Determinants of operator and patient radiation exposure during cardiac catheterization: Insights from the RadiCure (RADIation reduction during cardiac catheterization using real-timE monitoring) trial.

BACKGROUND: In the RadiCure study 505 catheterization procedures were 1:1 randomized to use or no use of real-time radiation monitoring. Use of the Bleeper Sv monitor resulted in a significant reduction in operator radiation exposure. METHODS: We examined the association between several baseline and procedural parameters with operator and patient radiation exposure using univariable and multivariable analysis in the 505 patients that were enrolled in RadiCure. All baseline demographic and procedure characteristics recorded were included in the univariable analysis. RESULTS: Median fluoroscopy time was 6.2 (2.5-12.5) minutes, median patient air kerma dose was 0.908 (0.602-1.636) Gray and median first operator exposure was 10 (5-22) µSv. For analysis purposes, the 505 procedures were dichotomized based on the median operator exposure (10 µSv) and median patient radiation dose (0.908 Gray). On multivariable analysis, factors associated with high (above median or >10 µSv) first operator radiation exposure included radial access (odds ratio [OR] 5.44, 95% Confidence Interval [CI] 2.88-10.76), chronic total occlusion (CTO) intervention (OR 12.78, 95% CI 4.42-43.60), real-time radiation monitoring (OR 0.42, 95% CI 0.26-0.66), and use of a radioabsorbent drape (OR 0.53, 95% CI 0.28-0.96). High patient radiation dose (above median or >0.908 Gray) was associated with body mass index>30 kg/m2 (OR 3.22, 95% CI 1.99-5.29), prior MI (OR 2.26, 95% CI 1.29-4.04), prior cerebrovascular disease (OR 0.34, 95% CI 0.15-0.75), hypertension (OR 2.40, 95% CI 1.05-5.82), prior coronary artery bypass graft surgery (OR 2.46, 95% CI 1.40-4.39) and CTO intervention (OR 12.93, 95% CI 3.28-87.31), but was not associated with real-time radiation monitoring and use of a radioabsorbent drape. CONCLUSIONS: Several clinical and procedural factors are associated with higher patient and operator radiation exposure. Real-time radiation monitoring and use of disposable radiation shields were associated with lower operator, but not patient, radiation dose. © 2015 Wiley Periodicals, Inc.

Impact of a Disposable Sterile Radiation Shield on Operator Radiation Exposure During Percutaneous Coronary Intervention of Chronic Total Occlusions.

BACKGROUND: Daily radiation exposure over many years can adversely impact the health of medical professionals. METHODS: Operator radiation exposure was recorded for 124 percutaneous coronary interventions (PCIs) performed at our institution between August 2011 and May 2013: 69 were chronic total occlusion (CTO)-PCIs and 55 were non-CTO PCIs. A disposable radiation protection sterile drape (Radpad; Worldwide Innovations & Technologies, Inc) was used in all CTO-PCI cases vs none of the non-CTO PCI cases. Operator radiation exposure was compared between CTO and non-CTO PCIs. RESULTS: Mean age was 64.6 ± 6.2 years and 99.2% of the patients were men. Compared with non-CTO PCI, patients undergoing CTO-PCI were more likely to have congestive heart failure, to be current smokers, and to have longer lesions, and less likely to have prior PCI and a saphenous vein graft target lesion. CTO-PCI cases had longer procedural time (median: 123 minutes [IQR, 85-192 minutes] vs 27 minutes [IQR, 20-44 minutes]; P<.001), fluoroscopy time (35 minutes [IQR, 19-54 minutes] vs 8 minutes [IQR, 5-16 minutes]; P<.001), number of stents placed (2.4 ± 1.5 vs 1.7 ± 0.9; P<.001), and patient air kerma radiation exposure (3.92 Gray [IQR, 2.48-5.86 Gray] vs 1.22 Gray [IQR, 0.74-1.90 Gray]; P<.001), as well as dose area product (267 Gray•cm² [IQR, 163-4.25 Gray•cm²] vs 84 Gray•cm² [IQR, 48-138 Gray•cm²]; P<.001). In spite of higher patient radiation exposure, operator radiation exposure was similar between the two groups (20 µSv [IQR, 9.5-31 µSv] vs 15 µSv [IQR, 7-23 µSv]; P=.07). CONCLUSIONS: Operator radiation exposure during CTO-PCI can be reduced to levels similar to less complicated cases with the use of a disposable sterile radiation protection shield.

Systematic Review of the BridgePoint System for Crossing Coronary and Peripheral Chronic Total Occlusions.

BACKGROUND: The BridgePoint system consists of the CrossBoss coronary catheter and Stingray CTO system (Boston Scientific) for coronary chronic total occlusions (CTOs), and the Viance crossing catheter and Enteer re-entry system (Covidien) for peripheral CTOs. METHODS: We performed a systematic review of the literature on the BridgePoint system published between October 2008 and August 2014, in accordance with the standards set forth in the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement. RESULTS: We identified a total of 20 studies: 12 studies on coronary CTOs (10 retrospective with 2 prospective case series) and 8 studies on peripheral CTOs (all retrospective). Among 320 patients undergoing coronary CTO intervention, pooled technical success and major adverse cardiac event rates were 77.1% and 3.8%, respectively. Among 175 patients undergoing peripheral CTO intervention, pooled technical success and major adverse events were 82.2% and 4.6%, respectively. Only 1 study reported long-term outcomes after use of the coronary BridgePoint system, demonstrating similar incidence of major adverse cardiac events between BridgePoint-treated and non-BridgePoint treated patients; however, the study had low power. CONCLUSIONS: The BridgePoint system is associated with high procedural success rates and low complication rates when used for crossing both coronary and peripheral CTOs.

