Aggressive treatment of idiopathic axillo-subclavian vein thrombosis provides excellent long-term function

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1 From the New England Society for Vascular Surgery Aggressive treatment of idiopathic axillo-subclavian vein thrombosis provides excellent long-term function David H. Stone, MD, a Salvatore T. Scali, MD, a Aja A. Bjerk, BS, a Eva Rzucidlo, MD, a Catherine K. Chang, MD, a Philip P. Goodney, MD, a Brian W. Nolan, MD, a,b and Daniel B. Walsh, MD, a Lebanon, NH Objective: While much attention has been devoted toward treatment paradigms for idiopathic axillo-subclavian vein thrombosis (ASVT), little has focused on long-term durability of aggressive treatment and its associated functional outcomes. The purpose of this study was to review our own surgical therapeutic algorithm and its associated durability and functional outcomes. Methods: All patients treated with combined endovascular and open surgery at Dartmouth-Hitchcock Medical Center for ASVT from 1988 to 2008 were identified. Patient demographics, comorbidities, and operative techniques were recorded. Patency, freedom from reintervention, and functional outcomes were documented. Follow-up via telephone and clinic visit allowed quantitative comparison of functional status, pre- and postoperatively. Results: Thirty-six patients were treated for ASVT throughout the study interval. Seven patients (19.4%) were lost to follow-up. Most patients were male (66%; N 24); mean age was 32 years. Catheter-directed thrombolysis was utilized in the majority of patients (83.3%; N 30) with an average time from symptom onset to lysis of 12 days. Surgical decompression was undertaken in all patients via transaxillary (52%; N 19), supraclavicular (31%; N 11), or infraclavicular approaches (17%; N 6). Eleven stents were placed in 11 patients (30.5%) for residual stenotic disease. Mean follow-up was 65 months, with 1- and 5-year overall patency at 100% and 94%, respectively. Freedom from reintervention was 100% and 74.4% at 1 and 5 years, respectively. Seven patients (19.4%) required postoperative reintervention with four receiving additional lytic therapy, two requiring a stent, and one venoplasty. At presentation, 65.5% (N 19) of patients were unable to work or perform routine activities. After treatment, 86% (N 25) returned to their employment and have experienced sustained symptomatic and functional improvement. Conclusions: Patients with symptomatic idiopathic axillo-subclavian vein thrombosis can expect durable patency with sustained freedom from reintervention following aggressive combined endovascular and surgical treatment. Good functional outcomes can be expected in patients with relief of symptoms and return to work. (J Vasc Surg 2010;52: ) Since its initial description in the latter 19th century by Sir Paget and Von Schroetter, the therapeutic algorithm for treatment of effort-induced axillo-subclavian vein thrombosis (ASVT) has undergone a considerable evolution. Early management strategies featuring conservative treatment, including extremity elevation, warm compresses, and anticoagulation, were supplanted by therapeutic protocols currently involving antecedent thrombolytic therapy followed by staged surgical thoracic outlet decompression. 1,2 More recently, attempts to further refine combined endovascular and surgical treatment approaches have been the subject of many reports, with various authors espousing the From the Section of Vascular Surgery, Dartmouth-Hitchcock Medical Center a and The Dartmouth Institute for Health Policy and Clinical Practice, Center for Leadership and Improvement. b Presented at the Thirty-sixth Annual Meeting of the New England Society of Vascular Surgery, Boston, Mass, October 3, Reprint requests: David H. Stone, MD, Section of Vascular Surgery, Dartmouth-Hitchcock Medical Center, One Medical Center Dr., Lebanon, NH ( david.h.stone@hitchcock.org). The editors and reviewers of this article have no relevant financial relationships to disclose per the JVS policy that requires reviewers to decline review of any manuscript for which they may have a competition of interest /$36.00 Copyright 2010 by the Society for Vascular Surgery. doi: /j.jvs merits and pitfalls of their preferred respective algorithms. 