Table A1. Clinical Cohort Trials of RFA Ablation of the Great Saphenous Vein.
| Author, Year, Country | Sites, Operators, Anaesthesia | Objective | Follow-Up | Radiofrequency System, Temperature, Pull back Rate | Sample (% Female) | Concomitant or Staged Procedures |
|---|---|---|---|---|---|---|
| Boros 2008 Michigan, US | • 1 site • 3 vascular surgeons • Local tumescent anaesthesia with general anaesthesia |
• To assess the need for high ligation of the SFJ and the subsequent risk of DVT | • 1 month | • Closure System, ClosurePlus catheter • NR |
• 219 p (73% F ) • Mean age 52, 53 • 219 Legs • RFA and ligation (n = 77), RFA only (n = 142) |
SFJ ligation was by surgeon preference (one always, one never, one varied) |
| Dunn 2006 Nevada, US | • 5 sites • Experienced operators (>200 procedures) • Local tumescent anaesthesia with intravenous or oral sedation |
• To determine complication rates relief of pre-operative symptoms and saphenous vein occlusion rates | • 3 days 6 months | • Closure System • 90°C, 5-6 cm pullback • |
• 68 p (85% F) • Mean age 551 years (range 23 - 83) • 85 Legs • GSV < 12 mm |
Concomitant phlebectomy and sclerotherapy performed |
| Goldman 2002 California, US | • 1 site • Dermatologist • Tumescent anaesthesia |
• To evaluate initial experience with RFA saphenous veins | • 6 months | • Closure System • 85°C, • 3.5 cm/sec average pullback rate |
• 47 p (74% F) • 50 Legs • |
Concomitant phlebectomy |
| Hingorani 2004 Florida, US | • 1 site • Vascular surgeon • General anaesthesia (44%), regional femoral block (45%), local anaesthetic with sedation (11%) with local tumescent anaesthesia |
• To evaluate closure rates and incidence of post-operative DVT | • 1 month | • Closure System • 85 °C ,, 2-3 cm pullback |
• 66 p (73% F) • 73 Legs |
Concomitant phlebectomy and subfascial endoscopic perforator ligation when indicated |
| Manfrini 2000 Italy, Sweden, US, UK | • 16 private clinics and university centers in Europe • Vascular surgeons • • General anaesthesia (20%), conduction anaesthesia (50%), local tumescent anaesthesia (30%) |
• To assess clinical outcomes of two different RFA catheters | • 6 months, • 12 months |
• Closure catheters (5F, 8Fr), for veins 2 – 12 mm and Restore catheters (8Fr, 9Fr) for veins 4 – 15 mm) • Closure at 85%C with 2.5 to 3.0 cm/min pull back and Restore catheter at 72)C with pull back rate guided by wall impedance |
• 210 p (73% F) • 151 Legs • 152 veins • Mean age 45 (SD 13 years) |
• Concomitant high ligation of SFJ in 40%. |
| Puggioni 2009 New York, US | • To evaluate the safety of RFA in patients with prior venous thrombotic events • 3 vascular surgeons • General or spinal anaesthesia in first 12 months (43%) and local tumescent anaesthesia in the last 16 months (57%) |
• To evaluate the safety of RFA in patients with prior venous thrombotic events | • 1 month | • Closure System • 85°C with pull back rate 2 cm/min in first 15 months (30%) and 90°C with pullback rate 2-3 cm/min (70%) for remainder |
• 274 p (68% F) • 293 Legs • Mean age 60 years (SD 15 years) • No vein diameter exclusion |
• No concomitant procedures with tumescent anaesthesia |
| Salles-Cunha 2004 Ohio, US | • 1 site • 3 vascular surgeons • Regional or general anaesthesia with local tumescent anaesthesia |
• To evaluate the effectiveness of RFA ablation of saphenous veins | • 8 months | • Closure System • 85°C with mean pullback rate 3 cm/min |
• 84 p (82% F) • Mean age 54 (SD 13 years) • 100 Legs |
• Concomitant SFJ ligation and microphlebectomy (91%) |
| Salles-Cunha 2004 Ohio, US | • 1 site • 3 vascular surgeons • Regional or general anaesthesia with local tumescent anaesthesia |
