Varicose veins are a common disorder,

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1 Vol. 1 No. 1 An International Dialogue Management of venous disease is a dynamically changing field. At the start of the 21 st century, minimally invasive endovascular procedures are emerging as the dominant approach to vascular disease management. However, this change in focus has not been without some debate and discussion. Therefore, a new serial publication Venous Diseases: An International Dialogue has been developed with the goal of helping physicians and surgeons keep abreast of this ever-changing field. In our inaugural issue, Prof. Kolvenbach discusses the changing concepts in varicose vein surgery. In this area there is considerable debate on the use of conservative approaches versus surgical intervention. According to Prof. Kolvenbach, for the surgical approach to treating varicose veins to compete with other less invasive interventions, it will become increasingly important to assess the clinical and economic outcomes of new surgical techniques. Our Symposium features four vascular surgeons, working in diverse settings, discussing their initial experiences with minimally invasive techniques in the treatment of venous insufficiency. Advisory Board Members NJW Cheshire MD FRCS Consultant Vascular Surgeon St. Mary s Hospital, London, UK William R. Finkelmeier MD Medical Director, Vein Solutions Carmel Medical Center Carmel, IN, USA Joseph F. Iovino MD South Shore Surgical Specialists South Weymouth, MA, USA Ralf Kolvenbach, MD, PhD Chief Vascular Surgery & Phlebology Augusta Hospital, Dusseldorf, GE Praskash Madhaven MBBS FRCSEd, FRCS Consultant Vascular Surgeon St. James Hospital, Dublin, IR Doug McWhinnie MD FRCS Consultant Vascular Surgeon Milton Keynes General NHS Trust Hospital Milton Keyes, Buckinghamshire, UK Changing Concepts in Varicose Vein Surgery By Ralf Kolvenbach MD, PhD Varicose veins are a common disorder, affecting an estimated 15% of adults, primarily women who have been pregnant. 1 A number of factors should be weighed in choosing a treatment for varicose veins, including some consideration of the role of economics in venous therapy. Patients typically are referred either to a phlebologist, dermatologist, general surgeon, or vascular surgeon. There is no general consensus on when therapeutic intervention for varicose veins is appropriate, a situation with considerable implications for the best use of resources. Many patients currently are being told that radical surgical treatment could worsen their symptoms and are strongly urged to choose more conservative therapy as an alternative. In order for the surgical approach to treating varicose veins to compete with other less invasive interventions, it will become increasingly important to assess the clinical and economic outcomes of new surgical techniques. Relevant Questions The proper use of more conservative treatment protocols has been a point of strong controversy between two groups of advocates. On one side are the phlebologists, who use sclerotherapy as the primary treatment for varicose veins of all sizes and etiologies. On the other side are surgeons, who advocate a surgical approach for patients with what must be considered an incurable disease. Dodd summed up one of the problems associated with sclerotherapy as it is currently being used when he stated the worst aspects of injection therapy are seen when varicose vein cases are herded The time has come to subject therapeutic options for the treatment of varicose veins to rigorous economic assessments. into injection clinics without appropriate follow up. 2 Hobbs 3 conducted a randomized trial at St. Mary s Hospital in London in which he compared venous surgery and sclerotherapy. During a 6-year follow-up study, he found remnant or recurrent varicosities in more than 90% of the injected legs versus 16% of the surgically treated group. No one questions the fact that injection therapy has a beneficial role when treating small (<3 4 mm) side branches or reticular varicosities. However, an increasing number of patients are being admitted for surgery following a failed attempt to use sclerotherapy in the saphenofemoral junction or in one of the large veins of the proximal thigh. The introduction of several new devices for venous surgery seriously challenges existing paradigms. A number of Continued on page 6

2 Symposium on Venous Diseases Symposium is an international dialogue among health professionals working extensively in venous disorders. Initial Experiences with New Minimally Invasive Techniques Moderator: Steve Elias, MD, FACS Panelists: Nick Cheshire, MD, FRCS Prakash Madhavan, FRCSEd, FRCS William Marston, MD Abstract: When new minimally invasive surgical techniques are introduced, it can be difficult for the practicing surgeon to evaluate them and, assuming they are found to be of benefit, to incorporate them into standard practice. The panelists discuss how each of them has approached the challenge of introducing some of these new approaches, such as endovascular aortoc repair (EVAR), endoscopic perforator surgery (SEPS), and transilluminated power phlebectomy (TriVex ), the panelists explained the subsequent steps they took to educate other surgeons, OR personnel, and patients about the relative benefits of these new minimally invasive