Transcatheter Versus Surgical Aortic Valve Replacement in Low-Risk Patients: Puzzle Solved?

HomeJournal of the American Heart AssociationVol. 12, No. 21Transcatheter Versus Surgical Aortic Valve Replacement in Low‐Risk Patients: Puzzle Solved? Open AccessEditorialPDF/EPUBAboutView PDFView EPUBSections ToolsAdd to favoritesDownload citationsTrack citationsPermissions ShareShare onFacebookTwitterLinked InMendeleyReddit Jump toOpen AccessEditorialPDF/EPUBTranscatheter Versus Surgical Aortic Valve Replacement in Low‐Risk Patients: Puzzle Solved? Hafiz Imran and Marwan Saad Hafiz ImranHafiz Imran https://orcid.org/0000-0003-1436-9629 , Lifespan Cardiovascular Institute, , Providence, , RI, , USA, , Department of Medicine, Division of Cardiology, , Warren Alpert Medical School of Brown University, , Providence, , RI, , USA, Search for more papers by this author and Marwan SaadMarwan Saad *Correspondence to: Marwan Saad, MD, PhD, Lifespan Cardiovascular Institute, Rhode Island Hospital, 593 Eddy St, APC 745, Providence, RI 02903. Email: E-mail Address: [email protected] https://orcid.org/0000-0002-2280-8030 , Lifespan Cardiovascular Institute, , Providence, , RI, , USA, , Department of Medicine, Division of Cardiology, , Warren Alpert Medical School of Brown University, , Providence, , RI, , USA, Search for more papers by this author Originally published6 Nov 2023https://doi.org/10.1161/JAHA.123.030953Journal of the American Heart Association. 2023;12:e030953This article is a commentary on the followingMidterm Survival of Low‐Risk Patients Treated With Transcatheter Versus Surgical Aortic Valve Replacement: Meta‐Analysis of Reconstructed Time‐to‐Event DataOther version(s) of this articleYou are viewing the most recent version of this article. Previous versions: November 6, 2023: Ahead of Print The approval of transcatheter aortic valve replacement (TAVR) by the US Food and Drug Administration for patients with severe aortic stenosis at low risk for surgical aortic valve replacement (SAVR) after the PARTNER 3 and Evolut Low Risk trials1, 2 has led to a paradigm shift in the treatment of aortic stenosis worldwide. In the United States, low‐risk patients made up nearly 12% of all patients undergoing TAVR in 2019.3 A more recent report showed that TAVR was performed in 87.5% of patients between 65 and 80 years of age and 47.5% of those <65 years of age who required aortic valve replacement for isolated severe aortic stenosis in 2021.4 With this quick uptake of TAVR, longer‐term outcomes in low‐risk patients have been eagerly awaited.In this issue of the Journal of the American Heart Association (JAHA), Sá and colleagues performed a meta‐analysis of 3 randomized controlled trials and 5 propensity score‐matched studies, involving a total of 5444 patients and comparing midterm outcomes with TAVR versus SAVR in patients deemed at low surgical risk.5 Low perioperative procedural risk of mortality was determined by the Society of Thoracic Surgeons (STS) Risk Model in 6 studies, and the European System for Cardiac Operative Risk Evaluation (EuroSCORE II) in 2 studies. All‐cause mortality, the main and only outcome examined, was similar with either approach at 2 years of follow‐up (hazard ratio [HR], 1.08 [95% CI, 0.89–1.31], P=0.448), but in favor of SAVR beyond 2 years in a landmark analysis (HR, 1.51 [95% CI, 1.14–2.00], P=0.004). Interestingly, improved midterm survival with SAVR was observed only in propensity‐score matched studies but not in randomized controlled trials.To our knowledge, the current study is the largest pooled analysis to date and is a commendable effort to address a complex question. The complexity of this question stems from multiple aspects. One aspect is the definition of “low risk.” While STS score and EuroSCORE II are widely used and effective, they come with limitations. These scores include chronological age and many relevant clinical comorbidities, but unfortunately, critical variables such as frailty, cognitive impairment, mobility, and social support are not well