Abstract
Objective:
Venous insufficiency is commonly bilateral, and patients often prefer single-episode care compared with staged procedures. Few studies have investigated clinical outcomes after unilateral vs bilateral venous ablation procedures or between staged and concurrent bilateral procedures. Here, we report data from the Vascular Quality Initiative regarding truncal venous ablation for chronic venous insufficiency.
Methods:
Using data from the Vascular Quality Initiative, we investigated immediate postoperative as well as long-term clinical and patient-reported outcomes of patients undergoing unilateral vs bilateral truncal endovenous ablation from 2015 to 2019. We further investigated outcomes between staged bilateral and concurrent bilateral ablations. Preprocedural and postprocedural comparisons were performed using t-test, χ2 test, or their nonparametric counterpart when appropriate. Multivariable ordinal logistic regression was performed on ordinal outcome variables.
Results:
A total of 5029 patients were included, of whom 3782 (75.2%) underwent unilateral procedures. Median follow-up was 227 days (interquartile range [IQR], 55–788 days). Unilateral patients were less likely to be female (67.0% vs 70.3%; P = .031) and white (86.3% vs 91.2%; P < .001) and had lower body mass index (30.3 ± 7.3 kg/m2 vs 31.8 ± 7.6 kg/m2; P < .001) compared with patients undergoing bilateral procedures. In addition, unilateral patients had fewer prior varicose vein treatments (23.0% vs 15.7%; P < .001) and had higher median preprocedural Venous Clinical Severity Score (VCSS; 8 [IQR, 6–10] vs 7 [IQR, 5.5–9]; P < .001). No difference was seen in complications (6.9% vs 8.2%; P = .292), and systemic complications were rare in both groups. No difference was seen in VCSS improvement after treatment (median, 3 [IQR, 1–6] for unilateral; median, 3 [IQR 1–5] for bilateral; P = .055). In comparing staged with concurrent bilateral procedures, there was no difference in overall complications (7.5% vs 12.2%; P = .144). Staged bilateral patients were older (56.9 ± 13.3 years vs 54.2 ± 12.9 years; P = .002), less likely to have had prior varicose vein treatment (14.3% vs 19.8%; P = .020), and more likely to be therapeutically anticoagulated (10.8% vs 6.5%; P = .028) compared with concurrent bilateral patients. Staged patients also have higher preprocedural VCSS compared with concurrent patients (median, 8 [IQR, 6–10] vs 7 [IQR, 5.5–9]; P < .001). In multivariable analysis, there was no difference in the likelihood of VCSS improvement for concurrent compared with staged procedures (odds ratio, 0.70; 95% confidence interval, 0.40–1.24; P = .226).
Conclusions:
Concurrent bilateral truncal endovenous ablation can be performed safely without increased morbidity compared with staged bilateral or unilateral ablations.
Keywords: Venous insufficiency, Varicose veins, Chronic venous disease, Endovenous ablation, Unilateral, Bilateral
Venous insufficiency is a common disease affecting approximately 30% of the population, with a large proportion suffering from bilateral disease.1,2 The long-term effects of venous insufficiency include venous stasis ulcers, which affect up to 1% of the population, as well as pain, skin changes, and swelling.3 This results in decreased quality of life and missed work days with direct medical expenditures in the United States costing an estimated $1 billion annually.4–6 Minimally invasive endovenous treatment has evolved substantially since the first use of endovenous radiofrequency ablation in 1999. Multiple studies have demonstrated the superiority in postoperative outcomes including faster recovery times, decreased postoperative pain, and overall increased quality of life scores after endovenous ablation compared with venous ligation and stripping.7 Shorter recoveries improved the practicality of concurrently performed bilateral procedures rather than staged unilateral procedures for bilateral disease, which one study has shown to be the preferred method among patients when surveyed.8
Few studies have evaluated outcomes comparing unilateral vs bilateral venous ablation. Those available are limited to outcomes measuring efficacy of treatment but lack information about complications and patient-reported quality of life measures.9,10 In addition, these studies are limited by sample size and inadequate length of follow-up. Limited data are available regarding outcomes after staged bilateral venous ablation compared with concurrent bilateral venous ablation procedures.
In this study, we investigated the hypothesis that patients undergoing unilateral truncal endovenous ablation have similar morbidity and patient-reported outcomes compared with patients undergoing bilateral truncal endovenous ablation. Furthermore, we hypothesized that patients who undergo staged bilateral truncal endovenous ablation have similar morbidity and patient-reported outcomes compared with patients undergoing concurrent bilateral truncal endovenous ablation for the treatment of chronic venous insufficiency in the Vascular Quality Initiative (VQI) Varicose Vein Registry (VVR).
