Neel A. Mansukhani

Determining If Sex Bias Exists in Human Surgical Clinical Research.

Importance Sex is a variable that is poorly controlled for in clinical research. Objectives To determine if sex bias exists in human surgical clinical research, to determine if data are reported and analyzed using sex as an independent variable, and to identify specialties in which the greatest and least sex biases exist. Design, Setting, and Participants For this bibliometric analysis, data were abstracted from 1303 original peer-reviewed articles published from January 1, 2011, through December 31, 2012, in 5 surgery journals. Main Outcomes and Measures Study type, location, number and sex of participants, degree of sex matching of included participants, and inclusion of sex-based reporting, statistical analysis, and discussion of data. Results Of 2347 articles reviewed, 1668 (71.1%) included human participants. After excluding 365 articles, 1303 remained: 17 (1.3%) included males only, 41 (3.1%) included females only, 1020 (78.3%) included males and females, and 225 (17.3%) did not document the sex of the participants. Although female participants represent more than 50% (n = 57 688 606) of the total number (115 377 213) included, considerable variability existed with the number of male (46 111 818), female (58 805 665), and unspecified (10 459 730) participants included among the journals, between US domestic and international studies, and between single vs multicenter studies. For articles included in the study, 38.1% (497 of 1303) reported these data by sex, 33.2% (432 of 1303) analyzed these data by sex, and 22.9% (299 of 1303) included a discussion of sex-based results. Sex matching of the included participants in the research overall was poor, with 45.2% (589 of 1303) of the studies matching the inclusion of both sexes by 50%. During analysis of the different surgical specialties, a wide variation in sex-based inclusion, matching, and data reporting existed, with colorectal surgery having the best matching of male and female participants and cardiac surgery having the worst. Conclusions and Relevance Sex bias exists in human surgical clinical research. Few studies included men and women equally, less than one-third performed data analysis by sex, and there was wide variation in inclusion and matching of the sexes among the specialties and the journals reviewed. Because clinical research is the foundation for evidence-based medicine, it is imperative that this disparity be addressed so that therapies benefit both sexes.

Association of Author Gender With Sex Bias in Surgical Research

Importance Previous studies demonstrate sex bias in surgical research. Female participants and investigators are underrepresented in surgical scientific research. Objectives To describe the distribution of male and female authors in 5 general-interest surgery journals, assess the association of author gender with sex bias, and explore whether investigators benefit from performing sex-inclusion research. Design, Setting, and Participants For this bibliometric analysis, data were abstracted from 1921 original, peer-reviewed articles published from January 1, 2011, through December 31, 2012, in Annals of Surgery, American Journal of Surgery, JAMA Surgery, The Journal of Surgical Research, and Surgery. Excluded articles pertained to a sex-specific disease or did not report the number of study participants. An additional 119 articles contained gender-ambiguous author names and were omitted. Data were analyzed from April to June 2017. Main Outcomes and Measures Male and female first and senior authors, number of female and male participants in each study, surgical specialty, and number of citations received per article. Results Of the 3604 authors of 1802 articles included in this study, 2791 first and senior authors (77.4%) were male and 813 (22.6%) were female. The prevalence of male and female authors was consistent across all 5 journals and among clinical and basic science research. Articles by female authors included a higher median number of female study participants compared with their male counterparts (27.5 vs 16.0; P = .01), but sex matched the inclusion of participants less frequently (36% vs 45%; P = .001). No sex-based differences occurred between male and female authors in reporting, statistical analysis, and discussion of the data or in the number of citations received. Compared with studies that did not report, analyze, or discuss data by sex, studies that performed sex-specific data reporting yielded a mean of 2.8 more citations (95% CI, 1.2-4.4; P = .001); those that performed statistical analysis, a mean of 3.5 more citations (95% CI, 1.8-5.1; P = .001); and those that discussed the data, a mean of 2.6 more citations (95% CI, 0.7-4.5; P = .001). Articles with a higher percentage of sex matching of participants also received more citations, with an increase of 1 citation per 4.8% (95% CI, 2.0%-7.7%; P = .001) increase in percentage of sex matching. Conclusions and Relevance Sex bias in surgical research is prevalent among male and female authors; however, female authors included proportionally more female participants in their studies compared with male authors. Notably, studies that addressed sex bias were rewarded by the scientific community with increased citations of their published work.

