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

SAPIEN valve, surgery equivalent at 5-years

Patients for new valve-replacement technology will be followed for life in registry

2015-03-16
(Press-News.org) SAN DIEGO (March 15, 2015) -- Five-year data suggest that the SAPIEN transcatheter heart valve is a feasible option for patients with severe aortic stenosis deemed to be at high risk for open-heart surgery, though valve leakage was more common with the first-generation valve evaluated in this study than with surgery, according to research from PARTNER I presented at the American College of Cardiology's 64th Annual Scientific Session.

When the blockage of an aortic valve becomes severe, replacement is the only real treatment choice, but many elderly and frail people are poor candidates for open-heart surgery to place a new valve. The PARTNER I trial randomly assigned 699 high-risk patients to valve replacement with standard surgery or transcatheter aortic valve replacement, known as TAVR, a less invasive procedure featuring a tiny metal frame containing a cow tissue valve, which is expanded by a balloon after placement in the target valve.

"The surprise is that there were no surprises," said Michael Mack, M.D., chief of cardiovascular disease at Baylor Scott and White Health in Dallas. "The findings at five years confirm the earlier findings that outcomes are equivalent in high-risk surgical patients with surgery and with TAVR." There were no signs of structural valve deterioration or loss of valve function with TAVR, he said.

The FDA has approved the SAPIEN valve for inoperable and high-risk operable patients.

At five years, death and stroke rates were statistically the same in both groups: 67.8 percent of TAVR patients and 62.4 percent of surgery patients had died, with median survival of 44.5 months with TAVR and 40.6 months with surgery. Stroke rates were 15.9 percent for TAVR patients and 14.7 percent for surgery patients. Rehospitalization rates and functional outcomes also were the same in both groups.

Transcatheter valves have not approached the low leakage rate around the valve that can be achieved by an open-heart operation. As in previous findings, the rate of moderate or severe leaking around the valve remained significantly higher for the TAVR group--14 percent with TAVR and 2.1 percent with surgery--and at five years, that higher leakage rate still led to an increase in deaths with the death rate in patients with leakage 9 percent greater than in patients who didn't have a significant leak. The first-generation valve used in this trial has already been replaced by a second-generation device that is approved in the United States, and a third-generation valve has been designed specifically to reduce leakage. Thirty-day results for the third-generation valve will be reported separately at the ACC meeting.

Data analysis identified several indications and cautions for both procedures. Kidney disease was a significant issue with TAVR but not surgery; a high Society of Thoracic Surgeons risk score, which indicates the patient is sicker at the time of treatment, was a predictor of death in the surgery group; and liver disease was a significant factor in both groups. TAVR patients will be followed annually for life in the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapies registry; surgery patients will not be followed beyond five years.

"You can look at this trial and say, 'there's no difference in the two arms, what's the big deal?,' but that's the major message," Mack said. "With a brand-new therapy using a first-generation device that represents most of the experience of the clinical trial sites, outcomes were virtually identical to the standard of care for the last 50 years."

INFORMATION:

Edwards Lifesciences funded the trial and pays Mack's travel expenses for meetings of its executive committee, of which he is a member. He receives no other compensation from the company.

This study was simultaneously published online in the Lancet at the time of presentation.

Special note: Michael Davidson, a surgeon from Boston and one of the original investigators of this trial, was killed in January at the age of 44 by the son of a former patient. The PARTNER trial team dedicates this presentation and journal paper to his memory.

The ACC's Annual Scientific Session brings together cardiologists and cardiovascular specialists from around the world each year to share the newest discoveries in treatment and prevention. Follow @ACCMediaCenter and #ACC15 for the latest news from the meeting.

The American College of Cardiology is a 49,000-member medical society that is the professional home for the entire cardiovascular care team. The mission of the College is to transform cardiovascular care and to improve heart health. The ACC leads in the formation of health policy, standards and guidelines. The College operates national registries to measure and improve care, provides professional medical education, disseminates cardiovascular research and bestows credentials upon cardiovascular specialists who meet stringent qualifications. For more information, visit acc.org.



