CLINICAL RESEARCH STUDIES

From the American Venous Forum

Combination treatment of venous thoracic outlet syndrome: Open surgical decompression and intraoperative angioplasty
Darren B. Schneider, MD,ab Paul J. Dimuzio, MD,c Niels D. Martin, MD,c Roy L. Gordon, MD,b Mark W. Wilson, MD,b Jeanne M. Laberge, MD,b Robert K. Kerlan, MD,b Charles M. Eichler, MD,a and Louis M. Messina, MD,a San Francisco, Calif; and Philadelphia, Pa
Objective: Residual subclavian vein stenosis after thoracic outlet decompression in patients with venous thoracic outlet syndrome is often treated with postoperative percutaneous angioplasty (PTA). However, interval recurrent thrombosis before postoperative angioplasty is performed can be a vexing problem. Therefore we initiated a prospective trial at 2 referral institutions to evaluate the safety and efcacy of combined thoracic outlet decompression with intraoperative PTA performed in 1 stage. Methods: Over 3 years 25 consecutive patients (16 women, 9 men; median age, 30 years) underwent treatment for venous thoracic outlet syndrome with a standard protocol at 2 institutions. Twenty-one patients (84%) underwent preoperative thrombolysis to treat axillosubclavian vein thrombosis. First-rib resection was performed through combined supraclavicular and infraclavicular incisions. Intraoperative venography and subclavian vein PTA were performed through a percutaneous basilic vein approach. Postoperative anticoagulation therapy was not used routinely. Venous duplex ultrasound scanning was performed postoperatively and at 1, 6, and 12 months. Results: Intraoperative venography enabled identication of residual subclavian vein stenosis in 16 patients (64%), and all underwent intraoperative PTA with 100% technical success. Postoperative duplex scans documented subclavian vein patency in 23 patients (92%). Complications included subclavian vein recurrent thrombosis in 2 patients (8%), and both underwent percutaneous mechanical thrombectomy, with restoration of patency in 1 patient. One-year primary and secondary patency rates were 92% and 96%, respectively, at life-table analysis. Conclusions: Residual subclavian vein stenosis after operative thoracic outlet decompression is common in patients with venous thoracic outlet syndrome. Combination treatment with surgical thoracic outlet decompression and intraoperative PTA is a safe and effective means for identifying and treating residual subclavian vein stenosis. Moreover, intraoperative PTA may reduce the incidence of postoperative recurrent thrombosis and eliminate the need for venous stent placement or open venous repair. ( J Vasc Surg 2004;40:599-603.)

Primary axillary-subclavian vein thrombosis, or venous thoracic outlet syndrome, is a relatively uncommon but potentially disabling condition that affects young and otherwise healthy persons. Treatment with anticoagulation therapy alone is suboptimal, resulting in some degree of chronic disability in as many as 70% of patients.1-4 In contrast, there is growing consensus that early diagnosis and thrombolytic therapy followed by operative rst-rib resection produces the most favorable long-term outcome for the patient.5-7 Whereas surgical treatment is often delayed for several months after thrombolysis, it is now clear that successful subclavian vein thrombolysis may be folFrom the Divisions of Vascular Surgerya and Interventional Radiology,b University of California, San Francisco, and the Division of Vascular Surgery,c Thomas Jefferson University, Philadelphia. Competition of interest: none. Presented at the Sixteenth Annual Meeting of the American Venous Forum, Orlando, Fla, Feb 26-29, 2004. Reprint requests: Darren B. Schneider, MD, Assistant Professor of Surgery and Radiology, Division of Vascular Surgery, 505 Parnassus Ave, Box 0222, San Francisco, CA 94143-0222 (e-mail: SchneiderD@ surgery.ucsf.edu). 0741-5214/$30.00 Copyright 2004 by The Society for Vascular Surgery. doi:10.1016/j.jvs.2004.07.028

lowed immediately by operative thoracic outlet decompression during a single hospitalization.8,9 The potential advantages of such an expedient strategy are that the period of anticoagulation is shortened, patients may return more rapidly to normal activity, and the risk for recurrent thrombosis is reduced. Despite successful subclavian vein thrombolysis and thoracic outlet decompression, residual subclavian vein stenosis due to an intrinsic vein lesion is common.10-12 The available options for treating intrinsic subclavian vein lesions include open venolysis, patch angioplasty, or venous bypass at the time of thoracic outlet decompression or percutaneous transluminal angioplasty (PTA) or stent placement postoperatively. Most treatment algorithms now advocate that PTA be performed several days to 1 month after surgical decompression.7,9,10 However, delaying treatment of residual subclavian vein stenosis may increase the risk for recurrent thrombosis in the postoperative period. We hypothesized that residual subclavian vein stenosis can be safely and effectively treated with intraoperative PTA at the time of operative thoracic outlet decompression, thereby eliminating any ow-limiting lesion and minimizing the risk for postoperative recurrent thrombosis. This 599

