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Background: Selection of an appropriate antithrombotic regimen in patients requiring oral anticoagulation (OAC) undergoing percutaneous coronary intervention (PCI) still remains a challenge. An ideal 9-2regimen should balance the risk of bleeding against ischemic benefit., Methods: A comprehensive literature search for studies comparing triple antithrombotic therapy (TAT) vs double antithrombotic therapy (DAT) in patients requiring OAC undergoing PCI was performed in clinicalTrials.gov, PubMed, Web of Science, EBSCO Services, Cochrane Central Register of Controlled Trials, Google Scholar, and various scientific conference sessions from inception to May 1st, 2019. A meta-analysis was performed using random-effects model to calculate risk ratio (RR) and 95% confidence interval (CI)., Results: Fifteen studies were eligible and included 13 967 patients, of which 7349 received TAT and 6618 received DAT. Compared with DAT, TAT was associated with lower risk of myocardial infarction (RR, 0.82; 95%CI, 0.69-0.98; P = .03) and stent thrombosis (RR, 0.66; 95%CI, 0.46-0.96; P = .03). There was no difference in risk of trial defined major adverse cardiac events, all-cause mortality, and stroke between two groups. Compared with DAT, TAT was associated with higher risk of trial defined major bleeding (RR, 1.67; 95%CI, 1.38-2.01; P < .00001), including thrombolysis in myocardial infarction major bleeding (RR, 1.81; 95%CI, 1.47-2.24; P < .00001) but no significant difference in risk of intracranial bleeding., Conclusion: In patients requiring OAC undergoing PCI, TAT was associated with a lower risk of myocardial infarction but with a significantly higher risk of major bleeding when compared with DAT., (© 2019 Wiley Periodicals, Inc.)

Objectives: The purpose of this study was to evaluate the differences in transient thermal response (TTR) among various types of commercial esophageal temperature probes (ETPs) in the United States in an experimental model., Background: There is little information regarding the variation in TTR among various commercial ETPs that are approved for atrial fibrillation ablation., Methods: We compared various thermodynamic characteristics including, mean thermal time constant (τ), time to rise 1°C (T 1°C ), time to peak temperature (T peak ), and decay time among 22 different ETPs. Each probe was submerged in a constant-temperature water bath maintained at 37 ± 0.5°C and then quickly (<0.5 s) submerged into another water bath at 45 ± 0.5°C. The experiments were repeated 3 times with each probe. TTR properties were compared on the basis of probe size, design, and number of sensors., Results: The τ was significantly higher with the larger 24- and 18-F ETPs compared with the smaller 9-F ETPs. Compared with the 18-F probe, T 1°C (11.9 s vs. 5 s), T peak (40.3 s vs. 14.4 s), and T decay (92.4 s vs. 32.4 s) was shorter with the 9-F ETPs. Solid-shaft ETPs had shorter τ (8.6 s vs. 20.5 s), T 1°C (4.4 s vs. 10.1 s) and T peak (13.5 s vs. 32.5 s) compared with acoustascopes. Multisensor ETPs had shorter τs (3.9 s vs. 9.1 s), T 1°C (2.3 s vs. 5 s), and T peak (6.2 s vs. 14.4 s) compared with single-sensor ETPs., Conclusions: There is a significant variation in TTR among the various commercially available ETPs. The use of certain ETPs might result in underestimation of luminal esophageal temperature, which can potentially lead to adverse events., (Copyright © 2019 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background: There is a lack of compelling data regarding the benefit of percutaneous ventricular assist devices (PVAD) in patients undergoing ventricular tachycardia (VT) ablation. The study aims to conduct a meta-analysis comparing the safety and efficacy of PVAD versus no-PVAD (N-PVAD) during VT ablation., Methods: Studies meeting criteria were systematically reviewed. Baseline characteristics and clinical outcomes were extracted and analyzed. A meta-analysis was performed using random-effects model to calculate risk ratio (RR) and mean difference (MD) with 95% confidence interval (CI)., Results: The meta-analysis included five retrospective, observational studies consisting of 2026 patients (PVAD group-284 patients versus N-PVAD group-1742 patients). The PVAD group was sicker with significantly higher VT storm, lower LVEF and greater proportion of NYHA class ≥ III than N-PVAD (p < 0.050). The acute procedural success [RR 0.95, 95% CI, (0.89-1.00), p = 0.070], VT recurrence [RR 0.94, 95% CI, (0.66-1.34), p = 0.740] and mortality [RR 1.28, 95% CI, (0.43-3.83), p = 0.660] were similar on follow-up between PVAD versus N-PVAD. PVAD group also had significantly higher complications [RR 1.83, 95% CI (1.21-2.76), p = 0.004] and longer fluoroscopy [MD + 7.31 min, 95% CI (0.91-13.71), p = 0.030] and procedure time [MD + 71.41 min, 95% CI (31.67-111.14), p < 0.001] than N-PVAD., Conclusion: Patients receiving PVAD support during VT ablation were sicker with no significant difference in acute procedural success, VT recurrence, and mortality compared with N-PVAD. PVAD support was also associated with higher complications and longer fluoroscopy and procedure time. A prospective randomized controlled trial will identify if using PVAD support in unstable patients undergoing VT ablation will impact clinical outcomes.

