1255Comprehensive analysis of pacemaker patients with and without abandoned leads undergoing transvenous lead extraction: A GALLERY subgroup analysis

EP Europace ◽  
2020 ◽  
Vol 22 (Supplement_1) ◽  
Author(s):  
D Chung ◽  
S Pecha ◽  
H Burger ◽  
V Moeller ◽  
T Madej ◽  
...  
Keyword(s):  
Electronic Device ◽  
Clinical Success ◽  
Vascular Complications ◽  
Systemic Infection ◽  
Female Gender ◽  
Lead Extraction ◽  
Success Rates ◽  
Device Infection ◽  
All Cause Mortality ◽  
Procedural Complications

Abstract OnBehalf GALLERY investigators Background The number of cardiac implantable electronic device (CIED)-associated complications such as infection, lead dysfunction or thrombotic events is continuously rising and thus making transvenous lead extraction (TLE) an ever more needed procedure in clinical practice today. Patients with abandoned leads represent a special cohort with a potentially higher susceptibility to CIED-related infections and vascular complications. Moreover, according to literature abandoned leads seem to be associated with more procedural complications and mortality during TLE.  Aim   The aim of this study was to provide an insight on safety, procedural outcome and risk prediction on pacemaker patients with abandoned leads undergoing TLE from the largest national laser-sheath registry to date. Methods + Results: We conducted a retrospective analysis of the GALLERY database, which collected 2533 patients undergoing TLE in Germany between 2013 and 2017. Out of 903 pacemaker patients, who underwent TLE, 226 patients (25.0%) with abandoned leads were identified. Those patients had a higher number of leads per patient (3.2 ± 0.8 vs. 1.9 ± 0.3; ns) and longer lead dwell-times (168.0 ± 89.7 vs. 123.0 ± 69.2 months; p < 0.0001) compared to pacemaker patients without abandoned leads. There were no differences in age (71.5 vs. 72.3 years; ns), body mass index (26.5 ± 4.5 vs. 26.78 ± 4.8 kg/m2; ns) or gender distribution (69.0 vs. 66.5% male; ns). Leading indication for TLE was device infection with no difference between groups (79.7 vs 77.8 %; ns). There were no differences in terms of pacemaker dependency, length of hospitalization or comorbidities. Patients with abandoned leads had longer procedure times (112.0 ± 69.0 vs. 86.4 ± 53.0 minutes; p < 0.0001) and a higher incidence of procedural complications (6.6 vs. 3.1%; p = 0.03), but there were no differences in neither procedural and clinical success rates (96.5 vs. 97.3%; ns), nor all-cause mortality (1.33 vs. 2.66%; ns). Multivariate logistic regression revealed abandoned leads (OR 2.1, CI 1.0-4.4, p = 0.04) and female gender (OR 2.4, CI 1.2-4.9, p = 0.02) as independent predictors for procedural complications. Systemic infection (OR 5.4, CI 2.0-14.8, p = 0.001) and chronic kidney disease (OR 4.0, CI 1.5-10.7, p = 0.007) were strong predictors for all-cause mortality in patients with indwelling pacemaker. Patient age > 75 years (OR 3.9, CI 2.7-5.6, p < 0.0001) and a lead dwell-time > 10 years (OR 1.6, CI 1.1-2.2, p = 0.01) were identified as risk factors for an infectious cause for TLE.  Conclusion Abandoned leads are frequently encountered in pacemaker patients undergoing TLE and pose an important risk factor for procedural complications. Systemic CIED-related infections are the strongest driver of mortality in this patient cohort and urgently call for further improvements in early diagnosis and prevention.

scholarly journals Performance of the padit score in patients undergoing transvenous lead extraction

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
J.P Dias Ferreira Reis ◽  
B Valente ◽  
V Ferreira ◽  
A Castelo ◽  
G Portugal ◽  
...  
Keyword(s):  
Cardiovascular Mortality ◽  
Clinical Success ◽  
Univariate Analysis ◽  
Clinical Success Rate ◽  
Lead Extraction ◽  
Mortality Data ◽  
First Year ◽  
All Cause Mortality ◽  
Procedural Complications

