385 results on '"Device Removal methods"'
Search Results
2. Outcomes of complete removal versus conservative therapy in cardiac implantable electronic device infections - A systematic review and Meta-analysis.
- Author
-
Caldonazo T, Fischer J, Spagnolo A, Dell'Aquila M, Kirov H, Tasoudis P, Treml RE, Vervoort D, Sá MP, Doenst T, Diab M, and Hagel S
- Subjects
- Humans, Treatment Outcome, Conservative Treatment methods, Anti-Bacterial Agents therapeutic use, Prosthesis-Related Infections therapy, Defibrillators, Implantable adverse effects, Device Removal methods, Pacemaker, Artificial adverse effects
- Abstract
Background: Complete removal of cardiac implantable electronic devices (CIEDs) is recommended in patients with CIED infections, including both systemic and localized pocket infection. The aim of the study was to provide an up-to-date and comprehensive assessment of evidence relating to the effect of complete CIED extraction in patients with a CIED infection., Methods: We performed a systematic review and meta-analysis of studies reporting short- and mid-term outcomes in patients who had a device infection or infective endocarditis (IE) and underwent complete removal of the cardiac device (generator and leads) compared to those who received conservative therapy (no removal, partial removal, local antibiotic infiltration or isolated antibiotic therapy). The primary outcome was reinfection/relapse. Secondary outcomes were short-term (30-day/in-hospital) and mid-term (mean follow-up: 43.0 months) mortality. Random effects model was performed., Results: Thirty-two studies met the criteria for inclusion in the final analysis. Patients with complete CIED extraction (n = 905) exhibited a lower rate of relapse/re-infection compared to patients (n = 195) with a conservative treatment approach (n = 195, OR 0.02, 95%CI 0.01-0.06, p < 0.0001, mean-follow-up: 16.1 months). Additionally, these patients displayed a lower short- (OR 0.40, 95%CI 0.23-0.69, p = 0.01) and mid-term (OR 0.52, 95%CI 0.34-0.78, p = 0.002) mortality., Conclusions: The analysis indicates that patients with a CIED infection who undergo complete CIED extraction exhibit a lower rate of relapse/re-infection. Additionally, a lower short- and mid-term mortality is observed, although it is acknowledged that this outcome may be influenced by treatment allocation bias., Competing Interests: Declaration of competing interest None., (Copyright © 2024 The Authors. Published by Elsevier B.V. All rights reserved.)
- Published
- 2024
- Full Text
- View/download PDF
3. Preoperative and Intraoperative Imaging during Transvenous Lead Extraction.
- Author
-
Berbenetz NM, Golian M, and Sadek MM
- Subjects
- Humans, Preoperative Care methods, Fluoroscopy, Echocardiography, Transesophageal, Device Removal methods, Defibrillators, Implantable adverse effects, Pacemaker, Artificial adverse effects
- Abstract
Transvenous lead extraction is performed for device infection, lead failure, or to provide access for additional leads/device upgrade. A patient-centered risk assessment for transvenous lead extraction can be determined using a combination of clinical factors and several imaging modalities. Predicting a complex lead extraction, for example, one that will require powered tools or the use of a femoral approach, is aided by pre-procedural imaging and clinical assessment. Procedural imaging utilizing fluoroscopy, transesophageal echocardiography, and intracardiac echocardiography during an extraction can improve safety and identify complications rapidly., Competing Interests: Disclosure The authors have nothing to disclose., (Copyright © 2024 Elsevier Inc. All rights reserved.)
- Published
- 2024
- Full Text
- View/download PDF
4. Cardiac Device Implantation: Techniques and Best Practices.
- Author
-
Pillai A, Huizar JF, Koneru JN, and Kaszala K
- Subjects
- Humans, Prosthesis-Related Infections prevention & control, Device Removal methods, Prosthesis Implantation, Risk Factors, Defibrillators, Implantable adverse effects, Pacemaker, Artificial adverse effects
- Abstract
Transvenous leads continue to be the standard means to deliver bradyarrhythmia and tachyarrhythmia device therapy. Risk factors for cardiac implantable electronic devices (CIED) infection or complications of transvenous lead extraction (TLE) and mortality represent a complex interplay between non-modifiable patient-related factors and actionable implant-related characteristics or adverse events. Careful attention to patient screening, infection mitigation, lead selection, and implant technique may enhance safety of the index procedure and subsequent clinical management., (Copyright © 2024 Elsevier Inc. All rights reserved.)
- Published
- 2024
- Full Text
- View/download PDF
5. Indications and Techniques for Surgical Lead Extraction and Device Reimplantation.
- Author
-
Lee AJ and Bashir J
- Subjects
- Humans, Replantation, Device Removal methods, Device Removal instrumentation, Defibrillators, Implantable adverse effects, Pacemaker, Artificial
- Abstract
Cardiac implantable electronic devices (CIEDs) can be lifesaving but complications associated with CIEDs can lead to significant morbidity and mortality. Effective techniques to remove these devices are critical to reducing complications and improving quality of life. Percutaneous extraction techniques are effective for removing the majority of CIEDs but surgical lead extraction is still required in certain situations. Surgical lead extraction volumes are generally low at most centers but familiarity with the techniques and principles is important for maintaining a comprehensive lead management program. This review discusses indications and techniques for surgical lead extraction and considerations for device reimplantation., Competing Interests: Disclosure A.J. Lee does not have any financial disclosures. J. Bashir has consulting fees and research grants from Boston Scientific, Cook Medical and Edwards Lifesciences., (Copyright © 2024 Elsevier Inc. All rights reserved.)
- Published
- 2024
- Full Text
- View/download PDF
6. Indications for Lead Extraction.
- Author
-
Pokorney SD
- Subjects
- Humans, Prosthesis-Related Infections surgery, Device Removal methods, Defibrillators, Implantable, Pacemaker, Artificial
- Abstract
Cardiac implantable electronic devices (CIEDs) are being implanted at increasing rates. Patients with CIEDs require more lead management in contemporary clinical practice, given the increased survival of heart failure patients. There are multiple indications for extraction with the strongest class I indications being in patients with CIED infections. Extraction with complete hardware removal is underutilized and often delayed when it is utilized in patients with CIED infections, resulting in higher mortality. Patient and provider preferences are critical to decision-making when considering extraction. Lead extraction referral and management care pathways are needed in order to optimize care for our patients with CIEDs., (Copyright © 2024 Elsevier Inc. All rights reserved.)
- Published
- 2024
- Full Text
- View/download PDF
7. Comprehensive analysis of substernal lead removal: experience from EV ICD Pilot, Pivotal, and Continued Access Studies.
- Author
-
Sagi V, Murgatroyd F, Boersma LVA, Manlucu J, Knight BP, Leclercq C, Amin A, Birgersdotter-Green UM, Chan JYS, Roukoz H, Biffi M, Haqqani H, Denman R, Wiggenhorn C, Holmes TR, Lulic T, Friedman P, and Crozier I
- Subjects
- Humans, Female, Middle Aged, Male, Retrospective Studies, Aged, Adult, Treatment Outcome, Death, Sudden, Cardiac prevention & control, Death, Sudden, Cardiac etiology, Pilot Projects, Time Factors, Electric Countershock instrumentation, Electric Countershock adverse effects, Defibrillators, Implantable, Device Removal methods
- Abstract
Aims: The extravascular implantable cardioverter-defibrillator (EV ICD) has been shown to be safe and effective for patients at risk of sudden cardiac death, but little is known about EV ICD lead removal in humans. This analysis aimed to characterize the EV ICD lead removal experience thus far., Methods and Results: This was a retrospective analysis of lead removals from the EV ICD Pilot, Pivotal, and Continued Access Studies. Patients with a successful EV ICD implant who underwent lead removal were included. The main objective was lead removal success. Ancillary objectives included characterizing technique used, procedure complications, and reimplantation status. An EV ICD system was successfully implanted in 347 patients across the 3 studies (25.9% female; 53.4 ± 13.3 years; left ventricular ejection fraction: 39.7 ± 15.9). Of these patients, 29 (8.4%) underwent lead removal with a mean lead dwell time of 12.6 ± 14.3 months (0.2-58.4). The main reason for lead removal was lead dislodgement (n = 9, 31.0%). Lead removal was successful in 27/29 (93.1%) cases [100% (19/19) success rate <1 year and 80% (8/10) success rate >1 year post-implant]. Simple traction was used in 22/26 (84.6%) and extraction tools in 4/26 (15.4%) successful cases where technique was known. No complications were reported for any of the removal procedures. All 11 EV ICD reimplant attempts were successful., Conclusion: Complete removal of the EV ICD lead was successful in 93.1% of cases, and simple traction was sufficient in most instances. Based on these results, lead removal from the substernal space was safe and achievable up to 3 years post-implant., (© The Author(s) 2024. Published by Oxford University Press on behalf of the European Society of Cardiology.)
- Published
- 2024
- Full Text
- View/download PDF
8. Percutaneous Extraction of Transvenous Permanent Pacemaker/Defibrillator Leads-A Single-Center Experience.
- Author
-
Akcay M and Yuksel S
- Subjects
- Humans, Aged, Male, Female, Retrospective Studies, Middle Aged, Aged, 80 and over, Treatment Outcome, Cohort Studies, Pacemaker, Artificial adverse effects, Device Removal methods, Device Removal statistics & numerical data, Defibrillators, Implantable adverse effects, Defibrillators, Implantable statistics & numerical data
- Abstract
Background and Objectives : The number of cardiac pacemakers being used has increased in recent decades, and this increase has led to a rise in device-related complications, requiring percutaneous device extraction. Our aim was to present our single-center clinical experience in percutaneous lead extractions. Materials and Methods : We analyzed an observational retrospective cohort study of 93 patients for the transvenous removal of a total of 163 endocardial leads. We evaluated the device details, indications, lead characteristics, extraction methods, complications, reimplantation procedure, follow-up data, effectiveness, and safety. Results : Patients' mean age was 68.6 ± 11.6 years. Lead extraction indications were pocket infection in 33 (35.5%), lead dysfunction in 33 (35.5%), and system upgrade in 21 (23%) cases, and lead endocarditis in 6 (6%) cases. The duration from implantation to extraction time was a detected median of 43 (24-87) months. The most common retracted lead type was the RV defibrillator lead (62%), and the lead fixation type was active for one hundred (61%) patients. A new device was inserted in 74 (80%) patients, and the device type was most commonly a CRT-D (61%). Patients were followed up at a median of 17 (8-36) months, and 18 patients (19%) died at follow-up. Complete procedural success was obtained in 78 (84%) patients, and clinical procedural success was obtained in 83 (89%) patients. Procedural failure was detected in 15 (16%) patients. Major and minor complications were detected in 10 (11%) and 6 (6.5%) patients, respectively. The most common minor complication was pocket hematoma. Conclusions : Our experience suggests that transvenous lead extraction has a high success rate with an acceptable risk of procedural complications. The simple manual traction method has a high rate of procedural success, despite a high dwell time of the lead.
- Published
- 2024
- Full Text
- View/download PDF
9. Four-Stage Rocket technique: A novel strategy for lead extractions using laser sheaths from the femoral vein.
- Author
-
Kawano D, Matsumoto K, Narita M, Tanaka N, Naganuma T, Sasaki W, Mori H, Ikeda Y, and Kato R
- Subjects
- Humans, Male, Aged, Treatment Outcome, Female, Middle Aged, Catheterization, Peripheral instrumentation, Device Removal instrumentation, Device Removal methods, Femoral Vein, Defibrillators, Implantable, Pacemaker, Artificial, Lasers
- Abstract
Introduction: Transvenous lead extractions (TLEs) for cardiac implantable electronic device complications often encounter difficulties with strong adhesions to the myocardium or vessels. In this report, we introduce a novel "Four-Stage Rocket" technique for effective TLE in cases where conventional methods fail., Methods and Results: Two challenging cases where conventional TLE methods failed were treated using a combination of four devices: Needle's Eye Snare, Agilis NxT Steerable Introducer, GlideLight Laser sheath, and GORE® DrySeal Flex Introducer sheath, employed via the inferior vena cava. The "Four-Stage Rocket" technique successfully detached firmly adhered leads near the tricuspid valve annulus, where the traditional superior vena cava approach was inadequate., Conclusion: The "Four-Stage Rocket" technique offers a potential alternative in complex TLE cases, aligning the laser direction with the adhesion detachment and reducing the tissue damage risk., (© 2024 The Author(s). Journal of Cardiovascular Electrophysiology published by Wiley Periodicals LLC.)
