1. 52 PHLÉBOLOGIE
Some new considerations on venous
valvuloplasty: an international on line
debate
Giovanni B. AGUS
Professor and Director of Section of Vascular Surgery and Angiology, Department of Specialist Surgical Sciences,
University of Milan, Italy
Abstract tions. The description on monoscusp valvuloplasty by Opie
in Vasculab was accurate.
In 2008 a paper by John Opie, regarding the renewed role At the same time S. Camilli presented his technique of
of venous valvuloplasty and an intriguing discussion took external stretching valvuloplasty with a new device is « oval
place on VASCULAB, a well known network on line with shaped external support « (OSES), made by a Nitinol net-like
about 1300 expert members in phlebology guided by F. framework, very smooth, elastic and flexible, available in
Passariello as conceiver and coordinator. different size. The OSES device is suitable for the terminal
The valvuloplasty attempts to reduce blood reflux and and pre-terminal valves of the GSV and virtually for any
venous hypertension in chronic venous disease (CVD). The peripheral venous valve, on superficial and deep system,
technique requires a skilled and experienced surgeon and a also without ligation of the possible present competent col-
careful patient evaluation and selection. It could be a good laterals.
approach in selected cases with post thrombotic syndrome The discussion was ample and very interesting with the
(PTS). contributes of C. Recek, B.B. Lee, C. Franceschi, O. Maleti and
Some studies indicate in the nineties that valvuloplasty others, included J. Opie and S. Camilli.
or valvular replacement is an effective treatment for venous In general, R. Kistner considerations about Maleti’s tech-
incompetence in selective cases. After a concise valvulo- nique are true for all valvuloplasties: « I find no fault with
plasty story from Kistner to Maleti, despite the advances in valvuloplasty and I am anxious to see if others can duplicate
valvuloplasty, we point out that the surgical mainstay to the experience. Points that need to be expanded in these
correct CVD, deep and superficial or both, or primary vari- experiences are how many cases were evaluated and found
cose veins is great saphenous vein (GSV) ligation and strip- not to be candidates for this procedure, the length of the
ping but also various conservative or endovascular treat- learning curve for producing a reliably competent valve, and
ments. Nevertheless actually some clinical studies have whether there is any sign that these new valves will dege-
reported achieving long-term, effective competence of deep nerate with time. If this technique can be successful, the
venous system, as well as the superficial venous system, next question will be whether it can be achieved in a more
both after valvuloplasty or by implanting an external vein minimally invasive method »
support device.
J. Opie identified as an optional surgical solution for the Key-words: Valvuloplasty – Vein surgery – Chronic
large underserved patient group of PTS a new technique: venous disease
« monocusp surgery ». He presented a new surgical method
to replace a dysfunctional aplastic / dysplastic / absent
venous valve using the full thickness viable native vein wall Résumé
tissue (the monocusp) and covered the defect with an ultra-
thin synthetic e-PTFE vascular closure patch (iVenaTMe-PTFE En 2008, un article de John Opie sur le rôle remis au goût
patch) to successfully reverse venous insufficiency and its du jour de la valvuloplastie veineuse et l’intéressante dis-
effects both early and long-term with limited complica- cussion qu’il suscita, fut diffusé sur le site VASCULAB, un
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2. PHLÉBOLOGIE 53
réseau réunissant plus de 1300 experts internautes. F chaine question pourra concerner la mise au point d’une
Passariello en était l’initiateur et le coordinateur. méthode encore plus mini-invasive ».
