A clinical study of a new cardiac ablation procedure for patients with an irregular heartbeat has launched at Beaumont Health, a worldwide leader in the treatment of atrial fibrillation, or AFib.
Researchers at Beaumont, Royal Oak are testing whether pulsed field ablation to treat AFib improves success rate, reduces complications and decreases treatment time when compared to traditional ablation procedures. Beaumont is one of 30 sites around the world - 15 in the United States - and the only site in Michigan participating in the study. Beaumont is also one of the only health systems in Michigan with a center dedicated to treatment of AFib.
“Pulse field ablation provides a concentrated treatment to the part of the heart muscle thought to be the source of the rhythm abnormality,” said Beaumont cardiologist Dr. David Haines, 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, or arrhythmia, can affect the blood flow through the body and lead to blood clots, stroke and the possibility of heart failure.
Atrial fibrillation is the most common type of arrhythmia and affects more than 5.9 million people in the United States. The normal heart rate for an adult is between 60 and 100 beats every minute. When the heart is in atrial fibrillation, the atria (the upper two chambers of the heart) can beat more than 300 times every minute.
Often, medications are used to control AFib. As an alternative, specialized cardiologists – electrophysiologists like Dr. Haines – use ablation to treat the specific area of the heart that isn’t beating correctly. First, the electrophysiology team uses advanced cardiac imaging to map the electrical pulses of the heart and to identify the area misfiring. During the ablation procedure, the team inserts a small wire through a vessel in the groin, then guides it into the area of the heart causing the arrhythmia. Once properly positioned, the electrophysiologist performs the ablation procedure using highly focused electric current or cryogenics to permanently deactivate the spot causing the arrhythmia.
Success rates for current ablation procedures vary between 60% and 75%. For some patients, follow-up includes additional procedures or the continuation of anti-arrhythmia medications.
Initial research has suggested that pulsed field ablation, the procedure being tested in this study, may be more effective at treating Afib without affecting adjacent tissue such as the esophagus or coronary arteries.
“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,” said Beaumont cardiac electrophysiologist and co-investigator Dr. Ilana Kutinsky. “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 study. Results will be reported after the study is complete. The Ohio State University’s Wexner Medical Center and St. David’s Medical Center in Austin, Texas were the other sites in the United States.
The expert team at Beaumont expects to enroll at least 50 patients who experience atrial fibrillation in the current study over the next few months. Patients will be followed as part of the study for about a year to determine the procedure’s success rate.
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;
- be between ages 18 and 80.
Some exclusions include:
- those who have experienced continuous AFib for more than 12 months;
- a prior ablation or left atrial appendage closure procedure;
- the presence of any implanted cardiac device, like a pacemaker or ICD.
Detailed information about the study and additional exclusions is available on the National Institutes of Health’s website.
About 160,000 new cases of atrial fibrillation are diagnosed every year. Nine out of every 100 people over the age of 65 are diagnosed with atrial fibrillation. Although it usually occurs in adults older than 60, younger adults can develop atrial fibrillation, too.
“The irregular heartbeat affects patients in different ways,” said Dr. 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.”
Patients who have early, aggressive treatment soon after their diagnosis of AFib could prevent these long-term outcomes, according to a 135-center study of nearly 3,000 patients in Europe, points out Dr. Haines. Treatment of atrial fibrillation specifically with ablation might provide better long-term outcomes, according to a study recently reported in the New England Journal of Medicine, he added. The study found that those patients who received ablation for their atrial fibrillation were faring better after three years.
For more information on the Pulsed Field Ablation study at Beaumont or for patient participation criteria and evaluation, please contact the Beaumont AFib Center at 248-898-6575.