NeoValve for Post Thrombotic Syndrome

Professor Braithwaite runs a specialist clinic for people who have had deep vein thrombosis and now suffer from post-thrombotic syndrome (PTS)

One type of PTS is called reflux PTS.

An operation was designed in the 1990s for the treatment of reflux PTS and Professor Braithwaite has performed it on over 30 patients.

Information, including the preliminary results as well as an individual patient’s feedback can be found below.
If you are interested to know more about the procedure, please book and appointment or make contact by email to enquires@veincare.net

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Deep Vein Neovalve results for post thrombotic syndrome

Post Thrombotic Syndrome

To understand what happens after a deep vein thrombosis it is necessary to understand how blood flows in the veins of the legs.

The Normal leg and valves

In a normal leg, blood flows from the foot, back to the heart, through tubes called veins. When you stand up, the blood is prevented from falling back to the ankle by a series of one way valves in the deep veins and superficial veins.

The Calf muscle pump

In the calf muscle in each leg, there are many veins. As the muscle contracts, when you walk, run, or move the foot, the muscle squeezes the veins and pumps the blood in the vein back towards the heart. This is called the calf muscle pump. It is a bit like a heart for the veins.

What happens when a clot forms in the deep vein?

This is called a deep vein thrombosis or DVT. Reduced flow in the vein, damage to the wall of the vein or a thickening of the blood can cause blood to clot in the vein. When this happens, no blood can flow through the vein. This means the leg can become hot and swollen as the venous blood has to can only get back to the heart through small channels.

How a thrombus blocks a vein and damages a valve.

An analogy would be a dam being built across a river bed. The fields that drain into the river would become flooded or water-logged ( the swelling of the leg). The fields can only drain through other streams away from the river.

In time, and this varies, the small channels gradually enlarge to carry more of the blood. This is why some people who have had a DVT can develop prominent veins. Some people think these might be varicose veins. If the valves in these veins are working normally, then removing them can make the leg worse. This is why anyone who is going to have varicose vein surgery after a DVT should have a Duplex scan.

As the small channels enlarge, the leg swelling can reduce.

At the same time, several things can happen to the veins that were affected by the DVT. The human body is good at clearing thrombus by a process called thrombolysis.

If all the thrombus is cleared then the deep veins may be undamaged. In many people who have had a DVT, the thrombus leaves scars within the vein. This scarring can damage the valves and narrow the diameter of the veins.

What problems does scarring of the veins cause?

Aching legs and swollen legs.

If the valves in the deep veins are damaged then blood runs in the wrong direction, towards the ankle. This puts extra pressure on the ankle’s blood vessels which means the leg can swell. Many people with this problem of incompetent deep veins ( valves that do not work) have pain in their leg when they stand up. The pain can get worse as the day continues. They only get relief when the lie down again.

Some people have a feeling of a rush of blood into the calf when the deep veins are incompetent.

Failure of the calf pump.

The scarring of the veins can narrow their diameter. This means the calf muscle can only pump small amounts of blood out of the leg. This makes it difficult to drain the blood from the leg.

When the incompetent valves and failed calf pump are combined, the leg can become increasingly swollen and painful. This condition is the Post-Thrombotic or Post-Phlebitic Syndrome.

What can happen if I develop the Post-Thrombotic Syndrome?

Apart from the aching and swelling of the leg, there can be changes in the colour of the skin of the leg. Ultimately, the skin of the leg can become so damaged that an ulcer develops.

The leg can change in appearance to look a little like and upside down champagne bottle.

Can anything be done to help?

The most important thing to do is to prevent the deep vein thrombosis in the first place. For more information on DVT prevention, click here.

When a DVT has occurred, it may be possible to remove the thrombus by dissolving it or removing it surgically. Most doctors will, however, suggest that the DVT is treated by anticoagulation ( thinning of the blood) with an injection called heparin or a tablet called warfarin.

If you have the post-thombotic syndrome, you will have been advised to wear some form of compression stocking. These can help the swelling and pain.

Some patients cannot or do not want to wear stockings. For these patients it may be possible to correct the deep vein problems with an operation.

Mr Braithwaite has been trained in deep venous surgery. He has written about his training in the United States.

Can I have Deep vein surgery?

