Alan P. Wimmer

Development and Validation of the Atrial Fibrillation Effect on QualiTy-of-Life (AFEQT) Questionnaire in Patients With Atrial Fibrillation

Background—Atrial fibrillation (AF) has a deleterious impact on health-related quality-of-life (HRQoL), but measuring this outcome is difficult. A comprehensive, validated, disease-specific questionnaire to measure the spectrum of QoL domains affected by AF and its treatment is not available. We developed and validated a 20-item questionnaire, Atrial Fibrillation Effect on QualiTy-of-life (AFEQT), in a 6-center, prospective, observational study. Methods and Results—Factor analyses established 4 conceptual domains (Symptoms, Daily Activities, Treatment Concern, and Treatment Satisfaction) from which individual domain and global scores were calculated. Participants from 6 centers completed the AFEQT at baseline, at month 1, and at month 3. Psychometric analyses included internal consistency and known-group validity. Test-retest reliability was assessed by comparing 1-month changes in scores among those with no change in therapy. Effect size was used to assess responsiveness after intervention. Among 219 patients age 62±11.9 years, 94% completed the AFEQT at baseline and 3 months; 66% had paroxysmal, 24% persistent, 5% longstanding persistent, and 5% permanent AF. Internal consistency was >0.88 for all scales. Lower AFEQT scores were observed with increased AF severity, categorized as asymptomatic, mild, moderate and severe, respectively: 71.2±20.6, 71.3±19.2, 57.9±19.0, and 42.0±21.2. Intraclass correlations for Overall, Symptoms, Daily Activities, Treatment Concern, and Satisfaction scores were 0.8, 0.5, 0.8, 0.7, and 0.7, respectively. Changes in 3-month scores were larger after ablation than with pharmacological adjustments, and both were greater than those observed in stable patients. Conclusions—This initial validation of AFEQT supports its use as an outcome in studies and a means to clinically follow patients with AF.

Safety and efficacy of interrupted dabigatran for peri-procedural anticoagulation in catheter ablation of atrial fibrillation: a systematic review and meta-analysis

AIMS To examine the safety (defined as bleeding risk) and efficacy (defined as prevention of thromboembolic events) of interrupted dabigatran for peri-procedural anticoagulation in catheter ablation (CA) of atrial fibrillation (AF) in comparison with warfarin. METHODS AND RESULTS Reviewers independently searched literature databases from January 2010 through April 2013 for studies comparing the safety and efficacy of dabigatran and warfarin in CA of AF and extracted pre-defined data. The Mantel-Haenszel method was used to pool data of bleeding and thromboembolism outcomes into random and fixed effect model meta-analyses, respectively. Odds ratios (ORs), and risk difference (RD) analysis when studies reported no events in either arm, were used to generate an overall effect estimate of both outcomes. Publication bias and heterogeneity were assessed by contour funnel plot and the I(2) test, respectively. Nine citations, including 3036 patients (1073 dabigatran), met the inclusion criteria. There was no significant difference between interrupted dabigatran and warfarin therapy in CA of AF in occurrence of bleeding [dabigatran 58 (5.4%), warfarin 103 (5.2%); OR 0.92 (95% confidence interval (CI) 0.55-1.45); χ(2) = 13.03-P = 0.11; I(2) = 39%] or thromboembolism [dabigatran 5 (0.4%), warfarin 2 (0.1%); OR 2.15 (95% CI-0.58-7.98); χ(2) = 2.14, P = 0.54; I(2) = 0%; RD 0.00 (95% CI-0.00 to 0.01); χ(2) = 3.37, P = 0.81; I(2) = 0%]. Analysis of pre-defined subgroups (published articles vs. abstracts), sensitivity analyses (interrupted warfarin, USA studies, and Japanese studies) and fixed effect model analyses showed similar results. Heterogeneity was mild in the bleeding outcome analysis and zero in thromboembolism. There was no evidence of publication bias in either meta-analysis. CONCLUSION Meta-analysis of currently available studies showed no significant difference in bleeding and thromboembolism between interrupted dabigatran and warfarin therapy in CA of AF. Dabigatran appears to be safe and effective for peri-procedural anticoagulation in CA of AF.

Resolution (and Late Recurrence) of WATCHMAN Device-Related Thrombus Following Treatment with Dabigatran.

