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Mechanical thrombectomy devices for the management of pulmonary embolism 用于治疗肺栓塞的机械血栓清除装置
Pub Date : 2024-01-01 DOI: 10.1016/j.jvsvi.2024.100053
Yash K. Pandya MD , Edith Tzeng MD

Objective

The aim of this study was to review the most commonly used percutaneous mechanical thrombectomy devices for the treatment of pulmonary embolism today.

Methods

A thorough search of the existing literature was conducted on commonly used percutaneous mechanical thrombectomy devices, most notably Inari Flowtriever, Penumbra’s Indigo Aspiration, and Alphavac. Reported qualitative and quantitative information was abstracted and descriptively reviewed to ascertain the clinical utility and effectiveness of these devices.

Results

Inari Flowtriever is one of the most frequently utilized thrombectomy devices with the most substantive industry-sponsored trial data. Penumbra’s Indigo Aspiration is one of the up-and-coming devices that presents certain caveats in addition to the commonly utilized features of a percutaneous mechanical thrombectomy device, making it a viable alternative. Other newer devices such as Alphavac still lack substantial data, with some other lesser-known devices sporadically used and showing limited, primarily anecdotal evidence.

Conclusions

Each device has its positives and negatives. Data are growing on the clinical utility of these devices as their use is becoming more common. However, the long-term durability and overall cost-effectiveness remains to be determined.

本研究的目的是回顾当今治疗肺栓塞最常用的经皮机械血栓切除器械。方法对现有文献进行了全面检索,内容涉及常用的经皮机械血栓切除器械,主要包括 Inari Flowtriever、Penumbra 的 Indigo Aspiration 和 Alphavac。对报告的定性和定量信息进行了摘录和描述性审查,以确定这些设备的临床实用性和有效性。结果 Inari Flowtriever 是使用最频繁的血栓切除设备之一,拥有最多由行业赞助的试验数据。Penumbra 的 Indigo Aspiration 是一种新兴设备,它除了具有经皮机械血栓切除设备的常用功能外,还具有一些注意事项,因此是一种可行的替代设备。其他较新的设备,如 Alphavac,仍缺乏大量数据,其他一些不太知名的设备也只是零星使用,证据有限,主要是传闻。随着这些设备的使用越来越普遍,有关其临床效用的数据也在不断增加。不过,其长期耐用性和总体成本效益仍有待确定。
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引用次数: 0
Endovascular aortic repair for ruptured abdominal aortic aneurysm during the COVID-19 era COVID-19 时代的腹主动脉瘤破裂血管内修复术
Pub Date : 2024-01-01 DOI: 10.1016/j.jvsvi.2024.100073
Emily A. Grimsley MD, Haroon M. Janjua MS, Mark Asirwatham MD, Meagan D. Read MD, Paul C. Kuo MD, MS, MBA, Dean J. Arnaoutakis MD, Christopher A. Latz MD, MPH

Objective

The COVID-19 pandemic caused significant stress on health care systems, leading to altered care processes (ie, altered treatment algorithms, supply shortages, and personnel shortages). However, the effect of COVID and subsequent altered care processes on many surgical outcomes has not been characterized. In particular, patient outcomes after endovascular aortic repair (EVAR) for ruptured abdominal aortic aneurysm (rAAA) have not been well reported. Using COVID prevalence as a surrogate for altered processes of care, our aim is to determine changes in COVID-negative patient outcomes after EVAR for rAAA.

Methods

Using the Center for Disease Control COVID-19 data, COVID mortality per 3-month quarter was calculated in Florida. The quarters with the three highest mortality rates and three lowest mortality rates were used to establish COVID-heavy and COVID-light timeframes, respectively. Three quarters of 2019 were used for the pre-COVID timeframe for comparison. The Florida Agency for Health Care Administration database was queried using International Classification of Diseases-10 codes to identify patients diagnosed with rAAA who underwent EVAR during each timeframe. COVID-positive patients were excluded. Primary outcomes were in-hospital mortality, morbidity, and length of stay. Stepwise linear and logistic regression with 10-fold cross-validation determined which factors most impacted primary outcomes. Secondary outcomes included individual complication rates.

Results

A total of 316 patients were included. There were no significant differences in surgical volume, demographics, or comorbidities except that more patients had peripheral vascular disease in the COVID-light timeframe compared with the pre-COVID timeframe (P = .01). Mortality, length of stay, and complications were not significantly different per timeframe on univariable analysis. Regression confirmed that timeframe was not significantly associated with any primary outcome.

Conclusions

Despite increased stress on the health care system during the COVID-19 pandemic, outcomes after EVAR for rAAA were unchanged in Florida. These results imply that despite periods of COVID-heavy stress on the health care system, patient care was maintained at the pre-COVID standard of care.

