Central Core Laboratory versus Site Interpretation of Coronary CT Angiography: Agreement and Association with Cardiovascular Events in the PROMISE Trial.

Purpose To assess concordance and relative prognostic utility between central core laboratory and local site interpretation for significant coronary artery disease (CAD) and cardiovascular events. Materials and Methods In the Prospective Multicenter Imaging Study for Evaluation of Chest Pain (PROMISE) trial, readers at 193 North American sites interpreted coronary computed tomographic (CT) angiography as part of the clinical evaluation of stable chest pain. Readers at a central core laboratory also interpreted CT angiography blinded to clinical data, site interpretation, and outcomes. Significant CAD was defined as stenosis greater than or equal to 50%; cardiovascular events were defined as a composite of cardiovascular death or myocardial infarction. Results In 4347 patients (51.8% women; mean age ± standard deviation, 60.4 years ± 8.2), core laboratory and site interpretations were discordant in 16% (683 of 4347), most commonly because of a finding of significant CAD by site but not by core laboratory interpretation (80%, 544 of 683). Overall, core laboratory interpretation resulted in 41% fewer patients being reported as having significant CAD (14%, 595 of 4347 vs 23%, 1000 of 4347; P < .001). Over a median follow-up period of 25 months, 1.3% (57 of 4347) sustained myocardial infarction or cardiovascular death. The C statistic for future myocardial infarction or cardiovascular death was 0.61 (95% confidence interval [CI]: 0.54, 0.68) for the core laboratory and 0.63 (95% CI: 0.56, 0.70) for the sites. Conclusion Compared with interpretation by readers at 193 North American sites, standardized core laboratory interpretation classified 41% fewer patients as having significant CAD. © RSNA, 2017 Online supplemental material is available for this article. Clinical trial registration no. NCT01174550.

Effect of Omega-3 Acid Ethyl Esters on Left Ventricular Remodeling After Acute Myocardial Infarction: The OMEGA-REMODEL Randomized Clinical Trial.

BACKGROUND: Omega-3 fatty acids from fish oil have been associated with beneficial cardiovascular effects, but their role in modifying cardiac structures and tissue characteristics in patients who have had an acute myocardial infarction while receiving current guideline-based therapy remains unknown. METHODS: In a multicenter, double-blind, placebo-controlled trial, participants presenting with an acute myocardial infarction were randomly assigned 1:1 to 6 months of high-dose omega-3 fatty acids (n=180) or placebo (n=178). Cardiac magnetic resonance imaging was used to assess cardiac structure and tissue characteristics at baseline and after study therapy. The primary study endpoint was change in left ventricular systolic volume index. Secondary endpoints included change in noninfarct myocardial fibrosis, left ventricular ejection fraction, and infarct size. RESULTS: By intention-to-treat analysis, patients randomly assigned to omega-3 fatty acids experienced a significant reduction of left ventricular systolic volume index (-5.8%, P=0.017), and noninfarct myocardial fibrosis (-5.6%, P=0.026) in comparison with placebo. Per-protocol analysis revealed that those patients who achieved the highest quartile increase in red blood cell omega-3 index experienced a 13% reduction in left ventricular systolic volume index in comparison with the lowest quartile. In addition, patients in the omega-3 fatty acid arm underwent significant reductions in serum biomarkers of systemic and vascular inflammation and myocardial fibrosis. There were no adverse events associated with high-dose omega-3 fatty acid therapy. CONCLUSIONS: Treatment of patients with acute myocardial infarction with high-dose omega-3 fatty acids was associated with reduction of adverse left ventricular remodeling, noninfarct myocardial fibrosis, and serum biomarkers of systemic inflammation beyond current guideline-based standard of care. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT00729430.

Case records of the Massachusetts General Hospital. Case 35-2014: a 31-year-old woman with fevers, chest pain, and a history of HCV infection and substance-use disorder.

A 31-year-old woman with substance-use disorder was admitted to this hospital because of fevers and chest pain. CT of the chest revealed multiple thick-walled nodular opacities throughout both lungs. Diagnostic tests were performed, and management decisions were made.

