Patient-reported outcomes of endovenous superficial venous ablation for lower extremity swelling

Abstract

Objective

To evaluate the effect of endovenous ablation in patients presenting with leg swelling.

Methods

We identified Clinical, Etiology, Anatomy, Pathophysiology (CEAP) clinical class 3 (C3) patients undergoing endovenous ablation from 21 January 2005 to 19 March 2015 with an 810-nm or 1470-nm laser. Patients were surveyed regarding the degree of edema, use of compression stockings, and satisfaction with the procedure.

Results

A total of 1634 limbs were treated by endovenous ablation for incompetent saphenous veins with or without adjunctive segmental varicose vein microphlebectomy. Of these, 528 limbs were treated for CEAP C3. The average time period from the procedure date until the survey date was 1494 days (range, 562–2795 days). Ninety-two respondents accounted for 130 ablations in 128 limbs with an average venous segmental disease score of 2.7. Ninety-seven limbs (75.8%) had reduced or resolved swelling, 29 limbs (22.6%) were unchanged, and 2 limbs (1.6%) had increased swelling. The vast majority (81%) were satisfied with their decision to have the procedure.

Conclusions

Endovenous ablation for edema secondary to superficial venous insufficiency is effective and has high patient satisfaction. Further investigation is needed regarding risk factors for immediate failure and delayed recurrence of edema.

Keywords

Endovenous ablation patient-reported outcomes lower extremity swelling

Introduction

Superficial venous insufficiency (SVI) of the lower extremity affects approximately 25% of women and 15% of men.^1,2 On the basis of estimates of the San Diego epidemiologic study, more than 11 million men and 22 million women between the ages of 40 and 80 years in the United States have varicose veins.^3,4 The leading cause is superficial venous reflux, which can be treated with endovenous ablation (EVA). Persons with venous insufficiency are classified according to symptoms and signs, and those with edema are Clinical, Etiology, Anatomy, Pathophysiology (CEAP) class 3 (C3). Venous ablation has been proven to be as effective as vein stripping for treatment of varicose veins and venous ulcerations.³ However, it has not been completely evaluated for its specific effect on patients with the presenting complaint of leg swelling.

There are multiple potential etiologies for leg swelling. These include but are not limited to inactivity, weak calf muscle pump function, hypothyroidism, congestive heart failure, hypoalbuminemia, chronic kidney disease, obesity, and medications. These conditions may also be present in patients with venous insufficiency which complicates the determination of how much of a role the incompetent venous system is playing in causing the patient’s edema.

We hypothesized that CEAP class 3 patients would benefit from ablation of the incompetent superficial system but that certain subgroups of patients may not benefit and sought to investigate these matters.

Methods

Data source

After Institutional Review Board (IRB) approval was obtained in 2009, the demographic data (including CEAP class and saphenous vein diameter), procedural details, postoperative course, and imaging of the patients undergoing EVA were collected and entered into a dedicated database that has been prospectively maintained since that time.

From 21 January 2005 through 19 March 2015, patients who were referred for symptomatic varicose veins and underwent saphenous vein endovenous laser ablation (EVA) in our office were initially evaluated in the outpatient vascular clinic based on referrals for leg swelling, symptomatic varicose veins, or venous stasis ulcers. The examination consisted of full history and physical, including CEAP classification. Patients who reported symptoms of edema of the affected limb were classified as CEAP clinical class 3 (C3). In addition, we examined bilateral extremities with ultrasound, identifying saphenous vein reflux in the supine and standing positions. The ultrasound examination protocol in our practice excludes evaluation of perforator incompetence for C2 and C3 patients because insurance coverage is not approved for treatment of incompetent perforators in these patients. All patients were prescribed compression hose as initial treatment and given a trial of conservative therapy before undergoing EVA.

