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

2021; BMJ; Volume: 107; Issue: 11 Linguagem: Inglês

10.1136/heartjnl-2020-318548

1468-201X

Carlo Tumscitz, A. Di Cesare, Marco Balducelli, Tommaso Piva, Andrea Santarelli, Francesco Saia, Fabio Tarantino, Gerlando Preti, Andrea Picchi, Cristina Rolfo, Tiziana Attisano, Giovanni Colonna, Giuseppe De Iaco, Guido Parodi, Massimo Di Marco, Enrico Cerrato, Simona Pierini, Luca Fileti, Caterina Cavazza, Gianni Dall’Ara, Benedetta Govoni, Giacomo Mantovani, Matteo Serenelli, Carlo Penzo, Matteo Tebaldi, Gianluca Campo, Simone Biscaglia,

Infective Endocarditis Diagnosis and Management

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 .