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Background: In the U.S. Food and Drug Administration (FDA) clinical trials of left atrial appendage (LAA) closure, a postimplantation peridevice leak (PDL) of ≤5 mm (PDL≤5) was accepted as sufficient LAA "closure." However, the clinical consequences of these PDLs on subsequent thromboembolism are poorly characterized.Objectives: We sought to assess the impact of PDL≤5 on clinical outcomes after implantation of the Watchman device.Methods: Using combined data from the FDA studies PROTECT-AF (Watchman Left Atrial Appendage System for Embolic Protection in Patients With Atrial Fibrillation), PREVAIL (Evaluation of the Watchman Left Atrial Appendage Closure Device in Patients With Atrial Fibrillation vs Long Term Warfarin Therapy), and CAP2 (Continued Access to PREVAIL), we assessed patients with successful device implantation for PDL by means of protocol-mandated transesophageal echocardiograms (TEEs) at 45 days and 1 year. Five-year outcomes were assessed as a function of the absence or presence of PDL≤5.Results: The cohort included 1,054 patients: mean age 74 ± 8.3 years, 65% male, and CHA2DS2-VASc 4.1 ± 1.4. TEE imaging at 45 days revealed 634 patients (60.2%) without and 404 (38.3%) with PDL≤5, and 1-year TEE revealed 704 patients (71.6%) without and 272 (27.7%) with PDL≤5. The presence of PDL≤5 at 1 year, but not at 45 days, was associated with an increased 5-year risk of ischemic stroke or systemic embolism (adjusted HR: 1.94; 95% CI: 1.15-3.29; P = 0.014), largely driven by an increase in nondisabling stroke (HR: 1.97; 95% CI: 1.03-3.78; P = 0.04), while disabling or fatal stroke rates were similar (HR: 0.69; 95% CI: 0.19-2.46; P = 0.56). PDL≤5 was not associated with an increased risk of cardiovascular or unexplained death (HR: 1.20; P = 0.45) or all-cause death (HR: 0.87; P = 0.42).Conclusions: PDL≤5 at 1 year after percutaneous LAA closure with the Watchman device are associated with increased thromboembolism, driven by increased nondisabling stroke, but similar mortality. (Watchman Left Atrial Appendage System for Embolic Protection in Patients With Atrial Fibrillation [PROTECT-AF; NCT00129545]; Evaluation of the Watchman Left Atrial Appendage Closure Device in Patients With Atrial Fibrillation vs Long Term Warfarin Therapy [PREVAIL; NCT01182441]; Continued Access to PREVAIL [CAP2; NCT01760291]). [ABSTRACT FROM AUTHOR]

Catheter ablation using radiofrequency (RF) energy has been widely used to treat patients with atrial fibrillation (AF). The optimal levels of power and duration to increase the success rate while minimizing complications have not been fully established. Different centers continue to use various power protocols for catheter ablation of AF. Herein, we present a comprehensive review of the impact of power output on efficacy and safety of RF ablation for AF. High‐power short‐duration (HPSD) ablation can be performed safely with similar procedural efficacy as low‐power long‐duration ablation strategy. HPSD ablation has the potential to shorten procedural and RF times and create more durable and localized lesions. [ABSTRACT FROM AUTHOR]

There is an increasing awareness of the association between mitral valve prolapse and sudden cardiac death. There are several clinical risk factors associated with an increased risk of mitral valve prolapse-related sudden cardiac death, most of which can be evaluated with noninvasive diagnostic modalities. For example, characteristic changes on the electrocardiogram (T-wave inversions in the inferior leads), complex ventricular ectopy, a spiked configuration of the lateral annular velocities by echocardiography, and evidence of myocardial fibrosis by cardiac magnetic resonance imaging have all been implicated as markers of risk. Herein, the authors review the reported incidence of sudden death to mitral valve prolapse, the clinical profile of at-risk patients, and the basic components necessary to initiate and perpetuate ventricular arrhythmias (substrate and trigger) as well as potential interventions to consider for those at highest risk. [ABSTRACT FROM AUTHOR]

Background: In patients with atrial fibrillation, left atrial appendage closure with the Watchman device prevents thromboembolism from the left atrial appendage; however, thrombus may form on the left atrial face of the device, and then potentially embolize. Herein, we studied the incidence, predictors, and clinical outcome of device-related thrombus (DRT) using a large series of clinical trial cohorts of patients undergoing Watchman implantation.Methods: We studied the device arms of 4 prospective Food and Drug Administration trials: PROTECT-AF (Watchman Left Atrial Appendage System for Embolic Protection in Patients With Atrial Fibrillation) (n=463); PREVAIL (Evaluation of the Watchman LAA Closure Device in Patients With Atrial Fibrillation Versus Long Term Warfarin Therapy) (n=269); CAP (Continued Access to PROTECT AF registry) (n=566); and CAP2 (Continued Access to PREVAIL registry) (n=578). Surveillance transesophageal echocardiographs were performed at 45 days and 12 months in all patients, and also at 6 months in the randomized control trials. We assessed both the incidence of DRT during these transesophageal echocardiographs (and other unscheduled transesophageal echocardiographs), and clinical outcomes of postprocedure stroke or systemic embolism (SSE) and adjusted for CHA2DS2-VASC and HAS-BLED scores.Results: Of 1739 patients who received an implant (7159 patient-years follow-up; CHA2DS2-VASc=4.0), DRT was seen in 65 patients (3.74%). The rates of SSE with and without DRT were 7.46 and 1.78 per 100 patient-years (adjusted rate ratio, 3.55; 95% confidence interval [CI], 2.18-5.79; P<0.001), and ischemic SSE rates were 6.28 and 1.65 per 100 patient-years (adjusted rate ratio, 3.22; 95% CI, 1.90-5.45, P<0.001). On multivariable modeling analysis, the predictors of DRT were as follows: history of transient ischemic attack or stroke (odds ratio [OR], 2.31; 95% CI, 1.26-4.25; P=0.007), permanent atrial fibrillation (OR, 2.24; 95% CI, 1.19-4.20; P=0.012); vascular disease (OR, 2.06; 95% CI, 1.08-3.91; P=0.028); left atrial appendage diameter (OR, 1.06 per mm increase; 95% CI, 1.01-1.12; P=0.019); left ventricular ejection fraction (OR, 0.96 per 1% increase; 95% CI, 0.94-0.99; P=0.009). DRT and SSE both occurred in 17 of 65 patients (26.2%). Of the 19 SSE events in these patients with DRT, 9 of 19 (47.4%) and 12 of 19 (63.2%) occurred within 1 and 6 months of DRT detection. Conversely, after left atrial appendage closure, most SSEs (123/142, 86.62%) occurred in patients without DRT.Conclusions: After left atrial appendage closure with Watchman, DRT (≈3.7%) is not frequent but, when present, is associated with a higher rate of stroke and systemic embolism. [ABSTRACT FROM AUTHOR]

