The AMPLATZER™ Amulet™ – facing the challenge of left atrial appendage occlusion
Over the last decade left atrial appendage occlusion has been a topic of intense clinical research
The first device in trial was the PLAATO percutaneous left atrial appendage transcatheter occlusion system; the PLAATO registry was led by Horst Sievert. Unfortunately, the device was quite complex and the regulatory demand for a randomised trial was expensive which resulted in its disappearance from the landscape of interventional devices. The WATCHMAN device also had a complex regulatory assessment but was eventually approved by the FDA.
This registry on the AMPLATZER™ Amulet™ is another major step forward in the field. It is an observational study, conducted in the real world with well-documented periprocedural transoesophageal echocardiography and a short-term clinical follow-up.
The device implantation success rate is impressive at 99%, and the rate of major adverse events in hospital is low (in the range of 3%). The study comprises a cohort of more than 1,000 patients with a CHA2DS2-VASc score of 4.2 and a HAS-BLED score of 3.3; 82.8% of the patients had a contraindication to anticoagulation and 72.4% had previous major bleeding. The vast majority of patients left hospital with single or dual antiplatelet therapy and only 18.9% on oral anticoagulation.
The interesting point of the observation is the transoesophageal echo at around two to three months, showing adequate occlusion of the appendage in 90.82% of the patients with only 1.5% device thrombosis.
I highly recommend to read the message of this important document - an interesting study led by many European investigators with knowledge of the AMPLATZER Amulet device.
Patrick W. Serruys, Editor-in-Chief, EuroIntervention