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Use of prospective radiobrachial angiography in transradial cardiac catheterization and intervention
CARREV-01719; No of Pages 7 Cardiovascular Revascularization Medicine xxx (xxxx) xxx
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Cardiovascular Revascularization Medicine
Use of prospective radiobrachial angiography in transradial cardiac catheterization and intervention Joseph A. Kern a, Frank A. Medina a, Linda Lee b, Kiran Kaur b, Sandeep Nathan b, John E.A. Blair b,⁎ a b
University of Chicago Pritzker School of Medicine, The University of Chicago Medicine Heart & Vascular Center, Chicago, IL, United States of America University of Chicago Medical Center: Section of Cardiology — Department of Medicine, The University of Chicago Medicine Heart & Vascular Center, Chicago, IL, United States of America
a r t i c l e
i n f o
Article history: Received 13 April 2019 Received in revised form 17 September 2019 Accepted 2 October 2019 Available online xxxx Keywords: PCI Radial angiography Transradial approach
a b s t r a c t Objectives: This study examined the utility of prospective radiobrachial angiography (pRBA) in transradial coronary angiography and intervention as a method for reducing procedural complications. Background: A growing body of evidence has supported the transradial approach (TRA) as superior to the transfemoral approach (TFA) due to advantages such as reduced bleeding and improved outcomes in high-risk patients. However, TRA has a higher failure rate than TFA, and has seen slow rates of adoption among United States operators. Methods: This was a retrospective, single center, case-control analysis of coronary angiography procedures, performed by two experienced operators at the University of Chicago Medical Center between October 28, 2015 and July 21, 2017. Operator 1 began using pRBA during the study, whereas Operator 2 used pRBA in all TRA procedures. There were 567 patients stratified into three groups based on operator and pRBA use. Comparisons of procedural outcomes for Operator 1 before and after adoption of pRBA, and of outcomes between Operator 1 and Operator 2 were made. Results: Use of pRBA was associated with reduced overall procedural complication rates (2.5% versus 10.4%, p = 0.004), driven primarily by reflexive radiobrachial angiography (rRBA) after resistance or pain was encountered (8.6% versus 0.0%, p = 0.0001) for Operator 1. A slight reduction in contrast associated with pRBA for Operator 1 was noted, but no difference in procedural time, radiation dose, or additional equipment used across groups was found. No significant difference in adverse procedural outcomes between the pRBA groups of Operator 1 and Operator 2 were observed. In patients with radiobrachial variants in anatomy, use of pRBA was associated with shorter times to cross anatomic lesions, shorter procedure times, reduced use of extra catheters, and less perforations and crossovers compared to patients requiring rRBA. Lack of pRBA was associated with higher procedural complications (hazard ratio 1.08, 95% CI, 1.03–1.13, p = 0.004). Conclusion: pRBA may be a useful tool for mitigating procedural complications, reducing time needed to cross difficult radiobrachial anatomy, and reducing the need to utilize additional equipment in TRA. pRBA may offer operators a tool to improve outcomes and increase adoption of this approach. © 2019 Elsevier Inc. All rights reserved.
1. Introduction Given that over a million cardiac catheterizations were performed in the United States in 2010 alone, it is essential to ensure safe and effective procedural techniques that maximize benefits for patients and minimize risk [1]. Over the nearly three decades following the introduction of the radial artery as an alternative access site for coronary angiography and intervention, a growing body of evidence has supported the transradial approach (TRA) as superior to the transfemoral approach ⁎ Corresponding author at: Section of Cardiology, Department of Medicine, University of Chicago Medical Center, MC5076, 5841 South Maryland Avenue, Chicago, IL 60637, United States of America. E-mail address: [email protected] (J.E.A. Blair).
(TFA). This superiority is due to advantages such as reduced access site bleeding and vascular complications [2–6], a mortality benefit for patients presenting with ST-elevated myocardial infarction (STEMI) [7,8], reduced major adverse cardiac events (MACE) [9], shortened hospital stays [2,10], increased patient comfort [11,12], and minimized cost [11,13,14]. Despite a class I indication for TRA in both European Society of Cardiology 2015 guidelines for Acute Coronary Syndromes [15] and 2018 guidelines for Myocardial Revascularization [16], operators in the United States are slow to adopt this practice, with only 25.3% of PCIs being performed transradially in 2014 [17]. This slow adoption of TRA may in part be due to higher rates of procedural failure in TRA when compared to TFA: approximately 5% in TRA versus 2% in TFA, especially during PCIs [18,19]. In a large analysis of over 2000 patients
https://doi.org/10.1016/j.carrev.2019.10.005 1553-8389/© 2019 Elsevier Inc. All rights reserved.
Please cite this article as: J.A. Kern, F.A. Medina, L. Lee, et al., Use of prospective radiobrachial angiography in transradial cardiac catheterization and intervention, Cardiovascular Revascularization Medicine, https://doi.org/10.1016/j.carrev.2019.10.005
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J.A. Kern et al. / Cardiovascular Revascularization Medicine xxx (xxxx) xxx
undergoing TRA, approximately 51% of failed PCIs were due to radial artery factors such as radial loops, spasm, stenosis or dissection, contributing to the 4–12% access site crossover to the femoral artery [20,21]. A method to potentially mitigate risk and reduce procedural failure in patients undergoing TRA is the implementation of prospective radiobrachial angiography (pRBA) prior to coronary angiography to allow operators to visualize and plan for difficult to navigate radial anatomy [20–22]. The present study sought to further explore the benefits of pRBA in patients undergoing TRA in a diverse urban population. This case-control series examined 567 transradial cardiac catheterization patients and compared procedural outcomes in a single high-volume operator before and after adoption of pRBA, and compared outcomes between two high-volume operators utilizing pRBA. 2. Methods This was a retrospective, single-center, observational case-control analysis of transradial cardiac catheterization procedures conducted at the University of Chicago Medical Center between October 28, 2015 and July 21, 2017. All study subjects underwent TRA in a single highvolume center by one of two interventional cardiologists with N4 years of prior experience with TRA for coronary angiography, and N100 PCIs using TRA performed annually. Patients undergoing TRA cardiac catheterization or intervention were considered for the analysis. Vulnerable populations, such as incarcerated individuals, hospital staff, and students were excluded. The institution's institutional review board approved the study protocol. To allow for both internal, or intra-operator, and external, interoperator, control groups, patients were stratified into three groups, by operator and by use of pRBA. Operator 1 did not implement pRBA until midway through the study period, but universally performed pRBA after adoption of the technique. Operator 2 had implemented universal pRBA years prior to the study period. Radial anatomy and procedural outcomes before and after Operator 1's adoption of pRBA were compared, as were the outcomes of Operator 1 and Operator 2. 2.1. Data collection Baseline demographic, vitals, medical, clinical, medication, procedural, and discharge data were obtained through chart review of the electronic medical record of study subjects (Epic 2015, Epic Systems Corporation). Radiobrachial angiograms were assessed retrospectively by two investigators (JAK, FAM). 2.2. Radial angiography and coronary angiography Radial artery cannulation was performed using standard techniques [23]. Following insertion of a transradial sheath and spasmolytic cocktail, a digital subtraction angiogram was performed in the contralateral angulation of 10–20°. Coronary angiography and intervention was performed using standard procedures explained in the 2013 ACCF/SCAI Expert Consensus Document of Cardiac Catheterization Laboratory Standards Update [24]. The spasmolytic/anticoagulant cocktail used consisted of 70 U/kg Heparin, 200 μg Nitroglycerin, and 2.5 mg Verapamil if heart rate was above 60 bpm. 2.3. Endpoints The primary endpoint of the study was a combined endpoint of successful procedural completion without perforation, crossover to alternative access site, or resistance or pain leading to reflexive radiobrachial angiography (rRBA). Individual components of the primary endpoint were also analyzed. Secondary outcomes were overall procedural length, contrast use, diagnostic and guide catheter use, guide wire use, post-procedure complications, and complication rates among the radial artery anomalies.