• To evaluate the development of small vessel networks at the SFJ and in the thigh | • 9 months (range 4 – 25 months) | • Closure System • 85°C with mean pullback rate 3 cm/min |
• 89 p (82% F) • Mean age 54 (SD 13) range 25 – 83 • 106 Legs |
• Concomitant SFJ ligation (93 legs ligated) and phlebectomy |
| Tzillinis 2005 Ohio, US | • 1 site • Vascular surgeons • Regional or general anaesthesia with local tumescent anaesthesia |
• To evaluate RFA operative morbidity in older compared to younger cohort | • Post operative clinical assessment | • Closure System • 85°C with mean pullback rate 2-3 cm/min |
• 421 p • Group 1 ≥ 70 years [35 p (41 legs) mean age 75 ± 4 years • Group 2 < 70 years [386 p (449 Legs) mean age 47 ± 11 years |
• Concomitant SFJ ligation and phlebectomy |
| Vasquez 2007 New York, US | • 1 site • Vascular surgeon • Tumescent anaesthesia and intravenous sedation |
• To identify risk factors associated with RFA treatment failures using venous symptom severity scores | • 4 months | • Closure System • 85°C with 2-3 cm/min pullback rate • |
• 499 p (68% F) • Mean age 53.5 ± 13.3 years • 682 Legs |
• No concomitant adjunctive procedures were performed |
| Weiss 2002 Maryland, US | • 1 site • Vascular surgeons • Tumescent anaesthesia and intravenous sedation |
• To evaluate the effectiveness of RFA in long term follow-up | • 2 years | • Closure System • 85°C ± 3 °C with mean pullback rate 2-3 cm/min |
• 120 p (74.5% F) • Age NR • 140 Legs |
Concomitant phlebectomy (62%) No high ligation was performed |
| Welch, 2006 Maryland,US | • 1 site • Vascular surgeon • General anaesthesia (n = 3) and local, tumescent anaesthesia with intravenous sedation (n = 181) |
• To evaluate the efficacy of RFA alone for symptomatic varicose veins | • 9 months | • Closure System • 85°C to 90°C with 2-3 cm/sec pullback rate |
• 146 p (76% F) • Mean age 48.4 (range 22 – 78) • 184 Legs |
Staged phlebectomy or sclerotherapy |
| VNUS Closure Treatment Study Group | ||||||
| Merchant – Closure Group 2002 | • 30 registry sites in United States, Europe and Australia • Vascular surgeons • General anaesthesia at some sites, most sites used local anaesthesia (tumescent or regional or both) with or without sedation |
• To evaluate 2-year efficacy outcomes after RFA in multicenter international industry sponsored prospective registry | • 2 years | • Closure System • 85°C with pullback rate 3 cm / min |
• 286 p (74% F) • Mean age 46.7 years (range, 19 to 78 years) • 318 Legs |
• Concomitant procedures included phlebectomy (58.6%) and sclerotherapy (3.5%). No high ligation of the SFJ was done |
| Nicolini – Closure Group 2005 | • 23 registry sites • Vascular surgeons • General anaesthesia usually performed, local anaesthesia (regional or tumescent) was used at some sites |
• To evaluate 3-year efficacy outcomes after RFA in multicenter international industry sponsored prospective registry | • 3 years (68 legs from 8 centers • 2 years (148 legs from 17 centers) • 1 year (252 legs from 23 centers) |
• Closure System • 85°C with pullback rate 3 cm / min |
• 294 p (76.9% F) • Mean age 46.3 years (range, 18 – 97 years) • 330 Legs |
• Phlebectomy either concurrent or in follow-up performed in 61% • No high ligation was performed |
| Merchant – Closure Group 2005 | • 12 registry sites • Vascular surgeons • Tumescent anaesthesia with 45.5% of cases |
• To evaluate 4-year efficacy outcomes after RFA in multicenter international industry sponsored prospective registry | • 4 Years (98 evaluated of 696 legs) • 3 Years (114 evaluated of 886 Legs) • 2 Years (210 evaluated of 1,026 Legs) • 1 Year (384 evaluated of 1,077 Legs) |
