|Year : 2021 | Volume
| Issue : 1 | Page : 54-59
Safety and efficacy of transvenous lead removal after cardiovascular implantable electronic device infection in the older patients: A retrospective cohort study (english version)
Jia Zheng, Yuan Gao, Rongfang Lan, Wei Xu
Department of Cardiology, Drum Tower Hospital, Nanjing University Medical School, Nanjing, Jiangsu Province, China
|Date of Submission||27-Apr-2021|
|Date of Decision||28-May-2021|
|Date of Acceptance||03-Jun-2021|
|Date of Web Publication||30-Jun-2021|
Dr. Rongfang Lan
Department of Cardiology, Drum Tower Hospital, Road Zhongshan 321, Gulou District, Nanjing, Jiangsu Province
Dr. Wei Xu
Department of Cardiology, Drum Tower Hospital, Road Zhongshan 321, Gulou District, Nanjing, Jiangsu Province
Source of Support: None, Conflict of Interest: None
Background: Cardiovascular implantable electronic device (CIED) infection is a life-threatening complication following pacemaker therapy. Complete CIED removal is the first-line therapy for patients with CIED system infection. However, the safety and efficacy of transvenous lead removal of infected CIED in older patients (≥75 years of age) are unknown. Thus, our study aimed to investigate the safety and efficacy of transvenous lead removal of infected CIED in older patients. Subjects and Methods: This is a single-center retrospective cohort study in which 316 patients with transvenous lead removal after CIED infections were recruited from Nanjing Drum Tower Hospital between January 2013 and October 2019. We evaluated the safety of the CIED removal based on the rate of major complications (e.g., lead perforation, coronary sinus tear, and pericardial tamponade) and minor complications (e.g., minor pericardial effusion, venous thrombus, and minor hematoma). Procedural success rate and infection recurrence were used to evaluate the efficacy. The differences in gender, comorbidities, type of implanted devices, number and type of leads, anesthesia method, extraction strategies, complications, and complete removal rate were also analyzed. The study was approved by the Ethics Committee of Drum Tower Hospital, Nanjing University Medical School (approval No. 2019-230-01) on February 1, 2019. Results: In total, 316 patients were included, of whom 115 patients were ≥75 years old, and 79 were male. There were more defibrillation devices in the <75-year-old group (10.9% vs. 4.3%, P = 0.044). Seven cases (6.1%, 7/115) in the ≥75-year-old group had minor complications without major complications, whereas ten cases (5.0%, 10/201, P = 0.796) of <75-year-old group had minor complications with one case had major complications. 111 patients (96.5%, 111/115) in the ≥75-year-old group had complete removal of the pacing system. Four patients (3.5%, 4/115) achieved clinical success without removal failure. 191 patients (95.0%, 191/201, P = 0.933) in the <75-year-old group had complete removal of the pacing system, and nine patients (4.5%, 9/201, P = 0.776) had clinical success with 1 case (0.5%, 1/201) being failed to remove pacing system. Overall, there was no significant difference in the safety and efficacy among the two groups. Conclusions: Transvenous lead removal is safe and curative in patients ≥75 years old with CIED infections.
Keywords: Cardiovascular implantable electronic device infection, efficacy, older patient, safety, transvenous lead removal
|How to cite this article:|
Zheng J, Gao Y, Lan R, Xu W. Safety and efficacy of transvenous lead removal after cardiovascular implantable electronic device infection in the older patients: A retrospective cohort study (english version). Int J Heart Rhythm 2021;6:54-9
|How to cite this URL:|
Zheng J, Gao Y, Lan R, Xu W. Safety and efficacy of transvenous lead removal after cardiovascular implantable electronic device infection in the older patients: A retrospective cohort study (english version). Int J Heart Rhythm [serial online] 2021 [cited 2021 Dec 8];6:54-9. Available from: https://www.ijhronline.org/text.asp?2021/6/1/54/319974
Jia Zheng, Yuan Gao: Both authors contributed equally to this work.
