Having had two minor strokes and a heart attack due to atrial fibrillation prior to the PREVAIL trial, Edna Zander is celebrating one year since having the WATCHMAN® Device implanted and said she feels great.
Thirty-two patients in St. Louis with atrial fibrillation have benefitted from Mercy Hospital St. Louis’ participation in the PREVAIL clinical trial, comparing the WATCHMAN® Left Atrial Appendage Closure Device to long-term warfarin therapy.
The PREVAIL trial registered its 400th patient in June, officially completing “randomized” enrollment period of the trial. Mercy ranks third nationally among trial sites for the number of patients enrolled and is the only trial location in the St. Louis area.
The next phase of the trial allows all patients who meet the criteria to have the WATCHMAN® Device implant without being randomized to warfarin therapy alone.
“This is an incredible opportunity for our patients,” said Dr.Mauricio Sanchez, Mercy electrophysiologist and principle investigator for the trial. “Patients who have received the device have done extremely well and are grateful to not only be off blood thinners but have a decreased risk of stroke as well.”
The WATCHMAN® Device is designed to keep harmful blood clots from entering the patient’s blood stream, causing a stroke. Patients with atrial fibrillation, the most common heart-rhythm disorder affecting over 5 million people worldwide, are at an increased risk of stroke because blood can pool in the left atrium appendage (LAA) ultimately forming clots.
Typically patients with AF take blood thinning medications, such as warfarin, for life to prevent these clots from forming in the heart. These medications require frequent monitoring and have diet and other drug interactions causing compliance issues.
Zander was on blood thinners after her stroke but had side effects so bad that her cardiologist took her off the blood thinners. “He said it was more dangerous for me to be on them than what could happen if I was off.”
The procedure to implant the WATCHMAN® Device into the heart is done via a flexible tube (catheter) through a vein in the groin. The device is designed to prevent blood flow into the left atrial appendage potentially reducing the risk of stroke and eliminating the need for long term use of blood thinning medications.
“I am living proof that it is a good procedure with little discomfort and a chance to get off Coumadin,” Zander said. “I want others to know about the option and ask their doctors about the trial.”
The WATCHMAN® Left Atrial Appendage Closure Technology was developed by Atritech, Inc., headquartered in Minneapolis, Minn.
Mercy Heart and Vascular Hospital, celebrating five years as St. Louis’ only dedicated heart hospital, is a comprehensive care center, including 96 private inpatient heart care rooms, diagnostic services, cardiovascular operating services, a cardiac catheterization lab, cardiac rehabilitation services, education resources and physician offices.