ELSE PRESS RELEASES FROM THIS DATE:

Self-expanding TAVR widens advantage over surgery at 2 years

2015-03-16
SAN DIEGO (March 15, 2015) -- Two-year data show a continued survival advantage for self-expanding transcatheter aortic valve replacement (TAVR) over standard surgery in high-risk patients with severe aortic stenosis, according to research presented at the American College of Cardiology's 64th Annual Scientific Session. Aortic stenosis--a problem that occurs when the valve in the heart's main artery doesn't open fully--forces the heart to work harder to pump blood and is life-threatening over time. Valve replacement is common when this condition becomes severe, but the ...

MitraClip valve repair continues to show benefit in commercial setting

2015-03-16
SAN DIEGO (March 15, 2015) --The commercial track record with transcatheter mitral valve repair, approved for patients at high risk for surgery, compares favorably with pre-approval reports, according to findings from a U.S. registry presented at the American College of Cardiology's 64th Annual Scientific Session. Healthy valves function as one-way gates that keep blood moving forward through the heart. Severely damaged mitral valves don't close properly, allowing blood to leak backward. If the valve isn't repaired or replaced, the condition can cause serious health ...

Police not prepared for death investigations

2015-03-16
Police are ill-equipped to investigate non-criminal deaths and face a challenge to avoid re-traumatising bereaved families as well as emotionally protecting themselves, according to QUT research. Investigating death: the emotional and cultural challenges for police found it was usually junior officers sent to sudden death investigations and tasked with not only gathering evidence, but also comforting family members and explaining the coronial process. The research has been published in the journal of Policing and Society. "The vast majority of deaths are neither ...

Risk patterns identified that make people more vulnerable to PTSD

2015-03-16
NEW YORK, NY - Researchers have built a new computational tool that identifies 800 different ways people are at increased risk for post-traumatic stress disorder (PTSD), permitting for the first time a personalized prediction guide. Results from the study out of NYU Langone Medical Center are published online (date) in the journal BMC Psychiatry. "Our study shows that high-risk individuals who have experienced a traumatic event can be identified less than two weeks after they are first seen in the emergency department," says Arieh Y. Shalev, MD, the Barbara Wilson ...

Survey finds doctors want to learn more about diet and cardiovascular disease prevention

2015-03-16
NEW YORK, March 15, 2015 - Most physicians are aware of the importance of lifestyle factors in preventing cardiovascular disease (CVD) -- and believe diet is as important as statin therapy and exercise, according to a new survey from NYU Langone Medical Center. Researchers found that a majority of doctors would welcome additional training in diet and nutrition so that they can effectively inform patients on the subject. The study will be presented at the American College of Cardiology's 64th Annual Scientific Session as a poster presentation. The 28-question online survey, ...

Pollution levels linked to stroke-related narrowing of arteries

2015-03-16
NEW YORK, March 4, 2015 - Air pollution has been linked to a dangerous narrowing of neck arteries that occurs prior to strokes, according to researchers at NYU Langone Medical Center. The scientists analyzed medical test records for more than 300,000 people living in New York, New Jersey or Connecticut. They found that people living in zip codes with the highest average levels of fine-particulate-matter pollution were significantly more likely to show signs of narrowing (stenosis) in their internal carotid arteries, compared to those living in zip codes with the lowest ...

Dialing a bespoke signal

2015-03-16
March 16, 2015, New York, NY - Exploring the fundamental mechanism by which a cell-surface receptor transmits its signal, an international team of Ludwig researchers and their colleagues has established proof of concept for an entirely new approach to drug design. They report that a class of synthetic molecules known as diabodies can, from outside the cell, latch onto a target receptor and manipulate it in such a manner as to induce distinct and varying effects within cells and tissues. Led by Christopher Garcia of Ludwig Stanford, the researchers show in lab experiments ...

