Abstract
Objectives
To portray the initial experience at a public health center of the Federal District of Brazil in the treatment of chronic venous insufficiency with ultrasound-guided foam sclerotherapy in patients in advanced stages of the disease.
Method
Eighty-seven reports of patients in C5 and C6 stages, according to CEAP classification, were evaluated for clinical improvements, ulcer-healing rates, and complications of ultrasound-guided foam sclerotherapy. McNemar test was used for statistical analysis with the level of significance set at 5% (P-value, 0.05).
Results
The results showed high rates of ulcer healing (85%) and significant improvement of symptoms after treatment, such as pain, heaviness, fatigue, burning, paresthesia, and itching (P < 0.0001).
Conclusions
An outpatient, low-cost and high-resolution technique, without the need for hospitalization and use of the operating room showed to be a safe and effective alternative for the treatment of varicose disease associated with severe chronic venous insufficiency.
Introduction
Varicose veins of lower limbs are a serious public health problem, both due to their high prevalence and due to their socioeconomic impact on individual’s life and for public health managers. This condition affects nearly 20% of the adult population in Western countries, 1 with 3.6% of these cases being related to an active or healed ulcer. 2 According to Brazilian official data, it accounts for the 14th leading cause of temporary absenteeism from work. 3 In addition, it was found that 21% of the 61,000 admissions for chronic venous insufficiency (CVI) in public and health insurance hospitals that occurred in 2000 were due to nonhealing ulcers.
With regard to the public expenses resulting from this type of disease, during the year 2004, the National Unified Health System allocated 43 million Brazilian reais for varicose vein surgeries. 4
In severe cases of CVI, in which there is the presence of trophic changes secondary to this disease, the definitive treatment of varicose veins with conventional surgical techniques tends to be replaced with palliative care and clinical measures such as postural drainage.
It is recommended that the optimal treatment for primary varicose veins of lower limbs should be little invasive; repeated whenever needed; without significant complications; effective in eliminating reflux points and reducing venous hypertension and inflammatory factors in the extremities; of low cost; with esthetic improvement and little need of absenting from work. 5 In this context, the treatment with ultrasound-guided polidocanol foam sclerotherapy meets these requirements. The use of sclerotherapy has been disseminated in many countries,6,7 being recommended in the management of patients with severe CVI. However, there are still few publications on the use of this technique in the Brazilian population. 8 Thus, this study aimed to evaluate the results of the implementation of the therapy with sclerotherapy using ultrasound-guided polidocanol foam as a routine practice for the treatment of patients with severe CVI.
Methods
A retrospective study was conducted to evaluate information obtained from the medical records of patients assisted at the Vascular Surgery outpatient clinic of a public hospital in the city of Brasília, Federal District of Brazil, from October 2011 to May 2013. The study selected medical records of patients above 18 years old presenting with CVI of lower limbs with clinical picture of nonhealing or healed ulcer at any phase of evolution. The analysis included only medical records presenting information related to the CEAP classification (clinical, etiologic, anatomical, and pathophysiologic) 9 and that reported pre and posttreatment symptoms. In addition, medical records should be related to patients who underwent the same sclerotherapy technique using ultrasound-guided polidocanol foam sclerotherapy performed by two vascular surgeons (FCN and GRA). Medical records with missing data about patient’s initial and final symptoms were excluded, as well as medical records of patients who, although meeting diagnostic and treatment criteria, had been treated by another vascular surgeon. Patients with recent deep vein thrombosis (DVT), a previous episode of DVT without recanalization in ultrasound evaluation, as well varicose veins without involvement of the saphenous and/or perforating veins, were also excluded. Medical records with reports of thrombophilia, active neoplasm or that is being followed up, referred lung disease, and peripheral artery insufficiency (ankle-arm index < 0.9) were also excluded. The research project was submitted and approved by the Research Ethics Committee (CAAE: 16376013.6.0000.5553).
Report of signs and symptoms
Medical records were searched for answers regarding pain, heaviness, fatigue, burning, paresthesia, and itching. According to the reports, patients were directly asked during clinical interview about the presence or absence of the symptom, without using a specific scale. Clinical signs (edema, ocher dermatitis, dermatofibrosis, and nonhealing or healed ulcer) were recorded by analyzing physical examinations performed during clinical evaluation.
The following variables were assessed: affected member, comorbidities, symptoms (pain, heaviness, fatigue, burning, paresthesia, and itching) and number of previous ulcers, diameter of nonhealing ulcers, and reflux origin (considering the saphenous veins: magna alone, magna and perforating veins, magna and small veins, small alone, small and perforating vein, or perforating vein alone). As for the procedure, the study analyzed the number of sessions and punctures, volume of foam applied, healing rate, and the impact of the treatment on previous symptoms.
Evaluations were performed by clinical interview, physical examination, and vascular ultrasound at at least 7 and 30 days and then at 3 months in standing position. All procedures and all subsequent evaluations were conducted by one of the authors, following a pattern of data collection.
