Boston Scientific’s Watchman left atrial appendage (LAA) closure device has been implanted in the first patients in Latin America. The novel device is designed for use in patients with atrial fibrillation who are at risk for stroke and are eligible for long-term oral anticoagulation therapy such as warfarin.
The Watchman LAA closure device is intended to prevent embolization of thrombi that may form in the LAA, thereby preventing the occurrence of ischaemic stroke and systemic thromboembolism in patients with non-valvular atrial fibrillation. The first patient implants were performed by Bernardo Caicedo, interventional cardiologist, Angiografia de Occidente, Cali, Colombia.
Patients with atrial fibrillation are at greater risk for stroke due to the formation and migration of clots in the left atrial appendage. Anticoagulants such as warfarin have traditionally been the only therapy for reducing stroke risk in these patients. The Watchman device is intended to be an alternative to long-term anticoagulation. It is designed to close the left atrial appendage, thereby preventing clots within the appendage from being dislodged into the bloodstream.
“I am excited to be part of the first patient implants of the Watchman device in Latin America,” said Caicedo. “The percutaneously delivered device promises to offer a safe and effective alternative for atrial fibrillation patients who cannot take long-term oral anticoagulants and have limited options to reduce their stroke risk. It incorporates a pre-loaded device that is both repositionable and retrievable to enhance its ease of use.”
The Watchman device is the most clinically studied product of its kind currently available. In the multicentre, randomised PROTECT AF clinical trial, it proved to be non-inferior to warfarin and demonstrated a 38% relative risk reduction for a combined measure of stroke, cardiovascular death and systemic embolism compared to long-term warfarin therapy in 800 patients. The study also showed a 29% relative risk reduction in all stroke and a 90% relative risk reduction in haemorrhagic stroke compared to warfarin. Nearly 1,800 patients have now been recruited in Watchman clinical trials with more than 2,700 patient-years of follow-up. The Watchman device is CE marked and was commercialised outside the United States in 2009.
Boston Scientific is currently enrolling US patients in the PREVAIL study, a confirmatory study designed to gain Food and Drug Administration approval. Enrolment is expected to be completed in the first quarter of 2012. In the USA, the Watchman device is an investigational device, limited by applicable law to investigational use and not available for sale. The device was developed by Atritech, which Boston Scientific acquired in March 2011.