153 research outputs found

    Centers for Medicare and Medicaid Services conducts a medical evidence development and coverage advisory committee meeting on carotid atherosclerosis

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    Publication of the eagerly anticipated Carotid Revascularization Endarterectomy Versus Stenting Trial in May 2010 was anticipated to engender much activity in the realm of interventions for carotid stenosis. Specifically, a variety of professional societies, including the Society for Vascular Surgery (SVS), published updated practice guidelines in the calendar year 2011, timed to include data from large-scale well-conducted clinical trials comparing carotid endarterectomy with carotid artery stenting (CAS). In anticipation of a renewed application to the Centers for Medicare and Medicaid Services (CMS) to reconsider the national coverage determination for CAS, the SVS Board of Directors voted in June 2011 against any change in the national coverage determination for CAS. CMS convened a Medicare evidence development and coverage advisory committee (MEDCAC) meeting to consider fundamental aspects of the treatment of carotid atherosclerosis on January 25, 2012, to allow an unbiased and current deliberation of the state-of-the-art technology and science referable to the management of carotid atherosclerosis. The MEDCAC differs substantially from a reconsideration of coverage determination and, in this case, was built around seven research questions. The MEDCAC consists of a panel of experts who, after reviewing the literature and submitted comments by interested stakeholders, and after hearing testimony from invited speakers and at-large presentations, held a panel vote on the research questions. Given that management of carotid atherosclerosis is a core element of vascular surgical practice, the SVS had a major presence at the MEDCAC in the form of a comprehensive written document individually considering the research questions and a variety of presentations addressing various aspects in carotid disease management. The purpose of this report is to detail the SVS's position on the MEDCAC research questions referable to the management of carotid atherosclerosis and to otherwise detail the proceedings of the MEDCAC

    Invited commentary

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    SVS invited response

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    Roles for specialty societies and vascular surgeons in accountable care organizations

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    With the passage of the Affordable Care Act, accountable care organizations (ACOs) represent a new paradigm in healthcare payment reform. Designed to limit growth in spending while preserving quality, these organizations aim to incant physicians to lower costs by returning a portion of the savings realized by cost-effective, evidence-based care back to the ACO. In this review, first, we will explore the development of ACOs within the context of prior attempts to control Medicare spending, such as the sustainable growth rate and managed care organizations. Second, we describe the evolution of ACOs, the demonstration projects that established their feasibility, and their current organizational structure. Third, because quality metrics are central to the use and implementation of ACOs, we describe current efforts to design, collect, and interpret quality metrics in vascular surgery. And fourth, because a “seat at the table” will be an important key to success for vascular surgeons in these efforts, we discuss how vascular surgeons can participate and lead efforts within ACOs

    Diagnosis and treatment of thoracic aortic intramural hematoma

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    AbstractPurpose: This report reviews our recent experience with nine patients who had intramural hematoma of the thoracic aorta.Methods: This was a retrospective study of all patients who had intramural hematoma at our institution from 1989 to 1994. Patients who had identifiable intimal flap, tear, or penetrating aortic ulcer were excluded from the study.Results: Among these nine elderly patients (mean age, 76 years), the most common presentation was chest or back pain. Intramural hematoma was diagnosed by a variety of high-resolution imaging techniques. The descending thoracic aorta alone was involved in seven patients, whereas the ascending aorta was affected in the other two patients. One patient had evidence of an aneurysm (5.0 cm diameter) in the region of the hematoma. All patients were initially managed nonsurgically with blood pressure control. Both patients who had ascending aortic involvement had progression of aortic hematoma, which resulted in death in one case and in successful surgery in the other. Six of the seven patients who had descending aortic involvement alone were successfully managed without aortic surgery. The patient who had intramural hematoma and associated aortic aneurysm, however, had severe, recurrent pain and underwent successful aortic replacement. Another patient had recurrent pain associated with hypertension, but was successfully managed nonsurgically with antihypertensive therapy. All eight survivors are doing well at a median follow-up of 19 months.Conclusions: Intramural hematoma appears to be a distinct entity, although overlap with aortic dissection or penetrating aortic ulcer exists. Aggressive control of blood pressure with intensive care unit monitoring has been our initial management. Patients who have involvement of the descending thoracic aorta alone can frequently be managed without surgery in the absence of coexisting aneurysmal dilatation or disease progression. Our experience suggests that a more aggressive approach with early surgery is warranted in patients who have ascending aortic involvement or those who have coexisting aneurysm and intramural hematoma. (J Vasc Surg 1996;24;1022-9.

