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1.
Oxf Med Case Reports ; 2023(10): omad086, 2023 Oct.
Article En | MEDLINE | ID: mdl-37881260

De novo aortic regurgitation (AR) presents a great challenge following left ventricular assist device (LVAD) implantation and requires valve replacement in some cases. Patients with LVAD are frequently those who underwent multiple previous sternotomies or suffer from multiple comorbidities. Thus, they are at high surgical risk for further sternotomy. Transcatheter aortic valve implantation (TAVI) previously approved for treatment of severe aortic stenosis is also used for this category of patients. Here, we report the case of a young female patient supported with heart mate II LVAD who presented with severe de novo AR. The patient was successfully treated with TAVI using Myval trancatheter heart valve (THV) in our center. To our knowledge, our patient is the first to be treated with such type of valve using TAVI procedure in LVAD supported patients.

2.
Stroke ; 47(9): 2286-91, 2016 09.
Article En | MEDLINE | ID: mdl-27491736

BACKGROUND AND PURPOSE: The capillary index score (CIS) is based on the hypothesis that areas lacking capillary blush on pretreatment cerebral digital subtraction angiograms correspond to nonviable cerebral tissue. METHODS: Pretreatment digital subtraction angiograms and post-treatment noncontrast enhanced computed tomographic scans from the MR CLEAN (Multicenter Randomized Clinical Trial of Endovascular Treatment for Acute Ischemic Stroke in the Netherlands) trial were evaluated for areas lacking capillary blush and with tissue hypodensity, respectively. Because the superior and middle zones of the CIS correspond to the 7 cerebral cortex regions of the Alberta Stroke Program Early CT (ASPECT) score, capillary blush was scored in these 2 zones (0-2), called sub-CIS, and compared with the ASPECT score in these 7 regions (0-7), called hypodensity score. The presence and extent of hypodensity were compared between sub-CIS zones with contingency tables and nonparametric comparisons between groups, respectively. RESULTS: On the basis of a sample size of 50 subjects, 100% with sub-CIS <2 had the presence of hypodensity (hypodensity score ≥1) versus 57% for sub-CIS=2 (P=0.004). The extent of hypodensity (numeric hypodensity score) was significantly lower for sub-CIS=2 than 0 or 1 (P=0.02). For 42 subjects with revascularization data, the presence and extent of hypodensity were significantly lower for sub-CIS=2 plus good revascularization than for other combinations of sub-CIS and revascularization (P=0.02 and 0.01, respectively). CONCLUSIONS: The absence of capillary blush on pretreatment digital subtraction angiogram seems to correspond to nonviable cerebral tissue. Successful revascularization reduces the chance of tissue hypodensity (infarction), when capillary blush is present. CLINICAL TRIAL REGISTRATION: URL: http://www.trialregister.nl. Unique identifier: NTR number 1804. URL: http://www.isrctn.com. Unique identifier: ISRCTN10888758.


Angiography, Digital Subtraction/methods , Brain Ischemia/diagnostic imaging , Brain/diagnostic imaging , Capillaries/diagnostic imaging , Computed Tomography Angiography/methods , Stroke/diagnostic imaging , Brain Ischemia/therapy , Endovascular Procedures/methods , Humans , Stroke/therapy , Treatment Outcome
4.
Front Neurol ; 6: 117, 2015.
Article En | MEDLINE | ID: mdl-26082751

