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Background: The ganglionated plexuses (GPs) of the intrinsic cardiac autonomic system may play a role in atrial fibrillation (AF).Objective: We hypothesized that ablating the ectopy-triggering GPs (ET-GPs) prevents AF.Methods: GANGLIA-AF (ClinicalTrials.gov identifier NCT02487654) was a prospective, randomized, controlled, 3-center trial. ET-GPs were mapped using high frequency stimulation, delivered within the atrial refractory period and ablated until nonfunctional. If triggered AF became incessant, atrioventricular dissociating GPs were ablated. We compared GP ablation (GPA) without pulmonary vein isolation (PVI) against PVI in patients with paroxysmal AF. Follow-up was for 12 months including 3-monthly 48-hour Holter monitors. The primary end point was documented ≥30 seconds of atrial arrhythmia after a 3-month blanking period.Results: A total of 102 randomized patients were analyzed on a per-protocol basis after GPA (n = 52; 51%) or PVI (n = 50; 49%). Patients who underwent GPA had 89 ± 26 high frequency stimulation sites tested, identifying a median of 18.5% (interquartile range 16%-21%) of GPs. The radiofrequency ablation time was 22.9 ± 9.8 minutes in GPA and 38 ± 14.4 minutes in PVI (P < .0001). The freedom from ≥30 seconds of atrial arrhythmia at 12-month follow-up was 50% (26 of 52) with GPA vs 64% (32 of 50) with PVI (log-rank, P = .09). ET-GPA without atrioventricular dissociating GPA achieved 58% (22 of 38) freedom from the primary end point. There was a significantly higher reduction in antiarrhythmic drug usage postablation after GPA than after PVI (55.5% vs 36%; P = .05). Patients were referred for redo ablation procedures in 31% (16 of 52) after GPA and 24% (12 of 50) after PVI (P = .53).Conclusion: GPA did not prevent atrial arrhythmias more than PVI. However, less radiofrequency ablation was delivered to achieve a higher reduction in antiarrhythmic drug usage with GPA than with PVI. [ABSTRACT FROM AUTHOR]

Background: Experience with retrieval of a Watchman left atrial (LA) appendage (LAA) closure device (WD) is limited. An embolized or grossly malpositioned WD warrants retrieval to minimize the risk of thromboembolic complications and vascular occlusion.Objective: The purpose of this study was to report approaches for percutaneous retrieval of a WD from multicenter experience.Methods: Data on successful WD retrievals were obtained from high-volume operators. Data included clinical characteristics; structural characteristics of the LA and LAA; and procedural details of the deployment and retrieval procedure, type of retrieval (immediate: during the same procedure; delayed: during a separate procedure after the successful deployment), equipment used, complications, and postretrieval management.Results: Ten successful percutaneous and 1 surgical retrievals comprised this study. Seven patients had immediate retrieval, while 4 had delayed retrieval. The median duration before delayed retrieval was 45 days (range 1-45 days). The median LAA diameter and size of a successfully deployed WD was 16 mm (range 14-24 mm) and 21 mm (range 21-30 mm), respectively. A WD was retrieved from the LA (n = 1), LAA (n = 2), left ventricle (n = 2), and aorta (n = 6). The reason for retrieval from the LAA was inadequate deployment, resulting in a significant peri-device leak. Retrieval from the LA or LAA was successfully performed using snares (n = 2) and a Raptor grasping device (n = 1). Retrieval from the left ventricle was achieved with a snare (n = 1) and surgery (n = 1). Retrieval from the aorta required snares (n = 5) and retrieval forceps (n = 1). Five patients were successfully reimplanted with a larger size WD. The only complication during percutaneous retrieval was a pseudoaneurysm.Conclusion: Retrieval of an embolized or malpositioned WD is feasible, and familiarity with snares and grasping tools can facilitate a successful removal. [ABSTRACT FROM AUTHOR]