METHODS
VQI VVR.
The VQI VVR is a prospectively maintained national surgical registry maintained by the Society for Vascular Surgery and is composed of a collaborative network of vascular specialists from a variety of specialties with a purpose of improving the quality and safety of vascular surgical care. The greater VQI maintains a designation as a Patient Safety Organization by the Agency for Healthcare Research and Quality and contains data from patients undergoing a variety of surgical procedures in the United States.11 The VVR was launched in 2015 as the successor to the original varicose vein registry, the American Venous Registry, launched by the American Venous Forum. It contains data for patients undergoing percutaneous or open superficial venous procedures. Cases are entered, and follow-up includes one early follow-up (0–3 months) and one late follow-up (>3 months after the procedure). At initial reporting, Clinical, Etiology, Anatomy, and Pathophysiology (CEAP) class and Venous Clinical Severity Score (VCSS) are recorded for both legs. Follow-up reporting includes the treated leg’s CEAP class and VCSS along with outcomes.12
Inclusion criteria included patients who underwent procedures to ablate truncal veins (including the great saphenous vein, anterior accessory great saphenous vein, superficial accessory great saphenous vein, small saphenous vein, or other truncal vein) using radiofrequency or laser ablation in the lower extremity between 2015 and 2019. Patients who underwent procedures from 2014 were excluded as these were entered into the registry retrospectively. Furthermore, all patients included in the VVR undergo at least one follow-up appointment, at which time they are assessed for the presence or absence of postoperative complications, VCSS, CEAP class for each leg, and patient-reported outcome measures. A total of 12,915 patients are included in the VVR for the years studied. Of these, 5080 patients met the inclusion criteria and were included in the analysis. Patients who underwent concomitant sclerotherapy or phlebectomy or who underwent treatment of nontruncal veins were also excluded from the initial analysis to minimize confounding related to heterogeneity of procedure type between legs. A subsequent sensitivity analysis that mirrored our initial analytic plan but including patients who underwent concurrent phlebectomy or sclerotherapy was completed. These results are shown in the Supplementary Tables (online only).
Patients’ demographics and diagnostic, preoperative, intraoperative, and postoperative data were collected prospectively by trained support staff at each center.12–14 There are webinars to train data managers, online support staff to field questions about all the variables, and strong data definitions. Entry of consecutive procedures by each participating center is ensured by annual audit against hospital claims data submitted by each center. VQI data forms contain error tracking software to prevent erroneous entry. Data that are entered are periodically checked for statistical aberration. Data that appear to be in error are then audited within centers to ensure accuracy and completeness. The University of Michigan Institutional Review Board waived the need for review, and informed consent of the patient was waived for this exempt analysis.
Patients also complete a quality of life survey before the procedure and then at follow-up. This survey defines seven different parameters, including leg heaviness, achiness, swelling, throbbing, itching, appearance, and work impact, and asks the participant to grade each parameter on an ordinal scale (0, none of the time; and 5, all of the time). Each patient-reported outcome was rated on a scale of 0 to 4 or 5, depending on the specific outcome:
For heaviness, achiness, swelling, throbbing, and itching, the scale was as follows: 0, none of the time; 1, a little of the time; 2, some of the time; 3, a good bit of the time; 4, most of the time; and 5, all of the time.
For appearance, the scale was as follows: 0, not at all noticeable; 1, slightly noticeable; 2, moderately noticeable; 3, very noticeable; and 4, extremely noticeable.
For impact on work/activity, the scale was as follows: 0, none; 1, symptoms but full work/activity; 2, mildly reduced work/activity; 3, moderately reduced work/activity; 4, severely reduced work/activity; and 5, unable to do work/activity.
The total possible scores range from 0 to 34.
This patient-reported outcomes assessment instrument resembles the HASTI instrument, which has been validated previously, with the addition of the impact on work/activity questions.12–16 VCSS for patients undergoing bilateral procedures represents the average of the two legs. Preoperative CEAP class for patients undergoing bilateral procedures was calculated as the maximum value of the two legs in the period before the procedure for either leg, and likewise the final CEAP class was calculated as the maximum of the two legs after the final procedure for either leg. This method of determining CEAP class was used in both the univariable and multivariable analysis.
Data regarding the following procedure-specific postoperative outcomes are separately recorded for each patient: bleeding requiring intervention, skin blistering, deep venous thrombosis (DVT), hematoma, paresthesia, skin pigmentation, superficial phlebitis, induced ulcer formation, wound infection, and proximal thrombus extension.
