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Real-time color duplex scanning after sclerotherapy of the greater saphenous vein
Real-time color duplex scanning after sclerotherapy of the greater saphenous vein Christopher C. R. Bishop, M C h i r , F R C S , Helane S. Fronek, M D , Arnost Fronek, M D , Ralph B. Dilley, M D , and Eugene F. Bernstein, Nil), PhD,
La folla, Calif. A color real-time duplex scanner was used to scan the greater saphenous vein in 89 limbs of 55 patients to study the efficacy of prior greater saphenous vein sclerotherapy. The greater saphenous vein was insonated from the saphenofemoral junction to the knee to evaluate both reflux to a standardized 30 mm Hg Valsalva maneuver and evidence of greater saphenous vein obliteration by sclerotherapy. These data were correlated with the number ofsderosing injections used (mean, 1.8; range, 1 to 6), time from the last injection (mean, 27.5 mo.; range, 3 to 55 mo), and concentration of injectant used (0.5% to 3% sodium tetradecyl sulfate). Fifty-one of 89 injected limbs (57%) demonstrated reflux through the saphenofemoral junction, and reflux down the more distal greater saphenous vein was found in 67 of 89 injected limbs (75%). Greater saphenous vein obliteration was noted in only 18 of 89 injected limbs (20%); two were totally obliterated, and 16 were partially obliterated. The greater saphenous vein was obliterated in 6% below a refluxing saphenofemoral junction and in 40% below a nonrefluxing junction. A greater saphenous vein obliteration rate of 9% was found with a refluxing greater saphenous vein, and 50% in a nonrefluxing greater saphenous vein. Femoral vein reflux was identified in 11 of the 110 limbs (10%) and in every case was associated with both saphenofemoral junction and greater saphenous vein reflux. We noted a trend toward more successful results with more concentrated injectate (3% sodium tetradecyl sulfate). Fifty percent of patients reported improvement in symptoms. We conclude that sclerotherapy of the greater saphenous vein in the presence of saphenofemoral junction or greater saphenous vein reflux is unlikely to remain successful in the long term. These patients require control of the refluxing junction before sclerotherapy. (J Vase SURG 1991;14:505-10.)
Varicose veins are a common problem in humans and are a reflection of the uptight human posture. Fortunately, our understanding of venous pathophysiology has improved since the days when varices were believed to contain "black bile, "~ and varicose veins were attributed to a high melancholy temper in men. 2 Despite our increased knowledge of the origin of varicose veins, the optimum treatment remains controversial. The principle behind successful therapy includes the correct identification of the site of valvular incompetence and the subsequent control of this site by either surgery or injection sclerotherapy. 3-s From the Division of Vascular and Thoracic Surgery, Scripps Clinic and ResearchFoundation, La Jolla. Supported by the Vascular Disease Foundation, La Jolla, Calif. Presented at the Sixth AnnualMeeting of the Western Vascular Society, Palm Springs, Calif.,Jan. 13-16, 1991. Reprint requests: EugeneF. Bernstein,MD, Divisionof Vascular and ThoracicSurgery,ScrippsClinicand ResearchFoundation, 10666 N. Torrey Pines Rd., La Jolla, CA 92037. 24/6/30558
Two randomized studies that compared injection sclerotherap!¢ to surgery concluded that injection sclerotherapy was inferior in the presence of greater saphenous vein (GSV) incompetence. 9"1°Recurrence of varicose veins was related to inadequate control of the saphenofemoral junction, whether treated by surgery or injection sclerotherapy, but the failure rate was greater after injection sclerotherapy alone. An alternative approach for saphenous vein incompetence is ligation of the saphenofemoral junction followed by injection of the varices and the GSV. n Nevertheless, the development of better and more concentrated safe sclerosing agents stimulated us to attempt sclerotherapy alone for a group of patients with varices and GSV incompetence identified by hand-held Doppler examination. This report evaluates the results of this more recent approach. The presence of retrograde flow in veins was first recognized by Trendelenburg, 12 and the Brodie and Trendelenburg test remains the traditional clinical test for GSV reflux. Nabatoff 13 has claimed that 505
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simple inspection and palpation is sufficiently accurate in the detection of sites of valvular incompetence, and O'Donnell et al.,14 in a study comparing Doppler with clinical and phlebographic detection of incompetent perforating veins, showed that only phlebography demonstrated a significant improvement over clinical examination, but this predated the availability of duplex and real-time color imaging ultrasound systems. Descending venography will identify reflux through the saphenofemoral junction and down the GSV, 1~ but it is associated with the morbidity of the procedure26 Therefore an alternative nonlnvasive method of assessing GSV reflux would be welcome. The duplex scanner has been used to evaluate the venous system) 7 It can readily identify reflux in specific veins and can ,be used in conjunction with a Valsalva maneuver?8:~9 Furthermore, t h e duplex scanner has demonstrated a competent saphenofemoral junction in the presence of clinically obvious varicose veins, 2° and the existence of short segments of reflux within an otherwise normal venous system. 18 If Bjordalz~ is correct in suggesting that the main cause of raised venous pressure is the reflux of blood down the GSV, then identification of the precise site of valvular incompetence in patients with varicose veins would enable the selection of the most appropriate method of treatment. This study reports the use of real-time color duplex scanning after injection sclerotherapy of the GSV, to evaluate the efficacy of this therapy. PATIENTS A N D M E T H O D S Fifty-five patients (39 women, 16 men) of mean age 41 years (range, 19 to 67), who had previously undergone injection sclerotherapy of the GSV for symptomatic varicosities, were studied. Thirty-four patients had both GSVs injected, providing 89 limbs for evaluation by duplex scanning. Injection sclerotherapy was performed by the method of Sigg, s using between two and four injections of 0.5 ml Sotradecol (STD) into the GSV. In this method the needle is inserted with the patient in the upright position, and injections are begun in the most distal varicose vein, proceeding proximally. Once the needle is in the varicosity, the patient is then placed in the supine position with the leg elevated to empty the vein. Postinjection compression of the injected site is then maintained for 3 weeks with elastic wraps. Injectant was introduced at 5 cm intervals along the entire course of the GSV from ankle to upper thigh, with special attention to the additional injection of the site of all perforating veins, including the midthigh
