A prospective evaluation of the outcome after small saphenous varicose vein surgery with one-year follow-up

Article Outline

• Abstract
• Patients and methods
• Results
  • Perioperative details
  • Complications
  • Residual and recurrent veins
  • Follow-up duplex imaging at six weeks (230 legs)
  • Follow up duplex imaging at one year (204 legs)
• Discussion
• Author contributions
• Acknowledgment
• References
• Copyright

Objective

The aim was to examine the effect of various surgical maneuvers during standard surgery for small saphenous varicose veins (SSV).

Methods

This was a prospective cohort study of patients that underwent small saphenous varicose vein surgery. Two-hundred nineteen consecutive patients (234 legs) with isolated primary or recurrent small saphenous varicose veins undergoing surgery were enrolled in a multicenter study involving nine vascular centers in the United Kingdom. Operative technique was determined by individual surgeon preference; clinical and operative details, including the use of stripping, were recorded. Clinical examination (recurrence rates) and duplex imaging (superficial and deep incompetence) were evaluated at six weeks and one year after surgery.

Results

A total of 204 legs were reviewed at one year; 67 had small saphenous varicose vein stripping, 116 had saphenopopliteal junction (SPJ) disconnection only, and the remainder had miscellaneous procedures. The incidence of visible recurrent varicosities at one year was lower after SSV stripping (12 of 67, 18%) than after disconnection only (28 of 116, 24%), although this did not reach statistical significance. There was no significant difference in the rate of numbness at one year between those who had SSV stripping (20 of 71, 28%) and those who had disconnection only (38 of 134, 28%). The rate of SPJ incompetence detected by duplex at one year was significantly lower in patients who underwent SSV stripping (9 of 67, 13%) than in those who did not (37 of 115, 32%) (P < .01).

Conclusion

Stripping of the SSV significantly reduced the rate of SPJ incompetence after one year without increasing the rate of complications.

The majority of patients that are treated for symptomatic or complicated varicose veins have saphenofemoral incompetence with great saphenous varicosities (GSV). A minority, approximately 15%, have isolated incompetence at the saphenopopliteal junction (SPJ) with small saphenous varicose veins (SSV).¹ There is a significant literature discussing optimal means of evidence-based treatment for GSV, but much less for SSV. For example, stripping the GSV has been shown to be an important component of the procedure that minimizes the rate of late re-operation.², ³ Due to anatomical variability at the SPJ, proximity to major cutaneous nerves, and the deep dissection sometimes required, SSV surgery is more difficult and thought to have a higher rate of complications.⁴ In addition, few studies have evaluated optimal methods of surgery, in particular, the potential benefits of flush SPJ ligation and of stripping the SSV. The potential for damage to the sural nerve with resulting neurological deficit has deterred many vascular surgeons from stripping the SSV routinely.⁵ For this reason, a randomized trial of SSV stripping has never been done and seems unlikely to be undertaken in the future. The present study was an observational cohort study of a large group of patients who had surgical treatment for isolated SSV incompetence. The aim was to examine the effects of various components of the procedure (preoperative duplex marking, type of procedure at the SPJ and SSV stripping) on the outcome of surgery up to one year.

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Patients and methods 

This was a prospective, multicenter observational study. Consecutive patients undergoing surgery for isolated SSV incompetence under the care of one of 29 vascular surgeons in nine UK hospitals were enrolled between October 2002 and August 2005. The choice of operative technique was determined by individual surgeon preference, but the details were recorded. The surgeons were all members of the Joint Vascular Research Group (JVRG), and agreed to recruit consecutive patients undergoing surgery for isolated SSV reflux. They prospectively collected clinical process and outcome data, including complications, and follow-up information on all patients for one year. The principal focus of the study was to determine whether various operative maneuvers affected the clinical outcomes or complications. No attempt was made to standardize surgical treatment and surgeons were encouraged to continue their usual methods but to be explicit about them when reporting.

