Biomedical subjects
Publications and source records attributed to Robert D Safian.
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OBJECTIVES: The purpose of this study was to determine the safety of carotid artery stenting with a unique distal embolic protection system in high-risk patients with severe carotid stenosis. BACKGROUND: Previous studies suggest that some patients with carotid stenosis and serious comorbid conditions are at high risk for carotid endarterectomy, and may be safely treated by carotid artery stenting. METHODS: A prospective non-randomized multicenter registry of 419 patients with severe carotid stenosis and high-risk features for carotid endarterectomy was conducted between April 2004 and October 2004. Carotid artery stenting was performed with the Protégé Self-Expanding Nitinol Stent and the SPIDER Embolic Protection System (ev3 Inc., Plymouth, Minnesota). Aspirin and clopidogrel were prescribed at least 24 h before and three months after revascularization. The primary outcome was the combined incidence of major adverse cardiac and cerebrovascular events at 30 days after intervention, including death, stroke, and myocardial infarction. A secondary outcome was the technical success, defined as successful deployment of all devices, filter retrieval, and final diameter stenosis <50%. RESULTS: Technical success was achieved in 408 of 419 patients (97.4%). The primary end point was observed in 26 patients (6.2%), including death in 8 (1.9%), nonfatal stroke in 14 (3.3%), and nonfatal myocardial infarction in 4 (1%). Independent predictors of death or stroke at 30 days included duration of filter deployment, symptomatic carotid stenosis, and baseline renal insufficiency. CONCLUSIONS: For some patients with severe carotid stenosis and high-risk features for carotid endarterectomy, carotid artery stenting with distal embolic protection is a reasonable alternative for revascularization.
This report describes the use of a percutaneous ex-vivo femoral arterial bypass in three patients with acute lower extremity ischemia that occurred as a complication of femoral artery catheterization. Utilizing standard equipment and techniques, a percutaneous ex-vivo femoral artery bypass can restore antegrade flow to the ischemic limb in patients with impaired aorto-iliac inflow circulation, which may arise from iatrogenic dissection or the need for large in-dwelling sheaths required for hemodynamic support. This technique is considered a temporizing measure when conventional therapies are not possible. Contrast angiography is recommended to localize and define the cause of limb ischemia, and to permit safe placement of vascular sheaths in the "donor and recipient" arteries.
Our objective was to evaluate the safety of percutaneous transfemoral catheterization performed by way of synthetic aortofemoral vascular grafts. Between 1994 and 2003, 123 catheterization procedures were performed using a synthetic aortofemoral graft (median graft age 2.5 years, range 4 days to 10.3 years), including 63 (51%) interventional and 60 (49%) diagnostic procedures. Adverse events related to vascular access occurred in 7 of 123 procedures (5.7%), including blood transfusion (4.1%), thrombotic occlusion (1.6%), transient limb ischemia (0.8%), and retroperitoneal hemorrhage (0.8%). No deaths, graft infections, or pseudoaneurysms occurred.
Although there has been enthusiasm for using embolic protection devices in acute myocardial infarction, it is unclear how often these devices can be used in nonselected patients. The aim of this study was to evaluate potential eligibility for use of either proximal or distal embolic protection during primary or rescue percutaneous coronary intervention in a consecutive, nonselected population. We analyzed the angiograms of 259 consecutive patients with ST-segment elevation myocardial infarction to determine eligibility for use of either type of protection device. Overall, 202 (78%) patients had anatomy suitable for embolic protection, including 154 (59%) who were eligible for proximal protection, 128 (49%) who were eligible for distal protection, and 80 (31%) who were eligible for both devices. Patients eligible for proximal protection were more likely to have a right coronary culprit, whereas patients eligible for distal protection were more likely to have a lesion in the left anterior descending coronary artery.
Distal embolic protection devices have been shown to reduce the risk of peri-procedural complications associated with saphenous vein graft intervention. However, there are several important anatomic limitations that may preclude routine device use. We analyzed the angiograms of 624 consecutive saphenous vein graft interventions to determine eligibility for use of a proximal or distal embolic protection system. Overall, 483 (77%) of cases had anatomic and lesion characteristics suitable for an embolic protection device, including 59% eligible for proximal protection and 57% for distal protection.
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A 90-year-old male presented with symptomatic severe stenosis of an anomalous left carotid artery originating from the brachicephalic trunk. A previous attempt at selective cannulation of the left carotid artery was unsuccessful using a transfemoral approach. We performed successful carotid artery angioplasty and stenting using a right radial artery approach.
Intracoronary brachytherapy is an effective method for treating in-stent restenosis. We report a case of coronary artery pseudoaneurysm after balloon angioplasty and intracoronary beta-radiation. The pseudoaneurysm was treated successfully with implantation of two coronary stent grafts.
