射频闭合术国外文献及指南解读课件

1、静脉射频术国外文献及指南解读21.流行病学2.病因及病理生理3.诊断及临床分级4.治疗5.国外文献及本中心经验 内容大纲 流行病学全球患慢性静脉功能不全(CVI)或静脉曲张的患者超过1亿9000万人美国患病率约23%男性：1100万女性：2200万患者年龄40-80岁仅190万患者寻求治疗我国静脉曲张患者约1亿以上，发病率为15%左右3欧洲发病率为20%-50%其中英国占20%-40% 4,5Gloviczki P,et al.J Vasc Surg. 2011 May;53(5 Suppl):2S-48S.London: National Institute for Health and C

2、are Excellence (UK); 2013 Jul. 刘凯,等.血管与腔内血管外科杂志.2016;2(2):166-172.Chwaa M,et al.Adv Clin Exp Med. 2015 Jan-Feb;24(1):5-14. Carroll C,et al.Br J Surg. 2014 Aug;101(9):1040-52. 影响所有年龄的人群1患病率是PAD的10倍1美国每年CVI的直接花费预计为1亿5千万到10亿美元2住院患者CVI平均发病率为92/100,0003每年至少有20,556名患者被确诊为静脉性溃疡41 Gordon P, Treat-Jacobson D

3、, Sossoman L.B. Society for Vascular Nursing Position Statement on Inclusion of Vascular Disease into Nursing Education. Soc for Vascular Nursing. 2012;Sept:10. 2 Heller J. Treatment of chronic venous insufficiency. Supplement to Endovascular Today. 2011;Oct:12-15. 3 Weiss R, Venous Insufficiency. M

4、edscape. November 21, 2012. 4 Gloviczki P, Comerota A.J, Dalsing M.C et al. The care of patients with varicose veins and associated chronic venous diseases: Clinical practice guidelines of the Society for Vascular Surgery and the American Venous Forum. J Vasc Surg. 2011;53(suppl):2S-48S. 流行病学超过3千万美国

5、人患有静脉曲张或慢性静脉疾病(CVI)(一种更严重的静脉疾病)1在这3千多万美国人中：仅有190万每年会寻求治疗1,2绝大多数仍未确诊或未接受治疗CVI患病率1,2*30,000,000寻求治疗*21,900,000接受治疗447,0002*统计数据来源于40岁以上的个体1 Gloviczki P, et al. The care of patients with varicose veins and associated chronic diseases: clinical practice guidelines of the Society for Vascular Surgery and

6、 the American Venous Forum. JVS; May 2011. 2 Lee, A. US markets for varicose vein treatment devices 2011. Millennium Research Group, Inc. (A Decision Resource, Inc. Company), , May 2011. 流行病学61.流行病学2.病因及病理生理3.诊断及临床分级4.治疗5.国外文献及本中心经验 内容大纲风险因素其他可能性风险因素*高龄家族史DVT肥胖久立妊娠女性吸烟高血压口服避孕药或激素替代治疗体力活动便秘*不同研究结果存在差

7、异Beebe-Dimmer Jl, Pfeifer JR, Engle, JS, et al. The Epidemiology of Chronic Venous Insufficiency and Varicose Veins. Ann Epidemiol. 2005;15(3):175-184. 病因及病理生理正常静脉曲张静脉小腿肌肉收缩迫使静脉血流向心脏静脉功能正常的小腿肌肉泵一次肌肉收缩可以排空40%-60%的血液步行7-12步=静脉压从100mmHg降至22mmHgMeissner MH, Gloviczki P, Bergan J, et al. J Vasc Surgery.

