التفاصيل البيبلوغرافية
| العنوان: |
Abstract 12626: Valvosoft Non-Invasive Ultrasound Therapy (NIUT) in Patients With Severe Symptomatic Aortic Valve Stenosis: First-in-Human Study - Twelve-Months Safety Update |
| المؤلفون: |
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 |
| المصدر: |
Circulation ; volume 144, issue Suppl_1 ; ISSN 0009-7322 1524-4539 |
| بيانات النشر: |
Ovid Technologies (Wolters Kluwer Health) |
| سنة النشر: |
2021 |
| الوصف: |
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 ... |
| نوع الوثيقة: |
article in journal/newspaper |
| اللغة: |
English |
| DOI: |
10.1161/circ.144.suppl_1.12626 |
| الإتاحة: |
https://doi.org/10.1161/circ.144.suppl_1.12626Test |
| رقم الانضمام: |
edsbas.3B5CEB1D |
| قاعدة البيانات: |
BASE |
