New Procedure Extends Coverage in Patients With Non-Valvular Afib

Masked doctors in operating room

As part of its continuing mission to innovate safer, more effective treatments, the Cardiac Arrhythmia Service at Brigham and Women’s Hospital has introduced a new version of a minimally invasive procedure for people with non-valvular atrial fibrillation (Afib). The procedure, which currently uses the WATCHMAN™ FLX device, extends the option of left atrial appendage (LAA) closure to patients who may not have qualified for it before.

“When the original device was introduced about 20 years ago, it provided a major improvement in how we prevent blood clots from forming in the left atrial appendage of the heart,” said Sunil Kapur, MD, an electrophysiologist at the Brigham and director of its Left Atrial Appendage (LAA) Occlusion Program.” It eliminated the need for blood thinners, which one in three patients with Afib can’t tolerate. While previously, the way to eliminate the LAA for those Afib patients that couldn’t take anticoagulation was by open heart surgery, the minimally invasive LAA occlusion device procedure achieved the same goal with less disruption to the patient.”

LAA Treatment Innovation Leads to Same-day Care

To perform the procedure, electrophysiologists access the heart through a catheter in the patient’s leg. A wire is used to extend the small, flexible device to the LAA, where it creates a permanent seal over time. That seal keeps blood clots from forming, escaping the heart and traveling through the bloodstream to other organs, including the brain, where they can lead to a stroke.

Older versions of the LAA occlusion device required implantation under general anesthesia and could take hours. At the time of implantation, patients required a transesophageal echocardiogram (TEE), an ultrasound camera in the stomach to allow for appropriate positioning of the device.

With the utilization of an LAA device, the procedure can be done without general anesthesia but with monitored anesthesia sedation. This allows patients to avoid having an endotracheal (breathing) tube and lowers the risk of damage from the tube. The LAA device can also be positioned using intracardiac echocardiogram (ICE) as opposed to TEE, which avoids the need to place a large camera in the patient’s mouth.

As a result of these innovations, the procedure can be done on an outpatient basis and takes about an hour. The patient goes home the same day.

“We have long known that the LAA is where virtually all Afib-related blood clots form,” Dr. Kapur said. “And Afib-related strokes caused by those clots are among the most devastating types of strokes we see. An LAA occlusion device with ICE placement allows us to target the LAA in a less invasive, safer, easier and quicker way than ever before.”

Heart Size and Shape Are No Barrier

According to Dr. Kapur, while the Brigham has been using an LAA device successfully for years, the procedure wasn’t available to patients whose heart size and shape were a poor match for the earlier versions of the device. Now Brigham physicians can treat a wider range of patient anatomies, with five device sizes available to treat ostia from 14mm to 31.5mm.

“Before we started using an LAA device, about 10 to 15 percent of patients weren’t eligible for the procedure,” he said. “Now, we can treat nearly 100 percent of patients.”

In addition to expanding the treatable patient population, the new device reduces the patient’s metal exposure by 77 percent compared with the previous device, helping to improve the procedure’s safety. It also provides 80 percent more contact points for sealing, which allows for better occlusion of the LAA, reducing the chance of stroke. The device’s fully rounded ball allows cardiologists to safely advance and maneuver within the LAA, and dual-row precision anchors provide optimal device engagement with LAA tissue for long-term stability.

“Because the camera is in the heart itself instead of the stomach, we get better images, allowing us to more accurately place the device,” Dr. Kapur said. “Plus, patients don’t have to undergo general anesthesia, which means quicker recovery.”

Dr. Kapur added that the LAA device, combined with the use of conscious sedation and day-of, pre-procedure CAT scans instead of TEE, reduces the patient’s clinic-visit burden from four to two.

“We conduct the initial patient visit virtually, patients are in and out of the hospital [for the procedure] the same day, the next day they get a virtual post-discharge visit, and then they come back for a follow-up CT scan,” he said. “The whole process is easier for patients and helps them feel more comfortable in the COVID era.”

Collaborating for Success

The Brigham’s LAA Program began about a year ago. Dr. Kapur and other cardiologists in the program work closely with interventional cardiologists, cardiovascular radiologists, cardiac anesthesiologists and cardiac surgeons to address the complex nature of the procedure and variability among patients.

“Our team meets monthly to discuss cases and brainstorm ways we can continue to innovate to address challenges,” he said. “We’re using devices and procedures that are available to other hospitals, but the Brigham brings it all together in an innovative way that makes the procedure even better and safer for patients.”