Forward-solution computational ECG mapping system may enhance arrhythmia therapies
In the VMAP study, a noninvasive forward-solution computational ECG mapping system met accuracy goals for arrhythmia and pacing localization, suggesting a role for its use in targeted arrhythmia therapies, researchers reported.
The researchers conducted the study to determine whether the mapping system (vMap, Vektor Medical), which can rapidly map cardiac arrhythmias using only 12-lead ECG data, would be accurate at identifying arrhythmia sources in the heart.
As Healio previously reported, the system received FDA clearance in November 2021.
“The most common way we map arrhythmias is invasively with multi-electrode catheters,” David E. Krummen, MD, professor of clinical medicine at the University of California, San Diego, and director of electrophysiology at the VA San Diego Healthcare System, told Healio. “The vMap system is completely noninvasive, and essentially the data source for it is the 12-lead electrocardiogram. There are other noninvasive mapping systems available, and these use very innovative and exciting techniques, but what differentiates [vMap] is the data that’s required to form the mapping process. For example, another system requires a mapping vest and a CT scan. Another one uses a 12-lead ECG, but you have to know precisely where the 12-lead ECG electrodes are placed, and also have a CT scan with those electrodes in position. Our system can take any 12-lead ECG data; the methodology is relatively insensitive to the precise positioning of the electrodes, and we can do the mapping system relatively quickly and easily.”
For the VMAP study, the mapping system was compared with the gold standard of invasive electrophysiology study and ablation in 255 episodes from 225 patients (30% aged 60 to 69 years; 61% men).
The primary endpoint was the regional accuracy of the mapping system compared with the electrophysiology study-determined site of origin for premature ventricular complexes and ventricular tachycardia in patients without structural heart disease and ventricular scar burden of less than 10%.
Accuracy demonstrated
Krummen, who is a co-founder of Vektor Medical but does not hold a position at the company, and colleagues found that the primary endpoint, assessed in 75 patients, was 98.7% regional accuracy (95% CI, 96-100; P < .001).
The first secondary endpoint of regional accuracy in all patients was 96.9% (95% CI, 94.7-99; P < .001), according to the researchers.
The second secondary endpoint of accuracy for exact or neighboring segment in all episodes was 97.3% (95% CI, 95.2-99.3; P < .001).
The median spatial accuracy was 15 mm (interquartile range [IQR], 7-25) and the median mapping process time was 0.8 minutes (IQR, 0.4-1.4), Krummen and colleagues found.
“We planned the study to evaluate whether there were particular arrhythmia types that it didn’t do well on, or were there particular subpopulations that it didn’t do well on, and we were happy to see that there weren’t any arrhythmia or pacing types that did worse than others, and there weren’t any patient populations of those who were included in the study that the system didn’t work well with,” Krummen told Healio. “With a median spatial accuracy of 15 mm for all 255 samples in nine different arrhythmia and pacing types, we feel this technology could be generally useful to help guide targeted therapies in the electrophysiology setting. This study provides the impetus to start to look at doing that in a prospective fashion.”
Motivating factors
One of the next steps is to incorporate an incursive learning algorithm for the system to learn from correct and incorrect cases “to really dial in the accuracy,” Krummen told Healio.
“The big motivating factor for inventing this technology was to help make procedures more efficient and possibly more successful, and to use less fluoroscopy,” Krummen told Healio. “In my clinical practice, I see a lot of patients who are reluctant to undergo invasive arrhythmia management. We are trying to improve the safety and possibly help more patients with catheter ablation for conditions such as atrial fibrillation, ventricular tachycardia, premature ventricular complexes and ventricular fibrillation.”
For more information:
David E. Krummen, MD, can be reached at dkrummen@health.ucsd.edu.
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