Impact of frailty in hospitalized patients undergoing catheter ablation for atrial fibrillation.

BACKGROUND: Catheter Ablation (CA) is an effective treatment for atrial fibrillation (AF). However, frail elderly patients have been understudied due to their exclusion from landmark trials. OBJECTIVES: Our study aims to evaluate outcomes in this population. METHODS: The national readmission database (2016-2020) was queried, and frailty categories were defined based on hospital risk frailty scores ≦5 as low while >5 as intermediate/high frailty (IHF). We used multivariate regression and propensity-matched analysis to compare outcomes in patients undergoing CA for atrial fibrillation based on frailty index. RESULTS: Among 55 936 CAs for AF, 33,248 patients had low frailty, while 22 688 had intermediate/high frailty (IHF). After propensity matching (N 12 448), IHF patients were found to have higher adverse events, including mortality (3% vs. 0.3%, p < .001), stroke (1.9% vs. 0.2%, p < .001), acute heart failure (53.8% vs. 42.2%, p < .001), AKI (42.5% vs. 6.8%, p < .001), pericardial complications (2.8 vs. 1.6%, p < .001), respiratory complications (27.8 vs. 7.2%, p < .001), major adverse cardiovascular events (21.2 vs. 9.4%, p < .001) and net adverse events (76.7 vs. 55%, p < .001). IHF patients had higher readmissions at 30 (15.5 vs. 12.6%, p < .001), 90 (31.9 vs. 25.1%, p < .001), and 180-day (41 vs. 34.7%, p < .001) intervals. A higher median length of stay (LOS) (7 vs. 3 days, p < .001) and cost ($44 287 vs. $27 517, p < .001) at index admission and subsequent readmissions were also observed (p < .001). CONCLUSION: Intermediate/high frailty patients undergoing catheter ablation had worse clinical outcomes, higher healthcare burden, and readmission rates. LOS has decreased in both groups from 2016 to 2020; however, total cost has increased.

A danish healthcare-focused economic evaluation of first-line cryoballoon ablation versus antiarrhythmic drug therapy for the treatment of paroxysmal atrial fibrillation.

INTRODUCTION: Three randomised controlled trials (RCTs) have demonstrated that first-line cryoballoon pulmonary vein isolation decreases atrial tachycardia in patients with symptomatic paroxysmal atrial fibrillation (PAF) compared with antiarrhythmic drugs (AADs). The aim of this study was to develop a cost-effectiveness model (CEM) for first-line cryoablation compared with first-line AADs for the treatment of PAF. The model used a Danish healthcare perspective. METHODS: Individual patient-level data from the Cryo-FIRST, STOP AF and EARLY-AF RCTs were used to parameterise the CEM. The model structure consisted of a hybrid decision tree (one-year time horizon) and a Markov model (40-year time horizon, with a three-month cycle length). Health-related quality of life was expressed in quality-adjusted life years (QALYs). Costs and benefits were discounted at 3% per year. Model outcomes were produced using probabilistic sensitivity analysis. RESULTS: First-line cryoablation is dominant, meaning it results in lower costs (-€2,663) and more QALYs (0.18) when compared to first-line AADs. First-line cryoablation also has a 99.96% probability of being cost-effective, at a cost-effectiveness threshold of €23,200 per QALY gained. Regardless of initial treatment, patients were expected to receive ∼ 1.2 ablation procedures over a lifetime horizon. CONCLUSION: First-line cryoablation is both more effective and less costly (i.e. dominant), when compared with AADs for patients with symptomatic PAF in a Danish healthcare system.

Global burden of atrial fibrillation/atrial flutter and its attributable risk factors from 1990 to 2021.

