Transvenous lead extraction, factors affecting procedural difficulty.

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.

Long-term outcomes following transvenous lead extraction: Data from a tertiary referral center.

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.

Outcomes of leadless pacemaker implantation following transvenous lead extraction in high-volume referral centers: Real-world data from a large international registry.

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.

Corrigendum: Predictors of late arrhythmic events after generator replacement in Brugada syndrome treated with prophylactic ICD.

[This corrects the article DOI: 10.3389/fcvm.2022.964694.].

Predictors of late arrhythmic events after generator replacement in Brugada syndrome treated with prophylactic ICD.

Introduction: Predictors of late life-threatening arrhythmic events in Brugada syndrome (BrS) patients who received a prophylactic ICD implantation remain to be evaluated. The aim of the present long-term multicenter study was to assess the incidence and clinical-electrocardiographic predictors of late life-threatening arrhythmic events in BrS patients with a prophylactic implantable cardioverter defibrillator (ICD) and undergoing generator replacement (GR). Methods: The study population included 105 patients (75% males; mean age 45 ± 14years) who received a prophylactic ICD and had no arrhythmic event up to first GR. Results: The median period from first ICD implantation to last follow-up was 155 (128-181) months and from first ICD Implantation to the GR was 84 (61-102) months. During a median follow-up of 57 (38-102) months after GR, 10 patients (9%) received successful appropriate ICD intervention (1.6%/year). ICD interventions included shock on ventricular fibrillation (n = 8 patients), shock on ventricular tachycardia (n = 1 patient), and antitachycardia pacing on ventricular tachycardia (n = 1 patient). At survival analysis, history of atrial fibrillation (log-rank test; P = 0.02), conduction disturbances (log-rank test; P < 0.01), S wave in lead I (log-rank test; P = 0.01) and first-degree atrioventricular block (log-rank test; P = 0.04) were significantly associated with the occurrence of late appropriate ICD intervention. At Cox-regression multivariate analysis, S-wave in lead I was the only independent predictor of late appropriate ICD intervention (HR: 9.17; 95%CI: 1.15-73.07; P = 0.03). Conclusions: The present study indicates that BrS patient receiving a prophylactic ICD may experience late appropriate intervention after GR in a clinically relevant proportion of cases. S-wave in lead I at the time of first clinical evaluation was the only independent predictor of persistent risk of life-threatening arrhythmic events. These findings support the need for GR at the end of service regardless of previous appropriate intervention, mostly in BrS patients with conduction abnormalities.

Lead-related infective endocarditis with vegetations: Prevalence and impact of pulmonary embolism in patients undergoing transvenous lead extraction.

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.

Leadless pacemakers as a new alternative for pacemaker lead-related superior vena cava syndrome: A case report.

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.

Hybrid transvenous and surgical approach for the extraction of coronary sinus leads: A case series.

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.

The role of preoperative venography in predicting the difficulty of a transvenous lead extraction procedure.

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.

Intraoperative sensing increase predicts long-term pacing threshold in leadless pacemakers.

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.

Impact of SMART Pass filter in patients with ajmaline-induced Brugada syndrome and subcutaneous implantable cardioverter-defibrillator eligibility failure: results from a prospective multicentre study.

AIMS: Ajmaline challenge can unmask subcutaneous implantable cardioverter-defibrillator (S-ICD) screening failure in patients with Brugada syndrome (BrS) and non-diagnostic baseline electrocardiogram (ECG). The efficacy of the SMART Pass (SP) filter, a high-pass filter designed to reduce cardiac oversensing (while maintaining an appropriate sensing margin), has not yet been assessed in patients with BrS. The aim of this prospective multicentre study was to investigate the effect of the SP filter on dynamic Brugada ECG changes evoked by ajmaline and to assess its value in reducing S-ICD screening failure in patients with drug-induced Brugada ECGs. METHODS AND RESULTS: The S-ICD screening with conventional automated screening tool (AST) was performed during ajmaline challenge in subjects with suspected BrS. The S-ICD recordings were obtained before, during and after ajmaline administration and evaluated by the means of a simulation model that emulates the AST behaviour with and without SP filter. A patient was considered suitable for S-ICD if at least one sensing vector was acceptable in all tested postures. A sensing vector was considered acceptable in the presence of QRS amplitude >0.5 mV, QRS/T-wave ratio >3.5, and sense vector score >100. Of the 126 subjects (mean age: 42 ± 14 years, males: 61%, sensing vectors: 6786), 46 (36%) presented with an ajmaline-induced Brugada type 1 ECG. Up to 30% of subjects and 40% of vectors failed the screening during the appearance of Brugada type 1 ECG evoked by ajmaline. The S-ICD screening failure rate was not significantly reduced in patients with Brugada ECGs when SP filter was enabled (30% vs. 24%). Similarly, there was only a trend in reduction of vector-failure rate attributable to the SP filter (from 40% to 36%). The most frequent reason for screening failure was low QRS amplitude or low QRS/T-wave ratio. None of these patients was implanted with an S-ICD. CONCLUSION: Patients who pass the sensing screening during ajmaline can be considered good candidates for S-ICD implantation, while those who fail might be susceptible to sensing issues. Although there was a trend towards reduction of vector sensing failure rate when SP filter was enabled, the reduction in S-ICD screening failure in patients with Brugada ECGs did not reach statistical significance. CLINICAL TRIAL REGISTRATION: https://clinicaltrials.gov Unique Identifier NCT04504591.

