Publications by authors named "Dimitrios Giannis"

50 Publications

Pneumomediastinum in the COVID-19 era: to drain or not to drain?

Monaldi Arch Chest Dis 2022 Jul 27. Epub 2022 Jul 27.

Thoracic Surgery Department, University College London Hospitals, NHS Foundation Trust, London, UK..

Pneumomediastinum (PNM) is a rare clinical finding, usually with a benign course, which is managed conservatively in the majority of cases. However, during the COVID-19 pandemic, an increased incidence of PNM has been observed. Several reports of PNM cases in COVID-19 have been reported in the literature and were managed either conservatively or surgically. In this study, we present our institutional experience of COVID-19 associated PNM, propose a management algorithm, and review the current literature. In total, 43 Case Series were identified, including a total of 747 patients, of whom 374/747 (50.1%) were intubated at the time of diagnosis, 168/747 (22.5%) underwent surgical drain insertion at admission, 562/747 (75.2%) received conservative treatment (observation or mechanical ventilation. Inpatient mortality was 51.8% (387/747), while 45.1% of the population recovered and/or was discharged (337/747). In conclusion, with increased incidence of PNM in COVID-19 patients reported in the literature, it is still difficult to assign a true causal relationship between PNM and mortality. We can, however, see that PMN plays an important role in disease prognosis.  Due to increased complexity, high mortality, and associated complications, conservative management may not be sufficient, and a surgical approach is needed.
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http://dx.doi.org/10.4081/monaldi.2022.2338DOI Listing
July 2022

Circulating microRNAs and Clinicopathological Findings of Papillary Thyroid Cancer: A Systematic Review.

In Vivo 2022 Jul-Aug;36(4):1551-1569

Department of General and Endocrine Surgery, University College London Hospitals, London, U.K.

Background/aim: Papillary thyroid cancer (PTC) is the most common endocrine malignancy with a rising incidence. There is a need for a non-invasive preoperative test to enable better patient counselling. The aim of this systematic review was to investigate the potential role of circulating microRNAs (miRNAs) in the diagnosis and prognosis of PTC.

Materials And Methods: A systematic literature search was performed using MEDLINE, Cochrane, and Scopus databases (last search date was December 1, 2021). Studies investigating the expression of miRNAs in the serum or plasma of patients with PTC were deemed eligible for inclusion.

Results: Among the 1,533 screened studies, 39 studies met the inclusion criteria. In total, 108 miRNAs candidates were identified in the serum, plasma, or exosomes of patients suffering from PTC. Furthermore, association of circulating miRNAs with thyroid cancer-specific clinicopathological features, such as tumor size (13 miRNAs), location (3 miRNAs), extrathyroidal extension (9 miRNAs), pre- vs. postoperative period (31 miRNAs), lymph node metastasis (17 miRNAs), TNM stage (9 miRNAs), BRAF V600E mutation (6 miRNAs), serum thyroglobulin levels (2 miRNAs), I avid metastases (13 miRNAs), and tumor recurrence (2 miRNAs) was also depicted in this study.

Conclusion: MiRNAs provide a potentially promising role in the diagnosis and prognosis of PTC. There is a correlation between miRNA expression profiles and specific clinicopathological features of PTC. However, to enable their use in clinical practice, further clinical studies are required to validate the predictive value and utility of miRNAs as biomarkers.
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http://dx.doi.org/10.21873/invivo.12866DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC9301440PMC
June 2022

Trends in Primary Gallbladder Cancer Incidence and Incidence-based Mortality in the United States, 1973 to 2015.

Am J Clin Oncol 2022 07 19;45(7):306-315. Epub 2022 May 19.

School of Tropical Medicine and Global Health, Nagasaki University, Japan.

Objectives: Primary gallbladder cancer (GBC) is the most common biliary tract cancer with poor survival despite aggressive treatment. This study aimed to investigate the trends of GBC incidence and incidence-based mortality (IBM) over the last 4 decades.

Materials And Methods: GBC cases diagnosed between 1973 and 2015 were retrieved from the Surveillance, Epidemiology, and End Results (SEER) database. Incidence rates, IBM rates, and annual percent changes (APCs) were calculated and stratified according to population and tumor characteristics.

Results: The cohort consisted of 10,792 predominantly white (81%) and female (71%) GBC patients. The overall GBC incidence decreased by 1.65% (95% confidence interval [CI]: 1.45% to 1.84%) per year since 1973, but has plateaued since 2002. IBM decreased by 1.69% (95% CI: 1.22% to 2.16%) per year from 1980 to 2015; the rate of decrease in IBM rates was lower during 1997 to 2015 (APC: -1.19%, 95% CI: -1.68% to -0.71%) compared with 1980 to 1997 (APC: -3.13%, 95% CI: -3.68% to -2.58%).

Conclusions: The incidence and IBM rates of GBC have been decreasing over the last 40 years, but the decrease plateaued over the last 2 decades. The effects of treatment modalities, including laparoscopic cholecystectomy, adjuvant chemotherapy, and radiation on the incidence and IBM of GBC need to be further investigated.
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http://dx.doi.org/10.1097/COC.0000000000000918DOI Listing
July 2022

Delayed intracranial hemorrhage of patients with mild traumatic brain injury under antithrombotics on routine repeat CT scan: a systematic review and meta-analysis.

Brain Inj 2022 05 27;36(6):703-713. Epub 2022 Apr 27.

Faculty of Medicine, Department of physiology, Aristotle University of Thessaloniki, Thessaloniki, Greece.

Background: Patients on antithrombotics experiencing mild traumatic brain injury (mTBI) may benefit from a routine repeat CT scan to detect delayed intracranial hemorrhage (dICH).

Objectives: The primary outcome was the incidence of dICH on routine repeat CT scans of mTBI patients on antithrombotics within an intra-hospital observation period of up to 48 hours. The secondary outcomes were potential risk factors, readmissions, neurosurgical interventions, and mortality.

Methods: A systematic review and a meta-analysis of single proportions were performed according to the PRISMA and PRESS guidelines. The risk of bias was assessed using Newcastle-Ottawa Scale.

Results: Eighteen studies with 4613 patients were included. The pooled incidence of dICH was 2% [95% CI 1-2%] with similar rates between different antithrombotic regimens, even in combination. Of the 67 patients with dICH reported (1.45%), eleven required surgery (0.24%), while six died (0.13%). Loss of consciousness was a risk factor of dICH (risk ratio 3.04 [95%CI 0.96; 9.58]). A total of 48 patients were reported for readmission without associated death or surgical intervention.

