Breaking News
April 20, 2019 - Texas A&M AgriLife becomes the newest member of NutriRECS international consortium
April 20, 2019 - In most states, insurance won’t cover addiction treatments
April 20, 2019 - Computer-based memory games may be beneficial for individuals with fragile X syndrome
April 20, 2019 - Timing of food intake influences molecular clock in the liver of mice
April 20, 2019 - Precise decoding of breast cancer cells paves way for new treatment option
April 20, 2019 - Scientists use 3D imaging to help model complex processes performed by placenta
April 20, 2019 - MediciNova Announces Plans to Move Forward with a Phase 3 Trial of MN-166 (ibudilast) in ALS
April 20, 2019 - Genetic variants that protect against obesity could aid new weight loss medicines
April 20, 2019 - New technology developed for microscopic imaging in living organisms
April 20, 2019 - when quitting cigarettes, consider using more nicotine, not less
April 20, 2019 - Key proteins can block Listeria without triggering the death of host cells
April 20, 2019 - Researchers create a working model of cerebral tract to study brain function
April 20, 2019 - New study shows that microbes can help break toxic chemical in dust
April 20, 2019 - Scientists use NIR light and injected DNA nanodevice to guide stem cells to injury
April 20, 2019 - Microbial Features ID’d for Pediatric Irritable Bowel Syndrome
April 20, 2019 - Study reveals patterns of drug intoxication deaths, organ donors across the US
April 20, 2019 - Scientists deploy CRISPR gene-editing tool to engineer multiple edits
April 20, 2019 - AHA News: Here’s How Middle-Aged People — Especially Women — Can Avoid a Heart Attack
April 20, 2019 - Charcot foot: MedlinePlus Medical Encyclopedia
April 20, 2019 - France to ban popular breast implants over cancer risk: media
April 20, 2019 - Researchers explore whether time of day can affect the body’s response to physical exertion
April 20, 2019 - CPAP brings longer life for obese people with sleep apnea: Study
April 20, 2019 - New discovery transforms conventional microfluidics into open-space microfluidics
April 20, 2019 - An accurate estimation of the overall cost of bacterial resistance in French hospitals during 2015 and 2016
April 20, 2019 - ‘PRO-cision Medicine’ approach helps personalize care for patients with cancer
April 19, 2019 - TG Therapeutics Receives Orphan Drug Designation for Umbralisib from the U.S. Food and Drug Administration for the Treatment of Marginal Zone Lymphoma
April 19, 2019 - Screen time—even before bed—has little impact on teen well-being: study
April 19, 2019 - Cytosurge’s first FluidFM User Conference
April 19, 2019 - New study finds that previously described differences among endoscopists are not true
April 19, 2019 - Study compares effectiveness and cost of gene therapy and HSCT in major beta-thalassemia
April 19, 2019 - Scientific breakthrough provides new hope for people living with multiple sclerosis
April 19, 2019 - New Virtual Reality Therapy game could offer relief for patients with chronic pain, mobility issues
April 19, 2019 - Emergency medicine doctors find better way to treat severe epileptic seizures in children
April 19, 2019 - MedlinePlus: Cholesterol Good and Bad
April 19, 2019 - For busy medical students, two-hour meditation study may be as beneficial as longer course
April 19, 2019 - Music therapy helps young patients feel better
April 19, 2019 - Molecular target UNC45A is essential for cancer cell proliferation and tumor growth
April 19, 2019 - Crackling and wheezing could be the sounds of a progressing lung disease
April 19, 2019 - Key research takeaways from ECCMID 2019
April 19, 2019 - AI Can Identify Model of Cardiac Rhythm Device From Chest X-Ray
