Pain in the aftermath of minimal invasive treatment for unilateral incompetence of the great saphenous vein

Abstract

Objectives

Assessment of postprocedural pain after minimal invasive treatment of unilateral incompetence of the great saphenous vein.

Methods

A total of 85 patients treated with endovenous laser ablation (1470 nm) in combination with foam sclerotherapy and evulsions reported postprocedural pain on a visual analogue scale (0–10) during 28 days after treatment.

Results

A mean pain reduction from 3.9 on the first postinterventional day to 0.3 was noted during the observation time. After 28 days, 7% of patients had a visual analogue scale >1. Higher body mass index was strongly associated with more pain during the whole follow-up period (p < 0.01). Higher energy application per cm vein and greater great saphenous vein diameter showed more pain in the first week. Other factors like clinical stage CEAP classification, combination of laser with avulsions and/or sclerotherapy, season of treatment timepoint, and age or sex did not influence postinterventional pain course.

Conclusion

Higher body mass index and higher energy application per cm are associated with more postprocedural pain after endovenous laser ablation.

Keywords

Endovenous laser treatment great saphenous vein varicose veins

Introduction

In recent years, endovenous thermal procedures have become the standard therapy for patients with superficial venous incompetence. Clinical success and recurrence rates are comparable to classic surgical procedures, whereas posttreatment recovery is supposed to be earlier and posttreatment pain significantly lower.^1,2 Endovenous thermal procedures such as endovenous laser ablation (EVLA) can be performed in an outpatient setting causing lower costs compared to conventional surgery.³ These circumstances and growing scientific evidence have led to a great increase of endovenous thermal procedures.^2,3

EVLA is performed with a laser fiber introduced into the lumen of the incompetent superficial vein. By applying different wavelengths, different chromophores are used. Laser devices with higher wavelengths (1320 nm, 1470 nm, and 1940 nm) are targeting water and act specifically on the vessel wall. Lower wavelengths (810 nm, 940 nm, and 980 nm)—used at the earlier stage of the technical evolution—have an indirect heat effect on the venous wall by generating vapor bubbles.^4,5 Peri- and postoperative pain and discomfort are impacted by wavelength, linear endovenous energy density (LEED, J/cm), and type of laser fiber. To date, it is not clear which parameter has the most important impact.^5,6

Studies have shown that higher wavelengths are more likely to provide a better postoperative comfort compared to those with lower wavelengths targeting hemoglobin as a chromophore.^5,7 The later cause more perforations and carbonization by local convection.⁸ These perforations of the venous wall are considered to be an important cause of postoperative pain and bruising.⁹

High-grade thermal damage and carbonization also depend on the amount of applied LEED. If the laser is operated at lower power, it can be expected that the extent of tip carbonization is lower as well. However, once carbonization has formed, a significant portion of the laser power is absorbed regardless of the lower irradiance, resulting in the generation of vapor bubbles and vein perforation.¹⁰

Moreover, the type of fiber tip was found to impact the peri- and postinterventional course as well. Bare fibers are more likely to lead to perforation due to direct contact with the venous wall because of the high temperature at the fiber tip.⁹ Therefore, new fiber types have been developed to minimize this carbonization.^9,10 Coated tip fibers show a significantly lower degree of perforation compared to the bare tip fibers, this applies to both 810 and 1470 nm lasers.^6,9 A coated laser fiber like the NeverTouch™ has a welded glass around the apical part. The increased fiber diameter results in a larger emitting surface and thus lower irradiance and less actual power density by more than 50% compared to the standard bare tip fiber. The effect leads to a homogeneous ablation with less focal charring of the tip, lower tip temperature, decrease of vapor bubble formation, and thus, a lower perforation rate of the venous wall.^9,11

Although there is the above described considerable technical progress of the endovenous laser technique, little is known about patient-related factors triggering pain in the aftermath of laser treatment. Even the gentle endothermal ablative procedure with a 1470 nm device combined with avulsions and/or sclerotherapy causes some postprocedural pain. The aim of this work was the evaluation of this posttreatment pain, its time course for four weeks, and its potentially triggering factors.