Mr Braithwaite has a research programme designed to test the best ways to treat the post-thrombotic syndrome. He uses a new method to rebuild a valve in the deep veins. Not everyone is suitable for deep vein surgery. If you want to discuss the possibility of deep vein surgery, please contact Mr Braithwaite.

venous%20system

The Venous System and how Valves Work

thrombus in vein

How a Thrombus blocks a vein
and damages a valve.

post thrombotic vein diagram

The Changes in a Vein that cause the Post Thrombotic Syndrome

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Patient Story from Wendy who had the Neovalve procedure

Text taken from the Daily Mail

 

ME & MY OPERATION: New procedure to give you perfect pins after a painful blood clot

  • 60,000 people a year develop a deep vein thrombosis – a blood clot in the leg
  • Many survivors are left with long-term painful swelling, which feels unsightly 
  • Wendy Yaxley, 53, from Lincoln, who works in admin at an antiques fair, was one
  • She’s one of the first-ever people in the UK to have a pioneering new treatment 

By PAT HAGAN in the Daily Mail – link to original’s article

PUBLISHED:

THE PATIENT:Wendy Yaxley, 53

During my late teens I developed a throbbing pain in my left hip that spread down my leg.

One Saturday night I called the out-of-hours GP, who diagnosed a trapped nerve in my back and advised paracetamol and rest. But the next day I was crying in pain and the whole of my left leg was blue and swollen.

I rang the GP again and this time he said it was likely to be a deep vein thrombosis (DVT) — a blood clot in a deep vein in my left leg — and that there was a risk it would dislodge and travel to my heart or brain, triggering a heart attack or stroke. I was terrified.

He did not explain what could have caused it — I suspect it was linked to me taking the contraceptive Pill after the birth of my first child.

The GP prescribed warfarin to thin my blood and dissolve the clot. After a week spent mainly in bed, I managed to stand up, but my left leg was still swollen and throbbing with pain.

I continued to take warfarin for six months and gradually the swelling went down, though it did not disappear.

That’s how my health stayed for the next 30-odd years, during which time I suffered daily pain. Doctors told me that although the DVT clot had disappeared, I now had post-thrombotic syndrome, where inflammation caused by the clot had damaged valves in a vein in my leg.

Normally, valves open and shut to keep blood flowing in the right direction, but because of the damage, valves in my leg were stuck in the open position. As a result, blood pooled in the lower part of my leg.

It caused unsightly discolouration (a distinctive purple-blue colour), swelling at times and pain when I walked.

I could feel my leg filling with blood when I stood up — it felt like bubbles.

I struggled to keep jobs as I couldn’t stay on my feet for more than a few minutes and life was difficult with four children. I had to spread the shopping, ironing and cleaning over several days.

I begged many GPs for help but was only offered compression stockings to improve blood flow. They provided slight relief, but as soon as I took them off the problem returned. 

In 2015, I went to my GP again and was referred to a haematologist. During the examination, they mentioned a new type of surgery that was being trialled.

Results of Surgery

A few weeks later I met Bruce Braithwaite, the vascular surgeon pioneering the technique. He explained that the operation involved creating a new valve using a small bit of vein from a healthy one in my thigh. The new valve would work just like a normal one.

 I was able to buy my first ever pair of knee-length boots, ride on my husband’s motorbike without it aggravating the pain, and wear jeans.
Wendy Yaxley 

I had the procedure under a general anaesthetic and went home the next day. The improvement was dramatic. Within days my left leg was the same size as my right.

It’s changed my life — the pain and swelling have gone. I was able to buy my first ever pair of knee-length boots, ride on my husband Peter’s motorbike without it aggravating the pain, and wear jeans. Since the surgery three years ago I’ve been able to start work part-time.

Best of all, I’m able to run around with my seven grandchildren, pain-free and mobile like I was in my teens.

THE SURGEON

BRUCE BRAITHWAITE is a consultant vascular surgeon at Nottingham University Hospitals NHS Trust.

Prolonged inactivity, obesity and taking the Pill are some of the risk factors for a DVT.

We treat it with blood-thinning drugs, such as warfarin, which dissolve the clot — this stops it blocking any more of the vein or moving to other blood vessels, where it can cause stroke, heart attack or potentially fatal pulmonary embolism (where the clot blocks the pulmonary artery that carries blood from the heart to the lungs).

Some patients must take these drugs for life whereas others only until symptoms resolve.

