A new clinical trial is now underway at the Massachusetts General Hospital to investigate whether combining two endovascular catheter-based procedures will improve the long-term outcome in the treatment of atrial fibrillation, the most common heart rhythm disorder. Mass General is the first hospital in New England – and only the second in the nation – to pair renal artery sympathetic denervation with pulmonary vein isolation (PVI) for patients with atrial fibrillation and hypertension.
“Typically these procedures are done separately,” said Moussa Mansour, MD, director of the Atrial Fibrillation Program in the Mass General Institute for Heart, Vascular and Stroke Care. “In this trial, renal denervation is not only performed to treat the patient’s hypertension, which is the usual goal of the procedure, but as an adjunct to PVI to improve the outcome of atrial fibrillation ablation. We see real potential in this treatment for patients who continue to experience atrial fibrillation symptoms in spite of medical treatment as well as for those who cannot tolerate antiarrhythmic drugs. Atrial fibrillation affects more than three million people in the U.S .and is a major cause of stroke.”
On June 17, Mass General physicians used the combined techniques to treat a 60-year-old patient with chronic heart disease. PVI – in which a flexible catheter is passed into the heart through a vein in the leg to disrupt the electrical connection between the pulmonary veins and the rest of the heart – can eliminate atrial fibrillation in most patients. Renal sympathetic denervation uses radiofrequency pulses to interrupt nerves in the vascular wall of the kidney at four sites in a spiral fashion. It is believed that renal artery denervation reduces the activity of the sympathetic nervous system which in turn leads to reduction in atrial fibrillation. The patient will now continue to be evaluated on a regular basis to study the procedure’s effectiveness.
“This procedure capitalizes on the strengths of the electrophysiologists in the use of ablation catheters, and the vascular medicine physician in the imaging of the renal arteries and associate interventions in this locale,” said Joseph Garasic, MD, director of Peripheral Vascular Intervention in the Cardiology Division, Institute for Heart, Vascular and Stroke Care. “It also marks the first time we have performed the renal denervation procedure at Mass General. Increasing evidence has shown that this procedure may have even more far-reaching benefits in the treatment of other diseases beyond uncontrolled hypertension, including heart failure, sleep apnea and cardiac arrhythmias.”
This study, entitled HFIB, is a multicenter, FDA-approved, IDE clinical trial being conducted in the U.S. and Europe. The principal investigator is Vivek Reddy, MD, at the Mount Sinai School of Medicine in New York City, the trial’s coordinating center. The trial is slated to last approximately two years; Mansour and his colleagues at Mass General expect to treat two to three patients a month with the new procedure.
“This clinical trial is unique in that it allows for a solid collaboration and integration of skills between experts in the Mass General Atrial Fibrillation Program and Vascular Medicine Service, both key components of the Institute for Heart, Vascular and Stroke Care,” Mansour said. “This is the most recent and most advanced treatment option to help treat our patients with atrial fibrillation to improve their heart health and their overall lives.”
About the Massachusetts General Hospital
The Massachusetts General Hospital (www.massgeneral.org) is the original and largest teaching hospital of Harvard Medical School. MGH conducts the largest hospital-based research program in the United States, with an annual research budget of nearly $700 million and major research centers in AIDS, cardiovascular research, cancer, computational and integrative biology, cutaneous biology, human genetics, medical imaging, neurodegenerative disorders, regenerative medicine, reproductive biology, systems biology, transplantation biology and photomedicine.
About Massachusetts General Hospital Institute for Heart, Vascular and Stroke Care
The goal of the Massachusetts General Hospital Institute for Heart, Vascular and Stroke Care is to advance the diagnosis and treatment of heart, vascular and cerebrovascular conditions by providing comprehensive patient care while shaping the medicine of tomorrow. Under unified leadership from Mass General’s Corrigan Minehan Heart Center, the Vascular Center and the Stroke Service, the Institute is pioneering a new model that involves complete integration of clinical care and research across disciplines. This patient- and disease-focused model combines basic, translational, and clinical research with the expertise of a multi-specialty panel of expert scientists and clinicians. By bridging multiple disciplines, the leadership of the Mass General Institute for Heart, Vascular and Stroke Care is developing educational programs that reinforce the opportunities offered through integrated care, while also working to address critical issues of health policy and reform.