Document Type
Article
Publication Title
JAMA Cardiol
Abstract
IMPORTANCE: The frequency and clinical importance of structural valve deterioration (SVD) in patients undergoing self-expanding transcatheter aortic valve implantation (TAVI) or surgery is poorly understood.
OBJECTIVE: To evaluate the 5-year incidence, clinical outcomes, and predictors of hemodynamic SVD in patients undergoing self-expanding TAVI or surgery.
DESIGN, SETTING, AND PARTICIPANTS: This post hoc analysis pooled data from the CoreValve US High Risk Pivotal (n = 615) and SURTAVI (n = 1484) randomized clinical trials (RCTs); it was supplemented by the CoreValve Extreme Risk Pivotal trial (n = 485) and CoreValve Continued Access Study (n = 2178). Patients with severe aortic valve stenosis deemed to be at intermediate or increased risk of 30-day surgical mortality were included. Data were collected from December 2010 to June 2016, and data were analyzed from December 2021 to October 2022.
INTERVENTIONS: Patients were randomized to self-expanding TAVI or surgery in the RCTs or underwent self-expanding TAVI for clinical indications in the nonrandomized studies.
MAIN OUTCOMES AND MEASURES: The primary end point was the incidence of SVD through 5 years (from the RCTs). Factors associated with SVD and its association with clinical outcomes were evaluated for the pooled RCT and non-RCT population. SVD was defined as (1) an increase in mean gradient of 10 mm Hg or greater from discharge or at 30 days to last echocardiography with a final mean gradient of 20 mm Hg or greater or (2) new-onset moderate or severe intraprosthetic aortic regurgitation or an increase of 1 grade or more.
RESULTS: Of 4762 included patients, 2605 (54.7%) were male, and the mean (SD) age was 82.1 (7.4) years. A total of 2099 RCT patients, including 1128 who received TAVI and 971 who received surgery, and 2663 non-RCT patients who received TAVI were included. The cumulative incidence of SVD treating death as a competing risk was lower in patients undergoing TAVI than surgery (TAVI, 2.20%; surgery, 4.38%; hazard ratio [HR], 0.46; 95% CI, 0.27-0.78; P = .004). This lower risk was most pronounced in patients with smaller annuli (23 mm diameter or smaller; TAVI, 1.32%; surgery, 5.84%; HR, 0.21; 95% CI, 0.06-0.73; P = .02). SVD was associated with increased 5-year all-cause mortality (HR, 2.03; 95% CI, 1.46-2.82; P < .001), cardiovascular mortality (HR, 1.86; 95% CI, 1.20-2.90; P = .006), and valve disease or worsening heart failure hospitalizations (HR, 2.17; 95% CI, 1.23-3.84; P = .008). Predictors of SVD were developed from multivariate analysis.
CONCLUSIONS AND RELEVANCE: This study found a lower rate of SVD in patients undergoing self-expanding TAVI vs surgery at 5 years. Doppler echocardiography was a valuable tool to detect SVD, which was associated with worse clinical outcomes.
TRIAL REGISTRATION: ClinicalTrials.gov Identifiers: NCT01240902, NCT01586910, and NCT01531374.
First Page
111
Last Page
119
DOI
10.1001/jamacardio.2022.4627
Publication Date
2-1-2023
Recommended Citation
O'Hair, Daniel; Yakubov, Steven J; Grubb, Kendra J; Oh, Jae K; Ito, Saki; Deeb, G Michael; Van Mieghem, Nicolas M; Adams, David H; Bajwa, Tanvir; Kleiman, Neal S; Chetcuti, Stanley; Søndergaard, Lars; Gada, Hemal; Mumtaz, Mubashir; Heiser, John; Merhi, William M; Petrossian, George; Robinson, Newell; Tang, Gilbert H L; Rovin, Joshua D; Little, Stephen H; Jain, Renuka; Verdoliva, Sarah; Hanson, Tim; Li, Shuzhen; Popma, Jeffrey J; and Reardon, Michael J, "Structural Valve Deterioration After Self-Expanding Transcatheter or Surgical Aortic Valve Implantation in Patients at Intermediate or High Risk." (2023). Heart and Vascular Articles. 28.
https://scholarlyworks.ohiohealth.com/heart-vascular-articles/28