Research Spotlight

Leeds, S.G., Ngov, A., G, O.O. and Ward, M.A. (2020). “Safety of magnetic sphincter augmentation in patients with prior bariatric and anti-reflux surgery.” Surg Endosc Sep 28. [Epub ahead of print.].

Full text of this article.

BACKGROUND: Magnetic sphincter augmentation (MSA) has been recognized as an effective treatment option for patients with gastroesophageal reflux disease. The feasibility of MSA in patients with prior gastric surgery has not been well established. This study aims to evaluate the safety and efficacy of MSA in patients with prior gastric surgery including bariatric and other anti-reflux operations. METHODS: A prospectively gathered registry approved by the institutional review board for patients undergoing anti-reflux surgery was retrospectively reviewed. All patients who underwent MSA were included. The patients were divided into two groups based on the presence of prior gastric surgeries compared to those without. Endpoints collected include differences between the two groups in their preoperative evaluation, perioperative course, and postoperative effectiveness. RESULTS: A total of 103 patients underwent MSA where 82 patients (80%) had no prior gastric surgery and 21 patients (20%) had prior gastric surgery. The prior gastric surgery group included 10 patients with prior anti-reflux surgery, 11 patients with prior bariatric surgery. Perioperative factors were higher in the prior gastric surgery group including operating room time (135 min vs. 93 min, p =  < 0.001), number of beads used (16 vs. 14, p =  < 0.001), and percent of patients staying overnight (47% vs. 5%, p =  < 0.001). There was no difference in several factors of their preoperative evaluation including preoperative GERD-HRQL and RSI scores, hiatal hernia presence, or DeMeester score. Post-operative GERD-HRQL and RSI scores were not different as well as patient satisfaction, patients resuming PPI use, and device explant rate. CONCLUSIONS: This study demonstrates equivalent outcomes with integration of MSA in patients with prior gastric surgery in comparison to patients without prior gastric surgery. However, these surgeries are longer, require larger devices, and patients are more likely to stay overnight.

Lat, T.I., Patel, C.D., Ehrig, J.C., Moslander, C. and Sanchez, J.F. (2020). “Therapeutic Options in the Treatment of SARS-CoV-2 in the Pregnant Patient.” Am J Obstet Gynecol MFM Sep 12;100224. [Epub ahead of print.].

Full text of this article.

The SARS-CoV-2 pandemic has resulted in the development of various therapeutics to treat and prevent major complications related to the virus; pregnant patients are vulnerable to acquiring SARS-CoV-2 due to frequent contact with the healthcare setting. Despite publication of a plethora of case series and randomized control trials of SARS- CoV-2 therapeutics, few have addressed treatment in the pregnant population. To date, there have been no published review of therapeutics in the pregnant patient infected with SARS-CoV-2. We provide the first review of available treatments for SARS-CoV-2, various trials with inclusion and exclusion of the pregnant patients, and potential side effects of each treatment in the pregnant patient.

Mahale, P., McKenna, G.J., Saracino, G., Jennings, L., Mbulaiteye, S.M., Klintmalm, G.B. and Engels, E.A. (2020). “Hypomagnesemia and risk of post-transplant lymphoproliferative disorder in liver transplant recipients.” Transpl Int Sep 7. [Epub ahead of print.].

Full text of this article.

Liver recipients have substantial risk of post-transplant lymphoproliferative disorder (PTLD) [1]. Most PTLDs result from uncontrolled replication of Epstein-Barr virus (EBV) due to immunosuppressive therapy [1]. A role of magnesium in modulating immune response and in lymphomagenesis is increasingly being recognized [2]. Decreased intracellular magnesium causes impaired T-cell and B-cell function, decreased expression of natural killer-activating receptor (NKG2D) in natural killer and T-cells leading to a blunted anti-EBV response, and increased risk of EBV-positive lymphomas [2, 3]. Hypomagnesemia was associated with EBV viral load and Burkitt lymphoma in Ugandan women, and associations of EBV with other lymphomas are also documented [4].

Agopian, V.G., Markovic, D., Klintmalm, G.B., Saracino, G., Chapman, W.C., Vachharajani, N., Florman, S.S., Tabrizian, P., Haydel, B., Nasralla, D., Friend, P.J., Boteon, Y.L., Ploeg, R., Harlander-Locke, M.P., Xia, V., DiNorcia, J., Kaldas, F.M., Yersiz, H., Farmer, D.G. and Busuttil, R.W. (2020). “Multicenter validation of the liver graft assessment following transplantation (L-GrAFT) score for assessment of early allograft dysfunction.” J Hepatol Sep 22;S0168-8278(20)33627-8. [Epub ahead of print.].