- Published
- 2024
- Full Text
- View/download PDF
10. Open Chest Approach Lead Extraction in a Patient with a Large Vegetation: The Importance of Multidisciplinary Approach, Advanced Imaging, and Procedural Planning.
- Author
-
Lacharite-Roberge AS, Patel K, Yang Y, Birgersdotter-Green U, and Pollema TL
- Subjects
- Humans, Male, Echocardiography, Transesophageal, Tomography, X-Ray Computed, Aged, Foramen Ovale, Patent surgery, Foramen Ovale, Patent diagnostic imaging, Female, Middle Aged, Device Removal methods, Defibrillators, Implantable adverse effects, Prosthesis-Related Infections surgery, Prosthesis-Related Infections diagnostic imaging, Pacemaker, Artificial adverse effects
- Abstract
We present a complex case of cardiac implantable electronic device infection and extraction in the setting of bacteremia, large lead vegetation, and patent foramen ovale. Following a comprehensive preprocedural workup including transesophageal echocardiogram and computed tomography lead extraction protocol, in addition to the involvement of multiple subspecialties, an open chest approach to extraction was deemed a safer option for eradication of the patient's infection. Despite percutaneous techniques having evolved as the preferred extraction method during the last few decades, this case demonstrates the importance of a thorough evaluation at an experienced center to determine the need for open chest extraction., Competing Interests: Disclosure There are no financial conflicts of interest to disclose., (Copyright © 2023 Elsevier Inc. All rights reserved.)
- Published
- 2024
- Full Text
- View/download PDF
11. Coronary venous lead reimplantation vs. left bundle branch area pacing crossover following cardiac resynchronization therapy defibrillator extraction: a single-centre experience.
- Author
-
Baroni M, Preda A, Carbonaro M, Fortuna M, Guarracini F, Gigli L, and Mazzone P
- Subjects
- Humans, Male, Aged, Female, Middle Aged, Treatment Outcome, Bundle of His physiopathology, Replantation methods, Coronary Vessels surgery, Coronary Vessels diagnostic imaging, Coronary Vessels physiopathology, Heart Failure therapy, Heart Failure physiopathology, Electric Countershock instrumentation, Retrospective Studies, Defibrillators, Implantable, Cardiac Resynchronization Therapy methods, Cardiac Resynchronization Therapy Devices, Device Removal methods
- Abstract
Competing Interests: Conflict of interest: none declared.
- Published
- 2024
- Full Text
- View/download PDF
12. Pacing and Defibrillation Consideration in the Era of Transcatheter Tricuspid Valve Replacement.
- Author
-
Dhindsa DS, Mekary W, and El-Chami MF
- Subjects
- Humans, Cardiac Catheterization methods, Cardiac Pacing, Artificial methods, Heart Valve Prosthesis, Device Removal methods, Tricuspid Valve Insufficiency surgery, Defibrillators, Implantable, Tricuspid Valve surgery, Heart Valve Prosthesis Implantation methods, Pacemaker, Artificial
- Abstract
Purpose of Review: Tricuspid regurgitation is a commonly encountered valvular pathology in patients with trans-tricuspid pacing or implantable cardioverter-defibrillator leads. Transcatheter tricuspid valve interventions are increasingly performed in patients at high surgical risk. Implantation of these valves can lead to the "jailing" of a trans-tricuspid lead. This practice carries both short- and long-term risks of lead failure and subsequent infection without the ability to perform traditional transvenous lead extraction. Herein, this manuscript reviews available therapeutic options for lead management in patients undergoing transcatheter tricuspid valve interventions., Recent Findings: The decision to jail a lead may be appropriate in certain high-risk cases, though extraction may be a better option in most cases given the variety of options for re-implant, including leadless pacemakers, valve-sparing systems, epicardial leads, leads placed directly through prosthetic valves, and the completely subcutaneous implantable-defibrillator. A growing number of patients meet the requirement for CIED implantation in the United States. A significant proportion of these patients will have tricuspid valve dysfunction, either related to or independent of their transvenous lead. As with any percutaneous intervention that has shown efficacy, the role of TTVI is also likely to increase as this therapy advances beyond the investigational phase. As such, the role of the heart team in the management of these patients will be increasingly critical in the years to come, and in those patients that have pre-existing CIED leads, we advocate for the involvement of an electrophysiologist in the heart team., (© 2024. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.)
- Published
- 2024
- Full Text
- View/download PDF
13. Outcomes of Transvenous Lead Extraction in a Referral Center in Northern Israel.
- Author
-
Haddad R, Birati E, Zayyad H, Andria N, Nachum E, Kachel E, and Marai I
- Subjects
- Humans, Male, Israel epidemiology, Female, Aged, Retrospective Studies, Treatment Outcome, Middle Aged, Electrodes, Implanted, Aged, 80 and over, Device Removal methods, Device Removal statistics & numerical data, Defibrillators, Implantable, Pacemaker, Artificial
- Abstract
Background: Cardiac implantable electronic devices (CIEDs) are increasingly being used; thus, there is an increasing need for transvenous lead extraction (TLE)., Objectives: To summarize our experience with TLE at single referral center in northern Israel., Methods: The study included all patients who underwent TLE at our center between 2019 and 2022, regardless of the indication., Results: The cohort included 50 patients. The mean age was 69 ± 10.36 years; 78% were males. A total of 99 electrodes were targeted. The mean number of electrodes was 1.96 (range 1-4) per patient. The time between lead implantation and extraction ranged between 1.1 and 34 years with an average of 8.14 ± 5.71 years (median of 7.5 years). Complete lead removal was achieved in 98% of patients and in 98.99% of leads. The complete procedural success rate as well as the clinical procedural success rate was 96%. The procedural failure rate was 4% (1 patient died 2 days after the index procedure and 1 patient remained with large portion of lead). The indication for TLE was infection in 78% of the cohort group. Powered mechanical sheaths were used in 36 patients (72%), laser sheaths in 27 (54%), and a combination of laser and mechanical sheaths in 16 (32%)., Conclusions: The clinical and procedural success rates of TLE, primarily for CEID-related infection, were high. A combination of laser and mechanical sheaths was needed in one-third of patients.
- Published
- 2024
14. Late recognition of cardiac implantable electronic device misplacement in left ventricle: a case report.
- Author
-
Bahrami F, Sattartabar B, Larti F, Rahmanian M, and Mollazadeh R
- Subjects
- Humans, Echocardiography methods, Device Removal methods, Heart Septal Defects, Atrial surgery, Heart Septal Defects, Atrial diagnosis, Male, Female, Pacemaker, Artificial adverse effects, Middle Aged, Defibrillators, Implantable adverse effects, Heart Ventricles diagnostic imaging
- Abstract
Background: Cardiac electronic device implantation may be associated with complications. Case Summary: This is a report of inadvertent implantation of implantable cardioverter-defibrillator lead through an unrecognized sinus venosus atrial septal defect into the left ventricle that was not diagnosed early after implantation. Six months later chest x-ray showed an abnormal lead course that was confirmed with echocardiography as to be in the left ventricle. Surgical removal of the implantable cardioverter-defibrillator lead, repair of atrial septal defect, and correction of abnormal pulmonary venous connections were performed. Meanwhile, follow-up of the patient receiving a new dual chamber permanent pacemaker from the contralateral side and discussion of the aforementioned complication are addressed. Conclusion: Early diagnosis of device implantation complication is of paramount importance and prevents potential catastrophic complications.
- Published
- 2024
- Full Text
- View/download PDF
15. Transvenous lead extraction safety and efficacy in infected and noninfected patients using mechanical-only tools: Prospective registry from a high-volume center.
- Author
-
Gładysz-Wańha S, Joniec M, Wańha W, Piłat E, Drzewiecka A, Gardas R, Biernat J, Węglarzy A, and Gołba KS
- Subjects
- Humans, Male, Middle Aged, Aged, Female, Treatment Outcome, Device Removal methods, Registries, Retrospective Studies, Pacemaker, Artificial adverse effects, Defibrillators, Implantable adverse effects, Heart Diseases etiology
- Abstract
Background: Transvenous lead extraction (TLE) is a well-established treatment option for patients with cardiac implantable electronic devices (CIED) complications., Objective: The purpose of this study was to evaluate the safety and efficacy of TLE in CIED infection and non-CIED infection patients., Methods: Consecutive patients who underwent TLE between 2016 and 2022 entered the EXTRACT Registry. Models of prediction were constructed for periprocedural clinical and procedural success and the incidence of major complications, including death in 30 days., Results: The registry enrolled 504 patients (mean age 66.6 ± 12.8 years; 65.7% male). Complete procedural success was achieved in 474 patients (94.0%) and clinical success in 492 patients (97.6%). The total number of major and minor complications was 16 (3.2%) and 51 (10%), respectively. Three patients (0.6%) died during the procedure. New York Heart Association functional class IV and C-reactive protein levels defined before the procedure were independent predictors of any major complication, including death in 30 days in CIED infection patients. The time since the last preceding procedure and platelet count before the procedure were independent predictors of any major complication, including death in 30 days in non-CIED infection patients., Conclusions: TLE is safe and successfully performed in most patients, with a low major complication rate. CIED infection patients demonstrate better periprocedural clinical success and complete procedural success. However, CIED infection predicts higher 30-day mortality compared with non-CIED infection patients. Predictors of any major complication, including death in 30 days, differ between CIED infection and non-CIED infection patients., (Copyright © 2024 Heart Rhythm Society. Published by Elsevier Inc. All rights reserved.)
- Published
- 2024
- Full Text
- View/download PDF
16. Success and safety of deep sedation as a primary anaesthetic approach for transvenous lead extraction: a retrospective analysis.
- Author
-
Schiedat F, Fischer J, Aweimer A, Schöne D, El-Battrawy I, Hanefeld C, Mügge A, and Kloppe A
- Subjects
- Humans, Female, Male, Midazolam adverse effects, Retrospective Studies, Pirinitramide, Device Removal adverse effects, Device Removal methods, Treatment Outcome, Etomidate, Deep Sedation adverse effects, Deep Sedation methods, Anesthetics, Defibrillators, Implantable, Pacemaker, Artificial adverse effects
- Abstract
There is a rising number in complications associated with more cardiac electrical devices implanted (CIED). Infection and lead dysfunction are reasons to perform transvenous lead extraction. An ideal anaesthetic approach has not been described yet. Most centres use general anaesthesia, but there is a lack in studies looking into deep sedation (DS) as an anaesthetic approach. We report our retrospective experience for a large number of procedures performed with deep sedation as a primary approach. Extraction procedures performed between 2011 and 2018 in our electrophysiology laboratory have been included retrospectively. We began by applying a bolus injection of piritramide followed by midazolam as primary medication and would add etomidate if necessary. For extraction of leads a stepwise approach with careful traction, locking stylets, dilator sheaths, mechanical rotating sheaths and if needed snares and baskets has been used. A total of 780 leads in 463 patients (age 69.9 ± 12.3, 31.3% female) were extracted. Deep sedation was successful in 97.8% of patients. Piritramide was used as the main analgesic medication (98.5%) and midazolam as the main sedative (94.2%). Additional etomidate was administered in 15.1% of cases. In 2.2% of patients a conversion to general anaesthesia was required as adequate level of DS was not achieved before starting the procedure. Sedation related complications occurred in 1.1% (n = 5) of patients without sequalae. Deep sedation with piritramide, midazolam and if needed additional etomidate is a safe and feasible strategy for transvenous lead extraction., (© 2023. The Author(s).)
