That finding comes from a study published online in Circulation: Arrhythmia and Electrophysiology.
Juan Viles-Gonzalez, M.D., assistant professor of medicine in the Cardiovascular Division, and colleagues from a number of medical institutions examined data from the Nationwide Inpatient Sample on 268 percutaneous LAA closures performed for the prevention of stroke in patients (mean age of 70) with atrial fibrillation from 2006 to 2010. Researchers were unable to differentiate among the technologies deployed, which included the investigational Watchman device (Boston Scientific), the Amplatzer cardiac plug (St. Jude Medical), and the Lariat suture device (SentreHeart), because of the use of a single ICD-9 code for all procedures. They also found that closures performed at higher-volume centers come with shorter hospital stays and lower costs.
Other Miller School researchers involved in the study were James O. Coffey, M.D., assistant professor of medicine, Michael Hoosien, M.D., post-doctoral fellow in the Cardiovascular Division, cardiology fellow Vikas Singh, M.D., cardiology residents Peeyush Grover, M.D., and Ghanshyambhai T. Savani, M.D., and former cardiology fellow Apurva O. Bhadeka, M.D.
Much of the safety data on percutaneous LAA closure devices comes from clinical trials and might not reflect what happens in daily practice, the authors say. Even though the mortality rate in this study (2.3 percent) is lower than rates seen in previous research (the PROTECT AF trial of the Watchman device at 3.2 percent, and a recent observational study of the Amplatzer cardiac plug at 5.8 percent), the combined rate of mortality and complications is higher than reported in prior studies.
Viles-Gonzalez says this study included a more comprehensive and broader range of complications (including infections, deep vein thrombosis, pressure ulcer, and renal failure), which could explain this higher complication rate.
The finding that higher-volume hospitals had better outcomes, however, was concordant with results from PROTECT AF and the Continued Access Protocol registry.
Given the ever-increasing economic burden of health care spending in the U.S., Viles-Gonzalez says, “This finding suggests that perhaps percutaneous LAA closure, like other complex and highly technical procedures, should be performed only by centers and operators that can maintain an acceptable volume threshold.”
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