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450 Radiofrequency treatment of the incompetent saphenous vein
https://t.me/med1917
incidence of neovascularization are no incision and surgical dissection of the groin resulting in angiogenic stimuli and minimal hemodynamic disturbance thanks to preservation of physiologic epigastric ow through the SFJ. Subsequent to RFA, recanalization of the vein is most oen the culprit, but the actual recurrence of SFJ reux is a more objective measure and provides important hemodynamic informa­tion that permits the detection and possible prediction of clinical recurrence. Reux in tributary veins or perforator veins can also cause hemodynamic failure. Clinical fail­ure occurs when symptoms do not resolve or recur, and is usually associated with the reappearance of varicose veins. Varicose vein recurrence rates aer vein stripping have been reported between at 20% and 50% at 2–5 years,
4,4 6–51
and up to 70% of patients have some degree of recurrent symptoms by 10 years.52 However, the varicose vein recurrence rate can be aected by several factors, including the completeness of varicosity removal at the time of initial surgery and the examiner’s subjectivity. Interestingly, 5-year data from the VNUS Closure Registry revealed that hemodynamic failure did not result in symptom recurrence in most patients.28 In a more recent study, however, symptom recurrence (rela­tive risk [RR]: 2.75) and need for additional procedures (RR: 3.96) did correlate with recanalization as identied by duplex, but in the 17 out of 249 limbs with recanalization, no anatomic or patient-specic risk factors were found.
53
37.7 OTHER RF DEVICES
37.7.1 RF-induced thermotherapy
RF-induced thermotherapy (RFiTT; Celon AG, Medical Instruments, Teltow, Germany) is a technique which uti­lizes bipolar RF via resistive heating of the vein wall. In the Laser and RFA Ablation (LARA) study, RFiTT (n = 40) was compared to EVLT with an 810-nm laser (n = 34). Occlusion was 95% in both groups at 10 days and 74% and 78% (P = non-signicant) at 3 months in the ablation and laser groups, respectively. In patients who were their own controls, as they had bilateral disease with one leg treated by laser and other by RFiTT, post-operative pain and bruis­ing were signicantly less in the RFiTT legs in the rst 2
54
weeks.
A much larger prospective, non-randomized, mul-
ticenter study included 462 patients (569 GSVs), with fol­low-up at between 180 and 360 days (mean: 290 ± 84 days). Complete occlusion was accomplished in 98.4% of patients at a mean follow-up of 290 days when experienced operators performed the procedure.
55
37.7.2 F Care Systems: Endovenous RF
Endovenous RF (EVRF; F Care Systems, Antwerp, Belgium) is a monopolar RF device which applies continuous energy for ablation of the saphenous vein using the CR45i catheter at 4 MHz (25 W). In one unpublished, small, prospective,
non-randomized study, 30 patients (54 GSVs) were treated with this technique. At the 1-month follow-up, 92% of patients had complete occlusion, 6% had partial occlusion without reux, and 2% had partial occlusion with reux.56 Szabó (unpublished data) treated 313 patients (276 GSVs) in a single-center, prospective study, with early and mid-term results showing complete occlusion in 99% (275/276) of veins at 1 month. Patient satisfaction was 99% and there were no major complications such as DVT, thermal burns, or nerve
57
injury.
37.7.3 Other endovenous or minimally invasive treatment options
While saphenous RFA combines the benets of a minimally invasive procedure with excellent clinical outcomes, new endovenous modalities continue to challenge RFA as the preferred technique for the treatment of the incompetent, symptomatic saphenous vein. ese include tumescentless mechanochemical endovenous ablation (MOCA), chemical and glue ablations, and higher-wavelength laser bers, cov­ered laser bers, and minimally invasive conventional sur­gical techniques. In one recent small, prospective study of 38 patients using glue—cyanoacrylate embolization (CAE) with the VenaSeal Sapheon Closure System (Sapheon, Inc., Morrisville, NC)—a 92% target vein closure rate was achieved without the need for tumescent anesthesia or post-operative compression stockings. ese outcomes were maintained at the 2-year follow-up.58 A randomized controlled trial published at the time of the writing of this chapter describes the immediate 3-month follow-up results of CAE (n = 108) versus segmental RFA (n = 114). e study showed non-inferiority of CAE to RFA, an adequate safety prole, less peri-procedural ecchymosis, and no need for tumescent anesthesia.59 ere was no statistical advantage to RFA where peri-procedural pain scores were concerned.
