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1.

Background

A variety of devices exist for endovascular aneurysm repair (EVAR). Device-specific instructions for use (IFU) detail anatomic constraints to application and deployment of devices and are developed from rigorous bench testing. Nonadherence to IFU occurs frequently to avoid open surgery. The purpose of this study was to determine if IFU violations are associated with increased risk of graft-related adverse events (GRAEs) during follow-up.

Methods

This multicenter retrospective observational study included patients undergoing elective endovascular repair for abdominal aneurysmal disease with three different devices. Demographics, anatomic data, and follow-up data were collected on patients from 2005 to 2014. IFU violations were device specific and included neck diameter, length, and angulation and iliac artery diameter and length. GRAEs included a composite outcome of reintervention, migration, endoleak (type II excluded), rupture, limb occlusion, sac growth, and aneurysm-related mortality during the follow-up period. Kaplan-Meier survival and Cox proportional hazards modeling were performed. Any IFU violations as well as neck-specific IFU violations were analyzed.

Results

In 461 patients undergoing EVAR, 43.8% had at least one IFU violation. Patients with IFU violations were more likely to have peripheral vascular disease (12.4% vs 7.3%) and were less likely to be male (78.7% vs 90.3%). The most frequent IFU violations included diameter deviations of the neck (15.2%) and of the iliac artery (21.4%). Overall, the GRAE rate was 12.8%. Median follow-up time was 1.9 and 2.1 years for patients with and without an IFU violation, respectively. Kaplan-Meier survival revealed a significant association between the presence of an IFU violation and GRAEs (log-rank, P = .031). When adjusted for clinical variable through Cox hazard modeling, the association remained significant (hazard ratio 1.8; 95% confidence interval, 1.05-3.1). When neck-specific violations were considered independently, Kaplan-Meier survival (log-rank, P = .003) and Cox modeling (hazard ratio, 2.2; 95% confidence interval, 1.2-4.0) revealed a significant association between neck-specific IFU violation and GRAEs.

Conclusions

A total of 43.8% of patients undergoing EVAR had a device-specific IFU violation, indicating that implanters are pushing the boundaries of device capabilities. Our study identified that any IFU violation was significantly associated with GRAEs over time. Caution should be applied to patients being considered for EVAR when IFU deviations exist.  相似文献   
2.

Objective

To assess the mid-term outcomes and feasibility of branched endovascular repair (b-EVAR) of ruptured thoracoabdominal aortic aneurysms (rTAAAs).

Methods

All patients undergoing b-EVAR of rTAAAs between 2011 and 2016 were included. Pre-, intra and postoperative imaging was reviewed to assess technical success, outcomes, and feasibility of b-EVAR in the emergent setting.

Results

Eleven emergency b-EVAR of rTAAAs (10 aneurysms and 1 chronic dissection) were performed using off-the-shelf (OTS) branched stentgrafts. Only 18% of patients complied to the anatomical instruction-for-use of the OTS device; a small aortic lumen and occluded target vessels were the main violations. Median operative time was 430 (IQR 395-629) minutes. Technical failure was 36% including one intraoperative death, one target vessel catheterization failure, one type Ia and one type III endoleak. Thirty-day mortality was 27%. Only early re-intervention was for the type Ia endoleak. Spinal cord ischemia occurred in 4 patients (30%), of which 2 recovered completely. Median clinical follow-up were 15 (IQR 7-39) months respectively. The median clinical follow-up index (FUI) was 0.65 (0.32–0.95). Overall survival was 75 ± 21.7% at 18 months. Four branch occlusions occurred; one renal stent occlusion led to permanent hemodialysis. Branch patency was 87.5 ± 8.3% and 72.2 ± 12% at 1 and 2 years, respectively. One stentgraft migrated but no late major endoleak occurred.