Ten-year review of isolated spontaneous mesenteric arterial dissections

Objective: Isolated spontaneous dissection of the superior mesenteric artery (SMA) and celiac artery (CA) remains a rare condition; however, it has been increasingly noted incidentally on diagnostic imaging. The purpose of this study was to examine the natural history and outcomes of patients presenting with isolated spontaneous mesenteric artery dissection (SMAD). We hypothesized that most SMADs can be treated nonoperatively. Methods: This was a single‐center retrospective review of patients presenting with the diagnosis of SMAD between 2006 and 2016. Data analysis included demographics, clinical data, radiologic review, treatment, and outcomes. Results: A total of 77 patients were found to have CA dissection, SMA dissection, or both in the absence of aortic dissection diagnosed on computed tomography or magnetic resonance imaging. The average age was 56 years (range, 26–86 years), 80% were male, and 10 patients (13%) had underlying connective tissue disorders. The majority, 64%, presented with symptoms including abdominal pain, back pain, and chest pain; the remaining 36% were asymptomatic. Combined SMA and CA dissection was found in 14 (18%) patients; 33 (43%) presented with isolated CA dissection, and 30 (39%) presented with isolated SMA dissection. Only four patients required intervention. Mesenteric bypass was performed in two patients, and SMA endarterectomy with patch angioplasty was performed in one patient for signs of bowel ischemia. No patient required bowel resection. The two bypasses were anastomosed to a branch of the SMA, and complete lumen restoration was seen on long‐term imaging follow‐up. One patient underwent stent grafting of the CA and hepatic artery for aneurysmal degeneration 1 month after diagnosis. The remaining 73 patients were managed nonoperatively; 40 (52%) were treated with a short course of anticoagulation, 23 (30%) were treated with antiplatelet therapy, and 10 (13%) were treated with observation alone. No other late interventions or recurrences were noted during a mean follow‐up of 21 months. Conclusions: Whereas isolated SMAD poses a risk of visceral ischemia, most patients presenting with this diagnosis can be treated nonoperatively with a short course of antiplatelet or anticoagulant therapy. Only a small number of patients require surgical revascularization for bowel ischemia.

IP137. Outcomes of Interfacility Transfer Patients Compared with Primarily Admitted Patients in Vascular Surgery to a Tertiary Academic Referral Center

indicated care managers identified marginally more superficial wounds in the THEM group (31.3% vs 7.1%; P 1⁄4 .175). Both groups reported an increase in the 8-Item Short Form Health Survey physical summary scores, but it was more pronounced in THEM patients (P 1⁄4 .076). THEM patients reported a significantly greater improvement in quality of life on two of the 8-Item Short Form Health Survey quality subscales (roledphysical [THEM, 8.7; control, 1.1] and roleeemotional [THEM, 6.1; control, 0.5]; both P < .05). THEM patients reported trends for higher satisfaction in terms of general satisfaction, technical quality, and accessibility for Patient Satisfaction Questionnaire Short Form survey questions (4.2 vs 3.7 [P 1⁄4 .72], 4.5 vs 4.1 [P 1⁄4 .81], and 4.2 vs 3.8 [P 1⁄4 .63]), respectively. Conclusions: THEM was technically feasible and provided significant benefit to patients in geographically disparate areas. THEM was associated with increased patient satisfaction. Additional findings suggested that THEM patients embraced telehealth technology and took advantage of increased access to health care professionals. Telehealth successfully merged remotely generated information with care manager interaction. Presently, a larger study, preferably multicenter, is warranted and under consideration.

Aorta-innominate bypass through ministernotomy

&NA; Atherosclerotic innominate artery occlusive disease can lead to cerebral and upper extremity ischemia. Innominate artery angioplasty and stenting can be complicated by stent fractures and restenosis; furthermore, this technique is limited in treatment of innominate artery occlusions. Ministernotomy to the second or third intercostal space can be used instead of conventional full sternotomy for open surgical revascularization of the innominate artery with excellent perioperative and long‐term outcomes. This series of three consecutive patients highlights the technique of aorta‐innominate artery bypass through ministernotomy.

Peptide Amphiphile Nanostructures for Targeting of Atherosclerotic Plaque and Drug Delivery

Coassembled peptide amphiphile nanofibers designed to target atherosclerotic plaque and enhance cholesterol efflux are shown to encapsulate and deliver a liver X receptor agonist to increase efflux from murine macrophages in vitro. Fluorescence microscopy reveals that the nanofibers, which display an apolipoprotein‐mimetic peptide, localize at plaque sites in low density lipoprotein receptor knockout (LDLR KO) mice with or without the encapsulated molecule, while nanofibers displaying a scrambled, nontargeting peptide sequence do not demonstrate comparable binding. These results show that nanofibers functionalized with apolipoprotein‐mimetic peptides may be effective vehicles for intravascular targeted drug delivery to treat atherosclerosis.

