Medical Design and Outsourcing

  • Home
  • Medical Device Business
    • Mergers & Acquisitions
    • Financial
    • Regulatory
  • Applications
    • Cardiovascular
    • Devices
    • Imaging
    • Implantables
    • Medical Equipment
    • Orthopedic
    • Surgical
  • Technologies
    • Supplies and Components Index
    • Contract Manufacturing
    • Components
    • Electronics
    • Extrusions
    • Materials
    • Motion Control
    • Prototyping
    • Pumps
    • Tubing
  • MedTech Resources
    • Medtech Events in 2025
    • The 2024 Medtech Big 100
    • Medical Device Handbook
    • MedTech 100 Index
    • Subscribe to Print Magazine
    • DeviceTalks
    • Digital Editions
    • eBooks
    • Educational Assets
    • Manufacturer Search
    • Podcasts
    • Print Subscription
    • Webinars / Digital Events
    • Whitepapers
    • Voices
    • Video
  • 2025 Leadership
    • 2024 Winners
    • 2023 Winners
    • 2022 Winners
    • 2021 Winners
  • Women in Medtech
  • Advertise
  • Subscribe

Prosthetic Valve Mismatches Common In Transcatheter Valve Replacement, Ups Risk Of Death

October 2, 2018 By University of Pennsylvania School of Medicine

In the largest multi-institutional study to date, led by researchers from Penn Medicine, the team found that among patients who underwent a transcatheter aortic valve replacement (TAVR), a high number experienced severe and moderate cases of prosthesis-patient mismatch (PPM) — meaning the implanted heart valve is too small for the patient which can lead to inadequate blood flow. The team also found that the risk of death and of heart failure readmissions were 19 percent and 12 percent higher, respectively, after one year as compared to patients without severe PPM.

Results of the study were presented today as a late-breaking abstract at the Transcatheter Cardiovascular Therapeutics (TCT) 2018 meeting in San Diego and simultaneously published online in the Journal of the American College of Cardiology.

“This is an important contemporary snapshot of what’s happening in the real world with commercial TAVR procedures,” says the study’s lead author Howard C. Herrmann, MD, FACC, MSCAI, the John W. Bryfogle Professor of Cardiovascular Medicine and Surgery at Penn’s Perelman School of Medicine and director of Penn Medicine’s Interventional Cardiology Program, who presented the results at TCT. “This is the first study that is large enough to demonstrate meaningful data associated with PPM for a relatively new procedure like TAVR. Based on these findings, PPM is an important problem in this population, one that deserves greater awareness among operators. And being aware of it is the first step in trying to prevent it.”

TAVR was approved by the Food and Drug Administration in 2011 for the treatment of aortic stenosis, a narrowing of the heart’s aortic valve, and has revolutionized valve replacement options for patients with this disease who are too sick or too high risk for surgical (open-heart) valve replacement (SAVR). This minimally invasive, catheter-based approach allows physicians to replace the aortic valve without need to remove the old, damaged one.

Of the 62,125 patients who received TAVRs in the United States between 2014 and 2017 and who were evaluated, researchers found 12 percent experienced severe PPM, while 25 percent had moderate PPM. Researchers collected and analyzed patient data from the U.S. STS/ACC Transcatheter Valve Therapy (TVT) Registry, which tracks all commercial procedures performed in the United States. To further study patient outcomes, the authors linked patients in the U.S. STS/ACC TVT registry to Centers for Medicare & Medicaid Services’ administrative claims data for 37,470 of their patients. After 30 days, patients with severe PPM had higher rates of heart failure hospitalization, stroke, and death.

Historically, PPM has been associated with worse outcomes after SAVR, however, less has been known about the incidence, outcomes, and predictors of PPM in TAVR patients. Past studies have been small, with limited follow up, and some from single centers — combined, they only represent 4,000 patients — and measurement techniques for the valve opening have been inconsistent.

PPM is a mismatch of the blood flow dynamics of the prosthetic valve and the amount of blood the heart needs to pump to the rest of the patient’s body. For example, having too small of a valve in a person with a large body surface area (height and weight) affects their ability to get enough blood flow when they exercise. In previous studies, severe PPM in both SAVR and TAVR patients have been associated with higher risk of death and hospital readmission, decreased exercise abilities, and a higher rate of valve deterioration over time.

The authors identified several predictors of PPM, including patients with a smaller valve prosthesis, those who had a larger body surface area, or patients who are female or younger.

“Severe PPM occurs frequently after TAVR procedures, and it results in worse outcomes, even after a short period of one year,” Herrmann says. “Now that we’re more aware of this, we need to look at strategies and compare devices and techniques in future studies to determine what will help us best limit this risk or avoid it in the future.”

Related Articles Read More >

This is a Zimmer Biomet marketing image of its Rosa robotic surgery system.
Zimmer Biomet seeks a ZBEdge for its Rosa robotic surgery
A photo of Capstan Medical's mitral valve implant, which uses nitinol.
Capstan Medical’s R&D head discusses the heart valve and robotics startup’s tech, engineering challenges and solutions, advice for others in medtech and how to join his team
An illustration of a neurosurgeon using a robotic endoscope to remove a brain tumor.
MDO Nitinol Innovation Special Report
A photo of Highridge Medical CEO Rebecca Whitney.
Highridge Medical is betting on this spine tech
“mdo
EXPAND YOUR KNOWLEDGE AND STAY CONNECTED
Get the latest medical device business news, application and technology trends.

DeviceTalks Weekly

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

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 our E-Newsletter
  • Listen to our Weekly Podcasts
  • Join our DeviceTalks Tuesdays Discussion

Copyright © 2025 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
    • Supplies and Components Index
    • Contract Manufacturing
    • Components
    • Electronics
    • Extrusions
    • Materials
    • Motion Control
    • Prototyping
    • Pumps
    • Tubing
  • MedTech Resources
    • Medtech Events in 2025
    • The 2024 Medtech Big 100
    • Medical Device Handbook
    • MedTech 100 Index
    • Subscribe to Print Magazine
    • DeviceTalks
    • Digital Editions
    • eBooks
    • Educational Assets
    • Manufacturer Search
    • Podcasts
    • Print Subscription
    • Webinars / Digital Events
    • Whitepapers
    • Voices
    • Video
  • 2025 Leadership
    • 2024 Winners
    • 2023 Winners
    • 2022 Winners
    • 2021 Winners
  • Women in Medtech
  • Advertise
  • Subscribe