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Background: Changes in tricuspid valve (TV) function following transvenous lead extraction (TLE) and their impact on long-term survival have not yet been investigated. Methods: From 3633 patients undergoing lead extraction between 2006 and 2021, TV function before and after TLE was evaluated in 2693 patients. Results: After TLE, the TV function remained unchanged in 82.36% of patients, worsened in 9.54%, and improved in 8.10%. Abandoned leads (odds ratio, OR = 1.712; p = 0.044), fibrotic adhesions between leads and TV apparatus (OR = 3.596; p < 0.001), or right ventricular wall (OR = 2.478; p < 0.001) were predisposed to TV worsening. Non-infectious indications for TLE (OR = 1.925; p < 0.001), the severity of tricuspid valve regurgitation (TVR) before TLE (OR = 3.125; p < 0.001), and lead encapsulation (OR = 2.159; p < 0.001) were predictors of improvement in TV function. Although either worsening or improving TV function had no impact on long-term survival in all patients, decreased TVR severity in the subgroup of patients with initial regurgitation grades 3-4 was associated with a better prognosis (hazard ratio, HR = 0.622; p = 0.005). Conclusions: 1. Changes in TV function after TLE were observed in 17.64% of patients. 2. Various factors can predispose to lead-related TV changes, although the common denominator in these events is an extensive buildup of scar tissue. 3. Worsening TV function had no impact on survival after TLE. In patients with severe TV dysfunction, reduction in TVR following TLE was associated with a 40% reduction in mortality during a mean follow-up of 1673 days.
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Background and Objectives: The nature of multilevel lead-related venous stenosis/occlusion (MLVSO) and its influence on transvenous lead extraction (TLE) as well as long-term survival remains poorly understood. Materials and Methods: A total of 3002 venograms obtained before a TLE were analyzed to identify the risk factors for MLVSO, as well as the procedure effectiveness and long-term survival. Results: An older patient age at the first system implantation (OR = 1.015; p < 0.001), the number of leads in the heart (OR = 1.556; p < 0.001), the placement of the coronary sinus (CS) lead (OR = 1.270; p = 0.027), leads on both sides of the chest (OR = 7.203; p < 0.001), and a previous device upgrade or downgrade with lead abandonment (OR = 2.298; p < 0.001) were the strongest predictors of MLVSO. Conclusions: The presence of MLVSO predisposes patients with cardiac implantable electronic devices (CIED) to the development of infectious complications. Patients with multiple narrowed veins are likely to undergo longer and more complex procedures with complications, and the rates of clinical and procedural success are lower in this group. Long-term survival after a TLE is similar in patients with MLVSO and those without venous obstruction. MLVSO probably better depicts the severity of global venous obstruction than the degree of vein narrowing at only one point.
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Desfibriladores Implantáveis , Marca-Passo Artificial , Doenças Vasculares , Humanos , Desfibriladores Implantáveis/efeitos adversos , Marca-Passo Artificial/efeitos adversos , Coração , Fatores de Risco , Constrição Patológica , Resultado do Tratamento , Estudos RetrospectivosRESUMO
BACKGROUND: Cardiac implantable electronic devices (CIED) are very rare in the pediatric population. In children with CIED, transvenous lead extraction (TLE) is often necessary. The course and effects of TLE in children are different than in adults. Thus, this study determined the differences and specific characteristics of TLE in children vs. adults.MethodsâandâResults: A post hoc analysis of TLE data in 63 children (age ≤18 years) and 2,659 adults (age ≥40 years) was performed. The 2 groups were compared with respect to risk factors, procedure complexity, and effectiveness. In children, the predominant pacing mode was a single chamber ventricular system and lead dysfunction was the main indication for lead extraction. The mean implant duration before TLE was longer in children (P=0.03), but the dwell time of the oldest extracted lead did not differ significantly between adults and children. The duration (P=0.006) and mean extraction time per lead (P<0.001) were longer in children, with more technical difficulties during TLE in the pediatric group (P<0.001). Major complications were more common, albeit not significantly, in children. Complete radiographic and procedural success were significantly lower in children (P<0.001). CONCLUSIONS: TLE in children is frequently more complex, time consuming, and arduous, and procedural success is more often lower. This is related to the formation of strong fibrous tissue surrounding the leads in pediatric patients.