Technique

Patients meeting criteria for EVA (symptoms and failed compression therapy and ultrasound evidence of saphenous vein reflux >500 ms) underwent EVA in the outpatient vascular office using tumescent anesthesia administered by a mechanical pump. Venous access was obtained with a micropuncture sheath using ultrasound guidance. A 0.035-in. guidewire was then inserted through the great or small saphenous vein and exchanged for a sheath. Then, an 810-nm or 1470-nm diode laser (AngioDynamics; Latham, NY, USA) catheter was placed through the sheath. The tip of the laser catheter was placed 2–3 cm from the saphenofemoral junction (SFJ) or the saphenopopliteal junction (SPJ; for small saphenous vein ablations). Tumescent anesthesia (440 mL normal saline, 10 mL sodium bicarbonate, 40 mL 1% lidocaine with epinephrine) was injected into the perivenous space, and the laser treatment was initiated at 12 W of continuous energy for the 810-nm laser and 8 W for the 1470-nm laser. The laser was withdrawn at 1 mm/s and terminated 1 cm above the access site. The pull-back times and joules of energy delivered were recorded at the time of the procedure. If an adjunctive phlebectomy was performed, the standard microphlebectomy technique was employed.

Postoperative care

All patients were placed in compression bandages or stockings postoperatively. The SFJ and common femoral vein (or popliteal and SPJ) were examined with ultrasound immediately after the procedure and again within one week.

Statistical analysis

A survey instrument was created to specifically inquire regarding the amount of edema (preoperatively, immediately post procedure, and currently), the use of compression stockings, and current satisfaction with the procedure (Table 1). An IRB waiver was given for consent and patients were then contacted by email or telephone and administered the survey. The venous segmental disease scores (VSDS) assigns a numerical score ranging from 0.5 to 2 for nine separate segments of the lower extremity with a maximal score for reflux being 10. The VSDS were calculated for the respondents based on the preoperative ultrasound. Deep femoral vein and thigh and calf perforator reflux were not routinely assessed in C3 patients, reducing the maximum possible score from 10 to 8.5.

Table 1.

Post venous ablation survey.

1. How much swelling were you having prior to your procedure?

2. How much swelling were you having shortly after your procedure?

3. How much swelling are you having now?

4. Are you wearing compression stockings?

5. If you are wearing compression stockings how much do they help you?

6. How effective was the procedure in eliminating your swelling?

7. In regards to your leg symptoms only: Now that you know what the results are,would you have gone ahead and had the procedure?

Descriptive statistics on patients’ demographics and clinical characteristics were summarized by mean and standard deviation for continuous variables and frequency and percent for categorical variables. Responses to survey questions were summarized by frequency and percent. To assess the effect of patients’ characteristics on response to survey items, statistical analysis of the data was performed to evaluate risk factors for edema resolution, compression stocking benefit (CSB), and patient satisfaction. Multivariable ordinal logistic regression models were fitted on responses to survey items as dependent variables and age, sex, BMI, VSDS, indicators of diuretics, and microphlebectomy as independent variables. Due to the small number of cases, we did not stratify the analysis by pre-procedure distribution of swelling, that is, whether it was “limited to the foot and the ankle,” “from below the knee to the foot” or “up to the knee and above”. Statistical analysis was performed using SAS 9.4 (SAS Institute, Cary, NC) and we considered p-value < 0.05 to be statistically significant.

Results

From 21 January 2005 through 19 March 2015, 1634 limbs were treated by EVA for incompetent saphenous veins with or without adjunctive segmental varicose vein microphlebectomy. Of these, 528 limbs were treated for CEAP class C3. Responding to the survey were 92 patients accounting for 130 ablations in 128 limbs with a VSDS median (IQR) = 2.5 (1.0–4.0). For the group that responded, the demographic and procedural data are detailed in Table 2. The edema-producing conditions (EPCs) encountered in these patients included congestive heart failure (1), non-diuretic antihypertensive medication use (24), lymphedema (1), and multiple sclerosis (1).

Table 2.

Patient characteristics at surgery.

