Safety, efficacy and impact on frailty of mini-invasive radial balloon aortic valvuloplasty

Author:

Tumscitz Carlo,Di Cesare Annamaria,Balducelli Marco,Piva Tommaso,Santarelli Andrea,Saia Francesco,Tarantino Fabio,Preti Gerlando,Picchi Andrea,Rolfo Cristina,Attisano Tiziana,Colonna Giuseppe,De Iaco Giuseppe,Parodi GuidoORCID,Di Marco Massimo,Cerrato Enrico,Pierini Simona,Fileti Luca,Cavazza Caterina,Dall'Ara Gianni,Govoni Benedetta,Mantovani Giacomo,Serenelli MatteoORCID,Penzo Carlo,Tebaldi Matteo,Campo GianlucaORCID,Biscaglia SimoneORCID

Abstract

ObjectiveThe 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).Methods330 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.ResultsBAV 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).ConclusionsMini-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 numberNCT03087552.

Publisher

BMJ

Subject

Cardiology and Cardiovascular Medicine

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