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Randomized Controlled Trial
. 2022 Oct 1;7(10):1000-1008.
doi: 10.1001/jamacardio.2022.2695.

Self-expanding Transcatheter vs Surgical Aortic Valve Replacement in Intermediate-Risk Patients: 5-Year Outcomes of the SURTAVI Randomized Clinical Trial

Nicolas M Van Mieghem  1 , G Michael Deeb  2   3 , Lars Søndergaard  4   4 , Eberhard Grube  5 , Stephan Windecker  6 , Hemal Gada  7   8 , Mubashir Mumtaz  7   8 , Peter S Olsen  4   4 , John C Heiser  9   10 , William Merhi  9   10 , Neal S Kleiman  11   12 , Stanley J Chetcuti  2 , Thomas G Gleason  13   14   15 , Joon Sup Lee  13   15 , Wen Cheng  16   17 , Raj R Makkar  16   17 , Juan Crestanello  18   19   20 , Barry George  18   20 , Isaac George  21   22 , Susheel Kodali  21   22 , Steven J Yakubov  23 , Patrick W Serruys  1   24 , Rüdiger Lange  25 , Nicolo Piazza  26 , Mathew R Williams  27 , Jae K Oh  28 , David H Adams  29 , Shuzhen Li  30 , Michael J Reardon  11   12 ; SURTAVI Trial Investigators
Collaborators, Affiliations
Randomized Controlled Trial

Self-expanding Transcatheter vs Surgical Aortic Valve Replacement in Intermediate-Risk Patients: 5-Year Outcomes of the SURTAVI Randomized Clinical Trial

Nicolas M Van Mieghem et al. JAMA Cardiol. .

Abstract

Importance: In patients with severe aortic valve stenosis at intermediate surgical risk, transcatheter aortic valve replacement (TAVR) with a self-expanding supra-annular valve was noninferior to surgery for all-cause mortality or disabling stroke at 2 years. Comparisons of longer-term clinical and hemodynamic outcomes in these patients are limited.

Objective: To report prespecified secondary 5-year outcomes from the Symptomatic Aortic Stenosis in Intermediate Risk Subjects Who Need Aortic Valve Replacement (SURTAVI) randomized clinical trial.

Design, setting, and participants: SURTAVI is a prospective randomized, unblinded clinical trial. Randomization was stratified by investigational site and need for revascularization determined by the local heart teams. Patients with severe aortic valve stenosis deemed to be at intermediate risk of 30-day surgical mortality were enrolled at 87 centers from June 19, 2012, to June 30, 2016, in Europe and North America. Analysis took place between August and October 2021.

Intervention: Patients were randomized to TAVR with a self-expanding, supra-annular transcatheter or a surgical bioprosthesis.

Main outcomes and measures: The prespecified secondary end points of death or disabling stroke and other adverse events and hemodynamic findings at 5 years. An independent clinical event committee adjudicated all serious adverse events and an independent echocardiographic core laboratory evaluated all echocardiograms at 5 years.

Results: A total of 1660 individuals underwent an attempted TAVR (n = 864) or surgical (n = 796) procedure. The mean (SD) age was 79.8 (6.2) years, 724 (43.6%) were female, and the mean (SD) Society of Thoracic Surgery Predicted Risk of Mortality score was 4.5% (1.6%). At 5 years, the rates of death or disabling stroke were similar (TAVR, 31.3% vs surgery, 30.8%; hazard ratio, 1.02 [95% CI, 0.85-1.22]; P = .85). Transprosthetic gradients remained lower (mean [SD], 8.6 [5.5] mm Hg vs 11.2 [6.0] mm Hg; P < .001) and aortic valve areas were higher (mean [SD], 2.2 [0.7] cm2 vs 1.8 [0.6] cm2; P < .001) with TAVR vs surgery. More patients had moderate/severe paravalvular leak with TAVR than surgery (11 [3.0%] vs 2 [0.7%]; risk difference, 2.37% [95% CI, 0.17%- 4.85%]; P = .05). New pacemaker implantation rates were higher for TAVR than surgery at 5 years (289 [39.1%] vs 94 [15.1%]; hazard ratio, 3.30 [95% CI, 2.61-4.17]; log-rank P < .001), as were valve reintervention rates (27 [3.5%] vs 11 [1.9%]; hazard ratio, 2.21 [95% CI, 1.10-4.45]; log-rank P = .02), although between 2 and 5 years only 6 patients who underwent TAVR and 7 who underwent surgery required a reintervention.

