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In patients with atrial fibrillation (AF) treated with direct oral anticoagulants (DOAC), bleeding risk scores provide only modest discrimination for major or intracranial bleeding. However, warfarin experience may impact HAS-BLED (Hypertension, Abnormal renal/liver function, Stroke, Bleeding history or predisposition, Labile international normalized ratio, Elderly (65 years), Drugs/alcohol concomitantly) score performance in patients evaluated for DOACs, as HAS-BLED was derived and validated in warfarin cohorts.We performed a retrospective cohort study of patients prescribed DOAC for AF in the Veterans Health Administration between 2010 and 2017. We determined modified HAS-BLED score discrimination and calibration for bleeding, for patients treated with DOAC, stratified by prior warfarin exposure. We also determined the association between DOAC-warfarin-naïve status to bleeding (nonintracranial and intracranial) with DOAC-warfarin-experienced patients as reference.The DOAC analysis cohort included 100, 492 patients with AF (age [mean ± SD]: 72.9 ± 9.6 years; 1.7% female; 90.1% White), of which 26, 760 patients (26.6%) and 73, 732 patients (73.4%) were warfarin experienced or naïve, respectively. HAS-BLED discrimination for bleeds was modest for patients treated with DOAC, regardless of prior warfarin experience (concordance statistics: 0.53-0.59). For DOAC-warfarin-naïve patients, as compared to DOAC-warfarin-experienced patients, adjusted risk of intracranial bleeding was lower, while risk of nonintracranial bleeding was higher (intracranial bleeding propensity adjusted with inverse probability of treatment weights [IPTWs]: hazard ratio [HR]: 0.86, 95% confidence interval [CI]: 0.78-0.95, p = .0040) (nonintracranial bleeding propensity adjusted with IPTW: HR: 1.15, 95% CI: 1.11-1.19, p .0001).Patients' modified HAS-BLED score at the time of DOAC initiation, regardless of prior warfarin use, provided only modest discrimination for intracranial and nonintracranial bleeds. These data argue against maintaining DOAC eligible patients on warfarin therapy regardless of modified HAS-BLED score.

Optimal stroke prevention strategies for patients with atrial fibrillation (AF) who experience a major bleed are poorly defined. We sought to estimate the effectiveness and safety of oral anticoagulation (OAC) represcription after an OAC contraindication. TREAT-AF is a retrospective cohort study of patients with newly diagnosed AF (2004–2012), treated in the Veterans Health Administration. From this cohort, we identified patients with a contraindication to OAC after AF diagnoses, defined as incident intracranial bleeding, non-intracranial bleeding requiring hospitalization, or unrepaired cerebral aneurysm or aortic dissection. We used multivariate Cox proportional hazards to estimate the association of OAC prescription in the 90 days following OAC contraindication to ischemic stroke and rebleeding. Among 167,190 patients with newly diagnosed AF (70 ± 11 years, 1.7% female, CHA2DS2-VASc 2.7 ± 1.7), 19,285 patients (11.5%) had an incident bleed (n = 18,342) or an unrepaired cerebral aneurysm or aortic dissection (n = 943). For OAC-contraindicated patients with a CHA2DS2-VASc ≥2 (N = 16,194), OAC was represcribed in 4075 patients (25%) and was associated with a higher risk of non-intracranial bleeding (HR 1.49; 95% CI 1.37–1.61; p

Ty J. Gluckman, MD, FACC, Chair Niti R. Aggarwal, MD, FACC Nicole M. Bhave, MD, FACC Gregory J. Dehmer, MD, MACC Olivia N. Gilbert, MD, MSc, FACC Chayakrit Krittanawong, MD Dharam J. Kumbhani, MD, SM, FACC Javier A. Sala-Mercado, MD, PhD Andrea L. Price, CPHQ, RCIS, AACC David E.

Background Reduced time in international normalized ratio therapeutic range (TTR) limits warfarin safety and effectiveness. In patients switched from warfarin to direct oral anticoagulants (DOACs), patient factors associated with low TTR could also increase risk of DOAC nonadherence. We investigated the relationship between warfarin TTR and DOAC adherence in warfarin‐treated patients with atrial fibrillation switched to DOAC. Methods and Results Using data from the Veterans Health Administration, we identified patients with atrial fibrillation switched from warfarin to DOAC (switchers) or treated with warfarin alone (non‐switchers). Logistic regression was used to evaluate association between warfarin TTR and DOAC adherence. We analyzed 128 605 patients (age, 71±9; 1.6% women; CHA 2 DS 2 ‐VASc 3.5±1.6); 32 377 switchers and 96 228 non‐switchers. In 8016 switchers with international normalized ratio data to calculate 180‐day TTR before switch, TTR was low (median 0.45; IQR, 0.26–0.64). Patients with TTR P P Conclusions In patients with atrial fibrillation switched from warfarin to DOAC, most achieved adequate DOAC adherence despite low pre‐switch TTRs. However, TTR trajectories remained low in non‐switchers. Patients with low warfarin TTR more consistently achieved treatment targets after switching to DOACs, although adherence‐oriented interventions may be beneficial.

Ventricular outflow is a common site for idiopathic PVCs and repetitive ventricular arrhythmias. Sites of origin of these arrhythmias may vary from the sites of earliest activation mapped. Better definition of the site of origin can help avoid unnecessary large volume ablation to suppress these arrhythmia.