Data regarding the following systemic complications are also collected: mild allergic reaction, severe allergic reaction, migraine, visual disturbance, cough/chest tightness, systemic infection, pulmonary embolism, transient ischemic attack, cerebrovascular accident, or death. A composite end point of any of these systemic complications occurred in a total of 11 patients in the entire cohort. Because of small cell size for all these comparisons, no statistical analysis was completed.
Statistical analysis.
Patients’ demographics as well as procedural and clinical characteristics are described using summary statistics. Categorical variables are presented as frequency counts with percentages, and continuous variables are presented as mean ± standard deviation or median with interquartile range (IQR). Student t-tests and χ2 tests or their nonparametric counterparts when the underlying distribution was non-normal were used to compare continuous and categorical variables, respectively. For the multivariable analyses, covariates significant at the P < .30 level in the univariate analysis were included in a multivariable logistic regression model. The α level was set at .05 unless otherwise noted. Stata version 16 (StataCorp LLC, College Station, Tex) was used for all analyses.
RESULTS
Characteristics of patients undergoing unilateral vs bilateral procedures.
The VVR contains information about month and year of surgery but does not contain more granular surgical timing information. Within this context, patients undergoing bilateral procedures had a median length of time between treatment of the first leg and treatment of the second leg of 1 month (IQR, 0–3 months). Patients undergoing unilateral truncal endovenous ablation were less likely to be female (67.0% vs 70.3%; P = .031) and white (86.3% vs 91.2%; P < .001) compared with patients undergoing bilateral truncal endovenous ablation (Table I). No statistical difference was seen in length of follow-up (226.5 days [IQR, 47–785 days] vs 227 days [IQR 97–799 days]; P = .051). In addition, patients undergoing unilateral procedures had lower mean body mass index (30.3 ± 7.3 kg/m2 vs 31.8 ± 7.6 kg/m2; P < .001) and higher rates of prior DVT (7.1% vs 4.8%; P = .004) and were more likely to have undergone prior varicose vein treatment (23.0% vs 15.7%; P < .001). No difference was seen in age, number of pregnancies, or proportion receiving anticoagulation between these two groups. The results from the sensitivity analysis are included in Supplementary Table I (online only) and mirror the results for the primary analysis with the exception that patients undergoing unilateral procedures had shorter median follow-up compared with those undergoing bilateral procedures.
Table I.
Univariable comparison of characteristics of patients undergoing unilateral vs bilateral and staged bilateral vs concurrent bilateral truncal endovenous ablation without additional sclerotherapy or phlebectomy
| Unilateral (n = 3782) | Bilateral (n = 1247) | P value | |
|---|---|---|---|
| Patient characteristic | |||
| Age, years | 56.7 (13.9) | 56.2 (13.2) | .280 |
| Sex, female | 2532 (67.0) | 876 (70.3) | .031 |
| Race, white | 2621 (86.3) | 1014 (91.2) | <.001 |
| Length of follow-up, days | 226.5 (47–785) | 227 (97–799) | .051 |
| BMI, kg/m2 | 30.3 (7.3) | 31.8 (7.6) | <.001 |
| Prior VV treatment | 868 (23.0) | 195 (15.7) | <.001 |
| History of DVT | 269 (7.1) | 60 (4.8) | .004 |
| Receiving anticoagulation | 361 (9.6) | 121 (9.7) | .859 |
| No. of pregnancies | 2 (1–3) | 2 (1–3) | .164 |
| Preprocedural CEAP class | <.001 | ||
| C2 | 893 (24.1) | 216 (20.5) | |
| C3 | 1522 (41.0) | 530 (50.3) | |
| C4 | 862 (23.2) | 249 (23.7) | |
| C5 | 119 (3.2) | 23 (2.2) | |
| C6 | 313 (8.4) | 35 (3.3) | |
| Staged (n = 939) | Concurrent (n = 308) | P value | |
| Patient characteristic | |||
| Age, years | 56.9 (13.3) | 54.2 (12.9) | .002 |
| Sex, female | 658 (70.1) | 218 (70.8) | .814 |
| Race, white | 733 (90.3) | 281 (93.7) | .076 |
| Length of follow-up, days | 364 (68–898) | 124.5 (99–236.5) | <.001 |
| BMI, kg/m2 | 31.7 (7.5) | 32.0 (7.8) | .553 |
| Prior VV treatment | 134 (14.3) | 61 (19.8) | .020 |
| History of DVT | 43 (4.6) | 17 (5.2) | .511 |
| Receiving anticoagulation | 101 (10.8) | 20 (6.5) | .028 |
| No. of pregnancies | 2 (1–3) | 2 (1–3) | .966 |
| Preprocedural CEAP class | .001 | ||
| C2 | 138 (17.5) | 78 (29.7) | |
| C3 | 410 (51.9) | 120 (45.6) | |
| C4 | 200 (25.3) | 49 (18.6) | |
| C5 | 17 (2.2) | 6 (2.3) | |
| C6 | 25 (3.2) | 10 (3.8) |
BMI, Body mass index; CEAP, Clinical, Etiology, Anatomy, and Pathophysiology; DVT, deep venous thrombosis; VV, varicose vein.
