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INTRODUCTION: Transvenous lead extraction (TLE), while mostly a safe procedure, has risk of serious periprocedural complications. As such, overnight hospitalization remains a routine practice. In our center, we routinely discharge patients on the same day following an uncomplicated TLE. METHODS: This is a retrospective study of 265 consecutive patients who underwent uncomplicated TLE in our center between 2019 and 2021. Same-day discharge (SDD) patients are compared with those who stayed at least overnight for observation after the TLE procedure (non-SDD group). To assess the safety of an SDD strategy after uncomplicated TLE, the main study endpoint was to compare the rate of major procedure-related complications at 1-, 7-, and 30-days. To identify the factors influencing the operator's decision to discharge the patient on the same day, the secondary endpoint was to analyze clinical and procedural predictors of SDD. RESULTS: A total of 153 patients were discharged the same day after uncomplicated TLE (SDD), while 112 stayed at least overnight after the procedure (non-SDD). There was no significant difference in major procedure-related complications at 1-day (SDD 0% vs. non-SDD 1.8%, p value = ns), while patients in the SDD group had a lower rate of 7- and 30-day complications when compared with those in the non-SDD group (2.1% vs. 8.2%, p value = .0308; and 3.5% vs. 16%, p value = .0049, respectively). Noninfectious indication for TLE (OR 16.1, 95% confidence interval [CI] 4.29-77.6) and procedure end time before 12:00 (OR 2.82, 95% CI 1.11-7.27) were the only independent predictors of SDD. CONCLUSION: SDD discharge following uncomplicated TLE in selected patients (i.e., those without device infection and when the TLE procedure is completed in the morning) is feasible and safe.
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Hospitalização , Alta do Paciente , Humanos , Remoção de Dispositivo , Estudos de Viabilidade , Estudos Retrospectivos , Resultado do TratamentoRESUMO
INTRODUCTION: Transvenous lead extraction (TLE) is generally considered a safe procedure, albeit not without risks. While gender-based disparities have been noted in short-term outcomes following TLE, a notable gap exists in understanding the long-term consequences of this procedure. The objective of this analysis was to investigate sex differences in both acute and long-term outcomes among patients who underwent TLE at a tertiary referral center. METHODS: In this retrospective cohort study, consecutive patients who underwent TLE between January 2014 and January 2016 were enrolled. The primary outcome comprised a composite of all-cause mortality and need for repeated TLE procedures. Secondary outcomes included fluoroscopy time, lead extraction techniques, success rates, and major and minor complications. Results were compared between female and male cohorts. RESULTS: The study population comprised 191 patients (median age, 70 years), 29 (15.2%) being women and 162 men (84.8%). Study groups had similar baseline characteristics. Complete procedural success was achieved in 189 out of 191 patients (99.0%), with no significant difference observed between the two groups (p = .17). No major complications were reported in the total cohort. However, there was a significantly higher incidence of minor complications in women compared to men (17.2% vs. 2.5%, p < .01). Following a median follow-up of 6.5 years, the incidence of the primary composite outcome occurred similarly between the study groups (log-rank p = .68). CONCLUSION: Women who underwent TLE exhibited a significantly higher incidence of minor acute intra- and peri-procedural complications than men. However, no differences in long-term outcomes between genders were observed.
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INTRODUCTION: Transvenous lead extractions (TLEs) for cardiac implantable electronic device complications often encounter difficulties with strong adhesions to the myocardium or vessels. In this report, we introduce a novel "Four-Stage Rocket" technique for effective TLE in cases where conventional methods fail. METHODS AND RESULTS: Two challenging cases where conventional TLE methods failed were treated using a combination of four devices: Needle's Eye Snare, Agilis NxT Steerable Introducer, GlideLight Laser sheath, and GORE® DrySeal Flex Introducer sheath, employed via the inferior vena cava. The "Four-Stage Rocket" technique successfully detached firmly adhered leads near the tricuspid valve annulus, where the traditional superior vena cava approach was inadequate. CONCLUSION: The "Four-Stage Rocket" technique offers a potential alternative in complex TLE cases, aligning the laser direction with the adhesion detachment and reducing the tissue damage risk.
