Therapeutic efficacy of vacuum-assisted-closure therapy in the treatment of lymphatic complications following peripheral vascular interventions and surgeries

Abstract

Objectives

Lymphatic complications, lymphocele and lymphorrhea being the leading, are generally encountered after vascular interventions and surgeries. The present study aimed to evaluate the outcomes of vacuum-assisted-closure (VAC) therapy, which we frequently prefer as the first-choice treatment for such complications.

Materials and methods

Among patients undergoing peripheral vascular intervention or surgery between January 2008 and February 2012, the medical files of 21 patients who received VAC therapy or other treatment due to symptomatic lymphatic complications were retrospectively analyzed and the results were discussed.

Results

Group I consisted of 10 patients (three with lymphocele and seven with lymphorrhea) who underwent VAC therapy as the first-choice treatment, Group II consisted of 11 patients of which 7 patients received various therapies before VAC therapy and 4 patients received other treatments alone. The patients who received VAC therapy as the primary therapy demonstrated more rapid wound healing, early drainage control, and shorter hospital stay. The mean hospital medical cost was €1038 (range, €739–1826) for the patients who primarily underwent VAC therapy; it was calculated to be €2137 (range, €1610–3130) for the other patients (p = 0.001).

Conclusion

In addition to its safety and good clinical outcomes, VAC therapy also has economic advantages and should be the primary method for the treatment of lymphatic complications.

Keywords

Lymphatic system complication vacuum-assisted closure

Introduction

Lymphatic complications, most commonly lymphocele and lymphorrhea, results from damage to the lymphatic ducts due to anatomical adjacency during vascular interventions and surgeries.^1,2 These complications usually occur in the inguinal region.³ The predisposing factors include advanced age, diabetes mellitus, re-operation, and distal leg infection.¹ Lymphocele is the localized cystic lymphatic collection, whereas lymphorrhea is referred to as intermittent lymph leakage through a skin fistula.^2,3 They are quite rare, but result in potentially severe and worrisome complications.^1–3 Although uncontrolled lymphatic drainage is initially sterile, it may become culture positive at a rate of 25%.⁴ Graft infection is the leading cause of morbidity and mortality.^1–3 The used therapeutic methods comprise sclerosing agents, surgery, as well as a conservative approach that includes bed resting, leg elevation, prophylactic antibiotic use, pressure dressing, and intermittent aspiration.^1–3,5–8 However, there is no consensus yet on the therapeutic method.^3,8 Prolonged duration of hospital stay, increased rate of wound site infection, complication, and relapses have been reported with the use of above-mentioned methods.³ Thus, vacuum-assisted closure (VAC) therapy has been recently recommended in small case series.^2,3,6,8 Nevertheless, in these studies, VAC therapy was performed in patients, who previously received other therapeutic methods with unsuccessful outcomes.

The present study aimed to evaluate the outcomes of VAC therapy, which we frequently preferred as the first-choice treatment (no other treatment before) for lymphatic complications and also the costs.

Material and method

Among patients who undergone peripheral vascular intervention or surgery between January 2008 and February 2012, the medical files of 21 patients who received VAC therapy alone or other therapeutic modalities due to symptomatic lymphatic complications were retrospectively analyzed and the results were discussed.

Data regarding age, gender, presence of risk factors (obesity, diabetes mellitus, and hypertension), medical history, and type of vascular surgery or intervention, presence of graft, type and localization of lymphatic complication, duration of VAC therapy, recurrences, post-treatment complications, and duration of hospital stay were recorded. In addition, hospital medical costs of the patients were also obtained and recorded from the invoice register of the Accounting Department of the Hospital. Complete approval of the Institutional Review Board was obtained for the present study. Hospital medical costs included all the costs only for the treatment of lymphatic complications and were calculated in Euro at the relevant exchange rates.

