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Analysis of Trends and Outcomes of 90 and 180 Day Readmissions After Left Ventricular Assist Device Implantation
Despite decreasing morbidity and mortality in left ventricular assist device (LVAD) recipients, readmission after implantation remains a major problem. Our aim was to investigate the trends and outcomes of 90 and 180 day readmission in this population. The National Readmission Database from 2012 to 2017 was queried to identify LVAD recipients. A total of 5,907 adults (90 day readmissions) and 3,653 adults (180 day readmissions) who survived LVAD implantation during the index admission were included in our analysis. Readmissions occurred in 45.6% and 65.1% by 90 and 180 days, respectively, with most readmissions occurring w...
Source: ASAIO Journal - February 27, 2022 Category: Medical Devices Tags: Adult Circulatory Support Source Type: research

Axillary or Subclavian Impella 5.0 Support in Cardiogenic Shock: A Systematic Review and Meta-analysis
Summary data around survival and adverse events of cardiogenic shock (CS) patients supported with axillary or subclavian artery 5.0 Impella are presently unavailable. We performed a systematic search of studies reporting the outcomes of axillary or subclavian access 5.0 Impella for refractory CS in PubMed, EMBASE, and the Cochrane Library. The primary outcome was 30-day survival. Secondary outcomes included survival to next therapy and adverse events on support. Proportional meta-analysis was used to pool across studies. Of the 795 potential studies identified, 13 studies were included in the meta-analysis (n = 256 pat...
Source: ASAIO Journal - February 1, 2022 Category: Medical Devices Tags: Adult Circulatory Support Source Type: research

Impact of COVID-19 on Patients Supported with a Left Ventricular Assist Device
Patients on left ventricular assist device (LVAD) support may be susceptible to severe disease and complications from coronavirus disease-19 (COVID-19). The purpose of this study was to describe the clinical course of COVID-19 in LVAD patients. A retrospective review was performed at our center; 28 LVAD patients who developed COVID-19 between March 2020 and March 2021, and six patients with a prior COVID-19 infection who underwent LVAD implantation, were identified and examined. Of the 28 patients, nine (32%) died during the study period, five (18%) during their index hospitalization for COVID-19. Two patients (7%) present...
Source: ASAIO Journal - November 1, 2021 Category: Medical Devices Tags: Management of COVID-19 Patients Source Type: research

Ischemic Stroke and Intracranial Hemorrhages During Impella Cardiac Support
Impella is a percutaneously placed, ventricular assist device for short-term cardiac support. We aimed to study acute neurologic complications during short-term cardiac support with Impella. We reviewed prospectively collected data of 79 consecutive persons implanted with Impella at a single tertiary center. Acute neurologic events (ANE) were defined as ischemic strokes or intracranial hemorrhages. Among those with ANE, specific causes of ischemic and hemorrhagic events were collected and discussed. Of 79 persons with Impella with median 8 days of support (range 1–33 days), six (7.5%) developed ANE at a median of 5 days ...
Source: ASAIO Journal - July 30, 2020 Category: Medical Devices Tags: Case Report Source Type: research

The WATCHMAN left atrial appendage closure device for patients with atrial fibrillation: current status and future perspectives.
Authors: Wintgens LIS, Maarse M, Swaans MJ, Rensing BJWM, van Dijk VF, Boersma LVA Abstract INTRODUCTION: Atrial fibrillation (AF) is associated with an increased risk of stroke. Stroke prevention with oral anticoagulation (OAC) is recommended in AF patients at increased risk of stroke. The left atrial appendage (LAA) is the main source of thrombus formation in AF patients. The WATCHMAN percutaneous LAA closure (LAAC) device may serve as an alternative to OAC overcoming disadvantages including the risk of (major) bleeding. AREAS COVERED: This review will focus on LAAC with the Watchman device for stroke prevent...
Source: Expert Review of Medical Devices - June 18, 2020 Category: Medical Devices Tags: Expert Rev Med Devices Source Type: research

Fibrinogen Albumin Ratio and Ischemic Stroke During Venoarterial Extracorporeal Membrane Oxygenation
Fibrinogen is a clotting factor and a major determinant of platelet aggregation. Albumin, on the other hand, inhibits platelet function and thrombus formation. Taken together, an elevated fibrinogen albumin ratio (FAR) has been described as a marker of disease severity during prothrombotic conditions. We evaluated the association of FAR and ischemic stroke during venoarterial extracorporeal membrane oxygenation (VA ECMO) support. A single center, retrospective study was performed including all adult patients placed on VA ECMO. FAR was calculated from fibrinogen and albumin measurements in the first 24 hours of VA-ECMO init...
Source: ASAIO Journal - February 28, 2020 Category: Medical Devices Tags: Adult Circulatory Support Source Type: research

What Causes LVAD-Associated Ischemic Stroke? Surgery, Pump Thrombosis, Antithrombotics, and Infection
Acute ischemic stroke (AIS) is a major complication in left ventricular assist device (LVAD) population. A better understanding of clinical risk factors associated with AIS may help mitigate risk of stroke. We reviewed prospectively collected data of 477 LVAD patients from a tertiary center from October 1, 2004 to December 31, 2016. Supplemental data abstraction was performed on patients with AIS. Fifty-seven (12%) developed 61 AIS. Of 61, 17 (28%) AIS occurred perioperatively. The median time from implant to perioperative AIS was 5 days (interquartile range: 3–9). Pump thrombosis accounted for 19 (31%) of 61 AIS, and 7 ...
Source: ASAIO Journal - November 1, 2019 Category: Medical Devices Tags: Adult Circulatory Support Source Type: research