Background: When presenting for atrial fibrillation (AF) ablation, women, compared with men, tend to have more nonpulmonary vein triggers and advanced atrial disease. Whether this informs differences in AF ablation strategy is not well described. We aimed to characterize ablation strategy and complications by sex, using the Get With The Guidelines-AF registry. Methods: From the Get With The Guidelines-AF registry ablation feature, we included patients who underwent initial AF ablation procedure between January 7, 2016, and December 27, 2019. Patients were stratified based on AF type (paroxysmal versus nonparoxysmal) and sex. We compared patient demographics, ablation strategy, and complications by sex. Results: Among 5356 patients from 31 sites who underwent AF ablation, 1969 were women (36.8%). Women, compared with men, were older (66.8±9.6 versus 63.4±10.6, P P P =0.0002; inferior mitral isthmus line: 10.2% versus 7.0%, P =0.01; floor line: 46.1% versus 40.6%, P =0.02) than in men. In multivariable analysis, the association between patient sex and complications from ablation was not statistically significant. Conclusions: In this US wide AF ablation quality improvement registry, women with nonparoxysmal AF were more likely to receive adjunctive lesion sets compared with men. These findings suggest that patient sex may inform ablation strategy in ways that may not be strongly supported by evidence and emphasize the need to clarify optimal ablation strategies by sex.

Background: Consensus statements have recommended against the use of direct oral anticoagulants (DOACs) in venous thromboembolism (VTE) for patients ≥120 kg and ≥40 kg/m 2 . We sought to determine use and outcomes of DOACs for VTE across weight and body mass index (BMI). Methods: We performed a retrospective cohort study of patients with first-time VTE 2013 to 2018 that were treated with DOAC or warfarin in the Veterans Health Administration. The Veterans Health Administration has implemented system-wide guidance for patient selection and shared decision-making for use of DOACs in VTE at extremes of weight. We stratified patients by weight and BMI and assessed (1) association of weight and BMI category to outcomes in those prescribed DOAC; and (2) association of DOAC, as compared to warfarin, to outcomes by weight and BMI categories. Outcomes of interest included major bleeding, clinically relevant nonmajor bleeding, and recurrent VTE. Results: The analysis cohort included 51 871 patients prescribed DOAC or warfarin within 30 days of index VTE diagnosis (age 64.5±13.1 years; 6.0% female; median weight 93.4 kg [25th–75th: 80.5–108.6 kg]). For patients ≥120 kg (N=6934 patients), 38.4% were treated with DOAC, as compared to 45.4% of those ≥60 to P Conclusions: Patients ≥120 kg and ≥40 kg/m 2 with VTE are frequently prescribed DOAC by the Veterans Health Administration, without an increase in bleeding or recurrent VTE. These findings suggest DOACs can be safe and effective in this population and may argue for broader adoption of pharmacy policies that promote careful patient selection and shared decision making.

Background: Direct oral anticoagulants (DOACs) have strict dosing guidelines, but recent studies indicate that inappropriate dosing is common, particularly in chronic kidney disease (CKD), for which it has been reported to be as high as 43%. Since 2011, the Veterans Health Administration (VA) has implemented anticoagulation management programs for DOACs, generally led by pharmacists, which has previously been shown to improve medication adherence. Objective: We investigated the prevalence of overdosing and underdosing of DOACs in the VA. Methods: Using data from the TREAT-AF cohort study (The Retrospective Evaluation and Assessment of Therapies in AF), we identified VA patients with newly diagnosed atrial fibrillation (AF) and receipt of a DOAC between 2003 and 2015. We classified dosing as correct, overdosed, or underdosed based on the Food and Drug Administration–approved dosing criteria. Results: Of 230 762 patients, 5060 received dabigatran (77.3%) or rivaroxaban (22.7%) within 90 days of AF diagnosis (age 69 [10[ years; CHA2DS2-VASc 1.6 [1.4]), of which 1312 (25.9%) had CKD based on estimated glomerular filtration rate Conclusion: Compared to recent studies of commercial payers and health-care systems, incorrect dosing of DOACs is less common across the VA. Pharmacist-led DOAC management or similar anticoagulation management interventions may reduce the risk of incorrect dosing across health-care systems.

Background and Purpose Magnetic resonance imaging (MRI) is safe for most patients with cardiovascular implantable electronic devices (CIEDs). However, patients presenting with acute ischemic stroke or transient ischemic attack (AIS/TIA) who have CIEDs may undergo MRI less frequently than patients without devices. We assessed contemporary use of MRI for patients with AIS/TIA and the effect of a recent coverage revision by the Center for Medicare and Medicaid Services (CMS) on MRI utilization. Methods Using Optum® claims data from January 2012 to June 2019, we performed an interrupted time series analysis of MRI utilization during AIS/TIA hospitalizations with the April 2018 CMS coverage revision serving as the intervention. For patients treated after the coverage revision, we used multivariable logistic regression to determine the association between lack of CIED and MRI utilization for AIS/TIA. Results We identified 417,899 patient hospitalizations for AIS/TIA, of which 30,425 (7%) had a CIED present (CIED vs non-CIED patients: age 77.6 ± 9.8 vs 72.7 ± 12.3 years; 45.5% vs 54.3% female). From 2012 to 2019, annual MRI utilization increased from 3% to 20% for CIED patients and 58% to 66% for non-CIED patients. The CMS coverage revision was associated with a 4.2% absolute additional increase in MRI utilization for CIED patients. Non-CIED patients treated after the CMS coverage revision were substantially more likely than CIED patients to undergo MRI (adjusted OR 6.7, 95% CI: 6.3-7.1, PConclusions MRI utilization has increased for stroke patients with CIEDs but remains far lower than in similar patients without devices.

The Get With The Guidelines - Atrial Fibrillation (GWTG-AFIB) Registry uses achievement and quality measures to improve the care of patients with atrial fibrillation (AF). We sought to evaluate overall and site-level variation in attainment of these measures among sites participating in the GWTG-AFIB Registry.From the GWTG-AFIB registry, we included patients with AF admitted between 1/3/2013 and 6/30/2019. We described patient-level attainment and variation in attainment across sites of 6 achievement measures with 1) defect-free scores (percent of patients with all eligible measures attained), and 2) composite opportunity scores (percent of all eligible patient measures attained). We also described attainment of 11 quality measures at the patient-level.Among 80,951 patients hospitalized for AF (age 70±13 years, 47.0% female; CHADespite high overall attainment of care measures across GWTG-AFIB registry sites, large site variation was present with meaningful opportunities to improve AF care beyond OAC prescription, including but not limited to prescription of aldosterone antagonists in those with AF and systolic dysfunction and avoidance of non-indicated adjunctive antiplatelet therapy.