目的 COVID-19 大流行给医疗系统造成了巨大压力,导致护理流程发生改变(即治疗算法改变、供应短缺和人员短缺)。然而,COVID 和随之改变的护理流程对许多手术结果的影响还没有定性。尤其是腹主动脉瘤破裂(rAAA)的血管内主动脉修补术(EVAR)后的患者预后尚未得到充分报道。我们的目的是利用 COVID 患病率作为护理流程改变的替代指标,确定 COVID 阴性患者在 rAAA EVAR 术后预后的变化。方法利用疾病控制中心 COVID-19 数据,计算佛罗里达州每 3 个月季度的 COVID 死亡率。死亡率最高的三个季度和死亡率最低的三个季度分别被用来建立 COVID 重度时间框架和 COVID 轻度时间框架。2019 年的三个季度被用于 COVID 前的时间框架进行比较。使用国际疾病分类-10代码查询佛罗里达州卫生保健管理机构数据库,以确定在每个时间框架内接受EVAR的确诊为rAAA的患者。COVID阳性患者被排除在外。主要结果为院内死亡率、发病率和住院时间。通过10倍交叉验证的逐步线性回归和逻辑回归确定了哪些因素对主要结果影响最大。次要结果包括个别并发症发生率。手术量、人口统计学或合并症方面无明显差异,但 COVID-light时间段与COVID前时间段相比,有更多患者患有外周血管疾病(P = .01)。在单变量分析中,死亡率、住院时间和并发症在不同时间段没有明显差异。结论尽管在 COVID-19 大流行期间医疗系统的压力增大,但佛罗里达州的 rAAA EVAR 术后结果没有变化。这些结果表明,尽管在 COVID 期间医疗系统承受了巨大压力,但患者护理仍保持了 COVID 前的护理标准。
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引用次数: 0
Twenty-five years of previous research establish that operating room utilization is an invalid metric of theatre productivity 此前 25 年的研究证实,手术室利用率是衡量手术室生产率的无效指标
Pub Date : 2024-01-01 DOI: 10.1016/j.jvsvi.2024.100118
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引用次数: 0
Benefits of lower limb angioplasty training using a virtual reality simulator among vascular surgical residents 血管外科住院医师使用虚拟现实模拟器进行下肢血管成形术培训的益处
Pub Date : 2024-01-01 DOI: 10.1016/j.jvsvi.2023.100043
Inez Ohashi Torres PhD , Nicole Inforsato MD , Sabine Wipper PhD , Erasmo Simão da Silva PhD , Pedro Puech-Leão PhD , Nelson De Luccia PhD

Background

We assessed the skill acquisition, operative competency, and confidence of vascular surgery residents during a limb angioplasty workshop and evaluated their surgical volume and retention rate at 1 year.

Methods

For 3 years (2018-2020), all residents and fellows in their final year of vascular residency at a teaching hospital were enrolled. Five residents in 2018 were enrolled in the control group (apprenticeship model). Twelve residents and fellows from 2019 (training group) and 2020 (coronavirus disease 2019 [COVID-19] group) were trained using the ANGIO Mentor (Simbionix Ltd, Airport City, Israel) in two workshops. The residents were evaluated using the Objective Structured Assessment of Technical Skills, simulator metrics, and a confidence questionnaire. A P value of < .05 was considered statistically significant.

Results

The groups were similar in age, sex, and number of limb angioplasties performed (control group, 25.00 ± 5.52; training group, 23.16 ± 7.44; COVID-19 group, 24.50 ± 8.17; P = .91, Student t test). The residents of the training and COVID-19 groups showed significantly improved Objective Structured Assessment of Technical Skills scores after the first workshop (from 15.5 [interquartile range (IQR), 12.62-19.13] to 29.5 [IQR, 25.25-39.38]; and from 14.50 [IQR, 13.62-15.00] to 23.5 [IQR, 21.87-24]; P < .001]; respectively) and reported confidence improvement (from a median of 3 [IQR, 3-3] to 4 [IQR, 4-5]; P = .01). After 6 months, the retention rate was good. During that semester, each resident performed a median of 10.50 limb angioplasties (IQR, 7.00-13.25 limb angioplasties). The second workshop did not improve either the residents' scores or their confidence. At the end of the year, the control group scored worse than did the training and control groups (control group, 23.50 [IQR, 19.00-24.50]; training group, 37.0 [IQR, 36.50-39.37]; COVID-19 group, 34.75 [IQR, 30.75-38.75]; P = .005, Kruskal-Wallis test). The simulation metrics did not show significant differences among the groups.

Conclusions

A 3-week limb angioplasty workshop can improve residents' skills and confidence. Performing 10 angioplasties per semester is sufficient to ensure the retention rate is good after 6 months, and a second workshop is unnecessary.

背景我们评估了血管外科住院医师在肢体血管成形术研讨会期间的技能掌握情况、手术能力和信心,并评估了他们的手术量和1年后的保留率。方法在3年内(2018-2020年),一家教学医院血管住院医师培训最后一年的所有住院医师和研究员都参加了研讨会。2018年的5名住院医师被纳入对照组(学徒模式)。来自 2019 年(培训组)和 2020 年(冠状病毒病 2019 [COVID-19] 组)的 12 名住院医师和研究员使用 ANGIO Mentor(以色列机场市 Simbionix 有限公司)在两次研讨会上接受了培训。使用技术技能客观结构化评估、模拟器指标和信心问卷对住院医师进行了评估。结果各组的年龄、性别和肢体血管成形术次数相似(对照组,25.00 ± 5.52;培训组,23.16 ± 7.44;COVID-19 组,24.50 ± 8.17;P = .91,学生 t 检验)。培训组和 COVID-19 组的住院医师在第一次研讨会后的技术技能客观结构化评估得分有了明显提高(从 15.5 [四分位距(IQR),12.62-19.13]到 29.5 [IQR, 25.25-39.38];以及分别从 14.50 [IQR, 13.62-15.00] 到 23.5 [IQR, 21.87-24];P <.001]),并报告了信心的提高(从中位数 3 [IQR, 3-3] 到 4 [IQR, 4-5];P = .01)。6 个月后,保留率良好。在该学期中,每名住院医师进行的肢体血管成形术中位数为 10.50 例(IQR,7.00-13.25 例)。第二期培训班既没有提高住院医师的分数,也没有增强他们的信心。学年结束时,对照组的得分低于培训组和对照组(对照组,23.50 [IQR,19.00-24.50];培训组,37.0 [IQR,36.50-39.37];COVID-19 组,34.75 [IQR,30.75-38.75];P = .005,Kruskal-Wallis 检验)。结论 为期三周的肢体血管成形术培训班可以提高住院医师的技能和信心。每学期进行 10 例血管成形术足以确保 6 个月后的良好保留率,因此无需举办第二期培训班。
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引用次数: 0
Association between aortic pathology, surgeon experience, and regional variability on use of intravascular ultrasonography during thoracic endovascular aortic repair 主动脉病理学、外科医生经验与胸腔内血管主动脉修复术中血管内超声成像使用的地区差异之间的关系
Pub Date : 2024-01-01 DOI: 10.1016/j.jvsvi.2023.100047
John J. Squiers MD , Jasjit K. Banwait PhD , Dan Neal MS , Salvatore T. Scali MD , William P. Shutze MD

Objective

Intravascular ultrasound (IVUS) is a useful adjunct to obtain precise intraluminal measurements during thoracic endovascular aortic repair (TEVAR), but IVUS examination is not routinely used by all surgeons or centers during TEVAR. We sought to identify patient- and system-related factors that influence the decision to use IVUS examination during TEVAR.

Methods

A retrospective review of the Vascular Quality Initiative (VQI) database was performed to identify all patients undergoing TEVAR from 2015 to 2019. Multivariable logistic regression modeling with three-fold repeated cross-validation was performed to identify predictors of IVUS use during TEVAR. Association of IVUS use with contrast volume and radiation exposure was also assessed.

Results

A total of 12,414 patients undergoing TEVAR met the inclusion criteria. Of these, IVUS examination was used in 41.3% of cases (n = 5121). IVUS use was more common in younger patients with fewer comorbidities; however, IVUS examination was also more commonly deployed in symptomatic patients and those with a higher preoperative American Society of Anesthesiology classification. IVUS examination was use in 80% (n = 3385/4213) TEVAR procedures performed for type B aortic dissection, which accounted for 50% of total IVUS use and only 11% of cases during which IVUS examination was not used (n = 822/7293) (P < .01). In multivariable analysis, the strongest independent predictor of IVUS use was aortic dissection (odds ratio, 13.7; 95% confidence interval, 11.7-16.3; P < .001, with aortic aneurysm as the reference). Surgeon years of independent practice experience was not associated with IVUS use, but when accounting for clustering on physicians and geographic regions, these variables explained 15% of the variance observed in the final risk-adjusted model. After adjustment for confounding factors, IVUS use was associated with a significant decrease in fluoroscopy time and contrast volume (both P < .001).

Conclusions

The decision to use IVUS examination during TEVAR is most heavily influenced by aortic pathology. Although surgeon experience was not associated with the decision to use IVUS examination, there was substantial variation in IVUS examination use among individual surgeons and VQI regions. IVUS use was associated with decreased contrast administration and fluoroscopy use but did not appear to have an impact on survival or re-intervention. Although aortic dissection was strongly associated with IVUS use, a significant number of TEVAR for dissection were performed without IVUS examination. Further research is warranted to identify the barriers to IVUS use as well as the risks and benefits of IVUS use during TEVAR so that quality benchmarks can be established and resource use is improved.

目的血管内超声(IVUS)是胸腔内主动脉修复术(TEVAR)期间获得精确腔内测量值的有用辅助手段,但并非所有外科医生或中心都在 TEVAR 期间常规使用 IVUS 检查。我们试图找出影响 TEVAR 期间使用 IVUS 检查决定的患者和系统相关因素。方法对血管质量倡议(VQI)数据库进行了回顾性审查,以确定 2015 年至 2019 年期间接受 TEVAR 的所有患者。采用三倍重复交叉验证的多变量逻辑回归模型来确定在 TEVAR 期间使用 IVUS 的预测因素。此外,还评估了IVUS的使用与造影剂用量和辐射暴露的关系。其中41.3%的病例(n = 5121)使用了IVUS检查。年轻且合并症较少的患者更常使用IVUS检查;然而,有症状的患者和术前美国麻醉学会分级较高的患者也更常使用IVUS检查。80%(n = 3385/4213)的 B 型主动脉夹层 TEVAR 手术使用了 IVUS 检查,占 IVUS 使用总数的 50%,仅占未使用 IVUS 检查病例的 11%(n = 822/7293)(P < .01)。在多变量分析中,使用 IVUS 的最强独立预测因素是主动脉夹层(几率比为 13.7;95% 置信区间为 11.7-16.3;P < .001,以主动脉瘤为参照)。外科医生的独立执业年限与IVUS的使用无关,但如果考虑到医生和地理区域的聚类,这些变量可以解释最终风险调整模型中观察到的15%的变异。在对混杂因素进行调整后,IVUS的使用与透视时间和造影剂用量的显著减少有关(P均为0.001)。虽然外科医生的经验与使用 IVUS 检查的决定无关,但不同外科医生和 VQI 地区在使用 IVUS 检查方面存在很大差异。IVUS的使用与造影剂用量和透视使用的减少有关,但似乎对存活率或再次介入没有影响。虽然主动脉夹层与 IVUS 的使用密切相关,但有相当数量的主动脉夹层 TEVAR 是在未进行 IVUS 检查的情况下进行的。有必要开展进一步研究,以确定使用 IVUS 的障碍以及在 TEVAR 期间使用 IVUS 的风险和益处,从而建立质量基准并提高资源利用率。
{"title":"Association between aortic pathology, surgeon experience, and regional variability on use of intravascular ultrasonography during thoracic endovascular aortic repair","authors":"John J. Squiers MD ,&nbsp;Jasjit K. Banwait PhD ,&nbsp;Dan Neal MS ,&nbsp;Salvatore T. Scali MD ,&nbsp;William P. Shutze MD","doi":"10.1016/j.jvsvi.2023.100047","DOIUrl":"10.1016/j.jvsvi.2023.100047","url":null,"abstract":"<div><h3>Objective</h3><p>Intravascular ultrasound (IVUS) is a useful adjunct to obtain precise intraluminal measurements during thoracic endovascular aortic repair (TEVAR), but IVUS examination is not routinely used by all surgeons or centers during TEVAR. We sought to identify patient- and system-related factors that influence the decision to use IVUS examination during TEVAR.</p></div><div><h3>Methods</h3><p>A retrospective review of the Vascular Quality Initiative (VQI) database was performed to identify all patients undergoing TEVAR from 2015 to 2019. Multivariable logistic regression modeling with three-fold repeated cross-validation was performed to identify predictors of IVUS use during TEVAR. Association of IVUS use with contrast volume and radiation exposure was also assessed.</p></div><div><h3>Results</h3><p>A total of 12,414 patients undergoing TEVAR met the inclusion criteria. Of these, IVUS examination was used in 41.3% of cases (n = 5121). IVUS use was more common in younger patients with fewer comorbidities; however, IVUS examination was also more commonly deployed in symptomatic patients and those with a higher preoperative American Society of Anesthesiology classification. IVUS examination was use in 80% (n = 3385/4213) TEVAR procedures performed for type B aortic dissection, which accounted for 50% of total IVUS use and only 11% of cases during which IVUS examination was not used (n = 822/7293) (<em>P</em> &lt; .01). In multivariable analysis, the strongest independent predictor of IVUS use was aortic dissection (odds ratio, 13.7; 95% confidence interval, 11.7-16.3; <em>P</em> &lt; .001, with aortic aneurysm as the reference). Surgeon years of independent practice experience was not associated with IVUS use, but when accounting for clustering on physicians and geographic regions, these variables explained 15% of the variance observed in the final risk-adjusted model. After adjustment for confounding factors, IVUS use was associated with a significant decrease in fluoroscopy time and contrast volume (both <em>P</em> &lt; .001).</p></div><div><h3>Conclusions</h3><p>The decision to use IVUS examination during TEVAR is most heavily influenced by aortic pathology. Although surgeon experience was not associated with the decision to use IVUS examination, there was substantial variation in IVUS examination use among individual surgeons and VQI regions. IVUS use was associated with decreased contrast administration and fluoroscopy use but did not appear to have an impact on survival or re-intervention. Although aortic dissection was strongly associated with IVUS use, a significant number of TEVAR for dissection were performed without IVUS examination. Further research is warranted to identify the barriers to IVUS use as well as the risks and benefits of IVUS use during TEVAR so that quality benchmarks can be established and resource use is improved.</p></div>","PeriodicalId":74034,"journal":{"name":"JVS-vascular insights","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S2949912723000442/pdfft?md5=62fbf8ef2ab477e0339351ad6a78fb26&pid=1-s2.0-S2949912723000442-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139188318","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Interacting with best practice advisory (BPA) notifications in the electronic medical record significantly improves screening rates for abdominal aortic aneurysms 与电子病历中的最佳实践建议 (BPA) 通知互动可显著提高腹主动脉瘤的筛查率
Pub Date : 2024-01-01 DOI: 10.1016/j.jvsvi.2023.100037
Kaylah Pinkney BS , Amin Mohamed Ahmed MD , Saideep Bose MD , Matthew Breeden MD , Matthew R. Smeds MD

