by John C. Opie, MD, Amber Hook, MA Optima Vein Care, Scottsdale, AZ
A 38-year-old healthy male patient presented to clinic, July 2008, with multiple venous stasis ulcers of his left lower extremity. When he was 20, while working in California, he fell from a ladder and sustained a compound tibial fracture. His fracture healed, but in the process he developed a full leg deep vein thrombosis (DVT ). His DVT was not complicated with a pulmonary embolus; he did not require a caval filter, and the patient’s DVT steadily resolved on coumadin. However, it soon became apparent the resolution of the full leg DVT was associated with the malfunction of his Common Femoral Vein (CFV) valves, resulting in chronic (deep) venous insufficiency (CVI ) with the development of a fully matured post-phlebitic leg syndrome, Fig 1.
Over the succeeding years, his leg initially became swollen, heavy and then discolored. On the advice of his physicians, he wore high force 30-40-50mmHg compression hose and was advised to continue to wear them in order to prevent the development of venous stasis ulceration of his leg. As the years passed, his leg deteriorated; multiple venous stasis ulcers blossomed within 18 months of his DVT and persisted for more than 15 years. Transient healing was followed by repeat ulcer outbreaks. On multiple occasions, he attended wound care centers where he received venous stasis ulcer debridements, skin grafts, hyperbaric oxygen, antibiotics and high force compression hose. All of these failed, and he dramatically considered getting a chain saw and cutting his own leg off; he also contemplated suicide. His medical costs soared. He lived in a world of pain, odoriferous oozing wounds, embarrassment; he was unable to work for more than 15 years or wear shoes, and his social life was shattered. The ulcerations deteriorated and became difficult to manage, involving both sides of his leg and ankle. He came to our facilities for one last desperate try. We inserted a CFV monocusp, which corrected the abnormal hemodynamics, and his life changed for the better. He now is able to wear shoes, has a job, is without pain, is no longer receiving disability benefits and his social life has been restored.
Chronic venous insufficiency (CVI ) and associated chronic venous hypertension (CV H) and post-phlebitic leg syndrome (PPLS) are ancient diseases that were recorded in Eber’s Papyrus (1,500 BC). The current published incidence of CVI-CV H/PPLS in the general population ranges between 0.5-3.0%. 1-3 European data indicate that 1.5% of adults will suffer from venous stasis ulcers (VSUs) at some point during their lives.4
The calculated VSU rate is 3.5/1,000/year at >45 years of age.5 Annual CVI management costs in the United States and Western Europe, excluding an estimated 2 million workday losses, approach U.S. $2-2.5 billion.6 These costs, while variable, have been broken down to 41% drugs, 34 % hospital care, 22% district nursing, 3-13% medical fees. 6 In countries with populations exceeding 50M, some 200,000 annual hospitalizations are necessary to manage CVI . These costs generally represent about 2.6% of the total health care cost per country in any given year. About 80% of the cost is assumed by patients older than 45 years.6 Germany has published its expected ulcer management costs at €10,000 per year per patient.7 In many symptomatic CVI patients,
valvular aplasia may be more common than the previousnecropsy studies indicated, as those studies focused on asymptomatic patient limbs.8
When aplastic/dysplastic common femoral vein (CFV) valves are encountered (only identified at open-vein surgery), the surgeon currently has limited surgical options available to correct CVI . The published absence of CFV valves further discourages surgeons from surgical intervention; and that tends to direct patients into palliative care systems. The patient and the general costs of this condition indicate that failures of conservative management are common and costly. Event-free status of these medically managed patients at five years after diagnosis is essentially zero.
CVI /PPLS following DVT will often be associated with no residual reconstructable valves. Primary valve reflux (PVR ) is caused when normal valves avert and permit rest reflux, which is usually prominent with the patient lying down. They usually stop refluxing with above-valve loading, such as standing or Valsalva maneuvers. Therefore, most CVI should be evaluated with the patient lying down supine and breathing normally to include Valsalva maneuvers. A standard valve repair will usually be successful in PVR .9-10 The causes of CVI are well documented.
