Outcomes 2016 - Baylor Hamilton Heart and Vascular Hospital FY 2016 | Page 35

Robert C. Kowal, MD, PhD Co-Medical Director of Cardiac Electrophysiology, worked closely with a team of investigators on the world’s smallest pacemaker called the Micra ™ Transcatheter Pacing System, which received FDA approval in fiscal year 2016. ON THE FOREFRONT OF LEADLESS PACERS Robert C. Kowal, MD, PhD, Co-Medical Director of Cardiac Electrophysiology, worked closely with a team of investigators on the world’s smallest pacemaker called the Micra™ Transcatheter Pacing System produced by Medtronic. Receiving FDA approval in fiscal year 2016, Dr. Kowal and others helped score (Pictured at actual size. Micra is 93% smaller an industry first with U.S. approval for than conventional pacemakers) commercial use of the leadless pacemaker, Micra. The size of a nickel or paperclip, Micra represents the first entry in what may become a new class of slender, minimally invasive pacemakers that rest entirely inside the heart. Micra attaches to the inner heart wall directly, avoiding the need for insulated wires called leads to deliver the pacemaker’s electric pulses. Leads have been called the “Achilles’ heel” of pacemakers because they can wear out and create infection risk. MICRA ™ TRANSCATHETER PACING SYSTEM Dr. Kowal was involved in the global clinical trial since the beginning for this type of leadless pacemaker that is placed directly into the right ventricle. He also joined other electrophysiologists to present information regarding the importance of physician training as a part of the single-chamber device’s launch at a meeting with the U.S. Food and Drug Administration before they granted approval for Micra’s use. Historically, we’ve been a training site for atrial ablation. Having several ‘firsts’ during fiscal year 2016 in our long list of ‘firsts’ in the field of cardiac electrophysiology continues the tradition at Baylor Hamilton Heart and Vascular Hospital of being in the forefront of cardiology. We are pleased to have advanced technology available as a treatment option for A-fib patients. Kevin Wheelan, MD, FACC Chief of Medical Staff; Co- Medical Director of Cardiology A traditional pacemaker is placed in a “pocket” of skin near the shoulder, and connects to leads strung through major blood vessels to deliver electric pulses to the heart. In contrast, leadless pacemakers fit in a flexible tube the size of a large drinking straw, which is advanced into the heart from a small incision in the leg. Tiny bits of metal on the end of the pacemaker hook or screw into the heart tissue. “Physician training led by the manufacturer was robust. I think that is part of the reason why none of the 725 Micra devices implanted during the trial became dislodged in the heart,” says Dr. Kowal. OUTCOMES 2016 33