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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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BACKGROUND: Limited data are available on leadless pacemaker (LPM) outcomes according to different stages of chronic kidney disease (CKD). OBJECTIVE: To investigate differences regarding safety and efficacy in LPMs patients stratified per different stages of renal function. METHODS: Consecutive patients enrolled in the multicenter, international i-LEAPER registry were analyzed. Patients were divided into three groups according to CKD stage. The primary endpoint was the comparison of LPM-related major complication rate at implant and during follow-up. Differences in electrical performance were deemed secondary outcomes. RESULTS: Among 1748 patients enrolled, 33% were CKD stage G3a/G3b and 9.4% were CKD stage G4/G5. CKD patients presented cardiovascular comorbidities more frequently. During a median follow-up of 39 [interquartile range (IQR) 18-59] months, major complications rate did not differ between groups (normal kidney function, NKF=1.8% vs CKD stage-G3a/G3b 2.9% vs CKD stage-G4/G5 2.4%, p=0.418). All-cause mortality resulted higher in CKD stage-G4/G5 when compared with NKF group (19.5% vs 9.8%, aHR:1.9, 95%CI 1.25-2.89, p=0.003). LPM electrical performance was comparable between groups, except for CKD patients who showed a slightly higher pacing threshold during the 1-month follow-up (NKF group 0.50 [IQR 0.35-0.70]V vs G3a/G3b group 0.56 [IQR 0.38-0.81]V vs G4/G5 group, 0.51 [0.38-0.84]V @0.24 msec, p<.001). CONCLUSION: In a real-world setting, advanced CKD patients who underwent LPM implantation were underrepresented. Although all-cause mortality was higher in end-stage CKD, periprocedural complications and LPM performance were overall comparable between NKF and different stages of CKD, except for higher values of pacing threshold in CKD patients up to first-month follow-up.
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Background: This study aimed to investigate the characteristics and outcomes of patients diagnosed with Brugada syndrome (BrS) who underwent implantable loop recorder (ILR) insertion during routine clinical activity. Methods: We conducted a comprehensive screening of all consecutive patients diagnosed with BrS at our institution. We analyzed baseline clinical characteristics, arrhythmic findings, and outcomes. Results: Out of 147 BrS patients, 42 (29 %) received an ILR, 13 (9 %) underwent implantable cardioverter-defibrillator (ICD) placement, and 92 patients (63 %) continued regular cardiological follow-up. Patients who received an ILR had a higher prevalence of suspected arrhythmic syncope (43 % vs. 22 %, p = 0.012) and tended to be younger (median age 38 years, interquartile range 30-52, vs. 43 years, 35-55, p = 0.044) with a higher presence of SCN5A gene mutations (17 % vs. 6 %, p = 0.066) compared to those who continued regular follow-up. Additionally, compared to patients with an ICD, those with an ILR had a significantly lower frequency of positive programmed ventricular stimulation (0 % vs. 91 %, p < 0.001). During a median follow-up period of 14.7 months (4.7-44.8), no deaths occurred among the patients with ILR. Eight individuals (19 %) were diagnosed with arrhythmic findings through continuous ILR monitoring, primarily atrial fibrillation, and asystolic pauses. The median time from insertion to the occurrence of these events was 8.7 months (3.6-46.4). No adverse events related to ILR were reported. Conclusion: Continuous monitoring with ILR may facilitate the timely detection of non-malignant rhythm disorders in BrS patients with risk factors but without an indication for primary prevention ICD implantation.
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BACKGROUND: Atrial fibrillation (AF) is a common heart rhythm disorder that is associated with an increased risk of stroke and heart failure (HF). Initially, an association between AF and ion channel dysfunction was identified, classifying the pathology as a predominantly electrical disease. More recently it has been recognized that fibrosis and structural atrial remodeling play a driving role in the development of this arrhythmia also in these cases. PURPOSE: Understanding the role of fibrosis in genetic determined AF could be important to better comprise the pathophysiology of this arrhythmia and to refine its management also in nongenetic forms. In this review we analyze genetic and epigenetic mechanisms responsible for AF and their link with atrial fibrosis, then we will consider analogies with the pathophysiological mechanism in nongenetic AF, and discuss consequent therapeutic options.
