ACCF/SCAI/SVMB/SIR/ASITN 2007 Clinical Expert Consensus Document on Carotid Stenting (original) (raw)

Credentialing of surgeons as interventionalists for carotid artery stenting: Experience from the lead-in phase of CREST

Journal of Vascular Surgery, 2004

Background: Credentialing of vascular surgeons to perform carotid artery stenting (CAS) continues to be a major issue confronting the specialty of Vascular Surgery. Cannulation of aortic arch branches, and placement of carotid antiembolic devices and stents constitute the major technical challenges to vascular surgeons becoming credentialed to perform CAS. The multicenter Carotid Revascularization Endarterectomy vs Stenting Trial (CREST), supported by the National Institute of Neurological Disorders and Stroke, National Institute of Health, reviews credentials of interventionalists, including surgeons, for the trial's "lead-in" phase of CAS to treat symptomatic (>50% stenosis) and asymptomatic (>70% stenosis). Methods: Vascular surgeons requesting participation in CREST must have achieved basic interventional credentialing criteria as recommended by the Society of Vascular Surgery. Each interventionalist is asked to submit notes and narrative summaries from a series of 10 to 30 CAS procedures for review by a multi-specialty review committee before being approved to participate in CREST. Thereafter, during the lead-in phase of CREST, each approved interventionalist is asked to perform CAS procedures using the study devices in as many as 20 patients. In this interim report from the CREST lead-phase, the association of specialty of operator (vascular surgeon, neurosurgeon, other specialist) and periprocedural stroke and death rate was examined in patients undergoing CAS. In addition, current enrollment volume in the lead-in phase by specialty of the principal investigator was examined.

A suggested training programme for carotid artery stenting (CAS)

European Journal of Radiology, 2006

Carotid artery stenting as an alternative to traditional carotid endartrectomy is becoming increasingly important in the treatment of transient ischemic attack and stroke. Physicians from several different medical disciplines are interested in treating appropriate patients by this method. Patients are entitled to know what training and experience the surgeon or clinician has before giving consent. This should involve endovascular experience in all systems and experience and knowledge of cerebral angiography and intervention. A multidisciplinary approach and reporting of adverse events is vital for patient safety.

The role of endovascular expertise in carotid artery stenting: results from the ALKK-CAS-Registry in 5,535 patients

Clinical Research in Cardiology, 2012

Purpose Several scientific committees have proposed an accentuation of operator minimal requirements before accreditation for carotid artery stenting is granted. The current study aims to identify potential effects from increasing site experience on periprocedural safety and outcome of carotid artery stenting (CAS). Methods Between 1996 and December 2009, 5,535 procedures have been entered into the prospective, controlled ALKK-CAS-Registry. The total cohort was divided in four subgroups according to the consecutive patient order at each participating center: patients 1-49 (n = 1,485), 50-99 (n = 1,118), 100-199 (n = 1,521) and C200 (n = 1,411). Results The median age of all patients was 71 years; 52.8 % had a symptomatic carotid stenosis. A decline in the rates of in-hospital major stroke (2.1, 1.9, 1.6, 0.9, p for trend 0.014) and of ipsilateral strokes (3.1, 2.4, 2.5, 1.6 %, p for trend 0.019) was substantiated with increasing site experience. This significant trend was preserved in the combined rate of major stroke and death (4.0, 3.2, 3.4, 2.4 %, p for trend 0.034). Apart from CAS experience, improvements in CAS technique, a decreasing number of symptomatic patients and an increasing number of procedures under embolic protection (each p for trend \0.05) might have contributed to these results. Conclusions The results show a gradual reduction of inhospital stroke rates with increasing center experience. Extensive supervision of CAS learners and further promotion of proctorship programs seem to be essential.