AIMS: To devise effective preventive measures, a profound understanding of the evolving patterns and trends in atrial fibrillation (AF) and atrial flutter (AFL) burdens is pivotal. Our study was designed to quantify the burden and delineate the risk factors associated with AF and AFL across 204 countries and territories spanning 1990-2021. METHODS AND RESULTS: Data pertaining to AF and AFL were sourced from the Global Burden of Disease Study 2021. The burden of AF/AFL was evaluated using metrics such as incidence, disability-adjusted life years (DALYs), deaths, and their corresponding age-standardized rates (ASRs), stratified by age, sex, socio-demographic index (SDI), and human development index (HDI). The estimated annual percentage change was employed to quantify changes in ASRs. Population attributable fractions were calculated to determine the proportional contributions of major risk factors to age-standardized AF/AFL deaths. This analysis encompassed the period from 1990 to 2021. Globally, in 2021, there were 4.48 million incident cases [95% uncertainty interval (UI): 3.61-5.70], 8.36 million DALYs (95% UI: 6.97-10.13) and 0.34 million deaths (95% UI: 0.29-0.37) attributed to AF/AFL. The AF/AFL burden in 2021, as well as its trends from 1990 to 2021, displayed substantial variations based on gender, SDI quintiles, and geographical regions. High systolic blood pressure emerged as the leading contributor to age-standardized AF/AFL incidence, prevalence, death, and DALY rate globally among all potential risk factors, followed closely by high body mass index. CONCLUSION: Our study underscores the enduring significance of AF/AFL as a prominent public health concern worldwide, marked by profound regional and national variations. Despite the substantial potential for prevention and management of AF/AFL, there is a pressing imperative to adopt more cost-effective strategies and interventions to target modifiable risk factors, particularly in areas where the burden of AF/AFL is high or escalating.

A cost-consequence analysis comparing three cardiac ablation strategies for the treatment of paroxysmal atrial fibrillation.

BACKGROUND AND AIMS: Cardiac ablation is a well-established method for treating atrial fibrillation (AF). Pulsed field ablation (PFA) is a non-thermal therapeutic alternative to radiofrequency ablation (RFA) and cryoballoon ablation (CRYO). PFA uses high-voltage electric pulses to target cells. The present analysis aims to quantify the costs, outcomes, and resources associated with these three ablation strategies for paroxysmal AF. METHODS: Real-world clinical data were prospectively collected during index hospitalization by three European medical centers (Belgium, Germany, the Netherlands) specialized in cardiac ablation. These data included procedure times (pre-procedural, skin-to-skin and post-procedural), resource use, and staff burden. Data regarding complications associated with each of the three treatment options and redo procedures were extracted from the literature. Costs were collected from hospital economic formularies and published cost databases. A cost-consequence model from the hospital perspective was built to estimate the impact of the three treatment options in terms of effectiveness and costs. RESULTS: Across the three centers, N = 91 patients were included over a period of 12 months. A significant difference was seen in pre-procedural time (mean ± SD, PFA: 13.6 ± 3.7 min, CRYO: 18.8 ± 6.6 min, RFA: 20.4 ± 6.4 min; p < .001). Procedural time (skin-to-skin) was also different across alternatives (PFA: 50.9 ± 22.4 min, CRYO: 74.5 ± 24.5 min, RFA: 140.2 ± 82.4 min; p < .0001). The model reported an overall cost of €216,535 per 100 patients treated with PFA, €301,510 per 100 patients treated with CRYO and €346,594 per 100 patients treated with RFA. Overall, the cumulative savings associated with PFA (excluding kit costs) were €850 and €1,301 per patient compared to CRYO and RFA, respectively. CONCLUSION: PFA demonstrated shorter procedure time compared to CRYO and RFA. Model estimates indicate that these time savings result in cost savings for hospitals and reduce outlay on redo procedures. Clinical practice in individual hospitals varies and may impact the ability to transfer the results of this analysis to other settings.

Employing Real-World Evidence for the Economic Evaluation of Non-Vitamin K Antagonist Oral Anticoagulants in Patients with Atrial Fibrillation in Thailand.