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Fibrilação Atrial , Insuficiência Cardíaca , Humanos , Fibrilação Atrial/complicações , Átrios do Coração , Fibrose , Canais Iônicos/genética , Canais Iônicos/uso terapêuticoRESUMO
ESC Guidelines don't recommend ICD implantation within 40 days after MI, on the basis of old evidence with several limitations. However, a significant number of patients remain at high risk of arrhythmic death also in the early period after ACS, in these patients early ICD implantation or LifeVest may be use with benefit on survival.
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Desfibriladores Implantáveis , Infarto do Miocárdio , Humanos , Infarto do Miocárdio/terapia , Fatores de Tempo , Morte Súbita Cardíaca/prevenção & controleRESUMO
BACKGROUND: A complex transvenous lead extraction (TLE) procedure could be associated with lower success and higher complication rates in inexperienced hands. In this study, we aim to assess the factors that determine procedural difficulty in TLE. METHODS: We retrospectively studied 200 consecutive patients undergoing TLE in a single referral centre from June 2020 to December 2021. Lead extraction difficulty was assessed by the success of simple manual traction with or without a locking stylet, the need for advanced extraction tools and the number of tools required to extract the lead. Logistic and linear regression analyses were used to determine the factors independently affecting these 3 parameters. RESULTS: 363 leads were extracted from 200 patients (79% males, mean age 66.85 years). The indication for TLE was device-related infection in 51.5%. Multivariate analysis revealed the lead indwelling time to be the only factor affecting the 3 parameters of difficulty. Passive fixation leads and dual coil leads increased procedural difficulty by affecting 2 parameters each. Factors that affected one parameter included infected leads, coronary sinus leads, older age of the patient and a history of valvular heart disease, all associated with a simpler procedure. Right ventricular leads were associated with a more complex one. CONCLUSION: The most important factor that increased TLE procedural difficulty was a longer lead indwelling time, followed by passive fixation and dual-coil leads. Other contributing factors were the presence of infection, coronary sinus leads, older patients, a history of valvular heart disease and right ventricular leads.
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BACKGROUND: Transvenous lead extraction (TLE) has shown a safe and efficacy profile in the intraoperative and short-term setting; however, data on long-term outcomes are limited. OBJECTIVE: The purpose of this study was to assess long-term outcomes and prognostic factors in patients who underwent TLE. METHODS: Consecutive patients with cardiac implantable electronic device (CIED) who underwent TLE between 2014 and 2016 were retrospectively studied. The primary outcome was the composite endpoint of death and repeated TLE stratified by infective/non-infective indication. Individual components of the primary outcome were also evaluated. RESULTS: One hundred ninety-one patients were included in the analysis, 50% extracted for CIED-related infection. Complete procedural success was achieved in 189 patients (99%) with no major acute complications. After a median of 6.5 years, infection indication was associated with significantly lower event-free survival (67% vs. 83% non-infection group, adjusted hazard ratio [aHR] 1.97, 95% confidence interval [CI] 1.02-3.81, p = 0.04). All-cause mortality rate was higher in the TLE infection group (30% vs. 10%, p < 0.01). The rate of repeated TLE did not differ between groups (4% vs. 7%, p = 0.62). Among patients who had TLE for infection, the presence of vegetation (aHR 2.56; 95%CI 1.17-5.63, p = 0.02) and positive blood cultures (aHR 2.64; 95%CI 1.04-6.70, p = 0.04) were independently associated with the primary outcome. CONCLUSION: Patients who underwent TLE for CIED-related infection exhibit a high mortality risk during long-term follow-up. Vegetation and positive blood cultures in patients with CIED-related infection are associated with a worse prognosis regardless of successful and uncomplicated TLE.