Patients were included if they had surgery for SSV reflux in the absence of reflux in superficial veins elsewhere in the leg. They all underwent preoperative diagnostic duplex imaging by a trained vascular technologist with their legs dependent; incompetence was defined as reverse flow in any named vein for more than one second after squeezing and releasing the calf. Superficial and deep veins were examined below the groin and any incompetence recorded, as well as confirming incompetence of the SPJ. Deep veins were examined at three levels – femoral vein, and popliteal vein above and below the knee. Reflux in any one of these areas was termed segmental; total deep venous reflux was defined as incompetence in all segments examined. The SSV was specifically examined for reflux at three levels: upper, middle, and lower calf. Patients were excluded from the study if they had any proximal GSV incompetence. Any incompetence detected was recorded separately for each level. Patients with deep venous incompetence, and those with recurrent SSV were included. Some surgeons used preoperative duplex marking of the SPJ and this was recorded.

Operative details were recorded at the time of surgery including whether the SPJ was identified during surgery and whether the SSV was ligated flush with the popliteal vein, or some distance from it. The use of SSV stripping was also recorded.

Patients attended hospital six weeks and one year after surgery for clinical examination and duplex imaging. At six weeks, postoperative complications (within 30 days) were collected, specifically including bleeding, infection, deep venous thrombosis (DVT), and nerve injury. At both visits, the presence of any areas of numbness and any visible residual/recurrent varicosities were noted. Duplex imaging was repeated; any incompetence at the SPJ or residual SSV incompetence at any of the three levels was recorded. The deep veins were also re-examined. All follow-up scans were done in the hospital vascular laboratories by the same trained technologists.

Statistical comparison of the various outcomes was done using contingency tables and Chi squared testing. Depending on the degrees of freedom, statistical significance was set at the 5% or 1% level.

The study was approved by the Regional Ethics Committee, and all participating hospitals had institutional review of the protocol. Participating patients gave written informed consent. The data collected were returned to the organizing center for analysis.

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Results 

A total of 219 patients with isolated SSV incompetence were enrolled in the study. This included 15 with bilateral SSV, giving a total of 234 legs studied. Most had primary SSV, but 44 (19%) of procedures were for recurrent SSV. There were 69 men and 150 women, with a median age of 51 years (range, 20 to 84 years). Median age was slightly higher in men (54 years) and in patients with recurrent SSV (54 years). The male to female ratio was the same for primary and recurrent SSV. Most patients had symptomatic, uncomplicated varicose veins (CEAP 2/3 – 186 legs), 31 legs were treated for lipodermatosclerosis (CEAP 4), and 17 for active or healed ulceration (CEAP 5/6). A total of 230 legs were reviewed at six weeks and 204 had a second review at one year. The number of patients enrolled by each of the participating vascular units is shown in Table I.

Table I. Recruitment and retention of trial patients between centers

Perioperative details 

The use of pre-operative duplex marking of the SPJ varied between centers from 33% to 100% of procedures. Duplex marking was used in 125 operations (53% of the total) and was reported as accurate in 113 (90%). The SPJ was successfully identified in 206 (88%) of operations, however, only 148 (63%) underwent flush ligation of the SPJ; 82 (35%) had division of the SSV at a safe distance from the SPJ (simple disconnection) and in four (2%), the SSV was not divided in the popliteal fossa (these patients had phlebectomies only). Seventy-four (32%) SSV were stripped and 23 (10%) had the first 10 cm of the SSV avulsed under direct vision through a separate stab incision; the remainder (137, 58%) had saphenopoliteal disconnection and phlebectomies alone. There was no association between stripping and the type of procedure undertaken at the SPJ. The majority of operations (154, 66%) were done as a day case procedure. All patients had surgery under general anesthetic, except four who had their operation under spinal anesthesia.

Complications 

At six week review, 28 (13%) patients described complications including: 12 delayed wound healing (four wound infections) and 16 miscellaneous minor complications. No patient had a DVT and none of the complications was classified as major. There did not appear to be any influence of surgical technique on the complication rate (Table II).

Table II. Summary of clinical and duplex outcomes according to method of small saphenous vein (SSV) surgery

