Approach to surgical management for deep venous insufficiency

INTRODUCTION — 

Chronic venous insufficiency that is due to either loss of deep venous valvular competency or obstructive deep venous lesions is a common and debilitating condition that may result in ulceration in nearly 2.5 million patients per year in the United States [1]. The mainstay of treatment is primarily compression therapy and wound care if ulceration has developed, but several invasive procedures have been suggested for management of the disease.

The surgical management of deep vein insufficiency is reviewed. The pathophysiology, classification, clinical features, and conservative management of chronic venous insufficiency including venous ulcerations are reviewed separately.

●(See "Pathophysiology of chronic venous disorders" and "Classification of lower extremity chronic venous disorders".)

●(See "Overview of lower extremity chronic venous disease" and "Clinical manifestations of lower extremity chronic venous disorders".)

●(See "Evaluation and management of chronic venous insufficiency including venous leg ulcer" and "Compression therapy for the treatment of chronic venous insufficiency".)

The approach to treating superficial venous insufficiency including various types of ablation therapies is discussed separately. (See "Approach to treating symptomatic superficial venous insufficiency".)

VENOUS ANATOMY — 

Chronic venous insufficiency predominantly affects the lower extremity, which consists of a superficial and deep system of veins (figure 1 and figure 2) as determined by the vessel’s location in respect to the muscular fascia. The deep veins drain the musculature, and the superficial veins drain the skin and subcutaneous space, and these two systems are connected via perforator veins. Both contain a variable number of valves that decrease in number more proximally in the lower extremity [2]. Venous nomenclature has become standardized with most deep veins sharing the name of the corresponding artery (table 1) [3].

Patients with chronic venous insufficiency are typically classified based on their clinical manifestations (C), etiology (E), anatomic distribution (A), and pathophysiology (P) of their underlying venous disease (ie, CEAP classification (table 2 and table 3)) [4].

CANDIDATES — 

Decisions for surgical intervention for deep venous disease are largely based on outcomes of observational data and expert opinion [5-7]. Patients who might be considered for surgical management of deep venous incompetency are those with severe chronic venous insufficiency (ie, CEAP 4 [lipodermatosclerosis] or higher disease (table 2)) who often have poorly controlled ulcerations that are recalcitrant or recurrent despite compression, aggressive wound care, and/or treatment of superficial venous disease.

Valve surgery can provide sustained venous ulcer healing and reduced venous hypertension in patients with both primary and secondary deep venous insufficiency [6]. While some series show promising outcomes, there is no high-quality evidence supporting venous reconstruction [8]. As such, the initial emphasis should be on optimizing conservative medical management and improving patient compliance with compression therapy. Thereafter, patients should be evaluated on a case-by-case basis when considering surgery.

APPROACH TO THE PATIENT — 

The approach to surgery for deep venous insufficiency depends on the level and extent of venous insufficiency and the presence of proximal venous obstruction.

When iliocaval venous obstruction is present, it must be corrected first. Ulcer healing occurs in up to 60 percent of patients following treatment of iliofemoral venous disease using endovenous or open surgical techniques [9]. Because of this, and also technical challenges, deep vein valve surgery often remains the treatment of last resort [5]. (See "Endovenous intervention for iliocaval venous obstruction" and "Techniques used for open iliocaval venous reconstruction".)

It is important to recognize and treat superficial axial venous insufficiency. Axial vein ablation alone may correct segmental deep venous insufficiency in up to 50 percent of patients and can improve the healing of venous leg ulcers and prevent recurrence [10]. It may obviate the need for deep vein valve surgery in selected patients. In one population study, 48 percent of patients with deep venous disease also had superficial venous disease [11]. (See "Evaluation and management of chronic venous insufficiency including venous leg ulcer", section on 'Superficial axial venous reflux'.)

Once proximal venous occlusive disease and superficial venous insufficiency have been addressed, evaluation for possible valve procedures can be done. For deep venous insufficiency at or below the inguinal ligament, options generally involve external banding, internal and external valvuloplasty, valve or vein transposition, autogenous valve substitution, repair or revision of the native valve vein, or replacement with another valve. Prosthetic valves represent a novel therapy. These techniques are reviewed below. (See 'Established valve techniques' below and 'Investigational valve techniques' below.)

Contraindications — While there are no absolute contraindications to deep venous reconstruction, patients with untreated iliocaval occlusive disease or superficial venous disease should have these pathologies corrected first. In addition, patients should be candidates for and able to tolerate perioperative antiplatelet and/or anticoagulation to maintain patency of the repair and treat potential complications related to venous thromboembolism.