- Published
- 2023
- Full Text
- View/download PDF
17. Extraction outcomes of implantable cardioverter-defibrillator leads vary by manufacturer and model family.
- Author
-
Hayashi K, Callahan T, Rickard J, Younis A, Baranowski B, Martin D, Nakhla S, Tabaja C, and Wilkoff BL
- Subjects
- Humans, Child, Adolescent, Prospective Studies, Device Removal adverse effects, Device Removal methods, Retrospective Studies, Treatment Outcome, Defibrillators, Implantable adverse effects, Pacemaker, Artificial
- Abstract
Aims: Transvenous lead extraction (TLE) of implantable cardioverter-defibrillator (ICD) leads is considered challenging. The structure of each ICD leads is variable between manufacturer and model families. The net impact of lead family on the safety and effectiveness of TLE is poorly characterized. We assessed the safety and efficacy of ICD TLE and the impact of manufacturer ICD model family on the outcomes., Methods and Results: The study cohort included all consecutive patients with ICD who underwent TLE between 2013 and 2022 and are enrolled in the Cleveland Clinic Prospective TLE Registry. A total of 885 ICD leads (median implant duration 8 years) in 810 patients were included. Complete ICD TLE success was achieved in 97.2% of the leads (n = 860) and in 98.0% of the patients (n = 794). Major complications occurred in 22 patients (2.7%). Complete procedural success rate varied by manufacturer and lead family; Medtronic 98.9%, Abbott 95.9%, Boston Scientific 95.0%, Biotronik 91.2%, P = 0.03, and Linox family leads had the lowest, 89.7% P = 0.02. Multivariable predictors of incomplete ICD lead removal included ICD lead age > 10 years and Linox family lead. Multivariable predictors of major complications included ICD lead age > 15 years and longer lead extraction time, and predictors of all-cause mortality within 30 days included lead extraction for infection, end-stage renal disease, and higher New York Heart Association functional class., Conclusion: Complete and safe ICD lead removal rate by TLE is extremely high but varied by manufacturer and lead family. Linox family lead and >10 years lead age were independent predictors of incomplete lead removal., Competing Interests: Conflict of interest: K.H., A.Y., B.B., S.N., and C.T. have nothing to declare. T.C. has received consultancy fees from Philips and Biotronik. J.R. has received research grants from Abbott and Boston Scientific. D.M. has received consultancy fees from Medtronic. B.L.W. has received research grants and/or consultancy fees from Abbott, Boston Scientific, Medtronic, Biotronik, Philips, Cook, Convatec, and Xcardia., (© The Author(s) 2023. Published by Oxford University Press on behalf of the European Society of Cardiology.)
- Published
- 2023
- Full Text
- View/download PDF
18. Safety of same-day discharge after lead extraction procedures.
- Author
-
Dagher L, Tfaily MA, Vavuranakis M, Bhatia NK, Westerman SB, Shah AD, Lloyd MS, Leal M, De Lurgio DB, Merchant A, Panagopoulos A, Patel AM, Tompkins C, Leon AR, Merchant FM, and El-Chami MF
- Subjects
- Humans, Retrospective Studies, Treatment Outcome, Device Removal adverse effects, Device Removal methods, Patient Discharge, Defibrillators, Implantable adverse effects
- Abstract
Background: Same-day discharge (SDD) after cardiovascular procedures is rapidly gaining ground., Objective: We sought to evaluate the safety of SDD after transvenous lead extraction (TLE)., Methods: We performed a retrospective chart review of patients who underwent elective TLE between January 2020 and October 2021 at our institution. The primary outcome was SDD, and major procedural complications and readmissions within 30 days of the procedure were secondary outcomes., Results: In this analysis of 111 patients who underwent elective TLE, 80 patients (72%) were discharged on the same day (SDD group) while 31 patients (28%) stayed overnight (overnight group). Lead malfunction was the most common indication for TLE in both groups. Patients in the overnight group were more likely to have a lead dwell time of ≤10 years than those in the SDD group (38.7% vs 20% of all leads in each group; P = .042), have laser sheaths used for extraction and a higher number of leads extracted. No major complications were reported in both groups. In a multivariate analysis, lower body mass index and the use of laser sheath during TLE were predictors of overnight stay. Patients who underwent a procedure using advanced extraction techniques were 3.5 times more likely to stay overnight (95% confidence interval 1.27-9.78; P = .016)., Conclusion: In appropriately selected patients undergoing elective lead extraction, SDD is feasible and safe. Higher body mass index, fewer extracted leads, shorter lead dwell times (<10 years), and less frequent use of laser-powered extraction sheaths were associated with an increased likelihood of SDD., (Copyright © 2023 Heart Rhythm Society. Published by Elsevier Inc. All rights reserved.)
- Published
- 2023
- Full Text
- View/download PDF
19. [Lead extraction in cardiac implantable electronic devices].
- Author
-
Reinhardt A, Jansen H, Althoff T, Estner H, Iden L, Busch S, Rillig A, Johnson V, Sommer P, Tilz RR, Steven D, and Duncker D
- Subjects
- Humans, Treatment Outcome, Device Removal adverse effects, Device Removal methods, Retrospective Studies, Defibrillators, Implantable adverse effects, Pacemaker, Artificial adverse effects
- Abstract
Lead extraction due to infection or lead dysfunction has become more important in recent years. Patients with high risk of severe and life-threatening complications should only undergo surgery in experienced centers where appropriate personnel and equipment are available. In this review, different techniques and methods to safely and successfully perform transvenous lead extraction are summarized., (© 2023. The Author(s), under exclusive licence to Springer Medizin Verlag GmbH, ein Teil von Springer Nature.)
- Published
- 2023
- Full Text
- View/download PDF
20. Transvenous lead extraction: Experience of the Tandem approach.
- Author
-
Akhtar Z, Kontogiannis C, Elbatran AI, Leung LWM, Starck CT, Zuberi Z, Sohal M, and Gallagher MM
- Subjects
- Humans, Device Removal adverse effects, Device Removal methods, Time Factors, Fluoroscopy, Treatment Outcome, Retrospective Studies, Defibrillators, Implantable adverse effects, Pacemaker, Artificial adverse effects
- Abstract
Aims: Transvenous lead extraction (TLE) is important in the management of cardiac implantable electronic devices but carries risk. It is most commonly completed from the superior access, often with 'bail-out' support via the femoral approach. Superior and inferior access may be used in tandem, which has been proposed as an advance in safety and efficacy. The aim of this study is to evaluate the safety and efficacy of the Tandem approach., Method: The 'Tandem' procedure entailed grasping of the targeted lead in the right atrium to provide countertraction as a rotational dissecting sheath was advanced over the lead from the subclavian access. Consecutive 'Tandem' procedures performed by a single operator between December 2020 and March 2023 in a single large-volume TLE centre were included and compared with the conventional superior approach (control) using 1:1 propensity score matching; patients were statistically matched for demographics., Results: The Tandem in comparison with the conventional approach extracted leads of much greater dwell time (148.9 ± 79 vs. 108.6 ± 77 months, P < 0.01) in a shorter procedure duration (96 ± 36 vs. 127 ± 67 min, P < 0.01) but requiring more fluoroscopy (16.4 ± 10.9 vs. 10.8 ± 14.9 min, P < 0.01). The Tandem and control groups had similar clinical (100% vs. 94.7%, P = 0.07) and complete (94.8% vs. 92.8%, P = 0.42) success, with comparable minor (4% vs. 6.7%, P = 0.72) and major (0% vs. 4%, P = 0.25) complications; procedural (0% vs. 1.3%, P = 1) and 30-day (1.3% vs. 4%, P = 0.62) mortality were also similar., Conclusion: The Tandem procedure is as safe and effective as the conventional TLE. It can be applied to leads of a long dwell time with a potentially shorter procedure duration., Competing Interests: Conflict of interest: M.M.G. has received research funding from Medtronic and Attune Medical; has acted as a consultant and paid speaker for Adagio, Biosense Webster, and Cook Medical; and received workshop fee from Cook Medical. C.T.S. has received consulting fees and travel expenses from Medtronic; consulting fees and research support from Biotronik; research support from Abbott; workshop fees, consulting fees, educational grants, and research support from Cook Medical; consulting fees from Spectranetics/Philipps; and consulting fees from AngioDynamics. M.S. has received research funding from Abbott Medical and workshop fee from Cook Medical. Z.A. has received workshop fee from Cook Medical. The other authors have no conflicts of interest to declare., (© The Author(s) 2023. Published by Oxford University Press on behalf of the European Society of Cardiology.)
- Published
- 2023
- Full Text
- View/download PDF
21. Comparison of non-laser and laser transvenous lead extraction: a systematic review and meta-analysis.
- Author
-
Akhtar Z, Kontogiannis C, Georgiopoulos G, Starck CT, Leung LWM, Lee SY, Lee BK, Seshasai SRK, Sohal M, and Gallagher MM
- Subjects
- Humans, Vena Cava, Superior surgery, Device Removal adverse effects, Device Removal methods, Lasers, Cardiac Catheterization, Treatment Outcome, Retrospective Studies, Defibrillators, Implantable adverse effects, Pacemaker, Artificial adverse effects
- Abstract
Aims: Transvenous lead extraction (TLE) is performed using non-laser and laser techniques with overall high efficacy and safety. Variation in outcomes between the two approaches does exist with limited comparative evidence in the literature. We sought to compare non-laser and laser TLE in a meta-analysis., Methods and Results: We searched Medline, Embase, Scopus, ClinicalTrials.gov, and CENTRAL databases for TLE studies published between 1991 and 2021. From the included 68 studies, safety and efficacy data were carefully evaluated and extracted. Aggregated cases of outcomes were used to calculate odds ratio (OR), and pooled rates were synthesized from eligible studies to compare non-laser and laser techniques. Subgroup comparison of rotational tool and laser extraction was also performed. Non-laser in comparison with laser had lower procedural mortality (pooled rate 0% vs. 0.1%, P < 0.01), major complications (pooled rate 0.7% vs. 1.7%, P < 0.01), and superior vena cava (SVC) injury (pooled rate 0% vs. 0.5%, P < 0.001), with higher complete success (pooled rate 96.5% vs. 93.8%, P < 0.01). Non-laser comparatively to laser was more likely to achieve clinical [OR 2.16 (1.77-2.63), P < 0.01] and complete [OR 1.87 (1.69-2.08), P < 0.01] success, with a lower procedural mortality risk [OR 1.6 (1.02-2.5), P < 0.05]. In the subgroup analysis, rotational tool compared with laser achieved greater complete success (pooled rate 97.4% vs. 95%, P < 0.01) with lower SVC injury (pooled rate 0% vs. 0.7%, P < 0.01)., Conclusion: Non-laser TLE is associated with a better safety and efficacy profile when compared with laser methods. There is a greater risk of SVC injury associated with laser sheath extraction., Competing Interests: Conflict of interest: M.G. has received research funding from Attune Medical and workshop fee from Cook Medical and has acted as a consultant and a paid speaker for Biosense Webster, Cook Medical, and Adagio. C.T.S. has received consulting fees and travel expenses from Medtronic; consulting fees and research support from Biotronik; research support from Abbott; workshop fees, consulting fees, educational grants, and research support from Cook Medical; consulting fees from Spectranetics/Philipps; and consulting fees from AngioDynamics. M.S. has received research funding from Abbott and workshop fee from Cook Medical. Z.A. has received a workshop fee from Cook Medical. All remainder authors have declared no conflicts of interest., (© The Author(s) 2023. Published by Oxford University Press on behalf of the European Society of Cardiology.)
