학술논문
Abstract 12626: Valvosoft Non-Invasive Ultrasound Therapy (NIUT) in Patients With Severe Symptomatic Aortic Valve Stenosis: First-in-Human Study - Twelve-Months Safety Update
Document Type
Article
Author
Messas, Emmanuel; Goudot, Guillaume; Ijsselmuiden, Alexander; den Heijer, Peter; Trifunovic, Danijela; Olga, Petrovic; Puymirat, Etienne; CHOLLEY, Bernard; Spaulding, Christian; Marijon, Eloi; van Gameren, Menno; Velinovic, Milos; Kovacevic-Kostic, Natasa; Terzic, Dusko; Milicevic, Vladimir; Karan, Radmila; Rémond, Mathieu; Penot, Robin; Pernot, Mathieu; Tanter, Mickael; BERTRAND, Benjamin; Spaargaren, Rene
Source
Circulation (Ovid); November 2021, Vol. 144 Issue: Supplement 1 pA12626-A12626, 1p
Subject
Language
ISSN
00097322; 15244539
Abstract
Background:While aortic valve replacements (AVR) generally present favorable outcomes in severe calcific aortic stenosis (CAS), not all patients are eligible for an invasive treatment.Cardiawave©developed a novel non-invasive ultrasound therapy (NIUT) device, Valvosoft, to treat CAS. A prospective first-in-human study was conducted in two centers (Hôpital Européen Georges-Pompidou, France and Heart Center, Amphia Hospital, Netherlands) in 10 patients and a second study (University Clinical Center of Serbia) involving brain-MRI in 4 patients. All patients had symptomatic severe CAS and were ineligible for SAVR or TAVR according to local heart teams.Methods:Transthoracic NIUT was delivered on all 14 patients with Valvosoft. Clinical and echocardiographic evaluation was performed at baseline, discharge, 1-, 3-, 6- and 12-months follow-up (FUP). Additionally, the 4 patients of the second study had a brain-MRI performed before and after treatment.Results:Patients were advanced in age (82.4±5.3 years) with severe comorbidities (57% with heart failure and 50% with coronary heart disease). No adverse events (AE) occurred during the procedure other than isolated ventricular extrasystoles. No serious AE were adjudicated by a Clinical Event Committee (CEC) as device- or procedure-related at 1-month FUP. No death, stroke or transient ischemic attack or deterioration of neurological status were observed at 1-month FUP.During 12-months FUP, 5 deaths were reported (between 2 to 7 months after the procedure), all were adjudicated by CEC as non-procedure related. The survival rate was 100%, 93%, 79%, 64% at 1-, 3-, 6 and 12-months (to compare to the classic natural evolution of the disease survival rate of 94%, 73%, 73%, 54% respectively). No sign of cerebrovascular accident was detected in any of the 4 patients who had a brain-MRI before and after treatment.Conclusions:NIUT was feasible and safe in this small cohort of very frail, severe symptomatic CAS patients with severe comorbidities. Brain-MRIs performed before and after treatment ruled out silent cerebrovascular events. The survival rate of this cohort suggests that NIUT is beneficial for these patients and serves an unmet medical need.