Dynamic risk assessment to improve quality of care in patients with atrial fibrillation: the 7th AFNET/EHRA Consensus Conference.

AIMS: The risk of developing atrial fibrillation (AF) and its complications continues to increase, despite good progress in preventing AF-related strokes. METHODS AND RESULTS: This article summarizes the outcomes of the 7th Consensus Conference of the Atrial Fibrillation NETwork (AFNET) and the European Heart Rhythm Association (EHRA) held in Lisbon in March 2019. Sixty-five international AF specialists met to present new data and find consensus on pressing issues in AF prevention, management and future research to improve care for patients with AF and prevent AF-related complications. This article is the main outcome of an interactive, iterative discussion between breakout specialist groups and the meeting plenary. AF patients have dynamic risk profiles requiring repeated assessment and risk-based therapy stratification to optimize quality of care. Interrogation of deeply phenotyped datasets with outcomes will lead to a better understanding of the cardiac and systemic effects of AF, interacting with comorbidities and predisposing factors, enabling stratified therapy. New proposals include an algorithm for the acute management of patients with AF and heart failure, a call for a refined, data-driven assessment of stroke risk, suggestions for anticoagulation use in special populations, and a call for rhythm control therapy selection based on risk of AF recurrence. CONCLUSION: The remaining morbidity and mortality in patients with AF needs better characterization. Likely drivers of the remaining AF-related problems are AF burden, potentially treatable by rhythm control therapy, and concomitant conditions, potentially treatable by treating these conditions. Identifying the drivers of AF-related complications holds promise for stratified therapy.

Remote-only monitoring for patients with cardiac implantable electronic devices: a before-and-after pilot study.

BACKGROUND: Outcomes for patients with cardiac implantable electronic devices are better when follow-up incorporates remote monitoring technology in addition to in-clinic visits. For patients with implantable devices, we sought to determine the feasibility, safety and associated health care utilization of remote-only follow-up, along with its effects on patients' quality of life and costs. METHODS: This multicentre before-and-after pilot study involved patients with new or existing pacemakers or implantable cardioverter defibrillators. The "before" phase of the study spanned the period October 2015 to February 2017; the "after" phase spanned the period October 2016 to February 2018. The exposure was remote-only follow-up in combination with Remote View, a service that facilitates access to device data, allowing device settings to be viewed remotely to facilitate remote programming. Outcomes at 12 months were feasibility (adherence to remote monitoring), safety (rate of adverse events) and health care utilization (remote and in-clinic appointments). We also assessed quality of life, using 3 validated scales, and costs, taking into account both health care system and patient costs. RESULTS: A total of 176 patients were enrolled. Adherence (defined as at least 1 successful remote transmission during follow-up) was 87% over a mean follow-up of 11.7 (standard deviation 2.2) months. There was a reduction in in-clinic visits at specialized sites among patients with both implantable defibrillators (26 v. 5, p < 0.001, n = 48) and pacemakers (42 v. 10, p < 0.001, n = 51). There was no significant change in visits to community sites for patients with defibrillators (13 v. 17, p = 0.3, n = 48). The composite rate of death, stroke, cardiovascular hospitalization and device-related hospitalization was 7% (n = 164). No adverse events were linked to the intervention. There was no change in quality-of-life scales between baseline and 12 months. Health care costs were reduced by 31% for patients with defibrillators and by 44% for those with pacemakers. INTERPRETATION: This pilot study showed the feasibility of remote-only follow-up, with no increase in adverse clinical outcomes and no effect on quality of life, but with reductions in costs and health care utilization. These results support progression to a larger-scale study of whether superior effectiveness and reduced cost can be achieved, with preservation of safety, through use of remote-only follow-up. TRIAL REGISTRATION: ClinicalTrials.gov, no. NCT02585817.

Is Screening for Atrial Fibrillation and Its Risk Factors Useful and Cost-Effective?

Atrial fibrillation (AF) is a major, preventable cause of stroke, whose prevalence is increasing with the aging of the population. There are safe and effective anticoagulation therapies to prevent stroke and new technologies that can identify AF in asymptomatic individuals. Ongoing research will determine if AF screening is cost-effective and will define the best screening strategies. The effectiveness of AF screening can be enhanced by simultaneously screening for the cardiovascular conditions that predispose to the development and progression of AF and its complications. Future studies evaluating an integrated screening program on outcomes, health care utilization, and cost are needed.

