Analysis of complications of transvenous extraction of electrodes of cardiac implantable devices

Introduction. The widespread use of cardiac implantable electronic devices (CIEDs) has led to a natural increase in the number of patients requiring transvenous lead extraction (TLE) due to infectious complications and system dysfunction. Despite refined techniques, TLE remains a procedure with a risk of life-threatening complications, such as cardiac perforation or major vein rupture, with an associated mortality rate of up to 50%. Several predictive risk scores (MB Score, LED Score, SAFeTY Score, EROS) have been proposed for risk stratification; however, there is no unified consensus regarding their applicability, diagnostic value, or the most significant predictors.

Objective. To conduct a comparative analysis of the prognostic value of existing risk scores (MB Score, LED Score, SAFeTY Score, EROS) and to identify independent predictors of major intraoperative complications during transvenous lead extraction (TLE).

Materials and Methods. A multicenter retrospective study included 300 patients who underwent TLE between 2019 and 2023. All patients underwent preoperative risk stratification using four prognostic risk scores. Statistical analysis included correlation analysis (Spearman's coefficient) and ROC analysis. To assess the independent effect of predictors on the development of major complications, binary logistic regression with forward stepwise selection was used.

Results. Major complications were recorded in 11 (3.7%) patients. A statistically significant positive correlation was found between the development of complications and scores on the MB Score (r=0.156; p=0.007), LED Score (r=0.155; p=0.007), and SAFeTY Score (r=0.13; p=0.024), and EROS Score (r=0.134; p=0.021). ROC analysis demonstrated that the MB Score (AUC 0.737; p=0.008) and LED Score (AUC 0.739; p=0.007) had the best diagnostic performance; SAFeTY Score showed moderate predictive quality (AUC 0.699; p=0.025), while EROS Score showed borderline statistical significance (AUC 0.673; p=0.051). ROC analysis identified additional factors associated with complications: lead age > 126 months, infection duration > 4.5 months, eGFR < 73 mL/min, female sex, diabetes mellitus, passive lead fixation, and the presence of cut or fractured leads. In stepwise logistic regression of the four risk scores, only LED Score was included in the final model (OR=1.087; 95% CI: 1.019–1.159; p=0.011). When the additional factors were tested in the multivariate model, only infection duration > 4.5 months retained independent significance (OR=4.114; 95% CI: 1.120–15.109; p=0.033). Female sex showed a trend toward significance (p=0.056). The remaining factors lost their prognostic significance after adjustment.

Conclusion: TLE is a safe and effective method with a major complication rate of 3.7%. LED Score is the most informative prognostic scale, and infection duration > 4.5 months is an additional independent predictor of complications, supporting the need for timely referral of patients for surgical treatment. Consideration of these factors improves perioperative risk stratification and optimizes the choice of surgical strategy.

1. Ayvazyan S.A., Artyukhina E.A., Gureev S.V., et al. Transvenous lead extraction of cardiac implantable electronic devices: indications, techniques, equipment, patient management. Ed. by Academician of RAS A.Sh. Revishvili. Moscow: Vidar-M Publishing House; 2021. 144 p. (In Russ.)

2. Sapelnikov O.V., Kulikov A.A., Cherkashin D.I., Grishin I.R., Nikolaeva O.A., Ardus D.F., Shiryaev A.A., Akchurin R.S. Removal of electrodes of implanted systems. The state of the problem. Patologiya krovoobrashcheniya i kardiokhirurgiya=Circulation Pathology and Cardiac Surgery. 2019;23(4):47-52. (In Russ.) https://doi.org/10.21688/1681-3472-2019-4-47-52

3. Bontempi L, Vassanelli F, Cerini M, D'Aloia A, Vizzardi E, Gargaro A, Chiusso F, Mamedouv R, Lipari A, Curnis A. Predicting the difficulty of a lead extraction procedure: the LED index. J Cardiovasc Med (Hagerstown). 2014 Aug;15(8):668-73. PMID: 24850500. https://doi.org/10.2459/JCM.0000000000000023

4. Bontempi L, Curnis A, Della Bella P, Cerini M, Radinovic A, Inama L, Melillo F, Salghetti F, Marzi A, Gargaro A, Giacopelli D, Mazzone P. The MB score: a new risk stratification index to predict the need for advanced tools in lead extraction procedures. Europace. 2020 Apr 1;22(4):613-621. PMID: 32087025. https://doi.org/10.1093/europace/euaa027

5. Sidhu BS, Ayis S, Gould J, Elliott MK, Mehta V, Kennergren C, Butter C, Deharo JC, Kutarski A, Maggioni AP, Auricchio A, Kuck KH, Blomström-Lundqvist C, Bongiorni MG, Rinaldi CA; ELECTRa Investigators Group. Risk stratification of patients undergoing transvenous lead extraction with the ELECTRa Registry Outcome Score (EROS): an ESC EHRA EORP European lead extraction ConTRolled ELECTRa registry analysis. Europace. 2021 Sep 8;23(9):1462-1471. PMID: 33615342. https://doi.org/10.1093/europace/euab037

6. Jacheć W, Polewczyk A, Polewczyk M, Tomasik A, Kutarski A. Transvenous Lead Extraction SAFeTY Score for Risk Stratification and Proper Patient Selection for Removal Procedures Using Mechanical Tools. J Clin Med. 2020 Jan 28;9(2):361. PMID: 32013032; PMCID: PMC7073714. https://doi.org/10.3390/jcm9020361

7. Aivazian S.A., Sapelnikov O.V., Grishin I.R., Sorokin I.N. Lead extraction risk scores and practical use: literature review. Journal of Arrhythmology. 2022;29(2):50-57. (In Russ.) https://doi.org/10.35336/VA-2022-2-05

8. Ayvazyan SA, Grishin IR, Emelyanov AV, et al. Method for removing endocardial electrodes under the videothoracoscopy control in patients with a high risk of damage superior vena cava system. Patent RU 2743616 C1. 2021 Feb 20. (In Russ.)