Due to recent results from clinical intra-arterial treatment for acute ischemic stroke (IAT-AIS) trials such as the interventional management of stroke III, IAT-AIS and the merit of revascularization have been contested. Even though intra-arterial treatment (IAT) has been shown to improve revascularization rates, a corresponding increase in good outcomes has only recently been noted. Even though a significant percentage of patients achieve good revascularization in a timely manner, results do not translate into good clinical outcomes (GCOs). Based on a review of the literature, the authors suspect limited GCOs following timely and successful revascularization are due to poor patient selection that led to futile and possibly even harmful revascularization. The capillary index score (CIS) is a simple angiography-based scale that can potentially be used to improve patient selection to prevent revascularization being performed on patients who are unlikely to benefit from treatment. The CIS characterizes presence of capillary blush related to collateral flow as a marker of residual viable tissue, with absence of blush indicating the tissue is no longer viable due to ischemia. By only selecting patients with a favorable CIS for IAT, the rate of GCOs should consistently approach 80-90%. Current methods of patient selection are primarily dependent on time from ischemia. Time from cerebral ischemia to irreversible tissue damage seems to vary from patient to patient; so focusing on viable tissue based on the CIS rather than relying on an artificial time window seems to be a more appropriate approach to patient selection.

5.
Front Neurol ; 6: 83, 2015.
Article En | MEDLINE | ID: mdl-25954243

The current strategy for intra-arterial treatment (IAT) of acute ischemic stroke focuses on minimizing time from ictus to revascularization and maximizing revascularization. Employing this strategy has yet to lead to improved rates of successful outcomes. However, the collateral blood supply likely plays a significant role in maintaining viable brain tissue during ischemia. Based on our prior work, we believe that only approximately 50% of patients are genetically predisposed to have sufficient collaterals for a good outcome following treatment, a concept we call the 50% barrier. The Capillary Index Score (CIS) has been developed as a tool to identify patients with a sufficient collateral blood supply to maintain tissue viability prior to treatment. Patients with a favorable CIS (f CIS) may be able to achieve a good outcome with IAT beyond an arbitrary time window. The CIS is incorporated into a proposed patient treatment algorithm. For patients suffering from a large stroke without aphasia, a non-enhanced head CT should be followed by CT angiography (CTA). For patients without signs of stroke mimics or visible signs of structural changes due to large irreversible ischemia, CTA can help confirm the vascular occlusion and location. The CIS can be obtained from a diagnostic cerebral angiogram, with IAT offered to patients categorized as f CIS.

6.
Stroke ; 46(6): 1590-4, 2015 Jun.
Article En | MEDLINE | ID: mdl-25953374

BACKGROUND AND PURPOSE: Until recently, acute ischemic stroke (AIS) trials have failed to show a benefit of endovascular therapy compared with standard therapy, leading some authors to recommend decreasing the time from ictus to revascularization to improve outcomes. We hypothesize that improving patient selection using the capillary index score (CIS) may also be a useful strategy. METHODS: CIS was calculated, blinded to outcome, from pretreatment diagnostic cerebral angiograms for 78 subjects in the Interventional Management of Stroke III database with internal carotid artery and middle cerebral artery trunk occlusion. The CIS was dichotomized into favorable (fCIS=2 or 3) and poor (pCIS=0 or 1). Outcomes were categorized based on the modified Rankin Scale score at 90 days (0-2 considered a good outcome). Modified thrombolysis in cerebral infarction score 2b or 3 was considered good revascularization. Multivariable logistic regression was performed to relate CIS, time from ictus to revascularization, modified thrombolysis in cerebral infarction score, and National Institue of Health Stroke Scale score to good outcomes. RESULTS: Only CIS and modified thrombolysis in cerebral infarction scores were correlated with good outcomes (P<0.01). Patients with fCIS and good revascularization achieved 71% modified Rankin Scale≤2, compared with 13% for patients with pCIS and good revascularization. CONCLUSIONS: In this subset of patients from the Interventional Management of Stroke III Trial, CIS and modified thrombolysis in cerebral infarction were strong predictors of outcome after endovascular reperfusion. Using the CIS to improve patient selection could be a powerful strategy to improve rate of good outcomes in endovascular therapy. A randomized trial is needed. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT00359424.