represented in either score. Frailty was shown in several studies to strongly predict worse outcomes after cardiac surgery6 and TAVR.7, 8 At times, physicians may rely on these factors in their risk stratification and choice of aortic valve replacement strategy among patients within the same surgical‐risk category. Hence, performing risk stratification for patients based solely on these scores in propensity‐matched studies precludes the role of physician judgment and clinical expertise, and is likely to underestimate the perioperative risk. In the study by Schaefer et al, one of the propensity score‐matched studies included in the current meta‐analysis, the authors attributed the inferior midterm survival with TAVR versus SAVR at 5 years to the sicker population undergoing TAVR despite a well‐performed propensity score matching.9 That was also observed in the study from the Aortic Valve Replacement in Elective Patients From the Aortic Valve Multicenter (AVALON) Registry,10 where despite a comprehensive propensity‐score matching, patients in the TAVR group had higher EuroSCORE II and poor mobility, defined by the authors as severe impairment of mobility secondary to musculoskeletal or neurological dysfunction. These markers of frailty are key factors in determining not only the early postoperative surgical risk but also long‐term outcomes. In addition, the predictability of mortality can vary with STS score versus EuroSCORE II in different patient populations,11 and thus examining outcomes in a pooled analysis of studies using different risk scores is suboptimal and should be interpreted with caution.Another aspect of complexity is making sure we examine outcomes in an adequate sample size that rejects the play of chance. In the current study, the authors performed robust time‐to‐event analysis, however, unfortunately only 2 studies, 1 randomized controlled trial,12 and 1 propensity score‐matched study,10 provided follow‐up beyond 5 years, with a significant drop in the number of patients in both arms at 6 years (TAVR n=85, SAVR n=83) (Figure).9, 10, 12, 13, 14, 15, 16, 17Download figureDownload PowerPointFigure . Studies included in the meta‐analysis with the corresponding follow‐up (years).AVALON indicates the aortic valve replacement in elective patients from the aortic valve multicenter registry; EVOLUT Low‐Risk, medtronic evolut transcatheter aortic valve replacement in low risk patients; FinnValve, the nationwide finnish registry of transcatheter and surgical aortic valve replacement for aortic valve stenosis; NOTION, nordic aortic valve intervention; OBSERVANT, observational study of effectiveness of SAVR–TAVI procedures for severe aortic stenosis treatment; PARTNER, placement of aortic transcatheter valve trial; PSM, propensity score‐matched study; and RCT, randomized controlled trial.Finally, given that mid‐ and long‐term all‐cause mortality after TAVR or SAVR can either be secondary to a cardiovascular or noncardiovascular cause, data about clinical events (eg, heart failure hospitalization, stroke, myocardial infarction) and structural valve function (eg, transvalvular gradient, paravalvular leak, need for reoperation) are critical elements in performing a fair head‐to‐head comparison of both therapies. In the current study, Sá and colleagues took the analysis a step further and performed comprehensive meta‐regression analyses of difference covariates, including valve function such as prosthesis‐patient mismatch and paravalvular leak, and did not find a modulating impact on outcomes. This reassuring finding goes in line with the results of the Nordic Aortic Valve Intervention trial that showed similarly low rates of bioprosthetic valve failure with TAVR versus SAVR at 8 years follow‐up (8.7% versus 10.5%, respectively; P=0.61).The meta‐analysis by Sá et al5 reports interesting results that add to the ongoing debate, but the complex question is far from being answered. Given the limitations of analysis and variability in outcomes among randomized controlled trials and propensity