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Background: The PRECISE (Prospective Randomized Trial of the Optimal Evaluation of Cardiac Symptoms and Revascularization) trial compared an investigational precision diagnostic testing strategy (n=1057) with usual testing (n=1046) in patients with stable chest pain and suspected coronary artery disease. Quality of life (QOL) outcomes were a prespecified secondary end point., Methods: We assessed QOL by structured interviews in all trial participants at baseline and 45 days, 6 months, and 12 months postrandomization. QOL assessments included angina-related QOL (19-item Seattle Angina Questionnaire [SAQ-19]), generic health status (EQ-5D), and a 4-item care satisfaction survey (at 45 days only). The prespecified primary comparison was the 6-month SAQ Summary score outcomes (scale, 0 to 100; higher scores indicate greater health status). QOL data collection rates were high, with 99% complete baseline SAQ scores and 86.5% complete at the 6-month primary comparison follow-up. All comparisons were made as randomized., Results: At baseline, mean SAQ Summary scores were 70.9 in the Precision Strategy group (n=1050) and 70.4 in the Usual Testing group (n=1042). By 6 months, mean SAQ Summary scores had improved to 89.9 in the Precision Strategy group and 89.2 in the Usual Testing group, with a mean adjusted difference of 0.8 (95% CI, -0.3 to 2.0). The SAQ component scores showed similar improvement from baseline in both groups and no statistically significant or clinically meaningful differences between the 2 groups at any follow-up time point. By 6 months, 66% of patients in both groups were chest pain-free. EQ-5D visual analog scores also improved from baseline and showed no difference between groups during follow-up. Care satisfaction scores were high and similar at 45 days., Conclusions: In stable patients with symptoms suggesting coronary artery disease, angina-related and overall QOL improved substantially over the initial 6 months independent of the testing strategy assigned., Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT03702244.

Background: The PRECISE (Prospective Randomized Trial of the Optimal Evaluation of Cardiac Symptoms and Revascularization) demonstrated that a precision diagnostic strategy reduced the primary composite of death, nonfatal myocardial infarction, or catheterization without obstructive coronary artery disease by 65% in patients with nonacute chest pain compared with usual testing. Medical cost was a prespecified secondary end point., Methods: PRECISE randomized 2103 patients between December 2018 and May 2021 to usual testing or a precision strategy that used deferred testing for the lowest risk patients (20%) and coronary computed tomographic angiography with selective computed tomography-derived fractional flow reserve for the remainder. Resource use consumption data were collected from all study participants and hospital cost data from US participants (n=1125) to estimate total medical costs. The primary and secondary economic outcomes were total costs at 12 months and at 45 days, respectively, from the US health care system perspective. The mean cost differences between the 2 strategies were reported by intention-to-treat., Results: At 45 days, total costs were similar between the precision strategy and usual testing (mean difference, $182 [95% CI, -$555 to $661]). By 12 months, percutaneous coronary intervention and coronary artery bypass surgery had been performed in 7.2% and 2.0% of precision strategy patients and 3.5% and 1.7% of usual testing patients, respectively. At 1 year, precision strategy costs were $5299 versus $4821 for usual testing (mean difference, $478 [95% CI, -$889 to $1437]; P =0.43). Precision care decreased mean per-patient diagnostic cost by 27% and increased mean per-patient revascularization costs by 67%., Conclusions: In the PRECISE trial, the precision strategy, a risk-based approach endorsed by current clinical practice guidelines, improved the clinical efficiency of testing and had similar costs to usual testing at 45 days and a nonsignificant $478 cost difference at 1 year., Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT03702244.

Background: Randomized clinical trials have shown that semaglutide is associated with a clinically relevant reduction in body weight and a lower risk of adverse cardiovascular events in those who are overweight or obese with a history of cardiovascular disease but no diabetes. The objective of this study was to assess the cost-effectiveness of semaglutide for this indication., Methods: A decision analytic Markov model was used to compare the lifetime benefits and costs of semaglutide 2.4-mg subcutaneous weekly vs standard care in a hypothetical cohort of patients who were overweight or obese with preexisting cardiovascular disease (and no diabetes) from the health care payer perspective. Our model included ischemic stroke, heart failure hospitalization and/or urgent visit or myocardial infarction, and death over monthly transition cycles. Model outcomes included costs (2023 CAD$), quality-adjusted life years (QALYs), and incremental cost-effectiveness ratios., Results: Base case analysis showed that the incremental cost-effectiveness ratio for semaglutide compared with standard care was $72,962 per QALY gained with a 14% likelihood of cost-effectiveness adopting a $50,000 per QALY gained willingness to pay threshold. Factors with the greatest influence on cost-effectiveness were medication efficacy on mortality and medication cost. When the price of semaglutide was reduced by 50%, it was economically attractive at $37,190 per QALY gained with an 80% likelihood of cost-effectiveness at a $50,000 per QALY threshold., Conclusions: Semaglutide might be a cost-effective option for the publicly funded health care system contingent on initial pricing. Considering the candidate population-patients who are overweight or obese with preexisting cardiovascular disease-policymakers should consider the budget effect of funding semaglutide and weigh it against other ways scarce health care dollars might be used., (Copyright © 2024 The Authors. Published by Elsevier Inc. All rights reserved.)

Cardiac implantable electronic devices (CIEDs) are often important for regulating cardiac rate and rhythm. Pacemakers and defibrillators are among the top 10 most implanted medical devices, with > 1.5 million devices implanted annually. Although millions of patients have benefited with improved quality of life and survival, CIED systems are becoming increasingly complex and do not always perform according to expectations. Advisory notices communicate important information about the safety and performance of a medical device to health care providers and patients. Medical device recalls are common, with > 35 unique device recalls in the past 5 years. From an ethical standpoint, CIED recalls highlight a range of considerations including the consent process, duty to report, how best to promote autonomous decision-making, trust in the health care system, as well as disproportionate effects of these considerations on equity-deserving groups. The purpose of the current article is to review and advise regarding the process around medical device advisory and recall, with a specific focus on clinicians caring for patients affected by these devices. We have sought the input of a lawyer, a patient advocacy group, and an ethicist to guide the clinical management of, and communications regarding, device recalls and advisories. Diligent surveillance and a clear, transparent patient consent process regarding these small but potentially serious device anomalies is paramount in ensuring patients believe they are safe and informed. Meaningful patient engagement helps to ensure optimal communication and disclosure mechanisms before implantation and throughout follow-up, accessibility of information in the initial implant and recall action process, and trust in health care systems and providers., (Copyright © 2024 Canadian Cardiovascular Society. Published by Elsevier Inc. All rights reserved.)

Background: Open Abdomen (OA) cases represent a significant surgical and resource challenge. AbClo is a novel non-invasive abdominal fascial closure device that engages lateral components of the abdominal wall muscles to support gradual approximation of the fascia and reduce the fascial gap. The study objective was to assess the economic implications of AbClo compared to negative pressure wound therapy (NPWT) alone on OA management., Methods: We conducted a cost-minimization analysis using a decision tree comparing the use of the AbClo device to NPWT alone among patients with midline laparotomy for trauma or acute abdominal surgery who were ineligible for primary fascial closure. The time horizon was limited to the length of the inpatient hospital stay, and costs were considered from the perspective of the US Medicare payer. Clinical effectiveness data for AbClo was obtained from a randomized clinical trial. Cost data was obtained from the published literature. Probabilistic and deterministic sensitivity analyses were performed. The primary outcome was incremental cost., Results: The mean cumulative costs per patient were $76 582 for those treated with NPWT alone and $70,582 for those in the group treated with the AbClo device. Compared to NPWT alone, AbClo was associated with lower incremental costs of -$6012 (95% CI -$19 449 to +$1996). The probability that AbClo was cost-savings compared to NPWT alone was 94%., Conclusions: The use of AbClo is an economically attractive strategy for management of OA in in patients with midline laparotomy for trauma or acute abdominal surgery who were ineligible for primary fascial closure., Competing Interests: Declaration of Conflicting InterestsThe author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: TD is an employee of InventoRR MD Inc. DC reports consulting fees through the Integrated Management Platform to Accelerate Clinical Trials (IMPACT) at the University of Calgary.