Carotid Artery Diseases/drug therapy , Cerebral Angiography , Cerebral Revascularization , Infarction, Middle Cerebral Artery , Thrombolytic Therapy , Aged , Aged, 80 and over , Carotid Artery Diseases/diagnostic imaging , Female , Humans , Infarction, Middle Cerebral Artery/diagnostic imaging , Infarction, Middle Cerebral Artery/drug therapy , Male , Middle Aged
7.
Front Neurol ; 5: 101, 2014.
Article En | MEDLINE | ID: mdl-25002858

We review the methods and results of Stenting and Aggressive Medical Management for Preventing Recurrent Stroke (SAMMPRIS) and provide a critical review of its strengths and limitations. In SAMMPRIS, the aggressive medical treatment arm (AMT arm) did substantially better than the Wingspan Stenting plus aggressive medical management arm (WS+ arm). Complications in the first 30 days post intervention led to the disparity between treatment arms. A major contribution of SAMMPRIS was the added value that AMT and lifestyle change may provide, when compared to a precursor trial, Warfarin-Aspirin Symptomatic Intracranial Disease (WASID), designed to prevent stroke in persons with high-grade symptomatic intracranial occlusive disease, however, the results of neither of these two trials have ever been reproduced. On the other hand, we argue that technical limitations of the Wingspan stent system (WS System) and lack of an angioplasty only intervention arm may have led to a premature launch of the trial and early termination of the study. Future randomized trials with different devices and modified patient selection criteria are warranted.

8.
Stroke ; 45(7): 1999-2003, 2014 Jul.
Article En | MEDLINE | ID: mdl-24851874

BACKGROUND AND PURPOSE: The Capillary Index Score (CIS) is a simple angiography-based scale for assessing viable tissue in the ischemic territory. We retrospectively applied it to Interventional Management of Stroke (IMS) trials I and II to evaluate the predictive value for good outcomes. METHODS: CIS was calculated from pretreatment diagnostic cerebral angiograms blinded to outcome. IMS I and II diagnostic cerebral angiogram images of sufficient quality were reviewed and CIS calculated for treated subjects with internal carotid artery or M1 occlusion. CIS scoring (0-3) was dichotomized into favorable (f CIS; 2 or 3) and poor (p CIS; 0 or 1). Modified thrombolysis in cerebral infarction score 2b or 3 was considered good revascularization. CIS and modified thrombolysis in cerebral infarction scores were compared with good outcome, defined as modified Rankin Scale score≤2 at 90 days. RESULTS: Twenty-eight of 161 subjects met the inclusion criteria. Thirteen (46%) had f CIS. Good clinical outcome was significantly different between the 2 CIS groups (62% for f CIS versus 7% for p CIS; P=0.004). Good reperfusion correlated to good outcome (P=0.04). No significant differences in time to intravenous or intra-arterial treatment were identified between f CIS and p CIS groups (P>0.25). CONCLUSIONS: A f CIS was found in ≈50% of subjects and was a virtual prerequisite for good outcome in this study subgroup of IMS I and II. We call this the 50% barrier.


Brain Ischemia/pathology , Capillaries/diagnostic imaging , Cerebral Angiography/statistics & numerical data , Fibrinolytic Agents/pharmacology , Stroke/pathology , Thrombolytic Therapy/methods , Aged , Brain Ischemia/diagnostic imaging , Brain Ischemia/therapy , Carotid Artery Diseases/diagnostic imaging , Carotid Artery Diseases/pathology , Carotid Artery Diseases/therapy , Cerebral Infarction/diagnostic imaging , Cerebral Infarction/pathology , Cerebral Infarction/therapy , Clinical Trials as Topic , Disease Management , Female , Fibrinolytic Agents/administration & dosage , Humans , Male , Middle Aged , Predictive Value of Tests , Prognosis , Retrospective Studies , Severity of Illness Index , Single-Blind Method , Stroke/diagnostic imaging , Stroke/therapy
9.
Stroke ; 45(3): 759-64, 2014 Mar.
Article En | MEDLINE | ID: mdl-24473178

