Way before the era of Doppler and duplex examinations, Tom Meyers from the Mayo clinic ( who introduced the flexible intraluminal stripper) was quoted, on the pages of Pageant of April 1967 as saying that "sclerotherapy (for varicose veins) is a return to the dark ages of medicine". How right he was!
One has to concede, that sclerotherapy sounds like an appealing therapeutic modality as it shifts medical care away from the costly hospital setting required by the conventional surgical stripping . The question honest, ethical and moral practitioners have to ask themselves is: can a treatment, varicose veins included, with an unacceptably high failure rate be offered to patients just on the basis of cost efficiency. This question is especially pertinent at the present time as today one can perform a cost efficient minimally invasive surgery for varicose veins (invaginated stripping and hook stab avulsion of the varicose tributaries) as an office procedure under local anesthesia with excellent long term results.
Personally, I have used the classical Fegan injection protocol with judicious 6 week compression from 1984-86. By the end of the second year, close to 60-80% of patients were back in my office with "recurrent" varicose veins that basically were residual varicose veins. From 1986-1990 in hope for better results I controlled the junctional reflux by its surgical ligation as a concomitant office procedure under local anesthesia. Not even this this approach gave the desired results, as the 4 year failure rates were 40-50%*. These results were in concordance with other publications on the subject published before and after 1991. While I wrote a critical review article on the history and effectiveness of injection sclerotherapy for varicose veins (Phlebology 1991; 6:7-11) I will reproduce a letter I sent in the autumn of 1994 to the editor of the Journal of the American Academy of Dermatology (JAAD) which contains far more details than the 1991 review article. I hope that honest practitioners will find it useful.
*Since 1990 I exclusively use the surgical alternative for varicose veins in its minimally invasive form: high ligation and invaginated stripping (when needed) in conjunction with tributary phlebectomy by phlebextractor hooks. It is performed in an office setting and under loco-regional anesthesia. Up to the present (January 1995) I have performed over 900 surgeries of this kind.
Injection Sclerotherapy for Truncal Varicose Veins: Effectiveness and Phlebological Politics
Sir, I read with interest the detailed review article on diagnosis and treatment of varicose veins that was recently published in your journal by Weiss RA, Goldman MP, Bergan JJ [1] and I would like to commend the authors for taking on a complex and highly charged subject.
Although generously referenced, I feel that recent, additional and important information regarding the unacceptably high failure rate of injection sclerotherapy for primary varicose veins was omitted by the authors. Referencing these works, the subject of this letter, would have given the readers of your prestigious Journal, a better and more accurate understanding of the available therapeutic options for the condition.
The pre-duplex era has seen three major randomized studies comparing the outcome of sclerotherapy versus surgery in the treatment of primary varicose veins.
The first to publish disappointing results of the injection compression method was Hobbs (2) in 1974. While Hobbs' study was fleetingly quoted in the review article, no percentage rates were, however, mentioned. These were, at six year follow up, a disappointing 65% failure rate for compression sclerotherapy versus only 20% for conventional stripping. The next randomized study by Jakobsen(3), published in 1979, was totally omitted by the review article. In this randomized study the reported three year failure rate for sclerotherapy was similarly a disappointing 63% versus only 10% after surgery! Einarsson, Eklof and Neglen (4), who for the first time used clear objective hemodynamic (foot volumetry) criteria in assessing their results, reported in 1993 on the pages of the highly visible journal of Phlebology, a disappointing 74% five year failure rate following injection sclerotherapy, versus only 10 % failure rate for conventional surgery! Similarly, while a different work by Neglen was referenced in the review article, the above given disappointing percentage rates were not made available to the reader.
Moreover, additional studies also pointed towards the inefficacy of even a combined approach: i.e. surgical control (high ligation) of the most proximal escape point in conjunction with compressive sclerotherapy. The same Jakobsen (3) reported in 1979 a three year failure rate of 35% for this combined approach. More recently, Neglen in 1986 (5) came to the same negative conclusion. Our study, in 1991 (6), with an identical protocol to Jakobsen and Neglen, produced similarly an unacceptably high five year recurrence rate of 40-50%. (These last two studies were published also in the highly visible journal of Phlebology.) In a just published randomized study from The Netherlands (7), the three year follow up failure rate of this combined approach for long saphenous varicosities was an unacceptably high 50%!
The real damaging data regarding the injection method came, however, with recent publications, none of them referenced in the review article, that used objective duplex imaging for assessment of the therapeutic outcome of injection sclerotherapy in lieu of the "traditional" visual assessment coupled with finger palpation of the injected veins, a method that invariably produced "excellent" results(8).
In the first study, Bishop, Fronek and Fronek, in 1991 (9), found that injection sclerotherapy control of the proximal escape points, such as the saphenofemoral junction, will fail in 80% of cases in a mean short two year follow up! Gongolo at al. also in 1991 (10), using similar duplex objective criteria, recorded the reestablishment of reflux , and thus a failure of injection compressive sclerotherapy, also in a short 2 year follow up period, in up to 60% of cases!
More recently, Biegeleisen, in 1994(11), using the most advanced technology available (angioscopy) to guide the delivery of sclerosant and to follow up, (in conjunction with duplex imaging), the effect of treatment, shows an invariable 100% (!) failure rate to control the valvular incompetence and axial reflux existing in the long saphenous varicosities. This became evident after only one year follow-up period! Thus, it was demonstrated, for the first time, that sclerotherapy fails even when treatment has been selectively applied to the offending varicosity. This should, and will, have clear implications for the growing enthusiasm which ultrasound - guided sclerotherapy or echosclerotherapy is having among certain sclerotherapists. The likely efficacy of this yet another expensive and extravagant delivery form of injection sclerotherapy is, in the light of this last study, more than doubtful.
