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1 대한혈관외과학회지 : 제 25 권제 2 호 Vol. 25, No. 2, November 2009 최신 VNUS ClosureFAST System 을이용한정맥내고주파열제거술과평면고위결찰술을병행한하지정맥류의조기결과 대구보훈병원흉부외과 1, 안동병원흉부외과 2 공준혁 1 ㆍ허진 2 The Early Results of Endovenous Radiofrequency Ablation Combined with Flush High Ligation for Patients with Varicose Veins Joon Hyuk Kong, M.D. 1 and Jin Hur, M.D. 2 Department of Thoracic and Cardiovascular Surgery, Daegu Veterans Hospital 1, Daegu, and Andong Hospital 2, Andong, Korea Purpose: Radiofrequency ablation of the great saphenous vein has proven efficacy with an excellent side effect profile, but it has the disadvantage of a lengthy pullback procedure. A new generation catheter (ClosureFast) was recently introduced to address the aforementioned procedural speed and the ease of use issues with using the principles of the segmental ablation technique. This study is done to report the early results after radiofrequency ablation with high ligation and using the ClosureFast catheter. Methods: One hundred and nineteen limbs in 85 patients with great saphenous vein incompetence were treated between November, 2007 and June, 2009 with radiofrequency ablation with high ligation, and usually with adjunctive stab-avulsion phlebectomies. The patients were examined preoperatively and at 1 to 2 months postoperatively by using duplex sonography to determine the treatment s efficacy, as well as the adverse sequalae. Results: The patients had an average age of 61.3±10.1 years (range, 32 to 80 years), and 22 (25.9%) were women. The pretreatment vein diameter measured in the supine position ranged from 5.0 to 20.0 mm (median, 8.5 mm). The total average operation time of the radiofrequency ablation with high ligation, except when performing phlebectomies, was 18.5±9.5 minutes. Serious complications such as deep vein thrombosis or neural injury were not observed. Paresthesia occurred in 7 limbs (5.8%). A thermal skin injury and thrombophlebitis were presented in one limb each, respectively, at the beginning period. The occlusion rate was 98.9% in 98 limbs on the follow-up at 1 to 2 months. Conclusion: Radiofrequency ablation with high ligation is feasible, safe and effective. However, long-term follow-up is needed in the future. Key Words: Radiofrequency ablation, Varicose veins, High ligation 중심단어 : 고주파열제거술, 하지정맥류, 고위결찰술 서 론 접수일 : 2009 년 9 월 30 일, 승인일 : 2009 년 11 월 11 일책임저자 : 공준혁, 대구시달서구월곡로 565 우 , 대구보훈병원흉부외과 Tel: Fax: joonhyukkong@empal.com 이논문은 2009 ASVS 및 2009 ATCSA 에 poster 로발표됨. 복재-대퇴정맥접합부 (saphenofemoral junction, SFJ) 와대복재정맥 (great saphenous vein, GSV) 의역류로발생한하지정맥류의치료를위해서는역류된정맥의최상부병변을우선치료하여야하며, 이와더불어기능부전을보이는정맥분절을제거하는것이수술적치료의표준 146