Conclusion: The contribution of this routine repeat CT scan should be questioned due to the low incidence, the limited clinical significance, and the unsubstantiated clinical benefit of early or systematic detection of dICH.
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http://dx.doi.org/10.1080/02699052.2022.2065034DOI Listing
May 2022

Autonomic Neuromodulation for Atrial Fibrillation Following Cardiac Surgery: JACC Review Topic of the Week.

J Am Coll Cardiol 2022 02;79(7):682-694

Feinstein Institutes for Medical Research at Northwell Health, Manhasset, New York, USA. Electronic address:

Autonomic neuromodulation therapies (ANMTs) (ie, ganglionated plexus ablation, epicardial injections for temporary neurotoxicity, low-level vagus nerve stimulation [LL-VNS], stellate ganglion block, baroreceptor stimulation, spinal cord stimulation, and renal nerve denervation) constitute an emerging therapeutic approach for arrhythmias. Very little is known about ANMTs' preventive potential for postoperative atrial fibrillation (POAF) after cardiac surgery. The purpose of this review is to summarize and critically appraise the currently available evidence. Herein, the authors conducted a systematic review of 922 articles that yielded 7 randomized controlled trials. In the meta-analysis, ANMTs reduced POAF incidence (OR: 0.37; 95% CI: 0.25 to 0.55) and burden (mean difference [MD]: -3.51 hours; 95% CI: -6.64 to -0.38 hours), length of stay (MD: -0.82 days; 95% CI: -1.59 to -0.04 days), and interleukin-6 (MD: -79.92 pg/mL; 95% CI: -151.12 to -8.33 pg/mL), mainly attributed to LL-VNS and epicardial injections. Moving forward, these findings establish a base for future larger and comparative trials with ANMTs, to optimize and expand their use.
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http://dx.doi.org/10.1016/j.jacc.2021.12.010DOI Listing
February 2022

Platelet rich plasma effectiveness in bowel anastomoses: A systematic review.

World J Gastrointest Surg 2021 Dec;13(12):1736-1753

Laboratory of Scientific Research and Experimental Surgery, 2nd Propedeutic Department of Surgery, School of Medicine, Aristotle University, Thessaloniki 54642, Greece.

Background: Anastomotic leak constitutes a major problem in abdominal surgery. Technical insufficiency, topical or systemic factors contribute to disrupted healing of the performed bowel anastomosis and result in anastomosis leakage, with detrimental effects on patient postoperative outcomes. Despite the investigation of several factors and the invention of protective materials, the ideal agent to prevent anastomotic leaks is yet to be determined.

Aim: To study the effect of platelet rich plasma (PRP) on the healing of bowel anastomoses.

Methods: A systematic literature search was performed in PubMed, EMBASE, and Scopus databases to identify studies investigating the effect of PRP application on bowel anastomosis.

Results: Eighteen studies were eligible with a total population of 712 animals including rats (14 studies), rabbits (2 studies) and pigs (2 studies). No postoperative complications were reported following PRP application. Fourteen out of 18 studies reported a statistically significant higher anastomosis bursting pressure in PRP groups compared to control either in healthy animals or animal models with underlying condition or intervention, such as intraperitoneal chemotherapy or peritonitis. Similar results were reported by ten studies in terms of tissue hydroxyproline levels. One study reported significant increase in collagen deposition in PRP groups. PRP application resulted in significantly decreased inflammatory cell infiltration in the presence of peritonitis or intraperitoneal chemotherapy (6 studies).

Conclusion: The application of PRP is associated with improved bowel anastomosis outcomes, especially in animal models having an underlying condition affecting the normal healing process. PRP application seems to augment the normal healing process under these circumstances. However, further studies are needed to investigate the potential role of PRP on bowel anastomosis healing, especially in clinical settings.
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http://dx.doi.org/10.4240/wjgs.v13.i12.1736DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8727194PMC
December 2021

Diagnostic Dilemma of Paraneoplastic Rheumatic Disorders: Case Series and Narrative Review.

Cureus 2021 Nov 29;13(11):e19993. Epub 2021 Nov 29.

Rheumatology, Northeast Georgia Medical Center Gainesville, Gainesville, USA.

Paraneoplastic rheumatic disorder (RD) is a disorder that may present before, concurrent with, or after the diagnosis of malignancy. Paraneoplastic RDs are a clinical expression of occult cancer that is not directly related to a tumor or metastasis and manifests as rheumatoid symptoms. The RD is determined by the organ system affected by articular, muscular, cutaneous, vascular, or miscellaneous symptoms. Each case is challenging to diagnose because cancer may present with similar symptoms as a common rheumatic disorder. Of note, the majority of cases have minimal responsiveness or no responsiveness to standard rheumatoid treatment. Therefore, it is imperative to recognize and treat the underlying cancer accordingly. Herein, we present four different diagnostic dilemma cases of RD: case #1 - leukocytoclastic vasculitis and C3 glomerulopathy, case #2 - scleroderma, case #3 - Raynaud's syndrome and possible lupus-like syndrome, and case #4 - inflammatory myositis. Institutional IRB approval was obtained for this case series. We will discuss and review the literature on each topic. In addition, we will mention a review of paraneoplastic rheumatoid arthritis. As rheumatic disease is associated with the use of immune checkpoint inhibitors (ICIs) for cancer treatment, we will briefly discuss some of the most common rheumatic presentations in the setting of these drugs. This case review aims to inform clinicians about the atypical presentation of paraneoplastic RD and to highlight the need for interdisciplinary management between rheumatologists, oncologists, and primary care practitioners.
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http://dx.doi.org/10.7759/cureus.19993DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8715838PMC
November 2021

Bilateral Spontaneous Pneumothorax in a COVID-19 and HIV-Positive Patient: A Case Report.

Front Med (Lausanne) 2021 16;8:698268. Epub 2021 Dec 16.

Department of Internal Medicine, Northeast Georgia Medical Center, Gainesville, GA, United States.

This case report describes a 60 year-old Black-American male with a past medical history of human immunodeficiency virus (HIV) infection and hyperthyroidism, who suffered a bilateral spontaneous pneumothorax (SP) in the setting of coronavirus disease 2019 (COVID-19) pneumonia. SP is a well-established complication in HIV-positive patients and only recently has been associated with severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) infection. While HIV and COVID-19 infections have been independently linked with increased risk of SP development, it is unknown if both infections interact in a synergistic fashion to exacerbate SP risk. According to the Centers for Disease Control and Prevention (CDC), patients living with HIV have a higher risk of developing severe COVID-19 infection and the mechanism remains to be elucidated. To the best of our knowledge, this is the first report of a HIV-positive patient, who in the setting of SARS-CoV-2 infection, developed bilateral apical spontaneous pneumothorax and was later found to have a left lower lobe tension pneumothorax. This case highlights the importance of considering SP on the differential diagnosis when HIV-positive patients suddenly develop respiratory distress in the setting of SARS-CoV-2 infection.
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http://dx.doi.org/10.3389/fmed.2021.698268DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8716636PMC
December 2021

Anticoagulant therapy for COVID-19: What we have learned and what are the unanswered questions?

