Impact of severe left ventricular outflow tract calcification on device failure and short-term mortality in patients undergoing TAVI.

BACKGROUND: To investigate the impact of left ventricular outflow tract (LVOT) calcification on the incidence of device failure and mortality in patients undergoing transcatheter aortic valve implantation (TAVI). METHODS: Of 690 consecutive patients undergoing transfemoral TAVI in our center from January 2013 to December 2015, 600 presented with non-severe (NSCALVOT) and 90 (13.0%) with severe (SCALVOT) LVOT calcification. Primary outcome of interest was device failure defined as a composite of procedural death, prosthesis dislocation, annulus rupture or significant para-valvular leakage (PVL). Secondary outcome of interest was 30-day and one-year all-cause mortality. RESULTS: Mean age of the population was 80.8 ±â€¯7.2 years, mean STS score was 5.7 ±â€¯4.6% and 50.6% of the patients were women. Patients with SCALVOT more frequently experienced device failure (10.0% vs. 3.8%, p = 0.009) and were at higher risk of 30 day (10.0% vs. 2.8%, p < 0.001) all cause mortality as compared to those with NSCALVOT. Furthermore, patients with SCALVOT were more frequently in need of post-dilation (15.6% vs. 8.5%, p = 0.032) and showed higher incidence of significant PVL (7.8% vs. 2.5%, p = 0.007). In multivariate analysis, SCALVOT (hazard ratio 2.87; 95% CI 1.20 to 6.34) and use of balloon-expandable prosthesis (hazard ratio 0.32; 95% CI 0.15 to 0.73) were identified as independent predictors of device failure. CONCLUSION: Presence of severe LVOT calcification in patients undergoing transfemoral TAVI is associated with a higher risk of device failure and short-term mortality.

Myocardial ischemia detection with single-phase CT perfusion in symptomatic patients using high-pitch helical image acquisition technique.

Coronary CT angiography (CCTA) suffers from a reduced diagnostic accuracy in patients with heavily calcified coronary arteries or prior myocardial revascularisation due to artefacts caused by calcifications and stent material. CT myocardial perfusion imaging (CTMPI) yields high potential for the detection of myocardial ischemia and might help to overcome the above mentioned limitations. We analysed CT single-phase perfusion using high-pitch helical image acquisition technique in patients with prior myocardial revascularisation. Thirty-six patients with an indication for invasive coronary angiography (28 with coronary stents, 2 with coronary artery bypass grafts and 6 with both) were included in this prospective study at two study sites. All patients were examined on a 2nd generation dual-source CT system. Stress CT images were obtained using a prospectively ECG-triggered single-phase high-pitch helical image acquisition technique. During stress the tracer for myocardial perfusion (MP) SPECT imaging was administered. Rest CT images were acquired using prospectively ECG-triggered sequential CT. MP-SPECT imaging and invasive coronary angiography served as standard of reference. In this heavily diseased patient cohort CCTA alone showed a low overall diagnostic accuracy for detection of hemodynamically relevant coronary artery stenosis of only 31% on a per-patient base and 60% on a per-vessel base. Combining CCTA and CTMPI allowed for a significantly higher overall diagnostic accuracy of 78% on a per-patient base and 92% on a per-vessel base (p < 0.001). Mean radiation dose for stress CT scans was 0.9 mSv, mean radiation dose for rest CT scans was 5.0 mSv. In symptomatic patients with known coronary artery disease and prior myocardial revascularization combining CCTA and CTMPI showed significantly higher diagnostic accuracy in detection of hemodynamically significant coronary artery stenosis when compared to CCTA alone.

Bivalirudin vs Heparin in Patients Who Undergo Transcatheter Aortic Valve Implantation.