Background: Atrial arrhythmias (AA), including atrial fibrillation (AF), have been reported in patients after cavotricuspid isthmus (CTI) ablation for typical atrial flutter (AFL). Several studies have examined the effect of performing concomitant pulmonary vein isolation (PVI) with CTI on recurrent AA. These studies were analyzed to determine the overall effect of this approach on recurrent AA., Methods: PubMed and Google Scholar were searched for randomized trials comparing the incidence of AA after CTI versus CTI + PVI until June 2018. Only patients without prior history of AF were included in the recurrent AA analysis. All patients were included in the analyses of other clinical outcomes., Results: Four randomized control trials were included in the meta-analysis. In the recurrent AA analysis, a total of 314 patients were randomized in the studies (n = 158 CTI, n = 156 CTI + PVI). Freedom from AA at 1 year was significantly higher in the CTI + PVI group versus CTI alone (odds ratio [OR] 0.25 [0.14, 0.44] 95% confidence interval [CI], P < 0.00001). A total of 550 patients (n = 336 CTI, n = 214 CTI + PVI) were included in analyses for procedure time, fluoroscopy time, and complications rates. Procedure time and fluoroscopy time were significantly longer in the CTI + PVI group (mean difference [MD]: 103.31 min [94.40, 112.23] 95% CI, P < 0.00001) and (MD: 16.47 min [14.89, 18.05] 95% CI, P < 0.00001), respectively. Total complications were statistically similar between groups., Conclusion: This meta-analysis shows addition of a prophylactic PVI during CTI ablation significantly reduces recurrent AA at 1 year without significantly increasing major complications., (© 2019 Wiley Periodicals, Inc.)

Background: Currently, there is limited data regarding the impact of adjunctive renal sympathetic denervation (RSDN) with pulmonary vein isolation (PVI) in hypertensive patients with atrial fibrillation (AF)., Methods: A comprehensive literature search for studies comparing RSDN + PVI vs PVI alone for AF and history of hypertension until 1 January 2019 was performed. The results were expressed as risk ratio (RR) for the categorical variables and mean difference (MD) for the continuous variables with 95% confidence intervals (CIs)., Results: A total of six eligible (four randomized and two prospective nonrandomized) studies consisting of 432 patients (306 paroxysmal AF and 126 persistent AF) were included (RSDN + PVI group: 186 patients and PVI group: 246 patients). Follow-up is more than or equal to 1 year. Compared with PVI, RSDN + PVI significantly decreased the risk of AF recurrence (RR = 0.58, 95% confidence interval [CI] = 0.47-0.72, P < 0.00001) on follow-up. Fluoroscopy (MD = +5.53 minutes, 95% CI = 0.76-10.31, P = 0.02) and procedure time (MD = +34.85 minutes, 95% CI = 23.55-46.16, P < 0.00001) was significantly longer with the PVI + RSDN group compared with PVI alone. There were no significant differences in complications between both groups. Test of heterogeneity was low for all clinical outcomes (I 2  = 0%)., Conclusion: Our meta-analysis demonstrates that RSDN as an adjunct to PVI appears to be safe and improves clinical outcomes in both paroxysmal and persistent AF and history of hypertension., (© 2019 Wiley Periodicals, Inc.)

Introduction: Percutaneous left atrial appendage closure (LAAC) is typically performed utilizing transesophageal echocardiography (TEE) and fluoroscopy. Intracardiac echocardiography (ICE) can be a suitable alternative to guide implantation. Given the limited data, we performed a meta-analysis of all studies that compared ICE vs TEE for percutaneous LAAC., Methods: A comprehensive literature search was performed in PubMed, Embase, Scopus, Google Scholar, and major scientific conference sessions for published abstracts and manuscripts until 1 August 2018. Studies reporting clinical outcomes comparing TEE vs ICE for endocardial LAAC in human subjects aged greater than or equal to 18 years were included. Two investigators independently extracted the data and individual quality assessment was performed. The analysis was performed using Cochrane Collaboration software, RevMan 5.3., Results: Five eligible studies consisting of 1157 patients (ICE-391 patients and TEE-766 patients) were included. Four studies were retrospective and one was prospective, nonrandomized. Two studies included Watchman, two included the Amplatzer Cardiac Plug/Amulet device, and one included both devices. There was no significant difference in CHA2DS2VASC or HAS-BLED scores between both groups. There was no significant difference in acute procedural success between ICE vs TEE (risk ratio, 1.01; 95% CI, 0.99-1.04; P = 0.24). There was no significant difference in fluoroscopy time (mean difference [MD], 1.84 minutes; 95% CI, 0.59-4.27; P = 0.14) and total procedure time (MD, -5.06 minutes; 95% CI, -24.6-14.4; P = 0.61) between both groups. There was also no significant difference in complications including pericardial tamponade, device embolization, and stroke between both groups., Conclusion: In our meta-analysis, ICE was as effective as TEE during percutaneous LAAC., (© 2018 Wiley Periodicals, Inc.)

