Groot Jebbink Erik, van Wijck Iris, Holewijn Suzanne, Iida Osamu, Spinelli Domenico, Saxon Richard R, Zeller Thomas, Okhi Takao, Bosiers Marc, Reijnen Michel M P J
Department of Surgery, Rijnstate, Arnhem, The Netherlands.
Multi-Modality Medical Imaging Group, TechMed Center, University of Twente, Enschede, The Netherlands.
Catheter Cardiovasc Interv. 2022 Apr;99(5):1714-1722. doi: 10.1002/ccd.30152. Epub 2022 Mar 7.
The aim of the study was to analyze available data on patients treated for chronic limb-threatening ischemia (CLTI) with the heparin-bonded Viabahn endoprosthesis.
The patency of self-expanding covered stents in patients with complex femoropopliteal lesions is encouraging. However, data were mostly derived in patients with intermittent claudication. Patients with CLTI often have more advanced disease and worse outcome.
After the abstract screening, full-text papers were checked. Authors were approached to consider joining the consortium. Data were sent anonymously, databases were merged and an individual patient data meta-analysis was performed. Kaplan-Meier curves were used to calculate the freedom from amputations, the amputation-free survival, and patency rates.
Seven studies were enrolled, representing 161 limbs that were treated for CLTI. Median lesion length was 28.0 cm (interquartile range 25.0-33.0 cm) and 82.7% were chronic total occlusions. The technical success rate was 98.1% and the 30-day mortality 1.9%. Through 2-year follow-up, the freedom-from-major-amputations was 99.3%, with an amputation-free survival of 78.8%. The freedom-from-loss-of primary, primary-assisted, and secondary patency was 70.4%, 71.8%, and 88.2%, respectively, at 1-year and 59.5%, 62.7%, and 86.1% at 2-year follow-up, respectively. The reintervention-free survival was 62.2% at a 2-year follow-up.
Treatment of femoropopliteal disease in CLTI patients with the use of the heparin-bonded Viabahn is safe and effective with favorable clinical outcomes and low amputation rates. Reinterventions are needed in a subset of the population to maintain endoprosthesis patency. Close follow-up using duplex is recommended to detect potential edge stenosis, allowing treatment before device occlusion.
本研究旨在分析使用肝素涂层Viabahn血管内支架治疗慢性肢体威胁性缺血（CLTI）患者的现有数据。
自膨式覆膜支架在复杂股腘动脉病变患者中的通畅率令人鼓舞。然而，数据大多来自间歇性跛行患者。CLTI患者通常病情更严重，预后更差。
在摘要筛选后，检查全文论文。联系作者考虑加入联盟。数据匿名发送，合并数据库并进行个体患者数据荟萃分析。使用Kaplan-Meier曲线计算免于截肢率、无截肢生存率和通畅率。
纳入7项研究，代表161条接受CLTI治疗的肢体。病变中位长度为28.0 cm（四分位间距25.0 - 33.0 cm），82.7%为慢性完全闭塞。技术成功率为98.1%，30天死亡率为1.9%。经过2年随访，免于大截肢率为99.3%，无截肢生存率为78.8%。1年时，原发性、原发性辅助性和继发性通畅的免于丢失率分别为70.4%、71.8%和88.2%，2年随访时分别为59.5%、62.7%和86.1%。2年随访时无再次干预生存率为62.2%。
使用肝素涂层Viabahn治疗CLTI患者的股腘动脉疾病安全有效，临床结局良好，截肢率低。部分患者需要再次干预以维持血管内支架通畅。建议使用双功超声进行密切随访，以检测潜在的边缘狭窄，以便在装置闭塞前进行治疗。
