Publications by authors named "Shimul A Shah"

200 Publications

Optimal Timing of Administration of Direct-acting Antivirals for Patients With Hepatitis C-associated Hepatocellular Carcinoma Undergoing Liver Transplantation.

Ann Surg 2021 10;274(4):613-620

University of Michigan, Ann Arbor, Michigan.

Objective: To investigate the optimal timing of direct acting antiviral (DAA) administration in patients with hepatitis C-associated hepatocellular carcinoma (HCC) undergoing liver transplantation (LT).

Summary Of Background Data: In patients with hepatitis C (HCV) associated HCC undergoing LT, the optimal timing of direct-acting antivirals (DAA) administration to achieve sustained virologic response (SVR) and improved oncologic outcomes remains a topic of much debate.

Methods: The United States HCC LT Consortium (2015-2019) was reviewed for patients with primary HCV-associated HCC who underwent LT and received DAA therapy at 20 institutions. Primary outcomes were SVR and HCC recurrence-free survival (RFS).

Results: Of 857 patients, 725 were within Milan criteria. SVR was associated with improved 5-year RFS (92% vs 77%, P < 0.01). Patients who received DAAs pre-LT, 0-3 months post-LT, and ≥3 months post-LT had SVR rates of 91%, 92%, and 82%, and 5-year RFS of 93%, 94%, and 87%, respectively. Among 427 HCV treatment-naïve patients (no previous interferon therapy), patients who achieved SVR with DAAs had improved 5-year RFS (93% vs 76%, P < 0.01). Patients who received DAAs pre-LT, 0-3 months post-LT, and ≥3 months post-LT had SVR rates of 91%, 93%, and 78% (P < 0.01) and 5-year RFS of 93%, 100%, and 83% (P = 0.01).

Conclusions: The optimal timing of DAA therapy appears to be 0 to 3 months after LT for HCV-associated HCC, given increased rates of SVR and improved RFS. Delayed administration after transplant should be avoided. A prospective randomized controlled trial is warranted to validate these results.
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http://dx.doi.org/10.1097/SLA.0000000000005070DOI Listing
October 2021

Expanding the Donor Pool: First Use of Hepatitis B Virus Nat Positive Solid Organ Allografts Into Seronegative Recipients.

Ann Surg 2021 10;274(4):556-564

Cincinnati Research in Outcomes and Safety in Surgery (CROSS) Research Group, Department of Surgery, University of Cincinnati College of Medicine, Cincinnati, OH.

Objectives: The aim of this study was to assess the 1-year safety and effectiveness of HBV Nucleic Acid Test positive (HBV NAT+) allografts in seronegative kidney transplant (KT) and liver transplant (LT) recipients.

Summary Background Data: Despite an ongoing organ shortage, the utilization of HBV NAT+ allografts into seronegative recipients has not been investigated.

Methods: From January 2017 to October 2020, a prospective cohort study was conducted among consecutive KT and LT recipients at a single institution. Primary endpoints were post-transplant HBV viremia, graft and patient survival.

Results: With median follow-up of 1-year, there were no HBV-related complications in the 89 HBV NAT+ recipients. Only 9 of 56 KTs (16.1%) and 9 of 33 LTs (27.3%) experienced post-transplant HBV viremia at a median of 185 (KT) and 269 (LT) days postoperatively. Overall, viremic episodes resolved to undetected HBV DNA after a median of 80 days of entecavir therapy in 16 of 18 recipients. Presently, 100% of KT recipients and 93.9% of LT recipients are HBV NAT- with median follow-up of 13 months, whereas 0 KT and 8 LT (24.2%) recipients are HBV surface antigen positive indicating chronic infection. KT and LT patient and allograft survival were not different between HBV NAT+ and HBV NAT- recipients (P > 0.05), whereas HBV NAT+ KT recipients had decreased waitlist time and pretransplant duration on dialysis (P < 0.01).

Conclusions: This is the largest series describing the transplantation of HBV NAT+ kidney and liver allografts into HBV seronegative recipients without chronic HBV viremia or decreased 1-year patient and graft survival. Increasing the utilization of HBV NAT+ organs in nonviremic recipients can play a role in decreasing the national organ shortage.
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http://dx.doi.org/10.1097/SLA.0000000000005071DOI Listing
October 2021

The Opportunity for Impactful Policy Change in Liver Transplantation-Expanding Our Definition of Quality.

JAMA Netw Open 2021 Aug 2;4(8):e2119336. Epub 2021 Aug 2.

Cincinnati Research in Outcomes and Safety in Surgery (CROSS) Research Group, Department of Surgery, University of Cincinnati College of Medicine, Cincinnati, Ohio.

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http://dx.doi.org/10.1001/jamanetworkopen.2021.19336DOI Listing
August 2021

Review of Use of Y90 as a Bridge to Liver Resection and Transplantation in Hepatocellular Carcinoma.

J Gastrointest Surg 2021 Oct 3;25(10):2690-2699. Epub 2021 Aug 3.

Department of Surgery, University of Cincinnati College of Medicine Medical Sciences Building, Room 1555, 231, Sabin Way Cincinnati, Albert, OH, 45267, USA.

Background: The incidence of hepatocellular carcinoma (HCC) has been rising, and 80% of HCCs are unresectable at the time of presentation. In recent years, Yttrium-90 (Y90) radioembolization has arisen as a potential tool to treat the primary HCC tumor while also inducing contralateral liver hypertrophy to increase future liver remnant volumes. The goal of this multidisciplinary review is to summarize the contemporary evidence on the safety, efficacy, and utility of Y90 as a bridge to liver resection and transplant in patients with HCC.

Methods: A narrative review was conducted of the recent literature regarding the utilization of Y90 as a therapy prior to liver resection or transplant in patients with HCC. A specific emphasis was placed on articles published in the last 10 years.

Results: Y90 radioembolization has demonstrated a high safety profile and increasing utility in bridging and downstaging patients with HCC who subsequently undergo liver resection or transplant. The continuous advancements in treatment strategies and radiation dosimetry have paved the way for the incorporation of Y90 in all stages of HCC with different intents, including downstaging and bridging.