Background: Persistent left superior vena cava (PLSVC) is one of the most frequently reported congenital anomalies and may be an important source of trigger of atrial fibrillation (AF)., Methods: This was a multicenter retrospective experience including 28 patients with PLSVC who were referred for catheter ablation for drug-refractory symptomatic AF. Pulmonary vein and PLSVC isolation were performed (3.5-mm open irrigated tip ablation catheter at maximum power of 20 W, maximum temperature 43 °C with flow rate of 17 ml/min). Clinical outcomes such as complications and long-term freedom from AF were measured., Results: The mean age of the population was 61 ± 8 years, 21% were females, and AF duration was 60 ± 33 months. Sixty-one percent paroxysmal AF (17/28), 25% (7/28) persistent AF, and 14% (4/28) had long-standing persistent AF. There were no major complications that required any intervention. PLSVC isolation was achieved in 96% (27/28). Freedom from AF at 1 year without antiarrhythmic drugs was seen in 75% (21/28) of patients., Conclusions: In PLSVC patients with AF, segmental isolation of PLSVC appears to be feasible and safe and can translate into favorable clinical outcomes.

Background: Catheter ablation is an effective strategy for treatment of drug-refractory atrial fibrillation (AF). Continuation of oral anticoagulation (OAC) beyond 3 months after an apparently successful ablation of AF remains controversial., Methods: A systematic electronic search of the scientific literature was performed in PubMed, EMBASE, SCOPUS and Google Scholar. Studies comparing continuation vs discontinuation of OACs after an apparent successful ablation of AF among patients with CHA2DS2VASC or CHADS2 score ≥2were included. Clinical outcomes included cerebrovascular events, systemic thromboembolism and major bleeding. Risk ratios (RR) and 95% confidence intervals for above outcomes were calculated., Results: Nine observational studies were eligible and included 3,436patients of whom 1,815 continued OACs and1,621 discontinued OAC post -AF ablation. There was no significant difference in risk of cerebrovascular events (RR: 0.85, 95%CI: 0.42 to 1.70, p= 0.64)and systemic thromboembolism (RR: 1.21, 95%CI: 0.66 to 2.23, p= 0.54)between the two groups. Continuation of OACs was associated with an increased risk of major bleeding (RR: 6.50, 95% CI: 2.53 to 16.74, p= 0.0001)., Conclusion: In conclusion, discontinuation of oral anticoagulation 3 months after a successful AF ablation appears to be safe in highly selected closely monitored patients. Further randomized trials are warranted to assess the safety of discontinuing OACs after AF ablation.

Aim: To evaluate the safety and efficacy of surgical left atrial appendage occlusion (s-LAAO) during concomitant cardiac surgery., Methods: We performed a comprehensive literature search through May 31st 2018 for all eligible studies comparing s-LAAO vs no occlusion in patients undergoing cardiac surgery. Clinical outcomes during follow-up included: embolic events, stroke, all-cause mortality, atrial fibrillation (AF), reoperation for bleeding and postoperative complications. We further stratified the analysis based on propensity matched studies and AF predominance., Results: Twelve studies (n = 40107) met the inclusion criteria. s-LAAO was associated with lower risk of embolic events (OR: 0.63, 95%CI: 0.53-0.76; P < 0.001) and stroke (OR: 0.68, 95%CI: 0.57-0.82; P < 0.0001). Stratified analysis demonstrated this association was more prominent in the AF predominant strata. There was no significant difference in the incidence risk of all-cause mortality, AF, and reoperation for bleeding and postoperative complications., Conclusion: Concomitant s-LAAO during cardiac surgery was associated with lower risk of follow-up thromboembolic events and stroke, especially in those with AF without significant increase in adverse events. Further randomized trials to evaluate long-term benefits of s-LAAO are warranted., Competing Interests: Conflict-of-interest statement: The authors declare that they have no conflict of interest.

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.)

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.

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: 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, late >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., (Copyright © 2018 Heart Rhythm Society. Published by Elsevier Inc. All rights reserved.)

Left atrial appendage occlusion (LAAO) has emerged as an effective site-directed therapy in patients with nonvalvular atrial fibrillation (AF) for stroke prevention, who are ineligible for long-term oral anticoagulation. The objective of this study was to assess the safety, efficacy, and availability of LAAO devices by reviewing the literature and to review the development and effectiveness of LAAO by the transcatheter approach with plugging devices such as WATCHMAN™ (Boston Scientific, Natick, MA, USA); AMPLATZER™ Cardiac Plug and AMPLATZER™ Amulet™ (Abbott Laboratories, Chicago, IL, USA); and the LARIAT ® Suture Delivery Device (SentreHEART, Redwood City, CA, USA), which features an entirely unique hybrid (endocardial and epicardial) approach in closing the left atrial appendage (LAA). The conducted literature review ultimately revealed a substantial body of literature supporting the safety and efficacy of various LAAO strategies, including endocardial, epicardial, and hybrid approaches, in AF patients who are not eligible for long-term oral anticoagulant use. Specifically, the most attractive population suitable for LAA closure appears to be patients at high risk for ischemic stroke with a longer life expectancy but a moderate-to-high bleeding risk with long-term oral anticoagulation. The benefit of LAA closure in reducing the incidence of stroke in patients with nonvalvular AF has been evolving gradually, and we are confident that this new field of percutaneous LAA closure will continue to emerge as a game-changer in the treatment of AF., Competing Interests: The authors report no conflicts of interest for the published content. There was no financial involvement of a pharmaceutical or other company in this study., (Copyright: © 2018 Innovations in Cardiac Rhythm Management.)

