Low-risk patients with severe aortic stenosis (AS) undergoing surgical aortic valve replacement (SAVR) saw better or similar outcomes as predicted by surgical risk scores, except in patients undergoing concomitant mitral or tricuspid valve (CMTV) interventions, according to a real-world analysis released Monday.
Randomized controlled trials comparing low-risk patients undergoing transcatheter aortic valve replacement (TAVR) and SAVR were the first to thoroughly detail outcomes in SAVR. However, these trials excluded many subsets of patients (non-tricuspid aortic valve [NTAV], severe coronary artery disease [SevCAD], CMTV disease and concomitant ascending aorta disease [CAAR]).
Albert Alperi, MD, of the Quebec Heart & Lung Institute, Laval University, Quebec City, Quebec, Canada, and co-investigators, reported their findings in a manuscript published in the Jan. 19 issue of the Journal of the American College of Cardiology.
They sought to describe a real-world experience of SAVR in low-risk patients including patients with NTAV, SevCAD, CMTV and/or CAAR. Included were patients with Society of Thoracic Surgeons (STS) scores <4%, indicating low surgical risk. They then examined baseline clinical characteristics, procedural characteristics and outcomes, and 30-day outcomes prospectively.
Between 2000 and 2019, 6,772 patients who underwent SAVR were screened, of whom 5,310 were deemed to be at low risk based on their STS risk score. Patients had a mean STS risk score of 1.94%. Among patients included, 40.8% had at least one of the following: NTAV (1,468, 27.6%), SevCAD (307, 5.8%), CMTV (306, 5.8%), or CAAR (560, 10.5%).
At 30 days, all-cause mortality was 1.9% and stroke occurred in 2.4% of patients. Mortality was similar to the STS predicted risk of mortality in patients who underwent SAVR and had concomitant SevCAD or CAAR. Mortality was lower in the NTAVR group (0.9%; odds ratio [OR], 0.42; 95% confidence interval [CI], 0.22, 0.81) and higher in the CMTV group (5.9%; OR: 2.6; 95% CI, 1.51, 4.5).
Poonam Velagapudi, MD, of the University of Nebraska Medical Center, Omaha, and colleagues wrote an accompanying editorial to the study. In it they, applauded the authors and discussed the importance of clinical variables when considering treatment options in low-risk patients with severe AS during heart team meetings. They highlighted that there are certain criteria that must be present before considering TAVR in this low-risk group, including concomitant valvular heart disease, SevCAD, favorable transfemoral access and valve anatomy.
They then homed in on patients with bicuspid AS. This subgroup of patients presents unique challenges when considering TAVR. Eccentric and bulky leaflet calcium could lead to asymmetric valve deployment, paravalvular leak and coronary obstruction. Furthermore, suboptimal valve deployment in bicuspid patients could adversely affect bioprostheses durability, the editorialists wrote.
They concluded that given the lack of randomized data in these patient subgroups, a detailed and extensive heart team discussion much take place when considering TAVR in these patients.
Alperi A, Voisine P, Kalavrouziotis D, et al. Aortic Valve Replacement in Low-Risk Patients With Severe Aortic Stenosis Outside Randomized Trials. J Am Coll Cardiol 2021;77:111–23.
Velagapudi P, Bapat V, Kodali S. When Excluded From Randomized Clinical Trials: To “OR” or “TAVR”? J Am Coll Cardiol 2021;77:124–7.