Le but de la valvuloplastie est de diminuer le reflux san-
guin et l’hypertension veineuse dans les affections vei- Mots-clés : valvuloplastie, chirurgie veineuse,
neuses chroniques (AVC). La technique nécessite un chirur- affections veineuses chroniques.
gien expérimenté avec une sélection et une évaluation
rigoureuse des patients. Elle peut avoir tout son intérêt dans * * *
des cas bien sélectionnés de syndrome post-thrombotique
(SPT). A recent paper by John Opie, regarding the renewed role
Plusieurs études datant de la fin du siècle dernier ten- of venous valvuloplasty (1) and an intriguing discussion
dent à prouver que la valvuloplastie ou le remplacement took place on VASCULAB (2), a well known network on line
valvulaire est un traitement efficace de l’incontinence vei- with about 1300 expert members in phlebology guided by F.
neuse dans certains cas. En reprenant l’historique de la val- Passariello as conceiver and coordinator.
vuloplastie, de Kistner à Maleti, malgré les progrès réalisés,
on note que la conduite chirurgicale pour traiter les AVC, Venous Valvuloplasty story
profonde ou superficielle ou associant les deux, reste la
ligature / crossectomie des saphènes avec aussi quelques The valvuloplasty attempts to reduce blood reflux and
traitements variés conservateurs ou endovasculaires. venous hypertension in chronic venous disease (CVD). The
Néanmoins, aujourd’hui, des études cliniques ont démontré technique requires a skilled and experienced surgeon and a
une efficacité à long terme avec une continence correcte, careful patient evaluation and selection. It could be a good
aussi bien des veines superficielles que profondes après val- approach in selected cases with post thrombotic syndrome
vuloplastie ou implantation de manchons externes prothé- (PTS).
tiques. Some studies indicate in the nineties that valvuloplasty
J.Opie propose une option chirurgicale pour la large or valvular replacement is an effective treatment for venous
cohorte de patients présentant un SPT, et pour lesquels on incompetence in selective cases (3). The repair of incompe-
a peu de solutions à proposer actuellement ; cette tech- tent femoral vein valves in patients with primary valve
nique s’appelle la « chirurgie monocuspide ». Cette nouvelle incompetence was first developed by R. Kistner in 1968 (4).
méthode chirurgicale traite les valvules incompétentes, The original method involved a venotomy in the femoral
aplasiques, dysplasiques ou absentes en utilisant la paroi vein with the placement of sutures to shorten the vein
veineuse recouverte d’un patch en PTFE. Cela donne de bons cusps under direct vision, and others successful variations
résultats dans l’insuffisance veineuse, précocement ou à of open valve repair have been reported (5, 6, 7). The femo-
long terme avec peu de complications. ral vein valve repair was also carried out under direct vision
Parallèlement, S.Camilli a présenté sa technique de val- without venotomy with the use of angioscopy (8).
vuloplastie externe avec la prothèse OSES, élastique, Initially was a report by Garcia-Rinaldi from Houston,
flexible et disponible en plusieurs tailles. Elle convient par- more than 20 years ago with prosthetic bovine monocusp
faitement aux valvules terminales et pré-terminales de la patches in the superficial femoral and great saphenous
veine grande saphène et théoriquement à toutes les val- veins for CVD (9), and Sante Camilli from Rome in early
vules veineuses périphériques, des réseaux profonds et 1990 repeated the performance in a few cases, by applying
superficiels, sans ligature des collatérales compétentes qui a bovine pericardium monocusp (hand-made) into a super-
peuvent être présentes. ficial femoral vein (10).
La discussion a été très fournie et très intéressantes en Unfortunately, the « open vein » techniques (like Kistner,
particulier avec les contributions de C. Receck, BB.Lee, Raju, Sottiurai, etc) are difficult and challenging.
C.Franceschi et J.Opie et S.Camilli. Closed valvuloplasty was also developed by R. Kistner as
Les considérations de R.Kistner au sujet de la technique external venous repair. This technique involves complete
d’O. Maleti sont vraies pour toutes les valvuloplasties : « Je dissection of the femoral vein up to 4-10 cm in order to
ne trouve pas de faute dans la valvuloplastie et je suis impa- place sutures on both sides of the vein wall at the level of
tient de voir si d’autres peuvent répéter cette expérience. the valve commissures (11).
