V. Treatments
V. Treatments
Giovanni Mosti, Italy
During this session, several accepted dogmas regarding compression therapy were questioned, and new concepts supported by scientific data were presented.
1 – The pressure exerted by the bandage depends on the person applying it rather than the bandage. It has been shown that even experienced nurses may be unable to apply a bandage correctly so that the intended pressure range can be achieved.1
2 – The stiffness of the material is crucial for its behavior. The static stiffness index (SSI) allows one to distinguish between elastic and inelastic material and is calculated by subtracting the supine pressure from the standing pressure.2
3 – In contrast with what has been accepted in the past, stiff material is not associated with a low pressure at rest. In fact, inelastic materials allow both high pressure at rest and high increase in pressure during walking, whereas elastic materials only allow moderate resting pressure with no significant increase in working pressure.3
4 – By permitting a much higher pressure during walking than at rest, stiff or inelastic bandages appear to be able to restore a kind of pump and valve mechanism during exertion.4
5 – Stiff material maintains its effectiveness overtime.5
6 – Graduated compression is not mandatory. It appears that high compression over the calf may be more effective than graduated compression.6
7 – Compression in patients with a mixed ulcer is possible if the perfusion pressure is higher than 70 mm Hg. In such circumstances, compression with inelastic bandages exerting a pressure lower than 40 mm Hg does not lead to a measurable reduction in perfusion, but seems rather to increase the arterial flow by improving the venous pumping function, reducing the venous pressure, and thus increasing the arteriovenous pressure gradient.
Dr Mosti concluded that, whatever the material, pressure and stiffness, compression therapy is always beneficial. Compression with stiff material makes it possible to achieve strong and effective pressure during standing and walking, starting froma lower, more comfortable, supine pressure. Compression stockings, on the other hand, exert a minimal hemodynamic effect and are indicated at the end of the therapy phase, to maintain the results and prevent recurrences.
References
1. Keller A, Müller ML, Calow T, Kern IK, Schumann H. Int Wound J. 2009;6:324- 330.
2. Partsch H. Dermatol Surg. 2005;31:625-630.
3. Partsch H, Clark M, Mosti G, Steinlechner E, Schuren J, Abel M et al. Dermatol Surg. 2008;34:600-609.
4. Mosti G, Mattaliano V, Partsch H. Phlebology. 2008;23:287-294.
5. Mosti G, Partsch H. J Vasc Surg. 2010;52:925-31.
6. Mosti G, Partsch H. Eur J Vasc Endovasc Surg. 2012;44:332-336.
Marc McCafferty, Ireland
Dr McCafferty presented the results of a prospective survey which enrolled 51 consecutive new patients referred to the Vein Unit at St. James Hospital, Ireland, by primary care physicians. The aim of the study was to evaluate the assessment and management of chronic lower limb ulceration in the community. The results showed that mean time from ulcer management in the community to referral was 8 months (2 weeks-60 months), and two-thirds of these patients did not have a working diagnosis referral. Clinically, 70% of patients were considered to have venous ulcer and treated with full compression, 74% of these cases did not have compression prior to referral, or they had compression that was discontinued or inadequate. Four months follow-up was completed in 85% of cases, 72% were fully healed, and 2% of cases did not improve. The authors conclude that management of lower extremity ulceration in the community remains suboptimal. Additional education is required to ensure accurate diagnosis and management. When community ankle-brachial index testing is not available, criteria for the safe use of compression therapy should be instituted. Earlier referral of nonhealing ulcers should also be encouraged.
Alfred Obermayer, Austria
After a brief presentation of the duplex “sourcing” technique as a way of detecting the responsible superficial reflux routes (eg, post-thrombotic syndrome and peripheral arterial disease), Obermayer discussed surgery in patients with venous ulcers. He considered that “Single-shot surgery” is a good standard for treating recalcitrant venous ulcers, although it is not internationally accepted. The technique enables and accelerates ulcer healing, with evidence for this approach provided by the ESCHAR randomized controlled trial.
Fedor Lurie,USA
This paper presented the results of the 6th Pacific Vascular Symposium (PVS), which took place between 12th and 15th November 2009. The aim of the PVS was to initiate collaborative effort, aimed at a practical and achievable goal: to decrease the prevalence of venous ulcers by 50% in 10 years. The results were multiple: critical issues, practical solutions, landmarks of success and calls for action. PVS established many priorities: awareness of venous ulcers and chronic venous disease, both professionally and for the public; and standardization of CVD diagnosis (practical and reproducible ultrasound scans to identify axial/segmental reflux and obstruction, noninvasive and invasive diagnosis of iliac obstructive disease, and collaboration with Wound Care Centers to diagnose and treat venous ulcers by these standards). Another priority of the PVS was to change the therapeutic behavior of C4-C6 patients: compression for control of venous/lymphatic swelling, correction of superficial axial reflux, perforator reflux and treatable deep vein obstruction, and last but not least, surveillance for progressive axial reflux, and compliance with compression and pharmacologic management of anticoagulation for various stages of CVD. Another topic debated was the prevention of postthrombotic syndrome. This requires provision of appropriate compression, ambulation, and anticoagulation for acute deep venous thrombosis (DVT), prevention of recurrent DVT, early thrombus removal in patients with iliofemoral DVT, and elimination of postthrombotic iliocaval obstruction. The PVS also paid special attention to research, and in particular an initiative to determine the prevalence of venous ulcers over the next 10 years, defining the natural history of primary disease progression from C2 to C6, and the effect of early intervention to prevent this progression. A PVS action plan for the coming 5 years (2010-2015) was also conceived.
Thomas O’Donnell, USA
Clinical Practice Guidelines are “systematically developed statements to assist practitioner and patient decisions about appropriate heath care for specific clinical circumstances.” “The need for an Intersociety Consensus Guideline for venous ulcer” was published in the Journal of Vascular Surgery in 2011 by Thomas O’Donnell and Ethan Balk. It presented the compulsory stages in guideline development and discussed several aspects of the prevention and treatment of venous ulceration, as well as levels of recommendation: strong recommendation (high degree of agreement), weak recommendation (low level of agreement), and areas of “controversy.” The author concluded that it is imperative for specialty societies to collaborate and develop a consensus document on venous ulcers.
Oscar Bottini, Argentina
In South America, the prevention and treatment of venous ulceration was disadvantaged because of disparities in diagnosis and treatment criteria, a lack of objective and local data, a lack of statistics and epidemiology, and in particular, no strong consensus recommendations based on scientific evidence. Starting out with this reality and using models such as the Spanish National Consensus Conference on Lower Extremity Ulcers (CONUEI, 2006), the Pacific Vascular Symposium Consensus (2010), and the American Venous Forum Consensus (2011), consensus guidelines for the prevention and treatment of venous ulceration have now been developed for South America. The project was started in 2010 and published in 2013. The implementation of this Consensus should lead to the prevention, fast diagnosis, and correct treatment of venous ulceration in South America.
Mitchel Goldman, USA
The author reviewed the main sclerosant substances currently in use. He briefly reminded the audience of their mechanism of action, therapeutic indications, secondary reactions, and their efficacy as demonstrated by clinical trials. He also established some sclerotherapy rules, the most important of which seems to be first the elimination of high-pressure reflux, and second the treatment of small varicose and reticular veins with associated telangiectasias on the same day. To the question “How do we select the type of sclerosant, the sclerosant concentration and volume?” his answer was the following: “by consolidating, of course, the data in the specialty literature and broad personal experience.
Sclerosant is what you are comfortable with, concentration depends on the size and type of vein and the volume depends on the size and diameter of the vein.”
Robert Weiss, USA
The focus of this presentation was that reticular veins must be treated for successful management of associated telangiectasias. Treatment of the former also reduces side effects such as pigmentation by reducing venous pressure. New telangiectasias appear when compression of reticular veins has not occurred.
Albert Adrien Ramelet, Switzerland
Although a study by Nootheti from 20091 confirms that wearing medical compression stockings (MCS) for longer after sclerotherapy of telangiectasias improves results, phlebologists worldwide still have different opinions, and some patients continue to be denied the use of MCS. Several hypotheses have been proposed for the mechanism of action of MCS. Based on the results of several clinical studies published in the specialized literature, Ramelet asserts that MCS should be proposed for all patients after sclerotherapy of telangiectasias, because the wearing of MCS (for an additional 3 weeks after sclerotherapy treatment) improves clinical vessel disappearance, avoids treatment failures, and reduces the incidence of pigmentation.
Reference
Nootheti PK, Cadag KM, Magpantay A, Goldman MP. Efficacy of graduated compression stockings for an additional 3 weeks after sclerotherapy treatment of reticular and telangiectatic leg veins. Dermatol Surg. 2009;35:53-57.
Neil Sadick, USA
Laser therapies were presented by the author as viable alternatives to sclerotherapy. Pulsed dye lasers are considered by Sadick as a gold standard for the treatment of facial telangiectasias, hemangioma, and port wine stains. External laser therapy is recommended for non-cannulisable leg veins, and can be used in combination with liquid sclerosing techniques. Endovascular Laser Therapy (EVLT) is recommended for axial vein incompetence. The combination of EVLT with foam sclerosing techniquse or ambulatory phlebectomy is also possible. For best results, sclerosants should be combined with long-pulsed Nd:Yag lasers. EVLT is the optimal treatment for axial varicose veins (ie, long or short saphenous veins).
