Research Spotlight

Posted March 15th 2022

Nutritional Support and Duration of Drainage Recommendations for Endoscopic Internal Drainage: Review of the Literature and Initial Experience.

Steven G. Leeds M.D.

Steven G. Leeds M.D.

Leeds, S. G., Whitfield, E. P., Ogola, G. and Ward, M. A. (2022). “Nutritional Support and Duration of Drainage Recommendations for Endoscopic Internal Drainage: Review of the Literature and Initial Experience.” Obes Surg.

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INTRODUCTION: Anastomotic leaks following foregut surgery pose a difficult scenario for surgeons. While definitive surgical options are more invasive and may result in diversion requiring subsequent surgeries, endoscopic management of these leaks has been shown to work as an alternative platform for management. An evolving option is endoscopic internal drainage. We have reviewed our experience using endoscopic internal drainage and report our outcomes. MATERIALS AND METHODS: An institution review board approved prospectively gathered database was used to identify all patients undergoing endoscopic internal drainage following esophageal and gastric leaks. Patient demographics, sentinel operation causing the leak, and outcomes of therapy were collected. The rate of healing and complications with the drainage catheter in place were the primary endpoints. RESULTS: Sixteen patients were identified (5 male, 11 female) that underwent endoscopic internal drainage with a mean age of 48 and mean BMI of 30.8. Overall success rate was 69% (11/16), where 4 patients required a definitive surgery, and one healed with endoluminal vacuum therapy. Of the 4 failures, 1 patient required esophagojejunostomy, 2 patients required a fistulojejunostomy, and one required a partial gastrectomy. A total of 12 patients (75%) had a prior endoscopic procedure that was unsuccessful. The mean duration of drainage catheter in place was 48 days. While the catheter was in place, 4 patients were allowed minimal PO intake in conjunction with total parenteral nutrition or tube feeds. The rest of the patients were strict NPO with other means of nutrition. There were no complications with the drainage catheters and no deaths. CONCLUSION: Leaks following esophagogastric surgery are difficult to manage; however, endoscopic internal drainage has been shown to be effective. Duration of the technique should be around 6 to 8 weeks with nutritional support guided by the comfort of the managing clinician.


Posted March 15th 2022

Oncology Trainee Perceptions of the Prior Authorization Process: A National Survey.

Prashant Gabani, M.D.

Prashant Gabani, M.D.

Kim, H., Srivastava, A., Gabani, P., Kim, E., Lee, H. and Pedersen, K. S. (2022). “Oncology Trainee Perceptions of the Prior Authorization Process: A National Survey.” Adv Radiat Oncol 7(2): 100861.

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PURPOSE: The medical trainee perspective regarding the prior authorization process has not been previously assessed. Here we evaluate the perceptions of radiation and medical oncology trainees regarding the prior authorization process and its effect on their training and patient care. METHODS AND MATERIALS: A 12-question, nonincentivized, electronic national survey of radiation and medical oncology trainees at all Accreditation Council for Graduate Medical Education accredited oncology programs was conducted. Participation, perspectives, and experiences with the prior authorization process were assessed by Likert scale, free response, and multiple response selection. RESULTS: Between January and March of 2019, the survey was distributed to 1505 trainees at 76 institutions with responses from 174/616 radiation (28.2%) and 139/889 medical oncology trainees (15.6%). The majority (69.2%) reported participating in the prior authorization process (radiation: 78.2% vs medical: 57.6%; P < .01). Most trainees (71%) reported concern for decline in the quality of patient care due to the prior authorization process. The majority of trainees (77.1%) reported decreased enthusiasm for work and choice of profession, with a higher incidence in medical oncology trainees (83.1% vs 73.7%, P = .04). The most commonly recommended modifications by trainees included that the insurance reviewer be in the same specialty as the ordering provider (87.7%), providers be compensated for participation (82.7%), and turnaround time be more rapid (74.3%). CONCLUSIONS: These data indicate that trainees in US oncology programs are active participants in the prior authorization process and report that prior authorization approvals negatively influence their medical training and the quality of patient care. Additional efforts to revise the insurance approval process are warranted.


