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CoolTouch Endovenous Laser Ablation (CTEV)

ENDOVENOUS 1064-NM AND 1320-NM ND:YAG LASER TREATMENT OF THE PORCINE GREATER SAPHENOUS VEIN

By: Mitchel P. Goldman, MD; Susan P. Detwiller, MD
 

In multiple studies, closure of the greater saphe­nous vein (GSV) through an endoluminal approach with radiofrequency (RF) or laser energy has proved to be safe and effective. These endovenous occlusion techniques are less invasive alternatives to saphenofemoral ligation and/or stripping and are typically performed under local anesthesia with patients returning to normal activities within 1 to 2 days. RF energy can be delivered through a specially-designed endovenous electrode with microprocessor control to perform controlled heating of the vessel wall, leading to vein shrinkage or occlusion by contraction of vein-wall collagen. Limiting heating to 85°C avoids boil­ing, vaporization, and carbonization of tissues. In addi­tion, heating the endothelial wall to 85°C also heats the vein media to approximately 65"C, which contracts colla­gen. Electrode-mediated RF-energy ablation of vessel walls is a self-limiting process. As tissue coagulates, im­pedance decreases markedly, limiting heat generation.

Lasers that can be used for endoluminal treatment of varicose veins target blood hemoglobin with heat, which is then transferred to vessel walls. Lasers emitting wave­lengths of 500 nm to 1064 nm have been used in this way from both inside the vessels and through the skin. Attempts have been made to optimize the absorption of laser energy by using local hemoglobin absorption peaks at 810, 940, 980, and 1064 nm. Endovenous laser treatment (EVLTT, Diomed Inc., Andover, Mass) allows delivery of laser energy directly into the blood vessel lu­men to produce endothelial and vein-wall damage with subsequent fibrosis. Lasers destroy the GSV thermally. The presumed target for absorption of laser energy is in­travascular red blood cells. However, thermal damage with resorption of the GSV has also occurred in veins emptied of blood. Therefore, direct thermal effects on the vein wall probably also occur. The extent of thermal injury to tissue depends strongly on amount of heat and length of exposure. When veins are devoid of blood, vessel walls rupture.

Using an in vitro study model, Proebstle et al pre­dicted that production of thermal gas by laser heating of blood in a 6-mm tube would result in 6 mm of thermal damage. They used a 940-nm diode laser to treat a GSV with multiple 1 -second pulses at 15 J/cm2. Results of histologic examination of the excised GSV showed thermal damage along the entire treated vein with evi­dence of perforations at the point of laser application (this damage was described as "explosive-like" photodisruption of the vein wall). As 940-nm laser energy can penetrate only 0.3 mm in blood formation of steam bubbles is the probable mechanism of action.

Initial reports have shown that use of endovenous RF energy is effective (96% occlusion at 1-3 years, <1 % in­cidence of transient paresthesia) in short-term treatment of the incompetent GSVK;" Although most patients ex­perience some degree of postoperative ecchymosis and discomfort, no other major or minor complications have been reported.

Our patients treated with EVLT show an increase in posttreatment purpura and tenderness. Most of our patients do not return to complete functional normality for 2 to 3 days-versus the 1 day of "downtime" needed after RF ClosureT (Vnus Medical, Sunnyvale, Calif.) of the GSV. As the anesthetic and access techniques for the two procedures are identical, we believe that non­specific perivascular thermal damage is the probable cause for this increased tenderness. In addition, recent studies have suggested that pulsed laser treatment, with its increased risk for vein perforation, may be re­sponsible for the increase in symptoms occurring with EVLT versus RF-energy treatment.13,16 Slow, uncon­trolled pullback of the catheter is a likely cause of ves­sel-wall overheating and perforation, as even the best surgeon may have some difficulty retracting the fiber at the exact speed needed to maintain vessel-wall heating at 85°C.