Jean-Luc Gillet, France
Although foam sclerotherapy (FS) is a safe and effective treatment for varicose veins, specific complications and neurological symptoms related to its use such as visual disturbances and cerebrovascular events have been reported. Visual disturbances after FS correspond to migraine aura and have been related to a spreading depression of cortical activity caused by release of endothelin and microemboli. The disturbances are not secondary to a transient ischemic attack. These auras are fully reversible visual, sensory, or dysphasic speech disturbances.
Cerebrovascular events following FS can be secondary to specific complications of FS treatment, but can also appear with other endovascular ablative events (RFA, EVLA), as well as liquid sclerotherapy. The time of onset after the procedure differs for paradoxical clot embolism (delayed onset of symptoms) and paradoxical gas embolism (immediate onset). Such events can be prevented by the use of more viscous foam, limiting volume, and avoiding Valsalva maneuvers after treatment.
While millions of FS sessions have been performed, no deaths from stroke have been described, and only a few cases of stroke related to air embolism, with complete or near complete recovery have been described.
Takashi Yamaki, Japan
A patent foramen ovale (PFO) is present in half of the population and is related to the risk of foam sclerotherapy (FS) complications. The aim of our study was to minimize foam migration, compare multiple injections of low dosages (< 0.5 ml of 15 POL foam) versus a few large volume injections (>0.5 ml), and monitor the presence of foam in superficial veins (great and lesser saphenous) and the deep system (common femoral, femoral, popliteal, anterior and posterior tibiae vein, and perforating veins) with ultrasound.
The study findings indicate that multiple small-dose injections can reduce the amount of sclerosant foam entering the deep veins. Higher volumes have superior efficacy, but promote venous spasm that can cause migration of foam via perforating veins to the deep venous system.
Alessandro Frullini, Italy
Deep venous thrombosis risk can be 1 in 455 after foam sclerotherapy according to Myers, although this figure varies slightly in other studies. The indications for foam sclerotherapy are changing, and there is a trend to treat increasingly larger veins in office procedures (a procedure that may increase risk in case of adverse events). For this reason, prophylaxis can be an option.
Adverse events may be related to allergic reactions and microbubble embolization and endothelin release. They can also be related to the presence of right-to-left shunt (patient foramen ovale [PFO]), incomplete spasm of the treated vein, patient variability responses to endothelin release, and interaction with other coagulation substances with anti-endothelin activity (vasodilators and cardiovascular drugs). PFO can elevate risk, as we know now, because the lung bed is a scavenger for emboli and for endothelin release. When instituting prophylaxis, coagulation disorders and endothelin release should be considered. Since the author has started using prophylaxis, the rate of neurological and visual disturbances has decreased from 1.11% to 0.16%.
In extensive sclerotherapy one can use nadroparin (once daily), aminaphtone 75 mg/12 hours starting 3 days before sclerotherapy and continuing until the sclerotherapy cycle ends, and cetirizine 10 mg 1 hour before sclerotherapy. For minor sclerotherapy the use of low molecular weight heparins is not necessary.
Stephen Guggenbichler, Germany
In several studies, complications related to foam sclerotherapy appear to be dosage dependent. In 2008, Myers concluded that the incidence of venous occlusion rises with higher volumes of foam, veins greater than 5 mm, and sclerosant concentration. In 2006, Wright had to change the Varisolve study protocol (up to 60 ml) because of a higher rate of thrombotic events. The relationship between neurological effects and dosage still remains unclear.
There is only a small amount of evidence that foam volume is related to safety, but 15 years of experience in Europe in which the amount of foam has been limited to under 10 ml per session has shown that it is safe. Volume should therefore be limited for safety reasons. It is better to increase the number of sessions and not the volume in one session.
The term “sclerosophy” aims to control varicose vein disease with multiple injection sessions of small volumes. The safety of the method is the most important factor.
Andrew Bradbury,UK
In the Varisolve study there was a high rate of deep venous thrombosis (DVT) (2.5%), but usually the risk of thrombosis with foam sclerotherapy is lower (Birmingham experience, 1027 patients, 3 proximal DVT and 1 pulmonary embolism; Cheltenham, 776 patients, 17 DVT (1.5%) and 1 pulmonary embolism).
However, the majority of thrombotic events are asymptomatic, limited, and can be considered as echography findings.
For this reason, ultrasound control of the whole deep system is not cost-effective, because clinically significant DVT is very rare with homemade foam. The number needed-to-scan to detect one DVT is >150 and the cost for a detected DVT is higher than $50000. In addition, the timing of DVT is variable, with a single scan the protocol would be inadequate. The benefit of performing duplex screening is therefore uncertain.
Katy Darvall, UK
In general, there are few complications in studies that have compared physician generated air-based foam with manufactured foam. The low frequency of side effects prevents statistical analysis.
There are insufficient data to determine the best methodology for performing foam sclerotherapy including the differential preparation of foam with sclerosant and gas mixtures, as well as injection techniques.
Attilio Cavezzi, Italy
At present we do not have enough evidence to make any claims in terms of safety. We can produce foam with more efficacy, and this improved efficacy could promote better safety, but we need more data to reach any conclusions.
In terms of efficacy, smaller bubbles have a higher active surface of foam in the vein wall and a longer half-life, which increases the amount of contact with the venous wall.
In terms of safety, smaller bubbles could have a lesser impact in the pulmonary or cerebral circulation, and faster reabsorption.
The material used can alter the stability of the bubbles. The best results are achieved with silicon free syringes, and the best combination using the Tessari technique is BD Discardit 5 ml + Terumo 2.5 ml. When using air, smaller syringes produce smaller bubbles. Using air or soluble gases, smaller syringes produce longer-lasting foam. The use of 21 to 25 G needles will not denature foam, but 27G will. The use of 4F catheters does not denature bubble size or foam duration in a significant manner.
Douglas Hill, Canada
To decrease foam migration and its effects (neurological events such as stroke, seizure, transient ischemic attack, migraine and thrombotic events) we should take several precautions: identify patients at risk, limit foam volume, post-injection immobilization, avoid Valsalva, block the foam in the target area and the junctions with the deep system with the probe, attempt to remove the foam, use physiologic gas, and leg elevation (decreases the volume of the target vein and limits the volume required to refill the vein). In addition, one should remember that elderly patients seem to be more vulnerable to the effects of foam migration.
Pauline Raymond-Martimbeau, Canada
Can we improve the outcomes of patients by defining the utility of pretreatment testing for right-to-left shunt? Is there any supporting, scientific opinion-based evidence to warrant pretreatment testing? What is the strength of the evidence?
In a systematic search of the literature the author identified 1038 articles, but only 45 studies were of interest. The overall number of patients was 11,236. There were 142 cases of visual disturbance and migraine (1.26%), 6 cases of transient ischemic attack and reversible ischemic neurologic deficit (0.05%), and 13 cases of stroke (0.001%). Most of these events were related to female gender (70%), mean age 45 yrs (33-72), and 72% associated with large veins (great saphenous vein, small saphenous vein, and perforating veins). The majority of patients had no residual deficit and most cases of embolism were confirmed to have right-to left shunt (PFO).
There are no randomized studies to answer the question and thus, it is impossible to assign a high or even a moderate quality of evidence to any of the questions dealing with this issue, because evaluation is mostly based on case reports. There is no grading of PFO and there is a lack of consistency in reporting the details of the gas and technique used.
Air emboli occur in other therapeutic procedures in whom pretesting for PFO is not warranted (neurosurgery, laparoscopy, hip artroplasty, central line catheter placements, cesarean and gastric endoscopy).
The wide use of sclerotherapy with very low neurological complications, with no evidence of death or major stroke, indicates that sclerotherapy is safe and effective. Pretreatment testing for right-to-left shunts is therefore not warranted for people without symptoms. It can pose a risk, may not be conclusive, and can add expense.
Pre-screening for PFO is only warranted in patients at risk of PFO (history of cryptogenic stroke, severe migraine with aura, sleep apnea, platypnea orthodeoxia, stroke with chronic obstructive pulmonary disease, and pulmonary hypertension and severe comorbidities).
Pro – Philip Coleridge Smith, UK
Con – Andre van Rij, New Zealand
PRO: Coleridge Smith began by talking about patients who are more informed, desire minimal postoperative visits, and a rapid return to normal activities. He described a retrospective questionnaire that was given to patients undergoing surgery, radiofrequency (RF), ablation, laser and foam sclerotherapy to provide insight on how patients felt.
In response to the question about how many days after varicose treatment patients took pain killers, the answer of the foam group was only 1 day, the RF group, 1-12 days, and the laser group, 10-14 days. When asked how soon they returned to work after varicose vein treatment, the response of the sclerotherapy group was the same day, the surgery group after 5 days, and the RF and laser group, after 14 days.