In conclusion, injection compression sclerotherapy with a 60-100% failure rate, is not be considered a viable primary therapeutic option for varicose veins, at least not in the hands of a responsible practitioner. There could be no moral or ethical reasoning for promoting and performing a therapeutic method that has such an unacceptably high recurrence rate. Nobody would dare to promote and perform a method of herniorrhaphy that has a 60-100% five year failure rate! I dare repeating, therefore, a previous statement of mine voiced already in 1991(6), namely that injection compression sclerotherapy for primary truncal varicose veins, as an initial treatment option, has to be ditched, dodged, denied, and discarded from our therapeutic arsenal.
Moreover, with close to 80% cases clearly harboring detectable escape points and axial refluxes(12), the only viable therapeutic alternative for primary varicose veins, to be promoted and performed, remains surgery but in its new and tamed form i.e. the invaginated (and limited) axial stripping(13-14) in conjunction with stab avulsion (hook) phlebextraction of the varicose tributaries(15-16). Without compromising hemodynamic principles (17), the method is performed in an office setting and under strictly loco- regional (femoral block) anesthesia (18), thus overriding the last argument indiscriminate vein injectors have, namely cost efficiency. Eliminating hospitalization, general anesthesia and convalescence, this method has all the advantages of injection sclerotherapy, except that the long term results will be incomparably better. Our comprehensive and up to date surgical protocol, based on over 600 operated cases over a 4 year period, will see print in the not too distant future(19).
It is unfortunate, however, that the omission, by the authors of the review article, to reference the above quoted comprehensive information was, in my humble opinion, not by chance but by deliberate (political and economical) choice.
The journal of Phlebology, where some of the deleted information was published (4-6), is a highly visible, only English speaking professional journal read by all serious practitioners of the trade. So is the Journal of Vascular Surgery, which published one of the duplex criteria follow up studies (9). Written with the collaboration of A. Fronek and H. Fronek, both holders of highly visible positions in the North American Society of Phlebology (NASP), the authors of the review article, all possessors of similar positions in the same professional organization, should have been familiar with the damaging data emerging from the Froneks' study. It is conceivable that it was this damaging data that the authors of the review article wanted to withhold (or at least not to highlight) before their readers.
As such, I question the real agenda of the authors of the review article, since one of them (RA Weiss.) engaged not to long time ago in clear public misinformation, on the pages of a national tabloid (Enquirer, June 1993), acclaiming echosclerotherapy as "good news for the 80 million American sufferers of varicose veins and (yes!) spider veins". At the end of this well orchestrated infomercial, the naive reader is advised to call or write the NASP headquarters (phone and address provided) to find a doctor who performs echosclerotherapy, " a painless 15 minute technique..." that... "usually eliminates the varicose veins in one or two treatments".
For me, the lack of referencing important (but potentially) damaging scientific information from highly visible professional journals to a medical readership measures up with the dissemination of misinformation to the lay public. In my opinion these efforts constitute basically the hidden but real agenda of the authors of the review article. They were meant to keep sclerotherapy (or the financially more rewarding echosclerotherapy ) alive and well and as a viable therapeutic alternative for those practitioners - representing the overwhelming majority among NASP members- who are surgically unskilled to perform the delicate, sometimes technically challenging, junctional ligation and axial stripping.
Personally, I believe, however, that it is ethical and moral corruption for a professional organization, that should be preoccupied and concerned with the safety and well being of the consumer, not only to engage in this type of misinformation, but also to shelter and permit its members to promote end perform a therapeutic procedure that has a 60-100% failure rate. Yet, the local (Los Angeles and Orange county's) NASP members who actively advertise echosclerotherapy, over the pages of regular daily newspapers as a viable, even advantageous alternative to surgery, proudly flag their membership in the organization.
Bergan (20), one of the coauthors of the review article, only
few years ago summed up the therapeutic dilemma between the sclerotherapic
and surgical approach for primary varicose veins with an accurate
statement that needs no comment on my part: "It is anticipated that pure sclerotherapy in the treatment of
varicosities to the exclusion of other modalities will not gain
acceptance in institutions where critical review of results is
practiced."
What a pity that the authors, have treated with thoughtless inattention
this accurate statement when writing about the available therapeutic
options for varicose veins in their otherwise excellent comprehensive
review article.
EPILOGUE. This letter was submitted to the Journal of American Academy of Dermatology (JAAD) for publication 9-20-94. It was assigned the manuscript #94000886. I was requested in a letter dated 9-26-94, to send in a signed copyright transfer agreement which I immediately did. According to the Editor's secretary, Cynthia B. Rossi, the manuscript has been officially forwarded for reply to the first author (Goldman, MP) on October 5, 1994. The Editor (Richard L. Dobson, M.D.) heard from the first author on December 5, 1994. In his letter of December 12, 1994 I was informed that the manuscript was not accepted. While it was not for the love of science, I will allow the reader to speculate on the real reasons for the refusal. My personal opinion is that the Editor gave in to Goldman's demands. Goldman, (and for that matter Weiss as well) are not qualified by their specialty to perform surgery for varicose veins. By recognizing in public that sclerotherapy in any of its forms does not work (the only method they are qualified to perform) would mean basically cutting the branch they and many other members of his organization are sitting on. As to their regard for the patients wellbeing, they and the editor of the JAAD, probably couldn't care less. In my opinion, arrogance, greed and ego have so far prevailed at the expense of the patient. That is obvious if one does follow the many of Goldman's or Weiss' writings (books and articles). To date, none of the above mentioned damaging articles on injection sclerotherapy have ever been mentioned to their readership. What an interesting...coincidence...
