Background: To ensure the safety and efficacy of the increasing number of transvenous lead extractions (TLEs), it is necessary to adequately assess the procedure-related risk. Methods: We analyzed potential clinical and procedural risk factors associated with 2049 TLE procedures. The TLEs were performed between 2006 and 2016 using only simple tools for lead extraction. Logistic regression analysis was used to develop a risk prediction scoring system for TLEs. Results: Multivariate analysis showed that the sum of lead dwell times, anemia, female gender, the number of procedures preceding TLE, and removal of leads implanted in patients under the age of 30 had a significant influence on the occurrence of major complications during a TLE. This information served as a basis for developing a predictive SAFeTY TLE score, where: S = sum of lead dwell times, A = anemia, Fe = female, T = treatment (previous procedures), Y = young patients, and TLE = transvenous lead extraction. In order to facilitate the use of the SAFeTY TLE Score, a simple calculator was constructed. Conclusion: The SAFeTY TLE score is easy to calculate and predicts the potential occurrence of procedure-related major complications. High-risk patients (scoring more than 10 on the SAFeTY TLE scale) must be treated at high-volume centers with surgical backup.

Background: Lead-dependent tricuspid dysfunction (LDTD) is one of important complications in patients with cardiac implantable electronic devices. However, this phenomenon is probably underestimated because of an improper interpretation of its clinical symptoms. The aim of this study was to identify LDTD mechanisms and management in patients referred for transvenous lead extraction (TLE) due to lead-dependent complications. Methods: Data of 940 patients undergoing TLE in a single center from 2009 to 2011 were assessed and 24 patients with LDTD were identifi ed. The general indications for TLE, pacing system types and lead dwell time in both study groups were comparatively analyzed. The radiological and clinical effi cacy of TLE procedure was also assessed in both groups with precision estimation of clinical status patients with LDTD (before and after TLE). Additionally, mechanisms, concomitant lead-dependent complications and degree (severity) of LDTD before and after the procedure were evaluated. Telephone follow-up of LDTD patients was performed at the mean time 1.5 years after TLE/replacement procedure. Results: The main indications for TLE in both groups were similar (apart from isolated LDTD in 45.83% patients from group I). Patients with LDTD had more complex pacing systems with more leads (2.04 in the LDTD group vs. 1.69 in the control group; p = 0.04). There were more unnecessary loops of lead in LDTD patients than in the control group (41.7% vs. 5.24%; p = 0.001). There were no signifi cant differences in average time from implantation to extraction and the number of preceding procedures. Signifi cant tricuspid regurgitation (TR-grade III–IV) was found in 96% of LDTD patients, whereas stenosis with regurgitation in 4%. The 10% frequency of severe TR (not lead dependent) in the control group patients was observed. The main mechanism of LDTD was abnormal leafl et coaptation caused by: loop of the lead (42%), septal leafl et pulled toward the interventricular septum (37%) or too intensive lead impingement of the leafl ets (21%). LDTD patients were treated with TLE and reimplantation of the lead to the right ventricle (87.5%) or to the cardiac vein (4.2%), or surgery procedure with epicardial lead placement following ineffective TLE (8.3%). The radiological and clinical effi cacy of TLE procedure was very high and comparable between the groups I and II (91.7% vs. 94.2%; p = 0.6 and 100% vs. 98.4%; p = 0.46, respectively). Repeated echocardiography showed reduced severity of tricuspid valve dysfunction in 62.5% of LDTD patients. The follow- -up interview confi rmed clinical improvement in 75% of patients (further improvement after cardiosurgery in 2 patients was observed). Conclusions: LDTD is a diagnostic and therapeutic challenge. The main reason for LDTD was abnormal leafl et coaptation caused by lead loop presence, or propping, or impingement the leafl ets by the lead. Probably, TLE with lead reimplantation is a safe and effective option in LDTD management. An alternative option is TLE with omitted tricuspid valve reimplantation. Cardiac surgery with epicardial lead placement should be reserved for patients with ineffective previous procedures. Background: Lead-dependent tricuspid dysfunction (LDTD) is one of important complications in patients with cardiac implantable electronic devices. However, this phenomenon is probably underestimated because of an improper interpretation of its clinical symptoms. The aim of this study was to identify LDTD mechanisms and management in patients referred for transvenous lead extraction (TLE) due to lead-dependent complications. Methods: Data of 940 patients undergoing TLE in a single center from 2009 to 2011 were assessed and 24 patients with LDTD were identifi ed. The general indications for TLE, pacing system types and lead dwell time in both study groups were comparatively analyzed. The radiological and clinical effi cacy of TLE procedure was also assessed in both groups with precision estimation of clinical status patients with LDTD (before and after TLE). Additionally, mechanisms, concomitant lead-dependent complications and degree (severity) of LDTD before and after the procedure were evaluated. Telephone follow-up of LDTD patients was performed at the mean time 1.5 years after TLE/replacement procedure. Results: The main indications for TLE in both groups were similar (apart from isolated LDTD in 45.83% patients from group I). Patients with LDTD had more complex pacing systems with more leads (2.04 in the LDTD group vs. 1.69 in the control group; p = 0.04). There were more unnecessary loops of lead in LDTD patients than in the control group (41.7% vs. 5.24%; p = 0.001). There were no signifi cant differences in average time from implantation to extraction and the number of preceding procedures. Signifi cant tricuspid regurgitation (TR-grade III–IV) was found in 96% of LDTD patients, whereas stenosis with regurgitation in 4%. The 10% frequency of severe TR (not lead dependent) in the control group patients was observed. The main mechanism of LDTD was abnormal leafl et coaptation caused by: loop of the lead (42%), septal leafl et pulled toward the interventricular septum (37%) or too intensive lead impingement of the leafl ets (21%). LDTD patients were treated with TLE and reimplantation of the lead to the right ventricle (87.5%) or to the cardiac vein (4.2%), or surgery procedure with epicardial lead placement following ineffective TLE (8.3%). The radiological and clinical effi cacy of TLE procedure was very high and comparable between the groups I and II (91.7% vs. 94.2%; p = 0.6 and 100% vs. 98.4%; p = 0.46, respectively). Repeated echocardiography showed reduced severity of tricuspid valve dysfunction in 62.5% of LDTD patients. The follow- -up interview confi rmed clinical improvement in 75% of patients (further improvement after cardiosurgery in 2 patients was observed). Conclusions: LDTD is a diagnostic and therapeutic challenge. The main reason for LDTD was abnormal leafl et coaptation caused by lead loop presence, or propping, or impingement the leafl ets by the lead. Probably, TLE with lead reimplantation is a safe and effective option in LDTD management. An alternative option is TLE with omitted tricuspid valve reimplantation. Cardiac surgery with epicardial lead placement should be reserved for patients with ineffective previous procedures.