Categorical variables are presented as number (%). Continuous variables are presented as mean (standard deviation) or median (interquartile range). CEAP class represents the maximum of the two legs for patients undergoing bilateral procedures.
Characteristics of patients undergoing staged vs concurrent bilateral procedures.
Of patients undergoing bilateral truncal venous ablation, 939 were staged and 308 were performed concomitantly (Table I). Patients undergoing concurrent procedures were found to be younger (mean age, 54.2 ± 12.9 years vs 56.9 ± 13.3 years; P = .002) and had shorter follow-up (124.5 days [IQR, 99–236.5 days] vs 364 days [IQR, 68–898 days]; P < .001) compared with patients who underwent staged bilateral procedures. Patients treated concurrently were also more likely to have had prior varicose vein treatment (19.8% vs 14.3%; P = .020) and less likely to be receiving therapeutic anticoagulation (6.5% vs 10.8%; P = .028) compared with those who underwent staged procedures. The results from the sensitivity analysis are included in Supplementary Table I (online only) and mirror the results for the primary analysis.
Systemic and procedure-specific complications of patients undergoing unilateral vs bilateral procedures.
Systemic complications, such as transient ischemic attack, migraine, mild or severe allergic reactions, visual disturbances, pulmonary embolism, stroke, or death, were rare for all subgroups (data not shown). The overall rate of reported systemic complication was 0.15%. No differences were seen in any procedure-specific complication investigated between unilateral and bilateral procedures, including postoperative DVT, bleeding requiring reintervention, skin blistering, hematoma, paresthesia, pigmentation, superficial phlebitis, wound infection, or proximal thrombus extension (Table II). Results from the sensitivity analysis included in Supplementary Table II (online only) revealed a similar pattern of complications after inclusion of sclerotherapy and phlebectomy. The difference seen between unilateral and bilateral rates of DVT reached statistical significance (0.9% vs 1.7%; P = .017), whereas no other differences were seen in complications between unilateral and bilateral groups.
Table II.
Procedure-specific complications for patients undergoing unilateral vs bilateral and staged bilateral vs concurrent bilateral procedures
| Procedure-specific complications | Unilateral (n = 3782), No. (%) | Bilateral (n = 1247), No. (%) | P value |
|---|---|---|---|
| Any complication | 141 (6.9) | 52 (8.2) | .292 |
| DVT | 11 (0.5) | 8 (1.3) | .099 |
| Bleeding requiring intervention | 2 (0.1) | 0 | |
| Skin blistering | 8 (0.4) | 1 (0.2) | .695 |
| Hematoma | 6 (0.3) | 3 (0.5) | .452 |
| Paresthesia | 31 (1.5) | 8 (1.3) | .709 |
| Pigmentation | 18 (0.9) | 3 (0.5) | .441 |
| Superficial phlebitis | 24 (1.2) | 13 (2.0) | .119 |
| Induced ulcer requiring intervention | 0 | 0 | |
| Wound infection | 9 (0.4) | 3 (0.5) | 1.000 |
| Proximal thrombus extension | 38 (1.9) | 16 (2.5) | .332 |
| Procedure-specific complications | Staged (n = 939), No. (%) | Concurrent (n = 308), No. (%) | P value |
| Any complication | 41 (7.5) | 11 (12.2) | .144 |
| DVT | 7 (1.3) | 1 (1.1) | 1.000 |
| Bleeding requiring intervention | 0 | 0 | |
| Skin blistering | 1 (0.2) | 0 | 1.000 |
| Hematoma | 1 (0.2) | 2 (2.2) | .054 |
| Paresthesia | 6 (1.1) | 2 (2.2) | .315 |
| Pigmentation | 3 (0.6) | 0 | 1.000 |
| Superficial phlebitis | 9 (1.7) | 4 (4.4) | .097 |
| Induced ulcer requiring intervention | 0 | 0 | |
| Wound infection | 2 (0.4) | 1 (1.1) | .367 |
| Proximal thrombus extension | 13 (2.4) | 3 (3.3) | .484 |
DVT, Deep venous thrombosis.
Systemic and procedure-specific complications of patients undergoing staged vs concurrent bilateral procedures.