- Published
- 2023
- Full Text
- View/download PDF
22. Octogenarian patients and laser-assisted lead extraction: Should we put a limit?
- Author
-
Al-Maisary S, Romano G, Karck M, De Simone R, Kremer J, and Arif R
- Subjects
- Aged, 80 and over, Humans, Aged, Retrospective Studies, Octogenarians, Vena Cava, Superior, Lasers, Device Removal methods, Treatment Outcome, Defibrillators, Implantable adverse effects, Atrial Fibrillation etiology, Pacemaker, Artificial adverse effects
- Abstract
Background: Transvenous laser lead extraction (TLE) for cardiac implantable electric devices (CIED) is a challenging procedure especially if performed in octogenarians. In this study we evaluated the safety and efficacy of transvenous laser lead extraction in elderly patients., Methods: This is a retrospective study of octogenarian patients who underwent laser-assisted lead extraction (LLE) (GlideLight laser sheath, Philips, San Diego, USA). 270 Consecutive patients were included. Patients were divided into two groups. Octogenarian group and non-octogenarian group. The Data was gathered from patients treated between September 2013 and January 2020 and is retrospectively analyzed., Results: Of 270 consecutive patients, 38 (14.0%) were 80 years old or more. The total number of the extracted leads was 556 among which 84(15.0%) from the Octogenarian group. From these leads were 155 single coil leads, 82 dual coil leads, 129 right ventricular pacing leads, 155 right atrial leads, and 35 left ventricular leads. In the Octogenarian group the number of removed leads was as follows: 13 single coil leads, 10 dual coil leads, 28 right ventricular pacing leads, 28 right atrial leads and 5 left ventricular leads. No mortality was recorded in the Octogenarian group. One patient in the YG suffered from a superior vena cava tear and one patient suffered from pulmonary embolism., Conclusion: In octogenarian laser assisted lead extraction patients is a safe and effective procedure. No increase in morbidity, mortality or perioperative complication could be recorded in this group. Age should not be a limiting factor to perform this procedure., Competing Interests: The authors have declared that no competing interests exist., (Copyright: © 2023 Al-Maisary et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.)
- Published
- 2023
- Full Text
- View/download PDF
23. Transvenous Lead Extraction: Outcomes From a Single Centre Providing a National Service for New Zealand.
- Author
-
Whearty L, Lever N, and Martin A
- Subjects
- Female, Humans, Male, Middle Aged, Cohort Studies, Device Removal methods, New Zealand epidemiology, Retrospective Studies, Treatment Outcome, Aged, Defibrillators, Implantable, Pacemaker, Artificial
- Abstract
Background: With increasing demand for cardiac implantable electronic devices there is a parallel increase in the need for transvenous lead extraction (TLE). Due to its small population, all TLE procedures in New Zealand are currently performed in a single centre, Auckland City Hospital. We analysed the clinical characteristics and outcomes of those undergoing TLE since this service was established., Methods: We performed a retrospective, single-centre cohort study of all TLE procedures between October 2015 and December 2021. Definitions from the European Lead Extraction Controlled study, Heart Rhythm Society, European Heart Rhythm Association consensus documents were used., Results: A total of 247 patients had 480 leads extracted, averaging 40 TLE procedures annually. Patients had a median lead dwell time of 6 (interquartile range [IQR] 3-11) years, 60 (13%) of leads had been in-situ >15 years, median age 61 (IQR 48-70) years, 73 (30%) female, 28 (11%) Māori, 23 (9%) Pasifika. Lead dysfunction (115 patients, 47%) and infection (90 patients, 37%) were the most common indications for TLE. Complete clinical and radiological success was achieved for 96% and 95%, respectively. Procedure-related complications occurred in 16 (7%) patients. Major intra-procedure complications occurred in 5 patients (2%), including 2 (1%) deaths. Death within one year of TLE occurred in 13 (26%) with systemic infection, 5 (3%) with local infection, and 5 (3%) with non-infection indications for TLE, p <0.01., Conclusions: TLE is associated with high radiographic and clinical success, low complication, and low mortality rate. At our single centre providing a national service, TLE outcomes are comparable with those achieved internationally., Competing Interests: Conflict of Interest The Authors declare that there is no conflict of interest., (Copyright © 2023 Australian and New Zealand Society of Cardiac and Thoracic Surgeons (ANZSCTS) and the Cardiac Society of Australia and New Zealand (CSANZ). Published by Elsevier B.V. All rights reserved.)
- Published
- 2023
- Full Text
- View/download PDF
24. Timing and mid-term outcomes of using leadless pacemakers as replacement for infected cardiac implantable electronic devices.
- Author
-
Breeman KTN, Beurskens NEG, Driessen AHG, Wilde AAM, Tjong FVY, and Knops RE
- Subjects
- Humans, Aged, Aged, 80 and over, Lipopolysaccharides, Treatment Outcome, Device Removal methods, Replantation, Retrospective Studies, Defibrillators, Implantable, Pacemaker, Artificial, Endocarditis, Prosthesis-Related Infections epidemiology
- Abstract
Background: Cardiac implantable electronic device (CIED) infections have a high morbidity and mortality and are an indication of device extraction. As a replacement, leadless pacemakers (LPs) may be preferable due to a low infection risk, but mid-term data on reinfections is lacking. Moreover, early LP reimplantation in pacemaker-dependent patients would circumvent the need for temporary pacemakers., Methods: We included all patients with LP implantation as a replacement for an infected CIED, between January 2013 and December 2021. The occurrence of reinfection was assessed during standard follow-up visits., Results: Twenty-nine patients (mean age 81 ± 9 years) were included, of which 21 (73%) had a pocket infection, 7 (24%) endocarditis, and 1 (3%) a systemic infection without endocarditis. All LP implantations were successful. LPs were implanted before extraction (n = 4, 13%), simultaneously with extraction (n = 5, 17%) and after extraction (n = 20, 70%). No reinfection occurred during the follow-up of median 32 months (IQR 13-66 months). Repeat blood cultures obtained in 9 (30%) patients and transthoracic echocardiography in all 7 patients with pacemaker endocarditis were negative for reinfection. In a subset of 6 LPs extracted during follow-up due to early battery depletion, prophylactically after the battery advisory or due to non-capture (median 36 months (range 0-67 months) post-implantation), histopathologic examination of tissues around the LPs showed no signs of infection., Conclusions: After replacing infected CIEDs for an LP, no reinfections occurred in over 2.5 years follow-up. These results confirm that in case of CIED infection, the LP is an appealing replacement device. LP implantation before CIED extraction is feasible., (© 2022. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.)
- Published
- 2023
- Full Text
- View/download PDF
25. Radiographic predictors of failure of simple manual traction of transvenous implantable cardioverter-defibrillator leads: a single-center experience.
- Author
-
Celikyurt U, Acar B, Torun A, Karakullukcu M, Cakir O, Baris O, Vural A, and Agacdiken A
- Subjects
- Humans, Retrospective Studies, Traction, Fibrosis, Device Removal methods, Defibrillators, Implantable
- Abstract
Background: Extraction of the implantable cardioverter-defibrillator (ICD) leads could be a difficult procedure due to fibrous tissue around the lead and anatomical variations. In this report, we present our experience in the radiographic predictors of failure of simple manual traction (SMT) in patients with dual-coil ICD requiring lead extraction (LE)., Methods: Between January 2017 and February 2021, 103 leads were removed in 65 consecutive patients; 65 (63.1%) were dual-coil ICD leads, 22 (21.4%) were atrial, and 16 (15.5%) were coronary sinus leads. Patient-based and procedural data were collected and analyzed retrospectively. Clinical and procedural characteristics were compared and radiographic predictors of failure of SMT of ICD leads were assessed. Projected anteroposterior (AP) lead tortuosity was measured and lead slack score was estimated on chest X-ray (CXR)., Results: Simple manual traction failed in 27 (42%) of the ICD leads. Ottawa slack score (odds ratio [OR] 2.368, 95% CI [1.261-4.447]; P = 0.007), AP lead tortuosity > 1.10 (OR 7.477, 95% CI [1.718-35.542]; P = 0.007), and number of previous interventions (OR 6.016, 95% CI [1.184-30.557]; P < 0.030) were found to be independently related to the failure of SMT. Receiver-operator characteristic curve analysis yielded an AP lead tortuosity cutoff value of > 1.10 for predicting the failure of SMT. The area under the curve was 0.744; the 95% confidence interval (CI) was 0.617 to 0.871 (P = 0.001), with a sensitivity of 63% and a specificity of 73%., Conclusion: Simple manual traction success in our study varied based on radiographic lead-related parameters. Before planning the procedure, increased AP lead tortuosity in vasculature and higher lead slack score can be easily determined on CXR and may be associated with more fibrous adherences, the complexity of the LE, and failure of SMT., (© 2022. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.)
- Published
- 2023
- Full Text
- View/download PDF
26. Single center experience with the novel rotating dilator sheath TightRail TM Sub-C in transvenous lead extraction.
- Author
-
Frei C, Hofer D, Jan S, Grebmer C, and Breitenstein A
- Subjects
- Humans, Retrospective Studies, Device Removal methods, Equipment Design, Equipment Failure, Treatment Outcome, Defibrillators, Implantable, Pacemaker, Artificial
- Abstract
Introduction: Transvenous lead extraction has become a frequent procedure in the context of device lead management and various tools are available. The aim of this study was to investigate the efficacy and safety of the novel short rotating dilator sheath TightRail
TM Sub-C (Sub-C) in transvenous lead extraction., Methods: For this retrospective single-center analysis, we included consecutive patients undergoing transvenous lead extraction using the Sub-C from January 2018 until February 2020 at the University Heart Center Zurich., Results: A total of 87 leads were extracted within 45 patients using the Sub-C extraction sheath. The mean dwell time of the leads was 112 ± 9.1 months. Complete procedural success was achieved in 95.6% (43/45) and clinical procedural success in 97.8% (44/45). Two major complications (4.4%, 2/45) occurred, but neither was directly related to the Sub-C., Conclusion: This retrospective single-center analysis suggests that transvenous lead extraction with a routine use of the TightRailTM Sub-C extraction sheath is a safe strategy resulting in high success rates that may offer useful theoretical benefits. Future studies are needed to evaluate the incremental benefit of a routine use of short extraction sheaths including the Sub-C during TLE procedures., (© 2023 Wiley Periodicals LLC.)- Published
- 2023
- Full Text
- View/download PDF
27. Utility of a multipurpose catheter for transvenous extraction of old broken leads: A novel technique for fragile leads.
- Author
-
Okada A, Higuchi S, Shoda M, Tabata H, Kataoka S, Shoin W, Kobayashi H, Okano T, Yoshie K, Kato K, Saigusa T, Ebisawa S, Motoki H, and Kuwahara K
- Subjects
- Humans, Electrodes, Implanted adverse effects, Retrospective Studies, Polypropylenes, Device Removal methods, Catheters, Treatment Outcome, Pacemaker, Artificial adverse effects, Defibrillators, Implantable
- Abstract
Background: Transvenous lead extraction has been possible since the 1980s. However, complications during lead extraction, such as the distal end fragment of the lead remaining in the myocardium or venous system and injury to the veins or heart, have been reported., Objective: The purpose of this study was to examine our method for complete removal of a separated lead, as extraction of long-term implanted devices is difficult using standard methods and may require additional procedures. The removal of leads with inner conductor coil and lead tip separated from outer insulation, conductor coil, and proximal ring electrode using a multipurpose catheter is reported., Methods: In total, 345 consecutive patients who underwent transvenous lead extraction (TLE) from April 2014 to March 2021 were retrospectively analyzed. Lead characteristics, device type, and indications for extraction were further analyzed in 20 patients who developed separation of the proximal ring electrode and outer conductor coil from the inner conductor and distal tip at the time of extraction., Results: Extractions were performed using an excimer laser sheath laser and a Byrd polypropylene telescoping sheath (n = 15); laser, Byrd polypropylene telescoping sheath, and Evolution RL (n = 2); laser and Evolution RL (n = 3); Byrd polypropylene telescoping sheath and Evolution RL (n = 1); Byrd polypropylene telescoping sheath only (n = 4); and Evolution RL only (n = 2). Twenty-seven leads implanted for more than 10 years had lead separation. A multipurpose catheter was used to protect the fragile leads from further damage. All leads were completely extracted., Conclusion: All distal tip-to-proximal ring electrode separated leads were successfully removed using laser and other sheaths with the assistance of a multipurpose catheter, without any part of the leads remaining in the heart., (Copyright © 2023 Heart Rhythm Society. Published by Elsevier Inc. All rights reserved.)
