Adjunctive Proximal Vein Ligation with Endovenous Obliteration of Great Saphenous Vein Reflux: Does It Have Clinical Value?
Article Outline
The risk of clot extension to the deep venous system or pulmonary embolism following endovenous great saphenous vein (GSV) obliteration is possibly related to the size of the proximal GSV. Some practitioners therefore exclude endovenous GSV obliteration for veins greater than an arbitrary size, starting as little as 15 mm. Others provide adjunctive proximal GSV ligation either routinely, or in selected patients with large veins. The clinical value of adjunctive proximal GSV ligation is unknown.
A survey of either the American Venous Forum or the American College of Phlebology, selected for their pedagogic or long-time experience with endovenous GSV obliteration. Respondent characteristics included obliteration technique (laser, radiofrequency [RF], or foam sclerotherapy), academic status, surgical training, indication for and frequency of adjunctive proximal GSV ligation, and society membership. The incidence of pulmonary embolus (PE) and deep vein thrombus (DVT) was also tallied.
Twenty-one thousand nine hundred sixty-five endovenous GSV obliteration cases were reported, 10,290 with a laser (46.8%), 6,275 (28.6%) with RF, and 5,400 (24.6%) with foam. Only two PEs were reported. Of the 34 patients with DVT, at least 11 had only asymptomatic ultrasound evidence of thrombus extension into the femoral vein, and at least five had only calf vein thrombosis. Comparing ligators (7) with nonligators (15), the only characteristic significantly correlating with adjunctive proximal GSV ligation was whether the respondent had complete general or vascular surgical training; nonsurgeons never ligated the saphenous vein (p < .001). There was no difference between outcomes of ligators and nonligators.
Endovenous obliteration of the GSV poses little risk of PE or DVT, no matter what size the proximal GSV. Although these adverse events may be reduced with adjunctive proximal GSV ligation, the results of this study suggest that adjunctive proximal GSV ligation is superfluous in most patients.
Introduction
Endovenous saphenous vein obliteration with laser, radiofrequency (RF), or sclerotherapy is rapidly replacing high ligation and stripping for the treatment of saphenous vein reflux.1, 2, 3, 4, 5 Initial reports indicate good efficacy and relative freedom from complications. One concern remains the interface between the occluded proximal saphenous vein and the deep venous system, where a pulmonary embolus (PE) or deep vein thrombosis (DVT) could develop without saphenous vein ligation or a formal “crossectomy.”
The reported incidence of PE and DVT with endovenous obliteration of the saphenous vein is as high as 7.7% with a laser, and 16% with RF.6, 7 The true incidence is unknown, but if clinically significant PE or DVT occurred that frequently, experienced practitioners might choose to ligate the proximal saphenous vein prophylactically in individuals deemed to be at high risk for these complications.
This study was designed to survey the practices of a spectrum of experienced phlebologists to determine the incidence of adjunctive saphenous vein ligation, characterize the circumstances whereby individual practitioners thought it might be beneficial, and establish whether the procedure has clinical value.
Methods
A 12-question survey was sent to 24 selected members of either the American Venous Forum or the American College of Phlebology, each of whom had an experience of at least 100 endovenous great saphenous vein obliterations for reflux. Those chosen to receive the survey came from various medical subspecialties. Other criteria for inclusion included one or more of the following: publication of a case-series, hands-on training of other physicians, full or associate professorship, or greater than 5 years experience with endovenous saphenous vein obliteration techniques.
The survey questions are listed in Table I. Respondents were not asked to correlate any given complication either with a specific preprocedure morphologic condition or whether the great saphenous vein was ligated in that individual. Many respondents, however, volunteered information to clarify their experience with the issues discussed in the survey. Selected comments are incorporated into the report of results.
Table I. Questionnaire sent to 24 practitioners
1. Have you had formal surgical training? |
| 2.Your current favored technique of endovenous great saphenous vein (GSV) closure is with laser? VNUS? Foam? |
| 3. Who does your preprocedure ultrasound, you or a technician? |
| 4.Do you exclude some patients from treatment with endovenous obliteration alone (i.e., without adjunctive proximal high ligation or other surgical intervention?). (If your answer to this question is “no,” then skip questions 5-9.) |
| 5.If you do exclude some patients, do you do so on the basis of a large GSV at the saphenofemoral junction? Large aneurysm just distal to the epigastric vessels? Generally large GSV? All the above? Other? |
| 6.Roughly what % of your endovenous GSV patients fall into this exclusion category? |
| 7.The reason for rejecting these patients is manufacturer guidelines? Fear of clot extension into the common femoral vein and/or DVT? Fear of pulmonary embolus? Fear of closure failure? (Include all that apply.) |
| 8.What is your threshold for excluding patients (GSV size in mm)? Do you measure this with the patient standing or supine? |
| 9.If you do exclude some patients from endovenous obliteration alone, do you either treat or refer the patient with high ligation in addition to the GSV obliteration? Conventional or inversion stripping? Other? |
| 10.Roughly how many endovenous GSV obliterations have you done each with laser, foam, and/or VNUS? |
| 11.How many patients have you seen with a pulmonary embolus or clinically significant DVT (such as symptoms of swelling/pain) following endovenous GSV obliteration? |
The requested characteristics and responses of the responders were tallied. The Fisher exact test was used to determine which factors are associated with an individual's decision to perform selective adjunctive saphenous vein ligation with endovenous GSV obliteration. Each individual's personal experience with PE and DVT was also tallied, and the results correlated with his or her practice whether or not to ligate the saphenous vein in selected individuals.