Eur J Intern Med 2022 02 11;96:13-16. Epub 2021 Nov 11.

Institute of Health System Science, The Feinstein Institutes for Medical Research, Northwell Health, Manhasset, NY, USA; Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, Hempstead, New York, USA; Department of Obstetrics and Gynecology, I.M. Sechenov First Moscow State Medical University, Moscow, Russia. Electronic address:

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http://dx.doi.org/10.1016/j.ejim.2021.11.003DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8580837PMC
February 2022

Efficacy and Safety of Therapeutic-Dose Heparin vs Standard Prophylactic or Intermediate-Dose Heparins for Thromboprophylaxis in High-risk Hospitalized Patients With COVID-19: The HEP-COVID Randomized Clinical Trial.

JAMA Intern Med 2021 12;181(12):1612-1620

Department of Medicine, McMaster University, Hamilton, Ontario, Canada.

Importance: Hospitalized patients with COVID-19 are at risk for venous and arterial thromboembolism and death. Optimal thromboprophylaxis dosing in high-risk patients is unknown.

Objective: To evaluate the effects of therapeutic-dose low-molecular-weight heparin (LMWH) vs institutional standard prophylactic or intermediate-dose heparins for thromboprophylaxis in high-risk hospitalized patients with COVID-19.

Design, Setting, And Participants: The HEP-COVID multicenter randomized clinical trial recruited hospitalized adult patients with COVID-19 with D-dimer levels more than 4 times the upper limit of normal or sepsis-induced coagulopathy score of 4 or greater from May 8, 2020, through May 14, 2021, at 12 academic centers in the US.

Interventions: Patients were randomized to institutional standard prophylactic or intermediate-dose LMWH or unfractionated heparin vs therapeutic-dose enoxaparin, 1 mg/kg subcutaneous, twice daily if creatinine clearance was 30 mL/min/1.73 m2 or greater (0.5 mg/kg twice daily if creatinine clearance was 15-29 mL/min/1.73 m2) throughout hospitalization. Patients were stratified at the time of randomization based on intensive care unit (ICU) or non-ICU status.

Main Outcomes And Measures: The primary efficacy outcome was venous thromboembolism (VTE), arterial thromboembolism (ATE), or death from any cause, and the principal safety outcome was major bleeding at 30 ± 2 days. Data were collected and adjudicated locally by blinded investigators via imaging, laboratory, and health record data.

Results: Of 257 patients randomized, 253 were included in the analysis (mean [SD] age, 66.7 [14.0] years; men, 136 [53.8%]; women, 117 [46.2%]); 249 patients (98.4%) met inclusion criteria based on D-dimer elevation and 83 patients (32.8%) were stratified as ICU-level care. There were 124 patients (49%) in the standard-dose vs 129 patients (51%) in the therapeutic-dose group. The primary efficacy outcome was met in 52 of 124 patients (41.9%) (28.2% VTE, 3.2% ATE, 25.0% death) with standard-dose heparins vs 37 of 129 patients (28.7%) (11.7% VTE, 3.2% ATE, 19.4% death) with therapeutic-dose LMWH (relative risk [RR], 0.68; 95% CI, 0.49-0.96; P = .03), including a reduction in thromboembolism (29.0% vs 10.9%; RR, 0.37; 95% CI, 0.21-0.66; P < .001). The incidence of major bleeding was 1.6% with standard-dose vs 4.7% with therapeutic-dose heparins (RR, 2.88; 95% CI, 0.59-14.02; P = .17). The primary efficacy outcome was reduced in non-ICU patients (36.1% vs 16.7%; RR, 0.46; 95% CI, 0.27-0.81; P = .004) but not ICU patients (55.3% vs 51.1%; RR, 0.92; 95% CI, 0.62-1.39; P = .71).

Conclusions And Relevance: In this randomized clinical trial, therapeutic-dose LMWH reduced major thromboembolism and death compared with institutional standard heparin thromboprophylaxis among inpatients with COVID-19 with very elevated D-dimer levels. The treatment effect was not seen in ICU patients.

Trial Registration: ClinicalTrials.gov Identifier: NCT04401293.
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http://dx.doi.org/10.1001/jamainternmed.2021.6203DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8498934PMC
December 2021

The Fanconi anemia pathway and Breast Cancer: A comprehensive review of clinical data.

Clin Breast Cancer 2022 01 10;22(1):10-25. Epub 2021 Aug 10.

Feinstein Institutes for Medical Research at Northwell Health, Manhasset, New York, NY. Electronic address:

The development of breast cancer depends on several risk factors, including environmental, lifestyle and genetic factors. Despite the evolution of DNA sequencing techniques and biomarker detection, the epidemiology and mechanisms of various breast cancer susceptibility genes have not been elucidated yet. Dysregulation of the DNA damage response causes genomic instability and increases the rate of mutagenesis and the risk of carcinogenesis. The Fanconi Anemia (FA) pathway is an important component of the DNA damage response and plays a critical role in the repair of DNA interstrand crosslinks and genomic stability. The FA pathway involves 22 recognized genes and specific mutations have been identified as the underlying defect in the majority of FA patients. A thorough understanding of the function and epidemiology of these genes in breast cancer is critical for the development and implementation of individualized therapies that target unique tumor profiles. Targeted therapies (PARP inhibitors) exploiting the FA pathway gene defects have been developed and have shown promising results. This narrative review summarizes the current literature on the involvement of FA genes in sporadic and familial breast cancer with a focus on clinical data derived from large cohorts.
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http://dx.doi.org/10.1016/j.clbc.2021.08.001DOI Listing
January 2022

Vascular thromboembolic events following COVID-19 hospital discharge: Incidence and risk factors.

Res Pract Thromb Haemost 2021 Jul 27;5(5):e12547. Epub 2021 Jun 27.

Feinstein Institutes for Medical Research Northwell Health Manhasset NY USA.

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http://dx.doi.org/10.1002/rth2.12547DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8268660PMC
July 2021

Imaging in the COVID-19 era: Lessons learned during a pandemic.

World J Radiol 2021 Jun;13(6):192-222

Department of Radiology, University of Massachusetts Medical School, Baystate Medical Center, Springfield, MA 01199, United States.