	Method of SSV disconnection						Method of SSV removal						Total
	Flush ligation		Simple disconnection		Phlebectomies only		Stripped		Proximal 5-10 cm avulsed		Left intact
	No./Tot.	%	No./Tot.	%	No./Tot.	%	No./Tot.	%	No./Tot.	%	No./Tot.	%	No./Tot.	%
6 weeks
Visible residual varicosities	13/143	9	10/79	13	2/4	50	7/71	10	3/23	13	15/132	11	25/226	11
Numbness	38/144	26	21/80	26	3/4	75	20/71	28	4/23	17	38/134	28	62/228	27
Post-op problems	26/144	18	18/81	22	2/4	50	20/72	28	4/23	17	22/134	16	46/229	20
SPJ incompetence	13/145	9	7/81	8	2/4	50	3/73	4	2/23	9	17/134	13	22/230	10
Residual SSV incompetence	68/145	47	37/81	46	2/4	50	26/73	36	11/23	48	70/134	52	107/230	47
1 year
Visible varicosities	28/127	22	21/73	29	3/4	75	14/67	21	4/21	19	35/116	30	53/204	25
Numbness	29/127	23	15/73	21	2/4	50	14/67	21	3/21	14	29/116	25	46/204	23
SPJ incompetence	31/127	24	14/72	19	3/4	75	9/67	13	2/21	10	37/115	32	48/203	24
SSV incompetence	79/127	62	39/72	54	3/4	75	37/67	55	9/21	43	75/115	65	121/203	60

SPJ, Saphenopopliteal junction; SSV, small saphenous varicose veins.

A small number of missing data items has led to inconsistency in the number of observations in each group.

On examination six weeks postoperatively, a total of 62 legs (27%) had a patch of numbness in the operated leg. One patient had a sural nerve injury but the remainder had small areas of altered local sensation consistent with cutaneous nerve injury. There was no significant difference in the rate of numbness between operative techniques: 38 of 144 (26%) after flush ligation, 21 of 80 (26%) after simple disconnection, 3 of 4 (75%) after phlebectomies alone; 20 of 71 (28%) after SSV stripping, 4 of 23 (17%) after 10 cm SSV avulsed and 38 of 134 (28%) after SPJ disconnection alone. The rate of numbness at six weeks was no higher after operations for recurrent SSV (11 of 44, 25%) than primary SSV (51 of 184, 28%).

After one year, 46 (23%) legs still had patches of skin numbness. The rate of late numbness was higher after surgery for recurrent SSV (13 of 43, 30%) than after primary SSV surgery (33 of 161, 20%) but this was not statistically significant. The patient with sural nerve injury had a complete recovery by one year.

Residual and recurrent veins 

Six weeks after surgery, 25 legs (11%) had visible residual varicosities on examination. These were mostly minor, and there did not appear to be any effect of the type of surgery on this rate. The rate of residual varicosities was similar between legs that had SSV stripping and those in which it was left intact (Table II). After one year, 53 (26%) legs had visible varicosities on examination (43 new, 10 residual from six weeks). There was no significant difference in the incidence of new varicosities between those that had flush ligation of the SPJ (24 of 127, 19%) and those that had simple disconnection of the SSV (17 of 73, 23%). There were fewer recurrent varicosities in those that had the SSV stripped (12 of 67, 18%) or the proximal 10 cm of the SSV avulsed (three of 21, 14%) than in those in whom the SSV was left intact (28 of 116, 24%), but this did not reach statistical significance.

Follow-up duplex imaging at six weeks (230 legs) 

On duplex imaging six weeks after surgery, 22 legs (10%) had residual incompetence at the SPJ. There was no obvious association between surgical technique and the rate of residual SPJ incompetence (13 of 145, 9% flush ligation, seven of 81, 8% simple disconnection), nor any effect from stripping (Table II), but the rate of residual SPJ incompetence was significantly higher after surgery for recurrent SSV (nine of 44, 20%) than primary SSV (13 of 186, 7%, P < .01, Chi squared test). The operative techniques for recurrent disease were similar to those for primary SSV (stripping 34% vs. 31%; flush ligation 75% vs. 61%). At six weeks, a total of 107 legs (47%) had some residual SSV incompetence, although this was present in the distal SSV alone in 41 legs. When considering the incidence of any SSV incompetence on duplex imaging after six weeks, there did not appear to be any advantage of stripping (26 of 73, 36%) compared with avulsing 10 cm of SSV (11 of 23, 48%) or simple disconnection alone (70 of 134, 52%). Similarly, preoperative duplex marking did not affect the early outcome. The rate of residual SPJ incompetence was 12/124 (10%) in legs that were marked by duplex, compared with 11/102 (11%) that were either marked with hand-held Doppler or not marked preoperatively.

