Optimizing Management of Chronic Venous Insufficiency

Kenneth Murphy, MD, FSIR

Disclosures

June 04, 2003

Editorial Collaboration

Medscape &

Chronic venous disease of the lower extremity is a very common condition in the United States. It is estimated that 3% to 8% of the US population has symptomatic lower-extremity venous insufficiency and 1% of adults over the age of 60 years have chronic ulceration.[1] The estimated total healthcare cost of treating this disease to the US economy was approximately $1 billion in 2002.[1] The clinical manifestations of lower extremity venous insufficiency vary from minor cosmetically displeasing lesions to severely disabling disease. The most common clinical manifestation of venous insufficiency in the lower extremities is varicose veins, which are estimated to occur in 30% to 60% of adults. The predominant risk factors associated with the development of varicose veins include female gender, pregnancy, and increased age.

Traditionally, surgical vein stripping or ligation has been used to manage patients with lower-extremity varicose veins. These treatments are associated with significant pain, a prolonged recovery period, and a high rate of recurrence. Recently, new percutaneous endovenous techniques have been introduced that permit a minimally invasive option for the management of patients with lower-extremity venous insufficiency. The 28th Annual Scientific Meeting of the Society of Interventional Radiology (SIR), which convened in Salt Lake City, Utah, March 27-April 1, devoted significant emphasis to this topic, including featured symposia, plenary session, workshop session, and a scientific session. The featured symposia, plenary session, and workshop profiled the epidemiology, pathophysiology, clinical patterns, and duplex ultrasound evaluation of venous insufficiency, percutaneous techniques for the treatment of saphenous vein reflux (radiofrequency ablation and endovenous laser ablation), prosthetic venous valves, and practice development issues. Robert J. Min, MD, Cornell Vascular, New York, New York, and John A. Kaufman, MD, Dotter Interventional Institute, Portland, Oregon, moderated the symposia and plenary sessions, respectively.

Pathophysiology and Anatomic Considerations of Lower-Extremity Venous Insufficiency

Managing patients who have lower-extremity venous insufficiency necessitates a thorough understanding of the venous anatomy and pathophysiology of venous insufficiency. The lower-extremity venous anatomy is composed of a deep and superficial system that is regulated by a calf muscle pump system. The superficial venous system is composed of the greater and lesser saphenous veins in the lateral (subdermic) venous system. The deep venous system includes the deep veins of the thigh and calf. The deep venous system and superficial system communicate via the major perforating veins, which predominate in the calf. There are four named groups of perforator veins associated with greater saphenous vein (GSV) reflux that are clinically relevant to the physician diagnosing and treating venous insufficiency. They include the Hunterian (mid-upper medial thigh), Dodd's (above medial knee), Boyd's (medial below knee), and Cockett's veins (above ankle). The pathophysiology of venous insufficiency is most often caused by valvular failure with resultant varicose veins. Valvular failure results in reflux, elevated venous pressure, and dilatation in that segment. The most common site of reflux is at the saphenofemoral junction (SFJ) with resultant superficial varicosities. A second, less common, cause of varicosities is valvular incompetence involving the perforator veins, which is typically a result of high-pressure leak gradient toward the superficial venous system with subsequent dilatation and varicose vein formation.

Clinical and Duplex Evaluation

Neil Khilnani, MD, Cornell Medical Center, New York, New York, stressed that clinical assessment and duplex evaluation are critical to the success of any endovenous procedure. Clinical evaluation involves compiling a detailed patient history with targeted questions that include questions about history of pregnancy, trauma, hypercoagulable syndromes, and prior deep venous thrombosis. Physical examinations of the patient should be performed in the erect position with attention to the lower-extremity, lower abdomen, and pubic region. Dr. Khilnani stressed that the clinical exam should be supplemented by a comprehensive duplex ultrasound evaluation. The principle objectives of the duplex evaluation include determining the patency of the deep and superficial venous systems, identifying and localizing reflux, and pinpointing the blood flow source to the varicose segments. The GSV is mapped with duplex ultrasound from the level of the SFJ to the level of the ankle. The exam is performed with the patient standing, and with the patient's weight supported on the contralateral limb. The leg to be evaluated is flexed, and the exam commences from the top of the thigh to the level of the lowest varicosities and/or ankle. The saphenofemoral junction (SFJ) is assessed for competency. Reflux is evaluated using color and pulse wave Doppler with simultaneous augmentation of the venous segments below the level that is being examined. In similar fashion, the lesser saphenous vein and perforators are examined. The deep venous system is also interrogated for any underlying deep venous thrombosis (DVT).

