Introduction: While definitive therapy awaits level I evidence, controversy persists regarding the optimal operation for treatment of advanced chronic venous insufficiency (CVI). We propose a pragmatic approach to the correction or amelioration of venous hypertension resulting from hydrodynamic and hydrostatic venous reflux. We evaluated a strategy of balloon dissection, subfascial endoscopic perforating vein surgery (SEPS) with routine posterior deep compartment fasciotomy, including ligation and stripping of the superficial system, for use when reflux is documented at duplex ultrasound (US) scanning. Methods: This is a cooperative, multicenter, retrospective review of 832 patients stratified by CEAT classification. The series consisted of 300 patients with C4 CVI, 119 patients with C5 CVI, and 413 patients with C6 CVI. A subset of 92 patients with C4 disease were prospectively randomized, and ambulatory venous pressure (AVP) was determined preoperatively and postoperatively. All patients underwent duplex US scanning to document reflux in the deep, superficial, and perforating venous systems. Efficacy, safety, and durability were evaluated over follow-up of I to 9 years (mean, 31/2 years). Uniformity was attempted by adoption of the senior author's protocol and technique through on-site preceptorship in each surgeon's operative theater. Results: This technique interrupted 3 to 14 (mean, 7) incompetent perforating veins per patient. Of the 832 patients undergoing SEPS, 460 (55%) underwent saphenous vein ligation and stripping at the same operation. In 92% ulcers healed or were significantly improved within 4 to 14 weeks. In 64 (8%) patients, ulcers failed to heal or there was no benefit from the operation. Thirty-two patients (4%) experienced recurrent ulceration or skin deterioration at 6 months - 2 years (mean, 15 mo). Repeat SEPS was successful in 25 of these 96 patients, and deep valve repair was successful in 4 patients. In the 92 randomized patients with C4 disease, 41 refused postoperative AVP, leaving 51 compliant patients. The SEPS group (n = 25) had significantly reduced AVP (P < .01) compared with the control group (n = 26). Complications in 825 patients were less than 3% and consisted mostly of transient neurologic disorders (eg , paradysthesia), but deep venous thrombosis occurred in 2 patients, with pulmonary embolus in 1. No operative deaths occurred. Follow-up for 1 to 9 years (mean, 31/2 years) demonstrated durability. Conclusion: The efficacy, safety, and durability of this operative protocol proved beneficial in our clinical experience with 832 patients during 9 years of follow-up. The SEPS subset of randomized patients with C4 disease experienced significant decrease in AVP, objectively supporting the effectiveness of reflux surgery in advanced CVI. Until definitive level I evidence is available, this operative technique is advocated as optimal therapy for CVI.
