News | October 31, 2013

St. Jude Medical Reports Positive Clinical Outcomes from Portico Heart Valve Study

trial study hybrid or heart valve repiar tct 2013 st. jude portico
October 31, 2013 — St. Jude Medical Inc. announced positive results for the 23 and 25mm Portico Transcatheter Aortic Heart Valves in the Portico Transfemoral CE mark trial (Portico TF CE Trial). Patients enrolled in the study experienced a significant improvement in valve function at 30 days. 
 
The preliminary findings indicate exceptional hemodynamic performance and improvement in the severity of heart failure symptoms as measured by the New York Heart Association (NYHA) functional classification system. The data was presented at the 25th Annual Transcatheter Cardiovascular Therapeutics scientific symposium (TCT 2013). 
 
Dr. Ganesh Manoharan, Royal Victoria Hospital, Belfast, United Kingdom and lead principal investigator, Portico TF CE Trial, presented preliminary data on the Portico 23 and 25mm valves from 83 patients diagnosed with severe aortic stenosis, a narrowing of the aortic valve that obstructs blood flow from the heart. These patients are candidates for a transcatheter aortic valve replacement (TAVR) procedure, as many are considered high-risk for conventional openheart valve replacement surgery.
 
Key findings at 30 days:
  • Improved hemodynamics, indicating a significant increase in valve function. Mean aortic valve pressure gradient was reduced from 45.6 mmHg to 8.7 mmHg
  • Post implant: 84.4 percent of patients were ranked NYHA class I or class II at 30 days, improved from 77.8 percent who were ranked NYHA class III or IV at baseline
  • Permanent pacemakers were implanted in 10.8 percent of patients to correct conduction complications that can occur following TAVR procedures
  • A very low rate of disabling or major stroke was reported in 2.4 percent and all-cause mortality was reported in 3.6 percent of patients
  • A low rate of vascular complications was reported in 6 percent of patients
Paravalvular (PV) leak was reported as follows:
  • PV leak defined as none-to-trivial was reported in 30 percent of patients
  • Mild PV leak was reported in 65 percent of patients
  • Moderate PV leak was reported in 5 percent of patients
  • There were no reports of severe PV leak
 
Additional study results reinforce safety and efficacy of the Portico valves beyond 30 days in the subset of patients that have completed longer-term follow up.
 
“The data presented today demonstrates the benefits of the Portico Transcatheter Aortic Heart Valve in treating sick and critically ill patients with symptomatic aortic stenosis, who simply cannot withstand the rigors of a surgical heart valve replacement procedure,” said Manoharan. “The Portico valve’s self-expanding stent design and ability to be repositioned prior to deployment helps ensure precise valve placement, potentially improving patient outcomes and reducing the likelihood of complications such as a post-procedural pacemaker.” 
 
The non-randomized, multi-center Portico TF CE Trial was initiated to evaluate the Portico 23 mm transcatheter heart valve, which received CE mark in November 2012 and was later expanded to include the Portico 25mm valve. Clinical results for the 25 mm Portico valve are currently under regulatory review to support European CE mark approval. 
 
The Portico valve is the first transcatheter aortic heart valve that can be completely resheathed, repositioned at the implant site or retrieved before being released from the delivery system. During transfemoral delivery, the Portico valve is implanted through a small incision in the femoral artery. The procedure uses a catheter to deliver and position the valve in the heart while it continues to beat. This avoids placing the patient on cardiopulmonary bypass, where a machine takes over heart and lung function during surgery. 
 
The Portico Transcatheter Aortic Heart Valve are not approved for use in the United States.
 
For more information: www.sjmportico.com
 

Related Content

Hershey's Chocolate display with samples and coco pods at the American College of Cardiology (ACC) 2012 annual meeting. The company was making the case that chocolate can be good for your heart, which is now supported by several studies. Photo by Dave Fornell

Hershey's Chocolate display with samples and coco pods at the American College of Cardiology (ACC) 2012 annual meeting. The company was making the case that chocolate can be good for your heart, which is now supported by several studies. Photo by Dave Fornell

News | Cardiovascular Clinical Studies | July 22, 2020
July 22, 2020 — Eating chocolate at least once a week is linked with a reduced risk of heart disease, according to re
The first 3-D images have been created of an RNA molecule known as "Braveheart" for its role in transforming stem cells into heart cells. Credit: Image courtesy Los Alamos National Laboratory

The first 3-D images have been created of an RNA molecule known as "Braveheart" for its role in transforming stem cells into heart cells. Credit: Image courtesy Los Alamos National Laboratory

News | Cardiovascular Clinical Studies | January 20, 2020
January 20, 2020 — Scientists at Los Alamos and international partners have created the first 3-D images of a special
Top Cardiology New in 2019 From the European Society of Cardioloigy (ESC)
News | Cardiovascular Clinical Studies | December 23, 2019
Environmental and lifestyle issues were popular this year, with pick up from both...
News | Cardiovascular Clinical Studies | November 26, 2019
November 26, 2019 — The University of Connecticut (UConn) Department of Kinesiology and Hartford Healthcare have sele
FDA Issues Final Guidance on Live Case Presentations During IDE Clinical Trials
News | Cardiovascular Clinical Studies | July 10, 2019
The U.S. Food and Drug Administration (FDA) issued the final guidance “Live Case Presentations During Investigational...
Veradigm Partners With American College of Cardiology on Next-generation Research Registries
News | Cardiovascular Clinical Studies | July 03, 2019
The American College of Cardiology (ACC) has partnered with Veradigm, an Allscripts business unit, to power the next...
New FDA Proposed Rule Alters Informed Consent for Clinical Studies
News | Cardiovascular Clinical Studies | November 19, 2018
The U.S. Food and Drug Administration (FDA) is proposing to add an exception to informed consent requirements for...
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