Left atrial appendage closure (LAAC) has emerged as a viable option for stroke prevention, especially in those intolerant of or not suitable for long-term oral anticoagulation therapy. This article describes the clinical characteristics, indications, and a proposed referral system for potential LAAC patients. Patient selection remains a challenge because of the paradox between the available randomized data on this intervention and the actual patient population who may gain maximum benefit. Further investigations comparing different LAAC devices with each other and with novel oral anticoagulants are needed. Also, the optimal antithrombotic regimen post-procedure has yet to be determined., (Copyright © 2017 Elsevier Inc. All rights reserved.)

Introduction: The rates of cardiac implantable electronic device (CIED) infections have risen over the past decade and are associated with increased hospitalizations and mortality. A number of preventative strategies have been developed including an antibiotic coated envelope, but it has yet to gain widespread use., Methods: A meta-analysis was performed on controlled studies of the antibiotic envelope. PubMed and Google Scholar were searched for studies comparing infection rates with and without the use of an antibiotic envelope. Studies including both new implants and pulse generator replacements were included in the analysis., Results: Five studies were included in the meta-analysis. A total of 4,490 patients underwent CIED implantation, 1,798 with an antibiotic envelope and 2,692 without an envelope. In the pooled cohort, the envelope was associated with a 69% relative risk reduction in CIED infection (0.31 [0.17, 0.58] 95% CI, P = 0.0002). Propensity matched data from three studies were analyzed to ensure accurate comparison. In the risk-matched cohort, infections were significantly lower in the envelope group (3 vs. 26, P < 0.0003)., Conclusion: The use of antibiotic envelopes in CIED implant is associated with a significantly lower rate of infection., (© 2018 Wiley Periodicals, Inc.)

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.)

Background: We sought to investigate and compare the safety and efficacy of two commonly used antiarrhythmic drugs, Dofetilide (DF) and Sotalol (SL), during inpatient drug initiation in patients with symptomatic atrial fibrillation (AF)., Methods: We performed a single center retrospective study of consecutive patients, admitted for initiation of either DF or SL, for AF between 2012 and 2015. Rates of successful cardioversion, QT interval prolongation, adverse events and drug discontinuations were calculated and compared. A two-tailed p value less than 0.05 was considered statistically significant., Results: Of 378 patients, 298 (78.8%) received DF and 80 (21.2%) SL, mean age was 64 ± 11 years, 90% were Caucasians and 66% were males. Among the patients who remained in AF upon admission (DF: 215/298 (72%) vs. SL: 48/80 (60%)), no significant differences were noted in pharmacological cardioversion rates (DF: 125/215(58%) vs. SL: 30/48 (62.5%); p = 0.58). Baseline QTc was similar between the groups, with higher dose dependent QTc prolongation with DF (472.25± 31.3 vs. 458± 27.03; p = 0.008). There were no significant differences in the rates of adverse events such as bradycardia (7.4% vs. 11.3%; p = 0.26), Torsades de pointes (1.3% vs. 1.2%; p = 1.00), and drug discontinuation (9.0% vs. 5.0%; p = 0.47) between the two groups.