Introduction: Magnetic resonance imaging (MRI) has historically been contraindicated for patients with MRI non-conditional (i.e. legacy) cardiac implantable electronic devices (CIED). Recent trials have demonstrated safety of MRI in legacy CIED patients, with the Center for Medicare & Medicaid Services (CMS) revising MRI coverage to include these patients in 4/2018. We sought to determine the effect of this policy change on MRI utilization for legacy CIED patients with acute ischemic stroke or transient ischemic attack (AIS/TIA) and contemporary use of MRI for these patients. Methods: We performed an interrupted time series analysis of MRI utilization for AIS/TIA patients with the CMS MRI coverage revision for legacy CIED patients serving as the intervention. Using Optum claims data from 1/2012 to 7/2019, we identified AIS/TIA hospitalizations and CIED implantations and interrogations using ICD-9/10 and CPT codes, respectively. The intervention’s effect on MRI utilization for AIS/TIA was determined for patients with and without CIEDs separately. For patients treated after the CMS coverage revision, we used multivariable logistic regression to determine the association between lack of CIED and MRI utilization for AIS/TIA. Results: We identified 417,899 patients hospitalized for AIS/TIA, of which 30,425 patients (7%) had a CIED (CIED patients: age 78.0 ±10.2 years, 45% female; non-CIED patients: age 74.1 ±11.8 years, 55% female). From 2012 to 2019, MRI utilization for AIS/TIA increased from 3% to 20% for CIED patients and 58% to 66% for non-CIED patients. The CMS coverage revision was associated with a 4.2% absolute (25% relative) additional increase in MRI utilization for CIED patients with AIS/TIA. In multivariable regression, non-CIED patients treated after the CMS coverage revision, as compared to CIED patients, were substantially more likely to undergo MRI for AIS/TIA (adjusted OR 6.7, 95% CI: 6.3-7.1, p Conclusions: Despite an increase in MRI utilization for AIS/TIA patients with CIEDs attributable to the CMS coverage revision and trials demonstrating safety, a large disparity in use of MRI for AIS/TIA patients with CIEDs persists. Identification and resolution of barriers to appropriate MRI use in AIS/TIA patients with CIEDs are needed.

Background Kidney function may promote progression of AF. Objective We evaluated the association of kidney function to AF progression and resultant clinical outcomes in patients with cardiac implantable electronic devices (CIED). Methods We performed a retrospective cohort study using national clinical data from the Veterans Health Administration linked to CIED data from the Carelink® remote monitoring data warehouse (Medtronic Inc, Mounds View, MN). All devices had atrial leads and at least 75% of remote monitoring transmission coverage. Patients were included at the date of the first AF episode lasting ≥6 minutes, and followed until the occurrence of persistent AF in the first year, defined as ≥7 consecutive days with continuous AF. We used Cox regression analyses with persistent AF as a time-varying covariate to examine the association to stroke, myocardial infarction, heart failure and death. Results Of, 10,323 eligible patients, 1,771 had a first CIED-detected AF (mean age 69 ± 10 years, 1.2% female). In the first year 355 (20%) developed persistent AF. Kidney function was not associated with persistent AF after multivariable adjustment including CHA2DS2-VASc variables and prior medications. Only higher age increased the risk (HR: 1.37 per 10 years; 95% CI:1.22-1.54). Persistent AF was associated to higher risk of heart failure (HR: 2.27; 95% CI: 1.88-2.74) and death (HR: 1.60; 95% CI: 1.30-1.96), but not stroke (HR: 1.28; 95% CI: 0.62-2.62) or myocardial infarction (HR: 1.43; 95% CI: 0.91-2.25). Conclusion Kidney function was not associated to AF progression, whereas higher age was. Preventing AF progression could reduce the risk of heart failure and death.

Introduction: Direct oral anticoagulants (DOAC) are guideline-recommended over warfarin for stroke prevention in atrial fibrillation (AF). However, patients who are DOAC eligible are commonly maintained on warfarin. We sought to evaluate bleeding risk and prediction while on DOAC treatment (both for warfarin-naïve and -experienced patients) as compared to warfarin. Methods: We performed a retrospective cohort study using data from the Veteran Affairs health care system. We included patients with a prescription for warfarin and/or DOAC from 10/1/2010 to 9/30/2017 with an AF encounter in the 90 days prior to 30 days after prescription. We categorized DOAC treated patients as warfarin-naïve or -experienced and performed an on-treatment analysis to determine bleeding incidence and HAS-BLED score discrimination. In adjusted analyses, we compared risk of bleeding while treated with DOAC (both for warfarin-naïve and -experienced patients) to warfarin. Results: The analysis cohort included 99,143 patients treated with warfarin (71±10 years, HAS-BLED 2.6±1.2) and 73,732 and 26,760 patients treated with DOAC who were warfarin-naïve (74±10 years, HAS-BLED 2.4±1.0) and -experienced (71±9 years, HAS-BLED 2.8±1.1), respectively. DOAC patients with warfarin experience had more prior bleeds (DOAC, warfarin-experienced: 11.9%; DOAC, warfarin-naïve: 4.5%; warfarin: 6.2%; pTable ). HAS-BLED discrimination for bleeding outcomes, intracranial or any bleeding, was modest ( Table ). Conclusion: DOAC treatment had a favorable safety profile compared to warfarin treatment, even for DOAC treated patients with warfarin-experience who had more prior bleeds. These data argue against maintaining DOAC eligible patients on warfarin therapy regardless of HAS-BLED score.

