BACKGROUND: Venous leg ulceration (VLU) represents the most advanced form of chronic venous insufficiency (CVI). Persistent VLU that fails to respond to noninvasive treatment requires a minimally invasive endovascular treatment, which may include chemical (ultrasound-guided foam sclerotherapy [UGFS]) and thermal ablation (endovenous laser therapy [EVLT] or radiofrequency ablation [RFA]) targeting incompetent veins. Current guidelines suggest ablation of incompetent perforating veins (IPVs) juxtaposed to active or healed VLU; however, the ideal treatment modality is unknown. We hypothesize that similar to incompetent superficial vein treatment options therapies, VLU healing will be equivalent across minimally invasive IPV treatment options. METHODS: Using the Vascular Low Frequency Disease Consortium, adults with VLU across 11 medical centers were retrospectively reviewed (2013-2017). We included those who underwent IPV therapies. The primary outcome was complete ulcer healing over time compared with cumulative hazard curves, log-rank testing, and multivariable Cox proportional hazard regression. Secondary outcomes included number of subsequent procedures, which were compared using negative binomial regression. RESULTS: Of the 832 adults with VLU, 158 (19%) were exclusively treated conservatively, and 232 (28%) underwent index treatment for IPV and constitute the full and final cohort. The mean age was 60 ± 14 years, 57% were men, and the mean ulcer area was 3.0 cm2 (interquartile range, 1-6 cm2). Ninety-one (39%) were treated with EVLT, 127 (55%) RFA, and 14 (6%) UGFS. Patients treated with RFA were older (RFA 62 ± 14 years; EVLT 59 ± 14 years; UGFS 52 ± 9 years; P = 0.01), more likely to be men (RFA 68%, n = 86; EVLT 41%, n = 37; UGFS 64%, n = 9; P < 0.001), with a higher frequency of anticoagulation (RFA 36%, n = 46; EVLT 18%, n = 16; UGFS 14%, n = 2; P = 0.005). VLU did not significantly differ in size between groups (RFA 6.2 ± 8; EVLT 4.2 ± 5.4; UGFS 6.1 ± 8; P < 0.001). There were no differences in 1-year ulcer healing rates between groups (P = 0.18). The number of subsequent procedures did not differ by treatment modality (P = 0.47). CONCLUSIONS: This multi-institutional retrospective study does not demonstrate any association of IPV treatment modality with differing rates of VLU healing or number of subsequent procedures.
BACKGROUND: Venous leg ulceration (VLU) represents the most advanced form of chronic venous insufficiency (CVI). Persistent VLU that fails to respond to noninvasive treatment requires a minimally invasive endovascular treatment, which may include chemical (ultrasound-guided foam sclerotherapy [UGFS]) and thermal ablation (endovenous laser therapy [EVLT] or radiofrequency ablation [RFA]) targeting incompetent veins. Current guidelines suggest ablation of incompetent perforating veins (IPVs) juxtaposed to active or healed VLU; however, the ideal treatment modality is unknown. We hypothesize that similar to incompetent superficial vein treatment options therapies, VLU healing will be equivalent across minimally invasive IPV treatment options. METHODS: Using the Vascular Low Frequency Disease Consortium, adults with VLU across 11 medical centers were retrospectively reviewed (2013-2017). We included those who underwent IPV therapies. The primary outcome was complete ulcer healing over time compared with cumulative hazard curves, log-rank testing, and multivariable Cox proportional hazard regression. Secondary outcomes included number of subsequent procedures, which were compared using negative binomial regression. RESULTS: Of the 832 adults with VLU, 158 (19%) were exclusively treated conservatively, and 232 (28%) underwent index treatment for IPV and constitute the full and final cohort. The mean age was 60 ± 14 years, 57% were men, and the mean ulcer area was 3.0 cm2 (interquartile range, 1-6 cm2). Ninety-one (39%) were treated with EVLT, 127 (55%) RFA, and 14 (6%) UGFS. Patients treated with RFA were older (RFA 62 ± 14 years; EVLT 59 ± 14 years; UGFS 52 ± 9 years; P = 0.01), more likely to be men (RFA 68%, n = 86; EVLT 41%, n = 37; UGFS 64%, n = 9; P < 0.001), with a higher frequency of anticoagulation (RFA 36%, n = 46; EVLT 18%, n = 16; UGFS 14%, n = 2; P = 0.005). VLU did not significantly differ in size between groups (RFA 6.2 ± 8; EVLT 4.2 ± 5.4; UGFS 6.1 ± 8; P < 0.001). There were no differences in 1-year ulcer healing rates between groups (P = 0.18). The number of subsequent procedures did not differ by treatment modality (P = 0.47). CONCLUSIONS: This multi-institutional retrospective study does not demonstrate any association of IPV treatment modality with differing rates of VLU healing or number of subsequent procedures.
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