scholarly journals Comparison of efficacy of different endovascular lead extraction techniques

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
F Bracke ◽  
N Verberkmoes ◽  
N Rademakers ◽  
M Van 't Veer ◽  
B.M Van Gelder

Abstract Background Reports on lead extraction often concern a single technique, rendering direct comparison between techniques difficult. Purpose We compared efficacy and complications of consecutively used endovascular extraction techniques in a single centre. Methods Single centre observational study of consecutive lead extractions from 1997 to 2019. The preferential technique used over time was at first a laser sheath (LS), subsequently a femoral approach (FA) if feasible, and finally rotational mechanical sheaths (RMT). The FA remained the preferential initial technique for atrial and coronary sinus leads during the latter period. Extraction results are reported per lead for the initial technique before any alternative approach was initiated. Results A total of 1725 leads (including 222 ICD) leads were extracted in 775 patients. Primary endovascular extraction was attempted in 1703 leads (median implant time 6.0 yrs. [IQR 2.7–10.2]) with the remainder being surgically removed. Traction sufficed to remove 588 leads (median implant time 2.4 yrs. [IQR 1.2 - 4.7]). The table shows the radiological and procedural success of the initially used technique per lead. Including use as backup technique there were 7.4%, 0.5% and 1.2% major complications with respectively LS, FA, and RMT. Including backup approaches, clinical success (lead completely removed or only lead fragment <4cm left behind without mayor complication) for endovascular extraction of the 1703 leads was 94.8%. Conclusion The laser sheath has an inferior procedural outcome compared to rotational mechanical sheaths or a femoral approach which is largely the results of a higher complication rate. The femoral approach and mechanical rotational sheaths are seemingly equally effective, but the femoral approach is not suitable for many ICD leads and technically more demanding for ventricular leads. In current practice, the combination of a femoral approach and rotational mechanical sheaths yields optimal results. Funding Acknowledgement Type of funding source: None

EP Europace ◽  
2020 ◽  
Vol 22 (Supplement_1) ◽  
Author(s):  
A Polewczyk ◽  
W Jachec ◽  
L Segreti ◽  
M G Bongiorni ◽  
A Kutarski

Abstract Background Reduced left ventricle ejection fraction (LVEF) is a common risk factor of complications in patients undergoing different procedures. Aim of study The aim of the study was to assess  efficiency and safety of transvenous lead extraction (TLE) procedures in patients with reduced LVEF (< 40%) compared to patients with mid-range reduced and preserved LVEF (≥40%). Study group Data from 3434 of TLE procedures (patient"s age during TLE-65,5 ± 15,5 years, female; 1168 (34,01%), performed in two high volume European Centers (PISA – Italy, Lublin-Zamość – Poland) were analysed. Results In group with reduced LVEF (A) compared to the group of patients with LVEF ≥ 40% (B) the smaller number of female was found (p < 0,001). The number of devices with ICD leads was higher in group A (p < 0,001). Dwelling time for oldest lead and the oldest extracted lead were longer in group B (p < 0.001).  There were no differences in indications for TLE between presented groups. The procedure duration time was similar in both groups. There were no statistically significant differences in complete procedural success, clinical success, major and minor complications and procedure related death occurrence. Complete results are presented in  Table.1 Conclusion The effectiveness and safety of TLE in patients with reduced left ventricle ejection fraction does not differ from the results of the TLE procedures in patients with mid-range reduced and preserved LVEF. Abstract Table


2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
L Tulecki ◽  
M Czajkowski ◽  
S Targonska ◽  
K Tomkow ◽  
D Nowosielecka ◽  
...  