The findings for the comparison of staged with concurrent bilateral truncal endovenous ablation procedures were similar to those detailed for unilateral vs bilateral in that there were no significant differences in reported rates of systemic or procedure-specific complications, specifically DVT, bleeding requiring intervention, skin blistering, hematoma, paresthesia, skin pigmentation, superficial phlebitis, induction of ulcer requiring intervention, wound infection, or proximal thrombus extension, regardless of the timing of the procedures as also shown in Table II. Results from the sensitivity analysis included in Supplementary Table II (online only) revealed a similar pattern of complications after inclusion of sclerotherapy and phlebectomy with the exception of increased rates of bleeding requiring reintervention (0% vs 0.8%; P = .031) as well as hematoma (0.4% vs 4.3%; P < .001). No difference was seen between reported rates of other complications investigated.
Procedural and patient-reported outcomes for patients undergoing unilateral vs bilateral procedures.
Clinical severity was compared using the VCSS as previously described and subsequently validated as well as a separate quality of life questionnaire as described in the Methods section.17–19 Patients undergoing unilateral procedures overall were more likely to have advanced disease per clinical class of CEAP (P = .001) and higher preprocedural VCSS (median, 8 [IQR, 6–10] vs 7 [IQR, 5.5–9]; P < .001) compared with those who underwent bilateral procedures. This difference in VCSS, however, was no longer significant after treatment (postprocedural median VCSS, 4 [IQR, 2–7] for unilateral patients and 4.5 [IQR, 2–6] for bilateral patients; P = .381). Total symptoms according to the quality of life survey were no different preprocedurally (median, 14 [IQR, 10–19] for unilateral; median, 14 [IQR, 10–18.5] for bilateral; P = .443) or postprocedurally (median, 4 [IQR, 1–9] for unilateral; median, 4 [IQR, 1–7.5] for bilateral; P = .086). Furthermore, no difference was seen between unilateral and bilateral patients in the magnitude of change in total symptom score (median, 8 [IQR, 4–13] for unilateral; median, 8.5 [IQR, 5–13] for bilateral; P = .072). Table III provides a summary of these comparisons as well as a comparison for individual symptoms.
Table III.
Comparison of patient-reported outcomes in unilateral vs bilateral procedures
| Unilateral (n = 3826) | Bilateral (n = 1254) | P value | |
|---|---|---|---|
| VCSS | |||
| Preprocedural | 8 (6–10) | 7 (5.5–9) | <.001 |
| Postprocedural | 4 (2–7) | 4.5 (2–6.5) | .414 |
| Change | 3 (1–6) | 3 (1–5) | .014 |
| Preprocedural symptoms | |||
| Total | 14 (10–19) | 14 (10–18.5) | .443 |
| Heaviness | 2 (1–3) | 2 (1–3) | .834 |
| Achiness | 3 (2–4) | 2 (1.5–3.5) | .008 |
| Swelling | 2 (1–4) | 2 (1–3.5) | .845 |
| Throbbing | 2 (0–3 | 2 (0.5–2.5) | .536 |
| Itching | 1 (0–2) | 1 (0–2) | .269 |
| Appearance | 3 (2–3) | 2 (1.5–3) | <.001 |
| Impact on work | 2 (1–3) | 2 (1–3) | .925 |
| Postprocedural symptoms | |||
| Total | 4 (1–9) | 4 (1–7.5) | .086 |
| Heaviness | 0 (0–1) | 0 (0–1) | .604 |
| Achiness | 1 (0–2) | 0.5 (0–1.5) | .423 |
| Swelling | 0 (0–2) | 0.5 (0–1.5) | .845 |
| Throbbing | 0 (0–1) | 0 (0–1) | .239 |
| Itching | 0 (0–1) | 0 (0–1) | .010 |
| Appearance | 1 (0–2) | 1 (0–2) | .008 |
| Impact on work | 0 (0–1) | 0 (0–1) | .129 |
| Change in symptoms (postprocedural-preprocedural) | |||
| Total | 8 (4–13) | 8.5 (5–13) | .072 |
| Heaviness | 1 (0–2) | 1.5 (0–2.5) | .124 |
| Achiness | 2 (0–3) | 1.5 (0.5–2.5) | .682 |
| Swelling | 1 (0–2) | 1.5 (0.5–2.5) | .004 |
| Throbbing | 1 (0–2) | 1 (0–2) | .029 |
| Itching | 0 (0–2) | 0.5 (0–1.5) | .176 |
| Appearance | 1 (0–2) | 1 (0–2) | .161 |
| Impact on work | 1 (0–2) | 1 (0–2) | <.001 |
VCSS, Venous Clinical Severity Score.
Values are reported as median (interquartile range).
Procedural and patient-reported outcomes for patients undergoing staged vs concurrent bilateral procedures.
