News | June 04, 2010

Transcatheter Aortic Valve Shows Positive One-Year Outcomes

June 4, 2010 – One-year mortality rates were very low for 1,038 high-risk patients, many of whom were too sick to undergo traditional open-heart surgery, who received the Sapien transcatheter heart valve. Results of the SOURCE Registry were presented last week at EuroPCR in Paris.

The registry is the largest reported experience in the world with one-year adjudicated data on consecutive patients treated with transcatheter heart valves. It showed a one-year survival rate of 81.1 percent in transfemoral procedures (valve delivered via the femoral artery) and 72.1 percent in transapical procedures (valve delivered via a small incision through the ribs).

"The encouraging outcomes add to the evolving body of clinical evidence that demonstrates transcatheter aortic valve implantation is a viable option for this high-risk patient population. The data provide valuable, real world insights that enable the continued advancement of this important treatment for patients in need of alternative therapies to traditional open-heart surgery," said Martyn Thomas, M.D., director of cardiothoracic services, Guys and St. Thomas' National Health Service (NHS) Foundation Trust in London.

The SOURCE Registry includes outcomes data from 100 percent of patients treated with the Edwards Sapien transcatheter heart valve at 32 European centers from November 2007 to January 2009 in its initial Cohort I. One year follow-up data was obtained on 98 percent of studied patients. Thomas also announced that 30-day results on an additional cohort of 1,301 patients (Cohort 2) enrolled in 2009 will be reported in the fall.

"The SOURCE Registry is unprecedented in its rigor as a commercial registry, which is critical for our understanding of the developing therapy of transcatheter aortic valve implantation. The one-year outcomes continue to demonstrate that European clinical teams are translating early clinical learnings into successful therapy in an appropriate patient population," said Olaf Wendler, M.D., Ph.D., clinical director for cardiology and cardiothoracic surgery, King's College Hospital in London.

Thomas and Wendler provide paid consulting services to Edwards for education, and research and development of transcatheter valve technologies.

For more information: www.edwards.com

Related Content

A key slide from Elnabawi's presentation, showing cardiac CT plaque evaluations, showing the impact of psoriasis medication on coronary plaques at baseline and one year of treatment. It shows a reversal of vulnerable plaque development. #SCAI, #SCAI2018

A key slide from Elnabawi's presentation, showing cardiac CT plaque evaluations, showing the impact of psoriasis medication on coronary plaques at baseline and one year of treatment. It shows a reversal of vulnerable plaque development.  

Feature | Cardiovascular Clinical Studies | May 14, 2018
May 14, 2018 – New clinical evidance shows common therapy options for psoriasis (PSO), a chronic inflammatory skin di
Intravenous Drug Use is Causing Rise in Heart Valve Infections, Healthcare Costs. #SCAI, #SCAI2018
News | Cardiovascular Clinical Studies | May 14, 2018
May 14, 2018 — The opioid drug epidemic is impacting cardiology, with a new study finding the number of patients hosp
Patient Enrollment Completed in U.S. IDE Study of THERMOCOOL SMARTTOUCH SF Catheter
News | Cardiovascular Clinical Studies | March 15, 2018
March 15, 2018 –  Johnson & Johnson Medical Devices Companies announced today that Biosense Webster, Inc., who wo
Lexington Begins HeartSentry Clinical Trial
News | Cardiovascular Clinical Studies | February 20, 2018
February 20, 2018 – Lexington Biosciences, Inc., a development-stage medical device company, announced the commenceme
Endologix Completes Patient Enrollment in the ELEVATE IDE Clinical Study
News | Cardiovascular Clinical Studies | February 06, 2018
February 6, 2018 – Endologix, a developer and marketer of treatments for aortic disorders, announced the completion o
12-Month Results from Veryan Medical's MIMICS-2 IDE Study Presented at LINC
News | Cardiovascular Clinical Studies | February 01, 2018
February 1, 2018 – Thomas Zeller (Bad Krozingen, Germany) presented the 12-month results from Veryan Medical’s MIMICS
LimFlow Completes U.S. Feasibility Study Enrollment, Receives FDA Device Status
News | Cardiovascular Clinical Studies | February 01, 2018
February 1, 2018 –  LimFlow SA, developer of minimally-inv
ESC 2017 late breaking trial hot line study presentations.
News | Cardiovascular Clinical Studies | September 12, 2017
September 12, 2017 – The European Society of Cardiology (ESC) Congress 2017 includes several Hot Line Late-breaking C
U.K., NHS studies, weekend effect, hospital admission, atrial fibrillation, heart failure
News | Cardiovascular Clinical Studies | June 28, 2016
New research shows patients admitted to National Health Service (NHS) hospitals in the United Kingdom for atrial...
stroke risk
News | Cardiovascular Clinical Studies | August 28, 2015
Most people assume strokes only happen to octogenarians, but recent evidence suggests that survivors of childhood can
Overlay Init