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Transcatheter versus surgical aortic valve replacement in low- and intermediate-risk patients: an updated systematic review and meta-analysis

  • Daisuke Ueshima
  • Luca Nai Fovino
  • Gianpiero D’Amico
  • Sorin J. Brener
  • Giovanni Esposito
  • Giuseppe TarantiniEmail author
Original Article

Abstract

Transcatheter aortic valve replacement (TAVR) has been recognized as a well-established alternative to surgical aortic valve replacement (SAVR) for symptomatic aortic stenosis with high surgical risk. With this updated systematic review and meta-analysis, we evaluated TAVR vs. SAVR in low- and intermediate-risk subjects. Studies comparing TAVR and SAVR in low-risk patients (defined as STS ≤ 8% or EuroSCORE ≤ 20%) were identified with electronic searches. The principal endpoint was all-cause mortality at short term (< 3 months), 1, and 2 years. Other outcomes of interest were cardiac mortality, neurological events, paravalvular leakage (PVL), myocardial infarction (MI), major bleeding, acute kidney injury (AKI), vascular complications, and new pacemaker (PM) implantation. Seventeen articles including 9805 (4956 TAVR and 4849 SAVR) patients were eligible. There was no significant difference in all-cause mortality at short term [odds ratio (OR) 0.83, 95% confidence interval (CI) 0.63–1.09], 1 year (OR 1.01, 95% CI 0.86–1.20) and 2 years (OR 0.86, 95% CI 0.64–1.16) between treatment groups. Subgroup analyses stratified by surgical risk score (low-risk subgroup: STS < 4% or EuroSCORE < 10%, intermediate-risk subgroup: the others) did not show interaction on primary endpoints. Compared to SAVR, TAVR had similar rates of neurological events, significantly lower risk of MI and AKI, but higher risk of vascular complications, new PM implantation and moderate/severe PVL. In low- and intermediate-risk patients, TAVR and SAVR have similar short- and mid-term all-cause mortality. Compared to SAVR, TAVR carries higher rates of vascular complications, PM implantation and moderate/severe PVL, but lower risk of MI and AKI.

Keywords

Severe aortic stenosis Transcatheter aortic valve replacement Surgical aortic valve replacement Low risk Intermediate risk 

Notes

Compliance with ethical standards

Conflict of interest

G Tarantini received lecture fees from Edwards Lifesciences, Medtronic and Boston Scientifics. The other authors have no relevant conflict of interest to disclose.

Supplementary material

12928_2018_546_MOESM1_ESM.pdf (3.2 mb)
Supplementary material 1 (PDF 3282 kb)