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Table I. Patient presentation and initial treatment

No. of patients Subclavian vein thrombosis Thrombolysis Immediate operation* Delayed operation Anticoagulation therapy only Subclavian vein stenosis without thrombosis 23 21 7 14 2 2

*Surgical decompression performed less than 24 hours after thrombolysis. Surgical decompression performed more than 24 hours after thrombolysis.

study prospectively evaluated this 1-stage treatment algorithm for venous thoracic outlet syndrome with clinical and objective duplex ultrasound follow-up of subclavian vein patency. PATIENTS AND METHODS Over 3 years 25 consecutive patients (16 women, 9 men; median age, 30 years) underwent treatment of venous thoracic outlet syndrome with a standard protocol at 2 institutions. Patients with acute subclavian vein thrombosis or symptomatic subclavian vein stenosis were included in the study, and patients with chronic (4 weeks) subclavian vein occlusion were specically excluded. All patients had clinical symptoms, including arm swelling in 100% and arm pain or a sensation of arm heaviness in 21 of 25 patients (84%). Twenty-three of 25 patients (92%) had acute subclavian vein thrombosis, and the remaining 2 patients (8%) had severe subclavian vein stenosis without thrombosis. Of the 23 patients with subclavian vein thrombosis, thrombus was limited to the subclavian and axillary veins in 21 patients (91%), and 2 patients (9%) had extensive upper extremity thrombosis with involvement of the subclavian, axillary, basilica, and brachial veins. In total, 21 patients (84%) underwent preoperative thrombolysis to treat axillosubclavian vein thrombosis. Seven of 21 patients (28%) with axillosubclavian vein thrombosis underwent thrombolysis at our institutions, followed by immediate surgical decompression without an intervening period of anticoagulation therapy. Fourteen of 21 patients (56%) underwent thrombolysis at other institutions before referral to our institutions; therefore these patients underwent delayed surgical decompression after a variable period of anticoagulation with warfarin sodium (mean delay, 2.2 months; range, 0.5-7 months). An additional 2 patients (8%) with acute subclavian vein thrombosis received treatment at other institutions, with anticoagulation alone without thrombolysis, and spontaneous recanalization of the subclavian vein was conrmed at venography before operation (Table I). Positional venograms documenting compression of the subclavian vein with arm abduction were used to establish the diagnosis of venous thoracic outlet syndrome and to conrm patency of the subclavian vein in all patients before operation. Venography of the contralateral, unaffected extremity was not performed routinely. All patients under-

went surgical thoracic outlet decompression under general endotracheal anesthesia. The rst 23 consecutive operations (92%) included rst-rib resection, with anterior and middle scalenectomy performed through a paraclavicular approach with combined supraclavicular and infraclavicular incisions.13 The last 2 patients (8%) underwent rst-rib resection through a single infraclavicular incision. In all patients the costoclavicular space was completely decompressed by anterior division of the rst rib at the costosternal junction. In some patients, when indicated by operative ndings, subclavian vein venolysis was performed, but direct subclavian vein repair or bypass was not performed in any patients. Closed suction drains were left in all patients. At completion of surgical decompression all 25 patients underwent venography with digital subtraction uoroscopy in the operating suite. The basilic vein in the distal arm was catheterized under ultrasound guidance, and venography was performed with the arm in both adducted and abducted positions to conrm that positional subclavian compression was relieved with surgical decompression. In patients with residual subclavian vein stenosis (50%) PTA was performed with standard techniques. PTA was performed with 10-mm, 12-mm, or 14-mm angioplasty balloons, and high-pressure balloon ination up to 20 atm was used when necessary. Heparin was selectively administered in some patients during PTA, at the discretion of the surgeon. Completion venography after PTA was performed in both adducted and abducted positions to conrm the adequacy of thoracic outlet decompression and subclavian vein PTA. Patients were given daily aspirin therapy, and did not routinely receive anticoagulation therapy postoperatively. According to a prospective surveillance protocol, duplex ultrasound scanning was performed before hospital discharge and at 1, 6, and 12 months postoperatively. Patency data was analyzed with the life table method.14 RESULTS All 25 patients underwent intraoperative venography after surgical decompression. Persistent subclavian vein stenosis was identied on venograms in 16 patients (64%) (Figs 1 and 2). All 16 patients with residual subclavian vein stenosis underwent PTA, with a 100% technical success rate, dened as less than 30% residual stenosis and decreased or absent collateral vein lling. Completion venography performed with the arm in both the adducted and abducted positions conrmed successful surgical decompression, dened by absence of positional subclavian vein compression in all patients. Venous stents were not placed in any patients. There were no deaths. Complications included wound hematoma requiring repeat exploration in 3 patients (12%), postoperative subclavian vein rethrombosis in 2 patients (8%), and phrenic nerve dysfunction in 1 patient (4%). All 3 patients in whom wound hematomas developed had received intravenous heparin during the operation, to prevent thrombosis of severe subclavian vein stenoses. Both patients with postoperative subcla-