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Desfibriladores Implantáveis , Marca-Passo Artificial , Humanos , Desfibriladores Implantáveis/efeitos adversos , Estudos Retrospectivos , Centros de Atenção Terciária , Remoção de Dispositivo , Marca-Passo Artificial/efeitos adversos , Resultado do TratamentoRESUMO
BACKGROUND: Limited data on the real-world safety and efficacy of leadless pacemakers (LPMs) post-transvenous lead extraction (TLE) are available. OBJECTIVE: The purpose of this study was to assess the long-term safety and effectiveness of LPMs following TLE in comparison with LPMs de novo implantation. METHODS: Consecutive patients who underwent LPM implantation in 12 European centers joining the International LEAdless PacemakEr Registry were enrolled. The primary end point was the comparison of LPM-related complication rate at implantation and during follow-up (FU) between groups. Differences in electrical performance were deemed secondary outcomes. RESULTS: Of the 1179 patients enrolled, 15.6% underwent a previous TLE. During a median FU of 33 (interquartile range 24-47) months, LPM-related major complications and all-cause mortality did not differ between groups (TLE group: 1.6% and 5.4% vs de novo group: 2.2% and 7.8%; P = .785 and P = .288, respectively). Pacing threshold (PT) was higher in the TLE group at implantation and during FU, with very high PT (>2 V@0.24 ms) patients being more represented than in the de novo implantation group (5.4% vs 1.6 %; P = .004). When the LPM was deployed at a different right ventricular (RV) location than the one where the previous transvenous RV lead was extracted, a lower proportion of high PT (>1-2 V@0.24 ms) patients at implantation, 1-month FU, and 12-month FU (5.9% vs 18.2%, P = .012; 3.4% vs 12.9%, P = .026; and 4.3% vs 14.5%, P = .037, respectively) was found. CONCLUSION: LPMs showed a satisfactory safety and efficacy profile after TLE. Better electrical parameters were obtained when LPMs were implanted at a different RV location than the one where the previous transvenous RV lead was extracted.
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Marca-Passo Artificial , Humanos , Resultado do Tratamento , Marca-Passo Artificial/efeitos adversos , Estimulação Cardíaca Artificial/efeitos adversos , Sistema de Registros , Desenho de EquipamentoRESUMO
INTRODUCTION: The prevalence and impact of pulmonary embolism (PE) in patients with lead-related infective endocarditis undergoing transvenous lead extraction (TLE) are unknown. METHODS: Twenty-five consecutive patients with vegetations ≥10 mm at transoesophageal echocardiography were prospectively studied. Contrast-enhanced chest computed tomography (CT) was performed before (pre-TLE) and after (post-TLE) the lead extraction procedure. RESULTS: Pre-TLE CT identified 18 patients (72%) with subclinical PE. The size of vegetations in patients with PE did not differ significantly from those without (median 20.0 mm [interquartile range: 13.0-30.0] vs. 14.0 mm [6.0-18.0], p = 0.116). Complete TLE success was achieved in all patients with 3 (2-3) leads extracted per procedure. There were no postprocedure complications related to the presence of PE and no differences in terms of fluoroscopy time and need for advanced tools. In the group of positive pre-TLE CT, post-TLE scan confirmed the presence of silent PE in 14 patients (78%). There were no patients with new PE formation. Large vegetations (≥20 mm) tended to increase the risk of post-TLE subclinical PE (odds ratio 5.99 [95% confidence interval (CI): 0.93-38.6], p = 0.059). During a median 19.4 months follow-up, no re-infection of the implanted system was reported. Survival rates in patients with and without post-TLE PE were similar (hazard ratio: 1.11 [95% CI: 0.18-6.67], p = 0.909). CONCLUSION: Subclinical PE detected by CT was common in patients undergoing TLE with lead-related infective endocarditis and vegetations but was not associated with the complexity of the procedure or adverse outcomes. TLE procedure seems safe and feasible even in patients with large vegetations.
