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Transvenous lead extractions in a single high-volume center over 24 years: High success rate and low complication rate

Open AccessPublished:January 19, 2023DOI:https://doi.org/10.1016/j.hroo.2023.01.003

      Abstract and keywords

      Background

      Transvenous lead extraction (TLE) procedures can be complicated and are associated with a small but significant risk, but methods and tools vary between centers.

      Objective

      To present methods and results of pacemaker- and implantable cardioverter defibrillator (ICD) TLE procedures in our center over 24 years

      Methods

      From (April) 1997 through 2020 we attempted to extract 2964 leads in 1780 procedures and 1642 patients. We mainly used single sheath technique supplied with snaring, mechanical rotational sheaths and steel sheaths when necessary.. Difficult procedures were performed by an experienced cardiologist, and close supervision was emphasized. Most of the extractions were performed in local anaesthesia with sedation.

      Results

      Median age of patients was 65.0 (IQR = 20.00) years and median dwelling time of leads 5.0 (IQR = 7.0) years. Clinical success was achieved in 1739 procedures (97.7%), and complete technical success in 2841 leads (95.8%). Clinical success (leaving less than 4 cm of the lead in the body and achieving the clinical goal for the patient) was achieved for 79 leads (2.7%). Transvenous lead extraction failed in 44 leads (1.1 %) and 41 procedures (2.3%) among 36 (2.2%) patients. There were 23 cases (1.3%) of major complications, with only 1 death directly related to the procedure (<0.1%) Additionally, two patients with sepsis died within the first 24 hours after the procedure. No caval tears occurred.

      Conclusions

      Single sheath lead extraction supplied with snaring or mechanical rotational sheaths were effective and safe in our high volume center with experienced operators.

      Keywords

      ABBREVIATIONS:

      CIED (Cardiac implantable electronic devices), CRT (Cardiac resynchronization therapy), ICD (Implantable cardioverter defibrillator), ITA (Internal jugular access), MRS (Mechanical rotational sheaths), TFA (Transfemoral access), TLE (Transvenous lead extraction), VEA (Venous site entry approach), VES (Venous entry site)

      Introduction

      The increasing number of implanted cardiac electronic devices in recent years has led to a growing number of patients needing transvenous lead extraction (TLE).
      • Mond H.G.
      • Proclemer A.
      The 11th world survey of cardiac pacing and implantable cardioverter-defibrillators: calendar year 2009--a World Society of Arrhythmia's project.
      ,
      • Raatikainen M.J.
      • Arnar D.O.
      • Zeppenfeld K.
      • Merino J.L.
      • Kuck K.H.
      • Hindricks G.
      Current trends in the use of cardiac implantable electronic devices and interventional electrophysiological procedures in the European Society of Cardiology member countries: 2015 report from the European Heart Rhythm Association.
      New indications for pacing, implantable cardioverter defibrillators (ICD) and cardiac resynchronization therapy (CRT) systems increase the number of patients with a cardiac implantable electronic device (CIED), and consequently the number of CIED related complications. In addition, increased life expectancy in patients with CIED is associated with an increased number of CIED generator replacements or system change procedures to ICD or CRT.

      Deshmukh A, Patel N, Noseworthy PA, et al. Trends in Use and Adverse Outcomes Associated with Transvenous Lead Removal in the United States. Circulation. 2015132:2363-2371.

      ,
      • Sridhar A.R.
      • Lavu M.
      • Yarlagadda V.
      • et al.
      Cardiac Implantable Electronic Device-Related Infection and Extraction Trends in the U.S.
      Although TLE techniques have evolved from simple traction to extraction with mechanical dilatation and powered sheaths, percutaneous lead removal is still associated with a small, but significant procedural failure, morbidity and mortality.
      • Wazni O.
      • Wilkoff B.L.
      Considerations for cardiac device lead extraction.
      ,
      • Bongiorni M.G.
      • Kennergren C.
      • Butter C.
      • et al.
      The European Lead Extraction ConTRolled (ELECTRa) study: a European Heart Rhythm Association (EHRA) Registry of Transvenous Lead Extraction Outcomes.
      This is mainly due to presence of adhesions between leads and veins or cardiac chambers. We mainly used single sheath (polypropylene) dilatation technique combined with femoral and jugular snaring techniques, and the Cook EvolutionTM or Spectranetics TightRailTM mechanical rotational sheaths (MRS).
      • Mazzone P.
      • Tsiachris D.
      • Marzi A.
      • et al.
      Advanced techniques for chronic lead extraction: heading from the laser towards the evolution system.
      ,
      • Bongiorni M.G.
      • Soldati E.
      • Zucchelli G.
      • et al.
      Transvenous removal of pacing and implantable cardiac defibrillating leads using single sheath mechanical dilatation and multiple venous approaches: high success rate and safety in more than 2000 leads.
      Our approach has been similar to the techniques described by Bongiorni et al.,
      • Bongiorni M.G.
      • Soldati E.
      • Zucchelli G.
      • et al.
      Transvenous removal of pacing and implantable cardiac defibrillating leads using single sheath mechanical dilatation and multiple venous approaches: high success rate and safety in more than 2000 leads.
      ,
      • Bongiorni M.G.
      • Segreti L.
      • Di Cori A.
      • et al.
      Safety and efficacy of internal transjugular approach for transvenous extraction of implantable cardioverter defibrillator leads.
      with some modifications according to available operator´s experience and preferences and patient or lead characteristics.
      The aim of this study was to describe our methods and techniques of TLE, as well as the success rate and rate of complications, in our high-volume center from 1997 through 2020.

