Impact of Mediating and Confounding Variables on the Volume-Outcome Association in the Treatment of Pancreatic Cancer.

BACKGROUND: High-volume centers (HVC), academic centers (AC), and longer travel distances (TD) have been associated with improved outcomes for patients undergoing surgery for pancreatic adenocarcinoma (PAC). Effects of mediating variables on these associations remain undefined. The purpose of this study is to examine the direct effects of hospital volume, facility type, and travel distance on overall survival (OS) in patients undergoing surgery for PAC and characterize the indirect effects of patient-, disease-, and treatment-related mediating variables. PATIENTS AND METHODS: Using the National Cancer Database, patients with non-metastatic PAC who underwent resection were stratified by annual hospital volume (< 11, 11-19, and ≥ 20 cases/year), facility type (AC versus non-AC), and TD (≥ 40 versus < 40 miles). Associations with survival were evaluated using multiple regression models. Effects of mediating variables were assessed using mediation analysis. RESULTS: In total, 19,636 patients were included. Treatment at HVC or AC was associated with lower risk of death [hazard ratio (HR) 0.90, confidence interval (CI) 0.88-0.92; HR 0.89, CI 0.86-0.91, respectively]. TD did not impact OS. Patient-, disease-, and treatment-related variables explained 25.5% and 41.8% of the survival benefit attained from treatment at HVC and AC, reducing the survival benefit directly attributable to each variable to 4.9% and 6.4%, respectively. CONCLUSIONS: Treatment of PAC at HVC and AC was associated with improved OS, but the magnitude of this benefit was less when mediating variables were considered. From a healthcare utilization and cost-resource perspective, further research is needed to identify patients who would benefit most from selective referral to HVC or AC.

Impact of Adherence to Operative Standards and Stage-Specific Guideline-Recommended Therapy in Nonmetastatic Pancreatic Adenocarcinoma.

BACKGROUND: Achieving optimal surgical outcomes in pancreatic adenocarcinoma requires a combination of both curative-intent resection to oncologic standards and stage-specific neoadjuvant or adjuvant therapy. This investigation sought to examine factors associated with receipt of standard-adherent surgery (SAS) and guideline-recommended therapy (GRT) and determine the impact of compliance on patient survival. PATIENTS AND METHODS: From the 2006-2016 National Cancer Database, 21,304 patients underwent resection for nonmetastatic pancreatic adenocarcinoma. SAS was defined as pancreatic resection with negative margins and ≥ 15 lymph nodes examined. Stage-specific GRT was defined by current National Comprehensive Cancer Network guidelines. Multivariable models were used to determine predictors of adherence to SAS and GRT and prognostic impact on overall survival. RESULTS: Overall, SAS was achieved in 39% and GRT in 65% of patients, but only 30% received both SAS and GRT. Increasing age, minority race, uninsured status, and greater comorbidities were associated with a decreased odds of receiving both SAS and GRT (all p < 0.05). SAS (HR 0.79; CI 0.76-0.81; p < 0.001) and GRT (HR 0.67; CI 0.65-0.69; p < 0.001) were each independently associated with a survival advantage. Receipt of both SAS and GRT was associated with significant improvement in median OS compared with receiving neither (2.2 years vs 1.1 years; p < 0.001) which was independently associated with a 78% increased risk of death (HR 1.78; CI 1.70-1.86; p < 0.001). CONCLUSIONS: Despite survival benefits associated with adherence to operative standards and receipt of guideline-recommended therapy, compliance remains poor. Future efforts must be directed toward improved education and implementation efforts around both operative standards and therapy guidelines.

Remdesivir and Mortality in Patients With Coronavirus Disease 2019.

