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 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 Lead extraction for cardiac implantable electronic device infection: comparable complication rates with or without abandoned leads

EP Europace ◽  
2019 ◽  
Vol 21 (9) ◽  
pp. 1378-1384 ◽  
Author(s):  
Frank Bracke ◽  
Niels Verberkmoes ◽  
Marcel van 't Veer ◽  
Berry van Gelder
Keyword(s):  
Multivariate Analysis ◽  
Primary Endpoint ◽  
Electronic Device ◽  
Independent Predictor ◽  
Lead Extraction ◽  
Complication Rates ◽  
Clinical Failure ◽  
Cardiac Implantable Electronic Device ◽  
Major Complications ◽  
Device Infection

Abstract Aims Abandoned leads are often linked to complications during lead extraction, prompting pre-emptive extraction if leads become non-functional. We examined their influence on complications when extracted for device-related infection. Methods and results All patients undergoing lead extraction for device-related infection from 2006 to 2017 in our hospital were included. The primary endpoint was major complications. Out of 500 patients, 141 had abandoned leads, of whom 75% had only one abandoned lead. Median cumulative implant times were 24.2 (interquartile range 15.6–38.2) and 11.6 (5.6–17.4), respectively years with or without abandoned leads. All leads were extracted only with a femoral approach in 50.4% of patients. Mechanical rotational tools were introduced in 2014 and used in 22.2% of cases and replacing laser sheaths that were used in 5% of patients. Major complications occurred in 0.7% of patients with abandoned leads compared with 1.7% of patients with only active leads (P = 0.679). Failure to completely remove all leads was 14.9% and 6.4%, respectively with or without abandoned leads (P = 0.003), and clinical failure was 6.4% and 2.2% (P = 0.028), respectively. Procedural failure dropped to 9.2% and 5.7% (P = 0.37), respectively after the introduction of mechanical rotational tools. The only independent predictor of procedural and clinical failure in multivariate analysis was the cumulative implant duration. Conclusion Despite longer implant times, patients with abandoned leads did not have more major complications during lead extraction. Therefore, preventive extraction of non-functional leads to avoid complications at a later stage is not warranted.

Safety and efficacy of transvenous mechanical lead extraction in patients with abandoned leads

EP Europace ◽  
2020 ◽  
Vol 22 (9) ◽  
pp. 1401-1408
Author(s):  
Luca Segreti ◽  
Mario Giannotti Santoro ◽  
Andrea Di Cori ◽  
Federico Fiorentini ◽  
Giulio Zucchelli ◽  
...  
Keyword(s):  
Clinical Success ◽  
Lead Extraction ◽  
Safe Procedure ◽  
Optimal Management ◽  
Clinical Failure ◽  
Implantation Time ◽  
Safety And Efficacy ◽  
Dwelling Time ◽  
Group 2 ◽  
Group 1

Abstract Aims Optimal management of redundant or malfunctioning leads is controversial. We aimed to assess safety and efficacy of mechanical transvenous lead extraction (TLE) in patients with abandoned leads. Methods and results Consecutive TLE procedures performed in our centre from January 2009 to December 2017 were considered. We evaluated the safety and efficacy of mechanical TLE in patients with abandoned (Group 1) compared to non-abandoned (Group 2) leads. We analysed 1210 consecutive patients that required transvenous removal of 2343 leads. Group 1 accounted for 250 patients (21%) with a total of 617 abandoned leads (26%). Group 2 comprised 960 patients (79%) with 1726 leads (74%). The total number of leads (3.0 vs. 2.0), dwelling time of the oldest lead (108.00 months vs. 60.00 months) and infectious indications for TLE were higher in Group 1. Clinical success was achieved in 1168 patients (96.5%) with a lower rate in Group 1 (90.4% vs. 98.1%; P < 0.001). Major complications occurred in only 9 patients (0.7%), without significant differences among the two groups. The presence of one or more abandoned leads [odds ratio (OR) 3.47; 95% confidence interval (CI) 1.07–11.19; P = 0.037] and dwelling time of the oldest lead (OR 1.01 for a month; 95% CI 1.01–1.02; P < 0.001) were associated with a higher risk of clinical failure. Conclusion Transvenous mechanical lead extraction is a safe procedure also in high-risk settings, as patients with abandoned leads. Success rate resulted a bit lower, especially in the presence of abandoned leads with long implantation time.

