Table A8: Clinical Trials Involving Endovascular Laser Ablation vs. Surgical Treatment for VV.
| Endovascular Laser | Surgical Arm | ||||||
|---|---|---|---|---|---|---|---|
| Author, Year, Country | Trial Design, Sample | Setting, Operator, Anesthesia | Laser λ, Power Mode, Energy (J/cm) | Concurrent or Staged Procedures | Surgical Technique | Concurrent or Staged Procedures | Follow-Up |
| Darwood 2006 UK |
3-arm RCT 118 p (57%F) |
|
810nm Arm 1: 12W power on pulse mode with pullback rate 2-3 mm/sec with 60.9 J/cm (49.2-68.8) Arm 2: 14 W continuous mode withdraw rate 2-3 mm/sec with 71.1 J/cm (64.7-80.6) |
Staged sclerotherapy at 6 wks for residual varices if requested by patient | Arm 3. High ligation SFJ and inversion stripping GSV to the knee | Concurrent multiple phlebectomies | 12 month |
| DeMedeiros 2005 Brazil |
2-arm within person RCT, 20 p (95% F) |
|
810nm 12-14 W on pulsed mode |
Concurrent high ligation GSV and all tributaries, mini phlebectomies and ligation insufficient perforator veins | High ligation GSV and forward total stripping GSV to the ankle | Concurrent mini phlebectomies and ligation all GSV tributaries and insufficient perforator varices | 9 month (range: 2-18) |
| Disselhoff 2008, 2009 Netherlands |
2-arm RCT + CE study 120 p (69% F) |
|
810nm 14 W continuous pulse mode 57 (41-86) J/cm |
Staged 6-wk post-op sclerotherapy or phlebectomy for persistent varices | Ligation and liquid cryosurgery stripping and avulsion of tributaries | Staged at 6-wk post-op sclerotherapy or phlebectomy for persistent varices | 2 year |
| Kalteis 2008 Austria |
2-arm RCT 100 p (75% F) |
|
810nm Variable watts declining down leg (10-12W, 6 W, 4-6W) Targeted energy level 20-30 J/cm |
Concurrent high ligation of GSV and ligation of all side tributaries followed by ELT. and stab avulsions of all side tributaries | Dissection SFJ junction, high ligation of GSV, ligation of all side tributaries followed by GSV stripping | Concurrent stab avulsions of all marked tributaries | 4 week |
| Rasmusson 2007, 2009 Denmark |
2-arm RCT + costing study 121 p (69% F) |
|
980nm 12 W pulse mode mean delivered energy 73.5 J/cm (range 57 – 95.4) |
Concurrent all varices removed by miniphlebectomies | High ligation and perforate invagination stripping of GSV | Concurrent all varices removed by miniphlebectomies | 6 month 2 year |
| Theivacumar 2009 UK |
2-arm mixed RCT 127 p (68 randomized) (61% F) |
|
810nm 12 W pulse mode |
Staged within 12 wks foam sclerotherapy of residual varicoses | SFJ ligation and division of all tributaries with GSV stripping to the knee | Concurrent multiple stab avulsions of varices | 2 year |
RCT refers to randomized controlled trial; GSV, great saphenous vein; SFJ, saphenofemoral junction