Aspirin with or without Clopidogrel after Transcatheter Aortic-Valve Implantation.

BACKGROUND: The effect of single as compared with dual antiplatelet treatment on bleeding and thromboembolic events after transcatheter aortic-valve implantation (TAVI) in patients who do not have an indication for long-term anticoagulation has not been well studied. METHODS: In a randomized, controlled trial, we assigned a subgroup of patients who were undergoing TAVI and did not have an indication for long-term anticoagulation, in a 1:1 ratio, to receive aspirin alone or aspirin plus clopidogrel for 3 months. The two primary outcomes were all bleeding (including minor, major, and life-threatening or disabling bleeding) and non-procedure-related bleeding over a period of 12 months. Most bleeding at the TAVI puncture site was counted as non-procedure-related. The two secondary outcomes were a composite of death from cardiovascular causes, non-procedure-related bleeding, stroke, or myocardial infarction (secondary composite 1) and a composite of death from cardiovascular causes, ischemic stroke, or myocardial infarction (secondary composite 2) at 1 year, with both outcomes tested sequentially for noninferiority (noninferiority margin, 7.5 percentage points) and superiority. RESULTS: A total of 331 patients were assigned to receive aspirin alone and 334 were assigned to receive aspirin plus clopidogrel. A bleeding event occurred in 50 patients (15.1%) receiving aspirin alone and in 89 (26.6%) receiving aspirin plus clopidogrel (risk ratio, 0.57; 95% confidence interval [CI], 0.42 to 0.77; P = 0.001). Non-procedure-related bleeding occurred in 50 patients (15.1%) and 83 patients (24.9%), respectively (risk ratio, 0.61; 95% CI, 0.44 to 0.83; P = 0.005). A secondary composite 1 event occurred in 76 patients (23.0%) receiving aspirin alone and in 104 (31.1%) receiving aspirin plus clopidogrel (difference, -8.2 percentage points; 95% CI for noninferiority, -14.9 to -1.5; P<0.001; risk ratio, 0.74; 95% CI for superiority, 0.57 to 0.95; P = 0.04). A secondary composite 2 event occurred in 32 patients (9.7%) and 33 patients (9.9%), respectively (difference, -0.2 percentage points; 95% CI for noninferiority, -4.7 to 4.3; P = 0.004; risk ratio, 0.98; 95% CI for superiority, 0.62 to 1.55; P = 0.93). A total of 44 patients (13.3%) and 32 (9.6%), respectively, received oral anticoagulation during the trial. CONCLUSIONS: Among patients undergoing TAVI who did not have an indication for oral anticoagulation, the incidence of bleeding and the composite of bleeding or thromboembolic events at 1 year were significantly less frequent with aspirin than with aspirin plus clopidogrel administered for 3 months. (Funded by the Netherlands Organization for Health Research and Development; POPular TAVI EU Clinical Trials Register number, 2013-003125-28; ClinicalTrials.gov number, NCT02247128.).

Anticoagulation with or without Clopidogrel after Transcatheter Aortic-Valve Implantation.

