Selective Publication within Vascular Surgery: Characteristics of Discontinued and Unpublished Randomized Clinical Trials.

BACKGROUND: Discontinued and unpublished randomized clinical trials (RCTs) are common resulting in biased publication and loss of potential knowledge. The magnitude of selective publication within vascular surgery remains unknown. METHODS: RCT relevant to vascular surgery registered (01/01/2010-10/31/2019) on ClinicalTrials.gov were included. Trials ending normally with conclusion of participant treatment and examination were considered completed whereas discontinued trials stopped early. Publications were identified through automatically indexed PubMed citations on ClinicalTrials.gov or manually identified on PubMed or Google Scholar >30 months after the completion date, the date the final participant was examined, allowing time for publication. RESULTS: Of 108 RCT (n = 37, 837), 22.2% (24/108) were discontinued, including 16.7% (4/24) stopped prior to and 83.3% (20/24) after starting enrollment. Only 28.4% of estimated enrollment was achieved for all discontinued RCT. Nineteen (79.2%) investigators provided a reason for discontinuation, which most commonly included poor enrollment (45.8%), inadequate supplies or funding (12.5%), and trial design concerns (8.3%). Of the 20 trials terminated following enrollment, 20.0% (4/20) were published in peer-reviewed journals and 80.0% (16/20) failed to reach publication. Of the 77.8% trials completed, 75.0% (63/84) were published and 25.0% (21/84) remain unpublished. In a multivariate regression of completed trials, industry funding was significantly associated with decreased likelihood of peer-reviewed publication (OR = 0.18, (95% CI 0.05-0.71), P = 0.01). Of the discontinued and completed trials remaining unpublished, 62.5% and 61.9% failed to report results on ClinicalTrials.gov, respectively, encompassing a total of 4,788 enrollees without publicly available results. CONCLUSIONS: Nearly 25% of registered vascular RCT were discontinued. Of completed RCT, 25% remain unpublished with industry funding associated with decreased likelihood of publication. This study identifies opportunities to report all findings for completed and discontinued vascular surgery RCT, whether industry sponsored, or investigator initiated.

Hospital-based delays to revascularization increase risk of postoperative mortality and short bowel syndrome in acute mesenteric ischemia.

OBJECTIVE: Acute mesenteric ischemia (AMI) is a surgical emergency for which delays in treatment have been closely associated with high morbidity and mortality. Although the duration of ischemia as a determinant of outcomes for AMI is well known, the objective of this study was to identify hospital-based determinants of delayed revascularization and their effects on postoperative morbidity and mortality in AMI. METHODS: All patients who underwent any surgery for AMI from a multi-center hospital system between 2010 and 2020 were divided into two groups based on timeliness of mesenteric revascularization after presentation. Early revascularization (ER) was defined as having both vascular consultation ≤12 hours of presentation and vascular surgery performed at the patient's initial operation. Delayed revascularization (DR) was defined as having either delays to vascular consultation or vascular surgery. A retrospective review of demographic and postoperative data was performed. The effect of DR on major postoperative outcomes, including 30-day and 2-year mortality, total length of bowel resection, and development of short bowel syndrome, were analyzed. Effects of delayed vascular consultation alone, delayed vascular surgery alone, no revascularization during admission, and admitting service on outcomes were also examined on subgroup analyses. RESULTS: A total of 212 patients were analyzed. Ninety-nine patients received ER, whereas the remaining 113 patients experienced a DR after hospital presentation. Among the DR group, 55 patients (25.9%) had delayed vascular consultation, whereas vascular surgery was deferred until after the initial operation in 37 patients (17.4%). Fifty-one patients (24.0%) were never revascularized during admission. DR was a significant predictor of 30-day (odds ratio [OR], 2.09; 95% confidence interval [CI], 1.4-4.9; P = .03) and 2-year mortality (hazard ratio, 1.55, 95% CI, 1.0-2.3; P = .04). DR was also independently associated with increased bowel resection length (OR, 7.47; P < .01) and postoperative short bowel syndrome (OR, 2.4; P = .03) on multivariate analyses. When examined separately on subgroup analysis, both delayed vascular consultation (OR, 3.38; P = .03) and vascular surgery (OR, 4.31; P < .01) independently increased risk of 30-day mortality. Hospital discharge after AMI without mesenteric revascularization was associated with increased risk of short bowel syndrome (OR, 2.94; P < .01) and late mortality (hazard ratio, 1.60; P = .04). CONCLUSIONS: Delayed vascular consultation and vascular surgery are both significant hospital-based determinants of postoperative mortality and short bowel syndrome in patients with AMI. Timing-based management protocols that emphasize routine evaluation by a vascular surgeon and early, definitive mesenteric revascularization should be established and widely adopted for all patients with clinically suspected AMI at presentation.