Age (years) – mean ± SD	58.8 ± 11.9
Sex (female) – n (%)	72 (78.3)
Number of veins per patient – n (%)
1	56 (60.9)
2	34 (37.0)
3	2 (2.2)
BMI – mean ± SD	29.8 ± 6.4
Vein size (mm) – mean ± SD	7.5 ± 3.5
Energy (joules) – mean ± SD	2477.9 ± 1291.8
Time (s) – mean ± SD	245.4 ± 108.9
VSD score – mean ± SD	2.7 ± 1.5
Side –n (%)
Left	60 (46.2)
Right	70 (53.8)
Number of veins – n (%)
1	97 (74.6)
2	33 (25.4)
Veins treated: ASV/GSV/SSV/Both GSV+SSV
ASV	1 (0.8)
GSV	122 (93.8)
LSV	5 (3.8)
Both GSV + SSV	2 (1.5)
History of DVT – n (%)	2 (1.5)
Microphlebectomy – n (%)	70 (53.8)
Anticoagulant – n (%)	26 (20.0)
EPCs – n (%)
No data	20 (15.4)
0	84 (64.4)
≥ 1	26 (20.0)
Diuretics – n (%)	19 (14.6)
Wave length – n (%)
810 nm	58 (44.6)
1470 nm	72 (55.4)

BMI: body mass index; VSD score: venous disease severity score; ASV: anterior branch great saphenous vein; GSV: great saphenous vein; SSV: small saphenous vein; DVT: deep vein thrombosis; EPCs: edema-producing conditions. Note: Number of veins treated refers to number of veins treated per limb with endovenous ablation.

Immediately and one week postoperatively, all ablations were successful in every patient based on ultrasound evaluation.

The survey results are detailed in Table 3. Shortly after the ablation, 100 limbs (78%) had reduced or resolved swelling, 26 limbs (20%) were unchanged, and 2 limbs (2%) had increased swelling. At the time of the survey, 88 limbs (68%) had reduced or resolved swelling, 32 limbs (25%) were at their preoperative baseline, and the 2 limbs that worsened immediately post ablation (1.5%) were unchanged. In the group that did not improve immediately after the procedure, 13 patients noted less and 3 noted more swelling at the time of the follow-up survey. In the group of patients who noted less swelling immediately after the procedure, 20 noted that their swelling later returned to the preoperative level and 5 stated it was worse than before the ablation. In those patients with associated EPCs, 23 of the 27 improved after ablation.

Table 3.

Response to survey items (based on n = 92 patient response and 128 limbs).

	N	Percent
1. How much swelling were you having prior to your procedure?
Limited to the foot and the ankle	27	21.1
From below the knee to the foot	78	60.9
Up to the knee and above	23	18.0
2. How much swelling were you having shortly after your procedure?
None	94	73.4
Limited to the foot and the ankle	9	7.0
From below the knee to the foot	17	13.3
Up to the knee and above	8	6.3
3. How much swelling are you having now?
None (0)	76	59.4
Limited to the foot and the ankle	12	9.4
From below the knee to the foot	22	17.2
Up to the knee and above	16	12.5
Did not answer	2	1.5
4. Are you wearing compression stockings?
Not at all	15	11.7
One third of the time	30	23.4
Two-thirds of the time	27	21.1
More than two-thirds of the time	56	43.8
5. If you are wearing compression stockings how much do they help you?
Not at all	16	12.5
A small amount	10	7.8
A moderate amount	27	21.1
A lot	66	51.6
Did not answer	9	7.0
6. How effective was the procedure in eliminating your swelling?
Not at all	10	7.8
A small amount	3	2.3
A moderate amount	31	24.2
Completely	84	65.6
7. In regards to your leg symptoms only: Now that you know what the results are, would you have gone ahead and had the procedure?
No	24	18.8
Yes	104	81.2

A multivariate analysis of age, gender, body mass index (BMI), diuretic use (DU), microphlebectomy, and VSDS (Table 4) revealed that VSDS and DU were associated with an increased amount of preoperative edema (p<.01) and patients having microphlebectomy had less preoperative edema. Microphlebectomy was the only predictive factor for edema resolution (immediate (p = .02) and delayed (p = .01)). Higher VSDS (p = .01) and DU (p = .03) had a negative impact on CSB. Microphlebectomy predicted high patient satisfaction with edema resolution (p = .01). Age, gender, and BMI had no effect on edema resolution, CSB, or patient satisfaction. The average time period from the procedure date until the survey date was 1494 days (range, 562–2795 days).