1,3-5 By comparison, little attention has been devoted to the natural history and long-term functional outcomes of such patients following invasive therapies. Indeed, such follow-up remains critical in this highly active, otherwise healthy patient population. The purpose of this study was to assess the treatment evolution for idiopathic axillosubclavian vein thrombosis at Dartmouth-Hitchcock Medical Center, and in doing so, document long-term overall treatment patency and functional outcomes, measured as sustained return to work and durable symptom relief. METHODS All patients treated for idiopathic axillo-subclavian vein thrombosis from 1988 to 2008 were retrospectively identified from the Section of Vascular Surgery database at Dartmouth-Hitchcock Medical Center. Neurogenic and arterial thoracic outlet syndrome cases were excluded from further review. Patients with catheter-induced upper extremity axillo-subclavian venous thromboses were not included in the study cohort. Patient demographics, comorbidities, and operative technique were recorded. Overall vein patency, freedom from reintervention, and functional outcomes were the primary end points of the study. Clinic 127

2 128 Stone et al JOURNAL OF VASCULAR SURGERY July 2010 Table I. Demographics and comorbidities Male 67% Mean age (male) 30 years (17-51) Mean age (female) 34 years (14-54) Right upper extremity 83% Left upper extremity 17% Diabetes 0% Hypertension 0% Hypercholesterolemia 0% Tobacco use 8% Hypercoaguable state 0% Right upper extremity denotes the laterality of disease. follow-up with color venous duplex ultrasonography was performed in all patients. A standardized interview was performed in the clinic or by telephone with all patients to assess functional outcomes, measured by sustained return to work and durable symptom relief. Statistical analysis. Overall vein patency throughout the study interval and freedom from reintervention was performed using Kaplan-Meier life table analysis with Stata software (College Station, Tex). Fig 1. Surgical approach utilized throughout the study interval. Historically, a greater percentage of patients underwent transaxillary surgical decompression; however, more recently, an infraclavicular technique has been adopted. Fig 2. Current multidisciplinary treatment algorithm for idiopathic axillo-subclavian vein thrombosis. RESULTS Over the entire study interval ( ), 65 patients with a diagnosis of thoracic outlet syndrome were identified and treated with comprehensive therapy including thoracic outlet decompression surgery. Fifty-seven percent (N 36) were treated for idiopathic axillo-subclavian vein thrombosis, while 41% (N 26) were treated for neurogenic thoracic outlet syndrome. Three patients (2%) underwent treatment for arterial thoracic outlet syndrome. Both neurogenic and arterial thoracic outlet patients were excluded from further analysis. There was no substantial change in the frequency of presentation of each respective diagnosis to our institution over the study period. Sixty-seven percent (N 24) of the patients were male, with a mean age of 30 years (range, years). Female counterparts were only slightly older (mean, 34 years). Eighty-three percent of treated cases were right sided, in concordance with the prevalence of right-hand dominance. Most patients were devoid of typically associated vascular comorbidities. No patients were determined to have an underlying hypercoaguable state (Table I). Average time from the onset of symptoms to presentation at Dartmouth-Hitchcock Medical Center was 12 days (range, 1-60 days). Eighty-three percent (N 30) of patients underwent initiation of catheter-directed thrombolytic therapy throughout the study interval. All patients were successfully lysed. Throughout the entire study, different lytic agents were utilized. Ten percent received Streptokinase, reflecting the earliest experience using antecedent lytic therapy. This was later supplanted over time by Urokinase, in 33% of the cohort. More recently, the remaining 57% of our patients received tpa, as our treatment protocol evolved. Currently, our thrombolytic therapy algorithm involves ultrasound-guided ipsilateral upper extremity venous access. A multi-side holed catheter is advanced across the thrombosed venous segment, and tpa infusion is initiated (1 mg/hr), with subsequent reimaging at 12-hour intervals to assess recanalization. There was no difference in efficacy or observed lysis complications over time among lytic agents