Breaking News
April 23, 2019 - Sensory Sensitivity Tied to Constipation in Young Children
April 23, 2019 - More than half of internal medicine graduates choosing primary care
April 22, 2019 - Researchers discover good news for fish populations living on bleached coral reefs
April 22, 2019 - Plant-based diets associated with lower risk of heart failure
April 22, 2019 - Food Allergies Can Strike at Any Age
April 22, 2019 - Cerebro-facio-thoracic dysplasia – Genetics Home Reference
April 22, 2019 - Poverty leaves a mark on our genes
April 22, 2019 - Countdown to Big Data in Precision Health: When industry and academia converge
April 22, 2019 - The U.S government may account for up to $37.8 billion due to opioid epidemic
April 22, 2019 - Improving ACA’s Insurance Coverage Provisions will lead to better care for patients
April 22, 2019 - Study identifies possible therapeutic effects of curcumin on stomach cancer
April 22, 2019 - Hyaline fibromatosis syndrome – Genetics Home Reference
April 22, 2019 - Scientists use CRISPR for possible ‘bubble boy’ therapy
April 22, 2019 - Hematologist (and a mom, singer, actress and much more) stands up for diversity
April 22, 2019 - Novel AI voice tool can help diagnose PTSD
April 22, 2019 - Overlooked part of cell’s internal machinery may hold key to treating acute myeloid leukemia
April 22, 2019 - Soft bedding responsible for majority of sleep-related infant deaths, study reveals
April 22, 2019 - Study finds worse health-related quality of life among transgender adults
April 22, 2019 - MIT scientists reverse some behavioral symptoms of rare neurodevelopmental disorder
April 22, 2019 - Scientists find new therapy target for drug-induced liver failure
April 22, 2019 - Opioid dose variability could lead to increased risk of overdose, study suggests
April 22, 2019 - Newly developed model predicts salmonella outbreaks several months in advance
April 22, 2019 - Deep-learning model better predicts survival outcomes for lung cancer
April 22, 2019 - One in Three U.S. Adults Aged 35 to 44 May Have Drinking Problem
April 22, 2019 - Why the measles virus is so contagious
April 22, 2019 - Magnet ‘Zap’ to the Brain Might Jumpstart Aging Memory
April 22, 2019 - Immune response to gut microbes may be early indicator of type 1 diabetes
April 22, 2019 - Destination Limbo: Health Suffers Among Asylum Seekers In Crowded Border Shelter
April 22, 2019 - Research shows how dopamine contributes to sex differences in worms
April 22, 2019 - Marijuana users weigh less compared to non-users
April 22, 2019 - Research uncovers critical RNA processing aberrations in ALS and FTD
April 22, 2019 - Many cancer patients use marijuana and prescription opioids, study reveals
April 22, 2019 - Frailty may up fracture risk in patients with type 2 diabetes
April 22, 2019 - Study provides new insight into how obesity, insulin resistance can affect cognition
April 22, 2019 - Study seeks to better understand the genetic causes for hypospadias
April 22, 2019 - FDA grants approval of first generic naloxone nasal spray to treat opioid overdose
April 22, 2019 - FDA authorizes marketing of first medical device to treat ADHD
April 22, 2019 - Vanderbilt researchers to develop and test ‘safe harbor’ standards of care
April 22, 2019 - You’re probably brushing your teeth wrong – here are four tips for better dental health
April 22, 2019 - Pharmacy closures contribute to medication non-adherence among heart patients
April 22, 2019 - Using Edge AI technology to observe behavior of cattle
April 22, 2019 - Bacteria play a role in the development of stomach ulcers in pigs
April 22, 2019 - Hand Hygiene Compliance Poor in Task Transitions
April 22, 2019 - smoking could harm your baby
April 22, 2019 - Scientists identify rare, paradoxical response to antiretroviral therapy
April 21, 2019 - More TV, Tablets, More Attention Issues at Age 5
April 21, 2019 - Drug reduces risk of kidney failure in people with diabetes, study finds
April 21, 2019 - New research identifies novel link between antibiotic resistance and climate change
April 21, 2019 - Simple intervention can provide lasting protection for teens against junk food marketing
April 21, 2019 - The protein p38-gamma identified as a new therapeutic target in liver cancer
April 21, 2019 - Novel system enables researchers to study bacteria within mini-tissues in a dish
April 21, 2019 - Discovery of oral cancer biomarkers could save thousands of lives
April 21, 2019 - Geneva Exhibition committee gives gold medals to two medications developed by Kazan
April 21, 2019 - Scientists aim to minimize or eliminate hair loss during cancer treatment
April 21, 2019 - WiFi interacts with signaling pathways in the human brain
April 21, 2019 - Stroke Hospitalizations Down in Black, White Medicare Enrollees
April 21, 2019 - First common risk genes discovered for autism
April 21, 2019 - Researchers map auditory sensory system of the mouse brain
April 21, 2019 - Scientists Bring Pig’s Brain, Dead 4 Hours, Back to ‘Cellular Activity’
April 21, 2019 - Virtual reality a promising tool for reducing fears and phobia in autism
April 21, 2019 - New analysis lists out opportunities for U.S. medical schools to advance population health
April 21, 2019 - More sleep may help teens with ADHD focus and organize
April 21, 2019 - Breakthrough antibody treatment suppresses HIV without antivirals
April 21, 2019 - AveXis Data Reinforce Effectiveness of Zolgensma in Treating Spinal Muscular Atrophy (SMA) Type 1
April 21, 2019 - Is your hand pain arthritis, carpal tunnel or something else?
April 21, 2019 - Measles outbreaks may become more frequent if vaccination rates continue to decline
April 21, 2019 - Researchers succeed in accelerating process of creating 3D images
April 21, 2019 - Tiny worm mimics key genetic risk for Alzheimer’s
April 21, 2019 - Angry dreams explained by brain waves
April 20, 2019 - Parenteral Antimicrobial Tx at Home Burdens Children’s Caregivers
April 20, 2019 - Diabetes treatment may keep dementia, Alzheimer’s at bay
April 20, 2019 - New bandage-like biosensor collects and analyzes sweat
April 20, 2019 - A comprehensive, centralized database of bovine milk compounds
April 20, 2019 - Two new epigenetic regulators maintain self-renewal of embryonic stem cells
April 20, 2019 - New Evidence That Veggies Beat Steak for Heart Health
April 20, 2019 - Study reveals genes associated with heavy drinking and alcoholism
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
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