Percutaneous Techniques for Treatment of Saphenous Vein Reflux

There are two techniques for the percutaneous endovenous treatment of GSV reflux. These techniques are radiofrequency ablation and laser occlusion. Radiofrequency involves using the Closure Device (VNUS, Medical Technologies, Sunnyvale, California), which is a US Food and Drug Administration-approved technology that promotes venous occlusion by applying radiofrequency (RF) thermal energy to the wall of the vein. The device consists of a 6-F or 8-F catheter containing retractable electrodes that deliver the RF energy. A generator delivers electrical current to the probe, which results in frictional heating at the probe tip. The heating produces local thermal energy, which, when maintained at 85º C, results in vessel wall damage that is characterized by protein denaturation and collagen deposition. The device is placed in the GSV at/or below the knee, using ultrasound guidance. Dr. Rosenblatt, Connecticut Image-Guided Surgery, Milford, Connecticut, stressed that the device must be positioned close (1-2 cm) to the SFJ for clinical success. The device is retracted along the course of the GSV. The procedure can be performed in an outpatient setting using local tumescent anesthesia, which involves infiltrating the perivenous space with a large volume of 0.25% lidocaine. According to Dr. Rosenblatt and other investigators at SIR 2003, conscious sedation is not generally required for this procedure. Dr. Rosenblatt indicated that other refluxing veins identified during the preprocedure duplex mapping can be treated with RF ablation, provided the course is straight enough to facilitate device passage under fluoroscopic-guidance, which is typically done through a guidewire. A recent study compared postprocedure pain, the convalescent period, and the cost of the RF endovenous approach with conventional surgical stripping. The study documented that the incidence of postoperative pain, recovery time, and cost of the RF obliteration is significantly less than conventional surgery.[2]

In the scientific session at SIR devoted to this topic, Dr. Rosenblatt[3] described the radiographic and clinical outcomes of RF treatment of GSV reflux in 124 patients who had symptomatic venous insufficiency. Symptomatic improvement occurred in 97.1% of patients, and ultrasound occlusion of GSV was documented in 95.7% of patients on a mean follow-up at 3.4 months. Complications included mild transient paresthesias (11%) and skin burns (1.4%). Treatment failures were retreated with success in every case. Treatment failures were associated with a large incompetent GSV perforator, which the investigators hypothesized may have acted as a heat-sink preventing adequate thermal ablation of the vein wall at that level. In a second scientific presentation, Dr. Rosenblatt[4] described RF ablation of non-greater saphenous lower extremity veins for managing venous insufficiency. In this study, 42 patients who had non-GSV reflux were treated with radiofrequency occlusion. Technical success was achieved in all cases, duplex ultrasound occlusion was documented in 92.6% of cases on follow-up, and symptomatic improvement was seen in 96% of cases. Non-greater saphenous lower extremity veins treated included the anterior-lateral tributaries, GSV perforators, and lesser saphenous veins.

Concurrent with the development of RF venous ablation, laser techniques have been used with success. In 1998, the fiberoptic laser fiber was introduced as an alternative method for using laser energy for treatment of GSV reflux. The procedure is analogous to the radiofrequency technique and is typically performed under ultrasound guidance after local anesthesia is administered with tumescent anesthesia. Treatment is limited to GSVs that have diameters of 2 mm-12 mm. The endovenous laser catheters are inserted into the GSV through a 5 F introducer sheath, at or below the knee level. The laser tip is positioned at approximately 1-2 cm below the SFJ, and the position of the tip is confirmed on ultrasound. The typical diode laser energy is 810 nm (Diomed, Inc., Hanover, Massachusetts) and/or 980 nm wavelength (Angiodynamics, Inc., Queensbury, New York). The laser induces focal injury to the endothelium and vein wall without significant extension into fat and tissue. Results of the endovenous laser technique for GSVs demonstrated 99% vessel occlusion at 1-9 months follow-up.[5] In a scientific session, Robert Min, MD,[6] described 2-year follow-up results for management of saphenous vein reflux using this technique. In his study, a total of 389 GSVs in 344 patients were treated with the 810 nm diode laser. At follow-up, ultrasonography was obtained in 88 limbs, and 93% of these were occluded at a minimum of 2 years. There were no skin burns, paresthesias or DVTs. Dr. Min concluded that endovenous laser treatment of saphenous vein reflux is a successful technique with a low (7%) recurrence rate and a minimum complication rate.

