Clopidogrel resistance is common in patients undergoing vascular and coronary interventions.

OBJECTIVES: "Clopidogrel resistance," also defined as heightened platelet reactivity (HPR) while on clopidogrel therapy, may lead to a sub-optimal antiplatelet effect and a potential thrombotic event. There is limited literature addressing the prevalence of HPR in a large cohort of patients receiving either coronary or endovascular interventions. METHODS: In a large integrated healthcare system, patients with a P2Y12 reaction units (PRU) test were identified. HPR was defined as a PRU ≥ 200 during clopidogrel therapy. Vascular and coronary interventions were identified utilizing CPT codes, HPR prevalence was calculated, and Fischer's exact test was used to determine significance. RESULTS: From an initial cohort of 2,405,957 patients (October 2014 to January 2020), we identified 3301 patients with PRU tests administered. Of these, 1789 tests had a PRU ≥ 200 (HPR overall prevalence, 54%). We then identified 1195 patients who underwent either an endovascular or coronary procedure and had a PRU measurement. This corresponded to 935 coronary and 260 endovascular interventions. In the coronary cohort, the HPR prevalence was 54% (503/935). In the vascular cohort, the HPR prevalence was 53% (137/260); there was no difference between cohorts in HPR prevalence (p = 0.78). CONCLUSION: "Clopidogrel resistance" or HPR was found to be present in nearly half of patients with cardiovascular disease undergoing intervention. Our data suggest HPR is more common in the cardiovascular patient population than previously appreciated. Evaluating patients for HPR is both inexpensive ($25) and rapid (< 10 min). Future randomized studies are warranted to determine whether HPR has a clinically detectable effect on revascularization outcomes.

Clinical Trial Principles and Endpoint Definitions for Paravalvular Leaks in Surgical Prosthesis.

The VARC (Valve Academic Research Consortium) for transcatheter aortic valve replacement set the standard for selecting appropriate clinical endpoints reflecting safety and effectiveness of transcatheter devices, and defining single and composite clinical endpoints for clinical trials. No such standardization exists for circumferentially sutured surgical valve paravalvular leak (PVL) closure. This document seeks to provide core principles, appropriate clinical endpoints, and endpoint definitions to be used in clinical trials of PVL closure devices. The PVL Academic Research Consortium met to review evidence and make recommendations for assessment of disease severity, data collection, and updated endpoint definitions. A 5-class grading scheme to evaluate PVL was developed in concordance with VARC recommendations. Unresolved issues in the field are outlined. The current PVL Academic Research Consortium provides recommendations for assessment of disease severity, data collection, and endpoint definitions. Future research in the field is warranted.

Contemporary risk model for inhospital major bleeding for patients with acute myocardial infarction: The acute coronary treatment and intervention outcomes network (ACTION) registry®-Get With The Guidelines (GWTG)®.