Objective

Best practice advisory notifications (BPAs) have become an integral part of many electronic medical record (EMR) systems. These communications alert providers to recommended therapy or screenings for patients depending on factors found within the EMR. Our goal was to evaluate the impact of BPAs on the rate of abdominal aortic aneurysm (AAA) screening in patients who met guidelines for screening in a single-center EMR.

Methods

We reviewed all patients who triggered a BPA alert for AAA screening from December 2018 to December 2021 in a single tertiary academic setting. The BPA alerts the provider when closing the chart when a patient meets the criteria for AAA screening based on the United States Preventive Services Task Force recommendations of screening male patients aged 65 to 75 years with a smoking history. Provider responses to these triggers were analyzed, and the predictors of response to the advisory and its impact on AAA screening for individual patients within 6 months of the alert was evaluated.

Results

Over this period, 1292 patients triggered the BPA for AAA screening. After excluding deceased patients, 1205 patients were included in the final analysis. Providers interacted with rather than dismissed the BPA in 20.4% of patients. The overall screening rate in this patient cohort was 28.28%. Interacting with the BPA significantly increased the odds of being appropriately screened for a AAA (odds ratio, 2.48). A higher number of visits and BPA triggers correlated with increased odds of undergoing screening for AAA (odds ratios, 1.08 and 1.02, respectively). Additionally, patients who underwent screening were younger in age and more often African American as compared with other races. The presence and number of comorbid conditions were not associated with screening rates, although hyperlipidemia was associated with positive response to BPA.

Conclusions

The overall rate of appropriate AAA screening is low, despite the presence of BPAs. Positively interacting with rather than dismissing the BPA is correlated with an increased rate of appropriate AAA screening. Providers were more likely to screen patients if the patient was younger, had more health care system visits, or if the trigger was delivered more often to members of the health care team. Further study is needed to evaluate provider factors that will result in an increased adherence to recommended screening guidelines.

