Recent Publications by CFE Educators

Importance

The Centers for Medicare & Medicaid Services national coverage determination for transcatheter aortic valve replacement (TAVR) includes volume requirements for surgical aortic valve replacement (SAVR) for hospitals seeking to initiate or continue TAVR programs. Evidence regarding the association between SAVR volume and TAVR outcomes is limited.

Objective

To examine the association of hospital SAVR and combined SAVR and TAVR volumes with patient outcomes of TAVR procedures performed within 1 year, 2 years, and for the entire period after initiation of TAVR programs.

Design, Setting, and Participants

This observational cohort study included 60 538 TAVR procedures performed in 438 hospitals between October 1, 2011, and December 31, 2015, among Medicare beneficiaries.

Main Outcomes and Measures

The associations between SAVR volume, SAVR and TAVR volumes, and risks of death, death or stroke, and readmissions within 30 days were determined using a hierarchical logistic regression model adjusting for patient and hospital characteristics. The association between SAVR and SAVR and TAVR volumes and 1-year and 2-year mortality after TAVR procedures was determined using a multivariable proportional hazard model with a robust variance estimator. The associations for procedures performed within 1 year, 2 years, and for the entire period after initiation of TAVR programs were examined.

Results

Among the 60 538 patients, 29 173 were women and 31 365 were men, with a mean (SD) age of 82.3 (8.0) years. Hospitals with high SAVR volume (mean annual volume, ≥97 per year) were more likely to adopt TAVR early and had a higher growth in TAVR volumes over time (median TAVR volume by hospitals with high SAVR volume and low SAVR volume: year 1, 32 vs 19; year 2, 48 vs 28; year 3, 82 vs 38; year 4, 118 vs 54; P  .001). In adjusted analysis, high hospital SAVR volume alone was not associated with better patient outcomes after TAVR. When hospital TAVR and SAVR volumes were jointly analyzed, patients treated in hospitals with high TAVR volume had lower 30-day mortality after TAVR (high TAVR and low SAVR vs low TAVR and low SAVR: odds ratio, 0.85; 95% CI, 0.72-0.99; high TAVR and high SAVR vs low TAVR and high SAVR: odds ratio, 0.81; 95% CI, 0.69-0.95), the effect of which was more pronounced when hospitals also had high SAVR volume. Patients treated in hospitals with high SAVR volume and high TAVR volume had the lowest 30-day mortality (vs hospitals with low SAVR volume and TAVR volume: odds ratio, 0.77; 95% CI, 0.66-0.89).

Conclusions and Relevance

Hospitals with high SAVR volume are most likely to be fast adopters of TAVR. Hospital SAVR volume alone is not associated with better TAVR outcomes. Accumulating high volumes of TAVR is associated with lower mortality after TAVR, particularly when hospitals have high SAVR volumes. Hospitals with high caseloads of both SAVR and TAVR are likely to achieve the best outcomes.

BACKGROUND

The optimal dose of neoadjuvant radiation for locally advanced, resectable esophageal cancer remains controversial in the absence of randomized clinical trials, with conventional practice favoring the use of 50.4 vs. 41.4 Gy.

METHODS

Retrospective analysis of adults with non-metastatic esophageal cancer in the National Cancer Database (2004-2015) treated with neoadjuvant chemoradiotherapy. Outcomes were compared between patients undergoing 41.4, 45, or 50.4 Gy. Primary outcome was overall survival. Secondary outcomes included T and N downstaging and perioperative mortality adjusted for demographics, clinicopathologic factors, and facility volume.

RESULTS

Eight thousand eight hundred eighty-one patients were included: 439 (4.9%) received low-dose (41.4 Gy), 2194 (24.7%) received moderate-dose (45 Gy), and 6248 (70.4%) received high-dose (50.4 Gy) neoadjuvant radiation. Compared to high-dose, low-dose radiation was associated with superior median overall survival (52.6 vs. 40.7 months) and 5-year survival (48.3% vs. 40.2%), and lower unadjusted 90-day mortality (2.3% vs. 6.5%, all p ≤ 0.01). Multivariable proportional hazards models confirmed an increased hazard of death associated with high-dose radiation therapy (HR = 1.38, 95% CI 1.10-1.72, p = 0.005). There was no significant difference in T and/or N downstaging between low-dose vs. high-dose therapy (p > 0.1 for both). Patients receiving 45 Gy exhibited the lowest median overall survival (37.2 months) and 5-year survival (38.7%, log-rank p = 0.04).

CONCLUSIONS

Compared to 50.4 Gy, 41.4 Gy is associated with reduced perioperative mortality and superior overall survival with similar downstaging in locally advanced esophageal cancer. In the absence of randomized clinical data, our findings support the use of 41.4 Gy in patients with chemoradiation followed by esophagectomy. Prospective trials are warranted to further validate these results.

OBJECTIVE:

Lung tissue elasticity is an effective spatial representation for Chronic Obstructive Pulmonary Disease phenotypes and pathophysiology. We investigated a novel imaging biomarker based on the voxel-by-voxel distribution of lung tissue elasticity. Our approach combines imaging and biomechanical modeling to characterize tissue elasticity.