technologies. Future research comparing these new techniques with current practice should establish their relative efficacy. Elias: A surgeon s initial experiences with learning new, minimally invasive surgical techniques is an interesting topic that is not often discussed openly. Our purpose today is not to focus on reported results but rather to share our initial thoughts and concerns about these new techniques. This includes the challenge involved in the nuts and bolts of learning a new technology and teaching it to others. The members of this panel have been involved from the beginning with new techniques, devices, and novel approaches to managing vascular problems. You have adopted some of the new technologies, while rejecting others. At times you have improved upon new techniques. It is important for surgeons to share which aspects of a new technique make them say, I think that makes sense. I ll try it. Then, once you feel comfortable with new techniques, how do you share the knowledge gained through your personal experience with other surgeons and OR personnel to help accelerate their learning curve? Historically, surgery has been about passing on knowledge to those who need it. However, with these new techniques, it is important that this educational process not take years. Actually, months, weeks, or days are more reasonable in today s fast-paced medical environment. In this symposium, we will discuss a number of issues that are important to surgeons who are dedicated to providing optimum new treatment. Elias: You have had early experience with some minimally invasive vascular technologies. What are some of these? Madhavan: I have been involved with minimally invasive vascular surgery for the last six years. At a time when most vascular surgeons were shying away from acquiring endovascular skills, the units in which It is critically important to determine the risk-benefit ratio of the less invasive therapy compared with the standard technique. William R. Marston I was training in Ireland were at the forefront of such techniques. I currently work in an environment that would be alien to most vascular surgeons since the majority of the endovascular interventions in our unit are surgeon-driven and performed. In my vascular surgical practice, I routinely carry out transluminal and subintimal angioplasty, percutaneous thrombolysis, endovascular aortic stent grafting, sub-fascial endoscopic perforator surgery, mini-incision aortic surgery, and TriVex. Cheshire: We have experience with endovascular aortic repair, or EVAR, and carotid stent programs as well as having a subintimal angioplasty practice. We also have growing experience with total intracorporeal and hand-assisted laparoscopic aorto-iliac surgery. On the venous side, we regularly use subfascial endoscopic perforator surgery, or SEPS, and TriVex. We have very limited experience with the VNUS Closure device. Marston: I have had experience with a wide range of endovascular techniques, including angioplasty, stent, and stent-graft 2

3 systems. In all of these technologies, it is critically important to determine the riskbenefit ratio of the less invasive therapy compared with the standard technique. The minimally invasive technique is useful if its results are sufficiently good and the reduction in risk is significant. In some situations, however, this type of analysis does not lead to a positive conclusion. Therefore, each technique must be carefully evaluated on its own merit, and must not be recommended just because it is labeled as new or less invasive. Elias: Bill, you make a good point. Nick s experience with hand-assisted laparoscopic aorto-iliac surgery is a good example of taking the benefits from a few less invasive technologies and incorporating them into a new procedure. Elias: When introducing a new technology to the OR staff, what general points do you make it a point to highlight? What is your approach? Elias: Personally, I meet with all OR personnel involved to review the indications for the procedure and to go over the technique. I also think it is important to let the personnel know that a new technique represents a learning experience for all of us. Madhavan: In order to successfully introduce any new technique into the operating room environment, the entire team must be involved. I typically begin by introducing the new technology to the staff members who will be involved with it. Next, I arrange for a representative of the company manufacturing the equipment to visit and provide a further briefing. Finally, we have dry run in which we actually use the equipment in the operating theater. It is essential that OR personnel be aware of the benefits of any new procedure if they are to embrace it. In addition, I try to involve other members of the treatment team, such as the nursing staff on the wards, who are responsible for providing postoperative care. It can be difficult for nurses to care for patients who have undergone procedures that may be radically different from conventional surgical techniques. It is important to educate and inform these staff members about any new technique being used. Marston: Clearly, it is important for the OR staff to understand the goals of a new technique as well as the technical points of operating new equipment. Depending on the technical difficulty of the new procedure, it is