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Rupture of the cardiac wall is usually a fatal complication of acute myocardial infarction within the first 2 weeks. However, in certain cases a ruptured ventricular wall is contained by overlying adherent pericardium called pseudoaneurysm, whereas a true aneurysm is one that is caused by scar formation resulting in thinning of the myocardium. The patients with pseudoaneurysm may survive until the aneurysm ruptures. In exceedingly rare instance, the rupture of the myocardium is not transmural but remains circumscribed within the ventricular wall itself, but in communication with the ventricular cavity. This finding is defined as pseudo-pseudoaneurysm. The authors report a case of postinfarction posterobasal pseudo-pseudoaneurysm along with review of the literature on the subject. [ABSTRACT FROM AUTHOR]

Background: Atrial fibrillation (AF) is associated with an increased risk of stroke, yet the limitations of conventional monitoring have restricted our understanding of AF burden risk thresholds. Predictive algorithms incorporating continuous AF burden measures may be useful for predicting stroke. This study evaluated the performance of temporal AF burden trends as predictors of stroke from a large cohort with insertable cardiac monitors., Methods: Using deidentified data from Optum Clinformatics Data Mart (2007-2019) linked with the Medtronic CareLink insertable cardiac monitor database, we identified patients with an insertable cardiac monitor for AF management (n=1197), suspected AF (n=1611), and cryptogenic stroke (n=2205). Daily AF burden was transformed into simple moving averages, and temporal AF burden trends were defined as the comparison of unique simple moving average pairs. Classification trees were used to predict ischemic stroke, and AF burden significance was quantified using bootstrapped mean variable importance., Results: Of 5013 patients (age, 69.2±11.7 years; 50% male; CHA 2 DS 2 -VASc, 3.7±1.9) who met inclusion criteria, 869 had an ischemic stroke over 2 409 437 days total follow-up. Prior stroke or transient ischemic attack (variable importance, 13.13) was the number 1 predictor of future stroke followed by no prior diagnosis of AF (7.35) and AF burden trends in follow-up (2.59). Temporal proximity of AF and risk of stroke differed by device indication (simple moving averages: AF management, <8 days and suspected AF and cryptogenic stroke, 8-21 days). Together, baseline characteristics and AF burden trends performed optimally for the area under the receiver operating characteristic curve (0.73), specificity (0.70), and relative risk (5.00)., Conclusions: AF burden trends may provide incremental prognostic value as leading indicators of stroke risk compared with conventional schemes.

Background: Atrial fibrillation is associated with an increased risk of cardiovascular hospitalization (CVH), which may be triggered by changes in daily burden. Machine learning of dynamic trends in atrial fibrillation burden, as measured by insertable cardiac monitors (ICMs), may be useful in predicting near-term CVH., Methods: Using Optum's deidentified Clinformatics Data Mart Database (2007-2019), linked with the Medtronic CareLink ICM database, we identified patients with >1 days of ICM-detected atrial fibrillation. ICM-detected diagnostic parameters were transformed into simple moving averages over different periods for daily follow-up. A diagnostic trend was defined as the comparison of 2 simple moving averages of different periods for each diagnostic parameter. CVH was defined as any hospital, emergency department, or ambulatory surgical center encounter with a cardiovascular diagnosis-related group or diagnosis code. Machine learning was used to determine which diagnostic trends could best predict patient risk 5 days before CVH., Results: A total of 2616 patients with ICMs met the inclusion criteria (71±11 years; 55% male). Among them, 1998 (76%) had a planned or unplanned CVH over 605 363 days. Machine learning revealed distinct groups: (A) sinus rhythm (reference), (B) below-average burden, (C) above-average burden, and (D) above-average burden with decreasing patient activity. The relative risk was increased in all groups versus the reference (B, 4.49 [95% CI, 3.74-5.40]; C, 8.41 [95% CI, 7.00-10.11]; D, 11.15 [95% CI, 9.10-13.65]), including a 21% increase in CVH detection over prespecified burden thresholds of duration (≥1 hour) and quantity (≥5%). The area under the receiver operating characteristic curve increased from 0.55 when using hourly burden amounts to 0.66 when using burden trends and decreasing patient activity ( P <0.001), a 20% increase in predictive power., Conclusions: Trends in atrial fibrillation were strongly associated with near-term CVH, especially above-average burden coupled with low patient activity. This approach could provide actionable information to guide treatment and reduce CVH.

Background: Percutaneous left atrial appendage occlusion (LAAO) is indicated in patients with atrial fibrillation for whom long-term oral anticoagulation is contraindicated. Whether outcomes are different based on operator certification [interventional cardiology (IC) versus electrophysiology (EP)] is unclear., Objectives: To compare LAAO outcomes by physician certification (EP versus IC) in the NCDR LAAO Registry., Methods: We identified patients from 2020-2022 undergoing implantation of a Watchman FLX or Amulet LAAO device and stratified patients by primary operator certification. Outcomes of interest included: (1) any major adverse event (MAE), 2) mortality, 3) ischemic stroke, and 4) major bleeding during the initial hospitalization and at 45 days. We performed multivariable Cox proportional hazards regression analysis to determine the risk of adverse events by physician certification., Results: A total of 1,638 physicians (57% electrophysiologists) performing 91,711 procedures during the study period were included. EPs were more likely to use intracardiac echocardiography (25.2% vs 9.7%, p<0.001) and had lower radiation total (235 mGy vs 305 mGy, p<0.001). EPs were more likely than ICs to discharge patients on DOAC+aspirin, whereas ICs were more likely to discharge patients on single or dual antiplatelet therapy (all p<0.001). In-hospital death (0.1% vs. 0.1%, p=0.46) and MAE (1.5% vs 1.6%, p=0.42) were similar by physician certification. At 45 days, there was no difference in death [HR death 1.03, 95% CI (0.89-1.2)] or MAE [HR MAE 0.97, 95% CI (0.91-1.03)] after multivariable regression., Conclusions: Contemporary LAAO is safe with low rates of procedural complications and no significant differences in procedural outcomes by operator subspecialty after multivariable adjustment. Continued utilization of technology by EPs and ICs is necessary to allow for broad access to this treatment for eligible patients., (Copyright © 2024. Published by Elsevier Inc.)

