scholarly journals Results of the Patient-Related Outcomes of Mechanical lead Extraction Techniques (PROMET) study: a multicentre retrospective study on advanced mechanical lead extraction techniques

EP Europace ◽  
2020 ◽  
Vol 22 (7) ◽  
pp. 1103-1110 ◽  
Author(s):  
Christoph T Starck ◽  
Elkin Gonzalez ◽  
Omar Al-Razzo ◽  
Patrizio Mazzone ◽  
Peter-Paul Delnoy ◽  
...  
Keyword(s):  
Mortality Rate ◽  
Dwell Time ◽  
Clinical Success ◽  
Lead Extraction ◽  
Extraction Techniques ◽  
Mechanical Methods ◽  
Pacemaker Leads ◽  
Tools And Techniques ◽  
Passive Fixation ◽  
Related Mortality

Abstract Aims Several large studies have documented the outcome of transvenous lead extraction (TLE), focusing on laser and mechanical methods. To date there has been no large series addressing the results obtained with rotational lead extraction tools. This retrospective multicentre study was designed to investigate the outcomes of mechanical and rotational techniques. Methods and results Data were collected on a total of 2205 patients (age 66.0 ± 15.7 years) with 3849 leads targeted for extraction in six European lead extraction centres. The commonest indication was infection (46%). The targeted leads included 2879 pacemaker leads (74.8%), 949 implantable cardioverter-defibrillator leads (24.6%), and 21 leads for which details were unknown; 46.6% of leads were passive fixation leads. The median lead dwell time was 74 months [interquartile range (IQR) 41–112]. Clinical success was obtained in 97.0% of procedures, and complete extraction was achieved for 96.5% of leads. Major complications occurred in 22/2205 procedures (1%), with a peri-operative or procedure-related mortality rate of 4/2205 (0.18%). Minor complications occurred in 3.1% of procedures. A total of 1552 leads (in 992 patients) with a median dwell time of 106 months (IQR 66–145) were extracted using the Evolution rotational TLE tool. In this subgroup, complete success was obtained for 95.2% of leads with a procedural mortality rate of 0.4%. Conclusion Patient outcomes in the PROMET study compare favourably with other large TLE trials, underlining the capability of rotational TLE tools and techniques to match laser methods in efficacy and surpass them in safety.

scholarly journals Safety and efficacy of transvenous lead extraction of very old leads

2020 ◽  
Author(s):  
Simon Pecha ◽  
Tibor Ziegelhoeffer ◽  
Yalin Yildirim ◽  
Yeong-Hoon Choi ◽  
Stephan Willems ◽  
...  
Keyword(s):  
Dwell Time ◽  
Clinical Success ◽  
High Volume ◽  
Lead Extraction ◽  
Safety And Efficacy ◽  
The Mean ◽  
Procedural Success ◽  
Tools And Techniques ◽  
Related Mortality ◽  
Laser Lead Extraction

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.

Abstract 11945: Indications and Outcomes Following Transvenous Extraction of ICD versus Pacemaker Leads

Circulation ◽  
2015 ◽  
Vol 132 (suppl_3) ◽  
Author(s):  
Eric W Black-Maier ◽  
Sean D Pokorney ◽  
Robert K Lewis ◽  
Alexander Christian ◽  
Ruth A Greenfield ◽  
...  
Keyword(s):  
Adverse Events ◽  
Dwell Time ◽  
Clinical Success ◽  
Lead Extraction ◽  
Index Hospitalization ◽  
Lead Failure ◽  
Icd Leads ◽  
Pacemaker Leads ◽  
Pacing Lead ◽  
Major Adverse Events

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.

P3139Transvenous lead extraction: lead age threshold to predict the success of the procedure

2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
M Giannotti Santoro ◽  
L Segreti ◽  
F Fiorentini ◽  
G Bernini ◽  
V Barletta ◽  
...  
Keyword(s):  
Predictive Value ◽  
Dwell Time ◽  
Clinical Success ◽  
Effective Procedure ◽  
Lead Extraction ◽  
Youden Index ◽  
Operating Characteristics ◽  
Roc Curve Analysis ◽  
Dwelling Time ◽  
Icd Leads

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.

scholarly journals PROMET: The effect of operator profession on non-laser transvenous lead extraction

EP Europace ◽  
2021 ◽  
Vol 23 (Supplement_3) ◽  
Author(s):  
Z Akhtar ◽  
MM Gallagher ◽  
A Elbatran ◽  
CT Starck ◽  
L WM Leung ◽  
...  
Keyword(s):  
Regression Analysis ◽  
Multivariate Regression ◽  
Dwell Time ◽  
Clinical Success ◽  
Systemic Infection ◽  
High Volume ◽  
Multivariate Regression Analysis ◽  
High Rate ◽  
Lead Extraction ◽  
Cardiac Surgeons

