry A. Liberman, John D. Puskas, Chandan Devireddy, Wissam Jaber, Robert A. Guyton, Michael E. Halkos. Emory University, Atlanta, GA USA.
Objective: Current guidelines recommend a 5-day waiting period prior to coronary artery bypass surgery (CABG) for patients on clopidogrel (CL). The purpose of this study was to determine if patients undergoing robotic-assisted CABG on CL had an increased risk of bleeding complications compared to those not on CL.
Methods: In an intent to treat analysis from 2008-2011, 322 patients underwent off-pump, sternal-sparing, robotic-assisted CABG via a 3-4 cm anterolateral thoracotomy either as an isolated robotic-assisted CABG or as part of a hybrid revascularization procedure. Patients were classified according to whether they received CL within 5 days of the procedure (CL, N=54) compared to those who never received or who had discontinued CL therapy >5 days prior to surgery (No CL, N=268). A propensity analysis using 31 preoperative variables was used to control for selection bias. In a subgroup analysis, patients undergoing simultaneous hybrid procedures (CL load 600 mg in OR prior to stenting) were analyzed separately and compared to patients in the CL group. Multiple regression analysis was used to control for the propensity score on outcome variables.
Results: In the CL group, the mean interval between surgery and last dose of CL was 2.1±1.5 days. Compared to the no-CL group, the CL group had more 24 hour chest tube drainage (961±584ml vs. 800±533ml, p=0.02) and more blood product transfusions (40.7%, 22/54 patients vs. 20.5%, 55/268 patients, p=0.002). On logistic regression analysis, there was a trend towards higher 24-hour chest tube drainage in the CL group (+161ml, p=0.06) and a significantly higher incidence of blood transfusion (OR=2.21, p=0.02). There was no difference in re-exploration, hospital mortality, ventilator time, or intensive care or hospital length of stay between groups. In the subgroup analysis, patients undergoing simultaneous hybrid procedures (n=17) had more 24-hour chest tube drainage compared to other patients in the CL group (1262 vs. 909ml, p=0.03).
Conclusions: Patients undergoing robotic-assisted CABG on CL had more postoperative bleeding and a higher incidence of blood transfusions. Therefore, these procedures should be performed without clopidogrel when possible.
C16 Per-Ventricular Closure of Perimembranous Ventricular Septal Defect in Pediatric Patient: Long-Term Result
Qi An, Da Zhu. West China Hospital of Sichuan University, Chengdu, China.
Objective: Perventricular closure of pm-VSD is a novel technique which has been reported in the literature; however, follow-up data is still limited. We sought to analyze safety, efficacy and long-term follow-up results of perventricular closure of pm-VSD in selected pediatric patients.
Methods: Between January 2007 and June 2008, 42 pediatric patients underwent per-ventricular closure of pm-VSD at our institution. A domestic made VSD device (concentric or eccentric - SHAMA Corp, Shanghai, China) was used during the procedure. 24-hour Holter EKG as well as echocardiogram was used to detect the complication during hospital stay and follow-up.
Results: Mean age at closure was 3.2 ± 1.0 years (range from 1.5 - 6 years); per-ventricular closure was successfully performed in 34 patients (81%). Among these patients, the mean VSD size was 5.9± 2.7 mm with mean device size 7.3±2.0. No deaths occurred. Total occlusion rate was 82% at completion of the procedure, rising to 91% at discharge and 100% during follow-up. A total of 7 early complications occurred, mainly due to transit device induced aortic (2 patients) and tricuspid valve (4 patients) regurgitation, and transit complete right bundle branch block (CRBBB) (1 patient). The median follow-up time was 4.5 years (range 4 to 5.5). The most significant long-term complication was complete atrioventricular block (c-AVB) which required pacemaker implantation in 1 patient (2.9%). Bundle branch block was also noted in 6 patients (17%) through Holter EKG during follow-up (2-CRBBB, 2 incomplete right bundle block and 2 left posterior fascicular block). Device induced valve regurgitation was noted in 4 patients during follow-up (2 aortic and 2 tricuspid), all in trivial grade.
Conclusions: In the current era and in experienced hands, perventricular closure of pm-VSD can be performed safely in selected pediatric patients with good long-term outcome.
CMP24 Treatment of Isolated Ventricular Septal Defect: Off-Pump Transthoracic Device Occlusion versus Surgical Closure with Cardiopulmonary Bypass
Qin Wu, Quansheng Xing. Children’s Hospital of Qingdao University, Qingdao, China.
Objective: Given the increasing popularity of off-pump transthoracic device closure (OTDC) of ventricular septal defect (VSD) since 2007, a comparative analysis of the different treatments (surgical vs. transthoracic device closure) for VSDs is needed.
Methods: A total of 436 patients with VSDs were randomly divided into two groups: 248 patients treated with OTDC (device group) and 188 patients underwent traditional surgical repair (surgical group). Patients were followed up with the same standard protocol. Clinical, ECG, and echocardiographic data before and after operation were analyzed. Several characteristics (e.g., operating time, complications, blood transfusions, hospital-stay time, cost of hospitalization and complications after operations) were also compared between the two groups.
Results: There were no differences between the two groups according to preoperative baseline characteristics (Table CMP24-1). There was no occurrence of main complications in both two groups during hospital stay and follow-up. Minor complications (such as incomplete right bundle branch block, trace to mild tricuspid regurgitation, hydropericardium, etc.) occurred in both groups. The differences between two groups were shown in Table CMP24-2. The cardiac function was NYHA class I in all subjects.
Conclusions: OTDC of VSD is an effective method which can save many blood products and extracorporeal circulation medical supplies. It can serve as a reasonable alternative treatment with fewer complications and good cosmetic effect for traditional cardiac surgery.
CMP25 Minimally Invasive Transthoracic Device Closure of Ventricular Septal Defect Without Cardiopulmonary Bypass: Five-Year Follow-Up Results
Quansheng Xing, Qin Wu. Children’s Hospital of Qingdao University, Qingdao, China.
Objective: Recently, minimally invasive transthoracic device closure (MITDC) of ventricular septal defect (VSD) under transesophageal echocardiography. (TEE) guidance is increasingly successfully performed with excellent results. We retrospectively reviewed 508 patients who received this treatment in our center, and summarized the 5-year follow-up results.