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Desfibriladores Implantáveis , Endocardite Bacteriana , Endocardite , Marca-Passo Artificial , Infecções Relacionadas à Prótese , Embolia Pulmonar , Desfibriladores Implantáveis/efeitos adversos , Remoção de Dispositivo/métodos , Endocardite/diagnóstico por imagem , Endocardite/epidemiologia , Endocardite Bacteriana/diagnóstico por imagem , Endocardite Bacteriana/epidemiologia , Humanos , Marca-Passo Artificial/efeitos adversos , Prevalência , Infecções Relacionadas à Prótese/diagnóstico por imagem , Infecções Relacionadas à Prótese/epidemiologia , Infecções Relacionadas à Prótese/etiologia , Embolia Pulmonar/diagnóstico por imagem , Embolia Pulmonar/epidemiologia , Embolia Pulmonar/terapia , Estudos RetrospectivosRESUMO
BACKGROUND: Transvenous lead extraction is the standard therapy for cardiac device-related infection. In some patients, however, a hybrid surgical and transvenous approach may be necessary. METHODS AND RESULTS: We present three cases who underwent transvenous lead extraction for an infected CRT-D system. In all cases the CS lead could not be retrieved transvenously due to extensive fibrosis. The lead was successfully extracted through left minithoracotomy in two patients and midline sternotomy in one patient. CONCLUSION: In cases where the coronary sinus lead shows severe fibrosis, a transvenous approach can be used to free the proximal part of the lead, while the distal adhesions can be removed surgically through a limited thoracic incision.
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Seio Coronário , Desfibriladores Implantáveis , Seio Coronário/cirurgia , Remoção de Dispositivo , Fibrose , Humanos , Toracotomia , Resultado do TratamentoRESUMO
Superior vena cava (SVC) syndrome is a rare disease induced by thrombosis and consequent occlusion of SVC, negatively affecting morbidity and mortality. The incidence of SVC syndrome from central venous catheters and pacemaker or defibrillator leads is increasing. Optimal treatment of pacemaker or defibrillator-related SVC syndrome is not well defined. Lead extraction causes mechanical trauma to the vessel wall. In addition, subsequent device implantation on the contralateral side can be an added factor for venous occlusion. The use of leadless pacemakers could be an interesting option to reduce the risk of SVC restenosis after lead extraction. We report a clinical case of PM leads-related SVC syndrome referred to our centers and treated with transvenous lead extraction, leadless pacemaker implantation and subsequent percutaneous angioplasty and stenting of the SVC and left innominate vein.
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Marca-Passo Artificial , Síndrome da Veia Cava Superior , Trombose , Humanos , Marca-Passo Artificial/efeitos adversos , Stents/efeitos adversos , Síndrome da Veia Cava Superior/cirurgia , Síndrome da Veia Cava Superior/terapia , Trombose/complicações , Veia Cava SuperiorRESUMO
INTRODUCTION: We hypothesized that an accurate assessment of preoperative venography could be useful in predicting transvenous lead extraction (TLE) difficulty. METHODS AND RESULTS: A dedicated preoperative venogram was performed in consecutive patients with cardiac implantable electronic device who underwent TLE. The level of stenosis was classified as without significant stenosis, moderate, severe, and occlusion. The presence of extensive lead-venous wall adherence (≥50 mm) was also assessed. A total of 105 patients (median age: 71 years; 72% male) with a median of 2 (1-2) leads to extract were enrolled. Preoperative venography showed moderate to severe stenosis in 31 (30%), complete occlusion in 15 (14%), and extensive lead-venous wall adherence in 50 (48%) patients. Complete TLE success was achieved in 103 (98%) patients. A total of 55 (52%) were advanced extractions as they required a powered mechanical and/or laser sheath. They were more prevalent in the group with extensive lead-venous wall adherence (72% vs. 34%, p < .001), while no differences were found between patients with and without venous occlusion. In multivariate analysis, the presence of adherence was a predictor of advanced extraction (odds ratio: 2.89 [1.14-7.32], p = .025). The fluoroscopy time was also significantly longer (14.0 [8.2-18.7] vs. 5.1 [2.1-10.0] min, p < .001). The rate of complications did not differ based on the presence of venous lesions. CONCLUSION: Although procedural success and complication rates were similar, patients with extensive lead-venous wall adherence required a longer fluoroscopy time and were three times more likely to need advanced extraction tools. Conversely, the presence of total venous occlusion had no impact on the procedure complexity.