Full text of this article.

BACKGROUND AIMS: Early allograft dysfunction (EAD) following liver transplantation (LT) negatively impacts graft and patient outcomes. The Liver Graft Assessment Following Transplantation (L-GrAFT(7)) risk-score estimates 3-month graft-failure-free survival (area under the receiver operator characteristic [AUROC] curve=0.83), and was superior to the binary EAD (AUROC=0.68) definition and Model for Early Allograft Function (MEAF, AUROC=0.70) in the single-center derivation cohort (DC, n=2008). We sought to externally validate L-GrAFT(7), and compare its prognostic performance to EAD and MEAF. METHODS: Accuracies of L-GrAFT(7), EAD, and MEAF were compared in a 3-center US validation cohort (VC, n=3201), and Consortium for Organ Preservation in Europe (COPE) normothermic machine perfusion trial cohort (n=222), with comparison of characteristics to assess generalizability. RESULTS: Compared to the DC, VC and COPE patients had lower recipient median MELD scores (18 and 14 vs 31); were less likely to require pretransplant hospitalization (23.3% and 0% vs 46.1%), renal replacement therapy (8.8% and 1.8% vs 31.7%), mechanical ventilation (3.7% and 0% vs 19.8%); and had superior 1-year overall (90% and 95% vs 84%) and graft-failure-free (88% and 93% vs 81%) survival, with a lower incidence of 3-month graft failure (7.4% and 4.0% vs. 11.1%; P<0.001 for all comparisons). Despite significant differences in cohort characteristics, L-GrAFT(7) maintained an excellent validation AUROC of 0.78, significantly superior to the EAD (AUROC=0.68, P=0.001) and MEAF scores (AUROC=0.72, P<0.001). In post-hoc analysis of COPE NMP trial, highest tertile of L-GrAFT(7) was significantly associated with time to liver allograft (HR 2.17, P=0.016) and Clavien ≥IIIB (HR 2.60, P=0.034) and ≥IVa (HR 4.99, P=0.011) complications, and post-LT length of hospitalization (P=0.002) and renal replacement therapy (OR 3.62, P=0.016). CONCLUSIONS: We have validated the L-GrAFT(7) risk score as a generalizable, highly accurate, individualized risk assessment of 3-month liver allograft failure that is superior to the existing EAD and MEAF scores. L-GrAFT(7) may standardize grading of early hepatic allograft function, and serve as a clinical end-point in translational studies aiming to mitigate ischemia-reperfusion injury. LAY SUMMARY: Early allograft dysfunction negatively affects outcomes following liver transplantation (LT). In independent multicenter US and European cohorts totaling 3423 patients undergoing LT, the Liver Graft Assessment Following Transplantation (L-GrAFT) risk score is validated as a superior measure of early allograft function that accurately discriminates 3-month graft failure free survival and post-LT complications.

Osuji, T.A., Frantsve-Hawley, J., Jolles, M.P., Kitzman, H., Parry, C. and Gould, M.K. (2020). “Methods to identify and prioritize research projects and perform embedded research in learning healthcare systems.” Healthc (Amst) Sep 29;8(4):100476. [Epub ahead of print.].

Full text of this article.

BACKGROUND: The Embedded Healthcare Research Conference aimed to promote and enhance research-operations partnerships in diverse health care settings. Within this conference, the Priorities and Methods Workgroup set out to define a vision of embedded research that leverages diverse methods to address clearly articulated research questions of importance to health systems. METHODS: The Workgroup session involved a combination of small and large group discussions around three broadly focused topics: the integration of embedded research within the existing quality improvement (QI) ecosystem; the identification, prioritization and formulation of embedded research questions; the creation of an embedded research “tool kit.” RESULTS: Workgroup participants envisioned a future for embedded research that is characterized by authentic engagement between researchers and health system leaders; seamless integration between research, QI and clinical operations; clear and explicit articulation of research questions; an appropriate balance between rigor and relevance in applied methodology; alignment between study design, available resources and the importance of the knowledge to be gained; efficient processes; and bi-directional communication. Important barriers to achieving this vision include limited access to executive leaders, silos that discourage integration of research and QI, generally low tolerance for disruption in high-risk clinical settings, limited access to data, and limited availability of researchers with requisite skills and training. CONCLUSIONS: Embedded research holds potential to enhance the relevance, value and use of research, while also creating generalizable knowledge. Key recommendations include building authentic relationships, discouraging silos, encouraging innovation and experimentation, and expanding opportunities for funding research in delivery systems.