Methods: From March 2007 to March 2012, 508 cases with VSD size from 3 to 12 cm (5.3±4.6 cm) underwent this procedure. All the procedures were performed in the operating room. A 3-5 cm inferior sternotomy or the left third intercostals incision was made. Under TEE guidance, through the chosen RV free wall point, the delivery system with occlusion device of appropriate size was introduced into RV cavity, defect and then left ventricular (LV) cavity. Then following the LV disc, waist and the RV disc were deployed in LV, septum and RV respectively. After complete TEE assessing for absence of complications, the device was released. Patients were followed up with a standard protocol.
Results: 485 cases were successfully closed (95.5%), and the procedures were converted to conventional open-heart repair in 23 patients (4.5%). Concentric device was used in 288 cases (59.4%), eccentric device in 184 cases (37.9%) and special ones in 13 cases (2.7%). The mean operating time was 18.5±11.9 min. (3 to 48 min.). Most of the patients were discharged within 5 days after operation. Follow-up in 467 patients (96.2%) ranged from 3 to 63 months (36.3±11.6 months) reveals no severe complications except for one complete heart block 6 months after operation which received sinus rhythm after the device being taken out and the defect closed surgically.
Conclusions: MITDC of VSD on beating heart is a safe and effective alternative to conventional treatments. The 5-year clinical outcomes are promising, and long-term follow-up is mandatory.
CV4 Per-Ventricular Device Closure of Doubly-Committed Subarterial Ventricular Septal Defects
Da Zhu, Ke Lin. 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 video was to demonstrate the perventricular closure technique in managing this type of VSD.
Methods: The surgical incision is through a 2-3 cm left anterior mini-thoracotomy. A domestic-made eccentric VSD device (SHAMA Corp, Shanghai, China) is used during the procedure. A mattress suture was placed in the RV surface, and a 20-gauge needle was inserted into the RV cavity. A wire was introduced into the left ventricle through the defect. A double-lumen delivery sheath was advanced into the left ventricle over the guide wire and the device was delivered through the prepared loader sheath and the delivery sheath. Once the expanded left ventricular disc, the device was rotated until the eccentric side of the disc was opposite to the site of the aortic valve. Then the cable and delivery sheath were simultaneously withdrawn, the waist as well as the RV disc were subsequently deployed under the guidance of the trans-esophageal echocardiogram.
Results: Our initial result of this procedure was encouraging with no mortality as well as severe complication such as device embolism, significant arrhythmias and noticeable valve regurgitation during both hospital stays and follow-up (data is showed in Table CV4-1).
Conclusions: Perventricular closure of doubly-committed subarterial VSDs appears to be safe, effective and minimal invasive technique.
C17 Defining the Role of Chest Radiography in Determining Candidacy for Minimally Invasive Pectus Excavatum Repair
Joseph W. Turek, Patrick M. Poston, Nicholas O. Rossi, James E. Davis. University of Iowa, Iowa City, IA USA.
Objective: Pectus excavatum (PE) is the most common congenital anomaly of the chest wall. The Haller Index (HI), derived from a computed tomography (CT) of the chest, remains the standard for determining PE severity and is the basis for insurance approval of minimally invasive repair. The ability to accurately determine PE severity from two-way chest radiography (CXR) may provide substantial cost savings. As such, this study proposes to establish data-driven criteria for the use of CXR as a diagnostic modality in the preoperative evaluation of PE patients.
Methods: A database of PE patients receiving preoperative CXR and CT from January 2003 to July 2012 was created. Haller indices were obtained from radiologic reports of CT scans. Two pediatric cardiothoracic surgeons, blinded from the CT HI scores, independently calculated CXR HIs. Inter-rater reliability, correlations, sensitivity, specificity, and accuracy were then calculated.
Results: The database was comprised of 77 patients. A significant correlation was found between CXR HI estimates of the two observers, r=0.83. There were also significant correlations between the CXR and CT HI for observer 1, r=0.93 and for observer 2, r=0.77. CT HIs were used as the standard for identifying patients meeting surgical criteria (CT HI≥3.2). From this, sensitivities, specificities, and accuracies were calculated for the corresponding CXR HIs determined by each observer. Observer 1 CXR HI estimates had a sensitivity of 0.98, specificity of 0.82, and accuracy of 0.91. Observer 2 CXR HI estimates had a sensitivity of 0.93, specificity of 0.62, and accuracy of 0.78.
Conclusions: Utilizing the largest reported database of PE patients with both preoperative CXR and CT scan, we found a strong correlation between HIs calculated with each modality. Additionally, observed CXR HIs demonstrated good inter-rater reliability. While the sensitivity of CXR in diagnosing severe PE (CT HI ≥3.2) was high, specificity was less convincing. However, when only considering measured CXR HIs ≥3.75, combined specificity was quite high (0.93). Thus, we recommend replacing CT with CXR in the preoperative evaluation for patients with PE. CT should be used as a confirmatory test in those patients measured to have a CXR HI between 3.2-3.75.
C18 Minimally Invasive Placement of a Novel Direct Epicardial Assist Device in a Porcine Heart Failure Model
Jeremy McGarvey, Norihiro Kondo, Manabu Takebe, Toru Shimaoka, Satoshi Takebayashi, Walter R. T. Witschey, Gerald A. Zsido, II, JosephH.Gorman, III, James J. Pilla, Robert C. Gorman. University of Pennsylvania, Philadelphia, PA USA.
Objective: Despite advances in design, modern ventricular assist device (VAD) placement involves median sternotomy, cardiopulmonary bypass, and is associated with infectious/embolic complications. Accordingly, innovative approaches to assistive therapies for ischemic cardiomyopathy (ICM) remain in great demand. In this study, we examine the feasibility and function of a novel minimally invasive, off-pump epicardial assist device in a porcine ICM model.
Methods: Five male Yorkshire swine underwent selective ligation of the circumflex artery and its branches to create a 23.8±1.5% posterolateral infarct. Twelve weeks post-infarct, all animals underwent left mini-thoracotomy. A custom inflatable bladder was positioned over the epicardial surface of the infarct and firmly secured to surrounding borderzone myocardium with polypropylene mesh and minimally-invasive mesh tacks (Figure C18-1A). The inflation port was externalized through the chest wall and connected to an external gas pulsation system which actively inflated and deflated (Figure C18-1B, C18-C, respectively) the bladder in synchrony with the cardiac cycle. All animals then underwent pressure-gated 3D cardiac MRI to assess device and ventricular function. Post-mortem, the heart was examined for evidence of mesh dehiscence, device damage, coronary injury, and ventricular perforation.