Around 60 per cent of people with DVT will develop post-thrombotic syndrome.

As a result they are left with a painful, swollen leg because blood that should be pumped back through the veins to the heart, instead pools in the legs as soon as the patient is upright — a problem called reflux.

Patients are also at risk of ulcers due to extreme pressure from all the blood that collects inside the veins damaging tiny blood vessels in the skin.

Many patients are at risk of another DVT as blood continues to pool, so are prescribed warfarin for life.

The other standard treatment is to wear compression stockings, but some patients find them hot and uncomfortable.

Various surgeries have been tried, including procedures to repair the damaged valves and, recently, insertion of tiny metal tubes — called stents — to prop open veins that have collapsed or narrowed because of the scarring effects of the DVT.

However these don’t really work for all DVTs as stents cannot repair or replace the faulty valve.

This new procedure was developed in France but, as far as I am aware, I am the only surgeon in the UK performing it and leading trials.

The idea is to create a new valve, made from a tiny piece of healthy vein, to reduce the flow of blood back down the leg.

First, we make a 6in incision in the groin to harvest a 1.5in section of the great saphenous vein, which runs the length of the leg. This piece of vein is turned inside out until one end overlaps the other to form a cup-shaped piece of tissue.

It is taken through the same incision then stitched inside the common femoral vein, a large vein which is the major route for blood travelling back up to the heart.

The new valve is stitched in such a way that it works in a similar fashion to a normal valve — opening in one direction to let blood through, but blocking its passage in the other direction.

The whole procedure takes less than an hour and because we are using the patient’s own tissue, there are no problems with rejection.

I have performed the procedure on around 30 patients and have submitted data on the results for publication.

These results show 70 to 80 per cent reported significant improvements in terms of reduced pain and swelling, while 80 per cent of ulcers healed completely in weeks.

■ Surgery costs £3,000 to £5,000.

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Scientific Paper on the results of the Neovalve Procedure, submitted for peer review and publication but not yet published.

Verification of the results of Plagnol’s Neo-valve for the treatment of Post-Thrombotic Syndrome with reflux

Richard J. Simpsona,b  

Linda Kimania

Laura Caronea

Richard O’Neillc

Bruce D. Braithwaitea,*

aDepartment of Vascular Surgery, Nottingham University Hospitals NHS Trust, Nottingham, UK

bRadiological Sciences, Division of Clinical Neuroscience, School of Medicine, University of Nottingham, UK

cDepartment of Radiology, Nottingham University Hospitals NHS Trust, Nottingham, UK

What does this study add?

This study reproduces the previous work by Plagnol with similar, longer term results.  Creation of a neo-valve by invagination of the GSV can help relieve the symptoms of  PTS, including healing chronic venous leg ulcers.  Further work is needed to compare the procedure with best medical management using compression therapy and to understand how the valve works.

Abstract

Objectives

Neo-valve surgery for Reflux Post-Thrombotic Syndrome (PTS) is uncommon despite being described over 20 years ago. This study aimed to repeat the methodology described by Plagnol to see if similar and more long-term results could be obtained in a cohort of eighteen patients with moderate to severe reflux PTS. 

 

Methods

Twenty legs in 18 patients (12 male), mean age 46 years (range 24-75), had attempted neo-valve surgery.  The median clinical category (C) of the CEAP classification was 5 (range 3 to 6).  All patients had clinical and radiologically confirmed reflux PTS, with a median duration of 9.75 years (range 2-32 years).   10 legs had active ulceration. 

A neo-valve was created by inverting the Great Saphenous Vein (GSV) into the Common Femoral vein.  Patients were asked to continue with the same compression therapy they were using before the procedure. Change in PTS severity was determined by Villalta Score, Venous Clinical Severity Score (VCSS) and Bathel index.

Results

The median time to follow-up was 3.5 years (range 3 months to 11 years).  Eight of the ten ulcers had healed at follow up. Fifteen of the 18 patients (83%) reported an improvement in symptoms following surgery.  Of those patients without improvement, one developed a deep vein thrombosis, one had no change in symptoms and a third patient suffered from chronic femoral neuralgia.  The median Villalta score improved from 15.5 (IQR= 14 to 22) to 8 (IQR= 5 to 15) (P=.001).  There was also an improvement in the VCSS score from a median of 17, (r 11 to 21) to 8.5, (r 5.75 to 15.25). 