In contrast to ventricular tachycardia (VT) that occurs in the setting of a structurally normal heart, VT that occurs in patients with structural heart disease carries an elevated risk for sudden cardiac death (SCD), and implantable cardioverter-defibrillators (ICDs) are the mainstay of therapy. In these individuals, catheter ablation may be used as adjunctive therapy to treat or prevent repetitive ICD therapies when antiarrhythmic drugs are ineffective or not desired. However, certain patients with frequent premature ventricular contractions (PVCs) or VT and tachycardiomyopathy should be considered for ablation before ICD implantation because left ventricular function may improve, consequently decreasing the risk of SCD and obviating the need for an ICD. The goal of this paper is to review the pathophysiology, mechanism, and management of VT in the setting of structural heart disease and discuss the evolving role of catheter ablation in decreasing ventricular arrhythmia recurrence. [ABSTRACT FROM AUTHOR]

Catheter ablation of ventricular tachycardia (VT) is being increasingly performed; yet, there is often confusion regarding indications, outcomes, and how to identify those patient populations most likely to benefit. The management strategy differs between those with structural heart disease and those without. For the former, an implantable cardioverter-defibrillator (ICD) is typically required due to an elevated risk for sudden cardiac death, and catheter ablation can be used as adjunctive therapy to treat or prevent repetitive ICD therapies. In contrast, VT or premature ventricular contractions in the setting of a structurally normal heart carries a low risk for sudden cardiac death; accordingly, there is typically no indication for an ICD. In these patients, catheter ablation is considered for symptom management or to treat tachycardiomyopathy and is potentially curative. Here, the authors discuss the pathophysiology, mechanism, and management of VT that occurs in the setting of a structurally normal heart and the role of catheter ablation. [ABSTRACT FROM AUTHOR]

Background: Balloon catheters have been designed to facilitate pulmonary vein (PV) isolation in patients with paroxysmal atrial fibrillation (AF). The visually guided laser balloon (VGLB) employs laser energy to ablate tissue under direct visual guidance.Objectives: This study compared the efficacy and safety of VGLB ablation with standard irrigated radiofrequency ablation (RFA) during catheter ablation of AF.Methods: Patients with drug-refractory paroxysmal AF were enrolled in a multicenter, randomized controlled study of PV isolation using either the VGLB or RFA (control). The primary efficacy endpoint was freedom from protocol-defined treatment failure at 12 months, including symptomatic AF occurring after the 90-day blanking period. The primary efficacy and safety endpoints were powered for noninferiority.Results: A total of 353 patients (178 VGLB, 175 control) were randomized at 19 clinical sites. The mean procedure, ablation, and fluoroscopy times were longer with VGLB compared with controls. The primary efficacy endpoint was met in 61.1% in the VGLB group versus 61.7% in controls (absolute difference -0.6%; lower limit of 95% confidence interval [CI]: -9.3%; p = 0.003 for noninferiority). The primary adverse event rate was 11.8% in the VGLB group versus 14.5% in controls (absolute difference -2.8%; upper limit of 95% CI: 3.5; p = 0.002 for noninferiority), and was mainly driven by cardioversions. Diaphragmatic paralysis was higher (3.5% vs. 0.6%; p = 0.05), but PV stenosis was lower (0.0% vs. 2.9%; p = 0.03) with VGLB.Conclusions: Despite minimal prior experience, the safety and efficacy of VGLB ablation proved noninferior to RFA for the treatment of paroxysmal AF. (Pivotal Clinical Study of the CardioFocus Endoscopic Ablation System-Adaptive Contact [EAS-AC] [HeartLight] in Patients With Paroxysmal Atrial Fibrillation [PAF] [HeartLight]; NCT01456000). [ABSTRACT FROM AUTHOR]

Background: Contact force (CF) is a major determinant of lesion size and transmurality and has the potential to improve efficacy of atrial fibrillation ablation. This study sought to evaluate the safety and effectiveness of a novel irrigated radiofrequency ablation catheter that measures real-time CF in the treatment of patients with paroxysmal atrial fibrillation.Methods and Results: A total of 300 patients with symptomatic, drug-refractory, paroxysmal atrial fibrillation were enrolled in a prospective, multicenter, randomized, controlled trial and randomized to radiofrequency ablation with either a novel CF-sensing catheter or a non-CF catheter (control). The primary effectiveness end point consisted of acute electrical isolation of all pulmonary veins and freedom from recurrent symptomatic atrial arrhythmia off all antiarrhythmic drugs at 12 months. The primary safety end point included device-related serious adverse events. End points were powered to show noninferiority. All pulmonary veins were isolated in both groups. Effectiveness was achieved in 67.8% and 69.4% of subjects in the CF and control arms, respectively (absolute difference, -1.6%; lower limit of 1-sided 95% confidence interval, -10.7%; P=0.0073 for noninferiority). When the CF arm was stratified into optimal CF (≥90% ablations with ≥10 g) and nonoptimal CF groups, effectiveness was achieved in 75.9% versus 58.1%, respectively (P=0.018). The primary safety end point occurred in 1.97% and 1.40% of CF patients and control subjects, respectively (absolute difference, 0.57%; upper limit of 1-sided 95% confidence interval, 3.61%; P=0.0004 for noninferiority).Conclusions: The CF ablation catheter met the primary safety and effectiveness end points. Additionally, optimal CF was associated with improved effectiveness.Clinical Trial Registration: http://www.clinicaltrials.gov. Unique identifier: NCT01278953. [ABSTRACT FROM AUTHOR]

Background--Contact force (CF) is a major determinant of lesion size and transmurality and has the potential to improve efficacy of atrial fibrillation ablation. This study sought to evaluate the safety and effectiveness of a novel irrigated radiofrequency ablation catheter that measures real-time CF in the treatment of patients with paroxysmal atrial fibrillation. Methods and Results--A total of 300 patients with symptomatic, drug-refractory, paroxysmal atrial fibrillation were enrolled in a prospective, multicenter, randomized, controlled trial and randomized to radiofrequency ablation with either a novel CF-sensing catheter or a non-CF catheter (control). The primary effectiveness end point consisted of acute electrical isolation of all pulmonary veins and freedom from recurrent symptomatic atrial arrhythmia off all antiarrhythmic drugs at 12 months. The primary safety end point included device-related serious adverse events. End points were powered to show noninferiority. All pulmonary veins were isolated in both groups. Effectiveness was achieved in 67.8% and 69.4% of subjects in the CF and control arms, respectively (absolute difference, -1.6%; lower limit of 1-sided 95% confidence interval, -10.7%; P=0.0073 for noninferiority). When the CF arm was stratified into optimal CF (≥90% ablations with ≥10 g) and nonoptimal CF groups, effectiveness was achieved in 75.9% versus 58.1%, respectively (P=0.018). The primary safety end point occurred in 1.97% and 1.40% of CF patients and control subjects, respectively (absolute difference, 0.57%; upper limit of 1-sided 95% confidence interval, 3.61%; P=0.0004 for noninferiority). Conclusions--The CF ablation catheter met the primary safety and effectiveness end points. Additionally, optimal CF was associated with improved effectiveness. [ABSTRACT FROM AUTHOR]