Atrial Arrhythmias in Clinically Manifest Cardiac Sarcoidosis: Incidence, Burden, Predictors, and Outcomes.

Background Recent data have suggested a substantial incidence of atrial arrhythmias (AAs) in cardiac sarcoidosis (CS). Our study aims were to first assess how often AAs are the presenting feature of previously undiagnosed CS. Second, we used prospective follow-up data from implanted devices to investigate AA incidence, burden, predictors, and response to immunosuppression. Methods and Results This project is a substudy of the CHASM-CS (Cardiac Sarcoidosis Multicenter Prospective Cohort Study; NCT01477359). Inclusion criteria were presentation with clinically manifest cardiac sarcoidosis, treatment-naive status, and implanted with a device that reported accurate AA burden. Data were collected at each device interrogation visit for all patients and all potential episodes of AA were adjudicated. For each intervisit period, the total AA burden was obtained. A total of 33 patients met the inclusion criteria (aged 56.1±7.7 years, 45.5% women). Only 1 patient had important AAs as a part of the initial CS presentation. During a median follow-up of 49.1 months, 11 of 33 patients (33.3%) had device-detected AAs, and only 2 (6.1%) had a clinically significant AA burden. Both patients had reduced burden after CS was successfully treated and there was no residual fluorodeoxyglucose uptake on positron emission tomography scan. Conclusions First, we found that AAs are a rare presenting feature of clinically manifest cardiac sarcoidosis. Second, AAs occurred in a minority of patients at follow-up; the burden was very low in most patients. Only 2 patients had clinically significant AA burden, and both had a reduction after CS was treated. Registration URL: https://www.clini​caltr​ials.gov; unique identifier NCT01477359.

Guidance on Minimizing Risk of Drug-Induced Ventricular Arrhythmia During Treatment of COVID-19: A Statement from the Canadian Heart Rhythm Society.

The COVID-19 pandemic has led to efforts at rapid investigation and application of drugs which may improve prognosis but for which safety and efficacy are not yet established. This document attempts to provide reasonable guidance for the use of antimicrobials which have uncertain benefit but may increase risk of QT interval prolongation and ventricular proarrhythmia, notably, chloroquine, hydroxychloroquine, azithromycin, and lopinavir/ritonavir. During the pandemic, efforts to reduce spread and minimize effects on health care resources mandate minimization of unnecessary medical procedures and testing. We recommend that the risk of drug proarrhythmia be minimized by 1) discontinuing unnecessary medications that may also increase the QT interval, 2) identifying outpatients who are likely to be at low risk and do not need further testing (no history of prolonged QT interval, unexplained syncope, or family history of premature sudden cardiac death, no medications that may prolong the QT interval, and/or a previous known normal corrected QT interval [QTc]), and 3) performing baseline testing in hospitalized patients or those who may be at higher risk. If baseline electrocardiographic testing reveals a moderately prolonged QTc, optimization of medications and electrolytes may permit therapy. If the QTc is markedly prolonged, drugs that further prolong it should be avoided, or expert consultation may permit administration with mitigating precautions. These recommendations are made while there are no known effective treatments for COVID-19 and should be revisited when further data on efficacy and safety become available.

Impact of Cardiac Implantable Electronic Device Infection: A Clinical and Economic Analysis of the WRAP-IT Trial.