Diagnosis was established based on the complaints of the patient, as well as on the history and physical examination. Patients with the diagnosis of lymphocele were additionally evaluated by ultrasonography to distinguish lymphocele from hematoma and/or abscess. In suspected patients, the diagnosis was verified by biochemical and cytological examinations. All patients received prophylactic anticoagulant therapy. All patients received prophylactic anticoagulant therapy (Enoxaparine 100 U/kg, once per day). Culture and antibiograms were obtained in every patient with swabs.

The patients were divided into two groups: Group I (n = 10) including those who had primary VAC therapy and Group II (n = 11) including seven patients who received various therapies before VAC treatment and four patients who received other treatments.

Ten patients (three with lymphocele and seven with lymphorrhea) received VAC as the first-choice treatment. In the patients with lymphocele, VAC therapy was performed by converting lymphocele to lymphorrhea through a 1 cm skin incision. VAC therapy was performed by applying 125 mmHg negative pressure and by changing the dressings twice a week. In the patients having a graft in the surgical area, which was likely to be directly exposed to VAC, 125 mmHg negative pressure was achieved starting from 75 mmHg and monitoring the complications and distal blood flow. A VAC sponge (GranuFoam Dressing, KCI Licensing, Inc., San Antonio, TX, USA) was placed directly into the fistula tract. VAC therapy was discontinued with the development of granulation tissue and with the lymphatic leakage cessation during dressing. Primary skin closure was performed in the patients if the wound was clear enough; however, secondary healing was the choice in other patients in whom primary closure was not appropriate. Thereafter, wound care was provided by applying a wet dressing. Primary skin closure was performed in the patients whose skin defect was unlikely to heal secondarily. Since we have no portable VAC device, all patients underwent VAC therapy in the hospital.

Seven patients (one with lymphocele and six with lymphorrhea) received various therapies before VAC therapy; sclerotherapy was performed with intracavitary ethanol (95%) application in one patient with lymphocele, who did not respond to conservative therapy including daily aspiration followed by compression using an elastic bandage within a week; however, no response was observed after two injections. One week of conservative therapy (bed resting, wound care, leg elevation, compression, and prophylactic antibiotherapy) was performed in two patients with lymphorrhea. The remaining four patients underwent surgical therapy (exploration and ligation) after one week of conservative therapy; however, no response was observed. Four patients in Group II fully recovered with the conservative approach and surgical treatment.

Continuous variables were presented as mean ± standard deviation and were compared between groups using a t-test. All data were analyzed using the Statistical Package for the Social Sciences (SPSS, Inc., Chicago, IL, USA) version 16. A p < 0.05 was considered statistically significant.

Results

The mean age of 21 patients (9 males and 12 females) who received treatment for lymphocele or lymphorrhea was 51 (range, 35–77) years. Of the patients, five had diabetes mellitus, three had hypertension, and two had morbid obesity. One patient received inguinal radiotherapy, whereas one patient had recurrent surgery. Demographic and general characteristics of the patients are presented in Table 1.

Table 1.

Demographic and general characteristics of the study patients.