often useful to bring in experienced personnel from another hospital to lend their expertise, thereby speeding up the staff s learning curve during the initial cases. It is also critical to use the same team with each procedure during the familiarization period. These individuals can then provide internal education for other OR staff. Before surgeons can adopt a completely new technique, they must be appropriately trained in workshops and other programs. Prakash Madhavan Cheshire: In the UK, we use much the same approach as the rest of you. I try to include all medical and nursing personnel from both the OR and the ward in the development plans. I have found presentations, video, and models to be extremely useful in accomplishing the education process. I also think it is essential to allow sufficient OR time when a new technology is first being used so that the staff do not feel pressured during the procedure. Elias: How did you initially begin utilizing transilluminated powered phlebectomy, or TriVex, in your hospital? Marston: I began using the transilluminated powered phlebectomy system as part of a multicenter trial. We enrolled patients and documented the results obtained by using this technique. Elias: I also played a part in the initial TriVex clinical trial and feel that it was to our advantage to have been involved early. Clinical trials can be comforting to the surgeon in that patients know that this is something new to you as well as to them. Dealing with a new technique can be somewhat daunting for a surgeon. Cheshire: I actually visited Greg Spitz in Illinois before the TriVex system had been fully developed. I was so enthused about TriVex that I did my first case using an orthopedic resector and a urology light source. Of course, this is not an approach I would recommend now although the outcome was very good. After that, Greg came over to St. Mary s and proctored a number of cases, which was really useful for all the team. We next ran a number of teaching courses for British surgeons, which proved to be popular. The programs turned out to be educational for all of us, not just for the delegates. Madhavan: We first became aware of TriVex at a scientific meeting. After looking at the technique, we initially attended a course held at St. Mary s in London before traveling to meet Greg Spitz in Aurora, Illinois. We spent a day with Greg in the operating theater looking at the technique. After we returned, we carried out a pilot study on 20 patients. At that stage, we were happy that the technique was a viable one and decided to incorporate it into our practice. Elias: There are technologies that are totally new meaning that they are not a variation on existing procedures and those that build on the surgeon s past experience. Do you approach these two types of technologies differently? Madhavan: I certainly do approach these types of technologies differently. Before surgeons can adopt a completely new technique, they must be appropriately trained in workshops and other programs. The question of adapting an existing surgical procedure is altogether different since the surgeon is simply using an accepted procedure in a modified fashion. For example, conventional aortic surgery involves making an incision from xiphisternum to pubic symphysis. Mini-incision 3

4 aortic surgery, on the other hand, can be performed through a 4 to 5 inch incision, using exactly the same instruments. Cheshire: I am much less apprehensive about a technology that builds on past experience. In addition, I find it easier to introduce this concept to patients and colleagues. When totally new techniques are first introduced, I prefer to approach the issue as if it were a research project, including obtaining approval from the ethical committee and developing a widely accepted consent process. I find it particularly difficult to introduce totally new techniques if there are not some national or global data, such as registry data, that can be used to inform patients about outcomes. Elias: When teaching new technologies, I tell surgeons that if the technology makes sense, work through the learning curve before you judge the technology. I think that getting a surgeon to be comfortable is important. Do you agree? What is your approach? Cheshire: I totally agree with you steve. It often takes me some time and experience before I can fully appreciate the strengths and weaknesses of a new approach. Madhavan: I am also in complete agreement with Steve s approach. Before surgeons can pass judgment on a new technique, they first need to carry out the procedure and then to evaluate the results. None of us can come to a verdict about a procedure before we have come to grips with it. We have to withhold our judgment until we have taken the time to work through the learning curve. Marston: I think that a new technology should be judged on the basis of the results it offers the patient. Most procedures are not particularly difficult to do once a significant number of cases have been performed and you have become familiar with the technique. Therefore, it seems to me that the critical information would have to be the potential benefit the procedure offers the patient. If there are data to document this benefit and it is significant surgeons should offer the new technique to their patients. If no such data exist, the