Retired hockey player Gaetano Orlando is alive today because he joined a clinical study using a special vest to monitor heart function after being diagnosed with congestive heart failure, following the advice of his University of Rochester Medical Center cardiologist.
A few short weeks later, his heart rhythms went haywire and the wearable external defibrillator delivered a therapeutic shock to restore an orderly heartbeat. Orlando was without a heartbeat for about 40 seconds before the vest sent the jolt of electricity into his chest.
“It saved my life and the vest did its job,” Orlando said, referring to the LifeVest® wearable defibrillator he’d worn prior to his episode of arrhythmia – or chaotic heart beat – on May 22, just six weeks after he began wearing the vest.
Some people with advanced heart disease who are at risk of sudden cardiac arrest may be encouraged to wear the vest, which continuously monitors heart rhythms and offers a safety net for patients. LifeVest was approved by the FDA in 2002.
URMC cardiologist Eugene Storozynsky, M.D., Ph.D., is leading a study of 100 people who were recently diagnosed with congestive heart failure to assess how their diagnosis impacts arrhythmias over a three-month period. Participants wear the vest to monitor heart activity while having a “safety net” if their heart fails. There are more than 30 people currently in the URMC clinical trial and Orlando’s arrhythmia was the first to require the vest to activate, allowing doctors to closely study the activity leading up to the incident.
According to the American Heart Association, about one-third of all Americans have some form of heart disease, including high blood pressure, coronary heart disease, heart failure, stroke and other conditions. More than 5.5 million people suffer from heart failure and 2.2 million people have arrhythmias.
Wearable defibrillators, like LifeVest, are made of lightweight fabric and worn under clothing. Patients attach a series of wires, called leads, to their chest and the vest’s battery-powered monitor records heart rhythms. Implantable cardioverter defibrillators, or ICDs, are stopwatch-sized electronic devices that are inserted under the skin in the chest to continuously monitor the electrical activity of the heart.
“Based on the data from trials, there are questions about whether or not defibrillators should be put in and when. We know if we implant them too quickly, some patients experience complications and derive no benefit,” said Storozynsky, assistant professor of Cardiologyand a specialist in the URMC Program in Heart Failure and Transplantation. “But if we wait too long, outcomes may be poor. So we’re looking at that critical 30- to 60-day timeframe when we know patients are sick but not quite sick enough for an implantable defibrillator yet.”
“We don’t know which patients may develop arrhythmias when they are diagnosed with heart failure. By using the vest, which records all heart activity, we’re trying to see if there are common factors among patients that might predispose them to these arrhythmias,” Storozynsky said.
Orlando remembers feeling light-headed and then waking up on the floor, near an overturned chair, in his home office. When he regained consciousness, the former hockey player for the Buffalo Sabres and Rochester Americans called for an ambulance and felt normal again by the time paramedics arrived.
The emergency responders transported him to Strong Memorial Hospital’s Emergency Department, and Storozynsky reviewed data recorded in the vest and determined Orlando needed more aggressive monitoring and treatment. Cardiologists implanted a defibrillator two days later.
The study, funded by manufacturer Zoll Medical Corp., is another step in the Medical Center’s long history of leadership in heart failure management and research.
Research by Rochester scientists, led by cardiology expert Arthur Moss, M.D., has changed the standard of care for people with early heart disease, arrhythmias and sudden death. Among Moss’ more than 550 publications are studies from the MADIT (Multicenter Automatic Defibrillator Implantation Trial) series of trials that demonstrated that preventive therapy with an ICD significantly reduces the risk of death in heart attack survivors. The finding, published in the New England Journal of Medicine in 2002, changed medical guidelines nationwide and led to the use of ICDs in millions of patients each year.