In defense of foam sclerotherapy, Coleridge Smith argued that it is the least technical treatment, with the lowest costs, and is acceptable to patients under most circumstances.
Further reading:
Rasmussen LH, Lawaetz M, Bjoern L, Vennits B, Blemings A, Eklöf B. Randomized clinical trial comparing endovenous laser ablation, radiofrequency ablation, foam sclerotherapy and surgical stripping for great saphenous varicose veins. Br J Surg. 2011;98:1079-1087.
Gohel MS, Epstein DM, Davies AH. Cost-effectiveness of traditional and endovenous treatments for varicose veins. Br J Surg. 2010;97:1815-1823.
Shadid N, Ceulen R, Nelemans P, et al. Randomized clinical trial of ultrasoundguided foam sclerotherapy versus surgery for the incompetent great saphenous vein. Br J Surg. 2012;99:1062-1070.
Bradbury AW, Bate G, Pang K, Darvall KA, Adam DJ. Ultrasound-guided foam sclerotherapy is a safe and clinically effective treatment for superficial venous reflux. J Vasc Surg. 2010;52:939-945.
CON: Prof Van Rij began his presentation by discussing the 2004 Cochrane systematic review by Rigby KA et al. The paper highlighted that there are huge variations in practice, demonstrating high levels of recurrence after foam treatment, the need for multiple treatments, deep venous thrombosis, thrombophlebitis, pigmentation, matting, arterial injection, and lack of control. He asked important questions about who is in charge of treatment: the physician, the researcher, the purchaser, or industry; and who should treat the patients: the surgeon, the dermatologist or the phlebologist? He also highlighted patient expectations: quality of life, cosmetic results, and no complications of the procedure.
At 5 years, surgery produces better results than foam treatment for people with confirmed varicose veins and truncal reflux. Foam is not usually Prof Van Rij treatment of choice.
Further reading:
Rigby KA, Palfreyman SSJ, Beverley C, Michaels JA, Surgery for varicose veins: use of tourniquet (Review). Cochrane Database of Systematic Reviews. 2004; Issue 4.
Pier Luigi Antignani, Italy
This study presents the results of a study performed in 73 elderly patients (68-85 years old), suffering from severe chronic venous insufficiency (C4-C6). The results showed that foam sclerotherapy was an effective, safe, and well-accepted treatment for improving the clinical conditions in patients suffering from chronic venous insufficiency by reducing the symptomatology (assessed with venous clinical severity score [VCSS] and venous disability score [VDS]), and by improving quality of life (SF-12 questionnaire).
Paolo Casoni, Italy
The aim of the foam in this technique is to induce sclerosis outside the vein rather than inside, in order to create a “perivenous fibrosis.” The foam sclerosing effect is achieved in the lymphovenous layer and its extravasation in perivenous tissues is well tolerated. In addition, as the groin region is rich in veins or lymphatic-venous anastomosis; foam treatment around puffy or aneurysmal veins can induce the vein to regress to normal caliber.
Inclusion criteria for this treatment are patients with clinical varicose veins contraindicated for surgery, with great saphenous vein terminal reflux and aneurismal junction (>10 mm). An echo-guided evaluation was performed before and after foam was injected at two points, above and below the saphenofemoral junction.
The treatment was performed in 20 patients with no complications, but with poor results. Varicose veins disappeared in two patients, and in seven patients vein caliber decreased, but reflux remained although it was decreased.
In the authors’ opinion, perivenous injection is useful only in 35% of cases, and probably only in those in whom real adventitia injection is achieved.
Patrizia Pavei, Italy
When should recurrent varicose veins be treated? In the author’s experience the two reasons for retreatment are the appearance of symptoms and complications. All recurrent varicose veins can be separated into two general types. (a) Neovascularization. These varicose veins are usually fragile, and easy to treat with foam sclerotherapy (0.5%-1% concentration using 4-10 ml per session). The author’s success rate in 142 patients was 91%. (b) Recurrences at saphenofemoral or saphenopopliteal junctions. Reperforming surgery is associated with a 70% recurrence rate. Thus, in these cases, ultrasound guided foam sclerotherapy is a better option. If the varicose vein diameter is larger than 8 mm, treatment may require 1-3 sessions of 4-10 ml of 1%-3% STS foam. The results at 1 year are 87% complete occlusion, with complete occlusion remaining in 85% of patients at 2 years, and 80% at 3 and 5 years.
In conclusion, for varicose recurrence, foam sclerotherapy is the treatment of choice for neovascularization, and can be considered for recurrences emanating from junctions, where it may be combined, if necessary, with phlebectomy.
Alessandro Frullini, Italy
LAFOS is an office-based procedure, which is painless and does not require anesthesia, and which can be an alternative to isolated endovenous laser ablation (EVLA) or foam sclerotherapy (FS).
Holmium laser does not affect the intima. It only acts on the media, where its thermal effect causes shrinkage of tunica media type III collagen fibers. Thus, complementary sclerotherapy to reduce lumen size by laser action can enhance the results of FS and the amount of foam required compared with classical FS.
In our experience with 100 cases (38 great saphenous [GSV] and 12 small saphenous vein [SSV]), 100% were successful at the first follow-up examination. Two veins needed direct injection of foam because they were not fully ablated.
There are not enough data on late follow-up outcomes, but LAFOS could be a good option for GSV/SSVs resistant to foam sclerotherapy for several reasons: less expensive (office-based, faster, no anesthesia); makes sclerotherapy more technological; vein shrinkage results in a requirement for less foam volume; media pretreatment could be feasible in large veins, and fewer postoperative recurrences.
Maurizio Ronconi, Italy
It is estimated that 5% of the population is affected by hemorrhoids. Surgical treatment is aggressive and has a high rate of recurrence. Foam sclerotherapy can improve outcomes.
The technique is performed without sedation, an oxypulsometer is the only monitoring required. The patient is placed in the left lateral decubitus position and the puncture is made after rectal endoscopic exploration. The amount of foam in each globe is 3 ml, up to a maximum of 8 ml in each session. If required, a new session is performed after 3 weeks. The mean number of sessions required is three.
In the author’s experience with 290 patients with rectal bleeding, 210 were treated with 765 procedures (mean 3.6 procedures per patient), with a median followup of 12 months. There was disappearance of bleeding in 83% of cases and local complications were found only in 5% of cases.
Foam sclerotherapy of hemorrhoids is a simple, painless and feasible treatment with good results. The recurrence rates are not yet known.
Alun Davies, UK
The treatment of patients with superficial venous reflux has changed in recent years following the widespread acceptance of minimally invasive, endovenous modalities including ultrasound-guided foam sclerotherapy (UGFS), endovenous laser ablation (EVLA), and radiofrequency ablation (RFA). The treatment of symptomatic varicose veins has been demonstrated to improve quality of life (QOL), alleviate symptoms of depression and treat the complications of venous disease. Current evidence suggests that the treatment of varicose veins in all stages of symptomatic diseases is cost-effective.
The first point to consider when comparing the effects of the different therapeutic options is that the wide range of clinical situations in chronic venous disease (CVD) can make us think we are not always treating the same disease. In CVD there are multiple different anatomical and clinical pathways.
The second point is the variable methods used to measure outcomes: anatomical, hemodynamic, clinical, or functional, or based on combined criteria; a situation that increases the heterogeneity of reporting standards. Problems encountered when comparing treatments in a series are the mix of different patients and different outcomes. For this reason, in the majority of recent studies (Rasmussen, Davies), excluded subjects comprise nearly 50% of patients in order to achieve homogeneous results.
Most of the reported results for patients treated with different techniques are similar, with no significant differences, or only slight ones.
QOL appears to be an objective tool, but differences between treatments are slight, and populations with CVD have worse QOL scores than other diseases. There is also no significant difference in QOL in one technique over another. Thus, differences between techniques may have slight variations, and some may be more related with reimbursement issues than with real patient preferences (eg, local anesthesia, office-based treatment).
Occlusion rates at 1 year are similar for the different options, but RFA seems to be associated with less postprocedure pain and a faster return to work, and therefore a better cost-effectiveness analysis compared with surgery and EVLA. UGFS remains the cheapest option, but is associated with a significantly higher recurrence rate at 1 year.
The suggested options for varicose vein treatment by the NHS guidelines in the UK (NICE) are, in this order: RFA, laser, foam, and open surgery as a last option. The options may be different in other situations and other countries.
Varicose veins have a multitude of treatments options and all can provide excellent improvements in QOL at a cost-effective level. Overall costs have fallen dramatically despite material requirements, and no patient should be without a treatment option. This idea can be summarized as “different treatments are different in different patients”.
Fausto Passariello, Italy
Both ASVAL (Ambulatory Selective Vein Ablation under Local Anaesthesia) and CHIVA (Ambulatotory Conservative Haemodynamic Management of Varicose Veins) are conservative strategies for the treatment of chronic venous insufficiency (CVI). ASVAL involves ambulatory phlebectomy of all varicose tributaries with preservation of the great saphenous vein and small saphenous vein, irrespective of their competence. The principle of CHIVA is to decrease the superficial venous pressure. The aim of CHIVA is not only to preserve the greater saphenous vein for use as a future vascular graft, but also to maintain its drainage eliminating reflux points.