2.4. Statistical analysis Kruskal Wallis equality of populations rank test was used to compare the distribution of patients across the groups of Operators 1 and 2, t-test determined differences in groups by outcome, and linear regression, using baseline clinical characteristics, was used to predict procedural complication. In analysis of the effect of anomalous radiobrachial Table 1 Baseline clinical information. Operator 1
Operator 2
p Value
Group 1
Group 2
Group 3
non-pRBA
pRBA
pRBA
(n = 163)
(n = 161)
(n = 243)
63.6 ± 12.6
64.9 ± 11.7
79 (49.1%) 82 (50.9%)
160 (65.8%) 83 (34.2%)
11 (6.8%) 147 (91.3%)
17 (7%) 225 (92.6%)
94 (58.4%) 56 (34.8%) 3 (1.9%) 8 (5%)
114 (46.9%) 115 (47.3%) 8 (3.3%) 6 (2.5%)
0.02 b0.001 0.6 0.07
30.2 ± 7.8 129.4 ± 21.9 71.9 ± 11.4 92 ± 14.2
31.2 ± 16.2 130.5 ± 24.8 69.7 ± 13.1 92 ± 16
0.97 0.5 0.2 0.4
28 (17.4%) 11 (6.8%) 75 (46.6%) 2 (1.2%) 134 (83.2%) 18 (11.2%) 30 (18.6%) 12 (7.5%) 20 (12.4%) 54 (33.5%)
48 (19.8%) 39 (16%) 110 (45.3%) 4 (1.6%) 215 (88.5%) 43 (17.7%) 35 (14.4%) 10 (4.1%) 29 (11.9%) 98 (40.3%)
0.02 b0.001 0.6 0.02 0.03 0.001 0.4 0.3 0.9 0.3
90 (55.9%) 25 (15.5%) 35 (21.7%)
148 (60.9%) 40 (16.5%) 79 (32.5%)
0.4 0.06 0.04
3 (1.9%) 31 (19.3%) 36 (22.4%) 33 (20.5%) 47 (29.2%) 11 (6.8%)
11 (4.5%) 43 (17.7%) 86 (35.4%) 37 (15.2%) 49 (20.2%) 17 (7%)
0.2 0.8 b0.001 0.1 0.06 0.7
0 45 (28%) 112 (69.6%) 4 (2.5%)
6 (2.5%) 28 (11.5%) 202 (83.1%) 7 (2.9%)
0.02 b0.001 b0.001 0.3
0 138 (85.7%) 11 (6.8%)
17 (7%) 158 (65%) 36 (14.8%)
b0.001 b0.001 0.02
12 (7.5%) 53 (32.9%) 6 (3.7%) 3 (1.9%)
26 (10.7%) 74 (30.5%) 16 (6.6%) 0
0.3 0.06 0.01 0.02
Demographics Age (yrs) 62 ± 12.3 Sex Male 84 (51.5%) Female 79 (48.5%) Ethnicity Hispanic 17 (10.4%) Non-Hispanic 142 (87.1%) Race African American 97 (59.5%) Caucasian 48 (29.4%) Asian 6 (3.7%) Other 12 (7.4%) Vitals BMI (kg/m2) 30.3 ± 8.1 SBP (mm Hg) 127.7 ± 26.7 DBP (mm Hg) 70.4 ± 13.3 MAP (mm Hg) 90.8 ± 18.1 Comorbidities MI 15 (9.2%) CABG 9 (5.5%) CHF 82 (50.3%) Heart transplant 9 (5.5%) HTN 128 (78.5%) PAD 9 (5.5%) COPD 23 (14.1%) ESRD 8 (4.9%) CVD 18 (11%) DM 67 (41.1%) Tobacco Ever smoker 90 (55.2%) Current smoker 30 (18.4%) PCI performed 44 (30%) Indication for procedure STEMI 10 (6.1%) NSTEMI/UAP 27 (16.6%) Stable angina 27 (16.6%) Preoperative 37 (22.7%) CHF 47 (28.8%) Other 15 (9.2%) Sheath size 4Fr 0 5Fr 22 (13.5%) 6Fr 140 (85.9%) 7Fr 1 (0.6%) Largest diagnostic catheter 4Fr 0 5Fr 122 (74.8%) 6Fr 29 (17.8%) Largest guide catheter 5Fr 11 (6.7%) 6Fr 69 (42.3%) 7Fr 1 (0.6%) 7.5Fr 0
0.03 0.001
0.2
Values are mean ± SD or n (%). Abbreviations: BMI, body mass index; SBP, systolic blood pressure; DBP, diastolic blood pressure; MAP, mean arterial pressure; MI, myocardial infarction; CABG, coronary artery bypass graft; CHF, congestive heart failure; HTN, hypertension; PAD, peripheral artery disease; COPD, chronic obstructive pulmonary disease; ESRD, end stage renal disease; CVD, cerebrovascular disease; DM, diabetes mellitus; PCI, percutaneous coronary intervention; STEMI, ST-elevation myocardial infarction; NSTEMI, nonST-elevation myocardial infarction; UAP, unstable angina pectoris; Fr, French.
Please cite this article as: J.A. Kern, F.A. Medina, L. Lee, et al., Use of prospective radiobrachial angiography in transradial cardiac catheterization and intervention, Cardiovascular Revascularization Medicine, https://doi.org/10.1016/j.carrev.2019.10.005
J.A. Kern et al. / Cardiovascular Revascularization Medicine xxx (xxxx) xxx Table 2. Procedural outcomes of Operator 1 without and with pRBA. Operator 1
Primary access location Right radial Left radial Success rate Mean contrast (mL) Mean cumulative DAP (Gy cm2) Any procedural complication Perforation Crossover Resistance/pain met requiring rRBA Crossover Right femoral Right radial Post-procedure complicationsa Hematoma Major bleed MI Vascular complication Radial artery occlusion
p-Value
Group 1
Group 2
non-pRBA
pRBA
(n = 163)
(n = 161)
137 (84%) 26 (16%) 158 (96.9%) 118.3 ± 78.3 75.0 ± 69.5 17 (10.4%) 3 5 14 5 (3.1%) 4 1
136 (84.4%) 25 (15.5%) 158 (98.1%) 100.7 ± 58.5 68.7 ± 71.6% 4 (2.5%) 0 4 0 4 (2.5%) 4 0
0.9 0.9 0.5 0.02 0.4 0.004 0.08 0.8 b0.001 0.8 0.99 0.3
2 1 1 0 0
0 0 0 0 0
0.2 0.3 0.3 NA NA
Values are n (%). Abbreviation: DAP, dose area product. a Monitored until discharge.
