Ganguli et al. Minimally Invasive Vein Care
I n t e r v e n t i o n a l R a d i o l o g y • Pe r s p e c t i v e
Establishing an Outpatient Clinic for Minimally Invasive Vein Care Suvranu Ganguli1 Jacques C. Tham Bertrand M. Janne d’Othee Ganguli S, Tham JC, Janne d’Othee BM
OBJECTIVE. Minimally invasive vein care procedures are less invasive than surgery and have a lower complication rate, are well tolerated by patients, and have good cosmetic results. Because radiologists have expertise in imaging-guided procedures, offering minimally invasive vein care is a logical step. CONCLUSION. Starting an effective outpatient vein care clinic involves decisions about space, equipment, and advertising. With proper staffing and rapport with patients and referring physicians, a varicose vein practice can be a profitable adjunct to any radiology practice. nterest in imaging-guided minimally invasive endovenous ablation techniques in the management of lower extremity venous insufficiency is growing rapidly. Establishing a successful outpatient clinic for minimally invasive vein care can be relatively easy with the benefit of background information and tips such as those we describe. Endovenous ablation is replacing conventional vein-stripping surgery as the first therapeutic option for incompetent greater saphenous veins (GSVs) and lesser saphenous veins. Both laser ablation and radiofrequency ablation have had excellent long-term results and lower recurrence rates than those reported for surgical stripping [1–10]. With ablation techniques, refluxing venous segments are closed by endoluminal catheter-directed heating. Clear advantages of endovenous ablation techniques over surgical stripping include shorter and milder discomfort and bruising after the procedure, earlier return to normal activities, and avoidance of peridural and general anesthesia [8, 9, 11]. Endovenous ablation can be coupled with other minimally invasive techniques, such as sclerotherapy and microphlebectomy, in an outpatient clinic to manage side branches associated with lower extremity venous insufficiency. Strategic aspects of starting a clinic include mastering the techniques of minimally invasive vein care and knowing the role of the procedures, designing the space, purchasing equipment, and staffing. Operating the clinic entails patient recruitment and methods of reimbursement.
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Keywords: endovenous ablation, interventional radiology, lower extremity, percutaneous ablation, vascular imaging DOI:10.2214/AJR.06.0836 Received June 25, 2006; accepted after revision November 21, 2006. 1All authors:
Department of Radiology, Beth Israel Deaconess Medical Center, Harvard Medical School, 330 Brookline Ave., Boston, MA, 02214. Address correspondence to S. Ganguli (
[email protected]).
AJR 2007; 188:1506–1511 0361–803X/07/1886–1506 © American Roentgen Ray Society
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Minimally Invasive Vein Procedures Removal of varicose side branches without simultaneously controlling reflux in the main trunk of the GSV or lesser saphenous vein invariably results in recurrence of symptomatic varicosities [12]. Endovenous ablation of the GSV is focused on managing reflux in the main incompetent vessel rather than in the visible varices (i.e., controlling the cause of the problem rather than its consequences) (Fig. 1). Instead of removing an incompetent GSV as in conventional surgical stripping, endovenous ablation techniques close refluxing venous segments by endoluminal heating under direct sonographic guidance. Endoluminal heating causes venous spasm, endothelial damage, and inflammation in the vessel wall. Heating of the vein wall to sufficient temperatures causes collagen contraction and fibrosis of the vein [3, 13], rendering the vein almost invisible on subsequent follow-up sonograms. Sclerotherapy, ambulatory stab phlebectomy (microphlebectomy), and transcutaneous laser treatments are useful adjunct techniques used primarily to control side branches, including building varicosities, small reticular veins, and spider veins (telangiectasia). Side branches should be managed at endovenous ablation or after successful cessation of truncal reflux; otherwise, recurrences are to be expected. Visualizing the exact pathway of venous reflux on an initial duplex sonogram is the key to successful treatment [14] (Fig. 2). Larger varicosities are well suited for phlebectomy, but sclerotherapy, with or without sonographic guidance, also can be used [15–17]. Many vein care practices rely solely on sclerotherapy for such treatments.
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Minimally Invasive Vein Care
A
B
Fig. 1—48-year-old man with symptomatic lower extremity venous reflux. A, Photograph shows medial aspect of left thigh before endovenous laser ablation. No direct intervention (e.g., sclerotherapy or microphlebectomy) has been performed on varices (arrow). B, Photograph 1 week after endovenous laser ablation shows improvement, including disappearance of varices (arrow), due to occlusion of greater saphenous vein and cessation of reflux.
