Incompetent Perforator Vein Treatment in Chronic Venous Insufficiency. Ruth L. Bush, M.D., M.P.H. Florida Vascular Society May 2013

Transcription

1 Incompetent Perforator Vein Treatment in Chronic Venous Insufficiency Ruth L. Bush, M.D., M.P.H. Florida Vascular Society May 2013

2 Disclosures Consultant and proctor for Covidien, Inc. (VNUS) Views expressed do not necessarily reflect the position or policy of the Dept. of Veterans Affairs or the United States government

3 Treatment of Active Venous Ulcer Generally at the malleolar region Hypersensitivity Needs compression to heal (decrease edema) Antibiotic: decrease surface bacteria Slow healing, high recurrence rates

4 Conventional Treatment Layered compression dressings 70% healing at 6 months; 25% recurrence at 1 year ~ 1% of healthcare budgets, public health issue Gloviczki P, Gloviczki ML., Perspect Vasc Surg Endovasc Ther Dec;21(4):259 68

5 ESCHAR Trial Effect of Surgery and Compression on Healing and Recurrence Study 500 patients with chronic venous ulcers randomized to venous surgery or compression alone Stripping and phlebectomy 65% healing at 24 weeks Recurrence rates were decreased by ½ in surgery group Lancet 2004 ; 363: On 4 year follow up Ulcer recurrence remained significantly lower for the surgery group. 31% vs. 55% BMJ 2007:363;1854 9

6 The ESCHAR trial establishes a 1A recommendation that ligation and stripping of the GSV is associated with the prevention of ulcer recurrence. Based on the RCTs and results of studies with surrogate endpoints of restoring perforator competence, the current role of ICPV treatment can be graded as a 2B recommendation. O Donnell, Phlebology 2010;25:3 10

7 To decrease recurrence of venous ulcers, we recommend ablation of the incompetent superficial veins in addition to compression therapy. For treatment of the incompetent great saphenous vein (GSV) we recommend endovenous thermal ablation (radiofrequency or laser) over high ligation and inversion stripping of the saphenous vein to the level of the knee. We recommend against selective treatment of perforating vein incompetence in patients with simple varicose veins (CEAP class C2), but we suggest treatment of pathologic perforating veins (outward flow 500 ms duration, vein diameter 3.5 mm) located underneath healed or active ulcers (CEAP class C5 C6).

8 CVI: Issues in General Goal is to heal ulcer Decrease venous hypertension GSV, VV, Perforators Do you need to treat all veins always? How low is low enough? Anatomic ablation vs. clinical success

9 Perforator Ablation Rationale Reduce superficial venous hypertension Alter microcellular events Leukocyte trapping Cytokine release

10 Perforator Veins Contribution to CVI somewhat controversial Generally agreed to be important in advanced CVI Sometimes important in varicosity recurrence Pattern of initial reflux important determinant of perforator contribution

11 Hemodynamic Studies Following Perforator Ablation Attempts to isolate effect of IPV treatment from that of GSV Hemodynamic effect is surrogate endpoint? Is IPV treatment complementary to GSV ablation O Donnell, Phlebology 2010;25:3 10

12 Treatment Evolution Linton Variants of open surgery >95 years ago, Homan described IPVs as important in tx venous ulcers Homans J Surg Gynecol Obstet 1916;22: Homans J Surg Gynecol Obstet 1917;23: Open surgical approach thru medial calf incision Linton RR Ann Surg 1038; 107: SEPS Subfascial Endoscopic Perforator Surgery Percutaneous Ablation of Perforators Sclerotherapy (liquid or foam)

13 SEPS 1990 s Remote incisions Endoscopic visualization Subfascial ligation clips, harmonic scalpel Outpatient Regional/General anesthesia

14 Endoscopic Instrumentation And Surgical Techniques

15 SEPS Techniques Direct Subfascial Visualization

16 SEPS Advantages vs. Linton Remote incisions low wound complications Less pain Outpatient procedure Visualize pathology Identify more incompetent perforators than pre op (2 3)

17 SEPS Disadvantages Distal perforators unreachable Tight working space Learning curve General/Regional anesthesia Operating Room setting Frustration and incomplete exploration Low adaptation rate by surgeons

18 Percutaneous Perforator Treatment: A Better Way? Percutaneous No incisions Ultrasound guided access Local anesthesia Office based Less expensive Easily repeatable Elias,S. Will SEPS be around in 5 years? IVC Apr. 2005; Miami Fl

