Catheter ablation for atrial fibrillation in patients with prior left atrial appendage occlusion device.

BACKGROUND: The safety and efficacy of CA for AF and left-sided atrial arrhythmias (AA) in patients with left atrial appendage occlusion (LAAO) devices are lacking. METHODS: This is a single-center retrospective registry that included all patients with prior LAAO who underwent catheter ablation for AF or left-sided atrial arrhythmia from January 2020-January 2023. The primary outcomes were procedure-related complications, device-related complications, AA recurrence, and stroke. RESULTS: A total of 30 patients with prior LAAO were included in the analysis (mean age 75.1 ± 7.1 years old, 50% male, mean CHA2DS2-VASc score 4 ± 1.6, 46.7% paroxysmal AF, 73.3% had prior AF ablation, mean time to ablation 475 ± 365 days). 93.3% (n = 28) and 6.6% (n = 2) patients had ablation for AF (46.7% paroxysmal, 36.7% persistent, 10% long-standing persistent) and left-sided atrial tachycardia, respectively. 16.7% (n = 5) patients underwent ablation along the left atrial appendage ostium, and 3.3% (n = 1) underwent Vein of Marshall alcohol ablation. There were 3 (10%) peri-procedural complications (1 access hematoma and two pericardial effusions requiring intervention-none related to left atrial appendage ostium or alcohol ablation). During the mean follow-up of 440 ± 379 days, 40% (n = 12) patients had AA recurrence (91.6% AF, 8.3% atrial tachycardia), of which five patients needed repeat ablation, and two patients were readmitted for heart failure. There was no stroke or any device-related complications, including new peri-device leaks or device-related thrombosis in patients who had follow-up imaging studies (n = 11, 36.7%). CONCLUSION: Catheter ablation for AF (including VoM alcohol ablation) in patients with prior LAAO devices is feasible and safe with favorable outcomes.

Are High School Cardiopulmonary Resuscitation Education Mandates Working? Insights from a High School Survey on CPR Knowledge, Attitudes, and Readiness.

BACKGROUND: Cardiopulmonary Resuscitation (CPR) and automated external defibrillator (AED) use significantly improve the chances of survival after out-of-hospital cardiac arrest. Subsequently, state laws mandate training in CPR and AED use for high school graduation. However, training and its impact vary and must be better understood. OBJECTIVE: We assessed the current CPR training mandates and their impact. METHODS: We performed a nationwide, cross-sectional, survey-based observational study of high schoolers in 9th to 12th grades in all 50 states from 2020 to 2022 (NCT04493970), assessing basic demographics, attitudes, knowledge and skills, and willingness to learn CPR and AED use. RESULTS: We had an 8% response rate, resulting in 2,395 high school students surveyed. The mean age of respondents was 16.8±0.7 years, with 52.5% females. Of these, 86% underwent some form of training, and 25.1% had CPR training in the last year. Only 58.7% knew how to use an AED. Notably, 26.9% had previously witnessed CPR, and almost all (94%) realized the importance of learning CPR. Most respondents also believed recurrent and longitudinal would be beneficial. CONCLUSIONS: Surprisingly, only a small cohort of students do not undergo CPR training even when it is mandatory. The quality of this training appears to be inadequate to impart appropriate confidence and knowledge levels. This suggests a need for a significant overhaul of CPR training mandates across the United States.

Expert opinion on design and endpoints for studies on catheter ablation of atrial fibrillation.

