Phlebologie 2010; 39(02): 61-68
DOI: 10.1055/s-0037-1622298
Original article
Schattauer GmbH

VNUS Closure radiofrequency ablation of varicose veins

From Closure PLUS to Closure FASTEntwicklung der VNUS-Radiofrequenzkatheter-Therapie in der Behandlung der Varikose
J. Alm
1   Gefäßabteilung am Dermatologikum Hamburg
,
J. Böhme
1   Gefäßabteilung am Dermatologikum Hamburg
,
M. Kensy
1   Gefäßabteilung am Dermatologikum Hamburg
› Author Affiliations
Further Information

Publication History

Received: 22 February 2010

accepted: 22 February 2010

Publication Date:
04 January 2018 (online)

Summary

Endovenous procedures are increasingly being used to eliminate epifascial variose veins. The radiofrequency therapies VNUS Closure and VNUS Closure FAST Catheter have established themselves and boast very good results compared to other endovenous procedures with regard to closure rates and postoperative quality of life. Equipment and method: Between February 2005 and December 2009, a total of 2413 patients comprising 3366 great and small saphenous veins were operated upon at the Vascular and Venous Diseases Department of DERMATOLOGIKUM HAMBURG. 2241 great and small saphenous veins were treated with the VNUS Closure FAST catheter, 1125 great and small saphenous veins were treated with the Closure PLUS catheter system. Additionally, 264 recurrent varicose veins were treated with the Closure FAST system. Ultrasound examinations were conducted 7 days after the treatment, again 6 weeks after the treatment, and at the follow-up examination one year after treatment. Any recanalisations were treated immediately. Between January 2007 and January 2009, 57 patients were also treated for perforant veins between stages C-4 and C-6. Gender and age distributions, as well as CEAP classifications corresponded to standard distributions. Compression stockings were only administered in the case of advanced chronic venous insufficiency (C-4 to C-6). The patients were anticoagulated before treatment by means of a low molecular weight heparin as a single shot prophylactic. Anticoagulation through thrombocyte aggregation inhibitors or dicumarin was continued. Results: 1089 great and small saphenous veins were examined after removal with Closure PLUS radiofrequency therapy. The primary closure rate after 6 weeks was 98.9%; after one year, 91.2%; after two years 99.0%; after three years, 98.2%; and after four years, 100%. 2241 great and small saphenous veins were treated with the VNUS Closure FAST Radiofrequency System. 2096 great and small saphenous veins were examined after treatment. The primary closure rate after 7 days was 99.7%; after 6 weeks, 99.6%; after one year, 98.8%; and after two years, 100%. The rate of minor complications after Closure FAST Radiofrequency catheter treatment of the great saphenous vein was 5.3%; after treatment of the small saphenous vein, 5.9% in total. No major complications – such as deep vein thromboses or pulmonary embolisms – were caused, and neither was burning of the skin. The closure rate one week after RFS treatment was 84.6%; after 6 weeks, 86.2%; and after one year, 78.3%. In all of the recurring varicose veins, the recirculation was successfully eliminated. Conclusion: The VNUS Closure FAST Radiofrequency catheter represents a standardised, established procedure for treating epifascial varicose veins to ensure the certain elimination of recirculation. The development of Closure PLUS 6-French and 8-French catheter into Closure FAST Radiofrequency catheter has led not only to a reduced operation duration but also a safe and high closure rate after follow-up. With the new concept of segmental ablation the Closure FAST system eliminates the catheter pullback variability and standardises and simplifies the procedure. The success of the treatment is shown by the complete decomposition of the vein underneath the inflow of the superficial epigastric vein or the inflow of the gastrocnemic veins. However, the long term results for the Closure FAST system are awaited eagerly. The current high closure rates and high patient satisfaction rates give us cause to look ahead with hope.