The first year of the coronavirus disease 2019 (COVID-19) pandemic has been a year of unprecedented changes, scientific breakthroughs, and controversies. The radiology community has not been spared from the challenges imposed on global healthcare systems. Radiology has played a crucial part in tackling this pandemic, either by demonstrating the manifestations of the virus and guiding patient management, or by safely handling the patients and mitigating transmission within the hospital. Major modifications involving all aspects of daily radiology practice have occurred as a result of the pandemic, including workflow alterations, volume reductions, and strict infection control strategies. Despite the ongoing challenges, considerable knowledge has been gained that will guide future innovations. The aim of this review is to provide the latest evidence on the role of imaging in the diagnosis of the multifaceted manifestations of COVID-19, and to discuss the implications of the pandemic on radiology departments globally, including infection control strategies and delays in cancer screening. Lastly, the promising contribution of artificial intelligence in the COVID-19 pandemic is explored.
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http://dx.doi.org/10.4329/wjr.v13.i6.192DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8245753PMC
June 2021

External validation of the IMPROVE-DD risk assessment model for venous thromboembolism among inpatients with COVID-19.

J Thromb Thrombolysis 2021 Nov 19;52(4):1032-1035. Epub 2021 Jun 19.

Donald & Barbara Zucker School of Medicine at Hofstra/Northwell, Hempstead, USA.

There is a need to discriminate which COVID-19 inpatients are at higher risk for venous thromboembolism (VTE) to inform prophylaxis strategies. The IMPROVE-DD VTE risk assessment model (RAM) has previously demonstrated good discrimination in non-COVID populations. We aimed to externally validate the IMPROVE-DD VTE RAM in medical patients hospitalized with COVID-19. This retrospective cohort study evaluated the IMPROVE-DD VTE RAM in adult patients with COVID-19 admitted to one of thirteen Northwell Health hospitals in the New York metropolitan area between March 1, 2020 and April 27, 2020. VTE was defined as new-onset symptomatic deep venous thrombosis or pulmonary embolism. To assess the predictive value of the RAM, the receiver operating characteristic (ROC) curve was plotted and the area under the curve (AUC) was calculated. Sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) were calculated. Of 9407 patients who met study criteria, 274 patients developed VTE with a prevalence of 2.91%. The VTE rate was 0.41% for IMPROVE-DD score 0-1 (low risk), 1.21% for score 2-3 (moderate risk), and 5.30% for score ≥ 4 (high risk). Approximately 45.7% of patients were classified as high VTE risk, 33.3% moderate risk, and 21.0% low risk. Discrimination of low versus moderate-high VTE risk demonstrated sensitivity 0.971, specificity 0.215, PPV 0.036, and NPV 0.996. ROC AUC was 0.703. In this external validation study, the IMPROVE-DD VTE RAM demonstrated very good discrimination to identify hospitalized COVID-19 patients at low, moderate, and high VTE risk.
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http://dx.doi.org/10.1007/s11239-021-02504-5DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8214061PMC
November 2021

Magnetically Controlled Capsule Endoscopy Versus Conventional Gastroscopy: A Systematic Review and Meta-Analysis.

J Clin Gastroenterol 2021 08;55(7):577-585

Institute of Health Innovations and Outcomes Research, The Feinstein Institute for Medical Research, Manhasset, NY, 11030.

Background: The introduction of magnetically controlled capsule endoscopy overcame the restriction of passive capsule endoscopy movement, thus allowing an improved visualization of the gastrointestinal lumen, where other imaging studies seem to be unhelpful. The aim of this study is to systematically review the performance of magnetically controlled capsule endoscopy and evaluate its potential as a less invasive diagnostic method in the detection of gastric lesions.

Methods: A systematic search was performed in PubMed (Medline), EMBASE, Google Scholar, Scopus, Who Global Health Library (GHL), Virtual Health Library (VHL), Clinicaltrials.gov, Cochrane Library, and ISI Web of Science databases. Proportion meta-analyses were performed to estimate the pooled sensitivity of magnetically controlled capsuled endoscopy in the detection of gastrointestinal lesions.

Results: Among the 3026 studies that were initially assessed, 7 studies were finally included, with a total of 916 patients and 745 gastric lesions. The mean capsule endoscopy examination time was 21.92±8.87 minutes. The pooled overall sensitivity of magnetically controlled capsule endoscopy was 87% [95% confidence interval (CI), 84%-89%]. Subgroup analysis showed that the sensitivity of identifying gastric ulcers was 82% (95% CI: 71%-89%), gastric polyps was 82% (95% CI: 76%-87%), and gastric erosions was 95% (95% CI: 86%-98%). In general, magnetically controlled capsule endoscopy was well tolerated by the participants with minimal adverse events.

Conclusion: The magnetically controlled capsule endoscopy demonstrated an acceptable sensitivity of identifying gastric lesions. Further prospective comparative studies are needed to identify the risks and benefits of this new technique, as well as to determine its role as a replacement for conventional gastroscopy.
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http://dx.doi.org/10.1097/MCG.0000000000001540DOI Listing
August 2021

Laparoscopic versus open hepatectomy for intrahepatic cholangiocarcinoma: An individual patient data survival meta-analysis.

Am J Surg 2021 Oct 26;222(4):731-738. Epub 2021 Mar 26.

Department of Surgery, Division of Hepatobiliary Surgery and Liver Transplantation, Vanderbilt University Medical Center, Nashville, TN, USA. Electronic address:

Background: We compared the outcomes of laparoscopic hepatectomy (LH) vs. open hepatectomy (OH) for intrahepatic cholangiocarcinoma (iCCA).

Methods: A systematic review of the MEDLINE, EMBASE, Scopus, and Cochrane Library databases was performed using PRISMA guidelines (end-of-search date: 08-June-2020). Individual patient data on overall survival (OS) and recurrence-free survival (RFS) were extracted. Random-effects meta-analyses, and one- and two-stage survival analyses were conducted.

Results: Eight retrospective cohort studies comparing LH (n = 544) vs. OH (n = 2256) were identified. LH demonstrated lower overall complication (Risk ratio [RR] = 0.64, 95% confidence interval [CI]: 0.46-0.90; p = 0.01), surgical lymphadenectomy (RR = 0.74, 95% CI: 0.58-0.93; p = 0.01) and margin-positive resection (RR = 0.78, 95% CI: 0.62-0.99; p = 0.04) rates, and higher recurrence-free rate (RR = 1.24, 95% CI: 1.01-1.51; p = 0.04) vs. OH. In Cox regression, no difference was observed regarding OS (Hazard Ratio [HR] = 1.11, 95% CI: 0.65-1.91; p = 0.70) and RFS (HR = 1.19, 95% CI: 0.74-1.90; p = 0.47).