Methods

One-hundred and twenty consecutive patients referred for minimal invasive treatment of unilateral great saphenous vein (GSV) incompetence—confirmed by prior duplexsonographic evaluation based on pathological reflux of >0.5 s in the GSV after manual compression of the calf—were asked to take part in the study. Patients were advised to fill out a visual analogue scale (VAS) pain score (0–10, 0 = no pain, 10 = strongest pain) for 28 days from day 1 defined as the day of the intervention. The score was defined to represent the highest sensation of pain or discomfort in the treated leg during each of 28 days.

Exclusion criteria were defined as follows: recurrent GSV incompetence, bilateral GSV treatment, any leg pain for other reasons than varicose veins, any persistent anti-inflammatory medication including Non-Steroidal Anti-Inflammatory Drugs (NSAID), venous ulceration, and history of deep vein thrombosis.

Minimal invasive treatment procedure was standardized: laser was applied using a 1470 nm device (Angiodynamics®, Never Touch, 4 French introducer sheet) under tumescent anesthesia (solution: 500 ml saline, 20 ml Epinephrine®, 10 ml NaBic). Laser power was set at 10 W, the laser fiber was withdrawn at a rate of approximately 0.1–0.2 cm/s. This rate was adapted according to the experience of the operator considering the diameter of the treated vein. In general, an energy application of 50–70 J/cm was considered to be effective. The laser tip was placed right at the confluence of the epigastric vein or at least 0.5 cm distal from the saphenous-femoral junction. All procedures were carried out under local anesthesia.

Side branches were treated with avulsions or with ultrasound guided foam sclerotherapy. The latter was performed with 1–3% polidocanol foam (liquid/air ratio 1:4). The choice of concentration was made based on the diameter of the treated vein, in general using 1%, for larger veins (>1 cm diameter) 3%.

All patients received a single injection of enoxaparin sodium (Clexane®, 40 mg <70 kg body weight, 60 mg >70 kg body weight) at the end of the procedure and were asked to take Rivaroxaban 10 mg/d for further three days. The treated leg was bandaged with a self-stitching bandage (Peha Haft®), and a Swiss class II thigh high compression stocking (23–32 mmHg) was applied over this bandage.

Patients were asked to keep this compression system for two nights and carry on with the stocking during daytime for another 14 days. After this period, compression was advised on demand. Painkillers were not used as fixed regime but advised on demand.

Two follow-up visits were terminated, the first one within seven days after treatment, the second after six to eight weeks.

Several parameters were defined for registration: body mass index (BMI) as kg/m², C-score from the clinical, etiological, anatomical and pathophysiological classification (CEAP) (C0–C6), seasonal periods of treatment (December to February, March to May, June to August, September to November), GSV diameter defined as maximum diameter in standing position at 1–5 cm distal from the sapheno-femoral junction, applied energy per centimeter of the treated GSV (J/cm), and length of the treated segment venous segment (VS).

To evaluate different time frames, mean VAS scores were calculated: d1–d3 (day 1–day 3), d1–d7 (week 1), week 2, week 3, week 4, and for the whole period.

Statistical analyses

To compare between included and not included patients, two-sample t-tests for parametric, Mann–Whitney U tests for ordinal and chi square tests for nominal data were calculated. Nonparametric Spearman’s correlations were calculated to test for the relationship between patient and treatment variables with VAS scores at different time periods. Stepwise linear regression analysis was performed to test for the multivariate influence of patient and treatment variables on VAS scores, total and added r² were shown explaining pain in different time frames. For all comparisons, p < 0.05 was considered statistically significant. Data were analyzed using IBM SPSS Statistics for Windows, version 26.0.

Results

One-hundred and twenty consecutive patients treated for unilateral GSV incompetence were asked to fill out VAS pain scores for 28 days. Thirty-five patients were not included: 28 forgot to score every day and 7 patients were excluded due to incorrect completion of the form.