Background: Few data are available regarding temporal patterns of health resource utilization (HRU) and expenditures among patients undergoing catheter ablation for paroxysmal supraventricular tachycardia (PSVT). This study aimed to describe expenditures and HRU in patients with PSVT who underwent catheter ablation compared to a matched cohort of patients on medical therapy alone., Methods: Using a large US administrative database, we identified adult patients (age 18 to 65 years) with a new PSVT diagnosis between 2008 and 2016. Propensity-score matching was used to assemble a PSVT cohort treated with ablation or medical therapy alone (N = 2556). Longitudinal trends in HRU and expenditures in the 3-years preceding and following PSVT diagnosis were compared., Results: There were no significant differences in expenditures between groups except within the first year after PSVT diagnosis: $48,004 ablation vs. $17,560 medical therapy (p < 0.001). This difference was driven by procedural expenditures, where the mean cost of catheter ablation was $32,057 ± SD 26,737. In Years 2 and 3 post-ablation, HRU and expenditures decreased to the levels associated with the medical therapy group, although fewer ablation patients required any prescription for beta-blockers, calcium channel blockers, or anti-arrhythmic drugs (32% ablation vs. 42% medical therapy group, p < 0.001)., Conclusion: Catheter ablation reduces medication burden in PSVT, yet health resource use and expenditures were similar beyond 2 years post-ablation when compared to PSVT patients on medical therapy alone. Additional studies are required to better understand drivers of these sustained health expenditures, and barriers to achieving cost-savings for a potentially curative procedure., Competing Interests: Declaration of competing interest DC reports research grant support from the Heart and Stroke Foundation of Canada and the Canadian Institutes of Health Research. SDP reports research grant support from Boston Scientific, Bristol-Myers Squibb, Pfizer, Janssen Pharmaceuticals, Gilead; and advisory board/speakers honoraria from Boston Scientific, Medtronic, Bristol-Myers Squibb, Pfizer, Janssen Pharmaceuticals, and Zoll. RS is employed by Milestone Pharmaceuticals. The remaining authors have no conflicts of interest to disclose., (Copyright © 2024 The Authors. Published by Elsevier B.V. All rights reserved.)

Aims: Prior studies suggest that sodium-glucose cotransporter-2 inhibitors (SGLT2is) may decrease the incidence of atrial fibrillation (AF). However, it is unknown whether SGLT2i can attenuate the disease course of AF among patients with pre-existing AF and Type II diabetes mellitus (DM). In this study, our objective was to examine the association between SGLT2i prescription and arrhythmic outcomes among patients with DM and pre-existing AF., Methods and Results: We conducted a population-based cohort study of adults with DM and AF between 2014 and 2019. Using a prevalent new-user design, individuals prescribed SGLT2i were matched 1:1 to those prescribed dipeptidyl peptidase-4 inhibitors (DPP4is) based on time-conditional propensity scores. The primary endpoint was a composite of AF-related healthcare utilization (i.e. hospitalization, emergency department visits, electrical cardioversion, or catheter ablation). Secondary outcome measures included all-cause mortality, heart failure (HF) hospitalization, and ischaemic stroke or transient ischaemic attack (TIA). Cox proportional hazard models were used to examine the association of SGLT2i with the study endpoint. Among 2242 patients with DM and AF followed for an average of 3.0 years, the primary endpoint occurred in 8.7% (n = 97) of patients in the SGLT2i group vs. 10.0% (n = 112) of patients in the DPP4i group [adjusted hazard ratio 0.73 (95% confidence interval 0.55-0.96; P = 0.03)]. Sodium-glucose cotransporter-2 inhibitors were associated with significant reductions in all-cause mortality and HF hospitalization, but there was no difference in the risk of ischaemic stroke/TIA., Conclusion: Among patients with DM and pre-existing AF, SGLT2is are associated with decreased AF-related health resource utilization and improved arrhythmic outcomes compared with DPP4is., Competing Interests: Conflict of interest: D.L. has received in-kind support from Abbott Laboratories for a trial of continuous glucose monitors. S.B.W. has received grant funding from Servier Inc., unrelated to this work. D.S.C. reports grant funding from the Canadian Institutes of Health Research and the Heart and Stroke Foundation of Canada. The remaining authors report no relevant disclosures., (© The Author(s) 2024. Published by Oxford University Press on behalf of the European Society of Cardiology.)

Aim: To estimate the real-world effectiveness of sodium-glucose co-transporter-2 inhibitors (SGLT2is) versus dipeptidyl peptidase-4 inhibitors (DPP4is) at reducing loss of kidney function and adverse kidney events in adults with varying levels of albuminuria., Materials and Methods: In this retrospective cohort study using administrative data, we matched new SGLT2i users 1:2 to DPP4i users on diabetes therapy, chronic kidney disease (CKD) stage, albuminuria and time-conditional propensity score. Albuminuria was defined by spot urine albumin or equivalent as mild, moderate or severe. Linear regression was used to model the estimated glomerular filtration rate (eGFR), and Poisson regression for a composite kidney outcome (> 40% loss of eGFR, kidney replacement therapy or death from kidney causes) and all-cause mortality., Results: SGLT2i users (n = 19 238, median age 57.9 years, female 40.9%) had mostly nil/mild albuminuria (70.7%). SGLT2is were associated with a 1.36 (95% CI 0.98-1.74) mL/min/1.73m 2 (P < .001) acute (≤ 60 days) decline in eGFR, relative to DPP4is. Thereafter, SGLT2is were associated with 1.04 (95% CI 0.93-1.15) mL/min/1.73m 2 (P < .001) less annual eGFR loss. SGLT2i users had fewer adverse kidney outcomes (incidence rate ratio [IRR] 0.58 [0.47-0.71]; P < .001), but not all-cause mortality (IRR 0.82 [0.66-1.01]; P = .06). Outcomes were similar considering only those with nil/mild albuminuria., Conclusions: SGLT2is may prevent eGFR decline and reduce the risk of adverse kidney events in adults with diabetes and nil or non-severe albuminuria., (© 2023 The Authors. Diabetes, Obesity and Metabolism published by John Wiley & Sons Ltd.)

The microbiology of cardiac implantable electronic device (CIED) infections in Calgary, Alberta was described, identifying 50 infections from 2013 to 2019. The majority were Staphylococcus aureus (40.0%). There is significant economic burden, mostly related to inpatient costs, associated with CIED infections. However, there were no significant differences in costs stratified by organism., Competing Interests: All authors report no conflicts of interest relevant to this article., (© The Author(s) 2024.)

Background: The influence of fee-for-service reimbursement on cardiac imaging has not been compared with other payment models. Furthermore, variation in ordering practices is not well understood., Methods and Results: This retrospective, population-based cohort study using linked administrative data from Alberta, Canada included adults with chronic heart disease (atrial fibrillation, coronary artery disease, and heart failure) seen by cardiac specialists for a new outpatient consultation April 2012 to December 2018. Generalized linear mixed-effects models estimated the association of payment model (including the ability to bill to interpret imaging tests) and the use of cardiac imaging and quantified variation in cardiac imaging. Among 31 685 adults seen by 308 physicians at 136 sites, patients received an observed mean of 0.67 (95% CI, 0.67-0.68) imaging tests per consultation. After adjustment, patients seeing fee-for-service physicians had 2.07 (95% CI, 1.68-2.54) and fee-for-service physicians with ability to interpret had 2.87 (95% CI, 2.16-3.81) times the rate of receiving a test than those seeing salaried physicians. Measured patient, physician, and site effects accounted for 31% of imaging variation and, following adjustment, reduced unexplained site-level variation 40% and physician-level variation 29%., Conclusions: We identified substantial variation in the use of outpatient cardiac imaging related to physician and site factors. Physician payment models have a significant association with imaging use. Our results raise concern that payment models may influence cardiac imaging practice. Similar methods could be applied to identify the source and magnitude of variation in other health care processes and outcomes.