References
1. Goldman MP, Weiss RA, Bergan, JJ. Diagnosis and treatment of varicoseveins: A review JAAD 1994; 31:393-413
2. Hobbs JT. Surgery and sclerotherapy in the treatment of varicose veins. Arch Surg 1974; 190:793-6
3. Jakobsen HB. The value of different forms of treatment for varicoseveins. Br J Surg 1979; 66:182-4
4. Einarsson E, Eklof B, Neglen P. Sclerotherapy or surgery as treatmentfor varicose veins: a prospective randomized study. Phlebology 1993; 8:22-6
5. Neglen P, Einarsson E, Eklof B. High tie with sclerotherapy for saphenousvein insufficiency. Phlebology 1986; 1:105-11
6. Goren G. Injection sclerotherapy for varicose veins:history andeffectiveness. Phlebology 1991; 6:7-11
7. Rutgers, P.H., Kitslaar P.J. Randomized trial of stripping versushigh ligation combined withy sclerotherapy in thetreatment of the incompetent greater saphenous vein. Am J Surg 1994; 168:311-15
8. Reymond- Martimbeau P. Two different techniques for sclerosingthe incompetent saphenofemoral junction: acomparative study. J Dermatol Surg Oncol 1990; 16: 626-631
9. Bishop CCR, Fronek HS, Fronek A, et al. Real-time color duplexscanning after sclerotherapy of the greatersaphenous vein. J Vasc. Surg. 1991; 14:505-508
10. Gongolo A, Giraldi E, Buttazzoni L, et al. Il sistema duplex nelfollow up della terapia sclerosante della venagrande safena. Radiol Med 1991; 81: 303-308. ( Italian)
11. Biegeleisen K, Nielsen, RD. Failure of angioscopically guidedsclerotherapy to permanently obliterategreater saphenous varicosity. Phlebology 1994; 9:21-24
12. Goren G, Yellin AE. Primary varicose veins: topographic and hemodynamiccorrelations. J Cardiovasc. Surg. 1990; 31:672-7
13. Oesch A. PIN stripping: a novel method of atraumatic stripping. Phlebology 1993; 8: 171-3
14. Goren G, and Yellin AE. Invaginated axial saphenectomy by a semi-rigidstripper: Pin Stripping.J Vasc Surg 1994; 20:970-7
15. Goren G, Yellin AE. Ambulatory stab evulsion phlebectomy for truncalvaricose veins. Am. J. Surg. 1991; 162:166-174
16. Goren G, Yellin A E. Invaginated axial stripping and stab avulsion(hook) phlebectomy: a definitive outpatient procedure forprimary varicose veins. Amb Surg 1994; 2: 27-35.
17. Goren G. Primary varicose veins: hemodynamic principles of surgicalcare. The case for the ambulatory stab evulsion technique. VASA 1991; 20:365-368
18. Creton D. Study of the limits of local anaesthesia in one-day surgeryin the case of 1500 strippings of the great saphenousvein. Amb Surg 1993; 1:132-35
19. Goren G, Yellin AE. Minimally invasive surgery for primary varicoseveins: limited invaginated axial stripping and tributary(hook) stab avulsion. Ann Vasc Surg; In press. (published 1995;9:410-14)
20. Bergan J J. Clinical application of duplex testing in treatment ofprimary venous stasis, varicose veins. In: Bemmelen PS ,Bergan JJ.: Quantitative measurement of venousincompetence. Austin: R.G. Landes, 1992: 85-6
Information on:
In 1995 the above named journal (recently renamed Dermatologic Surgery) published an article on ambulatory phlebectomy written by three Detroit based osteopathic dermatologists. Totally neglecting reflux control surgery, the Detroit group used the medical publication as well as the lay media (through a public relations firm) to trumpet to the American reader that 1 hour surgery in their offices is all that is necessary to get rid of the medical nuisance called varicose veins.
I decided to write a letter to the editor which I have sent in May 1995 to the editorial desk as instructed by the journal. My letter was farmed out to two reviewers, which is unusual for this type of communication, and, as I have expected, it was refused publication. This time, however, I was determined to fight and air all my grievances. I wrote a detailed letter to the Editor in Chief himself, Dr. Leonard M. Dzubow. Excerpts of my letter to him , a copy of his reply ( inviting me to write a communication ), as well as the communication itself (rewritten this time for added weight with Albert E.Yellin, M.D. Professor of Surgery at USC Medical School ) is reproduced here.
I am happy to report that after 6 months of total silence, we were recently informed by telephone that our communication "The hemodynamic principles of varicose vein therapy" will see print in the July issues of the journal (Dermatologic Surgery). I am also happy to report that judging from the galleys the whole communication, rather long and detailed for a letter format, is going to be published without a single modification. I was notified that Dr. Weiss, rather than the Detroit authors(?), will have a response to our comments. I can hardly hold my breath to read his comments.
