Resultados del implante percutáneo de válvula aórtica en España mediante el Registro de Actividad de Atención Especializada

  1. A. Íñiguez Romo 1
  2. Javier Zueco 2
  3. Mercedes Álvarez Bartolomé 3
  4. José A. Baz Alonso 1
  5. Víctor Alfonso Jiménez Díaz 1
  6. Rodrigo Estévez Loureiro 1
  7. Gabriela Veiga Fernández 2
  8. Dae-Jin Lee Hwang 2
  9. Belén Martí Sánchez 4
  10. Jesús Cuervo 5
  1. 1 Servicio de Cardiología, Hospital Álvaro Cunqueiro, Vigo, Pontevedra, España
  2. 2 Servicio de Cardiología, Hospital Universitario Marqués de Valdecilla, Santander, España
  3. 3 Dirección Médica, Hospital Universitario del Henares, Madrid, España
  4. 4 Edwards Lifesciences, Valencia, España
  5. 5 Axentiva Solutions, Barcelona, España
Journal:
REC: Interventional Cardiology

ISSN: 2604-7276 2604-7306

Year of publication: 2022

Volume: 4

Issue: 2

Pages: 123-131

Type: Article

DOI: 10.24875/RECIC.M21000256 DIALNET GOOGLE SCHOLAR lock_openDialnet editor

More publications in: REC: Interventional Cardiology

Abstract

Introduction and objectives: Transcatheter aortic valve implantation (TAVI) has become the treatment of choice for the management of symptomatic severe aortic stenosis. As it happens with all procedures, the safety and effectiveness of TAVI must be monitored. To this end, we assessed the data available from the Spanish National Health Service from 2014 through 2017. Methods: The study included patients aged > 50 years treated with TAVI and registered in the Activity Registry of Specialized Health Care from 2014 through 2017 from public and private hospitals in compliance with the National Health System. Multivariate logistic regression analyses were performed to identify factors associated with mortality and complications, and negative binomial models for the mean hospital length of stay (LoS). Standardized rates were used to discriminate both the effectiveness and safety among regions with higher and lower levels of implementation of the technique using the national median as the threshold, (37 implants x 105 habitants) in the 4-year period. Results: A total of 5454 TAVIs were analyzed. The in-hospital mortality rate dropped from 4.89% in 2014 to 2.7% in 2017. The LoS decreased from 13.1 days in 2014 to 11.3 days in 2017. No differences in mortality were observed among the regions. However, the LoS of regions with a high volume of implants was significantly lower (OR, 0.88; 95%CI, 0.86-0.91; P < .01), as well as the risk of infections (OR, 0.54; 95%CI, 0.32-0.9; P = .02), and pacemaker implantation (OR, 0.77; 95%CI, 0.65-0.91; P < .01). Conclusions: The use of TAVI in Spain is safe and has grown progressively with improved outcomes regarding morbidity and mortality. Differences among regions have been highlighted regarding patient access to TAVI. This heterogeneity was not associated with mortality but with differences in the morbidity rates.