Abstract Background The PADIT trial identified 5 independent predictors of cardiac implantable electronic device (CIED) infection (prior procedure, age, chronic kidney disease, immunosuppression and type of procedure) and developed a novel infection risk score. Aim To assess whether the PADIT score (PS) could predict CIED reinfection and adverse events in patients (pts) submitted to transvenous lead extraction (LE) using the Pisa Technique (PT) due to CIED infection. Methods We conducted a single-centre prospective study of consecutive procedures (P) of LE using the PT between February 2013 and October 2019. Demographic, clinical, microbiological, device/ procedure related variables, morbidity and mortality data were retrieved during follow-up (FUP). An univariate analysis was performed to evaluate the ability of the PS to predict CIED reinfection (Re), procedural complications (C), all-cause hospital mortality (M), all-cause mortality/ hospitalization during first year of follow-up (MH1) and cardiovascular mortality (CM). Results A total 171 Ps including 159 pts, of which 80.7% (130 pts)were due to CIED infection: 55.1% due to pocket site infection, 18.8% to occult bacteremia with probable CIED infection and 26.1% due to both pocket site and systemic infection, with 44% of pts presenting with valvular/ lead vegetation (mean age - 70.3Y, 77.7% male, mean LVEF of 49.6%). The Rs rate was 93.1% and the clinical success rate was 99.2%. There were no deaths related to the procedure. During a mean FUP of 33 months, 11 pts had to undergo a new P, 5 of them due to pocket reinfection. The mortality rate was 24.2% (37 pts), with 8 pts dying during hospital stay, and 19 pts during the first year post-P. The mean PS was 2.9±2.5 (min- 0, max- 10). A higher PS value was associated with Re (HR - 1,43, CI95% 1.09–1.87, p=0.011), CM (HR - 1,39, CI95% 1.06–1.85, p=0.018) and MH1 (OR - 1,19, CI95% 1.03–1.38, p=0.021). There was no association between the PS and the rate of clinical success of the procedure (2.9% vs 4.5%, p=0.395), procedural complications (2.9% vs 3.3%, p=0.656) and M (4.0% vs 2.8%, p=0.192). Interestingly, a higher PS was not associated with a higher use of an antibacterial envelope during device reimplantation (3.5% vs 2.9%, p=0.371). Conclusion The PADIT score revealed a high predictive power for reinfection, all-cause mortality/ hospitalization during first year of follow-up and cardiovascular mortality in pts submitted to LE using the PT for CIED infection. 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:<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

scholarly journals A Historical Perspective of Cardiac Implantable Electronic Device Infection: How a Menace Can Drive Technological and Clinical Improvement

Hearts ◽  
2021 ◽  
Vol 2 (2) ◽  
pp. 202-212
Author(s):  
Giulia Massaro ◽  
Igor Diemberger ◽  
Matteo Ziacchi ◽  
Andrea Angeletti ◽  
Giovanni Statuto ◽  
...  
Keyword(s):  
Electronic Device ◽  
Positive Impact ◽  
Delayed Diagnosis ◽  
Implantation Rate ◽  
Major Complication ◽  
Lead Extraction ◽  
Cardiac Implantable Electronic Devices ◽  
Device Infection ◽  
New Perspective ◽  
Poor Outcomes

In recent decades there has been a relevant increase in the implantation rate of cardiac implantable electronic devices (CIEDs), albeit with relevant geographical inhomogeneities. Despite the positive impact on clinical outcomes, the possibility of major complications is not negligible, particularly with respect to CIED infections. CIED infections significantly affect morbidity and mortality, especially in instances of delayed diagnosis and appropriate treatment. In the present review, we will start to depict the factors underlying the development of CIED infection as well as the difficulties related to its diagnosis and treatment. We will explain the reasons underlying the need to focus on prophylaxis rather than treatment, in view of the poor outcomes despite improvements in lead extraction procedures. This will lead to the consideration of management of this complication in a hub-spoke manner, and to our analysis of the several technological and procedural improvements developed to minimize this complication. These include prolongation of CIED longevity, the development of leadless devices, and integrated prophylactic approaches. We will conclude with a discussion regarding new devices and strategies under development. This complete excursus will provide the reader with a new perspective on how a major complication can drive technological improvements.

Predictors of success and complications in laser lead extraction

EP Europace ◽  
2021 ◽  
Vol 23 (Supplement_3) ◽  
Author(s):  
T Madej ◽  
K Matschke ◽  
M Knaut
Keyword(s):  
Adverse Events ◽  
Electronic Device ◽  
Clinical Success ◽  
Multivariable Analysis ◽  
Lead Extraction ◽  
Predictors Of Success ◽  
Funding Sources ◽  
Icd Leads ◽  
Short Term Mortality ◽  
Major Adverse Events

Abstract Funding Acknowledgements Type of funding sources: None. Background Extraction of cardiac implantable electronic device (CIED) leads using excimer laser is in use since > 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 > 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 (< 4 cm rest) and the extraction failed in 1.3% of the leads (retention of ≥ 4 cm rest). Multivariable analysis identified lead age > 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) > 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 > 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 > 7.5 years, broken leads and ICD leads are independent predictors of failed extraction. CIED endocarditis, CRP > 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

1260Transvenous lead extraction: efficacy and safety of the procedure in octogenarian patients

EP Europace ◽  
2020 ◽  
Vol 22 (Supplement_1) ◽  
Author(s):  
M Giannotti Santoro ◽  
L Segreti ◽  
G Zucchelli ◽  
V Barletta ◽  
F Fiorentini ◽  
...  
Keyword(s):  
Elderly Patients ◽  
Electronic Device ◽  
Clinical Success ◽  
Lead Extraction ◽  
Efficacy And Safety ◽  
Cardiac Implantable Electronic Device ◽  
Major Complications ◽  
Group 2 ◽  
Manual Traction ◽  
Group 1