Conclusions: Y90 radioembolization can be safely used in the HCC population to bridge patients to resection or transplantation, induce future liver remnant growth, and select for less aggressive tumor biology prior to surgery.
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http://dx.doi.org/10.1007/s11605-021-05095-xDOI Listing
October 2021

Best practice recommendations for the use of hepatitis C viremic donor organs for hepatitis C virus naïve recipients.

Clin Transplant 2021 08 16;35(8):e14381. Epub 2021 Jun 16.

Department of Surgery, University of Iowa Carver College of Medicine, Iowa City, IA, USA.

The combination of the transplant organ deficit, the increase in HCV nucleic acid positive donors (HCV NAT+), and the development of direct-acting antiviral agents (DAAs) has resulted in a rapid increase in HCV NAT+ organ transplants into HCV naïve recipients. Early clinical experience with HCV NAT+ donor organs has shown promising outcomes; however, best practices are lacking to guide transplant programs during all phases of patient care. Transplant programs developing protocols for the utilization of HCV NAT+ organs will need a multidisciplinary team to address all aspects of pre-transplant and post-transplant patient care. Reports of fibrosing cholestatic hepatitis in HCV NAT+ organ transplant recipients receiving delayed DAA initiation highlight the need for the transplant community to develop safe and effective protocols. A failure to do so will inevitably lead to the erosion of public trust from cases of missed or inadequately treated donor-derived HCV infections. Herein, we provide best practice guidelines for the utilization of HCV NAT+ organs into HCV-negative recipients based on literature review and expert opinion from the faculty of the ASTS Standards and Quality Committee.
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http://dx.doi.org/10.1111/ctr.14381DOI Listing
August 2021

Pulmonary Vascular Resistance Predicts Mortality and Graft Failure in Transplantation Patients With Portopulmonary Hypertension.

Liver Transpl 2021 May 8. Epub 2021 May 8.

Division of Pulmonary, Critical Care, and Sleep Medicine, University of Cincinnati, Cincinnati, OH.

Portopulmonary hypertension (POPH) is a pulmonary vascular disease associated with significant morbidity and mortality in those with liver disease, conferring a higher mortality in patients awaiting liver transplantation (LT). Although not a transplant indication, patients with POPH can experience significant clinical improvement following LT, and those maintaining a mean pulmonary artery pressure (MPAP) <35mm Hg and a pulmonary vascular resistance (PVR) <5 Woods units (WU) are granted additional listing points to expedite LT. The effect of POPH on posttransplant outcomes such as mortality and graft failure, however, is not well defined. We performed a retrospective cohort study of the US Organ Procurement and Transplantation Network database of all adult patients who underwent LT between January 1, 2006, and December 1, 2020. Using adjusted accelerated failure time models, we examined the relationship between a diagnosis of POPH and outcomes following LT and the relationship between pre-LT hemodynamics and post-LT survival (alive with a functioning graft) in patients with POPH. Compared with those undergoing transplants without exception points, patients with POPH had comparable post-LT survival rates but were significantly more likely to have graft failure. Both pre-LT MPAP and PVR predicted post-LT survival in POPH, with a pre-LT PVR of ≥1.6 WU, more than doubling the hazard for mortality (death or a nonfunctioning graft; coefficient, 2.01; standard error, 0.85; hazard ratio, 2.21; P = 0.02). POPH may confer a significantly higher risk of post-LT graft failure compared with patients with cirrhosis without POPH, and a pre-LT PVR of ≥1.6 WU may predict post-LT survival. Further investigation into the relationship between pre-LT hemodynamics, right ventricular function, and post-LT outcomes of mortality and graft failure in POPH is needed.
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http://dx.doi.org/10.1002/lt.26091DOI Listing
May 2021

BIR repeat-containing ubiquitin conjugating enzyme (BRUCE) regulation of β-catenin signaling in the progression of drug-induced hepatic fibrosis and carcinogenesis.

World J Hepatol 2021 Mar;13(3):343-361

Department of Cancer Biology, University of Cincinnati, Cincinnati, OH 45267, United States.

Background: BIR repeat-containing ubiquitin conjugating enzyme (BRUCE) is a liver tumor suppressor, which is downregulated in a large number of patients with liver diseases. BRUCE facilitates DNA damage repair to protect the mouse liver against the hepatocarcinogen diethylnitrosamine (DEN)-dependent acute liver injury and carcinogenesis. While there exists an established pathologic connection between fibrosis and hepatocellular carcinoma (HCC), DEN exposure alone does not induce robust hepatic fibrosis. Further studies are warranted to identify new suppressive mechanisms contributing to DEN-induced fibrosis and HCC.

Aim: To investigate the suppressive mechanisms of BRUCE in hepatic fibrosis and HCC development.

Methods: Male C57/BL6/J control mice [loxp/Loxp; albumin-cre (Alb-cre)] and BRUCE Alb-Cre KO mice (loxp/Loxp; Alb-Cre) were injected with a single dose of DEN at postnatal day 15 and sacrificed at different time points to examine liver disease progression.

Results: By using a liver-specific BRUCE knockout (LKO) mouse model, we found that BRUCE deficiency, in conjunction with DEN exposure, induced hepatic fibrosis in both premalignant as well as malignant stages, thus recapitulating the chronic fibrosis background often observed in HCC patients. Activated in fibrosis and HCC, β-catenin activity depends on its stabilization and subsequent translocation to the nucleus. Interestingly, we observed that livers from BRUCE KO mice demonstrated an increased nuclear accumulation and elevated activity of β-catenin in the three stages of carcinogenesis: Pre-malignancy, tumor initiation, and HCC. This suggests that BRUCE negatively regulates β-catenin activity during liver disease progression. β-catenin can be activated by phosphorylation by protein kinases, such as protein kinase A (PKA), which phosphorylates it at Ser-675 (pSer-675-β-catenin). Mechanistically, BRUCE and PKA were colocalized in the cytoplasm of hepatocytes where PKA activity is maintained at the basal level. However, in BRUCE deficient mouse livers or a human liver cancer cell line, both PKA activity and pSer-675-β-catenin levels were observed to be elevated.

