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
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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.
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