| Autor: |
Neil P, Fam, Ralph Stephan, von Bardeleben, Mark, Hensey, Susheel K, Kodali, Robert L, Smith, Jörg, Hausleiter, Geraldine, Ong, Robert, Boone, Tobias, Ruf, Isaac, George, Molly, Szerlip, Michael, Näbauer, Faeez M, Ali, Robert, Moss, Vinayak, Bapat, Katharina, Schnitzler, Felix, Kreidel, Jian, Ye, Djeven P, Deva, Michael J, Mack, Paul A, Grayburn, Mark D, Peterson, Martin B, Leon, Rebecca T, Hahn, John G, Webb |
| Rok vydání: |
2020 |
| Předmět: |
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| Zdroj: |
JACC. Cardiovascular interventions. 14(5) |
| ISSN: |
1876-7605 |
| Popis: |
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.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.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.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+ in 96%. Major bleeding occurred in 3 patients (12%), 2 patients (8%) required pacemaker implantation, and 1 patient (4%) required dialysis.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. |
| Databáze: |
OpenAIRE |
| Externí odkaz: |
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