BACKGROUND: Major bleeding is a frequent complication for patients with acute myocardial infarction (AMI) and is associated with significant morbidity and mortality. OBJECTIVE: To develop a contemporary model for inhospital major bleeding that can both support clinical decision-making and serve as a foundation for assessing hospital quality. METHODS: An inhospital major bleeding model was developed using the Acute Coronary Treatment and Intervention Outcomes Network Registry-Get With the Guidelines (ACTION Registry-GWTG) database. Patients hospitalized with AMI between January 1, 2012 and December 31, 2013 across 657 hospitals were used to create a derivation cohort (n=144,800) and a validation cohort (n=96,684). Multivariable hierarchal logistic regression was used to identify significant predictors of major bleeding. A simplified risk score was created to enable prospective risk stratification for clinical care. RESULTS: The rate of major bleeding in the overall population was 7.53%. There were 8 significant, independent factors associated with major bleeding: presentation after cardiac arrest (OR 2.99 [2.77-3.22]); presentation in cardiogenic shock (OR 2.22 [2.05-2.40]); STEMI (OR 1.72 [1.65-1.80]); presentation in heart failure (OR 1.55 [1.47-1.63]); baseline hemoglobin less than 12 g/dL (1.55 [1.48-1.63]); heart rate (per 10 beat per minute increase) (OR 1.13 [1.12-1.14]); weight (per 10 kilogram decrease) (OR 1.12 [1.11-1.14]); creatinine clearance (per 5-mL decrease) (OR 1.07 [1.07-1.08]). The model discriminated well in the derivation (C-statistic = 0.74) and validation (C-statistic = 0.74) cohorts. In the validation cohort, a risk score for major bleeding corresponded well with observed bleeding: very low risk (2.2%), low risk (5.1%), moderate risk (10.1%), high risk (16.3%), and very high risk (25.2%). CONCLUSION: The new ACTION Registry-GWTG inhospital major bleeding risk model and risk score offer a robust, parsimonious, and contemporary risk-adjustment method to support clinical decision-making and enable hospital quality assessment. Strategies to mitigate risk should be developed and tested as a means to lower costs and improve outcomes in an era of alternative payment models.

Systematic review of multiple versus single device closure of Secundum atrial septal defects in adults.

INTRODUCTION: Multiple device closure (MDC) strategy has been used in treating of complex Atrial septal defects (ASDs) in adults. The safety profile of MDC compared to conventional single device closure (SDC) is unknown in this population. This report represents the first review examining the outcomes of single versus multiple device ASD closure in adults with ostium secundum defects. METHODS: Literature databases and manual search from their inception until June 30th, 2017 followed the Preferred Reporting Items of Systemic Review and Meta-Analysis (PRISMA) guideline. Main outcomes are 1) overall complication incidence, 2) arrhythmia incidence, 3) residual shunt rate. Each outcome profile was pooled by MDC and SDC, respectively and chi-square analysis was applied to examine statistical significance between MDC and SDC strategies (two-sided and p < .050). RESULTS: A total of 1806 + studies were initially screened, and 20 studies were finally selected (MDC group, 147 patients; SDC group, 1706 patients). There was no difference in overall complication incidence (χ2 = 1.269; p = .259) and arrhythmia incidence (χ2 = 0.325; p = .568) between MDC and SDC. There was no difference in residual shunt rate between the SDC (4.10 %; 70/1706) and MDC groups (6.80 %; 10/147; χ2 = 2.387; p = .122). CONCLUSIONS: The outcomes of percutaneous multiple ASD closure (MDC) seem to be safe and effective as compared to conventional single ASD (SDC) closure in terms of device - related complications and technical success of the procedure. Prospective registry data and randomized trials are needed to determine the long-term outcomes of percutaneous ASD closure using MDC.

Carotid artery stenting: patient, lesion, and procedural characteristics that increase procedural complications.

From the earliest experiences with carotid artery stenting (CAS) presumptive high risk features have included thrombus-containing lesions, heavily calcified lesions, very tortuous vessels, and near occlusions. In addition patients have been routinely excluded from CAS trials if they have contra-indications to dual antiplatelet therapy (aspirin and thienopyridines), a history of bleeding complications and severe peripheral arterial disease (PAD) making femoral artery vascular access difficult. Variables that increase the risk of CAS complications can be attributed to patient characteristics, anatomic or lesion features, and procedural factors. Clinical features such as older age (≥80 years), decreased cerebral reserve (dementia, multiple prior strokes, or intracranial microangiopathy) and angiographic characteristics such as excessive tortuosity (more than two 90° bends within 5 cm of the target lesion) and heavy calcification (concentric calcification ≥ 3 mm in width) have been associated with increased CAS complications. Other high risk CAS features include those that prolong catheter or guide wire manipulation in the aortic arch, make crossing a carotid stenosis more difficult, decrease the likelihood of successful deployment or retrieval of an embolic protection device (EPD), or make stent delivery or placement more difficult. Procedure volume for the operator and the catheterization laboratory team are critical elements in reducing the risk of the procedure. In this article, we help CAS operators better understand procedure risk to allow more intelligent case selection, further improving the outcomes of this emerging procedure.

