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. 2010 Apr 1;10(6):1–92.

Table A2: Clinical Cohort Trials of Endovascular Laser Treatment for VV – Ablation of the Great Saphenous Vein.

Author, Year, Country Sites, Operators, Anesthesia Laser Wavelength (λ), Mode, Energy (J/cm) Sample (% Female) Concomitant or Staged Procedures Objective Follow-Up
Barucchello 2009 (64) Italy

  • Multi-center

  • general surgeons

  • local or spinal anesthesia, tumescent anesthesia rarely used

  • 808nm

  • 6-12W power continuous mode

  • variable retraction rate <1 to 3 mm/sec

  • 473 p (% F NR)

  • age range: 70-85 yrs

  • 535 Legs

  • 330 GSV, 65 SSV, 140 other incompetent varices

 Concomitantly peripheral incompetent varices treated with ELA (n=210) or with foam sclerotherapy and stab avulsions (n=250) or stab avulsions only (n=75), incompetent perforators subject to ELT (n=243) surgical interruption or foam sclerotherapy (n=243) Short and mid term safety and effectiveness 3 year
Desmyttere 2007 (72) France

  • 1 outpatient site

  • phlebologists

  • tumescent anesthesia

  • 980nm

  • 10 W power continuous mode

  • Min 50 J/mm for 2-4.5 vein diameter to 120 J/mm > 10 mm diameter

  • 500 p (87% F)

  • Mean age 52.6 yrs

  • 511 Legs

 Concomitant ambulatory phlebectomy in 98% Mid term effectiveness and safety 4 year
D’Othee 2008 (118) United States

  • 1 site

  • interventional radiologists

  • tumescent anesthesia

  • 980nm

  • 13 W power continuous mode,

  • 93 J/cm

  • 112 p (74% F)

  • 112 Legs

  • 41 B-GSV, 1B-SSV, 66 U-GSV, 6 U-SSV)

 NR Feasibility of bilateral ELT with low lidocaine tumescent anesthesia 1 year
Elmore 2008 (71) United States

  • 1 site

  • Outpatient vein clinic

  • Tumescent anesthesia

  • 810nm

  • 12-10 W power at pulsed mode

  • 516 p (74% F)

  • 685 Legs

  • 475 GSV, 32 SSV, 9 other (anterior and posterior accessory GSV, posterior thigh circumflex veins)

 Staged, branch varicosities treated several weeks post op with foam sclerotherapy Safety and effectiveness 1 year

Mean 15.2 months (range: 3-65)
Fernandez 2008 (73) Venezuela

  • 1 site angiography suite

  • 3 interventional radiologists

  • tumescent anesthesia

  • 810nm

  • 14 W power continuous mode

  • 140 J/cm or 70 J/cm

  • 1559 p (81% F)

  • 1985 Legs

  • 1652 GSV, 285 SSV, 40 ALT, 8 PMT

 Concomitant Mueller micro phlebectomy for all refluxing truncal veins Safety and clinical effectiveness 15, 30 months
Hamel-Desnos 2008 (84) France / Switzerland

  • 22 outpatient centers

  • vascular surgeons

  • local tumescent anesthesia

  • 980nm

  • pulse or continuous

  • mean energy density 64 J/cm (GSV) and 65 (SSV)

  • 1422 p (74% F)

  • Median age 57 years (range: 15 – 92)

  • 1703 Legs

  • 1394 GSV + 309 SSV

 Concomitantly associated tributaries treated with phlebectomy and/or sclerotherapy Immediate (1 month) and short term (3 months) outcomes on feasibility, safety, side effects, effectiveness 6 month
Jung 2008 (65) Korea

  • 1 outpatient site

  • surgeon

  • local tumescent anesthesia and spinal for more extensive cases

  • 810nm

  • 12-14 W power continuous mode withdraw rate 1.2 – 2 mm/sec

  • 148 p (59% F)