References

  1. 1.
    Nishimura RA, Otto CM, Bonow RO, Carabello BA, Erwin JP, Guyton RA, et al. 2014 AHA/ACC guideline for the management of patients with valvular heart disease: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. J Am Coll Cardiol. 2014;63:e57–185.CrossRefGoogle Scholar
  2. 2.
    Nishimura RA, Otto CM, Bonow RO, Carabello BA, Erwin JP, 3rd, Fleisher LA, et al. 2017 AHA/ACC Focused Update of the 2014 AHA/ACC Guideline for the Management of Patients With Valvular Heart Disease: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. J Am Coll Cardiol. 2017.Google Scholar
  3. 3.
    Thyregod HG, Steinbruchel DA, Ihlemann N, Nissen H, Kjeldsen BJ, Petursson P, 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;65:2184–94.CrossRefGoogle Scholar
  4. 4.
    Leon MB, Smith CR, Mack MJ, Makkar RR, Svensson LG, Kodali SK, et al. Transcatheter or surgical aortic-valve replacement in intermediate-risk patients. N Engl J Med. 2016;374:1609–20.CrossRefGoogle Scholar
  5. 5.
    Reardon MJ, Van Mieghem NM, Popma JJ, Kleiman NS, Sondergaard L, Mumtaz M, et al. Surgical or transcatheter aortic-valve replacement in intermediate-risk patients. N Engl J Med. 2017;376:1321–31.CrossRefGoogle Scholar
  6. 6.
    Tamburino C, Barbanti M, D’Errigo P, Ranucci M, Onorati F, Covello RD, et al. 1-year outcomes after transfemoral transcatheter or surgical aortic valve replacement: results from the Italian OBSERVANT Study. J Am Coll Cardiol. 2015;66:804–12.CrossRefGoogle Scholar
  7. 7.
    Frerker C, Bestehorn K, Schluter M, Bestehorn M, Hamm CW, Mollmann H, 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.Google Scholar
  8. 8.
    Nishimura RA, Otto CM, Bonow RO, Carabello BA, Erwin JP, Fleisher LA, et al. 2017 AHA/ACC Focused Update of the 2014 AHA/ACC Guideline for the Management of Patients With Valvular Heart Disease: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. Circulation. 2017.Google Scholar
  9. 9.
    Petronio AS, Capranzano P, Barbato E, Piazza N, Baumbach A, Haude M, et al. Current status of transcatheter valve therapy in Europe: results from an EAPCI survey. EuroIntervention. 2016;12:890–5.CrossRefGoogle Scholar
  10. 10.
    Moher D, Liberati A, Tetzlaff J, Altman DG, Group P. Preferred reporting items for systematic reviews and meta-analyses: the PRISMA statement. BMJ. 2009;339:b2535.CrossRefGoogle Scholar
  11. 11.
    Stroup DF, Berlin JA, Morton SC, Olkin I, Williamson GD, Rennie D, et al. Meta-analysis of observational studies in epidemiology: a proposal for reporting. meta-analysis of observational studies in epidemiology (MOOSE) group. JAMA. 2000;283:2008–12.CrossRefGoogle Scholar
  12. 12.
    Higgins JP, Altman DG, Gøtzsche PC, Jüni P, Moher D, Oxman AD, et al. The Cochrane Collaboration’s tool for assessing risk of bias in randomised trials. BMJ. 2011;343:d5928.CrossRefGoogle Scholar
  13. 13.
    Kim SY, Park JE, Lee YJ, Seo HJ, Sheen SS, Hahn S, et al. Testing a tool for assessing the risk of bias for nonrandomized studies showed moderate reliability and promising validity. J Clin Epidemiol. 2013;66:408–14.CrossRefGoogle Scholar
  14. 14.
    Search strategy used to create the systematic reviews subset on PubMed. U.S. National Library of Medicine; 2018.Google Scholar
  15. 15.
    DerSimonian R, Laird N. Meta-analysis in clinical trials. Control Clin Trials. 1986;7:177–88.CrossRefGoogle Scholar
  16. 16.
    Higgins JP, Thompson SG. Quantifying heterogeneity in a meta-analysis. Stat Med. 2002;21:1539–58.CrossRefGoogle Scholar
  17. 17.
    Tully PJ, Roshan P, Rice GD, Sinhal A, Bennetts JS, Baker RA. Change in quality of life after transcatheter aortic valve implantation and aortic valve replacement surgery in Australian patients aged >/= 75 years: the effects of EuroSCORE and patient operability. J Geriatr Cardiol. 2015;12:30–6.Google Scholar
  18. 18.
    Macon C, Singh V, O’Neill B, Kattan CG, Tanawuttiwat T, Lucero T, et al. Transcatheter aortic valve replacement versus surgical aortic valve replacement in a low to intermediate risk population. ACC 142017.Google Scholar
  19. 19.
