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Landmark Phase 3 VOYAGER PAD Study of XARELTO ® (rivaroxaban) Plus Aspirin Shows Significant Benefit in Patients with Symptomatic Peripheral Artery Disease (PAD) after Lower-Extremity Revascularization
RARITAN, NJ, March 28, 2020 – The Janssen Pharmaceutical Companies of Johnson & Johnson today announced the VOYAGER PAD study met its primary efficacy and principal safety endpoints, demonstrating the XARELTO® (rivaroxaban) vascular dose (2.5 mg twice daily) plus aspirin (100 mg once daily) was superior to aspirin alone in reducing the risk of major adverse limb and cardiovascular (CV) events by 15 percent in patients with symptomatic peripheral artery disease (PAD) after lower-extremity revascularization, with similar rates of TIMI[1] major bleeding. VOYAGER PAD is the only study to show a significant benefit using...
Source: Johnson and Johnson - March 28, 2020 Category: Pharmaceuticals Tags: Innovation Source Type: news

Janssen Highlights Continued Commitment to Cardiovascular & Metabolic Healthcare Solutions with Late-Breaking Data at the First Fully Virtual American College of Cardiology Scientific Session
RARITAN, N.J., March 20, 2020 – The Janssen Pharmaceutical Companies of Johnson & Johnson announced today that it will unveil late-breaking data from its leading cardiovascular and metabolism portfolio during the virtual American College of Cardiology’s 69th Annual Scientific Session together with the World Congress of Cardiology (ACC.20/WCC) on March 28-30, 2020. Notably, four late-breaking abstracts for XARELTO® (rivaroxaban) will be presented, including data from the Phase 3 VOYAGER PAD study in patients with symptomatic peripheral artery disease (PAD) after lower-extremity revascularization.Click to Tweet: Jan...
Source: Johnson and Johnson - March 20, 2020 Category: Pharmaceuticals Source Type: news

Left ventricular assist systems and strokes: Statins to the rescue?
The development of durable left ventricular assist systems (LVASs) has been critical in providing an option for management of end-stage heart disease and addressing the increasing gap between demand and supply of donor cardiac allografts for management of end-stage heart disease. The technology also provides an alternative to heart transplantation in many patients. Unfortunately, the long-term use of LVASs has been associated with significant morbidities, the most devastating of which may relate to the thrombogenicity of the artificial devices, leading to ischemic stroke or pump thrombosis.
Source: The Journal of Heart and Lung Transplantation - March 16, 2020 Category: Transplant Surgery Authors: Jignesh K. Patel Tags: EDITORIAL COMMENTARY Source Type: research

Left Ventricular Assist Systems and Strokes- Statins to the Rescue?
The development of durable left ventricular assist systems (LVAS) has been critical in providing an option for management of end-stage heart disease and addressing the increasing gap between demand and supply of donor cardiac allografts for management of end-stage heart disease. The technology also provides an alternative to heart transplantation in many patients. Unfortunately, the long-term use of LVAS has been associated with significant morbidities, the most devastating of which may relate to the thrombogenicity of the artificial devices, leading to ischemic stroke or pump thrombosis.
Source: The Journal of Heart and Lung Transplantation - March 16, 2020 Category: Transplant Surgery Authors: Jignesh Patel Tags: Editorial Source Type: research

Permanent Implantable Cardiac Support Systems.
CONCLUSION: A VAD system can be implanted as an alternative to cardiac transplan- tation or as a bridging treatment until the patient can be listed for transplantation and receive the transplant. Because of the organ s , only a minority of VAD patients ever receive a transplant. PMID: 31931951 [PubMed - in process]
Source: Deutsches Arzteblatt International - January 16, 2020 Category: General Medicine Tags: Dtsch Arztebl Int Source Type: research

Bleeding in critical care associated with left ventricular assist devices: pathophysiology, symptoms, and management.
Authors: Leebeek FWG, Muslem R Abstract Chronic heart failure (HF) is a growing health problem, and it is associated with high morbidity and mortality. Left ventricular assist devices (LVADs) are nowadays an important treatment option for patients with end-stage HF not only as a bridging tool to heart transplantation but also, as a permanent therapy for end-stage HF (destination therapy). The use of LVAD is associated with a high risk for bleeding complications and thromboembolic events, including pump thrombosis and ischemic stroke. Bleeding is the most frequent complication, occurring in 30% to 60% of patients, b...
Source: Hematology ASH Education Program - December 7, 2019 Category: Hematology Tags: Hematology Am Soc Hematol Educ Program Source Type: research

Bloodstream Infections in Continuous Flow Left Ventricular Assist Device Recipients: Diagnostic and Clinical Implications
Bloodstream infection (BSI) is a common complication of left ventricular assist device (LVAD) support and particularly difficult to treat. The presentation is often variable because of altered physiology and augmentation of cardiac output by the device. We studied LVAD recipients at a single institution. Multivariate logistic and Cox (with time-varying parameters) regression were implemented. Of 212 patients, 58% experienced infections. Driveline infection (DLI) affected 31%, with 60% of them having deep-tissue involvement. Sixty-six patients (31%) suffered from 135 BSIs. Systemic inflammatory response syndrome (SIRS) was ...
Source: ASAIO Journal - November 1, 2019 Category: Medical Devices Tags: Adult Circulatory Support Source Type: research

