AbsorbaSeal™ Vascular Closure Device: A Novel Device for Hemostasis Following Interventional Peripheral Vascular Procedures.

INTRODUCTION: Vascular closure devices (VCDs) are designed to achieve rapid hemostasis during percutaneous coronary and peripheral vascular procedures. Studies demonstrate that VCDs improve time to hemostasis (TTH) and time to ambulation (TTA) in comparison to standard manual compression. The available products, however, typically have 13-17 steps in their application, often require hemostatic collagen or other agents as part of the process, and can result in significant scarring at the puncture site that can impact future access. The aim of this study was to investigate the performance of a three-step, novel VCD for access site TTH, short-term and long-term histology, and a first-in-man clinical study. MATERIALS AND METHODS: This study evaluated AbsorbaSeal™ (CyndRx, LLC, Brentwood, Tennessee), a simple, three-step, VCD with bio-absorbable components. Following an institutional review board (IRB) approval, a 6-F sheath was placed directly into the porcine aorta, AbsorbaSeal™ was used to seal the puncture site, and a measure of total time of deployment (TTD) and TTH was performed, as well as histologic evaluation at 30, 60, and 180 days. A complement activation test was performed to determine the potential for activation of the complement system as a mediator of inflammation. The test was performed by directly incubating the VCDs AbsorbaSeal™ and Angio-Seal™ (Terumo Interventional Systems, Tokyo, Japan) in human serum. Serum samples were removed after 30, 60, and 90 minutes and tested for the presence and amount of complement protein SC5b-9. In the first in-man trial, the device was deployed in anticoagulated patients undergoing interventional vascular procedures. The TTH, estimated blood loss, patient pain scores, and procedural and follow-up complications were recorded. RESULTS: In the acute and chronic porcine studies, TTD averaged 25 seconds (17-29 seconds). Vascular control was immediate, yielding a TTH of effectively zero seconds. Histologic evaluation demonstrated complete endothelial coverage of the device by 30 days without evidence of bleeding, clotting, or inflammation. At 60 days, the significant mass of the device had dissolved and normal appearing collagen surrounded the devices with essentially no inflammatory response. By six months, all but one microscopic segment of one of the devices had been absorbed with normal appearing vascular endothelium, and no, or minimal, scarring appreciated. The complement test demonstrated that the AbsorbaSeal™ had similar, or lower, complement concentrations than the negative controls and significantly less than Angio-Seal™. This supported the histologic findings of minimal to no inflammation. The VCD was deployed in 20 patients undergoing interventional vascular procedures. The mean TTH was 2.3 ± 1.5 minutes. Estimated blood loss was 11.7 mL ± 3.5 mL, and no significant hematoma was noted. Post-procedure pain scores were low, with a mean of 1.4 ± 0.8 on a 0-10 pain rating scale. There were no perioperative complications and no adverse events at follow-up. CONCLUSIONS: The AbsorbaSeal™ is safe and simple to use for vascular closure after interventional vascular procedures with favorable outcomes including a short TTH, minimal procedural blood loss, low postoperative pain scores, and no perioperative complications or adverse effects. Histologic evaluation reveals rapid device absorption and little scar formation both short- and long-term. A direct study of complement activation supports that AbsorbaSeal™ evokes a minimal inflammatory response that is significantly less than Angioseal.

Reporting of mitotic rate in cutaneous melanoma: A study using the national cancer data base.

BACKGROUND: The seventh edition of the American Joint Commission on Cancer staging manual (AJCC7, published 2009), updated thin cutaneous melanoma staging protocols with the incorporation of mitotic rate (MR). In these patients, higher MR is associated with decreased survival. This study utilizes the National Cancer Data Base (NCDB) to evaluate MR reporting since AJCC7. METHODS: The NCDB was queried for patients with primary cutaneous melanoma from 1998 to 2013. Because MR reporting was infrequent prior to implementing AJCC7, records from 2010 to 2013 were analyzed. Categorical variables were compared with chi-square tests; univariate and multivariate logistic regression models were constructed to determine the effects of covariates on MR reporting. RESULTS: A total of 107,134 patients met inclusion criteria. From 2010 to 2013, MR reporting increased dramatically (64.3-80.9%). On multivariate analysis, factors significantly related to increased MR reporting include later diagnosis year, T-classification (T1a and b vs. T1), facility type (academic vs. other specified types of cancer programs), facility volume, patient income, level of education, and county population (metropolitan vs. urban and rural). CONCLUSIONS: MR reporting increased dramatically after the introduction of AJCC7; however, disparities in reporting remain across facility types. Further investigation of procedures performed in academic settings that may influence reporting of MR is warranted. J. Surg. Oncol. 2017;115:281-286. © 2017 Wiley Periodicals, Inc.

