Left Atrial Appendage Ligation Using the AtriClip Device: Single-Center Study of Device Safety and Efficacy.

Objective: Left atrial appendage (LAA) occlusion at the time of cardiac surgery in patients with atrial fibrillation has been shown to reduce the incidence of postoperative embolic stroke. However, the optimal method for LAA occlusion is not universally accepted. We sought to examine the safety and effectiveness of LAA occlusion with the AtriClip epicardial occlusion device. Methods: Cardiac surgical patients with atrial fibrillation who underwent LAA AtriClip placement were evaluated prospectively. Clip placement and clinical outcomes were examined after 1 year of follow-up with transesophageal echocardiography (TEE). The presence of a 10 mm or greater residual pouch, presence of flow into the LAA, or device-related thrombus (DRT) were considered failures. Results: Ninety-seven patients were analyzed. The mean CHA2DS2-VASc score was 2.4 ± 1.4. The postoperative follow-up period ranged from 366 to 1,693 days (mean 685 days or 1.87 years). Seventy-four AtriClips were placed with video-assisted thoracic surgery, whereas 23 were placed via sternotomy or thoracotomy. Successful closure was found in 96% (93 of 97) of patients at follow-up. Failure occurred in 4 patients. No clip migration or DRT was seen on 3-dimensional imaging. Of all 97 patients, 76 (78%) were on presurgical oral anticoagulation, whereas 5 (5.1%) were on postprocedure oral anticoagulation. There were no postoperative thromboembolic events at the time of the study TEE. Conclusions: The AtriClip epicardial surgical occlusion device can provide an excellent rate of successful closure of the LAA during surgical ablation procedures without DRT.

A heart-team hybrid approach for atrial fibrillation: a single-centre long-term clinical outcome cohort study.

OBJECTIVES: The Cox-maze IV is the gold standard for surgical ablation of atrial fibrillation (AF). A heart-team hybrid approach using selected epicardial thoracoscopic surgical ablations and completion endocardial ablations to replicate the Cox-maze IV lesion set has gained popularity and early results have been promising. We herein report our single-centre long-term clinical outcomes using the heart-team hybrid approach with 455 patients. METHODS: From 1 March 2013 to 1 July 2019, we prospectively collected data on all patients referred to our heart team for rhythm-control strategy for AF. Baseline characteristics, procedural complications and long-term freedom from AF (FFAF) both on and off anti-arrhythmic drug therapy were analysed. Ambulatory monitoring (>7 days) was obtained at 3 months and annually thereafter. RESULTS: Four hundred and fifty-five patients completed the hybrid approach. Four hundred and forty-five (97.8%) patients had non-paroxysmal AF (long-standing persistent AF n = 249, 54.7%; persistent AF n = 196, 43.1%; paroxysmal AF n = 10, 2.2%). Average duration of AF was 5.9 ± 6.1 years. Average left atrial diameter was 4.8 ± 0.8 cm. FFAF at 3, 12, 24 and 36 months was 92%, 87%, 81% and 72%, respectively. FFAF without the use of anti-arrhythmic medications was 75%, 81%, 76% and 66%. Any surgical complications occurred in 28 (6.1%) patients. CONCLUSIONS: A heart-team hybrid strategy for the treatment of AF is safe and effective. In a predominantly non-paroxysmal population with AF, at the 3-year follow-up, FFAF in patients on and off anti-arrhythmic drugs approaches that of patients who had the Cox-maze IV.

First-in-Human Experience of Mechanical Preload Control in Patients With HFpEF During Exercise.

Exercise intolerance remains one of the major factors determining quality of life in heart failure patients. In 6 patients with heart failure with preserved ejection fraction (HFpEF) undergoing invasive cardiopulmonary exercise testing, balloon inflation within the inferior vena cava (IVC) was performed during exercise to reduce and maintain pulmonary arterial (PA) pressures. Partial IVC occlusion significantly reduced PA pressures without reducing cardiac output. Partial IVC occlusion significantly reduced respiratory rate at matched levels of exercise. These findings highlight the importance of pulmonary pressures in the pathophysiology of HFpEF and suggest that therapies targeting hemodynamics may improve symptoms and exercise capacity in these patients.

