The Detroit Medical Center Cardiovascular Institute is the first healthcare provider in Michigan to offer a new breakthrough technology designed to correct atrial fibrillation (irregular heartbeat) in patients who struggle with this potentially life-threatening heart disorder.
The new FDA-approved, state-of-the-art technology — known formally as the “Arctic Front Cardiac CryoAblation Catheter system” — uses a specially designed coolant to chill small areas of heart tissue, in order to better control the electrical signals which determine heartbeat rate.
Atrial fibrillation, the most common heart-rhythm disorder in the United States, occurs when the heart’s upper two chambers lose their natural rhythm and begin to beat erratically. This condition, which currently affects 3 million Americans and 7 million people worldwide, can lead to disabling or even fatal strokes, heart failure or heart disease, if left untreated.
The new “CryoAblation” (inactivation through freezing) technique is specifically designed to treat the most common form of AF, called “symptomatic paroxysmal atrial fibrillation” or “PAF.” In patients with that form of AF, irregular heartbeats in the heart’s upper chambers start and stop suddenly on their own for minutes or even days at a time.
The innovative and minimally invasive new procedure employs a “cryoballoon” (delivered to the heart through an arterial catheter) to bathe electricity-conducting tissue around the heart’s pulmonary vein with coolant. The chilling down of these sensitive tissues prevents them from conducting the erratic electrical signals and thus helps to restore a regular heartbeat.
In the past, many AF patients were treated with therapeutic drugs or with invasive, often traumatic open-heart surgery to repair the electrical defect. But those approaches have often proved unsatisfactory. Fully 50 percent of AF patients can’t be treated effectively with medications, for one thing — and open-heart surgery, which often requires chest-cracking and deep incisions, can leave patients vulnerable to infections, pain and longer hospital stays.
For these patients, the new catheter-delivered therapy offers an effective solution… since the heartbeat-regulating coolant is transported to the heart via a catheter which is inserted into the femoral artery via a tiny incision in the leg. Unlike traditional ablation treatments that use radiofrequency or heat to neutralize faulty electrical circuits in the heart, the balloon-based Arctic Front system ablates the defective cardiac tissue simply by cooling it.
Randy Lieberman, M.D., Medical Director, Electrophysiology Services, the heart specialist who directs the new procedure at the DMC Cardiovascular Institute, said the introduction of the Medtronic CryoAblation system for AF patients was “a major step forward in the effective treatment of this large group of heart patients. This is a proven, FDA-approved medical technology which has already demonstrated its effectiveness in helping AF patients.”
Theodore L. Schreiber, the President of the DMC Cardiovascular Institute, said he was “greatly encouraged by the fact that AF patients in Michigan can now be assured of getting the very latest and most effective treatment for this condition. This technology may also provide improved safety and efficacy, compared to open-heart MAZE procedures and RF ablations.”
Added Dr. Schreiber, a nationally recognized medical innovator who pioneered the development of the stent procedure for relieving blocked carotid arteries: “As a cardiologist, I’m deeply interested in making sure that heart patients get world-class care when they come to the DMC. It’s very gratifying for all of us who treat patients at the CVI to know that our facility is the first in Michigan to make CryoAblation therapy accessible to anyone who needs it.”
Describing the new heart-care technology, Dr. Lieberman noted that if left untreated, AF patients have up to a five times higher risk of stroke and also an increased chance of developing heart failure. He also pointed out that atrial fibrillation is often age-related… which means that as the U.S. population continues to age, the need for more effective AF treatment options will increase.
The new procedure was approved by the FDA last December. According to the STOP-AF (Sustained Treatment of Paroxysmal Atrial Fibrillation) trial, which served as the basis for the FDA approval, 69.9 percent of patients treated with Arctic Front achieved treatment success at 12 months, compared to 7.3 percent of patients treated with drug therapy only. The study also demonstrated that treatment with the device is safe, with limited procedure-related adverse events (3.1 percent), and with a reduction in adverse events caused by atrial fibrillation when compared to drug therapy. Additionally, patients treated with Arctic Front displayed a significant reduction of symptoms, a decrease in the use of drug therapy and substantial improvements in both physical and mental quality-of-life factors.
This new procedure comes immediately on the heels of DMC Cardiovascular Institute’s completion of the first two Medtronic CoreValve transcatheter aortic valve implants ever achieved in Michigan, earlier this month. That procedure was part of CVI’s participation in the Medtronic CoreValve U.S. Clinical Trial. This multi-state trial will evaluate a new, non-surgical alternative to open-heart surgery for patients with severe aortic stenosis.
For more information about the CryoAblation system, visit www.dmccvi.org/arcticfront