##common.pageHeaderLogo.altText##

Original article

Vol. 155 No. 7 (2025)

Local diagnostic reference levels for cardiac implantable electronic device procedures: data from a tertiary care centre

Cite this as:
Swiss Med Wkly. 2025;155:4053
Published
17.07.2025

Summary

AIM: To establish local diagnostic reference levels for cardiac implantable electronic device procedures and to compare local practice with national guidelines.

METHODS: A retrospective cohort study including all consecutive patients from October 2018 to October 2020 who underwent implantation of a cardiac implantable electronic device including pacemaker, implantable cardioverter defibrillator (ICD), cardiac resynchronisation therapy (CRT) or lead extraction / device explantation. Data was collected from a dose management system and cross-checked for accuracy with the patient information system. The pre-specified outcome was patient radiation exposure, evaluated with the kerma area product (KAP), cumulative dose, fluoroscopy time and number of cine acquisitions. The median values were set as local diagnostic reference levels.

RESULTS: A total of 541 patients were included. 28.3% had a conventional pacemaker, 22.0% a leadless pacemaker, 21.1% an ICD and 17.2% a CRT implanted, while lead extraction / device explantation was performed in 11.5% of patients. The local diagnostic reference levels for the kerma area product were lower than the national Swiss diagnostic reference levels (0.4 Gray [Gy]∙cm2 vs 30 Gy∙cm2 for conventional pacemakers; 0.4 Gy∙cm2 vs 20 Gy∙cm2 for ICDs; 10.2 Gy∙cm2 vs 57 Gy cm2 for CRTs). Similarly, the local diagnostic reference levels for cumulative dose and fluoroscopy time were below national diagnostic reference levels.

CONCLUSIONS: Local diagnostic reference levels values were far below national diagnostic reference levels. A multicentre approach to assess patient radiation exposure in current practice is strongly desired to establish revised national diagnostic reference levels.

References

  1. Raatikainen MJ, Arnar DO, Zeppenfeld K, Merino JL, Levya F, Hindriks G, et al. Statistics on the use of cardiac electronic devices and electrophysiological procedures in the European Society of Cardiology countries: 2014 report from the European Heart Rhythm Association. Europace. 2015 Jan;17 Suppl 1:i1–75. doi: https://doi.org/10.1093/europace/euu300
  2. Report N. 184 – Medical Radiation Exposure of Patients in the United States (2019). National Council on Radiation Protection and Measurements. 2019.
  3. Heidbuchel H, Wittkampf FH, Vano E, Ernst S, Schilling R, Picano E, et al. Practical ways to reduce radiation dose for patients and staff during device implantations and electrophysiological procedures. Europace. 2014 Jul;16(7):946–64. doi: https://doi.org/10.1093/europace/eut409
  4. Picano E, Vañó E, Rehani MM, Cuocolo A, Mont L, Bodi V, et al. The appropriate and justified use of medical radiation in cardiovascular imaging: a position document of the ESC Associations of Cardiovascular Imaging, Percutaneous Cardiovascular Interventions and Electrophysiology. Eur Heart J. 2014 Mar;35(10):665–72. doi: https://doi.org/10.1093/eurheartj/eht394
  5. Fazel R, Krumholz HM, Wang Y, Ross JS, Chen J, Ting HH, et al. Exposure to low-dose ionizing radiation from medical imaging procedures. N Engl J Med. 2009 Aug;361(9):849–57. doi: https://doi.org/10.1056/NEJMoa0901249
  6. Gerber TC, Carr JJ, Arai AE, Dixon RL, Ferrari VA, Gomes AS, et al. Ionizing radiation in cardiac imaging: a science advisory from the American Heart Association Committee on Cardiac Imaging of the Council on Clinical Cardiology and Committee on Cardiovascular Imaging and Intervention of the Council on Cardiovascular Radiology and Intervention. Circulation. 2009 Feb;119(7):1056–65. doi: https://doi.org/10.1161/CIRCULATIONAHA.108.191650
  7. Vañó E, Miller DL, Martin CJ, Rehani MM, Kang K, Rosenstein M, et al.; Authors on behalf of ICRP. ICRP Publication 135: Diagnostic Reference Levels in Medical Imaging. Ann ICRP. 2017 Oct;46(1):1–144. doi: https://doi.org/10.1177/0146645317717209
  8. Council of the European Union. Council Directive 2013/59/EURATOM. Official Journal of the European Union. 2013. Availabe from: https://eur-lex.europa.eu/eli/dir/2013/59/oj/eng
  9. Sazgary L, Samara ET, Stüssi A, Saltybaeva N, Guckenberger M, Ruschitzka F, et al. Impact of clinical radiation audits on patient radiation exposure in cardiac implantable electronic device procedures. Heart Rhythm. 2024 Oct;21(10):2046–7. doi: https://doi.org/10.1016/j.hrthm.2024.04.060
  10. The 2007 Recommendations of the International Commission on Radiological Protection. ICRP publication 103. Ann ICRP. 2007;37(2-4):1–332.
  11. Damilakis J, Frija G, Brkljacic B, Vano E, Loose R, Paulo G, et al.; European Society of Radiology. How to establish and use local diagnostic reference levels: an ESR EuroSafe Imaging expert statement. Insights Imaging. 2023 Feb;14(1):27. doi: https://doi.org/10.1186/s13244-023-01369-x
  12. Swiss Federal Office of Public Health (FOPH). Diagnostische Referenzwerte (DRW) für interventionelle radiologische Anwendungen. BAG. 2018. Wegleitung R-06-05. p.1–5. Availabe from: https://www.bag.admin.ch/bag/de/home/gesetze-und-bewilligungen/gesuche-bewilligungen/bewilligungen-aufsicht-im-strahlenschutz/informationen-fuer-medizinische-betriebe/diagnostische-referenzwerte-im-strahlenschutz.html
  13. Casella M, Dello Russo A, Russo E, Catto V, Pizzamiglio F, Zucchetti M, et al. X-Ray Exposure in Cardiac Electrophysiology: A Retrospective Analysis in 8150 Patients Over 7 Years of Activity in a Modern, Large-Volume Laboratory. J Am Heart Assoc. 2018 May;7(11):e008233. doi: https://doi.org/10.1161/JAHA.117.008233
  14. Bork FT, Boehmer AA, Zezyk C, Kaess BM, Ehrlich JR. Frame-rate reduction to reduce radiation dose for cardiac device implantation is safe. Heart Rhythm O2. 2023 May;4(7):427–32. doi: https://doi.org/10.1016/j.hroo.2023.05.003
  15. Thibault B, Andrade JG, Dubuc M, Talajic M, Guerra PG, Dyrda K, et al. Reducing radiation exposure during CRT implant procedures: early experience with a sensor-based navigation system. Pacing Clin Electrophysiol. 2015 Jan;38(1):63–70. doi: https://doi.org/10.1111/pace.12522
  16. Haeberlin A, Kozhuharov N, Knecht S, Tanner H, Schaer B, Noti F, et al. Leadless pacemaker implantation quality: importance of the operator’s experience. Europace. 2020 Jun;22(6):939–46. doi: https://doi.org/10.1093/europace/euaa097