Valve reconstructions

Abstract

The history of venous valve reconstruction extends back to 1968 when Robert L Kistner performed the first internal valve plasty to treat deep venous axial reflux. Throughout the past 50 years other techniques of reconstructive deep venous surgery (RDVS) were developed, not only to repair but also to replace venous valves. And the fact that several surgeons and centers have undertaken RDVS in the treatment of chronic venous insufficiency (CVI) reporting outcomes, has added knowledge to define more clearly the role of this kind of specialized surgery. Patients who may benefit from RDVS are among those where conventional treatment with compression stockings combined with superficial surgery has failed. Ulcer-healing rates of up to 70% have been reported after RDVS and ulcer-free periods of up to 36 months have been generated. But during five-year follow-up, freedom from ulceration period and clinical improvement rates were reduced significantly. This raises then the issue and challenge of durability of RDVS since the average age of patients who can benefit from it is about 50 years.

Keywords

Venous reconstruction venous reflux

Introduction

Chronic venous insufficiency (CVI) represents a great and complex health problem with social–economical and individual consequences. The more serious condition in CVI is the development of a venous ulcer, which has an estimated prevalence of 0.1–1.0%.¹ Approximately 2% of the total healthcare budget in western countries is used in the care and treatment of venous leg ulcer patients.^2–4 For the individual patient this condition can represent a significant reduction in the level of quality of life that compares equally to patients with cancer and heart failure, and inferiorly to those with other chronic conditions like diabetes mellitus and arthritis.^5–7

The conventional treatment of CVI with compression stockings combined with superficial surgery seems to improve venous hemodynamics, but only achieves 65% ulcer-healing rate after 24 weeks and the recurrence rate is 12% per year.⁸

Superficial and perforator reflux is abolished by excision/ligation/ablation of the affected veins, while deep venous reflux represents a major challenge, since it requires either repairing or replacing the valve structure to regain function.

The history of venous valve reconstruction extends back to 1968 when Robert L Kistner performed the first internal valve plasty. The same author described the transposition in 1979 and the external or trans-commisural technique in 1990, all three techniques aimed to treat axial reflux in primary chronic venous insufficiency (PCVI).^9–11

Secondary chronic venous insufficiency (SCVI) poses a different surgical challenge. The valve leaflets that have been damaged after an episode of deep venous thrombosis (DVT) need to be replaced. Taheri and Raju reported the first series of autologous venous valve transplant from the brachial and axillary vein to correct post-thrombotic reflux.^12,13 Maleti and Lugli introduced a technique of constructing new valves taken advantage of the post-thrombotic thickening of the vein wall.¹⁴ Throughout the past 50 years more surgeons and centers have undertaken reconstructive deep venous surgery (RDVS). Several papers have reported outcomes after RDVS and have added knowledge to be able to define more clearly the role of this kind of specialized surgery in the treatment of CVI.

Basically the aim of RDVS is to reduce high levels of ambulatory venous pressure (AVP) by correcting axial deep venous reflux.

There is a lack of epidemiological data regarding the number of patients who would benefit from RDVS. But they are among those patients where conventional treatment has failed.

Clinical evaluation

The framework to categorize CVI according to the clinical presentation, etiology, anatomy, and pathophysiology is provided by the clinical–etiology–anatomy–pathophysiology (CEAP) consensus classification, which has been exhaustively addressed in several publications in the last years. The use of the Venous Clinical Severity Score (VCSS) is recommended to quantify the severity of the disease and the outcome after intervention (Table 1).^15,16

Table 1.

Venous Clinical Severity Score (VCSS).

Attribute	Absent = 0	Mild = 1	Moderate = 2	Severe = 3
Pain	None	Occasional	Daily	Limit activities
Varicose veins	None	Few, scattered	Multiple (LSV)	Extensive (LSV, SSV)
Venous edema	None	Evening, ankle	Afternoon, leg	Morning, leg
Pigmentation	None	Limited area	Wide (lower 1/3)	Wider (above 1/3)
Inflammation	None	Cellulitis	Cellulitis	Cellulitis
Induration	None	Focal (<5 cm)	<Lower 1/3	Entire lower 1/3
Number of AC	0	1	2	3
Duration of AC	None	<3 months	3 months–1 year	>1 year
Size of AC	None	<2 cm diameter	2–6 cm diameter	>6 cm diameter
Comp therapy	Not used	Intermittent use	Most days	Continually

LSV: long saphenous vein; SSV: short saphenous vein; AC: active ulceration; lower 1/3: lower 1/3 of the leg.