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Desfibriladores Implantáveis , Marca-Passo Artificial , Doenças Vasculares , Idoso , Constrição Patológica , Remoção de Dispositivo/efeitos adversos , Remoção de Dispositivo/métodos , Feminino , Humanos , Masculino , Flebografia , Estudos Retrospectivos , Resultado do TratamentoRESUMO
PURPOSE: High pacing threshold (HPT) and very high pacing threshold (VHPT) are known to have a negative impact on leadless pacemaker battery longevity, representing the most common reason for device repositioning. In this study, we evaluated if intraoperative electrical parameters recorded during Micra™ VR implant would be able to predict device performance during follow-up (FU). METHODS: A total of 93 patients undergoing Micra™ VR implant were retrospectively considered. Patients were enrolled in the study if electrical assessment was performed at least twice at implant, at Micra™ final positioning and after removal of the delivery system. All patients received a FU visit at 1 and 12 month after discharge. R-wave sensing amplitude, pacing threshold (PT), and impedance were recorded at each visit. RESULTS: When compared to the first assessment, R-wave sensing amplitude increased by 19.1% after 13 ± 4 min (+ 1.71 ± 0.2 mV, 95% CI 1.4 to 2.02; p < .001). Conversely, there was a significant PT decrease of 22.1% at 12-month FU (- 0.22 ± 0.03 V, 95% CI - 0.13 to - 0.31; p < .001). Among patients with HPT, acute increase of R-wave sensing of 1.5 mV after 14 ± 4 min predicted a significant reduction of PT below 1 V/0.24, at 12-month post-implant (R = 0.72, 95% CI 0.13 to 0.33, p < .001), with a sensitivity of 87.5% (95% CI 0.61-0.98) and a specificity of 88.8% (95% CI 0.51-0.99). CONCLUSION: A 1.5-mV increase in R-wave amplitude at implant is predictive of PT normalization (< 1.0 V/0.24 ms) at 12-month FU. This finding may have practical implications for device repositioning in case of HPT recording at implant.
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Estimulação Cardíaca Artificial , Marca-Passo Artificial , Desenho de Equipamento , Humanos , Estudos Retrospectivos , Resultado do TratamentoAssuntos
Arritmias Cardíacas , COVID-19 , Desfibriladores Implantáveis/estatística & dados numéricos , Exercício Físico , Monitorização Ambulatorial , Marca-Passo Artificial/estatística & dados numéricos , Comportamento Sedentário , Arritmias Cardíacas/diagnóstico , Arritmias Cardíacas/epidemiologia , Arritmias Cardíacas/fisiopatologia , Arritmias Cardíacas/terapia , COVID-19/epidemiologia , COVID-19/prevenção & controle , Exercício Físico/fisiologia , Exercício Físico/estatística & dados numéricos , Humanos , Controle de Infecções/métodos , Monitorização Ambulatorial/métodos , Monitorização Ambulatorial/estatística & dados numéricos , Monitorização Ambulatorial/tendências , Avaliação de Processos e Resultados em Cuidados de Saúde , Tecnologia de Sensoriamento Remoto/métodos , SARS-CoV-2RESUMO
PURPOSE: Predictors of difficulty and complications of transvenous lead extraction (TLE) have been investigated in several studies; however, little is known about the venous anatomical characteristics that can have an impact on procedural outcomes. Among them, the persistent left superior vena cava (PLSVC) is a common anomaly often discovered incidentally during cardiac device implantation and could raise concerns if TLE is indicated. We report technical considerations and outcomes of TLE for two patients with leads implanted via PLSVC. METHODS AND RESULTS: Two cardiac implantable electronic device recipients with isolated PLSVC required TLE due to infective endocarditis in one case and lead failure in the other. In the first case, TLE procedure was performed in a hybrid operating room with minimally invasive video-assisted thoracoscopic monitoring due to the high procedural risk. Two active fixation 20-year-old pacing leads were removed with a relatively short fluoroscopy time. In the second case, we successfully extracted a single-coil active fixation lead without the need of a locking stylet or advanced extraction tools. There were no procedural complications or adverse events at 1-year follow-up. CONCLUSION: TLE procedures for two patients with isolated PLSVC were successfully completed with less difficulty and tools than expected based on the characteristics of the targeted leads. If indicated, TLE in the presence of a PLSVC should be considered in experienced centers.
