The Sapien transcatheter aortic valve implant made by Edwards Lifesciences (NYSE:EW) fared well in an analysis of roughly 7,700 real-world implantations since its U.S. approval in November 2011, according to a study published yesterday in the Journal of the American Medical Assn.
Researchers examined results from a transcatheter valve therapy registry run by the Society of Thoracic Surgeons and the American College of Cardiology that was initiated when Edwards won pre-market approval from the FDA for the device.
Sapien valves were successfully implanted in 91.7% of the cases reviewed, with in-hospital mortality rates of 5.5% and stroke rates of 2.0%, in line with the results from the Partner trial Edwards used to back its PMA application, according to the JAMA study.
"That’s the main theme and message here, that in a real-world experience, there really hasn’t been any significant falloff from what we saw in the randomized controlled trials," Dr. Michael Mack of the Medical City Dallas Hospital told heartwire [free subscription].
Thirty days out, mortality rates were 7.5%, but 52% of those deaths were due to non-cardiovascular causes, according to the study.
"This analysis represents the 1st public report from the U.S. national Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry and documents 2 major findings. First, post-approval commercial introduction of this new technology with an early-generation device has yielded success rates and complication patterns that are similar to those documented in carefully performed randomized trials. Second, the outcomes of procedures even with this early-generation approved device are similar to the global experience of TAVI, which now is based on 2nd- and 3rd-generation improved devices. These findings help address a lingering question of clinical outcomes with the 1st-generation TAVI device after controlled U.S. dissemination to a relatively narrow group of treatment centers," the study’s authors wrote. "Longer-term follow-up is essential to assess continued safety and efficacy as well as patient health status."
Mack called patient selection "the main residual issue." At his hospital, he said, only 1 patient of more than 100 treated in the past year died.
"That’s not because we’re better at doing this than other hospitals, but we are better at selecting patients," he told heartwire. "I think we are getting better at this, and we are a lot better than we were before, but what we still struggle with every day and every week is figuring out who those appropriate patients are."
"This is the first attempt at true post-marketing surveillance in the US," he added. "This represents a new paradigm."
Edwards won its 1st PMA nod from the FDA in November 2011 for the treatment of severe, symptomatic aortic stenosis in patients too sick to undergo open heart surgery. In October 2012 that indication was expanded to include patients "at high risk for serious surgical complications or death" from the open procedure. In September the federal watchdog agency OK’d the expansion of the labeling for Sapien to include delivery via whatever method a physician chooses, rather than specifying insertion through the femoral artery.
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