  • Mean age 51.7 yrs, (range: 18-74)

  • 169 Legs

  • 135 GSV + 41 SSV

 Concomitantly ambulatory phlebectomy Safety and effectiveness 3 month

(mean 5.6 months (range 3 – 13 months)
Knipp 2008 (74) United States

  • 1 site – 3 settings

  • outpatient surgery center (n=231 L), interventional radiology suite (n=48 L), operating room (n=181) – general anesthesia in most cases

  • tumescent anesthesia

  • 810nm

  • 14 W power continuous mode with 1mm/sec pullback for first 100 seconds followed by 2.5 mm/second until 1 cm from skin surface

  • energy density 80.7 J/cm

  • 364 p (95% F)

  • Mean age 50.6 yrs and 51.1 yrs

  • 460 Legs

 Concomitant phlebectomy with stab avulsions Evaluate the mid-term experience of ELT GSV and compare outcomes in those with and without deep venous insufficiency 1 and 2 years
Lu 2008 (70) China

  • 1 site

  • vascular surgeons

  • tumescent anesthesia

  • 810nm

  • 12W power pulsed or continuous mode with pullback rate 1-2 mm/sec

  • 1060 p (60% F)

  • Mean age 56 yrs (range: 23-79)

  • 1186 Legs

 Concomitant ligation GSV and all tributary varices and stab avulsions Effectiveness of ELT for GSV reflux and tributary varices 12 months

mean 27 (range: 12-48)
Mackenzie 2008 (66) United Kingdom

  • 1 site

  • vascular surgeons

  • Day case operating suite under general anesthesia (n=119) and later tumescent saline anesthesia only with conscious sedation (n=275)

  • 810nm

  • 12 W pulsed mode with pullback rate 1.4-1.7 mm/sec or 14W continuous mode with pullback rate 1.6–2.0 mm/sec

  • energy density 70-85 J/cm

  • 640 P (66% F)

  • Median age 51 yrs (IQR 39-61)

  • 713 Legs

  • 579 GSV + 119 SSV + 60? AAGSV

 Refluxing truncal veins treated concomitantly or staged with foam sclerotherapy at 3 months Trends, issues and early outcomes in delivering the new service 3 months
Marston 2008 (119) United States

  • 1 site

  • vascular surgeons

  • tumescent anesthesia

  • 810nm

  • 14 W power with pullback rate 5-6 seconds per cm to

  • energy density 70-80 J/cm

  • 75 p (71% F)

  • Average age 57 yrs

  • 75 Legs

 No incompetent perforator veins were treated Evaluate outcomes in patients with and without deep venous reflux Median: 13.1 months
Myers 2009 (75) Australia

  • 1 site outpatient center

  • surgeon

  • tumescent anesthesia

  • 810nm

  • 14 W power on continuous mode with pullback rate 1.3-8.8 mm/sec

  • 361 p (64% F)

  • Median age 52 yrs (range: 24-76)

  • 509 Legs

  • 509 GCV

 Staged 1 -3 weeks ultrasound guided sclerotherapy for residual varices (for 80%) Medium term results 4 year
Pannier 2009 (85; 120) Latvia

  • 1 outpatient phlebology center

  • NR

  • tumescent anesthesia

  • 1470nm

  • 15 W power continuous mode

  • energy density 129 J/cm

  • 100 p (82% F)

  • Mean age 45 yrs (range: 17-77, SD 12.6)

  • 117 Legs

  • 108 GSV + 26 SSV

 Concomitant phlebectomies (97.4% cases) Immediate results and short term complications and effectiveness of 1430nm laser 1 year
Park 2009 (86) Korea

  • 1 site angiography suite

  • interventional radiologists (referrals from vascular, thoracic and cardiovascular surgery outpatient clinics)

  • NR

  • 980nm

  • 8-12 W power on SSV and 10-14W power on GSV

  • energy density 107 J/cm (GSV)

  • 312 p (55% F)

