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Clinical Trial
. 2009 Jul 21;54(4):312-21.
doi: 10.1016/j.jacc.2009.03.055.

Extended mechanical circulatory support with a continuous-flow rotary left ventricular assist device

Francis D Pagani  1 , Leslie W Miller, Stuart D Russell, Keith D Aaronson, Ranjit John, Andrew J Boyle, John V Conte, Roberta C Bogaev, Thomas E MacGillivray, Yoshifumi Naka, Donna Mancini, H Todd Massey, Leway Chen, Charles T Klodell, Juan M Aranda, Nader Moazami, Gregory A Ewald, David J Farrar, O Howard Frazier; HeartMate II Investigators
Affiliations
Free article
Clinical Trial

Extended mechanical circulatory support with a continuous-flow rotary left ventricular assist device

Francis D Pagani et al. J Am Coll Cardiol. .
Free article

Abstract

Objectives: This study sought to evaluate the use of a continuous-flow rotary left ventricular assist device (LVAD) as a bridge to heart transplantation.

Background: LVAD therapy is an established treatment modality for patients with advanced heart failure. Pulsatile LVADs have limitations in design precluding their use for extended support. Continuous-flow rotary LVADs represent an innovative design with potential for small size and greater reliability by simplification of the pumping mechanism.

Methods: In a prospective, multicenter study, 281 patients urgently listed (United Network of Organ Sharing status 1A or 1B) for heart transplantation underwent implantation of a continuous-flow LVAD. Survival and transplantation rates were assessed at 18 months. Patients were assessed for adverse events throughout the study and for quality of life, functional status, and organ function for 6 months.

Results: Of 281 patients, 222 (79%) underwent transplantation, LVAD removal for cardiac recovery, or had ongoing LVAD support at 18-month follow-up. Actuarial survival on support was 72% (95% confidence interval: 65% to 79%) at 18 months. At 6 months, there were significant improvements in functional status and 6-min walk test (from 0% to 83% of patients in New York Heart Association functional class I or II and from 13% to 89% of patients completing a 6-min walk test) and in quality of life (mean values improved 41% with Minnesota Living With Heart Failure and 75% with Kansas City Cardiomyopathy questionnaires). Major adverse events included bleeding, stroke, right heart failure, and percutaneous lead infection. Pump thrombosis occurred in 4 patients.

Conclusions: A continuous-flow LVAD provides effective hemodynamic support for at least 18 months in patients awaiting transplantation, with improved functional status and quality of life. (Thoratec HeartMate II Left Ventricular Assist System [LVAS] for Bridge to Cardiac Transplantation; NCT00121472).

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