In patients with symptomatic severe aortic stenosis undergoing aortic valve replacement, valve performance was superior at 5 years in patients undergoing transcatheter aortic valve implantation (TAVI) compared to surgery, according to a pooled analysis of two large trials.
Steven J. Yakubov, MD, of OhioHealth/Riverside Methodist Hospital, Columbus, reported these findings during a Late-Breaking Trial presentation Monday at Cardiovascular Research Technologies (CRT) 2023 in Washington, D.C.
In younger, low-risk patients with longer life expectancy, the long-term performance of bioprosthetic valves after transcatheter aortic valve implantation (TAVI) is a critical consideration.
Academic statements recognize four components of valve performance that are evaluated as bioprosthetic valve dysfunction: structural valve deterioration (SVD), non-structural valve dysfunction (NSVD), valve thrombosis and endocarditis.
A recent analysis with supra-annular, self-expanding TAVI bioprostheses showed a significantly lower 5-year rate of SVD with TAVI as compared with surgery. This study also reported an association between SVD and worse clinical outcomes.
However, limited data exist concerning the incidence and clinical importance of all components of valve performance after TAVI and surgery.
The objective of the current study was to evaluate the incidence, outcomes and predictors of
Long-term valve performance, as assessed by 5-year BVD, in patients undergoing TAVI with supra-annular, self-expanding bioprosthetic valves or surgery. This analysis pooled data from the CoreValve U.S. High-Risk pivotal and SURTAVI Intermediate-Risk randomized clinical trials (n=2,099)
At baseline, the TAVI (n=1,128) and surgery (n=971) cohorts had similar characteristics: they were majority male (54% to 56%), mean age of about 81 years, with a mean Society of Thoracic Surgeons Predicted Risk of Mortality Score of about 5.2%, about two-thirds with New York Heart Association heart failure class III or IV.
At 5 years post-procedure, TAVI showed a significantly lower rate of BVD than surgery (7.8% vs. 14.2%; hazard ratio [HR]: 0.50, 95% confidence interval [CI]: 0.38-0.66; p<0.001 by Fine-Gray regression interval censoring and treating death as a competing risk).
Moreover, the pooled TAVI group showed a two times lower rate of SVD at 5 years (2.2% vs. 4.4%; HR: 0.46, 95% CI: 0.27-0.78; p=0.04) and a three times lower rate of severe patient-prosthesis mismatch (PPM; 3.7% vs. 11.8%; odds ratio: 0.29, 95% CI: 0.19-0.43) compared to surgery.
TAVI also conferred a significantly lower rate of BVD than surgery at 5 years in smaller annuli, defined as a diameter of 23 mm or less (8.6% vs. 19.7%; HR: 0.31, 95% CI: 0.18-0.55; p<0.001 by Fine-Gray regression interval censoring and treating death as a competing risk). A similar pattern was seen in larger valves.
BVD imparted a 1.5 times greater risk for all-cause mortality, cardiovascular mortality, and hospitalization for valve disease or worsening heart failure at 5 years.
Study limitations include that the follow-up was limited to 5 years, but the SURTAVI trial has ongoing 10-year follow-up. Also, the competing risk of mortality and inclusion of only randomized patients limited the number of subjects with BVD.
Yakubov said long-term valve performance should be a key consideration in the selection of the first bioprosthesis, particularly in younger, low-risk patients. The CoreValve/Evolut supra-annular, self-expanding bioprosthesis is the only transcatheter valve to demonstrate superior valve performance at 5 years compared with surgery in randomized clinical trials, he added.
Image Credit: Jason Wermers/CRTonline.org