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Structural Valve Deterioration After Self-Expanding Transcatheter or Surgical Aortic Valve Implantation in Patients at Intermediate or High Risk
- Source :
- O'Hair , D , Yakubov , S J , Grubb , K J , Oh , J K , Ito , S , Deeb , G M , Van Mieghem , N M , Adams , D H , Bajwa , T , Kleiman , N S , Chetcuti , S , Søndergaard , L , Gada , H , Mumtaz , M , Heiser , J , Merhi , W M , Petrossian , G , Robinson , N , Tang , G H L , Rovin , J D , Little , S H , Jain , R , Verdoliva , S , Hanson , T , Li , S , Popma , J J & Reardon , M J 2023 , ' Structural Valve Deterioration After Self-Expanding Transcatheter or Surgical Aortic Valve Implantation in Patients at Intermediate or High Risk ' , JAMA Cardiology , vol. 8 , no. 2 , pp. 111-119 .
- Publication Year :
- 2023
-
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%; sur
Details
- Database :
- OAIster
- Journal :
- O'Hair , D , Yakubov , S J , Grubb , K J , Oh , J K , Ito , S , Deeb , G M , Van Mieghem , N M , Adams , D H , Bajwa , T , Kleiman , N S , Chetcuti , S , Søndergaard , L , Gada , H , Mumtaz , M , Heiser , J , Merhi , W M , Petrossian , G , Robinson , N , Tang , G H L , Rovin , J D , Little , S H , Jain , R , Verdoliva , S , Hanson , T , Li , S , Popma , J J & Reardon , M J 2023 , ' Structural Valve Deterioration After Self-Expanding Transcatheter or Surgical Aortic Valve Implantation in Patients at Intermediate or High Risk ' , JAMA Cardiology , vol. 8 , no. 2 , pp. 111-119 .
- Notes :
- application/pdf, English
- Publication Type :
- Electronic Resource
- Accession number :
- edsoai.on1414369047
- Document Type :
- Electronic Resource