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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. 1 Cardiology Unit, Azienda Ospedaliero Universitaria di Ferrara Arcispedale Sant'Anna, Cona, Emilia-Romagna, Italy
  2. 2 Cardiovascular Department, Azienda Unità Sanitaria Locale della Romagna, Ospedale Santa Maria delle Croci, Ravenna, Italy
  3. 3 Cardiology Unit, Ospedali Riuniti Umberto I – GM Lancisi, Ancona, Italy
  4. 4 Cardiology Unit, Infermi Hospital, Rimini, Italy
  5. 5 Cardiology Unit, Cardio-Thoracic-Vascular Department, University of Bologna, Policlinico S.Orsola-Malpighi, Bologna, Italy
  6. 6 Cardiology Unit, ASL Romagna via Forlanini 34, Forlì, Italy
  7. 7 Cardiac Unit, Aulss 2 Marca Trevigiana, Ospedale civile, Conegliano Veneto (TV), Italy
  8. 8 Cardiovascular Department, Azienda USL Toscana SudEst, Misericordia Hospital, Grosseto, Italy
  9. 9 Interventional Cardiology Unit, San Luigi Gonzaga University Hospital, Orbassano and Rivoli Infermi Hospital, Rivoli (TO), Italy
  10. 10 Interventional Cardiology Unit, Heart Department, AOU S.Giovanni di Dio e Ruggi D’Aragona (SA), Salerno, Italy
  11. 11 Interventional Cardiology Unit, V. Fazzi Hospital, Lecce, Italy
  12. 12 Interventional Cardiology, AO Cardinal G Panico, Tricase (LE), Italy
  13. 13 Clinica Cardiologica, Azienda Ospedaliero-Universitaria di Sassari, Sassari, Italy
  14. 14 Cardiac Unit, Santo Spirito Hospital, Pescara, Italy
  15. 15 Cardiovascular Department, ASST Nord Milano – Bassini Hospital, Cinisello Balsamo (MI), Italy, Cinisello Balsamo, Italy
  16. 16 Department of Medical Sciences, Ferrara University, Ferrara, Italy
  17. 17 Department 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

Data availability statement

Data are available upon reasonable request.

Statistics from Altmetric.com

Data availability statement

Data are available upon reasonable request.

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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.

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

  • 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.

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