干旱区生态环境知识资源中心(Arid): Interim Results of the PROMISE I Trial to Investigate the LimFlow System of Percutaneous Deep Vein Arterialization for the Treatment of Critical Limb Ischemia

Arid

	Interim Results of the PROMISE I Trial to Investigate the LimFlow System of Percutaneous Deep Vein Arterialization for the Treatment of Critical Limb Ischemia
	Mustapha, J. A.; Saab, Fadi A.; Clair, Daniel; Schneider, Peter
通讯作者	Mustapha, JA (corresponding author), Adv Cardiac & Vasc Amputat Prevent Ctr, 1525 E Beltline Ave NE,Suite 101, Grand Rapids, MI 49525 USA.
来源期刊	JOURNAL OF INVASIVE CARDIOLOGY
ISSN	1042-3931
EISSN	1557-2501
出版年	2019
卷号	31 期号:3 页码:57-63
英文摘要	Objective. To investigate the feasibility, safety, and effectiveness of the LimFlow stent-graft system in performing percutaneous deep vein arterialization (pDVA) for treatment of critical limb ischemia (CLI) patients ineligible for conventional endovascular or surgical revascularization procedures. Methods. Ten no-option CLI patients (mean age, 67 +/- 11 years: 30% women) were enrolled. All patients were classified as Rutherford class 5 or 6 and were deemed by a committee of experts to be ineligible for endovascular or surgical procedures to restore blood flow. Eighty percent were categorized as stage 4 (high risk of amputation) based on Society for Vascular Surgery wound, ischemia, and foot infection (SVS Wlfl) scoring index. The primary safety endpoint was amputation-free survival (AFS) at 30 days. A secondary safety endpoint evaluated AFS at 6 months. Other secondary endpoints included primary patency, wound healing, and technical success. Results. Amputation-free survival was achieved in 100% of patients, with no deaths or index limb above-ankle amputations observed at 30 days and 6 months. Technical success rate was 100%. No procedural complications were reported. Primary patency rates at 1 month and 6 months were 90% and 40%, respectively, with reintervention performed in 30% of patients. By 6 months. 30% of patients experienced complete (100%) wound healing, half of patients had 84%-93% wound healing, and 20% of patients experienced 60% healing. Conclusion. pDVA using the LimFlow system is a novel approach for treating patients with no-option CLI and may reduce amputation in this population for whom it would otherwise be considered inevitable. Initial findings from this early feasibility trial are promising and additional study is warranted.
英文关键词	critical limb ischemia desert foot stent-graft
类型	Article
语种	英语
收录类别	SCI-E
WOS记录号	WOS:000509894500011
WOS关键词	VENOUS ARTERIALIZATION ; SALVAGE ; BYPASS
WOS类目	Cardiac & Cardiovascular Systems
WOS研究方向	Cardiovascular System & Cardiology
资源类型	期刊论文
条目标识符	http://119.78.100.177/qdio/handle/2XILL650/369324
作者单位	[Mustapha, J. A.; Saab, Fadi A.] Adv Cardiac & Vasc Amputat Prevent Ctr, 1525 E Beltline Ave NE,Suite 101, Grand Rapids, MI 49525 USA; [Clair, Daniel] Palmetto Hlth DSC Med Grp, Columbia, SC USA; [Schneider, Peter] Kaiser Fdn Hosp, Honolulu, HI USA; [Schneider, Peter] Kaiser Permanente Med Grp, Honolulu, HI USA
推荐引用方式 GB/T 7714	Mustapha, J. A.,Saab, Fadi A.,Clair, Daniel,et al. Interim Results of the PROMISE I Trial to Investigate the LimFlow System of Percutaneous Deep Vein Arterialization for the Treatment of Critical Limb Ischemia[J],2019,31(3):57-63.
APA	Mustapha, J. A.,Saab, Fadi A.,Clair, Daniel,&Schneider, Peter.(2019).Interim Results of the PROMISE I Trial to Investigate the LimFlow System of Percutaneous Deep Vein Arterialization for the Treatment of Critical Limb Ischemia.JOURNAL OF INVASIVE CARDIOLOGY,31(3),57-63.
MLA	Mustapha, J. A.,et al."Interim Results of the PROMISE I Trial to Investigate the LimFlow System of Percutaneous Deep Vein Arterialization for the Treatment of Critical Limb Ischemia".JOURNAL OF INVASIVE CARDIOLOGY 31.3(2019):57-63.