anatomy on procedural time or time to cross anatomic lesions, comparisons between pRBA and rRBA groups were made with one-way analysis of variance. Chi-squared analysis was used to determine associations between anomalous radiobrachial anatomy and procedural complications between pRBA and rRBA groups. Statistical analysis was performed using Stata 15 (StataCorp, College Station, Texas). 3. Results 3.1. Clinical characteristics A total of 567 patients were stratified based on the operator and if pRBA was used: Groups 1 and 2 were patients under Operator 1 (Group 1 (Controls), n = 163, pRBA not used; Group 2 (Cases), n
3
= 161, pRBA used); Group 3 were patients under Operator 2 (Group 3 (Cases), n = 243, pRBA used). Baseline clinical characteristics are summarized in Table 1. The mean age was 63.7 ± 12.2 years, and there were more male and African American patients represented across the population. There were significant differences in age, sex, race, components of the comorbidity profile, indication, and sheath/catheter size. 3.2. Transradial cardiac catheterization and intervention procedural outcomes among Operator 1 When comparing Operator 1 before versus after adoption of pRBA, use of the right radial artery as the primary access location was similar (84.0% versus 84.5%, p = 0.9), and TRA success rate was similarly high (96.9% versus 98.1%, p = 0.5) (Table 2, Fig. 1). There was a small reduction in mean contrast volume used (118.3 ± 78.3 versus 100.7 ± 58.5 mL, p = 0.02), possibly due to fewer PCIs (26.9% versus 21.7%, p = 0.04), but no difference in procedural time, radiation dose, or additional equipment before and after adoption of pRBA. Crossover rates were not statistically different in Operator 1 before adoption of pRBA (Crossover: 3.1% versus 2.5%, p = 0.8). There was a higher rate of procedural complications in Operator 1 before adoption of pRBA (10.4% versus 2.5%, p = 0.004) driven by a higher rate of pain or resistance requiring rRBA (14 versus 0, p b 0.001) (Table 2). Post-procedural complications were low and not different between groups. Examples of findings following rRBA are depicted in Fig. 2. 3.3. Procedural outcomes between Operator 1 and Operator 2 When comparing the pRBA groups of Operator 1 versus Operator 2, use of the right radial artery as the primary access location was significantly higher (84.4% versus 37.4%, p b 0.001), however success rates were similarly high (98.1% versus 95.9%, p = 0.2) (Table 3). Operator 1 used less mean cumulative contrast when compared to Operator 2 (100.7 ± 58.5 mL versus 117.5 ± 65.3 mL, p = 0.008), likely due to the higher number of PCIs performed by Operator 2 for pRBA groups (21.7% versus 32.5%, p = 0.019). For PCIs, Operator 1 had longer procedural time than Operator 2 (104.9 ± 45.8 versus 88.8 ± 33.1 min, p = 0.04), however the opposite was true for diagnostic procedures (49.4
20 17 **
Frequency, n
15
14
**
10
5 5
4
4
3 ** P<0.01
0
0
0 Perforation
Crossover Group 1 (non-pRBA)
Reflexive Radiobrachial Angiography
Any Complicaon
Group 2 (pRBA)
Fig. 1. Comparison of operator 1 procedural complications before and after implementation of pRBA. Use of pRBA in Operator 1 was associated with a reduction in rates of any complication and the need for rRBA. pRBA = prospective radiobrachial angiography; rRBA = retrospective radiobrachial angiography.
Please cite this article as: J.A. Kern, F.A. Medina, L. Lee, et al., Use of prospective radiobrachial angiography in transradial cardiac catheterization and intervention, Cardiovascular Revascularization Medicine, https://doi.org/10.1016/j.carrev.2019.10.005
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J.A. Kern et al. / Cardiovascular Revascularization Medicine xxx (xxxx) xxx
Fig. 2. Examples of radial artery variation found after reflexive radiobrachial angiography. 1a and 1b, tortuous radial artery anatomy; 2, a focal radial artery spasm; 3a and 3b, diffuse radial artery spasm; 4, a tortuous vessel with focal vasospasm; 5a and 5b, radial loop; 6, radial artery dissection with contrast extravasation.
± 25.0 versus 56.3 ± 24.9 min, p = 0.02). For diagnostic procedures, Operator 1 used less diagnostic catheters and guidewires than Operator 2. Otherwise, there were no significant differences between the pRBA groups of Operators 1 and 2 with regard to procedural complications, Table 3 Procedural outcomes of Operator 1 versus Operator 2 with pRBA.
Primary access location Right radial Left radial Success rate Mean contrast (mL) Mean cumulative DAP (Gy cm2) Any procedural complication Perforation Crossover Resistance/pain met requiring rRBA Crossover Right femoral Right radial Left radial Post-procedure complicationsa Hematoma Major bleed MI Vascular complication Radial artery occlusion
Operator 1
Operator 2
Group 2
Group 3
pRBA
pRBA
(n = 161)
(n = 243)
p-Value Table 4 Reasons for procedural complications. Operator 1
136 (84.4%) 25 (15.5%) 158 (97%) 100.7 ± 58.5 68.7 ± 71.6 4 (2.5%) 0 4 0 4 (2.5%) 4 0 0
91 (37.4%) 152 (62.5%) 233 (96.0%) 117.5 ± 65.3 76.1 ± 66.6 12 (4.9%) 1 11 0 11 (4.5%) 10 0 1
b0.001 b0.001 0.2 0.008 0.3 0.2 0.4 0.3 NA 0.3 0.4 NA 0.4
0 0 0 0 0
0 0 0 1 0
NA NA NA 0.4 NA
Values are n (%). Abbreviation: DAP, dose area product. a Monitored until discharge.
catheter failure, or crossover. Post-procedure complications were low and not different between groups. Reasons for radial access failure varied between operators and use of pRBA, while reasons for rRBA were driven primarily by resistance or pain and upon imaging, findings included radial loop (35.7), perforation (21.4%), spasm (21.4%), and tortuosity (14.2%) (Table 4).
Perforation Crossover Radial loop Radial spasm Subclavian tortuosity Subclavian stenosis Brachiocephalic tortuosity Engagement Reflexive radiobrachial angiography Pain Resistance Findings Loop Perforation Spasm Tortuosity Other
Operator 2
Group 1
Group 2
Group 3
non-pRBA
pRBA
pRBA
(n = 163)
(n = 161)
(n = 243)
3 (1.8%) 5 (3.1%) 2 0 0 0 1 2 14 (8.5%) 3 13
0 4 (2.5%) 0 2 2 0 0 0 0
1 (0.4%) 11 (4.5%) 1 1 5 1 0 3 0
5 3 3 2 2
Values are n (%).
Please cite this article as: J.A. Kern, F.A. Medina, L. Lee, et al., Use of prospective radiobrachial angiography in transradial cardiac catheterization and intervention, Cardiovascular Revascularization Medicine, https://doi.org/10.1016/j.carrev.2019.10.005
J.A. Kern et al. / Cardiovascular Revascularization Medicine xxx (xxxx) xxx
3.4. Predictors of procedural complications
Table 6 Procedural outcomes and radiobrachial variants in anatomy.
A univariate regression analysis highlighted no pRBA use (Hazard Ratio 1.09, 95% CI 1.03–1.16, p = 0.002) as well as male gender, height, PCI performed, and Hispanic ethnicity as independent variables for predicting procedural complications (Table 5). Of note, neither sheath nor catheter size were predictors of procedural complications in the univariate analysis. 3.5. Effect of radiobrachial variants in anatomy on procedural outcomes Student's t-test, revealed significant reductions in both total procedure time (57.8 ± 31.5 vs 117.4 ± 80.7, p b 0.001) and time needed to cross anatomic lesions (4.9 ± 5.3 vs 12.5 ± 9.1, p b 0.001) in comparison of pRBA and rRBA groups. The differences in total procedural length were seen primarily in diagnostic catheterizations (41.0 ± 17.5 vs 65.2 ± 20.6, p = 0.007). Chi-square analysis of various procedural outcomes and the role of anatomy revealed significant differences between rRBA and pRBA groups with anomalous radial anatomy. A greater percentage of procedures requiring rRBA also required an operator to change practice (85.7% vs 44%, p = 0.01) driven primarily by the use of extra catheters (50% vs 9.4%, p = 0.006) to cross anatomic lesions. pRBA was associated with lower rates of perforation (0 vs 3, p = 0.007) and crossover (0 vs 2, p = 0.03), when compared to rRBA. No significant differences in rates of patient pain/discomfort were noted between groups (Table 6). 4. Discussion Despite the many benefits of TRA when compared to TFA, adoption is slow in the United States. Whether related to a steeper operator learning curve [25] or lack of efficient and effective tools to improve outcomes, it is imperative to explore and evaluate techniques that will reduce barriers to TRA adoption. The present study offers one such technique that can be adopted by any operator and help to improve standard of care and practice. We have demonstrated that routine use of prospective radiobrachial angiography in transradial access is associated with lower complication rates, similar procedure times and equipment use compared to standard angiography. Furthermore, we have demonstrated that pRBA offers significant advantages when spasm or anomalous radiobrachial anatomy is encountered. We demonstrate that use of pRBA significantly reduced the rates of procedural complications, primarily driven by decreased radial artery perforation and reduced need for rRBA. Although use of pRBA did not appear to reduced rates of crossover to TFA or improve procedural success, it also did not add significant time or contrast use to the overall procedure. When spasm or anomalous radiobrachial anatomy was encountered, pRBA offered many advantages including reductions in overall procedure time, time needed to cross lesions, operator change in practice and procedural complications. A recent study comparing 762 ST-segment elevation myocardial infarction (STEMI) patients undergoing primary PCI using TRA with pRBA to 5068 similar patients prior to adoption of pRBA [26] demonstrated lower rates of complications among the pRBA group. Similar to our study and others [27], there were overall high rates of procedural success and low rates of access site complications; and pRBA was associated
Table 5 Univariate predictors of procedural complications.