BACKGROUND: The impact of remdesivir (RDV) on mortality rates in coronavirus disease 2019 (COVID-19) is controversial, and the mortality effect in subgroups of baseline disease severity has been incompletely explored. The purpose of this study was to assess the association of RDV with mortality rates in patients with COVID-19. METHODS: In this retrospective cohort study we compared persons receiving RDV with those receiving best supportive care (BSC). Patients hospitalized between 28 February and 28 May 2020 with laboratory-confirmed severe acute respiratory syndrome coronavirus 2 infection were included with the development of COVID-19 pneumonia on chest radiography and hypoxia requiring supplemental oxygen or oxygen saturation ≤94% with room air. The primary outcome was overall survival, assessed with time-dependent Cox proportional hazards regression and multivariable adjustment, including calendar time, baseline patient characteristics, corticosteroid use, and random effects for hospital. RESULTS: A total of 1138 patients were enrolled, including 286 who received RDV and 852 treated with BSC, 400 of whom received hydroxychloroquine. Corticosteroids were used in 20.4% of the cohort (12.6% in RDV and 23% in BSC). Comparing persons receiving RDV with those receiving BSC, the hazard ratio (95% confidence interval) for death was 0.46 (.31-.69) in the univariate model (P < .001) and 0.60 (.40-.90) in the risk-adjusted model (P = .01). In the subgroup of persons with baseline use of low-flow oxygen, the hazard ratio (95% confidence interval) for death in RDV compared with BSC was 0.63 (.39-1.00; P = .049). CONCLUSION: Treatment with RDV was associated with lower mortality rates than BSC. These findings remain the same in the subgroup with baseline use of low-flow oxygen.

Clinical Factors and Outcomes When Real-World Heart Teams Overruled STS Risk Scores in TAVR Cases.

Objectives: This study was conducted to determine why heart teams recommended transcatheter aortic valve replacement (TAVR) versus surgical AVR (SAVR) for patients at low predicted risk of mortality (PROM) and describe outcomes of these cases. Background: Historically, referral to TAVR was based predominately on the Society of Thoracic Surgeons (STS) risk model's PROM >3%. In selected cases, heart teams had latitude to overrule these scores. The clinical reasons and outcomes for these cases are unclear. Methods: Retrospective data were gathered for all TAVR and SAVR cases conducted by 9 hospitals between 2013 and 2017. Results: Cases included TAVR patients with STS PROM >3% (n = 2,711) and ≤3% (n = 415) and SAVR with STS PROM ≤3% (n = 1,438). Leading reasons for recommending TAVR in the PROM ≤3% group were frailty (57%), hostile chest (22%), severe lung disease (16%), and morbid obesity (13%), and 44% of cases had multiple reasons. Most postoperative and 30-day outcomes were similar between TAVR groups, but the STS PROM ≤3% group had a one-day shorter length of stay (2.5 ± 3.4 vs. 3.5 ± 4.7 days; p ≤ 0.001) and higher one-year survival (91.6% vs. 86.0%, p=0.002). In patients with STS PROM ≤3%, 30-day mortality was higher for TAVR versus SAVR (2.0% vs. 0.6%; p < 0.001). Conclusions: Heart teams recommended TAVR in patients with STS PROM ≤3% primarily due to frailty, hostile chest, severe lung disease, and/or morbid obesity. Similar postoperative outcomes between these patients and those with STS PROM >3% suggest that decisions to overrule STS PROM ≤3% were merited and may have reduced SAVR 30-day mortality rate.

Preoperative Risk Prediction for Pancreatectomy: A Comparative Analysis of Three Scoring Systems.

INTRODUCTION: Pancreatectomy is associated with high morbidity and mortality. Therefore, patient selection and risk prediction is paramount. In this study, three validated perioperative risk scoring systems were compared among patients undergoing pancreatectomy to identify the most clinically useful model. MATERIALS AND METHODS: The 2014-2017 American College of Surgeons National Surgical Quality Improvement Program database was queried for pancreatectomy patients. Three models were evaluated: National Surgical Quality Improvement Program Universal Risk Calculator (URC), Model for End-Stage Liver Disease (MELD), and Modified Frailty Index-5 Factor (mFI-5). Outcomes were 30-d mortality and complications. Predictive performance of the models was compared using area under the receiver operating characteristic curve (AUC) and Brier scores. RESULTS: Twenty two thousand one hundred twenty three pancreatectomy patients were identified. The 30-d mortality rate was 1.4% (n = 319). Complications occurred in 6020 cases (27.2%). AUC (95% CI) for 30-d mortality were 0.70 (0.67-0.73), 0.63 (0.60-0.67), and 0.60 (0.57-0.63) for URC, MELD, and mFI-5, respectively, with Brier score of 0.014 for all three models. AUC (95% confidence interval) for any complication was 0.59 (0.58-0.59) for URC, 0.53 (0.52-0.54) for MELD, and 0.53 (0.52-0.54) for mFI-5, with Brier scores 0.193 (URC), 0.200 (MELD), and 0.197 (mFI-5). For individual complications, URC was more predictive than MELD or mFI-5. CONCLUSIONS: Of the validated preoperative risk scoring systems, URC was most predictive of both complications and 30-d mortality. None of the models performed better than fair to good. The lack of predictive accuracy of currently existing models highlights the need for development of improved perioperative risk models.

