scholarly journals Early Outcomes in the ROADSTER 2 Study of Transcarotid Artery Revascularization in Patients With Significant Carotid Artery Disease

Stroke ◽  
2020 ◽  
Vol 51 (9) ◽  
pp. 2620-2629 ◽  
Author(s):  
Vikram S. Kashyap ◽  
Peter A. Schneider ◽  
Mazin Foteh ◽  
Raghu Motaganahalli ◽  
Rasesh Shah ◽  
...  
Keyword(s):  
Myocardial Infarction ◽  
High Risk ◽  
Carotid Artery ◽  
Death Rate ◽  
Technical Success ◽  
Protocol Population ◽  
Procedural Success ◽  
Intent To Treat ◽  
Treat Population ◽  
Stroke Death

Background and Purpose: Transcarotid artery revascularization (TCAR) is comprised of carotid artery stent placement with cerebral protection via proximal carotid artery clamping and reversal of cerebral arterial flow. The aim of the present study was to evaluate the safety and efficacy of TCAR performed by a broad group of physicians with variable TCAR experience. Methods: The ROADSTER 2 study is a prospective, open label, single arm, multicenter, postapproval registry for patients undergoing TCAR. Patients considered at high risk for complications from carotid endarterectomy with symptomatic stenosis ≥50% or asymptomatic stenosis ≥80% were included. The primary end point was procedural success, which encompassed technical success plus the absence of stroke, myocardial infarction, or death within the 30-day postoperative period. Secondary end points included technical success and individual/composite rates of stroke, death, and myocardial infarction (MI). All patients underwent independent neurological assessments before the procedure, within 24 hours, and at 30 days after TCAR. An independent clinical events committee adjudicated all major adverse events. Results: Between 2015 and 2019, 692 patients (Intent to Treat Population) were enrolled at 43 sites. Sixty cases had major protocol violations, leaving 632 patients adhering to the Food and Drug Administration-approved protocol (per-protocol population). The majority (81.2%) of operators were TCAR naïve before study initiation. Patients underwent TCAR for neurological symptoms in 26% of cases, and all patients had high-risk factors for carotid endarterectomy (anatomic-related 44%; physiological 32%; both 24%). Technical success occurred in 99.7% of all cases. The primary end point of procedural success rate in the Intent to Treat population was 96.5% (per-protocol 97.9%). The early postoperative outcomes in the Intent to Treat population included stroke in 13 patients (1.9%), death in 3 patients (0.4%), and MI in 6 patients (0.9%). The composite 30-day stroke/death rate was 2.3%, and stroke/death/MI rate was 3.2%. In the per-protocol population, there were strokes in 4 patients (0.6%), death in one patient (0.2%), and MI in 6 patients (0.9%) leading to a composite 30-day stroke/death rate of 0.8% and stroke/death/MI rate of 1.7%. Conclusions: TCAR results in excellent early outcomes with high technical success combined with low rates of postprocedure stroke and death. These results were achieved by a majority of operators new to this technology at the start of the trial. Adherence to the study protocol and peri-procedural antiplatelet therapy optimizes outcomes. Longer-term follow-up data are needed to confirm these early outcomes. Registration: URL: https://www.clinicaltrials.gov . Unique identifier: NCT02536378.

scholarly journals CHARACTERISTICS AND OUTCOMES OF ROTATIONAL ATHERECTOMY IN A TERTIARY CARE CARDIOLOGY FACILITY IN PAKISTAN

2021 ◽  
Vol 54 (3) ◽  
pp. 214-218
Author(s):  
Bilal Kabeer Khan ◽  
Osman Faheem ◽  
Muhammad Nasir Rahman
Keyword(s):  
Myocardial Infarction ◽  
High Risk ◽  
Tertiary Care ◽  
Rotational Atherectomy ◽  
Ethical Review ◽  
Major Adverse Cardiovascular Events ◽  
Syntax Score ◽  
Repeat Revascularization ◽  
Procedural Success ◽  
Almost All