Conclusion: The use of LH should be considered when feasible in well-selected iCCA patients by hepatobiliary surgeons with experience in minimally-invasive surgery.
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http://dx.doi.org/10.1016/j.amjsurg.2021.03.052DOI Listing
October 2021

Postdischarge thromboembolic outcomes and mortality of hospitalized patients with COVID-19: the CORE-19 registry.

Blood 2021 05;137(20):2838-2847

Institute of Health Innovations and Outcomes Research, Feinstein Institutes for Medical Research, Northwell Health, Manhasset, NY.

Thromboembolic events, including venous thromboembolism (VTE) and arterial thromboembolism (ATE), and mortality from subclinical thrombotic events occur frequently in coronavirus disease 2019 (COVID-19) inpatients. Whether the risk extends postdischarge has been controversial. Our prospective registry included consecutive patients with COVID-19 hospitalized within our multihospital system from 1 March to 31 May 2020. We captured demographics, comorbidities, laboratory parameters, medications, postdischarge thromboprophylaxis, and 90-day outcomes. Data from electronic health records, health informatics exchange, radiology database, and telephonic follow-up were merged. Primary outcome was a composite of adjudicated VTE, ATE, and all-cause mortality (ACM). Principal safety outcome was major bleeding (MB). Among 4906 patients (53.7% male), mean age was 61.7 years. Comorbidities included hypertension (38.6%), diabetes (25.1%), obesity (18.9%), and cancer history (13.1%). Postdischarge thromboprophylaxis was prescribed in 13.2%. VTE rate was 1.55%; ATE, 1.71%; ΑCM, 4.83%; and MB, 1.73%. Composite primary outcome rate was 7.13% and significantly associated with advanced age (odds ratio [OR], 3.66; 95% CI, 2.84-4.71), prior VTE (OR, 2.99; 95% CI, 2.00-4.47), intensive care unit (ICU) stay (OR, 2.22; 95% CI, 1.78-2.93), chronic kidney disease (CKD; OR, 2.10; 95% CI, 1.47-3.0), peripheral arterial disease (OR, 2.04; 95% CI, 1.10-3.80), carotid occlusive disease (OR, 2.02; 95% CI, 1.30-3.14), IMPROVE-DD VTE score ≥4 (OR, 1.51; 95% CI, 1.06-2.14), and coronary artery disease (OR, 1.50; 95% CI, 1.04-2.17). Postdischarge anticoagulation was significantly associated with reduction in primary outcome (OR, 0.54; 95% CI, 0.47-0.81). Postdischarge VTE, ATE, and ACM occurred frequently after COVID-19 hospitalization. Advanced age, cardiovascular risk factors, CKD, IMPROVE-DD VTE score ≥4, and ICU stay increased risk. Postdischarge anticoagulation reduced risk by 46%.
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http://dx.doi.org/10.1182/blood.2020010529DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8032474PMC
May 2021

Treatment-Dose LMWH versus Prophylactic/Intermediate Dose Heparins in High-Risk COVID-19 Inpatients: Rationale and Design of the HEP-COVID Trial.

Thromb Haemost 2021 12 28;121(12):1684-1695. Epub 2021 May 28.

Institute of Health Innovations and Outcomes Research, The Feinstein Institutes for Medical Research, Northwell Health, Manhasset, New York, United States.

Coronavirus disease-2019 (COVID-19) has been associated with significant risk of venous thromboembolism (VTE), arterial thromboembolism (ATE), and mortality particularly among hospitalized patients with critical illness and elevated D-dimer (Dd) levels. Conflicting data have yet to elucidate optimal thromboprophylaxis dosing. HEP-COVID (NCT04401293) is a phase 3, multicenter, pragmatic, prospective, randomized, pseudo-blinded, active control trial to evaluate efficacy and safety of therapeutic-dose low-molecular-weight heparin (LMWH) versus prophylactic-/intermediate-dose LMWH or unfractionated heparin (UFH) for prevention of a primary efficacy composite outcome of VTE, ATE, and all-cause mortality 30 ± 2 days post-enrollment. Eligible patients have COVID-19 diagnosis by nasal swab or serologic testing, requirement for supplemental oxygen per investigator judgment, and Dd >4 × upper limit of normal (ULN) or sepsis-induced coagulopathy score ≥4. Subjects are randomized to enoxaparin 1 mg/kg subcutaneous (SQ)/two times a day (BID) (creatinine clearance [CrCl] ≥ 30 mL/min) or 0.5 mg/kg (CrCl 15-30 mL/min) versus local institutional prophylactic regimens including (1) UFH up to 22,500 IU (international unit) daily (divided BID or three times a day), (2) enoxaparin 30 and 40 mg SQ QD (once daily) or BID, or (3) dalteparin 2,500 IU or 5,000 IU QD. The principal safety outcome is major bleeding. Events are adjudicated locally. Based on expected 40% relative risk reduction with treatment-dose compared with prophylactic-dose prophylaxis, 308 subjects will be enrolled (assuming 20% drop-out) to achieve 80% power. Distinguishing design features include an enriched population for the composite endpoint anchored on Dd >4 × ULN, stratification by intensive care unit (ICU) versus non-ICU, and the ability to capture asymptomatic proximal deep venous thrombosis via screening ultrasonography prior to discharge.
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http://dx.doi.org/10.1055/a-1475-2351DOI Listing
December 2021

Diagnostic, Predictive and Prognostic Molecular Biomarkers in Pancreatic Cancer: An Overview for Clinicians.

Cancers (Basel) 2021 Mar 3;13(5). Epub 2021 Mar 3.

Department of Surgery, Duke University Medical Center, Durham, NC 27710, USA.

Pancreatic ductal adenocarcinoma (PDAC) is the most common pancreatic malignancy and is associated with aggressive tumor behavior and poor prognosis. Most patients with PDAC present with an advanced disease stage and treatment-resistant tumors. The lack of noninvasive tests for PDAC diagnosis and survival prediction mandates the identification of novel biomarkers. The early identification of high-risk patients and patients with PDAC is of utmost importance. In addition, the identification of molecules that are associated with tumor biology, aggressiveness, and metastatic potential is crucial to predict survival and to provide patients with personalized treatment regimens. In this review, we summarize the current literature and focus on newer biomarkers, which are continuously added to the armamentarium of PDAC screening, predictive tools, and prognostic tools.
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http://dx.doi.org/10.3390/cancers13051071DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7959127PMC
March 2021

Validation of the IMPROVE-DD risk assessment model for venous thromboembolism among hospitalized patients with COVID-19.