Background: Implantable loop recorder (ILR) is preferred strategy for prolonged rhythm monitoring.Objective: The purpose of this study was to report the incidence and causes of false-positive (FP) diagnoses during remote monitoring with ILR.Methods: During a 4-week study period, all consecutive remote transmissions in patients with ILR (Reveal LINQ, Medtronic) implanted for atrial fibrillation (AF) surveillance, cryptogenic stroke (CS), and syncope were reviewed. A nurse specializing in device management and an electrophysiologist adjudicated all transmissions. Primary endpoint of the study was incidence of FP in patients with AF, CS, and syncope.Results: A total of 695 remote transmissions (scheduled downloads: 414; Alerts: 281) sent from 559 patients were adjudicated. The majority of patients had ILR for AF surveillance (n = 321), followed by CS (n =168) and syncope (n = 70) with nominal programming for rhythm diagnosis. Incidence of FP transmissions during the study period was 46%, 86%, and 71% in patients with AF, CS, and syncope, respectively. Incidence of FP transmissions was higher in patients with CS and syncope than in patients with AF (P <.001). For scheduled transmissions, primary causes of FP were signal dropout and undersensing; for alert transmissions, primary reasons for FP were premature atrial and ventricular ectopy.Conclusion: Incidence of FP during remote monitoring with nominal settings on this ILR was substantial, ranging from 46% to 86% depending on the indication for implantation. Adjudication of these transmissions required a considerable time commitment from electrophysiologists and device clinic personnel but would be required to avoid misdiagnosis and potential errors in clinical management. [ABSTRACT FROM AUTHOR]

Background Left atrial (LA) strain (ε) and ε 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 ε 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 ε 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. ε 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 <.023). Conclusion LAA exclusion seems to improve mechanical function of the LA and results in reverse LA remodeling. [ABSTRACT FROM AUTHOR]

Background: Experience with retrieval of the Micra transcatheter pacing system (TPS) is limited because of its relatively newer technology. Although abandonment of the TPS at end of life is recommended, certain situations such as endovascular infection or device embolization warrant retrieval.Objective: The purpose of this study was to report the worldwide experience with successful retrieval of the Micra TPS.Methods: A list of all successful retrievals of the currently available leadless pacemakers (LPs) was obtained from the manufacturer of Micra TPS. Pertinent details of retrieval, such as indication, days postimplantation, equipment used, complications, and postretrieval management, were obtained from the database collected by the manufacturer. Other procedural details were obtained directly from the operators at each participating site.Results: Data from the manufacturer consisted of 40 successful retrievals of the Micra TPS. Operators for 29 retrievals (73%) provided the consent and procedural details. Of the 29 retrievals, 11 patients underwent retrieval during the initial procedure (immediate retrieval); the other 18 patients underwent retrieval during a separate procedure (delayed retrieval). Median duration before delayed retrieval was 46 days (range 1-95 days). The most common reason for immediate retrieval was elevated pacing threshold after tether removal. The most common reasons for delayed retrieval included elevated pacing threshold at follow-up, endovascular infection, and need for transvenous device. Mean procedure duration was 63.11 ± 56 minutes. All retrievals involved snaring via a Micra TPS delivery catheter or steerable sheath. No serious complications occurred during the reported retrievals.Conclusion: Early retrieval of the Micra TPS is feasible and safe. [ABSTRACT FROM AUTHOR]

Background: The perioperative anticoagulation management during subcutaneous implantable cardioverter-defibrillator (S-ICD) implantation is still evolving.Objective: The purpose of this study was to assess whether it is safe to perform S-ICD implantation with uninterrupted warfarin.Methods: This is a single-center retrospective review of patients undergoing S-ICD implantation between October 1, 2012 and June 30, 2017. One hundred thirty-seven patients underwent successful S-ICD implantation during the study period. The most common indication for implantation was primary prevention of sudden cardiac death. In 24 (17.5%) patients, warfarin was continued without any interruption (warfarin group). In 113 (82.5%) patients, no warfarin was used in the perioperative period (nonwarfarin group). The incidence of clinically significant lateral pocket hematoma was compared in the 2 groups.Results: The mean international normalized ratio was 1.83 ± 0.47 in the warfarin group and 1.09 ± 0.18 in the nonwarfarin group. A total of 8 patients developed a hematoma at the lateral pocket. No patient developed a hematoma at the parasternal pockets. Six patients (25%) in the warfarin group and 2 (1.5%) in the nonwarfarin group developed a significant lateral pocket hematoma (P = .001). The mean length of stay was longer in the warfarin group (1.23 ± 0.46 days) than in the nonwarfarin group (1.02 ± 0.18 days) (P = .0008). An international normalized ratio of >1.8 predicted the risk of hematoma. The concomitant use of dual antiplatelet therapy did not increase the risk of hematoma. None of the patients with a hematoma developed infection or required hematoma evacuation.Conclusion: Uninterrupted warfarin in the perioperative period during S-ICD implantation is associated with an increased risk of significant lateral pocket hematoma that results in prolonged hospital stay. [ABSTRACT FROM AUTHOR]