Follow up duplex imaging at one year (204 legs) 

At duplex imaging one year after surgery, 48 (24%) legs had SPJ incompetence. There was no significant difference in the rate of SPJ incompetence between legs that had flush SPJ ligation (31 of 127, 24%) compared with simple disconnection of the SSV (14 of 72, 19%). However, there was a significantly lower rate of SPJ incompetence after one year in legs that had the SSV stripped (nine of 67, 13%) compared with those that had saphenopopliteal ligation alone (37 of 115, 32%) (P < .01, Chi squared test). The rate of SPJ incompetence in legs that had the top 10 cm of SSV avulsed was also low at one year (two of 21, 10%) but because of the small numbers, this difference was not significantly different from the group that had saphenopopliteal ligation alone. The rate of SPJ incompetence at one year was also higher after surgery for recurrent SSV (14 of 43, 33%) than primary SSV (34 of 160, 21%), but this was not statistically significant.

At one year, a total of 121 (60%) legs had some SSV incompetence although this was in the distal SSV alone in 44. The type of surgery at the SPJ had no effect on this rate (Table II). Nor was there any significant effect of stripping (37 of 67, 55%) compared with avulsion of the proximal five to 10 cm of the SSV (nine of 21, 43%), or SPJ disconnection alone (75 of 115, 65%).

The effect of surgery on the deep veins was examined in 180 legs with complete duplex data recorded both preoperatively and at one year, and using the defined duplex protocol of imaging at three levels. Preoperatively, 113 (63%) had normal deep veins, 60 (33%) had segmental deep venous incompetence (DVI), and seven (4%) had total DVI. After one year, of those with normal deep veins, 11 (10%) developed segmental, and one (1%) had developed total DVI on duplex imaging. The majority of legs with segmental DVI preoperatively (43, 72%) improved and became normal after one year; a further four had a reduced number of incompetent segments, but nine (15%) had an increased number. None developed total DVI. Four of the seven patients with total DVI preoperatively improved: three had a reduced number of incompetent segments and one became fully competent. The remaining three were unchanged.

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Discussion 

The present study was a prospective examination of the outcome of small saphenous varicose vein surgery with objective outcome assessment. The main finding was that stripping the SSV appeared to improve the outcome of surgery up to one year, without increasing the rate of complications, including numbness. The particular strengths of the study were in the large number of patients, the involvement of several vascular units, and the high rate of follow-up to one year (204/234 legs, 87%). Potential weaknesses included the lack of randomization and the fact that individual surgeons were allowed to use their own preferred operative techniques. In addition, several units only recruited small numbers, suggesting either that they were low volume hospitals or that surgeons failed to enroll consecutive patients. Nevertheless, there was no significant difference in the clinical outcomes between the different units (data not shown). Other endpoints such as quality of life scores were not employed. Perforating veins were similarly not assessed.

Vascular surgeons vary in their use of preoperative duplex imaging for varicose veins. While there is some evidence that routine preoperative duplex improves outcomes, this relates mostly to the GSV and evidence is lacking for SSV.⁶ Most UK vascular surgeons (89% in a recent questionnaire study) employ routine diagnostic imaging before SSV surgery because of the difficulty assessing this area by hand-held Doppler, and the variable anatomy of veins in the popliteal fossa.⁷, ⁸ Preoperative duplex marking of the SPJ was done selectively, according to the result of the diagnostic scan by surgeons in the present study, as mirrored by national data.⁹ As in other studies, preoperative duplex marking of the SPJ has not been shown to improve outcomes.¹⁰, ¹¹

It has been suggested that SSV surgery is more hazardous than GSV surgery, and that recurrence is more common.⁴ Perioperative complication rates were low in the present series, as in other reports.¹² There were no major adverse events, and specifically no recorded DVTs; the only one significant (sural) nerve injury resolved completely. Some aspects of the results suggest that there is potential for recurrence in the future. For example, there was a failure to identify the SPJ in 12% of procedures. At six week review, 11% still had visible varices in the calf and in 9.5% the SPJ remained incompetent on duplex imaging. Preoperative duplex marking, and the type of surgery undertaken in the popliteal fossa did not appear to affect these outcomes, however, surgery for recurrent SSV led to a higher rate of residual SPJ incompetence and a higher rate of SSV incompetence in the leg at one month. There were no other differences between the results for primary and recurrent SSV, but the numbers were too small for detailed analysis.

