Article Text

Download PDFPDF
Original research
Safety, efficacy and impact on frailty of mini-invasive radial balloon aortic valvuloplasty
  1. Carlo Tumscitz1,
  2. Annamaria Di Cesare1,
  3. Marco Balducelli2,
  4. Tommaso Piva3,
  5. Andrea Santarelli4,
  6. Francesco Saia5,
  7. Fabio Tarantino6,
  8. Gerlando Preti7,
  9. Andrea Picchi8,
  10. Cristina Rolfo9,
  11. Tiziana Attisano10,
  12. Giuseppe Colonna11,
  13. Giuseppe De Iaco12,
  14. Guido Parodi13,
  15. Massimo Di Marco14,
  16. Enrico Cerrato9,
  17. Simona Pierini15,
  18. Luca Fileti2,
  19. Caterina Cavazza4,
  20. Gianni Dall'Ara6,
  21. Benedetta Govoni16,
  22. Giacomo Mantovani16,
  23. Matteo Serenelli1,
  24. Carlo Penzo1,
  25. Matteo Tebaldi1,
  26. Gianluca Campo17,
  27. Simone Biscaglia1
  1. 1Cardiology Unit, Azienda Ospedaliero Universitaria di Ferrara Arcispedale Sant'Anna, Cona, Emilia-Romagna, Italy
  2. 2Cardiovascular Department, Azienda Unità Sanitaria Locale della Romagna, Ospedale Santa Maria delle Croci, Ravenna, Italy
  3. 3Cardiology Unit, Ospedali Riuniti Umberto I – GM Lancisi, Ancona, Italy
  4. 4Cardiology Unit, Infermi Hospital, Rimini, Italy
  5. 5Cardiology Unit, Cardio-Thoracic-Vascular Department, University of Bologna, Policlinico S.Orsola-Malpighi, Bologna, Italy
  6. 6Cardiology Unit, ASL Romagna via Forlanini 34, Forlì, Italy
  7. 7Cardiac Unit, Aulss 2 Marca Trevigiana, Ospedale civile, Conegliano Veneto (TV), Italy
  8. 8Cardiovascular Department, Azienda USL Toscana SudEst, Misericordia Hospital, Grosseto, Italy
  9. 9Interventional Cardiology Unit, San Luigi Gonzaga University Hospital, Orbassano and Rivoli Infermi Hospital, Rivoli (TO), Italy
  10. 10Interventional Cardiology Unit, Heart Department, AOU S.Giovanni di Dio e Ruggi D’Aragona (SA), Salerno, Italy
  11. 11Interventional Cardiology Unit, V. Fazzi Hospital, Lecce, Italy
  12. 12Interventional Cardiology, AO Cardinal G Panico, Tricase (LE), Italy
  13. 13Clinica Cardiologica, Azienda Ospedaliero-Universitaria di Sassari, Sassari, Italy
  14. 14Cardiac Unit, Santo Spirito Hospital, Pescara, Italy
  15. 15Cardiovascular Department, ASST Nord Milano – Bassini Hospital, Cinisello Balsamo (MI), Italy, Cinisello Balsamo, Italy
  16. 16Department of Medical Sciences, Ferrara University, Ferrara, Italy
  17. 17Department of Medical Sciences, Cardiology Unit, Azienda Ospedaliera Universitaria di Ferrara, Cona (FE), Italy
  1. Correspondence to Dr Simone Biscaglia, Medical Sciences, Cardiology Unit, Azienda Ospedaliera Universitaria di Ferrara, 44124 Ferrara, Italy; simone.biscaglia{at}gmail.com

Abstract

Objective The study was designed to: (1) confirm safety and feasibility of mini-invasive radial balloon aortic valvuloplasty (BAV); (2) assess its impact in terms of quality of life and frailty; and (3) evaluate whether changes in frailty after BAV are associated with death in patients undergoing transcatheter aortic valve implantation (TAVI).

Methods 330 patients undergoing BAV in 16 Italian centres were prospectively included. The primary endpoint was the occurrence of major and minor Valve Academic Research Consortium (VARC)-2 bleeding. Secondary endpoints were scales of quality of life, frailty, evaluated at baseline and 30 days, and their relationship with the occurrence of all-cause death.

Results BAV was performed by radial access in 314 (95%) patients. No VARC-2 major and six (1.8%) VARC-2 minor bleedings occurred in the study population. Quality of life, as well as frailty status, significantly improved 30 days after BAV. At 1 year, patients undergoing TAVI with baseline essential frailty toolset (EFT) <3 or achieving an EFT <3 after BAV had a comparable occurrence of all-cause death (15% vs 19%, p=0.58). On the contrary, patients with EFT ≥3 at 30 days despite BAV showed the worst prognosis (all-cause death: 40% vs 15% and 19%, p=0.006 and p=0.05, respectively).

Conclusions Mini-invasive radial BAV is safe, feasible and associated with a low rate of vascular complications. Patients improving EFT 30 days after BAV showed a favourable outcome after TAVI.

Trial registration number NCT03087552.

  • aortic valve stenosis
  • transcatheter aortic valve replacement

Statistics from Altmetric.com

Footnotes

  • Twitter @matser89, @SimoneBiscaglia

  • Contributors Planning: SB, GC, CT, CP and MT. Conduct: CT, ADC, MB, TP, AS, FS, FT, GP, AP, CR, TA, GiuC, GDI, GP, MDM, EC, SP, LF, CC, GD, BG, GM, CP, MT, GiaC and SB. Reporting: MS, CT, ADC, MB, TP, AS, FS, FT, GeP, AP, CR, TA, GiuC, GDI, GuP, MDM, EC, SP, LF, CC, GA, BG, GM, CP, MT, GiaC and SB.

  • Competing interests None declared.

  • Patient consent for publication Not required.

  • Ethics approval This investigator-driven clinical study was approved by the participating hospitals’ ethical review boards.

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

  • Data availability statement Data are available upon reasonable request.

  • Author note The study was an investigator-driven clinical trial conducted by the University of Ferrara.

  • 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.

Request Permissions

If you wish to reuse any or all of this article please use the link below which will take you to the Copyright Clearance Center’s RightsLink service. You will be able to get a quick price and instant permission to reuse the content in many different ways.

Linked Articles