Importance: Left atrial appendage elimination may improve catheter ablation outcomes for atrial fibrillation., Objective: To assess the safety and effectiveness of percutaneous left atrial appendage ligation adjunctive to catheter pulmonary vein isolation for nonparoxysmal atrial fibrillation., Design, Setting, and Participants: This multicenter, prospective, open-label, randomized clinical trial evaluated the safety and effectiveness of percutaneous left atrial appendage ligation adjunctive to planned pulmonary vein isolation for nonparoxysmal atrial fibrillation present for less than 3 years. Eligible patients were randomized in a 2:1 ratio to undergo left atrial appendage ligation and pulmonary vein isolation or pulmonary vein isolation alone. Use of a 2:1 randomization ratio was intended to provide more device experience and safety data. Patients were enrolled from October 2015 to December 2019 at 53 US sites, with the final follow-up visit on April 21, 2021., Interventions: Left atrial appendage ligation plus pulmonary vein isolation compared with pulmonary vein isolation alone., Main Outcomes and Measures: A bayesian adaptive analysis was used for primary end points. Primary effectiveness was freedom from documented atrial arrythmias of greater than 30 seconds duration 12 months after undergoing pulmonary vein isolation. Rhythm was assessed by Holter monitoring at 6 and 12 months after pulmonary vein isolation, symptomatic event monitoring, or any electrocardiographic tracing obtained through 12 months after pulmonary vein isolation. Primary safety was a composite of predefined serious adverse events compared with a prespecified 10% performance goal 30 days after the procedure. Left atrial appendage closure was evaluated through 12 months after pulmonary vein isolation., Results: Overall, 404 patients were randomized to undergo left atrial appendage ligation plus pulmonary vein isolation and 206 were randomized to undergo pulmonary vein isolation alone. Primary effectiveness was 64.3% with left atrial appendage ligation and pulmonary vein isolation and 59.9% with pulmonary vein isolation only (difference, 4.3% [bayesian 95% credible interval, -4.2% to 13.2%]; posterior superiority probability, 0.835), which did not meet the statistical criterion to establish superiority (0.977). Primary safety was met, with a 30-day serious adverse event rate of 3.4% (bayesian 95% credible interval, 2.0% to 5.0%; posterior probability, 1.0) which was less than the prespecified threshold of 10%. At 12 months after pulmonary vein isolation, complete left atrial appendage closure (0 mm residual communication) was observed in 84% of patients and less than or equal to 5 mm residual communication was observed in 99% of patients., Conclusions and Relevance: Percutaneous left atrial appendage ligation adjunctive to pulmonary vein isolation did not meet prespecified efficacy criteria for freedom from atrial arrhythmias at 12 months compared with pulmonary vein isolation alone for patients with nonparoxysmal atrial fibrillation, but met prespecified safety criteria and demonstrated high rates of closure at 12 months., Trial Registration: ClinicalTrials.gov Identifier: NCT02513797.

Left atrial appendage occlusion affects systemic coagulation parameters, leading to additional patient-related benefits. The aim of this study was to investigate the differences in coagulation factor changes 6 months after epicardial left atrial appendage occlusion in patients with different LAA morphometries. This is the first study to analyze these relationships in detail. A prospective study of 22 consecutive patients was performed. Plasminogen, fibrinogen, tPA concentration, PAI-1, TAFI and computed tomography angiograms were performed. Patients were divided into subgroups based on left atrial appendage body and orifice diameter enlargement. The results of blood tests at baseline and six-month follow-up were compared. In a population with normal LAA body size and normal orifice diameter size, a significant decrease in analyzed clotting factors was observed between baseline and follow-up for all parameters except plasminogen. A significant decrease between baseline and follow-up was observed with enlarged LAA body size in all parameters except TAFI, in which it was insignificant and plasminogen, in which a significant increase was observed. Occlusion of the left atrial appendage is beneficial for systemic coagulation. Patients with a small LAA may benefit more from LAA closure in terms of stabilizing their coagulation factors associated with potential thromboembolic events in the future.

Background: Cardiac implantable electronic devices (CIEDs) infection remains a serious complication, causing increased morbidity and mortality. Early recognition and escalation to definitive therapy including extraction of the infected device often pose challenges., Objectives: The purpose of this study was to assess U.S.-based physicians current practices in diagnosing and managing CIED infections and explore potential extraction barriers., Methods: An observational survey was performed by the American College of Cardiology including U.S. physicians managing CIEDs from February to March 2022. Sampling techniques and screener questions determined eligibility. The survey featured questions on knowledge and experience with CIED infection patients and case scenarios., Results: Of 387 physicians completing the survey (20% response rate), 49% indicated familiarity with current guidelines regarding CIED infection. Electrophysiologists (EPs) (91%) were more familiar with these guidelines, compared to non-EP cardiologists (29%) and primary care physicians (23%). Only 30% of physicians specified that their institution had guideline-based protocols in place for managing patients with CIED infection. When presented with pocket infection cases, approximately 89% of EPs and 50% of non-EP cardiologists would follow guideline recommendation to do complete CIED system removal, while 70% of primary care physicians did not recommend guideline-directed treatment., Conclusions: There are gaps in familiarity of guidelines as well as the knowledge in practical management of CIED infection with non-extracting physicians. Most institutions lack a definite pathway. Addressing discrepancies, including guideline education and streamlining care or referral pathways, will be a key factor to bridging the gap and improving CIED infection patient outcomes., Competing Interests: This work was supported by Philips Image-Guided Therapy Corporation. The content has not been influenced in any way by its sponsor. Dr Lakkireddy is a consultant for Philips and Abbott and has received honoraria from Abbott, Medtronic, Boston Scientific, and Biosense Webster. Dr Rao has received honoraria from Medtronic, Boston Scientific, and Phillips. Dr Theriot is an employee of American College of Cardiology. Dr Ram is an employee of Philips Image-Guided Therapy Corporation. Dr Gao is an employee of Philips Image-Guided Therapy Corporation. Dr Cheung has received honoraria/consulting fees from Abbott, Biotronik, and Boston Scientific; and has received research support from Boston Scientific and fellowship grant support from Abbott, Biotronik, Boston Scientific, and Medtronic. Dr Birgersdotter-Green has received honoraria from Medtronic, Boston Scientific, Abbott, and Biotronik. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (© 2024 The Authors.)

Aims: Atrial fibrillation (AF) and chronic kidney disease (CKD) often coexist and share an increased risk of thrombo-embolism (TE). CKD concomitantly predisposes towards a pro-haemorrhagic state. Our aim was to evaluate the prognostic value of CKD in patients undergoing percutaneous left atrial appendage occlusion (LAAO)., Methods and Results: A total of 2124 consecutive AF patients undergoing LAAO were categorized into CKD stage 1+2 (n = 1089), CKD stage 3 (n = 796), CKD stage 4 (n = 170), and CKD stage 5 (n = 69) based on the estimated glomerular filtration rate at baseline. The primary endpoint included cardiovascular (CV) mortality, TE, and major bleeding. The expected annual TE and major bleeding risks were estimated based on the CHA2DS2-VASc and HAS-BLED scores. A non-significant higher incidence of major peri-procedural adverse events (1.7 vs. 2.3 vs. 4.1 vs. 4.3) was observed with worsening CKD (P = 0.14). The mean follow-up period was 13 ± 7 months (2226 patient-years). In comparison to CKD stage 1+2 as a reference, the incidence of the primary endpoint was significantly higher in CKD stage 3 (log-rank P-value = 0.04), CKD stage 4 (log-rank P-value = 0.01), and CKD stage 5 (log-rank P-value = 0.001). Left atrial appendage occlusion led to a TE risk reduction (RR) of 72, 66, 62, and 41% in each group. The relative RR of major bleeding was 58, 44, 51, and 52%, respectively., Conclusion: Patients with moderate-to-severe CKD had a higher incidence of the primary composite endpoint. The relative RR in the incidence of TE and major bleeding was consistent across CKD groups., Competing Interests: Conflict of interest: G.B.C. received compensation for teaching purposes and proctoring from Medtronic, Abbott, Biotronik, Boston Scientific, and Acutus Medical. C.dA. received research grants on behalf of the centre from Biotronik, Medtronic, Abbott, LivaNova, Boston Scientific, AtriCure, Philips, and Acutus and compensation for teaching purposes and proctoring from Medtronic, Abbott, Biotronik, Livanova, Boston Scientific, Atricure, Acutus Medical, and Daiichi Sankyo. J.C.G. is a consultant and has received speaker fees from Boston Scientific, Abbott, Medtronic, Biotronik, Pfizer, Bayer, Novartis, Daiichi Sankyo, and Boehringer Ingelheim. M.M. serves as a consultant for Boston Scientific and Abbott. L.D.B. is a consultant for Stereotaxis, Biosense Webster, Boston Scientific, Rhythm Management, and Abbott Medical. J.S. is a consultant for Boston Scientific, Abbott, Baylis, Gore, and FEops, and a proctor for Boston Scientific and Abbott. D.G. is a consultant for Boston Scientific, Abbot, Acutus, and Biosense Webster. A.N. is as a consultant for Abbott, Biosense Webster, Inc., Biotronik, Boston Scientific, Baylis, and Medtronic. The remaining authors have nothing to disclose., (© The Author(s) 2023. Published by Oxford University Press on behalf of the European Society of Cardiology.)

