title: Safety and efficacy of applying a low-dose radiation fluoroscopy protocol in device implantations.
abstract: OBJECTIVE
  For cardiac implantable electronic device (CIED) implantations, visualization of lead placement is necessary and fluoroscopy remains by far the most commonly used technique. With simple changes in the X-ray system settings, total radiation dose can be reduced significantly. The purpose of this study was to assess the safety and efficacy of various CIED implantations performed after implementation of a new dose reduction protocol (DRP).
  
  
  RESULTS
  We conducted a retrospective chart review of 584 patients undergoing CIED implantation or revision in our hospital. Of these patients, 280 (48%) underwent the implantation prior to and 304 (52%) after the DRP introduction. The DRP included various changes for optimized image processing and exposure system settings to enable dose reduction, as well as a reduced frame rates (4 FPS for fluoroscopy and 7.5 FPS for cinematographic images). Of the 584 patients, 53 (9.1%) had a one-chamber pacemaker, 232 (39.7%) a two-chamber pacemaker, 133 (22.8%) a one-chamber ICD, 35 (6.0%) a two-chamber ICD, 82 (14.0%) a CRT (de novo) implantation, and 49 (8.3%) had an upgrade to a CRT device. DRP was associated with a 64% reduction of the dose-area product (1372 ± 2659 vs. 3792 ± 5025 cGcm2, P < 0.001), while fluoroscopy duration (13 ± 15 vs. 13 ± 15 min) and procedural duration (93 ± 52 vs. 92 ± 52 min.) did not significantly increase. Complication rates did not differ significantly between the two groups.
  
  
  CONCLUSIONS
  The DRP proved to effectively reduce radiation dose for all types of CIED implantations. Fluoroscopy time, total procedure time, and the number of complications did not increase after introducing the DRP.
authors.affiliation: Department of Internal Medicine and Cardiology, Charité - Universitätsmedizin Berlin, Campus Virchow-Klinikum, Augustenburger Platz 1, Berlin 13353, Germany.
authors.forename: Philipp
authors.initials: P
authors.lastname: Attanasio
authors.affiliation: Department of Internal Medicine and Cardiology, Charité - Universitätsmedizin Berlin, Campus Virchow-Klinikum, Augustenburger Platz 1, Berlin 13353, Germany.
authors.forename: Melika
authors.initials: M
authors.lastname: Mirdamadi
authors.affiliation: Department of cardiac pacing and electrophysiology, CHU/Université de Bordeaux, Pessac, France.|L'Institut de Rythmologie et de Modélisation Cardiaque LIRYC, CHU/Université de Bordeaux/INSERM U1045, Pessac, France.
authors.forename: Jean-Yves
authors.initials: JY
authors.lastname: Wielandts
authors.affiliation: Department of Internal Medicine and Cardiology, Charité - Universitätsmedizin Berlin, Campus Virchow-Klinikum, Augustenburger Platz 1, Berlin 13353, Germany.|Department of Cardiology, German Heart Center Berlin, Berlin, Germany.
authors.forename: Burkert
authors.initials: B
authors.lastname: Pieske
authors.affiliation: Department of Internal Medicine and Cardiology, Charité - Universitätsmedizin Berlin, Campus Virchow-Klinikum, Augustenburger Platz 1, Berlin 13353, Germany.
authors.forename: Florian
authors.initials: F
authors.lastname: Blaschke
authors.affiliation: Department of Internal Medicine and Cardiology, Charité - Universitätsmedizin Berlin, Campus Virchow-Klinikum, Augustenburger Platz 1, Berlin 13353, Germany.
authors.forename: Leif-Hendrik
authors.initials: LH
authors.lastname: Boldt
authors.affiliation: Department of cardiac pacing and electrophysiology, CHU/Université de Bordeaux, Pessac, France.|L'Institut de Rythmologie et de Modélisation Cardiaque LIRYC, CHU/Université de Bordeaux/INSERM U1045, Pessac, France.
authors.forename: Pierre
authors.initials: P
authors.lastname: Jais
authors.affiliation: Department of Internal Medicine and Cardiology, Charité - Universitätsmedizin Berlin, Campus Virchow-Klinikum, Augustenburger Platz 1, Berlin 13353, Germany.
authors.forename: Wilhelm
authors.initials: W
authors.lastname: Haverkamp
authors.affiliation: Department of Internal Medicine and Cardiology, Charité - Universitätsmedizin Berlin, Campus Virchow-Klinikum, Augustenburger Platz 1, Berlin 13353, Germany.
authors.forename: Martin
authors.initials: M
authors.lastname: Huemer
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D058409:Cardiac Resynchronization Therapy Devices; D017147:Defibrillators, Implantable; D005260:Female; D005471:Fluoroscopy; D005858:Germany; D006801:Humans; D008297:Male; D008875:Middle Aged; D010138:Pacemaker, Artificial; D061214:Patient Safety; D015397:Program Evaluation; D011474:Prosthesis Design; D019919:Prosthesis Implantation / Q000009:adverse effects / Q000295:instrumentation* / Q000379:methods*; D065840:Protective Factors; D011829:Radiation Dosage; D000069079:Radiation Exposure / Q000009:adverse effects / Q000517:prevention & control*; D015641:Radiography, Interventional / Q000009:adverse effects; D012189:Retrospective Studies; D018570:Risk Assessment; D012307:Risk Factors; D055815:Young Adult
keywords: CIED implantations; Complications; Dose reduction; Fluoroscopy