scholarly journals HeartMate II Post-marketing Clinical Studies to Further Establish and Expand LVAD Therapy

2015 ◽  
Author(s):  
Faouzi Kallel
Keyword(s):  
Adverse Events ◽  
Survival Rates ◽  
Ventricular Assist Devices ◽  
Circulatory Support ◽  
Actuarial Survival ◽  
Ventricular Assist ◽  
Number Of Patients ◽  
Post Marketing ◽  
Life Improvement ◽  
End Stage

The number of patients with end-stage heart failure (HF) benefiting from mechanical circulatory support based therapy is rapidly growing. Over the last 2 decades the therapy has been rapidly evolving particularly since the introduction of continuous flow ventricular assist devices (CF-LVAD) which addressed several limitations of the first generation pulsatile devices. According to the sixth INTERMACS registry annual report, the 12 and 24 months overall actuarial survival of CF-LVAD was 80% and 70% respectively.1 Survival rates remained unchanged over the past 6 years. The adverse events associated with CF-LVAD have been dramatically reduced when compared to rates associated with the previous generation pulsatile flow devices. The burden of adverse events associated with CF-LVAD decreased over the last 6 years and quality of life improvement at 12 and 24 months remained consistent. According to the report, while the proportion of patients implanted while stable on inotropic support has significantly increased in the last era (2011-2013), the expansion into INTERMACS levels 4 and higher remains limited to 20%.

A Decision Support System for the Treatment of Patients with Ventricular Assist Device Support

2014 ◽  
Vol 53 (02) ◽  
pp. 121-136 ◽  
Author(s):  
E. C. Karvounis ◽  
M. G. Tsipouras ◽  
A. T. Tzallas ◽  
N. S. Katertsidis ◽  
K. Stefanou ◽  
...  
Keyword(s):  
Decision Support ◽  
Decision Support System ◽  
Support System ◽  
Independent Solution ◽  
Exercise Intolerance ◽  
Ventricular Assist Devices ◽  
Circulatory Support ◽  
Ventricular Performance ◽  
Ventricular Assist ◽  
Number Of Patients

SummaryBackground: Heart failure (HF) is affecting millions of people every year and it is characterized by impaired ventricular performance, exercise intolerance and shortened life expectancy. Despite significant advancements in drug therapy, mortality of the disease remains excessively high, as heart transplant remains the gold standard treatment for end-stage HF when no contraindications subsist. Traditionally, implanted Ventricular Assist Devices (VADs) have been employed in order to provide circulatory support to patients who cannot survive the waiting time to transplantation, reducing the workload imposed on the heart. In many cases that process could recover its contractility performance.Objectives: The SensorART platform focuses on the management and remote treatment of patients suffering from HF. It provides an inter-operable, extendable and VAD-independent solution, which incorporates various hardware and software components in a holistic approach, in order to improve the quality of the patients’ treatment and the workflow of the specialists. This paper focuses on the description and analysis of Specialist’s Decision Support System (SDSS), an innovative component of the SensorART platform.Methods: The SDSS is a Web-based tool that assists specialists on designing the therapy plan for their patients before and after VAD implantation, analyzing patients’ data, extracting new knowledge, and making informative decisions.Results: SDSS offers support to medical and VAD experts through the different phases of VAD therapy, incorporating several tools covering all related fields; Statistics, Association Rules, Monitoring, Treatment, Weaning, Speed and Suction Detection.Conclusions: SDSS and its modules have been tested in a number of patients and the results are encouraging.