This manuscript is an English version based on Zheng J, Gao Y, Lan R, Xu W. The safety and efficacy of transvenous lead extraction of infected cardiovascular implantable electronic devices in geriatric patients. Chin J Cardiac Arrhyth 2021;25(1):77-81. The second publication of this manuscript has obtained the permission from Chinese Journal of Cardiac Arrhythmias.
| Introduction|| |
Cardiovascular implantable electronic device (CIED) infections are a serious postimplantation complication. Over the past 20–30 years, the incidence of CIED infections has been on the rise, with a greater increase in the elderly population than in the younger population., The guideline recommends the complete removal of the device and lead as a Class I recommendation for the treatment of CIED-related infections and suggests that age is an independent risk factor for postoperative CIED infection., From 2003 to 2011, 56.4% of patients aged 65–84 years in the United States had their pacing systems completely removed, with an in-hospital mortality rate of 4.4%, and 5.3% for those aged 85 years or older. Complete removal of CIED in the older patients may be associated with a high risk. In China, due to the relatively low distribution of transvenous lead removal technology and the lack of relevant equipment and experience in general hospitals, conservative treatment remains the main solution for CIED infection in the older adults. In this study, we recruited 316 patients who had transvenous CIED removal due to the infection. We aimed to investigate the safety and efficacy of transvenous lead removal of infected CIED in patients ≥75 years of age.
| Subjects and Methods|| |
In this single-center retrospective cohort study, we enrolled a total of 316 consecutive patients undergoing transvenous lead removal after CIED infections from the Department of Cardiology, Drum Tower Hospital, Nanjing University Medical School, from January 2013 to October 2019. The study was approved by the Ethics Committee of Drum Tower Hospital, Nanjing University Medical School (approval No. 2019-230-01, approval date: February 1, 2019) and conducted in accordance with the Declaration of Helsinki. All patients signed written informed consent form for transvenous lead removal.
Patients diagnosed with CIED infection in accordance with 2017 expert consensus statement on CIED lead management and removal.
The patients were excluded if they were indicated for surgical removal (e.g., comorbid massive vegetation), <18 years of age, pregnant, and involved in another trial within 30 days.
Sample size calculation
According to theepidemiological statistics, the rate of complications associated with infected CIED removal was 5.5–16.4%., To our knowledge, the safety and efficacy of transvenous lead removal of infected CIED in the older adults are limited, so we decided to estimate the complication rate in the older patients as 14.6% and younger adults as 5.5%. We defined type I error of 0.05 while a reliability of 80%. The assumed data were determined as the low limit of 95% confidence interval. Assuming a dropout rate of 10%, we calculated an estimated sample size of 107 patients in the older group and 197 patients in the younger group.
The operation was performed under X-ray in the catheterization laboratory, with local infiltration anesthesia or general anesthesia (Dräger Fabius® Plus, Lübeck, Germany), temporary pacemaker implantation for pacing-dependent patients. Cardiothoracic surgery is routinely prepared in case of possible major surgical complications. We removed the CIED as the following the protocols: (1) For intact or long residual leads, the superior vena cava route is preferred. (2) If simple manual traction fails, the lead is disconnected and a locking guidewire (Cook, Bloomington, IN, USA) is used to insert and lock the distal end to the inner core of the lead to provide support and coaxiality. If manual removal is still unsuccessful, severe adhesions should be considered and the appropriate type of double overlapping expansion sheath (LR-EVN-SH, Cook) or Evolution mechanical cutting sheath (Cook) should be selected to separate the adhesions and remove the lead using a counter-thrust traction technique. (3) In cases where locking guidewire cannot be locked (e.g., inadequate leads remnant, occluded central lumen, and leads fracture causing traveling back into the vessel), the inferior vena cava route is preferred. (4) Removal of the lead remnant is performed via snare through the femoral vein, relying on heartbeat reaction force. (5) The removed lead is routinely sent for blood culture to guide the use of postoperative antibiotics. After complete removal, the CIED pocket is thoroughly debrided to remove sinus tracts, fistulas, and dead spaces and then carefully sutured.
Definitions for removal complications
Complications are classified as minor and major complications according to the 2017 expert consensus on CIED management and removal for Heart Rhythm Society. Major complications can pose an immediate threat to life and even result in death (e.g., lead perforation, coronary sinus tear, and pericardial tamponade), whereas minor complications are undesired adverse events that require medical interventions but do not significantly affect the patient's function (e.g., minor pericardial effusion, venous thrombus, and minor hematoma).
Definitions for extraction success
Complete procedural success is defined as the removal of all targeted leads, all lead material from the vascular space without any permanently disabling complications or procedure-related death. Clinical success is defined as the removal of all targeted leads and lead material or retention of a small portion of the lead (<4 cm) that does not influence the clinical goals of the operation. Failure is defined as lead removal that cannot be accomplished by transvenous routine.