Background: During early experience with subcutaneous implantable cardioverter-defibrillators (S-ICD), several patients had inappropriate shocks from T-wave oversensing (TWOS) during exercise. This prompted some operators to perform routine treadmill exercise tests after implantation of S-ICD to screen for TWOS. Meanwhile, improvements have been made in the detection algorithms by the manufacturer.Objective: To assess whether routine treadmill exercise post S-ICD implantation is warranted.Methods: Patients undergoing S-ICD implantation from October 2012 to December 2016 who were able to complete a treadmill exercise were included in the study. The amplitude of R and T waves as assessed by the device programmer at rest and peak exercise was calculated and incidence of TWOS recorded.Results: Eighty-seven patients with complete treadmill exercise test data were included in the final analysis. The majority of the patients received S-ICD for primary prevention. Nine percent of the included patients had hypertrophic obstructive cardiomyopathy. During treadmill exercise, there was significant increase in the heart rate from rest (77 ± 14 beats per minute) to peak exercise (133 ± 14 beats per minute; P < .0001). There was no significant difference between R-wave amplitude at rest (2 ± 0.77 mV) and peak exercise (1.88 ± 0.94 mV; P = .36). Similarly, there was no significant difference between T-wave amplitude at rest (0.27 ± 0.19 mV) and peak exercise (0.33 ± 0.23 mV; P = .06). The incidence of TWOS during exercise was zero.Conclusions: With current screening and detection algorithms for S-ICD, routine treadmill exercise does not result in additional discrimination of patients susceptible to TWOS. [ABSTRACT FROM AUTHOR]

Background: In the stroke prevention trials of left atrial appendage closure with the Watchman device (Boston Scientific), a postimplantation antithrombotic regimen of 6 weeks of warfarin was used.Objective: Given the clinical complexity of warfarin use, the purpose of this study was to study the relative feasibility and safety of using non-warfarin oral anticoagulants (NOACs) instead of warfarin during the peri- and initial postimplantation periods after Watchman implantation.Methods: This was a retrospective multicenter study of consecutive patients undergoing Watchman implantation and receiving peri- and postprocedural NOACs or warfarin. Transesophageal echocardiography or chest computed tomography was performed between 6 weeks and 4 months postimplant to assess for device-related thrombosis. Bleeding and thromboembolic events also were evaluated at the time of follow-up.Results: In 5 centers, 214 patients received NOACs (46% apixaban, 46% rivaroxaban, 7% dabigatran, and 1% edoxaban) in either an uninterrupted (82%) or a single-held-dose (16%) fashion. Compared to a control group receiving uninterrupted warfarin (n = 212), the rates of periprocedural complications, including bleeding events, were similar (2.8% vs 2.4%, P = 1). At follow-up, the rates of device-related thrombosis (0.9% vs 0.5%, P = 1), composite of thromboembolism or device-related thrombosis (1.4% vs 0.9%, P = 1), and postprocedure bleeding events (0.5% vs 0.9%, P = .6) also were comparable between the NOAC and warfarin groups.Conclusion: NOACs proved to be a feasible peri- and postprocedural alternative regimen to warfarin for preventing device-related thrombosis and thromboembolic complications expected early after appendage closure with the Watchman device, without increasing the risk of bleeding. [ABSTRACT FROM AUTHOR]

