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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.
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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: 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 to 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 [IQR 19.5-27] and 21.52±8.61, respectively, with 35 being the highest score. Intra-observer variability was 0.986 (95% CI 0.944-1.028; p<0.001). The year of implementation did not influence the strength of the score (R2=-0.173; 95% CI -0.447-0.131, p=0.262), Correlation between SCD rate (R2=-0.76; 95% CI -0.492-0.367, p=0.742), bystander-initiated CPR (R2= -0.006; 95% CI -0.437-0.427, p=0.978), automatic external defibrillator use (R2= -0.125; 95% CI -0.528-0.324, p=0.590), or cardiovascular death rate (R2=-0.13; 95% CI -0.379-0.21, p=0.355) 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.
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BACKGROUND: The ability of computed tomography (CT) characteristics to predict the difficulty of transvenous lead extraction (TLE) is an evolving subject. OBJECTIVE: To identify CT characteristics associated with increased TLE difficulty. METHODS: All consecutive patients undergoing TLE at the University of California San Diego from January 2018 to February 2022 were analyzed, utilizing the UC San Diego Lead Extraction Registry. Patients underwent cardiac-gated chest CT scans with intravenous contrast; all scans were reviewed by a single radiologist. Lead extraction was performed per standard institutional protocol with the initial use of a laser sheath and crossover to a mechanical sheath as needed. Multivariable linear and logistic regression analyses were performed to identify predictors of individual lead-removal fluoroscopy time and mechanical sheath use, as markers of extraction difficulty. RESULTS: A total of 343 patients were analyzed. The mean age of the study population was 63.8 ± 15.4 years; 71% were male. The mean lead dwell-in duration was 8.6 ± 5.7 years. In multivariable linear regression analysis, venous occlusion detected on CT was independently associated with higher individual lead-removal fluoroscopy time (p = 0.004), when adjusting for clinical characteristics such as lead dwell time. In multivariable logistic regression analysis, calcification and venous occlusion were independently associated with a higher need for mechanical sheath use during TLE (odds ratio:5.08, p < 0.001, 95% CI: 2.54-10.46) and (odds ratio:3.72, p < 0.001, 95% CI: 1.89-7.35), respectively. CONCLUSION: In patients undergoing TLE, venous occlusion identified by chest CT is associated with increased fluoroscopy time. Patients with lead-associated calcification or venous occlusion detected by chest CT are each five and three times more likely to require crossover from laser to a mechanical sheath.
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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.
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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.
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Background: Pericardial effusion requiring percutaneous or surgical-based intervention remains an important complication of a leadless pacemaker implantation. Objective: The study sought to determine real-world prevalence, risk factors, and associated outcomes of pericardial effusion requiring intervention in leadless pacemaker implantations. Methods: The National Inpatient Sample and International Classification of Diseases-Tenth Revision codes were used to identify patients who underwent leadless pacemaker implantations during the years 2016 to 2020. The outcomes assessed in our study included prevalence of pericardial effusion requiring intervention, other procedural complications, and in-hospital outcomes. Predictors of pericardial effusion were also analyzed. Results: Pericardial effusion requiring intervention occurred in a total of 325 (1.1%) leadless pacemaker implantations. Patient-level characteristics that predicted development of a serious pericardial effusion included >75 years of age (odds ratio [OR] 1.38, 95% confidence interval [CI] 1.08-1.75), female sex (OR 2.03, 95% CI 1.62-2.55), coagulopathy (OR 1.50, 95% CI 1.12-1.99), chronic pulmonary disease (OR 1.36, 95% CI 1.07-1.74), chronic kidney disease (OR 1.53, 95% CI 1.22-1.94), and connective tissue disorders (OR 2.98, 95% CI 2.02-4.39). Pericardial effusion requiring intervention was independently associated with mortality (OR 5.66, 95% CI 4.24-7.56), prolonged length of stay (OR 1.36, 95% CI 1.07-1.73), and increased cost of hospitalization (OR 2.49, 95% CI 1.92-3.21) after leadless pacemaker implantation. Conclusion: In a large, contemporary, real-world cohort of leadless pacemaker implantations in the United States, the prevalence of pericardial effusion requiring intervention was 1.1%. Certain important patient-level characteristics predicted development of a significant pericardial effusion, and such effusions were associated with adverse outcomes after leadless pacemaker implantations.
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Youth and adult participation in sports continues to increase, and athletes may be diagnosed with potentially arrhythmogenic cardiac conditions. This international multidisciplinary document is intended to guide electrophysiologists, sports cardiologists, and associated health care team members in the diagnosis, treatment, and management of arrhythmic conditions in the athlete with the goal of facilitating return to sport and avoiding the harm caused by restriction. Expert, disease-specific risk assessment in the context of athlete symptoms and diagnoses is emphasized throughout the document. After appropriate risk assessment, management of arrhythmias geared toward return to play when possible is addressed. Other topics include shared decision-making and emergency action planning. The goal of this document is to provide evidence-based recommendations impacting all areas in the care of athletes with arrhythmic conditions. Areas in need of further study are also discussed.
