Research Spotlight

Majhail, N. S., E. Murphy, P. Laud, J. M. Preussler, E. M. Denzen, B. Abetti, A. Adams, R. Besser, L. J. Burns, J. Cerny, R. Drexler, T. Hahn, L. Idossa, B. Jahagirdar, N. Kamani, A. Loren, D. Mattila, J. McGuirk, H. Moore, J. Reynolds, W. Saber, L. Salazar, B. Schatz, P. Stiff, J. R. Wingard, K. L. Syrjala and K. S. Baker (2019). “Randomized controlled trial of individualized treatment summary and survivorship care plans for hematopoietic cell transplantation survivors.” Haematologica 104(5): 1084-1092.

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Survivorship Care Plans (SCPs) may facilitate long-term care for cancer survivors, but their effectiveness has not been established in hematopoietic cell transplantation recipients. We evaluated the impact of individualized SCPs on patient-reported outcomes among transplant survivors. Adult (>/=18 years at transplant) survivors who were 1-5 years post transplantation, proficient in English, and without relapse or secondary cancers were eligible for this multicenter randomized trial. SCPs were developed based on risk-factors and treatment exposures using patient data routinely submitted by transplant centers to the Center for International Blood and Marrow Transplant Research and published guidelines for long-term follow up of transplant survivors. Phone surveys assessing patient-reported outcomes were conducted at baseline and at 6 months. The primary end point was confidence in survivorship information, and secondary end points included cancer and treatment distress, knowledge of transplant exposures, health care utilization, and health-related quality of life. Of 495 patients enrolled, 458 completed a baseline survey and were randomized (care plan=231, standard care=227); 200 (87%) and 199 (88%) completed the 6-month assessments, respectively. Patients’ characteristics were similar in the two arms. Participants on the care plan arm reported significantly lower distress scores at 6 months and an increase in the Mental Component Summary quality of life score assessed by the Short Form 12 (SF-12) instrument. No effect was observed on the end point of confidence in survivorship information or other secondary outcomes. Provision of individualized SCPs generated using registry data was associated with reduced distress and improved mental domain of quality of life among 1-5 year hematopoietic cell transplantation survivors. Trial registered at clinicaltrials.gov 02200133.

Levitsky, J., S. K. Asrani, M. Abecassis, R. Ruiz, L. W. Jennings and G. Klintmalm (2019). “External Validation of a Pre-Transplant Biomarker Model (REVERSE) Predictive of Renal Recovery after Liver Transplantation.” Hepatology Apr 19. [Epub ahead of print].

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In patients with end stage liver disease, the ability to predict recovery of renal function following liver transplantation alone (LTA) remains elusive. However, several important clinical decisions depend on whether renal dysfunction is recoverable after LTA. We used a cohort of patients undergoing LT to independently validate a pre-LT model predictive of post-LTA renal recovery (REVERSE: high osteopontin (OPN) and tissue inhibitor of metalloproteinases-1 (TIMP-1) levels, age <57, no diabetes). Serum samples pre-LT and 4-12 weeks post-LTA (n=117) were analyzed for kidney injury proteins from 3 groups of recipients: (1) estimated GFR (eGFR)<30ml/min/1.73m(2) prior to LTA and <30 ml/min/1.73m(2) after LTA (irreversible acute kidney injury = iAKI), (2) eGFR<30ml/min/1.73m(2) prior to LTA and >50 ml/min/1.73m(2) after LTA (reversible AKI = rAKI) (3) eGFR>50 ml/min/1.73m(2) prior to LTA and >50 ml/min/1.73m(2) after LTA (no AKI = nAKI). In patients with elevated pre-LTA serum levels of OPN and TIMP-1, recovery of renal function correlated with decreases in the level of both proteins. At four weeks post-LT (n=77 subset), the largest decline in OPN and TIMP-1 was seen in the rAKI group. Validation of the REVERSE model in this independent dataset had high area under the curve (AUC) (0.78) in predicting full post-LT renal recovery (sensitivity 0.86, specificity 0.6, PPV 0.81, NPV 0.69). Our eGFR findings were confirmed using measured GFR (mGFR). CONCLUSION: The REVERSE model, derived from an initial training set combining novel plasma biomarkers and clinical characteristics, demonstrated excellent external validation performance characteristics in an independent patient cohort using serum samples. Among patients with kidney injury pre-LTA, the predictive ability of this simple tool may prove beneficial in clinical decision-making both prior to and following transplantation.