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perforation, when present. The concentration of STD ranged from 0.5% to 3%, with most injections of either 1% (45/89) or 3% (23/89). The number of sessions at which the GSV was injected ranged from one to six, with a mean of 1.8. The time from completion of the sclerotherapy treatment to duplex scanning ranged from 3 to 55 months, with a mean of 27.5 months. Duplex scanning was performed with the Quantum QAD-1 Color Duplex Scanner (Quantum Medical Systems, Issaquah, Wash.). A 7.5 MHz probe was used to insonate the GSV from the saphenofemoral junction down to the knee. Reflux was assessed by having the patient perform a standardized Valsalva maneuver by blowing into a mouthpiece connected to a sphygmomanometer and maintaining a pressure. of 30 mm Hg for 5 seconds. Reflux was considered present if reverse flow was seen in the GSV or through the saphenofemoral junction during the whole period of the Valsalva maneuver: Occasionally, reverse flow was present for a second or so before the valves closing, and these instances were reported as competent veins. Evidence o f total or partial obliteration of the GSV was evaluated, as this had been the purpose of the original injection sclerotherapy treatment. RESULTS Fifty-one of 89 injected limbs (57%) demonstrated reflux through the saphenofemoral junction, and reflux down the more distal GSV was found in 67 of 89 injected limbs (75%). Greater saphenous vein obliteration was noted in only 18 of 89 injected limbs (20%); two were totally obliterated, and 16 were partially obliterated along some portion of the length of the GSV. Both the GSVs that were totally, obliterated were below a competent saphenofemoral junction, and 13 of 16 partially obliterated GSVs were below a competent GSV. Therefore relating GSV obliteration to the status of the ipsilateral saphenofemoral junction resulted in a GSV obliteration rate of 40% (15/38) if the saphenofemoral junction was competent and a GSV obliteration rate of 6% (3/51) if the saphenofemoral junction demonstrated reflux. In the 16 GSVs that were partially obliterated, the remaining "open" portion of the GSV was normal in 10 and refluxed in six. Ten partially obliterated GSVs were associated with a normal (nonrefluxing) GSV, giving an obliteration rate of 50% (10/20), whereas if the GSV refluxed, the obliteration rate was only 9% (6/67). In 18 limbs the GSV was found to reflux, but the
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Color duplex scanning after greater saphenous vein sclerotherapy
ipsilateral saphenofemoral junction was competent. Femoral vein reflux was identified in 11 of the 110 limbs (10%), and in every case was associated with both saphenofemoral junction and GSV reflux. No difference was found between those limbs demonstrating GSV obliteration and those not demonstrating GSV obliteration when analyzed for number of injections given or time from completion of injection sclerotherapy. A trend was observed toward more successful results with concentrated injectant- 45% (8/18) having been injected with 3% STD, but this result did not reach statistical significance. Half of the patients (50%) had symptoms related to venous insufficiency, and all but one symptomatic patient demonstrated reflux through both the saphenofemoral junction and the GSV. DISCUSSION
The advantages of treating varicose veins by injection sclerotherapy include no anesthesia, no hospitalization, and no loss of work. For these reasons, injection sclerotherapy has been advocated as an attractive alternative to surgery.7,8However, the results reported here suggest that sclerotherapy of the GSV in the presence of saphenofemoral junction or GSV reflux is unlikely to remain successful in the long term. These data support Hobbs '9 view that the key to successful sclerotherapy is surgical control of greater saphenous vein incompetence. This could be performed with the patient under local anesthesia as advocated by Neglen et al.ll Duplex scanning is an almost ideal method for evaluating the venous system. It is noninvasive and capable of providing both anatomic and functional information. It has become the technique of choice in diagnosing deep venous thrombosis, 2~ and is able to provide quantitative information about the degree of reflux in individual veins. 23 We now believe duplex scanning should be performed before therapy in every patient in whom GSV reflux is suspected or demonstrated with a hand-held Doppler device. When planning treatment for varicose veins, duplex scanning will identify reflux through the saphenofemoral junction. If reflux is found, then surgical ligation of the junction should be undertaken-because the success rate of primary GSV injection sclerotherapy in this series was only 6% in the presence of junction reflux. A 50% success rate was observed if the GSV was competent, and it may be that the injection treatment rendered competent an originally refluxing GSV. Munn et al.2+ have demonstrated a 60% recur-
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rence if the GSV is not stripped, but this report has not been supported in another study comparing saphenofemoral junction ligation with and without stripping of the GSV. 25 Therefore it would seem reasonable to treat a refluxing GSV with injection sclerotherapy if the saphenofemoral junction has been ligated or is naturally competent. Our success rate of 9% in a refluxing GSV reflects the fact that most of these clinical problems are associated with a refluxing saphenofemoral junction. A further source of error may be a bifid GSV with injection sclerotherapy successfully obliterating one branch and leaving the other branch capable of becoming incompetent. Finally, we found a competent saphenofemoral junction in 18 limbs where GSV incompetence was due to a medial thigh perforator. The findings are similar to those of Gooley and Sumner, 2° who also documented thigh perforator valve incompetence as the source of GSV reflux. Such disease can be identified with real-time duplex color scanning as a pretreatment routine evaluation. In conclusion, duplex scanning would appear to be suitable in identifying the venous anatomy and the sites of reflux in patients with varicose veins, thereby allowing a more rational approach to treatment. It would seem that surgical ligation of an incompetent saphenofemoral junction followed by injection sclerotherapy of distal veins would appear to confer the greatest chance of long-term success, with the dual advantages of preserving a portion of the GSV for future use as an arterial conduit, and less morbidity than is associated with GSV stripping. 11'25 In addition, ligation alone has controlled symptoms and resulted in markedly reduced varices in some patients. 9 REFERENCES 1. Avicenna De Ulceribus. Liv IV 10th Cent. 1990. 2. Pare A. The works of that famous chirurgian: Ambrose Pare. London: Cotes and Du Gard, 1579. 3. Dodd H, Cockett FB. The pathology and surgery of the veins of the lower limb. Edinburgh and London: Livingstone, 1956. 4. Browse NL, Burnand K, Thomas M. Diseases of the veins: pathology, diagnosis and treatment. London: Edward Arnold, 1988. 5. Myers TI". Results and technique of stripping operation for varicose veins. JAMA 1957;163:87-92. 6. Rivlin S. The surgical cure of primary varicose veins. Br J Surg 1975;62:913-7. 7. Fegan G. Varicose veins: compression sclerotherapy. London: Heinemann Medical, 1967. 8. Sigg K. Beinleiden. Entstehung und Behandlung. Berlin, Heidelburg, New York: Springer-Verlag, 1967. 9. Hobbs JT. Surgery and sclerotherapy in the treatment of varicose veins. Arch Surg 1974;109:793-6.