Visually Guided PV Isolation Introduction Visually guided laser balloon (VGLB) ablation is unique in that the operator delivers ablative energy under direct visual guidance. In this multicenter study, we sought to determine the feasibility, efficacy, and safety of performing pulmonary vein isolation (PVI) using this VGLB. Methods Patients with symptomatic, drug-refractory paroxysmal atrial fibrillation (AF) underwent PVI using the VGLB with the majority of operators conducting their first-ever clinical VGLB cases. The primary effectiveness endpoint was defined as freedom from treatment failure that included: Occurrence of symptomatic AF episodes ≥1 minutes beyond the 90-day blanking, the inability to isolate 1 superior and 2 total PVs, occurrence of left atrial flutter or atrial tachycardia, or left atrial ablation/surgery during follow-up. Results A total of 86 patients (mean age 56 ± 10 years, 67% male) were treated with the VGLB at 10 US centers. Mean fluoroscopy, ablation, and procedure times were 39.8 ± 24.3 minutes, 205.2 ± 61.7 minutes, and 253.5 ± 71.3 minutes, respectively. Acute PVI was achieved in 314/323 (97.2%) of targeted PVs. Of 84 patients completing follow-up, the primary effectiveness endpoint was achieved in 50 (60%) patients. Freedom from symptomatic or asymptomatic AF was 61%. The primary adverse event rate was 16.3% (8.1% pericarditis, phrenic nerve injury 5.8%, and cardiac tamponade 3.5%). There were no cerebrovascular events, atrioesophageal fistulas, or significant PV stenosis. Conclusions This multicenter study of operators in the early stage of the learning curve demonstrates that PVI can be achieved with the VGLB with a reasonable safety profile and an efficacy similar to radiofrequency ablation. [ABSTRACT FROM AUTHOR]

Objectives: Our goal was to investigate the effects of percutaneous left ventricular assist device (pLVAD) support during catheter ablation of unstable ventricular tachycardia (VT). Background: Mechanical cardiac support during ablation of unstable VT is being increasingly used, but there is little available information on the potential hemodynamic benefits. Methods: Twenty-three consecutive procedures in 22 patients (ischemic, n = 11) with structural heart disease and hemodynamically unstable VT were performed with either pLVAD support (n = 10) or no pLVAD support (intra-aortic balloon pump counterpulsation, n = 6; no support, n = 7). Procedural monitoring included vital signs, left atrial pressure, arterial blood pressure, cerebral perfusion/oximetry, VT characteristics, and ablation outcomes. Results: The pLVAD group was maintained in VT significantly longer than the non-pLVAD group (66.7 min vs. 27.5 min; p = 0.03) and required fewer early terminations of sustained VT for hemodynamic instability (1.0 vs. 4.0; p = 0.001). More patients in the pLVAD group had at least 1 VT termination during ablation than non-pLVAD patients (9 of 10 [90%] vs. 5 of 13 [38%]; p = 0.03). There were no differences between groups in duration of cerebral deoxygenation, hypotension or perioperative changes in left atrial pressure, brain natriuretic peptide levels, lactic acid, or renal function. Conclusions: In patients with scar-related VT undergoing catheter ablation, pLVAD support was able to safely maintain end-organ perfusion despite extended periods of hemodynamically unstable VT. Randomized studies are necessary to determine whether this enhanced ability to perform entrainment and activation mapping will translate into a higher rate of clinical success. [Copyright &y& Elsevier]

Patients with acute right ventricular (RV) infarctions are prone to ventricular arrhythmias, but little is known regarding the temporal patterns of these arrhythmias, their impact on outcomes, or their relation to the severity of RV impairment. The aim of this study was to examine the impact of malignant ventricular arrhythmias (MVAs) complicating acute RV infarction. A further aim was to determine whether the degree of RV impairment was a predisposing factor to MVAs. The charts of 48 patients with acute RV infarctions were reviewed for documented MVAs. Temporal presentation, relating to reperfusion, and in-hospital outcomes were tabulated. Echocardiograms were reviewed to quantify RV impairment. MVAs occurred in 38% of patients, with multiple episodes (electrical storm) in 8.3%. MVAs developed before reperfusion (72% of patients), abruptly with reperfusion (11%), or after reperfusion (22%). Patients with MVAs had larger infarcts (peak creatine phosphokinase 3,027 vs 1,848 U/L, p = 0.03) and trended toward worse RV function (fractional shortening 27% vs 34%, p = 0.08). In-hospital mortality (patients with MVAs 17% vs 6.7%, p = 0.35), intensive care days (patients with MVAs 7.1 ± 10 vs 3.9 ± 2.5, p = 0.39), and hospital days (patients with MVAs 10.3 ± 10 vs 8.0 ± 5.1, p = 0.57) were similar between groups. Patients with electrical storm had longer intensive care stays (18.0 ± 18.5 vs 4.0 ± 2.5 days, p = 0.02) and hospital stays (20.5 ± 17 vs 7.9 ± 5.0 days, p = 0.05). In conclusion, MVAs are common in acute RV infarctions. They frequently occur before reperfusion and are associated with larger infarcts. With reperfusion, MVAs had little impact on intensive care and hospital stays or in-hospital mortality, except in patients with electrical storm. [Copyright &y& Elsevier]

Introduction: Multiple randomized controlled trials have demonstrated sodium‐glucose cotransporter‐2 inhibitors (SGLT2i) decrease the composite endpoint of cardiovascular death or heart failure hospitalizations in all heart failure patients. It is uncertain whether SGLT2i impacts the risk of sudden cardiac death in patients with heart failure. Methods: A comprehensive search was performed to identify relevant data published before August 28, 2022. Trials were included if: (1) all patients had clinical heart failure (2) SGLT2i and placebo were compared (3) all patients received conventional medical therapy and (4) reported outcomes of interest (sudden cardiac death [SCD], ventricular arrhythmias, atrial arrhythmias). Results: SCD was reported in seven of the eleven trials meeting selection criteria: 10 796 patients received SGLT2i and 10 796 received placebo. SGLT2i therapy was associated with a significant reduction in the risk of SCD (risk ratios [RR]: 0.68; 95% confidence intervals [CI]: 0.48−0.95; p =.03; I2 = 0%). Absent dedicated rhythm monitoring, there were no significant differences in the incidence of sustained ventricular arrhythmias not associated with SCD (RR: 1.03; 95% CI: 0.83−1.29; p =.77; I2 = 0%) or atrial arrhythmias (RR: 0.91; 95% CI: 0.77–1.09; p =.31; I2 = 29%) between patients receiving an SGLT2i versus placebo. Conclusion: SGLT2i therapy is associated with a reduced risk of SCD in patients with heart failure receiving contemporary medical therapy. Prospective trials are needed to determine the long‐term impact of SGLT2i therapy on atrial and ventricular arrhythmias. [ABSTRACT FROM AUTHOR]

