Tag: replacement heart valve

Categories : Cardiovascular Disease Surgeries & ProceduresTags :

Trial Finds Similar Outcomes for TAVR and Surgery

On By ModernMedia

Phase III clinical trial by Cedars-Sinai and other institutions shows no significant differences for mortality, stroke or rehospitalisation at seven years post-treatment

Artificial heart valve. Credit: Scientific Animations CC4.0

People who underwent TAVR, a minimally invasive procedure to have their heart’s aortic valve replaced had similar health outcomes years after treatment as people who had surgery, Cedars-Sinai investigators and colleagues report.

Raj Makkar, MD, an interventional cardiologist in the Department of Cardiology in the Smidt Heart Institute, is senior author of a study published in The New England Journal of Medicine that describes the Phase III clinical trial results.

“These results show that seven years after treatment, health outcomes for patients were similar whether they underwent a minimally invasive procedure or open-heart surgery,” said Makkar.

Aortic valve disease affects about 2% of the US population, and risk rises with age, so the disorder is expected to become increasingly common.

The international PARTNER 3 trial involved 1000 patients at 71 healthcare locations. Study participants had a severe form of aortic valve stenosis, a condition in which the heart’s aortic valve becomes so narrow and stiff that it cannot open fully to allow blood to pass through. The condition can cause heart failure or stroke.

Clinical trial participants were randomly chosen to undergo either open-heart surgery or a procedure called a transcatheter aortic valve replacement, also known as TAVR. All participants received a commercially available bioprosthetic valve called the SAPIEN 3 valve.

During TAVR, an interventional cardiologist threads a catheter through an artery to reach the heart and replace the diseased valve. Previous randomised controlled trials, including an earlier version of PARTNER 3, reported similar outcomes with TAVR and surgery five years after treatment in people with low to high risk for surgical complications.

For this study, investigators limited participation to patients considered to be at low surgical risk. Seven years after treatment, composite rates of death, stroke or rehospitalisation related to treatment were 34.6% for TAVR (496 people) and 37.2% for surgery (454 people), a difference that was not statistically significant. The rates of failure for the bioprosthetic valve were similar: 6.9% for TAVR and 7.3% for surgery. In addition, patients in both groups reported comparable quality of life outcomes.

“These rich data exemplify the vital information clinicians need to guide patient treatment,” said Eduardo Marbán, MD, PhD, executive director of the Smidt Heart Institute and the Mark Siegel Family Foundation Distinguished Chair. “We are proud to offer leading-edge clinical care while also advancing the field of cardiology with groundbreaking research.”

The Smidt Heart Institute is a global leader in treating heart valve disease surgically and with transcatheter procedures. Makkar, vice president of Cardiovascular Innovation and Intervention, leads a team of interventional cardiologists who perform almost 800 TAVRs each year.

The investigators next plan to report patient outcomes and valve durability at 10 years posttreatment.

Source: Cedars-Sinai

Categories : Cardiovascular Disease Implants and Prostheses PaediatricsTags :

Heart Valve Which ‘Grows’ with Young Children Undergoing Preclinical Testing

On By ModernMedia
The Iris Valve, a transcatheter, growth-accommodating pulmonary valve designed for very young children, was developed at UC Irvine and is currently progressing toward FDA clinical approval. Arash Kheradvar

Researchers at the University of California, Irvine have successfully performed preclinical laboratory testing of a replacement heart valve intended for toddlers and young children with congenital cardiac defects, a key step toward obtaining approval for human use. The results of their study were published recently in the Journal of the American Heart Association.

The management of patients with congenital heart disease who require surgical pulmonary valve replacement typically occurs between the ages of 2 and 10. To be eligible for a minimally invasive transcatheter pulmonary valve procedure, patients currently must weigh at least 20.4kg. For children to receive minimally invasive treatment, they must be large enough so that their veins can accommodate the size of a crimped replacement valve. The Iris Valve designed and developed by the UC Irvine team can be implanted in children weighing as little as 7.7 to 10kg and gradually expanded to an adult diameter as they grow.

Research and development of the Iris Valve has been supported by the Eunice Kennedy Shriver National Institute of Child Health and Human Development; the National Heart, Lung, and Blood Institute; and the National Science Foundation.

This funding has enabled benchtop fracture testing, which demonstrated the valve’s ability to be crimped down to a 3mm diameter for transcatheter delivery and subsequently enlarged to 20mm without damage, as well as six-month animal studies that confirmed successful device integration within the pulmonary valve annulus, showing valve integrity and a favourable tissue response.

“We are pleased to see the Iris Valve performing as we expected in laboratory bench tests and as implants in Yucatan mini pigs, a crucial measure of the device’s feasibility,” said lead author Arash Kheradvar, UC Irvine professor of biomedical engineering. “This work represents the result of longstanding collaboration between our team at UC Irvine and Dr Michael Recto at Children’s Hospital of Orange County built over several years of joint research and development.”

Congenital heart defects affect about 1% of children born in the United States and Europe, with over 1 million cases in the US alone. These conditions often necessitate surgical interventions early in life, with additional procedures required to address a leaky pulmonary valve and prevent right ventricular failure as children grow.

The Iris Valve can be implanted via a minimally invasive catheter through the patient’s femoral vein. The Kheradvar group employed origami folding techniques to compress the device into a 12-French transcatheter system, reducing its diameter to no more than 3mm. Over time, the valve can be balloon-expanded up to its full 20mm diameter.

This implantation method, along with the ability to begin treatment earlier in very young patients, helps mitigate the risk of complications from delayed care and reduces the need for multiple surgeries in this vulnerable population.

“Once the Iris Valve comes to fruition, it will save hundreds of children at least one operation – if not two – throughout the course of their lives,” said Recto, an interventional paediatric cardiologist at CHOC who’s also a clinical professor of paediatrics at UC Irvine. “It will save them from having to undergo surgical pulmonary valve placement, as the Iris Valve is delivered via a small catheter in the vein and can be serially dilated to an adult diameter and also facilitate the future placement of larger transcatheter pulmonary valves – with sizes greater than 20 millimetres, like the Melody, Harmony and Sapien devices – if needed.”

Source: University of California, Irvine