Real-world evidence demonstrates an appropriate atrial fibrillation population for hybrid convergent approach versus stand-alone cryoballoon ablation: A long-term safety and efficacy study.

INTRODUCTION: A hybrid convergent approach (endocardial and epicardial ablation) demonstrated superior effectiveness in a recent randomized study for long-standing persistent atrial fibrillation (LSPAF). Yet, there is a lack of real-world, long-term evidence as to which patients are best candidates for a hybrid convergent approach compared to standard endocardial cryoballoon pulmonary vein isolation (CB PVI). METHODS AND RESULTS: This single-center, retrospective analysis spanning from 2010 to 2015 compared two distinctly different atrial fibrillation (AF) cohorts; one treated with stand-alone cryoablation and one treated with a hybrid convergent approach. Baseline characteristics described candidates for each approach. The following criteria were utilized to determine CB PVI candidacy: (1) paroxysmal AF (PAF) (stage 3A) with failed class I/III antiarrhythmic drug (AAD) or (2) persistent/LSPAF (stage 3B/3C/3D) with failed class I/III AAD unwilling to undergo hybrid procedure. Selection criteria for the hybrid procedure included: (1) PAF refractory to both class I/III AAD and prior CB PVI (stage 3D) or (2) persistent/LSPAF (stage 3B/3C/3D) with failed class I/III AAD agreeable to hybrid procedure. Prior sternotomy was excluded. Serial electrocardiograms and continuous monitoring evaluated primary efficacy outcome of time-to-first recurrence of atrial arrhythmia after a 90-day blanking period. Secondary outcomes were procedure-related complications and AAD use (at discharge, 12, and 36 months). Kaplan-Meier methods evaluated arrhythmia recurrence. Of 276 patients, 197 (64.2 ± 10.6 years old; 66.5% male; 74.1% 3A-PAF; 18.3% 3B/3D-persistent AF; 1.0% 3C-LSPAF; 6.6% undetermined) underwent CB PVI and 79 (61.4 ± 8.1 years old; 83.5% male; 41.8% 3D-PAF; 45.5% 3B/3D-persistent AF; 12.7% 3C/3D-LSPAF) underwent hybrid procedure. Arrhythmia freedom through 36 months was 55.2% for CB PVI and 50.4% for hybrid (p = .32). Class I AAD utilization at discharge occurred in 38 (19.3%) patients in the CB PVI group and 5 (6.3%) patients in the hybrid group (p = .01). CB PVI class I AAD utilization at 12 months occurred in 14 (9.0) patients versus 0 patients for hybrid convergent (p = .004). Patients with one or more adverse event were as follows: two (1.0%) in the CB PVI group (both transient phrenic nerve palsy) and three (3.7%) in the hybrid group (two with significant bleeding and one with wound infection) (p = .14). CONCLUSION: This study demonstrated that patients with more complex forms of AF (3D-PAF or 3B/3C/3D-persistent/LSPAF) could be well managed with a convergent approach. In a real-world evaluation, outcomes match safety and efficacy thresholds achieved for patients with earlier, less complex AF etiologies treated by CB PVI alone.

A Retrospective Look at Patient, Procedural, and Follow-up Characteristics Associated With WATCHMAN Implantation.

BACKGROUND: Persons with atrial fibrillation (AF) are at risk for stroke. Atrial fibrillation-related strokes most often result for emboli arising from the left atrial appendage (LAA). Stroke prevention includes the use of anticoagulants and/or antiplatelets. These medications can result in bleeding complications. An alternative to anticoagulants is the WATCHMAN device, which is delivered in the left atria resulting in closure of LAA. OBJECTIVE: The aim of this study was to describe patient, procedural, and follow-up characteristics in patients who have undergone WATCHMAN implantation. METHODS: This study used a retrospective design to review data previously collected and entered into the National Cardiovascular Data Registry database. RESULTS: During a 2-year period, 41 patients underwent the WATCHMAN procedure at our facility. The most common indication for the procedure in this population of patients with nonvalvular AF on oral anticoagulants was bleeding in the gastrointestinal or genitourinary systems. (Gastrointestinal/genitourinary bleed does not limit candidacy for surgical closure of the LAA.) There was only 1 postprocedure adverse event that included a groin hematoma. A transesophageal echocardiogram at 45 days indicated that the LAA seal showed no leak or flow around the device or a leak less than 5 mm. At 1 year, 95% (n = 36) of patients were only taking a single antiplatelet drug with aspirin. Eight patients were on a single antiplatelet medication at the time of follow-up 2 years after the procedure. DISCUSSION: A skilled team including a designated AF clinical nurse specialist contributed to program success measured by efficient placement of the WATCHMAN device and discontinuation of anticoagulation.

Initial Psychometric Testing of the Knowledge About Atrial Fibrillation and Self-Management Survey.

BACKGROUND: Guidelines endorse educating patients to self-manage atrial fibrillation (AF) to mitigate AF-related adverse events contributing to personal and societal burden. Published interventions to improve patients' knowledge about AF and self-management are emerging, but evaluations of interventions are limited by lack of a psychometrically sound instrument to measure learning outcomes. OBJECTIVE: We report results of initial psychometric testing of the Knowledge about Atrial Fibrillation and Self-Management (KAFSM) survey. METHODS: Participants (N = 383), from midwest and southeast medical centers, completed the KAFSM survey. Content validity was evaluated by expert review. Construct validity was evaluated using the Pearson correlation procedure for convergent validity with the Knowledge about Atrial Fibrillation test and independent t test for known groups. Factor analysis using principal axis factoring was performed with a tetrachoric matrix. The Kuder-Richardson procedure was used to determine internal consistency reliability. RESULTS: A content validity index of 0.86 resulted from expert review. A positive (r = 0.60) correlation between the KAFSM survey and Knowledge about Atrial Fibrillation test demonstrated convergent validity. Higher KAFSM scores (difference, 3.28; t = 6.44, P < .001) observed in participants who underwent AF ablation compared with those with an AF diagnosis of less than or equal to 6 months supported known groups validity. Factor analysis revealed a single-factor structure explaining 35% of the variance. The Kuder-Richardson coefficient was 0.86. CONCLUSIONS: The KAFSM survey demonstrates content and construct validity and internal consistency reliability. Implementation of the KAFSM in the clinical setting will permit evaluation of the feasibility of its use and value to assess learning outcomes of AF education.