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Post-approval data on LVAD consistent with pivotal trial
Starling R. J Am Coll Cardiol. 2011;57:1890-1898.
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New data from the INTERMACS registry have shown similarly favorable results with the HeartMate II left ventricular assist device as were found in the multicenter pivotal trial that led to the approval of the device for bridge to transplantation.
The researchers performed the prospective evaluation on the first 169 consecutive patients with a HeartMate II (HM II, Thoratec Corp.) LVAD enrolled in the national Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) from April to August 2008. All patients were listed for transplant or likely to be listed, and they were compared with a comparison group of equal size that included other types of Thoratec LVADs (79% HeartMate XVE; 21% Implantable Ventricular Assist Device).
During a follow-up of at least 1 year, less adverse events occurred in the HM II group, including rates of the most frequent adverse event bleeding (1.44 vs. 1.79 events/patient-year), as well as operative 30-day mortality (4% vs. 11%) and in-hospital mortality (6% vs. 15%; P=.012).
Compared with the comparison group, the rate of patients who received HM II and reached transplant, cardiac recovery or ongoing LVAD support at 6 months was notably higher (91% vs. 80%), as was the survival of patients remaining on support at 1 year (85% vs. 70%).
“These data suggest that dissemination of this technology has been associated with excellent results and further incremental improvement of outcomes,” the researchers wrote. “Importantly, this is the first example of the utility of the INTERMACS registry to conduct a post-market approval study with an LVAD and to demonstrate prospective outcomes with standardized definitions.”
A retrospective on the first 5 years of the INTERMACS registry, written by James Young, MD, of the Cleveland Clinic Foundation, can be viewed here.
Disclosure: Several researchers involved in the trial reported financial relationships with Thoratec.
The post-marketing report on the HM II is very encouraging for a life-saving product demonstrated to successfully bridge patients to heart transplantation or recovery. Compared to the pivotal trial in 2007, outcomes for the HM II have improved over time including 30-day mortality,1-year survival, as well as transplantation, recovery or ongoing device support at 180 days. Adverse events were comparable or less for the HM II compared to other ventricular assist devices. Overall, the advanced heart disease community has demonstrated safe and effective use of the HM II in the post-marketing era. This study also underscores the importance of the INTERMACS registry to document prospective outcomes with standardized definitions.
Jon Kobashigawa, MD
Cardiology Today
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