Introduction: Visually‐guided laser balloon ablation (VGLA) currently requires careful manual rotation of the laser to create overlapping lesions. A novel semi‐automated VGLA may reduce ablation times and lesion gaps. We aimed to compare semi‐automated (SA) VGLA to that of manual (MN) VGLA. Methods: Acute: Nine swine underwent right superior pulmonary vein isolation (PVI) using either SA (n = 3, 13–18 W), MN (n = 3, 8.5–12 W), or radiofrequency (RF, n = 3, 25–40 W) and were killed acutely. Chronic: 16 swine, underwent PVI using either SA (n = 8, 15 W) or MN (n = 8, 10 W), and were survived for 1 month before being killed. All hearts were then submitted for pathological evaluation. Results: Acute: PVI was successful in all 9/9 swine with lesion counts significantly lower in the SA arm (5.3 ± 5.9, 33.7 ± 10.0, and 28.0 ± 4.4 in SA, MN, and RF arms; p =.007 for SA and MN). At necropsy, circumferentiality and transmurality were 98% and 94% in SA, 98% and 80% in MN, and 100% and 100% in RF arms. A single steam pop was noted on sectioning in the SA arm swine and occurred in the high dose (18 W) strategy. Chronic: PVI was acutely successful in 16/16 swine with no difference in PVI durability rates (62.5% vs. 75.0%), lesion transmurality (95.8 ± 17.4% vs.91.9 ± 25.9%), and circumferentiality (95.8 ± 6.6% vs. 94.8 ± 6.3%) between SA and MN arms. Catheter use time and lesion counts were lower in the SA arm compared to the MN arm (11.5 ± 12.7 vs. 21.8 ± 3.8 min, p =.046 and 4.8 ± 3.83 vs. 35.4 ± 4.4, p <.001). Conclusion: Motor‐assisted semi‐automated laser balloon ablation can improve upon procedural efficiency by reducing ablation time. [ABSTRACT FROM AUTHOR]

The conventional view holds that functional mitral regurgitation (MR) is caused by restriction of leaflet motion resulting from displacement of the papillary muscle-bearing segments of the left ventricle. In the past decade, evidence has accrued suggesting functional MR can also be caused by left atrial enlargement. This underrecognized cause of secondary MR—atrial functional MR (AF-MR)—is mechanistically linked to annular enlargement, perturbations of annular contraction, and atriogenic leaflet tethering. AF-MR has been described in patients with atrial fibrillation and heart failure with preserved ejection fraction. Preliminary data suggest rhythm control may decrease MR severity in patients with atrial fibrillation. Additionally, several studies have reported reductions in MR and symptomatic improvement with restrictive annuloplasty and transcatheter edge-to-edge repair. This review discusses the pathophysiology, echocardiographic diagnosis, and treatment of AF-MR. AF-tricuspid regurgitation is also discussed. [Display omitted] • Atrial functional MR is an underrecognized cause of secondary MR. • Atrial fibrillation and HFpEF are associated with atrial functional MR. • Preliminary evidence suggests that rhythm control may reduce the severity of AF-MR, but further studies are needed. [ABSTRACT FROM AUTHOR]

Despite significant advances in battery longevity, lead performance, and programming features since the first implanted permanent pacemaker was developed, the basic design of cardiac pacemakers has remained relatively unchanged over the past 50 years. Because of inherent limitations in their design, conventional (transvenous) pacemakers are prone to multiple potential short- and long-term complications. Accordingly, there has been intense interest in a system able to provide the symptomatic and potentially lifesaving therapies of cardiac pacemakers while mitigating many of the risks associated with their weakest link—the transvenous lead. Leadless cardiac pacing represents the future of cardiac pacing systems, similar to the transition that occurred from the use of epicardial pacing systems to the familiar transvenous systems of today. This review summarizes the current evidence and potential benefits of leadless pacing systems, which are either commercially available (in Europe) or under clinical investigation. [ABSTRACT FROM AUTHOR]

Background: Increasing interest in physiological pacing has been countered with challenges such as accurate lead deployment and increasing pacing thresholds with His‐bundle pacing (HBP). More recently, left bundle branch area pacing (LBBAP) has emerged as an alternative approach to physiologic pacing. Objective: To compare procedural outcomes and pacing parameters at follow‐up during initial adoption of HBP and LBBAP at a single center. Methods: Retrospective review, from September 2016 to January 2020, identified the first 50 patients each who underwent successful HBP or LBBAP. Pacing parameters were then assessed at first follow‐up after implantation and after approximately 1 year, evaluating for acceptable pacing parameters defined as sensing R‐wave amplitude >5 mV, threshold <2.5 V @ 0.5 ms, and impedance between 400 and 1200 Ω. Results: The HBP group was younger with lower ejection fraction compared to LBBAP (73.2 ± 15.3 vs. 78.2 ± 9.2 years, p =.047; 51.0 ± 15.9% vs. 57.0 ± 13.1%, p =.044). Post‐procedural QRS widths were similarly narrow (119.8 ± 21.2 vs. 116.7 ± 15.2 ms; p =.443) in both groups. Significantly fewer patients with HBP met the outcome for acceptable pacing parameters at initial follow‐up (56.0% vs. 96.4%, p =.001) and most recent follow‐up (60.7% vs. 94.9%, p ≤.001; at 399 ± 259 vs. 228 ± 124 days, p ≤.001). More HBP patients required lead revision due to early battery depletion or concern for pacing failure (0% vs. 13.3%, at a mean of 664 days). Conclusion: During initial adoption, HBP is associated with a significantly higher frequency of unacceptable pacing parameters, energy consumption, and lead revisions compared with LBBAP. [ABSTRACT FROM AUTHOR]

Adjunctive Renal Sympathetic Denervation to Modify Hypertension Background Hypertension is the most important risk factor directly attributable to the high prevalence of atrial fibrillation (AF), and is one of the few modifiable risk factors for AF. Activation and overactivity of the sympathetic nervous system (SNS) have been implicated in the pathogenesis of both essential hypertension and AF. Catheter-based renal sympathetic denervation (RSDN) appears to be an effective adjunctive treatment for refractory hypertension, and may be beneficial in other conditions characterized by SNS overactivity, such as left ventricular hypertrophy and atrial arrhythmias. Objective The H-FIB study is a multicenter prospective, double-blind, randomized (1:1) controlled trial. The primary efficacy endpoint is antiarrhythmic drug-free freedom from AF recurrence through 12 months. Methods Patients with a history of significant hypertension who are receiving treatment with at least one antihypertensive agent who are planned for a first time ablation for symptomatic paroxysmal or persistent AF will be randomized to either AF ablation alone (control group) or AF ablation + RSDN (study group). Conclusions H-FIB is a multicenter, randomized trial that will test the hypothesis that adjunctive renal sympathetic denervation, at the time of AF ablation, will increase the freedom from recurrent AF. [ABSTRACT FROM AUTHOR]

Background: Left atrial appendage (LAA) occlusion provides an alternative to oral anticoagulation for thromboembolic risk reduction in patients with nonvalvular atrial fibrillation. Since regulatory approval in 2015, the WATCHMAN device has been the only LAA closure device available for clinical use in the United States. The PINNACLE FLX study (Protection Against Embolism for Nonvalvular AF Patients: Investigational Device Evaluation of the Watchman FLX LAA Closure Technology) evaluated the safety and effectiveness of the next-generation WATCHMAN FLX LAA closure device in patients with nonvalvular atrial fibrillation in whom oral anticoagulation is indicated, but who have an appropriate rationale to seek a nonpharmaceutical alternative.Methods: This was a prospective, nonrandomized, multicenter US Food and Drug Administration study. The primary safety end point was the occurrence of one of the following events within 7 days after the procedure or by hospital discharge, whichever was later: death, ischemic stroke, systemic embolism, or device- or procedure-related events requiring cardiac surgery. The primary effectiveness end point was the incidence of effective LAA closure (peri-device flow ≤5 mm), as assessed by the echocardiography core laboratory at 12-month follow-up.Results: A total of 400 patients were enrolled. The mean age was 73.8±8.6 years and the mean CHA2DS2-VASc score was 4.2±1.5. The incidence of the primary safety end point was 0.5% with a 1-sided 95% upper CI of 1.6%, meeting the performance goal of 4.2% (P<0.0001). The incidence of the primary effectiveness end point was 100%, with a 1-sided 95% lower CI of 99.1%, again meeting the performance goal of 97.0% (P<0.0001). Device-related thrombus was reported in 7 patients, no patients experienced pericardial effusion requiring open cardiac surgery, and there were no device embolizations.Conclusions: LAA closure with this next-generation LAA closure device was associated with a low incidence of adverse events and a high incidence of anatomic closure. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT02702271. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