Results: All subjects successfully underwent off-pump placement of the novel epicardial assist device via mini-thoracotomy. Total operative time was under 30 minutes in all cases. Ejection fraction (EF) significantly improved from 29.1±4.8% to 39.6±4.23% (p<0.001) when compared to pre-treatment. End-systolic volume decreased (76.6±13.3 ml vs. 62.4±12.0 ml, p<0.001) and stroke volume increased (28.6±3.4 ml vs. 37.9±3.1 ml, p<0.05) when assisted. No change was noted in end-diastolic volume (105.1±11.4 vs. 100.3±12.7). On post-mortem examination, mesh fixation and device position were excellent in all cases. No complications were noted.
Conclusions: Directed epicardial assistance improves global ventricular function in a porcine ICM model, and may provide a safe alternative to currently available invasive VAD therapies. Minimally invasive, off-pump placement of the novel assist device was easy and technically uncomplicated. Further, the technique used for device positioning and fixation suggests an entirely thoracoscopic approach is possible.
C19 Clinical Outcomes of Patients More Than One-Year after Minimally Invasive Mitral Valve Repair and Replacement Surgery with Sutures Secured using Automated Titanium Fasteners
Roberto Rodriguez, Francis P. Sutter, Louis E. Samuels, Daniel Ice, Susan Morrissey, Kathleen M. Holzerman, Scott Goldman. Lankenau Medical Center, Wynnewood, PA USA.
Objective: To evaluate the clinical outcomes of minimally invasive cardiac surgery patients followed for at least one year after mitral valve repairs and replacements with prosthetic attachment sutures secured by automated titanium fasteners.
Methods: We conducted a single-institution retrospective review of clinical outcomes for patients involved in an on-going IRB study regarding minimally invasive mitral valve surgery. During the 26-month period from November 2008 to December 2010, a total of 133 minimally invasive mitral valve repairs or replacements were performed at our institution using automated titanium fastener technology. Patient post-operative histories, physician records and follow-up studies, such as echocardiography, were analyzed.
Results: Patient records from a total of 119 consecutive mitral valve repairs and 14 mitral valve replacements were reviewed. All mitral prosthetic rings were successfully attached with automated titanium fasteners. All 14 mitral valve replacements were also secured without manually tied knots. Other concomitant procedures included 48 MAZE procedures and 22 patent foramen ovale closures. A total of six study procedures were reoperations, with the previous procedure being coronary artery bypass surgery. Whenever possible, patient mitral valves were evaluated by echocardiography post-operatively and/or by the surgeon at the one-year follow-up visit. Twenty-three patients (17%) were lost to follow-up. The latest echocardiogram was performed an average of 505 days following surgery. No patient had evidence of thrombus formation or hemolysis. One instance of mitral ring dehiscence was noted amongst the repair patients and no perivalvular leaks occurred amongst the replacements. In the patient with the mitral ring dehiscence, the dehiscence was due to a tear in the mitral annulus and not associated with the titanium fasteners, which all remained intact. The overall study mortality rate was 1.5% and stroke rate was 2.25%. No adverse outcomes were attributable to the use of automated titanium fasteners.
Conclusions: At a minimum of one-year follow-up, automated titanium fasteners appear to be safe and effective for securing prosthetic attachment suture in minimally invasive mitral valve repair and replacement surgery.
CMP26 Significant Reduction in Operative Times Using Cor-Knot in Robot-Assisted Mitral Valve Repair
L. Wiley Nifong, Hazaim Alwair, Douglas Parker, Dhagash Patel, W. Randolph Chitwood, Jr. East Carolina Heart Institute, Greenville, NC USA.
Objective: A substantial barrier to widespread adoption of robot-assisted mitral valve repair surgery (RAMVP) is increased operative time when compared with median sternotomy operations. The Cor-Knot device (LSI Solutions, Inc., Victor, NY USA) uses a titanium clip to secure sutures, eliminating intra-cardiac knot tying and reducing operative times.
Methods: In this review of our retrospective RAMVP operative data, we compare total times for Cor-Knot delivery or robotic suture tying, as well as annuloplasty band placement (ABP), cardiopulmonary bypass (CPB), and aortic cross-clamping (XC). Patients in whom Cor-Knot was used (N=48) were compared with those where robotic suture tying was used (n=288). Comparisons between groups were analyzed using two-tailed Student’s t-test.
Results: Between May 2000 and December 2012, 800 patients underwent RAMVP at our institution. The mean age was 59.7±12.1 years (mean ± SD) for those studied. Operative results are summarized in Table CMP26-1. All differences were significant, p<0.02. The mean Cor-Knot device time for annuloplasty deployment was significantly shorter when compared with robotic knot tying. Furthermore ABP, CPB, and XC times also were significantly shorter in the Cor-Knot cohort.
Conclusions: When compared to intra-cardiac robotic suture tying for RAMVP, the Cor-Knot device shortens all operative times significantly. The mean annuloplasty band placement time was reduced by 10 minutes. Moreover, CPB and XC times were significantly shorter in the Cor-Knot cohort. A randomized study is required to confirm these findings.
C20 Early Experience With Perceval S Sutureless Bioprostheses in Patients Undergoing Minimally Invasive Aortic Valve Replacement via Right Anterior Minithoracotomy
Antonio Miceli, Michele Murzi, Danyiar Gilmanov, Matteo Ferrarini, Raffaele Fugá, Alfredo G. Cerillo, Stefano Bevilacqua, Simone Simeoni, Pier A. Farneti, Marco Solinas, Mattia Glauber. Fondazione Toscana G. Monasterio, Massa, Italy.
Objective: To evaluate the postoperative outcomes of Perceval S sutureless bioprostesis in patients undergoing minimally invasive aortic valve replacement (MIAVR) through right anterior minithoracotomy (RT).
Methods: From March 2011 to September 2012, 94 consecutive patients (mean age 77.2±6.5 years) underwent MIAVR through RT with Perceval S sutureless bioprostheses. RT was performed through a skin incision of 5-7 cm placed on the second intercostal space. Direct aortic and percutaneous femoral cannulations were routinely used.