Patients undergoing staged bilateral procedures had more severe disease overall by CEAP class compared with patients who underwent concurrent bilateral procedures (P = .002; Table I). Median preprocedural VCSS was higher in the staged bilateral patients (8 [IQR, 6–9.75]) compared with patients undergoing concurrent procedures (6.5 [IQR, 5.5–8]; P < .001). VCSS became equivalent after treatment (median, 4.5 [IQR, 2–6.5] for staged vs 4.5 [IQR, 2.5–6] for bilateral; P = .873). Symptoms were similarly worse overall in the preprocedure period for patients undergoing staged bilateral procedures (median, 14 [IQR, 10–19]) compared with those undergoing concurrent procedures (median, 12 [IQR, 8.5–16.5]; P < .001). This relationship was opposite that seen in the postprocedural period, with staged patients having better total symptom scores compared with patients undergoing concurrent procedures (median, 3.5 [IQR, 1–7.5] vs 5 [IQR, 2–8]; P = .001). This resulted in a median change in total symptom score of 10 (IQR, 6–14) for patients undergoing staged bilateral procedures compared with 6 (IQR, 2–10) for patients undergoing concurrent bilateral procedures (P < .001). Further comparisons of individual symptoms are shown in Table IV. Differences for patient-reported outcomes with the inclusion of patients undergoing sclerotherapy or phlebectomy are included in Supplementary Tables III and IV (online only).
Table IV.
Comparison of clinical classification and patient-reported outcomes in staged vs concurrent bilateral procedures
| Staged (n = 943) | Concurrent (n = 311) | P value | |
|---|---|---|---|
| VCSS | |||
| Preprocedural | 8 (6–9.75) | 6.5 (5–8) | <.001 |
| Postprocedural | 4.5 (2–6.5) | 4.5 (2.5–6) | .873 |
| Change | 3.5 (1.5–5.5) | 2 (0–4) | <.001 |
| Preprocedural symptoms | |||
| Total | 14 (10–19) | 12 (8.5–16.5) | <.001 |
| Heaviness | 2 (1–3.5) | 2 (0.5–3) | <.001 |
| Achiness | 2.5 (2–3.5) | 2 (1–3) | <.001 |
| Swelling | 2.5 (1.5–2.5) | 2 (1–3) | <.001 |
| Throbbing | 2 (0.5–2.5) | 1.5 (0–2) | .014 |
| Itching | 1 (0–2) | 1 (0–2) | .559 |
| Appearance | 2 (1.5–3) | 2.5 (1.5–3) | .031 |
| Impact on work | 2 (1–3) | 1 (1–2) | <.001 |
| Postprocedural symptoms | |||
| Total | 3.5 (1–7.5) | 5 (2–8) | .001 |
| Heaviness | 0 (0–1) | 0 (0–1.5) | .050 |
| Achiness | 0.5 (0–1.5) | 1 (0–1.5) | .004 |
| Swelling | 0.5 (0–1.5) | 0.5 (0–1.5) | .594 |
| Throbbing | 0 (0–0.5) | 0 (0–1) | .100 |
| Itching | 0 (0–0.5) | 0 (0–1) | .012 |
| Appearance | 1 (0–1.5) | 1 (0–2) | .003 |
| Impact on work | 0 (0–1) | 0 (0–1) | .380 |
| Change in symptoms (postprocedural-preprocedural) | |||
| Total | 10 (6–14) | 6 (2–10) | <.001 |
| Heaviness | 2 (0.5–2.5) | 1 (0–2) | <.001 |
| Achiness | 1.5 (1–3) | 1 (0–2) | <.001 |
| Swelling | 1.75 (0.5–2.5) | 1 (0–2) | <.001 |
| Throbbing | 1 (0–2) | 1 (0–2) | <.001 |
| Itching | 0.5 (0–2) | 0 (0–1) | .010 |
| Appearance | 1 (0–2) | 1 (0–2) | .463 |
| Impact on work | 1 (0.5–2.5) | 1 (0–1) | <.001 |
VCSS, Venous Clinical Severity Score.
Values are reported as median (interquartile range).
Multivariable logistic regression.