Multiplex immunofluorescence to measure dynamic changes in tumor-infiltrating lymphocytes and PD-L1 in early-stage breast cancer.

BACKGROUND: The H&E stromal tumor-infiltrating lymphocyte (sTIL) score and programmed death ligand 1 (PD-L1) SP142 immunohistochemistry assay are prognostic and predictive in early-stage breast cancer, but are operator-dependent and may have insufficient precision to characterize dynamic changes in sTILs/PD-L1 in the context of clinical research. We illustrate how multiplex immunofluorescence (mIF) combined with statistical modeling can be used to precisely estimate dynamic changes in sTIL score, PD-L1 expression, and other immune variables from a single paraffin-embedded slide, thus enabling comprehensive characterization of activity of novel immunotherapy agents. METHODS: Serial tissue was obtained from a recent clinical trial evaluating loco-regional cytokine delivery as a strategy to promote immune cell infiltration and activation in breast tumors. Pre-treatment biopsies and post-treatment tumor resections were analyzed by mIF (PerkinElmer Vectra) using an antibody panel that characterized tumor cells (cytokeratin-positive), immune cells (CD3, CD8, CD163, FoxP3), and PD-L1 expression. mIF estimates of sTIL score and PD-L1 expression were compared to the H&E/SP142 clinical assays. Hierarchical linear modeling was utilized to compare pre- and post-treatment immune cell expression, account for correlation of time-dependent measurement, variation across high-powered magnification views within each subject, and variation between subjects. Simulation methods (Monte Carlo, bootstrapping) were used to evaluate the impact of model and tissue sample size on statistical power. RESULTS: mIF estimates of sTIL and PD-L1 expression were strongly correlated with their respective clinical assays (p < .001). Hierarchical linear modeling resulted in more precise estimates of treatment-related increases in sTIL, PD-L1, and other metrics such as CD8+ tumor nest infiltration. Statistical precision was dependent on adequate tissue sampling, with at least 15 high-powered fields recommended per specimen. Compared to conventional t-testing of means, hierarchical linear modeling was associated with substantial reductions in enrollment size required (n = 25➔n = 13) to detect the observed increases in sTIL/PD-L1. CONCLUSION: mIF is useful for quantifying treatment-related dynamic changes in sTILs/PD-L1 and is concordant with clinical assays, but with greater precision. Hierarchical linear modeling can mitigate the effects of intratumoral heterogeneity on immune cell count estimations, allowing for more efficient detection of treatment-related pharmocodynamic effects in the context of clinical trials. TRIAL REGISTRATION: NCT02950259 .

Is the 21-Gene Recurrence Score on Core Needle Biopsy Equivalent to Surgical Specimen in Early-Stage Breast Cancer? A Comparison of Gene Expression Between Paired Core Needle Biopsy and Surgical Specimens.

BACKGROUND: Molecular testing on surgical specimens predicts disease recurrence and benefit of adjuvant chemotherapy in hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) early-stage breast cancer (EBC). Testing on core biopsies has become common practice despite limited evidence of concordance between core/surgical samples. In this study, we compared the gene expression of the 21 genes and the recurrence score (RS) between paired core/surgical specimens. METHODS: Eighty patients with HR+/HER2- EBC were evaluated from two publicly available gene expression datasets (GSE73235, GSE76728) with paired core/surgical specimens without neoadjuvant systemic therapy. The expression of the 21 genes was compared in paired samples. A microarray-based RS was calculated and a value ≥ 26 was defined as high-RS. The concordance rate and kappa statistic were used to evaluate the agreement between the RS of paired samples. RESULTS: Overall, there was no significant difference and a high correlation in the gene expression levels of the 21 genes between paired samples. However, CD68 and RPLP0 in GSE73235, AURKA, BAG1, and TFRC in GSE76728, and MYLBL2 and ACTB in both datasets exhibited weak to moderate correlation (r < 0.5). There was a high correlation of the microarray-based RS between paired samples in GSE76728 (r = 0.91, 95% confidence interval [CI] 0.81-0.96) and GSE73235 (r = 0.82, 95% CI 0.71-0.89). There were no changes in RS category in GSE76728, whereas 82% of patients remained in the same RS category in GSE73235 (κ = 0.64). CONCLUSIONS: Gene expression levels of the 21-gene RS showed a high correlation between paired specimens. Potential sampling and biological variability on a set of genes need to be considered to better estimate the RS from core needle biopsy.