Introduction: In seminal trials of venous thromboembolism (VTE) treatment with direct oral anticoagulants (DOAC), few patients were enrolled at low and high body weights to estimate treatment effects in these subgroups. Consensus statements have recommended against use of DOACs in VTE for patients ≥120 kg. We sought to describe real-world use of DOACs and other anticoagulants for VTE across the weight spectrum. Methods: We performed a retrospective cohort study of patients with first-time VTE that were treated with anticoagulants in the VA health care system from 2008 to 2018. We excluded patients with 1) additional indications for anticoagulation (atrial fibrillation and mechanical valves) and 2) no documented weight in the 90 days prior to 90 days after index VTE. We stratified patients by weight ( Results: After excluding 3,676 patients with missing weight, there were 111,774 patients with VTE (64±13 years, 6% female). The most common therapy was warfarin (66%), followed by DOAC (21%), and LMWH/F only (13%). Median weight was 92 kg (interquartile range: 28), with 13,753 patients (12%) with weight ≥120 kg. Across weight categories, proportion of patients receiving DOAC was similar. In patients ≥120 kg, after multivariate adjustment, multiple comorbidities were associated with warfarin prescription while chronic kidney disease was associated with DOAC prescription ( Table ). Conclusion: Weight ≥120 kg is common for VTE patients, with DOAC frequently prescribed despite consensus statements recommending DOAC avoidance. For patients ≥120 kg, comorbidities influence VTE treatment selection, and determination of optimal treatment strategies across the spectrum of comorbidities is needed.

Introduction: Ventricular arrhythmia (VA) mechanisms arising from the crux, summit, and epicardium are often not accessible from the endocardium. The 3.3Fr multipolar mapping catheters (3FMC) (Map-iT, Access Point Technologies, Rogers, MN) can be used to map deep within the coronary sinus (CS) branches and other locations difficult to access with standard catheters. Objective: We present a case series of and techniques for VA ablations guided by the 3FMC. Methods: We retrospectively reviewed VA ablations at 3 centers to describe the utility of the 3FMC in diagnosis and ablation of the arrhythmia. Results: We reviewed 33 patients who underwent VA ablations guided by the 3FMC. Patients (age 59.0 ± 15.4 years, 72% male, LVEF 41.5 ± 10.3%, 93% non-ischemic) had ventricular tachycardia (32%) or high-burden PVCs (68%). The 3FMC was used to interrogate the epicardium via the coronary sinus branches allowing interrogation of the LV crux (Fig. A) and LV summit (Fig. B). Early potentials in the poster-septal branch of CS guided alcohol ablation to focal site in septum not reachable by traditional catheters. Continuous signal on the 3FMC in the posterolateral branch of CS elucidated microreentry and guided more extensive epicardial ablation. Overall, the 3FMC measured signals 18.7 ± 11.3ms early and diagnosed 75% focal, 10% micro-reentrant, and 15% macro-reentrant VAs. Ablation was successful in 76% of cases. Conclusions: High definition mapping with the 3FMC allows diagnosis of VA mechanisms in locations not easily reachable by traditional catheters. Improved mapping of the CS branches enables interrogation and ablation planning of epicardial, summit, and crux VAs and may increase the likelihood of successful VA ablation.

This cross-sectional study evaluates the characteristics and expected strength of evidence of coronavirus disease 2019 studies registered on ClinicalTrials.gov.

Optimal stroke prevention strategies for patients with atrial fibrillation (AF) who experience a major bleed are poorly defined. We sought to estimate the effectiveness and safety of oral anticoagulation (OAC) represcription after an OAC contraindication.TREAT-AF is a retrospective cohort study of patients with newly diagnosed AF (2004-2012), treated in the Veterans Health Administration. From this cohort, we identified patients with a contraindication to OAC after AF diagnoses, defined as incident intracranial bleeding, non-intracranial bleeding requiring hospitalization, or unrepaired cerebral aneurysm or aortic dissection. We used multivariate Cox proportional hazards to estimate the association of OAC prescription in the 90 days following OAC contraindication to ischemic stroke and rebleeding.Among 167,190 patients with newly diagnosed AF (70 ± 11 years, 1.7% female, CHADevelopment of contraindication to OAC after diagnosis of AF is common (11.5%), with most events requiring hospitalization. OAC reinitiation was associated with non-intracranial bleeding risk, with a trend toward reduced stroke risk. These data suggest that stroke prevention approaches after major bleeding events could be beneficial if bleeding risk can be successfully mitigated.

For arrhythmias compatible with a fascicular dependent mechanism, meticulous fascicular potential mapping is required for definitive diagnosis and successful treatment.

BACKGROUND: Atrial fibrillation (AF) is treated by many types of physician specialists, including primary care physicians (PCPs). Health plans have different policies for how patients encounter these providers, and these may affect selection of AF treatment strategy. HYPOTHESIS: We hypothesized that healthcare plans with PCP‐gatekeeping to specialist access may be associated with different pharmacologic treatments for AF. METHODS: We performed a retrospective cohort study using a commercial pharmaceutical claims database. We utilized logistic regression models to compare odds of prescription of oral anticoagulant (OAC), non‐vitamin K‐dependent oral anticoagulant (NOAC), rate control, and rhythm control medications used to treat AF between patients with PCP‐gated healthcare plans (eg, HMO, EPO, POS) and patients with non‐PCP‐gated healthcare plans (eg, PPO, CHDP, HDHP, comprehensive) between 2007 and 2012. We also calculated median time to receipt of therapy within 90 days of index AF diagnosis. RESULTS: We found similar odds of OAC prescription at 90 days following new AF diagnosis in patients with PCP‐gated plans compared to those with non‐PCP‐gated plans (OR: OAC 1.01, P = 0.84; warfarin 1.05, P = 0.08). Relative odds were similar for rate control (1.17, P < 0.01) and rhythm control agents (0.93, P = 0.03). However, PCP‐gated plan patients had slightly lower likelihood of being prescribed NOACs (0.82, P = 0.001) than non‐gated plan patients. Elapsed time until receipt of medication was similar between PCP‐gated and non‐gated groups across drug classes. CONCLUSIONS: Pharmaceutical claims data do not suggest that PCP‐gatekeeping by healthcare plans is a structural barrier to AF therapy, although it was associated with lower use of NOACs.

