Heart and Vessels

, Volume 32, Issue 2, pp 157–165 | Cite as

Transcatheter aortic valve replacement in nonagenarians: early and intermediate outcome from the OBSERVANT study and meta-analysis of the literature

  • Fausto Biancari
  • Paola D’ErrigoEmail author
  • Stefano Rosato
  • Marek Pol
  • Corrado Tamburino
  • Marco Ranucci
  • Fulvia Seccareccia
Original Article


The purpose of this study was to evaluate the outcome of nonagenarians after transcatheter aortic valve replacement (TAVR) from the OBSERVANT study and to pool the results of the literature on this topic. Aortic stenosis is the most common acquired valvular heart disease in the Western countries, and its prevalence is linked to the phenomenon of population aging. TAVR can be considered as a wise approach to treat nonagenarians, but data on its safety and effectiveness are scarce. Data on 80 patients aged >90 years who underwent TAVR from OBSERVANT study were analyzed. A systematic review and meta-analysis of published data were performed. Thirty-day mortality in the OBSERVANT series was 6.3 %. None of these patients experienced stroke. Permanent pacemaker implantation was necessary in 20 % of patients. Paravalvular regurgitation was observed in 57.5 %. Survival at 1, 2, and 3 years was 79.6, 71.9, and 61.5 %. Ten series provided data on 1227 nonagenarians who underwent TAVR. Pooled 30-day mortality rate was 7.1 %, stroke 2.8 %, vascular access complication 8.8 %, and permanent pacemaker implantation 10.6 %. Paravalvular regurgitation was observed in 60.1 % of patients. Pooled 1-, 2-, and 3-year survival rates were 79.2, 68.2, and 55.6 %. Transapical TAVR was associated with a significantly higher risk of early mortality compared with transfemoral TAVR. The results of OBSERVANT study and aggregate data meta-analysis suggest that in nonagenarians, TAVR is associated with low postoperative morbidity and excellent intermediate survival. Transapical TAVR in these very elderly is associated with high postoperative mortality.


Aortic valve stenosis Transcatheter aortic valve implantation Transcatheter aortic valve replacement TAVI TAVR Nonagenarian 90 years 



The OBSERVANT Study was supported by a Grant (Fasc. 1M30) from Italian Ministry of Health and Istituto Superiore di Sanità. The authors thank Gabriella Badoni for her technical support in the organizational phases of the study. Fulvia Seccareccia, Paola D’Errigo, Stefano Rosato, Alice Maraschini, Gabriella Badoni, National Center for Epidemiology, Surveillance and Health Promotion-ISS; Corrado Tamburino, Marco Barbanti, SICI-GISE, Gennaro Santoro, FIC, ANMCO; Francesco Santini, Francesco Onorati, Claudio Grossi, SICCH; Marco Ranucci, Remo Daniel Covello, ITACTA; Danilo Fusco, Epidemiology Department Lazio Region; Rossana De Palma, Emilia Romagna Region; Salvatore Scondotto, Sicilia Region.

Compliance with ethical standards

Conflict of interest

Prof. Tamburino receives honorary fees from Medtronic and Abbott; there is no potential conflict of interest related to the matter of the article for any other author.


