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Background Single-chamber leadless pacemakers (LPs) have been shown to be an effective alternative to conventional transvenous pacemakers (CTPs), but their benefit in the context of cardioinhibitory vasovagal syncope (CI-VVS) is unknown. Objective The purpose of this study was to evaluate the safety and efficacy of LP compared with dual-chamber CTP for CI-VVS. Methods We conducted a multicenter, retrospective study comparing patients who received LP or dual-chamber CTP for drug-refractory CI-VVS. CI-VVS was diagnosed clinically and supported by cardiac monitoring and head-up tilt table testing. The primary efficacy endpoint was freedom from syncope during follow-up. Secondary endpoints included device efficacy and safety estimated by device-related major and minor adverse events (AEs). Results Seventy-two patients (24 LP, 48 CTP; age 32 ± 5.5 years; 90% female; syncope frequency 7.6 ± 3.4 per year) were included. At 1 year, 91% of patients (22/24) in the LP group and 94% of patients (43/48) in the CTP group met the primary efficacy endpoint (P = .7). Device efficacy endpoint was met in 92% of the LP group and 98% of the CTP group (P = .2). Early major AEs occurred in 2 of 24 in the LP group and 3 of 48 in the CTP group (P = .4). Late major AEs occurred in 0 of 24 in the LP group and 2 of 48 in the CTP group (P = 1). Conclusion In patients with CI-VVS, single-chamber LP demonstrated equivalent efficacy in reducing syncopal events compared to dual-chamber CTP, with a similar safety profile.

Background Watchman and Lariat left atrial appendage (LAA) occlusion devices are associated with LAA leaks postdeployment. Objective The purpose of this study was to compare the incidence, characteristics, and clinical significance of these leaks. Methods We performed a multicenter prospective observational study of all patients who underwent LAA closure. Baseline, procedural, and imaging variables along with LAA occlusion rates at 30–90 days and 1-year postprocedure were compared. Results A total of 478 patients (219 with the Watchman device and 259 with the Lariat device) with successful implants were included. Patients in the Lariat group had a higher CHADS 2 (congestive heart failure, hypertension, age >74 years, diabetes, stroke) score and a larger left atrium and LAA. A total of 79 patients (17%) had a detectable leak at 1 year. More patients in the Watchman group had a leak compared with those in the Lariat group (46 [21%] vs 33 [14%]; P = .019). All the leaks were eccentric (edge effect) in the Watchman group and concentric (gunny sack effect) in the Lariat group. The size of the leak was larger in the Watchman group than in the Lariat group (3.10 ± 1.5 mm vs 2.15 ± 1.3 mm; P = .001). The Watchman group had 1 device embolization requiring surgery and 2 pericardial effusions requiring pericardiocentesis. In the Lariat group, 4 patients had cardiac tamponade requiring urgent surgical repair. Three patients in each group had a cerebrovascular accident and were not associated with device leaks. Conclusion The Lariat device is associated with a lower rate of leaks at 1 year as compared with the Watchman device, with no difference in rates of cerebrovascular accident. There was no correlation between the presence of residual leak and the occurrence of cerebrovascular accident.

Background The fibrous capsule around cardiac implantable device generators is known to promote bacterial colonization and latent infection. Removal of the capsule during device replacement procedures may reduce infection rates but may increase hemorrhagic complications. Objective The purpose of this study was to evaluate the effect of pocket capsule decortication procedure on infection and bleeding rates in patients undergoing device replacement procedures. Methods In a prospective randomized single-blind control study, patients undergoing device replacement, upgrade, or lead extraction were randomized to Group A "with pocket revision" (n = 131) and group B "without pocket revision" (n = 127). Deep and superficial infection rates, bleeding, and prolonged serous drainage were assessed during 12 months of follow-up. Data were analyzed according to intention-to-treat principle. Results A total of 258 patients were enrolled in the study. Rates of generator change, upgrade, and lead extraction/replacement were similar between both groups. There was no incidence of deep infection in either group at 12-month follow-up. There was no significant difference in the incidence of superficial infection between groups (1.5% vs 4.7%, P = .13) during 12-month follow-up. There was a significant increase in acute hematoma formation in group A compared to group B (6.1% vs 0.8%, P = .03). Two patients in group A had to undergo hematoma evacuation. Conclusion There was increased incidence of hematoma formation in group A with no effect on infection rates. Our study suggests that there is no benefit to performing empiric pocket revision.