Background: Atrial fibrillation (AF) occurs in many clinical contexts and is diagnosed and treated by clinicians across many specialties. This approach has resulted in treatment variations....

Patients with atrial fibrillation (AF) treated with percutaneous coronary intervention (PCI) require multiple antithrombotic therapies. The optimal strategy is debated suggesting increased treatment variation. This study sought to characterize site-level variation in antithrombotic therapies in AF patients after PCI and determine the association with outcomes.Using the retrospective TREAT-AF study (The Retrospective Evaluation and Assessment of Therapies in AF) from the Veterans Health Administration, patients with newly diagnosed, nonvalvular AF between 2004 and 2015 followed by a PCI with a P2YOf 230 762 patients with newly diagnosed AF, 4042 (1.8%) underwent PCI and received a P2YIn patients with established AF undergoing PCI, the use of OAC+PI varied substantially across sites in the 30 days post-PCI. Anticoagulation appeared to be underutilized but was associated with improved outcomes. Strategies to promote OAC+PI and minimize site variation may be useful, particularly in light of recent randomized trials.

Background: Patients with atrial fibrillation (AF) treated with percutaneous coronary intervention (PCI) require multiple antithrombotic therapies. The optimal strategy is debated suggesting increased treatment variation. This study sought to characterize site-level variation in antithrombotic therapies in AF patients after PCI and determine the association with outcomes. Methods: Using the retrospective TREAT-AF study (The Retrospective Evaluation and Assessment of Therapies in AF) from the Veterans Health Administration, patients with newly diagnosed, nonvalvular AF between 2004 and 2015 followed by a PCI with a P2Y 12 -antagonist prescription were identified. Patients were grouped according to the therapy dispensed 7 days before until 30 days after the PCI: oral anticoagulation plus platelet inhibition (OAC+PI) or platelet inhibition only. A combined outcome of death, myocardial infarction, stroke, or major bleeding was assessed 1 year after PCI and Cox regression was performed to estimate hazard ratios. Results: Of 230 762 patients with newly diagnosed AF, 4042 (1.8%) underwent PCI and received a P2Y 12 -antagonist during the observation period (age, 67±9 years; CHA 2 DS 2 -VASc, 2.7±1.7; HAS-BLED, 2.6±1.2). Among these, 47% were prescribed OAC+PI, and 53% platelet inhibition only 7 days before until 30 days after the PCI. Across 63 sites, the use of OAC+PI ranged from 19% to 66%. Prescription of OAC+PI was independently associated with a reduction in the combined outcome of death, myocardial infarction, stroke, or major bleeding compared with platelet inhibition only (adjusted hazard ratio, 0.85; 95% CI, 0.73–0.99; P =0.033). Conclusions: In patients with established AF undergoing PCI, the use of OAC+PI varied substantially across sites in the 30 days post-PCI. Anticoagulation appeared to be underutilized but was associated with improved outcomes. Strategies to promote OAC+PI and minimize site variation may be useful, particularly in light of recent randomized trials.

Background Patient satisfaction with therapy is an important metric of care quality and has been associated with greater medication persistence. We evaluated the association of patient satisfaction with warfarin therapy to other metrics of anticoagulation care quality and clinical outcomes among patients with atrial fibrillation ( AF ). Methods and Results Using data from the ORBIT ‐ AF (Outcomes Registry for Better Informed Treatment of Atrial Fibrillation) registry, patients were identified with AF who were taking warfarin and had completed an Anti‐Clot Treatment Scale ( ACTS ) questionnaire, a validated metric of patient‐reported burden and benefit of oral anticoagulation. Multivariate regressions were used to determine association of ACTS burden and benefit scores with time in therapeutic international normalized ratio range ( TTR ; both ≥75% and ≥60%), warfarin discontinuation, and clinical outcomes (death, stroke, major bleed, and all‐cause hospitalization). Among 1514 patients with AF on warfarin therapy (75±10 years; 42% women; CHA 2 DS 2 ‐ VAS c 3.9±1.7), those most burdened with warfarin therapy were younger and more likely to be women, have paroxysmal AF , and to be treated with antiarrhythmic drugs. After adjustment for covariates, ACTS burden scores were independent of TTR ( TTR ≥75%: odds ratio, 1.01 [95% CI , 0.99–1.03]; TTR ≥60%: odds ratio, 1.01 [95% CI , 0.98–1.05]), warfarin discontinuation (odds ratio, 0.99; 95% CI , 0.97–1.01), or clinical outcomes. ACTS benefit scores were also not associated with TTR , warfarin discontinuation, or clinical outcomes. Conclusions In a large registry of patients with AF taking warfarin, ACTS scores provided independent information beyond other traditional metrics of oral anticoagulation care quality and identified patient groups at high risk for dissatisfaction with warfarin therapy.

