{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,4]],"date-time":"2026-09-04T05:03:15Z","timestamp":1788498195634,"version":"build-2803163510"},"reference-count":28,"publisher":"MDPI AG","issue":"14","license":[{"start":{"date-parts":[[2026,7,22]],"date-time":"2026-07-22T00:00:00Z","timestamp":1784678400000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/501100004329","name":"The Slovenian Research and Innovation Agency","doi-asserted-by":"publisher","award":["P3-0457"],"award-info":[{"award-number":["P3-0457"]}],"id":[{"id":"10.13039\/501100004329","id-type":"DOI","asserted-by":"publisher"}]},{"award":["P3-0457"],"award-info":[{"award-number":["P3-0457"]}],"id":[{"id":"https:\/\/ror.org\/059bp8k51","id-type":"ROR","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["J. Clin. Med.","JCM"],"abstract":"<jats:p>Background\/Objectives: The increasing use of cardiovascular implantable electronic devices has increased the need for transvenous lead extraction (TLE), which carries a relevant complication risk. The SAFeTY score was developed to predict procedure-related major complications. We evaluated TLE outcomes, explored associations between the SAFeTY score and retrospective endpoints, and compared conventional extraction (CE) with mechanical rotational sheath-assisted extraction (MRSE). Methods: This retrospective study included consecutive patients undergoing TLE at a tertiary center between 2015 and 2025. The SAFeTY score was calculated in patients undergoing MRSE and examined in relation to procedure-related and all-cause in-hospital mortality, significant post-procedural hemoglobin decrease, and a composite endpoint. Results: Among 314 patients, 193 (61.5%) underwent MRSE. These patients had longer cumulative lead dwell time and more previous procedures, indicating greater procedural complexity. Overall procedural success was 95.9%, procedure-related mortality was 0.3%, and all-cause in-hospital mortality was 4.8%. Exploratory unadjusted comparisons showed no significant differences between MRSE and CE in procedural success or mortality. In the MRSE group, 17.1% had a post-procedural hemoglobin decrease &gt; 30 g\/L. The SAFeTY score was not associated with procedure-related or all-cause mortality but was associated with the composite endpoint (odds ratio 1.12 per point, p = 0.025), with modest discrimination (area under the receiver operating characteristic curve [AUC] 0.59). Conclusions: TLE achieved high procedural success and very low procedure-related mortality. Because MRSE was non-randomly selected for more complex procedures, the study cannot establish equivalence or an independent effect of extraction strategy. Associations between the SAFeTY score and alternative retrospective endpoints should be considered exploratory and do not constitute validation for its original purpose.<\/jats:p>","DOI":"10.3390\/jcm15145745","type":"journal-article","created":{"date-parts":[[2026,7,22]],"date-time":"2026-07-22T10:48:28Z","timestamp":1784717308000},"page":"5745","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":1,"title":["Transvenous Lead Extraction in a Real-World Cohort: Clinical Characteristics, Outcomes, and Performance of the SAFeTY Score"],"prefix":"10.3390","volume":"15","author":[{"given":"Mark","family":"Racman","sequence":"first","affiliation":[{"name":"Department of Cardiovascular Surgery, University Medical Centre Ljubljana, Zaloska 7, 1000 Ljubljana, Slovenia"},{"name":"Faculty of Medicine, University of Ljubljana, 1000 Ljubljana, Slovenia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Aida","family":"Duric","sequence":"additional","affiliation":[{"name":"Department of Cardiovascular Surgery, University Medical Centre Ljubljana, Zaloska 7, 1000 Ljubljana, Slovenia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0003-4159-1783","authenticated-orcid":false,"given":"Jan","family":"Kafol","sequence":"additional","affiliation":[{"name":"Faculty of Medicine, University of Ljubljana, 1000 Ljubljana, Slovenia"},{"name":"Department of Vascular Diseases, Division of Internal Medicine, University Medical Centre Ljubljana, 1000 Ljubljana, Slovenia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jan","family":"Prevolnik","sequence":"additional","affiliation":[{"name":"Department of Cardiovascular Surgery, University Medical Centre Ljubljana, Zaloska 7, 1000 Ljubljana, Slovenia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jus","family":"Ksela","sequence":"additional","affiliation":[{"name":"Department of Cardiovascular Surgery, University Medical Centre Ljubljana, Zaloska 7, 1000 Ljubljana, Slovenia"},{"name":"Faculty of Medicine, University of Ljubljana, 1000 Ljubljana, Slovenia"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1968","published-online":{"date-parts":[[2026,7,22]]},"reference":[{"key":"ref_1","doi-asserted-by":"crossref","first-page":"88","DOI":"10.1016\/j.jacep.2021.06.006","article-title":"Trends in Cardiovascular Implantable Electronic Device Insertion Between 1988 and 2018 in Olmsted County","volume":"8","author":"Vaidya","year":"2022","journal-title":"JACC Clin. Electrophysiol."