Incidence and outcomes of patients with atrial fibrillation and major bleeding complications: from the TREAT-AF study.

PURPOSE: 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. METHODS: 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. RESULTS: 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 < 0.0001) but no difference in intracranial bleeding. There was a trend toward decreased stroke risk (HR 0.85; 95% CI 0.71-1.02; p 0.09). CONCLUSIONS: Development 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.

Comparison of Patient-Reported Care Satisfaction, Quality of Warfarin Therapy, and Outcomes of Atrial Fibrillation: Findings From the ORBIT - AF Registry.

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.

A novel pacing maneuver to verify the postpacing interval minus the tachycardia cycle length while adjusting for decremental conduction: Using "dual-chamber entrainment" for improved supraventricular tachycardia discrimination.

BACKGROUND: The postpacing interval (PPI) minus the tachycardia cycle length (TCL) is frequently used to investigate tachycardias. However, a variety of issues (eg, failure to entrain, decremental conduction, and oscillating TCLs) can make interpretation of the PPI-TCL challenging. OBJECTIVE: The purpose of this study was to investigate a novel maneuver to confirm the PPI-TCL value without using either the ventricular PPI or the TCL interval and to assess the ability of this maneuver to identify decremental conduction and differentiate supraventricular tachycardias. METHODS: We analyzed 77 intracardiac recordings from patients (age 25 ± 20 years; 40 female) who underwent catheter ablation of atrioventricular nodal reentrant tachycardia (AVNRT) or orthodromic reciprocating tachycardia (ORT) with a concealed pathway. We calculated the PPI-TCL, the AH-corrected PPI-TCL, and estimated the PPI-TCL using "dual-chamber entrainment" calculated as [PPIV - TCL = Stim(A→V) + Stim(V→A) - PPIA]. RESULTS: The PPI-TCL calculated by dual-chamber entrainment highly correlated with the observed and AH-corrected PPI-TCL (R2 = 0.79 and 0.96, respectively; P <.001]. A dual-chamber entrainment PPI-TCL value of 80 ms correctly differentiated all AVNRT from septal ORT cases, whereas the standard PPI-TCL and AH-corrected PPI-TCL methods were incorrect in 14% and 6% of cases, respectively. Dual-chamber entrainment identified 3 ± 10 ms of additional decremental conduction beyond AH prolongation, including 4 pathways with significant (>10 ms) decrement. CONCLUSION: Dual-chamber entrainment estimates the PPI-TCL value without using either the ventricular PPI or the TCL interval. This maneuver adjusts for all decremental conduction, including within concealed pathways, where a dual-chamber entrainment PPI-TCL value >80 ms favors AVNRT over ORT. This maneuver can be used to verify the observed PPI-TCL value in challenging cases.

Patient and facility variation in costs of catheter ablation for atrial fibrillation.

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 healthcare 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.

Treating Specialty and Outcomes in Newly Diagnosed Atrial Fibrillation: From the TREAT-AF Study.

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. OBJECTIVES: The goal of this study was to evaluate the association between treating specialty and AF outcomes among patients newly diagnosed with AF. METHODS: 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. RESULTS: Among 184,161 patients with newly diagnosed AF (age 70 ± 11 years; 1.7% women; CHA2DS2-VASc score 2.6 ± 1.7), 40% received cardiology care and 60% received primary care only. After adjustment for covariates, cardiology care was associated with reductions in stroke (hazard ratio [HR]: 0.91; 95% confidence interval [CI]: 0.86 to 0.96; p < 0.001) and death (HR: 0.89; 95% CI: 0.88 to 0.91; p < 0.0001) and increases in hospitalizations for AF/supraventricular tachycardia (HR: 1.38; 95% CI: 1.35 to 1.42; p < 0.0001) and myocardial infarction (HR: 1.03; 95% CI: 1.00 to 1.05; p < 0.04). The propensity-matched cohort had similar results. In mediation analysis, oral anticoagulation prescription within 90 days of diagnosis may have mediated reductions in stroke but did not mediate reductions in survival. CONCLUSIONS: In 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.

