Structural Valve Deterioration After Self-Expanding Transcatheter or Surgical Aortic Valve Implantation in Patients at Intermediate or High Risk.

Autor:	O'Hair D; Cardiovascular Service Line, Boulder Community Health, Boulder, Colorado., Yakubov SJ; Department of Interventional Cardiology, Ohio Health Riverside Methodist Hospital, Columbus., Grubb KJ; Division of Cardiothoracic Surgery, Emory University School of Medicine, Atlanta, Georgia., Oh JK; Echocardiography Core Laboratory, Mayo Clinic, Rochester, Minnesota., Ito S; Echocardiography Core Laboratory, Mayo Clinic, Rochester, Minnesota., Deeb GM; Department of Interventional Cardiology, University of Michigan Hospitals, Ann Arbor.; Department of Cardiac Surgery, University of Michigan Hospitals, Ann Arbor., Van Mieghem NM; Department of Interventional Cardiology, Erasmus University Medical Center, Rotterdam, the Netherlands., Adams DH; Department of Cardiovascular Surgery, Mount Sinai Health System, New York, New York., Bajwa T; Department of Cardiothoracic Surgery, Aurora St. Luke's Medical Center, Milwaukee, Wisconsin., Kleiman NS; Department of Cardiology, Houston Methodist DeBakey Heart and Vascular Center, Houston, Texas.; Department of Cardiothoracic Surgery, Houston Methodist DeBakey Heart and Vascular Center, Houston, Texas., Chetcuti S; Department of Interventional Cardiology, University of Michigan Hospitals, Ann Arbor.; Department of Cardiac Surgery, University of Michigan Hospitals, Ann Arbor., Søndergaard L; Department of Cardiology, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark., Gada H; Department of Interventional Cardiology, University of Pittsburgh Medical Center Pinnacle Health, Harrisburg, Pennsylvania.; Department of Cardiothoracic Surgery, University of Pittsburgh Medical Center Pinnacle Health, Harrisburg, Pennsylvania., Mumtaz M; Department of Interventional Cardiology, University of Pittsburgh Medical Center Pinnacle Health, Harrisburg, Pennsylvania.; Department of Cardiothoracic Surgery, University of Pittsburgh Medical Center Pinnacle Health, Harrisburg, Pennsylvania., Heiser J; Department of Interventional Cardiology, Spectrum Health, Grand Rapids, Michigan.; Department of Cardiothoracic Surgery, Spectrum Health, Grand Rapids, Michigan., Merhi WM; Department of Interventional Cardiology, Spectrum Health, Grand Rapids, Michigan.; Department of Cardiothoracic Surgery, Spectrum Health, Grand Rapids, Michigan., Petrossian G; Department of Cardiothoracic and Vascular Surgery, Saint Francis Hospital, Roslyn, New York., Robinson N; Department of Cardiothoracic and Vascular Surgery, Saint Francis Hospital, Roslyn, New York., Tang GHL; Department of Cardiovascular Surgery, Mount Sinai Health System, New York, New York., Rovin JD; Center for Advanced Valve and Structural Heart Care, Morton Plant Hospital, Clearwater, Florida., Little SH; Department of Cardiology, Houston Methodist DeBakey Heart and Vascular Center, Houston, Texas.; Department of Cardiothoracic Surgery, Houston Methodist DeBakey Heart and Vascular Center, Houston, Texas., Jain R; Aurora Cardiovascular Services, Aurora-St. Luke's Medical Center, Milwaukee, Wisconsin., Verdoliva S; Structural Heart and Aortic, Medtronic, Minneapolis, Minnesota., Hanson T; Structural Heart and Aortic, Medtronic, Minneapolis, Minnesota., Li S; Structural Heart and Aortic, Medtronic, Minneapolis, Minnesota., Popma JJ; Structural Heart and Aortic, Medtronic, Minneapolis, Minnesota., Reardon MJ; Department of Cardiology, Houston Methodist DeBakey Heart and Vascular Center, Houston, Texas.; Department of Cardiothoracic Surgery, Houston Methodist DeBakey Heart and Vascular Center, Houston, Texas.
Jazyk:	angličtina
Zdroj:	JAMA cardiology [JAMA Cardiol] 2023 Feb 01; Vol. 8 (2), pp. 111-119.
DOI:	10.1001/jamacardio.2022.4627
Abstrakt:	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.
Databáze:	MEDLINE
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