Multisociety consensus quality improvement guidelines for intraarterial catheter-directed treatment of acute ischemic stroke, from the American Society of Neuroradiology, Canadian Interventional Radiology Association, Cardiovascular and Interventional Radiological Society of Europe, Society for Cardiovascular Angiography and Interventions, Society of Interventional Radiology, Society of NeuroInterventional Surgery, European Society of Minimally Invasive Neurological Therapy, and Society of Vascular and Interventional Neurology.

PURPOSE: In this international multispecialty document, quality benchmarks for processes of care and clinical outcomes are defined. It is intended that these benchmarks be used in a quality assurance program to assess and improve processes and outcomes in acute stroke revascularization. MATERIALS AND METHODS: Members of the writing group were appointed by the American Society of Neuroradiology, Canadian Interventional Radiology Association, Cardiovascular and Interventional Radiological Society of Europe, Society of Cardiac Angiography and Interventions, Society of Interventional Radiology, Society of NeuroInterventional Surgery, European Society of Minimally Invasive Neurological Therapy, and Society of Vascular and Interventional Neurology. The writing group reviewed the relevant literature from 1986 through February 2012 to create an evidence table summarizing processes and outcomes of care. Performance metrics and thresholds were then created by consensus. The guideline was approved by the sponsoring societies. It is intended that this guideline be fully updated in 3 years. RESULTS: In this international multispecialty document, quality benchmarks for processes of care and clinical outcomes are defined. These include process measures of time to imaging, arterial puncture, and revascularization and measures of clinical outcome up to 90 days. CONCLUSIONS: Quality improvement guidelines are provided for endovascular acute ischemic stroke revascularization procedures.

Multisociety consensus quality improvement guidelines for intraarterial catheter-directed treatment of acute ischemic stroke, from the American Society of Neuroradiology, Canadian Interventional Radiology Association, Cardiovascular and Interventional Radiological Society of Europe, Society for Cardiovascular Angiography and Interventions, Society of Interventional Radiology, Society of NeuroInterventional Surgery, European Society of Minimally Invasive Neurological Therapy, and Society of Vascular and Interventional Neurology.

PURPOSE: In this international multispecialty document, quality benchmarks for processes of care and clinical outcomes are defined. It is intended that these benchmarks be used in a quality assurance program to assess and improve processes and outcomes in acute stroke revascularization. MATERIALS AND METHODS: Members of the writing group were appointed by the American Society of Neuroradiology, Canadian Interventional Radiology Association, Cardiovascular and Interventional Radiological Society of Europe, Society of Cardiac Angiography and Interventions, Society of Interventional Radiology, Society of NeuroInterventional Surgery, European Society of Minimally Invasive Neurological Therapy, and Society of Vascular and Interventional Neurology. The writing group reviewed the relevant literature from 1986 through February 2012 to create an evidence table summarizing processes and outcomes of care. Performance metrics and thresholds were then created by consensus. The guideline was approved by the sponsoring societies. It is intended that this guideline be fully updated in 3 years. RESULTS: In this international multispecialty document, quality benchmarks for processes of care and clinical outcomes are defined. These include process measures of time to imaging, arterial puncture, and revascularization and measures of clinical outcome up to 90 days. CONCLUSIONS: Quality improvement guidelines are provided for endovascular acute ischemic stroke revascularization procedures.

A simple percutaneous technique for hemostasis and closure after transcatheter aortic valve implantation.

Access closure is a key element to successful retrograde percutaneous transfemoral transcatheter aortic valve implantation. It requires large-bore femoral arterial access (18Fr-28Fr) which most operators manage with surgical access and closure under general anesthesia. We report a case example of how, using our center's peripheral interventional experience, we have developed a simple five step technique to achieve hemostasis percutaneously.

