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Christine R. Herman Philippe Charbonneau Kiattisak Hongku Luc Dubois Sajjid Hossain Kevin Lee Oren K. Steinmetz 《Journal of vascular surgery》2018,67(1):126-133
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.
Kiattisak Hongku Björn Sonesson Katarina Björses Jan Holst Timothy Resch Nuno V. Dias 《European journal of vascular and endovascular surgery》2018,55(3):377-384
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.
Background: Previous studies have reported telaprevir is effective for chronic hepatitis C virus infection, but the safety of a telaprevir-based regimen remains uncertain. Objective: A meta-analysis was performed to assess the safety of the addition of telaprevir to a standard regimen of pegylated interferon (peginterferon) plus ribavirin (combination telaprevir with peginterferon plus ribavirin, the TPR group) compared with the standard regimen group (peginterferon plus ribavirin, the PR group). Methods and Results: Seven randomized controlled trials involving a total of 2808 patients were included in the meta-analysis. The addition of telaprevir to the standard regimen was associated with a significantly increased risk of serious adverse events compared with the standard PR group (relative risk [RR]?=?1.56; 95% confidence interval [CI] 1.21, 2.03; p?=?0.0007; I2?=?0%). Telaprevir was also associated with increased risk of treatment discontinuation (RR?=?2.10; 95% CI 1.56, 2.83; p?相似文献
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Satit Thiengwittayaporn Pitch Tangtrakul Natthapong Hongku Revit Tunyasuwanakul 《The Journal of arthroplasty》2021,36(4):1295-1301
BackgroundThe benefit of patellar denervation (PD) in patellar resurfacing total knee arthroplasty (TKA) is still debatable. This prospective, randomized controlled trial investigated whether circumferential PD should be performed in patellar resurfacing TKA.MethodsA total of 241 patients who underwent unilateral TKA were randomized into PD or non-PD groups. Incidence, intensity, and presentation time of anterior knee pain (AKP) and clinical outcomes were evaluated at 3, 6, 9, 12, 18, and 24 months postoperatively.ResultsThe incidence of AKP was significantly lower in the PD group (6.4% vs 16.2%, P = .032). The intensity of AKP and patient satisfaction scores were significantly better in the PD group at 3 months but not after 3 months. The presentation time of AKP mostly occurs at 3 months after surgery. The Knee Society score, range of motion, Oxford score, patellar score, activity of daily living score, and visual analog scale of overall knee pain were not significantly different between the two groups during the follow-up period.ConclusionGiven that PD can improve AKP and patient satisfaction at an early period postoperatively without jeopardizing clinical outcomes at no additional cost, this inexpensive procedure readily available in nearly every operation room is strongly recommended during primary TKA with patellar resurfacing. 相似文献
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Prospective study of Q-switched Nd:YAG laser treatment of hyperpigmented split-thickness skin grafts
Tonaree Warangkana Eimpunth Sasima Kamnerdnakta Sirichai Kongkunnavat Natthapong Chuangsuwanich Apirag 《Lasers in medical science》2022,37(5):2381-2386
Lasers in Medical Science - Hyperpigmentation of split-thickness skin grafts (STSGs) is commonly found among Asians, and it is also challenging to treat. Although the 1064-nm Q-switched Nd:YAG... 相似文献
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