August 18, 1995Leonard M. DzubowChief Editor, JDSOPhiladelphia, PA.Dear Doctor Dzubow,
I have recently submitted a Letter to the Editor, hereby enclosed, to your prestigious journal. As I have expected, it was refused publication. I have, however, the feeling that the matter has not crossed your desk, therefore, I am writing to you directly this time.
I wrote the Letter to the Editor as a comment on an article published earlier this year in your journal [1]. Written by a group of osteopathic dermatologists on the subject of ambulatory phlebectomy, the article painted a much too rosy and therefore misleading picture as to what one can accomplish with this technique in cases of primary varicose veins.
With Dr. M. Goldman as the editor of the Phlebology section of your journal and Dr. R. Weiss on the editorial board, my letter probably never had a chance, as we three have met before...
In the July 1993 Dr. Weiss, as a Clinical Professor of Dermatology at the Johns Hopkins University used the tabloid Enquirer to trumpet the "good news to 80 million suffers of varicose veins" The good news was an "only 15 minute office procedure" called "ultrasound guided sclerotherapy" for varicose veins. Naive readers were invited to call the offices of the North American Society of Phlebology (NASP), in which Dr. Weiss ( and Dr. Goldman) hold leading positions, and obtain the names of members of the Society who perform this "wonder" treatment. To my knowledge several thousand people did call or write and were potentially fooled by the above infomercial. I was so outraged at the time that I wrote to Dr. Thomas Provost, Chief of the Department of Dermatology at the Johns Hopkins University with copies to the Dean of the Medical School as well as Rector of the University. I complained that, as a member of the faculty of such a prestigious teaching institution, Dr. Weiss used his academic credentials to knowingly mislead potential consumers. My remarks were substantiated with a rich bibliographic list as to the unacceptably high (60-80%) failure rate of any sclerotherapy procedure for truncal varicose veins. Dr. Provost in his reply, suggested that I write up my objections in the form of an article and send it to one of the major dermatologic journals. The opportunity to make good on his suggestion came one year later with the publication of a review article on varicose veins, in the pages of the JAAD, by the same Drs. Weiss and Goldman [2]. I wrote my comments and objections in the form of a Letter to the Editor that was generously referenced as well. As I have published in the past a review article [3] followed by several short communications [4-6], on the history and effectiveness of sclerotherapy for varicose veins, all I had to do basically, was to add the newly accumulated negative data that the review article skillfully omitted. I was informed by the JAAD editorial desk that my letter was forwarded to the primary author, Dr. Goldman. Two month later, after his reply was finally received, I was told by phone that Dr. Goldman's explanations were good reasons not to publish my comments... Now you can understand that, when I recently submitted my objection to the article on ambulatory phlebectomy printed in your journal, I was not expecting much...
The real issue is not whether my letter to your prestigious journal was or was not published. The real issue is that Drs. Weiss, Goldman together with the NASP organization which they head, will do everything possible to obstruct any objective evidence which is against their views and interests. This organization gives shelter to the most corrupt practitioners among us, those who have falsely advertised and mislead for years scores of naive sufferers. I am referring to the present and former members of the infamous Vein Clinics of America, who finally, in 1994, were cited by the Federal Trade Commission for false advertisement.
Both two above mentioned physicians as well as the majority of the NASP members will do everything possible to defend their lack of surgical skills and keep the subject in their territory. The fact that this means cheating and misleading the naive public who seeks help, is besides the point, and is permitted.
As long as they can, they will not reveal either to their peers or to the public the failure of sclerotherapy in treating truncal varicose veins. But shrewd as they are, they see that the pendulum is slowly shifting and swinging back to surgery so now, they are doing everything possible to convince their peers as well as the naive consumer that the surgical ambulatory phlebectomy is a dermatological procedure as well and that they, without meaningful surgical training, are fully qualified to undertake such treatment.
I will not repeat myself; all my objections to the contrary are in my Letter to the Editor which I have submitted to your journal. I will only say that for any procedure meant to treat varicose veins and stand the trial of time, reflux control is mandatory when sapheno-femoral or sapheno-popliteal junctional incompetence is present. This is the situation in at least 80% of cases of primary varicose veins [7]. Sclerotherapy, which basically is thrombotherapy, fails because the formed clot will control the reflux for only for a short period of time if at all. After lysis of the clot, the reflux is reestablished and the varicosities will "blosom" again. Anatomically, however, these two junctions, one in the groin the other in the popliteal fossa, are surrounded by very delicate structures. Surgeons, even big name surgeons, have gotten in trouble and transected femoral veins, femoral arteries even, yes, stripped by mistake the femoral artery with catastrophic consequences.
So what will non surgeons do, like the authors of the article published in your journal? Due to technical difficulties, they may opt not to perform reflux control surgery ( high ligation and stripping) and expose the patient to early recurrences exactly like sclerotherapy or perform it badly and expose the patient to possible catastrophic consequences. You have to agree with me that neither of these two options are ethical or moral!
I had the opportunity, just 10 days ago, to demonstrate how long saphenous varicose veins should be operated in an office setting under local anesthesia (ligation of the sapheno-femoral junction, followed by segmental invaginated stripping and ambulatory phlebectomy for the varicose tributaries) to Dr. Carlos Garcia from the Dermatologic Surgical Unit, Duke Hospital South, of Durham, N. C. He was referred to me by Dr. Duffy of Torrance, with whom he spent some time. He told me, after he saw the whole operation, that the phlebological literature to which he is exposed through the dermatological publications have simply confused him (and his colleagues) completely. He recognized immediately that in order for him to perform what he saw in my office, he would have to enlist the services of a qualified surgeon. What a pity that honest people like Dr. Garcia* are prevented from being exposed to critical opinions besides the opinions of Drs. Weiss' or Goldman's whose egos and interests do not permit the whole picture to surface. I am ready to send you a video tape I recently produced on the procedure as depicted in my last publication published on the pages of this past July's issue of the Annals of Vascular Surgery. See it and decide for yourself whether anyone in his/her right mind, also moral and ethical, would perform such a procedure without proper surgical training.
