Matthew R. Reynolds

Background: Comparative effectiveness data across ambulatory cardiac monitoring (ACM) modalities are limited. Objective: To confirm and extend comparative findings across ACM modalities and vendors in commercially insured and Medicare Advantage beneficiaries without prior arrhythmia. Methods: Retrospective study using Optum Research Database. Adults ≥ 18 years with first ACM use between January 1, 2017 and June 30, 2022 were categorized as long‐term continuous monitors (LTCM), Holter, external ambulatory event monitors (AEM), or mobile cardiac telemetry (MCT). Outcomes were arrhythmia diagnosis (90 days), repeat monitoring (180 days), cardiovascular events, hospitalization, emergency department [ED] visits, and costs (365 days). Inverse probability of treatment weighting used a specific LTCM (iRhythm Technologies, San Francisco, CA) as reference. Results: Among 352,782 patients (mean age 62.0 ± 17.1 years; 61% female), 25% received LTCM, 37% Holter, 20% AEM, and 18% MCT. Among LTCM users, 58% received iRhythm LTCM. Compared with this LTCM, Holter, MCT, and other LTCM had lower odds of arrhythmia diagnosis (IPTW‐weighted ORs 0.50−0.95; p < 0.01); AEM did not differ. Repeat monitoring was higher for other LTCM, AEM, and Holter (IPTW‐weighted ORs 1.99−2.77; p < 0.001); MCT did not differ. All other modalities had higher IPTW‐weighted odds of cardiovascular events (ORs 1.10−1.66; p < 0.001), hospitalization (ORs 1.12−2.04; p < 0.001), ED visits (ORs 1.09−2.08; p < 0.001), and costs (IPTW‐weighted cost ratios 1.03−1.28; p < 0.01). Conclusions: Outcomes differed across ACM modalities and vendors, confirming observations in other payer populations. A specific LTCM was associated with higher claims‐based arrhythmia yield and lower repeat monitoring than most alternatives, and with lower hospitalization, health care utilization, and costs.

The aim of the AFA-ARC (Atrial Fibrillation Ablation Academic Research Consortium) initiative is to reexamine trial design and the safety and effectiveness end points for pivotal clinical trials evaluating catheter ablation for the treatment of symptomatic atrial fibrillation to provide meaningful and interpretable data to support regulatory decision-making. Beginning in July 2024, a group of international experts began meeting regularly both virtually together and separately in working groups (group 1 effectiveness end points; group 2 safety end points; and group 3 trial design and report forms), with one in-person meeting held in April 2025, and revisions of draft proposals from January 2025 to February 2026. The Food and Drug Administration Office of Cardiovascular Devices at the Center for Devices and Radiological Health provided input throughout the revision and proposal process. A patient advocate participated in the in-person meeting and during the revision phase. Heart Rhythm Society leadership was involved throughout the process and in the revision phase. Industry representatives were sent drafts of the proposed manuscripts during the revision phase before submission. The result of this process was the creation of a combined document to reexamine trial design and the safety and effectiveness end points for pivotal clinical trials evaluating catheter ablation of atrial fibrillation. This document represents contributions from each of the 3 Working Groups. The Heart Rhythm Society endorsed this document. This AFA-ARC document proposes revised effectiveness and safety end points, study design, and report forms for studies evaluating AF ablation in patients with symptomatic paroxysmal, persistent, or longstanding persistent AF.

Background: Use of pulmonary vein isolation (PVI) to treat atrial fibrillation continues to increase. Despite great interest in leveraging administrative data for real‐world analyses, contemporary procedural codes for identifying PVI have not been evaluated. Methods and Results: In this observational retrospective cohort study, inpatient PVIs were identified among US Medicare fee‐for‐service beneficiaries using Current Procedural Terminology (CPT) code 93656 in Carrier Line Files. Each patient was matched with their claims from Medicare Provider Analysis and Review to compare CPT with International Classification of Diseases , Tenth Revision , Procedure Coding System ( ICD‐10‐PCS ) claims submitted by health care facilities to bill for PVIs. We performed the reverse for commonly matched ICD‐10‐PCS codes, to identify corresponding CPT‐billed procedures. Finally, we reviewed institutional cases for additional comparison of CPT and ICD‐10‐PCS assignation for PVI. We identified 25 617 inpatient PVIs from January 2017 to December 2021, of which 18 165 (71%) were linked to Medicare Provider Analysis and Review. Of these, 16 672 (92%) were billed as ICD‐10‐PCS 02583ZZ: “Destruction of Conduction Mechanism, Percutaneous Approach.” The reverse process yielded heterogeneous results: among 75 003 procedures billed as ICD‐10‐PCS 02583ZZ, only 15 691 (21%) matched with CPT 93656 (PVI), as several other unrelated procedures were billed under this ICD‐10‐PCS code. Institutional case review confirmed the greater specificity of CPT codes. Conclusions: The ICD‐10‐PCS code associated with CPT‐billed PVI procedures actually referred to ablation of the atrioventricular junction. Yet this ICD‐10‐PCS code also matched with a wide range of other procedures distinct from PVI. We conclude that ICD‐10‐PCS codes alone are not sensitive nor specific for identifying PVI in claims and cannot be reliably used in isolation for health services research on this important procedure.

