Abstract 17142: Long Term Results of Non-Invasive Ultrasound Therapy (NIUT) in Severe Symptomatic Aortic Valve Stenosis - First-in-Man - Archive ouverte HAL Accéder directement au contenu
Article Dans Une Revue Circulation Année : 2020

Abstract 17142: Long Term Results of Non-Invasive Ultrasound Therapy (NIUT) in Severe Symptomatic Aortic Valve Stenosis - First-in-Man

Emmanuel Messas
  • Fonction : Auteur
Alexander Ijsselmuiden
  • Fonction : Auteur
Selina Vlieger
  • Fonction : Auteur
Peter den Heijer
  • Fonction : Auteur
Guillaume Goudot
  • Fonction : Auteur
Etienne Puymirat
  • Fonction : Auteur
Samuel Zarka
  • Fonction : Auteur
Bernard Cholley
  • Fonction : Auteur
Christian Spaulding
  • Fonction : Auteur
Albert Hagege
  • Fonction : Auteur
Eloi Marijon
  • Fonction : Auteur
Mickael Tanter
  • Fonction : Auteur
Benjamin Bertrand
  • Fonction : Auteur
Mathieu Remond
  • Fonction : Auteur
Rene Spaargaren
  • Fonction : Auteur

Résumé

Background: Not all patients with severe aortic valve stenosis are eligible for open-heart surgery or TAVR. CARDIAWAVE (Paris, France) has developed Valvosoft, a unique non-invasive ultrasound therapy device to treat aortic stenosis. The therapy aims to improve the opening of severely calcified aortic valves by cracking the calcium and reducing the stiffness in the aortic valve tissue by delivering transthoracically local shock waves on the valve leaflets. This study assesses the safety, feasibility and performance of this novel technique. Methods: This is a multi-center, prospective, first-in-man study designed to evaluate the safety and feasibility of the Valvosoft device. Ten patients with severe symptomatic calcific aortic stenosis and not eligible for SAVR/TAVR underwent a Valvosoft ultrasound therapy. Echocardiographic evaluation was performed by an independent core lab at baseline, discharge, and at 1, 3, 6 and 12 months along with clinical follow up. Results: Enrolled patients were advanced in age (84.1±6.5 yrs) with severe comorbidities (8 with heart failure, 5 with coronary heart disease and 5 with kidney failure). All had extensive aortic valve calcification with mean AVA of 0.61±0.17 cm2 and mean pressure gradient of 37.5±10.5 mmHg. At one-month follow-up, six patients had significantly improved their AVA with increase of 27.5% (p=0.03) and mean pressure gradient decrease of 23.2 % (p=0.025). These patients also received the highest dose and longest treatment duration. During one year follow up, 4 patients died due to progression of end stage heart failure not linked to the procedure and one patient had undergone a TAVR procedure. At 12 months, the five remaining patients has no device or procedure related major adverse events nor deterioration of neurological status. Echo, brain-MRI and clinical follow up will be presented. Conclusions: Non-invasive ultrasound therapy is feasible and safe in patients with severe aortic valve stenosis and can improve AVA and hemodynamic parameters. NIUT can be an important tool complementary to TAVI in treating patients with aortic valve stenosis.
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hal-04089095 , version 1 (04-05-2023)

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Emmanuel Messas, Alexander Ijsselmuiden, Selina Vlieger, Peter den Heijer, Guillaume Goudot, et al.. Abstract 17142: Long Term Results of Non-Invasive Ultrasound Therapy (NIUT) in Severe Symptomatic Aortic Valve Stenosis - First-in-Man. Circulation, 2020, 142 (Suppl_3), ⟨10.1161/circ.142.suppl_3.17142⟩. ⟨hal-04089095⟩
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