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1.
J Vasc Surg ; 2024 Jun 18.
Article in English | MEDLINE | ID: mdl-38901638

ABSTRACT

OBJECTIVE: To examine sex in human vascular surgery research by quantifying the inclusion and analysis of sex-based data in high-impact vascular surgery journals. METHODS: A bibliographic review of original articles published in the European Journal of Vascular and Endovascular Surgery, Journal of Vascular Surgery, JVS: Venous and Lymphatic Disorders, Journal of Endovascular Therapy, and Annals of Vascular Surgery from January 1, 2018, to December 31, 2020, and from January 1, 2023, to December 31, 2023, was conducted. Abstracted data included sex-based data analysis, inclusion of sex as a variable in multivariable analysis, inclusion of sex as an independent variable, and a discussion of sex-based results. RESULTS: Of the 3762 articles that included human, animal, or cell subjects, 249 (6.6%) did not state sex. Of those 249 articles, 183 included human subjects, 55 included animal subjects, and 11 used cell lines as the subjects. These were removed from analysis as well as the remaining 68 articles with animal subjects. In addition, 23 researched a sex-specific pathology and were removed from analysis. Of the remaining 3422 articles included in our study, 42.3% analyzed sex, 46.9% included sex in multivariable analysis, 4.8% included sex as an independent variable, and 26.6% included a discussion of sex. There were no significant differences in all four sex variables between 2018, 2019, and 2020. Between 2018-2020 and 2023, there were significant increases in all four sex variables. Multicenter studies had significantly higher rates of independent analysis of sex over single-center studies (7.4% vs 3.3%, P < .001). There was no significant difference in independent analysis of sex between U.S.-based and non-U.S.-based studies. Only 191 articles (5.6%) had 90% or greater matching of men and women in their study. CONCLUSIONS: Equitable inclusion and analysis of sex is rare in vascular surgery research. Less than 5% of articles included an independent analysis of data by sex, and few studies included males and females equally. Clinical research is the basis for evidence-based medicine; therefore, it is important to strive for equitable inclusion, analysis, and reporting of data to foster generalizability of clinical research to men and women.

2.
J Vasc Surg Cases Innov Tech ; 9(4): 101308, 2023 Dec.
Article in English | MEDLINE | ID: mdl-38034594

ABSTRACT

We present a rare manifestation of a common pathology: left sided sensorineural hearing loss secondary to subclavian steal syndrome after thoracic endovascular aortic repair for complicated acute aortic dissection. We describe the vascular physiology that can result in unilateral hearing loss and provide a brief review of subclavian steal syndrome. This case report highlights the importance of avid clinical recognition of an atypical presentation of a common vascular disease.

3.
Ann Vasc Surg ; 104: 27-37, 2023 Jun 24.
Article in English | MEDLINE | ID: mdl-37356651

ABSTRACT

BACKGROUND: Elective endovascular abdominal aortic aneurysm repair (EVAR) can be performed safely with a short postoperative length of stay (LOS). We aimed to develop and assess the impact of an enhanced recovery protocol (ERP) on LOS after elective EVAR. METHODS: Pre-ERP development single center retrospective review of elective EVAR procedures from January 2012 to December 2019. ERP was developed by targeting factors associated with prolonged LOS (>2 days) elucidated from semistructured interviews and Bayesian additive regression tree analysis. Post-ERP development, a subsequent retrospective review of elective EVAR performed from January 2018 to June 2021 was performed to evaluate LOS before and after ERP. Primary outcome was LOS. RESULTS: Two hundred sixteen patients underwent elective infrarenal EVAR from 2012 to 2019. Periprocedural factors identified as associated with LOS >2 days included noncommercial insurance (43.6% vs. 26.5%; P = 0.01), preoperative anemia (hemoglobin 12.56 g/dL vs. 13.57 g/dL; P = 0.001), worse renal function (creatinine 1.31 mg/dL vs. 1.01/dL; P = 0.004), open femoral access (74.4% vs. 26.5%; P < 0.001), intensive care unit (ICU) stay (2.7 days vs. 0.9 days; P < 0.001), postoperative anemia (9.8 g/dL vs. 11.9 g/dL; P < 0.001), postoperative creatinine (1.55 mg/dL vs. 0.97 mg/dL; P < 0.001), and beta blocker need on discharge (45.5% vs. 25%; P = 0.003) as significant between patients with short and prolonged LOS groups. Semistructured interviews revealed postoperative day 1 complete blood count/chemistry, postoperative physical therapy evaluation, ICU admission, urinary retention, patient expectations, and unavailability of transportation home as modifiable factors that delayed early discharge. A 14-component ERP was created to target the factors identified from combined qualitative and quantitative results. Post-ERP development, 74 elective EVAR patients were reviewed from 2018 to 2021 (37 pre-ERP and 37 post-ERP). Following ERP development, the mean LOS was reduced from 2.6 (standard deviation: 1.9) to 1.3 days (standard deviation: 1.3); P < 0.01. There were no significant differences in 30-day readmission, postoperative complications, emergency room visits, or 90-day mortality before and after the ERP was used. CONCLUSIONS: Practice and procedural factors can be modified through an informed and safe process to reduce LOS after elective EVAR. LOS following elective EVAR was safely reduced following the use of a systematically developed ERP.