MOCA techniques employing the Clarivein Catheter (Vascular Insights, Madison, CT) use mechanical injury to the vein endothelium in combination with an infused liquid sclerosant. Early series have reported decreased pain and bruising with MOCA, with comparative vein occlusion rates to the CLF segmental ablation catheter. More denitive answers as to whether these devices have equal ecacy and decreased pain compared to RFA will come from two randomized trials currently enrolling patients to compare MOCA with segmental RFA. ese are the Mechanochemical Endovenous Ablation versus Radiofrequency Ablation in the Treatment of Primary Great Saphenous Vein Incompetence (MARADONA) study for the GSV62 and the Mechanochemical Endovenous Ablation versus Radiofrequency Ablation in the Treatment of Primary Small Saphenous Vein Insuciency (MESSI) study for the SSV.63 ese two trials are intended to com­pare peri-procedural pain and the ecacy of the MOCA compared with RFA.
60, 61
References 451
https://t.me/med1917
37.8 CONCLUSIONS
One trial compares results with all three major endovenous options (sclerotherapy, laser, and RFA) and conventional
Endovenous ablation is now arguably the standard for the treatment of saphenous vein incompetence. e evidence for the ecacy—both clinical and anatomic—of RFA of the GSV is quite robust and is derived from peer-reviewed journal articles including 14 randomized studies and their respective mid-term follow-up data. Nine of these studies compare RFA to open ligation and saphenous vein strip-
7–15
ping
and ve compare RFA to endovenous laser.
29,37,54,64,65
surgery. e most recent-generation RFA by segmental ablation has been rapidly adopted by clinicians because of its proven e­cacy, short procedure times, and mild patient recovery pro­le as compared to both surgery and EVLT. Although there are now several additional modes of endovenous ablation, none have thus far been as thoroughly evaluated and well studied in the peer-reviewed literature as thermal RFA.
Guidelines 4.9.0 of the American Venous Forum on radiofrequency ablation of the incompetent saphenous vein
No. Guideline
4.9.1 Endovenous thermal ablations (laser and radiofrequency ablations) are safe and effective, and we recommend them for the treatment of saphenous incompetence.
67
4.9.2 Because of reduced convalescence and less pain and morbidity, we recommend endovenous thermal ablation of the incompetent saphenous vein over open surgery.
35
ese data have been systematically reviewed.
recommendation
(1: strong; 2:
67
Grade of
Grade of evidence
B:moderate quality;
weak)
C:low or very low quality)
1 B
1 B
(A:high quality;
33,66
REFERENCES
  ●        
= Major reviews
★  
= Major primary papers
= Clinical practice guidelines
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15. Lurie F, Creton D, Eklöf B etal. Reprinted article “Prospective randomised study of endovenous radiofrequency obliteration (closure) versus ligation and vein stripping (EVOLVeS): two-year follow-up”. Eur J Vasc Endovasc Surg 2011;42(Suppl. 1):S107–13.
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21. Jones RT and Kabnick LS. Perioperative duplex ultrasound following endothermal ablation of the saphenous vein: Is it worthless? J Invasive Cardiol 2014;26(10):548–50.
22. Weiss RA and Weiss MA. Controlled radiofrequency endovenous occlusion using a unique radiofre­quency catheter under duplex guidance to eliminate saphenous varicose vein reflux: A 2-year follow-up. Dermatol Surg 2002;28(1):38 –42.
23. Manfrini S, Gasbarro V, Danielsson G etal. Endovenous management of saphenous vein reflux. J Vasc Surg 2000;32(2):330–42.
24. Lurie F, Creton D, Eklöf B etal. Prospective ran­domised study of endovenous radiofrequency oblit­eration (closure) versus ligation and vein stripping (EVOLVeS): Two-year follow-up. Eur J Vasc Endovasc Surg 2005;29(1):67–73.
25. Goldman MP and Amiry S. Closure of the greater saphenous vein with endoluminal radiofrequency thermal heating of the vein wall in combination with ambulatory phlebectomy: 50 patients with more than6-month follow-up. Dermatol Surg 2002;28(1):29–31.
26. Merchant RF, DePalma RG, and Kabnick LS. Endovascular obliteration of saphenous reflux: A multicenter study. J Vasc Surg 2002;35(6):1190–6.
27. Rautio TT, Perala JM, Wiik HT, Juvonen TS, and Haukipuro KA. Endovenous obliteration with radio­frequency-resistive heating for greater saphenous vein insufficiency: A feasibility study. J Vasc Interv Radiol 2002;13(6):569–75.
28. Sybrandy JE and Wittens CH. Initial experiences in endovenous treatment of saphenous vein reflux. JVasc Surg 20 02;36(6):1207–12.
29. Almeida JI, Kaufman J, Göckeritz O etal. Radiofrequency endovenous ClosureFAST versus laser ablation for the treatment of great saphenous reflux: A multicenter, single-blinded, random­ized study (RECOVERY Study). J Vasc Interv Radiol 2009;20(6):752–9.
30. Merchant RF and Pichot O; Closure Study Group. Long-term outcomes of endovenous radiofrequency obliteration of saphenous reflux as a treatment for superficial venous insufficiency. J Vasc Surg 2005;42(3):502–9; discussion 509.