Erika Mendoza, Germany
The four principle aspects of the technique were explained: interruption of the venovenous recirculation, fragmentation of the hydrostatic column, preservation of the reentry perforators, and deletion of the incompetent tributaries. Several studies have been published on the long-term results achieved with CHIVA, and a Cochrane review has been published – the CHIVA method reduces varicose vein recurrence and produces fewer side effects than vein stripping. However, these conclusions are based on a small number of trials with high risk of bias. New, randomized controlled trials are required to confirm these results and to compare CHIVA with other methods.
Paul Pittaluga, France
The ASVAL method is based on the concept of an ascending evolution of varicose disease. The theory has two presumptions: early treatment of varicose veins is useful to prevent spreading to the saphenous vein (if there is no saphenous reflux), and therapy should include ablation of the varicose reservoir, and not the ablation of the saphenous vein itself in which reflux is potentially reversible (saphenous stripping would only be indicated in cases where saphenous reflux is irreversible). Medium-term results (303 lower limbs) with ASVAL showed a major improvement in saphenous hemodynamics in 90% of cases compared with preoperative values at up to 4 -years of follow-up. Two other prospective studies have shown a significant effect of phlebectomy on reduction of the diameter of the saphenous vein. However, the indications for ASVAL treatment need to be refined with longer follow-up and randomized controlled trials.
Pro – Massimo Capelli, Italy
Con – Fedor Lurie, USA
PRO: Massimo Capelli advocated sparing the saphenous vein not only for future use as a conduit for arterial bypass, but because preserving the saphenous trunk leads to a reduction of varicose recurrences over time. He pointed out that because the average age of the population is increasing as well as the incidence of arterial pathology, the probability of using veins as grafts will also likely increase.
CON: Fedor Lurie stated that the great saphenous vein (GSV) should be spared only in a very few selected cases of patients with existing severe peripheral arterial occlusive disease. The rate of coronary revascularization has decreased by 38%, and currently GSV is used in less than 10% of coronary artery bypass graft operations. Furthermore, less than 1% of patients with arterial disease need revascularization.
Arkadiusz Jawien, Poland
The discussant pointed out that the preservation of the saphenous trunk is not the basis, but only one of the results of CHIVA or ASVAL. He also noted that only 0.3% of surgeons performed CHIVA as shown in a survey among 675 surgeons of the French speaking Vascular Surgery Society.1
Reference
1. Perrin M, Guidicelli H, Rastel D. Surgical techniques used for the treatment of varicose veins: survey of practice in France [in French]. J Mal Vasc. 2003;28:277- 286.
Pro – Massimo Capelli, Italy
Con – Fedor Lurie, USA
One of the most controversial subjects in phlebology is saphenous sparing procedures, of which there are two: CHIVA and ASVAL. Their supporters do not ablate or remove the great or small saphenous vein. CHIVA is based on certain principles referred to as the “hemodynamic approach” by it supporters.
PRO: The “pro” speaker Massimo Cappelli (Italy) defined a hemodynamic approach. It is a correction of the pathological changes caused by superficial venous reflux with simultaneous preservation of the saphenous trunks and tributaries. This can be achieved by ligation of trunks and branches in certain crucial points. M. Cappelli’s arguments were: (1) we need to spare saphenous trunks for possible future arterial bypasses; (2) a ligated but preserved trunk serves as an effective draining system, which prevents recurrences; and (3) in case of future deep venous thrombosis, the spared trunk can become a collateral pathway. The most contradictory argument is the second one.
In summary, a hemodynamic approach to ablation of saphenous trunks leads to enlargement of other veins to drain tissues, and dissection of perforating veins results in opening of new ones to evacuate blood from outside to deep veins.
CON: The “con” speaker, Fedor Lurie (USA) challenged the idea of referring to hemodynamics itself. He drew the audience’s attention to the many contradictions in our knowledge of hemodynamics: reflux does not always cause varicose veins, reflux does not always cause symptoms and signs, and correction of hemodynamics does not always eliminate symptoms, reverse skin changes or edema, neither does it prevent progression of disease. He stated that there is no clinical evidence to support a hemodynamic approach. A further point of discussion was the lack of data on what happens in the venous system in reality, ie, while not performing duplex ultrasound. The theory that ambulatory drops in deep venous pressure cause changes in blood flow in the superficial veins may not stand. The different changes that occur in the deep and superficial valves in primary disease cannot be explained by current data. The remodeling of the venous wall is not an adaptation to hemodynamic changes, but a nonreversible phenomenon. F. Lurie’s conclusion was that hemodynamic changes are the result, not the cause of the disease. Therefore, while treatment is necessary, it cannot stop the process.
Take-home message: The hemodynamic approach is an original and often effective treatment strategy with some contradictory principles. We are still lacking the data to explain the origin and peculiarities of hemodynamic changes in primary chronic venous disease.
sedation: 5 year experience with 12-month follow-up
Haroun Gajraj, UK
In this study, the author investigates the outcome of a policy of treating bilateral saphenous reflux and varicose veins in one session, under local anesthetic without sedation, by a combination of endovenous thermal ablation, phlebectomy, and foam sclerotherapy.
The author treated 207 patients with bilateral saphenous reflux with C2-C5 clinical conditions from February 2007 to January 2012. The medium operating time was 90 minutes, treating in some cases very large varicose veins.
At 12-months follow-up, 185 patients (92%) had successful treatment of bilateral saphenous vein reflux and associated varicose veins in a single session, and 95% of the patients were very satisfied with the results. The time in hospital was 4 hours for the majority of cases. The author indicated that it is possible to treat patients with bilateral saphenous reflux with local anesthesia without sedation.
varicose veins
Lotte Engels, The Netherlands
The results of the MAGNA study comparing endovascular laser ablation (EVLA), conventional stripping (CS) and ultrasound-guided foam sclerotherapy (UGFS) for great saphenous varicose veins concluded after 1 year of follow-up that EVLA is as effective as CS, and superior to UGFS, according to occlusion on ultrasound duplex. Quality of life significantly improved after treatment in all groups.
Nicos Labropoulos, USA
MAUDE (MAnufacturer and User facility Device Experience) is an open, voluntary national US database and was used in the current study to analyse the complications of endovenous ablation. A total of 349 adverse events relating to laser or radiofrequency ablation reported between January 2000 and June 2012 were analyzed. Outcomes of interest were pulmonary embolism, deep vein thrombosis, death, and device failure (42% of reported events). More complications were related to radiofrequency compared with laser. There were 7 (2%) periprocedural deaths, all from pulmonary embolism. The author concluded that risks of endovenous procedures tend to be overlooked, and that the reported events represent only a fraction. Further investigation is warranted.
Demetris Kontothanassis, Italy
Long-term endovascular laser ablation results from the ELAFOS study (59 patients with a minimum of 5 years of follow-up) showed a low recurrence rate and good occlusion rates. There were 2 (3.4%) partial, and 3 (5.1 %) complete recanalisations at the last follow-up. Residual disease was detected in 7 (11.9 %) patients, and new disease developed in 20 patients (33.9%), but only a few patients were symptomatic.
Thomas Proebstle, Germany
The first results of the eSCOPE study (prospective multicenter observational cohort study) on the efficacy of a novel greater saphenous vein ablation technique based on cyanoacrylate adhesive were presented. A total of 70 patients were included and the primary end point at 6 months was duplex ultrasound-proven vein closure with a lack of pathological reflux (anatomical success). At 2-day follow-up, 70 patients showed complete occlusion. Partial recanalization was reported at 3 months in three cases, and in one additional case at 6-months follow-up. Average venous clinical severity score improved from 4.3 ± 0.3 at baseline to 1.3 ± 0.16 at 6-months follow-up. The method proved to be feasible, safe and effective without the use of sedation, tumescent anesthesia, or compression stockings. No paresthesia was observed, but midterm results are expected.
Hayley Moore, UK
Patient follow-up practices after varicose vein interventions are changing in the UK as general practitioners (GPs) are now seeing many of these patients. In this study, the authors completed an online survey program among patients, surgeons, and GPs before the interventions were performed to assess how, where, and by whom they feel the intervened patients should be followed up.
The survey was conducted in 2012 and answers were obtained from 47 patients, 110 surgeons (65% vascular surgeons), and 112 GPs. Only 19% of patients did not expect a routine follow-up by someone; moreover, the vast majority of them anticipated a postoperative visit to a member of the surgical team, compared with only 36% of surgeons and 51% of GPs. Meanwhile, when complications occurred, both patients and medical professionals almost unanimously agreed that the surgical team should follow those patients up. Among the GPs, 42% felt confident about following up patients, assuming additional funding was provided; 21% felt they needed more training; and roughly a quarter did not wish to follow up these patients at all.
These UK survey results highlight that if follow-up practice after varicose vein procedures is moving toward GPs, or even no follow-up, additional patient and GP education measures should be considered to ensure safety and patient satisfaction.
radial EVLA (1470 nm) versus RFA closure fast
James Lawson, the Netherlands
The author compared the effectiveness of endovenous laser ablation (EVLA) (1470) versus radiofrequency ablation (RFA) in the treatment of great saphenous vein reflux. A prospective study was performed by the author between October 2010 and August 2012, in a single center. Three hundred and fifty great saphenous veins in 312 patients were randomized for EVLA (174) or RFA (177).
