Journal of Vascular Surgery
Volume 41, Issue 1 , Pages 130-135, January 2005

Extension of saphenous thrombus into the femoral vein: A potential complication of new endovenous ablation techniques

Division of Vascular Surgery, Mayo Clinic

Received 2 September 2004; accepted 30 October 2004.

Article Outline

Endovenous techniques such as radiofrequency ablation (RFA) and endovenous laser therapy (ELT) have emerged as percutaneous minimally invasive procedures for ablation of incompetent great saphenous veins in patients with varicosity and venous insufficiency. Early reports showed safety and efficacy of both techniques, with excellent technical success rates and few major complications, such as deep vein thrombosis or pulmonary embolism. During our initial experience with ELT in 56 limbs of 41 patients, 39 underwent postoperative duplex scanning. We encountered three cases (7.7%) with thrombus extension into the common femoral vein. All three patients were anticoagulated, and a temporary inferior vena cava filter was placed in one. All remained asymptomatic. The thrombus resolved by 1 month in all three patients. Review of the literature revealed that the incidence of thrombus extension into the common femoral vein or deep vein thrombosis in published clinical series is 0.3% after ELT and 2.1% after RFA. This possibility warrants routine postoperative duplex scanning, more alertness during these procedures, and patient education on this possible complication.

 

Until recently, high ligation and surgical stripping of the great saphenous vein (GSV), usually from the groin to the knee, has been the treatment of choice for GSV incompetence associated with varicose veins and chronic venous insufficiency. In recent years, percutaneous minimally invasive endovenous techniques such as radiofrequency ablation (RFA) (Closure procedure; VNUS Medical Technologies Inc, San Jose, Calif) and endovenous laser therapy (ELT) have emerged and are used with increasing frequency for ablation of incompetent GSV. Early reports have claimed safety and efficacy of both procedures, with initial technical success in more than 95% of patients. Short-term clinical benefit with sustained occlusion of the GSV and freedom from reflux at 2 years has been reported in 95% to 97% of patients. These procedures have already replaced standard surgical stripping as the therapy of choice for many patients undergoing GSV ablation. Major complications such as deep vein thrombosis (DVT) and pulmonary embolism (PE) have been reported to be relatively rare with these techniques.1

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Case reports 

Since the introduction of ELT, 56 limbs in 41 patients (76% female; age, 51.6 ± 13 years [mean ± SD]) were treated with this technique at our institution between July 14, 2003, and February 3, 2004. Indications were symptomatic lower extremity varicose veins (class 2-4) in 54 (96%) limbs and advanced chronic venous insufficiency (class 5-6) in 2 (4%) limbs. Etiology was primary in 53 limbs (95%) and secondary in 3 limbs (5%). GSV ELT was combined with surgical varicectomy (n = 54; 96%), stripping of the small saphenous vein (n = 2; 4%), and additional ELT of an accessory GSV in one limb. The operations were performed under general or spinal anesthesia supplemented with local tumescent anesthesia. The 810-nm diode laser was used, and the GSV from just distal to the inferior epigastric vein to the knee was treated. All 56 procedures were successfully completed. Forty-five (80%) limbs in 32 patients have been followed up clinically; duplex ultrasonography (DUS) was performed 1 week after surgery in 39 limbs. None of the followed limbs had clinical evidence of DVT, and no patient presented with PE.

In 3 (7.7%) of the 39 limbs imaged after surgery, we encountered a thrombus in the proximal GSV extending through the saphenofemoral junction (SFJ) to involve the common femoral vein (CFV). All three patients had primary varicose veins and were treated with GSV ELT and stab avulsion of branch varicosities. The length of GSV treated and the energy applied in each case are presented in Table I. Analyzing the relationship between case sequence and thrombus extension, we found that the 3 cases were No. 36 and 41 for one surgeon who performed 43 cases and No. 4 for a second surgeon who performed 12 cases. A third surgeon with one case did not have complications. Overall, they were cases 19, 48, and 54 of our cases.

