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Importance The effectiveness and safety of computed tomography (CT) and invasive coronary angiography (ICA) in different age groups is unknown. Objective To determine the association of age with outcomes of CT and ICA in patients with stable chest pain. Design, Setting, and Participants The assessor-blinded Diagnostic Imaging Strategies for Patients With Stable Chest Pain and Intermediate Risk of Coronary Artery Disease (DISCHARGE) randomized clinical trial was conducted between October 2015 and April 2019 in 26 European centers. Patients referred for ICA with stable chest pain and an intermediate probability of obstructive coronary artery disease were analyzed in an intention-to-treat analysis. Data were analyzed from July 2022 to January 2023. Interventions Patients were randomly assigned to a CT-first strategy or a direct-to-ICA strategy. Main Outcomes and Measures MACE (ie, cardiovascular death, nonfatal myocardial infarction, or stroke) and major procedure-related complications. The primary prespecified outcome of this secondary analysis of age was major adverse cardiovascular events (MACE) at a median follow-up of 3.5 years. Results Among 3561 patients (mean [SD] age, 60.1 [10.1] years; 2002 female [56.2%]), 2360 (66.3%) were younger than 65 years, 982 (27.6%) were between ages 65 to 75 years, and 219 (6.1%) were older than 75 years. The primary outcome was MACE at a median (IQR) follow-up of 3.5 (2.9-4.2) years for 3523 patients (99%). Modeling age as a continuous variable, age, and randomization group were not associated with MACE (hazard ratio, 1.02; 95% CI, 0.98-1.07; P for interaction = .31). Age and randomization group were associated with major procedure-related complications (odds ratio, 1.15; 95% CI, 1.05-1.27; P for interaction = .005), which were lower in younger patients. Conclusions and Relevance Age did not modify the effect of randomization group on the primary outcome of MACE but did modify, IMPORTANCE: The effectiveness and safety of computed tomography (CT) and invasive coronary angiography (ICA) in different age groups is unknown.OBJECTIVE: To determine the association of age with outcomes of CT and ICA in patients with stable chest pain.DESIGN, SETTING, AND PARTICIPANTS: The assessor-blinded Diagnostic Imaging Strategies for Patients With Stable Chest Pain and Intermediate Risk of Coronary Artery Disease (DISCHARGE) randomized clinical trial was conducted between October 2015 and April 2019 in 26 European centers. Patients referred for ICA with stable chest pain and an intermediate probability of obstructive coronary artery disease were analyzed in an intention-to-treat analysis. Data were analyzed from July 2022 to January 2023.INTERVENTIONS: Patients were randomly assigned to a CT-first strategy or a direct-to-ICA strategy.MAIN OUTCOMES AND MEASURES: MACE (ie, cardiovascular death, nonfatal myocardial infarction, or stroke) and major procedure-related complications. The primary prespecified outcome of this secondary analysis of age was major adverse cardiovascular events (MACE) at a median follow-up of 3.5 years.RESULTS: Among 3561 patients (mean [SD] age, 60.1 [10.1] years; 2002 female [56.2%]), 2360 (66.3%) were younger than 65 years, 982 (27.6%) were between ages 65 to 75 years, and 219 (6.1%) were older than 75 years. The primary outcome was MACE at a median (IQR) follow-up of 3.5 (2.9-4.2) years for 3523 patients (99%). Modeling age as a continuous variable, age, and randomization group were not associated with MACE (hazard ratio, 1.02; 95% CI, 0.98-1.07; P for interaction = .31). Age and randomization group were associated with major procedure-related complications (odds ratio, 1.15; 95% CI, 1.05-1.27; P for interaction = .005), which were lower in younger patients.CONCLUSIONS AND RELEVANCE: Age did not modify the effect of randomization group on the primary outcome of MACE but did modify the effe

Objective: To implement detailed EU cardiac computed tomography angiography (CCTA) quality criteria in the multicentre DISCHARGE trial (FP72007-2013, EC-GA 603266), we reviewed image quality and adherence to CCTA protocol and to the recommendations of invasive coronary angiography (ICA) in a pilot study. Materials and methods: From every clinical centre, imaging datasets of three patients per arm were assessed for adherence to the inclusion/exclusion criteria of the pilot study, predefined standards for the CCTA protocol and ICA recommendations, image quality and non-diagnostic (NDX) rate. These parameters were compared via multinomial regression and ANOVA. If a site did not reach the minimum quality level, additional datasets had to be sent before entering into the final accepted database (FADB). Results: We analysed 226 cases (150 CCTA/76 ICA). The inclusion/exclusion criteria were not met by 6 of the 226 (2.7%) datasets. The predefined standard was not met by 13 of 76 ICA datasets (17.1%). This percentage decreased between the initial CCTA database and the FADB (multinomial regression, 53 of 70 vs 17 of 75 [76%] vs [23%]). The signal-to-noise ratio and contrast-to-noise ratio of the FADB did not improve significantly (ANOVA, p = 0.20; p = 0.09). The CTA NDX rate was reduced, but not significantly (initial CCTA database 15 of 70 [21.4%]) and FADB 9 of 75 [12%]; p = 0.13). Conclusion: We were able to increase conformity to the inclusion/exclusion criteria and CCTA protocol, improve image quality and decrease the CCTA NDX rate by implementing EU CCTA quality criteria and ICA recommendations. Key Points: • Failure to meet protocol adherence in cardiac CTA was high in the pilot study (77.6%). • Image quality varies between sites and can be improved by feedback given by the core lab. • Conformance with new EU cardiac CT quality criteria might render cardiac CTA findings more consistent and comparable.