    Abdul-Jawad Altisent O, Ferreira-Gonzalez I, Marsal JR, Ribera A, Auger C, Ortega G, et al. Neurological damage after transcatheter aortic valve implantation compared with surgical aortic valve replacement in intermediate risk patients. Clin Res Cardiol. 2016;105:508–17.CrossRefGoogle Scholar
  20. 20.
    Tokarek T, Sobczynski R, Dziewierz A, Siudak Z, Zasada W, Sorysz D, et al. Clinical outcomes in patients after surgical and transcatheter aortic valve replacement. Pol Arch Med Wewn. 2015;125:755–64.Google Scholar
  21. 21.
    Latib A, Maisano F, Bertoldi L, Giacomini A, Shannon J, Cioni M, 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;164:910–7.CrossRefGoogle Scholar
  22. 22.
    Osnabrugge RL, Head SJ, Genders TS, Van Mieghem NM, De Jaegere PP, van der Boon RM, et al. Costs of transcatheter versus surgical aortic valve replacement in intermediate-risk patients. Ann Thorac Surg. 2012;94:1954–60.CrossRefGoogle Scholar
  23. 23.
    Schymik G, Heimeshoff M, Bramlage P, Herbinger T, Wurth A, Pilz L, 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;86:738–44.CrossRefGoogle Scholar
  24. 24.
    Bestehorn K, Bestehorn M, Fleck E. Influence of different approaches of aortic valve replacement on the incidence of post-operative delirium in intermediate risk patients—a matched pair analysis. Curr Med Res Opin. 2015;31:2157–63.CrossRefGoogle Scholar
  25. 25.
    Castrodeza J, Amat-Santos IJ, Blanco M, Cortes C, Tobar J, Martin-Morquecho I, 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;23:541–51.Google Scholar
  26. 26.
    Hannan EL, Samadashvili Z, Stamato NJ, Lahey SJ, Wechsler A, Jordan D, et al. Utilization and 1-year mortality for transcatheter aortic valve replacement and surgical aortic valve replacement in New York patients with aortic stenosis: 2011 to 2012. JACC Cardiovasc Interv. 2016;9:578–85.CrossRefGoogle Scholar
  27. 27.
    Nielsen HH, Klaaborg KE, Nissen H, Terp K, Mortensen PE, Kjeldsen BJ, 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;8:383–9.CrossRefGoogle Scholar
  28. 28.
    Reardon MJ, Adams DH, Kleiman NS, Yakubov SJ, Coselli JS, Deeb GM, et al. 2-year outcomes in patients undergoing surgical or self-expanding transcatheter aortic valve replacement. J Am Coll Cardiol. 2015;66:113–21.CrossRefGoogle Scholar
  29. 29.
    Cribier A, Eltchaninoff H, Bash A, Borenstein N, Tron C, Bauer F, et al. Percutaneous transcatheter implantation of an aortic valve prosthesis for calcific aortic stenosis: first human case description. Circulation. 2002;106:3006–8.CrossRefGoogle Scholar
  30. 30.
    Leon MB, Smith CR, Mack M, Miller DC, Moses JW, Svensson LG, et al. Transcatheter aortic-valve implantation for aortic stenosis in patients who cannot undergo surgery. N Engl J Med. 2010;363:1597–607.CrossRefGoogle Scholar
  31. 31.
    Thourani VH, Kodali S, Makkar RR, Herrmann HC, Williams M, Babaliaros V, et al. Transcatheter aortic valve replacement versus surgical valve replacement in intermediate-risk patients: a propensity score analysis. Lancet. 2016;387:2218–25.CrossRefGoogle Scholar
  32. 32.
    Kodali S, Thourani VH, White J, Malaisrie SC, Lim S, Greason KL, et al. Early clinical and echocardiographic outcomes after SAPIEN 3 transcatheter aortic valve replacement in inoperable, high-risk and intermediate-risk patients with aortic stenosis. Eur Heart J. 2016;37:2252–62.CrossRefGoogle Scholar
  33. 33.
    Cohen DJ. Health status benefits of transcatheter vs. surgical aortic valve replacement in patients with severe aortic stenosis at intermediate surgical risk. TCT2016.Google Scholar
  34. 34.
    Babaliaros V, Devireddy C, Lerakis S, Leonardi R, Iturra SA, Mavromatis K, et al. Comparison of transfemoral transcatheter aortic valve replacement performed in the catheterization laboratory (minimalist approach) versus hybrid operating room (standard approach): outcomes and cost analysis. JACC Cardiovasc Interv. 2014;7:898–904.CrossRefGoogle Scholar
  35. 35.