19 SEPS Meta analysis 22 case series reviewed for safety and efficacy C5 and C6 patients Results: C6, 90% healing rate C5/6, combined low recurrence rate ~10% Complications: 1% risk DVT Limitations: Data biased by inclusion of limbs with combined GSV and IPV treatment No comparison arm Tenbrook et al. J Vasc Surg 2004:39:

20 Endothermal Ablation Minimally invasive alternative to traditional surgery Faster recovery Fewer complications Laser, radiofrequency

21 RFS Catheter configuration

22

23 Visualize Perforator

24 Duplex Criteria for IPV Enlarged IPV at fascia, 3.5 mm diameter Evidence of high volume, prolonged reversal of flow

25

26 Post Treatment Duplex

27 Benefits of Surgically Correcting CVI Faster healing 140 RFA procedures were (74 superficial; 66 perforators) performed on 110 venous ulcers in 88 limbs Venous ulcers had been present for an average of 71 months Closure success rate of perforators 81% 76.3% of patients ulcers healed at 6 months following RF ablation Harlander Locke et al. The impact of ablation of incompetent superficial and perforator veins on ulcer healing rates, J Vasc Surg 2012;55:458 64

28 Benefits of Surgically Correcting CVI Reduce recurrence 28 RFA procedures (19 superficial; 9 perforators) were performed on 20 patients (21 limbs) 95% of patients previously wore compression stockings for a mean time of 23.3 months Ulcer recurrence rates were 0% at 6 months and 4.8% at 12 months Author compares these recurrence rates to prior studies showing an ulcer recurrence rate up to 67% at 12 months with compression therapy alone Harlander Locke et al. Combined treatment with compression therapy and ablation of incompetent superficial and perforating veins reduces ulcer recurrence in patients with CEAP 5 venous disease, J Vasc Surg 2012;55:446 50

29 356 patients over 2.5 year period 412 venous operations; 56 with bilateral disease) Cohort of 75 patients (21.1%) with severe CVI (C5, C6) Data collected: Body mass index (BMI) History of deep vein thrombosis (DVT) Prior vein surgery Complications Type of procedure: GSV ablation (GSV)or GSV and perforator ablation (GSVP) Primary Endpoints: Ulcer healing time Recurrent ulcerations

30 Treatment Ablation site: GSV GSV + perforator Perforator alone Follow up: Ultrasound 1 week, 6 mos

31 Results: Results 72% had GSV ablated alone; 28% had GSV + perforator C5: 96.2% ulcer free C6: 83.9% ulcer healing in 2.1 ±2.9 mos

32 Results: C5/C6 Comparison C5 n=52 C6 n=31 P value Age (years) 62.0 ± ± 12.9 NS BMI (kg/m 2 ) 33.5 ± ±7.3 NS Gender (M/F) 11/32 13/ GSV/GSVP 31/12 16/9 NS Recurrent or nonhealing ulcer Conclusion: Unclear whether addition of perforator ablation improved healing rates over GSV ablation alone

33 Limitations Small sample size Single center data Low number of perforators procedures Technical expertise with perforator identification was a steep learning curve

34 64 patients with IPV interruption for C5/C6 disease: SEPS n=41 RFA n=23 (plus GSV ablation) 37 month follow up Demographics and risk factors equivalent (BMI, SEPS 29 vs. RFA 31) No significant arterial disease present

35 Results Healing rates (C6 patients) SEPS 88% (n=23) in 5.2 mos RFA 100% (n=12) in 4.4 mos Ulcer recurrence SEPS 17% (n=7) RFA 23% (n=6) p=ns p=ns Complications: no difference, mostly minor Except SEPS: 2 major amputations non healing ulcer, 1 DVT

36 Conclusions

37 Probstle Dermatol Surg 2007;33: (C2 patients) Marks Perspect Vasc Endovasc Surg Endovasc Ther 2008;20: Bacon Phlebology 2009;24:74 78 Van den Bos Phlebology 2009;24: Hingorani J Vasc Surg 2009:50: O Donnell, Phlebology 2010;25:3 10

38 Results Summary % early closure 3 6 months Access with experience 100% Minimal morbidity (2%) Ulcer healing rates acceptable Symptom improvement almost 100%

39 Conclusions Severe chronic venous insufficiency (C5/C6) is common. Endovenous ablation (including perforators) allows for excellent healing rates and acceptable recurrent ulcer rates. Unclear whether the addition of perforator ablation is of benefit in improving venous hemodynamics and ulcer healing rates May want to reserve IPV ablation for recalcitrant or recurrent ulcers.