Lithotripsy-Assisted Transcatheter Mitral Valve Replacement for Severe Mitral Annular and Valve Calcification.

BACKGROUND

Transcatheter mitral valve replacement (TMVR) is evolving; however, limitations include severe calcification of the mitral valve leaflets and mitral annular calcification (MAC), which may be associated with incomplete valve expansion. Shockwave intravascular lithotripsy (IVL)-assisted percutaneous mitral valvuloplasty to treat calcific mitral stenosis has been reported. We describe the first human use of IVL-assisted transseptal TMVR with the Intrepid valve to treat a severely calcified mitral valve in a patient with severe stenosis and regurgitation.

METHODS

An 83-year-old man with rheumatic heart disease and severe MAC (MAC score, 10; calcium volume score, 7756 cm) presented with combined mitral stenosis and regurgitation (valve area, 1.5 cm; 3+ mitral regurgitation [MR]) and medically refractory heart failure symptoms and was enrolled into the APOLLO (Transcatheter Mitral Valve Replacement With the Medtronic Intrepid TMVR System in Patients With Severe Symptomatic Mitral Regurgitation) trial of Intrepid valve TMVR. Transseptal implantation of a 48-mm Intrepid valve was facilitated by Shockwave IVL delivered via two 8.0 × 60-mm M5+ balloons placed across the mitral annulus before implantation. Cerebral embolic protection during IVL and valve implant was provided by a Sentinel device and left subclavian balloon occlusion.

RESULTS

Despite initial postimplant valve frame deformation and moderate central MR, postdilation achieved valve frame expansion and reduced MR. Echocardiography and computed tomography performed before hospital discharge and at 30 days show progressive valve frame expansion in the anteroposterior dimension, increased valve area, and resolution of MR.

CONCLUSIONS

Intravascular lithotripsy of severe MAC before self-expanding TMVR may enhance annular compliance, mitigate fibroelastic recoil, and minimize TMVR valve frame deformation. Although promising, further study is required before IVL is considered a routine adjunct for TMVR in severe MAC.