Res Pract Thromb Haemost 2021 Feb 24;5(2):296-300. Epub 2021 Feb 24.

North Shore University Hospital Northwell Health Manhasset NY USA.

Background: Antithrombotic guidance statements for hospitalized patients with coronavirus disease 2019 (COVID-19) suggest a universal thromboprophylactic strategy with potential to escalate doses in high-risk patients. To date, no clear approach exists to discriminate patients at high risk for venous thromboembolism (VTE).

Objectives: The objective of this study is to externally validate the IMPROVE-DD risk assessment model (RAM) for VTE in a large cohort of hospitalized patients with COVID-19 within a multihospital health system.

Methods: This retrospective cohort study evaluated the IMPROVE-DD RAM on adult inpatients with COVID-19 hospitalized between March 1, 2020, and April 27, 2020. Diagnosis of VTE was defined by new acute deep venous thrombosis or pulmonary embolism by Radiology Department imaging or point-of-care ultrasound. The receiver operating characteristic (ROC) curve was plotted and area under the curve (AUC) calculated. Sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) were calculated using standard methods.

Results: A total of 9407 patients were included, with a VTE prevalence of 2.9%. The VTE rate was 0.4% for IMPROVE-DD score 0-1 (low risk), 1.3% for score 2-3 (moderate risk), and 5.3% for score ≥ 4 (high risk). Approximately 45% of the total population scored high VTE risk, while 21% scored low VTE risk. IMPROVE-DD discrimination of low versus medium/high risk showed sensitivity of 0.971, specificity of 0.218, PPV of 0.036, and NPV of 0.996. ROC AUC was 0.702.

Conclusions: The IMPROVE-DD VTE RAM demonstrated very good discrimination to identify hospitalized patients with COVID-19 as low, moderate, and high VTE risk in this large external validation study with potential to individualize thromboprophylactic strategies.
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http://dx.doi.org/10.1002/rth2.12486DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7938615PMC
February 2021

Incidence of Venous Thromboembolism and Mortality in Patients with Initial Presentation of COVID-19.

J Thromb Thrombolysis 2021 May 5;51(4):897-901. Epub 2021 Mar 5.

Feinstein Institutes for Medical Research, Northwell Health, Manhasset, NY, USA.

Venous thromboembolism (VTE) has emerged as an important issue in patients with COVID-19. The purpose of this study is to identify the incidence of VTE and mortality in COVID-19 patients initially presenting to a large health system. Our retrospective study included adult patients (excluding patients presenting with obstetric/gynecologic conditions) across a multihospital health system in the New York Metropolitan Region from March 1-April 27, 2020. VTE and mortality rates within 8 h of assessment were described. In 10,871 adults with COVID-19, 118 patients (1.09%) were diagnosed with symptomatic VTE (101 pulmonary embolism, 17 deep vein thrombosis events) and 28 patients (0.26%) died during initial assessment. Among these 146 patients, 64.4% were males, 56.8% were 60 years or older, 15.1% had a BMI > 35, and 11.6% were admitted to the intensive care unit. Comorbidities included hypertension (46.6%), diabetes (24.7%), hyperlipidemia (14.4%), chronic lung disease (12.3%), coronary artery disease (11.0%), and prior VTE (7.5%). Key medications included corticosteroids (22.6%), statins (21.2%), antiplatelets (20.6%), and anticoagulants (20.6%). Highest D-Dimer was greater than six times the upper limit of normal in 51.4%. Statin and antiplatelet use were associated with decreased VTE or mortality (each p < 0.01). In COVID-19 patients who initially presented to a large multihospital health system, the overall symptomatic VTE and mortality rate was over 1.0%. Statin and antiplatelet use were associated with decreased VTE or mortality. The potential benefits of antithrombotics in high risk COVID-19 patients during the pre-hospitalization period deserves study.
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http://dx.doi.org/10.1007/s11239-021-02413-7DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7932762PMC
May 2021

Challenges of Hematopoietic Stem Cell Transplantation in the Era of COVID-19.

Exp Clin Transplant 2022 03 24;20(3):237-245. Epub 2021 Feb 24.

From the Surgery Working Group, Society of Junior Doctors, Athens, Greece.

The coronavirus disease 2019 (COVID-19) pandemic raised unprecedented concerns in the hematopoietic stem cell transplant community. The diagnosis of COVID-19 in these transplant recipients may require extensive laboratory testing and high clinical suspicion, as atypical clinical manifestations or other respiratory viral infections are common in this patient population. The underlying malignancies, immunosuppressed state, frequently observed coinfections, and advanced age in some patients may also predispose them to worse clinical outcomes. Similar outcomes have been previously described with other human coronaviruses, including the severe acute respiratory syndrome coronavirus and the Middle East respiratory syndrome coronavirus. Many hematopoietic stem cell transplant organizations have issued elaborative guidelines that aim to prevent transmission and hence adverse patient outcomes. All potential donors are thoroughly screened, and donated products are cryopreserved in advance. Potential hematopoietic stem cell transplant recipients are also screened, and most nonurgent transplant cases with low risk of progression and/or death are deferred. Current hematopoietic stem cell transplant recipients should adhere to precaution and isolation measures, while their transplant units should also follow strict safety protocols, similar to other infectious outbreaks. The prolonged susceptibility of hematopoietic stem cell transplant recipients to respiratory viral infections might necessitate extending these measures even after the peak of the outbreak until a gradually return to normality is possible.
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http://dx.doi.org/10.6002/ect.2020.0326DOI Listing
March 2022

Heart and Lung Transplantation in the Era of COVID-19: Early Recommendations and Outcomes.

Exp Clin Transplant 2021 11 1;19(11):1117-1123. Epub 2021 Feb 1.

From the Thoracic Surgery Department, University College London Hospitals, NHS Foundation Trust, London, United Kingdom.

The severe acute respiratory syndrome coronavirus 2 pandemic has dramatically changed medical practices worldwide. These changes have been aimed both to reallocate resources toward fighting the novel coronavirus and to prevent its transmission during nonurgent medical and surgical interventions. Heart and lung transplantation could not be an exception, as most transplant centers have either restricted their activity to only urgent, lifesaving procedures or stopped these surgical procedures for various periods of time depending on the local virus epidemiology. The effect of this infection on the immunosuppressed heart and lung transplant recipient is still questionable; however, there are limited reports suggesting that there is no increased risk of transmission or more severe disease course compared with that shown in the general population. Transplant organizations have disseminated early recommendations as a guidance in a yet evolving situation. Finally, data suggest that lung transplant could potentially serve as an ultimate, lifesaving procedure for COVID-19-related end-stage respiratory failure in carefully selected patients.
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http://dx.doi.org/10.6002/ect.2020.0289DOI Listing
November 2021

Validation of the 8th Edition American Joint Commission on Cancer (AJCC) Gallbladder Cancer Staging System: Prognostic Discrimination and Identification of Key Predictive Factors.