Conclusion: Our data support a "BRUCE-PKA-β-catenin" signaling axis in the mouse liver. The BRUCE interaction with PKA in hepatocytes suppresses PKA-dependent phosphorylation and activation of β-catenin. This study implicates BRUCE as a novel negative regulator of both PKA and β-catenin in chronic liver disease progression. Furthermore, BRUCE-liver specific KO mice serve as a promising model for understanding hepatic fibrosis and HCC in patients with aberrant activation of PKA and β-catenin.
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http://dx.doi.org/10.4254/wjh.v13.i3.343DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8006081PMC
March 2021

Liver Transplant for Extensive Colorectal Liver Cancer Metastases: Another Tool in the Arsenal?

JAMA Surg 2021 Jun;156(6):558

Solid Organ Transplantation, Department of Surgery, University of Cincinnati College of Medicine, Cincinnati, Ohio.

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http://dx.doi.org/10.1001/jamasurg.2021.0269DOI Listing
June 2021

The current status of virus-positive liver transplantation.

Curr Opin Organ Transplant 2021 04;26(2):160-167

The Department of Surgery, University of Cincinnati.

Purpose Of Review: The last 2 years have seen significant developments in virus-positive liver transplantation. This review provides an updated account of the transplantation of hepatitis C virus (HCV), hepatitis B virus (HBV) and HIV-positive livers, with a specific focus on studies published in the last 18 months.

Recent Findings: The advent of highly efficacious direct acting antiviral agents, nucleos(t)ide analogues and a continued organ shortage have led to the well tolerated utilization of HCV, HBV and HIV-positive organs. There has been a significant increase in the transplantation of HCV seropositive and NAT+ organs into HCV-negative recipients, without compromising patient or graft survival. Early reports of HBV core antibody (HBVcAb), HBV surface antigen (HBVsAg) positive and NAT+ donors are growing in the USA with promising results. Similarly, small studies have described the use of HIV-positive to HIV-positive liver transplantation without concerns for superinfection.

Summary: HCV, HBV and HIV-positive liver transplantations can be accomplished safely and are associated with equivalent outcomes when paired with appropriate recipients. The practice of virus positive liver transplantation should be encouraged to combat the ongoing organ shortage.
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http://dx.doi.org/10.1097/MOT.0000000000000850DOI Listing
April 2021

Keeping the lights on: Telehealth, testing, and 6-month outcomes for orthotopic liver transplantation during the COVID-19 pandemic.

Surgery 2021 06 13;169(6):1519-1524. Epub 2021 Jan 13.

Cincinnati Research on Outcomes and Safety in Surgery (CROSS) Research Group, Department of Surgery, University of Cincinnati, Cincinnati, OH. Electronic address:

Background: The coronavirus disease 2019 (COVID-19) pandemic has seen transplant volume decrease nationwide, resulting in a 2.2-fold increase in waitlist mortality. In particular, solid organ transplant patients are subjected to increased morbidity and mortality from infection. In the face of these challenges, transplant centers need to develop innovative protocols to ensure high-quality care.

Methods: A multidisciplinary protocol was developed that included the following: virtual selection meetings, coronavirus disease 2019 negative donors, pretransplant symptom screening, rapid testing on presentation, telehealth follow-up, and weekly community outreach town halls. All orthotopic liver transplants completed between January 2018 and August 2020 were included in the study (n = 344). The cohort was stratified from January 2018 to February 2020 as "pre-COVID-19," and from March 2020 to August 2020 as "COVID-19." Patient demographics and postoperative outcomes were compared.

Results: From March 2020 to August 2020, there was a significant decrease in average monthly referrals for orthotopic liver transplantation (29.8 vs 37.1, P = .01). However, listings (11.0 vs 14.3, P = .09) and transplant volume remained unchanged (12.2 vs 10.6, P = .26). Rapid testing was utilized on arrival for transplant, zero patients tested positively preoperatively, and median time from test result until abdominal incision was 4.5 h [interquartile range, 1.2, 9.2]. Simultaneously, telehealth visits increased rapidly, peaking at 85% of all visits. It is important to note that there was no difference in outcomes between cohorts.

Conclusion: Orthotopic liver transplant can be accomplished safely and effectively in the COVID-19 era without compromising outcomes through increasing utilization of telehealth, rapid COVID-19 testing, and multidisciplinary protocols for managing immunosuppressed patients.
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http://dx.doi.org/10.1016/j.surg.2020.12.044DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7833561PMC
June 2021

Impact of the COVID-19 Pandemic on Lung Cancer Screening Program and Subsequent Lung Cancer.

J Am Coll Surg 2021 04 17;232(4):600-605. Epub 2020 Dec 17.

Cincinnati Research in Outcomes and Safety in Surgery (CROSS), Department of Surgery, University of Cincinnati College of Medicine, Cincinnati, OH; Division of Thoracic Surgery, University of Cincinnati College of Medicine, Cincinnati, OH.

Background: Low-dose CT (LDCT) screening reduces lung cancer mortality by at least 20%. The COVID-19 pandemic required an unprecedented shutdown in our institutional LDCT program. The purpose of this study was to examine the impact of COVID-19 on lung cancer screening and subsequent cancer diagnosis.

Study Design: We analyzed our prospective institutional LDCT screening database, which began in 2012. In all, 2,153 patients have participated. Monthly mean number of LDCTs were compared between baseline (January 2017 to February 2020) and COVID-19 periods (March 2020 to July 2020).

Results: LDCT was suspended on March 13, 2020 and 818 screening visits were cancelled. Phased reopening began on May 5, 2020 and full opening on June 1, 2020. Total monthly mean ± SD LDCTs (146 ± 31 vs 39 ± 40; p < 0.01) and new patient monthly LDCTs (56 ± 14 vs 15 ± 17; p < 0.01) were significantly decreased during the COVID-19 period. New patient monthly LDCTs have remained low despite resuming full operations. Three- and 6-month interval follow-up LDCTs were prioritized and were significantly increased compared with baseline (11 ± 4 vs 30 ± 4; p < 0.01). The "no-show" rate was significantly increased from baseline (15% vs 40%; p < 0.04). Most concerning, the percentage of patients with lung nodules suspicious for malignancy (Lung-RADS 4) were significantly increased after screenings resumed (8% vs 29%; p < 0.01).