      Methods

      Patient Population and Preparation

      All consecutive patients admitted to Oslo University Hospital of Ullevaal for TLE from April 1997 until the end of 2020 were prospectively enrolled into a local TLE registry. There was no bias as no patients were referred for surgical extraction as first option. The patients accepted for TLE were examined and prepared according to the current consensus including clinical examination, thorough device examination, blood tests, and thoracic x-ray.
      • Love C.J.
      • Wilkoff B.L.
      • Byrd C.L.
      • et al.
      Recommendations for extraction of chronically implanted transvenous pacing and defibrillator leads: indications, facilities, training. North American Society of Pacing and Electrophysiology Lead Extraction Conference Faculty.
      • Wilkoff B.L.
      • Love C.J.
      • Byrd C.L.
      • et al.
      Transvenous lead extraction: Heart Rhythm Society expert consensus on facilities, training, indications, and patient management: this document was endorsed by the American Heart Association (AHA).

      Kusumoto FM, Schoenfeld MH, Wilkoff BL, et al. 2017 HRS expert consensus statement on cardiovascular implantable electronic device lead management and extraction. Heart Rhythm. 2017 Sep 15.

      • Deharo J.C.
      • Bongiorni M.G.
      • Rozkovec A.
      • et al.
      Pathways for training and accreditation for transvenous lead extraction: a European Heart Rhythm Association position paper.
      A pre-operative transthoracic echocardiography was performed in all cases by experienced cardiologists with special focus on the lead course through the tricuspid valve. If echocardiography indicated that one or more leads could be adherent to the tricuspid valve , the indication for TLE was re-evaluated, e.g. was the indication of TLE absolute. If TLE was performed, close attention was payed in order to avoid valve damage, e.g. avoid too much pulling of the lead. Transesophageal echocardiography prior to TLE was performed in selected cases only, mostly if lead endocarditis was suspected, but not obvious, or if suspected left sided valve endocarditis.
      Anticoagulation and antiplatelet drugs were managed according to a risk/benefit judgement. The standard approach was to stop anticoagulation two days prior to the procedure. In cases of mechanical heart valves, the procedure was performed with the patient in therapeutic international normalized ratio.