Preclinical Evaluation of the EVAHEART 2 Centrifugal Left Ventricular Assist Device in Bovines
The EVAHEART 1 left ventricular assist device was miniaturized to the EVAHEART 2, with a new inflow cannula designed to mitigate the risks of malposition. To evaluate the safety of the new double-cuff tipless inflow cannula, in vivo studies were performed in healthy bovines. Eight consecutive studies were done: five short-term studies of hematological adaptation and three long-term studies of tissue adaptation. Each inflow cannula was purposefully implanted in the worst-case setting with marked malposition. Two studies terminated early: one because of an animal-specific ancillary component and one because of an accidental ...
Source: ASAIO Journal - November 1, 2019 Category: Medical Devices Tags: Adult Circulatory Support Source Type: research

Sky Medical Technology Nabs FDA Clearance for VTE Device
Sky Medical Technology Ltd. won FDA clearance for a device that stimulates calf muscles to prevent venous thrombosis in non-surgical patients at risk for venous thromboembolism. The Daresbury, England-based company said the geko device is the first muscle pump activator of its kind to be cleared by FDA for VTE prevention across all patients. Sky Medical Technology’s geko is a non-invasive battery-powered, wearable therapy device that is about the size of wristwatch. The technology is worn at the knee. Geko works by gently stimulating the common peroneal nerve, activating the calf and foot muscle pumps, re...
Source: MDDI - October 12, 2019 Category: Medical Devices Authors: Omar Ford Tags: Business Source Type: news

Boston Scientific ’s Shining Moment at TCT
Perhaps one of Boston Scientific’s greatest moments at the 31st Transcatheter Cardiovascular Therapeutics (TCT), the annual scientific symposium of the Cardiovascular Research Foundation, came when the company announced primary endpoint results from the EVOLVE Short DAPT clinical trial. The Marlborough, MA-based company said the trial evaluated its Synergy Bioabsorbable Polymer (BP) stent and that the EVOLVE is first prospective study initiated in the U.S. to examine the safety of a shortened duration of dual antiplatelet therapy (DAPT) in patients at high risk for bleeding. Results and demonstrated that ...
Source: MDDI - September 30, 2019 Category: Medical Devices Authors: Omar Ford Tags: Cardiovascular Source Type: news

Management of Antiplatelet Therapy During Continuous-Flow Left Ventricular Assist Device Support After Thrombotic Hemorrhagic Events
Hemorrhagic or thrombotic events are common complications in heart failure patients with continuous-flow left ventricular assist device (CF-LVAD) support. Aim of this study is to investigate the effect of change in antiplatelet therapy after thrombotic or hemorrhagic events in patients with CF-LVAD support. A total of 231 CF-LVAD patients were included in this study. Patients with CF-LVAD were categorized into three groups: (1) high antiplatelet regimen as control group (aspirin [ASA] 325 mg; n = 115), (2) low antiplatelet regimen (ASA 81 mg; n = 82), started after hemorrhagic complications, and (3) double antiplatelet...
Source: ASAIO Journal - September 1, 2019 Category: Medical Devices Tags: Adult Circulatory Support Source Type: research

Atrial Fibrillation Is Not Associated With Thromboembolism in Left Ventricular Assist Device Patients: A Systematic Review and Meta-Analysis
Atrial fibrillation (AF) is a well-established risk factor of thromboembolism (TE). Thromboembolism is one of the most common complications in patients supported by continuous-flow left ventricular assisted devices (CF-LVADs). However, the association between AF and TE complications in this population is controversial. We conducted a systematic review and meta-analysis to assess the association between AF and overall TE, stroke, and device thrombosis events in CF-LVAD patients. We performed a comprehensive literature search through September 2017 in the databases of MEDLINE and EMBASE. Included studies were prospective or ...
Source: ASAIO Journal - July 1, 2019 Category: Medical Devices Tags: Adult Circulatory Support Source Type: research

Shear-Mediated Platelet Activation Enhances Thrombotic Complications in Patients With LVADs and Is Reversed After Heart Transplantation
This study provides further insight into our understanding of the pathogenesis of LVAD thrombosis, addressing SMPA as a relevant key factor associated with thrombotic complications. With the PAS assay, we have identified a reliable biomarker to promote tailored pharmacological therapy for the prevention of thromboembolic events in patients with LVADs.
Source: ASAIO Journal - April 30, 2019 Category: Medical Devices Tags: Case Reports Source Type: research

Long-term safety and efficacy of combined percutaneous LAA and PFO/ASD closure: a single-center experience (LAAC combined PFO/ASD closure).
CONCLUSIONS: LAAC combined with PFO/ASD closure might be an ideal choice to prevent stroke and other thrombotic complications in patients with both NVAF and PFO/ASD. PMID: 30999776 [PubMed - as supplied by publisher]
Source: Expert Review of Medical Devices - April 20, 2019 Category: Medical Devices Tags: Expert Rev Med Devices Source Type: research

Conformal Medical launches LAA seal study
Conformal Medical said yesterday that it launched an investigational device exemption trial for a device designed to seal off the heart’s left atrial appendage to help prevent stroke in atrial fibrillation patients. Nashua, N.H.-based Conformal’s device is designed to adapt to the each patient’s individual physiology, to be easier to implant with less imaging and without general anesthesia. The 45-patient, single-arm study is designed to evaluate the device’s performance, with an estimated primary completion date of April 2020 and a final completion date of June 2025, according to ClinicalTrials.gov. Th...
Source: Mass Device - April 10, 2019 Category: Medical Devices Authors: Brad Perriello Tags: Cardiac Implants Clinical Trials Featured Conformal Medical Source Type: news

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