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Ann Thorac Surg 2003;75:1693-1696
© 2003 The Society of Thoracic Surgeons

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Original article: general thoracic

Paget-Schroetter syndrome therapy: failure of intravenous stents

^a Department of Cardiothoracic Surgery, Baylor University Medical Center, Dallas, Texas, USA

^* Address reprint requests to Dr Urschel, Baylor University Medical Center, 3600 Gaston Ave, Suite 1201, Dallas, TX 75246, USA
e-mail: drurschel{at}earthlink.net

Presented at the Forty-ninth Annual Meeting of the Southern Thoracic Surgical Association, Miami Beach, FL, Nov 7–9, 2002.

	Abstract

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BACKGROUND: The purpose of this study is to show that intravenous stents (IS) are contraindicated in patients with thrombosis of the axillary-subclavian vein (Paget-Schroetter syndrome).

METHODS: Twenty-two patients had IS placed after balloon dilatation of the venous compression in the thoracic outlet. Each of the patients receiving IS had the diagnosis made less than 6 weeks after vein occlusion, previous thrombolytic therapy, and poststent anticoagulants. (All were performed in outside hospitals. In no case was surgical decompression of the "externally constricted venous tunnel" performed.) The 22 patients receiving IS were compared with a similar group of 384 patients seen less than 6 weeks after thrombosis who were treated with "optimal therapy," ie, thrombolysis and prompt transaxillary resection of the first rib with venous tunnel decompression.

RESULTS: All 22 patients with IS reoccluded their axillary-subclavian vein from 1 day to 6 weeks after insertion. All were retreated with thrombolytic therapy and first rib resection. Ten remained patent and 7 remained occluded but developed adequate collateral circulation. All 17 were asymptomatic. Five remained occluded with minimal collateral circulation. Attempts were made to reopen them a third time. All 5 are receiving long-term anticoagulants. In contrast the 384 patients managed with optimal therapy were significantly improved without retreatment or anticoagulants.

CONCLUSIONS: From our study, there is no indication for use of IS in patients with Paget-Schroetter syndrome; in fact, from our experience it is contraindicated when compared with the optimal therapy group. Other authors corroborate this conclusion in recent review articles.

	Introduction

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Paget-Schroetter syndrome (PSS), or "effort" thrombosis of the axillary-subclavian vein, usually occurs in patients secondary to excessive arm activity in the presence of one or more compressive elements in the thoracic outlet. The axillary subclavian vein traverses the tunnel formed by the clavicle and subclavius muscle anteriorly, the scalenus anticus muscle laterally, the first rib posterior-inferiorly, and the costoclavicular ligament medially. Abnormalities of any of these structures, whether congenital, traumatic, or distorted by unusual exercise or physical stress, may narrow the tunnel anatomically. The most common defect is the congenital insertion of the costoclavicular ligament far laterally on the first rib.

With the external anatomic constriction, on which may be superimposed dehydration, thrombogenicity, excessive exercise, or unusual activity, such a patient has an increased chance for vein thrombosis.

Previously, conservative management of PSS included elevation of the arm and anticoagulants [1, 2]. If symptoms recurred, the patient was considered for first rib resection with or without thrombectomy. For the last 20 years the "optimal" management has been early recognition and thrombolysis of the occluded axillary-subclavian vein, followed by immediate transaxillary first rib extirpation and neurovascular decompression. Thrombolytic therapy, combined with prompt surgical neurovascular decompression of the thoracic outlet, has also been shown to reduce morbidity and necessity for thrombectomy [3, 4].

However, with the advent of stenting blood vessels, there has been an increased rate of venous stent placement for PSS. The use of stents in both the peripheral and central arterial systems has been shown to be successful [5]. However, similar results have not been demonstrated in stenting the venous system [6–9]. This finding may be related to low flow or decreased pressures in the venous system.

The purpose of this report is to evaluate the role of peripheral venous stenting in the management of patients with PSS and compare the stented group with a similar optimal therapy group of 384 PSS patients also treated less than 6 weeks from initial thrombosis.

	Material and methods

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Patients
Twenty-two patients with PSS diagnosis, less than 6 weeks from initial thrombosis, received thrombolytics, venous balloon angioplasty, and intravenous stent placement. These were seen during a period of 8 years. There were 12 men and 10 women ranging in age from 17 to 42 years (mean, 29 years). All patients had stents placed in outside hospitals. There was no standardized indication for stent implantation, because the patients were referred from a number of different physicians and hospitals from around the world. All patients with stents were seen initially less than 6 weeks after initial thrombosis. A variety of intravascular stents were inserted. All patients were referred from outside medical centers after early failure of the venous stent (mean, 14 days; range, 1 day to 6 weeks).