Real-time fusion of coronary CT angiography with x-ray fluoroscopy during chronic total occlusion PCI.

OBJECTIVES: The purpose of this study was to demonstrate the feasibility of real-time fusion of coronary computed tomography angiography (CTA) centreline and arterial wall calcification with x-ray fluoroscopy during chronic total occlusion (CTO) percutaneous coronary intervention (PCI). METHODS: Patients undergoing CTO PCI were prospectively enrolled. Pre-procedural CT scans were integrated with conventional coronary fluoroscopy using prototype software. We enrolled 24 patients who underwent CTO PCI using the prototype CT fusion software, and 24 consecutive CTO PCI patients without CT guidance served as a control group. RESULTS: Mean age was 66 ± 11 years, and 43/48 patients were men. Real-time CTA fusion during CTO PCI provided additional information regarding coronary arterial calcification and tortuosity that generated new insights into antegrade wiring, antegrade dissection/reentry, and retrograde wiring during CTO PCI. Overall CTO success rates and procedural outcomes remained similar between the two groups, despite a trend toward higher complexity in the fusion CTA group. CONCLUSIONS: This study demonstrates that real-time automated co-registration of coronary CTA centreline and calcification onto live fluoroscopic images is feasible and provides new insights into CTO PCI, and in particular, antegrade dissection reentry-based CTO PCI. KEY POINTS: • Real-time semi-automated fusion of CTA/fluoroscopy is feasible during CTO PCI. • CTA fusion data can be toggled on/off as desired during CTO PCI • Real-time CT calcium and centreline overlay could benefit antegrade dissection/reentry-based CTO PCI.

Clinical implementation of an emergency department coronary computed tomographic angiography protocol for triage of patients with suspected acute coronary syndrome.

OBJECTIVES: To evaluate the efficiency and safety of emergency department (ED) coronary computed tomography angiography (CTA) during a 3-year clinical experience. METHODS: Single-center registry of coronary CTA in consecutive ED patients with suspicion of acute coronary syndrome (ACS). The primary outcome was efficiency of coronary CTA defined as the length of hospitalization. Secondary endpoints of safety were defined as the rate of downstream testing, normalcy rates of invasive coronary angiography (ICA), absence of missed ACS, and major adverse cardiac events (MACE) during follow-up, and index radiation exposure. RESULTS: One thousand twenty two consecutive patients were referred for clinical coronary CTA with suspicion of ACS. Overall, median time to discharge home was 10.5 (5.7-24.1) hours. Patient disposition was 42.7 % direct discharge from the ED, 43.2 % discharge from emergency unit, and 14.1 % hospital admission. ACS rate during index hospitalization was 9.1 %. One hundred ninety two patients underwent additional diagnostic imaging and 77 underwent ICA. The positive predictive value of CTA compared to ICA was 78.9 % (95 %-CI 68.1-87.5 %). Median CT radiation exposure was 4.0 (2.5-5.8) mSv. No ACS was missed; MACE at follow-up after negative CTA was 0.2 %. CONCLUSIONS: Coronary CTA in an experienced tertiary care setting allows for efficient and safe management of patients with suspicion for ACS. KEY POINTS: • ED Coronary CTA using advanced systems is associated with low radiation exposure. • Negative coronary CTA is associated with low rates of MACE. • CTA in ED patients enables short median time to discharge home. • CTA strategy is characterized by few downstream tests including unnecessary ICA.

Dehiscence of a pulmonary bioprosthesis with a focal dissection of the pulmonary artery in a patient with congenital pulmonic stenosis.

Pulmonary valve replacement (PVR) is the most common adult congenital cardiac operation performed. Valve degeneration leading to prosthetic stenosis and/or regurgitation is a long-term risk in this population and may be associated with paravalvular leak (PVL). Complications involving the proximal pulmonary artery, including dissection, are less clearly defined. Herein, we report the case of a 30-year-old patient with a history of multiple pulmonary valve interventions secondary to congenital pulmonic stenosis, who developed dehiscence of a bioprosthetic PVR associated with significant paravalvular leak (PVL) and further complicated by a focal dissection of the proximal pulmonary artery.

