iRhythm Technologies reports positive results of the Apple Heart Study.

In the Apple Heart Study, which was designed to determine whether the Apple Watch can correctly diagnosis the occurrence of atrial fibrillation (aFib) in over 400,000 users, the Apple Watch alerted just 0.5% of trial participants to the presence of an irregular heartbeat. To confirm the diagnosis, these people were subjected to a week of monitoring using an ECG chest patch like the Zio XT patch from iRhythm Technologies. Of the 2000 people that required monitoring, about one-third were found to actually have aFib.

iRhythm also conducted its own study with 1,738 participants, none of which had a history of aFib. The participants wore the Zio XT patch for an average of nearly 25 days, and aFib was diagnosed in 6.3% of actively monitored participants compared to 2.3% in observational control. Among the newly diagnosed patients, emergency room visits dropped 6.7 to 2.3 per 100 people for those with active monitoring. In addition, in-patient hospitalization decreases from 14.4 to 3.8 per 100. Across all participants, outpatient visits increased from 4.7 to 6.7.

The company noted that routine ECG screening for aFib is currently not recommended due to its unknown impacts on the healthcare system and utilization. These results suggest it could have a positive impact.

There is some concern about the reimbursement model used for the Zio patch, according to analysts. It is currently reimbursed via a temporary CPT, but a permanent code is expected to be established in 2021. As the Zio patch is more widely used, competition is also increasing, which could impact commercial reimbursements.