Discrepancies in Financial Conflicts of Interest in Robotic Cardiothoracic Surgery Studies.

BACKGROUND: In academic surgery publications, self-reporting of conflicts of interest (COI) has often proved to be inaccurate. Here, we review the accuracy of COI disclosures for studies related to the use of robotic technology in cardiothoracic surgery and evaluate factors associated with increased discrepancies. METHODS: A literature search identified robotic surgery-related studies with at least 1 American author published between January 2015 and December 2020 from 3 major American cardiothoracic surgery journals (The Journal of Thoracic and Cardiovascular Surgery, The Annals of Thoracic Surgery, and Annals of Cardiothoracic Surgery). Industry payments from Intuitive Surgical (Intuitive) were collected with use of the Centers for Medicare and Medicaid Open Payments database. COI discrepancies were identified by comparing author declaration statements with payments found for the year of publication and the year prior (24-month period). RESULTS: A total of 144 studies (764 authors) were identified. At least 1 author of 112 studies (78%) had received payments from Intuitive. At least 1 author of 98 studies (68%) had received an undeclared payment from Intuitive. Authors who accurately disclosed payments received significantly higher median payments compared with authors who did not ($16,511 [interquartile range, $6389-$159,035] vs $1762 [interquartile range, $338-$7500]; P < .0001). Last authors were significantly more likely to have a COI discrepancy compared with middle and first authors (P = .018; P = .0015). CONCLUSIONS: Most studies investigating the use of robotic technology in cardiothoracic surgery did not accurately declare COI with Intuitive. This study highlights the need for improved accuracy of reporting industry sponsorship by publishing authors.

Assessment of Conflicts of Interest in the Transcarotid Artery Revascularization Literature.

INTRODUCTION: To systematically review the accuracy of self-reported conflicts of interest (COIs) among transcarotid artery revascularization (TCAR) studies and evaluate factors associated with increased discrepancies. MATERIALS AND METHODS: A literature search identified all TCAR-related studies with at least one American author published between January 2017 and December 2020. Industry payments from Silk Road Medical, Inc. were collected using the Centers for Medicare and Medicaid Open Payments database. COI discrepancies were identified by comparing author declaration statements with payments found for the year of publication and year prior (24-mo period). Risk factors for COI discrepancy were evaluated at both the study and author level. RESULTS: A total of 79 studies (472 authors) were identified. Sixty four studies (81%) had at least one author who received payments from Silk Road Medical, Inc. Fifty eight (73%) studies had at least one author who received an undeclared payment. Consulting fees represented the majority of general payment subtype (60%). Authors who accurately disclosed payments received significantly higher median payments compared to authors who did not accurately disclose payments ($37,222 [interquartile range: $28,203-$132,589] versus $1748 [interquartile range $257-$35,041], P < 0.0001). Senior authors were significantly more likely to have a COI discrepancy compared to first authors (P = 0.0219). CONCLUSIONS: The majority of TCAR-related studies did not accurately declare COI. A multivariate analysis demonstrated no effect of sponsorship on study recommendations or impact factor. This study highlights the need for increased efforts in accountability to improve the transparency of industry sponsorship, especially when consulting authors are reporting their results on patient outcomes.

Readmissions after emergent incisional ventral hernia repair: a retrospective review of the nationwide readmissions database.

