Intravascular Lithotripsy (IVL) for Mitral Valve Disease – Summary
Intravascular Lithotripsy (IVL) for Mitral Valve Disease – Summary
Published: August 13, 2025 | Medical News Highlights – Structural Interventions Section
Context on Valve Regurgitation Treatments
In transcatheter valve therapy, approaches differ by valve type:
* Aortic Valve (AV): Treated with TAVR, which fully replaces the valve.
* Mitral Valve (MV): Commonly treated with TEER (Transcatheter Edge-to-Edge Repair), using devices like MitraClip to reduce regurgitation by approximating leaflets.
* Tricuspid Valve (TV): Most often treated with TEER using devices like TriClip. Transcatheter tricuspid valve replacement (TTVR) is technically feasible but remains experimental, reserved for selected cases in advanced centers only.
* TMVR: A full catheter-based replacement of the mitral valve—currently limited to clinical trials and select patients, especially when severe Mitral Annular Calcification (MAC) poses technical challenges.
1. Background
• IVL has shown effectiveness in fracturing thin arterial calcium during revascularization.
• Researchers explored its potential to break dense calcification in MAC—a significant barrier to structural heart interventions.
• This concept saw a real-world application in a JSCAI–published case (within the APOLLO trial), where IVL was used in a patient with severe MAC undergoing TMVR using Medtronic’s Intrepid valve.
• The Intrepid valve is a self-expanding transcatheter mitral replacement system developed by Medtronic, designed to fully replace diseased mitral valves without open-heart surgery.
• A cerebral protection device was also used during the procedure to reduce the risk of calcium emboli causing stroke—highlighting safety considerations in complex cases.
2. Study
• A cadaver experiment used multiple Shockwave Medical IVL balloons in a heavily calcified mitral annulus.
• Delivered 600 low-pressure pulses to avoid damage.
• Imaging revealed some calcium fracture lines, but the impact was too minimal for practical clinical value.
3. Challenges
• Arterial calcium is thin (~eggshell), whereas valve calcium can be centimeters thick.
• Existing IVL balloons (up to 7 mm) are significantly smaller than the mitral orifice (30–35 mm).
• Standard balloon valvuloplasty may cause leaflet tearing and severe regurgitation.
• Both TMVR and TEER have limited applicability in cases with heavy calcification.
4. Next Steps
• Innovate larger, high-energy balloons with integrated perfusion to allow longer treatment without blocking blood flow.
• IVL has potential as a preparatory tool for TMVR or to soften MV leaflets for TEER.
5. Conclusion and Clinical Context
• The proof-of-concept shows IVL can fracture thick valve calcium, but current devices are inadequate for clinical use—further technological advances are required.
• APOLLO trial context: Early data show TMVR with Medtronic’s Intrepid valve can be performed successfully in highly selected patients, achieving substantial MR reduction and improved symptoms. However, these were trial-based findings—routine TMVR is not yet endorsed in clinical practice. It remains reserved for clinical trials, compassionate use, and specialized centers, as the technology remains under development.
Why APOLLO is highlighted: It’s a rare real-world application connecting bench research on IVL with clinical structural intervention—showing how IVL may facilitate TMVR in severe MAC and bridge experimental methods to future patient treatments.