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10. Jakobsen BH. The value of different forms of treatment for varicose veins. Br J Surg 1979;66:182-4. 11. Neglen P, Einarsson E, Eklof B. High tie with sclerotherapy for saphenous vein insufficiency. Phebology 1986;1:105-11. I2. Trendelenburg F. Ueber die Unterbindung der Vena Saphena Magna bei Unterschenkelvaricen (Ligation of the greater saphenous vein in varicose veins of the leg). Beitrage zur klinishcen Chirurgie 1890;7:195. 13. Nabatoff RA. Simple palpation to detect valvular incompetence in patients with varicose veins. JAlVlA1955;159:27-8. 14. O'Donnell T, Burnand K, Clemenson G, Thomas ML, Browse NL. Doppler examination vs clinical and phlebographic detection of the localization of incompetent perforating veins. Arch Surg 1977;112:31-5. 15. Ackroyd JS, Thomas ML, Browse NL. Deep vein reflux: an assessment by descending phlebography. Br J Surg 1986;73: 31-3. 16. Bettman MA, Paulin S. Leg phlebography: the incidence, nature and modification of undesirable side effects. Radiology 1977;122:101-4. 17. Sullivan ED, Peter DJ, Cranley JJ. Real time B-mode venous ultrasound. J VAsc SURG 1984;1:465-71. i8. Szendro G, Nicolaides AN, Zukowski AJ, et al. Duplex scanning in the assessment of deep venous incompetence. J VASCSURG 1986;4:237-42.
19. Van Bemmelen PS, Bedford G, Beach K, Strandness DE. Quantitative segmental evaluation of venous valvular reflux with duplex ultrasound scanning. J Vase SFV,G 1989; 10:42531. 20. Gooley NA, Sumner DS. Relationship of venous reflux to the site of venous valvular incompetence: implications for venous reconstructive surgery. J VAsc SURG 1988;7:50-9. 21. Bjordal R. Circulation patterns in incompetent perforating veins in the calf and in the saphenous system in primary varicose veins. Acta Chir Scand 1972;138:257-61. 22. Kmpski WC, Bass A, Dilley RB, Bernstein EF, Otis MS. Propagation of deep venous thrombosis identified by duplex ultrasonography. J VAsc SUV,G 1990;12:467-75. 23. Vasdekis SN, Clarke GH, Nicolaides AN. Quantification of venous reflux by means of duplex scanning. J VASe SURG 1989;10:670-7. 24. Munn SR, Morton JB, Macbeth WAA, McLeish AR. To strip or not to strip the long saphenous vein? A varicose veins trial. Br J Surg i981;68:426-8. 25. Hammarsten J, Pedersen P, Cederlund GG, Campanello M. Long saphenous vein saving surgery for varicose veins. A long-term follow-up. Eur J Vasc Surg 1990;4:361-4.
Submitted Feb. 7, 1991; accepted Apr. 29, 1991.
DISCUSSION Dr. E d m u n d J. H a r r i s (San Mateo, Calif.). This paper represents how conscientious clinical surgeons scientifically determine their results when practicing a popular therapy. The purpose o f this study was to evaluate the efficacy of injection sderotherapy in obliterating the incompetent GSV, thereby controlling the abnormal retrograde or reflux flow producing the venous insufficiency. Of the several new techniques for analyzing venous dysfunction, you selected duplex scanning to measure reflux in anatomically identified veins as well as obliteration or patency. Before discussing the results, I made the assumption that the Sigg method, referring to replacement of the needles for injection with the patient standing and injecting the legs with the patient lying with legs elevated, included compressive bandages for individualized lengths of time. Your 6% success rate in obliterating the GSV with saphenous femoral reflux and your 9% success rate with GSV reflux is lower than I expected. It is my experience that 3% STD is much more effective than less concentrated solutions when treating large veins, and if this solution had been used in all cases, your percentages may have improved slightly. It is my impression that firm elastic support up to the groin for 3 t o 6 weeks is helpful in all but the very obese patients who should opt for surgery. However, your results are not dissimilar to those controlled randomized studies by Hobbs, Jakobsen, and Neglen. I believe the message is that with mainstem incompetence, sclerotherapy results in reoccurrence and should be avoided.
Your GSV obliteration below a competent saphenofemoral junction was 40% and below a normal nonrefluxing greater saphenous vein was 50%. This subset o f patients with varicosities may represent either cases of isolated varices caused by vein wall weakness, a genetic but unidentified defect described by Dr. Sidney Rose, or beginning communication with an incompetent perforator, and both are responsive to sclerotherapy. In contrast to this group, in all the 18 limbs in which the saphenofemoral junction was incompetent, the GS'ff was found to reflux. Dr. Bishop identified these representative examples of localized valve damage and regional reflux, a new concept presented by Gooley and Sumner. Ligation of the source of deep to superficial reflux is the best treatment. I will not comment on the 12% group with femoral vein reflux associated with saphenofemoral junction and GSV reflux since I am unsure whether the common femoral valve is insufficient or the superficial and/or deep femoral are insufficient. Suffice to say these cases are common to our venous practice and must be evaluated for distal deep valvallar insufficiency before treating the varicose veins. Quantification of venous reflux by duplex scanning should be done as well as evaluation of deep vahallar insufficiency by the pneumatic cuff since it will require 25 to 30 cm/sec reverse flow velocity to ensure valve closure. I would like to make a comment and then ask four questions. Ambulatory sclerotherapy is clearly cheaper than
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Color duplex scanning after greater saphenous vein sclerotherapy 509
radical phlebectomy including hospital costs. Government efforts to find the least expensive treatment often overlook the long-term results. I have preferred surgery exclusively to control points of reflux in my patients with stripping, and because of my experience with Warren and Linton using STD, I have continuously used sclerotherapy for the tributaries, small recurrences, and lateral leg incompetent perforators. I have tried to preserve the mainstem vein if it is not severely diseased. This was my technique for combined therapy. Einarsson and Jakobsen both isolated a combined therapy group of patients in whom simple ligation of the saphenofemoral bulb and its branches was combined with distal sclerotherapy. Both found the groups treated with this combined therapy had a fall of cure rate greater than the radical phlebectomy groups, but less than the sclerotherapy groups. With your example, members of this society interested in venous disease ideally will organize patients requiring treatment for venous dysfunction into groups to undergo comparative therapies with pretreatment and posttreatment objective measurement of reflux, so the best and most efficient method be scientifically determined. Have you performed any blood fibrinolytic activity studies in any series of your sclerotherapy patients, and if so, can you identify unlikely candidates? Have you performed any serial studies with duplex scanning on your sclerotherapy patients to appreciate how soon obliteration occurs, and does compressive bandaging minimize intraluminal clot formation? Have you evaluated quantification of venous reflux by duplex scanning on your postsurgical patients? And last, have you any suggestions to facilitate identification of the paired veins of the lower leg and incompetent perforators by color-flow duplex scanning? Dr. Christopher C. R. Bishop, In answer to your first question, we have not performed any fibrinolyfic activity studies on these patients. In some ways I think the main purpose of this study was to relate success to reflux, and I know of no evidence that differing blood fibrinolysis in patients is reflected in differing success rates with injection sclerotherapy. We have not done that. The point about performing serial duplex studies after injection sclerotherapy is a very nice one. One of the problems is that these legs are bandaged up, and if one wanted to get the exact time scale, one would presumably have to scan them over the subsequent hours after injection sclerotherapy because I believe that the therapy works pretty quickly. And these patients are outpatients and, therefore, not available in the hospital to do that. I think it is a nice idea, and we can get more information about how injection sclerotherapy works precisely by doing that study, and I would agree with you that compressive bandaging is essential to prevent thrombosis in the veins. Quantification: Part of the work I d i d involved quantifying reflux both down the femoral vein and clown the GSV, and one can get some quite interesting results.
