Valve-in-valve transcatheter aortic valve replacement (VIV-TAVR) is associated with strong 30-day and one-year outcomes, even among low-risk patients, according to a new analysis published in Circulation: Cardiovascular Interventions.
“The approved indication for VIV-TAVR has been limited to high-risk patients,” wrote lead author Tsuyoshi Kaneko, MD, of the division of cardiac surgery at Brigham and Women’s Hospital in Boston, and colleagues. “The expansion into lower-risk is halted mainly due to the lack of extensive clinical data in low- and intermediate-risk patients undergoing VIV-TAVR. With the complexity of repeat surgical aortic valve replacement coupled with its high operative mortality and morbidity, there is a growing interest in the expansion of VIV-TAVR to lower-risk profile patients.”
The study’s authors tracked data from more than 145,000 patients who underwent TAVR with the Sapien 3 device. All patients were treated in the United States from June 2015 to January 2020, and 3% of the cohort underwent VIV-TAVR.
Patients in the VIV-TAVR group had an average age of 73.9. years old, 66.4% were male and the mean Society of Thoracic Surgeons (STS) score was 6.9. The most common valve sizes were 23 mm (50.6% of patients) and 26 mm (27.5%). The median follow-up time was 3.9 years.
Overall, device success for VIV-TAVR patients was 91.3%. The stroke rate was 1.4%, and the major vascular complication rate was 09%. New pacemaker implantation was required for 2.1% of patients.
While 30-day all-cause mortality was 2.4%, one-year all-cause mortality was 10.8%. Moderate to severe aortic regurgitation was seen in 0.9% of patients after 30 days and 1.3% after one year.
“In this real-world study, VIV-TAVR had excellent 30-day and 1-year outcomes, especially in lower-risk patients,” the authors wrote. “This study provides evidence for the safety and feasibility of VIV-TAVR in lower-STS score patients and supports the expansion of current indication to the lower-risk patients, although long-term follow-up of these valves continues to be crucial.”
Read the full study here.
Michael has more than 16 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.