Patient	Age/ Gender	Medical history	Type of lymphatic complication	Site of lymphatic complication	Surgery to diagnosis (days)	Type of surgery	Graft	Duration of hospital stay (days)	Infections	Diagnosis to VAC (days)	Duration of VAC (days)	Treatment
1	49/F		LC	Inguinal	3	GSV stripping	N	16	−	−	−	Consarvative management + surgery
2	43/F		LF	Inguinal	3	GSV stripping	N	11	−	−	−	Consarvative management
3	39/F		LF	Inguinal	4	GSV stripping	N	10	−	−	−	Consarvative management
4	58/F	DM	LC	Inguinal	5	GSV stripping	N	17	−	−	−	Consarvative management + Surgery
5	48/M	DM	LF	Inguinal	3	Embolectomy femoral	N	7	−	1	7	VAC
6	38/F	Recurrent surgery	LF	Inguinal	3	SFJ ligation and GSV stripping	N	10	−	1	9	VAC
7	77/M	−	LF	Inguinal	11	Aorta‐femoral bypass	Y	7	−	1	7	VAC
8	42/F	−	LF	Inguinal	6	Femoral-popliteal bypass	Y	8	−	1	7	VAC
9	54/M	Morbid obesity	LC	Inguinal	7	Femoral angioplasty	N	8	−	1	8	VAC
10	55/F	Morbid obesity	LC	Inguinal	5	Femoral cannulation	N	9	−	1	9	VAC
11	67/M	HT DM	LF	Inguinal	4	Femoral-femoral bypass	Y	8	−	1	7	VAC
12	48/M	DM	LF	Inguinal	5	Embolectomy femoral	N	12	−	2	12	VAC
13	49/M	−	LC	Inguinal	6	Aorta-femoral bypass	Y	8	−	1	8	VAC
14	53/M	HT	LF	Inguinal	7	Aorta-femoral bypass	Y	17	−	1	15	VAC
15	44/M	Rectal Cancer, with history of radiation	LF	Inguinal	9	SFJ ligation and GSV stripping	N	32	+	12	19	Conservative approach + surgery + VAC
16	49/F	HT	LF	Inguinal	5	SFJ ligation and GSV stripping	N	20	−	6	12	Conservative approach + VAC
17	65/F	−	LF	Inguinal	10	SFJ ligation and GSV stripping	N	27	−	7	18	Conservative approach + VAC
18	48/F	−	LF	Inguinal	7	Embolectomy femoral	N	30	+	16	12	Conservative approach + surgery + VAC
19	52/F	−	LF	Inguinal	6	Angioplasty femoral	N	27	−	11	15	Conservative approach + surgery + VAC
20	62/M	DM	LF	Inguinal	8	Aorta femoral bypass	Y	30	+	9	17	Conservative approach + surgery + VAC
21	35/F	−	LC	Crural	5	GSV stripping + subfascial ligation perforating veins	N	25	−	9	14	Conservative approach + sclerotherapy + VAC

LF: lymphocutaneous fistula; LC: lymphocele; HT: hypertension; DM: diabetes mellitus; GSV: greater saphenous vein; SFJ: saphenofemoral junction; VAC: vacuum-assisted closure.

All patients with lymphocele (n = 6) had complaints of irritability and regional pain. The patients with lymphorrhea (n = 15) had the complaints of irritability and intermittent leakage, and two of them had leg edema. The patients who received VAC therapy as the first-choice treatment had no sign of infection. Of the patients who received various therapies before VAC therapy (n = 7), two had wound site infection prior to the VAC therapy and culture was positive in one patient for leakage, but the patient had no sign of infection. Staphylococcus aureus was isolated as the infectious agent in three patients (n = 3/7, 42%). These patients also received appropriate antibiotherapy according to the antibiogram results in addition to VAC therapy.

The lesion was in the inguinal region in all patients with lymphorrhea. Lymphocele was in the inguinal region in three patients and in the crural region in one patient. The patient who had lymphocele in the crural region underwent perforating vein surgery.

Extreme leg edema was noted in one patient who received VAC therapy. Doppler ultrasonography in this patient revealed collapse of the femoral vein due to the negative pressure of the VAC system, and there was no sign of thrombosis in the femoral vein. Negative VAC pressure was decreased, and the patient was treated with compression stockings and leg elevation. Six patients had vascular graft in the inguinal surgical area. A non-adherent layer was used between the graft and VAC foam, but the graft was directly exposed to VAC application in one patient. In this patient, distal blood flow was not affected, and no complications such as bleeding or aneurysm were identified. Skin closure after VAC therapy was provided by wet dressing in seven patients (secondary healing), whereas primary suture was used in 10 patients. However, since primary suture closure failed in one patient, the skin was closed with skin graft. None of the patients have exposure of the anastomosis in both groups.