- Published
- 2023
- Full Text
- View/download PDF
28. Superior vena cava tear during transvenous lead extraction: Medical management in hemodynamically stable patients.
- Author
-
Domain G, Strubé C, Jacques F, Marzouk M, Dumont É, Villeneuve J, Plourde B, Albert G, Sarrazin JF, Steinberg C, and Philippon F
- Subjects
- Male, Humans, Middle Aged, Adult, Vena Cava, Superior surgery, Heart Atria surgery, Hematoma, Device Removal methods, Pacemaker, Artificial adverse effects, Defibrillators, Implantable adverse effects
- Abstract
Introduction: Superior vena cava (SVC) tear is the most lethal complication during transvenous lead extraction (TLE) with a mortality rate as high as 50%. Treatment involves aggressive attempts to maintain cardiac output and immediate sternotomy to localize and repair the vascular tear. Occlusion balloons have been developed to provisionally occlude the lacerated SVC and to provide hemodynamic stability allowing time for surgery. In case of mediastinal hematoma without hemodynamic instability, the strategy remains unclear., Methods and Results: We describe two cases of SVC tear during TLE. The first case was a 60-year-old man who presented with a right ventricular single-chamber defibrillator lead fracture and innominate vein stenosis. The RV lead was removed using a laser sheath causing a mediastinal hematoma with no active bleeding during surgical exploration few hours later. The second case was a 28-year-old man that presented with a right atrial (RA) lead fracture and RV lead insulation failure in a dual-chamber defibrillator (ICD)., Conclusion: Both the RA and RV leads were removed with mechanical sheaths, and a mediastinal hematoma was medically managed., (© 2023 The Authors. Pacing and Clinical Electrophysiology published by Wiley Periodicals LLC.)
- Published
- 2023
- Full Text
- View/download PDF
29. Regional Disparities in Transvenous Lead Extraction for Cardiac Implantable Electronic Device Infection in Japan - A Descriptive Study Using the National Database Open Data.
- Author
-
Togashi S, Isawa T, Honda T, Furuya K, Yamaya K, Taguri M, and Toyoda S
- Subjects
- Aged, 80 and over, Humans, Device Removal methods, Japan epidemiology, Retrospective Studies, Treatment Outcome, Defibrillators, Implantable adverse effects, Heart Diseases, Pacemaker, Artificial adverse effects
- Abstract
Background: Because the penetration of transvenous lead extraction (TLE) for cardiac implantable electronic device (CIED) infection has not been investigated in Japan, we conducted a population-based, retrospective, descriptive study to evaluate regional disparities in the use of TLE for CIED infection and the potential undertreatment of CIED infection using a nationwide insurance claims database., Methods and results: Patients who underwent CIED implantation or generator exchange and TLE between April 2018 and March 2020 were identified. Moreover, the penetration ratio of TLE for CIED infection in each prefecture was estimated. CIED implantation and TLE were most prevalent in the age categories of 80-89 years (40.3%) and 80-89 years (36.9%), respectively. There was no correlation between the number of CIED implantations and that of TLE (rho=-0.087, 95% confidence interval -0.374 to 0.211, P=0.56). The median penetration ratio was 0.00 (interquartile range 0.00-1.29). Of the 47 prefectures, 6, comprising Okinawa, Miyagi, Okayama, Fukuoka, Tokyo, and Osaka, showed a penetration ratio ≥2.00., Conclusions: Our study data indicated great regional disparities in the penetration of TLE and potential undertreatment of CIED infection in Japan. Additional measures are needed to address these issues.
- Published
- 2023
- Full Text
- View/download PDF
30. Transvenous Lead Extraction in Pediatric Patients - Is It the Same Procedure in Children as in Adults?
- Author
-
Kutarski A, Miszczak-Knecht M, Brzezinska M, Birbach M, Lipiński W, Polewczyk AM, Jacheć W, Polewczyk A, Tułecki Ł, Tomków K, Stefańczyk P, Nowosielecka D, and Bieganowska K
- Subjects
- Humans, Adult, Child, Adolescent, Device Removal methods, Risk Factors, Heart, Treatment Outcome, Retrospective Studies, Defibrillators, Implantable adverse effects, Pacemaker, Artificial adverse effects
- Abstract
Background: Cardiac implantable electronic devices (CIED) are very rare in the pediatric population. In children with CIED, transvenous lead extraction (TLE) is often necessary. The course and effects of TLE in children are different than in adults. Thus, this study determined the differences and specific characteristics of TLE in children vs. adults., Methods and results: A post hoc analysis of TLE data in 63 children (age ≤18 years) and 2,659 adults (age ≥40 years) was performed. The 2 groups were compared with respect to risk factors, procedure complexity, and effectiveness. In children, the predominant pacing mode was a single chamber ventricular system and lead dysfunction was the main indication for lead extraction. The mean implant duration before TLE was longer in children (P=0.03), but the dwell time of the oldest extracted lead did not differ significantly between adults and children. The duration (P=0.006) and mean extraction time per lead (P<0.001) were longer in children, with more technical difficulties during TLE in the pediatric group (P<0.001). Major complications were more common, albeit not significantly, in children. Complete radiographic and procedural success were significantly lower in children (P<0.001)., Conclusions: TLE in children is frequently more complex, time consuming, and arduous, and procedural success is more often lower. This is related to the formation of strong fibrous tissue surrounding the leads in pediatric patients.
- Published
- 2023
- Full Text
- View/download PDF
31. Prevalence, management, and prediction of venous access site occlusion in patients undergoing lead revision surgery.
- Author
-
Kellnar A, Fichtner S, Reitinger P, Sadoni S, Heyn O, Sams L, Estner HL, and Lackermair K
- Subjects
- Humans, Male, Female, Retrospective Studies, Reoperation methods, Prevalence, Treatment Outcome, Device Removal methods, Defibrillators, Implantable adverse effects, Vascular Diseases, Pacemaker, Artificial
- Abstract
Background: Implantable electronic cardiac devices (CIED) have emerged as an essential component in the treatment of cardiac arrhythmias and heart failure. Due to increased life expectancy, expanding indications and limited technical survival, an increasing number of revision procedures can be anticipated. Venous access site occlusion (VASO) is the main obstacle during revision surgery. In this retrospective study we evaluated the prevalence, predictive parameters and operative management of venous access site occlusion., Methods and Results: Between 01/2016 and 12/2020 304 patients underwent lead revision surgery of transvenous CIED in our department. Prevalence of VASO was 25.7% (n = 78), one patient was symptomatic. Independent predicting clinical parameters were male sex (2.86 (1.39-5.87), p < 0.01) and lead age (1.11 (1.05-1.18), p < 0.01)). Revision surgery despite VASO was successful in 97.4% (n = 76) without prolongation of the total surgery time or higher complication rates. Yet, lead extraction was possible in 92% of patients with VASO vs. 98.2% of patients without VASO (p 0.01)., Conclusion: VASO is a frequent condition in patients undergoing lead revision surgery, but successful revision is feasible in most cases without preceding lead extraction. However, the lower success rates of lead extractions may be prognostically relevant, especially for younger patients., Competing Interests: Declaration of Competing Interest This research did not receive any specific grant from funding agencies in the public, commercial, or not-for-profit sectors. The authors have no conflicts of interest to disclose. The data underlying this article will be shared anonymised on reasonable request to the corresponding author., (Copyright © 2023 Elsevier B.V. All rights reserved.)
- Published
- 2023
- Full Text
- View/download PDF
32. Reimplantation and long-term mortality after transvenous lead extraction in a high-risk, single-center cohort.
- Author
-
Zsigmond EJ, Miklos M, Vida A, Benak A, Makai A, Schvartz N, Klausz G, Hegedus Z, Bogats G, Saghy L, and Vamos M
- Subjects
- Humans, Middle Aged, Aged, Aged, 80 and over, Retrospective Studies, Arrhythmias, Cardiac therapy, Survival Rate, Device Removal methods, Treatment Outcome, Defibrillators, Implantable, Pacemaker, Artificial
- Abstract
Purpose: The use of cardiac implantable electronic devices (CIEDs) has increased significantly over the last decades. With the development of transvenous lead extraction (TLE), procedural success rates also improved; however, data regarding long-term outcomes are still limited. The aim of our study was to analyze the outcomes after TLE, including reimplantation data, all-cause and cause-specific mortality., Methods: Data from consecutive patients undergoing TLE in our institution between 2012 and 2020 were retrospectively analyzed. Periprocedural, 30-day, long-term, and cause-specific mortalities were calculated. We examined the original and the revised CIED indications and survival rate of patients with or without reimplantation., Results: A total of 150 patients (age 66 ± 14 years) with 308 leads (dwelling time 7.8 ± 6.3 years) underwent TLE due to pocket infection (n = 105, 70%), endocarditis (n = 35, 23%), or non-infectious indications (n = 10, 7%). All-cause mortality data were available for all patients, detailed reimplantation data in 98 cases. Procedural death rate was 2% (n = 3), 30-day mortality rate 2.6% (n = 4). During the 3.5 ± 2.4 years of follow-up, 44 patients died. Arrhythmia, as the direct cause of death, was absent. Cardiovascular cause was responsible for mortality in 25%. There was no significant survival difference between groups with or without reimplantation (p = 0.136)., Conclusions: Despite the high number of pocket and systemic infection and long dwelling times in our cohort, the short- and long-term mortality after TLE proved to be favorable. Moreover, survival without a new device was not worse compared to patients who underwent a reimplantation procedure. Our study underlines the importance of individual reassessment of the original CIED indication, to avoid unnecessary reimplantation., (© 2021. Springer Science+Business Media, LLC, part of Springer Nature.)
- Published
- 2023
- Full Text
- View/download PDF
33. [Pacemaker infection in fragile patients].
- Author
-
Casorelli E, Pescatori I, Ruocco G, Bonnemeier H, Assadian O, and Bui F
- Subjects
- Humans, Device Removal adverse effects, Device Removal methods, Retrospective Studies, Defibrillators, Implantable adverse effects, Pacemaker, Artificial adverse effects, Heart Diseases therapy, Prosthesis-Related Infections diagnosis, Prosthesis-Related Infections etiology, Prosthesis-Related Infections surgery
- Abstract
Complications associated with cardiac implantable electric devices (CIED) are manifold. They include lead dislocation, twiddler's syndrome, device malfunction, haematoma formation and infection. Infections can be divided into acute, subacute and late infections. Both the time of onset and the route of infection play a crucial role. The consequences of a CIED infection are devastating. The most modern treatment methods include the removal of all implanted implants. If complete removal is not followed in the event of infection, there is a high rate of infection recurrence. Open thoracic surgery to remove infected CIED hardware has been replaced by percutaneous lead extraction procedures. Lead extraction requires specialised equipment and expertise and may not be readily available or feasible for some patients. Each extraction procedure is associated with a small risk of potentially fatal complications (e.g. cardiac avulsion, vascular avulsion, haemothorax and cardiac tamponade). For these reasons, the performance of such procedures should be limited to centres with adequate equipment and experience. Successful salvage of CIED systems with in situ sterilisation of contaminated hardware has been reported. In our case, we report the successful salvage of an exposed generator in a frail patient treated more than 5 years after the last generator replacement., (© 2023. The Author(s).)
- Published
- 2023
- Full Text
- View/download PDF
34. Mechanical extraction of implantable cardioverter-defibrillator leads with a dwell time of more than 10 years: insights from a single high-volume centre.