including allergic reaction (N 1) or hematoma formation (N 4). No patients required transfusion or surgical exploration in the setting of their hematomas. Over the study interval, there has been a transition from the well-described transaxillary approach to an infraclavicular dissection technique. Specifically, 19 patients (52%) underwent surgical decompression of the thoracic outlet via a transaxillary approach. Eleven patients (31%) received a supraclavicular surgical decompression, whereas the remaining six patients (17%) underwent surgery via an infraclavicular approach (Fig 1). Four patients underwent intraoperative patch venoplasty in the setting of intrinsic venous anatomic deformities including fibrotic scarring or webs. No patients required transsternal extension of their incisions for medial disease. Rather, 11 stents were placed in 11 patients for residual stenotic disease (defined as 50% stenosis on completion venogram). Eight stents (73%) were placed intraoperatively, while one was placed preprocedur-

3 JOURNAL OF VASCULAR SURGERY Volume 52, Number 1 Stone et al 129 impairing symptoms. No patients experienced chronic arm swelling over the course of the study interval. Fig 3. Kaplan-Meier overall axillo-subclavian venous patency throughout the study interval. Fig 4. Kaplan-Meier freedom from reintervention throughout the study interval. ally, prior to surgical decompression. Two stents were placed postprocedurally, reflecting our earlier approach using this percutaneous adjunct (Fig 2). Overall, vein patency throughout the study interval was determined by duplex ultrasound. Over the 20-year period, durable patency was achieved, with 100% 1-year patency and 94% 5-year patency, respectively (Fig 3). Likewise, sustained freedom from reintervention was also observed, with 100% freedom at 1-year and 77.4% at 5-year follow-up (Fig 4). Functional assessment was recorded for all patients throughout the study using a standardized questionnaire/ interview. At the time of presentation, 65% (N 19) of patients reported substantial impairment of their affected extremity, citing inability to work, exercise, or perform routine activities of daily living. Following aggressive treatment, only 14% (N 4) of patients admitted to ongoing DISCUSSION This study is among the few to document long-term patency and functional outcomes among patients with idiopathic axillo-subclavian vein thrombosis. Since its initial description in the late 1800s, most studies have described and documented therapeutic methodology for the effective management of effort-induced axillo-subclavian vein thrombosis. 1,3,6-10 Comparatively few have addressed functional outcomes in these otherwise young, healthy, active patients. Naturally, such outcomes have a profound impact on the merits of any multidisciplinary therapy, regardless of documented vein patency. Currently, aggressive endovascular and open surgical treatment is predicated on the presumption that afflicted patients experience pervasive functional limitations. Historically, this posture may reflect an era of more limited diagnostic capability, subsequently permitting less impaired patients to elude accurate diagnosis. Consequently, it is likely that only a smaller subset of patients with more progressive symptoms would seek consultation and treatment. In their 2006 report, Persson et al document the natural history of 31 contemporary patients with idiopathic axillo-subclavian vein thrombosis treated with only anticoagulation. 11 Perhaps unexpectedly, the authors demonstrated no association between the patients postthrombotic symptoms and their venous hemodynamics. The authors, moreover, cite that 77% of patients in their study experienced persistent symptoms, while only 30% progressed to moderate-grade postthrombotic syndrome features. Unfortunately, it remains unclear from this study whether the documented persistent symptoms precluded a patient s ability to return to work. This study, by comparison, documents that 65% (N 19) of patients on presentation were unable to perform their respective jobs due to disabling symptoms. By comparison, only 14% (n 4) of patients remained significantly impaired and unable to work following multidisciplinary therapy. The natural history of patients treated without multimodal therapy was not part of this study. Based on these findings, however, one can infer that an indeterminate