April 19, 2019 - New way to combat childhood anxiety: treat the parents
April 19, 2019 - Women getting C-sections best judge of own pain medication needs | News Center
April 19, 2019 - Light-intensity physical activity associated with healthy brain aging
April 19, 2019 - Immune responses that prevent fungal infections may eliminate Trichinella spiralis
April 19, 2019 - Exercising in the morning, rather than at night, may yield better results, shows study
April 19, 2019 - Why eating ‘right’ could cause you to stray from your diet
April 19, 2019 - Health Tip: Antidepressant Precautions – Drugs.com MedNews
April 19, 2019 - Bigger portions lead to preschoolers eating more over time
April 19, 2019 - Specific strains of Staphylococcus aureus linked to wounds that do not heal
April 19, 2019 - Morning exercise may burn more calories
April 19, 2019 - Revolutionary discovery paves new way for treatment of necrotizing enterocolitis
April 19, 2019 - Drug that treats high blood pressure shows promise against neurodegenerative diseases
April 19, 2019 - More care is needed for patients after kidney transplantations, reports research
April 19, 2019 - Virtual reality offers benefits for Parkinson’s disease patients
April 19, 2019 - Liver Illness Strikes Latino Children Like A ‘Silent Tsunami’
April 19, 2019 - Disruptive behaviors in autistic children linked to reduced brain connectivity
April 19, 2019 - New insights into how vitamin D affects immune system
April 19, 2019 - Research sheds light on how hepatitis B virus establishes chronic infection
April 19, 2019 - New scoring system based on genetic markers predicts obesity risk at birth
April 19, 2019 - Pfizer Announces Presentation of Data from a Phase 2 Study of its 20-Valent Pneumococcal Conjugate Vaccine Candidate Being Investigated for the Prevention of Invasive Disease and Pneumonia in Adults Aged 18 Years and Older
April 19, 2019 - Exercise can improve non-motor symptoms of Parkinson’s disease
April 19, 2019 - Phasefocus to launch new cell imaging system
April 19, 2019 - KZFPs play a key role in the regulation of human genome
April 19, 2019 - DWK Life Sciences offers Workflow Solutions to improve productivity
April 19, 2019 - Bedfont wins 2nd accolade at the South East FSB Awards 2019
April 19, 2019 - Extracts of ginkgo seeds show antibacterial activity on pathogens that cause skin infections
April 19, 2019 - Groundbreaking experiment in pigs challenges the notion about brain damage
April 19, 2019 - Improving the quality of digital pathology imaging
April 19, 2019 - Scientists get closer to injecting artificial lymph nodes into people to fight disease
April 19, 2019 - Exercises and swimming goggles may reduce adverse effects on eye during long spaceflights
April 19, 2019 - Review suggests a reciprocal relationship between obesity and self-control
April 19, 2019 - Synthetic biologists add analog-to-digital signal processing to genetic circuitry of living cells
April 19, 2019 - Study identifies how enterococci bacteria cause antibiotic-resistant bloodstream infections
April 19, 2019 - Triple negative breast cancer develop resistance to chemotherapy by turning on molecular pathway
April 19, 2019 - Researchers identify key clues to brain and pancreas development
April 19, 2019 - Metformin May Cut Risk for Prematurity, Miscarriage in PCOS
April 19, 2019 - Obese mouse mothers trigger heart problems in offspring
April 19, 2019 - Research sheds light on how leukemia cells become resistant to drugs
April 19, 2019 - Health Tip: Stopping Nosebleeds – Drugs.com MedNews
April 19, 2019 - Pediatric endocrinologist gives iconic ‘Mona Lisa’ a second medical opinion
Next-generation LVAD device clinically superior, safer for heart failure patients

