Advertisement
Canadian Journal of Cardiology

Transcatheter vs Surgical Aortic Valve Replacement for Aortic Stenosis in Low-Intermediate Risk Patients: A Meta-analysis

  • Derrick Y. Tam
    Affiliations
    Division of Cardiac Surgery, Department of Surgery, Schulich Heart Centre, Sunnybrook Health Sciences Centre, University of Toronto, Toronto, Ontario, Canada

    Institute of Health Policy, Management and Evaluation, University of Toronto, Toronto, Ontario, Canada
    Search for articles by this author
  • Thin Xuan Vo
    Affiliations
    School of Medicine, Queen's University, Kingston, Ontario, Canada
    Search for articles by this author
  • Harindra C. Wijeysundera
    Affiliations
    Institute of Health Policy, Management and Evaluation, University of Toronto, Toronto, Ontario, Canada

    Division of Cardiology, Department of Medicine, Schulich Heart Centre, Sunnybrook Health Sciences Centre, University of Toronto, Toronto, Ontario, Canada
    Search for articles by this author
  • Dennis T. Ko
    Affiliations
    Institute of Health Policy, Management and Evaluation, University of Toronto, Toronto, Ontario, Canada

    Division of Cardiology, Department of Medicine, Schulich Heart Centre, Sunnybrook Health Sciences Centre, University of Toronto, Toronto, Ontario, Canada
    Search for articles by this author
  • Rodolfo Vigil Rocha
    Affiliations
    Division of Cardiac Surgery, Department of Surgery, Schulich Heart Centre, Sunnybrook Health Sciences Centre, University of Toronto, Toronto, Ontario, Canada
    Search for articles by this author
  • Jan Friedrich
    Affiliations
    Division of Critical Care Medicine, Department of Medicine, St Michael's Hospital, University of Toronto, Toronto, Ontario, Canada
    Search for articles by this author
  • Stephen E. Fremes
    Correspondence
    Corresponding author: Dr Stephen E. Fremes, Division of Cardiac Surgery, Department of Surgery, Schulich Heart Centre, Sunnybrook Health Sciences Centre, 2075 Bayview Ave, Room H4 05, Toronto, Ontario M4N 3M5, Canada. Tel.: +1-416-480-6073; fax: +1-416-480-4439.
    Affiliations
    Division of Cardiac Surgery, Department of Surgery, Schulich Heart Centre, Sunnybrook Health Sciences Centre, University of Toronto, Toronto, Ontario, Canada

    Institute of Health Policy, Management and Evaluation, University of Toronto, Toronto, Ontario, Canada
    Search for articles by this author

      Abstract

      Background

      Transcatheter aortic valve replacement (TAVR) has emerged as the treatment of choice for patients with severe aortic stenosis at high surgical risk; the role of TAVR compared with surgical aortic valve replacement (SAVR) in the low-intermediate surgical risk population remains uncertain. Our primary objective was to determine differences in 30-day and late mortality in patients treated with TAVR compared with SAVR at low-intermediate risk (Society of Thoracic Surgeons Predicted Risk of Mortality < 10%).

      Methods

      Medline and Embase were searched from 2010 to March 2017 for studies that compared TAVR with SAVR in the low-intermediate surgical risk population, restricted to randomized clinical trials and matched observational studies. Two investigators independently abstracted the data and a random effects meta-analysis was performed.

      Results

      Four randomized clinical trials (n = 4042) and 9 propensity score-matched observational studies (n = 4192) were included in the meta-analysis (n = 8234). There was no difference in 30-day mortality between TAVR and SAVR (3.2% vs 3.1%, pooled risk ratio: 1.02; 95% confidence interval, 0.80-1.30; P = 0.89; I2 = 0%) or mortality at a median of 1.5-year follow-up (incident rate ratio: 1.01; 95% confidence interval, 0.90-1.15; P = 0.83; I2 = 0%). There was a higher risk of pacemaker implantation and greater than trace aortic insufficiency in the TAVR group whereas the risk of early stroke, atrial fibrillation, acute kidney injury, cardiogenic shock, and major bleeding was higher in the SAVR group.

      Conclusions

      Although there was no difference in 30-day and late mortality, the rate of complications differed between TAVR and SAVR in the low-intermediate surgical risk population.