To control for potential confounding, a multivariable logistic regression model was used to compare the likelihood of improvement of VCSS between staged and concurrent bilateral truncal endovenous ablation with the following covariates: year of surgery, age, sex, body mass index, history of pregnancies, race, prior varicose vein treatment, prior DVT, use of anticoagulation preoperatively, preoperative CEAP class, and preoperative VCSS. After adjustment, no difference was seen in odds of VCSS improvement of patients who underwent concurrent bilateral procedures compared with staged bilateral procedures (odds ratio, 0.70; 95% confidence interval [CI], 0.40–1.24, P = .226). Female patients had 5.31-fold higher odds of improvement in VCSS compared with male patients (95% CI, 1.52–18.49; P = .009). In addition, higher preoperative VCSS was associated with an increased odds of reporting an improvement in VCSS (odds ratio, 1.36; 95% CI, 1.18–1.56, per point), as shown in Table V. The results of the multivariable analysis including patients who underwent phlebectomy or sclerotherapy are shown in Supplementary Table V (online only). Several differences were found, including significant effects for the latest years of surgery, body mass index, nonwhite race, and preoperative CEAP class. Concurrent procedures continued to show no statistically significant effect.
Table V.
Multivariable analysis for predictors of improvement in Venous Clinical Severity Score (VCSS) among patients undergoing bilateral procedures
| Characteristics | OR | 95% CI | P value |
|---|---|---|---|
| Concurrent bilateral procedures | 0.70 | 0.40–1.24 | .226 |
| Year of surgery | |||
| 2016 | 0.81 | 0.37–1.77 | .595 |
| 2017 | 1.04 | 0.47–2.30 | .920 |
| 2018 | 1.32 | 0.53–3.30 | .550 |
| 2019 | 1.63 | 0.17–15.58 | .673 |
| Age (per year) | 1.00 | 0.98–1.02 | .854 |
| BMI (per point) | 0.96 | 0.93–1.00 | .054 |
| Female | 5.31 | 1.52–18.49 | .009 |
| Prior pregnancy | 0.29 | 0.08–1.01 | .051 |
| Nonwhite race | 2.10 | 0.59–7.43 | .251 |
| Prior varicose vein procedure | 0.73 | 0.37–1.45 | .374 |
| History of DVT | 0.89 | 0.26–3.05 | .861 |
| Preoperative VCSS (per point) | 1.36 | 1.18–1.56 | <.001 |
| Preoperative CEAP class | |||
| C3 | 1.06 | 0.53–2.11 | .870 |
| C4 | 0.82 | 0.33–2.07 | .676 |
| C5 | 0.52 | 0.07–3.98 | .528 |
| C6 | 0.12 | 0.02–0.93 | .042 |
BMI, Body mass index; CEAP, Clinical, Etiology, Anatomy, and Pathophysiology; CI, confidence interval; DVT, deep venous thrombosis; OR, odds ratio.
DISCUSSION
In this analysis of the VQI VVR data, lower extremity truncal endovenous ablation resulted in low rates of both major systemic complications and procedure-specific complications and also resulted in significant overall improvement in both patient-reported outcomes and objective clinical classification of disease severity (VCSS). The main findings of this study include the following: in comparing the impact of the procedure on change in VCSS, no difference was seen for patients undergoing unilateral compared with bilateral therapy; those treated for bilateral disease in a single episode had no significant difference in systemic or procedure-specific morbidity compared with patients undergoing unilateral treatment; no difference was seen in terms of VCSS improvement of patients undergoing bilateral staged compared with concurrent therapy; and after adjustment for demographics and preoperative characteristics, female patients had a higher odds of improvement in VCSS than male patients.
Importantly, the results from this study should allay concerns that some surgeons have about an increased risk of complications for concurrent procedures. Specifically, we found no association with bilateral procedures and risk of complications, confirming the findings from other smaller studies.10,20 Moreover, we found that objective clinical assessment by VCSS was similar between groups. Patient-reported symptoms showed a larger magnitude of improvement after staged procedures compared with concurrent bilateral procedures. This is likely to be multifactorial, combining a component of patient expectations in improvement as well as possibly a true difference in symptom improvement that has not yet been studied.
Our data suggest that women appear to achieve greater improvement in VCSS compared with men. Others have reported improved occlusion rates with endovenous therapy in women compared with men, perhaps providing an explanation for this finding.19 A more substantial improvement in total symptom score as well as in all individual symptoms except for appearance was seen for patients who underwent staged bilateral procedures compared with patients who underwent concurrent bilateral procedures.
Several factors limit the conclusions of this study. Fore-most is the possibility of uncontrolled confounding. The VVR is a procedural data set and therefore does not contain information for patients who, for one reason or another, did not undergo treatment. Nor does the VQI VVR contain information about the reasons that bilateral procedures may have been performed in a staged or concurrent fashion. This may bias the estimates in the case that patients at higher risk of complications were deemed not to be surgical candidates and therefore not included in this analysis. Furthermore, this study represents a retrospective analysis of a prospectively collected database, which may bias the results by differential selection. The timing of staged bilateral procedures is variable in clinical practice, and it is unclear how the time between surgical procedures will affect outcomes studied here. The VVR does not contain information about the exact date and time of a procedure, but it does contain information about the year and month of surgery. When analyzed this way, the median length of time between the first and second procedures for those undergoing staged procedures was 1 month, with the 75th percentile being 2 months. This suggests that the majority of patients included in this study underwent a staged procedure expeditiously rather than waiting for many months or even years.
