Tag Archives: LVAD

New HeartMate 3 LAVD Reduces Risk of Strokes and Clots

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MedicalResearch.com Interview with:

Mandeep R. Mehra, MD, MSc, FRCP (London)The William Harvey Distinguished Chair in Advanced Cardiovascular MedicineMedical Director, Heart and Vascular Center, Brigham and Women’s HospitalExecutive Director, Center for Advanced Heart DiseaseBrigham and Women’s HospitalProfessor of Medicine, Harvard Medical School

Dr. Mehra

Mandeep R. Mehra, MD, MSc, FRCP (London)
The William Harvey Distinguished Chair in Advanced Cardiovascular Medicine
Medical Director, Heart and Vascular Center
Brigham and Women’s Hospital
Executive Director
Center for Advanced Heart Disease
Brigham and Women’s Hospital
Professor of Medicine, Harvard Medical School 

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: The MOMENTUM 3 trial is the largest study of LVAD therapy in Advanced Heart Failure with over 1000 randomized patients followed to at least 2 years. This trial tested a novel fully magnetically levitated LVAD, the HeartMate 3 pump against a mechanical bearing containing LVAD, the HeartMate II pump in patients suffering from advanced heart failure (85% of whom were on continuous intravenous Inotropic therapy or IABP device at the time of randomization). While LVADs have improved survival for such patients, the morbidity has remained excessive due to serious complication as a result of problems with hemocompatibility.

The principal concerns revolve around complications of pump thrombosis requiring surgical replacement, strokes and bleeding events, especially gastrointestinal bleeding. The trial has previously reported two interim analyses which suggested signals for superiority on pump replacement and even a decrease in ischemic stroke.

This final full report concludes convincingly that all three domains of hemocompatibility related adverse events are reduced with the novel LVAD with near elimination of pump thrombosis, halving of strokes of any kind and any severity and a marked decrease in bleeding complications.

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Readmissions After LVAD For Heart Failure High, Mostly For Non-Cardiac Causes

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MedicalResearch.com Interview with:
Dr. Sahil Agrawal, MBBS MD
Division of Cardiology, St. Luke’s University Health Network, Bethlehem, PA
Dr Lohit Garg MD
Division of Cardiology
Lehigh Valley Health Network, Allentown 

MedicalResearch.com: What is the background for this study?

Response: Readmissions among advanced heart failure patients are common and contribute significantly to heath care related costs. Rates and causes of readmissions, and their associated costs among patients after durable left ventricular assist device (LVAD) implantation have not been studied in a contemporary multi-institutional setting. We studied the incidence, predictors, causes, and costs of 30-day readmissions after LVAD implantation using Nationwide Readmissions Database (NRD) in our recently published study.

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Decision Aids Can Help Heart Failure Patients Determine If They Want an LVAD

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MedicalResearch.com Interview with:

A left ventricular assist device (LVAD) pumping blood from the left ventricle to the aorta, connected to an externally worn control unit and battery pack. Wikipedia image

A left ventricular assist device (LVAD) pumping blood from the left ventricle to the aorta, connected to an externally worn control unit and battery pack.
Wikipedia image

Larry A. Allen, MD, MHS
Associate Professor, Medicine
Associate Head for Clinical Affairs, Cardiology
Medical Director, Advanced Heart Failure
Aurora, CO 80045

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: Deciding whether or not to get a left ventricular assist device (LVAD) is one of the most challenging medical decisions created by modern medicine.

LVADs improve overall survival but also come with serious risks and lifestyle changes. Particularly for older patients with multiple medical problems, this is a complex choice.

Our research group at the University of Colorado spent years systematically developing unbiased pamphlet and video decision aids for patients and caregivers. We also developed a clinician-directed decision support training for LVAD program staff. The DECIDE-LVAD trial studied the implementation and effectiveness of this decision support intervention with patients and their caregivers in 6 hospitals in the U.S. When compared to previously used education materials, the decision aids appeared to improve patients’ decision quality and lowered the total number of patients getting LVADs.

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Advanced Heart Failure Patients Should Have Option of LVAD Device

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MedicalResearch.com Interview with:
Amrut V. Ambardekar, MD
Medical Director Cardiac Transplant Program
Division of Cardiology, Section of Advanced Heart Failure-Transplant Cardiology
University of Colorado

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: As left ventricular assist device (LVAD) technology has improved, the appropriate timing for implant of these devices (essential a form of an artificial heart pump) in patients with advanced heart failure is unknown.

The goal of the MedaMACS study was to describe the prognosis of a group of patients with advanced heart failure who currently do not require intravenous therapies, and determine how they compare to a similar group of patients who received a LVAD.

The main finding from this study is that the “sickest” group of patients with advanced heart failure on oral medical therapy (known as INTERMACS profile 4 patients) have very poor outcomes with a strong trend for improvement in survival with LVAD therapy.

The other take home message is that among all of the patients enrolled in the study on medical therapy, only approximately half were alive after an average of 12 months of follow up without needing a heart transplant or LVAD placement.

