QuestionIn patients at increased risk of pulmonary complications undergoing cardiac surgery, does prophylactic high-flow nasal oxygen therapy (HFNOT) initiated at the time of extubation have important clinical benefits vs the use of standard oxygen therapy (SOT)?FindingsIn this randomized clinical trial that included 1280 adults, HFNOT did not improve clinical outcomes compared with SOT.MeaningThese findings do not support the routine implementation of prophylactic HFNOT for noninvasive respiratory support following cardiac surgery. This randomized clinical trial investigates the use of high-flow nasal oxygen therapy in patients at high risk of pulmonary complications following nonemergent cardiac surgery and assesses the clinical benefits of this technique compared with standard oxygen therapy. ImportanceHigh-flow nasal oxygen therapy (HFNOT) is used for noninvasive respiratory support following cardiac surgery despite uncertainty about its clinical effectiveness or associated costs.ObjectiveTo determine whether prophylactic HFNOT in patients at increased risk of respiratory complications following cardiac surgery has clinical benefits compared with standard oxygen therapy (SOT).Design, Setting, and ParticipantsThis adaptive, parallel group, randomized clinical trial collected and analyzed data from 17 cardiac surgery centers in 3 countries between October 7, 2020, and June 19, 2024. Eligible participants included adults undergoing nonemergent cardiac surgery with any of the following risk factors for pulmonary complications: chronic obstructive pulmonary disease, asthma, lower respiratory tract infection in the last 4 weeks, a body mass index of 35 or greater, or currently or recently smoking for longer than 10 pack-years. Outcome assessors were blinded. A preplanned sample size re-estimation was conducted after 300 participants completed the 90-day follow-up.InterventionParticipants were randomized at a 1:1 ratio with concealed allocation to HFNOT or SOT administered for at least 16 hours immediately after postoperative extubation.Main Outcomes and MeasuresThe primary effectiveness outcome was days alive and at home (DAH) without increased support compared with baseline in the first 90 days (DAH90). Any day of increased support, including at home, would provide a value of 0 for that day. Secondary outcomes included DAH90 without considering the additional support component.ResultsA total of 1280 patients were recruited (mean [SD] age, 62.9 [10.5] years; 892 [69.7%] men; 640 in each group), of whom 1224 (95.6%) had complete DAH90 data. The primary outcome of median DAH90 was 0 (IQR, 0-79) for the HFNOT group and 0 (IQR, 0-87) for the SOT group (median difference, 0 [95% CI, 0-0]; P = .75). Secondary clinical outcomes, including DAH90 without considering whether additional support was required, were similar between groups.Conclusions and RelevanceIn this randomized clinical trial of HFNOT in patients at increased risk of postoperative pulmonary complications after nonemergent cardiac surgery, HFNOT did not improve DAH90 without increased support. These findings do not support the implementation of routine prophylactic HFNOT after cardiac surgery.Trial Registrationisrctn.org Identifier: ISRCTN14092678
Three-dimensional (3D) mesh reconstruction of the cardiac anatomy from medical images is useful for shape and motion measurements and biophysics simulations. However, 3D medical images are often acquired as 2D slices that are sparsely sampled (e.g., large slice spacing) and noisy, and 3D mesh reconstruction on such data is a challenging task. Traditional voxel-based approaches utilize non-differentiable pre- and post-processing that compromises fidelity to images, while mesh-level deep learning approaches require large 3D mesh annotations that are difficult to obtain. Differentiable cross-domain supervision from 2D images to 3D meshes is therefore crucial for enabling end-to-end optimization in medical imaging. While there have been attempts to approximate the voxelization and slicing of meshes that are being optimized, there has not yet been a method for directly using 2D slices to supervise 3D mesh reconstruction in a differentiable manner. Here, we propose a novel explicit differentiable voxelization and slicing (DVS) algorithm allowing gradient backpropagation to a 3D mesh from its slices, which facilitates refined mesh optimization directly supervised by the losses defined on 2D images. Further, we propose an innovative framework for extracting patient-specific left ventricle (LV) meshes from medical images by coupling DVS with a graph harmonic deformation (GHD) mesh morphing descriptor of cardiac shape that naturally preserves mesh quality and smoothness during optimization. The proposed framework achieves state-of-the-art performance in cardiac mesh reconstruction tasks from densely sampled (CT) as well as sparsely sampled (MRI stack with few slices) images, outperforming alternatives, including Marching Cubes, statistical shape models, algorithms with vertex-based mesh morphing algorithms and alternative methods for image-supervision of mesh reconstruction. Experimental results demonstrate that our method achieves an overall Dice score of 90% during a sparse fitting on multi-datasets. The proposed method can further quantify clinically useful parameters such as ejection fraction and global myocardial strains, closely matching the ground truth and outperforming the traditional voxel-based approach in sparse images.
