Appeal type: Experimental/Investigational
Decision: Upheld

Physician 1: This patient is a 57-year-old male who has known ischemic cardiomyopathy and is at risk for a stroke with paroxysmal atrial fibrillation. He has several comorbid conditions and standard treatment with Coumadin is thought to be risky because of unexplained GI bleeding. The patients provider has recommended the patient undergo implantation of a left atrial appendage occluder device known as PLAATO. The Health Plan has denied the request on the basis the requested device is considered investigational.Implantation of the PLAATO device is a very new technique that is currently under study to help prevent strokes in certain patients. It was only first described in the canine model in 2002 and hence, there is no real long-term data available. The largest study of PLAATO published thus far involved 111 patients (Ostermayer, et al.). It was concluded that PLAATO is feasible and can be performed at acceptable risk. The authors concluded, `long-term studies are needed to confirm long-term safety of the device and a redirection in thromboembolic events. The authors further indicated a larger randomized trial is in the planning stage, which will allow for assessment of the efficacy of the PLAATO device. Until a large randomized trial is published (as suggested above) it is unknown if PLAATO will be beneficial (or harmful) in the long-term in this high-risk group of patients. The Ostermayer study shows feasibility and suggests a 50% short-term benefit, but it is not powered or designed as applicable to the general high-risk population. Further work and research on PLAATO will continue, but currently its application would be within the context of a clinical trial rather than general clinical use.Based upon the information set forth above, I have determined that the requested device is not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Plans denial should be upheld.Physician 2: The patient is a 57-year-old male who has a complex history of heart disease, atrial fibrillation, severe ischemic cardiomyopathy, congestive heart failure, coronary artery disease, and hypertension. The enrollee has requested authorization and coverage for implantation of a left atrial appendage occluder (PLAATO) device. The Health Plan has denied the request indicating the long-term efficacy of the requested device has not been established.Implantation of a PLAATO device is considered an option for prevention of embolic stroke in individuals who have a contraindication to anticoagulation therapy. The PLAATO device has not been approved by the Food and Drug Administration and is under investigational trial in Europe. The procedure is not currently available in the United States.Standard therapy options are: surgical amputation of the left atrial appendage, aspirin therapy or no treatment. It has not yet been demonstrated that the requested device is superior to standard therapy. Based upon the information set forth above, I have determined that the requested therapy is not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Plans denial should be upheld.Physician 3: The patient is a 57-year-old male with cardiomyopathy, ICD, and chronic afibrillation (refractory to amiodarone). In addition, the patient has recurrent gastrointestinal bleeding, the source of which is not clear but presumed to be arteriovenous malformation. The patient is being considered for implantation of a left atrial appendage occluder device known as PLAATO. The Health Plan indicates the requested device is considered investigational and therefore, has denied coverage for the device.Percutaneous left atrial appendage transcatheter occlusion is a procedure that is in its infancy. Feasibility trials have been conducted. However, there is a significant risk of life threatening complications from the procedure and it is not clear that the stroke rate following the procedure is any different from a control population (two strokes, and three transient ischemic attacks at only 9.8 months follow-up). Review of the relevant literature does not show that any controlled trials have been published. Nor is any long-term follow-up data available. At this time, the efficacy of the PLAATO device remains unproven and therefore, it cannot be recommended for this patient.Based upon the information set forth above, I have determined that the requested device is not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Plans denial should be upheld.