Background: Device-detected atrial fibrillation (AF) is associated with increased risk of stroke; however, there are no clearly defined thresholds of AF burden at which to initiate oral anticoagulation (OAC). We sought to describe OAC prescription practice variation in response to new device-detected AF and the association with outcomes. Methods: We performed a retrospective cohort study using data from the Veterans Health Administration linked to remote monitoring data that included day-level AF burden. We included patients with cardiac implantable electronic devices and remote monitoring from 2011 to 2014, CHA 2 DS 2 -VASc score ≥2, and no prior stroke or OAC receipt in the preceding 2 years. We determined the proportion of patients prescribed OAC within 90 days after new device-detected AF across a range of AF thresholds (≥6 minutes to >24 hours) and examined site variation in OAC prescription. We used multivariable Cox proportional hazards regressions to determine the association of OAC prescription with stroke by device-detected AF burden. Results: Among 10 212 patients with cardiac implantable electronic devices, 4570 (45%), 3969 (39%), 3263 (32%), and 2469 (24%) had device-detected AF >6 minutes, >1 hour, >6 hours, and >24 hours, respectively. For device-detected AF >1 hour, 1712 patients met inclusion criteria (72±10 years; 1.5% female; CHA 2 DS 2 -VASc score 4.0±1.4; HAS-BLED score 2.6±1.1). The proportion receiving OAC varied based on device-detected AF burden (≥6 minutes: 272/2101 [13%]; >1 hour: 273/1712 [16%]; >6 hours: 263/1279 [21%]; >24 hours: 224/818 [27%]). Across 52 sites (N=1329 patients), there was substantial site-level variation in OAC prescription after device-detected AF >1 hour (median, 16%; range, 3%–67%; median odds ratio, 1.56 [95% credible interval, 1.49–1.71]). In adjusted models, OAC prescription after device-detected AF >24 hours was associated with reduced stroke risk (hazard ratio, 0.28; 95% CI, 0.10–0.81; P =0.02), although the propensity-adjusted model was significant when AF lasted at least 6 minutes. Conclusions: Among veterans with cardiac implantable electronic devices, device-detected AF is common. There is large practice variation in 90-day OAC initiation after new device-detected AF, with low rates of treatment overall, even for episodes that last >24 hours. The strongest association of OAC with reduction in stroke was observed after device-detected AF >24 hours. Randomized trials are needed to confirm these observational findings.

BACKGROUND Urinary tract infection (UTI) is common after surgical procedures and a quality improvement target. For non-surgical procedures such as catheter ablation of atrial fibrillation (AF), UTI risk has not been characterized. We sought to determine incidence and risk factors of UTI after AF ablation and risk variation across sites. METHODS Using Marketscan commercial claims databases, we performed a retrospective cohort study of patients who underwent AF ablation from 2007 to 2011. The primary outcome was UTI diagnosis within 30 days after ablation. We performed multivariate analyses to determine risk factors for UTI and risk of sepsis within 30 days after ablation with UTI as the predictor variable. Median odds ratio was used to quantify UTI site variation. RESULTS Among 21 091 patients (age 59.2 ± 10.9; 29.1% female; CHA2 DS2 -VASc 2.0 ± 1.6), 622 (2.9%) were diagnosed with UTI within 30 days. In multivariate analyses, UTI was independently associated with age, female sex, prior UTI, and general anesthesia (all P

Of contemporary warfarin treated atrial fibrillation (AF) patients eligible for direct oral anticoagulants (DOAC), many remain on warfarin. However, expected INR time in therapeutic range (TTR) of potential switchers has not been characterized. We performed a retrospective cohort study of patients

Background The objective was to explore the efficacy of ablation lesion sets in addition to pulmonary vein isolation ( PVI ) for paroxysmal atrial fibrillation. The optimal strategy for catheter ablation of paroxysmal atrial fibrillation is debated. Methods and Results The SMASH‐AF (Systematic Review and Meta‐analysis of Ablation Strategy Heterogeneity in Atrial Fibrillation) study cohort includes trials and observational studies identified in PubMed, Scopus, and Cochrane databases from January 1 1990, to August 1, 2016. We included studies reporting single procedure paroxysmal atrial fibrillation ablation success rates. Exclusion criteria included insufficient reporting of outcomes, ablation strategies that were not prespecified and uniform, and a sample size of fewer than 40 patients. We analyzed lesion sets performed in addition to PVI ( PVI plus) using multivariable random‐effects meta‐regression to control for patient, study, and procedure characteristics. The analysis included 145 total studies with 23 263 patients ( PVI‐ only cohort: 115 studies, 148 treatment arms, 16 500 patients; PVI plus cohort: 39 studies; 46 treatment arms, 6763 patients). PVI plus studies, as compared with PVI ‐only studies, included younger patients (56.7 years versus 58.8 years, P =0.001), fewer women (27.2% versus 32.0% women, P =0.002), and were more methodologically rigorous with longer follow‐up (29.5 versus 17.1 months, P 0.004) and more randomization (19.4% versus 11.8%, P PVI plus studies were associated with improved success (7.6% absolute improvement [95% CI, 2.6–12.5%]; P I 2 =88%), specifically superior vena cava isolation (4 studies, 4 treatment arms, 1392 patients; 15.1% absolute improvement [95% CI, 2.3–27.9%]; P 0.02, I 2 =87%). However, residual heterogeneity was large. Conclusions Across the paroxysmal atrial fibrillation ablation literature, PVI plus ablation strategies were associated with incremental improvements in success rate. However, large residual heterogeneity complicates evidence synthesis.