Results
Responses were received from 22 physicians of the 24 surveys sent. The primary specialty of these individuals includes: vascular surgery (9), general surgery (3), obstetrics/gynecology (2), dermatology (5), phlebology (2), and radiology (1). Of the 21,965 reported cases, 10,290 (46.8%) were performed with a laser, 6.275 (28.6%) with RF, and 5,400 (24.6%) with foam. PE (2, or .009%) and clinical DVT (23, or 0.10%) were rare. One practitioner voluntarily reported an individual who had a 22-mm subterminal venous aneurysm that was not ligated and who subsequently experienced a pulmonary embolus. The routine postprocedure Duplex ultrasound showed thrombus in the venous aneurysm, but it was absent 1 week later following documentation of the PE. No other morphologic correlations were volunteered.
Only seven of the 22 physicians ever ligated the proximal great saphenous vein (hereafter referred to as “ligators”), and six of them did so from 2%-8% of the time. The determination to ligate the saphenous vein among these six individuals was usually based on the overall size of the saphenous vein (86%) or its proximal-most subterminal diameter (57%), and ranged from 15-18 mm, although three measured this with the patient standing, and three with the patient supine. One individual routinely ligates the proximal saphenous vein. The reason for vein ligation among the seven ligators was concern for pulmonary embolus (86%), failure of vein obliteration (43%), and/or clot extension into the deep venous system (100%). Only one individual (15%) mentioned manufacturer guidelines. None of the seven ligators ever strips the great saphenous vein.
The various characteristics and results associated with saphenous vein ligators are summarized in Table II. All seven ligators completed vascular or general surgical training. The remaining 15 physicians (including five fully-trained surgeons) neither ligate the saphenous vein nor refer patients to other practitioners for ligation or stripping (p < .005). None of the following was correlated with occasional or routine saphenous veins: membership in the AVF or ACP, academic status, technique used (laser, RF, or foam), or whether the treating physician or a technician performs the screening Duplex. There was no correlation between an individual's decision to ligate the saphenous vein ligation selectively and his or her incidence of either PE or DVT.
Table II. Correlation of practitioner characteristics with GSV ligation
| Characteristic | Nonligators | Ligators | p |
|---|---|---|---|
| Member of ACP | 13/15 (87%) | 4/7 (58%) | 0.27 |
| Member of AVF | 6/15 (40%) | 5/7 (71%) | 0.36 |
| Professorship | 7/15 (47%) | 2/7 (29%) | 0.64 |
| Self ultrasound | 7/15 (47%) | 6/7 (86%) | 0.63 |
| Foam use | 4/15 (27%) | 0/7 (0%) | 0.26 |
| Laser use | 14/15 (93%) | 5/7 (71%) | 0.23 |
| RF use | 6/15 (40%) | 3/7 (43%) | 1.00 |
| Full surgical training | 5/15 (33%) | 7/7 (100%) | <0.005 |
Thirty-four individuals developed DVT, but at least 11 of these were asymptomatic and at least five were only in the calf (volunteered data.) One surgeon each reported a patient with a nonfatal pulmonary embolus. There was no correlation of the incidence of PE and/or DVT with an individual's overall decision whether to ligate the great saphenous vein in selected individuals.
Discussion
Critics of minimally invasive great saphenous obliteration for reflux are convinced there is an increased incidence of pulmonary embolus and deep vein thrombosis compared to conventional high ligation and stripping.6, 7 The original guidelines for RF saphenous vein closure (VNUS Medical Technologies, Inc., San Jose, CA) advised a maximum saphenous vein size of 12 mm.8 Many physicians, however, subsequently reported complication-free success in much larger veins, and today there is no recommended maximum vein size for RF closure. Although laser manufacturer guidelines never recommended a maximum size, some physicians using a laser have accepted a self-imposed limit, beyond which they would either ligate the saphenous vein or not do the procedure.9 In this series, no physician declined to obliterate the saphenous vein endovenously for any reason, although seven practitioners chose to ligate the proximal great saphenous vein as an adjunctive procedure in selected individuals.
The statistical analysis in this study suggests that only fully trained surgeons (but not all) chose to ligate the saphenous vein in selected individuals to prevent postoperative complications. Because the incidence of reported complications is rare among our entire group of surveyed physicians, it would appear that great saphenous vein ligation, even in selected patients, may be a superfluous gesture.
There are obvious drawbacks to this study. The physicians who were selected to respond to this survey may not represent the experienced phlebology community. Furthermore the respondents may have underreported their incidence of complications. To power this study adequately would, however, require many more physicians, and the dilemma of a representative sample would still remain.
Nonetheless, we believe that for patients undergoing endovenous obliteration of the great saphenous vein for reflux, the conclusion that fully trained surgeons are the sole proponents of selective saphenous vein ligation, and that adjunctive saphenous vein ligation is of unproved benefit, is probably valid. A large-scale prospective registry could address this issue more accurately and thoroughly, but such a study is not likely to appear soon.
References
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- . Four-year follow-up on endovascular radiofrequency obliteration of great saphenous vein. Dermatol Surg. 2005;31:129–134
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- Deep venous thrombosis after radiofrequency ablation of the greater saphenous vein: a word of caution. J Vasc Surg. 2004;40:500–504
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- . 940-nm laser for treatment of saphenous insufficiency: histological analysis and long-term follow-up. Photomed and Laser Surg. 2005;23:15–19
The author has received no outside financial support.Presented at the 24th Annual Meeting of the Southern California Vascular Surgical Society, Temecula, California, May 5-7, 2006.
PII: S0890-5096(07)00076-3
doi:10.1016/j.avsg.2006.10.017
© 2007 Annals of Vascular Surgery Inc. Published by Elsevier Inc All rights reserved.
