A randomized controlled trial to assess operator radiation exposure from cardiac catheterization procedures using RAD BOARD® with standard pelvic shielding versus standard pelvic shielding alone.

OBJECTIVE: To study radiation exposure to the primary operator during diagnostic cardiac catheterizations using a radio-dense RAD BOARD® radial access arm board. BACKGROUND: The use of radial access for catheterization in the United States has increased from 1% in 2007 to 41% in 2018. Compared to femoral access, operator radiation exposure from radial access is similar or higher. The RAD BOARD radio-dense radial access arm board has been marketed as reducing radiation to operators by 44%. MATERIALS AND METHODS: We randomized 265 patients undergoing catheterization via right radial access to standard pelvic lead drape shielding (nonboard group) versus RAD BOARD in addition to pelvic drape (board group). Operator radiation exposure was measured using Landauer Microstar nanoDot™ badges worn by the operator. RESULTS: Board and nonboard groups were similar with respect to demographic and procedural variables. Mean operator dose per case was higher in the board group (.65mSieverts) than in the nonboard group (.56mSieverts, P < 0.0001). In sub-group analyses, radiation doses were higher in the board group compared to the nonboard group in patients across all body mass index groups (P < 0.03). In multivariate analysis, operator dose correlated with use of the RAD BOARD more closely than any other variable (P < 0.001). Post hoc analysis of the table setup with RAD BOARD revealed that use of RAD BOARD prevented placement of a shield normally inserted into the top of the standard below-table shield. CONCLUSION: RAD BOARD with the pelvic shield was associated with higher radiation exposure to the operator compared with pelvic shield alone, likely due to inability to use standard radiation shielding along with the RAD BOARD.

Impact of pre-hospital electrocardiograms on time to treatment and one year outcome in a rural regional ST-segment elevation myocardial infarction network.

BACKGROUND: Pre-hospital electrocardiograms (ECGs) are believed to reduce time to reperfusion in ST Segment Elevation Myocardial Infarction (STEMI) patients. Little is known of their impact on clinical outcomes in a rural setting. Geisinger regional STEMI network provides percutaneous coronary intervention (PCI) care to over a 100-mile radius in rural central Pennsylvania. METHODS: A retrospective analysis identified 280 consecutive STEMI patients treated with PCI between 1/1/09 and 8/31/11. Comparison between two STEMI groups was performed: 205 patients who were taken by the emergency medical system (EMS) to the nearest hospital (a non-PCI center), underwent an ECG revealing a STEMI, and were transported immediately to Geisinger Medical Center (GMC) for PCI (transfer group) versus 75 patients in whom a pre-hospital ECG was obtained and who were transported by EMS directly to Geisinger for PCI, bypassing the nearest hospital that did not perform PCI (the pre-hospital ECG group). RESULTS: Analysis of baseline characteristics revealed that the pre-hospital ECG cohort was older (65 vs. 60 years); had a higher percentage of previous myocardial infarctions (MI) (28% vs. 15%), heart failure (11% vs. 4%), and prior PCI (23% vs. 13%; p < 0.05 all comparisons). Median time from EMS contact to pre-hospital ECG in the pre-hospital ECG group was 5 minutes; from pre-hospital ECG to the GMC ED was 34 minutes. Median time from first medical contact (EMS contact) to reperfusion (device activation) was 79 versus 157 minutes (P < 0.001), respectively in pre-hospital ECG vs. transfer groups. Mortality in the two groups at 1 year was 4.1% in the pre-hospital ECG group versus 8.3% in the transfer group (P-value = 0.34). After adjusting for the difference in age between the two groups, the 62% reduction in 1 year mortality associated with having obtained a pre-hospital ECG was still not statistically significant (P-value = 0.19). CONCLUSION: In a rural regional STEMI network, pre-hospital ECGs decreased time from first medical contact to reperfusion by 50% and were associated with an excellent clinical outcome at 1 year. © 2016 Wiley Periodicals, Inc.

Does Preoperative Platelet Function Predict Bleeding in Patients Undergoing Off Pump Coronary Artery Bypass Surgery?