Objectives: This study sought to evaluate the clinical outcomes of patients receiving hemodynamic support (HS) during ventricular tacchycardia (VT) ablation., Background: There are limited real-world data evaluating its effect of HS in ablation outcomes., Methods: An analysis of 1,655 patients from the International VT Ablation Center Collaborative group was performed. A total of 105 patients received HS with percutaneous ventricular assist device., Results: Patients in the HS group had lower left ventricular ejection fraction (LVEF), higher New York Heart Association (NYHA) functional class, and more implantable cardioverter-defibrillator (ICD) shocks, VT storm, and antiarrhythmic drug use (all p < 0.05). The HS group also required significantly longer fluoroscopy, procedure, and total lesion time. Acute procedural success (71.8% vs. 73.7%; p = 0.04) was significantly lower and complications (12.5% vs. 6.5%; p = 0.03) and 1-year mortality (34.7% vs. 9.3%; p < 0.001) were significantly higher in the HS group. Multivariate Cox regression analysis demonstrated HS as an independent predictor of mortality (hazard ratio: 5.01; 95% confidence interval: 3.44 to 7.20; p < 0.001). There was no significant difference in VT recurrence between groups. In a subgroup analysis including LVEF ≤20% and NYHA functional class III to IV patients, acute procedural success (74.0% vs. 70.5%; p = 0.8), complications (15.6% vs. 7.8%; p = 0.2), VT recurrence (30.2% vs. 38.1%; p = 0.44), and 1-year mortality (40.0% vs. 28.8%; p = 0.2) were no different between the HS and no-HS groups., Conclusions: Patients requiring HS were sicker with multiple comorbidities and, as expected, had a significantly higher 1-year mortality than did those patients in the no-HS group. In patients with LVEF ≤20% and NYHA functional class III to IV, there was also no significant difference in clinical outcomes when compared with no HS. Further studies are needed to systematically evaluate patients undergoing VT ablation receiving HS., (Copyright © 2017 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Objectives: The present study describes the use of octreotide (OCT) in patients with atrial fibrillation (AF) receiving oral anticoagulation (OAC) who have gastrointestinal (GI) bleeding related to arteriovenous malformations (AVMs), as well as its effect on OAC tolerance and subsequent rebleeding., Background: AVMs cause significant GI bleeding, especially in patients with AF who are receiving OAC for stroke prevention. OCT has been shown to minimize recurrent GI bleeds related to AVMs., Methods: In a multicenter, observational study, 38 AF patients with contraindications to OAC because of AVM-related GI bleeding were started on 100 μg of subcutaneous OCT twice daily. OAC was resumed in all patients within 48 h. Incidence of recurrent GI bleeds was calculated, and hemoglobin levels were recorded at enrollment and at 3 and 6 months' follow-up., Results: After a median follow-up of 8 months, 36 patients (mean age 69 ± 8.0 years; mean CHA 2 DS 2 -VASc score 3 ± 1 and mean HAS-BLED score 3 ± 1) were available for analysis. All were able to successfully resume OAC, and 28 of 36 (78%) remained on OAC at the conclusion of the study, whereas 8 underwent left atrial appendage closure with subsequent OAC discontinuation. No systemic thromboembolic events occurred in follow-up. Of the 28 patients who continued receiving OAC, 19 (68%) were free of recurrent GI bleed, 4 had minor GI bleeds, 4 required transfusion, and 1 required colectomy for GI bleeding. Mean hemoglobin levels in all patients receiving OAC were significantly higher at 3- and 6-month follow-up than at baseline (p < 0.001)., Conclusions: Subcutaneous OCT therapy is an attractive option in AF patients receiving OAC who have AVM-related GI bleeds. It allows successful reinitiation of OAC as a bridge to left atrial appendage exclusion or short-term relief from bleeding., (Copyright © 2017. Published by Elsevier Inc.)

Background: There are limited studies on the safety and efficacy of remote magnetic navigation (RMN) versus manual navigation (MAN) in ventricular tachycardia (VT) ablation., Methods: A comprehensive literature search was performed using the keywords VT ablation, stereotaxis, RMN and MAN in Pubmed, Ebsco, Web of Science, Cochrane, and Google scholar databases., Results: The analysis included seven studies (one randomized, three prospective observational, and three retrospective) including 779 patients [both structural heart disease (SHD) and idiopathic VT] comparing RMN (N = 433) and MAN (N = 339) in VT ablation. The primary end point of long-term VT recurrence was significantly lower with RMN (OR 0.61, 95% CI 0.44-0.85, p = 0.003) compared with MAN. Other end points of acute procedural success (OR 2.13, 95% CI 1.40-3.23, p = 0.0004) was significantly higher with RMN compared with MAN. Fluoroscopy [mean difference -10.42, 95% CI -12.7 to -8.1, p < 0.0001], procedural time [mean difference -9.79, 95% CI -19.27 to -0.3, p = 0.04] and complications (OR 0.35, 95% CI 0.17-0.74, p = 0.0006) were also significantly lower in RMN when compared with MAN. In a subgroup analysis SHD, there was no significant difference in VT recurrence or acute procedural success with RMN vs. MAN. In idiopathic VT, RMN significantly increased acute procedural success with no difference in VT recurrence., Conclusion: The results demonstrate that RMN is safe and effective when compared with MAN in patients with both SHD and idiopathic VT undergoing catheter ablation. Further prospective studies are needed to further verify the safety and efficacy of RMN.

Background: A significant proportion of patients treated with warfarin for atrial fibrillation (AF) become warfarin ineligible (WI) due to major bleeding events (MBE) or systemic thromboembolism (STE). We report a large multicenter real-world experience of the use of direct oral antagonists (DOACs) in these WI patients., Methods: We report the outcomes of 263 WI patients treated with DOACs. The primary objective was to evaluate clinical outcomes of STE and MBE with DOACs. Secondary objective was to assess clinical predictors of repeat MBE and STE on DOACs., Results: Note that 63% (166 of 263) patients had a repeat MBE on DOACs. Repeat MBE was significantly higher in patients with prior gastrointestinal bleeding (74.5% vs. 30%, P < 0.0001). Five percent (12 of 263) developed repeat STE. Higher mean CHA2DS2VASC (6.5 ± 1.7 vs. 3.3 ± 1.6 = 0.001) score was associated with repeat STE. About 34% (57 of 166) of patients had an intervention to manage repeat MBE. LAAO devices were successfully used in 67% (12 of 18) high-risk patients who underwent major interventions to manage MBE., Conclusion: In WI patients rechallenged with DOACs, a significant proportion developed repeat MBE. LAAO devices seem reasonable in those patients who undergo major interventions to manage MBE with cautious and temporary continuation of DOAC., (© 2017 Wiley Periodicals, Inc.)