Sclerotherapy technique
The selected medical records were related to patients who had their procedures performed at the outpatient clinic of the Vascular Surgery Unit, without the need for anesthesia. All patients were evaluated by color Doppler examination for the mapping of varicose veins and determination of reflux sources in the superficial venous system and also to rule out recent DVT or past event without recanalization. Reflux was defined as a reverse flow longer than 0.5 s assessed using color mapping and spectral analysis for saphenous vein and longer than 0.35 s for perforating veins, measured by Esaote™ MyLab 40 color ultrasound machine (Genoa, Italy) and induced by Valsalva maneuver and/or manual muscle compression distal to the position of the transducer. Patients were positioned in the lateral decubitus position ipsilateral to the saphenous vein to be treated in an attempt to facilitate the exposure of the path of the vein; in cases involving the treatment of the small saphenous vein, patients were positioned in the prone position, and in those involving perforating veins alone, they were positioned in the supine position, with limb rotation to allow for the exposure of the area of the perforating vein. Punctures were guided by ultrasound, using a Scalp (also known as Butterfly needle) 21, 23, and 25 gauge and/or Jelco 20, depending on the depth of the vein. They were performed in the affected saphenous veins (great or small) and in the varicose tributaries, or in varicose veins at at 3 cm of the perforating vein. It was decided to always perform at least one puncture in the affected saphenous trunk and a minimum of one puncture in the varicose tributaries, regardless of the depth of the vein. If there was the need for completing the treatment, the session was conducted with one or more punctures, as required in each case. Foam was produced by the mixture of 1 or 3% polidocanol with ambient air in a 1:4 ratio, depending on the caliber of the vein to be treated, according to medical assistant’s judgment. The procedure was performed using a three-way tap, connected to syringes with polidocanol and air, respectively—a technique described by Tessari. 7 The maximum total volume of foam injected in one session was 10 mL, which was performed under echographic view.
After the injection, patients were advised to remain at rest for 2–5 min, without moving the body and without performing the Valsalva maneuver, if there were no complaints. In situations in which a large volume of foam was echographically identified in the deep system, the patient was asked to perform maneuvers of plantar dorsiflexion to mobilize the foam. 10 Before treatment with foam sclerotherapy, all patients were subjected to compression therapy as the only therapeutic modality.
After the treatment with foam sclerotherapy, compression was achieved using 15–23 mmHg or 20–30 mmHg compression stockings, which were worn day and night for 7 days and taken off only for personal hygiene. From the 7th day onward, it was recommended to wear stockings only during the day.
Statistical analysis
Analyses were performed using the statistical software Statistical Package for Social Sciences (SPSS® version 20.0 for Windows®, SPSS Inc./IBM Group, Chicago, USA). The McNemar test was applied to compare the symptoms before and after treatment. To do so, answers about symptoms were categorized as follows: presence of initial pain, 1; absence of initial pain, 2; with pain improvement after treatment, 2; without pain improvement after treatment, 1. Statistical significance was set at 5% (two-tailed).
The present study followed the regulations established by the Declaration of Helsinki and was conducted according to the Good Practices in Clinical Research.
Results
A total of 254 medical records were evaluated, 87 of which met inclusion criteria. It was found that 34.5% (30/87) of medical records were related to patients classified as CEAP 5 and 65.5% (57/87) as CEAP 6; 72% (63/87) of the cases were female; subjects’ mean age was 53 years (27–79 years), and the lower left limb was the affected limb in 56% (49/87) of the sample. High blood pressure was the most frequent comorbidity, totaling 36% (32/87). Previous venous thrombosis was observed in 5% (4/87) of the medical records. Six patients had their lower limb immobilized prior to the onset of varicose veins, and the same value was found for thrombosis in a first-degree relative. A single ulcer was reported in 60% (52/87) of the patients, and the remainder reported two or more previous ulcers. The number of ulcers measured prior to the treatment was 82 (94%), with a median diameter of 10 mm, ranging from 0 (healed ulcers) to 200 mm.
Signs present on evaluation prior to treatment.
Symptoms present on evaluation prior to treatment.
CVI associated with reflux of great saphenous vein was the most frequent type of CVI, accounting for 52 cases (60%). Involvement of small saphenous vein was present in 11 patients, either alone or associated with great saphenous vein or with perforating veins.
More than a half of patients underwent a single session (58%) and treated with two or more punctures (95%), and the mean volume of foam was 13.5% per treatment. The mean number of treatment sessions was 1.6. The number of patients who underwent sclerotherapy with 3% polidocanol foam was 79 (91%), while four of them were treated with 1% polidocanol, and other four patients received both concentrations, in independent sessions.
The number of patients who had nonhealing ulcers at the beginning of the treatment was 57 (66%), and the healing rate was 85%. The rate of ulcers that remained healed in patients classified as CEAP 5 was 100%.
Complications after treatment.
Symptom resolution after treatment.
Furthermore, patients were asked to spontaneously attribute a value from 0 to 10 (in which 0 would correspond to no improvement in the clinical picture presented before treatment and 10 to the complete disappearance of the symptoms reported prior to treatment). Of the 87 patients in the sample, 77 (89%) decided to evaluate the result of their treatment. Nearly, 4% of the patients assigned a grade below 8 for the treatment, and 60% reported complete remission from the previous clinical picture after treatment, attributing grade 10 to the final result.
