Welcome!

News Feed Item

New Aortic Valve Replacement Saves More Lives Than Open-Heart Surgery

At One Year, Patients Showed Significantly Lower Fatality and Improved Quality of Life

HARRISBURG, Pa., April 2, 2014 /PRNewswire-iReach/ -- Results from a groundbreaking study performed at PinnacleHealth were revealed this weekend at the American College of Cardiology's 2014 Scientific Sessions and simultaneously published in The New England Journal of Medicine.

(Photo: http://photos.prnewswire.com/prnh/20140402/MN95343)

"In patients with aortic valve stenosis, the self-expanding transaortic transcatheter aortic valve bioprosthesis implant, was associated with a significantly higher rate of survival after one year, than open heart surgical aortic valve replacement," states Brijeshwar Maini, MD, FACC, medical director of the PinnacleHealth Heart Valve Clinic.

Patients at PinnacleHealth Heart Valve Clinic participated in the Medtronic CoreValve® U.S. Pivotal Trial, which compared transcatheter aortic valve replacement (TAVR) using a self-expanding bioprosthesis to open heart surgical aortic valve replacement in patients with severe aortic stenosis, who are at "high risk" for surgery.

This is the first time a prospective, randomized study has shown transcatheter aortic valve replacement to be superior to open heart surgery. Patients in the trial had narrowed, failing aortic heart valves, called severe aortic stenosis.

In the study, physicians replaced diseased aortic valves in 747 patients, approximately half of who were randomized to the new minimally invasive CoreValve System, and half of whom were randomized to open heart surgery. The all-cause mortality rate was 14.2 percent in patients receiving the CoreValve System, compared to 19.1 percent in patients receiving surgery, a statistically significant finding at one year (the primary endpoint of the trial).

The rate of stroke, one of the complications most concerning to physicians and patients due to increased mortality, was low and produced similar results between the two groups of patients.

Patients also saw significant improvements in their quality of life. Quality of Life scores improved 19.0 points for CoreValve patients and 3.7 points for surgical patients at 30 days, and at one year both patient groups improved significantly, with CoreValve patients improving 23.2 points and surgical patients improving 21.9 points - as measured by Kansas City Cardiomyopathy Questionnaire (KCCQ) 100-point scale, where five points is considered improvement, and 20 points is considered a very large improvement.

"The CoreValve System is designed with self-expandable technology to replace a diseased aortic valve. It is placed percutaneously, meaning through the skin, usually through a small opening in the femoral artery, without open heart surgery or removal of the original valve. We then guide it into the heart at the site of the original aortic valve. Once in place, it takes over the original aortic valve's function and ensures that blood flows out of the heart freely without any obstruction," explains Dr. Maini.

The CoreValve System was approved by the U.S. Food and Drug Administration (FDA) in January 2014 for patients considered extreme risk for surgery. The device is not currently approved in the U.S. for use with patients at high risk. PinnacleHealth was actively involved in the extreme risk and high-risk trials and continues to participate in further research for those with intermediate risk.

Each year, nearly five million Americans are diagnosed with valve disease. Worldwide, approximately 300,000 people have been diagnosed with severe aortic stenosis and about one-third of this group has been found at too high a risk for traditional valve surgery. The CoreValve System is designed to provide a minimally invasive treatment option for patients with symptomatic, severe aortic valve stenosis.

"The results of this study are transforming the way we treat aortic stenosis. To participate in this trial and be a part of this revolutionary shift in medicine is exciting, but the true winners are our patients who will benefit from evidence-based medicine as we move forward," states Mubashir Mumtaz, MD, FACS, surgical director of the PinnacleHealth Heart Valve Clinic.

Primarily affecting the older population, aortic stenosis is a condition of the aortic valve that keeps the valve from opening and closing properly. This restricts healthy blood flow from the aorta to the rest of the body. While the heart initially compensates for stenosis by thickening its walls to help push blood through the valve, eventually this extra work weakens the heart and leads to an insufficient supply of oxygen-rich blood.

Symptoms of aortic valve stenosis can include fatigue, dizziness, chest pain or pressure, heart murmur, shortness of breath during activity, heart palpitations and fainting. Untreated, aortic valve stenosis can lead to serious heart problems including heart failure and even death. According to research, without effective treatment, as many as 50 percent of aortic stenosis patients with severe symptoms die within one year.

Media Contact: Kelly McCall, PinnacleHealth System, 717-231-8104, [email protected]

News distributed by PR Newswire iReach: https://ireach.prnewswire.com

SOURCE PinnacleHealth System

More Stories By PR Newswire

Copyright © 2007 PR Newswire. All rights reserved. Republication or redistribution of PRNewswire content is expressly prohibited without the prior written consent of PRNewswire. PRNewswire shall not be liable for any errors or delays in the content, or for any actions taken in reliance thereon.