Background: Pocket hematoma is a recognized complication after placement of cardiac implantable electronic devices and is associated with increased device infection, length of hospitalization, and morbidity especially with uninterrupted antiplatelet agents and anticoagulants. We assessed the use of a post-surgical vest to decrease the incidence of pocket hematoma in patients undergoing device implantation with uninterrupted antiplatelet and anticoagulants., Methods: In this observational study, a vest was used by 20 consecutive patients who were compared to 20 age-, gender-, procedure-matched patients who received standard care. All patients were continued on antiplatelet and anticoagulants in the perioperative period. The pocket was assessed at post procedure day 0, 2, and 7, respectively., Results: There were no significant differences in the baseline characteristics between both groups. Baseline mean international normalized ratio (INR) was significantly higher in the vest group when compared with the control group (2.7 ± 0.4 vs. 2.2 ± 0.3 = <0.001). The incidence of pocket hematoma was significantly lower in the vest group than the control group (0 vs 30%, p = 0.02) at the end of 7 days. Control group had a total of six hematomas with one patient requiring evacuation and blood transfusion. The vest group had three hematomas on day 2 that resolved by day 7., Conclusions: The risk of moderate or large pocket hematoma is significantly reduced with the use of this vest in high-risk patients undergoing implantable devices on uninterrupted antiplatelet and anticoagulants.

Background: Dofetilide is a class III antiarrhythmic drug that has been reported to be safe and efficacious in the treatment of atrial dysrhythmias with a known initial risk of QT prolongation and torsades de pointes (TdP). As a result, the Federal Drug Administration (FDA) mandated in-hospital dofetilide initiation and adherence to a common dosing protocol. However, there is a lack of clarity on how to manage dofetilide re-initiation., Methods: An observational survey was performed including 347 cardiologists in the United States and worldwide to evaluate the deviations from approved manufacturer's protocol during dofetilide initiation and re-initiation among practicing cardiologists., Results: Most practicing cardiologists were cautious about outpatient dofetilide use and adhered to the manufacturer's in-patient dofetilide protocol during de-novo initiation and reported low incidence of TdP in clinical practice. There were substantial differences among practicing cardiologists with deviation from the manufacturer's protocol during re-initiation of dofetilide. About 21% cardiologists always admitted patients to the hospital while 37% admitted patients <10% of the time for dofetilide re-initiation. Only 4% reported major adverse events with outpatient dofetilide re-initiation. There was also wide variation regarding monitoring of electrolytes and QT interval as an outpatient with dofetilide., Conclusion: There is significant practice pattern variation in the use of dofetilide for the management of AF. This degree of variation noted is concerning and is a reflection of the current lack of substantial clinical evidence in the re-initiation dofetilide protocol to help direct the provider., (Copyright © 2017. Published by Elsevier B.V.)

Background: There have been an increasing number of atrial fibrillation (AF) patients with Watchman left atrial appendage occlusion (LAAO) device, requiring catheter ablation (CA) for maintenance of normal sinus rhythm. In this study, we describe our experience with the feasibility and safety of CA in patients with a preexisting Watchman LAAO device., Methods: This was a retrospective multicenter AF registry of 60 patients with Watchman LAAO device who underwent CA for AF. Baseline clinical and procedural characteristics of the included subjects were retrieved from review of medical records and were analyzed., Results: The mean age was 72.7 ± 4.9 years and the mean CHADS2 score was 2.3 ± 0.6. All patients had successful pulmonary vein isolation (PVI). The left atrial appendage (LAA) was electrically active in 34 (56%) while reentrant tachycardia and AF triggers were seen in 17 (28%) patients. Electrical isolation was attempted in these 17 patients with only 10 achieving complete LAA isolation. Repeat imaging showed new peri-device leaks in 30% (12/40) patients, while new significant peri-device leaks (≥5 mm) were noted in 10% (10/40) of patients after RFA, respectively, requiring continuation of oral anticoagulation. There were a higher proportion of patients with severe peri-device leaks (≥5 mm) after LAA isolation. However, >50% of those leaks sealed off on follow-up transesophageal echocardiogram., Conclusion: AF ablation is a feasible and safe in patients with preexisting Watchman LAAO device. Electrical isolation of the LAA could be difficult and when attempted can result in increased risk of short-term peri-device leak and recurrence of AT/AF in almost all patients., (© 2016 Wiley Periodicals, Inc.)