Emergent ventral hernia repair (eVHR) is associated with significant morbidity, yet there is no consensus regarding optimal surgical approach. We hypothesized that eVHR with synthetic mesh would have a higher readmission rate compared to primary eVHR or biologic mesh repair. Retrospective analysis of the Nationwide Readmissions Database (NRD) was conducted for patient entries between 2016 and 2018. Adult patients who underwent eVHR were included. Patient demographics, comorbidities, and surgical techniques were compared between readmitted and non-readmitted patients. Predictors of readmission were assessed using multivariate analysis with propensity weighting for various eVHR techniques. Secondary outcomes included hospital length of stay and readmission diagnoses. 43,819 patients underwent eVHR; of the 22,732 with 6 months of follow-up, 6382 (28.1%) were readmitted. The majority of readmissions occurred within the first 30 days (51.8%). Over half of the readmissions were related to surgical complications (50.6%), the most common being superficial surgical site infection (30.1%) and bowel obstruction/ileus (12.2%). In the multivariate analysis, predictors of 30-day readmission included use of synthetic mesh (OR 1.07, 95% CI 1.00-1.14), biologic mesh (OR 1.26, 95% CI 1.06-1.49), and need for concomitant large bowel resection (OR 1.46, 95% CI 1.30-1.65). eVHR is associated with high rates of readmission. Primary repair had favorable odds for readmission and lower risk of surgical complications compared to synthetic and biologic mesh repairs. Synthetic repair had lower odds of readmission than biologic repair. Given the inherent limitations of the NRD, further institutional prospective studies are required to confirm these findings.

Long-Term Outcomes of Persistent Post-Operative Opioid Use: A Retrospective Cohort Study.

OBJECTIVE: To determine the association between persistent post-operative opioid use and the long-term risk of opioid use disorder and opioid overdose. SUMMARY BACKGROUND DATA: Persistent post-operative opioid use is a commonly used outcome in the surgical literature; its incidence and risk factors have been well described. However, its association to long term outcomes, including opioid use disorder and opioid overdose, is unknown. METHODS: A retrospective cohort study utilizing the Veterans Health Administration corporate data warehouse. Patients undergoing any surgery between January 1st 2008 and December 31st 2018 were included and followed until December 31st 2020. Univariate and multivariate survival analysis were used to determine the association between persistent post-operative opioid use and opioid use disorder and overdose. Sensitivity analyses were conducted to determine the impact of different definitions of persistent opioid use and the effect of pre-operative opioid use. RESULTS: 304,780 patients undergoing surgery were included and followed for a median of 5.56 years (IQR 3.08-8.65). Persistent post-operative opioid use was associated with an increased hazard of developing both opioid use disorder (HR = 1.88, CI: 1.80-1.96, p < 0.001) and overdose (HR = 1.78, CI: 1.67-1.90, p < 0.001). This association remained consistent after adjustment for comorbidities and across all sensitivity analyses. CONCLUSIONS: Surgical patients who develop persistent post-operative opioid use are at increased risk of both opioid use disorder and overdose as compared to surgical patients who do not develop persistent use.

Assessment of Financial Conflicts of Interest Related to the Use of Dermal Substitutes in Burn Management.

This study aims to systematically review the accuracy of the self-reporting of conflicts of interest (COIs) among studies related to the use of dermal substitute products in burn management and evaluate factors associated with increased discrepancies. To do so, a literature search was done to identify studies investigating the use of dermal substitutes in burn management published between 2015 and 2019. Industry payments were collected using the Centers for Medicare and Medicaid Services Open Payments database. Declared COIs were then compared with the listed payments. Studies and authors were considered to have a COI if they received payments totaling more than $100 for each company. A total of 51 studies (322 authors) were included for analysis. Forty studies and 104 authors received at least one payment from the industry. Of these studies, 38 (95%) studies and 91 (88%) authors were found to have a COI discrepancy. From 2015 to 2019, 1391 general payments (totaling $1,696,848) and 108 research payments (totaling $1,849,537) were made by 82 companies. When increasing the threshold on what would be considered an undisclosed payment, the proportion of authors with discrepancies gradually decreased, from 88% of authors with undisclosed payments more than $100 to 27% of authors with undisclosed payments more than $10,000. Author order, journal impact factor, and study type were not significantly associated with increased risk of discrepancy. We found that the majority of studies investigating the use of dermal substitute products for burn management did not accurately declare COI, highlighting the need for a uniform declaration process and greater transparency of industry sponsorship by authors when publishing peer-reviewed burn surgery research papers.

Conflicts of Interest in Studies Related to Mesh Use in Ventral Hernia Repair and Abdominal Wall Reconstruction.