4.
J Vasc Surg ; 78(2): 351-361, 2023 08.
Article in English | MEDLINE | ID: mdl-37086823

ABSTRACT

INTRODUCTION: Type 2 endoleak (T2EL) is the most common adverse finding on postoperative surveillance after endovascular aortic aneurysm repair (EVAR). A low rate of aneurysm-related mortality with T2EL has been established. However, the optimal management strategy and the efficacy of reintervention remain controversial. This study used data from the Vascular Quality Initiative linked to Medicare claims (VQI-Medicare) to evaluate T2LE in a real-world cohort. METHODS: This retrospective review of EVAR procedures in VQI-Medicare included patients undergoing their first EVAR procedure between 2015 and 2017. Patients with an endoleak other than T2EL on completion angiogram and those without VQI imaging follow-up were excluded. Patients without Medicare part A or part B enrollment at the time of the procedure or without 1-year complete Medicare follow-up data were also excluded. The exposure variable was T2EL, defined as any branch vessel flow detected within the first postoperative year. Outcomes of interest were mortality, reintervention, T2EL-related reintervention, post-EVAR imaging, and T2EL behavior including spontaneous resolution, aneurysm sac regression, and resolution after reintervention. The association of prophylactic branch vessel embolization (PBE) with T2EL resolution and aneurysm sac regression was also evaluated. RESULTS: In a final cohort of 5534 patients, 1372 (24.7%) had an identified T2EL and 4162 (75.2%) did not. The median age of patients with and without T2EL was 77 and 75 years, respectively. There were no differences in mortality, imaging, reintervention, or T2EL-related reintervention at 3 years after the procedure for patients with T2EL. The aneurysm sac diameter decreased by 4 mm (range: 9-0 mm decrease) in the total cohort. Patients with inferior mesenteric artery-based T2EL had the smallest decrease in aneurysm diameter (median 1 mm decrease compared with 1.5 mm for accessory renal artery-based T2EL, 2 mm for multiple feeding vessel-based T2EL, and 4 mm for lumbar artery-based T2EL; P < .001). Spontaneous resolution occurred in 73.7% of patients (n = 809). T2ELs with evidence of multiple feeding vessels were associated with the lowest rate of spontaneous resolution (n = 51, 54.9%), compared with those with a single identified feeding vessel of inferior mesenteric artery (n = 99, 60.0%), lumbar artery (n = 655, 77.7%), or accessory renal artery (n = 31, 79.5%) (P < .001). PBE was performed in 84 patients. Patients who underwent PBE and were without detectable T2EL after EVAR had the greatest rate of sac regression at follow-up (7 mm decrease) compared with baseline. CONCLUSIONS: T2EL after EVAR is associated with high rates of spontaneous resolution, low rates of aneurysm sac growth, and no evidence of increased early mortality or reintervention. PBE in conjunction with EVAR may be indicated in some circumstances.