Next-generation LVAD device clinically superior, safer for heart failure patients

image_pdfDownload PDFimage_print

The final results are in for MOMENTUM 3, the largest left-ventricular assist device (LVAD) trial ever conducted. The study of more than 1,000 patients with severe heart failure not only confirms that the HeartMate 3, a next-generation LVAD device, markedly reduced the need for re-operations due to pump malfunctions, but also found that it lowered risk of bleeding events and strokes, compared to the HeartMate II. Results were presented in a Late Breaking Clinical Trial at the American College of Cardiology’s 68th Annual Scientific Session by Mandeep R. Mehra, MD, executive director of the Center for Advanced Heart Disease and medical director of the Heart & Vascular Center at Brigham and Women’s Hospital, and published simultaneously online in the New England Journal of Medicine.

“We are thrilled to have completed the largest LVAD trial in the world, to see that all of the early benefits we observed in interim analyses were sustained, and to report reductions in pump-related thrombosis, strokes and mucosal bleeding — three measures of hemocompatibility — compared to the previous generation of cardiac pump,” said Mehra. “Our results should spur confidence that we now have a much more forgiving pump and should provide reassurance to clinicians that we do not need to wait until a patient is ‘near death’ to consider this option for our patients.”

MOMENTUM 3, sponsored by Abbott Inc., compared Abbott’s HeartMate 3 left ventricular assist system, a magnetically-levitated, continuous centrifugal-flow circulatory pump, to the HeartMate II, a commercial axial flow pump. The trial evaluated how many participants, two years after receiving their device, had not suffered a disabling stroke or had an operation to replace or remove a malfunctioning device.

A total of 1,028 patients were randomized to receive either the centrifugal flow pump or the axial flow pump. The team found that 397 patients (76.9 percent) in the centrifugal-flow pump group did not experience a disabling stroke or need a re-operation compared to 332 (64.8 percent) in the axial-flow pump group. Only 12 people who received the centrifugal-flow pump needed a re-operation compared to 57 patients who received the axial pump. The centrifugal-flow pump reduced risk of stroke by 58 percent, major bleeding by 36 percent and gastrointestinal hemorrhage by 36 percent. Infection rates and rates of right heart failure were no different between the two groups.

MOMENTUM 3 launched in 2014 and was designed to dramatically reduce the overall timeline for clinical trials. All patients with refractory heart failure who needed a cardiac pump were eligible for the trial, regardless of whether the pump was intended as a bridge to transplantation or destination therapy. Based on the study’s first interim analysis at six months, the HeartMate 3 was approved in 2017 by the FDA for use as a short-term device, such as for a bridge to transplantation. Last fall, supported by the second interim results of MOMENTUM 3, the pump was approved by the FDA as a long-term use device, such as for patients with advanced heart failure who are not eligible for a heart transplant.

The HeartMate 3 includes several technological adaptations intended to reduce risk of complications. The fully magnetically levitated device runs like a bullet train — its rotor has no mechanical bearings in it and pushes the blood using only magnetism. It is designed to reduce shear stress and destruction of blood elements as they pass through the pump, which is thought to cause blood clots to form in pumps.

Reductions in bleeding events, re-operations and strokes could translate to important cost savings. The team calculated that in every 10 patients implanted with the centrifugal-flow pump, compared with the axial-flow pump, 2.2 pump thrombosis events, two strokes and 6.8 bleeding events would be averted over a two-year period.

“Until now, these devices have been considered less cost-effective, which has been a big issue outside of the U.S.,” said Mehra. “Our evidence shows a decreased need for hospitalization and re-operations, indicating that the centrifugal-flow pump may be much more cost-friendly in the longer term.”

Mehra notes that residual risks remain, including infections, which occur in nearly 50 percent of patients. Many, but not all, of these infections occur at the entry point of the drive line that powers the device. In addition, low-frequency, right-ventricular heart failure events can occur. Mehra is now chairing a follow-up trial that will specifically examine these challenges and what modifications can be made to address them.

MOMENTUM 3 is sponsored by Abbott, Inc., and the complete protocol, designed by the sponsor in consultation with clinical advisors and the study oversight committee, is available at NEJM.org. Mehra reports receiving travel support and consulting fees, paid to Brigham and Women’s Hospital, from Abbott. He is also a consultant to Medtronic, Janssen, Mesoblast, NupulseCV, Fine Heart, Bayer and Portola. Co-authors also report receiving consulting fees, teaching fees, lecture fees, travel support and research grants from Abbott and Medtronic.

Source:

https://www.brighamandwomens.org/

Tagged with:

About author

Related Articles