VIEW-VLU observational study of the effect of Varithena on wound healing in the treatment of venous leg ulcers.

OBJECTIVE: Chronic venous hypertension, triggered by venous reflux and/or obstruction, leads to skin changes and venous leg ulcers (VLUs). Compression therapy is the standard of care, but many wounds remain unhealed. The objectives of this study were to observe the effects of endovenous chemical ablation with commercially available 1% polidocanol injectable microfoam on VLU healing and recurrence rates. METHODS: The VIEW VLU study was a multicenter, open-label, phase IV registry of patients with active VLUs resulting from venous insufficiency of the great saphenous vein and/or anterior accessory saphenous vein systems who underwent ablation with 1% polidocanol microfoam. Primary outcomes included wound healing rate (change in wound perimeter), wound closure at 12 weeks after treatment, and time to wound closure. Secondary outcomes included VLU recurrence, numeric pain score at the ulcer location, EuroQol five-dimension five-level questionnaire quality-of-life index, and the Venous Clinical Severity Score. Patients were followed for 12 months. RESULTS: We enrolled 76 patients (80 ulcers) from 14 sites across the United States and Canada (mean age 63.6 ± 13.7 years, 39.5% female, mean body mass index 36.3). Of the enrollees, 96.3% presented with great saphenous vein incompetence. The mean baseline wound perimeter was 117.2 ± 107.4 mm and 26.3% of wounds (21/80) were circumferential. The mean ulcer age was 34.8 ± 51.8 weeks at first presentation and the mean compression therapy duration was 26.4 ± 35.9 weeks. The median wound perimeter decreased by 16.3% from baseline in the first 2 weeks after the procedure and by 27.0% at 12 weeks. By 12 weeks, 53.8% of wounds (43/80) were healed. The median time to ulcer closure by Kaplan-Meier analysis was 89 days (95% confidence interval, 62.0-117.0). In a Kaplan-Meier analysis of initially healed wounds, 88.9% (95% confidence interval, 76.9-94.8) remained closed at 12 weeks after closure. The mean numeric pain scores (ulcer site) improved by 41.0% and 64.1% at 12 weeks and 12 months after the procedure, respectively. The health-related quality-of-life index (scale of 0-1) improved from 0.65 ± 0.27 at baseline to 0.72 ± 0.28 at 12 weeks and 0.73 ± 0.30 at 12 months. By 12 weeks after treatment, the mean target leg Venous Clinical Severity Score had significantly decreased by 5.8 points, and by 12 months it had decreased by 10.0 points. CONCLUSIONS: Treatment with 1% polidocanol microfoam was associated with promising wound healing rates and low recurrence rates for VLUs, despite a challenging patient population with recalcitrant ulcers, a large percentage of which were circumferential, in patients with high body mass indexes.

The myth of informed consent in rectal cancer surgery: what do patients retain?

BACKGROUND: Previous research in colorectal cancer has focused on survival, recurrence, and functional outcomes. Few have assessed the decisional needs of patients or the information patients are retaining from the informed consent process. OBJECTIVES: The aims of this study were to describe the decisional needs of adult patients with rectal cancer when deciding on the surgical treatment of their disease and to identify gaps in patients' recollection of the informed consent discussion. DESIGN: Face-to-face interviews were conducted with the use of a questionnaire based on the validated Ottawa Decision Support Framework Needs Assessment. SETTING: This study was performed at a university-based academic Cancer Assessment Center, in Ottawa, Ontario, Canada. PATIENTS: Adult patients with rectal cancer treated with low anterior resection or abdominoperineal resection were included. MAIN OUTCOME MEASURES: The primary outcomes measured were patients' knowledge and understanding of decision and their decisional needs. RESULTS: Thirty patients were interviewed between November 2009 and July 2010. Eighty percent were male, with a median age of 65. None of the patients perceived having a choice of surgical options. When questioned about the main outcomes of rectal cancer surgery, 47% could not recall a preoperative discussion of risks to bowel function, 47% could not recall a preoperative discussion of risks to sexual function, and 57% could not recall a preoperative discussion of risks to urinary function. Patients would like information regarding functional outcomes, body image, and the immediate postoperative period. A minority of patients desire information regarding cure rate, need for a second surgery, or the ability of surgery to treat their symptoms. Patients would like information that is portable and trusted by their health care team that they can review at their own time. LIMITATIONS: To avoid introducing decisional conflict before surgery, patients were interviewed at the first postoperative visit. Preoperative informed consent discussions were not standardized. CONCLUSION: Despite a comprehensive educational oncology pathway, patients retain little of the informed consent discussion. This study highlights the dichotomy between the outcomes that surgeons and patients value most. The results of this study will guide future efforts to improve informed consent.

Evaluating the relationship between right-to-left shunt and white matter hyperintensities in migraine patients: A systematic review and meta-analysis.

Introduction: White matter hyperintensities (WMHs) have been observed with greater frequency in patients with migraine and are thought to be associated with impaired cognition and function. The relationship between WMHs and right-to-left shunt (RLS) in migraine patients is unknown. We performed a systematic review to determine if there is an association between RLS and WMHs in patients with migraine. Methods: A systematic search of the literature was performed in PubMed and Embase using a suitable keyword search strategy from inception up to 16th June 2021. All studies that included patients with migraine and studied RLS and WMHs were included. Results: A total of 8 non-randomized observational studies comprising 1125 patients with migraine were included; 576 had an RLS, compared to 549 patients with no RLS. The mean age of the study populations ranged from 28.4 to 43 years, while the average duration from migraine diagnosis ranged from 5.1 to 19 years. The proportion of female to male patients was consistently higher in all studies (60.0-94.4%). Amongst migraine patients with RLS, 338 patients (58.7%) had WMHs. In contrast, 256 (46.6%) of migraine patients without RLS had WMHs. RLS was significantly associated with the presence of WMHs in migraine patients (OR: 1.56, 95% CI: 1.05-2.34, p = 0.03). Conclusion: In migraine patients, RLS was significantly associated with the presence of WMHs. Longitudinal studies are warranted to establish RLS as a risk factor for WMHs in patients with migraine, and to establish the significance of these changes.