4/5/2014 Venous Hypertension Secondary to Reflux UCSF Vascular Symposium 204 Aggressive assessment and management are the keys to healing Peter J. Pappas, M.D Professor of Surgery Chariman, Department of Surgery The Brooklyn Hospital Leukocytes with TGF-ß 1 Granules Leukocyte Diapedesis 1
4/5/2014 TGF-ß 1 Release TGF-ß 1 Release 2
4/5/2014 TGF-ß 1 stimulated fibroblasts differentiate into myofibroblasts. RAS Activation RAS Activation Injury Stimulus causes cytokine release And RAS activation with possible Normal wound healing process Senescence development and MMP Synthesis 3
4/5/2014 Treatment Options for Venous Ulcers And Levels of Evidence • Compression Therapy • Vein Surgery – Superficial – Deep Impaired venous ulcer healing process – Perforator • Skin Grafting Compression modalities Compression Rx: Evidence of Efficacy • Cochrane library review – Meta-analysis • Reviewed over 200 studies of Rx of VSU • Conclusions – Overall dataset is relatively poor Circaid – Appears clear that compression is better than no compression in healing VSU – Sustained compression of high strength is better than non-sustained compression Unna Boot Multi layer Bandage Compression Stocking 4
4/5/2014 Healing Rate for 252 Ulcers: UNC Recent Trials of Compression Methods experience 100 Percent healed at: Primary Journal ref % healed % healed 90 # pts P val author group A group B 80 6 weeks 29% Nelson J Vasc Surg 245; 4 layer 67% 4 layer 49% single .009 70 10 weeks 57% 2007;45:134 vs single at 24 wks layer at 24 60 layer wks 16 weeks 75% 50 Nelson Br J Surg 2004 387; 4 layer 92 days 126 days < .05 52 weeks 93% 91:1292 vs short str median for 4 median for 40 layer SS 30 Partsch Vasa 112; 4 layer 62% 4 layer 73% SS at 16 NS 1 amputation 20 2001;30:108 vs short str at 16 wks wks required (0.4%) 10 Franks Wound Rep 156; 4 layer 69% 4 layer 73% SS at 24 NS Regen vs SS at 24 wks wks 0 2004;12:157 0 4 8 12 16 20 24 28 32 36 40 44 48 52 56 Polignano J Wd Care 68; 4 layer vs 74% 4 layer 66% Unna at NS 2004;13:21 Unna at 24 wks 24 wks J Vasc Surg Sept 1999 Weeks of Treatment Healing Rate by Initial Compression and Compliance Ulcer Size 100 90 Percent healed at 10 weeks 80 of Rx: 70 < 5 cm 2 77% 60 5 to 20 cm 2 61% 50 > 20 cm 2 22% 40 < 5 cm 2 30 n = 91 All curves 5 - 20 cm 2 n = 94 20 significant > 20 cm 2 n = 67 difference 10 ( P < .01) 0 2 6 10 14 18 22 26 34 42 52 Mayberry et al. Surgery 1991; 81:575-58 Weeks of Treatment 5
4/5/2014 Wrong Diagnosis: Venous Mimics • Basal or squamous cell • AIDS. carcinoma. Level of Evidence for • Arteriovenous • Rheumatoid, lupus, Venous Ulcer Surgery malformations. scleroderma and other collagen vascular Versus Compression disorders. • Cryoglobulinemia and macroglobulinemia. • Tuberculosis and syphilis. • Burns and insect bites. • Pyoderma gangrenosum. Randomized Clinical Trials For Venous Ulcer Summation Data for Studies Prior to 2000 Surgery Howard et al. The role of superficial venous surgery in the management of Venous ulcers: A systematic review. Eur J Vasc Endovasc Surg. 2008;36: 458-465. 6
4/5/2014 C5-6 Disease - The ESCHAR Trial Barwell et al. Eschar Trial. Lancet 2004; 363: 1854-1859 Barwell JR, Lancet 2004 • Prospective randomized trial – High ligation, stripping, phlebectomy and Compression versus – Multilayer compression bandaging • 500 patients with CEAP 5 and 6 disease – Isolated superficial reflux - 300 (60%) – Mixed superficial / deep reflux - 200 (40%) • Endpoints – 24 week ulcer healing – 12 month ulcer recurrence ESCHAR Trial - Ulcer Healing ESCHAR Trial - Ulcer Recurrence Barwell JR, Lancet 2004 Barwell JR, Lancet 2004 100% 12 month freedom from 100% 90% • recurrence (p < 0.0001) 80% 90% Freedom from Recurrence – Surgery + Compression - 70% 80% 12% % Healed 60% 70% – Compression alone 50% 60% - 28% 40% 50% Four year freedom from 30% 40% Surgery • Recurrence (p<0.01) 20% Surgery 30% Compression 10% 20% – Surgery + compression Compression 31% 0% 10% – Compression alone 0 3 6 9 12 0% 56% 0 3 6 9 12 Months Months • 24 week ulcer healing - 65% in both groups 7