BACKGROUND AND PURPOSE: Endovascular strategies provide unique opportunity to correlate angiographic measures of collateral circulation at the time of endovascular therapy. We conducted systematic analyses of collaterals at conventional angiography on recanalization, reperfusion, and clinical outcomes in the endovascular treatment arm of the Interventional Management of Stroke (IMS) III trial. METHODS: Prospective evaluation of angiographic collaterals was conducted via central review of subjects treated with endovascular therapy in IMS III (n=331). Collateral grade before endovascular therapy was assessed with the American Society of Interventional and Therapeutic Neuroradiology/Society of Interventional Radiology scale, blinded to all other data. Statistical analyses investigated the association between collaterals with baseline clinical variables, angiographic measures of recanalization, reperfusion and clinical outcomes. RESULTS: Adequate views of collateral circulation to the ischemic territory were available in 276 of 331 (83%) subjects. Collateral grade was strongly related to both recanalization of the occluded arterial segment (P=0.0016) and downstream reperfusion (P<0.0001). Multivariable analyses confirmed that robust angiographic collateral grade was a significant predictor of good clinical outcome (modified Rankin Scale score≤2) at 90 days (P=0.0353), adjusted for age, history of diabetes mellitus, National Institutes of Health Stroke Scale strata, and Alberta Stroke Program Early CT Score. The relationship between collateral flow and clinical outcome may depend on the degree of reperfusion. CONCLUSIONS: More robust collateral grade was associated with better recanalization, reperfusion, and subsequent better clinical outcomes. These data, from the largest endovascular trial to date, suggest that collaterals are an important consideration in future trial design. CLINICAL TRIAL REGISTRATION URL: http://www.clinicaltrials.gov. Unique identifier: NCT00359424.


Cerebral Angiography/methods , Collateral Circulation/physiology , Stroke/diagnosis , Stroke/therapy , Adult , Aged , Aged, 80 and over , Blood Pressure/physiology , Comorbidity , Diabetes Complications/epidemiology , Diabetes Complications/therapy , Endovascular Procedures , Female , Fibrinolytic Agents/therapeutic use , Humans , Male , Middle Aged , Multivariate Analysis , Reperfusion Injury/prevention & control , Thrombolytic Therapy/methods , Tissue Plasminogen Activator/therapeutic use , Treatment Outcome , Young Adult
10.
Front Neurol ; 4: 133, 2013.
Article En | MEDLINE | ID: mdl-24062720

BACKGROUND AND PURPOSE: The pathogenesis of spontaneous cervical artery dissections (sCAD) and its best medical treatment are debated. This may be due to a lack of clear classification of sCAD. We propose the new Borgess classification of sCAD, based on the presence or absence of intimal tear as depicted on imaging studies and effect on blood flow. MATERIALS AND METHODS: This is a single-center investigator-initiated registry on consecutive patients treated for sCAD. In the Borgess classification, type I dissections have intact intima and type II dissections have an intimal tear. RESULTS: Forty-four patients and 52 dissected arteries were found. Forty-nine of 52 dissections (93%) were treated with dual anti-platelet therapy. Twenty-one of 52 dissections were type I; 31 were type II. Type I dissections were more likely to present with ischemic symptoms [stroke, transient ischemic attack (TIA)] (p = 0.001). More type I dissections occurred in the vertebral artery, while more type II dissections occurred in the internal carotid artery (p < 0.001). Follow-up averaged 18.1 months (range: 3-108 months) with no recurrent ischemic events (stroke, TIA), deaths, or hemorrhage. Forty-six vessels had 6 month follow-up on medical treatment; 19/46 (41%) healed. Type I dissections were more likely to heal than type II (p < 0.001). CONCLUSION: The two dissection types in the Borgess classification appear to relate to clinical presentation and rate of healing, making the classification useful in clinical management. Dual anti-platelet therapy for sCAD seems to have a very low risk of subsequent stroke; however, a large prospective study is needed to investigate the best treatment.

