Research Spotlight

Wood, D.S., Watson, S.L., Eckel, T.M., Peters, P.C., Jr., Kitziger, K.J. and Gladnick, B.P. (2021). “Decreased costs with maintained patient satisfaction after total joint arthroplasty in a physician-owned hospital.” J Orthop 24: 212-215.

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OBJECTIVE: Comparing total joint arthroplasty (TJA) costs and patient-reported outcomes between a physician-owned hospital (POH) and a non-POH. METHODS: Costs for each 90-day TJA episode at both facilities were determined, and patients were asked to complete a patient satisfaction questionnaire. RESULTS: Average TJA episode cost was $19,039 at the POH, compared to $21,302 at the non-POH, a difference of $2,263 (p = 0.03), largely driven by decreased skilled nursing facility utilization in the POH group. There were no differences between groups for patient satisfaction. CONCLUSION: TJA can be performed at reduced cost with comparable patient satisfaction at POHs, compared to non-POH facilities.

Witkowski, P., Philipson, L.H., Kaufman, D.B., Ratner, L.E., Abouljoud, M.S., Bellin, M.D., Buse, J.B., Kandeel, F., Stock, P.G., Mulligan, D.C., Markmann, J.F., Kozlowski, T., Andreoni, K.A., Alejandro, R., Baidal, D.A., Hardy, M.A., Wickrema, A., Mirmira, R.G., Fung, J., Becker, Y.T., Josephson, M.A., Bachul, P.J., Pyda, J.S., Charlton, M., Millis, J.M., Gaglia, J.L., Stratta, R.J., Fridell, J.A., Niederhaus, S.V., Forbes, R.C., Jayant, K., Robertson, R.P., Odorico, J.S., Levy, M.F., Harland, R.C., Abrams, P.L., Olaitan, O.K., Kandaswamy, R., Wellen, J.R., Japour, A.J., Desai, C.S., Naziruddin, B., Balamurugan, A.N., Barth, R.N. and Ricordi, C. (2021). “The demise of islet allotransplantation in the United States: A call for an urgent regulatory update.” Am J Transplant 21(4): 1365-1375.

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Islet allotransplantation in the United States (US) is facing an imminent demise. Despite nearly three decades of progress in the field, an archaic regulatory framework has stymied US clinical practice. Current regulations do not reflect the state-of-the-art in clinical or technical practices. In the US, islets are considered biologic drugs and “more than minimally manipulated” human cell and tissue products (HCT/Ps). In contrast, across the world, human islets are appropriately defined as “minimally manipulated tissue” and not regulated as a drug, which has led to islet allotransplantation (allo-ITx) becoming a standard-of-care procedure for selected patients with type 1 diabetes mellitus. This regulatory distinction impedes patient access to islets for transplantation in the US. As a result only 11 patients underwent allo-ITx in the US between 2016 and 2019, and all as investigational procedures in the settings of a clinical trials. Herein, we describe the current regulations pertaining to islet transplantation in the United States. We explore the progress which has been made in the field and demonstrate why the regulatory framework must be updated to both better reflect our current clinical practice and to deal with upcoming challenges. We propose specific updates to current regulations which are required for the renaissance of ethical, safe, effective, and affordable allo-ITx in the United States.

Wang, R., Tomaniak, M., Takahashi, K., Gao, C., Kawashima, H., Hara, H., Ono, M., van Klaveren, D., van Geuns, R.J., Morice, M.C., Davierwala, P.M., Mack, M.J., Witkowski, A., Curzen, N., Berti, S., Burzotta, F., James, S., Kappetein, A.P., Head, S.J., Thuijs, D., Mohr, F.W., Holmes, D.R., Tao, L., Onuma, Y. and Serruys, P.W. (2021). “Impact of chronic obstructive pulmonary disease on 10-year mortality after percutaneous coronary intervention and bypass surgery for complex coronary artery disease: insights from the SYNTAX Extended Survival study.” Clin Res Cardiol Mar 12. {Epub ahead of print].

