Medtronic ’s HVAD System Just Became Less Invasive

Medtronic has gained FDA approval for a less-invasive implant approach of its HVAD System, a left ventricular assist device (LVAD) for advanced heart failure patients. The Dublin-based company picked up the technology when it acquired HeartWare in 2016. The firm said the technology is the only LVAD approved in the U.S. for implant via thoracotomy, a small lateral, surgical incision between the patient's ribs on the left side of the chest. FDA approval for HVAD implantation via thoracotomy is based on data from the LATERAL prospective clinical trial, in which 144 patients, with end-stage heart failure who were eligible for heart transplant, were enrolled at 26 centers in the U.S. and Canada. The primary endpoint of the trial demonstrated non-inferiority of the HVAD implanted in patients via thoracotomy, where survival at six months free from disabling stroke or device explant or exchange due to malfunction was achieved in 88.1% of patients. Since the success outcome exceeded the pre-specified performance goal of 77.5%, the trial achieved its primary endpoint (p=0.0012). The key secondary endpoint revealed a significant reduction in total length of hospital stay, from an average of 26.1 days down to 18 days (p
Source: MDDI - Category: Medical Devices Authors: Tags: Cardiovascular Business Source Type: news

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AbstractAlterations of normal intra- and interatrial conduction are a common outcome of multiple cardiovascular conditions. They arise most commonly in the context of advanced age, cardiovascular risk factors, organic heart disease, atrial fibrosis, and left atrial enlargement. Interatrial block (IAB), the most frequent and extensively studied atrial conduction disorder, affects up to 20% of the general primary care population. IAB can be partial (P wave duration ≥ 120 ms on any of the 12 ECG leads) or advanced (P wave ≥ 120 ms and biphasic morphology (positive-negative) in inferior leads). Ad...
Source: Journal of Interventional Cardiac Electrophysiology - Category: Cardiology Source Type: research
ConclusionsEmbolism is a major problem encountered by patients under LVAD support while waiting for an HT. Thrombectomy for AIS associated with LVAD support is a useful and safe treatment modality. It is possible to maintain a reasonable mRS score in patients who are not completely independent.
Source: Acta Neurochirurgica - Category: Neurosurgery Source Type: research
ConclusionNLR predicts all-cause mortality, MACE, and HF hospitalization 1-year post-TAVR. NLR with TAVR risk score improved predictability for MACE. Further studies for prognostication utilizing NLR are warranted.
Source: Indian Heart Journal - Category: Cardiology 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
AbstractPurposeTo investigate risk factors for stroke in patients initiating oral anticoagulants for atrial fibrillation in Norway and their association with receiving DOACs versus warfarin.MethodsFrom nationwide registries, we identified na ïve users initiating treatment with warfarin, dabigatran, rivaroxaban, or apixaban for atrial fibrillation from 2010 to 2015 in Norway. We studied temporal changes in the CHA2DS2-VASc score and its component risk factors. We used multiple logistic regressions to identify CHA2DS2-VASc risk factors associated with receiving DOACs versus warfarin in 2015.ResultsFrom 2010 to 2015, the...
Source: European Journal of Clinical Pharmacology - Category: Drugs & Pharmacology Source Type: research
A growing number of studies suggest that getting a handle on a few key risk factors can bring type 2 diabetes under control. Lowering blood sugar, for instance, reduces the risk of additional health problems, such as heart disease and stroke related to the disease. But most of these studies have focused on studying one risk factor — like blood sugar, cholesterol or blood pressure — at a time. In a new study published in the New England Journal of Medicine, researchers analyzed what happens to death rates and other health problems when people control up to five known risk factors for type 2 diabetes. The study ...
Source: TIME: Health - Category: Consumer Health News Authors: Tags: Uncategorized healthytime medicine Source Type: news
Authors: Ibe T, Wada H, Sakakura K, Ito M, Ugata Y, Yamamoto K, Taniguchi Y, Momomura SI, Fujita H Abstract Recently, long-term outcomes of pre-capillary pulmonary hypertension (PH) have been improved, whereas morbidity and mortality are still high because of right-sided heart failure (HF). Right-sided HF is closely related to right ventricular (RV) function and hemodynamics such as RV stroke work index (RVSWI). However, the association between RVSWI and long-term outcomes in pre-capillary PH has not been well investigated. The aims of this study were to compare clinical characteristics between low RVSWI and high R...
Source: International Heart Journal - Category: Cardiology Tags: Int Heart J Source Type: research
ConclusionsIn patients with T2D and persistent microalbuminuria, u-KIM-1, but not u-NGAL, was an independent risk factor for decline in eGFR, CVE and all-cause mortality, and contributed significant discrimination for all-cause mortality, beyond traditional risk factors.
Source: Acta Diabetologica - Category: Endocrinology Source Type: research
ConclusionsICM either revealed progression of 1st-degree AV block to a higher grade block (53%) or detected an already existing more severe bradycardia warranting an IPG in 40.5% patients. This finding supports the conclusion that 1st-degree AV block might be a risk marker for more severe intermittent conduction disease and is not benign in all patients. Further studies may reveal patient subgroups which are at risk for demonstrating or developing higher grade AV block and may warrant a future IPG implantation.
Source: Journal of Interventional Cardiac Electrophysiology - Category: Cardiology Source Type: research
Publication date: 11–17 August 2018Source: The Lancet, Volume 392, Issue 10146Author(s): Araz Rawshani, Naveed Sattar, Stefan Franzén, Aidin Rawshani, Andrew T Hattersley, Ann-Marie Svensson, Björn Eliasson, Soffia GudbjörnsdottirSummaryBackgroundPeople with type 1 diabetes are at elevated risk of mortality and cardiovascular disease, yet current guidelines do not consider age of onset as an important risk stratifier. We aimed to examine how age at diagnosis of type 1 diabetes relates to excess mortality and cardiovascular risk.MethodsWe did a nationwide, register-based cohort study of individuals wi...
Source: The Lancet - Category: General Medicine Source Type: research
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