Minimally invasive vein techniques are relatively safe to learn and perfect. A detailed description of minimally invasive vein care techniques [9] is beyond the scope of this article. We have found, however, that gaining access to a dilated varicose vein is easier than gaining access to a nondilated peripheral vein for placement of a central catheter, a technique with which most radiologists are familiar. Starting an Outpatient Vein Care Clinic Minimally invasive vein care is a unique opportunity to develop a practice that integrates clinical, duplex sonographic, and endoluminal skills for venous ablation and applies new techniques (sclerotherapy, ambulatory phlebectomy) to manage residual veins during followup visits. Radiologists have expertise in imaging-guided procedures, which makes minimally invasive vein care a logical step. These
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techniques require no injection of iodinated contrast medium or irradiation, benefiting both patient and operator. The risks of these procedures are extremely low. There is no requirement for surgical backup because there is no risk of acute extremity ischemia as in arterial interventions, which makes an outpatient setting for these practices logical. Clinic Space The physical layout of the outpatient clinic is an important initial decision. The reception area is central to the outpatient office and requisite for providing a favorable impression to patients. Established radiology practices often have reception, scheduling, and patient waiting areas, which can easily be incorporated into the needs of the vein care clinic. A free-standing vein care clinic also can be undertaken but usually requires more planning than does adding vein care to an established radiology practice.
The most important space needed for a minimally invasive vein care clinic is a dedicated procedure room (Fig. 3) for endovenous ablation and sclerotherapy. A well-designed room has enough space for a procedure table, ideally one that can tilt; a sonography unit; and the ablation system. Sufficient lighting that is easily controlled and a scrub sink also are essential. Having enough room to store supplies (e.g., gloves, gowns, bandages, compression stockings, and procedure kits) in the room is beneficial because such materials often are needed during procedures. The approximately 13 × 10 foot (4 × 3 m) procedure room in our clinic has proved adequate. Other details to address include removal of contaminated trash, connection to a PACS, and a system for dictation and transcription of imaging reports and consultation and procedure notes. A second procedure room usually is not needed unless a second ablation system will be in use. However, a separate clinic room for consultations and follow-up visits is essential. The procedure room can be used for examinations and consultations between procedures, but occupying the procedure room with clinic visits is not recommended. Having separate rooms allows a nurse practitioner or physician assistant to examine and consult with one patient while the radiologist performs ablation on another. In addition, simpler vein care procedures such as sclerotherapy can be performed in the smaller clinic room as needed. Equipment Determining which equipment to purchase can be one of the most important decisions in starting a vein care clinic. Decisions include selection of a sonography unit, a laser or radiofrequency ablation system, and phlebectomy hooks. At minimum, a handheld portable duplex sonography unit is required at the cost of approximately $20,000. However, a higher-quality sonography unit already within an established radiology practice can be used. Investing in a digital camera with photographic archiving and printing capabilities can be helpful for documentation at consultations and follow-up visits. Many ablation systems are available (Table 1), and thorough research is needed before purchase. General costs of endovenous ablation systems range from $35,000 to $40,000. Several vendors have leasing arrangements that can benefit smaller practices. An initial decision must be made between endovenous laser ablation and radiofrequency ablation. The two techniques have similar success
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D
E
F
Fig. 2—Lower extremity vein maps. Because of high variability in venous anatomy and presence of multiple possible side branches, drawings are preferred over physical descriptions of anatomic features. Arrows indicate direction of reflux within incompetent veins. Maps are drawn during initial sonographic examination and are used to facilitate explanations to patients at initial consultation and during follow-up. A, Map of truncal greater saphenous vein reflux. B, Map of greater saphenous vein and branches. C, Map of anterior branch of greater saphenous vein. D, Map of anterior branch and greater saphenous vein. E, Map of perforator and greater saphenous vein. F, Map of vein of Giacomini.
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Minimally Invasive Vein Care Fig. 3—Photograph shows physical layout of clinic room used for minimally invasive venous ablation. Essentials are procedure table, sonography unit, and room for supplies and laser ablation system.