Aims: Prevalent atrial fibrillation (AF) is associated with excess cardiovascular (CV) death (D) and hospitalizations (H) in heart failure (HF) with preserved ejection fraction (pEF). We evaluated if it had an independent role in excess CVD in HFpEF and studied its impact on cause-specific mortality and HF morbidity., Methods and Results: We used propensity score-matched (PSM) cohorts from the TOPCAT Americas trial to account for confounding by other co-morbidities. Two prevalent AF presentations at study entry were compared: (i) subjects with Any AF event by history or on electrocardiogram (ECG) with PSM subjects without an AF event and (ii) subjects in AF on ECG with PSM subjects in sinus rhythm. We analyzed cause-specific modes of death and HF morbidity during a mean follow-up period of 2.9 years. A total of 584 subjects with Any AF event and 418 subjects in AF on ECG were matched. Any AF was associated with increased CVH [hazard ratio (HR) 1.33, 95% confidence interval (CI) 1.11-1.61, P = 0.003], HFH (HR 1.44, 95% CI 1.12-1.86, P = 0.004), pump failure death (PFD) (HR 1.95, 95% CI 1.05-3.62, P = 0.035), and HF progression from New York Heart Association (NYHA) classes I/II to III/IV (HR 1.30, 95% CI 1.04-1.62, P = 0.02). Atrial fibrillation on ECG was associated with increased risk of CVD (HR 1.46, 95% CI 1.02-2.09, P = 0.039), PFD (HR 2.21, 95% CI 1.11-4.40, P = 0.024), and CVH and HFH (HR 1.37, 95% CI 1.09-1.72, P = 0.006 and HR 1.65, 95% CI 1.22-2.23, P = 0.001, respectively). Atrial fibrillation was not associated with risk of sudden death. Both Any AF and AF on ECG cohorts were associated with PFD in NYHA class III/IV HF., Conclusion: Prevalent AF can be an independent risk factor for adverse CV outcomes by its selective association with worsening HF, HFH, and PFD in HFpEF. Prevalent AF was not associated with excess sudden death risk in HFpEF. Atrial fibrillation was also associated with HF progression in early symptomatic HFpEF and PFD in advanced HFpEF., Trial Registration: TOPCAT trial is registered at www.clinicaltrials.gov:identifier NCT00094302., Competing Interests: Conflict of interest: S.S. was a member of the Steering Committee of the TOPCAT trial. The Electrophysiology Research Foundation received a research grant as an investigational site for the TOPCAT trial. All remaining authors have declared no conflicts of interest with the subject of this manuscript., (© The Author(s) 2023. Published by Oxford University Press on behalf of the European Society of Cardiology.)

Infection remains a serious complication associated with the cardiac implantable electronic devices (CIEDs), leading to substantial clinical and economic burden globally. This review assesses the burden of cardiac implantable electronic device infection (CIED-I), evidence for treatment recommendations, barriers to early diagnosis and appropriate therapy, and potential solutions. Multiple clinical practice guidelines recommended complete system and lead removal for CIED-I when appropriate. CIED extraction for infection has been consistently reported with high success, low complication, and very low mortality rates. Complete and early extraction was associated with significantly better clinical and economic outcome compared with no or late extraction. However, significant gaps in knowledge and poor recommendation compliance have been reported. Barriers to optimal management may include diagnostic delay, knowledge gaps, and limited access to expertise. A multipronged approach, including education of all stakeholders, a CIED-I alert system, and improving access to experts, could help bring paradigm shift in the treatment of this serious condition., Competing Interests: Funding Support and Author Disclosures This work was supported by Philips Image Guided Therapy Corporation. Dr Lakkireddy is a consultant for Philips and Abbott; and has received honoraria from Abbott, Medtronic, Boston Scientific, and Biosense Webster. Dr Sood is an employee of Philips Image Guided Therapy Corporation. Dr Wu is an employee of EVERSANA which has received funding from Philips Image Guided Therapy Corporation. Dr Rao has received honoraria from Medtronic, Boston Scientific, and Philips for educational activity and consultancy. Dr Sohail is a consultant for Medtronic Inc, Philips, and Aziyo Biologics, Inc. Dr Pokorney receives modest consultant/advisory board support from Boston Scientific, Medtronic, Philips, Bristol Myers Squibb, Pfizer, Sanofi, and Zoll; and has received modest research support from the Food and Drug Administration, Bristol Myers Squibb, Pfizer, Janssen, Gilead, Philips, Sanofi, and Boston Scientific. Dr Blomström-Lundqvist is a consultant for Boston Scientific, Medtronic, Philips, Bristol Myers Squibb, and Cathprint. Dr Piccini is a consultant for Abbott, Biotronik, Boston Scientific, Medtronic, and Philips; has received grants for clinical research from Abbott, American Heart Association, Boston Scientific, and Philips; and is supported by R01AG074185 from the National Institutes of Aging. Dr Granger has clinical research contracts from Boehringer Ingelheim, CeleCor, Bayer, Bristol Myers Squibb, the U.S. Food and Drug Administration, National Institutes of Health, Pfizer, Janssen, and Phillips; has received consulting/honoraria from AbbVie, Bayer, Bristol Myers Squibb, Boston Scientific, Boehringer Ingelheim, Hengrui, Janssen, Pfizer, Lilly, Medtronic, Merck, Novartis, NovoNordisk, and Reata; and has equity from tenac.io. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2023 The Authors. Published by Elsevier Inc. All rights reserved.)

