Feasibility, safety, and efficacy of a novel external compression vascular closure device: The LockeT® study.

INTRODUCTION: Hemostasis following large-bore femoral vein access remains a challenge. Manual compression has been the standard of care but requires bedside staff, prolonged bed rest, and longer length of stay. The LockeT is an external compression device that attempts to address these issues while achieving venous hemostasis. OBJECTIVES: We evaluate postprocedural hemostasis and vascular closure outcomes after using LockeT following cardiac electrophysiologic procedures. METHODS: We performed a single-center, observational study of patients who underwent vascular closure for electrophysiology procedures using LockeT. Postprocedural outcomes were subsequently analyzed. RESULTS: We studied 102 patients (N) for whom LockeT was used to close 182 separate vascular access sites (n). Common procedures were atrial fibrillation ablation (56.9%, N = 58) and left atrial appendage occlusion (28.4%, N = 29). Most often, 8-Fr [48.3% (n = 126)], 11-Fr [27.2% (n = 71)], and 8.5-Fr [16.9% (n = 44)] sheaths were used, with an average procedure time of 82.1 ± 29.4 min. Hemostasis was achieved in 97.8% (n = 187) of all LockeT cases. Time to ambulation and discharge were 3.93 ± 1.10 h and 8.1 ± 4.4 h, respectively. No major complications were noted. Postprocedurally, 52% (N = 53) of patients were discharged on the same day. There were no differences in hemostasis (p = .859) or ambulation times (p = .202) between procedure types. CONCLUSION: The LockeT can effectively close venous access sites with no major complications.

Outcomes of hybrid surgical ablation and concomitant left atrial appendage exclusion in long-standing persistent atrial fibrillation.

INTRODUCTION: Management of patients with long-standing persistent atrial fibrillation (LSPAF) presents a clinical challenge. Hybrid convergent ablation has been shown to have superior efficacy compared to endocardial-only ablation. However, data on concomitant left atrial appendage (LAA) management along with hybrid ablation is sparse. METHODS: We aimed to evaluate the effectiveness of concomitant hybrid convergent ablation and LAA clipping in patients with LSPAF. We conducted a retrospective analysis of all patients with LSPAF who underwent hybrid surgical ablation with LAA clipping at our institution. The primary endpoint was a recurrence of atrial arrhythmias at 12 months. Further, the durability of surgical left atrial posterior wall ablation was examined during the endocardial catheter ablation using standing electrophysiological criteria. RESULTS: A total of 79 patients were included. Mean age was 63.5 ± 9.6 years, and 71% were males. LAA clipping was performed in 99% of patients. The mean time between the surgical and endocardial stages of the procedure was 2.6 ± 1.7 months. Persistent posterior wall activity was observed in 34.2% (n = 27/79) patients during the endocardial phase of the procedure. Cardiac implantable electronic device was used in 74% of patients for monitoring of recurrence of atrial fibrillation (AF). The primary effectiveness of AF freedom at 12 months was 73.8% (45/61). Over a 12-month follow-up period, 11.4% (9/79) of patients required repeat catheter ablation, of which 88.9% (8/9) had evidence of persistent posterior wall activity. CONCLUSION: Concomitant hybrid convergent ablation and LAA exclusion with an atrial clip provides reasonable long-term AF-free survival in patients with LSPAF. Persistent posterior wall activity is seen commonly in patients presenting with recurrent AF following hybrid convergent AF ablation.

A novel scoring system and correlative analysis of the strength and effectiveness of nationwide high school cardiopulmonary resuscitation mandates: Insights from a high school CPR study.