Background Left atrial (LA) strain (e) and e rate (SR) analysis by 2-dimensional speckle tracking echocardiography is a novel method for functional assessment of the LA. Objective The purpose of this study was to determine the impact of left atrial appendage (LAA) exclusion by Lariat epicardial ligation on mechanical function of the LA by performing e and SR analysis before and after the procedure. Methods A total of 66 patients who underwent successful LAA exclusion were included in the study. Of these 66 patients, 32 had adequate paired data for e and SR analysis. SR during ventricular systole (LA-SRs) represents LA reservoir function, and SR during early ventricular diastole (LA-SRe) represents LA conduit function. e and SR were determined from apical 4- and 2-chamber views using the electrocardiographic QRS as a reference point. LA volume index as surrogate for LA remodeling was measured from apical views. Results Mean patient age was 70 ± 9.2 years. LAA ligation resulted in improved reservoir function (LA-SRs: pre 0.72, confidence interval [CI] 0.63–0.83 vs post 0.81, CI 0.73–0.98; P = .043) and conduit function (LA-SRe: pre 0.74, CI 0.67–0.99 vs post 0.89, CI 0.82–1.07; P = .025). LA volume index improved significantly with the Lariat (pre 35.4, CI 29.4–37.2 vs post 29.2, CI 28.2–35.9; P Conclusion LAA exclusion seems to improve mechanical function of the LA and results in reverse LA remodeling.

Background Atrioventricular node (AVN) ablation and permanent pacing is an established strategy for rate control in the management of symptomatic atrial fibrillation (AF). Leadless pacemakers (LPs) can overcome some of the short-term and long-term limitations of conventional transvenous pacemakers (CTPs). Objectives The purpose of this study was to compare the feasibility and safety of LP with those of single-chamber CTP in patients with AF undergoing AVN ablation. Methods We conducted a multicenter observational study of patients undergoing AVN ablation and pacemaker implantation (LP vs single-chamber CTP) between February 1, 2014 and November 15, 2016. The primary efficacy end points were acceptable sensing (R wave amplitude ≥5.0 mV) and pacing thresholds (≤2.0 V at 0.4 ms) at follow-up. Safety end points included device-related major and minor (early 1 month) adverse events. Results A total of 127 patients with LP (n = 60) and CTP (n = 67) were studied. The median follow-up was 12 months (interquartile range 12–18 months). Ninety-five percent of the LP group and 97% of the CTP group met the primary efficacy end point at follow-up (57 of 60 vs 65 of 67; P = .66). There was 1 major adverse event (loss of pacing and sensing) in the LP group and 2 (lead dislodgement) in the CTP group (1 of 60 vs 2 of 67; P = 1.00). There were 6 minor adverse events (5 early and 1 late) in the LP group and 3 (early) in the CTP group (6 of 60 vs 3 of 67; P = .30). Conclusion Our results demonstrate the feasibility and safety of LP compared with CTP in patients undergoing AVN ablation for AF.

