Browsing by Subject "hemostasis"

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    Hemostatic efficacy of an advanced bipolar sealer in open gynecologic, thoracic, and colectomy procedures: A prospective cohort study
    (Elsevier, 2020) Schilder, Jeanne; Anderson, David; Shah, Fatima; Holcomb, Bryan; Shah, Ahmar; Fullarton, Grant; Ashraf, Shazad; Fegan, Scott; Paterson, Hugh; Schwiers, Michael L.; Singleton, David W.; Waggoner, Jason R.; Fryrear, Raymond, II; Robb, Bruce W.; Surgery, School of Medicine
    Background An advanced bipolar (ABP) tissue sealer designed for division of major vessels in open procedures was evaluated in a prospective post-market study. The objective was to provide clinical data for assessment of vessel transection, hemostatic performance and ease of use of the ABP device during open colectomy, gynecologic, and thoracic operations. Materials and methods The ABP test device was used in colectomy (n = 36), gynecologic (n = 44), and thoracic (n = 21) procedure groups. Vessels transected with the ABP device were graded intraoperatively on a hemostasis scale of 1–4, defined as follows: Grade1, no bleeding; Grade 2, minor bleeding with no intervention; Grade 3, minor bleeding requiring touchup with the test device or monopolar cautery; and Grade 4, significant bleeding requiring intervention with any additional hemostatic product. The primary performance measure was the percentage of vessels that achieved hemostasis grades ≤3. The primary safety endpoint was the summarization of all ABP device-related adverse events (AEs). Results For all three procedure groups together, 302 (96.2%) of 314 total vessel transections were scored as hemostasis grades ≤ 3, including 270 (86.0%) that were rated Grade 1. Twelve transections (3.8%) were Grade 4, which included 9 vessels transected in the gynecologic group and 3 in the thoracic group. Three subjects experienced a total of 4 device-related AEs, consisting of hematoma, hypotension, procedural pain, and superficial thermal burn. All 4 device-related AEs were mild in severity. Conclusion The advanced bipolar device exhibited effective hemostasis, an acceptable safety profile, and ease of use during colectomy, thoracic, and gynecologic procedures.
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    Laboratory misdiagnosis of von Willebrand disease in post-menarchal females: A multi-center study
    (Wiley, 2020-09) Jaffray, Julie; Staber, Janice M.; Malvar, Jemily; Sidonio, Robert; Haley, Kristina M.; Stillings, Amy; Weyand, Angela; Hege, Kerry; Jain, Shilpa; Gupta, Sweta; Agnew, Caroline; Wheeler, Allison; Pawar, Anjali; Sharma, Mukta; Chitlur, Meera; O'Brien, Sarah H.; Kouides, Peter; Pediatrics, School of Medicine
    Increased awareness of von Willebrand Disease (VWD) has led to more frequent diagnostic laboratory testing, which insurers often dictate be performed at a facility with off-site laboratory processing, instead of a coagulation facility with onsite processing. Off-site processing is more prone to preanalytical variables causing falsely low levels of von Willebrand Factor (VWF) due to the additional transport required. Our aim was to determine the percentage of discordance between off-site and onsite specimen processing for VWD in this multicenter, retrospective study. We enrolled females aged 12 to 50 years who had off-site specimen processing for VWF assays, and repeat testing performed at a consulting institution with onsite coagulation phlebotomy and processing. A total of 263 females from 17 institutions were included in the analysis. There were 251 subjects with both off-site and onsite VWF antigen (VWF:Ag) processing with 96 (38%) being low off-site and 56 (22%) low onsite; 223 subjects had VWF ristocetin co-factor (VWF:RCo), 122 (55%) were low off-site and 71 (32%) were low onsite. Similarly, 229 subjects had a Factor VIII (FVIII) assay, and 67 (29%) were low off-site with less than half, 29 (13%) confirmed low with onsite processing. Higher proportions of patients demonstrated low VWF:Ag, VWF:RCo, and/or FVIII with off-site processing compared to onsite (McNemarʼs test P-value <.0005, for all assays). These results emphasize the need to decrease delays from sample procurement to processing for VWF assays. The VWF assays should ideally be collected and processed at the same site under the guidance of a hematologist.