31. Proebstle TM, Alm BJ, Göckeritz O etal. Five-year results from the prospective European multicentre cohort study on radiofrequency segmental thermal ablation for incompetent great saphenous veins. Br J Surg 2015;102(3):212–8.
32. Calcagno D, Rossi JA, and Ha C. Effect of saphenous vein diameter on closure rate with ClosureFAST radiofrequency catheter. Vasc Endovasc Surg 2009;43(6):567–70.
33. Health Quality Ontario. Endovascular radiofre­quency ablation for varicose veins: An evidence­based analysis. Ont Health Technol Assess Ser 2011;11(1):1–93.
34. Zuniga JM, Hingorani A, Ascher E etal. Short-term outcome analysis of radiofrequency ablation using ClosurePlus vs ClosureFast catheters in the treat­ment of incompetent great saphenous vein. J Vasc Surg 2012;55(4):1048–51.
35. Rasmussen LH, Lawaetz M, Bjoern L, Vennits B, Blemings A, and Eklöf B. Randomized clinical trial comparing endovenous laser ablation, radiofre­quency ablation, foam sclerotherapy and surgical stripping for great saphenous varicose veins. Br J Surg 2011;98(8):1079–87.
36. Proebstle TM, Vago B, Alm J, Gockeritz O, Lebard C, and Pichot O. Treatment of the incom­petent greatsaphenous vein by endovenous radiofrequencypowered segmental thermal ablation: Firstclinical experience. J Vasc Surg 20 08;47(1):151– 6.
37. Shepherd AC, Gohel MS, Brown LC, Metcalfe MJ, Hamish M, and Davies AH. Randomized clini­cal trial of VNUS
®
ClosureFAST radiofrequency ablation versus laser for varicose veins. Br J Surg 2010;97(6):810– 8.
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38. Hingorani AP, Ascher E, Markevich N etal. Deep venous thrombosis after radiofrequency ablation of greater saphenous vein: A word of caution. J Vasc Surg 2004;40(3):500–4.
39. Creton D, Pichot O, Sessa C, and Proebstle TM; ClosureFast Europe Group. Radiofrequency­powered segmental thermal obliteration carried out with the ClosureFast procedure: Results at 1 year. Ann Vasc Surg 2010;24(3):360–6.
40. van Rij AM, Chai J, Hill GB, and Christie RA. Incidence of deep vein thrombosis after varicose vein surgery. Br J Surg 2004;91(12):1582–5.
41. Sharifi M, Mehdipour M, Bay C, Emrani F, and Sharifi J. Effect of anticoagulation on endothermal ablation of the great saphenous vein. J Vasc Surg 2011;53(1):147–9.
42. Corbett CR and Prakash V. Neovascularisation is not an innocent bystander in recurrence after great saphenous vein surgery. Ann R Coll Surg Engl 2015;97(2):102–8.
43. Gad MA, Saber A, and Hokkam EN. Assessment of causes and patterns of recurrent varicose veins after surgery. N Am J Med Sci 2012;4(1):45–8.
44. Kaspar S, Hadzi Nikolov D, Danek T, Maixner R, and Havlicek K. Neovascularisation as a cause of recur­rence after varicose veins operation. Rozhl Chir 2006;85(8):399–403.
45. van Rij AM, Jones GT, Hill GB, and Jiang P. Neovascularization and recurrent varicose veins: More histologic and ultrasound evidence. J Vasc Surg 2004;40(2):296–302.
46. van Rij AM, Jiang P, Solomon C, Christie RA, and Hill GB. Recurrence after varicose vein surgery: A prospective long-term clinical study with duplex ultrasound scanning and air plethysmography. J Vasc Surg 2003;38(5):935–43.
47. Jones L, Braithwaite BD, Selwyn D, Cooke S, and Earnshaw JJ. Neovascularisation is the principal cause of varicose vein recurrence: Results of a ran­domised trial of stripping the long saphenous vein. Eur J Vasc Endovasc Surg 1996;12(4):442–5.
48. Dwerryhouse S, Davies B, Harradine K, and Earnshaw JJ. Stripping the long saphenous vein reduces the rate of reoperation for recurrent vari­cose veins: Five-year results of a randomized trial. JVasc Surg 1999;29(4):589–92.
49. Munn SR, Morton JB, Macbeth WA, and McLeish AR. To strip or not to strip the long saphenous vein? Avaricose veins trial. Br J Surg 1981;68(6):426 – 8.
50. Hammarsten J, Pedersen P, Cederlund CG, and Campanello M. Long saphenous vein saving surgery for varicose veins. A long-term follow-up. Eur J Vasc Surg 1990;4(4):361–4.