Resectable Distal Pancreas Cancer: Time to Reconsider the Role of Upfront Surgery.

BACKGROUND: Neoadjuvant chemotherapy (NAC) is increasingly utilized to optimize survival in proximal pancreatic adenocarcinoma. However, few studies have explored the impact of NAC in distal pancreas cancer. METHODS: Patients with resectable pancreatic adenocarcinoma of the body or tail treated with either upfront pancreatectomy or NAC followed by surgery were identified in the 2006-2014 National Cancer Database. Trends in utilization, predictors of use, and impact of NAC on overall survival were determined. RESULTS: Of 1485 patients, 176 (11.9%) received NAC. Use of NAC increased from 9.3% in 2006 to 16.9% in 2013 [odds ratio 1.14; 95% confidence interval (CI) 1.05-1.24; p = 0.001]. NAC patients were younger, had higher clinical stage, and preoperative CA 19-9 levels (all p < 0.05). After adjustment for patient-, tumor-, and treatment-related factors, increased clinical stage was the greatest independent predictor of neoadjuvant approach (p < 0.001). On multivariable analysis, survival benefit from NAC did not reach threshold of significance (95% CI 0.66-1.04; p = 0.10) for the entire cohort. However, NAC was associated with a significant survival advantage in clinical stage III with a 51% decreased yearly risk of death (adjusted hazard ratio 0.49; 95% CI 0.25-0.98; p = 0.04). A trend towards improved survival with NAC was observed among stage IIA (p = 0.09) and IIB (p = 0.07) patients. CONCLUSIONS: Neoadjuvant chemotherapy is associated with improved overall survival in Stage III distal pancreatic adenocarcinoma and shows promise in earlier stage disease. However, only a small percentage of patients receive NAC. Prospective evaluation of NAC in distal pancreatic adenocarcinoma is warranted based on these findings.

Surveillance of guideline practices for duodenoscope and linear echoendoscope reprocessing in a large healthcare system.

BACKGROUND AND AIMS: To assess the adequacy of currently recommended duodenoscope and linear echoendoscope (DLE) automatic endoscope reprocessing (AER) and high-level disinfection (HLD), we collected daily post-reprocessing surveillance cultures of 106 DLEs in 21 Providence and Affiliate Hospitals. METHODS: Daily qualitative surveillance of dried, post-HLD DLEs was conducted for a minimum of 30 days at each facility. Positivity rates for any microbial growth and growth of high-concern pathogens were reported. Potential effects of DLE manufacturer, age, and AER processor on culture-positivity rate were assessed. RESULTS: Microbial growth was recovered from 201 of 4032 specimens (5%) or 189 of 2238 encounters (8.4%), including 23 specimens (.6%) or 21 encounters (.9%) for a high-concern pathogen. Wide variations in culture-positivity rate were observed across facilities. No striking difference in culture-positivity rate was seen among 8 DLE models, 3 DLE manufacturers, DLE age, manual or bedside cleanser, or automatic flushing system use. However, there was suggestive evidence that Custom Ultrasonics AER (Warminster, Pa, USA) had a lower culture-positivity rate than Medivators AER (Cantel Medical Corp., Little Falls, NJ, USA) for high-concern pathogen growth (0/1079 vs 21/2735 specimens or 0/547 vs 20/1582 encounters). Two endoscopes grew intestinal flora on several occasions despite multiple HLD. No multidrug-resistant organism was detected. CONCLUSIONS: In this multicenter DLE surveillance study, microbial growth was recovered in 5.0% of specimens (8.4% of encounters), with most being environmental microbes. Enteric bacterial flora was recovered in .6% of specimens (.9% of encounters), despite compliance with 2014 U.S. guidelines and manufacturers' recommendations for cleaning and HLD process. The observed better performance of Custom Ultrasonics AER deserves further investigation.