score‐matched studies, the authors correctly cautioned against definitive conclusions, emphasizing the importance of a heart team approach while we wait for the longer‐term outcomes of randomized controlled trials comparing TAVR versus SAVR in low‐risk patients with severe aortic stenosis.DisclosuresDr Saad is a consultant for Boston Scientific. Dr Imran has no disclosures to report.Footnotes*Correspondence to: Marwan Saad, MD, PhD, Lifespan Cardiovascular Institute, Rhode Island Hospital, 593 Eddy St, APC 745, Providence, RI 02903. Email: marwan_saad@brown.eduSee article by Sá et al.This manuscript was sent to Amgad Mentias, MD, Associate Editor, for editorial decision and final disposition.For Disclosures, see page 3.References1 Mack MJ, Leon MB, Thourani VH, Makkar R, Kodali SK, Russo M, Kapadia SR, Malaisrie SC, Cohen DJ, Pibarot P, et al. Transcatheter aortic‐valve replacement with a balloon‐expandable valve in low‐risk patients. N Engl J Med. 2019; 380:1695–1705. doi: 10.1056/NEJMoa1814052CrossrefMedlineGoogle Scholar2 Popma JJ, Deeb GM, Yakubov SJ, Mumtaz M, Gada H, O'Hair D, Bajwa T, Heiser JC, Merhi W, Kleiman NS, et al. Transcatheter aortic‐valve replacement with a self‐expanding valve in low‐risk patients. N Engl J Med. 2019; 380:1706–1715. doi: 10.1056/NEJMoa1816885CrossrefMedlineGoogle Scholar3 Carroll JD, Mack MJ, Vemulapalli S, Herrmann HC, Gleason TG, Hanzel G, Deeb GM, Thourani VH, Cohen DJ, Desai N, et al. STS‐ACC TVT registry of transcatheter aortic valve replacement. J Am Coll Cardiol. 2020; 76:2492–2516. doi: 10.1016/j.jacc.2020.09.595CrossrefMedlineGoogle Scholar4 Sharma T, Krishnan AM, Lahoud R, Polomsky M, Dauerman HL. National trends in TAVR and SAVR for patients with severe isolated aortic stenosis. J Am Coll Cardiol. 2022; 80:2054–2056. doi: 10.1016/j.jacc.2022.08.787CrossrefMedlineGoogle Scholar5 Sá MP, Jacquemyn X, Van den Eynde J, Serna‐Gallegos D, Chu D, Clavel M‐A, Pibarot P, Sultan I. Midterm survival of low‐risk patients treated with transcatheter vs surgical aortic valve replacement: meta‐analysis of reconstructed time‐to‐event data. J Am Heart Assoc. 2023; 12:e030012. doi: 10.1161/JAHA.123.030012LinkGoogle Scholar6 Sepehri A, Beggs T, Hassan A, Rigatto C, Shaw‐Daigle C, Tangri N, Arora RC. The impact of frailty on outcomes after cardiac surgery: a systematic review. J Thorac Cardiovasc Surg. 2014; 148:3110–3117. doi: 10.1016/j.jtcvs.2014.07.087CrossrefMedlineGoogle Scholar7 Green P, Arnold SV, Cohen DJ, Kirtane AJ, Kodali SK, Brown DL, Rihal CS, Xu K, Lei Y, Hawkey MC, et al. Relation of frailty to outcomes after transcatheter aortic valve replacement (from the PARTNER trial). Am J Cardiol. 2015; 116:264–269. doi: 10.1016/j.amjcard.2015.03.061CrossrefMedlineGoogle Scholar8 Strange JE, Christensen DM, Sindet‐Pedersen C, Schou M, Falkentoft AC, Østergaard L, Butt JH, Graversen PL, Køber L, Gislason G, et al. Frailty and recurrent hospitalization after transcatheter aortic valve replacement. J Am Heart Assoc. 2023; 12:e029264. doi: 10.1161/JAHA.122.029264LinkGoogle Scholar9 Schaefer A, Schofer N, Goßling A, Seiffert M, Schirmer J, Deuschl F, Schneeberger Y, Voigtländer L, Detter C, Schaefer U, et al. Transcatheter aortic valve implantation versus surgical aortic valve replacement in low‐risk patients: a propensity score‐matched analysis. Eur J Cardiothorac Surg. 2019; 56:1131–1139. doi: 10.1093/ejcts/ezz245CrossrefMedlineGoogle Scholar10 Kowalówka AR, Kowalewski M, Wańha W, Kołodziejczak M, Mariani S, Li T, Pasierski M, Łoś A, Stefaniak S, Malinowski M, et al. Surgical and transcatheter aortic valve replacement for severe aortic stenosis in low‐risk elective patients: analysis of the Aortic Valve Replacement in Elective Patients From the Aortic Valve Multicenter Registry. J Thorac Cardiovasc Surg. 2022:S0022‐5223(22)01148‐5. doi: 10.1016/j.jtcvs.2022.10.026CrossrefGoogle Scholar11 Bouabdallaoui N, Stevens SR, Doenst T, Petrie MC, Al‐Attar N, Ali IS, Ambrosy AP, Barton AK, Cartier R, Cherniavsky A, et al. Society of Thoracic Surgeons risk score and