Cardioversion (for Atrial Fibrillation)
A New Device Allows Atrial Fibrillation Patients to Get Off Blood Thinners
Side Effects of Blood Thinners
Unfortunately, side effects abound, including bleeding problems, bruising, swelling, discomfort, pain, headaches, and dizziness. In addition, people taking anticoagulants must limit their intake of leafy green vegetables, known for their high levels of vitamin K, which interferes with the effectiveness of the medication.
Regular blood draws, ranging from every week to every month at the doctor’s discretion, are also necessary to determine how quickly blood is clotting and whether the dosage should be adjusted.
Patients worry about falling and injuring themselves, which can lead to bleeding while taking blood thinners. They don’t like having to watch what they eat or commit to regular follow-up.
In fact, a full 45 percent of patients who should be taking blood thinners, do not take them. Even among users of newer medications that don’t require dietary restrictions or regular follow-up, only 75 percent continue taking their medication – thus illustrating the challenges of existing treatments.
A New Device That Helps Prevent Blood Clots
In response, researchers developed an alternative: a device that shuts the left atrial appendage of the heart, which is believed to be responsible for 90 percent of all blood clots.
Introducing the Watchman – the only catheter-delivered heart implant of its kind approved by the Food & Drug Administration (FDA). Approval came on March 13, 2015, after 10 years of testing.
Within 90 days of treatment with the Watchman device, 95 percent of patients are able to stop taking their anticoagulant medications without increasing their risk of stroke.
Who Is Right for the New Device?
Top candidates for the procedure include:
- Patients who are age 65 and older with strong risk factors for vascular disease, congestive heart failure, and hypertension
- Those who have had unfavorable experiences with blood thinners
- Those who have stopped taking the medications they're prescribed
Extensive U.S. trials, funded by Boston Scientific, looked at outcomes for more than 1,100 patients who participated in randomized, controlled trials throughout a 10-year period. Risks of treatment include those typically associated with anesthesia, and a 1 percent chance of a hole in the heart as a result of the procedure.
More New Devices for Atrial Fibrillation in Development
Introduction of the Watchman triggered the production of a cascade of similar atrial-appendage closure devices, including the Lariat, which Beaumont Hospital, Royal Oak, Michigan, began testing about three years ago.
The Lariat procedure, performed under general anesthesia, uses two catheters. The first, carrying the FDA-approved Lariat suture delivery device, is inserted under the patient’s rib cage. The other, which guides it into place, is sent to the heart's left atrial appendage.
Side effects of the Lariat procedure, including pericarditis (inflammation of the pericardium, the fibrous sac surrounding the heart, causing chest pain), have resulted in Beaumont’s tempering its investigation of the device. Further contributing to Beaumont’s lukewarm embrace: FDA-approval of the Lariat is not based on randomized trials comparing outcomes to blood thinner use. Instead, FDA approval of the Lariat hinged on comparisons to surgical treatment for atrial fibrillation.
By contrast, the Watchman was approved by the FDA based on randomized trials comparing outcomes to that of blood thinners. This means Watchman data is much more robust.
Other left-atrial appendage closure devices, including the Amplatzer, Cardiac Plug, and Coherex are currently being investigated in Europe, but head-to-head comparisons with the Watchman are not available.
Where to Find the Watchman
Cardiologists at Beaumont Hospital contributed to all of the trials that led to FDA approval of the Watchman. Medicare and third-party insurer coverage is expected. Due to rigorous training requirements for the doctors implanting the devices, Watchman treatment is initially available at a handful of medical centers throughout the country which will also serve as training sites.
Steven Almany, MD, of Beaumont Hospital, has been practicing cardiology for more than 30 years. He is an associate professor with the Oakland University William Beaumont School of Medicine in Rochester, Michigan. Dr. Almany was recognized in 2013 and 2014 with the Best Doctors in America award and selected for Hour Detroit Magazine’s Top Docs award 2009-2012. His interests include interventional cardiology, coronary artery disease, and research on valvular disease. Beaumont’s Watchman research was funded by Boston Scientific but Dr. Almany did not personally receive any financial compensation for his role on the project.
Video: A New Option for Preventing Stroke from Atrial Fibrillation (AFib)
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