OBJECTIVE: To examine the accuracy of the reporting of conflicts of interest (COI) among studies related to mesh use in ventral hernia repair and abdominal wall reconstruction. SUMMARY BACKGROUND DATA: Accurate declaration of COI is integral to ensuring transparency of study results. Multiple studies have demonstrated undeclared COI are prevalent in surgical literature. METHODS: Studies with at least 1 American author accepted between 2014 and 2018 in 12 major, peer-reviewed general surgery and plastic surgery journals were included. Declared COI were compared with payments listed in the "Open Payments" database [maintained by the Centers for Medicare & Medicaid Services (CMS)] during the year of acceptance and 1 year prior. Studies and authors were considered to have a COI if they received payments from any of 8 major mesh companies totaling >$100.00 from each company. Risk factors for undeclared COI were determined at the study and author levels. RESULTS: One hundred twenty-six studies (553 authors) were included. One hundred two studies (81.0%) had one or more authors who received payments from industry and inaccurately declared their COI. Two hundred forty-eight authors (44.8%) did not declare their COI accurately. On multivariate analysis, last authors were found to be at highest risk for undeclared payments (OR 3.59, 95%CI 2.02-6.20), whereas middle authors were at significantly higher risk for undeclared payments than first authors (OR 1.64, 95%CI 1.04-2.56). CONCLUSIONS: The majority of studies investigating the use of mesh in ventral hernia repairs and abdominal wall reconstructions did not accurately declare COI. Last authors are at highest risk of undisclosed payments. Current policies on disclosing COI seem to be insufficient to ensure transparency of publications.

Axillary lymphadenopathy in a renal cell carcinoma patient after COVID-19 Vaccination.

The distribution of the novel Covid-19 vaccines has been on a scale as unprecedented as the pandemic itself. While the vaccines promise to greatly reduce the spread and impact of the disease, encountering side-effects in clinical practice may pose diagnostic dilemmas. In this case report, we describe a patient with known metastatic renal cell carcinoma who presents with axillary lymphadenopathy found on PET/CT imaging after receiving a Covid-19 vaccine, which was subsequently confirmed to be reactive lymphadenopathy following biopsy.

Readmission following surgical stabilization of rib fractures: Analysis of incidence, cost, and risk factors using the Nationwide Readmissions Database.

BACKGROUND: Surgical stabilization of rib fractures (SSRF) has become increasingly common for the treatment of traumatic rib fractures; however, little is known about related postoperative readmissions. The aims of this study were to determine the rate and cost of readmissions and to identify patient, hospital, and injury characteristics that are associated with risk of readmission in patients who underwent SSRF. The null hypotheses were that readmissions following rib fixation were rare and unrelated to the SSRF complications. METHODS: This is a retrospective analysis of the 2015 to 2017 Nationwide Readmission Database. Adult patients with rib fractures treated by SSRF were included. Univariate and multivariate analyses were used to compare patients readmitted within 30 days with those who were not, based on demographics, comorbidities, and hospital characteristics. Financial information examined included average visit costs and national extrapolations. RESULTS: A total of 2,522 patients who underwent SSRF were included, of whom 276 (10.9%) were readmitted within 30 days. In 36.2% of patients, the reasons for readmissions were related to complications of rib fractures or SSRF. The rest of the patients (63.8%) were readmitted because of mostly nontrauma reasons (32.2%) and new traumatic injuries (21.1%) among other reasons. Multivariate analysis demonstrated that ventilator use, discharge other than home, hospital size, and medical comorbidities were significantly associated with risk of readmission. Nationally, an estimated 2,498 patients undergo SSRF each year, with costs of US $176 million for initial admissions and US $5.9 million for readmissions. CONCLUSION: Readmissions after SSRF are rare and mostly attributed to the reasons not directly related to sequelae of rib fractures or SSRF complications. Interventions aimed at optimizing patients' preexisting medical conditions before discharge should be further investigated as a potential way to decrease rates of readmission after SSRF. LEVEL OF EVIDENCE: Epidemiological study, level III.

Assessment of Conflicts of Interest in Studies of Breast Implants and Breast Implant Mesh.