Unfortunately, the reslilts are very variable, and I could not relate a particular flow velocity or flow volume to success or no success of the technique. What I would like to do is to measure the velocity down the GSV before the injection sclerotherapy and then see whether there was a cutoff below which the treatment would work. And then finally, the point about paired veins and perforators, I think that is a very good point because it may explain some of the failures. A bifid GSV may explain why the injection sclerotherapy failed. One branch may have been successfully obliterated leaving the other branch open and available to be scanned by me 2 years later. Dr. Anthony J. R o o n (Everett, Wash.). I find this a very interesting study, and for someone who does sclerotherapy, I have had problems with success rate in alleviating or thrombosing the veins that were quite large, especially in the saphenons system. In reviewing the techniques for this type of procedure, I find a great number of authors recommended it be done with the patient in the supine position, and I changed that practice to inject veins with the patient upright. Now, although that increases the amount of superficial phlebitis and discomfort, it has increased the number of veins that have been obliterated. I wonder if you have any experience with injecting veins with patients upright, and whether that might improve your results-as our results have shown approximately an 80% success rate eliminating these veins and yours have been in the 40% to 50% range. Dr. Bishop. These patients were all injected by Sigg's method, which is to introduce the needles into the veins with the patient standing and then to inject with the patient supine. So I cannot answer that point specifically. They were all done with the patient supine. Nevertheless, a number of patients were found to have clot in their veins on return visits despite compressive bandaging, but these were dealt with very simply by just incising the vein and squeezing the clot out. Dr. Robert B. Rutherford (Denver, Colo.). Dr. Bishop and his coauthors should be congratulated on a very timely contribution at a time when the dispute between surgery versus sclerotherapy seems to be reaching the national media. I am sure many contributions will be made in the future to try to settle this debate. Another advantage exists to not using sclerotherapy and using simple high ligation, which is a very well-tolerated outpatient procedure, and that is preservation of the saphenous in certain cases.
I recall we selectively used high ligation and sclerotherapy of distal tributary varicosities in what I call stage 1 varicose veins. We have isolated saphenofemoral incompetence in only a few branch varicosities beginning, and it works very well in that situation. If we can show that the GSV by duplex scanning is only mildly dilated, we just do a high ligation in those cases. Last year we reported 10 cases where we restudied the patients and found that in 70% the entire length of saphenous vein was still preserved, and in the other 30%
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the length loss was between 8 and 12 cm. So I think we are also preserving a normal saphenous vein for later use in these early cases. Dr. Bishop. I think that is a very good point. I do not want to sacrifice a GSV that is potentially usable at some future date. Of course the problem with the very dilated veins is they may not be usable in the future. I initially stripped all GSVs to the knee because I believe Morton and Munn's figures that if you did not do that you got a 60% recurrence rate. Those figures have now been refuted by Hammersten who says that you can preserve the GSV if you are selective about it, and I would support you in that view. Dr. Eugene F. Bernstein. I think it is important that in thinking about this material you understand that the physicians doing the scterotherapy were Drs. Arnost and Helene Fronek who were trained by Sigg. Arnost Fronek has practiced sclerotherapy for approximately 20 years, with at least 4000 cases of his own personal experience, and
as many of you know, he is also an expert Doppler user. He had identified these patients with a hand-held Doppler and tried to duplicate what had been reported by European sclerotherapists in directly obliterating a GSV with considerable reflux. As a result of this review, we have abandoned the Sigg approach. Second, we use the Quantum real-time color scanner in every case now when the hand-held Doppler suggests reflux-to tell us exactly where the incompetent valve is. I say this to emphasize that 18 of these patients had reflux not from the saphenofemoral junction, but from a collateral vessel that you can pinpoint with a Quantum scanner. You just make a little "x" on the skin then tie off that little collateral vessel, and you have solved the problem. Our current approach is to divide the incompetent saphenofemoral junction, or other incompetent valve with the patient under local anesthesia. A month later, w~ perform sclerotherapy for any remaining varices.
S O C I E T Y F O R VASCULAR SURGERY LIFELINE FOUNDATION GRANT AWARD The Lifeline Foundation of the Society for Vascular Surgery invites grant applications for funding of meritorious research by young surgical investigators. The awards are intended for surgeons who have completed their formal surgical education in general surgery and who have completed or are in an advanced training program in vascular surgery. To be considered for selection a candidate: 1. Should be certified by the American Board of Surgery or have completed the requirements for ce~xification 2. Should submit an application within three years of completion of an approved residency training program 3. Must have either a faculty appointment in an approved medical school in the United States or Canada or have received an academic appointment within the guidelines of the applicant's institution Grant awards are not intended to supplement salary, which will remain the responsibility of the institution in which the awardee holds an appointment. The awardee is expected to devote a significant amount of time to the funded project. A progress report will be presented by the investigators during the annual meeting of the Society for Vascular Surgery. A grant awards committee will review competitive applications. It is anticipated that two grants will be awarded annually totaling $50,000 each to include indirect costs. Each award will be for one year with the option to extend for an additional year. Grant applications may be obtained from: The Lifeline Foundation Society for Vascular Surgery Thirteen Elm St. Manchester, MA 01944 The deadline for receiving applications in the Foundation office is January 15, 1992. Funds will be awarded by July 1, 1992.
