|By PR Newswire||
|April 2, 2014 09:15 AM EDT||
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: https://ireach.prnewswire.com
SOURCE PinnacleHealth System
SYS-CON Events announced today that G2G3 will exhibit at SYS-CON's @DevOpsSummit Silicon Valley, which will take place on November 3–5, 2015, at the Santa Clara Convention Center in Santa Clara, CA. Based on a collective appreciation for user experience, design, and technology, G2G3 is uniquely qualified and motivated to redefine how organizations and people engage in an increasingly digital world.
Sep. 1, 2015 03:00 PM EDT Reads: 507
SYS-CON Events announced today that IceWarp 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. IceWarp, the leader of cloud and on-premise messaging, delivers secured email, chat, documents, conferencing and collaboration to today's mobile workforce, all in one unified interface
Sep. 1, 2015 03:00 PM EDT Reads: 439
In 2014, the market witnessed a massive migration to the cloud as enterprises finally overcame their fears of the cloud’s viability, security, etc. Over the past 18 months, AWS, Google and Microsoft have waged an ongoing battle through a wave of price cuts and new features. For IT executives, sorting through all the noise to make the best cloud investment decisions has become daunting. Enterprises can and are moving away from a "one size fits all" cloud approach. The new competitive field has ...
Sep. 1, 2015 02:45 PM EDT
In his session at @ThingsExpo, Lee Williams, a producer of the first smartphones and tablets, will talk about how he is now applying his experience in mobile technology to the design and development of the next generation of Environmental and Sustainability Services at ETwater. He will explain how M2M controllers work through wirelessly connected remote controls; and specifically delve into a retrofit option that reverse-engineers control codes of existing conventional controller systems so the...
Sep. 1, 2015 02:45 PM EDT Reads: 135
Everyone talks about continuous integration and continuous delivery but those are just two ends of the pipeline. In the middle of DevOps is continuous testing (CT), and many organizations are struggling to implement continuous testing effectively. After all, without continuous testing there is no delivery. And Lab-As-A-Service (LaaS) enhances the CT with dynamic on-demand self-serve test topologies. CT together with LAAS make a powerful combination that perfectly serves complex software developm...
Sep. 1, 2015 02:30 PM EDT Reads: 210
The Internet of Things is in the early stages of mainstream deployment but it promises to unlock value and rapidly transform how organizations manage, operationalize, and monetize their assets. IoT is a complex structure of hardware, sensors, applications, analytics and devices that need to be able to communicate geographically and across all functions. Once the data is collected from numerous endpoints, the challenge then becomes converting it into actionable insight.
Sep. 1, 2015 01:00 PM EDT
With the proliferation of connected devices underpinning new Internet of Things systems, Brandon Schulz, Director of Luxoft IoT – Retail, will be looking at the transformation of the retail customer experience in brick and mortar stores in his session at @ThingsExpo. Questions he will address include: Will beacons drop to the wayside like QR codes, or be a proximity-based profit driver? How will the customer experience change in stores of all types when everything can be instrumented and a...
Sep. 1, 2015 12:45 PM EDT Reads: 474
SYS-CON Events announced today that HPM Networks 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. For 20 years, HPM Networks has been integrating technology solutions that solve complex business challenges. HPM Networks has designed solutions for both SMB and enterprise customers throughout the San Francisco Bay Area.
Sep. 1, 2015 12:30 PM EDT Reads: 909
This Enterprise Strategy Group lab validation report of the NEC Express5800/R320 server with Intel® Xeon® processor presents the benefits of 99.999% uptime NEC fault-tolerant servers that lower overall virtualized server total cost of ownership. This report also includes survey data on the significant costs associated with system outages impacting enterprise and web applications. Click Here to Download Report Now!
Sep. 1, 2015 12:30 PM EDT Reads: 256
Enterprises can achieve rigorous IT security as well as improved DevOps practices and Cloud economics by taking a new, cloud-native approach to application delivery. Because the attack surface for cloud applications is dramatically different than for highly controlled data centers, a disciplined and multi-layered approach that spans all of your processes, staff, vendors and technologies is required. This may sound expensive and time consuming to achieve as you plan how to move selected applicati...
Sep. 1, 2015 12:30 PM EDT
Consumer IoT applications provide data about the user that just doesn’t exist in traditional PC or mobile web applications. This rich data, or “context,” enables the highly personalized consumer experiences that characterize many consumer IoT apps. This same data is also providing brands with unprecedented insight into how their connected products are being used, while, at the same time, powering highly targeted engagement and marketing opportunities. In his session at @ThingsExpo, Nathan Trel...
Sep. 1, 2015 12:15 PM EDT Reads: 249
Whether you like it or not, DevOps is on track for a remarkable alliance with security. The SEC didn’t approve the merger. And your boss hasn’t heard anything about it. Yet, this unruly triumvirate will soon dominate and deliver DevSecOps faster, cheaper, better, and on an unprecedented scale. In his session at DevOps Summit, Frank Bunger, VP of Customer Success at ScriptRock, will discuss how this cathartic moment will propel the DevOps movement from such stuff as dreams are made on to a prac...
Sep. 1, 2015 12:00 PM EDT Reads: 237
Through WebRTC, audio and video communications are being embedded more easily than ever into applications, helping carriers, enterprises and independent software vendors deliver greater functionality to their end users. With today’s business world increasingly focused on outcomes, users’ growing calls for ease of use, and businesses craving smarter, tighter integration, what’s the next step in delivering a richer, more immersive experience? That richer, more fully integrated experience comes ab...
Sep. 1, 2015 11:45 AM EDT Reads: 673
SYS-CON Events announced today that Pythian, a global IT services company specializing in helping companies leverage disruptive technologies to optimize revenue-generating systems, has been named “Bronze Sponsor” of SYS-CON's 17th Cloud Expo, which will take place on November 3–5, 2015, at the Santa Clara Convention Center in Santa Clara, CA. Founded in 1997, Pythian is a global IT services company that helps companies compete by adopting disruptive technologies such as cloud, Big Data, advance...
Sep. 1, 2015 11:45 AM EDT Reads: 320
Organizations from small to large are increasingly adopting cloud solutions to deliver essential business services at a much lower cost. According to cyber security experts, the frequency and severity of cyber-attacks are on the rise, causing alarm to businesses and customers across a variety of industries. To defend against exploits like these, a company must adopt a comprehensive security defense strategy that is designed for their business. In 2015, organizations such as United Airlines, Sony...
Sep. 1, 2015 11:45 AM EDT Reads: 491