Mechanical extraction of implantable cardioverter-defibrillator leads with a dwell time of more than 10 years: insights from a single high-volume centre.

AIMS: To analyze and compare the effectiveness and safety of transvenous lead extraction (TLE) of implantable cardioverter-defibrillator (ICD) leads with a dwell time of >10 years (Group A) vs. younger leads (Group B) using mechanical extraction systems. METHODS AND RESULTS: Between October 2011 and July 2022, we performed TLE in 318 patients. Forty-six (14.4%) extracted ICD leads in 46 (14.5%) patients that had been implanted for >10 years. The median dwell time of all extracted ICD leads was 5.9 years. Cardiovascular implantable electronic device-related infection was an indication for TLE in 31.8% of patients. Complete ICD leads removal and complete procedural success in both groups were similar (95.7% in Group A vs. 99.6% in Group B, P = 0.056% and 95.6% in Group A vs. 99.6% in Group B, P = 0.056, respectively). We did not find a significant difference between major and minor complication rates in both groups (6.5% in Group A vs. 1.5% in Group B and 2.2% in Group A vs. 1.8% in Group B, P = 0.082, respectively). One death associated with the TLE procedure was recorded in Group B. CONCLUSION: The TLE procedures involving the extraction of old ICD leads were effective and safe. The outcomes of ICD lead removal with a dwell time of >10 years did not differ significantly compared with younger ICD leads. However, extraction of older ICD leads required more frequent necessity for utilizing multiple extraction tools, more experience and versatility of the operator, and increased surgery costs.

The electrocardiographic interpretation of ventricular pacing suppression algorithms in the pacemaker.

Algorithms designed to reduce the right ventricular (RV) pacing burden are widely available in modern dual-chamber implantable pacing devices. These algorithms allow the atrioventricular delay for sensed ventricular events to be longer than for ventricular paced events. However, since these features are unique to pacemaker manufacturers, they often produce unfamiliar electrocardiographic (ECG) appearances that suggest pacemaker dysfunction. We describe a Vp suppression algorithm used in Biotronik dual-chamber pacemakers and implantable cardioverter-defibrillator devices.

Thoracic impedance measurement in heart stimulation and cardiac arrhythmias.

The electrocardiogram (ECG) interpretation in patients with implantable cardioverter defibrillator (ICD) is often a puzzling problem. The difficulty of the device function evaluation further increases in the presence of unfamiliar timing cycles and additional functions. We present an interesting ECG with a special function of a Biotronik ICD devices called the thoracic impedance monitoring, and demonstrate its behavior in a patient with atrial fibrillation, pacing beats, ventricular ectopic beats, and couple of ventricular beats. This report shows unexceptional occurrence of tricky ECG finding in patient with Biotronik ICDs.

Transvenous extraction of very old (over 20-year-old) pacemaker leads using mechanical systems: Effectiveness and safety.

OBJECTIVE: To analyze and compare the effectiveness and safety of transvenous lead extraction (TLE) with mechanical systems of pacing leads older than 20 years (group A) versus younger leads (group B). METHODS: We performed TLE of 591 pacing leads in 377 patients. Fifty (8.5%) leads in 43 (11.4%) patients were implanted for equal to or more than 20 years. The mean dwell time of all extracted leads was 8.9 years (range, 0.1-36.0). Infection related to cardiovascular implantable electronic device was an indication for TLE in 18.3% of patients. RESULTS: Complete lead removal and complete procedural success rates were similar between both groups (94.7% in group A vs 97.1% in group B, P = 0.445, and 90.7% in group A vs 95.8% in group B, P = 0.329, respectively). Incomplete lead removal in group A was observed only in leads older than 20 years. Removal of leads in group A was associated with significantly longer fluoroscopy time compared with group B (4.6 vs 1.9 minutes, P < 0.001). We did not find a significant difference in major and minor complication rates between groups (2.3% in group A vs 0.9% in group B and 2.3% in group A vs 2.2% in group B, P = 0.687, respectively). There were no deaths associated with the TLE procedure within 30 days after the procedure in either group. CONCLUSION: This study shows that TLE of leads older than 20 years conducted at an experienced center seems to be comparably safe and effective as extraction of younger leads but requires longer fluoroscopy time.

Analysis of electrical lead failures in patients referred for transvenous lead extraction procedures.