Non-diagnostic coronary artery calcification and stenosis: a correlation of coronary computed tomography angiography and invasive coronary angiography.

Background Heavy coronary artery calcification (CAC) impairs diagnostic accuracy of coronary computed tomography angiography (cCTA) and is considered to be a major limitation. Purpose To investigate the effect of non-evaluable CAC seen on cCTA on clinical decision-making by determining the degree of subsequent invasive testing and to assess the relationship between non-evaluable segments containing CAC and significant stenosis as seen in invasive coronary angiography (ICA). Material and Methods The study comprised of 356 patients who underwent cCTA and subsequent ICA within 2 months between 2005 and 2009. Clinical reports were reviewed to identify the indications for referral to ICA. In a subset of 68 patients where non-diagnostic CAC on cCTA and significant stenosis on ICA were present in the same segment, we correlated and analyzed the underlying stenosis severity of the lesion on ICA to the cCTA. Lesions with CAC were analyzed in a standardized fashion by application of reading rules. Results Non-diagnostic CAC on cCTA prompted ICA in 5.6% of patients. CAC occurred at the site of maximum stenosis in segments with stenosis <50% (95.9% [47/49]), 50-69% (82.4% [28/34]), 70-99% (64.5% [31/48]), and 100% (33.3% [1/3]). At the point of maximum calcium deposit, non-obstructive disease was present in 61.2%. Application of reading rules resulted in a 44% reduction in non-diagnostic cCTA reads. Conclusion Severe CAC may prompt further investigation with ICA. There is less CAC with increasing lesion severity at the point of maximum stenosis. Additional application of reading rules improved non-diagnostic cCTA reads.

Medical Registry Data Collection Efficiency: A Crossover Study Comparing Web-Based Electronic Data Capture and a Standard Spreadsheet.

BACKGROUND: Electronic medical records and electronic data capture (EDC) have changed data collection in clinical and translational research. However, spreadsheet programs, such as Microsoft Excel, are still used as data repository to record and organize patient data for research. OBJECTIVE: The objective of this study is to assess the efficiency of EDC as against a standard spreadsheet in regards to time to collect data and data accuracy, measured in number of errors after adjudication. METHODS: This was a crossover study comparing the time to collect data in minutes between EDC and a spreadsheet. The EDC tool used was Research Electronic Data Capture (REDCap), whereas the spreadsheet was Microsoft Excel. The data collected was part of a registry of patients who underwent coronary computed tomography angiography in the emergency setting. Two data collectors with the same experience went over the same patients and collected relevant data on a case report form identical to the one used in our Emergency Department (ED) registry. Data collection tool was switched after the patient that represented half the cohort. For this, the patient cohort was exactly 30 days of our ED coronary Computed Tomography Angiography registry and the point of crossover was determined beforehand to be 15 days. We measured the number of patients admitted, and time to collect data. Accuracy was defined as absence of blank fields and errors, and was assessed by comparing data between data collectors and counting every time the data differed. Statistical analysis was made using paired t -test. RESULTS: The study included 61 patients (122 observations) and 55 variables. The crossover occurred after the 30th patient. Mean time to collect data using EDC in minutes was 6.2±2.3, whereas using Excel was 8.0±2.0 (P <.001), a difference of 1.8 minutes between both means (22%). The cohort was evenly distributed with 3 admissions in the first half of the crossover and 4 in the second half. We saw 2 (<0.1%) continuous variable typos in the spreadsheet that a single data collector made. There were no blank fields. The data collection tools showed no differences in accuracy of data on comparison. CONCLUSIONS: Data collection for our registry with an EDC tool was faster than using a spreadsheet, which in turn allowed more efficient follow-up of cases.

