Samir B Pancholy1, Pankaj Joshi2, Sanjay Shah3, Sunil V Rao4, Olivier F Bertrand5, Tejas M Patel6. 1. Wright Center for Graduate Medical Education, Commonwealth Medical College, Scranton, Pennsylvania. Electronic address: pancholys@gmail.com. 2. Seth N.H.L Municipal Medical College, Ahmedabad, India. 3. Department of Interventional Cardiology, Apex Heart Institute, Ahmedabad, India. 4. Duke Clinical Research Institute, Durham, North Carolina. 5. Quebec Heart and Lung Institute, Laval University, Quebec City, Quebec, Canada. 6. Apex Heart Institute, Ahmedabad, India.
Abstract
OBJECTIVES: This study sought to perform a randomized noninferiority trial of radiation exposure during cardiac catheterization comparing femoral access (FA) with left radial access (LRA) and right radial access (RRA). BACKGROUND: Increased radiation exposure with radial approach compared with femoral approach remains a controversial issue. METHODS: This study randomized 1,493 patients undergoing cardiac catheterization at a tertiary care center to FA, LRA, and RRA in a 1:1:1 fashion. The primary endpoint was air kerma. The secondary endpoints included dose-area product, fluoroscopy time and operator dose per procedure, number of cineangiograms, and number of catheters. RESULTS: Baseline and procedural characteristics were similar among groups. No significant differences were observed in air kerma (medians: FA: 421 mGy [interquartile range (IQR): 337 to 574 mGy], LRA: 454 mGy [IQR: 331 to 643 mGy], and RRA: 483 mGy [IQR: 382 to 592 mGy], p = 0.146), dose-area product (medians: FA: 25.5 Gy cm(2) [IQR: 19.6 to 34.5 Gy cm(2)], LRA: 26.6 Gy cm(2) [IQR: 19.5 to 37.5 Gy cm(2)], and RRA: 27.7 Gy cm(2) [IQR: 21.9 to 34.4 Gy cm(2)], p = 0.40), or fluoroscopy time (medians: FA: 1.3 min [IQR: 1.0 to 1.7 min], LRA: 1.3 min [IQR: 1.0 to 1.7 min], and RRA: 1.32 min [IQR: 1.0 to 1.7 min], p = 0.19) among the 3 access sites. Median operator exposure was higher in the LRA group (3 mrem [IQR: 2 to 5 mrem], p = 0.001 vs. FA, and p = 0.0001 vs. RRA) compared with the FA (2 mrem [IQR: 2 to 4 mrem] and RRA groups (3 mrem [IQR: 2 to 5 mrem]). CONCLUSIONS: Radiation exposure to patients was similar during diagnostic coronary angiography with FA, RRA, and LRA. However, LRA was associated with significantly higher operator radiation exposure than were FA and RRA procedures. (Randomized Evaluation of Vascular Entry Site and Radiation Exposure [REVERE]; NCT01677481).
RCT Entities:
OBJECTIVES: This study sought to perform a randomized noninferiority trial of radiation exposure during cardiac catheterization comparing femoral access (FA) with left radial access (LRA) and right radial access (RRA). BACKGROUND: Increased radiation exposure with radial approach compared with femoral approach remains a controversial issue. METHODS: This study randomized 1,493 patients undergoing cardiac catheterization at a tertiary care center to FA, LRA, and RRA in a 1:1:1 fashion. The primary endpoint was air kerma. The secondary endpoints included dose-area product, fluoroscopy time and operator dose per procedure, number of cineangiograms, and number of catheters. RESULTS: Baseline and procedural characteristics were similar among groups. No significant differences were observed in air kerma (medians: FA: 421 mGy [interquartile range (IQR): 337 to 574 mGy], LRA: 454 mGy [IQR: 331 to 643 mGy], and RRA: 483 mGy [IQR: 382 to 592 mGy], p = 0.146), dose-area product (medians: FA: 25.5 Gy cm(2) [IQR: 19.6 to 34.5 Gy cm(2)], LRA: 26.6 Gy cm(2) [IQR: 19.5 to 37.5 Gy cm(2)], and RRA: 27.7 Gy cm(2) [IQR: 21.9 to 34.4 Gy cm(2)], p = 0.40), or fluoroscopy time (medians: FA: 1.3 min [IQR: 1.0 to 1.7 min], LRA: 1.3 min [IQR: 1.0 to 1.7 min], and RRA: 1.32 min [IQR: 1.0 to 1.7 min], p = 0.19) among the 3 access sites. Median operator exposure was higher in the LRA group (3 mrem [IQR: 2 to 5 mrem], p = 0.001 vs. FA, and p = 0.0001 vs. RRA) compared with the FA (2 mrem [IQR: 2 to 4 mrem] and RRA groups (3 mrem [IQR: 2 to 5 mrem]). CONCLUSIONS: Radiation exposure to patients was similar during diagnostic coronary angiography with FA, RRA, and LRA. However, LRA was associated with significantly higher operator radiation exposure than were FA and RRA procedures. (Randomized Evaluation of Vascular Entry Site and Radiation Exposure [REVERE]; NCT01677481).
Authors: Binita Shah; Joseph Burdowski; Yu Guo; Bryan Velez de Villa; Andrew Huynh; Meena Farid; Mansi Maini; Claudia Serrano-Gomez; Cezar Staniloae; Frederick Feit; Michael J Attubato; James Slater; John Coppola Journal: Am J Cardiol Date: 2016-05-28 Impact factor: 2.778
Authors: Piotr Iwachow; Izabela Miechowicz; Piotr Kałmucki; Beata Dziki; Andrzej Szyszka; Artur Baszko; Tomasz Siminiak Journal: Int J Cardiovasc Imaging Date: 2017-03-31 Impact factor: 2.357