A clinical study of a new cardiac ablation procedure for patients with an irregular heartbeat has launched at Southfield-based Beaumont Health. The health system is one of 30 sites worldwide, including 15 in the U.S., and the only location in Michigan participating in the study.
Cardiac ablation is a procedure that scars tissue in the heart to block abnormal electrical signals and is used to restore a normal heart rhythm, according to the Mayo Clinic.
Researchers at Beaumont Hospital, Royal Oak are testing whether pulsed field ablation, or very short electrical pulses, can treat atrial fibrillation, or AFib, improve success rates, reduce complications, and decrease treatment times when compared to traditional ablation procedures. AFib occurs when chaotic electrical signals in the two upper chambers of the heart cause an irregular and often rapid heartbeat.
“Pulse field ablation provides a concentrated treatment to the part of the heart muscle thought to be the source of the rhythm abnormality,” says Dr. David Haines, a cardiologist, Beaumont’s principal investigator for the study, and a leading expert in electrophysiology, the science focusing on the electric currents that make the heart beat. “The current technology is good, but it doesn’t work for everyone. So, we’ve been looking for alternative processes for a long time.”
An irregular heartbeat can affect the blood flow through the body and lead to blood clots, stroke, and heart failure.
AFib is the most common type of arrhythmia, or irregular heartbeat, and affects more than 5.9 million people in the U.S. The normal heart rate for an adult is between 60 and 100 beats per minute; when the heart is in atrial fibrillation, the atria, or upper two chambers, can beat more than 300 times every minute.
Medications are often used to control AFib, but electrophysiologists can use ablation to treat the area of the heart that isn’t beating correctly. In ablation, experts find the area of the heart that is affected, insert a small wire into the affected part of the heart through a vessel in the groin, and use electric current or cryogenics to permanently deactivate the spot.
Success rates for the current procedures vary between 60 percent and 75 percent. For some patients, follow-up includes additional procedures or the continuation of medications.
Initial research has suggested that pulsed field ablation, the procedure being tested in the study, may be more effective at treating AFib without affecting adjacent tissue.
“While this treatment has already been through the preliminary safety review approval process – meaning it is safe for patients – the current phase of the study will scientifically evaluate whether pulsed field ablation actually improves outcomes while reducing treatment time and the potential for complications,” says Dr. Ilana Kutinsky, a cardiac electrophysiologist at Beaumont and co-investigator of the study. “So many of our patients deal with atrial fibrillation, so we are always searching for treatment options that help improve their lives.”
Beaumont, Royal Oak was one of six centers in the world participating in the pilot phase of the study evaluating the treatment’s safety. Five patients received pulse field ablation in December at Beaumont, Royal Oak as part of the pilot. Results will be reported after the study is complete.
The team at Beaumont expects to enroll at least 50 patients who experience atrial fibrillation. Patients will be followed for about a year as part of the study.
To qualify for the study, patients must experience recurrent, symptomatic AFib despite the use of antiarrhythmic drugs, have had AFib episodes within the past six months, and be between the ages of 18 and 80.
Some exclusions include those who have experienced continuous AFib for more than 12 months, a prior ablation of left atrial appendage closure procedure, or have the presence of any implanted cardiac device. More information is available here.
About 160,000 new cases of AFib are diagnosed every year. Nine out of every 100 people over the age of 65 are diagnosed with it. While it usually occurs in adults over the age of 60, younger adults can also develop it.
“The irregular heartbeat affects patients in different ways,” says Haines. “Some patients are exhausted after only a few minutes of an irregular heartbeat. Others can function relatively normally. But, in either case, atrial fibrillation increases patients’ long-term chances of stroke, heart failure, or dying. Cognitive decline has also been linked to atrial fibrillation.”