Table I. Length of great saphenous vein (GSV) treated with endovenous laser therapy and the amount of energy applied in cases complicated by extension of thrombus into the common femoral vein
Case No.Length of GSV treated (cm)Laser energy (J/cm)Laser energy (J/s)Total laser energy (J)
13050171500
23050171500
33256191800

Case 1 

A 60-year-old woman received ELT treatment of the right GSV. At the routine 1-week follow-up, DUS showed a small knuckle of thrombus protruding into the CFV at the SFJ, reducing the lumen of the CFV by approximately 30% (Fig 1, A). Anticoagulation with low-molecular-weight heparin and warfarin was started. The patient remained asymptomatic, and repeat DUS in 1 week showed no change, but follow-up DUS at 3 months showed complete resolution (Fig 1, B).

  • View full-size image.
  • Fig 1. 

    A, One week after treatment, thrombus (arrowhead) appears to protrude from the great saphenous vein (GSV) into the common femoral vein (CFV). B, Three months later, the thrombus is no longer visible.

Case 2 

A 51-year-old woman was treated with ELT of the left GSV. One week later routine follow-up, DUS revealed thrombus protruding into the CFV for 2 cm above the SFJ (Fig 2, A). She was started on low-molecular-weight heparin and warfarin. One week later, interval resolution of the CFV thrombus was noted, and anticoagulation was continued for three more weeks (Fig 2, B). She remained asymptomatic.

  • View full-size image.
  • Fig 2. 

    A, Axial scan of the inguinal region showing the common femoral vein (CFV) and common femoral artery (CFA). In the left picture, the vein is partially filled by echogenic material (arrowhead). In the right picture, maximum compression with the probe was not able to produce vein collapse. B, One week later, as shown in the left picture, there was no filling defect in the vein, which collapsed (arrowhead in the right picture) as the probe compressed the inguinal region.

Case 3 

A 75-year-old woman was treated with left GSV ELT. On routine DUS at 1 week, there was a thrombus at the left SFJ, which extended into the CFV and partially obstructed the lumen for 1 to 1.5 cm. The thrombus appeared to be attached to the SFJ but not to the wall of the CFV (Fig 3, A). She was anticoagulated, and a temporary inferior vena cava filter was placed. Two weeks later, DUS confirmed complete resolution of the CFV thrombus; therefore, the filter was removed (Fig 3, B). No thrombus was identified in the filter. She remained asymptomatic, completed 3 months of Coumadin treatment, and was lost to further follow-up.

  • View full-size image.
  • Fig 3. 

    A, Longitudinal scan of the saphenofemoral junction showing the presence of thrombus in the common femoral vein (CFV) (arrows). B, Two weeks later, there was no color-filling defect in the CFV. The great saphenous vein (GSV) appears to be regularly occluded up to the superficial epigastric vein.

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Discussion 

DVT has been rarely reported after surgical treatment of lower extremity varicosity; therefore, DVT prophylaxis routinely has been limited to early mobilization and compressive stockings. Subcutaneous heparin has been used only for high-risk patients.2, 3 The surgical technique of GSV stripping includes its flush ligation with the CFV to avoid a cul-de-sac providing a nidus for proximal thrombus propagation. Although flush ligation can easily be accomplished with an open technique, the concept is compromised during endovenous therapy. The potential for thrombus extension is therefore real, because most techniques recommend leaving the upper 1 or 2 cm of the GSV open to avoid occlusion of the groin collaterals and to maintain patency of the SFJ. Only very few investigators suggest flush occlusion of the saphenous vein with the femoral vein during these procedures (R. J. Min, Cornell University, New York, personal communication, 2003).

The immediate fate of the lumen of the GSV after endovenous therapy is unclear. Min et al4 suggested that swelling of the injured venous wall obliterates the lumen after ELT. Others, however, found that GSV occlusion is a thrombotic process associated with an increase in the level of circulating d-dimer.5 Explanation for this controversy may be related to the differences in wavelength (940- vs 810-nm diode laser) and the amount of laser energy applied in these studies. Intuitively, acute thrombosis of the GSV could easily predispose for femoral DVT by propagation through the SFJ.

