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BACKGROUND: The comparative real-world outcomes of older patients with atrial fibrillation (AF) treated with anticoagulation compared with left atrial appendage occlusion (LAAO) may be different from those in clinical trials because of differences in anticoagulation strategies and patient demographics, including a greater proportion of women. We sought to compare real-world outcomes between older patients with AF treated with anticoagulation and those treated with LAAO by sex. METHODS: Using Medicare claims data from 2015 to 2019, we identified LAAO-eligible beneficiaries and divided them into sex subgroups. Patients receiving LAAO were matched 1:1 to those receiving anticoagulation alone through propensity score matching. The risks of mortality, stroke or systemic embolism, and bleeding were compared between matched groups with adjustment for potential confounding characteristics in Cox proportional hazards models. RESULTS: Among women, 4085 LAAO recipients were matched 1:1 to those receiving anticoagulation; among men, 5378 LAAO recipients were similarly matched. LAAO was associated with a significant reduction in the risk of mortality for women and men (hazard ratio [HR], 0.509 [95% CI, 0.447-0.580]; and HR, 0.541 [95% CI, 0.487-0.601], respectively; P<0.0001), with a similar finding for stroke or systemic embolism (HR, 0.655 [95% CI, 0.555-0.772]; and HR, 0.649 [95% CI, 0.552-0.762], respectively; P<0.0001). Bleeding risk was significantly greater in LAAO recipients early after implantation but lower after the 6-week periprocedural period for women and men (HR, 0.772 [95% CI, 0.676-0.882]; and HR, 0.881 [95% CI, 0.784-0.989], respectively; P<0.05). CONCLUSIONS: In a real-world population of older Medicare beneficiaries with AF, compared with anticoagulation, LAAO was associated with a reduction in the risk of death, stroke, and long-term bleeding among women and men. These findings should be incorporated into shared decision-making with patients considering strategies for reduction in AF-related stroke.
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Apêndice Atrial , Fibrilação Atrial , Embolia , Acidente Vascular Cerebral , Masculino , Humanos , Feminino , Idoso , Estados Unidos/epidemiologia , Apêndice Atrial/cirurgia , Medicare , Acidente Vascular Cerebral/epidemiologia , Acidente Vascular Cerebral/etiologia , Acidente Vascular Cerebral/prevenção & controle , Hemorragia/epidemiologia , Fibrilação Atrial/complicações , Fibrilação Atrial/diagnóstico , Fibrilação Atrial/tratamento farmacológico , Embolia/epidemiologia , Anticoagulantes/efeitos adversos , Resultado do TratamentoRESUMO
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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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: 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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AIMS: To determine outcomes in atrial fibrillation patients undergoing percutaneous left atrial appendage occlusion (LAAO) based on the underlying stroke risk (defined by the CHA2DS2-VASc score). METHODS AND RESULTS: Data were extracted from the National Inpatient Sample for calendar years 2016-20. Left atrial appendage occlusion implantations were identified on the basis of the International Classification of Diseases, 10th Revision, Clinical Modification code of 02L73DK. The study sample was stratified on the basis of the CHA2DS2-VASc score into three groups (scores of 3, 4, and ≥5). The outcomes assessed in our study included complications and resource utilization. A total of 73 795 LAAO device implantations were studied. Approximately 63% of LAAO device implantations occurred in patients with CHA2DS2-VASc scores of 4 and ≥5. The crude prevalence of pericardial effusion requiring intervention was higher with increased CHA2DS2-VASc score (1.4% in patients with a score of ≥5 vs. 1.1% in patients with a score of 4 vs. 0.8% in patients with a score of 3, P < 0.01). In the multivariable model adjusted for potential confounders, CHA2DS2-VASc scores of 4 and ≥5 were found to be independently associated with overall complications [adjusted odds ratio (aOR) 1.26, 95% confidence interval (CI) 1.18-1.35, and aOR 1.88, 95% CI 1.73-2.04, respectively] and prolonged length of stay (aOR 1.18, 95% CI 1.11-1.25, and aOR 1.54, 95% CI 1.44-1.66, respectively). CONCLUSION: A higher CHA2DS2-VASc score was associated with an increased risk of peri-procedural complications and resource utilization after LAAO. These findings highlight the importance of patient selection for the LAAO procedure and need validation in future studies.