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Desfibriladores Implantáveis , Marca-Passo Artificial , Humanos , Adulto , Criança , Adolescente , Desfibriladores Implantáveis/efeitos adversos , Marca-Passo Artificial/efeitos adversos , Remoção de Dispositivo/métodos , Fatores de Risco , Coração , Resultado do Tratamento , Estudos RetrospectivosRESUMO
The best strategy for lead management in children is a matter of debate, and our experiences are limited. This is a retrospective single-center study comparing difficulties and outcomes of transvenous lead extraction (TLE) implanted ich childhood and at age < 19 years (childhood-implanted-childhood-extracted, CICE) and at age < 19 (childhood-implanted-adulthood-extracted, CIAE). CICE patients-71 children (mean age 15.1 years) as compared to CIAE patients (114 adults (mean age 28.61 years) were more likely to have VVI than DDD pacemakers. Differences in implant duration (7.96 vs 14.08 years) appeared to be most important, but procedure complexity and outcomes also differed between the groups. Young adults with cardiac implantable electronic device implanted in childhood had more risk factors for major complications and underwent more complex procedures compared to children. Implant duration was significantly longer in CIAE patients than in children, being the most important factor that had an impact on patient safety and procedure complexity. CIAE patients were more likely to have prolonged operative duration and more complex procedures due to technical problems, and they were 2-3 times more likely to require second-line or advanced tools compared to children, but the rates of clinical and procedural success were comparable in both groups. The difference between the incidence of major complications between CICE and CIAE patients is very clear (MC 2.9 vs 7.0%, hemopericardium 1.4 vs 5.3% etc.), although statistically insignificant. Delay of lead extraction to adulthood seems to be a riskier option than planned TLE in children before growing up.
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INTRODUCTION: Cardiac tamponade (CT) is one of the most common and dangerous complications of transvenous lead extraction (TLE). So far, however, there has been little discussion about the problem. METHODS: We analyzed the occurrence of CT in a group of 1226 patients undergoing TLE at a single reference center between June, 2015 and February, 2021. Using standard mechanical devices as first-line tools, a total of 2092 leads had been extracted. RESULTS: CT occurred in 18 patients (1.47%): due to injury to the wall of the right atrium in 14 patients (1.14%) and other cardiac walls in four patients (0.33%). Younger patient age at first implantation, female gender, high left ventricular ejection fraction (LVEF), lower New York Heart Association class, low Charlson comorbidity index, longer implant duration, and the number of previous procedures related to cardiac implantable electronic devices (CIED) are important patient-related risk factors for CT. Significant procedure-related risk factors include the number of extracted leads, extraction of atrial leads and longer dwell time of extracted leads. Intraoperative transoesophageal echocardiography (TEE) provides a lot of information about pulling on various cardiac structures and is able to detect a very early phase of bleeding to the pericardial sac. As a result of implementing best practices guidance in performing extraction procedures and close collaboration with cardiac surgeons that allowed immediate rescue intervention in our series of 18 CT cases, there were no procedure-related deaths (mortality 0%). CONCLUSIONS: The need for rescue surgery due to CT has no influence on clinical and procedural success. Early diagnosed (TEE monitoring) and properly managed CT does not generate any additional risk in short- and long-term follow-up after TLE.
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Tamponamento Cardíaco , Desfibriladores Implantáveis , Marca-Passo Artificial , Humanos , Feminino , Desfibriladores Implantáveis/efeitos adversos , Remoção de Dispositivo/efeitos adversos , Remoção de Dispositivo/métodos , Falha de Equipamento , Tamponamento Cardíaco/diagnóstico por imagem , Tamponamento Cardíaco/etiologia , Tamponamento Cardíaco/terapia , Volume Sistólico , Resultado do Tratamento , Função Ventricular Esquerda , Estudos Retrospectivos , Marca-Passo Artificial/efeitos adversosRESUMO
INTRODUCTION: The professional society guidelines recommend that transvenous lead extraction (TLE) operating teams collaborate closely with cardiac surgeons in the management of life-threatening complications. METHODS: We assessed the role of cardiac surgeons participating in 3462 TLE procedures at a high-volume center between 2006 and 2021. The roles for cardiac surgery in TLE can be categorized into five areas: emergency surgical interventions for the management of cardiac laceration and severe bleeding (1.184%), cardiac surgery complementing partially successful TLE or vegetation removal (0.693%), delayed surgical treatment of TLE-related tricuspid valve dysfunction (0.751%), epicardial pacemaker implantation through sternotomy during emergency, complementing or delayed surgical interventions (0.607%), and delayed epicardial lead implantation (0.491%). RESULTS: Isolated damage to the wall of the right atrium was the most common cause of cardiac tamponade (53.66% of emergency surgeries) followed by injury to the right ventricle and vena cava (both 7.317%). CONCLUSIONS: Emergency cardiac surgery for the management of severe hemorrhagic complications is still the most common treatment option. The remaining areas include surgery complementing partially successful TLE: repair of tricuspid valve or epicardial ventricular lead placement to achieve permanent cardiac resynchronization. The experience at a single high-volume TLE center indicates the necessity of close collaboration with the cardiac surgeons whose roles appear broader than the mere surgical standby. Mortality in patients who survived cardiac surgery during TLE does not differ from the survival of other patients after TLE without complications requiring surgical intervention.
