Back to Search
Start Over
Efficacy of the RADPAD Protection Drape in Reducing Operators' Radiation Exposure in the Catheterization Laboratory: A Sham-Controlled Randomized Trial.
- Source :
-
Circulation. Cardiovascular interventions [Circ Cardiovasc Interv] 2017 Nov; Vol. 10 (11). - Publication Year :
- 2017
-
Abstract
- Background: Interventional cardiologists are increasingly exposed to radiation-induced diseases like cataract and the stochastic risk of left-sided brain tumors. The RADPAD is a sterile, disposable, lead-free shield placed on the patient with the aim to minimize operator-received scatter radiation. The objective of the trial was to examine the RADPAD's efficacy in a real-world situation.<br />Methods and Results: In the current, double-blind, sham-controlled, all-comer trial, patients undergoing diagnostic catheterization or percutaneous coronary interventions were randomized in a 1:1:1 ratio to a radiation absorbing shield (RADPAD), standard treatment (NOPAD), or a sham shield (SHAMPAD). The sham shield allowed testing for shield-induced radiation behavior. The primary outcome was the difference in relative exposure of the primary operator between the RADPAD and NOPAD arms and was defined as the ratio between operator's exposure (E in µSv) and patient exposure (dose area product in mGy·cm <superscript>2</superscript> ), measured per procedure. A total of 766 consecutive coronary procedures were randomized to the use of RADPAD (N=255), NOPAD (N=255), or SHAMPAD (N=256). The use of RADPAD was associated with a 20% reduction in relative operator exposure compared with that of NOPAD ( P =0.01) and a 44% relative exposure reduction compared with the use of a SHAMPAD ( P <0.001). Use of the SHAMPAD was associated with a 43% higher relative radiation exposure than procedures with NOPAD ( P =0.009).<br />Conclusions: In clinical daily practice, the standard use of the RADPAD radiation shield reduced operator radiation exposure compared with procedures with NOPAD or SHAMPAD. This study supports the routine use of RADPAD in the catheterization laboratory.<br />Clinical Trial Registration: URL: https://www.clinicaltrials.gov. Unique identifier: NCT03139968.<br /> (© 2017 American Heart Association, Inc.)
- Subjects :
- Aged
Double-Blind Method
Female
Humans
Male
Middle Aged
Netherlands
Occupational Exposure adverse effects
Occupational Health
Prospective Studies
Protective Factors
Radiation Exposure adverse effects
Radiation Injuries etiology
Radiation Injuries prevention & control
Radiation Monitoring
Risk Assessment
Risk Factors
Cardiac Catheterization adverse effects
Cardiologists
Occupational Exposure prevention & control
Percutaneous Coronary Intervention adverse effects
Radiation Dosage
Radiation Exposure prevention & control
Radiation Protection instrumentation
Radiography, Interventional adverse effects
Radiologists
Surgical Drapes
Subjects
Details
- Language :
- English
- ISSN :
- 1941-7632
- Volume :
- 10
- Issue :
- 11
- Database :
- MEDLINE
- Journal :
- Circulation. Cardiovascular interventions
- Publication Type :
- Academic Journal
- Accession number :
- 29089313
- Full Text :
- https://doi.org/10.1161/CIRCINTERVENTIONS.117.006058