OBJECTIVE: We sought to examine the relationship between preoperative platelet function and perioperative bleeding in patients undergoing CABG. BACKGROUND: There are many ways to measure platelet aggregability. Little is known about their correlations with one another, or with bleeding. METHODS: We prospectively studied 50 patients undergoing a first isolated off-pump CABG. Thirty-four were exposed to a thienopyridine prior to surgery; 16 were not. Preoperative platelet function was measured by VerifyNow®, TEG®, AggreGuide™, Plateletworks®, vasodilator-stimulated phosphoprotein (VASP) phosphorylation, and light transmission aggregometry. Bleeding was assessed 2 ways: drop from pre- to nadir postoperative hematocrit, and chest tube drainage. Correlation coefficients were calculated using Spearman's rank-order correlation. RESULTS: Mean age was 62 years. Patient characteristics and surgical details were similar between the thienopyridine-exposed and non-exposed patients. The correlation coefficients between the 4 point-of-care platelet function measurements and hematocrit change ranged from -0.2274 to 0.2882. Only Plateletworks® correlated with drop in hematocrit (r = 0.2882, P = 0.0470). The correlation coefficients between each of the 4 point-of-care platelet function tests and the chest tube drainage were also poor, ranging from -0.3073 to 0.2272. Both AggreGuide™ (r = -0.3073, P = 0.0317) and VASP (r = -0.3187, P = 0.0272) were weakly but significantly correlated with chest tube drainage. The correlation among the 4 point-of-care platelet function measurements was poor, with coefficients ranging from -0.2504 to 0.1968. CONCLUSIONS: We observed little correlation among 4 platelet function tests, and between those assays and perioperative bleeding defined 2 different ways. Whether any of these assays should be used to guide decision making in individual patients is unclear.

Safety of coronary angiography and percutaneous coronary intervention via the radial versus femoral route in patients on uninterrupted oral anticoagulation with warfarin.

OBJECTIVE: To evaluate access site and other bleeding complications associated with radial versus femoral access in patients receiving oral anticoagulation (OAC) with warfarin. BACKGROUND: Patients receiving OAC with warfarin undergoing coronary angiography and percutaneous coronary intervention (PCI) may have OAC continued despite the risk of bleeding. To what extent arterial access site impacts bleeding in such patients is not well studied. METHODS: Over 6 years, we identified 255 consecutive patients in whom warfarin was continued who underwent coronary angiography with an international normalized ratio >1.8. A total of 97 patients also underwent PCI at the same setting (27% femoral vs 73% radial). The primary outcome was Bleeding Academic Research Consortium bleeds; a secondary end point was frequency of access site complications in the 72 hours post-PCI. Complications were evaluated based on the initial access site attempted. RESULTS: Minimal baseline clinical characteristics differences existed between the groups. International normalized ratio was significantly higher in the radial group (2.42 ± 0.67 vs 2.24 ± 0.49, P = .02). Bivalirudin use was greater during radial PCI than femoral (76% vs 42%, P < .05), whereas unfractionated heparin alone was greater during femoral PCI than radial (46% vs 18%, P < .05). No significant difference was seen in the primary end point between femoral (2.8%) and radial (1.6%, P = .54) during coronary angiography alone. However, PCI via the femoral artery had significantly more Bleeding Academic Research Consortium bleeding (19.2% vs 1.4%, P = .005) and transfusions (15% vs 0%, P = .004) than via the radial artery. Patients who underwent PCI using radial access were less likely to have any vascular or bleeding complications (1% vs 23%, P = .001). CONCLUSIONS: Patients who underwent coronary angiography during uninterrupted OAC had similar bleeding rates regardless of access site. However, when PCI was performed, radial access was associated with fewer bleeding and vascular complications than the femoral approach. CONDENSED ABSTRACT: We retrospectively identified 255 consecutive patients on warfarin who underwent coronary angiography, 97 of whom underwent a percutaneous coronary intervention. The data reveal a reduction in Bleeding Academic Research Consortium bleeds (1.6% vs 8.1%, P = .02) with radial versus femoral access. The radial approach was associated with an overall lower rate of any vascular or bleeding complication than the femoral approach during percutaneous coronary intervention (1% vs 23%, P = .001).

The current state of medical simulation in interventional cardiology: a clinical document from the Society for Cardiovascular Angiography and Intervention's (SCAI) Simulation Committee.

