The Perplexing Perforator: SEPS, PAPS, nothing The Perplexing Perforator: SEPS, PAPS, nothing? SAVS Postgraduate Course 2008 Bill Marston MD Division of Vascular Surgery University of North Carolina at Chapel Hill Jan 2008

Introduction Incompetent perforating veins have been demonstrated in the majority of patients with severe CVI Class 3 52% Class 4 83% Class 5/6 90% Stuart et al, J Vasc Surg 32:138

Diameter-reflux relationship of perforating veins Sandri et al J Vasc Surg 1999;30:867-75 As diameter enlarges, increasing incidence of outward flow on compression Perforator diameter Incidence of reflux 2.0 mm 10% 2.5 mm 50% 3.0 mm 80% 3.5 mm 4.0 mm 88%

The perforator as gate-keeper to the skin Perforator should only allow inward flow from superficial to deep Competence of valves in perforators critical to protecting superficial tissues from transiently elevated deep venous pressures

Varying viewpoints concerning relevance of perforators Nihilists Minimalists

Critical perforator vein questions What is the definition of a clinically significant incompetent perforator?

Standard definition of IPV is required Position of limb Criteria of reflux Sybrandy et al Standing > 0.3 seconds of reflux Delis et al JVS 2001;33:773 Sitting, leg supported > 0.5 secs of reflux x 3, size > 3.5 mm Stuart et al Seated Any deep to superficial flow Tawes et al Not stated Any reverse flow OR any perforator > 2.5 mm diam

Question #1: definition of a clinically significant incompetent perforator We don’t know Perforators of larger diameter are worse Personal favorite > 3.5 mm diameter at fascia > 0.5 seconds of outward flow

2. When should we attempt to correct perforator incompetence? Whenever they are diagnosed if the patient has significant symptoms Only after correcting other sources of venous insufficiency if limb remains symptomatic

Repair all IPVs Tawes et al J Vasc Surg 2003;37:545 832 patients with IPVs identified and SEPS 55% concomitant saphenous surgery 92% of ulcers significantly improved 4% incidence of ulcer recurrence “Until level 1 evidence is available, SEPS is advocated as optimal therapy for CVI”

How can we separate effect of saphenous surgery from potential effect of perforator ligation? Ablate/Remove superficial system first, then treat IPVs if still necessary

Stuart et al, Edinburgh, UK 62 limbs with superficial and perforator incompetence 21% also demonstrated deep insufficiency Performed superficial surgery only Postop duplex evaluation of perforators 80% of patients with mainstem reflux abolished had no IPVs remaining If mainstem reflux (deep or superficial) remained after surgery, 72% still had IPVs J Vasc Surg 1998;28:834

Stuart et al Most IPVs are found in association with superficial venous reflux Although the presence of IPVs is associated with venous ulceration… many of these may be corrected by saphenous surgery alone J Vasc Surg 2001;34:774

Hemodynamic results when IPVs not ligated Mendes et al, Univ of N. Carolina 24 limbs with both superf and perf incomp IPV defined as > 3mm and >0.5 sec reflux Superficial surgery performed IPVs not ligated APG and Duplex performed pre and post-op * JVS Nov 2003

Mendes et al: Results On post-op Duplex, 71% of IPVs were no longer incompetent after superficial surgery Normal < 2 ml/sec 6.0 2.2 Preop Postop P < 0.001

Venous symptom score decreased significantly after superficial ablation

Randomized trial of SEPS vs conservative treatment Dutch SEPS trial: Wittens et al 200 patients randomized, 97 to ambulatory compression, 103 to SEPS + saphenous surgery when indicated Deep venous insuff present in 55% Mean follow-up 29 months

Conservative group Surgery group Rate of ulcer healing 73% 83% Rate of ulcer recurrence 22% 23% Dutch SEPS trial conclusions: -In selected cases with larger ulcers or longer duration surgery did influence healing and recurrence rates -Overall, SEPS did not influence healing or cure