51. Kostas T, Ioannou CV, Touloupakis E etal. Recurrent varicose veins after surgery: A new appraisal of a common and complex problem in vascular surgery. Eur J Vasc Endovasc Surg 2004;27(3):275–82.
52. Campbell WB, Vijay Kumar A, Collin TW, Allington KL, and Michaels JA; Randomised and Economic Analysis of Conservative and Therapeutic Interventions for Varicose veins Study. The outcome of varicose vein surgery at 10 years: Clinical findings, symp­toms and patient satisfaction. Ann R Coll Surg Engl 2003;85(1):52–7.
53. Bunnell AP, Zaidi S, Eidson JL 3rd, Bohannon WT, Atkins MD Jr., and Bush RL. Factors associated with saphenous vein recanalization after endothermal ablation. Ann Vasc Surg 2015;29(2):322–7.
54. Goode SD, Chowdhury A, Crockett M etal. Laserand radiofrequency ablation study (LARA study): A ran­domised study comparing radiofrequency ablation and endovenous laser ablation (810 nm). Eur J Vasc Endovasc Surg 2010;40(2):246–53.
55. Braithwaite B, Hnatek L, Zierau U etal. Radiofrequency-induced thermal therapy: Results of a European multicentre study of resistive ablation of incompetent truncal varicose veins. Phlebology 2013;28(1):38–46.
56. Holt D and Lozano R. Saphenous ablation using EVRF radio frequency equipment and catheter CR45i. Initial experience in America. Presented at: XLIII Congress of Vascular Surgery, October 29– November 2, 2011, Aguascalientes, Mexico.
57. Szabó A. Endovenous Saphenous Ablation Using
EVRF Radiofrequency Device and CR45i Catheter. Experience of 313 Cases. Hungary: Semmelweis
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58. Almeida JI, Javier JJ, Mackay EG, Bautista C, Cher DJ, and Proebstle TM. Two-year follow-up of first human use of cyanoacrylate adhesive for treat­ment of saphenous vein incompetence. Phlebology 2015;30(6):397–404.
59. Morrison N, Gibson K, McEnroe S etal. Randomized trial comparing cyanoacrylate embolization and radio­frequency ablation for incompetent great saphenous veins (VeClose). J Vasc Surg 2015;61(4):985 –94.
60. van Eekeren RR, Boersma D, Elias S etal. Endovenous mechanochemical ablation of great saphenous vein incompetence using the ClariVein device: A safety study. J Endovasc Ther 2011;18 (3):3 28 – 34.
61. Elias S and Raines JK. Mechanochemical tumescent­less endovenous ablation: Final results of the initial clinical trial. Phlebology 2012;27(2):67–72.
62. van Eekeren RR, Boersma D, Holewijn S etal. Mechanochemical endovenous Ablation ver­sus RADiOfrequeNcy Ablation in the treatment of primary great saphenous vein incompetence (MARADONA): Study protocol for a randomized controlled trial. Trials 2014;15:121.
63. Boersma D, van Eekeren RR, Kelder HJ etal. Mechanochemical endovenous ablation versus radio­frequency ablation in the treatment of primary small saphenous vein insufficiency (MESSI trial): Study proto­col for a randomized controlled trial. Tria ls 2014;15:421.
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64. Gale SS, Lee JN, Walsh ME, Wojnarowski DL, and Comerota AJ. A randomized, controlled trial of endovenous thermal ablation using the 810-nm wavelength laser and the ClosurePLUS radiofre­quency ablation methods for superficial venous insufficiency of the great saphenous vein. J Vasc Surg 2010;52(3):645–50.
65. Nordon IM, Hinchliffe RJ, Brar R etal. A prospective double-blind randomized controlled trial of radiofre­quency versus laser treatment of the great saphe­nous vein in patients with varicose veins. Ann Surg 2011;2 5 4(6) :876 – 81.
66. Nesbitt C, Eifell RK, Coyne P, Badri H, BhattacharyaV, and Stansby G. Endovenous abla­tion (radiofrequency and laser) and foam sclero­therapy versus conventional surgery for great saphenous vein varices. Cochrane Database Syst Rev 2011;(10):CD005624.
67. Gloviczki P, Comerota AJ, Dalsing MC etal. The care of patients with varicose veins and associated chronic venous diseases: Clinical practice guide­lines of the Society for Vascular Surgery andthe American Venous Forum. J Vasc Surg 2011; 53(5Suppl.):2S–48S.