BACKGROUND: The roles of anticoagulation alone or with an antiplatelet agent after transcatheter aortic-valve implantation (TAVI) have not been well studied. METHODS: We performed a randomized trial of clopidogrel in patients undergoing TAVI who were receiving oral anticoagulation for appropriate indications. Patients were assigned before TAVI in a 1:1 ratio not to receive clopidogrel or to receive clopidogrel for 3 months. The two primary outcomes were all bleeding and non-procedure-related bleeding over a period of 12 months. Procedure-related bleeding was defined as Bleeding Academic Research Consortium type 4 severe bleeding, and therefore most bleeding at the puncture site was counted as non-procedure-related. The two secondary outcomes were a composite of death from cardiovascular causes, non-procedure-related bleeding, stroke, or myocardial infarction at 12 months (secondary composite 1) and a composite of death from cardiovascular causes, ischemic stroke, or myocardial infarction (secondary composite 2), both tested for noninferiority (noninferiority margin, 7.5 percentage points) and superiority. RESULTS: Bleeding occurred in 34 of the 157 patients (21.7%) receiving oral anticoagulation alone and in 54 of the 156 (34.6%) receiving oral anticoagulation plus clopidogrel (risk ratio, 0.63; 95% confidence interval [CI], 0.43 to 0.90; P = 0.01); most bleeding events were at the TAVI access site. Non-procedure-related bleeding occurred in 34 patients (21.7%) and in 53 (34.0%), respectively (risk ratio, 0.64; 95% CI, 0.44 to 0.92; P = 0.02). Most bleeding occurred in the first month and was minor. A secondary composite 1 event occurred in 49 patients (31.2%) receiving oral anticoagulation alone and in 71 (45.5%) receiving oral anticoagulation plus clopidogrel (difference, -14.3 percentage points; 95% CI for noninferiority, -25.0 to -3.6; risk ratio, 0.69; 95% CI for superiority, 0.51 to 0.92). A secondary composite 2 event occurred in 21 patients (13.4%) and in 27 (17.3%), respectively (difference, -3.9 percentage points; 95% CI for noninferiority, -11.9 to 4.0; risk ratio, 0.77; 95% CI for superiority, 0.46 to 1.31). CONCLUSIONS: In patients undergoing TAVI who were receiving oral anticoagulation, the incidence of serious bleeding over a period of 1 month or 1 year was lower with oral anticoagulation alone than with oral anticoagulation plus clopidogrel. (Funded by the Netherlands Organization for Health Research and Development; POPular TAVI EU Clinical Trials Register number, 2013-003125-28; ClinicalTrials.gov number, NCT02247128.).

Prognostic Value and Reproducibility of AI-assisted Analysis of Lung Involvement in COVID-19 on Low-Dose Submillisievert Chest CT: Sample Size Implications for Clinical Trials.

PURPOSE: To compare the prognostic value and reproducibility of visual versus AI-assisted analysis of lung involvement on submillisievert low-dose chest CT in COVID-19 patients. MATERIALS AND METHODS: This was a HIPAA-compliant, institutional review board-approved retrospective study. From March 15 to June 1, 2020, 250 RT-PCR confirmed COVID-19 patients were studied with low-dose chest CT at admission. Visual and AI-assisted analysis of lung involvement was performed by using a semi-quantitative CT score and a quantitative percentage of lung involvement. Adverse outcome was defined as intensive care unit (ICU) admission or death. Cox regression analysis, Kaplan-Meier curves, and cross-validated receiver operating characteristic curve with area under the curve (AUROC) analysis was performed to compare model performance. Intraclass correlation coefficients (ICCs) and Bland- Altman analysis was used to assess intra- and interreader reproducibility. RESULTS: Adverse outcome occurred in 39 patients (11 deaths, 28 ICU admissions). AUC values from AI-assisted analysis were significantly higher than those from visual analysis for both semi-quantitative CT scores and percentages of lung involvement (all P<0.001). Intrareader and interreader agreement rates were significantly higher for AI-assisted analysis than visual analysis (all ICC ≥0.960 versus ≥0.885). AI-assisted variability for quantitative percentage of lung involvement was 17.2% (coefficient of variation) versus 34.7% for visual analysis. The sample size to detect a 5% change in lung involvement with 90% power and an α error of 0.05 was 250 patients with AI-assisted analysis and 1014 patients with visual analysis. CONCLUSION: AI-assisted analysis of lung involvement on submillisievert low-dose chest CT outperformed conventional visual analysis in predicting outcome in COVID-19 patients while reducing CT variability. Lung involvement on chest CT could be used as a reliable metric in future clinical trials.

Quarter-millimeter spectral coronary stent imaging with photon-counting CT: Initial experience.