Doctor Dzubow, I have had great satisfaction since I have dedicated myself completely to vein disorders eleven years ago.
Professionally, I have a rewarding and busy practice. I have a fairly good reputation and I am self sufficient in my office. My fees, ($1900 maximum a leg) are less than the 20% copayment a fully insured patient would have to pay, in my geographic area, if he would have the operation in a hospital (day care) setting.
Academically, I have contributed nicely to the phlebological literature in general and ambulatory phlebectomy [8-14] in particular in the last 5 years. My 1991 fist article on ambulatory phlebectomy [8] was also first on the subject in the American surgical literature and my last one, the seventh[14] just out of print, I hope it will be a classic for many years to come. I also hold workshops in my office and since 1988 and had so far 436 surgeons participate in spite the fact that I cannot give CME credits as I am not affiliated with any teaching institutions.
I am, however, literally disgusted how a group of physicians in the name of ego and greed can mislead themselves, other colleagues and naive consumers. I will not remain silent anymore. These morally and ethically corrupt practitioners, whoever they are, will have to be stopped in preying on naive consumers and I will use all the existing legal means to expose them loud and clear.
I know how busy you are, therefore, I thank you for your attention. While no reply is necessary, I would certainly welcome one.
REFERENCES.
1. Cohn MS, Sieger E, Goldman S. Ambulatory phlebectomy using the tumescent technique of local anesthesia. J Dermatol Surg Oncol 1995; 21: 315-18
2. Goldman MP, Weiss RA, Bergan, JJ. Diagnosis and treatment of varicose veins: A review JAAD 1994; 31:393-413
3. Goren, G. Injection sclerotherapy for Varicose veins: history and effectiveness. Phlebology 1991, 6: 7-11
4. Goren, G. "Real time color duplex scanning following sclerotherapy of the greater saphenous vein" Letter to the Editor, J Vasc Surg 1992; 16:497-8
5. Goren, G. Injection sclerotherapy revisited. Letter to the Editor. Phlebology 1992; 7:131-132
6. Goren, G. Injection sclerotherapy re-revisited. Letter to Editor Phlebology 1993; 8:91-2
7. Goren, G. Yellin, A.E. Primary varicose veins : topographic and hemodynamic correlations. J Cardiovasc Surg., 1990; 31:672-77 Selected and also published in Phlebological Digest 1991; 3:22-24
8. Goren, G. Yellin, A.E. Surgery for truncal varicose veins: The ambulatory stab evulsion phlebectomy. Am J Surg 1991; 162:166-74 Selected and published also in the Year Book of Vascular Surgery, John M. Porter Ed. 1993; 385-7
9. Goren, G. Primary varicose veins: hemodynamic principles of surgical care. VASA 1991; 20:365-68 Selected and also published in Phlebological Digest 1992;
10. Goren, G. Taming varicose vein surgery. Letter to Editor. Phlebology 1993; 8:136-8
11. Goren, G. Yellin, A.E. Invaginated axial stripping and stab avulsion phlebectomy: a definitive outpatient procedure for varicose veins. Amb Surg 1994; 2 (1) 27-35
12. Goren, G. Invaginated PIN stripping. Letter to Editor. Phlebology 1994; 9:173-4
13. Goren, G. Yellin, A.E. Invaginated axial saphenectomy by a semi-rigid stripper: PIN stripping. J Vasc Surg 1994; 20:970-7
14. Goren, G. Yellin, A.E. Minimally invasive surgery for primary varicose veins: limitted invaginated axial stripping and tributary (hook) stab avulsion. Ann Vasc Surg 1995; 9:401-14
HEMODYNAMIC PRINCIPLES OF VARICOSE VEIN THERAPY
Gabriel Goren* and Albert E. Yellin**
*Director, Vein Disorders Center Encino, California ** Professor of SurgeryUSC School of MedicineDirector, Surgical ServicesLA County-USC Medical CenterLos Angeles, California
Primary varicose veins (PVV) affect 10-15% of our population. In addition to pain, edema and superficial phlebitis, etc. they can cause chronic venous insufficiency (CVI). Indeed, in one series, PVV represented the sole etiological factor in 42 (53%) of 79 ulcerated limbs [1]. Therefore, proper treatment, based on sound hemodynamic principles, is imperative if the problem is to be permanently eradicated.
Primary varicose veins are hemodynamically characterized by the existence of a retrograde circuit . This was first described by Trendelenburg over 100 years ago [2]. Tibbs [3] using continuous wave Doppler ultrasound and Hach [4] using ascending press phlebography, further expanded our understanding of the hemodynamic pathophysiology of PVV.