Contemporary management of acute and chronic mesenteric ischemia: 10-year experience from a multihospital healthcare system.

OBJECTIVE: Endovascular and hybrid methods have been increasingly used to treat mesenteric ischemia. However, the long-term outcomes and risk of symptom recurrence remain unknown. The objective of the present study was to define the predictors of postoperative morbidity, mortality, and patency loss for acute mesenteric ischemia (AMI) and chronic mesenteric ischemia (CMI). METHODS: The inpatient and follow-up records for all patients who had undergone revascularization for AMI and CMI from 2010 to 2020 at a multicenter hospital system were reviewed. Patency and mortality were evaluated with Cox regression, visualized with Kaplan-Meier curves, and compared using log-rank testing. Patency was further evaluated using Fine-Gray regression with death as a competing risk. The postoperative major adverse events (MAE) and 30-day mortality were evaluated with logistic regression. RESULTS: A total of 407 patients were included, 148 with AMI and 259 with CMI. For the AMI group, the 30-day mortality was 31%. Open surgery was associated with lower rates of bowel resection (odds ratio [OR], 0.23; 95% confidence interval [CI], 0.13-0.61). The etiology of AMI also did not change the outcomes (OR, 1.30; 95% CI, 0.77-2.19). Adjusted analyses indicated that a history of diabetes (OR, 2.77; 95% CI, 1.37-5.61) and sepsis on presentation (OR, 2.32; 95% CI, 1.18-4.58) were independently associated with an increased risk of 30-day MAE. In the CMI group, open surgery and chronic kidney disease were associated with a higher incidence of MAE (OR, 3.03; 95% CI, 1.14-8.05; OR, 2.37; 95% CI, 1.31-4.31). In contrast, chronic kidney disease (OR, 3.02; 95% CI, 1.10-8.37) and inpatient status before revascularization (OR, 2.78; 95% CI, 1.01-7.61) were associated with increased 30-day mortality. For the CMI group, the endovascular cohort had experienced greater rates of symptom recurrence (29% vs 13%) with a faster onset (endovascular, 64 days; vs bypass, 338 days). CONCLUSIONS: AMI remains a morbid disease despite the evolving revascularization techniques. An open approach should remain the reference standard because it reduces the likelihood of bowel resection. For CMI, endovascular interventions have improved the postoperative morbidity but have also resulted in early symptom recurrence and reintervention. An endovascular-first approach should be the standard of care for CMI with close surveillance.

Retrograde open mesenteric stenting should be considered as the initial approach to acute mesenteric ischemia.

OBJECTIVE: Retrograde open mesenteric stenting (ROMS) is an alternative to traditional bypass in patients who present with acute mesenteric ischemia (AMI). However, there is a paucity of data comparing outcomes of ROMS with other open surgical approaches. This study represents the largest single-institution experience with ROMS and aims to compare outcomes of ROMS with those of conventional mesenteric bypass. METHODS: All patients who presented with AMI from 2008 to 2019 and who were treated with either ROMS or mesenteric bypass were included in the study. Patient, procedure, and outcome variables were compared. Bypass and ROMS patients were compared using univariate statistics. RESULTS: A total of 34 patients who presented with AMI needing bypass were included in the study; 16 underwent mesenteric bypass, and 18 underwent ROMS. ROMS patients tended to be older than bypass patients and had higher rates of comorbidities. Bypass patients were more likely to have a history of chronic mesenteric symptoms (68.8% vs 27.8%; P = .019). Bypass procedures also took longer than ROMS procedures (302 vs 189 minutes; P < .01). The majority of ROMS procedures were not performed in a hybrid room (77.8%). Within 1 year, one stent thrombosed in a ROMS patient, requiring later mesenteric bypass. In the bypass group, one conduit thrombosed, ultimately resulting in perioperative death, and one bypass anastomosis stenosed, requiring angioplasty. Complication, unanticipated reintervention, and mortality rates were otherwise similar between groups. CONCLUSIONS: Complication, reintervention, and mortality rates after ROMS are similar to those of mesenteric bypass in the setting of AMI. Given similar postoperative outcomes and ability to perform these procedures in a conventional operating room but with significantly shorter operative times, ROMS should be considered a first-line option in acute situations when the operator is comfortable performing the procedure.