Injuries from all-terrain vehicles: An opportunity for injury prevention.

BACKGROUND: Patient demographics, behavior, and injury patterns were assessed to inform preventative efforts for reduced incidence of all-terrain vehicle (ATV) trauma. METHODS: ATV-related injuries treated at a Level I trauma center from 2008 to 2012 were retrospectively reviewed. Patient outcomes and incidence of traumatic brain injury (TBI) were compared by helmet use and alcohol intoxication. RESULTS: Helmet data were available for 304 patients of 404 patients included; of these, 75 (24.7%) wore a helmet. Incidence of TBI was lower in the helmeted (8.0%) versus the unhelmeted subgroup (26.6%) (P < 0.001). Helmeted patients had lower injury severity scores, lower intensive-care unit (ICU) admission rates, and shorter ICU and hospital length of stay (LOS) (P < 0.05). Intoxicated patients had higher rates of TBI and ICU admission as well as prolonged ICU LOS (P < 0.05). CONCLUSIONS: These data support the requirement for a greater emphasis on injury prevention among ATV users.

What is the value of the SAGES/AORN MIS checklist? A multi-institutional practical assessment.

BACKGROUND: Surgical safety checklists reduce perioperative complications and mortality. Given that minimally invasive surgery (MIS) is dependent on technology and vulnerable to equipment failure, SAGES and AORN partnered to create a MIS checklist to optimize case flow and minimize errors. The aim of this project was to evaluate the effectiveness of the SAGES/AORN checklist in preventing disruptions and determine its ease of use. METHODS: The checklist was implemented across four institutions and completed by the operating team. To assess its effectiveness, we recorded how often the checklist identified problems and how frequently each of the 45 checklist items were not completed. The perceived usefulness, ease of use, and frustration associated with checklist use were rated on a 5-point Likert scale by the surgeon. We assessed any differences dependent on timing of checklist completion and among institutions. RESULTS: The checklist was performed during MIS procedures (n = 114). When used before the procedure (n = 36), the checklist identified missing items in 13 cases (36.11 %). When used after the procedure (n = 61), the checklist identified missing items in 18 cases (29.51 %) that caused a delay of 4.1 ± 11.1 min. The most frequently missed items included preference card review (14.0 %), readiness of the carbon dioxide insufflator (8.7 %), and availability of the Veress needle (3.6 %). The checklist took an average of 3.6 ± 2.7 min to complete with its usefulness rated 2.6 ± 1.5, ease of use 2.0 ± 1.2, and frustration 1.3 ± 1.1. CONCLUSION: The checklist identified problems in 24 % of cases that led to preventable delays. The checklist was easy to complete and not frustrating, indicating it could improve operative flow. This study also identified the most useful items which may help abbreviate the checklist, minimizing the frustration and time taken to complete it while maximizing its utility. These attributes of the SAGES/AORN MIS checklist should be explored in future larger-scale studies.

Traumatic liver injuries in the elderly as compared to younger adults.

BACKGROUND: Comparing elderly (> 55 years) and younger (< 55 and > 15 years) traumatic liver injury patients, we evaluated differences in the need for operative intervention as well as transfusion requirements in those treated non-operatively. METHODS: This was a retrospective cohort study of adult patients with liver trauma. The analyses evaluated overall adjusted differences in treatment option and packed red blood utilization in those treated non-operatively by age group. RESULTS: 841 patients were included. 83 were elderly. Operative management occurred in 13% and 12% of the younger adults and elderly patients, respectively. After adjustment, age group was not significantly associated with treatment option. In the non-operative setting, elderly patients had twice the red blood cell transfusion requirement as compared to younger adults. CONCLUSIONS: Age does not play a role in considering the need for surgical intervention in patients with liver trauma. However, the geriatric population has twice the transfusion requirement in the non-operative setting.