Innovations in Ventricular Assist Devices for End-Stage Heart Failure

2019 ◽  
Vol 70 (1) ◽  
pp. 33-44 ◽  
Author(s):  
Robert J.H. Miller ◽  
Jeffrey J. Teuteberg ◽  
Sharon A. Hunt
Keyword(s):  
Heart Failure ◽  
Patient Management ◽  
Left Ventricular ◽  
Ventricular Assist Devices ◽  
Left Ventricular Assist Devices ◽  
Ventricular Assist ◽  
Assist Devices ◽  
Number Of Patients ◽  
End Stage Heart Failure ◽  
End Stage

The number of patients with end-stage heart failure (HF) continues to increase over time, but there has been little change in the availability of organs for cardiac transplantation, intensifying the demand for left ventricular assist devices (LVADs) as a bridge to transplantation. There is also a growing number of patients with end-stage HF who are not transplant candidates but may be eligible for long-term support with an LVAD, known as destination therapy. Due to this increasing demand, LVAD technology has evolved, resulting in transformative improvements in outcomes. Additionally, with growing clinical experience patient management continues to be refined, leading to iterative improvements in outcomes. With outcomes continuing to improve, the potential benefit from LVAD therapy is being considered for patients earlier in their course of advanced HF. We review recent changes in technology, patient management, and implant decision making in LVAD therapy.

Differences in Shear Stress, Residence Time and Estimates of Hemolysis Between Different Ventricular Assist Devices

2011 ◽  
Author(s):  
Katharine H. Fraser ◽  
Tao Zhang ◽  
Bartley P. Griffith ◽  
Zhongjun J. Wu
Keyword(s):  
Cardiovascular Disease ◽  
Mechanical Circulatory Support ◽  
Ventricular Assist Devices ◽  
Circulatory Support ◽  
Ventricular Assist ◽  
The Past ◽  
The Us ◽  
Mechanical Circulatory Support Devices ◽  
End Stage ◽  
Support Devices

Cardiovascular disease is the leading cause of mortality globally. Among various forms of cardiovascular disease, heart failure (HF) affects 5.7 million patients in the United States1. Despite optimal treatment, some patients still do not improve and the available therapies fail to control their symptoms; for them, cardiac transplantation may be the only option. However, only around 2200 transplants are performed in the US each year1, or only about 6% of the estimated 35,000 US patients who would benefit actually receive a heart. To address the need to support the circulation in patients with end-stage HF a wide variety of mechanical circulatory support devices (MCSDs) have been developed over the past four decades.

HFrEF other treatment: ventricular assist devices

ESC CardioMed ◽  
2018 ◽  
pp. 1884-1889
Author(s):  
Emer Joyce ◽  
Randall C Starling
Keyword(s):  
Heart Failure ◽  
Adverse Events ◽  
Continuous Flow ◽  
Survival Rates ◽  
Advanced Heart Failure ◽  
Ventricular Assist Devices ◽  
Ventricular Assist ◽  
Assist Devices ◽  
Heart Failure Patients ◽  
Transplant Candidates

Over 30,000 ventricular assist devices (VADs) have been implanted worldwide in the past decade. Continuous-flow VAD therapy has realized greater durability and improved survival. Both axial and centrifugal flow devices are approved for the treatment of chronic and refractory advanced heart failure. Patients waiting for transplants that are ‘bridged’ and transplant-ineligible patients (destination therapy), receive VAD therapy. One-year survival rates are now approximately 80% and 70% at 2 years. The advent of continuous-flow VADs replaced volume displacement pulsatile VADs and numerous adverse events related to lack of circulatory pulsatility became recognized and prevalent as VAD therapy proliferated. Common adverse events include driveline infection, device infection, haemorrhagic and embolic stroke, bleeding, aortic insufficiency, and VAD thrombosis. Current VAD therapy requires systemic anticoagulation and antiplatelet therapy. A lack of donor hearts has resulted in prolonged and frequent VAD therapy in transplant candidates. Careful selection of VAD candidates is imperative and requires careful risk stratification. New VAD models with technological advances will enhance patient acceptance of VAD therapy and lead to further expansion in advanced heart failure patients.