BACKGROUND: Current understanding of the impact of cardiac implantable electronic device (CIED) infection is based on retrospective analyses from medical records or administrative claims data. The WRAP-IT (Worldwide Randomized Antibiotic Envelope Infection Prevention Trial) offers an opportunity to evaluate the clinical and economic impacts of CIED infection from the hospital, payer, and patient perspectives in the US healthcare system. METHODS: This was a prespecified, as-treated analysis evaluating outcomes related to major CIED infections: mortality, quality of life, disruption of CIED therapy, healthcare utilization, and costs. Payer costs were assigned using medicare fee for service national payments, while medicare advantage, hospital, and patient costs were derived from similar hospital admissions in administrative datasets. RESULTS: Major CIED infection was associated with increased all-cause mortality (12-month risk-adjusted hazard ratio, 3.41 [95% CI, 1.81-6.41]; P<0.001), an effect that sustained beyond 12 months (hazard ratio through all follow-up, 2.30 [95% CI, 1.29-4.07]; P=0.004). Quality of life was reduced (P=0.004) and did not normalize for 6 months. Disruptions in CIED therapy were experienced in 36% of infections for a median duration of 184 days. Mean costs were $55 547±$45 802 for the hospital, $26 867±$14 893, for medicare fee for service and $57 978±$29 431 for Medicare Advantage (mean hospital margin of -$30 828±$39 757 for medicare fee for service and -$6055±$45 033 for medicare advantage). Mean out-of-pocket costs for patients were $2156±$1999 for medicare fee for service, and $1658±$1250 for medicare advantage. CONCLUSIONS: This large, prospective analysis corroborates and extends understanding of the impact of CIED infections as seen in real-world datasets. CIED infections severely impact mortality, quality of life, healthcare utilization, and cost in the US healthcare system. Registration: URL: https://www.clinicaltrials.gov Unique Identifier: NCT02277990.

Wearable and implantable diagnostic monitors in early assessment of atrial tachyarrhythmia burden.

Atrial fibrillation (AF) is the cause of substantial direct patient morbidity and a frequent cause of emergency room visits. Even when asymptomatic, AF remains a major cause of stroke, particularly among the elderly. As the risk of both AF and stroke increase with age, the importance of AF-related stroke is growing as a result of demographic shifts in many countries. Oral anticoagulation is highly effective at preventing stroke due to AF; however, AF remains undetected in a large number of individuals. The last decade has witnessed the development of many new technologies to detect AF. Screening studies using single-time point or repeated discrete screening methods have uncovered previously undiagnosed AF in 1-3% of asymptomatic individuals. However, continuous monitoring with implanted devices demonstrates short-lasting AF in over one-third of older individuals with cardiovascular risk factors. Debate remains regarding the minimum burden of AF that is associated with an increase in stroke risk, and the threshold for using oral anticoagulation. Over the next 5 years, ongoing studies will help clarify how wearable and implantable technology can be used to improve outcomes in patients with previously unrecognized AF.

Descriptive analysis of pharmacy services provided after community pharmacy screening.

Background Community pharmacies are promising locations for opportunistic screening due to pharmacist accessibility and ability to perform various health and medication management services. Little is known as to the provision of pharmacy services following screening initiatives. Objective To describe provision of pharmacy services for participants following a community pharmacy stroke screening initiative. Setting The Program for the Identification of "Actionable Atrial" Fibrillation Pharmacy initiative took place in 30 pharmacies in Alberta and Ontario, Canada. 1149 participants ≥ 65 were screened for atrial fibrillation, type 2 diabetes, and hypertension. Method Retrospective, secondary analysis of data using participant case-report forms, pharmacy data, and pharmacy claims to describe pharmacy services received by participants post-screening. Main Outcome Measure Number and types of remunerated pharmacy services received by participants post-screening. Results A total of 535/1149 (46.6%) participants screened at their regular pharmacy were included in this analysis. Of these, 165 (30.8%) participants received 229 pharmacy services within 3 months post-screening, including 146 medication reviews, 57 influenza vaccinations, and 21 pharmaceutical opinions. A median (interquartile range, IQR) of 6 (2-11) pharmacy services were delivered, and median (IQR) reimbursement was $187.50 ($67.50-$342.50). Conclusions Approximately one-third of participants received a pharmacy service within 3 months post-screening. Relatively large numbers of annual and follow-up medication reviews were delivered despite low eligibility for annual-only reviews and despite many missed opportunities for pharmacy service provision in at-risk patients. In-pharmacy screening may facilitate provision of some services, namely medication reviews, by providing opportunities to identify patients at-risk.

The Guideline-Policy Gap in Direct-Acting Oral Anticoagulants Usage in Atrial Fibrillation: Evidence, Practice, and Public Policy Considerations.