      Résumé

      Introduction

      Le remplacement valvulaire aortique par cathéter (RVAC) constitue le traitement de choix pour les patients atteints d’une sténose aortique grave qui sont exposés à un risque opératoire élevé. Le rôle du RVAC par rapport à la chirurgie de remplacement valvulaire aortique (CRVA) dans une population exposée à un risque opératoire faible à intermédiaire demeure incertain. Notre premier objectif était de déterminer les différences de mortalité à 30 jours et de mortalité tardive entre les patients traités par RVAC et les patients traités par la CRVA qui sont exposés à un risque opératoire faible à intermédiaire (la prédiction du risque de mortalité de la Society of Thoracic Surgeons < 10 %).

      Méthodes

      Des recherches ont été effectuées dans Medline et Embase, couvrant la période de 2010 à mars 2017, pour trouver les études qui avait pour objet de comparer le RVAC à la CRVA dans une population exposée à un risque faible à intermédiaire en s’en tenant aux essais cliniques à répartition aléatoire et aux études observationnelles appariées. Deux chercheurs ont extrait de manière indépendante les données pour réaliser une méta-analyse à effets aléatoires.

      Résultats

      Quatre essais cliniques à répartition aléatoire (n = 4042) et 9 études observationnelles appariées par score de propension (n = 4192) ont été inclus dans la méta-analyse (n = 8234). Aucune différence dans la mortalité à 30 jours entre le RVAC et la CRVA (3,2 % vs 3,1 %, risque relatif pondéré : 1,02 ; intervalle de confiance [IC] à 95 %, 0,80-1,30 ; P = 0,89 ; I2 = 0 %) ou la mortalité selon une durée médiane de suivi de 1,5 an (rapport de taux d’incidence : 1,01 ; IC à 95 %, 0,90-1,15 ; P = 0,83 ; I2 = 0 %). Il y avait un risque plus élevé d’implantation de stimulateur cardiaque et plus important qu’une trace d’insuffisance aortique dans le groupe de RVAC alors que le risque précoce d’accident vasculaire cérébral, de fibrillation auriculaire, d’insuffisance rénale aiguë, de choc cardiogénique et d’hémorragie grave était élevé dans le groupe de CRVA.

      Conclusions

      Bien qu’il n’y ait eu aucune différence dans la mortalité à 30 jours et la mortalité tardive, le taux de complications différait entre le RVAC et la CRVA dans la population exposée à un risque opératoire faible à intermédiaire.
      To read this article in full you will need to make a payment

      Purchase one-time access:

      Academic & Personal: 24 hour online accessCorporate R&D Professionals: 24 hour online access
      One-time access price info
      • For academic or personal research use, select 'Academic and Personal'
      • For corporate R&D use, select 'Corporate R&D Professionals'

      Subscribe:

      Subscribe to Canadian Journal of Cardiology
      Already a print subscriber? Claim online access
      Already an online subscriber? Sign in
      Institutional Access: Sign in to ScienceDirect

      References

        • Leon M.B.
        • Smith C.R.
        • Mack M.
        • et al.
        Transcatheter aortic valve implantation for aortic stenosis in patients who cannot undergo surgery.
        N Engl J Med. 2010; 363: 1597-1607
        • Smith C.R.
        • Leon M.B.
        • Mack M.J.
        • et al.
        Transcatheter versus surgical aortic valve replacement in high-risk patients.
        N Engl J Med. 2011; 364: 2187-2198
        • Leon M.B.
        • Smith C.R.
        • Mack M.J.
        • et al.
        Transcatheter or surgical aortic valve replacement in intermediate-risk patients.
        N Engl J Med. 2016; 374: 1609-1620
        • Reardon M.J.
        • Van Mieghem N.M.
        • Popma J.J.
        • et al.
        Surgical or Transcatheter aortic-valve replacement in intermediate risk patients.
        N Engl J Med. 2017; 376: 1321-1331
      1. Morrison A. Transcatheter Aortic Valve Replacement [Environmental Scan, Issue 40]. Ottawa: Canadian Agency for Drugs and Technologies in Health; 2013.