The retrograde circuit (RC) consists of a proximal start-reflux (escape) point, usually located at the level of an incompetent junction, through which blood from the deep system is shunted into the superficial saphenous vein(s). This terminates at the end-reflux point where the incompetence of the saphenous trunk(s) ends. The segment of vein trunk between these two points represents the axial reflux. Based on the anatomical location of the end-reflux point, Hach [5] classified long saphenous vein (LSV) into 4 and short saphenous vein (SSV) varicosities into 3 different grades. Rarely did the end-reflux point reach the level of the ankle (LSV grade IV and SSV grade III). In most cases reflux terminated higher (groin-grade I; mid thigh-grade II and upper calf-grade III), confining the axial reflux to a much shorter segment of the main long saphenous trunk. Only long axial reflux varicosities (LSV grade III and IV and SSV grade III), causing volume overload decompensation and secondary incompetence of the deep system, can lead to CVI changes [6-8].The last constituent of the RC is the reentry point(s), an inwardly flowing perforator(s) that drains the retrograde saphenous flow back into the deep veins.
Bjordal's concomitant invasive flow and pressure measurements [9-11] demonstrated that, in PVV, during the diastolic phase of the walking cycle, blood streams downward (average 300ml/min) and the ambulatory venous pressure (AVP) in the distal saphenous system, perforators included, remains elevated. Only occlusion of the proximal escape point will normalize the elevated AVP by abolishing the regurgitant flow. In other words, in PVV the increased AVP is caused by the reversed saphenous flow and not by incompetent perforator(s) causing outward flow from the deep to the superficial veins [12-13].
Theoretically, with incompetence and reflux confined to the superficial venous system, varicose veins should be easy to treat. For long term efficacy any therapeutic procedure must achieve hemodynamic optimization by abolishing the offending regurgitant flow (reflux) responsible for the elevated AVP. Since venous competence cannot be restored, the varicosities must be either permanently obliterated by sclerotherapy or ligated and removed by surgery.
Injection sclerotherapy (IST) is an appealing therapeutic modality since shifts treatment away from costly hospital care. Unfortunately, it is associated with unacceptably high failure rates. Prospective randomized clinical studies of Hobbs [14] in 1974; Jakobsen [15] in 1979; and Einarson et al. [16] in 1993 have reported 5 year failure rates of 63 to 74% compared to only 10 to 20% for traditional stripping. Studies of Jakobsen [15] in 1979; Neglen et al.[17] in 1986; Goren [18] in 1991; Rutgers and Kitslaar [19] in 1994 reported similar unacceptably high failure rates of 40-50% even when surgical ligation of refluxing junctions was combined with tributary sclerotherapy.
The most conclusive damaging data came with publication of three recent studies that used duplex imaging to assess the therapeutic outcome of IST rather then rely on the traditional subjective visual assessment and finger palpation that invariably produced "excellent" results [20]. The studies of Bishop et al. [21] and Gongolo et al. [22] in 1991, reported reestablishment of reflux after only 2 years of follow up in 80% and 63% of cases respectively In 1994 Biegeleisen [23], using selective angioscopic, rather then percutaneous delivery of the sclerosing agent reported a 100% failure rate of IST in controlling long saphenous axial reflux. Thus IST fails, even when the injection has been selectively delivered to the source of offending incompetence and reflux. Based on these data the likely efficacy of duplex guided IST, an expensive and unproven form of IST (echosclerotherapy), is more than doubtful. The failure of IST is not delivery dependent but rather caused by the temporary thrombogenic and phlebitogenic properties of all sclerosing agents following endothelial injury. After lysis of the clot ("transient thrombotherapy") reflux is usually reestablished and varicosities will "blossom" again. It is our belief that with failure rates of 63 to 100%, IST cannot be considered a viable ethical therapeutic option for PVV, at least not in the hands of a responsible practitioner.
A recent elaborate review article on the diagnosis and treatment modalities of PVV printed in a prestigious dermatologic journal and authored by well known practitioners [24] omitted referencing most of the above enumerated scientific evidence disproving efficacy of IST although they were published in highly visible professional journals [14-19, 21,23]. Bergan [25], one of the coauthors of the review article in question, in a previous writing summed up the fate of IST with an accurate statement that needs no further comment: "It is anticipated that pure sclerotherapy in the treatment of varicosities to the exclusion of other modalities will not gain acceptance in institutions where critical review of results is practiced". The authors failed, however, to mention this accurate statement when writing about the therapeutic options of PVV in their otherwise excellent comprehensive review article.
Surgery remains, therefore, the only current effective method of choice in the treatment of PVV. Although performance of the classical Babcock / Myers [26] ankle to groin stripping confers excellent long term results [27] the oversized acorn shaped intraluminal stripper head causes major soft tissue trauma and is responsible for the postoperative morbidity and prolonged convalescence. In addition it is also a cause of injury to the saphenous or sural nerves. Concurrent removal of the varicose tributaries via generous skin incisions adds to the trauma and may result in undesirable scarring as well. Performed under general anesthesia and in a hospital setting this traditional approach is costly.
Based on the already cited hemodynamic evidence [3-6, 9-13], in most cases of PVV, following junctional ligations a stripping limited to the length of the axial reflux of the long [28-32] and short [ 33 ] saphenous trunks, will be sufficient. The classical blind ankle to groin stripping is unnecessary "overkill". The reintroduction of stripping by invagination via a nylon filament by van der Stricht [34] drastically reduced operative trauma and nerve injury [35]. PIN stripping, the recently reported invagination technique of Oesch [36] further eliminated the need to expose the distal saphenous trunk and visualize the far end of the stripper. The introduction of stab avulsion for the varicose tributaries additionally reduced the operative trauma and improved cosmesis. Whereas Rivlin [29] ("multiple cosmetic varicectomy") avulsed the varicosities with small, makeshift, instrumentation, it was Muller [37] ("phlebectomie ambulatoire") who first introduced the phlebextractor hooks. Complete protocols for this minimally invasive and cost efficient surgery performed under loco-regional anesthesia and in an office setting have been published by us [38-41].