Investigations

The work-up of patients to be considered for RDVS includes a combination of hemodynamic and imaging techniques.

color duplex ultrasound (CDU);

AVP measurement;

trans-femoral venography (ascending and descending);

magnetic resonance (MR) venography.

Hematological assessment is also mandatory since about 55% of patients with SCVI have a hereditary thrombophilia.

Color duplex ultrasound

CDU evaluates axial reflux in the different anatomical segments of each venous system. The examination is performed with the patient standing, weight bearing primarily on the contra lateral limb. A 12 cm wide pneumatic cuff is placed distally to the segment to be examined, and connected to a venous compression unit, which enables very fast (<0.2 s) inflation and deflation. The inflation pressure is adjustable, and set at 150 mmHg. The venous compression unit ensures a standardized repeatable venous reflux procedure (inflation of the cuff, sustained for 3 s and then deflated), which in our opinion to a larger degree mimics venous reflux than the commonly used Valsalva maneuver. By the latter, distal pathology may be masked by a proximal patent valve, and in some elderly patients the effect of the maneuver is reduced in fear of incontinence.

Ultrasound probes with 5 and 10 MHz frequencies are used to detect venous reflux. A valve closure time >0.5 s was defined pathological. Although there are recent reports in the literature suggesting that the peak reflux velocity correlates better with the severity of venous insufficiency, valve closure time is more widely used.^17–19

Ambulatory venous pressure

AVP measurement is still considered the gold standard in the assessment of global reflux, function of the vein-muscle pump, and the severity of venous hypertension. A 21-gauge “butterfly” needle is inserted into a vein in the leg and connected to a pressure transducer, a pressure monitor, and a recorder. Cannulation of dorsal foot veins should be avoided due to the possibility of falsely normal values caused by functioning valves at the ankle level. A frame while standing supports the patients. At rest, the distance between the heart level and the cannulation site determines the recorded venous pressure. The patients then performed a standardized “walking on the spot” exercise. The mean venous pressure recorded when the curve flattens at the end of this exercise indicates the AVP. Normally the pressure drops to below 30 mmHg. The measurement is then repeated after selective occlusion of the superficial veins. A 30 cm wide pneumatic tourniquet is placed around the thigh and inflated to 60 mmHg to occlude the great saphenous and other superficial thigh veins. The small saphenous vein may be occluded with a rubber tourniquet. By selectively occluding the superficial segments it is possible to identify an insufficient venous system (i.e. either the great or short superficial saphenous veins or the deep system) (Figure 1).

Figure 1.

a: Vein pressure recording setup. b: Typical superficial vein pressure curves at rest and during walking in subjects with no venous insufficiency (normal), superficial- and deep venous insufficiency, and venous outflow obstruction. Note that dorsal foot vein is not cannulated. Pt: pressure transducer, PM: pressure monitor, AVP: ambulatory venous pressure. Reprinted with permission from Elsevier.²⁰

AVP measurement provides the following information: pressure drop during exercise, ambulatory pressure, and recovery time, which is the time taken from cessation of the step test until the resting pressure level is reached.²⁰

Transfemoral venography with descending video venography is a dynamic imaging method of the venous valve leaflets that may be amenable to repair allowing classification of the severity of axial reflux. It is performed through femoral puncture. By injecting contrast medium an obstruction in the ilio-caval segment can be excluded. The patient is then tilted 60°, head upward, and dye injected during a Valsalva maneuver. The dye column is followed until it stops or the Valsalva maneuver is completed (Figure 2) and graded into four categories according to Kistner: grade I proximally in the thigh, grade II above the knee, grade III below the knee, and grade IV to the ankle.²¹

Figure 2.

A sequence of six pictures from the descending video venography demonstrates venous reflux down to knee level (grade II). This exemplifies the advantage of video recording where the contrast medium can be followed dynamically at the desired speed to study venous valve function. Reprinted with permission from Elsevier.²⁰

MR Venography

MR venography using the balanced turbo field echo (b-TFE) protocol provides structural details and post-thrombotic changes in a detailed way.²²

Procedure

The internal venous valve plasty (IVVP) was introduced by Kistner in 1968. Some years later he also developed the external venous valve plasty (EVVP). Especially in patients with PCVI it is possible to find valves amenable to repair with one of these techniques. The feasibility of valve repair is determined by preoperative CDU and descending video venography.

