Patrice Bergeron

Global experience in cervical carotid artery stent placement

The purpose of this article is to review and update the current status of carotid artery stent placement in the world. Surveys to major interventional centers in Europe, North and South America, and Asia were initially completed in June 1997. Subsequent information from these 24 centers in addition to 12 new centers has been obtained to update the information. The survey asked the various questions regarding the patients enrolled, procedure techniques, and results of carotid stenting, including complications and restenosis. The total number of endovascular carotid stent procedures that have been performed worldwide to date included 5,210 procedures involving 4,757 patients. There was a technical success of 98.4% with 5,129 carotid arteries treated. Complications that occurred during the carotid stent placement or within a 30‐day period following placement were recorded. Overall, there were 134 transient ischemic attacks (TIAs) for a rate of 2.82%. Based on the total patient population, there were 129 minor strokes with a rate of occurrence of 2.72%. The total number of major strokes was 71 for a rate of 1.49%. There were 41 deaths within a 30‐day postprocedure period resulting in a mortality rate of 0.86%. The combined minor and major strokes and procedure‐related death rate was 5.07%. Restenosis rates of carotid stenting have been 1.99% and 3.46% at 6 and 12 months, respectively. The rate of neurologic events after stent placement has been 1.42% at 6–12‐month follow‐up. Endovascular stent treatment of carotid artery atherosclerotic disease is growing as an alternative for vascular surgery, especially for patients that are high risk for standard carotid endarterectomy. The periprocedure risks for major and minor strokes and death are generally acceptable at this early stage of development and have not changed significantly since the first survey results. Cathet. Cardiovasc. Intervent. 50:160–167, 2000. ©2000 Wiley–Liss,Inc.

Current global status of carotid artery stent placement.

Our purpose was to review the current status of carotid artery stent placement throughout the world. Surveys were sent to major interventional centers in Europe, North and South America, and Asia. Information from peer-reviewed journals was also included and supplemented the survey. The survey asked various questions regarding the patients enrolled, procedure techniques, and results of carotid stenting, including complications and restenosis. Of the centers which were sent surveys, 24 responded. The total number of endovascular carotid stent procedures that have been performed worldwide to date included 2,048 cases, with a technical success of 98.6%. Complications that occurred during carotid stent placement or within a 30-day period following placement were recorded. Overall, there were 63 minor strokes, with a rate of occurrence of 3.08%. The total number of major strokes was 27, for a rate of 1.32%. There were 28 deaths within a 30-day postprocedure period, resulting in a mortality rate of 1.37%. Restenosis rates of carotid stenting have been 4.80% at 6 mo. Endovascular stent treatment of carotid artery atherosclerotic disease is growing as an alternative to vascular surgery, especially for patients that are at high risk for standard carotid endarterectomy. The periprocedural risks for major and minor strokes and death are generally acceptable at this early stage of development.

First-generation aortic endografts: analysis of explanted Stentor devices from the EUROSTAR Registry.

Purpose: To examine the structure and healing characteristics of chronically implanted Stentor endografts that were explanted due to migration, endoleak, thrombosis, or aneurysm expansion. Methods: The devices were harvested following reoperation (n = 5) or autopsy (n = 1) with implantation times ranging from 13 to 53 months. Structural modifications to the metal components were examined using radiography, endoscopy, and magnetic resonance imaging (MRI). Specimens taken from components of the modular stent-grafts were examined histologically and with scanning electron microscopy (SEM) to assess healing behavior. Physical and chemical stability of the nitinol wires and woven polyester graft material was evaluated using SEM and electron spectroscopy for chemical analysis. Results: Although the endografts were retrieved for a variety of reasons, they exhibited similar healing and structural modifications. The woven polyester sleeve showed evidence of yarn shifting and distortion, yarn damage, and filament breakage leading to the formation of openings in the fabric. The luminal surface endografts showed incomplete healing characterized by a poorly organized, nonadherent thrombotic matrix of variable thickness. Radiographic and endoscopic observations indicated that structural failure of the grafts, particularly in the main aortic component, was related to severe compaction and dislocation of the metallic frame due to suture breaks. Corrosion marks were observed on some nitinol wires in all devices. Chemical analysis and ion bombardment of the nitinol wires revealed that the surface concentrations of titanium and nickel were not homogenous. The first layer was composed of carbon or organic elements, followed by a stratum of highly oxidized titanium with a low nickel concentration; the titanium-nickel alloy lay beneath these layers. Conclusions: Although the materials selected for construction of endovascular grafts appears judicious, the assembly of these biomaterials into various interrelated structures within the device requires further improvement.