Conclusions

The results confirm Plagnol’s original work. Neo-valve surgery using inversion of the GSV appears to help the majority of suitable patients with reflux post thrombotic syndrome. 

Keywords: Post-Thrombotic Syndrome, venous insufficiency, venous thrombosis, Villalta score, neo-valve.

 

Introduction

Post Thrombotic syndrome (PTS) affects some 50% of patients who have a deep vein thrombosis (DVT)1.  The incidence is greater in those with an iliofemoral DVT.2  PTS is caused by chronic venous hypertension via two principal mechanisms; venous outflow obstruction (obstructive PTS) and secondary valvular incompetence causing venous reflux (reflux PTS) or a combination of the two.3  Signs and symptoms include chronic limb pain; lipodermatosclerosis; venous eczema; varicose veins; leg swelling; ulceration, which can lead to severely decreased quality of life and physical disability.4  Patients with PTS frequently have to modify their daily activities and employment as a result of the severity of symptoms. They are frequently told that there is nothing that can be done to help their symptoms.  Many of these patients are managed by haematologists or primary care physicians and rarely see a vascular surgeon.

Whilst iliac vein stenting and similar interventional procedures are exciting developments in the management of outflow obstruction, there has been little progress in the management of deep venous reflux.  The normal management of reflux PTS is compression therapy with the attendant issues of compliance.  Operations have been described to repair incompetent valves and to create valve leaflets from the scar tissue within the deep vein.5  Plagnol  developed a simple technique of invagination of the great saphenous vein (GSV) into the common femoral vein (CFV) of a leg affected by deep venous reflux6.  This technique creates a neo-valve with the aim of reducing venous reflux and hypertension.  This article presents the medium-term results of the neo-valve in a cohort of patients with PTS, after the senior author was trained in the procedure by one of Plagnol’s original team.

 

Methods

Patients

Patients seen by the senior author were identified as possible candidates for the procedure because they ( the patients) felt that they had symptoms of PTS that were severe enough for them to want to be considered for a procedure that was classed as experimental. All patients were supplied with information sheets about the risks and potential benefits. When published they were also supplied with NICE Guidance (Information about NICE interventional procedure guidance 219 -2007). The Procedure was approved by the hospital Governance Committee.

Patients with clinically diagnosed reflux PTS were assessed with venous duplex,  performed by accredited Clinical Vascular Scientists, to identify deep and superficial venous disease of the affected leg.  All patients went on to have percutaneous dynamic catheter venography, undertaken as a daycase procedure with local anaesthetic access of the right internal jugular vein.  A catheter was used to inject contrast under fluoroscopy to confirm patency of the IVC and iliac venous system.  Venography with the catheter in the affected CFV was undertaken with and without Valsalva to confirm the results of the duplex scan, the presence of reflux and the anatomy of any collateral veins around the common femoral vein.  Depending on the degree of reflux, contralateral leg venography was undertaken to establish the ‘normal’ appearance in that patient.  If the affected leg reflux was faster, in the symptomatic side compared with the asymptomatic side, then this confirmed the duplex findings. Only those with no signs of outflow obstruction (no IVC, Common Iliac or External Iliac vein stenosis) were considered for neo-valve surgery.  The criteria for surgery are shown in Table I.

Procedure

Under general anaesthetic, the CFV and GSV were dissected using a lazy s-shaped groin crease incision.  The CFV was clamped and opened according to the description by Plagnol et al.6  The GSV was transected and ligated distally, from within the wound. The proximal portion of the GSV, still attached to the common femoral vein, was used to create the neo-valve by invagination into the CFV. The tip of the invaginated vein was sutured into place, on the posterior wall of the CFV with 5-0 prolene (Ethicon) to produce the neo-valve, as shown in Figure I. The venotomy was closed with 5-0 or 6-0 prolene.

The whole procedure took no more than an hour to perform and was performed as a daycase.  Oral anticoagulants were not stopped before the procedure, with systemic heparinisation used if the patient were not already on oral anticoagulants. Post operatively patients were fully anticoagulated for a minimum of 3 months using Warfarin or more recently Rivaroxaban. When the latter was used, the medication was administered orally in recovery.