Laser treatment of the incompetent
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saphenousvein
NICK MORRISON
38
38.1 Introduction 455
38.2 Background 455
38.3 Patient selection 456
38.4 Technology 456
38.5 Procedure 457
38.6 Follow-up 458
38.1 INTRODUCTION
Lower extremity varicose vein disorders are most oen associated with truncal venous insuciency involving the saphenous system: the great saphenous vein (GSV), the small saphenous vein (SSV), and/or incompetent major tributaries or perforator veins. Varicose vein disorders have historically been treated with stripping of the saphenous vein and inter­ruption/ligation and removal of the major tributary and perforator veins.1 Since 1999, endovenous thermal ablation procedures have been found to be safe and eective methods of eliminating the proximal portion of the GSV, the SSV, andeven tributary and perforating veins from the venous circulation, with faster recovery and better cosmetic results tha n strippi ng. monly used to achieve thermal ablation of these incompe­tent veins are: the Venet procedure using a radiofrequency (RF) catheter and generator (Medtronic, Minneapolis, MN); the RF-induced thermotherapy procedure using a bipolar RF system (Celon AF Medical Instruments, Teltow, Germany); the endovenous laser ablation procedure using a laser ber and generator (various manufacturers); and the steam vein sclerosis procedure using heated vaporized water (CERMA SA, Archamps, France). e rst three sys­tems use electromagnetic energy, whereas the last utilizes steam. As with a stripping procedure, following these endo­venous thermal ablation procedures, it is also necessary to treat any remaining incompetent portion of the GSV and/ or SSV, perforating veins, and varicose tributaries, typically
will primarily concern itself with endovenous laser ablation.
2,3
e currently ava ilable methods most com-
4
is chapter
38.7 Outcomes 458
38.8 Perforator vein laser ablation 460
38.9 Summary 461
38.10 Conclusions 461
References 461
38.2 BACKGROUND
38.2.1 Animal studies
ere are no reports of animal testing of laser technology in saphenous vein ablation prior to the initial publication of clinical case series. In 2002, Weiss5 described in vivo cap­rine jugular veins treated with RF and pulsed-mode 810-nm diode lasers, with uoroscopic and histologic examinations demonstrating extensive vein wall damage and frequent perforations with laser ablation compared with RF ablation. Min etal.6 recorded temperatures outside the porcine vein during laser ablation with injected perivenous anesthetic (as is standard for human treatment), and demonstrated temperatures no higher than 40°C within 2 mm of the vein. Later, Fan and Anderson7 treated blood-lled bovine saphenous veins with laser ablation, producing inconsistent transmural thermal damage with perforations, and con­cluded that direct thermal damage is the likely mechanism of vein wall destruction, not steam bubbles as had been pre­viously postulated.
8
38.2.2 Human studies
Prior to the publication of single-center case series reports of endovenous laser ablation of the incompetent saphenous vein, no multicenter clinical trials of the safety and ecacy of this procedure in humans were published. Since the ini­tial published case series, some analyses of the pathophysi­ologic eects of laser ablation in humans have emerged. Proebstle etal.
9
reported on the heat injury seen in a GSV
455
456 Laser treatment of the incompetent saphenousvein
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that was removed following pulsed-mode laser ablation and found damage along the entire vein, noting more severe damage with perforations at the site of the laser pulses. Corcos et al.10 described histopathologic changes in GSVs treated by laser ablation without perivenous anes­thesia, in combination with saphenofemoral interruption and excision of a portion of vein for histologic examina­tion. Full-thickness intimal thermal damage was seen in three-quarters of the veins, with transmural damage and/ or perforation seen in a quarter of the veins. However, sev­eral veins had been subjected to more than one ablation period during treatment, thus limiting the importance of the ndings.
Finally, in an attempt to quantify the risk of thermal damage to surrounding tissue during laser ablation aer injection of perivenous anesthetic, Beale et al.11 measured maximum temperatures of approximately 43°C in tissues 3–5 mm from the GSV during laser ablation. ese ndings were conrmed by Viarengo etal.
12
38.3 PATIENT SELECTION
Inclusion criteria are: symptoms and physical signs of venous disorder; a duplex scan, performed by a fully qualied sonographer, showing a patent vein with reux greater than 0.5 seconds; a patent deep venous system; a vein conducive to cannulation; and adequate patient mobility (Box 38.1).
Exclusion criteria are: arteriovenous malformations; restricted ambulation; acute infection; acute venous throm­bosis13; and deep venous obstruction (Box 38.2).
As a surgeon’s experience with endovenous ablation pro­cedures increases, relative exclusion criteria may be relaxed, and patients with deep venous reux, previous venous treat­ment, large-diameter veins, aneurysmal vein segments, vein tortuosity, or those on chronic anticoagulant therapy14 or
BOX 38.1: Clinical indications for laser
ablation
 ●
Superficial venous disorder
 ●
Duplex scan with reflux >0.5 seconds
 ●
Patent deep system
 ●
Vein conducive to cannulation
 ●
Adequate patient mobility
BOX 38.3: Relative exclusion criteria
 ●
Deep venous reflux
 ●
Previous treatment
 ●
Large-diameter vein
 ●
Anticoagulant therapy
 ●
Hormone-replacement therapy
 ●
Vein tortuosity
 ●
Aneurysmal vein segments
hormone-replacement therapy may be safely and success­fully treated (Box 38.3).