Results: In-hospital mortality was 0% with a median predicted EuroSCORE of 9% (range 5%-30%). The mean aortic cross-clamp and cardiopulmonary bypass times were 42.7±13 and 72.5±23 minutes, respectively. Median intensive care unit stay was 1 day (range 1-2 days) and patients were discharged after 6 (range 4-14) days. Stroke occurred in 1 patient. Incidence of permanent pacemaker was 0%. Hemodynamic at discharge showed good function of all Perceval S valves with low transvalvular pressure gradients (mean, 10±4 mmHg and peak, 21±8 mmHg). No migration or dislodgement of the valve occurred, but two mild paravalvular leakages were recorded. At median follow-up of 8 months, survival and freedom for reoperation were 100%, respectively.
Conclusions: In patients undergoing MIAVR through RT, the implantation of Perceval S sutureless bioprosthesis is simple and associated with excellent early clinical and hemodynamic outcomes. RT might be an alternative to TAVI procedures for high-risk patients.
CMP27 Mini-Thoracotomy for Sutureless-Rapid-Deployment Aortic Valve Replacement: Initial Single-Center Experience
Günther Laufer, Dominik Wiedemann, Amit Vadehra, Raphael Rosenhek, Thomas Binder, Alfred Kocher. Medical University of Vienna, Vienna, Austria.
Objective: A new class of rapid deployment aortic valves has emerged with the potential to simplify minimally invasive aortic surgery and reduce cross-clamp and cardiopulmonary bypass times. We report the first experience of aortic valve replacement with the EDWARDS INTUITY Valve System Generation 2 via a right thoracotomy.
Methods: Between May 2011 and July 2012, 13 patients (age 79 (44-92); 50% female) with aortic stenosis requiring valve replacement were treated at our center by a single surgeon. A stented tri-leaflet bovine pericardial bioprosthesis with a balloon expandable cloth-covered stent frame at the inflow aspect was implanted through a right thoracotomy with a 7 cm skin incision. The aorta was directly cannulated whereas the venous cannula was inserted percutaneously via the femoral vein. Four valve sizes were implanted 21 to 27 mm. Patients were followed at discharge, 3 months, and 1 year postoperatively.
Results: One patient had to be excluded due to a true bicuspid valve with 2 commissures and no raphe. Implantation success was 100% in the remaining 12 patients; no early valve-related mortality was observed. Cardiopulomonary bypass time and aortic cross clamp time were 121 ±6 min and 86 ±5 min respectively. Mean pressure gradient and peak pressure were 13.4 ±1.8 mmHg and 22.4 ±2.1 mmHg at discharge, and 9.4 ±1.0 mmHg and 18.5 ±2.0 at 3 months, respectively.
Conclusions: In this first, single-center experience implantation of the EDWARDS INTUITY Valve System through a mini-thoracotomy has been shown to be feasible, safe, and effective for aortic valve replacement. The fast and simple implantation technique facilitates a short operation time. Early hemodynamic performance was excellent.
CMP28 Left Ventricular Mass Regression After Two Alternative Sutureless Aortic Bioprostheses
Giovanni Concistré1, Steffen Pfeiffer1, Giuseppe Santarpino1, Francesca Chiaramonti2, Antonio Miceli2, Marco Solinas2, Mattia Glauber2, Theodor Fischlein1. 1Klinikum, Nuremberg, Germany, 2Ospedale del cuore “G.Pasquinucci” - Fondazione Monasterio - CNR, Massa, Italy.
Objective: Left ventricular (LV) hypertrophy in aortic stenosis (AS) is considered a compensatory response helping to maintain systolic function, but it constitutes a risk factor for cardiac morbidity and mortality. The aim of this study was to investigate the degree of LV mass regression after aortic valve replacement (AVR) with 2 alternative sutureless self-expanding strategies: Perceval S (Sorin Group, Saluggia, Italy) (“P”) and 3f Enable (Medtronic, ATS Medical, Minneapolis, MN USA) (“E”) aortic bioprostheses.
Methods: Between March 2010 and December 2011, 129 patients with symptomatic AS underwent AVR with the Perceval S or 3f Enable bioprostheses in 2 Cardiac Surgery Departments (Nuremberg, Germany and Massa, Italy). We analyzed 45 patients in Group P and 19 in Group E undergoing isolated AVR with a six-month clinical and echocardiographic follow-up. The LV mass was calculated using the Devereux formula and was indexed to body surface area.
Results: Baseline patient characteristics showed not significant differences between groups. There were no in-hospital deaths. Two patients in P died at follow-up vs. zero in E (p=0.49). Mean LV mass index decreased from 146.6 ± 78 g/m2 at baseline to 123.3 ± 63 g/m2 at follow-up (p<0.001) in P and from 146.1 ± 47.6 g/m2 to 118.1 ± 39.8 g/m2 (p=0.003) in E with no significant difference between the 2 groups (p=0.315). LV ejection fraction did not change significantly over time. Mean indexed effective orifice area at follow-up was 1.34 cm2/m2 in P and 1.27 cm2/m2 in E (p=0.74). Mean transaortic gradient decreased to 10.4 ± 4.3 mmHg in P and to 12.2 ± 5.3 mmHg in E-Group (p=0.184). This effect was accompanied by significant clinical improvement.
Conclusions: In isolated aortic stenosis, AVR with sutureless bioprostheses determines a significant regression in LV mass at six-month follow-up. Not significant differences were present with the 2 alternative sutureless strategies. However, regression needs an evaluation with long-term echocardiographic examinations.
C21 Minimally Invasive, Video-Assisted Repair of Mitral Valve Insufficiency: Surgical Strategies as a Single-Center Experience
Jan-Philipp Minol, Udo Boeken, Tobias Weinreich, Hildegard Gramsch-Zabel, Payam Akhyari, Hiroyuki Kamiya, Artur Lichtenberg. University Hospital, Duesseldorf, Germany.
Objective: Today, there is great diversity with regard to techniques for repair of organic mitral valve regurgitation. In our department, we use a highly standardized strategy for this pathology.
Methods: For the prolapse of the anterior leaflet, implantation of neo-chordae (4/0 Gore-Tex) was the technique of choice. Only in the event of a P2-prolapse with excessive tissue was a resection of the leaflet performed. A sliding plastic was inevitable in cases of calcification of the annulus or high risk for systolic anterior motion. Prolapse of P1 and P3 was always treated with neo-chordae, independent of the size of the segment. This technique was used only for small 2-segments. Cleft closure was an option for residual regurgitation through the cleft or to adjust the height of coaptation to an adjoining segment. For Barlow-patients, P2-resection and chordal transfer from P2 to A2 was performed. We always use an annuloplasty ring, nowadays mostly an open ring (Medtronic Future-Band) predominantly to avoid systolic anterior motion. A closed ring (Edwards Physio-Ring) was used only in the first patients of our series.