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, CHA2DS2‐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. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

Background: Unlike for paroxysmal atrial fibrillation (AF), pulmonary vein isolation (PVI) alone is considered insufficient for many patients with persistent AF. Adjunctive ablation of the left atrial posterior wall (LAPW) may improve outcomes, but is limited by both the difficulty of achieving lesion durability and concerns of damage to the esophagus-situated behind the LAPW.Objectives: This study sought to assess the safety and lesion durability of pulsed field ablation (PFA) for both PVI and LAPW ablation in persistent AF.Methods: PersAFOne is a single-arm study evaluating biphasic, bipolar PFA using a multispline catheter for PVI and LAPW ablation under intracardiac echocardiographic guidance. A focal PFA catheter was used for cavotricuspid isthmus ablation. No esophageal protection strategy was used. Invasive remapping was mandated at 2 to 3 months to assess lesion durability.Results: In 25 patients, acute PVI (96 of 96 pulmonary veins [PVs]; mean ablation time: 22 min; interquartile range [IQR]: 15 to 29 min) and LAPW ablation (24 of 24 patients; median ablation time: 10 min; IQR: 6 to 13 min) were 100% acutely successful with the multispline PFA catheter alone. Using the focal PFA catheter, acute cavotricuspid isthmus block was achieved in 13 of 13 patients (median: 9 min; IQR: 6 to 12 min). The median total procedure time was 125 min (IQR: 108 to 166 min) (including a median of 28 min [IQR: 25 to 33 min] for voltage mapping), with a median of 16 min (IQR: 12 to 23 min) fluoroscopy. Post-procedure esophagogastroduodenoscopy and repeat cardiac computed tomography revealed no mucosal lesions or PV narrowing, respectively. Invasive remapping demonstrated durable isolation (defined by entrance block) in 82 of 85 PVs (96%) and 21 of 21 LAPWs (100%) treated with the pentaspline catheter. In 3 patients, there was localized scar regression of the LAPW ablation, albeit without conduction breakthrough.Conclusions: The unique safety profile of PFA potentiated efficient, safe, and durable PVI and LAPW ablation. This extends the potential role of PFA beyond paroxysmal to persistent forms of AF. (Pulsed Fields for Persistent Atrial Fibrillation [PersAFOne]; NCT04170621). [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

Background: Catheter ablation of atrial fibrillation using thermal energies such as radiofrequency or cryothermy is associated with indiscriminate tissue destruction. During pulsed field ablation (PFA), subsecond electric fields create microscopic pores in cell membranes-a process called electroporation. Among cell types, cardiomyocytes have among the lowest thresholds to these fields, potentially permitting preferential myocardial ablation.Objectives: The purpose of these 2 trials was to determine whether PFA allows durable pulmonary vein (PV) isolation without damage to collateral structures.Methods: Two trials were conducted to assess the safety and effectiveness of catheter-based PFA in paroxysmal atrial fibrillation. Ablation was performed using proprietary bipolar PFA waveforms: either monophasic with general anesthesia and paralytics to minimize muscle contraction, or biphasic with sedation because there was minimal muscular stimulation. No esophageal protection strategy was used. Invasive electrophysiological mapping was repeated after 3 months to assess the durability of PV isolation.Results: In 81 patients, all PVs were acutely isolated by monophasic (n = 15) or biphasic (n = 66) PFA with ≤3 min elapsed delivery/patient, skin-to-skin procedure time of 92.2 ± 27.4 min, and fluoroscopy time of 13.1 ± 7.6 min. With successive waveform refinement, durability at 3 months improved from 18% to 100% of patients with all PVs isolated. Beyond 1 procedure-related pericardial tamponade, there were no additional primary adverse events over the 120-day median follow-up, including: stroke, phrenic nerve injury, PV stenosis, and esophageal injury. The 12-month Kaplan-Meier estimate of freedom from arrhythmia was 87.4 ± 5.6%.Conclusions: In first-in-human trials, PFA preferentially affected myocardial tissue, allowing facile ultra-rapid PV isolation with excellent durability and chronic safety. (IMPULSE: A Safety and Feasibility Study of the IOWA Approach Endocardial Ablation System to Treat Atrial Fibrillation; NCT03700385; and PEFCAT: A Safety and Feasibility Study of the FARAPULSE Endocardial Ablation System to Treat Paroxysmal Atrial Fibrillation; NCT03714178). [ABSTRACT FROM AUTHOR]

Introduction: The subcutaneous implantable cardioverter‐defibrillator (S‐ICD) is most commonly implanted under general anesthesia (GA), due to the intraoperative discomfort associated with tunneling and dissection. Postoperative pain can be substantial and is often managed with opioids. There is a growing interest in transitioning away from the routine use of GA during S‐ICD implantation, while also controlling perioperative discomfort without the use of narcotics. As such, we assessed the feasibility of a multimodal analgesia regimen that included regional anesthesia techniques in patients undergoing S‐ICD implantation. Methods and Results: Twenty patients received truncal plane block (TBL) immediately before S‐ICD implantation. The first 10 patients were implanted under general anesthesia (GA + TBL), and the next 10 patients were implanted under deep sedation (DS + TBL). Additionally, the DS + TBL patients were also prescribed a structured regimen of nonopioid analgesics in the perioperative period. Opioid consumption was calculated as milligram morphine equivalents (MME). In‐hospital opioid consumption was significantly lower in the patients implanted with DS + TBL (MME = 0) as compared with patients receiving GA + TBL (MME = 60; P = 0.004). Conclusions: Subcutaneous ICD implantation with anesthesia‐delivered DS and a multimodal anesthetic regimen that includes TBL is feasible and associated with significantly less perioperative opioid consumption. The subcutaneous implantable cardioverter‐defibrillator (S‐ICD) is most commonly implanted under general anesthesia (GA) due to the intraoperative discomfort associated with tunneling and dissection. Postoperative pain can be substantial, and is often managed with opioids. [ABSTRACT FROM AUTHOR]