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Veia Cava Superior Esquerda Persistente , Veia Cava Superior , Remoção de Dispositivo , Fluoroscopia , Humanos , Resultado do Tratamento , Veia Cava Superior/diagnóstico por imagem , Veia Cava Superior/cirurgiaRESUMO
We report the case of a patient implanted with an implantable defibrillator endowed with a multisensor algorithm for heart failure monitoring. Automatic measurement of multiple clinical variables allowed to detect impending heart failure decompensation and showed its ability to facilitate differential diagnosis in the context of the current COVID-19 pandemic.
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PURPOSE: The persistent left superior vena cava (PLSVC) is usually asymptomatic and creates a challenge when detected incidentally during cardiac resynchronization therapy defibrillator (CRT-D) implantation. The purpose of our cases is to show different anatomical variables of PLSVC and different strategies used for CRT-D implantation. METHODS: Four cases of PLSVC were presented. Pre-procedural bilateral venography was done to define anatomical variant of PLSVC. The side of approach and vein of approach were chosen according to the anatomical variant. Major challenges, electrical parameters, procedural times, long-term follow up, and complications were addressed. RESULTS: Two cases were de novo CRT-D implantation. One case was an extraction/re-implantation of the coil lead, and one case was an upgrading. In one case, CRT-D implantation was followed by AVN ablation. All cases had successful devices implantation. Two cases had isolated PLSVC: one of them had right approach and the other had left approach. One case had double SVC with no connecting brachiocephalic veins and underwent a left-sided approach. One case had double SVC with a small connecting brachiocephalic vein and had a left approach for implantation with using the small brachiocephalic vein for the RV lead. Electrical parameters were acceptable for all leads implanted. Long-term follow-up was done for 6 months to 5 years. One complication occurred (acute atrial lead dislodgement). CONCLUSIONS: In our case series, the presence of PLSVC did not preclude successful placement of pacemaker/defibrillator leads using standard tools. Bilateral venography helped to decide the side and vein of lead insertion.
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Terapia de Ressincronização Cardíaca , Veia Cava Superior Esquerda Persistente , Veias Braquiocefálicas , Dispositivos de Terapia de Ressincronização Cardíaca , Humanos , Veia Cava Superior/diagnóstico por imagem , Veia Cava Superior/cirurgiaRESUMO
Theleadless pacemaker (LLPM) therapy has been developed in recent years to overcome the transvenous lead and device pocket-related complications. The LLPMs now available are self-contained right ventricular pacemakers and are limited to single-chamber ventricular pacing modality. This literature review deals with the current status of LLPM technology and current areas of clinical applicability. The safety and efficacy outcomes published from randomized clinical trials and real world registries are analyzed and compared with historical conventional transvenous pacemaker data. Furthermore, new pacing modalities and future perspectives to broaden the clinical use and cover most of pacing indications are discussed. Due to the overall safe and effective profile in the short term and intermediate term, also in fragile patients, the LLPM use is constantly growing in daily clinical practice. Actually, it can be considered a landmark innovation, through which a new era of cardiac pacing has begun.