INTRODUCTION: We evaluated the influences of selected factors on electrical lead failure (ELF) occurrence in patients referred for transvenous lead extraction (TLE) procedures. METHODS AND RESULTS: The study cohort consisted of 432 patients referred for TLE procedures due to various indications (42 - lead-dependent infective endocarditis, 47 - pocket infection, 343 - noninfectious indications) with a total of 804 endocardial leads. In the analyzed group, there were 192 patients with ELF, denoted as group ELF(+) (200 malfunctioning endocardial leads). The percentage of women was higher in the ELF(+) group than in the ELF(-) group (42.7% vs 30.0%; P  =  0.006). The ELF(+) patients had more endocardial leads implanted via subclavian vein puncture (80.0% vs 72.4%; P  =  0.032), had more indwelling leads in the cardiovascular system (1.94 vs 1.8; P  =  0.03), were older (68.9 vs 66.0 years old; P  =  0.028), and had better left ventricular ejection fractions than the ELF(-) patients (48.0% vs 40.7%; P < 0.001). The time interval to ELF occurrence was significantly longer for pacing leads than for cardioverter-defibrillator leads (95.7 vs 65.7 months; P  =  0.016). The most important factor associated with ELF was subclavian vein puncture, increasing the risk of ELF occurrence by 2.5-fold and 2.7-fold in the univariate and multivariate Cox proportional hazards regression models, respectively. The presence of a cardioverter-defibrillator lead increased the risk of ELF by 1.9-fold and 2.7-fold in the univariate and multivariate models, respectively. CONCLUSION: The most significant factors predisposing patients to ELF are the lead implantation approach and the presence of a cardioverter-defibrillator lead.

Inhibition and restoration of CRT pacing - What is the mechanism?

The electrocardiogram (ECG) interpretation in patients with cardiac resynchronization therapy (CRT) may be challenging. The difficulty increases if not well-known pacemaker algorithm is turned on. We show a T-wave protection algorithm (LVTP) in a patient with CRT. Accelerated sinus rhythm and intermittent oversensing in left ventricular channel resulted in loss of CRT pacing. The restoration of biventricular pacing occurred when atrial rate decreased. We provide detailed descriptions of the electrocardiogram and intracardiac electrogram. LVTP may confuse ECG examination interpretation, especially in patients with accelerated atrial rhythm and oversensing in left ventricular channel.

Gender differences in dual-chamber pacemaker implantation indications and long-term outcomes.

OBJECTIVE: Dual-chamber (DDD) pacing is the most commonly used mode of heart stimulation. The data on gender-related differences in the long-term follow-up of DDD pacing mode are still limited. We performed a retrospective single-centre study to determine the effect of gender on the implantation indications and the incidence of adverse events resulting in DDD mode loss. METHODS AND RESULTS: A group of 1,049 consecutive patients with DDD pacemaker implanted between 1984 and 2002 were followed up until 2014. The study group consisted of 995 patients who performed at least one follow-up visit. Follow-up period was 124.2 ± 68.3 months, mean age was 63.5 ± 12.4 years, 56% were male. Adverse events were defined as loss of primary DDD stimulation--lead malfunction, progression to permanent AF, and infective complications. Women were older than men (64.7 vs 62.6 years) at the time of implantation and they remained, on average, 1.5 year longer in follow-up compared with men. Female patients had significantly more SSS, history of paroxysmal AF, and a similar percentage of AVB compared with male patients. The incidence of lead malfunction, device-related infections, and progression to permanent AF did not show significant differences. However, in the group without prior paroxysmal AF, women developed permanent AF more frequently. CONCLUSIONS: This patients cohort showed that there is an association between gender and indications to DDD pacing therapy. The rate of adverse events was similar in both genders. Women had a significantly longer duration of follow-up, despite markedly higher age at implantation.

Endocardial lead insulation wear in a scanning and optical microscope.