The 22 stent patients were retreated similar to 384 patients evaluated and operated on less than 6 weeks from initial vein occlusion. These 384 patients are termed the optimal therapy group. The 22 stent patients and the optimal therapy group of 384 PSS patients were anticoagulated with heparin and underwent venography through a distal indwelling venous catheter, followed by thrombolytic therapy. This was initially performed with urokinase (loading dose, 4,400 U/kg bolus and 4,400 U/h until clot lyses) After the withdrawal of urokinase by the U.S. Food and Drug Administration, tissue plasminogen activator (Genentech, San Francisco, CA) was used for thrombolysis with the following protocol: 2 mg/h for 8 hours and then 1 mg/h until the clot dissolved [10–12]. Assessment of the therapeutic effect included frequent clinical observation as well as serial venograms through the indwelling catheter. Most patients showed major improvement in less than 24 hours after the initial administration of the thrombolytic agent. Mean time for clot lysis was 20 hours (range, 4 to 38 hours).

Operative technique
After heparin and thrombolytic therapy were stopped, the first rib was promptly removed through a transaxillary incision^. In addition, complete division of the costoclavicular ligament, the scalenus anticus muscle, and any bands or adhesions was performed. Scalenectomy was completed to minimize the possibility of muscle fibers reattaching to Sibson’s fascia. Any congenital or compressive bands were removed from the axillary subclavian vein. Usually direct observation was adequate to assess patency of the vein. This operative technique was previously described [13–16].

Through the transaxillary approach, the vein is one of the critical landmarks for the dissection of the first rib because of its blue color. In patients with PSS, the vein is occluded and often markedly thickened. The blue color is absent. The vein is the same color as the other structures, such as the artery, muscle, and so forth. Because of this, many surgeons who do not routinely perform this operation may have difficulty locating the anatomic structures.

In addition, for most patients operated on less than 6 weeks after thrombosis, there is a severe inflammatory reaction around the neurovascular structures and first rib. These structures may be "plastered down" to the first rib making the dissection hazardous. Several cases that had previous breast implants inserted through the axilla were included in this group of patients. Because of this, structures such as the vein, artery, and brachial plexus may be intimately adherent to the first rib, significantly increasing symptoms and also increasing the risk of the operative procedure. This should be suspected in such situations and extra care should be taken not to injure any of the neurovascular structures. Extremely long surgeries (up to 8 hours) have been reported by surgeons who cannot seem to find the vein when it is totally occluded. This increases the incidence of nerve injuries [4].

	Results

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All 22 of the stent patients had thrombosis of the venous stents within 6 weeks of placement and were referred to our hospital. The 22 patients were retreated with the rethrombolysis protocol followed promptly by surgical decompression of the vein. Ten extremities were reopened and 12 remained occluded. Mean follow-up of 3.5 years (range, 1 to 8 years) showed 10 patients had patent veins. Of the other 12 patients with occluded veins, 7 developed good collateral circulation and were asymptomatic. Five had no collaterals, were symptomatic, and required attempted venous thrombectomy with an atherectomy catheter (two of five opened) in addition to long-term anticoagulation. Venous bypass grafts are not effective [3]. There was no mortality in any group and no observed evidence of pulmonary embolism.

In the comparison group of 384 PSS patients evaluated after at least 6 months, who had been treated less than 6 weeks from original thrombosis (optimal treatment) 380 of 384 patients were opened initially with thrombolytic agents and 4 recanalized late (10 days to 6 months). Follow-up was a mean of 7 years (range, 1 to 20 years) and showed 380 with a good result (symptoms relieved and returned work) and 4 with a fair result in that the symptoms were relieved but they could not return to heavy-repetition work. None of these patients required retreatment or anticoagulants.

	Comment

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Historically, Sir James Paget [17] in 1875 in London and Von-Schroetter [18] in 1884 in Vienna described this syndrome of thrombosis of the axillary-subclavian vein, which bears their names. The word "effort" [19] was added to thrombosis because of the frequent association with exertion superimposed on anatomic compressive elements in the thoracic outlet. Trauma, unusual occupations requiring repetitive muscular activity, as has been observed in professional athletes, linotype operators, painters, and beauticians, and cold temperatures tend to increase the susceptibility to thrombosis [20–23]. Elements of increased thrombogenicity also exacerbate the incidence of this problem.

De Weese and colleagues [1] reported long-term results in patients treated conservatively with elevation and Coumadin. There was a 12% incidence of pulmonary embolism, which was not observed in any of our patients. Development of occasional venous distention occurred in 18%, and late residual arm symptoms of swelling, pain, and superficial thrombophlebitis were noted in 68% of the patients (deep venous thrombosis with postphlebitic syndrome). Phlegmasia cerulea dolens was present in 1 patient.

These findings substantiate our observations that a more aggressive operative approach after thrombolytic therapy is indicated. This is particularly true for younger patients with precipitating factors [3, 4, 24].

