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March 29, 2020

Safety Data Presented for TAVR in Patients With Bicuspid Valve

March 29, 2020—The American College of Cardiology (ACC) announced that a study showing that transcatheter aortic valve replacement (TAVR) procedures had a high rate of success and low risk of death or disabling stroke at 30 days in patients with a bicuspid aortic valve was presented by Basel Ramlawi, MD, at the virtual conference of the ACC's Annual Scientific Session Together with World Congress of Cardiology (ACC.20/WCC).

In the ACC announcement, Dr. Ramlawi commented, “TAVR with a self-expanding prosthesis is a very viable and safe procedure in low-risk bicuspid patients and achieved excellent early results. Though additional follow-up is necessary to determine long-term outcomes, early results suggest this procedure can be performed successfully in low- risk individuals with a good outcome.”

The study prospectively tracked 150 patients (average age, 70 years; Society of Thoracic Surgeons risk score of 1.4%) who underwent TAVR at 25 medical centers in the United States. The trial was funded by Medtronic, maker of the self-expanding valves used in the study.

As summarized in the ACC press release, the study’s primary safety endpoint of death or disabling stroke at 30 days postprocedure was 1.3%. The overall device success rate of 95.3% reflects a low rate of major complications, ill-fitting valves, or the need for additional procedures. The vast majority (99.3%) of patients survived the procedure, 96% showed correct positioning of the valve and 100% had mild or no aortic regurgitation.

Additionally, the study found that 84.6% of those with a Sievers type 0 valve had trace or no aortic regurgitation and the rest had only mild aortic regurgitation. Dr. Ramlawi noted that this high rate of success was somewhat unexpected because of the perceived complexity of operating on valves with this shape.

In the ACC press release, Dr. Ramlawi commented, “This is the first study that shows the self-expanding valve works well for patients with both type 1 and type 0 bicuspid valves. The medical community has perceived type 0 bicuspid valves as more challenging to treat, so those data are especially encouraging.”

As noted in the announcement, the investigators plan to continue to track outcomes in the patients for 10 years to assess the long-term efficacy of the TAVR-implanted valves.

Dr. Ramlawi advised that the study was limited by the fact that all patients received TAVR, rather than providing a randomized comparison between TAVR and open surgery. In addition, the study was conducted in medical centers that perform a high volume of TAVR procedures, and it is unclear whether a similarly high success rate would be achievable in centers with less TAVR experience.

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