The Pharmacotherapy Implications of Ventricular Assist Device in the Patient With End-Stage Heart Failure

2012 ◽  
Vol 25 (2) ◽  
pp. 232-249 ◽  
Author(s):  
Serena A. S. Von Ruden ◽  
Margaret A. Murray ◽  
Jennifer L. Grice ◽  
Amy K. Proebstle ◽  
Karen J. Kopacek
Keyword(s):  
Heart Failure ◽  
New York ◽  
Heart Association ◽  
Functional Class ◽  
Neurological Dysfunction ◽  
Ventricular Assist Devices ◽  
Circulatory Support ◽  
Ventricular Assist ◽  
End Stage Heart Failure ◽  
End Stage

Advances in mechanical circulatory support, such as the use of ventricular assist devices (VADs), have become a means for prolonging survival in end-stage heart failure (HF). VADs decrease the symptoms of HF and improve quality of life by replacing some of the work of a failing heart. They unload the ventricle to provide improved cardiac output and end-organ perfusion, resulting in improvement in cardiorenal syndromes and New York Heart Association functional class rating. VADs are currently used as a bridge to heart transplantation, a bridge to recovery of cardiac function, or as destination therapy. Complications of VAD include bleeding, infections, arrhythmias, multiple organ failure, right ventricular failure, and neurological dysfunction. Patients with VAD have unique pharmacotherapeutic requirements in terms of anticoagulation, appropriate antibiotic selection, and continuation of HF medications. Pharmacists in acute care and community settings are well prepared to care for the patient with VAD. These patients require thorough counseling and follow-up with regard to prevention and treatment of infections, appropriate levels of anticoagulation, and maintenance of fluid balance. A basic understanding of this unique therapy can assist pharmacists in attending to the needs of patients with VAD.

scholarly journals First-Line Support by Intra-Aortic Balloon Pump in Non-Ischaemic Cardiogenic Shock in the Era of Modern Ventricular Assist Devices

Cardiology ◽  
2017 ◽  
Vol 138 (1) ◽  
pp. 1-8 ◽  
Author(s):  
Corstiaan A. den Uil ◽  
Giorgia Galli ◽  
Lucia S. Jewbali ◽  
Kadir Caliskan ◽  
Olivier C. Manintveld ◽  
...  
Keyword(s):  
Cardiogenic Shock ◽  
Left Ventricular ◽  
Ventricular Assist Devices ◽  
Circulatory Support ◽  
First Line ◽  
Ventricular Assist ◽  
Intra Aortic Balloon Pump ◽  
Coronary Syndrome ◽  
Iabp Support ◽  
End Stage

Objectives: Little is known about circulatory support in cardiogenic shock (CS) from other causes than the acute coronary syndrome or after cardiotomy. We evaluated the effects of first-line intra-aortic balloon pump (IABP) support in this subpopulation of CS patients. Methods: A retrospective study was performed in 27 patients with CS from end-stage cardiomyopathy supported firstly by IABP in the years 2011-2016. Results: At 24 h, lactate decreased from 3.2 (2.1-6.8) to 1.8 (1.2-2.2) mmol/L (p < 0.001). Eighteen patients (67%) defined as IABP responders were successfully bridged to either recovery (n = 7), left ventricular assist device (n = 5), or heart transplantation (n = 6). IABP failed in 9 patients (non-responders, 33%) who either died (n = 7) or needed support by extracorporeal membrane oxygenation (n = 2). At 24 h of IABP support, urinary output was higher (2,660 [1,835-4,440] vs. 1,200 [649-2,385] mL; p = 0.02) and fluid balance more negative (-1,564 [-2,673 to -1,086] vs. -500 [-930 to +240] mL; p < 0.001) in responders than non-responders. Overall survival at 1 year was 63%. Conclusion: In most patients, first-line support by IABP in end-stage cardiomyopathy is associated with improvement in organ perfusion and clinical stabilisation for at least 24 h allowing time for decision making on next therapies.

scholarly journals Left Ventricular Assist Devices in the Management of Heart Failure

2015 ◽  
Vol 1 (1) ◽  
pp. 25 ◽  
Author(s):  
Edo Y Birati ◽  
Mariell Jessup ◽  
◽  
Keyword(s):  
Heart Failure ◽  
Left Ventricular ◽  
Ventricular Assist Devices ◽  
Circulatory Support ◽  
Left Ventricular Assist Devices ◽  
Ventricular Assist ◽  
Reduced Ejection Fraction ◽  
Device Implantation ◽  
Clinical Presentations ◽  
End Stage