Zusammenfassung

Für die Ausschaltung der epifaszialen Varikose werden zunehmend endovenöse Verfahren eingesetzt. Besonders die Radiofrequenztherapie VNUS Closure und der VNUS-Closure-FAST-Katheter haben sich in der Behandlung etabliert und weisen im Vergleich zu anderen endovenösen Verfahren sehr gute Ergebnisse hinsichtlich Verschlussrate und postoperativer Lebensqualität auf. Material und Methode: In unserer Gefäßabteilung wurden von Februar 2005 bis Dezember 2009 insgesamt 2413 Patienten an 3366 Stammvenen operiert. 2241 Stammvenen wurden mit dem VNUS-Closure-FAST-Katheter behandelt, 1125 Stammvenen mit dem Closure-PLUS-Kathetersystem. Zusätzlich erfolgte die Behandlung von 264 Rezidivvarikosen mit dem Closure-FAST-System. Ultraschalluntersuchungen erfolgten nach sieben Tagen, sechs Wochen und im Jahres-Follow-up. Rekanalisierungen wurden umgehend nachbehandelt. Von Januar 2007 bis Januar 2009 wurden 57 Patienten zusätzlich an 78 Perforansvenen (Stadium C-4 bis C-6) behandelt. Die Geschlechts- und Altersverteilung sowie die CEAP-Einteilung entsprachen den Standardverteilungen. Kompressionsstrümpfe wurden nur bei weit fortgeschrittener chronisch-venöser Insuffizienz (C-4 bis C-6) verordnet. Antikoaguliert wurden die Patienten präoperativ mit niedermolekularem Heparin (Single-shot-Prophylaxe). Eine Antikoagulation unter Thrombozytenaggregationshemmern oder Dicumarin wurde beibehalten. Ergebnisse: 1089 Stammvenen konnten nach Closure-PLUS-Radiofrequenzablation nachuntersucht werden. Die primäre Verschlussrate betrug nach sechs Wochen 98,9%, nach einem Jahr 91,2%, nach zwei Jahren 99,0%, nach drei Jahren 98,2% und nach vier Jahren 100%. Mit dem VNUS-Closure-FAST-Radiofrequenzkathetersystem wurden 2241 Stammvenen behandelt. 2096 Stammvenen konnten nachuntersucht werden. Die primäre Verschluss rate lag nach sieben Tagen bei 99,7%, nach sechs Wochen bei 99,6%, nach einem Jahr bei 98,8%, nach zwei Jahren bei 100%. Die Minor- Komplikationsrate nach Closure-FAST-Radiofrequenzkatheter-Behandlung der Vena saphena magna lag bei 5,3%, nach Venasaphena-parva-Behandlung bei insgesamt 5,9%. Mayor-Komplikationen wie tiefe Venenthrombosen oder Lungenembolien wurden nicht induziert, auch keine Hautverbrennungen. Die Verschlussrate nach RFS-Behandlung betrug nach einer Woche 84,6%, nach sechs Wochen 86,2%, nach einem Jahr 78,3%. Bei allen behandelten Rezidivvarikosen konnte der Rezirkulationskreislauf erfolgreich ausgeschaltet werden. Schlussfolgerung: Mit dem VNUS-Closure-FAST-Radio frequenzkatheter besteht ein standardisiertes, etabliertes Verfahren zur Behandlung der epifaszialen Varikose zur sicheren Ausschaltung des Rezirkulationskreislaufes. Die Weiterentwicklung vom Closure-PLUS-6- und -8-French-Katheter zum Closure-FAST-Radiofrequenzkatheter hat neben der deutlich verkürzten Operationszeit zu sicheren und hohen Verschlussraten im Follow-up geführt. Der Behandlungserfolg wird durch den kompletten Abbau der Stammvene unterhalb des Zustromes der Vena epigastrica superficialis bzw. des Einstroms der gastroknemischen Venen dokumentiert.