BACKGROUND: This study aimed to assess the cost-effectiveness of non-vitamin K antagonist oral anticoagulants (NOACs) in comparison with warfarin using data from real practice based on the perspective of the health care system in Thailand. METHODS: A four-state Markov model encompassing well-controlled atrial fibrillation (AF), stroke and systemic embolism, major bleeding and death was utilised to forecast clinical and economic outcomes. Transitional probabilities, direct medical costs and utilities were derived from the real-world data of the 'COOL-AF Thailand' registry, Thailand's largest nationwide registry spanning 27 hospitals. The cohort comprised AF patients. The primary outcomes assessed were total costs, life years, quality-adjusted life years (QALYs) and the incremental cost-effectiveness ratio. All costs and outcomes were subject to an annual discount rate of 3.0%. A spectrum of sensitivity analyses was conducted. RESULTS: The mean age of the cohort was 68.8 ± 10.7 years. The NOACs group incurred a marginally lower total lifetime cost than the warfarin group (247,857 Thai baht [THB] vs 253,654 THB or 7137 USD vs 7304 USD) and experienced gains of 0.045 life years and 0.043 QALYs over the warfarin group. Given the lower cost and higher benefits associated with NOACs, this implies that NOAC treatment is a dominant strategy compared to warfarin for AF patients. At a ceiling ratio of 160,000 THB (4607 USD) per QALY, NOACs presented a 61.2% probability of being cost effective. CONCLUSIONS: Non-vitamin K antagonist oral anticoagulants represent a cost-saving alternative to warfarin in the real clinical practice. However, with a probability of being cost effective below 65%, it suggests some parameter uncertainty regarding their overall cost effectiveness compared to warfarin.

Comprehensive analysis of same day discharge after atrial fibrillation ablation: Clinical, cost, and patient reported outcomes.

BACKGROUND: Same day discharge (SDD) following atrial fibrillation (AF) ablation procedure has emerged as routine practice, and primarily driven by operator discretion. However, the impacts of SDD on clinical outcomes, healthcare system costs, and patient reported outcomes (PROs) have not been systematically studied. METHODS: We retrospectively analyzed patients undergoing routine AF ablation procedures with SDD versus overnight observation (NSDD). After propensity adjustment we compared postprocedure adverse events (AEs), healthcare system costs, and changes in PROs. RESULTS: We identified 310 cases, with 159 undergoing SDD and 151 staying at least one midnight in the hospital (NSDD). Compared with NSDD, SDD patients were similar age (mean 64 vs. 66, p = 0.3), sex (26% female vs. 27%, p = 0.8), and with lower mean CHADS2-VA2Sc scores (2.0 vs. 2.7; p < 0.011). The primary outcome of AEs was noninferior in SDD versus NSDD patients (odds ratio 0.45, 95% confidence interval 0.21-0.99; noninferiority margin of 10%). There were also no differences in overall cost to the healthcare system between SDD and NSDD (p = 0.11). PROs numerically favored SDD (p = NS for all scores). CONCLUSIONS: Physician selection for SDD appears at least as safe as NSDD with respect to clinical outcomes and SDD is not significantly less costly to the health system. There is a trend towards more favorable, general PROs among SDD patients. Routine SDD should be strongly considered for patients undergoing routine AF ablation procedures.

Cost-Effectiveness and Budget Impact Analysis of Apixaban and Rivaroxaban Versus Warfarin in the Prevention of Stroke in Patients With Non-Valvular Atrial Fibrillation (NVAF) in Iran.

INTRODUCTION: This study evaluates the cost-effectiveness of Apixaban and Rivaroxaban, compared to Warfarin, for stroke prevention in patients with non-valvular atrial fibrillation in Iran. METHOD: A Markov model with a 30-year time horizon was employed to simulate and assess different treatment strategies' cost-effectiveness. The study population comprised Iranian adults with NVAF, identified through specialist consultations, hospital visits, and archival record reviews. Direct medical costs, direct nonmedical, and indirect costs were included. Quality-adjusted life years (QALY) were assessed using an EQ-5D questionnaire. This study utilized a cost-effectiveness threshold of $11 134 per QALY. RESULTS: Apixaban demonstrated superior cost-effectiveness compared to Rivaroxaban and Warfarin. Over 30 years, total costs were lower in the Apixaban and Rivaroxaban groups compared to the Warfarin group ($126.18 and $109.99 vs. $150.49). However, Apixaban showed higher total QALYs gained compared to others (0.134 vs. 0.133 and 0.116). The incremental cost-effectiveness ratio for comparing Apixaban to Warfarin was calculated at -1332.83 cost per QALY, below the threshold of $11 134, indicating Apixaban's cost-effectiveness. Sensitivity analyses confirmed the robustness of the findings, with ICER consistently remaining below the threshold. Over 5 years (2024-2028) of Apixaban usage, the incremental cost starts at USD 70 250 296 in the first year and gradually rises to USD 71 770 662 in the fifth year. DSA and PSA were assessed to prove the robustness of the results. CONCLUSION: This study shows that Apixaban is a cost-effective option for stroke prevention in non-valvular atrial fibrillation patients in Iran compared to Warfarin.

