state-of-the-art laser thermal ablation · pdf filemedical/scientific boards: ... phlebology;...

Robert E. Foster, MD, FACC, FSCAIDirector, BHC Vein Center

Birmingham Heart Clinic, PC

Birmingham, Alabama

State-of-the-Art Laser Thermal Ablation

Speaker’s Bureau:

• Abbott

Trainer Honorarium:

• Endologix

Consultant:

• None

Stockholder:

• None

Grant/Research Support:

• None

Medical/Scientific Boards:

• Medtronic Endovenous Advisory Board

Disclosures

Overview of Endovenous Laser Therapy (EVLT)

• Technique and Device• Success rates as compared to other treatment modalities• Adverse effects of treatment• Serious Complications

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

14MLC 453 US Rev C

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

15MLC 453 US Rev C

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”

19MLC 453 US Rev C

VENACURE* 1470NM LASER

• The 1470 nm laser allows effective vein ablation with the targeted energy of 30-50 joules/cm at a setting of 5-7 watts

• Targets the chromophore of water vs. hemoglobin

• Less Power and energy compared to other lasers

13MLC 453 US Rev C

BEFORE AFTER

Vein Char

Question #1

True or False

The Gold tip on the NeverTouch EVLT catheter increases laser tip contactwith the vessel wall improving the desired thermal injury

False

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. Endovenouslaser treatment of saphenous vein reflux: long-term results. JVIR 2003; 14: 991-996.

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; 14:991–996

Summary of Clinical Efficacy

Rasmussen et al. Randomized clinical trial comparing endovenous laser ablation, radiofrequency ablation, foam sclerotherapy and surgical stripping for great saphenous varicose veins. BJS 2011;98:1079-1087 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, 2013Todd 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

2-8 Weeks

3-6Months

1 Year 5 Years

99.7%98.6%

95.2%

90.0%

94.2%

96.7%

87.9%83.7%

84.0%

86.0%

88.0%

90.0%

92.0%

94.0%

96.0%

98.0%

100.0%

102.0%

Perc

ent

Occlu

sio

n

CLF

EVLA

MOCA

UGFS

• Size of vessel• Possibly, but could effected by Tumescent compression, pullback rate,

tortuosity, wavelength, etc.

• Recent study1

• 1470nm 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

Success Variables

1Atastoy MM, J Vasc Interv Radiol. 2015 Sep;26(9):1347-52

Success Variables

Wavelength:• Comparing 1470 and 980-nm diode lasers1

• Treatment response- 87.2%- 980nm100%- 1470 nm

(p<0.004)• Recanalization at 1 year

• 7 pts. 980nm• 2 pts. 1470nm (p=0.16)

1Lasers in Med Sci 2015;30(5):1583-1587)

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)

2.58 1.60(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)

3.6 2.9(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 ClosureFastTM Catheter was used in this study

Rasmussen Randomized Clinical Trial1***

1. 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

Journal of Surgery Society Ltd., Wiley Online Library, www.bjs.co.uk, March 15, 2011

***Rasmussen Randomized Clinical Trial comparing endovenous

laser ablation, foam sclerotherapy and surgical stripping for great

Saphenous varicose veins

RECOVERY Trial1Radiofrequency 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

1. 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

RECOVERY Trial1: Less Pain


RECOVERY Trial1: Less Tenderness


RECOVERY Trial1: Less Ecchymosis


RECOVERY Trial1: Venous Clinical Severity Score (VCSS)


RECOVERY Trial1: Better Quality of Life


RECOVERY Trial1: Fewer Complications

*9 laser treated limbs experienced sequelae with 14 total events

(P=0.021)


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. 2.5mm2,3

• Male gender3

• Hx of prior thrombosis3

1Ann Vasc Surg. 2014 Oct;28(7)1766-502J Vasc Surg Venous Lymphat Disord. 2014;1:2573Vasc Endovascular Surg.2013 Apr;47(3):207-12


• Skin Burns:• Avoidable with good technique• “Tumescent push" to below 1 cm. • Skip segment• Phlebectomize


• Nerve injury:

Question #2

True or False

To insure closure of the GSV, it is important to beginthe laser ablation less than 2 cm from its origin.

False

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

Robert E. Foster, MD, FACC, FSCAIDirector, BHC Vein Center

Birmingham Heart Clinic, PC

Birmingham, Alabama

State-of-the-Art Laser Thermal Ablation

state-of-the-art laser thermal ablation · pdf filemedical/scientific boards: ... phlebology;...

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