- Author
-
Ząbek A, Boczar K, Ulman M, Holcman K, Kostkiewicz M, Pfitzner R, Dębski M, Musiał R, Lelakowski J, and Małecka B
- Subjects
- Humans, Device Removal adverse effects, Device Removal methods, Treatment Outcome, Retrospective Studies, Defibrillators, Implantable adverse effects, Pacemaker, Artificial
- Abstract
Aims: To analyze and compare the effectiveness and safety of transvenous lead extraction (TLE) of implantable cardioverter-defibrillator (ICD) leads with a dwell time of >10 years (Group A) vs. younger leads (Group B) using mechanical extraction systems., Methods and Results: Between October 2011 and July 2022, we performed TLE in 318 patients. Forty-six (14.4%) extracted ICD leads in 46 (14.5%) patients that had been implanted for >10 years. The median dwell time of all extracted ICD leads was 5.9 years. Cardiovascular implantable electronic device-related infection was an indication for TLE in 31.8% of patients. Complete ICD leads removal and complete procedural success in both groups were similar (95.7% in Group A vs. 99.6% in Group B, P = 0.056% and 95.6% in Group A vs. 99.6% in Group B, P = 0.056, respectively). We did not find a significant difference between major and minor complication rates in both groups (6.5% in Group A vs. 1.5% in Group B and 2.2% in Group A vs. 1.8% in Group B, P = 0.082, respectively). One death associated with the TLE procedure was recorded in Group B., Conclusion: The TLE procedures involving the extraction of old ICD leads were effective and safe. The outcomes of ICD lead removal with a dwell time of >10 years did not differ significantly compared with younger ICD leads. However, extraction of older ICD leads required more frequent necessity for utilizing multiple extraction tools, more experience and versatility of the operator, and increased surgery costs., Competing Interests: Conflict of interest: The authors have no conflict of interest., (© The Author(s) 2023. Published by Oxford University Press on behalf of the European Society of Cardiology.)
- Published
- 2023
- Full Text
- View/download PDF
35. Efficacy and safety of the extraction of cardiostimulation leads using a mechanical dissection tool. A single center experience.
- Author
-
Villegas EG, Juárez Del Río JI, Carmona JCR, Valdíris UR, Peinado ÁA, and Peinado RP
- Subjects
- Humans, Retrospective Studies, Treatment Outcome, Device Removal methods, Defibrillators, Implantable, Pacemaker, Artificial
- Abstract
Background: The percutaneous extraction of endovascular cardiostimulation and defibrillation leads is the most frequent technique nowadays. The tools used today must guarantee the success of the procedure, with the minimum of complications. Our objective was to analyze the safety and efficacy of lead extraction using the Evolution mechanical dissection tool (Cook Medical, USA)., Methods: A retrospective study was carried out in a total of 826 consecutive patients from October 2009 to December 2018 who underwent the procedure with the Evolution mechanical dissection tool. Preoperative study included complete blood tests, echocardiogram, and chest X-ray. The procedures were performed in the operating room, under general anesthesia and echocardiographic control., Results: A total of 1227 leads were extracted with a mean chronicity of 10.3 ± 5.1 years. Clinical success (CS) rate was 99.7%. A total of 16 (1.9%) complications occurred, 2 (0.24%) were major complications and 14 (1.7%) were minor complications. There was no operative mortality. There was no statistically significant relationship between implant chamber and complete efficacy. The complete extraction was achieved in all left ventricular leads, in 762 of 774 (98.45%) of right ventricular lead removal, and in 330 of 334 (98.8%) of right atrial leads (p = .31)., Conclusion: In our experience, percutaneous extraction of intravenous leads via the use of the Evolution tool (Cook Medical, USA), is a very effective and safe technique that offers low morbidity and mortality., (© 2022 Wiley Periodicals LLC.)
- Published
- 2023
- Full Text
- View/download PDF
36. Outcomes of transvenous lead extraction of very old leads using bidirectional rotational mechanical sheaths: Results of a multicentre study.
- Author
-
Migliore F, Pittorru R, Dall'Aglio PB, De Lazzari M, Rovaris G, Piazzi E, Dentico A, Ferrieri A, D'Angelo G, Marzi A, Sawaf BE, Bertaglia E, Iliceto S, Gerosa G, Tarzia V, Carretta D, and Mazzone P
- Subjects
- Humans, Device Removal methods, Electrodes, Implanted, Retrospective Studies, Treatment Outcome, Defibrillators, Implantable, Pacemaker, Artificial
- Abstract
Introduction: Lead dwell time >10 years is a recognized predictor for transvenous lead extraction (TLE) failure and complications. Data on the efficacy and safety of TLE using the bidirectional rotational mechanical sheaths in patients with very old leads are lacking. In this multicenter study, we reported the outcomes of transvenous rotational mechanical lead extraction in patients with leads implanted for ≥10 years., Methods: A total of 441 leads (median: 159 months [135-197]; range: 120-487) in 189 consecutive patients were removed with the Evolution RL sheaths (Cook Medical, Bloomingtom, IN, USA) and mechanical ancillary tools supporting the procedures., Results: The main indication for TLE was infection in 74% of cases. Complete procedural success rate, clinical success rate, per lead were 94.8% and 98.2%, respectively. Failure of lead extraction was seen in 1.8% of leads. The additional use of a snare via the femoral approach was required in 9% of patients. Lead dwell time was the only predictor of incomplete led removal (odds ratio: 1.009; 95% confidence interval [CI]: 1.003-1.014; p = .002). Four major complication (2%) were encountered. During a mean time follow-up of 31 ± 27 months, 21 patients (11%) died. No procedure-related mortality occurred. Predictors of mortality included severe left ventricular systolic dysfunction (hazard ratio [HR]: 8.06; 95% CI: 2.99-21.73; p = .001), TLE for infection (HR: 8.0; 95% CI: 1.04-62.5; p = .045), diabetes (HR: 3.7; 95% CI: 1.48-9.5; p = .005), and previous systemic infection (HR: 3.1; 95% CI: 1.17-8.24; p = .022). Incomplete lead removal or failure lead extraction did not impact on survival during follow-up., Conclusion: Our findings demonstrated that the use of bidirectional rotational TLE mechanical sheaths combined with different mechanical tools and femoral approach allows reasonable success and safety in patients with very old leads at experienced specialized centers., (© 2022 Wiley Periodicals LLC.)
- Published
- 2023
- Full Text
- View/download PDF
37. A head-to-head comparison of laser vs. powered mechanical sheaths as first choice and second line extraction tools.
- Author
-
Zsigmond EJ, Saghy L, Benak A, Miklos M, Makai A, Hegedus Z, Alacs E, Agocs S, and Vamos M
- Subjects
- Humans, Middle Aged, Aged, Retrospective Studies, Treatment Outcome, Device Removal methods, Lasers, Defibrillators, Implantable, Pacemaker, Artificial
- Abstract
Aims: During transvenous lead extraction (TLE) longer dwelling time often requires the use of powered sheaths. This study aimed to compare outcomes with the laser and powered mechanical tools., Methods and Results: Single-centre data from consecutive patients undergoing TLE between 2012 and 2021 were retrospectively analysed. Efficacy and safety of the primary extraction tool were compared. Procedures requiring crossover between powered sheaths were also analysed. Moreover, we examined the efficacy of each level of the stepwise approach. Out of 166 patients, 142 (age 65.4 ± 13.7 years) underwent TLE requiring advanced techniques with 245 leads (dwelling time 9.4 ± 6.3 years). Laser sheaths were used in 64.9%, powered mechanical sheaths in 35.1% of the procedures as primary extraction tools. Procedural success rate was 85.5% with laser and 82.5% with mechanical sheaths (P = 0.552). Minor and major complications were observed in similar rate. Procedural mortality occurred only in the laser group in the case of three patients. Crossover was needed in 19.5% after laser and in 12.8% after mechanical extractions (P = 0.187). Among crossover procedures, only clinical success favoured the secondary mechanical arm (87.1 vs. 54.5%, aOR: 0.09, 95% CI: 0.01-0.79, P = 0.030). After step-by-step efficacy analysis, procedural success was 64.9% with the first-line extraction tool, 75.1% after crossover, 84.5% with bailout femoral snare, and 91.8% by non-emergency surgery., Conclusion: The efficacy and safety of laser and mechanical sheaths were similar, however in the subgroup of crossover procedures mechanical tools had better performance regarding clinical success. Device diversity seems to help improving outcomes, especially in the most complicated cases., Competing Interests: Conflict of interest: M.V. reports consulting fees and/or nonfinancial support from Biotronik, Medtronic, Minimal Invasive Technology Ltd., and Pfizer outside the submitted work. The other authors declare no conflict of interest., (© The Author(s) 2022. Published by Oxford University Press on behalf of the European Society of Cardiology.)
- Published
- 2023
- Full Text
- View/download PDF
38. Same-day discharge after transvenous lead extraction: feasibility and outcomes.
- Author
-
Atteya G, Alston M, Sweat A, Saleh M, Beldner S, Mitra R, Willner J, John RM, and Epstein LM
- Subjects
- Humans, Female, Middle Aged, Aged, Male, Patient Discharge, Feasibility Studies, Device Removal adverse effects, Device Removal methods, Retrospective Studies, Treatment Outcome, Cardiac Resynchronization Therapy, Defibrillators, Implantable adverse effects, Pacemaker, Artificial adverse effects
- Abstract
Aims: Same-day discharge (SDD) is safe for patients undergoing electrophysiology procedures. There is no existing data regarding SDD for patients undergoing transvenous lead extraction (TLE). We report our experience with SDD for patients undergoing TLE., Methods and Results: The study group included patients undergoing TLE between February 2020 and July 2021 without an infectious indication. A modified SDD protocol for device implants/ablations was applied to TLE patients. Patient characteristics, extraction details, outcomes, and complications were reviewed. Of 239 patients undergoing TLE, 210 were excluded (94 infections and 116 did not meet SDD criteria). Of the remaining 29 patients, seven stayed due to patient preference and 22 were discharged home the same day. The SDD group had an average age of 65.9 ± 12 (47-84), 41% female, and LVEF of 52.2 ± 18% (10-80). The indication for TLE was malfunction (20), upgrade (4), advisory lead (2), and magnetic resonance imaging compatibility (1). Extractions included four implantable cardioverter-defibrillators (ICDs), 17 pacemakers (PPM), and one cardiac resynchronization therapy (CRT)-P system. The leads were 9.6 years (1.5-21.7) old, and 1.8 leads were removed per patient (1-3); the lead extraction difficulty (LED) score was 11.6 ± 7. Twenty underwent cardiovascular implantable electronic device (CIED) re-implantation (2 ICD, 3 CRT-D, 13 PPM, and 2 CRT-P). For CIED re-implants, patients sent a remote transmission the next day, and all patients received a next-day call. There were no procedure or device-related issues, morbidities, or mortalities in the 30 days after discharge., Conclusion: Same-day discharge after TLE for non-infectious aetiologies is safe and feasible in a select group of patients with early procedure completion who meet strict SDD criteria., Competing Interests: Conflict of interest: L.M.E. is a speaker/consultant for Phillips, Medtronic. R.M.J. receives lecture honorarium from Abbot Inc. The rest of the authors have no conflict of interests., (© The Author(s) 2022. Published by Oxford University Press on behalf of the European Society of Cardiology.)
- Published
- 2023
- Full Text
- View/download PDF
39. AngioVac system guided removal of vegetations from pacemaker lead-related infective endocarditis.
- Author
-
Mahajan P, Aedma SK, Ally S, and Garg A
- Subjects
- Female, Humans, Device Removal methods, Endocarditis etiology, Endocarditis surgery, Endocarditis, Bacterial etiology, Endocarditis, Bacterial surgery, Pacemaker, Artificial adverse effects, Thrombosis therapy, Defibrillators, Implantable adverse effects, Prosthesis-Related Infections etiology, Prosthesis-Related Infections surgery
- Abstract
The AngioVac aspiration system is a catheter-based technique that has been used for removal of unwanted intravascular material in growing numbers of institutions around the world since 2013. It provides an alternative and a less invasive approach for the treatment of venous thromboembolism and intrinsic or cardiac implantable electronic devices (CIED)-related infective endocarditis. This system uses venous cannulas and extracorporeal filtering mechanisms to effectively remove thrombi or vegetations resulting in less invasion and minimal blood loss. We present a case of a woman in her mid-50s who underwent successful AngioVac-guided removal of lead vegetations followed by percutaneous CIED removal., Competing Interests: Competing interests: None declared., (© BMJ Publishing Group Limited 2023. No commercial re-use. See rights and permissions. Published by BMJ.)