Increasing maternal mortality and incidence of arrhythmias in pregnancy have been noted over the past 2 decades in the United States. Pregnancy is associated with a greater risk of arrhythmias, and patients with a history of arrhythmias are at significant risk of arrhythmia recurrence during pregnancy. The incidence of atrial fibrillation in pregnancy is rising. This review discusses the management of tachyarrhythmias and bradyarrhythmias in pregnancy, including management of cardiac arrest. Management of fetal arrhythmias are also reviewed. For patients without structural heart disease, β-blocker therapy, especially propranolol and metoprolol, and antiarrhythmic drugs, such as flecainide and sotalol, can be safely used to treat tachyarrhythmias. As a last resort, catheter ablation with minimal fluoroscopy can be performed. Device implantation can be safely performed with minimal fluoroscopy and under echocardiographic or ultrasound guidance in patients with clear indications for devices during pregnancy. Because of rising maternal mortality in the United States, which is partly driven by increasing maternal age and comorbidities, a multidisciplinary and/or integrative approach to arrhythmia management from the prepartum to the postpartum period is needed., Competing Interests: Funding Support and Author Disclosures Dr Vaseghi was supported by NIH R01 HL148190. Dr Mason has been a consultant for Medtronic and Boston Scientific. Dr Russo has received research funding from or has been a member of steering committees for Boston Scientific, Kestra, Medilynx, and Medtronic; and has been a consultant for Atricure, Biosense Webster, and Medtronic. Dr Volgman has been a MSD/Bayer Virtual Global Advisory Board Member; has been a member Bristol Myers Squibb Foundation of the Diverse Clinical Investigator Career Development Program; has been a member of the National Advisory Committee; and holds stock in Apple. Dr Vaseghi holds stock in Secures Inc., (Copyright © 2022 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Introduction: To evaluate the safety of uninterrupted versus interrupted direct oral anticoagulation (DOAC) for patients undergoing catheter ablation (CA) of atrial fibrillation (AF)., Methods: We conducted a systematic search of MEDLINE and EMBASE for randomized controlled trials (RCT) and observational studies comparing uninterrupted versus interrupted DOAC for patients undergoing CA of AF. Primary outcome was major bleeding. Secondary outcomes included minor bleeding, stroke or transient ischemic attack (TIA) or thromboembolism (TE), silent cerebral ischemic events, and cardiac tamponade. Meta-analysis was stratified by study design. Risk ratios (RR) with 95% confidence intervals were calculated using random effects model and Mantel-Haenszel method was used to pool RR., Results: A total of 13 studies (7 randomized, 6 observational) comprising 3595 patients were included. The RCT restricted analysis did not show any difference in terms of major bleeding (risk ratio [RR] = 0.79; [0.35-1.79]), minor bleeding (RR = 0.99 [0.68-1.43]), stroke or TIA or TE (RR = 0.80 [0.19-3.32]), silent cerebral ischemic events (RR = 0.64 [0.32-1.28]), and cardiac tamponade (RR = 0.61 [0.20-1.92]). Observational study restricted analysis showed a protective effect of uninterrupted DOAC on silent cerebral ischemic events (RR = 0.45 [0.31-0.67]) and no difference in other outcomes., Conclusions: There is no difference in bleeding and thromboembolic outcomes with uninterrupted versus interrupted DOAC for CA of AF and observational data suggests that uninterrupted DOACs are protective against silent cerebral ischemic lesions., (© 2021 Wiley Periodicals LLC.)

Atrial fibrillation and heart failure with reduced ejection fraction are increasing in prevalence worldwide. Atrial fibrillation can precipitate and can be a consequence of heart failure with reduced ejection fraction and cardiomyopathy. Atrial fibrillation and heart failure, when present together, are associated with worse outcomes. Together, these 2 conditions increase the risk of stroke, requiring oral anticoagulation in many or left atrial appendage closure in some. Medical management for rate and rhythm control of atrial fibrillation in heart failure remain hampered by variable success, intolerance, and adverse effects. In multiple randomized clinical trials in recent years, catheter ablation for atrial fibrillation in patients with heart failure and reduced ejection fraction has shown superiority in improving survival, quality of life, and ventricular function and reducing heart failure hospitalizations compared with antiarrhythmic drugs and rate control therapies. This has resulted in a paradigm shift in management toward nonpharmacological rhythm control of atrial fibrillation in heart failure with reduced ejection fraction. The primary objective of this American Heart Association scientific statement is to review the available evidence on the epidemiology and pathophysiology of atrial fibrillation in relation to heart failure and to provide guidance on the latest advances in pharmacological and nonpharmacological management of atrial fibrillation in patients with heart failure and reduced ejection fraction. The writing committee's consensus on the implications for clinical practice, gaps in knowledge, and directions for future research are highlighted.

Objectives: The aim of this analysis was to evaluate the predictors associated with increased risk of permanent pacemaker implantation (PPMI) following transcatheter aortic valve replacement (TAVR)., Background: While TAVR has evolved as the standard of care for patients with severe aortic stenosis, conduction abnormalities leading to the need for PPMI is one of the most common postprocedural complications., Methods: A systematic literature search was performed to identify relevant trials from inception to May 2020. Summary effects were calculated using a DerSimonian and Laird random-effects model as odds ratio with 95% confidence intervals for all the clinical endpoints., Results: Thirty-seven observational studies with 71 455 patients were identified. The incidence of PPMI following TAVR was 22%. Risk was greater in men and increased with age. Patients with diabetes mellitus, presence of right bundle branch block, baseline atrioventricular conduction block, and left anterior fascicular block were noted to be at higher risk. Other significant predictors include the presence of high calcium volume in the area below the left coronary cusp and noncoronary cusp, use of self-expandable valve over balloon-expandable valve, depth of implant, valve size/annulus size, predilatation balloon valvuloplasty, and postimplant balloon dilation., Conclusion: Fourteen factors were found to be associated with increased risk of PPMI after TAVR, suggesting early identification of high-risk populations and targeting modifiable risk factors may aid in reducing the need for this post TAVR PPMI., (© 2021 Wiley Periodicals LLC.)

Background: Arrhythmia-induced cardiomyopathy (AIC) is characterized by improvement in left ventricular ejection fraction (LVEF) following arrhythmia treatment. Predictors of recovery in LVEF are not well understood., Objective: We evaluated predictors of AIC recovery in a large multicenter cohort., Methods: In total, 243 patients (age 65 ± 11, 73% male) with AIC caused by atrial fibrillation (49%), atrial tachycardia (20%), and premature ventricular contractions (PVCs; 31%) were treated and included. LVEF was assessed before and after treatment. Patients were stratified by arrhythmia duration (known [KN, n = 132] vs. unknown [UKN, n = 111]), arrhythmia type, LVEF, and presence of structural heart disease (SHD)., Results: Arrhythmia treatment was rhythm control in 95%. Median arrhythmia duration in the KN group was 47 months (25-75th percentile, 24-80 months). Post treatment LVEF was higher in KN group (55.9 ± 7 vs. 46.2 ± 12%; p < .0001) but the degree of LVEF improvement was similar (21.2 ± 9 vs. 19.4 ± 11; p = .16). Comparing highest quartile (longest arrhythmia duration) versus the rest of the KN group, the extent of LVEF improvement was similar (21.5 ± 8 vs. 21 ± 9%; p = .1). Patients in lowest index LVEF quartile (n = 74) had more PVC-induced AIC, greater EF improvement after treatment (24 ± 17 vs. 19 ± 7%; p < .0001) but lower post treatment EF (45 ± 14 vs. 54 ± 8%; p < .0001) versus other patients. Patients with SHD had lower index EF (28 ± 8 vs. 34 ± 8%; p < .0001) and lower final EF (47 ± 12 vs. 56 ± 7; p ≪ .0001). In multivariate regression, low index LVEF predicted myocardial recovery (odds ratio, 11.4; p < .005)., Conclusions: In this AIC cohort, LVEF improved regardless of arrhythmia duration or type but those with PVCs had lower index LVEF and had less recovery. Low index LVEF predicted LVEF recovery following arrhythmia treatment., (© 2021 Wiley Periodicals LLC.)