Abstract Funding Acknowledgements Type of funding sources: None. OnBehalf PROMET group Background As implantation of cardiac implantable devices (CIED) rises globally, there is a paralleled need for extraction of these devices. Indications for transvenous lead extraction (TLE) is expanding, fuelling demand. This lifesaving procedure is performed by cardiologists and cardiac surgeons (CS). Cardiologists are familiar with transvenous methods whilst cardiac surgeons possess the skillset to address the significant complications associated with this procedure. We compared non-laser TLE outcomes performed by cardiologists and cardiac surgeons from six high-volume extraction centres across Europe. Methods Data was collected retrospectively from six major European TLE centres of 2205 patients and 3849 leads (PROMET). Propensity 1:1 score matching (PSM) was performed to account for confounding variables. PSM model with variables: lead dwell time, infection indication, biventricular system and defibrillator device, was best matched. This dataset was analysed to compare outcomes of TLE performed by the cardiologists and CS. Predictors of 30-day mortality and complications were identified using a multivariate regression analysis. Results Patients treated by CS and cardiologists were similar in age (64.7 vs 66.7 years, p = NS) and equally male (70.3% vs 72.3%, p = 0.39) with a parallel infectious indication (51.7% vs 47.6%, p = 0.1). Surgeons achieved a significantly higher proportion of clinical success than cardiologists (98.9% vs 96.4%, p = 0.001) and complete lead extraction (98% vs 95.9%, p &lt; 0.01) with a higher rate of minor complications (4.1% vs 2.2%, p = 0.024); major complications were similar (0.9% vs 1.2%, respectively, p = 0.46) as was 30-day mortality (3.2% vs 2%, respectively, p = 0.28). Multivariate regression analysis revealed systemic infection (p &lt; 0.001, OR 7.2 [CI 2.3-20.1]) and defibrillator system extraction (p = 0.025, OR 3.4 [CI 1.2-10.2]) increased the odds of 30-day mortality, whilst Evolution™ sheath use reduced the odds (p = 0.025, OR 0.34 [CI 0.13-0.88]); lead dwell time (p = 0.02, OR 1.005 [1-1.009] and Evolution™ sheath use (p = 0.023, OR 2.15[1.1-4.15]) increased the odds of complications. Conclusion Cardiac surgeons and cardiologists achieved a high rate of TLE procedural success and with a similar safety profile, replicating standards seen across Europe.

scholarly journals RENEDI: Results of the first observational and prospective registry of transvenous lead extraction in Argentina. Inter-societary Working Group.

2021 ◽  
Author(s):  
Javier Ferrari Ayarragaray ◽  
Ricardo Speranza ◽  
Hector Mazzetti ◽  
Alejandro Girela ◽  
Claudio De Zuloaga ◽  
...  
Keyword(s):  
Dwell Time ◽  
Major Complication ◽  
Cardiac Resynchronization ◽  
Lead Extraction ◽  
Primary Operator ◽  
Cardiac Resynchronization Therapy Devices ◽  
Pacemaker Leads ◽  
Low Incidence ◽  
Procedural Success ◽  
Practice Methods

Background and aim: RENEDI (“Registro Nacional de Extracción de Dispositivos”) is the first registry on Transvenous Lead Extraction (TLE) designed in Argentina with the objective of providing data on lead extraction real-world practice. Methods: An online database platform was designed. Data referred to patients, leads and extraction procedures were compiled and reviewed by a Committee. Results: A total of 621 leads were extracted from 325 patients (average age of 59 years; 71% male). The targeted leads included 374 pacemaker leads (61%), 176 implantable cardioverter-defibrillator leads (28%) and 71 cardiac resynchronization therapy devices (11%). Two hundred and thirty-three (38%) atrial, 367 (59%) ventricular and 21 (3%) coronary sinus leads placement. The average lead dwell time was 105. 9 months. The commonest indication for removal was infection (68%-Local 71%). Cardiovascular surgeons were usually the primary operator (81%). The presence of cardiovascular stand-by was reported in 72% of cases. Percutaneous approach (98%) was predominant. A total of 158 (25%) leads with a median dwell time of 33.3 months were extracted using simple traction. Overall complication rate was 4%. Only one major complication and no deaths were informed. Minor complications occurred in 3.6% of procedures. Complete procedural success was 96.2%. Incomplete extraction was obtained in 23 leads. No permanent disabling complications or procedure-related deaths were reported. Conclusions: Current Argentinian practice has demonstrated that TLE is a safe and effective procedure associated with a low incidence of complications and high success rate when it is performed in well-trained hands.