- Published
- 2023
- Full Text
- View/download PDF
40. Predictors for adverse events during cardiac lead extraction - Experience from a large single centre.
- Author
-
Xiao Z, He J, Du A, Yang D, An Y, and Li X
- Subjects
- Humans, Male, Female, Aged, Device Removal adverse effects, Device Removal methods, Nomograms, Clinical Decision-Making, Retrospective Studies, Treatment Outcome, Defibrillators, Implantable adverse effects, Pacemaker, Artificial adverse effects
- Abstract
Background: As the use of cardiac implantable electronic devices (CIED) has increased in recent years, the need for transvenous lead extraction (TLE) has also steadily increased. However, the TLE procedure could lead to serious complications and even death. Clinical decision-making tools are necessary for predicting these adverse events, but the appropriate tools have not yet been developed., Objective: To explore the possible predictors and develop a clinical model to predict TLE related adverse events., Methods: All the patients who were admitted to our cardiac center for TLE from January 2014 to January 2021 were included in this study. The patient information, device baseline characteristics, procedure-related information, complications and outcomes were recorded. Independent predictors of TLE related adverse events were identified by univariate, LASSO and multivariate analysis. A nomogram for predicting these adverse events was developed based on these independent predictors. Calibration and decision curve analysis were conducted to evaluate the nomogram., Results: One thousand and one hundred patients were included in this study, 778 (70.7%) were male and the median age was 68 years old. A total of 2,208 leads were extracted and 2.01±0.74 leads were extracted per procedure. Fifty-five patients (5%) developed adverse events including minor complications (2.4%), major complications (2.3%) and death (0.27%). Seven independent predictors for TLE related adverse events were identified and selected to establish the nomogram including BMI, female gender, hypoalbuminemia, number of extracted leads>3, longest dwell time of the extracted leads and manual traction. The area under the receiver operating characteristic (ROC) curve (AUC) for the prediction model was 0.774. Calibration curve and decision curve analysis showed that the nomogram had good prediction performance., Conclusion: TLE related adverse events are some of the key issues that concern clinicians. We have identified seven independent factors and established a predictive model that may help clinicians identify at-risk patients and create better plans for lead extraction., Competing Interests: Declaration of Competing Interest The authors declare no conflicts of interest., (Copyright © 2022. Published by Elsevier B.V.)
- Published
- 2023
- Full Text
- View/download PDF
41. Surgical extraction of cardiac implantable electronic device leads based on a heart team approach.
- Author
-
Mizuno T, Goya M, Fujiwara T, Oishi K, Takeshita M, Yashima M, Nagaoka E, Oi K, and Sasano T
- Subjects
- Humans, Device Removal methods, Electronics, Retrospective Studies, Treatment Outcome, Vena Cava, Superior, Defibrillators, Implantable adverse effects, Pacemaker, Artificial adverse effects
- Abstract
Background: As cardiac implantable electronic devices, such as pacemakers, cardioverter defibrillators, and cardiac resynchronization therapies, have become more popular, device extraction has become more frequent. At our institution, individual treatment strategies are discussed at a heart team meeting. Transvenous lead extraction (TVLE) is a first-line treatment; however, surgical lead extraction (SLE) is sometimes selected as a primary choice to provide optimal treatment and maintain the medical safety policy. This study aimed to investigate the validity of this heart team decision-making., Methods: From 2013 to 2021, 384 consecutive patients underwent lead extraction at our institution., Results: SLE was proposed as the primary intervention for 21 patients who had high risk of bleeding, difficult TVLE conditions, large vegetations, and other concomitant cardiac diseases. Of the 363 TVLE patients, 10 patients required surgical intervention; 5 had TVLE difficulty followed by SLE and 5 had excessive bleeding. SLE was performed in 26 patients, 19 of whom required valve surgery, and 8 required plication of the great veins. In 4 of the 17 hybrid procedures with SLE and TVLE, excessive bleeding occurred due to laceration of the superior vena cava and innominate vein. Operative mortality was not observed in SLE patients but was observed in 1 of the 4 TVLE patients who required emergent open-chest hemostasis., Conclusions: The heart team discussion was essential to provide optimal treatment and maintain medical safety policies for each patient. SLE should be selected for patients with high risk of TVLE or other cardiac complications such as tricuspid valve incompetence., (Copyright © 2022. Published by Elsevier Ltd.)
- Published
- 2023
- Full Text
- View/download PDF
42. Assessment of the impact of organisational model of transvenous lead extraction on the effectiveness and safety of procedure: an observational study.
- Author
-
Tułecki Ł, Jacheć W, Polewczyk A, Czajkowski M, Targońska S, Tomków K, Karpeta K, Nowosielecka D, and Kutarski A
- Subjects
- Humans, Models, Organizational, Treatment Outcome, Poland, Device Removal methods, Retrospective Studies, Defibrillators, Implantable adverse effects
- Abstract
Objectives: To estimate the impact of the organisational model of transvenous lead extraction (TLE) on effectiveness and safety of procedures., Design: Post hoc analysis of patient data entered prospectively into a computer database., Setting: Data of all patients undergoing TLE in three centres in Poland between 2006 and 2021 were analysed., Participants: 3462 patients including: 985 patients undergoing TLE in a hybrid room (HR), with cardiac surgeon (CS) as co-operator, under general anaesthesia (GA), with arterial line (AL) and with transoesophageal echocardiography (TEE) monitoring (group 1), 68 patients-TLE in HR with CS, under GA, without TEE (group 2), 406 patients-TLE in operating theatre (OT) using 'arm-C' X-ray machine with CS under GA and with TEE (group 3), 154 patients-TLE in OT with CS under GA, without TEE (group 4), 113 patients-TLE in OT with anaesthesia team, using the 'arm-C' X-ray machine, without CS (group 5), 122 patients-TLE in electrophysiology lab (EPL), with CS under intravenous analgesia without TEE and AL (group 6), 1614 patients-TLE in EPL, without CS, under intravenous analgesia without TEE and AL (group 7)., Key Outcome Measure: Effectiveness and safety of TLE depending on organisational model., Results: The rate of major complications (MC) was higher in OT/HR than in EPL (2.66% vs 1.38%), but all MCs were treated successfully and there was no MC-related death. The use of TEE during TLE increased probability of complete procedural succemss achieving about 1.5 times (OR=1.482; p<0.034) and were connected with reduction of minor complications occurrence (OR=0.751; p=0.046)., Conclusions: The most important condition to avoid death due to MC is close co-operation with cardiac surgery team, which permits for urgent rescue cardiac surgery. Continuous TEE monitoring plays predominant role in immediate decision on rescue sternotomy and improves the effectiveness of procedure., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)
- Published
- 2022
- Full Text
- View/download PDF
43. Cardiac surgery simulation: Advances in transvenous lead extraction.
- Author
-
Torres Terreros CB, Miguelena Hycka J, Menendez JL, García MM, and Stuart JR
- Subjects
- Humans, Device Removal methods, Treatment Outcome, Retrospective Studies, Defibrillators, Implantable, Cardiac Surgical Procedures, Surgeons
- Abstract
The clinical importance of procedures for transvenous lead extraction has increased greatly because the volume of cardiac implantable electronic devices has increased. Consequently, the number of device-related complications requiring lead extraction has also been increasing. Great improvements in lead extraction techniques have occurred in recent years with the development of transvenous lead extraction tools and techniques. Experienced centres can achieve high success rates with infrequent complications. However, even in experienced hands, life-threatening complications can occur, and any physician performing these procedures must be prepared and trained for such eventualities. Moreover, because the occurrence of these stressful situations cannot be accurately predicted, training obtained in simulated environments can be decisive. We have developed a training module that simulates all the ordered steps of a transvenous lead extraction procedure and thus is able to help surgeons refine their surgical techniques and improve their performance., (© The Author 2022. Published by MMCTS on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.)
- Published
- 2022
- Full Text
- View/download PDF
44. Cardiac tamponade as an inherent but potentially nonfatal complication of transvenous lead extraction: Experience with 1126 procedures performed using mechanical tools.
- Author
-
Nowosielecka D, Tułecki Ł, Jacheć W, Polewczyk A, Tomków K, Stefańczyk P, Bródka J, and Kutarski A
- Subjects
- Humans, Female, Device Removal adverse effects, Device Removal methods, Equipment Failure, Stroke Volume, Treatment Outcome, Ventricular Function, Left, Retrospective Studies, Defibrillators, Implantable adverse effects, Cardiac Tamponade diagnostic imaging, Cardiac Tamponade etiology, Cardiac Tamponade therapy, Pacemaker, Artificial adverse effects
- Abstract
Introduction: Cardiac tamponade (CT) is one of the most common and dangerous complications of transvenous lead extraction (TLE). So far, however, there has been little discussion about the problem., Methods: We analyzed the occurrence of CT in a group of 1226 patients undergoing TLE at a single reference center between June, 2015 and February, 2021. Using standard mechanical devices as first-line tools, a total of 2092 leads had been extracted., Results: CT occurred in 18 patients (1.47%): due to injury to the wall of the right atrium in 14 patients (1.14%) and other cardiac walls in four patients (0.33%). Younger patient age at first implantation, female gender, high left ventricular ejection fraction (LVEF), lower New York Heart Association class, low Charlson comorbidity index, longer implant duration, and the number of previous procedures related to cardiac implantable electronic devices (CIED) are important patient-related risk factors for CT. Significant procedure-related risk factors include the number of extracted leads, extraction of atrial leads and longer dwell time of extracted leads. Intraoperative transoesophageal echocardiography (TEE) provides a lot of information about pulling on various cardiac structures and is able to detect a very early phase of bleeding to the pericardial sac. As a result of implementing best practices guidance in performing extraction procedures and close collaboration with cardiac surgeons that allowed immediate rescue intervention in our series of 18 CT cases, there were no procedure-related deaths (mortality 0%)., Conclusions: The need for rescue surgery due to CT has no influence on clinical and procedural success. Early diagnosed (TEE monitoring) and properly managed CT does not generate any additional risk in short- and long-term follow-up after TLE., (© 2022 Wiley Periodicals LLC.)
- Published
- 2022
- Full Text
- View/download PDF
45. Prognostic value of renal failure in patients undergoing transvenous lead extraction: single centre experience and systematic review of the literature.
- Author
-
Massaro G, Spadotto A, Canovi L, Martignani C, Ziacchi M, Angeletti A, Galie N, Boriani G, Biffi M, and Diemberger I
- Subjects
- Humans, Prognosis, Device Removal adverse effects, Device Removal methods, Treatment Outcome, Retrospective Studies, Defibrillators, Implantable adverse effects, Prosthesis-Related Infections etiology, Renal Insufficiency complications, Pacemaker, Artificial adverse effects
- Abstract
Introduction: Cardiac implantable electronic device infections (CIEDI) are challenging complications, associated with high mortality rate. Transvenous lead extraction (TLE) is the only curative treatment for CIEDI. Albeit continuous improvement in tools and techniques dramatically decreased TLE associated complications, survival after TLE for CIEDI is still poor. Renal failure (RF) is frequently reported in candidates to TLE, but due to variability in its definition, the real prevalence is not well defined., Objective: Considering the impact of RF on mortality among patients affected by cardiovascular diseases, we aimed our research at defining the role of RF as a predictor of post-TLE mortality., Method and Results: We will provide the results of a systematic revision of literature on the impact of RF on mortality at different time points after TLE, according to the various definitions adopted for RF. Considering the high variability of literature in this field, we will provide the results of an explorative analysis comparing the different definitions of RF on clinical outcomes in a cohort of candidates to TLE for CIEDI in a high-volume referral center., Conclusion: We discuss the possible reasons of the negative impact of RF after TLE, providing new perspectives for future research.
- Published
- 2022
- Full Text
- View/download PDF
46. Prospective Evaluation of the Correlation Between Gated Cardiac Computed Tomography Detected Vascular Fibrosis and Ease of Transvenous Lead Extraction.