Conclusions: COVID-19 caused significant disruption in lung cancer screening, leading to a decrease in new patients screened and an increased proportion of nodules suspicious for malignancy once screening resumed. Using lung cancer and the LDCT screening program as a model, this early analysis showed the unrecognized consequences related to the pandemic for screening programs and cancer care.
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http://dx.doi.org/10.1016/j.jamcollsurg.2020.12.002DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7947221PMC
April 2021

Lack of National Adoption of Evidence-Based Treatment for Resectable Gastric Adenocarcinoma.

J Gastrointest Surg 2021 01 17;25(1):36-47. Epub 2020 Nov 17.

Cincinnati Research on Outcomes and Safety in Surgery (CROSS), Cincinnati, OH, USA.

Background: Level 1 evidence for multimodal treatment of resectable gastric adenocarcinoma from the Intergroup 0116 (2001) and MAGIC (2006) trials demonstrated survival benefit of adjuvant chemoradiation (CRT) and perioperative chemotherapy, respectively. We evaluated the adoption of evidence-based treatment in the post-MAGIC era and its impact on survival.

Methods: A total of 7058 patients with resectable gastric adenocarcinoma undergoing definitive surgical resection between 2004 and 2015 were analyzed using the National Cancer Database.

Results: Over the study period, the proportion of patients receiving adjuvant CRT decreased from 19.1% to 9.1%, while perioperative chemotherapy increased from 1.9% to 28.6%. Utilization of perioperative chemotherapy surpassed adjuvant CRT in 2011. Evidence-based treatment (either perioperative chemotherapy or adjuvant CRT) had better overall survival (OS) than other treatments for clinical stage II-III patients (p < 0.05). On multivariate analysis of the whole study period, evidence-based treatments were associated with better OS (HR 0.67 [0.60-0.74], p < 0.05). Only 360/1262 (28.5%) patients in the perioperative chemotherapy group completed postoperative therapy, which was associated with improved OS (p < 0.05). For clinical stage III patients (n = 2402), only 806 (33.6%) received evidence-based treatment, while 487 (22.2%) underwent surgery alone. On multivariate analysis of these patients between 2010 and 2015, both perioperative chemotherapy (HR 0.49 [0.35-0.68]) and adjuvant CRT (HR 0.31 [0.21-0.44]) were associated with better OS than surgery alone (p < 0.05).

Conclusions: Since the INT-0116 and MAGIC trials, utilization of evidence-based treatments for resectable gastric adenocarcinoma has increased, with perioperative chemotherapy surpassing adjuvant CRT as the preferred practice. However, overall utilization of these regimens remains quite low nationally despite association with improved OS.
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http://dx.doi.org/10.1007/s11605-020-04868-0DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7670838PMC
January 2021

Impact of side-to-side cavocavostomy versus traditional piggyback implantation in liver transplantation.

Surgery 2020 12 1;168(6):1060-1065. Epub 2020 Sep 1.

Department of Surgery, University of Cincinnati College of Medicine, Cincinnati, OH.

Background: Traditional piggyback implantation has often been used in liver transplant; however, this technique may be hindered by difficult visualization and postoperative incidences of outflow obstruction. Side-to-side cavocavostomy is an alternative approach, but perioperative outcomes associated with this technique remain largely unknown.

Methods: In July 2017, side-to-side cavocavostomy was adopted as the standard implantation technique at our institution by all surgeons (n = 4). A prospective cohort of patients undergoing liver transplant with side-to-side cavocavostomy after July 2017 until October 2018 was compared with a historical cohort of patients who underwent liver transplant with traditional piggyback previously from January 2016 to October 2018.

Results: Of 290 liver transplant patients, 50% (n = 145) underwent side-to-side cavocavostomy, while the remainder underwent traditional piggyback. There were no differences in recipient age, sex, race, Model for End-Stage Liver Disease score, or donor characteristics between groups. Side-to-side cavocavostomy was associated with decreased mean number intraoperative, red blood cell transfusions (2 vs 5 units), fresh frozen plasma (5 vs 10 units), cell saver (1.0 vs 2.0 L), and rates of temporary abdominal closure (8.3% vs 24.1%) compared with traditional piggyback (all P < .05). The side-to-side cavocavostomy group had lesser Rt3s of postoperative transfusion rates of red blood cells (21.4% vs 35.9%; P = .01).

Conclusion: Side-to-side cavocavostomy may be superior to traditional piggyback implantation with regard to technical ease and perioperative transfusion requirements. To determine the optimal implantation technique, futures studies should evaluate side-to-side cavocavostomy versus traditional piggyback in a prospective, multicenter, randomized approach.
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http://dx.doi.org/10.1016/j.surg.2020.07.041DOI Listing
December 2020

Choices of Therapeutic Strategies for Colorectal Liver Metastases Among Expert Liver Surgeons: A Throw of the Dice?

Ann Surg 2020 11;272(5):715-722

Department of Radiology, University Hospital Zurich, Zurich, Switzerland.

Objective: To test the degree of agreement in selecting therapeutic options for patients suffering from colorectal liver metastasis (CRLM) among surgical experts around the globe.

Summary/background: Only few areas in medicine have seen so many novel therapeutic options over the past decades as for liver tumors. Significant variations may therefore exist regarding the choices of treatment, even among experts, which may confuse both the medical community and patients.

Methods: Ten cases of CRLM with different levels of complexity were presented to 43 expert liver surgeons from 23 countries and 4 continents. Experts were defined as experienced surgeons with academic contributions to the field of liver tumors. Experts provided information on their medical education and current practice in liver surgery and transplantation. Using an online platform, they chose their strategy in treating each case from defined multiple choices with added comments. Inter-rater agreement among experts and cases was calculated using free-marginal multirater kappa methodology. A similar, but adjusted survey was presented to 60 general surgeons from Asia, Europe, and North America to test their attitude in treating or referring complex patients to expert centers.

Results: Thirty-eight (88%) experts completed the evaluation. Most of them are in leading positions (92%) with a median clinical experience of 25 years. Agreement on therapeutic strategies among them was none to minimal in more than half of the cases with kappa varying from 0.00 to 0.39. Many general surgeons may not refer the complex cases to expert centers, including in Europe, where they also engage in complex liver surgeries.