9. Bongiorni MG, Kennergren C, Butter C, Deharo JC, Kutarski A, Rinaldi CA, Romano SL, Maggioni AP, Andarala M, Auricchio A, Kuck KH, Blomström-Lundqvist C; ELECTRa Investigators. The European Lead Extraction ConTRolled (ELECTRa) study: a European Heart Rhythm Association (EHRA) Registry of Transvenous Lead Extraction Outcomes. Eur Heart J. 2017 Oct 21;38(40):2995-3005. PMID: 28369414. https://doi.org/10.1093/eurheartj/ehx080

10. Wazni O, Epstein LM, Carrillo RG, Love C, Adler SW, Riggio DW, Karim SS, Bashir J, Greenspon AJ, DiMarco JP, Cooper JM, Onufer JR, Ellenbogen KA, Kutalek SP, Dentry-Mabry S, Ervin CM, Wilkoff BL. Lead extraction in the contemporary setting: the LExICon study: an observational retrospective study of consecutive laser lead extractions. J Am Coll Cardiol. 2010 Feb 9;55(6):579-86. Erratum in: J Am Coll Cardiol. 2010 Mar 9;55(10):1055. PMID: 20152562. https://doi.org/10.1016/j.jacc.2009.08.070

11. 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, Hakmi S. The GermAn Laser Lead Extraction RegistrY: GALLERY. Europace. 2022 Oct 13;24(10):1627-1635. https://doi.org/10.1093/europace/euac056. Erratum in: Europace. 2023 May 19;25(5):euac171. https://doi.org/10.1093/europace/euac171. Erratum in: Europace. 2022 Oct 13;24(10):1635. PMID: 35718878. https://doi.org/10.1093/europace/euac133

12. Hosseini SM, Rozen G, Kaadan MI, Galvin J, Ruskin JN. Safety and In-Hospital Outcomes of Transvenous Lead Extraction for Cardiac Implantable Device-Related Infections: Analysis of 13 Years of Inpatient Data in the United States. JACC Clin Electrophysiol. 2019 Dec;5(12):1450-1458. Epub 2019 Oct 30. PMID: 31857046. https://doi.org/10.1016/j.jacep.2019.08.020

13. Endo Y, O'Mara JE, Weiner S, Han J, Goldberger MH, Gordon GM, Nanna M, Ferrick KJ, Gross JN. Clinical utility of intraprocedural transesophageal echocardiography during transvenous lead extraction. J Am Soc Echocardiogr. 2008 Jul;21(7):861-7. Epub 2008 Mar 4. PMID: 18313266. https://doi.org/10.1016/j.echo.2008.01.006

14. Tułecki Ł, Polewczyk A, Jacheć W, Nowosielecka D, Tomków K, Stefańczyk P, Kosior J, Duda K, Polewczyk M, Kutarski A. Analysis of Risk Factors for Major Complications of 1500 Transvenous Lead Extraction Procedures with Especial Attention to Tricuspid Valve Damage. Int J Environ Res Public Health. 2021 Aug 28;18(17):9100. PMID: 34501689; PMCID: PMC8431163. https://doi.org/10.3390/ijerph18179100

15. Lin AY, Saul T, Aldaas OM, Lupercio F, Ho G, Pollema T, Pretorius V, Birgersdotter-Green U. Early Versus Delayed Lead Extraction in Patients With Infected Cardiovascular Implantable Electronic Devices. JACC Clin Electrophysiol. 2021 Jun;7(6):755-763. Epub 2020 Dec 24. PMID: 33358664; PMCID: PMC8209117. https://doi.org/10.1016/j.jacep.2020.11.003

16. Viganego F, O'Donoghue S, Eldadah Z, Shah MH, Rastogi M, Mazel JA, Platia EV. Effect of early diagnosis and treatment with percutaneous lead extraction on survival in patients with cardiac device infections. Am J Cardiol. 2012 May 15;109(10):1466-71. Epub 2012 Feb 21. PMID: 22356796. https://doi.org/10.1016/j.amjcard.2012.01.360

17. Bongiorni MG, Burri H, Deharo JC, Starck C, Kennergren C, Saghy L, Rao A, Tascini C, Lever N, Kutarski A, Fernandez Lozano I, Strathmore N, Costa R, Epstein L, Love C, Blomstrom-Lundqvist C; ESC Scientific Document Group. 2018 EHRA expert consensus statement on lead extraction: recommendations on definitions, endpoints, research trial design, and data collection requirements for clinical scientific studies and registries: endorsed by APHRS/ HRS/LAHRS. Europace. 2018 Jul 1;20(7):1217. doi: 10.1093/europace/euy050. Erratum in: Europace. 2018 Jul 1;20(7):1167. PMID: 29566158. https://doi.org/10.1093/europace/euy070