Medical errors, especially due to misinterpretation of electrocardiograms (ECG), are extremely common in patients admitted to the hospital and significantly account for increased morbidity, mortality and health care costs in the United States. Inaccurate performance of an ECG can lead to invalid interpretation and in turn may lead to costly cardiovascular evaluation. We report a retrospective series of 58 sequential cases of ECG limb lead reversals in the ER due to inadvertent interchange in the lead cables at the point where they insert into the cable junction box of one ECG machine. This case series highlights recognition of ECG lead reversal originating in the ECG machine itself. This case series also demonstrates an ongoing need for education regarding standardization of ECG testing and for recognizing technical anomalies to deliver appropriate care for the patient., (Copyright © 2016. Published by Elsevier Inc.)

Objective: We aimed to perform a meta-analysis from eligible studies to analyze the true impact of QL when compared with BL with regard to post-procedural outcomes including lead deactivation, revision or replacement. Background: Many observational and retrospective studies showed that quadripolar left ventricular leads (QL) are associated with better outcomes and fewer complications when compared with bipolar leads (BL). Methods: We performed a comprehensive literature search through June 30, 2015 using: quadripolar, bipolar, left ventricular lead and CRT in Pubmed, Ebsco and google scholar databases. Results: The analysis included 8 studies comparing QL and BL implantation. Post-procedural outcomes such as lead deactivation, revision or replacement were used as primary outcome and assessed with Mantel-Haenszel risk ratio (RR). Secondary outcomes included total fluoroscopy/procedure time, occurrence of phrenic nerve stimulation (PNS) and all-cause mortality on follow up. Follow-up duration for the studies ranged from 3 to 60 months. Compared with BL, the use of QL is associated with 52 % reduction (relative risk 0.48; 95% CI: 0.36-0.64, p=0.00001) in the risk of deactivation, revision or replacement of the LV lead. QL had significantly lower fluoroscopy/procedure time, PNS and all-cause mortality when compared with BL. Conclusion: Our meta-analysis shows that QL implantation was associated with decreased risk of LV lead deactivation, revision or replacement when compared with BL.

Postoperative atrial fibrillation (PoAF), a common complication of cardiac surgery, contributes significantly to morbidity, mortality, and increasing healthcare costs. Despite advances in surgical and medical management, the overall incidence of PoAF has not changed significantly, partly because of the limited understanding of mechanisms underlying acute surgery-related factors, such as myocardial injury, inflammation, sympathetic activation, and oxidative stress, which play an important role in the initiation of PoAF, whereas a preexisting atrial substrate appears to be more important in the maintenance of this dysrhythmia. Thus, in a majority of patients, PoAF becomes a manifestation of an underlying arrhythmogenic substrate that is unmasked after acute surgical stress. As such, the ability to identify which patients have this proarrhythmic substrate and are, therefore, at high risk for developing AF postoperatively, is important for the improved selection for prophylactic interventions, closer monitoring for complications, and establishing the probability of AF in the long term. This review highlights the role of the underlying substrate in promoting PoAF, proposed mechanisms, and the potential role of serum biomarkers to identify patients at risk for PoAF.

Atrial fibrillation (AF) is the most common cardiac arrhythmia in athletes, especially in middle-aged athletes. Studies have demonstrated that athletes who engage in endurance sports such as runners, cyclists and skiers are more prone to AF than other athletes. The effects of exercise on the onset and progression of AF is complex. Triggers of AF in athletes may include atrial ectopy and sports supplements. Substrates for AF in athletes include atrial remodeling, fibrosis, and inflammation. Modulators of AF in athletes include autonomic activation, electrolyte abnormalities, and possibly, gastroesophageal reflux. Management of AF in athletes with rate-controlling agents and antiarrhythmic drugs remains a challenge and can be associated with impaired athletic performance. The value of catheter ablation is emerging and should be considered in suitable athletes with AF.

Atrial fibrillation (AF) is the most prevalent cardiac arrhythmia in the United States and worldwide. Caffeine, alcohol, and, more recently, energy drinks are the most commonly consumed beverages in daily living, especially by young individuals. Several questions have been raised about the implications of caffeine, alcohol, and energy drinks in cardiovascular health, especially in triggering AF. This review focuses on the role of these commonly consumed beverages as a cause of AF, with special emphasis of potential mechanisms and studies addressing this issue., (© 2015 Wiley Periodicals, Inc.)

Atrial fibrillation (AF) complicating cardiac surgery continues to be a major problem that increases the postoperative risk of stroke, myocardial infarction, heart failure and costs and can affect long-term survival. The incidence of AF after surgery has not significantly changed over the last two decades, despite improvement in medical and surgical techniques. The mechanism and pathophysiology underlying postoperative AF (PoAF) is incompletely understood and results from a combination of acute and chronic factors, superimposed on an underlying abnormal atrial substrate with increased interstitial fibrosis. Several anti-arrhythmic and non-anti-arrhythmic medications have been used for the prevention of PoAF, but the effectiveness of these strategies has been limited due to a poor understanding of the basis for the increased susceptibility of the atria to AF in the postoperative setting. In this review, we summarize the pathophysiology underlying the development of PoAF and evidence behind pharmacological approaches used for its prevention in the postoperative setting.