11.
J Neurointerv Surg ; 5(2): 139-43, 2013 Mar.
Article En | MEDLINE | ID: mdl-22266703

BACKGROUND: Despite increased recanalization rates in the treatment of acute ischemic stroke, the percentage of patients with a good clinical outcome of all those treated has not risen above 50%. This 50% barrier may be broken by improving the criteria for treatment selection. This study investigated the addition of the capillary index score (CIS), a new index for assessing remaining viable tissue in the ischemic area, to the existing criteria. METHODS: The Borgess Medical Center Ischemic Stroke Registry is a non-randomized single-center single-operator registry of consecutive subjects admitted for intra-arterial treatment of acute ischemic stroke. The CIS was calculated from a pre-intervention catheter cerebral angiogram in subjects with internal carotid artery (ICA) or middle cerebral artery (MCA) (M1) occlusion. Thrombolysis In Myocardial Infarction (TIMI) 2 or 3 was considered successful recanalization. A modified Rankin Scale (mRS) of 0-2 at 3 months was considered a good outcome. RESULTS: ICA or MCA (M1) occlusion was found in 46 of 58 consecutive patients treated by the same operator. Recanalization was successful in 72% of patients and 27% had a good outcome. CIS was available for 26 patients; 42% were favorable (2 or 3) and 58% were poor (0 or 1). A good outcome was found only in the favorable CIS group (p=0.0148). Successful recanalization (p=0.0029) and time from ictus to revascularization (p=0.0039) predicted a good outcome. Of patients with favorable CIS and TIMI 3, 83% had a good outcome. CONCLUSIONS: Favorable CIS and recanalization were strong predictors of a good outcome. By using this new index as an adjunct to other criteria, the CIS may improve patient selection and help break the 50% barrier.


Academic Medical Centers , Algorithms , Brain Ischemia/diagnostic imaging , Capillaries/diagnostic imaging , Registries , Severity of Illness Index , Stroke/diagnostic imaging , Academic Medical Centers/standards , Aged , Brain Ischemia/epidemiology , Female , Humans , Male , Middle Aged , Radiography , Registries/standards , Stroke/epidemiology , Treatment Outcome
12.
Stroke ; 42(9): 2544-9, 2011 Sep.
Article En | MEDLINE | ID: mdl-21778441

BACKGROUND AND PURPOSE: Although atherosclerotic plaque in the carotid and coronary arteries is accepted as a cause of ischemia, vertebral artery ostium (VAO) atherosclerotic plaque is not widely recognized as a source of ischemic stroke. We seek to demonstrate its implication in some posterior circulation ischemia. METHODS: This is a nonrandomized, prospective, single-center registry on consecutive patients presenting with posterior circulation ischemia who underwent VAO stenting for significant atherosclerotic stenosis. Diagnostic evaluation and imaging studies determined the likelihood of this lesion as the symptom source (highly likely, probable, or highly unlikely). Patients were divided into 4 groups in decreasing order of severity of clinical presentation (ischemic stroke, TIA then stroke, TIA, asymptomatic), which were compared with the morphological and hemodynamic characteristics of the VAO plaque. Clinical follow-up 1 year after stenting assessed symptom recurrence. RESULTS: One hundred fourteen patients underwent stenting of 127 lesions; 35% of the lesions were highly likely the source of symptoms, 53% were probable, and 12% were highly unlikely. Clinical presentation correlated directly with plaque irregularity and presence of clot at the VAO, as did bilateral lesions and presence of tandem lesions. Symptom recurrence at 1 year was 2%. CONCLUSIONS: Thirty-five percent of the lesions were highly likely the source of the symptoms. A direct relationship between some morphological/hemodynamic characteristics and the severity of clinical presentation was also found. Finally, patients had a very low rate of symptom recurrence after treatment. These 3 observations point strongly to VAO plaque as a potential source of some posterior circulation stroke.