Cost-effectiveness of follow-up of pulmonary nodules incidentally detected on cardiac computed tomographic angiography in patients with suspected coronary artery disease.

BACKGROUND: Pulmonary nodules (PNs) are often detected incidentally during coronary computed tomographic (CT) angiography, which is increasingly being used to evaluate patients with chest pain symptoms. However, the efficiency of following up on incidentally detected PN is unknown. METHODS AND RESULTS: We determined demographic and clinical characteristics of stable symptomatic patients referred for coronary CT angiography in whom incidentally detected PNs warranted follow-up. A validated lung cancer simulation model was populated with data from these patients, and clinical and economic consequences of follow-up per Fleischner guidelines versus no follow-up were simulated. Of the 3665 patients referred for coronary CT angiography, 591 (16%) had PNs requiring follow-up. The mean age of patients with PNs was 59±10 years; 66% were male; 67% had ever smoked; and 21% had obstructive coronary artery disease. The projected overall lung cancer incidence was 5.8% in these patients, but the majority died of coronary artery disease (38%) and other causes (57%). Follow-up of PNs was associated with a 4.6% relative reduction in cumulative lung cancer mortality (absolute mortality: follow-up, 4.33% versus non-follow-up, 4.54%), more downstream testing (follow-up, 2.34 CTs per patient versus non-follow-up, 1.01 CTs per patient), and an average increase in quality-adjusted life of 7 days. Costs per quality-adjusted life-year gained were $154 700 to follow up the entire cohort and $129 800 per quality-adjusted life-year when only smokers were included. CONCLUSIONS: Follow-up of PNs incidentally detected in patients undergoing coronary CT angiography for chest pain evaluation is associated with a small reduction in lung cancer mortality. However, significant downstream testing contributes to limited efficiency, as demonstrated by a high cost per quality-adjusted life-year, especially in nonsmokers.

High-risk coronary plaque at coronary CT angiography is associated with nonalcoholic fatty liver disease, independent of coronary plaque and stenosis burden: results from the ROMICAT II trial.

PURPOSE: To determine the association between nonalcoholic fatty liver disease (NAFLD) and the presence of high-risk coronary atherosclerotic plaque as assessed with coronary computed tomographic (CT) angiography. MATERIALS AND METHODS: This study was approved by the local ethics committees; informed consent was obtained. Patients randomized to the coronary CT angiography arm of the Rule Out Myocardial Infarction using Computer Assisted Tomography, or ROMICAT, II trial who underwent both nonenhanced CT to assess calcium score and contrast material-enhanced coronary CT angiography were included. Readers assessed coronary CT angiography images for the presence of coronary plaque, significant stenosis (≥50%), and high-risk plaque features (positive remodeling, CT attenuation < 30 HU, napkin-ring sign, spotty calcium). NAFLD was defined as hepatic steatosis at nonenhanced CT (liver minus spleen CT attenuation < 1 HU) without evidence of clinical liver disease, liver cirrhosis, or alcohol abuse. To determine the association between high-risk plaque and NAFLD, univariable and multivariable logistic regression analyses were performed, with high-risk plaque as a dependent variable and NAFLD, traditional risk factors, and extent of coronary atherosclerosis as independent variables. RESULTS: Overall, 182 (40.9%) of 445 patients had CT evidence of NAFLD. High-risk plaque was more frequent in patients with NAFLD than in patients without NAFLD (59.3% vs 19.0%, respectively; P < .001). The association between NAFLD and high-risk plaque (odds ratio, 2.13; 95% confidence interval: 1.18, 3.85) persisted after adjusting for the extent and severity of coronary atherosclerosis and traditional risk factors. CONCLUSION: NAFLD is associated with advanced high-risk coronary plaque, independent of traditional cardiovascular risk factors and the extent and severity of coronary artery disease.

Effect of the 2010 task force criteria on reclassification of cardiovascular magnetic resonance criteria for arrhythmogenic right ventricular cardiomyopathy.