Results: Between August 2009 and September 2012, we identified 156 patients (77 males, 19 patients with tricuspid valve repair) with mitral valve regurgitation (Carpentier Type II) from 285 patients undergoing video-assisted minimally-invasive mitral valve surgery via right mini-thoracotomy. Using our standardized strategy, repair rate was 96% in all patients, 87% for the anterior prolapse (15 patients), 99% for the posterior prolapse (106 patients, P2-resection in 37 patients), 82% for the prolapse of the both leaflets (17 patients) and 100% for Barlow-syndrome (16 patients). A closed ring was used in 48 patients (mean size 32.3 ± 1.5 mm) and an open ring was used in 108 patients (mean size 32.7 ± 1.7 mm). Conversion to full sternotomy was necessary in 3 patients (1.9%) and early mortality was 1.3%.
Conclusions: We could show that a reconstruction of an insufficient mitral valve can be performed in the majority of patients in a minimally invasive, video-assisted technique. However, it is necessary to use a standardized strategy with restrictive use of leaflet resection and aggressive use of an open ring.
CMP29 Minimally Invasive Septal Myectomy for the Treatment of Hypertrophic Obstructive Cardiomyopathy
Amine Mazine, Michel Carrier, Antoine Rochon, Denis Bouchard. Montreal Heart Institute, Montreal, QC Canada.
Objective: Transaortic septal myectomy is the gold standard for the treatment of symptomatic hypertrophic obstructive cardiomyopathy refractory to medical therapy. The aim of this study was to assess perioperative outcomes and early clinical results of minimally invasive septal myectomy performed via a small parasternal incision.
Methods: Between May 2011 and September 2012, 8 patients underwent isolated septal myectomy via a 5 cm right parasternal minithoracotomy. Preoperative and pre-discharge transthoracic echocardiograms (TTE) were obtained for each patient.
Results: Mean age was 56 ± 11 years and six (75%) patients were male. Median preoperative NYHA class was III/IV and three patients (38%) had a previous percutaneous alcohol septal ablation attempt that failed. One patient (13%) had preoperative atrial fibrillation and right bundle branch block. Preoperative TTE evaluation showed the presence of systolic anterior motion of the mitral valve in all patients and median mitral regurgitation grade was 2/4. Mean cardiopulmonary bypass time was 63.8 ± 14.8 minutes and mean aortic cross-clamp time was 53.6 ± 16.2 minutes. There was no intraoperative conversion to sternotomy. Median postoperative length of stay was 5.5 days. There was no in-hospital mortality. Reexploration for bleeding was performed in one patient (13%). Postoperative implantation of a permanent pacemaker was necessary in 3 (38%) patients, including two (25%) who suffered from complete atrioventricular block and one (13%) who suffered from atrial fibrillation and left bundle branch block. Pre-dicharge TTE evaluation showed marked reduction in both septal thickness (21.3 ± 2.8 to 14.9 ± 3.1 mm, p = 0.012) and peak LVOT gradient (71.0 ± 26.6 to 19.7 ± 7.4 mmHg, p = 0.018). Clinical follow-up was available in 6 (75%) patients at a mean follow-up of 3.1 ± 2.6 months. At last follow-up, all patients were alive and in NYHA functional class I.
Conclusions: This study demonstrates the feasibility of transaortic septal myectomy through a right minithoracotomy. Our early results suggest that this technique is safe and effective. However, further studies with larger cohorts and long-term follow-up are warranted.
CV5 Septal Myectomy and Mitral Valve Repair Using Robotic Assistance
L. Wiley Nifong, Stuart Bumgarner, Pooja Sarin, Hazaim Alwair, W. Randolph Chitwood, Jr. East Carolina Heart Institute, Greenville, NC USA.
Objective: The left ventricular outflow tract (LVOT) is adjacent to the anterior leaflet of the mitral valve. The patient in this video presented with obstructive symptoms of the LVOT. We attempted treatment for hypertrophy of the ventricular septum using robotic techniques.
Methods: Access to the LVOT and mitral valve were through the right chest and peripheral cannulation was used. The da Vinci Robotic System (Intuitive Surgical, Inc., Sunnyvale CA USA) was used to resect the hypertrophied septum and repair the mitral valve. Myectomy was done after releasing the anterior mitral leaflet from the annulus. After myectomy, the anterior leaflet was reattached, and the mitral valve was repaired.
Results: Successful myectomy and mitral valve repair were done using robotic assistance. The patient made a full recovery.
Conclusions: Improved instrumentation and visualization allowed for precise excision of hypertrophied septum. Many procedures done by traditional approaches can be performed safely using robotic techniques.
CMP30 Mid-term Results of Repaired Barlow Mitral Valves via Right Minithoracotomy vs. Median Sternotomy in a Randomized Trial
Giuseppe Nasso1, Vito Romano1, Mario Siro Brigiani1, Raffaele Bonifazi1, Francesco Bartolomucci2, Giuseppe Speziale3. 1Division of Cardiac Surgery, Anthea Hospital, GVM Hospitals of Care and Research, Bari, Italy, 2Division of Cardiology, “L. Bonomo Hospital”, Andria, Italy, 3Anthea Hospital, GVM Hospitals of Care and Research, Bari, Italy.
Objective: It has been previously reported that the results of valve repair for complex mitral lesion (Barlow valve) via right minithoracotomy is not inferior to the median sternotomy approach at the earliest follow-up. We addressed whether such results are maintained at the intermediate-term follow-up.
Methods: In the setting of a prospective randomized study of mitral repair for Barlow disease (bileaflet prolapse) via the minimally invasive route (MI group) vs. median sternotomy (MS group), we achieved an average three-year follow-up (echocardiography, physical exam and quality-of-life assessment: SF-36 questionnaire). Mitral repair was achieved with polytetrafluoroethylene chordal implantation for both leaflets. In the MI group, we used right minithoracotomy, peripheral cannulation, external aortic clamping, and surgery under direct vision.
Results: Both groups included 80 patients. Mechanical ventilation time, intensive care unit and hospital stay were shorter in the MI group (p=0.01, p=0.013 and p=0.02, respectively). During the follow-up, 5 patients in each group (6.25%) displayed residual mild mitral regurgitation, while 2 patients in each group (2.5%) developed recurrent mitral regurgitation graded at least moderate/severe and symptoms of heart failure. The rate of mitral reoperation was 2.5% in the MI group and 1.25% in the MS group (p=0.9). The overall mortality at the end of the follow-up was 3.75% in the MI group and 1.25% in the MS group.