Conclusions: Considerable inconsistencies of decision-making exist among expert surgeons when choosing a therapeutic strategy for CRLM. This might confuse both patients and referring physicians and indicate that an international high-level consensus statements and widely accepted guidelines are needed.
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http://dx.doi.org/10.1097/SLA.0000000000004331DOI Listing
November 2020

Improving Safety Culture-To Err Is Human.

JAMA Surg 2020 10;155(10):940-941

Cincinnati Research in Outcomes and Safety in Surgery, Department of Surgery, University of Cincinnati College of Medicine, Cincinnati, Ohio.

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http://dx.doi.org/10.1001/jamasurg.2020.2860DOI Listing
October 2020

The impact of opioid use on human and health care costs in surgical patients.

Surg Open Sci 2020 Apr 11;2(2):92-95. Epub 2020 Jan 11.

Cincinnati Research in Outcomes and Safety in Surgery (CROSS), Department of Surgery, University of Cincinnati College of Medicine, Cincinnati, OH.

Background: Preoperative narcotic use impacts hospital cost and outcomes in surgical patients, but the underlying reasons are unclear.

Methods: A single-center retrospective analysis was performed on surgical patients admitted with intestinal obstruction (2010-2014). Patients were grouped into active opioid and nonopioid user cohorts. was defined as having an opioid prescription overlapping the date of admission. was defined by duration of use ≥ 90 days. Admission or intervention due to opioid-related illness was determined through consensus decision of 2 independent, blinded clinicians. Primary end point was the effect of active opioid use on hospital resource utilization.

Results: During the study period, 296 patients were admitted with a primary diagnosis of intestinal obstruction. Active opioid users accounted for 55 (18.6%) of these patients, with a median length of opioid use of 164 days (interquartile range 54-344 days). Average length of use was 164 days, with the majority of active users ( = 42, 76.4%) meeting criteria for chronic use. A subgroup analysis of active users demonstrated that opioid-related conditions were responsible for 10 admissions (18.2%) and 2 readmissions (3.6%). Among active users requiring surgical intervention, 3 procedures (21.4%) were due to opioid-related illnesses. Median hospital length of stay was 2 days longer (8 vs 6 days) and hospital costs were greater ($12,241 vs $8489) among active users ( < .05 each).

Conclusion: Active opioid users are predisposed to avoidable admissions and interventions for opioid-related illnesses. Efforts to address opioid use in the surgical population may improve patient outcomes and health care spending.
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http://dx.doi.org/10.1016/j.sopen.2019.10.001DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7391897PMC
April 2020

Perioperative thrombelastography serves as an important assessment tool of transfusion requirements during liver transplantation.

Surg Open Sci 2020 Apr 23;2(2):70-74. Epub 2020 Jan 23.

Cincinnati Research on Outcomes and Safety in Surgery (CROSS), Department of Surgery, University of Cincinnati College of Medicine, Cincinnati, OH.

Background: Thrombelastography has become increasingly used in liver transplantation. The implications of thrombelastography at various stages of liver transplantation, however, remain poorly understood. Our goal was to examine thrombelastography-based coagulopathy profiles in liver transplantation and determine whether preoperative thrombelastography is predictive of transfusion requirements perioperatively.

Methods: A retrospective review of 364 liver transplantations from January 2013 to May 2017 at a single institution was performed. Patients were categorized as hypocoagulable or nonhypocoagulable based on their preoperative thrombelastography profile. The primary outcome was intraoperative transfusion requirements.

Results: Of patients undergoing liver transplantation, 47% ( = 170) were hypocoagulable and 53% ( = 194) were nonhypocoagulable preoperatively. Hypocoagulable patients had higher transfusion requirements compared to nonhypocoagulable patients, requiring more units of packed red blood cells (7 vs 4,  < .01), fresh frozen plasma (14 vs 8,  < .01), cryoprecipitate (2 vs 1,  < .01), platelets (3 vs 2,  < .01), and cell saver (3 vs 2 L,  < .01). Additionally, these patients were more likely to receive platelets and cryoprecipitate in the first 24 hours following liver transplantation (both  < .05). No differences were found between rates of intensive care unit length of stay, 30-day readmission, or mortality.

Conclusion: Coagulation abnormalities are common among liver transplantation patients and can be identified using thrombelastography. Identification of a patient's coagulation state preoperatively aids in guiding transfusion during liver transplantation. This work serves to better direct clinicians during major surgery to improve perioperative resource utilization. Future prospective work should aim to identify specific thrombelastography values that may predict transfusion requirements.
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http://dx.doi.org/10.1016/j.sopen.2019.12.004DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7391895PMC
April 2020

Enhanced recovery protocol improves postoperative outcomes and minimizes narcotic use following resection for colon and rectal cancer.

Surg Open Sci 2019 Oct 2;1(2):74-79. Epub 2019 Jul 2.

Cincinnati Research in Outcomes and Safety in Surgery (CROSS), Department of Surgery, University of Cincinnati, Cincinnati, OH.

Background: Enhanced recovery protocols are associated with improved recovery. However, data on outcomes following the implementation of an enhanced recovery protocol in colorectal cancer are limited. We set out to study the postoperative outcomes, opioid use patterns, and cost impact for patients undergoing colon or rectal resection for cancer.

Methods: A retrospective review of all elective colorectal cancer resections from January 2015 to June 2018 at a single institution was performed. Patient demographics, operative details, and postoperative outcomes were collected. Colon and rectal patients were studied separately, with comparison of patients before and after the implementation of an enhanced recovery protocol.

Results: One hundred ninety-two patients underwent elective colorectal resection for cancer. In January 2016, an enhanced recovery protocol was implemented for all elective resections - 71 patients (33 colon and 38 rectal) underwent surgery before implementation and 121 patients (56 colon and 65 rectal) underwent surgery after implementation of the enhanced recovery protocol. There were no differences with regard to age, gender, or body mass index before or after implementation (all P > .05). For both colon and rectal cancer patients, the enhanced recovery protocol reduced time to regular diet (both P < .05) and length of stay (colon: 3 vs 4 days; rectal: 4 vs 6 days; both P < .01). Enhanced recovery protocol patients also consumed fewer total narcotics (colon: 44 vs 184 morphine milligram equivalents, P < .01; rectal: 121 vs 393 morphine milligram equivalents, P < .01).