Experience matters more than specialty for carotid stenting outcomes

Journal of Vascular Surgery, 2015

The introduction of carotid stenting has led to a rapid rise in the number of vascular specialists performing this procedure. The Carotid Revascularization Endarterectomy vs Stenting Trial (CREST) has shown that carotid stenting can be performed with an equivalent major event rate compared with carotid endarterectomy. However, there is still controversy about the appropriate training and experience required to safely perform this procedure. This observational study examined the performance of carotid stenting with regard to specialty and case volume. Methods: From 2004 to 2011, inpatients diagnosed with carotid stenosis who had a carotid stenting procedure were extracted from the Nationwide Inpatient Sample database. The cohort was separated on the basis of the provider performing the procedure (surgeon vs interventionalist), hospital location, and volume. Surgeons were defined as providers who also performed either a carotid endarterectomy or femoral-popliteal bypass during the same time interval. Primary end points analyzed included stroke, myocardial infarction, and 30-day mortality. Length of stay and hospital costs were also analyzed as secondary outcomes. Results: A total of 20,663 cases of carotid stenting were found; 15,305 (74%) cases were identified to be performed by a "surgeon," whereas 5358 (26%) were done by an "interventionalist." The majority of cases were done at hospitals in urban locations (96.51%) and designated teaching institutions (61.47%). Unadjusted outcomes were similar between surgeons and interventionalists in terms of stroke (4.33% and 4.41%), myocardial infarction (2.10% and 2.13%), and mortality (0.84% and 1.03%) respectively. Qualitatively, volume per 10 cases was shown to decrease the risk of stroke. Adjusted multivariate analysis demonstrated no statistical significance between primary end point outcomes. However, length of stay (2.81 vs 3.08 days) and total charges ($48,087.61 and $51,718.77) were lower for procedures performed by surgeons. Conclusions: Surgeons are performing the majority of carotid stent procedures in the United States. The volume of cases performed by a provider, rather than the provider's specialty, appears to be a stronger predictor of adverse outcomes for carotid stenting. There were, however, significant cost differences between surgeons and interventionalists, which needs to be further evaluated at an institutional level.

An analysis of carotid artery stenting procedures performed in New York and Florida (2005-2006): Procedure indication, stroke rate, and mortality rate are equivalent for vascular surgeons and non-vascular surgeons

Journal of Vascular Surgery, 2009

Objective: Carotid artery stenting (CAS) has emerged as an alternative to carotid endarterectomy (CEA) for the treatment of carotid artery stenosis. Unlike CEA, CAS is performed by a wide variety of specialists including vascular surgeons (VS), interventional cardiologists (IC), and interventional radiologists (IR). This study compares the indications, in-patient mortality rate, and in-patient stroke rate for patients undergoing CAS, according to operator specialty. Methods: The State In-patient Databases from New York and Florida, made available by the Healthcare Cost and Utilization Project, were reviewed by International Classification of Disease (ICD)-9-CM codes to identify all patients treated with CAS for the years 2005 and 2006. This cohort was then stratified according to operator specialty defined by procedures performed by each operator over the years surveyed. Primary endpoints were in-patient death and stroke. Propensity score matching adjusting for indication, demographics, and comorbidities was employed to evaluate the influence of operator type on outcomes. Results: During the study period, 4001 CAS procedures were performed. All primary analyses compared VS (n ‫؍‬ 1350) to non-VS (n ‫؍‬ 2651). Patient characteristics were similar, except VS treated fewer patients with CAD (44.2% vs 50.9%, P < .001) and valvular disease (6.3% vs 8.6%, P ‫؍‬ .01) and more patients with chronic lung disease (19.4% vs 15.9%, P ‫؍‬ .01). Each group performed an equal proportion of CAS for symptomatic disease (8.1% vs 9.0%, P ‫؍‬ .32). Univariate analysis revealed no difference in mortality (0.9% vs 0.5%, P ‫؍‬ .13) or stroke (1.3% vs 1.5%, P ‫؍‬ .73). Propensity score matched analysis also demonstrated no difference in mortality (0.7% vs 0.4%, P ‫؍‬ .48) or stroke (1.1% vs 1.7%, P ‫؍‬ .27). Subgroup analysis comparing VS, IC, and IR showed no significant difference in mortality or stroke, but demonstrated that of the three specialties, IC treated the smallest proportion of symptomatic patients. The proportion of CAS performed by VS differed significantly by state (New York 46%, Florida 19%, P < .01). Conclusion: Despite a paucity of level 1 evidence for CAS in asymptomatic patients and current Centers for Medicare and Medicaid Services (CMS) policy limiting reimbursement for CAS to only high-risk symptomatic patients, VS and non-VS are treating primarily asymptomatic patients. Perioperative rates of stroke and death are equivalent between VS, IC, and IR. Regional variation of operator type is substantial, and despite similar outcomes, <50% of CAS is performed by VS.