Abstract Background The guidelines suggest close co-operation between TLE operating team and cardiac surgery and its key role in the management of life-threatening complications remains unquestionable. But the role of cardiac surgeon seems to be much more extended. Purpose We have analysed the role of cardiac surgery in treatment of patients undergoing TLE procedures. Methods Using standard non-powered mechanical systems we have extracted ingrown PM/ICD leads from 3207 pts (38,7% female, average age 65,7-y) during the last 14 years. Non-infectious TLE indications were in 66,4% of patients. 46% had PM DDD system, 19% PM SSI, 22% ICD, 9% CRT, 4% other systems. In 12% of patients abandoned leads were found. 8% of patients had one lead, 54% - two, 15% - three and 4% - 4–6 leads in the heart. An average dwell time of all leads was 91,5 mth. The lead entry side was left in 96% of patients, right in 3% and both – 4%. Results Procedural success 96,1%, clinical success - 97,8%, procedure-related death 0,2%. Major complications appeared in 1,9% (cardiac tamponade 1,2%, haemothorax 0,2%, tricuspid valve damage 0,3%, stroke, pulmonary embolism <1%). Conclusions Rescue cardiac surgery (for severe haemorrhagic complications) is still the most frequent reason of surgical intervention (1,1%). The second area of co-operation includes supplementary cardiac surgery after (incomplete) TLE (0,8%). The third one is connected with reconstruction or replacement of tricuspid valve, which can be affected by ingrown lead or damaged during TLE procedure (0,5%). Implantation of the complete epicardial system during any surgical intervention (rescue or delayed) should be considered as a supplementation of the operation (0,65%). Some of patients after TLE need implantation of epicardial leads for permanent epicardial pacing (0,6%) and some only left ventricular lead to rebuild permanent cardiac resynchronisation (0,5%). The single experience of large TLE centre indicates the necessity of close co-operation with cardiac surgeon, whose role seems to be more comprehensive than a surgical stand-by itself. Table 1 Funding Acknowledgement Type of funding source: None


Circulation ◽  
2015 ◽  
Vol 132 (suppl_3) ◽  
Author(s):  
Eric W Black-Maier ◽  
Sean D Pokorney ◽  
Robert K Lewis ◽  
Alexander Christian ◽  
Ruth A Greenfield ◽  
...  

Introduction: Percutaneous transvenous lead extraction of cardiovascular implantable electronic devices (CIEDs) is increasingly common. Although ICD leads are widely considered to be more difficult to extract than pacemaker leads, there are few direct comparisons. Methods/Results: Using a cohort of 368 consecutive patients undergoing lead extraction (dwell time >1 year) between 2005-2012, we compared baseline characteristics/outcomes in extractions involving pacing versus ICD leads. We defined major adverse events (MAE) as any events/complications that required procedural intervention, transfusion, or that resulted in death or serious harm during index hospitalization. Median age was 60.6 yrs and 29.6% were women. There were 136 (37%) pacing lead extractions and 232 (63%) ICD lead extractions. Pacing leads had a longer dwell time (6.14 yrs [IQR 1.2-10.9 ] versus 4.4 yrs [IQR 1.1-6.4], p<0.001) and higher median LVEF (55% [IQR 35-55] vs. 30% [IQR 20-40], p<0.001) compared with ICD lead patients. Indications for pacing and ICD lead extractions included sepsis/endocarditis (21.3% vs. 24.6%, p=0.48), pocket infection (40.4% vs. 34.9%, p=0.29), and lead failure (15.4% vs. 38.8%, p<0.001). There were no significant differences between pacing and ICD lead extractions in median fluoroscopy time (5.5 vs. 8.5 minutes, p=0.86) or femoral bailout rate (4.4% vs. 5.2%, p=0.73). There were similar rates of all-cause MAE during index hospitalization (5.1% vs. 5.6%), death (2.2% vs 3.2%) and clinical success (97.0% vs. 97.0%, p=0.55) in pacemaker and ICD extractions, respectively. Conclusions: ICD leads are more commonly extracted relative to pacemaker leads, and this difference is driven by larger numbers of lead failure within ICD leads. Despite much longer dwell times, major adverse events were similar in pacing lead cases compared with ICD extractions.