  1. 1.
    European Commission (2014) The 2015 ageing report: underlying assumptions and projection methodologies. 8:1–413. Accessed 29 Feb 2016
  2. 2.
    Aoyagi S, Fukunaga S, Arinaga K, Tomoeda H, Akasu K, Ueda T (2010) Heart valve surgery in octogenarians: operative and long-term results. Heart Vessels 25:522–528CrossRefPubMedGoogle Scholar
  3. 3.
    Cappabianca G, Ferrarese S, Musazzi A, Terrieri F, Corazzari C, Matteucci M, Beghi C (2016) Predictive factors of long-term survival in the octogenarian undergoing surgical aortic valve replacement: 12-year single-centre follow-up. Heart Vessels. doi: 10.1007/s00380-016-0804-3 PubMedGoogle Scholar
  4. 4.
    Biancari F, Barbanti M, Santarpino G, Deste W, Tamburino C, Gulino S, Immè S, Di Simone E, Todaro D, Pollari F, Fischlein T, Kasama K, Meuris B, Dalén M, Sartipy U, Svenarud P, Lahtinen J, Heikkinen J, Juvonen T, Gatti G, Pappalardo A, Mignosa C, Rubino AS (2016) Immediate outcome after sutureless versus transcatheter aortic valve replacement. Heart Vessels 31:427–433CrossRefPubMedGoogle Scholar
  5. 5.
    Gruppo di Lavoro tecnico dello studio OBSERVANT, D’Errigo P, Fusco D, Grossi C, Ramondo AB, Ranucci M, Santini F, Santoro G, Seccareccia F, Tamburino C (2010) OBSERVANT: observational study of appropriateness, efficacy and effectiveness of AVR-TAVI procedures for the treatment of severe symptomatic aortic stenosis. Study protocol. G Ital Cardiol (Rome) 11:897–909Google Scholar
  6. 6.
    Tamburino C, Barbanti M, D’Errigo P, Ranucci M, Onorati F, Covello RD, Santini F, Rosato S, Santoro G, Fusco D, Grossi C, Seccareccia F, OBSERVANT Research Group (2015) 1-year outcomes after transfemoral transcatheter or surgical aortic valve replacement: results from the Italian OBSERVANT study. J Am Coll Cardiol 66:804–812CrossRefPubMedGoogle Scholar
  7. 7.
    Mehta RL, Kellum JA, Shah SV, Molitoris BA, Ronco C, Warnock DG, Levin A (2007) Acute kidney injury network: report of an initiative to improve outcomes in acute kidney injury. Crit Care 11:R31CrossRefPubMedPubMedCentralGoogle Scholar
  8. 8.
    D’Errigo P, Moretti C, D’Ascenzo F, Rosato S, Biancari F, Barbanti M, Santini F, Ranucci M, Miceli A, Tamburino C, Onorati F, Santoro G, Grossi C, Fusco D, Seccareccia F, on behalf of the OBSERVANT Research Group (2016) Transcatheter aortic valve implantation versus surgical aortic valve replacement for severe aortic stenosis in patients with chronic kidney disease stages 3b-5. Ann Thorac Surg. doi: 10.1016/j.athoracsur.2016.01.109 PubMedGoogle Scholar
  9. 9.
    Moher D, Liberati A, Tetzlaff J, Altman DG, PRISMA Group (2009) Preferred reporting items for systematic reviews and meta-analyses: the PRISMA statement. BMJ 339:b2535CrossRefPubMedPubMedCentralGoogle Scholar
  10. 10.
    Tierney JF, Stewart LA, Ghersi D, Burdett Sarah, Sydes MR (2007) Practical methods for incorporating summary time-to-event data into meta-analysis. Trials 8:16CrossRefPubMedPubMedCentralGoogle Scholar
  11. 11.
    Mack MC, Szerlip M, Herbert MA, Akram S, Worley C, Kim RJ, Prince BA, Harrington KB, Mack MJ, Holper EM (2015) Outcomes of treatment of nonagenarians with severe aortic stenosis. Ann Thorac Surg 100:74–80CrossRefPubMedGoogle Scholar
  12. 12.
    Kayatta MO, Thourani VH, Jensen HA, Condado JC, Sarin EL, Kilgo PD, Devireddy CM, Leshnower BG, Mavromatis K, Li C, Guyton RA, Stewart JP, Simone A, Keegan P, Block P, Lerakis S, Babaliaros VC (2015) Outcomes for transcatheter aortic valve replacement in nonagenarians. Ann Thorac Surg 100:1261–1267CrossRefPubMedGoogle Scholar
  13. 13.
    Thourani VH, Jensen HA, Babaliaros V, Kodali SK, Rajeswaran J, Ehrlinger J, Blackstone EH, Suri RM, Don CW, Aldea G, Williams MR, Makkar R, Svensson LG, McCabe JM, Dean LS, Kapadia S, Cohen DJ, Pichard AD, Szeto WY, Herrmann HC, Devireddy C, Leshnower BG, Ailawadi G, Maniar HS, Hahn RT, Leon MB, Mack M (2015) Outcomes in nonagenarians undergoing transcatheter aortic valve replacement in the PARTNER-I Trial. Ann Thorac Surg 100:785–793CrossRefPubMedGoogle Scholar
  14. 14.
    Noble S, Frangos E, Samaras N, Ellenberger C, Frangos C, Cikirikcioglu M, Bendjelid K, Frei A, Myers P, Licker M, Roffi M (2013) Transcatheter aortic valve implantation in nonagenarians: effective and safe. Eur J Intern Med 24:750–755CrossRefPubMedGoogle Scholar
