Initial findings using the V8 hourglass-shaped valvuloplasty balloon for postdilatation in treating paravalvular leaks associated with transcatheter self-expanding aortic valve prosthesis.

OBJECTIVES

The aim of this study was to assess the effect of a novel hourglass-shaped balloon on reduction of paravalvular leak (PVL) in patients undergoing transcatheter aortic valve replacement (TAVR) with self-expanding prostheses.

BACKGROUND

An important limitation of TAVR compared with surgical aortic valve replacement remains the higher incidence of PVL. A commonly used strategy to treat PVL is balloon postdilatation (BPD); however, the optimal technique for treating PVL after TAVR is unknown.

METHODS

We examined consecutive patients with severe, symptomatic aortic stenosis who underwent TAVR with the Medtronic CoreValve followed by BPD with an InterValve V8 balloon for PVL grade ≥2+. Data from echocardiographic, multidetector computed tomographic, and angiographic images were reviewed. The primary endpoint was successful reduction in PVL to grade 1+ or less as assessed by intraprocedural echocardiography.

RESULTS

Eleven patients were studied (median age, 82 years; 64% female). Ten patients (91%) demonstrated successful reduction in PVL after V8 BPD. In three patients, PVL was reduced to zero or trace. PVL remained unchanged in one patient (2+). Two patients had complete heart block associated with valve deployment and received permanent pacemakers. There were no occurrences of annular injury or major adverse clinical events.

CONCLUSIONS

BPD with the V8 hourglass-shaped balloon was feasible in reducing PVL from self-expanding TAVR prostheses. © 2016 Wiley Periodicals, Inc.