Research Spotlight

Baxter, R. D., S. K. Hansen, C. E. Gable, J. M. DiMaio, W. P. Shutze and D. R. Gable (2020). “Outcomes of Open versus Percutaneous Access for Patients Enrolled in the GREAT Registry.” Ann Vasc Surg Jun 27;S0890-5096(20)30534-3. [Epub ahead of print.].

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BACKGROUND: Arterial access and device delivery in endovascular aortic repair (EVAR) and thoracic endovascular aortic repair (TEVAR) have evolved from open femoral or iliac artery exposure to selective percutaneous arterial access. Although regional application of percutaneous access for these two procedures varies widely, the use of this technique continues to increase. [1,2] Currently, differences in the use of percutaneous access between EVAR and TEVAR have not been well explored. The Gore Global Registry for Endovascular Aortic Treatment (GREAT) registry collected relevant data for evaluation of these issues as well as the comparative results between open and percutaneous approaches in regards to complication rates and length of stay. METHODS: This study was performed via a retrospective review of patients from the GREAT registry (Clinicaltrials.gov no. NCT01658787). The primary variable of this study was access site complications including postoperative hematoma, vessel dissection, and pseudoaneurysm. Patients were categorized by abdominal (EVAR) and thoracic (TEVAR) aortic procedures using percutaneous-only, cutdown-only, and combined vascular access techniques for a total of 6 groups. Standard statistical methodology was used to perform single- and multi-variable analysis of a variety of covariates including length of stay (LOS), geographical location of procedure, procedural success rate and access sheath size. RESULTS: Of 4,781 patients from the GREAT registry, 3,837 (80.3%) underwent EVAR and 944 (19.7%) underwent TEVAR with percutaneous-only access techniques being used in 2,017 (42.2%) and cutdown-only in 2,446 (51.2%). There was variable application of percutaneous access by geographic region with Australia and New Zealand using this technique more frequently and Brazil using percutaneous access the least. No significant difference in the rate of access site complications were detected between the 6 groups of patients in the study; however, significantly lower rates of access site complications were associated with percutaneous-only compared with both cutdown-only and combined techniques (p=0.03). Also associated with significantly higher rates of access site complications was longer lengths of stay (p<0.01). Average LOS was 5.2 days and was higher in the TEVAR group (10.1 days) compared to EVAR (4.0 days, p<0.05). Increased sheath size does not appear to increase the risk of access site complication. CONCLUSIONS: There was no significant difference found in the complication rate between percutaneous and cutdown access techniques. This analysis demonstrates that percutaneous-only access is safe, has low complication rates, and has lower LOS compared to open access or combined access techniques.

Dawson, D. L. (2020). “Moving toward consensus for the best method to test for venous reflux in the vascular laboratory.” J Vasc Surg Venous Lymphat Disord 8(4): 501-502.

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The 2020 appropriate use criteria for chronic lower extremity venous disease, developed by the American Venous Forum (AVF), the Society for Vascular Surgery, the American Vein and Lymphatic Society, and the Society of Interventional Radiology and published in this issue of the Journal of Vascular Surgery: Venous and Lymphatic Disorders, will help to improve the care of patients with chronic venous disease. Dr Masuda and her collaborators are to be commended for their work. [ No abstract available; excerpt from Editorial.].

Nakase-Richardson, R., M. N. Dahdah, E. Almeida, P. Ricketti, M. A. Silva, K. Calero, U. Magalang and D. J. Schwartz (2020). “Concordance between current American Academy of Sleep Medicine and Centers for Medicare and Medicare scoring criteria for obstructive sleep apnea in hospitalized persons with traumatic brain injury: a VA TBI Model System study.” J Clin Sleep Med 16(6): 879-888.

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STUDY OBJECTIVES: The objective of this study was to compare obstructive sleep apnea (OSA), demographic, and traumatic brain injury (TBI) characteristics across the American Academy of Sleep Medicine (AASM) and Centers for Medicare and Medicare (CMS) scoring rules in moderate to severe TBI undergoing inpatient neurorehabilitation. METHODS: This is a secondary analysis from a prospective clinical trial of sleep apnea at 6 TBI Model System study sites (n = 248). Scoring was completed by a centralized center using both the AASM and CMS criteria for OSA. Hospitalization and injury characteristics were abstracted from the medical record, and demographics were obtained by interview by trained research assistants using TBI Model System standard procedures. RESULTS: OSA was prevalent using the AASM (66%) and CMS (41.5%) criteria with moderate to strong agreement (weighted κ = 0.64; 95% confidence interval = 0.58-0.70). Significant differences were observed for participants meeting AASM and CMS criteria (concordant group) compared with those meeting criteria for AASM but not CMS (discordant group). At an apnea-hypopnea index ≥ 5 events/h, the discordant group (n = 61) had lower Emergency Department Glasgow Coma Scale Scores consistent with greater injury severity (median, 5 vs 13; P = .0050), younger age (median, 38 vs 58; P < .0001), and lower body mass index (median, 22.1 vs 24.8; P = .0007) compared with the concordant group (n = 103). At an apnea-hypopnea index ≥ 15 events/h, female sex but no other differences were noted, possibly because of the smaller sample size. CONCLUSIONS: The underestimation of sleep apnea using CMS criteria is consistent with prior literature; however, this is the first study to report the impact of the criteria in persons with moderate to severe TBI during a critical stage of neural recovery. Management of comorbidities in TBI has become an increasing focus for optimizing TBI outcomes. Given the chronic morbidity after moderate to severe TBI, the impact of CMS policy for OSA diagnosis for persons with chronic disability and young age are considerable.