Venous imaging — Most patients will have undergone venous duplex ultrasound that established the diagnosis of deep venous insufficiency; however, when planning an intervention, venography or cross-sectional imaging is mandatory. While computed tomography venography can reliably identify iliocaval occlusive disease, we find descending venography to be superior for surgical planning. This is due to the ability to identify anatomic variations such as venous duplications as well as evaluate for post-thrombotic changes, valve competence, and iliocaval disease in one setting.

ESTABLISHED VALVE TECHNIQUES — 

Several surgical techniques have been devised to potentially treat deep venous valvular incompetence, all of which involve recreating the valvular function lacking in patients with this disease. No single surgical option has universally high success rates that would prompt its general recommendation for use in all patients. As such, with no high-quality data directly comparing the various techniques, the selection and performance of these procedures are highly dependent on the surgeon's experience and the patient's anatomic suitability for a given technique.

Most reports are from uncontrolled, single-center experiences [7,8]. While some randomized trials exist, these are predominantly small studies with limited numbers of patients and with differential reporting of outcomes [12-15]. Four trials have compared valvuloplasty and superficial venous surgery with valvuloplasty alone in patients with primary valvular incompetence. Overall, ulcer-free rates were between 54 and 100 percent for up to five years, but whether this was due to the valve procedure or ancillary treatment of superficial reflux or compression therapy could not be determined.

Observational studies have reported a similar patency range for a variety of techniques [7,8]. Treatment of primary venous disease appears to be associated with improved durability compared with the treatment of secondary (eg, post-thrombotic) disease [16-19]. Pooled outcomes from a systematic review of individual techniques are presented below [7].

Valvuloplasty — Direct surgical revision of the valve apparatus is the earliest and the most reported surgical technique for deep venous reflux. Many variations of the procedure have been described; however, they all broadly fall into two categories:

●Internal valvuloplasty – Internal valvuloplasty entails the creation of a venotomy in the femoral vein through which redundant valve leaflets are resected and/or resuspended [20]. When done appropriately, internal valvuloplasty improves valve competence and wound healing rates approach 90 percent at 24 months [21]. [22]

●External valvuloplasty – External valvuloplasty similarly has multiple described variations. All methods involve sharp adventitial dissection of the femoral vein, identification of valve attachment lines, and transmural resuspension of valve leaflets [20]. Resuspending sutures are placed through the vein wall at progressive obliquity to tighten the valve cusp and narrow the overall diameter [23]. A benefit of this technique is not needing to violate the venous lumen or manipulate delicate valvular structures [24].

Although no studies directly compare internal and external valvuloplasty, outcomes are generally similar between the two approaches [25]. In a systematic review, pooled estimates following valvuloplasty for primary valvular incompetence were as follows [7]:

For internal valvuloplasty:

●Ulcer healing – 89 percent

●Ulcer recurrence – 7 percent

●Valve patency – 98 percent

●Valve competence – 87 percent

●Pain improvement – 87 percent

●Edema improvement – 77 percent

●Lipodermatosclerosis improvement – 85 percent

For external valvuloplasty:

●Ulcer healing – 79 percent

●Ulcer recurrence – 19 percent

●Valve patency – 100 percent

●Valve competence – 80 percent

●Pain improvement – 84 percent

●Edema improvement – 82 percent

Venous banding — Venous banding has been pursued to treat one of the primary causes of reflux, vein dilation, with promising results. A polytetrafluoroethylene or Dacron cuff is used to narrow the femoral or popliteal veins by approximately one-third [20]. After appropriate sizing, the prosthetic cuff is sutured together, ensuring that the vein wall is not incorporated in the suture. Like with external valvuloplasty, this technique has the benefit of avoiding direct manipulation of the underlying valve architecture. Additionally, while effective when used in isolation, venous banding has been shown to decrease late treatment failure when used as an adjunct to valvuloplasty [26,27]. While not investigated in combination with all modalities, it may be prudent to use banding whenever directly manipulating a native valve apparatus to prevent late failure and recurrent reflux. In isolation, venous banding has demonstrated ulcer healing rates of 75 percent at three months, with over 90 percent of patients experiencing improvement in their symptoms [26].

In a systematic review, the pooled outcomes following venous banding were as follows [7]:

●Primary valvular incompetence:

•Ulcer healing – 92 percent

•Ulcer recurrence – 7 percent

•Valve patency – 100 percent

•Valve competence – 87 percent

•Pain improvement – 88 percent

•Edema improvement – 100 percent

●Secondary valvular incompetence:

•Ulcer healing – 71 percent

•Edema improvement – 33 percent

Valve translocation — The translocation of competent vein segments in line with incompetent deep axial veins has been attempted in a variety of different configurations. Generally, the femoral vein or great saphenous vein is translocated to route venous return through a competent deep femoral vein or saphenofemoral junction. This can be accomplished by direct reimplantation of the femoral vein onto the deep femoral vein or by implanting the great saphenous vein onto the femoral vein with proximal femoral vein ligation [20,28].

