Intravascular lithotripsy before transcatheter mitral valve replacement may be feasible
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Employing intravascular lithotripsy facilitated transcatheter mitral valve replacement in a patient with severe mitral annular and mitral valve leaflet calcification, according to a report on a first-in-human procedure.
The first-in-human use of intravascular lithotripsy (IVL)-assisted transcatheter mitral valve replacement (TMVR) to treat a severely calcified mitral valve was reported in the Journal of the Society for Cardiovascular Angiography and Interventions.
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The procedure was performed on an 83-year-old man who had rheumatic heart disease, severe mitral stenosis, severe mitral regurgitation, severe mitral annular calcification and severe mitral valve leaflet calcification, the researchers wrote.
“Our team used IVL to modify this severely calcified mitral annulus and valve leaflets to facilitate expansion of the Intrepid self-expanding valve,” Dean Kereiakes, MD, MSCAI, medical director of The Christ Hospital Heart and Vascular Center, medical director of the Christ Hospital Research Institute and professor of clinical medicine at The Ohio State University, said in a press release. “This type of patient is often turned down for catheter-based therapies.”
The patient was enrolled in the APOLLO pivotal trial of the TMVR system (Intrepid, Medtronic). He had a mitral annular calcification score of 10, a calcium volume score of 7,756 cm3, mitral valve area of 1.5 cm3, mitral regurgitation of 3+ and medically refractory symptoms of HF, the researchers wrote.
The researchers decided to perform IVL before mitral valve replacement because of the heavy calcification. They advanced two 8 x 60 mm IVL balloons (Shockwave M5+ IVL catheter, Shockwave Medical) across the mitral valve annulus, and performed lithotripsy after inflating both balloons to 4 atm. After that, they performed transseptal implantation of a 48 mm replacement valve. During the procedure, the operators used a cerebral embolic protection device (Sentinel cerebral protection system, Boston Scientific) to prevent systemic embolization.
The patient was discharged 3 days after the procedure.
On echocardiography at hospital discharge and at 30 days, the patient had mild (1+) mitral regurgitation, a mean gradient of 4 mm Hg and progressive circularization of the valve frame, the researchers wrote.
On CT, researchers noticed that between predischarge and 30 days, there was expansion of the valve frame in the anteroposterior dimension (predischarge, 21.9 mm; 30 days, 22.4 mm), including expansion of the ventricular edge of the frame from 23.2 mm to 24.6 mm and expansion of the inflow edge of the frame from 19.5 mm to 21.8 mm.
“Although anecdotal, this case will hopefully prompt a larger-scale investigation of IVL-facilitated TMVR in severe mitral annular calcification/mitral valve leaflet calcification and pan-cerebral embolic protection,” Kereiakes and colleagues wrote. “Further clinical research is required before IVL can be a routine adjunct to TMVR.”
The Intrepid device is not yet approved for commercial use in the United States.
Reference:
- Society for Cardiovascular Angiography and Interventions. www.eurekalert.org/news-releases/976009. Published Jan. 10, 2023. Accessed Jan. 10, 2023.
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