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Original research
Early clinical and haemodynamic matched comparison of balloon-expandable valves
  1. Jose R Delgado-Arana1,
  2. María X Gordillo-Monge2,
  3. Jonathan Halim3,
  4. Federico De Marco4,
  5. Carlo Trani5,
  6. Pedro Martin6,
  7. Fabio Infusino7,
  8. Marco Ancona8,
  9. Peter den Heijer3,
  10. Francesco Bedogni9,
  11. Luis Nombela Franco10,11,
  12. Raul Moreno12,
  13. Gennaro Sargella7,
  14. Matteo Montorfano13,
  15. Cristhian Aristizabal-Duque1,
  16. Teresa Romero-Delgado2,
  17. Sandra Santos14,
  18. Alejandro Barrero15,
  19. Itziar Gomez Salvador16,
  20. Sander IJsselmuiden3,
  21. Alfredo Redondo Diéguez17,18,
  22. José Alberto San Román Calvar19,
  23. Ignacio J Amat-Santos20
  1. 1Cardiology Depatment, Valladolid University Hospital, Valladolid, Castilla y León, Spain
  2. 2Cardiology Department, San Carlos University Hospital, Madrid, Spain
  3. 3Cardiology Department, Amphia Hospital, Breda, North Brabant, Netherlands
  4. 4Cardiology Department, Ospedale Niguarda Ca'Granda, Milan, Italy
  5. 5Department of Cardiovascular Medecine, Policlinico Universitario Agostino Gemelli, Rome, Italy
  6. 6Cardiology Department, Hospital Universitario de Gran Canaria Dr. Negrin, Las Palmas de Gran Canaria, Las Palmas, Spain
  7. 7Cardiology Department, Umberto I Policlinico di Roma, Roma, Lazio, Italy
  8. 8Cardiology Department, Istituto Scientifico Universitario San Raffaele, Milano, Lombardia, Italy
  9. 9Istituto Clinico S. Ambrogio, Department of Cardiology IRCCS San Donato, Milan, Italy
  10. 10Interventional Cardiology, Hospital Clinico Universitario San Carlos, Madrid, Spain
  11. 11Cardiology, Institut Universitaire de Cardiologie et de Pneumologie de Quebec, Quebec City, Quebec, Canada
  12. 12Interventional Cardiology, University Hospital La Paz, Madrid, Spain
  13. 13Interventional Cardiology, San Raffaele Scientific Institute, Milan, Italy
  14. 14Cardiology, Hospital Clinico Universitario de Valladolid, Valladolid, Valladolid, Spain
  15. 15Interventional Cardiology, Valladolid University Hospital, Valladolid, Castilla y León, Spain
  16. 16Biostatistics Department, Institute of Heart Sciences—ICICOR- University Hospital, Valladolid, Spain, Valladolid, Spain
  17. 17Cardiovascular, Royal Brompton Hospital, London, UK
  18. 18Servicio de Cardiología y Unidad Coronaria, Complejo Hospitalario Universitario de Santiago de Compostela, Santiago de Compostela, A Coruña, Spain
  19. 19Cardiology, Hospital Clinico Universitario de Valladolid, Valladolid, Spain
  20. 20Cardiology, Universitary Clinical Hospital, Valladolid, Spain
  1. Correspondence to Dr Ignacio J Amat-Santos, Cardiology, University Clinic Hospital of Valladolid (3, Ramon y Cajal), Valladolid, 47005, Spain; ijamat{at}gmail.com

Abstract

Objectives The balloon-expandable Sapien-3 valve demonstrated superior results in terms of residual aortic regurgitation when compared with self-expandable devices. We aimed to compare for the first-time early outcomes of Sapien-3 transcatheter heart valve (THV) with the balloon-expandable Myval device.

Methods Consecutive real-world patients from nine European institutions with symptomatic severe aortic stenosis treated either with Sapien-3 or Myval THV devices after June 2018 were compared. Early clinical outcomes were prospectively gathered and blinded analysis of 30-day echocardiography was conducted. Matching for the following variables was performed: age, body surface area, Society of Thoracic Surgeons risk score, left ventricular function, mean gradient, transfemoral approach, aortic valvular calcium, aortic annulus mean diameter, area and eccentricity index.

Results A total of 416 patients treated either with the Sapien-3 (n=286, 68.7%) or with Myval THV (n=130, 31.3%) were included and 103 pairs compared after matching. Baseline characteristics were similar. Procedural success rate (Sapien-3: 94.2%; Myval: 93.2%, p=0.219), 30-day mortality (Sapien-3: 2.9%; Myval: 0.97%, p=0.625), clinical efficacy (12.6 vs 4.9%, p=0.057) and early safety (12.6 vs 4.9%, p=0.096) were comparable. There was a lower need for new permanent pacemaker (15.5 vs 5.8% p=0.020) with Myval. No significant differences were found in terms of ≥moderate aortic regurgitation (1% for Sapien-3, 0% for Myval, p=0.314), but mean gradients were higher following Sapien-3 than after Myval (p<0.001).

Conclusions The new Myval balloon-expandable THV was favourable in terms of safety, with low rate of permanent pacemaker and with favourable residual gradients and paravalvular leak rate according to blinded echocardiographic analysis.

  • transcatheter aortic valve replacement
  • aortic valve stenosis

Data availability statement

All data relevant to the study are included in the article or uploaded as supplementary information. All investigators have access to the database and the central pool of echocardiographic analysis. Due to research aims of monitoring all the information is available on request.

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Data availability statement

All data relevant to the study are included in the article or uploaded as supplementary information. All investigators have access to the database and the central pool of echocardiographic analysis. Due to research aims of monitoring all the information is available on request.

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Footnotes

  • Twitter @drassantos, @alexbarreroMD, @Alfredo_Redondo, @ignamatsant

  • Contributors JRDA and IJAS designed the project, collected and analysed the information and wrote the final manuscript. MXGM, JH, FDM, CT, PM, FI, MA, PdH, FB, LNF, RM, SS, MM, CA-D, TR-D, GS, AB, IGS, SI, ARD and JASRC helped to collect data, performed critical review and approved the final version of the manuscript.

  • Funding The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.

  • Competing interests None declared.

  • Provenance and peer review Not commissioned; internally peer reviewed.

  • Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.

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