Outcomes of valve translocation have been mixed, with wound healing rates varying from 50 to 80 percent at 24 months. Although no direct comparison exists, it is generally accepted that valve translocation is inferior to valvuloplasty [29]. (See 'Valvuloplasty' above.)

Valve transplantation — Like valve translocation, valve transplantation has been explored to place competent valves in line with deep venous return. Donor valves are harvested from either the brachial or axillary vein and interposed to the femoral vein [20].

While direct manipulation of the valve apparatus is avoided, this approach has multiple technical limitations. The first is a high rate of valvular incompetence in potential donor veins. Almost 50 percent of explored donor valves are incompetent and nearly 15 percent of bilateral valve explorations yield no suitable donor vein. In addition, of the valves that are suitable for transplantation, many become mildly incompetent after grafting. Due to the sensitivity of valve function to overall vein geometry, donor grafts placed with excessive tension or laxity will lead to incompetence [30,31].

Due to the many different mechanisms by which the transplanted valve can lose competence, and variations in technique, outcomes have been widely varied. While some report greater than 60 percent ulcer-free recurrence at 10 years, others report ulcer healing rates of 25 percent with a median time until symptomatic recurrence of just 12 months [31,32].

In a systematic review, pooled estimates for valve transplantation for secondary valvular incompetence were as follows [7]:

●Ulcer healing – 70 percent

●Ulcer recurrence – none

●Valve incompetence – 69 percent

●Pain improvement – 69 percent

●Hematoma – 6 percent

●Thrombosis – 6 percent

Neovalve creation — The creation of a new valve apparatus has been described in many ways, including using an invaginated great saphenous vein to fashion a valve in the common femoral vein and by creation of a valve cusp by dissection of a thickened post-thrombotic wall [33,34]. The benefit of these techniques is that an intact valve architecture is not required. For this reason, neovalve creation is of particular benefit to patients with congenital avalvulosis and those with extensive post-thrombotic changes where valve leaflets may be obliterated. Phlebitic veins can be of use for neovalve creation as described in one particular technique in which the layers of a thickened post-thrombotic vein wall are dissected to create one or more artificial valve cusps [20,34]. Neovalve creation has demonstrated up to 100 percent competence at six months and freedom of ulcer recurrence of nearly 85 percent at four years [33,35].

In a systematic review, pooled outcomes of neovalve creation for secondary deep valvular incompetence were as follows [7]:

●Ulcer healing – 85 percent

●Ulcer recurrence – 15 percent

●Valve patency – 97 percent

●Valve competence – 88 percent

●Lipodermatosclerosis improvement – 55 percent

INVESTIGATIONAL VALVE TECHNIQUES — 

Several investigational techniques have been used to treat deep vein valve incompetence, some with more success than others. While prosthetic valves generally have unacceptably high thrombosis rates, a novel bioprosthetic valve (ie, VenoValve)and other techniques (eg, BlueLeaf System, internal compression therapy) have demonstrated sustained improvement in deep venous reflux (<1 second); however, it should be noted that available results are from early feasibility studies with exceedingly small numbers of patients [36,37].

Prosthetic valves — Prosthetic valves for the deep venous system have been extensively investigated using a wide variety of synthetic materials. Regardless of the material used, these devices all suffer from similar modes of failure, including early thrombosis, extensive neointimal hyperplasia, and loss of valve function due to tissue ingrowth. Given these limitations, these devices have largely been relegated to animal studies [20].

Bioprosthetic valves — Biologic prosthetic valves have similar shortcomings as prosthetic valves although likely to a lesser degree. As with synthetic valves, numerous biologic materials have been investigated to overcome unacceptably high thrombosis rates. Tissues investigated have included decellularized allografts, porcine intestinal submucosa, bovine jugular vein, and cryopreserved cadaveric vein [38,39].

A novel biologic valve consisting of a porcine aortic monocusp mounted on a stainless-steel frame (VenoValve) has completed its first human study and is enrolling in a broader safety and efficacy trial [40]. In the two-year results, patients have maintained an average of <1 second of reflux and 100 percent ulcer healing without recurrence [36].