surgeon may consider becoming involved in a study to help validate the technology or choose to wait until data are available in order to evaluate the technology appropriately. Elias: It may be a case of comparing apples to oranges, but can you compare or contrast your initial experiences with transilluminated powered phlebectomy and endovascular aneurysm repair, or EVAR? I was more comfortable with the introduction of TriVex than EVAR because it represents less of a deviation from normal practice. Nick Cheshire Marston: It is difficult to compare these procedures because one is reconstructive and the other is an ablative procedure. With EVAR, the critical question has always been whether the stent-graft systems would perform well in the long run. Therefore, we need 5- and 10-year followup data in order to evaluate this technique. EVAR clearly has some short-term benefits for high-risk patients, but we still do not know how these devices compare to standard surgery. Since the question with TriVex is focused more on operative results, a 6-month follow-up is adequate to judge the benefit of this technique. I felt that the TriVex technique made sense. Then, the multicenter study provided a way to answer a straightforward question about the value of this procedure. We would have known within a few months if the complication rates or patient satisfaction scores had been unacceptable, giving us the option of refining or abandoning the technique. Fortunately, this did not happen. Cheshire: Personally, I was more comfortable with the introduction of TriVex than EVAR because it represents less of a deviation from normal practice. Compared to EVAR, TriVex allows me to feel more in control of each individual procedure. With EVAR, the role of the radiologist, input from the manufacturer, and the quality of imaging are all somewhat out of surgical control. I also found it easier to discuss TriVex with patients because the concept is rather more obvious. On the other hand, since EVAR has a greater potential impact and major resource requirements than TriVex, it has attracted more attention within the health service. Another difference was that because we initiated TriVex very early in its genesis, we were trying to get the message about this technique out to referring physicians and patients. In contrast, many referring physicians and patients were already aware of EVAR and came to us specifically seeking this procedure. This introduced a subtle, but important, difference into the relationship between surgeon and patient. Madhavan: Although supporters of both techniques initially felt that they would replace conventional surgery, that clearly has not been the case. Once the initial enthusiasm for a new procedure settles down, its true value and viability become apparent. In my opinion TriVex and EVAR will not replace conventional surgery but will each find a niche where they will become the treatment of choice. Elias: What have you learned over your years of experience with TriVex? What initial concerns did you have? How did you improve your results over time? Madhavan: Experience with TriVex at our center has made us acutely aware that this technique is very different from conventional varicose vein surgery. These differences make the learning curve very crucial here. For example, complications are a real possibility unless everyone involved is fastidious about the technique. After our initial pilot study, we were concerned that postoperative pain might be a major issue. Once we were able to rectify this by refining our technique, postoperative pain was no longer a problem with our patients. There are two reasons for the improve- 4

5 ment in our results: use of a high-pressure pump for tumescent analgesia and refining the actual technique for carrying out the powered phlebectomy. Cheshire: Our experience with TriVex has generally been very good. However, it is clear to me that attention to detail in what appears to be a rather simple technique is the secret to achieving a good outcome. I believe that the use of a wide field block on secondary tumescence is essential to minimizing hematoma formation. I have learned a lot about the positioning of cannulae and believe that the principles of in-line resection and avoiding sweeping movements are key. I now also use TriVex in conjunction with other techniques such as routine hook phlebectomy and sclerotherapy, when appropriate. Marston: My concerns during my initial experience with the TriVex system were relatively simple. How extensive would bruising and hematoma formation be following surgery? Would patients experience pain or neuropathy? What about the cosmetic result of TriVex? I found the learning curve to be relatively short certainly no more than 10 to 20 cases. Some of the problems we initially encountered were with particularly large varicosities and hematoma. Our use of larger blades, a steep trendelenburg position, and second-stage Tumescence has significantly reduced this problem. In patients with more superficial varicosities and thin, friable skin, we have markedly improved our results by using short bursts of transilluminated powered phlebectomy and angling the blade away from the skin. Finally, we found that that late cosmetic results, that is, those that occur after three to six weeks of healing, were very good. In fact, the late