Abstract: Background. Use of a universal diagnostic catheter may decrease procedural time and catheter-exchange related spasm when compared with a dual-catheter strategy. The aim of this study was to identify preprocedural predictors of failure to complete a coronary angiogram with a universal catheter alone. Methods. Consecutive patients (n = 782) who underwent a right transradial/transulnar coronary angiogram with a single operator were retrospectively reviewed. Multivariable predictors of failure to complete the procedure with a universal catheter alone were identified using logistic regression analysis and presented as odds ratio (OR) and 95% confidence interval (CI). Results. Of the study population (n = 558), a total of 216 (38.7%) required exchange to a coronary-specific catheter (44.4% for right coronary artery alone, 25.5% for left coronary artery alone, 30.1% for both) and 342 (61.3%) underwent angiography with a universal catheter alone. Patients who required a catheter exchange were more likely to have the following characteristics compared with patients who underwent an angiogram with a universal catheter alone: age >75 years (27.3% vs 16.4%; P<.01), female sex (34.3% vs 23.1%; P<.01), diabetes mellitus (50.0% vs 38.3%; P<.01), hypertension (88.0% vs 74.6%; P<.001), and chronic kidney disease (29.2% vs 17.8%; P<.01). After multivariable adjustment, age >75 years (OR, 1.92; 95% CI, 1.21-3.04), female sex (OR, 1.94; 95% CI, 1.20-3.14), hypertension (OR, 2.08; 95% CI, 1.22-3.57), and chronic kidney disease (OR, 1.58; 95% CI, 1.01-2.46) predicted failure of a universal catheter alone to complete angiography. Conclusion. Consideration may be given to use an initial dual-catheter strategy if one or more of the following are present: elderly age, female sex, hypertension, and chronic kidney disease.
J INVASIVE CARDIOL 2019 September 15 (Epub Ahead of Print).
Key words: coronary angiography, universal catheter, transradial artery access
The utility of transradial artery access (TRA) for cardiac catheterization procedures has increased in the United States over time.1 TRA for invasive coronary angiography and intervention results in fewer bleeding and vascular access-site complications when compared with transfemoral artery access (TFA).2,3 However, TRA is associated with longer procedure times and more radiation exposure when compared with TFA, particularly in the setting of less-experienced operators and/or more complex patient anatomy.4-7 Optimization of TRA may include appropriate catheter selection, as limiting the number of catheters used for coronary angiography may decrease the incidence of radial artery spasm, procedure time, and radiation exposure.8-10 Traditionally, dedicated catheters are used for separate cannulation of the right coronary artery (RCA) and left coronary artery (LCA). These dedicated catheters require time for an exchange and may increase the risk of spasm. Universal TRA catheters allow single-pass access to the RCA and LCA and may result in shorter fluoroscopy time and shorter procedure time in comparison with dedicated catheters.9-12 However, use of universal catheters may also require catheter or access-site changes in certain patients and subsequently increase procedure time and radiation exposure when compared with dedicated catheters.12-14
The aim of this study is to identify which patient-related characteristics may a priori identify patients who are less likely to undergo a diagnostic invasive coronary angiogram with a universal catheter alone and require exchange to an alternative dedicated catheter. Identification of these factors may allow better patient selection for the universal-catheter versus dedicated-catheter strategy in TRA and increase the procedure success rate without an increase in procedure time or radiation exposure.
