"Physicians have used the snarelike LARIAT device to close off a sac in the heart that is thought to be the source of harmful clots. But a new University of Pennsylvanialed study finds that this procedure is risky.   In older patients with atrial fibrillation cardiologists increasingly are using a snarelike device to close off a small sac in the heart thought to be the source of clots that can cause stroke in those with the abnormal heart rhythm. But the U.S. Food and Drug Administration did not approve the Lariat device for that specific purpose and now a new University of Pennsylvanialed study says this approach though legal too often leads to urgent surgery and even death. Several area hospitals have used the device including one that is part of Penns own health system  Pennsylvania Hospital  though physicians there have stopped. Others that have tried it include Deborah Heart  Lung Center in Browns Mills and Cooper University Health Care in Camden where physicians say it is a reasonable choice for strokeprone patients with limited options. In the study published Monday in JAMA Internal Medicine authors found that the procedure was reported to be successful in . percent of the  cases they identified in the medical literature. Success meant physicians were able to close off the left atrial appendage a sac in the wall of the hearts left atrium  not that there was any reduction in the rate of strokes. But urgent followup surgery was needed in seven patients or . percent of reported cases and one patient died. The study authors also searched an FDA database of adverse events associated with medical devices finding reports of five patients who died after undergoing a Lariat heart procedure and an additional  who required urgent followup surgery. Senior author Jay Giri an assistant professor at Penns Perelman School of Medicine urged a formal study of the device before further use. The Lariat is an absolutely ingenious piece of engineering said Giri an interventional cardiologist. However ingenuity doesnt guarantee its safety and efficacy. Meanwhile the device made by SentreHEART Inc. of Redwood City Calif. is facing competition from a product specifically approved by the FDA to deal with this heart sac. Rather than cinching the sac shut the Watchman device is implanted in the sac to block clots from emerging. The Watchman made by Boston Scientific of Marlborough Mass. was cleared by the FDA in March after rigorous clinical trials. The FDA approved the Lariat in  without such trials because its manufacturer told the agency that the product was substantially equivalent to other suturing devices on the market. But those other devices are not used to close off the left atrial appendage and SentreHEART is not allowed to promote the Lariat for that specific purpose either. In fact on the companys website description of the Lariat the only time the word heart appears is in the companys name. The company has filed for a patent to use the device for closing off the heart sac. Giri the study senior author said those facts have left little question that Lariat was designed with the heart in mind even though it was not specifically approved for that purpose. He referred to the process through which it was approved as a regulatory loophole. In a statement the company said that it agreed with the study authors that more research was warranted and that it was in the process of discussing clinical trials with the FDA. However it did not answer questions about whether the Lariat had been used for anything other than cardiac procedures. The way in which the FDA can approve devices as substantially equivalent to those already on the market called the k process has come under fire with other devices recently. Among them are duodenoscopes that have undergone numerous incremental changes and now are thought to pose a higher risk of transmitting bacteria. Physicians who use the Lariat to close off the left atrial appendage are said to be using the product offlabel a practice that is legal and can lead to innovation. It is unclear just how many times the Lariat has been used to close off the heart sac as it is designated with a general billing code that can refer to closing off the appendage with any of several techniques. In Pennsylvania cardiologists closed off a left atrial appendage  times between Sept.   and Aug.   according to the Pennsylvania Health Care Cost Containment Council a state agency that tracks healthcare cost and quality. At Cooper cardiologist Phillip Koren said he and colleagues have used the Lariat on the left atrial appendage of about  patients in the last six months. The closure was unsuccessful in a few of those cases but in those there have been no strokes said Koren deputy director of the Cooper Heart Institute. None of the  patients suffered adverse events from the device. In patients with afib whose hearts pump blood less efficiently the appendage is thought to be a source of clots because blood can stagnate there. When such clots travel toward the brain that means stroke. Closing off the appendage with the Lariat delivered through catheters not an open incision involves placing magnets inside and outside the heart to serve as a guide for inserting the snare Koren said. It takes two hours and is performed after putting the patient under general anesthesia. At Cooper Koren said the procedure was recommended only in patients who were at high risk of stroke and who had difficulty with anticoagulant medication the usual course of treatment for preventing clots. He said Cooper also planned to start using the Watchman which he said might be easier to use. We are extremely excited that were on the cutting edge of new treatments for patients with atrial fibrillation Koren said. We always have to weigh the benefits and the risks. One of the authors of the new study Daniel McCormick of Pennsylvania Hospital also expressed enthusiasm when he first used the Lariat in January . Its terrific to be able to add another tool to our arsenal of treatments for atrial fibrillation McCormick said in a hospital blog post then. Titled Lasso It Up How a Rodeo Roping Technique Can Help Treat an Ageold Heart Ailment the post was illustrated with a drawing of a ropewielding cowboy on horseback. McCormick was not available to discuss his apparently changed opinion of the procedure but he and study coauthors concluded with the following Highquality randomized clinical trials examining the Lariat as a device for LAA exclusion should be obtained before its widespread use is adopted by the medical community."