EBR Systems launches trial for wireless pacer

EBR Systems said yesterday that it launched a 350-patient investigational device exemption trial of its Wise wireless pacemaker it hopes to use to win FDA approval. Sunnyvale, Calif.-based EBR’s device uses a subcutaneous generator to wirelessly deliver ultrasound energy to a “pellet” implanted in the right ventricle, which it uses to synchronize the left and right ventricles. The system is designed to eliminate the need for a left ventricular lead by allowing the operating physician to place the stimulation “pellet” in a patient-specific location inside the left ventricle. The FDA approved the Solve-CRT study back in September 2016. The randomized, double blinded pivotal trial will compare treatment with the Wise device to a sham procedure in which the device is implanted but not activated in patients who failed to respond to or are otherwise unable to receive conventional cardiac resynchronization therapy, according to ClinicalTrials.gov. The primary safety outcome is freedom from procedure- and device-related complications at six months, including electrode  dislodgement, migration or malfunction; vascular complications from the procedure; transmitter/battery pocket complications; and stroke/transient ischemic attack. Solve-CRT has three primary endpoints, all at six months: mean change in left ventricular end systolic volume; the percentage of subjects with an improvement of greater than 15% in LVESV; and a composite improvement mea...
Source: Mass Device - Category: Medical Devices Authors: Tags: Cardiovascular Clinical Trials Cardiac Rhythm Management EBR Systems Inc. Source Type: news

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Left ventricular assist devices (LVAD) are widely used as a support strategy for advanced heart failure. Complications such as thrombosis and bleeding have been linked to LVAD. We observed that LVAD implantation was followed by a sharp increase in serum levels of IgG natural antibodies (Nabs) recognizing oxidation-specific epitopes (OSE) and apoptotic cells. Nabs have been implicated in inflammatory reactions related to atherosclerosis, ischemic stroke and primary graft dysfunction following heart transplantation.
Source: The Journal of Heart and Lung Transplantation - Category: Transplant Surgery Authors: Tags: (1211) Source Type: research
Mechanical circulatory support systems for cardiogenic shock and heart failure are associated with ischemic strokes and intracranial hemorrhages. Impella is a percutaneously placed, ventricular assist device for short-term cardiac support. We aimed to study the prevalence of acute neurologic complications during short-term support with Impella.
Source: The Journal of Heart and Lung Transplantation - Category: Transplant Surgery Authors: Tags: (994) Source Type: research
This study included 1962 patients who underwent transesophageal echocardiographic examination (TEE) prior to cardioversion or ablation in the years 2014-2018 in three cardiac centers. RESULTS: More than a quarter of AF patients had decreased eGFR (
Source: Cardiology Journal - Category: Cardiology Authors: Tags: Cardiol J Source Type: research
AbstractDespite a higher risk of ischemic stroke in hospitalized patients with acute heart failure (HF), little is known about the risk of ischemic stroke during the post-discharge phases of HF. Here we investigated (1) the ischemic stroke incidence rate during the post-discharge phases among HF patients receiving standard treatments; (2) the association between ischemic stroke incidence and clinical background, including cardiac structure and function. Among 950 patients who required hospitalization for HF (median duration: 19 days) at our institution, where they received standard treatments, we investigated stroke occurr...
Source: Heart and Vessels - Category: Cardiology Source Type: research
AbstractAimsPatients with chronic heart failure (CHF) have an increased risk of ischaemic stroke. We aimed to identify the incidence rate and factors associated with ischaemic stroke or transient ischaemic attack (TIA) in CHF patients as well as the impact of non ‐invasive telemedical care (NITC) on acute stroke/TIA.Methods and resultsWe retrospectively analysed baseline characteristics of 2248 CHF patients enrolled to the prospective multicentreTelemedical Interventional Monitoring in Heart Failure study (TIM ‐HF) andTelemedical Interventional Management in Heart Failure II study (TIM ‐HF2), randomizing New York Hea...
Source: ESC Heart Failure - Category: Cardiology Authors: Tags: Original Research Article Source Type: research
Authors: Shen Y, Wang J, Chen H, Li M, Chen M Abstract Background: Renal impairment and atrial fibrillation (AF) often coexist. However, risk factors associated with renal impairment in AF patients have not been studied in a large population. Accordingly, this study investigated clinical factors associated with renal impairment in AF patients.Methods: From January 2012 to December 2016, 2,298 inpatients with non-valvular AF (NVAF) mainly for catheter ablation were enrolled in this cross-sectional study. Data collection included past medical history, echocardiography measurements, current medicine use and biochemica...
Source: Postgraduate Medicine - Category: Internal Medicine Tags: Postgrad Med Source Type: research
ner Pikija Intracranial artery calcification can be detected on nonenhanced brain computer tomography (NECT) and is a predictor of early vascular events. Here, we assessed the impact of vertebrobasilar artery calcification (VBC) on the long-term risk for recurrent stroke and vascular events. We performed a case-control trial of all consecutive stroke patients admitted to the University Hospital of Maribor, Slovenia over a period of 14 months. VBC was defined as presence of a hyperdense area within vertebrobasilar arteries that exceeds > 90 Hounsfield units as seen on NECT. Clinical follow-up information was o...
Source: International Journal of Environmental Research and Public Health - Category: Environmental Health Authors: Tags: Article Source Type: research
Abstract BACKGROUND: Stroke is a major complication following cardiac surgery causing increased morbidity and mortality. There are limited data on outcomes of patients with large vessel occlusion (LVO) following cardiac surgery. METHODS: Patients who underwent index cardiac surgeries (as defined by the STS) from 2010 to 2017 were reviewed from a prospectively maintained database. All patients with neurologic deficits were identified and only patients with ischemic strokes were included. RESULTS: A total of 10,250 underwent cardiac surgical procedures. Post-operative stroke with neurological deficits occu...
Source: The Annals of Thoracic Surgery - Category: Cardiovascular & Thoracic Surgery Authors: Tags: Ann Thorac Surg Source Type: research
Conclusion: BMI has a nonlinear relationship with 1-year unplanned readmission in patients with myocardial infarction. The 1-year unplanned readmission rate of overweight patients (BMI > 29.3 kg/m2) has increased significantly. Obesity paradox does not exist in terms of readmission of Chinese patients with myocardial infarction after PCI. PMID: 32148951 [PubMed]
Source: Cardiology Research and Practice - Category: Cardiology Authors: Tags: Cardiol Res Pract Source Type: research
CONCLUSIONS: Low ASMI is independently associated with poor outcome in patients with STEMI. PMID: 32132340 [PubMed - as supplied by publisher]
Source: Journal of Atherosclerosis and Thrombosis - Category: Cardiology Tags: J Atheroscler Thromb Source Type: research
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