Bibliographic References

  • 1. Ferreira-González I, Pinar-Sopena J, Ribera A, et al. Prevalence of calcific aortic valve disease in the elderly and associated risk factors:a population-based study in a Mediterranean area. Eur J Preventive Cardiol. 2013;20:1022-1030.
  • 2. Salinas P, Moreno R, Calvo L, et al. Seguimiento a largo plazo tras implante percutáneo de válvula aórtica por estenosis aórtica grave. Rev Esp Cardiol. 2016;69:37-44.
  • 3. Izquierdo-Gómez MM, Hernández-Betancor I, García-Niebla J, Marí-López B, Laynez-Cerdeña I, Lacalzada-Almeida J. Valve Calcification in Aortic Stenosis:Etiology and Diagnostic Imaging Techniques. BioMed Res Int. 2017;5178:1-12.
  • 4. Stewart BF, Siscovick D, Lind BK, et al. Clinical Factors Associated With Calcific Aortic Valve Disease fn1fn1This study was supported in part by Contracts NO1-HC85079 through HC-850086 from the National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, Maryland. J Am Coll Cardiol. 1997;29:630-634.
  • 5. Ramaraj R, Sorrell VL. Degenerative aortic stenosis. BMJ. 2008;336:550-555.
  • 6. Otto CM, Lind BK, Kitzman DW, Gersh BJ, Siscovick DS. Association of Aortic-Valve Sclerosis with Cardiovascular Mortality and Morbidity in the Elderly. N Engl J Med. 1999;341:142-147.
  • 7. INE. Nota de prensa 20 de octubre de 2016. Proyecciones de Población 2016-2066. 2016;2066. Disponible en: https://www.ine.es/prensa/np994.pdf. Consultado 29 Jun 2020.
  • 8. Thaden JJ, Nkomo VT, Enriquez-Sarano M. The Global Burden of Aortic Stenosis. Prog Cardiovasc Dis. 2014;56:565-571.
  • 9. Leon MB, Smith CR, 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.
  • 10. Duncan A, Ludman P, Banya W, et al. Long-term outcomes after transcatheter aortic valve replacement in high-risk patients with severe aortic stenosis:the U.K. Transcatheter Aortic Valve Implantation Registry. JACC Cardiovasc Interv. 2015;8:645-653.
  • 11. Baumgartner H, Falk V, Bax JJ, et al. 2017 ESC/EACTS Guidelines for the management of valvular heart disease. Eur Heart J. 2017;38:2739-2791.
  • 12. Mack MJ, Leon MB, Thourani VH, et al. Transcatheter Aortic-Valve Replacement with a Balloon-Expandable Valve in Low-Risk Patients. N Engl J Med. 2019;380:1695-1705.
  • 13. Popma JJ, Deeb GM, Yakubov SJ, et al. Transcatheter Aortic-Valve Replacement with a Self-Expanding Valve in Low-Risk Patients. N Engl J Med. 2019;380:1706-1715.
  • 14. Biagioni C, Tirado-Conte G, Nombela-Franco L, et al. Situación actual del implante transcatéter de válvula aórtica en España. Rev Esp Cardiol. 2017;70(Supl 1):6-8.
  • 15. Ministerio de Sanidad, Consumo y Bienestar Social. Grupos Relacionados de Diagnóstico APR-GRD V32. Norma Estatal 2017;2019. Disponible en: https://www.mscbs.gob.es/estadEstudios/estadisticas/docs/CMBD/Nota_difus_Norma_Estatal_2017.pdf. Consultado 3 Jul 2020.
  • 16. Subdirección General de Información Sanitaria e Innovación. Ministerio de Sanidad, Servicios Sociales e Igualdad. Norma Estatal RAE-CMBD 2016 –NotaInformativa;2018. Disponible en: https://www.mscbs.gob.es/estadEstudios/estadisticas/docs/CMBD/Nota_difus_Norma_Estatal_2016.pdf. Consultado 29 Jun 2020.
  • 17. Instituto Nacional de Estadística. Tablas de Mortalidad por Año, Comunidades y Ciudades Autónomas, Sexo, Edad y Funciones. Disponible en: https://www.ine.es/jaxiT3/Tabla.htm?t=27154&L=0. Consultado 29 Jun 2020.
  • 18. Calcagno V, de Mazancourt C. glmulti:An R Package for Easy Automated Model Selection with (Generalized) Linear Models. J Statistical Software. 2010;34:1-29.
  • 19. Castrodeza J, Amat-Santos IJ, 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.
  • 20. Sardar P, Kundu A, Chatterjee S, et al. Transcatheter versus surgical aortic valve replacement in intermediate-risk patients:Evidence from a meta-analysis. Catheter Cardiovasc Interv. 2017;90:504-515.
  • 21. Khan SU, Lone AN, Saleem MA, Kaluski E. Transcatheter vs surgical aortic-valve replacement in low- to intermediate-surgical-risk candidates:A meta-analysis and systematic review. Clin Cardiol. 2017;40:974-981.
  • 22. Sección de Hemodinámica y Cardiología Intervencionista. Sociedad Española de Cardiología. Registro Nacional de Actividad en Cardiología Intervencionista 2017;2018. Disponible en: https://www.hemodinamica.com/wp-content/uploads/2018/11/PRESENTACIO%CC%81N-DEFINITIVA-REGISTRO-2017.pdf. Consultado 27 Jun 2020.
  • 23. European Society of Cardiology. Women less likely to die after TAVI than men. Published online 2013. Disponible en: https://www.escardio.org/The-ESC/Press-Office/Press-releases/Women-less-likely-to-die-after-TAVI-than-men. Consultado 29 Jun 2020.
  • 24. Carnero-Alcázar M, Maroto-Castellanos LC, Hernández-Vaquero D, et al. Isolated aortic valve replacement in Spain:national trends in risks, valve types, and mortality from 1998 to 2017. Rev Esp Cardiol. 2021;74:700-707.
  • 25. Deharo P, Bisson A, Herbert J, et al. Impact of Sapien 3 Balloon-Expandable Versus Evolut R Self-Expandable Transcatheter Aortic Valve Implantation in Patients With Aortic Stenosis:Data From a Nationwide Analysis. Circulation. 2020;141:260-268.
  • 26. Goicolea Ruigómez FJ, Elola FJ, Durante-López A, Fernández Pérez C, Bernal JL, Macaya C. Coronary artery bypass grafting in Spain. Influence of procedural volume on outcomes. Rev Esp Cardiol. 2020;73:488-494.
  • 27. Íñiguez Romo A, Bertomeu Martínez V, Rodríguez Padial L, et al. The RECALCAR Project. Healthcare in the Cardiology Units of the Spanish National Health System, 2011 to 2014. Rev Esp Cardiol. 2017;70:567-575.
  • 28. Ministerio de Sanidad. El Ministerio de Sanidad traslada a las CCAA el borrador de la Estrategia en Salud Cardiovascular del SNS. Disponible en: https://www.mscbs.gob.es/gabinete/notasPrensa.do?id=4993. Consultado 20 Oct 2020.
  • 29. Ribera A, Slof J, Andrea R, et al. Transfemoral transcatheter aortic valve replacement compared with surgical replacement in patients with severe aortic stenosis and comparable risk:Cost-utility and its determinants. International J Cardiol. 2015;182:321-328.
  • 30. Baron SJ, Wang K, House JA, et al. Cost-Effectiveness of Transcatheter Versus Surgical Aortic Valve Replacement in Patients With Severe Aortic Stenosis at Intermediate Risk. Circulation. 2019;139:877-888.