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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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
CONCLUSION: Pathogenesis of AF is involved abnormal changes of hemostasis, endothelial dysfunction, antithrombotic state and inflammation. The homeostatic markers, which play role in these pathways, and the presence of BMBs could use to form a prognostic clinic assessment tool to predict bleeding risk. PMID: 30207930 [PubMed - as supplied by publisher]
Source: Neurological Research - Category: Neurology Tags: Neurol Res Source Type: research
ConclusionThe presence of systolic HF, defined according to an old and a new definition, does not determine safety and efficacy of cerebral iv-thrombolysis in patients with IS.
Source: Polish Journal of Neurology and Neurosurgery - Category: Neurosurgery Source Type: research
CONCLUSION: The presence of systolic HF, defined according to an old and a new definition, does not determine safety and efficacy of cerebral iv-thrombolysis in patients with IS. PMID: 30170703 [PubMed - as supplied by publisher]
Source: Neurologia i Neurochirurgia Polska - Category: Neurology Authors: Tags: Neurol Neurochir Pol Source Type: research
ConclusionsThe ENDURANCE Supplemental Trial failed to demonstrate noninferiority of HVAD versus control regarding the pre-specified primary endpoint. However, the trial confirmed that BP management is associated with reduced stroke rates in HVAD subjects. HVAD subjects, relative to control subjects, more commonly achieved the composite endpoint (freedom from death, disabling stroke, and device replacement or urgent transplantation). (A Clinical Trial to Evaluate the HeartWare™ Ventricular Assist System [ENDURANCE SUPPLEMENTAL TRIAL] [DT2]; NCT01966458)Graphical abstract
Source: JACC: Heart Failure - Category: Cardiology Source Type: research
ConclusionsOver the last two decades Polish urban stroke units may have achieved a significant reduction of the occurrence of some noninfectious complications (i.e. MI, exacerbated CHF and DVT). However, the list of conditions associated with stroke unit mortality includes not only MI and exacerbated CHF but also PE, gastrointestinal bleeding and recurrent stroke.
Source: Polish Journal of Neurology and Neurosurgery - Category: Neurosurgery Source Type: research
Continuous-flow left ventricular assist devices (CF-LVADs) decrease mortality and improve quality of life in patients with advanced heart failure (HF). Their widespread utilization has led to concerns regarding increased adverse effects, especially in women. Nevertheless, sex-specific data remain limited. We searched Medline, Embase, Scopus, and the Cochrane Library for publications reporting sex-specific outcomes after CF-LVADs from January 2008 through January 2017. Outcomes were compared under the random-effects model and heterogeneity examined via χ2 test and I2 statistics. A total of 10 studies including 4,493 CF-...
Source: ASAIO Journal - Category: Medical Devices Tags: Review Articles Source Type: research
Conclusions: Acute ischemic infarcts, particularly to the right insular cortex, can result in ECG abnormalities, such as QT prolongation and T-wave inversion, as well as acute systolic heart failure; all of which may be reversible after the acute phase of the stroke.
Source: The Neurologist - Category: Neurology Tags: Case Report/Case Series Source Type: research
AbstractPurpose of ReviewHypertensive emergency is defined as a systolic blood pressure>  180 mmHg or a diastolic blood pressure>  120 mmHg with evidence of new or progressive end-organ damage. The purpose of this paper is to review advances in the treatment of hypertensive emergencies within the last 5 years.Recent FindingsNew literature and recommendations for managing hypertensive emergencies in the setting of pregnancy, stroke, and heart failure have been published.SummaryOral nifedipine is now considered an alternative first-line therapy, along with intravenous hydralazine and labeta...
Source: Current Hypertension Reports - Category: Primary Care Source Type: research
In this study however, they didn’t assess the risk of developing diabetes, which may be because diabetes is a newer disease in the Chinese population and there is not good documentation of who has it,” Richard said. Still, she noted, “this will be very important data for helping develop dietary prevention guidelines in China.” Cardiovascular disease, which takes the lives of 17.7 million people every year, is the leading cause of death and disability worldwide, according to the World Health Organization. Cardiovascular disease causes nearly a third — 31% — of all global deaths each year....
Source: WBZ-TV - Breaking News, Weather and Sports for Boston, Worcester and New Hampshire - Category: Consumer Health News Authors: Tags: Health News Eggs Heart Disease Local TV Source Type: news
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