The Texas Cardiac Arrhythmia Institute (TCAI) at St. David’s Medical Center became the first facility in the United States to use the multi-electrode nMARQ Pulmonary Vein Isolation System™ to treat paroxysmal Atrial Fibrillation (A Fib) as part of the reMARQable clinical study. Andrea Natale, M.D., F.H.R.S., F.A.C.C., F.E.S.C., cardiac electrophysiologist and executive medical director of TCAI, performed the first case in the United States, and he was among the first to use this new catheter in Europe. “The first case proved successful, and I am encouraged by the possibilities of this new system,” Dr. Natale said. “It could give us another tool to more effectively treat patients with paroxysmal A Fib.”
A Fib is a heart rhythm disorder that affects approximately 15 million people worldwide. During A Fib, the heart’s two small upper chambers (the atria) quiver instead of beating effectively. Because the blood is not pumped completely out of the atria, it may pool and clot. If a piece of that blood clot leaves the heart and becomes lodged in an artery in the brain, a stroke can occur. Paroxysmal A Fib is a type of A Fib in which the irregular heartbeat speeds up very quickly, stops spontaneously and abruptly returns to the normal rhythm.
The reMARQable study is designed to evaluate the safety and effectiveness of the use of the nMARQ Pulmonary Vein Isolation System to treat A Fib. During ablation, physicians isolate pulmonary veins—the primary drivers of A Fib—from the rest of the heart. Doctors then use catheters to deliver energy to portions of the veins to create scars, or lesions, to prevent the abnormal signals that cause A Fib from reaching the atrium. The nMARQ system consists of a multi-electrode, irrigated catheter ablation system, which may allow for faster, more effective isolation of the pulmonary veins.
Traditionally, physicians create multiple single ablations to form a line of lesions. The nMARQ catheters are designed to create long continuous linear lesions in one application. Additionally, the irrigated catheters can increase safety by cooling the electrodes, preventing a condition known as char formation. During catheter ablation, the high temperatures can burn the blood, causing it to accumulate on the catheter tip. When char formation occurs, it can prevent deeper penetration of the tissue, causing an imperfect lesion. Additionally, if a portion of the char formation breaks off, it can enter the blood stream and cause a stroke.
The nMARQ Pulmonary Vein Isolation System, manufactured by Biosense Webster, Inc., has not yet received approval by the U.S. Food and Drug Administration for use outside this clinical trial. TCAI is the first of up to 50 sites in the country to participate in this Investigational Device Exemption study.
Texas Cardiac Arrhythmia Institute
Texas Cardiac Arrhythmia Institute (TCAI) at St. David’s Medical Center is one of the world’s preeminent centers dedicated to the latest treatment advances for correcting abnormal heart rhythms such as Atrial Fibrillation (A Fib). The center is led by Executive Medical Director Andrea Natale, M.D., a world-renowned expert in the field. Natale is at the forefront of advancing treatment for A Fib, leading numerous clinical trials and participating in the development of new technologies and procedures.