Subject(s)
Aortic Aneurysm, Abdominal , Blood Vessel Prosthesis Implantation , Endovascular Procedures , Humans , Aged , United States/epidemiology , Endoleak/diagnostic imaging , Endoleak/etiology , Endoleak/therapy , Incidence , Blood Vessel Prosthesis Implantation/adverse effects , Risk Factors , Endovascular Procedures/adverse effects , Treatment Outcome , Medicare , Retrospective Studies , Aortic Aneurysm, Abdominal/diagnostic imaging , Aortic Aneurysm, Abdominal/surgery , Aortic Aneurysm, Abdominal/complications
5.
J Vasc Res ; 59(5): 314-323, 2022.
Article in English | MEDLINE | ID: mdl-36067740

ABSTRACT

INTRODUCTION: This study investigated whether a novel therapy called ischemic conditioning (IC) improves walking capacity and lower extremity muscle performance in patients with peripheral vascular disease who experience intermittent claudication. METHODS: Forty-three patients with claudication were enrolled and received either IC or IC Sham for 2 weeks in this randomized, controlled, double-blinded, prospective study. IC sessions involved five cycles of alternating 5-min inflations of a blood pressure cuff to 225 mm Hg (25 mm Hg for IC Sham) and 5-min deflations, around the thigh of the affected lower extremity. RESULTS: There was no difference in the change in claudication onset time (Δ = 114 ± 212 s IC vs. 104 ± 173 s IC Sham; p = 0.67) or peak walking time (Δ = 42 ± 139 s IC vs. 12 ± 148 s IC Sham; p = 0.35) between the IC and IC Sham groups. At the level of the knee, participants in the IC group performed more work (Δ = 3,029 ± 4,999 J IC vs. 345 ± 2,863 J IC Sham; p = 0.03) and displayed a greater time to muscle fatigue (Δ = 147 ± 221 s IC vs. -27 ± 236 s IC Sham; p = 0.01). DISCUSSION/CONCLUSION: In patients with claudication, IC improved total work performed and time to fatigue at the knee but did not change walking parameters.


Subject(s)
Intermittent Claudication , Muscle, Skeletal , Walking , Humans , Intermittent Claudication/diagnosis , Intermittent Claudication/therapy , Ischemia , Lower Extremity/blood supply , Pilot Projects , Prospective Studies , Walking/physiology
6.
Ann Vasc Surg ; 81: 273-282, 2022 Apr.
Article in English | MEDLINE | ID: mdl-34775009

ABSTRACT

OBJECTIVE: Segmental Arterial Mediolysis (SAM) is a rare, poorly understood vasculopathy that involves vacuolization of the arterial wall, most commonly of the visceral arteries. There are no established therapeutic or monitoring guidelines for SAM, and intervention typically depends on patient presentation. The purpose of this study is to review the management and outcomes of patients with this rare vascular disease METHODS: Single center retrospective review of patients diagnosed with SAM between 2011 and 2019. Included were patients with radiological diagnosis of SAM. Demographic factors, past medical history, presenting symptoms, affected vessels, management, and lesion characteristics over time were collected. Demographic and periprocedural factors, and medical management strategies were compared for those who required operative intervention versus those managed non-operatively. RESULTS: Thirty patients were included, 21 (70%) were male, mean age was 53.5 years (range: 35.7-72.2). Twenty-seven patients were managed non-operatively, 3 patients required surgical intervention. Patients who underwent operative intervention were more likely to present with pain >30 days (P < 0.05), and hemorrhage (P < 0.01). Abdominal pain was the most common presenting symptom (n = 24, 80%). Arterial dissection was the most common radiological finding at time of presentation (n = 20, 67%). The celiac artery and its branches were most often involved (n=22, 73%) followed by the superior mesenteric artery and its branches (n = 15, 50%). Non-operative management most often consisted of anti-hypertensive therapy (n = 13, 43%), antiplatelet agents (n = 17, 57%%), and lipid-lowering agents (n = 13, 43%), with 7 patients receiving all three. Six patients demonstrated confirmed resolution of lesions during surveillance imaging, with average time to resolution of 325.5 days. CONCLUSIONS: Patients who underwent intervention for SAM presented with either mesenteric ischemia or pseudoaneurysm rupture. In patients that present without those conditions, medical management consisting of anti-hypertensives, antiplatelet agents, and lipid-lowering therapy was effective. Non operative management resulted in symptom resolution in all patients and surveillance imaging showed resolution of radiographic abnormalities in 6 patients out of 27 at less than one year.


Subject(s)
Aortic Dissection , Mesenteric Ischemia , Adult , Aged , Aortic Dissection/diagnostic imaging , Aortic Dissection/therapy , Celiac Artery/diagnostic imaging , Celiac Artery/surgery , Female , Humans , Male , Mesenteric Artery, Superior/surgery , Middle Aged , Treatment Outcome
7.
J Vasc Surg Cases Innov Tech ; 7(4): 794-797, 2021 Dec.
Article in English | MEDLINE | ID: mdl-34877440

ABSTRACT

The superficial femoral artery is a common location for endovascular treatment of occlusive arterial disease. Stent extrusion is an uncommon complication of stent placement. In the present case report, we sought to raise awareness of this rare complication and have described the management of a single unique case. Although rare, the complication of stent extrusion should be considered in patients with abnormal symptoms after endovascular treatment of superficial femoral artery disease.

