Left Ventricular Assist Device Implantation and Concomitant Dor Procedure: a Single Center Experience.

OBJECTIVE: Left ventricular assist device (LVAD) implantation with concomitant Dor plasty is only reported anecdotally. We herein aimed to describe our experience with LVAD and concomitant Dor procedures and describe long-term outcomes of this special subset of heart failure patients. METHODS: Between January/2010 and December/2018, 144 patients received LVAD therapy at our institution. Of those, five patients (80% male, 60.4±7.2 years) presented with an apical aneurysm and received concomitant Dor plasty. Apical aneurysms presented diameter between 75 and 98 mm, with one impending rupture. RESULTS: Procedural success was achieved in all patients. No unplanned right ventricular assist device implantation occurred. Furthermore, no acute 30-day mortality was seen. In follow-up, one patient was lost due to intentional disconnection of the driveline. One patient underwent heart transplantation on postoperative day 630. The remaining three patients are still on device with sufficient flow; pump thromboses were successfully managed by lysis therapy in one patient. CONCLUSION: LVAD implantation with concomitant Dor procedure is feasible, safe, and occasionally performed in patients with ischemic cardiomyopathy. Major advantages are prevention of thromboembolism and facilitation of LVAD placement by improving pump stability and warranting midventricular, coaxial alignment of the inflow cannula. In long-term follow-up, no adverse event associated with Dor plasty was observed.

Rationale and design of the DIGIT-HF trial (DIGitoxin to Improve ouTcomes in patients with advanced chronic Heart Failure): a randomized, double-blind, placebo-controlled study.

AIMS: Despite recent advances in the treatment of chronic heart failure (HF), mortality and hospitalizations still remain high. Additional therapies to improve mortality and morbidity are urgently needed. The efficacy of cardiac glycosides - although regularly used for HF treatment - remains unclear. DIGIT-HF was designed to demonstrate that digitoxin on top of standard of care treatment improves mortality and morbidity in patients with HF and a reduced ejection fraction (HFrEF). METHODS: Patients with chronic HF, New York Heart Association (NYHA) functional class III-IV and left ventricular ejection fraction (LVEF) ≤ 40%, or patients in NYHA functional class II and LVEF ≤ 30% are randomized 1:1 in a double-blind fashion to treatment with digitoxin (target serum concentration 8-18 ng/mL) or matching placebo. Randomization is stratified by centre, sex, NYHA functional class (II, III, or IV), atrial fibrillation, and treatment with cardiac glycosides at baseline. A total of 2190 eligible patients will be included in this clinical trial (1095 per group). All patients receive standard of care treatment recommended by expert guidelines upon discretion of the treating physician. The primary outcome is a composite of all-cause mortality or hospital admission for worsening HF (whatever occurs first). Key secondary endpoints are all-cause mortality, hospital admission for worsening HF, and recurrent hospital admission for worsening HF. CONCLUSION: The DIGIT-HF trial will provide important evidence, whether the cardiac glycoside digitoxin reduces the risk for all-cause mortality and/or hospital admission for worsening HF in patients with advanced chronic HFrEF on top of standard of care treatment.

Stentless vs. stented bioprosthesis for aortic valve replacement: A case matched comparison of long-term follow-up and subgroup analysis of patients with native valve endocarditis.

BACKGROUND: Current retrospective evidence suggests similar clinical and superior hemodynamic outcomes of the Sorin Freedom Solo stentless aortic valve (SFS) (LivaNova PLC, London, UK) compared to the Carpentier Edwards Perimount stented aortic valve (CEP) (Edwards Lifesciences Inc., Irvine, California, USA). To date, no reports exist describing case-matched long-term outcomes and analysis for treatment of native valve endocarditis (NVE). METHODS: From 2004 through 2014, 77 consecutive patients (study group, 59.7% male, 68.9 ± 12.5 years, logEuroSCORE II 7.6 ± 12.3%) received surgical aortic valve replacement (SAVR) with the SFS. A control group of patients after SAVR with the CEP was retrieved from our database and matched to the study group regarding 15 parameters including preoperative endocarditis. Acute perioperative outcomes and follow-up data (mean follow-up time 48.7±29.8 months, 95% complete) were retrospectively analyzed. RESULTS: No differences in early mortality occurred during 30-day follow up (3/77; 3.9% vs. 4/77; 5.2%; p = 0.699). Echocardiographic findings revealed lower postprocedural transvalvular pressure gradients (max. 17.0 ± 8.2 vs. 24.5 ± 9.2 mmHg, p< 0.001/ mean pressure of 8.4 ± 4.1 vs. 13.1 ± 5.9 mmHg, p< 0.001) in the SFS group. Structural valve degeneration (SVD) (5.2% vs. 0%; p = 0.04) and valve explantation due to SVD or prosthetic valve endocarditis (PVE) (9.1% vs. 1.3%; p = 0.04) was more frequent in the SFS group. All-cause mortality during follow-up was 20.8% vs. 14.3% (p = 0.397). When patients were divided into subgroups of NVE and respective utilized bioprosthesis, the SFS presented impaired outcomes regarding mortality in NVE cases (p = 0.031). CONCLUSIONS: The hemodynamic superiority of the SFS was confirmed in this comparison. However, clinical outcomes in terms of SVD and PVE rates, as well as survival after NVE, were inferior in this study. Therefore, we are reluctant to recommend utilization of the SFS for treatment of NVE.