Les points à développer concernent le nombre de patients A technique for repair of incompetent venous valves
candidats à cette intervention et le nombre de récusés, la with an implantable device developed to restore venous
durée de l’apprentissage pour réussir cette technique, et s’il valve competence by reducing the vein circumference was
existe un signe quelconque témoignant d’une usure de ces proposed by D. Hallberg for deep veins in 1972 (12) and by
valvules au fil des années. Si les résultats sont bons, la pro- Hetènyi and Pahoky for superficial veins in 1985 as « the
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3. 54 PHLÉBOLOGIE
tunnel graft of greater saphenous vein » in Dacron (13) and the « final solution » but could reach a more satisfying out-
in other way experimented with success in two animal come than usual.
models with a silicone device named « venocuff » (14). Actually some clinical studies have reported achieving
Similar technique reinforce the commissure adaptation long-term, effective competence of deep venous system, as
based on the principle V. Krylov from Moscow introduced to well as the superficial venous system, both after valvulo-
B.B. Lee to perform a few case on the femoral vein after plasty or by implanting an external vein support device.
Kistner’s simple external valvuloplasty but wasn’t quite suc- For the deep incompetence recently we had a review
cessful with residual reflux. The intermediate results of all about valvuloplasty, indications and results by R. Kistner
three cases were dismal within a year as mentioned by B.B. (20) and we have a good analysis in french language by
Lee in Vasculab discussion (2). M. Perrin (21, 22) but from epidemiological point of
G. Belcaro in 1989 proposed an external valvuloplasty as wiew the CVD is enormously more frequent than the pri-
« plication » of the sapheno-femoral junction for primary mary venous insufficiency, and superficial reflux more
varicose veins (15), and after a plication of superficial femo- than deep reflux.
ral vein for deep incompetence (16). Finally, was developed About the indication and patients selection in CVD, the
a device comprised of expanded polytetrafluoroethylene suggested today are people suffering (a) GSV junctional
(ePTFE) with an embedded Nitinol alloy wire frame to pro- reflux with (b) movable and symmetric leaflets and (c) mild
vide a better basis for fixation. The device is wrapped to moderate PVV, but also (d) in secondary varicose veins. In
around the vein at the valve site to restore competency to secondary varicose veins, you may bring back the natural
an incompetent venous valve by remodeling the vein at the deterioration history by stopping the reflux and - at the
valve site, and/or by preventing local dilatation of the vein same time - you maintain the forward flow. Of course, it is
to which it is applied (17). suitable in primary deep venous insufficiency (PDVI) for (e)
Since more than 20 years in some series is performed a deep venous system external valvuloplasty as well.
competent-valve venous segment transplantation (18). From the technical point of view the main problems are
Another experience was presented in the 2000 with the to see both the commissures and a precise stitch applica-
Ven-Pro endo-prosthesis, following Quijano’s ideas, whose tion just at the apex of them. Should it be difficult to see
clinical trial was stopped because of unacceptable rate of the commissure apex, you may trans-illuminate the vein by
thrombotic complication. a small glassfibre inside.
The last landmark report of an exciting approach to defi- The rationale for sapheno-femoral external valvuloplasty
nitive treatment of late post thrombotic deep vein reflux is based on the histological finding that in the initial stages
(PTS) in highly selected patients was the case series of the valve cusps are still healthy but are incompetent because
endovascular neovalve construction by O. Maleti. Valvular of dilation of the vessel walls. It must be shown echographi-
cusps were created at the femoral site by dissecting the cally that the cusps are mobile and not atrophic in the ter-
thickened venous wall to obtain material with which to minal and/or subterminal part of the great saphenous vein.
fashion a new monocuspid or bicuspid valve (19). The aim is to bring the valve leaflets back together, closing
up the dilated vessel walls. This can be done by either sutu-
Venous superficial or deep valvuloplasty ring the wall directly or by « buckling » the vessel with some
sort of external prosthetic belt in silicone, Dacron, e-PTFE.
