First-of-its-Kind Defibrillator Offers Protection with Less Risk to the Heart
January 6,2012
Ridgewood NJ, Valley Electrophysiologists are the First in Northern New Jersey to Use Newly Approved Implantable Defibrillator That Does not Require a Lead That Connects Directly to the Heart
January 3, 2013 — Although implantable cardioverter-defibrillators (ICDs) have been used for decades to safeguard patients at risk for experiencing sudden cardiac arrest, their major drawback has been the electrodes (“leads”), which can break, become infected, or injure the heart and surrounding blood vessels.
A new ICD that is implanted entirely under the skin (subcutaneous) is now available at The Valley Hospital, the first in northern New Jersey and one of only three hospitals in the tri-state area where this revolutionary device is available to patients deemed at high risk for sudden death due to a heart rhythm disorder (arrhythmia).
The S-ICD differs from traditional ICDs in several important ways, most notably:
• The S-ICD is inserted with a single lead near the heart, leaving the heart and surrounding blood vessels free from intrusive devices.
• The procedure to implant the S-ICD is less invasive.
• Because no leads enter the heart or blood vessels, there is less risk of common ICD complications such as blood clots or infections.
“The S-ICD® is the world’s only subcutaneous ICD, and it represents a major step forward in the evolution of defibrillator technology,” says Mark W. Preminger, M.D., director of implantable devices at the Valley Arrhythmia Institute. “We are delighted to offer this advanced breakthrough in arrhythmia treatment to our Valley Hospital patients.”
In late November, 26-year-old Kevin Taylor Sisti became the first patient at Valley to receive the new S-ICD after a lead in his previously implanted traditional ICD fractured. Electrophysiologists at the Valley Arrhythmia Institute were among a select few in the United States to have first use of the S-ICD based on their vast experience, expertise, and research in the diagnosis and treatment of patients with arrhythmias. They have since implanted several other S-ICD devices.
An ICD delivers an electrical shock to a heart that beats too fast (ventricular tachycardia) or quivers uncontrollably (ventricular fibrillation). The shock jolts the heart into resuming its job of pumping blood to the rest of the body. An S-ICD provides the same protection from sudden cardiac arrest as other ICDs but without a lead that sits within the heart and without the need for fluoroscopic (X-ray) guidance to implant it into the patient. In research studies, it has proven to be 100 percent successful in treating severe arrhythmias.
“The ICD lead has long been considered the Achilles’ heel of ICD systems,” says Suneet Mittal, M.D., director of the Valley Arrhythmia Institute’s Electrophysiology Lab, who was instrumental in bringing the S-ICD to the hospital. “For some patients, the fear of lead-related complications has kept them from proceeding with ICD therapy that would otherwise be potentially lifesaving. In others, the condition of their blood vessels would have made it impossible to implant an ICD. The new S-ICD removes these barriers and opens up this technology to more patients who otherwise would not have received an ICD.”
Research has also shown that the S-ICD can distinguish between a normal heart rhythm and an abnormal one twice as accurately as a standard ICD.
“Patients may be spared unnecessary shocks with an S-ICD,” states Dr. Preminger. “This technology will likely become the treatment of choice for many patients receiving defibrillators; however, not all such patients are candidates for the S-ICD. Patients who require concomitant pacemaker therapy or heart failure therapy will still require conventional devices.”
According to the Heart Rhythm Society, sudden cardiac arrest is the leading cause of death in the United States, claiming more than 350,000 children, teens, and adults per year. Without immediate emergency care, death follows within minutes. Approximately 92 percent of those who are stricken do not survive.
The S-ICD is placed under the skin using small incisions instead of through the blood vessels near the heart. An S-ICD has two components: a pulse generator placed under the left arm, which powers the system, monitors heart activity, and delivers a shock if necessary; and an electrode that sits alongside the heart, senses the cardiac rhythm, and delivers shocks when necessary. Neither component touches the heart or surrounding blood vessels.
Sisti, of North Haledon, was born with a congenital heart defect called transposition of the great arteries. His aorta and pulmonary artery, which carry blood to and from the heart, were switched and required surgery when he was just 3 months ago. At age 15, he received his first ICD to guard against sudden cardiac arrest and a pacemaker to regulate his heart beat. A second ICD was implanted when he was a freshman in college. When one of the second device’s leads broke and required removal, he became the ideal candidate for Valley’s first S-ICD.
After an overnight stay following the implantation procedure, Sisti returned home and was back to work within one week.
“The S-ICD is more comfortable, and my recovery was easier than with the other ICDs,” he says. “I feel safe that this device will save my life if my heart needs the shock. Tests showed I no longer need a pacemaker.”
For the next year, Sisti will return several times to Valley for an evaluation of the device. As of yet, an S-ICD cannot be checked transtelephonically (over a telephone connection) as current ICDs can be. But that is probably just a matter of time, says Dr. Preminger.
“ICD technology has improved in leaps and bounds since first introduced in 1985 and has saved countless lives,” says Dr. Preminger. “The S-ICD opens up the device’s potential for even more lives to be saved.” Despite this, it may not be well suited for every patient at risk for sudden cardiac arrest. It cannot pace the heart so some patients with heart failure or those with a slow pulse will still need a conventional defibrillator with pacemaker capabilities.
Both Drs. Preminger and Mittal point out that those who may be well-suited for an S-ICD include patients with congenital heart disease; those with blood vessel complications that would preclude them from receiving a traditional ICD, such as patients on hemodialysis for kidney failure; and patients whose lifestyle involves repetitive activities that place stress on ICD leads (such as weightlifting and swimming).
Electrophysiologists at the Valley Arrhythmia Institute provide a full range of the most effective diagnostic tests and treatment for heart rhythm disorders. Advances include robotic ablation procedures, Stereotaxis Niobe technology, pacemakers, ICD technology, and cardiac resynchronization therapy devices. For more information, contact 201-HEART-DR (201-432-7837) or visit www.valleyheartandvascular.com/programs-services/electrophysiology.