BACKGROUND: With increased collaboration between surgeons and industry, there has been a push towards improving transparency of conflicts of interest (COI). METHODS: A literature search identified all articles published between 2016 - 2018 involving breast implants/implantable mesh from three major United States plastic surgery journals. Industry payment data from 8 breast implant/implantable mesh companies was collected using the CMS Open Payments database. COI discrepancies were identified by comparing author declaration statements with payments >$100.00 found for the year of publication and year prior. Risk factors for discrepancy were determined at study and author levels. RESULTS: A total of 162 studies (548 authors) were identified. 126 (78%) studies had at least one author receive undisclosed payments. 295 (54%) authors received undisclosed payments. Comparative studies were significantly more likely to have COI discrepancy than non- comparative studies (83% vs 69%, p < 0.05). Multivariate analysis showed no association between COI discrepancy and final product recommendation. Authors who accurately disclosed payments received higher payments compared to authors who did not accurately disclose payments (median $40,349 IQR 7278-190,413 vs median $1300 IQR 429-11,1544, p <0.001). CONCLUSIONS: The majority of breast implant-based studies had undisclosed COIs. Comparative studies were more likely to have COI discrepancy. Authors who accurately disclosed COIs received higher payments than authors with discrepancies. This study highlights the need for increased efforts to improve the transparency of industry sponsorship for breast implant-based studies.

The 5-Factor Modified Frailty Index in the Geriatric Surgical Population.

BACKGROUND: The modified frailty index (mFI-11) is a National Surgical Quality Improvement Program (NSQIP)-based 11-factor index that has been proven to adequately reflect frailty and predict mortality and morbidity. In the past years, certain NSQIP variables have been removed from the database; as of 2015, only 5 out of the original 11 factors remain. While the predictive power and usefulness of this 5-factor index (mFI-5) has been proven in previous work, it has yet to be studied in the geriatrics population. The goal of our study was to compare the mFI-5 to the mFI-11 in terms of value and predictive ability for mortality, postoperative infection, and unplanned 30-day readmission for patients aged 65 years and older. METHODS: Spearman's Rho was calculated to compare the value, and unadjusted and adjusted logistic regressions were created for three outcomes in nine surgical subspecialties. Correlation coefficients were above .86 across all surgical specialties except for cardiac surgery. Adjusted and unadjusted models showed similar C-statistics for mFI-5 and 11. RESULTS: Overall predictive values of geriatric mFI-5 and mFI-11 were lower than those for the general population but still had effective predictive value for mortality and post-operative complications (C-Stat ≥ .7) and weak predictive value for 30-day readmission. CONCLUSIONS: The mFI-5 is an equally effective predictor as the mFI-11 in all subspecialties and an effective predictor of mortality and postoperative complication in the geriatric population. This index has credibility for future use to study frailty within NSQIP, within other databases, and for clinical assessment and use.

Race-based disparities in presentation and outcomes in infrainguinal bypass patients.

BACKGROUND: Racial disparities in healthcare are well documented, however their effects on surgical outcomes remain controversial. While studies have examined outcomes along the white-black dichotomy, Asian populations remain frequently unstudied. We use the VQI to examine disparities among white, black and Asian patients undergoing infrainguinal bypass. METHODS: The VQI database was queried for black, white and Asian patients undergoing infrainguinal surgery between 2012 and 2017. Preoperative characteristics, disease severity, and perioperative characteristics were compared between the racial groups. Primary outcomes included overall mortality, time to death, long term loss of primary patency, and patency at discharge. Analyses were done using a 1:3:3 matched sample of Asian to whites to black patients. RESULTS: Among the patients included, 139 (0.56%) were Asian, 4222 (16.9%) were black and 20,582 (82.5%) were white, of which 129 Asian patients were matched to 387 black and 387 white patients. Asian patients had more advanced disease as demonstrated by higher rates of tissue loss/acute ischemia (P<0.0001) and the highest percentage of below knee popliteal target sites (P=0.0011). There were no differences in mortality (P=0.6808) or long-term loss of primary patency (P=0.4500). However, black patients had higher rates of amputation (OR=1.68, P=0.0224) and reoperation (OR=2.22, P=0.0015). CONCLUSIONS: Asian patients presented with more advanced disease requiring more distal bypass targets. Despite these disparities in presentation, overall long-term primary patency and mortality showed no significant difference.

