Thermal Techniques: Outcomes and Complications
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1 Thermal Techniques: Outcomes and Complications Meet The Experts: Thermal and Non-Thermal Ablation Techniques Joseph D. Raffetto MD VA Boston HCS, West Roxbury, MA, Harvard Medical School, Boston, MA; Brigham and Women s Hospital ACP Meeting Austin, TX
2 Disclosures No financial disclosures or conflicts of interest
3 Endovenous Ablations Thermal -EVLT (Angiod, Dornier, Biolitec, Sharplan, CoolTouch) -RFA (ClosureFast, Medtronic) -steam and cryotherapy (uncommon will not discuss) Non-thermal -foam non-proprietary -mechanical occlusive chemical ablation (MOCA, ClariVein) -cyanoacrylate glue (Sapheon Venaseal, Medtronic) -UGFS -proprietary microfoam (Varithena, BTG) Liquid sclerotherapy Bootun R et al Phlebology 2016;31:5-14.
4 EVLT Lower wavelength target Hbg (810, 940, 980, and 1064 nm) Higher wavelength target water (1320, 1470, and 1920 nm) As the wavelength increase tissue penetration decreases Radial fibers vs. bare fibers Jacketed fibers
5 Clinical Outcomes and Wavelength 1470 nm (radial) vs. 980 nm (bare tip) -less pain and lower VCSS at 1 mo with 1470 nm 1920 nm vs nm -closure rates lower 1920 nm, less pain bruising, similar VCSS 1320 nm vs. 940 nm -less pain and ecchymosis with 1320 nm Doganci S et al Eur J Vasc Endovasc Surg 2010;40: Mendes-Pinto D et al Int Angiol 2016;35: Proebstle TM et al Dermatol Surg 2005;31:
6 RFA 20 seconds per cycle 120 C Requires tumescent
7 Clinical Outcomes Following Interventions Success of the operation -technical success -durability Improvement in hemodynamics Clinical outcomes (VCSS) Quality of life Recurrences Complications
8 500 patients (580 limbs) Sx VV and GSVi RCT to EVLA, RFA, Foam, Surgery GSV tx and phlebectomy C2-4, primary, SVI, reflux 3 year follow up results Primary endpoint closed or absent GSV Secondary endpoints: recurrences, VCSS, QoL Rasmussen L et al J Vasc Surg: Venous and Lym Dis 2013;1:349-56
9 Patent GSV EVLA 6.8% RFA 7% L&S 6.5% UGFS 26.4% (P 0.01) Rasmussen L et al J Vasc Surg: Venous and Lym Dis 2013;1:349-56
10 Clinical VV Recurrences EVLA 20% RFA 14.9% L&S 20.2% UGFS 19.1% (P=n.s.) Reinterventions EVLA 12.5% RFA 11.1% L&S 15.5% UGFS 31.6% (P 0.01) All Tx groups improved VCSS and QoL Rasmussen L et al J Vasc Surg: Venous and Lym Dis 2013;1:349-56
11 798 patients with CVD (C2-6) 11 UK centers RCT: Surgery, EVLT, Foam All patients with GSV L&S +/- SP All patients with EVLT or Foam, VV foam at 6 wks Primary outcome QoL disease specific and generic at 6 wks and 6 mo Brittenden J et al N Engl J Med 2014;371:
12 Outcomes At 6 Months Primary (QoL) -The AVVQ was worse for foam vs. surgery (P=0.006) -The SF36 mental component worse for foam vs. EVLT (P=0.048) -No differences in physical component of generic QoL Secondary -No differences in VCSS -Complete ablation of GSV better in surgery (78%) and EVLT (82%) vs. foam (43%, P 0.01) Complications (skin lumps and staining) Higher for foam than surgery Brittenden J et al N Engl J Med 2014;371:
13 Evaluates the English literature Most common complications related to EVLT by country -superficial burns -nerve injury -arterio-venous fistulae -deep venous thrombosis -endothermal heat-induced thrombosis (EHIT) -pain -bruising Dexter D et al Phlebology 2012;27 Suppl 1:40-45.
14 EVLT Complications Reported in 12 Countries Dexter D et al Phlebology 2012;27 Suppl 1:40-45.
15 Endothermal Heat Induced Thrombosis (EHIT) EHIT defined as propagated thrombus in the deep system pts tx with RFA (n=2120) or EVLA (n=350) -0.28% EHIT II-IV pts tx with EVLA or RFA 74 (2.4%) EHIT II -EVLA 1.9% -RFA 2.6% (P=0.31) Optimal visualization Increase distance to cm EHIT II LMWH 2 weeks EHIT III-IV treat with AC 3 months VTE 0%-5.7%, generally 1% 1 Marsh P et al Eur J Vasc Endovasc Surg 2010;40: Sadek M. et al J Vasc Surg Venous Lymphat Disord 2013;1:
16 69 patients 87 limbs 90% C2 RCT to ClosureFAST RFA or 980-nm laser of GSV Follow up at 1 and 2 wks and 1 month Primary outcome pain and ecchymosis, AE Secondary outcome VCSS and QoL Almeida JI et al J Vasc Interv Radiol 2009;20:752-9.
17 Post-Operative Pain: VAS Almeida JI et al J Vasc Interv Radiol 2009;20:752-9.
18 Outcomes Significantly less tenderness for RFA (up to 2 wks) Significantly less ecchymosis for RFA (up to 1 mo) No phlebitis or VTE in RFA group VCSS lower for RFA up to 2 wks QoL better for pain and physical for RFA at 2 wks Almeida JI et al J Vasc Interv Radiol 2009;20:752-9.
19 International Endovenous Laser Working Group (IEWG), multicenter, registry 810 and 980 nm diode laser Overall complications 3.3% No motor nerve damage No PE Complications One case of third-degree skin burn (0.1%) Six cases of DVT (0.6%) -five at the SFJ/SPJ (0.5%) -one in a gastrocnemius vein 27 cases of sensory nerve involvement (2.7%) Spreafico G et al Ann Vasc Surg 2011; 25: 71-78
20 67 RFA 64 EVLT EVLT 980 nm All patients given paracetamol (acetominophen, qid) and ibuprofen (tid) Take only as required Shepherd AC et al Br J Surg 2010;97:
21 RFA Requires Fewer Analgesics At 3 days 8 8(9 5) tablets after RFA vs. 14 2(10 7) tablets after EVLA (P = 0 003) At 10 days 20 4(22 6) vs. 35 9(29 4) tablets (P = 0 001) Shepherd AC et al Br J Surg 2010;97:
22 EHIT 0.4% in 2470 limbs treated with RFA EHIT 0% in 252 limbs treated with RFA Anwar MA et al Phlebology 2012;27 Suppl 1: Marsh P et al Eur J Vasc Endovasc Surg 2010;40: Probstle TM et al J Vasc Surg 2008;47:151-6.
23 Conclusions Thermal ablation methods are safe and effective RFA and EVLT both effective at 3 years (VCSS, QoL) EVLT wavelengths with similar long term outcomes, less pain/ecchymosis higher Less pain and ecchymosis with RFA Complications usually are mild and self limiting EHIT and DVT are very low with thermal ablation
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