Nation’s first cardiac ablation with mapping system recently cleared by the FDA performed at Penn Medicine
PHILADELPHIA – After eight years of failed treatment for persistent atrial fibrillation (AF), Janet Szilagyi, 78 of Clayton, New Jersey, became the first patient in the United States to undergo cardiac ablation – a procedure in which an electrophysiologist will scar or destroy tissue in the heart that's allowing incorrect electrical signals to cause an abnormal heart rhythm – using an intraoperative imaging and mapping system recently cleared by the Food and Drug Administration (FDA).
Szilagyi is one of the more than three million individuals in the United States who experience AF, a quivering or irregular heartbeat that can lead to a host of dangerous complications and everyday symptoms like shortness of breath, chest pains, and lightheadedness. Szilagyi had undergone several cardiac procedures and tried different medications to treat and/or control her AF, before coming to Penn Medicine in December 2017 to explore other interventions.
"When I was in atrial fibrillation, it was hard to breathe, and I couldn't walk from here to there without getting tired," said Szilagyi. "I'm usually pretty active; I try to walk every day, but I wasn't able to do that when I was feeling bad. I really wasn't myself." Szilagyi, about six weeks post-op, is home recovering, hoping to get back to her normal activities in the coming months.
"There were many areas of Janet's heart that required ablation, and having access to this new technology allowed us to see more of these regions that we would not have normally been able to, so we could fully address the areas of concerns," said Pasquale Santangeli, MD, an assistant professor of Cardiovascular Medicine, who performed the procedure. "Janet's procedure went well, and she is recovering nicely. I expect that with standard follow-up she will be able to return to normal life without severe threat of AF recurrence."
In October 2017, the system, AcQMap® High Resolution Imaging and Mapping System and the 3D Imaging and Mapping Catheter, received FDA clearance for patients with complex arrhythmias who may need a more extensive cardiac ablation procedure in order to treat the irregularities, based on successful European studies.
Santangeli along with David Callans, MD, associate director of Electrophysiology at Penn Medicine, who performed the country's second procedure with this new system just days later, said the new equipment has the potential to greatly improve treatment accuracy. "Preliminary data from European studies suggests that the success rates of ablation for patients with persistent AF have potential to climb by more than twenty-five percent, and even higher for paroxysmal (sporadic AF) patients," said Callans. "We see these as incredibly promising increases, as these are patients who often still experience symptoms of AF even after they've undergone similar cardiac procedures."
Current data shows that ablation procures are successful for patients with persistent AF about 50 to 55 percent of the time, and about 70 to 75 percent of the time in patients with paroxysmal AF. Researchers believe these numbers could increase to 75 percent and upwards of 85 percent, respectively, if the regions responsible for AF maintenance are adequately addressed with this new system.
Previous systems had only allowed physicians to see certain areas or angles of the heart, which proved challenging when trying to treat more complex cases of AF which require more sites to be ablated. With the new system, higher resolution mapping of the heart is available as it combines ultrasound technology with an ability to map every heartbeat to help pinpoint the cause and placement of each complex arrhythmia. Once an ablation treatment occurs in a specific area, physicians are then able to re-map the heart in seconds to see the effects of each single ablation in real-time. When repeated throughout the entirety of the ablation procedure, physicians can eliminate the arrhythmia-causing areas throughout the heart.
"As a next step, Penn Medicine researchers are exploring clinical trial possibilities, and hope to launch our own trials to evaluate the effectiveness of using this system for patients with complex arrhythmias here in the United States," said Callans.
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 Raymond and Ruth Perelman School of Medicine at the University of Pennsylvania (founded in 1765 as the nation's first medical school) and the University of Pennsylvania Health System, which together form a $7.8 billion enterprise.
The Perelman School of Medicine has been ranked among the top medical schools in the United States for more than 20 years, according to U.S. News & World Report's survey of research-oriented medical schools. The School is consistently among the nation's top recipients of funding from the National Institutes of Health, with $405 million awarded in the 2017 fiscal year.
The University of Pennsylvania Health System's patient care facilities include: The Hospital of the University of Pennsylvania and Penn Presbyterian Medical Center — which are recognized as one of the nation's top "Honor Roll" hospitals by U.S. News & World Report — Chester County Hospital; Lancaster General Health; Penn Medicine Princeton Health; Penn Wissahickon Hospice; and Pennsylvania Hospital — the nation's first hospital, founded in 1751. Additional affiliated inpatient care facilities and services throughout the Philadelphia region include Good Shepherd Penn Partners, a partnership between Good Shepherd Rehabilitation Network and Penn Medicine, and Princeton House Behavioral Health, a leading provider of highly skilled and compassionate behavioral healthcare.
Penn Medicine is committed to improving lives and health through a variety of community-based programs and activities. In fiscal year
2017, Penn Medicine provided more than $500 million to benefit our community.