Significant reduction in systolic blood pressure following renal artery stenting in patients with uncontrolled hypertension: Results from the HERCULES trial

Background : Atherosclerotic renal artery stenosis (ARAS) causes hypertension (HTN) and threatens renal function (RF). The HERCULES Trial is a prospective, multicenter trial of renal stenting in patients with uncontrolled HTN and ARAS evaluating the safety and effectiveness of the RX Herculink Elite Renal Stent System (Abbott Vascular, Santa Clara, CA). Results : Mean systolic blood pressure (SBP) at baseline was 162 mm Hg. Nearly 70% of patients were receiving three or more antihypertensive medications (mean 3.4 medications per patient). Baseline serum creatinine was 1.2 ± 0.4 and 61.5% of subjects had estimated glomerular filtration <60. The restenosis rate was 10.5% at 9 months. The study device, procedure, and clinical success rates were 96.0, 99.2, and 98.0%, respectively. Freedom from major adverse events was 94.8%. At 9 months, the mean SBP significantly decreased (mean 145, paired t test P < 0.0001) after stenting with no change in medications. There was no correlation between SBP reduction and baseline BNP or BNP reduction. 相似文献   

Surgical safety checklist: implementation in an ambulatory surgical facility

Purpose

In 2007, the World Health Organization created a Surgical Safety Checklist (SSC) that encompassed a simple set of surgical safety standards. The threefold purpose of this study was to add ambulatory-specific items to the SSC, to introduce the items into an ambulatory surgical facility, and to determine if patient outcomes regarding postoperative pain and nausea/vomiting improved following implementation. In addition, safety attitudes, antibiotic timing, regional anesthesia/nerve blocks, preemptive pain medications, prophylactic antiemetics, length of stay, and hospital admission were also assessed.

Methods

After Research Ethics Board approval, staff complete a Safety Attitudes Questionnaire. Seven items were added to the SSC. Data were then collected on 180 surgical cases before SSC implementation and 195 cases following implementation. Compliance with each section of the SSC was assessed.

Results

On postoperative day one, the median (97.5% confidence interval [CI]) difference between pre- and post-implementation pain scores was 0.5 (97.5% CI, 0 to 1; P = 0.13), and the median difference in the rate of post-discharge nausea/vomiting was ?8.4% (97.5% CI, ?17.9 to 1.1; P = 0.06). There was no improvement in safety attitudes or any of the secondary outcomes, with the exception of the use of preemptive pain medications. Compliance with the three sections of the checklist, i.e., BRIEFING, TIME OUT, and DEBRIEFING was 99.49%, 97.95%, and 96.92%, respectively. There was low compliance in verbalization of the added “ambulatory-specific items”.

Conclusion

Potential reasons for lack of uptake and integration include poor “user” buy-in, an overly lengthy checklist, and lack of prioritization of ambulatory-specific items. A shortened SSC was developed based on the results of this study. This trial was registered at ClinicalTrials.gov ID: NCT00934310.     

Fundamentals of randomized clinical trials in wound care: Reporting standards

In wound care research, available high‐level evidence according to the evidence pyramid is rare, and is threatened by a poor study design and reporting. Without comprehensive and transparent reporting, readers will not be able to assess the strengths and limitations of the research performed. Randomized clinical trials (RCTs) are universally acknowledged as the study design of choice for comparing treatment effects. To give high‐level evidence the appreciation it deserves in wound care, we propose a step‐by‐step reporting standard for comprehensive and transparent reporting of RCTs in wound care. Critical reporting issues (e.g., wound care terminology, blinding, predefined outcome measures, and a priori sample size calculation) and wound‐specific barriers (e.g., large diversity of etiologies and comorbidities of patients with wounds) that may prevent uniform implementation of reporting standards in wound care research are addressed in this article. The proposed reporting standards can be used as guidance for authors who write their RCT, as well as for peer reviewers of journals. Endorsement and application of these reporting standards may help achieve a higher standard of evidence and allow meta‐analysis of reported wound care data. The ultimate goal is to help wound care professionals make better decisions for their patients in clinical practice.     

Wound blotting: A convenient biochemical assessment tool for protein components in exudate of chronic wounds

Because wound exudate includes secreted proteins that affect wound healing, its biochemical analysis is useful for objective assessment of chronic wounds. Wound blotting allows for collection of fresh exudate by attaching a nitrocellulose membrane onto the wound surface. To determine its applicability for several analysis methods and its executability in clinical wound assessment, this study comprised an animal experiment and clinical case reports. In the animal experiment, full‐thickness wounds were created on the dorsal skin of mice, and exudate samples were collected daily by a conventional method and by wound blotting. Extremely small but adequate volumes of exudate were collected by wound blotting for subsequent analysis in the animal experiments. Immunostaining showed the concentration and distribution of tumor necrosis factor (TNF) α. The activity of alkaline phosphatase was visualized by reaction with chemiluminescent substrate. The TNF distribution analysis indicated three different patterns: wound edge distribution, wound bed distribution, and a mostly negative pattern in both the animal and clinical studies, suggesting association between the TNF distribution pattern and wound healing. Our results indicate that wound blotting is a convenient method for biochemical analysis of exudate and a candidate tool with which to predict the healing/deterioration of chronic ulcers.     

Predictive validity of granulation tissue color measured by digital image analysis for deep pressure ulcer healing: a multicenter prospective cohort study

This multicenter prospective cohort study examined the predictive validity of granulation tissue color evaluated by digital image analysis for deep pressure ulcer healing. Ninety‐one patients with deep pressure ulcers were followed for 3 weeks. From a wound photograph taken at baseline, an image representing the granulation red index (GRI) was processed in which a redder color represented higher values. We calculated the average GRI over granulation tissue and the proportion of pixels exceeding the threshold intensity of 80 for the granulation tissue surface (%GRI80) and wound surface (%wound red index 80). In the receiver operating characteristics curve analysis, most GRI parameters had adequate discriminative values for both improvement of the DESIGN‐R total score and wound closure. Ulcers were categorized by the obtained cutoff points of the average GRI (≤80, >80), %GRI80 (≤55, >55–80, >80%), and %wound red index 80 (≤25, >25–50, >50%). In the linear mixed model, higher classes for all GRI parameters showed significantly greater relative improvement in overall wound severity during the 3 weeks after adjustment for patient characteristics and wound locations. Assessment of granulation tissue color by digital image analysis will be useful as an objective monitoring tool for granulation tissue quality or surrogate outcomes of pressure ulcer healing.