Symptomatic lymphatic complications in the patients were determined on the average on the fifth day (range, 3–11 days) after the vascular intervention or surgery. The mean duration of hospital stay was 16 days (range, 7–32 days) in the whole study group (n = 21). The mean duration of hospital stay was 9 days (range, 7–17 days) in Group I (n = 10), whereas it was 22 days (range, 10–32 days) in Group II (n = 21) (p = 0.001). All patients were treated with VAC therapy for a mean of 12 days (range, 7–19 days). Group I patients were treated with VAC for a mean of 9 days (range, 7–15 days). In Group II patients, however, lymphatic leakage could be stopped with a mean VAC therapy of 15 days (range, 12–19 days) (p = 0.001). Duration of hospital stay and VAC application were shorter in the patients treated primarily with VAC.

The mean hospital medical cost was €1614 (range, €739–3130) for all patients; it was calculated to be €1038 (range, €739–1826) for the patients treated primarily with VAC therapy. The results of treatment methods in the whole study patients are presented in Table 2.

Table 2.

Results of treatment methods in the study patients.

	Whole study patients (n = 21)	Group I (n = 10)	Group II (n = 11)
Surgery to diagnosis(days)	5 ± 2.3	–	–
Duration of other treatment methods (days)	–	–	10 ± 2.8
Diagnosis of complication to start VAC treatment (days)	5 ± 4.9	1 ± 0.3	10 ± 3.3
Duration of VAC treatment (days)	12 ± 4.1	9 ± 2.6	15 ± 2.8 (p = 0.001)
Duration of hospital stay (days)	16 ± 9.03	9 ± 3.06	22 ± 8.06 (p = 0.001)
Treatment cost (€)	1614 ± 774.1	1039 ± 343,3	2137 ± 597 (p = 0.001)

Note: Data are presented as mean ± standard deviation. VAC: Vacuum-assisted closure.

No recurrence was noted in the whole study group during the mean of follow-up period of one month, and the success rate of VAC therapy was found to be 100% for the treatment of lymphatic complications.

Discussion

Lymphocele and lymphorrhea occur due to damage to the lymphatic ducts during surgery or intervention.^1–3 It has been demonstrated that closing the incision with fibrin glue also decreases the incidence of these complications.^3,9 Despite all efforts, lymphatic complications are frequently encountered after various vascular surgical interventions at a rate between 1.2% and 5.1%.^1–3,10 These complications are major challenges for the surgeon, especially when a prosthetic material is involved in the underlying wound. There is no consensus on optimal treatment for lymphatic complications. The application of surgical treatments suggested in the literature may increase the cost and duration of hospital stays and exposes patients to an additional invasive procedure.³ Likewise, lower hospital costs and length of hospital stay were detected in our study.

Conservative therapeutic approaches such as bed resting, leg elevation, prophylactic antibiotherapy, compression, and aspiration are mostly successful in the treatment of lymphatic complications.^1–3,7 On the contrary, surgical therapy, superficial irradiation, sclerotherapy, and snaring with superficial pledgeted sutures are also recommended because of likely complications, patient discomfort, prolonged hospital stay, risk for infection, and increased cost.^1,2,5,7,11 Lymphatic complications lead to prolonged hospital stay (22–36 days) and increased rate of wound site infection (18%).^1–3,5,6 In the literature, it has also been reported that mean duration of hospital stay is 19.8 days for surgical therapy and 47.6 days for conservative therapy, and uncontrolled lymphatic leakage poses a risk of infection at a rate up to 57%.^2,8 Surgical therapies such as early surgical ligation, muscle flap, and closure with superficial pledgeted sutures are additional invasive procedures.^1,3,7 Skin necrosis, neurovascular injury, and deterioration of anastomosis may occur; a recurrence rate of 10% has been reported with surgical treatment.^2,6,11 In addition, surgical therapy is not always easy to perform; large dissections may be required.¹