Percutaneous Stenting of the Internal Carotid Artery: The European CAST I Study

Purpose: To report the results of a multicenter safety trial of percutaneous carotid stenting performed by vascular surgeons. Methods: Symptomatic or asymptomatic patients ≥ 65 years of age with internal carotid artery (ICA) stenoses ≥ 70% and ≤ 2-cm long were eligible for enrollment. The procedures were performed in an operating room with the choice of anesthesia and the percutaneous access site at the discretion of the surgeon. Only Palmaz stents were used. Results: From January 1, 1996 to December 31, 1997, 99 patients (74 men, mean age 70 years, range 51 to 94) were enrolled in the study. More than half (57 of 99 patients) were asymptomatic. The direct cervical approach was used predominantly (97%). Three (3%) cases were converted to surgery for inability to access the artery or deploy the stent (technical success 97%). No perioperative death or myocardial infarction was reported. Six (6%) procedural complications included 1 reversible arterial spasm, 2 dissections, 1 cervical hematoma, and 2 residual stenoses. One neurological event reversed within 7 days(1% minor stroke rate) and 4 (4%) transient ischemic attacks resolved within 24 hours. One (1%) asymptomatic early occlusion occurred 2 days postoperatively. No neurological event was observed in the 1- to 24-month follow-up (mean 13 months). Two (2%) patients died of nonprocedurally related causes. No stent compression was seen, but 1 asymptomatic occlusion and 3 asymptomatic, non-flow-limiting restenoses (2 < 40%, 1 at 60%) were found within 1 year (3% restenosis rate on an intention-to-treat basis). Patency was 98% at 1 year. Conclusions: The results of this trial support the contention that carotid stenting of short ICA lesions can be performed with a low neurological complication rate.

Recurrent Carotid Disease: Will Stents Be an Alternative to Surgery?

Purpose: To report the results of balloon angioplasty in recurrent carotid occlusive disease and evaluate the potential for stent implantation. Methods and Results: Between April 1991 and September 1995, 15 patients with carotid restenosis underwent 17 endoluminal procedures in 3 common carotid and 14 internal carotid arteries. Two postdilation complications (dissection and acute occlusion) required prompt stenting; one common carotid artery was stented for postdilation residual stenosis. One recurrent lesion was also stented 6 months after initial angioplasty. One stroke, 1 silent cerebral infarction, and 3 transient ischemic attacks occurred in the balloon angioplasty patients (33% neurological complication rate). The common carotid stent patient died 3 days postoperatively due to hyperperfusion syndrome. Long-term follow-up in two stent patients showed no restenosis at 18 and 48 months, respectively. The 11 balloon angioplasty patients likewise have not demonstrated restenosis. Conclusions: Balloon angioplasty alone appears too risky for treating recurrent carotid disease. Stents may offer a safer alternative, particularly when implanted primarily.

Long-term Results with the Palmaz Stent in the Superficial Femoral Artery

Purpose: Femoral stenting has demonstrated inconsistent and often disappointing long-term results. To compare our experience, we retrospectively analyzed a series of patients who had Palmaz balloon-expandable stents placed exclusively for superficial femoral artery (SFA) lesions. Methods: From January 1990 to November 1993, 39 patients were evaluated for claudication (79%) or critical ischemia in 42 limbs. The culprit lesions were confined to the SFA: 24 (57%) occlusions and 18 (43%) stenoses, including 3 restenotic lesions. Stenting was elective in 12 (29%) cases: the 3 restenoses and 9 chronic, calcified occlusions. The remaining stents were applied for postangioplasty residual stenosis or angioscopic findings of thrombogenic luminal irregularities. A total of 55 prostheses were successfully implanted. All patients were maintained on ticlopidine and followed by routine duplex scanning. Follow-up angiography was performed in 28 (72%) patients between 4 and 45 months. Results: In the postprocedural period, two acute thromboses (4.8%) occurred within 48 hours in patients who had long occlusions and poor runoff; no other major complications were encountered, for a clinical success rate of 95%. Follow-up evaluation ranged from 4 months to 4 years with a mean of 25 months. The restenosis rate was 19% (34% in occlusions; 10% in stenotic lesions, p = NS). At 24 months, cumulative primary patency was 77% and secondary patency 89%. Conclusions: Palmaz stents performed well in the SFA, demonstrating a low acute thrombosis rate and good long-term patency. The incidence of restenosis is likely to be greater in occlusions than in stenoses.

Carotid angioplasty and stenting: will periprocedural transcranial Doppler monitoring be important?