Long-term clinical outcomes and cost-effectiveness of catheter vs thoracoscopic surgical ablation in long-standing persistent atrial fibrillation using continuous cardiac monitoring: CASA-AF randomized controlled trial.

BACKGROUND: Long-term clinical outcomes of catheter ablation (CA) compared to thoracoscopic surgical ablation (SA) to treat patients with long-standing persistent atrial fibrillation (LSPAF) are not known. OBJECTIVE: The purpose of this study was to compare the long-term (36-month) clinical efficacy, quality of life, and cost-effectiveness of SA and CA in LSPAF. METHODS: Participants were followed up for 3 years using implantable loop recorders and questionnaires to assess the change in quality of life. Intention-to-treat analyses were used to report the findings. RESULTS: Of the 115 patients with LSPAF treated, 104 (90.4%) completed 36-month follow-up [CA: n = 57 (95%); SA: n = 47 (85%)]. After a single procedure without antiarrhythmic drugs, 7 patients (12%) in the CA arm and 5 (11%) in the SA arm [hazard ratio 1.22; 95% confidence interval (CI) 0.81-1.83; P = .41] were free from atrial fibrillation/tachycardia (AF/AT) ≥30 seconds at 36 months. Thirty-three patients (58%) in the CA arm and 26 (55%) in the SA arm (hazard ratio 1.04; 95% CI 0.57-1.88; P = .91) had their AF/AT burden reduced by ≥75%. The overall impact on health-related quality of life was similar, with mean quality-adjusted life year estimates of 2.45 (95% CI 2.31-2.59) for CA and 2.32 (95% CI 2.13-2.52) for SA. Estimated costs were higher for SA (mean £24,682; 95% CI £21,746-£27,618) than for CA (mean £18,002; 95% CI £15,422-£20,581). CONCLUSION: In symptomatic LSPAF, CA and SA were equally effective at achieving arrhythmia outcomes (freedom from AF/AT ≥30 seconds and ≥75% burden reduction) after a single procedure without antiarrhythmic drugs. However, SA is significantly more costly than CA.

Cost, efficiency, and outcomes of pulsed field ablation vs thermal ablation for atrial fibrillation: A real-world study.

BACKGROUND: With the exponential growth of catheter ablation for atrial fibrillation (AF), there is increasing interest in associated health care costs. Pulsed field ablation (PFA) using a single-shot pentaspline multielectrode catheter has been shown to be safe and effective for AF ablation, but its cost efficiency compared to conventional thermal ablation modalities (cryoballoon [CB] or radiofrequency [RF]) has not been evaluated. OBJECTIVE: The purpose of this study was to compare cost, efficiency, effectiveness, and safety between PFA, CB, and RF for AF ablation. METHODS: We studied 707 consecutive patients (PFA: 208 [46.0%]; CB: 325 [29.4%]; RF: 174 [24.6%]) undergoing first-time AF ablation. Individual procedural costs were calculated, including equipment, laboratory use, and hospital stay, and compared between ablation modalities, as were effectiveness and safety. RESULTS: Skin-to-skin times and catheter laboratory times were significantly shorter with PFA (68 and 102 minutes, respectively) than with CB (91 and 122 minutes) and RF (89 and 123 minutes) (P < .001). General anesthesia use differed across modalities (PFA 100%; CB 10.2%; RF 61.5%) (P < .001). Major complications occurred in 1% of cases, with no significant differences between modalities. Shorter procedural times resulted in lower staffing and laboratory costs with PFA, but these savings were offset by substantially higher equipment costs, resulting in higher overall median costs with PFA (£10,010) than with CB (£8106) and RF (£8949) (P < .001). CONCLUSION: In this contemporary real-world study of the 3 major AF ablation modalities used concurrently, PFA had shorter skin-to-skin and catheter laboratory times than did CB and RF, with similarly low rates of complications. However, PFA procedures were considerably more expensive, largely because of higher equipment cost.