Surgical technique

IVVP and EVVP

A conventional approach is applied in the groin through a longitudinal incision and a posterior approach in the popliteal fossa by using an S-shape incision. The routine use of magnifying loupes is highly recommended. The valve site and the commissural sites of the leaflets are identified by careful adventitial dissection.

IVVP requires a venotomy, either longitudinal or T-shaped. Special attention is needed to avoid injury to the leaflets. Single sutures of 7-0 polypropylene are placed to tighten the cusps laterally. The result of this plasty can only be tested until after the venotomy has been closed (Figure 3).

Figure 3.

Single sutures of 7-0 polypropylene are placed to tighten the cusps laterally in the internal plasty. Reprinted with permission from Elsevier.²⁰

EVVP avoids a venotomy but requires the clear visualization of the cusps and commissures through the vein wall. Angioscopy can be helpful in identifying the valve commissures and testing valve function. A continuous suture line of 5–7 stitches with polypropylene 7-0 is started at the cranial end of the valve to tighten the leaflets. This procedure is performed at the site of both commissures (Figure 4). The repaired valve, either by IVVP or EVVP, is then tested by the “strip-test” or angioscopy (Figure 5).

Figure 4.

The surgical technique of external venous valve plasty assisted by angioscopy: (a) a view of incompetent valve cusps and the first external suture placed in a commissure, (b) external sutures in both commissures (c) and the finished valve repair. Reprinted with permission from Elsevier.²⁰

Figure 5.

“Strip test” to confirm valve competency. Reprinted with permission from Elsevier.²⁰

Single plasties can be performed at the femoral or popliteal level. Multilevel plasties can be performed at both levels in the same extremity. The term multistation plasties refers to repairing more than one valve at the femoral level (common, superficial and deep femoral vein).

In SCVI the replacement of the venous valve is necessary.

Transposition

Seldom, a transposition can be performed and it involves taking a refluxive post-thrombotic vein segment and anastomosing it end-to-side, distally to a competent valve, for example the femoral vein anastomosed distally to a competent valve in the great saphenous or deep femoral vein 16 (Figure 6).

Figure 6.

Transposition involves taking a refluxive post-thrombotic vein segment and anastomosing it end-to-side, distally to a competent valve. Reprinted with permission from Elsevier.²⁷

Autotransplantation

A competent valve is identified preoperatively with CDU in the axillary or the saphenous veins. A vein diameter <5 mm and signs of fibrosis/trabecula diagnosed by CDU and/or venography are our criteria to determine those veins not fit for auto-transplant. A 6–8 cm long vein segment containing a functioning valve is harvested. Injecting saline solution tests the valve. The venous segment containing a competent valve is then implanted as an interposition by using in-lay suturing technique (Figure 7). This involves two end-to-end anastomoses with 6-0 polypropylene. We use a running suture, interlocking every other suture, to avoid a “purse-string” effect. The cranial anastomosis is performed first. The “strip test” confirms the competence of the transplant. The native vessel is “wrapped” around as reinforcement. Diameter discrepancy, thickening, and fibrosis of the native vessel pose the major technical challenges in this procedure.

Figure 7.

A venous segment from the axillaris or saphenous vein containing a competent valve is transplanted as an interposition by using in-lay technique. The native vessel is ‘‘wrapped’’ around as reinforcement. Diameter discrepancy, thickening and fibrosis of the native vessel pose the major technical challenges in this procedure. Reprinted with permission from Elsevier.²⁷

Neovalve

The post-thrombotic thickening of the vein wall can be utilized for the construction of a new venous valve. A 3–4 cm longitudinal venotomy is performed and excessive trabecule are removed. A transverse incision in the thickened intima and media layer is made extending to the lateral edges but keeping a bridge of ca. 2 mm in the middle portion. Careful dissection is advanced caudally avoiding adventitia perforation. The creation of two new cusps of ca. 1 cm in length is accomplished. A continuous 7-0 polypropylene suture fixates the new created cusps laterally. A watertight test is then performed. Venotomy closure is performed caudally given the opportunity to see the function of the new valve when releasing the cranial occlusive clamp.

Indications

RDVS has a clear indication in C5-6 patients. It is also suggested that C4 patients with high levels of AVP may benefit from RDVS before they advance to the development of an ulcer. However, it must be emphasized that failed conventional treatment is an absolute requirement before considering RDVS. The function of the leg muscle pump must also be intact. Physiotherapy should be employed to treat muscle atrophy caused by a long-standing active ulcer. Ankle arthrodesis represents a contraindication to RDVS.

Results and outcomes

It is important to report results in terms of clinical and hemodynamic outcomes.