A Predictive Nomogram for Small Intestine Neuroendocrine Tumors.

OBJECTIVE: There is a scarcity of prognostic tools for small intestine neuroendocrine tumors (SI-NETs) and inconsistencies in currently available grading and staging systems. Nomograms are being proposed to address these limitations. However, none is specific to the US population. This study proposed a concise nomogram for SI-NETs using US population-based data. METHODS: Patients with SI-NETs (2004-2015) were selected from the Surveillance, Epidemiology, and End Results database. Variables selected were age, sex, race, tumor grade, primary tumor size, and TNM staging. Cox regression parameter estimates were used to generate nomogram scores. RESULTS: A total of 2734 patients were selected: 2050 for nomogram development and 684 for internal validation. Prognosticators, age (P < 0.0001), primary tumor size >3 cm (P < 0.0022), tumor grade (P < 0.0001), depth of invasion ≥T3 (P < 0.0280), and distant metastasis (P < 0.0001) were used to develop the nomogram. Nomogram scores ranges from 10 to 80 points with an area under the curve of 0.76, which remained consistently high during internal validation (area under the curve, 0.75). CONCLUSIONS: This Surveillance, Epidemiology, and End Results database nomorgram is a concise prognostic tool that demonstrated high predictive accuracy.

Assessing long term quality of life in geriatric patients after elective laparoscopic cholecystectomy.

INTRODUCTION: While cholecystectomy is shown to be safe in older patients, few existent studies investigate associated quality of life. This study examines quality of life in symptomatic geriatric patients after elective laparoscopic cholecystectomy. METHODS: Patients ≥65 years of age who underwent elective laparoscopic cholecystectomy at a tertiary care center were administered the 12-Item Short Form Survey (SF-12) and a gastrointestinal survey pre-operatively and post-operatively (within 6 and 18 months of surgery). Quality of life characteristics were compared amongst visit type in univariate and multivariate settings, with a mixed-model regression. RESULTS: Our sample included 30 patients. Pain frequency (p = 0.004) and pain severity (p = 0.013) scores improved with each subsequent visit type. SF-12 mental health aggregate score improved overall from pre-operative to long term follow-up (p = 0.0403). DISCUSSION: Our findings suggest that health-related quality of life in geriatric patients improves after elective laparoscopic cholecystectomy in the short and long term. SUMMARY: Quality of life was assessed in symptomatic geriatric patients undergoing elective laparoscopic cholecystectomy. Pain frequency, pain severity, and the SF-12 mental health aggregate scores improved overall from pre-operative to post-operative visit types.

Analysis of Outcomes by Extraction Site following Subtotal Colectomy in Ulcerative Colitis: A Retrospective Cohort Study.

BACKGROUND: Ulcerative colitis frequently requires surgery as a definitive management strategy. The colonic specimen can be extracted from various sites including a midline incision, the stoma site, or a Pfannenstiel incision. It is unclear if one extraction site offers improved outcomes and fewer complications. METHODS: A retrospective review of charts obtained of colorectal surgery patients was conducted for all patients with ulcerative colitis who underwent a subtotal colectomy between 2008 and 2016 at a single tertiary care institution. Demographic data and outcomes data including parastomal and incisional hernias, advanced wound/ostomy certified nurse referrals, surgical site infections, reoperations, and readmissions were collected. Univariate and multivariate analyses were completed to detect any significant differences in outcomes between groups based on extraction site (midline incision, stoma site, or Pfannenstiel incision). RESULTS: Univariate analysis did not show any statistical differences between groups in regard to outcomes. Stoma site extraction did not statistically differ from midline extraction in regard to hernias, advanced ostomy referrals, infections, or reoperations, but midline incision extraction did have a lower risk of readmission (OR = 0.56, p = 0.0066). Pfannenstiel extraction had lower risk of incisional hernias (OR = 0.25, p = 0.0002), advanced ostomy referrals (OR = 0.45, p = 0.0164) and readmission (OR = 0.26, p < 0.0001) as compared to stoma site extraction. CONCLUSIONS: While stoma site extraction can be successfully performed for most patients requiring subtotal colectomy for ulcerative colitis, Pfannenstiel extraction leads to the fewest number of complications and provides the most consistent results.