Patient assessment and data collection

The CEAP classification was used to assess overall venous disease state.7  Pre-operative and post-operative PTS was assessed using a modified Villalta score (The modified Villalta required patients to score both symptoms and signs rather than patients reporting symptoms and an observer reporting the signs )8 and the venous clinical severity score (VCSS).9. A Villalta score of ≥5 or the presence of a venous ulcer was indicative of PTS (5-9 denotes mild, 10-14 moderate and 15-33 severe PTS).10  The VCSS was marked out of 30 points. These assessments were used to identify any improvements in patient reported symptoms after neo-valve surgery.  Additionally, the Barthel index (0-100) was used to assess functional disability, commonly used in rehabilitation medicine 11 and reported in post-operative patients to assess morbidity and functional status 12.

Clinical and imaging data were retrospectively collected from the hospital electronic records including; outpatient clinic letters, operating notes, discharge summaries, venous duplex scan and venography reports, along with any other relevant investigations.

All patients were contacted either by phone or post to enable completion of the clinical questionnaires (Villalta and VCSS) after the neo-valve surgery.

This study was an evaluation of clinical outcome of a series of surgical cases, therefore ethical approval was not required.

Statistical Analysis

Pre and post-operative scores were analysed using Wilcoxon signed-rank test.

Patients

Twenty legs (13 left) in 18 patients (12 male), mean age 46 years (range 24-75) had neo-valve surgery.  The mean clinical category (C) of the CEAP classification was 5 (range 3 to 6), with CEAP classification for each leg is presented in Table II. All patients had clinically diagnosed reflux PTS, with a mean duration of 9.75 years (range 2-32 years).   There was active ulceration evident in 10 legs at the time of treatment despite compression therapy.  Venous duplex and venography demonstrated an incompetent GSV, in addition to superficial femoral vein incompetence, in 45% of legs (9/20) ( i.e 55% of patients had a competent GSV. Both competent and incompetent GSVs could therefore  be used to create the valve).  Previous treatment of superficial venous reflux disease (3 foam sclerotherapy, 2 sapheno-popliteal ligation) was reported in 5 legs and two patients were Factor V Leiden heterozygote.

Results

It was possible to create 19 valves but in one patient, when the CFV was opened, there was too much scarring to allow surgery. The venotomy was closed and the patient made an uncomplicated recovery; their symptoms remained unchanged.  An example of pre and post-operative venograms in one patient are shown in Figure II.

Outcomes

The mean time to final follow-up was 3.5 years (range 3 months to 11 years).  Eight of the ten ulcers had healed and the remaining 2 were showing signs of improvement.  Fifteen of the 18 patients (83%) reported an improvement in symptoms following surgery.  Of those without improvement one developed a deep vein thrombosis within 4 days of surgery (thought to be as a result of inadequate anticoagulation with heparin and warfarin). They had no further treatment and their symptoms remained unchanged.  A second patient, with severe lymphoedema following trauma, had no change in symptoms. A third patient suffered from chronic femoral neuralgia but improved calf symptoms.  One patient (aged 75 at operation) died from cardiovascular disease 10 years after the procedure.

Clinical scores

All patients had moderate to severe PTS as measured by Villalta score. The median pre-operative Villalta score was 15.5 (IQR= 14 to 22) and post-operatively it was 8 (IQR= 5 to 15) (P=.001).  There was improvement in the VCSS score from a pre-operative median of 17, (IQR = 11 to 21) to  8.5, (IQR = 5.75 to 15.25, (P=.005)).  The change in Barthels index, although improved, was not significant (pre-op median=85, IQR= 81.25 to 90; post-op median=97.5, range= 90 to 100; P=.083).

Discussion

This retrospective study showed that 83% of patients who had a successful procedure had symptom improvement at a mean of 3.5 years after neo-valve surgery.  It also showed that the neo-valve reduced the severity of PTS as determined by Villalta and VCSS.  Our results are similar to those found by Plagnol et al 6 when a study of 20 patients showed patent and competent femoral veins, in all but one case, at 10 months’ follow-up.  These 2 studies, using the same procedure, suggest that deep vein neo-valve surgery can significantly help symptoms of PTS using a simple technique of inversion of the great saphenous vein into the common femoral vein.

Treatment for PTS is an area under development with surgical techniques broadly being defined into five techniques: Percutaneous interventions such as venoplasty and stenting, venous bypass grafting, endophlebectomy, valve reconstruction/transplant and ligation or injection of perforating veins. There are few randomised trials, but reviews have suggested that surgical management is, potentially, an effective way of treating moderate to severe PTS.13

The creation of a new valve for the treatment of PTS is not a widely described technique so there are few studies with which to compare our results. Maleti’s group14-16 has investigated a technique create a neo-valve from the fibrosis within the vein itself. They report a significant improvement in symptoms and quote an overall success rate of 70% in 40 patients with a follow-up time of seven years. The surgery is more invasive and technically demanding than the neo-valve we investigated. Maleti’s group reported a low post-operative complication rate. They concluded the surgery was a low-risk high benefit procedure however, their data were limited and further studies need to be done to confirm their findings.

Similarly, Hoshino and Hoshino 17 described making a neo-valve by dissecting the vein wall to create a new flap on four limbs with a follow-up time of one month. They describe an improvement on venography and duplex scanning, with a competent neo-valve being observed. They also describe an improvement in PTS symptoms including the healing of leg ulcers.

Although Maleti and Hoshino’s techniques are technically different when compared with Plagnol’s, the creation of a homogenous neo-valve appears to be an effective treatment for PTS.

The Plagnol neo-valve procedure adds to the number of available techniques. It is simple to perform and there appear to be few associated complications. The post-operative DVT and neuralgia complications were in the early phase of the senior author’s experience and changes in practice have meant no further events. The additional pre-operative assessment step of making sure the CFV can be compressed has avoided further problems of not being able to perform the procedure because of extensive femoral vein scarring, although a localised endophlebectomy perhaps could have been done.

Given the results of the operation, it is not clear why Plagnol’s technique has not been widely adopted.  Recent advances in deep vein thrombolysis, stenting of common iliac vein stenosis and recanalisation of chronic venous occlusions may mean that more patients are identified who could benefit from surgery for reflux.

What is not known is the prevalence of reflux post thrombotic syndrome in the general population and how many patients might wish to be considered for corrective surgery. Given it has taken more than 10 years to identify and treat the 20 legs presented, it is possible that there are few patients to benefit.  The Senior Author, in co-operation with colleagues in Haematology, now runs specialist clinics for patients with PTS. Some 10% of patients are ‘anatomically’ eligible for neo-valve surgery but only about 50% have symptoms that are sufficiently lifestyle limiting for them to want surgery.

Conversely, it might be that the traditional teaching that “nothing can be done”, for patients with reflux PTS, means haematologists and vascular specialists are not looking hard enough for patients who can benefit from intervention on their chronic symptoms. Hopefully this study will raise awareness of the condition and the possible treatment options.

It might be argued that patients included in the presented study who had GSV incompetence, would have achieved a similar outcome to neo-valve surgery, if they only had the superficial disease treated.  In this study half the legs treated had no GSV incompetence on duplex or venography which suggests that correction of the deep reflux was an important factor in symptom improvement. Pre-operative plethysmography with and without GSV occlusion might have helped to assess the contribution of each system but the investigation is operator dependent and in the authors’ experience it was  of little value.

An alternative to decide whether simple superficial surgery is adequate would be a randomised trial of GSV ablation versus neo-valve. A drawback to this proposal is that, given the raw material for the neo-valve is the GSV, it would mean one arm of the study would not then be able to cross-over to have the neo-valve as the vein would have been destroyed.

An understanding that neo-valve surgery can help symptoms may be an important consideration for specialists who treat obstructive PTS with iliac vein stent placement. In patients with predominantly obstructive PTS symptoms because of iliac vein stenosis or occlusion, superficial femoral vein reflux may be masked. Iliac stenting may result in some patients converting from obstructive PTS to reflux PTS. These patients might then benefit from neo-valve surgery. The site of placement of the stent in the external iliac vein and proximal femoral vein, subsequent para-venous inflammation and fibrosis could make neo-valve surgery more difficult if not impossible. Interventionalists may need to be aware of this potential problem such that a combined approach might be required with stenting and neo-valve in one procedure. As is frequently the case, comprehensive pre-treatment investigation is essential.

The assessment of the symptoms of PTS is controversial and relies on patient reported outcomes and clinical assessment. Although not perfect, the main method for PTS assessment is the Villalta score 18 and this was used as the primary outcome measure in the recent ATTRACT study 1.  

