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Introduction: The role of secondary prevention implantable cardioverter-defibrillator (ICD) remains uncertain in spontaneous coronary artery dissection (SCAD) patients presenting with sudden cardiac arrest (SCA)., Methods: We aimed at assessing the outcomes following SCA and the role of ICD therapy in SCAD. The meta-analysis was performed using a meta-package for R version 4.0/RStudio version 1.2 and the Freeman-Tukey double arcsine method to establish the variance of raw proportions. Outcomes measured included-(1) incidence of ICD implantation, (2) appropriate and inappropriate ICD therapy, (3) recurrence of SCAD and SCA, and (4) all-cause mortality., Results: Five studies, including 139 SCAD patients with SCA met study inclusion criteria. The mean age was 47.3 ± 12.8 years, mean left ventricular ejection fraction 43.8 ± 10.8%, 88% were female (12% had pregnancy-associated SCAD. Causes of SCA included ventricular arrhythmia (97.9%, n = 136) and pulseless electrical activity (2.1%, n = 3). Overall, 20% patients (95% confidence interval [CI]: 7.1%-36.6%, I 2 = 68%) received ICD, of which 1.2% (95% CI: 0%-15.8%, I 2 = 0%) and 1% (95% CI: 0%-15.3%, I 2 = 0%) patients received appropriate and inappropriate ICD therapies, respectively, during follow-up period (4.1 ± 3.3 years). Incidence of recurrent SCAD was 9% (95% CI: 2.85%-17.5%, I 2 = 25%), and recurrent SCA was 3.85% patients (95% CI: 0.65%-8.7%, I 2 = 0%; one patient with appropriate ICD therapy). The pooled incidence of all-cause mortality was 6.2% (95% CI: 0.6%-15.1%, I 2 = 44%)., Conclusion: Although ICD therapy is beneficial in patients (all comers) presenting with cardiac arrest; the risk-benefit ratio of secondary prevention ICD arrest remains unclear. Patient-centered shared decision-making and risk-benefit ratio assessment should be performed before consideration for ICD implantation., (© 2021 Wiley Periodicals LLC.)

Objective: To assess the safety and efficacy of a novel immunosuppressive regimen-combination Methotrexate/Prednisone (cMtx/P)-in the management of severe refractory rPPP., Methods: In this multicenter, nonrandomized, retrospective, observational study, 408 consecutive patients diagnosed with persistent rPPP between 2017 and 19 were included. Patients with refractory symptoms despite 3 months of conventional therapy were initiated on a 4-week regimen of oral steroids. Persistence of symptoms at this point, that is, rPPP (n = 25; catheter based = 18, open surgical = 7) prompted therapy with Methotrexate (7.5-15 mg weekly) with folate supplementation along with low dose prednisone (5 mg PO) for a further 3 months. Patients were followed for a total of 11.3 ± 1.8 months., Results: Treatment refractory rPPP occurred in 6.1% of the study population prompting immunosuppressive therapy with cMtx/P. All patients demonstrated complete symptom resolution following 3 months of treatment with an 85% decline in clinically significant pericardial effusions. One patient developed recurrent pericarditis during the 11-month follow-up. Therapy was well tolerated with no significant drug related adverse effects., Conclusion: cMtx/P therapy is a safe and effective adjunct in the management of rPPP refractory to standard therapy., (© 2021 Wiley Periodicals LLC.)

Introduction: The LARIAT epicardial suture snaring device has been fraught with technical challenges and procedural complications. Over time, technique modification and improved operator experience have helped overcome many of these challenges. METHODS AND RESULTS: Studies reporting left atrial appendage epicardial closure over a 12-year period from 2009 to 2020 were evaluated. The primary efficacy outcome evaluated was left atrial appendage closure with residual flow ≤1 mm. Safety outcomes evaluated were periprocedural and long term complications after device placement. Nine studies consisting of 1430 patients were included in this analysis, of which 1386 (97%) underwent successful device placement. The mean age was 69.3 years, with a mean CHADS 2 -VASC score of 3.78. Primary efficacy end point was achieved in 95.8% patients immediately after device placement, and in 92.8% patients on long term follow-up. Early procedural complications consisted of pericardial effusion 5.6%, cardiac perforation 2.7%, pericarditis 2.6%, and need for open heart surgery 1.5%. Long term complications consisted of all-cause mortality 2.3%, stroke 1.5%, and left atrial appendage thrombus 2.3%. Reduced complications were noted using micropuncture needles (2.20% vs. 10.14%; p < .0001), a longer duration pericardial drainage, and use of anti-inflammatory medications (1.58% vs. 8.4%). Oral anticoagulation use decreased from 44.7% to 22.9% post device implantation, and to 8.5% on last clinical follow up., Conclusions: The LARIAT device is effective in epicardial closure of the left atrial appendage. Improvement in device techniques such as use of micropuncture needle, prophylactic colchicine, and maintenance of a pericardial drain have helped improve safety over time., (© 2021 Wiley Periodicals LLC.)

The thromboembolic complications of Atrial fibrillation (AF) remain a major problem in contemporary clinical practice. Despite advances and developments in anticoagulation strategies, therapy is complicated by the high risk of bleeding complications and need for meticulous medication compliance. Over the past few decades, the left atrial appendage has emerged as a promising therapeutic target to prevent thromboembolic events while mitigating bleeding complications and compliance issues. Emerging data indicates that it is a safe, effective and feasible alternative to systemic anticoagulation in patients with non-valvular AF. A number of devices have been developed for endocardial or epicardial based isolation of the left atrial appendage. Increasing experience has improved overall procedural safety and ease while simultaneously reducing device related complication rates. Furthermore, increasing recognition of the non-mechanical advantages of this procedure has led to further interest in its utility for further indications beyond the prevention of thromboembolic complications. In this review, we present a comprehensive overview of the evolution of left atrial appendage occlusion, commercially available devices and the role of this modality in the current management of AF. We also provide a brief outline of the landmark trials supporting this approach as well as the ongoing research and future prospects of left atrial appendage occlusion., (© 2021 Wiley Periodicals LLC.)

Background: Warfarin is traditionally the drug of choice for stroke prophylaxis or treatment of venous thromboembolism in patients with end-stage renal disease (ESRD) on hemodialysis as data on apixaban use is scarce. We aimed to assess the safety and efficacy of Apixaban in patients with ESRD on hemodialysis when compared with warfarin., Methods: A comprehensive literature search in PubMed, Google Scholar, and Cochrane databases from inception until Nov 25, 2019, was performed. Studies reporting clinical outcomes comparing Apixaban (2.5 mg BID or 5 mg BID) versus Warfarin in ESRD patients on hemodialysis were included. Mantel-Haenszel risk ratio (RR) random-effects model was used to summarize data., Results: Four studies (three retrospective and one randomized) with a total of 9862 patients (apixaban = 2,547, warfarin = 7315) met inclusion criteria. The overall mean age was 66.6 ± 3.9 years and mean CHA2DS2-VASc score 4.56 ± 0.58. Apixaban was associated with lower rates of major bleeding (RR 0.53, 95% CI 0.45-0.64, p < 0.0001], gastrointestinal (GI) bleed (RR 0.65, 95% CI 0.55-0.76, p < 0.0001), intracranial bleed (RR 0.56, 95% CI 0.36-0.89, p = 0.01), and stroke/systemic embolism [RR 0.65, 95% CI 0.52-0.83, p = 0.0004] compared with warfarin in patients with ESRD on hemodialysis. There was no significant increased risk of all-cause mortality with the apixaban vs. warfarin (RR 0.90, 95% CI 0.41-1.96, p = 0.78)., Conclusion: Apixaban had an overall favorable risk-benefit profile, with significant reductions in ischemic stroke, major bleeding, and intracranial bleeding compared to Warfarin in ESRD patients on hemodialysis with non-valvular AF and/or venous thromboembolism., Competing Interests: Declaration of competing interest None., (Copyright © 2021 Indian Heart Rhythm Society. Production and hosting by Elsevier B.V. All rights reserved.)