Conclusions: Enhanced recovery protocol use reduced length of stay and narcotic use with similar total costs and no difference in 30-day complications for both colon and rectal cancer resections.
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http://dx.doi.org/10.1016/j.sopen.2019.05.007DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7391893PMC
October 2019

Cost-Effectiveness of Utilization of Hepatitis B Virus-Positive Liver Donors for HBV-Negative Transplant Recipients.

J Gastrointest Surg 2021 07 29;25(7):1760-1769. Epub 2020 Jul 29.

Cincinnati Research on Outcomes and Safety in Surgery (CROSS), Cincinnati, OH, USA.

Background: Utilization of hepatitis B virus (HBV)-infected donors represents an opportunity to expand the liver transplantation (LT) donor pool. However, benefits of accepting HBV-positive donors for HBV-negative candidates, potentially expanding the donor pool resulting in earlier transplantation, must be balanced with costs of lifelong antiviral therapy. The aim of this study was to evaluate cost-effectiveness of this strategy.

Methods: We developed a Markov model with two strategies, transplant with (1) a HBV-positive donor versus and (2) a HBV-negative donor for a HBV-negative LT candidate. A healthcare system perspective was utilized, effectiveness measured in quality-adjusted life-years, and costs in 2018 USD.

Results: In the base-case, the HBV-positive donor strategy is more effective (gain of 0.46 QALYs), but $26,159 more expensive, yielding an incremental cost-effectiveness ratio (ICER) of $57,389/QALY. However, increasing the candidate's Model for End-Stage Liver Disease score resulted in increasing cost-effectiveness, ICER of $69,507/QALY (MELD 6-10) to $47,385/QALY (MELD > 30). Results were most sensitive to antiviral cost and cost after first year of LT. In probabilistic sensitivity analysis, the HBV-positive strategy was always more effective but more expensive, with average ICER of $64,883/QALY. This strategy was highly cost-effective (ICER < $50,000/QALY) 21% of the time and cost < $100/000/QALY 94% of the time.

Conclusions: Consideration of these donors must be individualized to each candidate's severity of liver disease, associated costs, and personal preferences that impact quality of life. Expansion of the donor pool to include HBV-positive donors for appropriate recipients may be a cost-effective policy and may provide significant benefit for individual patients.
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http://dx.doi.org/10.1007/s11605-020-04759-4DOI Listing
July 2021

Omission of Adjuvant Chemotherapy in Rectal Cancer Patients with Pathologic Complete Response: a National Analysis.

J Gastrointest Surg 2021 07 29;25(7):1857-1865. Epub 2020 Jul 29.

Department of Surgery, College of Medicine, University of Cincinnati, 2123 Auburn Ave #524, Cincinnati, OH, 45219, USA.

Background: An increasing number of patients achieve a pathologic complete response (pCR) after neoadjuvant chemoradiation for locally advanced rectal cancer. Consensus guidelines continue to recommend oncologic resection followed by adjuvant chemotherapy in these patients. We hypothesize that there is significant variability in compliance with this recommendation.

Methods: The National Cancer Database was queried from 2006 to 2015 for patients with locally advanced rectal cancer who underwent neoadjuvant chemoradiation followed by oncologic resection with a pCR (ypT0N0). Hierarchical logistic regression models were used to generate risk and reliability-adjusted rates of adjuvant chemotherapy utilization in patients with pCR at each hospital.

Results: In total, 2421 pCR patients were identified. Five-year overall survival was improved in pCR patients who received adjuvant chemotherapy compared with those who did not (92 vs. 85%, p < 0.01). Multivariate analysis indicated that improvement in overall survival remained associated with adjuvant chemotherapy (HR 0.60, 95% CI 0.44-0.82, p < 0.01). The mean adjuvant chemotherapy utilization rate among hospitals was 32%. There was an upward trend in use over the past decade, but two-thirds still do not receive the recommended therapy. High chemotherapy utilizer hospitals were more likely to be academic centers (54.9 vs. 45.9%, p < 0.01) when compared with low chemotherapy utilizers.

Conclusion: Adjuvant chemotherapy is associated with improved survival in rectal cancer patients with pCR following neoadjuvant chemoradiation and oncologic resection. However, utilization among centers in the USA was only 32% with significant variability across centers. National efforts are needed to standardize treatment patterns according to national guidelines.
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http://dx.doi.org/10.1007/s11605-020-04749-6DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7388436PMC
July 2021

The road to academic surgical leadership: Characteristics and experiences of surgical chairpersons.

Surgery 2020 10 11;168(4):707-713. Epub 2020 Jul 11.

Department of Surgery, University of Cincinnati College of Medicine, OH. Electronic address:

Background: The evolving landscape of academic surgery demands leaders who are not only effective clinicians and researchers, but also administrators able to navigate complex hospital organizations, financial pressures in the era of quality measures, and inclusion of an increasingly diverse workforce. The aim of this study was to characterize achievements and assess perspectives in becoming a surgical chair in order to guide young surgeons in their career trajectories to surgical leadership.

Methods: A survey encompassing demographics, surgical training, nonmedical advanced degrees, academic advancement, and leadership experiences was sent via electronic mail to members of the American College of Surgeons Society of Surgical Chairs in December 2018.

Results: Of 191 Society of Surgical Chairs members, 52 (27.2%) completed the survey, with 6 (11.5%) women, 40 (76.9%) white, and the majority becoming chair between ages 46 and 60 (n = 39, 75.0%). Training beyond residency included fellowships (n = 41, 78.8%) and advanced nonmedical degrees (n = 15, 28.8%). Median H-index was 47 (range 10-120) with 126 (5-500) research publications, and grants received was 2 (0-38) for federal and 5 (0-43) for industry. Female chairs appear to have fewer nonmedical degrees (n = 1) and no difference in age at becoming chair (66.7% vs 79.6% between ages 46 and 60), H-index (26 [10-41] vs 49 [17-120]), or publications (93 [10-189] vs 150 [5,500]). Prior educational (n = 36, 69.2%) and clinical (n = 44, 84.6%) leadership roles were common, with 30 chairs (57.7%) having held both roles. Experiences which respondents felt have most helped them function as chair included serving as a clinical division director (n = 37, 71.2%), residency program director (n = 28, 53.8%), leadership courses (n = 28, 53.8%), a research career (n = 22, 42.3%), and being a vice/interim chair (n = 15, 28.8%). Personal traits felt to be most important in becoming a successful chair included being effective at communication (n = 37, 71.2%), collaborative (n = 35, 67.3%), trustworthy (n = 30, 57.7%), and a problem-solver (n = 27, 51.9%).