  • Mean age 45.8 yrs (range: 21-71)

  • 438 Legs

  • 331 GSV, 106 SSV

 Foam sclerotherapy of tributaries prior to ELT Technical feasibility and early results 6 months
Prince 2008 (121) United States

  • 1 outpatient clinic

  • 5 interventional radiologists

  • tumescent anesthesia

  • 980nm

  • 12 W power continuous mode variable pullback rate

  • Mean energy density 83.8 J/cm ± 34.4

  • 474 p (79% F)

  • Average age 49 yrs (range: 21-85)

  • 586 Legs

  • 365 GSV, 49 SSV, 60 other V

 Concomitant foam sclerotherapy in 71 patients (46%). 57 patients with bilateral disease had staged treatment - second leg treated at least one month after first Compare failure rates with delivered laser energy density level Mean 5 months (range: 0.2 – 26.3)
Sadik 2007 (87) United States

  • 1 site

  • NR

  • local anesthesia tumescent anesthesia

  • 810nm

  • 14 W power continuous mode with 1-2 second pullback rates

  • Energy density 28J/cm

  • 90 p (76% F)

  • Mean age 40 yrs (range: 24-79)

  • 94 Legs

  • 94 GSV

 Concomitant ambulatory phlebectomy of associated truncal varices Outcomes and recurrence at long term follow up 4 year
Tan 2009 (67) Singapore

  • 1 site operating theatre

  • 2 vascular surgeons

  • general anesthesia

  • 940nm

  • 169 p (66% F)

  • Mean age 54 yrs (range: 19-78)

  • 270 Veins

 ELT was with and without ligation of perforators Short term outcomes 1 year
Theivacumar 2008 (122) United Kingdom

  • 2 sites (venous clinics)

  • NR

  • tumescent anesthesia

  • 810nm

  • 12W power pulse mode

  • 582 p (65% F)

  • Median age 50 yrs (range: 16-86)

  • 644 Legs

 Staged foam sclerotherapy offered at 6 weeks for residual varicosities Assess factors including energy density that influence effectiveness Minimum 3 month
Theivacumar 2008 United Kingdom

  • 1 site (venous clinic)

  • NR

  • Tumescent anesthesia

  • 810nm

  • 12 W power pulse mode

  • 73 p (58% F)

  • 84 Legs

  • 84 GSV

 NR Determine association of vessel recanalization with loss of clinical benefit 1 year
Timperman 2007 United States

  • 1 site (angiogr. suite)

  • interventional radiologist

  • tumescent anesthesia

  • 810nm

  • 14 W power continuous mode with pullback rate 6-9 mm/sec mean

  • Energy density 82 J/cm (range 56-114)

  • 44 p (68% F) from 576 consecutive patients

  • Mean age 53 (range: 26-82, SD 15)

  • 50 Legs

 NR Evaluate clinical failure and untreated incompetent below the knee GSV 1 year
van den Bremer 2009 (68) Netherlands

  • 1 site (community hospital)

  • 3 surgeons

  • general or spinal anesthesia with tumescent anesthesia

  • 980nm

  • 15W power continuous mode with pullback speed

  • Energy density 50 J/cm.

  • 323 p (91% F)

  • Mean age 45.1 yrs (range: 16-74)

  • 403 Legs

 Concomitant hook phlebectomy (Mueller’s method) for varices and saphenous tributaries Results following the start of a new service 6 weeks
Vuylsteke 2008 (88) Belgium

  • 1 site

  • vascular surgeon

  • general or spinal anesthesia with tumescent anesthesia

  • 980nm

  • 10 W pulse mode (7 W below the knee)

  • mean energy density 51 J/cm ± 17

  • 97 p (74% F)

  • Mean age 50 yrs (range: 23-79)

  • 129 Legs

  • 129 GSV

 Concomitant foam sclerotherapy and limited phlebectomy Measure relationship between energy fluence and recanalization 6 months