Real-world Clinical Impact Research Articles

Real-world clinical impact of external elastic lamina-based stent sizing criteria using optical coherence tomography

Abstract Introduction ILUMIEN III trial has reported that non-inferiority of optical coherence tomography (OCT)-guided percutaneous coronary intervention (PCI) to intravascular ultrasound-guided PCI for postprocedural minimum stent area. In the trial, external elastic lamina (EEL)-based stent sizing criteria was introduced, however OCT has limitations including incomplete visualization of EEL in severale lesions. Purpose The aim of the study is to investigate real-world clinical impact of EEL-based stent sizing criteria. Methods The study included consecutive patients who underwent OCT-guided percutaneous coronary intervention (PCI) for de novo lesions in our institution between September 2016 and April 2018. EEL visibility, mean EEL diameter, mean lumen diameter and plaque morphology were assessed at proximal and distal references. The plaque morphology at references was categorized according to its most prevalent component as follows: normal, fibrous plaque, lipid plaque, and calcified plaque. Both references were divided into 3 groups according to visibility of EEL. Results Among 205 lesions, 31 lesions had artifacts at references (16 proximal and 17 distal references). EEL visibility was summarized in a table. Out of 174 lesions with both analyzable references, 111 lesions (63.8%) had >180-degree EEL visibility at both references. Proportion of plaque morphology were significantly different among 3 groups at proximal and distal references as shown in a figure. Conclusions EEL-based stent sizing criteria was usable for 63.8% of all the lesions. Vessel size and plaque morphology were significantly associated with EEL visibility. Proportion of plaque morphology Funding Acknowledgement Type of funding source: None

Clinical Impact of Metagenomic Next-Generation Sequencing of Plasma Cell-Free DNA for the Diagnosis of Infectious Diseases: A Multicenter Retrospective Cohort Study.

Metagenomic next-generation sequencing (mNGS) of plasma cell-free DNA has emerged as an attractive diagnostic modality allowing broad-range pathogen detection, noninvasive sampling, and earlier diagnosis. However, little is known about its real-world clinical impact as used in routine practice. We performed a retrospective cohort study of all patients for whom plasma mNGS (Karius test) was performed for all indications at 5 United States institutions over 1.5 years. Comprehensive records review was performed, and standardized assessment of clinical impact of the mNGS based on the treating team's interpretation of Karius results and patient management was established. A total of 82 Karius tests were evaluated from 39 (47.6%) adults and 43 (52.4%) children and a total of 53 (64.6%) immunocompromised patients. Karius positivity rate was 50 of 82 (61.0%), with 25 (50.0%) showing 2 or more organisms (range, 2-8). The Karius test results led to positive impact in 6 (7.3%), negative impact in 3 (3.7%), and no impact in 71 (86.6%), and was indeterminate in 2 (2.4%). Cases with positive Karius result and clinical impact involved bacteria and/or fungi but not DNA viruses or parasites. In 10 patients who underwent 16 additional repeated tests, only 1 was associated with clinical impact. The real-world impact of the Karius test as currently used in routine clinical practice is limited. Further studies are needed to identify high-yield patient populations, define the complementary role of mNGS to conventional microbiological methods, and discern how best to integrate mNGS into current testing algorithms.

Real-World Clinical Impact of Immune Checkpoint Inhibitors in Patients With Advanced/Metastatic Non–Small Cell Lung Cancer After Platinum Chemotherapy

BackgroundThe real-world effect of anti-programmed death ligand 1 (PD-L1) therapies is unclear. We compared US patients who received second-line therapy for non–small-cell lung cancer (NSCLC) before and shortly after US Food and Drug Administration (FDA) approval of PD-L1 inhibitors. Patients and MethodsPatients in the Flatiron Health database (≥18 years; received first-line platinum therapy for advanced/metastatic NSCLC; ≥6 months of follow-up) were assessed before (“historical”: January 1, 2011 to December 31, 2013) and after (“current”: January 1, 2015 to May 31, 2017) FDA approval of anti–PD-L1 therapies for NSCLC. Index was start of second-line therapy. Baseline variables, treatment patterns, and overall survival (OS) were reported. ResultsA greater proportion of patients in the current cohort received second-line treatment than in the historical cohort (n = 4240 [57.0%] vs. n = 2357 [37.4%]); 48.8% [n = 2071] of the current second-line patients received anti–PD-L1 therapy. Current patients were more likely to receive second-line anti–PD-L1 therapy if they had poorer Eastern Cooperative Oncology Group (ECOG) performance status (≥2), had squamous histology, or had no epidermal growth factor receptor (EGFR), anaplastic lymphoma kinase (ALK), or ROS proto-oncogene 1 mutations. Median OS from index was higher in the current cohort (9.4 [95% confidence interval (CI), 8.9-9.9] months) than the historical cohort (7.3 [95% CI, 6.9-7.8] months). Adjusted for sex, race, ECOG performance status, disease stage, and Kirsten rat sarcoma viral oncogene homolog, EGFR, and ALK status, OS was improved by 15% in the current cohort. ConclusionContemporary patients are more likely to receive second-line therapy and have longer OS than patients who received care before approval of anti–PD-L1 therapies.

Clinical impact of FFRct-guided care in the National Health Service District General Hospital setting

Introduction: Coronary computed tomography angiography (CCTA) with CCTA-derived fractional flow reserve (FFRct) real-world clinical impact has recently been described across multiple International tertiary centers but has not previously been described in the District General hospital setting in the National Health Service (NHS). Furthermore, the impact of FFRct-guided management of time to next investigation / definitive treatment has not been assessed either. We aim to re-address these issues in a prospective single-center observational study.