Lithotripsy of Calcified Aortic Valve Leaflets by a Novel Ultrasound Transcatheter-Based Device

Abstract

The increasing incidence of calcific aortic valve disease necessitates the elaboration of new strategies to retard the progression of the pathology with an innovative solution. While the increasing diffusion of the transcatheter aortic valve replacements (TAVRs) allows a mini-invasive approach to aortic valve substitution as an alternative to conventional surgical replacement (SAVR) in an always larger patient population, TAVR implantation still has contraindications for young patients. In addition, it is liable to undergo calcification with the consequent necessity of re-intervention with conventional valve surgery or repeated implantation in the so-called TAVR-in-TAVR procedure. Inspired by applications for non-cardiac pathologies or for vascular decalcification before stenting (i.e., coronary lithotripsy), in the present study, we show the feasibility of human valve treatment with a mini-invasive device tailored to deliver shockwaves to the calcific leaflets. We provide evidence of efficient calcium deposit ruptures in human calcified leaflets treated ex vivo and the safety of the treatment in pigs. The use of this device could be helpful to perform shockwaves valvuloplasty as an option to retard TAVR/SAVR, or as a pretreatment to facilitate prosthesis implantation and minimize the occurrence of paravalvular leak.

Review of intravascular lithotripsy for treating coronary, peripheral artery, and valve calcifications

“…77 Another approach for treating aortic stenosis is the use of transcatheter debridement device (TDD). 78 It uses low-intensity ultrasound shockwaves for calcium fracture in the native aortic or bioprosthetic valves with the aim of restoring the leaflet pliability to regain an adequate flow as an alternative to TAVR. Using a combination of different frequencies, 100 kHz and 3 MHz.…”

“…There are two reported cases where one undersized 7 mm balloon 76 and another with simultaneous use of three 7 mm balloons were needed to allow passage of larger balloons 77 . Another approach for treating aortic stenosis is the use of transcatheter debridement device (TDD) 78 . It uses low‐intensity ultrasound shockwaves for calcium fracture in the native aortic or bioprosthetic valves with the aim of restoring the leaflet pliability to regain an adequate flow as an alternative to TAVR.…”