Conclusions: The three-year results of repair of Barlow valves are satisfactory irrespective to the approach used to repair the valve (minithoracotomy vs. sternotomy). The advantages of minimally invasive surgery can be confidently achieved in patients with Barlow disease of the mitral valve, without concerns over the durability of repair.
C22 Right Mini-Thoracotomy versus Median Sternotomy for Mitral Surgery in Patients with Chronic Renal Impairment: A Propensity-Matched Study
Paul C. Tang, Mark W. Onaitis, Jeffrey G. Gaca, Carmelo A. Milano, Donald D. Glower. Duke University Medical Center, Durham, NC USA.
Objective: Compared to conventional median sternotomy (MS), a right mini-thoracotomy (RT) approach to mitral surgery is associated with lower postoperative rise in creatinine and decreased incidence of acute renal failure. Therefore, we retrospectively examined propensity-matched patients with chronic renal impairment to compare the mortality and morbidity between the MS and RT techniques.
Methods: We performed a retrospective review of the Duke cardiothoracic surgery database from 1986 to 2010 and identified patients who underwent mitral valve surgery. Patients who had procedures that were not usually performed through a RT approach (e.g., aortic valve or aortic surgery) were excluded. Of the 2306 patients fulfilling the above criteria, we identified 445 patients with preoperative creatinines of 1.3mg/dL or greater. Using 1:1 propensity score matching based on comorbidities, operative year and surgeon, we obtained 90 matched patients per group for outcomes analysis.
Results: There was no difference in median year of operation between the two groups (2001 vs. 2003, P=0.180). Mortality was 20% lower for the RT group (P=0.009) using Mantel-Cox statistics. This greater survival in the RT group occurred within the first year and was maintained on long-term follow-up (Figure C22-1). A RT approach was associated with a Cox proportional hazard for mortality of 0.507 (P=0.007). Incidence of complications with a RT approach was lower for new onset atrial fibrillation (21% vs. 79%, P=0.046), acute renal failure (9% vs. 28%, P=0.001), initiation of dialysis (6% vs. 13%, p=0.074), and tracheostomy (2% vs. 9%, P=0.05). Operative parameters for RT versus MS groups are duration of aortic cross clamp (68 vs. 90 min., P=0.037) and cardiopulmonary bypass (179 vs. 171 min., P=0.233). RT had lower chest tube output (490 vs. 1369 ml, P<0.001) and packed red blood cell transfusions (3.4 vs. 5 units, P=0.025).
Conclusions: A RT approach compared with MS was associated with lower postoperative mortality and morbidity in patients with impaired renal function. RT is preferred in this high-risk population with mitral valve disease.
CMP31 A Novel Surgical and Trans-Catheter Mitral Repair Device: Tested Using an in vivo Sheep Model of Severe Mitral Regurgitation
Arthur C. Hill1, Michael Lesh2, Alexander Khairkhahan2. 1University of California, San Francisco, San Francisco, CA USA, 2Middle Peak Medical, Palo Alto, CA USA.
Objective: We are developing a novel percutaneous transcatheter implant for treating severe mitral regurgitation (MR). The device, constructed of standard surgical materials, provides a polymeric posterior leaflet surface, restoring normal coaptation with the anterior leaflet. We describe here proof-of-concept by evaluating MR elimination using open surgical implantation in sheep. A second phase of the project will consist of in vivo testing of the percutaneous trans-septal system.
Methods: In 9 sheep, we created a model of severe (4+) flail MR by severing one or more chords to P2. After minimally invasive left thoracotomy and cardiopulmonary bypass, the device was surgically implanted, and the animal weaned from CPB. Residual MR was evaluated by ventriculography and/or epicardial and transthoracic echocardiography. Sacrifice was acute in 4 and chronic in 5 (1-7 months post-operatively).
Results: Flail P2 with 4+ MR was successfully created in all sheep; this preparation was documented to produce immediate fatality without repair. Device implantation resulted in MR ≤ 1+ in 4/4 acute and 4/5 chronic sheep. Clinical status at follow-up, residual MR, thrombosis, and histopathology for the chronic group is shown in Table CMP31-1.
Conclusions: In an ovine model of flail P2, we demonstrated that a novel mitral implant can eliminate 4+ MR by providing a new surface onto which the anterior leaflet may coapt. No thromboemboli or other complications occurred. The device has undergone minor iterative modification and has characteristics that will allow its use in posterior leaflet degenerative disease, functional MR, and rheumatic MR. Development of a 16 Fr percutaneous transcatheter delivery system is ongoing. In addition, surgical implantation in patients with severe MR is an option using minimally invasive and robotic approaches.
CMP32 Aortic Valve Bypass Using a Novel Automated Device for the Treatment of High-Risk Aortic Valve Stenosis on a Beating Heart
Gabriele Di Giammarco, Carlo Canosa, Massimiliano Foschi. University of Chieti, Chieti, Italy.
Objective: The number of high-risk patients requiring aortic valve replacement is increasing with increased prevalence of comorbidities in the elderly candidates or redo cases. The option of an apico-aortic bypass using valved conduits is not new. We report the results with the use of a novel device incorporating a bioprosthetic stentless valve and designed to be used on a beating heart.
Methods: From March 2012 to December 2012, 11 patients were submitted to aortic-valve bypass (AVB) to treat a severe aortic valve stenosis using a novel system. It is structured into 2 components: a valved conduit incorporating a stentless bioprosthesis to be anastomosed of descending aorta and a ventricular conduit to be implanted on the left ventricular apex using an automated coring device. Patients mean age was 77±7 yrs (36% males). Mean ejection fraction (EF) was 53±13%. Mean preoperative NYHA class was 2.3±0.75. The mean log EuroSCORE was 16.4±13.6%; mean EuroSCORE II was 5.5±3.7%; mean STS score risk of mortality and morbidity/mortality were respectively 4.3±2.3% and 21.8±5.2%. All the patients received AVB through a mid-lateral thoracotomy. The design of the system makes cardiopulmonary bypass not necessary. In one patient a concomitant left anterior descending (LAD) stenosis was revascularized during the same procedure using a left internal mammary artery (LIMA) on a beating heart without cardiopulmonary bypass. In one patient we planned to use ECMO to support lung function cause of a preoperative severe respiratory failure.