BACKGROUND: We aimed to compare safety and efficacy of the direct thrombin inhibitor bivalirudin with unfractionated heparin (UFH) during transcatheter aortic valve implantation (TAVI). METHODS: In this retrospective analysis, 461 patients underwent TAVI between 2007 and 2012; 339 patients received bivalirudin, and 122 patients received UFH. In the bivalirudin group, the Sapien XT valve was implanted in 159 (46.9%) patients, and 180 (53.1%) received a Medtronic CoreValve. In the UFH group, only the Medtronic CoreValve was implanted. The primary outcome of interest was the incidence of any bleeding. Secondary outcomes of interest were all-cause mortality and cardiovascular mortality at 72 hours after the procedure and at 30 days. RESULTS: No significant difference between the groups was observed for life-threatening bleeding (2.4% for bivalirudin vs 3.3% for UFH; P = 0.59), major bleeding (8.3% vs 8.2%, respectively; P = 0.98) and minor bleeding (8.3% vs 7.4%, respectively; P = 0.76). At 72 hours after the procedure, all-cause mortality was 3.0% in the bivalirudin group and 3.3% for the UFH group (P = 0.88), whereas cardiovascular mortality was 3.0% in the bivalirudin group and 2.5% in the heparin group (P = 0.77). At 30 days, all-cause mortality was 5.3% vs 4.1% in the bivalirudin and heparin groups (P = 0.57) and cardiovascular mortality was 4.4% vs 2.5% (P = 0.33). Device success (Valve Academic Research Consortium 2 composite end point) was 94.0% in the bivalirudin-treated and 92.6% in the UFH-treated patients (P = 0.60). The early safety at 30 days was 85.3% in the bivalirudin-treated group compared with 83.6% in the UFH-treated group (P = 0.65). CONCLUSIONS: Bivalirudin has a safety and efficacy profile similar to weight-adjusted UFH during the TAVI procedure.

Prospective Randomized Trial on Radiation Dose Estimates of CT Angiography Applying Iterative Image Reconstruction: The PROTECTION V Study.

OBJECTIVES: The purpose of this study was to assess the potential of iterative image reconstruction (IR) of images for radiation dose reduction in coronary computed tomography angiography (CTA). Therefore, IR in combination with 30% tube current reduction was compared with standard scanning with filtered back projection (FBP) reconstruction. BACKGROUND: Lately, new IR techniques with advanced raw data processing have been introduced by different computed tomography vendors, thus allowing for either image noise reduction at unchanged radiation dose levels or radiation dose reductions at comparable image noise levels. METHODS: In this prospective, multicenter, multivendor noninferiority trial, we randomized 400 consecutive patients to 1 of 2 groups: a control group using standard FBP image reconstruction and standard tube current or an interventional group using IR technique and 30% tube current reduction. The primary endpoint was to demonstrate noninferiority in image quality (IQ) in the IR group. IQ was assessed on a 4-point scale (1, nondiagnostic IQ; 4, excellent IQ). Secondary endpoints included total radiation dose estimates and the rate of downstream testing during 30-day follow-up. RESULTS: Median IQ in the IR group was noninferior compared with the conventional FBP group (IR, 3.5 [interquartile range: 3.0 to 4.0]; FBP, 3.4 [interquartile range: 2.8 to 4.0], p for noninferiority <0.016). The radiation exposure was significantly lower in the IR group (median dose-length-product 157 [interquartile range: 114 to 239] mGy·cm vs. 222 [interquartile range: 141 to 319] mGy·cm for IR vs. FBP, respectively, p < 0.0001). The rate of downstream testing did not differ significantly (7.7% vs. 7.9% for IR vs. FBP, respectively, p = 0.94). CONCLUSIONS: Coronary CTA image quality is maintained with the combined use of a 30% reduced tube current and IR algorithms when compared with conventional FBP image reconstruction techniques and standard tube current. (Prospective Randomized Trial On RadiaTion Dose Estimates Of CT AngIOgraphy In PatieNts: NCT01453712).

Evaluation of A New Bolus Tracking-Based Algorithm for Predicting A Patient-Specific Time of Arterial Peak Enhancement in Computed Tomography Angiography.

OBJECTIVES: The aim of this study was to evaluate the systematic and random errors of a new bolus tracking-based algorithm that predicts a patient-specific time of peak arterial enhancement and compare its performance with a best-case scenario for the current bolus tracking technique. MATERIALS AND METHODS: All local institutional review boards approved this retrospective study, in which the test bolus signals of cardiac computed tomography angiographies of 72 patients (46 men; median age, 62 years [range, 31-81 years]) were used to simulate contrast enhancement curves for a multitude of injection protocols with iodine delivery rates (IDRs) varying between 0.5 and 2.5 gI/s, injection durations between 4 and 30 seconds, and tube voltages of 100 and 120 kV. From these simulated curves, bolus tracking signals with statistical errors of 4 Hounsfield units (HU) (standard deviation) were derived with trigger values of 100 and 150 HU at 100 and 120 kV, respectively. The new algorithm then matched the actual bolus tracking signal with a database of expected enhancement curves for that particular injection protocol, taking into account population-averaged blood circulation characteristics with variations in patient weight and cardiac output. Posttrigger delays (PTDs) were calculated as the time difference between the last bolus tracking point and the time of peak enhancement. The systematic and random errors between the predicted and true PTDs were assessed and compared with a best-case scenario for the current bolus tracking method. RESULTS: With the current bolus tracking technique, interpatient variations decrease with higher IDRs and earlier triggering (lower tube voltage and/or lower trigger value), and the true PTDs increase linearly with injection duration. Compared with the current bolus tracking method, the systematic and random errors of the algorithm-predicted PTDs are smaller, do not depend on the IDR, and are predictable over a large range of total iodine doses. The median difference between the true and algorithm-predicted PTD is less than ±1 second for all IDRs and injection durations, and the algorithm was able to predict patient-specific PTDs within ±2 seconds from the true PTD in more than 90% of patients for almost all injection protocols. CONCLUSIONS: The new algorithm can robustly predict a patient-specific time of arterial peak enhancement and is better than a best-case scenario for the current bolus tracking technique because interpatient variations are taken into account. It offers a new framework for scan timing optimization and can potentially be used for personalized scan timing in real time.