      Extraction procedure

      The TLE procedures were performed in a hybrid lab with a cardiothoracic surgery team available within few minutes, and in few cases on site in the operating room due to risk stratification. The patients were in a fasting state. All patients were monitored with blood pressure and heart rate monitoring, application of cutaneous pads for defibrillation, and invasive arterial blood pressure measuring in selected cases. Transvenous temporary pacing was used in pacemaker dependent patients and in expected difficult cases. In cases with CIED infection, we tested if discontinuation of beta-blocker and supplying theophylline or isoprenaline could increase heart rate to a hemodynamically sufficient level. This was done in order to avoid unnecessary temporary leads and minimize the risk of re-infection of the new CIED on the contralateral side. Antibiotics were administered intravenously prior to the procedure in all cases.
      The extraction procedures were performed by seven cardiologists, four of them having performed more than 250 TLE procedures each at the end of the 24-year period. The procedures were performed by the experienced cardiologist, or with one of them present in the lab together with a less experienced operator. By the end of 2020, the least experienced cardiologist had performed 40 procedures while the most experienced cardiologist had performed more than 700 lead TLE procedures. The patients were mostly sedated, with the procedures being done in local anaesthesia. General anaesthesia was applied in selected cases only, with decisive factors being patient age, comorbidity, level of anxiety, mental state and number, type, tip position and age of the leads. Some patients were converted from local anaesthesia and sedation to general anaesthesia during the procedure because of complications or pain.
      The primary approach in most of our cases was the single sheath dilatation technique as described by Bongiorni et al.,
      • Bongiorni M.G.
      • Soldati E.
      • Zucchelli G.
      • et al.
      Transvenous removal of pacing and implantable cardiac defibrillating leads using single sheath mechanical dilatation and multiple venous approaches: high success rate and safety in more than 2000 leads.
      customized to our experience and preferences. We cut the leads 6-8 cm from the venous entry site and used a locking stylet (Cook Vascular Inc. Bloomington, USA or Spectranetics Corp. (now Philips), Colorado Springs, USA) in most cases as opposed to Bongiorni et al., who used a regular stylet in their primary approach. The securing of the lead was enough in some cases to remove the lead with traction. If traction failed, we continued with the single sheath dilatation technique. The single sheath dilatation technique was used in the presence of exposed leads through the subclavian, cephalic or the jugular vein. We used polypropylene sheaths from Cook Medical, USA) or Spectranetics Corp. (Colorado Springs, USA). Most leads were extracted using 8.5- 11.5 F sheaths, in some cases 13F sheaths. In the St.Jude Medical Riata ICD lead cases, a larger sheath was selected due to externalization. In accordance with the technique described by Bongiorni et al.,
      • Bongiorni M.G.
      • Soldati E.
      • Zucchelli G.
      • et al.
      Transvenous removal of pacing and implantable cardiac defibrillating leads using single sheath mechanical dilatation and multiple venous approaches: high success rate and safety in more than 2000 leads.
      we changed to a larger sheath diameter when resistance was met and often switched back and forth between sheath sizes to overcome areas of strong adhesions. If impossible to pass one of the adhesions along the lead, we changed to MRS or snaring technique with transfemoral access (TFA) or internal transjugular access (ITA). When the lead was free floating (with no attachment to the entry site) from the beginning, or the lead broke during the procedure, the TFA or ITA approach as described by Bongiorni et al. was used.
      • Bongiorni M.G.
      • Segreti L.
      • Di Cori A.
      • et al.
      Safety and efficacy of internal transjugular approach for transvenous extraction of implantable cardioverter defibrillator leads.
      When the lead had grown into the clavicle, we used a steel sheath or the Cook Evolution ShortieTM. Procedure time was registered from skin incision until wound closure ("skin to skin") and includes re-implant in cases where that was performed in the same procedure. “Sheath time” was defined as the time the sheaths were being rotated or otherwise used actively to advance along the lead. If the sheath for some reason was left inside the patient for a short time while tracking out another lead or implanting a new lead, this time was not included in sheath time. Since 2010, all patients were examined immediately after the extraction procedure in the lab or in some cases in the cardiac intensive care unit with hand held echocardiography (V-scanTM) for pericardial effusion, while this was performed on clinical suspicion before 2010. Damage to the tricuspid valve was registered, although not actively examined for in all patients. If cardiac complications were suspected, or after difficult procedures, complete transthoracic echocardiography examination was performed. The extraction procedure has by large been unchanged during the 24 years period, except the increased use of MRS and some more use of anesthesia, especially in younger patients in recent years.

      Outcomes and definitions

      The primary outcome of our study was success rate as a measure of efficacy. The primary safety outcome was complication rate during hospital stay and up to 30-days.
      Procedural outcomes were defined according to radiological outcome, with complete success meaning removal of the entire lead. Partial success was defined as removal of all the lead except the distal 4 cm. Failure was defined as leaving a bigger fragment, total failure of removing the lead, or stopping the procedure because of a major complication.
      Complications occurring during TLE procedures or up to 30 days were registered consecutively and according to the classification published in the NASPE Policy Statement as outlined in supplementary table, S1.
      • Bongiorni M.G.
      • Soldati E.
      • Zucchelli G.
      • et al.
      Transvenous removal of pacing and implantable cardiac defibrillating leads using single sheath mechanical dilatation and multiple venous approaches: high success rate and safety in more than 2000 leads.
      If in doubt of which category the complications should be assigned to, the more serious one was chosen. If a valve injury indicated surgery, but contraindications led to observation, the complication was categorized as major. We had no permission to collect long-term follow up data. Only the most important complication in each patient was registered systematically.

      Statistics

      Continuous variables were reported as means with SD or medians with ranges according to data type and distribution. Kendall rank test was used to assess correlation (trend) between patient and procedure characteristics and ordinal categories of outcome. Students t-test, Wilcoxon rank-sum test or Fischer`s exact test were used according to data type and distribution to test differences in variables between two groups.
      Logistic regression analyses were used to assess relationship between characteristics of patients, procedures and outcome. Possible predictors were tested in univariate analysis, and significant predictors underwent multivariate logistic regression analyses with subsequent backward stepwise elimination of non-significant variables. Continuous variables with skewed distributions were divided into intervals to ease presentation of data, but sensitivity analyses were performed for all variables with skewed distribution after logarithmic transformation to ensure that results were in the similar range. If different results, logarithmic transformation of the skewed variable was chosen for regression analysis. Fischer`s exact test was used for categorical data to validate results from regression analysis because of few cases in some categories of outcome. A p value of ≤0.05 was considered significant for all tests. Analyses were performed using the JMP 9 (SAS Institute Inc., Cary, NC, USA) software.

