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

Abstract

P ercutaneous balloon pulmonary valvuloplasty (BPV), first described by Kan and colleagues 1 in 1982, has replaced surgical valvotomy as the preferred treatment for congenital and acquired pulmonary valve stenosis (PVS).2,3 Many patients have had satisfactory long-term results after BPV, but conventional balloon designs have limited effectiveness when pulmonary valve (PV) annular diameters range from 18 to 30 mm; in some cases, effective balloon diameters >30 mm are needed. Cylindrical balloons as large as 30 mm in diameter are commercially available; however, they have several drawbacks, including slow inf lation times, which can prolong systemic hypotension; difficulty maintaining catheter position during systole with the potential for intracardiac trauma; and low nominal burst pressures. 4Attempts 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. 4-8The 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. In contrast, the V8 balloon is semicompliant and retains its shape throughout inflation. The waist and bulbous segments reach predetermined diameters at specified volume-driven inf lations. The waist diameter increases through incremental stepwise inf lations.Although the V8 balloon has provided good results in BAV procedures, its use has not been reported for BPV. 9 We describe our successful experience with the V8 balloon in 3 patients with PVS, and we detail our balloon sizing technique. Device DesignThe distal end of the V8 balloon catheter system features an hourglass-shaped dilation balloon (Fig. 1). Three radiopaque markers on the catheter shaft correspond to the center of the waist segment and to the distal and proximal shoulders of the bulbous balloon segments (Fig. 2). The length of the fully inf lated balloon is 32 mm: the waist segment is 12 mm, and each of the bulbous segments is 10 mm. The waist segment is more compliant than the bulbous segments, so it expands to a greater degree. The TechniquesTeoman Kilic, MD