Dynamic myocardial CT perfusion imaging for evaluation of myocardial ischemia as determined by MR imaging.

OBJECTIVES: The aim of this study was to determine the feasibility of computed tomography (CT)-based dynamic myocardial perfusion imaging for the assessment of myocardial ischemia and infarction compared with cardiac magnetic resonance (CMR). BACKGROUND: Sequential myocardial CT perfusion imaging has emerged as a novel imaging technique for the assessment of myocardial hypoperfusion. METHODS: We prospectively enrolled subjects with known coronary artery disease who underwent adenosine-mediated stress dynamic dual-source CT (100 kV, 320 mAs/rot) and CMR (3-T). Estimated myocardial blood flow (eMBF) and estimated myocardial blood volume (eMBV) were derived from CT images, using a model-based parametric deconvolution technique. The values were independently related to perfusion defects (ischemic and/or infarcted myocardial segments) as visually assessed during rest/stress and late gadolinium enhancement CMR. Conventional measures of diagnostic accuracy and differences in eMBF/eMBV were determined. RESULTS: Of 38 enrolled subjects, 31 (mean age 70.4 ± 9.3 years; 77% men) completed both CT and CMR protocols. The prevalence of ischemic and infarcted myocardial segments detected by CMR was moderate (11.6%, n = 56 and 12.6%, n = 61, respectively, of 484 analyzed segments, with 8.4% being transmural). The diagnostic accuracy of CT for the detection of any perfusion defect was good (eMBF threshold, 88 ml/mg/min; sensitivity, 77.8% [95% confidence interval (CI): 69% to 85%]; negative predictive value, 91.3% [95% CI: 86% to 94%]) with moderate positive predictive value (50.6% [95% CI: 43% to 58%] and specificity (75.41% [95% CI: 70% to 79%]). Higher diagnostic accuracy was observed for transmural perfusion defects (sensitivity 87.8%; 95% CI: 74% to 96%) and infarcted segments (sensitivity 85.3%; 95% CI: 74% to 93%). Although eMBF in high-quality examinations was lower but not different between ischemic and infarcted segments (72.3 ± 18.7 ml/100 ml/min vs. 73.1 ± 31.9 ml/100 ml/min, respectively, p > 0.05), eMBV was significantly lower in infarcted segments compared with ischemic segments (11.3 ± 3.3 ml/100 ml vs. 18.4 ± 2.8 ml/100 ml, respectively; p < 0.01). CONCLUSIONS: Compared with CMR, dynamic stress CT provides good diagnostic accuracy for the detection of myocardial perfusion defects and may differentiate ischemic and infarcted myocardium.

High-pitch coronary CT angiography in dual-source CT during free breathing vs. breath holding in patients with low heart rates.

BACKGROUND: Coronary CT angiography (CCTA) is usually performed during breath holding to reduce motion artifacts caused by respiration. However, some patients are not able to follow the breathing commands adequately due to deafness, hearing impairment, agitation or pulmonary diseases. The aim of this study was to evaluate the potential of high-pitch CCTA in free breathing patients when compared to breath holding patients. METHODS: In this study we evaluated 40 patients (20 free breathing and 20 breath holding patients) with a heart rate of 60 bpm or below referred for CCTA who were examined on a 2nd generation dual-source CT system. Image quality of each coronary artery segment was rated using a 4-point grading scale (1: non diagnostic-4: excellent). RESULTS: Mean heart rate during image acquisition was 52 ± 5 bpm in both groups. There was no significant difference in mean image quality, slightly favoring image acquisition during breath holding (mean image quality score 3.76 ± 0.32 in breath holding patients vs. 3.61 ± 0.45 in free breathing patients; p = 0.411). Due to a smaller amount of injected contrast medium, there was a trend for signal intensity to be slightly lower in free breathing patients, but this was not statistically significant (435 ± 123 HU vs. 473 ± 117 HU; p=0.648). CONCLUSION: In patients with a low heart rate who are not able to hold their breath adequately, CCTA can also be acquired during free breathing without substantial loss of image quality when using a high pitch scan mode in 2nd generation dual-source CT.

