Navigation Links
Heart valve replacement without opening the chest gives new option for non-operable patients
Date:6/24/2011

(CHICAGO) An innovative approach for implanting a new aortic heart valve without open-heart surgery is being offered at Rush University Medical Center to patients with severe aortic stenosis who are at high-risk or not suitable candidates for open heart valve replacement surgery.

"This breakthrough technology could save the lives of thousands of patients with heart valve disease who have no other therapeutic options," says Dr. Ziyad Hijazi, director of the Rush Center for Congenital and Structural Heart Disease and interventional cardiologist of the Rush Valve Clinic.

The treatment is offered through a multi-center, phase IIB cohort study called the PARTNER II (Placement of AoRTic traNscathetER valves) trial.

Aortic valve stenosis (AS) is a type of valvular heart disease characterized by an abnormal narrowing of the aortic valve opening. It is a condition that affects nearly 1.5 million Americans. It causes hardening or thickening of the aortic valve leaflets, which limits leaflet motion and obstructs oxygen-rich blood flow from the heart to the rest of the body. Patients with severe AS may have symptoms of chest pain, fatigue, shortness of breath, lightheadedness or fainting. Although AS typically progresses slowly without symptoms, once symptoms occur, treatment is required. Fifty percent of patients may not survive beyond one to three years.

Traditionally, patients with symptomatic AS undergo aortic valve replacement during an open-heart surgery to alleviate symptoms, improve survival and improve quality of life. However, many patients who are at very high risk for surgery, such as elderly, frail individuals with multiple health concerns, are considered inoperable.

The PARTNER II trial will compare a pioneering technology called the Edwards SAPIEN XT valve, which is made of bovine pericardial tissue leaflets hand-sewn onto a metal frame, and a new catheter delivery system called the Edwards NovaFlex delivery system, which navigates the heart from a small incision to the femoral artery in a patient's leg or through a small incision between the ribs and snaked up into the left ventricle. The Edwards NovaFlex delivery system positions the catheter inside the patient's original, collapsed valve, using a balloon to deploy the frame, which holds the artificial valve in place in order to restore normal blood flow. Both procedures are performed on a beating heart, without the need for open, cardiopulmonary bypass and its associated risks.

Annually, some 200,000 people in the U.S. need a new heart valve, but nearly half of them do not receive a new valve for a variety of reasons.

"Past study results show conclusively that transcatheter valve replacement is a safe and effective alternative to open surgery, which remains the 'gold standard' for most patients," says Hijazi.

Results from the first phase of the PARTNER trial showed that the rate of death from any cause at one year was 50.7 percent in the patients who received standard therapy, as compared to 30.7 percent of patients treated with transcatheter aortic valve replacement (TAVR).

The transcatheter valve procedures take about 90 minutes, compared with four to six hours for open-heart surgery. In open-heart surgery, the surgeon cuts through the breastbone, stops the heart, removes the valve and replaces it. Open-heart surgery can require a two- to three-month recovery period, compared to only a few days for the transcatheter approach.

The next generation Edwards SAPIEN XT valve in The PARTNER II trial was engineered to provide a better valve patterned after surgical heart valves and potentially decrease treatment complications.

The PARTNER trial is the world's first randomized, controlled trial of a transcatheter aortic heart valve. In this clinical phase IIB cohort, patients are randomized to receive either the new Edwards Sapien XT valve using the NovaFlex delivery system or the Edwards SAPIEN Transcatheter Heart Valve.

"The primary objective of the trial is to reduce death, major stroke and repeat hospitalization in these patients," says Hijazi. "Additionally, we hope to improve quality-of-life indicators."

The PARTNER II trial is one of the three latest, nationwide clinical trials for minimally invasive heart valve replacement being offered through the Rush Valve Clinic, where a team of cardiac surgical and interventional experts address diseases of the aortic, mitral and pulmonary valves.

The three clinical trials include:

  • PARTNER II trial for patients with aortic stenosis
  • COMPASSION trial for patients with a dysfunctional conduit A phase II clinical trial using the SAPIEN Transcatheter Heart Valve in patients who have a dysfunctional conduit between the right ventricle and the pulmonary artery
  • EVEREST II trial for patients with mitral regurgitation A continued access trial using the eValve MitraClip to treat a mitral valve leak.


'/>"/>

Contact: Deb Song
deb_song@rush.edu
312-942-0588
Rush University Medical Center
Source:Eurekalert

Related medicine news :

1. Hospital Delays Tied to Racial Divide in Heart Attack Care
2. Angioplasty with stents may be safe in long-term for low-risk heart patients
3. Smoking During Pregnancy May Predispose Kids to Heart Trouble
4. Angioplasty may be feasible for liver transplantation candidates with heart disease
5. Cocaine-Related Heart Damage May Be Silent
6. Study shows pine bark naturally improves heart function
7. Delays in Hospital Transfers for Heart Attack Patients May Raise Death Risk
8. Black heart attack patients wait longer for advanced treatment, University of Michigan study shows
9. Heart disease beats breast cancer as the biggest killer
10. Gene Study Sheds Light on Often Fatal Heart Condition
11. Smoking-Cessation Drug Chantix Linked to Heart Problems
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:5/27/2016)... ... May 27, 2016 , ... Each year ... medicine. Allison Outerbridge is this year’s Life University winner of a ... the university’s Student Leadership Awards ceremony. , Outerbridge is approaching her last quarter ...
(Date:5/26/2016)... ... 26, 2016 , ... Cabot Corporation, Pfizer, and 3M are ... court documents and SEC filings. A jury has returned a verdict of ... Corporation, Case No. BC588866, Los Angeles County, California. The jury awarded $22.8 million ...
(Date:5/26/2016)... ... 2016 , ... The Woodlands at John Knox Village , Florida’s first ... for living and healing, celebrated its grand opening, today. The Woodlands at John Knox ... by Empowered Staff. , “This is an incredibly fulfilling time for John Knox Village ...
(Date:5/26/2016)... ... May 26, 2016 , ... ... the Foundation Fighting Blindness, Long Island Chapter on June 4, 2016, 1:30-3:30 pm ... Dr. Maisel, founder of Retina Group of New York , is a ...
(Date:5/26/2016)... ... May 26, 2016 , ... Eating Recovery Center, Washington ... opening a brand new child and adolescent residential treatment center on June 1. ... even more specialized eating disorder treatment and access to life-saving care. , To ...
Breaking Medicine News(10 mins):
(Date:5/24/2016)... 2016 ARANZ Medical  Ltd a ... sector, has been named the Coretex Hi-Tech Emerging Company of ... Dr Bruce Davey , CEO of ARANZ Medical ... really good to be recognised for the work we are ... used in 35 countries around the world from Sub-Saharan Africa ...
(Date:5/24/2016)... -- The innovator of COMBO ... s first dual therapy stent, introduces catheters for lower ... a global company specializing in the provision of life-changing ... to treat peripheral artery disease. The JADE™ and Scoreflex™ ... lower limb and arteriovenous (AV) fistula intervention. ...
(Date:5/24/2016)... May 24, 2016 Dutch surgeons have launched ... around the world and treat patients on a global scale. Medical ... , Asia and the US have already ... messaging and networking in a totally secure environment. Education  ... war zone working together with a surgeon at Harvard to treat ...
Breaking Medicine Technology: