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Optimal therapy for advanced chronic venous insufficiency . 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 CEAP 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 1 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 .
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Intervention_Physical
duplex US scanning
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Intervention_Physical
SEPS
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Intervention_Physical
saphenous vein ligation and stripping
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Outcome_Other
Efficacy , safety , and durability
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Outcome_Physical
ulcers healed or were significantly improved
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Outcome_Physical
ulcers failed to heal
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Outcome_Physical
recurrent ulceration or skin deterioration
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Outcome_Physical
AVP
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Outcome_Adverse-effects
transient neurologic disorders
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Outcome_Adverse-effects
deep venous thrombosis
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Outcome_Mortality
deaths
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Outcome_Other
durability
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Participant_Condition
advanced chronic venous insufficiency ( CVI )
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Participant_Condition
832 patients stratified by CEAP classification .
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Participant_Condition
92 patients with C4 disease