"Comparison of Continuous-Flow and Pulsatile-Flow Left Ventricular Assist Devices in Advanced Heart Failure". The New England Journal of Medicine. 2009. 361:2241-2251. PubMed
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Does a continuous-flow left ventricular assist device (LVAD) improve survival free from disabling stroke and reoperation to repair or replace the device in patients with advanced heart failure compared to a pulsatile-flow LVAD?
Treatment with a continuous-flow LVAD in patients with advanced heart failure significantly improved the probability of survival free from stroke and device failure at 2 years compared with a pulsatile-flow device. Both devices significantly improved the quality of life and functional capacity.
Advances in mechanical circulatory support devices, particularly the development of continuous-flow left ventricular assist devices (LVADs), have offered alternative treatment options for patients with advanced heart failure ineligible for transplantation. This randomized trial demonstrated that continuous-flow LVADs provided a survival benefit with a more favorable adverse event profile compared to conventional pulsatile-flow LVADs.
As of the last knowledge update, guidelines highlight LVADs as potential therapy options for select patients with advanced heart failure, emphasizing patient selection and management to maximize benefits and reduce risks associated with device therapy.
- Multicenter, randomized, controlled trial - N=200 adult patients with advanced heart failure - Continuous-flow LVAD (n=134) - Pulsatile-flow LVAD (n=66) - Setting: 38 centers in the United States - Enrollment: March 2005 to May 2007 - Mean follow-up: 2 years - Analysis: Intention-to-treat - Primary outcome: Survival at 2 years free from disabling stroke or reoperation to repair or replace the device
- Inclusion Criteria: Advanced heart failure, LVEF <25%, peak oxygen consumption <14 ml/kg/min or <50% predicted, NYHA class IIIB/IV symptoms for most of the past 60 days, or reliant on an intraaortic balloon pump for 7 days or inotropes for 14 days prior to enrollment - Exclusion Criteria: Irreversible severe renal, pulmonary, or hepatic dysfunction, active infection - Baseline characteristics: Median age 64 years, mean LVEF 17%, ~80% receiving intravenous inotropic agents, ~20% with intraaortic balloon pump at enrollment
- Patients were randomized to receive either a continuous-flow LVAD (HeartMate II) or a pulsatile-flow LVAD (HeartMate XVE). - Anti-thrombotic management included aspirin for all patients and warfarin for continuous-flow LVAD, targeting INR of 2.0 to 3.0.
- Primary Outcome: 46% with continuous-flow device vs. 11% with pulsatile-flow device (P<0.001; hazard ratio 0.38; 95% CI, 0.27 to 0.54) - Secondary Outcomes: 2-year actuarial survival 58% with continuous-flow vs. 24% with pulsatile-flow (P=0.008); quality of life and functional capacity improved significantly in both groups - Major adverse events (per patient-year): - Device-related infection: Continuous-flow 0.07, pulsatile-flow 0.17 - Non–device-related infection: Continuous-flow 0.25, pulsatile-flow 0.67 - Right heart failure: Continuous-flow 0.10, pulsatile-flow 0.18 - Rehospitalization rate was reduced by 38% with continuous-flow vs pulsatile-flow devices.
- Single-device manufacturer funded and conducted the trial, which may introduce bias. - Open-label design may affect patient-reported outcomes, such as functional abilities and quality of life. - Limited generalizability as the trial was performed in a selected patient population.
The trial was funded by Thoratec.
- Slaughter, M.S., et al., "Advanced Heart Failure Treated with Continuous-Flow Left Ventricular Assist Device", New England Journal of Medicine, 2009. - ClinicalTrials.gov number, NCT00121485.