INTRODUCTION: Catheter ablation of atrial fibrillation (AF) is frequently studied in randomized trials, observational and registry studies. The aim of this expert opinion is to provide guidance for clinicians and industry regarding the development of future clinical studies on catheter ablation of AF, implement lessons learned from previous studies, and promote a higher degree of consistency across studies. BACKGROUND: Studies on catheter ablation of AF may benefit from well-described definitions of endpoints and consistent methodology and documentation of outcomes related to efficacy, safety and cost-effectiveness. The availably of new, innovative technologies warrants further consideration about their application and impact on study design and the choice of endpoints. Moreover, recent insights gained from AF ablation studies suggest a reconsideration of some methodological aspects. METHODS: A panel of clinical experts on catheter ablation of AF and designing and conducting clinical studies developed an expert opinion on the design and endpoints for studies on catheter ablation of AF. Discussions within the expert panel with the aim to reach consensus on predefined topics were based on outcomes reported in the literature and experiences from recent clinical trials. RESULTS: A comprehensive set of recommendations is presented. Key elements include the documentation of clinical AF, medication during the study, repeated ablations and their effect on endpoint assessments, postablation blanking and the choice of rhythm-related and other endpoints. CONCLUSION: This expert opinion provides guidance and promotes consistency regarding design of AF catheter ablation studies and identified aspects requiring further research to optimize study design and methodology. CONDENSED ABSTRACT: Recent insights from studies on catheter ablation of atrial fibrillation (AF) and the availability of new innovative technologies warrant reconsideration of methodological aspects related to study design and the choice and assessment of endpoints. This expert opinion, developed by clinical experts on catheter ablation of AF provides a comprehensive set of recommendations related to these methodological aspects. The aim of this expert opinion is to provide guidance for clinicians and industry regarding the development of clinical studies, implement lessons learned from previous studies, and promote a higher degree of consistency across studies.

Application repetition and electrode-tissue contact result in deeper lesions using a pulsed-field ablation circular variable loop catheter.

AIMS: Pulsed-field ablation (PFA) is a novel, myocardial-selective, non-thermal ablation modality used to target cardiac arrhythmias. Although prompt electrogram (EGM) signal disappearance is observed immediately after PFA application in the pulmonary veins, whether this finding results in adequate transmural lesions is unknown. The aim of this study is to check whether application repetition and catheter-tissue contact impact lesion formation during PFA. METHODS AND RESULTS: A circular loop PFA catheter was used to deliver repeated energy applications with various levels of contact force. A benchtop vegetal potato model and a beating heart ventricular myocardial model were utilized to evaluate the impact of application repetition, contact force, and catheter repositioning on contiguity and lesion depth. Lesion development occurred over 18 h in the vegetal model and over 6 h in the porcine model. Lesion formation was found to be dependent on application repetition and contact. In porcine ventricles, single and multiple stacked applications led to a lesion depth of 3.5 ± 0.7 and 4.4 ± 1.3 mm, respectively (P = 0.002). Furthermore, the greater the catheter-tissue contact, the more contiguous and deeper the lesions in the vegetal model (1.0 ± 0.9 mm with no contact vs. 5.4 ± 1.4 mm with 30 g of force; P = 0.0001). CONCLUSION: Pulsed-field ablation delivered via a circular catheter showed that both repetition and catheter contact led independently to deeper lesion formation. These findings indicate that endpoints for effective PFA are related more to PFA biophysics than to mere EGM attenuation.

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.

Catheter-related and clinical complications associated with QDOT MICROTM Ablation Catheter.

INTRODUCTION: The QDOT MICROTM Ablation Catheter is a next-generation ablation catheter that allows for high-power ablation up to 90 watts. METHODS: We aimed to assess AE associated with the QDOT MICROTM catheter using the MAUDE database. A MAUDE database search was conducted on May 25, 2024, to capture all AEs (since FDA approval) associated with this ablation catheter. RESULTS: A total of 302 AEs from November 23, 2022, to April 30, 2024, were reported including 148 (49%) catheter-related issues and 154 (51%) clinical complications. Among the catheter-related issues, physical catheter damage (74.3%, n = 110) was most common, followed by communication or display issue (10.8%, n = 16), irrigation issue (9.5%, n = 14), signal issue or artifact (3.4%, n = 5), and inaccurate temperature measurement (2.0%, n = 3). Regarding clinical complications, the most common AE was pericardial effusion (43.5%, n = 67), followed by char formation (11.7%, n = 18), catheter thrombosis (7.1%, n = 11), stroke (7.1%, n = 11), pericarditis (7.1%, n = 11), esophageal complications (6.5%, n = 10), phrenic nerve palsy (3.9%, n = 6), cardiac arrest (3.9%, n = 6), significant AV block (3.9%, n = 6), pulmonary vein stenosis (3.2%, n = 5), coronary artery spasm (1.3%, n = 2), and pulmonary embolism (0.6%, n = 1). There were 11 deaths (five related to esophageal complications, five related to cardiac arrest, and one related to pericardial effusion with cardiac tamponade). CONCLUSION: As high-power ablation strategy with novel ablation catheters is becoming more widely utilized, operators must be aware of potential catheter-related issues and clinical complications that may arise. More data are needed to further evaluate risks of these complications to improve the catheter's safety and efficacy.

