First Two Central Pa. Patients Treated in Landmark Heart Study
On: March 18, 2015 Filed Under: Member News
|HARRISBURG, Pa (March 18, 2015) — PinnacleHealth CardioVascular Institute enrolled and treated the first two patients in the Dual Epicardial and Endocardial Procedure (DEEP) clinical study.
Atrial fibrillation is the most common heart rhythm disorder. It occurs when the electrical signals of the receiving chambers of the heart, known as the atria, break down. Left untreated, it can cause stroke or heart failure.
Atrial fibrillation patients who have failed antiarrhythmic drug therapy and may have received up to two failed catheter ablations are candidates for the DEEP study, which is performed in two phases and uses a procedure known as a hybrid ablation.
The first procedure was performed last week by Mubashir Mumtaz, MD, Chief of Cardiovascular and Thoracic Surgery at PinnacleHealth, who performed the first part of the treatment – a minimally invasive surgical ablation, the first part of the procedure.
“We feel privileged to be part of this landmark study in our quest to find a safe and reliable treatment for millions of people affected by atrial fibrillation,” said Dr. Mumtaz. “We really believe that this trial will provide much needed insight into this disease.”
“What drives us as physicians is the satisfaction of bringing these innovative procedures to our community before they’re available even in major metropolitan cities. Our patients do not have to wait years or travel to get needed treatment,” adds Dr. Mumtaz.
The second phase of the procedure, catheter ablation and endocardial mapping, is scheduled to be performed by Michael G. Link, MD, electrophysiologist at PinnacleHealth CardioVascular Institute.
“We wait 91 to 121 days between the first and second phases of treatment so that the scar tissue from the surgical ablation has time to heal. I also can determine if any of the additional ablation sites need to be completed or re-done and I can access parts of the heart that unreachable through surgery,” said Dr. Link. “
“I am excited about the DEEP study because the more persistent forms of atrial fibrillation have been historically difficult to treat in a minimally invasive manner, with disappointing results,” said Dr. Link. “This hybrid procedure takes the best aspects of each cardiac discipline and puts them together, aiming for a better end result for the patient. I am honored to be at the forefront of this trial which will hopefully alter the standard of care for these patients.”
In the first phase, there are two goals. First, operating through small incisions in the chest, the surgeon ablates the heart using the AtriCure Synergy Isolator ® Bipolar System. Next the surgeon excludes, the left atrial appendage (LAA) with the AtriClip® LAA Exclusion System. For patients with afib, over 90% of clots that potentially lead to stroke, are believed to form in the left atrial appendage
This surgical procedure is considered less invasive than conventional open heart ablations because it is done through small incisions on the sides of the chest near the ribs, instead of one large surgical incision of the breast bone. It also avoids the need for the heart-lung bypass machine, as the DEEP procedure is done on a beating heart.
The target outcomes of the study are freedom from Afib, the most common arrhythmia, and patients not requiring a Class I or III antiarrhythmic drug therapy.
The DEEP Study is one of more than 50 clinical trials for cardiovascular care currently underway at PinnacleHealth.
AtriCure received approval in September 2014 from the U.S. Food and Drug Administration to enroll 220 patients at 25 sites in the DEEP study.
About PinnacleHealth System
PinnacleHealth is a pioneer not-for-profit healthcare system dedicated to improving the health and quality of life for the people of Central Pennsylvania since 1873. A proven leader in medical innovation, PinnacleHealth offers a wide range of services from primary care to the most complex surgeries and Magnet recognition for nursing excellence. The healthcare network includes four campuses (Community, West Shore, Harrisburg and Polyclinic). The new five-story West Shore Hospital includes 108 beds with an emergency department, medical/surgical care, cardiology, orthopedics, chronic disease management, and private patient rooms. PinnacleHealth is part of RiverHealth ACO, an Accountable Care Organization (ACO) in the Medicare Shared Savings Program (MSSP). Medical services, including family practice, imaging, outpatient surgery and oncology are offered at multiple locations throughout the region. For a complete list of services, visit our website at www.pinnaclehealth.org
AtriCure, Inc. is a medical device company providing innovative atrial fibrillation (Afib) solutions designed to produce superior outcomes that reduce the economic and social burden of atrial fibrillation. AtriCure’s Synergy™ Ablation System is the first and only surgical device approved for the treatment of persistent and longstanding persistent forms of Afib in patients undergoing certain open concomitant procedures. AtriCure’s AtriClip left atrial appendage management (LAAM) exclusion device is the most widely sold device worldwide that’s indicated for the occlusion of the left atrial appendage. The company believes cardiothoracic surgeons are adopting its ablation and LAAM devices for the treatment of Afib and reduction of Afib related complications such as stroke. Afib affects more than 33 million people worldwide.3 For more information visit AtriCure.com or follow us on Twitter @AtriCure. More information can be found at www.AtriCure.com.