2 Joon Hyuk Kong and Jin Hur:Radiofrequency Ablation Combined with Flush High Ligation 147 방식으로알려져왔다. 그리고, 최근에는최소침습적치료 (minimal invasive treatment) 방법에대한환자의요구가증가되고있어혈관내레이저시술 (endovenous laser), 고주파열제거술 (radiofrequency ablation), 광투시전동형정맥제거술 (tranilluminated powered phlebectomy, TIPP) 등이시행되고있다 (1-3). 대복재정맥의치료에있어기존의정맥내고주파열제거술 (endovenous radiofrequency ablation) 은회복이빠르고, 술후통증이적은것으로알려져있었으나긴시술시간이단점이었다. 저자는최근개발된 2세대 ClosureFAST 카테터와 RFGPlus TM Generator로구성된 Closure system (VNUS Medical Technologies, San Jose, CA, USA) 을이용한고주파열제거술과평면고위결찰술 (flush high ligation) 로하지정맥류수술을시행하여그조기결과를보고하는바이다. 방법 1) 대상및술전진단 2007년 11월부터 2009년 6월까지대복재정맥역류로인한하지정맥류환자 119예 (85명) 을대상으로서혜부최소절개를이용한고위결찰술과고주파열제거술을시행하였다. 수술전초음파를실시하여복재-대퇴정맥접합부와대복재정맥의역류를진단하고, 심부정맥혈전증등의금기사항이없는경우에시행하였다. 이전대복재정맥의치료병력이있거나소복재정맥역류가더심한경우는연구대상에서제외하였고술전환자의동반질환, 증상여부및대복재정맥의최대직경을조사하였다. 2) 수술방법기립상태에서충분히정맥류가노출되도록하고사진을촬영후정맥류부위에유성펜으로표시하였다. 마취는척추마취를기본으로하였다. 수술중환자의의식이깨어있는상태이므로환자와충분한대화를나누어긴장을풀어주기위해배려하였으며, 필요시에는 midazolam 등의정맥마취제도주입하였다. 앙아위에서서혜부에 1.5 cm 정도의횡절개를가한후복재정맥이대퇴정맥으로유입되는복재-대퇴정맥접합부를확인하고, 주위조직손상을최소화하며주의깊게박리하여복재정맥으로유입되는모든분지들을결찰및분리하였다. 대복재정맥발거술 (stripping) 을시행시에는발거술시행후발생하는대퇴부내측의혈종을방지하기위해복재- 대퇴정맥접합부의 5 10 cm 하방에서분지하는내측및외측부복재정맥을결찰하는경우도있다. 하지만, 저자는대퇴부의대복재정맥은정맥내시술을시행하므로내측및외측부복재정맥의결찰은시행하지않았다. 이후대퇴정맥의협착방지및대복재정맥결찰기부에발생할수있는혈전형성을방지하기위하여반드시평 면고위결찰술을시행하였다. 고주파열제거술을시행하기위해술중접근성이용이한발목부근처대복재정맥를육안으로확인하고경피적접근으로유도초를삽입하였다. 18 게이지혈관주사침으로정맥접근부위에천자하고 0.035인치유도와이어를삽입후 18 게이지혈관주사침을제거하고가이드와이어에 7 Fr 유도초를삽입하였다. 발목부에서서혜부까지카테터를삽입하여야하므로, 60 cm (CF7-7-60) 과 100 cm (CF ) 길이의 ClosureFAST catheter 중 100 cm (CF ) 길이를사용하였다. 7 Fr 유도초 (introducer) 내 7 Fr 고주파카테터 (ClosureFAST catheter) 를삽입하여카테터의끝을손으로촉진하면서, 카테터가대복재정맥의주행방향대로이동하는지확인하였다. 카테터끝이서혜부의결찰된대복재정맥부위에닿으면더이상밀어넣지않았다. 대복재정맥주위로무릎상방부위까지국소침윤마취법 (tumescent fluid infiltration) 을시행하였다. 0.1% 국소침윤마취용액 (tumescent local anesthesia, TLA) 을정맥 1 cm 당약 10 cc사용하였는데, 국소침윤마취법은혈관주변마취뿐만아니라신경이나동맥등혈관주변조직을보호하는열흡수원의작용과정맥혈관을압박하는작용도있어안전하고효율적으로고주파에너지의혈관전달을가능하게한다. 적절한정맥압박을위해부종유도액 (tumescent fluid), Trendelenburg 자세및외부압박을이용하였다. 외부압박은손가락이나손바닥을이용한수기압박을시행하였고, 초음파유도시에는초음파소식자를이용하여압박할수있다. 카테터를대복재정맥내최상부에거치시키고고주파열제거술을실시하였다. 20초동안 120 o C의온도를발생시키면, 이전도열로정맥에는 o C의온도가가해진다. 이후카테터를 6.5 cm 간격으로하방으로후퇴시켜 0.5 cm의중복구역 (overlap zone) 을형성한다. 분절제거술 (segmental ablation) 은시술속도를향상시켜 45 cm 정맥인경우 3 5분정도의시간이소비되었다. 무릎이하부위의정맥류는다발성정맥류제거술을시행하였다. 수술후거즈를댄후압박드레싱을하고수술을마쳤다. 대부분수술다음날붕대를제거하고정맥류치료용압박스타킹을착용시켰다. 3) 술후평가수술시동반수술여부, 술후합병증여부그리고술후 1 2개월에대복재정맥의재관류여부를초음파로확인하여치료성공률을알아보았다. 결과 1) 대상환자의임상적특성하지정맥류환자 85명을대상으로 119예에서서혜부

