State-of-the-Art Laser Thermal Ablation Robert E. Foster, MD, FACC, FSCAI
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1 State-of-the-Art Laser Thermal Ablation Robert E. Foster, MD, FACC, FSCAI Director, BHC Vein Center Birmingham Heart Clinic, PC Birmingham, Alabama
2 Disclosures Speaker s Bureau: Abbott Stockholder: None Trainer Honorarium: Endologix Grant/Research Support: None Consultant: None Medical/Scientific Boards: Medtronic Endovenous Advisory Board
3 Overview of Endovenous Laser Therapy (EVLT) Technique and Device Success rates as compared to other treatment modalities Adverse effects of treatment Serious Complications
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7 NEVERTOUCH GOLD-TIP FIBER Endovenous Laser Treatment Gold-tip eliminates laser tip contact with vein wall Minimizes perforations of the vein wall that typically result in pain and bruising Gold-tip maximizes ultrasonic visibility 14 MLC 453 US Rev C
8 NEVERTOUCH GOLD-TIP FIBER (CONT.) Glass weld at distal tip of 600 um fiber Results in effective fiber diameter of 905 um Lowers actual power density by 56 percent Net effect is a homogeneous ablation with less focal charring of the vein wall 56% lower power density Gold-tip eliminates laser tip contact with vein wall 15 MLC 453 US Rev C
9 400 UM FIBER PROCEDURE KIT 400 um low-profile fiber allows for simple access and positioning Fits through 21 G needle for easy, atraumatic access For spot welds 19 MLC 453 US Rev C
10 VENACURE * 1470NM LASER The 1470 nm laser allows effective vein ablation with the targeted energy of joules/cm at a setting of 5-7 watts Targets the chromophore of water vs. hemoglobin Less Power and energy compared to other lasers 13 MLC 453 US Rev C
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12 Vein Char BEFORE AFTER
13 Question #1 True or False The Gold tip on the NeverTouch EVLT catheter increases laser tip contact with the vessel wall improving the desired thermal injury
14 VENACURE EVLT TREATMENT THE RESULTS Combined Results for VenaCure EVLT Treatment and Endovenous Laser Treatment: > 3000 GSVs treated with endovenous laser Up to 28 month follow-up > 97% of GSVs have remained closed Bruising & mild/moderate tenderness (< 2 wks) No other minor or major complications Min R, Khilnani N, Zimmet. Endovenous laser treatment of saphenous vein reflux: long-term results. JVIR 2003; 14: Endovenous Laser Treatment of Saphenous Vein Reflux: Long-Term Results Robert J. Min, MD, Neil Khilnani, MD, and Steven E. Zimmet, MD J Vasc Interv Radiol 2003; 14:
15 Percent Occlusion Summary of Clinical Efficacy 102.0% 100.0% 98.0% 96.0% 94.0% 99.7% 98.6% 96.7% 95.2% 94.2% CLF EVLA MOCA 92.0% UGFS 90.0% 90.0% 88.0% 86.0% 84.0% 87.9% 2-8 Weeks 3-6 Months 83.7% 1 Year 5 Years Rasmussen et al. Randomized clinical trial comparing endovenous laser ablation, radiofrequency ablation, foam sclerotherapy and surgical stripping for great saphenous varicose veins. BJS 2011;98: Elias and Raines Mechanochemical Tumescentless Endovenous Ablation: Final Results of the Initial Clinical Trial. Phlebology 2012;27:67-72 Dietzek A. RF Segmental ablation: 5-year data. Annual Symposium on Vascular and Endovascular Issues, Techniques, Horizons (Veith Symposium) New York City; November 19, 2013 Todd KL 3rd, et. al. The VANISH-2 study: a randomized, blinded, multicenter study to evaluate the efficacy and safety of polidocanol endovenous microfoam 0.5% and 1.0% compared with placebo for the treatment of incompetence. Phlebology; 2013 Jul 17
16 Success Variables Size of vessel Possibly, but could effected by Tumescent compression, pullback rate, tortuosity, wavelength, etc. Recent study nm fiber 150 J/cm if less than 20mm and 195 J/cm in larger veins 44 consecutive pts. Mean diameter 16.95mm (range 15-26mm) 98% closure a 1 year 1 Atastoy MM, J Vasc Interv Radiol Sep;26(9):
17 Success Variables Wavelength: Comparing 1470 and 980-nm diode lasers 1 Treatment response- 87.2%- 980nm 100% nm (p<0.004) Recanalization at 1 year 7 pts. 980nm 2 pts. 1470nm (p=0.16) 1 Lasers in Med Sci 2015;30(5): )
