Cassius Iyad Ochoa Chaar, Eric K Peden, Eric S Hager, Claire L Griffin, Matthew R Smeds
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This study aimed to show that bioprosthetic valve implantation yields clinically meaningful health improvements and offers a safe and effective treatment for deep venous CVI by addressing the root cause of the condition.</p><p><strong>Methods: </strong>SAVVE (Surgical Antireflux Venous Valve Endoprosthesis) was a prospective, single-arm, multicenter study to evaluate the performance of a bioprosthetic venous valve device (VenoValve; enVVeno Medical), for femoral vein implantation in patients with venous disease (Clinical-Etiology-Anatomy-Pathophysiology clinical classifications C4b, C4c, C5, and C6) unresponsive to standard care. Outcome measures included duplex-derived reflux time, the Revised Venous Clinical Severity Score (rVCSS), pain, disease-specific (VEINES-QoL/Sym) and general health-related quality of life (EuroQol 5 Dimensions) measures, technical success of device implantation, ulcer healing (C6 patients), and ulcer recurrence (in C5 and C6 patients). Clinically meaningful improvement was defined as a decrease in rVCSS of at least 3 points.</p><p><strong>Results: </strong>Between October 2021 and September 2023, 75 patients were enrolled (median age, 65 years; interquartile range, 57-70 years) at 23 institutions. Of the enrolled patients, 61 (81.3%) were men and 16 (21.3%) were Black, Hispanic, or Latino. The device was implanted in 73 patients (97.3%). At 6 months, 23 of 67 implanted patients (34.3%) had a 30% or greater improvement in duplex-derived reflux time. Average rVCSS score improvements were clinically meaningful and statistically significant at 3, 6, and 12 months. At 12 months, 84.6% of implanted patients achieved clinically meaningful improvement, with an average improvement of 7.9 points in rVCSS. Statistically significant improvements in pain and health-related quality of life were reported through 12 months of follow-up. Among patients with C6 disease, healing was observed for 91.6% of ulcers that had a duration of less than 12 months. No unanticipated device-related adverse events were reported. The perioperative major adverse events rate was 30.7% with no mortality. Most patients with major adverse events achieved clinically meaningful improvement in symptoms.</p><p><strong>Conclusions: </strong>Implantation of the bioprosthetic venous valve yielded important clinical and health-related quality of life benefits in patients with severe CVI.</p>","PeriodicalId":17537,"journal":{"name":"Journal of vascular surgery. 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This study aimed to show that bioprosthetic valve implantation yields clinically meaningful health improvements and offers a safe and effective treatment for deep venous CVI by addressing the root cause of the condition.</p><p><strong>Methods: </strong>SAVVE (Surgical Antireflux Venous Valve Endoprosthesis) was a prospective, single-arm, multicenter study to evaluate the performance of a bioprosthetic venous valve device (VenoValve; enVVeno Medical), for femoral vein implantation in patients with venous disease (Clinical-Etiology-Anatomy-Pathophysiology clinical classifications C4b, C4c, C5, and C6) unresponsive to standard care. Outcome measures included duplex-derived reflux time, the Revised Venous Clinical Severity Score (rVCSS), pain, disease-specific (VEINES-QoL/Sym) and general health-related quality of life (EuroQol 5 Dimensions) measures, technical success of device implantation, ulcer healing (C6 patients), and ulcer recurrence (in C5 and C6 patients). Clinically meaningful improvement was defined as a decrease in rVCSS of at least 3 points.</p><p><strong>Results: </strong>Between October 2021 and September 2023, 75 patients were enrolled (median age, 65 years; interquartile range, 57-70 years) at 23 institutions. Of the enrolled patients, 61 (81.3%) were men and 16 (21.3%) were Black, Hispanic, or Latino. The device was implanted in 73 patients (97.3%). At 6 months, 23 of 67 implanted patients (34.3%) had a 30% or greater improvement in duplex-derived reflux time. Average rVCSS score improvements were clinically meaningful and statistically significant at 3, 6, and 12 months. At 12 months, 84.6% of implanted patients achieved clinically meaningful improvement, with an average improvement of 7.9 points in rVCSS. Statistically significant improvements in pain and health-related quality of life were reported through 12 months of follow-up. 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引用次数: 0
摘要