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Apêndice Atrial , Fibrilação Atrial , Acidente Vascular Cerebral , Humanos , Fibrilação Atrial/complicações , Fibrilação Atrial/diagnóstico , Fibrilação Atrial/cirurgia , Acidente Vascular Cerebral/diagnóstico , Acidente Vascular Cerebral/epidemiologia , Acidente Vascular Cerebral/etiologia , Apêndice Atrial/cirurgia , Estudos Retrospectivos , Resultado do TratamentoRESUMO
AIMS: No prior study has been adequately powered to evaluate real-world safety outcomes in those receiving adjunctive ablation lesions beyond pulmonary vein isolation (PVI). We sought to evaluate characteristics and in-hospital complications among patients undergoing PVI with and without adjunctive lesions. METHODS AND RESULTS: Patients in the National Cardiovascular Data Registry AFib Ablation Registry undergoing first-time atrial fibrillation (AF) ablation between 2016 and 2020 were identified and stratified into paroxysmal (PAF) and persistent AF, and separated into PVI only, PVI + cavotricuspid isthmus (CTI) ablation, and PVI + adjunctive (superior vena cava isolation, coronary sinus, vein of Marshall, atypical atrial flutter lines, other). Adjusted odds of adverse events were calculated using multivariable logistic regression. A total of 50 937 patients [PAF: 30 551 (60%), persistent AF: 20 386 (40%)] were included. Among those with PAF, there were no differences in the adjusted odds of complications between PVI + CTI or PVI + adjunctive when compared with PVI only. Among persistent AF, PVI + adjunctive was associated with a higher risk of any complication [3.0 vs. 4.5%, odds ratio (OR) 1.30, 95% confidence interval (CI) 1.07-1.58] and major complication (0.8 vs. 1.4%, OR 1.56, 95% CI 1.10-2.21), while no differences were observed in PVI + CTI compared with PVI only. Overall, there was high heterogeneity in adjunctive lesion type, and those receiving adjunctive lesions had a higher comorbidity burden. CONCLUSION: Additional CTI ablation was common without an increased risk of complications. Adjunctive lesions other than CTI are commonly performed in those with more comorbidities and were associated with an increased risk of complications in persistent AF, although the current analysis is limited by high heterogeneity in adjunctive lesion set type.
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BACKGROUND: Leaks from incomplete ligation of the left atrial appendage (LAA) following closure with Lariat device are not uncommon and associated with higher stroke rate. CLINICAL VIGNETTE: This clinical vignette highlights a procedure of closure of residual leak following closure with Lariat device. There was a persistent central leak of 3-4 mm with bidirectional flow, confirmed on TEE. The Amplatzer Talisman PFO Occluder was chosen for the closure of the leak because of its asymmetric discs with a smaller distal disc and expandable waist. CONCLUSION: In situations where the options are limited for PDL closure, such as the one described in this vignette, it is paramount to continue to find innovative solutions to emerging challenges in transcatheter interventions.
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Apêndice Atrial , Fibrilação Atrial , Dispositivo para Oclusão Septal , Acidente Vascular Cerebral , Humanos , Apêndice Atrial/diagnóstico por imagem , Resultado do Tratamento , Ecocardiografia Transesofagiana , Acidente Vascular Cerebral/prevenção & controle , Acidente Vascular Cerebral/complicações , Cateterismo CardíacoRESUMO
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
AIMS: To determine outcomes in atrial fibrillation (AF) patients undergoing percutaneous left atrial appendage occlusion (LAAO) with concomitant heart failure with preserved ejection fraction (HFpEF) and heart failure with reduced ejection fraction (HFrEF). METHODS AND RESULTS: Data were extracted from National Inpatient Sample for calendar years 2015-2019. LAAO device implantations were identified on the basis of ICD-10-CM code of 02L73DK. The outcomes assessed in our study included complications, in-patient mortality, and resource utilization. A total of 62 980 LAAO device implantations were studied. HFpEF (14.4%, n = 9040) and HFrEF (11.2%, n = 7100) were associated with a higher prevalence of major complications and in-patient mortality in crude analysis. In the multivariate model adjusted for potential confounders, HFpEF and HFrEF were not associated with major complications [adjusted odds ratio (aOR) 1.04, 95% confidence interval (CI) 0.93-1.16 and aOR 1.07, 95% CI 0.95-1.21] or in-patient mortality (aOR 1.48, 95% CI 0.85-2.55 and aOR 1.26, 95% CI 0.67-2.38). HFpEF and HFrEF were associated with prolonged length of stay (LOS) > 1 day (aOR 1.41, 95% CI 1.31-1.53 and aOR 1.66, 95% CI 1.53-1.80) and increased hospitalization costs > median cost 24 752$ (aOR 1.26, 95% CI 1.19-1.34 and aOR 1.21, 95% CI 1.13-1.29). CONCLUSION: The prevalence of HF in AF patients undergoing percutaneous LAAO was approximately 26%. HF was not independently associated with major complications and in-patient mortality but was associated with prolonged LOS and higher hospitalization costs.