      Ethics

      The local lead extraction registry was established with permission from the hospital data protection officer. Permission to publish anonymous data was given in September 2020 by the privacy officer on behalf of the hospital administration. The research reported in this paper adhered to the Helsinki Declaration

      Results

      Between April 1997 and throughout 2020, 1780 procedures were performed in 1642 patients. Of the 1642 patients, 120 had more than one TLE procedure. Because some patients had repeated procedures due to failed cases, the 1780 procedures represent 1768 unique patient cases. Main results are depicted in Figure 1. Main characteristics of patients, procedures and leads are shown in Table 1 and further according to level of technical success in Table 2 with further details provided in supplementary Tables S2-S4. Number of procedures, procedures with clinical success and failures per year are depicted in Figure 2. The median age of the patients was 65.0 (IQR = 20.00) years, and two thirds were male. Infection was the predominant indication during the first 5 years, reached a minimum of 27,9 % in 2013 and has accounted for 47.4% of TLE indiations from 2016 throughout 2020. Manual traction alone was used in 307 (17.2%) of procedures and 765 (25.8%) of leads were removed with manual traction alone. The median lead dwelling time was 5.0 years (IQR 7.0) while 685 leads had over 10 years, and 101 leads over 20 years dwelling time. The median procedure time 70 minutes (IQR 63)
      Figure thumbnail gr1
      Figure 1Main results in percentages of the total number of transvenous lead extraction procedures, Procedural outcome: Clinical success shown in green colour and failure in red. Complications: Major complications shown in red colour, minor- or observation in yellow and no complication in green.
      Table 1Patient-, procedure- and lead characteristics
      CharacteristicsAll procedures (n = 1780)
      Age, years median (IQR)65 (20)
      Male gender, n (%)1200 (67.4)
      Age at implant of oldest lead, years median (IQR)58 (22.5)
      Primary cardiac disease
      Primary electrical disease, n (%)‡819 (46.0)
      Coronary artery disease, n (%)496 ( 27.9)
      Dilated cardiomyopathy, n (%)203 (11.4)
      Valvular heart disease, n (%)126 (7.1)
      Congenital heart disease, n (%)100 (5.6)
      Hypertrophic cardiomyopathy, n (%)31 (1.7)
      Unclassified or no known heart disease, n (%)5 (0.3)
      Indication
      Sepsis/lead endocarditis, n (%)253 (14.2)
      Pocket infection, n (%)504 (28.4)
      Non-infection, n (%)§1022 (57.4)
      Left ventricular ejection fraction
      >50%, n (%)845 (47.5)
      30 – 50%, n (%)490 (27.5)
      <30%, n (%)222 (12.5)
      Unclassified or missing, n (%)223 (12.5)
      Lead characteristics
      Total, n2964
      Pacing leads, n (%)2085 (70.3)
      ICD leads, n (%)703 (23.7)
      Left ventricle - coronary sinus, n (%)132 (4.5)
      VDD, n (%)32 (1.1)
      SVC/array12 (0.4)
      Total, n2964
      Active fixation, screw n (%)1913 (64.5)
      Active fixation, tines n (%)849 (28.6)
      Passive fixation, unknown or other n (%)202 (6.8)
      Total, n2964
      Right atrium, n (%)1057 (35.7)
      Right ventricle, n (%)1739 (58.7)
      Coronary sinus and other, n (%)168 (5.7)
      Dwelling time, years
      Mean ± SD6.6 ± 5.4
      Median (IQR)5.0 (7.0)
      †Most important cardiac disease. Only the primary cardiac disease was registered for each individual. ‡Includes both conduction system disease and arrhythmia. IQR = Interquartile range § includes both absolute indications (e.g. occluded vein and need for venous access), the considered best clinical option, and relative indications (e.g. prophylactic extraction of recall leads, to avoid abandoned leads when system change or nonfunctioning lead) ¶Registered at first lead extraction procedure of each individual, not updated at repeated procedures.
      Table 2Procedure and lead characteristics according to level of technical success
      OutcomeComplete successPartial successFailureP
      Procedures, n = 1780n = 1669n = 70n = 41
      Age years, median (IQR)65.0 (19.0)65.5 (20.8)46.0 (37.0)0.0282
      Male, n (%)1136 (68.1)45 (64.3)19 (46.3)0.0201
      Infection, n (%)705 (42.2)36 (51.4)17 (41.5)ns
      Dwelling time oldest lead, years median (IQR)5.0 (6.0)8.5 (8.5)12 (13.5)<0.0001
      Procedure time, minutes median (IQR)†67.0 (60.0)108 (101.5)152.5 (126.5)<0.0001
      General anaesthesia, n (%)123 (7.4)8 (11.4)10 (24.4)0.0006
      Mechanical rotational sheaths, n (%)‡264 (15.8)15 (21.4)15 (36.6)<0.0001
      Snare, n (%)‡32 (1.9)13 (18.6)11 (26.8)<0.0001
      Major complication, n (% of procedures)15 (0.9)5 (7.1)3 (7.3)<0.0001
      Total number of leads to be removed, n = 2964275214270
      Leads completely removed, n (%)2752 (100.0)63 (44.4)26 (37.1)<0.0001
      † n = 1776, 4 missing. Time from skin incision until wound closure ("skin to skin"), including re-implant when performed in the same procedure.
      ‡number and % of procedures where this tool was used on at least one lead, P = p value from Kendall rank test, ns = not signifikant
      Figure thumbnail gr2
      Figure 2Number of transvenous lead extraction procedures each year. Total number shown in bars with blue borders. Number of transvenous lead extractions with achieved clinical success shown in green bars and number of failed transvenous lead extractions in red bars.
      Clinical success (complete or partial technical success) was achieved in 1739 procedures (97.7%) as shown in Table 2. Clinical success was achieved at repeated procedures in five patients with failure at first procedure, hence clinical success was achieved in 1732/1768 cases (98.0%).
      MRS were used since 2008 in 294 (16.5%) procedures, with increasing use in recent years. (Figure 3). The snaring technique was used in 56 (3.1%) TLE procedures with clinical success in 45 procedures (80.4%) (Table 2). TFA was used in 38 procedures, ITA in 21 procedures, and these two techniques combined in 15 procedures. In 12 procedures, where snaring from VES was applied, only one of these was combined with TFA.
      Figure thumbnail gr3
      Figure 3Number of transvenous lead extraction procedures each year involving specific extraction tools. Mechanical sheaths = Mechanical rotating dilator sheath (Cook EvolutionTM or Spectranetics TightRailTM) shown in blue. Steel sheaths shown in red and snaring in green. Polypropylene and locking stylets were used in most procedures and are not shown in this figure.
      General anaesthesia was given in less than 8% of the cases (Tables 2 and S5). These patients were younger, had older leads and more complex CIED history. Further characteristics according to method of anaesthesia are provided in Table S5. A cardiothoracic surgeon team was present on site from the start of the procedure in 8 TLE procedures only.
      Younger age, female gender, dwelling time of oldest lead, use of steel sheath and longer x-ray time were associated with procedure failure in multivariate analysis (Table S6).
      The type of leads (ICD or PM leads) was not associated with failure, nor with major complications (Tables S6 and S7). ICD leads had a mean dwelling time of 5.0 (IQR 4.0) years similar to other leads 5.0 (IQR 8.0 years).
      One ICD lead was subsequently removed successfully by open heart surgery in a younger patient, due to a free floating end and the potential risk of ventricular arrhythmias. Another ICD lead fragment was removed successfully later by open heart surgery due to infection. Success rate did not significantly vary with the level of operator experience, nor did complication rates (data not shown).