Despite the advances in valvuloplasty, the surgical Competence should be tested during the operation using the
mainstay to correct chronic venous insufficiency (CVI), deep milking maneuver or a Doppler scan, or both.
and superficial or both, or primary varicose veins (PVV) is After more than a decade in the experimental stage, this
great saphenous vein (GSV) ligation and stripping but also approach can now boast encouraging results from multi-
various conservative o endovascular treatments. center randomized clinical trials, as long as the surgical
For the superficial insufficiency many phlebologist today indications are respected and external valvuloplasty is fea-
have been convinced, by their own practice and literature, sible (23, 24, 25, 26, 27), and the Italian College of
that conservative strategy, when applicable, has a better Phlebology Recommendations are: external valvuloplasty of
outcome than ablative one in varicose veins treatment. At the terminal and/or subterminal valve of the great saphe-
the same time, even if the first reason of recurrent varicose nous vein, after thorough preoperative assessment, and
veins may be a genetic-hormonal one, but the second cer- with careful intraoperative checks, is a good way to treat
tainly is hemodynamic - to be precise, the GSV ablation saphenous reflux in 5-8% of patients. Grade B (28).
itself. At the present conservative approaches (e.g. CHIVA Really, both the Gore-EVS (now out of the market in
technique, collateral selective ligation, endovascular treat- Europe for economics reasons) and the Venocuff are unfit-
ments) with a reliable valvuloplasty technique may be not ting in several cases, and - anyway - they are of unpredic-
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4. PHLÉBOLOGIE 55
table result because they bundle up valve leaflets on a blind by the patient around 3 years. As a result, for this reason
way. Moreover, these devices need collateral ligation which J. Opie identified as an optional surgical solution for this
involves the collateral stump deforming the valve wall’s large underserved patient group a new technique: « mono-
shape. New devices may be applied around the junctional cusp surgery ». He presented a new surgical method to
valves (terminal and pre-terminal) without collaterals invol- replace a dysfunctional aplastic/dysplastic/absent venous
vement. valve using the full thickness viable native vein wall tissue
(the monocusp) and covered the defect with an ultrathin
The Opie’s and Camilli’s proposals synthetic e-PTFE vascular closure patch to successfully
reverse venous insufficiency and its effects both early and
Deep venous thrombosis (DVT) induced CVI, and about long-term with limited complications. He moved around
5% of the population have this ghastly, aggressive illness. that by formally redefining the operation, using these
Previous reparative valvular surgical options directed at terms to book surgery: (a) CFV valvuloplasty (monocusp);
reconstructing damaged common femoral vein (CFV) (b) CFV patch venoplasty.
valves associated with pathological CVD have not succee- Make sure the diagnosis is correct have a duplex in the
ded in reliably managing CVD. In consequence, venous ORs if you want and have anesthesia Valsalva before and
valvuloplasty is rare and most patients are managed after implant. It’s quite interesting duplex with a sterile
conservatively. sheath right on the CFV. You have to get the duplex head
Maleti’s techinque gives today great credit but the same below the monocusp (Fig. 1).
author points out the intrinsic limits for clinical indications The description on monoscusp valvuloplasty by Opie in
in absence of valve flaps and PTS, and technical feasibility. Vasculab was accurate.
Probably for these reasons we have now interest for the two Clean off the adventitia, liberally coat the CFV early and
new proposals by Opie for frequent PTS patients and by frequently with papaverine as it wants to spasm. Don’t let
Camilli for more frequent CVD patients. that occur.