This article has been corrected. The original version (PDF) is appended to this article as a Supplement.Background: Atrial fibrillation (AF) and heart failure (HF) frequently coexist and are associated with increased morbidity and mortality risk.Purpose: To compare benefits and harms between catheter ablation and drug therapy in adult patients with AF and HF.Data Sources: ClinicalTrials.gov, PubMed, Web of Science (Clarivate Analytics), EBSCO Information Services, Cochrane Central Register of Controlled Trials, Google Scholar, and various scientific conference sessions from 1 January 2005 to 1 October 2018.Study Selection: Randomized controlled trials (RCTs) published in English that had at least 6 months of follow-up and compared clinical outcomes of catheter ablation versus drug therapy in adults with AF and HF.Data Extraction: 2 investigators independently extracted data and assessed study quality.Data Synthesis: 6 RCTs involving 775 patients met inclusion criteria. Compared with drug therapy, AF ablation reduced all-cause mortality (9.0% vs. 17.6%; risk ratio [RR], 0.52 [95% CI, 0.33 to 0.81]) and HF hospitalizations (16.4% vs. 27.6%; RR, 0.60 [CI, 0.39 to 0.93]). Ablation improved left ventricular ejection fraction (LVEF) (mean difference, 6.95% [CI, 3.0% to 10.9%]), 6-minute walk test distance (mean difference, 20.93 m [CI, 5.91 to 35.95 m]), peak oxygen consumption (Vo2max) (mean difference, 3.17 mL/kg per minute [CI, 1.26 to 5.07 mL/kg per minute]), and quality of life (mean difference in Minnesota Living with Heart Failure Questionnaire score, -9.02 points [CI, -19.75 to 1.71 points]). Serious adverse events were more common in the ablation groups, although differences between the ablation and drug therapy groups were not statistically significant (7.2% vs. 3.8%; RR, 1.68 [CI, 0.58 to 4.85]).Limitation: Results driven primarily by 1 clinical trial, possible patient selection bias in the ablation group, lack of patient-level data, open-label trial designs, and heterogeneous follow-up length among trials.Conclusion: Catheter ablation was superior to conventional drug therapy in improving all-cause mortality, HF hospitalizations, LVEF, 6-minute walk test distance, Vo2max, and quality of life, with no statistically significant increase in serious adverse events.Primary Funding Source: None. [ABSTRACT FROM AUTHOR]

Compared with warfarin, left atrial appendage closure (LAAC) reduced mortality in an analysis of the PROTECT AF and PREVAIL trials. However, these data were limited by patient drop-out.We sought to estimate the mortality benefit with LAAC using updated vital status information.In PROTECT AF and PREVAIL, 227 of 1114 randomized subjects failed to complete 5-year follow-up. Centers were manually queried for updated vital status on 76 subjects (33%). During median follow-up 5.0 years (interquartile range 3.8, 5.1), 112 of 732 LAAC subjects (15.3%) and 79 of 382 controls (20.7%) died. The hazard ratio for all-cause mortality with LAAC compared with warfarin was 0.70 (95% CI 0.53-0.94, p=0.017).Subgroup analyses suggested that subjects <75 years and those with higher CHA2DS2-VASc score, history of transient ischemic attack or stroke, and permanent AF derived particular benefit, although interaction terms were not significant.The number needed to treat(NNT) with LAAC to prevent one death over 5 years was 16 (95% CI 10-82). Despite competing mortality risks in this elderly cohort, updated vital status data from PROTECT AF and PREVAIL revealed that LAAC was associated with 30% improved survival compared with warfarin, with an NNT of 16. [ABSTRACT FROM AUTHOR]

Introduction There is a paucity of data in favor of mechanical support during catheter ablation of ventricular tachycardia (VT). This study investigated the outcomes of VT ablation associated with mechanical support using percutaneous ventricular assist device (PVAD) versus intra-aortic balloon pump (IABP). Methods and results We retrospectively examined the outcomes of patients who underwent VT ablation associated with PVAD versus IABP from 2010 to 2013, captured by the Medicare Inpatient Standard Analytic File database. Data from 345 patients (PVAD = 230, IABP = 115) were examined. On admission, the incidence of heart failure was higher in PVAD (84.3% vs. 73.0%; P = 0.01) with similar rates of renal failure in PVAD versus IABP (33.0% vs. 37.4%; P = 0.42). However, PVAD was associated with reduced in-hospital cardiogenic shock (9.1% vs. 23.5%; P < 0.001), renal failure (11.7% vs. 21.7%; P = 0.01), and length of stay (8.4 ± 7.9 vs. 10.6 ± 7.5; P < 0.001), but with greater hospital discharges to home/self-care (66.0% vs. 51.6%; P = 0.02). Index mortality (6.5% vs. 19.1%; P = 0.001) and mortality in patients with cardiogenic shock (18.2% vs. 41.2%; P = 0.03) were significantly lower with PVAD versus IABP. Furthermore, PVAD was associated with lower all-cause (27.0% vs. 38.7%; P = 0.04) and heart failure-related (21.4% vs. 33.3%; P = 0.03) 30-day hospital readmissions, but with similar redo-VT ablation rates at 1 year (10.2% vs. 14.0%; P = 0.34). Conclusion Among the cases captured by the Medicare database, catheter ablation of VT associated with mechanical support using PVAD was associated with reduced in-hospital cardiogenic shock, renal failure, length of stay, hospital readmissions and mortality, but no difference in redo-VT ablation at 1 year. [ABSTRACT FROM AUTHOR]

The clinical use of ivabradine has and continues to evolve along channels that are predicated on its mechanism of action. It selectively inhibits the funny current (If) in sinoatrial nodal tissue, resulting in a decrease in the rate of diastolic depolarization and, consequently, the heart rate, a mechanism that is distinct from those of other negative chronotropic agents. Thus, it has been evaluated and is used in select patients with systolic heart failure and chronic stable angina without clinically significant adverse effects. Although not approved for other indications, ivabradine has also shown promise in the management of inappropriate sinus tachycardia. Here, the authors review the mechanism of action of ivabradine and salient studies that have led to its current clinical indications and use. [ABSTRACT FROM AUTHOR]

Background: Saline irrigation improved the safety of radiofrequency (RF) ablation, but the thermal feedback for energy titration is absent.Objectives: To allow temperature-controlled irrigated ablation, a novel irrigated RF catheter was designed with a diamond-embedded tip (for rapid cooling) and 6 surface thermocouples to reflect tissue temperature. High-resolution electrograms (EGMs) from the split-tip electrode allowed rapid lesion assessment. The authors evaluated the preclinical and clinical performance of this catheter for pulmonary vein (PV) isolation.Methods: Using the DiamondTemp (DT) catheter, pigs (n = 6) underwent discrete atrial ablation in a temperature control mode (60°C/50 W) until there was ∼80% EGM amplitude reduction. In a single-center clinical feasibility study, 35 patients underwent PV isolation with the DT catheter (study group); patients were planned for PV remapping after 3 months, regardless of symptomatology. A control group included 35 patients who underwent PV isolation with a standard force-sensing catheter.Results: Porcine lesion histology revealed transmurality in 51 of 55 lesions (92.7%). In patients, all PVs were successfully isolated; no char or thrombus formation was observed. Compared with the control group, the study cohort had shorter mean RF application duration (26.3 ± 5.2 min vs. 89.2 ± 27.2 min; p < 0.001), shorter mean fluoroscopic time (11.2 ± 8.5 min vs. 19.5 ± 6.8 min; p < 0.001), and lower acute dormant PV reconduction (0 of 35 vs. 5 of 35; p = 0.024). At 3 months, 23 patients underwent remapping: 39 of 46 PV pairs (84.8%) remained durably isolated in 17 of these patients (73.9%).Conclusions: This first-in-human series demonstrated that temperature-controlled irrigated ablation produced rapid, efficient, and durable PV isolation. (ACT DiamondTemp Temperature-Controlled and Contact Sensing RF Ablation Clinical Trial for Atrial Fibrillation [TRAC-AF]; NCT02821351). [ABSTRACT FROM AUTHOR]