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Apêndice Atrial , Fibrilação Atrial , Insuficiência Cardíaca , Apêndice Atrial/cirurgia , Fibrilação Atrial/diagnóstico , Fibrilação Atrial/epidemiologia , Fibrilação Atrial/cirurgia , Insuficiência Cardíaca/diagnóstico , Insuficiência Cardíaca/epidemiologia , Insuficiência Cardíaca/terapia , Hospitais , Humanos , Pacientes Internados , Prognóstico , Volume Sistólico/fisiologiaRESUMO
BACKGROUND: Limited data exists for outcomes in patients undergoing cardiovascular implantable electronic device (CIED) transvenous lead extraction (TLE) without clear indications for device reimplantation. The implantable loop recorder (ILR) may be an effective strategy for continuous monitoring in select individuals. OBJECTIVE: This retrospective analysis aims to investigate patients who have undergone ILR implant following TLE without CIED reimplantation. METHODS: Clinical data from consecutive patients who have undergone TLE with ILR implant and without CIED reimplantation from October 2016 to May 2020 at a single center were collected. RESULTS: Among 380 patients undergoing TLE, 28 (7.7%) underwent ILR placement without CIED reimplantation. TLE indications were systemic infection (n = 13, 46.4%), pain at the site (n = 8, 28.6%), device/lead malfunction (n = 4, 14.2%), and other. Devices extracted included: dual-chamber and single-chamber pacemaker (n = 14, 50%; n = 4, 14.2%), dual-chamber implantable cardiac defibrillator (n = 10; 35.7%), and cardiac-resynchronization therapy with defibrillator (n = 1, 3.5%). Reasons for no reimplantation included no longer meeting CIED criteria (n = 14, 50%), patient preference (n = 9, 32.1%), and no clear or inappropriate indication for initial CIED implantation (n = 5, 18%). During an average of 12.3 ± 13.1 months of follow-up, there were no lethal arrhythmias, and four (13.3%) patients underwent permanent pacemaker reimplantation due to symptomatic sinus bradycardia and atrioventricular block with syncope as discovered on ILR. Three patients died due to unknown causes (n = 1), noncardiac (n = 1), and acute coronary syndrome (n = 1). CONCLUSIONS: In patients undergoing TLE without reimplantation, an ILR may be an effective monitoring strategy in patients at low risk for cardiac arrhythmia.