Cancers (Basel) 2021 Feb 1;13(3). Epub 2021 Feb 1.

Department of Surgery, Duke University Medical Center, Durham, NC 27710, USA.

The scope of our study was to compare the predictive ability of American Joint Committee on Cancer (AJCC) 7th and 8th edition in gallbladder carcinoma (GBC) patients, investigate the effect of AJCC 8th nodal status on the survival, and identify risk factors associated with the survival after N reclassification using the National Cancer Database (NCDB) in the period 2005-2015. The cohort consisted of 7743 patients diagnosed with GBC; 202 patients met the criteria for reclassification and were denoted as stage ≥III by AJCC 7th and 8th edition criteria. Overall survival concordance indices were similar for patients when classified by AJCC 8th (OS c-index: 0.665) versus AJCC 7th edition (OS c-index: 0.663). Relative mortality was higher within strata of T1, T2, and T3 patients with N2 compared with N1 stage (T1 HR: 2.258, < 0.001; T2 HR: 1.607, < 0.001; Τ3 HR: 1.306, < 0.001). The risk of death was higher in T1-T3 patients with Nx compared with N1 stage (T1 HR: 1.281, = 0.043, T2 HR: 2.221, < 0.001, T3 HR: 2.194, < 0.001). In patients with AJCC 8th edition stage ≥IIIB GBC and an available grade, univariate analysis showed that higher stage, Charlson-Deyo score ≥ 2, higher tumor grade, and unknown nodal status were associated with an increased risk of death, while year of diagnosis after 2013, academic center, chemotherapy. and radiation therapy were associated with decreased risk of death. Chemotherapy and radiation therapy were associated with decreased risk of death in patients with T3-T4 and T2-T4 GBC, respectively. In conclusion, the updated AJCC 8th GBC staging system was comparable to the 7th edition, with the recently implemented changes in N classification assessment failing to improve the prognostic performance of the staging system. Further prospective studies are needed to validate the T2 stage subclassification as well as to clarify the association, if any is actually present, between advanced N staging and increased risk of death in patients of the same T stage.
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http://dx.doi.org/10.3390/cancers13030547DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7867111PMC
February 2021

Prevalence and Predictors of Venous Thromboembolism or Mortality in Hospitalized COVID-19 Patients.

Thromb Haemost 2021 08 11;121(8):1043-1053. Epub 2022 Mar 11.

Feinstein Institutes for Medical Research, Northwell Health, Manhasset, New York, United States.

Background: We aimed to identify the prevalence and predictors of venous thromboembolism (VTE) or mortality in hospitalized coronavirus disease 2019 (COVID-19) patients.

Methods: A retrospective cohort study of hospitalized adult patients admitted to an integrated health care network in the New York metropolitan region between March 1, 2020 and April 27, 2020. The final analysis included 9,407 patients with an overall VTE rate of 2.9% (2.4% in the medical ward and 4.9% in the intensive care unit [ICU]) and a VTE or mortality rate of 26.1%. Most patients received prophylactic-dose thromboprophylaxis. Multivariable analysis showed significantly reduced VTE or mortality with Black race, history of hypertension, angiotensin converting enzyme/angiotensin receptor blocker use, and initial prophylactic anticoagulation. It also showed significantly increased VTE or mortality with age 60 years or greater, Charlson Comorbidity Index (CCI) of 3 or greater, patients on Medicare, history of heart failure, history of cerebrovascular disease, body mass index greater than 35, steroid use, antirheumatologic medication use, hydroxychloroquine use, maximum D-dimer four times or greater than the upper limit of normal (ULN), ICU level of care, increasing creatinine, and decreasing platelet counts.

Conclusion: In our large cohort of hospitalized COVID-19 patients, the overall in-hospital VTE rate was 2.9% (4.9% in the ICU) and a VTE or mortality rate of 26.1%. Key predictors of VTE or mortality included advanced age, increasing CCI, history of cardiovascular disease, ICU level of care, and elevated maximum D-dimer with a cutoff at least four times the ULN. Use of prophylactic-dose anticoagulation but not treatment-dose anticoagulation was associated with reduced VTE or mortality.
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http://dx.doi.org/10.1055/a-1366-9656DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC9044533PMC
August 2021

The Epidemiology, Staging and Outcomes of Sarcomatoid Hepatocellular Carcinoma: A SEER Population Analysis.

In Vivo 2021 Jan-Feb;35(1):393-399

Duke Surgery, Duke University Medical Center, Durham, NC, U.S.A.

Background: Hepatocellular carcinoma (HCC) subtypes differ in terms of histopathology and prognosis. Sarcomatoid HCC is rare and literature concerning the survival of patients with sarcomatoid HCC is scarce.

Materials And Methods: Data of patients with sarcomatoid HCC, diagnosed from 1989 to 2016, were extracted from the Surveillance, Epidemiology and End Results (SEER) database. We evaluated the baseline and tumor related data, overall survival (OS), disease-specific survival and the performance (Harrell's concordance index - OS c-index) of the eighth edition of the American Joint Committee on Cancer TNM staging system (AJCC8). In addition, univariate and multivariate forward stepwise cox regression analyses were performed to identify factors associated with increased risk of death.

Results: The SEER cohort consisted of 71 patients, mostly males (n=49, 69.0%), of White race (n=51, 71.8%) and the most common stage at presentation was stage IVB (n=30, 42.3%). The overall predictive ability of AJCC8 was mediocre, with an OS c-index=0.577 (SE=0.048). Surgery (hazard ratio=0.25, p<0.001) was significantly associated with reduced risk of death. Advanced TNM stage was not associated with increased risk of death.

Conclusion: Sarcomatoid HCC, a rare subtype of HCC, is associated with poor outcomes in terms of overall and disease-specific survival across all disease stages. Surgery seems to be of utmost importance. The eighth edition of the AJCC8 for HCC underperforms in predicting the survival of patients with sarcomatoid subtype.
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http://dx.doi.org/10.21873/invivo.12270DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7880738PMC
June 2021

The anti-adhesive effect of anti-VEGF agents in experimental models: A systematic review.

Wound Repair Regen 2021 01 14;29(1):168-182. Epub 2020 Dec 14.

Department of Vascular Surgery, The Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, Northwell Health, New Hyde Park, New York, USA.

