Endovenous laser treatment of the short saphenous vein: Efficacy and complications

Article Outline

• Abstract
• Methods and materials
  • Patient selection and criteria
  • Technique
  • Follow-up protocol
  • Statistical analysis
• Results
• Discussion
• Conclusion
• Author contributions
• Acknowledgment
• References
• Copyright

Objective

The study was conducted to assess the efficacy and rate of complications of endovenous laser treatment (EVLT) of the short saphenous vein (SSV).

Methods

During a 17-month period, 210 (187 patients) with SSV incompetence documented by duplex ultrasound studies were treated with EVLT using a 980-nm diode laser. Duplex ultrasound examinations were performed on the day of the procedure, within the first week, and 2 to 11 months after the procedure (mean follow-up, 4 months). Clinical examinations were performed at 2 weeks and 6 weeks. Patients were assessed for deep venous thrombosis (DVT), nerve injury, and resolution of symptoms.

Results

All procedures were technically successful, and in the 126 patients (60%) who completed final follow-up scanning, 96% of SSVs remained closed. Three patients (1.6%) had numbness at the lateral malleolus at the 6-week follow-up. DVT, defined as a tail of thrombus protruding into the popliteal vein, was not detected in any limbs at the initial duplex study, but was noted in 12 limbs (5.7%) at the 1-week follow-up examination. Nine patients were treated with 3 days to 3 months of fractionated heparin and Coumadin (Bristol-Myers Squibb, Princeton, NJ), and there were no DVT extensions or pulmonary emboli. The anatomic configuration of the saphenopopliteal junction was the only factor predictive of DVT.

Conclusions

Intermediate-term results of EVLT of the SSV demonstrate that the technique is effective at eliminating SSV reflux and affording symptomatic relief. The incidence of nerve injury is low, but the incidence of DVT is higher than reported for the great saphenous vein. Anatomic features of the SSV may predict patient risk for DVT.

Venous incompetence is a common medical condition that causes lower extremity pain, fatigue, and swelling in millions of patients. Valvular incompetence of the great saphenous vein (GSV) is the most frequent cause of venous insufficiency, but incompetence of the short saphenous vein (SSV) is not uncommon: up to 20% of patients with varicose veins have incompetence of the SSV.¹

Endovenous laser therapy (EVLT) of the GSV has been proven to be safe, with long-term results that are comparable or superior to traditional high ligation and stripping.², ³, ⁴ Several large series have included SSV ablations, but studies looking specifically at the success rate and risks associated with laser ablation of the SSV have included only small numbers of patients.⁵

Anatomic differences between the saphenofemoral junction and the saphenopopliteal junction, as well as the proximity of the sural nerve to the SSV, are two reasons why study results of endovenous laser ablation of the GSV may not be applicable to the SSV. The purpose of this study is to report on the effectiveness and safety of laser ablation of the SSV from a large number of patients from a single center.

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Methods and materials 

Patient selection and criteria 

The study was a prospective consecutive enrollment of 187 patients (210) limbs that underwent laser ablation of the SSV. Patients had preoperative documentation of SSV reflux using a GE LOGIQ 9 duplex ultrasound (GE Healthcare, Waukesha, Wisc). It was noted during the study period that our patients had three anatomic patterns of the SSV, which we have classified as type A, B, and C (Fig 1). Anatomic classification was made before ablation:

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• Fig 1. 

  Anatomic patterns of the short saphenous vein(SSV).

These SSV anatomic classifications are not standard or previously defined and are classifications that we have proposed.

All patients had a clinical evaluation to document varicosities and symptoms according to the CEAP classification. Digital photographs were obtained to document varicosities, skin changes, and ulceration. Patients with significant peripheral arterial disease, significant deep venous insufficiency with obstruction, and pregnant patients were not treated.

Technique 

All patients were treated in a clinic setting with oral or intravenous benzodiazepine sedation, or both. Patients were placed in the prone position, and the SSV was accessed using a micropuncture technique under ultrasound guidance. A 4F sheath was introduced into the SSV and advanced to cover the entire desired treatment length. A laser fiber was then exposed out of the tip of the sheath, and the sheath and fiber were pulled back to ’2 cm from the saphenopopliteal junction.

Ultrasound guidance was used to deliver perivenous tumescence along the entire length of the vein. Collapse of the saphenopopliteal junction was verified and that the cuff of tumescent fluid was at least 2 cm in diameter around the SSV. After adequate tumescent cuff was achieved around the vein, laser energy was delivered with a 980-nm diode laser (AngioDynamics Inc, Queensbury, NY) in continuous mode. Pullback was at a rate of 3-mm to 5-mm per second, with active power of 10 to 14 watts.

