Drug-Coated Balloons in Autologous Vein Peripheral-Distal Bypass Graft Maintenance: Advancements and Potential Impact.

IF 1.7 2区 医学 Q3 PERIPHERAL VASCULAR DISEASE Journal of Endovascular Therapy Pub Date : 2024-12-26 DOI:10.1177/15266028241307574
David Barillà, Giuseppe Roscitano, Graziana Derone, Vittorio Virga, Nunzio Montelione, Andrea Cutrupi, Francesco Costa, Maria Giulia Pascucci, Antonio Versace, Giampiero Vizzari, Francesco Spinelli, Efrem Civilini, Francesco Stilo, Antonio Micari
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引用次数: 0

Abstract

Introduction: Initial surgical revascularization has a recognized primary role in patients with critical limb-threatening ischemia with a high-quality great saphenous vein for conduit. However, approximately one-third of lower extremity vein grafts develop lesions threatening graft patency. Traditional treatments have limitations, highlighting the need for innovative solutions. The advantage of drug-coated balloons (DCBs) in treating native femoropopliteal occlusive disease is well established for its anti-restenotic features. This study evaluates the use of DCBs in maintaining the patency of autologous vein infrainguinal bypass grafts.

Methods: This retrospective multicenter cohort study included consecutive patients who underwent DCB angioplasty of infrainguinal bypass vein graft stenoses from January 2010 to December 2022 in 4 tertiary Vascular Surgery referral Centers. The primary endpoints were assisted primary patency rate, amputation, and death. All endpoints were assessed at baseline, at 1, 3, and 6 months, and every 6 months after the procedure. Follow-up was mainly performed via duplex ultrasound, by hand of an experienced independent operator.

Results: In total, 296 patients received an endovascular procedure for primary patency loss of a pre-existing infrainguinal saphenous vein bypass graft. Of these, 86 cases (29%) were treated with a paclitaxel-coated balloon. The mean age of patients was 72 (67-75) years, most being males (62%, n=53). The median time from the primary revascularization to reintervention with DCB was 2.58 (95% confidence interval [CI]: 2.31-3.10) years. The DCB angioplasty involved the proximal anastomosis in 20%, the graft in 51%, the distal anastomosis in 33%, and the outflow region in 28% of cases. During a median follow-up of 5 years (3.93-7.01), a 69% assisted primary patency rate was recorded. Limb salvage was achieved in 100% of cases at 1 year and in 90% of cases at 3 years. Only 6 cases of major amputation were recorded in a median follow-up time of 10 years. Overall survival reached 84% at 5 years, calculated on a median follow-up of 9.4 (95% CI: 8.7-10.1) years.

Conclusion: Results suggest that DCBs may have a transformative impact on vascular care, reducing the need for repeated reinterventions, and thus improving the quality of life for patients with peripheral bypass grafts.

Clinical impact: This study proposes a groundbreaking shift in the management of lower extremity vein graft lesions. By demonstrating the efficacy of drug-coated balloons (DCBs) in maintaining patency of infrainguinal vein bypass grafts, it offers clinicians a novel strategy to address a significant clinical challenge. Unlike traditional treatments with their limitations, DCBs present a promising alternative, potentially reducing the burden of repeated reinterventions. This innovation signifies a tangible improvement in patient outcomes, promising enhanced limb salvage rates and overall survival, thereby revolutionizing vascular care and enhancing the quality of life for individuals with peripheral bypass grafts.

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药物包被球囊在自体静脉外周-远端旁路移植术中的维持:进展和潜在影响。
导言:在有高质量大隐静脉作为导管的严重肢体缺血患者中,初始手术血运重建术具有公认的主要作用。然而,大约三分之一的下肢静脉移植物会出现危及移植物通畅的病变。传统的治疗方法存在局限性,因此需要创新的解决方案。药物包被球囊(DCBs)治疗先天性股腘动脉闭塞性疾病的优势因其抗再狭窄的特点而得到了充分的证实。本研究评估dcb在维持腹股沟下自体静脉旁路移植术通畅中的应用。方法:这项回顾性多中心队列研究纳入了2010年1月至2022年12月在4个三级血管外科转诊中心连续接受DCB血管成形术治疗腹股沟下旁路静脉狭窄的患者。主要终点为辅助原发性通畅率、截肢和死亡。在基线、1、3、6个月以及术后每6个月对所有终点进行评估。随访主要通过双超声进行,由经验丰富的独立操作者手工进行。结果:总共有296例患者接受了血管内手术,以治疗腹股沟下隐静脉旁路移植术的原发性通畅丧失。其中86例(29%)采用紫杉醇包被球囊治疗。患者平均年龄72岁(67 ~ 75岁),男性居多(62%,n=53)。从首次血运重建术到DCB再干预的中位时间为2.58年(95%可信区间[CI]: 2.31-3.10)。DCB血管成形术涉及近端吻合的占20%,移植物占51%,远端吻合的占33%,流出区占28%。在中位随访5年(3.93-7.01)期间,记录到69%的辅助原发性通畅率。100%的病例在1年和90%的病例在3年获得肢体保留。在中位随访时间为10年期间,仅记录了6例大面积截肢。5年总生存率达到84%,中位随访9.4年(95% CI: 8.7-10.1)。结论:结果表明,DCBs可能对血管护理产生变革性影响,减少了重复再干预的需要,从而提高了外周旁路移植患者的生活质量。临床影响:本研究提出了下肢静脉移植病变处理的突破性转变。通过证明药物包被球囊(DCBs)在维持腹股沟下静脉旁路移植术通畅方面的有效性,它为临床医生提供了一种新的策略来解决这一重大的临床挑战。与具有局限性的传统治疗方法不同,dcb提供了一种有希望的替代方法,可能会减少重复干预的负担。这一创新标志着患者预后的切实改善,有望提高肢体保留率和总体生存率,从而彻底改变血管护理,提高外周搭桥患者的生活质量。
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来源期刊
CiteScore
5.30
自引率
15.40%
发文量
203
审稿时长
6-12 weeks
期刊介绍: The Journal of Endovascular Therapy (formerly the Journal of Endovascular Surgery) was established in 1994 as a forum for all physicians, scientists, and allied healthcare professionals who are engaged or interested in peripheral endovascular techniques and technology. An official publication of the International Society of Endovascular Specialists (ISEVS), the Journal of Endovascular Therapy publishes peer-reviewed articles of interest to clinicians and researchers in the field of peripheral endovascular interventions.
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