In this article, we describe a technique for treating varicose veins-using laser energy at a wavelength ap­propriate for targeting vessel walls directly and using a motorized pullback device and a diffuse-fiber delivery system to control that energy precisely. This technique should prevent damage to surrounding tissue and perforation of vessels.

Materials and Methods
Porcine GSV is remarkably similar to human GSV. In this study, fresh porcine GSVs (8-10 mm in diameter) were placed in normal saline after blood was removed with normal saline flushing. The veins were suspended in a graduated cylinder filled with normal saline. The distal end of the veins was closed with running 5-0 nylon suture, and the veins were filled with normal saline. A 550-um quartz fiber was inserted into each vein and threaded through its entire length. Position of the fiber inside the vein was determined by noting the laser's red aiming beam being emitted from the tip of the catheter. The catheter was connected to a motorized pullback device. The procedure began with starting the pullback for approximately 2 or 3 mm and then turning the laser on at various fluences. A 1320-nm, 33-Hz, 1.2-ms pulsed laser was used in a near-continuous mode at 1W, 2W, 3W, 5W, and 5.5W, and a 1064-nm, 40-Hz, 350-ns pulsed laser was used in a near-continuous mode at 5W, 15W, and 20W. The motorized pullback device was used to withdraw all laser fibers at a rate of 1 mm/s. Immediately after the veins were lasered, they were sectioned and placed in formaldehyde for histopathologic processing and evaluation. All veins were evaluated by a dermatopathologist, who was blinded to the purpose and parameters of the experiment.

Results
The extent of thermal damage to vein walls (millimeters of amorphous amphophilic material) was determined, and the vein-wall layers exhibiting thermal damage were identified. Full-thickness vein-wall damage oc­curred at 5W with the 1320-nm laser and at 20W with the 1064-nm laser.

Discussion
Optical absorption curves show that, at 810, 940, and 1064 nm, the primary absorbing chromophore in a vein is hemoglobin. When a vein is drained of blood and a laser is used at one of these wavelengths, a majority of the laser energy is transmitted through the vessel wall to heat surrounding tissue. The 1320-nm laser is ideally suited for penetrating the small amount of blood re­maining in the vessel, and its energy is much more strongly absorbed in the vessel wall by collagen. Most of the energy is concentrated in the wall for heating and shrinkage. The results of this in vitro study show that the 1320-nm Nd:YAG laser may be ideally suited for en-dovascular laser destruction of the GSV.

Extent of thermal damage to vein walls; vein wall layers exhibiting thermal damage
Wave Lenght/Energy
Thickness of Thermal Damage (Amorphous Ampophilic Material mm)
Vein wall layer exhibiting thermal damage
Thrombosis
1320 nm/1W
Focal damage up to 0.1mm, including hyperchromasia or loss of endothelial nuclei, and subendothelial necrosis
Focally, endothelium and media; valves damaged
No
1320 nm/1.9W
Focal damage up to 0.07mm, including subendothelial necrosis and lack of endothelial nuclei
Focally, endothelium and media; valves normal
No
1320 nm/3W
Minimal damage; posible foca subendothelial damage up to 0.05 mm with mild hyperchromasia of endothelial cells; most areas normal
Equivocal mild and focal damage of endothelium and media; no valves represented
No
1320 nm/5W
Approximately 1.1 mm-0.9 mm continous + approximately 0.2 mm adventitial damage when condensed to remove spaces
Endothelium, media, and adventitia; valves
No damaged
1320 nm/5.5W
0.71 mm
Endothelium, media, and adventitia; valves damaged
No
1064 nm/5W
None
None; no valves represented
No
1064 nm/15W
Posible focal damage up to approximately 0.05, mm, <0.1 mm, including subendothelial necrosis and loss of endothelial nuclei; focal vein-wall disruption associated with red blood cell extravasation and early thrombosis
Valve Normal
Probable early
1064 nm/20W
Full Thickness necrosis extending into adventitia; 0.75 mm; vein-wall disruption
Endothelium, media, and adventitia; valves in nondamaged area are normal
Yes

References

1. Weiss RA. Goldman MP. Controlled radiofrequency-mediated endovenous shrinkage and occlusion. In: Goldman MP, Weiss RA. Bergan JJ, eds. Varicose Veins and Telangiectasia: Diagnosis and Treatment. 2nd ed. St. Louis. Mo: Quality Medical Publishing; 1999:217-224.