At least one concomitant treatment, such as EVLT of the GSV, perforator ligation, microphlebectomy, or sclerotherapy, or a combination, was performed on 94% of patients (Table I) at the same time as EVLT of the SSV. No patients had simultaneous treatment of the contralateral limb.

Table I. Concomitant treatments

Treatment	Limbs, n (%)
GSV EVLT	156(74)
Sclerotherapy	120(57.1)
Perforator Ligation	136(64.8)
Microphlebectomy	35(16.7)

GSV, Great saphenous vein; EVLT, endovenous laser treatment.

After completion of the procedure, compression pads were placed over the treated area, and a 20 to 30 mm Hg graduated compression stocking was placed on the treated limb. Patients ambulated immediately and were encouraged to walk on the day of the procedure. Patients wore the class II compression stockings 24 hours a day for 2 days and then during the daytime for 2 weeks. Nonsteroidal anti-inflammatory drugs were encouraged for the first 2 weeks after therapy.

Follow-up protocol 

Patients had a duplex ultrasound examination using a GE LOGIQ 9 machine on the day of the procedure and again 2 to 4 days later. The original design of the study was to obtain a final duplex ultrasound study 3 months after the procedure; however, the final follow-up scan was at 2 to 11 months postprocedure (mean follow-up, 4.0 months). The duplex scans assessed for the presence a DVT and for SSV closure. A DVT was defined as clot extending beyond or into the saphenopopliteal junction. If a DVT was detected at any time during follow-up, additional follow-up scans were obtained to rule out progression of the thrombus.

Patients had clinical follow-up visits at 2 weeks and 6 weeks after the procedure. At this visit, the extremity was examined and photographed, and the presence or absence of varicosities, skin changes, and ulceration was noted. Patients were examined for nerve injuries and were asked about changes in their level of extremity discomfort compared with before the procedure.

Statistical analysis 

Logistic regression with generalized estimating equations (GEE) was used to quantify the association of selected risk factors with the incidence of DVT and closure. The risk factors considered included gender, leg side (right, left), preoperative presence of ulcer, preoperative presence of stasis, preoperative presence of pain, anatomy type (A, B, or C), active power (in watts), and age. GEE was used to adjust for the statistical dependence of multiple limbs operated on for some of the patients.

The estimated effect of the risk factors is presented in terms of the odds ratio, its confidence interval (CI), and P value. When no cases of DVT occurred among patients included in one of the categories of a risk factor (eg, ulcer present compared with ulcer not present), the odds ratio cannot be estimated, and we simply present the percentage of cases with DVT in each category and a P value from Fisher’s exact test for the null hypothesis that all categories of the risk factor have the same DVT rate. The same approach was used for the analysis of closure and closure rates.

The logistic regression models for closure were done with and without adjustment for the follow-up time. The time adjustment had a minimal impact on odds ratios, CIs, and P values, and thus only results without the time adjustment are presented.

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Results 

Endovenous laser ablation of the SSV was performed on 210 limbs in 187 patients during a 16-month period at a single clinic by three vascular surgeons. Concomitant GSV reflux was present in 156 limbs (74 %), and these limbs underwent EVLT of both the SSV and the GSV. EVLT of the SSV alone was done in 54 limbs. Significant perforator vein incompetence was seen in 65% of limbs.

Patient demographics and CEAP clinical classification of limbs that underwent GSV and SSV ablation vs SSV ablation alone are summarized in Table II. According to the anatomic classification the SSV that we had defined, 88 (43 %) had type A anatomy, 69 (33%) had type B anatomy, and 52 (24%) had type C anatomy. Anatomic classification was missing for one limb.

Table II. Demographics and CEAP classification

	GSV + SSV EVLT n = 156 (%)	SSV EVLT alone n = 54 (%)	All limbs n = 210 (%)
Age (mean, range)	52(14-89)	54(35-85)	53(14-89)
Gender (% female)	85	94	88
Limb (right/left)	78/78	31/23	109/101
CEAP classification
Class 2	106(69)	42(78)	148(70)
Class 3 and 4	42(27)	10(19)	52(25)
Class 5 and 6	8(5)	2(4)	10(5)
Presence of pain (%)	97	85	92

GSV, Great saphenous vein; SSV, short saphenous vein; EVLT, endovenous laser treatment.