RATIONALE:Interstitial lung abnormalities (ILAs) and emphysema are frequently detected during lung cancer screening (LCS), but the impact of their coexistence-termed combined ILA and emphysema (CILAE)-on lung cancer risk remains unclear. OBJECTIVES:To determine the prevalence of CILAE in a national LCS cohort, evaluate whether its effect on lung cancer risk is additive or multiplicative, and quantify its association with lung cancer incidence. METHODS:This retrospective cohort study analyzed data from the Korean national LCS program (2019-2020). Participants were categorized into 4 CT-defined groups: neither condition, emphysema alone, ILA alone, and CILAE. Lung cancer incidence rate ratios (IRRs) were calculated using the neither condition group as the reference. Cox proportional hazards regression, adjusted for demographic and clinical factors, assessed the interaction and risk associated with CILAE. RESULTS:Among 125 600 participants, CILAE was present in 1.0% (1223/125 600), ILA alone in 1.7% (2101/125 600), and emphysema alone in 12.8% (16 077/125 600). Over a median follow-up of 2.8 years (95% confidence interval [CI], 2.8-2.9 years), lung cancer was diagnosed in 1.4% (1709/125 600). Compared to neither condition, IRRs for lung cancer were 9.12 (95% CI, 7.39-11.0) for CILAE, 4.51 (95% CI, 3.63-5.44) for ILA alone, and 2.93 (95% CI, 2.66-3.20) for emphysema alone. Adjusted hazard ratios [HRs] for lung cancer were 5.17 (95% CI, 4.21-6.35; P < .001) for CILAE, 3.10 (95% CI, 2.50-3.84; P < .001) for ILA alone, and 2.05 (95% CI, 1.83-2.30; P < .001) for emphysema alone. The interaction term between ILA and emphysema was not significant (adjusted HR, 0.81 [95% CI, 0.60-1.10]; P = .17), suggesting an additive rather than multiplicative effect. CONCLUSIONS:CILAE was present in 1% of LCS participants and was associated with a lung cancer risk exceeding that of ILA or emphysema alone. The combined effect was additive rather than synergistic.
OBJECTIVES:Nintedanib slows progression of systemic sclerosis-associated interstitial lung disease (SSc-ILD), but its tolerability in this patient group is a potential concern. METHODS:This multicentre study evaluated tolerability and treatment-related interruptions in SSc-ILD patients receiving nintedanib. Factors associated with interruption were analysed by logistic regression, with multivariable adjustment for potential confounders. Fisher's exact test was used when complete separation precluded logistic regression. Cox regression assessed time to first interruption. Weight changes before and after treatment were compared using the Wilcoxon signed-rank test. RESULTS:Among 63 patients (mean age 56.5±13.8 years, 22% male), 76% received nintedanib 150 mg twice daily, the remainder 100 mg twice daily; 86% were on mycophenolate. Over a median 22.2-month follow-up (95% CI 18.1-26.2), 51% experienced nintedanib interruptions. Patient-reported reasons for treatment interruption included diarrhoea (33.3%), nausea/vomiting (20.6%), weight loss (9.5%) and reflux (1.6%). Older age (p< 0.03) and BMI <18.5 kg/m2 (p=0.024) were independently associated with interruption. BMI <18.5 kg/m2 was also independently linked to shorter time to interruption. Permanent discontinuation occurred in 20.6%, with no significant predictors identified. Weight loss in the 12±6 months after treatment initiation (mean 2.05 kg) was significantly greater than in the preceding 12±6 months (1.09 kg) (p=0.001). CONCLUSIONS:Adverse effects frequently led to treatment interruptions in SSc-ILD patients. Older age and lower BMI were predictors of interruption, while no clear predictors of permanent discontinuation were identified. Most patients resumed treatment, highlighting the need for close monitoring and supportive care to manage side effects and maintain treatment continuity.