Conclusions and relevance: Among intermediate-risk patients with symptomatic severe aortic stenosis, major clinical outcomes at 5 years were similar for TAVR and surgery. TAVR was associated with superior hemodynamic valve performance but also with more paravalvular leak and valve reinterventions.

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Conflict of interest statement

Conflict of Interest Disclosures: Dr Van Mieghem reported grants from Medtronic during the conduct of the study and grants from Abbott Vascular, Edwards Lifesciences, Boston Scientific, Abiomed, PulseCath BV, and Daiichi Sankyo outside the submitted work. Dr Deeb reported grants from Medtronic (paid to their institution) during the conduct of the study and personal fees from Medtronic outside the submitted work. Dr Grube reported personal fees for serving as a proctor and a member of the strategic advisory board for Medtronic during the conduct of the trial and has equity in Sentinel (now Boston Scientific) outside the submitted work. Dr Windecker reported grants from Abbott, Abiomed, Amgen, AstraZeneca, Bayer, Biotronik, Boehringer Ingelheim, Boston Scientific, Bristol Meyers Squibb, Cardinal Health, CardioValve, Corflow Therapeutics, CSL Behring, Daiichi Sankyo, Edwards Lifesciences, Guerbet, InfraRedx, Janssen-Cilag, Johnson & Johnson, Medicure, Medtronic, Merck, Miracor Medical, Novartis, Novo Nordisk, Organon, OrPha Suisse, Pfizer, Polares, Regeneron, Sanofi-Aventis, Servier, Sinomed, Terumo, Vifor, and V-Wave, all paid to the institution, outside the submitted work; serving as unpaid advisory board member and/or unpaid member of the steering/executive group of trials funded by Abbott, Abiomed, Amgen, Astra Zeneca, Bayer, Boston Scientific, Biotronik, Bristol Myers Squibb, Cardiovalve, Edwards Lifesciences, Janssen, MedAlliance, Medtronic, Novartis, Polares, Recardio, Sinomed, Terumo, V-Wave, and Xeltis but has not received personal payments by pharmaceutical companies or device manufacturers; serving as an unpaid member of the Pfizer Research Award selection committee in Switzerland and of the Women as One Awards Committee; serving as a member of the Clinical Study Group of the Deutsches Zentrum für Herz Kreislauf-Forschung and of the advisory board of the Australian Victorian Heart Institute; and serving as chairperson of the European Society of Cardiology Congress Program Committee and Deputy Editor of Journals of the American College of Cardiology Cardiovascular Interventions. Dr Gada reported personal fees from Medtronic, Abbott Vascular, Boston Scientific, and Becton Dickenson outside the submitted work. Dr Mumtaz reported grants and personal fees from Medtronic, Edwards Lifesciences, Atricure, Japanese Organization for Medical Device Development, and ZMedical outside the submitted work. Dr Kleiman reports clinical trial reimbursement to his institution (Houston Methodist DeBakey Heart and Vascular Center) during the conduct of the study. Dr Chetcuti reported personal fees from Medtronic; grants from Edwards, Boston Scientific, and Jena (paid to their institution) during the conduct of the study; and serves on advisory boards for Biotrace and Jena valve without remuneration. Dr Gleason reported institutional research support from Medtronic during the conduct of the study and serves on a medical advisory board for Abbott without remuneration. Dr Lee reported grants from University of Pittsburgh Medical Center during the conduct of the study. Dr Makkar reported grants from Abbott and Edwards Lifesciences and personal fees from Cordis, Medtronic, and Cedars-Sinai Medical Center during the conduct of the study and outside the submitted work. Dr Crestanello serves on a surgical advisory board for Medtronic outside of the submitted work. Dr I. George reported grants from Medtronic paid to their institution during the conduct of the study. Dr Kodali reported grants from Medtronic (paid to their institution) during the conduct of the study; grants from Edwards Lifesciences, Boston Scientific, Abbott Vascular, and JenaValve (paid to their institution); personal fees from Admedus, Phillips, TriFlo, and Tricares; serving on the science advisory board of Dura Biotech and Thubrikar Aortic Valve; equity from Supira, Adona, Tioga, X-Dot, Dura Biotech, and Thubrikar Aortic Valve outside the submitted work. Dr Yakubov reported grants from Boston Scientific and Medtronic (paid to their institution) and personal fees from Medtronic during the conduct of the study. Dr Serruys reported personal fees from SMT, Novartis, Merillife, Xeltis, Sino Medical, and Philips/Volcano outside the submitted work. Dr Lange reports receiving consulting fees and royalties from Medtronic, consulting fees and equity from Highlife, and consulting fees from Abbott outside of the submitted work. Dr Piazza reported consulting fees from Peijia and Medtronic outside the submitted work. Dr Williams reported personal fees from Medtronic during the conduct of the study and consulting fees from Medtronic outside the submitted work. Dr Oh served as the head of the echocardiographic core laboratory for the trial. Dr Adams reported grants from Medtronic during the conduct of the trial; served as the national co-principal investigator for NeoChord and the Medtronic APOLLO trial outside the submitted work; and receives patent royalties paid to the Icahn School of Medicine at Mount Sinai - Edwards Lifesciences and Medtronic for intellectual property related to development of valve repair rings. Dr Li reported personal fees from Medtronic during the conduct of the study and outside the submitted work. Dr Reardon reported grants from Medtronic (paid to their institution) during the conduct of the study and consulting fees from Boston Scientific, Abbott, and Gore Medical (paid to their institution) outside the submitted work. No other disclosures were reported.