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Desfibriladores Implantáveis , Remoção de Dispositivo , Veia Femoral , Lasers , Marca-Passo Artificial , Humanos , Remoção de Dispositivo/instrumentação , Remoção de Dispositivo/métodos , Masculino , Idoso , Resultado do Tratamento , Feminino , Pessoa de Meia-Idade , Cateterismo Periférico/instrumentaçãoRESUMO
INTRODUCTION: Reports of comparison with procedural outcomes for implantable cardioverter defibrillator (ICD) and pacemaker (PM) transvenous lead extraction (TLE) are old and limited. We sought to compare the safety, efficacy, and procedural properties of ICD and PM TLE and assess the impact of lead age. METHODS: The study cohort included all consecutive patients with ICD and PM TLE in the Cleveland Clinic Prospective TLE Registry between 2013 and 2022. Extraction success, complications, and failure employed the definitions described in the HRS 2017 TLE guidelines. RESULTS: A total of 885 ICD leads, a median implant duration of 8 (5-11) years in 810 patients, and 1352 PM leads of 7 (3-13) years in 807 patients were included. Procedural success rates in ICD patients were superior to those of PM in >20 years leads but similar in ≤20 years leads. In the PM group, the complete success rate of TLE decreased significantly according to the increase of lead age, but not in the ICD group. ICD TLE required more extraction tools compared with PM TLE but cases with older leads required non-laser sheath extraction tools in both groups. The most common injury site in major complication cases differed between ICD and PM TLE, although major complication rates showed no difference in both groups (2.7% vs. 1.6%, p = .12). CONCLUSION: The procedural success rate by TLE is greater for ICD patients than PM patients with leads >20 years old but requires more extraction tools. Common vascular complication sites and the impact of lead age on procedural outcomes and required tools differed between ICD and PM TLE.
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Desfibriladores Implantáveis , Remoção de Dispositivo , Marca-Passo Artificial , Sistema de Registros , Humanos , Masculino , Feminino , Idoso , Pessoa de Meia-Idade , Remoção de Dispositivo/efeitos adversos , Resultado do Tratamento , Fatores de Tempo , Fatores de Risco , Ohio , Cardioversão Elétrica/instrumentação , Cardioversão Elétrica/efeitos adversos , Hospitais com Alto Volume de Atendimentos , Idoso de 80 Anos ou mais , Medição de RiscoRESUMO
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: Given the challenges of conventional therapies in managing right-sided infective endocarditis (RSIE), percutaneous mechanical aspiration (PMA) of vegetations has emerged as a novel treatment option. Data on trends, characteristics, and outcomes of PMA, however, have largely been limited to case reports and case series. AIMS: The aim of the current investigation was to provide a descriptive analysis of PMA in the United States and to profile the frequency of PMA with a temporal analysis and the patient cohort. METHODS: The International Classification of Diseases, 10th Revision codes were used to identify patients with RSIE in the national (nationwide) inpatient sample (NIS) database between 2016 and 2020. The clinical characteristics and temporal trends of RSIE hospitalizations in patients who underwent PMA was profiled. RESULTS: An estimated 117,955 RSIE-related hospital admissions in the United States over the 5-year study period were estimated and 1675 of them included PMA. Remarkably, the rate of PMA for RSIE increased 4.7-fold from 2016 (0.56%) to 2020 (2.62%). Patients identified with RSIE who had undergone PMA were young (medial age 36.5 years) and had few comorbid conditions (median Charlson Comorbidity Index, 0.6). Of note, 36.1% of patients had a history of hepatitis C infection, while only 9.9% of patients had a cardiovascular implantable electronic device. Staphylococcus aureus was the predominant (61.8%) pathogen. Concomitant transvenous lead extraction and cardiac valve surgery during the PMA hospitalization were performed in 18.2% and 8.4% of admissions, respectively. The median hospital stay was 19.0 days, with 6.0% in-hospital mortality. CONCLUSIONS: The marked increase in the number of PMA procedures in the United States suggests that this novel treatment option has been embraced as a useful tool in select cases of RSIE. More work is needed to better define indications for the procedure and its efficacy and safety.
