Advanced Heart Failure Treated With Continuous-Flow Left Ventricular Assist Device - HeartMate II study

Nov 17, 2009
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Author/Summarized by Author:
Anthony A. Bavry, MD, MPH, FACC
Summary Reviewer:
Deepak L. Bhatt, MD, MPH, MBA, FACC
Trial Sponsor:
Thoratec
Date Presented:
01/01/2009
Date Published:
01/01/2009
Date Updated:
11/17/2009
Original Posted Date:
11/17/2009
References

Description:

The goal of this trial was to compare treatment with a continuous-flow HeartMate II ventricular assist device compared with a pulsatile-flow HeartMate XVE ventricular assist device among patients with advanced heart failure not eligible for heart transplantation.

Hypothesis:

Continuous-flow left ventricular assist device would be superior at reducing adverse events and improving functional capacity.

Study Design

  • Randomized
  • Parallel
  • Stratified

Patients Enrolled: 200
Mean Follow Up: 2 years
Mean Patient Age: 62 years
Female: 19%
Mean Ejection Fraction: 17%

Patient Populations:

  • Left ventricular ejection fraction <25%
  • Peak oxygen consumption <14 ml per kg body weight per minute or <50% of predicted value
  • New York Heart Association class III or IV for at least 45 days
  • Use of an intra-aortic balloon pump for at least 7 days or inotropes for at least 14 days

Exclusions:

  • Irreversible renal, liver, or pulmonary disease

Primary Endpoints:

  • Survival free from disabling stroke or reoperation to repair/replace the device

Secondary Endpoints:

  • Survival
  • Adverse events
  • Functional capacity
  • Quality of life

Drug/Procedures Used:

Patients with advanced heart failure who were ineligible for heart transplantation were randomized to a continuous-flow ventricular assist device (n = 134) versus a pulsatile-flow ventricular assist device (n = 66).

Concomitant Medications:

Aspirin was recommended for all patients. Warfarin was recommened for patients with a continuous-flow device.

Principal Findings:

Overall, 200 patients were randomized. In the continuous-flow group, the mean age was 62 years, 19% were women, 66% had ischemia as the cause of heart failure, mean cardiac index was 2.0 L/min/m2, pulmonary capillary wedge pressure was 24 mm Hg, mean serum creatinine was 1.6 mg/dl, and history of stroke was 16%. The use of an inotropic agent was 77% and intra-aortic balloon pump was 22%.

The primary outcome, survival free from stroke or reoperation to repair/replace the assist device was 46% in the continuous-flow group versus 11% in the pulsatile-flow group (p < 0.001). Disabling stroke was 11% versus 12%, reoperation to repair/replace the assist device was 10% versus 36% (p < 0.001), and death within 2 years was 33% versus 41% (p = 0.048). Rehospitalization was reduced 38% with the continuous-flow device. Functional class I or II at 12 months was 76% versus 61% (p = 0.22), respectively.

Interpretation:

Among patients with advanced heart failure ineligible for heart transplantation, the use of a continuous-flow left ventricular assist device was beneficial. This device improved freedom from disabling stroke or reoperation for device repair/replacement. This outcome was driven by a reduced need for reoperation with the continuous-flow device. Also, rehospitalization and mortality were reduced and functional capacity was improved. This device may become an alternative for some patients as destination therapy.

References:

Slaughter MS, Rogers JG, Milano CA, et al. Advanced heart failure treated with continuous-flow left ventricular assist device. N Engl J Med 2009;Nov 17:[Epub ahead of print].

Presented by Dr. Joseph Rogers at the American Heart Association Scientific Sessions, Orlando, FL, November 17, 2009.

Keywords: Stroke, Pulmonary Wedge Pressure, Reoperation, Oxygen Consumption, Heart-Assist Devices, Heart Failure, Stroke Volume, Creatinine, Heart Transplantation


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