- Author
-
Patel D, Vatterott P, Piccini J, Epstein LM, Hakmi S, Syed I, Koweek LM, Bolen M, Schoenhagen P, Tarakji KG, Francis N, Shao M, and Wilkoff BL
- Subjects
- Humans, Device Removal methods, Vena Cava, Superior, Retrospective Studies, Treatment Outcome, Tomography, X-Ray Computed, Fibrosis, Pacemaker, Artificial adverse effects, Defibrillators, Implantable adverse effects
- Abstract
Background: Difficulty of lead extraction does not track well with procedural complications, but several small retrospective studies have lead fibrosis on computed tomography as an important indicator of difficult lead extraction. The purpose of the present study was to apply a standardized gated cardiac computed tomography (CT) protocol to assess fibrosis and study it prospectively to examine the need for powered sheaths and risk outcomes., Methods: We performed a prospective, blinded, multicenter, international study at high-volume lead extraction centers and included patients referred for transvenous lead extraction with at least one lead with a dwell time >1 year and ability to receive a cardiac CT. The degree of fibrosis (as measured by amount of lead adherence to vessel wall) was graded on a scale of 1 to 4 by dedicated CT readers in 3 zones (vein entry to superior vena cava, superior vena cava, and right atrium to lead tip). The primary outcome of the study was number of extractions requiring powered sheaths at zone 2 for each fibrosis group., Results: A total of 200 patients were enrolled in the trial with 196 completing full gated CT and lead extraction analysis. The primary endpoint of powered sheath (laser and mechanical) sheath use was significantly higher in patients with higher fibrosis seen on CT (scores 3+4; 67.8%) at the zone 2 compared to patients with lower fibrosis (scores 1+2; 38.6%; P <0.001). There were 5 major complications with 3 vascular lacerations all occurring in zone 2 in the study., Conclusions: Gated, contrasted CT can predict the need for powered sheaths by identification of fibrosis but did not identify an absolute low-risk cohort who would not need powered sheaths., Registration: URL: https://www., Clinicaltrials: gov; Unique identifier: NCT03772704.
- Published
- 2022
- Full Text
- View/download PDF
47. The GermAn Laser Lead Extraction RegistrY: GALLERY.
- Author
-
Pecha S, Burger H, Chung DU, Möller V, Madej T, Maali A, Osswald B, De Simone R, Monsefi N, Ziaukas V, Erler S, Elfarra H, Perthel M, Wehbe MS, Ghaffari N, Sandhaus T, Busk H, Schmitto JD, Bärsch V, Easo J, Albert M, Treede H, Nägele H, Zenker D, Hegazy Y, Ahmadi D, Gessler N, Ehrlich W, Romano G, Knaut M, Reichenspurner H, Willems S, Butter C, and Hakmi S
- Subjects
- Aged, Child, Device Removal methods, Female, Humans, Lasers, Excimer, Postoperative Complications etiology, Registries, Retrospective Studies, Treatment Outcome, Defibrillators, Implantable adverse effects, Pacemaker, Artificial adverse effects, Renal Insufficiency, Chronic
- Abstract
Aims: The GermAn Laser Lead Extraction RegistrY: GALLERY is a retrospective, national multicentre registry, investigating the safety and efficacy of laser lead extraction procedures in Germany., Methods and Results: Twenty-four German centres that are performing laser lead extraction have participated in the registry. All patients, treated with a laser lead extraction procedure between January 2013 and March 2017, were consecutively enrolled. Safety and efficacy of laser lead extraction were investigated. A total number of 2524 consecutive patients with 6117 leads were included into the registry. 5499 leads with a median lead dwell time of 96 (62-141) months were treated. The mean number of treated leads per patient was 2.18 ± 1.02. The clinical procedural success rate was 97.86% and the complete lead removal was observed in 94.85%. Additional extraction tools were used in 6.65% of cases. The rate of procedural failure was 2.14% with lead age ≥10 years being its only predictor. The overall complication rate was 4.32%, including 2.06% major and 2.26% minor complications. Procedure-related mortality was 0.55%. Female sex and the presence of abandoned leads were predictors for procedure-related complications. The all-cause in-hospital mortality was 3.56% with systemic infection being the strongest predictor, followed by age ≥75 years and chronic kidney disease., Conclusion: In the GALLERY, a high success- and low procedure-related complication rates have been demonstrated. In multivariate analysis, female sex and the presence of abandoned leads were predictors for procedure-related complications, while the presence of systemic infection, age ≥75 years, and chronic kidney disease were independent predictors for all-cause mortality., Competing Interests: Conflict of interest: S.P. reports grants and personal fees from Philips/Spectranetics, Medtronic, and AtriCure. H.B. reports grants and personal fees from Philips/Spectranetics, Cook Medical, Zoll Medical, Braun Medical, Abbott, Sorin Group/LivaNova, Impulse Dynamics, Biotronik, and Medtronic. B.O. reports grants and personal fees from Philips/Spectranetics and Medtronic. H.E. reports personal fees from Philips/Spectranetics. N.G. reports grants and personal fees from Boston Scientific, Medtronic, and Bayer Vital. M.K. reports grants and personal fees from Philips/Spectranetics, Zoll Medical, Sorin Group/LivaNova, Medtronic, Boston Scientific, and CVRx. H.R. reports personal fees from Medtronic. S.W. reports grants and personal fees from Abbott, Boston Scientific, Medtronic, Boehringer Ingelheim, Bristol Myers Squibb, Bayer Vital, Acutus, and Daiichi Sankyo. S.H. reports grants and personal fees from Boston Scientific, Edwards Lifesciences, Medtronic, Meril, Philips/Spectranetics, and Zoll Medical. All other authors have no conflicts of interest., (© The Author(s) 2022. Published by Oxford University Press on behalf of the European Society of Cardiology. All rights reserved. For permissions, please email: journals.permissions@oup.com.)
- Published
- 2022
- Full Text
- View/download PDF
48. Complications in Device Therapy: Spectrum, Prevalence, and Management.
- Author
-
Llewellyn J, Garner D, and Rao A
- Subjects
- Device Removal adverse effects, Device Removal methods, Humans, Prevalence, Defibrillators, Implantable adverse effects, Heart Failure complications, Prosthesis-Related Infections etiology, Prosthesis-Related Infections surgery
- Abstract
Purpose of Review: Cardiac implantable electronic device implant numbers are continually increasing due to the expanding indications and ageing population. This review explores the complications associated with device therapy and discusses ways to minimise and manage such complications., Recent Findings: Complications related to device therapy contribute to mortality and morbidity. Recent publications have detailed clear guidelines for appropriate cardiac device selection, as well as consensus documents discussing care quality and optimal implantation techniques. There have also been advances in device technologies that may offer alternative options to patients at high risk of/or already having encountered a complication. Adherence to guidelines, appropriate training, and selection of device, in addition to good surgical technique are key in reducing the burden of complications and improving acceptability of device therapy., (© 2022. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.)
- Published
- 2022
- Full Text
- View/download PDF
49. Usefulness of the controlled-rotation dilator sheath "Evolution RL" for extraction of old leads in two Japanese centers - An experience in use.
- Author
-
Tabata H, Okada A, Kobayashi H, Shoin W, Okano T, Higuchi S, Yagishita D, Ebisawa S, Motoki H, Shoda M, and Kuwahara K
- Subjects
- Device Removal methods, Female, Humans, Japan, Male, Middle Aged, Retrospective Studies, Treatment Outcome, Defibrillators, Implantable, Pacemaker, Artificial
- Abstract
Background: Transvenous lead extraction (TLE) is an established procedure for the management of cardiovascular implantable electronic devices. However, some difficulties and risks of complications still exist, especially in old and adhered leads. Evolution RL (Cook Medical, Bloomington, IN, USA) is a newly introduced device for TLE; however, no clinical results have been reported in Japan, and the results with older leads are unknown. We investigated the efficacy and safety of Evolution RL and its usefulness for old leads at two TLE centers in Japan., Methods: A total of 27 consecutive patients who underwent lead extraction using Evolution RL at Shinshu University Hospital and Tokyo Women's Medical University Hospital from September 2017 to December 2019 were retrospectively enrolled. We examined the backgrounds of the patients and leads and investigated the efficacy and safety of the procedures. We divided the leads into two groups according to the number of years of implantation (10 years) and compared the results., Results: Among the 27 patients, 20 (74.1%) were men, and the median age was 62 (14-91) years. The total number of leads was 58, and the median implantation duration was 136 months (8-448). We achieved clinical success in all patients and complete procedural success in 24 patients (88.9%). In three patients, the broken tip of the lead remained in the heart. No major complications were noted. Of the 58 leads, there were 34 leads with more than 10 years of implantation, with significantly more Evolution RLs used (94.1% vs. 54.2%, p = 0.001) and significantly higher percentages of Evolution 11Fr, 13Fr, and steady sheaths used (79.4% vs. 33.3%, p = 0.001, 52.9% vs. 16.7%, p = 0.006, and 64.7% vs. 20.8%, p = 0.001, respectively)., Conclusions: In two TLE centers in Japan, Evolution RL was shown to be safe and effective, even in leads older than 10 years., Competing Interests: Declaration of competing interest The authors declare no conflict of interest for this article., (Copyright © 2022 The Authors. Published by Elsevier Ltd.. All rights reserved.)
- Published
- 2022
- Full Text
- View/download PDF
50. Lead-related infective endocarditis with vegetations: Prevalence and impact of pulmonary embolism in patients undergoing transvenous lead extraction.
- Author
-
Bontempi L, Arabia G, Salghetti F, Cerini M, Dell'Aquila A, Milidoni A, Ahmed A, Cersosimo A, Giacopelli D, Mitacchione G, Raweh A, Muneretto C, and Curnis A
- Subjects
- Device Removal methods, Humans, Prevalence, Retrospective Studies, Defibrillators, Implantable adverse effects, Endocarditis diagnostic imaging, Endocarditis epidemiology, Endocarditis, Bacterial diagnostic imaging, Endocarditis, Bacterial epidemiology, Pacemaker, Artificial adverse effects, Prosthesis-Related Infections diagnostic imaging, Prosthesis-Related Infections epidemiology, Prosthesis-Related Infections etiology, Pulmonary Embolism diagnostic imaging, Pulmonary Embolism epidemiology, Pulmonary Embolism therapy
- Abstract
Introduction: The prevalence and impact of pulmonary embolism (PE) in patients with lead-related infective endocarditis undergoing transvenous lead extraction (TLE) are unknown., Methods: Twenty-five consecutive patients with vegetations ≥10 mm at transoesophageal echocardiography were prospectively studied. Contrast-enhanced chest computed tomography (CT) was performed before (pre-TLE) and after (post-TLE) the lead extraction procedure., Results: Pre-TLE CT identified 18 patients (72%) with subclinical PE. The size of vegetations in patients with PE did not differ significantly from those without (median 20.0 mm [interquartile range: 13.0-30.0] vs. 14.0 mm [6.0-18.0], p = 0.116). Complete TLE success was achieved in all patients with 3 (2-3) leads extracted per procedure. There were no postprocedure complications related to the presence of PE and no differences in terms of fluoroscopy time and need for advanced tools. In the group of positive pre-TLE CT, post-TLE scan confirmed the presence of silent PE in 14 patients (78%). There were no patients with new PE formation. Large vegetations (≥20 mm) tended to increase the risk of post-TLE subclinical PE (odds ratio 5.99 [95% confidence interval (CI): 0.93-38.6], p = 0.059). During a median 19.4 months follow-up, no re-infection of the implanted system was reported. Survival rates in patients with and without post-TLE PE were similar (hazard ratio: 1.11 [95% CI: 0.18-6.67], p = 0.909)., Conclusion: Subclinical PE detected by CT was common in patients undergoing TLE with lead-related infective endocarditis and vegetations but was not associated with the complexity of the procedure or adverse outcomes. TLE procedure seems safe and feasible even in patients with large vegetations., (© 2022 The Authors. Journal of Cardiovascular Electrophysiology published by Wiley Periodicals LLC.)
- Published
- 2022
- Full Text
- View/download PDF
Catalog
Discovery Service for Jio Institute Digital Library
For full access to our library's resources, please sign in.