05.11.2012 Views

DeBAKEy CARDIOvASCuLAR JOuRNAL - Methodist Hospital

DeBAKEy CARDIOvASCuLAR JOuRNAL - Methodist Hospital

DeBAKEy CARDIOvASCuLAR JOuRNAL - Methodist Hospital

SHOW MORE
SHOW LESS

You also want an ePaper? Increase the reach of your titles

YUMPU automatically turns print PDFs into web optimized ePapers that Google loves.

The <strong>Methodist</strong> <strong>Hospital</strong><br />

chosen for percutaneous<br />

valve replacement study<br />

Study evaluates replacing<br />

heart valve through tiny<br />

puncture hole<br />

MetHodist de Bakey Heart & VasCular Center update<br />

HOuSTON (Jan. 24, 2011) —<br />

The <strong>Methodist</strong> DeBakey Heart &<br />

vascular Center was chosen today<br />

as a site for a critical percutaneous<br />

heart valve study. As part of the<br />

research study, <strong>Methodist</strong> physicians<br />

will replace diseased cardiac<br />

valves through a single, tiny puncture<br />

hole in the research subject’s<br />

groin.<br />

“using this new technique in the<br />

study, we will be able to replace<br />

severely calcified and damaged<br />

aortic valves without open heart<br />

surgery or removal of the original<br />

diseased valve,” said Dr. Neal<br />

Kleiman, director of the catheterization<br />

labs at the <strong>Methodist</strong><br />

DeBakey Heart & vascular Center<br />

and cardiology principal investigator<br />

for the trial. “This study is the<br />

only way individuals have access<br />

to this technique in the united<br />

States.”<br />

The Medtronic Corevalve ®<br />

System, which is delivered into<br />

the individual’s heart via catheter,<br />

has been implanted in more than<br />

12,000 patients worldwide and is<br />

available in 34 countries outside<br />

the united States.<br />

The trial incorporates expertise<br />

of both cardiac surgeons and cardiologists.<br />

using this technique,<br />

physicians make a tiny puncture<br />

hole in the individual’s groin and<br />

In the news<br />

thread a catheter through the<br />

femoral artery into the heart. The<br />

valve is delivered to the site of the<br />

diseased aortic valve through the<br />

catheter, and then the new valve<br />

is deployed inside the individual’s<br />

original valve, thus providing the<br />

individual with a functioning valve<br />

to allow for effective blood flow.<br />

“We routinely perform surgical<br />

valve replacement for diseased<br />

aortic valves, but many individuals<br />

are too high a risk for open-heart<br />

surgery due to age or other illness,<br />

said Dr. Michael Reardon, cardiac<br />

surgeon at <strong>Methodist</strong> and surgical<br />

principal investigator for the<br />

trial. “In this trial, we will evaluate<br />

whether catheter based aortic valve<br />

replacement will help extend the<br />

lives of this group of individuals.”<br />

Worldwide, approximately<br />

300,000 people have been diagnosed<br />

with this condition (100,000<br />

in the united States), and approximately<br />

one-third of these patients<br />

are deemed at too high a risk for<br />

open-heart surgery,[i] the only therapy<br />

with significant clinical effect<br />

that is currently available in the<br />

united States.<br />

Traditionally, a valve is replaced<br />

with a tissue or mechanical valve<br />

during open-heart surgery, which<br />

requires a surgical incision and<br />

a one month recovery period.<br />

Transcatheter valve replacement<br />

is being studied in part to evaluate<br />

recovery times and exposure to<br />

side affects of major surgery.<br />

In July, <strong>Methodist</strong> opened a new<br />

hybrid, robotic operating suite that<br />

integrates advanced robotics, imag-<br />

ing and navigation with surgery to<br />

offer patients the least invasive and<br />

safest surgical and interventional<br />

treatments for cardiovascular disease.<br />

“The new suite is perfectly<br />

designed for advanced procedures<br />

like the percutaneous valve,” said<br />

Dr. Alan Lumsden, medical director<br />

of the <strong>Methodist</strong> DeBakey<br />

Heart & vascular Center in<br />

Houston. “The clear 3-D imaging<br />

we have in this new room enables<br />

us to maneuver the valve into<br />

place and position it much more<br />

accurately and precisely than ever<br />

before. This is vitally important in<br />

such an advanced technique.”<br />

<strong>Methodist</strong> will be one of 40 sites<br />

in the country studying this new<br />

technique. The study investigators<br />

are currently screening subjects for<br />

enrollment. <strong>Methodist</strong> will enroll<br />

approximately 100 patients over the<br />

course of the trial. The Medtronic<br />

Corevalve u.S. Pivotal Clinical<br />

Trial will enroll a total of more<br />

than 1,300 patients in the united<br />

States. Outside the united States,<br />

Corevalve received CE (Conformité<br />

Européenne) Mark in Europe in<br />

2007.<br />

For more information on the<br />

<strong>Methodist</strong> DeBakey Heart &<br />

vascular Center, visit www.<br />

debakeyheartcenter.com.<br />

[i] Iung B, Cachier A, Baron G, et al.<br />

Decision-making in elderly patients<br />

with severe aortic stenosis: why are<br />

so many denied surgery? Eur Heart J.<br />

2003;26:2714-2720.<br />

56 vII (1) 2011 | MDCvJ

Hooray! Your file is uploaded and ready to be published.

Saved successfully!

Ooh no, something went wrong!