  15. 15.
    Murashita T, Greason KL, Suri RM, Nkomo VT, Holmes DR, Rihal CS, Mathew V (2014) Aortic valve replacement for severe aortic valve stenosis in the nonagenarian patient. Ann Thorac Surg 98:1593–1597CrossRefPubMedGoogle Scholar
  16. 16.
    Pascual I, López-Otero D, Muñoz-García AJ, Alonso-Briales JH, Avanzas P, Morís C (2014) Safety and efficacy of transcatheter aortic valve implantation in nonagenarian patients. Rev Esp Cardiol 67:583–584CrossRefPubMedGoogle Scholar
  17. 17.
    Akin I, Kische S, Paranskaya L, Schneider H, Rehders TC, Turan GR, Divchev D, Kundt G, Bozdag-Turan I, Ortak J, Birkemeyer R, Nienaber CA, Ince H (2012) Morbidity and mortality of nonagenarians undergoing CoreValve implantation. BMC Cardiovasc Disord 12:80CrossRefPubMedPubMedCentralGoogle Scholar
  18. 18.
    Abramowitz Y, Chakravarty T, Jilaihawi H, Kashif M, Zadikany R, Lee C, Matar G, Cheng W, Makkar RR (2015) Comparison of outcomes of transcatheter aortic valve implantation in patients ≥90 versus <90 years. Am J Cardiol 116:1110–1115CrossRefPubMedGoogle Scholar
  19. 19.
    Verouhis D, Yamasaki K, Ivert T, Rück A, Settergren M (2014) Transcatheter aortic valve implantation is feasible and safe in nonagenarians. J Am Geriatr Soc 62:189–190CrossRefPubMedGoogle Scholar
  20. 20.
    Yamamoto M, Mouillet G, Meguro K, Gilard M, Laskar M, Eltchaninoff H, Fajadet J, Iung B, Donzeau-Gouge P, Leprince P, Leuguerrier A, Prat A, Lievre M, Chevreul K, Dubois-Rande JL, Teiger E, FRANCE-2 Registry Investigators (2014) Clinical results of transcatheter aortic valve implantation in octogenarians and nonagenarians: insights from the FRANCE-2 registry. Ann Thorac Surg 97:29–36CrossRefPubMedGoogle Scholar
  21. 21.
    Yamamoto M, Meguro K, Mouillet G, Bergoend E, Monin JL, Lim P, Dubois-Rande JL, Teiger E (2012) Comparison of effectiveness and safety of transcatheter aortic valve implantation in patients aged ≥90 versus <90 years. Am J Cardiol 110:1156–1163CrossRefPubMedGoogle Scholar
  22. 22.
    Indraratna P, Ang SC, Gada H, Yan TD, Manganas C, Bannon P, Cao C (2014) Systematic review of the cost-effectiveness of transcatheter aortic valve implantation. J Thorac Cardiovasc Surg 148:509–514CrossRefPubMedGoogle Scholar
  23. 23.
    Eaton J, Mealing S, Thompson J, Moat N, Kappetein P, Piazza N, Busca R, Osnabrugge R (2014) Is transcatheter aortic valve implantation (TAVI) a cost-effective treatment in patients who are ineligible for surgical aortic valve replacement? A systematic review of economic evaluations. J Med Econ 17:365–375CrossRefPubMedGoogle Scholar
  24. 24.
    Davis JP, LaPar DJ, Crosby IK, Kern JA, Lau CL, Kron IL, Ailawadi G (2014) Nonagenarians undergoing cardiac surgery. J Card Surg 29:600–604CrossRefPubMedGoogle Scholar
  25. 25.
    Biancari F, Rosato S, D’Errigo P, Ranucci M, Onorati F, Barbanti M, Santini F, Tamburino C, Santoro G, Grossi C, Covello RD, Ventura M, Fusco D, Seccareccia F, on behalf of the OBSERVANT Research Group (2016) Immediate and intermediate outcome after transapical versus transfemoral transcatheter aortic valve replacement. Am J Cardiol 117:245–251CrossRefPubMedGoogle Scholar
  26. 26.
    Takagi H, Umemoto T, ALICE (All-Literature Investigation of Cardiovascular Evidence) Group (2014) A meta-analysis of adjusted observational studies for mortality in transapical versus transfemoral aortic valve implantation. Int J Cardiol 174:165–170CrossRefPubMedGoogle Scholar

Copyright information

© Springer Japan 2016

Authors and Affiliations

  • Fausto Biancari
    • 1
  • Paola D’Errigo
    • 2
    Email author
  • Stefano Rosato
    • 2
  • Marek Pol
    • 3
  • Corrado Tamburino
    • 4
  • Marco Ranucci
    • 5
  • Fulvia Seccareccia
    • 2
  1. 1.Department of SurgeryOulu University HospitalOuluFinland
  2. 2.National Center for Epidemiology, Surveillance and Health PromotionIstituto Superiore di SanitàRomeItaly
  3. 3.First Faculty of Medicine, Institute of AnatomyCharles University in PraguePragueCzech Republic
  4. 4.Division of Cardiology, Ferrarotto HospitalUniversity of CataniaCataniaItaly
  5. 5.Department of Cardiothoracic and Vascular AnesthesiaICU-IRCCS Policlinico San DonatoSan Donato MilaneseItaly

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