Abstract Introduction the management of patients with infection or malfunction of a cardiac implantable electronic device (CIED) may be challenging. Purpose The aim of the study is to evaluate the safety and efficacy of transvenous lead extraction (TLE) in elderly patients. Methods a retrospective analysis of patients who underwent to TLE in our center was performed. Patients were divided in two groups: 1) patients 80 years of age or older, 2) patients younger than 80 years. All patients were treated with manual traction or mechanical dilatation. Results our analysis included 1316 patients, with a total of 2513 leads extracted. Group 1 (≥80 years) counted 202 patients and group 2 (<80 years) 1114 patients. The group of elderly patients presented more comorbidities, as hypertension, chronic kidney disease, atrial fibrillation and pulmonary disease. Patients 80 years of age or older had more pacemakers than ICDs, whereas the dwelling time of the oldest lead, the number of leads and the presence of abandoned leads was similar despite patients age. In group 1 the rate of radiological success for lead was higher than in group 2 (99.0% vs 95.9%; P < 0.001). The clinical success was obtained in 1273 patients (96.7%), without significative differences between groups (98.0% vs 96.4%; P = 0.36). Major complications occurred in 10 patients (0.7%), without significative differences (1.5% vs 0.6%; P = 0.24) (figure 1). Conclusion TLE in elderly patients is a safe and effective procedure. In patients older than 80 years there are not more major complications than in younger patients, and the efficacy of the procedure seems to be superior. Abstract Figure 1

scholarly journals Ceftolozane/tazobactam versus colistin in the treatment of ventilator-associated pneumonia due to extensively drug-resistant Pseudomonas aeruginosa: a comparative cohort study

2021 ◽  
Author(s):  
Bence Mogyoródi ◽  
András Csékó ◽  
Csaba Hermann ◽  
János Gál ◽  
Zsolt Iványi
Keyword(s):  
Pseudomonas Aeruginosa ◽  
Clinical Success ◽  
Tertiary Care ◽  
Kidney Injury ◽  
Multivariate Regression Analysis ◽  
Ventilator Associated Pneumonia ◽  
Drug Resistant ◽  
Success Rates ◽  
Extensively Drug Resistant ◽  
All Cause Mortality

Abstract Background Resistant strains of Pseudomonas aeruginosa are common pathogens in the intensive care unit (ICU), limiting available therapeutic options. We aimed to compare ceftolozane/tazobactam (C/T) with colistimethate sodium (CMS) in the treatment of ventilator-associated pneumonia (VAP) due to extensively drug-resistant (XDR) Pseudomonas aeruginosa. Methods A retrospective, observational study was performed at a tertiary care ICU. Clinical and microbiological success rate, 28-day all-cause mortality, and adverse events were compared in patients who received C/T with those treated with systemic CMS. Results A total of 51 patients were included (18 in the C/T and 33 in the CMS group). Clinical success rates in the C/T and CMS groups were 13 (72.2 %) and 10 (30.3 %), respectively. On multivariate regression analysis, treatment with C/T was independently associated with clinical success (odds ratio 4.47, 95% CI = 1.17–17.08). There was no difference in 28-day all-cause mortality (27.8 % and 33.3 % in the C/T and CMS group, p = 0.76). Acute kidney injury was more common in patients who received CMS (48.5 % vs 11.1 %, p = 0.01). Conclusions Ceftolozane/tazobactam proved to be efficient in the treatment of XDR Pseudomonas aeruginosa VAP and showed a better safety profile compared to CMS.

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 < 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 < 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.

Consensus document on management of cardiac implantable electronic de­vice leads and lead extraction

2018 ◽  
Vol 2 (47) ◽  
pp. 4-9
Author(s):  
Przemysław Mitkowski
Keyword(s):  
Electronic Device ◽  
Clinical Success ◽  
Final Diagnosis ◽  
Lead Extraction ◽  
Infective Complication ◽  
Consensus Document ◽  
Residual Part ◽  
Definition Of ◽  
Expert Consensus Document

New expert consensus document is a result of cooperation of 10 worldwide scientific societes, including HRS and EHRA, updates knowledge and recommendations on management of cardiac implantable electronic device leads and lead extraction. The definition of extraction clinical success was changed limiting the residual part of the lead left in cardiovascular system to 4 cm. Significant part of the document is dedicated to diagnosis of lead failure and its differential diagnosis with other reasons which cause a lead malfunction. New precise definition of different examples of infective complication of CIED from pocket erosion to CIED endocarditis were established. Antibiotic therapy is necessary after all extractions due to infective complication but its longevity should be form 10 days to 6 weeks or more depending on the final diagnosis. All infective indications for lead extraction except for superficial incisional infection belongs to class I indications. Numerous indications for lead extraction due to non-infective indications were simplified and class of recommendation has been lowered. Periprocedural management of patients has been described in details. Risk factors of complications and long term mortality were listed.

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