The data were processed using SPSS 19.0 statistical software (IBM, Armonk, NY, USA). Continuous variables were reported as mean ± standard deviation. Categorical variables were collected as percentages. The difference between the two groups was compared by the chi-square test or the Fisher's exact test. A two-sided P = 0.05 was defined as statistically significant.
| Results|| |
There were 324 patients who met the inclusion criteria and eight patients were excluded according to the exclusion criteria [Figure 1]. Baseline characteristics of the younger (n = 201) and older group (n = 115) are summarized in [Table 1]. 113 patients (35.8%) had a medical history of CIED pocket debridement before admission. In the older group (≥75 years old), the device type was a single-chamber pacemaker in 24 patients (20.9%), dual-chamber pacemaker in 81 (70.4%), cardiac resynchronization therapy device (CRT-P) in 5 (4.3%), and implantable cardioverter-defibrillator with or without cardiac resynchronization therapy function (CRTD/implantable cardioverter defibrillator [ICD]) in 5 (4.3%). In the younger group (<75 years old), the device type was a single-chamber pacemaker in 34 patients (16.9%), dual-chamber pacemaker in 140 (69.7%), CRT-P in 6 (3.0%), and CRTD/ICD in 22 (10.9%). One patient had two episodes of CIED infections. As compared with the younger group, the older group had more ICD devices (10.9% vs. 4.3%, P = 0.044). A total of 224 leads were removed from the 115 patients in the older group, whereas 399 leads were removed from the 201 patients in the younger group.
Over 99% of patients in the younger (114/115) and older groups (119/201) underwent successful CIED removal through local anesthesia. The average operation time was similar between younger group (122.00 ± 51.33 min) and older group (122.70 ± 56.60 min, P = 0.538). There were 62 patients in the older group and 113 patients in the younger group who used a double overlapping expansion sheath or Evolution mechanical cutting sheath to separate the adhesions. There was no significant difference between two groups in the type of anesthesia, implantation period of leads wire, number of leads, method of extraction, and average operative time [Table 2].
Clinical outcome and complications
There was no procedure-related death in either group. The complications in the older group included minor pericardial effusion (1 case), minor hematoma (5 cases), and blood transfusion (2/3 cases combined hematoma) with no major complications. The complications in the younger group were minor pericardial effusion (1 case), venous thrombus (4 cases), minor hematoma (5 cases), blood transfusion (one case combined hematoma and one case combined venous thrombus), and pericardial tamponade (one patient presented with an increase in pericardial drainage after removing the right ventricular lead, and was then discharged after successful cardiac surgery). 96.5% of the patients in the older group (111/115) achieved complete procedural success, 3.5% (4/115) of the patients had gained clinical success without any failure. 95.0% of patients in the younger group (191/201) achieved complete procedural success, 4.5% (9/201) patients had gained clinical success, and 0.5% (1/201) patient was referred to the cardiac surgeon for leads extraction [Table 2].
| Discussion|| |
In this study, 113 patients (35.8%) had a medical history of CIED pocket debridement before admission, which suggests the limited efficacy of CIED infections. To date, complete removal of CIED remains the first-line treatment for those patients.
Former studies have reported that the complete success rate of transvenous lead removal is 95.1%–98.0%, with the major complications rate of 0.7%–2.0%., Li et al. concluded that transvenous lead removal has a high removal success rate and a low complication rate by using tools such as the Evolution cutting sheath. Kutarski et al. reported that 192 patients over 80 years of age (102 with CIED infection) had transvenous lead removal with a major complication rate of 1.56% and the complete removal rate of 97.4%. Thus, they concluded that transvenous lead removal is equally safe and effective in older adults. Proietti et al. reported a case of successful transvenous removal in a 90-year-old patient with ICD infection. In their risk stratification, Fu et al. reported that age was not a risk factor for major complications of the procedure. These studies suggest that transvenous lead removal may be a safe treatment option for the older patients with CIED infection. Our data suggest no statistical significance of major or minor complication rates between the older group and the younger group. Thus, we proved the safety and efficacy of transvenous lead removal after CIED infection in the older patients.
Our center accumulates experience in improving the success rate of infected CIED removal and avoiding complications, which is summarized below.
After admission, individual risk stratification should be measured by transthoracic echocardiography and computed tomography. That helps identify the spatial relationships among the lead, tricuspid valve, and endocardium, together with the size of latent vegetations in the CIED patients diagnosed with infective endocarditis. The ESC guideline indicates that the number of lead (≥3) and implantation period (≥10 years) are independent risk factors for major complications. Open heart surgery should be considered for the patients meeting the following criteria: (i) having multiple infected leads, (ii) having leads with long implantation period, and (iii) having difficulty in transvenous route.