},{"key":"ref_2","doi-asserted-by":"crossref","first-page":"1217","DOI":"10.1093\/europace\/euy050","article-title":"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","volume":"20","author":"Bongiorni","year":"2018","journal-title":"Europace"},{"key":"ref_3","doi-asserted-by":"crossref","first-page":"e503","DOI":"10.1016\/j.hrthm.2017.09.001","article-title":"2017 HRS expert consensus statement on cardiovascular implantable electronic device lead management and extraction","volume":"14","author":"Kusumoto","year":"2017","journal-title":"Heart Rhythm"},{"key":"ref_4","doi-asserted-by":"crossref","first-page":"e004768","DOI":"10.1161\/CIRCEP.116.004768","article-title":"Incidence and Predictors of Perioperative Complications with Transvenous Lead Extractions: Real-World Experience with National Cardiovascular Data Registry","volume":"11","author":"Sood","year":"2018","journal-title":"Circ. Arrhythm. Electrophysiol."},{"key":"ref_5","doi-asserted-by":"crossref","unstructured":"Boarescu, P.M., Rosian, A.N., and Rosian, S.H. (2022). Transvenous Lead Extraction Procedure-Indications, Methods, and Complications. Biomedicines, 10.","DOI":"10.3390\/biomedicines10112780"},{"key":"ref_6","doi-asserted-by":"crossref","first-page":"2995","DOI":"10.1093\/eurheartj\/ehx080","article-title":"The European Lead Extraction ConTRolled (ELECTRa) study: A European Heart Rhythm Association (EHRA) Registry of Transvenous Lead Extraction Outcomes","volume":"38","author":"Bongiorni","year":"2017","journal-title":"Eur. Heart J."},{"key":"ref_7","doi-asserted-by":"crossref","first-page":"181","DOI":"10.1016\/j.hrthm.2022.10.004","article-title":"Transvenous lead extraction in patients with systemic cardiac device-related infection-Procedural outcome and risk prediction: A GALLERY subgroup analysis","volume":"20","author":"Chung","year":"2023","journal-title":"Heart Rhythm"},{"key":"ref_8","doi-asserted-by":"crossref","first-page":"557","DOI":"10.1007\/s10840-024-01891-y","article-title":"Trends and outcomes of inpatient cardiac implantable electronic device transvenous lead extractions: A nationwide analysis","volume":"68","author":"Khalil","year":"2025","journal-title":"J. Interv. Card. Electrophysiol."},{"key":"ref_9","doi-asserted-by":"crossref","first-page":"1718","DOI":"10.1093\/europace\/euaa131","article-title":"The effect of centre volume and procedure location on major complications and mortality from transvenous lead extraction: An ESC EHRA EORP European Lead Extraction ConTRolled ELECTRa registry subanalysis","volume":"22","author":"Sidhu","year":"2020","journal-title":"Europace"},{"key":"ref_10","doi-asserted-by":"crossref","unstructured":"Tulecki, L., Polewczyk, A., Jachec, W., Nowosielecka, D., Tomkow, K., Stefanczyk, P., Kosior, J., Duda, K., Polewczyk, M., and Kutarski, A. (2021). 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, 18.","DOI":"10.3390\/ijerph18179100"},{"key":"ref_11","doi-asserted-by":"crossref","first-page":"8796704","DOI":"10.1155\/2018\/8796704","article-title":"Risk Factors Predicting Complications of Transvenous Lead Extraction","volume":"2018","author":"Jachec","year":"2018","journal-title":"BioMed Res. Int."},{"key":"ref_12","doi-asserted-by":"crossref","unstructured":"Jachec, W., Polewczyk, A., Polewczyk, M., Tomasik, A., and Kutarski, A. (2020). Transvenous Lead Extraction SAFeTY Score for Risk Stratification and Proper Patient Selection for Removal Procedures Using Mechanical Tools. J. Clin. Med., 9.","DOI":"10.3390\/jcm9020361"},{"key":"ref_13","doi-asserted-by":"crossref","first-page":"e062952","DOI":"10.1136\/bmjopen-2022-062952","article-title":"Assessment of the impact of organisational model of transvenous lead extraction on the effectiveness and safety of procedure: An observational study","volume":"12","author":"Tulecki","year":"2022","journal-title":"BMJ Open"},{"key":"ref_14","doi-asserted-by":"crossref","first-page":"395","DOI":"10.1093\/icvts\/ivaa286","article-title":"Transvenous lead extraction outcomes using a novel hand-powered bidirectional rotational sheath as a first-line extraction tool in a low-volume centre","volume":"32","author":"Ksela","year":"2021","journal-title":"Interact. Cardiovasc. Thorac. Surg."},{"key":"ref_15","doi-asserted-by":"crossref","first-page":"2403","DOI":"10.1093\/eurheartj\/ehs255","article-title":"Updated standardized endpoint definitions for transcatheter aortic valve implantation: The Valve Academic Research Consortium-2 consensus document","volume":"33","author":"Kappetein","year":"2012","journal-title":"Eur. Heart J."