HeartMate Left Ventricular Assist Device as Bridge to Heart Transplantation

Background. Because of the limited supply of donor hearts, prospective recipients continue to die while on the waiting list for heart transplantation. Use of long-term mechanical circulatory support devices as a bridge to transplantation may reduce this mortality. However, with the present state of technology, continued clinical evaluation of the various long-term, mechanical circulatory support devices available is mandatory.

Methods. Sixteen patients were bridged with the HeartMate left ventricular assist device (LVAD) to heart transplantation for New York Heart Association functional class IV cardiac failure. Twelve pneumatic and six electric devices were used. The mean cardiac index and the mean pulmonary vascular resistance of the patient cohort were 1.7 1 · min⁻¹ · m⁻² and 3.1 Wood units, respectively.

Results. The mean LVAD support time per transplanted patient was 237 days, with a cumulative LVAD support time of about 7.2 years. Bleeding was the main operative and postoperative complication. Two patients suffered from neurologic complications and there were two major incidents of device malfunction. Twelve patients (75%) now have received a transplant, 3 (19%) are awaiting a transplant, and in 1 patient (6%), the device was explanted after spontaneous left ventricular recovery. Eleven of the 12 patients who received a transplant are alive and doing well. The HeartMate LVAD gave adequate circulatory support over extended periods of time and reversed the vital organ dysfunction. Since the start of the LVAD program, only 1 patient has died on our heart transplantation waiting list, compared to nine deaths in the 2 preceding years.

Conclusions. The HeartMate LVAD bridge to heart transplantation can be performed with low post-LVAD implantation and posttransplantation mortality and offers 1- and 2-year posttransplantation actuarial survival rates comparable to those for nonbridged heart transplant recipients.     

Outcomes in Patients With HeartMate3 Versus HeartWare Ventricular Assist Device Implanted as Destination Therapy

BackgroundDonor organ shortage caused a growing interest in mechanical circulatory support not only as a bridge to transplant but also as a destination therapy. Improved results and increased applicability and durability of left ventricular assist devices (LVADs) have established this treatment option as an alternative for patients with end-stage heart failure.MethodsThe aim of the study was to compare the early results, major complications, and the follow up of all patients undergoing HeartMate3 (HM3) LVAD and HeartWare Ventricular Assist Device (HVAD) system implantation in one of the most experienced Clinic in Poland between 2015 and 2020.ResultsThere were 78 individuals (72 male, 92%; 6 female, 8%), with median age 57 years (range, 50-62 years). Until 2020 we implanted 47 (60%) HVADs and 31 (40%) HM3 LVADs. Patient characteristics were comparable between both groups apart from median left ventricle diameter (8.2 cm [range, 7.4-8.4 cm] in HM3 group vs 7.2 cm [range, 6.7-7.9 cm] in HVAD group; P < .01) The overall survival was 53.2% in the HVAD group and 77.4% in the HM3 group (P =.03). Mean survival time was higher in HM3 group (2.97 years [range, 2.43-3.5 years] vs 2.51 years [range, 1.94-3.08 years]; P < .05). Mean complication-free survival time was also higher in the HM3 group (2.16 years [range, 1.55-2.76] vs 1.61 [range, 1.16-2.06 years]; P < .05), with overall complication-free rate of 54.8% for HM3 vs 29.8% for HVAD (P = .27). Median hospitalization time was comparable (31 days [range, 25-39 days] in the HM3 group vs 32 days [range, 24-38 days] in the HVAD group; P = .49).ConclusionsPatients supported with the HM3 had significantly fewer major complications than HVAD. Moreover, the HVAD was associated with higher mortality.     

Bridge to Heart Transplantation with Left Ventricular Assist Device Versus Inotropic Agents in Status 1 Patients

Abstract   Objective: Left ventricular assist devices (LVADs) are commonly used for critically ill patients awaiting heart transplantation, although their effect on long-term outcomes, relative to inotropic support alone, is still debated. Method: Data from Status 1 patients who underwent heart transplantation at our institution between 1990 and 2005 were reviewed (n = 180). They were divided into two groups: those who underwent LVAD implantation as a bridge to transplant (n = 31) and those treated with inotropic agents without the support of LVAD (n = 149). They were compared in terms of demographics and clinical outcome. Results: Both groups were similar in terms of patient and donor demographics. Relative to the inotrope group, the LVAD group did have a longer ischemic time (p = 0.032), a greater incidence of pretransplant transfusion (p < 0.00001), and a greater maximum level of pretransplant panel reactive antibodies (p < 0.001). Creatinine at listing significantly improved in LVAD patients awaiting transplantation (p < 0.0001). Comparisons of 5-year survival in addition to freedom from posttransplant infection, malignancy, revascularization, and acute rejection did not show significant difference between the two groups. The LVAD group did benefit from increased freedom from chronic rejection compared to the inotrope group (p = 0.049). Stepwise Cox Regression did not identify any independent factors affecting patient survival during the first 5 years after transplant. Conclusions: Status 1 patients successfully bridged to heart transplantation with LVADs had similar long-term clinical outcomes compared to those treated with inotropic agents.     