The terms used are ulcer healing, ulcer recurring rates, and ulcer free period. CDU will assess competency of the reconstruction and AVP can quantify the hemodynamic improvement.

Durability is defined by the time a reconstruction remains competent assessed with CDU.

In the revision of 10 different materials including 655 patients, ulcer-healing rates of up to 70% were reported after RDVS. Generating ulcer free periods of a median 36 months (6–108) but freedom from ulceration fell to under 50% after five years. And clinical improvement of 80% was reduced during five-year follow-up to about 25%. The direct relationship between clinical improvement and competency of the reconstruction and its durability is also shown.^{12,20,23–30}

Technical aspects and outcomes

While some favor the internal valve plasty as more durable, it has the following disadvantages: it requires a venotomy with the risk of cusp damage and assessment cannot be done until the venotomy is closed. External trans-commissural valve plasty may be as effective as the internal technique but it requires adventitial dissection. No comparative studies have been performed to determine which technique is best.

The available donor sites for auto-transplantation are axillary veins and great- or small saphenous veins. Sometimes the axillary vein valve is found incompetent after it has been harvested and a bench plasty must be performed. It may seem logical to think that saphenous valves, when available and competent, can be a better choice, since the pressure they tolerate is greater than the axillary valves due to their anatomical location.

The neovalve construction is a technique that makes use of the structural changes caused by the inflammation in a DVT process. While it solves the problems of availability of adequate donors it represents a challenge to our technical skills. And the published materials encounter a problem to reproduce the original results. Our own unpublished results after one-year follow-up are inferior to those of Maleti.

Future perspective

The main concern now is durability of RDVS since the average age of patients that can benefit from it is about 50 years.

During the last two decades efforts have been made to develop stent-mounted bioprosthetic valves. The leaflets are made of synthetic or biological material (porcine small intestinal sub mucosa and pericardial tissue) mounted to a carrier or frame for percutaneous deployment. The difficulties encountered are early thrombosis, migration, autoimmune reaction, and incompetence.^31,32

Our group is at the moment working in the development of a device with percutaneous access.

It consists of a multichannel, IVUS guided device for the construction of a new valve by using hydro-dissection in the vein wall. The results in cadaver testing are encouraging so far.

Regenerative medicine may offer novel strategies for the creation of new valves.^33–35

We have shown in an in vitro study that by using perfusion decellularization/recellularization and human scaffolds it is possible to tissue engineer venous segments containing competent valves.

Tissue engineering might represent a more durable solution for this rather young group of patients. In addition, the required surgical skills will not be as demanding (interposition of a vein segment), which might help to spread this possibility of treating severe CVI cases.

Conclusion

The role and place of RDVS in the treatment of CVI have become clear but is not yet widely spread due to probably the need of advanced vascular laboratory to do the work-up, enough knowledge of the pathophysiology involved to be able to interpret the examinations and the necessary surgical skills. All of these are quite attainable if vascular units prioritize this field.

References

Nelzén

Bergqvist

Lindhagen

. The prevalence of chronic lower-limb ulceration has been underestimated: results of a validated population questionnaire. Br J Surg 1996; 83: 255–258.

Tennvall

Andersson

Bjellerup

. Treatment of venous leg ulcers can be better and cheaper. Annual costs calculation based on an inquirystudy. Lakartidningen 2004; 101: 1506e1523–1506e1523.

Simka

Majewski

. The social and economic burden of venous leg ulcers: focus on the role of micronized purified flavonoid fraction adjuvant therapy. Am J Clin Dermatol 2003; 4: 573–581.

Ruckley

. Socioeconomic impact of chronic venous insufficiency and leg ulcers. Angiology 1997; 48: 67–69.

Kahn

Shbaklo

Lamping

. Determinants of health-related quality of life during the 2 years following deep vein thrombosis. J Thromb Haemost 2008; 6: 1105–1112.

Kahn

Ducruet

Lamping

. Prospective evaluation of health-related quality of life in patients with deep venous thrombosis. Arch Intern Med 2005; 165: 1173–1178.

Kahn

M’lan

Lamping

. Relationship between clinical classification of chronic venous disease and patient-reported quality of life: results from an international cohort study. J Vasc Surg 2004; 39: 823–828.

Wright DDI. The ESCHAR trial: should it change practice? Perspect Vasc Surg Endovasc Ther 2009; 21: 69–72.

Kistner

. Surgical repair of the incompetent femoral vein valve. Arch Surg 1975; 110: 1336–1342.

10.

