Basel Ramlawi, MD, is a cardiothoracic surgeon at Valley Health System in Virginia and the study’s co-principal investigator. He can be contacted at Basel.Ramlawi@gmail.com.
The Low Risk Bicuspid Study, presented at the American College of Cardiology together with World Congress of Cardiology Scientific Sessions (ACC.20/WCC) meeting, is the first to prospectively examine TAVR’s safety for treating severe aortic stenosis in relatively young, healthy patients — in whom open-heart surgery would pose a low risk — who have a bicuspid valve.
Researchers prospectively tracked 150 patients who underwent TAVR at 25 medical centers in the U.S. On average, patients were 70 years old and had a Society of Thoracic Surgeons risk score of 1.4%. Thirty days after their procedure, just 1.3% of patients had died or experienced a disabling stroke, the study’s primary safety endpoint. Patients also had an overall device success rate of 95.3%, reflecting 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.
Bicuspid valves can have several different shapes, which are named according to the Sievers classification system. The study found 84.6% of those with a Sievers type 0 valve had trace or no aortic regurgitation and the rest had only mild aortic regurgitation, a high rate of success.
The researchers plan to continue to track outcomes in the patients for 10 years to assess the long-term efficacy of the TAVR-implanted valves.
The trial was funded by Medtronic, maker of the self-expanding Evolut valves used in the study.