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Endocardite Bacteriana , Endocardite , Humanos , Estados Unidos/epidemiologia , Adulto , Pacientes Internados , Sucção , Resultado do Tratamento , Estudos Retrospectivos , Endocardite/diagnóstico , Endocardite/terapia , Endocardite Bacteriana/diagnóstico , Endocardite Bacteriana/terapiaRESUMO
AIMS: Debulking of infective mass to reduce the burden if infective material is a fundamental principle in the surgical management of infection. The aim of this study was to investigate the validity of this principle in patients undergoing transvenous lead extraction in the context of bloodstream infection (BSI). METHODS AND RESULTS: We performed an observational single-centre study on patients that underwent transvenous lead extraction due to a BSI, with or without lead-associated vegetations, in combination with a percutaneous aspiration system during the study period 2015-22. One hundred thirty-seven patients were included in the final analysis. In patients with an active BSI at the time of intervention, the use of a percutaneous aspiration system had a significant impact on survival (log-rank: P = 0.0082), while for patients with a suppressed BSI at the time of intervention, the use of a percutaneous aspiration system had no significant impact on survival (log-rank: P = 0.25). CONCLUSION: A reduction of the infective burden by percutaneous debulking of lead vegetations might improve survival in patients with an active BSI.
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Remoção de Dispositivo , Infecções Relacionadas à Prótese , Humanos , Feminino , Masculino , Remoção de Dispositivo/métodos , Idoso , Infecções Relacionadas à Prótese/cirurgia , Infecções Relacionadas à Prótese/microbiologia , Infecções Relacionadas à Prótese/diagnóstico , Infecções Relacionadas à Prótese/mortalidade , Pessoa de Meia-Idade , Resultado do Tratamento , Desfibriladores Implantáveis/efeitos adversos , Sucção , Marca-Passo Artificial/efeitos adversos , Marca-Passo Artificial/microbiologia , Endocardite Bacteriana/cirurgia , Endocardite Bacteriana/microbiologia , Endocardite Bacteriana/diagnóstico , Endocardite Bacteriana/mortalidade , Endocardite Bacteriana/etiologia , Estudos Retrospectivos , Fatores de Tempo , Fatores de Risco , Idoso de 80 Anos ou maisRESUMO
AIMS: Transvenous lead extraction (TLE) is potentially complicated by significant tricuspid valve regurgitation increase (TRI). However, there are limited data on the effect of the bidirectional rotational mechanical sheaths on significant TRI. The aim of the present study was to investigate the rate of significant changes in tricuspid regurgitation (TR) severity following mechanical rotational TLE and their outcomes. METHODS AND RESULTS: In 158 patients (mean age 66 ± 16.9 years) undergoing mechanical rotational TLE, acute changes in TR severity were assessed by echocardiography evaluation. A significant acute TRI was defined as an increase of at least one grade with a post-extraction severity at least moderate. A total of 290 leads were extracted (mean implant duration, 93 ± 65 months). Significant TRI was noted in 5.7% of patients, and it was linked to tricuspid valve damage, TLE infection indication, and longer lead implant duration. Univariate predictors of significant TRI included implant duration of all leads [odds ratio (OR) 1.01; 95% confidence interval (CI) 1.003-1.018; P = 0.001] and right ventricular leads (OR 1.01; 95% CI 1.004-1.017; P = 0.002). Severe increase of TR following TLE was an independent predictor of mortality [hazard ratio (HR) 5.20; 95% CI 1.44-18.73; P = 0.012 ] along with severe systolic dysfunction (HR 2.37; 95% CI 1.01-5.20; P = 0.032), and systemic infection (HR 2.28; 95% CI 1.06-4.89; P = 0.035). CONCLUSION: Significant TRI was detected in 5.7% of patients following transvenous rotational mechanical lead extraction. The duration of lead implantation emerged as the sole predictor of significant TRI. Physicians engaged in TLE should exercise greater vigilance for this potential complication.