8.
J Vasc Surg Cases Innov Tech ; 7(3): 429-432, 2021 Sep.
Article in English | MEDLINE | ID: mdl-34278077

ABSTRACT

Aortic thrombus with multilevel acute ischemia is rare. We report the use of vacuum-assisted thrombectomy of an aortic mural thrombus with superior mesenteric artery involvement causing bilateral lower extremity ischemia and acute mesenteric ischemia, in conjunction with embolectomy and fasciotomy. We describe the novel use of the AngioVac device (AngioDynamics, Latham, NY) for reperfusion in the systemic arterial circulation. This case report demonstrates a feasible and less invasive alternative to the management of aortic thrombi with acute ischemia in patients unfit for open aortic thrombectomy of the visceral segment aorta.

9.
J Vasc Surg Cases Innov Tech ; 6(2): 254-258, 2020 Jun.
Article in English | MEDLINE | ID: mdl-32490298

ABSTRACT

Endovascular treatment of aortic dissection may be complicated by challenges to navigating the true lumen. In this report, we describe treatment of a type B dissection after open type A repair with aneurysmal degeneration, a short-segment occluded true lumen, and a distal re-entry tear near the celiac artery origin. Endovascular septal fenestration and subsequent thoracic endovascular aortic repair were used to bypass the short-segment midthoracic aortic occlusion, successfully excluding the thoracic aortic aneurysm. The patient was discharged without complications, and follow-up imaging demonstrated favorable aortic remodeling. The case demonstrates feasibility of an endovascular bypass of an intervening short-segment occluded true lumen using a thoracic endovascular aortic repair with true-false-true lumen deployment.

10.
J Surg Res ; 254: 242-246, 2020 10.
Article in English | MEDLINE | ID: mdl-32480067

ABSTRACT

BACKGROUND: Academic journals have adopted strict authorship guidelines to eliminate the addition of authors who have not met criteria, also known as "courtesy authors." We sought to analyze current perceptions, practices, and academic rank-related variations in courtesy authorship use among modern surgical journals. METHODS: Authors who published original research articles in 2014-2015 in eight surgical journals were surveyed and categorized as junior (JF) or senior faculty (SF) by years in practice. Responses regarding courtesy authorship perceptions and practices were analyzed. Subanalyses were performed based on journal impact factor. RESULTS: A total of 455 authors responded (34% JF versus 66% SF). SF were older (52 versus 39 y) and more predominantly male (80% versus 61%) versus JF. JF more frequently added a courtesy author to the index publication versus SF (23% versus 13%, P = 0.02), but had similar historical rates of adding courtesy authors (58% versus 51%, P = not significant) or being added as a courtesy author (29% versus 37%, P = not significant). JF felt courtesy authorship was more common in their practice and felt more pressure by superiors to add courtesy authors. Perceptions regarding the practice of courtesy authorship differed significantly, with 70% of JF feeling courtesy authorship use has not declined versus 45% of SF (P < 0.05). Both JF and SF cited courtesy authorship positives, including avoiding author conflicts (17% versus 33%, respectively) and increasing morale (25% versus 45%, respectively). CONCLUSIONS: Courtesy authorship use continues to be common among both JF and SF. However, perceptions about the benefits, harms, and pressures vary significantly by academic rank and with journal impact factor.


Subject(s)
Authorship/standards , General Surgery , Periodicals as Topic , Female , Humans , Male
11.
Med Devices (Auckl) ; 12: 461-467, 2019.
Article in English | MEDLINE | ID: mdl-31814779