Table 4.

Multivariable logistic regression models on survey response outcomes.

Outcome	Effect	OR (95% CI)	p
Q1 – How much swelling were you having prior to your procedure?	Age	0.99 (0.95–1.02)	0.52
	BMI	1.03 (0.97–1.10)	0.32
	Diuretics (yes vs. no)	3.32 (1.08–10.21)	0.04
	Sex (female vs. male)	0.67 (0.25–1.77)	0.41
	MP (yes vs. no)	0.35 (0.15–0.81)	0.01
	VSD score	1.50 (1.12–2.01)	<.01
Q2 – How much swelling were you having shortly after your procedure?	Age	0.97 (0.93–1.01)	0.19
	BMI	1.05 (0.98–1.12)	0.17
	Diuretics (yes vs. no)	2.18 (0.67–7.05)	0.19
	Sex (female vs. male)	2.01 (0.62–6.47)	0.24
	MP (yes vs. no)	0.35 (0.14–0.87)	0.02
	VSD score	1.29 (0.93–1.78)	0.12
Q3 – How much swelling are you having now?	Age	1.00 (0.97–1.04)	1.00
	BMI	1.03 (0.97–1.10)	0.37
	Diuretics (yes vs. no)	1.09 (0.37–3.19)	0.87
	Sex (female vs. male)	2.12 (0.76–5.91)	0.15
	MP (yes vs. no)	0.21 (0.10–0.48)	<.01
	VSD score	1.07 (0.81–1.42)	0.64
Q4 – Are you wearing compression stockings?	Age	1.02 (0.99–1.06)	0.20
	BMI	1.04 (0.98–1.11)	0.19
	Diuretics (yes vs. no)	0.87 (0.32–2.37)	0.78
	Sex (female vs. male)	1.10 (0.45–2.65)	0.84
	MP (yes vs. no)	1.20 (0.57–2.51)	0.63
	VSD score	0.97 (0.75–1.25)	0.81
Q5 – If you are wearing compression stockings how much do they help you?	Age	1.02 (0.98–1.06)	0.30
	BMI	1.05 (0.98–1.12)	0.21
	Diuretics (yes vs. no)	0.29 (0.10–0.85)	0.03
	Sex (female vs. male)	0.87 (0.31–2.43)	0.79
	MP (yes vs. no)	1.35 (0.57–3.16)	0.49
	VSD score	0.69 (0.51–0.92)	0.01
Q6 – How effective was the procedure in eliminating your swelling?	Age	0.98 (0.94–1.02)	0.34
	BMI	0.99 (0.93–1.06)	0.74
	Diuretics (yes vs. no)	1.28 (0.40–4.05)	0.68
	Sex (female vs. male)	0.65 (0.22–1.97)	0.45
	MP (yes vs. no)	7.49 (3.07–18.23)	<.01
	VSD score	0.92 (0.68–1.24)	0.59
Q7 – In regards to your leg symptoms only: Now that you know what the results are, would you have gone ahead and had the procedure?	Age	0.98 (0.94–1.03)	0.39
	BMI	1.00 (0.93–1.08)	0.97
	Diuretics (yes vs. No)	1.66 (0.41–6.63)	0.47
	Sex (female vs. male)	0.30 (0.06–1.47)	0.14
	MP (yes vs. no)	3.67 (1.31–10.24)	0.01
	VSD score	0.97 (0.68–1.38)	0.86

BMI: body mass index; MP: microphlebectomy; VSD score: venous severity disease score. Note: Italicized variables represent those with statistical significance.

Discussion

EVA and radiofrequency ablation are the preferred treatments for symptomatic saphenous reflux.³ The minimally invasive technique allows for immediate quality of life (QOL) improvement, without the morbidity associated with saphenous vein stripping.⁵ Numerous studies have documented the success rates near term and long term for venous ablation for varicose veins.⁶ However, many patients with varicose veins and chronic venous insufficiency also have associated complaints of lower extremity edema. Screening studies have encountered an incidence of 10%.⁷ In our experience, the incidence is much higher and represents 30% of patients referred for varicose vein treatment. This matches the experience of others whose reports are based on patients referred for varicose veins.^8–11 The effect of venous ablation on lower extremity edema has not been studied, and the results are not clearly defined. For example, it has not been known what effect gender, age, BMI, associated deep system reflux, other contributing conditions, and DU have on outcome.