A randomized trial of intravenous n-acetylcysteine to prevent contrast induced nephropathy in acute coronary syndromes.

BACKGROUND: Pharmacokinetic data suggests that the intravenous form of n-acetylcysteine (NAC) may be more effective than the oral formulation in preventing contrast induced nephropathy (CIN). NAC owing to its anti-oxidant properties might be beneficial for patients with acute coronary syndromes (ACS) who are at increased risk for CIN. The aim of this prospective randomized, single-center, double-blind, placebo controlled trial (NCT00939913) was to assess the effect of high-dose intravenous NAC on CIN in ACS patients undergoing coronary angiography and/or percutaneous coronary intervention (PCI). METHODS: We randomized 398 ACS patients scheduled for diagnostic angiography ± PCI to an intravenous regimen of high-dose NAC (1,200 mg bolus followed by 200 mg/hr for 24 hr; n = 206) or placebo (n = 192). The primary end-point was incidence of CIN defined as an increase in serum creatinine concentration ≥ 25% above the baseline level within 72 hr of the administration of intravenous contrast. RESULTS: There was no difference found for the primary end point with CIN in 16% of the NAC group and in 13% of the placebo group (p = 0.40). Change in serum cystatin-C, a sensitive marker for renal function, was 0.046 ± 0.204 in the NAC group and 0.002 ± 0.260 in the control group (p = 0.07). CONCLUSION: In ACS patients undergoing angiography ± PCI, high-dose intravenous NAC failed to reduce the incidence of CIN.

Elective percutaneous intervention for intracranial atherosclerotic stenoses by interventional cardiologists.

BACKGROUND: Current "best" medical therapy with anti-platelet and/or anti-thrombotic agents for symptomatic atherosclerotic intracranial (IC) disease is associated with high recurrence. IC catheter-based therapy (CBT) using balloon angioplasty with or without stent placement is an option for patients who have failed medical therapy. We sought to examine the outcomes of CBT for patients with symptomatic IC arterial disease managed by experienced interventional cardiologists. METHODS: We retrospectively studied 89 consecutive symptomatic patients with 99 significant (≥70% diameter) IC arterial stenoses who underwent CBT. CBT was performed by experienced interventional cardiologists with the consultative support of a neurovascular team. The primary endpoint was stroke and vascular death. RESULTS: Procedure success was achieved in 96/99 (97%) lesions and percent diameter stenosis was reduced from 91% ± 7.5% preprocedure to 19% ± 15% postprocedure (P < 0.001). The rate of in-hospital periprocedural stroke and all death was 3%. The primary endpoint of stroke and vascular death rate at 1 year was 5.7% (5/88) and at 2 years was 13.5% (11/81). The 2-year all-cause mortality was 11.3% (10/88). CONCLUSIONS: For patients with symptomatic IC arterial stenosis who have failed medical therapy or are considered very high risk for stroke, CBT performed by experienced interventional cardiologists is safe and offers both high procedural success rates and excellent clinical outcomes at 1 year. CBT is an attractive option for this high-risk patient population considering the expected 12-15% rate of recurrent stroke at 1 year.

Factors related to a clinically silent peri-procedural drop in hemoglobin with coronary and peripheral vascular interventions.

Clinically evident and subclinical peri-procedural bleeding following interventional therapies are associated with adverse cardiovascular outcomes. The risk factors for clinically evident bleeding have been well described. Despite the well-documented association of adverse outcomes for patients with a subclinical peri-procedural hemoglobin drop, the clinical predictors have not yet been defined. We identified 1176 consecutive patients with a subclinical drop in hemoglobin (fall of ≥ 1 g/dl in patients without clinical bleeding) following percutaneous coronary interventions (PCI) and peripheral vascular interventions (PVI). Multivariate logistic regression analysis was performed. A subclinical peri-procedural hemoglobin drop ≥ 1 g/dl was identified in 41% (400/972) of PCI and in 49% (213/435) of PVI. More than one access site predicted a higher risk of a subclinical drop in hemoglobin in both groups. A body mass index ≥ 30 predicted a lower risk of a subclinical drop in hemoglobin in both groups. For PCI, creatinine clearance < 60 ml/min was associated with a higher risk of a subclinical drop in hemoglobin. In conclusion, clinically silent peri-procedural hemoglobin fall ≥ 1 g/dl is common in patients undergoing both coronary and peripheral percutaneous intervention. Predictors identified in our study will need prospective validation.