Conclusion: Becoming a department surgical chair often involves not only surgical subspecialty expertise, but also nonmedical training and prior leadership roles, which help facilitate development of skills integral to navigating the collaborative and diverse nature of academic surgery in the current era.
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http://dx.doi.org/10.1016/j.surg.2020.05.022DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7541787PMC
October 2020

A call to action: Feasible strategies to reduce the discard of transplantable kidneys in the United States.

Clin Transplant 2020 09 4;34(9):e13990. Epub 2020 Jul 4.

Department of Surgery, School of Medicine, University of Iowa, Iowa City, Iowa, USA.

Changes to the United States kidney allocation system targeted at reducing organ discard have failed to improve organ utilization. High Kidney Donor Profile Index kidneys continue to be discarded at high rates as a result of the regulatory and financial barriers to widespread utilization of these organs. However, there are potential changes to clinical practice that could improve organ utilization. Expediting the time from initial offer to final organ acceptance would reduce cold ischemic time and should improve utilization. Implementation of procurement biopsy standards to avoid biopsy of low risk organs may prevent organ discards due to inaccurate data or excessive cold ischemia time. Further, standardization of procurement biopsy pathological interpretation coupled with electronic accessibility would enable early acceptance of difficult to transplant organs. These changes to allocation practice patterns are vital given proposals to expand the geographic sharing of deceased donor kidneys. Implementation of new allocation policies must be evaluated to ensure they result in higher transplant rates and acceptable post-transplant outcomes.
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http://dx.doi.org/10.1111/ctr.13990DOI Listing
September 2020

Safety and Efficacy of Budesonide for Liver Transplant Immune Suppression: Results of a Pilot Phase 2a Trial.

Liver Transpl 2020 11 19;26(11):1430-1440. Epub 2020 Aug 19.

Divisions of, Division of, Digestive Diseases, University of Cincinnati, Cincinnati, OH.

Despite adverse effects like hyperglycemia, new-onset diabetes after transplant (NODAT), and infectious complications, corticosteroid use remains an important part of liver transplantation (LT) immune suppression. Budesonide, a synthetic corticosteroid, undergoes extensive first-pass hepatic metabolism with only 10% systemic bioavailability, providing an opportunity for an improved toxicity-therapeutic ratio. Although effective in the treatment of autoimmune hepatitis, the effects of budesonide for LT immune suppression are unknown. We conducted a single-center phase 2a trial to study the safety and efficacy of budesonide immunosuppressive therapy. From July 2017 to November 2018, 20 patients undergoing a first LT received budesonide tapering doses (from 9 to 3 mg) for 12 weeks. Patients were compared with matched control patients who received prednisone from the same time period. Additionally, both groups received calcineurin inhibitors and mycophenolate mofetil. Outcome measures at week 24 included rates of biopsy-proven acute cellular rejection (ACR), NODAT (hemoglobin A1c >6.4%), and infectious complications. In the budesonide arm, 1 patient developed ACR at week 5 and was removed from the study. Another patient stopped the study drug at week 8 due to persistent nausea. Rates of ACR were similar between the budesonide and control groups (5% versus 5%, P = 1.00). Three patients in the control group developed NODAT versus none in the budesonide group (15% versus 0%; P = 0.23). There were 6 infections in the control group compared with none in the budesonide group (30% versus 0; P = 0.02). These pilot data suggest that budesonide has the potential to be a safe and effective alternative to prednisone for LT immune suppression while reducing steroid-induced infections and NODAT. Randomized controlled trials are required to validate these findings.
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http://dx.doi.org/10.1002/lt.25837DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7606621PMC
November 2020

Opioid Minimization After Liver Transplantation: Results of a Novel Pilot Study.

Liver Transpl 2020 09;26(9):1188-1192

Cincinnati Research on Outcomes and Safety in Surgery, Department of Surgery.

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http://dx.doi.org/10.1002/lt.25829DOI Listing
September 2020

Current status of liver transplantation in North America.

Int J Surg 2020 Oct 28;82S:9-13. Epub 2020 May 28.

Department of Surgery, University of Cincinnati College of Medicine, USA. Electronic address:

Liver transplantation is continuing to grow and evolve in North America. Changes in organ availability, recipient selection, indications and progressive approaches to oncologic treatment have occurred in the last five years. Despite increased activity in deceased and living donation in North America, there continues to be a high mortality on the waitlist as the recipient indications have changed over time which has led to new approaches to help patients with end-stage liver disease.
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http://dx.doi.org/10.1016/j.ijsu.2020.05.059DOI Listing
October 2020

Use of Hepatitis C Nucleic Acid Test-Positive Liver Allografts in Hepatitis C Virus Seronegative Recipients.

Liver Transpl 2020 05;26(5):673-680

Solid Organ Transplantation, Department of Surgery, University of Cincinnati College of Medicine, Cincinnati, OH.