Patients with tetralogy of Fallot are at risk for ventricular arrhythmias and sudden cardiac death. These abnormalities are associated with pulmonary regurgitation, right ventricular enlargement, and a substrate of discrete, slowly-conducting isthmuses. Although these arrhythmic events are rare, their prediction is challenging. This review will address contemporary risk assessment and prevention strategies. Numerous variables have been proposed to predict who would benefit from an implantable cardioverter-defibrillator. Current risk stratification models combine independently associated factors into risk scores. Cardiac magnetic resonance imaging, QRS fragmentation assessment, and electrophysiology testing in selected patients may refine some of these models. Interaction between right and left ventricular function is emerging as a critical factor in our understanding of disease progression and risk assessment. Multicenter studies evaluating risk factors and risk mitigating strategies such as pulmonary valve replacement, ablative strategies, and use of implantable cardiac-defibrillators are needed moving forward., Competing Interests: Funding Support and Author Disclosures Dr. Khairy is supported by the André Chagnon Research Chair in Electrophysiology and Congenital Heart Disease. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2021 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background: Cardiovascular and arrhythmic events have been reported in hospitalized COVID-19 patients. However, arrhythmia manifestations and treatment strategies used in these patients have not been well-described. We sought to better understand the cardiac arrhythmic manifestations and treatment strategies in hospitalized COVID-19 patients through a worldwide cross-sectional survey., Methods: The Heart Rhythm Society (HRS) sent an online survey (via SurveyMonkey) to electrophysiology (EP) professionals (physicians, scientists, and allied professionals) across the globe. The survey was active from March 27 to April 13, 2020., Results: A total of 1197 respondents completed the survey with 50% of respondents from outside the USA, representing 76 countries and 6 continents. Of respondents, 905 (76%) reported having COVID-19-positive patients in their hospital. Atrial fibrillation was the most commonly reported tachyarrhythmia whereas severe sinus bradycardia and complete heart block were the most common bradyarrhythmias. Ventricular tachycardia/ventricular fibrillation arrest and pulseless electrical activity were reported by 4.8% and 5.6% of respondents, respectively. There were 140 of 631 (22.2%) respondents who reported using anticoagulation therapy in all COVID-19-positive patients who did not otherwise have an indication. One hundred fifty-five of 498 (31%) reported regular use of hydroxychloroquine/chloroquine (HCQ) + azithromycin (AZM); concomitant use of AZM was more common in the USA. Sixty of 489 respondents (12.3%) reported having to discontinue therapy with HCQ + AZM due to significant QTc prolongation and 20 (4.1%) reported cases of Torsade de Pointes in patients on HCQ/chloroquine and AZM. Amiodarone was the most common antiarrhythmic drug used for ventricular arrhythmia management., Conclusions: In this global survey of > 1100 EP professionals regarding hospitalized COVID-19 patients, a variety of arrhythmic manifestations were observed, ranging from benign to potentially life-threatening. Observed adverse events related to use of HCQ + AZM included prolonged QTc requiring drug discontinuation as well as Torsade de Pointes. Large prospective studies to better define arrhythmic manifestations as well as the safety of treatment strategies in COVID-19 patients are warranted.

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., (Copyright © 2020 Heart Rhythm Society. Published by Elsevier Inc. All rights reserved.)

Coronavirus disease 2019 (COVID-19) has presented substantial challenges to patient care and impacted health care delivery, including cardiac electrophysiology practice throughout the globe. Based upon the undetermined course and regional variability of the pandemic, there is uncertainty as to how and when to resume and deliver electrophysiology services for arrhythmia patients. This joint document from representatives of the Heart Rhythm Society, American Heart Association, and American College of Cardiology seeks to provide guidance for clinicians and institutions reestablishing safe electrophysiological care. To achieve this aim, we address regional and local COVID-19 disease status, the role of viral screening and serologic testing, return-to-work considerations for exposed or infected health care workers, risk stratification and management strategies based on COVID-19 disease burden, institutional preparedness for resumption of elective procedures, patient preparation and communication, prioritization of procedures, and development of outpatient and periprocedural care pathways., (Copyright © 2020 The Heart Rhythm Society, the American Heart Association, Inc., and the American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Coronavirus disease 2019 (COVID-19) is a global pandemic that is wreaking havoc on the health and economy of much of human civilization. Electrophysiologists have been impacted personally and professionally by this global catastrophe. In this joint article from representatives of the Heart Rhythm Society, the American College of Cardiology, and the American Heart Association, we identify the potential risks of exposure to patients, allied healthcare staff, industry representatives, and hospital administrators. We also describe the impact of COVID-19 on cardiac arrhythmias and methods of triage based on acuity and patient comorbidities. We provide guidance for managing invasive and noninvasive electrophysiology procedures, clinic visits, and cardiac device interrogations. In addition, we discuss resource conservation and the role of telemedicine in remote patient care along with management strategies for affected patients., (Copyright © 2020. Published by Elsevier Inc.)

Coronavirus disease 2019 (COVID-19) has presented substantial challenges to patient care and impacted healthcare delivery, including cardiac electrophysiology practice throughout the globe. Based upon the undetermined course and regional variability of the pandemic, there is uncertainty as to how and when to resume and deliver electrophysiology services for patients with arrhythmia. This joint document from representatives of the Heart Rhythm Society, American Heart Association, and American College of Cardiology seeks to provide guidance for clinicians and institutions reestablishing safe electrophysiological care. To achieve this aim, we address regional and local COVID-19 disease status, the role of viral screening and serological testing, return-to-work considerations for exposed or infected health care workers, risk stratification and management strategies based on COVID-19 disease burden, institutional preparedness for resumption of elective procedures, patient preparation and communication, prioritization of procedures, and development of outpatient and periprocedural care pathways.

Atrial fibrillation (AF) is an increasingly prevalent arrhythmia; its pathophysiology and progression are well studied. Stroke and bleeding risk models have been created and validated. Decision tools for stroke prophylaxis are evolving, with better options at hand. Utilization of various diagnostic tools offer insight into AF burden and thromboembolic risk. Rate control, rhythm control, and stroke prophylaxis are the cornerstones of AF therapy. Although antiarrhythmic drugs are useful, AF ablation has become a primary therapeutic strategy. Pulmonary vein isolation is the cornerstone of AF ablation, and methods to improve ablation safety and efficacy continue to progress. Ablation of nonpulmonary vein sites is increasingly being recognized as an important strategy for treating nonparoxysmal AF. Several new ablation techniques and technologies and stroke prophylaxis are being explored. This is a contemporary review on the prevalence, pathophysiology, risk prediction, prophylaxis, treatment options, new insights for optimizing treatment outcomes, and emerging concepts of AF., (Copyright © 2020. Published by Elsevier Inc.)