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
Keyword(s):  
Clinical Success ◽  
Lead Extraction ◽  
Extraction Techniques ◽  
Single Centre ◽  
Left Behind ◽  
Femoral Approach ◽  
Alternative Approach ◽  
Icd Leads ◽  
Procedural Success ◽  
Single Technique

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 &lt;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

The Evolution of Lead Extraction

2009 ◽  
Vol 5 (1) ◽  
pp. 32
Author(s):  
Melanie Maytin ◽  
Laurence M Epstein ◽  
◽  
Keyword(s):  
Natural Selection ◽  
Lead Extraction ◽  
Significant Morbidity ◽  
Extraction Techniques ◽  
Extraction Technology ◽  
Device Management ◽  
Future Developments ◽  
The Past ◽  
New Methods ◽  
Life Threatening

Prior to the introduction of successful intravascular countertraction techniques, options for lead extraction were limited and dedicated tools were non-existent. The significant morbidity and mortality associated with these early extraction techniques limited their application to life-threatening situations such as infection and sepsis. The past 30 years have witnessed significant advances in lead extraction technology, resulting in safer and more efficacious techniques and tools. This evolution occurred out of necessity, similar to the pressure of natural selection weeding out the ineffective and highly morbid techniques while fostering the development of safe, successful and more simple methods. Future developments in lead extraction are likely to focus on new tools that will allow us to provide comprehensive device management and the design of new leads conceived to facilitate future extraction. With the development of these new methods and novel tools, the technique of lead extraction will continue to require operators that are well versed in several methods of extraction. Garnering new skills while remembering the lessons of the past will enable extraction technologies to advance without repeating previous mistakes.

The role of cardiac surgery in transvenous lead extraction (TLE) – experience from high volume center and 3207 procedures

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
L Tulecki ◽  
M Czajkowski ◽  
S Targonska ◽  
K Tomkow ◽  
D Nowosielecka ◽  
...  
Keyword(s):  
Cardiac Surgery ◽  
Tricuspid Valve ◽  
Surgical Intervention ◽  
Clinical Success ◽  
Left Ventricular ◽  
Lead Extraction ◽  
Icd Leads ◽  
Ventricular Lead ◽  
Cardiac Surgeon

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 &lt;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

scholarly journals Transvenous lead extraction: procedural outcomes and in-hospital mortality in octogenarian patients

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
M Giannotti Santoro ◽  
L Segreti ◽  
G Zucchelli ◽  
V Barletta ◽  
A Di Cori ◽  
...  
Keyword(s):  
Elderly Patients ◽  
Hospital Mortality ◽  
Electronic Device ◽  
Clinical Success ◽  
Similar Efficacy ◽  
Lead Extraction ◽  
Tertiary Referral Center ◽  
Major Complications ◽  
Group 2 ◽  
Group 1

Abstract Background Managing elderly patients with infection or malfunction deriving from a cardiac implantable electronic device (CIED) may be challenging. The aim of this study was to evaluate safety and efficacy of mechanical transvenous lead extraction (TLE) in elderly patients. Methods Patients who had undergone TLE in single tertiary referral center were divided in two groups (Group 1: ≥80 years; group 2:&lt;80 years) and their acute and chronic outcomes were compared. All patients were treated with manual traction or mechanical dilatation. Results Our analysis included 1316 patients (group 1: 202, group 2: 1114 patients), with a total of 2513 leads extracted. Group 1 presented more comorbidities and more pacemakers, whereas the dwelling time of the oldest lead was similar, irrespectively of patient's age. In group 1 the radiological success rate for lead was higher (99.0% vs 95.9%; P&lt;0.001) and the fluoroscopy time lower (13.0 vs 15.0 minutes; P=0.04) than in group 2. Clinical success was reached in 1273 patients (96.7%), without significant differences between groups (group 1: 98.0% vs group 2: 96.4%; P=0.36). Major complications occurred in 10 patients (0.7%) without significative differences between patients with more or less than 80 years (group 1: 1.5% vs group 2: 0.6%; P=0.24). In the elderly group no in-hospital mortality occurred (0.0% vs 0.5%; P=0.42). Conclusions Mechanical TLE in elderly patients is a safe and effective procedure. In the over-80s, a comparable incidence of major complications with younger patients was observed, with at least a similar efficacy of the procedure and no procedural-related deaths. Funding Acknowledgement Type of funding source: None

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