Forum for Science, Industry and Business

Sponsored by:     3M 
Search our Site:

 

Clinical guidelines for recalled pacemakers and implantable cardioverter-defibrillators developed

26.07.2006
A team of medical experts led by a Virginia Commonwealth University researcher has established a set of clinical guidelines to help physicians determine how to best care for patients with pacemakers or implantable cardioverter-defibrillators (ICDs) that are the subject of an advisory or recall.

The research team, led by Mitesh S. Amin, M.D., a resident in the Department of Internal Medicine at the VCU School of Medicine, developed the guidelines, which appear in the July 26 issue of the Journal of the American Medical Association.

“There is limited information to direct patient management after an implantable device has been subject to an FDA advisory,” said Kenneth Ellenbogen, M.D., director of VCU’s cardiac electrophysiology lab and senior author of the study. “These guidelines can give physicians a better understanding of the risks and benefits of device replacement compared to continued clinical follow-up.”

In the analysis, the researchers considered the potential outcomes in deciding whether to immediately replace a device under advisory or to continue follow-up without replacement.

In determining the best management approach, the researchers constructed a decision analysis model to evaluate the risks and benefits associated with device replacement or continued monitoring.

The study considered variables including indications for device implantation, anticipated course following device failure, device failure rates from the advisory and device replacement mortality rates per procedure.

According to Ellenbogen, the findings suggest device replacement in the setting of an advisory is not inconsequential and frequently has a greater risk than continued device follow-up. The decision to replace a recalled device should be based primarily on the device failure rate, the degree of patient dependency and the anticipated mortality from device replacement.

“We ultimately want the best care for patients with implantable devices and having a rational mechanism to approach these patients is critical to patient care,” said Ellenbogen.

Ellenbogen and Amin collaborated with Mark Wood, M.D., VCU professor of internal medicine, and David Matchar, M.D., professor of medicine at Duke University.

According to the study, there are approximately 2 million patients with ICDs and pacemakers worldwide that often are implanted for life threatening conditions – pacemakers for patients with complete heart block and ICDs to provide therapy for patients at risk for cardiac arrest. Advisories typically arise from unanticipated device failures which are identified after product release and widespread clinical use.

EDITOR’S NOTE: For a copy of the study, contact JAMA at mediarelations@jama-archives.org, or call 312-464-JAMA.

Malorie Janis | EurekAlert!
Further information:
http://www.vcu.edu

More articles from Health and Medicine:

nachricht Fast-tracking T cell therapies with immune-mimicking biomaterials
16.01.2018 | Wyss Institute for Biologically Inspired Engineering at Harvard

nachricht Dengue takes low and slow approach to replication
12.01.2018 | Duke University

All articles from Health and Medicine >>>

The most recent press releases about innovation >>>

Die letzten 5 Focus-News des innovations-reports im Überblick:

Im Focus: Scientists decipher key principle behind reaction of metalloenzymes

So-called pre-distorted states accelerate photochemical reactions too

What enables electrons to be transferred swiftly, for example during photosynthesis? An interdisciplinary team of researchers has worked out the details of how...

Im Focus: The first precise measurement of a single molecule's effective charge

For the first time, scientists have precisely measured the effective electrical charge of a single molecule in solution. This fundamental insight of an SNSF Professor could also pave the way for future medical diagnostics.

Electrical charge is one of the key properties that allows molecules to interact. Life itself depends on this phenomenon: many biological processes involve...

Im Focus: Paradigm shift in Paris: Encouraging an holistic view of laser machining

At the JEC World Composite Show in Paris in March 2018, the Fraunhofer Institute for Laser Technology ILT will be focusing on the latest trends and innovations in laser machining of composites. Among other things, researchers at the booth shared with the Aachen Center for Integrative Lightweight Production (AZL) will demonstrate how lasers can be used for joining, structuring, cutting and drilling composite materials.

No other industry has attracted as much public attention to composite materials as the automotive industry, which along with the aerospace industry is a driver...

Im Focus: Room-temperature multiferroic thin films and their properties

Scientists at Tokyo Institute of Technology (Tokyo Tech) and Tohoku University have developed high-quality GFO epitaxial films and systematically investigated their ferroelectric and ferromagnetic properties. They also demonstrated the room-temperature magnetocapacitance effects of these GFO thin films.

Multiferroic materials show magnetically driven ferroelectricity. They are attracting increasing attention because of their fascinating properties such as...

Im Focus: A thermometer for the oceans

Measurement of noble gases in Antarctic ice cores

The oceans are the largest global heat reservoir. As a result of man-made global warming, the temperature in the global climate system increases; around 90% of...

All Focus news of the innovation-report >>>

Anzeige

Anzeige

Event News

10th International Symposium: “Advanced Battery Power – Kraftwerk Batterie” Münster, 10-11 April 2018

08.01.2018 | Event News

See, understand and experience the work of the future

11.12.2017 | Event News

Innovative strategies to tackle parasitic worms

08.12.2017 | Event News

 
Latest News

White graphene makes ceramics multifunctional

16.01.2018 | Materials Sciences

Breaking bad metals with neutrons

16.01.2018 | Materials Sciences

ISFH-CalTeC is “designated test centre” for the confirmation of solar cell world records

16.01.2018 | Power and Electrical Engineering

VideoLinks
B2B-VideoLinks
More VideoLinks >>>