 
  • Literatur

  • 1 Almeida JI, Kaufmann J, Göckeritz O. et al. Radiofrequency endovenous closure FAST versus Laser Ablation fort he treatment of great saphenous reflux: a multicenter, single-blinded, randomized study (RECOVERY Study). J Vasc Interv Radiol 2009; 20: 752-759.
  • 2 Blomgren L, Johannson G, Dahlberg-Akerman A. et al. Reccurent varicose veins: incedience, risk factors and groin anatomy. Eur J Vasc Endovasc Surg 2004; 27: 269-274.
  • 3 Chandler JG, Pichot O, Sessa C. et al. Defining the role of extended saphenofemoral junction ligation: A prospective comparative study. J Vasc Surg 2000; 32: 941-953.
  • 4 Chandler JG, Pichot O, Sessa C. et al. Treatment of primary venous insufficiency by endovenous saphenous vein obliteration. J Vasc Surg 2000; 34: 201-214.
  • 5 Fassiadis N, Kianifard B, Holdstock JM, Whiteley MS. Ultrasound changes at the saphenofemoral junction and in the long saphenous vein during the first year after VNUS closure. Int Angiol 2002; 21: 272-274.
  • 6 Frings N, Nelle A, Tran P. et al. Unvermeidbares Rezidiv und Neoreflux nach korrekter Vena saphena magna Crossektomie: Neovaskularisation?. Phlebologie 2003; 32: 96-100.
  • 7 Frings N, Glowacki P, Tran P. et al. II. und III. Krossenrezidiv der Vena saphena magna/ Vena saphena parva. Phlebologie 2006; 35: 81-86.
  • 8 Haas E, Burkhardt T, Maile N. Rezidivhäufigkeit durch Neoangiogenese und modifizierte Krossektomie. Prospektiv-randomisierte, farbduplexkontrollierte Studie. Phlebologie 2005; 34: 101-104.
  • 9 Hinchliffe RJ, Ubhi J, Beech A, Ellison J, Braithwaite BD. A prospective randomized controlled trial of VNUS Closure versus surgeryfor the treatment of recurrent long saphenous varicose veins. Eur J Vasc Endovasc Surg 2006; 31: 212-218.
  • 10 Hingorani AP, Ascher E, Markevich N. et al. Deep venous thrombosis after radiofrequency ablation of greater saphenous vein: a word of caution. J Vasc Surg 2004; 40: 500-504.
  • 11 Kabnick LS, Cayne N, Jacobowitz G, Lamparello P, Maldonado T, Rockman C. Endovenous procedures in varicose veins. Phlebologie 2008; 37: 229-236.
  • 12 Langer C, Fischer R, Fratila A. et al. Leitlinien zur operativen Behandlung von Venenkrankheiten. Phlebo logie 1998; 27: 65-69.
  • 13 Luebcke T, Brunkwall J. Systematic review and metaanalysis of endovenous radiofrequency obliteration, endovenous laser therapy and foam sclerotherapy for primary varicosis. J Cardiovasc Surg 2008; 49: 213-233.
  • 14 Lurie F, Creton D, Eklof B. et al. Prospective randomized study of endovenous radiofrequency obliteration (Closure procedure) versus ligation and stripping in a selected patient population (EVOLVeS Study). J Vasc Surg 2003; 38: 207-214.
  • 15 Lurie F, Creton D, Eklof B. et al. Prospective randomized study of endovenous radiofrequency obliteration (Closure) versus ligation and vein stripping (EVOLVeS Study): Two-year follow-up. Eur J Vasc Endovasc Surg 2005; 29: 67-73.
  • 16 Manfrini S, Gasbarro V, Dantelsson G. et al. Endovenous management of saphenous vein reflux. Endo venous reflux management Study Group. J Vasc Surg 2000; 32: 330-342.
  • 17 Markovic JN, Shortell CK. Update on Radiofrequency Ablation. Pers Vasc Surg Endovasc Ther 2009; 21: 82-90.
  • 18 Merchant RF, Pichot O. Long-term outcomes of endo venous radiofrequency obliteration of saphenous reflux as a treatment for superficial venous insufficiency. J Vasc Surg 2005; 42: 502-509.
  • 19 Morrisson N. Saphenous ablation: What are the choices, Laser or RF Energy. Semin Vasc Surg 2005; 18: 15-18.
  • 20 Mumme A, Burger P, Hummel T, Frings N, Hartmann M, Schonath M, Schwahn-Schreiber C, Stenger D, Stücker M. Der lang belassene Saphenastumpf. Phlebologie 2007; 36: 256-259.
  • 21 Nicolini P. Closure Group. Treatment of primary varicose veins by endovenous obliteration with the VNUS Closure system: results of a prospective multicenter study. Eur J Vasc Endovasc Surg 2005; 29: 433-439.
