EV ICD Pivotal Study: Will This Eliminate Complications?

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EV ICD Pivotal Study: Will This Eliminate Complications?


The EV ICD Clinical Trial And The History Of Defibrillation Using The Extravascular ICD

We are all aware that implantable defibrillators are the most effective kind of treatment now available to prevent sudden cardiac arrest. But because of the difficulties that are connected to leads, namely transvenous leads, there has been an interest in developing systems that do not utilize, that do not need transvenous leads, the potential difficulties linked with leads.


Valvular regurgitation, injury issues connected to extraction when it is necessary, and venous thromboembolism are all possible outcomes. Then there is the danger that is connected with the implantation, such as a pneumothorax. There, the existing subcutaneous system is highly successful; but, because of the distance between the ex and the subcutaneous system, it is not possible to achieve the same level of effectiveness.

The medical device is larger and sends eighty gems to the heart. Additionally, it has a larger size. The idea behind the Extravascular Implantable Cardioverter Defibrillator (EV ICD system) was to have a system that is not in the heart to eliminate all of the complications associated with the leaded system and to place the lead behind the sternum so that it's in a juxtaposition to cardiac tissue so that the amount of energy needed for delivering defibrillation therapy would be lower. This was accomplished by placing the lead behind the sternum.

Pacing for the treatment of atrial flutter can be both provided and paused. It is possible to provide both prevention and pacing. Because of this, the extravascular system was developed to perform this function, and an important study has shown that this is indeed the case. It was easy to carry out while remaining risk-free.

Please Review the Current Standard of Care.

Regarding the effectiveness and security of an extra vascular EV ICD (system) clinical trial, you could say that. Participants in the EV ICD (system) trial were required to have either a class 1 or class 2 indication for the use of a defibrillator. Patients who had undergone bypass surgery in the past or who had thoracic abnormalities or a history of pericarditis in the past were not allowed to participate in this initial pivotal study because these conditions could make it difficult to insert a lead. The goal of the clinical study was to show that the tool worked, which was both the reason for using it and the reason for the study.

and that it was safe Its effectiveness was defined as the ability to successfully terminate ventricular tachycardia arrhythmias, and its safety (endpoint) was related to any major complications that were associated with the implant operation or follow-up through six months. The results of the test showed that the medical device was, in point of fact, quite successful, as the researchers had hypothesized.

The percentage of patients for whom successfully delivering defibrillation therapy was performed was 98.7%, which was significantly higher than the pre-defined performance goal of 88%. And in a similar fashion, the safety threshold with EV ICD system or procedure associated issues at six months was 90, and freedom from was 92.6%, which was higher than the pre-specified performance objective of 79%.

So, the EV ICD (system) trial proved that the extravascular implantable cardiac device (ICD) needed it, but it still met its safety (endpoint) and performance (to help prevent sudden cardiac death) standards.


How Is The EV ICD (System) Trial Set Up?

A few aspects of the EV ICD (system) trial that, upon further consideration, might prove to be fascinating Before anything else, this apparatus is positioned so that the lead is underneath the sternum, which is not a location. An electrophysiologist is a typical specialist that cardiologists access. Therefore, the demonstration that an experienced electrophysiologist could be effectively trained to perform the procedure was an important factor to take into consideration. This demonstration required a training program with cadavers and animal labs, and the first few cases had to be done in front of a cardiac surgeon.

Frequently, not in an operating room setting, but rather in the controlled atmosphere of an EP lab. In point of fact, investigation revealed that to be the situation. However, that is a significantly different form than what I was expecting. So, in the manner that the implant procedures are carried out in the process suite, there is a tunneling instrument that is moved forward once the sternum has been dissected and brought closer to xIPHi.

In addition, this tunneling tool resembles a metallic rod, which can be seen on fluoroscopy, and it is positioned directly behind the ship's stern. Additionally, it is observed in the lateral fluoroscopic view, which enables one to see quite clearly where it is situated in relation to the sternum. After it has been put into place, it is removed, and in its place, a standard sheet is left for the deployment of a lead.

The lead was successfully deployed in the substernal position, and the success rate for doing so in this new location was 99%. They were all practically effortlessly put into action without a hitch. To demonstrate, once more, both the safety and effectiveness of the medical devices, as well as the fact that these new sorts of medical devices could be administered by cardiologists, was an essential component of the EV ICD (system) trial that needed to be tested.

Your Journey Through Studying Cardiovascular Medicine

Since you asked about my interest in cardiovascular medicine, I've always been interested in the field. My interest in physiology began early on, particularly in the physiology of the cardiovascular system. In fact, I was initially matched in an anesthesia program; however, I discovered that the care of patients with cardiovascular disease, the opportunity to make a difference, the opportunity to manage acute and chronic disease, and truly advance science was so appealing that I decided to switch to that instead.

I consider it a great honor to be able to work in the field of cardiovascular medicine and to take part in fascinating studies that test out innovative treatments and technology that can improve patient outcomes in novel ways. We couldn't even let a man try to imagine what I was working toward in my training.


What Are Your Hopes for the EV ICD (System) Trial?

When you first get a very robust and optimistic signal, there are a few things that you should keep in mind, including the fact that we still need to identify them in more general populations. It is put to use. In the United States, the medical device is now going through the process of getting approval from the government.

Even if it does occur, I believe that we will continue to grow as learners as we always have done with extra experience. Who stands to gain the most? How effective are the treatments for avoiding SL heartbeats, and how frequently can we apply them? Will it help prevent sudden cardiac death and help cardiac rhythm? These are the anti-bradycardia pacing therapies. And, the early indications are that they are typically extremely well tolerated. However, it is unclear how well they are tolerated, in which patients, and whether or not there are other implant techniques that could make pacing more or less well tolerated. Therefore, I believe that there is a great deal of nuance to be learnt about how we might most effectively use the new tool.


Final Thoughts On The EV ICD (System) Trial

In conclusion, the extravascular implantable cardioverter defibrillator (ICD) was shown to be both safe and efficacious in this prospective worldwide EV ICD (system) clinical trial. In addition, this is an early experience, but it is a promising one that shows that we now have a new tool in our arsenal to prevent sudden cardiac death to administer antitachycardia pacing and pause prevention pacing. This is applicable to patients who have not undergone a sternotomy in the past.


Paul Friedman, MD—About The Author, Credentials, and Affiliations

Dr. Paul Friedman is not only a professor of medicine at the Mayo Clinic in Rochester, Minnesota, but also the head of the department of cardiovascular medicine there. He is board-certified in cardiovascular medicine and cardiac electrophysiology by the American Board of Internal Medicine (ABIM), and he is an engaged participant in the Maintenance of Certification process.


Before joining the Mayo Clinic, Dr. Friedman worked there as the director of the Cardiac Implantable Device Laboratory. He is a licensed electrical engineer with substantial experience in both scientific research (> 250 original scientific articles) and creativity (> 40 issued patents; dubbed Minnesota's Top Inventor). He has been awarded the title of Minnesota's Top Inventor. In addition to writing over sixty book chapters and serving as the director of five different national and international conferences, he is also the editor of seven different textbooks. He participates in a significant number of educational conferences both as a lecturer and as a visiting professor.