Outcomes of Minimally Invasive Temporary Right Ventricular Assist Device Support for Acute Right Ventricular Failure During Minimally Invasive Left Ventricular Assist Device Implantation.

Right ventricular failure (RVF) may still occur despite the benefits of minimally invasive left ventricular assist device (MI-LVAD) implantation. Our center strategy aims to avoid aggressive postoperative inotrope use by using mechanical support to facilitate right ventricle recovery and adaptation. We herein report first outcomes of patients with minimally invasive temporary right ventricular assist device (MI-t-RVAD) support for RVF during MI-LVAD implantation. Right ventricular failure was defined as requiring more than moderate inotopic support after weaning from cardiopulmonary bypass according to Interagency Registry for Mechanically Assisted Circulatory Support adverse event definitions. All patients requiring MI-t-RVAD support for RVF during MI-LVAD implantation between January, 2012 and April, 2016 were retrospectively reviewed. Clinical endpoints were death or unsuccessful RVAD weaning. Overall 10 patients (90% male, mean age 49.6 ± 14.8 years) underwent MI-t-RVAD implantation. Duration of MI-t-RVAD support was 16.2 ± 11.6 days. Right ventricular assist device weaning and subsequent uneventful awake device explantation was successful in all cases. The 30 day survival was 80%. Our results confirm safety and feasibility of MI-t-RVAD support for acute RVF in the setting of MI-LVAD implantation. The potential benefits of this strategy are more stable hemodynamics in the first postoperative days that usually are crucial for LVAD patients and reduced inotrope requirement.

Percutaneous Dilatation Tracheostomy in Patients with Left Ventricular Assist Device and Established Phenprocoumon Therapy.

Over the last decade, the number of heart transplantations declined, and the number of implanted left ventricular assist devices (LVADs) markedly increased. Accordingly, common intensive care interventions rise and present their own challenges, especially because of the necessary anticoagulation regimen. One of these procedures is percutaneous dilatation tracheostomy (PDT). We herein report our experience with 34 patients with LVAD and established phenprocoumon therapy (International normalized ratio 2.1 ± 0.9, partial thromboplastin time 68.9 ± 19.0 seconds) who underwent PDT between 2006 and 2015 at our specialized cardiac surgery intensive care unit. Intraprocedural success 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. A total of 16 patients (47.1%) died within the first 30 days after LVAD implantation. This is the first report describing outcomes of patients with LVAD under established phenprocoumon therapy and postoperative implemented PDT. PDT is a safe procedure for those patients. It is not connected with bleeding complications and shows a good procedural outcome.

Left ventricular assist device implantation and concomitant dor procedure: a single center experience

Abstract Objective: Left ventricular assist device (LVAD) implantation with concomitant Dor plasty is only reported anecdotally. We herein aimed to describe our experience with LVAD and concomitant Dor procedures and describe long-term outcomes of this special subset of heart failure patients. Methods: Between January/2010 and December/2018, 144 patients received LVAD therapy at our institution. Of those, five patients (80% male, 60.4±7.2 years) presented with an apical aneurysm and received concomitant Dor plasty. Apical aneurysms presented diameter between 75 and 98 mm, with one impending rupture. Results: Procedural success was achieved in all patients. No unplanned right ventricular assist device implantation occurred. Furthermore, no acute 30-day mortality was seen. In follow-up, one patient was lost due to intentional disconnection of the driveline. One patient underwent heart transplantation on postoperative day 630. The remaining three patients are still on device with sufficient flow; pump thromboses were successfully managed by lysis therapy in one patient. Conclusion: LVAD implantation with concomitant Dor procedure is feasible, safe, and occasionally performed in patients with ischemic cardiomyopathy. Major advantages are prevention of thromboembolism and facilitation of LVAD placement by improving pump stability and warranting midventricular, coaxial alignment of the inflow cannula. In long-term follow-up, no adverse event associated with Dor plasty was observed.