射頻閉合術(shù)國外文獻(xiàn)及指南解讀課件

1、靜脈射頻術(shù)國外文獻(xiàn)及指南解讀21.流行病學(xué)2.病因及病理生理3.診斷及臨床分級(jí)4.治療5.國外文獻(xiàn)及本中心經(jīng)驗(yàn) 內(nèi)容大綱 流行病學(xué)全球患慢性靜脈功能不全(CVI)或靜脈曲張的患者超過1億9000萬人美國患病率約23%男性：1100萬女性：2200萬患者年齡40-80歲僅190萬患者尋求治療我國靜脈曲張患者約1億以上，發(fā)病率為15%左右3歐洲發(fā)病率為20%-50%其中英國占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. 劉凱,等.血管與腔內(nèi)血管外科雜志.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. 影響所有年齡的人群1患病率是PAD的10倍1美國每年CVI的直接花費(fèi)預(yù)計(jì)為1億5千萬到10億美元2住院患者CVI平均發(fā)病率為92/100,0003每年至少有20,556名患者被確診為靜脈性潰瘍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. 流行病學(xué)超過3千萬美國

5、人患有靜脈曲張或慢性靜脈疾病(CVI)(一種更嚴(yán)重的靜脈疾病)1在這3千多萬美國人中：僅有190萬每年會(huì)尋求治療1,2絕大多數(shù)仍未確診或未接受治療CVI患病率1,2*30,000,000尋求治療*21,900,000接受治療447,0002*統(tǒng)計(jì)數(shù)據(jù)來源于40歲以上的個(gè)體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. 流行病學(xué)61.流行病學(xué)2.病因及病理生理3.診斷及臨床分級(jí)4.治療5.國外文獻(xiàn)及本中心經(jīng)驗(yàn) 內(nèi)容大綱風(fēng)險(xiǎn)因素其他可能性風(fēng)險(xiǎn)因素*高齡家族史DVT肥胖久立妊娠女性吸煙高血壓口服避孕藥或激素替代治療體力活動(dòng)便秘*不同研究結(jié)果存在差

7、異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靜脈曲張靜脈小腿肌肉收縮迫使靜脈血流向心臟靜脈功能正常的小腿肌肉泵一次肌肉收縮可以排空40%-60%的血液步行7-12步=靜脈壓從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發(fā)生/發(fā)展圖片由Dr. Labropoulos提供下肢任意淺靜脈或深靜脈都可能發(fā)生主靜脈反流，但是前者更頻繁隱靜脈及其支靜脈擴(kuò)張或曲張通常無明顯癥狀Labropoulos N, et al. J Vasc Surg. 2010;51:96-103 . 瘤樣擴(kuò)張 病因及病理生理101.流行病學(xué)2.病因及病理生理3.診斷及臨床分級(jí)4.治療5.國外文獻(xiàn)及本中心經(jīng)驗(yàn) 內(nèi)容大綱2022/7/27111.體格檢查GRADE of recommendationLevel of evidence1.1對(duì)于CVD患者建議完善視診、觸診及聽診檢查，

9、并詳細(xì)詢問患者癥狀1A2.多普勒超聲2.1對(duì)于CVD患者建議超聲輔助體格檢查及問診1A3.體積描記法3.2對(duì)于超聲無法明確病因的嚴(yán)重CVD（C3-C6）建議容積描記法檢查1B2011版 美國血管外科協(xié)會(huì)&美國靜脈論壇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. 診斷及臨床分級(jí)2022/7/27122011版 美國血管外科協(xié)會(huì)&美

10、國靜脈論壇6分級(jí)GRADE of recommendationLevel of evidence6.1建議CEAP分級(jí)作為靜脈曲張疾病臨床分級(jí)。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. 診斷及臨床分級(jí)CEAP(臨床/病因?qū)W/解剖學(xué)/病理生理學(xué))C級(jí)C0靜脈疾病沒有可見的或明顯指征C1毛細(xì)血管擴(kuò)張或蛛狀靜脈C2靜脈曲張C3