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Desfibriladores Implantáveis , Marca-Passo Artificial , Arritmias Cardíacas/terapia , Desfibriladores Implantáveis/efeitos adversos , Eletrônica , Humanos , Marca-Passo Artificial/efeitos adversos , Estudos RetrospectivosRESUMO
OBJECTIVE: To determine trends in real-world utilization and in-hospital adverse events from Watchman implantation since its approval by the Food and Drug Administration in 2015. BACKGROUND: The risk of embolic stroke caused by atrial fibrillation is reduced by oral anticoagulants, but not all patients can tolerate long-term anticoagulation. Left atrial appendage occlusion with the Watchman device has emerged as an alternative therapy. METHODS: This was a retrospective cohort study utilizing data from National Inpatient Sample for calendar years 2015-2017. The outcomes assessed in this study were associated complications, in-hospital mortality, and resource utilization trends after Watchman implantation. Trends analysis were performed using analysis of variance. Multivariable adjusted logistic regression analysis was performed to determine predictors of mortality. RESULTS: A total of 17 700 patients underwent Watchman implantation during the study period. There was a significantly increased trend in the number of Watchman procedures performed over the study years (from 1195 in 2015 to 11 165 devices in 2017, p < .01). A significant decline in the rate of complications (from 26.4% in 2015% to 7.9% in 2017, p < .01) and inpatient mortality (from 1.3% in 2015% to 0.1% in 2017, p < .01) were noted. Predictors of in-hospital mortality included a higher CHA2 DS2 -VASc score (odds ratio [OR]: 2.61 per 1-point increase, 95% confidence interval [CI]: 1.91-3.57), chronic blood loss anemia (OR: 3.63, 95% CI: 1.37-9.61) and coagulopathy (OR: 4.90, 95% CI: 2.32-10.35). CONCLUSION: In contemporary United States clinical practice, Watchman utilization has increased significantly since approval in 2015, while complications and in-patient mortality have declined.
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Apêndice Atrial , Fibrilação Atrial , Acidente Vascular Cerebral , Anticoagulantes/efeitos adversos , Apêndice Atrial/diagnóstico por imagem , Apêndice Atrial/cirurgia , Fibrilação Atrial/diagnóstico , Fibrilação Atrial/cirurgia , Humanos , Estudos Retrospectivos , Acidente Vascular Cerebral/epidemiologia , Acidente Vascular Cerebral/etiologia , Acidente Vascular Cerebral/prevenção & controle , Resultado do Tratamento , Estados Unidos/epidemiologiaRESUMO
A 51-year-old male developed recurrent episodes of palpitations and pre-syncope after surgical aortic valve replacement. Electrocardiograms after surgery revealed a wide complex tachycardia with alternating left bundle branch and right bundle branch block morphologies. An electrophysiology study (EPS) demonstrated typical bundle branch reentry ventricular tachycardia (BBRVT) treated successfully with right bundle ablation. We demonstrate the key diagnostic features of BBRVT on EPS, describe the circuit of BBRVT with explanation of the HV pseudointerval, and highlight the association of BBRVT and valve replacement.
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BACKGROUND: Prior studies have reported an inverse association between physical activity (PA) and risk of heart failure (HF). However, a comprehensive assessment of the quantitative dose-response association between PA and HF risk has not been reported previously. METHODS AND RESULTS: Prospective cohort studies with participants >18 years of age that reported association of baseline PA levels and incident HF were included. Categorical dose-response relationships between PA and HF risk were assessed with random-effects models. Generalized least-squares regression models were used to assess the quantitative relationship between PA (metabolic equivalent [MET]-min/wk) and HF risk across studies reporting quantitative PA estimates. Twelve prospective cohort studies with 20 203 HF events among 370 460 participants (53.5% women; median follow-up, 13 years) were included. The highest levels of PA were associated with significantly reduced risk of HF (pooled hazard ratio for highest versus lowest PA, 0.70; 95% confidence interval, 0.67-0.73). Compared with participants reporting no leisure-time PA, those who engaged in guideline-recommended minimum levels of PA (500 MET-min/wk; 2008 US federal guidelines) had modest reductions in HF risk (pooled hazard ratio, 0.90; 95% confidence interval, 0.87-0.92). In contrast, a substantial risk reduction was observed among individuals who engaged in PA at twice (hazard ratio for 1000 MET-min/wk, 0.81; 95% confidence interval, 0.77-0.86) and 4 times (hazard ratio for 2000 MET-min/wk, 0.65; 95% confidence interval, 0.58-0.73) the minimum guideline-recommended levels. CONCLUSIONS: There is an inverse dose-response relationship between PA and HF risk. Doses of PA in excess of the guideline-recommended minimum PA levels may be required for more substantial reductions in HF risk.
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Insuficiência Cardíaca/epidemiologia , Insuficiência Cardíaca/prevenção & controle , Atividade Motora/fisiologia , Comportamento de Redução do Risco , Estudos de Coortes , Exercício Físico/fisiologia , Insuficiência Cardíaca/fisiopatologia , Humanos , Estudos Prospectivos , Fatores de RiscoRESUMO
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: 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
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.