Operator 1 no pRBA Hispanic PCI performed Height Male sex
5
Hazard ratio (95% CI)
p-Value
1.08 (1.03–1.13) 1.13 (1.03–1.22) 1.07 (1.03–1.11) 0.997 (0.995–0.998) 0.958 (0.919–0.997)
0.004 0.01 0.002 b0.001 0.036
Time crossing (min) Avg total procedure time (min) Diagnostic (n) Intervention (n) Change in practice, n (%)a Extra wire Extra catheter Patient discomfort, n (%) Perforation, n (%) Crossover, n (%)
pRBA (n = 32)
rRBA (n = 14)
p-Value
4.9 ± 5.3 57.8 ± 31.5 41.0 ± 17.5 (23) 100.7 ± 11.1 (9) 14 (44%) 14 3 3 (9.4%) 0 0
12.5 ± 9.1 117.4 ± 80.7 65.2 ± 20.6 (6) 156.5 ± 87.8 (8) 12 (85.7%) 10 7 3 (21.4%) 3 (21.4%) 2 (14.3%)
b0.001 b0.001 0.007 0.08 0.01 0.2 0.006 0.07 0.007 0.03
Radiobrachial variants include: vasospasm = 22 (47.8%), tortuosity = 5 (10.9%) anomalous RA origin = 8 (17.4%), loop = 11 (23.9%), atresia = 0 (0). a Change in practice = use of anything other than standard catheters and a J-wire. Extra wires include Wholey, glide, glide advantage, prowater, run through, etc. Extra catheters include anything other than the planned catheters for a standard diagnostic or interventional procedure.
with a lower complication rate compared to non-pRBA procedures. Although this study, by Zafirovska et al., demonstrated a higher pRBA success rate (95% versus 97%, p b 0.001), it is unclear whether temporal improvements in equipment and technique explain this difference. Importantly, although the STEMI study demonstrated significantly longer procedure times after adoption of pRBA, we found no such difference between groups, and showed no significant differences in radiation dose or equipment use. It is likely that although pRBA may add additional time at the beginning of the procedure, it allows adequate visualization of the radial artery course and presence of spasm or anatomical variations that are navigated with ease once the operator is aware of this anatomy. This advantage is demonstrated in Table 6, where pRBA is associated with less time needed to cross anatomic lesions, fewer extra catheters used, and shorter overall diagnostic procedure times. In addition to a time advantage, pRBA was associated with reductions in perforation, crossover, access failure and catheter failure. Taken together these data suggest that pRBA allows for more efficiency in the face of spasm or complicated radial anatomy. It is important to note that in the majority of cases in which rRBA was performed, there was either pain or patient discomfort, resistance to passage of equipment, or both. When rRBA was performed, anatomical or functional variation was encountered; such variations as radial loops, tortuosity, or spasm were commonly found and although these abnormalities were navigated successfully once found, these procedures were longer and more complicated when compared to pRBA cases with anomalous radiobrachial artery anatomy. Despite these significant findings, a confounding variable to TRA failure rates that must not be ignored is operator experience. With the upsurge in adoption of TRA, the learning curve requires 200 TRA diagnostic cardiac catheterization and 30–50 PCI cases to achieve the proficiency and safety of an operator with N300 case experience [28–30]. It has also been found that experience of the operator impacts outcomes beyond the learning curve, as explained by a 5 year prospective institutional study of over 10,000 TRA procedures revealing that crossover rates decrease over time among standard and dedicated radial interventionalists [19]. Implementing pRBA into common TRA procedural technique may aid in expediting this reduction in crossover rates. A univariate regression analysis revealed a negative correlation between use of pRBA and procedural complications under Operator 1. As reported here, the reduction in transradial procedural complications seen after adoption of pRBA may suggest an alternative for low-volume and novice radial operators — reducing the time to proficiency and failure or complication rates. Large national studies done in the United Kingdom by the British Cardiovascular Intervention Society have shown that the superiority of TRA is best demonstrated among highvolume operators, as they are more able to improve their proficiency through repeated practice in high-risk patients [31]. When accounting
Please cite this article as: J.A. Kern, F.A. Medina, L. Lee, et al., Use of prospective radiobrachial angiography in transradial cardiac catheterization and intervention, Cardiovascular Revascularization Medicine, https://doi.org/10.1016/j.carrev.2019.10.005
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J.A. Kern et al. / Cardiovascular Revascularization Medicine xxx (xxxx) xxx
for confounding variables, low-volume centers are not an independent predictor for complications, but operator experience is [19,31]. Failure rate and the learning curve associated with TRA could be addressed by the implementation of pRBA in all TRA cardiac catheterization and intervention. A further reduction in TRA complications may encourage more U.S. operators to utilize the radial approach, further benefiting higherrisk patients and shifting the gold standard from TFA. However, prospective randomized trials are required to further elucidate these findings and to address the limitations of this study. 4.1. Limitations While this study offers some insight into one method for improved outcomes in TRA, there were limitations. In examining the relationship between pre- and post-adoption of pRBA and rates of complications, only a single operator was examined, limiting the ability to generalize this study. Further, given practice and expected improvement over time, improved outcomes with implementation of pRBA may be an effect of operator experience, given Operator 1's five years interventional experience, rather than a product of pRBA utility or a product of both. A larger, randomized prospective study that involves many operators would be necessary to better elucidate the benefit of pRBA. Additionally, there were significant differences between groups in rates of hypertension, coronary artery disease, myocardial infarction, coronary bypass grafts, race, and sheath/catheter size, which may have influenced procedural outcomes. The present study also demonstrated an association between female gender and increased procedural complication rates. Studies out of our group have demonstrated smaller radial artery caliber among female patients [32], which may have contributed to this association and presents as a possible confounder that would need to be addressed in future studies. It is also important to note that no preprocedural radial artery testing, such as Allen/Barbeau testing or ultrasound, was performed in the present study. Recent studies have demonstrated no difference in functional hand outcomes in patients lacking dual circulation to the hand [33,34], resulting in contemporary registry observations that only 37% of operators test for dual circulation [35] and an American Heart Association consensus statement for acute coronary syndromes not recommending such routine screening [36]. Nonetheless, the utility of these tests or ultrasound screening may be an important avenue of exploration in future studies. Additionally, radial artery occlusion is an important, albeit rare, complication of TRA which can complicate future procedures and has the potential to affect upper extremity function. Emerging research, however, demonstrates that while upper extremity function may be impacted in the short-term, it is not in the long-term [33]. RA occlusion was not systematically assessed prospectively in the current study and would need to be addressed in future study of TRA. Lastly, many operators may be reluctant to use pRBA due to the potential pain associated with the use of contrast dye. While this is not something that has been studied to date, it would be an essential addition to any future randomized prospective trials. 5. Conclusions By providing an optimized view of the radial artery prior to the start of procedure, pRBA allows an operator to detect potential complications early and establish strategies for traversing difficult anatomy. pRBA offers a practical method for reducing in-procedure complications during transradial cardiac catheterization and intervention. When difficult radial artery anatomy is encountered, pRBA offers reduced overall procedure time and time needed to cross anatomic lesions as well as reductions in complications and extra catheter utilization. Taken together, pRBA may help reduce barriers to the adoption of TRA in the United States, and improve outcomes during and following cardiac catheterization and intervention.
Supplementary data to this article can be found online at https://doi. org/10.1016/j.carrev.2019.10.005.
