By Deborah Brauser
ORLANDO, Fla -- November 23, 2009 -- A new, continuous-flow heart pump, or left ventricular assist device, (CF-LVAD), improves survival for patients with advanced heart failure more than the currently approved pulsatile-flow model (PF-LVAD), according to a study presented here at the American Heart Association (AHA) Scientific Sessions 2009.
The results of the HeartMate II Destination Therapy Trial were presented here on November 17 during a Late-Breaking Clinical Trial session.
"The new [CF-LVADs] have significant advantages including a smaller size and superior durability, and it operates quietly," said Joseph G. Rogers, MD, Duke Heart Failure Program at Duke University Medical Center, Durham, North Carolina. "It also pumps blood continuously, which reduces the systolic blood pressure."
According to Dr. Rogers, patients diagnosed with advanced heart failure treated with optimal medical therapy have a 10%-20% survival rate in the ensuing years.
Therefore, the primary endpoint for this study was "survival free from disabling stroke and device failure requiring reoperation at 2 years," according to Dr. Rogers. Overall survival and functional capacity were secondary outcomes.
A total of 200 patients (median age, 64 years; 85% male) ineligible for heart transplantation were enrolled at 38 medical centres in the United States from March 2005 to May 2007. They were randomised 2:1 to receive either a CF-LVAD (n = 134) or PF-LVAD (n = 66).
Results showed that the number of CF-LVAD patients who reached the composite primary endpoint was significantly greater than the PF-LVAD patients (46% vs 11%; P < .001).
The patients who received the CF-LVAD also had greater overall survival at 1-year (68% vs 55%) and 2-year follow-ups (58% vs 24%).
In addition, significantly fewer CF-LVAD patients needed surgery to repair or replace the pump (10% vs 36%; P < .001).
The rate of disabling stroke was similar for both groups (11% for CF-LVAD and 12% for PF-LVAD).
"The results of this trial are such that the [CF-LVAD] should alter the manner in which we provide mechanical circulatory support," summarised Dr. Rogers. "In fact, we believe that in the future there will be little need for pulsatile blood pumps."
Funding for this study was provided by the Thoratec Corporation.
[Presentation title: Outcomes of Patients With Advanced Heart Failure Treated With Either a Pulsatile or Continuous Flow Left Ventricular Assist Device: Results of the HeartMate II Destination Therapy Trial. Abstract LBCT-20018]
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