EP Europace ◽  
2021 ◽  
Vol 23 (Supplement_3) ◽  
Author(s):  
T Madej ◽  
K Matschke ◽  
M Knaut

Abstract Funding Acknowledgements Type of funding sources: None. Background Extraction of cardiac implantable electronic device (CIED) leads using excimer laser is in use since &gt; 20 years, but the predictors of success, all-cause complications and mortality are not yet sufficiently statistically evaluated.  Method All consecutive laser extractions performed at our institution between September 2011 and March 2020 with lead age &gt; 12 months were included and retrospectively analysed. Results 792 leads (mean age 75 months) were extracted during 335 procedures. The indication for extraction was pocket infection in 59%, CIED endocarditis in 25%, lead dysfunction or upgrade in 14% and others in 2%. 94.6% of leads were extracted complete, 4.2% partial (&lt; 4 cm rest) and the extraction failed in 1.3% of the leads (retention of ≥ 4 cm rest). Multivariable analysis identified lead age &gt; 7.5 years (odds ratio [OR] 6.5; p = 0.0281), broken leads (OR 28.0; p = 0.0009) and implantable cardioverter-defibrillator (ICD) leads (OR 6.5; p = 0.0010) as independent predictors of failed extraction. CIED-endocarditis was independently associated with complete extraction (OR 3.3; p = 0.0218). Complete procedural success or clinical success was achieved in 330 of 335 procedures (98.6%). The lead extraction failed in five cases (1.5%). Major procedure-associated adverse events (injuries of the great vessels or heart) occurred in four cases (1.2%). Two patients died perioperatively (0.6%). Minor complications occurred in 13 cases (3.9%). Major adverse events (MAE) causally not related to the procedure occurred in 18 (5.4%) of the patients. The most frequent MAE was postoperative aggravation of the sepsis (10 patients; 3.0%).  Independent predictors of major adverse events were CIED-endocarditis (OR 6.0; p = 0.0175), preoperative C-reactive-protein (CRP) &gt; 35 mg/l (OR 3.8; p = 0.0412) and body mass index (BMI) ≥ 25 kg/m2 (OR 5.0; p = 0.0489). Ten patients (3%) died during the hospital stay.  CIED-endocarditis with preoperative CRP &gt; 35 mg/l was independently associated with hospital mortality in multivariable analysis (OR 10.7; p = 0.0020). The Kaplan-Meyer analysis of 30-day mortality showed a significantly worse survival of patients with endocarditis (Log-Rank p = 0.0102). Conclusion Leads &gt; 7.5 years, broken leads and ICD leads are independent predictors of failed extraction. CIED endocarditis, CRP &gt; 35 and BMI ≥ 25 are associated with MAE. CIED endocarditis is related to higher short-term mortality despite successful lead extraction. Abstract Figure. Predictors of major adverse events


2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
M Giannotti Santoro ◽  
L Segreti ◽  
F Fiorentini ◽  
G Bernini ◽  
V Barletta ◽  
...  

Abstract Introduction Transvenous lead extraction is a safe and effective procedure. The dwell time of the leads, with other factors, is associated with poor outcome of the procedure. However, a precise estimation of the success of the procedure is not available. Purpose The aim of this study is to identify a lead's age threshold able to predict the success of the transvenous lead extraction (TLE) procedure. Methods All patients who underwent TLE in our center from January 2009 to December 2017 were retrospectively analyzed. The primary endpoint was the clinical success of the procedure. The optimal cut-off threshold was determined by the analysis of Receiver-Operating Characteristics (ROC) curves, using the Youden index. Results We analyzed 1210 consecutive patients that required transvenous removal of 2343 leads (686 ICD leads, 1657 pacemaker leads, 322 coronary sinus leads). Clinical success was achieved in 1168 patients (96.5%). Dwelling time median of the oldest lead for a patient was 66 months (interquartile range 27.0–115.0). The oldest lead completely removed was 32 years old. ROC curve analysis showed a dwell time threshold of 107 months – 8,92 years - for clinical success (Positive Predictive Value: 99.5%; Negative Predictive Value: 7.8%) and the area under the curve (AUC) was 0.879. Comparison of ROC for dwelling time and the 0.5 curve was assessed as statistically significative (p<0.0001). Conclusions Transvenous lead extraction is an effective procedure. The best cut-off threshold to predict a very high clinical success is 107 months.