Hemodynamics , Intracranial Arteriosclerosis/physiopathology , Registries , Stroke , Vertebral Artery/physiopathology , Vertebrobasilar Insufficiency , Aged , Female , Follow-Up Studies , Humans , Intracranial Arteriosclerosis/complications , Male , Stroke/etiology , Stroke/physiopathology , Vertebrobasilar Insufficiency/complications , Vertebrobasilar Insufficiency/physiopathology
13.
Stroke ; 37(10): 2562-6, 2006 Oct.
Article En | MEDLINE | ID: mdl-16960090

BACKGROUND AND PURPOSE: The use of bare metal stents to treat symptomatic intracranial stenosis may be associated with significant restenosis rates. The advent of drug-eluting stents (DESs) in the coronary circulation has resulted in a reduction of restenosis rates. We report our technical success rate and short-term restenosis rates after stenting with DESs in the intracranial and extracranial circulation. METHODS: This study was a retrospective review of the period between April 1, 2004, and April 15, 2006, of 59 patients with 62 symptomatic intracranial or extracranial atherosclerotic lesions at 2 medical centers (University of Pittsburgh and Borgess Medical Center). RESULTS: The mean age of our cohort was 61+/-12 years. The location of the 62 lesions was as follows: extracranial vertebral artery 31 (50%), intracranial vertebral artery or basilar artery 18 (29%), extracranial internal carotid artery (ICA) near the petrous bone 5 (8%), and intracranial ICA 8 (13%). There were 2 (3%) periprocedural complications: 1 non-flow-limiting dissection and 1 disabling stroke. Fifty vessels were available for follow-up angiography or computed tomography angiography at a median time of 4.0+/-2 months. A total of 2 of 36 extracranial stents (7%) and 1 of 26 intracranial stents (5%) were found to have restenosis > or = 50% at follow-up. CONCLUSIONS: This report demonstrates that DES delivery in the intracranial and extracranial circulation is technically feasible. A small percentage of patients developed short-term in-stent restenosis. Longer-term follow-up is required in the setting of a prospective study to determine the late restenosis rates for DESs in comparison with bare metal stents.


Carotid Artery, External , Carotid Artery, Internal , Carotid Stenosis/therapy , Paclitaxel/therapeutic use , Sirolimus/therapeutic use , Stents/statistics & numerical data , Vertebrobasilar Insufficiency/therapy , Aortic Dissection/etiology , Anticoagulants/therapeutic use , Calcinosis/therapy , Carotid Stenosis/prevention & control , Catheterization , Cohort Studies , Drug Evaluation , Drug Implants , Feasibility Studies , Female , Follow-Up Studies , Humans , Ischemic Attack, Transient/drug therapy , Ischemic Attack, Transient/prevention & control , Ischemic Attack, Transient/therapy , Male , Middle Aged , Organ Specificity , Paclitaxel/administration & dosage , Paclitaxel/adverse effects , Recurrence , Retrospective Studies , Sirolimus/administration & dosage , Sirolimus/adverse effects , Stents/adverse effects , Stroke/etiology , Vertebrobasilar Insufficiency/prevention & control
14.
Stroke ; 37(4): 1016-20, 2006 Apr.
Article En | MEDLINE | ID: mdl-16497979