目标最佳实践建议通知(BPA)已成为许多电子病历(EMR)系统不可或缺的一部分。这些通信提醒医疗服务提供者根据 EMR 中发现的因素为患者推荐治疗或筛查。我们的目标是评估 BPA 对单个中心 EMR 中符合筛查指南的患者进行腹主动脉瘤(AAA)筛查率的影响。方法我们回顾了 2018 年 12 月至 2021 年 12 月在单个三级学术机构中触发 BPA 警报进行 AAA 筛查的所有患者。根据美国预防服务工作组关于对 65 至 75 岁有吸烟史的男性患者进行筛查的建议,当患者符合 AAA 筛查标准时,BPA 会在关闭病历时提醒医疗服务提供者。我们分析了医疗服务提供者对这些触发器的反应,并评估了在警报发出后 6 个月内对咨询反应的预测因素及其对单个患者 AAA 筛查的影响。结果在此期间,有 1292 名患者触发了 BPA 进行 AAA 筛查。在排除已故患者后,最终分析包括了 1205 名患者。在 20.4% 的患者中,医护人员与 BPA 进行了互动,而不是拒绝接受 BPA。该患者群的总体筛查率为 28.28%。与 BPA 互动可显著提高 AAA 适当筛查的几率(几率比为 2.48)。就诊次数和 BPA 触发次数越多,接受 AAA 筛查的几率越大(几率比分别为 1.08 和 1.02)。此外,与其他种族相比,接受筛查的患者年龄更小,更多是非裔美国人。合并症的存在和数量与筛查率无关,但高脂血症与对 BPA 的阳性反应有关。与 BPA 积极互动而不是拒绝接受 BPA 与 AAA 适当筛查率的提高有关。如果患者较年轻,在医疗保健系统就诊次数较多,或向医疗保健团队成员提供触发器的次数较多,则医疗服务提供者更有可能对患者进行筛查。还需要进一步研究,以评估医疗服务提供者的因素,从而提高对推荐筛查指南的依从性。
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引用次数: 0
Study design of the VenaSeal Spectrum Program: Two randomized controlled trials and one single-arm prospective study of a cyanoacrylate closure system to treat early to advanced chronic venous disease VenaSeal Spectrum 计划的研究设计:治疗早期至晚期慢性静脉疾病的氰基丙烯酸酯闭合系统的两项随机对照试验和一项单臂前瞻性研究
Pub Date : 2024-01-01 DOI: 10.1016/j.jvsvi.2024.100124

Background/Objective

Chronic venous disease (CVD) affects >25% of adults in developed countries. It is usually a progressive disease; if left untreated, can lead to advanced disease such as venous ulceration. The VenaSeal Spectrum Program compares the VenaSeal closure system (VenaSeal) to the global standards of care for CVD: endothermal ablation and surgical stripping. It also investigates VenaSeal's usefulness for patients with venous leg ulcers (VLUs). A key component of this clinical program was to measure and quantify patient satisfaction with treatments related to discomfort, healing time, and effectiveness, which often has been overlooked in CVD research. This article describes the rationale and design of the VenaSeal Spectrum Program for patients with CVD.

Methods

VenaSeal Spectrum is a prospective, postmarket, clinical trial program reporting outcomes from the periprocedural period through 5 years after treatment with VenaSeal. VenaSeal Spectrum has enrolled 506 participants at 32 sites in 10 countries requiring treatment for symptomatic Clinical, Etiological, Anatomical, and Pathophysiological Classification (CEAP) 2-6 CVD involving the truncal saphenous vein(s). The program is composed of three studies. Two randomized controlled trials compare VenaSeal ablation with either surgical stripping or endovenous thermal ablation in patients with symptomatic CEAP 2-5 disease. A single-arm prospective study investigates participants with active VLUs (CEAP 6) treated with VenaSeal. The unique primary end points for both randomized trials include both periprocedural and postprocedural patient treatment satisfaction measured by a new questionnaire (VenousTSQ) at 30 days post procedure and elimination of clinically relevant superficial truncal reflux in the target vein at index procedure. The primary end point for the VLU study is time to ulcer healing through 12 months. Secondary end points, which are more familiar to clinicians in this disease space, include time to return to work, complication rates, patient-reported outcome measures, and closure rates.

Conclusions

VenaSeal Spectrum is a rigorously designed clinical study program with a large study population and unique patient-centric end points after treatment with VenaSeal for early to advanced symptomatic CVD. The studies report on the safety, effectiveness, and patient experience outcomes including two new primary end points assessing the specific needs of patients with venous insufficiency from the periprocedural period through 5-year follow-up.

背景/目的慢性静脉疾病(CVD)影响着发达国家 25% 的成年人。它通常是一种进行性疾病;如果不及时治疗,可导致静脉溃疡等晚期疾病。VenaSeal Spectrum计划将VenaSeal闭合系统(VenaSeal)与治疗心血管疾病的全球标准:内热消融术和外科剥脱术进行比较。该项目还研究了 VenaSeal 对腿部静脉溃疡 (VLU) 患者的实用性。该临床项目的一个关键组成部分是测量和量化患者对治疗过程中的不适感、愈合时间和效果的满意度,这一点在心血管疾病研究中常常被忽视。本文介绍了针对心血管疾病患者的 VenaSeal Spectrum 项目的原理和设计。方法 VenaSeal Spectrum 是一项前瞻性、上市后临床试验项目,报告的是使用 VenaSeal 治疗后 5 年的疗效。VenaSeal Spectrum 已在 10 个国家的 32 个研究机构招募了 506 名参与者,他们都是需要治疗症状性临床、病因学、解剖学和病理生理学分类(CEAP)2-6 涉及躯干隐静脉的心血管疾病的患者。该计划由三项研究组成。两项随机对照试验比较了 VenaSeal 消融术与外科剥脱术或静脉腔内热消融术对有症状的 CEAP 2-5 疾病患者的治疗效果。一项单臂前瞻性研究调查了接受 VenaSeal 治疗的活动性 VLU(CEAP 6)患者。这两项随机试验的独特主要终点包括术前和术后患者的治疗满意度(通过术后30天的新问卷(VenousTSQ)进行测量),以及在索引手术中消除靶静脉中与临床相关的浅静脉回流。VLU 研究的主要终点是 12 个月内溃疡愈合的时间。结论VenaSeal Spectrum是一项设计严谨的临床研究项目,研究人群庞大,在使用VenaSeal治疗早期至晚期无症状心血管疾病后,具有独特的以患者为中心的终点。这些研究报告了安全性、有效性和患者体验结果,包括两个新的主要终点,评估静脉功能不全患者从围手术期到5年随访期间的特殊需求。
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引用次数: 0
Guidance to mitigate occupational risks for the pregnant vascular surgery trainee 降低怀孕血管外科实习生职业风险的指南
Pub Date : 2024-01-01 DOI: 10.1016/j.jvsvi.2024.100126