The procedure was technically successful in 100% of limbs. At the initial follow-up duplex scan performed 2 to 4 days after the procedure, 100% of SSVs were occluded. At the first follow-up duplex scan, 12 (5.7 %) limbs were found to have a DVT, but no DVTs were present in any limb at the final follow-up scan 2 to 11 months postprocedure. A DVT was defined as thrombus extending into the popliteal vein from the saphenopopliteal junction (Fig 2). All of the DVTs discovered were nonocclusive and were visualized as a tail of thrombus extending beyond the saphenopopliteal junction. The mean length of this tail was 1.5 cm (range, 0.3 to 4.0 cm).

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• Fig 2. 

  Deep venous thrombosis is shown extending into popliteal vein in transverse and cross-sectional views (SSV, short saphenous vein).

The study had no protocols for treatment of the DVTs, and clinical treatment was left to the discretion of the surgeon who had treated the patient. Seven (58%) of the limbs with DVT were treated in the first 6 months of the study. The distance the clot extended into the popliteal vein, the mode of treatment, and the duration of treatment of all DVTs found in the study are summarized in Table III. All patients with DVTs were treated or observed until a duplex ultrasound scan showed the clot was completely resolved. No clot extensions were noted during the study period, and there were no known pulmonary emboli.

Table III. Treatment of deep venous thrombosis

DVT, Deep venous thrombosis.

A statistical analysis was performed to ascertain factors that would increase the risk for DVT (Table IV). No patients with type C anatomy had a DVT. Because limbs with this anatomic pattern had no connection between the popliteal vein and the SSV, DVT in these limbs would be theoretically very improbable. In the analysis, only anatomic subtype was predictive of DVT. Patients with type B anatomy had an odds ratio of 0.23 (95% CI, 0.05 to 1.10) of DVT compared with type A anatomy (P = .07), whereas those with type C anatomy had a statistically significantly lower risk of DVT than type A anatomy (P = .013). Odds ratio could not be calculated for type C anatomy because there were no DVTs in these patients.

Table IV. Risk factors for deep venous thrombosis (univariate analysis)

Risk factor	N	DVT (%)	OR (95% CI)⁎	P⁎
Gender
Female	182	6.6	—	.4†
Male	28	0.0	—
Leg side
Left	101	6.9	1.00
Right	109	4.6	0.64(0.20-2.09)	.5
Ulcer
No	199	6.0	—	.5†
Yes	11	0.0	—
Stasis
No	148	6.8	1.00
Yes	62	3.2	0.46(0.10-2.16)	.3
Pain
No	13	0.0	—	.5†
Yes	197	6.1	—
Ulcer, stasis or pain
No	11	0.0	—	.5†
Yes	199	6.0	—
Anatomy type
A	88	11.4	1.00
B	69	2.9	0.23(0.05-1.10)	.07‡
C	52	0.0	—	.013§
Watts
<12	98	7.1	1.00
≥12	112	4.5	0.61(0.19-1.98)	.4
Age (per 10 years)∥	210	—	0.99(0.62-1.57)	.97
Watts (per 1 unit)¶	210	—	0.81(0.52-1.27)	.4

DVT, Deep venous thrombosis; OR, odds ratio; CI, confidence interval.

Four patients (2%) did not return for the 6-week clinical follow-up, and six patients (3%) were treated <6 weeks from the end of the study period and therefore had not yet had a 6-week follow-up examination. Of the patients who had complained of pain associated with their venous insufficiency, 187 limbs were available for 6-week follow-up and 180 (96%) limbs were pain free. Of the 54 patients with SSV incompetence alone, 46 complained of pain before the procedure, and 45 (98%) reported resolution of pain after the procedure.

Ten limbs had ulceration, five at the medial malleolus, four at the lateral malleolus, and one just lateral to the tibia above the ankle in an area of trauma. All limbs showed ulcer healing after the procedure. In the 10 limbs with ulcer, EVLT of both the GSV and SSV was performed in eight, and EVLT of the SSV only was performed in two. In 200 limbs (187 symptomatic, 13 nonsymptomatic) available for 6-week follow-up, no visible varicose vein branches remained, as verified by before-and-after digital photographs in 143 limbs (71%), and some remaining varicosities were visible in 57 limbs (29%).

Patients were examined for dysesthesias and numbness at the 2-week and 6-week follow-up. Numbness was found at the lateral malleolus or distal posterior calf in three limbs (1.6%). No patients complained of dysesthesias in the back of the calf or lateral malleolus. Two of the patients with ankle numbness had also undergone microphlebectomy of vein branches near the lateral malleolus.

