What might bring a new wavelength for endovenous laser? Lowell S. Kabnick, MD, RPhS, FACS

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What might bring a new wavelength for endovenous laser? Lowell S. Kabnick, MD, RPhS, FACS Division of Vascular and Endovascular Surgery

Faculty disclosure Lowell Kabnick, MD NOTHING TO DISCLOSE

IS 1950nm WAVELENGTH THE FUTURE OF THERMAL VENOUS ABLATION? Division of Vascular and Endovascular Surgery

So what is the Holy Grail? Division of Vascular and Endovascular Surgery

So What Do We Know

Laser side effects Most likely caused by laser induced vein wall perforation with extravasation of blood into the surrounding tissue Perforations are more common with; HSLW, higher power (watts), greater LEEDs Proebstle TM, Gul D, et al. Infrequent early recanalization of greater saphenous vein after endovenous laser treatment. J Vasc Surg 2003;38:511 516. Goldman MP, Mauricio M, et al. Intravascular 1320-nm laser closure of the great saphenous vein: a 6- to 12-month follow-up study. Dermatol Surg. 2004;30:1380-1385. Mundy L, Merlin TL, et al. Systematic review of endovenous laser treatment for varicose veins. Br J Surg 2005;92:1189 1194.

Hemoglobin based wavelengths produce more short term side effects than longer wavelengths Less side effects (pain, bruising) with 980nm than 810nm at the same watts Less side effects (pain, bruising) with 1320nm at 5 watts than at 8 watts Kabnick L. Outcome of different endovenous laser wavelengths for great saphenous vein ablation. J Vasc Surg. 2006 Jan;43(1):88-93. Proebstle TM, Moehler T, et al. Endovenous treatment of the great saphenous vein using a1320 nm Nd:YAG laser causes fewer side effects than using a 940 nm diode laser. Dermatol Surg. 2005 Dec;31(12):1678-83.

EVLT Efficacy and Safety Profile: Benchmark 97-99% efficacy Randomized Control Trials: VCSS scores improved QOL improved Murad et al; J Vasc Surg 2010 Shepherd et al, Br J Surg 2010

WHICH IS MORE IMPORTANT FOR POSTOPERATIVE RECOVERY? LASER WAVELENGTH FIBERS

NYU Pilot Studies Objective: (2006-2012) Observational pilot study -Non randomized, prospective, single center study comparing 810nm, 980nm, 1470nm (AngioDynamics, Latham, NY) With bare-tip Vs NeverTouch (AngioDynamics, Latham, NY)

What Do We Know About Fibers? Bare NeverTouch

Power density Courtesy AngioDynamics

Comparison Groups 7 day Average Pain Score (1-10) T - Test Analysis Mean Difference 95% CI for Difference P - Value 810/BT vs. 810nm/JT 2.013 (1.232, 2.794) < 0.0005 980/BT vs. 980/JT 1.568 (0.988, 2.148) < 0.0005 810/BT vs. 980/BT 0.993 (0.202, 1.784) 0.015 810/JT vs. 980/JT 0.548 (-0.017, 1.113) 0.057 810/BT vs. 980/JT 2.561 (1.881, 3.242) < 0.0005 980/BT vs. 810/JT 1.020 (0.319, 1.721) 0.005 810/JT vs. 1470/JT 0.369 (-0.216, 0.954) 0.213 980/JT vs. 1470/JT -0.179 (-0.607, 0.248) 0.407 980/BT vs. 1470/JT 1.389 (0.790, 1.987) < 0.0005 810/BT vs. 1470/JT 2.382 (1.687, 3.078) < 0.0005

Bruising Scores (1-5) T - Test Analysis Comparison Groups Mean Difference 95% CI for Difference P - Value 980/BT vs. 980/JT 1.108 (0.607, 1.609) < 0.0005 810/JT vs. 980/JT 0.531 (0.090, 0.972) 0.019 980/BT vs. 810/JT 0.577 (0.055, 1.099) 0.031 810/JT vs. 1470/JT 0.484 (0.026, 0.942) 0.038 980/JT vs. 1470/JT -0.047 (-0.481, 0.387) 0.831 980/BT vs. 1470/JT 1.061 (0.545, 1.577) < 0.0005 810/BT vs. 1470/JT 2.382 (1.687, 3.078) < 0.0005

Average 7 Day Pain Score Pain Scores by Fiber Type 5.0 Bare Tip Fibers 4.0 3.0 2.0 1.0 0.0 Jacketed Tip Fibers

Bruising Score Bruising Scores by Fiber Type 3 Bare Tip Fibers 2 1 0 Jacketed Tip Fibers

Laser Covered-tip Vs RF 85 patients completed treatment and follow-up examination Modality # Patients Average Age Female/ Male % Average Length Treated (cm) Average Total J/cm Average Pain Average Bruise Total GSV Closed 980-nm 35 51.57 ± 13.7 F=86% M=14% 27.67 82.34 ± 14.7 0.906 1.21 35 RF 50 56.36 ± 15.4 F=80% M=20% 35.90 N/A 0.804 1.34 50 17

Tissue Perforation Experiment 2012

Factors: 810nm vs. 1470nm diode laser 810nm AngioDynamics Delta Laser at 14 watts, 80 J/cm 1470nm AngioDynamics VenaCure 1470 Laser at 6 watts, 42 J/cm Bare Tip (BT) vs. NeverTouch(JT) Fibers Jacketed Tip (JT) fibers AngioDynamics NeverTouch Fiber

Methods: Setup Kabnick 2012 Porcine tissue bathed in CPDA-preserved sheep s blood 8 mm deep, immersed in water bath at body temperature Tissue Orientation - flat horizontal sheet with fibers parallel in contact with tissue, all immersed in blood Fiber Pullback Modified Volcano pullback device for the targeted speeds

Perforation Test Apparatus Programmable Pull-back Device. Fiber Holder Slide ensures correct orientation of fiber with tissue. Note: Laser aiming beam is shown above without blood so porcine tissue can be seen.