The study might be more powerful if pre and post-operative duplex scan results were presented and compared. Whilst patients were scanned, it was found that, despite significant symptom improvement, there was still evidence of reflux around the patent neo-valve. Given these findings, post-operative duplex findings appear unhelpful other than to establish that the valve is patent. Research continues to establish a reliable objective measurement but for now, we have to rely on patient reported symptoms and signs.

 

Neo-valve surgery appears to help over 80% of patients with reflux post thrombotic syndrome.  The next step is to determine how many patients might benefit to decide whether it remains a niche procedure or should have more widespread use. The only way to do that is to ask Haematologists and Venous Specialists to look harder rather than turn patients away as appears to be current practice.

Acknowledgements

RJS was in part supported by the Nottingham Vascular Surgery Research Fund, UK and the National Institute for Health Research (NIHR) Collaboration for Leadership in Applied Health Research and Care [East Midlands] (NIHR CLAHRC East Midlands). The views expressed in this article are those of the author(s) and not necessarily those of the NHS, the NIHR, or the Department of Health and Social Care. The funders had no role in the study or the decision to publish.  We would like to thank the staff in the Vascular Laboratory, Nottingham University Hospitals NHS Trust for their assistance with data collection. 

Contributions

BDB designed the study and all authors performed the research.  RJS, LK and LC analysed the data. All authors wrote and revised the manuscript and provided their final approval.

 

References

  1. Vedantham S, Goldhaber SZ, Julian JA, Kahn SR, Jaff MR, Cohen DJ, et al. Pharmacomechanical catheter-directed thrombolysis for deep-vein thrombosis. N Engl J Med. 2017;377:2240-2252
  2. Bulger CM, Jacobs C, Patel NH. Epidemiology of acute deep vein thrombosis. Tech Vasc Interv Radiol. 2004;7:50-54
  3. Rabinovich A, Kahn SR. How i treat the postthrombotic syndrome. Blood. 2018;131:2215-2222
  4. Strijkers RH, Cate-Hoek AJ, Bukkems SF, Wittens CH. Management of deep vein thrombosis and prevention of post-thrombotic syndrome. BMJ. 2011;343:d5916
  5. Maleti O, Perrin M. Reconstructive surgery for deep vein reflux in the lower limbs: Techniques, results and indications. Eur J Vasc Endovasc Surg. 2011;41:837-848
  6. Plagnol P, Ciostek P, Grimaud JP, Prokopowicz SC. Autogenous valve reconstruction technique for post-thrombotic reflux. Ann Vasc Surg. 1999;13:339-342
  7. Porter JM, Moneta GL. Reporting standards in venous disease: An update. International consensus committee on chronic venous disease. J Vasc Surg. 1995;21:635-645
  8. Villalta S, Bagatella P, Piccioli A, Lensing AW, Prins MH, Prandoni P. Assessment of validity and reproducibility of a clinical scale for the post-thrombotic syndrome (abstract). Haemostasis. 1994;24:p. 158a
  9. Rutherford RB, Padberg FT, Jr., Comerota AJ, Kistner RL, Meissner MH, Moneta GL. Venous severity scoring: An adjunct to venous outcome assessment. J Vasc Surg. 2000;31:1307-1312
  10. Kahn SR, Partsch H, Vedantham S, Prandoni P, Kearon C, Subcommittee on Control of Anticoagulation of the S, et al. Definition of post-thrombotic syndrome of the leg for use in clinical investigations: A recommendation for standardization. J Thromb Haemost. 2009;7:879-883
  11. Wade DT, Collin C. The barthel adl index: A standard measure of physical disability? Int Disabil Stud. 1988;10:64-67
  12. Kramer AM, Steiner JF, Schlenker RE, Eilertsen TB, Hrincevich CA, Tropea DA, et al. Outcomes and costs after hip fracture and stroke. A comparison of rehabilitation settings. JAMA. 1997;277:396-404
  13. Bond RT, Cohen JM, Comerota A, Kahn SR. Surgical treatment of moderate-to-severe post-thrombotic syndrome. Ann Vasc Surg. 2013;27:242-258
  14. Lugli M, Guerzoni S, Garofalo M, Smedile G, Maleti O. Neovalve construction in deep venous incompetence. J Vasc Surg. 2009;49:156-162, 162 e151-152; discussion 162
  15. Maleti O, Lugli M. Neovalve construction in postthrombotic syndrome. J Vasc Surg. 2006;43:794-799
  16. Maleti O. Venous valvular reconstruction in post-thrombotic syndrome. A new technique. J Mal Vasc. 2002;27:218-221
  17. Hoshino Y, Hoshino S. The short-term outcomes of neovalve deep venous reconstructive surgery. J Vasc Surg Venous Lymphat Disord. 2015;3:129
  18. Soosainathan A, Moore HM, Gohel MS, Davies AH. Scoring systems for the post-thrombotic syndrome. J Vasc Surg. 2013;57:254-261