No difference in visual analog score for pain was observed during the first 14 days. Partial recanalization was observed in one patient after an RFA procedure and total recanalization in one patient after an EVLA procedure. Clinical and quality-of-life improvements were similar after 2 weeks and 12 months for the two treatments.
Mark Meissner, USA
In the author’s opinion, the historical view of superficial venous thrombosis (SVT) may not be entirely accurate. Many colleagues believe that SVT is a benign disease with a spontaneous resolution. But in fact there is at least a 20% incidence of concurrent deep venous thrombosis and/or pulmonary embolism. In addition, 43% of them are noncontiguous. There are many areas to be determined, from risk factors to treatment strategies and optimal end points.
Russel Hull, Canada
Not many studies have been published on this subject. What we know today is that the risk of SVT is six times higher for FV Leiden mutations, four times higher for the FII G20210A mutations, and 13 times higher for the combination of ATIII and protein C and protein S deficiencies. Routine testing for thrombophilia should not be considered for SVT in varicose patients, but in cases of spontaneous onset of the thrombosis there should be a lower threshold for such testing.
Ted King, USA
The presentation was mainly based on the European Consensus Statement on SVT published in 20121. Despite a lack of randomized controlled trials, the document recommends the use of both compression and nonsteroidal anti-inflammatory agents in patients with SVT.
Reference
1. Kalodiki E, Stvrtinova V, Allegra C, et al. Superficial vein thrombosis: a consensus statement. Int Angiol. 2012;31: 203-216.
Suman Rathbun, USA
Many use anticoagulation agents in daily practice with good results. However, there is still no high quality scientific evidence on which agents and regime should be used. Only six studies have been performed. The largest was CALISTO, which proved the efficacy of fondaparinux for 45 days. Whether it can be extrapolated to low molecular weight heparins is unknown. The cost-effectiveness of this treatment should also be questioned.
The current place of surgery for SVT remains controversial. Carlos Simkin (Argentina) and Imre Bihari (Hungary) attempted to formulate clear indications for the ligation of saphenous trunks. A protrusion of the thrombus from the saphenofemoral or saphenopopliteal junction into the deep vein system can be regarded as mandatory. Other indications, such as location of a thrombus near the saphenous trunk junctions were questionable. This was also confirmed by Sylvain Chastanet (France) in a concluding presentation. He described recent data from a posthoc analysis of the CALISTO study, which found no difference in deep venous thrombosis/pulmonary embolism in patients with a thrombus at 3 cm or less from the saphenofemoral junction. What needs to be addressed in the future are criteria for identifying higher risk populations that could result in more targeted and thus cost-effective treatment of acute SVT. The role of new anticoagulants should also be studied.
Anticoagulants appear to be effective in SVT, but this needs to be demonstrated in more large randomized controlled trials. Surgery is indicated in some situations, but currently has a limited role in SVT.
Peter Henke,USA
The incidence of deep venous thrombosis (DVT) is high and is estimated to be between 250 000 to 900 000 patients/year in the USA.
At the vessel wall level there is a balance of thrombosis/resolution. DVT resolution is dependent on a number of factors. The primary natural driver of venous thrombosis is the urokinase plasminogen activator (uPA)-plasmin system. The plasmin axis is involved in local modulation of venous thrombosis and enrolls mostly uPA, driving DVT resolution, and tissue plasminogen activator (tPA). A cellular factor is also important and involves activation of leucocytes (neutrophils and monocytes).
The matrix metallo-proteases MMP-2 and MMP-9 play an important role in midterm DVT resolution. Thrombus neovascularization occurs with time, and is cellular driven from the periphery inward. The modulation of the neovascularization is via local hypoxia: a low level of 02 drives HIF-1a and secondarily neovascularization. Thrombus fibrosis contraction also occurs, but the mechanism is unknown. The use of normal iron metabolism for determining thrombus age and lysability potential could be useful.
Anthony Comerota, USA
The author focused on several areas including deep venous thrombosis (DVT) ultrasound resolution frequency and speed, differences between patient groups and between iliofemoral, femoro-popliteal, and calf DVT, characteristic changes in thrombus echogenicity, resolution vs valve fuction, and recurrent venous thrombembolism. Interesting data about prognosis of ultrasound normalisation (luminal obstruction less than 40% of a noncompressed vein) were presented. Postoperative DVT has a better prognosis than idiopathic DVT, and cancer-free outpatients have a better prognosis than cancer patients. Single-segment DVT also has a better prognosis than multisegment DVT. In a study by Baut, the left leg had a greater thrombus burden, but resolution rates were similar in left and right legs, and iliac veins had significantly less thrombus regression. According to this study, ultrasound characteristics cannot be used to age a thrombus (after 30 days in 70% of cases because of unchanged echogenicity). Slow clot resolution with persistent venous luminal abnormalities is associated with a high risk of recurrence.
Niels Baekgaard, Denmark
In the last two decades, the principle of catheter-directed thrombolysis (CDT) has become an alternative treatment modality for some types of deep venous thrombosis (DVT). Dealing with iliofemoral DVT is important because the iliofemoral segment is the outflow tract, responsible for the run-off from the entire leg, and this segment has the poorest chance for recanalization with anticoagulation alone. For the author, this issue is much more important than only « thinking of valves ». CDT treatment is limited to the thrombus alone, thereby minimizing the effect of a systemic anticoagulation treatment, and it permits placement of stents to abolish the obstructive lesions in the iliac vein during the procedure. The method should be applied for acute episodes of iliofemoral DVT with a thrombus not older than 14 days. Treatment with recombinant tissue plasminogen activator (tPA) for a few days is commonly used, and no deaths have been reported in 10 years of follow-up. The CDT is introduced through the popliteal vein and allows precise manipulation. The goal of treatment is to obtain patent veins with functional valves leading to a decreased occurrence of postthrombotic syndrome (PTS). Several randomized controlled trials comparing CDT and anticoagulation have reported good results,1 but with a short follow-up. In the Copenhagen study, there was a patency of 82% without reflux at 6 years, and the PTS rate was 16% with good quality of life. Only two major cases of bleeding occurred, with no deaths. In conclusion, CDT is a simple and safe technique that requires only a few days of treatment, and which has been proven to reduce the rate of PTS. Unfortunately, in a recent study only 15% of patients eligible for CDT were referred for treatment.
Reference
1. Enden T, Haig Y, Kløw NE, et al. Long-term outcome after additional catheterdirected thrombolysis versus standard treatment for acute iliofemoral deep vein thrombosis (the CAVENT study): a randomised controlled trial. Lancet. 2012;379:31-38.
Suresh Vedantham, USA
Several methods are available for thrombus removal:
• Infusion only for a mean duration of 53.4 hours through a catheter-directed thrombolysis (CDT).
• Infusion-first pharmacomechanical catheter-directed thrombolysis (PCDT) (refers to the combination of CDT with percutaneous mechanical thrombectomy): the infusion time and the drug doses are reduced by 40% and 50%, respectively, compared with CDT, with greater efficacy.
• Fast PCDT: Treillis and Angiojet can be performed in one session and are better for acute upper extremity deep venous thrombosis (DVT) and acute lower extremity DVT with a good inflow. The procedure usually takes 1-3 hours.
The PCDT technique enables faster clot removal, but some important questions remain: is 50%-75% clot removal sufficient to obtain good long-term results? What about thrombosed nonaxial veins? Does use of the device increase recurrent DVT? More long-term randomized controlled trials are required.
Antony Comerota,USA
The goal of early thrombus removal is to decrease the rate of postthrombotic syndrome (PTS), to improve quality of life, and to decrease recurrent deep venous thrombosis (DVT). The most powerful predictor of PTS is iliofemoral DVT. By removing the clot, one can improve outcomes. It has been proven that PTS does not occur if the residual thrombus after treatment is less than 10%. PTS is directly associated with the patency of the iliofemoral segment.
Suman Rathbun, USA
The most important factor when assessing risk of recurrent venous thromboembolism (VTE) is the relationship of the initial episode of thrombosis to risk factors. When a major reversible risk factor such as surgery can be identified as the sole explanation for VTE, then the risk of recurrence is relatively low (3% in the first year). In contrast, the risk is high (10% in the first year) in patients with unprovoked (“idiopathic”) VTE, and in those with persistent, irreversible, or other risk factors. Diagnostic testing is required because two-thirds of patients with a clinical suspicion of recurrent deep venous thrombosis (DVT) are subsequently shown to be free of acute thrombosis. All of the available diagnostic tests for DVT have limitations for excluding acute recurrent DVT: the results of compression ultrasonography may be persistently abnormal for 1 year in 50% of patients and longer in others, venography also has limitations for excluding the diagnosis of recurrent DVT due to obliteration and recanalization of the previously affected venous segment or nonfilled venous segments. Measurement of plasma D-dimer seems to provide a simple method for excluding acute recurrent DVT in symptomatic patients.1 The DASH score (D-dimer, age, gender, hormonal therapy),2 has been proposed as a method to assess the risk of recurrence, but is still in evaluation. Long-term anticoagulant treatment is highly effective in preventing recurrent VTE, but the optimal duration of this therapy remains uncertain. The next step is to identify patients at low risk who may benefit from a short period of anticoagulation for recurrent thrombotic events in order to drive a management strategy for both the prevention of recurrences and the selection of a DVT: DACUS study,3 AESOPUS study.4
References
1. Rathbun SW, Whitsett TL, Raskob GE. Negative D-Dimer result to exclude recurrent deep venous thrombosis: a management trial. Ann Intern Med. 2004;141:839–845.
