Percutaneous Left Atrial Appendage Transcatheter Occlusion (PLAATO) Therapy could significantly reduce the rate of stroke in non-rheumatic atrial fibrillation (NRAF) patients by more than 50%.
PLAATO Therapy involves the placement of a permanent implant into the left atrial appendage (LAA) in a single, percutaneous procedure performed in the cardiac catheterisation laboratory under fluoroscopic and echocardiographic guidance. The procedure can be done under light sedation or general anaesthesia, and takes about one hour. The implant consists of a self-expanding frame constructed from Nitinol and a non-thrombogenic occlusion membrane of expanded polytetrafluoroethylene (ePTFE).
The European and US feasibility studies, which enrolled 111 NRAF patients at moderate to high risk of stroke who were unable to take anticoagulation therapy, have demonstrated that the PLAATO Therapy effectively and safely occludes the LAA.
Professor Horst Sievert, who performed the first PLAATO case in August 2001, told Cardiovascular News the latest clinical studies showed the stroke rate was 60 % lower after PLAATO Therapy compared to a historical control group without PLAATO.
"However, the trial was not designed to test this, it was a feasibility trial. But these preliminary results show that we are on the right way," Sievert said.
He added that complications during the procedure are very rare. "During FU we did not have any clinically relevant complication," he said. Sievert said a patient with atrial fibrillation (AF) who cannot or will not take anticoagulation treatment is highly eligible for PLAATO Therapy. "The most common side effect of anticoagulation therapy is gastrointestinal bleeding," he said.
"So many patients are referred to PLAATO Therapy from those physicians in intensive care or gastroenterologists. Patients are also referred by neurologists if anticoagulation was not sufficient to prevent cerebral embolic events."
Sievert said the chief advantage of AF patients with moderate to high risk of stroke having PLAATO Therapy is that they do not have to take anticoagulation treatment - such as warfarin, coumadin - which can cause many side effects such as the aforementioned bleeding. The treatment was difficult to manage in clinical practice as there was frequent blood control and dietary requirement issues.
Sievert said implantation of the PLAATO device is performed in a cardiology catheterisation lab. Following the procedure, patients are asked to stay in the hospital overnight for observation. Long term, patients remain on ASA indefinitely and may also receive clopidogrel for three to six months at the discretion of the physician.
As of January 2005, there have been over 350 patients treated with PLAATO Therapy in 40 centres worldwide. The PLAATO device received CE mark in May 2002 and is manufactured by ev3 Inc.
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