Local participants, big impact
Clinical trial investigates efficacy of heart device vs. blood thinners
After a 45-minute procedure and an overnight hospital stay, David Orchowski could be done with blood thinners for good. The 72-year-old was first to enroll at Community Hospital to participate in a clinical trial to see whether an atrial fibrillation device can replace the need for blood thinners, which carry a risk of stroke.
Community Healthcare System is participating in the CHAMPION-AF clinical trial, which evaluates the safety and efficacy of the WATCHMAN FLX™ left atrial appendage closure (LAAC) device against blood thinners. One group of study participants received the device, and the other group continued to take blood thinners without having the device implanted.
“Our cardiovascular teams were the first in Northwest Indiana to offer WATCHMAN and the next-generation WATCHMAN FLX as an effective treatment option for these patients,” said Samer Abbas, MD, medical director of Cardiovascular Services at Community Hospital and the Structural Heart program of Community Healthcare System. “We are pleased to participate in this important study that will evaluate whether a one-time WATCHMAN FLX procedure is equally effective as blood-thinning medication as a first-line treatment for a wider population of patients.”
The trial involves patients at low to moderate risk of bleeding from the use of blood thinners, or those who are seeking an alternative to long-term anticoagulation.
“It could be one more tool in the toolbox that doctors have available to them to help people live a longer, healthier life with less fear of a stroke,” Orchowski said.
His path to blood thinner use began after he experienced heart arrhythmia and underwent a cardioversion and a cardiac ablation to help bring his heartbeat to a normal rhythm. After a cancer diagnosis and treatment, and after another cardioversion, Orchowski was prescribed a blood thinner.
He learned about the clinical trial in 2021 during a visit with William Spear, MD, an electrophysiologist with Community Care Network.
“I took the blood thinner Eliquis, and Dr. Spear asked if I had experienced excessive bleeding from a cut or excessive bruising from bumps,” recalled Orchowski, a resident of Chicago’s Hegewisch neighborhood. “I explained that I had, and he mentioned that Community Hospital was looking into doing a clinical trial on the device.”
After enrolling in the study, Orchowski was chosen at random among study participants to receive the WATCHMAN FLX device. His procedure was Oct. 18, 2021, and lasted about 45 minutes. For the procedure, a surgeon cuts an incision in the upper leg near the groin, inserts a narrow tube and guides the WATCHMAN FLX device to the heart, where it is permanently implanted.
“I stayed overnight to be monitored,” he recalled.
The medical team checked Orchowski’s vital signs and drew his blood before he was cleared to leave.
“I had outstanding cardiovascular nurses and technicians,” he said. “Everyone went out of their way to take care of me.”
Participating in the program is not complicated, Orchowski explained. He takes his blood pressure and heart rate twice a day, occasionally answers questions over the phone about his health and meets regularly with his doctor. “I am extremely pleased with how things are going,” he said.
Over the course of the five-year study, Orchowski will have regular check-ins and check-ups, both over the phone and in person. A few months after the procedure, he underwent a transesophageal echocardiogram (TEE) to ensure heart tissue properly grew over the implant to build a barrier against blood clots. Once that barrier forms in patients who received the implant, most stop taking blood thinners and begin taking 81 milligrams of aspirin a day.
“I look forward to being a participant over the long haul,” he said.
Community Healthcare System has a well-established history of providing excellence and innovation in cardiac care, which has distinguished the system as a leading site for clinical trials such as this.
“We are fortunate to have been asked to participate in this study in the company of nationally recognized centers such as Mayo Clinic, Cleveland Clinic and others,” Dr. Abbas said.
Cardiovascular Care
For information about WATCHMAN FLX™ at Community Healthcare System, visit WATCHMAN FLX™.