Importance: Early rhythm control of atrial fibrillation (AF) with either antiarrhythmic drugs (AADs) or catheter ablation has been reported to improve cardiovascular outcomes compared with usual care; however, the optimal therapeutic modality to achieve early rhythm control is unclear., Objective: To assess the safety and efficacy of AF ablation as first-line therapy when compared with AADs in patients with paroxysmal AF., Data Sources: PubMed/MEDLINE, Scopus, Google Scholar, and various major scientific conference sessions from January 1, 2000, through November 23, 2020., Study Selection: Randomized clinical trials (RCTs) published in English that had at least 12 months of follow-up and compared clinical outcomes of ablation vs AADs as first-line therapy in adults with AF. The quality of individual studies was assessed using the Cochrane risk of bias tool. Six RCTs met inclusion criteria, including 1212 patients., Data Extraction and Synthesis: Two investigators independently extracted data. Reporting was performed in compliance with the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-analysis) guidelines. Analysis was performed using a random-effects model with the Mantel-Haenszel method, and results are presented as 95% CIs., Main Outcomes and Measures: Main outcomes were safety and efficacy of AF ablation as first-line therapy when compared with AADs. Trials were evaluated as having low risk of selection and attrition biases, high risk of performance bias, and with unclear risk for detection biases due to unblinding and open-label designs., Results: A total of 6 RCTs involving 1212 patients with AF were included (609 were randomized to AF ablation and 603 to drug therapy; mean [SD] age, 56 [11] years). Compared with AADs, catheter ablation use was associated with reductions in recurrent atrial arrhythmia (32.3% vs 53%; risk ratio [RR], 0.62; 95% CI, 0.51-0.74; P < .001; I2 = 40%), with a number needed to treat with ablation to prevent 1 arrhythmia of 5. Use of ablation was also associated with reduced symptomatic atrial arrhythmia (11.8% vs 26.4%; RR, 0.44; 95% CI, 0.27-0.72; P = .001; I2 = 54%) and hospitalization (5.6% vs 18.7%; RR, 0.32; 95% CI, 0.19-0.53; P < .001) with no significant difference in serious adverse events between the groups (4.2% vs 2.8%; RR, 1.52; 95% CI, 0.81-2.85; P = .19)., Conclusions and Relevance: In this meta-analysis of randomized clinical trials including first-line therapy of patients with paroxysmal AF, catheter ablation compared with antiarrhythmic drugs was associated with reductions in recurrence of atrial arrhythmias and hospitalizations, with no difference in major adverse events.

Introduction: Though current guidelines currently recommend using warfarin, there is also a growing interest in the utilization of direct oral anticoagulants (DOACs) to treat left ventricular (LV) thrombus., Methods: We performed a systematic search using PubMed, SCOPUS, EMBASE, Google Scholar, and ClinicalTrials.gov from inception to September 30, 2020, for studies that had reported outcomes in patients with left ventricular thrombus treated with DOACs (PROSPERO registration number CRD42020219761)., Results: Twelve studies (n = 867 patients) were included in the analysis. The pooled incidence of the systemic embolic events (SEE) with DOACs was 2.7%, whereas the thrombus resolution rate was 86.6%. The pooled incidence of overall bleeding (composite of major and minor bleeding) and major bleeding with DOACs were 5.6% and 1.1%, respectively. No significant difference was observed in terms of SEE (OR 0.81, 95% confidence interval [CI] 0.44-1.52, p = .54), major bleeding (OR 0.29, 95% CI 0.07-1.26, p = .24), and failure of LV thrombus resolution (OR 0.86, 95% CI 0.28-2.58, p = .68); whereas overall bleeding was significantly low in patients with LV thrombus treated with DOACs compared to vitamin K antagonists (VKAs) (OR 0.33, 95% CI 0.14-0.81, p = .02)., Conclusion: Our study demonstrates no significant difference in SEE, major bleeding, or failure of LV thrombus resolution between the two groups, thus demonstrating that DOACs are an efficacious and safe alternative for the treatment of LV thrombus compared to VKAs. However, further well-designed prospective trials are needed to answer important clinical questions-optimal dosing/duration of DOACs and its safety in the background of antiplatelet therapy., (© 2021 Wiley Periodicals LLC.)

Purpose: Phrenic and hypoglossal nerve pacing therapies have shown benefit in sleep apnea. We sought to analyze the role of pacing therapies in sleep apnea and their impact on heart failure., Methods: A comprehensive literature search in PubMed and Google Scholar from inception to August 5, 2019, was performed. A meta-analysis was performed using fixed effects model to calculate mean difference (MD) with 95% confidence interval (CI)., Results: Six studies were eligible and included 626 patients, of whom 334 were in the control arm and 393 were in the experimental arm. Phrenic nerve pacing (MD - 23.20 events/h, 95% CI - 27.96 to - 18.44, p < 0.00001) and hypoglossal nerve pacing (MD - 20.24 events/h, 95% CI - 23.22 to - 17.27, p < 0.00001) were associated with improvements in apnea-hypopnea index (AHI). Phrenic nerve pacing was associated with a trend towards improvements in left ventricular ejection fraction (MD 3.95%, 95% CI - 0.04 to 7.94, p = 0.05). Hypoglossal and phrenic nerve pacing were associated with improvements in the quality of life as assessed by improvements in Epworth sleepiness scale (MD 3.71 points, 95% CI 2.89 to 4.54, p < 0.00001)., Conclusions: Our analysis suggests that phrenic and hypoglossal nerve pacing improves AHI and quality of life with a trend towards improvement in left ventricular ejection fraction, especially in central sleep apnea. Complications were high but future refinement in technology will likely improve clinical outcomes and minimize complications.

Purpose: Idiopathic junctional ectopic tachycardia (JET) is typically refractory to antiarrhythmic agents. Catheter ablation for JET is feasible but is associated with high risk of unintended atrioventricular (AV) block. There is limited data on the appropriate procedural technique and clinical outcomes with catheter ablation for idiopathic JET in adults., Methods: This is a multicenter, retrospective study of all adult patients (age ≥ 18 years) who underwent catheter ablation for idiopathic JET. Patient, procedural characteristics, and long-term outcomes were evaluated., Results: Fifteen patients [radiofrequency ablation (RF) = 14 and cryoablation = 1) were treated with catheter ablation. The median age was 58 years with 67% males. All patients underwent mapping of the right atrium and the aortic cusps prior to energy delivery. The location of earliest activation in relation to the atrioventricular (AV) node was postero-superior in 73% (11/15), posterior in 13% (2/15), and superior in 13% (2/15) respectively. Acute success was 100%. Arrhythmia recurrence occurred in 53% (8/15) all of whom underwent a repeat ablation. High-grade AV block requiring permanent pacemaker occurred in 20% (3/15). At 12-month follow-up in the redo-ablation group, 37.5% (3/8) had recurrence of the arrhythmia two of which underwent a third ablation procedure., Conclusion: Catheter ablation of idiopathic JET in adults is associated with a high rate of recurrence requiring multiple procedures and high risk of AV block requiring a permanent pacemaker. Mapping and ablation of the non-coronary cusp can be considered as the arrhythmia was controlled in 3 patients with no inadvertent AV block.

