HeartMate II performs well in "real world"

Reed Miller

May 04, 2011

Cleveland, OH - Patients implanted with a HeartMate II (Thoratec) left ventricular assist device (LVAD) following its 2008 FDA approval have had similar outcomes to what was predicted by the clinical-trial results [1].

A comparison of the outcomes of the HeartMate II with similar patients treated with other LVADs shows that "dissemination of this technology after approval has been associated with continued excellent results," according to study authors Dr Randall Starling (Cleveland Clinic, OH) and colleagues. "Surprisingly, as the HeartMate II device became available outside of the controlled context of a clinical trial, excellent results were maintained or perhaps surpassed."

One-year follow-up data from the first 169 consecutive HeartMate II bridge-to-transplant patients and 169 patients treated with another LVAD as a bridge to transplant were published in the May 10, 2011 issue of the Journal of the American College of Cardiology. All of the patients were either listed for transplant or considered likely to be listed and were enrolled in the Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS), a mandatory registry of LVAD patients that collects survival, adverse-event, and quality-of-life data.

The baseline characteristics of the HeartMate II and comparison groups were similar except that the creatinine and blood urea nitrogen levels were slightly lower in the HeartMate II groups, and there were fewer patients in the highest-risk INTERMACS patient profile 1 (acute cardiogenic shock)—about 24% of the HeartMate II patients vs about 39% of the comparison group, suggesting "there is clearly a shift in earlier use of devices in less ill patients," Starling et al write.

The Kaplan-Meier survival analysis for patients remaining on support at one year was 85% for the HeartMate II vs 70% for the comparison group. Operative 30-day mortality for the HeartMate II patients was 4% vs 11% for the comparison group. The percentage of patients reaching transplant, cardiac recovery, or ongoing LVAD support by six months was 91% for the HeartMate II group and 80% for the comparison group, and quality of life was significantly improved at three months of support and sustained through one year in both groups.

The adverse-event rates in the HeartMate II group were similar to or lower than those of the comparison group for all types of adverse events. Bleeding was the most frequent adverse event for both groups—1.44 events per patient-year in the HeartMate II patients vs 1.79 events per patient-year in the comparison patients. The stroke rates were 6.5% in the HeartMate II patients and 5.3% in the comparison group (p=0.3821).

The FDA approved HeartMate II as a bridge to transplant primarily based on the results of 133 HeartMate II patients implanted at 26 US centers in 2005 and 2006. Overall actuarial survival for patients continuing to receive pump support was 89% at one month, 75% at six months, and 68% at 12 months. Almost a third of those patients developed bleeding that required surgery over the six-month follow-up, and 8% had a stroke.

This study was supported by Thoratec . Starling has received support from Thoratec . Disclosures for the coauthors are listed in the paper.

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