The effect of centre volume and procedure location on major complications and mortality from transvenous lead extraction: an ESC EHRA EORP European Lead Extraction ConTRolled ELECTRa registry subanalysis

Abstract Aims Transvenous lead extraction (TLE) should ideally be undertaken by experienced operators in a setting that allows urgent surgical intervention. In this analysis of the ELECTRa registry, we sought to determine whether there was a significant difference in procedure complications and mortality depending on centre volume and extraction location. Methods and results Analysis of the ESC EORP European Lead Extraction ConTRolled ELECTRa registry was conducted. Low-volume (LoV) centres were defined as <30 procedures/year, and high-volume (HiV) centres as ≥30 procedures/year. Three thousand, two hundred, and forty-nine patients underwent TLE by a primary operator cardiologist; 17.1% in LoV centres and 82.9% in HiV centres. Procedures performed by primary operator cardiologists in LoV centres were less likely to be successful (93.5% vs. 97.1%; P < 0.0001) and more likely to be complicated by procedure-related deaths (1.1% vs. 0.4%; P = 0.0417). Transvenous lead extraction undertaken by primary operator cardiologists in LoV centres were associated with increased procedure-related major complications including death (odds ratio 1.858, 95% confidence interval 1.007–3.427; P = 0.0475). Transvenous lead extraction locations varied; 52.0% operating room, 9.5% hybrid theatre and 38.5% catheterization laboratory. Rates of procedure-related major complications, including death occurring in a high-risk environment (combining operating room and hybrid theatre), were similar to those undertaken in the catheterization laboratory (1.7% vs. 1.6%; P = 0.9297). Conclusion Primary operator cardiologists in LoV centres are more likely to have extractions complicated by procedure-related deaths. There was no significant difference in procedure complications between different extraction settings. These findings support the need for TLE to be performed in experienced centres with appropriate personnel present.

Download Full-text

Long-term follow-up of abandoned transvenous defibrillator leads: a nationwide cohort study

EP Europace ◽

10.1093/europace/euaa086 ◽

2020 ◽

Vol 22 (7) ◽

pp. 1097-1102

Author(s):

Anders Fyhn Elgaard ◽

Jens Brock Johansen ◽

Jens Cosedis Nielsen ◽

Christian Gerdes ◽

Sam Riahi ◽

...

Keyword(s):

Clinical Success ◽

Extraction Procedure ◽

Clinical Success Rate ◽

High Volume ◽

Lead Extraction ◽

Related Data ◽

Major Complications ◽

Long Term Follow Up

Abstract Aims Commonly, a dysfunctional defibrillator lead is abandoned and a new lead is implanted. Long-term follow-up data on abandoned leads are sparse. We aimed to investigate the incidence and reasons for extraction of abandoned defibrillator leads in a nationwide cohort and to describe extraction procedure-related complications. Methods and results All abandoned transvenous defibrillator leads were identified in the Danish Pacemaker and ICD Register from 1991 to 2019. The event-free survival of abandoned defibrillator leads was studied, and medical records of patients with interventions on abandoned defibrillator leads were audited for procedure-related data. We identified 740 abandoned defibrillator leads. Meantime from implantation to abandonment was 7.2 ± 3.8 years with mean patient age at abandonment of 66.5 ± 13.7 years. During a mean follow-up after abandonment of 4.4 ± 3.1 years, 65 (8.8%) abandoned defibrillator leads were extracted. Most frequent reason for extraction was infection (pocket and systemic) in 41 (63%) patients. Procedural outcome after lead extraction was clinical success in 63 (97%) patients. Minor complications occurred in 3 (5%) patients, and major complications in 1 (2%) patient. No patient died from complication to the procedure during 30-day follow-up after extraction. Conclusion More than 90% of abandoned defibrillator leads do not need to be extracted during long-term follow-up. The most common indication for extraction is infection. Abandoned defibrillator leads can be extracted with high clinical success rate and low risk of major complications at high-volume centres.

Download Full-text

P2857Implantable cardioverter defibrillator and pacemaker lead extraction: is it safe to do it again?

European Heart Journal ◽

10.1093/eurheartj/ehz748.1166 ◽

2019 ◽

Vol 40 (Supplement_1) ◽

Author(s):

A Cubberley ◽

P Sharedalal ◽

N Shah ◽

G Essilfie ◽

G Burkman ◽

...