Introduction: Renal sympathetic denervation (RSDN) is an alternate management approach for refractory ventricular arrhythmias (VAs). We aimed to perform a systematic review of clinical outcomes on the impact of RSDN on refractory VA patients., Methods: A systematic search without language restriction, using PubMed, EMBASE, SCOPUS, Google Scholar, and ClinicalTrials.gov from inception to August 18, 2020, was performed for the studies that reported outcomes in patients who underwent RSDN for VA. The outcomes studied were-(1) recurrent VA; and (2) all-cause mortality., Results: Five studies (from 2014 to 2018) with a total of 51 VA patients met study inclusion criteria. The mean age was 61.92 ± 11.76 years, and 78.4% were men. The pooled incidence of short-term (3 months or less) and long-term (more than 3 months) VA recurrence was 63.85% (95% CI 16.75 to 99.32) and 10.52% (95% CI 0.14 to 28.75), respectively. When stratified by the number of VA episodes, there was a significant reduction in mean VA episodes (SMD -3.79, 95% CI -6.59 to -0.98, p < .01), ICD shocks (SMD -1.71, 95% CI -3.0 to -0.42, p < .01) and anti-tachycardia pacing (SMD -1.21, 95% CI -1.98 to -0.44, p < .01) following RSDN denervation. The pooled incidence of all-cause mortality after RSDN was 10.16% (95% CI 1.08 to 24.12). There were no major vascular complications, one minor vascular complication-small non-flow limiting renal artery dissection (no intervention needed)., Conclusion: RSDN appears to be a safe and effective treatment strategy in patients with prior failed antiarrhythmic drugs and catheter ablation for recurrent ventricular arrhythmia and electrical storm., (© 2021 Wiley Periodicals LLC.)

Background: Left atrial appendage closure (LAAC) has proven to be an effective alternative to long-term oral anticoagulation in the prevention of thromboembolic events in patients with atrial fibrillation. In a minority of patients, inadequate seal may result in persistent peridevice flow and inability of the appendage to fully thrombose, thereby representing a potential source for thromboembolism., Objective: The purpose of this study was to study the use of endovascular coiling of the appendage to address persistent peridevice leak in patients undergoing LAAC with the Watchman device., Methods: This is a retrospective single-center analysis involving patients who underwent placement of a LAAC device and returned for endovascular coiling to address persistent device leak between 2018 and 2020. Baseline characteristics, procedural outcomes, and follow-up echocardiograms were analyzed to demonstrate the feasibility and safety of this technique., Results: Patients (N = 20) were identified with a mean leak size of 3.8 ± 1.3 mm (range 2.5-7 mm), all of whom had a non-thrombosed appendage. Acute procedural success was achieved in 95% of patients. Complete or significant reduction in flow beyond the LAAC device was achieved in 61% and 33% of patients, respectively. The 1 procedure-related adverse event was a pericardial effusion before coil deployment, requiring percutaneous drainage., Conclusion: The clinical impact of residual peridevice leak post-Watchman implantation is a matter of continuing investigation. However, appendage coiling represents a new therapeutic tool to address this potential source for thromboembolism. Further studies should address the clinical impact of this technique, including the safety of discontinuing anticoagulation after successful coiling., (Copyright © 2021 Heart Rhythm Society. Published by Elsevier Inc. All rights reserved.)

Background: Same-day discharge (SDD) after atrial fibrillation (AF) ablation is increasingly being considered. This study examined the barriers and financial impact associated with SDD in a contemporary cohort of patients undergoing elective AF ablation., Methods: A single center retrospective review was conducted of the 249 first case-of-the-day outpatient AF ablations performed in 2019 to evaluate the proportion of patients that could have undergone SDD. Barriers to SDD were defined as any intervention that prevented SDD by 8 p.m. The financial impact of SDD was based on savings from avoidance of the overnight hospital stay and revenue related to management of chest pain facilitated by a vacant hospital bed., Results: SDD could have occurred in 157 patients (63%) without change in management and in up to 200 patients (80%) if avoidable barriers were addressed. Barriers to SDD included non-clinical logistical issues (43%), prolonged post-procedure recovery (42%) and minor procedural complications (15%). On multivariate analysis, factors associated with barriers to SDD included increasing age (P = .01), left ventricular ejection fraction ≤ 35% (P = .04), and severely dilated left atrium (P = .04). The financial gain from SDD would have ranged from $1,110,096 (assuming discharge of 63% of eligible patients) to $1,480,128 (assuming 80% discharge) over the course of a year., Conclusions: Up to 80% of patients undergoing outpatient AF ablation were amenable to SDD if avoidable delays in care had been anticipated. Based on reduced hospital operating expenses and increased revenue from management of individuals with chest pain, this would translate to a financial savings of ∼$1.5 million., (© 2021 Wiley Periodicals LLC.)

Orthotropic heart transplantation remains the most effective therapy for patients with end-stage heart failure, with a median survival of ≈13 years. Yet, a number of complications are observed after orthotropic heart transplantation, including atrial and ventricular arrhythmias. Several factors contribute to arrhythmias, such as autonomic denervation, effect of the surgical technique, acute and chronic rejection, and transplant vasculopathy among others. To minimize risk of future arrhythmias, the bicaval technique and minimizing ischemic time are current surgical standards. Sinus node dysfunction is the most common indication for early (within 30 days) pacemaker implantation, whereas atrioventricular block incidence increases as time from transplant increases. Atrial fibrillation can occur in the first few weeks following transplantation but is uncommon in the long term unless secondary to a precipitant such as acute rejection. The most common atrial arrhythmias are atrial flutters, which are mainly typical, but atypical circuits can be observed such as those that involve the remnant donor atrium in regions immediately adjacent to the atrioatrial anastomosis suture line. Choosing the appropriate pharmacological therapy requires careful consideration due to the potential interaction with immunosuppressive agents. Despite historical concerns, adenosine is effective and safe at reduced doses if administered under cardiac monitoring. Catheter ablation has emerged as an effective treatment strategy for symptomatic supraventricular tachycardias, including ablation of atypical flutter circuits. Cardiac allograft vasculopathy is an important risk factor for sudden cardiac death, yet the role of prophylactic implantable cardioverter-defibrillator implant for sudden death prevention is unclear. Current indications for implantable cardioverter-defibrillator implantation are as in the nontransplant population. A number of questions for future research are posed.

Background: The next-generation Watchman FLX left atrial appendage closure (LAAC) device has: (1) an atraumatic closed distal end, (2) reduced height, (3) a recessed screw hub to decrease device-related thrombus (DRT), (4) two rows of J-shape anchors so redeployment is possible after full recapture, and (5) ability to treat a greater size range of LAA ostia., Objective: To report, for the first time, the feasibility and safety of intracardiac echocardiography (ICE)-guided Watchman FLX implantation., Methods: A single-center prospective registry of atrial fibrillation patients planned for LAAC with the FLX device underwent ICE-guided implantation with conscious sedation. Transesophageal echocardiography (TEE) imaging was done preprocedure (to assess LAA size and exclude thrombus) and at clinical follow-up at 6-12 weeks. Clinical outcomes were LAA closure success, complications, leak, or DRT on follow-up TEE and major safety events., Results: The study included 30 patients: age 75 ± 8 years, 53% men, CHA 2 DS 2 -VASc 4.6 ± 1.6, and HAS-BLED 3.4 ± 1.1. The primary indication was prior bleeding in 60% (72% GI bleeding). The LAA orifice width and length were 22.7 ± 3.1 and 25.7 ± 5.7 mm, respectively. Technical success was 100% (the first-choice device was used in 28 of 30). Procedure time was less than 30 min in 27 of 30 cases, with 36 ± 15 ml contrast used. The final device size was 29.2 ± 4.7 mm with 21.6 ± 4.5% compression. There were no procedure-related complications. Follow-up TEE at a median 47 days follow-up showed 100% device success with no DRT or peridevice leak ≥5 mm. Major safety events occurred in 6.6% (2/30)., Conclusion: The Watchman FLX device can be safely implanted with intraprocedural ICE imaging instead of TEE., (© 2021 Wiley Periodicals LLC.)