Gender and Persistent AF Introduction Atrial fibrillation (AF) ablation is less frequently performed in women when compared to men. There are conflicting data on the safety and efficacy of AF ablation in women. The objective of this study was to compare the clinical characteristics and outcomes in a contemporary cohort of men and women undergoing persistent AF ablation procedures. Methods and Results A total of 182 men and 53 women undergoing a first-ever persistent AF catheter ablation procedure in The Modified Ablation Guided by Ibutilide Use in Chronic Atrial Fibrillation (MAGIC-AF) trial were evaluated. Clinical and procedural characteristics were compared between each gender. The primary efficacy endpoint was the 1-year single procedure freedom from atrial arrhythmia off anti-arrhythmic drugs. Women undergoing catheter ablation procedures were older than men (P < 0.001). The duration of AF and associated co-morbidities were similar between both genders. Single procedure drug-free atrial arrhythmia recurrence occurred in 53% of the cohort with no difference based on gender (men = 54%, women = 53%; P = 1.0). Procedural (P = 0.04), fluoroscopic (P = 0.02), and ablation times (P = 0.003) were shorter in women compared to men. Periprocedural complications and postablation improvement in quality of life were similar between men and women. Conclusion Women undergoing a first-ever persistent AF ablation procedure were older but had similar clinical outcomes and complications when compared with men. [ABSTRACT FROM AUTHOR]

Background: Cardiac pacemakers are limited by device-related complications, notably infection and problems related to pacemaker leads. We studied a miniaturized, fully self-contained leadless pacemaker that is nonsurgically implanted in the right ventricle with the use of a catheter.Methods: In this multicenter study, we implanted an active-fixation leadless cardiac pacemaker in patients who required permanent single-chamber ventricular pacing. The primary efficacy end point was both an acceptable pacing threshold (≤2.0 V at 0.4 msec) and an acceptable sensing amplitude (R wave ≥5.0 mV, or a value equal to or greater than the value at implantation) through 6 months. The primary safety end point was freedom from device-related serious adverse events through 6 months. In this ongoing study, the prespecified analysis of the primary end points was performed on data from the first 300 patients who completed 6 months of follow-up (primary cohort). The rates of the efficacy end point and safety end point were compared with performance goals (based on historical data) of 85% and 86%, respectively. Additional outcomes were assessed in all 526 patients who were enrolled as of June 2015 (the total cohort).Results: The leadless pacemaker was successfully implanted in 504 of the 526 patients in the total cohort (95.8%). The intention-to-treat primary efficacy end point was met in 270 of the 300 patients in the primary cohort (90.0%; 95% confidence interval [CI], 86.0 to 93.2, P=0.007), and the primary safety end point was met in 280 of the 300 patients (93.3%; 95% CI, 89.9 to 95.9; P<0.001). At 6 months, device-related serious adverse events were observed in 6.7% of the patients; events included device dislodgement with percutaneous retrieval (in 1.7%), cardiac perforation (in 1.3%), and pacing-threshold elevation requiring percutaneous retrieval and device replacement (in 1.3%).Conclusions: The leadless cardiac pacemaker met prespecified pacing and sensing requirements in the large majority of patients. Device-related serious adverse events occurred in approximately 1 in 15 patients. (Funded by St. Jude Medical; LEADLESS II ClinicalTrials.gov number, NCT02030418.). [ABSTRACT FROM AUTHOR]

Background A leadless cardiac pacemaker (LCP) system was recently introduced to overcome lead-related complications of conventional pacing systems. To date, long-term results of an LCP system are unknown. Objectives The aim of this study was to assess the complication incidence, electrical performance, and rate response characteristics within the first year of follow-up of patients implanted with an LCP. Methods We retrospectively assessed intermediate-term follow-up data for 31 of 33 patients from the LEADLESS trial cohort who had an indication for single-chamber pacing and received an LCP between December 2012 and April 2013. Results The mean age of the cohort was 76 ± 8 years, and 65% were male. Between 3 and 12 months of follow-up, there were no pacemaker-related adverse events reported. The pacing performance results at 6- and 12-month follow-up were, respectively, as follows: mean pacing threshold (at a 0.4-ms pulse width), 0.40 ± 0.26 V and 0.43 ± 0.30 V; R-wave amplitude 10.6 ± 2.6 mV and 10.3 ± 2.2 mV; and impedance 625 ± 205 Ω and 627 ± 209 Ω. At the 12-month follow-up in 61% of the patients (n = 19 of 31), the rate response sensor was activated, and an adequate rate response was observed in all patients. Conclusions The LCP demonstrates very stable performance and reassuring safety results during intermediate-term follow-up. These results support the use of the LCP as a promising alternative to conventional pacemaker systems. Continued evaluation is warranted to further characterize this system. (Evaluation of a New Cardiac Pacemaker; NCT01700244 ) [ABSTRACT FROM AUTHOR]

Bipolar Ablation for Outflow Tract VT Introduction Standard unipolar radiofrequency ablation (RFA) is typically successful in eliminating premature ventricular contractions (PVCs) originating from the ventricular outflow tract region. In a minority of cases, this approach may be ineffective. We report 4 cases where bipolar RFA was attempted after failed unipolar RFA. Methods From a total of 73 consecutive PVC ablations, 4 patients underwent bipolar RFA after failed unipolar ablation. Three-dimensional electroanatomic activation mapping of the right and left ventricular outflow (RVOT and LVOT), coronary sinus, and aortic root was performed. Results Mean age was 53 ± 22 years, 3 male. The mean 24-hour PVC burden in these patients was 33,107 ± 8,712. In 3 of 4 patients, the RVOT activation was earlier than the left side. The earliest activation on the left was in the right coronary cusp in 2 patients and left coronary cusp in 2. Unipolar RFA delivered sequentially at the site of earliest RVOT and then earliest aortic cusp sites failed to eradicate the PVCs in all 4 patients. Subsequently, bipolar RFA was applied between irrigated catheters placed at the earliest RVOT and aortic root sites. This approach eliminated PVCs in 3 of 4 (75%) cases. At a median follow-up of 4 months, those with successful bipolar RFA had no recurrence of clinical PVCs. Conclusions This report demonstrates the potential utility of bipolar RFA in patients with outflow tract PVCs that fail unipolar RFA. [ABSTRACT FROM AUTHOR]

Background: Conventional cardiac pacemakers are associated with several potential short- and long-term complications related to either the transvenous lead or subcutaneous pulse generator. We tested the safety and clinical performance of a novel, completely self-contained leadless cardiac pacemaker.Methods and Results: The primary safety end point was freedom from complications at 90 days. Secondary performance end points included implant success rate, implant time, and measures of device performance (pacing/sensing thresholds and rate-responsive performance). The mean age of the patient cohort (n=33) was 77±8 years, and 67% of the patients were male (n=22/33). The most common indication for cardiac pacing was permanent atrial fibrillation with atrioventricular block (n=22, 67%). The implant success rate was 97% (n=32). Five patients (15%) required the use of >1 leadless cardiac pacemaker during the procedure. One patient developed right ventricular perforation and cardiac tamponade during the implant procedure, and eventually died as the result of a stroke. The overall complication-free rate was 94% (31/33). After 3 months of follow-up, the measures of pacing performance (sensing, impedance, and pacing threshold) either improved or were stable within the accepted range.Conclusions: In a prospective nonrandomized study, a completely self-contained, single-chamber leadless cardiac pacemaker has shown to be safe and feasible. The absence of a transvenous lead and subcutaneous pulse generator could represent a paradigm shift in cardiac pacing.Clinical Trial Registration Url: http://clinicaltrials.gov. Unique identifier: NCT01700244. [ABSTRACT FROM AUTHOR]

