Cath Lab Digest

Abstract

Background. Carotid artery stenting (CAS) is evolving as a less invasive alternative to carotid endarterectomy (CEA) to treat patients with carotid artery stenosis at high surgical risk. However, little is known about the quality and safety of CAS in a relatively low volume, community hospital setting, especially when used as an alternative to CEA for high-risk surgical candidates. Objective. To analyze outcomes of CAS performed in a low-volume community hospital setting. Methods. This was a retrospective, observational study of outcomes in 81 consecutive high surgical risk patients treated with self-expandable carotid stent system with embolic protection device in Newark Beth Israel Medical Center (NBIMC) from March 2004 to December 2008. The endpoints were: procedural success; 30-day composite rate of stroke, death or myocardial infarction (MI); 1-year composite rate of ipsilateral stroke, death or MI; 1-year rate of restenosis. Results. Procedural success was achieved in 98% of the entire cohort. Composite 30-day incidence of stroke, death or MI occurred in 7.4% of patients, primarily due to stroke (4.9%) with statistically significant (20% vs 3.3%, p=0.03) decrease in the occurrence of adverse events as compared in the very first 20 patients (group 1) and the subsequent 61 patients (group 2) to demonstrate a “learning curve” phenomenon. Conclusions. CAS is an effective procedure with high procedural success in the setting of  a relatively small volume center. The overall adverse event rate after CAS was comparable to data presented in published CAS trials and registries. After a clear-cut “learning curve,” extending beyond experience required by present credentialing process, the results were dramatically improved and competitive.

VASCULAR DISEASE MANAGEMENT 2011;8:E126–E131

Introduction

Carotid artery stenting (CAS) as an alternative to carotid endarterectomy (CEA) evolved and peaked following publication of the results of Stenting and Angioplasty with Protection in Patients at High Risk for Endarterectomy (SAPPHIRE) trial.¹ The SAPPHIRE trial favored CAS with distal embolic protection compared to CEA in high-risk patients with severe carotid stenosis and coexisting medical conditions. CAS then expanded to off-label use in patients with average surgical risk. However, this trend significantly slowed after publication of the results of 2 European trials, EVA-3S² and SPACE,³ which failed to demonstrate non-inferiority of CAS compared to CEA in patients with low to average surgical risk.

Pending the results from the American-based Carotid Revascularization Endarterectomy versus Stenting Trial (CREST), and the International Carotid Stenting Study (ICSS) comparing CAS and CEA in patients with average surgical risk, and because there is a substantial group of high-risk patients, who either refuse CEA or are turned down for CEA by vascular surgeons, our institution decided to pursue a protocol-based CAS team approach. The purpose of our study was to analyze outcomes of CAS performed by a team of an interventional cardiologist and a vascular surgeon in real-world, high-risk surgical patients, treated in a community hospital with a high volume of coronary and non-carotid peripheral interventions.

Methods

This was a retrospective observational study of outcomes in consecutive high-risk surgical carotid artery stenosis patients (SAPPHIRE criteria) treated with self-expanding carotid stent system and distal embolic protection device at our institution from March 2004 to December 2008. Eligible patients with carotid artery disease met general FDA recommendations of high surgical risk based on specific anatomic and comorbid clinical criteria (Table 1), and were considered for CAS by both a very experienced vascular surgeon and an interventional cardiologist. Our institutional review board approved the study.

Early CAS procedures were performed by 2 operators (1 interventional cardiologist as primary operator with a credentialed vascular surgeon as a secondary operator), both credentialed according to an existing protocol after performing the required number of supervised interventions: both operators had more than 15 years of experience in non-carotid peripheral interventions, including supra-arch interventions. Each operator performed more than 50 cerebral angiograms and more than 10 carotid stenting procedures prior to starting the program in our hospital. Each was credentialed according to in-hospital protocol in accordance with the American College of Cardiology (ACC), the American College of Physicians (ACP), the Society for Cardiovascular Angiography and Interventions (SCAI), the Society for Vascular Medicine and Biology (SVMB), and the Society for Vascular Surgery (SVS) clinical competence statement.⁴

All patients were pretreated with aspirin 325 mg and clopidogrel 300 mg, unless they were already on both medications. All patients received intraprocedural heparin to maintain an activated clotting time of 250 to 300 seconds. Frequent neurological examinations were performed during the procedures. Aspirin was continued indefinitely, while clopidogrel was stopped after 1 month, unless patients had other indications for dual antiplatelet therapy.