2. Tosetto A. Predicting disease recurrence in patients with previous unprovoked venous thromboembolism: a proposed prediction score (DASH). J Thromb Haemost. 2012;10:1019-1025.
3. Siragusa S, Malato A, Anastasio R. et al. Residual vein thrombosis to establish duration of anticoagulation after a first episode of deep vein thrombosis: the “DACUS” study. Blood. 2008;112:511-515.
4. Prandoni P. Residual thrombosis on ultrasonography to guide the duration of anticoagulation in patients with deep venous thrombosis: a randomized trial. Ann Intern Med. 2009;150:577-585.
Suresh Vedantham, USA
The ATTRACT trial addresses a major controversy among physicians regarding the best way of treating patients with proximal deep venous thrombosis (DVT). On the one hand, even when standard blood-thinning drugs are used, 25%-50% of DVT patients will develop post-thrombotic syndrome (PTS), a long-term condition that causes daily pain, heaviness, fatigue, and swelling of the leg. Small studies of thrombectomy, systemic thrombolysis, or catheter-directed thrombolysis suggest that early clot removal may prevent PTS. As new catheter-based devices appear to offer safer clot removal, many doctors are now using clot-busting treatment for DVT more often. However, the American College of Chest Physicians (ACCP) have long advised against the routine use of clot-busting treatment, citing safety concerns (mainly the risk of bleeding with use of the clot-busting drugs), and the lack of strong evidence in favor of these more aggressive treatments from large, well-designed clinical trials. The delivery of state-of-the-art clot-busting drugs into the clot through a specially designed device such as Treillis or Angiojet (known as pharmacomechanical catheter-directed thrombolysis or PCDT), the potential risks and costs of PCDT, and the lack of physician consensus on the treatment of proximal DVT provide a compelling scientific and ethical rationale for a welldesigned clinical trial to determine if PCDT prevents PTS.
The ATTRACT study is a multicenter, randomized, controlled clinical trial of 692 patients with symptomatic proximal DVT that involves the iliac, common femoral, and/or femoral vein. Patients are randomized to receive anticoagulation and compression, catheter-directed thrombolysis (CDT), or PCDT followed by anticoagulation and compression. The duration of follow-up is 2 years. The study will answer five questions: Does PCDT prevent PTS? Does it improve quality of life? Is it safe enough? Is it cost-effective? And what is the mechanism by which PCDT prevents PTS? The results of this study are eagerly awaited, and if positive, could fundamentally change clinical DVT practice and improve health by enabling prevention of PTS, a common, morbid, and expensive condition, in thousands of patients.
Kathleen Gibson, USA; Russell Hull, Canada; Stephanie Dentoni, USA
Three presentations summarized current data about the range of new oral anticoagulants (NOACs). K. Gibson talked about the advantages and disadvantages of dabigatran. R. Hull reviewed the current situation with rivaroxaban, apixaban, and edoxaban, and S. Dentoni discussed the indications on the basis of published randomized controlled trials. The main conclusion by all the presenters was that NOACs are easy to use and noninferior in comparison with low molecular weight heparins and warfarin. However, NOACs do not have antidotes and this is their greatest disadvantage.
Thomas Wakefield, USA
What to do if a patient bleeds while on NOAC therapy? There are some available data concerning reversal agents for NOACs. For apixaban and rivaroxaban, fourfactor prothrombin concentrate complex (PCC) and activated PCC can be used; for dabigatran, activated PCC, hemodialysis and recombinant factor VIIa can be used. In the future, targeted agents such as PRT4445, which is similar to native factor Xa may be developed. The approach for reversal of NOACs should be determined by the patient’s clinical status. In the case of non-urgent reversal, the anticoagulant therapy can simply be withheld for 2-4 days. In the setting of major bleeding, withholding therapy is not sufficient and the above mentioned measures should be taken.
Susan Kahn, CanadaIn postthrombotic syndrome (PTS), subtherapeutic anticoagulation could result in suboptimal clot dissolution, leading to valvular damage and persistent venous obstruction. The results from the REVERSE study have shown that if a patient on warfarin has an International Normalization Ratio (INR) < 2 for more than 20% of the time the risk of PTS is significantly increased: OR 1.88 (95% CI 1.15-3.07) at 5-7 months. Take-home messages: new oral anticoagulants are noninferior in comparison to low molecular weight heparins and warfarin. Effective reversal agents for NOACs are still to be found. Suboptimal anticoagulation leads to PTS.
John Fletcher, Australia
The author focused on recent intensive activity in the development of new anticoagulants, which have demonstrated therapeutic benefit compared with low molecular weight heparin (LMWH) and warfarin. Four new oral anticoagulants (OA) are widely used – dabigatran, rivaroxaban, apixaban, and edoxaban. A simplified dosing regimen, no dietary restrictions, predictable anticoagulation, and no need for routine coagulation monitoring are their main advantages. Dr Fletcher described their dose, route of administration, possible interactions, and relation to surgery or, invasive interventions. OA should be stopped at least 24 hours before surgery, if possible. The time of treatment cessation should be based on benefit/risk, and should be earlier, for example in patients with a higher risk of bleeding or in cases of major surgery where complete hemostasis is required. Until now, we have had no specific agent to reverse the anticoagulant, and if the procedure cannot be delayed, the increased risk of bleeding should be assessed against the urgency of intervention. Dr Fletcher concluded that OAs represent a viable alternative for patients who have poor warfarin control or cannot be treated with warfarin. Studies show that patients well controlled on warfarin are less likely to benefit from switching to an OA.
guidelines on the prevention of venous thromboembolism?
Joseph Caprini, USA
Individual risk assessment is an important tool to evaluate patient thrombosis risk, particularly prior to an intervention. The Caprini thrombosis risk scoring assigns a point value to each risk factor according to the relative risk of venous thromboembolism (VTE) based on the literature and validation studies. It balances the risks and benefits of anticoagulation according to the relative probability of bleeding versus thrombosis, and accounts for all risk factors that could affect the outcome of a procedure or illness. A linear relationship exists between the score and the incidence of clinically relevant VTE. In a study of 2016 patients, those with a score of >8 suffered a >18.3% incidence of clinical VTE and were more likely to develop a VTE compared with patients with a Caprini risk score of <8 (P<0.001).
The Caprini score can be used to identify low-risk patients that may be spared the risks of anticoagulation, and also to identify those with high and very high risk, where extended prophylaxis should be considered.
Russell Hull, Canada
Elective hip replacement: Low molecular weight heparin (LMWH), fondaparinux, vitamin K antagonists (VKAs), rivaroxaban, apixaban, dabigatran are recommended (level of evidence (LE): high)
Elective knee replacement: LMWH, fondaparinux, VKAs, rivaroxaban, apixaban, dabigatran are recommended (LE: high). Intermittent pneumatic compression (IPC) is an alternative option, and LMWH combined with IPC is more effective than LMWH prophylaxis alone and should be considered in all cases (LE: high).
Hip fracture surgery: LMWH, fondaparinux, adjusted dose VKA, low-dose unfractionated heparin (LDUH) (LE high).
Knee arthroscopy for simple diagnostic: a careful risk assessment should be undertaken. Routine prophylaxis is not recommended unless other risk factors are present (LE: low).
Knee arthroscopy for surgery: LMWH starting before or after the surgery (LE: moderate) or IPC in the presence of contraindications to LMWHs are recommended (LE: low).
Sam Goldhaber, USA
Pulmonary embolism (PE) is the first cause of preventable death among hospitalized patients, and survivors of venous thromboembolism (VTE) are at risk for recurrent deep venous thrombosis (DVT) or PE and postthrombotic syndrome (PTS).
In-hospital VTE prophylaxis halves the VTE rate without increasing major bleeding. After discharge, the VTE rate doubles and VTE-related death increases fivefold so there is also a need for prophylaxis in that situation. Those who will benefit the most from extended prophylaxis are female, elderly, and immobile patients. Among acute stroke patients with immobility, intermittent pneumatic compression reduced all DVT, symptomatic DVT, and overall mortality at 6 months.
The IUA 2013 VTE prophylaxis guidelines provide a roadmap for implementing « best clinical practice » among patients vulnerable to PE and DVT.
Bo Eklöf, Sweden
Despite appropriate anticoagulant therapy, about 50% of patients with deep venous thrombosis (DVT) will develop postthrombotic syndrome (PTS) sequelae, which can be severe in up to 20% of this population.