BACKGROUND: Numerous states have introduced cardiopulmonary resuscitation (CPR) training mandates for high school students and staff to prevent sudden cardiac death (SCD). However, the content and implementation of these mandates vary substantially. Furthermore, a comprehensive and objective assessment of these mandates and their impact is lacking. OBJECTIVE: We aimed to conduct a thorough evaluation of CPR training mandates across the United States. METHODS: We developed a novel scoring system based on proposed CPR standards, training and certification requirements, and legislative action to assess current mandates. This was used to rate the CPR mandates across all 50 states and the District of Columbia. Mandate scores were then compared with available real-world registry data as a surrogate for efficacy from 2018 to 2021. RESULTS: State CPR mandate scores ranged from 0 to 47, with a higher score indicating more robust mandates. The median and mean scores were 24 (interquartile range, 19.5-27) and 21.52 ± 8.61, respectively, with 35 being the highest score. Intraobserver variability was 0.986 (95% CI, 0.944-1.028; P < .001). The year of implementation did not influence the strength of the score (R2 = -0.173; 95% CI, -0.447 to 0.131; P = .262). Correlation with SCD rate (R2 = -0.76; 95% CI, -0.492 to 0.367; P = .742), bystander-initiated CPR (R2 = -0.006; 95% CI, -0.437 to 0.427; P = .978), automated external defibrillator use (R2 = -0.125; 95% CI, -0.528 to 0.324; P = .590), and cardiovascular death rate (R2 = -0.13; 95% CI, -0.379 to 0.21; P = .355) failed to reach statistical significance. CONCLUSION: Modest scoring consistency highlights the need for robust, standardized CPR requirements to potentially mitigate SCD. This study lays the groundwork for evidence-informed policy development in this area.

Impact of an Organized Treatment Pathway on Management of Atrial Fibrillation: The ER2EP Study.

Background: Atrial fibrillation (AF) is the most common arrhythmia reported worldwide. There is significant heterogeneity in AF care pathways for a patient seen in the emergency room, impacting access to guideline-driven therapies. Objectives: The purpose of this study was to compare the difference in AF outcomes between those treated with an organized treatment pathway vs routine-care approach. Methods: The emergency room to electrophysiology service study (ER2EP) is a multicenter, prospective observational registry (NCT04476524) enrolling patients with AF from sites where a pathway for management of AF was put in place compared to sites where a pathway was not in place within the same health system and the same physicians providing services at all sites. Multivariable regression modeling was performed to identify predictors of clinical outcomes. Beta coefficient or odds ratio was reported as appropriate. Results: A total of 500 patients (ER2EP group, n = 250; control group, n = 250) were included in the study. The mean age was 73.4 ± 12.9 years, and 52.2% were males. There was a statistically significant difference in primary endpoint [time to ablation (56 ± 50.9 days vs 183.3 ± 109.5 days; P < 0.001), time to anticoagulation initiation (2.1 ± 1.6 days vs 19.7 ± 35 days, P < 0.001), antiarrhythmic drug initiation (4.8 ± 7.1 days vs 24.7 ± 44.4 days, P < 0.001) compared to the control group, respectively. As such, this resulted in reduced length of stay in the ER2EP group compared to the control group (2.4 ± 1.4 days vs 3.23 ± 2.5 days, P = 0.002). Conclusions: This study provides evidence that having an organized pathway from the emergency department for AF patients involving electrophysiology services can improve early access to definitive therapies and clinical outcomes.

A case of short QT-interval postventricular arrhythmia arrest from Torsade De Pointes, a new phenotype, or the result of tachycardia-mediated imbalance.

INTRODUCTION: We report the case of an 18-year-old female with recurrent syncope that was discovered to have congenital long QT syndrome (LQTS) and episodes of a transiently short QT interval after spontaneous termination of polymorphic ventricular tachycardia. METHODS & RESULTS: A cardiac event monitor revealed a long QT interval and initiation of polymorphic ventricular tachycardia by a premature ventricular complex on the preceding T-wave. After 1 minute of ventricular fibrillation, her arrhythmia spontaneously terminated with evidence of a short QT interval. CONCLUSIONS: A transient, potentially artificial, short QT interval following Torsades de Pointes can occur in patients with LQTS.

Frailty and associated outcomes in patients undergoing percutaneous left atrial appendage occlusion: findings from the NCDR LAAO registry.