OBJECTIVES: To assess the current use and application of simulators in interventional cardiology. BACKGROUND: Despite a paucity of data on the efficacy of simulation in medicine, cardiovascular simulation training is now a mandated part of cardiovascular fellowship training. Additionally, simulators have been endorsed by the Food and Drug Administration as a way to teach physicians new and novel procedures. We sought to establish the current use of simulators in cardiovascular medicine. METHODS: A systematic review was done of available training programs, and currently existing data regarding simulation training. A panel of experts was convened to review this data and provide recommendations as how simulation should be used in the field of interventional cardiology. RESULTS: This document provides a comprehensive review of the current state of simulation and how we as a society must formulate well validated studies to more closely examine and explore how this technology can be further studied and validated. CONCLUSIONS: Simulation will likely take on a larger role in cardiovascular training and maintenance of certification, but at the current time lacks a large body of evidence for its use.

Prospective, comprehensive assessment of cardiac troponin T testing after coronary artery bypass graft surgery.

BACKGROUND: The significance and clinical role of cardiac troponin testing after coronary artery bypass grafting remain unclear. METHODS AND RESULTS: Cardiac troponin T (cTnT) was measured during the first 24 hours after coronary artery bypass graft surgery in 847 consecutive patients. Only 17 patients (2.0%) had new Q waves or left bundle-branch block after surgery; however, cTnT elevation was observed in nearly all subjects, with a median cTnT concentration of 1.08 ng/mL overall. Direct predictors of postoperative cTnT values included preoperative myocardial infarction (P<0.001), preoperative intraaortic balloon pump (P<0.001), intraoperative/postoperative intraaortic balloon pump (P<0.001), number of distal anastomoses (P=0.005), bypass time (P<0.001), and number of intraoperative defibrillations (P=0.009), whereas glomerular filtration rate (P<0.001), off-pump coronary artery bypass grafting (P=0.003), and use of warm cardioplegia (P=0.02) were inversely associated with cTnT values. A linear association was seen between cTnT levels and length of stay and ventilator hours, and in an analysis adjusted for the Society for Thoracic Surgery Risk Model, cTnT remained independently prognostic for death (odds ratio, 3.20; P=0.003), death or heart failure (odds ratio, 2.04; P=0.008), death or need for vasopressors (odds ratio, 2.70; P<0.001), and the composite of all 3 (odds ratio, 2.57; P<0.001). In contrast to consensus-endorsed cTnT cut points for postoperative evaluation, a cTnT <1.60 ng/mL had a negative predictive value of 93% to 99% for excluding various post-coronary artery bypass graft surgery complications. CONCLUSIONS: cTnT concentrations after coronary artery bypass graft surgery are nearly universally elevated, are determined by numerous factors, and are independently prognostic for impending postoperative complications when used at appropriate cut points.

Natriuretic peptide testing for heart failure therapy guidance in the inpatient and outpatient setting.

Acutely destabilized heart failure is one of the most common diagnoses in the modern health care system. It has high hospital readmission rates and significant short-, medium-, and long-term mortality, likely due to misdiagnosis or failure to assess adequate treatment before discharge. Cardiac biomarkers such as B-type natriuretic peptide and its amino terminal cleavage equivalent N-terminal fragment have rapidly become one of the key tools in the diagnosis and guidance of heart failure therapy. In this article, we shall review the data on the current use of the natriuretic peptides for the diagnosis, prognosis, and management of heart failure in both the outpatient and inpatient settings.

Clinical uncertainty, diagnostic accuracy, and outcomes in emergency department patients presenting with dyspnea.

BACKGROUND: Dyspnea is a common complaint in the emergency department (ED) and may be a diagnostic challenge. We hypothesized that diagnostic uncertainty in this setting is associated with adverse outcomes, and amino-terminal pro-B-type natriuretic peptide (NT-proBNP) testing would improve diagnostic accuracy and reduce diagnostic uncertainty. METHODS: A total of 592 dyspneic patients were evaluated from the ProBNP Investigation of Dyspnea in the Emergency Department (PRIDE) study. Managing physicians were asked to provide estimates from 0% to 100%of the likelihood of acutely destabilized heart failure (ADHF). A certainty estimate of either 20% or lower or 80% or higher was classified as clinical certainty, while estimates between 21% and 79% were defined as clinical uncertainty. Associations between clinical uncertainty,hospital length of stay, morbidity, and mortality were examined. The diagnostic value of clinical judgment vs NT-proBNP measurement was compared across categories of clinical certainty. RESULTS: Clinical uncertainty was present in 185 patients (31%), 103 (56%) of whom had ADHF. Patients judged with clinical uncertainty had longer hospital length of stay and increased morbidity and mortality,especially those with ADHF. Receiver operating characteristic analysis of clinical judgment yielded an area under the curve (AUC) of 0.88 in the clinical certainty group and 0.76 in the uncertainty group (P<.001); NT-proBNP testing alone in these same groups had AUCs of 0.96 and 0.91, respectively. The combination of clinical judgment with NT-proBNP testing yielded improvements in AUC. CONCLUSIONS: Among dyspneic patients in the ED, clinical uncertainty is associated with increased morbidity and mortality, especially in those with ADHF.The addition of NT-proBNP testing to clinical judgment may reduce diagnostic uncertainty in this setting.

