(Press-News.org) The recalled Sprint Fidelis implantable cardioverter-defibrillator (ICD) leads (Medtronic) failed more often in younger patients, women, and individuals with hereditary heart disease, according to a multicenter study published online Jan. 17 in Circulation. The researchers found that lead failure was not associated with death or serious injuries.
However, about half of the patients whose leads fractured experienced painful inappropriate shocks, according to lead author Robert G. Hauser, MD, of the Minneapolis Heart Institute® at Abbott Northwestern Hospital. In a previous study, published in HeartRhythm in 2010, Hauser and colleagues found these inappropriate shocks could be mitigated by a software program available in Medtronic ICDs.
The manufacturer voluntarily removed Sprint Fidelis leads from the market in 2007 after 268,000 were implanted globally. Currently, more than 100,000 patients have Fidelis leads.
In this observational study, 1,023 Fidelis and 1,668 Quattro leads were implanted and followed at three centers (Minneapolis Heart Institute® in Minneapolis, Mayo Clinic in Rochester, Minn., and Beth Israel Deaconess Medical Center in Boston) from November 2001 to January 2009
"We were particularly interested in whether Fidelis leads were continuing to fail, in whom they were failing and what the implications might be for those patients," Hauser says. "We found that patients who were young and active with relatively normal pump function were at highest risk, as well as women compared with men."
The researchers found the failure rate for Fidelis leads was 2.81 percent per year, compared with 0.43 percent per year for Quattro Secure leads, also manufactured by Medtronic.. The authors described the Quattro failure rate as being "well below the suggested benchmark of 0.6 percent per year. The survival of Fidelis leads at four years was 87 percent, compared with 98.7 percent for Quattro leads
These findings could have significant implications for the management of patients who have Fidelis leads. While Fidelis continue to fail, Hauser and his colleagues conclude that there is currently no indication for arbitrarily replacing leads in patients who were indicated for ICDs, particularly due to the potential risk with the replacement procedures.
"Only in the hands of experienced operators should Fidelis lead replacement even be considered in these younger patients or women, who are expected to live with an ICD for a number of years," Hauser stresses.
###
This study was funded by research grants from the Minneapolis Heart Institute Foundation and the Abbott Northwestern Hospital Foundation.
Minneapolis Heart Institute®
The Minneapolis Heart Institute® is recognized internationally as one of the world's leading providers of heart and vascular care. This state-of-the-art facility combines the finest in personalized patient care with sophisticated technology in a unique, family-oriented environment. The Institute's programs, a number of which are conducted in conjunction with Abbott Northwestern Hospital, address the full range of heart and vascular health needs: prevention, diagnosis, treatment and rehabilitation.
Minneapolis Heart Institute Foundation
The Minneapolis Heart Institute Foundation is dedicated to creating a world without heart disease through groundbreaking clinical research and innovative education programs. MHIF's mission is to promote and improve cardiovascular health, quality of life and longevity for all.
END
Cancer researchers have discovered an important protein, produced naturally inside cells, that appears to suppress the growth of prostate cancer cells in the laboratory. The findings, published tomorrow in the journal Cancer Research, offer promising leads for research towards new treatments.
Prostate cancer is the most common cancer among men in the UK, with 37,500 men diagnosed with the disease every year. Many prostate cancers are slow growing, but in some cases the cancer is aggressive and spreads to other parts of the body, such as the bone. These cases are much ...
Boys predominantly pass on flu to other boys and girls to girls, according to a new study of how swine flu spread in a primary school during the 2009 pandemic, published today in the journal Proceedings of the National Academy of Sciences. The results also suggest that flu transmission is most intensive between children of the same class, but that sitting next to an infected person does not significantly increase a child's risk of catching flu. The data will help researchers to model how epidemics spread and how interventions such as school closures can help contain an ...
New Haven, Conn.—Triceratops and Torosaurus have long been considered the kings of the horned dinosaurs. But a new discovery traces the giants' family tree further back in time, when a newly discovered species appears to have reigned long before its more well-known descendants, making it the earliest known member of its family.
The new species, called Titanoceratops after the Greek myth of the Titans, rivaled Triceratops in size, with an estimated weight of nearly 15,000 pounds and a massive eight-foot-long skull.
Titanoceratops, which lived in the American southwest ...
Scientists have discovered why orchids are one of the most successful groups of flowering plants - it is all down to their relationships with the bees that pollinate them and the fungi that nourish them. The study, published tomorrow in the American Naturalist, is the culmination of a ten-year research project in South Africa involving researchers from Imperial College London, the Royal Botanic Gardens, Kew, and other international institutions.
The orchid family is one of the largest groups of flowering plants, with over 22,000 species worldwide. Today's research suggests ...
Using funding provided under the American Reinvestment and Recovery Act, the U.S. Department of Energy's Savannah River National Laboratory has launched a demonstration project near one of the Savannah River Site's former production reactor sites to clean up chemically contaminated groundwater, naturally.
A portion of the subsurface at the Site's P Area has become contaminated with chlorinated volatile organic compounds that are essentially like dry-cleaning fluid. SRNL and Clemson University have patented a consortium of microbes that have an appetite for that kind ...
INDIANAPOLIS – A School of Science at Indiana University-Purdue University Indianapolis biophysicist has developed a new method to identify communication pathways connecting distant regions within proteins.
With this tool, Andrew J. Rader, Ph.D., assistant professor of physics, has identified a mechanism for cooperative behavior within an entire molecule, a finding that suggests that in the future it may be possible to design drugs that target anywhere along the length of a molecule's communication pathway rather than only in a single location as they do today. The discovery ...
CORVALLIS, Ore. – Genetic research is showing that healthy steelhead runs in Pacific Northwest streams can depend heavily on the productivity of their stay-at-home counterparts, rainbow trout.
Steelhead and rainbow trout look different, grow differently, and one heads off to sea while the other never leaves home. But the life histories and reproductive health of wild trout and steelhead are tightly linked and interdependent, more so than has been appreciated, a new Oregon State University study concludes.
The research could raise new challenges for fishery managers ...
Numerous nanomaterials are currently at the focus of public attention. In particular silver nanoparticles are being investigated in detail, both by scientists as well as by the regulatory authorities. The assumption behind this interest is that they are dealing with a completely new substance. However, Empa researchers Bernd Nowack and Harald Krug, together with Murray Heights of the company HeiQ have shown in a paper recently published in the journal Environmental Science & Technology that nanosilver is by no means the discovery of the 21st century. Silver particles with ...
Offering the morning after pill free over the counter has not reduced the number of teenage pregnancies and may be associated with a rise in sexually-transmitted diseases (STIs), according to a report by experts at The University of Nottingham.
Professors David Paton and Sourafel Girma used local health authority data to study the impact that the introduction of Government-backed schemes to offer emergency birth control at pharmacies and without prescription have had on conception rates and the diagnosis of STIs among under-18s.
Their findings show that, on average, ...
Geneva, 31 January 2011. CERN today announced that the LHC will run through to the end of 2012 with a short technical stop at the end of 2011. The beam energy for 2011 will be 3.5 TeV. This decision, taken by CERN management following the annual planning workshop held in Chamonix last week and a report delivered today by the laboratory's machine advisory committee, gives the LHC's experiments a good chance of finding new physics in the next two years, before the LHC goes into a long shutdown to prepare for higher energy running starting 2014.
"If LHC continues to improve ...