Appropriate antibiotic therapy can avoid endocarditis. Preoperative culture of local infected tissues and secretion. We prefer broad-spectrum antibiotics (e.g., vancomycin, teicoplanin) for culture-negative patients. The appropriate antibiotics are chosen according to the antimicrobial susceptibility test for the culture-positive patients. Transvenous removal is a retrograde procedure. To avoid the occurrence of medical-derived bacteremia and infective endocarditis, the incision should be selected reasonably, which can be handled in stages. Deal with the noninfected lead first, then the infected pacemaker pocket and lead.
For the pacemaker-dependent patients with CIED infection, we prefer a modified temporary pacing method through the external jugular vein. Compared to the conventional approach via the femoral vein, the patient does not need to be immobilized after the procedure. Li et al. showed that modified temporary pacemakers can reduce the risk of postoperative venous thrombosis and pulmonary embolism. Because of the underlying adhesion between multiple infected leads, extracting any of them may lead to losing the capture of the temporary pacing lead and thus cause a life-threatening risk to the pacemaker-dependent patient. In this case, we suggest two temporary pacing leads should be implanted.
Based on our experience, the subclavian vein entrance, the joint between the superior vena cava and subclavian vein, and the tip of the infected leads tend to have more serious adhesions. We often attempt to remove the lead manually if the implantation period <1 year. Increasing the extracting force should be avoided if the diagram shifting is observed under the X-ray. It is crucial to the procedure because vascular intima tear will increase difficulties for insertion of the locking guidewire. Li et al. demonstrated that the Evolution cut sheath (Cook, Bloomington, Indiana, USA) was more effective than the double-jacketed dilated sheath. Li et al. showed that the Evolution cutting sheath was more suitable for extracting the infected leads with a long insertion period. When using the extraction tool, the locking guidewire should be first sent to the distal end of the infected lead, avoiding the lead fracture during the procedure. It is essential to maintain appropriate tension on the locking guidewire to establish the track of the mechanical cutting sheath. Too much tension avulses the vessel, while too little tension may cause damage to the vessel during the separation of the adhesive tissue. Depending on the location of the adhesions, the appropriate evolution sheath should be selected. A long sheath should be used for severe adhesions in the superior vena cava, while a short mechanical sheath should be selected for severe adhesions in the subclavian vein. The short mechanical sheath allows the tip of the sheath to be kept parallel to the lead when dealing with adhesions proximal to the puncture, thus avoiding breakage of the lead tip in the subclavian vein during cutting Wu and Xu reported a case in which the tip of the lead was disconnected in the subclavian vein during the extraction of the Evolution sheath and was then successfully taken out using a snare.
The majority of foreign centers extracted the infected leads under general anesthesia. The 2017 European Lead Management Registry reported a relatively even rate of anesthesia methods: 39% for general anesthesia, 31% for local anesthesia, and 30% for sedation., In more than 99% of our patients, the leads were removed intravenously under local anesthesia with a high success rate. We believe that local anesthesia is safe and available. However, due to inadequate cases of lead removal under general anesthesia in our center, expansion of the sample size is necessary to compare the clinical features of different anesthetic modalities.
A limitation of our study is the study participants were from a single center, for the success of transvenous CIED removal is highly dependent on the physicians' experience. We need to recruit more CIED infection patients from other centers to validate the procedural safety and efficacy.
| Conclusions|| |
Transvenous lead removal is safe and effective in patients with CIED infections at the age of ≥75 years.
Financial support and sponsorship
Conflicts of interest
There are no conflicts of interest.
Editor note: WX is an Editorial Board member of International Journal of Heart Rhythm. The article was subject to the journal's standard procedures, with peer review handled independently of this Editorial Board member and their research groups.
Institutional review board statement
The study was approved by the Ethics Committee of Drum Tower Hospital, Nanjing University Medical School (Approval No. 2019-230-01, approval date: February 1, 2019) and conducted in accordance with the Declaration of Helsinki.
Declaration of patient consent
The authors certify that they have obtained all appropriate consent from patients. In the forms, the patients have given their consent for their images and other clinical information to be reported in the journal. The patients understand that their names and initials will not be published and due efforts will be made to conceal their identity forms.
| References|| |
Greenspon AJ, Patel JD, Lau E, Ochoa JA, Frisch DR, Ho RT, et al.
16-year trends in the infection burden for pacemakers and implantable cardioverter-defibrillators in the United States 1993 to 2008. J Am Coll Cardiol 2011;58:1001-6.
Dai M, Cai C, Vaibhav V, Sohail MR, Hayes DL, Hodge DO, et al.
Trends of cardiovascular implantable electronic device infection in 3 decades: A population-based study. JACC Clin Electrophysiol 2019;5:1071-80.
