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The London Health Sciences Centre (LHSC) is the first in Canada to implement a new cutting-edge device. The device received Health Canada approval after the LHSC team participated in a global study to prove safety and efficacy.
In a Canadian first, the LHSC was the only hospital in Canada to implant the extravascular implantable cardioverter defibrillator (ICD) during clinical trials. The approval came after the publications in New England Journal of Medicine and, most recently, Circulation, which have shown the long-term safety, efficacy and performance of the device.
56-year-old Ian McCulloch is the first patient in Canada to receive an ICD. He first heard about the device 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,” said Ian. “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.”
The long list of heart issues throughout his family history has made this issue an exceedingly personal one.
“At the very least it’s given me a sense of relief, so if there was something that were to happen to me like it did my brother, then hopefully I’d be taken care of,” said Ian.
Through Dr. Jaimie Manlucu, Cardiac Electrophysiologist at LHSC, McCulloch was enrolled in a clinical trial for the Medtronic Aurora Extravascular ICD device. Dr. Manlucu was a key member of the International Steering Committee and site Principal Investigator on the pivotal trial.
“I was involved from the beginning – We were the only hospital in Canada to implant during the trial, and then we were the first in Canada to implant the device after it was released on the market.”
A total of 356 patients participated in this study across 17 countries and 46 medical centres worldwide, demonstrating the safety of the ICD implantation procedure and its effectiveness in treating life-threatening arrhythmias.
Unlike traditional devices, this new device is implanted outside the vascular system and heart, providing life-saving 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.
“We’ll continue to monitor patient experience. We’re working on developing a new committee to see whether we can expand the type of patients this device can be implanted in,” said Dr. Manlucu.” Right now, they can’t be implemented into patients who have had previous heart surgeries. So, one of the next steps will be to figure out how to get the wire into the space if they’ve had surgery before.”
Although the procedure took place in 2021, Dr. Manlucu notes that Ian’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.