La folla, Calif. A color real-time duplex scanner was used to scan the greater saphenous vein in 89 limbs of 55 patients to study the efficacy of prior greater saphenous vein sclerotherapy. The greater saphenous vein was insonated from the saphenofemoral junction to the knee to evaluate both reflux to a standardized 30 mm Hg Valsalva maneuver and evidence of greater saphenous vein obliteration by sclerotherapy. These data were correlated with the number ofsderosing injections used (mean, 1.8; range, 1 to 6), time from the last injection (mean, 27.5 mo.; range, 3 to 55 mo), and concentration of injectant used (0.5% to 3% sodium tetradecyl sulfate). Fifty-one of 89 injected limbs (57%) demonstrated reflux through the saphenofemoral junction, and reflux down the more distal greater saphenous vein was found in 67 of 89 injected limbs (75%). Greater saphenous vein obliteration was noted in only 18 of 89 injected limbs (20%); two were totally obliterated, and 16 were partially obliterated. The greater saphenous vein was obliterated in 6% below a refluxing saphenofemoral junction and in 40% below a nonrefluxing junction. A greater saphenous vein obliteration rate of 9% was found with a refluxing greater saphenous vein, and 50% in a nonrefluxing greater saphenous vein. Femoral vein reflux was identified in 11 of the 110 limbs (10%) and in every case was associated with both saphenofemoral junction and greater saphenous vein reflux. We noted a trend toward more successful results with more concentrated injectate (3% sodium tetradecyl sulfate). Fifty percent of patients reported improvement in symptoms. We conclude that sclerotherapy of the greater saphenous vein in the presence of saphenofemoral junction or greater saphenous vein reflux is unlikely to remain successful in the long term. These patients require control of the refluxing junction before sclerotherapy. (J Vase SURG 1991;14:505-10.)
Varicose veins are a common problem in humans and are a reflection of the uptight human posture. Fortunately, our understanding of venous pathophysiology has improved since the days when varices were believed to contain "black bile, "~ and varicose veins were attributed to a high melancholy temper in men. 2 Despite our increased knowledge of the origin of varicose veins, the optimum treatment remains controversial. The principle behind successful therapy includes the correct identification of the site of valvular incompetence and the subsequent control of this site by either surgery or injection sclerotherapy. 3-s From the Division of Vascular and Thoracic Surgery, Scripps Clinic and ResearchFoundation, La Jolla. Supported by the Vascular Disease Foundation, La Jolla, Calif. Presented at the Sixth AnnualMeeting of the Western Vascular Society, Palm Springs, Calif.,Jan. 13-16, 1991. Reprint requests: EugeneF. Bernstein,MD, Divisionof Vascular and ThoracicSurgery,ScrippsClinicand ResearchFoundation, 10666 N. Torrey Pines Rd., La Jolla, CA 92037. 24/6/30558
Two randomized studies that compared injection sclerotherap!¢ to surgery concluded that injection sclerotherapy was inferior in the presence of greater saphenous vein (GSV) incompetence. 9"1°Recurrence of varicose veins was related to inadequate control of the saphenofemoral junction, whether treated by surgery or injection sclerotherapy, but the failure rate was greater after injection sclerotherapy alone. An alternative approach for saphenous vein incompetence is ligation of the saphenofemoral junction followed by injection of the varices and the GSV. n Nevertheless, the development of better and more concentrated safe sclerosing agents stimulated us to attempt sclerotherapy alone for a group of patients with varices and GSV incompetence identified by hand-held Doppler examination. This report evaluates the results of this more recent approach. The presence of retrograde flow in veins was first recognized by Trendelenburg, 12 and the Brodie and Trendelenburg test remains the traditional clinical test for GSV reflux. Nabatoff 13 has claimed that 505
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simple inspection and palpation is sufficiently accurate in the detection of sites of valvular incompetence, and O'Donnell et al.,14 in a study comparing Doppler with clinical and phlebographic detection of incompetent perforating veins, showed that only phlebography demonstrated a significant improvement over clinical examination, but this predated the availability of duplex and real-time color imaging ultrasound systems. Descending venography will identify reflux through the saphenofemoral junction and down the GSV, 1~ but it is associated with the morbidity of the procedure26 Therefore an alternative nonlnvasive method of assessing GSV reflux would be welcome. The duplex scanner has been used to evaluate the venous system) 7 It can readily identify reflux in specific veins and can ,be used in conjunction with a Valsalva maneuver?8:~9 Furthermore, t h e duplex scanner has demonstrated a competent saphenofemoral junction in the presence of clinically obvious varicose veins, 2° and the existence of short segments of reflux within an otherwise normal venous system. 18 If Bjordalz~ is correct in suggesting that the main cause of raised venous pressure is the reflux of blood down the GSV, then identification of the precise site of valvular incompetence in patients with varicose veins would enable the selection of the most appropriate method of treatment. This study reports the use of real-time color duplex scanning after injection sclerotherapy of the GSV, to evaluate the efficacy of this therapy. PATIENTS A N D M E T H O D S Fifty-five patients (39 women, 16 men) of mean age 41 years (range, 19 to 67), who had previously undergone injection sclerotherapy of the GSV for symptomatic varicosities, were studied. Thirty-four patients had both GSVs injected, providing 89 limbs for evaluation by duplex scanning. Injection sclerotherapy was performed by the method of Sigg, s using between two and four injections of 0.5 ml Sotradecol (STD) into the GSV. In this method the needle is inserted with the patient in the upright position, and injections are begun in the most distal varicose vein, proceeding proximally. Once the needle is in the varicosity, the patient is then placed in the supine position with the leg elevated to empty the vein. Postinjection compression of the injected site is then maintained for 3 weeks with elastic wraps. Injectant was introduced at 5 cm intervals along the entire course of the GSV from ankle to upper thigh, with special attention to the additional injection of the site of all perforating veins, including the midthigh
lournal of VASCULAR SURGERY