Background: The VICTORIA trial (Vericiguat Global Study in Subjects With Heart Failure With Reduced Ejection Fraction) demonstrated that, in patients with high-risk heart failure, vericiguat reduced the primary composite outcome of cardiovascular death or heart failure hospitalization relative to placebo. The hazard ratio for all-cause mortality was 0.95 (95% CI, 0.84-1.07). In a prespecified analysis, treatment effects varied substantially as a function of baseline NT-proBNP (N-terminal pro-B-type natriuretic peptide) levels, with survival benefit for vericiguat in the lower NT-proBNP quartiles (hazard ratio, 0.82 [95% CI, 0.69-0.97]) and no benefit in the highest NT-proBNP quartile (hazard ratio, 1.14 [95% CI, 0.95-1.38]). An economic analysis was a major secondary objective of the VICTORIA research program., Methods: Medical resource use data were collected for all VICTORIA patients (N=5050). Costs were estimated by applying externally derived US cost weights to resource use counts. Life expectancy was projected from patient-level empirical trial survival results with the use of age-based survival modeling methods. Quality-of-life adjustments were based on prospectively collected EQ-5D-based utilities. The primary outcome was the incremental cost-effectiveness ratio, comparing vericiguat with placebo, assessed from the US health care sector perspective over a lifetime horizon. Cost-effectiveness was estimated using the total VICTORIA cohort, both with and without interaction between treatment and baseline NT-proBNP., Results: Life expectancy modeling results varied according to whether the observed heterogeneity of treatment effect by baseline NT-proBNP values was incorporated into the modeling. Including the interaction term, the vericiguat arm had an estimated quality-adjusted life expectancy of 4.56 quality-adjusted life-years (QALYs) compared with 4.13 QALYs for placebo (incremental discounted QALY, 0.43). Without the treatment heterogeneity/interaction term, vericiguat had 4.50 QALYs compared with 4.33 QALYs for placebo (incremental discounted QALY, 0.17). Incremental discounted costs (vericiguat minus placebo) were $28 546 with the treatment interaction and $20 948 without it. Corresponding incremental cost-effectiveness ratios were $66 509 per QALY allowing for treatment heterogeneity and $124 512 without heterogeneity., Conclusions: Vericiguat use in the VICTORIA trial met criteria for intermediate value, but the incremental cost-effectiveness ratio estimates were sensitive to whether the analysis accounted for observed NT-proBNP treatment effect heterogeneity. The cost-effectiveness of vericiguat was driven by the projected incremental life expectancy among patients in the lowest 3 quartiles of NT-proBNP., Registration: URL: https://www., Clinicaltrials: gov; Unique identifier: NCT02861534., Competing Interests: Disclosures Dr Cowper reports research grant support from Merck, Eli Lilly, Novartis, AstraZeneca, Bristol Myers Squibb, AGA Medical, Tenax Therapeutics, GE Healthcare, Mayo Clinic, and Gilead. Dr Anstrom reports research support from the National Institutes of Health and Patient-Centered Outcomes Research Institute and research support from Bayer and Merck outside the submitted work. Dr Hernandez reports research grants from American Regent, Amgen, AstraZeneca, Bayer, Boehringer Ingelheim, Bristol-Myers Squib, Merck, Novartis, and Verily, as well as consulting from Amgen, AstraZeneca, Bayer, Boehringer Ingelheim, Boston Scientific, Myokardia, and Novartis. Dr O’Connor reports consulting fees from Merck. Dr Armstrong reports receiving grant support from Merck, Boehringer Ingelheim, and Bayer and consulting fees from Novo Nordisk. Dr Mark reports grants from the National Institutes of Health/National Heart, Lung, and Blood Institute and Mayo Clinic during the conduct of the study; grants from Merck and HeartFlow; and consulting fees from Novartis and Boehringer Ingelheim outside the submitted work. Dr Bigelow reports stock holdings in Merck, Johnson & Johnson, Covidien, Pfizer, Sanofi, McKesson, Viatris and Organon, as well as consulting fees from Rafael and Elixir Medical. The other authors report no conflicts.

Objective: To establish the epidemiology of cardiac implantable electronic device (CIED) infections in Alberta, Canada, using validated administrative data., Design: Retrospective, population-based cohort study., Setting: Alberta Health Services is a province-wide health system that services all of Alberta, Canada., Participants: Adult patients who underwent first-time CIED implantation or generator replacement in Alberta, Canada, between January 1, 2011, and December 31, 2019., Methods: CIED implant patients were identified from the Paceart database. Patients who developed an infection within 1 year of the index procedure were identified through validated administrative data (International Classification of Diseases, Tenth Revision in Canada). Demographic characteristics of patients were summarized. Logistic regression models were used to analyze device type, comorbidities, and demographics associated with infection rates and mortality., Results: Among 27,830 CIED implants, there were 205 infections (0.74%). Having 2 or more comorbidities was associated with higher infection risk. Generator replacement procedures (odds ratio [OR], 0.55; 95% confidence interval [CI], 0.34-0.84; P = .008), age increase of every 10 years (OR, 0.73; 95% CI, 0.66-0.82; P ≤ .001), and index procedure after 2014 were associated with decreased risk. Comparing the infected to uninfected groups, the hospitalization rates were 2.63 compared to 0.69, and the mortality rates were 10.73% compared to 3.49%, respectively (P < .001)., Conclusions: There is a slightly lower overall rate of CIED infections Alberta, Canada compared to previously described epidemiology. Implants after 2014, and generator replacements showed a decreased burden of infection. Patients with younger age, and 2 or more comorbidities are at greatest risk of CIED infection. The burden of hospitalization and mortality is substantially higher in infected patients.

Purpose: While implantable cardioverter-defibrillator (ICD) therapy provides clear benefit in patients with ischemic cardiomyopathy (ICM), this is less clear in patients with non-ischemic cardiomyopathy (NICM). Mid-wall striae (MWS) fibrosis is an established cardiovascular magnetic resonance (CMR) risk marker observed in patients with NICM. We evaluated whether patients with NICM and MWS have similar risk of arrhythmia-related cardiovascular events as patients with ICM., Methods: We studied a cohort of patients undergoing CMR. The presence of MWS was adjudicated by experienced physicians. The primary outcome was a composite of implantable cardioverter-defibrillator (ICD) implant, hospitalization for ventricular tachycardia, resuscitated cardiac arrest, or sudden cardiac death. Propensity-matched analysis was performed to compare outcomes for patients NICM with MWS and ICM., Results: A total of 1,732 patients were studied, 972 NICM (706 without MWS, 266 with MWS) and 760 ICM. NICM patients with MWS were more likely to experience the primary outcome versus those without MWS (unadjusted subdistribution hazard ratio (subHR) 2.26, 95% confidence interval [CI] 1.51-3.41) with no difference versus ICM patients (unadjusted subHR 1.32, 95% CI 0.93-1.86). Similar results were seen in a propensity-matched population (adjusted subHR 1.11, 95% CI 0.63-1.98, p = 0.711)., Conclusion: Patients with NICM and MWS demonstrate significantly higher arrhythmic risk compared to NICM without MWS. After adjustment, the arrhythmia risk of patients with NICM and MWS was similar to patients with ICM. Accordingly, physicians could consider the presence of MWS when making clinical decisions regarding arrhythmia risk management in patients with NICM., (© 2023. The Author(s), under exclusive licence to Springer Nature B.V.)