Safety and Clinical Outcomes of Catheter Ablation of Atrial Fibrillation in Patients With Chronic Kidney Disease.

INTRODUCTION: Data regarding catheter ablation of atrial fibrillation (AF) in patients with chronic kidney disease (CKD) is limited. We therefore assessed the association of CKD with common safety and clinical outcomes in a nationwide sample of ablation recipients. METHODS: Using MarketScan® Commercial Claims and Medicare Supplemental Databases, we evaluated 30-day safety and 1-year clinical outcomes in patients who underwent a first AF ablation procedure between 2007 and 2011. We calculated frequency of common 30-day complications and calculated frequencies, incidence rates, and Cox proportional hazards for outcomes at 1-year postablation. RESULTS: Of 21,091 patients included, 1,593 (7.6%) had CKD. Patients with CKD were older (64 years vs. 59 years, P < 0.001) with higher CHA2 DS2 -VASc scores (3.2 vs. 1.8, P < 0.001). At 30 days postablation, patients with CKD had similar rates of stroke/TIA (0.13% vs. 0.13%, P = 0.99), perforation/tamponade (3.2% vs. 3.1%, P = 0.83), and vascular complications (2.4% vs. 2.2%, P = 0.59) as patients without CKD, but were more likely to be hospitalized for heart failure (2.1% vs. 0.4%, P < 0.001). In multivariate analysis, there were no significant differences in hazards of AF hospitalization (adjusted HR: 1.02, 95%CI: 0.87-1.20), cardioversion (adjusted HR: 0.99, 95%CI: 0.87-1.12), or repeat AF ablation (adjusted HR: 0.89, 95%CI: 0.76-1.06) at 1 year. CONCLUSIONS: Among patients selected for AF ablation, those with and without CKD had similar rates of postprocedural complications although they were more likely to be re-admitted for heart failure. CKD was not independently associated with AF hospitalization, cardioversion, and repeat ablation. These findings can inform clinical decision-making in patients with AF and CKD.

Warfarin utilisation and anticoagulation control in patients with atrial fibrillation and chronic kidney disease.

OBJECTIVE: To evaluate warfarin prescription, quality of international normalised ratio (INR) monitoring and of INR control in patients with atrial fibrillation (AF) and chronic kidney disease (CKD). METHODS: We performed a retrospective cohort study of patients with newly diagnosed AF in the Veterans Administration (VA) healthcare system. We evaluated anticoagulation prescription, INR monitoring intensity and time in and outside INR therapeutic range (TTR) stratified by CKD. RESULTS: Of 123 188 patients with newly diagnosed AF, use of warfarin decreased with increasing severity of CKD (57.2%-46.4%), although it was higher among patients on dialysis (62.3%). Although INR monitoring intensity was similar across CKD strata, the proportion with TTR≥60% decreased with CKD severity, with only 21% of patients on dialysis achieving TTR≥60%. After multivariate adjustment, the magnitude of TTR reduction increased with CKD severity. Patients on dialysis had the highest time markedly out of range with INR <1.5 or >3.5 (30%); 12% of INR time was >3.5, and low TTR persisted for up to 3 years. CONCLUSIONS: There is a wide variation in anticoagulation prescription based on CKD severity. Patients with moderate-to-severe CKD, including dialysis, have substantially reduced TTR, despite comparable INR monitoring intensity. These findings have implications for more intensive warfarin management strategies in CKD or alternative therapies such as direct oral anticoagulants.

Transforming the care of atrial fibrillation with mobile health.

Atrial fibrillation (AF) is a multifaceted and highly variable disease that is often difficult to manage within the traditional health-care model. The conventional model of regular or pre-scheduled appointments with physicians or allied health professionals is poorly suited to the unpredictable and often urgent clinical needs of patients with AF. Mobile health (mHealth) has the potential to dramatically transform the delivery and quality of AF care. In this brief review, we summarize the current limitations and evidence gaps in treating patients with AF. We then describe the current mHealth landscape, changes in telehealth coverage and reimbursement, and recent technological advances of smartphones, mobile applications, and connected wearable devices. We also describe important barriers and challenges, such as clinical management of large volumes of data, application of predictive analytics/machine learning, and the need for high-quality randomized clinical trials.