number of patients can anticipate adequate function regardless of treatment, even in the setting of a chronically occluded axillo-subclavian vein. As reported by de Leon et al, many such patients with chronically occluded axillo-subclavian veins will recanalize while on anticoagulation, with resolution of their respective symptoms over time. 2 Despite this posture toward chronically impaired patients, this study demonstrates that a majority of patients who present acutely with symptoms causing impairment will benefit from aggressive therapy. This study documents excellent long-term overall patency of the axillo-subclavian venous segment with aggressive combined endovascular and open surgical treatment. Over the study interval, our surgical approach has evolved from the well-described transaxillary approach to an infraclavicular surgical technique. As documented by Molina et

4 130 Stone et al JOURNAL OF VASCULAR SURGERY July 2010 al, this approach is highlighted by improved venous exposure, thereby permitting circumferential dissection from surrounding tissues and patch venoplasty when needed. 12 Moreover, this surgical technique permits medial extension across the manubrium to effectively treat residual stenoses. Although Molina et al report that the partial transsternal approach is well tolerated, this study validates the use of stenting for treating residual medial stenoses, thereby obviating the need for any surgical division of the sternum. As described by Molina et al, we currently have adopted 8 weeks of formal anticoagulation with concomitant antiplatelet therapy. 12 Although no associated hypercoaguable states were identified in this series, extended anticoagulation treatment strategies would be favored accordingly in this setting. The role of stenting the venous segment has been the subject of ongoing debate. Many remain unenthusiastic about placing stents in the venous system, noting a perceived inflammatory reaction, which may limit durability. 2,7 Indeed, the use of catheter-based therapies as an adjunct to surgical decompression therapy has been controversial, especially among earlier reports. Green et al, among others, have speculated that stent placement could stimulate a hyperplastic response, thereby leading to rethrombosis. 7 Alternatively, favorable outcomes have since been described using stenting in the setting of idiopathic axillo-subclavian vein thrombosis. Used selectively, stenting has been utilized with moderate success. Kreinberg et al cited a 64% stent patency over a mean follow-up period of 3.5 years. 13 This study corroborates this finding, documenting good overall patency at both 1 and 5 years among patients treated with selective stenting for residual stenoses ( 50%). Despite these findings, endoluminal stenting in this setting reflects relatively small, single-center experiences rather than large patient cohorts. Nevertheless, stenting in this series did offer durable midterm results. Furthermore, if one considers the relatively benign natural history of many patients with chronically occluded axillo-subclavian venous segments, 2 we maintain that stenting is preferable to the alternative of partial sternotomy for treating residual medial stenoses. Therefore, when used in combination with an infraclavicular technique, we propose the modified Molina approach as the preferred treatment method for patients with idiopathic axillo-subclavian vein thrombosis. It should be noted, however, that this study is not sufficiently powered to reach any definitive conclusions on comparative long-term outcomes between stented and unstented patients. It remains possible that stenting these lesions may expedite short interval functional recovery, while its role in chronic patient function remains less defined, regardless of venous patency. This study has several intrinsic limitations. First, this remains a single-center retrospective study with a modest size patient cohort, with seven patients lost to follow-up over a 20-year period. It should be noted, however, that historically, many series for idiopathic ASVT have been relatively small in size. In addition, there was no standardized treatment throughout the study interval. Patients were treated according to surgeon discretion. Moreover, our preferred treatment algorithm has evolved over time. Nevertheless, this series does successfully document realworld