cosmetic results with TriVex were significantly better than with manual phlebectomy. Elias: Your comments in reply to this question highlight a key point regarding new technologies. Each of you has provided a valuable mini-insight into your evaluation process and how you improve a new technology. You shared your own personal learning curve. Of course, this evaluative process can be used with any new technology. Elias: When you finally reach a level of comfort with a new minimally invasive vascular technique, is it time to rest and relax or to modify and improve it? What did you think in the case of TriVex? What have you done in the past? Cheshire: Oh, that is definitely the time to modify or improve the technique. I am still working out which sites and vein-skin types are best suited to TriVex in order to gain maximum advantage. I think that there are a number of additional techniques we must introduce to minimize bruising. As I mentioned previously, I am interested in using TriVex with other new technologies to achieve the best possible outcomes. Marston: Obviously, you can never rest after developing a new procedure unless the results are perfect and cannot be improved which is never the case. The modifications most needed with TriVex include a better tumescence system and longer blade handles to allow fewer incision sites. We also must perform randomized trials to compare TriVex to standard manual phlebectomy. This type of research is the only way to determine whether this technique is actually better than the standard technique, or just represents another option. Actually, this trial is reportedly enrolling patients at this time. Madhavan: Whenever you think you have learned all there is to know about a new technique, problems crop up. This is the most dangerous time. Surgeons can never afford to become complacent, as the challenge to continuously improve surgical techniques is what keeps us going. From a personal point of view, whenever I have gotten comfortable with a technique, that is the time I actively look for ways to make even minor modifications that can positively impact the overall outcome. At times, however, new frontiers do not consist of modifying current techniques but of radically rethinking your approach and tackling the problem from an entirely different angle. Elias: I would like to thank all of the panelists for sharing their experiences and insights. This symposium has been very beneficial. All of you have emphasized the basic fact that any procedure whether old or new is a work in progress. As vascular surgeons we are always evaluating how things are currently being done and thinking of better ways to do them. Some improvements are due to a conscious effort, some are the result of experience, and others simply grow out of the type of surgeon working in that area. For a listing of training programs log on to Steven M. Elias, MD, FACS Stephen Elias graduated from State University of New York at Buffalo Medical School and was a resident there. He completed a vascular fellowship at Englewood Hospital and Medical Center in New Jersey, where he is now director of the Center for Vein Disease. Dr. Elias has written a number of journal articles in the area of vascular surgery. Prakash Madhavan M.B.B.S., F.R.C.S.Ed. FRCS Prakash Madhaven graduated from Stanley Medical College in Madras, India, and trained in Ireland. After working in the United Kingdom, he moved back to Ireland, where he now is a consultant general and vascular surgeon at St. James s Hospital in Dublin. He has co-authored a number of journal articles and is a member of the Association of Surgeons of Great Britain and Ireland and the European Vascular Surgical Society, among other professional groups. William A. Marston, MD William Marston graduated from the University of Virginia School of Medicine. He completed a residency in general surgery and a fellowship in vascular surgery. Dr. Marston currently serves as associate professor at the University of North Carolina School of Medicine. He has written a number of journal articles and book chapters and is a member of the American Association for Vascular Surgery and American Venous Forum, among other professional affiliations. Nick Cheshire, MD. FRCS Nick Cheshire is currently a consultant in vascular surgery at St. Mary s Hospital in London. He recieved his MD from Leicester Medical School in Leicester, England. Upon graduation, Mr. Cheshire completed his residency in vascular surgery at St. Mary s Hospital. In addition to his duties at St. Mary s Hospital, Mr. Cheshire is a tutor in vascular surgery with the Royal College of Surgeons. 5