Because of underutilization of liver allografts, our center previously showed that hepatitis C virus (HCV) antibody-positive/nucleic acid test (NAT)-negative livers when transplanted into HCV nonviremic recipients were safe with a 10% risk of HCV transmission. Herein, we present our single-center prospective experience of using HCV NAT+ liver allografts transplanted into HCV NAT- recipients. An institutional review board-approved matched cohort study was conducted examining post- liver transplantation (LT) outcomes of HCV- patients who received HCV NAT+ organs (treatment group) compared with matched recipients with HCV NAT- organs (matched comparator group) between June 2018 to October 2019. The primary endpoint was success of HCV treatment and elimination of HCV infection. The secondary outcomes included the 30-day and 1-year graft and patient survival as well as perioperative complications. There were 32 recipients enrolled into each group. Because of 1 death in the index admission, 30/31 patients (97%) were given HCV treatment at a median starting time of 47 days (18-140 days) after LT. A total of 19 (63%) patients achieved sustained virological response at week 12 (SVR12). Another 6 patients achieved end-of-treatment response, while 5 remained on therapy and 1 is yet to start treatment. No HCV treatment failure has been noted. There were no differences in 30-day and 1-year graft and patient survival, length of hospital stay, biliary or vascular complications, or cytomegalovirus viremia between the 2 groups. In this interim analysis of a matched cohort study, which is the first and largest study to date, the patients who received the HCV NAT+ organs had similar outcomes regarding graft function, patient survival, and post-LT complications.
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http://dx.doi.org/10.1002/lt.25741DOI Listing
May 2020

Hepatic Deficiency of Augmenter of Liver Regeneration Predisposes to Nonalcoholic Steatohepatitis and Fibrosis.

Hepatology 2020 11 22;72(5):1586-1604. Epub 2020 Oct 22.

Division of Gastroenterology, Hepatology and Nutrition, Department of Pediatrics, Cincinnati Children's Hospital Medical Center, Cincinnati, OH.

Background And Aims: The augmenter of liver regeneration (ALR) protein is critical for lipid homeostasis and mitochondrial function. We investigated high-fat/high-carbohydrate (HF/HC) diet-induced nonalcoholic fatty liver disease (NAFLD) in wild-type (WT), hepatocyte-specific ALR-knockout (ALR-H-KO), and ALR-heterozygous (ALR-H-HET) mice. ALR was measured in serum of human nonalcoholic steatohepatitis (NASH) and NASH-induced cirrhosis (serum and liver).

Approach And Results: HF/HC feeding decreased ALR expression in all groups of mice. The otherwise normal ALR-H-HET mice gained more weight and steatosis than WT mice when challenged metabolically with the HF/HC diet; ALR-H-KO mice gained the least weight and had the least steatosis. These findings were consistent with correspondingly increased triglycerides and cholesterol and altered expression of carnitine palmitoyltransferase 1a, sterol regulatory element-binding protein, acetyl coenzyme A carboxylase, and fatty acid synthase. All HF/HC-fed mice developed insulin resistance, the magnitude being lower in ALR-H-KO mice. HF/HC-fed ALR-H-HET mice were more resistant to glucose challenge than WT or ALR-H-KO mice. The frequency of tumor necrosis factor alpha-producing, interleukin 6 (IL6)-producing, and IL17-producing cells was greater in ALR-H-KO than ALR-H-HET and lowest in WT mice. HF/HC feeding did not increase their number in ALR-H-KO mice, and the increase in ALR-H-HET was greater than that in WT mice except for IL17 cells. Cluster of differentiation 25-positive (CD25 ) forkhead box P3-positive CD4 regulatory T-cell frequency was lower in ALR-H-HET than WT mice and further reduced in ALR-H-KO mice; HF/HC reduced regulatory T-cell frequency only in WT mice. HF/HC-fed ALR-H-HET, but not WT, mice developed fibrosis; and ALR-H-KO mice progressed to cirrhosis. White adipose tissue of HF/HC-fed ALR-deficient mice developed strong inflammation, indicating bidirectional interactions with the liver. Hepatic and serum ALR levels were significantly reduced in patients with NASH-cirrhosis. Serum ALR was also significantly lower in patients with NASH.

Conclusions: Hepatic ALR deficiency may be a critical predisposing factor for aggressive NAFLD progression.
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http://dx.doi.org/10.1002/hep.31167DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8025692PMC
November 2020

Recurrent hepatocellular carcinoma: Different strategies, same endpoint.

Surgery 2021 04 25;169(4):921. Epub 2019 Nov 25.

Department of Surgery, University of Cincinnati College of Medicine, Cincinnati, OH. Electronic address:

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http://dx.doi.org/10.1016/j.surg.2019.10.003DOI Listing
April 2021

Outcome of delayed versus timely esophagectomy after chemoradiation for esophageal adenocarcinoma.

J Thorac Cardiovasc Surg 2020 06 22;159(6):2555-2566. Epub 2019 Oct 22.

Cincinnati Research in Outcomes and Safety in Surgery (CROSS), Department of Surgery, University of Cincinnati College of Medicine, Cincinnati, Ohio; Division of Thoracic Surgery, Department of Surgery, University of Cincinnati College of Medicine, Cincinnati, Ohio. Electronic address:

Background: Salvage and delayed esophagectomy after chemoradiation therapy (CRT) have been associated with increased morbidity and mortality, but recent series have shown similar outcomes compared to timely esophagectomy. We aim to evaluate outcomes for delayed and salvage esophagectomy for esophageal adenocarcinoma utilizing a large national database.

Methods: The National Cancer Database for 2004 to 2014 was queried for patients with clinical stage II or III esophageal adenocarcinoma who underwent preoperative CRT and esophagectomy. Patients who underwent surgery <90 days after CRT were defined as the timely esophagectomy group (n = 7822), and those who underwent surgery ≥90 days after CRT were defined as the delayed esophagectomy group (n = 667).

Results: A total of 8489 patients met our inclusion criteria. The median post-CRT interval was 49 days (range, 40-61 days) for the timely esophagectomy group and 109 days (range, 97-132 days) for the delayed esophagectomy group. The delayed group was more likely to be of black race (2.3% vs 1.2%; P < .01) and more likely to have Medicare (47.9% vs 39.8%; P < .001). There were no significant between-group differences in chemotherapy regimens (P = .17), radiation dose (P = .18), or surgical approach (P = .48). The delayed esophagectomy group had higher rates of pathological complete response (22.2% vs 18.6%; P = .043) and 90-day postoperative mortality (10.4% vs 7.8%; P < .01). On multivariate analysis, delayed esophagectomy was not independently associated with decreased overall survival.

Conclusions: In this large retrospective database study, despite increased perioperative mortality, delayed and salvage esophagectomy for adenocarcinoma appear to have similar long-term survival as timely esophagectomy. Delayed and salvage esophagectomy may be offered to patients who do not receive timely esophagectomy after CRT.
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http://dx.doi.org/10.1016/j.jtcvs.2019.09.169DOI Listing
June 2020
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