      Complications

      We had a total of 23 major complications (1.3 % of all procedures) over a period of 24 years, with one death only directly related to the TLE-procedure (0.06% mortality), and no caval tears as shown in Table 3. Two patients however died from sepsis within 24 hours after lead extraction, and one patient died from renal failure and sepsis within one week after TLE giving a total of four (0.23%) in hospital (while staying at our hospital after TLE) deaths. Of eleven patients needing open heart surgery (Table 3), four patients had immediate surgery due to cardiac tamponade. (There were no patients with tamponade needing open heart surgery between 2008 and end of 2020.) The most common major complication in recent years has been damage to the tricuspid valve. In total 14 cases of tricuspid valve injury were registered, and seven of these where considered being a major complication (Table 3). Some were not recognized immediately after the procedure, but on clinical suspicion murmur or other indication for echocardiography later in the course. Of the patients with tricuspid valve injury initially categorized as observation, one had a deterioration of heart failure secondary to damage of the valve, receiving a subsequent heart transplant months later. There were 32 complications classified as minor (1.8% of procedures), and 62 as observation (3.5%) as shown in Table 4. All minor complications and observations may, however, not have been registered, especially if occuring after discharge from our hospital. Detailed information about patient-, procedure- and lead characteristics according to complications are provided in supplementary tables S8 - S10. Female gender, dwelling time of oldest lead and longer procedure time were associated with major complications in multivariate analysis (Table S7).
      Table 3Major complications
      PatientYearOldest lead, yearsIndicationComplicationTreatmentOutcome
      1199923SepsisTamponadeDrainage, open heart surgery next dayRecovery
      2200215Pocket infectionTamponadeImmediate open heart surgeryDeath
      320042Pocket infectionRespiratory/Cardiac arrestCPRRecovery
      4200418Pocket infectionTamponadeImmediate open heart surgeryRecovery
      5200422Non-infectionTamponadeImmediate open heart surgeryRecovery
      620058Non-infectionTamponadeDrainageRecovery
      720083Non-infectionBronchospasmIntubation and inhalationsRecovery
      8200816Non-infectionTamponadeImmediate open heart surgeryRecovery
      9200917Pocket infectionValve injuryObservationMinimal symptoms
      10200923Non-infectionValve injuryOpen heart surgery,