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AIMS: To evaluate the impact of chronic obstructive pulmonary disease (COPD) on 10-year all-cause death and the treatment effect of CABG versus PCI on 10-year all-cause death in patients with three-vessel disease (3VD) and/or left main coronary artery disease (LMCAD) and COPD. METHODS: Patients were stratified according to COPD status and compared with regard to clinical outcomes. Ten-year all-cause death was examined according to the presence of COPD and the revascularization strategy. RESULTS: COPD status was available for all randomized 1800 patients, of whom, 154 had COPD (8.6%) at the time of randomization. Regardless of the revascularization strategy, patients with COPD had a higher risk of 10-year all-cause death, compared with those without COPD (43.1% vs. 24.9%; hazard ratio [HR]: 2.03; 95% confidence interval [CI]: 1.56-2.64; p < 0.001). Among patients with COPD, CABG appeared to have a slightly lower risk of 10-year all-cause death compared with PCI (42.3% vs. 43.9%; HR: 0.96; 95% CI: 0.59-1.56, p = 0.858), whereas among those without COPD, CABG had a significantly lower risk of 10-year all-cause death (22.7% vs. 27.1%; HR: 0.81; 95% CI: 0.67-0.99, p = 0.041). There was no significant differential treatment effect of CABG versus PCI on 10-year all-cause death between patients with and without COPD (p (interaction) = 0.544). CONCLUSIONS: COPD was associated with a higher risk of 10-year all-cause death after revascularization for complex coronary artery disease. The presence of COPD did not significantly modify the beneficial effect of CABG versus PCI on 10-year all-cause death. TRIAL REGISTRATION: SYNTAX: ClinicalTrials.gov reference: NCT00114972. SYNTAX Extended Survival: ClinicalTrials.gov reference: NCT03417050.

Wada, Y., Shimada, M., Yamamura, K., Toshima, T., Banwait, J.K., Morine, Y., Ikemoto, T., Saito, Y., Baba, H., Mori, M. and Goel, A. (2021). “A transcriptomic signature for risk-stratification and recurrence prediction in intrahepatic cholangiocarcinoma.” Hepatology Mar 16. [Epub ahead of print].

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BACKGROUND & AIMS: Tumor recurrence is frequent even in intrahepatic cholangiocarcinoma (ICC); and improved strategies are needed to identify patients at highest risk for such recurrence. We performed genome-wide expression profile analyses to discover and validate a gene signature associated with recurrence in patients with ICC. APPROACH & RESULTS: For biomarker discovery, we analyzed genome-wide transcriptomic profiling in ICC tumors from two public datasets (TCGA, n=27 and GSE107943, n=28). We identified an 8-gene panel (BIRC5, CDC20, CDH2, CENPW, JPH1, MAD2L1, NEIL3, and POC1A), which robustly identified patients with recurrence in the discovery (area under the curve [AUC]=0.92) and in-silico validation cohorts (AUC=0.91). We next analyzed 241 specimens from patients with ICC (training cohort: n=64, validation cohort: n=177), followed by Cox proportional hazard regression analysis, to develop an integrated transcriptomic panel and establish a risk-stratification model for recurrence in ICC. We subsequently trained this transcriptomic panel in a clinical cohort (AUC=0.89, 95% confidence intervals [CI]=0.79-0.95), followed by evaluating its performance in an independent validation cohort (AUC=0.86, 95% CI=0.80-0.90). By combining our transcriptomic panel with various clinicopathologic features we established a risk-stratification model which was significantly superior for the identification of recurrence (AUC=0.89, Univariate: hazard ratio [HR]=6.08, 95% CI=3.55-10.41, P<0.01; Multivariate: HR=3.49, 95% CI=1.81-6.71, P<0.01). The risk-stratification model identified potential recurrence in 85% of high-risk patients and non-recurrence in 76% of low-risk patients, which is dramatically superior to currently used pathological features. CONCLUSIONS: We report a novel transcriptomic signature for risk-stratification and recurrence prediction that is superior to currently used clinicopathological features in patients with ICC.

Verhey, J.T., Verhey, E., Holland, D., Baker, J.C. and Long, J.R. (2021). “Ulnar shaft stress fractures in fast-pitch softball pitchers: a case series and proposed mechanism of injury.” Skeletal Radiol 50(4): 835-840.

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BACKGROUND: Stress fractures of the upper extremities in athletes are important injuries for radiologists to appreciate despite being far less common than stress fractures of the lower extremities. Among upper extremity stress fractures, those involving the olecranon have been well described in overhead pitching athletes. Isolated stress fractures of the ulnar shaft however are less commonly reported in the literature and considered to be rare. We have observed a correlation between young patients with ulnar shaft stress fractures and the activity of fast-pitch softball pitching. CASE REPORTS: In this series, we present the imaging findings in four cases of ulnar shaft stress fractures in softball pitchers who presented with insidious onset forearm pain. Furthermore, a review of the literature focusing on softball pitching mechanics is provided to offer a potential underlying mechanism for the occurrence and location of these injuries. CONCLUSION: An awareness of the imaging appearance of ulnar shaft stress fractures along with an understanding of its proposed mechanism will facilitate accurate and timely imaging diagnosis of this injury by the radiologist.