PRESS-NEWS.org - Press Release Distribution
PRESS RELEASES DISTRIBUTION

Results of the REPRISE II trial reported at TCT 2013

Second generation transcatheter aortic valve shown to successfully address complications of TAVR

2013-11-01
(Press-News.org) Contact information: Judy Romero
jromero@crf.org
Cardiovascular Research Foundation
Results of the REPRISE II trial reported at TCT 2013 Second generation transcatheter aortic valve shown to successfully address complications of TAVR SAN FRANCISCO, CA – THURSDAY OCTOBER 31, 2013 – In a clinical trial, a second-generation transcatheter aortic valve demonstrated low rates of complications that are sometimes seen in transcatheter aortic valve replacement (TAVR), including challenges with positioning, post-procedure paravalvular aortic regurgitation, vascular complications, and stroke.

The findings were presented today at the 25th annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium. Sponsored by the Cardiovascular Research Foundation (CRF), TCT is the world's premier educational meeting specializing in interventional cardiovascular medicine.

The valve studied in REPRISE II is fully retrievable and repositionable with a unique adaptive seal intended to minimize paravalvular regurgitation, a complication that has been associated with higher mortality among patients undergoing TAVR. In this prospective, single arm, multicenter study, symptomatic patients at high risk for surgery received the Lotus valve to treat calcific aortic stenosis.

The trial enrolled 120 patients; mean age was 84.4±5.3 years, 56.7 percent were female, and 75.8 percent were considered New York Heart Association (NYHA) Class III or IV. The mean Society of Thoracic Surgeons score was 7.1±4.6 percent and all patients were confirmed by their site heart team to be at high risk for surgery due to frailty or associated comorbidities.

The valve was successfully implanted in all 120 patients with valve repositioning and retrieval performed as needed. There was no embolization, ectopic valve deployment, or need for implantation of a second prosthetic valve.

The primary device performance endpoint was the mean aortic valve pressure gradient at 30 days compared to a performance goal of 18 mmHg; the primary safety endpoint was 30-day mortality. The primary device performance endpoint was met with a 30 day mean aortic valve pressure gradient of 11.5±5.2 mmHg; mean effective orifice area was 1.7±0.4 cm2. All cause mortality and disabling stroke were low at 30 days (4.2 percent and 1.7 percent, respectively). Additional clinical event rates were consistent with those reported for other valves. Aortic regurgitation at 30 days was negligible in 99.0 percent of patients (78.3 percent none, 5.2 percent trace, and 15.5 percent mild).

"These findings suggest this valve, which is a differentiated, second generation TAVR device, will be a valuable addition for the treatment of severe aortic stenosis," said the lead investigator, Ian T. Meredith, MBBS, PhD. Dr. Meredith is Director of Monash HEART and the Executive Director of the Monash Cardiovascular Research Centre. He is also a Professor of Medicine at Monash University in Melbourne, Australia.

### The REPRISE II trial was funded by Boston Scientific. Dr. Meredith reported consultant fee/honoraria/speaker's bureau from Boston Scientific and Medtronic.

About CRF and TCT The Cardiovascular Research Foundation (CRF) is an independent, academically focused nonprofit organization dedicated to improving the survival and quality of life for people with cardiovascular disease through research and education. Since its inception in 1991, CRF has played a major role in realizing dramatic improvements in the lives of countless numbers of patients by establishing the safe use of new technologies and therapies in interventional cardiovascular medicine. CRF is the sponsor of the Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium. Celebrating its 25th anniversary this year, TCT is the world's premier educational meeting specializing in interventional cardiovascular medicine. For more information, visit http://www.crf.org and http://www.tctconference.com.


ELSE PRESS RELEASES FROM THIS DATE:

Experimental drug shows encouraging results in treating most common form of lung cancer

2013-11-01
Experimental drug shows encouraging results in treating most common form of lung cancer An experimental cancer drug that has shown promise in the treatment of melanoma has also shown early potential as an effective treatment for patients with non-small ...

Oligomeric proanthocyanidin suppresses the death of retinal ganglion cells

2013-11-01
Oligomeric proanthocyanidin suppresses the death of retinal ganglion cells The death of retinal ganglion cells is a hallmark of many optic neurodegenerative diseases such as glaucoma and retinopathy. Oxidative stress is one of the major reasons to cause the ...

Can Aβ worsen cognitive impairment following cerebral ischemia-reperfusion injury?

