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TAVR With SAPIEN 3 in Bicuspid Low-Surgical-Risk Patients
Quick Takes
- This study evaluated balloon-expandable TAVR in bicuspid aortic valve (BAV) aortic stenosis (AS) at low surgical risk, and reported that death, stroke, rehospitalization, and new pacemaker implantation were similar to those in a propensity-matched cohort of patients with tricuspid aortic valve AS.
- These findings, while reassuring, should not be extended to potentially elevated TAVR risk BAV anatomies, given that severe raphe calcification was a notable exclusion from the study.
- Finally, only 1-year outcomes in the combined bicuspid group are reported and longer-term prospective assessment of structural valve deterioration in bicuspid patients undergoing TAVR is needed.
Study Questions:
What are the 1-year safety and efficacy outcomes of transcatheter aortic valve replacement (TAVR) with SAPIEN 3 (S3) in low-surgical-risk patients with severe bicuspid aortic valve (BAV) morphology stenosis and those with tricuspid aortic valve (TAV) morphology and severe stenosis?
Methods:
The investigators pooled and propensity-score matched low-risk, severe aortic stenosis (AS) patients with BAV in the PARTNER 3 (Placement of Aortic Transcatheter Valves 3) (P3) bicuspid registry or the P3 bicuspid continued access protocol to TAV morphology patients from the P3 randomized TAVR trial. Outcomes were compared between groups. The primary endpoint was the 1-year composite rate of death, stroke, and cardiovascular rehospitalization. Analyses of clinical outcomes, New York Heart Association class, and Kansas City Cardiomyopathy Questionnaire Overall Summary score were performed on both the propensity-score matched and unmatched populations. Results for the composite primary endpoint and its individual components (all-cause mortality, all stroke, and cardiovascular rehospitalization) at 30 days and 1 year were presented as Kaplan-Meier (KM) rates.
Results:
Of 320 total submitted BAV patients, 169 (53%) were treated, and most were Sievers type 1. The remaining 151 patients were excluded due to anatomic or clinical criteria. Propensity-score matching with the P3 TAVR cohort (496 patients) yielded 148 pairs. There were no differences in baseline clinical characteristics; however, BAV patients had larger annuli, and they experienced longer procedure duration. There was no difference in the primary endpoint between BAV and TAV (10.9% vs. 10.2%; p = 0.80), or in the rates of the individual components (death: 0.7% vs. 1.4%; p = 0.58; stroke: 2.1% vs. 2.0%; p = 0.99; cardiovascular rehospitalization: 9.6% vs. 9.5%; p = 0.96).
Conclusions:
The authors concluded that among highly selected bicuspid AS low-surgical-risk patients without extensive raphe or subannular calcification, TAVR with the S3 valve demonstrated similar outcomes to a matched cohort of patients with tricuspid AS.
Perspective:
This study evaluated contemporary balloon-expandable TAVR in BAV AS at low surgical risk, and reported that death, stroke, rehospitalization, and new pacemaker implantation were similar to those in a propensity-matched cohort of patients with TAV AS. In addition, important echocardiographic outcomes such as paravalvular regurgitation and transvalvular gradients were also similar in the populations studied. These findings, while reassuring, should not be extended to potentially elevated TAVR risk BAV anatomies, given that severe raphe calcification was a notable exclusion from the study. Finally, only 1-year outcomes in the combined bicuspid group are reported and longer-term prospective assessment of structural valve deterioration in bicuspid patients is needed.
Clinical Topics: Cardiac Surgery, Congenital Heart Disease and Pediatric Cardiology, Geriatric Cardiology, Heart Failure and Cardiomyopathies, Invasive Cardiovascular Angiography and Intervention, Noninvasive Imaging, Prevention, Valvular Heart Disease, Aortic Surgery, Cardiac Surgery and Arrhythmias, Cardiac Surgery and CHD and Pediatrics, Cardiac Surgery and Heart Failure, Cardiac Surgery and VHD, Congenital Heart Disease, CHD and Pediatrics and Arrhythmias, CHD and Pediatrics and Imaging, CHD and Pediatrics and Interventions, Acute Heart Failure, Interventions and Imaging, Interventions and Structural Heart Disease, Echocardiography/Ultrasound
Keywords: Aortic Valve Stenosis, Bicuspid Aortic Valve Disease, Cardiovascular Surgical Procedures, Coronary Stenosis, Diagnostic Imaging, Echocardiography, Geriatrics, Heart Failure, Heart Valve Diseases, Heart Valve Prosthesis, Pacemaker, Artificial, Secondary Prevention, Stroke, Transcatheter Aortic Valve Replacement, Tricuspid Valve Stenosis
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