In 1929 Homans [42] stated that the surgical "profession has taken a lazy man's attitude towards the varix of the leg". Moreover, once performed, "the operation was relegated to the end of the operating list and delegated to the surgical tyro" [43]. Unfortunately, this cavalier attitude still persists.
It comes as no surprise, therefore, that disciplines other than surgical specialties are eager to treat the condition. We read, therefore, with interest the article on ambulatory phlebectomy using tumescent local anesthesia that was recently published in your journal by a group of osteopathic dermatologists [44].
Tumescent anesthesia [45] is an excellent method for large, potentially bleeding, surfaces encountered in liposuction, dermabrasion, or flap surgery. Its use in varicose vein surgery is perhaps questionable. In our hands the indurated subcutaneous tissues represent an obstacle to effective hook phlebextraction. For long saphenous varicosities we prefer the femoral block anesthesia [46] successfully used by others as well [47]. For the short saphenous vein surgery we use simple infiltrative anesthesia although sciatic block is an excellent and simple alternative [48].
Our major criticism, however, relates to the misleading overly simple message a patient or a practitioner gets after reading the article, which was also publicized in lay publications countrywide. The authors accept the failure of sclerotherapy and offer ambulatory phlebectomy as the simple alternative for all forms of PVV. They suggest that all one needs is an unassuming office, local anesthesia and a few phlebextractor hooks. This simple protocol omits, however, several key hemodynamic issues.
A hemodynamically correct treatment protocol implies control of the escape point by surgical ligation and control of existing axial reflux by some form of stripping (reflux control surgery), before attempting to remove the varicose tributaries by the hook phlebextraction ( ambulatory phlebectomy) technique.
In over 850 cases of PVV operated in the last five years, Doppler ultrasound examination localized the escape point in the groin at the sapheno-femoral junction (SFJ) in 74 % representing ten percent more than we previously reported on 230 limbs [49]. The incidence of sapheno-popliteal junction (SPJ) remained at 8%. Dimakakos et al. [50] in a series of 2300(!) limbs with PVV reported an almost identical distribution of incompetence:71.75% for SFJ and 8.3% for SPJ. Perrin [51], in a series of 317 varicose legs reported an incidence of incompetent SFJ in 68.7% and SPJ in 18.5%. Therefore, the suggested ambulatory phlebectomy is hemodynamically appropriate in less than 20% of patients with PVV. The remaining 80% of patients with clear junctional and trunk incompetence (axial reflux) will undergo inadequate treatment if only ambulatory phlebectomy without proper reflux control surgery is performed.
One has to remember that the groin and popliteal fossa harbor delicate and vital structures such as the femoral artery, femoral vein, popliteal vein, tibial nerve etc. Therefore, junctional ligations require technical skills that only general or vascular surgeons acquire during their residency and/or fellowship. Muller, himself a dermatologist, stated in his first publication in 1966, that all varicosities displaying sapheno-femoral junctional incompetence are left for the surgeon "pour une crossectomie suivie d'un stripping externe selon Mayo..." or, "for a junctional ligation followed by external stripping of Mayo..." the method of stripping he probably preferred at the time [37]. Attempts to practice hook phlebextraction of incompetent saphenous trunks after junctional ligation have been described [38]. This procedure can be technically challenging, as thighs come in different sizes. The long saphenous vein trunk, always localized beneath the membranous fascia, can often be inaccessible to hook extraction. The short saphenous trunk, completely subfascial at its termination, cannot be hooked in the proximal calf unless the fascia is opened as well. The unorthodox avulsion of the SPJ (!) was also suggested by non-surgeons to the readers of your journal in the recent past [52]. This invites unnecessary complications.
Based on the principles of the regurgitant circuit, varicose veins mimic a waterfall. The escape point is equivalent to the top of the hill proximal source of downpour, and the varicose tributaries are equivalent to the bottom of the hill, creating pool(s), that all waterfalls have. By analogy, siphoning the water from the pools at the bottom of the hill, without capping the flow at the top of the hill, will result in rapidly refilled pools. Transposed to PVV, removing the varicose tributaries by hook phlebextraction (ambulatory phlebectomy) and leaving the proximal escape points "dripping", as proposed in the article, represents a hemodynamic compromise which will lead to early recurrences.
A technically faulty reflux procedure during "high ligation" is reported in 70-80% of all cases of recurrent varicose veins. Excellent results are dependent on the training, skill, and experience of the surgeon. Similarly, the above reported high failure rate of injection sclerotherapy is due to the inability of the method to provide long term control of the offending proximal reflux, regardless of its delivery method.
Varicose veins are not just a simple subcuticular structures that will respond to a minimal and incomplete manipulations performed under local anesthesia. Knowledge of hemodynamics, of non-invasive diagnostic modalities (for mapping the source and course of the axial reflux) and tediously acquired technical skills are essential for a successful and long lasting therapeutic outcome. Ambulatory phlebectomy without proper reflux control surgery will fail as IST does. Cost efficiency is important, but not at the expense of the patient.
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SUMMARY OF DR WEISS REPLY AND COMMENTS
I am indebted to the Editor in Chief of the the journal Dermatologic Surgery, Dr. Leonard M. Dzubow. He has proved to be an impartial , as a Chief Editor should be. Without his personal intervention, the Weisses and the Goldmans would never have enabled publication of a different point of view (especially from me, the M. P. Goldman long declared archenemy of the NASP) who could have potentially undermined their arrogant stand on phlebological key issues.