J. Opie published (1) and discussed in Vasculab (2) that Draw the lines on the CFV before you place any clamps.
current external compression treatments are largely a Make the cuts as potbellied as convenient. Each cut is about
giant expensive failure. The secret here is to continuously as long as the vein’s diameter - has to reach the back and
control (normalize) internal distal venous hypertension - if side walls. Don’t over do that however, minor monocusp
you do that successfully, external compression is not leaks are well tolerated.
necessary anymore and normal venous physiology is res- Make sure the patient is fully heparinized before clam-
tored. Over time the results are startling. Symptoms ping.
resolve, ulcers heal, swelling resolves, compression hose The external aspect of the CFV between the distal and
are support devices of the past (Opie’s point of view). proximal clamps was examined for any indication of valvu-
Hemosiderin starts to resolve commencing around 2 years lar sinuses and to avoid injuring a valve that might be repai-
and liposclerosis also resolves, and is particularly noticed rable.
Fig. 1 - Monocusp technique: a representative
echo, before the monocusp. Grade 4 CFV reflux
by Valsalva (with permission J. Opie)
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5. 56 PHLÉBOLOGIE
Fig. 2 – In a view of stylized CFV illustration of
the monocusp operation and proper valve func-
tion.
(A) View of the monocusp looking down at the incisions and
sutures. (B and C) Transverse view of the monocusp while
open and closed, respectively. (D) View of the completed
operation with the iVenaTM e-PTFE vascular patch covering
the monocusp. (E and F) Lateral views of the monocusp
while open and closed, respectively. Arrows denote the
direction of venous blood flow (with permission J. Opie).
Three necessary incisions were made to construct the
monocusp valve (Fig. 2), on the anterior surface of the
clamped CFV in the manner of a trap door with an uncut
distal hinge.
Each incision should have a 1–2 mm convex outward
track so as to conform to the rounded, filled vein when the
vein re-expands to its circular, tubular shape after the ope-
ration was completed.
If no repairable valve was identified at the site of the
incision, the monocusp operation should be continued. All
incisions were as long as the diameter of the vein.
Make the leading edge sutures long enough so that the
monocusp can function - both open and close, but do not
let those leading edge sutures get too long - that will allow
the leading edge of the monocusp to approximate the e- Fig. 3 - Appearance of the iVena TM e-PTFE vascular patch
PTFE patch (iVena TM). If that occurs, the monocusp and the after suturing into the correct position (with permission
patch will tend to adhere and the operation will fail. That J. Opie).
has happened once to us and we had to redo above. Think
of these leading edge sutures as similar to the chords Put the patient on coumadin for 6 months, then convert
restraining the mitral valve. to ASA for life. Major venous surgery has much more poten-
The Lateral Edges (LE) suture length is the most impor- tial of DVT in comparison to arterial surgery.
tant and it is also the most frustrating. Once they are both
placed, check the monocusp excursion and replace if too The role of Camilli’s technique
excessive or insufficient. That is part of the art involved.
Some lateral leaking is not rare, but usually it has no clini- Recently S. Camilli from Rome has reported a new tech-
cal effect. nique: the external stretching valvuloplasty. The preliminary
One way of assessing the LE suture length is to place the trials, both experimental and clinical, gave positive out-
two corner sutures fold the moncusp to closed, have your comes in terms of safety and efficacy, and was presented to
assistant hold it there and tie the back wall sutures usually the Italian Society of Vascular and Endovascular Surgery
around 7 and 5 o’clock at the level of the proximal cut (29). This is an innovative working principle which aims to
against the resistence. But remember the vein wall with give a stretching action on the opposite inter-commissural
stretch and these sutures can become too short. Don’t tie walls, and parallel to the free edge of the valve cusps, to
these sutures with too much pull that will drag the vein into modify the cross section of the valve so that the cusp’s free
a closed position must avoid that. edge extralength is reabsorbed. A new device has been
This operation works well when done right. developed, working as a surgical implant around the incom-
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6. PHLÉBOLOGIE 57
Fig. 4 - Here is the same patient 1 hour later.
I.E. monocusp now in place (with permission J.
Opie).
Fig. 5 - The stretching action of
OSESTM (with permission S.