• Closure System • 85°C with pullback rate 3 cm / min |
• 890 p (78.1% F) • Mean age 47.6 years (range, 15 - 97) • 1078 Legs • (GSV only, included, 58 veins > 12 mm diameter)) |
• Concomitant procedures included phlebectomy or sclerotherapy. No high ligation was performed |
| Merchant – Closure Group 2005 | • 32 registry sites • Vascular surgeons • General anaesthesia usually performed, local anaesthesia (regional or tumescent) was used at some sites |
• To evaluate 5-year efficacy outcomes after RFA in multicenter international industry sponsored prospective registry | • 5 years (117 evaluated of 406 legs) • 4 Years (119 evaluated of 833 legs) • 3 years (133 evaluated of 991 legs) • 2 Years (263 evaluated of 1,141 legs) • 1 year (473 evaluated of 1,206 legs) |
• Closure System • 85°C with pullback rate 3 cm / min |
• 1006 p (78.1% F) • Average age 47.4 years (range, 15 to 97 years) • 1,222 Legs • All veins not treated with high ligation were included |
• Concomitant procedures included phlebectomy or sclerotherapy. No high ligation was performed |
| Chandler- Closure Group 2000 | • 27 registry sites • Vascular surgeons • General anaesthesia usually performed, local anaesthesia (regional or tumescent) was used at some sites |
• To compare efficacy of RFA with and without SFJ ligation | • 1 year | • Closure System • 85°C with pullback rate 3 cm / min |
• 166 p (77.1% F) • Age range 19 to 78 years • 60 legs high ligation, 106 legs without high ligation |
• Concomitant phlebectomy with high ligation (60%) and without high ligation (79%) |
| Pichot – Closure Group 2004 | • 5 registry sites in Austria, France and the United States • Vascular surgeons • General anaesthesia usually performed, local anaesthesia (regional or tumescent) was used at some sites |
• To assess clinical and duplex ultrasound findings for patency and neovascularization in the groin and thigh 2 years after GSV RFA | • 2 years | • Closure System • 85°C with pullback rate 3 cm / min |
• 56 p (73% F) • Median age 50 years (range, 27 to 74 years) • 63 Legs (No high ligation was performed) |
• Concomitant phlebectomy (50 Legs) and staged phlebectomy or sclerotherapy (20 legs) |
| Closure System with ClosureFast Catheter Clinical Study Group | ||||||
| Calcagno 2009 Pennsylvania, US | • 1 site • 2 operators • Local tumescent anaesthesia |
• To evaluate efficacy of the new generation ClosureFast RFA catheter larger (> 12mm diameter) veins | • 6 months | • Closure System – ClosureFast catheter • 120°C |
• 310 p (F NR) • 342 GSV and SSV 246 veins ≤ 12mm (mean diameter 8 mm ± 3 mm), 96 veins > 12 mm (mean diameter 17 mm ± 4 mm) |
• NR |
| Proebstle 2008 Germany, France | • 8 sites in Germany, and France • Vascular surgeons • Local tumescent anaesthesia |
• To evaluate the feasibility, safety and early clinical outcomes of RF-powered segmental thermal obliteration (RSTO) | • 6 months | • Closure System – ClosureFast catheter • 120°C with 20 second durations |
• 194 p (73.8% F) • Mean age 50.5 ± 13.6 years ( range, 18 to 80) • 252 Legs |
• Concomitant phlebectomy (71.4%) and foam sclerotherapy for (13.9%) for tributary veins |
| Creton 2010 Germany, France | • 8 sites in Germany and France • Vascular surgeons • Local tumescent anaesthesia |
• To evaluate the 1 year clinical outcomes of RSTO | • 1 year | • Closure System – ClosureFast catheter • 120°C with 20 second durations |
• 225 p (73.8% F) • Mean age 50.6 ± 13.6 years (range: 18 to 80) • 295 Legs |
• Concomitant phlebectomy (56.6%) and foam sclerotherapy for (12.9%) for tributary veins |