Use of a novel implantable cardioverter-defibrillator multisensor algorithm for heart failure monitoring in a COVID-19 patient: A case report.

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.

Transvenous lead extraction in patients with persistent left superior vena cava.

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.

Short P-Wave Duration is a Marker of Higher Rate of Atrial Fibrillation Recurrences after Pulmonary Vein Isolation: New Insights into the Pathophysiological Mechanisms Through Computer Simulations.

Background Short ECG P-wave duration has recently been demonstrated to be associated with higher risk of atrial fibrillation (AF). The aim of this study was to assess the rate of AF recurrence after pulmonary vein isolation in patients with a short P wave, and to mechanistically elucidate the observation by computer modeling. Methods and Results A total of 282 consecutive patients undergoing a first single-pulmonary vein isolation procedure for paroxysmal or persistent AF were included. Computational models studied the effect of adenosine and sodium conductance on action potential duration and P-wave duration (PWD). About 16% of the patients had a PWD of 110 ms or shorter (median PWD 126 ms, interquartile range, 115 ms-138 ms; range, 71 ms-180 ms). At Cox regression, PWD was significantly associated with AF recurrence (P=0.012). Patients with a PWD <110 ms (hazard ratio [HR], 2.20; 95% CI, 1.24-3.88; P=0.007) and patients with a PWD ≥140 (HR, 1.87, 95% CI, 1.06-3.30; P=0.031) had a nearly 2-fold increase in risk with respect to the other group. In the computational model, adenosine yielded a significant reduction of action potential duration 90 (52%) and PWD (7%). An increased sodium conductance (up to 200%) was robustly accompanied by an increase in conduction velocity (26%), a reduction in action potential duration 90 (28%), and PWD (22%). Conclusions One out of 5 patients referred for pulmonary vein isolation has a short PWD which was associated with a higher rate of AF after the index procedure. Computer simulations suggest that shortening of atrial action potential duration leading to a faster atrial conduction may be the cause of this clinical observation.

Electrocardiographic imaging of the arrhythmogenic substrate of Brugada syndrome: Current evidence and future perspectives.

Brugada syndrome is responsible for about 20% of sudden cardiac deaths in patients with apparently normal hearts. Basic and clinical research has elucidated some of the mechanisms that are responsible for life-threatening ventricular arrhythmias in this syndrome. Delays in activation and repolarization over the right ventricular outflow tract are the most likely cause of the ECG typical pattern and arrhythmogenesis. Invasive epicardial and endocardial mapping has identified the epicardium as the principal region of interest for these anomalies, and areas of fragmented potentials at invasive mapping are a target for epicardial ablation. Noninvasive mapping systems have been developed to study the epicardial depolarization and repolarization and may be particularly useful in assessing the epicardial arrhythmogenic substrate of Brugada syndrome for both clinical and research purpose. This review focuses on recent advances in this field.

Technical considerations for CRT-D implantation in different varieties of persistent left superior vena cava.

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.

Leadless pacemaker: State of the art and incoming developments to broaden indications.

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.

Arrhythmic safety of hydroxychloroquine in COVID-19 patients from different clinical settings.

AIMS: The aim of the study was to describe ECG modifications and arrhythmic events in COVID-19 patients undergoing hydroxychloroquine (HCQ) therapy in different clinical settings. METHODS AND RESULTS: COVID-19 patients at seven institutions receiving HCQ therapy from whom a baseline and at least one ECG at 48+ h were available were enrolled in the study. QT/QTc prolongation, QT-associated and QT-independent arrhythmic events, arrhythmic mortality, and overall mortality during HCQ therapy were assessed. A total of 649 COVID-19 patients (61.9 ± 18.7 years, 46.1% males) were enrolled. HCQ therapy was administrated as a home therapy regimen in 126 (19.4%) patients, and as an in-hospital-treatment to 495 (76.3%) hospitalized and 28 (4.3%) intensive care unit (ICU) patients. At 36-72 and at 96+ h after the first HCQ dose, 358 and 404 ECGs were obtained, respectively. A significant QT/QTc interval prolongation was observed (P < 0.001), but the magnitude of the increase was modest [+13 (9-16) ms]. Baseline QT/QTc length and presence of fever (P = 0.001) at admission represented the most important determinants of QT/QTc prolongation. No arrhythmic-related deaths were reported. The overall major ventricular arrhythmia rate was low (1.1%), with all events found not to be related to QT or HCQ therapy at a centralized event evaluation. No differences in QT/QTc prolongation and QT-related arrhythmias were observed across different clinical settings, with non-QT-related arrhythmias being more common in the intensive care setting. CONCLUSION: HCQ administration is safe for a short-term treatment for patients with COVID-19 infection regardless of the clinical setting of delivery, causing only modest QTc prolongation and no directly attributable arrhythmic deaths.