Author(s):  
F. A. Bracke ◽  
N. Rademakers ◽  
N. Verberkmoes ◽  
M. Van ’t Veer ◽  
B. M. van Gelder

Abstract Introduction Efficiency and safety are important features in the selection of lead extraction tools. We report our experience with different endovascular techniques to extract individual pacing and defibrillator leads. Methods This is a single-centre study of consecutive lead extraction procedures from 1997 until 2019. A total of 1725 leads were extracted in 775 patients. Direct traction sufficed for 588 leads, and 22 leads were primarily removed by surgery. The endovascular techniques used in the remainder were a laser sheath (190 leads), the femoral approach (717 leads) and rotating mechanical sheaths (208 leads). Results The three approaches were comparably effective in completely removing the leads (p = 0.088). However, there were more major complications with the laser sheath than with the femoral approach or rotating mechanical sheaths (8.4%, 0.5% and 1.2%, respectively). Therefore, the procedural result—extraction without major complications—was significantly better with both the femoral approach and rotating mechanical sheaths than with the laser sheath (p < 0.001). This result was confirmed after propensity score matching to compensate for differences between lead cohorts (p = 0.007). Cross-over to another endovascular tool was necessary in 7.9%, 7.1% and 8.2% of laser, femoral and rotating mechanical attempts, respectively. Conclusion All three endovascular lead extraction techniques showed comparable efficacy. However, there were significantly more major complications using the laser sheath compared to the femoral approach or rotating mechanical sheaths, leading us to abandon the laser technique. Importantly, no single endovascular technique sufficed to successfully extract all leads.


Author(s):  
Łukasz Tułecki ◽  
Anna Polewczyk ◽  
Wojciech Jacheć ◽  
Dorota Nowosielecka ◽  
Konrad Tomków ◽  
...  

Background: Transvenous lead extraction (TLE) is the preferred management strategy for complications related to cardiac implantable electronic devices. TLE sometimes can cause serious complications. Methods: Outcomes of TLE procedures using non-powered mechanical sheaths were analyzed in 1500 patients (mean age 68.11 years; 39.86% females) admitted to two high-volume centers. Results: Complete procedural success was achieved in 96.13% of patients; clinical success in 98.93%, no periprocedural death occurred. Mean lead dwell time in the study population was 112.1 months. Minor complications developed in 115 (7.65%), major complications in 33 (2.20%) patients. The most frequent minor complications were tricuspid valve damage (TVD) (3.20%) and pericardial effusion that did not necessitate immediate intervention (1.33%). The most common major complication was cardiac laceration/vascular tear (1.40%) followed by an increase in TVD by two or three grades to grade 4 (0.80%). Conclusions: Despite the long implant duration (112.1 months) satisfying results without procedure-related death can be obtained using mechanical tools. Lead remnants or severe tricuspid regurgitation was the principal cause of lack of clinical and procedural success. Worsening TR(Tricuspid regurgitation) (due to its long-term consequences), but not cardiac/vascular wall damage; is still the biggest TLE-related problem; when non-powered mechanical sheaths are used as first-line tools.


Author(s):  
Simon Pecha ◽  
Tibor Ziegelhoeffer ◽  
Yalin Yildirim ◽  
Yeong-Hoon Choi ◽  
Stephan Willems ◽  
...  

