Focused Ultrasound Therapy
Focused ultrasound is an early-stage, non-invasive, therapeutic technology with the potential to improve the quality of life and decrease the cost of care for patients with calcifications on their heart valves. This novel technology focuses beams of ultrasonic energy precisely and accurately on targets deep in the body without damaging surrounding normal tissue. Where the beams converge, the ultrasound produces a variety of therapeutic effects enabling calcified deposits on the valves to be treated.
This approach uses pulsed cavitational focused ultrasound, also known as histotripsy, which delivers high intensity ultrasound to the target where it alters the structure of the calcium deposits on the valve, which improves the valves ability to open and improves blood flow. This is similar to lithotripsy, which is used on kidney stones. The mechanism for histotripsy is that tiny microbubbles form and impact the target tissue resulting in fragmentation of the calcium deposits, which enables better valve opening. This work is still at an early stage, and more research is needed before it can progress to clinical trials.
The primary option for treatment of calcification of the heart valves is surgery. For certain patients, focused ultrasound could provide a non-invasive alternative to surgery with less risk of complications and lower cost.
A new startup company is raising funds to pursue treatment of patients with aortic stenosis that have calcifications on their aortic valves. In preparation for this venture, the company is seeking to compile cardiogenic loops of patients with aortic stenosis, to validate their valve tracking capability. For more information about this, please click here.
- Focused ultrasound is a noninvasive approach, without surgical risks of infections or healing
- Focused ultrasound treatment improves both the calcification and the flexibility of the patients valve
- There are no issues related to the mechanical replacements or requirements for anticoagulants
At the present time, there are no clinical trials recruiting patients for focused ultrasound treatment of heart valve calcifications.
Regulatory Approval and Reimbursement
Focused ultrasound treatment for heart valve calcifications is not yet approved by regulatory bodies or covered by medical insurance companies.
Olivier Villemain, MD, Justine Robin, MS, Alain Bel, MD, Wojciech Kwiecinski, PhD, Patrick Bruneval,MD, Bastien Arnal, PhD, Mathieu Rémond, PhD, Mickael Tanter, PhD, Emmanuel Messas, MD, PhD, Mathieu Pernot, PhD. Pulsed Cavitational Ultrasound Softening : A New Noninvasive Therapeutic Approach for Calcified Bioprosthetic Valve Stenosis
Petrusca L, Salomir R, Milleret R, Pichot O, Rata M, Cotton F, Chapelon JY. Experimental investigation of thermal effects in HIFU-based external valvuloplasty with a non-spherical transducer, using high-resolution MR thermometry. Phys Med Biol. 2009 Sep 7;54(17):5123-38. doi: 10.1088/0031-9155/54/17/004. Epub 2009 Aug 6.
Click here for additional references from PubMed.