Background Approaches, tools, and technologies for atrial fibrillation (AF) ablation have evolved significantly since its inception. We sought to characterize secular trends in AF ablation success rates. Methods We performed a systematic review and meta-analysis of AF ablation from January 1, 1990, to August 1, 2016, searching PubMed, Scopus, and Cochrane databases. Major exclusion criteria were insufficient outcome reporting and ablation strategies that were not prespecified and uniform. We stratified treatment arms by AF type (paroxysmal AF; nonparoxysmal AF) and analyzed single-procedure outcomes. Multivariate meta-regressions analyzed effects of study, patient, and procedure characteristics on success rate trends. Registered in PROSPERO (CRD42016036549). Results A total of 180 trials and observational studies with 28,118 patients met inclusion. For paroxysmal AF ablation studies, unadjusted success rate summary estimates ranged from 73.1% in 2003 to 77.1% in 2016, increasing by 0.9%/year (95% CI 0.4%-1.4%; P = .001; I2 = 90%). After controlling for study design and patient demographics, rate of improvement in success rate summary estimate increased (1.6%/year; 95% CI 0.9%-2.2%; P = .001; I2 = 87%). For nonparoxysmal AF ablation studies, unadjusted success rate summary estimates ranged from 70.0% in 2010 to 64.3% in 2016 (1.1%/year; 95% CI −1.3% to 3.5%; P = .37; I2 = 85%), with no improvement in multivariate analyses. Conclusions Despite substantial research investment and health care expenditure, improvements in AF ablation success rates have been incremental. Meaningful improvements may require major paradigm or technology changes, and evaluation of clinical outcomes such as mortality and quality of life may prove to be important going forward.

BACKGROUND: Cost-effectiveness or value of cardiovascular therapies may be undermined by unwarranted cost variation, particularly for heterogeneous procedures such as catheter ablation for atrial fibrillation (AF). We sought to characterize cost variation of AF ablation in the US health-care system and the relationship between cost and outcomes. METHODS AND RESULTS: We performed a retrospective cohort study using data from the MarketScan(®) commercial claims and Medicare supplemental databases including patients who received an AF ablation from 2007 to 2011. We aggregated encounter cost, reflecting total payments received for the encounter, to the facility level to calculate median facility cost. We classified procedures as outpatient or inpatient and assessed for association between cost and 30-day and 1-year outcomes. The analysis cohort included 9,415 AF ablations (59±11 years; 28% female; 52% outpatient) occurring at 327 facilities, with large cost variation across facilities (median: $25,100; 25th percentile: $18,900, 75th percentile: $35,600, 95th percentile: $57,800). Among outpatient procedures, there was reduced healthcare utilization in higher cost quintiles with reductions in rehospitalization at 30-days (Quintile 1: 16.1%, Quintile 5: 8.8%, P < 0.001) and 1-year (Quintile 1: 34.8%, Quintile 5: 25.6%, P < 0.001), which remained significant in multivariate analysis. CONCLUSIONS: Although median costs of AF ablation are below amounts used in prior cost-effectiveness studies that demonstrated good value, large facility variation in cost suggests opportunities for cost reduction. However, for outpatient encounters, association of cost to modestly improved outcomes suggests cost containment strategies could have variable effects.

Background We sought to characterize the prognostic value of the third universal definition of myocardial infarction (UDMI) and ≥ 40 msec Q wave criteria. Methods We evaluated hazard ratios (HR) with 95% confidence intervals (CI) for cardiovascular (CV) death for computerized Q wave measurements from the electrocardiograms of 43,661 patients collected from 1987 to 1999 at the Palo Alto VA. There were 3929 (9.0%) CV deaths over a mean follow-up of 7.6 (± 3.8) years. Results The risk of CV death for Q waves ≥ 40 msec in any two contiguous leads in any lead group was equivalent to or higher than that for contiguous UDMI Q waves, with HR 2.44 (95% CI 2.15–4.11) and HR 2.42 (95% CI (2.18–3.42), respectively. Conclusions The UDMI Q wave criteria do not provide an advantage over ≥ 40 msec Q waves at predicting CV death.

Introduction We performed a systematic review and meta-analysis of geographic and racial representation and reported success rates of studies of catheter ablation for atrial fibrillation (AF). Methods and results We searched PubMed, Scopus, and Cochrane databases from 1/1/1990 to 8/1/2016 for trials and observational studies reporting AF ablation outcomes. Major exclusion criteria were insufficient reporting of outcomes, non-English language articles, and ablation strategies that were not prespecified and uniform. We described geographic and racial representation and single-procedure ablation success rates by country, controlling for patient demographics and study design characteristics. The analysis cohort included 306 studies (49,227 patients) from 28 countries. Over half of the paroxysmal (PAF) and nonparoxysmal AF (NPAF) treatment arms were conducted in 5 and 3 countries, respectively. Reporting of race or ethnicity demographics and outcomes were rare (1 study, 0.3%) and nonexistent, respectively. Unadjusted success rates by country ranged from 63.5% to 83.0% for PAF studies and 52.7% to 71.6% for NPAF studies, with substantial variation in patient demographics and study design. After controlling for covariates, South Korea and the United States had higher PAF ablation success rates, with large residual heterogeneity. NPAF ablation success rates were statistically similar by country. Conclusions Studies of AF ablation have substantial variation in patient demographics, study design, and reported outcomes by country. There is limited geographic representation of trials and observational studies of AF ablation and a paucity of race- or ethnicity-stratified results. Future AF ablation studies and registries should aim to have broad representation by race, geography, and ethnicity to ensure generalizability.

Atrial fibrillation (AF) occurs in many clinical contexts and is diagnosed and treated by clinicians across many specialties. This approach has resulted in treatment variations.The goal of this study was to evaluate the association between treating specialty and AF outcomes among patients newly diagnosed with AF.Using data from the TREAT-AF (Retrospective Evaluation and Assessment of Therapies in AF) study from the Veterans Health Administration, patients with newly diagnosed, nonvalvular AF between 2004 and 2012 were identified who had at least 1 outpatient encounter with primary care or cardiology within 90 days of the AF diagnosis. Cox proportional hazards regression was used to evaluate the association between treating specialty and AF outcomes.Among 184,161 patients with newly diagnosed AF (age 70 ± 11 years; 1.7% women; CHAIn patients with newly diagnosed AF, cardiology care was associated with improved outcomes, potentially mediated by early prescription of oral anticoagulation therapy. Although hypothesis-generating, these data warrant serious consideration and study of health care system interventions at the time of new AF diagnosis.