Camilli): vein wall axial view;
Oval Shaped External Support;
slackened valve cusps; cusp’s
coaptation and function recovery;
OSESTM stitched.
petent venous valve which increases the inter-commissural Discussion
diameter and, inthis way, resulting in the valve cusp’s coap-
tation and function recovery (Fig 5). The new device is an First, C. Recek put some questions and a comment
Oval Shaped External Support (OSESTM), made by a Nitinol addressed to colleagues who perform valvuloplasty: the
net-like framework, very smooth, elastic and flexible, avai- necessity to perform selective valvuloplasty with additional
lable in different size (3 sizes just now) (Fig. 6). The OSESTM procedure and the necessity to verify the results plethys-
device is suitable for the terminal and pre-terminal valves mographically to achieve normalization of the venous
of the GSV, also without ligation of the possible present hemodynamics. As concerns the indication to valvuloplasty,
competent collaterals. Virtually the Camilli’s device can be it must be distinguished between PVV and PTS. In PVV could
useful for any peripheral venous valve, on superficial and be taken into consideration for valvuloplasty the incompe-
deep system, obviously when the valves are present. tent CFV and the incompetent GSV. As concerns the femo-
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7. 58 PHLÉBOLOGIE
management is treatment of the superficial varicose veins
by ELT, RF, stripping, phlebectomy, foam etc whatever is the
preferred method of the surgeon. Monocusp is certainly not
indicated with such conditions. However, if PVV and CVI
exist at the same time in the same patient, he chose to cor-
rect the superficial varicose vein conditions first, and see
how the patient does. If the CVI is still an issue then he
recommends a valvuloplasty - if usable valves are encoun-
tered then can do a Kistner type repair (this is quite uncom-
mon in secondary CVI). If no valves or no usable valves are
encountered then Opie proceed with a monocusp.
Regarding the last point, B.B. Lee disagreed with Recek’s
quotation of absence of valves in the femoral vein, and in
the same way Opie, quoting a Canadian pathologist study in
«nonvenous» patients that founded the absence of valves in
CFV in only 21% (34), replied that a competent valve(s)
lower down the leg in the femoral vein may well control CVI
even if the CFV valves are leaking. All it takes is one deep
valve to remain competent and CVI will not occur. As
concerns the absence of competent valves in deep
veins above the SFJ in PVV, Recek opposed that
« Trendelenburg is correct, pathologist Basmajian not »,
confirming unequivocally Trendelenbug´s findings by
venous pressure measurements and registration of pressure
Fig. 6 - Oval Shaped External Support by S. Camilli (with waves (35). A pathologist can recognize the valves, but he
permission S. Camilli). is not able to credibly assess whether the valve is compe-
tent or not. This is possible and convincing in the standing
position in a live person.
ral vein, from the hemodynamic point of view it does not Considering that we need to make an effort, aiming to a
matter whether the femoral vein is competent or not: the more conservative and even reconstructive approach to vein
ambulatory pressure in this vein is in both cases the same, surgery S. Camilli exposed the opinion the time is mature,
reminding the work of Höjensgard and Stürup that the the technique also, the technology a bit less for valvulo-
hydrostatic pressure in the femoral and popliteal veins plasty, opposing Recek’s some statements.
remains uninfluenced during the activity of the calf muscle The on line discussion was also stimulate by an agree-
venous pump (30). On the other hand, when GSV reflux is ment on the term venous hypertension remembering that
accompanied with CFV incompetence, abolition of saphe- there are two kinds of venous hypertension: the hydrostatic
nous reflux alone, without influencing the femoral incom- one and the ambulatory one. But Opie added a third kind of
petence, restores the disturbed venous hemodynamics to «malignant» venous hypertension, the « constant » venous
normal (31, 32). Analogously, cases with incompetence of hypertension (WBCs and RBCs accumulate via the super
the small saphenous vein (SSV) are very often accompanied high constant venous pressure expanded desmosomes and
with incompetence of the popliteal and femoral vein and the end result is first hemosiderin staining followed by
abolition of the SSV reflux alone restores the disturbed liposclerosis followed by skin break down and venous ulcers
venous hemodynamics to normal (33). Finally, Recek development potentialy eliminable repairing a valve in the
emphasized that deep vein incompetence of the iliac, femo- CFV).