目的:深静脉瓣膜失效和相关的反流导致慢性静脉功能不全(CVI)的进展,最终导致疼痛、临床挑战和代价高昂的腿部溃疡。传统的CVI治疗主要集中在症状管理,或对浅静脉的干预。本研究旨在表明生物人工瓣膜植入术可以改善临床健康状况,并通过解决深层静脉CVI的根本原因,为其提供安全有效的治疗方法。方法:SAVVE研究是一项前瞻性、单臂、多中心研究,旨在评估生物假体静脉瓣膜装置(VenoValve; enVVeno Medical, Irvine, California)用于对标准治疗无反应的静脉疾病(CEAP临床分类C4b、C4c、C5和C6)患者股静脉植入的性能。结果测量包括双源性反流时间、修订静脉临床严重程度评分(rVCSS)、疼痛、疾病特异性(veins - qol /Sym)和一般健康相关生活质量(EQ-5D)测量、装置植入的技术成功、溃疡愈合(C6患者)和溃疡复发(C5和C6患者)。临床意义的改善定义为rVCSS降低至少3个点。结果:在2021年10月至2023年9月期间,共有23家机构的75名患者入组(中位年龄65岁,四分位数范围为57至70岁)。在纳入的患者中,61例(81.3%)为男性,16例(21.3%)为黑人、西班牙裔或拉丁裔。植入术73例(97.3%)。6个月时,67例植入患者中有23例(34.3%)双源性反流时间改善30%或以上。平均rVCSS评分改善在3、6和12个月时具有临床意义和统计学意义。在12个月时,84.6%的植入患者获得了有临床意义的改善,rVCSS平均改善7.9分。在12个月的随访中,疼痛和健康相关生活质量均有统计学上的显著改善。在C6疾病患者中,91.6%的溃疡持续愈合。结论:生物假静脉瓣膜的植入对严重CVI患者的临床和健康相关的生活质量有重要的益处。
SAVVE US pivotal study of patients with severe chronic insufficiency due to deep valvular venous reflux: One-year results after VenoValve implantation.
Objective: Failure of deep venous valves and associated reflux leads to the progression of chronic venous insufficiency (CVI), culminating in painful, clinically challenging, and costly leg ulcers. Traditional CVI treatments have primarily focused on symptom management, or interventions for superficial veins. This study aimed to show that bioprosthetic valve implantation yields clinically meaningful health improvements and offers a safe and effective treatment for deep venous CVI by addressing the root cause of the condition.
Methods: SAVVE (Surgical Antireflux Venous Valve Endoprosthesis) was a prospective, single-arm, multicenter study to evaluate the performance of a bioprosthetic venous valve device (VenoValve; enVVeno Medical), for femoral vein implantation in patients with venous disease (Clinical-Etiology-Anatomy-Pathophysiology clinical classifications C4b, C4c, C5, and C6) unresponsive to standard care. Outcome measures included duplex-derived reflux time, the Revised Venous Clinical Severity Score (rVCSS), pain, disease-specific (VEINES-QoL/Sym) and general health-related quality of life (EuroQol 5 Dimensions) measures, technical success of device implantation, ulcer healing (C6 patients), and ulcer recurrence (in C5 and C6 patients). Clinically meaningful improvement was defined as a decrease in rVCSS of at least 3 points.
Results: Between October 2021 and September 2023, 75 patients were enrolled (median age, 65 years; interquartile range, 57-70 years) at 23 institutions. Of the enrolled patients, 61 (81.3%) were men and 16 (21.3%) were Black, Hispanic, or Latino. The device was implanted in 73 patients (97.3%). At 6 months, 23 of 67 implanted patients (34.3%) had a 30% or greater improvement in duplex-derived reflux time. Average rVCSS score improvements were clinically meaningful and statistically significant at 3, 6, and 12 months. At 12 months, 84.6% of implanted patients achieved clinically meaningful improvement, with an average improvement of 7.9 points in rVCSS. Statistically significant improvements in pain and health-related quality of life were reported through 12 months of follow-up. Among patients with C6 disease, healing was observed for 91.6% of ulcers that had a duration of less than 12 months. No unanticipated device-related adverse events were reported. The perioperative major adverse events rate was 30.7% with no mortality. Most patients with major adverse events achieved clinically meaningful improvement in symptoms.
Conclusions: Implantation of the bioprosthetic venous valve yielded important clinical and health-related quality of life benefits in patients with severe CVI.
期刊介绍:
Journal of Vascular Surgery: Venous and Lymphatic Disorders is one of a series of specialist journals launched by the Journal of Vascular Surgery. It aims to be the premier international Journal of medical, endovascular and surgical management of venous and lymphatic disorders. It publishes high quality clinical, research, case reports, techniques, and practice manuscripts related to all aspects of venous and lymphatic disorders, including malformations and wound care, with an emphasis on the practicing clinician. The journal seeks to provide novel and timely information to vascular surgeons, interventionalists, phlebologists, wound care specialists, and allied health professionals who treat patients presenting with vascular and lymphatic disorders. As the official publication of The Society for Vascular Surgery and the American Venous Forum, the Journal will publish, after peer review, selected papers presented at the annual meeting of these organizations and affiliated vascular societies, as well as original articles from members and non-members.