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Desfibriladores Implantáveis , Remoção de Dispositivo , Insuficiência da Valva Tricúspide , Humanos , Insuficiência da Valva Tricúspide/etiologia , Masculino , Feminino , Remoção de Dispositivo/efeitos adversos , Idoso , Pessoa de Meia-Idade , Desfibriladores Implantáveis/efeitos adversos , Idoso de 80 Anos ou mais , Índice de Gravidade de Doença , Fatores de Risco , Resultado do Tratamento , Marca-Passo Artificial/efeitos adversos , Estudos Retrospectivos , Valva Tricúspide/diagnóstico por imagem , Valva Tricúspide/cirurgia , Valva Tricúspide/fisiopatologia , Fatores de TempoRESUMO
BACKGROUND: Long-term outcomes of sterile lead management strategies of lead abandonment (LA) or transvenous lead extraction (TLE) remain unclear. METHODS: We performed a retrospective study of a population residing in southeastern Minnesota with follow-up at the Mayo Clinic and its health systems. Patients who underwent LA or TLE of sterile leads from January 1, 2000, to January 1, 2011, and had follow-up for at least 10 years or until their death were included. RESULTS: A total of 172 patients were included in the study with 153 patients who underwent LA and 19 who underwent TLE for sterile leads. Indications for subsequent lead extraction arose in 9.1% (n = 14) of patients with initial LA and 5.3% (n = 1) in patients with initial TLE, after an average of 7 years. Moreover, 28.6% of patients in the LA cohort who required subsequent extraction did not proceed with the extraction, and among those who proceeded, 60% had clinical success and 40% had a clinical failure. Subsequent device upgrades or revisions were performed in 18.3% of patients in the LA group and 31.6% in the TLE group, with no significant differences in procedural challenges (5.2% vs. 5.3%). There was no difference in 10-year survival probability among the LA group and the TLE group (p = .64). CONCLUSION: An initial lead abandonment strategy was associated with more complicated subsequent extraction procedures compared to patients with an initial transvenous lead extraction strategy. However, there was no difference in 10-year survival probability between both lead management approaches.
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Remoção de Dispositivo , Humanos , Masculino , Feminino , Estudos Retrospectivos , Idoso , Minnesota/epidemiologia , Desfibriladores Implantáveis , Marca-Passo Artificial , Resultado do Tratamento , Pessoa de Meia-Idade , Eletrodos ImplantadosRESUMO
BACKGROUND: The real-world data on the safety profile of transvenous lead extraction (TLE) for infected cardiac implantable electronic devices (CIED) among elderly patients is not well-established. This study aimed to evaluate the hospital outcomes between patients of different age groups who underwent TLE for infected CIED. METHOD: Using the Nationwide Readmissions Database, our study included patients aged ≥18 years who underwent TLE for infected CIED between 2017 and 2020. We divided the patients into four groups: Group A. Young (<50 years), Group B. Young intermediate (50-69 years old), Group C. Older intermediate (70-79 years old), and Group D. Octogenarian (≥80 years old). We then analyzed the in-hospital outcome and 30-day readmission between these age groups. RESULTS: A total of 10,928 patients who were admitted for TLE of infected CIED were included in this study: 982 (9.0%) patients in group A, 4,234 (38.7%) patients in group B, 3,204 (29.3%) patients in group C and 2,508 (23.0%) of patients in group D. Our study demonstrated that the risk of early mortality increased with older age (Group B vs. Group A: OR: 1.92, 95% CI: 1.19-3.09, p < .01; Group C vs. Group A: OR: 2.47, 95% CI: 1.51-4.04, p < .01; Group D vs. Group A: OR: 2.82, 95% CI: 1.69-4.72, p < .01). The risk of non-home discharge also increased in elderly groups (Group B vs. Group A: OR: 1.89; 95% CI: 1.52-2.36; p < .01; Group C vs. Group A: OR: 2.82; 95% CI 2.24-3.56; p < .01; Group D vs. Group A: OR: 4.16; 95% CI: 3.28-5.28; p < .01). There was no significant difference in hospitalization length and 30-day readmission between different age groups. Apart from a higher rate of open heart surgery in group A, the procedural complications were comparable between these age groups. CONCLUSION: Elderly patients had worse in-hospital outcomes in early mortality and non-home discharge following the TLE for infected CIED. There was no significant difference between elderly and non-elderly groups in prolonged hospital stay and 30-day readmission. Elderly patients did not have a higher risk of procedural complications.