BACKGROUND: Frailty is associated with significant morbidity and mortality and may have clinical implications in an advanced age population with atrial fibrillation undergoing left atrial appendage occlusion (LAAO). We sought to develop a novel frailty scale to predict worse outcomes in patients undergoing LAAO. METHODS: Patients in the NCDR LAAO Registry between 2016 and 2021 receiving percutaneous LAAO devices were categorized as non-frail (0 points), pre-frail (1-3 points), or frail (4-5 points) based on a 5-point scale representing multiple domains of frailty: hemoglobin <13.0 g/dL in male, <12.0 g/dL in female; creatinine ≥1.2 mg/dL; albumin <3.5 g/dL; body mass index <20 kg/m2; and increased risk of falls. RESULTS: Of 57,728 patients, 44,360 (76.8%) were pre-frail and 7693 (13.3%) were frail. Compared to non-frail, pre-frail and frail patients were older, had a higher burden of co-morbidities, and more disability based on the Modified Rankin Scale. Compared to non-frail patients after adjustment, frail patients were at higher risk of in-hospital major complication (OR 1.29, 95% 1.02-1.62, p = 0.01), any complication (OR 1.29, 95% CI 1.09-1.52, p = 0.0005), and death (OR 5.79, 95% CI 1.75-19.17, p = 0.001), while no difference was observed in pre-frail patients. At 45-day follow-up, there was no difference in the risk of complications in frail patients as compared to non-frail, although mortality was significantly higher (OR 3.01, 95% CI 1.97-4.85, p < 0.0001). CONCLUSION: A simple and practical frailty scale accurately predicts adverse events in patients undergoing LAAO. The 13% of patients considered frail were at significantly higher risk of in-hospital adverse events and 45-day mortality.

Bilateral Cardiac Sympathetic Denervation for Refractory Multifocal Premature Ventricular Contractions in Patients With Nonischemic Cardiomyopathy.

BACKGROUND: Bilateral cardiac sympathetic denervation (BCSD) for refractory life-threatening ventricular arrhythmias is a neuromodulatory intervention targeting sympathetically driven focal or re-entrant ventricular arrhythmias. OBJECTIVES: This study sought to provide a more complete and successful option for intervention in patients in whom premature ventricular contraction (PVC) ablation is not feasible or has been unsuccessful. METHODS: A total of 43 patients with >5% PVC burden and concomitant nonischemic cardiomyopathy (NICM) who previously failed medical and ablation therapies were referred for BCSD. All patients underwent bilateral video-assisted thoracoscopic surgical approach with T1-T4 sympathectomy. Primary effectiveness endpoints were postprocedural PVC burden resolution, improvement in left ventricular ejection fraction (LVEF), and cessation of antiarrhythmic drugs (AADs). Safety endpoints included peri- and postprocedural complications. Outcomes were assessed over a 1-year follow-up period. RESULTS: Among the 43 patients who underwent BCSD, the mean age was 52.3 ± 14.7 years, 69.8% of whom were male patients. Presenting mean LVEF was 38.7% ± 7.8%, and PVC burden was 23.7% ± 9.9%. There were significant reductions in PVC burden postprocedurally (1.3% ± 1.1% post-BCSD, compared with 23.7% ± 9.9% pre-BCSD, P < 0.001) and improvements in LVEF (46.3% ± 9.5% post-BCSD, compared with 38.7% ± 7.8% pre-BCSD, P < 0.001). The rate of ICD therapies decreased from 81.4% (n = 35) to 11.6% (n = 5) (P < 0.001), leading to a significant reduction in use of AADs (100.0% to 11.6%, P < 0.001) and improvement in mean NYHA functional class (2.5 ± 0.5 to 1.4 ± 0.2, P < 0.001). Major intraoperative complications were seen in 4.7% of patients (hemothorax and chylothorax). Of the patients, 81.4% (n = 35) experienced no mortality or major complications over a 1-year follow-up period, with the remaining still within their first year postprocedure. CONCLUSIONS: BCSD is effective for the management of refractory PVCs and ventricular tachycardia who have failed previous ablation therapy.

Poorer outcomes associated with more invasive lead management strategies for Abbott Riata® leads: a large, multicenter experience.