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Please cite this article as: J.A. Kern, F.A. Medina, L. Lee, et al., Use of prospective radiobrachial angiography in transradial cardiac catheterization and intervention, Cardiovascular Revascularization Medicine, https://doi.org/10.1016/j.carrev.2019.10.005
Contents lists available at ScienceDirect
Cardiovascular Revascularization Medicine
Use of prospective radiobrachial angiography in transradial cardiac catheterization and intervention Joseph A. Kern a, Frank A. Medina a, Linda Lee b, Kiran Kaur b, Sandeep Nathan b, John E.A. Blair b,⁎ a b
University of Chicago Pritzker School of Medicine, The University of Chicago Medicine Heart & Vascular Center, Chicago, IL, United States of America University of Chicago Medical Center: Section of Cardiology — Department of Medicine, The University of Chicago Medicine Heart & Vascular Center, Chicago, IL, United States of America
a r t i c l e
i n f o
Article history: Received 13 April 2019 Received in revised form 17 September 2019 Accepted 2 October 2019 Available online xxxx Keywords: PCI Radial angiography Transradial approach
a b s t r a c t Objectives: This study examined the utility of prospective radiobrachial angiography (pRBA) in transradial coronary angiography and intervention as a method for reducing procedural complications. Background: A growing body of evidence has supported the transradial approach (TRA) as superior to the transfemoral approach (TFA) due to advantages such as reduced bleeding and improved outcomes in high-risk patients. However, TRA has a higher failure rate than TFA, and has seen slow rates of adoption among United States operators. Methods: This was a retrospective, single center, case-control analysis of coronary angiography procedures, performed by two experienced operators at the University of Chicago Medical Center between October 28, 2015 and July 21, 2017. Operator 1 began using pRBA during the study, whereas Operator 2 used pRBA in all TRA procedures. There were 567 patients stratified into three groups based on operator and pRBA use. Comparisons of procedural outcomes for Operator 1 before and after adoption of pRBA, and of outcomes between Operator 1 and Operator 2 were made. Results: Use of pRBA was associated with reduced overall procedural complication rates (2.5% versus 10.4%, p = 0.004), driven primarily by reflexive radiobrachial angiography (rRBA) after resistance or pain was encountered (8.6% versus 0.0%, p = 0.0001) for Operator 1. A slight reduction in contrast associated with pRBA for Operator 1 was noted, but no difference in procedural time, radiation dose, or additional equipment used across groups was found. No significant difference in adverse procedural outcomes between the pRBA groups of Operator 1 and Operator 2 were observed. In patients with radiobrachial variants in anatomy, use of pRBA was associated with shorter times to cross anatomic lesions, shorter procedure times, reduced use of extra catheters, and less perforations and crossovers compared to patients requiring rRBA. Lack of pRBA was associated with higher procedural complications (hazard ratio 1.08, 95% CI, 1.03–1.13, p = 0.004). Conclusion: pRBA may be a useful tool for mitigating procedural complications, reducing time needed to cross difficult radiobrachial anatomy, and reducing the need to utilize additional equipment in TRA. pRBA may offer operators a tool to improve outcomes and increase adoption of this approach. © 2019 Elsevier Inc. All rights reserved.
1. Introduction Given that over a million cardiac catheterizations were performed in the United States in 2010 alone, it is essential to ensure safe and effective procedural techniques that maximize benefits for patients and minimize risk [1]. Over the nearly three decades following the introduction of the radial artery as an alternative access site for coronary angiography and intervention, a growing body of evidence has supported the transradial approach (TRA) as superior to the transfemoral approach ⁎ Corresponding author at: Section of Cardiology, Department of Medicine, University of Chicago Medical Center, MC5076, 5841 South Maryland Avenue, Chicago, IL 60637, United States of America. E-mail address: [email protected] (J.E.A. Blair).
(TFA). This superiority is due to advantages such as reduced access site bleeding and vascular complications [2–6], a mortality benefit for patients presenting with ST-elevated myocardial infarction (STEMI) [7,8], reduced major adverse cardiac events (MACE) [9], shortened hospital stays [2,10], increased patient comfort [11,12], and minimized cost [11,13,14]. Despite a class I indication for TRA in both European Society of Cardiology 2015 guidelines for Acute Coronary Syndromes [15] and 2018 guidelines for Myocardial Revascularization [16], operators in the United States are slow to adopt this practice, with only 25.3% of PCIs being performed transradially in 2014 [17]. This slow adoption of TRA may in part be due to higher rates of procedural failure in TRA when compared to TFA: approximately 5% in TRA versus 2% in TFA, especially during PCIs [18,19]. In a large analysis of over 2000 patients
https://doi.org/10.1016/j.carrev.2019.10.005 1553-8389/© 2019 Elsevier Inc. All rights reserved.
Please cite this article as: J.A. Kern, F.A. Medina, L. Lee, et al., Use of prospective radiobrachial angiography in transradial cardiac catheterization and intervention, Cardiovascular Revascularization Medicine, https://doi.org/10.1016/j.carrev.2019.10.005
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J.A. Kern et al. / Cardiovascular Revascularization Medicine xxx (xxxx) xxx
undergoing TRA, approximately 51% of failed PCIs were due to radial artery factors such as radial loops, spasm, stenosis or dissection, contributing to the 4–12% access site crossover to the femoral artery [20,21]. A method to potentially mitigate risk and reduce procedural failure in patients undergoing TRA is the implementation of prospective radiobrachial angiography (pRBA) prior to coronary angiography to allow operators to visualize and plan for difficult to navigate radial anatomy [20–22]. The present study sought to further explore the benefits of pRBA in patients undergoing TRA in a diverse urban population. This case-control series examined 567 transradial cardiac catheterization patients and compared procedural outcomes in a single high-volume operator before and after adoption of pRBA, and compared outcomes between two high-volume operators utilizing pRBA. 2. Methods This was a retrospective, single-center, observational case-control analysis of transradial cardiac catheterization procedures conducted at the University of Chicago Medical Center between October 28, 2015 and July 21, 2017. All study subjects underwent TRA in a single highvolume center by one of two interventional cardiologists with N4 years of prior experience with TRA for coronary angiography, and N100 PCIs using TRA performed annually. Patients undergoing TRA cardiac catheterization or intervention were considered for the analysis. Vulnerable populations, such as incarcerated individuals, hospital staff, and students were excluded. The institution's institutional review board approved the study protocol. To allow for both internal, or intra-operator, and external, interoperator, control groups, patients were stratified into three groups, by operator and by use of pRBA. Operator 1 did not implement pRBA until midway through the study period, but universally performed pRBA after adoption of the technique. Operator 2 had implemented universal pRBA years prior to the study period. Radial anatomy and procedural outcomes before and after Operator 1's adoption of pRBA were compared, as were the outcomes of Operator 1 and Operator 2. 2.1. Data collection Baseline demographic, vitals, medical, clinical, medication, procedural, and discharge data were obtained through chart review of the electronic medical record of study subjects (Epic 2015, Epic Systems Corporation). Radiobrachial angiograms were assessed retrospectively by two investigators (JAK, FAM). 2.2. Radial angiography and coronary angiography Radial artery cannulation was performed using standard techniques [23]. Following insertion of a transradial sheath and spasmolytic cocktail, a digital subtraction angiogram was performed in the contralateral angulation of 10–20°. Coronary angiography and intervention was performed using standard procedures explained in the 2013 ACCF/SCAI Expert Consensus Document of Cardiac Catheterization Laboratory Standards Update [24]. The spasmolytic/anticoagulant cocktail used consisted of 70 U/kg Heparin, 200 μg Nitroglycerin, and 2.5 mg Verapamil if heart rate was above 60 bpm. 2.3. Endpoints The primary endpoint of the study was a combined endpoint of successful procedural completion without perforation, crossover to alternative access site, or resistance or pain leading to reflexive radiobrachial angiography (rRBA). Individual components of the primary endpoint were also analyzed. Secondary outcomes were overall procedural length, contrast use, diagnostic and guide catheter use, guide wire use, post-procedure complications, and complication rates among the radial artery anomalies.