BACKGROUND: The path and interaction of leads within the cardiovascular system are influenced by various factors, including the implantation technique. Furthermore, the multifaceted composition of these leads, often comprising multiple materials, can contribute to their potential degradation and wear over time. OBJECTIVES: Our aim was to investigate the wear of lead insulation following the removal of transvenous leads and pinpoint the regions of the lead most vulnerable to damage. MATERIAL AND METHODS: We undertook a prospective analysis of patients from a single tertiary center who underwent transvenous lead explantation (TLE) between October 1, 2013, and July 31, 2015. Specifically, our examination focused on endocardial leads removed using simple screw-out and gentle traction techniques. Subsequent lead evaluations were conducted utilizing scanning electron and optical microscopes. RESULTS: Among the 86 patients who underwent the TLE procedure, 26 patients (30%) required the removal of 39 leads through simple traction. Inspection using scanning electron microscopy consistently indicated insulation damage across all leads. A total of 347 damaged sites were identified: 261 without lead unsealing and 86 exhibiting unsealing. Notably, the sections of the leads located within the intra-pocket area demonstrated the highest vulnerability to damage (odds ratio (OR): = 9.112, 95% confidence interval (95% CI): 3.326-24.960), whereas the intravenous regions displayed the lowest susceptibility (OR: 0.323, 95% CI: 0.151-0.694). CONCLUSIONS: Our study reveals that all evaluated leads exhibited insulation damage, with the intra-pocket segments manifesting a notably higher prevalence of damage than the intravenous segments.

Indications for transvenous lead extraction and its procedural and early outcomes in elderly patients: a single-center experience.

INTRODUCTION: Due to the prolonged survival of patients with cardiovascular implantable electronic devices, leads often need to be removed in elderly individuals. OBJECTIVES: We aimed to analyze indications for transvenous lead extraction (TLE), procedure effectiveness and safety, as well as 30­day follow­up in younger patients (≤80 years) and octogenarians (>80 years). PATIENTS AND METHODS: This prospective study included 667 patients who underwent TLE: 90 octogenarians (13.5%) at a mean age of 83.8 (range, 80.4-93) years and 577 younger patients (86.5%) at a mean age of 64.2 (range, 18.9-79.9) years. RESULTS: Octogenarians had a greater number of comorbidities, fewer implantable cardioverter­defibrillators implanted, and more frequently had infection as an indication for TLE, as compared with younger patients (33.3% vs 17.1%; P <0.001). In octogenarians, 138 leads were extracted, as compared with 894 leads in younger patients. Octogenarians and younger patients had similar rates of complete lead removal (98.6% and 97.1%, respectively; P = 0.48), total procedural success (97.8% and 96%, respectively; P = 0.7), major complications (0% and 1.6%, respectively; P = 0.45), and minor complications (2.2% and 1.6%, respectively; P = 0.45). There was 1 death associated with TLE in younger patients. Non-procedure­related deaths within 30 days after TLE were more frequent in octogenarians than in younger patients (5.6% vs 1.9%; P = 0.04). CONCLUSION: We showed that TLE in patients older than 80 years seems to be as effective as in younger patients; however, it is associated with significantly higher non-procedure­related 30­day mortality.

Inflammatory markers in the diagnostic workup of pacemaker- and defibrillator­related infections in patients referred for transvenous lead extraction.

BACKGROUND: Infectious complications can be life­threatening in patients with permanent transvenous pacemakers and their diagnosis can be challenging. AIMS: The aim of the study was to assess the diagnostic utility of white blood cell (WBC) count and C­reactive protein (CRP) concentrations in infectious complications in patients with cardiac pacemakers. METHODS: The prospective study included patients who underwent transvenous lead extraction (TLE) due to various indications. The diagnosis of lead­dependent infective endocarditis (LDIE) was based on the modified Duke criteria, and the diagnosis of local infection was based on symptoms related to device pocket. The study population consisted of 640 patients: 63 (9.9%) with LDIE, 61 (9.5%) with local infection, and 516 controls (80.6%) referred for TLE due to noninfectious indications. We evaluated WBC count and CRP concentrations in each group of patients and assessed the predictive value of these tests for the diagnosis of LDIE and local infection. RESULTS: Patients with local infection did not differ in terms of median WBC and CRP values compared with controls (P = 0.99 and P = 0.13, respectively), whereas patients with LDIE had higher median WBC count and CRP level (P <0.001 and P <0.001, respectively). In the LDIE group, WBC diagnostic test showed 46.0% sensitivity, 95.3% specificity, 90.5% accuracy, 51.8% positive predictive value, and 94.2% negative predictive value. The diagnostic test based on CRP levels showed 84.1% sensitivity, 81.8% specificity, 82.0% accuracy, 33.5% positive predictive value, and 97.9% negative predictive value. CONCLUSIONS: In patients undergoing TLE due to infectious indications, inflammatory markers (WBC count, CRP level) were within normal range in the local­infection group and markedly elevated in the LDIE group. Inflammatory markers were useful to determine the extent of the infection in patients with local infection.