BACKGROUND: Over 100,000 Abbott Riata® were implanted in the United States before they were recalled in 2010. There are still a significant number of Abbott Riata® leads in use, and it is unclear how these leads should be managed at the time of generator change or lead malfunction. Although data comparing both Sprint Fidelis® and Abbott Riata® leads in this setting is available, there are no multicenter comparative studies of outcomes for various lead management strategies, including lead extraction (LE), lead abandonment/revision (LA), and generator change (GC) only at the time of device at elective replacement interval (ERI) for Abbott Riata® leads. METHODS: A retrospective, multicenter study was undertaken to compare short-term outcomes (major complications-MC, death, extended or re-hospitalizations within 60 days-RH, lead malfunction-LM) and total outcomes (short-term outcomes & lead malfunction during follow-up) of patients with Riata® leads undergoing LE, LA, or GC. RESULTS: 152 patients (65 ± 13 years, 68% male) were followed for a mean 33 ± 30 months following intervention. Out of 166 procedures, 13 patients underwent LE, 16 patients underwent LA, and 137 patients underwent GC. There was 1 major complication in each group, yielding an event rate of 7.7% for LE, 6.3% for LA, and 0.7% for GC cohorts. There were significantly more short-term and total adverse outcomes in the group of patients getting LE and LA versus GC only (38.5% & 31.3% vs 7.3%, P < 0.001). Total Riata® lead dwell time follow-up was 17,067 months. A total of 3 Riata® lead malfunctions were noted during long-term follow-up. Inappropriate shocks were similar between LE 7.7% (1/13), LA 6.3% (1/16). and GC 11.0% (4/136); P = 0.57. CONCLUSIONS: There were more short-term and total adverse outcomes in more invasive management strategies (LE and LA) versus GC alone. The failure rate of Riata® leads was substantially lower compared to previous reports. Therefore, we recommend only performing battery exchange when a device with an active Riata® lead is at ERI, unless there is malfunction of the Riata® lead noted on testing. There were significantly more short-term adverse outcomes in the lead extraction (5/13) and lead abandonment/revision (5/16) groups than the generator only (8/137) group (P < 0.001). GIB - Gastrointestinal bleed, CHF - congestive heart failure, NSTEMI - non-ST elevation MI.

Left Atrial Appendage Closure with Watchman vs Amulet Devices: Similarities and Differences.

PURPOSE OF REVIEW: Left atrial appendage closure (LAAC) has shown to be non-inferior to oral anticoagulation (OAC) for non-valvular atrial fibrillation (AF). LAAC is now becoming a leading method for stroke prophylaxis in patients who have atrial fibrillation and are unable to tolerate OAC. There are currently two FDA-approved endocardial closure devices, namely, the Watchman FLX and Amplatzer Amulet. RECENT FINDINGS: Current data highlights that both devices offer similar efficacy and safety for LAAC. While the two devices differ in terms of intraprocedural complication rates, they offer similar short- to long-term outcomes in regard to peri-device leaks, device-related thrombosis, and mortality. With similar risk and safety profiles, both devices are indicated for patients who are unable to tolerate OAC. Newer clinical studies are directed to establish the efficacy of both devices as the primary method for stroke prevention in AF as an alternate to OAC.

Risk of Arrhythmic Death in Patients With Nonischemic Cardiomyopathy: JACC Review Topic of the Week.

Nonischemic cardiomyopathy (NICM) is common and patients are at significant risk for early mortality secondary to ventricular arrhythmias. Current guidelines recommend implantable cardioverter-defibrillator (ICD) therapy to decrease sudden cardiac death (SCD) in patients with heart failure and reduced left ventricular ejection fraction. However, in randomized clinical trials comprised solely of patients with NICM, primary prevention ICDs did not confer significant mortality benefit. Moreover, left ventricular ejection fraction has limited sensitivity and specificity for predicting SCD. Therefore, precise risk stratification algorithms are needed to define those at the highest risk of SCD. This review examines mechanisms of sudden arrhythmic death in patients with NICM, discusses the role of ICD therapy and treatment of heart failure for prevention of SCD in patients with NICM, examines the role of cardiac magnetic resonance imaging and computational modeling for SCD risk stratification, and proposes new strategies to guide future clinical trials on SCD risk assessment in patients with NICM.

