Key result
Retrograde INOUE-BALLOON use without rapid ventricular pacing significantly reduced the incidence of prolonged hypotension after balloon aortic valvuloplasty compared to conventional balloons (4% vs. 16%, OR 0.27).
Why the study?
Rapid ventricular pacing is commonly used during TAVR but frequent pacing is linked to worse outcomes, prompting evaluation of the retrograde INOUE-BALLOON for BAV without rapid pacing.
Does retrograde INOUE-BALLOON without rapid ventricular pacing reduce prolonged hypotension after balloon aortic valvuloplasty in patients undergoing transcatheter aortic valve replacement?
Observational (n=178)
No
Does retrograde INOUE-BALLOON without rapid ventricular pacing reduce prolonged hypotension after balloon aortic valvuloplasty in patients undergoing transcatheter aortic valve replacement?
May reduce prolonged hypotension after BAV; hypothesis-generating for IB without rapid pacing in TAVR.
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/m2vs. 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.
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Ninomiya et al. (2021) conducted an observational in Symptomatic severe aortic stenosis (n=178). Retrograde INOUE-BALLOON without rapid ventricular pacing vs. Conventional balloon with rapid ventricular pacing was evaluated on Prolonged hypotension after balloon aortic valvuloplasty (reduced systolic pressure < 80 mmHg for over 1 min or vasopressor drug requirement) (OR 0.27, 95% CI 0.059-0.952, p=0.041). Retrograde INOUE-BALLOON use without rapid ventricular pacing significantly reduced the incidence of prolonged hypotension after balloon aortic valvuloplasty compared to conventional balloons (4% vs. 16%, OR 0.27).
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