Novel single-source high-pitch protocol for CT angiography of the aorta: comparison to high-pitch dual-source protocol in the context of TAVI planning.

Purpose Computed tomography (CT) is increasingly being used for planning purposes prior to trans-arterial valve implantation (TAVI). High-pitch protocols using a 2nd generation dual-source CT (DSCT) allow for a comprehensive assessment of the aortic valve anulus, its distance to the coronary artery ostia, the aortic bulbus and the iliofemoral arteries with very low radiation exposure and low amount of contrast agent. The aim of this study was to evaluate the image quality of a comparable high-pitch scan mode in a modern single-source CT (SSCT) system. Methods 40 patients with severe symptomatic aortic valve stenosis have been examined for planning purposes prior to TAVI. The first 20 consecutive patients were examined with a 2nd generation DSCT system using a high-pitch scan mode (pitch value 3.4) and 60 ml of contrast agent. The second group of 20 consecutive patients were examined with a 128-slice SSCT system, using a high-pitch scan mode (pitch value of 1.7) and 60 ml of contrast agent. Image quality of the aortic valve, the ascending aorta, the coronary artery ostia, the iliofemoral arteries and overall image quality were graded in a blinded fashion using a 4-point-grading-scale. Furthermore, signal intensity and image noise were derived in the ascending aorta and in the ilio-femoral arteries. Results There was a minor but significant difference in the overall image quality score with lower image quality in SSCT (3.5 ± 0.6) when compared to DSCT (3.85 ± 0.4; p = 0.037). The mean image quality score was significantly higher in patients examined in DSCT when compared to SSCT regarding the evaluability of the coronary ostia (4.0 vs. 3.5; p < 0.01) and the image quality of the ascending aorta (4.0 vs. 3.5; p < 0.01). There was no significant difference in evaluation of the aortic valve and its anulus (3.85 for DSCT and 3.65 for SSCT; p = 0.149) and image quality of the iliofemoral arteries (3.65 for DSCT and 3.85 for SSCT; p = 0.140). Signal intensity and image noise did not differ significantly between both groups. Conclusions This study presents a novel high-pitch protocol for modern SSCT scanners, which allows CT angiography for TAVI planning with a similar radiation dose and contrast agent exposition and only small compromises in image quality compared to a high-pitch protocol on a DSCT scanner.

Optimal timing for first-pass stress CT myocardial perfusion imaging.

CT-based myocardial perfusion imaging (CTP) has been shown to accurately detect myocardial perfusion defects when compared to SPECT. When performing single-phase first-pass stress CTP, timing is of major importance. The aim of this study was to provide guidance for optimal timing of single-phase first-pass stress CTP acquisitions. 16 patients (12 male, age, 69 ± 8 years) with known or suspected coronary artery disease underwent invasive coronary angiography with fractional flow reserve (FFR) measurements using a pressure wire as well as a time-resolved CTP protocol under adenosine stress, performed on a dual-Source CT scanner over a period of 30 s. From the CTP data, time-attenuation curves have been determined both in known ischemic myocardium with a corresponding coronary artery stenosis as proven by a FFR below 0.75 in invasive coronary angiography, as well as in non-ischemic reference myocardium during pharmacological stress. Furthermore, contrast enhancement in the ascending aorta was determined. The time point for an optimal contrast (i.e., difference in Hounsfield Units, HU) between ischemic and normal myocardium was determined. Under pharmacological stress using adenosine, a maximum mean HU difference between ischemic and non-ischemic myocardium (17.7-22.5 HU) was observed 24-32 s after injection of contrast medium. The maximal attenuation difference between normal and ischemic myocardium ranged from 15 to 77 HU in the analyzed patient cohort. When applying a bolus-tracking technique with an automatic contrast detection in the proximal ascending aorta, the optimal time frame for stress CTP was between 8 and 16 s after contrast enhancement in the aorta exceeds 100 HU, or between 7 and 15 s using a threshold of 150 HU. For first-pass CT myocardial perfusion imaging there is a time frame of approximately 8 s for optimal differentiation of ischemic and non-ischemic myocardium, which will be helpful to optimize single-phase CTP scans.

