The EVOQUE device is designed with an intra-annular sealing system that provides excellent anatomical compatibility and an adaptable shape. It is currently available in four sizes (44 mm, 48 mm, 52 mm, and 56 mm) and is implanted using a 28-Fr transfemoral access.
The TRISCEND II study aimed to assess the efficacy and safety of the EVOQUE system compared to optimal medical therapy (OMT). It included patients with severe tricuspid regurgitation (TR) who experienced heart failure symptoms and were already under OMT at the time of inclusion. Patients with a life expectancy of less than 12 months, ejection fraction <25%, severe right ventricular dysfunction, or severe pulmonary hypertension were excluded from the trial.
A total of 400 patients were randomized 2:1 to either transcatheter tricuspid valve replacement (TTVR) with the EVOQUE device or OMT alone. The average participant age was 79.3 years, and 74.9% of subjects were women. Most patients (73%) experienced dyspnea classified as NYHA functional class III or IV, while 96% had atrial fibrillation, and 36% had an implantable pacemaker or cardioverter-defibrillator (ICD).
Successful implantation of the EVOQUE device was achieved in 95.4% of patients, with an average hospital stay of three days. Cardiovascular mortality was higher in the OMT group (7.8% vs. 5.7%). Clinical benefit was measured using the win probability ratio, which was 2.02 in favor of TTVR, thus indicating that patients treated with the EVOQUE device had nearly double the likelihood of clinical improvement compared to the control group.
From a hemodynamic perspective, TTVR with the EVOQUE system significantly reduced TR to mild or less in almost all patients. This reduction led to a significant improvement in symptoms, better functionality, and improved quality of life after one year of follow-up.
Presented by Raj Makkar at Top Late-Breaking Trials, PCR London Valves, November 24, 2024, London, Great Britain.
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