Featured Research

from universities, journals, and other organizations

Doctors implant first new valve device in heart patient after FDA approval

Date:
January 23, 2014
Source:
Beth Israel Deaconess Medical Center
Summary:
American doctors yesterday became the first to use a new minimally invasive medical device since it received FDA approval last week. The device treats patients with severely damaged aortic heart valves who are too ill or frail to have their aortic valves replaced through traditional open-heart surgery.

Beth Israel Deaconess Medical Center (BIDMC) yesterday became the first institution in the United States to use a new minimally invasive medical device since it received FDA approval last week. The device treats patients with severely damaged aortic heart valves who are too ill or frail to have their aortic valves replaced through traditional open-heart surgery.

Related Articles


The first commercial implant of the CoreValve System was performed in an 84-year-old man by a multidisciplinary team of interventional cardiologists and cardiac surgeons from the CardioVascular Institute team at BIDMC. The team used a non-surgical, "transfemoral" technique to place the CoreValve in the man's heart through a catheter (tube) inserted in the femoral artery of his groin.

The CoreValve team includes interventional cardiologists Jeffrey Popma, MD, Roger Laham, MD, and Duane Pinto, MD; cardiac surgeons Kamal Khabbaz, MD, and David Liu, MD; and program coordinator Kim Guibone, NP. Dr. Popma is the co-principal investigator of the national CoreValve U.S. Pivotal Trial, the clinical study that led to its recent US Food and Drug Administration (FDA) approval.

Positive Clinical Performance

The FDA approved the device for use in patients with aortic stenosis based on its exceptionally positive clinical performance and its ability to lengthen life and reduce the rate of common complications -- such as stroke and valve leakage -- that have a dramatic impact on patients' quality of life.

Approximately one-third of severe aortic stenosis patients are not eligible for open-heart surgery because in their weak condition, their doctors deem the risk to be unacceptable. Unless these patients are treated, however, they have a 50 percent risk of death at one year. When calcium deposits cause the aortic valve to become stenotic, or narrowed, it cannot open and close properly, diminishing blood flow between the heart and the rest of the body. This causes the heart to weaken and function poorly. Symptoms of aortic stenosis include fatigue, dizziness, chest pain and pressure, shortness of breath during activity, heart palpitations and fainting.

Severe aortic stenosis primarily affects older people and typically develops when the patient is 50 to 70 years of age. Approximately 300,000 people worldwide, including 100,000 in the United States, suffer from severe aortic stenosis.

"This implant marks a significant milestone in our institution's history as we've been instrumental in confirming the safety and efficacy of this new device, and ultimately providing a viable new therapy to patients who otherwise have limited or no options," said Khabbaz, co-principal investigator for the local trial that took place at BIDMC.

Popma added, "Through the strength of our multi-disciplinary approach at the BIDMC, our patients will now have access to this life-saving therapy and the improved quality of life it allows."

Beth Israel Deaconess was one of 40 centers across the United States that participated in the clinical trial and continues to be involved in research on future improvements in this technology.

Beth Israel Deaconess is the only hospital in the Boston area currently offering CoreValve therapy. It also offers the Edwards Sapien valve, the first of the two devices (including the CoreValve) the FDA has approved for transfemoral aortic valve replacement. The program is part of the Structural Heart Center, a multidisciplinary initiative of the CardioVascular Institute and the Divisions of Cardiac Surgery and Cardiology that began in 2010.

Takes Over Valve Function

Most commonly, the Medtronic CoreValve System is inserted into a patient via an artery in the leg, and the physician then guides it through the arteries into the heart at the site of the original aortic valve. Once in place, it takes over the original valve's function and ensures that oxygen-rich blood flows out of the heart efficiently to circulate throughout the body.

The advanced design of the new device was developed to serve a broad spectrum of severe aortic stenosis patients. The CoreValve System is suitable for patients with native valves of nearly all sizes, and it is delivered via the smallest delivery system available (18 French, or approximately a quarter-inch), making it possible to treat patients with vascular systems that are small or difficult to navigate. Additionally, the CoreValve System enables physicians to deliver the device to the diseased valve in a controlled manner, allowing for accurate placement.


Story Source:

The above story is based on materials provided by Beth Israel Deaconess Medical Center. Note: Materials may be edited for content and length.


Cite This Page:

Beth Israel Deaconess Medical Center. "Doctors implant first new valve device in heart patient after FDA approval." ScienceDaily. ScienceDaily, 23 January 2014. <www.sciencedaily.com/releases/2014/01/140123154756.htm>.
Beth Israel Deaconess Medical Center. (2014, January 23). Doctors implant first new valve device in heart patient after FDA approval. ScienceDaily. Retrieved November 24, 2014 from www.sciencedaily.com/releases/2014/01/140123154756.htm
Beth Israel Deaconess Medical Center. "Doctors implant first new valve device in heart patient after FDA approval." ScienceDaily. www.sciencedaily.com/releases/2014/01/140123154756.htm (accessed November 24, 2014).

Share This


More From ScienceDaily



More Health & Medicine News

Monday, November 24, 2014

Featured Research

from universities, journals, and other organizations


Featured Videos

from AP, Reuters, AFP, and other news services

Ebola-Hit Sierra Leone's Late Cocoa Leaves Bitter Taste

Ebola-Hit Sierra Leone's Late Cocoa Leaves Bitter Taste

AFP (Nov. 23, 2014) The arable district of Kenema in Sierra Leone -- at the centre of the Ebola outbreak in May -- has been under quarantine for three months as the cocoa harvest comes in. Duration: 01:32 Video provided by AFP
Powered by NewsLook.com
Don't Fall For Flu Shot Myths

Don't Fall For Flu Shot Myths

Newsy (Nov. 23, 2014) Misconceptions abound when it comes to your annual flu shot. Medical experts say most people older than 6 months should get the shot. Video provided by Newsy
Powered by NewsLook.com
WFP: Ebola Risks Heightened Among Women Throughout Africa

WFP: Ebola Risks Heightened Among Women Throughout Africa

AFP (Nov. 21, 2014) Having children has always been a frightening prospect in Sierra Leone, the world's most dangerous place to give birth, but Ebola has presented an alarming new threat for expectant mothers. Duration: 00:37 Video provided by AFP
Powered by NewsLook.com
Could Your Genes Be The Reason You're Single?

Could Your Genes Be The Reason You're Single?

Newsy (Nov. 21, 2014) Researchers in Beijing discovered a gene called 5-HTA1, and carriers are reportedly 20 percent more likely to be single. Video provided by Newsy
Powered by NewsLook.com

Search ScienceDaily

Number of stories in archives: 140,361

Find with keyword(s):
Enter a keyword or phrase to search ScienceDaily for related topics and research stories.

Save/Print:
Share:

Breaking News:

Strange & Offbeat Stories


Health & Medicine

Mind & Brain

Living & Well

In Other News

... from NewsDaily.com

Science News

Health News

Environment News

Technology News



Save/Print:
Share:

Free Subscriptions


Get the latest science news with ScienceDaily's free email newsletters, updated daily and weekly. Or view hourly updated newsfeeds in your RSS reader:

Get Social & Mobile


Keep up to date with the latest news from ScienceDaily via social networks and mobile apps:

Have Feedback?


Tell us what you think of ScienceDaily -- we welcome both positive and negative comments. Have any problems using the site? Questions?
Mobile: iPhone Android Web
Follow: Facebook Twitter Google+
Subscribe: RSS Feeds Email Newsletters
Latest Headlines Health & Medicine Mind & Brain Space & Time Matter & Energy Computers & Math Plants & Animals Earth & Climate Fossils & Ruins