Metal artifact reduction by dual-energy computed tomography using energetic extrapolation: a systematically optimized protocol.

OBJECTIVES: Energetic extrapolation is a promising strategy to reduce metal artifacts in dual-source computed tomography (DSCT). We performed this study to systematically optimize image acquisition parameters for this approach in a hip phantom and assess its value in a clinical study. MATERIALS AND METHODS: Titanium and steel hip prostheses were placed in a standard hip phantom and a water tank and scanned on a DSCT scanner. Tube spectra, tube current ratio, collimation, pitch, and rotation time were optimized in a stepwise process. Artifacts were quantified by measuring the standard deviation of the computed tomography density in a doughnut-shaped region of interest placed around the prosthesis. A total of 22 adult individuals with metallic implants referred for computed tomography for a musculoskeletal indication were scanned using the optimized protocol. Degree of artifacts and diagnostic image quality were rated visually (0-10) and maximum streak intensity was measured. RESULTS: Sn140/100 kVp proved superior to Sn140/80 kVp. There was a benefit for increasing tube current ratio from 1:1 to 3:1, but not beyond, in favor of the Sn140 kVp spectrum. Artifacts were less severe for a collimation of 32 × 0.6 mm as compared with 40 × 0.6 mm. A pitch of 0.5 at a rotation time of 0.5 seconds per rotation was preferable to other combinations with comparable scanning times. In the clinical study, increasing the extrapolated photon energy from 64 to 120 keV decreased the severity of artifacts from 8.0 to 2.0 (P < 0.001) and decreased streak intensity from 871 to 153 HU (P < 0.001). The median diagnostic image quality rating improved from 2.5 to 8.0 (P < 0.001). The median energy level visually perceived as optimal for diagnostic evaluation was 113 keV (range, 100-130 keV). CONCLUSIONS: Sn140/100 kVp with a tube current ratio of 3:1, a collimation of 32 × 0.6 mm, and extrapolated energies of 105 to 120 keV are optimal parameters for a dedicated DSCT protocol that effectively reduces metal artifacts by energetic extrapolation. The protocol effectively reduces metal artifacts in all types of metal implants. The optimized reconstructions yielded relevant additional findings.

Image quality and radiation exposure with prospectively ECG-triggered axial scanning for coronary CT angiography: the multicenter, multivendor, randomized PROTECTION-III study.

OBJECTIVES: The purpose of this study was to evaluate image quality and radiation dose using a prospectively electrocardiogram (ECG)-triggered axial scan protocol compared with standard retrospective ECG-gated helical scanning for coronary computed tomography angiography. BACKGROUND: Concerns have been raised regarding radiation exposure during coronary computed tomography angiography. Although the use of prospectively ECG-triggered axial scan protocols may effectively lower radiation dose compared with helical scanning, it is unknown whether image quality is maintained in a clinical setting. METHODS: In a prospective, multicenter, multivendor trial, 400 patients with low and stable heart rates were randomized to either an axial or a helical coronary computed tomography angiography scan protocol. The primary endpoint was to demonstrate noninferiority in image quality with the axial scan protocol, which was assessed on a 4-point scale (1 = nondiagnostic, 4 = excellent image quality). Secondary endpoints included radiation dose and the rate of downstream testing during 30-day follow-up. RESULTS: Image quality in patients scanned with the axial scan protocol (score 3.36 ± 0.59) was not inferior compared with helical scan protocols (3.37 ± 0.59) (p for noninferiority <0.004). Axial scanning was associated with a 69% reduction in radiation exposure (dose-length product [estimated effective dose] 252 ± 147 mGy · cm [3.5 ± 2.1 mSv] vs. 802 ± 419 mGy · cm [11.2 ± 5.9 mSv] for axial vs. helical scan protocols, p < 0.001). The rate of downstream testing did not differ (13.8% vs. 15.9% for axial vs. helical scan protocols, p = 0.555). CONCLUSIONS: In patients with stable and low heart rates, the prospectively ECG-triggered axial scan protocol maintained image quality but reduced radiation exposure by 69% compared with helical scanning. Axial computed tomography data acquisition should be strongly recommended in suitable patients to avoid unnecessarily high radiation exposure.