Lower-adherence direct oral anticoagulant use is associated with increased risk of thromboembolic events than warfarin.

BACKGROUND: Real-world data have suggested inconsistent adherence to oral anticoagulation for thromboembolic event (TE) prevention in patients with Non valvular atrial fibrillation (NVAF), yet it remains unclear if event risk is elevated during gaps of non-adherence. OBJECTIVE: To compare difference in outcomes between direct oral anticoagulant (DOAC) and warfarin based on adherence to the therapy in patients with NVAF. METHODS: Using the MarketScan claims data, patients receiving prescription of warfarin or a DOAC for NVAF from January 2015 to June 2016 were included. Outcomes included hospitalization for TE (ischemic stroke or systemic embolism), hemorrhagic stroke, stroke of any kind, and major bleeding. Event rates were reported for warfarin and DOACs at a higher-adherence proportion of days covered (PDC > 80%) and lower-adherence (PDC 40-80%). RESULTS: The cohort included 83,168 patients prescribed warfarin (51% [n = 42,639]) or DOAC (49% [n = 40,529]). Lower adherence occurred in 36% (n = 15,330) of patients prescribed warfarin and 26% (n = 10,956) prescribed DOAC. As compared to higher-adherence warfarin after multivariable adjustment, the risk of TE was highest in lower-adherence DOAC (HR 1.26; 95% CI, 1.14-1.33), and lowest in higher-adherence DOAC (HR, 0.93; 95% CI, 0.88-0.99). There was a significantly higher risk of hemorrhagic stroke and stroke of any kind in the lower-adherence groups. Major bleeding was more common with lower-adherence DOAC (HR, 1.43, 95% CI, 1.35-1.52) and lower-adherence warfarin (HR, 1.32, 95% CI, 1.26-1.39). CONCLUSIONS: In this large real-world study, low adherence DOAC was associated with higher risk of TE events as compared to high and low adherence warfarin.

Data deluge from remote monitoring of cardiac implantable electronic devices and importance of clinical stratification.

Background: Remote monitoring (RM) has been accepted as a standard of care for follow-up of patients with cardiac implantable electronic devices (CIEDs). However, the resulting data deluge poses major challenge to device clinics. Objective: This study aimed to quantify the data deluge from CIED and stratify these data based on clinical relevance. Methods: The study included patients from 67 device clinics across the United States being remotely monitored by Octagos Health. The CIEDs included implantable loop recorders, pacemakers, implantable cardioverter-defibrillators, cardiac resynchronization therapy defibrillators, and cardiac resynchronization therapy pacemakers. Transmissions were either dismissed before reaching the clinical practice if they were repetitive or redundant or were forwarded if they were either clinically relevant or actionable transmission (alert). The alerts were further classified as level 1, 2, or 3 based on clinical urgency. Results: A total of 32,721 patients with CIEDs were included. There were 14,465 (44.2%) patients with pacemakers, 8381 (25.6%) with implantable loop recorders, 5351 (16.4%) with implantable cardioverter-defibrillators, 3531 (10.8%) with cardiac resynchronization therapy defibrillators, and 993 (3%) with cardiac resynchronization therapy pacemakers. Over a period of 2 years of RM, 384,796 transmissions were received. Of these, 220,049 (57%) transmissions were dismissed, as they were either redundant or repetitive. Only 164,747 (43%) transmissions were transmitted to the clinicians, of which only 13% (n = 50,440) had clinical alerts, while 30.6% (n = 114,307) were routine transmissions. Conclusion: Our study shows that data deluge from RM of CIEDs can be streamlined by utilization of appropriate screening strategies that will enhance efficiency of device clinics and provide better patient care.

Long-Term Imaging and Clinical Outcomes of Surgical Left Atrial Appendage Occlusion With AtriClip.

