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

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.

Impact of balloon predilatation in patients with reduced versus preserved ejection fraction during transcatheter aortic valve implantation

“…Furthermore, aortic stenosis patients with preserved EF usually have left ventricular hypertrophy, impaired relaxation, and reduced left ventricular capacity which may make them vulnerable to prolonged hypotension immediately after RVP. 15…”

“…Also, patients with pre-existent low flow-low gradient aortic stenosis, severe aortic regurgitation, severe left ventricular systolic dysfunction, or severe pulmonary hypertension may be at high risk of acute decompensation and hemodynamic instability after predilatation. 9,15…”

“…14 Furthermore, aortic stenosis patients with preserved EF usually have left ventricular hypertrophy, impaired relaxation, and reduced left ventricular capacity which may make them vulnerable to prolonged hypotension immediately after RVP. 15 Also, patients with pre-existent low flow-low gradient aortic stenosis, severe aortic regurgitation, severe left ventricular systolic dysfunction, or severe pulmonary hypertension may be at high risk of acute decompensation and hemodynamic instability after predilatation. 9,15 On the other hand, Witzke et al 14 studied the outcomes of RVP during predilatation and stated that predilatation using RVP is feasible and safe.…”

Combination Use of Inoue-Balloon and Self-Expandable Transcatheter Valves in Managing Aortic Stenosis Not Amenable to Balloon-Expandable Valves

“…Inoue-Balloon catheter: The Inoue-Balloon catheter is a redesigned transcatheter balloon for performing retrograde balloon aortic valvuloplasty. 12) It is currently available in 5 sizes: 18, 20, 22 (10 Fr equivalent), 24 (11 Fr equivalent), and 26 mm (12 Fr equivalent); it is adjustable to target diameters of up to -2 mm to the labeled balloon size with adequate balloon pressure (e.g., a 20 mm balloon can be adjusted to 18-20 mm) 15) (Figure 2). In this study, the initial balloon was determined based on the size of the minimal annular diameter in addition to the burden of calcification of the aortic valve on preprocedural CT.…”

“…10) The aortic Inoue-Balloon catheter (Toray, Tokyo, Japan) is a transcatheter balloon used for performing retrograde balloon valvuloplasty, modified from the original Inoue-Balloon, initially designed in the 1980s for performing percutaneous mitral valve commissurotomy. 11,12) It is stable during dilation and contains a size-adjustable balloon. It is currently commercially available; however, data on the feasibility and safety of the combined use of the Inoue-Balloon and self-expandable transcatheter valves for TAVR are scarce.…”