Keyword(s):

Coronary Artery ◽

Electronic Device ◽

Artery Bypass ◽

Bypass Graft ◽

Systolic Heart Failure ◽

Adverse Outcomes ◽

Lead Extraction ◽

Major Complications ◽

Significant Difference ◽

First Time

Abstract Background/Introduction There are growing numbers of transvenous implantable devices for patients requiring permanent pacemakers (PPM) as well as Implantable Cardioverter Defibrillators (ICD). As such, there has been a concomitant increased need for lead extraction. Lead extraction is associated with increased morbidity and mortality (Hamid, 2010). Comparative outcomes of repeat lead extraction are not extensively studied. Purpose We compared demographics as well as major and minor adverse outcomes in patients undergoing first time vs. repeat lead extraction procedures. Methods In our single center study, 1278 extractions took place between January 2004 and December of 2018. Of these 1177 patients underwent PPM or ICD lead extraction for the first time; 101 patients underwent repeat extractions. Baseline characteristics including gender, history of coronary artery bypass graft (CABG) surgery, hypertension (HTN), systolic heart failure (HF) defined as ejection fraction <40%, hyperlipidemia (HLD), diabetes mellitus (DM), and coronary artery disease (CAD) were evaluated using chi-squared analysis. Adverse events, as defined by the 2017 HRS Expert Consensus Statement on Cardiovascular Implantable Electronic Device Lead Management and Extraction, were identified as major complications (death, cardiac arrest, cardiac perforation, coronary venous dissection, pericardial tamponade, or urgent cardiac surgery), and minor complications (coronary sinus dissection, pneumothorax, pocket bleeding requiring drainage, worsening tricuspid valve function, vegetation embolization, venous thrombosis, requirement of blood transfusion or lead migration). Results Comparing first time extractions vs repeat extractions, there was no significant difference in proportion of patients of female gender (32.4% vs. 28.3%, p=0.412), patients with prior CABG (23.0 vs. 23.4%, p=0.227), HTN (66.0% vs. 62.2%, p=0.462), HF (52.3% vs. 62.0%), HLD (39.6% vs 39.7%, p=0.682), DM (35.3% vs. 30.8%, p=0.387), or CAD (55.9% vs 56.0%, p=0.978). There was no significant difference in major complications (1.4% vs. 1.0%, p=0.749) and minor complications (3.5% vs 4.1%, p=0.741). Conclusion Patients undergoing repeat lead extractions showed very similar baseline demographics compared to first time lead extractions. Repeat extractions did not have increased rates of major or minor complications.

Download Full-text

Transvenous Lead Extraction SAFeTY Score for Risk Stratification and Proper Patient Selection for Removal Procedures Using Mechanical Tools

Journal of Clinical Medicine ◽

10.3390/jcm9020361 ◽

2020 ◽

Vol 9 (2) ◽

pp. 361 ◽

Cited By ~ 1

Author(s):

Wojciech Jacheć ◽

Anna Polewczyk ◽

Maciej Polewczyk ◽

Andrzej Tomasik ◽

Andrzej Kutarski

Keyword(s):

Young Patients ◽

High Volume ◽

Female Gender ◽

Lead Extraction ◽

Factors Associated ◽

Major Complications ◽

Proper Patient Selection ◽

Related Risk ◽

Risk Patients ◽

Selection For

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.

Download Full-text

P3137Transvenous lead extraction in patients under 30 years of age results from two high volume European centers

European Heart Journal ◽

10.1093/eurheartj/ehz745.0212 ◽

2019 ◽

Vol 40 (Supplement_1) ◽

Author(s):

W Jachec ◽

A Polewczyk ◽

L Segreti ◽

M G Bongiorni ◽

A Kutarski

Keyword(s):

Young People ◽

Clinical Success ◽

Young Patients ◽

High Volume ◽

Young Age ◽

Lead Extraction ◽

Specific Group ◽

Technical Problems ◽

Major Complications ◽

Simple Systems

Abstract Background Young patients are a specific group undergoing transvenous leads extraction (TLE) procedures due to different anatomy, intensive connecting tissue scar and earlier calcification. Aim Evaluation of results of TLE in young patients compared to adults above 30 years old Examined Groups and Methods: 3810 patients (mean age at the time of procedure; 65,21±15,84 years old, 1301 female) who underwent TLE procedures in two high volume experienced European centers (Poland and Italy). We compared clinical and procedural factors in two groups of patients: under the age of 30 (n=172) and between 30 and 80 (n=3054) with exclusion 584 patients above 80 years old. Results Results are presented in Table 1. A: p<0,05, AA; p<0,01, AAA; p<0,001, NS Conclusion Infective indications are less frequent in very young people. In spite of presence of simple systems in this patients the effectiveness of TLE remains lower- with documented lower rate of procedural and clinical success Young age does not influence on the appearance of major complications and procedure related death, however, the frequency of technical problems is increased due to necessity of extraction older, strongly ingrown, calcified leads. TLE in young patients is usually a big challenge and should be performed by the most experienced operators in high volume centers.