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Fig 1. Right upper extremity venograms in a 19-year-old woman with a history of right subclavian vein thrombosis that was treated with heparin, with spontaneous subclavian vein recanalization documented at venography. A, Preoperative venogram during arm abduction demonstrates positional occlusion of the right subclavian vein and multiple venous collateral vessels. B, Intraoperative venogram in the same patient after surgical thoracic outlet decompression shows subclavian vein stenosis with residual chronic thrombus. C, Completion venogram after PTA with 12-mm balloon demonstrates widely patent subclavian vein with the arm abducted.

Fig 2. Left upper extremity venograms. A, Preoperative venogram after successful thrombolysis demonstrates subclavian vein stenosis within the costoclavicular space. B, Completion venogram after PTA with 14-mm balloon demonstrates widely patent subclavian vein with the arm abducted.

vian vein recurrent thrombosis had undergone intraoperative PTA for treatment of persistent subclavian vein stenosis. In addition, both patients had initially had extensive upper extremity venous thrombus, including thrombosis of the brachial basilic veins. Postoperative recurrent thrombosis in both patients was treated with percutaneous mechanical thrombectomy with an AngioJet device (Possis), with successful restoration of venous patency in 1 patient. Twenty-four of 25 patients (96%)

had patent subclavian veins at hospital discharge, as demonstrated on duplex ultrasound scans. Four patients (16%) were discharged with warfarin therapy, including both patients with postoperative recurrent thrombosis and an additional 2 patients with nonocclusive subclavian vein thrombus that was detected on postoperative duplex ultrasound scans. The remaining 21 patients (84%) were discharged with daily aspirin without postoperative warfarin therapy.

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Table II. Life table of primary subclavian vein patency

Interval (mo) 0-1 1-3 3-6 6-12 No. at risk at beginning of interval 25 23 20 19 No. failed during interval 2 0 0 0 No. withdrawn during interval 0 3 1 7 Interval failure rate 0.08 0 0 0 Cumulative patency rate (%) 92.00 92.00 92.00 92.00

SE (%) 5.20 5.43 5.82 5.97

Table III. Life table of secondary subclavian vein patency

Interval (mo) 0-1 1-3 3-6 6-12 No. at risk at beginning of interval 25 24 21 20 No. failed during interval 1 0 0 0 No. withdrawn during interval 0 3 1 7 Interval failure rate 0.04 0 0 0 Cumulative patency rate (%) 96.00 96.00 96.00 96.00 Standard error (%) 3.84 3.92 4.19 4.29

Overall mean follow-up was 10 months, with 6-month follow-up in 19 patients (76%) and 1-year follow-up in 12 patients (48%). One-year primary and secondary subclavian vein patency was 92% and 96%, respectively, at life table analysis (Tables II and III). The patient with an occluded subclavian vein at discharge received warfarin therapy, and spontaneous vein recanalization was conrmed at Duplex ultrasound examination 6 months later. All patients discharged with a patent subclavian vein (96%) experienced durable relief of arm swelling and pain. DISCUSSION The goal of treatment of venous thoracic outlet syndrome is to achieve durable subclavian vein patency to avert chronic disability from persistent venous obstruction and hypertension. There is growing consensus that early diagnosis followed by thrombolysis and operative thoracic outlet decompression restores venous patency and relieves extrinsic venous compression, achieving the most favorable results.5,7-10,15 However, thoracic outlet decompression does not directly address intrinsic subclavian vein stenosis caused by injury of the vein from chronic compression. These residual intrinsic lesions of the subclavian vein are not uncommon, and by impeding ow are presumed to be the cause of treatment failure due to recurrent venous thrombosis.16 As an adjunct to operative thoracic outlet decompression, catheter-based approaches for treatment of persistent, intrinsic subclavian vein stenoses have become popular.6,10,12 Of importance, PTA is not a substitute for operative thoracic outlet decompression, and is ineffective in this regard.8,10,17 Stent placement in lieu of surgery has also been attempted, with little success because stents are subject to compression between the clavicle and rst rib, which often results in stent fracture and frequent subclavian recurrent thrombosis.18,19 However, PTA and possibly stent placement are effective means of eliminating persistent