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Desfibriladores Implantáveis , Marca-Passo Artificial , Idoso , Idoso de 80 Anos ou mais , Humanos , Adolescente , Adulto , Pessoa de Meia-Idade , Desfibriladores Implantáveis/efeitos adversos , Marca-Passo Artificial/efeitos adversos , Remoção de Dispositivo/efeitos adversos , Fatores de Risco , Hospitais , Resultado do Tratamento , Estudos RetrospectivosRESUMO
BACKGROUND: Transvenous lead extraction (TLE) for cardiovascular implantable electronic device (CIED)-related infections has increased. The incidence of TLE in nonagenarians is low, with limited reports outlining the outcomes of this procedure. Therefore, in this study, we aimed to clarify the outcomes of TLE in nonagenarians. METHODS: Patients with TLE treated at our hospital between 2014 and 2023 were retrospectively examined; patient characteristics, device type, indications, procedures, complications, and clinical data of nonagenarians were analyzed. RESULTS: Of 12 patients with 24 leads (active fixation lead, n = 11; passive fixation lead, n = 13) who underwent TLE, the indication for TLE was infection (pocket infection, n = 8; sepsis, n = 4). Methicillin-resistant Staphylococcus epidermidis was the most frequently identified causative agent (n = 4). The median patient age was 91 years; five patients were female. The median lead dwell time was 9 years. Excimer laser sheath (16 leads), mechanical sheath (five leads), Evolution RL (one lead), and manual traction (two leads) were employed in TLE. The procedure was successful in all patients, and only one had a minor complication. Six patients required CIED re-implantation, and leadless pacemakers were selected for five patients. The 30-day mortality after TLE was 0%. CONCLUSION: TLE can be safely performed in nonagenarians. The decision to perform TLE should not be based on old age alone; the suitability of removing infected CIEDs should be determined based on each patient's condition.
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INTRODUCTION: Infections associated with cardiac implantable electronic devices (CIEDs) are a multifactorial disease that leads to increased morbidity and mortality. OBJECTIVE: The aim was to analyze patient-, disease- and treatment-related characteristics including microbiological and bacterial spectrum according to survival status and to identify risk factors for 1- and 3-year mortality in patients with local and systemic CIED infection. METHODS: In a retrospective cohort study, we analyzed data from patients with CIED-related local or systemic infection undergoing successful transvenous lead extraction (TLE). Survival status as well as incidence and cause of rehospitalization were recorded. Microbiology and antibiotics used as first-line therapy were compared according to mortality. Independent risk factors for 1- and 3-year mortality were determined. RESULTS: Data from 243 Patients were analyzed. In-hospital mortality was 2.5%. Mortality rates at 30 days, 1- and 3 years were 4.1%, 18.1% and 30%, respectively. Seventy-four (30.5%) patients had systemic bacterial infection. Independent risk factors for 1-year mortality included age (OR 1.05 [1.01-1.10], p = 0.014), NT-proBNP at admission (OR 4.18 [1.81-9.65], p = 0.001), new onset or worsened tricuspid regurgitation after TLE (OR 6.04 [1.58-23.02], p = 0.009), and systemic infection (OR 2.76 [1.08-7.03], p = 0.034), whereas systemic infection was no longer an independent risk factor for 3-year mortality. Staphylococcus aureus was found in 18.1% of patients who survived and in 25% of those who died, p = 0.092. There was a high proportion of methicillin-resistant strains among coagulase-negative staphylococci (16.5%) compared to Staphylococcus aureus (1.2%). CONCLUSIONS: Staphylococci are the most common causative germs of CIED-infection with coagulase-negative staphylococci showing higher resistance rates to antibiotics. The independent risk factors for increased long-term mortality could contribute to individual risk stratification and well-founded treatment decisions in clinical routine. Especially the role of tricuspid regurgitation as a complication after TLE should be investigated in future studies.