3 148 대한혈관외과학회지 : 제 25 권제 2 호 2009 Table 1. Comordibity of patients (n=85) Disease entity No. of patients (%) Hypertension 18 (21.1%) Diabetes mellitus 13 (15.3%) Cardiac disease 8 (9.4%) Arthritis 7 (8.2%) Peripheral artery disease 2 (2.3%) Severe obesity 2 (2.3%) Thyroid disease 1 (1.1%) Table 2. Preoperative symptoms of each leg (n=119) Symptoms No. of limbs (%) None 31 (26.1%) Symptoms 88 (73.9%) Fatigue 65 (54.6%) Pain 9 (7.7%) Edema 3 (2.5%) Tingling sensation 2 (1.7%) Etc 9 (7.7%) 최소절개를이용한고위결찰술을동반한고주파열제거술을시행하였다. 술전환자의평균연령은 61.3±10.1 (32 80) 세였으며, 남자가 63명 (74.1%) 이었다. 환자의동반질환으로는고혈압과당뇨가각각18명 (21.1%), 13명 (15.3%) 으로가장많았다 (Table 1). 시술전증상으로는대부분이저녁에심해지는피로감과통증을가장많이호소하였으며, 미용상의문제로방문한경우도 31예 (26.1%) 가있었다 (Table 2). 2) 수술결과 술전초음파상대복재정맥최대직경은 5 20 mm (median 8.5 mm) 이었으며, 양측대복재정맥을모두시행한경우가 34명 (40%) 이었다. 한측만시행한경우는 51 명 (60.0%) 이었으며이중반대편소복재정맥의결찰및분리술이 13명, 대복재정맥발거술을시행한경우가 6명이었다. 반대편대복재정맥을발거한경우는대복재정맥이심하게꼬여있는경우와맥류 (aneurysm) 를형성한경우이었다. 고주파열제거술및고위결찰술의평균시술시간은 18.5±9.5분이었다 (Table 3). 술후합병증으로 7예 (5.8%) 에서감각이상이발생하였으며, 시술초기에한환자에서정맥염과피부화상이발생하였다. 그외혈종, 심부정맥혈전, 신경손상은관찰되지않았다 (Table 4). 술후 1 2개월에추적관찰이가 Parameters Table 3. Perioperative data Data Maximum diameter of GSV 5 20 (median 8.5 mm) Operation time 18.5±9.5 mins Bilateral GSV VNUS 34 patients (40.0%) Unilateral GSV VNUS 51 patients (60.0%) Contralateral SSV operation: 13 patients* Contralateral GSV stripper stripping: 6 patients* GSV = great saphenous vein; SSV = small saphenous vein; RFA = radiofrequency ablation; * = in uninlateral GSV VNUS cases. Table 4. Complications (n=119) Complications No. of limbs (%) Paresthesia 7/119 (5.0%) Vasculitis 1/119 (0.8%) Skin burn 1*/119 (0.8%) Hem otoma 0 Deep vein thrombosis 0 Nerve injury 0 *The same patient of vasculitis. 능한 98예에서실시한초음파상치료성공률은 98.9% 이었다. 고 2극전극 (bipolar electrode) 으로구성된 1세대카테터인 ClosurePlus catheter를이용하는경우에는시술대상길이만큼카테터를정해진속도로후퇴 (pullback) 하므로시간이길어진다는단점과고임피던스 (high impedance) 로인한차단 (shut-off) 이종종발생하는단점이있었다. 하지만, 최근개발된 2세대카테터인 ClosureFAST catheter 및Radiofrequency generator인 RFGPlus TM Generator를이용한표준기법 (standard technique) 의경우, 7 cm 길이의발열코일 (7 cm-long heating element coil) 을사용하여분절제거술을시행하므로시술시간을단축시킬수있다는장점과 RFGPlus TM Generator의기능중하나인온도되먹임회로 (temperature feedback loop) 을이용하여시술을용이하게할수있다는장점이있다 (Fig. 1, 2). 그리고, 최근에는정맥내치료를시행하더라도, 복재-대퇴정맥접합부에서의재발을보다줄이기위해고위결찰술을동시에시행한보고가있다 (4). 이에저자는고주파열제거술과고위결찰술을시행하는것을원칙으로하였다. 찰

Segmental ablation: Closure- FAST utilizes radiofrequency energy to power a heating element that conductively

5 cm treatment overlap zone. This segmental technique significantly increases the procedure speed. Fig. 2.

