Comparison of Complication Rates Associated with Permanent and Retrievable Inferior Vena Cava Filters: A Review of the MAUDE Database

PurposeTo compare the safety of permanent and retrievable inferior vena cava (IVC) filters by reviewing the U.S. Food and Drug Administration Manufacturer and User Facility Device Experience (MAUDE) database.Materials and MethodsThe MAUDE database was reviewed from January 1, 2009, to December 31, 2012. Product class search criteria were “filter, intravascular, cardiovascular.” Type of device used and specific adverse events (AEs) were recorded.ResultsFor the period January 2009–December 2012, 1,606 reported AEs involving 1,057 IVC filters were identified in the MAUDE database . Of reported AEs, 1,394 (86.8%) involved retrievable inferior vena cava filters (rIVCFs), and 212 (13.2%) involved permanent inferior vena cava filters (pIVCFs) (P < .0001). Reported AEs included fracture, migration, limb embolization, tilt, IVC penetration, venous thromboembolism and pulmonary embolism, IVC thrombus, and malfunctions during placement. Each specific AE was reported with significantly higher frequency in rIVCFs compared with pIVCFs. The most common reported complication with rIVCFs was fracture, whereas the most commonly reported complications with pIVCFs were placement malfunctions. For rIVCFs, the most commonly reported AE varied depending on filter brand.ConclusionsThe MAUDE database reveals that complications occur with significantly higher frequency with rIVCFs compared with pIVCFs. This finding suggests that the self-reported complication rate with rIVCFs is significantly higher than the self-reported complication rate with pIVCFs.     

A new adjustable temporary stent catheter for management of acute dissection during balloon angioplasty

Acute coronary dissection remains a limitation of percutaneous transluminal coronary angioplasty. For the management of acute coronary dissection, a new adjustable temporary stent catheter that can be positioned to the lesion, deployed, and retrieved at a later stage was developed. This catheter has at its distal end a spiral stent that can be reduced and expanded in a controlled fashion by external manipulations. The adjustable temporary stent catheter was applied in three clinical cases with acute coronary dissection during balloon angioplasty. In all cases, the adjustable temporary stent catheter restored blood flow when it was expanded to the lesion for 60 min and this restoration was maintained after device removal. It is envisioned that this temporary stent device may prove a useful means for the treatment of acute coronary dissection during percutaneous transluminal coronary angioplasty. © 1996 Wiley-Liss, Inc.     

临时性与永久性腔静脉滤器的合理选用与评价

深静脉血栓形成（DVT）所引发的致死性肺栓塞（PE）严重威胁国民的生命健康。目前,临床上针对DVT的治疗主要以抗凝为主,但即便给予足量的抗凝,仍有发生致死性PE的风险。下腔静脉滤器植入是防止DVT后继发致死性PE的有效手段。以往临床上应用的滤器通常为永久性滤器,但其在防止PE的同时,却增加了滤器植入后远期血栓性并发症的发生风险,因此限制了滤器的广泛应用。近年来,随着临时性及可回收性滤器的出现,给那些具有暂时抗凝禁忌或PE高危风险的病人带来了曙光,滤器植入的适应证也逐渐放宽。在滤器种类的选择上,要根据病人的不同情况以及对PE风险的评估结果做出个体化选择。     

中国首次小鼠的轨道飞行实验

利用我国返回式科学实验卫星，搭载装有２只小白鼠的生物舱，在近地球轨道上飞行８ｄ，初步观察飞行因素对小白鼠的影响。实验前对动物进行选训，挑选出体格健壮、对环境适应能力强的２只昆明种、雄性、成年小白鼠进行飞行。飞行前，对舱内仪器、设备和动物均进行消毒检疫处理。小白鼠在轨道上存活了５．４ｄ，由於失重原因，飞行后小鼠的骨形成率有降低趋势，力学特性无明显变化；小鼠脑、肺等组织残留了动物死亡前发生的血管性变化     

自胀式全覆膜可回收金属内支架在良性食道狭窄中的应用

目的 :探讨自制可回收金属覆膜内支架在缓解良性食道狭窄中的作用及效果。 方法 :在X线监视下 ,采用经口腔内支架置入回收术。 结果 :本组 15例患者支架均成功回收 ,吞咽困难缓解率达 10 0 % ,有 2例患者于术后 3个月再次发生食道狭窄 ,行第二次可回收支架置入术 ,症状缓解。 1例患者在术中行球囊扩张时造成食道纵隔瘘 ,被迫置入永久性支架。所有患者在术后 3个月、6个月复查时 ,食道均扩张良好 ,无严重并发症发生。 结论 :用可回收全覆膜支架治疗良性食道狭窄是一种安全有效的方法。     

可回收式锥形肝静脉支架的动物实验研究

目的 通过动物实验评估可回收式锥形肝静脉支架的可行性、安全性及稳定性,探讨支架回收最佳时间.方法 健康家猪24头,随机分为4组,每组6头.全身麻醉下经右颈内静脉入路接受肝中静脉可回收式锥形支架置入术,术后3、7、11、15 d分别接受支架回收.采用t检验对比各组支架置入后、回收前所测得的支架内血流压力变化差异.采集支架中段相邻血管组织标本作病理学检查,测量计算新生血管内膜厚度,单因素方差分析对比各组间新生内膜厚度差异.结果 24枚支架均成功置入,技术成功率100％;支架回收技术成功率为50％(12/24).肝中静脉内压力测量显示,3d组支架置入后与回收前比较,差异无统计学意义(P＜0.05);7 d组、11d组、15 d组支架置入后与回收前比较,差异有统计学意义(P＜0.05).各组间支架中段相邻组织新生内膜平均厚度两两比较,差异均有显著统计学意义(F=338.29,P＜0.001).结论 可回收式锥形支架置入家猪肝静脉安全、可行,其最佳安全回收时间为3d,最长不宜超过7d.     