8、2007;46(suppl):4S-24S. 病因及病理生理返流的发生/发展图片由Dr. Labropoulos提供下肢任意浅静脉或深静脉都可能发生主静脉反流，但是前者更频繁隐静脉及其支静脉扩张或曲张通常无明显症状Labropoulos N, et al. J Vasc Surg. 2010;51:96-103 . 瘤样扩张 病因及病理生理101.流行病学2.病因及病理生理3.诊断及临床分级4.治疗5.国外文献及本中心经验 内容大纲2022/7/27111.体格检查GRADE of recommendationLevel of evidence1.1对于CVD患者建议完善视诊、触诊及听诊检查，

9、并详细询问患者症状1A2.多普勒超声2.1对于CVD患者建议超声辅助体格检查及问诊1A3.体积描记法3.2对于超声无法明确病因的严重CVD（C3-C6）建议容积描记法检查1B2011版 美国血管外科协会&美国静脉论坛Clinical practice guidelines of the Society for Vascular Surgery and the American Venous Forum 2011Gloviczki P,et al.J Vasc Surg. 2011 May;53(5 Suppl)2S-48S. 诊断及临床分级2022/7/27122011版 美国血管外科协会&美

10、国静脉论坛6分级GRADE of recommendationLevel of evidence6.1建议CEAP分级作为静脉曲张疾病临床分级。1AClinical practice guidelines of the Society for Vascular Surgery and the American Venous Forum 2011Gloviczki P,et al.J Vasc Surg. 2011 May;53(5 Suppl)2S-48S. 诊断及临床分级CEAP(临床/病因学/解剖学/病理生理学)C级C0静脉疾病没有可见的或明显指征C1毛细血管扩张或蛛状静脉C2静脉曲张C3

11、水肿C4a色素沉着和/或湿疹C4b脂性硬皮病和/或白色萎缩C5愈合性静脉溃疡C6活动性静脉溃疡C1毛细血管扩张或网状静脉C2静脉曲张C3水肿图片由 Jennifer A. Heller, MD提供CEAP(临床/病因学/解剖学/病理生理学)C级图片由 Gordon Gibbs, M.D. 和Jennifer A. Heller, MD提供C4a:色素沉着或湿疹C4b:脂性硬皮病或白色萎缩C5:愈合性静脉溃疡C6:活动性静脉溃疡CEAP(临床/病因学/解剖学/病理生理学)C级P: Pathophysiological ClassificationPr: refluxPo: obstruction

12、Pr,o: reflux and obstructionPn: no venous pathophysiology identifiableE: Etiological ClassificationEc: congenitalEp: primary (undeterminate cause)Es: secondary (e.g. post thrombotic)En: no venous cause identifiedA: Anatomical ClassificationAs: superficial veinsAp: perforator veinsAd: deep veinsAn: n

13、o venous location identifiedCEAP(临床/病因学/解剖学/病理生理学)级Clinical practice guidelines of the Society for Vascular Surgery and the American Venous Forum 2011Gloviczki P,et al.J Vasc Surg. 2011 May;53(5 Suppl)2S-48S.171.流行病学2.病因及病理生理3.诊断及临床分级4.治疗5.国外文献及本中心经验 内容大纲2011版 美国血管外科协会&美国静脉论坛药物治疗GRADE of recommendat

14、ionLevel of evidence8.1对于CVD导致下肢肿胀、疼痛患者建议使用静脉活性药物治疗2B8.2对于溃疡患者建议已酮可可碱或微粒化黄酮配合弹力袜促进愈合2B压力治疗9.1对于症状性静脉曲张患者建议中等压力（20-30mmHg）治疗2C9.2对于预计接受静脉曲张手术患者不建议压力治疗作为初始治疗1B9.3建议压力治疗促进溃疡愈合2B9.4建议压力治疗辅助手术治疗预防溃疡复发1AClinical practice guidelines of the Society for Vascular Surgery and the American Venous Forum 2011Glov

15、iczki P,et al.J Vasc Surg. 2011 May;53(5 Suppl)2S-48S. 治疗手术治疗GRADE of recommendationLevel of evidence10.1对于大隐静脉曲张，建议至膝水平高位结扎、剥脱2B10.4未预防溃疡复发，建议压力治疗结合手术1A10.7建议剥除隐静脉的同时剥除曲张静脉1B硬化剂治疗12.1硬化剂治疗更推荐用于网状静脉曲张、毛细血管扩张症和曲张静脉.1B2011版 美国血管外科协会&美国静脉论坛 治疗Clinical practice guidelines of the Society for Vascular Sur