One study reported the following outcomes for allografts [7]:

●Ulcer healing – 75 percent (95% CI 58-88)

●Ulcer recurrence – 21 percent (95% CI 7-42)

●Valve patency – 100 percent (95% CI 91-100)

●Valve competence – 75 percent (95% CI 58-88)

Endovascular neovalve creation — Given the success of direct surgical neovalve creation, attention has focused on overcoming the highly technical requirements of performing the procedure. An endovascular method of neovalve creation (BlueLeaf Endovenous Valve Formation System) allows for the creation of a neovalve by hydrodissecting the vein wall with a balloon-apposed needle. The newly created plane is then expanded with a mechanical dissector to fashion a valve pocket [41]. This device has completed enrollment in an early feasibility study. Early results have demonstrated significant improvement in symptoms of treated patients; however, hemodynamic improvements were modest, with an average improvement in reflux time of just .3 seconds [42].

While this method is promising in that it standardizes neovalve creation and avoids nonautologous tissue, it lacks the ability to tether the valve cusps in a partially open position, an adjunctive technique of open neovalve creation that can decrease the risk of parietal re-adhesion, which is a well-documented mode of failure in neovalve creation [43].

Internal compression therapy — Internal compression therapy (ICT) has been demonstrated to be effective for treating deep venous reflux by decreasing the diameter of the femoral vein and/or saphenofemoral junction. Most analogous to venous banding, internal compression therapy consists of percutaneous deposition of hyaluronic acid and cyanoacrylate adjacent to the vein wall through two cannulas. While long-term outcomes are not yet available, this technique has the theoretical benefit of being able to treat superficial and deep venous reflux in the same setting while avoiding thrombotic complications [37,44].

COMPLICATIONS — 

Native venous reconstructions, though technically difficult, are remarkably safe. There has been no reported mortality in contemporary series, with the most frequent complications being those related to the surgical site.

Deep vein thrombosis — Between 4.5 and 8 percent of deep vein valve surgeries are complicated by perioperative deep venous thrombosis (DVT) [21]. Thrombosis most often occurs at the site of reconstruction, and thus, is an indicator of technical failure of the procedure (see 'Established valve techniques' above). Because of the risk for DVT, postoperative duplex ultrasonography is obtained. (See 'Postprocedural ultrasonography' below.)

While still under active investigation, novel treatments appear to be safe and effective, with no venous thromboembolism or surgical site complications reported for the BlueLeaf system, VenoValve, or internal compression therapy techniques. (See 'Investigational valve techniques' above.)

Other minor complications — Approximately 5 to 20 percent of patients will experience minor complications such as hematoma, seroma, or wound infection. From a systematic review, pooled complication rates were as follows [7]:

Internal valvuloplasty:

●Wound infection – 1 percent (95% CI 0-2)

●Hematoma – 2 percent (95% CI 0-10)

●Lymphocele – 5 percent (95% CI 0-14)

●Thrombosis – 2 percent (95% CI 0-6)

External valvuloplasty:

●Wound infection – 1 percent (95% CI 0-6)

●Hematoma – 5 percent (95% CI 1-17)

●Lymphocele – None

●Thrombosis:

•Primary incompetence – 0 percent (95% CI 0-3)

•Secondary incompetence – 15 percent (95% CI 2-45)

External banding (primary valvular incompetence):

●Wound infection – 2 percent (95% CI 0-13)

●Hematoma – 7 percent (95% CI 2-18)

●Lymphocele – 1 percent (95% CI 0-6)

●Thrombosis – 1 percent (95% CI 1-2)

Neovalve formation:

●Hematoma – 8 percent (95% CI 2-17)

●Lymphocele – 9 percent (95% CI 3-17)

●Thrombosis – 1 percent (95% CI 0-5)

●Wound infection – None

●Pulmonary embolism – None

ROUTINE CARE AND FOLLOW-UP

Anticoagulation — Perioperative anticoagulation protocols vary between surgical techniques and should be approached on a case-by-case basis, considering the technical and patient-specific factors. However, for procedures with a high thrombotic risk (direct manipulation of valve apparatus, permanent intravascular prosthetic), we suggest at least three months of anticoagulation [21,22].

Compression therapy — While the role of compression therapy is controversial after superficial venous ablation, compression garments are mandatory for all patients following deep vein valve surgery, with consideration to the use of thigh-high compression during the first 48 hours after the procedure. Patients should ambulate regularly during the first month to help prevent deep venous thrombosis.

Postprocedural ultrasonography — Routine postprocedural ultrasound should be performed one to two weeks after the procedure, particularly for procedures requiring intravenous manipulation.