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Antibacterianos , Desfibriladores Implantáveis , Remoção de Dispositivo , Mortalidade Hospitalar , Marca-Passo Artificial , Infecções Relacionadas à Prótese , Humanos , Masculino , Feminino , Estudos Retrospectivos , Infecções Relacionadas à Prótese/microbiologia , Infecções Relacionadas à Prótese/mortalidade , Infecções Relacionadas à Prótese/diagnóstico , Infecções Relacionadas à Prótese/epidemiologia , Idoso , Desfibriladores Implantáveis/efeitos adversos , Fatores de Risco , Marca-Passo Artificial/efeitos adversos , Antibacterianos/uso terapêutico , Mortalidade Hospitalar/tendências , Pessoa de Meia-Idade , Incidência , Idoso de 80 Anos ou mais , Fatores de Tempo , Taxa de Sobrevida/tendênciasRESUMO
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 AND AIMS: The rate of cardiac implantable electronic device (CIED) implantations and the need for transvenous lead extraction (TLE) are growing worldwide. This study examined a large Swedish cohort with the aim of identifying possible predictors of post-TLE mortality with special focus on systemic infection patients and frailty. METHODS: This was a single centre study. Records of patients undergoing TLE between 2010 and 2018 were analysed. Statistical analyses were conducted to compare baseline characteristics of patients with different indications and identify risk factors of 30-day and 1-year mortality. RESULTS: A total of 893 patients were identified. Local infection was the dominant indication and pacemaker was the most common CIED. The mean age was 65 ± 16 years, 73 % were male and median follow-up was 3.9 years. Heart failure was the most common comorbidity. Patients with systemic infection were significantly older, frailer and had significantly higher levels of comorbidities. 30-day mortality and 1-year mortality rates were 2.5 % and 9.9 %, respectively. Systemic infection and chronic kidney disease (CKD) were independently associated with 30-day and 1-year mortality. Clinical frailty scale (CFS) 5-7 correlated independently with 1-year mortality in the entire cohort and specifically in systemic infection patients. CKD, cardiac resynchronization therapy and CFS 5-7 were significant risk factors for long-term mortality (death >1 year after TLE) in multivariable analysis. CONCLUSIONS: Systemic infection, kidney failure in addition to the novel parameter of frailty were associated with post-TLE all-cause mortality. These risk factors should be considered during pre-procedure risk stratification to improve post-TLE outcomes.
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INTRODUCTION: Transvenous lead extraction has become a frequent procedure in the context of device lead management and various tools are available. The aim of this study was to investigate the efficacy and safety of the novel short rotating dilator sheath TightRailTM Sub-C (Sub-C) in transvenous lead extraction. METHODS: For this retrospective single-center analysis, we included consecutive patients undergoing transvenous lead extraction using the Sub-C from January 2018 until February 2020 at the University Heart Center Zurich. RESULTS: A total of 87 leads were extracted within 45 patients using the Sub-C extraction sheath. The mean dwell time of the leads was 112 ± 9.1 months. Complete procedural success was achieved in 95.6% (43/45) and clinical procedural success in 97.8% (44/45). Two major complications (4.4%, 2/45) occurred, but neither was directly related to the Sub-C. CONCLUSION: This retrospective single-center analysis suggests that transvenous lead extraction with a routine use of the TightRailTM Sub-C extraction sheath is a safe strategy resulting in high success rates that may offer useful theoretical benefits. Future studies are needed to evaluate the incremental benefit of a routine use of short extraction sheaths including the Sub-C during TLE procedures.
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Desfibriladores Implantáveis , Marca-Passo Artificial , Humanos , Estudos Retrospectivos , Remoção de Dispositivo/métodos , Desenho de Equipamento , Falha de Equipamento , Resultado do TratamentoRESUMO
INTRODUCTION: Lead dwell time >10 years is a recognized predictor for transvenous lead extraction (TLE) failure and complications. Data on the efficacy and safety of TLE using the bidirectional rotational mechanical sheaths in patients with very old leads are lacking. In this multicenter study, we reported the outcomes of transvenous rotational mechanical lead extraction in patients with leads implanted for ≥10 years. METHODS: A total of 441 leads (median: 159 months [135-197]; range: 120-487) in 189 consecutive patients were removed with the Evolution RL sheaths (Cook Medical, Bloomingtom, IN, USA) and mechanical ancillary tools supporting the procedures. RESULTS: The main indication for TLE was infection in 74% of cases. Complete procedural success rate, clinical success rate, per lead were 94.8% and 98.2%, respectively. Failure of lead extraction was seen in 1.8% of leads. The additional use of a snare via the femoral approach was required in 9% of patients. Lead dwell time was the only predictor of incomplete led removal (odds ratio: 1.009; 95% confidence interval [CI]: 1.003-1.014; p = .002). Four major complication (2%) were encountered. During a mean time follow-up of 31 ± 27 months, 21 patients (11%) died. No procedure-related mortality occurred. Predictors of mortality included severe left ventricular systolic dysfunction (hazard ratio [HR]: 8.06; 95% CI: 2.99-21.73; p = .001), TLE for infection (HR: 8.0; 95% CI: 1.04-62.5; p = .045), diabetes (HR: 3.7; 95% CI: 1.48-9.5; p = .005), and previous systemic infection (HR: 3.1; 95% CI: 1.17-8.24; p = .022). Incomplete lead removal or failure lead extraction did not impact on survival during follow-up. CONCLUSION: Our findings demonstrated that the use of bidirectional rotational TLE mechanical sheaths combined with different mechanical tools and femoral approach allows reasonable success and safety in patients with very old leads at experienced specialized centers.
