Table 4. Imaging Follow-Up and Outcomes of RFA ClosurePlus Catheter Ablation of Great Saphenous Vein.
| Author, Year, Country | Sample | Treatment Success | ≤3 Months | 6 Months |
|---|---|---|---|---|
| Boros 2008 Michigan, US (72) | 219 p ( 219 Legs) 77 p with RF and SFJ ligation 142 p RF only |
• Complete ablation as absence of flow in treated vein on duplex ultrasound • Incomplete ablation defined as treated vein having obliterated and patent areas • No ablation patent treated vein |
1 month complete ablation RFA + ligation = 92% (71/77) RFA only = 84% (119/142) p = .096 |
- |
| Dunn 2006 Nevada, US (69) | 68 p (85 Legs) | • Occlusion of treated vein and absence of reflux on duplex ultrasound at 3 days and 6 months | 3 days 96% (80/83) Occluded and absent reflux |
88% 64/73) Occluded and absent reflux |
| Goldman 2002 California, US (68;74) | 47 p (50 Legs) | • Occlusion and absence of reflux in treated vein on duplex ultrasound at 6, 9 , 12, 18 and 24 months | 1 month 68% (28/41) occluded without reflux Recanalization with reflux (n = 4) without reflux (n = 9) |
|
| Hingorani 2004 Florida, US (75) | 66 p (73 Legs) 73 GSV |
• Occlusion of treated vein on duplex ultrasound at 1 month | 1 month 96% (70/73) |
|
| Salles-Cunha 2004 Ohio, US (77) | 84 p (100 Legs) RF and SFJ ligation in 87% procedures | • Occlusion of treated vein on duplex ultrasound and classified as absent (non-visualized), occluded (shrunk, atretic, fibrotic, thrombosed), or recanalized • Average F-Up 8 months (range 4 – 14 months) |
Average 8 months Successful ablation 85% (Entire segment absent n=53) or occluded (n = 32), recanalized 15% (15/100) |
|
| Vasquez 2007 New York, US (70) | 499 p (682 Legs) ( 566 GSV, 95 AASV, 21 SSV) | • Vein occlusion on color flow duplex ultrasound at 4 days, 4 weeks, 4 months | 4 months Overall occlusion rate 87.1% | |
| Occlusion factors: Women RR = 0.19 (95% CI; 0.09 – 0.41) p < .0001 | ||||
| Catheter size 6F vs 8FR RR = 0.71 (95%CI; 0.43 – 1.25) p = .28 | ||||
| Tumescent fluid (> 250 ml) RR = 0.59 (95%CI; 0.34 – 1.02) p = .06 | ||||
| Weiss 2002 Maryland, US (71) | 120 p (140 Legs) | • Vein occlusion on duplex ultrasound at 1 week,, 6 weeks, 6 months, 1 year and 2 years | 1 week 98% (137/140) occlusion no flow 6 weeks 4% (5/140) flow |
3% (3/98) recanalized |
| At 2 years, 90% (19/21)treated vein completely absent | ||||
| Welch, 2006 Maryland, US (76) | 146 p (184 Legs) | • Vein occlusion on duplex ultrasound at 1 week,, 2-3 months | 1 week 77.7% (143/184) completely occluded partial patency ( 12 limbs with <10 cm patency, 17 limbs patency > 10 cm 3.8% (n = 7 ) totally patent, all with 6F catheter |
- |
| Mafrini – Endovenous Reflux Management Group 2000 Italy, Sweden, US ,UK (59) | 142 p (151 Legs, 152 veins) with ClosurePlus catheter | • Occlusion of treated vein on duplex ultrasound at 1 week, 6 weeks, 6 months, 12 months • Closure catheter mean F-Up 4.7 months ,Restore catheter mean F-UP |
1 week C;losure catheter 93% (141/151) No flow no reflux Closure at mean 4.7 mo F-UP 6% recurrent reflux rate and 4% incidence recurrent varicities |
|
| VNUS Closure Treatment Study Group | ||||
| Merchant – Closure Group 2005 (61) | Sub-cohorts of VNUS Closure Study Group - 5 yr-results – Treated before October 2004 at 34 centers 1,006 p (1,222 legs) – 12 centers contributed 5-yr data | • Vein occlusion on duplex ultrasound at 1wk, 6 months, 1, year, 2 years, 3 years, 4 years, 5 years • Vein occlusion defined as no evidence of flow from 3 cm below the SFJ along the length of the treated vein • Reflux defined as any evidence of reverse flow > 0.5 seconds in any treated vein segment or in the SFJ area (or SPJ) |
1 week 96.8% vein occlusion (1,222 VAR and 985 available for follow-up) |
GSV refers to the great saphenous vein; SSV, small saphenous vein; VAR, veins at risk