Following the initial ultrasound study, additional routine imaging is unnecessary in the absence of symptoms. For any unexplained limb swelling, worsening symptoms, or poor wound healing, repeat duplex imaging should be performed.

SOCIETY GUIDELINE LINKS — 

Links to society and government-sponsored guidelines from selected countries and regions around the world are provided separately. (See "Society guideline links: Chronic venous disorders".)

INFORMATION FOR PATIENTS — 

UpToDate offers two types of patient education materials, "The Basics" and "Beyond the Basics." The Basics patient education pieces are written in plain language, at the 5^th to 6^th grade reading level, and they answer the four or five key questions a patient might have about a given condition. These articles are best for patients who want a general overview and who prefer short, easy-to-read materials. Beyond the Basics patient education pieces are longer, more sophisticated, and more detailed. These articles are written at the 10^th to 12^th grade reading level and are best for patients who want in-depth information and are comfortable with some medical jargon.

Here are the patient education articles that are relevant to this topic. We encourage you to print or e-mail these topics to your patients. (You can also locate patient education articles on a variety of subjects by searching on "patient info" and the keyword(s) of interest.)

●Basics topics (see "Patient education: Varicose veins and other vein disease in the legs (The Basics)")

●Beyond the Basics topics (see "Patient education: Lower extremity chronic venous disease (Beyond the Basics)")

SUMMARY AND RECOMMENDATIONS

●Deep venous insufficiency – Deep venous insufficiency is generally managed with compression therapy. If venous leg ulceration is present, additional measures to support wound care are used. Patients with severe venous disease (C4 and higher disease (table 2)) that is refractory to conservative management may benefit from procedures that aim to restore venous patency or venous valvular function. (See 'Candidates' above.)

●Approach by disease level – The approach to surgery for deep venous insufficiency varies by the level of disease. (See 'Approach to the patient' above.)

•Iliocaval venous obstruction – For iliocaval venous obstruction, the main objective is to restore venous flow.

•Femoral or infrainguinal obstruction – For disease at or below the inguinal ligament, the primary aim is to restore venous valvular function.

●Established valve techniques – Several established surgical techniques have been used to recreate valvular function; however, no one surgical option has been demonstrated to be superior to any other. With no high-quality data to guide technique selection, the performance of these procedures is highly dependent on the surgeon's experience. These techniques include (see 'Established valve techniques' above):

•Valvuloplasty – Valvuloplasty involves direct surgical revision of the valve apparatus, which can be performed internally (requires venotomy) or externally, which resuspends the valve. Outcomes are generally similar between the two approaches.

•Venous banding – Venous banding using a cuff of prosthetic material can be performed to manage vein dilation.

•Valve translocation – Valve translocation involves placing a competent vein segment in line with the incompetent deep axial vein.

•Valve transplantation — Valve transplantation involves harvesting a donor valve from the brachial or axillary vein and interposing it within the deep femoral vein. Unfortunately, the high rate of valvular incompetence in potential donor veins limits this technique.

•Neovalve creation — The creation of a new valve apparatus can be accomplished by invaginating the great saphenous vein to fashion a valve in the common femoral vein or by creating a valve cusp in a thickened post-thrombotic wall by dissecting a portion of the vein wall. These techniques can be used in patients with congenital avalvulosis or extensive post-thrombotic changes where valve leaflets may be obliterated.

●Investigational valve techniques – Promising investigational techniques include a novel bioprosthetic valve (ie, VenoValve), an endovascular method for neovalve creation (eg, BlueLeaf System), and internal compression therapy, a minimally invasive technique that reduces vein diameter. (See 'Investigational valve techniques' above.)

●Postoperative deep vein thrombosis and prophylaxis – Vein valve surgery can be complicated by deep vein thrombosis (DVT), which most often occurs at the operated vein valve site and represents a technical failure of the procedure. (See 'Complications' above.)

•Routine postprocedural ultrasound should be performed one to two weeks after the procedure to evaluate for DVT, particularly for procedures requiring intravenous manipulation. Following the initial ultrasound study, routine imaging is unnecessary. If unexplained limb swelling or increased pain occurs, or any wounds get worse, repeat duplex imaging should be performed. (See 'Postprocedural ultrasonography' above.)

•For procedures associated with a high risk for thrombosis (eg, direct manipulation of valve apparatus, permanent intravascular prosthetic), we suggest anticoagulating the patient for at least three months (Grade 2C). (See 'Anticoagulation' above.)

●Compression therapy – Following vein valve surgery, compression therapy is continued with consideration for the use of thigh-high compression during the first 48 hours after the procedure. Patients should ambulate regularly during the first month to help prevent DVT. (See 'Compression therapy' above.)