The Society for Vascular Surgery (SVS) applauds the recent federal commitment to improve the lives of patients through studies to determine the most effective treatments for a broad range of medical conditions. Attention to health care cost containment is essential to maintain the superiority of our health care system. In view of the rapid growth of the elderly population, the demographic segment in whom vascular disease predominates, we believe that vascular disease represents a very important area for objective research. Currently, 12 million Medicare beneficiaries are being treated for peripheral arterial disease at a cost of approximately $151 billion. Therefore, the SVS fully endorses the concept of comparative effectiveness research, has a demonstrated record of expertise and commitment to this process, including defining and publishing peer-reviewed practice guidelines, and is eager to participate actively in the design and implementation of these studies as they relate to vascular ailments. The SVS endorses the full evaluation of all clinical options for the treatment of vascular disease to ensure that the highest possible quality of care is available to patients. The SVS believes that comparative effectiveness initiatives in vascular disease should begin by addressing these areas of priority: Stroke is the third leading cause of death, the second leading cause of dementia, and the leading cause of adult disability in the United States. Further, the prevalence of stroke increased exponentially among those aged >65 years, and especially those aged >75, the fastest growing segment of the population. Carotid artery occlusive disease is a common and preventable cause of ischemic stroke. Large randomized controlled trials have previously established the appropriate indications for carotid endarterectomy. However, evolving and improving medical therapy and the introduction of endovascular carotid angioplasty and stenting have complicated the question of the optimal treatment for the patient with carotid artery disease, especially in individuals with asymptomatic carotid stenoses. Objective research is clearly needed in this area. In recent years we have witnessed the rapid development and adoption of minimally invasive and expensive technologies to treat lower extremity arterial disease despite a paucity of critical data supporting clinical effectiveness and cost efficacy. This has led to an environment where patients and providers are not sufficiently informed to decide what the best and most cost-effective treatment modality is in a particular case. The SVS believes that nonoperative, endovascular, and operative treatment strategies should be closely examined within the context of comparative effectiveness. The treatment of venous reflux and obstructive disease represents an understudied aspect of venous disease, and yet in recent years, we have seen an exponential growth in the performance of minimally invasive new technologic procedures to treat this very common clinical disorder. The importance of venous disease as a topic of study lies in its prevalence and the overall lack of high-quality comparative data. In addition, patients with venous disease represent a younger cohort compared with those with arterial disease. These patients often suffer from substantial morbidity that likely carries a significant societal burden with lost workdays and long-term disability. To help promote an understanding of comparative effectiveness research among clinicians, the SVS commits to:•providing formal education to its members about comparative effectiveness research so that vascular surgeons can participate in such studies and successfully use the results to improve patient care;•continuing development of practice guidelines, reporting standards, and quality measures that can form the foundation of comparative effectiveness research;•urging the publishers of vascular studies to embrace the methodologies of comparative effectiveness research and insist that research articles be based on high-quality evidence;•studying the role of comparative effectiveness research in maintenance of certification activities;•working to ensure that the Vascular Registry contains data elements conducive to comparative effectiveness research;•encouraging open dialogue with other professional societies regarding comparative effectiveness initiatives;•working with payors to document and promote comparative effectiveness research; and to•working with the medical industry to establish guidelines for studying clinical and cost efficacy of new technologies and treatments. The SVS supports the promotion of high-quality, data-driven vascular care. We believe that comparative effectiveness research plays an important role in the development of a more sustainable American health care system and can significantly improve the health of patients, their families, and their communities. We believe that collaboration between practitioners and payors, including the federal government, is appropriate and essential to conducting the necessary high quality research to optimize patient care in the future in the most cost effective fashion. The SVS is uniquely poised to lead in this process.