When valvular aplasia is encountered, surgical repair is more complicated. Artificial valves have not been generally successful. Current procedures for dysplastic/aplastic valvular CVI include an in situ prosthetic sleeve,13axillary vein transfer,14-15 segmental transfer,16cadaveric femoral vein allograft,17-18 below-the knee procedures including subfascial endoscopic perforator surgery (SEPS),19 Linton’s procedure,20 the percutaneous Dotter valve,21 and similar techniques.22A recent addition is the Maleti bicusp,23-24 which requires a thick postphlebitic vein to dissect the intima from the adventitia and is technically challenging. With nonusable valves, these procedures exhibit limited success or fail early.
The mono- cusp procedure was invented as being simple to complete and a likely long-term cure for CVI since the monocusp is “alive”(Figs 2-3). The technical details of the technique have been published previously.25-26 A cuboidal CFV entry incision is recommended to preserve monocusp conversion options if no reconstructible valves are encountered. An organized thrombus core may be encountered within the vein (Fig 2 and 1B). This material must be excised. Once the monocusp is suspended, the defect in the CFV wall is closed with an iVenae-PTFE patch (Atrium Medical). 26
This patient’s leg commenced healing within six months after monocusp implantation and was complete at two years. His ulcers have not recurred at four years and are not expected to return provided the monocusp remains competent at all subsequent follow-up ultrasounds (Fig 4).
Monocusp surgery is best described as (common) femoral vein valvuloplasty (CPT-34 501) and femoral vein patch venoplasty, or angioplasty (CPT-35286). When no valves are encountered within the common femoral veins, if the vascular approach is via a vertical incision, then little can be done for the patient’s reflux because options for monocusp cusp surgery have been surrendered. If a cuboidal CFV incision is completed and no reparable valves are found, then converting to a monocusp procedure would greatly benefit
such patients. We recommend cuboid incisions to maintain a monocusp option in all venous valve corrective surgery. It provides excellent exposure and permits monocusp conversion if no usable valve is encountered.
The patient in this case report is now without pain and his ulcers have all healed and have not recurred. His life has returned to normal. His annual medical costs have fallen from approximately $11,000/year to essentially physicianrequested DV US tracking ~ $150/year. He continues to wear compression hose, but that is mainly a personal crutch. Due the profoundly improved hemodynamics resulting from a functioning monocusp valve, he does not actually need any support hose at all. All of his distal extremity swelling has resolved. He certainly remembers his ulcer pain and does not wish to reverse down that course. His malignant venous hypertension has resolved; he has no Valsalva-induced reflux nor does he have any remaining supine rest CFV reflux. Provided his two 60 prolene sutures restraining the monocusp leading edge do not fail, his monocusp will likely last a lifetime since it is a viable structure with an intact distal blood supply and is thus able to produce NO S 111 and COX 1 vasodilatory and anti-thombotic precursors, respectively.
Monocusp surgery has the ability to reverse CVI /CV H/ post-thrombotic leg syndrome because it removes the cause (i.e., proximal continuing venous hypertension). Monocusp surgery should be covered with systemic anticoagulation and we prescribe six months of Coumadin, then convert to lifetime ASA. Contralateral surgery, if indicated, is done between five to six months after the initial monocusp implantation. Long term follow up of the group of 29 monocusp patients with 64 months indicate an 87% event-free survival (Fig 5). More detailed follow up data is available from past publications. 25 If this group is further considered, expecting an average annual cost to manage CVI from Germany is €10,000 ~$12,000 per year, then 29 patients followed event-free after monocusp surgery for >5 years; the cost savings to the local medical system in Arizona approaches $2M. From this data, it is clear that monocusp surgery, if more liberally applied, would save very large medical system costs on an annual and continuing basis. Continuing to use conventional therapy has been proven to be unsatisfactory, very expensive and prone to failures.
The patient medical costs likely never exceed $200 annually. The two events were technical errors both were corrected at return to surgery.