Soluble ST2 plasma concentrations predict 1-year mortality in acutely dyspneic emergency department patients with pulmonary disease.

We evaluated the association between ST2 concentrations and mortality at 1 year in 231 acutely dyspneic patients with pulmonary diseases seen in the emergency department. Blood concentrations of ST2 were ascertained; using 1-year survival as the reference standard, receiver operating characteristic curves with resultant area under the curve (AUC) were measured. Cox proportional hazards models identified independent predictors of 1-year death. Hazard curves compared rates of death as a function of ST2 concentration. Concentrations of ST2 were significantly higher in patients with pulmonary diseases compared with 153 subjects without cardiopulmonary disease (0.23 vs 0.11 ng/mL; P = .01). Among patients with pulmonary diseases, concentrations of ST2 were higher among decedents compared with survivors (1.14 ng/mL vs 0.19 ng/mL; P < .001). ST2 had an AUC of 0.72 as a predictor of death (P < .0001). An ST2 of 0.20 ng/mL had a hazard ratio for death of 6.1 (95% confidence interval, 1.8-21.0; P = .004). Compared with patients with lower ST2 concentrations, mortality rates for patients with an enrollment ST2 of 0.20 ng/mL or more diverged early and rose progressively in 1 year (P < .001). ST2 concentrations are frequently elevated in acute pulmonary diseases and are markedly prognostic for death by 1 year.

Multi-center validation of the Response Biomedical Corporation RAMP NT-proBNP assay with comparison to the Roche Diagnostics GmbH Elecsys proBNP assay.

BACKGROUND: NT-proBNP measurements aid in the evaluation of patients with suspected heart failure (HF) and may facilitate risk stratification in patients with HF and acute coronary syndrome (ACS). Point-of-care (POC) assays may provide more timely results and potentially improve patient outcomes. METHODS: We evaluated the analytical performance of the Response Biomedical Corporation whole blood RAMP amino-terminal pro-B type natriuretic peptide (NT-proBNP) POC assay compared to the Roche Elecsys proBNP (NT-proBNP) assay. RESULTS: Intra-day and total imprecision (% CV) ranged from 5.5% to 10.3% at 140, 449 and 1675 ng/L. The lowest concentration that yields a 20% CV was 57 ng/L. The lower limit of detection was 18 ng/L. The upper limit of linearity was validated to 23,428 ng/L with an average recovery of 95%. Correlation by Passing and Bablok regression yielded RAMP=1.01 Elecsys+14.6, r=0.98 (n=540; range of Elecsys values <5 to >35,000). Concordance of RAMP versus Elecsys using cut-offs of 125 ng/L for subjects <75 years and 450 ng/L for subjects > or =75 was 92% (95% CI 89-94%) for a group consisting of 127 apparently healthy individuals and 208 non-healthy subjects without HF, and 99% (95% CI 97-100%) for patients with HF, using the New York Heart Association (NYHA) functional classification. Overall, 80%, 87%, 97% and 100% of the RAMP results and 77%, 85%, 96% and 100% of the Elecsys results were greater than the age appropriate cut-off for NYHA I, II, III or IV groups. For both the RAMP and Elecsys results, the median NT-proBNP value was statistically correlated (increasing) with NYHA I, II, III or IV groups, respectively (p<0.0001), with no significant difference between the two methods. CONCLUSIONS: The POC Response Biomedical RAMP NT-proBNP assay provides comparable results that measured on the FDA cleared Roche Elecsys central laboratory platform.

Elevation of myeloperoxidase in conjunction with cardiac-specific markers after marathon running.