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Desfibriladores Implantáveis , Marca-Passo Artificial , Humanos , Remoção de Dispositivo/métodos , Eletrodos Implantados , Estudos Retrospectivos , Resultado do TratamentoRESUMO
INTRODUCTION: Transvenous lead extraction (TLE) is a crucial procedure for managing cardiac implantable electronic devices. The use of a combined superior and femoral approach has been found to enhance the success rate of TLE. This report introduces a novel technique, named "Wire ThRoUgh Snare Twice" (Wire TRUST), for effectively grasping a lead without a free end during TLE. METHOD: The Wire TRUST technique was applied in a case involving a 49-year-old male patient requiring TLE due to electrical artifact on the right ventricular (RV) lead, replacement of the RV lead, and pacemaker generator exchange. The Wire TRUST technique involved the insertion of a 4-Fr pigtail catheter and a 6-Fr snare catheter through the 14-Fr sheath inserted from the right common femoral vein. The 4-Fr pigtail catheter was hooked to the RV lead under multidirectional fluoroscopic guidance in the right atrium. The 0.014-in. guidewire was advanced through the pigtail catheter, crossing the RV lead until reaching the inferior vena cava. Subsequently, the distal end of the 0.014-in. guidewire was captured using a snare and pulled, facilitating externalization of the guidewire. After externalization, both ends of the 0.014-in. guidewire were passed through the snare outside the body and reinserted into the 14-Fr sheath. By simultaneously advancing and closing the snare while applying tension to the 0.014-in. guidewire, a secure grip on the lead without free ends was achieved. RESULTS: The Wire TRUST technique enabled successful lead extraction and replacement without any complications. The technique facilitated the co-axial alignment of the powered sheath with the RV lead, ensuring safe and efficient extraction. CONCLUSION: The Wire TRUST technique presents a novel and effective approach for grasping leads with inaccessible ends during TLE.
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Marca-Passo Artificial , Masculino , Humanos , Pessoa de Meia-Idade , Cateterismo Cardíaco , Ventrículos do Coração , Remoção de Dispositivo/métodosRESUMO
BACKGROUND AND AIMS: Transvenous lead extraction (TLE) has become a pivotal part of a comprehensive lead management strategy, dealing with a continuously increasing demand. Nonetheless, the literature about the long-term impact of TLE on survivals is still lacking. Given these knowledge gaps, the aim of our study was to analyse very long-term mortality in patients undergoing TLE in public health perspective. METHODS: This prospective, single-centre, observational study enrolled consecutive patients with cardiac implantable electronic device (CIED) who underwent TLE, from January 2005 to January 2021. The main goal was to establish the independent predictors of very long-term mortality after TLE. We also aimed at assessing procedural and hospitalization-related costs. RESULTS: We enrolled 435 patients (mean age 70 ± 12 years, with mean lead dwelling time 6.8 ± 16.7 years), with prevalent infective indication to TLE (92%). Initial success of TLE was achieved in 98% of population. After a median follow-up of 4.5 years (range: 1 month-15.5 years), 150 of the 435 enrolled patients (34%) died. At multivariate analysis, death was predicted by: age (≥77 years, OR: 2.55, CI: 1.8-3.6, p < 0.001), chronic kidney disease (CKD) defined as severe reduction of estimated glomerular filtration rate (eGFR <30 mL/min/1.73 m2 , OR: 1.75, CI: 1.24-2.4, p = 0.001) and systolic dysfunction assessed before TLE defined as left ventricular ejection fraction (LVEF) <40%, OR: 1.78, CI 1.26-2.5, p = 0.001. Mean extraction cost was 5011 per patient without reimplantation and 6336 per patient with reimplantation respectively. CONCLUSIONS: Our study identified three predictors of long-term mortality in a high-risk cohort of patients with a cardiac device infection, undergoing successful TLE. The future development of a mortality risk score before might impact on public health strategy.
