Devices & Procedures
St. Luke’s Implants New, Improved Stroke-Stopping Device for AFib Patients
A new and improved version of the Watchman device will increase the chances for more people to live more safely and comfortably with atrial fibrillation (AFib) when they cannot tolerate blood thinners.
Since 2018, St. Luke’s cardiology heart rhythm specialists and interventional cardiologists have been inserting a Watchman in a subset of patients with atrial fibrillation (not caused by a heart valve problem), as an alternative to anticoagulant medicines like Coumadin and warfarin.
This month (Jan. 2021), St. Luke’s Heart & Vascular Center electrophysiologists Steve Stevens, MD, and Christopher Sarnoski, DO, will introduce a new generation of Watchman, the Watchman FLX, which will expand patient eligibility for this one-time treatment to prevent strokes.
Watchman is umbrella-shaped and about the size of a quarter. Using a minimally invasive procedure, doctors position it at the small pouch in the left upper chamber of the heart, called the left atrial appendage, or LAA. The Watchman blocks blood from entering this LAA, where it can form a clot that might escape and flow up and into the brain, causing a stroke.
Patients with AFib can be five times more likely to have a stroke because of the increased formation of blood clots.
Blood thinners are the most common treatment for preventing the clots from forming. But many people with atrial fibrillation cannot tolerate them because they have bleeding issues, such as in their stomach, colon or brain.
Drs. Stevens and Sarnoski implant the Watchman in patients in a sterile, operating-room-like room. They thread the Watchman in a thin flexible tube into the patient’s heart and position a 2-3cm cap-like device that expands and blocks the opening of the left atrial appendage. This procedure takes about an hour during which the patient is under anesthesia. Patients are discharged home the next day with just a small bandage on their groin, and they should feel back to normal immediately.
Patients must take blood thinners for 45 days after Watchman placement, until an imaging study shows that it is covered with internal lining of natural heart cells, called the endothelium, that will keep it in place and prevent blood clots from seeping out of the LAA.
The new Watchman FLX is easier to implant and available in several additional sizes, so it can fit more patients’ hearts with a higher degree of safety and effectiveness. The team of Drs. Sarnoski and Stevens have implanted nearly 40 Watchmans since 2018 with an impeccable safety record.
They are highly selective about whom they choose for this invasive procedure, says Dr. Stevens, trying to implant only in those that would benefit from it.
“Most patients with AFib tolerate blood thinners well,” he explains. “If that works for them, we recommend they continue on this medication rather than undergoing an invasive procedure. Blood thinners can prevent all types of strokes, even those not from atrial fibrillation and not related to the left atrial appendage, whereas, the Watchman only prevents strokes related to the left atrial appendage.”
“We put the Watchman only in the right patient, not every patient with AFib. You can trust that only those who truly need it and will benefit from it will receive it here.”
Dr. Stevens reports that all the patients who received the Watchman are doing well and off blood thinners.
St. Luke’s is the first hospital in Northeastern Pennsylvania--and one of the first in the country--to provide innovative, first-of-its kind treatment for debilitating heart failure.
St. Luke’s patients with desperately weakened hearts may soon find hope in a new pacemaker-like device that prompts the heart muscle to contract more strongly with each beat. Specialists at the Heart and Vascular Center soon will begin implanting the Optimizer system in patients whose failing hearts continue to worsen despite their receiving optimum medical therapy. St. Luke’s is the first hospital in Northeastern Pennsylvania--and one of the first in the country--to provide this innovative, first-of-its kind treatment for debilitating heart failure.
The Optimizer consists of a small electrical generator, surgically implanted under the skin of the upper chest, and two metal wires, or leads, that are inserted into the lower heart chamber, called the ventricle. Generator pulses timed precisely to heartbeats provide “cardiac contractility modulation,” (CCM™) a proprietary clinically proven, new, FDA-approved heart failure therapy that helps the heart squeeze oxygen-rich blood out of the heart to the rest of the body.
“This treatment is a game-changer for heart failure patients who have advanced symptoms and a very poor prognosis,” says Steve Stevens, MD, St. Luke’s cardiologist and heart rhythm specialist, who will implant the first device at the network. Dr. Stevens’ Heart & Vascular Center colleagues Darren Traub, DO, Sudip Nanda, MD, and Hardik Mangrolia, MD, will also perform this life-changing procedure.
“According to extensive research, the Optimizer improves quality of life, changes one’s outlook and has the potential to significantly reduce deaths from Class III heart failure,” adds Dr. Stevens.
Heart failure is a vexing, debilitating and often fatal condition in which the heart muscle, weakened following a heart attack or years of high blood pressure, worsens and is unable to adequately supply oxygen-rich blood to the body. It affects an estimated 6.5 million Americans and nearly 26 million people worldwide. About 7000,000 U.S. patients with Class III heart failure, whose medicines fail to relieve their life-limiting symptoms, could benefit from the Optimizer system.
Persons suffering with advanced heart failure often struggle with progressively worsening symptoms that include reduced energy, shortness of breath and frequent hospitalizations as their heart pumping function or “ejection fraction” declines. A normal ejection fraction is 60 percent.
According to Dr. Stevens, patients with an ejection fraction of 25-45 percent, who don’t get sufficient relief from their medicines, would likely be candidates for the Optimizer device.
This breakthrough heart-improvement technology, FDA approved in 2019, has been clinically shown not only to relieve symptoms but also to help the heart muscle strengthen over time, much in the way a person’s physical exercise enhances their muscle tone and work capacity.
Dr. Stevens and his fellow cardiologist/electrophysiologists will implant the battery-powered device in a sterile, operating room-like environment. Following an overnight stay in the hospital, the patient will be discharged home and soon begin to experience better heart health, including more energy and lifted spirits, he says. The generator must be recharged weekly, which is done at home by the patient.