Over the last decade, the number of heart transplantations declined, and the number of implanted left ventricular assist devices (LVADs) markedly increased. This phenomenon is mainly driven by global organ shortage, especially in Western Europe, and groundbreaking developments in mechanical circulatory support.1–3 Heart failure remains the most common reason for hospital admission in the United States and Western Europe and therefore, it can be anticipated that number of LVAD implantations will further increase. To date, 100% of patients in need for destination therapy registered in the Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS), receive continuous-flow (CF) pumps.4,5 These miniaturized CF pumps improved outcome of patients with end-stage heart failure in terms of symptoms, hospitalization, and premature death while awaiting transplantation.6 With the increasing number of patients with implanted CF-LVAD systems, noncardiac procedures in those patients rise and present their own challenges, especially because of the necessary anticoagulation regimen.7,8 The two characteristic complications, hemorrhage and thrombosis, of CF pumps with consecutive morbidity and mortality are connected with this regimen.9 Although thrombotic complications of the LVAD system may be solved surgically, hemorrhage frequently leads to noncardiac interventions such as endoscopy or bladder catheterization.10,11 Accordingly, common intensive care interventions are complicated by early postoperative heparin bridging or already established phenprocoumon therapy and corresponding bleeding complications. One of those interventions is percutaneous dilatation tracheostomy (PDT). PDT is a standard procedure in critically ill patients and is utilized to avoid complications introduced by prolonged translaryngeal intubation in long-term mechanical ventilation.12 To date, no reports exist regarding outcomes of patients under phenprocoumon therapy with CF-LVADs and postoperative implemented PDT. In this work, we present our experience with PDT in LVAD patients with an emphasis on the anticoagulation regimen and corresponding periprocedural bleeding complications.
Materials and Methods
Between 2006 and 2015, PDT procedure was performed in 34 patients with prior LVAD implantation. Mean age was 50.3 ± 15.5 years, and 82.4% were male (28/34 patients). Written informed consent for PDT was routinely obtained from all preoperatively stable patients concomitantly to consent for index procedure before LVAD surgery. The Institutional Review Board approved anonymized data collection and analysis.
The medical records of all patients were analyzed retrospectively. Complications associated with the tracheostomy procedure were graded as major or minor as previously described.13
Major complications were defined as procedure-related death, cardiac arrest, acute hypotension requiring new or increased vasopressor support, acute hypoxemia, loss of airway, tracheal wall injury, false passage cannulation, pneumothorax, tracheostomy cannula obstruction, major bleeding (either stomal, intratracheal, or from tracheovascular fistula) causing hypoxemia or requiring emergency transfusion or open surgical repair, and tracheostomy-related sepsis (stoma infection as the only identifiable source).
Minor complications included localized minor bleeding, either stomal or intratracheal, which was defined as self-limiting bleeding or bleeding successfully treated with local compression, instillation of topical vasoconstrictive agents, or electrocauterization. In addition, localized subcutaneous emphysema without evidence of pneumothorax or pneumomediastinum and local stomal infections not causing sepsis were also classified as minor complications. Complications were followed up until successful decannulation, death or hospital discharge.
Detailed patient demographics and preprocedural data are summarized in Table 1.
Percutaneous Dilatation Tracheostomy Procedure
All patients in which PDT was performed presented with necessity for prolonged mechanical ventilation because of postoperative respiratory insufficiency. Because the administration of vitamin k antagonists from postoperative day 1 after LVAD implantation is the standard at our institution, all procedures were performed under already established phenprocoumon therapy with a mean International normalized ratio (INR) of 2.1 ± 0.9 and a mean partial thromboplastin time (PTT) of 68.9 ± 19.0 seconds. Heparin was administered in cases of inadequate INR values at postoperative day 3. Percutaneous dilatation tracheostomy was performed on postoperative day 9.5 ± 8.1.
For detailed periprocedural data, see Table 2.
For PDT procedures, at our specialized cardiac surgery intensive care unit, the Ciaglia Blue Rhino G2 Introducer set (Cook Medical Inc., Bloomington, IN) was utilized, and procedures were performed as previously described by Cantais et al.14 and Kluge et al.15: Patients were positioned with the neck hyperextended and intravenous analgosedation, and when necessary muscle relaxation, was administered. Under controlled translaryngeal ventilation, bronchoscopy was installed, and the patient was prepared and draped. Puncture of the trachea was performed between the first and second tracheal brace under bronchoscopic guidance, and a guide wire was placed into the main bronchus. Predilation was performed with the dilatator over the guidewire using the Seldinger technique. Then, the tracheal cannula was inserted, and after bronchoscopic confirmation of correct placement the guidance system was removed.
A total of 30 day and 1 year follow-up was completed in all patients. Data are presented as absolute numbers and percentages for categorical variables and mean values and standard deviation for continuous variables unless stated otherwise.
