Transfemoral Transcatheter Tricuspid Valve Replacement With the EVOQUE System A Multicenter, Observational, First-in-Human Experience

Fam, Neil P.; Bardeleben, Ralph Stephan von; Hensey, Mark; Kodali, Susheel K.; Smith, Robert L.; Hausleiter, Joerg; Ong, Geraldine; Boone, Robert; Ruf, Tobias; George, Isaac; Szerlip, Molly; Naebauer, Michael; Ali, Faeez M.; Moss, Robert; Bapat, Vinayak; Schnitzler, Katharina; Kreidel, Felix; Ye, Jian; Deva, Djeven P.; Mack, Michael J.; Grayburn, Paul A.; Peterson, Mark D.; Leon, Martin B.; Hahn, Rebecca T. und Webb, John G. (2021): Transfemoral Transcatheter Tricuspid Valve Replacement With the EVOQUE System A Multicenter, Observational, First-in-Human Experience. In: Jacc-Cardiovascular Interventions, Bd. 14, Nr. 5: S. 501-511

Abstract

OBJECTIVES The purpose of this observational first-in-human experience was to investigate the feasibility and safety of the EVOQUE tricuspid valve replacement system and its impact on short-term clinical outcomes. BACKGROUND Transcatheter tricuspid intervention is a promising option for selected patients with severe tricuspid regurgitation (TR). Although transcatheter leaflet repair is an option for some, transcatheter tricuspid valve replacement (TTVR) may be applicable to a broader population. METHODS Twenty-five patients with severe TR underwent EVOQUE TTVR in a compassionate-use experience. The primary outcome was technical success, with NYHA (NYHA) functional class, TR grade, and major adverse cardiac and cerebrovascular events assessed at 30-day follow-up. RESULTS All patients (mean age 76 +/- 3 years, 88% women) were at high surgical risk (mean Society of Thoracic Surgeons risk score 9.1 +/- 2.3%), with 96% in NYHA functional class III or IV. TR etiology was predominantly functional, with mean tricuspid annular diameter of 44.8 +/- 7.8 mm and mean tricuspid annular plane systolic excursion of 16 +/- 2 mm. Technical success was 92%, with no intraprocedural mortality or conversion to surgery. At 30-day follow-up, mortality was 0%, 76% of patients were in NYHA functional class I or II, and TR grade was #2 & thorn;in 96%. Major bleeding occurred in 3 patients (12%), 2 patients (8%) required pacemaker implantation, and 1 patient (4%) required dialysis. CONCLUSIONS This first-in-human experience evaluating EVOQUE TTVR demonstrated high technical success, acceptable safety, and significant clinical improvement. Larger prospective studies are needed to confirm durability and safety and the impact on long-term clinical outcomes.& nbsp;

• Dokumententyp: Zeitschriftenartikel
• Fakultät: Medizin
• Themengebiete: 600 Technik, Medizin, angewandte Wissenschaften > 610 Medizin und Gesundheit
• ISSN: 1936-8798
• Sprache: Englisch