EuroSCORE‐2 appropriately assess 30‐day postoperative mortality in the STICH trial and a contemporary cohort of patients with left ventricular dysfunction undergoing surgical revascularization. Circ Heart Fail. 2018; 11:e005531. doi: 10.1161/CIRCHEARTFAILURE.118.005531LinkGoogle Scholar12 Jørgensen TH, Thyregod HGH, Ihlemann N, Nissen H, Petursson P, Kjeldsen BJ, Steinbrüchel DA, Olsen PS, Søndergaard L. Eight‐year outcomes for patients with aortic valve stenosis at low surgical risk randomized to transcatheter vs. surgical aortic valve replacement. Eur Heart J. 2021; 42:2912–2919. doi: 10.1093/eurheartj/ehab375CrossrefMedlineGoogle Scholar13 Rosato S, Santini F, Barbanti M, Biancari F, D'Errigo P, Onorati F, Tamburino C, Ranucci M, Covello RD, Santoro G, et al. Transcatheter aortic valve implantation compared with surgical aortic valve replacement in low‐risk patients. Circ Cardiovasc Interv. 2016; 9:e003326. doi: 10.1161/CIRCINTERVENTIONS.115.003326LinkGoogle Scholar14 Virtanen MPO, Eskola M, Jalava MP, Husso A, Laakso T, Niemelä M, Ahvenvaara T, Tauriainen T, Maaranen P, Kinnunen E‐M, et al. Comparison of outcomes after transcatheter aortic valve replacement vs surgical aortic valve replacement among patients with aortic stenosis at low operative risk. JAMA Netw Open. 2019; 2:e195742. doi: 10.1001/jamanetworkopen.2019.5742CrossrefMedlineGoogle Scholar15 Vilalta V, Alperi A, Cediel G, Mohammadi S, Fernández‐Nofrerias E, Kalvrouziotis D, Delarochellière R, Paradis J‐M, González‐Lopera M, Fadeuilhe E, et al. Midterm outcomes following sutureless and transcatheter aortic valve replacement in low‐risk patients with aortic stenosis. Circ Cardiovasc Interv. 2021; 14:e011120. doi: 10.1161/CIRCINTERVENTIONS.121.011120LinkGoogle Scholar16 Leon MB, Mack MJ, Hahn RT, Thourani VH, Makkar R, Kodali SK, Alu MC, Madhavan MV, Chau KH, Russo M, et al. Outcomes 2 years after transcatheter aortic valve replacement in patients at low surgical risk. J Am Coll Cardiol. 2021; 77:1149–1161. doi: 10.1016/j.jacc.2020.12.052CrossrefMedlineGoogle Scholar17 Forrest JK, Deeb GM, Yakubov SJ, Rovin JD, Mumtaz M, Gada H, O'Hair D, Bajwa T, Sorajja P, Heiser JC, et al. 2‐year outcomes after transcatheter versus surgical aortic valve replacement in low‐risk patients. J Am Coll Cardiol. 2022; 79:882–896. doi: 10.1016/j.jacc.2021.11.062CrossrefMedlineGoogle Scholar eLetters(0) eLetters should relate to an article recently published in the journal and are not a forum for providing unpublished data. Comments are reviewed for appropriate use of tone and language. Comments are not peer-reviewed. Acceptable comments are posted to the journal website only. Comments are not published in an issue and are not indexed in PubMed. Comments should be no longer than 500 words and will only be posted online. References are limited to 10. Authors of the article cited in the comment will be invited to reply, as appropriate. Comments and feedback on AHA/ASA Scientific Statements and Guidelines should be directed to the AHA/ASA Manuscript Oversight Committee via its Correspondence page. Sign In to Submit a Response to This Article Previous Back to top Next FiguresReferencesRelatedDetailsRelated articlesMidterm Survival of Low‐Risk Patients Treated With Transcatheter Versus Surgical Aortic Valve Replacement: Meta‐Analysis of Reconstructed Time‐to‐Event DataMichel Pompeu Sá, et al. Journal of the American Heart Association. 2023;12 November 7, 2023Vol 12, Issue 21 Article Information Metrics Copyright © 2023 The Authors. Published on behalf of the American Heart Association, Inc., by Wiley BlackwellThis is an open access article under the terms of the Creative Commons Attribution‐NonCommercial‐NoDerivs License, which permits use and distribution in any medium, provided the original work is properly cited, the use is non‐commercial and no modifications or adaptations are made.https://doi.org/10.1161/JAHA.123.030953PMID: 37929671 Originally publishedNovember 6, 2023 KeywordsEditorialslow riskSAVRTAVRPDF download Subjects Cardiovascular Surgery