Catheter-based therapy of common femoral artery atherosclerotic disease.

The objective of this paper is to describe outcomes of endovascular therapy in patients with symptomatic common femoral artery (CFA) lesions. Symptomatic atherosclerotic disease of the common femoral artery is an uncommon clinical entity, and there is no consensus regarding the suitability of catheter-based therapy. We reviewed the records of 26 consecutive patients treated with catheter-based therapy for symptomatic CFA lesions between 1994 and 2009. Angiographic success and procedure success were obtained in all vessels and in all patients. At 1 year, 100% (16/16) of the claudication patients and 70% (7/10) of the critical limb ischemia (CLI) patients maintained clinical success. The ankle- brachial index (ABI) significantly improved from a baseline of 0.47 ± 0.18 to 0.77 ± 0.18 (p < 0.001) after the procedure. At their most recent clinic visit (31 months ± 14 months), clinical success was maintained in 100% of the claudication patients and in 70% (7/10) of the CLI patients. During the follow-up period, femoral vascular access for an unrelated procedure was obtained through the CFA stent. In conclusion, patients with symptomatic CFA atherosclerotic disease obtained excellent clinical outcomes with angioplasty with stenting. We found that angioplasty with stenting of the CFA did not preclude future CFA vascular access. Our data suggest that catheter-based therapies should be considered as an option to open surgery in selected patients with symptomatic CFA disease.

Transaxillary TAVR Leads to Shorter Ventilator Duration and Hospital Length of Stay Compared to Transapical TAVR.

There is an increasing need for alternative access in patients with prohibitive surgical risk who have unsuitable anatomy for transfemoral transcatheter aortic valve replacement (TAVR). Data on differences in periprocedural outcomes via alternative access sites are scarce. We performed a retrospective analysis of patients who underwent Transaxillary (TAX) or Transapical (TAP) TAVR at our center from 2012 to 2019. All data was summarized and displayed as mean ± SD for continuous variables and number of patients in each group. A propensity score was created for each patient in the dataset to determine the probability of axillary vs apical access. We adjusted for propensity score using multivariate logistic regression. A total of 102 patients underwent TAVR via alternative access: 28 patients (27%) via TAX and 74 patients (73%) via transapical (TAP) access. The average time to extubation in the TAX group was 5.3 ± 3.5 hours vs 9.1 ± 8.8 hours in the TAP patients (P = 0.03). None of the TAX patients required reintubation compared to 23% of TAP TAVR (P = 0.003). The average hospital length of stay for TAX was 2.4 ± 2.0 days compared to 6.9 ± 3.3 days (P < 0.0001) for TAP. TAX TAVR patients had significantly lower re-intubation rates, shorter time to extubation and in-hospital length of stay, but higher pacemaker implantation rates. TAX TAVR had improved periprocedural outcomes compared to TAP TAVR and remains the preferred TAVR alternative access.

Epidemiology, evaluation, and management of conduction disturbances after transcatheter aortic valve replacement.