Transradial access (TRA) has emerged as an alternative to transfemoral access (TFA) for percutaneous coronary intervention (PCI) in ST elevation myocardial infarction (STEMI) patients. However, the rate of TRA adoption has been much slower in the acute coronary syndrome (ACS) patient population. This meta-analysis was conducted to assess clinical outcomes of TRA compared with TFA in STEMI patients undergoing PCI. A manual search of PubMed, EMBASE, Cochrane library database, Cumulative Index to Nursing and Allied Health Literature (CINAHL), ClinicalTrials.gov, and recent major scientific conference sessions from inception to October 15th, 2019 was performed. Primary outcomes in our analysis were all-cause mortality and trial-defined major bleeding. Secondary outcomes included vascular complications, myocardial infarction, stroke, procedure, and fluoroscopy time. 17 randomized controlled trials (RCTs) (N = 12,018) met inclusion criteria. TRA was associated with lower all-cause mortality (risk ratio [RR]: 0.71, 95% confidence interval [CI]: 0.57 to 0.88), major bleeding (RR: 0.59, 95%CI: 0.45 to 0.77), and vascular complications (RR: 0.42, 95%CI: 0.32 to 0.56) compared with TFA. There was no difference in the incidence of myocardial infarction (MI), stroke, or procedure duration between the 2 groups. The difference in all-cause mortality between TRA and TFA was statistically nonsignificant when major bleeding was held constant. In conclusion, TRA was associated with lower risk of all-cause mortality, major bleeding, and vascular complications compared with TFA in STEMI patients undergoing PCI., Competing Interests: Declaration of Interests The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2020 Elsevier Inc. All rights reserved.)

Objectives: This study sought to determine the impact of adjunctive renal sympathetic denervation to catheter ablation in patients with atrial fibrillation (AF) and history of hypertension., Background: There are limited data regarding the impact of upstream adjunctive renal sympathetic denervation (RSDN) to pulmonary vein isolation (PVI) in patients with symptomatic atrial fibrillation (AF) and hypertension., Methods: The data for this study were obtained from 2 prospective randomized pilot studies, the HFIB (Adjunctive Renal Denervation to Modify Hypertension and Sympathetic tone as Upstream Therapy in the Treatment of Atrial Fibrillation)-1 (n = 30) and HFIB (Adjunctive Renal Denervation to Modify Hypertension and Sympathetic tone as Upstream Therapy in the Treatment of Atrial Fibrillation)-2 (n = 50) studies, and we performed a meta-analysis including all published studies comparing RSDN+PVI versus PVI alone up to January 25, 2020, in patients with AF and hypertension., Results: At 24 months, AF recurrence occurred in 53% and 38% in the PVI and PVI+RSDN groups (p = 0.43) in the HFIB-1 study, respectively, and 27% and 25% in the PVI and PVI+RSDN groups (p = 0.80) in the HFIB-2 study, respectively. When combined in a meta-analysis including 6 studies (n = 725), adjunctive RSDN significantly decreased the risk of AF recurrence (risk ratio [RR]: 0.68; 95% confidence interval [CI]: 0.55 to 0.83; p = 0.0002; I 2  = 0%) when compared with PVI. Six renal artery complications occurred in the HFIB-1 study and none occurred in the HFIB-2 study with RSDN. However, in the meta-analysis, there were no significant differences in overall complications between both groups (RR: 1.43; 95% CI: 0.63 to 3.22; p = 0.40; I 2  = 7%). When compared with baseline, RDSN significantly reduced the systolic blood pressure (-12.1 mm Hg; 95% CI: -20.9 to -3.3 mm Hg; p < 0.007; I 2  = 99%) and diastolic blood pressure (-5.60 mm Hg; 95% CI: -10.05 to -1.10 mm Hg; p = 0.01; I 2  = 98%) on follow-up., Conclusions: The pilot HFIB-1 and HFIB-2 studies did not demonstrate a benefit with RSDN as an adjunctive upstream therapy during PVI. However, in the meta-analysis, adjunctive RSDN to PVI appears to be safe, and improves clinical outcomes in AF patients with a history of hypertension., Competing Interests: Author Disclosures The HFIB-1 study was sponsored by Biosense Webster. The HFIB-2 study was sponsored by Boston Scientific. Dr. Cuoco has served as a consultant for St. Jude Medical and Boston Scientific. Dr. Mansour has received research grant support from Abbott, Biosense Webster, Johnson and Johnson, Boston Scientific, Medtronic, Pfizer, Boehringer Ingelheim, and Sentre Heart; has served as a consultant for Abbott, Biosense Webster, Jonhson and Johnson, Boston Scientific, Janssen, Medtronic, Philips, Novartis, and Sentre Heart; and owns equity interest in Affera, EPS Solutions, and NewPace Ltd. Dr. Lakkireddy has served as a steering committee member for the Amulet and Amaze IDE studies; and received consulting fees from Abbott. Dr. Michaud has served as a consultant for Biosense Webster, Boston Scientific, and Abbott; and has received honoraria from Biosense Webster, Boston Scientific, Biotronik, Medtronic, and Abbott. Dr. Dukkipati owns equity interest in Manual Surgical Sciences and Farapulse; and has received research grant support from Biosense Webster. Dr. Reddy has served as an unpaid consultant to and received grant support from Biosense Webster and Boston Scientific. Additional disclosures unrelated to this manuscript are listed in the Supplemental Appendix. 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.)

Intracardiac echocardiography (ICE) has emerged as an alternative to transesophageal echocardiography (TEE) to guide implantation of percutaneous left atrial appendage closure (LAAC) devices in patients with atrial fibrillation (AF) and a high bleeding risk. We reviewed the efficacy and safety of ICE compared to TEE in LAAC in this updated meta-analysis. Medline, CINAHL, EMBASE and Scopus were systematically searched for studies comparing ICE and TEE in percutaneous LAAC. Our primary outcomes of interest were procedural success and study reported periprocedural complications. Secondary outcomes included various procedural characteristics. Risk ratios (RR), standardized mean differences (SMD) and their corresponding 95% confidence intervals (CI) were calculated. The analysis was performed using a random-effect model. Nine observational studies met our inclusion criteria with a total of 2620 patients (ICE: 679 and TEE: 1941). Mean CHA 2 DS 2 -Vasc (4.4 ± 0.3 for ICE vs 4.5 ± 0.3 for TEE, P = 0.60) and HAS-BLED (3.2 ± 0.4 vs 3.1 ± 0.6, P = 0.78) scores were comparable between the two groups. There was no significant difference in procedure success rate (RR: 1.01, 95% CI: 0.99-1.02, P= 0.31) and periprocedural complications (RR: 0.85, 95% CI: 0.59-1.23, P = 0.39). No significant difference was observed in procedure duration, fluoroscopy time and contrast volume used while a trend towards decreased hospital length of stay was seen with the use of ICE. Thus, our updated meta-analysis shows ICE is as effective and safe as TEE for implantation of LAAC devices., Competing Interests: Dr. Pradeep Yadav: Consultant for Edwards Lifesciences, Abbott Vascular, Shockwave Medical, Stock options Shockwave Medical. Dr. J Dawn Abbott: Research grants with no direct compensation from Abbott vascular, Sinomed, Astrazeneca, Bristol myers squibb, Biosensors Research USA Inc. Dr. Dhanunjaya Lakkireddy: Has served as a steering committee member for the Amulet and Amaze IDE studies; and has received consulting fees from Abbott. Dr. Manish Parikh: Advisory board and speaker bureau for Medtronic, Boston Scientific and Abbott Vascular. Dr. Poonam Velagapudi: Speakers bureau, Abiomed., (AJCD Copyright © 2020.)

Introduction: Implantable cardioverter-defibrillator (ICD) in patients with heart failure with reduced ejection fraction reduces mortality secondary to malignant arrhythmias. Whether cardiac transplant patients considered high risk for sudden death (SD) derive similar benefits remains controversial., Methods: Systematic search, without language restriction, using PubMed, EMBASE, SCOPUS, Google Scholar, and ClinicalTrials.gov was performed from inception to June 4, 2020, for studies that had reported outcomes in patients who had ICD implanted after cardiac transplant. The outcomes studied were as follows: (a) SD and (b) appropriate and inappropriate ICD therapies., Results: Seven studies (from 1983 through 2018) with a total of 338 cardiac transplant patients who received ICD met study inclusion criteria. The mean age was 48.37 ± 14.85 years, and 70.4% were men. The pooled incidence of SD was 16.3% (95% CI 6.2-29.0%; I 2   = 66%). Appropriate and inappropriate ICD therapies were observed in 12.1% (95% CI 5.3-20.4; I 2   = 0%) and 3.5% (95% CI 0.11-9.58%; I 2   = 0%), respectively during the follow-up period (27.48 ± 24.27 months). The most common cause for SD was heart failure (15.6%), followed by electromechanical disassociation, malignant ventricular arrhythmias (4.7% each, respectively), and cardiac allograft vasculopathy (CAV) (3.1%). Furthermore, approximately 60% (10/17) of patients with appropriate ICD shocks had CAV., Conclusion: Despite, low incidence of arrhythmic mortality, there remains an increased burden of ventricular arrhythmias, as evident by a 12% appropriate ICD shock rates, suggesting ICD might be a practical decision in selected cardiac transplant patients deemed high risk of SD (i.e., patients with advanced CAV and left ventricular systolic dysfunction)., (© 2020 Wiley Periodicals LLC.)

