Table 8.
Reports of radiofrequency treatment of varicose veins
| Author Publication Year | Evidence | Study Design (Sample Size) | Condition | Intervention | Number of Treatments/Intervals | Outcome Measures | Clinical Outcomes | Patient Reported Outcomes | Adverse events |
|---|---|---|---|---|---|---|---|---|---|
| Dunn et al. 2006 (45) | 2 | Prospective nonrandomized (n = 68; 85 extremities) | Incompetent GSV | Endovenous radiofrequency ablation (ERA) w/tumescent anesthesia and sedation | 1 session | Duplex ultrasound (DUS) Occlusion |
Occlusion rate: 96% at 3 days 90% at 6 months Overall success rate: 88% at 6 months |
Not reported | At 3 days (n=83): Ecchymosis 13% Erythema 13% Hematoma 2% Hyperpigmentation 1 pt At 6 months (n=73): Hyperpigmentation 3% Paresthesia 4% |
| Garcia-Madrid et al. 2013 (46) | 3 | Prospective nonrandomized (n = 59; 67 extremities) | Incompetent GSV | ERA w/ tumescent anesthesia | 1 session | DUS Occlusion | Occlusion rate: 100% | Not reported | Erythema 1 pt Class 1 heat-induced thrombosis 1 pt |
| Gibson et al. 2017 (47) | 1 | Randomized control trial (n = 222) | Incompetent GSV | Cyanoacrylate closure (CAC) w/o anesthesia Radiofrequency ablation (RFA) w/ tumescent anesthesia |
1 session | DUS Occlusion Symptoms |
Occlusion rate
At 1 year: RFA 97.0% CAC 97.2% At 2 years: RFA 94.0% CAC 95.3% |
Patient satisfaction at 2 years: RFA 75% CAC 79.1% |
At 12–24 months: Pain (RFA 21%; CAC 30%) Aching (RFA 34%; CAC 29%) Heaviness (RFA 14%; CAC 13%) Swelling (RFA 16%; CAC 16%) |
| Mallick et al. 2016 (48) | 4 | Retrospective cohort (RF n = 7,355; total n = 144,098) | Incompetent GSV | RFA Sclerotherpy Laser ablation |
1 session | Rates of new venous ulcers Rates of additional interventional treatment Disease progression |
New venous ulcers at 1 year:
RF 2.4% Sclerotherapy 1.2% Laser ablation 2.2% Additional treatment sought at 1 year: RF 53.3% Sclerotherapy 63.6% Laser ablation 66.8% Disease progression at 2 years: RF 42.4% Sclerotherapy 28.6% Laser ablation 37.8% |
None collected | Not reported |
| Mendes de Almeida et al. 2016 (49) | 1 | Randomized, controlled trial (n = 18) | Incompetent GSV | ERA in one leg and conventional surgery in the other; both w/ spinal anesthesia | 1 session | DUS occlusion Reflux sapheno-femoral junction (SFJ) and GSV |
DUS Occlusion: 8/10 (80%) at 12 months Reflux SFJ: 0/10 (0%) at 12 months Reflux GSV: 0/15 (0%) at 12 months |
Patient satisfaction at 6 months (1–10): CS 6.93±2.70 RFA 6.86±2.71 Pain at 6 months (1–10): CS 5.64±3.80 RFA 3.71±3.27 |
Not reported |
| Proebstle et al. 2011 and 2015 (57–58) | 3 | Prospective nonrandomized (n = 225; 295 extremities) |
Incompetent great saphenous vein (GSV) | Radiofrequency segmental thermal ablation (RSTA) |
1 session | DUS Occlusion Venous Clinical Severity Score (VCSS) Pain (0–10) |
DUS Occlusion: 92.6% at 3 years 91.9 % 5 years Avg VCSS: Baseline: 3.9 ±2.1 3 years: 0.9 (p=0.05) 5 years: 1.3 Pain: Baseline 17.3% w/ daily pain 3 years: 1.4% w/ daily pain 5 years: 2% w/ daily pain |