Leeds, S. G., M. Mencio, E. Ontiveros and M. A. Ward (2019). “Endoluminal Vacuum Therapy: How I Do It.” J Gastrointest Surg 23(5): 1037-1043.

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Perforations and leaks of the gastrointestinal tract are difficult to manage and are associated with high morbidity and mortality. Recently, endoscopic approaches have been applied with varying degrees of success. Most recently, the use of endoluminal vacuum therapy has been used with high success rates in decreasing both morbidity and mortality. Under an IRB-approved prospective registry that we started in July 2013, we have been using endoluminal vacuum therapy to treat a variety of leaks throughout the GI tract. The procedure uses an endosponge connected to a nasogastric tube that is endoscopically guided into a fistula cavity in order to facilitate healing, obtain source control, and aid in reperfusion of the adjacent tissue with debridement. Endoluminal vacuum therapy has been used on all patients in the registry. Overall success rate for healing the leak or fistula is 95% in the esophagus, 83% in the stomach, 100% in the small bowel, and 60% of colorectal cases. The purpose of this report is to review the history of endoluminal wound vacuum therapy, identify appropriate patient selection criteria, and highlight “pearls” of the procedure. This article is written in the context of our own clinical experience, with a primary focus on a “How I Do It” technical description.

Kwong, A. J., A. Wall, M. Melcher, U. Wang, A. Ahmed, A. Subramanian and P. Y. Kwo (2019). “Liver transplantation for hepatitis C virus (HCV) non-viremic recipients with HCV viremic donors.” Am J Transplant 19(5): 1380-1387.

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In the context of organ shortage, the opioid epidemic, and effective direct-acting antiviral (DAA) therapy for hepatitis C virus (HCV), more HCV-infected donor organs may be used for liver transplantation. Current data regarding outcomes after donor-derived HCV in previously non-viremic liver transplant recipients are limited. Clinical data for adult liver transplant recipients with donor-derived HCV infection from March 2017 to January 2018 at our institution were extracted from the medical record. Ten patients received livers from donors known to be infected with HCV based on positive nucleic acid testing. Seven had a prior diagnosis of HCV and were treated before liver transplantation. All recipients were non-viremic at the time of transplantation. All 10 recipients derived hepatitis C infection from their donor and achieved sustained virologic response at 12 weeks posttreatment with DAA-based regimens, with a median time from transplant to treatment initiation of 43 days (IQR 20-59). There have been no instances of graft loss or death, with median follow-up of 380 days (IQR 263-434) posttransplant. Transplantation of HCV-viremic livers into non-viremic recipients results in acceptable short-term outcomes. Such strategies may be used to expand the donor pool and increase access to liver transplantation.

Kline, R. M., M. Brown, N. Buescher, J. Cox, E. Horenkamp, R. Hoverman, M. Neubauer, R. Oyer, A. M. F. Rainey and L. Strawbridge (2019). “The Centers for Medicare & Medicaid Services Oncology Care Model Halfway Through – Perspectives from Diverse Participants.” J Natl Cancer Inst May 3. [Epub ahead of print].

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The Oncology Care Model (OCM) is a 5-year model developed and tested by the Centers for Medicare & Medicaid Services that uses an episode-based payment model triggered by the receipt of chemotherapy to test if changing payment mechanisms, in conjunction with a requirement for enhanced patient services, can generate clinical transformation that will orient practices more towards more patient-centered, high-value care in order to reduce expenditures and preserve or enhance quality of care for beneficiaries. The model is geographically diverse with practices in 34 states, and encompasses practices ranging in size from 1 to over 400 practitioners, with a multitude of business structures. Given these varied clinical and business environments, we believe that OCM participating practices will have different opportunities and challenges as they work towards practice transformation, but they will likely share similarities with other practices in similar clinical and business settings. This paper shares the experiences of four diverse groups participating in OCM, three practices and one network of practices, halfway through the model’s projected 5-year lifecycle in the expectation that these experiences will be of value to other practices embarking toward patient-centered, high-value practice transformation.