Despite these concerns, Min et al,4 who reported the largest series on ELT, from Cornell University, encountered no DVT in 499 limbs. Only one DVT was found in the literature among studies reporting on ELT of GSV insufficiency (Table II).4, 6, 7, 8, 9, 10, 11, 12When we looked on the Food and Drug Administration Web site for adverse reactions and searched for “Dornier MedTech” and “Diomed,” we were able to find only one case in which a small nonocclusive thrombus was observed to be partially in the femoral vein after ELT with the Diomed device (Diomed Inc, Andover, Mass).13 No reports were found for Dornier (Dornier MedTech America, Kennesaw, Ga).

Table II. Thromboembolic complications reported in clinical series of endovenous laser therapy
First author, yearWavelength of laser (nm)No. Limbs/No. PatientsLimbs followed up with DUSTiming of DUS follow-upDVTPE
Navarro,6 200181040/33401 and 7 d00
Gerard,7 200298020/20203 and 8 d00
Chang,8 20021064252/149252Not reported00
Min,4 2003810504/4234991 wk00
Proebstle,9 2003940109/851041 and 8 d0*0*
Oh,10 200398015/12151 wk00
Perkowski,11 2004940203/1652032 wk00
Timperman,12 2004810-940111/871111 wk10
Mayo Clinic, 200481056/41391 wk30

Articles that seemed to report on the same series of patients were excluded.

DUS, Duplex ultrasonography; DVT, deep vein thrombosis; PE, pulmonary embolism.

* Patients received prophylactic postoperative low-molecular-weight heparin.

Differences in finding thrombus extension after ELT, in our experiences and those reported by Min et al,4 can be explained by the technique we used. We prefer to perform ELT under general, spinal, or epidural anesthesia supplemented by tumescent local anesthesia, and we always combine saphenous ablation with stab phlebectomy. The Cornell group uses only tumescent local anesthesia for ELT and applies delayed sclerotherapy during follow-up to eliminate persistent varicosities.4, 14 Both general anesthesia and concomitant varicectomy can increase the period of immobilization; however, historically they have not resulted in such high rates of DVT after stripping of the GSV.2, 3 The amount of laser energy delivered and the size and distension of the vein with blood may influence the relative extent of destruction of the vein wall. The number of patients treated in this early phase of our experience is too small to assess all of these variables. It is also difficult to directly correlate our higher thrombus extension rate with a learning curve, because these events were sporadic during our early experience. However, the high rate of DVT in this small series suggests that the exemplary results of pioneers in ELT technology may not be easily reproducible.

Currently, there is no agreement regarding whether the first 1 to 2 cm of the GSV should be treated during endovenous laser ablation. We start GSV ablation at 1 cm distal to the confluence of the inferior epigastric vein and the GSV. Regardless of the distance considered appropriate for the proximal end point of treatment, ultrasonographic visualization of the SFJ can never be compromised. This, in our experience, permits continued patency of the SFJ, and flow from the inferior epigastric vein prevents extension of the saphenous thrombus. In addition, leg elevation during treatment decreases the blood in the saphenous vein and aids in minimizing the thrombus load in the occluded saphenous vein.

The VNUS Closure procedure is associated with a presumably higher incidence of thromboembolic complications (Table III). Twenty-one cases of DVT and 2 of PE have been reported in 11 previous articles.15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25 A recent series of 66 patients treated with VNUS Closure reported a 16% incidence of DVT.25 All but one were described as thrombus extension into the CFV. No association of the DVT episodes with the type of anesthesia, postoperative mobilization, age, sex, or associated vein procedures was found.

Table III. Thromboembolic complications reported in clinical series with radiofrequency ablation of the great saphenous vein (VNUS Closure procedure)
First author, yearNo. Limbs/No. PatientsLimbs followed up with DUSTiming of DUS follow-upDVTPE
Chandler,15 2000301/272*223Not reported31
Goldman,16 200250/47416 mo00
Komenaka,17 200229Not reportedNot reported20
Fassiadis,18 2002127/79991 wk00
Merchant,19 2002318/2862861 wk31
Rautio,20 200230/27301 wk00
Sybrandy,21 200226/26263 wk00
Weiss,22 2002140/1201401 wk00
Lurie,23 200344/44443 and 7 d00
Wagner,24 200428/24283 to 5 d10
Hingorani,25 200473/66732 to 30 d120
Mayo Clinic, 2004†51/39181 wk00

Articles that seemed to report on the same series of patients were excluded.