perforation, when present. The concentration of STD ranged from 0.5% to 3%, with most injections of either 1% (45/89) or 3% (23/89). The number of sessions at which the GSV was injected ranged from one to six, with a mean of 1.8. The time from completion of the sclerotherapy treatment to duplex scanning ranged from 3 to 55 months, with a mean of 27.5 months. Duplex scanning was performed with the Quantum QAD-1 Color Duplex Scanner (Quantum Medical Systems, Issaquah, Wash.). A 7.5 MHz probe was used to insonate the GSV from the saphenofemoral junction down to the knee. Reflux was assessed by having the patient perform a standardized Valsalva maneuver by blowing into a mouthpiece connected to a sphygmomanometer and maintaining a pressure. of 30 mm Hg for 5 seconds. Reflux was considered present if reverse flow was seen in the GSV or through the saphenofemoral junction during the whole period of the Valsalva maneuver: Occasionally, reverse flow was present for a second or so before the valves closing, and these instances were reported as competent veins. Evidence o f total or partial obliteration of the GSV was evaluated, as this had been the purpose of the original injection sclerotherapy treatment. RESULTS Fifty-one of 89 injected limbs (57%) demonstrated reflux through the saphenofemoral junction, and reflux down the more distal GSV was found in 67 of 89 injected limbs (75%). Greater saphenous vein obliteration was noted in only 18 of 89 injected limbs (20%); two were totally obliterated, and 16 were partially obliterated along some portion of the length of the GSV. Both the GSVs that were totally, obliterated were below a competent saphenofemoral junction, and 13 of 16 partially obliterated GSVs were below a competent GSV. Therefore relating GSV obliteration to the status of the ipsilateral saphenofemoral junction resulted in a GSV obliteration rate of 40% (15/38) if the saphenofemoral junction was competent and a GSV obliteration rate of 6% (3/51) if the saphenofemoral junction demonstrated reflux. In the 16 GSVs that were partially obliterated, the remaining "open" portion of the GSV was normal in 10 and refluxed in six. Ten partially obliterated GSVs were associated with a normal (nonrefluxing) GSV, giving an obliteration rate of 50% (10/20), whereas if the GSV refluxed, the obliteration rate was only 9% (6/67). In 18 limbs the GSV was found to reflux, but the
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Color duplex scanning after greater saphenous vein sclerotherapy
ipsilateral saphenofemoral junction was competent. Femoral vein reflux was identified in 11 of the 110 limbs (10%), and in every case was associated with both saphenofemoral junction and GSV reflux. No difference was found between those limbs demonstrating GSV obliteration and those not demonstrating GSV obliteration when analyzed for number of injections given or time from completion of injection sclerotherapy. A trend was observed toward more successful results with concentrated injectant- 45% (8/18) having been injected with 3% STD, but this result did not reach statistical significance. Half of the patients (50%) had symptoms related to venous insufficiency, and all but one symptomatic patient demonstrated reflux through both the saphenofemoral junction and the GSV. DISCUSSION
The advantages of treating varicose veins by injection sclerotherapy include no anesthesia, no hospitalization, and no loss of work. For these reasons, injection sclerotherapy has been advocated as an attractive alternative to surgery.7,8However, the results reported here suggest that sclerotherapy of the GSV in the presence of saphenofemoral junction or GSV reflux is unlikely to remain successful in the long term. These data support Hobbs '9 view that the key to successful sclerotherapy is surgical control of greater saphenous vein incompetence. This could be performed with the patient under local anesthesia as advocated by Neglen et al.ll Duplex scanning is an almost ideal method for evaluating the venous system. It is noninvasive and capable of providing both anatomic and functional information. It has become the technique of choice in diagnosing deep venous thrombosis, 2~ and is able to provide quantitative information about the degree of reflux in individual veins. 23 We now believe duplex scanning should be performed before therapy in every patient in whom GSV reflux is suspected or demonstrated with a hand-held Doppler device. When planning treatment for varicose veins, duplex scanning will identify reflux through the saphenofemoral junction. If reflux is found, then surgical ligation of the junction should be undertaken-because the success rate of primary GSV injection sclerotherapy in this series was only 6% in the presence of junction reflux. A 50% success rate was observed if the GSV was competent, and it may be that the injection treatment rendered competent an originally refluxing GSV. Munn et al.2+ have demonstrated a 60% recur-
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rence if the GSV is not stripped, but this report has not been supported in another study comparing saphenofemoral junction ligation with and without stripping of the GSV. 25 Therefore it would seem reasonable to treat a refluxing GSV with injection sclerotherapy if the saphenofemoral junction has been ligated or is naturally competent. Our success rate of 9% in a refluxing GSV reflects the fact that most of these clinical problems are associated with a refluxing saphenofemoral junction. A further source of error may be a bifid GSV with injection sclerotherapy successfully obliterating one branch and leaving the other branch capable of becoming incompetent. Finally, we found a competent saphenofemoral junction in 18 limbs where GSV incompetence was due to a medial thigh perforator. The findings are similar to those of Gooley and Sumner, 2° who also documented thigh perforator valve incompetence as the source of GSV reflux. Such disease can be identified with real-time duplex color scanning as a pretreatment routine evaluation. In conclusion, duplex scanning would appear to be suitable in identifying the venous anatomy and the sites of reflux in patients with varicose veins, thereby allowing a more rational approach to treatment. It would seem that surgical ligation of an incompetent saphenofemoral junction followed by injection sclerotherapy of distal veins would appear to confer the greatest chance of long-term success, with the dual advantages of preserving a portion of the GSV for future use as an arterial conduit, and less morbidity than is associated with GSV stripping. 11'25 In addition, ligation alone has controlled symptoms and resulted in markedly reduced varices in some patients. 9 REFERENCES 1. Avicenna De Ulceribus. Liv IV 10th Cent. 1990. 2. Pare A. The works of that famous chirurgian: Ambrose Pare. London: Cotes and Du Gard, 1579. 3. Dodd H, Cockett FB. The pathology and surgery of the veins of the lower limb. Edinburgh and London: Livingstone, 1956. 4. Browse NL, Burnand K, Thomas M. Diseases of the veins: pathology, diagnosis and treatment. London: Edward Arnold, 1988. 5. Myers TI". Results and technique of stripping operation for varicose veins. JAMA 1957;163:87-92. 6. Rivlin S. The surgical cure of primary varicose veins. Br J Surg 1975;62:913-7. 7. Fegan G. Varicose veins: compression sclerotherapy. London: Heinemann Medical, 1967. 8. Sigg K. Beinleiden. Entstehung und Behandlung. Berlin, Heidelburg, New York: Springer-Verlag, 1967. 9. Hobbs JT. Surgery and sclerotherapy in the treatment of varicose veins. Arch Surg 1974;109:793-6.
