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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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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
Authors: Manaktala R, Kluger J Abstract Patients with atrial fibrillation are at increased risk of having a cardioembolic stroke. The use of oral anticoagulation is now well established to prevent strokes in patients with atrial fibrillation and a CHA2DS2-VASc (congestive heart failure, hypertension, age ≥75 years [2 points], diabetes mellitus, prior stroke/transient ischemic attack or thromboembolism [2 points], vascular disease, age 65 to 74 years, and sex category) score of greater than 1, beyond sex. However, the role of antiplatelet therapy, specifically aspirin in low-risk patients or as an alternative to ...
Source: Journal of the American Osteopathic Association - Category: Complementary Medicine Tags: J Am Osteopath Assoc Source Type: research
In conclusion, we have developed an effective PILs strategy to deliver the AUF1 plasmid to a specific target, and this system may be useful for the development of new anti-aging drugs. Considering the Evidence for Vascular Amyloidosis as a Cause of Aging https://www.fightaging.org/archives/2017/11/considering-the-evidence-for-vascular-amyloidosis-as-a-cause-of-aging/ The balance of evidence for the aging of the cardiovascular system suggests the following view. It starts off in the blood vessels, with the accumulation of senescent cells and cross-links. Cross-links directly stiffen these tissues, while ...
Source: Fight Aging! - Category: Research Authors: Tags: Newsletters Source Type: blogs
ConclusionsOur findings are largely compatible with the results of LVSD or HF subgroups in RE‐LY, ROCKET‐AF, and ARISTOTLE trials and add to increasing confidence that DOACs can be safely used for stroke and systemic embolism prevention in patients with LVSD.
Source: Clinical Cardiology - Category: Cardiology Authors: Tags: CLINICAL INVESTIGATIONS Source Type: research
ConclusionsCompared with patients without CKD, among incident heart failure patients without atrial fibrillation, CKD both with and without dialysis was associated with a higher rate of major bleeding and all‐cause death. Only CKD‐no RRT was associated with a higher rate of ischaemic stroke and intracranial bleeding.
Source: ESC Heart Failure - Category: Cardiology Authors: Tags: Original Research Article Source Type: research
The HeartWare Ventricular Assist System (HVAD) provides significant improvements in survival and quality of life, and here, we seek to evaluate temporal differences in the adverse event (AE) rates. Patients (n = 382) in the ADVANCE bridge-to-transplant and continued access protocol trial were assessed for bleeding, cardiac arrhythmia, infection, ischemic and hemorrhagic stroke, and right heart failure during predetermined time periods (≤30,>30–180,>180–365,>365–730,>730–1,095 days) after HVAD implant. The Kaplan–Meier survival at 30 days, 6 months, 1, 2, and 3 years was 98%, 90%...
Source: ASAIO Journal - Category: Medical Devices Tags: Adult Circulatory Support Source Type: research
AbstractPurpose of ReviewThe purpose of this review is to describe the current knowledge in prevention and treatment of thrombotic (pump thrombosis and ischemic stroke) and bleeding (gastrointestinal and hemorrhagic stroke) complications in patients supported by continuous-flow left ventricular assist devices (CF-LVAD).Recent FindingsLeft ventricular assist devices (LVADs) are now widely used for the management of end-stage heart failure. Unfortunately, in spite of the indisputable positive impact LVADs have on patients, the frequency and severity of complications are limitations of this therapy. Stroke, pump thrombosis, a...
Source: Current Heart Failure Reports - Category: Cardiology Source Type: research
CONCLUSION: Oral anticoagulation was significantly underused in NVAF patients in China. Age, sex, concurrent drug usage and disease history were associated factors. Improving warfarin adherence was promising to reduce ischemic stroke risk of NVAF patients. PMID: 29022745 [PubMed - as supplied by publisher]
Source: Current Medical Research and Opinion - Category: Research Tags: Curr Med Res Opin Source Type: research
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