2. Goldman MP. Closure of the greater saphenous vein with endoluminal radiofrequency thermal heating of the vein wall in combination with ambulatory phlebectomy: preliminary 6-month follow-up. Dermatol Surg. 2000; 26:452-456.

3. Danielsson G. New treatment options for venous disease: a minimally invasive alternative treatment for patients with superficial venous insufficiency. Scope PhleM Lymphol. 2000;7:126-128.

4. Chandler JG. Pichot O. Sessa C, et al. Treatment of primary venous insufficiency by endovenous saphenous vein obliteration. Vase Surg. 2000;34:201-214.

5. Manfrini S. Gasbarro V. Danielsson G, et al. Endovenous management of saphenous vein reflux. J Vasc Surg. 2000:32: 330-342.

6. Chandler JG, Pichot 0, Sessa C, et al. Delining Ihe role of ex¬tended saphenofemoral junction ligation: a prospective compar¬ative study. J Vase Surg. 2000;32:941-953.

7. Goldman MP, Amiry S. Closure of the greater saphenous vein with endolurminal radiotrequency thermal heating of the vein wall in combination with ambulatory phlebectomy: 50 patients with more than 6-month follow-up. Dermatol Surg. 2002;28:29-31.

8. Rautio Y. Ohinmaa A, Perala J. et al. Endovenous obliteration versus conventional stripping operation in the treatment ol primary varicose veins: a randomized controlled trial with comparison of the costs. J Vasc Surg. 2002;35:958-965.

9. Weiss RA, Weiss MA. Controlled radiofrequency endovenous oc elusion using ;i unique radiofrequency catheter under duplex guidance to eliminate saphenous varicose vein rellux: a 2-year follow-up. Dermatol Surg. 2002;28:38-42.

10. Min RJ. Zimmet SE, Isaacs MN, et al. Endovenous laser treatment of the incompetent greater saphenous vein. J Vasc Interv Radiol. 2001;12:1167-1171.

11. Navarro L. Min RJ, Bone C. Endovenous laser: a new minimally invasive method of treatment for varicose veins-preliminary observations using an 810-nm diode laser. Dermatol Surg. 2001 ;27: 117-122.

12. Weiss RA. RF-media1ed endovenous occlusion. In: Weiss RA. Feied CF, Weiss MA, eds. Vein Diagnosis and Treatment. New York, NY: McGraw-Hill; 2001:211-221.

13. Proebstle TM. Lehr HA, Kargl A, et al, Endovenous treatment of the greater saphenous vein wilh a 940-nm diode laser: thrombotic occlusion after endolurminal thermal damage by laser-generated steam bubbles. J Vasc Surg. 2002;35:729-736.

14. Goldman MP. Endovenous laser treatment of the greater saphenous vein: continuous vs. pulsed treatment. Dermatol Surg. In press.

15. Haines DE, Verow AF, Observations on electrode-tissue interface temperature and effect on electrical impedance during radiofrequency ablation of ventricular myocardium. Circulation. 1990;82:1034-1038.

16. Lavergne T, Sebag C, Ollitrault J, et al. Radiofrequency ablation: physical bases and principles. Arch Mai Coeur Vaiss. 1996;89 (spec 1):57-63.

17. Roggan A, Friebel M, Dorschel K, et al. Optical properties of circulating human blood in the wavelength range 400-2500 nm. J BiomedOpt. 1999:50:523-529.