Remote monitoring is beneficial for the management of patients with cardiovascular implantable electronic devices by impacting morbidity and mortality. With increasing numbers of patients using remote monitoring, keeping up with higher volume of remote monitoring transmissions creates challenges for device clinic staff. This international multidisciplinary document is intended to guide cardiac electrophysiologists, allied professionals, and hospital administrators in managing remote monitoring clinics. This includes guidance for remote monitoring clinic staffing, appropriate clinic workflows, patient education, and alert management. This expert consensus statement also addresses other topics such as communication of transmission results, use of third-party resources, manufacturer responsibilities, and programming concerns. The goal is to provide evidence-based recommendations impacting all aspects of remote monitoring services. Gaps in current knowledge and guidance for future research directions are also identified., (Copyright © 2023 Heart Rhythm Society, European Society of Cardiology, Asia Pacific Heart Rhythm Society, and the Latin American Heart Rhythm Society published by Elsevier Inc, Oxford University Press and Wiley. Published by Elsevier Inc. All rights reserved.)

In the past decades there has been a substantial evolution in data management and data processing techniques. New data architectures made analysis of big data feasible, healthcare is orienting towards personalized medicine with digital health initiatives, and artificial intelligence (AI) is becoming of increasing importance. Despite being a trendy research topic, only very few applications reach the stage where they are implemented in clinical practice. This review provides an overview of current methodologies and identifies clinical and organizational challenges for AI in healthcare., Competing Interests: DP and SG are employed by Intelense Inc. DP is employed by IOT/AI - Caliber Interconnect Pvt Ltd. The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (© 2023 Vandenberk, Chew, Prasana, Gupta and Exner.)

Background: Choosing Wisely Canada (CWC) recommends avoiding noninvasive advanced cardiac testing (e.g., exercise stress testing [EST], echocardiography and myocardial perfusion imaging [MPI]) for preoperative assessment in patients scheduled to undergo low-risk noncardiac surgery. In this study, we assessed the temporal trends in testing, overlapping with the introduction of the CWC recommendations in 2014, and patient and provider factors associated with low-value testing., Methods: In this population-based retrospective cohort study, we used linked health administrative data in Alberta, Canada, to identify adult patients who underwent elective noncardiac surgery between Apr. 1, 2011, and Mar. 31, 2019, who had preoperative noninvasive advanced cardiac tests (EST, echocardiography or MPI) within 6 months before surgery. We included electrocardiography as an exploratory outcome. We excluded patients at high risk using the Revised Cardiac Risk Index (score ≥ 1 considered to indicate high risk), and modelled patient and temporal factors associated with the number of tests., Results: We identified 1 045 896 elective noncardiac operations performed in 798 599 patients and 25 599 advanced preoperative cardiac tests; 2.1% of operations were preceded by advanced cardiac testing. The incidence of testing increased over the study period, and, by 2018/19, patients were 1.3 times (95% confidence interval 1.2-1.4) more likely to receive a preoperative advanced test compared to 2011/12. Urban patients were more likely to receive a preoperative advanced cardiac test than their rural counterparts. Electrocardiography was the most common preoperative cardiac test, preceding 182 128 procedures (17.4%)., Interpretation: Preoperative advanced cardiac testing was infrequent in adult Albertans who underwent low-risk elective noncardiac operations. Despite CWC recommendations, the use of some tests appears to be increasing, and there was substantial variation across geographic areas., Competing Interests: Competing interests: None declared., (© 2023 CMA Impact Inc. or its licensors.)

Remote monitoring is beneficial for the management of patients with cardiovascular implantable electronic devices by impacting morbidity and mortality. With increasing numbers of patients using remote monitoring, keeping up with higher volume of remote monitoring transmissions creates challenges for device clinic staff. This international multidisciplinary document is intended to guide cardiac electrophysiologists, allied professionals, and hospital administrators in managing remote monitoring clinics. This includes guidance for remote monitoring clinic staffing, appropriate clinic workflows, patient education, and alert management. This expert consensus statement also addresses other topics such as communication of transmission results, use of third-party resources, manufacturer responsibilities, and programming concerns. The goal is to provide evidence-based recommendations impacting all aspects of remote monitoring services. Gaps in current knowledge and guidance for future research directions are also identified., (Published by Oxford University Press on behalf of the European Society of Cardiology 2023.)

Remote monitoring is beneficial for the management of patients with cardiovascular implantable electronic devices by impacting morbidity and mortality. With increasing numbers of patients using remote monitoring, keeping up with higher volume of remote monitoring transmissions creates challenges for device clinic staff. This international multidisciplinary document is intended to guide cardiac electrophysiologists, allied professionals, and hospital administrators in managing remote monitoring clinics. This includes guidance for remote monitoring clinic staffing, appropriate clinic workflows, patient education, and alert management. This expert consensus statement also addresses other topics such as communication of transmission results, use of third-party resources, manufacturer responsibilities, and programming concerns. The goal is to provide evidence-based recommendations impacting all aspects of remote monitoring services. Gaps in current knowledge and guidance for future research directions are also identified., (© 2023 Heart Rhythm Society, European Society of Cardiology, Asia Pacific Heart Rhythm Society, and the Latin American Heart Rhythm Society published by Elsevier Inc, Oxford University Press and Wiley.)

Cardiac electrophysiology is a constantly evolving speciality that has benefited from technological innovation and refinements over the past several decades. Despite the potential of these technologies to reshape patient care, their upfront costs pose a challenge to health policymakers who are responsible for the assessment of the novel technology in the context of increasingly limited resources. In this context, it is critical for new therapies or technologies to demonstrate that the measured improvement in patients' outcomes for the cost of achieving that improvement is within conventional benchmarks for acceptable health care value. The field of Health Economics, specifically economic evaluation methods, facilitates this assessment of value in health care. In this review, we provide an overview of the basic principles of economic evaluation and provide historical applications within the field of cardiac electrophysiology. Specifically, the cost-effectiveness of catheter ablation for both atrial fibrillation (AF) and ventricular tachycardia, novel oral anticoagulants for stroke prevention in AF, left atrial appendage occlusion devices, implantable cardioverter defibrillators, and cardiac resynchronization therapy will be reviewed., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (© 2023 Hijazi, Vandenberk, Rennert-May, Quinn, Sumner and Chew.)

The history of cardiac pacing dates back to the 1930s with externalized pacing and has evolved to incorporate transvenous, multi-lead, or even leadless devices. Annual implantation rates of cardiac implantable electronic devices have increased since the introduction of the implantable system, likely related to expanding indications, and increasing global life expectancy and aging demographics. Here, we summarize the relevant literature on cardiac pacing to demonstrate the enormous impact it has had within the field of cardiology. Further, we look forward to the future of cardiac pacing, including conduction system pacing and leadless pacing strategies.

Background: Alert-driven remote patient monitoring (RPM) or fully virtual care without routine evaluations may reduce clinic workload and promote more efficient resource allocation, principally by diminishing nonactionable patient encounters., Objective: The purpose of this study was to conduct a cost-consequence analysis to compare 3 postimplant implantable cardioverter-defibrillator (ICD) follow-up strategies: (1) in-person evaluation (IPE) only; (2) RPM-conventional (hybrid of IPE and RPM); and (3) RPM-alert (alert-based ICD follow-up)., Methods: We constructed a decision-analytic Markov model to estimate the costs and benefits of the 3 strategies over a 2-year time horizon from the perspective of the US Medicare payer. Aggregate and patient-level data from the TRUST (Lumos-T Safely RedUceS RouTine Office Device Follow-up) randomized clinical trial informed clinical effectiveness model inputs. TRUST randomized 1339 patients 2:1 to conventional RPM or IPE alone, and found that RPM was safe and reduced the number of nonactionable encounters. Cost data were obtained from the published literature. The primary outcome was incremental cost., Results: Mean cumulative follow-up costs per patient were $12,688 in the IPE group, $12,001 in the RPM-conventional group, and $11,011 in the RPM-alert group. Compared to the IPE group, both the RPM-conventional and RPM-alert groups were associated with lower incremental costs of -$687 (95% confidence interval [CI] -$2138 to +$638) and -$1,677 (95% CI -$3134 to -$304), respectively. Therefore, the RPM-alert strategy was most cost-effective, with an estimated cost-savings in 99% of simulations., Conclusions: Alert-driven RPM was economically attractive and, if patient outcomes and safety are comparable to those of conventional RPM, may be the preferred strategy for ICD follow-up., (Copyright © 2022 Heart Rhythm Society. Published by Elsevier Inc. All rights reserved.)