None collected | 1 Week: Ecchymosis 5.8% Paresthesia 3.4% Pigmentation 2.4% Erythema 2% 3 years: Leg hyperpigmentation 1 pt Persisting paresthesia 1 pt 5 years: Not reported |
| Schuller-Petrovic et al. 2016 (50) | 4 | Retrospective cohort (n = 258; 389 extremities) | Incompetent GSV and superficial saphenous vein (SSV) | RSTA | 1 session | DUS Occlusion |
DUS at 5 years: 78.5% GSV 58% SSV |
Not Reported | Hypesthesia 1% Hyperesthesia 2% Ecchymoses 4% Phlebitis 4% Deep vein thrombosis 6% |
| Spiliopoulos et al. 2015 (51) | 4 | Prospective case series (n = 60; 74 extremities) | Incompetent GSV and SSV | ERA w/ tumescent anesthesia | 1 session | CEAP Classification (C0 clinical best - C6 clinical worst) VCSS Revascularization rate |
Clinical success: 94.6% improvement Baseline: 72.9% C2-C3 At 1 year: 12.1% C2-C3 VCSS: baseline: 6.2±2.6 1 month: 1.3±1.2 1 year: 0.9±1.4 P<0.0001 Revascularization rate 12.1% |
Not reported | Puncture site infection 1 pt Transient paresthesia 2 pts Puncture site scar 2 pts Skin pigmentation 1 pt |
| Tolva et al. 2012 (52) | 4 | Case series (n = 407) | Incompetence GSV | ERA w/ spinal anesthesia | 1 session | DUS Occlusion |
Occlusion rate: 100% at 1 week and 6 month follow ups |
Not reported | Thrombophlebitis 3 pt Skin pigmentation 1 pt Paresthesia 1 pt Nonocclusive thrombus 1 pt |
| Tzilinis et al. 2005 (53) | 4 | (n = 421; 490 extremities) | Incompetent GSV and SSV | ERA w/ regional or general anesthesia or tumescent anesthesia | 1 session | DUS Occlusion |
Occlusion rate (1 year): 87% |
Not reported | Not reported, except no hospitalizations for procedure-related complications |
| Vasquez et al. 2007 (54) | 3 | Prospective cohort (n = 499; 682 extremities) | Incompetent GSV | ERA w/ tumescent anesthesia | 1 session | VCSS Occlusion rate Symptoms |
VCSS:
Baseline 8.8 At 1 year 3.6 Occlusion rate at 1 year: 87.1% Symptoms: Pain reduced from 95.7% to 15.2% (p < 0.0001) Edema reduced from 92.4% to 17.0% (p < 0.0001) Stasis ulcers healed at rate of 86% |
Patient satisfaction: 98% | Superficial thrombophlebitis (12%) Ecchymosis (13.1%) Erythema (2.5%) Infection (0.5%) Paresthesia (0.3%) |
| Wagner et al. 2004 (55) | 4 | Retrospective cohort (n = 24; 28 extremities) | Incompetent GSV | ERA w/ general anesthesia | 1 session | DUS Occlusion |
Occlusion rate: 100% at 1 year |
Patient satisfaction at 2 years: 94.5% |
Worsening of leg swelling: 1 pt Localized thrombophlebitis: 2 pts. Acute nonocclusive thrombus extending to the common femoral vein from GSV: 1 pt |
| Weiss et al. 2015 (56) | 4 | Retrospective cohort (n = 934 extremities; ERA n = 398) |
Incompetent GSV and SSV | ERA w/ tumescent anesthesia 1,320nm ND:YAG w/ tumescent anesthesia 810nm Diode (n = 34) |
1 session | DUS Occlusion |
Occlusion at 5 years: RFA 61.7% ND:YAG 84.7% Diode laser 65.7% (P<0.0001) |
Not reported | Not reported |
w/ = with; pt = patient; q = every (i.e. q2 weeks = every 2 weeks); x = times to repeat (i.e. x3 = repeat 3 times)