2.4. Statistical analysis Kruskal Wallis equality of populations rank test was used to compare the distribution of patients across the groups of Operators 1 and 2, t-test determined differences in groups by outcome, and linear regression, using baseline clinical characteristics, was used to predict procedural complication. In analysis of the effect of anomalous radiobrachial Table 1 Baseline clinical information. Operator 1
Operator 2
p Value
Group 1
Group 2
Group 3
non-pRBA
pRBA
pRBA
(n = 163)
(n = 161)
(n = 243)
63.6 ± 12.6
64.9 ± 11.7
79 (49.1%) 82 (50.9%)
160 (65.8%) 83 (34.2%)
11 (6.8%) 147 (91.3%)
17 (7%) 225 (92.6%)
94 (58.4%) 56 (34.8%) 3 (1.9%) 8 (5%)
114 (46.9%) 115 (47.3%) 8 (3.3%) 6 (2.5%)
0.02 b0.001 0.6 0.07
30.2 ± 7.8 129.4 ± 21.9 71.9 ± 11.4 92 ± 14.2
31.2 ± 16.2 130.5 ± 24.8 69.7 ± 13.1 92 ± 16
0.97 0.5 0.2 0.4
28 (17.4%) 11 (6.8%) 75 (46.6%) 2 (1.2%) 134 (83.2%) 18 (11.2%) 30 (18.6%) 12 (7.5%) 20 (12.4%) 54 (33.5%)
48 (19.8%) 39 (16%) 110 (45.3%) 4 (1.6%) 215 (88.5%) 43 (17.7%) 35 (14.4%) 10 (4.1%) 29 (11.9%) 98 (40.3%)
0.02 b0.001 0.6 0.02 0.03 0.001 0.4 0.3 0.9 0.3
90 (55.9%) 25 (15.5%) 35 (21.7%)
148 (60.9%) 40 (16.5%) 79 (32.5%)
0.4 0.06 0.04
3 (1.9%) 31 (19.3%) 36 (22.4%) 33 (20.5%) 47 (29.2%) 11 (6.8%)
11 (4.5%) 43 (17.7%) 86 (35.4%) 37 (15.2%) 49 (20.2%) 17 (7%)
0.2 0.8 b0.001 0.1 0.06 0.7
0 45 (28%) 112 (69.6%) 4 (2.5%)
6 (2.5%) 28 (11.5%) 202 (83.1%) 7 (2.9%)
0.02 b0.001 b0.001 0.3
0 138 (85.7%) 11 (6.8%)
17 (7%) 158 (65%) 36 (14.8%)
b0.001 b0.001 0.02
12 (7.5%) 53 (32.9%) 6 (3.7%) 3 (1.9%)
26 (10.7%) 74 (30.5%) 16 (6.6%) 0
0.3 0.06 0.01 0.02
Demographics Age (yrs) 62 ± 12.3 Sex Male 84 (51.5%) Female 79 (48.5%) Ethnicity Hispanic 17 (10.4%) Non-Hispanic 142 (87.1%) Race African American 97 (59.5%) Caucasian 48 (29.4%) Asian 6 (3.7%) Other 12 (7.4%) Vitals BMI (kg/m2) 30.3 ± 8.1 SBP (mm Hg) 127.7 ± 26.7 DBP (mm Hg) 70.4 ± 13.3 MAP (mm Hg) 90.8 ± 18.1 Comorbidities MI 15 (9.2%) CABG 9 (5.5%) CHF 82 (50.3%) Heart transplant 9 (5.5%) HTN 128 (78.5%) PAD 9 (5.5%) COPD 23 (14.1%) ESRD 8 (4.9%) CVD 18 (11%) DM 67 (41.1%) Tobacco Ever smoker 90 (55.2%) Current smoker 30 (18.4%) PCI performed 44 (30%) Indication for procedure STEMI 10 (6.1%) NSTEMI/UAP 27 (16.6%) Stable angina 27 (16.6%) Preoperative 37 (22.7%) CHF 47 (28.8%) Other 15 (9.2%) Sheath size 4Fr 0 5Fr 22 (13.5%) 6Fr 140 (85.9%) 7Fr 1 (0.6%) Largest diagnostic catheter 4Fr 0 5Fr 122 (74.8%) 6Fr 29 (17.8%) Largest guide catheter 5Fr 11 (6.7%) 6Fr 69 (42.3%) 7Fr 1 (0.6%) 7.5Fr 0
0.03 0.001
0.2
Values are mean ± SD or n (%). Abbreviations: BMI, body mass index; SBP, systolic blood pressure; DBP, diastolic blood pressure; MAP, mean arterial pressure; MI, myocardial infarction; CABG, coronary artery bypass graft; CHF, congestive heart failure; HTN, hypertension; PAD, peripheral artery disease; COPD, chronic obstructive pulmonary disease; ESRD, end stage renal disease; CVD, cerebrovascular disease; DM, diabetes mellitus; PCI, percutaneous coronary intervention; STEMI, ST-elevation myocardial infarction; NSTEMI, nonST-elevation myocardial infarction; UAP, unstable angina pectoris; Fr, French.
Please cite this article as: J.A. Kern, F.A. Medina, L. Lee, et al., Use of prospective radiobrachial angiography in transradial cardiac catheterization and intervention, Cardiovascular Revascularization Medicine, https://doi.org/10.1016/j.carrev.2019.10.005
J.A. Kern et al. / Cardiovascular Revascularization Medicine xxx (xxxx) xxx Table 2. Procedural outcomes of Operator 1 without and with pRBA. Operator 1
Primary access location Right radial Left radial Success rate Mean contrast (mL) Mean cumulative DAP (Gy cm2) Any procedural complication Perforation Crossover Resistance/pain met requiring rRBA Crossover Right femoral Right radial Post-procedure complicationsa Hematoma Major bleed MI Vascular complication Radial artery occlusion
p-Value
Group 1
Group 2
non-pRBA
pRBA
(n = 163)
(n = 161)
137 (84%) 26 (16%) 158 (96.9%) 118.3 ± 78.3 75.0 ± 69.5 17 (10.4%) 3 5 14 5 (3.1%) 4 1
136 (84.4%) 25 (15.5%) 158 (98.1%) 100.7 ± 58.5 68.7 ± 71.6% 4 (2.5%) 0 4 0 4 (2.5%) 4 0
0.9 0.9 0.5 0.02 0.4 0.004 0.08 0.8 b0.001 0.8 0.99 0.3
2 1 1 0 0
0 0 0 0 0
0.2 0.3 0.3 NA NA
Values are n (%). Abbreviation: DAP, dose area product. a Monitored until discharge.