BACKGROUND: We sought to evaluate the effect of application of the revised 2010 Task Force Criteria (TFC) on the prevalence of major and minor Cardiovascular Magnetic Resonance (CMR) criteria for Arrhythmogenic Right Ventricular Cardiomyopathy (ARVC) versus application of the original 1994 TFC. We also assessed the utility of MRI to identify alternative diagnoses for patients referred for ARVC evaluation. METHODS: 968 consecutive patients referred to our institution for CMR with clinical suspicion of ARVC from 1995 to 2010, were evaluated for the presence of major and minor CMR criteria per the 1994 and 2010 ARVC TFC. CMR criteria included right ventricle (RV) dilatation, reduced RV ejection fraction, RV aneurysm, or regional RV wall motion abnormalities. When quantitative measures of RV size and function were not available, and in whom abnormal size or function was reported, a repeat quantitative analysis by 2 qualified CMR physicians in consensus. RESULTS: Of 968 patients, 220 (22.7%) fulfilled either a major or a minor 1994 TFC, and 25 (2.6%) fulfilled any of the 2010 TFC criterion. Among patients meeting any 1994 criteria, only 25 (11.4%) met at least one 2010 criterion. All patients who fulfilled a 2010 criteria also satisfied at least one 1994 criterion. Per the 2010 TFC, 21 (2.2%) patients met major criteria and 4 (0.4%) patients fulfilled at least one minor criterion. Eight patients meeting 1994 minor criteria were reclassified as satisfying 2010 major criteria, while 4 patients fulfilling 1994 major criteria were reclassified to only minor or no criteria under the 2010 TFC.Eighty-nine (9.2%) patients had alternative cardiac diagnoses, including 43 (4.4%) with clinically significant potential ARVC mimics. These included cardiac sarcoidosis, RV volume overload conditions, and other cardiomyopathies. CONCLUSIONS: Application of the 2010 TFC resulted in reduction of total patients meeting any diagnostic CMR criteria for ARVC from 22.7% to 2.6% versus the 1994 TFC. CMR identified alternative cardiac diagnoses in 9.2% of patients, and 4.4% of the diagnoses were potential mimics of ARVC.

New and evolving concepts in CT for abdominal vascular imaging.

Computed tomographic (CT) angiography has become the standard of care, supplanting invasive angiography for comprehensive initial evaluation of acute and chronic conditions affecting the vascular system in the abdomen and elsewhere. Over the past decade, the capabilities of CT have improved substantially; simultaneously, the expectations of the referring physician and vascular surgeons have also evolved. Increasingly, CT angiography is used as an imaging biomarker for treatment selection and assessment of effectiveness. However, the growing use of CT angiography has also introduced some challenges, as potential radiation-associated and contrast media-induced risks need to be addressed. These concerns can be partly confronted by modifying scanning parameters (applying a low tube voltage) with or without using software-based solutions. Most recently, multienergy technology has endowed CT with new capabilities offering improved CT angiographic image quality and novel plaque characterization while decreasing radiation and iodine dose. In this article, we discuss current and new approaches using both conventional and multienergy CT for studying vascular disease in the abdomen. We propose various approaches to overcoming commonly encountered image quality challenges in CT angiography. In addition, we describe supplemental strategies for improving patient safety that leverage the available technology.

Ultra-low contrast computed tomographic angiography (CTA) with 20-mL total dose for transcatheter aortic valve implantation (TAVI) planning.

Transcatheter aortic valve implantation workup includes assessment of the aorta and the iliofemoral arteries by computed tomographic angiography. An important group of transcatheter aortic valve implantation candidates have severe renal failure. We tested a novel computed tomographic angiography protocol (128-detector-row dual-source scanner, high-pitch helical mode) with ultralow contrast volume (20 mL) in 8 patients, compared with 8 controls. Contrast-to-noise ratio and subjective image quality, albeit lower than in the controls, were suitable for interpretation in the ultralow contrast volume group throughout all measured locations.

Coronary computed tomography angiography at 140 kV versus 120 kV: assessment of image quality and radiation exposure in overweight and moderately obese patients.