ral and popliteal veins per se do not cause CVI provided the C. Franceschi presented his practical heamodynamics: (a)
valves in the lower leg veins are competent, the outflow mechanical venous valve competence is not a problem
pathway is patent and no shunting of blood in superficial because it can be achieved according to various techniques;
venous system is present. (b) mechanical venous valve challenge is to be not des-
Regarding the Recek’s standpoint valvuloplasty of any troyed by DVT; (c) mechanical venous competent valve effi-
kind indicated or not with varicose veins treatment, Opie ciency cannot be different from a natural one in terms of
replied that if the PVV are due to GSV or SSV and/or acces- haemodynamic outcomes; (c) mechanical venous compe-
sory vessel incompetence and no CVI exists, the correct tent valve has to be located at an haemodynamic strategic
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8. PHLÉBOLOGIE 59
point which requires an appropriate and tailored strategy. full capacity to 100% endothelialize its external surface due
Hydrostatic pressure fractioning is obviously more efficient to the different receptors triggered by now becoming intra-
to lessen the ankle pressure when the valve is located at the vascular rather than being programmed by the extravascu-
popliteal vein than at the CFV. Anyway, the dynamic frac- lar tissue milieu. He figures that will have occurred by 5-6
tioning at the CFV is efficient proportionally to its height; months. For those reasons he gives coumadin for 6 months
(d) accurate hemodynamic assessment permits to apply and then switch it out to daily ASA 81 mg for life. By then
deep CHIVA strategy with good long term outcomes but the external surface of the monocusp is likely fully endo-
only when closed shunts are usable for disconnexion (36, thelized and actively secreting NOS and TM, and the inner
37). surface of the iVena e-PTFE patch will also be covered by
O. Maleti remembered that the inward flexing of a some form of deposited intimal tissue with +/- hormone
venous segment in order to create a flap working as a valve capacity. All it would likely require is an antiplatelet drug
was first suggested by Karagoz in 1993 (38); the segment (ASA). Doing this he has not encountered any late DVTs now
used by Karagoz was the terminal end of the GSV. Opie out to 5.5 years with zero support device management and
creates a flap fixed only in one extremity and free in both all patients are living an unrestricted lifestyle.
lateral edge fixed by two stiches. Maleti thinks that such a B.B. Lee asked for critical fact claimed by Opie: «the
flap presents some serious fixing problems. It is in fact well external surface once exposed to blood will acquire an
known that the valve is subject to an important pressure, endothelium and produce the antithrombotic hormones
and the best results are obtained when a very large flap is within 4 months », asking also for references in this regard.
used, being able to create a « sailing effect ». The same hap- If so, it is revolutionary! What mechanism controls these
pens in nature: valves are not simple diaphragms anchored developments? The Opie’s reply was: « I suspect it is hormo-
in a single point, otherwise the side pressure would cause nal-receptor based and whatever microenvironments act on
the vein to expand, and a blood leakage caused by poor those blood vessel wall progenitor cells. In the blood it pro-
fixing would inevitably occur. Valves are true pockets which grams the living vein wall to grow endothelium. I suspect
inflate following to the expansion occurring at the sinus that if you place the adventitial side of a living blood vessel
venous level, and it is just such mechanism that ensures the inside the blood stream over time it will react to the new
continence effect, as F. Lurie has widely explained in his hormonal environment and it will become lined with endo-
hemodynamics researches. Opie’s technique would greatly thelium because it is alive ».