Micra pacemaker implant after cardiac implantable electronic device extraction: feasibility and long-term outcomes

EP Europace ◽  
2019 ◽  
Vol 21 (8) ◽  
pp. 1229-1236 ◽  
Author(s):  
Giulio Zucchelli ◽  
Valentina Barletta ◽  
Veronica Della Tommasina ◽  
Stefano Viani ◽  
Matteo Parollo ◽  
...  
Keyword(s):  
Electronic Device ◽  
Superior Vena ◽  
Vena Cava ◽  
Electrical Performance ◽  
Lead Extraction ◽  
Safe Procedure ◽  
Group 2 ◽  
Group 1

Abstract Aims We aimed at investigating the feasibility and outcome of Micra implant in patients who have previously undergone transvenous lead extraction (TLE), in comparison to naïve patients implanted with the same device. Methods and results Eighty-three patients (65 males, 78.31%; 77.27 ± 9.96 years) underwent Micra implant at our centre. The entire cohort was divided between ‘post-extraction’ (Group 1) and naïve patients (Group 2). In 23 of 83 patients (20 males, 86.96%; 73.83 ± 10.29 years), Micra was implanted after TLE. Indication to TLE was an infection in 15 patients (65.21%), leads malfunction in four (17.39%), superior vena cava syndrome in three (13.05%), and severe tricuspid regurgitation in one case (4.35%). The implant procedure was successful in all patients and no device-related events occurred at follow-up (median: 18 months; interquartile range: 1–24). No differences were observed between groups in fluoroscopy time (13.88 ± 10.98 min vs. 13.15 ± 6.64 min, P = 0.45), single device delivery (Group 1 vs. Group 2: 69.56% vs. 55%, P = 0.22), electrical performance at implant and at 12-month follow-up (Group 1 vs. Group 2: pacing threshold 0.48 ± 0.05 V/0.24 ms vs. 0.56 ± 0.25 V/0.24 ms, P = 0.70; impedance 640 ± 148.83 Ohm vs. 583.43 ± 99.7 Ohm, P = 0.27; and R wave amplitude 10.33 ± 2.88 mV vs. 12.62 ± 5.31 mV, P = 0.40). A non-apical site of implant was achievable in the majority of cases (72.3%) without differences among groups (78.26% vs. 70%; P = 0.42). Conclusion Micra implant is an effective and safe procedure in patients still requiring a ventricular pacing after TLE, with similar electrical performance and outcome compared with naïve patients at long-term follow-up.

scholarly journals Geriatric Proximal Femur Fractures During the Covid-19 Pandemic - Fewer Cases, But More Comorbidities

2021 ◽  
Vol 12 ◽  
pp. 215145932110096
Author(s):  
Christina Polan ◽  
Heinz-Lothar Meyer ◽  
Manuel Burggraf ◽  
Monika Herten ◽  
Paula Beck ◽  
...  
Keyword(s):  
Nursing Home ◽  
Elderly Patients ◽  
Proximal Femur ◽  
Minor Trauma ◽  
Proximal Femur Fractures ◽  
Femur Fractures ◽  
Number Of Patients ◽  
Group 2 ◽  
The Impact ◽  
Group 1

Background: The COVID-19 pandemic is challenging healthcare systems worldwide. This study examines geriatric patients with proximal femur fractures during the COVID-19 pandemic, shifts in secondary disease profile, the impact of the pandemic on hospitalization and further treatment. Methods: In a retrospective monocentric study, geriatric proximal femur fractures treated in the first six months of 2020 were analyzed and compared with the same period of 2019. Pre-traumatic status (living in a care home, under supervision of a legal guardian), type of trauma, accident mechanism, geriatric risk factors, associated comorbidities, time between hospitalization and surgery, inpatient time and post-operative further treatment of 2 groups of patients, aged 65-80 years (Group 1) and 80+ years (Group 2) were investigated. Results: The total number of patients decreased (70 in 2019 vs. 58 in 2020), mostly in Group 1 (25 vs. 16) while the numbers in Group 2 remained almost constant (45 vs. 42). The percentage of patients with pre-existing neurological conditions rose in 2020. This corresponded to an increase in patients under legal supervision (29.3%) and receiving pre-traumatic care in a nursing home (14.7%). Fractures were mostly caused by minor trauma in a home environment. In 2020, total number of inpatient days for Group 2 was lower compared to Group 1 (p = 0.008). Further care differed between the years: fewer Group 1 patients were discharged to geriatric therapy (69.6% vs. 25.0%), whereas in Group 2 the number of patients discharged to a nursing home increased. Conclusions: Falling by elderly patients is correlated to geriatric comorbidities, consequently there was no change in the case numbers in this age group. Strategic measures to avoid COVID-19 infection in hospital setting could include reducing the length of hospital stays by transferring elderly patients to a nursing home as soon as possible and discharging independent, mobile patients to return home.

Transvenous lead extraction at the time of cardiac implantable electronic device upgrade: Complexity, safety, and outcomes

Heart Rhythm ◽  
2017 ◽  
Vol 14 (12) ◽  
pp. 1807-1811 ◽  
Author(s):  
Amr F. Barakat ◽  
Oussama M. Wazni ◽  
Khaldoun Tarakji ◽  
Walid I. Saliba ◽  
Nayef Nimri ◽  
...  
Keyword(s):  
Electronic Device ◽  
Lead Extraction ◽  
Cardiac Implantable Electronic Device

scholarly journals Assessing efficacy and safety of rectally vs. intravenously administered Sibazon in treatment of generalized epileptic seizures in children