PURPOSE: To evaluate the performance and clinical feasibility of 0.25 mm resolution mode of a dual-energy photon-counting detector (PCD) computed tomography (CT) system for coronary stent imaging and to compare the results to state-of-the-art dual-energy energy-integrating detector (EID) CT. MATERIALS AND METHODS: Coronary stents with different diameters (2.0-4.0 mm) were examined inside a coronary artery phantom consisting of plastic tubes filled with iodine-based and gadolinium-based contrast material diluted to approximate clinical concentrations (n = 18). EID images were acquired using 2nd and 3rd generation dual-source CT systems (SOMATOM Flash and SOMATOM Force, Siemens Healthcare) at 0.60 mm (defined as standard-resolution (SR)) isotropic voxel size. Radiation-dose matched PCD images were acquired using a human prototype PCD system (Siemens Healthcare) at 0.50 mm (SR) and 0.25 mm (HR) imaging modes. Images were reconstructed using optimized convolution kernels. RESULTS: Dual-energy HR PCD images significantly better stent lumen visualization (median: 69.5%, IQR: 61.2-78.9%) over dual-energy EID, and standard-resolution PCD images (median: 53.2-57.4%, all P < 0.01). HR PCD acquisitions reconstructed at SR image voxel size showed 25.3% lower image noise compared to SR PCD acquisitions (P < 0.001). High-resolution iodine and gadolinium maps, as well as virtual monoenergetic images, were calculated from the PCD data and enabled estimation of contrast agent concentration in the lumen without interference from the coronary stent. CONCLUSION: HR spectral PCD imaging significantly improves coronary stent lumen visibility over dual-energy EID. When the PCD-HR data was reconstructed into standard voxel sizes (0.5 mm isotropic) the image noise decreased by 25% compared to SR acquisition of PCD. Both dual-energy systems were consistent in estimating contrast agent concentrations.

Unifocal Right-Sided Ablation Treatment for Neurally Mediated Syncope and Functional Sinus Node Dysfunction Under Computed Tomographic Guidance.

Background Biatrial, extensive, and complex ablation strategies have been published for the treatment of neurally mediated syncope, sinus node dysfunction, and functional atrioventricular block. We have developed a less extensive and more specific approach compared with previously published cardioneuroablation strategies, called cardio-neuromodulation. It is based on tailored vagolysis of the sinoatrial node through partial ablation of the anterior right-ganglionated plexus, preferentially through a right-sided approach. Methods Patients with syncope were enrolled between December 2016 and December 2017. They were assigned to group A if they had a positive head-up tilt test and to group B if they presented with a pause ≥3 seconds. The area to target during cardio-neuromodulation was designed offline on a computed tomographic scan. Slow heart rates and pauses were compared during 24-hour rhythm registration at baseline, at 1-month follow-up, and 6-month follow-up. Syncope burden was assessed before the procedure and at 3- and 6-month follow-up. Results Twenty patients underwent cardio-neuromodulation through a right-sided approach (12 in group A, 8 in group B). The first application of radiofrequency energy led to a P-P interval shortening >120 ms in all 20 patients. After a mean±SD ablation time of 7±4 minutes and mean ablated surface area of 11±6 mm2, the P-P interval shortened by 219±160 ms ( P<0.001). The number of beats <50/min during 24-hour rhythm registration was reduced by a median of 100% at 6-month follow-up ( P<0.001). Syncope burden was reduced by 95% at 6-month follow-up ( P<0.001). Conclusions These data indicate that cardio-neuromodulation, through a right-sided and computed tomographic-guided procedure, is safe, fast, and highly reproducible in preventing inappropriate functional sinus bradycardia and syncope recurrence.

Formation of thermal coagulum on multielectrode catheters during phased radiofrequency energy ablation of persistent atrial fibrillation.

BACKGROUND: Radiofrequency ablation (RFA) can unfavorably cause coagulum on the ablation electrode. The aim of this study was to assess this phenomenon on three different multielectrode catheters used to treat persistent atrial fibrillation with duty-cycled RFA. METHODS AND RESULTS: Twenty-six consecutive patients have been treated with the pulmonary vein ablation catheter (PVAC) and the multiarray ablation catheter (MAAC). In 13 patients, additional ablation with the multiarray septal catheter (MASC) has been performed. The multichannel RF generator GENius™ (Medtronic Inc., Minneapolis, MN, USA) independently delivered energy in a bipolar and unipolar mode (ratio of 4/1, 2/1, or 1/1) to any of the electrodes. Versions 14.2, 14.3, and 14.4 of the generator were used. Coagulum presence was determined postablation by careful visual inspection of the catheter electrodes. No coagulum formation was visualized on the PVACs. Coagulum formation was visualized in 59% of the electrodes of the MAACs using a 2/1 mode and the 14.2 software version versus 69% using the 14.4 version and a 2/1 mode (P = 0.7) versus 14% of the electrodes applying a 1/1 ratio and the 14.4 software version (P < 0.001). CONCLUSIONS: Duty-cycled RFA in 2/1 bipolar/unipolar ratio generates a substantial frequency of coagulum formation on the multielectrode catheters MAAC and MASC. The use of the 14.4 version of the software to drive the RF generator and the use of energy in the default 1/1 bipolar/unipolar ratio could significantly reduce the frequency of coagulum formation, but so far, could not completely overcome it. The PVAC did not form coagulum, regardless of generator version or energy ratio used.

