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Propensity-Matched Outcomes After TAVR in Low-Risk Bicuspid and Tricuspid Patients
Quick Takes
- This propensity-matched comparison between two prospective TAVR trials compared 1-year clinical and hemodynamic outcomes in low-surgical-risk patients with bicuspid or tricuspid severe aortic stenosis (AS).
- The Evolut supra-annular valve was highly effective at resolving severe symptomatic AS in low-risk patients with both bicuspid and tricuspid aortic valves, with no significant differences between the propensity-matched groups in any procedural, clinical, or forward flow hemodynamic outcomes at 30 days or 1 year.
Study Questions:
What is the 1-year outcome following transcatheter aortic valve replacement (TAVR) in low-surgical-risk patients with bicuspid versus tricuspid aortic stenosis (AS)?
Methods:
The Low Risk Bicuspid Study was a multicenter, prospective, single-arm TAVR study, which enrolled patients from 25 US sites in 2018-2019. The same sites also participated in the multicenter, prospective Evolut Low Risk trial, which randomized low-risk patients with tricuspid valve AS to TAVR versus surgery.
The same national screening committee reviewed patients for eligibility for both trials. Eligible patients had either severe symptomatic AS or met American College of Cardiology/American Heart Association Class IIa criteria for asymptomatic AVR. Computed tomography was used to confirm valve sizing by annular measurements and native aortic valve type using the Sievers classification. All echocardiographic data were assessed by one independent core laboratory. Patients in the Low Risk Bicuspid Study were propensity-matched 1:1 to the tricuspid AS patients in the TAVR arm of the Evolut Low Risk trial. Matching was based on age (≤70 vs. >70 years), sex, body surface area (≤1.9 m2 vs. >1.9 m2), Society of Thoracic Surgeons (STS) score (≤1.3% vs. >13%), diabetes mellitus, cerebrovascular disease, atrial fibrillation/flutter, prior myocardial infarction, and aortic annular perimeter.
The primary outcome was a composite of death, disabling stroke, or aortic valve-related hospitalization. Secondary outcomes included repeat hospitalization for aortic valve disease, major bleeding, pacemaker implantation, prosthetic valve endocarditis, valve thrombosis, and valve-related dysfunction requiring repeat procedure at 1 year. Forward flow hemodynamics were also reported, including mean gradient, effective orifice area, and degree of paravalvular leak (PVL).
Results:
A total of 150 patients underwent attempted TAVR in the Low Risk Bicuspid Study and 700 patients underwent TAVR in the Evolut Low Risk trial. Propensity-matching resulted in 145 matched pairs. Median follow-up was 388 (371-431) days in the bicuspid group and 733 (533-748) days in the tricuspid group (p < 0.001). All-cause mortality or disabling stroke at 1 year was 1.4% in the bicuspid group and 2.8% in the propensity-matched tricuspid valve group (p = 0.413). A permanent pacemaker was implanted in 16.6% of bicuspid and 17.9% of tricuspid patients (p = 0.741). Forward flow hemodynamics were similar at 1 year, including effective orifice area (2.2 ± 0.7 vs. 2.3 ± 0.6 cm2, p = 0.677) and mean gradient (8.7 ± 3.9 vs. 8.5 ± 3.1 mm Hg, p = 0.754) for the bicuspid and tricuspid groups, respectively. Patients in the bicuspid group had significantly less mild or worse PVL at 1 year (21.3 vs. 42.6%, p < 0.001) compared to the tricuspid group.
Conclusions:
The Evolut supra-annular valve was highly effective at resolving severe symptomatic AS in low-risk patients with both bicuspid and tricuspid aortic valves, with no significant differences between the propensity-matched groups in any procedural, clinical, or forward flow hemodynamic outcomes at 30 days or 1 year.
Perspective:
Bicuspid aortic valves have been perceived as challenging for TAVR due to morphologic variants in valve structure, annular and left ventricular outflow tract shape, and different calcium deposition patterns resulting in possible malposition of the device and complications such as aortic tear, root rupture, and coronary artery occlusion. This propensity-matched comparison between two prospective TAVR trials compared 1-year clinical and hemodynamic outcomes in low-surgical-risk patients with bicuspid or tricuspid severe AS. No significant differences in procedural, clinical, or forward flow hemodynamics were seen between the two groups, and somewhat surprisingly, the bicuspid group had significantly less mild or worse PVL at 1 year compared to the tricuspid group. While the Evolut Low Risk trial showed noninferiority of TAVR compared to surgery, there is no ability to extrapolate these data to how TAVR would compare to surgical AVR in bicuspid aortic patients. A randomized trial with long-term outcomes would be essential to answer this question.
Clinical Topics: Arrhythmias and Clinical EP, Cardiac Surgery, Cardiovascular Care Team, Congenital Heart Disease and Pediatric Cardiology, Geriatric Cardiology, Heart Failure and Cardiomyopathies, Invasive Cardiovascular Angiography and Intervention, Noninvasive Imaging, Valvular Heart Disease, Atrial Fibrillation/Supraventricular Arrhythmias, 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, CHD and Pediatrics and Prevention, Acute Heart Failure, Interventions and Imaging, Interventions and Structural Heart Disease, Interventions and Vascular Medicine, Echocardiography/Ultrasound
Keywords: Aortic Valve Stenosis, Cardiac Surgical Procedures, Atrial Fibrillation, Atrial Flutter, Bicuspid Aortic Valve Disease, Cerebrovascular Disorders, Diabetes Mellitus, Echocardiography, Endocarditis, Bacterial, Geriatrics, Heart Failure, Heart Valve Diseases, Heart Valve Prosthesis, Hemodynamics, Hemorrhage, Myocardial Infarction, Pacemaker, Artificial, Stroke, Thrombosis, Tomography, Transcatheter Aortic Valve Replacement, Tricuspid Valve Stenosis
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