Several new oral anticoagulants (NOAC) have been recently studied and approved for the prevention and treatment of venous thromboembolism (VTE) which includes deep vein thrombosis and pulmonary embolism. Although, NOACs possess several advantages when compared to traditional therapy each has its own limitations; especially in the elderly and in patients with low body weight, renal impairment and in those with high risk of bleeding. Apixaban is a factor Xa inhibitor recently approved for the treatment and prevention of VTE in the United States. The purpose of this manuscript is to review describes the pharmacological properties of NAOC's and to discuss clinical trial results and clinical applications of these agents in the prevention and treatment of VTE with special emphasis on the role of apixaban.

Patients with advanced chronic kidney disease (CKD), including those treated with dialysis, are at high risk for the development of cardiovascular disease (CVD). CVD accounts for 45-50% of deaths among dialysis patients. Therapy of acute and chronic coronary heart disease (CHD) that is effective in the general population is frequently less effective in patients with advanced CKD. Drug therapy in such patients may require dose modification in some cases. Oral anti-platelet drugs are less effective in those with advanced CKD than in persons with normal or near normal renal function. The intravenous antiplatelet drugs eptifibatide and tirofiban both require dose reductions in patients with advanced CKD. Enoxaparin requires dose reduction in early stage CKD and is contraindicated in hemodialysis patients. Unfractionated heparin and warfarin maybe used without dose adjustment in CKD patients. Atenolol, acetbutolol and nadolol may require dose adjustments in CKD. Metoprolol and carvedilol do not. Calcium channel blockers and nitrates do not require dose adjustment, whereas ranolazine does. Angiotensin converting enzyme inhibitors and angiotensin receptor blockers may safely be used in CKD patients with close observation for hyperkalemia. The safety of spironolactone in such patients is questionable. Statins are less effective in reducing cardiovascular complication in CKD patients and their initiation is not recommended in dialysis patients. Coronary artery bypass grafting is associated with higher shortterm mortality, but better long-term morbidity and mortality than percutaneous coronary interventions in patients with advanced CKD with non-ST segment ACS and chronic CHD.

Atrial fibrillation (AF) is the most prevalent cardiac arrhythmia and approximately 18-45% of AF patients have concomitant coronary artery disease (CAD). Several studies have demonstrated that oral anticoagulation is the mainstay of therapy for stroke prevention in AF. Similarly, antiplatelet therapy including aspirin and P2Y12 inhibitor is recommended in the management of acute coronary syndrome and stable CAD. Despite the high prevalence of CAD with AF, practice guidelines are scarce on the appropriate antithrombotic regimen due to lack of large-scale randomized clinical trials. The use of direct thrombin and factor Xa inhibitors for stroke prevention in AF has also complicated the possible combinations of antithrombotic therapies. This review aims to discuss the available evidence regarding aspirin as an antithrombotic strategy, the role of novel anticoagulants and the specific clinical situations where aspirin may be beneficial in patients with AF and CAD.

Warfarin has remained the mainstay of stroke prevention in atrial fibrillation for the past 60 years. Recently, two new groups of novel oral anticoagulants- direct thrombin inhibitors (dabigatran) and factor Xa inhibitors (rivaroxaban, apixaban, edoxaban) have shown promising results in well conducted clinical trials in terms of efficacy, safety and convenience of usage. However, in real world practice these novel agents come with their share of side effects and drawbacks which the prescribing physician must be aware about. In this review we discuss the role of these novel agents in real world clinical practice - their advantages, disadvantages and future directions.

Atrial fibrillation (AF) is about three-times more prevalent in patients with chronic kidney disease and the prevalence of AF increases with the degree of renal impairment. Clinical studies have shown increased risk of stroke, bleeding and death in patients with chronic kidney disease and AF. Despite, this increased risk, anticoagulation is underutilized due to increased bleeding risk in this population. Recently direct thrombin inhibitors and factor Xa inhibitors have been shown to be more efficacious in stroke prevention with reduced bleeding than warfarin. As the usage of these novel anticoagulants increases it is important to understand the data available in regard to these high risk patients.

Based on the clinical trials so far, there is a major controversy regarding the benefit of CRT in patients with QRS≤150 milliseconds. Some studies have shown that a fair number of patients with QRS≤150 milliseconds benefit from CRT and it is needless to say that careful attention should be paid to CRT non-responders considering the risk of complications and cost-benefit ratio. Lack of uniformity in QRS measurement in all these trials could have a major influence on variable study outcomes. This is of concern because when the QRS is close to 120 milliseconds in patients with NYHA class III/IV symptoms or QRS close to 150 milliseconds in NYHA class I/II patients, the decision to recommend CRT implantation or undertake further risk stratification investigations is critically dependent on the EKG interpretation. In this paper we intent to raise the important question for need of standardized electrocardiographic criteria (QRS measurement and LBBB) in patients enrolled in CRT trials considering the variability in study results, high rates of CRT non response in the eligible population and the associated health care cost burden.