4 Joon Hyuk Kong and Jin Hur:Radiofrequency Ablation Combined with Flush High Ligation 149 Fig. 1. Segmental ablation: Closure- FAST utilizes radiofrequency energy to power a heating element that conductively heats the vein wall. The catheter is then moved distally in 6.5 cm increments, thus achieving a 0.5 cm treatment overlap zone. This segmental technique significantly increases the procedure speed. Fig. 2. RFGPlus TM Generator messages and alerts: The RFGPlus generator monitors impedance but does not display. Instead, when less than optimal exsanguination or compression is detected, a warning or an advisory message is displayed, prompting technical correction.

5 150 대한혈관외과학회지 : 제 25 권제 2 호 2009 표준기법에서는복재-대퇴정맥접합부를고주파열제거술로치료한다. 초음파유도하에카테터팁의위치를상복부정맥의직하방이나복재-대퇴정맥접합부에서 cm 떨어진곳에위치시키고, 초음파유도하복재-대퇴정맥주위에부종유도액 (tumescent solution) 을주입하여고주파열제거술을 2회시행한다. 하지만, 저자는정맥혈역류의완벽한제거를위해복재-대퇴정맥접합부의고위결찰술과주위분지결찰및분리를시행하였다. 복재 -대퇴퇴정맥접합부위에서분지되는모든분지를결찰및분리한후, 술후대퇴정맥협착방지및대복재정맥결찰기부에발생할수있는혈전형성을방지하기위하여반드시평면고위결찰술을시행하는것을원칙으로치료하였다. 복재-대퇴정맥접합부와대복재정맥의역류로발생한하지정맥류의치료를위해서는역류된정맥의최상부를우선치료하여야하며, 이와더불어기능부전을보이는정맥분절을제거하는것이수술적치료의표준방식으로알려져왔다. 그러나근래고위결찰술후발생하는신생혈관에의한하지정맥류의재발이거론되면서과연하지정맥류의치료로고식적인고위결찰술이반드시필요한가에대한논란이있어왔다 (5). 하지만, 아직이문제는완전히해결되지못하고있으며장기적으로면밀한연구가필요한실정이다. 저자의지난 3년간경험에서는아직신생혈관에의한서혜부정맥류의의미있는재발을관찰할수없었다. 재발은임상적재발과혈류역학적재발로구분할수있으며, 전자는일반적으로표현하는재발이며후자는복재-대퇴정맥접합부의역류가관찰되는경우이다 (6). 임상적인재발률은첫수술시의완벽함과검사자의주관등에의해영향을받을수있으며, 혈류역학적재발률은다소객관적인자료로이에대해서는많은보고가있다 (7-12). Fisher 등 (13) 은고위결찰술과주위분지결찰및분리를시행하고평균 34년추적관찰한 125 다리에서접합부및주위접합부연결을 64% 에서발견하였다고한다. 고주파열제거술개발초기에는대복재정맥의직경이비교적크지않은경우에시술을하였으나 (1), 최근에는시술경험이쌓이면서효과적인혈관의눌림과카테터정맥벽접촉이가능하여대복재정맥의직경이 mm까지에도시행하고있다 (14,15). 하지만고위결찰술을동시에시행시는이보다직경이큰대복재정맥인경우에서도적용될수있다는장점이있다. 표준기법에서는정맥접근시초음파유도하무릎상방 ( 대퇴부하방 ) 이나무릎하방의대복재정맥에카테터를삽입하나, 저자는술중접근성이용이한발목부근처대복재정맥에육안으로카테터를삽입하였다. 7 Fr 유도초를삽입하므로정맥접근부위외부상처가작지는않아표준기법시술시술후에는환자가반바지착 용시상처부위가두드러질수있다. 하지만, 발목부근처에정맥접근을하면, 술후환자가양말착용만으로상처부위가쉽게가려질수있는장점이있다. 그리고대퇴부하방의대복재정맥까지고주파열제거술을시행하려면, 표준기법에서는대상대복재정맥내유도초가거치되어있을경우유도초의후퇴가필요하나변형기법에서는대퇴부하방에유도초가없으므로용이하게시행할수있는장점도있다. 결 ClosureFAST 카테터와 RFGPlus TM Generator로구성된 Closure system을이용한고주파열제거술과평면고위결찰술은대복재정맥정맥류를안전하고효과적으로치료하는방법으로, 본연구는단기간의연구결과로향후더큰모집단을대상으로장기적인추적관찰이필요하며, 궁극적으로완전하고지속적인대복재정맥폐쇄를위한연구에도움이되었으면한다. 론 REFERENCES 1) Puggioni A, Kalra M, Carmo M, Mozes G, Gloviczki P. Endovenous laser therapy and radiofrequency ablation of the great saphenous vein: analysis of early efficacy and complications. J Vasc Surg 2005;42: ) Schmedt CG, Sroka R, Steckmeier S, Meissner OA, Babaryka G, Hunger K, et al. Investigation on radiofrequency and laser (980 nm) effects after endoluminal treatment of saphenous vein insufficiency in an ex-vivo model. Eur J Vasc Endovasc Surg 2006;32: ) Rasmussen LH, Bjoern L, Lawaetz M, Blemings A, Lawaetz B, Eklof B. Randomized trial comparing endovenous