16、gery and the American Venous Forum 2011Gloviczki P,et al.J Vasc Surg. 2011 May;53(5 Suppl)2S-48S.2011版 美国血管外科协会&美国静脉论坛临床实践指南推荐射频消融用于CVI治疗推荐等级高于开放性手术治疗11. Endovenous thermal ablation 腔内热消融GRADE of recommendationLevel of evidence11.1腔内热消融安全有效(laser and radiofrequency ablations)1B11.2相对于开放手术，因痛苦少，并发症低，

17、更推荐腔内热消融1B12.2对于隐静脉功能不全，更推荐腔内热消融超过泡沫硬化剂治疗1BClinical practice guidelines of the Society for Vascular Surgery and the American Venous Forum 2011Gloviczki P,et al.J Vasc Surg. 2011 May;53(5 Suppl)2S-48S. 治疗年英国国家临床规范研究院 （NICE）National Institute of Clinical Excellence As interventions for VV and truncal

18、reflux, the following treatment hierarchyis recommended:1.Endothermal ablation UGFS surgery,2.Compression hosiery shouldonly be considered as a treatment option if interventional therapy not suitable.对于曲张静脉以及主干返流，推荐使用下列治疗方法：1.腔内热消融 超声引导下硬化剂治疗 外科手术2.只有当上述方法不合适时，才考虑使用弹力袜加压治疗Varicose veins in the legs:

19、 the diagnosis and management of varicose veins InternetLondon: National Institute for Health and Care Excellence (UK); 2013 Jul. cited 2015 Jan19. (NICE clinical guideline) 治疗2012年ETAV大会和2015年ESVS指南共同推荐腔内热消融治疗CVIPavlovi MD,et al.Phlebology. 2015 May;30(4)257-73.Wittens C,et al.Eur J Vasc Endovasc S

20、urg. 2015 Jun;49(6):678-737. 2015欧洲血管外科协会临床实践指南推荐腔内热消融治疗大隐静脉反流大隐静脉反流伴慢性静脉疾病患者推荐腔内热消融治疗(1A)，推荐等级优于开放性手术和泡沫硬化治疗2012年ETAV大会实行腔内热消融需进行术前、术后诊断ETA治疗大隐静脉(1A) 治疗231.流行病学2.病因及病理生理3.诊断及临床分级4.治疗5.国外文献及本中心经验 内容大纲各项临床研究得到的RFA12-24个月的随访后大隐静脉闭合率为95%左右1-4与激光消融相比，射频消融术后疼痛和并发症的发生率较低1,3与传统手术相比，射频消融术手术时间长，但术后恢复时间大大短于传统

21、手术41.Ann Surg. 2011 Dec;254(6):876-81. doi: 10.1097/SLA.0b013e318230af5a.A prospective double-blind randomized controlled trial of radiofrequency versus laser treatment of the great saphenous vein in patients with varicose veins.Nordon IM1, Hinchliffe RJ, Brar R, Moxey P, Black SA, Thompson MM, Loft

22、us IM.2. Angiology. 2011 Jan;62(1):49-54. doi: 10.1177/0003319710380680. Epub 2010 Aug 18.Great saphenous vein radiofrequency ablation versus standard stripping in the management of primary varicose veins-a randomized clinical trial.Helmy ElKaffas K1, ElKashef O, ElBaz W.3. Eur J Vasc Endovasc Surg.

23、 2010 Aug;40(2):246-53. doi: 10.1016/j.ejvs.2010.02.026.Laser and radiofrequency ablation study (LARA study): a randomised study comparing radiofrequency ablation and endovenous laser ablation (810 nm).Goode SD1, Chowdhury A, Crockett M, Beech A, Simpson R, Richards T, Braithwaite BD.4. Br J Surg. 2

24、010 Mar;97(3):328-36. doi: 10.1002/bjs.6867.Randomized clinical trial of radiofrequency ablation or conventional high ligation and stripping for great saphenous varicose veins.Subramonia S1, Lees T.1.Ann Surg. 2011 Dec;254(6):876-81. doi: 10.1097/SLA.0b013e318230af5a.A prospective double-blind rando