    Intraoperative determinants of infrainguinal bypass graft patency: A prospective study

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    Objectives:To evaluate a number of currently available methods for intraoperative assessment of infrainguinal bypass grafts (IBG) in terms of detecting technical errors and predicting graft failure.Design:Prospective open clinical study.Methods:Forty-nine patients undergoing 54 consecutive IBG were studied. Intraoperatively, the following measurements were performed: distal pulse palpation (DPP), continuous wave Doppler (CWD), pulse volume recording (PVR), and ultrasonic volume flowmetry (UVF), followed by intraoperative angiography of the entire graft and runoff vessels. The outflow resistance was graded according to the guidelines of the Society for Vascular Surgery and International Society for Cardiovascular Surgery (SVS/ISCVS runoff score). Graft patency was determined noninvasively (PVR, colour Duplex) up to 12 months following surgery. Predictive values and likelihood ratios for the intraoperative tests in detecting a technical problem during the bypass procedure and in predicting early graft failure were calculated.Results:There were five immediate revisions for problems detected intraoperatively. Angiography did not identify any additional problems but assisted in the correct location of the problems detected by the other tests. DPP and CWD were highly significant indicators of the need for revision with likelihood ratios for a positive test of 14.7 (p < 0.01) and 12.3 (p < 0.01) respectively. PVR did not achieve statistical significance in this respect. None of the intraoperative tests was a statistically significant predictor of early graft failure. The SVS/ISCVS runoff score, on the other hand, predicted early failure with a PPV of 33% (likelihood ratio for a positive test of 4.9, p < 0.05). None of the grafts with a perfect SVS/ISCVS runoff score (n = 39) failed in the first postoperative month.Conclusions:Simple CWD insonation of graft and anastomoses is the best intraoperative indicator for technical inadequacies after IBG. Routine intraoperative angiography is not necessary and intraoperative anatomical imaging may be reserved for situations in which noninvasive documentation of technical success is absent. Contrary to the intraoperative haemodynamic test results, the SVS/ISCVS runoff score is a good predictor of early graft failure

    Propensity-matched cohort validates findings of the VALOR trial

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    IntroductionThe Evaluation of the Medtronic Vascular Talent Thoracic Stent Graft System for the Treatment of Thoracic Aortic Aneurysms (VALOR) trial findings noted superior 30-day and 1-year outcomes of the Talent thoracic endograft (Medtronic Vascular, Santa Rosa, Calif) compared with surgical repair of descending thoracic aneurysms (DTAs). Data from 195 prospective thoracic endovascular aneurysm repair (TEVAR) patients treated with the Talent device and 189 retrospective controls undergoing open surgical repair (OSR) from three centers of excellence were included in the trial after completion of TEVAR enrollment and compared. Such comparisons are biased by baseline differences among TEVAR vs OSR, however, propensity score (PS) analysis can reduce bias and validate such comparisons.MethodsLogistic regression was used to generate a PS (range, 0-1) to identify baseline characteristics more likely in TEVAR. The PS estimated the probability that any patient would undergo TEVAR (eg, a PS of 0.99 represents a 99% chance a patient belongs to TEVAR). PSs were then generated for all patients, and TEVAR and OSR patients were divided into tertiles based on the PS to reduce up to 80% of inherent bias. Outcomes from the middle tertile (T2), patients equally likely (midrange PS) to be in TEVAR or OSR and therefore best matched, were compared using regression analysis and were also compared with the outcomes in the overall trial group.ResultsCorrelates of membership in TEVAR were smaller aneurysm (P < .001), anticoagulants (P < .01), no previous abdominal aortic aneurysm (AAA) repair (P < .01), no peripheral vascular disease (P = .001), statin use (P = .002), aspirin use (P = .002), older age (P = .028), race (P = .007), male gender (P = .02), and heart failure (P = .035). T2 included 68 TEVAR (PS, 0.58 ± 0.2) and 67 OSR patients (PS, 0.46 ± 0.2). VALOR overall reported differences in aneurysm size (56 mm TEVAR vs 69 mm open) and prior AAA repair (19% TEVAR vs 37% open), and this adjusted to no differences in T2 patients. In the well-matched T2 cohort, TEVAR patients had similar 30-day mortality (0% vs 3% OSR; P = .2) and improved 1-year aneurysm-related mortality rates (0% TEVAR vs 8% OSR; P = .05) compared with the OSR patients. This finding was in concurrence with the VALOR trial reporting similar benefit in TEVAR patients. The all-cause 1-year mortality showed a favorable trend for TEVAR in the VALOR trial; however, in T2 patients, 1-year all-cause mortality was similar in both groups of patients (17% TEVAR vs 15% OSR; P = .8). Age (P = .01), history of cerebrovascular accident (P < .05), antiarrhythmia medication (P = .04), and renal disease (P < .03) independently predicted all-cause and aneurysm-related mortality by regression analysis.ConclusionsPS analysis is an important tool for elimination of bias inherent when retrospective controls are used. Its application to VALOR validates the long-term benefit in aneurysm-related mortality conferred by TEVAR in patients undergoing endovascular DTA repair
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