Whereas no assessment of technical success is made in the VVR, previous studies have suggested that technical success is achieved in approximately 95% of patients undergoing endovenous ablation of truncal veins.21 We also would not expect technical success rates to differ substantially by timing of procedure. For these reasons, technical success is likely to be a minor contributor to any error in effect size estimate. Recanalization of truncal veins after ablation also represents a pathway for differences in outcomes following these procedures. The VVR collects data regarding recanalization, but there is no requirement for a surgeon to assess for this radiographically. Rates of detected recanalization were low (0.18% overall), but given the lack of systematic assessment, there may be undetected recanalizations that could be differentially dispersed among the groups studied. Follow-up was found to be different between those undergoing staged bilateral procedures and those undergoing concurrent bilateral procedures. We found no effect of including follow-up length in any of our multivariable models. We believe that the difference seen in the univariable analysis represents a statistically significant but not clinically significant difference. Finally, we purposefully excluded patients undergoing treatment of nontruncal veins as well as those undergoing alternative treatment strategies other than endovenous ablation, which may limit the generalizability of these findings to other populations or varicose vein treatment modalities such as phlebectomy, sclerosis, or other nonthermal nontumescent techniques. However, our sensitivity analysis results, which included patients who underwent other concurrent procedures including sclerotherapy and phlebectomy, were comparable to the primary analysis. Higher rates of hematoma formation were seen for patients undergoing concurrent bilateral procedures compared with those undergoing staged bilateral procedures. This result contrasted with the result from the primary analysis, which found no statistical difference; however, we believe this represents an underpowered comparison rather than a true lack of difference. The VVR does represent a national sample of patients undergoing treatment of venous disease, and our results therefore represent the most comprehensive assessment of patient-reported outcomes among patients undergoing unilateral and bilateral truncal endovenous ablation to date. Despite the breadth of patients included in the VVR, this study probably includes a minority of the total patients undergoing endovenous procedures in the United States. There may be biases in the way that centers included in the VVR complete bilateral procedures, but previous studies of patients included in the VVR have not suggested significantly different outcomes compared with patients outside the VVR.12–14 Furthermore, the VVR represents the only database available to investigate this outcome outside the context of a clinical trial, which would be prohibitively expensive, or a single-center study, which would suffer from the same or greater biases present within the VVR. Despite these limitations, the question of outcomes after unilateral and bilateral procedures remains a clinically important question that is best answered using the VQI VVR.
CONCLUSIONS
Based on a large national sample, bilateral concurrent thermal endovenous treatment of axial reflux appears to be safe without an increase in periprocedural complications. Further studies should first prospectively confirm our findings regarding symptomatic improvement and complication rates, then focus on comparing costs of staged and concurrent procedures. Investigation into the difference seen in patient-reported symptom improvement between staged and concurrent bilateral procedures represents an important future study topic. Given that some data suggest that patients are much more likely to prefer a single episode of care for bilateral venous disease, concurrent bilateral truncal endovenous ablation represents a safe and viable treatment option for patients with symptomatic bilateral chronic venous insufficiency.8
Supplementary Material
ARTICLE HIGHLIGHTS.
Type of Research: Retrospective analysis of prospectively collected registry data (Vascular Quality Initiative)
Key Findings: Among 5029 patients with chronic venous disease, there was no difference in complications for patients treated unilaterally with truncal endovenous ablation compared with bilaterally (6.9% vs 8.2%) and similarly no difference for patients treated concurrently for bilateral disease compared with sequentially (12.2% vs 7.5%).
Take Home Message: Concurrent bilateral truncal endovenous ablation can be performed safely without increased morbidity compared with staged or unilateral ablations.
Acknowledgments
The National Institutes of Health funded this work through NIH 5T32HS000053-28, which provides salary support for C.S.B.
Footnotes
Author conflict of interest: A.T.O. is the principal investigator for a contract with Medtronic on device development for the treatment of deep venous thrombosis. It is not relevant for the current study.
The editors and reviewers of this article have no relevant financial relationships to disclose per the Journal policy that requires reviewers to decline review of any manuscript for which they may have a conflict of interest.
Presented as an oral presentation at the Thirty-second Annual Meeting of the American Venous Forum, Amelia Island, Fla, March 3–6, 2020.
Additional material for this article may be found online at www.jvsvenous.org.
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