Cost-Effectiveness of Implantable Pulmonary Artery Pressure Monitoring in Chronic Heart Failure.

OBJECTIVES: This study aimed to evaluate the cost-effectiveness of the CardioMEMS (CardioMEMS Heart Failure System, St Jude Medical Inc, Atlanta, Georgia) device in patients with chronic heart failure. BACKGROUND: The CardioMEMS device, an implantable pulmonary artery pressure monitor, was shown to reduce hospitalizations for heart failure and improve quality of life in the CHAMPION (CardioMEMS Heart Sensor Allows Monitoring of Pressure to Improve Outcomes in NYHA Class III Heart Failure Patients) trial. METHODS: We developed a Markov model to determine the hospitalization, survival, quality of life, cost, and incremental cost-effectiveness ratio of CardioMEMS implantation compared with usual care among a CHAMPION trial cohort of patients with heart failure. We obtained event rates and utilities from published trial data; we used costs from literature estimates and Medicare reimbursement data. We performed subgroup analyses of preserved and reduced ejection fraction and an exploratory analysis in a lower-risk cohort on the basis of the CHARM (Candesartan in Heart failure: Reduction in Mortality and Morbidity) trials. RESULTS: CardioMEMS reduced lifetime hospitalizations (2.18 vs. 3.12), increased quality-adjusted life-years (QALYs) (2.74 vs. 2.46), and increased costs ($176,648 vs. $156,569), thus yielding a cost of $71,462 per QALY gained and $48,054 per life-year gained. The cost per QALY gained was $82,301 in patients with reduced ejection fraction and $47,768 in those with preserved ejection fraction. In the lower-risk CHARM cohort, the device would need to reduce hospitalizations for heart failure by 41% to cost <$100,000 per QALY gained. The cost-effectiveness was most sensitive to the device's durability. CONCLUSIONS: In populations similar to that of the CHAMPION trial, the CardioMEMS device is cost-effective if the trial effectiveness is sustained over long periods. Post-marketing surveillance data on durability will further clarify its value.

The precise timing of tachycardia entrainment is determined by the postpacing interval, the tachycardia cycle length, and the pacing rate: Theoretical insights and practical applications.

BACKGROUND: Previous observations have reported that the number of pacing stimuli required to entrain a tachycardia varies on the basis of arrhythmia type and location, but a quantitative formulation of the number needed to entrain (NNE) that unifies these observations has not been characterized. OBJECTIVE: We sought to investigate the relationship between the number of pacing stimulations, the tachycardia cycle length (TCL), the overdrive pacing cycle length (PCL), and the postpacing interval (PPI) to accurately estimate the timing of tachycardia entrainment. METHODS: First, we detailed a mathematical derivation unifying electrophysiological parameters with empirical confirmation in 2 patients undergoing catheter ablation of typical atrial flutter. Second, we validated our formula in 44 patients who underwent various catheter ablation procedures. For accuracy, we corrected for rate-related changes in conduction velocity. RESULTS: We derived the equations NNE = |(PPI - TCL)/(TCL - PCL)| + 1 and Tachycardia advancement = (NNE - 1) × (TCL - PCL) - (PPI - TCL), which state that the NNE and the amount of tachycardia advancement on the first resetting stimulation are determined using regularly measured intracardiac parameters. In the retrospective cohort, the observed PPI - TCL highly correlated with the predicted PPI - TCL (mean difference 5.8 ms; r = 0.97; P < .001), calculated as PPI - TCL = (NNE - 1) × (TCL - PCL) - tachycardia advancement. CONCLUSION: The number of pacing stimulations required to entrain a reentrant tachycardia is predictable at any PCL after correcting for cycle length-dependent changes in conduction velocity. This relationship unifies established empirically derived diagnostic and mapping criteria for supraventricular tachycardia and ventricular tachycardia. This relationship may help elucidate when antitachycardia pacing episodes are ineffective or proarrhythmic and could potentially serve as a theoretical basis to customize antitachycardia pacing settings for improved safety and effectiveness.