Results: The median duration of the AVB implant was 120 min. (25th-75th percentile 108 - 137). No intraoperative deaths occurred. Mean ICU stay and intubation time were respectively 36.7±18.3 and 18.5±8.72 hours. The mean duration of hospital stay was 11.6±3.77 days. No cerebrovascular accidents occurred. There were two in-hospital deaths, both from hemorrhagic shock not related to operation: a 91-year-old female who died after liver rupture following a complicated thoracentesis and a 73-year-old male who died from massive gastrointestinal bleeding. One patient (11%) died 3 months after operation from an undiagnosed, silent hepatic carcinoma.
Conclusions: AVB with automated ventricular coring system is an alternative to conventional aortic valve replacement in high-risk patients in which there is some contraindication to transcatheter aortic valve implantation (TAVI) procedure or TAVI is not possible for technical reasons. To the best of our knowledge, this is the largest single-center experience to date.
CMP33 Repair of Mitral and Tricuspid Valves Using Bioresorbable Acellular Xenograft
Marc W. Gerdisch. Franciscan St. Francis Heart Center, Indianapolis, IN USA.
Objective: A limitation to valve tissue replacement is lack of synthetic or xenograft material that will not induce inflammation. Pericardial xenografts offer early performance but immunologic rejection leads to calcification, shrinkage and degeneration. Use of bioresorbable extracellular matrix (ECM) with resultant growth of site-specific tissue provides repair of cardiac structures with no residual foreign body. This study investigates the durability and mid-term function of ECM mitral and tricuspid reconstructions.
Methods: We have used ECM to perform 98 intra-cardiac repairs. These cases include the first-known repairs and follow-up of mitral and tricuspid valves, using ECM. From September 2008 to November 2012, 17 mitral and 3 tricuspid valves were repaired using ECM. These consisted of acute and chronic endocarditis, subtotal and partial leaflet replacement, leaflet extension and reconstruction of atrio-ventricular continuity following annular decalcification. 17 cases required replacement of a portion of leaflet. Following debridement as necessary, ECM was tailored and sewn to native tissue, edge-to-edge with running 5-0 poly-propylene. Detailed intra-operative photography (Figure CMP33-1A) and follow-up echocardiography (Figure CMP33-1B) were used for evaluation.
Results: Intra-operative photography demonstrates excellent achievement of architectural reconstruction. Two (2) patients returned with mitral regurgitation at 3- and 14-months post-op. Both had a history of cancer and high dose chemotherapy. All other repairs remain functional on echocardiographic follow-up between 1 and 36 months. Operating room photography and serial echo images are reviewed.
Conclusions: The commercial availability of ECM for intra-cardiac reconstruction introduces the opportunity to re-grow portions of valve architecture. The acellular ECM provides support and function, while newly created tissue replaces the matrix. As a result, calcification of xenograft implants is avoided and valves are preserved that might otherwise be replaced. The patients’ ability to provide progenitor cells to populate the matrix may need consideration. Ease of implantation makes ECM an excellent tool at surgery. Its bioresorbtion and replacement by site-specific recipient tissue makes it a unique and potentially superior implant.
CV6 Simulation of Video-Assisted Minimal Invasive Mitral Valve Surgery: A Low-Cost Custom-Made Device for Training Programs
Hassina Baraki, Shunsuke Saito, Bernhard Fleischer, Ulrich Molitoris, Ammar Al Ahmad, Axel Haverich, Ingo Kutschka. Hannover Medical School, Hannover, Germany.
Objective: Simulation provides the opportunity to improve technical skills outside the operating room. Our aim was to build a simple, cost-effective and reproducible device for training and education in mitral valve surgery.
Methods: The device is made of a wooden box with a hole in the front side. The mitral valve is simulated by two plywood panels. The first panel represents the mitral annulus with disposable microfiber membranes simulating the leaflets. The second panel is mounted behind the first one and contains the papillary muscles made from replaceable foam rubber. An USB camera and a LED light source are integrated to simulate video-assisted surgery. All components are placed inside the box for easy storage and transportation.
Results: This low cost (∼ 80), portable simulator allows for education and training of mitral valve surgery (e.g., annuloplasty, sliding plasty, leaflet resection, placement of neochordae, valve replacement). For teaching purposes the simulator can be used with open lid to provide a good view for the mentor, while the trainee is practicing the minimal invasive approach through the front access. Closing of the lid and using the USB camera, connected to any available computer, simulates the reality of minimal invasive, video-assisted surgery.
Conclusions: This simulator represents a new innovative tool for training and teaching of minimal invasive mitral valve surgery. Its manufacturing is simple and cost effective. It may contribute to improve training programs and learning curves.
CMP34 Can the Learning Curve of Totally Endoscopic Robotic Mitral Valve Repair be Short-Circuited?
David W. Yaffee, Didier F. Loulmet, Lauren Kelly, Alison F. Ward, Patricia A. Ursomanno, Annette Rabinovich, Krishnan Sandeep, Frederick T. Hill, Eugene A. Grossi. New York University School of Medicine, New York, NY USA.
Objective: A concern with the initiation of totally endoscopic robotic mitral valve repair (TERMR) programs has been the significance and associated risk of the learning curve. In an attempt to minimize this risk we initiated a TERMR program with a defined team and structured learning approach prior to clinical implementation.
Methods: A dedicated team (two surgeons, one cardiac anesthesiologist, one perfusionist, two nurses) was trained with clinical scenarios, training simulations, wet lab courses, and direct ‘expert’ observation for 3 months. This team then performed a series of TERMRs of varying complexity using retrograde arterial perfusion and endoaortic balloon occlusion. All knot tying was performed with a knot-pusher except for annuloplasty device sutures which were crimp terminated.
Results: Thirty-two isolated TERMRs were performed during the first year. Mean age was 56±13 years. All procedures included mitral valve repair, left atrial appendage exclusion, and annuloplasty device implantation. Additional procedures included: leaflet resection (n=15), neochordae insertion (n=10; range 2-6/patient), ablation (n=3), and papillary muscle shortening (n=5). Mean procedural times are listed in Table CMP34-1. Multivariate regression demonstrated that longer clamp times were associated with leaflet resection (p=0.06), number of neochordae (p=0.001), and papillary muscle procedures (p=0.001). Sequential case number had no impact on cross clamp time (p=0.25). Logarithmic analysis of total operative time demonstrated an 18.7% learning percentage (p=0.002) (i.e., 18.7% reduction in operative time with each doubling of case number). There were no hospital deaths. There were no postoperative incidences of stroke, myocardial infarction, reoperation for bleeding, respiratory failure, renal failure, or unplanned reoperations. Median length of stay was 4 days and all patients were discharged home.