2021 ◽  
Vol 13 (3) ◽  
pp. 200-210
Author(s):  
A. G. Prityko ◽  
K. V. Osipova ◽  
P. L. Sokolov ◽  
E. A. Ezhova ◽  
I. G. Kotel’nikova ◽  
...  
Keyword(s):  
Drug Administration ◽  
Epileptic Seizures ◽  
Blood Analysis ◽  
Intramuscular Administration ◽  
Final Visit ◽  
Fisher Exact Test ◽  
Efficacy And Safety ◽  
Clonic Seizures ◽  
Group 2 ◽  
Group 1

Objective: to prove the therapeutic equivalence and similar safety profile of “Sibazon, rectal solution” (international nonproprietary name: diazepam) and “Sibazon, solution for intravenous and intramuscular administration” in children with primary generalized and bilateral tonic, clonic and tonic-clonic seizures.Material and methods. An open-label, randomized clinical trial on efficacy and safety was conducted in 20 patients suffering from epilepsy with generalized seizures aged 1 to 17 years. Clinical blood and urine tests, biochemical blood analysis were used for diagnostics (glucose, total protein, albumin, total bilirubin, cholesterol, aspartate aminotransferase, alanine aminotransferase, creatine phosphokinase, alkaline phosphatase, creatinine, urea, creatinine clearance), as well as data on electrocardiographic (ECG) and electroencephalographic (EEG) studies. The patients were divided into two groups: in Group 1 (n=8), a rectal solution was used, in Group 2 (n=12) – a solution for intravenous and intramuscular administration.Results. The number of cases in which seizures were completed within 10 minutes after using the drug without resuming within subsequent 60 minutes, in Group 1 was 7 (87.5%), and in Group 2 – 9 (75.0%) (Fisher exact test (FET): p=0.617). Repeated primary generalized or bilateral tonic/clonic/tonic-clonic seizures within 24 hours after drug administration, in Group 1 were absent in 5 (62.5%) patients, in Group 2 – in 6 (50%) (FET: p=0.670); within 48 hours after drug administration – in 5 (62.5%) and 7 (58.3%) children, respectively (FET: p=1.00). Physical examination revealed no pathology in all patients at the final visit. While comparing ECG and EEG data at the final visit, no inter-group differences were found by the number of children with deviations from the norm. The results of laboratory studies confirmed that using the studied drugs had no negative effect on the main indicators of clinical and biochemical blood tests as well as clinical urine analysis.Conclusion. The effectiveness of the rectal form of Sibazon in relieving pediatric generalized epileptic seizures is comparable to that of Sibazon for intramuscular administration. The drug rectal form, due to easy-to-use administration, is preferable for outpatient practice. “Sibazon, rectal solution” is safe and has good tolerability.

Abstract 15948: Impact of Age on Safety of Radiofrequency Ablation in Patients With Atrial Fibrillation

Circulation ◽  
2014 ◽  
Vol 130 (suppl_2) ◽  
Author(s):  
Janet W Elcano ◽  
Hui Nam Pak
Keyword(s):  
Atrial Fibrillation ◽  
Phrenic Nerve Palsy ◽  
Adjusted Risk ◽  
Ablation Time ◽  
Group 4 ◽  
Major Complications ◽  
Group 3 ◽  
Group 2 ◽  
The Impact ◽  
Group 1

Background: The incidence of atrial fibrillation (AF) is increasing in the elderly population, however, there is paucity of data on the safety outcomes of this patient subgroup thus we sought to investigate on the impact of age on the safety of catheter ablation for AF. Methods and Results: We included 1,293 (male 75%) patients enrolled in Yonsei AF Ablation Cohort database in Seoul, South Korea, from March 2009 to November 2013. We divided the patients into 4 groups according to age (Group 1, aged 17-49, N=295 ; Group 2 50-59, N=421; Group 3 60-69 N=408; and Group 4 ≥ 70, N=169) and evaluated the incidence of procedure related complications. No procedure-related death occurred in this study. There was a trend of increasing incidence of procedure related complications with age noted as follows: Group 1= 3.7%; Group 2= 4.0%; Group 3=6.6%; and Group 4 7.1%, (p= 0.15). There were 28 cases (2.2%) of major complications (Group 1=1.7%, Group 2=1.9%, Group 3=2%, Group 4 4.1%), tamponade being the most common. Major complications in group 4 include: tamponade 4 cases, phrenic nerve palsy 1 case, atrioesophaeal fistula 1 and 3rd degree AV block in 1 patient. Multivariate regression analysis shows ablation time (odds ratio (OR) 1.2 confidence interval (CI)1.0-1.017, p=0.017), procedure time (OR 1.008, CI 1.0-1.15, p=0.04), decreasing eGFR (OR 1.013, CI 1.002-1.026 p=0.018), coronary artery disease (CAD) (OR 1.847, CI 1.003-3.524, p0.04) and age (OR 1.028, CI 1.003-1.055, p=0.03) were associated with increased adjusted risk of total complications. Predictors of major complications include age (OR 1.044, CI 1.003-1.086, p0.02) and ablation time (OR 1.009, CI 0.999-1.000, p=0.033). Conclusion: Our data suggest that incidence of procedural complications in RFA of AF increase with age. Ablation time and age are independent predictors of a major complication.

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

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

EP Europace ◽  
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.

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