Objectives: Our aim in this study was to describe patterns and patient-level factors associated with use of sodium-glucose cotransporter-2 inhibitors (SGLT2is) among adults with diabetes being treated in Alberta, Canada., Methods: Using linked administrative data sets from 2014 to 2019, we defined a retrospective cohort of adults with prevalent or incident type 2 diabetes with indications for SGLT2i use and who did not have advanced kidney disease (glomerular filtration rate <30 mL/min per 1.73 m 2 ) or previous amputation. We describe medication dispensation patterns of SGLT2is over time in the overall cohort and among the subgroup with cardiovascular disease (CVD). Multivariable logistic regression was used to determine patients' characteristics associated with SGLT2i use., Results: Of the 341,827 patients with diabetes (mean age, 60.7 years; 45.6% female), 107,244 (31.3%) had CVD. The proportion of patients with an SGLT2i prescription increased in a linear fashion to a maximum of 10.8% (95% confidence interval [CI], 10.7% to 10.9%) of the eligible cohort by the end of the observation period (March 2019). The proportion of filled prescriptions was similar for patients with CVD (10.4%; 95% CI, 10.1% to 10.6%) and for those without CVD (10.9%; 95% CI, 10.8% to 11.0%). Patients' characteristics associated with lower odds of filling an SGLT2i prescription included female sex, older age and lower income., Conclusions: The use of SGLT2is is increasing among patients with diabetes but remains low even in those with CVD. Policy and practice changes to increase prescribing, especially in older adults, may help to reduce morbidity and mortality related to cardiovascular and renal complications., (Copyright © 2022 Canadian Diabetes Association. Published by Elsevier Inc. All rights reserved.)

Aims: To compare the cost-effectiveness of immediate and 12-month delayed initiation of dapagliflozin treatment in patients with a history of hospitalization for heart failure (HHF) from the UK, Canadian, German, and Spanish healthcare perspectives., Methods and Results: A cost-utility analysis was conducted using a decision-analytic Markov model with health states defined by Kansas City Cardiomyopathy Questionnaire scores, type 2 diabetes mellitus status and incidence of heart failure (HF) events. Patient-level data for patients with prior HHF from the Dapagliflozin And Prevention of Adverse-outcomes in Heart Failure (DAPA-HF) trial were used to inform the model inputs on clinical events and utility values. Healthcare costs were sourced from the relevant national reference databases and the published literature. Compared to standard therapy, immediate initiation of dapagliflozin decreased HHF (187 events), urgent HF visits (32 events) and cardiovascular mortality (18 events). Standard therapy was associated with lifetime costs of £13 224 and 4.02 quality-adjusted life years (QALYs). Twelve-month delayed initiation of dapagliflozin was associated with total discounted lifetime costs and QALYs of £16 660 and 4.61, respectively, compared to £16 912 and 4.66, respectively, for immediate initiation. Compared to standard therapy, immediate and 12-month delayed initiation of dapagliflozin yielded an incremental cost-effectiveness ratio (ICER) of £5779 and £5821, respectively. Compared to 12-month delayed initiation, immediate initiation of dapagliflozin had an ICER of £5263. Results were similar from the Canadian, German, and Spanish healthcare perspectives., Conclusion: Both immediate and 12-month delayed initiation of dapagliflozin are cost-effective. However, immediate initiation provides greater clinical benefits, with almost 10% additional QALYs gain, compared to 12-month delayed initiation of dapagliflozin and should be considered standard of care., (© 2023 Health Economics and Outcomes Research, AstraZeneca and The Authors. European Journal of Heart Failure published by John Wiley & Sons Ltd on behalf of European Society of Cardiology.)

Sex and racial disparities in the presentation, diagnosis, and management of cardiac arrhythmias are recognized. Sex-specific differences in electrophysiological parameters are well known and are predominantly related to differences in ion channel expression and the influence of sex hormones. However, the relationship between hormonal or racial influence and arrhythmia mechanisms, presentation, and management needs to be better defined. Women and racial and ethnic groups are less likely to undergo catheter ablation procedures for treatment of cardiac arrhythmias. Underrepresentation of women and racial/ethnic groups in clinical trials has resulted in significant knowledge gaps. Whether sex and racial disparities in arrhythmia management reflect barriers in access to care, physician bias, patient values, and preferences or other factors requires further study., (© 2022 Heart Rhythm Society. Published by Elsevier Inc.)

Background: Cardioneuroablation (CNA) has emerged as promising therapy for patients with refractory vasovagal syncope (VVS)., Objective: The purpose of this study was to provide a freedom from syncope estimate for CNA, including subgroup analysis by method and target of ablation., Methods: A systematic search was performed in MEDLINE and EMBASE according to the PRISMA guidelines until February 14, 2022. Observational studies and clinical trials reporting freedom from syncope were included. Meta-analysis was performed with a random-effects model., Results: A total of 465 patients were included across 14 studies (mean age 39.8 ± 4.0 year; 53.5% female). Different techniques were used to guide CNA: 50 patients (10.8%) by mapping fractionated electrograms, 73 (15.7%) with the spectral method, 210 (45.2%) with high-frequency stimulation, 73 (15.7%) with a purely anatomically guided method, and 59 (12.6%) with a combination. The target was biatrial in 168 patients (36.1%), left atrium only in 259 (55.7%), and right atrium only in 38 (8.2%). The freedom from syncope was 91.9% (95% confidence interval [CI] 88.1%-94.6%; I 2 = 6.9%; P = .376). CNA limited to right atrial ablation was associated with a significant lower freedom from syncope (81.5%; 95% CI 51.9%-94.7%; P <.0001) vs left atrial ablation only (94.0%; 95% CI 88.6%--6.9%) and biatrial ablation (92.7%; 95% CI 86.8%-96.1%). Subgroup analysis according to the technique used to identify ganglionated plexi did not show any significant difference in freedom from syncope (P = .206)., Conclusion: This meta-analysis suggests a high freedom from syncope after CNA in VVS. Well-designed, double-blind, multicenter, sham-controlled randomized clinical trials are needed to provide evidence for future guidelines., (Copyright © 2022 Heart Rhythm Society. Published by Elsevier Inc. All rights reserved.)

Background: Patient-reported outcomes (PROs) are important measures of treatment effect and can be used to inform the approval of cardiovascular drugs and devices by the U.S. Food and Drug Administration (FDA)., Purpose: To catalogue the health status patient-reported outcome measures (PROMs) validated in cardiovascular diseases (CVDs), describe their psychometric properties, and assess adherence with both FDA recommendations and the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) framework., Data Sources: MEDLINE, EMBASE, CINAHL, and Allied and Complementary Medicine Database from inception to August 2022., Study Selection: Studies that developed and/or validated health status PROMs in CVD populations., Data Extraction: Two study authors extracted data on CVD type, PROM psychometric properties, and adherence to FDA recommendations. The risk of bias informing the development or validation of PROMs was assessed using the COSMIN framework., Data Synthesis: Fifty health status PROMs (described in 83 studies) were identified, of which 45 were disease specific and 5 were generic. Eleven (22%) of the 50 PROMs validated in CVDs had minimally important differences (MIDs) established, and 8 (16%) reported on the validation of all psychometric properties recommended by the FDA. By COSMIN standards, only 2 PROMs (4%) had all of their psychometric properties rated as sufficient in quality, and 32 PROMs (64%) had less than 50% of psychometric properties rated as sufficient., Limitation: The quality of reporting varied across included studies., Conclusion: Of 50 PROMs validated in CVDs, only a small minority reported on the validation of all FDA-recommended psychometric properties, had psychometric properties rated as sufficient by COSMIN, or had MIDs established. Given the use of PROMs to guide FDA approvals of drugs and devices in CVDs, there is a need for better adherence to quality standards in PROM validation., Primary Funding Source: None.

