Blood thinners no Longer the Only Option for AFib Patients
Patients with AFib have a fivefold risk of stroke over those without, often setting them on a lifetime course of blood thinners - and a subsequent risk of bleeding. That all changed in 2020 with FDA approval of the latest WATCHMAN™ Left Atrial Appendage Closure (LAAC) Device, the only permanently implanted device that helps to prevent blood clots in the left atrial appendage from entering the bloodstream.
Andrew Goodman, MD, interventional cardiologist at TriStar Centennial Medical Center's Heart and Vascular Center, said LAAC therapy has taken off since its debut in 2015. The latest model - the WATCHMAN FLX - includes improved safety and anatomical profiles that previously prevented implantation in approximately 10 percent of patients.
"We're seeing much better outcomes with this device, and providers and the public alike are becoming more knowledgeable of this as an option compared to five years ago," said Goodman. "It's been a breath of fresh air." In 2020 the hospital became the region's first to implant this latest model in a commercial patient.
To qualify for LAAC, patients must be candidates for blood thinners but not long-term use. That means most are at high risk for internal bleeding, falls or in a high-risk occupation. When choosing the best treatment for a high-risk patient, Goodman provides AFib patients with options.
The first, he said, is to stay on bleed thinners. "I'll be the first to tell you that the blood thinners we have today are excellent, and the vast majority of patients tolerate them very well, but it does come with an increased risk of a bleeding event," he said.
Another option - coming off blood thinners altogether - means accepting the chance of stroke, which is rarely the preferred choice. The third alternative is a WATCHMAN procedure, which patients often choose when they're between a rock and a hard place. "If someone has a high risk of stroke and a high risk of bleeding, the WATCHMAN is a nice way to get out of that place," Goodman said.
The minimally invasive procedure is well tolerated even by elderly, medically fragile patients, who spend a day in the hospital followed by six weeks on blood thinners. In a clinical study, 96 percent of patients who had the WATCHMAN FLX device implanted were able to stop taking their blood thinning medications after 45 days.
A Welcome Alternative
"The device is inserted into the left atrial appendage, which serves no purpose in the heart except as a reservoir for blood to collect, stagnate and form clots," Goodman explained. "When we put the device there, we wall off that area, so it's completely expunged from the heart or circulation. No blood can get in or out and therefore no clot."
Now, TriStar Centennial is participating in a clinical trial examining whether the stroke reduction tool can be used in a lower risk population - those not at risk for bleeding events. "The technology and results have gotten so good that the question now is, 'Should WATCHMAN be a front line strategy in more people?'" Goodman said.
He also hopes improved outcomes will encourage providers to refer patients earlier. "Often times we'll evaluate patients for WATCHMAN when they've already had a significant bleeding event," said Goodman. "Where we are with therapy now, we're using risk tools to get better at predicting who might benefit from the device before bleeding events occur and trying to move the needle toward earlier intervention."