        • Stroup D.F.
        • Berlin J.A.
        • Morton S.C.
        • et al.
        Meta-analysis of observational studies in epidemiology: a proposal for reporting. Meta-analysis Of Observational Studies in Epidemiology (MOOSE) group.
        JAMA. 2000; 283: 2008-2012
        • Kappetein A.P.
        • Head S.J.
        • Généreux P.
        • et al.
        Updated standardized endpoint definitions for transcatheter aortic valve implantation: the Valve Academic Research Consortium-2 consensus document.
        Eur Heart J. 2012; 33: 2403-2418
        • Vahanian A.
        • et al.
        • Joint Task Force on the Management of Valvular Heart Disease of the European Society of Cardiology (ESC)
        • European Association for Cardio-Thoracic Surgery (EACTS)
        Guidelines on the management of valvular heart disease (version 2012).
        Eur Heart J. 2012; 33: 2451-2496
        • Khan A.R.
        • Khan S.
        • Riaz H.
        • et al.
        Efficacy and safety of transcatheter aortic valve replacement in intermediate surgical risk patients: a systematic review and meta-analysis.
        Catheter Cardiovasc Interv. 2016; 88: 934-944
        • Zhou Y.
        • Wang Y.
        • Wu Y.
        • Zhu J.
        Transcatheter versus surgical aortic valve replacement in low to intermediate risk patients: a meta-analysis of randomized and observational studies.
        Int J Cardiol. 2017; 228: 723-728
        • Siemieniuk R.A.
        • Agoritsas T.
        • Manja V.
        • et al.
        Transcatheter versus surgical aortic valve replacement in patients with severe aortic stenosis at low and intermediate risk: systematic review and meta-analysis.
        BMJ. 2016; 354: i5130
        • Higgins J.P.
        • Altman D.G.
        • Gøtzsche P.C.
        • et al.
        The Cochrane Collaboration's tool for assessing risk of bias in randomised trials.
        BMJ. 2011; 343: d5928
        • Guyatt G.H.
        • Oxman A.D.
        • Vist G.
        • et al.
        GRADE guidelines: 4. Rating the quality of evidence–study limitations (risk of bias).
        J Clin Epidemiol. 2011; 64: 407-415
        • Parmar M.K.
        • Torri V.
        • Stewart L.
        Extracting summary statistics to perform meta-analyses of the published literature for survival endpoints.
        Stat Med. 1998; 17: 2815-2834
        • Hozo S.P.
        • Djulbegovic B.
        • Hozo I.
        Estimating the mean and variance from the median, range, and the size of a sample.
        BMC Med Res Methodol. 2005; 5: 13
        • Wan X.
        • Wang W.
        • Liu J.
        • Tong T.
        Estimating the sample mean and standard deviation from the sample size, median, range and/or interquartile range.
        BMC Med Res Methodol. 2014; 14: 135
        • Higgins J.P.
        • Thompson S.G.
        • Deeks J.J.
        • Altman D.G.
        Measuring inconsistency in meta-analyses.
        BMJ. 2003; 327: 557-560
        • Thyregod H.G.
        • Steinbrüchel D.A.
        • Ihlemann N.
        • et al.
        Transcatheter versus surgical aortic valve replacement in patients with severe aortic valve stenosis: 1-year results from the All-Comers NOTION randomized clinical trial.
        J Am Coll Cardiol. 2015; 65: 2184-2194
        • Nielsen H.H.
        • Klaaborg K.E.
        • Nissen H.
        • et al.
        A prospective, randomised trial of transapical transcatheter aortic valve implantation vs. surgical aortic valve replacement in operable elderly patients with aortic stenosis: the STACCATO trial.
        EuroIntervention. 2012; 8: 383-389
        • Repossini A.
        • Di Bacco L.
        • Passaretti B.
        • et al.
        Early hemodynamics and clinical outcomes of isolated aortic valve replacement with stentless or transcatheter valve in intermediate-risk patients.
        J Thorac Cardiovasc Surg. 2017; 153: 549-558.e3
        • Latib A.
        • Maisano F.
        • Bertoldi L.
        • et al.
        Transcatheter vs surgical aortic valve replacement in intermediate-surgical-risk patients with aortic stenosis: a propensity score-matched case-control study.
        Am Heart J. 2012; 164: 910-917
        • Castrodeza J.
        • Amat-Santos I.J.
        • Blanco M.
        • et al.
        Propensity score matched comparison of transcatheter aortic valve implantation versus conventional surgery in intermediate and low risk aortic stenosis patients: a hint of real-world.
        Cardiol J. 2016; 23: 541-551
        • Osnabrugge R.L.
        • Head S.J.
        • Genders T.S.
        • et al.
        Costs of transcatheter versus surgical aortic valve replacement in intermediate-risk patients.
