Core Insights - iRhythm Technologies, Inc. announced positive results from the AMALFI clinical trial, indicating that home-based screening with the Zio long-term continuous monitoring (LTCM) service significantly improved atrial fibrillation (AFib) detection and reduced time to diagnosis [1][5][6] Study Design and Population - The AMALFI trial was a randomized controlled trial involving 5,040 participants aged 65 and older with moderate to high stroke risk, comparing home-based screening using the Zio XT LTCM device to usual care over a follow-up period of 2.5 years [2][5] - Participants were identified through an automated search of electronic health records in 27 primary care practices in the UK, and the study was conducted entirely remotely without physical sites [2][6] Key Findings - The intervention group showed a higher rate of new AFib diagnoses (6.8%) compared to the control group (5.4%), with a statistically significant difference (p=0.03) [3][4] - The median time to diagnosis for the intervention group was 103 days, significantly shorter than the 530 days for the control group [3][4] - Participants in the intervention group had a longer average exposure to oral anticoagulation (1.63 months) compared to the control group (1.14 months), indicating improved treatment initiation [3] Implications for Healthcare - The study supports the feasibility of primary care-initiated, home-based diagnostic monitoring, aligning with the NHS's focus on disease prevention and early detection [4][6] - The findings suggest that the Zio LTCM service can be effectively implemented at scale, enhancing the identification of undiagnosed arrhythmias and enabling timely therapeutic interventions [7][8] Technology and Methodology - The Zio LTCM service utilizes a wearable ECG patch that captures continuous data for up to 14 days, processed by a deep-learned algorithm to detect various arrhythmias [6][7] - The service has been available in the US since 2008 and was introduced in the UK in 2014, demonstrating a commitment to improving patient outcomes through innovative technology [6][14]

Core Insights - The AVALON study published in the American Journal of Managed Care reinforces the clinical superiority of iRhythm Technologies' Zio long-term continuous monitoring (LTCM) service among commercially insured patients, demonstrating its effectiveness compared to other ambulatory cardiac monitoring (ACM) modalities [1][2][3] Study Findings - AVALON is the largest real-world study of its kind, involving 428,707 commercially insured patients, and shows that the Zio LTCM service has the highest diagnostic yield, fastest time to diagnosis, and lowest total healthcare costs compared to other monitoring modalities [4][6][11] - The Zio LTCM service was associated with a 2.04 times higher likelihood of new arrhythmia diagnosis within 90 days compared to Holter monitors, and 1.69 times compared to ambulatory event monitors (AEM) [8][12] - The median time from end-of-wear to arrhythmia diagnosis for the Zio LTCM service was 9 days, significantly faster than Holter (12 days) and AEM (30 days) [12] - The Zio LTCM service demonstrated the lowest total medical and pharmacy costs at $10,476 per patient-year, compared to Holter ($11,042), AEM ($11,492), and non-iRhythm LTCM services ($11,293) [12] Clinical Implications - The findings indicate that the Zio LTCM service leads to lower healthcare resource utilization, including fewer emergency department visits and hospitalizations, and a lower likelihood of cardiovascular events [11][12] - The study confirms that the Zio LTCM service's advantages extend across diverse patient populations and payer segments, building on previous findings from the Medicare-focused CAMELOT study [6][13] Company Commitment - iRhythm Technologies emphasizes its commitment to delivering clinically meaningful innovations that drive value across the healthcare system, as highlighted by the results of the AVALON study [3][10][14]