Study population. This is a retrospective analysis of 782 consecutive patients who underwent a diagnostic coronary angiogram between January 1, 2015 and June 13, 2017 by a single high-volume TRA operator with >3 years of experience with a universal catheter. Procedures were performed in conjunction with trainees (primarily an interventional cardiology fellow) at three sites of a tertiary-care academic medical center. Procedures performed via TFA approach (including coronary angiography prior to balloon aortic valvuloplasty or hemodynamic support device placement) (n = 32) were excluded. Of the remaining patients who underwent TRA or transulnar artery approach (n = 750), if a patient underwent multiple diagnostic coronary angiograms during the study period, only the first was included and subsequent procedures were excluded (n = 38). Patients were also excluded if the presentation was ST-segment elevation myocardial infarction (n = 37) or if a universal catheter was not initially attempted (most common reasons were patient referred from an outside hospital for a planned percutaneous coronary intervention and initial use was a dedicated guiding catheter or presence of pedicled left internal mammary artery and initial use was an internal mammary catheter from the left radial artery) (n = 117) (Figure 1). The study was approved by the institutional review boards at New York University School of Medicine, Bellevue Hospital Center, and the Manhattan Veterans Affairs Hospital, all of which are tertiary cardiac referral centers.
Variables of interest. The electronic medical record system was queried for covariables and outcomes of interest. History of coronary artery disease was defined as prior myocardial infarction, ≥70% diameter stenosis in an epicardial artery ≥2 mm in diameter on a prior coronary angiogram report, prior percutaneous coronary intervention, or prior coronary artery graft bypass surgery. Presence of diabetes mellitus was defined as documented reported history of use of glucose-lowering medications or hemoglobin A1c ≥6.5%. Hypertension and dyslipidemia were defined as documented reported history of or use of antihypertensive or cholesterol-lowering therapy, respectively. Cerebrovascular disease was defined as prior stroke or transient ischemic attack. Relevant laboratory values that were closest to the time of the catheterization within 24 hours of the procedure were evaluated, including glomerular filtration rate, which was used to determine presence of ≥ stage 3 chronic kidney disease. Systolic and diastolic blood pressure at the start of the procedure as documented in the catheterization reporting system were recorded. Procedures were performed with 5 Fr catheters.
Endpoint. The endpoint of interest was defined as failure to complete the coronary angiogram with a universal catheter alone, ie, unable to cannulate either the RCA or LCA and requiring exchange to a dedicated coronary catheter after initial attempt with a universal catheter.
Statistical analyses. Categorical variables are presented as frequency (proportion) and compared using the Fisher’s exact test or Chi-square test. Continuous variables are presented as median (interquartile range [IQR]) and compared using the Mann-Whitney U test. Multivariable predictors of failure to complete the procedure with a universal catheter alone were identified using logistic regression analysis and presented as odds ratio (OR) and 95% confidence interval (CI). Candidates for the model were based on a priori biomedical knowledge (age >75 years, female sex, short stature, and hypertension) and additional variables with a two-sided significance level <.10 on univariate analysis (diabetes mellitus, dyslipidemia, chronic kidney disease, history of tobacco use). A second multivariable model was created with number of antihypertensive medications rather than hypertension. Statistical significance was defined as a two-sided alpha level of 0.05. Statistical analyses were conducted using SPSS Statistics, version 23 (IBM).
Study population. Of the 558 patients who met study criteria, a total of 216 (38.7%) required exchange to a coronary-specific catheter, while 342 (61.3%) successfully underwent coronary angiography with a universal catheter for both the LCA and RCA. Of the catheterizations that failed to be cannulated by the universal catheter initially, 44.4% required exchange for RCA alone, 25.5% required exchange for LCA alone, and 30.1% required exchange for both the RCA and LCA.
Baseline characteristics. Baseline characteristics are shown in Table 1. Patients who required a catheter exchange were more likely to be older and female when compared with patients who underwent a coronary angiogram with a universal catheter alone. In addition, patients who required a catheter exchange were more likely to have diabetes mellitus, hypertension, and chronic kidney disease than patients who underwent a coronary angiogram with a universal catheter alone. The use of insulin in patients with diabetes mellitus and median serum glucose levels were also significantly higher in patients who required a catheter exchange when compared with those who successfully underwent a complete angiogram with a universal catheter alone. Furthermore, the number of antihypertensive medications and median systolic blood pressure (but not diastolic blood pressure) were also significantly higher in patients who required a catheter exchange when compared with those who successfully underwent a complete angiogram with a universal catheter alone.
