Initial results evaluating the feasibility, safety and efficacy of the Ultraseal device for left atrial appendage closure (LAAC) in patients with nonvalvular atrial fibrillation (AFib) at high bleeding risk showed a high implant success rate and a low incidence of procedure-related complications. The results, presented by Lluis Asmarats, MD, et al., at TCT 2018 and published in JACC: Interventions, also found a low rate of ischemic stroke at midterm follow-up.

The study included 126 patients (mean age75±8 year) undergoing LAAC with the Ultraseal device at 15 European and Canadian sites. The device was successfully implanted in 97 percent of patients, with a major periprocedural adverse event only reported in three patients (2.4 percent).

Researchers noted that 90 percent of patients were discharged on single or dual antiplatelet therapy. Follow-up TEE in 73 percent of patients showed no cases of large (>5 mm) residual leak and five cases of device-related thrombosis. At a median follow-up of six months, the rates of stroke and transient ischemic attack were both 0.8 percent, with no systemic emboli. None of the events occurred in patients with device-related thrombosis.

Asmarats and colleagues said larger studies are further warranted to confirm the long-term safety and efficacy of the new device. Meanwhile, in a related editorial, Kimberly Atianzar, MD, and Sameer A. Gafoor, MD, FACC, question the need for "yet another" LAAO device. "Aside from the benefit of increased competition in the marketplace pushing for decreased prices and decreased cost to the payer, there is benefit in advanced iteration," they write. "… Is this device the final device in left atrial appendage occlusion? No. Does it appear to be reasonably safe and effective? Yes, in appropriate programs when devices were placed by appropriate operators. Nevertheless, that is the case for every intra-cardiac device."

Keywords: TCT18, Transcatheter Cardiovascular Therapeutics

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