Objectives: This study aimed to investigate the feasibility and safety of left atrial appendage occlusion (LAAO) procedures in patients with persistent left atrial appendage (LAA) thrombus., Background: The left atrial appendage (LAA) is the most common site of thrombus formation in patients with nonvalvular atrial fibrillation (AF). Oral anticoagulation (OAC) is used to prevent and treat AF-related thrombus. However, a significant proportion of patients may not be eligible for long-term OAC therapy. In many cases, OAC may fail to resolve the thrombus. Left atrial appendage occlusion (LAAO) may be a potential option in such cases. Major LAAO studies have excluded patients with LAA thrombus, and it is not known whether LAAO procedures in the presence of LAA thrombus is feasible and safe., Methods: This was a systematic review of patient-level data of all published cases of LAAO in the presence of LAA thrombus., Results: There was a total of 58 patients included in the study. Most of the patients had a distally located thrombus in the LAA. All cases underwent successful implantation of LAAO devices with some procedural modifications. Amulet was the most commonly used device (50%). A cerebral protection device was used in 17 (29%) patients, and procedural transesophageal echocardiography was used in most of the cases. One stroke (1.7%) and 2 (3.4%) device-related thromboses were noted during the mean follow-up of 3.4 ± 7 months., Conclusions: Percutaneous LAAO procedures appear to be feasible in patients with a distally located persistent LAA thrombus when performed by experienced operators with some technical modifications. Further studies are required to determine the long-term safety and efficacy of this approach., (Copyright © 2020 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background: Percutaneous left atrial appendage closure (pLAAC) emerged as an option for stroke prevention in patients with atrial fibrillation ineligible for long-term anticoagulation. Real-world data on pLAAC's in-hospital and 30-day readmission measures are limited., Objective: We sought to report the nationwide incidence of the above outcomes using 2016 claims data., Methods: We used the National Inpatient Sample for in-hospital outcomes and Nationwide Readmissions Database for readmissions. We identified hospitalizations with a primary diagnosis of atrial fibrillation and pLAAC procedure by using International Classification of Diseases, Tenth Revision codes and compared the outcomes mentioned above between the endocardial and epicardial cohorts. Statistical analyses were performed using R 3.3.2., Results: Among 5480 pLAAC procedures (endocardial: 5145; epicardial: 335), the in-hospital mortality was 0.3%. Endocardial left atrial appendage closure (LAAC) had lower complications (8.5% vs 25.4%; P < .001) and shorter length of stay median [interquartile range] 1 [1-1] day vs 2 [1-3] days; P < .001) but higher hospitalization cost (24.13 [18.45-30.17] × 1000 dollars vs 21.21 [14.03-27.86] × 1000 dollars; P = .016). The most common complications include pericardial (endocardial vs epicardial: 3% vs 10.4%; P < .001) and renal failure (1.4% vs 6.0%; P = .004). Epicardial LAAC had higher 30-day unplanned readmissions (19.5% vs 8.3%; P = .001), with the most common reason being pericarditis and/or effusion (33.9%)., Conclusion: Endocardial LAAC had lower complications and 30-day readmissions but higher hospitalization cost. Although epicardial LAAC showed higher complications, given recent improvements in its technique, and postprocedural care demonstrated a significant reduction in pericardial complications, more contemporary data comparing these outcomes are needed., (Copyright © 2019 Heart Rhythm Society. Published by Elsevier Inc. All rights reserved.)

Background: Catheter ablation is proven to be an effective strategy for drug refractory ventricular tachycardia (VT) in ischemic cardiomyopathy. However, the appropriate timing of VT ablation and identifying the group of patients that may receive the greatest benefit remains uncertain. There is limited data on the effect on prophylactic catheter ablation (PCA) in the prevention of implantable cardioverter defibrillator (ICD) therapy, electrical storm, and mortality., Methods: We performed a comprehensive literature search through November 1, 2017, for all eligible studies comparing PCA + ICD versus ICD only in eligible patients with ischemic cardiomyopathy. Clinical outcomes included all ICD therapies including ICD shocks and electrical storm. Additional outcomes included all-cause mortality, cardiovascular mortality, and complications., Results: Three randomized controlled trials (RCTs) (N = 346) met inclusion criteria. PCA was associated with a significantly lower ICD therapies (OR 0.49; CI 0.28 to 0.87; p = 0.01) including ICD shocks [OR 0.38; CI 0.22 to 0.64; p = 0.0003) and electrical storm (OR 0.55; CI 0.30 to 1.01; p = 0.05) when compared with ICD only. There was no significant difference in all-cause mortality (OR 0.77; CI 0.41 to 1.46; p = 0.42), cardiovascular mortality (OR 0.49; CI 0.16 to 1.50; p = 0.21), and major adverse events (OR 1.45; CI 0.52 to 4.01; p = 0.47) between two groups., Conclusion: These results suggest prophylactic catheter ablation decreases ICD therapies, including shocks and electrical storm with no improvement in overall mortality. There is a need for future carefully designed randomized clinical trials.

Background: Percutaneous left atrial appendage exclusion (LAAE) has evolved as an alternative strategy for stroke prevention in atrial fibrillation (AF). Recent observational data have suggested that epicardial LAAE can have substantial impact on arrhythmia burden and hemodynamic profile., Objectives: The authors aimed to study the impact of epicardial versus endocardial LAAE on systemic blood pressure in hypertensive AF patients., Methods: This was a prospective, nonrandomized study comparing 247 patients who underwent epicardial LAAE with 124 patients with endocardial exclusion. Clinical outcomes were measured at 3 months and 1 year. Primary outcome was improvement in systolic blood pressure (SBP) between both groups compared with baseline. Secondary outcome included changes in diastolic pressures (DBP), serum electrolytes, and creatinine., Results: There was no significant difference in baseline SBP between epicardial and endocardial groups. SBP was significantly lower in the epicardial group both at 3 months (122 ± 11.8 mm Hg vs. 129.7 ± 8.2 mm Hg; p < 0.001) and 1 year (123 ± 11.6 mm Hg vs. 132.2 ± 8.8 mm Hg; p < 0.001) compared with the endocardial group. An adjusted multivariate linear mixed effects model demonstrated that epicardial LAAE significantly decreased SBP by 7.4 mm Hg at 3 months and by 8.9 mm Hg at 1 year (p < 0.0001). There was a trend toward lower DBP with epicardial LAAE at 3 months by 1.3 mm Hg (p = 0.2) and at 1 year by 1.8 mm Hg (p = 0.09). There was no significant difference in serum electrolytes and creatinine between both groups., Conclusions: In hypertensive AF patients, epicardial LAAE significantly decreases SBP both at 3 and 12 months compared with endocardial exclusion., (Copyright © 2018 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Objectives: This study sought to characterize ventricular tachycardia (VT) ablation outcomes across nonischemic cardiomyopathy (NICM) etiologies and adjust these outcomes by patient-related comorbidities that could explain differences in arrhythmia recurrence rates., Background: Outcomes of catheter ablation of VT in patients with NICM could be related to etiology of NICM., Methods: Data from 2,075 patients with structural heart disease referred for catheter ablation of VT from 12 international centers was retrospectively analyzed. Patient characteristics and outcomes were noted for the 6 most common NICM etiologies. Multivariable Cox proportional hazards modeling was used to adjust for potential confounders., Results: Of 780 NICM patients (57 ± 14 years of age, 18% women, left ventricular ejection fraction 37 ± 13%), underlying prevalence was 66% for dilated idiopathic cardiomyopathy (DICM), 13% for arrhythmogenic right ventricular cardiomyopathy (ARVC), 6% for valvular cardiomyopathy, 6% for myocarditis, 4% for hypertrophic cardiomyopathy, and 3% for sarcoidosis. One-year freedom from VT was 69%, and freedom from VT, heart transplantation, and death was 62%. On unadjusted competing risk analysis, VT ablation in ARVC demonstrated superior VT-free survival (82%) versus DICM (p ≤ 0.01). Valvular cardiomyopathy had the poorest unadjusted VT-free survival, at 47% (p < 0.01). After adjusting for comorbidities, including age, heart failure severity, ejection fraction, prior ablation, and antiarrhythmic medication use, myocarditis, ARVC, and DICM demonstrated similar outcomes, whereas hypertrophic cardiomyopathy, valvular cardiomyopathy, and sarcoidosis had the highest risk of VT recurrence., Conclusions: Catheter ablation of VT in NICM is effective. Etiology of NICM is a significant predictor of outcomes, with ARVC, myocarditis, and DICM having similar but superior outcomes to hypertrophic cardiomyopathy, valvular cardiomyopathy, and sarcoidosis, after adjusting for potential covariates., (Copyright © 2018 American College of Cardiology Foundation. All rights reserved.)