Carotid artery stenting: Impact of practitioner specialty and volume on outcomes and resource utilization

Journal of Vascular Surgery, 2009

Objectives: A variety of endovascular specialists perform carotid artery stenting (CAS), but little data exist on outcomes and resource utilization among these specialists. We analyzed differences in outcomes after CAS was performed by radiologists (RAD), cardiologists (CRD), and vascular surgeons (VAS). Methods: Secondary data analysis of the 2005-2006 State Inpatient Databases for New Jersey were analyzed. Patients with elective admission to the hospital who had CAS procedure <2 days after admission were identified. CAS outcomes were analyzed with respect to practitioner specialty and volume, associated complications, and hospital resource utilization. Results: We identified 625 CAS cases. CRD performed 378 (60.5%), VAS, 199 (31.8%); and RAD, 48 (7.7%). The overall stroke rate was 2.72% and by specialty was CRD, 3.17%; VAS, 2.01%, and RAD, 2.08% (P ‫؍‬ .6880). The overall cardiac complication rate was 2.40% (CRD, 2.12%; VAS, 3.02%; RAD, 2.08%; P ‫؍‬ .7899). Renal and pulmonary complications were low (0.64% and 0.32%, respectively). Mean hospital length of stay (LOS) in days was significantly shorter for VAS (1.64 ؎ 1.40) compared with RAD (2.83 ؎ 5.15; P ‫؍‬ .0167) and had the same trend compared with CRD (2.14 ؎ 3.37; P ‫؍‬ .0649). Intensive care unit (ICU) LOS was shorter for VAS (0.52 ؎ 0.97) and CRD (0.30 ؎ 0.71) than for RAD (2.12 ؎ 4.48; P < .0001). The mean total hospital cost was significantly greater for RAD ($20,987 ؎ 26,603)andCRD(26,603) and CRD (26,603)andCRD(18,182 ؎ 16,364)thanforVAS(16,364) than for VAS (16,364)thanforVAS(10,000 ؎ 4947;P‫؍‬.0011andP<.0001,respectively).ICUcostforRAD(4947; P ‫؍‬ .0011 and P < .0001, respectively). ICU cost for RAD (4947;P‫؍‬.0011andP<.0001,respectively).ICUcostforRAD(5963 ؎ 14,551)wasalsomorethanforVAS(14,551) was also more than for VAS (14,551)wasalsomorethanforVAS(864 ؎ 1514;P<.0001)andCRD(1514; P < .0001) and CRD (1514;P<.0001)andCRD(473 ؎ 1561;P<.0001).MedicalsupplycostsweresignificantlygreaterforCRD(1561; P < .0001). Medical supply costs were significantly greater for CRD (1561;P<.0001).MedicalsupplycostsweresignificantlygreaterforCRD(8772 ؎ 9546)thanforVAS(9546) than for VAS (9546)thanforVAS(3354 ؎ 2261;P<.0001)andRAD(2261; P < .0001) and RAD (2261;P<.0001)andRAD(4964 ؎ $2595; P ‫؍‬ .0142). Total hospital cost, LOS, and medical supplies were significantly lower for high-volume practitioners vs low-volume practitioners (P < .0001). Conclusion: Stroke rates after CAS did not vary significantly among practitioner specialties. Hospital resource utilization did vary significantly: Vascular surgeons had the lowest utilization of hospital resources for performing CAS. High practitioner volume was associated with lower hospital resource utilization. Elucidation of factors creating resource utilization disparities among endovascular practitioners may lead to improved patient outcomes and permit significant future cost savings for carotid interventions. ( J Vasc Surg 2009;49:1166-71.)

Why Calls for More Routine Carotid Stenting Are Currently Inappropriate: An International, Multispecialty, Expert Review and Position Statement

Stroke, 2013

should not extend reimbursement indications for carotid artery angioplasty/stenting. A potential crisis looms in the United States of America-related to the proposal for the US Center for Medicare and Medicaid Services (CMS) to allow wider indications for government reimbursement for carotid angioplasty/stenting (CAS). We, the undersigned, are writing to advise CMS to reject this proposal based on overwhelming evidence that it would have serious negative health and economic repercussions for the United States of America and any other country that may follow such inappropriate action. The purpose of this message is not to advise on existing CMS policy. Instead, we wish to advise that current Medicare coverage for CAS should not be extended to routine practice management of asymptomatic carotid stenosis or symptomatic carotid stenosis where the patient is considered at 'low/average risk' of complications from carotid endarterectomy (CEA). We understand that, currently, CMS covers the cost of CAS for the indications listed below (the National Coverage Determination [NCD] for Percutaneous Transluminal Angioplasty [PTA] Dec. 2009): i. Concurrent with carotid stent placement when furnished in accordance with the FDA-approved protocols governing Category B Investigational Device Exemption (IDE) clinical trials. ii. Concurrent with the placement of an FDA-approved carotid stent and an FDA-approved or -cleared embolic protection device for an FDA-approved indication when furnished in accordance with FDA-approved protocols governing post-approval studies.