Reasons for LVAD implantation were dilative cardiomyopathy in 5/34 cases (14.7%), ischemic cardiomyopathy in 5/34 cases (14.7%), acute myocarditis in 5/34 cases (14.7%), myocardial infarction in 6/34 cases (17.6%), of which four patients suffered from a concomitant ventricular septal rupture and postoperative low output (postcardiotomy syndrome) in 13/34 cases (38.2%). LVADs implanted were Abiomed BVS 5000 (Abiomed Inc., Danvers, MA) in 4/34 patients (11.8%), Abiomed AB 5000 in 7/34 patients (20.6%), the Medos HIA-VAD (Medos AG, Stolberg, Germany) in 8/34 patients (23.5%), and the Heartware HVAD (Heartware Inc, Framingham, MA) in 15/43 patients (44.1%).
Intraprocedural success of PDT was achieved in all cases (34/34 patients) with sufficient placement of the tracheal tube and adequate mechanical ventilation. No retained secretions or tracheostomy tube obstructions were observed during follow-up. In no case, conversion to surgical tracheostomy was necessary. No serious bleeding complications that required urgent or emergent reoperation occurred during or after the PDT procedure. Two local stoma infections occurred during follow-up not causing sepsis or leading to the necessity of systemic antimicrobial therapy.
A total of 16 patients (47.1%) died within the first 30 days after LVAD implantation: 9/34 patients (26.4%) because of multiorgan failure, 2/34 patients (5.8%) because of sepsis, one patient (2.9 %) because of stroke, and 4/34 patients (11.7%) because of cardiac reasons, including two right ventricular failure and two ruptures of repaired ventricular septal defects. The tracheostomy tubes of the remaining 52.9% of patients were removed successfully. In these patients, no tracheal stenosis or wound healing complications were observed.
During the 1 year follow-up, 4/34 patients died. These patients were already weaned from mechanical ventilation. No deaths were associated with the PDT procedure.
30-day survival of the 15 HVAD patients in need for postoperative PDT alone was 66.6% (10/15 patients). For PDT outcome and follow-up data, see Table 3.
PDT in patients with mechanical circulatory support was described before.16 This is the first report describing outcomes of patients with LVAD under established phenprocoumon therapy and postoperative implemented PDT. Even if the mean INR was 2.1 ± 0.9 and the mean PTT 68.9 ± 19.0 seconds in our patients, we saw no intra- or periprocedural bleeding complications, which would be the main concern for this procedure. Also, no pump thrombosis occurred in this special patient cohort, most likely because of the early and sufficient implementation of phenprocoumon and heparin, respectively. Compared with other reports, which retrospectively analyzed outcomes of PDT in high-risk patients cohorts, the 30 day survival after PDT in LVAD patients with established phenprocoumon therapy is comparable.13 Despite the established anticoagulation regimen in our patients, complication rates were similar to the report of Gregoric et al.16 who performed PDT in LVAD patients without already administered phenprocoumon.
The advantages of PDT compared with surgical tracheostomy were extensively discussed17,18: low rates of cellulitis around the tracheostomy tube, low rates of peristomal infection rates, short procedure times, cost-effectiveness, and the possibility for a bedside intervention without the need for an operation suite. Especially, in critically ill patients like the herein described cohort, those advantages are substantial. Already minor infections can be potentially life-threatening in those patients, and sparing a potential transport to an operation room in critical ill patients is advantageous.19
Traditionally, elevated INR values and bleeding disorders are considered strict contraindications for PDT. We showed that under already established phenprocoumon therapy no bleeding complication occurred during or after the PDT. In our opinion, the avoidance of pump thrombosis and therefore very early administration of phenprocoumon is of higher importance, than the avoidance of potential bleeding complications, because of the more disastrous outcome of pump thrombosis.
Different to other reports,16 we strongly recommend the utilization of bronchoscopic guidance to ensure an adequate placement of the tube and recognize early potential intratracheal bleeding complications. During the 30 day follow-up, death occurred in 47.1% of the patients. This has to be substantially contributed to the preprocedural state of the herein described LVAD patients, requiring prolonged ventilatory support because of their severe cardiac disease and multiorgan dysfunction.
Compared with early generation LVAD systems, the HVAD system presented favorable early postinterventional outcome subsequent to PDT in terms of early postoperative survival. This, most likely, has to be attributed to multiple factors: mean INTERMACS level was lower in HVAD patients at time of implantation; postoperative mean INR was lower than in early generation pulsatile mechanical circulatory support at our center; and management of intra- and early postprocedural right ventricular failure differed substantially.
Typical limitations for a retrospective, single-center study with limited patient numbers apply: we analyzed data of only one center with a relatively small number of patients. Nevertheless, the herein presented patient numbers are higher than so far reported for this highly specialized patient population. Therefore, the information included should be helpful for intensivists, cardiac surgeons, and anesthesiologists treating patients with mechanical circulatory support and subsequent oral anticoagulation.
PDT is a safe procedure for patients with an implanted LVAD, established phenprocoumon therapy and respiratory insufficiency at intensive care units. It is not connected with bleeding complications and shows a good procedural outcome. Experienced intensivists and an interdisciplinary approach at a specialized cardiac surgery intensive care unit should be mandatory to provide best patient care in this highly special patient cohort and guarantee good outcomes.
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