11、水腫C4a色素沉著和/或濕疹C4b脂性硬皮病和/或白色萎縮C5愈合性靜脈潰瘍C6活動(dòng)性靜脈潰瘍C1毛細(xì)血管擴(kuò)張或網(wǎng)狀靜脈C2靜脈曲張C3水腫圖片由 Jennifer A. Heller, MD提供CEAP(臨床/病因?qū)W/解剖學(xué)/病理生理學(xué))C級(jí)圖片由 Gordon Gibbs, M.D. 和Jennifer A. Heller, MD提供C4a:色素沉著或濕疹C4b:脂性硬皮病或白色萎縮C5:愈合性靜脈潰瘍C6:活動(dòng)性靜脈潰瘍CEAP(臨床/病因?qū)W/解剖學(xué)/病理生理學(xué))C級(jí)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(臨床/病因?qū)W/解剖學(xué)/病理生理學(xué))級(jí)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.流行病學(xué)2.病因及病理生理3.診斷及臨床分級(jí)4.治療5.國外文獻(xiàn)及本中心經(jīng)驗(yàn) 內(nèi)容大綱2011版 美國血管外科協(xié)會(huì)&美國靜脈論壇藥物治療GRADE of recommendat

14、ionLevel of evidence8.1對(duì)于CVD導(dǎo)致下肢腫脹、疼痛患者建議使用靜脈活性藥物治療2B8.2對(duì)于潰瘍患者建議已酮可可堿或微?；S酮配合彈力襪促進(jìn)愈合2B壓力治療9.1對(duì)于癥狀性靜脈曲張患者建議中等壓力（20-30mmHg）治療2C9.2對(duì)于預(yù)計(jì)接受靜脈曲張手術(shù)患者不建議壓力治療作為初始治療1B9.3建議壓力治療促進(jìn)潰瘍愈合2B9.4建議壓力治療輔助手術(shù)治療預(yù)防潰瘍復(fù)發(fā)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. 治療手術(shù)治療GRADE of recommendationLevel of evidence10.1對(duì)于大隱靜脈曲張，建議至膝水平高位結(jié)扎、剝脫2B10.4未預(yù)防潰瘍復(fù)發(fā)，建議壓力治療結(jié)合手術(shù)1A10.7建議剝除隱靜脈的同時(shí)剝除曲張靜脈1B硬化劑治療12.1硬化劑治療更推薦用于網(wǎng)狀靜脈曲張、毛細(xì)血管擴(kuò)張癥和曲張靜脈.1B2011版 美國血管外科協(xié)會(huì)&美國靜脈論壇 治療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 美國血管外科協(xié)會(huì)&美國靜脈論壇臨床實(shí)踐指南推薦射頻消融用于CVI治療推薦等級(jí)高于開放性手術(shù)治療11. Endovenous thermal ablation 腔內(nèi)熱消融GRADE of recommendationLevel of evidence11.1腔內(nèi)熱消融安全有效(laser and radiofrequency ablations)1B11.2相對(duì)于開放手術(shù)，因痛苦少，并發(fā)癥低，