Top photo - 6W 1470nm JT on left, BT on right Samples were frozen & cut in 2cm sections. BT JT 14W 810nm Each cross-section was put under a microscope & Depth of perforation was measured. Depth

Perforation Depth Bare Fiber 80J/cm @ 810nm Average Depth = 1.05mm Jacketed Fiber 80J/cm @ 810nm Average Depth = 0.36mm Measurement taken with Micro Vu Vertex 210 Measuring Center at 21x magnification.

Descriptive Statistics Wavelength 810 nm 1470 nm Fiber Bare (BT) NeverTouch Tip (JT) Bare (BT) NeverTouch (JT) Power 14W 6W LEED 80J/cm 42J/cm Average Perforation Depth 1.054 mm (±0.342) 0.364 mm (±0.255) 0.707 mm (±0.306) 0.197 mm (±0.162) Sample Size 25 24 20 19

Wavelength/Fiber Comparisons Comparison Groups Perforations T - Test Analysis Mean Difference 95% CI for Difference P - Value BT vs. JT (810nm) 0.690 (0.517, 0.863) < 0.0005 BT vs. JT (1470nm) 0.510 (0.351, 0.669) < 0.0005 810 vs. 1470 (BT) 0.347 (0.152, 0.542) 0.001 810 vs. 1470 (JT) 0.167 (0.038, 0.296) 0.013 810/BT vs. 1470/JT 0.857 (0.699, 1.015) < 0.0005

Wavelengths and Fibers Perforations Multivariate Analysis Factors Levels N Mean Difference (mm) P - Value Laser 810 vs. 1470 88 0.2590 < 0.0005 Fiber BT vs. JT 88 0.6095 < 0.0005

Perforation Depth (mm) Wavelength/Fiber Combinations 1.4 1.2 810 to 1470 (BT) BT to JT (810) 810/BT to 1470/JT 1.0 BT to JT (1470) 0.8 0.6 0.4 0.2 0.0 Change in Wavelengthh Change in FIber at 810 Change in FIber at 1470 Change in WL & FIber

Perforation Depth (mm) Wavelength and Fiber Effects 1.4 1.2 1.0 0.8 810 nm Bare Tip 0.6 0.4 0.2 1470 nm Jacket Tip 0.0 Laser Fiber

What is More Important? Wavelength is Important Fiber Type is Important The Type of Fiber seems to be more important than the Laser Wavelength

In Conclusion Water based lasers (1470nm) allow decreased power and J/cm. important Covered Fibers allow decreased power density (less vein perforations). More important.

Sneak Peak at a Trial 1470nm Vs 1920nm Dr Daniel Mendes Division of Vascular and Endovascular Surgery

IS 1920nm WAVELENGTH THE FUTURE OF THERMAL VENOUS ABLATION? Division of Vascular and Endovascular Surgery

Demographics Group 1 1470nm laser Group 2 1920nm laser n = 42 (limbs) n = 48(limbs) No 32 Statistical pts, 24 female, difference 8 male in AGE, 38 CEAP, pts, 28 VCSS, female, and 10 male Saphenous 46 limbs Diameter 55 limbs 41 GSV 48 GSV 5 SSV 7 SSV Mean age 54.3 Mean age 52.2 Division of Vascular and Endovascular Surgery

Power Settings 1470nm 1920nm Power: 10W Power: 5W Division of Vascular and Endovascular Surgery

Operative variables 1470nm 1920nm Operative time (min) 32.9 ± 12.1 25.0 ± 7.9 LEED (J/cm) 24.7 ± 0.8 17.8 ± 0.6 Division of Vascular and Endovascular Surgery

Post-operative variables 1470nm 1920nm Bruising (Ecchymosis) 52.4% 18.7% Induration 38.1% 12.4% Skin burn 0 0 DVT 0 0 Days of use of analgesics 2.4 ± 0.4 1.4 ± 0.2 Division of Vascular and Endovascular Surgery

pre-op 7 day 1 month 3 months CEAP 1470nm 3.4 ± 0.9 3.1 ± 1.3 2.4 ± 1.5 2.3 ± 1.6 1920nm 3.3 ± 0.6 2.3 ± 1.3 2.2 ± 1.4 2.2 ± 1.4 VCSS 1470nm 7.7 ± 2.7 2.2 ± 1.7 1.5 ± 1.4 1.2 ± 0.9 1920nm 7.7± 2.7 2.4 ± 1.4 1.5 ± 1.1 1.4 ± 1.0 Division of Vascular and Endovascular Surgery

Closure Percentage Rates of Treated Segments Laser 1470 nm (n = 42) Laser 1920 nm (n = 48) P value 1 month 96.8% 90.9% P=.06 6 months 96.3% 87.5% P=.03 1 year 94.7% 87.5% P=.05 Division of Vascular and Endovascular Surgery

In Conclusion Yes, 1920nm laser is effective for closing veins Yes, 1920nm laser has a low safety profile Yes, 1920nm laser needs to be optimized Yes, we are in the process of optimizing the energy needed to close a truncal vein Is 1920nm-1950nm the new wavelength Division of Vascular and Endovascular Surgery

lowell.kabnick@nyumc.org