Click here to close now.


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.


"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:

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
SYS-CON Events announced today that MobiDev, a software development company, will exhibit at the 17th International Cloud Expo®, which will take place November 3-5, 2015, at the Santa Clara Convention Center in Santa Clara, CA. MobiDev is a software development company with representative offices in Atlanta (US), Sheffield (UK) and Würzburg (Germany); and development centers in Ukraine. Since 2009 it has grown from a small group of passionate engineers and business managers to a full-scale mobi...
The broad selection of hardware, the rapid evolution of operating systems and the time-to-market for mobile apps has been so rapid that new challenges for developers and engineers arise every day. Security, testing, hosting, and other metrics have to be considered through the process. In his session at Big Data Expo, Walter Maguire, Chief Field Technologist, HP Big Data Group, at Hewlett-Packard, will discuss the challenges faced by developers and a composite Big Data applications builder, foc...
As enterprises capture more and more data of all types – structured, semi-structured, and unstructured – data discovery requirements for business intelligence (BI), Big Data, and predictive analytics initiatives grow more complex. A company’s ability to become data-driven and compete on analytics depends on the speed with which it can provision their analytics applications with all relevant information. The task of finding data has traditionally resided with IT, but now organizations increasingl...
Interested in leveraging automation technologies and a cloud architecture to make developers more productive? Learn how PaaS can benefit your organization to help you streamline your application development, allow you to use existing infrastructure and improve operational efficiencies. Begin charting your path to PaaS with OpenShift Enterprise.
SYS-CON Events announced today that Agema Systems will exhibit at the 17th International Cloud Expo®, which will take place on November 3-5, 2015, at the Santa Clara Convention Center in Santa Clara, CA. Agema Systems is the leading provider of critical white-box rack solutions to data centers through the major integrators and value added distribution channels.
The cloud has reached mainstream IT. Those 18.7 million data centers out there (server closets to corporate data centers to colocation deployments) are moving to the cloud. In his session at 17th Cloud Expo, Achim Weiss, CEO & co-founder of ProfitBricks, will share how two companies – one in the U.S. and one in Germany – are achieving their goals with cloud infrastructure. More than a case study, he will share the details of how they prioritized their cloud computing infrastructure deployments ...
Data loss happens, even in the cloud. In fact, if your company has adopted a cloud application in the past three years, data loss has probably happened, whether you know it or not. In his session at 17th Cloud Expo, Bryan Forrester, Senior Vice President of Sales at eFolder, will present how common and costly cloud application data loss is and what measures you can take to protect your organization from data loss.
Decisions about budgets and resources are often made without IT even having a seat at the table. As technologist we understand the value of DevOps - but do your business counterparts? If they don't, your DevOps initiatives could lose funding before they start. In her session at DevOps Summit, Jeanne Morain, Strategist / Author at iSpeak Cloud, LLC, will provide insights on how to bridge the gap between business and technology leaders. Attendees will learn prescriptive guidance on balancing wor...
Organizations already struggle with the simple collection of data resulting from the proliferation of IoT, lacking the right infrastructure to manage it. They can't only rely on the cloud to collect and utilize this data because many applications still require dedicated infrastructure for security, redundancy, performance, etc. In his session at 17th Cloud Expo, Emil Sayegh, CEO of Codero Hosting, will discuss how in order to resolve the inherent issues, companies need to combine dedicated a...
The modern software development landscape consists of best practices and tools that allow teams to deliver software in a near-continuous manner. By adopting a culture of automation, measurement and sharing, the time to ship code has been greatly reduced, allowing for shorter release cycles and quicker feedback from customers and users. Still, with all of these tools and methods, how can teams stay on top of what is taking place across their infrastructure and codebase? Hopping between services a...
For almost two decades, businesses have discovered great opportunities to engage with customers and even expand revenue through digital systems, including web and mobile applications. Yet, even now, the conversation between the business and the technologists that deliver these systems is strained, in large part due to misaligned objectives. In his session at DevOps Summit, James Urquhart, Senior Vice President of Performance Analytics at SOASTA, Inc., will discuss how measuring user outcomes –...
Clearly the way forward is to move to cloud be it bare metal, VMs or containers. One aspect of the current public clouds that is slowing this cloud migration is cloud lock-in. Every cloud vendor is trying to make it very difficult to move out once a customer has chosen their cloud. In his session at 17th Cloud Expo, Naveen Nimmu, CEO of Clouber, Inc., will advocate that making the inter-cloud migration as simple as changing airlines would help the entire industry to quickly adopt the cloud wit...
While testing is often ignored when it comes to DevOps - it could be the most important aspect of achieving true DevOps success. Without rethinking automated testing from the ground-up, the entire DevOps productivity gain cannot be realized. Large tech companies build their own rapid test automation that runs in minutes across functional, performance, security and other tests. In his session at DevOps Summit, Kevin Surace, CEO of Appvance, will discuss how we learn from these real-world succe...
SYS-CON Events announced today that VividCortex, the monitoring solution for the modern data system, will exhibit at the 17th International Cloud Expo®, which will take place on November 3–5, 2015, at the Santa Clara Convention Center in Santa Clara, CA. The database is the heart of most applications, but it’s also the part that’s hardest to scale, monitor, and optimize even as it’s growing 50% year over year. VividCortex is the first unified suite of database monitoring tools specifically desi...
Apps and devices shouldn't stop working when there's limited or no network connectivity. Learn how to bring data stored in a cloud database to the edge of the network (and back again) whenever an Internet connection is available. In his session at 17th Cloud Expo, Bradley Holt, Developer Advocate at IBM Cloud Data Services, will demonstrate techniques for replicating cloud databases with devices in order to build offline-first mobile or Internet of Things (IoT) apps that can provide a better, ...