It is commonly believed that stripping the SSV is dangerous. The method of SSV stripping was not standardized in this study, though most surgeons employed perforate invaginate stripping to the mid calf.¹³ Postoperative numbness was common, presumably due to cutaneous nerve damage; the rate was similar whether or not stripping was employed. There was only one recorded sural nerve injury, not in the stripping group. This recovered fully. There was no evidence that stripping was a cause of morbidity in this series. In fact, it appears to be the phlebectomies that are more likely to result in localized cutaneous nerve damage.

It was expected that stripping should reduce the rate of SSV incompetence. Remaining or residual SSV was imaged postoperatively at three levels in the calf. It was a surprise that the rate of SSV incompetence was similar in the two groups, although incompetence was in the distal calf in those who had stripping, since the SSV was usually only stripped to mid calf. Extending the strip to the low calf might improve this finding, though it might increase the rate of nerve damage. It is not known whether the fact that some or all of the SSV remains incompetent might increase the risk of later recurrent veins.

Stripping did, however, significantly reduce the rate of SPJ incompetence on duplex imaging at one year. This finding is potentially important, since it suggests that stripping may reduce the chance of later recurrent veins. The findings were similar when the top 10 cm of the SSV was avulsed, but the number of procedures was too small to be certain of the value of this maneuver.

The type of procedure done in the popliteal fossa had no effect on outcome. Traditional teaching is that optimal results are achieved by flush ligation at the SPJ, yet in a recent survey of vascular surgeons in the UK, 76% stated that they did not routinely expose the popliteal vein, but ligated the SSV at a safe distance from the SPJ.⁹ Flush ligation was employed in a higher number of procedures in this study than in the UK overall (63%), but this did not appear to affect any of the outcomes measured.

The study was conceived before endovenous methods for treating varicose veins were in common use. Both radiofrequency and laser thermal ablation are now used for the treatment of SSV reflux, with high rates of SSV occlusion and patient satisfaction.¹⁴, ¹⁵, ¹⁶, ¹⁷ Ultrasound guided foam sclerotherapy has also become a popular method for the outpatient treatment of varicose veins.¹⁸ Although occlusion rates are lower than for the thermal energy methods, foam sclerotherapy is more easily repeatable, and occlusion rates appear to be higher in the SSV than the GSV.¹⁹ In particular, it seems from the present study that the results of surgery are less good for recurrent SSV; this might be grounds for considering alternative treatment.

There is no doubt that in the next decade there will be much debate about the optimal treatment for SSV reflux. There are few good long term outcome studies, but those available suggest appreciable recurrence rates within five years.²⁰, ²¹ It is likely that the role of surgery will diminish as the endovenous methods disseminate. Data from the present investigation could be used as a standard against which to compare the results of new interventions. It is an interesting observation that it could be concluded from this study that the stripping component of the surgery was more important than the extent of the surgery at the SPJ. This would support a move towards the endovenous methods that principally obliterate the truncal vein. In the meanwhile, there is evidence from this study that standard surgery is effective with minimal complications, and that stripping the SSV improves the hemodynamic result without increasing the rate of significant nerve injury.

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Author contributions 

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Other members of the JVRG who contributed to this study were: Torbay Hospital – Peter Lewis, Ian Currie, Jill Arthur, Marie Hanley, St Mary's Hospital, London – John Wolfe, Mike Jenkins, Duncan Black, Louise Allen; Royal Bournemouth Hospital – Simon Darke, Will Butcher, Lasantha Wijesinghe, Simon Parvin, Sara Baker, Jane Stephenson, Stuart Smith; Bristol Royal Infirmary – Peter Lamont, Frank Smith, Roger Baird, Maria Morgan, Jude Day; Teresa Robinson, Ellie Walker; Royal Devon and Exeter Hospital – Andrew Cowan, John Thompson, Jackie McIntyre, Nicola Walker; Sheffield Vascular Institute – Jon Beard, Marilyn Ireland; University Hospital, Nottingham - Bruce Braithwaite, Richard Simpson, Peter Wenham, Shane MacSweeney, Bill Tennant, Sadhana Chandresakar; Freeman Hospital, Newcastle Upon Tyne – Mike Wyatt, Mike Clarke, Vera Wealleans, Lesley Wilson; Gloucestershire Royal Hospital – Kate Harvey, Rebecca Winterborn, Viv Cannon. The authors also thank Susannah Hoult who designed the data collection forms.

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