PURPOSE To explore the value of transcranial Doppler (TCD) ultrasonography in the periprocedural monitoring of patients undergoing angioplasty procedures for stenosis of the internal carotid artery. METHODS Thirty-two patients were included in the study between April 1991 and September 1995 (6 females, 26 males; average age 66 years). All patients were interrogated before and after angioplasty by a standard TCD examination protocol. Intraprocedurally, TCD was used continuously to monitor cerebral blood flow and supply evidence of embolic particulates. Nineteen patients were treated by percutaneous transluminal angioplasty (PTA) alone; the other 13 underwent primary stent (PS) implantation. RESULTS High-intensity transient signals indicative of emboli appeared to be more frequent in the PTA group than in the PS cohort. Preoperative TCD identified 3 (9%) high-risk patients with incompetent collateral pathways through the circle of Willis. Intraoperatively, TCD detected two postdilation carotid occlusions, a sylvian embolism, and one case of arterial spasm. The preprocedural TCD in a patient with contralateral carotid occlusion showed good collateral circulation, providing reassurance during conversion to endarterectomy when an undeployed stent obstructed blood flow. Postoperatively, TCD confirmed restored intracerebral circulation and identified one hyperperfusion syndrome. CONCLUSIONS TCD is a simple, relatively inexpensive examination that can preprocedurally identify carotid stenosis patients at high risk for intraoperative cerebral ischemia in whom PTA might be preferable to surgery. During the procedure, TCD can document the benefits of endovascular treatment and offer early detection of ischemic complications.

Secondary Aortoduodenal Fistulas: Value of Initial Axillofemoral Bypass

Between January 1970 and April 1989, 20 patients underwent operation for secondary aortoduodenal fistulas. When the preoperative diagnosis was certain and emergency control of bleeding not required, initial axillofemoral bypass was performed before ablation of the infected aortic prosthetic graft during the same operation. When diagnosis was uncertain or severity of bleeding required emergency laparotomy, the therapeutic plan varied over time. Until 1980, we performed either a direct repair (three cases) or the ablation of the aortic graft followed by secondary axillofemoral bypass (four cases). After 1980, the order of procedures was 1) control of bleeding whenever necessary, 2) axillofemoral bypass, and 3) ablation of the aortic graft. Postoperative mortality was two of 13 in patients undergoing initial axillofemoral bypass, compared with six of seven patients undergoing direct surgery or initial ablation of the aortic graft. Of the 12 patients surviving the postoperative period, three died of aortic stump hemorrhage, four, 12, and 14 months after operation. Two patients had a new aortic graft inserted. Repeat replacement of the abdominal aorta graft was performed in one case and ascending thoracic aortobifemoral bypass in the other because of secondary thrombosis of the axillofemoral bypass. We conclude that initial axillofemoral bypass before dealing with the aortic graft improves the immediate prognosis in operations for secondary aortoduodenal fistulas. This procedure does not, however, preclude the possibility of aortic stump infection which can lead to recurrent aortoduodenal fistula. The risk of infection or secondary occlusion of axillofemoral bypass is minimal. Secondary prosthetic replacement is not systematically necessary.

Evaluation of endovascular abdominal aortic aneurysm repair: anatomical classification, procedural success, clinical assessment, and data collection.

Purpose: To detail a methodology for evaluation of endovascular abdominal aortic aneurysm (AAA) repair that has been achieved through consensus of an international multidisciplinary team of investigators. Methods: This schema features an anatomical classification for AAAs, a definition of procedural success, and a procedure for clinical assessment, as well as the necessary data collection forms. Patient data include demographics, procedural and clinical success, complications, and follow-up. Procedural details can be related to anatomic situations, comorbid processes, devices, and effective aneurysmal exclusion. Results: These data would allow assessment of the procedures, physician learning curves, procedural indications, techniques, methodologies, the relationship of indications to success and complications, devices and subsequent graft patency, and aneurysmal exclusion. Conclusions: The use of this standardized data collection system could enable physicians and industry to better understand endovascular AAA repair and ultimately improve patient care.

Pre- and Intraoperative Transcranial Doppler: Prediction and Surveillance of Tolerance to Carotid Clamping

We report 91 patients (mean age 70 years) operated upon, prospectively for a total of 100 carotid revascularizations (nine bilateral). Eighty-five of these patients had pre-, intra-, and postoperative transcranial Doppler investigations. Preoperatively, these 85 patients (92 procedures) were classified into two groups based on the results of their Doppler examinations: Group A (65 patients, 72 procedures), those who did not require an intraoperative indwelling shunt and Group B (20 patients, 20 procedures), those who did. The shunt was inserted only when the mean stump (back) pressure was less than 50 mmHg after cross-clamping. Group A all had satisfactory collaterality with a functional anterior and one or two posterior communicating arteries. Group B had no communicating arteries (anterior or posterior) identified by transcranial Doppler. In 17 of 20 patients in this group, the stump pressure was less than 50 mmHg and a shunt was placed. The overall prediction based on Doppler examination of whether or not patients would need a shunt during operation for the two groups A and B (i.e., 92 procedures) was correct in 95.6% (88/92) of cases. Moreover, six hemodynamically significant stenoses (four in the cavernous portion, two in the middle cerebral artery) were disclosed. Sensitivity and specificity of transcranial Doppler as correlated with arteriographic findings were 70 and 90%. Preoperative transcranial Doppler can measure the velocities of the principal cerebral arteries and the collateral capacity of the circle of Willis, and can forecast tolerance to carotid cross-clamping. Intraoperatively, the velocity of flow in the middle carotid artery was correlated with stump pressure, which allowed for surveillance of the shunt.