Objectives: To retrospectively review the short term outcomes of rotational atherectomy in a high CathPCI Risk and high Syntax Population. Methodology: A total of 51 patients who underwent RA between 1st June 2017 and 31st April 2019 were retrospectively reviewed after approval from ethical review committee. Clinical follow up was obtained for procedural success and major adverse cardiovascular events (MACE) at 3 months. Results: Patients who underwent RA were high risk with a mean Syntax score 32.7±5.9 and mean NCDR CathPCI risk score of 51.1±13. The mean age of the patients were 70 years, majority were males (81%), type 2 diabetics (78%) with chronic kidney disease (52.7%), Non-ST elevated myocardial infarction (NSTEMI) (35%) and Syntax Score>32 (64.8%). Out of 37 individuals, procedural success was reported in all subjects except one in the high risk syntax group. At three months, MACE was reported in 4 patients. Out of these four, one was intra-procedural death, three had repeat myocardial infarction. Out of these three, two declined repeat revascularization and were managed medically. One patient died during admission despite repeat revascularization. Almost all MACE reported, occurred in patients with Syntax>32. Conclusion: Despite high risk Syntax and CathPCI scores, RA led to high immediate procedural success for PCI in calcified lesions at our hospital with infrequent MACE.

Carotid artery angioplasty and use of stents in high-risk patients with contralateral occlusions

1999 ◽  
Vol 90 (6) ◽  
pp. 1031-1036 ◽  
Author(s):  
Robert A. Mericle ◽  
Stanley H. Kim ◽  
Giuseppe Lanzino ◽  
Demetrius K. Lopes ◽  
Ajay K. Wakhloo ◽  
...  
Keyword(s):  
High Risk ◽  
Carotid Artery ◽  
Carotid Endarterectomy ◽  
Stent Placement ◽  
Death Rate ◽  
Minor Stroke ◽  
Content Type ◽  
Symptomatic Carotid ◽  
Fine Print

Object. The risks associated with carotid endarterectomy (CEA) are increased in the presence of contralateral carotid artery (CA) occlusion. The 30-day stroke and death rate for patients in the North American Symptomatic Carotid Endarterectomy Trial (NASCET) who had contralateral CA occlusion was 14.3%. The authors analyze their experience with angioplasty and/or stent placement in patients with contralateral CA occlusion to determine the safety and efficacy of endoluminal revascularization in this subgroup.Methods. Twenty-six procedures were evaluated in 23 patients with high-grade CA stenosis and contralateral CA occlusion. The first 15 procedures were evaluated retrospectively, and the next 11 prospectively. All patients had severe medical comorbidities and were considered too high risk for CEA, even without considering the contralateral occlusion. Clinical follow-up review was performed an average of 18 months later (median 15 months).Conclusions. The average ipsilateral CA stenosis according to NASCET criteria was 78% preprocedure and 5% postprocedure. There were no changes in neurological or functional outcome immediately postoperatively in any patient. The 30-day postoperative stroke and death rates were zero. However, there was one symptomatic femoral hematoma that resolved without surgery. At follow up, there were three patients who had suffered stroke or death. One patient died secondary to respiratory arrest at 2 months; one died secondary to prostate carcinoma at 12 months; and one patient experienced a minor stroke contralateral to the treated artery at 41 months. Despite the substantial preoperative risk factors in patients in this series, the 30-day stroke and death rate for angioplasty and/or stent placement appears to be lower than that of CEA in patients with contralateral occlusions.

scholarly journals Endovascular and surgical management of carotid artery restenosis

2007 ◽  
Vol 54 (3) ◽  
pp. 43-46 ◽  
Author(s):  
D.Z. Sagic ◽  
Z.D. Antonic ◽  
B.B. Petrovic ◽  
S.N. Duvnjak ◽  
M.S. Peric ◽  
...  
Keyword(s):  
Myocardial Infarction ◽  
Carotid Artery ◽  
Endovascular Treatment ◽  
Transient Ischemic Attack ◽  
Myocardial Infraction ◽  
Ischemic Attack ◽  
Stroke Death ◽  
Surgical Group ◽  
Major Stroke

