FDA Approved: CardioInsight (ECGI) Mapping and Ablation System Now Available in U.S.
Medtronic’s CardioInsight Noninvasive 3D Mapping System (ECGI) has received FDA clearance for use in the U.S. The CardioInsight system is the first non-invasive mapping system in the world.
Dr. Vivek Reddy at Mount Sinai Medical Center in New York City was the first to use the system commercially in the U.S.
CardioInsight Noninvasive 3D Mapping System (ECGI)
The CardioInsight system allows physicians to locate the origin of a patient’s irregular heart rhythms (arrhythmias). Cardiac mapping is traditionally achieved by inserting a catheter into the heart via an artery or vein.
The CardioInsight 3D system instead uses a 252-electrode sensor vest to non-invasively (from outside the heart) map irregular rhythms like A-Fib. The vest is a single-use, disposable multi-electrode vest that gathers cardiac electrophysiological data from the body surface. The 3D mapping system combines these signals with CT scan data to produce and display simultaneous 3-D cardiac maps.
The vest technology contours to the patient’s body and allows for continuous and simultaneous panoramic mapping of both atria or both ventricles, which cannot be achieved with current invasive methods. The 3D cardiac maps can be created by capturing a single heartbeat, and enable rapid mapping of these heart rhythms.
ECGI is a Major Breakthrough in Treating A-Fib
ECGI mapping is certainly one of, or even the most important new development in the treatment of A-Fib.
In 2013, I started reporting about this ECGI system. Prof. Haissaguerre and his colleagues in Bordeaux, France, were very active and instrumental in the use of the CardioInsight system. They are credited with the greatest number of presentations and publications on the system. CardioInsight expanded its rollout to eight different venues in Europe where it tested as well as it did at Bordeaux. It’s now available in the U.S.―great news for patients.
Back then, I predicted that “the ECGI system, barring unforeseen circumstances, would rapidly supersede all other mapping systems and will become the standard of care in the treatment of A-Fib patients.”
Not only does the CardioInsight (ECGI) system produce a complete, precise, 3D, color video of each spot in a patient’s heart producing A-Fib signals, but also the video can be done by a technician before the procedure right at the patient’s bedside rather than by the electrophysiologist (EP) during an ablation. It also can be used during the procedure, for example to re-map an ablated area.
Dr Vivek Reddy stated: “This system shifts mapping away from the EP lab, potentially saving time and enhancing the patient experience.”
The CardioInsight map is a better, more accurate, more complete map than an EP can produce by using a conventional mapping catheter inside the heart.
Should You Wait on Your Ablation for ECGI Mapping?
From a patient’s perspective, CardioInsight (ECGI) reduces both the time it takes to do an ablation and the number of burns a patient receives.
The question for patients is, should you wait on having an ablation till a CardioInsight mapping system is available at your center?
The CardioInsight mapping system is most effective in cases of persistent or long-standing persistent A-Fib where non-PV triggers have developed. Most cases of short-duration, paroxysmal A-Fib haven’t usually developed a lot of non-PV triggers.
Hence, if you’ve only been in A-Fib for a relatively short time and are still paroxysmal, it’s probably not worth the wait.
Medtronic Rollout of CardioInsight System
Medtronic will employ a strategic rollout of the technology in the geographies where it is cleared. I will try to report when an A-Fib center in the U.S. receives a CardioInsight system..
To read more about the CardioInsight (ECGI) system, see my article, How ECGI (Non-Invasive Electrocardiographic Imaging) Works.
Disclosure: Dr Vivek Reddy consults for and receives research funding from Medtronic.