The WATCHMAN left atrial (LA) appendage closure system is an alternative therapy for stroke prevention in patients with atrial fibrillation who are intolerant to chronic oral anticoagulation with warfarin. Infrequently, LA device–related thrombus (DRT) has been suspected. Optimal treatment of DRT is not known, and the efficacy of novel oral anticoagulants (NOAC) in this setting has not been previously described. A 69‐year‐old woman with permanent atrial fibrillation underwent WATCHMAN device placement. A transesophageal echocardiogram (TEE) performed 45 days following implant revealed a well‐seated device. A 1‐year follow‐up TEE revealed a 1.2 × 0.8 cm sized DRT on the LA aspect of the WATCHMAN device. She was prescribed dabigatran 150 mg po BID for 3 months and she remained on aspirin 325 mg per day. She returned approximately 4 months later (and several weeks after completing her 3‐month course of dabigatran) for a repeat TEE, which revealed complete resolution of the DRT. A TEE was performed approximately 8 months later and revealed a new DRT measuring 1 cm in diameter on the LA aspect of the device. This is the first report of successful WATCHMAN DRT treatment with a NOAC, and the first report of late DRT recurrence following treatment to resolution with an anticoagulant. This case report demonstrates that (1) WATCHMAN DRT may form late following implantation, (2) DRT resolution is possible with NOACs, specifically dabigatran, and (3) late recurrence of DRT is possible, even after treatment to initial resolution with systemic anticoagulation.

Dabigatran in the setting of catheter ablation of atrial fibrillation: the road ahead

To the Editor We read with interest the study by Providencia et al 1 which demonstrated that dabigatran had a similar efficacy and safety profile as warfarin in the setting of catheter ablation (CA) of atrial fibrillation (AF). These findings concur with two other meta-analyses on the same topic (including one from our group), which have been …

Successful ablation of macroreentrant left atrial tachycardia after pulmonary vein isolation in a patient with cor triatriatum

Figure 1 A 69-year-old man with newly discovered nonobstructive cor triatriatum was scheduled for catheter ablation for drugrefractory persistent atypical atrial flutter. Two years previously he had undergone an electrophysiological study for recurrent atrial tachycardia. Four different left atrial (LA) focal tachycardias were observed. Two of the tachycardias were stable enough to be mapped and ablated (one at the base of the LA appendage and the other at the mid-LA septum). Pulmonary vein origin was suspected for the remaining tachycardias, and empiric circumferential antral pulmonary vein isolation (PVI) was performed. Transesophageal echocardiography (TEE) or computed tomography (CT) cardiac imaging was not obtained at that time. A dual-chamber pacemaker was implanted after the procedure for preablation sick sinus syndrome. Pacemaker interrogation revealed no significant arrhythmias during 2 years of follow-up until the recent development of a persistent, regular atrial tachycardia with a cycle length of 280 ms and both 1:1 and 2:1 atrioventricular conduction. In preparation for the procedure, a cardiac-gated CT scan and TEE were performed, both revealing an intra-atrial membrane separating the LA into 2 chambers. The pulmonary veins were visualized draining into 1 chamber. The other chamber contained the LA appendage and the mitral valve orifice consistent with cor triatriatum as shown in the transverse CT image (Figure 1). TEE showed no significant intra-atrial hemodynamic obstruction by the membrane. There was no other evidence of congenital heart disease. During the catheter ablation procedure, navigation through the fenestration connecting the 2 atrial chambers was achieved by withdrawing the ablation catheter back near the septum. A multielectrode ring catheter demonstrated

Hemodynamically Significant Iatrogenic Atrial Septal Defects after Cryoballoon Ablation

Left atrial procedures requiring large sheaths and manipulation within the left atrium are increasingly common in electrophysiology. Iatrogenic atrial septal defects (iASD) created for these procedures are generally benign and do not require closure. In this report we describe 2 hemodynamically significant atrial septal defects (ASD) that occurred after cryoballoon ablation for pulmonary vein isolation.

The “absent” left atrial appendage…

Introduction Isolated congenital absence of the left atrial appendage (LAA) is a rare condition. The diagnosis results from a review of the past medical and surgical history in addition to the use of multimodality imaging, as several other conditions (thrombotic occlusion, surgical or percutaneous exclusion, variations in morphology and relative position of anatomic structures) may present with a similar finding.

Azithromycin for Elderly Patients With Pneumonia

In Reply We agree with Dr Beresford that patient-centered care with shared decision making is not a new concept in medicine. However, patient-centered care is not currently the routine approach to management of alcohol use disorders in medical settings. Instead, referral to specialty treatment is often recommended for patients diagnosed with alcohol use disorders.1 Therefore, we outlined treatments for alcohol use disorders, supported by randomized clinical trials, that have been recommended in evidence-based clinical practice guidelines developed by the UK National Institute of Clinical Effectiveness, as well as those developed by the US Department of Veterans Affairs and the Department of Defense.2,3 Currently, only about 8% of US adults with alcohol use disorders receive treatment.4 Offering patients different treatment options could increase the proportion of patients engaged in treatment.