Background. The incidence of recurrent carotid stenosis after primary endarterectomy ranges from 10-34%. We presented our four year experience and comparing reoperation versus endovascular treatment. Methods. In period from 2001 to 2005, 50 patients, 37 men and 13 women, were treated surgically and endovascular due to restenosis. Results. There were no minor or major stroke, death and myocardial infarction periprocedural and in first 30 days in either group. In endovascular group one patients 3,17% had transient ischemic attack and two patients 11,76% in surgical group. One patient died from myocardial infraction in follow up in surgical group. There were no restenosis >50% in endovascular group, two patients have restenosis >50% in surgical group. Conclusions. Endovascular treatment of carotid artery restenosis represents a safe and efficient way of treatment, connected with minor number of serious complications than redo operation.

scholarly journals Double-Blind, Randomized Study of the Efficacy and Safety of Oral Pharmacokinetically Enhanced Amoxicillin-Clavulanate (2,000/125 Milligrams) versus Those of Amoxicillin-Clavulanate (875/125 Milligrams), Both Given Twice Daily for 7 Days, in Treatment of Bacterial Community-Acquired Pneumonia in Adults

2004 ◽  
Vol 48 (9) ◽  
pp. 3323-3331 ◽  
Author(s):  
T. M. File ◽  
H. Lode ◽  
H. Kurz ◽  
R. Kozak ◽  
H. Xie ◽  
...  
Keyword(s):  
Confidence Interval ◽  
Clinical Success ◽  
Community Acquired Pneumonia ◽  
Double Blind ◽  
Treatment Difference ◽  
Oral Amoxicillin ◽  
Protocol Population ◽  
Amoxicillin Clavulanate ◽  
Intent To Treat ◽  
Treat Population

ABSTRACT This randomized, double-blind, noninferiority trial was designed to demonstrate that pharmacokinetically enhanced amoxicillin-clavulanate (2,000/125 mg) was at least as effective clinically as amoxicillin-clavulanate 875/125 mg, both given twice daily for 7 days, in the treatment of community-acquired pneumonia in adults. In total, 633 clinically and radiologically confirmed community-acquired pneumonia patients (intent-to-treat population) were randomized to receive either oral amoxicillin-clavulanate 2,000/125 mg (n = 322) or oral amoxicillin-clavulanate 875/125 mg (n = 311). At screening, 160 of 633 (25.3%) patients had at least one typical pathogen isolated from expectorated or invasive sputum samples or blood culture (bacteriology intent-to-treat population). Streptococcus pneumoniae (58 of 160, 36.3%), methicillin-susceptible Staphylococcus aureus (34 of 160, 21.3%), and Haemophilus influenzae (33 of 160, 20.6%) were the most common typical causative pathogens isolated in both groups in the bacteriology intent-to-treat population. Clinical success in the clinical per protocol population at test of cure (days 16 to 37), the primary efficacy endpoint, was 90.3% (223 of 247) for amoxicillin-clavulanate 2,000/125 mg and 87.6% (198 of 226) for amoxicillin-clavulanate 875/125 mg (treatment difference, 2.7; 95% confidence interval, −3.0, 8.3). Bacteriological success at test of cure in the bacteriology per protocol population was 86.6% (58 of 67) for amoxicillin-clavulanate 2,000/125 mg and 78.4% (40 of 51) for amoxicillin-clavulanate 875/125 mg (treatment difference, 8.1%; 95% confidence interval, −5.8, 22.1). Both therapies were well tolerated. Amoxicillin-clavulanate 2,000/125 mg twice daily was shown to be as clinically effective as amoxicillin-clavulanate 875/125 mg twice daily for 7 days in the treatment of adult patients with community-acquired pneumonia, without a noted increase in the reported rate of adverse events.

scholarly journals Demographic And Technical Risk Factors Of 30-Day Stroke, Myocardial Infarction, And/Or Death In Standard And High Risk Patients Who Underwent Carotid Angioplasty And Stenting

2017 ◽  
pp. 13
Author(s):  
Samaneh Yousefi ◽  
Ehsan Bahramali ◽  
Safoora Kokabi ◽  
Seyed Taghi Heydari ◽  
Abdolhamid Shariat ◽  
...  
Keyword(s):  
Risk Factors ◽  
Myocardial Infarction ◽  
High Risk ◽  
Carotid Artery ◽  
Carotid Angioplasty ◽  
Short Term ◽  
High Risk Patients ◽  
Risk Patients ◽  
Angioplasty And Stenting ◽  
Carotid Angioplasty And Stenting

