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Background High adherence to remote monitoring (RM) in pacemaker (PM) patients improves outcomes; however, adherence remains suboptimal. Bluetooth low-energy (BLE) technology in newer-generation PMs enables communication directly with patient-owned smart devices using an app without a bedside console. Objective To evaluate the success rate of scheduled RM transmissions using the app compared to other RM methods. Methods The BlueSync Field Evaluation was a prospective, international cohort evaluation, measuring the success rate of scheduled RM transmissions using a BLE PM or cardiac resynchronization therapy PM coupled with the MyCareLink Heart app. App transmission success was compared to 3 historical “control” groups from the Medtronic de-identified CareLink database: (1) PM patients with manual communication using a wand with a bedside console (PM manual transmission), (2) PM patients with wireless automatic communication with the bedside console (PM wireless); (3) defibrillator patients with similar automatic communication (defibrillator wireless). Results Among 245 patients enrolled (age 64.8±15.6 years, 58.4% men), 953 transmissions were scheduled through 12 months, of which 902 (94.6%) were successfully completed. In comparison, transmission success rates were 56.3% for PM manual transmission patients, 77.0% for PM wireless patients, and 87.1% for defibrillator wireless patients. Transmission success with the app was superior across matched cohorts based on age, sex, and device type (single vs dual vs triple chamber). Conclusion The success rate of scheduled RM transmissions was higher among patients using the smart device app compared to patients using traditional RM using bedside consoles. This novel technology may improve patient engagement and adherence to RM., Graphical abstract

Objectives STOP AF PAS (Sustained Treatment of Paroxysmal Atrial Fibrillation Post-Approval Study) is the first prospective, multicenter, 3-year study in North America to assess long-term safety and effectiveness of the cryoballoon for treatment of patients with drug-refractory symptomatic pAF. Background The STOP AF PAS was required by the U.S. Food and Drug Administration at the time of approval of the first-generation cryoballoon for the treatment of paroxysmal atrial fibrillation (pAF). The second-generation cryoballoon (CB2) was commercially released shortly after this trial was initiated. Methods The study was nonrandomized. Enrollment was completed with 344 eligible patients undergoing pulmonary vein isolation (PVI) using the CB2. Procedure-related safety and freedom from AF and symptomatic atrial flutter/atrial tachycardia through 3 years were determined. Documented atrial arrhythmias ≥30 s were considered treatment failures. Results Acute PVI was achieved in 99.3% (1,341 of 1,350) of veins. Mean follow-up was 34 ± 7 months. The rate of major complications was 5.8%, including a 3.2% rate of phrenic nerve injury, which resolved in all but 1 patient by 36 months. At 36 months, 11.7% of patients were prescribed antiarrhythmic agents, inclusive of “pill-in-the-pocket” administration. Freedom from AF was 81.6% at 12 months, 73.8% at 24 months, and 68.1% at 36 months. Freedom from AF and symptomatic atrial flutter/atrial tachycardia was 79.0% at 12 months, 70.8% at 24 months, and 64.1% at 36 months. Freedom from a repeat ablation procedure was 80.9% at 36 months. Conclusions PVI using the CB2 was an effective treatment for patients with pAF, with freedom from all atrial arrhythmias of 64% at 36 months. (Sustained Treatment of Paroxysmal Atrial Fibrillation Post-Approval Study [STOP AF PAS]; NCT01456949)

Background— Prospective studies defining the risk associated with pacemaker or implantable cardioverter-defibrillator replacement surgeries do not exist. These procedures are generally considered low risk despite results from recent retrospective series reporting higher rates. Methods and Results— We prospectively assessed predefined procedure-related complication rates associated with elective pacemaker or implantable cardioverter-defibrillator generator replacements over 6 months of follow-up. Two groups were studied: those without (cohort 1) and those with (cohort 2) a planned transvenous lead addition for replacement or upgrade to a device capable of additional therapies. Complications were adjudicated by an independent events committee. Seventy-two US academic and private practice centers participated. Major complications occurred in 4.0% (95% confidence interval, 2.9 to 5.4) of 1031 cohort 1 patients and 15.3% (95% confidence interval, 12.7 to 18.1) of 713 cohort 2 patients. In both cohorts, major complications were higher with implantable cardioverter-defibrillator compared with pacemaker generator replacements. Complications were highest in patients who had an upgrade to or a revised cardiac resynchronization therapy device (18.7%; 95% confidence interval, 15.1 to 22.6). No periprocedural deaths occurred in either cohort, although 8 later procedure-related deaths occurred in cohort 2. The 6-month infection rates were 1.4% (95% confidence interval, 0.7 to 2.3) and 1.1% (95% confidence interval, 0.5 to 2.2) for cohorts 1 and 2, respectively. Conclusions— Pacemaker and implantable cardioverter-defibrillator generator replacements are associated with a notable complication risk, particularly those with lead additions. These data support careful decision making before device replacement, when managing device advisories, and when considering upgrades to more complex systems. Clinical Trial Registration— URL: http://www.clinicaltrials.gov . Unique identifier: NCT00395447.

This pilot study aimed to compare right atrial pacing, intravenous amiodarone and oral beta-blockers in the prevention, time to onset, duration and effect on hospital stay of postoperative atrial fibrillation (AF) after coronary artery bypass graft surgery (CABG) at our center.AF is the most common arrhythmic complication after CABG and is related to increased morbidity, length of hospital stay and costs. Trials with different drugs and other therapeutic modalities including beta-blockers, intravenous amiodarone and override suppression of automatic atrial foci by atrial pacing have shown partial success as preventive measures. However, a comparison between those three interventions has not been reported.Thirty-six consecutive patients that underwent CABG at our institution were randomly assigned to atrial pacing (18 patients) and intravenous amiodarone (18 patients) after baseline clinical, electrocardiographic and hemodynamic assessment. All patients received concomitant oral metoprolol or atenolol right after extubation. Thirty-three patients who had CABG at our center in the previous two months and that only received beta-blockers during their perioperative period served as a control group.The majority of baseline clinical and hemodynamic characteristics were similar in all groups. Only one patient (5.6%) developed AF in the atrial pacing group versus five (27.8%) on amiodarone and six (18.2%) who only received beta-blockers. That finding, however, did not attain statistical significance (p0.05). After adjusting for potential confounders, the odds of occurrence of AF was 77% lower in atrial pacing patients (OR = 0.23; 95% CI: 0.02, 2.20; p = 0.09) and 2.36 times higher in those on amiodarone (95% CI: 0.55, 10.24; P = 0.053) when compared to patients which only received beta blockers. Since only one patient on right atrial pacing developed atrial fibrillation, the analysis of the median time to onset and median duration of atrial fibrillation was restricted to those assigned to amiodarone and those who only received beta-blockers showing no statistically significant differences (p0.05). Although no statistical significance was achieved, the median hospital stay was one-day shorter in the beta-blockers group. Most of the side effects were minor and resolved without sequelae.This pilot study showed a trend in favor of atrial pacing versus intravenous amiodarone or beta-blockers in the prevention of postoperative AF after CABG in our center. Randomization of a larger patient sample would be required in order to ascertain the true value of the observed trend.