17、更推薦腔內(nèi)熱消融1B12.2對(duì)于隱靜脈功能不全，更推薦腔內(nèi)熱消融超過泡沫硬化劑治療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. 治療年英國國家臨床規(guī)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.對(duì)于曲張靜脈以及主干返流，推薦使用下列治療方法：1.腔內(nèi)熱消融 超聲引導(dǎo)下硬化劑治療 外科手術(shù)2.只有當(dāng)上述方法不合適時(shí)，才考慮使用彈力襪加壓治療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) 治療2012年ETAV大會(huì)和2015年ESVS指南共同推薦腔內(nèi)熱消融治療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歐洲血管外科協(xié)會(huì)臨床實(shí)踐指南推薦腔內(nèi)熱消融治療大隱靜脈反流大隱靜脈反流伴慢性靜脈疾病患者推薦腔內(nèi)熱消融治療(1A)，推薦等級(jí)優(yōu)于開放性手術(shù)和泡沫硬化治療2012年ETAV大會(huì)實(shí)行腔內(nèi)熱消融需進(jìn)行術(shù)前、術(shù)后診斷ETA治療大隱靜脈(1A) 治療231.流行病學(xué)2.病因及病理生理3.診斷及臨床分級(jí)4.治療5.國外文獻(xiàn)及本中心經(jīng)驗(yàn) 內(nèi)容大綱各項(xiàng)臨床研究得到的RFA12-24個(gè)月的隨訪后大隱靜脈閉合率為95%左右1-4與激光消融相比，射頻消融術(shù)后疼痛和并發(fā)癥的發(fā)生率較低1,3與傳統(tǒng)手術(shù)相比，射頻消融術(shù)手術(shù)時(shí)間長，但術(shù)后恢復(fù)時(shí)間大大短于傳統(tǒng)

21、手術(shù)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. 國外文獻(xiàn)使用ClosureFast導(dǎo)管*進(jìn)行腔內(nèi)RFA：5年數(shù)據(jù)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年靜脈閉塞96.6%94.3%92.8%91.1%90.0%96.6%90.0%治療后天數(shù)累積閉塞率 國外文獻(xiàn)并發(fā)癥發(fā)生率并發(fā)癥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%紅疹1.3%0.0%0.0%0.0%血腫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%感覺異常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 國外文獻(xiàn) Recovery研究：激光消融 VS ClosureFastAlmeida JI,et al.J Vasc Interv Radiol. 2009 Jun;20(6)752-759.*術(shù)后48小時(shí)，1周，2周，1個(gè)月的狀況進(jìn)行評(píng)估美國5個(gè)研究中心、歐洲7個(gè)研究中心前瞻性、多中心、單盲、隨機(jī)對(duì)照試驗(yàn)共納入69名患者(87條患肢)隨機(jī)接受激光消融(n=41)或ClosureFast(n=46)主要終點(diǎn)：術(shù)后疼痛

31、、瘀斑、肢體柔弱無力、術(shù)后后遺癥次要終點(diǎn)：VCSS、QOF* 國外文獻(xiàn)Recovery研究：ClosureFast組：術(shù)后疼痛、瘀傷、壓痛更低隨訪疼痛評(píng)分(分?jǐn)?shù)：010)更少疼痛更少瘀傷更少壓痛瘀斑患者術(shù)后中度到重度瘀斑(擦傷)的百分比壓痛評(píng)分(分?jǐn)?shù)：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. 國外文獻(xiàn)Recovery研究：Closure

32、Fast組：術(shù)后并發(fā)癥更少，VCSS評(píng)分更低，QOF更高激光 (N = 41)CLF(N = 46)靜脈炎6 (14.6)0紅疹4 (9.8%)0感覺異常2 (4.9)1(2.2%)血栓擴(kuò)展/ DVT1 (2.4%)0色素沉著01(2.2%)感染00肢體 w/ 后遺癥*9* (22%)2(4.4%)術(shù)后并發(fā)癥較少P = 0.0009P = 0.0002P = 0.0035NSNS生活質(zhì)量評(píng)分: 全部注解: 分值越低對(duì)應(yīng)的 QOL更高較快提高善生活質(zhì)量P = 0.03P 0.001P = 0.003NSNS靜脈功能不全癥狀嚴(yán)重度評(píng)分標(biāo)準(zhǔn) (VCSS)*p=0.021*14例激光治療中有9例出現(xiàn)后遺癥.Almeida JI,et al.J Vasc Interv Radiol. 2009 Jun;20(6)752-759. 國外文獻(xiàn)Rasmussen 研究：射頻消融、激光消融、泡