Background: Carotid angioplasty and stenting (CAS) is an accepted treatment to prevent stroke in patients with carotid artery stenosis. The purpose of this study is to identify risk factors for major complications after carotid angioplasty and stenting.Methods and Material: This is a prospective study conducted at Shiraz University of Medical Sciences in southern Iran from March 2011 to June 2014. Consecutive patients undergoing carotid angioplasty and stenting were enrolled. Both standard risk and high risk patients for endarterectomy were enrolled. Demographic data, atherosclerotic risk factors, site of stenosis, degree of stenosis, and data regarding technical factors were recorded. 30-day stroke, myocardial infarction, and/or death were considered as the composite primary outcome of the study.Results:  two hundred and fifty one patients were recruited (mean age: 71.1+ 9.6 years, male: 65.3%).  One hundred and seventy eight (70.9%) patients were symptomatic; 73 (29.1%), 129 (51.4%), 165 (65.7%) and 62 (24.7%) patients were diabetic, hyperlipidemic, hypertensive and smoker respectively. CAS performed for left ICA in 113 (45.4%) patients. 14 (5.6%) patients had Sequential bilateral stenting. Mean stenosis of operated ICA was 80.2 +13.8 %. Embolic protection device was used in 203 (96.2%) patients. Predilation and post-dilation were performed in 39 (18.5%) and 182 (86.3%) patients respectively. Composite outcome was observed in 3.6% (3.2% stroke, 0% myocardial infarction and 1.2% death). Left sided lesions and presence of DM was significantly associated with poor short term outcome. (P value: 0.025 and 0.020, respectively)Conclusion: There was a higher risk of short term major complications in diabetic patients and left carotid artery intervention. 

Correlation of Periprocedural Systolic Blood Pressure Changes with Neurological Events in High-Risk Carotid Stent Patients

2002 ◽  
Vol 9 (6) ◽  
pp. 810-816 ◽  
Author(s):  
Marcus Howell ◽  
Zvonimir Krajcer ◽  
Kathy Dougherty ◽  
Neil Strickman ◽  
Mark Skolkin ◽  
...  
Keyword(s):  
Blood Pressure ◽  
High Risk ◽  
Carotid Artery ◽  
Systolic Blood Pressure ◽  
Carotid Stenting ◽  
Hemodynamic Instability ◽  
Number Of Patients ◽  
Risk Patients ◽  
Procedural Success ◽  
Bilateral Lesions

Purpose: To examine retrospectively the magnitude of change in systolic blood pressure (SBP) during carotid artery stenting and its relationship to neurological events. Methods: In a 5-year period ending October 2000, 60 patients (36 men; mean age 67 ± 9 years) were enrolled in a study to evaluate stenting in symptomatic or asymptomatic high-risk patients with ≥70% carotid artery stenosis. The majority (48, 80%) of the patients were symptomatic. Five patients with bilateral lesions were treated in staged procedures. Sixteen (25%) of the 65 lesions were postsurgical stenoses and 12 (18%) were secondary to neck radiation therapy. Results: There were 2 (3%) minor and 2 (3%) major strokes (94% procedural success), of which 1 was fatal. Six (9%) transient neurological events were recorded during balloon inflation. The mean SBP change during or after stenting in 55 cases without neurological events was 34 ± 14 mmHg, while the patients with transient or permanent neurological events had significantly greater changes in SBP (107 ± 31 mmHg [p<0.003] and 134 ± 14 mmHg [p<0.001], respectively). Patients exhibiting neurological sequelae had significantly higher SBP before the procedure than those without complications (203 ± 30 versus 165 ± 23 mmHg, p<0.001). There were no neurological events in patients with a <50-mmHg change in SBP. Conclusions: Patients with severely elevated baseline SBP (>180 mmHg) may be at higher risk for hemodynamic instability and neurological events during carotid stenting. The greater the change in SBP, the more severe the neurological event seems to be, but further studies in a greater number of patients are needed to evaluate the potential causes of SBP fluctuations in an effort to avoid neurological events.