4/5/2014 Effect Of Outflow Obstruction On Ulcer Healing: Ulcer Healing With Surgery NASEPS Registry Data 24 weeks Gloviczki et al. J Vasc Surg 1999;29:489-502. Gloviczki et al. J Vasc Surg 1999;29:489-502. Inadequate Surgical Correction Recurrence Rate With Outflow Obstruction: NASEPS Registry Data • LSV not ligated flush at saphenofemoral junction. • LSV tributaries left intact. • LSV ligated and not stripped. Recurrence at thigh due to Hunterian perforator. • Pelvic vein varicosity. • Neovascularization. Gloviczki et al. J Vasc Surg 1999;29:489-502. Stonebridge et al. Br J Surg 1995; 82: 60-62. 8
4/5/2014 Calf Muscle Pump Dysfunction • Always consider calf muscle pump dysfunction in patients with venous ulcer Clinical Trials Data For Varicose and no evidence of reflux on Veins, Not Ulcer Healing: Stripping duplex examination. and compression versus Endovenous • Important cause of pump Technologies dysfunction is poor ankle range of motion. • Role of physical therapy? Back et al. J Vasc Surg, 1995;22:519-523. History of Venous Surgery CEAP Class 2 and 3 Disease: Primary Varicose Veins • Trendelenburg (1890) GSV ligation upper/mid 1/3 • Homans (1916) - Flush Saphenofemoral ligation • Mayo (1906) - Extraluminal stripper • Babcock (1907) - Rigid intraluminal stripper • Myers (1947) - Flexible intraluminal stripper • 2006 - Endovenous Ablation (Laser / RF) 9
4/5/2014 Mechanism of Action Stripping vs Endovenous RF Ablation Randomized Controlled Trials Lurie et al, J Vasc Surg 2003 Eur J Vasc Endovasc Surg 2005 • RF versus Laser • RF versus Surgery • Prospective, multicenter randomized trial Morrison 2005 Rautio 2002 Almeida 2008 Stripping RF Ablation p Lurie 2005 Goode 2008 n = 36 n = 44 Hinchcliff 2006 Stötter 2006 Ablation @ 1 wk 100% 90.5% • Varisolve Foam vs Surgery/Sclero • Laser versus Surgery Ablation @ 2 yrs 100% 92% Wright 2006 de Medeiros 2005 Return to nl activity 3.89 days 1.15 days .02 Rasmussen 2007 * Foam sclero combined Return to work 12.4 days 4.7 days < .05 Kalteis 2008 with sapheno-femoral Ogawa 2008 ligation vs surgery Global QOL @ 1 wk + 3.7 - 9.2 .001 Darwood 2008 Bountouroglou 2006, 2008 Global QOL @ 4 mo NS 10
4/5/2014 Evolves Trial Venous Clinical Severity Scores Eur J Vasc Endovasc Surg 2005 QoL scores: Immediate and Long-Term Global Quality of Life Scores Eur J Vasc Endovasc Surg 2005 Eur J Vasc Endovasc Surg 2005 11
4/5/2014 Stripping vs Endovenous Laser Ablation Stripping vs Endovenous Laser Ablation Rasmussen et al; J Vasc Surg 2007 Rasmussen et al; J Vasc Surg 2007 14 12.9 • Randomized trial of HL/S 12 12 EVL – High ligation & stripping (HL/S) - 68 legs 10 – Endovenous laser (EVL) - 69 legs 7.7 7.6 8 7 6.9 p < 0.05 • Office based procedures 6 4.347 3.948 – U/S guided tumescent anesthesia 4 – Simultaneous miniphlebectomy 2 • Treatment failure at 6 months 0 Normal Activity Work Pain Medication Cost X 1000 (euro) – HL/S - 2 No significant difference in VCSS, AVVSS, or SF-36 at 3 months – EVL - 3 REACTIV Trial What Endovenous Critics Ignore Michaels et al, Heath Technol Assess 2006 Rasmussen et al; J Vasc Surg 2007 • 246 patients extensive vv and saphenous reflux randomized to • Highly selected population – Conservative measures (n = 122) – 1135 patients screened – Saphenous stripping / phlebectomy (n = 124) – 121 (11%) patients enrolled • HRQoL (SF-6D) at 1 yr significantly better with surgery • Office-based stripping is not standard in North America • Fewer symptoms at 1 year with surgery Symptoms Improved or Absent • Although QoL not different at 3 months, early reduction of bodily pain is important to the patient 90% 80% • Return to work longer than in other series 70% 60% – Cost benefit of € 312 based upon return to work in 7 days 50% Conservative 40% Surgery – Costs equivalent at return to work of 5.2 days 30% 20% 10% 0% Aching Heaviness Itching Swelling Cosmesis 12
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