ABSTRACT

PURPOSE: The purpose of this study is to identify adverse events (device- and patient-related) associated with thoracic aortic stent graft systems and their timing post-procedure. MATERIALS AND METHODS: The Food and Drug Administration's Manufacturer and User Facility Device Experience (FDA-MAUDE) voluntary database was searched for Thoracic Aortic Endovascular Repair (TEVAR) devices reported over the course of 1 year (January 1, 2014 to December 31, 2014). The data abstracted included the indication for treatment, device used, and adverse events. RESULTS: During 2014, there were 334 original submissions to the FDA-MAUDE database describing 371 adverse events regarding TEVAR devices that met inclusion criteria for this study. All submissions were from manufacturers, and none were from physicians. The most common pathologies treated were thoracic aortic aneurysm (67.6%) and type B aortic dissection (25.1%). The most frequently reported intraoperative, early postoperative (<30 days), and late postoperative (>30 days) events overall were technical device failure, neurologic complications (stroke, paraplegia), and endoleak, respectively. Of note, there were descriptions of retained deployment materials, late graft infections, and aorto-visceral fistula formation up to 3 years postoperatively. CONCLUSION: The MAUDE database is a valuable repository for complications and device failures that are not otherwise in the published literature and submitted by manufacturers relating to this relatively new technology.

12.
J Vasc Surg Cases Innov Tech ; 5(4): 447-451, 2019 Dec.
Article in English | MEDLINE | ID: mdl-31660470

ABSTRACT

Celiac artery aneurysms (CAAs) are rare but potentially devastating lesions. Given the high rates of mortality on rupture at large sizes, they should be treated promptly with either surgical or endovascular interventions in appropriate-risk patients. Several options exist for treatment, including surgical repair and endovascular embolization with or without stent or stent graft placement. Because of their rarity, there are few reports of successfully treated CAA lesions. Herein, we describe successful endovascular treatment of one of the largest CAAs reported in the literature.

13.
Macromol Biosci ; 19(6): e1900066, 2019 06.
Article in English | MEDLINE | ID: mdl-31066494

ABSTRACT

The rising prevalence of cardiovascular disease worldwide necessitates novel therapeutic approaches to manage atherosclerosis. Intravenously administered nanostructures are a promising noninvasive approach to deliver therapeutics that reduce plaque burden. The drug liver X receptor agonist GW3965 (LXR) can reduce atherosclerosis by promoting cholesterol efflux from plaque but causes liver toxicity when administered systemically at effective doses, thus preventing its clinical use. The ability of peptide amphiphile nanofibers containing apolipoprotein A1-derived targeting peptide 4F to serve as nanocarriers for LXR delivery (ApoA1-LXR PA) in vivo is investigated here. These nanostructures are found to successfully target atherosclerotic lesions in a mouse model within 24 h of injection. After 8 weeks of intravenous administration, the nanostructures significantly reduce plaque burden in both male and female mice to a similar extent as LXR alone in comparison to saline-treated controls. Furthermore, they do not cause increased liver toxicity in comparison to LXR treatments, which may be related to more controlled release by the nanostructure. These findings demonstrate the potential of supramolecular nanostructures as safe, effective drug nanocarriers to manage atherosclerosis.


Subject(s)
Apolipoprotein A-I/pharmacology , Atherosclerosis/drug therapy , Liver X Receptors/chemistry , Peptides/pharmacology , Animals , Apolipoprotein A-I/chemistry , Atherosclerosis/genetics , Benzoates/adverse effects , Benzoates/chemistry , Benzylamines/adverse effects , Benzylamines/chemistry , Disease Models, Animal , Humans , Liver X Receptors/genetics , Liver X Receptors/therapeutic use , Mice , Molecular Targeted Therapy , Nanofibers/chemistry , Nanostructures/chemistry , Nanostructures/therapeutic use , Peptides/chemistry , Surface-Active Agents/chemistry , Surface-Active Agents/pharmacology
14.
Ann Vasc Surg ; 54: 27-32, 2019 Jan.
Article in English | MEDLINE | ID: mdl-30253190