The third Universal Definition of Myocardial Infarction (UDMI) includes electrocardiographic criteria for ischemia, specifying horizontal or down-sloping ST depression ≥0.05 mV in two contiguous electrocardiogram (ECG) leads. We used the surrogate of cardiovascular (CV) death to evaluate the criteria.We collected computerized ST amplitude measurements, in different lead groupings, from the resting ECGs of 43,661 patients collected between 1987 and 1999 at the Palo Alto VA. There were 3929 (9.0%) cardiac deaths over a mean follow-up of 7.6 (SD 3.8) years.We found that horizontal or down-sloping ST depressions in contiguous leads, depending upon the lead groupings, had sensitivities ranging from 1% to 5%, specificities exceeding 99%, and relative risks for CV death ranging from 3.1 to 7.0 (p0.001 for each individual relative risk) while horizontal or down-sloping ST depressions in a single lead had comparable values. We found that up-sloping ST depressions had greater sensitivities than horizontal or down-sloping ST depressions. Additionally, we found that ST depressions isolated to the inferior or anterior leads, without concomitant lateral depressions, were poor predictors of CV death.These findings reinforce and further characterize the value of ST depressions for predicting CV death. Furthermore, if these findings can be reproduced in the acute setting, they would undermine the requirement for contiguous lead depressions with slope assessment as well as prioritize ST depression in V4, V5, and V6 when assessing for myocardial ischemia.

OBJECTIVES/SPECIFIC AIMS: Atrial fibrillation (AF) is the most commonly encountered arrhythmia in clinical practice, and has widely varying treatments for stroke prevention and rhythm management. Some of these therapies are increasingly being prescribed by primary care physicians (PCPs). We therefore sought to investigate if healthcare plans with PCP gatekeeping for access to specialists are associated with different pharmacologic treatment strategies for the disease. In particular, we focused on oral anticoagulants (OACs), non-vitamin K-dependent oral anticoagulants (NOACs), rate control, and rhythm control medications. METHODS/STUDY POPULATION: We examined a commercial pharmaceutical claims database (Truven Marketscan™) to compare the prescription frequency of OAC, rate control, and rhythm control medications used to treat AF between patients with PCP-gated health plans (where the PCP is the gatekeeper to specialist referral—i.e., HMO, EPO, POS) and patients with non-PCP-gatekeeper health plans (i.e., comprehensive, PPO, CHDP, HDHP). To control for potential confounders, we also used multivariable logistic regression models to calculate adjusted odds ratios which accounted for age, sex, region, Charlson comorbidity index, CHADS2Vasc score, hypertension, diabetes, stroke/transient ischemic attack, prior myocardial infarction, peripheral artery disease, and antiplatelet medication use. We also calculated median time to therapy to determine if there was a difference in time to new prescription of these medications. RESULTS/ANTICIPATED RESULTS: We found only small differences between patients in PCP-gated and non-PCP-gated plans regarding prescription proportion of anticoagulants at 90 days following new AF diagnosis (OAC 44.2% vs. 42%, ppp=0.64). We observed similar trends for rate control agents (76.4% vs. 73.4%, pp=0.83). We found similar odds of OAC prescription at 90 days following new AF diagnosis between patients in PCP-gated and non-PCP-gated plans (adjusted OR for PCP-gated plans relative to non-gated plans: OAC 1.006, p=0.84; warfarin 1.054, p=0.08; NOAC 0.815, p=0.001; dabigatran 0.833, p=0.004; and rivaroxaban 0.181, p=0.02). We observed similar trends for rate control agents (1.166, pp=0.03). Elapsed time until receipt of medication was similar between PCP-gated and non-gated groups [OAC 4±14 days (interquartile range) vs. 5±16 days, ppp=0.2937; rhythm control 13±35 vs. 13±34, p=0.8661; rate control 10±25 vs. 11±30, p

There are no clearly-defined thresholds of device-detected atrial fibrillation (DDAF) burden for which to initiate oral anticoagulation (OAC). We performed a retrospective cohort study using data from the national Veterans Health Administration health care system linked to remote monitoring (RM)

The CHA2DS2-VASc score, validated in older and morbid cohorts, guides treatment decisions in patients with atrial fibrillation (AF). We previously found a claims-based frailty phenotype was associated with the CHA2DS2-VASc score and theorize that frailty may be an important driver of outcomes across

Objectives We sought to investigate the radiation exposure and contrast utilization associated with using a strategy of transradial access and rotational angiography (radial-DARCA) compared to the traditional approach of transfemoral access and standard angiography (femoral-SA). Background There is an increased focus on optimizing patient safety during cardiac catheterization procedures. Professional guidelines have highlighted physician responsibility to minimize radiation doses and contrast volume. Dual axis rotational coronary angiography (DARCA) is the most recently investigated type of rotational angiography. This new technique permits complete visualization of the left or right coronary tree with a single injection, and is felt to reduce contrast and radiation exposure. Methods A total of 56 consecutive patients who underwent radial-DARCA were identified. From the same time period, an age- and gender-matched group of 61 patients who had femoral-SA were selected for comparison. Total volume of contrast agent used, fluoroscopy time, and 2 measures of radiation dose (dose area product and air kerma) were recorded for each group. Results Mean contrast agent use and patient radiation exposure of the radial-DARCA group were significantly less than that of the femoral-SA group. There was no significant difference in fluoroscopy time between the 2 groups. Conclusions Physicians can successfully employ an innovative safety strategy of transradial access combined with DARCA that is feasible and is associated with lower radiation doses and contrast volume than femoral artery access and traditional coronary angiography approach. (J Interven Cardiol 2013;26:524-529)

As pointed out by Dr. Hussain and colleagues, understanding mediators of the association of cardiology care to improved outcomes for patients with atrial fibrillation is a critical knowledge gap highlighted by our recent work [(1)][1]. We agree that care unrelated to anticoagulation likely