Discussion
It is important to evaluate the results of therapies implemented as routine practice for the treatment of severe CVI, since CVI secondary to varicose veins of lower limbs is a very frequent disease in vascular surgery outpatient clinics of Brazilian public hospitals. Surgical treatment of varicose veins using total or partial saphenectomy, with or without resection of collateral varicose veins, has been considered the most performed treatment for this disease. 11 Despite the investments of the Brazilian Ministry of Health for the performance of varicose veins surgeries, 12 Souza et al. 13 draw attention to the fact that this investment may not have benefited the most advanced cases of the chronic venous disease, favoring patients in the early stages of CVI. In face of the most advanced cases of disease, especially those associated with active ulcers, the choice for palliative care up to wound healing becomes very frequent, with surgery being performed later. However, in many cases, healing does not occur, and physical and social sequelae of the disease get much worse.14,15 Skin trophic changes resulting from the disease, such as dermatofibrosis and lipodermatosclerosis, are factors that make it difficult to perform the surgery.
In this context, sclerotherapy using ultrasound-guided foam sclerotherapy has a great potential to have a major role in the treatment of patients with severe CVI. It is a minimally invasive and low-cost procedure susceptible to repetition until the desired result is obtained, with symptomatic improvement capable of healing wounds and keeping them healed. 16
The Federal District of Brazil, through its Department of Health, is responsible for providing medical/hospital care for the population to the full extent, without the support of a supplementary private network in the treatment of CVI in any stage of the disease. Moreover, another singular aspect was noted: the geographical location of the Federal Capital makes it necessary for the Federal District to provide medical services to all surrounding areas of the city of Brasília, covering great part of the Midwestern region of the country.
Thus, in the Federal Capital, a significant number of patients with CVI seek for medical care, notably those in the advanced stages of the disease, which has a great impact on patient care, because the health system does not support the demand for conventional surgical treatment. Additionally, all the difficulties inherent to the treatment of this particular patient are also present in the reality of Vascular Surgery in the public services in Brasília and its satellite towns.
The initial experience in the Hospital Regional da Asa Norte, unit of the Health Care Department of the Federal District, in the treatment of severe CVI with echoguided foam sclerotherapy has shown excellent results, with healing rates of 85% for CEAP 6 patients and 100% for CEAP 5 patients. These rates are higher than those described in the literature, reported by Cabrera et al. 15 and Bergan et al., 16 and similar to the results obtained in another Brazilian study, 17 which treated 76 lower limbs with chronic venous ulcer and obtained healing rates of 84.2%. The data are also relevant for patients with ulcers already healed before treatment, confirming that the treatment is effective. In our survey, during a period of 20 months, there was no ulcer relapse in CEAP 5 patients.
Cavezzi and Parsi, 18 in a review on the complications of the technique, showed rates of DVT, thrombophlebitis, and pigmentation ranging from 1 to 3%, 4 to 5%, and 10 to 30%, respectively, differing from the rates of 20% for thrombophlebitis and 63% of pigmentation observed in the present analysis. A meta-analysis conducted with 69 articles 19 found rates of pain, pigmentation, and thrombophlebitis ranging from 25 to 26%, 17 to 18%, and 4 to 7%, respectively. Nevertheless, the majority of patients were classified as CEAP 2-3, which means less several clinical pictures of CVI. It is believed that the higher rate of complications found in this research results from the active search for information and from the fact that most of our cases included thicker varicose veins (CEAP 5 and 6).
The rate of DVT was 3%, without involvement of proximal veins or the need for specific treatment. There were no cases of symptomatic pulmonary thromboembolism. Jia et al. 19 reported the rates of systemic symptoms of up to 2.8% at the moment of injection. There were no adverse reactions in our series.
Symptom remission has shown statistical significance for all the symptoms analyzed in the study, which confirms the high rate of ulcer healing and the high rate of patients’ satisfaction.
In the current Brazilian reality, public services are not able to supply the demand for conventional surgeries for the treatment of varicose veins, due to the lack of professionals, or beds for inpatient care, or operating rooms available. An outpatient, low-cost and high-resolution technique, without the need for hospitalization and use of operating room, should be nationally encouraged and disseminated, because it has clearly shown to be an effective and safe alternative for the treatment of varicose disease associated with severe CVI. In the present study, 96% of the patients assigned grades from 8 to 10 for their treatment.
Although this study has some limitations, such as the lack of a control group and the application of a nonvalidated questionnaire, it points out that the use of the sclerotherapy technique will be able to satisfactorily assist a greater portion of the population assisted at public health services. Future studies are needed to analyze the impact on costs and confirm the clinical findings of the method, with the purpose of developing well-defined guidance and guidelines for the treatment of CVI, especially in the more severe stages of the disease.
Footnotes
Acknowledgements
The authors thank Sirleide Duarte Braga, Rosana Falasque, and Beatriz Helena Pavan Balducci Coelho.
Funding
This research received no specific grant from any funding agency in the public, commercial, or not-for-profit sectors.
Conflict of interest
None declared.