Endovenous radiofrequency powered segmental thermal ablation (Closure FAST) of great saphenous veins

Summary

Background: Radiofrequency powered segmental thermal ablation Closure FAST has become a globally engaged technology for ablation of incompetent great saphenous veins (GSVs). Mid-term results of slowly resolving side effects are still not described. Methods: RSTA-treated GSVs (n = 295) were followed for 24 months in a prospective multicenter trial. Clinical control visits included flow and reflux analysis by duplex-ultrasound and assessment of treatment related side effects at all times. Results: 280 of 295 treated GSVs (94.9%) were available for 24 months follow-up. According to the method of Kaplan and Meier at 24 months after the intervention 98.6% of treated legs remained free of clinically relevant axial reflux. The average VCSS score improved from 3.9 ± 2.1 at screening to 0.7 ± 1.2 at 24 months follow-up (p < 0.0001). While only 41.1% of patients were free of pain before treatment, at 24 months 99.3% reported no pain and 96.4% did not experience pain during the 12 months before. At 24 months n=3 legs showed pigmentation along the inner thigh and one leg showed study-treatment related paresthesia. Conclusion: Radiofrequency powered segmental thermal ablation Closure FAST showed a very moderate side-effect profile in conjunction with a high and durable clinical success rate.

Zusammenfassung

Hintergrund: Die radiofrequenzbetriebene segmentale thermische Ablation Closure FAST wurde zwischenzeitlich zu einer weltweit eingesetzten Technik zur Ausschaltung insuffizienter Stammvenen. Methodik: In einer europäischen Multicenter-Studie wurden insgesamt 295 insuffiziente Venae saphena magnae an 225 Patienten behandelt. In der bislang über 24 Monate durchgeführten Nachkontrolle wurden neben duplexsonographischen und klinischen Untersuchungen auch Patientenbefragungen unter Einsatz von Analogskalen zur Erhebung von subjektiven patientenbezogenen qualitativen Daten eingesetzt, um zusätzlich zu hämodynamischen und klinischen Kriterien auch bestimmte Aspekte von therapieassoziierten Nebenwirkungen und Einschränkungen der peri- und postinterventionellen Lebensqualität zu erfassen. Dabei konnten nach zwei Jahren rund 95% der Patienten und behandelten Beine nachuntersucht werden. Ergebnisse: Hämodynamisch bemerkenswert zeigten nur 4 von 280 nachuntersuchten Beinen nach 24 Monaten einen axialen Reflux, d. h., 98,6% der Beine waren frei von klinisch relevanten Refluxen. Dabei verbesserte sich der durchschnittliche VCSS (venous clinical severity score) von 3,9 ± 2,1 vor der Studienbehandlung auf 0,7 ± 1,2 nach 24 Monaten (p < 0,0001). Während vor der Studienbehandlung nur 41,1% der Patienten keine Schmerzen in dem behandelten Bein beklagten, waren bei der 24 Monatskontrolle 99,3% der Patienten schmerzfrei und 96,4% waren auch in den 12 Monaten zuvor ohne Schmerzen geblieben. Nach 24 Monaten waren an Nebenwirkungen, die mit der Studientherapie assoziiert waren, Pigmentierungen an drei Beinen, eine Parästhesie an einem Bein verblieben. Schlussfolgerung: Die radiofrequenzbetriebene segmentale thermische Ablation Closure FAST ist eine effektive Behandlungsmethode zur Stammvenenablation, verbunden mit einem sehr moderaten Nebenwirkungsprofil.

Keywords

Endovenous - saphenous vein - varicose vein - radiofrequency - laser - reflux - venous insufficiency - chronic venous disease - duplex ultrasound

Schlüsselwörter

Endovenös - Vena saphena - Varikose - Radiofrequenz - Laser - Reflux - venöse Insuffizienz - chronisch-venöse Insuffizienz - Duplex-Ultraschall

^* Additional members of the European Closure Fast Study Group: B. J. Alm, Dermatologikum Hamburg, Germany; O. Göckeritz, C. Wenzel, Venenzentrum Leipzig, Germany; C. Lebard, Hospital St. Michel, Paris, France; O. Pichot, C Sessa, CHU Service de Chirurgie Vasculaire, Grenoble, France; C. G. Schmedt, Ludwig-Maximilian Universität, München, Germany; T. Noppeney, Gemeinschaftspraxis Nürnberg, Germany; D. Creton. Clinique Ambroise Paré, Nancy, France

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