Abstract
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.
Similar content being viewed by others
References
European Commission (2014) The 2015 ageing report: underlying assumptions and projection methodologies. 8:1–413. http://ec.europa.eu/economy_finance/publications/european_economy/2014/pdf/ee8_en.pdf. Accessed 29 Feb 2016
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 25:522–528
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
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 31:427–433
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) 11:897–909
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 66:804–812
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:R31
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
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:b2535
Tierney JF, Stewart LA, Ghersi D, Burdett Sarah, Sydes MR (2007) Practical methods for incorporating summary time-to-event data into meta-analysis. Trials 8:16
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 100:74–80
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 100:1261–1267
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 100:785–793
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 24:750–755
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 98:1593–1597
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 67:583–584
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 12:80
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 116:1110–1115
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 62:189–190
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 97:29–36
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 110:1156–1163
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 148:509–514
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 17:365–375
Davis JP, LaPar DJ, Crosby IK, Kern JA, Lau CL, Kron IL, Ailawadi G (2014) Nonagenarians undergoing cardiac surgery. J Card Surg 29:600–604
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 117:245–251
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 174:165–170
Acknowledgements
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.
Author information
Authors and Affiliations
Corresponding author
Ethics declarations
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.
Additional information
On behalf of the OBSERVANT Research Group.
Members of OBSERVANT Research Group are listed in Acknowledgements.
Rights and permissions
About this article
Cite this article
Biancari, F., D’Errigo, P., Rosato, S. et al. Transcatheter aortic valve replacement in nonagenarians: early and intermediate outcome from the OBSERVANT study and meta-analysis of the literature. Heart Vessels 32, 157–165 (2017). https://doi.org/10.1007/s00380-016-0857-3
Received:
Accepted:
Published:
Issue Date:
DOI: https://doi.org/10.1007/s00380-016-0857-3