6 Changing Concepts in Varicose Vein Surgery Continued from page 1 basic questions need to be addressed and answered. As this list illustrates, there currently are more questions than answers. Possible solutions to some of these puzzling questions will be addressed in the following sections. Transillumination and identification of venous clusters 1. Can incompetence of the great saphenous vein (GSV) best be treated by using duplexguided sclerotherapy as an office-based procedure to save on cost? 2. Is it still necessary to perform flush ligation of the saphenofemoral junction? Or is it sufficient to obliterate the GSV using a venous closure method, eg, laser catheter or radiofrequency thermal heating? 3. Is there need for a technique that allows intraoperative quality control to improve surgical outcome as an alternative to injection therapy? 4. Should all patients with varicose veins accompanied by leg ulcerations be treated solely with compression therapy? Does subfascial endoscopic perforator vein surgery (SEPS) play any role in the treatment of these patients? 5. Should the deep venous system be addressed separately? Therapeutic Approaches The principles underlying successful treatment of varicose veins are fairly simple in theory. The physician must first correctly identify the site of valvular incompetence. Then, the site must be controlled using surgery or a non-surgical approach, eg, sclerotherapy. The microsurgical techniques involved in this type of surgery consist of making 1 mm incisions and utilizing special hooks (Varaday hooks, Storz, Tuttlingen FRG) to extract varicose branches. 4 These tiny incisions do not require any sutures. A GSV that is refluxing and varicose typically is stripped; however, when a duplex examination of the GSV shows reflux of the proximal segment only, without clinically visible varicose changes, it is appropriate to perform flush ligation without stripping. Limited inversion stripping is confined to an area that extends no further distally than to the medial part of the knee to avoid saphenous nerve injury and to spare intact vein segments. 5 Hook phlebectomy was introduced in 1966 to treat patients with varicose vein clusters. With this method, excision of varicose veins is accomplished through a dozen or more incisions, with satisfactory clinical and cosmetic results. However, mini-phlebectomy is dependent on pre-operative marking and essentially is a blind procedure since the surgeon is not able to see directly where the varicose veins are located. Any improvement of this technique should include providing direct vision, which would enable the surgeon to excise varicose veins more rapidly and with greater efficiency. More recently we have started using the TriVex technique of transillumination and powered phlebectomy in order to save time and reduce the number of incisions required to remove large varicose vein clusters. Powered phlebectomy enables the surgeon to localize the varicose veins and to perform resection through a minimal number of incisions. Transillumination with the TriVex cannula is useful in assessing the completeness of the procedure, thereby providing intraoperative quality control. (See Fig 1.) This technique is particularly helpful in patients with recurrent varicosities. The TriVex system vein resector is a rotating, tubular inner cannula encased in a stationary outer sheath dissector. The vein is suctioned into the cannula through a working tip and subsequently is morcellated and removed. The resector-suction device also has a second function; it evacuates any hematoma from the extracted side branches or the subcutaneous saphenous vein canal. The TriVex procedure is always combined with tumescent anesthesia, 6 which is applied with a tumescent cannula illuminator. Tumescent anesthesia consists of infusing 1000 ml of 0.9% normal saline with additions of 50 ml of 1% lidocaine and 2 ml of epinephrine. (See Figure 2.) Most venous procedures, including GSV stripping, can be performed using tumescent anesthesia Transillumination permits the surgeon to perform a more complete operation with significantly fewer residual varicose veins. Compared to hook phlebectomy, transillumination with the TriVex cannula requires fewer incisions and gives a much better cosmetic result 7. In patients with large vein clusters, transillumination can be performed more rapidly than the sometimes tedious hook phlebectomy with a saving in operating time of 20 30% 7. This timesavings is even more Operative Technique Certain procedures have traditionally been a basic part of venous surgery. The first step is flush ligation of the saphenofemoral junction, including ligation of all major tributaries, particularly the accessory saphenous veins. Second, the surgeon should microsurgically excise local varicosities. Third, limited inversion stripping of the GSV should be performed. In our institution, we have added a fourth paradigm intraoperative quality control. Figure 1. Transillumination and identification of venous clusters 6

7 important in patients with bilateral varicosities. Tumescent anesthesia is one of the most important elements in this operation. If it becomes necessary to perform GSV stripping, use of tumescent anesthesia permits the surgeon to perform the whole procedure under local anesthesia. Tumescent anesthesia is one of the most effective techniques available to avoid postoperative hematomas. In our experience this is even more effective than using a tourniquet which when the pressure drops below the systemic blood pressure can cause venous congestion and subsequently diffuse hematoma. Therefore, second-stage tumescent application is even more important than the tumescent fluid given before powered phlebectomy because it reduces and washes out hematomas. Up to 10 liters of tumescent fluid are infused in plastic surgery, eg, liposuction. In TriVex procedures, up to two liters of tumescent fluid can safely be administered in each leg without any systemic side effects. Varicose Vein Surgery Versus Sclerotherapy We conducted a prospective study in