Aortic stenosis is the most common valvulopathy requiring replacement by means of the surgical or transcatheter approach. Transcatheter aortic valve replacement (TAVR) has quickly become a viable and often preferred treatment strategy compared to surgical aortic valve replacement. However, transcatheter heart valve system deployment not infrequently injures the specialized electrical system of the heart, leading to new conduction disorders including high-grade atrioventricular block and complete heart block (CHB) necessitating permanent pacemaker implantation (PPI), which may lead to deleterious effects on cardiac function and patient outcomes. Additional conduction disturbances (e.g., new-onset persistent left bundle branch block, PR/QRS prolongation, and transient CHB) currently lack clearly defined management algorithms leading to variable strategies among institutions. This article outlines the current understanding of the pathophysiology, patient and procedural risk factors, means for further risk stratification and monitoring of patients without a clear indication for PPI, our institutional approach, and future directions in the management and evaluation of post-TAVR conduction disturbances.

Standardized definitions and clinical endpoints in carotid artery and supra-aortic trunk revascularization trials.

BACKGROUND: Endovascular therapy has emerged as a promising alternative to open surgery for stroke prevention in patients with obstructive disease of the supra-aortic arteries. Although most previous studies have used similar safety and efficacy endpoints, differences in definitions, timing of assessments, and standards of reporting have hampered direct comparisons across various trials. METHODS AND RESULTS: The DEFINE group, an informal collaboration of multidisciplinary physicians, involved in the therapy of patients with obstructive disease of the supra-aortic arteries in Europe and the United States reviewed the current literature and, after extensive correspondence and meetings, proposed the definitions outlined in the present manuscript. Three meetings including all authors of the manuscript, along with representatives of the United States Food and Drug Administration (FDA) and commercial device manufacturers were held in Barcelona, Spain, in May 2008, in Munich, Germany, in July 2008, and in New York in November 2008. The proposed definitions encompass baseline clinical and anatomic characteristics, clinical and radiologic outcomes, complications, standards of reporting, and timing of assessment. CONCLUSIONS: Considering the broad consensus between the multidisciplinary scientific members and the regulatory authorities, the proposed definitions are expected to find adoption in future clinical investigations. These definitions can be applied to both endovascular and open surgery trials and will allow reliable comparisons between these two revascularization methods.

Elective Percutaneous Paravalvular Leak Closure Under Conscious Sedation: Procedural Techniques and Clinical Outcomes.

BACKGROUND: Paravalvular leaks (PVLs) are a well-recognized complication of prosthetic valves that are detected up to 18% of all implanted surgical valves. Perioperative morbidity is thought to be lower in percutaneous compared to surgical PVL repair. However, a direct comparison of PVL closure techniques has never been performed. Our study is the first to demonstrate that elective PVL closure with monitored anesthesia care can be achieved with high success and low complications rates resulting in short hospital stays. METHODS: This is a retrospective cohort of patients admitted electively for catheter-based treatment of symptomatic prosthetic paravalvular regurgitation from Jan 2013 to April 2018. Both mitral and aortic PVLs were included. Patients' demographics, risk factors, procedural outcomes, In-hospital and thirty-day mortality were all reported. We followed the Valve Academic Research Consortium (VARC) criteria to define device and procedural technical success. In-hospital and 30- day outcomes were assessed by retrospective chart review. RESULTS: A total of 54 PVLs in thirty-seven patients were repaired (65% aortic & 35% mitral). The mean-age in the mitral cohort was lower than the aortic cohort (61 vs 72years, P<0.0001) but the two groups shared similar clinical risk factors (P>0.05). Average hospital stay was 1-2days (<1.5days overall cohort) which was significantly lower in the aortic compared to the mitral cohort (P=0.009). All procedures were guided by TEE under conscious sedation with monitored anesthesia care. Procedural technical success defined as any significant residual shunt was 81% in the overall cohort and 88% in the aortic group. No procedural deaths were reported. Short-term mortality during the first 30days was 5.4% (two patients). CONCLUSION: Elective catheter-based repair of symptomatic prosthetic paravalvular regurgitation appears to be safe and effective. The use of conscious sedation with monitored anesthesia care resulted in short hospital stay.

Low risk TAVR: Long- term considerations and appropriate patient selection.