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INTRODUCTION: Leadless pacemakers (LPM) have established themselves as the important therapeutic modality in management of selected patients with symptomatic bradycardia. To determine real-world utilization and in-hospital outcomes of LPM implantation since its approval by the Food and Drug Administration in 2016. METHODS: For this retrospective cohort study, data were extracted from the National Inpatient Sample database from the years 2016-2020. The outcomes analyzed in our study included implantation trends of LPM over study years, mortality, major complications (defined as pericardial effusion requiring intervention, any vascular complication, or acute kidney injury), length of stay, and cost of hospitalization. Implantation trends of LPM were assessed using linear regression. Using years 2016-2017 as a reference, adjusted outcomes of mortality, major complications, prolonged length of stay (defined as >6 days), and increased hospitalization cost (defined as median cost >34 098$) were analyzed for subsequent years using a multivariable logistic regression model. RESULTS: There was a gradual increased trend of LPM implantation over our study years (3230 devices in years 2016-2017 to 11 815 devices in year 2020, p for trend <.01). The adjusted mortality improved significantly after LPM implantation in subsequent years compared to the reference years 2016-2017 (aOR for the year 2018: 0.61, 95% CI: 0.51-0.73; aOR for the year 2019: 0.49, 95% CI: 0.41-0.59; and aOR for the year 2020: 0.52, 95% CI: 0.44-0.62). No differences in adjusted rates of major complications were demonstrated over the subsequent years. The adjusted cost of hospitalization was higher for the years 2019 (aOR: 1.33, 95% CI: 1.22-1.46) and 2020 (aOR: 1.69, 95% CI: 1.55-1.84). CONCLUSION: The contemporary US practice has shown significantly increased implantation rates of LPM since its approval with reduced rates of inpatient mortality.
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Estimulação Cardíaca Artificial , Bases de Dados Factuais , Custos Hospitalares , Tempo de Internação , Marca-Passo Artificial , Humanos , Marca-Passo Artificial/tendências , Marca-Passo Artificial/economia , Estados Unidos , Estudos Retrospectivos , Masculino , Feminino , Idoso , Resultado do Tratamento , Custos Hospitalares/tendências , Fatores de Tempo , Pessoa de Meia-Idade , Estimulação Cardíaca Artificial/tendências , Estimulação Cardíaca Artificial/economia , Estimulação Cardíaca Artificial/mortalidade , Estimulação Cardíaca Artificial/efeitos adversos , Tempo de Internação/tendências , Fatores de Risco , Idoso de 80 Anos ou mais , Bradicardia/terapia , Bradicardia/mortalidade , Bradicardia/diagnóstico , Frequência Cardíaca , Mortalidade Hospitalar/tendências , Desenho de Equipamento/tendênciasRESUMO
BACKGROUND: Leadless pacemakers have emerged as a promising alternative to transvenous pacemakers in patients with kidney disease. However, studies investigating leadless pacemaker outcomes and complications based on kidney dysfunction are limited. OBJECTIVE: The objective of this study was to evaluate the association of chronic kidney disease (CKD) and end-stage renal disease (ESRD) with inpatient complications and outcomes of leadless pacemaker implantations. METHODS: National Inpatient Sample and International Classification of Diseases, Tenth Revision codes were used to identify patients with CKD and ESRD who underwent leadless pacemaker implantations in the United States from 2016 to 2020. Study end points assessed included inpatient complications, outcomes, and resource utilization of leadless pacemaker implantations. RESULTS: A total of 29,005 leadless pacemaker placements were identified. Patients with CKD (n = 5245 [18.1%]) and ESRD (n = 3790 [13.1%]) were younger than patients without CKD and had higher prevalence of important comorbidities. In crude analysis, ESRD was associated with higher prevalence of major complications, peripheral vascular complications, and inpatient mortality. After multivariable adjustment, CKD and ESRD were associated with inpatient mortality (CKD: adjusted odds ratio [aOR], 1.62 [95% CI, 1.40-1.86]; ESRD: aOR, 1.38 [95% CI, 1.18-1.63]) and prolonged length of stay (CKD: aOR, 1.55 [95% CI, 1.46-1.66]; ESRD: aOR, 1.81 [95% CI 1.67-1.96]). ESRD was also associated with higher hospitalization costs (aOR, 1.63; 95% CI, 1.50-1.77) and major complications (aOR, 1.33; 95% CI, 1.13-1.57) after leadless pacemaker implantation. CONCLUSION: Approximately one-third of patients undergoing leadless pacemaker implantation had CKD or ESRD. CKD and ESRD were associated with greater length and cost of stay and inpatient mortality.