Procedural data. The proportion of patients who underwent a diagnostic coronary angiogram with ad hoc percutaneous coronary intervention (19.9% vs 21.3%; P=.75) and the proportion of patients who underwent a diagnostic coronary angiogram with a right heart catheterization (16.2% vs 12.9%; P=.32) did not differ between the group that required a catheter exchange versus the group that completed the angiogram with a universal catheter alone. However, patients who required a catheter exchange had more contrast use (70 mL [IQR, 46-117 mL] vs 53 mL [IQR, 39-98 mL]; P<.01) and longer fluoroscopy time (12.1 min [IQR, 7.0-19.2 min] vs 5.1 min [IQR, 3.0-10.0 min]; P<.001) than those who completed the angiogram with a universal catheter alone. Radiation exposure as measured by dose area product did not differ between the two groups (2646 Gy•cm2 [IQR, 1078-12,327 Gy•cm2] vs 3174 Gy•cm2 [IQR, 818-8664 Gy•cm2]; P=.15).
Predictors of failure to complete angiography with a universal catheter alone. After multivariable adjustment, age ≥75 years, female sex, hypertension, and chronic kidney disease predicted failure of a universal catheter alone to complete angiography (Table 2). Goodness-of-fit (Pearson Chi-square statistic P=.52) and model fitting information (P<.001) demonstrated that the model fits the data well. The ROC-derived c-statistic was 0.66. In the alternate model, number of antihypertensive medications used did not emerge as a significant predictor of failure of a universal catheter alone to complete angiography (Table 2).
TRA coronary angiography using a universal catheter strategy enables operators to bypass procedural steps and potentially decrease procedure time, which has potential implications in the setting of urgent procedures and risk of radial artery spasm and subsequent access-site crossover rates during catheter exchange. However, gaining the benefit of fewer procedural steps and less time is contingent on the success of the universal catheter. This study demonstrates that preprocedural characteristics of age ≥75 years, female sex, hypertension, and chronic kidney disease predict failure to complete an invasive coronary angiogram via TRA with a universal catheter alone, which is also associated with increased contrast use and longer fluoroscopy time. Identification of preprocedural predictors of failure may improve patient selection for a universal versus dual-catheter strategy.
Previous studies have identified benefits to the use of a universal catheter to cannulate the coronary arteries via TRA, including shorter procedural time, less radiation exposure, and lower rate of radial artery spasm. A small retrospective analysis of patients who underwent primary TRA percutaneous coronary intervention for uncomplicated ST-segment elevation myocardial infarction demonstrated significantly shorter door-to-balloon time and puncture-to-balloon time, as well as fewer catheters used with a universal guiding catheter versus a dual-catheter strategy.9 Several larger randomized studies of patients undergoing TRA diagnostic coronary angiography also demonstrated shorter procedure time, shorter fluoroscopy time, and lower rate of severe radial artery spasm with a universal versus dual-catheter strategy.10-12 However, at least one recent large randomized trial demonstrated longer procedure and fluoroscopy times, suggesting that the benefits of universal catheter use during TRA coronary angiography are not consistent.14 Furthermore, several of these studies also demonstrated greater use of supplemental catheters and higher rates of crossover or failure to complete coronary angiography with a universal catheter alone.12-14 One study did not demonstrate a difference in procedure time between the universal and dual-catheter strategies except when additional time for changing the universal catheter was taken into account.12 Therefore, there are data to suggest the importance of identifying patients who were unlikely to complete TRA coronary angiography with a universal catheter alone a priori.