Posted March 15th 2022

Evaluation of aerosolized epoprostenol for hypoxemia in non-intubated patients with coronavirus disease 2019.

Vivek Kataria, Pharm.D.

Vivek Kataria, Pharm.D.

Kataria, V., Ryman, K., Tsai-Nguyen, G., Wakwaya, Y. and Modrykamien, A. (2022). “Evaluation of aerosolized epoprostenol for hypoxemia in non-intubated patients with coronavirus disease 2019.” Hosp Pract (1995).

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OBJECTIVES: Patients infected with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) frequently present with a febrile illness that may progress to pneumonia and hypoxic respiratory failure. Aerosolized epoprostenol (aEPO) has been evaluated in patients with acute respiratory distress syndrome and refractory hypoxemia. A paucity of literature has assessed the impact of aEPO in patients with SARS-CoV-2 receiving oxygen support with high flow nasal cannula (HFNC). The objective of this study was to evaluate whether aEPO added to HFNC prevents intubation and/or prolong time to intubation compared to controls only treated with HFNC, guided by oxygen saturation goals. METHODS: This was a single-center, retrospective study with adult patients infected with coronavirus 2019 (COVID-19) and admitted to the medical intensive care unit. A total of 60 patients were included. Thirty patients were included in the treatment, and thirty in the control group, respectively. Among patients included in the treatment group, response to therapy was assessed. Need of mechanical ventilation and hospital mortality between responders vs. non-responders was evaluated. RESULTS: The primary outcome of mechanical ventilation was not statistically different between groups. Time from HFNC initiation to intubation was significantly prolonged in the treatment group compared to the control group (5.7 days vs. 2.3 days, P = 0.001). There was not a statistically significant difference between groups in mortality or length of stay. Patients deemed responders to aEPO had a lower rate of mechanical ventilation (50% vs 88%, P = 0.025) and mortality (21% vs 63%, P = 0.024), compared with non-responders. CONCLUSION: The utilization of aEPO in COVID-19 patients treated with HFNC is not associated with a reduction in the rate of mechanical ventilation. Nevertheless, the application of this strategy may prolong the time to invasive mechanical ventilation, without affecting other clinical outcomes.


Posted March 15th 2022

Risk Factors for Hepatocellular Cancer in Contemporary Cohorts of Patients with Cirrhosis.

Sumeet K. Asrani M.D.

Sumeet K. Asrani M.D.

Kanwal, F., Khaderi, S., Singal, A. G., Marrero, J. A., Loo, N., Asrani, S. K., Amos, C. I., Thrift, A. P., Gu, X., Luster, M., Al-Sarraj, A., Ning, J. and El-Serag, H. B. (2022). “Risk Factors for Hepatocellular Cancer in Contemporary Cohorts of Patients with Cirrhosis.” Hepatology.

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BACKGROUND & AIMS: Etiological risk factors for cirrhosis have changed in the last decade. It remains unclear to what extent these trends in cirrhosis risk factors have changed hepatocellular cancer (HCC) risk. APPROACH & RESULTS: We used data from two contemporary, prospective multiethnic cohorts of patients with cirrhosis: the Texas Hepatocellular Carcinoma Consortium Cohort and the Houston Veterans Administration Cirrhosis Surveillance Cohort. Patients with cirrhosis were enrolled from seven U.S. centers and followed until HCC diagnosis, transplant, death or June 30, 2021. We calculated the annual incidence rates for HCC and examined the effects of etiology, demographic, clinical, and lifestyle factors on the risk of HCC. We included 2733 patients with cirrhosis (mean age 60.1 years, 31.3% women). At enrollment, 19.0% had active HCV, 23.3% cured HCV, 16.1% had alcoholic liver disease, and 30.1% had nonalcoholic fatty liver disease (NAFLD). During 7,406 person-years follow up, 135 patients developed HCC at an annual incidence rate of 1.82% (95% confidence interval [CI]=1.51-2.13). The annual HCC incidence rate was 1.71% in patients with cured HCV, 1.32% in patients with alcoholic liver disease, and 1.24% in patients with NAFLD cirrhosis. Compared to patients with NAFLD, the risk of progression to HCC was 2-fold higher in patients with cured HCV (hazard ratio [HR]=2.04, 95% CI, 1.24-3.35). Current smoking (HR=1.63, 95%CI, 1.01-2.63) and overweight/obesity (HR=1.79, 95% CI 1.08, 2.95) were also associated with HCC risk. CONCLUSIONS: HCC incidence among patients with cirrhosis was lower than previously reported. HCC risk was variable across etiologies, with higher risk in patients with HCV cirrhosis and lower in those with NAFLD cirrhosis. Current smoking and overweight/obesity increased HCC risk across etiologies.