Strong consideration of a thrombophilic condition should be given pre-operatively to patients with a his­tory of deep vein thrombosis, recurrent episodes of acute supercial venous thrombophlebitis, multiple sponta­neous abortions, or a strong family history of deep vein thrombosis or clotting disorders. e physician should be aware of the guidelines produced by the American College of Chest Physicians for the risk assessment for deep vein thrombosis,
15
as these guidelines may be help­ful in selecting patients for laser ablation and in selecting which patients should receive prophylactic anticoagula­tion before undergoing endovenous laser ablation. While the risk of deep vein thrombosis following these proce­dures is low, such a potentially life-threatening outcome following the treatment of relatively benign disease could be catastrophic.
38.4 TECHNOLOGY
Laser generators are available from various manufacturers, all of which appear to be eective at producing venous abla­tion (Table 38.1). Lower-wavelength lasers (up to 1300 nm) target hemoglobin as the primary chromophore. More recently, higher-wavelength lasers have been introduced which target water in the vein wall. Lower levels of energy are thus utilized in these systems, which results in less pain and bruising for patients.
Each generator utilizes a laser ber of varying sizes and designs. Earlier systems used bare-tipped bers, while more recently, covered, centering, or radial bers are more commonly used to reduce the risk of vein perforation and
16,17
BOX 38.2: Exclusion criteria
 ●
Arteriovenous malformation
 ●
Restricted mobility
 ●
Acute infection
 ●
Acute venous thrombosis
 ●
Deep venous obstruction
Table 38.1 Laser generators
Wavelength Name
810 nm Varilase 940 nm Dornier, Angiodynamics 980 nm Angiodynamics 1320 nm 1470 nm
CoolTouch Angiodynamics, Biolitec
38.5 Procedure 457
https://t.me/med1917
subsequent patient bruising and discomfort by producing more uniform vein wall injury.
16–18
38.5 PROCEDURE
Initially, endovenous laser ablation was performed in the hospital surgical or radiologic suite under general anesthe­sia or conscious sedation. However, over the past decade, these procedures have moved to the oce setting under local anesthesia, with or without sedation. Furthermore, although the ablation procedure is oen performed on veins other than saphenous veins, the technical details remain quite similar. e following description of the procedure for a saphenous vein (great or small) is given with the above in mind.
Aer obtaining informed consent, patients may be given an oral or intravenous sedative prior to the proce­dure. e patient is placed on an adjustable operating table (with Trendelenburg capability) in a patient gown and undergarments. e course of the saphenous vein, from the saphenofemoral or saphenopopliteal junction to the insertion site, is mapped by ultrasound. An insertion site is chosen to maximize treatment length, minimize risk of thermal damage to perivenous structures, and assure fac­ile access. Most physicians will utilize a site in the distal thigh or proximal calf for the GSV, and the mid-calf to distal calf for the SSV.
If incompetent, the distal portion of the GSV or SSV saphenous veins are oen not treated with endovenous laser ablation because of the increased risk of paresthesia from damage to the saphenous or sural nerve, which is in close proximity to the vein distally. However, distal thermal ablation is advocated by some investigators to eliminate the entire incompetent segment, with no or minimal increased incidence of nerve damage.19 Access to the saphenous vein is generally gained using an ultrasound-guided, percutane­ously placed needle. Venospasm will make access more dif­cult, so preventative maneuvers such as heating the access site locally, placing the patient in reverse Trendelenburg position, or the use of 2% nitropaste applied to the proposed insertion site prior to the sterile surgical preparation can be utilized to increase the chance of successful venous can­nulation by dilating the vein and preventing venospasm. It is sometimes appropriate to choose a primary access site and a larger-diameter, secondary (back-up) access site in case access at the primary site is unsuccessful. Perivenous or intramural hematoma from unsuccessful attempts at cannulation may render that portion of the saphenous vein technically inaccessible, leading to the need for a secondary site. As the practitioner’s ultrasound-guided technical skills improve, even small-diameter saphenous veins can be suc­cessfully cannulated.
e rst attempt at cannulation of the vein is the most likely to be successful, so the insertion site should be care­fully chosen to make access as ergonomically feasible as possible. Just below the knee, the GSV is relatively anterior. With the patient’s operative leg externally rotated, this site
Figure 38.1 Leg externally rotated with the insertion site
covered with nitropaste.
becomes more advantageous than in the distal or mid-thigh (Figure 38.1). Even though the saphenous nerve is closer to the vein in this area, the laser sheath will protect this por­tion of vein, and thus limit the risk of thermal nerve damage.