benefit from increasing the diameter of the flap inserted to According to R. Kistner and M. Perrin, the major risk after
the extent of two thirds of its circumference, fixing it on the neovalve and any other deep venous reconstruction proce-
edges and increasing the length of the flap itself. In such a dure is not related to postoperative thrombosis as far as the
case, the patch will cover the circumference by 2/3. Opie patient is postoperatively fully anticoagulated but recur-
agree with Maleti’s thoughts here. The monocusp is by no rence or persistence of deep reflux in the other deep venous
means as clever nor as good as a native valve with sinuses system mainly the profunda femoral vein or secondary valve
etc, but it is a viable structure and if the iVena patch is used, reconstruction degradation.
it (the patch) bulges anteriorly when the clamps are remo- Regarding these Opie suggests a name change from CVI
ved and an anterior sinus is created. How long that bulge - which infers the condition is incurable and chronic to DVI
remains Opie doesn’t know. It is easy to make the flap long (Deep) meaning that now with additional input from scien-
simply by extending the vertical incisions - not so easy to tific minds, we actually have a good chance at beating this
make it widewide the diameter of the vein limits. ancient curse with what appears to be a low-risk long-term
Opie stressed the tendency to form a DVT will be present effective, easy to complete operation (DVI is similar to DVT).
to some extent in all venous reconstructive surgeries and
that tendency will be likely a constant situation if non- Conclusion
viable tissue (such as an intimal dissected flap) or a pros-
thesis is placed into the venous circuit. Constant anticoa- Fausto Passariello, Vasculab Moderator, concluded that
gulation is probably required here. The reason why Opie we understand that actually 3 valvuloplasty methods must
choses a full thickness vein wall structure is that with one be compared, the ones by Opie, Maleti and Camilli, already
side being uncut that means the flap is vital. That infers tested in living humans. Franceschi method was tested only
several hypothetical very beneficial activities: (a) the mono- in vitro and is mechanically highly efficient (39).
cusp will secrete nitric oxide synthase (NOS); (b) the mono- Other methods, which are worth citing for historical rea-
cusp will secrete thymomodulin (TM); both powerful local sons, have however a high rate of failure. At the end of this
vessel wall anti-thrombotic micro hormones/enzymes; discussion, a very interesting topic was started, about the
(c) because of its vitality, the monocusp will likely have the functional value of venous valves in the deep venous sys-
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9. 60 PHLÉBOLOGIE
tem, and superficial too. However, cited papers are often 14. Jessup G, Lane RJ Repair of incompetent venous
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papers. Indeed, Doppler Ultrasound investigations added a 15. Belcaro G Plication of the sapheno-femoral junction.
lot of observations in the living patient deep system, which An alternative to ligation and stripping ? VASA 1989; 18:
claim for a new physiopathological interpretation. 296-300.
R. Kistner considerations about Maleti’s technique are 16. Belcaro G, Ricci A, Laurora G, Cesarone MR, De
true for all valvuloplasties: « I find no fault with valvulo- Sanctis MT, Incandela L Superficial femoral vein valve repair
plasty and I am anxious to see if others can duplicate the with limited anterior plication. Phlebology 1994; 9: 146-9.
experience. Points that need to be expanded in these expe- 17. Incandela L, Belcaro G, Nicolaides AN, Agus GB,
riences are how many cases were evaluated and found not Errichi BM et al Superficial vein valve repair with a new
to be candidates for this procedure, the length of the lear- external valve support (EVS). The IMES (International
ning curve for producing a reliably competent valve, and Multicenter EVS Study). Angiology 2000; 51: S39-52.
whether there is any sign that these new valves will dege- 18. Taheri SA, Elias AM, Yacobucci CN et al Indication
nerate with time. If this technique can be successful, the and results of vein valve transplant. J Cardiovasc Surg 1986;
next question will be whether it can be achieved in a more 27: 163-8.
minimally invasive method » (40). 19. Maleti O, Lugli M Neovalve construction in post-
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