Kusumoto FM, Schoenfeld MH, Wilkoff BL, Berul CI, Birgersdotter-Green UM, Carrillo R, et al.
2017 HRS expert consensus statement on cardiovascular implantable electronic device lead management and extraction. Heart Rhythm 2017;14:e503-51.
Slotwiner D, Varma N, Akar JG, Annas G, Beardsall M, Fogel RI, et al.
HRS Expert Consensus Statement on remote interrogation and monitoring for cardiovascular implantable electronic devices. Heart Rhythm 2015;12:e69-100.
Sridhar AR, Lavu M, Yarlagadda V, Reddy M, Gunda S, Afzal R, et al.
Cardiac implantable electronic device-related infection and extraction trends in the U.S. Pacing Clin Electrophysiol 2017;40:286-93.
Le KY, Sohail MR, Friedman PA, Uslan DZ, Cha SS, Hayes DL, et al.
Impact of timing of device removal on mortality in patients with cardiovascular implantable electronic device infections. Heart Rhythm 2011;8:1678-85.
Viganego F, O'Donoghue S, Eldadah Z, Shah MH, Rastogi M, Mazel JA, et al.
Effect of early diagnosis and treatment with percutaneous lead extraction on survival in patients with cardiac device infections. Am J Cardiol 2012;109:1466-71.
Segreti L, Rinaldi CA, Claridge S, Svendsen JH, Blomstrom-Lundqvist C, Auricchio A, et al.
Procedural outcomes associated with transvenous lead extraction in patients with abandoned leads: An ESC-EHRA ELECTRa (European Lead Extraction ConTRolled) Registry Sub-Analysis. Europace 2019;21:645-54.
Brunner MP, Cronin EM, Duarte VE, Yu C, Tarakji KG, Martin DO, et al.
Clinical predictors of adverse patient outcomes in an experience of more than 5000 chronic endovascular pacemaker and defibrillator lead extractions. Heart Rhythm 2014;11:799-805.
Higuchi S, Shoda M, Saito S, Kanai M, Kataoka S, Yazaki K, et al.
Safety and efficacy of transvenous lead extractions for noninfectious superfluous leads in a Japanese population: A single-center experience. Pacing Clin Electrophysiol 2019;42:1517-23.
Li XB, Wang L, Li D, Liu G, Duan JB, Zeng F, et al
. A large single-center clinical trial of transvenous lead extraction. Chin J Cardiac Arrhyth 2015;19:244-9.
Kutarski A, Polewczyk A, Boczar K, Ząbek A, Polewczyk M. Safety and effectiveness of transvenous lead extraction in elderly patients. Cardiol J 2014;21:47-52.
Proietti R, Lombardi L, Quaglia C, Sagone A. Extraction of transvenous ICD leads in an over-ninety years old patient. Indian Pacing Electrophysiol J 2011;11:145-8.
Fu HX, Huang XM, Zhong LI, Osborn MJ, Asirvatham SJ, Espinosa RE, et al.
Outcomes and complications of lead removal: Can we establish a risk stratification schema for a collaborative and effective approach? Pacing Clin Electrophysiol 2015;38:1439-47.
Zucchelli G, Di Cori A, Segreti L, Laroche C, Blomstrom-Lundqvist C, Kutarski A, et al.
Major cardiac and vascular complications after transvenous lead extraction: Acute outcome and predictive factors from the ESC-EHRA ELECTRa (European Lead Extraction ConTRolled) registry. Europace 2019;21:771-80.
Li QB, Lan RF, Xu W. Application of modified temporary cardiac pacing in lead extraction patients. Chin J Cardiac Arrhyth 2018;22:408-11.
Li XH, Ji WQ, Xu W. Preliminary experience in extraction of pacemaker leads with Evolution mechanical dilator sheath. Chin J Cardiac Arrhyth 2014;18:448-50.
Wu X, Xu W. A case of successful removal of the broken tip of electrode during transvenous pacemaker lead extraction. Chin J Cardiac Arrhyth 2017;21:524-5.
Tarakji KG, Mittal S, Kennergren C, Corey R, Poole JE, Schloss E, et al.
Antibacterial envelope to prevent cardiac implantable device infection. N Engl J Med 2019;380:1895-905.
Bongiorni MG, Kennergren C, Butter C, Deharo JC, Kutarski A, Rinaldi CA, et al.
The European Lead Extraction ConTRolled (ELECTRa) study: A European Heart Rhythm Association (EHRA) registry of transvenous lead extraction outcomes. Eur Heart J 2017;38:2995-3005.
[Table 1], [Table 2]