    Miller DC, Blackstone EH, Mack MJ, Svensson LG, Kodali SK, Kapadia S, et al. Transcatheter (TAVR) versus surgical (AVR) aortic valve replacement: occurrence, hazard, risk factors, and consequences of neurologic events in the PARTNER trial. J Thorac Cardiovasc Surg. 2012;143(832–43):e13.Google Scholar
  36. 36.
    Messe SR, Acker MA, Kasner SE, Fanning M, Giovannetti T, Ratcliffe SJ, et al. Stroke after aortic valve surgery: results from a prospective cohort. Circulation. 2014;129:2253–61.CrossRefGoogle Scholar
  37. 37.
    Athappan G, Patvardhan E, Tuzcu EM, Svensson LG, Lemos PA, Fraccaro C, 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;61:1585–95.CrossRefGoogle Scholar
  38. 38.
    Wendler O, Schymik G, Treede H, Baumgartner H, Dumonteil N, Ihlberg L, et al. SOURCE 3 registry: design and 30-day results of the european postapproval registry of the latest generation of the SAPIEN 3 transcatheter heart valve. Circulation. 2017;135:1123–32.CrossRefGoogle Scholar
  39. 39.
    Rampat R, Khawaja MZ, Byrne J, MacCarthy P, Blackman DJ, Krishnamurthy A, et al. Transcatheter aortic valve replacement using the repositionable LOTUS valve: United Kingdom experience. JACC Cardiovasc Interv. 2016;9:367–72.CrossRefGoogle Scholar
  40. 40.
    Genereux P, Head SJ, Van Mieghem NM, Kodali S, Kirtane AJ, Xu K, et al. Clinical outcomes after transcatheter aortic valve replacement using valve academic research consortium definitions: a weighted meta-analysis of 3,519 patients from 16 studies. J Am Coll Cardiol. 2012;59:2317–26.CrossRefGoogle Scholar
  41. 41.
    Barbanti M, Binder RK, Freeman M, Wood DA, Leipsic J, Cheung A, et al. Impact of low-profile sheaths on vascular complications during transfemoral transcatheter aortic valve replacement. EuroIntervention. 2013;9:929–35.CrossRefGoogle Scholar
  42. 42.
    Moat N, Brecker S. Transfemoral TAVI is superior to SAVR in elderly high-risk patients with symptomatic severe aortic stenosis! Eur Heart J. 2016;37:3513–4.CrossRefGoogle Scholar
  43. 43.
    Buellesfeld L, Stortecky S, Heg D, Hausen S, Mueller R, Wenaweser P, et al. Impact of permanent pacemaker implantation on clinical outcome among patients undergoing transcatheter aortic valve implantation. J Am Coll Cardiol. 2012;60:493–501.CrossRefGoogle Scholar
  44. 44.
    Nazif TM, Dizon JM, Hahn RT, Xu K, Babaliaros V, Douglas PS, 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;8:60–9.CrossRefGoogle Scholar
  45. 45.
    Ferguson TB Jr, Dziuban SW Jr, Edwards FH, Eiken MC, Shroyer AL, Pairolero PC, et al. The STS national database: current changes and challenges for the new millennium. Committee to Establish a National Database in Cardiothoracic Surgery, The Society of Thoracic Surgeons. Ann Thorac Surg. 2000;69:680–91.CrossRefGoogle Scholar
  46. 46.
    Nashef SA, Roques F, Michel P, Gauducheau E, Lemeshow S, Salamon R. European system for cardiac operative risk evaluation (EuroSCORE). Eur J Cardiothorac Surg. 1999;16:9–13.CrossRefGoogle Scholar
  47. 47.
    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;228:723–8.CrossRefGoogle Scholar
  48. 48.
    Debonnaire P, Fusini L, Wolterbeek R, Kamperidis V, van Rosendael P, van der Kley F, et al. Value of the &quot;TAVI2-SCORe&quot; versus surgical risk scores for prediction of 1 year mortality in 511 patients who underwent transcatheter aortic valve implantation. Am J Cardiol. 2015;115:234–42.CrossRefGoogle Scholar

Copyright information

© Japanese Association of Cardiovascular Intervention and Therapeutics 2018

Authors and Affiliations

  • Daisuke Ueshima
    • 1
  • Luca Nai Fovino
    • 1
  • Gianpiero D’Amico
    • 1
  • Sorin J. Brener
    • 2
  • Giovanni Esposito
    • 3
  • Giuseppe Tarantini
    • 1
    • 4
    Email author
  1. 1.Cardiology Unit, Department of Cardiac, Thoracic and Vascular SciencesUniversity of Padua Medical SchoolPaduaItaly
  2. 2.Department of Medicine, Cardiac Catheterization LaboratoryNew York Methodist HospitalNew YorkUSA
  3. 3.Division of Cardiology, Department of Advanced Biomedical SciencesUniversity of Naples Federico IINaplesItaly
  4. 4.Clinica CardiologicaOspedale di Padova, Centro Cardiologico GallucciPaduaItaly

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