There are several venous QOL survey instruments available to assess the results of treatment for venous insufficiency and many of these include questions regarding limb swelling.^12–14 Edema can be measured with different techniques ranging from the simple, such as limb circumference measurements, to the more sophisticated techniques that measure limb volume. Yet, edema can vary throughout the day and from day to day as well. The initial venous clinical severity score (VCSS) graded the swelling component based on how much ankle swelling was present in the morning versus in the afternoon or evening.¹ The revised VCSS grades the amount of swelling by location (ankle, up to the knee, above the knee).¹⁵ While we could have surveyed our patients using one of the many QOL instruments available, there is already ample evidence that QOL scores improve significantly after treatment of venous insufficiency.¹⁶ We chose to focus solely on the edema response to the EVA for this reason and because these patients had not been administered a pre-treatment QOL survey. Patient-reported outcomes are increasingly sought after and we chose to use the patients’ subjective opinions regarding the response to edema. This approach is consistent with current patient-centered outcomes research advocacy statements related to venous insufficiency research.^7,17,18 With regard to the patients’ appreciation of their condition, it has been noted that their subjective evaluation of their symptoms has a greater psychological impact on QOL than the objectively documented C class.⁹ For these reasons, we created our own survey to examine this question and based the format of the edema resolution question on the revised VCSS format.

In our study population, the amount of edema was significant. Over 75% had swelling above the ankle and almost 20% had swelling above the knee. The results of this survey demonstrate an excellent early improvement in lower extremity edema after ablation and this benefit persists in most over time. Our immediate response rate is similar to the 90% response noted by others with a mean follow-up of nine months.¹¹ Some patients who do not respond immediately will report less swelling later. This phenomenon was also seen in a previous study, wherein more patients reported less swelling as time progressed in the first year following ablation.¹⁹ In another study, patients continued to show improvement for up to two years following treatment.⁸ Theoretically, this improvement could be secondary to improvement in deep system function. It has been demonstrated that, following ablation of the superficial system, deep system reflux will abate or resolve.^20–22 We would have to follow a cohort of C3 patients post EVA with regular surveillance by lower extremity venous ultrasound to determine whether this was the reason for continued improvement in some patients.

Overall, in 10 limbs, the swelling was worse in long-term follow-up than prior to the procedure, and survival analysis demonstrated a gradual but progressive loss of the initial edema resolution over time. Proebstle et al. demonstrated that when followed for up to four years, some patients begin to show worsening of symptoms.⁸ The mean follow-up in our study was four years, with 64 limbs followed for more than four years. This suggests the reduced long-term benefits in edema resolution in this study may be related to the length of follow-up. One might speculate that with longer follow-up, more recanalized saphenous veins might be encountered, and that this would explain the higher number of late failures. While this was found in one report with six-year follow-up, recanalization did not correlate with recurrence or progression of clinical symptoms.²³

This suggests that other factors may be responsible. However, age, gender, BMI, and DU had no impact on the ablation results and therefore should not be factored into a clinician’s decision to offer or withhold ablation treatment. None of the EPCs negatively impacted the results either. With regard to the impact of deep venous insufficiency, approximately 20–30% of patients with symptomatic chronic venous insufficiency have combined superficial and deep venous reflux, and this percentage is higher in patients with Class C3 disease and higher.^20,24 In our study, patients with deep venous insufficiency, as documented by higher VSDS scores in the multivariate analysis, did not appear to be negatively impacted for the survey questions pertaining to patient satisfaction and edema response. This suggests but does not prove that patients with deep venous insufficiency may also benefit from superficial venous ablation.