There was no statistically significant difference of baseline parameters in comparison of the 85 analyzed patients and the 35 subjects not included.

Sixty-five of 85 patients were female (76.5%). Mean age was 49.9 years. Baseline and treatment parameters are presented in Tables 1 and 2.

Table 1.

Baseline parameters of 85 patients included in the analyses.

	Mean (SD)	Median	Range
Age (years)	49.9 (13.1)	48.8	24–80
Weight (kg)	71.6 (15.7)	66.0	50–120
Height (cm)	170 (8)	170	156–195
BMI	24.6 (4.6)	24.2	17–39
Length of treated GSV (cm)	45.3 (16.3)	48.0	10–73
Joule per centimeter	58.9 (5.2)	59.2	46–72
Joule total	2665 (995)	2925	622–4662
Mean diameter junction (cm)	0.8 (0.1)	0.8	0.5–1.1
Mean length of avulsions in the treated leg (cm)	27.1 (16.2)	30.0	0–70

BMI: body mass index; GSV: great saphenous vein.

Table 2.

Categorized values of baseline parameters.

		N	%
Sex	Male	20	23.5
Sex	Female	65	76.5
Age (years)	≤40	17	20.0
	>40–50	29	34.1
	>50–60	22	25.9
	>60	17	20.0
BMI	≤20	10	11.8
	>20–25	43	50.6
	>25–30	22	25.9
	>30	10	11.8
Side	Right	43	50.6
Side	Left	42	49.4
Season	Spring	17	20.0
	Summer	4	4.7
	Autumn	37	43.5
	Winter	27	31.8
C-CEAP	2	28	32.9
	3	32	37.6
	4	25	29.4
VS joule	≤55	17	20.0
	>55–59	23	27.1
	>59–62	25	29.4
	>62	20	23.5
Sclerotherapy	No	16	18.8
Sclerotherapy	Yes	69	81.2
Phlebectomy	No	13	15.3
Phlebectomy	Yes	72	84.7

BMI: body mass index; C-CEAP: clinical stage of CEAP-classification; VS joule: Joule per cm GSV.

Seventy-two patients were treated with additional avulsions (84.7%), and adjunctive sclerotherapy was performed in 69 patients (81.2%). Baseline parameters were categorized for analysis of independent parameters (Table 2).

Pain (VAS 0–10) decreased systematically from a mean of 3.9 ± 2.5 at the first day to 0.3 ± 0.8 at 28 days after endovenous laser treatment (ELVT) (Figure 1).

Figure 1.

VAS (0–10) during four weeks after ELVT: mean, minimum, maximum, Quartiles for each day.

Figure 2 shows the portion of all patients indicating a VAS of 0 (no pain) or a VAS of 1 (very little pain) at various time points. These proportions are reducing linearly, after two weeks, 70% of all patients still had a VAS > 0 and 40% a VAS > 1. After four weeks, this proportion has lowered to 20% and 7%, respectively. Correlations (Table 3) between independent factors and VAS in different timeframes show the BMI to have the most important influence on more pain in the first two weeks after treatment (Figure 3). The same was noted for higher energy (VS J/cm) in the first week (Figure 4). A higher GSV diameter was significantly correlated with more pain at day 1 and week 1 and stayed tendentially correlated with more pain in the second week.

Figure 2.

Kaplan-Meier for percentage of patients with pain VAS > 0 and VAS > 1.

Table 3.

Spearman correlations (rho) of independent parameters with pain at different time points.