Background: Left atrial appendage occlusion (LAAO) is a potential alternative to oral anticoagulants in selected patients with atrial fibrillation (AF). Compared with anticoagulants, LAAO decreases major bleeding risk, but there is uncertainty regarding the risk for ischemic stroke compared with anticoagulation., Objective: To determine the optimal strategy for stroke prevention conditional on a patient's individual risks for ischemic stroke and bleeding., Design: Decision analysis with a Markov model., Data Sources: Evidence from the published literature informed model inputs., Target Population: Women and men with nonvalvular AF and without prior stroke., Time Horizon: Lifetime., Perspective: Clinical., Intervention: LAAO versus warfarin or direct oral anticoagulants (DOACs)., Outcome Measures: The primary end point was clinical benefit measured in quality-adjusted life-years., Results of Base-Case Analysis: The baseline risks for stroke and bleeding determined whether LAAO was preferred over anticoagulants in patients with AF. The combined risks favored LAAO for higher bleeding risk, but that benefit became less certain at higher stroke risks. For example, at a HAS-BLED score of 5, LAAO was favored in more than 80% of model simulations for CHA 2 DS 2 -VASc scores between 2 and 5. The probability of LAAO benefit in QALYs (>80%) at lower bleeding risks (HAS-BLED score of 0 to 1) was limited to patients with lower stroke risks (CHA 2 DS 2 -VASc score of 2). Because DOACs carry lower bleeding risks than warfarin, the net benefit of LAAO is less certain than that of DOACs., Results of Sensitivity Analysis: Results were consistent using the ORBIT bleeding score instead of the HAS-BLED score, as well as alternative sources for LAAO clinical effectiveness data., Limitation: Clinical effectiveness data were drawn primarily from studies on the Watchman device., Conclusion: Although LAAO could be an alternative to anticoagulants for stroke prevention in patients with AF and high bleeding risk, the overall benefit from LAAO depends on the combination of stroke and bleeding risks in individual patients. These results suggest the need for a sufficiently low stroke risk for LAAO to be beneficial. The authors believe that these results could improve shared decision making when selecting patients for LAAO., Primary Funding Source: None.

Background: In the CABANA trial (Catheter Ablation vs Antiarrhythmic Drug Therapy for Atrial Fibrillation), catheter ablation did not significantly reduce the primary end point of death, disabling stroke, serious bleeding, or cardiac arrest compared with drug therapy by intention-to-treat, but did improve the quality of life and freedom from atrial fibrillation recurrence. In the heart failure subgroup, ablation improved both survival and quality of life. Cost-effectiveness was a prespecified CABANA secondary end point., Methods: Medical resource use data were collected for all CABANA patients (N=2204). Costs for hospital-based care were assigned using prospectively collected bills from US patients (n=1171); physician and medication costs were assigned using the Medicare Fee Schedule and National Average Drug Acquisition Costs, respectively. Extrapolated life expectancies were estimated using age-based survival models. Quality-of-life adjustments were based on EQ-5D-based utilities measured during the trial. The primary outcome was the incremental cost-effectiveness ratio, comparing ablation with drug therapy on the basis of intention-to-treat, and assessed from the US health care sector perspective., Results: Costs in the first 3 months averaged $20 794±SD 1069 higher with ablation compared with drug therapy. The cumulative within-trial 5-year cost difference was $19 245 (95% CI, $11 360-$27 170) and the lifetime mean cost difference was $15 516 (95% CI, -$2963 to $35,512) higher with ablation than with drug therapy. The drug therapy arm accrued an average of 12.5 life-years (LYs) and 10.7 quality-adjusted life-years (QALYs). For the ablation arm, the corresponding estimates were 12.6 LYs and 11.0 QALYs. The incremental cost-effectiveness ratio was $57 893 per QALY gained, with 75% of bootstrap replications yielding an incremental cost-effectiveness ratio < $100 000 per QALY gained. With no quality-of-life/utility adjustments, the incremental cost-effectiveness ratio was $183 318 per LY gained., Conclusions: Catheter ablation of atrial fibrillation was economically attractive compared with drug therapy in the CABANA Trial overall at present benchmarks for health care value in the United States on the basis of projected incremental QALYs but not LYs alone.

Background: Assessment of potential geographic variation in quality indicators of atrial fibrillation care may identify opportunities for improvement in the quality of atrial fibrillation care. The objective of this study was to assess for potential geographic variation in the quality of atrial fibrillation care in Alberta, Canada., Methods: In a population-based cohort of adults (age ≥ 18 yr) with incident nonvalvular atrial fibrillation (NVAF) diagnosed between Apr. 1, 2008, and Mar. 31, 2016, in Alberta, we investigated the variation in national quality indicators of atrial fibrillation care developed by the Canadian Cardiovascular Society. Specifically, we assessed the geographic and temporal variation in the proportion of patients with initiation of oral anticoagulant therapy, persistence with therapy, ischemic stroke and major bleeding outcomes 1 year after atrial fibrillation diagnosis using linked administrative data sets. We defined stroke risk using the CHADS 2 score. We assessed geographic variation using small-area variation statistics and geospatial data analysis., Results: Of the 64 093 patients in the study cohort (35 019 men [54.6%] and 29 074 women [45.4%] with a mean age of 69 [standard deviation 15.9] yr), 36 199 were at high risk for stroke and 14 411 were at moderate risk. Within 1 year of NVAF diagnosis, 20 180 patients (55.7%) in the high-risk group and 6448 patients (44.7%) in the moderate-risk group were prescribed anticoagulation. A total of 2187 patients (3.4%) had an ischemic stroke, and 2996 patients (4.7%) experienced a major bleed. There was substantial regional variation observed in initiation of oral anticoagulant therapy but not in the proportion of patients with ischemic stroke or major bleeding. Among the 64 Health Status Areas in Alberta, therapy initiation rates ranged from 22.6% to 71.2% among patients at high stroke risk and from 22.7% to 55.8% among those at moderate stroke risk, with clustering of lower therapy initiation rates in rural northern regions., Interpretation: The rate of initiation of oral anticoagulant therapy among adults with incident atrial fibrillation was less than 60% in patients in whom oral anticoagulant therapy would be considered guideline-appropriate care. The large geographic variation in oral anticoagulant prescribing warrants additional study into patient, provider and health care system factors that contribute to variation and drive disparities in high-quality, equitable atrial fibrillation care., Competing Interests: Competing interests: Derek Exner reports research grants and personal fees from Abbott, GE Healthcare, Medtronic Canada and HelpWear, outside the submitted work. Stephen Wilton reports research grants from Abbott, Medtronic Canada and Boston Scientific, and consulting feeds from ARCA Biopharma, outside the submitted work. No other competing interests were declared., (© 2022 CMA Impact Inc. or its licensors.)

