Registry Study Summarizes Initial US Experience with First Approved TAVR Device

Since the first device for transcatheter aortic valve replacement (TAVR) was approved by the US Food and Drug Administration (FDA) in November 2011, TAVR procedures with the technology have shown safety and efficacy results similar to those of clinical trials, according to national registry data released at the American Heart Association Scientific Sessions and simultaneously published November 17, 2013, in the Journal of the American Medical Association.

Researchers led by Michael J. Mack, MD, of the Baylor Health Care System (Plano, Texas), described findings from the Society of Thoracic Surgeons (STS)/American College of Cardiology (ACC) Transcatheter Valve Therapy (TVT) Registry, reporting results from 224 participating hospitals following commercialization of the Edwards Sapien transcatheter heart valve (Irvine, CA), from November 2011 to May 2013.

Of the 7,710 patients who underwent TAVR with the Sapien device, 20% were inoperable and 80% were high-risk but operable. Median age was 84 years and almost half (49%) were women, with an overall median STS predicted mortality risk of 7%.

High Device Success, Low Complications

Most patients received a transfemoral procedure (64%), followed by transapical (29%), and other alternative approaches (7%). Median hospital stay was 6 days, with 63% discharged home. Successful device implantation occurred in 92% of patients, with an in-hospital mortality rate of 5.5%. Other major complications included stroke (2.0%), dialysis-dependent renal failure (1.9%), and major vascular injury (6.4%). At 30 days, mortality was 7.6%, while stroke was 2.8%. New dialysis occurred in 2.5% and reintervention was necessary in 0.5%.

The authors note 2 key findings from the report, which represents the first public dissemination of data from the US national STS/ACC TVT Registry: “First, postapproval 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 the procedures even with this early-generation approved device are similar to the global experience of TAVR, which now is based on second- and third-generation improved devices.”

In an interview with TCTMD, Philippe Généreux, MD, of Columbia University Medical Center (New York, NY), called the data “reassuring and very favorable for TAVR,” especially with an early-generation, large-sheath device.

“I’m shocked by 6% vascular complications,” he said, “which is very good. These data should prompt approval of the smaller, newer-generation [Edwards] XT device.”

Dr. Généreux noted that the high safety and efficacy of the early US TAVR experience are tributes to the experience of the PARTNER trialists being transmitted to US operators across the country.

Nevertheless, “I was shocked that the median STS score was 7,” Dr. Généreux said. “In PARTNER, the median was 11 in both cohorts B and A. Are we already in the intermediate risk category, with quite good outcomes?”

The fact that 80% of the cohort was high risk with STS scores in the lower range of high risk may have driven the positive outcomes, he added, “but it was using an old, big device; so we may expect better outcomes with a smaller device and in lower risk populations,” Dr. Généreux said.

Source:
Mack MJ, Brennan MJ, Brindis R, et al. Outcomes following transcatheter aortic valve replacement in the United States. JAMA. 2013;310:2069-2077.

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