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Alternative access shows promise in extreme-risk patients treated with CoreValve
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TORONTO — New data demonstrate positive outcomes for extreme-risk patients with severe aortic stenosis who were treated with the CoreValve System via alternative access routes.
Most transcatheter aortic valve replacement procedures are performed using the transfemoral approach, but a nonfemoral approach is sometimes necessary, particularly in patients with unsuitable iliac anatomy to permit that approach, Michael J. Reardon, MD, professor of cardiothoracic surgery at Methodist DeBakey and Vascular Center in Houston, said at the American Association for Thoracic Surgery Annual Meeting.
Michael J. Reardon
The study included 150 patients from the CoreValve US Pivotal Trial (23% of the extreme-risk patient group) who were not suitable for traditional TAVR via the transfemoral route and, therefore, treated with the CoreValve (Medtronic) via subclavian (n=70) or direct aortic (n=80) approaches.
“These are patients who are likely to die if they are not treated,” Reardon told Cardiology Today. He said medical therapy has proven largely ineffective in this patient population, and the risk for mortality is 50% within 1 year.
The extreme-risk patients assigned to alternative access routes had higher rates of peripheral vascular disease (61.3% vs. 35.2%; P=.001), severe chronic lung disease (39.3% vs. 23.5%; P<.001) and home oxygen therapy (44% vs. 29.9%; P=.002) compared with patients assigned TAVR via the transfemoral route.
“These patients also tended to be smaller,” Reardon said in an interview. Nearly 15% of the alternative access group had BMI less than 21 kg/m2 compared with 8.6% of the transfemoral group (P=.04).
The primary outcome was all-cause mortality or stroke at 12 months. In the alternative access group, this rate was 15.3% at 30 days and 39.4% at 12 months vs. 26% at 12 months among patients treated via the transfemoral approach. Individual rates of all-cause mortality were 11.3% at 30 days and 36% at 12 months, and individual rates of major stroke were 7.5% at 30 days and 9.1% at 12 months.
Among the patients with paravalvular regurgitation at discharge, 85.7% improved within 1 year, and the rate was 2.4% at 12 months, Reardon said.
Upon completion of the Extreme Risk Study, an additional 339 patients were treated via a subclavian or direct aortic approach in the Continued Access Study. The 30-day mortality rate in the pivotal alternative access patients was 11.3%, and in the Continued Access Study, this rate improved to 9.5%. Also, in the Continued Access Study, rates of major stroke at 30 days (3% vs. 7.5%; P=.03) and major vascular complications (4.2% vs. 8.7%; P=.04) were significantly reduced vs. the pivotal trial, according to a press release.
“These data show that we can use alternative access approaches to treat these patients,” Reardon said. – by Louise Gagnon
For more information:
Reardon MJ. LB4: Late-breaking clinical trial. Self-expanding transcatheter aortic valve replacement using alternative access sites in patients with severe aortic stenosis deemed extreme risk for surgery. Presented at: American Association for Thoracic Surgery Annual Meeting; April 26-30, 2014; Toronto.
Disclosure: Reardon reports receiving consultant fees/honoraria from Medtronic.