Effectiveness and safety of transvenous extraction of single- versus dual-coil implantable cardioverter-defibrillator leads at single-center experience.

The available literature lacks data concerning direct comparison of the effectiveness and safety of single- versus dual-coil implantable cardioverter-defibrillator (ICD) leads transvenous extraction. Certainly, additional shocking coil in superior vena cava adds to the amount of metal in the vascular system. Adhesions developing around the superior vena cava coil add to the difficulty of extraction of ICD lead if lead removal is required. The aim of the study was to assess the effectiveness and safety of single- and dual-coil ICD leads transvenous extraction using mechanical systems. We performed transvenous lead extraction (TLE) of 197 ICD leads in 196 patients. There were 46 (23.3%) dual-coil leads removed from 46 (23.5%) patients. Cardiovascular implantable electronic device-related infection was an indication for TLE in 25.0% of patients. The following extracting techniques were used: manual direct traction, mechanical telescopic sheaths, controlled-rotation mechanical sheaths, and femoral approach. Complete ICD lead removal and complete procedural success in both groups were similar (99.3% in single-coil vs 97.8% in dual-coil, P = .41 and 99.3% in single-coil vs 97.8% in dual-coil, P = 0.41, respectively). We did not find significant difference between major and minor complication rates in both groups (2.0% in single-coil vs 4.3% in dual-coil, and 0.7% in single-coil vs 0.0% in dual-coil, P = .58, respectively). There was 1 death associated with the TLE procedure of single-coil lead.This study shows that extraction of dual-coil leads seems to be comparably safe and effective to extraction of single-coil leads. On the other hand, it requires longer fluoroscopy time and frequent utilization of advanced tools.

Permanent atrial fibrillation in patients with a dual­chamber pacemaker.

BACKGROUND: Atrial fibrillation (AF) is thought to be a progressive arrhythmia. The impact of sex and position of right ventricular lead is not well recognized. Whilst nonparoxysmal AF compared with paroxysmal AF has been associated with increased mortality in the general population, its prognostic significance nin patients with a dual­chamber (DDD) pacemaker is less clear. AIMS: The aim of the study was to determine the incidence of permanent AF in patients with a DDD pacemaker, analyze the effect of selected baseline characteristics on permanent AF development, and examine the impact of permanent AF on patient survival. METHODS: A retrospective cohort study included 3932 consecutive patients who underwent DDD pacing system implantation between 1984 and 2014. Follow­up was completed in August 2016. We included 3771 patients (96%) with post­operative follow­up and known vital status. Occurrence of permanent AF and all­cause mortality were the study endpoints. RESULTS: During mean follow­up of 6.5 years, permanent AF occurred in 717 patients (19%). Sex (hazard ratio [HR], 1.316; 95% CI, 1.134-1.528, for men), age at implant (HR, 1.041; 95% CI, 1.033-1.049, 1-year increase), history of AF (HR, 3.521; 95% CI, 3.002-4.128) were independently associated with permanent AF development, whereas position of right ventricular lead (apical versus nonapical) and primary pacing indication (atrioventricular block versus sick sinus syndrome) were not related to permanent AF. Permanent AF was a significant risk factor for increased mortality (age- and sex­adjusted HR, 1.475; 95% CI, 1.294-1.682). CONCLUSIONS: Permanent AF occurrence was independently predicted by advanced age at implant, male sex, and preexisting AF and associated with worse survival.

Association of selected factors with long-term prognosis and mortality after dual-chamber pacemaker implant.