Health-related quality of life and healthcare costs of symptoms and cardiovascular disease events in patients with atrial fibrillation: a longitudinal analysis of 27 countries from the EURObservational Research Programme on Atrial Fibrillation general long-term registry.

AIMS: We examine the effects of symptoms and cardiovascular disease (CVD) events on health-related quality of life (HRQOL) and healthcare costs in a European population with atrial fibrillation (AF). METHODS AND RESULTS: In the EURObservational Research Programme on AF long-term general registry, AF patients from 250 centres in 27 European countries were enrolled and followed for 2 years. We used fixed effects models to estimate the association of symptoms and CVD events on HRQOL and annual healthcare costs. We found significant decrements in HRQOL in AF patients in whom ST-segment elevation myocardial infarction (STEMI) [-0.075 (95% confidence interval -0.144, -0.006)], angina or non-ST-elevation myocardial infarction (NSTEMI) [-0.037 (-0.071, -0.003)], new-onset/worsening heart failure [-0.064 (-0.088, -0.039)], bleeding events [-0.031 (-0.059, -0.003)], thromboembolic events [-0.071 (-0.115, -0.027)], mild symptoms [0.037 (-0.048, -0.026)], or severe/disabling symptoms [-0.090 (-0.108, -0.072)] occurred during the follow-up. During follow-up, annual healthcare costs were associated with an increase of €11 718 (€8497, €14 939) in patients with STEMI, €5823 (€4757, €6889) in patients with angina/NSTEMI, €3689 (€3219, €4158) in patients with new-onset or worsening heart failure, €3792 (€3315, €4270) in patients with bleeding events, and €3182 (€2483, €3881) in patients with thromboembolic events, compared with AF patients without these events. Healthcare costs were primarily driven by inpatient costs. There were no significant differences in HRQOL or healthcare resource use between EU regions or by sex. CONCLUSION: Symptoms and CVD events are associated with a high burden on AF patients and healthcare systems throughout Europe.

Association Between Sleep Apnea Treatment and Health Care Resource Use in Patients With Atrial Fibrillation.

BACKGROUND: Obstructive sleep apnea (OSA) contributes to the generation, recurrence, and perpetuation of atrial fibrillation, and it is associated with worse outcomes. Little is known about the economic impact of OSA therapy in atrial fibrillation. This retrospective cohort study assessed the impact of positive airway pressure (PAP) therapy adherence on health care resource use and costs in patients with OSA and atrial fibrillation. METHODS AND RESULTS: Insurance claims data for ≥1 year before sleep testing and 2 years after device setup were linked with objective PAP therapy use data. PAP adherence was defined from an extension of the US Medicare 90-day definition. Inverse probability of treatment weighting was used to create covariate-balanced PAP adherence groups to mitigate confounding. Of 5867 patients (32% women; mean age, 62.7 years), 41% were adherent, 38% were intermediate, and 21% were nonadherent. Mean±SD number of all-cause emergency department visits (0.61±1.21 versus 0.77±1.55 [P=0.023] versus 0.95±1.90 [P<0.001]), all-cause hospitalizations (0.19±0.69 versus 0.24±0.72 [P=0.002] versus 0.34±1.16 [P<0.001]), and cardiac-related hospitalizations (0.06±0.26 versus 0.09±0.41 [P=0.023] versus 0.10±0.44 [P=0.004]) were significantly lower in adherent versus intermediate and nonadherent patients, as were all-cause inpatient costs ($2200±$8054 versus $3274±$12 065 [P=0.002] versus $4483±$16 499 [P<0.001]). All-cause emergency department costs were significantly lower in adherent and intermediate versus nonadherent patients ($499±$1229 and $563±$1292 versus $691±$1652 [P<0.001 and P=0.002], respectively). CONCLUSIONS: These data suggest clinical and economic benefits of PAP therapy in patients with concomitant OSA and atrial fibrillation. This supports the value of diagnosing and managing OSA and highlights the need for strategies to enhance PAP adherence in this population.

