Prof. Emmanuel Messas and his team achieved a world first at the Georges Pompidou European Hospital in Paris by using ultrasound to treat patients with very severe calcified aortic stenosis (CAS), for whom no other treatment options were available.
1| A non-invasive treatment for CAS, a world first
Around 16% of patients with very severe calcified aortic stenosis (CAS) are not suitable for other treatments, such as open heart surgery or TAVI (Transcatheter Aortic Valve Implantation), in which a bioprosthetic valve replacement is performed percutaneously.1
For these patients, non-invasive ultrasound therapy will soon be a potential option, based on a medical technology developed by Professor Emmanuel Messas, a cardiologist at the Georges Pompidou European Hospital in Paris.
This non-invasive method targets the calcified aortic valve leaflets with a very high-intensity ultrasound beam that acts locally on the calcification.
The treatment softens the aortic valve leaflet tissue and thus reduces the stenosis.
This is a world first for calcified aortic stenosis patients not eligible for either TAVI or surgery due to comorbidities or vascular access difficulties.
2| The results were presented at the most recent American Heart Association scientific congress
The study included 10 patients, 5 at the Georges Pompidou European Hospital and 5 at Amphia Hospital in the Netherlands. The average age of the patients was 84 years.2
The study results were presented at the TCT (Transcatheter Cardiovascular Therapeutics) meeting in September 2019 in San Francisco, and at the American Heart Association scientific congress by Prof. Messas.
The results are very encouraging for patients with severe aortic valve stenosis.
The researchers demonstrated that, 3 months after the procedure, the technique used had not led to any serious adverse effects. Conversely, numerous benefits were observed, such as a clinical improvement according to NYHA (New York Heart Association) heart failure classification criteria for 7 out of 10 patients.
Valve surface improvements as a result of microfragmentation were observed for 8 of them and, for 6 patients, hemodynamic improvements were confirmed.
The researchers believe that additional studies with a longer follow-up and a larger sample of patients are required in order to confirm the value of this new non-invasive method for the treatment of CAS.3
- Annual number of candidates for Transcatheter aortic valve implantation per country: current estimates and future projections. Andras P. Durko, Ruben L. Osnabrugge, Nicolas M. Van Mieghem, Milan Milojevic, Darren Mylotte, Vuyisile T. Nkomo, and A. Pieter Kappetein. European Heart Journal (2018) 39. 2635-2642. doi:10.1093/eurheartj/ehy107.
- Villemain O, Robin J, Bel A, Kwiecinski W, Bruneval P, Arnal B, Rémond M, Tanter M, Messas E, Pernot M, Pulsed Cavitational Ultrasound Softening: a new non-invasive therapeutic approach of calcified bioprosthetic valve stenosis, JACC Basic Transl Sci. 2017 Aug;2(4):372-383. doi: 10.1016/j.jacbts.2017.03.012.
- Results of the study presented by Prof. Messas, on November 16, 2019 at the Early Science Session: “Prospective, Single-Arm Clinical Investigation for the Non-Invasive Transthoracic Treatment of Subjects With Severe Symptomatic Aortic Valve Stenosis Using Valvosoft® Pulsed Cavitational Ultrasound Therapy (PCUT) - First-in-Man.