TABLE 1: Vendors and Websites for Endovenous Ablation Systems System Type
Manufacturer
Website
Laser
AngioDynamics
www.angiodynamics.com
Laser
Biolitec
www.biolitec.com
Laser
Diomed
www.diomedinc.com
Laser
Dornier MedTech
www.dornier.com
Laser
Vascular Solutions
www.vascularsolutions.com
Radiofrequency
VNUS Medical Technologies
www.vnus.com
TABLE 2: Advantages and Disadvantages of Clinic Staffing Strategies Staff Member Administrative assistant
Advantages
Disadvantages
Has lower salary (≈ $35,000/y) than a physician assistant
Has no medical training
Understands reimbursement and preprocedural approval strategies
Does not provide clinical services or perform procedures Has gradual learning curve in understanding the pathophysiologic mechanisms of disease and vein care, which limits ability to answer questions from patients and referring physicians
Physician assistant, Has greater medical knowledge, Has higher salary (≈ $70,000/y), the cost of nurse practitioner which can lead to greater autonomy two administrative assistants Consults with patients and conducts follow-up independently Performs procedures with minimal supervision Performs administrative duties in addition to clinical responsibilities Performs duties that can help in radiology practice, such as monitoring IV contrast injections
and complication rates, and the technique chosen is clinic and practice specific. There are practical advantages of laser ablation systems over radiofrequency ablation systems. Laser ablation is more effective than radiofrequency ablation in cases in which the GSV diameter is greater than 20 mm. Endovenous laser ablation also is considerably faster to perform than radiofrequency ablation. For example, a length of
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vein treated with radiofrequency ablation in 20–30 minutes can be treated with laser ablation in only 2–3 minutes. Laser ablation systems also use smaller access sites (4 French for laser vs 6–8 French with radiofrequency). Last, the single-use endovenous probe kits needed for radiofrequency ablation cost twice as much ($700) as laser ablation kits ($350), although this cost difference is decreasing.
The medical laser systems used for endovenous treatments are class 4 lasers that operate in the near-infrared region of the electromagnetic spectrum at output power of up to 15–30 W. Safe handling of these devices is regulated. The American National Standards Institute [18] has published a comprehensive document on the issues and a set of guidelines. Appropriate eyewear and training for laser use should be provided by manufacturers as part of the sale and are necessary for compliance with state and federal regulations. Ambulatory phlebectomy is a minimally invasive technique performed with the patient under local and tumescent anesthesia with or without IV conscious sedation. Specialized hooks are used to remove superficial varicose veins through small skin incisions (1–3 mm) [19]. Many companies provide a wide selection of hooks. Choice of size, curvature, and sharpness depends on physician preference (e.g., right- vs left-handedness) and the specific situation. Having an array of hooks may be helpful but is not necessary. Phlebectomy hooks cost approximately $500 each and can be repeatedly sterilized for multiple uses. Clinic Staff A successful minimally invasive vein care clinic requires knowledgeable and effective support staff. Staff tasks include answering questions from referring physicians and patients, completing paperwork for preprocedural approval and reimbursement from insurance companies, seeing patients for new consultations and clinical follow-up, and performing procedures under physician supervision. The support staff also provides continuity between clinic and patient. The staff is integral when rotating physicians work in the clinic and on days the clinic does not have scheduled procedures or patient visits. Possibilities for support staff include an administrative assistant and a physician assistant or nurse practitioner. There are advantages and disadvantages to each type of support staff (Table 2). Operating the Clinic Advertising Advertising and marketing are important components to establishing a minimally invasive vein care clinic. An effective initial way to promote a clinic is to create both an informational Website (e.g., www.massveincare. com) and a pamphlet for the clinic. The pamphlet can be sent to or placed in referring physicians’ offices with links to the Website for more information. Educational luncheons or dinners
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Ganguli et al. can be used to inform potential referring physicians about the availability of and services offered by the clinic. Another simple way to advertise is to join a vein care association such as the American College of Phlebology (www.phlebology.org) or the Society of Interventional Radiology (www.sirweb.org). Professional associations are a beneficial source of information and can link the clinic profile, telephone number, and Website to their Websites, increasing exposure and referrals. Newspaper advertisements, television commercials, radio commercials, billboards, and mailers are ways to reach larger audiences of patients directly. Marketing representatives in these media have information on audiences and costs. Target audiences for direct patient advertising should represent the population in which lower extremity venous insufficiency is prevalent, that is, women 30–60 years old. Independent companies can be hired to promote the clinic and arrange advertising. The benefits of advertising can be striking because varicose veins are an extremely common problem, and many patients and physicians are unaware of the treatment possibilities. For example, our clinic advertised with a 1minute radio commercial for 4 weeks on three local radio stations. The cost was approximately $100–$150 per 1-minute advertisement (as high as $600 in peak hours), which amounted to $40,000–$60,000 for the month. The commercials generated more than 300 interest calls from patients and had to be pulled before the fifth week because of the overwhelming response. Rapport with Patients and Referring Physicians An attractive aspect of outpatient minimally invasive vein care relates to interactions with patients and establishing patient–physician relationships. Most patients are 30–70 years old and are interested in controlling their condition. Because these procedures are elective, patients have often explored the Internet about the condition and learned about therapeutic options. Clinical staff can expect discussion with and cooperation from patients, which can lead to the development of long-term pleasant patient–physician relationships. This rapport requires that early in the relationship patients be given clear and detailed explanations of a few important concepts. In our practice, a staff member obtains the initial duplex sonogram and draws a map of the venous circulation and direction of reflux (Fig. 2). This diagram is used to explain the mechanism of the patient’s condition and