BACKGROUND AND PURPOSE: Medical treatment of symptomatic intracranial stenosis carries a high risk of stroke. This study was done to evaluate the clinical and angiographic outcomes after intracranial angioplasty for this disease. METHODS: A total of 120 patients with 124 intracranial stenoses were treated by primary angioplasty. All patients had neurologic symptoms (stroke or transient ischemic attack) attributable to intracranial stenoses > or =50%. Angiograms were evaluated before and after angioplasty for the degree of stenosis. RESULTS: Pretreatment stenoses varied from 50% to 95% (mean 82.2+/-10.2). Post-treatment stenoses varied from 0% to 90% (mean 36.0+/-20.1). There were 3 strokes and 4 deaths (all neurological) within 30 days of the procedure, giving a combined periprocedural stroke and death rate of 5.8%. A total of 116 patients (96.7%) were available for a mean follow-up time of 42.3 months. There were 6 patients who had a stroke in the territory of treatment and 5 additional patients with stroke in other territories. Ten deaths occurred during the follow-up period, none of which were neurological. Including the periprocedural stroke and deaths, this yielded an annual stroke rate of 3.2% in the territory of treatment and a 4.4% annual rate for all strokes. CONCLUSIONS: Intracranial angioplasty can be performed with a high degree of technical success and a low risk of complications. Long-term clinical follow-up of intracranial angioplasty patients demonstrates a risk of future strokes that compares favorably to patients receiving medical therapy.


Angioplasty , Intracranial Arteriosclerosis/therapy , Adult , Aged , Aged, 80 and over , Angioplasty/adverse effects , Angioplasty/mortality , Cerebral Angiography , Constriction, Pathologic/diagnostic imaging , Constriction, Pathologic/therapy , Female , Follow-Up Studies , Humans , Intracranial Arteriosclerosis/diagnostic imaging , Male , Middle Aged , Stroke/etiology , Treatment Outcome
15.
AJNR Am J Neuroradiol ; 26(9): 2410-4, 2005 Oct.
Article En | MEDLINE | ID: mdl-16219856

We report on a patient with oligodendroglioma metastatic to bone, presenting with pancytopenia and fever 10 years after initial tumor resection. Our review of the literature showed a total of 30 reported extraneural metastases, with only 19 of these being similar cases of bone metastases. These bony lesions have increased signal intensity in T2-weighted and low signal intensity on T1-weighted images, with intense homogeneous enhancement. However, on MR imaging, we were unable to find necrosis or compression deformity of the vertebrae, despite extensive metastatic disease.


Bone Marrow Neoplasms/secondary , Brain Neoplasms/pathology , Oligodendroglioma/diagnosis , Oligodendroglioma/secondary , Adult , Bone Marrow Neoplasms/diagnosis , Brain Neoplasms/diagnosis , Humans , Immunohistochemistry , Magnetic Resonance Imaging , Male , Thoracic Vertebrae
16.
AJNR Am J Neuroradiol ; 26(6): 1420-4, 2005.
Article En | MEDLINE | ID: mdl-15956509

BACKGROUND AND PURPOSE: The purpose of this study was to examine the efficacy and safety of the 6F Closer S device (Perclose; Redwood City, CA) versus manual compression to close arteriotomy sites after neurointerventional procedures in both virgin vessels and those previously treated with the device. METHODS: This single-center, multiple-operator, controlled, prospective study included 475 procedures (337 patients) with the device and 79 procedures (79 patients) with manual compression. A substantial number of patients receiving anticoagulation and/or antiplatelet medications were included. Efficacy and safety were evaluated on the basis of the rate of hemostatic success and the incidence of clinically significant complications. The literature was reviewed by using MEDLINE. RESULTS: Overall success rates were 95% in the device group versus 96% in the manual-compression group (P = 0.78), and clinically relevant complication rates were 0.6% versus 2.5%, respectively (P = 0.15). Success rates significantly declined in vessels previously treated with the device three or more times. However, complication rates did not significantly change. Literature review yielded 12 articles reporting complication rates of 3.2-35% for the device and 2.3%-33.3% for manual compression. CONCLUSION: The device was safe and effective for closing arteriotomy sites in patients undergoing neurointerventional procedures, including those receiving anticoagulation/antiplatelet therapy or those previously treated with the device one or two times.


Arteries/surgery , Hemostatic Techniques/instrumentation , Vascular Surgical Procedures/instrumentation , Female , Humans , Male , Middle Aged , Neurosurgical Procedures , Prospective Studies
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