Background: Patients with coronavirus disease 2019 (COVID-19) who develop cardiac injury are reported to experience higher rates of malignant cardiac arrhythmias. However, little is known about these arrhythmias-their frequency, the underlying mechanisms, and their impact on mortality., Methods: We extracted data from a registry (NCT04358029) regarding consecutive inpatients with confirmed COVID-19 who were receiving continuous telemetric ECG monitoring and had a definitive disposition of hospital discharge or death. Between patients who died versus discharged, we compared a primary composite end point of cardiac arrest from ventricular tachycardia/fibrillation or bradyarrhythmias such as atrioventricular block., Results: Among 800 patients with COVID-19 at Mount Sinai Hospital with definitive dispositions, 140 patients had telemetric monitoring, and either died (52) or were discharged (88). The median (interquartile range) age was 61 years (48-74); 73% men; and ethnicity was White in 34%. Comorbidities included hypertension in 61%, coronary artery disease in 25%, ventricular arrhythmia history in 1.4%, and no significant comorbidities in 16%. Compared with discharged patients, those who died had elevated peak troponin I levels (0.27 versus 0.02 ng/mL) and more primary end point events (17% versus 4%, P =0.01)-a difference driven by tachyarrhythmias. Fatal tachyarrhythmias invariably occurred in the presence of severe metabolic imbalance, while atrioventricular block was largely an independent primary event., Conclusions: Hospitalized patients with COVID-19 who die experience malignant cardiac arrhythmias more often than those surviving to discharge. However, these events represent a minority of cardiovascular deaths, and ventricular tachyarrhythmias are mainly associated with severe metabolic derangement. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT04358029.

The 2019 novel coronavirus, declared a pandemic, has infected 2.6 million people as of April 27, 2020, and has resulted in the death of 181,938 people. D-dimer is an important prognostic tool, is often elevated in patients with severe coronavirus disease-19 (COVID-19) infection and in those who suffered death. In this systematic review, we aimed to investigate the prognostic role of D-dimer in COVID-19-infected patients. We searched PubMed, Medline, Embase, Ovid, and Cochrane for studies reporting admission D-dimer levels in COVID-19 patients and its effect on mortality. Eighteen studies (16 retrospective and 2 prospective) with a total of 3682 patients met the inclusion criteria. The pooled weighted mean difference (WMD) demonstrated significantly elevated D-dimer levels in patients who died versus those who survived (WMD, 6.13 mg/L; 95% confidence interval [CI] 4.16-8.11; P < 0.001). Similarly, the pooled mean D-dimer levels were significantly elevated in patients with severe COVID-19 infection (WMD, 0.54 mg/L; 95% CI 0.28-0.80; P < 0.001). The risk of mortality was fourfold higher in patients with positive D-dimer versus negative D-dimer (risk ratio, 4.11; 95% CI, 2.48-6.84; P < 0.001) and the risk of developing severe disease was twofold higher in patients with positive D-dimer levels versus negative D-dimer (risk ratio, 2.04; 95% CI, 1.34-3.11; P < 0.001). Our meta-analysis demonstrates that patients with COVID-19 infection presenting with elevated D-dimer levels have an increased risk of severe disease and mortality.

Introduction: Recent studies have described several cardiovascular manifestations of COVID-19 including myocardial ischemia, myocarditis, thromboembolism, and malignant arrhythmias. However, to our knowledge, syncope in COVID-19 patients has not been systematically evaluated. We sought to characterize syncope and/or presyncope in COVID-19., Methods: This is a retrospective analysis of consecutive patients hospitalized with laboratory-confirmed COVID-19 with either syncope or presyncope. This "study" group (n = 37) was compared with an age and gender-matched cohort of patients without syncope ("control") (n = 40). Syncope was attributed to various categories. We compared telemetry data, treatments received, and clinical outcomes between the two groups., Results: Among 1000 COVID-19 patients admitted to the Mount Sinai Hospital, the incidence of syncope/presyncope was 3.7%. The median age of the entire cohort was 69 years (range 26-89+ years) and 55% were men. Major comorbidities included hypertension, diabetes, and coronary artery disease. Syncopal episodes were categorized as (a) unspecified in 59.4% patients, (b) neurocardiogenic in 15.6% patients, (c) hypotensive in 12.5% patients, and (d) cardiopulmonary in 3.1% patients with fall versus syncope and seizure versus syncope in 2 of 32 (6.3%) and 1 of 33 (3.1%) patients, respectively. Compared with the "control" group, there were no significant differences in both admission and peak blood levels of d-dimer, troponin-I, and CRP in the "study" group. Additionally, there were no differences in arrhythmias or death between both groups., Conclusions: Syncope/presyncope in patients hospitalized with COVID-19 is uncommon and is infrequently associated with a cardiac etiology or associated with adverse outcomes compared to those who do not present with these symptoms., (© 2020 Wiley Periodicals LLC.)

Purpose of Review: In patients with atrial fibrillation who are unable to take novel oral anticoagulants for stroke prophylaxis due to bleeding risk or other contraindications, left atrial appendage (LAA) occlusion and exclusion devices have shown benefit. In this review, we highlight the risks and benefits associated with LAA removal., Recent Findings: LAA, once considered a vestigial organ, has been shown to have physiological, anatomical, and arrhythmogenic properties. Device-related complications such as pericardial effusion, device embolization, device-related thrombus, while uncommon, are still present. With increased operator experience related to appendage occlusion, overall procedural complications have declined. Further refinements in device technology will help decrease complications. While benefits of appendage removal are plenty, procedural complications need to be weighed into the equation when making decisions regarding LAA occlusion.

Background: Pulmonary vein (PV) stenosis is an important potential complication of PV isolation using thermal modalities such as radiofrequency ablation (RFA). Pulsed field ablation (PFA) is an alternative energy that causes nonthermal myocardial cell death., Objective: The purpose of this study was to compare the effect of PFA vs RFA on the incidence and severity of PV narrowing or stenosis., Methods: Data were analyzed from 4 paroxysmal atrial fibrillation ablation trials using either PFA or RFA; because of absent CT scans or poor computed tomography scan quality, 73 of 153 patients (47.7%) were excluded. Baseline and 3-month cardiac computed tomography scans were reconstructed into 3-dimensional images, and the long and short axes of the PV ostia were quantitatively and qualitatively assessed in a randomized blinded manner by 2 physicians., Results: A total of 299 PVs from 80 patients after either PFA (n = 37) or RFA (n = 43) were enrolled. PV ostial diameters decreased significantly less with PFA than with RFA (% change; long axis: 0.9% ± 8.5% vs -11.9% ± 16.3%; P < .001 and short axis: 3.4% ± 12.7% vs -12.9% ± 18.5%; P < .001). After a combined quantitative/qualitative analysis, mild (30%-49%), moderate (50%-69%), or severe (70%-100%) PV narrowing was observed, respectively, in 9.0% (15 of 166), 1.8% (3 of 166), and 1.2% (2 of 166) of PVs in the RFA cohort but in none of the PVs after PFA (P < .001). Overall, PV narrowing/stenosis was present in 0% and 0% vs 12.0% and 32.5% of PVs and patients who underwent PFA and RFA, respectively., Conclusion: This study indicates that unlike after RFA, the incidence and severity of PV narrowing/stenosis after PV isolation is virtually eliminated with PFA., (Copyright © 2020 The Authors. Published by Elsevier Inc. All rights reserved.)