Background: There is limited data regarding effect of prolonged radiation exposure during electrophysiological (EP) procedures on direct DNA damage. Comet test has shown to assess DNA damage following radiation exposure., Methods: We performed a single-center prospective observational study assessing direct DNA damage using the quantitative comet assay in patients undergoing cardiac resynchronization (CRT) and atrial fibrillation (AF) catheter ablation procedures. Venous comet assay was performed pre, immediately post procedure and at 3-month duration in twenty-two (N=22) patients who underwent catheter ablation for symptomatic AF and fourteen (N=14) patients who underwent CRT implantation., Results: The median [interquartile range (IQR)] fluoroscopy time, radiation dose and dose area product (DAP) were 34.3 (27.97 - 45.48) minutes, 853.07 (611.36 - 1334.76) mGy and 16,994.10 (9,023.65 - 58,845.00) UGym2 in the ablation group and 30.05 (18.75 - 37.33) minutes, 345.00 (165.09 - 924.79) mGy and 11,837.20 [7182.67 - 35567.75] UGym2 in the CRT group. When compared with pre-procedure, there was a statistically significant increase in median (IQR) DNA migration on comet assay in the ablation group immediately post procedure [+6.55 µm (0.78, 10.25, p=0.02)] that subsequently decreased at 3 months [-1.00 µm (-2.20, 0.78), p=0.03] but not in the CRT group., Conclusion: There was a significant increase in DNA damage as detected by comet assay immediately post procedure that normalized at 3 months in patients undergoing AF ablation. Further large prospective studies are warranted to evaluate the impact of this prolonged radiation exposure and DNA damage on long-term follow up.

Background: There is no nonparenteral medication for the rapid termination of paroxysmal supraventricular tachycardia., Objectives: The purpose of this study was to assess the efficacy and safety of etripamil nasal spray, a short-acting calcium-channel blocker, for the rapid termination of paroxysmal supraventricular tachycardia (SVT)., Methods: This phase 2 study was performed during electrophysiological testing in patients with previously documented SVT who were induced into SVT prior to undergoing a catheter ablation. Patients in sustained SVT for 5 min received either placebo or 1 of 4 doses of active compound. The primary endpoint was the SVT conversion rate within 15 min of study drug administration. Secondary endpoints included time to conversion and adverse events., Results: One hundred four patients were dosed. Conversion rates from SVT to sinus rhythm were between 65% and 95% in the etripamil nasal spray groups and 35% in the placebo group; the differences were statistically significant (Pearson chi-square test) in the 3 highest active compound dose groups versus placebo. In patients who converted, the median time to conversion with etripamil was <3 min. Adverse events were mostly related to the intranasal route of administration or local irritation. Reductions in blood pressure occurred predominantly in the highest etripamil dose., Conclusions: Etripamil nasal spray rapidly terminated induced SVT with a high conversion rate. The safety and efficacy results of this study provide guidance for etripamil dose selection for future studies involving self-administration of this new intranasal calcium-channel blocker in a real-world setting for the termination of SVT. (Efficacy and Safety of Intranasal MSP-2017 [Etripamil] for the Conversion of PSVT to Sinus Rhythm [NODE-1]; NCT02296190)., (Copyright © 2018 Milestone Pharmaceuticals Inc. Published by Elsevier Inc. All rights reserved.)

Left atrial appendage (LAA) closure has evolved as an effective strategy for stroke prevention in patients with atrial fibrillation who are considered suitable for oral anticoagulation. There is strong evidence based on randomized clinical trials with 1 percutaneous device, as well as a large registry experience with several devices, regarding the safety and efficacy of this strategy. In addition, there is encouraging data regarding the effect of epicardial LAA closure on decreasing arrhythmia burden and improvements in systemic homeostasis by neurohormonal modulation. However, there are several unresolved issues regarding optimal patient selection, device selection, management of periprocedural complications including device-related thrombus, residual leaks, and pericarditis. In this review, we summarize the rationale, evidence, optimal patient selection, and common challenges encountered with mechanical LAA exclusion., (Copyright © 2018 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background: The safety of perioperative anticoagulation (AC) and antiplatelet (AP) therapy with subcutaneous implantable cardioverter-defibrillator (S-ICD) implantation is unknown. The purpose of this study was to identify the risk factors associated with hematoma complicating S-ICD implantation., Methods: Records were retrospectively reviewed from 200 consecutive patients undergoing S-ICD implantation at two academic medical centers. A hematoma was defined as a device site blood accumulation requiring surgical evacuation, extended hospital stay, or transfusion., Results: Among 200 patients undergoing S-ICD implantation (age 49 ± 17 years, 67% men), 10 patients (5%) had a hematoma, which required evacuation in six patients (3%). Warfarin was bridged or uninterrupted in 12 and 13 patients, respectively (6% and 6.5%). Four of 12 patients with warfarin and bridging AC (33%) and two of 13 patients with uninterrupted warfarin (15%) developed a hematoma. Neither of the two patients with uninterrupted DOAC had a hematoma. No patients on interrupted AC without bridging (n = 26, 13 with warfarin, 13 with DOAC) developed a hematoma. A hematoma was also more likely with the use of clopidogrel (n = 4/10 vs 10/190, 40% vs 5.3%, P < 0.0001) in combination with aspirin in 12/14 patients. Any bridging AC (odds ratio [OR] 10.3, 1.8-60.8, P = 0.01), clopidogrel (OR 10.0, 1.7-57.7, P = 0.01), and uninterrupted warfarin without bridging (OR 11.1, 1.7-74.3, P = 0.013) were independently associated with hematoma formation., Conclusion: AC and/or AP therapy with clopidogrel appears to increase the risk for hematoma following S-ICD implantation. Interruption of AC without bridging should be considered when it is an acceptable risk to hold AC., (© 2018 Wiley Periodicals, Inc.)