OBJECTIVES: We undertook an independent bench test assessing the performance of the TRUE dilatation (TD) balloon valvuloplasty catheter (Bard Vascular Inc., Tempe, AZ) beyond its rated burst pressure (RBP).BACKGROUND: The TD balloon has a RBP of six atmospheres (atm), and its performance beyond this RBP is poorly understood. Techniques such as bioprosthetic valve fracture require inflation pressures beyond manufacturer recommendations.METHODS: A 20, 22, 24, 26, and 28 mm TD balloon were inflated to increasing pressures in increments of 3 atm until balloon failure. Measurements were performed at the proximal, middle, and distal balloon segments with scientific digital calipers. Z-MED balloons (Braun Interventional Systems Inc., Bethlehem, PA) were used as a comparator.RESULTS: The mean diameter at the middle of the 20, 22, 24, 26, and 28 mm TD balloon at nominal pressure (3 atm) was 20.02 ± 0.09, 21.77 ± 0.07, 23.9 ± 0.06, 25.82 ± 0.08, and 27.62 ± 0.08 mm, respectively. The maximal mean diameter at the middle of the 20, 22, 24, 26, and 28 mm TD balloon was 20.39 ± 0.03 mm (15 atm), 22.35 ± 0.03 mm (15 atm), 24.55 ± 0.02 mm (15 atm), 26.48 ± 0.02 mm (12 atm), and 28.39 ± 0.03 mm (12 atm), respectively. The 20/22/24 and 26/28 mm balloon failed when inflated beyond 15 atm and 12 atm, respectively. Failure was due to either leakage or longitudinal balloon rupture. TD balloons were more likely to maintain dimensions similar to their labeled size and less likely to fail at higher pressures as compared to Z-MED balloons.CONCLUSION: The TD balloon catheter maintains a similar diameter to its labeled size, when inflated beyond its RBP. When inflated beyond 12 atm, the TD balloon can fail due to either leakage or rupture. This has implications for percutaneous structural heart interventions.

AIMS: The commonly used valve-in-valve (VIV) app recommends sizing based on dimensions of both the transcatheter heart valve (THV) and bioprosthetic surgical valve. The implications of hydrodynamic testing to guide VIV sizing are poorly understood. This bench study assessed the hydrodynamic performance of different sizes of self-expanding supra-annular THVs in three different surgical aortic bioprostheses at different implantation depths.METHODS: A small versus medium ACURATE neo (ACn), and a 26 mm versus 29 mm Evolut R were assessed after VIV implantation in 25 mm Mitroflow, Mosaic, and Magna Ease aortic surgical bioprostheses, at three implantation depths (+2 mm, -2 mm, and -6 mm).RESULTS: The medium-sized ACn had lower gradients compared to the small ACn when the THV was implanted high (+2 mm, or -2 mm). The 29 mm Evolut R had lower gradients compared to a 26 mm Evolut R for all implantation depths, except for a depth of -2 mm in the 25 mm Mitroflow. The medium ACn and 29 mm Evolut R had larger effective orifice areas compared to the small ACn and 26 mm Evolut R, respectively. Both Evolut R sizes had acceptable regurgitant fractions (<15%), while both ACn sizes were above the acceptable performance criteria (>15%), at all implantation depths.CONCLUSIONS: Use of a larger self-expanding THV was associated with superior hydrodynamic performance if the THV was implanted high. Hydrodynamic testing can provide additional information to the VIV app to help guide VIV sizing.

Aims: We aimed to assess the impact of implant depth on hydrodynamic function following valve-in-valve (VIV) intervention using the ALLEGRA transcatheter heart valve (THV) in three different surgical valve designs. Methods and results: Multiple implantation depths (+2 mm, -2 mm and -6 mm) were tested using a 23 mm ALLEGRA THV for VIV intervention in 19 mm, 21 mm, 23 mm, and 25 mm Epic, Mitroflow and Magna Ease bioprosthetic valves. Multimodality imaging and hydrodynamic evaluation was performed at each implantation depth. The 23 mm ALLEGRA valve had gradients <20 mmHg in the Mitroflow and Epic valves sized ≥21 mm, and in all sizes of the Magna Ease valve. Gradients did not increase significantly at lower implantation depths. The 19 mm Epic (+2 mm: 20.1±0.6 mmHg, -2 mm: 18.8±0.5 mmHg, -6 mm: 22.8±0.3 mmHg) and 19 mm Mitroflow (+2 mm: 24.1±0.2 mmHg, -2 mm: 31.5±0.3 mmHg, -6 mm: 25.6±0.2 mmHg) valves had elevated mean gradients. In larger sized surgical valves (≥23 mm) the regurgitant fraction was higher at low implantation depths. Pinwheeling was significantly worse in the smaller sized (≤21 mm) surgical valves and also at low (<-2 mm) implantation depth. Conclusions: The 23 mm ALLEGRA valve had favourable (<20 mmHg) gradients in all surgical valves sized ≥21 mm, even when the THV was implanted low. In 19 mm sized Mitroflow and Epic valves, gradients were elevated (>20 mmHg). While there was no major difference in mean transvalvular gradients, leaflet pinwheeling was worse at lower implantation depths.