The identification of the “top” or “best” articles published in Phlebology in the past year is an impossible task. In this exponentially growing field, there are countless international, studies published and many which deserve mention. Although there has been an emphasis on evidence-based medicine, many smaller studies have been done in phlebology as an early attempt to answer some of the many questions in this rapidly changing field. But what is the definition of a good paper? We appreciate clinical studies with strong study design, prospective, randomized, long term follow up, and with large numbers of subjects. In addition, there are those with interesting new ideas, pertinent questions, unique case studies, and practical technical papers. In the final analysis, however, one’s own subjectivity and individual interests define what is “good.” I decided it was best to provide a list of articles which I found could be most valuable to those clinicians who dedicate themselves to the treatment of venous disease, and those which start to answer some of the more pertinent clinical questions in Phlebology. We tried to include articles from different sources, and varied topics to make things interesting.
Paper #1: What is the effect of treatment on Deep Venous Insufficiency?
Marston, William, Wells, B, Mendes, R, Berndt, D, Weiner, M, Keagy, B, The importance of deep venous reflux velocity as a determinant of outcome in patients with combined superficial and deep venous reflux treated with endovenous saphenous ablation, J Vasc Surg Aug 2008, 48(2):400-406.
Summary: This was a retrospective review and prospectively collected case series of 75 limbs, all of which were found to have symptomatic venous disease, and both deep and superficial venous insufficiency by duplex examination. The authors examined patients with duplex, APG (VFI, Venous Filling Index), and VCSS (Venous Clinical Severity Score) before after treatment of the superficial reflux with endovenous laser ablation.
The authors introduced a new, easily obtained duplex measurement which they called MRV (Maximal Reflux Velocity) which is measured by looking at the tracing and measuring the velocity at a point 0.5 seconds after the cuff release (after the “normal” valve closure time.) If this value was <10 cm/sec in the deep vein system, this group was considered the “low” MRV group. Conversely, if the MRV was >10, it was the “high” velocity group. They analyzed the data for all patients before, at 6 weeks following the ablations, then at 6 monthly intervals, with a median follow up time of 13.1 months.
They noted an inverse correlation with the MRV and the degree of improvement in the VFI and VCSS after ablation. In other words, those with lower MRV pre-operatively had a better response to superficial ablation; whereas, those with higher deep vein reflux velocities pre-operatively had less improvement following treatment of the superficial veins. All patients showed some clinical improvement, yet those with more extensive reflux and higher MRV’s did not improve as significantly as defined by the above parameters. Those with only common femoral vein reflux appeared to do the best. Almost all patients with isolated CFV reflux noted excellent resolution of their symptoms and follow up parameters Furthermore, the value of the MRV did not affect their outcomes.
Commentary: There has been some controversy as to the relevance of deep reflux in the setting of superficial venous disease, and there have been inconsistent results with regard to the outcomes after treatment of the superficial venous insufficiency in those patients with concurrent deep venous reflux. Approximately 25% of patients with advanced venous disease have concurrent deep and superficial venous reflux.1 This paper begins to address the question of who might benefit from the treatment of superficial vein reflux.
Those with higher deep venous reflux velocities might be better considered for a more aggressive approach with more emphasis on compression therapy, and perhaps even deep venous valvular reconstruction following unsuccessful superficial venous vein ablation. Any high risk patients with deep and superfi cial reflux, and with high MRV’s, might consider deferring treatment of the superficial system. With the higher MRV’s, there appears to be less benefit. Obviously, larger subject numbers and longer follow-up are needed to make definitive conclusions. In addition, one needs to evaluate the effect of outflow obstruction and/ or perforator vein incompetence on the MRV values.
Many patients have some element of both deep and superficial vein reflux, and many clinicians have wondered if it was worth it to proceed with treatment of the superficial venous system in the presence of deep insufficiency. With the information from these papers, one might be more likely to proceed with treatment of the superficial reflux even in the presence of deep venous insufficiency. This study helps up to understand another variable that may help council patients with deep and superficial reflux.