BACKGROUND: Long-term outcomes following left atrial appendage occlusion outside clinical trials and small registries are largely unknown. Collecting these data was a condition of US market authorization of the WATCHMAN device. The aim of this analysis was to evaluate the rates of stroke, bleeding, and death among Medicare beneficiaries following left atrial appendage occlusion implantation during initial commercial availability of the WATCHMAN left atrial appendage occlusion device overall and in important subgroups. METHODS: All Medicare fee-for-service beneficiaries ≥65 years of age who underwent left atrial appendage occlusion from April 1, 2016, to August 31, 2020, were included based on the International Classification of Diseases, Tenth Revision , and Current Procedural Terminology codes. Over a 5-year follow-up period, the cumulative incidence over time of mortality, ischemic stroke, and major bleeding were calculated using the International Classification of Diseases, Tenth Revision , diagnosis codes for the full study cohort and within important prespecified subgroups. RESULTS: WATCHMAN recipients (n=48 763) were a median of 77 (interquartile range, 72–82) years of age, 42% female, and mostly White (93%). The median CHA ₂ DS ₂ VASc score was 4 (interquartile range, 3–5) with prior major bleeding in 42% and prior stroke in 12%. At 5 years, death occurred in 44%, bleeding in 15% (with higher risk early following implantation), and ischemic stroke in 7%. Each of these end points was more common with greater baseline age. Male patients had greater 5-year mortality than female patients (46.9% versus 40.6%), but there was no difference between sexes in the rates of ischemic stroke (6.6% versus 7.5%) or major bleeding (14.9% for both). WATCHMAN recipients with prior ischemic stroke or a major bleeding event were older and frailer; these groups had higher rates of ischemic stroke, major bleeding, and death. CONCLUSIONS: Compared with patients enrolled in the pivotal clinical trials, Medicare beneficiaries undergoing WATCHMAN implantation were older, more female, and had more comorbid conditions. Substantial long-term mortality and major bleeding following WATCHMAN reflect the high-risk nature of the patient population, while the ischemic stroke rate was relatively low (<1.5% per year).

Introduction: In hypertrophic cardiomyopathy (HCM), atrial fibrillation (AF) has historically been regarded to have a deleterious impact on clinical course, strongly associated with progressive heart failure (HF) symptoms. However, there is a paucity of information regarding the impact of AF on HCM employing validated quality of life (QoL) surveys. Therefore, we evaluated the impact of AF on QoL utilizing patient reported outcome measures (PROMs).Methods: 218 consecutive HCM patients with or without AF at the Lahey HCM center in 2022 completed PROMs at their most recent visit evaluating HF (Kansas City Cardiomyopathy Questionnaire [KCCQ]) and AF symptoms (AF Effect on QoL [AFEQT]).Results: Among the 218 patients, 50 (23%) had a history of AF and comprise the primary study cohort. AF was diagnosed at 55 ± 10 years of age, median of 5.5 years before PROM, with 66% of patients treated with a rhythm control strategy with antiarrhythmic drug and/or AF ablation. AFEQT indicated that 52% of patients experienced no or minimal AF‐related disability, mild to moderate in 22%, and severe in 26%. There was no substantial difference in HCM phenotype in patients with no or minimal AF disability compared to those with severe disability.HF symptoms for most HCM patients with prior AF history was consistent with no or minimal (59%) or only mild (27%) disability as measured by KCCQ overall summary scores. In addition, with multivariate analysis, AF history was associated with less HF symptoms and improved QoL (OR 0.4, p = 0.02).Conclusion: In contrast to prior perceptions, HCM patients with prior AF history were less likely to incur HF symptoms impairing QoL compared to HCM patients without AF. After treatment, prior history of AF did not substantially impact current QoL. These data provide a realistic appraisal for the impact that AF has on HCM patients and also offers a measure of reassurance for this patient subgroup.

BACKGROUND: The mSToPS study (mHealth Screening to Prevent Strokes) reported screening older Americans at risk for atrial fibrillation (AF) and stroke using 2-week patch monitors was associated with increased rates of AF diagnosis and anticoagulant prescription within 1 year and improved clinical outcomes at 3 years relative to matched controls. Cost-effectiveness of this AF screening approach has not been explored. METHODS: We conducted a US-based health economic analysis of AF screening using patient-level data from mSToPS. Clinical outcomes, resource use, and costs were obtained through 3 years using claims data. Individual costs, survival, and quality-adjusted life years (QALYs) were projected over a lifetime horizon using regression modeling, US life tables, and external data where needed. Adjustment between groups was performed using propensity score bin bootstrapping. RESULTS: Screening participants (mean age, 74 years, 41% female, median CHA ₂ DS ₂ -VASC score 3) wore on average 1.7 two-week monitors at a mean cost of $614/person. Over 3 years, outpatient visits were more frequent for monitored than unmonitored individuals (difference 190 per 100 patient-years [95% CI, 82–298]), but emergency department visits (−8.3 [95% CI, −12.6 to −4.1]) and hospitalizations (−15.2 [CI, −22 to −8.6]) were less frequent. Total adjusted 3-year costs were slightly higher (mean difference, $1551 [95% CI, −$1047 to $4038]) in the monitoring group. In patient-level projections, the monitoring group had slightly greater quality-adjusted survival (8.81 versus 8.71 QALYs, difference, 0.09 [95% CI, −0.05 to 0.24]) and slightly higher lifetime costs, resulting in an incremental cost-effectiveness ratio of $36 100/QALY gained. With bootstrap resampling, the incremental cost-effectiveness ratio for monitoring was <$50 000/QALY in 64% of study replicates, and <$150 000/QALY in 91%. CONCLUSIONS: Using lifetime projections derived from the mSToPS study, we found that AF screening using 2-week patch monitors in older Americans was associated with high economic value. Confirmation of these uncertain findings in a randomized trial is warranted. REGISTRATION: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT02506244.