Safety and Efficacy of Pivot-Balloon for Severe Tricuspid Regurgitation: The First-in-Man Experiences
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Le résumé fourni par la source
BACKGROUND AND OBJECTIVES: Among various emerging catheter-based treatments for severe tricuspid regurgitation (TR), the spacer device can reduce the regurgitation orifice without manipulating the valve leaflet. However, its clinical application has been hampered by traumatic anchoring to the myocardium and the coaxial alignment of the balloon resulting in insufficient TR reduction. This study aimed to evaluate the early-stage safety, technical feasibility, and preliminary efficacy of the novel atraumatic vertical spacer in patients with isolated severe TR. METHODS: All procedures were guided by fluoroscopy and transthoracic echocardiography. The maximum device placement time with an inflated balloon was 24 hours. Changes in the amount of TR, right ventricular function, and patient hemodynamics were measured during balloon deployment. RESULTS: A total of 7 patients (median age 74), underwent successful device implantation without procedure-related complications. During balloon inflation (median 25 minutes), there were no symptoms or signs indicative of TR intolerance. TR was reduced by 1 grade or greater in all patients, with 2 patients exhibiting a reduction of 3 grades, from torrential TR to a moderate degree. Mild TR after balloon inflation was achieved in 3 patients with baseline severe TR. The TR reduction observed during initial balloon deployment was sustained during the subsequent balloon maintenance period. CONCLUSIONS: The Pivot-balloon procedure was safe, technically feasible, and effective in reducing TR in patients with severe TR. No periprocedural complications or adverse cardiovascular events were reported during device placement with TR reduction observed in all patients. However, longer-term follow-up is needed to confirm safety and treatment effect. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT05648838.
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Le contrôle bibliographique ouvert
DOI retrouvé dans Crossref DOI retrouvé ; titre concordant.
- Titre Crossref
- Safety and Efficacy of Pivot-Balloon for Severe Tricuspid Regurgitation: The First-in-Man Experiences
- Date Crossref
- 01/01/2025
- Éditeur
- XMLink
- Type
- journal-article
Ce recoupement confirme des métadonnées liées au DOI. Il ne confirme ni la méthode ni les conclusions de l’étude, et il ne compte pas comme une seconde source scientifique indépendante.
Où se fait cette recherche
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Samsung Medical Center pays non établi dans la noticeÉtablissement de santé
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Pusan National University Yangsan Hospital pays non établi dans la noticeÉtablissement de santé
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Hallym University Sacred Heart Hospital Department of Internal Medicine pays non établi dans la noticeÉtablissement de santé
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Ulsan College Department of Cardiology pays non établi dans la noticeUniversité ou école supérieure
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Asan Medical Center pays non établi dans la noticeÉtablissement de santé
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University of Ulsan pays non établi dans la noticeUniversité ou école supérieure
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Chungnam National University Hospital Department of Cardiology in Internal Medicine pays non établi dans la noticeÉtablissement de santé
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Chungnam National University Department of Cardiology pays non établi dans la noticeUniversité ou école supérieure
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Chungnam National University Sejong Hospital pays non établi dans la noticeÉtablissement de santé
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Sejong General Hospital Department of Cardiology pays non établi dans la noticeÉtablissement de santé
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Ulsan University Hospital Department of Cardiology pays non établi dans la noticeÉtablissement de santé
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Keimyung University Dongsan Medical Center Division of Cardiology pays non établi dans la noticeÉtablissement de santé
Samsung Medical Center, Pusan National University Yangsan Hospital et Department of Internal Medicine — Hallym University Sacred Heart Hospital, avec 9 autres affiliations.
Une affiliation ne permet pas de déduire la nationalité d’un auteur.