Management of anesthesia for procedures in the cardiac electrophysiology laboratory.

The complexity of cardiac electrophysiology procedures has increased significantly during the past 3 decades. Anesthesia requirements of these procedures can differ on the basis of patient- and procedure-specific factors. This manuscript outlines various anesthesia strategies for cardiac implantable electronic devices and electrophysiology procedures, including preprocedural, procedural, and postprocedural management. A team-based approach with collaboration between cardiac electrophysiologists and anesthesiologists is required with careful preprocedural and intraprocedural planning. Given the recent advances in electrophysiology, there is a need for specialized cardiac electrophysiology anesthesia care to improve the efficacy and safety of the procedures.

Contemporary Management of Cardiac Implantable Electronic Device Infection: The American College of Cardiology COGNITO Survey.

Background: Cardiac implantable electronic devices (CIEDs) infection remains a serious complication, causing increased morbidity and mortality. Early recognition and escalation to definitive therapy including extraction of the infected device often pose challenges. Objectives: The purpose of this study was to assess U.S.-based physicians current practices in diagnosing and managing CIED infections and explore potential extraction barriers. Methods: An observational survey was performed by the American College of Cardiology including U.S. physicians managing CIEDs from February to March 2022. Sampling techniques and screener questions determined eligibility. The survey featured questions on knowledge and experience with CIED infection patients and case scenarios. Results: Of 387 physicians completing the survey (20% response rate), 49% indicated familiarity with current guidelines regarding CIED infection. Electrophysiologists (EPs) (91%) were more familiar with these guidelines, compared to non-EP cardiologists (29%) and primary care physicians (23%). Only 30% of physicians specified that their institution had guideline-based protocols in place for managing patients with CIED infection. When presented with pocket infection cases, approximately 89% of EPs and 50% of non-EP cardiologists would follow guideline recommendation to do complete CIED system removal, while 70% of primary care physicians did not recommend guideline-directed treatment. Conclusions: There are gaps in familiarity of guidelines as well as the knowledge in practical management of CIED infection with non-extracting physicians. Most institutions lack a definite pathway. Addressing discrepancies, including guideline education and streamlining care or referral pathways, will be a key factor to bridging the gap and improving CIED infection patient outcomes.

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.

Feasibility of Amulet occluder implantation after failed left atrial appendage occlusion attempt: Insights from the EMERGE LAA postapproval study.

BACKGROUND: Although expertise in left atrial appendage occlusion (LAAO) has grown, certain intricate anatomies may pose challenges, rendering them unsuitable for LAAO with the selected device. OBJECTIVE: This analysis aimed to characterize outcomes of patients with prior failed percutaneous LAAO procedures who underwent a subsequent attempt with an Amulet occluder in the EMERGE LAA postapproval study. METHODS: Patients enrolled in the National Cardiovascular Data Registry LAAO Registry who had an Amulet occluder implantation attempt between Food and Drug Administration approval (August 14, 2021) and June 30, 2023, were evaluated. A safety end point through 7 days or hospital discharge (whichever was later) and major adverse events through 45 days were reported. RESULTS: A total of 8591 patients underwent attempted Amulet occluder implantation, of whom 244 patients had prior failed LAAO. Implantation success was 88.9% and 96.2% in patients with prior failed LAAO and index LAAO, respectively (P < .001). The safety composite end point was low, occurring in 1.6% and 0.8% of patients with prior failed LAAO and index LAAO, respectively (P = .148). Any major adverse event through 45 days occurred in 7.4% and 6.3% of prior failed LAAO and index LAAO patient cohorts, respectively (P = .497); most adverse events were similar between the groups (P > .05). At 45 days, peridevice leak ≤3 mm was achieved in >90% of patients in either group. CONCLUSION: A high degree of implantation success with a low rate of adverse events can be achieved with the Amulet occluder. The findings imply that the dual occlusive mechanism Amulet occluder facilitates successful closure, even in challenging anatomic scenarios.

Pulmonary Vein Isolation With or Without Left Atrial Appendage Ligation in Atrial Fibrillation: The aMAZE Randomized Clinical Trial.

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