	VAS day 1	VAS day 2	VAS day 3	Mean VAS days 1–3	Mean VAS week 1	Mean VAS week 2	Mean VAS week 3	Mean VAS week 4	Mean VAS days 1–28
Female	0.04	–0.07	–0.19	–0.08	–0.18	–0.13	0.01	–0.04	–0.13
Age	–0.24^a	–0.23^a	–0.11	–0.23^a	–0.18	0.02	0.07	0.11	–0.07
Height (cm)	0.05	0.07	0.16	0.11	0.14	0.05	–0.05	–0.01	0.06
BMI	0.23^a	0.21	0.34^b	0.26^a	0.38^c	0.23^a	0.00	0.00	0.23^a
C-CEAP	–0.06	0.03	0.1	0.04	0.08	0.06	0.13	0.15	0.11
VS cm	–0.12	0.05	0.05	–0.01	0.04	0.25^a	0.27^a	0.15	0.17
VS J/cm	0.19	0.30^b	0.29^b	0.28^b	0.29^b	0.04	–0.1	–0.01	0.13
VS total joule	–0.07	0.12	0.12	0.06	0.11	0.24^a	0.24^a	0.14	0.19
Max GSV diameter	0.27^a	0.26^a	0.3^b	0.33^b	0.34^b	0.12	–0.05	–0.04	0.19
Sclerotherapy	0.01	0.04	0.06	0.06	0.05	–0.07	–0.02	0.15	0.01
Phlebectomy	0.09	–0.01	0.03	0.03	–0.01	–0.21	–0.24^a	–0.1	–0.16
Spring	0.16	0.1	0.18	0.18	0.19	0.1	0	–0.1	0.12
Autumn	–0.27^a	–0.18	–0.18	–0.26^a	–0.26^a	–0.19	–0.06	–0.03	–0.22^a
Winter	0.12	0.04	–0.03	0.07	0.05	0.04	0.02	0.07	0.07

Note: colors visualize the direction and the strength of the correlations.

^ap < .05.

^bp < .01.

^cp < .001.

C-CEAP: clinical stage of CEAP-classification; VAS: visual analogue pain scale; BMI: body mass index.

Figure 3.

Pain (VAS 0–10) related to BMI.

Figure 4.

Pain (VAS 0–10) related to energy/cm.

VS (cm) correlated significantly with higher pain only in weeks 2 and 3 and higher clinical stage of CEAP-classification (C-CEAP) only tendentially in weeks 3 and 4. An additional phlebectomy correlated significantly with lower pain in week 3, tendentially also in week 2. Younger patients suffered less pain in week 1 and tendentially in week 2. There was no significant difference in the pain score when compared between sex and side of the treated leg. Moreover, there was no significant difference if patients had additional sclerotherapy (Figure 5). Season of treatment time did not show a significant difference of VAS score when categorized in different treatment periods with exception of significantly (week 1) or tendentially less pain in the second week after ELVT in autumn. The higher values in summer could not be considered since only four patients were treated in this season (Figure 5).

Figure 5.

Pain (VAS 0–10) related to other factors.

Multivariate stepwise regression analysis shows that besides BMI, high energy (J/cm), length of VS, no additional phlebectomy, and higher CEAP add information of more pain in different timeframes to total explained r² between 6% and 17% (Table 4). Higher BMI, as strongest effect, is significant on d1, d3, d1–3, w1, w2, and total mean, explaining 7–13% of the variance of pain. Higher energy shows the only significant effect on d2, d1–3, and w1 and adds 4–8%, whereas longer VS adds 6% on w2. In w3 and w4, only univariate effects were visible: in w3, the absence of phlebectomy and in w4, higher C-CEAP both explain 6% of higher pain each.

Table 4.

Multivariate influence of stepwise linear regression analysis (explained variance, r²) on pain at different timeframes (p < .05).

	r²	Added r²
VAS pain	Total	BMI (+)	VS Joule (+)	VS cm (+)	Phlebectomy (–)	C-CEAP (+)
Day 1	0.07	0.07
Day 2	0.08		0.08
Day 3	0.08	0.08
Day 1–3	0.13	0.08	0.05
Week 1	0.17	0.13	0.04
Week 2	0.14	0.08		0.06
Week 3	0.06				0.06
Week 4	0.06					0.06
Total mean	0.09	0.09

VAS: visual analogue pain scale; BMI: body mass index; C-CEAP: clinical stage of CEAP-classification.

There were no relevant complications like deep vein thrombosis or pulmonary embolism. No readmissions associated with ELVT were noted.