There is still some controversy regarding the necessity and timing of microphlebectomy during venous ablation procedures.²⁵ Some have suggested a staged approach because many patients will improve after ablation alone.^26–28 Others have argued for a combined approach since many patients will later need microphlebectomy, and there is a clear benefit in the early postoperative QOL and VCSS scores of patients who have the two procedures in the same time.^29–31 We found that microphlebectomy was associated with improved results and therefore recommend that it be considered in all patients having an ablation who complain of swelling.

Interestingly, the two limbs that worsened immediately after the procedure were in the same patient and our rate is similar to others.⁸

Our patients reported a high use of compression stockings. This is surprising given that most of the patients reported no swelling, although this has been noted previously. The Bonn investigators stated, “The compliance with compression therapy is astonishingly high in the patients under medical compression stocking (sic) therapy.”³²

While most of the patients using the stockings noted a benefit, patients with deep vein incompetence, as reflected by a higher VSDS, did not benefit as much from the stockings. We did not investigate what strength of stockings the patients were using. It is possible that the patients with higher VSDS were being undertreated in this regard.

Other investigators have identified DU as a negative predictor of relief of swelling after combined iliac vein stenting and superficial venous ablation procedures.³³ While DU did not adversely affect the edema response in our study, it did negatively impact the benefit of compression stockings. In these patients, there most likely was a comorbid medical condition contributing to the edema, and the prescribed stockings would thus have been less effective. While we still recommend ablation and microphlebectomy for patients taking diuretics, we suggest that these patients be fitted with a higher pressure stocking post procedure to gain more benefit from compression stocking use.

For a subjective symptom such as edema, patient satisfaction with the result is the ultimate standard by which the treatment should be judged.⁷ Nearly 90% of the survey respondents felt that the procedure either moderately or completely reduced the swelling. Over 80% endorsed the procedure and felt that they had made the right decision. Patients who had a simultaneous microphlebectomy were more likely to be in these two groups. This in line with other reports documenting better patient satisfaction, if microphlebectomy was performed at the time of ablation.²⁵

There are several limitations to this study. We had only a 25% response rate to the survey, which could have led to bias in patient selection. The absence of QOL data also limits our ability to detect and define selection bias in this study. Patient recall could have been erroneous for the preoperative amount of edema and the immediate response since the survey was administered after the procedure. Our survey did not ask when the patients felt they had achieved the most benefit from the procedure eliminating our ability to do a hazard analysis. We did not re-evaluate the patients at the time of the survey with an ultrasound to detect late failure of the ablation as well as to re-assess the deep venous system for improvement or worsening. We do not have any information on patients who could have been evaluated for ablation but to whom this was not offered or who did not accept it. We had only a few patients with EPCs that were not drug related, so the results of this study cannot be generalized to patients with heart failure, lymphedema, or multiple sclerosis. Finally, the small number of cases excluded an analysis of the pre-procedure distribution of leg swelling.

Conclusion

Patient-reported outcomes for venous ablation for edema secondary to SVI is effective and has high patient satisfaction, but the benefit does wane over time. Performing microphlebectomy during EVA improves edema response and patient satisfaction. Higher VSDS is predictive of increased preoperative edema but not edema response or patient satisfaction. Age, gender, and BMI are not predictive of edema response or patient satisfaction. Overall, patient satisfaction is very high and most patients endorsed the procedure as effective and would undergo EVA again. Further investigation remains to be done regarding risk factors for immediate failure and delayed recurrence of edema.

Footnotes

Declaration of Conflicting Interests

The author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Funding

The author(s) received no financial support for the research, authorship, and/or publication of this article.

Ethical approval

The Baylor Scott & White Institutional Review Board reviewed and granted approval for this project.

Guarantor

WS.

Contributorship

WS conceived and designed the project, analyzed the data, and authored the article; RS and PD collected the data; GOO provided the statistical analysis of the data and contributed to the writing of the article. All authors have reviewed, edited, and approved the final version of the article.

Acknowledgements

The authors would like to express their gratitude to Kathleen Richter who edited and assisted in the preparation of the article. This article was presented at the 46st Annual Meeting of the Society for Clinical Vascular Surgery, Plenary Session on 23 March 2017, Orlando, Florida.

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