Cardiologists at Saint John’s Health Center are the first in the entire nation to perform an innovative nonsurgical procedure using sutures to tie off the left atrial appendage (LAA). LAA is the primary source of blood clots leading to stroke in patients with atrial fibrillation (AF). The most common heart rhythm disorder, AF causes the upper chambers of the heart to beat fast and erratically. If uncontrolled, the condition can have serious consequences, including stroke and early death. The first LARIAT procedure, which precludes the need for open-heart surgery, was performed by Shephal K. Doshi, MD, Director of Cardiac Electrophysiology and Pacing at Saint John’s. With the patient under general anesthesia, the physicians guided two catheters into the patient’s heart to seal the LAA with a pre-tied suture loop—similar to a lasso—with the new FDA-approved LARIAT® Suture Delivery Device. “The ‘lasso’ is a very attractive alternative to the possibility of a lifetime of blood thinners (warfarin and Coumadin®) that can have serious side effects, as well as to invasive open-heart surgery,” Dr. Doshi said. This nonsurgical lasso procedure could provide long-term protection against stroke in patients with AF who are unable to tolerate blood thinners. Dr. Doshi and the Saint John’s cardiology team placed the pre-tied suture loop on the outside of the LAA using a pericardial approach, similar to what is used in surgery, without having to spread the ribcage or cut through bone to access the LAA. Rather than a surgical procedure, the technique uses a needle to introduce catheters into the heart.
Approximately 6 million adults in the United States have been diagnosed with AF, and the condition accounts for more than 20 percent of stroke-related deaths. Individuals who do take blood thinners and other anticoagulants must rigorously manage the level of the drugs in their blood. For some, this management regime can mean monthly tests over the course of many years. By eliminating the need to take long-term medications, the LAA procedure can reduce the need for frequent medical visits.“This pioneering work has the potential to help redirect the field of cardiac rhythm disorders,” said Lou Lazatin, Chief Executive Officer of Saint John’s. “It immediately follows the groundbreaking work Dr. Doshi and Saint John’s completed in evaluating a new device that is another excellent alternative to blood thinners.” From February 2005 through June 2008, the Saint John’s team, led by Dr. Doshi, participated in a clinical trial evaluating the WATCHMAN® device in 59 centers in the United States and Europe. A polyester fabric-covered, expandable metal cage that resembles a parachute, the device is guided through a catheter that is inserted into a vein in the upper leg, and then threaded through the atrial chambers.
Once appropriately positioned, the WATCHMAN is released at the opening of the LAA, where it expands to cover the opening. The body then forms scar tissue over the device, permanently sealing off the pouch and blocking the formation and release of blood clots.The clinical trial enrolled 707 AF patients randomly assigned to long-term warfarin therapy or implantation of the WATCHMAN device with discontinuation of warfarin. Results of the trial, published in the August 15, 2009 issue of The Lancet, showed that the device group had a significant reduction in the combined rate of stroke, bleeding and cardiovascular death when compared to the warfarin group. At two years, the combined event rate was 5.9 percent in the device group in contrast to 8.3 percent in the warfarin group. In successfully treated patients, the safety event rate was also lower in the device group than in the warfarin group. Based on the results of this pivotal study, an FDA Advisory Panel recently recommended approval of the WATCHMAN device.
“Saint John’s enrolled 53 patients in the PROTECT AF study, and we remain one of a select group of centers that can implant this device now in patients who meet appropriate criteria,” said Dr. Doshi. “Since the conclusion of the clinical trial, we have successfully implanted another 50 devices. We are currently the worldwide leader in implant volume, and our safety record is outstanding.” Both the LARIAT procedure and implantation of the WATCHMAN device are available to patients at Saint John’s.