18 Rasmussen Randomized Clinical Trial 1*** RF Ablation (n=124*) Endovenous Laser Ablation (n=124*) Ultrasound-Guided Foam Sclerotherapy (n=123*) Vein Stripping (n=123*) Efficacy at 1 year (reflux-free rate) 95.2% 94.2% 83.7% (p<0.001) 95.2% Post Intervention Pain Scores** (1 10) 1.21 (p<0.001) (p<0.001) 2.25 Time to return to normal activities (days) 1 (p<0.001) 2 1 (p<0.001) 4 Time to resume work (days) 2.9 (p<0.001) (p<0.001) 4.3 *n is the number of patients who returned for follow-up **In the 10-day period post-procedure Note: The ClosureFast TM Catheter was used in this study ***Rasmussen Randomized Clinical Trial comparing endovenous laser ablation, foam sclerotherapy and surgical stripping for great Saphenous varicose veins. L. H. Rasmussen, M. Lawaetz, L. Bjoern, B. Vennits, A. Blemings and B. Eklof, Randomized Clinical Trial Comparing Endovenous Laser Ablation, Radiofrequency Ablation, Foam Sclerotherapy and Surgical Stripping for Great Saphenous Varicose Veins. British ournal of Surgery Society Ltd., Wiley Online Library, March 15, 2011
19 RECOVERY Trial 1 Radiofrequency Endovenous ClosureFast catheter versus 980nm Laser Ablation for the Treatment of Great Saphenous Reflux A comparison of the patient experience between those treated with the ClosureFast catheter vs. 980nm endovenous laser Six center, single-blinded randomized trial 69 patients; 87 limbs treated (46 CLF; 41 EVL) Patient follow up at 2, 7, 14, and 30 days after treatment. Almeida JI, Kaufman J, Goeckeritz O, et al. Radiofrequency Endovenous ClosureFAST versus Laser Ablation for the Treatment of Great Saphenous Reflux: A Multicenter, Single-Blinded, Randomized Study (Recovery Study).JVIR; June 2009
20 RECOVERY Trial 1 : Less Pain. Almeida JI, Kaufman J, Goeckeritz O, et al. Radiofrequency Endovenous ClosureFAST versus Laser Ablation for the Treatment of Great Saphenous Reflux: A Multicenter, Single-Blinded, Randomized Study (Recovery Study).JVIR; June 2009
21 RECOVERY Trial 1 : Less Tenderness. Almeida JI, Kaufman J, Goeckeritz O, et al. Radiofrequency Endovenous ClosureFAST versus Laser Ablation for the Treatment of Great Saphenous Reflux: A Multicenter, Single-Blinded, Randomized Study (Recovery Study).JVIR; June 2009
22 RECOVERY Trial 1 : Less Ecchymosis. Almeida JI, Kaufman J, Goeckeritz O, et al. Radiofrequency Endovenous ClosureFAST versus Laser Ablation for the Treatment of Great Saphenous Reflux: A Multicenter, Single-Blinded, Randomized Study (Recovery Study).JVIR; June 2009
23 RECOVERY Trial 1 : Venous Clinical Severity Score (VCSS). Almeida JI, Kaufman J, Goeckeritz O, et al. Radiofrequency Endovenous ClosureFAST versus Laser Ablation for the Treatment of Great Saphenous Reflux: A Multicenter, Single-Blinded, Randomized Study (Recovery Study).JVIR; June 2009
24 RECOVERY Trial 1 : Better Quality of Life. Almeida JI, Kaufman J, Goeckeritz O, et al. Radiofrequency Endovenous ClosureFAST versus Laser Ablation for the Treatment of Great Saphenous Reflux: A Multicenter, Single-Blinded, Randomized Study (Recovery Study).JVIR; June 2009
25 RECOVERY Trial 1 : Fewer Complications (P=0.021) *9 laser treated limbs experienced sequelae with 14 total events. Almeida JI, Kaufman J, Goeckeritz O, et al. Radiofrequency Endovenous ClosureFAST versus Laser Ablation for the Treatment of Great Saphenous Reflux: A Multicenter, Single-Blinded, Randomized Study (Recovery Study).JVIR; June 2009
26 Serious Complications of EVLT Rare, but should be noted and are some are avoidable Endothermal Heat-induced Thrombosis (EHIT): Requiring treatment 9/496 (<2%) 1 Affecting factors:?ablation Distance from junction 2.0 vs. 2.5mm 2,3 Male gender 3 Hx of prior thrombosis 3 1 Ann Vasc Surg Oct;28(7) J Vasc Surg Venous Lymphat Disord. 2014;1:257 3 Vasc Endovascular Surg.2013 Apr;47(3):207-12
27 Serious Complications of EVLT Skin Burns: Avoidable with good technique Tumescent push" to below 1 cm. Skip segment Phlebectomize
28 Nerve injury: Serious Complications of EVLT
29 Question #2 True or False To insure closure of the GSV, it is important to begin the laser ablation less than 2 cm from its origin.
30 Conclusions EVLT is easy to perform, safe and effective Major complications are mostly avoidable with proper technique The higher wavelength (1470 nm) and better tip designs improve performance
31 State-of-the-Art Laser Thermal Ablation Robert E. Foster, MD, FACC, FSCAI Director, BHC Vein Center Birmingham Heart Clinic, PC Birmingham, Alabama
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