Feasibility and safety of parallel Shockwave® balloon percutaneous mitral valvuloplasty for degenerative mitral stenosis

Abstract

Introduction and objectives

Degenerative mitral valve stenosis (DMS) associated with mitral annular calcification (MAC) poses significant diagnostic and therapeutic challenges. Surgical treatment and conventional percutaneous mitral commissurotomy are often contraindicated, and alternative transcatheter options remain limited and associated with high morbidity and mortality. Lithotripsy-assisted balloon valvuloplasty has recently emerged as a novel percutaneous strategy for selected patients. The objective of this article is to report on an initial feasibility and safety experience of lithotripsy-assisted balloon valvuloplasty without the use of noncompliant balloon post-dilatation.

Methods

We conducted a prospective, single-center study including consecutive patients with symptomatic severe DMS deemed unsuitable for surgery who underwent lithotripsy-assisted balloon valvuloplasty between August and October 2025. The cases were performed under conscious sedation using intracardiac echocardiography guidance. The procedure consisted of a single transseptal puncture accommodating two deflectable sheaths and simultaneous dual-balloon intravascular lithotripsy, without adjunctive noncompliant balloon valvuloplasty. The primary endpoint was technical success according to the Mitral Valve Academic Research Consortium criteria. Safety endpoints included 30-day major procedure-related morbidity and mortality.

Results

Three patients (median age 73 years; 67% female) underwent lithotripsy-assisted balloon valvuloplasty. Median baseline noninvasive and invasive transmitral mean gradients were 16 mmHg and 11 mmHg, respectively, decreasing to 7 mmHg after lithotripsy-assisted balloon valvuloplasty. No worsening of baseline mitral regurgitation was observed. There were no major periprocedural complications; one patient experienced a transient, self-limited period of junctional rhythm.

Conclusions

This proof-of-concept study of lithotripsy-assisted balloon valvuloplasty using a dual deflectable sheath, dual-balloon lithotripsy strategy was feasible and safe in selected patients with DMS. This approach may represent a promising therapeutic option for patients with limited alternatives, warranting further investigation in larger prospective studies.