Search

Altres ajuts: This work was supported by Celyad, SA (Mont-Saint-Guibert, Belgium). Celyad has received research grants from the Walloon Region (Belgium, DG06 funding). Cardiopoietic cells, produced through cardiogenic conditioning of patients' mesenchymal stem cells, have shown preliminary efficacy. The Congestive Heart Failure Cardiopoietic Regenerative Therapy (CHART-1) trial aimed to validate cardiopoiesis-based biotherapy in a larger heart failure cohort. This multinational, randomized, double-blind, sham-controlled study was conducted in 39 hospitals. Patients with symptomatic ischaemic heart failure on guideline-directed therapy (n = 484) were screened; n = 348 underwent bone marrow harvest and mesenchymal stem cell expansion. Those achieving > 24 million mesenchymal stem cells (n = 315) were randomized to cardiopoietic cells delivered endomyocardially with a retention-enhanced catheter (n = 157) or sham procedure (n = 158). Procedures were performed as randomized in 271 patients (n = 120 cardiopoietic cells, n = 151 sham). The primary efficacy endpoint was a Finkelstein–Schoenfeld hierarchical composite (all-cause mortality, worsening heart failure, Minnesota Living with Heart Failure Questionnaire score, 6-min walk distance, left ventricular end-systolic volume, and ejection fraction) at 39 weeks. The primary outcome was neutral (Mann–Whitney estimator 0.54, 95% confidence interval [CI] 0.47–0.61 [value > 0.5 favours cell treatment], P = 0.27). Exploratory analyses suggested a benefit of cell treatment on the primary composite in patients with baseline left ventricular end-diastolic volume 200–370 mL (60% of patients) (Mann–Whitney estimator 0.61, 95% CI 0.52–0.70, P = 0.015). No difference was observed in serious adverse events. One (0.9%) cardiopoietic cell patient and 9 (5.4%) sham patients experienced aborted or sudden cardiac death. The primary endpoint was neutral, with safety demonstrated across the cohort. Further evaluation of cardiopoietic cell therapy in patients with elevated end-diastolic volume is warranted.

Aims: The emerging role of coronary computed tomography angiography (CCTA) as a non-invasive tool for atherosclerosis evaluation is supported by data reporting a good correlation between CCTA and intravascular ultrasound (IVUS) for plaque volume quantification. Aim of the present study was to evaluate whether a last generation CT-scanner may improve coronary plaque volume assessment using IVUS as standard-of-reference. Methods and results: From a registry of 1915 consecutive, all-comers, patients who underwent a clinically indicated IVUS evaluation we enrolled 59 patients who underwent CCTA with a 64-slice CT (Group 1) and 59 patients who underwent CCTA with whole-heart coverage CT scanner (Group 2). Patients who underwent CCTA with unfavourable heart rhythm were not excluded from the analysis. Image quality (4-point Likert scale) focused on plaque analysis was evaluated. Plaque volume quantification by CCTA was compared to IVUS. No difference in clinical characteristics was found between Group 1 and Group 2. Plaque volume quantification by CCTA was considered not feasible in 11 plaques of Group 1 and in 4 plaques of Group 2 (P = 0.09). Higher correlation for plaque volume quantification by CCTA vs. IVUS was demonstrated in Group 2 when compared with Group 1 (r = 0.9888 vs. 0.9499; P < 0.0001). The Bland-Altman analysis showed plaque volume overestimation by CCTA of 11.9 mm3 in Group 1 and 4 mm2 in Group 2 (P < 0.001). Effective radiation dose of CCTA was significantly lower in Group 2 vs. Group 1 (2.7 ± 0.9 vs. 8.1 ± 3.6 mSv, respectively; P < 0.001). Conclusions: CCTA using a new scanner generation showed to be an accurate non-invasive tool to assess and quantify coronary plaque volume.

Objectives: The goal of this study was to assess the diagnostic performance of coronary computed tomography angiography (CTA) alone, adenosine-stress myocardial perfusion assessed by computed tomography (CTP) alone, and coronary CTA + CTP by using a 16-cm Z-axis coverage scanner versus invasive coronary angiography (ICA) and fractional flow reserve (FFR) as the clinical standard. Background: Diagnostic performance of coronary CTA for in-stent restenosis detection is still challenging. Recently, CTP showed additional diagnostic power over coronary CTA in patients with suspected coronary artery disease. However, few data are available on CTP performance in patients with previous stent implantation. Methods: Consecutive stable patients with previous coronary stenting referred for ICA were enrolled. All patients underwent stress myocardial CTP and rest CTP + coronary CTA. Invasive FFR was performed during ICA when clinically indicated. The diagnostic rate and diagnostic accuracy of coronary CTA, CTP, and coronary CTA + CTP were evaluated in stent-, territory-, and patient-based analyses. Results: In the 150 enrolled patients (132 men; mean age 65.1 ± 9.1 years), the CTP diagnostic rate was significantly higher than that of coronary CTA in all analyses (territory based [96.7% vs. 91.1%; p < 0.0001] and patient based [96% vs. 68%; p < 0.0001]). When ICA was used as gold standard, CTP diagnostic accuracy was significantly higher than that of coronary CTA in all analyses (territory based [92.1% vs. 85.5%, p < 0.03] and patient based [86.7% vs. 76.7%, p < 0.03]). The concordant coronary CTA + CTP assessment exhibited the highest diagnostic accuracy values versus ICA (95.8% in the territory-based analysis). The diagnostic accuracy of CTP was significantly higher than that of coronary CTA (75% vs. 30.5%; p < 0.001). The radiation exposure of coronary CTA + CTP was 4.15 ± 1.5 mSv. Conclusions: In patients with coronary stents, CTP significantly improved the diagnostic rate and accuracy of coronary CTA alone compared with both ICA and invasive FFR as gold standard.

