Pulmonary valvuloplasty in adults using the Inoue balloon catheter

Abstract

This report describes a new balloon pulmonary valvuloplasty technique using the Inoue balloon catheter performed in 14 consecutive adult patients, aged 17-47 years (mean 27). The mean right ventricular systolic pressure and the pulmonary valvular peak-to-peak systolic gradient decreased from 102 +/- 41 to 52 +/- 19 mm Hg (p = 0.001) and 81 +/- 40 to 7 +/- 7 mm Hg (p = 0.0002), respectively. An infundibular peak-to-peak systolic gradient either developed (n = 13) or increased (n = 1). None of the patients were treated with beta-adrenergic blockers before or after the valvuloplasty. Eight patients underwent repeat hemodynamic study 12-30 months (mean 17) after treatment, and had no evidence of valvular restenosis. The mean right ventricular systolic pressure and the mean infundibular peak-to-peak systolic gradient decreased, compared to the values immediately after valvuloplasty (54 to 40 mm Hg, p = 0.03, and 28 to 10 mm Hg, p = 0.03, respectively). The study suggests that pulmonary valvuloplasty in adults using the Inoue balloon catheter technique is feasible, safe, and effective.

New Pulmonary Valvuloplasty Technique by Use of an Hourglass-Shaped Balloon in 3 Adults with Severe Pulmonary Valve Stenosis

“…The decreases in our patients' gradients were similar to those after BPV with other types of balloons. [5][6][7][8]10 Early after treatment, all of our patients had residual systolic gradients, but these continued to improve during the followup period. All 3 patients were prescribed β-adrenergic blocker therapy after intervention; it was useful in each case, but was especially beneficial to Patients 1 and 2 because of their infundibular hypertrophy and presumed systolic gradient contributing to RV and PA stenosis.…”

“…4 To minimize these problems, double-balloon, tripleballoon, and Inoue-balloon techniques have been developed, but they have ultimately offered little benefit at increased costs. [4][5][6][7][8] Using smaller balloons for double-balloon valvuloplasty theoretically facilitates insertion, manipulation, and removal of the balloon catheters while reducing vascular trauma at the insertion site. However, the technique necessitates additional femoral venous access and increases the risk of associated complications.…”

“…4 The Inoue balloon reportedly improves hemodynamics; however, it is compliant, and it loses its hourglass shape during maximal inf lation, which places the PV annulus, the STJ, and the leaf lets at risk of rupture. 7,8,[10][11][12] Moreover, it can be difficult to manipulate.…”

“…4 Attempts to minimize these problems through the use of double balloons, triple balloons, and the Inoue Balloon (Toray Industries, Inc.) have been described, but these procedures are cumbersome, time-consuming, and expensive. [4][5][6][7][8] The V8 Aortic Valvuloplasty Balloon Catheter (InterValve Medical, Inc.; acquired by Venus Medtech in 2017) 9 is an hourglass-shaped balloon with 2 bulbous segments, separated by a narrowed waist. During balloon aortic valvuloplasty (BAV), the design improves fixation and enables better leaf let opening without compromising the annulus.…”

“…The Inoue balloon also has an hourglass shape, and investigators have reported better BAV outcomes with it than with cylindrical balloons. 7,8,10 However, it has a large sheath and rigid properties. 11,12 Moreover, the Inoue is a compliant, low-inf lation pressure balloon, and its hourglass shape disappears during peak inf lation.…”