Medtronic Pipeline Embolization Device Found Safe For Smaller Aneurysms

MedicalResearch.com Interview with:

Ricardo A Hanel, MD PhD Endovascular and Skull Base Neurosurgery Director, Baptist Neurological Institute Endowed Chair, Stroke and Cerebrovascular Surgery Jacksonville, FL

Dr. Hanel

Ricardo A Hanel, MD PhD
Endovascular and Skull Base Neurosurgery
Director, Baptist Neurological Institute
Endowed Chair, Stroke and Cerebrovascular Surgery
Jacksonville, FL

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: Medtronic Pipeline Embolization Device has been approved for carotid artery aneurysms over 10mm in size, from the petrous to clinoid segment but given the efficacy of results on these larger lesions, it has been widely utilized for treatment of smaller lesions. PREMIER came from the need of assessing the results , safety and efficacy, of pipeline for use of aneurysms under 12mm, located on the carotid artery, all segments, and V3 segment of the vertebral artery.
PREMIER enrolled 141 patients treated at 22 centers (21 US, 1 Canada). Primary Safety effectiveness defined as total aneurysm occlusion, core lab adjudicated , at 1 year was 83.5%; with safety endpoint of major stroke/death at 30 days of 1.4% (2 patients), with 1-year major stroke and death rate of 2.1%.

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More Surgeries, Fewer Deaths From Abdominal Aortic Aneurysms in US than UK

MedicalResearch.com Interview with:

Alan Karthikesalingam MD PhD, NIHR Academic Clinical Lecturer in Vascular Surgery St George's Vascular Institute London, UK

Dr. Alan Karthikesalingam

Alan Karthikesalingam MD PhD, NIHR
Academic Clinical Lecturer in Vascular Surgery
St George’s Vascular Institute
London, UK

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: The background for this study was that the typical diameter at abdominal aortic aneurysm (AAA)  repair, and the population incidence of AAA repair, have been known to vary considerably between different countries. This study aimed to observe whether a discrepancy in the population incidence rate of AAA repair between England and the USA was seen alongside a discrepancy in population rates of AAA-related mortality or AAA rupture in those countries.

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Unruptured Brain Arteriovenous Malformations: Treat or Leave Alone?

MedicalResearch.com Interview with:

Christian Stapf, MD Full Professor, Department of Neurosciences Université de Montréal Principal Scientist, CRCHUM Montréal Canada

Dr. Christian Stapf

Christian Stapf, MD
Full Professor, Department of Neurosciences
Université de Montréal
Principal Scientist, CRCHUM
Montréal Canada 

Medical Research: What is the background for this study?

Dr. Stapf: Brain arteriovenous malformations are abnomal tangles of falsely linked arteries and veins in the brain. They may be asymptomatic, or lead to headaches, epileptic seizures or – worst case – to stroke, usually by intracranial hemorrhage. Brain AVMs are relatively rare, but approximately 5000 patients are discovered every year in the U.S.and Canada, 3000 of whom will have an unruptured malformation at the diagnosis.

The ARUBA trial tested if it was better to remove an unruptured  Brain arteriovenous malformations in order to prevent death and stroke, or if patients were better off living with an AVM without undergoing intervention.

Medical Research: What are the main findings?

Dr. Stapf:  The trial results showed that an initially unruptured Brain arteriovenous malformations if left untreated may lead to hemorrhage in 2.1% every year. However this risk increases by the factor 4.5, if you start treating the AVM for attempted eradication. The risk of developing a significant neurological deficit also increase by the factor 2.5 after treatment, and there was no benefit for epileptic seizures or headaches.

Medical Research: What should clinicians and patients take away from your report?

Dr. Stapf: Living with an unruptured brain  Brain arteriovenous malformations is far safer than to attempt interventional therapy. This is true when looking at all interventional treatment types (surgery, embolization or radiotherapy). Leaving an unruptured AVM untreated reduces the risk of death and stroke by 78%.

Medical Research: What should clinicians and patients take away from your report?

Dr. Stapf: Preventive intercventions in patients diagnosed with an unruptured brain AVM are potentially dangerous, and cannot safely be recommended based on current knowledge. We have to find safer ways to treat these lesions without adding more harm.

Medical Research: What recommendations do you have for future research as a result of this study?

Dr. Stapf: The trial was funded by NIH/NINDS and patients were enrolled at specialized Treatment Centers across the U.S., Canada, Brazil, South Corea, and eight European countries.

Citation: Presented at 2016 ISC Conference February 2016

Carotid Endarterectomy versus Stenting for Treatment of Carotid Artery Stenosis: Long-term Results of the Carotid Revascularization Endarterectomy vs. Stenting Trial (CREST)

 

Abdominal Aortic Aneurysms: What Are Risk Factors For Expansion

Rachel Bhak MS Department of Veterans Affairs Cooperative Studies Program Coordinating Center West Haven, ConnecticutMedicalResearch.com Interview with:
Rachel Bhak MS
Department of Veterans Affairs Cooperative Studies Program Coordinating Center
West Haven, Connecticut

Medical Research: What is the background for this study? What are the main findings?

Ms. Bhak: Abdominal aortic aneurysms (AAA) and their rupture are potentially fatal, so monitoring and understanding their expansion is of utmost importance. This study sought to characterize factors associated with Abdominal aortic aneurysms expansion, as well as their different growth patterns. The main findings are that current smoking and diastolic blood pressure are associated with increased linear expansion rate, diabetes with a decreased linear expansion rate, and diastolic blood pressure and baseline abdominal aortic aneurysms diameter with an accelerated expansion rate. Continue reading

Brain AV Malformations: Conservative Treatment May Be Best For Stable Lesions

MedicalResearch.com Interview with: Rustam Al-Shahi Salman Professor of clinical neurology and MRC senior clinical fellow, University of Edinburgh Honorary consultant neurologist, NHS Lothian upcoming JAMA publication:MedicalResearch.com Interview with:
Rustam Al-Shahi Salman
Professor of clinical neurology and MRC senior clinical fellow
University of Edinburgh
Honorary consultant neurologist, NHS Lothian


MedicalResearch.com: What are the main findings of the study?

Prof. Al-Shahi Salman: Patients with arteriovenous malformations (abnormal connection between arteries and veins) in the brain that have not ruptured had a lower risk of stroke or death for up to 12 years if they received conservative management of the condition compared to an interventional  treatment.

Interventional treatment for brain arteriovenous malformations (bAVMs)
with procedures such as neurosurgical excision, endovascular
embolization, or stereotactic radiosurgery can be used alone or in
combination to attempt to obliterate bAVMs. Because interventions may
have complications and the untreated clinical course of unruptured
bAVMs can be benign, some patients choose conservative management (no
intervention). Guidelines have endorsed both intervention and
conservative management for unruptured brain arteriovenous malformations. Whether conservative management is superior to interventional treatment for unruptured
bAVMs is uncertain because of the lack of long-term experience,
according to background information in the article.

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