subclavian vein stenosis after operative thoracic outlet decompression has been performed.12 It appears reasonable to infer that persistent stasis due to a ow-limiting subclavian vein lesion in combination with the local trauma of thoracic outlet decompression may create a prothrombotic milieu in the early postoperative period. Indeed, before this study several of our patients experienced recurrent thrombosis during the 3-day waiting period before performance of venography and PTA of persistent subclavian stenosis. We reasoned that by combining surgical thoracic outlet decompression and intraoperative PTA into a 1-stage operation we could promptly eliminate both the extrinsic and the intrinsic subclavian vein stenosis, thereby reducing stasis and minimizing the risk for postoperative recurrent thrombosis. The results of this study suggest that intraoperative angioplasty may substantially reduce this common mode of treatment failure. We identied persistent subclavian vein stenosis in more than 60% of our patients, and found that PTA used alone is an effective means of treating persistent subclavian vein stenosis after thoracic outlet decompression. In contrast, Kreienberg et al12 reported placement of venous stents in 61% of their patients after PTA alone failed to eliminate persistent subclavian vein stenoses. This discrepancy in part reects our bias against placement of venous stents in the subclavian veins in young, otherwise healthy persons. In our experience balloon ination pressures in excess of 10 atm are occasionally necessary to successfully dilate the broelastic subclavian vein lesions that are commonly present in patients with venous thoracic outlet syndrome. Moreover, high rates of failure of subclavian vein stents have been reported, perhaps because of the mobility of the shoulder joint and of the axillary and subclavian veins.20,21 Because the long-term durabilty of subclavian vein stents remains to be dened and there have been numerous reports of high rates of recurrent stenosis, occlusion, and need for repeat intervention after placement of

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stents in the subclavian and axillary veins, we have avoided stent placement in our patients.21-23 The absence of subclavian vein recurrent thrombosis during follow-up after thoracic outlet decompression and PTA further supports avoidance of stents in favor of PTA alone in patients with persistent subclavian vein stenosis after thoracic outlet decompression. However, longer follow-up is necessary to conrm the durability of subclavian vein PTA in patients with venous thoracic outlet syndrome. Our current preference is to perform thoracic outlet decompression immediately after successful thrombolysis, which is safe and effective.8,9 While it is our preference to perform immediate operation after thrombolysis, it must be emphasized that approximately half of the patients in this series underwent thrombolysis at delayed surgical decompression after thrombolysis performed at other institutions, because of regional referral practices. It should also be noted that 2 patients in our series had subclavian vein stenoses without subclavian vein thrombosis, and these patients may have been at lower risk for recurrent thrombosis. Nonetheless, when possible, we combine the treatment of venous thoracic outlet syndrome into a 1-stage protocol, with immediate operation, including intraoperative venography, and PTA during a single hospitalization. This shortens the duration of treatment, permits earlier return of patients to normal activity, and eliminates the need for prolonged anticoagulation therapy. Before this study we reported treatment of subclavian stenosis during surgical thoracic outlet decompression, with open circumferential venolysis and patch angioplasty of the subclavian vein, if necessary. Residual stenosis was treated postoperatively with percutaneous angioplasty in 4 of 24 patients. In the context of acute subclavian vein thrombosis, this resulted in durable patency and symptom relief without routine use of anticoagulation therapy postoperatively.7 Likewise, in the current study we found routine use of postoperative anticoagulation therapy unnecessary after combined open decompression and intraoperative PTA. Currently we reserve postoperative anticoagulation therapy for patients with recurrent subclavian vein recurrent thrombosis and patients with evidence of residual subclavian vein thrombus on postoperative duplex ultrasound scans. In conclusion, the ndings of this study suggest that combination treatment of venous thoracic outlet syndrome with intraoperative venography and PTA is a safe, efcient, and effective method of identifying and treating residual subclavian vein stenosis after operative thoracic outlet decompression. Residual subclavian vein stenosis is commonly present after operative thoracic outlet decompression, and may be effectively managed with PTA alone. Subclavian vein stent placement is rarely indicated, and routine placement of subclavian vein stents in patients with venous thoracic outlet syndrome should be discouraged.
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