Medical devices have been targets of hacking for over a decade, and this cybersecurity issue has affected many types of medical devices. Lately, the potential for hacking of cardiac devices (pacemakers and defibrillators) claimed the attention of the media, patients, and health care providers. This is a burgeoning problem that our newly electronically connected world faces. In this paper from the Electrophysiology Section Council, we briefly discuss various aspects of this relatively new threat in light of recent incidents involving the potential for hacking of cardiac devices. We explore the possible risks for the patients and the effect of device reconfiguration in an attempt to thwart cybersecurity threats. We provide an outline of what can be done to improve cybersecurity from the standpoint of the manufacturer, government, professional societies, physician, and patient., (Copyright © 2018 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background: Percutaneous left atrial appendage closure (LAAC) is a viable option for AF patients who are unable to tolerate long-term oral anticoagulation (OAC)., Objective: We sought to assess the safety of two commonly used percutaneous devices for LAA closure in the United States by analysis of surveillance data from the FDA Manufacturer and User Facility Device Experience (MAUDE) database., Methods: The MAUDE database was queried between May 1, 2006 and May 1, 2016 for LARIAT ® (SentreHEART Inc., Redwood City, CA, USA) and WATCHMAN™ (Boston Scientific Corp., Marlborough, MA, USA) devices. Among 622 retrieved medical device reports, 356 unique and relevant reports were analyzed. The cumulative incidence of safety events was calculated over the study period and compared between the two devices., Results: LAAC was performed with LARIAT in 4,889 cases. WATCHMAN was implanted in 2,027 patients prior to FDA approval in March 2015 and 3,822 patients postapproval. The composite outcome of stroke/TIA, pericardiocentesis, cardiac surgery, and death occurred more frequently with WATCHMAN (cumulative incidence, 1.93% vs. 1.15%; P = 0.001). The same phenomenon was observed when comparing the WATCHMAN pre- and postapproval experiences for the composite outcome, as well as device embolization, cardiac surgery, and myocardial infarction., Conclusions: MAUDE-reported data show that postapproval, new technology adoption is fraught with increased complications. Improved collaboration between operators, device manufacturers, and regulators can better serve patients through increased transparency and practical postmarket training and monitoring mechanisms., (© 2017 Wiley Periodicals, Inc.)

With a steadily increasing prevalence, atrial fibrillation (AF) is the most common sustained cardiac arrhythmia worldwide and an independent risk factor for stroke caused by thromboembolic events. The left atrial appendage (LAA) is the primary source of thromboemboli in patients with nonvalvular AF who have a stroke. Novel strategies (such as mechanical and nonpharmacological intervention) targeting the LAA in patients with AF for stroke prevention have become a major focus during the past decade. Some devices for percutaneous LAA occlusion are supported by robust clinical data obtained from randomized trials or large registries, and are a valid alternative to pharmacological stroke prevention. However, the incidence of periprocedural complications and the presence of device-related thrombi or residual LAA leaks, whose long-term clinical implications are still unknown, are limiting factors in wider acceptability of these techniques. In this Review, we discuss the available techniques for LAA occlusion in patients with nonvalvular AF at high risk of stroke. We describe the pharmacological and mechanical approaches to LAA occlusion, and provide the current clinical evidence for various strategies. We particularly focus on the current management of the LAA, and discuss the challenges and future implications of the available approaches to LAA occlusion.

Background: Implantation of cardiac implanted electronic device (CIED) has surged lately. This resulted in a rise in cardiac device-related infections (CDI) and inevitably, lead extractions. We examined the recent national trend in the incidence of CIED infections and lead extractions in hospitalized patients and associated mortality., Methods: Using the Nationwide Inpatient Sample for the years 2003-2011 we identified patients diagnosed with a CDI-associated infection as determined by discharge ICD-9 diagnostic codes. We examined the trend of device-related infections overall and in different subgroups. We studied mortality associated with device infections, lead extractions, associated costs, and length of stay., Results: There is a significant increase in the number of hospitalizations due to CDI from 5,308 in the year 2003 to 9,948 in 2011. Males (68%), Caucasians (77%), and age group 65-84 years (56.4%) accounted for majority of CDI. The mortality associated with CDI was 4.5 %, and was worse in higher age groups (2.5% in 18-44 years compared to 5.3% in 85+ years, P < 0.001). Average length of stay was unchanged over the years remaining at 13.6 days; however, mean hospitalization charges increased from $91,348 in 2003 to $173,211 in 2011 (P < 0.001). Among all lead extraction procedures, the percentage of patients undergoing lead extraction secondary to CDI also increased from 2003 (59.1%) to 2011 (76.7%), P-value < 0.001., Conclusions: Healthcare burden associated with CDI infections and associated lead extractions has significantly increased in the recent years. Despite an increase in cost associated with CIED infections, mortality remains the same, and is higher in older patients., (© 2017 Wiley Periodicals, Inc.)

Purpose of Review: The authors reviewed the seminal and more recent literature surrounding the major modalities for percutaneous left atrial appendage closure used in contemporary practice, with particular emphasis on safety and efficacy, technical challenges, and future developments., Recent Findings: Along with the continued practice of surgical left atrial appendage closure, which has evolved substantially with the advent of clipping techniques, a number of percutaneous methods have been developed to close the left atrial appendage with endocardial, epicardial, and hybrid approaches. The last 18 months has seen the Food and Drug Administration approval of the WATCHMAN device for stroke prevention in the United States, the initiation of a randomized controlled trial to further examine the LARIAT device, and an increasing body of literature surrounding use of the AMPLATZER Amulet in Europe., Summary: Left atrial appendage closure is a promising alternative to systemic anticoagulation for stroke prevention in appropriate atrial fibrillation patients. The wealth of available data for the various modalities sheds light on the strengths and limitations of each, postprocedural complications and their management, and new areas for exploration. With a plethora of new devices on the horizon, it is a very exciting time in the field of 'appendage-ology' as we pursue new avenues to optimize care for atrial fibrillation patients.

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., (Copyright © 2016 Heart Rhythm Society. Published by Elsevier Inc. All rights reserved.)

Left atrial appendage closure (LAAC) is a promising site-directed therapy for stroke prevention in patients with non-valvular atrial fibrillation (AF) who are ineligible or contraindicated for long-term oral anticoagulation. A variety of LAAC modalities are available, including percutaneous endocardial occluder devices such as WATCHMAN TM (Boston Scientific Corp., Marlborough, MA, USA), and an ever-increasing body of evidence is helping to define the optimal use of each technique. Similarly increased experience with LAAC has revealed challenges such as device-related thrombi and peri-device leaks for which the long-term significance and appropriate management are areas of active investigation. We review the evolution and long-term outcomes with the WATCHMAN TM device with particular emphasis on the nuances of its use and its role in the broader landscape of appendageology., Competing Interests: The authors have no conflicts of interest to declare.