Increasing diversity among vascular surgeons and trainees has introduced a growing number of female trainees in vascular surgery, which necessitates the creation of guidelines that both support and protect those wishing to pursue family planning during training. The expectations of long work hours, clinical responsibilities, and radiation exposure associated with surgical training place pregnant trainees at increased risk for complications. These include intrauterine growth restriction, premature delivery, and postpartum depression. It is therefore important to establish guidelines that address the specific risks of training in vascular surgery to prioritize the health and well-being of pregnant trainees. Existing literature and recommendations surrounding support and protections for the pregnant individual and guidelines created for trainees desiring to start a family within other medical societies were reviewed and used to form the foundation for relevant recommendations to guide program directors in vascular surgery. While considering vascular surgery trainees’ unique risks and demands, guidance surrounding radiation exposure, clinical responsibilities, parental leave, and culture paradigms is described to establish minimum recommendations for training programs. Strategies to incorporate a culture of support to protect trainees are necessary to both recruit and retain talent within the field. Integration of this guidance into training programs is a crucial first step toward more successful recruitment of female talent and prevention of burnout and subsequently leading toward successful retention and satisfaction within the specialty.

随着血管外科医生和受训人员的日益多样化,血管外科的女性受训人员也越来越多,因此有必要制定相关指南,为希望在培训期间实行计划生育的人员提供支持和保护。与外科培训相关的长时间工作、临床责任和辐射暴露等期望,使怀孕的受训者面临更高的并发症风险。这些并发症包括宫内发育受限、早产和产后抑郁症。因此,针对血管外科培训的特殊风险制定指导方针,优先考虑怀孕学员的健康和福利非常重要。我们回顾了现有的文献和建议,这些文献和建议涉及对孕妇的支持和保护,以及其他医学会为希望组建家庭的受训者制定的指导方针,这些文献和建议为指导血管外科项目主任提出相关建议奠定了基础。考虑到血管外科学员的特殊风险和需求,本文介绍了围绕辐射暴露、临床责任、育儿假和文化范式的指导原则,为培训项目确立了最低限度的建议。为了在该领域招募和留住人才,有必要制定战略,融入支持文化以保护受训人员。将该指南纳入培训计划是关键的第一步,有助于更成功地招募女性人才、预防职业倦怠,进而成功留住本专业人才并提高其满意度。
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引用次数: 0
Need for and update on clinical trials for uncomplicated type B aortic dissection 无并发症 B 型主动脉夹层临床试验的必要性和最新进展
Pub Date : 2024-01-01 DOI: 10.1016/j.jvsvi.2024.100130
The mainstay of management for uncomplicated type B aortic dissection is currently optimal medical therapy, targeting blood pressure and heart rate, along with serial imaging. There is a paucity of data that informs whether early intervention with thoracic endografting in this group of patients will promote aortic remodeling and better long-term outcomes. Investigations to date, including the Investigation of Stent Grafts in Aortic Dissection (INSTEAD), INSTEAD-XL, and Acute Dissection: Stent Graft or Best Medical Therapy (ADSORB) studies, have compared thoracic endovascular aortic repair (TEVAR) with optimal medical therapy in patients with uncomplicated type B aortic dissection but have not shown a benefit for TEVAR conclusively. We discuss three major new randomized trials, which will recruit concurrently in Scandinavia (the Scandinavian trial of uncomplicated aortic dissection therapy [SUNDAY] trial), in the United States (the IMPRoving outcomes in vascular DisEase - aortic dissection [IMPROVE-AD] trial) and the United Kingdom (the Early aortic repair in patients needing endovascular surgery for type B aortic dissection [EARNEST] trial), which promise to provide conclusive, level 1 evidence to decipher whether early TEVAR in this cohort of patients in beneficial.
目前,治疗无并发症的 B 型主动脉夹层的主要方法是针对血压和心率的最佳药物治疗,以及连续成像。至于对这类患者进行胸腔内支架植入术的早期干预是否会促进主动脉重塑并改善长期预后,目前还缺乏相关数据。迄今为止,包括主动脉夹层中支架移植物的研究(INSTEAD)、INSTEAD-XL 和急性夹层在内的多项研究表明,主动脉夹层中支架移植物的治疗效果并不理想:支架移植物或最佳医疗疗法(ADSORB)研究)等研究对无并发症的 B 型主动脉夹层患者进行了胸腔内血管主动脉修复术(TEVAR)与最佳医疗疗法的比较,但并未明确显示 TEVAR 有益。我们将讨论三项新的重要随机试验,它们将同时在斯堪的纳维亚(斯堪的纳维亚无并发症主动脉夹层治疗试验 [SUNDAY] 试验)和美国(IMPR 试验)进行招募、这些试验有望提供确凿的 1 级证据,揭示早期 TEVAR 是否对这类患者有益。
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引用次数: 0
Approaches and considerations for optimal vessel sizing in peripheral vascular interventions 外周血管介入治疗中优化血管大小的方法和注意事项
Pub Date : 2024-01-01 DOI: 10.1016/j.jvsvi.2024.100092
Kajol Shah BS , Judit Csore MD , Trisha L. Roy BASc, MD, PhD, FRCSC, FACS

