Commentary
The Food and Drug Administration cleared an algorithm for use by patients on a device that attaches to a smartphone to screen for atrial fibrillation instantly.
The AliveCor Heart Monitor attaches to the back of iPhones or Android-based smartphones. Users place fingers on the device and see information on the phone’s screen. They can log their symptoms, and the ECG reading is sent to the company’s server, so data can be accessed later.
The FDA approved the AliveCor Heart Monitor in 2013, and patients have used it since March 2014, with the device sending the ECG reading to a cardiologist or cardiac technician who would send a reply within 24 hours. In August 2014, the FDA cleared an algorithm to be used in a new, free app on the device that allows patients to get an immediate result showing whether or not they are likely to have atrial fibrillation. The company launched the app on the marketplace at the Health 2.0 fall conference in Santa Clara, Calif.
Validation trials have shown that the single-lead AliveCor Heart Monitor system is comparable to a conventional 12-lead ECG, Dr. Omar Dawood said in an interview at the conference. He is a clinical adviser to AliveCor, a surgeon by training who now works with technology companies. And results of two small Australian trials in clinical settings suggest that the AliveCor system is easily used on patients by pharmacists or nurses and is cost-effective.
In one study, pharmacists screened 1,000 pharmacy customers aged 65 years or older using the AliveCor system. A cardiologist read the results, and patients with suspected new atrial fibrillation were referred to general practitioners for conventional 12-lead ECG.
The AliveCor screening identified new cases of atrial fibrillation in 1.5% of patients and a 6.7% prevalence of atrial fibrillation in the cohort. The automated AliveCor algorithm was 98.5% sensitive and 91.4% specific for atrial fibrillation, reported Nicole Lowres of the University of Sydney, and her associates (Thromb. Haemost. 2014;111:1167-76). The investigators also estimated the incremental cost-effectiveness if AliveCor screening were extended into the community, with some patients receiving prescriptions for warfarin and 55% of those adhering to the medication regimen. They calculated a cost in U.S. dollars of $4,066 per quality-adjusted life-year gained and $20,695 to prevent one stroke.
Screening with the AliveCor Heart Monitor “in pharmacies with an automated algorithm is both feasible and cost-effective,” the investigators concluded.
In a separate pilot study, 88 patients seen in three general practices in Sydney were screened by a receptionist or a nurse using AliveCor before seeing the physician. The AliveCor results were transmitted to a secure website where the physician could see them during the patient’s consultation during the same visit.
The device found active atrial fibrillation in 17 patients (19%), all previously diagnosed. The general practitioners and nurses liked the system and its immediate results, but the receptionists felt uneasy doing the screening, reported Jessica Orchard, also of the university, and her associates.
“Atrial fibrillation screening in general practice is feasible,” the investigators concluded (Aust. Fam. Physician 2014;43:315-9). The AliveCor sells for $60-$199, depending on the model of smartphone.
For more on AliveCor, see our video interview with Dr. Dawood at the Health 2.0 fall conference.
AliveCor provided free devices for the studies, which were funded by scholarships from the National Heart Foundation of Australia. The investigators reported having no other financial associations with AliveCor. Some reported financial associations with BMS/Pfizer, Boehringer Ingelheim, Bayer, Servier, and AstraZeneca.
On Twitter @sherryboschert