functional and treatment outcomes at a tertiary care center. In addition, functional data were predicated on our patient questionnaire and standardized telephone interview. These questions were designed to capture a focused assessment on the patient s employment continuity, ability to perform daily activities, sustained disability, and ongoing narcotic/pain medication dependence. While not a validated questionnaire, this interview still offers a valid depiction of a patient s subjective disposition regarding his or her respective functional status. CONCLUSIONS Based on our review of treatment for patients with idiopathic axillo-subclavian vein thrombosis over a 20-year interval, patients can expect durable overall patency with sustained freedom from reintervention. Symptomatic patients with acute thromboses will experience substantial functional improvement with a combined endovascular and surgical approach using a selective stenting posture toward treating residual medial venous stenoses. The natural history of patients with documented chronically occluded axillo-subclavian veins remains somewhat unknown and should be considered when considering aggressive surgical intervention. AUTHOR CONTRIBUTIONS Conception and design: DS, DW Analysis and interpretation: DS, SS, ER, PG, DW Data collection: DS, SS, AB Writing the article: DS Critical revision of the article: DS, SS, ER, CC, PG, BN, DW Final approval of the article: DS, DW Statistical analysis: PG, BN Obtained funding: N/A Overall responsibility: DS, DW REFERENCES 1. AbuRahma AF, Sadler D, Stuart P, Khan MZ, Boland JP. Conventional versus thrombolytic therapy in spontaneous (effort) axillary-subclavian vein thrombosis. Am J Surg 1991;161: de Leon RA, Chang DC, Hassoun HT, Black JH, Roseborough GS, Perler BA, et al. Multiple treatment algorithms for successful outcomes in venous thoracic outlet syndrome. Surgery 2009;145: AbuRahma AF, Sadler DL, Robinson PA. Axillary subclavian vein thrombosis. Changing patterns of etiology, diagnostic, and therapeutic modalities. Am Surg 1991;57: Angle N, Gelabert HA, Farooq MM, Ahn SS, Caswell DR, Freischlag JA, Machleder HI. Safety and efficacy of early surgical decompression of the thoracic outlet for Paget-Schroetter syndrome. Ann Vasc Surg 2001;15: Urschel HC Jr, Razzuk MA. Paget-Schroetter syndrome: what is the best management? Ann Thorac Surg 2000;69:1663-8; discussion Aziz S, Straehley CJ, Whelan TJ Jr. Effort-related axillosubclavian vein thrombosis. A new theory of pathogenesis and a plea for direct surgical intervention. Am J Surg 1986;152:57-61.

5 JOURNAL OF VASCULAR SURGERY Volume 52, Number 1 Stone et al Green RM, Waldman D, Ouriel K, Riggs P, Deweese JA. Claviculectomy for subclavian venous repair: long-term functional results. J Vasc Surg 2000;32: Thompson RW, Schneider PA, Nelken NA, Skioldebrand CG, Stoney RJ. Circumferential venolysis and paraclavicular thoracic outlet decompression for effort thrombosis of the subclavian vein. J Vasc Surg 1992;16: Melby SJ, Vedantham S, Narra VR, Paletta GA Jr, Khoo-Summers L, Driskill M, Thompson RW. Comprehensive surgical management of the competitive athlete with effort thrombosis of the subclavian vein (Paget-Schroetter syndrome). J Vasc Surg 2008;47:809-20; discussion Caparrelli DJ, Freischlag J. A unified approach to axillosubclavian venous thrombosis in a single hospital admission. Semin Vasc Surg 2005;18: Persson LM, Arnhjort T, Larfars G, Rosfors S. Hemodynamic and morphologic evaluation of sequelae of primary upper extremity deep venous thromboses treated with anticoagulation. J Vasc Surg 2006; 43:1230-5; discussion Molina JE, Hunter DW, Dietz CA. Paget-Schroetter syndrome treated with thrombolytics and immediate surgery. J Vasc Surg 2007;45: Kreienberg PB, Chang BB, Darling RC 3rd, Roddy SP, Paty PS, Lloyd WE, et al. Long-term results in patients treated with thrombolysis, thoracic inlet decompression, and subclavian vein stenting for Paget- Schroetter syndrome. J Vasc Surg 2001;33(2 Suppl):S Submitted Dec 15, 2009; accepted Jan 28, COLLECTIONS OF PAPERS On the Web version of the Journal, selected articles have been grouped together for the convenience of the readers. The current collections include the following: American Board of Vascular Surgery Editorial Comments History Reporting Standards Technical Notes Basic Science Reviews Guidelines Lifeline Research Meeting Abstracts Reviews