Prognostic value of coronary computed tomographic angiography in patients with arterial hypertension.

Patients with arterial hypertension have a high risk of developing coronary artery disease (CAD), but noninvasive diagnosis of CAD remains difficult. We assessed the ability of coronary CT angiography (CCTA) to detect CAD and to predict subsequent cardiac events in hypertensive patients. We compared 906 hypertensive patients without known CAD undergoing CCTA with 906 matched normotensive patients. Besides calcium score and the degree of the most severe stenosis, the number of coronary segments with atherosclerotic changes was recorded. The primary endpoint was the occurrence of hard cardiac events defined as all cause death, nonfatal myocardial infarction or unstable angina requiring hospitalization. During a median follow-up of 29 months, there were 17 hard cardiac events in the hypertensive group and 13 events in the control group. The best predictor of events in hypertensive patients was the degree of the most severe stenosis (C-index 0.705, P < 0.001, both corrected for clinical risk). The annual event rate was 0.3% for patients without obstructive CAD and 1.5% for patients with obstructive CAD. In hypertensive patients without known CAD, coronary CT angiography allows for the identification of patients at high risk for incident cardiac events.

Cardiovascular risk assessment based on the quantification of coronary calcium in contrast-enhanced coronary computed tomography angiography.

AIMS: The extent of coronary artery calcification (CAC) has been shown to be a strong and independent predictor for cardiovascular events. Usually, CAC scoring is performed in non-contrast-enhanced computed tomography (CT) examinations. The ability and accuracy of cardiovascular risk classification according to the degree of CAC determined in contrast-enhanced coronary CT angiography (CCTA) has not been investigated so far. The aim of this analysis was to develop and validate a method for CAC risk classification in CCTA. METHODS AND RESULTS: In a test series of 100 patients who underwent both non-enhanced CAC scoring and CCTA, we developed a method to assess the extent of coronary calcification and the associated cardiovascular risk category in CCTA. The accuracy of the developed approach of CAC assessment in CCTA was determined in 500 consecutive patients in comparison to CAC scoring in the non-enhanced scan. CAC scoring results in the non-enhanced scan and CCTA scan showed a high correlation (r = 0.954; P < 0.001). CAC quantification in CCTA correctly identified 98% of patients without CAC as shown in the non-enhanced scan (184 of 188 patients). When compared with non-enhanced CAC scoring, CAC scoring in CCTA grouped more than 95% of high-risk patients correctly into the same risk category according to the 75th age- and gender-specific percentiles or the absolute calcium scores. CONCLUSION: Assessing cardiovascular risk associated with CAC is feasible and accurate in contrast-enhanced CCTA. This new technique may allow for reducing the radiation exposure of coronary CT studies while maintaining an accurate cardiovascular risk assessment, because the addition of non-enhanced scans to CCTA becomes unnecessary for comprehensive coronary CT studies.

Image quality and radiation exposure with a low tube voltage protocol for coronary CT angiography results of the PROTECTION II Trial.

OBJECTIVES: The purpose of this study was to evaluate image quality and radiation dose using a 100 kVp tube voltage scan protocol compared with standard 120 kVp for coronary computed tomography angiography (CTA). BACKGROUND: Concerns have been raised about radiation exposure during coronary CTA. The use of a 100 kVp tube voltage scan protocol effectively lowers coronary CTA radiation dose compared with standard 120 kVp, but it is unknown whether image quality is maintained. METHODS: We enrolled 400 nonobese patients who underwent coronary CTA: 202 patients were randomly assigned to a 100 kVp protocol and 198 patients to a 120 kVp protocol. The primary end point was to demonstrate noninferiority in image quality with the 100 kVp protocol, which was assessed by a 4-point grading score (1 = nondiagnostic, 4 = excellent image quality). For the noninferiority analysis, a margin of -0.2 image quality score points for the difference between both scan protocols was pre-defined. Secondary end points included radiation dose and need for additional diagnostic tests during follow-up. RESULTS: The mean image quality scores in patients scanned with 100 kVp and 120 kVp were 3.30 ± 0.67 and 3.28 ± 0.68, respectively (p = 0.742); image quality of the 100 kVp protocol was not inferior, as demonstrated by the 97.5% confidence interval of the difference, which did not cross the pre-defined noninferiority margin of -0.2. The 100 kVp protocol was associated with a 31% relative reduction in radiation exposure (dose-length product: 868 ± 317 mGy × cm with 120 kVp vs. 599 ± 255 mGy × cm with 100 kVp; p < 0.0001). At 30-day follow-up, the need for additional diagnostic studies did not differ (13.4% vs. 19.2% for 100 kVp vs. 120 kVp, respectively; p = 0.114). CONCLUSIONS: A coronary CTA protocol using 100 kVp tube voltage maintained image quality, but reduced radiation exposure by 31% as compared with the standard 120 kVp protocol. Thus, 100 kVp scan protocols should be considered for nonobese patients to keep radiation exposure as low as reasonably achievable. (Prospective Randomized Trial on Radiation Dose Estimates of Cardiac CT Angiography in Patients Scanned With a 100 kVp Protocol [PROTECTION II]; NCT00611780).

