Outcomes and hemodynamics of Enable bioprosthesis in 432 patients: an afterword.

AIMS: To report the largest single-center experience in surgical aortic valve replacement (SAVR) using the Enable sutureless bioprosthesis concerning the clinical outcome and hemodynamic behavior. MATERIAL AND METHODS: From April 2010 to May 2017, a total of 432 patients (36.3% of them women) received the Enable sutureless prosthesis for aortic valve stenosis, regurgitation, and/or endocarditis. The endpoints were overall survival after operation for 30 days and adverse events. RESULTS: No intraoperative complications occurred; intraoperative mortality was 0%. The 30-day mortality rate was 3.5% overall and 0.9% for isolated procedure. No valve-related deaths were observed. There was a need for prosthesis replacement during the early postoperative period in eight patients (1.9%): seven patients (1.6%) had a significant paravalvular leak and one patient (0.2%) developed early postoperative endocarditis. The maximum and mean pressure gradients across the prosthesis were 19.2 ± 7.1 mmHg and 11.1 ± 4.6 mmHg, respectively. A permanent pacemaker was necessary in 6.5% of the patients. CONCLUSIONS: The Enable sutureless prosthesis showed a reliable clinical outcome with low perioperative mortality and morbidity. The hemodynamic performance was satisfactory. Our data confirmed the safety of SAVR using the Enable bioprosthesis. However, a higher rate of pacemaker implantation (6.5%) has to be mentioned.

Clinical Outcome and Comparison of Three Different Left Ventricular Assist Devices in a High-Risk Cohort.

We present a comparison between three left ventricular assist devices (LVADs): HeartWare (HVAD) (HeartWare International Inc., Framingham, MA, USA), HeartMate II (HMII) and HeartMate III (HMIII) (Thoratec Corp., Pleasanton, CA, USA). To our knowledge, no study to date has aimed at placing these three devices in juxtaposition. Between June 2007 and June 2017, 108 consecutive patients received HMII, n = 77 (71.3%), HVAD, n = 14 (13%), or HM III, n = 17 (15.7%), for end-stage heart failure. Mean age was 63.8 ± 11.2 years (range 24-84 years), with median INTERMACS profile of 3. Preoperatively, 26 patients (24.1%) were ventilated, 17 patients (15.7%) had an intraaortic balloon pump, and 27 patients (25%) were on extracorporeal life support. Overall survival at 30 days was 70.4%, at 1 year 51.9%, and at 5 years 38% with no significant difference in survival between HMII, HVAD, and HMIII. Median cardiopulmonary bypass time was 113 min (range 50-371 min). Two patients received a minimally-invasive procedure. Most common adverse events were revision for bleeding (42.6%), tracheotomy (33.3%), acute kidney failure with new-onset dialysis (25%), sepsis (17.6%), and gastrointestinal bleeding (10.2%). The average duration of follow-up was 1.52 ± 2.11 years (range 0-7.95 years). The median number of readmissions was 2 (range 0-23), the median length of hospital stay as readmission was 17 days (range 0-158 days). Strong predictors of overall mortality (P < 0.05) were postoperative sepsis (OR = 5.729, 95%CI = 3.001-10.937), intraoperative/postoperative need for right ventricular mechanical support (OR = 5.232, 95%CI = 3.008-9.102), preoperative extracorporeal life support (OR = 2.980, 95%CI = 1.615-5.500), readmission because of suboptimal INR value (OR = 2.748, 95%CI = 1.045-7.226), need of inotropes over 7 days postoperatively (OR = 2.556, 95%CI = 1.432-4.562), new onset of temporary hemodialysis postoperatively (OR = 1.986, 95%CI = 1.084-3.635), and female gender (OR = 1.955, 95%CI = 1.062-3.598). No significant difference in mortality between HMII, HVAD, and HMIII was observed. The following predictors of overall mortality were identified (P < 0.05): postoperative sepsis, need for perioperative mechanical support, readmission because of suboptimal INR value, new onset of temporary hemodialysis postoperatively and female gender.