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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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
Conclusions—Stroke is a major cause of morbidity and mortality in patients on LVAD support. Chronic obstructive pulmonary disease increases the risk of ischemic stroke, whereas dialysis may increase the risk of hemorrhagic stroke. Although any stroke increases mortality, post-LVAD hemorrhagic stroke was associated with higher mortality compared with ischemic stroke.
Source: Stroke - Category: Neurology Authors: Tags: Heart Failure, Complications, Quality and Outcomes, Intracranial Hemorrhage, Ischemic Stroke Original Contributions Source Type: research
In conclusion, a debate exists on whether aging is a disease in itself. Some authors suggest that physiological aging (or senescence) is not really distinguishable from pathology, while others argue that aging is different from age-related diseases and other pathologies. It is interesting to stress that the answer to this question has important theoretical and practical consequences, taking into account that various strategies capable of setting back the aging clock are emerging. The most relevant consequence is that, if we agree that aging is equal to disease, all human beings have to be considered as patients to be treat...
Source: Fight Aging! - Category: Research Authors: Tags: Newsletters Source Type: blogs
In conclusion, the DNPR contains data on several cardiovascular diagnoses and cardiac interventions recorded with high PPVs. Our data also suggest that a history of depression is an adverse prognostic factor for death in patients with heart failure and low LVEF. Finally, heart failure emerged as a risk factor for all-cause dementia as well as for both ischemic and hemorrhagic stroke. PMID: 29619930 [PubMed - in process]
Source: Danish Medical Journal - Category: General Medicine Tags: Dan Med J Source Type: research
There have been several clinical studies examining the factors associated with cardiovascular disease (CVD) in patients with primary aldosteronism (PA); however, their results have left it unclear whether CVD is affected by the plasma aldosterone concentration or hypokalemia. We assessed the PA database established by the multicenter JPAS (Japan Primary Aldosteronism Study) and compared the prevalence of CVD among patients with PA with that among age-, sex-, and blood pressure-matched essential hypertension patients and participants with hypertension in a general population cohort. We also performed binary logistic regress...
Source: Hypertension - Category: Cardiology Authors: Tags: Cardiovascular Disease, Risk Factors, Hypertension, Vascular Disease Original Articles Source Type: research
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