The SMART Registry study evaluated the safety and clinical value associated with a next-generation insertable cardiac monitor (ICM)—Confirm Rx™—featuring a new remote monitoring system based on smartphone patient applications. Confirm Rx demonstrated a high safety profile, with a 99.4% rate of freedom from serious adverse events within the first month. It effectively identified true cardiac arrhythmias in 45.7% of patients, leading to significant clinical actions such as pacemaker implants in 8.9% of syncope cases and anticoagulation therapy in 15.7% of cryptogenic stroke cases after arrhythmia detection. The remote monitoring system also received a high approval rate, with 78.2% of patients satisfied with the smartphone application.

In this U.S. nationwide study, real-world clinical evidence was used to compare atrial fibrillation (AF) detection and oral anticoagulant (OAC) initiation in older patients with ischemic stroke using Abbott insertable cardiac monitors (ICMs) versus external cardiac monitors (ECMs). The use of ICMs was associated with nearly three times higher AF detection and OAC implementation compared to ECMs. Furthermore, ICM patients demonstrated less mortality compared to ECM patients at two years, indicating a potential survival benefit of the ICM through more frequent and timely AF diagnosis and OAC adoption.

The real-world performance of SharpSense™ technology in Abbott Confirm Rx™ insertable cardiac monitors (ICMs) was evaluated, revealing substantial improvements. The SharpSense upgrade significantly reduced false positive Bradycardia detections by 91.5% and Pause detections by 82.8%, leading to a notable decrease in the number of unnecessary clinic reviews and enhancing overall device accuracy.

With consistent R-wave amplitude (RWA) being essential for optimal arrhythmia detection, this study assessed RWA variations in 90 participants with Confirm Rx™ ICMs across different postures and activities at insertion and after 30 days. RWA reductions were seen in non-supine positions at insertion, especially in females. The mean RWAs were higher at 30 days with less interparticipant and interpostural variability.

The study evaluated the long-term incidence of nonsustained ventricular tachycardia (NSVT) in low or moderate risk hypertrophic cardiomyopathy (HCM) patients using Abbott ICMs with Bluetooth^®-enabled communication. The results show that prolonged ICM monitoring identified more NSVT episodes compared to standard Holter monitoring, significantly impacting sudden cardiac death (SCD) risk stratification and patient management.

Real world evidence for a cohort of 5,666 American patients who received the Confirm Rx ICM. In total, 97% registered their patient app and 92% transmitted data at least once, demonstrating excellent compliance with the smartphone-based remote monitoring paradigm pioneered by Abbott. Connectivity occurred every 1.5 days, with patient-reported symptoms transmitted to the monitoring system within 2.9 minutes and viewed by clinicians within 0.9 days. The results suggest the suitability of Bluetooth® technology for future cardiac implantable devices.

Implantable cardiac monitors (ICMs) are widely used for arrhythmia detection, yet their data transmission time and accuracy vary. This study compared the Reveal LINQ^‡ with TruRhythm^‡ Detection to the Confirm Rx ICM with SharpSense™ technology. The Confirm Rx demonstrated significantly faster transmission times for all events and patient-activated triggers, with more frequent event detections. It also identified true arrhythmic episodes faster and diagnosed a higher percentage of patients within six months. 

Guidelines recommend implantable loop recorders (ILRs) for evaluating recurrent unexplained syncope in low-risk patients and high-risk patients after a negative evaluation. This systematic review analyzed the diagnostic yield of ILRs in such cases. Across 49 studies with 4,381 subjects, about half of unexplained syncope subjects implanted with an ILR were diagnosed and around 50% of them had an arrhythmia, demonstrating the value of ILRs as a diagnostic tool.

The DETECT AF study evaluated the accuracy in detecting atrial fibrillation (AF) of the Confirm Rx™ predecessor, SJM Confirm™ DM2102 Implantable Cardiac Monitor (ICM). Patients with suspected or known paroxysmal AF were monitored with Holter devices and the ICM to evaluate device sensitivityAbbott’s first ICM notably demonstrated AF patient 100% sensitivity andconcluded that the first ICM accurately and reliably detects AF episodes.

Current guidelines recommend at least 24 hours of ECG monitoring after an ischemic stroke to rule out atrial fibrillation (AF), but the optimal duration and method are unclear. This randomized study compared long-term monitoring with an insertable cardiac monitor (ICM) to conventional follow-up for detecting AF in cryptogenic stroke patients. At six months, AF was detected in 8.9% of the ICM group versus 1.4% of the control group. By 12 months, detection rates were 12.4% for the ICM group and 2.0% for the control group, showing ICMs are more effective for detecting AF post-cryptogenic stroke.