Discussion

This study reports on postprocedural pain after minimal invasive therapy for unilateral GSV incompetence with a 1470 nm Never Touch Fiber.

The course of pain regresses continuously and significantly within four weeks. More than two-thirds of patients do not report any more pain after this period. After 16 days, the mean VAS of all patients regresses to a value less than one correlating to very little pain or discomfort. Thus, a period of around two weeks may be expected to provide some discomfort for the patients after this kind of treatment.

In this study, we did not assess the amount of pain killers used by our patients after the procedure. In the operators’ experience, however, there is not much need for analgetic treatment during the time after the intervention. Most patients report about sporadic use of paracetamol or non-steroidal anti-inflammatory drugs during the first 2–3 days after treatment. Moreover, it is rather impossible to correlate a certain value of the VAS with the use of pain killers.

Higher BMI has the greatest influence on postoperative pain in this series. The impact is strongest during the first two weeks; however, it tends to result in more pain even afterwards. The association of obesity and increased sensation of pain has been investigated in several studies. It is known that adipose tissue is an active endocrine organ excreting many active cytokines and hormones that can combine obesity and pain.^12–14 In addition, there is an increased resistance to venous return in patients with abdominal obesity, which favors venous congestion in the lower limbs.¹⁵ It is also assumed that these patients have a progressive failure of venous valve function during the day, which was shown to result in a higher diurnal leg volume as compared to non-obese patients.¹⁶ These factors may contribute to a slower pain regression and more absolute pain. Moreover, in these patients, there might be an increased need of tumenscence volume due to the deeper localization of the GSV. It is possible that this plus of liquid volume contributes to a more intense postinterventional inflammation of the surrounding tissue. In this study, we did not assess the exact amount of tumeszence and are therefore not able to analyze this point.

Moreover, application of higher energy (J/cm) caused more pain in the first two weeks after treatment. This is in line with scientific evidence suggesting less venous wall damage and perforation with lower values of LEED. It may indicate that a higher wavelength, such as the 1940 nm device, could cause even less posttreatment pain, as the applied LEED would be lower compared to the 1470 nm wavelength investigated in this series. In fact, histologic studies have shown that 1470 and 1940 nm lasers with elevated LEED levels (100 J/cm) are associated with excessive destruction of the vein wall, resulting in a high-grade thermal damage including venous perforation and associated discomfort.^5,17 However, these studies have also shown that higher wavelength lasers at 1940 nm need less LEED (50 J/cm) for the same efficiency and therefore cause less thermal damage.

Furthermore, a bigger GSV diameter and a greater length of the treated segment were correlated with more pain in the postprocedural period. This can be explained by a dose–response relationship between administered energy aiming for permanent closure of the GSV.¹⁷

There was no significant correlation between postprocedural pain and increased C-CEAP stage. This is certainly interesting and somehow unexpected. Higher C-CEAP would seem to correlate with more inflammation and thus more pain.¹⁸ However, the distal point of incompetence of the GSV treated by laser is often located at the proximal thigh region where reflux is communicated to side branches. These are treated with avulsions or sclerotherapy. In this study, an additional use of phlebectomy or sclerotherapy was not associated with increased pain.

There are some limitations of this investigation. The power of included patients is considerable but certainly not enough to draw a definitive conclusion. Moreover, the procedures were realized by the same physician, which may have an important bias on the pain report.

However, this study suggests the time course of pain after this kind of treatment and may thus give some important information, which might be shared by the doctor and the patient prior to minimal invasive procedures. This way, patients will be prepared for the aftermath following the treatment. Unnecessary consultations may be avoided, and prolonged courses of pain may be explained. Moreover, patients with higher BMI and expected higher LEED use could benefit from adapted treatment strategies, e.g. a fix regime of anti-inflammatory drugs during the first days after treatment.

In summary, this study shows the course of pain during four weeks after 1470 laser ablation of unilateral GSV incompetence. Higher BMI and more energy/cm of the treated GSV have the strongest influence on post-procedural pain. Further studies in this field are necessary to understand the underlying mechanisms and thus to develop strategies to minimize posttreatment discomfort after minimal invasive treatment for varicose veins.