Impact of Mesenteric Mass in Patients With Midgut Neuroendocrine Tumors.

OBJECTIVES: In this study, we used the institutional pathological and clinical databases from The Mount Sinai Hospital to investigate the impact of mesenteric mass on clinical and staging features in small intestinal neuroendocrine tumors. METHODS: Demographic, clinical, and staging data were collected. Tumor-node-metastasis stage was assigned according to the American Joint Committee on Cancer eighth edition staging manual. We used a χ-square test to evaluate the association between mesenteric mass and presenting symptoms, as well as the association between mesenteric mass and tumor characteristics, type of surgical resection, and use of somatostatin analogues. RESULTS: Presence of mesenteric mass was strongly associated with highly symptomatic clinical presentation (P < 0.0001). Patients with a mesenteric mass were more likely to have more advanced tumor status (T3 and T4; P = 0.005). The presence of a mesenteric mass was also more strongly associated with metastatic disease (P = 0.002). Patients with a mesenteric mass were more likely to undergo extensive surgical resection (P < 0.0001) and be treated with somatostatin analogues (P < 0.003). CONCLUSIONS: The data confirm our clinical observations that mesenteric involvement represents more extensive disease and is also associated with more aggressive treatment.

Predicting Survival of Small Intestine Neuroendocrine Tumors: Experience From a Major Referral Center.

OBJECTIVE: Neuroendocrine tumors (NETs) comprise 41.8% of small intestine malignancies. The NET nomogram is a 15-item prognostic tool that includes relevant factors for guiding management decisions. This is the first external validation of this tool among American patients at a tertiary treatment center. METHODS: Patients who underwent surgical intervention from 2005 to 2017 were screened by retrospective chart review. Nomogram scores were calculated following the methods outlined by Modlin et al (Neuroendocrinology. 2010;92:143-157). Validation assessed the association between nomogram scores and survival using Wilcoxon test and Cox regression. RESULTS: Among the 121 patients selected, the NET nomogram significantly predicted survival as a continuous variable (P < 0.01) and when dichotomized using 83 points to distinguish low-risk versus high-risk groups (P < 0.01). However, the nomogram was not universally applicable as even at our specialty center, variables such as chromogranin A and urinary 5-hydroxyindoleacetic acid are not routinely collected, whereas others, like tumor grade, do not reflect the most recently updated classifications. CONCLUSION: The NET nomogram accurately identified patients at low and high risk of death. However, revision to update prognosticators could improve its usefulness for predicting survival of small intestine NETs.

Age stratified analysis of pre-operative factors impacting unplanned thirty day readmission in geriatric general surgery.

BACKGROUND: The geriatrics population can no longer be considered as one homogenous group when it comes to patient-centric and value-based care. We aim to determine if there are pre-operative factors which differ between geriatric age strata (65-74, 75-84, 85 + years) that impact unplanned thirty-day readmission. METHODS: 2015 NSQIP general surgery procedure data was utilized. Chi Square and t-tests were utilized to see if certain pre-operative factors impacted readmission. Regressions with age strata as an interaction term were run to determine if age was an effect-modifier. Significant pre-operative factors were included in a multivariate model with step-wise selection for significant age-stratification interaction terms. RESULTS: Gender, inpatient status, wound classification, disseminated cancer, origin status, functional status, and RVU were significantly impacted by age strata in unadjusted models. Gender, inpatient status, emergency, and transfer/origin status were significant in our adjusted model. CONCLUSIONS: Exogenous variables between age strata significantly impact unplanned thirty-day readmission in comparison to differing co-morbidity and symptomatology.