Cardiac-related death has been reported following strenuous exercise, and biochemical markers predicting adverse outcomes would be useful. Despite the fact the myeloperoxidase (MPO) release may precede myocardial injury and identify at-risk patients earlier than traditional markers, information on the effects of marathon running on MPO levels is lacking. We measured MPO in conjunction with the creatine kinase MB fraction (CK-MB), myoglobin, troponin T (TnT), and N-terminal B-type natriuretic peptide (NT-proBNP) in 24 athletes before and after a marathon race. Of the 24 athletes, 22 (92%) had an increased MPO level, and the mean MPO level increased from 281.44 pmol/L to 785.21 pmol/L (P < .0001). Results for 14 (58%) of the athletes reached or exceeded the manufacturer's recommended clinical threshold. The increases in CK-MB, myoglobin, TnT, and NT-proBNP also reached statistical significance. Although the elevation in MPO most likely represents a systemic inflammatory response, the concurrent elevations in TnT and NT-proBNP suggest that myocardial injury cannot be excluded.

Comparison of bare-metal and drug-eluting stents in patients with chronic kidney disease (from the NHLBI Dynamic Registry).

Patients with chronic kidney disease (CKD) have a disproportionate burden of coronary artery disease and commonly undergo revascularization. The role and safety of percutaneous coronary intervention (PCI) using drug-eluting stents (DESs) verses bare-metal stents in patients with CKD not on renal replacement therapy has not been fully evaluated. This study investigated the efficacy and safety of DES in patients with CKD not on renal replacement therapy. Patients were drawn from the National Heart, Lung, and Blood Institute Dynamic Registry and were stratified by renal function based on estimated glomerular filtration rate (GFR). Of the 4,157 participants, 1,108 had CKD ("low GFR" <60 ml/min/1.73 m(2)), whereas 3,049 patients had normal renal function ("normal GFR" ≥60 ml/min/1.73 m(2)). For each stratum of renal function we compared risk of death, myocardial infarction, or repeat revascularization between subjects who received DESs and bare-metal stents at the index procedure. Patients with low GFR had higher 1-year rates of death and myocardial infarction and a decreased rate of repeat revascularization compared to patients with normal GFR. Use of DESs was associated with a decreased need for repeat revascularization in the normal-GFR group (adjusted hazard ratio 0.63, 95% confidence interval 0.50 to 0.79, p <0.001) but not in the low-GFR group (hazard ratio 0.69, 95% confidence interval 0.45 to 1.06, p = 0.09). Risks of death and myocardial infarction were not different between the 2 stents in either patient population. In conclusion, presence of CKD predicted poor outcomes after PCI with high rates of mortality regardless of stent type. The effect of DES in decreasing repeat revascularization appeared to be attenuated in these patients.

The impact of amino-terminal pro-brain natriuretic peptide testing on hospital length of stay and morbidity in patients with acute decompensated heart failure.

CONTEXT: In clinical trials, N-terminal pro-brain natriuretic peptide (NT-proBNP) testing has been shown to be valuable for diagnosis and triage of patients with acute decompensated heart failure. It is not yet clear what benefits might be expected from the initiation of NT-proBNP testing in an everyday clinical setting. OBJECTIVE: To determine the effects of NT-proBNP testing on hospital length of stay as well as on 60-day morbidity and mortality in patients with acute decompensated heart failure before and after the test was implemented in the clinical laboratory. DESIGN: We measured hospital length of stay and 60-day morbidity and mortality rates among patients with acute decompensated heart failure admitted before and after initiation of NT-proBNP testing in our hospital. Differences in demographics between preimplementation and postimplementation groups were compared with the chi2 test for categorical variables and the Wilcoxon rank sum test for continuous variables. Comparison between the hospital length of stay for each group was evaluated using the Mann-Whitney U test. Differences in rates of rehospitalization or death at 60 days following presentation were assessed using chi2 cross-tabulation. RESULTS: Patients in the postimplementation group had similar clinical features as those in the preimplementation group. The hospital length of stay for patients in the postimplementation study group decreased both with respect to mean (1.86-day reduction) and median (1.3-day reduction) hospital stay (both, P = .03). Additionally, significantly lower rates of death (6.6% absolute risk reduction, P = .01), rehospitalization (12.1% absolute risk reduction, P = .005), and the composite of the 2 rates (18.7% absolute risk reduction, P = .008) were found following initiation of NT-proBNP testing. CONCLUSIONS: Implementation of NT-proBNP testing may result in significant reductions in hospital length of stay as well as improvements in rates of morbidity and mortality in patients with acute decompensated heart failure.