Psychometric properties of the Flemish version of the MacNew heart disease health-related quality of life questionnaire.

BACKGROUND: Assessment of health-related quality of life, increasingly being used as an outcome measure in cardiovascular disease research studies and clinical practice, requires questionnaires with sound psychometric properties. The aim of this study was to evaluate the psychometric properties of the Flemish version of the MacNew Heart Disease Health-related Quality of Life questionnaire in Flemish-speaking Belgian patients. METHOD: Between 2002 and 2008, as part of the international HeartQol Project, 344 Belgian patients with a diagnosis of angina, ischaemic heart failure or myocardial infarction completed the Flemish versions of the MacNew, the Short-Form 36 and the Hospital Anxiety and Depression Scale. Ceiling and floor effects of the MacNew were analysed. Internal consistency was assessed by Cronbach's a and reproducibility (intra-class correlation coefficients) was assessed in a subsample of patients over a 2-3 week period with repeated tests. Convergent validity (Pearson's correlation between MacNew and Short-Form 36 constructs) and discriminant validity ('known-group' approach) were tested. RESULTS: The Flemish version of the MacNew appears to be a reliable instrument with a high internal consistency, demonstrating strong discriminative validity and satisfactory construct validity. The results of factor analysis are similar to the factor structure of the original MacNew explaining 59.8% of the total variance. CONCLUSION: The Flemish version of the MacNew demonstrates good psychometric properties. It can be recommended as a specific instrument for assessing and evaluating health-related quality of life in Flemish-speaking patients in each of the three major ischaemic heart disease diagnoses: angina, ischaemic heart failure and myocardial infarction. However, responsiveness to change could not be tested in this cross-sectional study and should be further investigated in a larger sample of patients following an intervention likely to induce a change in health-related quality of life.

Systematic primary aspiration in acute myocardial percutaneous intervention: a multicentre randomised controlled trial of the export aspiration catheter.

AIMS: It is unclear whether primary aspiration can prevent distal embolisation and thereby improve myocardial perfusion in patients presenting with acute myocardial infarction (AMI) within 12 hours after onset. METHODS AND RESULTS: At 24 centres in Europe and India, 249 AMI patients were randomised to primary aspiration with the Export aspiration catheter (Medtronic Vascular, Santa Rosa, CA, U.S.A.) followed by stenting (N=120) or to conventional stenting without primary aspiration (N=129). There were no significant differences between the 2 groups in baseline characteristics or target lesion TIMI scores. Procedure time was 36.7 +/- 18.0 minutes for primary aspiration followed by stenting versus 34.5 +/- 21.5 minutes for conventional stenting (P=0.08). Debris was obtained by primary aspiration from 85.3% of the arteries. The use of a bailout technique was significantly lower for primary aspiration than for conventional stenting (5.8% vs. 14.7%, P=0.02). For the primary endpoint of the combined rate of myocardial blush grade 3 and/or ST-segment resolution >50% to assess myocardial perfusion, primary aspiration followed by stenting was superior to conventional stenting (85.0% vs. 71.9%, P=0.025). Immediately postprocedure, the rate of myocardial blush grade 3 was 35.8% for primary aspiration followed by stenting versus 25.4% for conventional stenting (P=0.094). At 60 minutes post procedure, the rate of ST-segment resolution >50% was 73.5% for primary aspiration followed by stenting versus 64.8% for conventional stenting (P=0.218). Primary aspiration was also associated with a significantly higher postprocedure corrected TIMI frame count than conventional stenting (20 +/- 14.9 vs. 22.8 +/- 14, P=0.02). At 30 days, there were no differences between the treatments in the rate of major adverse cardiac and cerebral events. CONCLUSIONS: Compared with conventional stenting, primary aspiration with the Export aspiration catheter followed by stenting improved myocardial reperfusion in AMI patients presenting with TIMI flow grade 0 to 1. Further study of primary aspiration involving larger numbers of patients is warranted to assess its effect on longer-term clinical outcome.