Gender Differences in Clinical Outcomes after Catheter Ablation of Atrial Fibrillation.

Objective: To explore gender differences in real-world outcomes after catheter ablation of atrial fibrillation (AF). Background: Compared to men, women with AF have greater thromboembolic risk and tend to be more symptomatic. Catheter ablation is generally more effective than antiarrhythmic drug therapy alone. However, there is limited data on the influence of gender on AF ablation outcomes. Methods: We analyzed medical claims of 45 million United States patients enrolled in a variety of employee-sponsored and fee-for-service plans. We identified patients who underwent an AF ablation from 2007 to 2011 and evaluated 30-day safety and one-year effectiveness outcomes. Results: Of the 21,091 patients who underwent an AF ablation, 7,460 (29%) were female. Women, compared to men, were older (62±11 vs. 58±11 years), had higher CHADS2 (1.2±1.1 vs. 1.0±1.0), higher CHA2DS2-VASc (2.9±1.5 vs. 1.6±1.4), and higher Charlson comorbidity index scores (1.2±1.3 vs. 1.0±1.2)(p<0.001 for all). Following ablation, women had higher risk of 30-day complications of hemorrhage (2.7 vs. 2.0%,p<0.001) and tamponade (3.8 vs. 2.9%,p<0.001). In multivariable analyses, women were more likely to have a re-hospitalization for AF (adjusted HR 1.12,p=0.009), but less likely to have repeat AF ablation (adjusted HR 0.92,p=0.04) or cardioversion (adjusted HR 0.75,p<0.001). Conclusion: Women have increased hospitalization rates after AF ablation and are more likely to have a procedural complication. Despite the higher rate of hospital admissions for AF after ablation, women were less likely to undergo repeat ablation or cardioversion. These data call for greater examination of barriers and facilitators to sustain rhythm control strategies in women.

Amiodarone and risk of death in contemporary patients with atrial fibrillation: Findings from The Retrospective Evaluation and Assessment of Therapies in AF study.

BACKGROUND: There are limited data on mortality outcomes associated with use of amiodarone in atrial fibrillation and flutter (AF). METHODS: We evaluated the association of amiodarone use with mortality in patients with newly diagnosed AF using complete data from the Department of Veterans Affairs national health care system. We included patients seen in an outpatient setting within 90 days of a new diagnosis for nonvalvular AF between Veterans Affairs fiscal years 2004 and 2008. Multivariate analysis and propensity-matched Cox proportional hazards regression were used to evaluate the association of amiodarone use to death. RESULTS: Of 122,465 patients (353,168 person-years of follow-up, age 72.1 ± 10.3 years, 98.4% males), amiodarone was prescribed in 11,655 (9.5%). Cumulative, unadjusted mortality rates were higher for amiodarone recipients than for nonrecipients (87 vs 73 per 1,000 person-years, P < .001). However, in multivariate and propensity-matched survival analyses, there was no significant difference in mortality (multivariate hazard ratio 1.01, 95% CI 0.97-1.05, P = .51, and propensity-matched hazard ratio 1.02, 95% CI 0.97-1.07, P = .45). The hazard of death was not modified by age, sex, heart failure, kidney function, ß-blocker use, or warfarin use, but there was evidence of effect modification among patients diagnosed with AF as an inpatient versus outpatient. CONCLUSION: In a national health care system population of newly diagnosed AF, overall use of amiodarone as an early treatment strategy was not associated with mortality.

Defibrillator implantations for primary prevention in the United States: Inappropriate care or inadequate documentation: Insights from the National Cardiovascular Data ICD Registry.