Cost-effectiveness of left atrial appendage occlusion during cardiac surgery in France: An economic evaluation based on the LAAOS III study.

OBJECTIVES: Left atrial appendage occlusion during cardiac surgery is a therapeutic option for stroke prevention in patients with atrial fibrillation. The effectiveness and safety of left atrial appendage occlusion have been evaluated in several studies, including the LAAOS-III trial. While these studies have demonstrated efficacy and safety, the long-term economic impact of this surgical technique has not yet been assessed. Here, we aimed to evaluate the cost-effectiveness and cost-utility of left atrial appendage occlusion during cardiac surgery over a long-term time horizon. METHODS: Our study was based on a model representing an hypothetical cohort with the same characteristics as LAAOS-III trial patients. We modelled the incidence of ischemic strokes and systemic embolisms in each intervention arm: "occlusion" and "no-occlusion," using a one-month cycle length with a 20-year time horizon. Regarding occlusion devices, sutures, staples, or an approved surgical occlusion device (AtriClip™-AtriCure, Ohio, USA) could be used. RESULTS: Our model generated an average cost savings of 607 euros per patient and an incremental gain of 0.062 quality-adjusted life years (QALYs), resulting an incremental cost-utility ratio (ICUR) of €-9,775/QALY. The scenario analysis in which occlusion was systematically performed using the AtriClip™ device generated an ICUR of €3,952/QALY gained. CONCLUSIONS: In the base-case analysis, the strategy proved to be more effective and less costly, confirming left atrial appendage occlusion during cardiac surgery as an economically dominant strategy. The scenario analysis also appeared cost-effective, although it did not result in cost savings. This study provides a new perspective on the assessment of the cost-effectiveness of these techniques.

Pulsed field ablation with the pentaspline catheter compared with cryoablation for the treatment of paroxysmal atrial fibrillation in the UK NHS: a cost-comparison analysis.

OBJECTIVES: Pulsed field ablation (PFA) is a promising new ablation modality for the treatment of atrial fibrillation (AF) that has recently become available in the UK National Health Service (NHS). We provide the first known economic evaluation of the technology. METHODS: A cost-comparison model was developed to compare the expected 12-month costs of treating AF using the pentaspline PFA catheter compared with cryoablation for a single hypothetical patient. Model parameters were based on a recent cost-effectiveness analysis by the National Institute for Health and Care Excellence where possible or published literature otherwise. Deterministic sensitivity, scenario and threshold analyses were conducted. RESULTS: Costs for a single patient treated with PFA were -3% (-£343) less over 12 months than those who received treatment with cryoablation. PFA was associated with 16% higher catheter costs but repeat ablation costs were over 50% less, driven by a reduction in repeat ablations required. Costs of managing complications were -£211 less in total for PFA compared with cryoablation. CONCLUSIONS: Routine adoption of PFA with the pentaspline PFA catheter looks to be as affordable for the NHS as current treatment alternative cryoablation.

Epidemiology and comprehensive economic impact of atrial fibrillation and associated stroke in Slovakia.

BACKGROUND: Atrial fibrillation (AF) is the most common sustained cardiac arrhythmia. It is also a major risk factor for ischemic stroke. The main objective of our study was to identify direct and indirect costs of AF and AF-related stroke in Slovakia. METHODS: We conducted a retrospective population-based study of AF and stroke related costs both from the third-party healthcare payers and societal perspective. The prevalence and incidence of AF and stroke were determined from central government run healthcare database. Further we estimated both indirect and direct costs of AF and stroke. All costs and healthcare resources were assessed from 2015 through 2019 and were expressed in the respective year. RESULTS: Over the 5-year study period, the prevalence of AF increased by 26% to a total of 149,198 AF cases in 2019, with an estimated total annual economic burden of €66,242,359. Direct medical costs accounted for 94% of the total cost of AF. The total cost of treating patients with stroke in 2019 was estimated at €89,505,669. As a result, the medical costs of stroke that develops as a complication of AF have been estimated to be €25,734,080 in 2019. CONCLUSIONS: Our study shows a substantial economic burden of AF and AF-related stroke in Slovakia. In view of the above, both screening for asymptomatic AF in high-risk populations and effective early management of AF with a focused on thromboprophylaxis rhythm control should be implemented.

