OhioHealth Cardiologist Helps With Trial Published in The New England Journal of Medicine
OhioHealth Physician, Anish Amin, MD, who specializes in clinical cardiac electrophysiology, was recently published in The New England Journal of Medicine. Dr. Amin was a co-author in a study coordinated globally by Medtronic, Inc. (Mounds View, Minneapolis) and locally by the OhioHealth Research Institute (OHRI).
The article published, “Efficacy and Safety of an Extravascular Implantable Cardioverter-Defibrillator,” details the global clinical trial that looked into the safety and efficacy of a first-of-its kind defibrillator. The study involved 356 patients involved internationally, and of those 356 patients, 24 were from OhioHealth.
OhioHealth is one of 46 hospitals around the world to participate in the clinical trial. The trial evaluated the safety and effectiveness of the Medtronic EV ICD™ system, a first-of-its-kind extravascular implantable cardioverter defibrillator (EV ICD), in which the lead is placed under the breastbone, outside of the heart and veins, to treat dangerously fast heart rhythms that can lead to sudden cardiac arrest (SCA).
The trial results were presented as late-breaking science at the European Society of Cardiology (ESC) Congress 2022 in Barcelona, and then published in The New England Journal of Medicine.
What is the EV ICD Pivotal Study?
The EV ICD Pivotal study is a prospective, multicenter, single-arm, non-randomized, pre-market clinical study that assessed the safety and effectiveness of the Medtronic EV ICD system for patients at risk of sudden cardiac death. The EV ICD Pivotal study enrolled 356 patients at 46 sites in 17 countries in North America, Europe, the Middle East, Asia, Australia and New Zealand. The trial was sponsored by Medtronic.
What is the Investigational EV ICD System?
The Medtronic EV ICD system is designed to treat dangerously fast heart rhythms that can lead to SCA, while avoiding certain risks of traditional, transvenous ICDs because its lead (thin wire) is placed outside the heart and veins, under the breastbone (sternum) using a minimally invasive approach. Placing the lead in this location helps avoid long-term complications that may be associated with leads in the heart and veins, such as vessel occlusion (narrowing, blockage or compression of a vein) and risks for blood infections.
The lead is connected to a device that is implanted below the left armpit (in the left mid-axillary region). Clinical trial participants received the same therapies provided by traditional ICDs, including defibrillation, anti-tachycardia pacing (ATP, which paces the heart to interrupt and terminate a dangerous rhythm, potentially avoiding a defibrillation shock), and back-up pacing therapies with this single implanted device that is similar in size, shape, and longevity to traditional, transvenous ICDs.
Worldwide, the EV ICD system is investigational and not yet approved for sale or distribution.
Below is a Q&A with Dr. Amin:
1). What is the importance of this study? How does this study benefit both patients and other physicians?
This study highlights the ongoing need for implantable devices to prevent sudden cardiac death with limited long term complications. Traditional devices with wires that pass through the venous system and are implanted within the heart have been demonstrated to result in complications related to wire breakdown, infection and valvular dysfunction. Patients and physicians should recognize that devices which avoid the vascular space can continue to provide life saving therapy without these long term complications. In this study the exceedingly low number of complications, none related to the device itself and the high success for arrhythmia conversion should be highlighted
2). How did you get involved with the clinical trial and role did you play in helping with the findings of the study?
We were invited to participate by Medtronic and our success in enrolling patients provided a firsthand implant and follow-up knowledge that by default made us the experts for this particular device. The findings of the study were generated through diligent data collection and consistent participation from our patients.
3). What are complications, serious health impacts that people could face if fast heart rhythms aren’t taken care of?
The most pressing concerns related to ventricular arrhythmias include death and syncope (passing out). Recurrent arrhythmias even when treated by an ICD can be debilitating.
4). What is the difference between the traditional defibrillator and this new one? Do the two defibrillators target the same area in the body or a different area?
A traditional defibrillator lead is placed through a vein underneath the collar bone which is then guided to the heart where it is affixed. The lead is under constant mechanical stress through cardiac motion and everyday movement of the upper extremity leading to frequent breakage. Similarly, the presence of a foreign body in the blood stream dramatically increases the risk of infection.
Devices which have no wires within the blood stream eliminate the risks of these complications. EVICD hopes to provide an effective means for sudden death protection without long term complications.
5). If someone already has a defibrillator, should they go back in to get this new one?
No. This Medtronic EV ICD defibrillator is investigational and not currently available outside of clinical trials. The role of these new technologies is to provide alternatives for new implants or those individuals with a complication of their existing device. Current defibrillators are FDA approved and the FDA has deemed the risks acceptable for the benefits they provide.
6). Is there an urgency for people to get their devices checked as scheduled? Why?
It is important for patients to have a routine cadence for device follow-up. Often this is accomplished remotely every quarter with an in person visit annually. Follow-up with a physician can be quite variable but is usually every 2 years.