Prognostic value of coronary computed tomographic angiography in asymptomatic patients.

To assess the value of coronary computed tomographic angiography (CCTA) in the prediction of cardiac events in asymptomatic patients, 451 consecutive asymptomatic patients who underwent CCTA from December 2003 to November 2007 were retrospectively analyzed. The primary end point of the study was the occurrence of cardiac events, defined as cardiac death, nonfatal myocardial infarction, unstable angina requiring hospitalization, and late revascularization (>90 days after CCTA) during a median follow-up period of 27.5 months. Secondary end points were the prevalence of nonobstructive coronary lesions and the number of patients reclassified regarding their cardiovascular risk. Two hundred twenty-nine patients (54%) had nonobstructive coronary lesions, and 107 patients (24%) obstructive coronary artery disease. During follow-up, there were 2 cases of unstable angina and 8 revascularizations for stable angina. Patients with obstructive coronary artery disease had a significantly higher event rate than those without obstructive CAD (risk ratio 13.9, 95% confidence interval 4.0 to 48.0). In 217 patients (48%), the clinically assessed cardiovascular risk could be reclassified by CCTA from intermediate or high to low risk. In conclusion, although the event rate was low in asymptomatic patients, CCTA could reliably predict further cardiac events and could reclassify 2/3 of patients regarding their cardiovascular risk.

Comparison of sequential and helical scanning for radiation dose and image quality: results of the Prospective Multicenter Study on Radiation Dose Estimates of Cardiac CT Angiography (PROTECTION) I Study.

OBJECTIVE: Concerns have been raised about the radiation exposure of coronary CT angiography (CTA). Recently, a prospective ECG-triggered sequential coronary CTA technique was developed to reduce exposure to ionizing radiation. The purpose of this analysis was to determine the impact of a sequential scanning technique on image quality and radiation dose in a prespecified subgroup analysis of the Prospective Multicenter Study on Radiation Dose Estimates of Cardiac CT Angiography I (PROTECTION I) Study when compared with a standard helical scanning technique. MATERIALS AND METHODS: This analysis comprises 685 64-MDCT coronary angiography studies of 47 international study sites in which the image quality was assessed by an experienced coronary CTA investigator using a 4-point score (1 = nondiagnostic, 4 = excellent image quality). Image quality was analyzed in all patients studied with the sequential scanning mode (n = 99) and in randomly selected patients of the population studied with the helical acquisition mode (n = 586). Radiation dose estimates were derived from the dose-length product (DLP) and a conversion coefficient for the chest (0.014 mSv x mGy(-1) x cm(-1)). RESULTS: Although the sequential scanning mode significantly reduced radiation dose estimates by 68% from 11.2 mSv for the helical mode to 3.6 mSv for the sequential mode (p < 0.001), the median diagnostic image quality scores were comparable in both groups. The median diagnostic score for both scanning modes was 3.5 (interquartile range: sequential vs helical mode, 3.25-3.75 vs 3.0-3.75, respectively; p = 0.62). CONCLUSION: The results of the PROTECTION I Study suggest that the prospective ECG-triggered sequential coronary CTA technique significantly reduces radiation dose without impairing image quality when compared with the standard retrospective helical data acquisition in patients with a low and stable heart rate.

Prognostic value of coronary computed tomographic angiography in diabetic patients without known coronary artery disease.