The left atrial appendage (LAA) is a well-known source of atrial arrhythmia and atrial fibrillation (AF).The purpose of this study was to determine whether LAA exclusion using the LARIAT device would decrease AF burden.A total of 50 patients with AF and cardiac implantable electronic devices who underwent successful LAA exclusion were enrolled in this prospective observational study. AF burden before LAA exclusion (baseline) and 3 and 12 months after exclusion was assessed by device interrogation.AF burden at 3-month follow-up (42% ± 34%) was significantly lower compared to baseline (76% ± 33%, P.0001). The reduction in AF burden was sustained at 12 months (59% ± 26%, P.001). Subgroup analysis revealed that AF burden at 3-month follow-up was similarly reduced in both paroxysmal AF (n = 19) and nonparoxysmal AF (n = 31). However, there was no reduction in AF burden in patients with paroxysmal AF at 12 months. AF burden in patients with known AF triggers in the LAA (n = 9) was significantly reduced at 3 months (52% ± 35%) and 12 months (42% ± 19%) compared to respective baseline (84 ± 31%, P.0001).LAA exclusion appears to reduce AF burden. The presence of AF triggers in the LAA appears to be the strongest predictor of AF reduction. The study underscores the role of the LAA in arrhythmogenesis for AF and highlights the complementary role of LAA exclusion in restoration of normal sinus rhythm.

Patients with prosthetic valves have a high prevalence of atrial fibrillation (AF). We report a multicenter experience of performing pulmonary vein antral isolation (PVAI) in this challenging, high-risk cohort of patients.The purpose of this study was to assess the feasibility, safety, and efficacy of radiofrequency (RF) ablation for sinus rhythm restoration in AF patients with mitral or aortic mechanical prosthetic valves.A total of 50 patients with prosthetic valves (group I) who underwent RF ablation for AF between January 1, 2007, and April 30, 2009, were identified prospectively at four tertiary care centers. A matched group of 50 patients (group II) acted as controls.Total procedural time (199.4 ± 49 minutes vs 166.6 ± 27.5 minutes, P.001) and fluoroscopy time (60 ± 17 minutes vs 53.8 ± 6.8 minutes, P.01) were prolonged, with a higher incidence of atrial flutter at 3 months in group I (18% vs 6%, P = .1) compared to group II. At 12 months, 80% of patients in the valve group were in sinus rhythm after an average of 1.3 procedures, and 82% of controls were in sinus rhythm after an average 1.2 procedures (P = .9). There was a trend toward a higher nonfatal complication rate in the valve group than in the control group (8% vs 4%, P = .1).In patients with prosthetic valves, RF ablation for AF is feasible, safe, and efficacious, with a trend toward a higher nonfatal complication rate and an increased rate of postablation atrial flutter.

Published studies of epicardial ligation of left atrial appendage (LAA) have reported discordant results.The purpose of this study was to delineate the safety and efficacy of LAA closure with the LARIAT device.This is a multicenter registry of 712 consecutive patients undergoing LAA ligation with LARIAT at 18 US hospitals. The primary end point was successful suture deployment, no leak by intraprocedural transesophageal echocardiography (TEE), and no major complication (death, stroke, cardiac perforation, and bleeding requiring transfusion) at discharge. A leak of 2-5 mm on follow-up TEE was the secondary end point.LARIAT was successfully deployed in 682 patients (95.5%). A complete closure was achieved in 669 patients (98%), while 13 patients (1.8%) had a trace leak (2 mm). There was 1 death related to the procedure. Ten patients (1.44%) had cardiac perforation necessitating open heart surgery, while another 14 (2.01%) did not need surgery. The risk of cardiac perforation decreased significantly after the introduction of a micropuncture (MP) needle for pericardial access. Delayed complications (pericarditis requiring2 weeks of treatment with nonsteroidal anti-inflammatory drugs/colchicine and pericardial and pleural effusion after discharge) occurred in 34 (4.78%) patients, and the risk decreased significantly with the periprocedural use of colchicine. Follow-up TEE (n = 480) showed a leak of 2-5 mm in 6.5% and a thrombus in 2.5%. One patient had a leak of5 mm.LARIAT effectively closes the LAA and has acceptable procedural risks with the evolution of the use of the micropuncture needle for pericardial access and the use of colchicine for mitigating the postinflammatory response associated with LAA ligation and pericardial access.