The natural history of PSS suggests moderate morbidity [1, 4, 25] with conservative treatment alone. Bypass with vein or other conduits [26–28] has limited application in our experience. Causes other than thoracic outlet syndrome must be treated individually using the basic principles mentioned. Intermittent obstruction of the subclavian vein [29] can lead to thrombosis, and decompression should be used prophylactically.

Clinical manifestations of PSS were present in 512 patients requiring operation; the methods of diagnosis and treatment of these patients were previously separated [4]. It is obvious that the earlier that a patient with PSS (effort thrombosis) can be diagnosed by the physician and treated with thrombolytic agents followed by prompt first rib resection, the better the results. The longer the time interval between the acute thrombolytic episode and therapeutic intervention, the less effective the therapy. Efforts at thrombolysis, or "Roto-Rooter" techniques, are less effective after 3 months [4].

What is the result of stents for PSS? Only the failures were referred to us. Is it possible there are other good results from intravenous stents? Sharafuddin and Melhem [5] and Beygui and colleagues [8] have reported no value of stents for PSS. Kreienberg and coworkers [6] showed no value of stents except in the occasional short stricture after successful lysis and surgical decompression. We have never seen such a patient in the PSS group.

In our experience, there is little evidence that long-term Coumadin or heparin therapy has any benefit, either after therapy or for conservative treatment of patients who remain occluded. Low-dose nonanticoagulant levels of Coumadin have been reported to empirically recanalize long-term vein occlusions [4, 30]. Certainly, thrombogenic states such as dehydration should be avoided.

Dr Stent was a dentist in 19th century England, who developed plaster of Paris impressions of the mouth and teeth which were called stents [31–33].

In PSS, venous angioplasty and stents have no role in the treatment algorithm. In our experience, the use of percutaneous transluminal venous angioplasty plus intravenous stents ignores the external compressive factors in the thoracic outlet and has a high failure rate. Early venogram with thrombolytic agents to open the thrombosed axillary-subclavian vein is the preferred treatment. Prompt transaxillary first rib resection and neurovascular decompression, particularly in the area of the axillary subclavian venous canal, should be expedited. Anticoagulants do not appear to be helpful after this procedure.

	Discussion

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DR THOMAS S. MAXEY (Charlottesville, VA): Doctor Urschel’s series of patients with thoracic outlet syndrome and Paget-Schroetter syndrome is probably greater than the rest of the published literature combined. This paper and beautiful presentation clearly demonstrate the tremendous failure rate associated with peripheral venous stenting. We can all only hope that these important data reach far beyond the surgical literature.

I do, however, have a couple of questions. At the University of Virginia, we have a cohort of about 30 to 40 patients during the last decade that for one reason or another refused surgical decompression after successful venolysis. We have followed these patients closely on Coumadin therapy, and, for the most part, they have done reasonably well. Two have recurred after cessation of Coumadin, one at 11 months and the other was several years out. I was wondering if you had any experience with patients that for whatever reason did not get decompressed early or decompressed at all, and if so, what has been their outcome?

My second question is related to the 22 stented patients you have just presented. Obviously, these are only a small percentage of patients being stented and referred to you for failure. Can you speculate on outcomes of other stented patients that maybe you have not seen?

Thank you again for a timely and most relevant presentation.

DR URSCHEL: The 30 or 40 patients that did well remind us of our early series. Our optimal management therapy has evolved since 1960. The early group was treated by anticoagulants and went back to work, and they were only operated on if they returned to us with recurrent symptoms or could not do their job. Then we added streptokinase in the 1970s and then subsequently urokinase in the 1980s, tissue plasminogen activator more recently, and back to urokinase. But we believed if we get any kind of a clotting or difficulty the second time, that some of them are not going to develop collaterals, and we do not know which ones.

It is like the question, why do you take out the first rib when you take out a cervical rib, because a lot of people will do well. If we cut the scalenus anticus in somebody, a lot of people do well, but you do not know which one it is going to be. So therefore you do the operation that takes care of most of the people. It is like the belt and suspenders, and it requires an anatomic familiarity and comfortableness in that area.

Doctors Shaw and Paulson did a lot of superior sulcus tumors, which was where I received my introduction to this area. I feel very comfortable working in the brachial plexus. Susan MacKinnon is one of the best brachial plexus surgeons in the world, and she is very comfortable going through the supraclavicular approach. But when you have to retract nerves supraclavicularly to get down to anything below it, you are going to have a higher incidence of nerve injury than when you are looking up like that.

And, again, the 22 patients is a very small group of stents, but in the review article cited in our paper the authors reviewed something like 2,000 cases of stents placed in venous positions around the body, not all of them in the axillary subclavian vein, and none of them do well in this size vein with the low flow.

	References

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