ABSTRACT

BACKGROUND: Endovascular aortic aneurysm repair (EVAR) is the preferred first-line treatment for abdominal aortic aneurysms. Current postprocedure surveillance recommendations by manufacturers are a 1-month computed tomography angiography (CTA) followed by a 12-month CTA in most circumstances. The objective of this study is to determine the utility of the 1-month CTA following elective EVAR and determine if initial surveillance at 6-month CTA is appropriate. METHODS: A single-center retrospective chart review of all elective EVARs at a tertiary medical center over a 12-year period was conducted. Patients were excluded if postoperative surveillance imaging was not available. Data analysis encompassed demographics, chart review, and imaging including angiogram and cross-sectional imaging to asses for endoleaks and other findings. RESULTS: There were 363 patients who underwent elective EVAR and had available postoperative imaging during the study period. Within the 1-month follow-up, a CTA group of 316 patients was detected with 98 (31%) endoleaks. Of these, 5 (1.5%) required intervention: 1 for infolding of an iliac limb and 4 for type I endoleak which was present on completion angiogram-3 in patients treated outside of instructions for use and 1 with a type Ib endoleak on intraoperative completion imaging. In the 158 patients with 1 and 3-month CTAs, there were 47 persistent endoleaks, 9 previously undetected endoleaks not seen in 1-month CTA, and 13 resolved endoleaks. Three patients (1.2%) underwent intervention for type II endoleak and aneurysm expansion. In 47 patients with only a 6-month CTA, there were 16 endoleaks not seen on completion angiography and 2 of which were treated with reintervention-1 for a type I endoleak and 1 for a type II endoleak. CONCLUSIONS: There is limited utility to 1-month surveillance CTA in patients undergoing elective EVAR within the device instructions for use that has no evidence of type I endoleak on completion angiography. It is safe to start routine EVAR surveillance at 6 months in this patient population. This has implications when considering bundled and value-based payments in the longitudinal care of abdominal aortic aneurysm patients.


Subject(s)
Aortic Aneurysm, Abdominal/surgery , Aortography/methods , Blood Vessel Prosthesis Implantation , Computed Tomography Angiography , Endoleak/diagnostic imaging , Endovascular Procedures , Aged , Aged, 80 and over , Aortic Aneurysm, Abdominal/diagnostic imaging , Blood Vessel Prosthesis Implantation/adverse effects , Early Diagnosis , Endoleak/etiology , Endoleak/therapy , Endovascular Procedures/adverse effects , Female , Humans , Illinois , Male , Middle Aged , Predictive Value of Tests , Retrospective Studies , Time Factors , Treatment Outcome
15.
J Surg Res ; 233: 335-344, 2019 01.
Article in English | MEDLINE | ID: mdl-30502268

ABSTRACT

BACKGROUND: Current procedures to treat severe atherosclerosis are traumatic to the arterial wall and often result in restenosis due to neointimal hyperplasia. We developed a novel therapy using a specially designed double occlusion balloon catheter, ultrasonic wire, and enzymatic digestion solution to atraumatically debulk atherosclerotic plaques. MATERIALS AND METHODS: A combination of different enzymes, chemicals, and treatment conditions were evaluated for its effect at reducing atherosclerotic plaque harvested from human carotid artery endarterectomies ex vivo. The optimized digestion solution was examined in harvested intact human superficial femoral arteries in situ. A conventional Yorkshire/Landrace and a genetically modified Yucatan minipig homozygous for a nonfunctional LDLR mutation were used to evaluate the endovascular therapy in nonatherosclerotic and atherosclerotic environments in vivo. RESULTS: Ex vivo, the technology successfully digested human carotid artery plaques by 75%. In situ, the therapy successfully reduced plaque area in harvested superficial femoral arteries by 46%. In vivo, the endovascular therapy was technically feasible and demonstrated initial safety with no thrombosis, dissection, or aneurysmal dilatation in a nonatherosclerotic porcine model. In an atherosclerotic porcine model, the therapy demonstrated initial efficacy by successfully reducing atherosclerotic plaque while preserving the arterial wall with an intact internal elastic lamina. CONCLUSIONS: Using human plaque, human artery, and a normal and atherosclerotic pig model, we demonstrated that delivery of our therapy to the vasculature is technically feasible, appears safe, and shows initial efficacy. Our percutaneous plaque debulking method is a unique and promising therapy for the treatment of atherosclerosis and warrants further study.


Subject(s)
Angioplasty, Balloon/methods , Atherosclerosis/therapy , Hydrolases/administration & dosage , Plaque, Atherosclerotic/therapy , Ultrasonic Therapy/methods , Angioplasty, Balloon/instrumentation , Animals , Animals, Genetically Modified , Atherosclerosis/etiology , Atherosclerosis/pathology , Carotid Arteries/pathology , Diet, High-Fat/adverse effects , Disease Models, Animal , Feasibility Studies , Femoral Artery/pathology , Humans , Iliac Artery/pathology , Male , Plaque, Atherosclerotic/pathology , Receptors, LDL/genetics , Swine , Swine, Miniature , Treatment Outcome
16.
J Womens Health (Larchmt) ; 27(11): 1342-1348, 2018 11.
Article in English | MEDLINE | ID: mdl-30307789