Background: Published studies of epicardial ligation of left atrial appendage (LAA) have reported discordant results.Objective: The purpose of this study was to delineate the safety and efficacy of LAA closure with the LARIAT device.Methods: 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.Results: 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 requiring >2 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 of >5 mm.Conclusion: 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. [ABSTRACT FROM AUTHOR]

The suboptimal outcomes of atrial fibrillation (AF) ablation have been attributed to lack of transmural lesions during pulmonary vein isolation. The advent of contact force (CF) sensing technology enables real-time assessment of the applied force at the catheter-tissue interface and increases the chances of transmural lesions. We sought to perform a meta-analysis of data from eligible studies to delineate the true impact of CF technology. Database searches through April 2015 identified 9 eligible studies (enrolling 1148 patients). The relative risk of AF recurrence at follow-up was used as the primary end point and assessed with random-effects meta-analysis. Radiofrequency (RF) duration, total procedure length, and fluoroscopy exposure were assessed as secondary outcomes using weighted mean difference with the random-effects model. Compared with standard technology, the use of CF technology showed a 37% reduction (relative risk 0.63; 95% confidence interval 0.44–0.91; P = .01) in AF recurrence at a median follow-up of 12 months and a 7.3-minute reduction (95% confidence interval −14.05 to −0.55; P = .03) in RF use during ablation. There was no significant difference in total procedure length and fluoroscopy exposure between the 2 groups. In conclusion, this meta-analysis shows that the use of CF technology decreases AF recurrence at a median follow-up of 12 months and also led to decreased use of RF during ablation. There was no difference in total procedure length and fluoroscopy exposure. [ABSTRACT FROM AUTHOR]

Background The left atrial appendage (LAA) is a well-known source of atrial arrhythmia and atrial fibrillation (AF). Objective The purpose of this study was to determine whether LAA exclusion using the LARIAT device would decrease AF burden. Methods 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. Results 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). Conclusion 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. [ABSTRACT FROM AUTHOR]

Background: Localizing the origin of outflow tract ventricular tachycardias (OTVT) is hindered by lack of accuracy of electrocardiographic (ECG) algorithms and infrequent spontaneous premature ventricular complexes (PVCs) during electrophysiological studies. Objectives: To prospectively assess the performance of noninvasive electrocardiographic mapping (ECM) in the pre-/periprocedural localization of OTVT origin to guide ablation and to compare the accuracy of ECM with that of published ECG algorithms. Methods: Patients with symptomatic OTVT/PVCs undergoing clinically indicated ablation were recruited. The OTVT/PVC origin was mapped preprocedurally by using ECM, and 3 published ECG algorithms were applied to the 12-lead ECG by 3 blinded electrophysiologists. Ablation was guided by using ECM. The OTVT/PVC origin was defined as the site where ablation caused arrhythmia suppression. Acute success was defined as abolition of ectopy after ablation. Medium-term success was defined as the abolition of symptoms and reduction of PVC to less than 1000 per day documented on Holter monitoring within 6 months. Results: In 24 patients (mean age 50 ± 18 years) recruited ECM successfully identified OTVT/PVC origin in 23/24 (96%) (right ventricular outflow tract, 18; left ventricular outflow tract, 6), sublocalizing correctly in 100% of this cohort. Acute ablation success was achieved in 100% of the cases with medium-term success in 22 of 24 patients. PVC burden reduced from 21,837 ± 23,241 to 1143 ± 4039 (P < .0001). ECG algorithms identified the correct chamber of origin in 50%–88% of the patients and sublocalized within the right ventricular outflow tract (septum vs free-wall) in 37%–58%. Conclusions: ECM can accurately identify OTVT/PVC origin in the left and the right ventricle pre- and periprocedurally to guide catheter ablation with an accuracy superior to that of published ECG algorithms. [Copyright &y& Elsevier]

Background: Left atrial (LA) strain (ε) and ε 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 ε 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 ε 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. ε 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 <.023).Conclusion: LAA exclusion seems to improve mechanical function of the LA and results in reverse LA remodeling. [ABSTRACT FROM AUTHOR]