Kistner

. Deep venous valve reconstruction. Cardiovasc Surg 1995; 3: 129–140.

11.

Kistner

. Surgical repair of a venous valve. Straub Clin Proc 1968; 34: 41–43.

12.

Raju

Neglén

Doolittle

. Axillary vein transfer in trabeculated postthrombotic veins. J Vasc Surg 1999; 29: 1050–1062. discussion 1062–1064.

13.

Taheri

. Vein valve transplantation. Am J Surg 1985; 150: 201–202.

14.

Maleti

Lugli

. Neovalve construction in postthrombotic syndrome. J Vasc Surg 2006; 43: 794–799.

15.

Eklöf

Rutherford

Bergan

. Revision of the CEAP classification for chronic venous disorders: consensus statement. J Vasc Surg 2004; 40: 1248–1252.

16.

Rutherford

Padberg

Comerota

. Venous severity scoring: an adjunct to venous outcome assessment. J Vasc Surg 2000; 31: 1307–1312.

17.

Van Bemmelen

Bedford

Beach

. Quantitative segmental evaluation of venous valvular reflux with duplex ultrasound scanning. J Vasc Surg 1989; 10: 425–431.

18.

Neglén

Egger

Olivier

. Hemodynamic and clinical impact of ultrasound-derived venous reflux parameters. J Vasc Surg 2004; 40: 303–310.

19.

Labropoulos

Leon

. Duplex evaluation of venous insufficiency. Semin Vasc Surg 2005; 18: 5–9.

20.

Rosales

Slagsvold

Kroese

. External venous valve plasty (EVVP) in patients with primary chronic venous insufficiency (PCVI). Eur J Vasc Endovasc Surg 2006; 32: 570–576.

21.

Kistner

Ferris

Randhawa

. A method of performing descending venography. J Vasc Surg 1986; 4: 464–468.

22.

Enden

Storås

Negård

. Visualization of deep veins and detection of deep vein thrombosis (DVT) with balanced turbo field echo (b-TFE) and contrast-enhanced T1 fast field echo (CE-FFE) using a blood pool agent (BPA). J Magn Reson Imaging 2010; 31: 416–424.

23.

Lehtola

Oinonen

Sugano

. Deep venous reconstructions: long-term outcome in patients with primary or post-thrombotic deep venous incompetence. Eur J Vasc Endovasc Surg 2008; 35: 487–493.

24.

Masuda

Kistner

Ferris

. Long-term effects of superficial femoral vein ligation: thirteen-year follow-up. J Vasc Surg 1992; 16: 741–749.

25.

Perrin

Hiltbrand

Bayon

. Results of valvuloplasty in patients presenting deep venous insufficiency and recurring ulceration. Ann Vasc Surg 1999; 13: 524–532.

26.

Raju

Fredericks

Neglèn

. Durability of venous valve reconstruction techniques for “primary” and postthrombotic reflux. J Vasc Surg 1996; 23: 357–366. discussion 366–367.

27.

Rosales

Jørgensen

Slagsvold

. Venous valve reconstruction in patients with secondary chronic venous insufficiency. Eur J Vasc Endovasc Surg 2008; 36: 466–472.

28.

Tripathi

Sieunarine

Abbas

. Deep venous valve reconstruction for non-healing leg ulcers: techniques and results. ANZ J Surg 2004; 74(1–2): 34–39.

29.

Wang

S-M

Z-J

S-Q

. Effect of external valvuloplasty of the deep vein in the treatment of chronic venous insufficiency of the lower extremity. J Vasc Surg 2006; 44: 1296–1300.

30.

Sottiurai

. Technique in direct venous valvuloplasty. J Vasc Surg 1988; 8: 646–648.

31.

Pavcnik

Uchida

Kaufman

. Percutaneous management of chronic deep venous reflux: review of experimental work and early clinical experience with bioprosthetic valve. Vasc Med 2008; 13: 75–84.

32.

De Borst

Moll

. Percutaneous venous valve designs for treatment of deep venous insufficiency. J Endovasc Ther 2012; 19: 291–302.

33.

Olausson

Patil

Kuna

. Transplantation of an allogeneic vein bioengineered with autologous stem cells: a proof-of-concept study. Lancet 2012; 380: 230–237.

34.

Natasha

Tan

Gundogan

. Tissue engineering vascular grafts a fortiori: looking back and going forward. Expert Opin Biol Ther 2014; 15: 1–14.

35.

Badylak

. The extracellular matrix as a biologic scaffold material. Biomaterials 2007; 28: 3587–3593.