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the rationale for treatment. Two additional concepts are emphasized during the initial clinical encounter: First, varicose veins are a chronic problem that often requires several steps of treatment. Second, it is reasonable to expect symptom relief, but it is hazardous to expect complete disappearance of varicosities and a perfect appearance. During follow-up visits, patients may have forgotten what varicosities looked like before treatment. Taking pictures before treatment is recommended for documentation. Establishing rapport with patients and referring physicians is essential to a successful clinic. A direct telephone number and answering machine are needed for the clinic, and calls from patients and referring physicians must be returned in a timely manner. A well-designed informational Website is important in portraying a competent and professional clinic. A minimally invasive outpatient vein care clinic can expand the referral base for the rest of the radiology practice (diagnostic imaging and hospital-based interventional radiology procedures) by building good relations with local physicians and patients. Scheduling thorough follow-up for each patient helps establish rapport. A typical patient experience includes a consultation before the procedure; a telephone call the day after the procedure; and follow-up clinic visits with sonography 1 week, 3–6 months, and 1 year after the venous ablation procedure. Each patient visit should be accompanied by a prompt, appreciative, and informative consultation or follow-up letter to the referring physician. A successful clinic provides minimally invasive vein care techniques such as ambulatory phlebectomy and injection sclerotherapy on follow-up visits. When all minimally invasive vein care techniques are offered, patients can conveniently undergo all treatments in the same clinic rather than being referred elsewhere. Another strategy is to develop a business alliance with other vein care specialists, especially dermatologists, who can provide a referral base for endovenous ablation and provide sclerotherapy to patients who need it. This association can be especially helpful at the start of a practice focused on endovenous ablation (the more familiar technique to the radiologist); experience can be acquired before sclerotherapy and phlebectomy are incorporated. Reimbursement An outpatient vein care clinic can be a monetarily advantageous addition to an estab-
lished radiology practice. Unlike services performed in hospital-based radiology practices, which are billed in professional and technical components, an outpatient ablation procedure, the related consultation, and follow-up visits can be billed globally. It is advantageous that all revenue come to the physician group rather than being split between the physician group and the hospital. The Current Procedural Terminology codes [20] were conceived to favor performance of endovenous ablation in an outpatient office rather than in a hospital. This policy is logical given the safety, minimally invasive nature, and short duration (typically < 2 hours) of the procedures. According to the Centers for Medicare and Medicaid Services [21] in January of 2005, endovenous ablation of an incompetent vein inclusive of all imaging guidance and monitoring had a national average reimbursement of approximately $2,100 for procedures performed in the office setting and $370 in the hospital setting. Treatment of second and subsequent veins in a single extremity had average national reimbursements of approximately $440 and $180 in the office and hospital settings, respectively. Insurance companies reimburse for minimally invasive vein care only if the procedure is performed for medical—that is, not purely cosmetic—purposes. Medical necessity can be documented on the basis of symptoms and duplex sonographic evidence of substantial reflux (duration, > 0.5 second). Symptoms associated with lower extremity venous insufficiency include leg pain, fatigue, heaviness, itching, burning, cramps, restless legs, swelling, ulceration, and hemorrhage. Most insurance companies do not require approval before a procedure, but it is important to learn which providers do require preapproval and to establish a system for obtaining preapproval with International Classification of Diseases and Current Procedural Terminology codes (Table 3). Conclusion Endovenous ablation techniques have clear advantages over surgical stripping in the management of lower extremity venous reflux disease. Because they have background and experience in imaging-guided procedures, radiologists are well suited for participation in minimally invasive vein care. Because local anesthesia is used, the procedures can be performed relatively easily in an outpatient setting. Setting up a clinic involves preliminary decisions about work space, equipment, and support staff. Successfully operating a clinic
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Minimally Invasive Vein Care TABLE 3: International Classification of Diseases and Current Procedural Terminology Codes for Varicose Vein Management Procedures Code
Diagnosis
International Classification of Diseases, ninth revision 459.81
Chronic venous insufficiency
454
Varicose veins with ulcer
454.1
Varicose veins with inflammation
454.2
Varicose veins with ulcer and inflammation
454.8
Varicose veins with other complications (pain, swelling, edema)
454.9
Varicose veins, not otherwise specified (venous incompetence)
729.5
Pain in limb (without mention of varicose veins)
729.81
Swelling of limb (without mention of varicose veins)
782.3
Edema
Current Procedural Terminology 36478
Endovenous ablation, first vein
36479
Endovenous ablation, subsequent vein(s) in same leg
involves advertising, communication and rapport with patients and referring physicians, and optimization of reimbursement. In addition to being a monetarily advantageous endeavor, an outpatient vein care clinic can expand the general practice referral base for diagnostic imaging and hospital-based interventional procedures.
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