Refs: 1 Labropolous, N, et al. Prevalence of deep venous reflux in patients with primary superficial vein incompetence. J Vasc Surg 2000;32:663-8.
Knipp, BS, Blackburn, SA, Bloom, JR, Fellows, E, Laforge, W, Pfeifer, JR, Williams, DM, Wakefield, TW, and Michigan Study Group. Endovenous laser ablation: Venous outcomes and thrombotic complications are independent of the presence of deep venous insufficiency, J Vasc Surg, 2008 Sept 30
Summary: There were 443 cases of EVL on the GSV. This group was divided into those who had deep venous insufficiency (DVI) prior to ablation, and those who did not. Endpoints were VCSS and venous occlusion rates. The patients were evaluated up to 12 months post ablation.
The changes in VCSS and the occlusion rates were unchanged in the patients with deep venous insufficiency, and those without. There were no differences in the DVT/ thrombus extension rate or superficial phlebitis between the two groups. Their results showed excellent occlusion rates at 1 year (95%), and the VCSS improved significantly over each of the data points for both groups. The rate of vessel occlusion was unaffected by performance of AP, presence of DVI, gender or age. Overall, successful ablation and clinical improvement in VCSS seemed to be independent of the finding of DVI in patients.
Paper #2: What’s new in Endovenous Thermal Ablation?
Proebestle, TM, Vago, B, Aim, J, Gockeritz, O, Lebard, C, Pichot, O, Treatment of incompetent great saphenous vein by endovenous radio frequency powered segmental thermal ablation: first clinical experience, J Vasc Surg, 2008, 47(1): 151-156.
Summary: This was a prospective, non-randomized clinical trial done to evaluate the safety, feasibility, and early clinical outcomes of the new RF segmental catheter for thermal ablation of the GSV. They included 252 GSV’s treated with diameters ranging from 2-18 mm diameter, and with an average treatment length of 36.7 +/- 10.8 cm, and average treatment time of 16.4 minutes. Seventy-one percent (71%) of limbs had concomitant phlebectomy, 14% had simultaneous Sclerotherapy of tributaries. Follow up consisted of clinical assessment and duplex scans at 3 days, 3 months, and 6 months. Occlusion rates and Venous Clinical Severity Score (VCSS) were measured. Complications were recorded. Occlusion rates were high at each data point and VCSS improved significantly, especially with regard to the degree of edema. Of note, the patients were wearing compression post operatively. Complications were rare, and minor: 3.2% paresthesias, 0.1% phlebitis, 6.4% ecchymosis, and no DVT. The study helped to define the appropriate LEED (Linear endovenous energy density), and used an average of 116 J/cm in the proximal extent (by performing a double pass for the first proximal segment), followed by 68 J/cm more distally. The closure rate was 99.6% at 3 days up to 6 months, and the veins appropriately decreased in diameter over the 6 months follow up further demonstrating the durability of the vein closure. The temperature is higher at 120° C, and it is delivered over a 7 cm segment thus allowing for a more controlled heating and perhaps lower incidence of perforation, and pull back variability or skip areas as were seen with the older catheter.
Commentary: This paper was the first report using the new segmental RF catheter. Although it lacked a control group, it did demonstrate safety and efficacy of this new catheter. One would certainly like to see the longer follow-up on more of the patients. A comparative trial would be an interesting study. This study is just the beginning of the story for the newer RF catheter, and many questions remain to be answered. The use of this catheter in larger veins, shorter segment veins, and other more difficult clinical scenarios must also be studied. Dr. Proebstle from Germany has presented a simple, yet helpful paper which helps clinicians understand and see some preliminary results for this newer technology.
Other good refs: Elmore, FA, and Lackey, D, Effectiveness of endovenous laser treatment in eliminating superficial venous reflux, Phlebology 2008;23:21-31.
This was a retrospective review of a single center’s 516 EVL cases, describing the protocols, examining the outcomes with closure rates, QOL issues, need for subsequent treatments, and complications. The later cases were done at a higher energy level which conferred a higher closure rate. They also examined, and helped to define a safe and effective LEED that could be used to close veins successfully without excessive side effects.