METHODS:

We acquired 4DCT images for 13 lung cancer patients with known COPD diagnoses based on GOLD 2017 criteria. Deformation vector fields (DVFs) from the deformable registration of end-inhalation and end-exhalation breathing phases were taken to be the ground-truth. A linear elastic biomechanical model was assembled from end-exhalation datasets with a density-guided initial elasticity distribution. The elasticity estimation was formulated as an iterative process, where the elasticity was optimized based on its ability to reconstruct the ground-truth. An imaging biomarker (denoted YM) derived from the optimized elasticity distribution, was compared with the current gold standard, RA using confusion matrix and area under the receiver operating characteristic (AUROC) curve analysis.

RESULTS:

The estimated elasticity had 90 % accuracy when representing the ground-truth DVFs. The YM biomarker had higher diagnostic accuracy (86% vs 71 %), higher sensitivity (0.875 vs 0.5), and a higher AUROC curve (0.917 vs 0.875) as compared to RA. Along with acting as an effective spatial indicator of lung pathophysiology, the YM biomarker also proved to be a better indicator for diagnostic purposes than RA.

CONCLUSIONS:

Overall, the results suggest that, as a biomarker, lung tissue elasticity will lead to new end points for clinical trials and new targeted treatment for COPD subgroups.

ADVANCES IN KNOWLEDGE:

The derivation of elasticity information directly from 4DCT imaging data is a novel method for performing lung elastography. The work demonstrates the need for a mechanics-based biomarker for representing lung pathophysiology.

The surgical oncologist of the future requires training in minimally invasive techniques. Increasing constraints on time and resources have led to a new emphasis on finding innovative ways to teach these surgical skills inside and outside the operating room. The goal of producing technically gifted minimally invasive surgical (MIS) oncologists requires robust, educationally sound training curricula. This article describes how MIS oncology training occurs at present with an outline of educational ideals training programs can strive for, provides two examples of successful MIS oncology programs to highlight effective strategies for moving forward, and introduces three new developments on the horizon.

BACKGROUND

At present, biological disease-modifying anti-rheumatic drugs (DMARDs) are the only treatment recommended for patients with ankylosing spondylitis who have not responded to first-line treatment with non-steroidal anti-inflammatory drugs (NSAIDs). The TORTUGA trial investigated the efficacy and safety of filgotinib, an oral selective Janus kinase 1 (JAK1) inhibitor, for the treatment of patients with active ankylosing spondylitis.

METHODS

In this completed, randomised, double-blind, placebo-controlled, phase 2 trial, we enrolled adult patients from 30 sites in seven countries (Belgium, Bulgaria, Czech Republic, Estonia, Poland, Spain, and Ukraine). Eligible patients had active ankylosing spondylitis and an inadequate response or intolerance to two or more NSAIDs. Patients were randomly assigned (1:1) with an interactive web-based response system to receive filgotinib 200 mg or placebo orally once daily for 12 weeks. Randomisation was stratified by current use of conventional synthetic DMARDs and previous receipt of anti-tumour necrosis factor therapy. The patients, study team, and study sponsor were masked to treatment assignment. The primary endpoint was the change from baseline in ankylosing spondylitis disease activity score (ASDAS) at week 12, which was assessed in the full analysis set (ie, all randomised patients who received at least one dose of study drug). Safety was assessed according to actual treatment received. This trial is registered with ClinicalTrials.gov, number NCT03117270.

FINDINGS

Between March 7, 2017, and July 2, 2018, 263 patients were screened and 116 randomly assigned to filgotinib (n=58) or placebo (n=58). 55 (95%) patients in the filgotinib group and 52 (90%) in the placebo group completed the study; three (5%) patients in the filgotinib group and six (10%) in the placebo group discontinued treatment. The mean ASDAS change from baseline to week 12 was -1·47 (SD 1·04) in the filgotinib group and -0·57 (0·82) in the placebo group, with a least squares mean difference between groups of -0·85 (95% CI -1·17 to -0·53; p0·0001). Treatment-emergent adverse events were reported in 18 patients in each group, the most common being nasopharyngitis (in two patients in the filgotinib group and in four patients in the placebo group). Treatment-emergent adverse events led to permanent treatment discontinuation in two patients (a case of grade 3 pneumonia in the filgotinib group and of high creatine kinase in the placebo group). No deaths were reported during the study.

INTERPRETATION

Filgotinib is efficacious and safe for the treatment of patients with active ankylosing spondylitis who have not responded to first-line pharmacological therapy with NSAIDs. Further investigation of filgotinib for ankylosing spondylitis is warranted.

FUNDING

Galapagos and Gilead Sciences.

Resident-led quality improvement (QI) is an important component of resident education yet sustainability of improvement and impact on resident education have rarely been explored. This study describes a resident-led intervention to improve nursing (RN)-provider (MD) communication at discharge-the Discharge Time-Out (DTO)- and explores its uptake and sustainability. One year later, residents were surveyed regarding QI self-efficacy and planned QI involvement. Baseline verbal RN-MD communication at discharge was rare. During DTO implementation, rates of structured communication averaged 56% (341/608) with several months >70%. During the monitoring phase, this fell to 45% and did not recover (833/1852). Participating residents reported increased QI self-efficacy ( .05) and increased likelihood of participating in future QI ( .05). The DTO increased RN-MD communication but was not sustained. Resident-led QI should explicitly address sustainability to achieve improvement and educational objectives. To foster resident education and avoid short-lived, low-impact projects, increased attention should be given to sustainability of resident-led QI.