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

This was a service quality evaluation. Ethical approval was not required.

Guarantor

SB and TW.

Contributorship

SB and TW researched literature and conceived the study. SB and TW were involved in protocol development and patient recruitment. Data analysis was performed by FA and TW. SB and TW wrote the first draft of the manuscript. All authors reviewed and edited the manuscript and approved the final version of the manuscript.

ORCID iDs

Simon Bossart

Felix Amsler

Torsten Willenberg

References

Rasmussen

Lawaetz

Bjoern

, et al. Randomized clinical trial comparing endovenous laser ablation and stripping of the great saphenous vein with clinical and duplex outcome after 5 years. J Vasc Surg 2013; 58: 421–426.

Brittenden

Cooper

Dimitrova

, et al. Five-year outcomes of a randomized trial of treatments for varicose veins. N Engl J Med 2019; 381: 912–922.

Keo

Spinedi

Staub

, et al. Safety and efficacy of outpatient endovenous laser ablation in patients 75 years and older: a propensity score-matched analysis. Swiss Med Wkly 2019; 149: w20083.

Chen

Chang

Comparing the effectiveness of 1064 vs. 810 nm wavelength endovascular laser for chronic venous insufficiency (varicose veins). Laser Ther 2013; 22: 247–253.

De Araujo

WJB

Timi

JRR

Kotze

, et al. Comparison of the effects of endovenous laser ablation at 1470 nm versus 1940 nm and different energy densities. Phlebology 2019; 34: 162–170.

Kabnick

LSK.

Which is more important for postoperative recovery: laser wavelength or fibers?

J Vasc Surg 2012; 55: 307.

Doganci

Demirkilic

Comparison of 980 nm laser and bare-tip fiber with 1470 nm laser and radial fiber in the treatment of great saphenous vein varicosities: a prospective randomised clinical trial. Eur J Vasc Endovasc Surg 2010; 40: 254–259.

Vuylsteke

Van Dorpe

Roelens

Endovenous laser treatment: a morphological study in an animal model. Phlebology 2009; 24: 166–175.

Stokbroekx

De Boer

Verdaasdonk

, et al. Commonly used fiber tips in endovenous laser ablation (EVLA): an analysis of technical differences. Lasers Med Sci 2014; 29: 501–507.

10.

Verdaasdonk

Holstege

Jansen

, et al. Temperature along the surface of modified fiber tips for Nd: YAG laser angioplasty. Lasers Surg Med 1991; 11: 213–222.

11.

Angiodynamics products information sheet, http://intl.angiodynamics.com/products/NeverTouch-Direct-Procedure-Kit (accessed 17 May 2020).

12.

Kershaw

Flier

JS.

Adipose tissue as an endocrine organ. J Clin Endocrinol Metab 2004; 89: 2548–2556.

13.

Greenberg

Obin

MS.

Obesity and the role of adipose tissue in inflammation and metabolism. Am J Clin Nutr 2006; 83: 461S–465S.

14.

Gold

Flake

NM.

Inflammation-mediated hyperexcitability of sensory neurons. Neurosignals 2005; 14: 147–157.

15.

Willenberg

Clemens

Haegeli

, et al. The influence of abdominal pressure on lower extremity venous pressure and hemodynamics: a human in-vivo model simulating the effect of abdominal obesity. Eur J Vasc Endovasc Surg 2011; 41: 849–855.

16.

Engelberger

Indermühle

Baumann

, et al. Diurnal changes of lower leg volume in obese and non-obese subjects. Int J Obes (Lond) 2014; 38: 801–805.

17.

Proebstle

Moehler

Herdemann

Reduced recanalization rates of the great saphenous vein after endovenous laser treatment with increased energy dosing: definition of a threshold for the endovenous fluence equivalent. J Vasc Surg 2006; 44: 834–839.

18.

Ryan

Eager

Sibbald

RG.

Venous leg ulcer pain. Ostomy Wound Manage 2003; 49: 16–23.