Medical Design and Outsourcing

  • Home
  • Medical Device Business
    • Mergers & Acquisitions
    • Financial
    • Regulatory
  • Applications
    • Cardiovascular
    • Devices
    • Imaging
    • Implantables
    • Medical Equipment
    • Orthopedic
    • Surgical
  • Technologies
    • Contract Manufacturing
    • Components
    • Electronics
    • Extrusions
    • Materials
    • Motion Control
    • Prototyping
    • Pumps
    • Tubing
  • Med Tech Resources
    • Subscribe to Print Magazine
    • DeviceTalks Tuesdays
    • Digital Editions
    • eBooks
    • Manufacturer Search
    • Medical Device Handbook
    • MedTech 100 Index
    • Podcasts
    • Print Subscription
    • The Big 100
    • Webinars / Digital Events
    • Whitepapers
    • Video
  • 2022 Leadership in MedTech
    • 2022 Leadership Voting!
    • 2021 Winners
    • 2020 Winners
  • Women in Medtech

Patients on Heartmate 3 Have Fewer Blood-Related Events Than Those on Heartmate II

April 7, 2017 By University of Chicago Medical Center

The HeartMate 3 Left Ventricular Assist System (LVAS) is an investigational chronic mechanical circulatory support (MCS) device intended for a broad range of advanced heart failure patients. (Credit: Abbott)

A six-month analysis of the pivotal MOMENTUM 3 trial found that patients implanted with the new HeartMate 3 left ventricular assist system (LVAS) had fewer adverse clotting and bleeding events than patients implanted with the control, HeartMate II LVAS.

In this randomized, non-blinded study, a multi-institutional team found that 69 percent of the 151 patients who received Abbott’s Heartmate 3 survived without any bleeding or clotting-related adverse events, compared to 55 percent of those who received the Heartmate II. Both devices are made by Abbott.

The results were announced April 6 in a late-breaking session at the 2017 meeting of the International Society for Heart and Lung Transplantation in San Diego and simultaneously published in the journal Circulation.

The researchers also devised a novel scoring system – the HemoCompatibility Score (HCS) – to quantify the burden of such events and their clinical relevance. Lower scores are better.

“For the HCS, mild events, such as two or fewer non-surgical bleeding episodes, receive one point,” explains Nir Uriel, MD, professor of medicine and director of the heart failure, transplant and mechanical circulatory support programs at the University of Chicago. “A non-disabling stroke is assessed at 2 points. An operation to replace the device gets 3 points. A disabling stroke gets 4 points.”

Patients with the HeartMate 3 had fewer of these adverse events – 28 percent of patients versus 38 percent for those on HeartMate II. Those on HeartMate 3 tended to have bleeding events, which are less likely to be severe. Those on HeartMate II had both bleeding and clotting events. They spent more time in the hospital.

There were 14 deaths overall in the first 30 days on the pump. Five of those patients were on the HeartMate 3; nine were on the HeartMate II.

The HeartMate 3 consequently scored numerically better on the HCS, collecting only 101 points, compared to 137 points acquired by the smaller group on HeartMate II. Those in whom the HCS score was higher, however, were less healthy overall. They were older, and also less likely to take aspirin to prevent blood clots.

Two thirds of the patients on the HeartMate 3 had no adverse events for six months, compared to half of those on the HeartMate II.

Overall, “patients implanted with the HeartMate 3 gained a significant increase in freedom from adverse events, driven predominantly by a reduction in non-disabling strokes and complete absence of pump thrombosis, compared with the HeartMate II,” says senior author Mandeep R. Mehra, MD, medical director of the Brigham and Women’s Hospital Heart and Vascular Center and chairman of the publications committee for MOMENTUM 3.

“No patients on the HeartMate 3 had pump-related clotting, requiring a pump reoperation,” Mehra notes. “There was also no difference in disabling strokes, a typically devastating complication.”

