Rationale and design for AMPLATZER Amulet Left Atrial Appendage Occluder IDE randomized controlled trial (Amulet IDE Trial).

The Amulet IDE Trial is an ongoing, prospective, randomized, multi-national trial, designed to evaluate the safety and effectiveness of the AMPLATZER Amulet Left Atrial Appendage Occluder for stroke prevention in comparison to the WATCHMAN Left Atrial Appendage Closure Device in patients with non-valvular atrial fibrillation. METHODS: Non-valvular atrial fibrillation patients at high risk of stroke (CHADS2 score ≥2 or a CHA2DS2-VASc score of ≥3) who are suitable candidates for left atrial appendage occlusion (LAAO) will be fully informed and requested to participate in the trial. A total of 1878 patients at up to 150 sites worldwide will be randomized in a 1:1 ratio between the AMPLATZER Amulet device (investigational) and the Boston Scientific WATCHMAN device (control). Each patient will be followed for 5 years, with follow-up assessments at discharge, 45 days, 3, 6, 9, 12, 18, and 24 months and then annually. The trial has three primary endpoints: A composite of procedure-related complications, or all-cause death, or major bleeding through 12 months (safety); a composite of ischemic stroke or systemic embolism through 18 months (effectiveness); and effective device LAAO, defined as residual jet around the device ≤5 mm at the 45-day visit (mechanism of action). SUMMARY: The Amulet IDE Trial is the first randomized head-to-head LAAO device trial and will provide data for the AMPLATZER Amulet occluder in a population with a high risk of stroke and bleeding.

Performance of an Implantable Cardiac Monitor to Detect Atrial Fibrillation: Results of the DETECT AF Study.

INTRODUCTION: Reliable detection and monitoring of atrial fibrillation (AF) is essential for accurate clinical decision making, which can now be done continuously with the introduction of implantable cardiac monitors (ICM) The DETECT AF study evaluated the performance of the Confirm DM2102 ICM (St. Jude Medical, St. Paul, MN, USA) to accurately detect and monitor AF. METHODS: Ninety patients previously implanted with the ICM and with either suspected or known paroxysmal AF were enrolled at 12 centers in Germany and The Netherlands. At least 2 weeks after ICM implant, patients wore a Holter monitor for 4 days, while the ICM monitored for AF episodes lasting at least 2 minutes. Holter monitor data was analyzed by a blinded, independent core laboratory and compared to the ICM AF detections. Patient and episode sensitivity (SE), specificity (SP), positive predictive value (PPV), and negative predictive (NPV) were calculated using standard analysis and a generalized estimation equation method where appropriate. RESULTS: A total of 79/90 subjects (61% male, 65.7 ± 9.6 years old) were included in the analysis, totaling 6,894 hours of Holter monitoring. Using a per patient analysis SE was 100%, PPV was 64.0%, SP was 85.7%, and NPV was 100%. Using a per episode analysis, SE was 94.0% and PPV was 64.0%. With an AF duration analysis, the SE was 83.9%, PPV was 97.3%, SP was 99.4% with an NPV of 98.5%. CONCLUSION: The SJM Confirm DM2102 can accurately and repeatedly detect paroxysmal AF episodes of at least 2 minutes in length.

Clinical predictors of risk for atrial fibrillation: implications for diagnosis and monitoring.

OBJECTIVE: To create a risk score using clinical factors to determine whom to screen and monitor for atrial fibrillation (AF). PATIENTS AND METHODS: The AF risk score was developed based on the summed odds ratios (ORs) for AF development of 7 accepted clinical risk factors. The AF risk score is intended to assess the risk of AF similar to how the CHA2DS2-VASc score assesses stroke risk. Seven validated risk factors for AF were used to develop the AF risk score: age, coronary artery disease, diabetes mellitus, sex, heart failure, hypertension, and valvular disease. The AF risk score was tested within a random population sample of the Intermountain Healthcare outpatient database. Outcomes were stratified by AF risk score for OR and Kaplan-Meier analysis. RESULTS: A total of 100,000 patient records with an index follow-up from January 1, 2002, through December 31, 2007, were selected and followed up for the development of AF through the time of this analysis, May 13, 2013, through September 6, 2013. Mean ± SD follow-up time was 3106±819 days. The ORs of subsequent AF diagnosis of patients with AF risk scores of 1, 2, 3, 4, and 5 or higher were 3.05, 12.9, 22.8, 34.0, and 48.0, respectively. The area under the curve statistic for the AF risk score was 0.812 (95% CI, 0.805-0.820). CONCLUSION: We developed a simple AF risk score made up of common clinical factors that may be useful to possibly select patients for long-term monitoring for AF detection.

Patients treated with catheter ablation for ventricular tachycardia after an ICD shock have lower long-term rates of death and heart failure hospitalization than do patients treated with medical management only.

BACKGROUND: Ventricular arrhythmias in patients with implantable cardioverter-defibrillators (ICDs) adversely affect outcomes. Antiarrhythmic approaches to ventricular tachycardia (VT) have variable efficacy and may increase risk of ventricular arrhythmias, worsening cardiomyopathy, and death. Comparatively, VT ablation is an alternative approach that may favorably affect outcomes. OBJECTIVE: To further explore the effect on long-term outcomes after catheter ablation of VT, we compared patients with history of ICD shocks who did not undergo ablation, patients with a history of ICD shocks that underwent ablation, and patients with ICDs who had no history of ICD shocks. METHODS: A total of 102 consecutive patients with structural heart disease who underwent VT ablation for recurrent ICD shocks were compared with 2088 patients with ICDs and no history of appropriate shocks and 817 patients with ICDs and a history of appropriate shocks for VT or ventricular fibrillation. Outcomes considered were mortality, heart failure hospitalization, atrial fibrillation, and stroke/transient ischemic attack. RESULTS: The mean age of 3007 patients was 65.4 ± 13.9 years. Over long-term follow-up, 866 (28.8%) died, 681 (22.7%) had a heart failure admission, 706 (23.5%) developed new-onset atrial fibrillation, and 224 (7.5%) had a stroke. The multivariate-adjusted risks of deaths and heart failure hospitalizations were higher in patients with history of ICD shocks who were treated medically than in patients with ICDs and no history of shock (hazard ratio [HR] 1.45; P < .0001 vs HR 2.00; P < .0001, respectively). The multivariate-adjusted risks were attenuated after VT ablation with death and heart failure hospitalization rates similar to those of patients with no shock (HR 0.89; P = .58 vs HR 1.38; P = .09, respectively). A similar nonsignificant trend was seen with stroke/transient ischemic attack. CONCLUSIONS: Patients treated with VT ablation after an ICD shock have a significantly lower risk of death and heart failure hospitalization than did patients managed medically only. The adverse event rates after VT ablation were similar to those of patients with ICDs but without VT.