      TVR
      Recovery
      1120103Pocket infectionPneumo-and haemothoraxChest tube and transfusionRecovery
      12201129Pocket infectionTamponadePericardial drainageRecovery†
      1320114Non-infectionRespiratory/Cardiac arrestCPRRecovery
      1420128Pocket infectionValve injuryOpen heart surgery, valve repairRecovery
      1520125Non-infectionValve injuryOpen heart surgery, valve repairRecovery
      16201411Non-infectionValve injury‡Open heart surgery, valve repairRecovery
      17201410Non-infectionValve injuryOpen heart surgery, TVR§Recovery
      1820159Non-infectionValve injuryOpen heart surgery, valve repairRecovery
      1920152Non-infectionPneumothoraxChest tubeRecovery
      2020156SepsisTamponadePericardial drainageRecovery
      2120166Non-infectionStrokeCerebral decompression and rehabilitationHemiparesis
      2220164SepsisStroke/TIAExamination, observationRecovery
      2320204Pocket infectionThoracic bleedingTransfusion and observationRecovery
      †Transient renal failure,
      ‡Detected two months after lead extraction due to gradually increasing dyspnoea,
      §Detected one week after lead extraction
      Table 4Minor- and observational complications
      2. Minor complications, n = 32
      Pericardial effusion not requiring pericardiocentesis or surgical intervention, n3
      Haemodynamically significant air embolism, n0
      Pulmonary embolism not requiring intervention, n3
      Vascular repair near the implant site or venous entry site, n0
      Arrhytmia requiring cardioversion/new conduction block and arrest requiring pacing, n6
      Haematoma at the pocket site requiring drainage, n10
      Arm swelling or trombosis of implant veins resulting in medical intervention, n9
      Sepsis in a previously non-septic patient with infection, n1
      Pacing system related infection of a previously non-infected site, n0
      3. Observation, n = 62
      Transient hypotension that responds to fluids or minor pharmacologic intervention, n17
      Non-significant air embolism, n0
      Small pneumothorax not requiring intervention, n2
      Ectopy not requiring cardioversion, n †4
      Arm swelling or trombosis of implant veins without need for medical intervention, n†2
      Pain at the cut-down site, n†0
      Myocardial avulsion without sequelae, n‡7
      Migrated lead fragment without sequelae, n1
      Haematoma not requiring drainage, n29
      n = number of procedures during/after which a particular compication occured.
      † less systematic registration.
      ‡ all of these were injuries to the tricuspid valve

      Discussion

      In this paper, we have reported the results of CIED lead extractions in 1780 patients in our high-volume center. Clinical success was achieved in 1739 procedures (97.7%). The rate of major complications was 1.3% and a mortality rate of 0.06%. Patients included in our registry were of similar age as in other TLE- reports, and about two thirds were male as also reported in other publications.
      • Bongiorni M.G.
      • Segreti L.
      • Di Cori A.
      • et al.
      Overcoming the current issues surrounding device leads: reducing the complications during extraction.
      Less than half of the procedures performed in our centre were done due to infection. This is somewhat lower than in the ELECTRA registry, but similar to the results from Brunner et al. 6, 15 Since we lack data on blood tests and co-morbidity and have incomplete registration of left ventricular ejection fraction and NYHA class, a more exact comparison between our population and other populations undergoing TLE will be inaccurate.
      Our procedural success rates are in line with results from other high volume centres.

      Deshmukh A, Patel N, Noseworthy PA, et al. Trends in Use and Adverse Outcomes Associated with Transvenous Lead Removal in the United States. Circulation. 2015132:2363-2371.

      ,
      • Bongiorni M.G.
      • Kennergren C.
      • Butter C.
      • et al.
      The European Lead Extraction ConTRolled (ELECTRa) study: a European Heart Rhythm Association (EHRA) Registry of Transvenous Lead Extraction Outcomes.
      ,
      • Bongiorni M.G.
      • Soldati E.
      • Zucchelli G.
      • et al.
      Transvenous removal of pacing and implantable cardiac defibrillating leads using single sheath mechanical dilatation and multiple venous approaches: high success rate and safety in more than 2000 leads.
      ,
      • Brunner M.P.
      • Cronin E.M.
      • Duarte V.E.
      • et al.
      Clinical predictors of adverse patient outcomes in an experience of more than 5000 chronic endovascular pacemaker and defibrillator lead extractions.
      ,

      Sood N, Martin DT, Lampert R, Curtis JP, Parzynski C, Clancy J. Incidence and Predictors of Perioperative Complications With Transvenous Lead Extractions: Real-World Experience With National Cardiovascular Data Registry. Circ Arrhythm Electrophysiol. 201811:e004768.