 

 

1.     The patient had symptoms that they wanted help with.

2.     The patient had at least skin changes that could be attributable to deep venous incompetence and not superficial venous disease alone.

3.     The patient was fit for General Anaesthesia and was likely to have an improved quality of life as a result of surgery.

4.     The patient was prepared to have major surgery classed as ‘experimental’ and understood that there was a risk of it not working and it could worsen their condition.

5.     The patient had tried conservative measures and had found them ‘intolerable’ or they had not helped (e.g. compression hosiery or compression bandaging to heal ulcer).

6.     The patient had reflux, on duplex scanning, that involved the common femoral vein, deep femoral vein and/or femoral vein.

7.     Duplex scanning demonstrated a patent proximal great saphenous vein. 

8.     There was no evidence of proximal obstruction to venous outflow.

9.     Venography demonstrated reflux in the common femoral vein, deep femoral vein and/or femoral vein

10.  There was no significant scarring in the common femoral vein.

Table I. Patient selection criteria for neo-valve surgery.

 

Patient

Side

CEAP classification

Pre-op VCSS

Post-op VCSS

Pre-op Villalta

Post-op Villalta

1

Right

C34a6sEsAdPr

11

15

19

18

2

Left

C1234absEsAsdPro

21

19

22

20

3

Right

C3sEsAsdPro

12

9

15

8

Left

C236sEsAsdPr

18

6

14

6

4

Left

C136sEsAsdPr

17

11

14

6

5

Left

C34a6sEsAsdPr

nr

nr

nr

nr

6

Right

C1234absEsAsdPr

24

8

24

11

Left

C1234absEsAsdPr

24

8

24

15

7

Left

C1234absEsAsdPr

11

5

14

4

8

Left

C1234absEsAsdPr

14

4

20

1

9

Left

C1234ab6sEsAsdPro

25

20

22

17

10

Left

C34ab6sEsAsdPro

18

16

16

9

11

Right

C1234absEsAspdPro

nr

nr

nr

nr

12

Right

nr

nr

nr

nr

nr

13

Left

C1234a6sEsAsdPr

19

15

14

5

14

Right

C123sEsAsdPr

7

3

12

6

15

Left

nr

nr

nr

nr

nr

16

Left

C135sEsAsdPr

nr

nr

30

nr

17

Left

C3sEsAdPr

7

nr

12

15

18

Right

C34asEsAsdPr

6

8

10

5

Table II.  Pre-operative CEAP classification for 20 legs in 18 patients (patients 3 and 6 had both legs included). nr=Not recorded

Figure I. Technical steps of neo-valve valve reconstruction for post-thrombotic reflux. (a) The saphenofemoral junction has been approached; (b) Creation of a proximal saphenous stump. (c) Invagination of the reconstructed bicuspid valve, which is fixed to the opposite wall of the femoral vein. (d) Suture of the femoral venotomy. From Plagnol, P et al: Autogenous Valve Reconstruction Technique for Post-Thrombotic Reflux, Ann Vasc Surg; 13: 339–342, 1999, with permission from Elsevier.

Figure II. Pre and post-operative venograms of patient with reflux PTS treated with Plagnol’s neo-valve. The Top row images A, C & E were obtained with the patient supine and at rest. The lower images B, D & F are during Valsalva manoeuvre when supine.

A & B are pre-operative venograms, C & D are 2 months post-op; E & F are 36 months post op.   The post-operative images show some minor reflux around the valve. The corresponding duplex scans showed reflux of 1.7seconds duration which was similar to the pre-op reflux duration.

Neovalve Procedure
Neovalve Venogram