Although it is not possible to foresee the development and course of PTS in individual patients, clinical predictors of PTS are identifiable at the time of acute DVT. Proximal DVT involving the common femoral or iliac veins, elevated BMI, previous ipsilateral DVT, high Villalta score after 1 month, and older age are all associated with the development of PTS. Anticoagulation therapy alone will not protect against the occurrence of venous obstruction and valvular destruction, and initial insufficient anticoagulation treatment is associated with an increased risk of thrombus propagation, pulmonary embolism, and recurrent DVT. When elastic compression stockings are combined with early ambulation, the rate of PTS is decreased, but a lack of compliance will increase the risk. In a recent multicenter randomized controlled trial (SOX trial) of 800 patients, elastic compression stockings did not prevent the incidence of PTS after a first proximal DVT, and did not influence the severity of PTS or the rate of recurrent venous thromboembolism. Early thrombus removal, whatever the technique, has been shown to decrease rates of PTS, and stenting of remaining iliac vein obstruction seems to improve long-term patency. A chronic obstruction of the iliofemoral segment following an acute DVT is common as only 20%-30% of iliac vein thrombi recanalize with anticoagulation alone. Proximal obstruction is the principle cause of PTS in approximately 30% of cases. Percutaneous endovenous angioplasty and stenting is the treatment of choice. A recurrent ipsilateral DVT is probably the most important etiologic factor in the development of PTS. Reducing the rate of recurrent DVT will therefore decrease the incidence of PTS.
Jawed Fareed, USA
The new oral anticoagulants (NOAs) representing anti-IIa (dabigatran) and anti- Xa (rivaroxaban, apixaban) are effective in the management of postsurgical prophylaxis of deep venous thrombosis (DVT). Benefits claimed for these agents include ease of administration without the need for routine monitoring, and less drug and food interactions. However, they also have certain drawbacks including the lack of an antidote to neutralize bleeding.
Rivaroxaban is approved in Europe and the USA for the prophylaxis of DVT after orthopedic surgery, and for the treatment and prevention of recurrence of DVT/pulmonary embolism.
Apixaban and dabigatran are approved in Europe for postsurgical DVT prophylaxis, but not in the USA.
These agents should be used with caution in elderly patients, especially those with compromised renal or hepatic function or those prone to bleeding because of a greater risk of hemorrhagic complications. Due to the lack of an antidote, the management of bleeding episodes is difficult. Dabigatran is an absolute contraindication in patients with mechanical heart valves, and is not useful in pregnancy. Clinical trials also reveal that these agents are relatively inferior to the standard of care in medical patients, especially in cancer, and cost considerations present an additional factor limiting their widespread use. For DVT prophylaxis, heparins and warfarin will remain the standard of care. However, in compromised patients, NOAs may be an option. Warfarin’s low cost, efficacy and «track record » will prolong its life. In time its use may decrease, but it will remain a useful drug for years to come. Due to the risk of uncontrollable bleeding complications, NOAs are of no value for interventional and surgical indications.
Jawed Fareed, USA
Oscar Maleti, Italy
The author presented a new method to correct chronic venous insufficiency: the Italian neovalve. The purpose is to create an anti-reflux mechanism in patients with deep venous reflux when conservative treatments are not able to prevent dystrophic lesions (C4b-C6). Over the period January 2000 to May 2013, the author performed 602 procedures in the deep venous system: 352 open and 250 endovascular.
According to the author, the neovalve is indicated in patients classified as C3-C6 after failure of conservative treatments, and after previous treatment of the superficial system.
The author stated: “Equilibrium doesn’t mean restoring normal anatomy and physiology, but acting in a strategic and progressive way on hemodynamic lesions, so that one can obtain a re-equilibrium of the leg.”
The technique aims to create an anti-reflux mechanism in patients affected by deep venous reflux whenever valvuloplasty is not feasible. There are many options for reconstruction: bicuspid neovalve, monocuspid neovalve, monocuspid by parietal invagination, and enlargement of the flap to obtain a “sail effect.”
Kumudi Rai, India
According to the author, deep venous thrombosis (DVT) accounts for almost 10% of cases of chronic venous insufficiency. A retrospective study reviewed patients affected by chronic venous insufficiency following DVT who were managed with surgery or endovascular procedures during the period January 2010 to December 2012. Clinical assessment included history of venous claudication, physical examination, duplex scan, and computed tomography (CT) venography. The outcome was based on technical success and relief of symptoms.
Forty-five procedures were performed (31 endovascular, 14 superficial femoral and popliteal veins). The author had technical success in 28 cases of endovascular procedures in iliac territory (93.5%), and in 13 surgical cases (92.8%). The follow-up was between 3-38 months (median 14 months) by clinical examination, duplex scan and CT venography.
The author concluded that endovascular and surgical management of chronic occlusive disease gives reasonably good results in selected cases.
Paul Timperman, USA
The author stated that it had not yet been proved that the safety and efficacy of retrievable filters was equivalent to that of permanent filters.
A minority of filters must be removed, and the removal is associated with many serious complications.
Trauma is the commonest indication for temporary filters.
Inferior vena cava (IVC) filters are indicated when primary therapy cannot be started or when the patient has recurrent pulmonary embolism despite adequate anticoagulant therapy.
Cees Wittens, The Netherlands
With the rising popularity of venous stenting, and the consequent increasing experience in these techniques, an increase in treatment complications is inevitable. The author discussed the potential complications and gave advice on how to prevent unnecessary mistakes. The most common complication is early occlusion (30 days) due to local thrombosis, and perioperative thrombosis prophylaxis is therefore critical. Recanalization and stenting procedures are usually performed under full anticoagulation therapy. Following intervention, the author’s group usually places patients on therapeutic low-molecular-weight heparin until a therapeutic international normalized ratio (INR) level (3.0–4.0) is reached with coumadin, which is then continued for at least 6 months. When no underlying coagulation disorders are present, these standard anticoagulation protocols have good results in preventing venous thrombosis. In contrast, platelet inhibitors like aspirin and clopidogrel appear less effective in preventing venous thrombosis1. Unfortunately, even though they are rare (3%), major hemorrhagic complications can occur. The author has had no cases of perioperative death or pulmonary emboli due to recanalization attempts and subsequent stenting. Minor complications like hemorrhage at the access site (6%) or prolonged pain are more frequent, but are easily managed in the majority of cases. In regard to stenting in this specific location, there are several issues that can arise. Patency can be impaired by: an incorrect inflow (at femoral vein level), a stent-related problem (fracture, kinking, non-alignment and tapering), or an inadequate outflow (at inferior vena cava level, much less common). Incorrect inflow can frequently be corrected by femoral endophlebectomy, stenting to this level, and an AV-fistula construction. The frequency of stent-related issues seems to depend on the stent design. In contrast with the arterial-designed stents initially used, more recent, vein-dedicated stents appear to have a higher flexibility and radial force, possibly leading to reduced stent-related problems, and thus permitting a better primary patency and a reduction in the number of reinterventions.
Reference
1. Paikin JS, Wright DS, Eikelboom JW. Blood Rev. 2011;25:123-129.
Peter Neglén, Cyprus
The perfect stent has not yet been designed because the theoretical characteristics of the stent that the clinician desires are difficult to match with the physical characteristics of the material.
An ideal stent would: be easy to place and replace, create an adequate flow channel, restore flow channel adequately, have long patency, be nonantigenic, have structural integration, resistance to kinking, prevent recurrent thrombosis, and be self-expansile while allowing repeated shortening and twisting.
Several of these characteristics (eg, radial force vs strength) are opposing, and if one is improved, the suitability of the other decreases. Most stents of modern design are not intended for use in the USA.
David Gillespie, USA
There are several “tricks” for crossing the iliac obstruction, and success can be achieved in most cases with:
1. Appropriate patient selection.
2. Multimodality image assessment (simple venography, multiplan venography, 3D computed tomography venography, duplex or intravascular ultrasound [IVUS]). The more information you can obtain, the greater the success rate. Multiplane venography is more useful for visualizing and assessing a stenotic lesion than any other method. IVUS is the most accurate tool for assessing iliac vein pathology.
3. Critical evaluation of inflow and outflow.
4. Appropriate stent sizing.
5. Thoughtful treatment of bifurcation lesions. 6. Aggressive and continuous monitoring of the patient postoperatively.
Antonios Gasparis,USA
Isolated bilateral iliac involvement is rare and in the majority of cases there is also involvement of the inferior vena cava.
Double femoral access is required and the right jugular vein approach may be necessary in some cases. Lesion crossing can be achieved with a 0.35 inch guide-wire with a 4F guide-catheter. In some cases, 0.18 and 0.14 crossing wires may be necessary. Oblique views should be used if there is any uncertainty about where the wire is going. If unable to cross… try another day. Once crossed, dilate to create a channel using a high-pressure balloon prior to placing the stent. In cases of multiple stent placement, overlapping is necessary.