The characteristics we identify as predictors of failure to complete angiography with a universal catheter alone overlap with predictors of access-site failure during TRA. The TALENT study demonstrated that radiation exposure was greater in the right versus left TRA groups in patients ≥70 years, which, in turn, was an independent predictor of right subclavian artery tortuosity.15 Furthermore, while one large retrospective analysis identified older age, female sex, shorter stature, hypertension, nonsmoker status, and a higher body mass index as independent predictors of severe right subclavian artery tortuosity, another large retrospective study identified age ≥75 years, female sex, short stature, and history of coronary artery bypass graft surgery as predictors of TRA failure.16,17 A more recent retrospective analysis demonstrated only age >75 years and female sex as independent predictors of TRA failure.18 It is interesting to note that although a few studies demonstrated short stature as a predictor of TRA failure, this patient-related characteristic did not predict failure to complete coronary angiography with a universal catheter alone in the current study. Of interest, chronic kidney disease did emerge as a predictor of universal catheter failure in the current study. Prior TRA studies have significantly under-represented the chronic kidney disease population. However, the current study evaluated procedures performed by a TRA operator who routinely performs coronary angiography via TRA in chronic kidney disease patients, which accounts for the slightly >20% prevalence of chronic kidney disease in the current study. Together, the data suggest that the mechanism of failure to complete coronary angiography with a universal catheter alone may be deformation of the aortic root.
Multiple studies have demonstrated better opacification of the RCA with the universal catheter, while there was either no difference or compromised opacification and less successful angiography of the LCA with the universal catheter when compared to the dual-catheter strategy.10-12 Interestingly, the current study showed a relatively high rate of failure to complete TRA coronary angiography with a universal catheter alone and that this was largely due to failure to cannulate the RCA. However, degree of opacification was not evaluated. Furthermore, unlike prior studies, the current study was enriched in a population with multiple co-morbidities, including diabetes, chronic kidney disease (15% of which were on dialysis), and hypertension on multiple antihypertensive medications.
Study limitations. First, the limitations of the current study include those inherent to a retrospective observational study design, and there may be confounding variables not accounted for in the current multivariable analyses. Second, given that the aim of this study was to evaluate preprocedural characteristics for procedural planning, anatomical characteristics such as tortuosity and aorta size were not included in the model. Third, although the patients included in the study were from one of three different referral populations (a private academic institution, a city hospital, and a Veterans Affairs hospital), findings based on a single operator’s experience may not be generalizable. Nonetheless, this is the first study to determine clinical predictors of failure to cannulate the coronary arteries with a universal catheter alone.
Baseline characteristics that predict failure to complete a TRA invasive coronary angiogram with a universal catheter alone include age ≥75 years, female sex, hypertension, and chronic kidney disease. A prospective study to evaluate whether these predictors may help refine patient selection for a universal-catheter approach and subsequently decrease procedural time and/or radiation exposure is warranted. Future studies may consider randomizing patients to an initial dual-catheter strategy or a tailored approach of upfront universal versus dual-catheter strategy based on preprocedural characteristics.
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From the 1Department of Medicine (Cardiology), New York University School of Medicine, New York, New York; and 2Department of Medicine (Cardiology), Veterans Affairs New York Harbor Health Care System, Manhattan Campus, New York, New York.
Funding: This study was investigator initiated with no external funding. Dr Shah was supported in part by the Biomedical Laboratory Research & Development Service of the VA Office of Research and Development (iK2CX001074).
Disclosure: The authors have completed and returned the ICMJE Form for Disclosure of Potential Conflicts of Interest. Dr Shah is on the advisory boards for Phillips Volcano and Radux Devices; consultant for Terumo Medical. Dr Coppola is on the advisory board for Radux Devices; consultant for Terumo Medical. The remaining authors report no conflicts of interest regarding the content herein.
Manuscript submitted April 26, 2019, provisional acceptance given May 1, 2019, final version accepted May 7, 2019.
Address for correspondence: Binita Shah, MD, MS, VA New York Harbor Health Care System, 423 East 23rd Street, 12W-12023, New York, NY 10010. Email: firstname.lastname@example.org