BACKGROUND: Dual-chamber (DDD) pacing is the most widely utilised pacing modality in many parts of the world. The present study aimed to evaluate life expectancy of DDD pacemaker patients in comparison to the age- and sex-matched general population, assess changes in baseline characteristics over three decades of the inclusion period and determine the association between selected variables and patient survival. METHODS: This longitudinal study of consecutive de novo DDD pacemaker implantations performed between 1984 and 2014, with all-cause mortality until 2016 as the endpoint, was conducted at a singlecenter university hospital. RESULTS: Under assessment were 3928 patients with a total of 30,087 patient-years of survival time. Compared to the general population, the observed survival was significantly inferior until 12 years post DDD pacemaker implant (HR = 1.499, p < 0.001), whereas after 12 years of follow-up the observed survival was significantly superior (HR = 0.555, p < 0.001). A comparison of patient baseline characteristics over three decades revealed the following significant changes: more elderly patients, more female patients, less patients with atrioventricular block, more patients with atrial fibrillation/atrial flutter (AF/AFL) and fewer patients with an apical right ventricular (RV) lead position in the later decades. In multivariate analysis male sex and higher age were the only variables significantly associated with shorter survival time. Indication for pacing, history of pre-implant AF/AFL, RV lead position and device infection were not associated with survival. CONCLUSIONS: In the very-long-term follow-up of DDD pacemaker patients, the parameters associated with survival were sex and baseline age at first implantation.

The usefulness of SPECT-CT with radioisotope-labeled leukocytes in diagnosing lead-dependent infective endocarditis.

BACKGROUND: Lead-dependent infective endocarditis (LDIE) is a life-threatening complication of permanent transvenous cardiac pacing. According to the 2015 European Society of Cardiology (ECS) guidelines, the diagnosis of LDIE is based on the modified Duke criteria (MDC), while single-photon emission computed tomography with conventional computed tomography (SPECT-CT) with radioisotope-labeled leukocytes serves as an additional tool in difficult cases. The major challenge is to differentiate between true vegetation and a thrombus. OBJECTIVES: The aim of the study was to evaluate the usefulness of SPECT-CT with radioisotope-labeled leukocytes in diagnosing LDIE in patients with intracardiac masses (ICMs). MATERIAL AND METHODS: The prospective registry included 40 consecutive patients admitted with an ICM on the lead and suspicion of LDIE. The confirmation or rejection of the LDIE diagnosis was made according to an algorithm based on the MDC. The cohort was divided into 2 groups: patients with definite and possible LDIE diagnoses based on the MDC (the LDIE-positive group), and patients with negative LDIE diagnoses according to the MDC (the LDIE-negative group). All patients underwent SPECT-CT with radioisotope-labeled leukocytes. The diagnostic ability of SPECT-CT was compared to the gold standard MDC. RESULTS: The LDIE-positive group with diagnosis based on the MDC consisted of 19 patients (LDIE definite - 11; LDIE possible - 8). The LDIE diagnosis was rejected on the basis of the MDC in 21 patients. The SPECT-CT results were compared with the MDC results and showed 73.7% sensitivity, 81.0% specificity, 77.5% accuracy, 77.8% positive predictive value (PPV), 77.3% negative predictive value (NPV), likelihood ratio positive (LR+) 3.868, likelihood ratio negative (LR-) 0.325, and moderate agreement (κ = 0.548, p < 0.001). After the exclusion of 5 patients treated with antibiotics at the time of the SPECT-CT, LR+ and LRimproved to 5.250 and 0, respectively, and inter-test agreement amounted to almost perfect concordance (κ = 0.773, p < 0.001). CONCLUSIONS: Single-photon emission computed tomography with conventional CT with radioisotopelabeled leukocytes is a useful, efficient, single-step test for diagnosing LDIE.

Years of life lost as a measure of premature death among dual­chamber pacemaker recipients from Malopolska Province.

BACKGROUND: Pacemakers have become the standard of care in patients with severe bradycardia and conduction abnormalities. The survival and premature mortality can be assessed using the years of life lost (YLLs). AIMS: The aim of the study was to analyze mortality trends over the period from 1999 to 2015 among patients implanted with a dual­chamber (DDD) pacemaker who were inhabitants of Malopolska Province. METHODS: This was a retrospective study of records collected from consecutive patients who underwent de novo DDD pacemaker implantation at a single center between 1984 and 2014. Inclusion criteria were residence status in Malopolska Province at the latest follow­up visit and death between 1999 and 2015. The standard expected years of life lost per death was used to calculate YLLs. Time trends were evaluated with joinpoint models and presented as an average annual percentage change (AAPC). RESULTS: Among a total of 3932 consecutive patients implanted with a DDD pacemaker, 1211 patients met the inclusion criteria. We noted an increase in the mean age at implant from 70 years in 1999 to 75.5 years in 2015 (AAPC, 0.6%; P <0.05), the number of years lived after DDD pacemaker implantation from 2.6 years to 8.2 years (AAPC, 7.4%; P <0.05), and the mean age at death from 72.6 years to 83.8 years (AAPC, 0.89%; P <0.05). Finally, we observed a reduction of the YLLs per death from 17.4 years in 1999 to 9 years in 2015 (AAPC, -4%; P <0.05). All trends were significant for both men and women. CONCLUSIONS: In the 17­year follow­up, we showed significant changes in analyzed trends, in particular a reduction in the YLLs per death.