ABSTRACT

INTRODUCTION: Prior studies have shown that sex bias exists with subject enrollment in clinical trials, with more men being enrolled than women. The objective of this study was to identify if sex bias continues to exist in present day clinical trials entered into ClinicalTrials.gov . We hypothesize that males and females are not equally represented in recent clinical trials. MATERIALS AND METHODS: Data were abstracted from all interventional Phase I, II, and III clinical trials with adult subjects entered into ClinicalTrials.gov from January 1, 2011 to December 31, 2013 and completed by November 30, 2015. Number and sex of subjects, funding source, allocation, end point classification, interventional model, and purpose were recorded. Studies pertaining to diseases that were sex specific were excluded. RESULTS: Of 1,668 studies included in the initial search, 167 were excluded due to sex-specific study topic. Of the remaining 1,501 studies, 177,656 (51.1%) male and 170,331 (49.0%) female subjects were included. There was a significant difference in the sex of the subjects included in Phase I (64.1% male/35.9% female), Phase II (48.4% male/51.6% female), and Phase III (51.0% male/49.1% female) clinical trials (p < 0.05). Similarly, there was a significant difference in the sex of the subjects included in industry (50.7% male/49.3% female), National Institutes of Health (NIH) (56.6% male/43.4% female), "Other US Federal" (62.5% male/37.5% female), and "Other" funded (53.4% male/46.6% female) clinical trials (p < 0.0001), as well as between randomized (50.5% male/49.6% female) and nonrandomized (54.8% male/45.2% female) clinical trials (p < 0.0001). Upon evaluating if the sex of the subjects included in the individual clinical trials was equally matched, we found that only 4.1% of clinical trials had 100% sex matching, 22.2% had 80% sex matching, and 56.5% had 50% sex matching. Using a liberal 50% sex-matching criteria, Phase III and II clinical trials matched the sex of the subjects more frequently compared to Phase I trials (60.8%, 57.8%, and 45.5%, respectively, p = 0.003). CONCLUSION: These data reveal that sex bias is present in current day clinical trials. Despite legislation requiring NIH-funded clinical trials to include women, NIH-funded trials were not better than industry-funded trials at matching the inclusion of both sexes.


Subject(s)
Clinical Trials as Topic , Patient Selection/ethics , Sexism , Adult , Clinical Trials as Topic/methods , Clinical Trials as Topic/organization & administration , Clinical Trials as Topic/standards , Female , Humans , Male , Research Design , Research Support as Topic/methods , Research Support as Topic/statistics & numerical data , Sexism/ethics , Sexism/prevention & control , Sexism/statistics & numerical data , United States
17.
J Vasc Surg ; 68(2): 607-610, 2018 08.
Article in English | MEDLINE | ID: mdl-30037677

ABSTRACT

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.


Subject(s)
Aorta/surgery , Blood Vessel Prosthesis Implantation/methods , Brachiocephalic Trunk/surgery , Peripheral Arterial Disease/surgery , Sternotomy/methods , Aged , Aorta/diagnostic imaging , Aorta/physiopathology , Brachiocephalic Trunk/diagnostic imaging , Brachiocephalic Trunk/physiopathology , Female , Humans , Middle Aged , Peripheral Arterial Disease/diagnostic imaging , Peripheral Arterial Disease/physiopathology , Retrospective Studies , Suture Techniques , Treatment Outcome
18.
JAMA Surg ; 153(7): 663-670, 2018 07 01.
Article in English | MEDLINE | ID: mdl-29590329

ABSTRACT

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.


Subject(s)
Authorship , Biomedical Research/statistics & numerical data , Publishing/statistics & numerical data , Sexism/statistics & numerical data , Specialties, Surgical , Bibliometrics , Female , Humans , Male , Sex Factors
19.
Ann Vasc Surg ; 48: 159-165, 2018 Apr.
Article in English | MEDLINE | ID: mdl-29217441

