Failed Retrieval of Inferior Vena Cava (IVC) Filters: Long-Term Outcomes
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 20
- 试验地点
- 1
研究概览
简要总结
The inferior vena cava (IVC) is a large vein that enters the bottom part of the heart. Venous blood from the lower portion of the body drains into the IVC. The IVC then returns blood back to the heart. An IVC filter is placed to help prevent the blood clots moving from the legs to the heart or lung. The idea behind using a filter in the IVC is to capture potential fatal pulmonary emboli at an anatomical location where they may pose less risk for the patient. Early filters, 1960's and 70's were, remained in the vein permanently. More recently, temporary or retrievable filters have been developed and are being widely used.
Complications have been demonstrated with long-term placement of IVC filters. In a randomised study it was found that that patients with IVC filter placement had greater than three times the incidence of recurrent deep vein thrombosis (DVT) compared to their control population at two years. Blockage of the vein, recurrent pulmonary emboli, filter penetration and filter fragmentation have all been described.
With the advent of retrievable filters (filters that can be place temporarily and then removed at a later date) there has been renewed popularity for placement of temporary filters. To our knowledge, no one has yet to follow the population of intended temporary IVC filters, who undergo failed retrieval, and consequently end up with a permanent IVC filter.
We plan to prospectively enrol 40 Alfred patients who have undergone a temporary IVC filter placement and subsequently have had failed IVC filter retrieval.
Our aim is to evaluate the long term outcomes for patients with failed IVC retrieval.
Specifically we will determine the risk, due to failed filter retrieval, of:
- IVC stenosis
- IVC occlusion
- Development of DVT and
- analyse the clinical outcomes (symptoms), their prevalence and their distribution
Patients will receive routine care and their data will be analysed annually as collected. The follow-up period is indefinite and will be at the discretion of the treating doctor.
详细描述
Clinical Study Protocol
Failed Retrieval of Inferior Vena Cava (IVC) filters: long-term outcomes
Study Objective To evaluate the long term outcomes for failed IVC retrieval.
Background Long-term placement of IVC filters is not without complication. Descosous et al. demonstrated that those patients with IVC filter placement had greater than three times the incidence of recurrent DVT at two years. Pulmonary Emboli (PE) have been reported. These can occur when there is no evidence of PE prior to insertion of the IVC filter. This was shown by Rogers et al where 2.3% of trauma patients receiving prophylactic filters developed a PE. They can also occur as a recurrence (i.e. where a PE has already been demonstrated prior IVC filter insertion) in 2.5 to 7.7 % of patients1, 2.
Caval thrombosis resulting in occlusion have been reported to occur in between 1-24% of cases depending on the type of filter3, 4. Guidewire and catheter entrapment during central venous and pulmonary artery catheter placement have also been reported as long term IVC filters become more prevalent. Filter penetration and filter fragmentation have all been described.
研究设计
- 研究类型
- Observational
- 观察模型
- Defined Population
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供