Latest Stories
"Avere Systems is a hybrid cloud solution provider. We have customers that want to use cloud storage and we have customers that want to take advantage of cloud compute," explained Rebecca Thompson, VP of Marketing at Avere Systems, in this SYS-CON.tv interview at 18th Cloud Expo, held June 7-9, 2016, at the Javits Center in New York City, NY.
SYS-CON Events announced today that Dataloop.IO, an innovator in cloud IT-monitoring whose products help organizations save time and money, has been named “Bronze Sponsor” of SYS-CON's 20th International Cloud Expo®, which will take place on June 6-8, 2017, at the Javits Center in New York City, NY. Dataloop.IO is an emerging software company on the cutting edge of major IT-infrastructure trends including cloud computing and microservices. The company, founded in the UK but now based in San Fran...
Updating DevOps to the latest production data slows down your development cycle. Probably it is due to slow, inefficient conventional storage and associated copy data management practices. In his session at @DevOpsSummit at 20th Cloud Expo, Dhiraj Sehgal, in Product and Solution at Tintri, will talk about DevOps and cloud-focused storage to update hundreds of child VMs (different flavors) with updates from a master VM in minutes, saving hours or even days in each development cycle. He will also...
SYS-CON Events announced today that Linux Academy, the foremost online Linux and cloud training platform and community, will exhibit at SYS-CON's 20th International Cloud Expo®, which will take place on June 6-8, 2017, at the Javits Center in New York City, NY. Linux Academy was founded on the belief that providing high-quality, in-depth training should be available at an affordable price. Industry leaders in quality training, provided services, and student certification passes, its goal is to c...
20th Cloud Expo, taking place June 6-8, 2017, at the Javits Center in New York City, NY, will feature technical sessions from a rock star conference faculty and the leading industry players in the world. Cloud computing is now being embraced by a majority of enterprises of all sizes. Yesterday's debate about public vs. private has transformed into the reality of hybrid cloud: a recent survey shows that 74% of enterprises have a hybrid cloud strategy.
The unique combination of Amazon Web Services and Cloud Raxak, a Gartner Cool Vendor in IT Automation, provides a seamless and cost-effective way of securely moving on-premise IT workloads to Amazon Web Services. Any enterprise can now leverage the cloud, manage risk, and maintain continuous security compliance. Forrester's analysis shows that enterprises need automated security to lower security risk and decrease IT operational costs. Through the seamless integration into Amazon Web Services, ...
In the next five to ten years, millions, if not billions of things will become smarter. This smartness goes beyond connected things in our homes like the fridge, thermostat and fancy lighting, and into heavily regulated industries including aerospace, pharmaceutical/medical devices and energy. “Smartness” will embed itself within individual products that are part of our daily lives. We will engage with smart products - learning from them, informing them, and communicating with them. Smart produc...
"We provide DevOps solutions. We also partner with some key players in the DevOps space and we use the technology that we partner with to engineer custom solutions for different organizations," stated Himanshu Chhetri, CTO of Addteq, in this SYS-CON.tv interview at DevOps at 18th Cloud Expo, held June 7-9, 2016, at the Javits Center in New York City, NY.
Providing the needed data for application development and testing is a huge headache for most organizations. The problems are often the same across companies - speed, quality, cost, and control. Provisioning data can take days or weeks, every time a refresh is required. Using dummy data leads to quality problems. Creating physical copies of large data sets and sending them to distributed teams of developers eats up expensive storage and bandwidth resources. And, all of these copies proliferating...
“DevOps is really about the business. The business is under pressure today, competitively in the marketplace to respond to the expectations of the customer. The business is driving IT and the problem is that IT isn't responding fast enough," explained Mark Levy, Senior Product Marketing Manager at Serena Software, in this SYS-CON.tv interview at DevOps Summit, held Nov 4–6, 2014, at the Santa Clara Convention Center in Santa Clara, CA.
Hardware virtualization and cloud computing allowed us to increase resource utilization and increase our flexibility to respond to business demand. Docker Containers are the next quantum leap - Are they?! Databases always represented an additional set of challenges unique to running workloads requiring a maximum of I/O, network, CPU resources combined with data locality.
The speed of software changes in growing and large scale rapid-paced DevOps environments presents a challenge for continuous testing. Many organizations struggle to get this right. Practices that work for small scale continuous testing may not be sufficient as the requirements grow. In his session at DevOps Summit, Marc Hornbeek, Sr. Solutions Architect of DevOps continuous test solutions at Spirent Communications, explained the best practices of continuous testing at high scale, which is rele...
"We got started as search consultants. On the services side of the business we have help organizations save time and save money when they hit issues that everyone more or less hits when their data grows," noted Otis Gospodnetić, Founder of Sematext, in this SYS-CON.tv interview at @DevOpsSummit, held June 9-11, 2015, at the Javits Center in New York City.
"What is the next step in the evolution of IoT systems? The answer is data, information, which is a radical shift from assets, from things to input for decision making," stated Michael Minkevich, VP of Technology Services at Luxoft, in this SYS-CON.tv interview at @ThingsExpo, held November 3-5, 2015, at the Santa Clara Convention Center in Santa Clara, CA.
The emerging Internet of Everything creates tremendous new opportunities for customer engagement and business model innovation. However, enterprises must overcome a number of critical challenges to bring these new solutions to market. In his session at @ThingsExpo, Michael Martin, CTO/CIO at nfrastructure, outlined these key challenges and recommended approaches for overcoming them to achieve speed and agility in the design, development and implementation of Internet of Everything solutions with...