Background: Despite expert recommendations advocating use of remote monitoring (RM) of cardiac implantable electronic devices, implementation in routine clinical practice remains modest due to inconsistent funding policies across health systems and uncertainty regarding the efficacy of RM to reduce adverse cardiovascular outcomes., Methods: We conducted a population-based cohort study of patients with de novo implantable cardioverter-defibrillators (ICDs) with or without cardiac resynchronization therapy (CRT-D), using administrative health data in Alberta, Canada, from 2010 to 2016. We assessed RM status as a predictor of all-cause mortality and cardiovascular (CV) hospitalization using Cox proportional hazards modelling, and direct health costs by generalized linear models. From this real-world data, we then constructed a decision-analytic Markov model to estimate the projected costs and benefits associated with RM compared with in-clinic visit follow-up alone., Results: Among 2799 ICD and CRT-D patients, 1830 (63.4%) were followed by RM for a mean follow-up of 50.3 months. After adjustment for age, sex, and comorbidities, RM was associated with a lower risk of death (hazard ratio [HR] 0.43, 95% confidence interval [CI] 0.36-0.52; P < 0.001) and CV hospitalization (HR 0.76, 95% CI 0.64-0.91; P = 0.002). In the economic model, cost savings were observed over 5 years with an estimated savings of $12,195 per person (95% CI -$21,818 to -$4,790). The model estimated a cost-savings associated with RM strategy in 99% of simulations., Conclusions: These population data support more widespread implementation of RM technology to facilitate better patient outcomes and improve health system efficiency., (Copyright © 2022 Canadian Cardiovascular Society. Published by Elsevier Inc. All rights reserved.)

Background: The STICH Randomized Clinical Trial (Surgical Treatment for Ischemic Heart Failure) demonstrated that coronary artery bypass grafting (CABG) reduced all-cause mortality rates out to 10 years compared with medical therapy alone (MED) in patients with ischemic cardiomyopathy and reduced left ventricular function (ejection fraction ≤35%). We examined the economic implications of these results., Methods: We used a decision-analytic patient-level simulation model to estimate the lifetime costs and benefits of CABG and MED using patient-level resource use and clinical data collected in the STICH trial. Patient-level costs were calculated by applying externally derived US cost weights to resource use counts during trial follow-up. A 3% discount rate was applied to both future costs and benefits. The primary outcome was the incremental cost-effectiveness ratio assessed from the US health care sector perspective., Results: For the CABG arm, we estimated 6.53 quality-adjusted life-years (95% CI, 5.70-7.53) and a lifetime cost of $140 059 (95% CI, $106 401 to $180 992). For the MED arm, the corresponding estimates were 5.52 (95% CI, 5.06-6.09) quality-adjusted life-years and $74 894 lifetime cost (95% CI, $58 372 to $93 541). The incremental cost-effectiveness ratio for CABG compared with MED was $63 989 per quality-adjusted life-year gained. At a societal willingness-to-pay threshold of $100 000 per quality-adjusted life-year gained, CABG was found to be economically favorable compared with MED in 87% of microsimulations., Conclusions: In the STICH trial, in patients with ischemic cardiomyopathy and reduced left ventricular function, CABG was economically attractive relative to MED at current benchmarks for value in the United States., Registration: URL: https://www., Clinicaltrials: gov; Unique identifier: NCT00023595.

Background: Whether the amount of atrial fibrillation (AF) patients experience conveys important prognostic information beyond that provided by the diagnosis of AF is uncertain. The study objective was to assess the dose-response relationship between device-detected AF burden and subsequent cardiovascular outcomes., Methods: Among patients with paroxysmal AF who underwent cardiac implantable electronic device implantation (2010-2016), Merlin.net remote-monitoring data were linked to Medicare claims to assess the magnitude and strength of the associations between device-based AF burden (defined as a daily percentage of time spent in AF or maximal AF episode duration ascertained at baseline over 30 days) and key cardiovascular outcomes., Results: Among 39 710 patients (mean age 77.1±8.7 years, 60.7% male, and a mean CHA 2 DS 2 -VASc score 4.9±1.3), all-cause mortality at 1-year increased with baseline AF burden: 8.54% with AF burden 0%, 8.9% with AF burden 0% to 5%, and 10.9% with AF burden 5% to 98% ( P <0.001) There was also a dose-response relationship between increasing AF burden and all-cause or cardiovascular hospitalization and ischemic stroke. Updating AF burden data every 30 days did not alter the AF burden-prognostic relationships determined from the use of baseline data alone. Results were also consistent when 3-year outcomes were considered and after accounting for the use of oral anticoagulants., Conclusions: In paroxysmal AF, there is a clinically relevant dose-response relationship between increasing AF burden and rates of adverse outcomes at 1- and 3-years, including increasing risks of cardiovascular hospitalization, ischemic stroke, and mortality.

Importance: In the Rehabilitation Therapy in Older Acute Heart Failure Patients (REHAB-HF) trial, a novel 12-week rehabilitation intervention demonstrated significant improvements in validated measures of physical function, quality of life, and depression, but no significant reductions in rehospitalizations or mortality compared with a control condition during the 6-month follow up. The economic implications of these results are important given the increasing pressures for cost containment in health care., Objective: To report the economic outcomes of the REHAB-HF trial and estimate the potential cost-effectiveness of the intervention., Design, Setting, Participants: The multicenter REHAB-HF trial randomized 349 patients 60 years or older who were hospitalized for acute decompensated heart failure to rehabilitation intervention or a control group; patients were enrolled from September 17, 2014, through September 19, 2019. For this preplanned secondary analysis of the economic outcomes, data on medical resource use and quality of life (via the 5-level EuroQol 5-Dimension scores converted to health utilities) were collected. Medical resource use and medication costs were estimated using 2019 US Medicare payments and the Federal Supply Schedule, respectively. Cost-effectiveness was estimated using the validated Tools for Economic Analysis of Patient Management Interventions in Heart Failure Cost-Effectiveness Model, which uses an individual-patient simulation model informed by the prospectively collected trial data. Data were analyzed from March 24, 2019, to December 1, 2020., Interventions: Rehabilitation intervention or control., Main Outcomes and Measures: Costs, quality-adjusted life-years (QALYs), and the lifetime estimated cost per QALY gained (incremental cost-effectiveness ratio)., Results: Among the 349 patients included in the analysis (183 women [52.4%]; mean [SD] age, 72.7 [8.1] years; 176 non-White [50.4%] and 173 White [49.6%]), mean (SD) cumulative costs per patient were $26 421 ($38 955) in the intervention group (excluding intervention costs) and $27 650 ($30 712) in the control group (difference, -$1229; 95% CI, -$8159 to $6394; P = .80). The mean (SD) cost of the intervention was $4204 ($2059). Quality of life gains were significantly greater in the intervention vs control group during 6 months (mean utility difference, 0.074; P = .001) and sustained beyond the 12-week intervention. Incremental cost-effectiveness ratios were estimated at $58 409 and $35 600 per QALY gained for the full cohort and in patients with preserved ejection fraction, respectively., Conclusions and Relevance: These analyses suggest that longer-term benefits of this novel rehabilitation intervention, particularly in the subgroup of patients with preserved ejection fraction, may yield good value to the health care system. However, long-term cost-effectiveness is currently uncertain and dependent on the assumption that benefits are sustained beyond study follow-up, which needs to be corroborated in future trials in this patient population.

Background: Burden of atrial fibrillation (AF), as a continuous measure, is an emerging alternative classification often assumed to increase linearly with progression of disease. Yet there are no descriptions of AF burden distributions across populations., Methods: We examined patterns of AF burden (% time in AF) across 3 different cohorts: outpatients with AF undergoing Holter monitoring in a national registry (ORBIT-AF II), routine outpatients undergoing Holter monitoring in a tertiary healthcare system (UHealth), and patients >= 65 years with cardiac implantable electronic devices (Merlin.net TM linked to Medicare)., Results: We included 2,058 ORBIT-AF II patients, 4,537 UHealth patients, and 39,710 from Merlin.net. Mean age ranged from 56 to 77 years, sex ranged from 40% to 61% male, and mean CHA 2 DS 2 -VASc scores ranged from 2.2 to 4.9. Across all cohorts, AF burden demonstrated skewed frequency towards the extremes, with the vast majority of patients having either very low or very high AF burden. This bimodal distribution was consistent across cohorts, across clinically-documented AF types (paroxysmal v persistent), patients with or without a known AF diagnosis, and among patients with different types of cardiac implantable electronic devices., Conclusions: Across 3 broad, diverse cohorts with continuous monitoring, distribution of AF burden was consistently skewed towards the extremes without an even, linear distribution or progression. As AF burden is increasingly recognized as a descriptor and potential risk-stratifier, these findings have important implications for future research and patient care., (Copyright © 2021 Elsevier Inc. All rights reserved.)

