Stefano Ricci
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Abstract The objective of the present prospective multicenter study was to analyze short-term outcomes after single phlebectomies of a large incompetent tributary joining the GSV at thigh level in patients who also have GSV incompetence and to determine predictors for restoration of great saphenous vein (GSV) competence. Recruitment of 100 patients started in April 2010 and ended in March 2012. Consecutive adult patients with symptomatic primary GSV incompetence and a clinically visible incompetent tributary of the GSV at the medial thigh (with or without extension below the knee) were eligible to participate. The saphenofemoral junction (SFJ), the GSV in the thigh above and below the junction of the tributary, the tributary itself, and the GSV below the knee were studied in particular. Valvular function was studied by manual calf compression; the Valsalva maneuver was performed to assess reflux at the terminal valve of the SFJ. Two diameter measurements were performed, respectively, 2 cm above and below the junction of the refluxing tributary. The reflux elimination test was performed by digital compression of the refluxing tributary in the thigh to test whether this could modify GSV reflux. Phlebectomy was performed by use of local anesthesia with lidocaine 1%. Patients were invited for follow-up 3 months after the procedure: if patients presented with persisting symptomatic GSV incompetence, additional treatment was proposed by either endovenous thermal ablation or ultrasound-guided foam sclerotherapy. Patients without GSV incompetence or without symptoms were scheduled for a follow-up visit 12 months after the initial procedure. The primary outcome was absence of reflux in the entire GSV, measured by DUS evaluation after 1 year. Secondary outcome measures were C class of the Clinical, Etiologic, Anatomic, and Pathologic (CEAP) classification, VCSS (range, 1-10), and AVVQ score (range, 1-100). Multivariable logistic regression including all clinically relevant variables following a backward variable elimination process was used to determine predictors for success. In total, 94 patients were analyzed, 65 women and 29 men; 55.3% patients were classified as C2, 35.1% as C3, and 9.6% as C4. The mean GSV diameter was 0.55 cm (SD, 0.15; range, 0.28-0.95 cm) above the tributary and 0.36 cm (SD, 0.16) below the tributary. Half of the patients had terminal valve reflux at the SFJ. In approximately half of the patients, reflux was present only in the most proximal segment; the rest also had reflux more distally. A significant relation between reflux at the terminal valve and GSV diameter was found. In patients without terminal valve reflux, GSV diameter was more often <5 mm; a lower C class and diameter <5 mm were significantly related to success. In 47 patients (50%), reflux disappeared completely after 12 months. In 15 patients (16%), phlebectomy resulted in complete relief of complaints despite persisting GSV reflux; these patients did not undergo additional treatment. The remaining 32 patients had persisting symptoms and underwent additional GSV ablation. The mean diameter of the GSV above the tributary decreased significantly after 3 and 12 months from 0.55 cm to 0.36 cm and 0.39 cm. The C class decreased significantly after treatment while VCSS and AVVQ score improved in all patients (independent of hemodynamic effect) after treatment. Reflux was more often abolished when the following parameters at baseline were present: C2; short (<10 cm) refluxing segment; reflux in only one GSV segment; smaller diameters of GSV and tributary; positive result of the reflux elimination test; and low VCSS and AVVQ score. Patients with a positive reflux elimination test result have a more than 65% chance of success. Even if saphenous reflux persists, phlebectomies probably reduce the total refluxing volume, explaining the clinical and hemodynamic improvements. Consequently, treatment of varicose vein patients should be individualized because every patient is different in anatomy, hemodynamic, clinical presentation, and impact of varicose veins on quality of life and symptoms. The predictors for success found in the present study may orient the physician toward a less invasive approach, which may consist of single phlebectomies in properly selected patients. Even in the presence of saphenous reflux, phlebectomies may be the first-line treatment, avoiding needless saphenous ablation. |
Comment by Stefano Ricci
This interesting paper underlines concepts that were introduced more than 20 years ago by conservative venous treatments fans, like Franceschi, Cappelli, Zamboni, Escribano, and other more, correctly cited in the reference section, but not underlined in the discussion. Even Muller’s philosophy could be recalled: the sentence Even in the presence of saphenous reflux, phlebectomies may be the first-line treatment, avoiding needless saphenous ablation could have been one of his own.
The study is accurate, complete and well organized, however some aspects deserve a more detailed analysis:
i) The reflux elimination test (RET), correctly introduced as a possible predictor test, was described by Zamboni as a method for differentiating shunts (shunt I + II = negative test; shunt III positive test). In fact when the RET is positive, the reflux on the GSV stops when the tributary connected to the re-entry perforator is compressed, not allowing the flow to re-enter in the deep vessels. If, at the opposite, a re-entry perforator is centered also on the GSV more distally (or in a more distal tributary), the RET will be negative, as the higher tributary compression do not impede the re-entry flow. As a consequence, every phlebectomy performed when the test is positive will make the reflux disappear; with a negative test, the reflux will continue through the untouched circuit although the reflux will decrease (with clinical improvement). In these patients the GSV incompetence involves the vein distally to the tributary showing a larger caliber.
This said, the reflux disappearance in RET positive subject is not due to a competence achievement (valves restoration), but to the interruption of the hydraulic circuit (blockage of re-entry) so that Doppler cannot trace any retrograde flow, the GSV remaining virtually incompetent; as soon as a new vein begin to develop (recur) where the tributary was interrupted, the reflux appears again, as a flow now is possible again. Curiously, RET+ patients were 61 while no-reflux + reflux-without-symptoms were 62 confirming what said.
This explanation, that gives a meaning to the paper’s results, should have been analyzed and suggested to the lecturer.
ii) Another point of interest is related to terminal valve competence –52%/incompetence 48%. Authors report that GSV caliber in competence cases was more often (?) <5 mm, and >5 mm in incompetent junctions, and they add that success was related to smaller calibers. However, because of statistical non significance, reflux at the terminal valve was removed from the model, apparently a contradiction. This decision is not clear and could be explained. At the opposite, correlation between terminal valve competence, RET +, and reflux disappearance would have been of great interest.
iii) Finally, it is not reported how tributaries phlebectomy was managed: only thigh varices were avulsed? What about other limb varices? When the reflux re-entered the GSV stem, was the case still included?
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