ISHLT 2017: Medtronic HVAD trial misses primary endpoint, reports lowered stroke rates

Medtronic (NYSE:MDT) said today that results from the Endurance supplemental trial of its HVAD heart pump system did not meet its primary endpoint, but did report  lowered stroke rates compared to standard treatment. The trial aimed to evaluate the use of the HVAD system, which it picked up along with HeartWare last year, as a destination therapy for patients who require a left ventricular assist device and received improved blood pressure management, the Fridley, Minn.-based company said. Data from the study was presented at the 2017 International Society for Heart and Lung Transplantation Scientific Meeting in San Diego. Medtronic said that the Endurance trial did not meet its primary endpoint of all neurologic events at 12 months, but that secondary results indicated a 76.4% survival rate on the originally implanted device without disabling stroke. The control arm reported a 66.9% rate, comparatively. “In the Endurance trial, we were concerned about the higher rate of stroke in the HVAD group compared to the control. In the Endurance Supplemental trial, that gap closed and the stroke rates are comparable: there was no statistically significant difference between the HVAD and HeartMate II. We believe the narrowing of those rates was most likely due to blood pressure management,” co-principal investigator Dr. Carmelo Milano of Durham, N.C.’s Duke University Medical Center said in a press release. Patients in the HVAD arm had a higher rate of strok...
Source: Mass Device - Category: Medical Equipment Authors: Tags: Cardiac Assist Devices Cardiovascular Clinical Trials HeartWare International Inc. Medtronic Source Type: news

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Patients with end-stage heart failure on left ventricular assist devices are predisposed to stroke. Preoperative factors associated with increased stroke risk are poorly understood.
Source: The Journal of Heart and Lung Transplantation - Category: Transplant Surgery Authors: Tags: 402 Source Type: research
AbstractDebates regarding the most beneficial medical or surgical procedures for patients with spontaneous intracerebral hemorrhage (sICH) are still ongoing. We aimed to evaluate the risk of subsequent vascular disease and mortality in patients with sICH treated with and without surgical intervention, in a large-scale Asian population. Patients hospitalized within 2000 to 2013 who were newly diagnosed with sICH were identified using the National Health Insurance Research Database of Taiwan. Neuroendoscopy and craniotomy groups comprised patients who underwent surgical treatment within 1  week, while those in the contr...
Source: Neurotherapeutics - Category: Neurology Source Type: research
CONCLUSIONS: Self-reported frequent eczema was associated with increased risk of mortality from CHD, but not other major CVD, in a Japanese general population. Since steroid usage was not considered, future studies should include it as a potential confounding factor. PMID: 30700678 [PubMed - as supplied by publisher]
Source: Journal of Atherosclerosis and Thrombosis - Category: Cardiology Tags: J Atheroscler Thromb Source Type: research
Conclusions:There is a significant proportion of multimorbidity in our study population. Multimorbidity may be used as a criterion to prioritize and improve the management of patients. Measures to prevent cardiovascular disease in people who already have hypertension, diabetes or underlying causes of heart failure in primary care settings need to be emphasized. At higher levels of care, capacity building is key to addressing the management of patients who present with acute cardiovascular diseases.   [Ethiop. J. Health Dev.2018;32(4):218-224]Keywords:Cardiovascular disease, multimorbidity, mortality, intensive care
Source: Ethiopian Journal of Health Development - Category: African Health Source Type: research
Authors: Kreuziger LB, Massicotte MP Abstract Mechanical circulatory support (MCS) is the overarching term that encompasses the temporary and durable devices used in patients with severe heart failure. MCS disturbs the hematologic and coagulation system, leading to platelet activation, activation of the contact pathway of coagulation, and acquired von Willebrand syndrome. Ischemic stroke and major hemorrhage occur in up to 30% of patients. Hematologists are an essential part of the MCS team because they understand the delicate balance between bleeding and clotting and alteration of hemostasis with antithrombotic th...
Source: Hematology ASH Education Program - Category: Hematology Tags: Hematology Am Soc Hematol Educ Program Source Type: research
ConclusionsOur study elucidates the characteristics and risk factors of patients who died of ND during CF-LVAD support. Further studies are required to find ways to decrease the incidence of fatal ND during CF-LVAD support.
Source: The Annals of Thoracic Surgery - Category: Cardiovascular & Thoracic Surgery Source Type: research
The objective of this study was to evaluate the impact of heart failure (HF) etiology (ischemic cardiomyopathy [ICM] versus nonischemic cardiomyopathy) on in-hospital outcomes in patients undergoing left ventricular assist device (LVAD) placement using the Nationwide Inpatient Sample database. We identified patients who underwent LVAD placement from 2011 to 2014. The primary end point was the effect of ICM on in-hospital mortality. Secondary end points included periprocedural vascular complications requiring surgery, postoperative myocardial infarction, stroke, and hemorrhage requiring transfusion.
Source: The American Journal of Cardiology - Category: Cardiology Authors: Source Type: research
The objective of this study was to evaluate the impact of heart failure (HF) etiology (ischemic cardiomyopathy (IC) vs. non-ischemic cardiomyopathy (NIC)) on in-hospital outcomes in patients undergoing left ventricular assist device (LVAD) placement using the Nationwide Inpatient Sample (NIS) database. We identified patients who underwent LVAD placement from 2011 to 2014. The primary endpoint was the effect of ICM on in-hospital mortality. Secondary endpoints included peri-procedural vascular complications requiring surgery, post-operative myocardial infarction, stroke and hemorrhage requiring transfusion.
Source: The American Journal of Cardiology - Category: Cardiology Authors: Source Type: research
A 79-year old man with a history of myocardial infarction and coronary artery bypass grafting in 2000, biventricular systolic heart failure with an ejection fraction of 27%, hypertension, persistent atrial fibrillation for which he was taking high-dose aspirin given a previous history of hemorrhagic stroke, stage 3 chronic kidney disease, left cerebellar ischemic stroke, and implantable cardioverter-defibrillator (ICD) placement 5 years previously presented to his local medical facility with a 2-day history of breathlessness, fevers, and chills.
Source: Mayo Clinic Proceedings - Category: Internal Medicine Authors: Tags: Residents' clinic Source Type: research
Although the growing use of continuous-flow left ventricular assist devices (LVADs) has improved the survival and quality of life of patients with stage D heart failure, ischemic and hemorrhagic cerebrovascular accidents remain one of the most-feared complications of this therapy and a significant source of disability, morbidity, and mortality. In this article, the authors aim to summarize the current data regarding the incidence/prevalence of both ischemic and hemorrhagic stroke in patients with continuous-flow LVADs, compare axial and centrifugal devices, and discuss the major risk factors for neurologic events that have been identified.
Source: Cardiology Clinics - Category: Cardiology Authors: Source Type: research
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