2013-11-01
Can Aβ worsen cognitive impairment following cerebral ischemia-reperfusion injury? Amyloid β-peptide, a major component of senile plaques in Alzheimer's disease, has been impli-cated in neuronal cell death and cognitive impairment. Recently, studies ...

Low-frequency rTMS prevents chronic epileptic seizure

2013-11-01
Low-frequency rTMS prevents chronic epileptic seizure Although increasing evidence indicates that low-frequency repetitive transcranial magnetic stimulation (rTMS), an emerging technology for neural regulation, has antiepileptic effects, the mechanism remains unclear. ...

Exposure to cortisol-like medications before birth may contribute to emotional problems and brain changes

2013-11-01
Exposure to cortisol-like medications before birth may contribute to emotional problems and brain changes Reports new study in Biological Psychiatry Philadelphia, PA, October 31, 2013 – Neonatologists seem to perform miracles in the fight to support the survival of ...

JCI early table of contents for Nov. 1, 2013

2013-11-01
JCI early table of contents for Nov. 1, 2013 Liver tropism is key for B cell deletion immunotherapy Antibodies against the B cell surface protein CD20 have been used successfully to treat B cell-mediated autoimmune diseases and lymphomas. Antibody binding ...

Liver tropism is key for B cell deletion immunotherapy

2013-11-01
Liver tropism is key for B cell deletion immunotherapy Antibodies against the B cell surface protein CD20 have been used successfully to treat B cell-mediated autoimmune diseases and lymphomas. Antibody binding receptors, called Fc receptors, on other ...

Dysfunctional chemokine receptor promotes candidiasis

2013-11-01
Dysfunctional chemokine receptor promotes candidiasis Candida albicans is one of the leading causes of hospital-acquired infections in immune compromised patients. The risk of both developing candidiasis and the clinical outcome of infection is variable ...

Home visits lessen emergency care for infants

2013-11-01
Home visits lessen emergency care for infants Nurse home visits lead to dramatic savings in emergency care DURHAM, N.C. -- Home visits from a nurse are a proven, but expensive, way to help newborns get a good start in life. New research from Duke University suggests ...

New study: Rising temperatures challenge Salt Lake City's water supply

2013-11-01
New study: Rising temperatures challenge Salt Lake City's water supply In an example of the challenges water-strapped Western cities will face in a warming world, new research shows that every degree Fahrenheit of warming in the Salt Lake City region ...

LAST 30 PRESS RELEASES:

Salk scientist Joseph Ecker awarded McClintock Prize for Plant Genetics and Genome Studies

ADHD: Women are diagnosed five years later than men, despite symptoms appearing at the same age.

Power plants may emit more pollution during government shutdowns

Increasing pressures for conformity de-skilling and demotivating teachers, study warns

Researchers develop smarter menstrual product with potential for wearable health monitoring

Microwaves for energy-efficient chemical reactions

MXene current collectors could reduce size, improve recyclability of Li-ion batteries

Living near toxic sites linked to aggressive breast cancer

New discovery could open door to male birth control

Wirth elected Fellow of American Physical Society

The Journal of Nuclear Medicine Ahead-of-Print Tip Sheet: October 10, 2025

Destined to melt

Attitudes, not income, drive energy savings at home

The playbook for perfect polaritons

‘Disease in a dish’ study of progressive MS finds critical role for unusual type of brain cell

Solar-powered method lights the way to a ‘de-fossilized’ chemical industry

Screen time linked to lower academic achievement among Ontario elementary students

One-year outcomes after traumatic brain injury and early extracranial surgery in the TRACK-TBI Study

Enduring outcomes of COVID-19 work absences on the US labor market

Affirmative action repeal and racial and ethnic diversity in us medical school admissions

Cancer progression illuminated by new multi-omics tool

Screen time and standardized academic achievement tests in elementary school

GLP-1RA order fills and out-of-pocket costs by race, ethnicity, and indication

Study finds HEPA purifiers alone may not be enough to reduce viral exposure in schools

UVA Health developing way to ID people at risk of dangerous lung scarring even before symptoms appear

How can we know when curing cancer causes myocarditis?

Male infertility in Indian men linked to lifestyle choices and hormonal imbalances

An acoustofluidic device for sample preparation and detection of small extracellular vesicles

The advent of nanotechnology has ushered in a transformative era for oncology, offering unprecedented capabilities for targeted drug delivery and controlled release. This paradigm shift enhances thera

A prototype LED as thin as wallpaper — that glows like the sun

[Press-News.org] Results of the REPRISE II trial reported at TCT 2013
Second generation transcatheter aortic valve shown to successfully address complications of TAVR