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Desfibriladores Implantáveis , Marca-Passo Artificial , Cirurgiões , Remoção de Dispositivo/efeitos adversos , Remoção de Dispositivo/métodos , Humanos , Estudos Retrospectivos , Resultado do TratamentoRESUMO
AIMS: Transvenous lead extraction is associated with a significant risk of complications and identifying patients at highest risk pre-procedurally will enable interventions to be planned accordingly. We developed the ELECTRa Registry Outcome Score (EROS) and applied it to the ELECTRa registry to determine if it could appropriately risk-stratify patients. METHODS AND RESULTS: EROS was devised to risk-stratify patients into low risk (EROS 1), intermediate risk (EROS 2), and high risk (EROS 3). This was applied to the ESC EORP European Lead Extraction ConTRolled ELECTRa registry; 57.5% EROS 1, 31.8% EROS 2, and 10.7% EROS 3. Patients with EROS 3 or 2 were significantly more likely to require powered sheaths and a femoral approach to complete procedures. Patients with EROS 3 were more likely to suffer procedure-related major complications including deaths (5.1 vs. 1.3%; P < 0.0001), both intra-procedural (3.5 vs. 0.8%; P = 0.0001) and post-procedural (1.6 vs. 0.5%; P = 0.0192). They were more likely to suffer post-procedural deaths (0.8 vs. 0.2%; P 0.0449), cardiac avulsion or tear (3.8 vs. 0.5%; P < 0.0001), and cardiovascular lesions requiring pericardiocentesis, chest tube, or surgical repair (4.6 vs. 1.0%; P < 0.0001). EROS 3 was associated with procedure-related major complications including deaths [odds ratio (OR) 3.333, 95% confidence interval (CI) 1.879-5.914; P < 0.0001] and all-cause in-hospital major complications including deaths (OR 2.339, 95% CI 1.439-3.803; P = 0.0006). CONCLUSION: EROS successfully identified patients who were at increased risk of significant procedural complications that require urgent surgical intervention.
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Desfibriladores Implantáveis , Marca-Passo Artificial , Desfibriladores Implantáveis/efeitos adversos , Remoção de Dispositivo , Humanos , Sistema de Registros , Medição de Risco , Resultado do TratamentoRESUMO
INTRODUCTION: Transvenous lead extraction (TLE) has become a frequently used tool for the management of complications related to pacemakers, implantable cardiac defibrillators and cardiac resynchronization therapy devices. However, it is still a matter of debate whether the lead extraction procedure is a safe treatment choice in the elderly. METHODS: We collected the clinical information from 3,810 patients undergoing TLE in 2 high-volume centers (Poland and Italy) between 2006 and 2017. We tested risk factors, effectiveness, safety and long-term survival in 3 groups of patients: those aged 80-89.99 years, ≥90 years and 30-79.99 years. RESULTS: Lower BMI, lower levels of hemoglobin and more comorbidities characterized the patients, whose ages ranged from 80 to 89.99 years. Those aged ≥90 years most often had single-chamber pacemakers. Octogenarians and nonagenarians were more often undergoing TLE due to infectious indications (57.19 and 74.29 vs. 45.35% in younger individuals). Lead age and the number of leads extracted were comparable in the 3 groups. In octogenarians, leads were more often removed using standard extraction techniques: simple traction and mechanical dilatators, whereas in nonagenarians TLE was more complex. The duration of the procedure was shorter in older patients, while clinical and procedural effectiveness was similar to that in younger individuals. The rate of major complications related to TLE did not differ between octogenarians and younger subjects (2.0 vs. 1.38%, p = ns), and the number of procedure-related risk factors was smaller in older people. Nonagenarians did not develop any major complication related to TLE. Long-term mortality after TLE was similar among octogenarians and nonagenarians (39.67 and 40.00%) but higher than in younger patients (24.41; p < 0.001 and 0.05). CONCLUSIONS: Lead extraction procedures appear effective and safe in octogenarians and nonagenarians, comparable to younger individuals. Procedure-related risk in the elderly is not associated with most of the typical risk factors encountered in younger subjects, but only with the higher number of pacemaker, implantable cardiac defibrillator and cardiac resynchronization therapy device procedures before TLE. Long-term survival after TLE was found to be similar among octogenarians and nonagenarians being about 60% at over 3 years of follow-up. Age alone should not be considered a risk factor for the occurrence of major complications or procedure-related death, and therefore it should not prevent candidacy for TLE.