Modular versus nonmodular neck femoral implants in primary total hip arthroplasty: which is better?

BACKGROUND: Restoration of the hip center is considered important for a successful THA and requires achieving the right combination of offset, anteversion, and limb length. Modular femoral neck designs were introduced to make achieving this combination easier. No previous studies have compared these designs in primary THA, and there is increasing concern that modular designs may have a higher complication rate than their nonmodular counterparts. QUESTIONS/PURPOSES: We therefore asked (1) whether use of a stem with a modular neck would restore limb length and offset more accurately than a stem with a nonmodular neck, and (2) whether patients who received modular neck systems had better hip scores or a lower frequency of complications and reoperations than those receiving a comparable nonmodular stem. METHODS: Two cohorts of patients undergoing primary THAs, 284 patients with a nonmodular neck and 594 patients with a modular neck, were treated by one surgeon through a posterior approach. These were two nearly sequential series with little overlap. Harris hip scores and SF-12 outcomes surveys were administered at followup with a mean of 2.4 years (maximum, 5.9 years). RESULTS: In the modular neck cohort, a greater proportion of patients had equal (within 5 mm) radiographic limb lengths (89%, compared with 77% in nonmodular cohort p = 0.036), and a smaller offset difference (6.1 versus 7.5 mm, p = 0.047) was observed. Whether these statistical differences are clinically important is unclear. A smaller proportion of patients in the modular neck cohort achieved equal apparent or clinical limb length at 1 year (85% versus 95%, p < 0.001) and at 2 years (81% versus 94%, p < 0.001). In addition, these differences did not appear to result in better Harris hip or SF-12 scores, fewer complications, or reduced likelihood of revision surgery. CONCLUSIONS: Use of modular neck stems did not improve hip scores nor reduce the likelihood of complications or reoperations. Because of their reported higher risks, there is no clear indication for modularity with a primary THA, unless the hip center cannot be achieved with a nonmodular stem, which is rare. LEVEL OF EVIDENCE: Level III, therapeutic study. See the Instructions to Authors for a complete description of levels of evidence.

A simplified pneumonia severity index (PSI) for clinical outcome prediction in COVID-19.

BACKGROUND: The Pneumonia Score Index (PSI) was developed to estimate the risk of dying within 30 days of presentation for community-acquired pneumonia patients and is a strong predictor of 30-day mortality after COVID-19. However, three of its required 20 variables (skilled nursing home, altered mental status and pleural effusion) are not discreetly available in the electronic medical record (EMR), resulting in manual chart review for these 3 factors. The goal of this study is to compare a simplified 17-factor version (PSI-17) to the original (denoted PSI-20) in terms of prediction of 30-day mortality in COVID-19. METHODS: In this retrospective cohort study, the hospitalized patients with confirmed SARS-CoV-2 infection between 2/28/20-5/28/20 were identified to compare the predictive performance between PSI-17 and PSI-20. Correlation was assessed between PSI-17 and PSI-20, and logistic regressions were performed for 30-day mortality. The predictive abilities were compared by discrimination, calibration, and overall performance. RESULTS: Based on 1,138 COVID-19 patients, the correlation between PSI-17 and PSI-20 was 0.95. Univariate logistic regression showed that PSI-17 had performance similar to PSI-20, based on AUC, ICI and Brier Score. After adjusting for confounding variables by multivariable logistic regression, PSI-17 and PSI-20 had AUCs (95% CI) of 0.85 (0.83-0.88) and 0.86 (0.84-0.89), respectively, indicating no significant difference in AUC at significance level of 0.05. CONCLUSION: PSI-17 and PSI-20 are equally effective predictors of 30-day mortality in terms of several performance metrics. PSI-17 can be obtained without the manual chart review, which allows for automated risk calculations within an EMR. PSI-17 can be easily obtained and may be a comparable alternative to PSI-20.