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10. Jakobsen BH. The value of different forms of treatment for varicose veins. Br J Surg 1979;66:182-4. 11. Neglen P, Einarsson E, Eklof B. High tie with sclerotherapy for saphenous vein insufficiency. Phebology 1986;1:105-11. I2. Trendelenburg F. Ueber die Unterbindung der Vena Saphena Magna bei Unterschenkelvaricen (Ligation of the greater saphenous vein in varicose veins of the leg). Beitrage zur klinishcen Chirurgie 1890;7:195. 13. Nabatoff RA. Simple palpation to detect valvular incompetence in patients with varicose veins. JAlVlA1955;159:27-8. 14. O'Donnell T, Burnand K, Clemenson G, Thomas ML, Browse NL. Doppler examination vs clinical and phlebographic detection of the localization of incompetent perforating veins. Arch Surg 1977;112:31-5. 15. Ackroyd JS, Thomas ML, Browse NL. Deep vein reflux: an assessment by descending phlebography. Br J Surg 1986;73: 31-3. 16. Bettman MA, Paulin S. Leg phlebography: the incidence, nature and modification of undesirable side effects. Radiology 1977;122:101-4. 17. Sullivan ED, Peter DJ, Cranley JJ. Real time B-mode venous ultrasound. J VAsc SURG 1984;1:465-71. i8. Szendro G, Nicolaides AN, Zukowski AJ, et al. Duplex scanning in the assessment of deep venous incompetence. J VASCSURG 1986;4:237-42.
19. Van Bemmelen PS, Bedford G, Beach K, Strandness DE. Quantitative segmental evaluation of venous valvular reflux with duplex ultrasound scanning. J Vase SFV,G 1989; 10:42531. 20. Gooley NA, Sumner DS. Relationship of venous reflux to the site of venous valvular incompetence: implications for venous reconstructive surgery. J VAsc SURG 1988;7:50-9. 21. Bjordal R. Circulation patterns in incompetent perforating veins in the calf and in the saphenous system in primary varicose veins. Acta Chir Scand 1972;138:257-61. 22. Kmpski WC, Bass A, Dilley RB, Bernstein EF, Otis MS. Propagation of deep venous thrombosis identified by duplex ultrasonography. J VAsc SUV,G 1990;12:467-75. 23. Vasdekis SN, Clarke GH, Nicolaides AN. Quantification of venous reflux by means of duplex scanning. J VASe SURG 1989;10:670-7. 24. Munn SR, Morton JB, Macbeth WAA, McLeish AR. To strip or not to strip the long saphenous vein? A varicose veins trial. Br J Surg i981;68:426-8. 25. Hammarsten J, Pedersen P, Cederlund GG, Campanello M. Long saphenous vein saving surgery for varicose veins. A long-term follow-up. Eur J Vasc Surg 1990;4:361-4.
Submitted Feb. 7, 1991; accepted Apr. 29, 1991.
DISCUSSION Dr. E d m u n d J. H a r r i s (San Mateo, Calif.). This paper represents how conscientious clinical surgeons scientifically determine their results when practicing a popular therapy. The purpose o f this study was to evaluate the efficacy of injection sderotherapy in obliterating the incompetent GSV, thereby controlling the abnormal retrograde or reflux flow producing the venous insufficiency. Of the several new techniques for analyzing venous dysfunction, you selected duplex scanning to measure reflux in anatomically identified veins as well as obliteration or patency. Before discussing the results, I made the assumption that the Sigg method, referring to replacement of the needles for injection with the patient standing and injecting the legs with the patient lying with legs elevated, included compressive bandages for individualized lengths of time. Your 6% success rate in obliterating the GSV with saphenous femoral reflux and your 9% success rate with GSV reflux is lower than I expected. It is my experience that 3% STD is much more effective than less concentrated solutions when treating large veins, and if this solution had been used in all cases, your percentages may have improved slightly. It is my impression that firm elastic support up to the groin for 3 t o 6 weeks is helpful in all but the very obese patients who should opt for surgery. However, your results are not dissimilar to those controlled randomized studies by Hobbs, Jakobsen, and Neglen. I believe the message is that with mainstem incompetence, sclerotherapy results in reoccurrence and should be avoided.
Your GSV obliteration below a competent saphenofemoral junction was 40% and below a normal nonrefluxing greater saphenous vein was 50%. This subset o f patients with varicosities may represent either cases of isolated varices caused by vein wall weakness, a genetic but unidentified defect described by Dr. Sidney Rose, or beginning communication with an incompetent perforator, and both are responsive to sclerotherapy. In contrast to this group, in all the 18 limbs in which the saphenofemoral junction was incompetent, the GS'ff was found to reflux. Dr. Bishop identified these representative examples of localized valve damage and regional reflux, a new concept presented by Gooley and Sumner. Ligation of the source of deep to superficial reflux is the best treatment. I will not comment on the 12% group with femoral vein reflux associated with saphenofemoral junction and GSV reflux since I am unsure whether the common femoral valve is insufficient or the superficial and/or deep femoral are insufficient. Suffice to say these cases are common to our venous practice and must be evaluated for distal deep valvallar insufficiency before treating the varicose veins. Quantification of venous reflux by duplex scanning should be done as well as evaluation of deep vahallar insufficiency by the pneumatic cuff since it will require 25 to 30 cm/sec reverse flow velocity to ensure valve closure. I would like to make a comment and then ask four questions. Ambulatory sclerotherapy is clearly cheaper than
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Color duplex scanning after greater saphenous vein sclerotherapy 509
radical phlebectomy including hospital costs. Government efforts to find the least expensive treatment often overlook the long-term results. I have preferred surgery exclusively to control points of reflux in my patients with stripping, and because of my experience with Warren and Linton using STD, I have continuously used sclerotherapy for the tributaries, small recurrences, and lateral leg incompetent perforators. I have tried to preserve the mainstem vein if it is not severely diseased. This was my technique for combined therapy. Einarsson and Jakobsen both isolated a combined therapy group of patients in whom simple ligation of the saphenofemoral bulb and its branches was combined with distal sclerotherapy. Both found the groups treated with this combined therapy had a fall of cure rate greater than the radical phlebectomy groups, but less than the sclerotherapy groups. With your example, members of this society interested in venous disease ideally will organize patients requiring treatment for venous dysfunction into groups to undergo comparative therapies with pretreatment and posttreatment objective measurement of reflux, so the best and most efficient method be scientifically determined. Have you performed any blood fibrinolytic activity studies in any series of your sclerotherapy patients, and if so, can you identify unlikely candidates? Have you performed any serial studies with duplex scanning on your sclerotherapy patients to appreciate how soon obliteration occurs, and does compressive bandaging minimize intraluminal clot formation? Have you evaluated quantification of venous reflux by duplex scanning on your postsurgical patients? And last, have you any suggestions to facilitate identification of the paired veins of the lower leg and incompetent perforators by color-flow duplex scanning? Dr. Christopher C. R. Bishop, In answer to your first question, we have not performed any fibrinolyfic activity studies on these patients. In some ways I think the main purpose of this study was to relate success to reflux, and I know of no evidence that differing blood fibrinolysis in patients is reflected in differing success rates with injection sclerotherapy. We have not done that. The point about performing serial duplex studies after injection sclerotherapy is a very nice one. One of the problems is that these legs are bandaged up, and if one wanted to get the exact time scale, one would presumably have to scan them over the subsequent hours after injection sclerotherapy because I believe that the therapy works pretty quickly. And these patients are outpatients and, therefore, not available in the hospital to do that. I think it is a nice idea, and we can get more information about how injection sclerotherapy works precisely by doing that study, and I would agree with you that compressive bandaging is essential to prevent thrombosis in the veins. Quantification: Part of the work I d i d involved quantifying reflux both down the femoral vein and clown the GSV, and one can get some quite interesting results.