The purpose of this study was to evaluate the feasibility of carotid artery revascularization using a new system for carotid stenting and distal embolic protection in 30 patients with severe carotid stenosis and high risk for carotid endarterectomy (Carotid Revascularization With ev3 Arterial Technology Evolution, or CREATE). Previous studies suggest that patients with carotid stenosis and serious comorbid cardiopulmonary and anatomic conditions are at high risk for carotid endarterectomy. All patients underwent percutaneous revascularization using the Protégé GPS self-expanding nitinol stent (ev3, Plymouth, MN) and the Spider distal embolic protection system (ev3). In-hospital and 30-day outcomes were analyzed. High-risk features included age > 75 years (63%), left ventricular ejection fraction < 35% (20%), and restenosis after prior carotid endarterectomy (53%). Procedural success was 100%. In-hospital complications included severe vasovagal reactions in six patients (20%) and a popliteal embolus in one patient (3.3%), treated by successful embolectomy. During 30 days of follow-up, two patients (6.6%) experienced minor neurological deficits, including transient expressive aphasia that resolved without therapy in one patient and homonymous hemianopsia due to contralateral posterior circulation stroke in one patient. This study supports the feasibility of percutaneous carotid artery revascularization with the Protégé GPS self-expanding stent and Spider distal embolic protection system, which will be evaluated in a large multicenter pivotal trial (CREATE Pivotal Trial).
OBJECTIVES: We sought to develop a simplified scoring system based on pre-intervention clinical characteristics to predict in-hospital mortality after percutaneous coronary intervention (PCI). BACKGROUND: Percutaneous coronary intervention is associated with variety of complications, including the risk of death. Factors leading to poor outcomes need to be identified. Currently available indexes are cumbersome and therefore seldom used. METHODS: Crude mortality and univariate odds ratios (ORs) for mortality associated with multiple clinical characteristics were calculated for 9,954 patients undergoing PCI at the William Beaumont Hospital during 1996 to 1998. Based on the OR, each factor was assigned a weighted score. Using these scores, a classification was constructed to determine the probability of death after PCI, with classes I through IV representing an increasing probability of procedural mortality. This classification was validated in a separate group of patients. RESULTS: The factors with the highest univariate odds of dying and their scores were: myocardial infarction <14 days = 7; elevated creatinine = 4; multivessel disease = 4; and age >65 years = 3. Classes were created based on the presence of these factors in a given patient. The odds of dying and mortality increased significantly with each class. These results were reproduced in the validation subset. CONCLUSIONS: Preprocedural clinical risk factors have a differential influence on the probability of death after PCI. Risk classification based on these factors can be used to accurately predict the procedural outcome. This simple classification can be used by interventionalists to assist in management decisions, to provide an estimate of procedural risk to the patients and relatives, and for quality assurance.
Cardiac tamponade is an uncommon but life-threatening complication of percutaneous coronary intervention (PCI). The purpose of the present study was to characterize the incidence, management, and clinical outcome associated with this complication. We analyzed a prospective database of 25,697 PCIs performed at William Beaumont Hospital (Royal Oak, Michigan) between October 1993 and December 2000. Cardiac tamponade was observed in 31 of 25,697 PCI procedures (0.12%). Cardiac tamponade was diagnosed in the catheterization laboratory in 17 of 31 patients (55%), and 14 patients (45%) had a delayed presentation (mean time from PCI 4.4 hours). Cardiac tamponade was twice as frequent after use of atheroablative devices compared with percutaneous transluminal coronary angioplasty and stenting (0.26% vs 0.11%, p <0.05). All patients with immediate cardiac tamponade had coronary artery perforation. In 11 of 14 patients with delayed tamponade (79%), no actual site of perforation could be identified. A moderate or large pericardial effusion was observed in 20 patients, and 9 had small effusions without typical echocardiographic features of tamponade. Pericardiocentesis was performed in 30 patients; 19 patients (61%) were treated successfully with aspiration alone, but 12 patients (39%) required further emergency surgical intervention. In-hospital complications included death (42%), emergency surgery (39%), myocardial infarction (29%), and transfusion (65%). Cardiac tamponade is an uncommon but important complication of PCI and is associated with high mortality and morbidity. Most cases are recognized in the catheterization laboratory, but delayed cardiac tamponade may occur and must be considered as a cause of late hypotension after PCI.
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Our understanding of plaque instability may be extended to vein graft atherosclerosis, which appears to represent the end of a continuum of plaque instability. Compared with plaque in native coronary arteries, vein graft atheroma is more diffuse and vulnerable to rupture, and the consequences of plaque rupture in vein grafts seem to be associated with almost certain thrombotic occlusion within 7 to 12 years after surgery.