Introduction: Transseptal puncture (TSP) is challenging in patients with prior percutaneous atrial septal defect (ASD) occluder. We aimed to perform a systematic review and meta-analysis of the safety and efficacy of catheter ablation for atrial fibrillation (AF) in patients with percutaneous ASD occluder., Methods: We searched PubMed, Medline, Embase, Ovid, and Cochrane for studies reporting results of AF ablation (freedom from AF, fluoroscopy/procedure time, and complications) in patients with percutaneous ASD occluders., Results: Three studies with a total of 64 patients met inclusion criteria. The success rate of TSP was 100%. All patients (but one) underwent TSP under fluoroscopic and intracardiac echocardiography guidance. Freedom from AF was achieved in 77.7% (95% confidence interval [CI]: 65.7-86.3) patients. In the subgroup analysis, comparing septal versus device puncture, no significant difference in recurrence of AF was observed (23.07% vs. 16.66%; risk ratio: 1.18; 95% CI: 0.35-4.00; p = .79, respectively). The total fluoroscopy time was not significantly different in patients with TSP via native septum or device (43.50 vs. 70.67 min; p = .44), total procedural time was significantly longer with TSP via the closure device (237.3 vs. 180 min; p = .004) compared with the native septum. There were no device dislodgement or residual interatrial shunt during the follow-up period., Conclusion: Catheter ablation for AF in patients with prior percutaneous ASD closure device is feasible and safe with favorable long-term outcomes., (© 2020 Wiley Periodicals LLC.)

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.)

Purpose: Cardiac sarcoidosis is a multisystem inflammatory disorder characterized by ventricular arrhythmias. Implantable cardioverter defibrillator (ICD) is used to prevent sudden cardiac death., Methods: We performed literature search for studies that addressed the outcome and complications of ICD in Cardiac Sarcoidosis (CS). Multiple search sites were reviewed from January 1, 2000 until December 1, 2018. We then performed a meta-analysis using a random effects model. Two investigators independently extracted the data and assessed studies' quality., Results: Ten studies with 585 patients qualified for the analysis. In the pooled analysis, 57% were male with mean left ventricular ejection fraction (LVEF) of 38.4%. Appropriate and inappropriate ICD treatments (AT and IAT) were reported in 39% and 15% of patients respectively over mean follow-up period of 25 months and mortality rate of 8%. A sub-analysis of four studies indicated that patients with appropriate therapy did not differ from the rest of CS population in LVEF% (mean difference (MD) = - 7.37%, 95% confidence interval (CI) - 16.89 to 2.15, p = 0.12), age (MD = - 3.87 years, 95% CI - 10.19 to 2.46, p = 0.23), primary prevention (range difference (RD) = - 0.11, 95% CI - 0.31 to 0.10, p = 0.31) or secondary prevention indication (RD = 0.09, 95% CI - 0.12 to 0.3, p = 0.37). High degree AV block was more common in patients with AT (RD = 0.07, 95% CI 0.00 to 0.14 p = 0.05)., Conclusions: ICD placement in CS is associated with high incidence of both appropriate and inappropriate therapy. High degree AV block appears to be predictive of appropriate ICD therapy.

Background: Cardiac sympathetic denervation (CSD) is being used in the management of refractory ventricular tachycardia (VT) and electrical storm. However, data on the role of CSD in the management of ventricular arrhythmia is limited., Methods: We performed a meta-analysis of retrospective studies to calculate the pooled rate of freedom from VT and the standard mean difference of ICD shocks before and after CSD., Results: 14 nonrandomized studies with a total of 311 patients with refractory VT or electrical storm were included. At a mean follow up of 15 ± 10.7 months, the pooled rate of freedom from VT (VT nonrecurrence rate) after CSD in all causes of arrhythmia was 60% (range 48.8% to 70%, I 2   = 43%). When analysis was restricted to only arrhythmias caused by conditions other than catecholaminergic polymorphic ventricular tachycardia (CPVT) and long QT syndrome (LQTS), the pooled VT non-recurrence rate was 50% (range 41% to 58%, I 2   = 5%). After CSD, mean total number of ICD shocks per person diminished by 3.01 (95% CI 1.09-4.94, P = .002, I 2  = 96%) in overall analysis and by 0.97(95% CI 0.41-1.5, P = .001, I 2  = 45%) when CPVT and LQTS were excluded., Conclusion: In patients with refractory VT or electrical storm, CSD is associated with pooled VT nonrecurrence rate of 60% at a mean follow-up of 15 ± 10.7 months. CSD was also associated with significantly lower mean number ICD shocks per person. Further studies are needed to validate this finding in a prospective setting., (© 2020 Wiley Periodicals LLC.)

Objectives: The goal of this systematic review and meta-analysis was to provide a comprehensive evaluation of contemporary randomized trials addressing the efficacy and safety of multivessel versus culprit vessel-only percutaneous coronary intervention (PCI) among patients presenting with ST-segment elevation myocardial infarction and multivessel coronary artery disease., Background: Multivessel coronary artery disease is present in about one-half of patients with ST-segment elevation myocardial infarction. Randomized controlled trials comparing multivessel and culprit vessel-only PCI produced conflicting results regarding the benefits of a multivessel PCI strategy., Methods: A comprehensive search for published randomized controlled trials comparing multivessel PCI with culprit vessel-only PCI was conducted on ClinicalTrials.gov, PubMed, Web of Science, EBSCO Services, the Cochrane Central Register of Controlled Trials, Google Scholar, and scientific conference sessions from inception to September 15, 2019. A meta-analysis was performed using a random-effects model to calculate the risk ratio (RR) and 95% confidence interval (CI). Primary efficacy outcomes were all-cause mortality and reinfarction., Results: Ten randomized controlled trials were included, representing 7,030 patients: 3,426 underwent multivessel PCI and 3,604 received culprit vessel-only PCI. Compared with culprit vessel-only PCI, multivessel PCI was associated with no significant difference in all-cause mortality (RR: 0.85; 95% CI: 0.68 to 1.05) and lower risk for reinfarction (RR: 0.69; 95% CI: 0.50 to 0.95), cardiovascular mortality (RR: 0.71; 95% CI: 0.50 to 1.00), and repeat revascularization (RR: 0.34; 95% CI: 0.25 to 0.44). Major bleeding (RR: 0.92; 95% CI: 0.50 to 1.67), stroke (RR: 1.15; 95% CI: 0.65 to 2.01), and contrast-induced nephropathy (RR: 1.25; 95% CI: 0.80 to 1.95) were not significantly different between the 2 groups., Conclusions: Multivessel PCI was associated with a lower risk for reinfarction, without any difference in all-cause mortality, compared with culprit vessel-only PCI in patients with ST-segment elevation myocardial infarction., (Copyright © 2020 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Introduction: Novel oral anticoagulants (NOACs) are commonly used for thromboembolic risk reduction and treatment of pulmonary embolism and deep venous thrombosis. However, data regarding their efficacy and safety in comparison to warfarin for left atrial appendage thrombus is limited., Methods: A comprehensive literature search in PubMed, Google Scholar, and Cochrane Review from inception to 30 October 2019 was performed. Studies reporting clinical outcomes comparing warfarin vs NOACs were included. Two investigators independently extracted the data and individual quality assessment was performed. A meta-analysis was performed using random-effects model to calculate risk ratio (RR) and 95% confidence interval (CI). The analysis was performed using RevMan 5.3., Results: Four studies met inclusion criteria and a total of 322 patients were included of whom 141 were in the NOAC arm and 181 were in the warfarin arm. There was no significant difference in thrombus resolution between the two groups (RR, 1.00; 95% CI [0.77-1.29; P = .98]). There was no significant difference in major bleeding (RR, 1.30; 95% CI [0.14-12.21; P = .82]) or stroke (RR, 0.42; 95% CI [0.09-2.06; P = .29]) between the two groups., Conclusion: The results of our meta-analysis show that NOACs are as efficacious and safe as warfarin in the treatment of left atrial appendage thrombus in patients with non-valvular atrial fibrillation., (© 2020 Wiley Periodicals, Inc.)