Rationale and Objectives: To evaluate image quality, coronary interpretability and radiation exposure of coronary CT angiography (CCTA)performed in patients with atrial fibrillation (AF)with the latest scanner generation, comparing two different technical approaches. A new scanner that combines a 0.23 mm spatial resolution, a new generation of iterative reconstruction, fast gantry rotation time and the intracycle motion-correction algorithm to improve the temporal resolution was recently introduced in the clinical field. Materials and Methods: We enrolled 105 consecutive patients with chronic AF who performed CCTA with a whole-heart coverage high-definition CT scanner (16-cm z-axis coverage with 256 detector rows, 0.28 s gantry rotation time). Five of them were excluded for impaired renal function. Patients were randomized between a double acquisition protocol (50 patients, group 1)or a single acquisition protocol (50 patients, group 2). The image quality, coronary segment interpretability and effective dose (ED)of CCTA were assessed. Results: The mean HR during the scan was 85.6±21 bpm in group 1 vs. 83.7±23 bpm in Group 2, respectively (p < ns). In group 2, overall image quality was high and comparable with that of group 1 (Likert scale =3.2 ± 1.4 vs. 3.3 ± 1.2, p = ns, in group 1 and 2, respectively). Coronary interpretability was high and similar between the two groups (97.5% and 97.1% in group 1 and 2, p = ns, respectively). Mean ED was significantly higher in group 1 than in group 2 (5.3 ± 1.8 mSv vs. 2.7 ± 0.7 mSv, p < 0.001). Conclusion: The novel whole-heart coverage CT scanner allows to perform CCTA with a single-acquisition protocol with high image quality and low radiation exposure in AF patients.

Aims To evaluate image quality, interpretability, diagnostic accuracy and radiation exposure of coronary CT angiography (CCTA) performed with a new scanner equipped with 0.23-mm spatial resolution, new generation iterative reconstruction, 0.28-second gantry rotation time and intra-cycle motion-correction algorithm in consecutive patients with coronary stents, including those with high heart rate (HR) and atrial fibrillation (AF). Materials and methods We enrolled 100 consecutive patients (85 males, mean age 65 ± 10 years) with previous coronary stent implantation scheduled for clinically indicated non-emergent invasive coronary angiography (ICA). Image quality, coronary interpretability and diagnostic accuracy vs. ICA were evaluated and the effective dose (ED) was recorded. Results Mean HR during the scan was 67 ± 13 bpm. Twenty-six patients had >65 bpm HR during scanning and 13 patients had AF. Overall, image quality was high (Likert = 3.2 ± 0.9). Stent interpretability was 95.8% (184/192 stents). Among 192 stented segments, CCTA correctly identified 22 out of 24 with >50% in-stent restenosis (ISR) (sensitivity 92%). In a stent-based analysis, specificity, positive and negative predictive values and diagnostic accuracy for ISR detection were 91%, 99%, 60% and 91%, respectively. In a patient-based analysis, CCTA diagnostic accuracy was 85%. Overall, mean ED of CCTA was 2.4 ± 1.2 mSv. Conclusions A whole-organ CT scanner was able to evaluate coronary stents with good diagnostic performance and low radiation exposure, also in presence of unfavorable HR and heart rhythm. Translational aspect The present study is the first to evaluate the CCTA capability of detecting in-stent restenosis in consecutive patients, including those with high HR and AF, using a recent scanner generation that combines improved spatial and temporal resolution with wide coverage. Using the whole-organ high-definition CT scanner we obtained high quality images of coronary stents with good interpretability and diagnostic accuracy combined with low radiation exposure, even in patients with unfavorable HR or heart rhythm for CCTA evaluation.

Background Recent studies demonstrated a significant improvement in the diagnostic performance of coronary CT angiography (CCTA) for the evaluation of in-stent restenosis (ISR). However, coronary stent assessment is still challenging, especially because of beam-hardening artifacts due to metallic stent struts and high atherosclerotic burden of non-stented segments. Adenosine-stress myocardial perfusion assessed by CT (CTP) recently demonstrated to be a feasible and accurate tool for evaluating the functional significance of coronary stenoses in patients with suspected coronary artery disease (CAD). Yet, scarce data are available on the performance of CTP in patients with previous stent implantation. Aim of the study We aim to assess the diagnostic performance of CCTA alone, CTP alone and CCTA plus CTP performed with a new scanner generation using quantitative invasive coronary angiography (ICA) and invasive fractional flow reserve (FFR) as standard of reference. Methods We will enroll 300 consecutive patients with previous stent implantation, referred for non-emergent and clinically indicated invasive coronary angiography (ICA) due to suspected ISR or progression of CAD in native coronary segments. All patients will be subjected to stress myocardial CTP and a rest CCTA. The first 150 subjects will undergo static CTP scan, while the following 150 patients will undergo dynamic CTP scan. Measurement of invasive FFR will be performed during ICA when clinically indicated. Results The primary study end points will be: 1) assessment of the diagnostic performance (diagnostic rate, sensitivity, specificity, positive predictive value, negative predictive value and diagnostic accuracy) of CCTA, CTP, combined CCTA-CTP and concordant CCTA-CTP vs. ICA as standard of reference in a territory-based and patient-based analysis; 2) assessment of sensitivity, specificity, positive predictive value, negative predictive value and diagnostic accuracy of CCTA, CTP, combined CCTA-CTP and concordant CCTA-CTP vs. invasive FFR as standard of reference in a territory-based analysis. Conclusions The ADVANTAGE study aims to provide an answer to the intriguing question whether the combined anatomical and functional assessment with CCTA plus CTP may have higher diagnostic performance as compared to CCTA alone in identifying stented patients with significant ISR or CAD progression.