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Dispositivos de Terapia de Ressincronização Cardíaca/efeitos adversos , Desfibriladores Implantáveis/efeitos adversos , Remoção de Dispositivo/métodos , Marca-Passo Artificial/efeitos adversos , Complicações Pós-Operatórias , Procedimentos Cirúrgicos Vasculares , Fatores Etários , Idoso de 80 Anos ou mais , Feminino , Humanos , Itália/epidemiologia , Masculino , Pessoa de Meia-Idade , Polônia/epidemiologia , Complicações Pós-Operatórias/diagnóstico , Complicações Pós-Operatórias/epidemiologia , Medição de Risco/métodos , Medição de Risco/estatística & dados numéricos , Fatores de Risco , Análise de Sobrevida , Tempo , Resultado do Tratamento , Procedimentos Cirúrgicos Vasculares/efeitos adversos , Procedimentos Cirúrgicos Vasculares/instrumentação , Procedimentos Cirúrgicos Vasculares/métodosRESUMO
We present a case study article demonstrating successful implementation of ultrasound guided extra cardiac vagus nerve stimulation during cardioneuroablation. To our knowledge it is first published description of this technique, as most ECVS are done in the internal jugular vein bulb area. This method allows for reduction of fluoroscopy time, and most importantly reproducible vagus nerve capture especially after full bi-nodal (sinus and atrioventricular) cardioneuroablation when stimulation of vagus nerve may not give any effect in the heart. This article includes a case study with "dual component" atrioventricular block, where functional component is cured with cardioneuroablation, but structural (PR elongation) remains after procedure.
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AIMS: Transvenous lead extraction (TLE) should ideally be undertaken by experienced operators in a setting that allows urgent surgical intervention. In this analysis of the ELECTRa registry, we sought to determine whether there was a significant difference in procedure complications and mortality depending on centre volume and extraction location. METHODS AND RESULTS: Analysis of the ESC EORP European Lead Extraction ConTRolled ELECTRa registry was conducted. Low-volume (LoV) centres were defined as <30 procedures/year, and high-volume (HiV) centres as ≥30 procedures/year. Three thousand, two hundred, and forty-nine patients underwent TLE by a primary operator cardiologist; 17.1% in LoV centres and 82.9% in HiV centres. Procedures performed by primary operator cardiologists in LoV centres were less likely to be successful (93.5% vs. 97.1%; P < 0.0001) and more likely to be complicated by procedure-related deaths (1.1% vs. 0.4%; P = 0.0417). Transvenous lead extraction undertaken by primary operator cardiologists in LoV centres were associated with increased procedure-related major complications including death (odds ratio 1.858, 95% confidence interval 1.007-3.427; P = 0.0475). Transvenous lead extraction locations varied; 52.0% operating room, 9.5% hybrid theatre and 38.5% catheterization laboratory. Rates of procedure-related major complications, including death occurring in a high-risk environment (combining operating room and hybrid theatre), were similar to those undertaken in the catheterization laboratory (1.7% vs. 1.6%; P = 0.9297). CONCLUSION: Primary operator cardiologists in LoV centres are more likely to have extractions complicated by procedure-related deaths. There was no significant difference in procedure complications between different extraction settings. These findings support the need for TLE to be performed in experienced centres with appropriate personnel present.
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Desfibriladores Implantáveis , Remoção de Dispositivo , Marca-Passo Artificial , Desfibriladores Implantáveis/efeitos adversos , Remoção de Dispositivo/efeitos adversos , Remoção de Dispositivo/mortalidade , Humanos , Marca-Passo Artificial/efeitos adversos , Sistema de Registros , Fatores de TempoRESUMO
AIMS: The usefulness of transesophageal echocardiographic (TEE) monitoring for transvenous lead extraction (TLE) procedures is still controversial. The purpose of the current study was to present new TEE values in detecting invisible events in fluoroscopy and preventing the development of dangerous complications. METHODS: From 2015 to 2019, a total of 1026 procedures were performed in single TLE center. In total, 1108 leads had been extracted with a mean lead dwell time of 115.8 ± 77.6 months. Continuous TEE was used in 936 patients with a mean age of 67.1 ± 14.4 years. RESULTS: Preprocedure examination revealed looped leads in 181 (19.3%) patients, dry cardiac perforation in 151 (16.1%), lead-to-lead adhesion in 172 (18.4%), lead adhesion to the myocardium in 317 (33.9%), and vegetations in 119 (12.7%) patients. Intra-procedural TEE demonstrated pulling on the atrial wall, ventricular wall, or tricuspid valve in 380 (40.5%), 235 (25.1%), and 78 (8.3%) patients, respectively. Acute tamponade requiring sternotomy occurred in 11 (1.1%) patients. Migration of vegetation or connective tissue fragments were seen in 69 (7.3%) and 111 (11.8%) patients, respectively. After procedure, TEE was helpful in navigating an implantation, a new lead in 97 (10.3%) patients, and removing the remnants of lead/silicone insulation in 50 (5.3%) patients. CONCLUSION: Real time transesophageal echocardiography for the guidance of transvenous lead extraction informs the operator about the danger of manipulations close to delicate cardiac structures and whether immediate modification to the plan of lead removal is necessary in order to prevent the occurrence of unwanted events.