which we evaluated patient satisfaction and treatment outcome in those patients admitted for operative treatment of chronic venous insufficiency. During a 20 months period, 1000 patients were referred for varicose vein surgery. Of this group, 146 patients (14.6%) had previously undergone sclerotherapy of the proximal greater saphenous vein, the accessory saphenous vein, or other major tributaries of the saphenofemoral junction. The 117 patients (11.7%) who were admitted with varicosities recurring after surgery served as a control group, allowing a comparison between the outcomes of surgery and sclerotherapy. The patients filled out a special questionnaire that was designed to assess the type of practitioner initially seeing and treating patients with chronic venous insufficiency (CVI) and with what result. Intermediate Results of Sclerotherapy A preoperative duplex examination of the group of 146 patients who were referred for surgery after failed sclerotherapy was performed. This procedure allowed Figure 2. Transilluminator and Resection device placed opposite to each other. detection of a refluxing GSV that was only partially obliterated in combination with patent accessory saphenous veins in 113 patients (77.3%). Since the injection treatment was performed a mean of 3.2 years prior to surgery, it is justified to infer that reflux of the saphenofemoral junction was already existent when sclerotherapy was initially performed. The majority of cases (88.4%) had a median number of five sclerotherapy sessions. In the group of patients with recurrent varicosities (controls), the median interval between the first operation and the repeat procedure was 9.2 years. Reflux of the saphenofemoral junction could be detected in 37 cases (31.6%), requiring reexploration of the groin. Results of Sclerotherapy as Perceived by the Patient Analyses were performed of the patient questionnaires completed by the 146 patients with prior sclerotherapy. The majority of the patients (84.2%) complained that they had not been informed about possible side effects of sclerotherapy, alternative treatments, or the lack of durability of the procedure. In 77 cases (52.7%), the patient had been told that any kind of surgery could be detrimental. In 69 cases (47.2%), patients were not happy about the cost and the duration of the treatment. Hyperpigmentation, thrombosed veins, and/or cutaneous discoloration occurred as a side effect of sclerotherapy in 29 cases (19.8%). Most patients considered these side effects to be a cosmetically unsatisfactory result. One likely conclusion of this study is that sclerotherapy in the setting described is mostly ineffective in the long term. It cannot be considered a cost-effective therapeutic option because of the numerous treatment sessions required and the subsequent surgery needed by many patients. Improving the Surgical Approach Is it still necessary to perform flush ligation and strip the GSV? Careful ligation of all tributaries in the groin and flush ligation of the GSV has been one of the most important paradigms of venous surgery. However, no matter how carefully flush ligation was originally performed, the recurrence rate never dropped below 20 30% because of neovascularization and reconnection of the saphenofemoral junction. Hopefully, this question will be answered when the results of prospective randomized trials comparing flush ligation and stripping versus catheter-based GSV obliteration become available. It appears that severe problems associated with catheter techniques, eg, heat injury of the skin, can be avoided when tumescent anesthesia is used to perform a kind of hydrodissection to separate the vein from the skin. TriVex is a very efficient way to treat patients who have large varicose vein clusters. The cosmetic outcome is not the most important issue when comparing TriVex with state of the art microphlebectomy. The 1 mm incisions used for hook phlebectomy are not detectable postoperatively and do not even require stitching. Yet TriVex allows a drastic reduction in the number of incisions and in operating time. What may be even more important is that TriVex provides a means for intraoperative quality control in varicose vein surgery. We are confident that further studies will show that this technique efficiently reduces the recurrence rate as well as the number of remnant varicosities. 7

8 Endoscopic Perforator Surgery Patients with leg ulcerations secondary to varicose veins are still frequently treated over a long period of time with compression therapy. In a substantial number of cases, this conservative approach will result in ulcer healing. However, it is also associated with a greatly increased recurrence rate, which causes further deterioration of the quality of life of these patients. Endoscopic perforator surgery (SEPS) is a less invasive approach to the treatment of chronic venous insufficiency. SEPS represents an endoscopic approach to the Linton procedure, which required long skin incisions through subcutaneous tissue and diseased skin. Before the introduction of SEPS, subfascial ligation of perforators using multiple stab incisions or the classical Linton procedure was used to treat patients with incompetent perforating veins and chronic venous disease. One of the major drawbacks of these surgical techniques was the high incidence of wound healing