Post-approval Cryoablation Research Streamlines Treatment for Persistent Afib

A post-FDA-approval clinical trial at MedStar Health Research Institute connects patients with first-line Afib treatment, reducing the time from diagnosis to symptom relief.

Atrial fibrillation (Afib) treatment has come leaps and bounds since the development of ablative procedures in the 1980s. In the 21^st century, MedStar Health Research Institute continues to refine technologies that give patients long-lasting, effective relief from Afib symptoms such as irregular heartbeat, chest discomfort, and fatigue.

Among our latest research is the STOP AF First clinical trial, which is evaluating long-term outcomes of patients who had cryoablation therapy—a procedure to freeze errant heart tissue—rather than drug therapy as a first-line treatment for Afib, which is caused by misfiring electrical signals in the heart.

Afib is the most common type of heart arrhythmia, with approximately 160,000 new cases diagnosed in the U.S. each year. Nearly 25% of U.S. adults over 40 are at risk of developing Afib due to risk factors such as obesity, high blood pressure, family history of the condition, and advanced age. The major risk associated with Afib is stroke, withmore than 20% of acute ischemic strokes being associated with Afib.

Our researchers at MedStar Heart and Vascular Institute participated in the initial Sustained Treatment of Paroxysmal Atrial Fibrillation (STOP AF) study, which showed that cryoablation outcomes were superior to medication therapy at centers of excellence like MedStar Health.

STOP AF data, which were published in the New England Journal of Medicine, contributed to the Arctic Front Advance^TM cryoablation catheters by Medtronic, earning expanded U.S. Food and Drug Administration (FDA) approval in 2021 for the treatment of a type of paroxysmal Afib that does not respond to medication.

STOP AF First trial is a post-FDA-approval study to understand whether cryoablation could benefit patients with paroxysmal Afib who have not tried medication as a first line of treatment at heart clinics beyond centers of excellence like MedStar Health.

As one of the largest cardiovascular and electrophysiology research and care teams in the U.S., our mission is to serve patients who might not otherwise get access to state-of-the-art Afib ablation. At the same time, the rich data gathered from our diverse patient populations will help make Afib care more precise and effective for people worldwide.

Afib care is streamlined.

At the time of the first STOP AF trial, patients were still required to try medication for two to three years before they could get a catheter ablation procedure.

Cryoablation for Afib is a minimally invasive procedure in which a specialist delivers -40- to 50-degree cold liquid nitrogen through a thin tube called a catheter into malfunctioning heart tissue. The flexible Arctic Front^TM catheter is equipped with a balloon that we can inflate to expand and better visualize the treatment area.

Unlike radiofrequency, which uses a stiff catheter and heat-based energy, cryoablation reduces the risk of healthy tissue damage, inflammation, and excessive scar tissue buildup.

STOP AF changed the paradigm for Afib treatment in the U.S. Because the study proved cryoablation to be so effective, patients who qualify with persistent, drug-resistant Afib can now get it as a first-line treatment without a long waiting period to try medications. We were a top enroller for STOP AF—a trend we are continuing with the post-approval study.

Post-Approval Study: Wider availability of cryoablation.

The FDA relies on post-approval studies to learn whether positive patient outcomes are due to the therapy itself or to the expertise of the specialists at participating heart centers. STOP AF First aims to determine whether patients will continue to benefit from cryoablation as it becomes more widely available at hospitals throughout the U.S.

MHRI was eager to participate in STOP AF First—these studies are vital to ensuring that the results we see in initial studies translate to the real world. We are the highest enrolling site in the U.S. As principal investigator, I am reasonably confident the data from other centers will continue to validate that cryoablation is better than drug therapy.

At the forefront of Afib ablation research.

MHRI continues to push the envelope on advanced Afib therapies. For example, we have completed several studies of pulsed-field ablation, in which we deliver a high-energy pulse over a fraction of a second to deactivate malfunctioning heart cells. This is the gentlest ablative therapy, which is FDA-approved and available to our patients.

The STOP AF First trial is the culmination of decades of research conducted by cardiovascular and electrophysiology experts at MHRI and nationwide. It is one of the many post-approval studies we have proudly participated in, and there will be many more to come as we refine Afib treatment technology.