Lead-related complications after DDD pacemaker implantation.

BACKGROUND: Pacing leads remain the weakest link in pacemaker systems despite advances in manufacturing technology. AIM: The aim of the study was to assess the long-term pacing lead performance in an unselected real-life cohort following primary DDD pacing system implantation. METHODS: A single-centre retrospective analysis of patients who underwent DDD pacing system implantation between October 1984 and December 2014 and were followed-up until August 2016 was conducted. The inclusion criterion was at least one follow-up visit after post-implant discharge. The performance of each atrial and ventricular lead implanted was evaluated during the follow-up period, and the incidence of, and predictive factors for, lead dislodgement and failure were analysed. RESULTS: The data of 3771 patients and 24,431.8 patient-years of follow-up were analysed. The mean follow-up of patients was 77.7 ± 61.8 months. During the study period, 7887 transvenous atrial and right ventricular pacing leads were implanted. Lead dislodgement occurred in 94 (1.2%) leads (92 [2.4%] patients), perforation in 11 (0.1%) leads (10 [0.3%] patients), and lead failure in 329 (4.2%) leads (275 [7.3%] patients). Atrial lead position was a predictive factor for lead dislodgement, while age at implantation, polyurethane 80A insulation, subclavian vein access, unipolar lead construction, and lead manufacturer were multivariate predictors of lead failure. CONCLUSIONS: Leads with polyurethane 80A insulation, unipolar construction, and those implanted via subclavian vein puncture exhibited the worst long-term performance.

Long-term follow-up of DDD pacing mode.

BACKGROUND AND AIM: The aim of this study was to determine the long-term survival of DDD pacing and identify the main reasons for its loss. METHODS: The study group consisted of 496 patients in whom a DDD pacing system was implanted between October 1984 and March 2002 and who were followed up until July 2010. The follow-up period was 152.1 ± 35.5 months. The patients' mean age at the time of implantation was 59.5 ± 12.5 years, and 53.5% were male; 58% had sick sinus syndrome (SSS), 26% had atrioventricular block (AVB), 15% had both of these indications simultaneously, and 1% had other indications. The incidence of lead malfunction, progression to chronic atrial fibrillation (AF), and the rate of infective complications was analysed. RESULTS: During the follow-up, 369 patients remained in DDD mode stimulation. DDD mode survival rate at one, five, ten and 15 years was, respectively, 96%, 86%, 77% and 72%. The most common reason for reprogramming out of DDD mode was the development of permanent AF in 65 (13.1%) patients. The occurrence of chronic AF was associated with a prior history of paroxysmal AF (p = 0.0001), SSS (p = 0.0215), and older age at time of implantation (p = 0.0068) compared to patients who remained in sinus rhythm. Lead malfunction caused loss of DDD mode pacing in 56 (11.3%) patients. Atrial leads were damaged in 37 patients, ventricular in 12 patients, and both leads in seven patients. The subclavian vein puncture was correlated with the mechanical damage of the atrial lead (p = 0.02935) compared to cephalic vein access. At the moment of complication, the patients with a dysfunctional lead were significantly younger than those who progressed to chronic AF(p = 0.0019). Infective complications which caused temporary loss of DDD pacing were observed in six patients: five had pocket infection and one had lead-dependent infective endocarditis. CONCLUSIONS: 1. Effective DDD pacing from the originally implanted system was noted in a high percentage (72%) of patients in long-term observation (15 years). 2. Progression to permanent AF is the most common reason for loss of DDD pacing;a history of paroxysmal AF and old age are the risk factors. 3. Subclavian vein puncture is associated with a higher rate of atrial lead damage.