Effectiveness, utilisation and cost associated with implantable loop recorders versus external monitors after ischaemic or cryptogenic stroke.

OBJECTIVE: Implantable loop recorders (ILRs) are increasingly used for long-term rhythm monitoring after ischaemic and cryptogenic stroke, with the goal of detecting atrial fibrillation (AF) and subsequent initiation of oral anticoagulation to reduce risk of adverse clinical outcomes. There is a need to determine the effectiveness of different rhythm monitoring strategies in this context. METHODS: We conducted a retrospective cohort analysis of individuals with commercial and Medicare Advantage insurance in Optum Labs Data Warehouse who had incident ischaemic or cryptogenic stroke and no prior cardiovascular implantable electronic device from 1 January 2016 to 30 June 2021. Patients were stratified by rhythm monitoring strategy: ILR, long-term continuous external cardiac monitor (>48 hours to 30 days) or Holter monitor (≤48 hours). The primary outcome was risk-adjusted all-cause mortality at 12 months. Secondary outcomes included new diagnosis of AF and oral anticoagulation, bleeding, and costs. RESULTS: Among 48 901 patients with ischaemic or cryptogenic stroke, 9235 received an ILR, 29 103 long-term continuous external monitor and 10 563 Holter monitor only. Mean age was 69.9 (SD 11.9) years and 53.5% were female. During the 12-month follow-up period, patients who received ILRs compared with those who received long-term continuous external monitors had a higher odds of new diagnosis of AF and oral anticoagulant initiation (adjusted OR 2.27, 95% CI 2.09 to 2.48). Compared with patients who received long-term continuous external monitors, those who received ILRs had similar 12-month mortality (HR 1.00; 95% CI 0.89 to 1.12), with approximately $13 000 higher costs at baseline (including monitor cost) and $2500 higher costs during 12-month follow-up. CONCLUSIONS: In this large real-world study of patients with ischaemic or cryptogenic stroke, ILR placement resulted in more diagnosis of AF and initiation of oral anticoagulation, but no difference in mortality compared with long-term continuous external monitors.

Comparing the outcomes and costs of cardiac monitoring with implantable loop recorders and mobile cardiac outpatient telemetry following stroke using real-world evidence.

Aim: Patients with ischemic stroke (IS) commonly undergo monitoring to identify atrial fibrillation with mobile cardiac outpatient telemetry (MCOT) or implantable loop recorders (ILRs). The authors compared readmission, healthcare cost and survival in patients monitored post-stroke with either MCOT or ILR. Materials & methods: The authors used claims data from Optum's de-identified Clinformatics® Data Mart Database to identify patients with IS hospitalized from January 2017 to December 2020 who were prescribed ambulatory cardiac monitoring via MCOT or ILR. They compared the costs associated with the initial inpatient visit as well as the rate and causes of readmission, survival and healthcare costs over the following 18 months. Datasets were balanced using patient baseline and hospitalization characteristics. Multivariable generalized linear gamma regression was used for cost comparisons. Cox proportional hazard regression was used for survival and readmission analysis. Sub-cohorts were analyzed based on the severity of the index IS. Results: In 2244 patients, readmissions were significantly lower in the MCOT monitored group (30.2%) compared with the ILR group (35.4%) (hazard ratio [HR] 1.23; 95% CI: 1.04-1.46). Average cost over 18 months starting with the index IS was $27,429 (USD) lower in the MCOT group (95% CI: $22,353-$32,633). Survival difference bordered on statistical significance and trended to lower mortality in MCOT (8.9%) versus ILR (11.3%) (HR 1.30; 95% CI: 1:00-1.69), led by significance in patients with complications or comorbidities with the index event (MCOT 7.5%, ILR 11.5%; HR 1.62; 95% CI: 1.11-2.36). Conclusion: The use of MCOT versus ILR as the primary monitor following IS was associated with significant decreases in readmission, lower costs for the initial IS and total care over the next 18 months, significantly lower mortality for patients with complications and comorbidities at the index stroke, and a trend toward improved survival across all patients.