Background: Electrophysiological procedures such as epicardial ventricular tachycardia ablation and Lariat left atrial appendage ligation that involve the epicardial space are typically associated with significant postoperative pain due to mechanical irritation and associated inflammation. There is an unmet need for an effective pain management strategy in this group of patients. We studied how this impacts patient comfort and duration of hospitalization and other associated comorbidities related to pericardial access., Methods: This is a multicenter retrospective study including 104 patients who underwent epicardial ventricular tachycardia ablation and Lariat left atrial appendage exclusion. We compared 53 patients who received postprocedural intrapericardial liposomal bupivacaine (LB)+oral colchicine (LB group) and 51 patients who received colchicine alone (non-LB group) between January 2015 and March 2018., Results: LB was associated with significant lowering of median pain scale at 6 hours (1.0 [0-2.0] versus 8.0 [6.0-8.0], P <0.001), 12 hours (1.0 [1.0-2.0] versus 6.0 [5.0-6.0], P <0.001), and up to 48 hours postprocedure. Incidence of acute severe pericarditis delayed pericardial effusion and gastrointestinal adverse effects were similar in both groups. Median length of stay was significantly lower in LB group (2.0 versus 3.0; adjusted linear coefficient -1 [CI -1.3 to -0.6], P <0.001). Subgroup analysis demonstrated similar favorable outcomes in both Lariat and epicardial ventricular tachycardia ablation groups., Conclusions: Addition of intrapericardial postprocedural LB to oral colchicine in patients undergoing epicardial access during ventricular tachycardia ablation or Lariat procedure is associated with significantly decreased numeric pain score up to 48 hours compared with colchicine alone. It is also associated with significantly shorter length of hospital stay without an increase in the risk of adverse events.

Introduction: Pulmonary vein isolation (PVI) using standard radiofrequency (RF) catheters is limited by incomplete contiguity and prolonged procedural times. A novel, 9-mm lattice-tip irrigated RF catheter can create wide lesions rapidly in swine atria., Methods: In five swine, temperature limited (75°C) irrigated RF for 5 seconds/ablation was selected, to isolate seven pulmonary veins (PVs; five right superior and two inferior commons) and create five right atrial lines. After 4 weeks, repeat mapping and additional ablation to create atrial isthmus lesions were performed. The chronic lesions were submitted for histology. This was compared with right superior PVI data using standard 3.5-mm irrigated tip ablation in six swine., Results: All targeted PVs (seven of seven, 100%) were acutely isolated. Durable isolation was observed in all six of six PVs treated with 5-second applications, but not in one PV inadvertently treated with 4-second applications. For the durably isolated PVs, the mean lesion count/PV and total RF time/PV was 16.3 ± 5.2 applications and 81.3 ± 25.9 seconds for the right superior and 14.5 ± 0.7 applications and 71.1 ± 5.5 seconds for the inferior common PV. Right atrial linear ablation was performed with a lesion count of 12 ± 2.3 applications and RF times of 59.5 ± 12.5 seconds. Cavotricuspid and mitral isthmus linear ablations were transmural along their entire length. All 53 of 53 (100%) sections were transmural on histology., Conclusion: Rapid and durable PVI and linear atrial ablation is feasible with this novel 9-mm lattice-tip catheter., (© 2020 Wiley Periodicals, Inc.)

Objectives: This study sought to evaluate the efficacy and safety of venous access techniques for cardiac implantable electronic device (CIED) implantation., Background: Minimally invasive transvenous access is a fundamental step during implantation of CIEDs. However, the preferred venous access is still subject to ongoing debate, and the decision depends on patient characteristics and operator experience., Methods: A comprehensive search for studies comparing subclavian vein puncture (SVP) and axillary vein puncture (AVP) versus cephalic vein cutdown (CVC) for CIED implantation was performed in PubMed, Google Scholar, EMBASE, SCOPUS, ClinicalTrials.gov, and various scientific conferences from inception to July 1, 2019. A meta-analysis was performed by using a random effects model to calculate risk ratios (RRs) and mean differences with 95% confidence interval (CIs)., Results: Twenty-three studies were eligible that included 35,722 patients (SVP, n = 18,009; AVP, n = 409; and CVC, n = 17,304). Compared with CVC, SVP was associated with a higher risk of pneumothorax (RR: 4.88; 95% CI: 2.95 to 8.06) and device/lead failure (RR: 2.09; 95% CI: 1.07 to 4.09), whereas there was no significant difference in these outcomes compared with AVP. Acute procedural success was significantly higher with SVP compared with CVC (RR: 1.24; 95% CI: 1.00 to 1.53). There was no significant difference in other complications such as pocket hematoma/bleeding, device infection, or pericardial effusion between SVP or AVP compared with CVC., Conclusions: CVC was associated with a lower risk of pneumothorax and lead failure compared with SVP. AVP and CVC are both effective approaches for CIED lead implantation and offer the potential to avoid the complications usually observed with traditional SVP., (Copyright © 2020 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

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: Vascular hemostasis after venous access in cardiovascular procedures remains a challenge. Figure-of-eight (FoE) emerged as an alternative technique to manual pressure. However, its feasibility and safety is unknown., Methods: A comprehensive search 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 December 1, 2018, was performed. A meta-analysis was performed using random effects model to calculate risk ratio (RR) and mean difference (MD) with 95% confidence interval (CI)., Results: Seven studies were eligible and included 1978 patients, of whom 982 patients received the FoE suture, while 996 received manual pressure. There was no difference in the risk of access site pseudoaneurysm (RR 0.48, 95%CI 0.13 to 1.73, p = 0.26) and fistula (RR 0.90, 95%CI 0.22 to 3.75, p = 0.89) between the two techniques. Compared with manual pressure, FoE was associated with lower risk of access site complications (RR 0.37, 95%CI 0.24 to 0.58, 0.65, p < 0.0001) including bleeding (RR 0.30, 95%CI 0.18 to 0.50, p < 0.00001) and hematoma (RR 0.41, 95%CI 0.25 to 0.68, 0.83, p = 0.0005). Time to hemostasis was significantly lower in FoE group compared with manual pressure (MD - 21.04 min, 95%CI - 35.66 to - 6.42, p = 0.005)., Conclusions: The results of our meta-analysis showed that there was no difference in the risk of access site pseudoaneurysm and fistula between FoE and manual pressure. FoE was associated with lower risk of access site hematoma and bleeding compared with manual pressure. Our results reiterate the safety and feasibility of FoE suture for venous access closure.