After occlusion by either laser technique or radiofrequency ablation, the patient is discharged and instructed to wear compression stockings for approximately 7 days. The patient is also instructed to continue normal daily activities, without significant exercise during this initial recovery period. Postablation sclerotherapy or ambulatory phlebectomy can be performed approximately 4 weeks after the initial procedure.

Sclerotherapy of Spider Veins and Varicose Veins

Dr. Min and other presenters on this topic at SIR 2003 stressed the importance of adjunct sclerotherapy for the treatment of spider veins and varicose veins after GSV occlusion. These additional treatment strategies are necessary to ensure a "successful outcome and amelioration of symptoms and cosmetic defects," according to Dr. Min. The mainstay of such therapy is sclerotherapy. The indications for adjunct techniques include telangiectasias, reticular veins, and residual varicose veins. Injection sclerotherapy involves targeted delivery of a sclerosant agent into a superficial vein, which initiates intimal irritation and is followed by an intense inflammatory reaction and the subsequent ingrowth of granulation tissue and fibrosis. This results in a fibrous cord-like vein that is permanently obliterated. The sclerosant agents available include sodium tetradecyl sulfate, polidocanol, dextrose/sodium chloride, and chromated glycerin. Sodium tetradecyl sulfate and polidocanol are preferred agents; however, polidocanol is currently not approved for use in the United States. The volume injected depends on the target; typically, 0.2 to 0.5 mL is used for reticular veins and 0.1 to 0.4 mL is used for telangiectasias. The injection is typically performed with the patient in the horizontal position, which reduces the venous pressure and allows for complete injection into an "empty" vein. The sclerosant injection is usually painless; typically, a compression bandage or stocking is applied postinjection for a period of 3 days to several weeks. Dr. Min and other researchers stressed the importance of diligent follow-up at approximately 2 weeks to evaluate patients for optimal results, as well as for areas of "trapped" blood. Areas of trapped blood can be associated with focal tenderness and may result in pigmented areas that are cosmetically displeasing. A simple puncture with a 25 G or slightly larger gauge needle facilitates aspiration of trapped blood.

An additional adjunct technique is ambulatory phlebectomy, which is a minor surgical procedure that involves careful dissection, isolation, and ligation of superficial and reticular veins.

Future Venous Therapeutic Alternatives

Dusan Pavcnik, MD, Dotter Institute, Portland, Oregon, outlined some of the exciting developments in the technology of prosthetic venous valves. One such valve is the bioprosthetic, bicuspid valve, which is composed of a square stent and small intestinal submucosal covering. This prosthetic valve has been placed successfully in a sheep model. A manufactured, percutaneous, nonimmunogenic venous valve is currently under development. This prototype employs a square stent as the foundation supporting a prosthetic valve biomaterial. These valves are potentially available in various diameters and may not require anticoagulation. Further development and clinical trials to explore the efficacy of these technologies are underway.

Ramping Up Your Venous Insufficiency Practice

Gerald Niedzwiecki, MD, Meese Countryside Hospital, Safety Harbor, Florida, spotlighted the elements of establishing a successful venous management practice. A dedicated physician and staff with appropriate training are mandatory. In addition, most chronic venous insufficiency work is best managed in an outpatient setting. Success is dependent on the state-of-the-art equipment, nursing, ancillary staff, and diligent patient follow-up. Dr. Niedzwiecki stressed that the management of venous insufficiency is an evolving field that interventionalists should embrace as part of their mission of offering customers a comprehensive program of quality patient care.

References
  1. Callam MJ. Epidemiology of varicose veins. Br J Surg. 1994;81:167-173. Abstract

  2. Rautio T, Ohinmaa A, Perala J, et al. Endovenous obliteration versus conventional stripping operation in the treatment of primary varicose veins: a randomized controlled trial with comparison of the costs. J Vasc Surg. 2002;35:958-965. Abstract

  3. Rosenblatt M, Burdge C, Gandhi RT. Treatment of venous insufficiency due to greater saphenous vein reflux with endovenous radiofrequency ablation. J Vasc Interv Radiol. 2003;14:S35.

  4. Rosenblatt M, Burdge C, Gandhi RT. Endovenous radiofrequency ablation of non-greater saphenous lower extremity veins to treat venous insufficiency. J Vasc Interv Radiol. 2003;14:S36.

  5. Min R, Zimmet SE, Isaacs MN, Forrestal MD. Endovenous laser treatment of the incompetent greater saphenous vein. J Vasc Interv Radiol. 2001;12:1167-1171. Abstract

  6. Min RM, Khilmani N. Endovascular laser treatment of saphenous vein reflux. Two year follow-up results. J Vasc Interv Radiol. 2003;14:S35.

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