Final follow-up scans were obtained in 126 limbs (60%). Recanalization of the SSV was seen in five limbs (4%). Table V describes duplex ultrasound findings for each of the recanalized limbs. None of the patients with recanalized SSV segments complained of recurrent symptoms. A logistic regression analysis of risk factors for DVT was performed to assess risk of recanalization. The same variables as investigated for the risk of DVT were analyzed, and no factors were found to be associated with increased risk of recanalization.

Table V. Description of recanalized short saphenous veins

EVLT, endovenous laser treatment.

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Discussion 

EVLT of the GSV has been widely accepted as a treatment for primary varicose veins, but is less often used in treatment of SSV reflux. Valvular incompetence of the GSV is the most common contributor to primary varicose veins; however, reports of patterns of reflux show that between 13% and 20% of patients have SSV reflux as well.¹, ⁶ Fewer reports of EVLT treatment of the SSV have been published. Ravi et al³ reported the largest current series in 2006, which consisted of 981 patients and included 101 SSV procedures. In 2003, Proebstle et al⁵ reported specifically on the treatment the SSV in 41 limbs using a 940-nm diode laser.

Reluctance of practitioners to use EVLT in the treatment of SSV incompetence may be related to concerns about the proximity of the sural nerve to the vein as well as concerns about popliteal thrombosis. Saphenous neuralgia is a well-known complication after GSV stripping, particularly below the knee.⁷, ⁸, ⁹ Injury to the sural nerve,¹⁰, ¹¹, ¹² and even to the tibial nerve,¹³ has been reported with SSV stripping. Although most published reports of EVLT of the GSV note that saphenous neuralgia after treatment is either absent² or uncommon,¹⁴ we had noted in our own practice that approximately 3% of patients noted numbness at the ankle at the initial follow-up after EVLT of the GSV (personal unpublished data).

Proebstle et al⁵ reported paresthesias in four (11%) of 33 patients who had SSV treatment with EVLT. The median duration of paresthesia in these patients was 6.5 weeks (range, 3 to 8 weeks).⁵ Only three patients (1.6%) in our study complained of numbness at the 6-week follow-up. In only one of these patients could EVLT alone be implicated in causing numbness, because two of the patients also had microphlebectomy of large varicose vein branches at the lateral malleolus. None of the patients found the numbness to be a significant concern.

We have noted that a substantial fascial sheath almost invariably surrounds the SSV that makes creation of a large cuff of perivenous tumescence quite simple. The ease of adequate tumescence of the SSV, which theoretically separates the nerve from the vein, is likely why the incidence of sural nerve injury was low in this study.

The incidence of DVT with varicose vein surgery has not been extensively investigated, but may be as high as 5.3%, as shown in a recent study by van Rij et al.¹⁵ Risk of DVT with EVLT of the GSV in reported series varies from 0% to 7.7%.², ³, ¹⁶, ¹⁷ In the first 206 GSVs treated with EVLT in our practice (2002 to 2004), 1.9% had DVTs.¹⁸ All of the DVTs in our patients were a nonocclusive tail of thrombus extending into the femoral vein, similar to the appearance noted by Mozes et al.¹⁷

Differences in rates of DVT may be related to variability in technique, timing of follow-up ultrasound, or the definition of DVT. There are no published criteria defining DVT after EVLT of the GSV or SSV. The criteria that we used—any protrusion of clot into the deep vein—is admittedly very conservative, and it is possible that some clot extensions into the common femoral vein that we defined as DVTs would not have been regarded as DVTs by other authors. No DVTs were observed after EVLT of the SSV by Ravi et al,³ and a DVT was noted in one (3%) of 33 patients by Proebstle et al.⁵

Our incidence of DVT after treatment of the SSV was 5.7%, higher than in the other reported series. The reason for this difference is unclear, because patient demographics and described techniques are similar in all three series. It is unlikely that the difference in laser wavelength (980 nm in our study vs 940 nm in the other studies) would explain the higher rate of DVT in our study.

Compared with the series by Ravi et al, our patients had earlier initial postprocedure duplex scans (day 2 to 4 compared with 2 weeks). We chose to perform the first follow-up duplex scan at this interval because we required all patients to wear constant compression for 48 hours, which made earlier scanning difficult. Some patients had their first follow-up scan at 3 to 4 days because of an intervening weekend. It is possible that early scanning picks up minor DVTs that would otherwise regress. The rate of DVT in the last 12 months of the study was 3% (5/168 limbs), implying that even though the surgeons had significant experience with EVLT of the GSV at the beginning of the study, a learning curve still exists in the treatment of the SSV.