Cowey, C. L., N. J. Robert, J. L. Espirito, K. Davies, J. Frytak, I. Lowy and M. G. Fury (2020). “Clinical outcomes among unresectable, locally advanced, and metastatic cutaneous squamous cell carcinoma patients treated with systemic therapy.” Cancer Med Jun 24. [Epub ahead of print.].

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Prior studies of conventional chemotherapy or epidermal growth factor receptor inhibitors for advanced (ie, locally advanced cutaneous squamous cell carcinoma [laCSCC] or metastatic [mCSCC]) cutaneous squamous cell cancer enrolled ≤ 40 patients. This retrospective, observational study assessed real-world treatment patterns and clinical outcomes in patients with unresectable laCSCC or mCSCC using electronic health records of patients who initiated first-line (1L) systemic treatment from 1 January 2008 to 31 December 2015, with follow-up to 30 September 2017. The median duration of follow-up from 1L treatment was 10.1 months (range 0.03-67.6 months). Duration of therapy (DOT) and overall survival (OS) were assessed using Kaplan-Meier analysis. Response rate was calculated as the proportion of patients who achieved physician-assessed-response. Eighty-two patients were identified (17 laCSCC and 65 mCSCC). Median age at 1L treatment initiation was 75 years; 85% were male, 88% had an Eastern Cooperative Oncology Group performance status of 1, and 84% had received radiotherapy. The most common 1L regimens were carboplatin + paclitaxel (27%) and cetuximab monotherapy (24%). The median 1L DOT was 4.1 months for laCSCC and 2.3 months for mCSCC. The physician-assessed response rate for 1L therapy was 17.6% for laCSCC, and 18.5% for mCSCC. The median OS from 1L treatment initiation was 16.2 months for laCSCC, and 15.3 months for mCSCC. Only 24 patients (29%) received second-line therapy. This is the largest retrospective data set regarding patients with advanced CSCC treated with anticancer systemic therapy prior to approval of the anti-programmed cell death-1 antibody, cemiplimab. Efficacy was low in both laCSCC and mCSCC. These data provide historic benchmarks for outcomes in patients with advanced CSCC prior to Food and Drug Administration approval of cemiplimab-rwlc.

Pei-Chuan Huang, E., C. M. Fu, W. T. Chang, C. H. Huang, M. S. Tsai, E. Chou, J. Wolfshohl, C. H. Wang, Y. W. Wu and W. J. Chen (2020). “Associations of thoracic cage size and configuration with outcomes of adult in-hospital cardiac arrest: A retrospective cohort study.” J Formos Med Assoc Jun 11;S0929-6646(20)30231-X. [Epub ahead of print.].

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BACKGROUND: To analyse the association of thoracic cage size and configuration with outcomes following in-hospital cardiac arrest (IHCA). METHODS: A single-centred retrospective study was conducted. Adult patients experiencing IHCA during 2006-2015 were screened. By analysing computed tomography images, we measured thoracic anterior-posterior and transverse diameters, circumference, and both anterior and posterior subcutaneous adipose tissue (SAT) depths at the level of the internipple line (INL). We also recorded the anatomical structure located immediately posterior to the sternum at the INL. RESULTS: A total of 649 patients were included. The median thoracic circumference was 88.6 cm. The median anterior and posterior thoracic SAT depths were 0.9 and 1.5 cm, respectively. The ascending aorta was found to be the most common retrosternal structure (57.6%) at the INL. Multivariate logistic regression analyses indicated that anterior thoracic SAT depth of 0.8-1.6 cm (odds ratio [OR]: 2.98, 95% confidence interval [CI]: 1.40-6.35; p-value = 0.005) and thoracic circumference of 83.9-95.0 cm (OR: 2.48, 95% CI: 1.16-5.29; p-value = 0.02) were positively associated with a favourable neurological outcome while left ventricular outflow track or aortic root beneath sternum at the level of INL was inversely associated with a favourable neurological outcome (OR: 0.37, 95% CI: 0.15-0.91; p-value = 0.03). CONCLUSION: Thoracic circumference and anatomic configuration might be associated with IHCA outcomes. This proof-of-concept study suggested that a one-size-fits-all resuscitation technique might not be suitable. Further investigation is needed to investigate the method of providing personalized resuscitation tailored to patient needs.