Paper #3: What’s new in Sclerotherapy? Foam vs. Liquid?
Ouvry, P, Allaert, F, Desnos, P., Hamel-Desnos, C, Efficacy of Polidocanol Foam versus Liquid in Sclerotherapy of the Great Saphenous Vein: A Multicentre Randomised Controlled Trial with a 2-year Follow-up, Eur J Vasc Surg (2008);36:366-370
Summary: This randomized trial of foam vs. liquid Sclerotherapy of the GSV was done using a single injection and a single treatment session with a 2 year follow up on almost all of the patients. Endpoints after injection were immediate vessel spasm, elimination of reflux, degree of closure as measured by duplex, length of vessel occlusion, and side effects. Volumes injected were low, and there were no patients re-treated during the study period. Ninety of 95 patients followed up to 2 years, and those who did not follow up were in the foam group (which was more successful in closing down the veins in the first treatment.) These 5 unknown cases were counted as “failures” in the final analysis. There were no cases of symptoms related to embolism of the sclerosant in any of the 95 cases, and the incidence of side effects was low and similar in both groups.
Commentary: This paper is similar to others (Rabe, et al and Yamaki, et al) which showed clinically significant improvement after treatment with foam rather than liquid sclerosant. We, as clinicians, have to take these data into account, but one is also concerned with reports of significant embolic events to the brain or the effect of foam on the pulmonary microvasculature. All three of the papers mentioned above reported no embolic complications, although they excluded patients with PFO or history of migraine, and they all used small volumes of sclerosant (<5 cc per treatment.) We certainly need more study of the effects of composition, volume, concentration and positioning of the patient. A study by Hill et al() looked at cardiac echo images while performing foam Sclerotherapy while the patient was in different positions. This was a small study, yet showed nicely that proximal compression at the groin during injection led to a delayed concentrated bolus of foam in the heart when the pressure was released. They concluded that ultrasound guided sclerotherapy was least likely to produce major embolization when performed with the legs elevated, and without proximal compression applied. These small randomized studies with short and mid-term follow up help us to begin to understand the optimal approach to Sclerotherapy.
Of course, endothermal ablation of the GSV has consistently shown better clinical success in the saphenous system, but for those patients who would like to avoid the discomfort of tumescent anesthesia, or those clinicians who do not have the facilities to perform RF or Laser ablation, or when the reimbursement is an issue, the cost of Sclerotherapy can certainly be more desirable despite the need for further treatments. This mid-term 2 year follow up was encouraging to help understand the durability of Sclerotherapy.
Refs: Hill, D, Hamilton, R, Fung, T, Assessment of techniques to reduce sclerosant foam migration during ultrasound-guided Sclerotherapy of the great saphenous vein, J Vasc Surg October 2008;48(4):934-939
Rabe, E, Otto, J, Schliephake, D, Pannier, F, Efficacy and safety of great saphenous vein Sclerotherapy using standardized polidocanol foam (ESAF): a randomized controlled multicenter clinical trial, Eur J Vasc Endovasc Surg 2008 Feb;35(2):238-45
Yamaki, T, Motohiro, N, Hiyoyuki, S, Takeuchi, M, Soejima, K, and Kono, T, Prospective randomized efficacy of ultrasound guided foam Sclerotherapy compared with ultrasound-guided liquid Sclerotherapy in the treatment of symptomatic venous malformations, Journal Vasc Surg March 2008;47(3):578-584
Paper #4: What happens to Perforator Veins? When should they be treated?
Parks, T, Lamka, C, Nordestgaard, A, Changes in Perforating Vein Reflux after Saphenous Vein Ablation, The Journal for Vascular Ultrasound 2008;32(3):141-144
This small, but well done prospective duplex study of perforator veins helps to answer the question of what happens to incompetent perforator veins after treatment of saphenous vein reflux. 100 patients were followed after saphenous vein ablation. 169 perforators were initially identified as incompetent; they were followed and documented carefully before treatment, and evaluated for size and competency at 3 days following saphenous vein ablation. They found that 54% of the incompetent perforators became competent, 12.5% were occluded, and 33.1% were unchanged. Pre-operative perforator diameter was the determining factor in the reversal of reflux. The number of phlebectomy/stab avulsions performed during the EVLT procedure had no significant effect on the status of the perforators post operatively.
