November 13, 2024
In a Canadian first, London Health Sciences Centre (LHSC) was the first and only hospital in Canada to implant a new extravascular implantable cardioverter defibrillator (ICD) during clinical trials. The global study has led to Health Canada approval of the device following publications in New England Journal of Medicine and, most recently, Circulation, which have shown the long-term safety, efficacy and performance of the device.
In Canada, approximately 25,000 pacemakers and 7,000 ICDs are implanted each year making it essential for patients to receive the best device for their comfort and overall health.
56-year-old Ian McCulloch first heard about implantable cardiovascular defibrillators when he started noticing that his heartbeat was irregular. “Several years ago, I started feeling what I thought was a heavy beat, or what was an extra or missed beat. My wife encouraged me to call my doctor, and I was referred to a cardiologist, and that led to me being asked if I wanted to be part of a study.”
Through Dr. Jaimie Manlucu, Cardiac Electrophysiologist at London Health Sciences Centre (LHSC), McCulloch was enrolled in a clinical trial for the Medtronic Aurora Extravascular ICD (EV-ICD) device, a new and innovative defibrillator that was being studied for current and future cardiac patients. Dr. Manlucu, also a scientist at London Health Sciences Centre Research Institute (LHSCRI), was a key member of the International Steering Committee and site Principal Investigator on the pivotal trial
A total of 356 patients participated in this study across 17 countries and 46 medical centres worldwide, demonstrating the safety of the EV-ICD implantation procedure and its effectiveness in treating life-threatening arrhythmias.
“LHSC and some of my senior partners have had a significant role in helping develop the technology that we see in the defibrillators that we use day-to-day", says Dr. Manlucu. “I’ve been able to see this from the preliminary stages all the way through to the trials. It’s exciting to be part of the next generation helping to continue forward that partnership and effort in developing this technology.”
Unlike traditional devices, this new device is implanted outside the vascular system and heart, providing life-saving arrhythmia treatment. The smaller battery and placement in the body offers better comfort and care for the patient and reduces the frequency of subsequent battery replacement procedures.
Most standard defibrillator devices are typically inserted within the vascular system and are much larger and can sometimes cause discomfort. Dr. Manlucu notes that advancements in medical technology mean that many patients now outlive their devices, which leads to replacements or battery changes.
“We have provided feedback that has guided the device’s development from the early stages to its current use across Canada,” says Dr. Manlucu. “Seeing the device evolve through clinical trials to now helping patients is very exciting.”
Although the procedure took place in 2021, Dr. Manlucu notes that McCulloch's ability to maintain his daily routine as a young and active individual serves as additional proof of the success of both the procedure and device.
Health Canada approved the new device earlier this year, and LHSC has already performed six procedures using it.
For McCulloch, he admits it is an honour to be the first in Canada to receive this device, but mostly feels fortunate that he was able to have this done when he did. “It makes me feel proud! I’m glad to hear that a few more people have been able to do this now and I hope future patients have just as much success as I have.”
McCulloch adds that he feels he has a new lease on life. “I can play volleyball or basketball pickup games and have no restrictions or mobility issues. I feel great!”