Surgical left atrial appendage (LAA) occlusion with an AtriClip (AtriCure, West Chester, Ohio) is frequently performed for stroke prophylaxis in patients with atrial fibrillation (AF). We conducted a retrospective analysis of all patients with long-standing persistent AF who underwent hybrid convergent ablation and LAA clipping. Contrast-enhanced cardiac computed tomography was performed at 3 to 6 months after LAA clipping to assess the degree of complete closure and the residual LAA stump. A total of 78 patients (64 ± 10 years, 72% male) underwent LAA clipping as part of hybrid convergent AF ablation, from 2019 to 2020. Median size of AtriClip used was 45 mm. Mean LA size was 4.6 ± 1 cm. At 3-to-6 months follow-up computed tomography, 46.2% of patients (n = 36) had a residual stump proximal to the deployed LAA clip. Mean depth of residual stump was 3.95 ± 5.5 mm, with 19% of patients (n = 15) having a stump depth of ≥10 mm and 1 patient requiring more endocardial LAA closure owing to large stump depth. During 1-year follow-up, 3 patients developed stroke; device leak of 6 mm was noted in 1 patient; and none of the patients had a thrombus proximal to the clip. In conclusion, high incidence of residual LAA stump was observed with AtriClip. Larger studies with long-term follow-up are needed to better assess the thromboembolic implications of a residual stump after AtriClip placement.

Multidisciplinary Critical Care Management of Electrical Storm: JACC State-of-the-Art Review.

Electrical storm (ES) reflects life-threatening cardiac electrical instability with 3 or more ventricular arrhythmia episodes within 24 hours. Identification of underlying arrhythmogenic cardiac substrate and reversible triggers is essential, as is interrogation and programming of an implantable cardioverter-defibrillator, if present. Medical management includes antiarrhythmic drugs, beta-adrenergic blockade, sedation, and hemodynamic support. The initial intensity of these interventions should be matched to the severity of ES using a stepped-care algorithm involving escalating treatments for higher-risk presentations or recurrent ventricular arrhythmias. Many patients with ES are considered for catheter ablation, which may require the use of temporary mechanical circulatory support. Outcomes after ES are poor, including frequent ES recurrences and deaths caused by progressive heart failure and other cardiac causes. A multidisciplinary collaborative approach to the management of ES is crucial, and evaluation for heart transplantation or palliative care is often appropriate, even for patients who survive the initial episode.

Feasibility and Safety of Intravenous Sotalol Loading in Adult Patients With Atrial Fibrillation (DASH-AF).

BACKGROUND: Inpatient initiation of sotalol is recommended owing to its proarrhythmic effects. OBJECTIVES: The DASH-AF (Feasibility and Safety of Intravenous Sotalol Administered as a Loading Dose to Initiate Oral Sotalol Therapy in Adult Patients With Atrial Fibrillation) trial evaluates the safety and feasibility of intravenous (IV) sotalol, achieving a steady state with maximum QTc prolongation within 6 hours instead of the traditional 5-dose inpatient oral (PO) titration. METHODS: DASH-AF is a prospective, nonrandomized, multicenter, open-label trial consisting of patients who underwent IV sotalol loading dose to initiate rapid oral therapy for atrial arrhythmias. IV dose was calculated based on the target oral dose as indicated by baseline QTc and renal function. Patients' QTc (in sinus) was measured via electrocardiography at 15-minute intervals and after IV loading completion. Patients were discharged 4 hours after first oral dose. All patients were monitored via mobile cardiac outpatient telemetry for 72 hours. The control group was composed of patients admitted for the traditional 5 PO doses. Safety outcomes were assessed in both groups. RESULTS: A total of 120 patients from 3 centers were enrolled from 2021 to 2022 in the IV loading group (compared with type of AF- and renal function-matched patients in the conventional PO loading cohort). This study demonstrated no significant change in ΔQTc in both groups, with a significantly lower number of patients requiring dose adjustment in the IV arm compared with the PO arm (4.1% vs 16.6%; P = 0.003). This led to potential cost savings of up to $3,500.68 per admission. CONCLUSIONS: The DASH-AF trial shows that rapid IV sotalol loading in atrial fibrillation/flutter patients for rhythm control is feasible and safe compared with conventional oral loading with significant cost reduction. (Feasibility and Safety of Intravenous Sotalol Administered as a Loading Dose to Initiate Oral Sotalol Therapy in Adult Patients With Atrial Fibrillation [DASH-AF]; NCT04473807).