  • 22 Noppeney T, Kluss HG, Gerlach H. et al. Leitlinie zur Diagnostik und Therapie des Krampfadernleidens. Gefäßchirurgie 2004; 4: 290-308.
  • 23 Noppeney T, Noppeney J, Winkler M. Update der Ergebnisse nach Radiofrequenzobliteration zur Ausschaltung der Varikose. Gefäßchirurgie 2008; 13: 258-264.
  • 24 Peräla J, Rautio T, Biancari F. et al. Radiofrequency endovenous obliteration versus stripping of the long saphenous vein in the managment of primary varicose veins: 3-year outcome of a randomized study. Ann Vasc Surg 2005; 19: 1-4.
  • 25 Perrin M. Endoluminal treatment of lower limb varicose veins by endovenous laser and radiofrequency techniques. 2004 19. 170-178.
  • 26 Pichot O, Kabnick LS, Creton D. et al. Duplex ultrasound scan findings two years after great saphenous vein radiofrequency endovenous obliteration. J Vasc Surg 2004; 39: 189-195.
  • 27 Pichot O, Sessa C, Bosson JL. Duplex imaging analysis of the longsaphenous vein reflux: basis for strategy of endovenous obliteration treatment. Int Angiol 2002; 21: 333-336.
  • 28 Proebstle TM. Endovenöse Lasertherapie der Varikose. Phlebologie 2003; 32: 131-137
  • 29 Proebstle TM, Gül D, Lehr A. et al. Infrequent early. recanalization of greater saphenous vein after endovenous laser treatment. J Vasc Surg 2003; 38: 511-516.
  • 30 Proebstle TM, Vago B, Alm J, Göckeritz O, Lebard C, Pichot O. Treatment of the incompetent great saphenous vein by endovenous radiofrequency powered segmental thermal ablation: first clinical experience. J Vasc Surg 2008; 47: 151-156.
  • 31 Rautio T, Ohinmaa A, Peräla J. et al. Endovenous obliteration versus conventional stripping operation in the treatment of primary varicose veins: a randomized controlled trial with the comparison of the costs. J Vasc Surg 2002; 5: 958-965.
  • 32 Ravi R, Trayler EA, Barrett DA, Diethrich EB. Endovenous thermal ablation of superficial venous insufficiency of the lower extremity: single-center experience with 3000 limbs treated in a 7-year period. J Endovasc Ther 2009; 16: 500-505.
  • 33 Sadick NS. Advances in the treatment ofvaricose veins: ambulatory phlebectomy, foam sclerotherapy, endovascular laser and radiofrequency closure. Adv Dermatol 2006; 22: 139-156.
  • 34 Schmedt CG, Sroka R, Steckmeier S. 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; 3: 318-325.
  • 35 Stötter L, Schaaf I, Bockelbrink A. et al. Radiowellenobliteration, invaginierendes oder Kryostripping. Welches Verfahren belastet den Patienten am wenigsten?. Phlebologie 2005; 34: 19-24.
  • 36 Van den Bos RR, Arends L, Kocknert M, Neumann M, Nijsten T. Endovenous therapies of lower extremity varicosities: a meta-analysis. J Vasc Surg 2009; 49: 230-239.
  • 37 VNUS® Medical Technologies Inc. VNUS® Closure FASTTM catheter instructions for use. San Jose: VNUS Medical Technologies Inc.; 2007
  • 38 VNUS® Medical Technologies Inc. VNUS® Closure FASTTM Radiofrequency brochure. San Jose: VNUS Medical Technologies Inc; 2007
  • 39 Wagner WH, Levin PM, Cossman DV, Lauterbach SR, Farber A. Early experience with radiofrequency ablation of the greater saphenous vein. Ann Vasc Surg 2004; 18: 42-47.
  • 40 Weiss RA. Comparison of endovenous radiofrequency versus 810 nm diode laser occlusion of large veins in an animal model. Dermatol Surg 2002; 28: 56-61.
  • 41 Zan S, Contessa L, Varetto G, Barra C, Conforti M, Casella F, Rispoli P. Radiofrequency minimally invasive endovascular treatment of lower limbs varicose veins: clinical experience and literature review. Minerva Cardioangiol 2007; 55: 443-458.
  • 42 Zikorus AW, Mirizzi MS. Evaluation of setpoint temperature and pullback speed on vein adventitial temperature during endovenous radiofrequency energy delivery in an in-vitro model. Vasc Endovascular Surg 2004; 38: 167-174.