Monocusp Results: An Autogenous Solution for Chronic Venous Insufficiency

Abstract

Objective. Chronic venous insufficiency (CVI) has been traditionally managed with palliative care including long-duration high force compression hose, professional scheduled wound care: local ulcer management debridement/dressing, antibiotics, skin grafting, hyperbaric oxygen (HBO), Unna boot and leg elevation. This palliative care has proven expensive and is generally associated with many failures and many dissatisfied patients. Surgical intervention for aggressive CVI is uncommon at this time. However, due to the high palliative care costs and high failure rates, something new is required. Monocusp surgery was developed as a surgical option for this underserved patient group. Results. Twenty-six patients underwent 29 monocusp surgeries. Long-term follow-up showed the monocusp valves remained competent beyond 5+ years. Symptomatic failures have been rare. The VEnous INsufficiency Epidemiologic and Economic Study (VEINES) classification¹ improved over 5 years from 3.3 ± 0.9 to zero (p

VASCULAR DISEASE MANAGEMENT 2010;7(10):E204–E209

Key words: varicose veins, monocusp, chronic/central venous insufficiency, ulcer, iVena™

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Introduction

Chronic venous insufficiency (CVI) was recorded in the Eber’s Papyrus (1,500 B.C.). The incidence of CVI in the general adult populations ranges between 0.5 and 3.0%.^3–5 European data indicate that 1.5% of adults will suffer from a venous stasis ulcer (VSU) at some point during their lives.⁶ The calculated VSU rate is 3.5/1,000/year at > 45 years of age.⁷ Annual CVI management costs in the United States and the United Kingdom, excluding an estimated 2 million workday losses, approach U.S. $1.6 billion.^8–10 In symptomatic CVI, valvular aplasia may be more common than the previous necropsy studies indicate, as those studies focused on asymptomatic patient limbs.¹¹ When aplastic/dysplastic common femoral vein (CFV) valves are encountered (only identified at open-vein surgery), the surgeon currently has severely limited surgical options available to correct CVI. The causes of CVI are well documented.^12,13 In primary valve reflux (PVR), the CFV valve leaflets appear normal, but evert with afterload and reflux.¹⁴ PVR can be repaired using standard preferred techniques.^15,16 Current procedures for dysplastic/aplastic valvular CVI include an in situ prosthetic sleeve,¹⁷ axillary vein transfer,^18,19 segmental transfer,20 cadaveric femoral vein allograft,^21,22 below-the-knee procedures including subfascial endoscopic perforator surgery (SEPS),²³ Linton’s procedure,²⁴ the percutaneous Dotter valve²⁵ and similar techniques.²⁶ A recent addition is the Maleti bicusp,²⁷ which requires a thick postphlebitic vein to dissect the intima from the adventitia and is technically challenging (Dalsing²⁸ reports Maleti’s operation encountered 2 early deep vein thromboses [DVTs] and 1 occlusion with the advent of oral contraceptives in 18 surgical patients, providing a 16.6% complication rate). With nonusable valves, these procedures exhibit limited success or fail early. We present a new surgical method to replace a dysfunctional aplastic/dysplastic/absent venous valve using the full-thickness viable native vein-wall tissue (the monocusp), and covered the resulting defect with a specially designed ultrathin, highly compliant, synthetic, expanded polytetrafluoroethylene (e-PTFE) vascular closure patch (iVena, Atrium Medical, Corp., Hudson, New Hampshire) to successfully reverse CVI, both early and long term, with minimal complications. The technique is described in a preceding short paper³⁷ (Figures 5–8).