Download Full-text

The Influence of Lead-Related Venous Obstruction on the Complexity and Outcomes of Transvenous Lead Extraction

International Journal of Environmental Research and Public Health ◽

10.3390/ijerph18189634 ◽

2021 ◽

Vol 18 (18) ◽

pp. 9634

Author(s):

Marek Czajkowski ◽

Wojciech Jacheć ◽

Anna Polewczyk ◽

Jarosław Kosior ◽

Dorota Nowosielecka ◽

...

Keyword(s):

Clinical Success ◽

Technical Difficulty ◽

High Volume ◽

Lead Extraction ◽

Short Term ◽

Term Survival ◽

Major Complications ◽

Related Risk ◽

Short Term Mortality

Background: Little is known about lead-related venous stenosis/occlusion (LRVSO), and the influence of LRVSO on the complexity and outcomes of transvenous lead extraction (TLE) is debated in the literature. Methods: We performed a retrospective analysis of venograms from 2909 patients who underwent TLE between 2008 and 2021 at a high-volume center. Results: Advanced LRVSO was more common in elderly men with a high Charlson comorbidity index. Procedure duration, extraction of superfluous leads, occurrence of any technical difficulty, lead-to-lead binding, fracture of the lead being extracted, need to use alternative approach and lasso catheters or metal sheaths were found to be associated with LRVSO. The presence of LRVSO had no impact on the number of major complications including TLE-related tricuspid valve damage. The achievement of complete procedural or clinical success did not depend on the presence of LRVSO. Long-term mortality, in contrast to periprocedural and short-term mortality, was significantly worse in the groups with LRSVO. Conclusions: LRVSO can be considered as an additional TLE-related risk factor. The effect of LRVSO on major complications including periprocedural mortality and on short-term mortality has not been established. However, LRVSO has been associated with poor long-term survival.

Download Full-text

Risk stratification of patients undergoing transvenous lead extraction with the ELECTRa Registry Outcome Score (EROS): an ESC EHRA EORP European lead extraction ConTRolled ELECTRa registry analysis

EP Europace ◽

10.1093/europace/euab037 ◽

2021 ◽

Author(s):

Baldeep S Sidhu ◽

Salma Ayis ◽

Justin Gould ◽

Mark K Elliott ◽

Vishal Mehta ◽

...

Keyword(s):

Odds Ratio ◽

Surgical Repair ◽

Surgical Intervention ◽

Significant Risk ◽

Lead Extraction ◽

Major Complications ◽

Outcome Score ◽

Increased Risk ◽

Procedural Complications ◽

Registry Analysis

Abstract Aims Transvenous lead extraction is associated with a significant risk of complications and identifying patients at highest risk pre-procedurally will enable interventions to be planned accordingly. We developed the ELECTRa Registry Outcome Score (EROS) and applied it to the ELECTRa registry to determine if it could appropriately risk-stratify patients. Methods and results EROS was devised to risk-stratify patients into low risk (EROS 1), intermediate risk (EROS 2), and high risk (EROS 3). This was applied to the ESC EORP European Lead Extraction ConTRolled ELECTRa registry; 57.5% EROS 1, 31.8% EROS 2, and 10.7% EROS 3. Patients with EROS 3 or 2 were significantly more likely to require powered sheaths and a femoral approach to complete procedures. Patients with EROS 3 were more likely to suffer procedure-related major complications including deaths (5.1 vs. 1.3%; P < 0.0001), both intra-procedural (3.5 vs. 0.8%; P = 0.0001) and post-procedural (1.6 vs. 0.5%; P = 0.0192). They were more likely to suffer post-procedural deaths (0.8 vs. 0.2%; P 0.0449), cardiac avulsion or tear (3.8 vs. 0.5%; P < 0.0001), and cardiovascular lesions requiring pericardiocentesis, chest tube, or surgical repair (4.6 vs. 1.0%; P < 0.0001). EROS 3 was associated with procedure-related major complications including deaths [odds ratio (OR) 3.333, 95% confidence interval (CI) 1.879–5.914; P < 0.0001] and all-cause in-hospital major complications including deaths (OR 2.339, 95% CI 1.439–3.803; P = 0.0006). Conclusion EROS successfully identified patients who were at increased risk of significant procedural complications that require urgent surgical intervention.

Download Full-text

A Randomized Controlled Trial Comparing Alloderm-RTU with DermACELL in Immediate Subpectoral Implant-Based Breast Reconstruction

Current Oncology ◽

10.3390/curroncol28010020 ◽

2020 ◽

Vol 28 (1) ◽

pp. 184-195

Author(s):

Angel Arnaout ◽

Jing Zhang ◽

Simon Frank ◽

Moein Momtazi ◽

Erin Cordeiro ◽

...