Background

Vessel sizing has played a pivotal role in guiding balloon and stent selection for coronary interventions, thereby decreasing dissections, vessel stress, and rates of restenosis. Despite its proven benefits in the coronaries, its application in peripheral vascular interventions has remained relatively underexplored.

Methods

This review aims to identify invasive and noninvasive imaging modalities available for sizing peripheral vessels as well as elucidate how vessel sizing is affected by measurement techniques, observer variability, and vessel characteristics.

Results

Traditionally, digital subtraction angiography (DSA) has been the gold standard for guiding vascular interventions. However, emerging techniques such as intravascular ultrasound (IVUS) examination and optical coherence tomography offer alternative approaches to vessel sizing, including assessment of cross-sectional area and minimal effective diameter.

Results

IVUS examination has demonstrated larger vessel diameter measurements and less intraobserver and interobserver variability than DSA. Whereas direct comparisons between IVUS examination and optical coherence tomography in the peripheries has been limited, noninvasive modalities such as computed tomography angiography and magnetic resonance angiography (MRA) provide a three-dimensional approach on vessel sizing, yet their integration into procedural planning remains constrained. Initial studies suggest discrepancies between vessel sizing using CTA and magnetic resonance angiography, warranting further investigation. Moreover, vessel characteristics such as localization and degree of calcification have been shown to influence balloon and stent sizing, highlighting the need for tailored approaches in peripheral vascular intervention.

Conclusions

Overall, although disparities exist between DSA and invasive/noninvasive imaging modalities in peripheral vessel sizing, the long-term implications of these differences on procedural outcomes remain poorly understood. Preliminary evidence suggests an opportunity to enhance procedural success, mitigate restenosis rates, and enhance patient care through improved vessel sizing techniques.

背景血管大小在指导冠状动脉介入的球囊和支架选择方面发挥了关键作用,从而减少了血管解剖、血管应力和再狭窄率。方法本综述旨在确定可用于确定外周血管大小的有创和无创成像模式,并阐明血管大小如何受到测量技术、观察者变异性和血管特征的影响。结果传统上,数字减影血管造影(DSA)一直是指导血管介入的黄金标准。然而,血管内超声(IVUS)检查和光学相干断层扫描等新兴技术为血管大小的确定提供了替代方法,包括横截面积和最小有效直径的评估。结果IVUS检查与DSA相比,血管直径测量值更大,观察者内部和观察者之间的变异性更小。虽然 IVUS 检查与光学相干断层扫描在外周的直接比较还很有限,但计算机断层扫描血管造影和磁共振血管造影 (MRA) 等无创模式提供了血管大小的三维方法,但它们与手术规划的整合仍受到限制。初步研究表明,使用计算机断层扫描和磁共振血管造影确定血管大小之间存在差异,值得进一步研究。此外,血管特征(如定位和钙化程度)已被证明会影响球囊和支架的大小,这凸显了在外周血管介入治疗中采用量身定制方法的必要性。结论总的来说,虽然 DSA 和有创/无创成像模式在外周血管大小方面存在差异,但这些差异对手术结果的长期影响仍鲜为人知。初步证据表明,通过改进血管大小技术,有机会提高手术成功率、降低再狭窄率并加强患者护理。
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引用次数: 0
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