Background--Conventional cardiac pacemakers are associated with several potential short- and long-term complications related to either the transvenous lead or subcutaneous pulse generator. We tested the safety and clinical performance of a novel, completely self-contained leadless cardiac pacemaker. Methods and Results--The primary safety end point was freedom from complications at 90 days. Secondary performance end points included implant success rate, implant time, and measures of device performance (pacing/sensing thresholds and rate-responsive performance). The mean age of the patient cohort (n=33) was 77±8 years, and 67% of the patients were male (n=22/33). The most common indication for cardiac pacing was permanent atrial fibrillation with atrioventricular block (n=22, 67%). The implant success rate was 97% (n=32). Five patients (15%) required the use of > 1 leadless cardiac pacemaker during the procedure. One patient developed right ventricular perforation and cardiac tamponade during the implant procedure, and eventually died as the result of a stroke. The overall complication-free rate was 94% (31/33). After 3 months of follow-up, the measures of pacing performance (sensing, impedance, and pacing threshold) either improved or were stable within the accepted range. Conclusions--In a prospective nonrandomized study, a completely self-contained, single-chamber leadless cardiac pacemaker has shown to be safe and feasible. The absence of a transvenous lead and subcutaneous pulse generator could represent a paradigm shift in cardiac pacing. [ABSTRACT FROM AUTHOR]

The MAGIC-AF Study. Background: Beyond pulmonary vein isolation (PVI), adjuvant ablation at the sites of complex fractionated atrial electrograms (CFAE) has been shown to improve the long-term success of catheter ablation of persistent atrial fibrillation (AF). However, this approach often requires extensive ablation due to the widespread distribution of CFAE within the left atrium. An optimal strategy would identify areas of CFAE which, when selectively targeted with ablation, result in AF termination with an acceptable long-term freedom from AF. It is possible that the intraprocedural administration of an antiarrhythmic drug may help accomplish this. Objective: The Modified Ablation Guided by Ibutilide Use in Chronic AF (MAGIC-AF) Study is an international multicenter prospective randomized double-blinded clinical trial assessing the utility of the intraprocedural administration of 0.25 mg of intravenous ibutilide before performing CFAE ablation. The primary efficacy endpoint of this study will be the freedom from AF at 1 year after a single procedure off antiarrhythmic agents. Safety endpoints will include procedural and radiofrequency ablation time as well as overall procedural complication rate. Methods: Patients undergoing a first ever catheter ablation procedure for persistent AF will be included. Individuals with hypertrophic cardiomyopathy, complex congenital heart disease including atrial septal defects, and ejection fraction <35% will be excluded from the study. All patients will first undergo PVI. Those patients who remain in AF will then be randomized in a 1:1 fashion to receive either 0.25 mg intravenous ibutilide or saline placebo followed by a CFAE based ablation strategy. Two hundred randomized patients will be enrolled in this study-100 in each study arm. Conclusion: The MAGIC-AF study will assess the utility of a combined pharmaco-ablative strategy in patients with persistent AF undergoing a CFAE based ablation strategy. [ABSTRACT FROM AUTHOR]

Ibutilide Guided CFAE Ablation. Introduction: While able to achieve clinical success, the current step-wise approach to persistent atrial fibrillation (AF) ablation requires considerable “substrate” ablation and frequently mandates multiple procedures to address consequent atrial tachycardias (ATs). An alternative strategy minimizing the amount of ablation while maintaining clinical success would be desirable. We hypothesize that intraprocedural administration of a low-dose antiarrhythmic drug (AAD) during AF will organize areas of passive activation and not affect areas critical to AF maintenance, thereby potentially minimizing the ablation lesion set. Methods and Results: Eleven patients (age = 55 ± 6 years; LA = 48 ± 15 mm; median AF duration = 3 years) with persistent AF undergoing catheter ablation were enrolled in this exploratory prospective observational study. After pulmonary vein (PV) isolation, a mean cycle length (mCL) map was created and areas with mCL <120 ms were considered to represent complex fractionated atrial electrograms (CFAE). Ibutilide (0.25–1.0 mg) was then administered and a second mCL map created. Ablation lesions were placed at CAFE sites identified after ibutilide administration. Activation and/or entrainment mapping was employed to address ATs. The endpoint of ablation was achieving sinus rhythm. The average LA mCL increased (146 vs 165 ms, P = 0.01) and the LA CFAE surface area decreased after ibutilide administration. Additional ablation organized AF to either sinus rhythm or AT in 10/11 (91%) patients. After a median follow up of 455 days, 8 of 11 (72%) patients were free from AF. Three patients underwent a repeat ablation procedure (average 1.27 ablations/patient). Conclusions: Ibutilide administration may organize atrial activity and facilitate AF termination during ablation while minimizing the ablation lesion set. (J Cardiovasc Electrophysiol, Vol. 21, pp. 608-616, June 2010) [ABSTRACT FROM AUTHOR]

Background: There is limited evidence on the long-term clinical benefits of catheter ablation in patients with persistent atrial fibrillation.Methods: PRECEPT was a prospective, multicenter, single-arm Food and Drug Administration-regulated investigational device exemption clinical study. Patients were followed up to 15 months after ablation. Outcomes included use of antiarrhythmic drugs, rate of cardioversions and cardiovascular hospitalization, Atrial Fibrillation Effect on Quality-of-Life score, and Canadian Cardiovascular Society Severity of Atrial Fibrillation score.Results: A total of 333 enrolled persistent atrial fibrillation patients underwent ablation. The cardioversion rate decreased by 83% at the 9- to 15-month follow-up. Antiarrhythmic drug utilization decreased by 69% at 12 to 15 months post-ablation. The Kaplan-Meier estimate of freedom from cardiovascular hospitalization was 84.2% (95% CI, 80.2%-88.2%) at 15 months. Consistent improvements in mean Atrial Fibrillation Effect on Quality-of-Life composite (+50.0) were seen at 6 months, sustained at 15 months, and exceeded the minimum clinically important difference. Improvements in Atrial Fibrillation Effect on Quality-of-Life scores were significantly better among participants without documented atrial arrhythmia recurrences. By Canadian Cardiovascular Society Severity of Atrial Fibrillation symptom classification, >80% of patients were asymptomatic (class 0) at 15 months post-ablation compared with only 0.7% at baseline.Conclusions: Contact force-guided radiofrequency ablation of persistent atrial fibrillation was associated with a significant decrease in antiarrhythmic drug use, cardioversion rate, and hospitalization. Clinically meaningful improvements in quality of life were observed in all patients. The majority of the patients (>80%) were asymptomatic at 15 months post-ablation. The positive clinical impact of improved quality of life and reduced health care utilization may help with shared decision-making in persistent atrial fibrillation treatment. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT02817776. [ABSTRACT FROM AUTHOR]