Keyword(s):

Clinical Trial ◽

Breast Reconstruction ◽

Randomized Clinical Trial ◽

Operating Room ◽

Risk Difference ◽

Prospective Randomized Clinical Trial ◽

Major Complications ◽

Drain Removal ◽

Significant Difference ◽

Permanent Implant

Background: The effectiveness of different acellular dermal matrices (ADM) used for implant-based reconstruction immediately following mastectomy is an important clinical question. A prospective randomized clinical trial was performed to evaluate the superiority of DermACELL over Alloderm-RTU in reducing drain duration. Methods: Patients undergoing mastectomy with subpectoral immediate and permanent implant-based breast reconstruction were randomized to Alloderm-RTU or DermACELL. The primary outcome was seroma formation, measured by the duration of postoperative drain placement. Secondary outcomes included: post drain removal seroma aspiration, infection, redbreast syndrome, wound dehiscence, loss of the implant, and unplanned return to the operating room. Results: 62 patients were randomized for 81 mastectomies (41 Alloderm-RTU, 40 DermACELL). Baseline characteristics were similar. There was no statistically significant difference in mean drain duration (p = 0.16), with a trend towards longer duration in the Alloderm-RTU group (1.6 days; 95%CI, 0.7 to 3.9). The overall rate of minor and major complications were statistically similar between the two groups; although patients with Alloderm-RTU had 3 times as many infections requiring antibiotics (7.9% vs. 2.5%) with a risk difference of 5.4 (95%CI −4.5 to 15.2), and twice as many unplanned returns to the operating room (15.8% vs. 7.5%) with a risk difference of 8.3 (95% CI −5.9 to 22.5) as DermACELL. Conclusion: This is the first prospective randomized clinical trial comparing the two most commonly used human-derived ADMs. There was no statistically significant difference in drain duration, minor, or major complications between DermACELL over Alloderm-RTU in immediate subpectoral permanent implant-based breast reconstruction post-mastectomy.

Download Full-text

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

European Heart Journal ◽

10.1093/ehjci/ehaa946.0836 ◽

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 <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

Download Full-text

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

European Heart Journal ◽

10.1093/ehjci/ehaa946.0829 ◽

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:<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<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

Download Full-text

Fixation stability and implant-associated complications in periacetabular osteotomy: a comparison of screw and K-wire fixation

Archives of Orthopaedic and Trauma Surgery ◽

10.1007/s00402-021-04112-7 ◽

2021 ◽

Author(s):

Vincent Justus Leopold ◽

Juana Conrad ◽

Robert Karl Zahn ◽

Christian Hipfl ◽

Carsten Perka ◽

...

Keyword(s):

Soft Tissue ◽

Screw Fixation ◽

Periacetabular Osteotomy ◽

Implant Migration ◽

Major Complications ◽

Significant Difference ◽

Duration Of Surgery ◽

Wire Fixation ◽

Fixation Stability ◽

Screw Group

Abstract Aims The aim of this study was to compare the fixation stability and complications in patients undergoing periacetabular osteotomy (PAO) with either K-wire or screw fixation. Patients and methods We performed a retrospective study to analyze a consecutive series of patients who underwent PAO with either screw or K-wire fixation. Patients who were treated for acetabular retroversion or had previous surgery on the ipsilateral hip joint were excluded. 172 patients (191 hips: 99 K-wire/92 screw fixation) were included. The mean age at the time of PAO was 29.3 years (16–48) in the K-wire group and 27.3 (15–45) in the screw group and 83.9% were female. Clinical parameters including duration of surgery, minor complications (soft tissue irritation and implant migration) and major complications (implant failure and non-union) were evaluated. Radiological parameters including LCE, TA and FHEI were measured preoperatively, postoperatively and at 3-months follow-up. Results Duration of surgery was significantly reduced in the K-wire group with 88.2 min (53–202) compared to the screw group with 119.7 min (50–261) (p < 0.001). Soft tissue irritation occurred significantly more often in the K-wire group (72/99) than in the screw group (36/92) (p < 0.001). No group showed significantly more implant migration than the other. No major complications were observed in either group. Postoperative LCE, TA and FHEI were improved significantly in both groups for all parameters (p = < 0.0001). There was no significant difference for initial or final correction for the respective parameters between the two groups. Furthermore, no significant difference in loss of correction was observed between the two groups for the respective parameters. Conclusion K-wire fixation is a viable and safe option for fragment fixation in PAO with similar stability and complication rates as screw fixation. An advantage of the method is the significantly reduced operative time. A disadvantage is the significantly higher rate of implant-associated soft tissue irritation, necessitating implant removal. Level of evidence III, retrospective trial.

Download Full-text