Objectives: This study sought to evaluate the safety and feasibility of percutaneous retrieval of left atrial appendage closure (LAAC) devices with an endoscopic grasping tool., Background: Transcatheter LAAC is a mechanical stroke prevention strategy in patients with nonvalvular atrial fibrillation (AF) who are poor candidates for long-term oral anticoagulation. However, these LAAC devices can be inadvertently released into an unfavorable location, the device might migrate to a different (unfavorable) position within the left atrial appendage (LAA) or may embolize from the heart into the aorta. In such instances, it can be challenging to remove the LAAC device without open cardiac or vascular surgery., Methods: This study reports on a series of 4 cases in which an endoscopic grasping tool (Raptor) designed for gastrointestinal applications was used to percutaneously (non-surgically) remove LAAC devices that were either malpositioned or embolized., Results: LAAC devices were safely and non-surgically removed using the grasping device in all 4 cases (Amulet: 1, Watchman: 3). Devices were successfully retrieved from the left inferior pulmonary vein, descending aorta, aortic arch, and the edge of the LAA ostium. Time of device retrieval post-LAAC implantation ranged from 24 h to 1 year. Special precautionary measures, such as preemptive pericardial access, embolic protection devices, and intraprocedural imaging, were used in 2 cases., Conclusions: This case series demonstrated that the endoscopic grasping tool appeared to be safe and useful to percutaneously retrieve LAAC devices., (Copyright © 2020 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background: Catheter ablation for atrial fibrillation (AF) using point-by-point radiofrequency energy or single-application one-shot balloons is either technically challenging or have limited ability to accommodate variable patient anatomy to achieve acute and durable pulmonary vein (PV) isolation. A novel ablation system employs low intensity collimated ultrasound (LICU)-guided anatomic mapping and robotic ablation to isolate PVs. In this first-in-human, single-center, multioperator trial, VALUE trial (VytronUS Ablation System for Treatment of Paroxysmal Atrial Fibrillation; NCT03639597) in patients with paroxysmal atrial fibrillation, this LICU system was evaluated to determine its safety, effectiveness in PV isolation, and freedom from recurrent atrial arrhythmias., Methods: In the enrolled 52 patients with paroxysmal atrial fibrillation, ultrasound M-mode-based left atrial anatomies were successfully created, and ablation was performed under robotic control along an operator-defined lesion path. The LICU system software advanced over the course of the study: the last 13 patients were ablated with enhanced software., Results: Acute PV isolation was achieved in 98% of PVs-using LICU-only in 77.3% (153/198) of PVs and requiring touch-up with a standard radiofrequency ablation catheter in 22.7% (45/198) PVs. The touch-up rate decreased to 5.8% (3/52) in patients undergoing LICU-ablation with enhanced software. Freedom from atrial arrhythmia recurrence was 79.6% (39/49 patients) at 12 months or 92.3% (12/13 patients) with the enhanced software. Major adverse events occurred in 3 patients (5.8%): one had transient diaphragmatic paralysis, one vascular access complication, and one had transient ST-segment elevation from air-embolism, without sequelae., Conclusions: In this first-in-human study, low- intensity collimated ultrasound-guided anatomic mapping and robotic ablation allows PV isolation with good chronic safety; PV isolation success is improving with device enhancements. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT03639597.

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.)

Premature ventricular complexes (PVCs) are common arrhythmias in the clinical setting. PVCs in the structurally normal heart are usually benign, but in the presence of structural heart disease (SHD), they may indicate increased risk of sudden death. High PVC burden may induce cardiomyopathy and left ventricular (LV) dysfunction or worsen underlying cardiomyopathy. Sometimes PVCs may be a marker of underlying pathophysiologic process such as myocarditis. Identification of PVC burden is important, since cardiomyopathy and LV dysfunction can reverse after catheter ablation or pharmacological suppression. This state-of-the-art review discusses pathophysiology, clinical manifestations, how to differentiate benign and malignant PVCs, PVCs in the structurally normal heart, underlying SHD, diagnostic procedures (physical examination, electrocardiogram, ambulatory monitoring, exercise testing, echocardiography, cardiac magnetic resonance imaging, coronary angiography, electrophysiology study), and treatment (lifestyle modification, electrolyte imbalance, medical, and catheter ablation).

Background: Premature ventricular contractions are a common clinical presentation that drives further diagnostic workup. We hypothesize the presence of underlying inflammation is often unrecognized in these patients with a potential for continued disease progression if not diagnosed and treated early in the disease course., Methods: This is a single-center, prospective study including 107 patients with frequent symptomatic premature ventricular contractions (>5000/24 h) and no known ischemic heart disease. Patients underwent a combination of laboratory testing, 18F-fluorodeoxyglucose positron emission tomography scan, cardiac magnetic resonance imaging, and biopsy. Patients were diagnosed with myocarditis based on a multidisciplinary approach and treated with immunosuppressive therapy., Results: The mean age of the cohort was 57±15 years, 41% were males, and left ventricular ejection fraction was 47±11.8%. Positive positron emission tomography scan was seen in 51% (55/107), of which 51% (28/55) had preserved left ventricle function. Based on clinical profile, 18F-fluorodeoxyglucose-positron emission tomography imaging, cardiac magnetic resonance, and histological data 58% patients (32/55) received immunosuppressive therapy alone and 25.4% (14/55) received immunosuppressive therapy and catheter ablation. Optimal response was seen in 67% (31/46) over a mean follow-up of 6±3 months. In patients with left ventricle systolic dysfunction, 37% (10/27) showed an improvement in mean left ventricular ejection fraction of 13±6%., Conclusions: Approximately 51% of patients presenting with frequent premature ventricular contractions have underlying myocardial inflammation in this cohort. 18F-fluorodeoxyglucose-positron emission tomography scan can be a useful modality for early diagnosis and treatment with immunosuppressive therapy in selected patients can improve clinical outcomes.

Background: Left atrial appendage closure (LAAC) with LARIAT has emerged as one of the alternatives to oral anticoagulation (OAC) in patients with nonvalvular atrial fibrillation (AF). Our aim was to study long-term outcomes in patients undergoing LARIAT procedure., Methods: We analyzed patients screened for LARIAT device in four centers between December 2009 and June 2012. Out of these, patients who didn't undergo LAAC with the LARIAT device due to unfavorable LAA morphology and other preprocedural contraindications were included in control group. We analyzed thromboembolism, bleeding events, and mortality between LAA and control group., Results: About 153 patients were screened. Out of these, 108 (70.6%) patients underwent LARIAT placement (LAA arm) and 45 (29.4%) excluded patients were included in control arm. There were no differences in CHADS 2 and CHA 2 DS 2 -VASc score. Mean HAS-BLED score was significantly higher in the LARIAT group (3.5 ± 1.06 vs 3.09 ± 1.22, P = .04). Mean follow-up time (in years) was 6.56 ± 0.84 in LAA and 6.5 ± 1.26 in control arm. During follow-up period, the LARIAT group was associated with significantly less thromboembolic events (1.9% vs 24%, P < .001), bleeding events (9.2% vs 24.4%, P = .03), and mortality (5.6% vs 20%, P = .01) as compared with the control group., Conclusions: Long-term data from routine clinical practice from our study suggests that LAA exclusion with LARIAT device is an effective treatment in management of nonvalvular AF patients with high risk of stroke, bleeding, and mortality. Further randomized trials, such as aMAZE, will provide more insight in this expanding field., (© 2019 Wiley Periodicals, Inc.)

Background: Direct current cardioversion (DCCV) is a common rhythm control strategy in patients with symptomatic atrial fibrillation or flutter. There is no long-term data regarding the safety of DCCV in patients with endocardial left atrial appendage occlusion (LAAO) devices., Objectives: The purpose of this study was to assess the feasibility and safety of DCCV in patients with an LAAO device., Methods: This multicenter retrospective study included 148 patients with an LAAO device who underwent DCCV for symptomatic atrial fibrillation or atrial flutter., Results: The average age of the included patients was 72 ± 7 years and 59% were men. All patients (100%) had a transesophageal echocardiogram prior to DCCV. Device-related thrombus was seen in 2.7%. They were all successfully treated with oral anticoagulation (OAC) and were able to undergo DCCV after 6 to 8 weeks. DCCV restored sinus rhythm in all patients. None of the patients had DCCV-related thromboembolic complications. A total of 22% of patients were newly started on OAC after DCCV. There was no difference in DCCV-related complications between patients treated with or without OAC post-DCCV. Patients receiving OAC post-DCCV were found to undergo cardioversion at an earlier time after implantation (3.6 months [interquartile range (IQR): 0.7 to 8.6 months] vs. 8.6 months [IQR: 2.5 to 13.3 months]; p = 0.003). Three transient ischemic attacks, unrelated to DCCV, were found during follow-up. During a median follow-up of 12.8 months (IQR: 11.8 to 14.2 months), no device or left atrial thrombosis, device dislodgement, or a new device leak were observed. One patient died during follow-up due to noncardiac cause., Conclusions: DCCV is feasible in high-risk AF patients with an LAAO device without the need for oral anticoagulation if pre-procedural transesophageal echocardiography shows good device position, absence of device-related thrombus, and peridevice leak of ≤5 mm. The preliminary results are encouraging, but further large studies are warranted to establish safety., (Copyright © 2019. Published by Elsevier Inc.)