Unfortunately, the reslilts are very variable, and I could not relate a particular flow velocity or flow volume to success or no success of the technique. What I would like to do is to measure the velocity down the GSV before the injection sclerotherapy and then see whether there was a cutoff below which the treatment would work. And then finally, the point about paired veins and perforators, I think that is a very good point because it may explain some of the failures. A bifid GSV may explain why the injection sclerotherapy failed. One branch may have been successfully obliterated leaving the other branch open and available to be scanned by me 2 years later. Dr. Anthony J. R o o n (Everett, Wash.). I find this a very interesting study, and for someone who does sclerotherapy, I have had problems with success rate in alleviating or thrombosing the veins that were quite large, especially in the saphenons system. In reviewing the techniques for this type of procedure, I find a great number of authors recommended it be done with the patient in the supine position, and I changed that practice to inject veins with the patient upright. Now, although that increases the amount of superficial phlebitis and discomfort, it has increased the number of veins that have been obliterated. I wonder if you have any experience with injecting veins with patients upright, and whether that might improve your results-as our results have shown approximately an 80% success rate eliminating these veins and yours have been in the 40% to 50% range. Dr. Bishop. These patients were all injected by Sigg's method, which is to introduce the needles into the veins with the patient standing and then to inject with the patient supine. So I cannot answer that point specifically. They were all done with the patient supine. Nevertheless, a number of patients were found to have clot in their veins on return visits despite compressive bandaging, but these were dealt with very simply by just incising the vein and squeezing the clot out. Dr. Robert B. Rutherford (Denver, Colo.). Dr. Bishop and his coauthors should be congratulated on a very timely contribution at a time when the dispute between surgery versus sclerotherapy seems to be reaching the national media. I am sure many contributions will be made in the future to try to settle this debate. Another advantage exists to not using sclerotherapy and using simple high ligation, which is a very well-tolerated outpatient procedure, and that is preservation of the saphenous in certain cases.
I recall we selectively used high ligation and sclerotherapy of distal tributary varicosities in what I call stage 1 varicose veins. We have isolated saphenofemoral incompetence in only a few branch varicosities beginning, and it works very well in that situation. If we can show that the GSV by duplex scanning is only mildly dilated, we just do a high ligation in those cases. Last year we reported 10 cases where we restudied the patients and found that in 70% the entire length of saphenous vein was still preserved, and in the other 30%
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the length loss was between 8 and 12 cm. So I think we are also preserving a normal saphenous vein for later use in these early cases. Dr. Bishop. I think that is a very good point. I do not want to sacrifice a GSV that is potentially usable at some future date. Of course the problem with the very dilated veins is they may not be usable in the future. I initially stripped all GSVs to the knee because I believe Morton and Munn's figures that if you did not do that you got a 60% recurrence rate. Those figures have now been refuted by Hammersten who says that you can preserve the GSV if you are selective about it, and I would support you in that view. Dr. Eugene F. Bernstein. I think it is important that in thinking about this material you understand that the physicians doing the scterotherapy were Drs. Arnost and Helene Fronek who were trained by Sigg. Arnost Fronek has practiced sclerotherapy for approximately 20 years, with at least 4000 cases of his own personal experience, and
as many of you know, he is also an expert Doppler user. He had identified these patients with a hand-held Doppler and tried to duplicate what had been reported by European sclerotherapists in directly obliterating a GSV with considerable reflux. As a result of this review, we have abandoned the Sigg approach. Second, we use the Quantum real-time color scanner in every case now when the hand-held Doppler suggests reflux-to tell us exactly where the incompetent valve is. I say this to emphasize that 18 of these patients had reflux not from the saphenofemoral junction, but from a collateral vessel that you can pinpoint with a Quantum scanner. You just make a little "x" on the skin then tie off that little collateral vessel, and you have solved the problem. Our current approach is to divide the incompetent saphenofemoral junction, or other incompetent valve with the patient under local anesthesia. A month later, w~ perform sclerotherapy for any remaining varices.
S O C I E T Y F O R VASCULAR SURGERY LIFELINE FOUNDATION GRANT AWARD The Lifeline Foundation of the Society for Vascular Surgery invites grant applications for funding of meritorious research by young surgical investigators. The awards are intended for surgeons who have completed their formal surgical education in general surgery and who have completed or are in an advanced training program in vascular surgery. To be considered for selection a candidate: 1. Should be certified by the American Board of Surgery or have completed the requirements for ce~xification 2. Should submit an application within three years of completion of an approved residency training program 3. Must have either a faculty appointment in an approved medical school in the United States or Canada or have received an academic appointment within the guidelines of the applicant's institution Grant awards are not intended to supplement salary, which will remain the responsibility of the institution in which the awardee holds an appointment. The awardee is expected to devote a significant amount of time to the funded project. A progress report will be presented by the investigators during the annual meeting of the Society for Vascular Surgery. A grant awards committee will review competitive applications. It is anticipated that two grants will be awarded annually totaling $50,000 each to include indirect costs. Each award will be for one year with the option to extend for an additional year. Grant applications may be obtained from: The Lifeline Foundation Society for Vascular Surgery Thirteen Elm St. Manchester, MA 01944 The deadline for receiving applications in the Foundation office is January 15, 1992. Funds will be awarded by July 1, 1992.