Peter Neglen, USA
Stenting in the venous system is different to arterial stent placing for several reasons: (a) no kissing balloon is necessary to protect the contralateral side in venous confluences; (b) the different structure of the wall lesions in diseased arteries and veins (diffuse fibrosis in veins in contrast to layered plaque in arteries); and (c) diseased veins are stiffer and thus the angioplasty balloons must be able to inflate at high pressure.
Stenting venous iliofemoral stenotic lesions must be performed in a radiological suite with technical accuracy (infusion pumps, subtraction angiography), and under anesthesia in order to achieve long-lasting results.
Venous access is usually ipsilateral, but this approach may not be possible if the femoral vein is not patent. In such cases, popliteal (via selective canalization of branch communication with profunda) access can be achieved. However, the femoral contralateral approach is not possible with the patient in the prone position. Contralateral access navigation and stent deployment is more difficult. Femoral access is preferred by surgeons, but the internal right jugular access is preferred by some radiologists in certain circumstances.
1. Ultrasound-guided tight access The puncture of the vein must be clean. Echo-guided puncture is desirable, as ultrasound can provide information on the vein, and help locate the vein as well as the needle. Sheath size is not important, veins have less tendency to hemorrhagic and thrombotic complications due to sheath size. Systemic complete anticoagulation (5000 IU heparin) is performed after vein canulation. The recanalization is made over 0.35 inch guidewires. It is sometimes necessary to change to stiffer wires if there is no support.
2. The use of intravascular ultrasound (IVUS) is essential. The procedure begins with phlebography, and crossing the lesion with a guidewire. Non-occlusive lesions and short occlusions are easy to cross, but true occlusions need recanalization with guiding catheters, guidewires, and quick-cross catheters. If the guidewire does not progress and reaches an extraluminal situation, the risk of bleeding is minimal, but this false lumen is likely to be followed by the guidewire in any subsequent attempts. It is therefore better to try again several days later. If recanalization is successful, one can ensure that the true lumen location has been reached using IVUS.
3. Identify degree and extent of the lesion. No hemodynamic tools are available. It is accepted that more than 50% stenosis is a reason to treat. Remember that the lesion must be visualized in different projections. Positive pressure measurements support the presence of significant obstruction, but normal pressures do not exclude it. Use large sheaths and high pressure balloons to pre-dilate the lesion; stiff guidewires may be necessary.
4. Always stent, balloon dilation alone results in recoil in most of the lesions. Use 14 or 20 mm stents, 6-20 mm length, flexible, and with radial force; wall rupture is not a major concern. Re-dilate the stent to ensure wall apposition. Stent all lesions without skipping any areas. Overlap stents generously to avoid separation (at least 2 cm). Ensure outflow and inflow by adequate stent extension.
5. Stent the inferior vena cava through occluded filters.
Ahmad Alomari, USA
Advances in the treatment of venous malformations (VMs) are still limited, despite progress in our understanding of its clinical and genetic aspects. VMs typically manifest as solitary blood-filled spongiform lesions that can be disfiguring in some cases, leading to poor quality of life. Pain may be caused by thrombosis, engorgement or involvement of joints. Different types of venous malformations such as phlebectasia, venous aneurysms, Bean syndrome, glomovenous malformations, and Klippel Trenaunay syndrome demand a specific treatment for each case.
High-resolution ultrasound and magnetic resonance imaging are the most helpful imaging modalities. Treatment indications and the management of patient expectations must be conducted with great clarity by the doctor in the first consultation based on patient history, a clinical assessment, and review of imaging status. It should be noted that none of the available treatments offer a cure for VMs.
Minimally-invasive approaches to VMs include sclerotherapy, laser, and photodynamic therapy, embolization of anomalous phlebectasia, and combinations of treatments.
Ultrasound guidance and angiography under anesthesia are used when treating VMs with sclerotherapy. The double needle technique is commonly used by the author. Sclerotherapy outflow control is not needed for most cases nor is a tourniquet for long periods of direct compression. In some cases, the author suggests the initial use of foam to block the flow, in combination with ethanol (0.5-1.0 mg kg, max 30-60 cc).
Extravasation is the most common cause of complications. Signs of extravasation are a geometric smooth or lenticular contrast collection around the needle tip. The author recommends follow-up at 1 day, 1 week, and 1 month, and an office visit at 2 months with photos.
Melvin Rosenblatt, USA
According to the author, the prevalence of symptomatic pelvic venous disorders is poorly studied in the literature. About 33% of the female and multiparous population will suffer from symptomatic pelvic venous disorders. In the USA, 15%-20% of women aged between 18 and 50 years complain of chronic pelvic pain, costing society about $3.3 billion/year.
The author reports that 10% of lower limb varicose veins and 34% of nonsaphenous reflux are of pelvic origin. Pelvic or supra pelvic reflux are detected by duplex scan in 16.6% of patients with postoperative recurrences of varicose veins.
Patients with pelvic venous pathology often have confusing presentations and complex venous anatomy. Lower extremity ultrasound may only hint at the diagnosis. Patients with pelvic disorders can present with pelvic as well as lower extremity symptoms.
The pelvic symptom is pain during standing, after intercourse, and with menstruation. The lower extremity symptoms are: vulvar varicosities, generalized heaviness and achiness, varicosities, and swelling.
The sources of the varicosities are: gonadal vein insufficiency, internal iliac venous insufficiency, congenital vascular anomalies, and internal iliac hypertension (nutcracker syndrome, May-Turner syndrome, and inferior vena cava obstruction).
The initial treatment decision is symptom driven:
If symptoms are confined to the pelvis then focus treatment on superior reflux component.
If symptoms primarily involve the lower extremity, then focus treatment on the lower reflux components.
The secondary treatment decision is driven by two factors:
Recurrence of varicosities.
Persistent symptoms.
The images used for diagnosis are: ultrasound, computed tomographic venography, magnetic resonance venography, and venography.
The treatment of the inferior component when varicosities are extensive is made with sclerotherapy, which can be used just as when treating the internal iliac vein reflux. It is important to reach the periuterine venous plexus.
The author recommends treatment of the superior component by approaching the jugular vein with cava and left renal injection, making a selective venogram from the gonadal veins. The use of coils plus sclerotherapy is recommended by the author to treat the gonadal vein reflux. An occlusion balloon can be used to trap the embolic in the pelvic varicosities.
The author reports initial success in 98%-100% of upper components treated; successful pelvic symptom resolution ranges from 50%-80% in published series. The author reports success in 57 patients with lower components: 80% required one treatment and 18% required an average of 1.5 sclerotherapy treatments; 2% of treatments required a second embolization.
In conclusion, pelvic-derived varicosities have many etiologies, but good abdominal ultrasound may often be enough to make the correct diagnosis. Management strategies are dependent on the patient’s clinical presentation, not on the presence of disease. Minimally invasive treatment strategies for reflux disease may be very effective.
Further reading:
Jung SC, Lee W, Chung JW, et al. Unusual causes of varicose veins in the lower extremities: CT venographic and Doppler US findings. Radiographics. 2009;29:525- 536.
Hobbs JT. Varicose veins arising from the pelvis due to ovarian vein incompetence. Int J clin Pract. 2005;59:1195-1203.
Jiang P, van Rij AM, Christie RA, Hill GB, Thomson IA. Non-saphenofemoral venous reflux in the groin in patients with varicose veins. Eur J Vasc Endovasc Surg. 2001;21:550-557.
Paul Thibault, Australia
This presentation focused on the etiology of multiple sclerosis. Epidemiological and geographical findings for the prevalence of this disease indicate the involvement of an infective agent. A number of agents have been suggested, but the respiratory pathogen Chlamydia pneumoniae has the most convincing evidence from a spectrum of medical disciplines. It is proposed that the pathogenesis of multiple sclerosis is initiated by this bacteria, which causes a specific chronic persistent venulitis affecting the cerebrospinal venous system. The theory proposes a mechanism by which an infective phlebitis could result in the specific neural damage, metabolic, immunological, and venous obstructions observed in multiple sclerosis. This approach provides a framework for further research and opens a pathway for alternative therapies.
Pro: Paolo Zamboni, Italy
Con: Alun Davies, UK
The aim of this debate was to analyse the actual scientific evidence on chronic cerebrospinal venous insufficiency (CCSVI) and its association with multiple sclerosis (MS).
PRO: Paolo Zamboni: examined all published studies on the prevalence of CCSVI in MS patients, including ultrasound and catheter venography series, and the press release of the recent COSMO study.
According to Paolo Zamboni, the bibliography shows intraluminal obstruction in 72% of MS patients versus 17% of controls. Abnormal fibrosis and microdepositions and calcifications in the vein wall were observed by synchrotron-based XRF imaging. Evidence already exists for a reduced perfusion in MS, but there has been no attempt to correlate this with obstructed venous outflow. 2D MRI flow techniques demonstrate that flow in the internal jugular veins in humans is linearly related to global brain perfusion.
CON: Alun Davies: referred to the absence of scientific data according to the Bradford Criteria (strength of association, consistency, specificity, temporal relationship, biological gradient, plausibility, coherence, and reversibility).
Ultrasound alone is not a reliable tool to define CCSVI. Alun Davies believes multimodal imaging, venography and intravascular ultrasound are required to move forward in terms of diagnostics.