Defining "the elderly" undergoing major gastrointestinal resections: receiver operating characteristic analysis of a large ACS-NSQIP cohort.

OBJECTIVE: "The elderly" is an often used but poorly defined descriptor of surgical patients. Investigators have used varying subjectively determined age cutoffs to report outcomes in the elderly. We set out to use objective outcomes data to determine the "at-risk" elderly population. PATIENTS: 129,331 patients identified from the ACS-NSQIP database (2005-2010) undergoing major gastrointestinal resections. OUTCOME: Mortality. STATISTICAL METHODS: Locally weighted regression was used to fit the trend line of mortality over age. Receiver operating characteristic analysis was used to identify the "predictive age" for mortality. RESULTS: Mortality steadily increases with age. On receiver operating characteristic analysis, there is a nonlinear transition zone (50-75 years of age) flanked by 2 linear zones on either end. The younger linear zone showed a low mortality increase (0.5% per decade). Larger mortality increase with age (5.3% per decade) was observed at the older age end. Similar patterns were observed for large-volume surgical subtypes, with clustering of a "critical age" beyond which mortality increases dramatically at 75 ± 2 years. Receiver operating characteristic analysis identified the "optimum age" for mortality being 68.5 years (area under the curve = 0.72, sensitivity = 66.6%, and specificity = 65.5%). CONCLUSIONS: Mortality risk for major gastrointestinal surgical resections starts increasing at 50 years of age, and at 75 years of age, it starts increasing very rapidly. The optimum age of 68.5 years predicts mortality with the best combination of sensitivity and specificity. These ages should be used to standardize outcome data and focus perioperative resources to improve outcomes.

Characterization of Lymph Node Tumor Burden in Node-Positive Prostate Cancer Patients after Robotic-Assisted Radical Prostatectomy with Extended Pelvic Lymph Node Dissection.

BACKGROUND: Prostate cancer (PCa) nodal staging does not account for lymph node (LN) tumor burden. The LN anatomical compartment involved with the tumor or the quantified extent of extranodal extension (ENE) have not yet been studied in relation to biochemical recurrence-free survival (BRFS). METHODS: Histopathological slides of 66 pN1 PCa patients who underwent extended pelvic lymph node dissection were reviewed. We recorded metrics to quantify LN tumor burden. We also characterized the LN anatomical compartments involved and quantified the extent of ENE. RESULTS: The median follow-up time was 38 months. The median number of total LNs obtained per patient was 30 (IQR 23-37). In the risk-adjusted cox regression model, the following variables were associated with BRFS: mean size of the largest LN deposit per patient (log2: adjusted hazard ratio (aHR) = 1.91, p < 0.001), the mean total span of all LN deposits per patient (2.07, p < 0.001), and the mean percent surface area of the LN involved with the tumor (1.58, p < 0.001). There was no significant BRFS association for the LN anatomical compartment or the quantified extent of ENE. CONCLUSION: LN tumor burden is associated with BRFS. The LN anatomical compartments and the quantified extent of ENE did not show significant association with BRFS.

The CUSUM Slope Equals Observed Minus Expected Mortality and Can Be Visualized by a "Slope-Meter".

We present an additional advantage of the Risk-Adjusted CUSUM (RA-CUSUM), namely, that its slope can be quantified and is in fact equivalent to Observed (O) minus Expected (E) mortality. That is, the height of the RA-CUSUM is the O minus E deaths, which measures performance since the start of the series, and the slope of the RA-CUSUM is the O minus E mortality which measures performance during a chosen interval. We present a useful graphical tool (Slope-Meter) to allow approximation of this mortality difference by the viewer.

Calibration Factors for STS Risk Model Predictions: Why, How and When They Are Used.

The Society of Thoracic Surgeons (STS) Adult Cardiac Surgery Database is the world's premier adult cardiac surgery outcomes registry. This tutorial explains the following: how STS updates the risk models that are used to calculate the predicted risks of adverse events in the registry; why STS on a quarterly basis adjusts or "calibrates" the observed-to-expected ratios to equal 1 (O/E = 1), thereby effectively making the annual number of adverse events predicted by the model match the annual number of adverse events observed in the entire registry; the differences between the calibrated and uncalibrated O/E ratios; and how and when to use each.