Figures

Figure 1.
Figure 1.. Kaplan-Meier Time to Event Analyses
Cox proportional hazard ratio (HR) and 95% CIs are reported. TAVR indicates transcatheter aortic valve replacement.
Figure 2.
Figure 2.. Hemodynamics
Patients in the transcatheter aortic valve replacement (TAVR) group had significantly larger effective orifice area and significantly lower mean gradient than the patients in the surgery group at all time points (all P < .001). ECHO indicates echocardiogram; MG/EAO, mean aortic valve gradient/effective orifice area.
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References

    1. Vahanian A, Beyersdorf F, Praz F, et al. ; ESC/EACTS Scientific Document Group . 2021 ESC/EACTS Guidelines for the management of valvular heart disease. Eur Heart J. 2022;43(7):561-632. doi:10.1093/eurheartj/ehab395 - DOI - PubMed
    1. Writing Committee Members, Otto CM, Nishimura RA, Bonow RO, et al. . 2020 ACC/AHA guideline for the management of patients with valvular heart disease: executive summary: a report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. J Am Coll Cardiol. 2021;77(4):450-500. doi:10.1016/j.jacc.2020.11.035 - DOI - PubMed
    1. Gleason TG, Reardon MJ, Popma JJ, et al. . 5-Year outcomes of self-expanding transcatheter versus surgical aortic valve replacement in high-risk patients. J Am Coll Cardiol. 2018;72(22):2687-2696. doi:10.1016/j.jacc.2018.08.2146 - DOI - PubMed
    1. Mack MJ, Leon MB, Smith CR, et al. . 5-Year outcomes of transcatheter aortic valve replacement or surgical aortic valve replacement for high surgical risk patients with aortic stenosis (PARTNER 1): a randomised controlled trial. Lancet. 2015;385(9986):2477-2484. doi:10.1016/S0140-6736(15)60308-7 - DOI - PubMed
    1. Mack MJ, Leon MB, Thourani VH, et al. ; PARTNER 3 Investigators . Transcatheter aortic-valve replacement with a balloon-expandable valve in low-risk patients. N Engl J Med. 2019;380(18):1695-1705. doi:10.1056/NEJMoa1814052 - DOI - PubMed

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