e leg is cleansed from the most proximal treatment site to the insertion site with an antiseptic. e operative area is isolated with sterile drapes. Aer inltration of local anesthetic at the insertion site, an introducer needle is inserted into the vein under ultrasound guidance. A micro­insertion set can be used to gain access, and the caliber of sheath “stepped up” to accommodate the laser ber. Using the Seldinger technique, aer placement of a guidewire into the vein, a sheath is advanced into the vein over the guidewire until it is identied by ultrasound to be 3–4 cm below the saphenofemoral junction, or just inferior to the deep angulation of the SSV, where it will join the deep sys­tem. (Alternatively, the laser ber may be advanced directly through the access needle and carefully guided to the same position without the use of the sheath and guidewire.) Occasionally, passage of the ber may be impeded by vein tortuosity. Usually, straightening the leg or guiding the ber by external compression/manipulation of the thigh will enable successful advancement. Segmental stenosis from previous sclerotherapy will also impede advancement of the ber or guidewire. In this case, or if the vein is so tortuous as to not allow passage, a second, more proximal cannulation will enable treatment of rst the proximal and then the distal segments of the saphenous vein.
Ultrasound-guided, high-volume, dilute anesthesia (0.05%–0.25% xylocaine with epinephrine/bicarbonate) is then injected into the saphenous compartment (Figure 38.2) along all but the most proximal portion of the treatment segment, completely surrounding the target vein to ensure adequate anesthetic eect, to compress the vein for better thermal eect, and to protect the perivenous structures from thermal damage. It is always necessary to clearly iden­tify several important anatomic landmarks (Figure 38.3)
458 Laser treatment of the incompetent saphenousvein
FR 4BHz
12:25:38 pm
35 mm
FR 48 Hz
M3
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RS 2D 72%
C 42 P Low Res
P
DN
SS
LA
LF
0
1
2
Figure 38.2 Longitudinal ultrasound image of dilute LA
injected into SS. LA: local anesthesia; SS: saphenous sheath; DN: delivery needle; LF: laser fiber. (Courtesy of D. Neuhardt, Compudiagnostics.)
near the saphenofemoral junction prior to treatment to eect safe and adequate treatment of the GSV. However, one should be mindful that injection of the local anesthetic near the intended start of treatment will obscure these land­marks, severely limiting one’s ability to see the safe nal placement of the laser tip. e patient may then be placed in a Trendelenburg position to further empty the vein of resid­ual blood, with the nal position of the tip of the laser ber conrmed by ultrasound (just inferior to the entrance of the supercial epigastric vein into the GSV—typically 2 cm below the saphenofemoral junction—for GSV treatment [Figure 38.4] and just inferior to the deep angulation of the SSV). e anesthetic solution is then injected into the tissue surrounding the proximal 3–4 cm of the saphenous vein.
e sheath and /or laser ber are then withdrawn at a rate of 1–3 mm per second, more slowly for the proximal 10 cm and more quickly distally. e goal is to achieve successful abla­tion while at the same time minimizing the incidence of vein perforation, which is thought to contribute to post-operative
RS
P
2D
76% C 54 P Low
Re
s
SEV
GSV
x
CFV
Laser fiber tip
2.5
Figure 38.4 Longitudinal image of the saphenofemoral
junction area with an appropriately positioned laser tip in the GSV. SEV: superficial epigastric vein; CFV: com­mon femoral vein; GSV: great saphenous vein; laser tip: tip of the laser fiber just inferior to the entrance of the superficial epigastric vein into the great saphenous vein. (Courtesy of D. Neuhardt, Compudiagnostics.)
pain and bruising. Generally, delivering 60–100 J of laser energy per centimeter of vein treated for lower-wavelength lasers and 40–60 J per centimeter for higher-wavelength lasers will accomplish these goals. On conclusion of the procedure, Doppler conrmation of the patency of the com­mon femoral artery and vein or popliteal artery and vein is recorded. By consensus, patients are generally placed in com­pression therapy (e.g., short-stretch bandages and/or 30–40­mmHg compression hose [thigh high or panty according to patient preference]). Compression is generally maintained for at least several days, if not longer, to minimize patient discomfort.20 Adjunctive ligation of the saphenofemoral or saphenopopliteal junctions is not necessary.
21
38.6 FOLLOW-UP
SEV
CFV
Figure 38.3 Longitudinal ultrasound image of the
saphenofemoral junction area. SEV: superficial epigastric vein; GSV: great saphenous vein; CFV: common femo­ral vein; FV: femoral vein. (Courtesy of D. Neuhardt, Compudiagnostics.)