Atrial fibrillation has a high disease burden-both in prevalence and associated consequences. Despite anticoagulation being an effective treatment in atrial fibrillation, stroke prevention is slow to reflect evidence-based practice. Real-world data reveal a substantial portion of patients who would benefit from anticoagulation, yet do not receive it adequately or at all. A large part of this suboptimal treatment is due to the underutilization of direct oral anticoagulants (DOACs). In response to abundant evidence published over a short timeframe, international guidelines have adopted DOAC usage ahead of policy and fund holders. This paper reviews the evidence and values that influence published guidelines, patient-physician decision making, and policy framework on DOAC usage. An important factor is the access gap between patients who qualify for DOAC according to evidence-based guidelines and the subset of this cohort who are eligible for DOAC based on government funded policy. We analyse the Canadian health system in detail-including drug approval and funding process. Health care systems in other countries are explored, with emphasis on similar universal health care systems that may help overcome barriers common to Canada. We will discuss strategies to: (1) improve awareness of the risk and preventability of stroke; (2) enable physicians to provide evidence-based DOAC usage; (3) empower patients to improve adherence and persistence; (4) collect real-life data that encourages patient self-monitoring, physician outcomes auditing, and building evidence that is useful for policy makers; and (5) use postmarketing data in negotiating shared risk management between pharmaceuticals and government to improve access to DOACs.

Screening for atrial fibrillation in Canadian pharmacies: an economic evaluation.

BACKGROUND: Screening for undiagnosed atrial fibrillation may lead to treatment with oral anticoagulation therapy, which can decrease the risk of ischemic stroke. The objective of this study was to conduct an economic evaluation of the Program for the Identification of 'Actionable' Atrial Fibrillation in the Pharmacy Setting (PIAAF-Pharmacy), which screened 1145 participants aged 65 years or more at 30 community pharmacies in Ontario and Alberta between October 2014 and April 2015. METHODS: We used a 2-part decision model to evaluate the short- and long-term costs and quality-adjusted life-years (QALYs) of a pharmacy screening program for atrial fibrillation compared to no screening. Data from the PIAAF-Pharmacy study were used for the short-term model, and the relevant literature was used to extrapolate the benefits of the PIAAF-Pharmacy study in the long-term model. Costs and QALYs were calculated from a payer perspective over a lifetime horizon and were discounted at 1.5%/year. RESULTS: Screening for atrial fibrillation in pharmacies was associated with higher costs ($26) and more QALYs (0.0035) compared to no screening, yielding an incremental cost per QALY gained of $7480. Univariate and probabilistic sensitivity analyses confirmed that screening for atrial fibrillation in a pharmacy setting was a cost-effective strategy. INTERPRETATION: Our results support screening for atrial fibrillation in Canadian pharmacies. Given this finding, efforts should be made by provincial governments and pharmacies to implement such programs in Canada. The addition of atrial fibrillation screening alongside screening and management of other cardiovascular conditions may help to reduce the burden of stroke.

Cost-effectiveness of catheter ablation for rhythm control of atrial fibrillation.

Objective. The objective of this study is to evaluate the cost-effectiveness of catheter ablation for rhythm control compared to antiarrhythmic drug (AAD) therapy in patients with atrial fibrillation (AF) who have previously failed on an AAD. Methods. An economic model was developed to compare (1) catheter ablation and (2) AAD (amiodarone 200 mg/day). At the end of the initial 12 month phase of the model, patients are classified as being in normal sinus rhythm or with AF, based on data from a meta-analysis. In the 5-year Markov phase of the model, patients are at risk of ischemic stroke each 3-month model cycle. Results. The model estimated that, compared to the AAD strategy, ablation had $8,539 higher costs, 0.033 fewer strokes, and 0.144 more QALYS over the 5-year time horizon. The incremental cost per QALY of ablation compared to AAD was estimated to be $59,194. The probability of ablation being cost-effective for willingness to pay thresholds of $50,000 and $100,000 was estimated to be 0.89 and 0.90, respectively. Conclusion. Based on current evidence, pulmonary vein ablation for treatment of AF is cost-effective if decision makers willingness to pay for a QALY is $59,194 or higher.

The burden of atrial fibrillation on the hospital sector in Canada.