Conclusions: TERMR can be safely performed without increased risk to patients by using a pre-training regimen with emphasis on experts’ current practice and team training. Cross-clamp times were not subject to learning curve phenomena but were dependent on procedural complexity. Following the pre-training regimen, total operative times are associated with a high-learning percentage and therefore a short learning curve.
CMP35 Right Minithoracotomy Approach in Atrio-Ventricular Valve Infective Endocarditis: Single-Center Experience
Chiaramonti Francesca. Heart Hospital G. Pasquinucci FTGM, Massa, Italy.
Objective: Right minithoracotomy (RT) is an alternative surgical approach for patients undergoing mitral valve (MV) or tricuspid valve (TV) surgery. However, the role of this technique in patients with infective endocarditis (IE) remains unclear. The objective of this study was to examine the feasibility and outcomes following minimally invasive atrio-ventricular valve (A-VV) surgery for IE.
Methods: Between January 2004 and September 2012, 69 patients underwent A-VV surgery for IE. Of these fifty-eight (84%) patients had a RT. A retrospective review of this patient population was performed.
Results: In-hospital mortality was 3% (n=2). Mean age was 59.6±13.6 years and mean Logistic EuroSCORE was 12.1±8.75. Forty-nine patients (84%) had native mitral valve IE and 9 (16%) had prosthetic mitral valve IE. Thirty-five patients (60%) were operated during the active phase of IE. Cardiopulmonary bypass time, cross-clamp time and operation time was respectively 143±92.2; 96.7±29 and 264.2±71.3 minutes. Twenty-four patients (41%) received a mitral prosthesis and 34 (70% of patients with native MV IE) received a mitral repair. In 3 (5%) cases a residual moderate mitral insufficiency (MI) was accepted. In 3 (5%) patients deterioration of neurocognitive function was found. One patient had conversion to full sternotomy due to pleural adhesions. Freedom from IE as well as reoperation was 100%.
Conclusions: Minimally invasive A-VV surgery is a safe and feasible option for active IE and valve repair can be achieved in a high percentage of patients. However, IE still remains a high-risk predictor for mortality and morbidity.
CMP36 Outcomes of Minimally Invasive versus Median Sternotomy in Patients Undergoing Double Valve Surgery
Maria J. Salas, Orlando Santana, Francisco Y. Macedo, Gerson Valdez, Gervasio Lamas, Joseph Lamelas. Mount Sinai Heart Institute, Miami Beach, FL USA.
Objective: We aimed to compare the outcomes of patients undergoing elective double valve surgery via a minimally invasive approach with those who had a standard median sternotomy.
Methods: We retrospectively reviewed all heart surgeries performed at our institution from December 2005 to December 2011, and identified 197 patients who underwent primary double-valve surgery. The outcomes of those who had minimally invasive valve surgery through a right minithoracotomy were compared with those who had a median sternotomy.
Results: Of the 197 patients, 117 (59%) underwent a minimally invasive approach, while 80 (41%) had a median sternotomy. The baseline characteristics were similar between the groups. The in-hospital mortality in the minimally invasive group was 2% (1/117) versus 10% (8/80) in the median sternotomy group, (p=0.009). The number of patients who received blood products was 83 (71%) in the minimally invasive group, and 78 (98%) in the median sternotomy group, p=<0.01. The median intensive care unit length of stay was 70 hours (IQR 46-135) in the minimally invasive group, and 114 (IQR 70-214) in the median sternotomy group, (p<0.001). The post-operative hospital length of stay was less in the minimally invasive group: 12 ± 12 days versus 18 ± 16 days, p=0.003. The post-operative complications were 66 (56%) in the minimally invasive group and 62 (78%) in the median sternotomy group, p=0.002; with the difference being driven by a reduction in the incidence of sepsis of 3 (2%) versus 9 (11%), p=0.01, and post-operative atrial fibrillation of 15 (13%) versus 24 (30%), p=0.003 in the minimally invasive group and the median sternotomy group, respectively.
Conclusions: A minimally invasive approach for patients undergoing double valve surgery reduces morbidity, mortality, and resource utilization when compared with median sternotomy.
CMP37 Minimally Invasive Approaches Converted in Full Sternotomy: What About Outcomes?
Francesca Chiaramonti, Andrea Farneti, Matteo Ferrarini, Stefano Bevilacqua, Antonio Miceli, Marco Solinas, Mattia Glauber. Heart Hospital G. Pasquinucci FTGM, Massa, Italy.
Objective: Current evidence suggests that minimally invasive approaches (MIA) in cardiac surgery may be associated with lower postoperative mortality and morbidity compared with conventional cardiac surgery (CCS). However, sometimes conversion to a full sternotomy can be required. We retrospectively reviewed patients who required intraoperative conversion during MIA.
Methods: Between January 2003 and February 2012, 1779 patients were planned for minimally invasive valve surgery. Forty-two patients (0.2%) required intraoperative conversion to a full sternotomy. Mean age was 68.7 +/- 12.7 years (range: 26 to 86 years), 22 patients were female (52%) and mean logistic EuroSCORE was 9.2 +/- 6.02%. The primary incision was a right anterior minithoracotomy in 37 patients (88%) and a ministernotomy in 5 patients (12%).
Results: Overall in-hospital mortality in MIA was 1.5%, while in patients required conversion was 14% (6/42). In these patients mean logistic EuroSCORE was 17.3+/- 7.2%. Mechanical ventilation time, ICU length of stay and postoperative in-hospital stay were respectively 21.02 +/- 18.20 (range 4-72) hours, 2.3 +/- 1.73 (range 1-7) days and 8.5 +/- 5.23 (range 3-26) days. In patients who died conversion occurred due to bleeding (n=3), acute ascending aorta dissection (n=1), refractory ventricular arrhythmia (n=1) and ventricular dysfunction (n=1).
Conclusions: Minimally invasive approaches in valve surgery are safe and feasible. In our experience conversion to full sternotomy occurred rarely during MIA and lead to death rarely, especially in high-risk patients. In most cases, it was due to intraoperative adverse events like ascending aorta dissection and ventricular dysfunction that can cause death also in CCS.©2013 by the International Society for Minimally Invasive Cardiothoracic Surgery