Background: As the prevalence of atrial fibrillation (AF) increases, a greater understanding of the costs associated with AF care is required. While individuals with greater arrhythmic burden may interact with the health system more frequently, the relationship between AF burden and costs remains undefined., Methods: In a longitudinal patient cohort with paroxysmal AF and newly implanted cardiovascular implantable electronic devices (CIED) (2010-2016), we linked CIED remote-monitoring data with Medicare claims to assess the association between the 30-day averaged device-detected daily percentage of time in AF ("AF burden") and healthcare costs., Results: Among 39,345 patients, the mean age was 77.1 ± 8.7 years, 60.7% were male, and the mean CHA 2 DS 2- VASc score was 4.9 ± 1.3. The mean total 1-year costs were $18,668 ± 29,173, driven by hospitalization costs where two-thirds of admissions were due to heart failure. Increasing AF burden was associated with increasing costs: $17,860 ± 28,525 for 0% daily AF burden; $18,840 ± 29,104 for 0-5% daily AF burden; and $20,968 ± 31,228 for 5-98% daily AF burden. There was a linear relationship between AF burden expressed as a continuous variable and 1-year costs (adjusted cost rate ratio 1.031 per 10% daily duration in AF, 95% confidence interval 1.023-1.038; P < .001)., Conclusions: Among older patients with paroxysmal AF and CIEDs, increasing AF burden is associated with higher healthcare costs. As the observational study design is unable to determine causal relationships, prospective study is required to explore the intriguing hypothesis that targeted AF strategies, including comorbidity management, that reduce AF burden may also reduce the high annual costs associated with AF., (Copyright © 2021 Elsevier Inc. All rights reserved.)

Importance: Persistently depressed left ventricular ejection fraction (LVEF) after myocardial infarction (MI) is associated with adverse prognosis and directs the use of evidence-based treatments to prevent sudden cardiac death and/or progressive heart failure., Objective: To assess adherence with guideline-recommended LVEF reassessment and to study the evolution of LVEF over 6 months of follow-up., Design, Setting, and Participants: This was a multicenter cohort study at Canadian academic and community hospitals with on-site cardiac catheterization services. Patients with type 1 acute MI and LVEF less than or equal to 45% during the index hospitalization were enrolled between January 2018 and August 2019 and were followed-up for 6 months. Data analysis was performed from May 2020 to September 2021., Exposures: Baseline clinical factors, in-hospital care and LVEF, and site-specific features., Main Outcomes and Measures: The main outcomes were receipt of repeat LVEF assessment by 6 months and the presence of a persistent LVEF reduction at 2 thresholds: LVEF less than or equal to 40%, prompting consideration of additional medical therapy for heart failure, or LVEF less than or equal to 35%, prompting referral for implanted cardioverter defibrillator in addition to medical therapy., Results: This study included 501 patients (mean [SD] age, 63.3 [13.0] years; 113 women [22.6%]). Overall, 370 patients (73.4%) presented with STEMI, and 454 (90.6%) had in-hospital revascularization. The median (IQR) baseline LVEF was 40% (34%-43%). Of 458 patients (91.4%) who completed the 6-month follow-up, 303 (66.2%; 95% CI, 61.7%-70.5%) had LVEF reassessment, with a range of 46.7% to 90.0% across sites (χ213 = 19.6; P = .11). Participants from community hospitals were more likely than those from academic hospitals to undergo LVEF reassessment (73.6% vs 63.2%; χ21 = 4.50; P = .03), as were those with worse LVEF at baseline. Follow-up LVEF improved by an absolute median (IQR) of 8% (3%-15%). However, 103 patients (34.1%) met the definitions of clinically relevant LVEF reduction, including 52 patients (17.2%) with LVEF less than or equal to 35% and 51 patients (16.9%) with LVEF of 35.1% to 40.0%., Conclusions and Relevance: In this cohort study, approximately 1 in 3 patients with at least mild LVEF reduction after acute MI did not undergo indicated LVEF reassessment within 6 months, suggesting that programs to improve the quality of post-MI care should include measures to ensure that indicated repeat cardiac imaging is performed. In those with follow-up imaging, clinically relevant persistent LVEF reduction was identified in more than one-third of patients.

Background: Cardioneuroablation (CNA) targets the intrinsic cardiac autonomic nervous system ganglionated plexi located in the peri-atrial epicardial fat. There is increasing interest in CNA as a treatment of vasovagal syncope (VVS), despite no randomized clinical trial (RCT) data., Objective: The purpose of this study was to poll the opinion on CNA) for VVS., Methods: A REDCap (Research Electronic Data Capture) survey was administered to international physicians treating patients with VVS on their opinion about patient selection criteria, ablation approach, RCT design, and most appropriate end points for CNA procedures., Results: The survey was completed by 118 physicians; 86% were cardiac electrophysiologists. The majority of respondents (79%) would consider referring a patient with refractory VVS for CNA, and 27% have performed CNA for VVS themselves. Most felt patient selection should require a head-up tilt test with a cardioinhibitory response (67%) and suggest a minimum age of 18 years with a median of 3 (interquartile range 2-5) episodes in the past year. There were differences in patient selection between physicians who have performed CNA themselves and those who have not. The majority felt that the ablation strategy should include both atria (70%) with an anatomical approach in combination with autonomic stimulation (85%). Performing a sham procedure in the control arm was supported by 56% of respondents, providing equipoise in RCT design. The preferred primary outcome was freedom from syncope within 1 year of follow-up., Conclusion: There is widespread support for well-designed RCTs to confirm the hypothesized clinical benefit of CNA, provide data to guide the risk-benefit equations during patient selection, and appropriately estimate the placebo effect., (Copyright © 2021 Heart Rhythm Society. Published by Elsevier Inc. All rights reserved.)

Background: Wait times for catheter ablation in patients with symptomatic atrial fibrillation (AF) may influence clinical outcomes., Objective: This study examined the relationship between the duration from AF diagnosis to ablation, or diagnosis-to-ablation time (DAT), on the clinical response to catheter ablation in a large nationwide cohort of patients., Methods: We identified patients with new AF who underwent catheter ablation between January 2014 and December 2017 using the IBM MarketScan databases. Cox proportional hazard models were used to estimate the strength of the association between DAT and the outcomes of AF recurrence and hospitalization at 1 year postablation., Results: Among 11,143 AF patients who underwent ablation, the median age was 59 years, 31% were female, and the median CHA 2 DS 2 -VASc score was 2. Median DAT was 5.5 (2.6, 13.1) months. At 1 year postablation, 10.0% (n = 1116) developed recurrent AF. For each year increase in DAT, the risk of AF recurrence increased by 20% after adjustment for baseline comorbidities and medications (hazard ratio [HR] 1.20, 95% confidence interval [CI] 1.11-1.30). A longer DAT was associated with an increased risk of hospitalization (HR 1.08 per DAT year, 95% CI 1.02-1.15). DAT was a stronger predictor of AF recurrence postablation than traditional clinical risk factors, including age, prior heart failure, or renal failure., Conclusion: Increasing duration between AF diagnosis and catheter ablation is associated with higher AF recurrence rates and all-cause hospitalization. Our findings are consistent with a growing body of evidence supporting the benefits of prioritizing early restoration of sinus rhythm., (© 2021 Heart Rhythm Society. Published by Elsevier Inc.)