The influence of the anatomy of the saphenopopliteal junction on the risk of DVT is not surprising. We and other authors¹⁹ have noted the importance of withdrawing the tip of the laser distal to the inferior epigastric vein when treating the GSV. Theoretically, this preserves flow at the saphenofemoral junction, which in turn may prevent extension of thrombus into the femoral vein. The branching pattern at the popliteal junction is quite variable as reported by several anatomic duplex studies.²⁰, ²¹

The investigation by Delis et al,²¹ found that the Giacomini vein was present as a tributary or trunk projection in 70.4% of limbs. We found that the Giacomini vein was the sole termination of the SSV in 24% of limbs (type C) and was a main SSV tributary in 33% of limbs (type B). The remaining 43% of limbs (type A) were at highest risk of DVT: 11.4% compared with 2.9% of limbs with type B anatomy, and 0% of limbs with type C anatomy. The reason for the increased risk in these limbs is apparent: patients with type C anatomy have no significant risk of DVT because of the absence of communication between the SSV and the deep veins, and patients with type B anatomy have the benefit of flow from the Giacomini vein into the saphenopopliteal junction to maintain patency. The Giacomini vein is analogous to the inferior epigastric vein in EVLT of the GSV, and in patients with type B anatomy, we attempt to position the laser fiber distal to the termination of the Giacomini in the SSV.

These findings have relevance in counseling patients before the procedure about their risk of DVT and also may suggest which patients should have prophylactic anticoagulation. Further study would be required to document whether prophylactic anticoagulation prevents DVT in patients undergoing EVLT.

Although we had no set protocols for anticoagulation or observation of patients with DVT, clot regression and resolution was noted in all patients during the study period, regardless of mode of treatment. Hypercoagulable state panels were not assessed on patients with post-treatment DVT. None of the patients with DVT had an adverse outcome such as post-thrombotic syndrome or pulmonary embolus. Postprocedure symptoms in the patients with DVT were indistinguishable from those patients without DVT, and diagnosis was made solely from routine duplex imaging. Only one patient with a minor DVT (0.3 cm) was observed, without treatment, so it is uncertain how these patients would have fared without anticoagulation. The uniformly good outcomes and lack of symptoms that these patients have raised the question of whether these minor clots need to be treated at all. Further study would be required to answer this question.

The initial technical success was excellent (100%), and patient outcomes were also quite respectable, with 96% of patients being free from pain, and healing occurred in the 11 patients ≤6 weeks postprocedure. Caution must be used, however, in the interpretation of the clinical outcomes for relief of pain and ulcer healing. Most patients underwent concomitant therapies, and this study does not isolate which benefits came from the EVLT of the SSV vs the concomitant therapies. These are very early results; however, longer-term outcomes for SSV EVLT documented by Proebstle et al⁵ (39 patients, 6 months) and Ravi³ (7 patients, 3 years) suggest that the benefit of the procedure is durable.

Partial recanalization of the SSV was found at 3 months in five limbs (4%) in our study. The clinical significance of the recanalization of the SSV is uncertain, because in each case, the SSV remained small and symptoms/varicosities had not recurred. Although 95% of patients returned for 6-week clinical evaluations, only 60% of limbs had a final follow-up duplex scan, limiting definitive conclusions about mid-term recanalization of the SSV.

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Conclusion 

To our knowledge, this series represents the largest number of SSVs treated with EVLT in the literature to date. Our data demonstrate that EVLT of the SSV is feasible and safe, and has excellent clinical outcomes in combination with concomitant therapies where indicated. The incidence of nerve injury is acceptably low and not clinically significant. The incidence of DVT was not negligible, although no patients had an adverse outcome related to DVT or anticoagulation. The lack of distinguishing symptoms in patients with DVT compared with those without DVT highlights the importance of early postprocedure duplex ultrasound imaging to demonstrate this complication. Anatomic factors as determined by preoperative duplex scanning may be helpful in predicting which patients are at highest risk for DVT. Further investigations may ascertain if prophylactic anticoagulation is warranted in some patients and whether therapeutic anticoagulation for documented DVT is necessary.

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Author contributions 

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We thank Holly Covert, Beverly Kobs, and Aaron Ebert, BS, RVT, for their help in the preparation of this manuscript.

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