Among patients who underwent left atrial appendage occlusion (LAAO) with the Amulet 360 device, complete LAA closure was observed in 96.3% of patients at one year with low rates of stroke and mortality, according to results from the VERITAS trial, presented at TCT 2026 and simultaneously published in JACC: Cardiovascular Interventions.

Dhanunjaya Lakkireddy, MD, FACC, et al., included 458 patients (age 74 ± 7.3 years, 38.4% female) with nonvalvular atrial fibrillation and increased thromboembolism risk who underwent LAAO with the Amulet 360 device.

Using transesophageal echocardiography, complete LAA closure was observed in 96.3% of patients (95% CI, 93.2%-98.2%) at one year post procedure. Clinically relevant device-related thrombosis occurred in 0.4% of patients.

All-cause mortality was seen in 3.9% of patients, cardiovascular mortality in 1.9%, major bleeding in 6.6%, ischemic stroke or systemic embolism in 1.8%, and pericardial effusion requiring intervention in 0.9%. There were no cases of device embolization.

“The low mortality observed in VERITAS, together with low rates of pericardial effusion, device embolization, stroke and major bleeding, provides further evidence of a favorable overall clinical profile with the next-generation Amulet 360 device in this pre-market setting,” note Lakkireddy and colleagues.

Another late-breaking clinical trial, TRAVEL III, found that transjugular transcatheter tricuspid valve replacement (TTVR) with the new LuX-Valve Plus system in addition to optimal medical therapy (OMT) was superior to OMT alone in reducing tricuspid regurgitation (TR).

Junbo Ge, MD, PhD, FACC, et al., randomized 126 patients with severe or greater TR, NYHA III to IV and of high surgical risk to TTVR with the LuX-Valve Plus system and OMT or OMT alone. The primary safety outcome was a composite of major adverse events at 30 days and the primary efficacy outcome was a composite of survival, freedom from heart failure rehospitalization, TR reduction greater than or equal to one grade and NYHA improvement greater than or equal to one class at six months.

At six-month follow up, the primary efficacy outcome was observed in 82.9% of patients in the TTVR plus OMT group vs. 4.8% of the OMT only group (rate difference 78.1% [95% CI, 67.5-88.8]; p<0.001).

Researchers note no incidences of myocardial infarction, stroke, access-site/vascular complication or device-related pulmonary embolism at six months and low rates of post-procedural pacemaker implantation at 30 days and six months.

“TRAVEL III provides the first randomized evidence supporting transjugular TTVR with the LuX-Valve Plus system for patients with severe TR at high surgical risk,” states Ge. “TTVR reduced TR in all patients, with less than or equal to moderate TR in 93% at six months.”


Keywords:
Transcatheter Cardiovascular Therapeutics, TCT26