Assuntos
Desfibriladores Implantáveis , Humanos , Pessoa de Meia-Idade , Idoso , Idoso de 80 Anos ou mais , Desfibriladores Implantáveis/efeitos adversos , Estudos Prospectivos , Volume Sistólico , Função Ventricular Esquerda , Fatores de Risco , Resultado do Tratamento , Estudos RetrospectivosRESUMO
AIMS: Female sex is a recognized risk factor for procedure-related major complications including in-hospital mortality following transvenous lead extraction (TLE). Long-term outcomes following TLE stratified by sex are unclear. The purpose of this study was to evaluate factors influencing long-term survival in patients undergoing TLE according to sex. METHODS AND RESULTS: Clinical data from consecutive patients undergoing TLE in the reference centre between 2000 and 2019 were prospectively collected. The total cohort was divided into groups based on sex. We evaluated the association of demographic, clinical, device-related, and procedure-related factors on long-term mortality. A total of 1151 patients were included, with mean 66-month follow-up and mortality of 34.2% (n = 392). The majority of patients were male (n = 834, 72.4%) and 312 (37.4%) died. Males were more likely to die on follow-up [hazard ratio (HR) = 1.58 (1.23-2.02), P < 0.001]. Males had a higher mean age at explant (66.2 ± 13.9 vs. 61.3 ± 16.3 years, P < 0.001), greater mean co-morbidity burden (2.14 vs. 1.27, P < 0.001), and lower mean left ventricular ejection fraction (LVEF) (43.4 ± 14.0 vs. 50.8 ± 12.7, P = 0.001). For the female cohort, age > 75 years [HR = 3.45 (1.99-5.96), P < 0.001], estimated glomerular filtration rate < 60 [HR = 1.80 (1.03-3.11), P = 0.037], increasing co-morbidities (HR = 1.29 (1.06-1.56), P = 0.011), and LVEF per percentage increase [HR = 0.97 (0.95-0.99), P = 0.005] were all significant factors predicting mortality. The same factors influenced mortality in the male cohort; however, the HRs were lower. CONCLUSION: Female patients undergoing TLE have more favourable long-term outcomes than males with lower long-term mortality. Similar factors influenced mortality in both groups.
Assuntos
Desfibriladores Implantáveis , Marca-Passo Artificial , Humanos , Masculino , Feminino , Idoso , Desfibriladores Implantáveis/efeitos adversos , Volume Sistólico , Função Ventricular Esquerda , Fatores de Risco , Comorbidade , Remoção de Dispositivo/efeitos adversos , Marca-Passo Artificial/efeitos adversos , Estudos Retrospectivos , Resultado do TratamentoRESUMO
AIMS: Transvenous lead extraction (TLE) is important in the management of cardiac implantable electronic devices but carries risk. It is most commonly completed from the superior access, often with 'bail-out' support via the femoral approach. Superior and inferior access may be used in tandem, which has been proposed as an advance in safety and efficacy. The aim of this study is to evaluate the safety and efficacy of the Tandem approach. METHOD: The 'Tandem' procedure entailed grasping of the targeted lead in the right atrium to provide countertraction as a rotational dissecting sheath was advanced over the lead from the subclavian access. Consecutive 'Tandem' procedures performed by a single operator between December 2020 and March 2023 in a single large-volume TLE centre were included and compared with the conventional superior approach (control) using 1:1 propensity score matching; patients were statistically matched for demographics. RESULTS: The Tandem in comparison with the conventional approach extracted leads of much greater dwell time (148.9 ± 79 vs. 108.6 ± 77 months, P < 0.01) in a shorter procedure duration (96 ± 36 vs. 127 ± 67â min, P < 0.01) but requiring more fluoroscopy (16.4 ± 10.9 vs. 10.8 ± 14.9â min, P < 0.01). The Tandem and control groups had similar clinical (100% vs. 94.7%, P = 0.07) and complete (94.8% vs. 92.8%, P = 0.42) success, with comparable minor (4% vs. 6.7%, P = 0.72) and major (0% vs. 4%, P = 0.25) complications; procedural (0% vs. 1.3%, P = 1) and 30-day (1.3% vs. 4%, P = 0.62) mortality were also similar. CONCLUSION: The Tandem procedure is as safe and effective as the conventional TLE. It can be applied to leads of a long dwell time with a potentially shorter procedure duration.