OBJECTIVE: Diabetic patients have a high prevalence of coronary artery disease (CAD), but timely diagnosis of CAD remains challenging. We assessed the ability of coronary computed tomography angiography (CCTA) to detect CAD in diabetic patients and to predict subsequent cardiac events. RESEARCH DESIGN AND METHODS: We analyzed 140 diabetic patients without known CAD undergoing CCTA; 1,782 patients without diabetes were used as a control group. Besides calcium scoring and the degree of the most severe stenosis, the atherosclerotic burden score counting the number of segments having either a nonstenotic plaque or a stenosis was recorded. The primary end point was a composite of hard cardiac events defined as all-cause death, nonfatal myocardial infarction, or unstable angina requiring hospitalization. RESULTS: During a mean follow-up of 33 months, there were seven events in the diabetic group and 24 events in the control group. The best predictor in diabetic patients was the atherosclerotic burden score: the annual event rate ranged from 0.5% for patients with <5 lesions to 9.6% for patients with >9 lesions, resulting in a hazard ratio (HR) of 1.3 (95% CI 1.1-1.7) for each additional lesion (P = 0.005). For comparison, in nondiabetic patients the annual event rate ranged from 0.3 to 2.2%, respectively, resulting in an HR of 1.2 (95% CI 1.1-1.3, P < 0.001). The atherosclerotic burden score improved the prognostic value of conventional risk factors significantly (P < 0.001). CONCLUSIONS: In diabetic patients without known CAD, CCTA can identify a patient group at particularly high risk for subsequent hard cardiac events.

Impact of a reduced tube voltage on CT angiography and radiation dose: results of the PROTECTION I study.

OBJECTIVES: The aim of this study was to determine the impact of a reduced 100-kV tube voltage on image quality and radiation exposure in a pre-defined subgroup analysis of the international, multicenter radiation dose survey PROTECTION I (Prospective Multicenter Study on RadiaTion Dose Estimates Of Cardiac CT AngIOgraphy I) study. BACKGROUND: Cardiac computed tomography angiography (CCTA) has become a frequently used diagnostic tool in clinical practice. Despite continually improving CT technology, there remain concerns regarding the associated radiation exposure. A reduced tube voltage of 100 kV has been proposed as an effective means for dose reduction in nonobese patients. METHODS: The study assessed the relevant radiation dose parameters as well as quantitative and qualitative diagnostic image quality data in a subgroup of 321 patients (100 kV: 82 patients; 120 kV: 239 patients), who were scanned at study sites that applied a 100-kV tube voltage in at least 1 patient. Diagnostic image quality was assessed by an experienced CCTA investigator with a 4-point score (1: nondiagnostic to 4: excellent image quality). Effective radiation dose was estimated from the dose-length-product of each CCTA study. RESULTS: The use of the 100-kV scan protocol was associated with 53% reduction in CCTA median radiation dose estimates, when compared with the conventional 120-kV scan protocol (p < 0.001). Although image noise significantly increased by 26.3% with 100 kV, signal- as well as contrast-to-noise ratios also increased by 7.9% (p = 0.254) and 10.8% (p = 0.027), respectively. Reduction of tube voltage did not impair diagnostic image quality (median diagnostic score: 3.5 [3.25 to 3.75] vs. 3.5 [3.0 to 3.75] for 100 kV vs. 120 kV; p = 0.22). CONCLUSIONS: In this nonrandomized PROTECTION I dose survey, reducing the CCTA tube voltage to 100 kV in nonobese patients is associated with a significant reduction in radiation exposure while maintaining diagnostic image quality. Thus, the 100-kV scan technique should be considered for CCTA dose reduction in adequately selected patients.

Feasibility of dual-source cardiac CT angiography with high-pitch scan protocols.

BACKGROUND: Cardiac CT angiography (CCTA) has become a frequently used diagnostic tool in clinical practice, but concern remains about the radiation exposure. Because of the second x-ray acquisition system, dual-source CT systems might allow for high-pitch CT data acquisition and thus for examination of the whole heart during a single heart beat, with the potential for radiation dose reduction. OBJECTIVE: We assessed the feasibility of a high-pitch scan mode with a dual-source CT system. METHODS: High-pitch modes were used in patients undergoing CCTA with a dual-source CT system. Diagnostic image quality for cardiac structures and coronary arteries was assessed. Radiation dose was estimated from the scanner-generated dose-length product (DLP). RESULTS: CCTA was performed in 14 patients during a single heart beat applying a pitch value of 3.4. Mean heart rate during examination was 56.4+/-8.1 beats/min. Diagnostic image quality for the assessment of larger cardiac structures was obtained in all patients, whereas diagnostic image quality could be achieved in 82% of all coronary segments. With a mean DLP of 145+/-47 mGy x cm, the resulting estimated radiation dose was 2.0+/-0.7 mSv. CONCLUSIONS: This proof-of-concept study shows the ability of dual-source CT scanners to scan the whole heart during one single heart beat at low radiation dose.