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Desfibriladores Implantáveis , Ecocardiografia Transesofagiana , Idoso , Idoso de 80 Anos ou mais , Remoção de Dispositivo , Humanos , Pessoa de Meia-Idade , Estudos Retrospectivos , Valva TricúspideAssuntos
Remoção de Dispositivo , Valva Tricúspide , Humanos , Desfibriladores Implantáveis , Remoção de Dispositivo/efeitos adversos , Traumatismos Cardíacos/etiologia , Traumatismos Cardíacos/diagnóstico por imagem , Traumatismos Cardíacos/cirurgia , Marca-Passo Artificial/efeitos adversos , Recuperação de Função Fisiológica , Resultado do Tratamento , Valva Tricúspide/cirurgia , Valva Tricúspide/fisiopatologia , Valva Tricúspide/diagnóstico por imagem , Insuficiência da Valva Tricúspide/cirurgia , Insuficiência da Valva Tricúspide/etiologia , Insuficiência da Valva Tricúspide/diagnóstico por imagem , Insuficiência da Valva Tricúspide/fisiopatologiaRESUMO
INTRODUCTION: Little data are available on anticoagulation (AC) management in patients with cardiac resynchronization (CRT) devices who undergo transvenous lead extraction (TLE) procedure. We investigated the impact of AC on periprocedural complications in CRT patients undergoing TLE, enrolled in the ESC-EHRA European Lead Extraction ConTrolled (ELECTRa) registry. METHODS AND RESULTS: All CRT patients treated with TLE enrolled in the registry were considered. Perioperative AC management was left to the discretion of the Center. Major and minor intraprocedural and postprocedural complications were compared between patients without AC (Gp1) and patients with AC (Gp2). Regression analyses were performed to identify predictors of complications for Gp2. Out of 734 CRT pts, 328 (44.7%) were under AC (Gp2). Patients from Gp2 presented lower LVEF (Gp2 32.5 ± 10.9 vs Gp1 34.5 ± 11.9%; P = 0.03), more advanced heart failure disease (NYHA III/IV: Gp2 42.0 vs Gp1 31.5%; P = 0.02), and renal impairment (Gp2 39.0 vs Gp1 24.3%; P < 0.001). Perioperative regimens included AC interruption (Gp2A: n = 169, 51.5%), "bridging" (Gp2B: n = 135, 41.2%), or continued AC (Gp2C: n = 24, 7.3%). TLE complete success rates (98% in both groups) and major complication rates were comparable for both groups; minor bleeding events were more frequent in Gp2 (5.5%) compared to Gp1 (2.5%; P = 0.051). No independent predictors were identified for Gp2, but minor complications were associated with "bridging" approach (Gp2B: 16 events vs Gp2A/C: 9 events; P = 0.020). CONCLUSION: CRT patients treated with TLE under AC were more compromised but did not present more major complications compared to patients without AC. More minor complications were associated with "bridging" AC regimen.
