Continuous long-term monitoring of atrial fibrillation (AF) and tachycardia (AT) is an unmet clinical need, which could be met with a chronically-implanted monitor. Improved therapeutic decisions based on accurate monitoring of parameters, such as daily AF/AT burden (hours/ day) may lead to improvements in clinical outcomes such as reduction in hospitalizations, symptoms, and strokes. This paper describes an AF/AT detector that detects AF as well as AT with an irregular ventricular response, and a supplementary AT detector for AT with more regular ventricular response. Seven databases with significant durations of AF, AT, and sinus rhythm were used to evaluate the performance of the detectors. All patient records with AF (N = 124) were detected by the AF/AT detector to have AF/AT burden with a mean, median, and 75 percentile of absolute error in burden detection of 8.8, 0, and 4 min, respectively. In patients having AF burden (= or > 10 min), the AF/AT detector was found to have burden accuracy within 20% of true burden in 96% of patients. The specificity was 94%, defined as follows: in patient records without AF/AT (N = 174), the percentage with AF/AT burden = or < 10 min in the 24-h recordings. The AF/AT detector underestimatesAT burden, thus degrading performance, in patients with significant amounts of AT with more regular ventricular response. The supplementary AT detector reduces the underestimation of AT while overestimating burden in patients without a significant amount of AT. The detectors described here could be implemented in an implantable monitor for accurate long-term AF/AT monitoring.

Background: Studies of patients with cardiovascular implantable electronic devices show a relationship between atrial fibrillation (AF) duration and stroke risk, although the interaction with CHA 2 DS 2 -VASc score is poorly defined. The objective of this study is to evaluate rates of stroke and systemic embolism (SSE) in patients with cardiovascular implantable electronic devices as a function of both CHA 2 DS 2 -VASc score and AF duration. Methods: Data from the Optum electronic health record deidentified database (2007–2017) were linked to the Medtronic CareLink database of cardiovascular implantable electronic devices capable of continuous AF monitoring. An index date was assigned as the later of either 6 months after device implantation or 1 year after electronic health record data availability. CHA 2 DS 2 -VASc score was assessed using electronic health record data before the index date. Maximum daily AF burden (no AF, 6 minutes–23.5 hours, and >23.5 hours) was assessed over the 6 months before the index date. SSE rates were computed after the index date. Results: Among 21 768 nonanticoagulated patients with cardiovascular implantable electronic devices (age, 68.6±12.7 years; 63% male), both increasing AF duration ( P <0.001) and increasing CHA 2 DS 2 -VASc score ( P <0.001) were significantly associated with annualized risk of SSE. SSE rates were low in patients with a CHA 2 DS 2 -VASc score of 0 to 1 regardless of device-detected AF duration. However, stroke risk crossed an actionable threshold defined as >1%/y in patients with a CHA 2 DS 2 -VASc score of 2 with >23.5 hours of AF, those with a CHA 2 DS 2 -VASc score of 3 to 4 with >6 minutes of AF, and patients with a CHA 2 DS 2 -VASc score ≥5 even with no AF. Conclusions: There is an interaction between AF duration and CHA 2 DS 2 -VASc score that can further risk-stratify patients with AF for SSE and may be useful in guiding anticoagulation therapy.

The new AF detection algorithm in the Reveal LINQ ICM accurately detects the presence or absence of AF. Additionally, it showed high sensitivity in detecting AF duration in patients with a history of intermittent and symptomatic AF.

The relative sensitivity and unexplained detection rate of changes in intrathoracic impedance has not been compared with standard heart failure (HF) monitoring using daily weight changes. The Fluid Accumulation Status Trial (FAST) prospectively followed 156 HF patients with implanted cardioverter-defibrillator or cardiac resynchronization therapy defibrillator devices modified to record daily changes in intrathoracic impedance in a blinded fashion for 537±312 days. Daily impedance changes were used to calculate a fluid index that could be compared with a prespecified threshold. True positives were defined as adjudicated episodes of worsening HF occurring within 30 days of a fluid index above threshold or an acute weight gain. Unexplained detections were defined as threshold crossings or acute weight gains not associated with worsening HF. Impedance measurements were performed on >99% of follow-up days, compared with only 76% of days for weight measurements. Sixty-five HF events occurred during follow-up (0.32/patient-year). Forty HF events were detected by impedance but not weight, whereas 5 were detected by weight but not impedance. Sensitivity was greater (76% vs 23%; P<.0001) and unexplained detection rate was lower (1.9 vs 4.3/patient-year; P<.0001) for intrathoracic impedance monitoring at the threshold of 60Ω days compared with acute weight increases of 3 lbs in 1 day or 5 lbs in 3 days and also over a wide range of fluid index and weight thresholds. The sensitivity and unexplained detection rate of intrathoracic impedance monitoring was superior to that seen for acute weight changes. Intrathoracic impedance monitoring represents a useful adjunctive clinical tool for managing HF in patients with implanted devices.

BackgroundWe developed and validated a heart failure (HF) risk score combining daily measurements of multiple device-derived parameters.MethodsHeart failure patients from clinical studies with implantable devices were used to form two separate data sets. Daily HF scores were estimated by combining changes in intra-thoracic impedance, atrial fibrillation (AF) burden, rapid rate during AF, %CRT pacing, ventricular tachycardia, night heart rate, heart rate variability, and activity using a Bayesian model. Simulated monthly follow-ups consisted of looking back at the maximum daily HF risk score in the preceding 30 days, categorizing the evaluation as high, medium, or low risk, and evaluating the occurrence of HF hospitalizations in the next 30 days. We used an Anderson–Gill model to compare survival free from HF events in the next 30 days based on risk groups.ResultsThe development data set consisted of 921 patients with 9790 patient-months of data and 91 months with HF hospitalizations. The validation data set consisted of 1310 patients with 10 655 patient-months of data and 163 months with HF hospitalizations. In the validation data set, 10% of monthly evaluations in 34% of the patients were in the high-risk group. Monthly diagnostic evaluations in the high-risk group were 10 times (adjusted HR: 10.0; 95% CI: 6.4–15.7, P < 0.001) more likely to have an HF hospitalization (event rate of 6.8%) in the next 30 days compared with monthly evaluations in the low-risk group (event rate of 0.6%).ConclusionAn HF score based on implantable device diagnostics can identify increased risk for HF hospitalization in the next 30 days.