Surgical or conservative therapy can be attempted in patients who have lymphatic leakage with low flow rate⁴; but we also use this approach clinically as well as VAC therapy. The presence of a graft in the surgical area may result in infection and fatal outcomes.^1–4,12 Mortality and amputation rates due to graft infection have been reported to be 10–25% and 20%, respectively.⁴ Severe infections may occur and amputation may be required for these complications even after conservative therapy.¹

Recently, small case series in the literature have demonstrated high success rates for VAC therapy in the treatment of lymphatic complications.^2–4,6 It has been demonstrated that VAC therapy enhances granulation tissue formation in wounds, decreases interstitial fluid and edema, and accelerates wound healing by drawing away bacteria and inflammatory mediators from the wound site.^2,3,6,12,13 Such physiological changes ease the removal of bacteria and reduce the development of infection. Enhanced granulation tissue formation, as well, would stop the lymphatic leakage within a few weeks.⁶ The efficacy of VAC therapy has been demonstrated in the treatment of infected surgical wounds, traumatic wounds, compression ulcers, diabetic foot ulcers, and stasis ulcers.^12–14

Infection rates were reported higher in wounds with lymphatic leakage.¹⁵ Therefore, early application of VAC therapy may reduce progression of an infection. Effective therapy of lymphocele with its conversion to lymphorrhea was also reported.³ Repeated aspirations of the lymphoceles may lead to infection, thus due to the risk of infection and patient discomfort, we applied VAC therapy by converting symptomatic lymphocele into lymphorrhea and we provided early drainage control and no infection emerged in our patients. We suggest VAC therapy for the patients with lymphocele to control drainage in an early phase with confidence.

Potential complications when VAC is applied in the presence of graft include deterioration, bleeding and aneurysm at the anastomosis line, impaired distal blood flow, hematoma, deep vein thrombosis, and pulmonary embolus.^2,4,6,12 The manufacturer of the VAC system, KCI Medical, does not recommend VAC therapy for exposed vessels or vascular reconstructions.^4,12 However, in case of graft infection, unintended conditions, such as graft removal or amputation, can occur.^2,4,8,12 In order not to encounter such unintended conditions, VAC therapy is applied to preserve graft also in patients with graft in the surgical area.^{2–4,8,12,14,16–18} Close monitoring for distal blood flow, as well as complications such as bleeding, is necessary in such patients.^4,12 In the present study, graft was directly exposed to VAC application in one patient who had received other therapy methods with no response. The risk of graft infection was worrisome for us because of the presence of wound site infection in the same patient. VAC therapy with a lower suction pressure was initiated in this patient and the patient was closely monitored for the complications; no complication was observed. Moreover, deep vein thrombosis and pulmonary embolus have also been reported with the application of VAC therapy.^4,12 The risk is higher in patients in whom artery and vein are directly exposed to VAC therapy.^4,12 In the present study, collapse of the femoral vein was observed in one patient; however, no deep vein thrombosis was noted. Prophylactic anticoagulation would lower these complications.⁴

Immobilization due to the large size of VAC device was the unintended condition in all patients. Commercially available portable VAC devices would eliminate immobilization, shorten duration of hospital stay, and lower the cost.^3,12

The retrospective nature of the present study and the lack of a comparative group are among the limitations of the present study. Thus, prospective randomized studies are needed. There is limited number of retrospective studies showing that VAC therapy reduces medical cost; randomized studies may clarify this issue.

Conclusion

In conclusion, in addition to its safety and good clinical outcomes, VAC therapy also has economic advantages in the treatment of lymphatic complications. We consider that VAC therapy is a primary and effective method for the treatment of lymphatic complications as it is less invasive, provides more rapid wound closure, and has a success rate of 100%.

Footnotes

Conflict of interest

We declare that there is no conflict of interest regarding the preparation and publication of this manuscript.

Funding

This research received no specific grant from any funding agency in the public, commercial, or not-for-profit sectors.

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