Impact of an expanded reimbursement policy on utilization of implantable loop recorders in patients with cryptogenic stroke in Korea.

BACKGROUND/AIMS: The reimbursement policy for cryptogenic stroke (CS) was expanded in November 2018 from recurrent strokes to the first stroke episode. No reports have demonstrated whether this policy change has affected trends in implantable loop recorder (ILR) utilization. METHODS: We identified patients who received an ILR implant using the Korea Health Insurance Review and Assessment Service database between July 2016 and October 2021. Patients meeting all the following criteria were considered to have CS indication: 1) prior stroke history, 2) no previous history of atrial fibrillation or flutter (AF/AFL), and 3) no maintenance of oral anticoagulant for ≥4 weeks within a year before ILR implant. AF/AFL diagnosed within 3 years after ILR implant or before ILR removal was considered ILR-driven. RESULTS: Among 3,056 patients, 1,001 (32.8%) had CS indications. The total ILR implant number gradually increased for both CS and non-CS indications and the number of CS indication significantly increased after implementing the expanded reimbursement policy. The detection rate for AF/AFL was 26.3% in CS patients over 3 years, which was significantly higher in patients implanted with an ILR within 2 months after stroke than those implanted later. CONCLUSION: The expanded coverage policy for CS had a significant impact on the number of ILR implantation for CS indication. The diagnostic yield of ILR for AF/AFL detection seems better when ILR is implanted within 2 months than later. Further investigation is needed to demonstrate other clinical benefits and the optimal ILR implantation timing.

Characteristics of contemporary atrial fibrillation clinical trials and their association with industry sponsorship.

BACKGROUND: Industry sponsorship is an important source of funding for atrial fibrillation (AF) clinical trials, the implications of which have not been analyzed. OBJECTIVE: The purpose of this study was to determine the characteristics of contemporary AF clinical trials and to evaluate their association with funding source. METHODS: We systematically assessed all completed AF trials registered in the ClinicalTrials.gov database between conception to October 31, 2023, and extracted publicly available information including funding source, trial size, demographic distribution, intervention, location, and publication status. Trial characteristics were compared using the Wilcoxon rank-sum test and Fisher exact test for continuous and categorical variables, respectively. RESULTS: Of the 253 clinical trials assessed, 171 (68%) reported industry funding. Industry funding was associated with a greater median number of patients enrolled (172 vs 80; P <.001), publication rate (56.7% vs 42.7%; P = .04), probability of being product-focused (48.0% vs 24.4%; P <.001), and multicontinental recruitment location (25.2% vs 2.4%; P <.001) when compared to nonindustry-funded trials. However, industry funding was not associated with a significant difference in median impact factor (7.7 vs 7.7; P = .723). The overall proportion of industry-funded trials did not change over time (P = 1). CONCLUSION: Industry-funded clinical trials in AF often are larger, more frequently published, multicontinental, and product-focused. Industry funding was found to be associated with significant differences in study enrollment and publication metrics.

Are Socioeconomic Factors Associated With Atrial Fibrillation Sex-Dependent? A Narrative Review.

Atrial fibrillation (AF), the most prevalent cardiac arrhythmia, poses a significant public health and economic burden. Although socioeconomic factors such as income and education have been implicated in AF incidence and outcomes, the potential sex-specific associations remained underexplored. This narrative review aimed to fill this gap by synthesizing existing literature on the sex-specific impact of socioeconomic factors on AF incidence, treatment, and outcome. Among these socioeconomic factors, we identified income and education as the most frequently cited determinants. Nevertheless, the magnitude and direction of these sex differences remained inconsistent across studies. The review uncovered that many studies did not include sex in the analysis when assessing the impact of socioeconomic factors on AF. We highlighted that there is a paucity of studies employing sex-stratified reporting and sex interaction analyses, thereby hindering a deeper understanding of these relationships.