Balloon-expandable TAVR safe in bicuspid aortic valves
NEW ORLEANS — Patients with bicuspid aortic valves who underwent transcatheter aortic valve replacement with a balloon-expandable valve had similar rates of death and stroke at 1 year, compared with patients with tricuspid aortic valves, according to new data highlighted at the American College of Cardiology Scientific Session.
At 30 days, there were no differences in mortality. However, the bicuspid group had a higher rate of stroke than the tricuspid group.
“Based on this study, patients with bicuspid aortic valve stenosis who are at intermediate or high risk for open-heart surgery can be safely treated by balloon-expandable TAVR with an acceptable risk,” Raj Makkar, MD, associate director of Cedars-Sinai Heart Institute and a member of the Cardiology Today’s Intervention Editorial Board, who presented the data at the American College of Cardiology Scientific Session, said in a press release. “Our study supports the notion that carefully selected patients with bicuspid aortic stenosis can avoid surgery and be treated with this less invasive option.”
Makkar said during a presentation that as many as 50% of younger patients who require surgical AVR have bicuspid valves, and more of these patients will undergo TAVR as its use expands into lower-risk populations, but patients with bicuspid valves have been excluded from pivotal trials of TAVR devices.
Makkar and colleagues analyzed 2,726 patients with bicuspid valves (mean age, 73 years; 60% men) and 79,096 patients with tricuspid valves (mean age, 81 years; 55% men) who were at intermediate or high risk for surgery and underwent TAVR with the balloon-expandable valve (Sapien 3, Edwards Lifesciences) from June 2015 to November 2018 and were listed in the Society of Thoracic Surgeons/ACC Transcatheter Valve Therapy registry.
After propensity matching based on 25 covariates, the researchers compared 2,691 patients with bicuspid valves and 2,691 with tricuspid valves. In the matched cohort, both groups averaged 73 years of age, the bicuspid group had 60% men vs. 61% for the tricuspid group, and differences in baseline STS Predicted Risk of Mortality, carotid stenosis, atrial fibrillation, prior CABG and kidney function were no longer evident.
The primary endpoints were death and stroke at 30 days and 1 year.
The bicuspid group had more conversion to open surgery and annulus rupture, but other procedural outcomes did not differ, Makkar said.
Death and stroke outcomes
At 30 days, all-cause mortality was 2.6% in the bicuspid group and 2.5% in the tricuspid group (P = .82), while stroke occurred in 2.4% of the bicuspid group and 1.6% of the tricuspid group (P = .02), according to the researchers.
New pacemakers were more common in the bicuspid group at 30 days (P = .03), but there were no differences in life-threatening bleeding, major vascular complications or aortic valve reinterventions, Makkar said.
At 1 year in the matched cohort, there was no difference in mortality (HR = 0.9; 95% CI, 0.73-1.1), stroke (HR = 1.28; 95% CI, 0.91-1.79) or the combination of the two (HR = 0.97; 95% CI, 0.81-1.16), he said, noting most strokes occurred within the first 3 days and the bicuspid group had a higher rate of periprocedural stroke.
There was no significant difference in paravalvular leak at discharge (P = .08), 30 days (P = .17) or 1 year (P = .44), nor were there differences in hemodynamic parameters at any point, according to the researchers.
Both groups showed similar improvement in NYHA HF class and Kansas City Cardiomyopathy Questionnaire overall summary score, Makkar said.
“The results indicate that survival, stroke and valve function were very acceptable and similar to tricuspid aortic stenosis, which is the more common type of aortic stenosis,” Makkar said in the release. “Using a CT scan prior to the procedure to predict which bicuspid valves should be triaged to surgery rather than TAVR is a crucial area of research.” – by Erik Swain, with additional reporting by Katie Kalvaitis
Makkar R, et al. Joint American College of Cardiology/New England Journal of Medicine Late-Breaking Clinical Trials. Presented at: American College of Cardiology Scientific Session; March 16-18, 2019; New Orleans.
Disclosures: The statistical analyses were performed by Edwards Lifesciences and are not endorsed by the STS or ACC. Makkar reports he receives consultant fees/honoraria and research/grant support from Abbott, Boston Scientific, Edwards Lifesciences and Medtronic, and holds equity in Entourage Medical.