Materials and Methods

Identification of patients. This study was launched in 2003 and included symptomatic CVI patients. A total of 500 patients were screened for venous disease, and 29 monocusp procedures were completed in 26 patients and were closely followed, providing an aggressive CVI incidence rate of 5.2% in venous patients. Three patients requested bilateral operations. We do document CFV reflux more often than the above number, but in many situations, it is mild and without symptoms. We continue to monitor these patients, and should they develop aggressive symptoms, surgery may become an option. The remaining 473 patients received appropriate treatment for superficial venous reflux including endovenous laser treatment (EVLT) and/or ultrasound-guided sclerotherapy. Our facility has found ultrasound-guided endovenous chemical ablation (USG ECA) to be sufficiently effective as to not require ambulatory phlebectomies. Commonly identified preoperative causes of CVI were trauma (long bone fractures) complicated with DVT, or prolonged sitting followed by aggressive CVI after the DVT resolved. The inclusion criteria were: (i) documented aggressive CVI with unusable valves; and (ii) failed surgery or failed past conservative therapy — extended 40–50 mmHg compression hose, ulcer debridement/dressing, multiple failed skin graftings, Unna boots, wound-care treatments, hyperbaric oxygen (HBO), etc. The duration of CVI symptoms and multiple treatment failures varied from 3–10 years. It was not standardized due to referring physician variability. Several patients were reviewing below-the-knee (BTK) amputations, with 1 actually scheduled. This BTK surgery was stopped in favor of a monocusp, and the amputation was no longer indicated. Five years later, the patient has a useful leg and no CVI issues. His monocusp is competent. Palliative care was not continued; it was converted to definitive surgical treatment due to the fact that the referral was made for that reason. Patients were informed of the benefits, risks and outcomes of monocusp surgery.

Doppler/Duplex Analysis

Duplex venous ultrasound documenting the presence or absence of CFV reflux and distal leg veins was performed using several imaging systems: Phillips HDI (Philips Healthcare, Andover, Massachusetts), Siemens Healthcare (Malvern, Pennsylvania), Terrason (Burlington, Massachusetts) or an Esaote MyLab25 (Biosound Esaoate, Inc., Indianapolis, Indiana). Early series duplex follow-up results ( 5 years was scored by procedure-unblinded physicians. (The unblinding was due to the fact that the team who had performed the surgeries were also vascular duplex trained and did their own duplex readings rather than sending the patients out to a vascular lab in the later follow-up.) Six venous segments were examined: 1) CFV; 2) femoral vein (FV); 3) profunda and greater saphenous vein (GSV) in the upper thigh; 4) popliteal; 5) posterior/anterior tibial; and 6) peroneal veins in the calf. Measurements were taken supine, 45° or upright with leg compressions and/or Valsalva maneuvers.^25,29,35 CFV and popliteal vein data were considered representative of the pathological and corrected venous physiology. Reflux > 0.5 sec was considered pathological and was arbitrarily scored from 0 to 4, with 0 = nonexistent; 1 = mild, 25% of the duration of the test period; 2 = moderate, 50%; 3 = considerable, 75%; 4 = severe, 100%. Such reflux is readily apparent on duplex appearing above the null line as ultrasound noise (spectral analysis), indicating flow reversal during some or all of the test period. Venous duplex evaluations were performed intraoperatively before and after monocusp implantation and at 3, 6, 12, 24, 36, 48 and 60 months postoperatively, and periodically in between, as such arrangements fit patient schedules. Pre- and post-surgery severity of venous disease was assessed using the guidelines set forth by the CEAP³⁰ classification and the VEINES Task Force.^9,31,32 Venograms were completed in 5 patients (17.2%), when indicated, to exclude leg vein outflow obstructions, map chronic DVTs, and in patients with known FV caliber abnormalities, when or if this information could not be reliably established by long-axis B-mode duplex ultrasound. Pre- and post-operative assessments were made with the aid of venous duplex ultrasound. Monocusp surgery rationale. Most existing surgical options for CVI either fail or provide limited success. Something new is required. Technical details are presented in the technique manuscript and previous publications (Figures 5–8).^37,38Statistical analysis. Baseline duplex data, VEINES9,31 and the CEAP³³ scores were compared with individual mean follow-up times and were analyzed by the Student’s t-test and expressed as mean ± standard deviation; p Results During the study period, 500 patients presented with symptomatic venous disorders. Work-up showed severe CVI in 26 patients (5.25%), bilateral in 3. The remaining patients exhibited superficial venous disorders only and were excluded. Basmajian’s¹¹ autopsy specimens reported that non-selected patients will have absent CFV valves in 21% of cases. All 26 CVI patients exhibited irreparable valves (29 surgeries) and aggressive disease. Fifty-two paired limbs were included in this series. Before surgery, all symptomatic patients had > 0.5 sec reflux. The symptoms resolved following successful monocusp implantation (Figure 1). CEAP33 grading of all patients, with one exception, were CEAP 4 or 6. CEAP classifications2 improved from grades 4–6 to 0–1 (CEAP use after surgical intervention is limited by C5 classification). CVI was well controlled following monocusp surgery (Figure 1). All patients showed evidence of prolonged clinical improvement. The VEINES class decreased from from 3.3 ± 0.9 (unable to work) to 0 (Figure 2). VEINES uses a grading of 1–3, which is imputed from the SF-36 (Short Form-36 Questionnaire), based on the Likert scale.²⁸ There were no surgical fatalities. One DVT occurred (multiple-stented May-Thurner’s syndrome) after subtherapeutic (INR 1.3) postoperative warfarin discharge. This patient was readmitted, heparinized and the DVT, resolved but the monocusp became adherent. She returned at 2 years for re-do monocusp surgery due to recurrent symptoms. Her re-do surgery was successful, and she developed a second DVT, which was resolved with heparin, and she was discharged fully anticoagulated. No late DVTs occurred during 5 years of follow-up after the warfarin was discontinued (at 6 months) and substituted with 81 mg acetylsalicylic acid daily. No postoperative patients complained of their preoperative symptoms with a functioning monocusp and all appeared satisfied with their procedure(s). All chronic active VSUs (n = 15) resolved without recurrence between 2 and 5 years. One patient had a recurrent ulcer in a different location (lateral ankle vs. interdigital). His monocusp remains competent. He had developed extensive secondary venous reflux in accessory leg veins. This was managed with effective USG ECA. Further monitoring of this pilot study group is ongoing.