BACKGROUND: Atrial fibrillation (AF) is a common disease that frequently requires acute hospital care; however, the cost of hospital care in Canada has not been reported. The purpose of this study was to estimate the cost of AF related to hospital-based care in Canada. METHODS: Analyses were conducted with 2 national administrative databases for the fiscal year 2007-2008. Databases included information for hospital admissions, day operations, and ambulatory care. Records with a most responsible diagnosis of AF, atrial flutter, or a diagnosis related to AF with a concomitant comorbidity of AF were included. Hospital costs were estimated, in 2010 Canadian dollars, by applying an average cost per weighted case to the resource intensity weight for each admission or visit and then adding the separate billable fee for admissions, surgical procedures, and interventions. RESULTS: In 2007-2008, the number of acute care admissions with AF as the most responsible diagnosis was 22,823, same-day surgical procedures was 5707, and emergency department visits was 58,066. The hospital costs attributable to AF were $815 million in 2010 Canadian dollars: $710 million for hospitalizations; $32 million for same-day surgical procedures; and $73 million for emergency department visits. Most of the acute care costs were for hospitalizations when AF was listed as a comorbidity ($558 million, or 69%). CONCLUSION: AF results in a substantial cost burden to the acute care hospital sector. Current hospital costs in AF patients are driven by the consequences of AF, while the costs for specific treatments for AF are relatively low.

Canadian Registry of ICD Implant Testing procedures (CREDIT): current practice, risks, and costs of intraoperative defibrillation testing.

BACKGROUND: There is uncertainty about the proper role of defibrillation testing (DT) at the time of implantable cardioverter defibrillator (ICD) insertion. METHODS: A prospective registry was conducted at 13 sites in Canada between January 2006 and October 2007. OBJECTIVES: To document the details of DT, the reasons for not conducting DT, and the costs and complications associated with DT. RESULTS: DT was conducted at implantation in 230 of 361 patients (64%). DT was more likely to be conducted for new implants compared with impulse generator replacements (71% vs 32%, P = 0.0001), but was similar for primary and secondary prevention indications (64% vs 63%, P = NS). Among patients not having DT, the reason(s) given were: considered unnecessary (44%); considered unsafe, mainly due to persistent atrial fibrillation (37%); lack of an anesthetist (20%); and, patient or physician preference (6%). When performed, DT consisted of a single successful shock > or = 10J below maximum device output in 65% of cases. A 10J safety-margin was met by 97% of patients, requiring system modification in 2.3%. Major perioperative complications occurred in 4.4% of patients having DT versus 6.6% of patients not having DT (P = NS). ICD insertion was $844 more expensive for patients having DT (P = 0.16), largely due to increased costs ($28,017 vs $24,545) among patients having impulse generator replacement (P = 0.02). CONCLUSIONS: DT was not performed in a third of ICD implants, usually due to a perceived lack of need or relative contraindication.

Cost-effectiveness of physiologic pacing: results of the Canadian Health Economic Assessment of Physiologic Pacing.

OBJECTIVES: The purpose of this study was to determine the cost-effectiveness of physiologic pacemakers. BACKGROUND: The Canadian Trial of Physiologic Pacing (CTOPP) was a large randomized trial that evaluated the efficacy of physiologic pacing compared with ventricular pacing. CTOPP also included a prospective cost-effectiveness substudy. METHODS: Resource usage and costs were collected from a subset of 472 patients (of 1,094) who received a physiologic pacemaker and 586 (of 1,474) who received a ventricular pacemaker. Costs included initial pacemaker implantation and all health care follow-up costs over a follow-up of 5.2 years. Costs are reported in 2004 Canadian dollars (1 Canadian dollar = 0.76 US dollars), with adjustments for censoring. Incremental cost-effectiveness was estimated as the ratio of the difference (treatment-control) in mean cost to the difference in life expectancy (mean survival), with costs and effects discounted at 3% per year. RESULTS: Over a mean follow-up of 3.1 years, physiologic pacing was associated with a gain of 0.01 life-years. This benefit increases to 0.25 life-years in the subgroup of patients with an intrinsic (unpaced) heart rate < or =60 bpm. Physiologic pacing was more expensive than ventricular (16,833 Canadian dollars vs 13,857 US dollars), largely because of the increased cost of dual-chamber devices. Among all substudy patients, the incremental cost-effectiveness of physiologic pacing is 297,600 Canadian dollars per life-year gained; however, this value falls to 16,343 Canadian dollars in patients with an intrinsic heart rate >60. CONCLUSIONS: In the short term, a strategy of routine implantation of physiologic pacemakers is not cost-effective by currently accepted standards. The selective use of these devices in patients likely to be pacemaker dependent appears to be cost-effective. Further studies with longer follow-up and which consider the benefit of reducing nonfatal cardiac events would be valuable.