AliveCor recently announced that the FDA has cleared an automated algorithm for identifying atrial fibrillation from their single-lead ECG tracing.
When we reviewed Alivecor’s Heart Monitor last year, we highlighted the need for tools to help patients interpret the data being captured. In the SEARCH-AF trial, the AliveCor Heart Monitor was used to perform community screening for atrial fibrillation. That screening strategy was able to achieve an equivalent screening rate to that seen in programs using both pulse palpation and 12-lead EKG screening.
In the cost-effectiveness analysis included in the study, the investigators identified a cost per quality adjusted life year (QALY) gained well below commonly accepted thresholds. And one of the biggest costs in that screening program was the interpretation of the tracing.
While the actual FDA filing is not available on the publicly available 510(k), they did present validation studies at the AHA and including testing of their algorithm in the SEARCH-AF study. There, the automated algorithm achieved a 98% sensitivity and 91% specificity for the detection of atrial fibrillation.
The inclusion of an automated detection algorithm for atrial fibrillation into a device that can essentially be used by most patients unassisted could not only further lower the cost per screen but also expand the potential reach of screening programs.
Mobile health technology continues to develop at an explosive rate due to distinct advantages over traditional tools; in particular, the generally lower costs, greater mobility, and opportunities for ready integration. With the AliveCor Heart Monitor, we can hopefully expect further evaluation into the effectiveness, costs, and safety particularly when it comes to false positives.