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Anticoagulantes/administração & dosagem , Dispositivos de Terapia de Ressincronização Cardíaca , Terapia de Ressincronização Cardíaca , Remoção de Dispositivo , Insuficiência Cardíaca/terapia , Idoso , Anticoagulantes/efeitos adversos , Terapia de Ressincronização Cardíaca/efeitos adversos , Remoção de Dispositivo/efeitos adversos , Europa (Continente) , Feminino , Nível de Saúde , Insuficiência Cardíaca/diagnóstico , Insuficiência Cardíaca/fisiopatologia , Hemorragia/induzido quimicamente , Humanos , Masculino , Pessoa de Meia-Idade , Sistema de Registros , Estudos Retrospectivos , Fatores de Risco , Volume Sistólico , Fatores de Tempo , Resultado do Tratamento , Função Ventricular EsquerdaRESUMO
AIMS: A sub-analysis of the ESC-EHRA European Lead Extraction ConTRolled (ELECTRa) Registry to evaluate the clinical impact of antithrombotic (AT) on transvenous lead extraction (TLE) safety and efficacy. METHODS AND RESULTS: ELECTRa outcomes were compared between patients without AT therapy (No AT Group) and with different pre-operative AT regimens, including antiplatelets (AP), anticoagulants (AC), or both (AP + AC). Out of 3510 pts, 2398 (68%) were under AT pre-operatively. AT patients were older with more comorbidities (P < 0.0001). AT subgroups, defined as AP, AC, or AP + AC, were 1096 (31.2%), 985 (28%), and 317 (9%), respectively. Regarding AP patients, 1413 (40%) were under AP, 1292 (91%) with a single AP, interrupted in 26% about 3.8 ± 3.7 days before TLE. In total, 1302 (37%) patients were under AC, 881 vitamin K antagonist (68%), 221 (17%) direct oral anticoagulants, 155 (12%) low weight molecular heparin, and 45 (3.5%) unfractionated heparin. AC was 'interrupted without bridging' in 696 (54%) and 'interrupted with bridging' in 504 (39%) about 3.3 ± 2.3 days before TLE, and 'continued' in 87 (7%). TLE success rate was high in all subgroups. Only overall in-hospital death (1.4%), but not the procedure-related one, was higher in the AT subgroups (P = 0.0500). Age >65 years and New York Heart Association Class III/IV, but not AT regimens, were independent predictors of death for any cause. Haematomas were more frequent in AT subgroups, especially in AC 'continued' (P = 0.025), whereas pulmonary embolism in the No-AT (P < 0.01). CONCLUSIONS: AT minimization is safe in patients undergoing TLE. AT does not seem to predict death but identifies a subset of fragile patients with a worse in-hospital TLE outcome.
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Remoção de Dispositivo/efeitos adversos , Eletrodos Implantados , Fibrinolíticos/administração & dosagem , Marca-Passo Artificial , Complicações Pós-Operatórias/epidemiologia , Fatores Etários , Idoso , Comorbidade , Falha de Equipamento , Europa (Continente)/epidemiologia , Feminino , Mortalidade Hospitalar , Humanos , Masculino , Pessoa de Meia-Idade , Sistema de Registros , Fatores de RiscoRESUMO
AIMS: We aimed at describing outcomes and predictors of cardiac avulsion or tear (CA/T) with tamponade and vascular avulsion or tear (VA/T) after transvenous lead extraction (TLE) in the ESC-EHRA European Lead Extraction ConTRolled (ELECTRa) registry. METHODS AND RESULTS: A total of 3555 consecutive patients of whom 3510 underwent TLE at 73 centres in 19 European countries were enrolled. Among 58 patients (1.7%) with procedure-related major complications, 49 (84.5%) patients (30 CA/T and 19 VA/T) presented cardiovascular complications requiring pericardiocentesis, chest tube positioning and/or surgical repair. The mortality was 20% in patients with tamponade due to CA/T and 31.6% in patients with VA/T. Pericardiocentesis as first manoeuvre followed by rescue surgical repair was highly effective in case of CA/T (93.8%). At multivariate analysis, CA/T with tamponade was more common in RIATA lead extraction, female patients, leads with a mean dwelling time more than 10 years, and when ≥3 leads were extracted or multiple sheaths required. Occlusion or critical stenosis of superior venous access and the leads mean dwelling time more than 10 years were independent predictors for VA/T, while mechanical dilatation was an independent predictor of a lower incidence of this complication as compared to the use of powered sheaths. CONCLUSIONS: In the ELECTRa registry, RIATA lead extraction and superior venous access occlusion/thrombosis are two new independent predictors for cardiac tamponade and major vascular complications, respectively. The use of mechanical sheaths seems to be associated with a lower incidence of VA/T. A strategy of pericardiocentesis followed by a rescue surgical approach seems to be reasonable in order to treat a CA/T with tamponade.
