Use of a Continuous-Flow Device in Patients Awaiting Heart Transplantation

TLDR

Left ventricular assist devices are an accepted therapy for refractory heart failure, but pulsatile volume‑displacement devices are limited by large size and poor long‑term durability, hindering widespread adoption. This prospective multicenter study implanted continuous‑flow left ventricular assist devices in 133 end‑stage heart failure patients awaiting transplantation to evaluate their effectiveness. The investigators assessed 180‑day outcomes of transplantation, cardiac recovery, or continued support, and measured functional status and quality of life. At 180 days, 75% of patients had undergone transplantation, recovered, or remained supported; median support was 126 days with 75% 6‑month and 68% 12‑month survival, significant improvements in NYHA class, 6‑min walk, and QoL scores, but major adverse events—including bleeding, stroke, right heart failure, infection, and two pump thromboses—occurred. The trial is registered under ClinicalTrials.gov NCT00121472.

Abstract

The use of left ventricular assist devices is an accepted therapy for patients with refractory heart failure, but current pulsatile volume-displacement devices have limitations (including large pump size and limited long-term mechanical durability) that have reduced widespread adoption of this technology. Continuous-flow pumps are newer types of left ventricular assist devices developed to overcome some of these limitations.In a prospective, multicenter study without a concurrent control group, 133 patients with end-stage heart failure who were on a waiting list for heart transplantation underwent implantation of a continuous-flow pump. The principal outcomes were the proportions of patients who, at 180 days, had undergone transplantation, had cardiac recovery, or had ongoing mechanical support while remaining eligible for transplantation. We also assessed functional status and quality of life.The principal outcomes occurred in 100 patients (75%). The median duration of support was 126 days (range, 1 to 600). The survival rate during support was 75% at 6 months and 68% at 12 months. At 3 months, therapy was associated with significant improvement in functional status (according to the New York Heart Association class and results of a 6-minute walk test) and in quality of life (according to the Minnesota Living with Heart Failure and Kansas City Cardiomyopathy questionnaires). Major adverse events included postoperative bleeding, stroke, right heart failure, and percutaneous lead infection. Pump thrombosis occurred in two patients.A continuous-flow left ventricular assist device can provide effective hemodynamic support for a period of at least 6 months in patients awaiting heart transplantation, with improved functional status and quality of life. (ClinicalTrials.gov number, NCT00121472 [ClinicalTrials.gov]. ).