25、mized controlled trial of radiofrequency versus laser treatment of the great saphenous vein in patients with varicose veins.Nordon IM1, Hinchliffe RJ, Brar R, Moxey P, Black SA, Thompson MM, Loftus IM.2. Angiology. 2011 Jan;62(1):49-54. doi: 10.1177/0003319710380680. Epub 2010 Aug 18.Great saphenous

26、 vein radiofrequency ablation versus standard stripping in the management of primary varicose veins-a randomized clinical trial.Helmy ElKaffas K1, ElKashef O, ElBaz W.3. Eur J Vasc Endovasc Surg. 2010 Aug;40(2):246-53. doi: 10.1016/j.ejvs.2010.02.026.Laser and radiofrequency ablation study (LARA stu

27、dy): a randomised study comparing radiofrequency ablation and endovenous laser ablation (810 nm).Goode SD1, Chowdhury A, Crockett M, Beech A, Simpson R, Richards T, Braithwaite BD.4. Br J Surg. 2010 Mar;97(3):328-36. doi: 10.1002/bjs.6867.Randomized clinical trial of radiofrequency ablation or conve

28、ntional high ligation and stripping for great saphenous varicose veins.Subramonia S1, Lees T. 国外文献使用ClosureFast导管*进行腔内RFA：5年数据Dietzek A. RF Segmental ablation: 5-year data. Annual Symposium on Vascular and Endovascular Issues, Techniques, Horizons (Veith Symposium) New York City; November 19, 20131年

29、2年3年4年5年静脉闭塞96.6%94.3%92.8%91.1%90.0%96.6%90.0%治疗后天数累积闭塞率 国外文献并发症发生率并发症1周(N=395)3月(N=371)1年(N=350)5年(N=279)瘀斑5.8%0.0%0.0%0.0%红疹1.3%0.0%0.0%0.0%血肿1.0%0.3%0.0%0.0%感染0.0%0.0%0.0%0.0%疼痛1.8%0.0%0.6%0.0%感觉异常1.5%2.4%0.3%0.7%Dietzek A. RF Segmental ablation: 5-year data. Annual Symposium on Vascular and End

30、ovascular Issues, Techniques, Horizons (Veith Symposium) New York City; November 19, 2013 国外文献 Recovery研究：激光消融 VS ClosureFastAlmeida JI,et al.J Vasc Interv Radiol. 2009 Jun;20(6)752-759.*术后48小时，1周，2周，1个月的状况进行评估美国5个研究中心、欧洲7个研究中心前瞻性、多中心、单盲、随机对照试验共纳入69名患者(87条患肢)随机接受激光消融(n=41)或ClosureFast(n=46)主要终点：术后疼痛

31、、瘀斑、肢体柔弱无力、术后后遗症次要终点：VCSS、QOF* 国外文献Recovery研究：ClosureFast组：术后疼痛、瘀伤、压痛更低随访疼痛评分(分数：010)更少疼痛更少瘀伤更少压痛瘀斑患者术后中度到重度瘀斑(擦伤)的百分比压痛评分(分数：010)P 0.0001P 0.0001P 0.0001NSP = 0.0048P = 0.0036P = 0.0005NSP 0.00012天7天14天30天2天7天14天30天Almeida JI,et al.J Vasc Interv Radiol. 2009 Jun;20(6)752-759. 国外文献Recovery研究：Closure

32、Fast组：术后并发症更少，VCSS评分更低，QOF更高激光 (N = 41)CLF(N = 46)静脉炎6 (14.6)0红疹4 (9.8%)0感觉异常2 (4.9)1(2.2%)血栓扩展/ DVT1 (2.4%)0色素沉着01(2.2%)感染00肢体 w/ 后遗症*9* (22%)2(4.4%)术后并发症较少P = 0.0009P = 0.0002P = 0.0035NSNS生活质量评分: 全部注解: 分值越低对应的 QOL更高较快提高善生活质量P = 0.03P 0.001P = 0.003NSNS静脉功能不全症状严重度评分标准 (VCSS)*p=0.021*14例激光治疗中有9例出现后遗症.Almeida JI,et al.J Vasc Interv Radiol. 2009 Jun;20(6)752-759. 国外文献Rasmussen 研究：射频消融、激光消融、泡