ABSTRACT

BACKGROUND: Historically, patients with chronic mesenteric ischemia (CMI) are underweight with a low body mass index (BMI). However, with the recent obesity epidemic many of these patients now are overweight with a high BMI. We evaluated the impact of BMI on outcomes after mesenteric revascularization for CMI. METHODS: A retrospective chart review of patients undergoing open or endovascular mesenteric revascularization for CMI between January 2000 and June 2015 was performed. Demographics, comorbidities, BMI, Society for Vascular Surgery-combined comorbidity score, treatment modality, postoperative complications, reintervention, and all-cause mortality were analyzed. The primary end point for the study was all-cause mortality at 5 years. Patients were stratified using the World Health Organization BMI criteria. Univariate, Kaplan-Meier survival, and multivariate analyses were performed. RESULTS: In the study period, 104 unique patients underwent mesenteric revascularization for CMI, for 77 of whom BMI information was available. Of these 77, 30 patients were treated by endovascular revascularization, and 47 patients were treated by open revascularization. Overall, 27 (35.1%) were overweight or obese with a BMI ≥25. Median follow-up time was 41 months. High BMI patients were less likely to have weight loss at the time of surgery (P = 0.004). Stratified by BMI <25 versus BMI ≥25, 5-year survival for patients treated by open revascularization was 90% versus 50% (P = 0.02); survival for patients treated by endovascular revascularization was 27% vs. 53% (P = 0.37). Multivariate survival analysis identified active smoking, hypertensive chronic kidney disease, open repair with the use of venous conduit instead of prosthetic conduit (P < 0.001), and history of peripheral arterial disease (PAD) (P = 0.002), as independent predictors of increased all-cause mortality. CONCLUSIONS: BMI needs to be considered in assessing and counseling patients on outcomes of mesenteric revascularization for CMI, as a BMI over 25 is associated with poorer long-term survival after open revascularization. Smoking, hypertensive chronic kidney disease, PAD, and open repair with the use of venous conduit are independent predictors of long-term mortality after mesenteric revascularization independent of BMI.


Subject(s)
Blood Vessel Prosthesis Implantation , Body Mass Index , Endovascular Procedures , Mesenteric Ischemia/surgery , Obesity/diagnosis , Veins/transplantation , Adult , Aged , Aged, 80 and over , Blood Vessel Prosthesis , Blood Vessel Prosthesis Implantation/adverse effects , Blood Vessel Prosthesis Implantation/instrumentation , Blood Vessel Prosthesis Implantation/mortality , Chronic Disease , Comorbidity , Endovascular Procedures/adverse effects , Endovascular Procedures/instrumentation , Endovascular Procedures/mortality , Female , Humans , Hypertension/mortality , Kaplan-Meier Estimate , Male , Mesenteric Ischemia/diagnosis , Mesenteric Ischemia/mortality , Middle Aged , Multivariate Analysis , Obesity/mortality , Peripheral Arterial Disease/mortality , Postoperative Complications/epidemiology , Proportional Hazards Models , Renal Insufficiency, Chronic/mortality , Retrospective Studies , Risk Factors , Smoking/adverse effects , Smoking/mortality , Time Factors , Treatment Outcome
20.
Am J Surg ; 215(2): 238-242, 2018 Feb.
Article in English | MEDLINE | ID: mdl-29179909

ABSTRACT

INTRODUCTION: Exposure to pain management curriculum in medical school is currently variable. This paper reports on formal prescribing education, self-perceived prescribing readiness, and prescribing practices among incoming surgical residents before and after a pain management training session. METHODS: Pre-residency survey of thirty surgical interns at a single urban medical center, followed by a repeat survey after an educational session on prescription writing and opioid abuse. RESULTS: Thirty-three percent of respondents had formal education on prescription writing in medical school. Median subjective preparedness to write an opioid prescription was 1.5 (range 1-10) on a 1-10 Likert scale. Ranges of morphine milligram equivalents (MME) prescribed varied from 420-2700 MME for 8 mock surgical scenarios. Post-training, median subjective preparedness increased to 3.5 (range 1-6) and prescription accuracy (the inclusion of a medication, dose, frequency, and duration) improved from 75% to 97% (p < 0.001). Overall, 90% of interns found the training session useful. CONCLUSION: Most surgical interns were not trained in prescribing narcotics in medical school. Improved pain management curriculum is necessary to assure safe and consistent opioid prescriptions.


Subject(s)
Analgesics, Opioid/therapeutic use , Clinical Competence , General Surgery/education , Internship and Residency/methods , Pain Management , Pain/drug therapy , Practice Patterns, Physicians' , Curriculum , Drug Prescriptions , Follow-Up Studies , Humans , Opioid-Related Disorders/prevention & control , Surveys and Questionnaires , United States
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