FV
GSV
15L8w-S
14.0 MHz
Superf. Ven General
70 dB T1/+1/2/4 Gain = 2 dB Δ = 3
Store in progress
LT
e necessity of follow-up duplex examination is not uni­versally accepted.22 However, because of the possibility of incomplete ablation or recurrent patency of the treated vein and the need for adjunctive treatment of the distal GSV and/ or SSV, as well as the incompetent tributaries and perforator veins, color-ow Doppler ultrasound, interviews, and phys­ical examinations at appropriate intervals are suggested to ensure a successful outcome.23 More frequent follow-up vis­its will oen reveal the need for adjunctive treatment earlier in the post-operative course.
38.7 OUTCOMES
38.7.1 Duplex outcomes (surrogateoutcome markers)
Navarro et al.24 published the rst case series in 2001 on 40 veins treated with laser ablation under local perivenous anesthesia, reporti ng 100% complete ablation at a mean follow­up of 4.2months, with no signicant complications. Proebstle
Table 38.2 Mid-term anatomic and clinical outcomes following endovenous laser ablation
https://t.me/med1917
38.7 Outcomes 459
Follow-up
Authors Number of veins
Chang and Chua
Disselhof etal. Nandhra etal. Myers and Jolley
Rasmussen etal.
Samuel etal.
28
38
39
55
29
31
252 19 96.8 36.5% paresthesia
93 24 84 2% thrombophlebitis 44 24 81.2 NA
404 36 80 0.2% severe pain
137 60 82.1 NA
38 60 92.1 2.6% hyperpigmentation
period (months)
etal.25 reported occlusion in all 41 SSVs treated at a mean fol­low-up period of 6 months. Similar short-term reports of suc­cessful ablation with lasers of dierent wavelengths have been published.
26,27
Few mid-term reports are available,28 but most demonstrate similarly good results. In particular, Meyers and Jolley29 have reported their carefully collected and statistically well-analyzed data, showing a secondary or assisted successful ablation rate of 97% at 4 years (Table 38.2).
38.7.2 Patient/physician-reported
outcomemeasures
e movement in clinical trials towards a greater emphasis on quality of life outcome measurement tools is reected in the endovenous laser literature comparing dierent ablation methods. Patient- and physician-reported outcome mea­surement tools are now commonly used to dene successful treatment.
Marston etal.30 reported improved CEAP classication (C, clinical; E, etiology; A, anatomy; P, pathophysiology) and Venous Clinical Severity Score (VCSS) following RF or laser ablation. In reporting 5-year results comparing endo­venous laser with surgical ablation of the GSV, Rasmussen and colleagues noted no statistically signicant dierence in physician- or patient-reported outcome measures.31 Shepherd etal. demonstrated less post-procedural pain fol­lowing segmental RF ablation than with a lower-wavelength laser, but quality of life outcomes were similar at 6 weeks.
Generally good outcomes have been reported when laser ablation is combined with other treatment modali­ties. Mekako et al.33 have demonstrated the feasibility of performing laser ablation in concert with ambulatory phlebectomy. Neglén etal.34 demonstrated good outcomes when combining laser ablation with deep vein stenting for supercial venous insuciency and concomitant deep vein obstruction. eivacumar and colleagues35 have demon­strated that, in some patients, the incompetent GSV in the presence of a grossly incompetent anterior accessory saphe­nous vein will recover competence following ablation of the anterior accessory saphenous vein alone. Myers etal.
36
have
32
Successful
ablation (%) Significant complications
4.8% skin burn
1.6% thrombophlebitis
2.2% thromboembolism
0.3% nerve palsy
2.6% post-procedural pain
advocated for laser ablation for incompetent major tributar­ies, while others have demonstrated the safety and ecacy of laser ablation for the incompetent vein of Giacomini.
37
It has been assumed that most incompletely ablated veins will be seen in the rst few months following treatment. However, we have identied recurrence in our own patients more than 6 years aer apparently successful ablation, with recurrent symptoms and partially patent segments. us, it seems prudent to perform careful follow-up of these patients for 1 year and when recurrent symptoms occur.
Improvement in physician-reported measurement tools such as the revised VCSS and, even more importantly, improvement in patient-reported outcome measures are almost uniformly seen following endovenous laser abla-
31,32,38,39
tion.
Included in many of the more recent laser ablation reports are generic health (Short Form 36 [SF-36] and Euroqol [EQ-5D]) and disease-specic quality of life measurement tools (Aberdeen Varicose Vein Questionnaire [AV VQ ]).
38.7.3 Complications
Complications may be divided into intra-operative and post-operative adverse events. Intra-operative adverse events include technical challenges and adverse patient events (Box 38.4).
e technical challenges sometimes encountered are dif­cult access (venospasm and access location) and problems with advancing the wire/sheath/ber (vein tortuosity, aneu­rysmal segments, or sclerosis from previous sclerotherapy).
BOX 38.4: Intra-operative adverse events
 ●
Difficult access
 ●
Difficult fiber advancement
 ●
Vagal reaction/dysrhythmia
 ●
Nerve pain
 ●
Transient heat