First Human Implantation of A Miniaturized Axial Flow Ventricular Assist Device in a Child with End-Stage Heart Failure
Small children with end-stage heart failure who require left ventricular assist device (LVAD) support to heart transplant have limited device options leading to high morbidity and mortality and chronic hospitalization until transplant.1,2 The only FDA-approved durable LVAD for children is a paracorporeal pulsatile device that carries a high stroke risk and lacks portability precluding hospital discharge.1 Temporary paracorporeal continuous flow (CF) devices have also been used off-label for bridge-to-transplant but carry higher mortality, require lengthy paracorporeal cannulas prone to circuit thrombus, and typically requi...
Source: The Journal of Heart and Lung Transplantation - September 10, 2019 Category: Transplant Surgery Authors: Antonio Amodeo, Sergio Filippelli, Gianluigi Perri, Roberta Iacobelli, Rachele Adorisio, Francesca Iodice, Alessandra Rizza, M. Patricia Massicotte, J. Timothy Baldwin, Christopher S.D. Almond Tags: Case Anecdotes, Comments and Opinions Source Type: research

Bridging the Gap to LVAD Recovery and Explantation
Left ventricular assist device (LVAD) implantation continues to occur at an exceedingly high rate due to the donor and supply mismatch when it comes to heart transplantation. LVADs however do not come without risk and have high rates of significant bleeding, stroke, pump thrombosis and infection. Most of the clinical and research efforts thus far have been focused on LVAD insertion with the goal of destination therapy or as a bridge to transplant. The goal of bridge to recovery has often been underestimated despite multiple studies showing reverse remodeling of the myocardium.
Source: Journal of Cardiac Failure - July 31, 2019 Category: Cardiology Authors: Karlee K. Hoffman, Manreet Kanwar Tags: 361 Source Type: research

Left Ventricular Assist Devices (LVADS): History, Clinical Application and Complications.
Authors: Eisen HJ Abstract Congestive heart failure is a major cause of morbidity and mortality as well as a major health care cost in the developed world. Despite the introduction of highly effective heart failure medical therapies and simple devices such as cardiac resynchronization therapy that reduce mortality, improve cardiac function and quality of life, there remains a large number of patients who do not respond to these therapies or whose heart failure progresses despite optimal therapy. For these patients, cardiac transplantation is an option but is limited by donor availability as well as co-morbidities w...
Source: Korean Circulation Journal - June 28, 2019 Category: Cardiology Tags: Korean Circ J Source Type: research

Peripheral Component Malfunction of a Fully Magnetically Levitated Centrifugal Pump Masquerading as Pump Thrombosis
We present the case of a HM-3 controller malfunction, resembling pump thrombosis based on acute changes to pump parameters and abnormal LVAD log file analysis.
Source: The Journal of Heart and Lung Transplantation - June 18, 2019 Category: Transplant Surgery Authors: Ioannis Mastoris, Mohamed El Khashab, Travis Abicht Tags: CASE ANECDOTES, COMMENTS AND OPINIONS Source Type: research

Ventricular Assist Device Deactivation in Children: Preparedness Planning and Procedural Checklist
Key difference exist between adult and pediatric Ventricular Assist Device (VAD) care. For many adult patients, VADs are commonly implanted as destination therapy in contrast to pediatric patients who more often receive VAD therapy as a bridge to transplant. Adult patients/families may be better prepared for the anticipated and enivadable complications that occur at the end of destination therapy, but receive benefit from VAD therapy for both prolonged quantity and quality of life. Despite the success of VAD as a bridge to heart transplantation in children, adverse and debilitating events, including stroke, thrombosis, inf...
Source: The Journal of Heart and Lung Transplantation - June 18, 2019 Category: Transplant Surgery Authors: Desiree S. Machado, Seth A. Hollander, Jenna Murray, Joseph Philip, Mark Bleiweis, Sheri Kittelson Tags: Letter to the Editor 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

Using Dental Pulp Stem Cells for Stroke Therapy
Conclusion and Future Perspectives Stem cell-based therapy is a promising alternative for stroke treatment. While stem cells from different sources, including induced PSC, ESC, MSC, and NSC, have been investigated, using NSC and enhancing the natural mechanisms is most appropriate for brain repair. In preclinical models of stroke, stem cell transplantation has led to positive outcomes through a variety of cellular and molecular mechanisms, many being mediated by the array of beneficial factors produced by the cells. Recent advances in cellular reprogramming have provided alternative sources of NSC to be investigated, allo...
Source: Frontiers in Neurology - April 28, 2019 Category: Neurology Source Type: research

Cessation of Anticoagulation for Bleeding and Thrombosis Events with a Fully Magnetically Levitated Centrifugal Left Ventricular Assist Device
Anticoagulation therapy for patients supported by a left ventricular assist device (LVAD) has not been adequately evaluated in relevance to newer pumps, such as the fully magnetically levitated HeartMate 3 pump. Current anticoagulation guidelines target a goal INR of 2.0 –3.0 with vitamin K antagonists to mitigate the risk of pump thrombosis and ischemic stroke, but are based on historical trials with older devices. Long-term outcomes associated with newer devices, such as the centrifugal-flow HeartMate 3 (HM3), have demonstrated a marked decrease in the incidence of pump thrombosis compared to mechanical bearing axial-f...
Source: The Journal of Heart and Lung Transplantation - April 28, 2019 Category: Transplant Surgery Authors: Igor Gosev, Brian Ayers, Katherine Wood, Bryan Barrus, Sunil Prasad Tags: Case Anecdotes, Comments and Opinions Source Type: research

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