Posted March 15th 2022

Practice Patterns and Outcomes of Transcatheter Aortic Valve Replacement in the United States and Japan: A Report From Joint Data Harmonization Initiative of STS/ACC TVT and J-TVT.

Michael J. Mack M.D.

Michael J. Mack M.D.

Kaneko, T., Vemulapalli, S., Kohsaka, S., Shimamura, K., Stebbins, A., Kumamaru, H., Nelson, A. J., Kosinski, A., Maeda, K., Bavaria, J. E., Saito, S., Reardon, M. J., Kuratani, T., Popma, J. J., Inohara, T., Thourani, V. H., Carroll, J. D., Shimizu, H., Takayama, M., Leon, M. B., Mack, M. J. and Sawa, Y. (2022). “Practice Patterns and Outcomes of Transcatheter Aortic Valve Replacement in the United States and Japan: A Report From Joint Data Harmonization Initiative of STS/ACC TVT and J-TVT.” J Am Heart Assoc: e023848.

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Background The practice pattern and outcome of medical devices following their regulatory approval may differ by country. The aim of this study is to compare postapproval national clinical registry data on transcatheter aortic valve replacement between the United States and Japan on patient characteristics, periprocedural outcomes, and the variability of outcomes as a part of a partnership program (Harmonization-by-Doing) between the 2 countries. Methods and Results The patient-level data were extracted from the US Society of Thoracic Surgeons /American College of Cardiology Transcatheter Valve Therapy (STS/ACC TVT) and the J-TVT (Japanese Transcatheter Valvular Therapy) registry, respectively, to analyze transcatheter aortic valve replacement outcomes between 2013 and 2019. Data entry for these registries was mandated by the federal regulators, and the majority of variable definitions were harmonized to allow direct data comparison. A total of 244 722 transcatheter aortic valve replacements from 646 institutions in the United States and 26 673 transcatheter aortic valve replacements from 171 institutions in Japan were analyzed. Median volume per site was 65 (interquartile range, 45-97) in the United States and 28 (interquartile range, 19-41) in Japan. Overall, patients in J-TVT were older (United States: mean-age, 80.1±8.7 versus Japan: 84.4±5.2; P<0.001), were more frequently women (45.9% versus 68.1%; P<0.001), and had higher median Society of Thoracic Surgeons Predicted Risk of Mortality (5.27% versus 6.20%; P<0.001) than patients in the United States. Japan had lower unadjusted 30-day mortality (1.3% versus 3.2%; P<0.001) and composite outcomes of death, stroke, and bleeding (17.5 versus 22.5%; P<0.001) but had higher conversion to open surgery (0.94% versus 0.56%; P<0.001). Conclusions This collaborative analysis between the United States and Japan demonstrated the feasibility of international comparison using the national registries coded under mutual variable definitions. Both countries obtained excellent outcomes, although the Japanese had lower 30-day mortality and major morbidity. Harmonization-by-Doing is one of the key steps needed to build global-level learning to improve patient outcomes.