Discussion

Successful monocusp operation was defined as: 1. The ability to construct a monocusp with a viable autologous vein wall without major complications with immediate resolution of CFV reflux (Figure 4). 2. Measurable improvement in the patient’s quality of life (QoL) (Figure 2). 3. Sustainment, reduction or absence of venous reflux (Figure 1). By these criteria, we conclude that the monocusp operation is feasible, safe, durable and reliably reverses CVI in the absence of a usable/repairable valve, with minimal complications over the long term. Site of repair. The decision to repair CVI at the CFV is based upon: 1. The reflux was detected at the CFV. It is therefore logical to attempt to correct it there rather than distally. 2. The CFV is the largest vein in the leg, and vascular surgeons are familiar with the exposure. 3. The CFV is above the profunda vein. Therefore, controlling the reflux above the profunda will either control profunda reflux, or at least minimize it. It is apparent to the authors and to informed readers familiar with venous valve surgery that monocusp surgery results are significantly better than previous publications with respect to the results of conventional or unconventional valvular repair — Raju, Kistner, Maleti, and so forth. An 87% event-free survival rate at 5 years (Figure 3) is not previously reported in CVI where failures are the norm. Clearly, a monocusp conversion is not practical if the more typical single vertical incision is made in the anterior CFV wall, hence the adoption of the cuboid incision in all attempted CFV valve repair surgeries (Figure 7). If usable valves are found, then direct valve repair remains the surgery of choice, since anticoagulants are less critical. Monocusp/e-PTFE vascular patch. The competent, full-thickness viable monocusp with an intact endothelium described in this work has provided durable, low thrombogenic control of CVI for at least 5 years in this series. Because the monocusp valve is constructed with viable vascular tissue with its own intact blood supply, delayed valve necrosis/failure is not expected unless 6–0 prolene suture failure or monocusp patch adherence occurs with the monocusp left open. When the valve closes, the convex incisions forming the periphery of the rounded monocusp will extend to the shape of the patent tubular vein and limit peripheral reflux. Although there is the potential for peripheral reflux in practice, it is minimal on postoperative duplex examinations. Potential complications. Infection is a potential complication, as the patch cannot often be easily explanted in debilitated patients. Therefore, intravenous prophylactic antibiotics are recommended with all venous monocusp procedures, followed with 1 week of oral antibiotics. Close the subcutaneous tissues and skin in multiple layers. A wound breakdown here will be difficult to manage with the underlying prosthetic patch exposed and connected to the venous bloodstream. Postoperative DVTs have not been an issue with therapeutic postoperative warfarin for 6 months and conversion to long-term aspirin. Delayed fracture or disintegration of the two leading prolene sutures may render the valve incompetent, possibly leading to the delayed return of CVI. This has not occurred with the longest follow up periods now exceeding 5 years. Reentry venous surgery is always possible, but operating on this scarred area must be done cautiously. Postoperative bleeding following systemic heparinization necessary for venous monocusp construction is unlikely to be bothersome. Protamine is not recommended once the CFV is unclamped if all surgical bleeding is controlled. Presently, the authors recommend completing a GSV EVLT for GSV reflux in patients with CVI before proceeding with monocusp surgery. The monocusp could adhere to the inside surface of the e-PTFE patch. This occurred in 1 patient who underwent successful proximal re-do monocusp surgery. This can be avoided by keeping the leading-edge sutures, and therefore the monocusp, short of the patch.