BACKGROUND: Although a tube potential of 140 kV is available on most computed tomography (CT) scanners, its incremental diagnostic value versus 120 kV has been controversial. PURPOSE: To retrospectively evaluate the image quality and radiation exposure of cardiac computed tomography angiography (CCTA) performed at 140 kV in comparison to CCTA at 120 kV in overweight and moderately obese patients. MATERIAL AND METHODS: Eighty-eight patients who were referred for CCTA between January 2010 and May 2012 were included. Forty-four patients who were overweight or moderately obese (body mass index [BMI], 25-35 kg/m(2)) underwent CCTA with dual-source CT (DSCT) scanner at 140 kV. Forty-four match controls who underwent CCTA with DSCT at 120 kV were identified per BMI, average heart rate, scan indication, and scan acquisition mode. All scans were performed per routine protocols with direct physician supervision. Quantitative image metrics (CT attenuation, image noise, contrast-to-noise ratio [CNR], and signal-to-noise ratio [SNR] of left main [LM] and proximal right coronary artery [RCA]) were assessed. Effective radiation dose was compared between the two groups. RESULTS: Overall, all scans were diagnostic without any non-evaluable coronary segment per clinical report. 140 kV had a lower attenuation and image noise versus 120 kV (P<0.01). Both SNR and CNR of proximal coronary arteries were similar between 140 kV and 120 kV (SNR, LM P=0.93, RCA P=0.62; CNR, LM P=0.57, RCA P=0.77). 140 kV was associated with a 35.3% increase in effective radiation dose as compared with 120 kV (5.1 [3.6-8.2] vs. 3.3 [2.0-5.1] mSv, respectively; P<0.01). CONCLUSION: 140 kV CCTA resulted in similar image quality but a higher effective radiation dose in comparison to 120 kV CCTA. Therefore, in overweight and moderately obese patients, a tube potential of 120 kV may be sufficient for CCTA with diagnostic image quality.

Radiation dose reduction in pediatric cardiac computed tomography: experience from a tertiary medical center.

Cardiac CT angiography (cCTA) has become an established method for the assessment of congenital heart disease. However, the potential harmful effects of ionizing radiation must be considered, particularly in younger, more radiosensitive patients. In this study, we sought to assess the temporal change in radiation doses from pediatric cCTA during an 8-year period at a tertiary medical center. This retrospective study included all patients ≤18 years old who were referred to electrocardiography (ECG)-gated cCTA for the assessment of congenital heart disease or inflammatory disease (Kawasaki disease) from November 2004 to September 2012. During the study period, 95 patients were scanned using 3 different scanner models-64-slice multidetector CT (64-MDCT) and first- (64-DSCT) and second-generation (128-DSCT) dual-source CT-and 3 scan protocols-retrospective ECG-gated helical scanning (RG), prospective ECG-triggered axial scanning (PT), or prospective ECG-triggered high-pitch helical scanning (HPH). Effective dose (ED) was calculated with the dose length product method with a conversion factor (k) adjusted for age. ED was then compared among scan protocols. Image quality was extracted from clinical cCTA reports when available. Overall, 94 % of scans were diagnostic (80 % for 64-slice MDCT, 93 % for 64-slice DSCT, and 97 % for 128-slice DSCT).With 128-DSCT, median ED (1.0 [range 0.6-2.0] mSv) decreased by 85.8 % and 66.8 % compared with 64-MDCT (6.8 [range 2.9-13.6] mSv) and 64-DSCT (2.9 [range 0.9-4.1] mSv), respectively. With HPH, median ED (0.9 [range 0.6-1.8] mSv) decreased by 59.4 % and 85.4 % compared with PT (2.2 [range 0.9-3.4] mSv) and RG (6.1 [range 2.5-10.6] mSv). cCTA can now be obtained at very low radiation doses in pediatric patients using the latest dual-source CT technology in combination with prospective ECG-triggered HPH acquisition.