PHILADELPHIA – Today, electrophysiologists from Penn Medicine implanted the region’s 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 ICD’s 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 heart’s 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. Penn’s 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.
Editor’s Note: Dr. Marchlinski and Dr. Garcia have no financial relationship with the device manufacturer.
Penn Medicine is one of the world’s leading academic medical centers, dedicated to the related missions of medical education, biomedical research, and excellence in patient care. Penn Medicine consists of the University of Pennsylvania School of Medicine (founded in 1765 as the nation’s first medical school) and the University of Pennsylvania Health System, which together form a $3.6 billion enterprise.
Penn’s School of Medicine is currently ranked #2 in U.S. News & World Report’s survey of research-oriented medical schools, and is consistently among the nation’s top recipients of funding from the National Institutes of Health, with $367.2 million awarded in the 2008 fiscal year.
Penn Medicine’s patient care facilities include:
- The Hospital of the University of Pennsylvania – the nation’s first teaching hospital, recognized as one of the nation’s top 10 hospitals by U.S. News & World Report.
- Penn Presbyterian Medical Center – named one of the top 100 hospitals for cardiovascular care by Thomson Reuters for six years.
- Pennsylvania Hospital – the nation’s first hospital, founded in 1751, nationally recognized for excellence in orthopaedics, obstetrics & gynecology, and behavioral health.
Additional patient care facilities and services include Penn Medicine at Rittenhouse, a Philadelphia campus offering inpatient rehabilitation and outpatient care in many specialties; as well as a primary care provider network; a faculty practice plan; home care and hospice services; and several multispecialty outpatient facilities across the Philadelphia region.
Penn Medicine is committed to improving lives and health through a variety of community-based programs and activities. In fiscal year 2009, Penn Medicine provided $733.5 million to benefit our community.