Conclusions

In this study, 26 patients who presented with severe CVI underwent 29 monocusp operations with unusable CFV valve tissue. Conventional direct or indirect deep-vein valvuloplasty procedures are not always successful and may lead the surgeon to confine any surgical procedure to superficial venous structures only. There is a published 2-year 30–40% varicose vein recurrence rate quoted for stripping and ligation (S&L) procedures,^34,35 which is more common when CVI issues remain unresolved. EVLT and radiofrequency ablation technologies have been developed and are widely used in superficial disease. Few surgeons currently attempt to correct CFV reflux due to unfamiliar surgery and the problem of encountering irreparable valves and the lack of a repeatable, reliable procedure combined with DVT and pulmonary embolism (PE) concerns. Our series did not encounter PE or DVT with 6 months of warfarin, which provided INR values that were therapeutic, and conversion to long-term aspirin after 6 months. The 5-year event-free CVI survival rate of 87% (Figure 3) is promising, but needs further elaboration. Ambulatory venous pressures were not available at our institution. The accuracy of venous duplex seems to be well-suited to objectively and repetitively assess the results of monocusp surgery. Monocusp surgery is designed to treat symptomatic CVI in the absence of a repairable valves using local full-thickness viable vein-wall tissue to create the monocusp. The operation is described as a CFV valvuloplasty (34501) and patch repair of a CFV venotomy (35286). The authors acknowledge that the monocusp is new, and the series is limited and is not elsewhere reported by other investigators. It is expanding. Long-term and larger-volume follow-up will be necessary to further evaluate the potential of monocusp operations. Five-year follow-up results in this series are encouraging, and all patients expressed satisfaction. Monocusp surgery could be further evaluated in the laboratory by implanting a monocusp in a rabbit jugular vein and analyzing the short- and long-term histology and biochemistry. The first monocusp publication appeared in Phlebology.³⁷ An online discussion about new valvular technologies was published in Angiologie.³⁸

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From Optima Vein Care/Alliance Cardiac Surgery, Chandler, Arizona, and *Arizona State University, Tempe, Arizona and Scottsdale Medical Devices, Inc., Scottsdale, Arizona. Disclosures: Dr. John Opie invented and patented the monocusp procedure: USPTO: 2005273159: Monocusp valve construction and defect closure device for deep vein regurgitation. SMD has a royalty arrangement with Atrium Medical Corp. to produce and market the iVena e-PTFE ultrathin vascular patch. Dr. Opie also founded and has a fiduciary interest in Scottsdale Medical Devices, Inc., as does Mr. Izdebski. Manuscript submitted April 28, 2010, provisional acceptance given July 13, 2010, final version accepted July 30, 2010. Address for correspondence: John C. Opie, MD, Optima Vein Care/Alliance Cardiac Surgery Ltd., Chandler, AZ 85258. E-mail: jopiemd@aol.com