BACKGROUND: Prior studies have reported that more than 20% of implantable cardioverter-defibrillator (ICD) implantations in the United States do not adhere to trial-based criteria. OBJECTIVE: We sought to investigate the patient characteristics associated with not meeting the inclusion criteria of the clinical trials that have demonstrated the efficacy of primary prevention ICDs. METHODS: Using data from the National Cardiovascular Data Registry's ICD Registry, we identified patients who received ICDs for primary prevention from January 2006 to December 2008. We determined whether patients met the inclusion criteria of at least 1 of the 4 ICD primary prevention trials: Multicenter Automatic Defibrillator Implantation Trial (MADIT), MADIT-II, Sudden Cardiac Death in Heart Failure Trial (SCD-HeFT), and the Multicenter Unsustained Tachycardia Trial (MUSTT). RESULTS: Among 150,264 patients, 86% met criteria for an ICD implantation based on trial data. The proportion of patients who did not meet trial-based criteria increased as age decreased. In multivariate analysis, the significant predictors for not meeting trial criteria included prior cardiac transplantation (odds ratio [OR] 2.1), pediatric electrophysiology operator (OR 2.0), and high-grade atrioventricular conduction disease (OR 1.4). CONCLUSION: Among National Cardiovascular Data Registry registrants receiving first-time ICDs for primary prevention, the majority met trial-based criteria. Multivariate analyses suggested that many patients who did not meet the trial-based criteria may have had clinical circumstances that warranted ICD implantation. These findings caution against the use of trial-based indications to determine site quality metrics that could penalize sites that care for younger patients. The planned incorporation of appropriate use criteria into the ICD registry may better characterize patient- and site-level quality and performance.

The clinical efficacy of dabigatran etexilate for preventing stroke in atrial fibrillation patients.

The use of novel oral anticoagulants (NOACs) for stroke and systemic embolism prevention in the setting of specifically non valvular atrial fibrillation has provided clinicians with a realistic treatment alternative to the traditional dose-adjusted, warfarin-based anticoagulation that is targeted to a therapeutic international normalized ratio range of 2.0-3.0. We discuss the use of dabigatran in the setting of mechanical heart valves, atrial fibrillation or left atrial catheter ablation procedures, reversal of the drug in the setting of adverse bleeding events, and background on the molecular biology and development of this novel treatment for stroke reduction.

Continuous warfarin versus periprocedural dabigatran to reduce stroke and systemic embolism in patients undergoing catheter ablation for atrial fibrillation or left atrial flutter.

PURPOSE: Left atrial catheter ablation for patients with atrial fibrillation (AF) requires periprocedural anticoagulation to minimize thromboembolic complications. High rates of major bleeding complications using dabigatran etexilate for periprocedural anticoagulation have been reported, raising concerns regarding its safety during left atrial catheter ablation. We sought to evaluate the safety and efficacy of a dabigatran use strategy versus warfarin, at a single high-volume AF ablation center. METHODS: We performed a retrospective analysis on consecutive patients undergoing left atrial ablation at Vanderbilt Medical Center from January 2011 through August 2012 with a minimum follow-up of 3 months. Patient cohorts were divided into two groups, those utilizing dabigatran etexilate pre- and post-ablation and those undergoing ablation on dose-adjusted warfarin, with or without low-molecular-weight heparin bridging. Dabigatran was held 24-30 h pre-procedure and restarted 4-6 h after hemostasis was achieved. We evaluated all thromboembolic and bleeding complications at 3 months post-ablation. RESULTS: A total of 254 patients underwent left atrial catheter ablation for atrial fibrillation or left atrial flutter. Periprocedural anticoagulation utilized dabigatran in 122 patients and warfarin in 135 patients. Three late thromboembolic complications occurred in the dabigatran group (2.5 %), compared with one (0.7 %) in the warfarin group (p = 0.28). The dabigatran group had similar minor bleeding (2.5 vs. 7.4 %, p = 0.07), major bleeding (1.6 vs. 0.7 %, p = 0.51), and composite of bleeding and thromboembolic complications (6.6 vs. 8.9 %, p = 0.49) when compared to warfarin. There were no acute thromboembolic complications in either group (<24 h post-ablation). CONCLUSIONS: In patients undergoing left atrial catheter ablation for AF or left atrial flutter, use of periprocedural dabigatran etexilate provides a safe and effective anticoagulation strategy compared to warfarin. A prospective randomized study is warranted.