Acute superior mesenteric venous thrombosis results in high rates of readmission and morbidity.

OBJECTIVE: Superior mesenteric venous thrombosis (MVT) is a poorly understood clinical entity, and as such, outcomes are poorly described. This study aimed to identify predictors of bowel ischemia after MVT and to compare outcomes for patients treated medically (group 1) with those for patients treated with bowel resection (group 2). METHODS: This was a retrospective, single-institution study capturing all patients diagnosed with symptomatic acute MVT on computed tomography imaging from 2008 to 2018. Demographics, comorbidities, imaging, laboratory values, and treatment were included. Predictors of bowel resection were analyzed by univariate and multivariate statistics. Outcomes including mortality, readmissions for abdominal pain, and chronic mesenteric venous congestion were compared using χ2 test. RESULTS: There were 121 patients included in the study; 98 patients were treated medically (group 1), 19 patients were treated with bowel resection (group 2), and 4 patients were treated with endovascular recanalization (group 3). Group 1 and group 2 were compared directly. Patients requiring bowel resection tended to have higher body mass index (P = .051) and a hypercoagulable disorder (P = .003). Patients who required bowel resection were more likely to present with lactic acidosis (P < .001) and leukocytosis (P < .001) with bowel wall thickening on scan (P < .001). On multivariable analysis, a genetic thrombophilia was a strong predictor of bowel ischemia (odds ratio, 3.81; 95% confidence interval, 1.12-12.37). One-year mortality and readmission rates did not differ between groups. However, readmission rates for abdominal pain were high for both groups (group 1, 44.90%; group 2, 57.89%; P = .317), and a significant proportion of patients exhibited chronic mesenteric venous congestion on repeated scan (group 1, 42.86%; group 2, 47.37%; P = .104). CONCLUSIONS: A genetic hypercoagulable disorder is a predictor of bowel ischemia due to MVT. Regardless of treatment, outcomes after MVT are morbid, with high rates of readmission for abdominal pain. An alternative approach to treat these patients is needed, given the poor outcomes with current strategies.

Lemierre's Syndrome: An Atypical Presentation.

Septic thrombophlebitis is a rare diagnosis in this era of widespread antibiotic usage. The clinical diagnosis requires astute clinical suspicion and evaluation. We describe an asplenic 63-year-old woman who presented to the emergency department with a 24-hour history of a tender, swollen, right neck and upper chest wall. She denied any recent illnesses, but two years before, she was hospitalized and treated for Streptococcus pneumoniae meningitis and endocarditis. An enhanced computed tomography scan demonstrated inflammatory changes around a thrombosed right internal jugular vein, which extended to the brachiocephalic/superior vena cava junction. A retropharyngeal effusion was present, but no pulmonary or oropharyngeal abscess was identified. Lemierre's syndrome, although rare, must be recognized promptly to reduce morbidity and mortality associated with this condition.

Acute Bilateral Lower Extremity Paralysis Secondary to Acute Thrombosis of an Infrarenal Abdominal Aortic Aneurysm.

We present the case of a 64-year-old male who presented to the emergency department with bilateral limb ischemia and paralysis for approximately 1 hour. Computed tomographic angiography demonstrated occlusion of the infrarenal aorta beginning just above the patient's known abdominal aortic aneurysm (AAA) and extending into both common iliac arteries. He was emergently treated via open repair of the AAA with a Gore-Tex tube graft, bilateral common iliac thrombectomies, and bilateral lower extremity four-compartment fasciotomies. Post-operatively, he had monophasic signals in both posterior tibial arteries, neither of which was present before the operation. During recovery, he developed an ileus but otherwise did not have complications. He was discharged to rehabilitation on post-operative day 15.