Effect of a real-time radiation monitoring device on operator radiation exposure during cardiac catheterization: the radiation reduction during cardiac catheterization using real-time monitoring study.

BACKGROUND: The Radiation Reduction During Cardiac Catheterization Using Real-Time Monitoring study sought to examine the effect of a radiation detection device that provides real-time operator dose reporting through auditory feedback (Bleeper Sv; Vertec Scientific Ltd; Berkshire, UK) on patient dose and operator exposure during cardiac catheterization. METHODS AND RESULTS: Between January 2012 and May 2014, 505 patients undergoing coronary angiography, percutaneous coronary intervention, or both were randomized to use (n=253) or no use (n=252) of the Bleeper Sv radiation monitor. Operator radiation exposure was measured in both groups using a second, silent radiation exposure monitoring device. Mean patient age was 65±8 years, most patients (99%) were men, and 30% had prior coronary artery bypass graft surgery. Baseline clinical characteristics were similar in the 2 study groups. Radial access was used in 18% and chronic total occlusion percutaneous coronary intervention constituted 7% of the total procedures. Median procedure time was 17 (12-27) minutes for diagnostic angiography, 42 (28-70) minutes for percutaneous coronary intervention, and 27 (14-51) minutes in the overall study population, with similar distribution between the study groups. First (9 [4-17] versus 14 [7-25] µSv; P<0.001) and second (5 [2-10] versus 7 [4-14] µSv; P<0.001) operator radiation exposure was significantly lower in the Bleeper Sv group. Use of the device did not result in a significant reduction in patient radiation dose. The effect of the Bleeper Sv device on operator radiation exposure was consistent among various study subgroups. CONCLUSIONS: Use of a real-time radiation monitoring device that provides auditory feedback can significantly reduce operator radiation exposure during cardiac catheterization. CLINICAL TRIAL REGISTRATION URL: http://www.clinicaltrials.gov. Unique identifier: NCT01510353.

Frequency and outcomes of aortocoronary dissection during percutaneous coronary intervention of chronic total occlusions: a case series and systematic review of the literature.

BACKGROUND: Aortocoronary dissection can complicate percutaneous coronary intervention (PCI) of chronic total occlusions (CTOs). METHODS: We retrospectively examined the frequency and outcomes of aortocoronary dissection among 336 consecutive CTO PCIs performed at our institution between 2005 and 2012 and performed a systematic review of the published literature. RESULTS: Aortocoronary dissection occurred in six patients (1.8%, 95% confidence intervals 0.7%, 3.8%). All aortocoronary dissections occurred in the right coronary artery (CTO target vessel in five patients and donor vessel in one patient). The baseline clinical characteristics of patients with and without aortocoronary dissection were similar. Compared to patients without, those with aortocoronary dissection were more likely to undergo crossing attempts using the retrograde approach (25% vs. 67%, P = 0.036) and experience a major complication (2.4% vs. 33.3%, P = 0.008). Technical and procedural success rates were similar in both groups. Of the six patients with aortocoronary dissection one underwent emergency coronary bypass graft surgery (CABG), four were treated with ostial stenting, and one was treated conservatively without subsequent adverse clinical outcomes. Systematic literature review provided 107 published cases of aortocoronary dissection during PCI, that occurred mainly in the right coronary artery (74.8%) and were treated with stenting (49.5%), emergency CABG (29%), or conservatively (21.5%). CONCLUSIONS: Aortocoronary dissection is an infrequent complication of CTO PCI and although it can be treated with stents in most patients, it may infrequently require emergency CABG.

Angiographic success and procedural complications in patients undergoing percutaneous coronary chronic total occlusion interventions: a weighted meta-analysis of 18,061 patients from 65 studies.

OBJECTIVES: This study sought to perform a weighted meta-analysis of the complication risk during chronic total occlusion (CTO) percutaneous coronary intervention (PCI). BACKGROUND: The safety profile of CTO PCI has received limited study. METHODS: We conducted a meta-analysis of 65 studies published between 2000 and 2011 reporting procedural complications of CTO PCI. Data on the frequency of death, emergent coronary artery bypass graft surgery, stroke, myocardial infarction, perforation, tamponade, stent thrombosis, major vascular or bleeding events, contrast nephropathy, and radiation skin injury were collected. RESULTS: A total of 65 studies with 18,061 patients and 18,941 target CTO vessels were included. Pooled estimates of outcomes were as follows: angiographic success 77% (95% confidence interval [CI]: 74.3% to 79.6%); death 0.2% (95% CI: 0.1% to 0.3%); emergent coronary artery bypass graft surgery 0.1% (95% CI: 0.0% to 0.2%); stroke <0.01% (95% CI: 0.0% to 0.1%); myocardial infarction 2.5% (95% CI: 1.9% to 3.0%); Q-wave myocardial infarction 0.2% (95% CI: 0.1% to 0.3%); coronary perforation 2.9% (95% CI: 2.2% to 3.6%); tamponade 0.3% (95% CI: 0.2% to 0.5%); and contrast nephropathy 3.8% (95% CI: 2.4% to 5.3%). Compared with successful procedures, unsuccessful procedures had higher rates of death (0.42% vs. 1.54%, p < 0.0001), perforation (3.65% vs. 10.70%, p < 0.0001), and tamponade (0% vs. 1.65%, p < 0.0001). Among 886 lesions treated with the retrograde approach, success rate was 79.8% with no deaths and low rates of emergent coronary artery bypass graft surgery (0.17%) and tamponade (1.2%). CONCLUSIONS: CTO PCI carries low risk for procedural complications despite high success rates.