problems, which resulted in a prolonged hospital stay and increased costs. Endoscopic perforator surgery was finally introduced as an alternative because this technique made it possible to ligate perforator veins by making an incision in a non-diseased skin area. SEPS is minimally invasive and has proven safety and efficacy when used in patients with ulcerated legs due to venous insufficiency. SEPS has a significantly lower complication rate than the radical Linton procedure with its substantial morbidity. To date, the only comparative study initiated in patients with active ulcers was abandoned because the complication rate in patients treated with the Linton procedure was unacceptably high. SEPS can be performed using either a dual port approach with two trocars and CO 2 insufflation or a rigid endoscope, which also permits CO 2 distension of the subfascial space. In many cases the single scope technique is more expeditious and easier to adopt, especially when combined with balloon technology. Deep Venous Reflux Controlling the sites of superficial reflux is sufficient to reduce the overload of the deep venous system in the majority of patients. However, reflux into the deep venous system and/or reflux in combination with obstruction in patients with postthrombotic syndrome can be very problematic to treat and often has unsatisfactory long-term results. Currently, clinical trials with either cryopreserved human valves or stent-mounted artificial valves have not yielded results that would justify wider application. There will remain a small cohort of patients in whom deep venous valve repair is clearly indicated. These more advanced procedures are primarily performed as an adjunctive operation after surgery to reduce superficial venous reflux. Conclusion In patients with advanced CVI and saphenofemoral reflux, sclerotherapy of the saphenous vein or one of its major tributaries does not present an alternative that is equally efficacious to a surgical approach that involves microsurgical techniques and intraoperative quality control. If symptom control and recurrence rates are the outcomes of most interest, it is important to use these endpoints as criteria for comparing conservative treatment options and modern surgical techniques. Surgery is cost effective as a radical procedure, even when using relatively expensive adjuncts, when it is offered as an outpatient operation. The time has come to subject therapeutic options for the treatment of varicose veins to the same rigorous economic assessments that other health care sectors are already receiving namely, the comparative assessment of costs and benefits, including length of efficacy and recurrence rate. 8.9 Varicose vein surgery can provide excellent functional and cosmetic results when preoperative venous duplex tests and new microsurgical techniques are employed. The surgical approach to treating varicose veins is significantly more durable and cost effective compared to any kind of injection therapy. References: 1. Messina LM, Tierney LM, Jr. Blood vessels & lymphatics. In: Tierney LM, Jr., McPhee SJ, Papadakis MA, eds. Current Medical Diagnosis & Treatment New York:Lange Medical Books/McGraw-Hill, 2002: Dodd H, Cockett FB. Management of varicose veins. In: The Pathology and Surgery of the Veins of the Lower Limb, 2nd edition. Edinburgh: Churchill Livingstone, 1976: Hobbs JT. The management of varicose veins. Surg Annu 1980; 12: Varaday Z. Microsurgical venous extraction. Vasomed 1990; 3: Wilson S, Prye S, Scott R. Inversion stripping of the long saphenous vein. Phlebology 1997; 12: Hanke CW, Bernstein G, Bullock S. Safety of Tumescent liposuction in 15,336 patients. Dermatol Surg 1995; 21: Cheshire N, Elias SM, Keagy B, et al. Powered phlebectomy (TriVex ) in treatment of varicose veins. Annals of Vascular Surgery [ journals/10016/contents/01/0100/paper/body.html] Accessed 7/ JE Brazier, Johnson AG. Economics of surgery. Lancet 2001; 358: Bishop CC, Fronek HS, Fronek A, et al. Real-time color duplex scanning after sclerotherapy of the greater saphenous vein. J Vasc Surg 1991; 14: ; discussion Ralf Kolvenbach MD, PhD Dr. Kolvenbach attended medical school at the University of Duesseldorf and did a general surgery residency before completing residencies in cardiovascular and in cardiovascular/thoracic surgery in the United States. He currently is director of the Venous Clinic and Vascular Therapy Center at Duesseldorf. Dr. Kolvenbach is a Fellow of the German Board of Vascular Surgery and the German Board of Phlebology, among other affiliations. Editorial Consultants Steve Elias MD FACS (USA) Kenneth E. Harper MD (USA) Olivier Lesceu MD (Belgium) William A, Marston MD (USA) Edwin Gonzalez Navedo MD FACS (Puerto Rico) Phillipe H.R. Nicolini MD (France) Venous Diseases: An International Dialogue is a serial publication distributed free-of-charge to health professionals. Venous Diseases: An International Dialogue is published by Saxe Healthcare Communications and is funded through an education grant from Smith & Nephew. Our objective is to provide clinicians, surgeons and researchers with topical information on cutting-edge diagnostic techniques, minimally invasive procedures, practice-building strategies, and practical approaches to training in the area of venous diseases. 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