DUS, Duplex ultrasonography; DVT, deep vein thrombosis; PE, pulmonary embolism.

* Including eight small saphenous veins and one accessory saphenous vein.

† Unpublished data.

Searching the Food and Drug Administration Web site for “VNUS” and “Closure,” we found reports of 24 DVT episodes and 3 PE episodes.26 Some of these reports, however, may refer to the same patients, thus making it difficult to calculate the absolute number of thrombotic events. In many series of RFA, the postoperative duplex follow-up scanning is incomplete; therefore, the exact incidence of asymptomatic DVT is unknown. With these limitations in mind, we estimate that the cumulative incidence of DVT and PE after the VNUS Closure procedure is 2.1% and 0.2%, respectively (Table III). Expert authors, however, report lower incidences: in a cumulative series from Merchant et al,1 there were 5 episodes of DVT among 1150 procedures (0.4%), with no PE.

The incidence of DVT after GSV stripping is not well known. Historically, Lofgren et al27 reported 16 cases of suspected PE among more than 4000 operations for varicose veins at the Mayo Clinic. In a more recent study, 3 (0.6%) symptomatic DVT cases were reported after 544 procedures.28 Surprisingly, a prospective study with ultrasonography follow-up showed 20 (5.7%) DVT incidents in 377 patients (494 limbs) who underwent varicose vein surgery.29 Most DVT was asymptomatic (12/20) and located in the calf (18/20). No reduction in the DVT rate was found among patients who received pharmacologic prophylaxis.

In both ELT and radiofrequency series, DVT is often described as an extension of the thrombus from the SFJ into the CFV. This presentation is worrisome because of the proximal location and the direct correlation with the procedure undertaken. The different patterns of presentation with the aforementioned reported DVTs after GSV stripping are remarkable.29 In fact, the latter were usually distal and had a low tendency to propagation. This fact, together with the lack of association in the article from Hingorani et al25 of DVT with classic thromboembolic risk factors, suggests that they might represent two distinct pathophysiologic entities.

Our experience in 39 patients with 3 cases of thrombus extension into the femoral vein after ELT, enforced by the recent articles of Hingorani et al25 and van Rij et al,29 warrants further studies to better understand the postoperative clinical course of GSV treated for incompetence and the mechanisms underlying postoperative thrombosis. It is our opinion (based on the available data) that both RFA and ELT result in an increased risk of CFV thrombosis when compared with the open procedure. For this reason, we recommend that a postoperative duplex examination be performed within 1 week to detect asymptomatic adverse events. The same recommendation came from a recently published consensus conference on laser treatment of varicose veins.30

The role for pharmacologic prophylaxis remains uncertain. Because the adverse events are so sporadic, only prospective studies specifically addressing the problem can answer the question. Until more evidence is available, we emphasize the importance of early ambulation and compression stockings for patients undergoing endovenous procedures. Careful attention should be paid to all potential factors for increased thromboembolic risk, because these patients will benefit from drug prophylaxis.

In conclusion, the apparent increased risk of early extension of thrombus or DVT after radiofrequency ablation and ELT, according to this series and other recent publications, warrants routine postoperative duplex scanning within a few days, more alertness during these procedures, and patient education on the possibility of such complications. With these precautionary considerations in mind, we continue to offer ELT as an alternative option to patients who are suitable candidates for both laser and open surgical therapy. Prospective randomized studies comparing stripping with new minimally invasive methods are necessary to determine the exact role for ELT and RFA in the armamentarium of the venous surgeon.

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References 

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 Competition of interest: none.

PII: S0741-5214(04)01482-X

doi:10.1016/j.jvs.2004.10.045

Journal of Vascular Surgery
Volume 41, Issue 1 , Pages 130-135, January 2005

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