Question #2 When should we attempt to correct perforator incompetence? Cannot yet answer this question based on available evidence Effect of superficial venous surgery or ablation typically confounds assessment of role of perforator procedures

3. What is the best method of treating IPVs? SEPS PAPS Extrafascial ablation of perforator outflow tract

SEPS

SEPS: Results North American SEPS registry 146 patients, 84% CEAP class 5 or 6 71% concomitant superficial procedures 88% of ulcers healed 1 year after surgery Ulcer recurrence 28% at 2 years 46% in post-thrombotic limbs 20% in limbs with primary valvular incomp Gloviczki et al, J Vasc Surg 1999;29:489

Comparative trials of SEPS vs Linton procedure Pierik et al 39 patients prospectively randomized to SEPS or Linton Linton n=19 SEPS n=20 P value Wound infx 10 (53%) <0.001 Nerve injury 2 (11%) 0.23 Blood loss 170 43 Hosp stay 4 days 1 day

Comparative trials of SEPS vs Linton procedure Sybrandy et al, J Vasc Surg 33:1028-32. Linton n=19 SEPS n=20 P value Ulcer healing 100% at 4 months 85% at 4 months NS Ulcer recurrence 22% at 48 months 12% at 48 months New IPVs 45% at 48 months 42% at 48 months Deep venous insuff increased incidence of new IPVs but not recurrent ulcers

Percutaneous Ablation of Perforators PAPS Percutaneous Ablation of Perforators

RFA perforator ablation US guided access Confirm intraluminal site with impedance 150-350 Ohms Local tumescence Apply energy at 85o to 4 quadrants I min each Withdraw I-2 mm and repeat Fig E. Radiofrequency Catheters

Laser perforator ablation Use 400 micron fiber Micropuncture needle access under US at or just below fascia Aspirate to confirm placement Tumescent anesth Ablate at 14-15 W for 4-5 seconds Withdraw 1-2 mm and repeat

Courtesy Steve Elias, Englewood, NJ Fig A. Catheter/needle at fascia level Courtesy Steve Elias, Englewood, NJ

Courtesy Steve Elias, Englewood, NJ

PAPS - results RFA Lumsden SCVS 34 IPVs treated intravascularly 91% occlusion rate at 3 week f/u visit 2 asymptomatic tibial vein thromboses (6%) Laser Elias et al (submitted) 50 IPVs treated with average 120 j energy per segment 90% occlusion rate at 1 month f/u No significant DVT noted

3. What is the best method of treating IPVs? SEPS Success at perf interruption well established Typically requires OR setup PAPS Early results encouraging Rapid office based procedure Extrafascial ablation 70-80% of IPVs will correct

How can we determine the hemodynamic significance of IPVs? Difficult to determine due to frequency of coexistent superficial and/or deep insufficiency Which perforators require correction in absence of superficial disease? Which perforators should be corrected in the face of uncorrected deep venous insufficiency?

Delis et al: JVS 2001;33:773 Proposed that all perforators that demonstrate reflux are not equal Must look at reflux patterns for hemodynamic importance Diam 3.1 mm

Variability of “incompetent perforators” Diameter 5.8 mm

Consider significance of each IPV in transmitting pressure Potential differentiators Size Reflux velocity and duration Volume flow of reflux

Incompetent perforator in symptomatic patient Size > 4mm High V reflux Size < 4mm Low velocity reflux

Incompetent perforator in symptomatic patient Size > 4mm High V reflux Size < 4mm Low velocity reflux Leave alone unless No other cause of Venous symptoms identified

Incompetent perforator in symptomatic patient Size > 4mm High V reflux Size < 4mm Low velocity reflux Correct IPV reflux Leave alone unless No other cause of Venous symptoms identified SEPS PAPS EF ablation

Incompetent perforator in symptomatic patient Size > 4mm High V reflux Size < 4mm Low velocity reflux Correct IPV reflux Leave alone unless No other cause of Venous symptoms identified SEPS PAPS EF ablation