Conclusion

Emergency b-EVAR of rTAAA with OTS device is feasible despite a low anatomical suitability. With proper adjunctive procedures, it can be offered to most hemodynamically stable patients. These time-consuming complex procedures are not suitable for unstable patients. Often the procedure is done as life-saving in the emergency setting and reinterventions may be needed later. Consequently, the success rates are lower than in the elective setting. These results need to be confirmed by larger studies and longer follow-up.  相似文献   
3.
This paper investigates the use of inverse finite-element modeling (IFEM)-based methods for tissue parameter identification using a rolling indentation probe for surgical palpation. An IFEM-based algorithm is proposed for tissue parameter identification through uniaxial indentation. IFEM-based algorithms are also created for locating and identifying the properties of an embedded tumor through rolling indentation of the soft tissue. Two types of parameter identification for the tissue tumor are investigated (1) identifying the stiffness (μ) of a tumor at a known depth and (2) estimating the depth of the tumor (D) with known mechanical properties. The efficiency of proposed methods has been evaluated through silicone and porcine kidney experiments for both uniaxial indentation and rolling indentation. The results show that both of the proposed IFEM methods for uniaxial indentation and rolling indentation have good robustness and can rapidly converge to the correct results. The tissue properties estimated using the developed method are generic and in good agreement with results obtained from standard material tests. The estimation error of μ through uniaxial indentation is below 3 % for both silicone and kidney; the estimation error of μ for the tumor through rolling indentation is 7–9 %. The estimation error of D through rolling indentation is 1–2 mm.  相似文献   
4.
ObjectiveTo compare intraoperative hemorrhage and other operative parameters after laparoscopically assisted vaginal hysterectomy (LAVH) versus total abdominal hysterectomy (TAH) for benign gynecologic conditions.DesignA prospective, randomized, controlled trial.Materials and MethodsBetween April 2010 and March 2011, 50 Thai patients with strong indications for hysterectomy—with uterine sizes ≤16 weeks of gravid uterus and with no contraindications for open or laparoscopic surgeries—were randomly assigned for LAVH or TAH.Main Outcome MeasuresIntraoperative blood loss, operating time, postoperative analgesic requirements, perioperative complications, and duration of hospitalization.ResultsIntraoperative blood loss was significantly less in the LAVH group (median 120 mL [range 50–300]) than in the TAH group (median 250 mL [105–800]) (median difference 130 mL, p <.001, 95% confidence interval [CI] 55–200). The LAVH group required significantly less postoperative morphine sulfate administration (median 3 mg [range 0–12]) than the TAH group (15 mg [6–24]) (median difference 9 mg, p <.001, 95% CI 9–12). The hospital stay for the LAVH group (median 3 days; range 2–7) was significantly shorter than that of the TAH group (median 4 days; range 4–5) (median difference 2 days, p <.001, 95% CI 1–2). The operating time was comparable between the 2 groups (median 100 minutes; range 50–240) for the LAVH and 115 minutes (range 60–200) for the TAH group (median difference 5 minutes, p =.592, 95% CI ?15–25). There were no conversions from a LAVH to a laparotomy.ConclusionsThe LAVH has advantages over the TAH in that in the former there is less intraoperative blood loss, less postoperative morphine requirement, and a shorter duration of postoperative hospital stays.  相似文献   
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6.

Purpose

This study aimed to evaluate the diagnostic properties of transabdominal sonography with the post-void technique for cervical length measurement.

Methods

This study was a prospective cohort study. The inclusion criteria were pregnant women aged 18–40 years with gestational age of 18–23 completed weeks. Transabdominal sonography with vertical bladder depth of less than 5 cm and transvaginal cervical length measurements were carried out by a single experienced sonographer.

Results

There were 307 eligible pregnant women. The mean age of all subjects was 29.0 years. The mean cervical length obtained through transabdominal and transvaginal measurement was 3.33 and 3.47 cm, respectively. Ten patients (3.3 %) were identified as having a short cervix using transvaginal sonography, and 12 patients (3.9 %) were identified using transabdominal sonography.

Conclusion

Transabdominal sonography with vertical bladder depth of less than 5 cm performed better compared with transvaginal sonography. It may not be necessary to perform transvaginal sonography if transabdominal sonography reveals the cervical length to be more than 2.5 cm.
  相似文献   
7.
Context: Previous studies have shown that extracts of Zizyphus rugosa Lam. (Rhamnaceae) bark contained phytoconstituents with antidiabetic potential to lower blood glucose levels in diabetic rats. However, there has been no report on the active compounds in this plant as potential antidiabetic inhibitors.

Objective: We evaluated the α-glucosidase inhibitory and antioxidant activities of Z. rugosa extract. Moreover, the active phytochemical constituents were isolated and characterized.

Materials and methods: The α-glucosidase inhibition of crude ethanol extract obtained from the bark of Z. rugosa was assayed as well as the antioxidant activity. Active compounds (1–6) were isolated, the structures were determined, and derivatives (2a–2?l) were prepared. All compounds were tested for their α-glucosidase inhibitory (yeast and rat intestine) and antioxidant (DPPH) activities.

Results: The active α-glucosidase inhibitors (1–6) were isolated from Z. rugosa bark and 12 derivatives (2a–2?l) were prepared. Compound 2 showed the most powerful yeast α-glucosidase inhibitory activity (IC50 16.3?μM), while compounds 3 and 4 display only weak inhibition toward rat intestinal α-glucosidase. Moreover, compound 6 showed the most potent antioxidant activity (IC50 42.8?μM). The molecular docking results highlighted the role of the carboxyl moiety of 2 for yeast α-glucosidase inhibition through H-bonding.

Discussion and conclusions: These results suggest the potential of Z. rugosa bark for future application in the treatment of diabetes and active compounds 1 and 2 have emerged as promising molecules for therapy.  相似文献   
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