Abstract OBJECTIVES Transvenous lead extraction using mechanical rotational- or laser sheaths is an established procedure. Lead dwell time has been recognized as a risk factor for extraction failure and procedure-related complications. We therefore investigated the safety and efficacy of transvenous extraction of leads with an implant duration of more than 10 years. METHODS Between January 2013 and March 2017, a total of 403 patients underwent lead extraction in 2 high-volume lead extraction centres. One hundred and fifty-four patients with extraction of at least 1 lead aged over 10 years were included in this analysis. Laser lead extraction was the primary extraction method, with additional use of mechanical rotational sheaths or femoral snares, if necessary. All procedural- and patient-based data were collected into a database and retrospectively analysed. RESULTS Mean patient’s age was 65.8 ± 15.8 years, 68.2% were male. Three hundred and sixty-two leads had to be extracted. The mean lead dwell time of treated leads was 14.0 ± 6.1 years. Complete procedural success was achieved in 91.6% of cases, while clinical success was achieved in 96.8%. Failure of extraction occurred in 3.2%. Leads that could not be completely removed had a significantly longer lead dwell time (18.2 vs 13.2 years; P = 0.016). Additional mechanical rotational sheaths or femoral snares were used in 26 (16.9%) patients. Overall complication rate was 4.6%, including 5 (3.3%) major and 2 (1.3%) minor complications. There was no procedure-related mortality. CONCLUSIONS Transvenous lead extraction in leads aged over 10 years is safe and effective when performed in specialized centres and with use of multiple tools and techniques. Leads that could not be completely extracted had a statistically significant longer lead dwell time.


Author(s):  
Jus Ksela ◽  
Jan Prevolnik ◽  
Mark Racman

Abstract OBJECTIVES Extraction of cardiovascular implantable electronic devices in low-volume medical centres with limited clinical experience and an evolving lead extraction programme may be challenging. We aimed to evaluate the safety and efficacy of stepwise transvenous lead extraction (TLE) using a novel type of hand-powered rotational sheath as a first-line tool for extraction of chronically implanted devices in a single, low-volume centre. METHODS Sixty-seven consecutive patients undergoing a TLE procedure using the novel Evolution® RL rotational sheath as the first-line extraction tool between 2015 and 2019 at our institution were enrolled in the study. Their short-term and 30-day outcomes were observed. RESULTS Sixty-nine devices and 131 leads were explanted. Procedural and clinical success rates were 92.4% and 98.5%, respectively. Two procedures were classified as failures due to lead remnants &gt;4 cm remaining in patients’ vascular systems. One major (1.5%) and 3 minor (4.4%) adverse events and no deaths were observed. CONCLUSIONS TLE procedures, performed in a stepwise manner, using the Evolution RL sheath as a first-line extraction device and conducted by an experienced, surgically well-trained operator, offer excellent results with clinical and procedural success rates comparable to those, achieved in dedicated, high-volume institutions. Opting for optimal lead extraction approach in low-volume centres or institutions with evolving TLE programmes, a stepwise extraction strategy using the Evolution RL sheath by skilled operator may provide the optimal scheme with an excellent ratio between clinical and/or procedural success and complications.


2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
C T Starck ◽  
R H M Schaerf ◽  
A Breitenstein ◽  
J Steffel ◽  
S Najibi ◽  
...  

Abstract Background Patients with systemic CIED (Cardiac implantable electronic device) infection with large lead vegetations are a clinical challenge and carry a high operative risk. In three lead extraction centers a treatment strategy with minimal-invasive percutaneous aspiration of vegetations and subsequent transvenous lead extraction was established. The results of this concept were evaluated with regard to safety and efficacy in this retrospective multi-center study. Methods Between June 2015 and December 2018 we performed combined percutaneous aspiration procedures and transvenous lead extractions in 107 patients with 262 targeted leads (179 pacemaker leads, 83 ICD leads) for extraction. Mean lead vegetation size in preoperative echocardiography was 30.6±13.3 mm. Mean lead implant duration were 82.8 (1–254) months. The aspiration system is based on a veno-venous extracorporeal circuit with an in-line filter and a specialized venous drainage cannula. Results Complete procedural success of the percutaneous aspiration procedure was 94.4% (n=101), partial success was achieved in 4.7% (n=5). Three complications (2.8%) related to the aspiration procedure were encountered. In the concomitantly performed transvenous lead extraction procedures complete procedural success per targeted lead was 99.2% (n=260). 30 day mortality was 2.8% (n=3). Conclusion The minimal-invasive percutaneous aspiration procedure proved to be safe and effective. It facilitated the subsequent transvenous lead extraction procedure, avoids septic embolization into the pulmonary circulation and abolished the need for open surgical extraction in this high-risk patient group.


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