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Tamponamento Cardíaco , Desfibriladores Implantáveis/efeitos adversos , Remoção de Dispositivo , Marca-Passo Artificial/efeitos adversos , Pericardiocentese , Complicações Pós-Operatórias , Tamponamento Cardíaco/diagnóstico , Tamponamento Cardíaco/mortalidade , Tamponamento Cardíaco/cirurgia , Remoção de Dispositivo/efeitos adversos , Remoção de Dispositivo/instrumentação , Remoção de Dispositivo/métodos , Falha de Equipamento , Europa (Continente)/epidemiologia , Feminino , Humanos , Incidência , Masculino , Pessoa de Meia-Idade , Avaliação de Processos e Resultados em Cuidados de Saúde , Pericardiocentese/métodos , Pericardiocentese/estatística & dados numéricos , Complicações Pós-Operatórias/diagnóstico , Complicações Pós-Operatórias/epidemiologia , Complicações Pós-Operatórias/cirurgia , Prognóstico , Sistema de Registros/estatística & dados numéricos , Fatores de Risco , Trombose/diagnóstico , Trombose/epidemiologia , Lesões do Sistema Vascular/diagnóstico , Lesões do Sistema Vascular/epidemiologiaRESUMO
AIMS: The decision to abandon or extract superfluous leads remains controversial. We sought to compare procedural outcome of patients with and without abandoned leads undergoing transvenous lead extraction (TLE). METHODS AND RESULTS: An analysis of the ESC-EHRA European Lead Extraction ConTRolled ELECTRa registry was conducted. Patients were stratified into two groups based on the presence (Group 1) or absence (Group 2) of abandoned leads at the time for extraction. Out of 3508 TLE procedures, 422 patients (12.0%) had abandoned leads (Group 1). Group 1 patients were older and more likely to have implantable cardioverter-defibrillator devices, infection indication (78.8% vs. 49.8%), and vegetations (24.6% vs. 15.3%). Oldest lead dwelling time was longer in Group 1 (10.9 vs. 6.3 years) as was the number of extracted leads per patient (3.2 vs. 1.7). Manual traction failure (94.5% vs. 78.8%), powered sheath use (50.7% vs. 28.4%), and femoral approach were higher in Group 1 (P < 0.0001). Procedural success rate and clinical success (89.8% vs. 96.6%, P < 0.0001) were lower in Group 1. Major complication including deaths (5.5% vs. 2.3%, P = 0.0007) and procedure related major complications (3.3% vs. 1.4%, P = 0.0123) were higher in Group 1. The presence of abandoned leads at the time of TLE was an independent predictor of clinical failure [odds ratio (OR) 2.31, confidence interval (CI) 1.57-3.40] and complications [OR 1.69, CI 1.22-2.35]. receiver-operating characteristic curve analysis showed a dwell time threshold of 9 years for radiological failure and major complications. CONCLUSIONS: Previously abandoned leads at the time of TLE were associated with increased procedural complexity, clinical failure, and major complication, which may have important implications for future studies regarding managing of lead failures.
Assuntos
Remoção de Dispositivo/métodos , Falha de Equipamento , Marca-Passo Artificial , Complicações Pós-Operatórias/epidemiologia , Infecções Relacionadas à Prótese/cirurgia , Idoso , Cateterismo Cardíaco/métodos , Dispositivos de Terapia de Ressincronização Cardíaca/efeitos adversos , Desfibriladores Implantáveis , Feminino , Humanos , Imageamento por Ressonância Magnética , Masculino , Recall de Dispositivo Médico , Pessoa de Meia-Idade , Marca-Passo Artificial/efeitos adversos , Curva ROC , Sistema de Registros , Fatores de Tempo , Trombose Venosa/etiologia , Trombose Venosa/cirurgiaRESUMO
AIMS: The present study sought to determine predictors for success and outcomes of patients who underwent cardiac implantable electronic devices (CIED) extraction indicated for systemic or local CIED related infection in particular where complete lead removal could not be achieved. METHODS AND RESULTS: ESC-EORP ELECTRa (European Lead Extraction ConTRolled Registry) is a European prospective lead extraction registry. Out of the total cohort, 1865/3510 (52.5%) patients underwent removal due to CIED related infection. Predictors and outcomes of failure were analysed. Complete removal was achieved in 1743 (93.5%) patients, partial (<4 cm of lead left) in 88 (4.7%), and failed (>4 cm of lead left) in 32 (1.8%) patients. Removal success was unrelated to type of CIED infection (pocket or systemic). Predictors for failure were older leads and older patients [odds ratio (OR) 1.14 (1.08-1.19), P < 0.0001 and OR 2.68 (1.22-5.91), P = 0.0146, respectively]. In analysis by lead, predictors for failure were: pacemaker vs. defibrillator removal and failure to engage the locking stylet all the way to the tip [OR 0.20 (0.04-0.95), P = 0.03 and OR 0.32 (0.13-0.74), P = 0.008, respectively]. Significantly higher complication rates were noted in the failure group (40.6% vs. 15.9 for partial and 8.7% for success groups, P < 0.0001). Failure to remove a lead was a strong predictor for in hospital mortality [hazard ratio of 2.05 (1.01-4.16), P = 0.046]. CONCLUSION: A total of 6.5% of infected CIED patients failed attempted extraction. Only were >4 cm of lead remained resulted in higher procedural complications and mortality rates.