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LVADs Improve Survival and Quality of Life In Some Heart Failure Patients

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Jerry D. Estep, MD, FACC, FASE Associate Professor of Clinical Cardiology Houston Methodist Institute of Academic Medicine Section Head of Heart Transplant & Mechanical Circulatory Support, Division of Heart Failure Medical Director, Heart Transplant & LVAD Program Methodist DeBakey Heart & Vascular Center Houston MethodistMedicalResearch.com Interview with:
Jerry D. Estep, MD, FACC, FASE
Associate Professor of Clinical Cardiology
Houston Methodist Institute of Academic Medicine
Section Head of Heart Transplant & Mechanical Circulatory Support, Division of Heart Failure
Medical Director, Heart Transplant & LVAD Program
Methodist DeBakey Heart & Vascular Center
Houston Methodist

 

Medical Research: What is the background for this study? What are the main findings?

Dr. Estep: Data for left ventricular assist devices (LVADs) in non-inotrope-dependent advanced heart failure (HF) patients are limited. The risk-benefit tradeoff of LVADs versus optimal medical management (OMM) in this patient cohort is not well understood.  ROADMAP is the first prospective, nonrandomized, observational study comparing LVAD support to OMM in advanced, ambulatory HF patients who are not dependent on intravenous inotropic support, and meet the FDA-approved indications for LVAD destination therapy.  The main  5 findings from the ROADMAP Study include the following:

1) LVAD patients were more severely ill, with more INTERMACS profile 4 compared to OMM patients (65% LVAD vs. 34% OMM, p < 0.001);

2) more LVAD patients met the primary endpoint of survival on original therapy with improvement in 6 minute walk distance of at least 75 meters at 12 months (39% LVAD vs. 21% OMM; [OR: 2.4 [95% CI: 1.2 to 4.8]; p = 0.012) with differences in the primary endpoint primarily due to the use of delayed LVADs in the OMM group;

3) on the basis of as-treated (event free) analysis, 12-month survival (freedom from death, urgent transplant, or delayed LVAD) was greater for LVAD versus OMM (80 ± 4% vs. 63 ± 5%, p = 0.022);

4) adverse events (AEs) were higher in LVAD patients, at 1.89 events/patient-year (eppy), primarily driven by bleeding (1.22 eppy), than with OMM, at 0.83 eppy, primarily driven by worsening HF (0.68 eppy);  and

5) health-related quality of life and depression improved from baseline more significantly with LVADs than with OMM (Δvisual analog score [VAS]: 29 ± 25 vs. 10 ± 22, p < 0.001 and ΔPHQ9: -5 ± 7 vs. -1 ± 5, p < 0.001).

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Social Media Seen As Important Resource For LVAD Patients and Caregivers

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Dr. Kristin Kostick PhD on behalf of the authors Research Associate - Decision Making and Ethics Research Program Center for Medical Ethics and Health Policy Baylor College of Medicine Houston, TXMedicalResearch.com Interview with:
Dr. Kristin Kostick PhD on behalf of the authors
Research Associate – Decision Making and Ethics Research Program
Center for Medical Ethics and Health Policy
Baylor College of Medicine
Houston, TX

Medical Research: What is the background for this study? What are the main findings?

Response: The idea of this study came from a larger research study we’re doing to develop and test a decision aid for patients and caregivers considering LVAD treatment. As part of that study, we interviewed LVAD patients, candidates, caregivers and decliners of LVAD treatment to explore their decisional needs. One of the things that kept coming up in these interviews was the need for “support,” which everyone, including clinicians, identified as a crucial aspect of post-implant recovery. There is an excellent clinical support team at our partnering hospital in Houston, as well as a community of LVAD recipients and caregivers where people can get together to share their stories and resources face-to-face. But for other people who find it difficult to get to the hospital, either because they have transportation barriers or they simply live too far away, we began to wonder whether support services might be available to them in virtual settings. So we decided to do this analysis to see what social media sites exist for the LVAD community. What is the content of these sites? Are there different kinds for different support needs? What are patients getting from them? How might they be used in the future for improving patient care and support?

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Depression, Illicit Drug Use Linked To Readmissions After LVAD Placement

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Shannon M. Dunlay, M.D. M.S. Advanced Heart Failure and Cardiac Transplantation Assistant Professor of Medicine and Health Care Policy and Research Mayo Clinic RochesterMedicalResearch.com Interview with:
Shannon M. Dunlay, M.D. M.S.
Advanced Heart Failure and Cardiac Transplantation
Assistant Professor of Medicine and Health Care Policy and Research
Mayo Clinic Rochester

MedicalResearch: What is the background for this study? What are the main findings?