The Heartmate 3 has certain potential advantages because it was “designed to prevent thrombosis,” Uriel explained. It was engineered to be less destructive to blood cells as they are swept through the pump and into the aorta. “It has a frictionless rotor, wide gaps for permissive blood flow and reduced shear stress,” he says.

The study has significant limitations, the authors note. It followed a small number of patients for a limited time. It is difficult to distinguish between late post-operative bleeding, pre-existing issues such as a bleeding gastric ulcer, and early pump-related blood loss. The MOMENTUM 3 trial is “evaluating its long-term outcomes and hemocompatibility-related adverse-event profiles,” Mehra says. “These will become clearer in subsequent analyses.”

Related Articles Read More >

Thermedical's Durablate device has a handle with a blue light at one end and a catheter for scarring heart tissue
New method of cardiac ablation used in first in-human trial for ventricular tachycardia
Wire mesh that has captured a blood clot
How an Embotrap stent retriever thrombectomy treats ischemic strokes
An automated external defibrillator (AED) on a medical demonstration dummy
FDA adds AEDs and other medical devices to shortage list
Harvard SEAS image of biohybrid model of a four-chambered heart engineered with focused rotary jet spinning or FRJS
Harvard researchers are closer to human heart fabrication

DeviceTalks Weekly.

August 5, 2022
DTW Medtronic's Greg Smith lays out supply chain strategies
See More >

MDO Digital Edition

Digital Edition

Subscribe to Medical Design & Outsourcing. Bookmark, share and interact with the leading medical design engineering magazine today.

MEDTECH 100 INDEX

Medtech 100 logo
Market Summary > Current Price
The MedTech 100 is a financial index calculated using the BIG100 companies covered in Medical Design and Outsourcing.
DeviceTalks

DeviceTalks is a conversation among medical technology leaders. It's events, podcasts, webinars and one-on-one exchanges of ideas & insights.

DeviceTalks

New MedTech Resource

Medical Tubing

Enewsletter Subscriptions

Enewsletter Subscriptions

MassDevice

Mass Device

The Medical Device Business Journal. MassDevice is the leading medical device news business journal telling the stories of the devices that save lives.

Visit Website
MDO ad
Medical Design and Outsourcing
  • MassDevice
  • DeviceTalks
  • MedTech100 Index
  • Medical Tubing + Extrusion
  • Medical Design Sourcing
  • Drug Delivery Business News
  • Drug Discovery & Development
  • Pharmaceutical Processing World
  • R&D World
  • About Us/Contact
  • Advertise With Us
  • Subscribe to Print Magazine
  • Subscribe to E-newsletter
  • Attend our Monthly Webinars
  • Listen to our Weekly Podcasts
  • Join our DeviceTalks Tuesdays Discussion

Copyright © 2022 WTWH Media, LLC. All Rights Reserved. The material on this site may not be reproduced, distributed, transmitted, cached or otherwise used, except with the prior written permission of WTWH Media LLC. Site Map | Privacy Policy | RSS

Search Medical Design & Outsourcing

  • Home
  • Medical Device Business
    • Mergers & Acquisitions
    • Financial
    • Regulatory
  • Applications
    • Cardiovascular
    • Devices
    • Imaging
    • Implantables
    • Medical Equipment
    • Orthopedic
    • Surgical
  • Technologies
    • Contract Manufacturing
    • Components
    • Electronics
    • Extrusions
    • Materials
    • Motion Control
    • Prototyping
    • Pumps
    • Tubing
  • Med Tech Resources
    • Subscribe to Print Magazine
    • DeviceTalks Tuesdays
    • Digital Editions
    • eBooks
    • Manufacturer Search
    • Medical Device Handbook
    • MedTech 100 Index
    • Podcasts
    • Print Subscription
    • The Big 100
    • Webinars / Digital Events
    • Whitepapers
    • Video
  • 2022 Leadership in MedTech
    • 2022 Leadership Voting!
    • 2021 Winners
    • 2020 Winners
  • Women in Medtech