Recent trials have shown impressive results in low-risk patients undergoing Transcatheter Aortic Valve Replacement (TAVR) with low procedural complication rates, short hospital length of stay, zero mortality, and zero disabling stroke at 30 days and have led to a Food and Drug Administration indication for TAVR in these patients. The long-term data on subclinical leaflet thrombosis, valve durability, effects of pacemaker implantation, right ventricular pacing, and progressive paravalvular leak is unclear. We describe clinical and procedural considerations for patient selection and introduce future potential procedural challenges. Finally, we discuss the importance of considering life expectancy and durability prior to TAVR in this low risk relatively young cohort and emphasize the importance of a heart team approach.

Acute stroke intervention by interventional cardiologists.

OBJECTIVES: To report the technical success and clinical outcomes of catheter-based therapy (CBT) for acute ischemic stroke in patients ineligible for intravenous thrombolysis. BACKGROUND: Acute ischemic stroke is common but undertreated. CBT for acute ischemic stroke is a therapeutic option in selected patients who are not candidates for intravenous thrombolysis. METHODS: Consecutive stroke patients who were ineligible for intravenous thrombolysis and underwent CBT were identified by retrospective chart review. Demographic information, National Institutes of Health Stroke Scale (NIHSS), procedural characteristics, and clinical outcomes during hospitalization and at 90 days follow up were collected. Experienced interventional cardiologists with the consultative support of stroke neurologists were on call for acute strokes. RESULTS: A total of 33 acute ischemic stroke patients underwent emergency cerebral angiography, with 26 patients undergoing CBT. Successful "culprit" artery recanalization was achieved in 23 (88%) of the 26 patients. In-hospital adverse events occurred in 4 (15%) patients, with intracerebral hemorrhage (ICH) (12%) representing the most common adverse event. The baseline NIHSS for patients who underwent intervention was 16.5 +/- 9.9 (median 16) and improved significantly to 9.9 +/- 8.7 (median 9) (P < 0.001) at hospital discharge. A modified Rankin score of two or less (indicating mild disability) was achieved in half (n = 13) of the CBT treated patients. All cause mortality at 90 days was 8% (2/26). CONCLUSIONS: In selected patients, CBT provided by qualified interventional cardiologists supported by stroke neurologists, offers a safe and effective option for patients with acute stroke who are not eligible for intravenous thrombolysis.

Catheter-based treatment of the subclavian and innominate arteries.

OBJECTIVES: We report outcomes in patients undergoing catheter-based intervention for symptomatic subclavian and innominate artery (S/IA) atherosclerosis. BACKGROUND: Symptomatic S/IA obstructive lesions have traditionally been treated with open surgical revascularization. Catheter-based endovascular therapies reduce the morbidity and mortality associated with surgery in many vascular beds. METHODS: Between December 1993 and May 2006, 170 patients underwent primary stent placement in 177 S/IA arteries. Indications for revascularization included arm ischemia (57%), subclavian steal syndrome (37%), coronary-subclavian steal syndrome (21%), and planned coronary bypass surgery with the involved internal mammary artery (8%). RESULTS: Technical success was achieved in 98.3% (174/177) arteries, including 99.4% for stenotic lesions (155/156) and 90.5% for occlusions (19/21). There were no procedure-related deaths and one stroke (0.6%, 1/170). Follow-up was obtained in 151 (89%) patients at 35.2 +/- 30.8 months, with a target vessel revascularization rate of 14.6% (23/157). At last follow-up, 82% (124/151) of all treated patients remained asymptomatic with a primary patency of 83% and a secondary patency of 96%. CONCLUSIONS: Catheter-based revascularization with stents for symptomatic S/IA lesions is safe and effective with excellent patency rates and sustained symptom resolution in the majority (>80%) of patients over 3 years of follow-up. Percutaneous primary stent therapy is the preferred method of revascularization in patients with suitable anatomy.