The reply by the designated responders (in lieu of the Detroit based ostheopatics dermatologists, the actual authors) was weak and shallow. The Weisses have tried hard to offset the inflicted TKO in their own territory. They defended sclerotherapy by invoking the long invalid subjective proofs of Fegan from the sixties and Doran and White from the seventies. However, the new damaging (to their cause) objective randomized studies of Einarsson, Ekl'f and Neglen (1993) and of Rutgers and Kitslaar (1994) as well as the similarly objective duplex as well as angioscopic/duplex studies of Gongolo (1991) and respectively Biegelisen (1994) were, as it was expected, deliberately omitted from the reference list. By the way over 30% of their bibliography was outdated and preceded 1980.
As to ambulatory phlebectomy, they can not comprehend that hook stab avulsion is meant only for the varicose tributaries and that only proper reflux surgery ( that they are not qualified to perform) will guarantee the long term success of the procedure. Muller is deified as Tournay was just a few years ago. Yes, he introduced the phlebectomy hooks, no one denies this. The reason he was put down, for years, by the surgical establishment of his own country Switzerland, was that he used completely unorthodox "surgical" techniques, such as operating with his hooks held in his...mouth. The fact that Rivlin the British surgeon ( 2000 operated cases published in 1975) operates since the fifties using minimal skin openings to avulse the varicose tributaries with small makeshift and ophtalmic instruments ( "multiple cosmetic varicectomy") bears no importance to the designated responders. Muller was honest enough to recognize that reflux surgery has to be delegated to the surgeon; however, the designated responders have not expressed such moral inclinations. Possibly I was expecting too much from a group of practitioners who are basically surgically...challenged and will do everything in their position to defend their position around the ...watering hole. Ego, greed and arrogance prevailed once more. The patients' well being remains a completely secondary issue. Do I exaggerate? NOT AT ALL! The reader is invited to read the next paragraph which is about a Weiss and Goldman clone (Carlos Garcia) ready for action, and possibly even in action by now...
As I believe vein disorders / diseases are surgical conditions, I never opened my office or for that matter the workshops to non-surgeons. During the nine years I have been holding them only a handful of non surgeons have participated and Carlos Garcia, M.D. a dermatologist from Duke University was among the privileged few. Referred by a physician I could not refuse, he observed a surgery for varicose veins and then a few weeks later participated in the November 1995 workshop. During our extensive talks, Dr. Garcia expressed his hope to organize a Vein Center at the University but fully agreed with me that that because of his lack of surgical skills, for the mandatory reflux control surgery (junction ligation and stripping) needed in over 80% cases of varicose veins, he would certainly enlist the services of a local general or vascular surgeon.
Less than two months later, however, he drastically changed his mind and concluded, that it would be just fine for him to be the only surgeon performing the entire varicose vein surgery. In his letter to me January 4, 1996, Dr. Garcia also respectfully requested that I should agree to have him for an additional two weeks of apprenticeship in my office. This would supplement the several visits he already made to the anatomy room... where he dissected several saphenous vein terminations. Besides, as a spider vein injector for years and after extensive dermatologic surgical background he felt he could do proper varicose vein surgery ligation and stripping included...
I was totally dismayed as he is not a private practitioner but a university based physician supposed to be guided by even higher standards of conduct. I wrote him and also alerted Robert Anderson M.D., Professor and Chairman Department of Surgery, Duke University Medical Center of his intentions. My letter to Dr. Garcia is reproduced here.
January 4, 1996Carlos Garcia, M.D. Dermatological Surgical UnitRoom 04265, Duke Hospital SouthDurham, N.C.27710Dear Doctor Garcia,
I am literally appalled by your decision. What bothers me is your total disconsideration towards your prospective patients. If you think that Mohs surgery background and some additional 2 weeks of observation in my office would be sufficient to unleash your new surgical skills on patients, you are mistaken. I don't have to stress to you that ligation of junctions (SFJ and SPJ) require a little bit more surgical skills than your background will ever entitle you. Certified vascular surgeons have transected femoral veins and arteries and even stripped the femoral artery. Would you know what to do if you would have nicked the "just" the femoral vein and have a profuse bleeding or you will through your hands up and call for help? Have you ever done a vascular anastomosis? Do you know how to suture a blood vessel?
I think you have forgotten what the axiom "primum nil nocere" means. In plain English it means "do not harm" the patient, of course. You are ready for whatever reasons (ego, greed or both) to forego on all this. That is your problem. I will, however, play no part in this.
Sincerely, G. Goren, M.D.
Even when these lines are written ( May1996) the decades long cavalier attitude of the surgical establishment towards vein disorders in general and varicose veins in particular, remains unchanged. While most major university vascular surgery departments will offer the latest advances in arterial surgery including angioscopy, endovascular stenting and laser endarterectomies etc. the sufferer of varicose veins is offered by the same settings a surgical procedure (blind ankle to groin stripping) which is by now 90 years old...and is associated with trauma, convalescence, loss of income, neurologic complications and occasionally ugly scarring not to speak of cost inefficiency.
This attitude opens the door for nonsurgical specialties to try to put their hands on this surgical pathology solely because of greed, ego, or both. What about the patient and his well being? Apparently in the above cited cases this was not, and, if you ask my opinion, it will never be an issue!