      We had a relatively conservative use of resources as general anaesthesia was confined to selected cases comprising less than eight percent of TLE procedures. Further, a cardiothoracic surgeon team on site and per operative echocardiography were used in exceptional cases only. We believe that our approach and use is cost-effective, although mainly using unpowered sheaths may increase procedure- and flourotimes, Our procedure-times were, however, shorter than in the Electra study and the study of Brunner et al. Unfortunately we lack exact data on costs.
      • Bongiorni M.G.
      • Kennergren C.
      • Butter C.
      • et al.
      The European Lead Extraction ConTRolled (ELECTRa) study: a European Heart Rhythm Association (EHRA) Registry of Transvenous Lead Extraction Outcomes.
      ,
      • Brunner M.P.
      • Cronin E.M.
      • Duarte V.E.
      • et al.
      Clinical predictors of adverse patient outcomes in an experience of more than 5000 chronic endovascular pacemaker and defibrillator lead extractions.
      In accordance with findings from other patient series, procedural failure was independently associated with young age and dwelling time of leads, probably due to more fibrotic adhesions around the leads, often also calcified.
      • Bongiorni M.G.
      • Segreti L.
      • Di Cori A.
      • et al.
      Overcoming the current issues surrounding device leads: reducing the complications during extraction.
      Further, female gender is known to increase risk of complications and was independently associated with both procedural failure and major complications in accordance with results from other studies.

      Deshmukh A, Patel N, Noseworthy PA, et al. Trends in Use and Adverse Outcomes Associated with Transvenous Lead Removal in the United States. Circulation. 2015132:2363-2371.

      ,

      Sood N, Martin DT, Lampert R, Curtis JP, Parzynski C, Clancy J. Incidence and Predictors of Perioperative Complications With Transvenous Lead Extractions: Real-World Experience With National Cardiovascular Data Registry. Circ Arrhythm Electrophysiol. 201811:e004768.

      ,
      • Zucchelli G.
      • Di Cori A.
      • Segreti L.
      • et al.
      Major cardiac and vascular complications aftertransvenous lead extraction: acute outcome and predictive factors from the ESC-EHRA ELECTRa (European Lead Extraction ConTRolled) registry.
      It seems that we had a higher threshold of converting to snaring and TFA or ITA approach than Bongiorni for example. Supplying sheath techniques with snaring with the TFA and ITA approach more often, may possibly have increased our success rates.
      • Bongiorni M.G.
      • Segreti L.
      • Di Cori A.
      • et al.
      Safety and efficacy of internal transjugular approach for transvenous extraction of implantable cardioverter defibrillator leads.
      Somewhat surprisingly, we did not find significant associations between success rates according to levels of the main operator’s level of experience. We believe this may be explained by two factors. Firstly, the most experienced operator was always available on site and could aid the less experienced colleague if necessary. Secondly, the presumed difficult cases were in general assigned to the more experienced cardiologist.
      There were only one directly procedure-related death and no caval tears during the 24 years. This appears to be similar to, or even lower than, in other registries and studies. Further, the rate of other major complications was in similar range as in other studies

      Deshmukh A, Patel N, Noseworthy PA, et al. Trends in Use and Adverse Outcomes Associated with Transvenous Lead Removal in the United States. Circulation. 2015132:2363-2371.

      ,
      • Bongiorni M.G.
      • Kennergren C.
      • Butter C.
      • et al.
      The European Lead Extraction ConTRolled (ELECTRa) study: a European Heart Rhythm Association (EHRA) Registry of Transvenous Lead Extraction Outcomes.
      ,
      • Bongiorni M.G.
      • Soldati E.
      • Zucchelli G.
      • et al.
      Transvenous removal of pacing and implantable cardiac defibrillating leads using single sheath mechanical dilatation and multiple venous approaches: high success rate and safety in more than 2000 leads.
      ,

      Kusumoto FM, Schoenfeld MH, Wilkoff BL, et al. 2017 HRS expert consensus statement on cardiovascular implantable electronic device lead management and extraction. Heart Rhythm. 2017 Sep 15.

      ,

      Sood N, Martin DT, Lampert R, Curtis JP, Parzynski C, Clancy J. Incidence and Predictors of Perioperative Complications With Transvenous Lead Extractions: Real-World Experience With National Cardiovascular Data Registry. Circ Arrhythm Electrophysiol. 201811:e004768.