},{"key":"ref_16","doi-asserted-by":"crossref","first-page":"2736","DOI":"10.1161\/CIRCULATIONAHA.110.009449","article-title":"Standardized bleeding definitions for cardiovascular clinical trials: A consensus report from the Bleeding Academic Research Consortium","volume":"123","author":"Mehran","year":"2011","journal-title":"Circulation"},{"key":"ref_17","doi-asserted-by":"crossref","first-page":"51","DOI":"10.1016\/j.amjcard.2022.04.022","article-title":"Patient Characteristics, Procedural Characteristics, and Outcomes in Patients Having Lead Extraction in a High-Volume Center","volume":"176","author":"Schmidt","year":"2022","journal-title":"Am. J. Cardiol."},{"key":"ref_18","doi-asserted-by":"crossref","first-page":"263","DOI":"10.1016\/j.ipej.2024.07.001","article-title":"Long- and short-term outcomes after transvenous lead extraction in a large single-centre patient cohort using the clinical frailty scale as a risk assessment tool","volume":"24","author":"Azari","year":"2024","journal-title":"Indian Pacing Electrophysiol. J."},{"key":"ref_19","doi-asserted-by":"crossref","first-page":"euad214","DOI":"10.1093\/europace\/euad214","article-title":"Long-term survival following transvenous lead extraction: Unpicking differences according to sex","volume":"25","author":"Mehta","year":"2023","journal-title":"Europace"},{"key":"ref_20","first-page":"69","article-title":"Trends of Sex Differences in Outcomes of Cardiac Electronic Device Implantations in the United States","volume":"36","author":"Mohamed","year":"2020","journal-title":"Can. J. Cardiol."},{"key":"ref_21","doi-asserted-by":"crossref","first-page":"1103","DOI":"10.1093\/europace\/euaa103","article-title":"Results of the Patient-Related Outcomes of Mechanical lead Extraction Techniques (PROMET) study: A multicentre retrospective study on advanced mechanical lead extraction techniques","volume":"22","author":"Starck","year":"2020","journal-title":"Europace"},{"key":"ref_22","doi-asserted-by":"crossref","first-page":"436","DOI":"10.1111\/pace.15146","article-title":"Multicentric Experience with the Use of Short 13Fr Mechanical Rotating Dilator Sheath for Transvenous Lead Extraction","volume":"48","author":"Preda","year":"2025","journal-title":"Pacing Clin. Electrophysiol."},{"key":"ref_23","doi-asserted-by":"crossref","first-page":"1218","DOI":"10.1093\/europace\/eut410","article-title":"Predictors of 30-day and 1-year mortality after transvenous lead extraction: A single-centre experience","volume":"16","author":"Deckx","year":"2014","journal-title":"Europace"},{"key":"ref_24","doi-asserted-by":"crossref","first-page":"520","DOI":"10.1016\/j.hrthm.2008.01.009","article-title":"Large, single-center, single-operator experience with transvenous lead extraction: Outcomes and changing indications","volume":"5","author":"Jones","year":"2008","journal-title":"Heart Rhythm"},{"key":"ref_25","doi-asserted-by":"crossref","first-page":"14864","DOI":"10.1038\/s41598-021-94168-7","article-title":"Influence of the type of pathogen on the clinical course of infectious complications related to cardiac implantable electronic devices","volume":"11","author":"Polewczyk","year":"2021","journal-title":"Sci. Rep."},{"key":"ref_26","doi-asserted-by":"crossref","first-page":"1627","DOI":"10.1093\/europace\/euac056","article-title":"The GermAn Laser Lead Extraction RegistrY: GALLERY","volume":"24","author":"Pecha","year":"2022","journal-title":"Europace"},{"key":"ref_27","doi-asserted-by":"crossref","first-page":"278","DOI":"10.1111\/jce.16147","article-title":"Safety and feasibility of same-day discharge following uncomplicated transvenous lead extraction","volume":"35","author":"Gianni","year":"2024","journal-title":"J. Cardiovasc. Electrophysiol."},{"key":"ref_28","doi-asserted-by":"crossref","first-page":"euad316","DOI":"10.1093\/europace\/euad316","article-title":"Comparison of non-laser and laser transvenous lead extraction: A systematic review and meta-analysis","volume":"25","author":"Akhtar","year":"2023","journal-title":"Europace"}],"container-title":["Journal of Clinical Medicine"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/www.mdpi.com\/2077-0383\/15\/14\/5745\/pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,7,22]],"date-time":"2026-07-22T11:30:18Z","timestamp":1784719818000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.mdpi.com\/2077-0383\/15\/14\/5745"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,7,22]]},"references-count":28,"journal-issue":{"issue":"14","published-online":{"date-parts":[[2026,7]]}},"alternative-id":["jcm15145745"],"URL":"https:\/\/doi.org\/10.3390\/jcm15145745","relation":{},"ISSN":["2077-0383"],"issn-type":[{"value":"2077-0383","type":"electronic"}],"subject":[],"published":{"date-parts":[[2026,7,22]]}}}