Comparison of 26-mm Evolut and 23-mm Sapien 3 Valves in TAVR for Small Aortic Annulus.

BACKGROUND: Patients with small aortic annuli (SAA) are prone to higher post-transcatheter aortic valve replacement (TAVR) transvalvular gradients and development of prosthesis-patient mismatch (PPM). In many patients with SAA, the choice of TAVR valve commonly involves choosing between the 26-mm Medtronic Evolut 2 (ME26) or the 23-mm Edwards Sapien 3 valve (ES23). We compared echocardiographic and clinical outcomes in patients with SAA undergoing TAVR with either valve. METHODS: We queried the Providence St. Joseph Health Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry database for patients undergoing TAVR with either the ES23 or ME26 between July 2015 and December 2018 at 11 hospitals. Post-TAVR echocardiographic and clinical results in-hospital, at 1 month, and at 1 year were examined. High gradient (HG) was defined as mean gradient (MG) ≥20 mm Hg. RESULTS: We identified 1162 patients with SAA undergoing TAVR with either the ME26 (n = 233) or ES23 valve (n = 929). Baseline characteristics between groups were similar. At 1 month, the ME26 was associated with a lower MG than the ES23 (7.7 ± 4.7 mm Hg vs 13.1 ± 4.9 mm Hg; P<.001) and moderate or severe PPM (11% and 3% vs 27% and 13%; P<.001). Occurrence of HG at 1 year was lower with the ME26 valve vs the ES23 valve (0% vs 15%; P<.001). In-hospital and follow-up clinical outcomes to 1 year were similar for both groups. CONCLUSION: TAVR in SAA with the ME26 is associated with lower incidence of HG or PPM compared with the ES23. While clinical outcomes at 1 year were similar, the long-term implications of these findings remain unknown.

Long-term results after Carpentier-Edwards pericardial aortic valve implantation, with attention to the impact of age.

BACKGROUND: The purpose of this study was to determine long-term patient survival and valve durability for Carpentier-Edwards pericardial valves (Edwards Lifesciences) implanted in the aortic position, with specific attention to the impact of patient age. METHODS: We performed a retrospective cohort study of 2168 patients who underwent implantation of a Carpentier-Edwards pericardial aortic valve between 1991 and 2008. The mean follow-up time was 4.5 years. Primary outcomes of interest were mortality and valve explantation. Survival curves and event-free curves were obtained with the Kaplan-Meier method and compared with the log-rank test. RESULTS: Survival was 92% at 1 year, 73% at 5 years, 38% at 10 years, and 18% at 15 years. Although the mortality rate of younger patients was worse than in the general population, older patients had significantly better survival than their contemporaries. Age was the independent variable most significantly associated with explantation. There was an early hazard phase for patients between 21 and 49 years of age, such that the freedom from explantation was 89% at 3 years. By 10 years, the freedom from explantation was 58% for patients 21 to 49 years of age, compared with 68% for patients 50 to 64 years, 93% for patients 65 to 74 years, and 99% for patients 75 years of age and older. CONCLUSION: We found good long-term survival and durability. Older patients had excellent freedom from explantation, whereas younger patients fared worse. As our population ages, this information becomes increasingly important. Assessing the durability of this pericardial aortic valve may aid in predicting the durability of the transcatheter aortic valves that share the same leaflets.

The economic impact of minimally invasive total hip arthroplasty.

We compared hospital length of stay (LOS) and costs between (1) minimally invasive total hip surgery (MIS) combined with an active hip pathway (AHP) and (2) long incision total hip surgery (LIS) with a passive hip pathway (PHP). A prospective consecutive cohort of 214 MIS/AHP patients was compared to a concurrent cohort of 265 LIS/PHP patients. The MIS/AHP cohort had significantly decreased LOS (1.5 days vs. 3.8 days, P < .001) and hospital costs ($12.8 thousand vs. $16.7 thousand, P < .001). The complication rates were similar for MIS/AHP and LIS/PHP. We conclude that, compared to LIS/PHP, MIS/AHP significantly shortened LOS by an average of 2.3 days, and significantly reduced hospital costs by an average of $3.9 thousand per patient.