Commentary: This question of indication and timing of interruption of incompetent perforator veins is a common one in Phlebology practice. Many patients with advanced CEAP classification have multilevel disease, and the clinician needs to determine how to address the saphenous insufficiency as well as whether or not to intervene simultaneously with the incompetent perforator veins. Ambulatory venous hypertension leads to progressive changes of venous insufficiency. Lowering the pressure by treating the superficial reflux is usually helpful, but certain patients seem to respond better than others. This study demonstrates the immediate effect on the incompetent perforators after endovenous laser ablation of the GSV. The 33% of IP’s that remained incompetent had larger diameters ( mm). Further study is obviously needed with longer term follow up of not only the duplex changes, but also the clinical endpoints of ulcer healing and recurrence, etc. An excellent review of this topic was published by O’Donnell, who looked at all the treatment modalities for perforator treatments. He also found evidence suggesting that the treatment of the GSV alone directly affects the competence of the perforating veins. He discussed level 1A evidence showing the benefit of treatment of the GSV for lowering ulcer recurrence, yet there is only level 2B evidence for treating incompetent perforators. We certainly need more careful study of perforato veins and definitions of how to measure size and incompetence. In addition, protocols for treatment and timing must be established.
Refs: Odonnell, T, The present status of surgery of the superficial venous system in the management of venous ulcer and the evidence for the role of perforator interruption, J Vasc Surg 2008;48(4):1044-52.
Paper #5: How and when should we worry about refluxing Pelvic Veins? How to diagnose pelvic venous congestion syndrome?
Asciutto, G, Mumme, A, Marpe, B, Koster, O, Asciotto, KC, Geier, B, MR Venography in the Detection of Pelvic Venous Congestion, Eur J Vasc Endovasc Surg 20008;36:491-496.
Pelvic venous congestion syndrome has been a highly under recognized and overlooked diagnosis for many years. Finally, clinicians are asking the proper questions and finding out why the venous anatomy in the lower extremity is not responding to standard treatments. Patients with thigh, labial, buttock varicosities often have a source of reflux above the inguinal ligament. Their symptoms can include increased abdominal pressure, congestive dysmenorrhoea, dyspareunia, postcoital aching, and even urinary difficulty when they present to their gynecologist or primary care provider. In the setting of lower extremity venous disease, one should suspect pelvic venous congestion. Other patients will present to the phlebologist complaining only about their leg symptoms. A high index of suspicion, an accurate history and careful physical exam can lead one to suspect pelvic venous insufficiency. Until recently, there has been logistical difficulty in making this diagnosis without performing an invasive venogram. In addition, there have been concerns with ionizing radiation and dye which make this a less desirable test.
This was a small study of 23 patients who each had MRV, duplex and venography. MRV has now been directly compared with the other modalities. The MR protocols were established, and the results validated using standard phlebography as the gold standard in making this diagnosis. The discrepancies between MRV and phlebography revealed that MRV underestimated the amount of pelvic congestion, and especially failed to appreciate the degree of dilatation in the hypogastric and pelvic plexis veins. MRV gave a high sensitivity for detecting the presence of congestion in ovarian veins of 88%, but there was a slightly lower specificity of 67%. Although the MRV was not as effective in making the diagnosis in the early stages of disease, there were no changes in suggested treatment recommendations when utilizing the two tests (examiners were blinded when analyzing the results). MRV results were satisfactory for use as a lower risk screening tool in patients with suspected pelvic congestion symptoms. Further study is certainly recommended.
Other refs: Tropeano, G, Di Stasi, C, Amoroso, S, Cina, A, Scambia, G, Ovarian vein incompetence: a potential cause of chronic pelvic pain in women, Eur J Obstet Gynecol Reprod Biol, Aug 2008;139(2):215-221