laser ablation of the great saphenous vein with high ligation and stripping in patients with varicose veins: short-term results. J Vasc Surg 2007;46: ) Kalteis M, Berger I, Messie-Werndl S, Pistrich R, Schimetta W, Polz W, et al. High ligation combined with stripping and endovenous laser ablation of the great saphenous vein: early results of a randomized controlled study. J Vasc Surg 2008; 47: ) Hur S. Topic I: Great saphenous vein, high ligation and stripping. In: Proceedings of the 14th the Autumn Conference of the Korean Society of Phlebology; 2007 Nov 11; Seoul, Korea: The Korean Society of Phlebology; p ) Dietzek AM. Endovenous radiofrequency ablation for the treatment of varicose veins. Vascular 2007;15: ) Dwerryhouse S, Davies B, Harradine K, Earnshaw JJ. Stripping the long saphenous vein reduces the rate of reoperation for recurrent varicose veins: five-year results of a randomized trial. J Vasc Surg 1999;29:

6 Joon Hyuk Kong and Jin Hur:Radiofrequency Ablation Combined with Flush High Ligation 151 8) Rutgers PH, Kitslaar PJ. Randomized trial of stripping versus high ligation combined with sclerotherapy in the treatment of the incompetent greater saphenous vein. Am J Surg 1994; 168: ) Neglen P, Einarsson E, Eklof B. The functional long-term value of different types of treatment for saphenous vein incompetence. J Cardiovasc Surg (Torino) 1993;34: ) Munn SR, Morton JB, Macbeth WA, McLeish AR. To strip or not to strip the long saphenous vein? A varicose veins trial. Br J Surg 1981;68: ) Hammarsten J, Pedersen P, Cederlund CG, Campanello M. Long saphenous vein saving surgery for varicose veins. A long-term follow-up. Eur J Vasc Surg 1990;4: ) Jones L, Braithwaite BD, Selwyn D, Cooke S, Earnshaw JJ. Neovascularisation is the principal cause of varicose vein recurrence: results of a randomised trial of stripping the long saphenous vein. Eur J Vasc Endovasc Surg 1996;12: ) Fischer R, Linde N, Duff C, Jeanneret C, Chandler JG, Seeber P. Late recurrent saphenofemoral junction reflux after ligation and stripping of the greater saphenous vein. J Vasc Surg 2001;34: ) Kim WS, Kang JH. Endovenous radiofrequency ablation (VNUS R Closure Fast) in varicose veins. J Korean Soc Phlebol 2009;8: ) Merchant R. Endovascular radiofrequency ablation treatment of varicose vein with primary chronic venous insufficiency. In: Proceedings of the 9th the Spring Conference of the Korean Society of Phlebology; 2005 Apr 4; Seoul, Korea: The Korean Society of Phlebology; p

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untitled 대흉외지 2010;43:635-641 DOI:10.5090/kjtcs.2010.43.6.635 임상연구 하지정맥류치료를위한 2 세대고주파열폐쇄술 ( Closure fast) 과기존의고주파열폐쇄술 ( Closure plus) 의임상치험비교분석 김우식 * ㆍ이정상 ** ㆍ정성철 * ㆍ신용철 * Clinical Experience of Closure fast in