Safety and feasibility of retrograde INOUE-BALLOON for balloon aortic valvuloplasty without rapid ventricular pacing during transcatheter aortic valve replacement

Ryo Ninomiya,Yu Ishikawa,Atsushi Tashiro,Tetsuya Fusazaki,Akiko Kumagai,Yorihiko Koeda,Yoshihiro Morino,Fumiaki Takahashi,Masaru Ishida,Michiko Yoshizawa,Hajime Kin

doi:10.1007/s12928-021-00789-0

Ryo Ninomiya, Yu Ishikawa + Show 9 more

Open Access

https://doi.org/10.1007/s12928-021-00789-0

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Abstract

Rapid ventricular pacing (RVP) is commonly employed during transcatheter aortic valve replacement (TAVR); however, frequent TAVR is associated with worse prognoses. The retrograde INOUE-BALLOON® (IB) allows balloon aortic valvuloplasty (BAV) without RVP. The aim of this study was to evaluate the feasibility of retrograde IB for TAVR preparation. The study population included 178 consecutive patients (mean age, 84 ± 5 years; male, 47%) who underwent retrograde BAV before prosthetic valve replacement via the transfemoral approach. Patients were divided into a retrograde IB group without RVP (n = 74) and a conventional balloon (CB) group with RVP (n = 104). The primary endpoint was prolonged hypotension after BAV (reduced systolic pressure < 80 mmHg for over 1 min or vasopressor drug requirement). The incidence of prolonged hypotension after BAV was significantly lower in the IB group compared with the CB group (4% vs. 16%, p = 0.011). Balloons were able to penetrate and expand the aortic valve in both groups. RVP was used less for total TAVR in the IB group compared with the CB group. The aortic valve area-index after BAV was not significantly different between the two groups (0.72 ± 0.14 cm2/m2 vs. 0.71 ± 0.12 cm2/m2; p = 0.856). Multivariate analysis demonstrated that IB use was associated with avoidance of prolonged hypotension (OR, 0.27 [0.059–0.952]; p = 0.041). In conclusion, BAV using retrograde IB without RVP is both safe and feasible. More stable hemodynamics were achieved using retrograde IB by avoiding RVP during TAVR.

Highlights

Methods for transcatheter aortic valve replacement (TAVR) are rapidly evolving with major refinements in technology, procedural techniques, patient selection, and biomedical engineering
Baseline echocardiography showed no significant differences in peak aortic velocity, mean pressure gradient, ejection fraction, severe aortic regurgitation (AR), and severe mitral regurgitation between the two groups, while the AVA-I was significantly smaller in the IB group
The major findings are as follows: (1) retrograde IB was successfully performed without Rapid ventricular pacing (RVP) for all patients, (2) retrograde IB provided a similar capability for aortic valve expansion to conventional balloon (CB), and (3) retrograde IB was less likely to cause systemic hypotension immediately after balloon dilation

Summary

Introduction

Methods for transcatheter aortic valve replacement (TAVR) are rapidly evolving with major refinements in technology, procedural techniques, patient selection, and biomedical engineering. TAVR has become much simpler and safer, and, with expanding indications, an increasing number of younger patients are being referred for TAVR. TAVR has been used extensively, the development of safer and more precise procedures is essential. Common step during TAVR, is associated with prolonged hypotension and unstable hemodynamics. Frequent RVP is associated with worse prognoses [1,2,3]. Balloon aortic valvuloplasty (BAV) before TAVR is not necessary for all patients but some patients require balloon dilation before prosthetic valve replacement

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