      Potential differences in patient characteristics may as well explain minor differences in outcomes.
      Although all complications were systematically and consecutively registered during the stay in our hospitals, we cannot preclude that the rates of some complications may have been higher if systematic and targeted examinations for these complications had been undertaken.
      With increasing experience and better tools, one has experienced a reduction in the number of cases with cardiac tamponade.
      • Wazni O.
      • Wilkoff B.L.
      Considerations for cardiac device lead extraction.
      ,
      • Bongiorni M.G.
      • Kennergren C.
      • Butter C.
      • et al.
      The European Lead Extraction ConTRolled (ELECTRa) study: a European Heart Rhythm Association (EHRA) Registry of Transvenous Lead Extraction Outcomes.
      In recent years, we have registered some cases of damage to the tricuspid valve. Whether using MRS more and earlier in the procedure could reduce the incidence of valvular damages seems to be an unresolved question.
      • Ł Tułecki
      • Polewczyk A.
      • Jacheć W.
      • et al.
      Analysis of Risk Factors for Major Complications of 1500 Transvenous Lead Extraction Procedures with Especial Attention to Tricuspid Valve Damage.
      Our success- and complication rates are comparable with other high volume centers performing pacemaker and ICD lead extractions.
      • Wazni O.
      • Wilkoff B.L.
      Considerations for cardiac device lead extraction.
      ,
      • Bongiorni M.G.
      • Kennergren C.
      • Butter C.
      • et al.
      The European Lead Extraction ConTRolled (ELECTRa) study: a European Heart Rhythm Association (EHRA) Registry of Transvenous Lead Extraction Outcomes.
      Several factors may contribute to the relatively low complication rate in our center. These include careful use of the single sheath technique as described in methods as the primary TLE approach. Further, high centre volume, careful patient examination and evaluation, meticulous focus on reducing complications by all possible means and close supervision and guidance from experienced TLE cardiologists are likely to prevent complications. A relatively benign patient profile, mostly men, high proportion of active fixation leads and a relatively low mean dwelling time may also have influenced our results. However, we had a significant proportions of leads with dwelling time of more than 10 years. Recently the MRS Cook EvolutionTM and Spectranetics TightRailTM have become important supplementing extraction tools. 9, -, 21 Being more “aggressive” and effective than regular polypropylene or metal sheaths, concern has been raised regarding safety. Therefore, these tools are still not the first option in our center. Importantly, to reduce the risk of cardiac tear, the routine has been to switch back to polypropylene sheaths after passing an adherence, if possible. However, the use of MRS have increased since 2012 year in our center, and especially since 2017. Importantly, we used the PinVise TM (Cook medical) for improving grip and rotation on dilator sheaths until the PinViseTM was no longer available on the market after CE approval was not renewed August 2017. This rotational tool has so far not been replaced by any available tool of the same quality. Further, MRS have been more available and there is also increasing documentation for safety and efficacy of MRS, hence this change in policy.

      Resources and prevention of serious complications

      Many experts on CIED lead extractions today strongly advocate the use of intra procedural transoesophageal echocardiography. It has also been recommended placing a guide wire from the groin to the superior caval vein to enable immediate use of caval occluder balloon in case of a caval tear. Since we had no caval tears in 1780 procedures, we believe that placing a wire from the groin to the superior vena cava is not necessary in general. In many centers, lead extractions are also performed in general anaesthesia with thoracic surgeons on site. These preventive measures are costly, and we have achieved similar success- and safety rate without these measures.

      Strengths and limitations

      All patients needing a pacemaker- or ICD- lead extraction in our center have been registered consecutively and the data are complete for most parameters presented in this paper for almost all patients.
      Registration of co-morbidities has been less complete, and the registration of left ventricular function is missing in many patients. Further, left ventricular ejection fraction was registered for patients prior to their first extraction procedure and not updated for when repeated TLE. Blood tests and medication have not been registered. Data on chosen method of anaesthesia, steel sheaths, transoesophageal echocardiography and cardiothoracic surgeon back up on sight have been registered retrospectively.
      In the beginning of the transvenous extraction era at our hospital, there was mainly focus on cardiac tamponade as the major complication; hence, it is possible that some cases of asymptomatic tricuspid valve regurgitation have been missed. In addition, suboptimal quality of echocardiographic method/tools (hand held echocardiography-scanner, VscanTM) in many cases) may have underestimated the incidence of tricuspid valve damage.
      The most important limitation is the lack of systematic registration of outcome after the initial hospital admission, due to lack of permission to do so from the Norwegian legislation. Late complications, especially minor ones, may therefore be missed. Further, only the most serious complication for each patient was registered systematically.

      Conclusions

      Single sheath lead extraction supplied with snaring or mechanical rotational sheaths were effective and safe in our high volume center with experienced operators.

      Data availability

      Anonymized data supporting the findings of this study are available from the corresponding author on request.

      Uncited reference

      • Witte O.A.
      • Adiyaman A.
      • Smit J.J.J.
      • et al.
      Success and complication rates of lead extraction with the first- vs. the second-generation Evolution mechanical sheath.
      ,
      • Bongiorni M.G.
      • Di Cori A.
      • Segreti L.
      • et al.
      Where is the future of cardiac lead extraction heading?.
      ,

      Starck CT, Gonzales E, Al-Razzo O, et al. Results of the Patient-Related Outcomes of Mechanical lead Extraction Techniques (PROMET) study: a multicentre retrospective study on advanced mechanical lead extraction techniques. Europace 2020;227:1103-1110

      .

      Acknowledgements

      None
      Funding
      This research did not receive any specific grant from funding agencies in the public, commercial, or not-for-profit sectors.

      Supplementary material

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