Mechanical circulatory support has emerged as an important therapy for advanced heart failure, with more than 18,000 continuous flow devices implanted worldwide to date. These devices significantly improve survival and quality of life and should be considered in every patient with end-stage heart failure with reduced ejection fraction who has no other life-limiting diseases. All candidates for device implantation should undergo a thorough evaluation in order to identify those who could benefit from device implantation. Long-term management of ventricular assist device patients is challenging and requires knowledge of the characteristic complications with their unique clinical presentations.

scholarly journals Eradication of Ventricular Assist Device Driveline Infection in Paediatric Patients with Taurolidine

2022 ◽  
Vol 9 (1) ◽  
pp. 18
Author(s):  
Johannes Weichsel ◽  
Benito Baldauf ◽  
Hendrik Bonnemeier ◽  
Ernest W. Lau ◽  
Sven Dittrich ◽  
...  
Keyword(s):  
Skin Barrier ◽  
Ventricular Assist Devices ◽  
Circulatory Support ◽  
The Novel ◽  
Ventricular Assist ◽  
Cardiac Implantable Electronic Devices ◽  
External Power Source ◽  
Driveline Infection ◽  
External Power ◽  
End Stage

Ventricular assist devices (VADs) are used to provide mechanical circulatory support to patients with end-stage heart failure. The driveline connecting the external power source to the pump(s) of the intra-corporal VAD breaches the protective skin barrier and provides a track for microbes to invade the interior of the patient’s body. Driveline infection constitutes a major and potentially fatal vulnerability of VAD therapy. Driveline infection cannot traditionally be salvaged and requires the extraction of the entire VAD system. We report here the successful eradication of a VAD driveline infection with a taurolidine-containing antimicrobial solution used for preventing the infection of cardiac implantable electronic devices. If replicated in more cases, the novel treatment concept described here may provide a valuable alternative management strategy of salvage rather than explantation for VAD driveline infection.

scholarly journals COULD THE FULLY IMPLANTABLE LIONHEARTTM BE A FUTURE SOLUTION CONSIDERING THE LIMITED NUMBER OF DONORS FOR CARDIAC TRANSPLANT?

1970 ◽  
pp. 135-148
Author(s):  
Mario Viganò ◽  
Andrea Maria D'Armini ◽  
Carlo Pellegrini ◽  
Alessia Alloni
Keyword(s):  
Heart Transplantation ◽  
Therapeutic Option ◽  
Ventricular Assist Devices ◽  
Circulatory Support ◽  
Cardiac Transplant ◽  
Proper Solution ◽  
Ventricular Assist ◽  
Assist Devices ◽  
Number Of Patients ◽  
Ventricular Assistance

Cardiac failure constitutes one of the main health problems in western countries. Despite the recent outstanding progress the pharmaceutical treatment of this condition is not suitable to overcome a great percentage of failures and an insufficient quality of life for many patients. The heart transplantation today is considered the most suitable therapeutic option. However, the limited number of donors compared to the great number of patients on the waiting list constitute a major limitation of this solution. The initial experience on the development of cardiac assist devices conceived as a “bridge to the transplantation” based on mechanical circulatory support has provided encouraging results to use such devices (ventricular assist devices) for a long period which could be considered as an acceptable therapeutic solution. The recent technological developments have made available the necessary miniaturization of the various mechanical components of the system for ventricular assistance and the proper solution for energy supply and control. On the light of the positive results obtained the ventricular assist devices can be considered today a permanent solution for a significant number of patients. This chapter illustrates the first Italian experience on the clinical application of the LionHeart, a totally implantable system for ventricular assistance. A concise description of the system and the surgical technique for implantation are provided and the preliminary results on the short term are discussed. Even considering the limited period of observation, this therapeutic option appears to be safe and suitable for a selected population of patients which cannot be considered proper candidates for heart transplantation.

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