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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.
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Apêndice Atrial , Fibrilação Atrial , Fragilidade , Acidente Vascular Cerebral , Humanos , Masculino , Feminino , Apêndice Atrial/diagnóstico por imagem , Apêndice Atrial/cirurgia , Fragilidade/epidemiologia , Fragilidade/complicações , Estudos Retrospectivos , Sistema de Registros , Acidente Vascular Cerebral/etiologia , Resultado do TratamentoRESUMO
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.
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Apêndice Atrial , Fibrilação Atrial , Procedimentos Cirúrgicos Cardíacos , Acidente Vascular Cerebral , Humanos , Fibrilação Atrial/complicações , Fibrilação Atrial/cirurgia , Fibrilação Atrial/tratamento farmacológico , Apêndice Atrial/cirurgia , Resultado do Tratamento , Procedimentos Cirúrgicos Cardíacos/métodos , Acidente Vascular Cerebral/etiologia , Acidente Vascular Cerebral/prevenção & controle , Acidente Vascular Cerebral/tratamento farmacológico , Anticoagulantes/uso terapêuticoRESUMO
BACKGROUND: Catheter ablation improves outcomes in symptomatic atrial fibrillation (AF) patients. However, its safety and efficacy in the very elderly (≥80 years old) is not well described. HYPOTHESIS: Ablation of AF in the very elderly is safe and effective. METHODS: We performed a retrospective study of all patients who underwent catheter ablation enrolled in the University of California, San Diego AF Ablation Registry. The primary outcome was freedom from atrial arrhythmias on or off antiarrhythmic drugs (AADs). RESULTS: Of 847 patients, 42 (5.0%) were 80 years of age or greater with a median age of 81.5 (80-82.3) and 805 (95.0%) were less than 80 years of age with a median age of 64.4 (57.6-70.2). Among those who were ≥80 years old, 29 were undergoing de novo ablation (69.0%), whereas in the younger cohort, 518 (64.5%) were undergoing de novo ablation (p = .548). There were no statistically significant differences in fluoroscopy (p = .406) or total procedure times (p = .076), AAD use (p = .611), or procedural complications (p = .500) between groups. After multivariable adjustment, there were no statistically significant differences in recurrence of any atrial arrhythmias on or off AAD (adjusted hazard ratio [AHR]: 0.75; 95% confidence interval [CI]: 0.45-1.23; p = .252), all-cause hospitalizations (AHR: 0.86; 95% CI: 0.46-1.60; p = .626), or all-cause mortality (AHR: 4.48; 95% CI: 0.59-34.07; p = .147) between the very elderly and the younger cohort. CONCLUSION: In this registry analysis, catheter ablation of AF appears similarly effective and safe in patients 80 years or older when compared to a younger cohort.
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Fibrilação Atrial , Ablação por Cateter , Humanos , Idoso , Idoso de 80 Anos ou mais , Fibrilação Atrial/diagnóstico , Fibrilação Atrial/cirurgia , Fibrilação Atrial/complicações , Estudos Retrospectivos , Resultado do Tratamento , Antiarrítmicos/uso terapêutico , Sistema de Registros , Ablação por Cateter/efeitos adversos , Ablação por Cateter/métodos , RecidivaRESUMO
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.
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Background: Percutaneous left atrial appendage occlusion (LAAO) has proved to be a safer alternative for long-term anticoagulation; however, patients with a history of intracranial bleeding were excluded from large randomized clinical trials. Objective: The purpose of this study was to determine outcomes in atrial fibrillation (AF) patients with a history of intracranial bleeding undergoing percutaneous LAAO. Methods: National Inpatient Sample and International Classification of Diseases, Tenth Revision, codes were used to identify patients with AF who underwent LAAO during the years 2016-2020. Patients were stratified based on a history of intracranial bleeding vs not. The outcomes assessed in our study included complications, in-hospital mortality, and resource utilization. Result: A total of 89,300 LAAO device implantations were studied. Approximately 565 implantations (0.6%) occurred in patients with a history of intracranial bleed. History of intracranial bleeding was associated with a higher prevalence of overall complications and in-patient mortality in crude analysis. In the multivariate model adjusted for potential confounders, intracranial bleeding was found to be independently associated with in-patient mortality (adjusted odds ratio [aOR] 4.27; 95% confidence interval [CI] 1.68-10.82); overall complications (aOR 1.74; 95% CI 1.36-2.24); prolonged length of stay (aOR 2.38; 95% CI 1.95-2.92); and increased cost of hospitalization (aOR 1.28; 95% CI 1.08-1.52) after percutaneous LAAO device implantation. Conclusion: A history of intracranial bleeding was associated with adverse outcomes after percutaneous LAAO. These data, if proven in a large randomized study, can have important clinical consequences in terms of patient selection for LAAO devices.