News | Embolic Protection Devices | January 11, 2023

Shockwave Intravascular Lithotripsy-assisted TMVR Shows Promise for Patients with Severe Stenosis and Regurgitation

Study reveals findings from first in-human procedure  

Dean Kereiakes, MD, MSCAI

Dean Kereiakes, MD, MSCAI


January 11, 2023 — In recent years, transcatheter mitral valve replacement (TMVR) treatment and technology has evolved, but procedure-related morbidity remains a concern. A new study published in the Journal of the Society for Cardiovascular Angiography & Interventions (JSCAI) shows promise for intravascular lithotripsy (IVL)-assisted TMVR to treat a severely calcified mitral valve in a patient with severe stenosis and mitral regurgitation (MR).  

MR affects an estimated 4 million people in the United States. Mitral valve leaflets become damaged or stretched and the valve may not close properly, which allows blood to flow backward, causing MR. Aortic stenosis, which is a narrowed aortic valve that decreases blood flow from the heart to the body, impacts as many as 300,000 people per year.  

An 83-year-old male had previously received transcatheter aortic valve replacement (TAVR) for aortic stenosis presented with medically refractory dyspnea. He was enrolled in the APOLLO trial of Intrepid valve TMVR. Transseptal implantation of a 48-mm Intrepid valve was facilitated by Shockwave IVL delivered via two (8.0 x 60-mm) M5 + balloons placed across the mitral annulus before implantation. Cerebral embolic protection during IVL and valve implant was provided by Sentinel device and left subclavian balloon occlusion, according to the researchers.  

“Our team used IVL to modify this severely calcified mitral annulus and valve leaflets to facilitate expansion of the Intrepid self-expanding valve,” stated Dean Kereiakes, MD, MSCAI, lead author of the study and 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. “This type of patient is often turned down for catheter-based therapies.” 

Post-dilation achieved valve frame expansion and reduced MR. Post-procedural 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.  

Researchers stated that further clinical research and studies will be 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.

For more information: www.scai.org

Related content:

Shockwave Medical Initiates All-Female Coronary IVL Study

Disrupt PAD III Trial Demonstrates Safety and Effectiveness of Intravascular Lithotripsy for Peripheral Artery Calcification

Transcatheter Cardiovascular Therapeutics (TCT) 2022 Conference Preview

Medtronic Intrepid Transcatheter Mitral Valve Successfully Uses Transfemoral Delivery

Late-Breaking Data from PROTECTED TAVR Trial Demonstrate Reduced Risk of Disabling Stroke, Low Complication Rate with SENTINEL Cerebral Protection System


Related Content

News | SCAI

May 7, 2024 — Medtronic announced the release of important clinical outcomes in two leading transcatheter valve ...

Home May 07, 2024
Home
News | SCAI

May 7, 2024 — Women and black patients were less frequently treated with minimally invasive therapy compared to men or ...

Home May 07, 2024
Home
News | SCAI

May 1, 2024 — The annual Society for Cardiovascular Angiography & Interventions (SCAI) kicks off its SCAI Scientific ...

Home May 01, 2024
Home
News | SCAI

June 1, 2023 — New insights from the TWILIGHT trial showed that ticagrelor monotherapy after three months of ticagrelor ...

Home June 01, 2023
Home
News | SCAI

May 24, 2023 — The largest interventional study focused on pulmonary embolisms highlighted importance of rapid removal ...

Home May 24, 2023
Home
Feature | SCAI | Christine Book

May 23, 2023 — The Society for Cardiovascular Angiography & Interventions (SCAI) welcomed its 46th President and 2023 ...

Home May 23, 2023
Home
News | SCAI

May 19, 2023 — Findings from a study examining the relationship between marijuana use and peripheral artery disease (PAD ...

Home May 19, 2023
Home
News | SCAI

February 7, 2023 — The Society for Cardiovascular Angiography & Interventions (SCAI) announced the second application ...

Home February 07, 2023
Home
News | SCAI

January 18, 2023 — the Society for Cardiovascular Angiography & Interventions (SCAI) announced four recipients of their ...

Home January 18, 2023
Home
News | SCAI

December 8, 2022 — The Society for Cardiovascular Angiography & Interventions (SCAI), a leading nonprofit medical ...

Home December 08, 2022
Home
Subscribe Now