A novel flexible endovascular stent for use in small and tortuous vessels

We assessed in vivo the mode of delivery, short-term patency and cellular response to a prototype endovascular stent. The stent is designed for delivery through a modified microcatheter and is retrievable with detachment from a delivery wire effected by electrolysis. We successfully deployed 12 stents in a range of sizes from 3–4 mm in straight and angled arteries of pigs. At control angiography 3 and 6 weeks later, nine arteries were patent, two occluded and one narrowed; patency was not related to vessel or stent size. The device shows promise as a stent for intracranial arteries since it can be delivered through microcatheters small enough for intracranial navigation and provides the operator with greater control than currently available self- or balloon-expanded stents. Received: 25 March 1998/Accepted: 7 May 1999     

Retrievable inferior vena cava filter utilization in obstetric patients

Objectives: The objective of this study is to evaluate patterns of use and outcomes of retrievable inferior vena cava filters (rIVCF) in obstetric patients.

Methods: A single center review of consecutive patients who underwent rIVCF placement during pregnancy/postpartum in 2005–2016. A pooled analysis of the relevant cases in the English literature was conducted.

Results: The current cohort comprised 24 women, median age 27 [interquartile range 24–30] years. Among 10 filters placed during pregnancy, the most common indication (n?=?4) was the need to withhold anticoagulation therapy before delivery, in the presence of acute thrombosis. In the postpartum period, most filters (64%, 9/14) were an adjunct to catheter-directed thrombolytic therapy. Inferior vena cava filters (IVCF)-related complications occurred in seven (29.2%). Retrieval was attempted in 21 patients (87.5%), and was technically successful in 19 (90.5%), for an overall removal rate of 79.1%. Pooled analysis of the literature (n?=?98) showed comparable rates for filter removal and complications (81.6%, p?=?.78 and 24.2%, p?=?.60, respectively). Suprarenal placement (p?=?.12) and elective cesarean section (p?=?.19) did not reduce overall complication and retrieval rates. The estimated radiation dose among pregnant patients who underwent rIVCF placement without adjunct catheter directed thrombolysis (CDT) (mean 695?Gy cm²) was significantly lower than the radiation dose used in postpartum patients (1863?Gy cm²) or in pregnant patients in whom adjunct CDT was utilized (4059?Gy cm²) (p?=?.001 for both comparisons).

Conclusions: Frequent rIVCF-related complications, radiation exposure, and removal failure call for their cautious utilization in obstetric patients. The role of suprarenal placement and elective cesarean section to improve outcomes has yet to be established.     

Indications, management, and complications of temporary inferior vena cava filters

Purpose: We describe the results of a preliminary prospective study using different recently developed temporary and retrievable inferior vena cava (IVC) filters. Methods: Fifty temporary IVC filters (Günther, Günther Tulip, Anthéor) were inserted in 47 patients when the required period of protection against pulmonary embolism (PE) was estimated to be less than 2 weeks. The indications were documented deep vein thrombosis (DVT) and temporary contraindications for anticoagulation, a high risk for PE, and PE despite DVT prophylaxis. Results: Filters were removed 1–12 days after placement and nine (18%) had captured thrombi. Complications were one PE during and after removal of a filter, two minor filter migrations, and one IVC thrombosis. Conclusion: Temporary filters are effective in trapping clots and protecting against PE, and the complication rate does not exceed that of permanent filters. They are an alternative when protection from PE is required temporarily, and should be considered in patients with a normal life expectancy.     

一体式可回收胆管内塑料支架在恶性胆道疾病中的应用效果

目的 探讨一体式可回收胆管内塑料支架在恶性胆道梗阻疾病治疗中的应用时效性和安全性。方法 回顾性收集2019年1月－2022年5月于该院行内镜逆行胰胆管造影术（ERCP）治疗的恶性胆道梗阻患者81例。其中,25例置入一体式可回收胆管内塑料支架（一体支架组）,23例置入普通塑料支架（普通支架组）,33例置入金属覆膜支架（金属支架组）。比较3组患者的肝功能变化、支架通畅时间、反流发生率、术后胰腺炎发生率、单次住院时间和住院费用。结果 3组患者置入支架前肝功能比较,差异无统计学意义（P > 0.05）;一体支架组和金属支架组较普通支架组总胆红素（TBIL）、直接胆红素（DBIL）指标下降趋势更为明显,且一体支架组DBIL指标下降程度较金属支架组明显（P < 0.05）。金属支架组支架通畅时间最长,为（184.70±16.40）d,一体支架组次之,为（118.64±16.00）d,普通支架组通畅时间最短,为（96.43±15.85）d,3组患者比较,差异有统计学意义（P < 0.05）。一体支架组反流发生率最低,金属支架组其次,普通支架组反流发生率最高,3组患者比较,差异有统计学意义（P < 0.05）。3组患者胰腺炎发生率和单次住院时间比较,差异均无统计学意义（P > 0.05）。金属支架组住院费用较一体支架组和普通支架组高,3组患者比较,差异有统计学意义（P < 0.05）。结论 相比金属覆膜支架和普通塑料支架,一体式可回收胆管内塑料支架置入术后,肝功能恢复较好,支架通畅时间相对较长,反流发生率较低,住院费用少,且安全有效,是恶性胆道梗阻患者的最优选择。