Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Randomized Controlled Trial
. 2023 Feb 1;8(2):111-119.
doi: 10.1001/jamacardio.2022.4627.

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

Daniel O'Hair  1 , Steven J Yakubov  2 , Kendra J Grubb  3 , Jae K Oh  4 , Saki Ito  4 , G Michael Deeb  5   6 , Nicolas M Van Mieghem  7 , David H Adams  8 , Tanvir Bajwa  9 , Neal S Kleiman  10   11 , Stanley Chetcuti  5   6 , Lars Søndergaard  12 , Hemal Gada  13   14 , Mubashir Mumtaz  13   14 , John Heiser  15   16 , William M Merhi  15   16 , George Petrossian  17 , Newell Robinson  17 , Gilbert H L Tang  8 , Joshua D Rovin  18 , Stephen H Little  10   11 , Renuka Jain  19 , Sarah Verdoliva  20 , Tim Hanson  20 , Shuzhen Li  20 , Jeffrey J Popma  20 , Michael J Reardon  10   11
Affiliations
Randomized Controlled Trial

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

Daniel O'Hair et al. 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.

PubMed Disclaimer

Conflict of interest statement

Conflict of Interest Disclosures: Dr O’Hair has received personal fees from Edwards Lifesciences and Medtronic during the conduct of the study. Dr Yakubov has received grants from Medtronic during the conduct of the study; grants from Boston Scientific; and personal fees from Medtronic and Boston Scientific outside the submitted work. Dr Grubb has received personal fees from Medtronic, Edwards Lifesciences, and Boston Scientific outside the submitted work. Dr Oh has received grants from Medtronic Echo Core during the conduct of the study and personal fees from Medtronic Consulting outside the submitted work. Dr Deeb has received grants from Medtronic during the conduct of the study and personal fees from Medtronic outside the submitted work. Dr Van Mieghem has received grants from Medtronic during the conduct of the study as well as grants from Abbott Vascular, Boston Scientific, Biotronik, Edwards Lifesciences, Medtronic, Abiomed, PulseCath BV, Pie Medical, Daiichi Sankyo, and Materialise outside the submitted work. Dr Adams has received research funding from Medtronic during the conduct of the study and serves as co–principal investigator for trials funded by NeoChord, ReChord, and Abbott outside the submitted work; and has a patent for Edwards Lifesciences with royalties paid and a patent for Medtronic with royalties paid. Dr Bajwa has received personal fees from Medtronic outside the submitted work. Dr Kleiman has received grants from Medtronic, Abbott, Edwards Lifesciences, and Boston Scientific during the conduct of the study. Dr Chetcuti has received grants from Edwards Lifesciences, WL Gore Medical, Medtronic, and Boston Scientific as well as personal fees from Medtronic, Boston Scientific, and Jena during the conduct of the study. Dr Gada has received personal fees from Medtronic, Abbott Vascular, Becton Dickenson, and Boston Scientific outside the submitted work. Dr Mumtaz has received research support from the Japanese Organization for Medical Device Development, Medtronic, ZMedical, Edwards Lifesciences, Teleflex, Atricure, and Abbott as well as personal fees from Medtronic and Edwards Lifesciences during the conduct of the study. Dr Tang has received personal fees from Medtronic, Abbott Structural Heart, and WL Gore Medical outside the submitted work. Dr Rovin has received personal fees from Medtronic and Abbott Vascular during the conduct of the study. Dr Little has received grants from Abbott and Medtronic during the conduct of the study.Dr Jain has received nonfinancial support from Medtronic during the conduct of the study. Dr Reardon has received personal fees from Abbott, Boston Scientific, WL Gore Medical, and Medtronic outside the submitted work. No other disclosures were reported.

Figures

Figure 1.
Figure 1.. Hemodynamics in Patients Randomized to Surgery or Transcatheter Aortic Valve Implantation (TAVI)
Effective orifice area (EOA) and mean gradient hemodynamic trends through 5 years. Patients in the TAVI group had significantly larger EOA and significantly lower mean gradient than patients in the surgery group at all time points after the procedure. RCT indicates randomized clinical trial. aChange from Core Laboratory to site-reported echocardiographic readings.
Figure 2.
Figure 2.. Comparison of Structural Valve Deterioration (SVD) in Patients Randomized to Surgery or Transcatheter Aortic Valve Implantation (TAVI)
Small aortic annuli was defined as computer tomography perimeter-derived diameter of 23 mm or smaller and large aortic annuli as greater than 23 mm. Severe SVD cases were based on status at any follow-up echocardiography, not just at last-available echocardiography. For hazard ratios (HRs), Fine-Gray P values are reported. AR indicates aortic regurgitation; AS, aortic stenosis; RCT, randomized clinical trial.
Figure 3.
Figure 3.. Association Between Clinical Outcomes and Structural Valve Deterioration (SVD)
AV indicates aortic valve; HF, heart failure; HR, hazard ratio; RCT, randomized clinical trial; TAVI, transcatheter aortic valve implantation. aThe all TAVI cohort comprises the pooled RCT and non-RCT populations. bComposite of all-cause mortality or hospitalization for AV disease or worsening HF.
Figure 4.
Figure 4.. Multivariate Predictors of Structural Valve Deterioration (SVD)
HR indicates hazard ratio; RCT, randomized clinical trial; TAVI, transcatheter aortic valve implantation. aThe all TAVI cohort comprises the pooled RCT and non-RCT populations. bHR per 0.2-m2 increase in body surface area.
See this image and copyright information in PMC

Similar articles

See all similar articles

Cited by

See all "Cited by" articles

References

    1. Leon MB, Smith CR, Mack M, et al. ; PARTNER Trial Investigators . Transcatheter aortic-valve implantation for aortic stenosis in patients who cannot undergo surgery. N Engl J Med. 2010;363(17):1597-1607. doi:10.1056/NEJMoa1008232 - DOI - PubMed
    1. Popma JJ, Adams DH, Reardon MJ, et al. ; CoreValve United States Clinical Investigators . Transcatheter aortic valve replacement using a self-expanding bioprosthesis in patients with severe aortic stenosis at extreme risk for surgery. J Am Coll Cardiol. 2014;63(19):1972-1981. doi:10.1016/j.jacc.2014.02.556 - DOI - PubMed
    1. Smith CR, Leon MB, Mack MJ, et al. ; PARTNER Trial Investigators . Transcatheter versus surgical aortic-valve replacement in high-risk patients. N Engl J Med. 2011;364(23):2187-2198. doi:10.1056/NEJMoa1103510 - DOI - PubMed
    1. Adams DH, Popma JJ, Reardon MJ, et al. ; U.S. CoreValve Clinical Investigators . Transcatheter aortic-valve replacement with a self-expanding prosthesis. N Engl J Med. 2014;370(19):1790-1798. doi:10.1056/NEJMoa1400590 - DOI - PubMed
    1. Leon MB, Smith CR, Mack MJ, et al. ; PARTNER 2 Investigators . Transcatheter or surgical aortic-valve replacement in intermediate-risk patients. N Engl J Med. 2016;374(17):1609-1620. doi:10.1056/NEJMoa1514616 - DOI - PubMed

Publication types

Associated data