Assuntos
Dispositivos de Terapia de Ressincronização Cardíaca , Desfibriladores Implantáveis , Remoção de Dispositivo/estatística & dados numéricos , Marca-Passo Artificial , Infecções Relacionadas à Prótese/terapia , Fatores Etários , Idoso , Antibacterianos/uso terapêutico , Eletrodos Implantados , Europa (Continente) , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Sistema de Registros , Fatores de Tempo , Falha de Tratamento , Resultado do TratamentoRESUMO
AIMS: Female sex is considered an independent risk factor of transvenous leads extraction (TLE) procedure. The aim of the study was to evaluate the effectiveness of TLE in women compared with men. METHODS AND RESULTS: A post hoc analysis of risk factors and effectiveness of TLE in women and men included in the ESC-EHRA EORP ELECTRa registry was conducted. The rate of major complications was 1.96% in women vs. 0.71% in men; P = 0.0025. The number of leads was higher in men (mean 1.89 vs. 1.71; P < 0.0001) with higher number of abandoned leads in women (46.04% vs. 34.82%; P < 0.0001). Risk factors of TLE differed between the sexes, of which the major were: signs and symptoms of venous occlusion [odds ratio (OR) 3.730, confidence interval (CI) 1.401-9.934; P = 0.0084], cumulative leads dwell time (OR 1.044, CI 1.024-1.065; P < 0.001), number of generator replacements (OR 1.029, CI 1.005-1.054; P = 0.0184) in females and the number of leads (OR 6.053, CI 2.422-15.129; P = 0.0001), use of powered sheaths (OR 2.742, CI 1.404-5.355; P = 0.0031), and white blood cell count (OR 1.138, CI 1.069-1.212; P < 0.001) in males. Individual radiological and clinical success of TLE was 96.29% and 98.14% in women compared with 98.03% and 99.21% in men (P = 0.0046 and 0.0098). CONCLUSION: The efficacy of TLE was lower in females than males, with a higher rate of periprocedural major complications. The reasons for this difference are probably related to disparities in risk factors in women, including more pronounced leads adherence to the walls of the veins and myocardium. Lead management may be key to the effectiveness of TLE in females.
Assuntos
Dispositivos de Terapia de Ressincronização Cardíaca , Desfibriladores Implantáveis , Remoção de Dispositivo , Complicações Intraoperatórias/epidemiologia , Complicações Pós-Operatórias/epidemiologia , Infecções Relacionadas à Prótese/terapia , Idoso , Idoso de 80 Anos ou mais , Fontes de Energia Elétrica , Europa (Continente) , Feminino , Humanos , Contagem de Leucócitos , Masculino , Pessoa de Meia-Idade , Razão de Chances , Marca-Passo Artificial , Sistema de Registros , Fatores Sexuais , Fatores de Tempo , Insuficiência da Valva Tricúspide/epidemiologia , Trombose Venosa/epidemiologiaRESUMO
INTRODUCTION: The increasing number of cardiac implantable electronic device complications represents a current problem. Abandoned leads are difficult to manage, even because indications to transvenous lead extraction (TLE) cannot be generalized. The aim of the study was to assess the late consequences of previous abandoned leads. METHODS: We did a retrospective analysis of clinical data from 3,810 patients undergoing TLE in two high-volume centers (Poland and Italy) in the years 2006-2017. In order to evaluate the effects of lead abandonment, the patients were divided into a group of 582 (15.3%) subjects with abandoned leads (AL) and a group of 3,228 (84.7%) subjects with functional leads (FL). RESULTS: Infective indications to TLE were predominant in the AL group (61.34% vs 43.4%; P < 0.001). AL was associated with a higher number of leads per patient, longer lead dwell times, more frequent venous occlusion, higher probability of intracardiac lead abrasion, and tricuspid regurgitation (P < 0.001 for all factors). The presence of AL was connected with more frequent technical complications of TLE (odds ratio [OR] 1.617; confidence interval [CI] 1.412-1.852; P = 0.000), lower procedural success rate (OR 0.270; CI 0.199-0.363; P = 0.000), and with higher mortality rate during 3.518 years of follow-up [hazard ratio 1.286; 95% CI (1.062-1.558), P = 0.010]. CONCLUSIONS: Presence of previously abandoned leads was associated with the risk of device infections, technical problems during subsequent lead extraction, dysfunction of tricuspid valve, and worse long-term outcomes.