        Ann Thorac Surg. 2012; 94: 1954-1960
        • Kamperidis V.
        • van Rosendael P.J.
        • de Weger A.
        • et al.
        Surgical sutureless and transcatheter aortic valves: hemodynamic performance and clinical outcomes in propensity score-matched high-risk populations with severe aortic stenosis.
        JACC Cardiovasc Interv. 2015; 8: 670-677
        • Frerker C.
        • Bestehorn K.
        • Schlüter M.
        • et al.
        In-hospital mortality in propensity-score matched low-risk patients undergoing routine isolated surgical or transfemoral transcatheter aortic valve replacement in 2014 in Germany.
        Clin Res Cardiol. 2017; 106: 610-617
        • Fraccaro C.
        • Tarantini G.
        • Rosato S.
        • et al.
        Early and midterm outcome of propensity-matched intermediate-risk patients aged ≥80 years with aortic stenosis undergoing surgical or transcatheter aortic valve replacement (from the Italian multicenter OBSERVANT study).
        Am J Cardiol. 2016; 117: 1494-1501
        • Schymik G.
        • Heimeshoff M.
        • Bramlage P.
        • et al.
        A comparison of transcatheter aortic valve implantation and surgical aortic valve replacement in 1,141 patients with severe symptomatic aortic stenosis and less than high risk.
        Catheter Cardiovasc Interv. 2015; 86: 738-744
        • Piazza N.
        • Kalesan B.
        • Van Mieghem N.
        • et al.
        A 3-center comparison of 1-year mortality outcomes between transcatheter aortic valve implantation and surgical aortic valve replacement on the basis of propensity score matching among intermediate-risk surgical patients.
        JACC Cardiovasc Interv. 2013; 6: 443-451
        • Thourani V.H.
        • Kodali S.
        • Makkar R.R.
        • et al.
        Transcatheter aortic valve replacement versus surgical valve replacement in intermediate-risk patients: a propensity score analysis.
        Lancet. 2016; 387: 2218-2225
        • Tamburino C.
        • Barbanti M.
        • D'Errigo P.
        • et al.
        1-Year outcomes after transfemoral transcatheter or surgical aortic valve replacement: results from the Italian OBSERVANT study.
        J Am Coll Cardiol. 2015; 66: 804-812
        • Rosato S.
        • Santini F.
        • Barbanti M.
        • et al.
        Transcatheter aortic valve implantation compared with surgical aortic valve replacement in low-risk patients.
        Circ Cardiovasc Interv. 2016; 9: e003326
        • Fraccaro C.
        • Al-Lamee R.
        • Tarantini G.
        • et al.
        Transcatheter aortic valve implantation in patients with severe left ventricular dysfunction: immediate and mid-term results, a multicenter study.
        Circ Cardiovasc Interv. 2012; 5: 253-260
        • Adams D.H.
        • Popma J.J.
        • Reardon M.J.
        • et al.
        Transcatheter aortic-valve replacement with a self-expanding prosthesis.
        N Engl J Med. 2014; 370: 1790-1798
        • Kapadia S.
        • Agarwal S.
        • Miller D.C.
        • et al.
        Insights into timing, risk factors, and outcomes of stroke and transient ischemic attack after transcatheter aortic valve replacement in the PARTNER trial (Placement of Aortic Transcatheter Valves).
        Circ Cardiovasc Interv. 2016; 9: e002981
        • Werner N.
        • Zeymer U.
        • Schneider S.
        • et al.
        Incidence and clinical impact of stroke complicating transcatheter aortic valve implantation: results from the German TAVI registry.
        Catheter Cardiovasc Interv. 2016; 88: 644-653
        • Nazif T.M.
        • Dizon J.M.
        • Hahn R.T.
        • et al.
        Predictors and clinical outcomes of permanent pacemaker implantation after transcatheter aortic valve replacement: the PARTNER (Placement of AoRtic TraNscathetER Valves) trial and registry.
        JACC Cardiovasc Interv. 2015; 8: 60-69
        • Kodali S.K.
        • Williams M.R.
        • Smith C.R.
        • et al.
        Two-year outcomes after transcatheter or surgical aortic-valve replacement.
        N Engl J Med. 2012; 366: 1686-1695
        • Athappan G.
        • Patvardhan E.
        • Tuzcu E.M.
        • et al.
        Incidence, predictors, and outcomes of aortic regurgitation after transcatheter aortic valve replacement: meta-analysis and systematic review of literature.
        J Am Coll Cardiol. 2013; 61: 1585-1595
        • Wijeysundera H.C.
        • Li L.
        • Braga V.
        • et al.
        Drivers of healthcare costs associated with the episode of care for surgical aortic valve replacement versus transcatheter aortic valve implantation.
        Open Heart. 2016; 3: e000468