The enduring patency of primary inferior vena cava repair

Background. Inferior vena cava repair after planned and unplanned venotomy is performed by either interposition bypass, patch venopasty, or lateral venorrhaphy and primary repair. Primary repair of the inferior vena cava avoids the use of foreign material and allows an all‐autologous repair in an expeditious fashion. The purpose of this study was to demonstrate the utility of inferior vena cava repair, determine the degree of inferior vena cava stenosis, and examine clinical outcomes after primary repair. Methods. We conducted a single‐center retrospective review of patients who underwent primary inferior vena cava repairs between January 2002 and January 2014 at a tertiary care center. Primary repair followed lateral venorrhaphy for tumor extraction or for repair of an iatrogenic inferior vena cava injury. Patient demographics, cross‐sectional vena cava dimensions, and patient outcomes were tabulated. Results. In total, 47 (30 men and 17 women) patients underwent primary inferior vena cava repair (median age 58 years, range 31–83 years). Twenty‐six patients (15 men and 11 women) underwent en bloc radical nephrectomy, inferior vena cava tumor thrombus extraction, and primary lateral venorrhaphy (median age 61 years, range 39–83 years). The majority, 92% of these patients, had renal cell carcinoma on final pathology, with a median follow‐up period of 39 months (range 1–108 months). Twenty‐one patients (15 men and 6 women) underwent primary repair for iatrogenic inferior vena cava injury (median age 54 years, range 31–82 years). The median follow‐up period was 18.5 months (3–110 months). Clinic follow‐up with postoperative imaging was obtained in 76.9% of those undergoing tumor thrombus extraction (n = 20) and 76.2% of those undergoing repair of an iatrogenic injury (n = 16). Overall, there was a 13% infrarenal inferior vena cava diameter loss, 17% inferior vena cava diameter loss at the level of the renal veins, and 10% suprarenal inferior vena cava diameter loss when comparing postoperative with preoperative imaging. All patients remained asymptomatic; therefore, inferior vena cava narrowing associated with primary repair was clinically insignificant. Conclusion. Primary inferior vena cava repair is associated with less than 20% inferior vena cava diameter loss and does not compromise venous outflow from the extremities. Primary inferior vena cava repair is a safe and expeditious technique that provides excellent clinical outcomes and long‐term patency.

Response: Rebranding “The Lab Years” as “Professional Development” in Order to Redefine the Modern Surgeon Scientist

PERSPECTIVE T he uniqueness of surgical training comes from the privilege of providing surgical care to patients combined with the capability to perform innovative research with the potential of improving surgical practice. Surgical residency, in fact, exposes residents to sick and complex patients on a daily basis, and makes the gaps in contemporary treatment painfully obvious, therefore presenting a plethora of opportunities for innovation and progress. Because of their scientific education and clinical background, surgeons are uniquely poised to perform highly influential investigative work. From a reviewer of the scientific literature, to a site investigator for an industry sponsored device trial, to an independently funded basic and translational science researcher, the surgeon’s contributions are highly valuable. Dedicated time in ‘‘the lab’’ during residency is often perceived by outsiders and thought of by surgical trainees as mandatory servitude to the academic faculty, ‘‘time off,’’ or an opportunity to earn supplemental moonlighting income. Pessimism by faculty and staff, which is inadvertently cultivated during surgical training, is often diffused to surgical trainees and weakens the image of the academic surgeon and surgeon scientist. This trend is compounded by steadily decreasing federal funding for surgeon scientists and shifts to productivity-based compensation models that result in increased pressure to produce work relative value units. Furthermore, to expedite training and address a workforce shortage, new surgical training models including integrated vascular surgery, integrated thoracic surgery, integrated plastic surgery, and general surgery with early specialization options commonly eliminate dedicated and protected time for research. Expedited surgical training adds the temptation of increased income potential in the form of faster time to practice from medical school which is understandably pursued by medical students in the current climate of soaring costs for medical education. Therefore, developing the skills to perform high impact work needs to be emphasized in surgical training, and

A Tailorable In Situ Light-Activated Biodegradable Vascular Scaffold

Biodegradable vascular scaffolds (BVS) are novel treatments for obstructive atherosclerotic cardiovascular disease that have been developed to overcome the limitations of traditional metallic drug-eluting stents (DES). The mechanical properties of bioabsorbable polymers used for the production of novel BVS are a key consideration for the clinical translation of this emerging technology. Herein, we describe the engineering of an in situ light-activated vascular scaffold (ILVS) comprised of a biodegradable citric acid-based elastomeric polymer, referred to as methacrylated poly-diol citrate (mPDC), and a diazeniumdiolate chitosan nitric oxide donor (chitoNO). In vitro studies demonstrate that the mechanical properties of the ILVS can be tailored to meet or exceed those of commercially available self-expanding bare metal stents (BMS). The radial compression strength of the ILVS is higher than that of a BMS despite undergoing degradation at physiologic conditions for 7 months. ILVS containing chitoNO provides sustained supraphysiologic levels of NO release. Lastly, ILVS were successfully cast in porcine arteries ex vivo using a custom designed triple balloon catheter, demonstrating translational potential. In conclusion, these data demonstrate the ability of an ILVS to provide tunable mechanical properties and drug-delivery capabilities for the vasculature, and thereby support mPDC as a promising material for the development of novel BVS platforms.