Periprocedural risk and long-term outcome of intracranial angioplasty based on a single-centre experience

VASA ◽  
2013 ◽  
Vol 42 (4) ◽  
pp. 264-274
Author(s):  
Dagmar Krajíčková ◽  
Antonín Krajina ◽  
Miroslav Lojík ◽  
Martina Mulačová ◽  
Martin Vališ
Keyword(s):  
Death Rate ◽  
Long Term Outcomes ◽  
Single Centre ◽  
Intracranial Atherosclerotic Stenosis ◽  
Atherosclerotic Stenosis ◽  
Angioplasty And Stenting ◽  
Aggressive Medical Management ◽  
Stroke Death

Background: Intracranial atherosclerotic stenosis is a major cause of stroke and yet there are currently no proven effective treatments for it. The SAMMPRIS trial, comparing aggressive medical management alone with aggressive medical management combined with intracranial angioplasty and stenting, was prematurely halted when an unexpectedly high rate of periprocedural events was found in the endovascular arm. The goal of our study is to report the immediate and long-term outcomes of patients with ≥ 70 % symptomatic intracranial atherosclerotic stenosis treated with balloon angioplasty and stent placement in a single centre. Patients and methods: This is a retrospective review of 37 consecutive patients with 42 procedures of ballon angioplasty and stenting for intracranial atherosclerotic stenosis (≥ 70 % stenosis) treated between 1999 and 2012. Technical success (residual stenosis ≤ 50 %), periprocedural success (no vascular complications within 72 hours), and long-term outcomes are reported. Results: Technical and periprocedural success was achieved in 90.5 % of patients. The within 72 hours periprocedural stroke/death rate was 7.1 % (4.8 % intracranial haemorrhage), and the 30-day stroke/death rate was 9.5 %. Thirty patients (81 %) had clinical follow-up at ≥ 6 months. During follow-up, 5 patients developed 6 ischemic events; 5 of them (17 %) were ipsilateral. The restenosis rate was 27 %, and the retreatment rate was 12 %. Conclusions: Our outcomes of the balloon angioplasty/stent placement for intracranial atherosclerotic stenosis are better than those in the SAMMPRIS study and compare favourably with those in large registries and observational studies.

Outcome of carotid endarterectomy under local anaesthesia with respect to the patients’ risk profile

VASA ◽  
2009 ◽  
Vol 38 (3) ◽  
pp. 225-233 ◽  
Author(s):  
Aleksic ◽  
Luebke ◽  
Brunkwall
Keyword(s):  
Myocardial Infarction ◽  
High Risk ◽  
Carotid Endarterectomy ◽  
Complication Rate ◽  
Local Anaesthesia ◽  
High Risk Group ◽  
High Risk Patients ◽  
Hostile Neck ◽  
Risk Patients ◽  
Angioplasty And Stenting

Background: In the present study the perioperative complication rate is compared between high- and low-risk patients when carotid endarterectomy (CEA) is routinely performed under local anaesthesia (LA). Patients and methods: From January 2000 through June 2008 1220 consecutive patients underwent CEA under LA. High-risk patients fulfilled at least one of the following characteristics: ASA 4 classification, “hostile neck”, recurrent ICA stenosis, contralateral ICA occlusion, age ≥ 80 years. The combined complication rate comprised any new neurological deficit (TIA or stroke), myocardial infarction or death within 30 days after CEA, which was compared between patient groups. Results: Overall 309 patients (25%) were attributed to the high-risk group, which differed significantly regarding sex distribution (more males: 70% vs. 63%, p = 0,011), neurological presentation (more asymptomatic: 72% vs. 62%, p = 0,001) and shunt necessity (33% vs. 14%, p < 0,001). In 32 patients 17 TIAs and 15 strokes were observed. In 3 patients a myocardial infarction occurred. Death occurred in one patient following a stroke and in another patient following myocardial infarction, leading to a combined complication rate of 2,9% (35/1220). In the multivariate analysis only previous neurological symptomatology (OR 2,85, 95% CI 1,38-5,91) and intraoperative shunting (OR 5,57, 95% CI 2,69-11,55) were identified as independent risk factors for an increased combined complication rate. Conclusions: With the routine use of LA, CEA was not associated with worse outcome in high-risk patients. Considering the data reported in the literature, it does not appear justified to refer high-risk patients principally to carotid angioplasty and stenting (CAS) when LA can be chosen to perform CEA.

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