anatomy on procedural time or time to cross anatomic lesions, comparisons between pRBA and rRBA groups were made with one-way analysis of variance. Chi-squared analysis was used to determine associations between anomalous radiobrachial anatomy and procedural complications between pRBA and rRBA groups. Statistical analysis was performed using Stata 15 (StataCorp, College Station, Texas). 3. Results 3.1. Clinical characteristics A total of 567 patients were stratified based on the operator and if pRBA was used: Groups 1 and 2 were patients under Operator 1 (Group 1 (Controls), n = 163, pRBA not used; Group 2 (Cases), n
3
= 161, pRBA used); Group 3 were patients under Operator 2 (Group 3 (Cases), n = 243, pRBA used). Baseline clinical characteristics are summarized in Table 1. The mean age was 63.7 ± 12.2 years, and there were more male and African American patients represented across the population. There were significant differences in age, sex, race, components of the comorbidity profile, indication, and sheath/catheter size. 3.2. Transradial cardiac catheterization and intervention procedural outcomes among Operator 1 When comparing Operator 1 before versus after adoption of pRBA, use of the right radial artery as the primary access location was similar (84.0% versus 84.5%, p = 0.9), and TRA success rate was similarly high (96.9% versus 98.1%, p = 0.5) (Table 2, Fig. 1). There was a small reduction in mean contrast volume used (118.3 ± 78.3 versus 100.7 ± 58.5 mL, p = 0.02), possibly due to fewer PCIs (26.9% versus 21.7%, p = 0.04), but no difference in procedural time, radiation dose, or additional equipment before and after adoption of pRBA. Crossover rates were not statistically different in Operator 1 before adoption of pRBA (Crossover: 3.1% versus 2.5%, p = 0.8). There was a higher rate of procedural complications in Operator 1 before adoption of pRBA (10.4% versus 2.5%, p = 0.004) driven by a higher rate of pain or resistance requiring rRBA (14 versus 0, p b 0.001) (Table 2). Post-procedural complications were low and not different between groups. Examples of findings following rRBA are depicted in Fig. 2. 3.3. Procedural outcomes between Operator 1 and Operator 2 When comparing the pRBA groups of Operator 1 versus Operator 2, use of the right radial artery as the primary access location was significantly higher (84.4% versus 37.4%, p b 0.001), however success rates were similarly high (98.1% versus 95.9%, p = 0.2) (Table 3). Operator 1 used less mean cumulative contrast when compared to Operator 2 (100.7 ± 58.5 mL versus 117.5 ± 65.3 mL, p = 0.008), likely due to the higher number of PCIs performed by Operator 2 for pRBA groups (21.7% versus 32.5%, p = 0.019). For PCIs, Operator 1 had longer procedural time than Operator 2 (104.9 ± 45.8 versus 88.8 ± 33.1 min, p = 0.04), however the opposite was true for diagnostic procedures (49.4
20 17 **
Frequency, n
15
14
**
10
5 5
4
4
3 ** P<0.01
0
0
0 Perforation
Crossover Group 1 (non-pRBA)
Reflexive Radiobrachial Angiography
Any Complicaon
Group 2 (pRBA)
Fig. 1. Comparison of operator 1 procedural complications before and after implementation of pRBA. Use of pRBA in Operator 1 was associated with a reduction in rates of any complication and the need for rRBA. pRBA = prospective radiobrachial angiography; rRBA = retrospective radiobrachial angiography.
Please cite this article as: J.A. Kern, F.A. Medina, L. Lee, et al., Use of prospective radiobrachial angiography in transradial cardiac catheterization and intervention, Cardiovascular Revascularization Medicine, https://doi.org/10.1016/j.carrev.2019.10.005
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J.A. Kern et al. / Cardiovascular Revascularization Medicine xxx (xxxx) xxx
Fig. 2. Examples of radial artery variation found after reflexive radiobrachial angiography. 1a and 1b, tortuous radial artery anatomy; 2, a focal radial artery spasm; 3a and 3b, diffuse radial artery spasm; 4, a tortuous vessel with focal vasospasm; 5a and 5b, radial loop; 6, radial artery dissection with contrast extravasation.
± 25.0 versus 56.3 ± 24.9 min, p = 0.02). For diagnostic procedures, Operator 1 used less diagnostic catheters and guidewires than Operator 2. Otherwise, there were no significant differences between the pRBA groups of Operators 1 and 2 with regard to procedural complications, Table 3 Procedural outcomes of Operator 1 versus Operator 2 with pRBA.
Primary access location Right radial Left radial Success rate Mean contrast (mL) Mean cumulative DAP (Gy cm2) Any procedural complication Perforation Crossover Resistance/pain met requiring rRBA Crossover Right femoral Right radial Left radial Post-procedure complicationsa Hematoma Major bleed MI Vascular complication Radial artery occlusion
Operator 1
Operator 2
Group 2
Group 3
pRBA
pRBA
(n = 161)
(n = 243)
p-Value Table 4 Reasons for procedural complications. Operator 1
136 (84.4%) 25 (15.5%) 158 (97%) 100.7 ± 58.5 68.7 ± 71.6 4 (2.5%) 0 4 0 4 (2.5%) 4 0 0
91 (37.4%) 152 (62.5%) 233 (96.0%) 117.5 ± 65.3 76.1 ± 66.6 12 (4.9%) 1 11 0 11 (4.5%) 10 0 1
b0.001 b0.001 0.2 0.008 0.3 0.2 0.4 0.3 NA 0.3 0.4 NA 0.4
0 0 0 0 0
0 0 0 1 0
NA NA NA 0.4 NA
Values are n (%). Abbreviation: DAP, dose area product. a Monitored until discharge.
catheter failure, or crossover. Post-procedure complications were low and not different between groups. Reasons for radial access failure varied between operators and use of pRBA, while reasons for rRBA were driven primarily by resistance or pain and upon imaging, findings included radial loop (35.7), perforation (21.4%), spasm (21.4%), and tortuosity (14.2%) (Table 4).
Perforation Crossover Radial loop Radial spasm Subclavian tortuosity Subclavian stenosis Brachiocephalic tortuosity Engagement Reflexive radiobrachial angiography Pain Resistance Findings Loop Perforation Spasm Tortuosity Other
Operator 2
Group 1
Group 2
Group 3
non-pRBA
pRBA
pRBA
(n = 163)
(n = 161)
(n = 243)
3 (1.8%) 5 (3.1%) 2 0 0 0 1 2 14 (8.5%) 3 13
0 4 (2.5%) 0 2 2 0 0 0 0
1 (0.4%) 11 (4.5%) 1 1 5 1 0 3 0
5 3 3 2 2
Values are n (%).
Please cite this article as: J.A. Kern, F.A. Medina, L. Lee, et al., Use of prospective radiobrachial angiography in transradial cardiac catheterization and intervention, Cardiovascular Revascularization Medicine, https://doi.org/10.1016/j.carrev.2019.10.005
J.A. Kern et al. / Cardiovascular Revascularization Medicine xxx (xxxx) xxx
3.4. Predictors of procedural complications
Table 6 Procedural outcomes and radiobrachial variants in anatomy.
A univariate regression analysis highlighted no pRBA use (Hazard Ratio 1.09, 95% CI 1.03–1.16, p = 0.002) as well as male gender, height, PCI performed, and Hispanic ethnicity as independent variables for predicting procedural complications (Table 5). Of note, neither sheath nor catheter size were predictors of procedural complications in the univariate analysis. 3.5. Effect of radiobrachial variants in anatomy on procedural outcomes Student's t-test, revealed significant reductions in both total procedure time (57.8 ± 31.5 vs 117.4 ± 80.7, p b 0.001) and time needed to cross anatomic lesions (4.9 ± 5.3 vs 12.5 ± 9.1, p b 0.001) in comparison of pRBA and rRBA groups. The differences in total procedural length were seen primarily in diagnostic catheterizations (41.0 ± 17.5 vs 65.2 ± 20.6, p = 0.007). Chi-square analysis of various procedural outcomes and the role of anatomy revealed significant differences between rRBA and pRBA groups with anomalous radial anatomy. A greater percentage of procedures requiring rRBA also required an operator to change practice (85.7% vs 44%, p = 0.01) driven primarily by the use of extra catheters (50% vs 9.4%, p = 0.006) to cross anatomic lesions. pRBA was associated with lower rates of perforation (0 vs 3, p = 0.007) and crossover (0 vs 2, p = 0.03), when compared to rRBA. No significant differences in rates of patient pain/discomfort were noted between groups (Table 6). 4. Discussion Despite the many benefits of TRA when compared to TFA, adoption is slow in the United States. Whether related to a steeper operator learning curve [25] or lack of efficient and effective tools to improve outcomes, it is imperative to explore and evaluate techniques that will reduce barriers to TRA adoption. The present study offers one such technique that can be adopted by any operator and help to improve standard of care and practice. We have demonstrated that routine use of prospective radiobrachial angiography in transradial access is associated with lower complication rates, similar procedure times and equipment use compared to standard angiography. Furthermore, we have demonstrated that pRBA offers significant advantages when spasm or anomalous radiobrachial anatomy is encountered. We demonstrate that use of pRBA significantly reduced the rates of procedural complications, primarily driven by decreased radial artery perforation and reduced need for rRBA. Although use of pRBA did not appear to reduced rates of crossover to TFA or improve procedural success, it also did not add significant time or contrast use to the overall procedure. When spasm or anomalous radiobrachial anatomy was encountered, pRBA offered many advantages including reductions in overall procedure time, time needed to cross lesions, operator change in practice and procedural complications. A recent study comparing 762 ST-segment elevation myocardial infarction (STEMI) patients undergoing primary PCI using TRA with pRBA to 5068 similar patients prior to adoption of pRBA [26] demonstrated lower rates of complications among the pRBA group. Similar to our study and others [27], there were overall high rates of procedural success and low rates of access site complications; and pRBA was associated
Table 5 Univariate predictors of procedural complications.