Adhesions constitute a major problem in abdominal-pelvic and thoracic surgery with significant impact in the postoperative quality of life and healthcare services utilization. Adhesiogenesis is the result of increased fibrin formation, impaired fibrinolysis, angiogenesis, and fibrosis. Despite the recent advancements, the ideal anti-adhesive agent remains to be determined. To this end, we performed a comprehensive literature search in PubMed, EMBASE, and Scopus databases to identify studies investigating the antiadhesive role of anti-VEGF agents in peritoneal, pleural, and pericardial experimental adhesion models. Fifteen studies were eligible for inclusion with a total population of 602 animals (334 rats, 180 rabbits, and 88 mice). The majority of included studies (11/15) used bevacizumab, while three studies used other anti-VEGF antibodies and one study used an anti-VEGFR-antibody. A rat model was used in nine studies, while rabbit (n = 3) or mouse (n = 3) models were used less frequently. Eleven studies used peritoneal models, three studies used pleural models, and one study used a pericardial model. The scales (n = 12) and interval (Range: 1-42 days) used for the evaluation of adhesions varied between the studies. All studies demonstrated a significant decrease in adhesion scores between the anti-VEGF and control groups up to 42 days postprocedure. VEGF blockade resulted in decreased fibrosis in four out of five studies that used peritoneal models, while the effect on pleural models depended on the pleurodesis agent and was significant between 7 and 28 days. The effect of anti-VEGF agents on anastomosis integrity depends on the dose and the model that is used (inconclusive results).Current data support the anti-adhesive role of Anti-VEGF agents in all three serosal surfaces up to 6 weeks postprocedure. Further studies are needed to confirm the anti-adhesive role of anti-VEGF agents in pleural and pericardial adhesion experimental models and investigate any effect on anastomosis integrity in peritoneal models.
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http://dx.doi.org/10.1111/wrr.12879DOI Listing
January 2021

The Role of Immunotherapy in Hepatocellular Carcinoma: A Systematic Review and Pooled Analysis of 2,402 Patients.

Oncologist 2021 06 2;26(6):e1036-e1049. Epub 2021 Jan 2.

First Department of Surgery, Aristotle University of Thessaloniki, Thessaloniki, Greece.

Background: Immune checkpoints inhibitors (ICIs) have emerged as a treatment option for several malignancies. Nivolumab, pembrolizumab, nivolumab plus ipilimumab, and atezolizumab plus bevacizumab have been approved for the management of advanced-stage hepatocellular carcinoma (HCC). We aimed to systematically review the literature and summarize the characteristics and outcomes of patients with HCC treated with ICIs.

Methods: A systematic literature search of PubMed, the Cochrane Library, and ClinicalTrials.gov was performed according to the PRISMA statement (end of search date: November 7, 2020). Quality of evidence assessment was also performed.

Results: Sixty-three articles including 2,402 patients were analyzed, 2,376 of whom received ICIs for unresectable HCC. Response to ICIs could be evaluated in 2,116 patients; the overall objective response rate (ORR) and disease control rate (DCR) were 22.7% and 60.7%, respectively, and the mean overall survival (OS) was 15.8 months. The ORR, DCR, and OS for nivolumab (n = 846) were 19.7%, 51.1%, and 18.7 months, respectively; for pembrolizumab (n = 435) they were 20.7%, 64.6% and 13.3 months, respectively. The combination of atezolizumab/bevacizumab (n = 460) demonstrated an ORR and DCR of 30% and 77%, respectively. The overall rate of treatment discontinuation because of adverse events was 14.9%. Fifteen patients received ICIs in the liver transplant (LT) setting (one pre-LT for bridging, 14 for post-LT recurrence); fatal graft rejection was reported in 40.0% (n = 6/15) and mortality in 80.0% (n = 12/15).

Conclusion: ICIs are safe and effective against unresectable HCC, but caution is warranted regarding their use in the LT setting because of the high graft rejection rate.

Implications For Practice: This systematic review pooled the outcomes from studies reporting on the use of immune checkpoint inhibitors (ICIs) for the management of 2,402 patients with advanced-stage hepatocellular carcinoma (HCC), 2,376 of whom had unresectable HCC. The objective response rate and disease control rate were 22.7% and 60.7%, respectively, and the mean overall survival was 15.8 months. The overall rate of treatment discontinuation because of adverse events was 14.9%. Fifteen patients received ICIs in the liver transplant (LT) setting (one pre-LT for bridging, 14 for post-LT recurrence). Six of these patients experienced graft rejection (40.0%).
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http://dx.doi.org/10.1002/onco.13638DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8176986PMC
June 2021

Initial experience with neoadjuvant FOLFIRINOX as first line therapy for locally advanced pancreatic cancer.

J BUON 2020 Sep-Oct;25(5):2525-2527

Nicosia Department of Surgery/Div. HPB, 93 Agiou Nikolaou Street, Engomi, 2408, Nicosia, Cyprus.

The prevalence of pancreatic ductal adenocarcinoma (PDAC) is increasing in the western world, being currently on of the leading causes of mortality. Surgical resection provides best chances of cure but, unfortunately, less than 20% of the patients are eligible for curative intent surgery at the time of diagnosis. Chemotherapeutic agents such as FOLFIRINOX have been used in patients with metastatic or locally advanced disease showing survival benefit.

Methods: In this pilot study, we present an early initial experience with neoadjuvant FOLFIRINOX as first line therapy for locally advanced and non resectable PDAC highlighting the toxicity and complete resection rates as well as overall survival.

Results: Roughly every patient experienced toxicity according to ECOG criteria with a median recorded event up to 6, most of them grade I and grade II. One third of the patients had downsizing of tumor, however only 43.3% of them ended up having resectable disease. A R0 resection was achieved in 10 of the patients (76.9%). Median follow up for the entire study was 14 months. Fourteen patients (46.6%) had stable disease and 7 (23.3%) had tumor-related death. Approximately 30% of the patients were in remission by the end of follow up. Considering the above results patients that had good response to FOLFIRINOX and underwent R0 surgical treatment had increased their median survival to 30 months compared to those who did not have oncological tumor resection (13 months).

Conclusions: FOLFIRINOX is an effective treatment regimen that manages to convert unresectable -at diagnosis PDAC- to resectable with increased survival. However, due to high toxicity, treatment is only feasible in selected patients and requires close monitoring.
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August 2021

COVID-19 and Liver Transplantation: Early Reports and Recommendations.

Exp Clin Transplant 2020 Nov 27. Epub 2020 Nov 27.

From the Institute of Health Innovations and Outcomes Research, Feinstein Institute for Medical Research, Manhasset, New York, USA.

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http://dx.doi.org/10.6002/ect.2020.0229DOI Listing
November 2020
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