PHILADELPHIA – Today, electrophysiologists from Penn Medicine implanted the regions first subcutaneous implantable cardioverter defibrillator (ICD) for sudden cardiac arrest, a potentially fatal electrical malfunction of the heart. The patient, a young athletic male in his 20s, had the new system implanted during an outpatient procedure at the Hospital of the University of Pennsylvania (HUP).
"I am very glad we are able to provide this technologic breakthrough. He is an athletic young man who is now protected from life threatening arrhythmias. It is reassuring to not have to worry about problems related to intravascular leads," said Frank Marchlinski, MD, director of the Penn Medicine Electrophysiology Program.
Conventional ICDs require placement of at least one lead in or directly on the heart. Most frequently they are threaded through a vein and then placed inside the heart. The device then monitors the hearts rhythm and delivers a life saving electric shock when a harmful arrhythmia is detected. The new device, known as a subcutaneous implantable defibrillator or S-ICD, works much like an external defibrillator, but the entire system is implanted just under the skin on the chest. A small power unit is placed under the skin on the side of the chest and is attached to a thin sensor and shocking cable implanted under the skin near the breast bone. The new device implantation is part of an ongoing clinical trial that involves 35 sites globally. Penns patient is one of only 330 total patients enrolled in the trial around the world.
"It was great to further reduce the risk of blood vessel or heart injury when implanting these life saving devices. His procedure went smoothly and it will be great to see him back playing sports but fully protected," said Fermin Garcia, MD, Principal Site Investigator for the clinical trial and head of the team that performed the procedure.
The trial is a prospective, multicenter, single-arm design approved in the U.S. by the FDA under an investigational device exemption (IDE). Results from four studies conducted at eight sites in Europe found that the S-ICD detected 100 percent of induced and spontaneous irregular heart rhythms with 98 percent conversion success. They confirmed that the subcutaneous defibrillator helped reduce problems associated with traditional models, including difficulty implanting the leads, risk of damage to the heart or the device, chance of infection and the need to remove a defective or damaged electrode in or on the heart. The device received European approval in 2009 and is commercially available there.
The Penn Medicine Electrophysiology (EP) Program consists of 14 full-time, board-certified electrophysiologists and more than 20 EP specialized nurse practitioners and physician assistants, making it the largest electrophysiology program on the east coast and one of the two largest single hospital programs in the country. All faculty and staff are trained extensively and knowledgeable in all aspects of anti-arrhythmic drug, pacemaker, ICD device and ablation care. In addition, the team has contributed more than 600 scientific publications to the field over the last decade.
Editors Note: Dr. Marchlinski and Dr. Garcia have no financial relationship with the device manufacturer.