Editor: A 66-year-old man with severe comorbidities underwent open abdominal aortic aneurysm repair. The patient had a complicated postoperative course with respiratory failure eventually requiring a tracheostomy. Seven days after placement of a right subclavian central venous catheter (Cordis, Miami Lakes, FL) the patient developed severe respiratory distress. Fiberoptic bronchoscopy revealed extraluminal compression of the retrosternal trachea requiring passage of a 6.0-mm endotracheal tube through the tracheostomy. Computed tomography of the thorax demonstrated a right subclavian pseudoaneurysm extending into the mediastinum and compressing the trachea. An angiogram confirmed a large subclavian pseudoaneurysm at the level of the origin of the right vertebral artery. As a result of the patient's high surgical risk and history of median sternotomy, the traditional open operative repair, which would require another thoracotomy for proximal control, was not selected. Instead, endovascular repair with a covered stent was considered. However, the close proximity of the vertebral artery origin prohibited immediate intervention. To protect the vertebral artery from being occluded in the planned implantation of a covered stent, the origin of the right vertebral artery from the subclavian artery was transposed approximately 3 cm distal to the pseudoaneurysm neck. After ligation of the vertebral artery stump, a polytetrafluoroethylene graft from the transposed distal vertebral artery origin was anastomosed to the distal end of the vertebral artery with use of a standard supraclavicular approach (Figure, part a). This transposition allowed for the subsequent placement (at postoperative day 7) of a 4-cmlong Fluency self expanding polytetrafluoroethylene nitinolcovered stent (CR Bard, Murray Hill, NJ) between the origins of the right carotid artery and the bypass graft. From a left common femoral artery access, the right common carotid artery was initially catheterized with a 5-F Davis catheter (Merit Medical, South Jordan, UT) and 0.035-inch Bentson wire (Cook, Bloomington, IN) with subsequent wire removal and catheter connection to a pressurized drip to mark the right internal carotid artery position for subsequent covered stent deployment and to avoid inadvertent coverage of its origin. The right brachial artery was subsequently accessed and the 10-mm × 40-mm stent was then deployed to cover the pseudoaneurysm neck. On angiography at the conclusion of the procedure, there was successful exclusion of the pseudoaneurysm from the arterial circulation without compromising flow to the right vertebral or right carotid arteries (Figure, part b). Five days after stent implantation, a right anterior lateral thoracotomy was performed to drain the residual mediastinal hematoma that had caused marked narrowing of the trachea. The patient underwent successful extubation on postoperative day 4. The patient died in an automobile accident 5 months after the initial transposition procedure. Iatrogenic subclavian artery pseudoaneurysms are a known complication of subclavian or internal jugular central venous catheter placement (1Mansfield PF Hohn DC Fornage BD et al.Complications and failures of subclavian-vein catheterization.N Engl J Med. 1994; 331: 1735-1738Crossref PubMed Scopus (711) Google Scholar). Because of the potential expansion and mass effect of a subclavian artery pseudoaneurysm on adjacent structures, as well as the potential for embolic events, pseudoaneurysms of the subclavian artery are routinely repaired. Traditionally, such injuries are repaired with use of open surgical approaches. However, significant morbidity and mortality is associated with the open techniques of pseudoaneurysm repair. A large series of covered stent–treated arterial lesions was reported by Parodi et al (2Parodi JC Schonholz C Ferreira LM et al.Endovascular stentgraft treatment of traumatic arterial lesions.Ann Vasc Surg. 1999; 13: 121-129Abstract Full Text PDF PubMed Scopus (226) Google Scholar) in 1999 that included 29 cases of traumatic false aneurysms or arteriovenous fistulas (of which nine involved the subclavian artery). Patients were followed for a mean of 24 months and 96% had immediate successful results. With a history of coronary artery bypass grafting adding to an already difficult surgical procedure in this case, we chose an interdisciplinary approach for treatment. The anatomic proximity of the right vertebral artery origin to the neck of the pseudoaneurysm (ie, directly opposite) would have resulted in vertebral artery origin occlusion by the covered stent (Figure, part a). A vertebral artery origin transposition from a supraclavicular approach protected the vertebral artery from potential occlusion during covered stent placement for the pseudoaneurysm and allowed us to take advantage of the endovascular approach, avoiding a median sternotomy. Without transposition, we would have risked vertebral artery occlusion or incomplete coverage of the pseudoaneurysm neck, as described by Watelet et al (3Watelet J Clavier E Reix T et al.Traumatic subclavian artery pseudoaneurysm: periprocedural salvage of failed stent-graft exclusion using coil embolization.J Endovasc Ther. 2001; 8: 197-201Crossref PubMed Scopus (19) Google Scholar). Additional salvage procedures such as coil embolization of the pseudoaneurysm may be required (3Watelet J Clavier E Reix T et al.Traumatic subclavian artery pseudoaneurysm: periprocedural salvage of failed stent-graft exclusion using coil embolization.J Endovasc Ther. 2001; 8: 197-201Crossref PubMed Scopus (19) Google Scholar). A transbrachial approach, instead of a femoral approach, was used for covered stent deployment in our case to provide a more direct access route to the pseudoaneurysm neck, as described by Patel et al (4Patel AV Marin ML Veith FJ et al.Endovascular graft repair of penetrating subclavian artery injuries.J Endovasc Surg. 1996; 3: 382-388Crossref PubMed Scopus (137) Google Scholar). In our experience, the transbrachial approach is safe, but we believe it is prudent to perform surgical closure of the brachial artery puncture site for sheath sizes greater than 7 F, as in our case. Other minimally invasive options include placement of an uncovered stent with wide interstices (eg, Symphony stent; Boston Scientific, Natick, MA) with subsequent coil embolization through the interstices. Risk of this procedure include inability to deliver the coils accurately, requiring additional interventions. Another minimally invasive option is inflation of occlusion balloon across the aneurysm neck and subsequent percutaneous thrombin injection of the pseudoaneurysm (5Criado E Gasparis A Transluminal thrombin injection and exclusion of a paramesenteric abdominal aortic aneurysm.J Vasc Surg. 2004; 39: 1118-1121Abstract Full Text Full Text PDF PubMed Scopus (9) Google Scholar). Thrombin "escape" through the aneurysm neck and embolization into the supraaortic branches would increase the risk of procedure-induced stroke. To our knowledge, long-term studies are not currently available comparing the various minimally invasive approaches.