Development of a carnivorous pitcher leaf

Development of a carnivorous pitcher leaf
2015-03-16
Carnivorous plants have strange-shaped leaves, and they can grow on nutrient-poor environments by trapping and eating small animals. Charles Darwin, often called "the father of evolution", was also interested in carnivorous plants, and he wrote a book titled "Insectivorous Plants" published in 1875. Since then a lot of researches have been done, but how such strange-shaped leaves were altered during evolution remained unknown. A research team in Japan has revealed how carnivorous pitcher leaves are formed in Sarracenia purpurea, a carnivorous plant native to North America. ...

Biodiversity-protected areas in Indonesia ineffective in preventing deforestation: NUS-led study

2015-03-16
Establishing protected areas in forests is one way to keep deforestation at bay and safeguard biodiversity. However, a study led by researchers from the National University of Singapore (NUS) has revealed that such a measure is ineffective in the case of biodiversity-focused protected areas in Indonesia. The research, led by Assistant Professor Roman Carrasco of the Department of Biological Sciences at the NUS Faculty of Science and Assistant Professor Alex Cook of NUS' Saw Swee Hock School of Public Health, found that the monitoring and prevention of road construction ...

High-dose zinc acetate lozenges may help shorten symptoms associated with the common cold

2015-03-16
According to a meta-analysis published in BMC Family Practice, high dose zinc acetate lozenges may help shorten diverse symptoms associated with the common cold. The common cold is an infection caused by over a hundred viruses, and it is a major cause of days off school or work and visits to a doctor. A previous meta-analysis of three randomized trials found that high dose zinc acetate lozenges shorten the duration of colds by 42%. Since all of the three studies reported the duration of diverse respiratory symptoms and of systemic symptoms such as muscle ache and headache, ...

LAST 30 PRESS RELEASES:

Pink skies

Monkeys are world’s best yodellers - new research

Key differences between visual- and memory-led Alzheimer’s discovered

% weight loss targets in obesity management – is this the wrong objective?

An app can change how you see yourself at work

NYC speed cameras take six months to change driver behavior, effects vary by neighborhood, new study reveals

New research shows that propaganda is on the rise in China

Even the richest Americans face shorter lifespans than their European counterparts, study finds

Novel genes linked to rare childhood diarrhea

New computer model reveals how Bronze Age Scandinavians could have crossed the sea

Novel point-of-care technology delivers accurate HIV results in minutes

Researchers reveal key brain differences to explain why Ritalin helps improve focus in some more than others

Study finds nearly five-fold increase in hospitalizations for common cause of stroke

Study reveals how alcohol abuse damages cognition

Medicinal cannabis is linked to long-term benefits in health-related quality of life

Microplastics detected in cat placentas and fetuses during early pregnancy

Ancient amphibians as big as alligators died in mass mortality event in Triassic Wyoming

Scientists uncover the first clear evidence of air sacs in the fossilized bones of alvarezsaurian dinosaurs: the "hollow bones" which help modern day birds to fly

Alcohol makes male flies sexy

TB patients globally often incur "catastrophic costs" of up to $11,329 USD, despite many countries offering free treatment, with predominant drivers of cost being hospitalization and loss of income

Study links teen girls’ screen time to sleep disruptions and depression

Scientists unveil starfish-inspired wearable tech for heart monitoring

Footprints reveal prehistoric Scottish lagoons were stomping grounds for giant Jurassic dinosaurs

AI effectively predicts dementia risk in American Indian/Alaska Native elders

First guideline on newborn screening for cystic fibrosis calls for changes in practice to improve outcomes

Existing international law can help secure peace and security in outer space, study shows

Pinning down the process of West Nile virus transmission

UTA-backed research tackles health challenges across ages

In pancreatic cancer, a race against time

Targeting FGFR2 may prevent or delay some KRAS-mutated pancreatic cancers

[Press-News.org] SAPIEN valve, surgery equivalent at 5-years
Patients for new valve-replacement technology will be followed for life in registry