Aims To analyse the effectiveness, safety and long-term outcomes of conventional non-powered mechanical systems for transvenous lead extraction (TLE) performed by experienced first operators. Outcomes were assessed according to lead location and type of operating room in which the procedure was performed. Methods and results Data from 2049 patients (mean age: 65 years), with infectious (40%) or non-infectious (60%) indications, were analysed over a mean of 3.37 (+/- 2.29) years. A total of 3426 leads were extracted; and, overall, 95% full procedural, 4% partial procedural, and 98% clinical success were demonstrated. Within the patient cohort, 1.8% (37/2049) experienced major complications, with cardiac tamponade being predominant (30/37). Cardiac tamponade was identified as the main cause of mortality, as well as the cause of all procedure-related deaths (6/2049; 0.3%). Cardiac tamponade occurred in 1.8% of atrial and 0.3% of right ventricular lead extractions, with fatal tamponade reported in 9% of atrial, 40% of ventricular, and 67% of coronary sinus lead extractions. No association between lead location and cardiac tamponade-related mortality was observed; however, lead location did affect the success of pericardiocentesis. The cardiac tamponade-related mortality rate was 37% when TLE was performed in an electrophysiology laboratory. No deaths were reported when the procedure was performed in a cardiac surgery or hybrid operating room. Long-term survival was improved when TLE was performed due to non-infectious indications, rather than pocket infection or lead-related endocarditis (P<0.001). Conclusion Using conventional non-powered mechanical sheaths, TLE was effective even in patients at high risk of complications.

Objective. Transvenous lead extraction (TLE) is the gold standard in the management of patients with cardiac implantable electronic devices (CIED)-related complications. Knowledge of TLE risk factors is very important.Methods. Clinical data from 1915 patients undergoing TLE at the Reference Center between 2006 and 2015 were analyzed. The effects of clinical and procedure-related factors on the development of major (MJC) and minor (MIC) complications and survival after TLE were evaluated.Results. MJC were caused mainly by lead implant duration, presence of abandoned leads, multiple procedures preceding TLE, and any technical problem during TLE. Of clinical factors female gender and anemia increased the risk of MJC. MIC were reported in patients with the first implantation of CIED under the age of 30 and after sternotomy analysis of 30-day survival after procedure demonstrated a significant effect of clinical factors and lead dwell times, previous unsuccessful TLE, and MIC.Conclusions. Efficacy and safety of TLE depend mainly on procedure-related factors. This knowledge is essential for preventing MJC and MIC. Mortality at 30 days following TLE is mainly associated with the clinical factors; however, there was also a significant effect of lead dwell time and periprocedural complications on the short-term prognosis of patients undergoing TLE.

Background: Damage to the tricuspid valve (TVD) is now considered either a major or minor complication of the transvenous lead extraction procedure (TLE). As yet, the risk factors and long-term survival after TLE in patients with TVD have not been analyzed in detail. Methods: This post hoc analysis used clinical data of 2631 patients (mean age 66.86 years, 39.64% females) who underwent TLE procedures performed in three high-volume centers. The risk factors and long-term survival of patients with worsening tricuspid valve (TV) function after TLE were analyzed. Results: In most procedures (90.31%), TLE had no negative influence on TV function, but in 9.69% of patients, a worsening of tricuspid regurgitation (TR) to varying degrees was noted, including significant dysfunction in 2.54% of patients. Risk factors of TLE relating to severe TVD were: TLE of pacing leads (5.264; p = 0.029), dwell time of the oldest extracted lead (OR = 1.076; p = 0.032), strong connective scar tissue connecting a lead with tricuspid apparatus (OR = 5.720; p < 0.001), and strong connective scar tissue connecting a lead with the right ventricle wall (OR = 8.312; p < 0.001). Long-term survival (1650 ± 1201 [1–5519] days) of patients with severe TR was comparable to patients without tricuspid damage related to TLE. Conclusions: Severe tricuspid valve damage related to TLE is relatively rare (2.5%). The main risk factors for the worsening of TV function are associated with a longer lead dwell time (more often the pacing lead), causing stronger connective tissue scars connecting the lead to the tricuspid apparatus and right ventricle. TVD is unlikely to affect long-term survival after TLE.