Operator 1 no pRBA Hispanic PCI performed Height Male sex
5
Hazard ratio (95% CI)
p-Value
1.08 (1.03–1.13) 1.13 (1.03–1.22) 1.07 (1.03–1.11) 0.997 (0.995–0.998) 0.958 (0.919–0.997)
0.004 0.01 0.002 b0.001 0.036
Time crossing (min) Avg total procedure time (min) Diagnostic (n) Intervention (n) Change in practice, n (%)a Extra wire Extra catheter Patient discomfort, n (%) Perforation, n (%) Crossover, n (%)
pRBA (n = 32)
rRBA (n = 14)
p-Value
4.9 ± 5.3 57.8 ± 31.5 41.0 ± 17.5 (23) 100.7 ± 11.1 (9) 14 (44%) 14 3 3 (9.4%) 0 0
12.5 ± 9.1 117.4 ± 80.7 65.2 ± 20.6 (6) 156.5 ± 87.8 (8) 12 (85.7%) 10 7 3 (21.4%) 3 (21.4%) 2 (14.3%)
b0.001 b0.001 0.007 0.08 0.01 0.2 0.006 0.07 0.007 0.03
Radiobrachial variants include: vasospasm = 22 (47.8%), tortuosity = 5 (10.9%) anomalous RA origin = 8 (17.4%), loop = 11 (23.9%), atresia = 0 (0). a Change in practice = use of anything other than standard catheters and a J-wire. Extra wires include Wholey, glide, glide advantage, prowater, run through, etc. Extra catheters include anything other than the planned catheters for a standard diagnostic or interventional procedure.
with a lower complication rate compared to non-pRBA procedures. Although this study, by Zafirovska et al., demonstrated a higher pRBA success rate (95% versus 97%, p b 0.001), it is unclear whether temporal improvements in equipment and technique explain this difference. Importantly, although the STEMI study demonstrated significantly longer procedure times after adoption of pRBA, we found no such difference between groups, and showed no significant differences in radiation dose or equipment use. It is likely that although pRBA may add additional time at the beginning of the procedure, it allows adequate visualization of the radial artery course and presence of spasm or anatomical variations that are navigated with ease once the operator is aware of this anatomy. This advantage is demonstrated in Table 6, where pRBA is associated with less time needed to cross anatomic lesions, fewer extra catheters used, and shorter overall diagnostic procedure times. In addition to a time advantage, pRBA was associated with reductions in perforation, crossover, access failure and catheter failure. Taken together these data suggest that pRBA allows for more efficiency in the face of spasm or complicated radial anatomy. It is important to note that in the majority of cases in which rRBA was performed, there was either pain or patient discomfort, resistance to passage of equipment, or both. When rRBA was performed, anatomical or functional variation was encountered; such variations as radial loops, tortuosity, or spasm were commonly found and although these abnormalities were navigated successfully once found, these procedures were longer and more complicated when compared to pRBA cases with anomalous radiobrachial artery anatomy. Despite these significant findings, a confounding variable to TRA failure rates that must not be ignored is operator experience. With the upsurge in adoption of TRA, the learning curve requires 200 TRA diagnostic cardiac catheterization and 30–50 PCI cases to achieve the proficiency and safety of an operator with N300 case experience [28–30]. It has also been found that experience of the operator impacts outcomes beyond the learning curve, as explained by a 5 year prospective institutional study of over 10,000 TRA procedures revealing that crossover rates decrease over time among standard and dedicated radial interventionalists [19]. Implementing pRBA into common TRA procedural technique may aid in expediting this reduction in crossover rates. A univariate regression analysis revealed a negative correlation between use of pRBA and procedural complications under Operator 1. As reported here, the reduction in transradial procedural complications seen after adoption of pRBA may suggest an alternative for low-volume and novice radial operators — reducing the time to proficiency and failure or complication rates. Large national studies done in the United Kingdom by the British Cardiovascular Intervention Society have shown that the superiority of TRA is best demonstrated among highvolume operators, as they are more able to improve their proficiency through repeated practice in high-risk patients [31]. When accounting
Please cite this article as: J.A. Kern, F.A. Medina, L. Lee, et al., Use of prospective radiobrachial angiography in transradial cardiac catheterization and intervention, Cardiovascular Revascularization Medicine, https://doi.org/10.1016/j.carrev.2019.10.005
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J.A. Kern et al. / Cardiovascular Revascularization Medicine xxx (xxxx) xxx
for confounding variables, low-volume centers are not an independent predictor for complications, but operator experience is [19,31]. Failure rate and the learning curve associated with TRA could be addressed by the implementation of pRBA in all TRA cardiac catheterization and intervention. A further reduction in TRA complications may encourage more U.S. operators to utilize the radial approach, further benefiting higherrisk patients and shifting the gold standard from TFA. However, prospective randomized trials are required to further elucidate these findings and to address the limitations of this study. 4.1. Limitations While this study offers some insight into one method for improved outcomes in TRA, there were limitations. In examining the relationship between pre- and post-adoption of pRBA and rates of complications, only a single operator was examined, limiting the ability to generalize this study. Further, given practice and expected improvement over time, improved outcomes with implementation of pRBA may be an effect of operator experience, given Operator 1's five years interventional experience, rather than a product of pRBA utility or a product of both. A larger, randomized prospective study that involves many operators would be necessary to better elucidate the benefit of pRBA. Additionally, there were significant differences between groups in rates of hypertension, coronary artery disease, myocardial infarction, coronary bypass grafts, race, and sheath/catheter size, which may have influenced procedural outcomes. The present study also demonstrated an association between female gender and increased procedural complication rates. Studies out of our group have demonstrated smaller radial artery caliber among female patients [32], which may have contributed to this association and presents as a possible confounder that would need to be addressed in future studies. It is also important to note that no preprocedural radial artery testing, such as Allen/Barbeau testing or ultrasound, was performed in the present study. Recent studies have demonstrated no difference in functional hand outcomes in patients lacking dual circulation to the hand [33,34], resulting in contemporary registry observations that only 37% of operators test for dual circulation [35] and an American Heart Association consensus statement for acute coronary syndromes not recommending such routine screening [36]. Nonetheless, the utility of these tests or ultrasound screening may be an important avenue of exploration in future studies. Additionally, radial artery occlusion is an important, albeit rare, complication of TRA which can complicate future procedures and has the potential to affect upper extremity function. Emerging research, however, demonstrates that while upper extremity function may be impacted in the short-term, it is not in the long-term [33]. RA occlusion was not systematically assessed prospectively in the current study and would need to be addressed in future study of TRA. Lastly, many operators may be reluctant to use pRBA due to the potential pain associated with the use of contrast dye. While this is not something that has been studied to date, it would be an essential addition to any future randomized prospective trials. 5. Conclusions By providing an optimized view of the radial artery prior to the start of procedure, pRBA allows an operator to detect potential complications early and establish strategies for traversing difficult anatomy. pRBA offers a practical method for reducing in-procedure complications during transradial cardiac catheterization and intervention. When difficult radial artery anatomy is encountered, pRBA offers reduced overall procedure time and time needed to cross anatomic lesions as well as reductions in complications and extra catheter utilization. Taken together, pRBA may help reduce barriers to the adoption of TRA in the United States, and improve outcomes during and following cardiac catheterization and intervention.
Supplementary data to this article can be found online at https://doi. org/10.1016/j.carrev.2019.10.005.
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Please cite this article as: J.A. Kern, F.A. Medina, L. Lee, et al., Use of prospective radiobrachial angiography in transradial cardiac catheterization and intervention, Cardiovascular Revascularization Medicine, https://doi.org/10.1016/j.carrev.2019.10.005