Dr. Dunlay: Left ventricular assist devices (LVAD) are increasingly utilized as destination therapy (DT) in patients that are not candidates for heart transplantation. Optimal patient selection is essential in improving outcomes, but many of the factors associated with favorable outcomes remain poorly understood. It is important for us to better understand the role that psychosocial factors may play in outcomes after DT LVAD. Unlike transplant, where the limited organ supply requires choosing candidates with optimal psychosocial characteristics, DT LVAD therapy is more readily available as it does not rely on organ donors. There are no clear guidelines on what constitutes an acceptable psychosocial risk prior to DT LVAD. As a result, many programs will offer DT LVAD to candidates despite psychosocial concerns if it is felt they will otherwise benefit. Data are needed to inform programs about whether such candidates are truly at elevated risk of adverse outcomes.

In our single-center study including 131 patients, we found that several psychosocial characteristics are predictive of readmission after DT LVAD. A history of illegal drug use and depression are associated with a higher risk of readmission, while tobacco use is associated with lower readmission risk. Psychosocial characteristics were not significant predictors of death after DT LVAD.

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Destination LVAD Devices Come With Caregivers’ Concerns and Tensions

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Colleen K. McIlvennan, DNP, ANP Assistant Professor of Medicine University of Colorado, Division of Cardiology Section of Advanced Heart Failure and TransplantationMedicalResearch.com Interview with:
Colleen K. McIlvennan, DNP, ANP
Assistant Professor of Medicine
University of Colorado, Division of Cardiology
Section of Advanced Heart Failure and Transplantation

Medical Research: What is the background for this study?

Response: Destination therapy left ventricular assist device (DT LVAD) patients are often older with significant comorbidities that preclude heart transplantation. As such, the decision to get a DT LVAD is arguably more complicated than the decision to receive a temporary LVAD in anticipation of a transplant. Centers offering LVADs often require the identification of a caregiver prior to proceeding with the implant. Caregivers are commonly female spouses of DT LVAD patients, who are also older with co-morbidities. Understanding their perspective in DT LVAD decision making is extremely important as they are at particular risk for experiencing stress and caregiver burden due to the increased demands on caregiving with DT LVAD.

Medical Research: What are the main findings?

Response: We performed semi-structured qualitative interviews with 17 caregivers: 10 caregivers of patients living with DT LVAD, 6 caregivers of patients who had died with DT LVAD, and 1 caregiver of a patient who had declined DT LVAD. Throughout the interviews, the overarching theme was that considering a DT LVAD is a complex decision-making process.

Additionally, three dialectical tensions emerged:
1) the stark decision context, with tension between hope and reality;
2) the challenging decision process, with tension between wanting loved ones to live and wanting to respect loved ones’ wishes; and
3) the downstream decision outcome, with tension between gratitude and burden.

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Echo Useful In Measuring Cardiac Hemodyanamics In LVAD Patients

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Jerry D. Estep, M.D., FACC Assistant Professor of Medicine, Weill Cornell Medical College Medical Director, Heart Transplant & LVAD Program Methodist DeBakey Heart & Vascular Center Houston Methodist HospitalMedicalResearch.com Interview with:
Jerry D. Estep, M.D., FACC
Assistant Professor of Medicine, Weill Cornell Medical College
Medical Director, Heart Transplant & LVAD Program
Methodist DeBakey Heart & Vascular Center
Houston Methodist Hospital

Medical Research: What are the main findings of the study?

Dr. Estep: There were two major findings:

1-Non-invasive Doppler echocardiographic and invasive measures of mean right atrial pressure (RAP) (r = 0.863; p < 0.0001), systolic pulmonary artery pressure (sPAP) (r=0.880; p<0.0001), right ventricular outflow tract stroke volume (r=0.660; p < 0.0001), and pulmonary vascular resistance (r = 0.643; p= 0.001) correlated significantly.

2-An algorithm integrating mitral inflow velocities, RAP, sPAP, and left atrial volume index was 90% accurate in distinguishing normal from elevated left ventricular filling pressures.
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How Do Patients Decide to Accept a LVAD – Left Ventricular Assist Device?

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MedicalResearch.com Interview with: Colleen K. McIlvennan, DNP, ANP Assistant Professor of Medicine University of Colorado, Division of Cardiology Section of Advanced Heart Failure and TransplantationMedicalResearch.com Interview with:
Colleen K. McIlvennan, DNP, ANP
Assistant Professor of Medicine
University of Colorado, Division of Cardiology
Section of Advanced Heart Failure and Transplantation

 

MedicalResearch: What are the main findings of the study?

Answer: We interviewed 22 patients who were offered destination therapy left ventricular assist devices (DT LVAD), 15 with DT LVADs and 7 who declined. We found a strong dichotomy between decision processes with some patients (11 accepters) being automatic and others (3 accepters, 7 decliners) being reflective in their approach to decision making. The automatic group was characterized by a fear of dying and an overriding desire to live as long as possible: [LVAD] was the only option I had…that or push up daisies…so I automatically took this. In contrast, the reflective group went through a reasoned process of weighing risks, benefits, and burdens: There are worse things than death. Irrespective of approach, most patients experienced the DT LVAD decision as a highly emotional process and many sought support from their families or spiritually.

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