Intravascular Lithotripsy-Assisted TMVR Shows Promise for Patients With Severe Stenosis and MR in FIH Procedure

January 10, 2023—The Society for Cardiovascular Angiography & Interventions (SCAI) announced the publication of a study that shows promise for intravascular lithotripsy– (IVL–) assisted transcatheter mitral valve replacement (TMVR). The procedure was used to treat a severely calcified mitral valve in a patient with severe stenosis and mitral regurgitation (MR).

Puvi Seshiah, MD, et al published the study online in the society’s journal, Journal of the Society for Cardiovascular Angiography & Interventions. The lead investigator of the study is Dean Kereiakes, MD.

According to SCAI, the investigators treated a male (aged 83 years) who had previously received transcatheter aortic valve replacement for aortic stenosis and had presented with medically refractory dyspnea. He was enrolled in the APOLLO trial of the Intrepid TMVR system (Medtronic).

Transseptal implantation of a 48-mm Intrepid valve was facilitated by Shockwave IVL delivered via two (8- X 60-mm) M5+ balloons (Shockwave Medical) placed across the mitral annulus before implantation. Cerebral embolic protection during IVL and valve implantation was provided by the Sentinel device (Boston Scientific) and left subclavian balloon occlusion, reported SCAI press release.

The investigators found that postdilation achieved valve frame expansion and reduced MR. Postprocedural imaging performed before hospital discharge and at 30 days displayed progressive valve frame expansion in the anteroposterior dimension, increased valve area, and resolution of MR.

“Our team used IVL to modify this severely calcified mitral annulus and valve leaflets to facilitate expansion of the Intrepid self-expanding valve,” commented Dr. Kereiakes in the SCAI press release. “This type of patient is often turned down for catheter-based therapies.” Dr. Kereiakes is Medical Director of The Christ Hospital Heart and Vascular Center, Medical Director of The Christ Hospital Research Institute, and Professor of Clinical Medicine at Ohio State University in Cincinnati, Ohio.

As noted in the SCAI press release, the investigators cautioned that further clinical research and studies are needed before IVL can be considered as a routine accompaniment to TMVR in patients with severe mitral annular and leaflet calcification or before Sentinel and balloon occlusion of the left subclavian can be proven to provide cerebral embolic protection during TMVR.