Outcomes With Ventricular Assist Device Versus Extracorporeal Membrane Oxygenation as a Bridge to Pediatric Heart Transplantation

Extracorporeal membrane oxygenation (ECMO) has long been the sole means of mechanical support for pediatric patients with end‐stage cardiac failure, but has a high waitlist mortality and a reported survival to hospital discharge of less than 50%. The purpose of this study was to compare waitlist mortality and survival for ECMO versus ventricular assist device (VAD) support. A review was conducted of all patients listed for heart transplantation (HTx) since 2002 and requiring mechanical support. VAD support has been available from 2004 (Berlin Heart Excor Pediatrics). Competing risks analysis was used to model survival to one of four outcomes (HTx, death on waitlist, delisting, improvement). Thirty‐six patients were on mechanical support while awaiting HTx (21 ECMO, 12 VAD, three both). Median age at listing was 1.2 years (birth–16.6 years) for ECMO and 11.3 years (0.3–14.6 years) for VAD. Diagnosis was cardiomyopathy in 33% for ECMO and 93% for VAD. Median time to HTx was 37 days (1–930) overall, 20 days (1–85) for ECMO, and 39 days (5–108) for VAD. Mechanical support was associated with increased odds of HTx (hazard ratio [HR] 2.4 [1.7–3.3], P < 0.0001) but also delisting or death waiting (HR 3.0 [1.1–7.8], P = 0.03). Waitlist mortality of 38% on ECMO was reduced to 13% with VAD use. Survival post‐HTx to hospital discharge was better in the group on VAD support (92 vs. 80%). Pediatric patients requiring mechanical support as a bridge to HTx have short wait times but high waitlist mortality. Those patients who survived to be put on the Berlin Heart Excor Pediatric device based on individualized clinical decision making then had a lower waitlist mortality, a longer duration of support, and a higher survival to transplantation and hospital discharge.     

Clinical Outcomes of Patients With the HeartMate II Left Ventricular Assist Device: A Single-center Experience From Japan

Background

Left ventricular assist device (LVAD) therapy is the “gold standard” alternative therapy for patients with advanced heart failure. However, LVAD therapy is still uncommon in the Asia-Pacific region. Therefore, we aimed to elucidate the clinical outcomes of patients from Japan supported with the HeartMate II (HM-II) LVAD at our institution.

Single‐Center Experience With HeartMate II Left Ventricular Assist Device Explantation

In patients with continuous flow left ventricular assist devices (CF‐LVADs) myocardial recovery is uncommon. Given the heterogeneity of the population implanted and low incidence of recovery, the discovery of native left ventricular (LV) recovery and criteria for explantation of CF‐LVAD system is not clearly determined. We sought to analyze the characteristics of the patients who underwent CF‐LVAD explantation at our institution. Prospectively collected data on patients supported with CF‐LVADs were reviewed retrospectively. Patients who underwent CF‐LVAD explants were identified and their characteristics were analyzed with a focus on patient presentation and determinants of explantability. From November 2006 to June 2014, 223 patients (181 male, 42 female) underwent implantation of HeartMate II LVAD. Seven female (16.7%) and one male (0.6%) patients were explanted (P < 0.001). Mean age was 43 ± 9 years and etiology for cardiomyopathy was ischemic in three (37.5%) patients, nonischemic in four (50%) patients, and mixed in the one (12.5%) male patient of the cohort. Five (62.5%) patients presented acutely with significant hemolysis, and were found to have LV improvement as well as reduced, absent, or reversed diastolic flow velocities on echocardiography. Overall, mean lactate dehydrogenase level before explantation was 1709 ± 1168 U/L compared to the mean baseline level of 601 ± 316 U/L (P = 0.048). Mean LV ejection fraction (LVEF) improved from 17 ± 7% preimplant to 56 ± 11% pre‐explantation (P < 0.001). Median number of days on CF‐LVAD support was 870 (interquartile range, 209–975) while mean duration of follow‐up after the CF‐LVAD explantation was 276 ± 240 days. Mean LVEF dropped from 46 ± 19% postexplantation to 34 ± 10% during the most recent follow‐up (P = 0.015). At our institution, patients who underwent LVAD explants were predominantly women with nonischemic cardiomyopathy. Clinical evidence of hemolysis and echocardiographic evidence of reduced or absent diastolic flow velocities were common findings in these patients. Over time, patient's native LV function declined in the absence of LVAD (after LVAD explantation). Significant challenges remain in predicting LV recovery and identifying those individuals who have recovered myocardial function significant enough to be explanted.