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New Pulmonary Valve Benefits Quality, Length Of Life
New pulmonary valve benefits quality, length of lifePR Newswire
PEORIA, Ill., Aug. 8, 2023
PEORIA, Ill., Aug. 8, 2023 /PRNewswire/ -- Nearly 500,000 people undergo open-heart surgery a year in the United States. New technology being used by OSF HealthCare is hoping to bring that number down.
Starting this year, OSF began offering the Alterra Pre Stent to patients in Peoria. The FDA-approved valve consists of a catheter-based stent (called Alterra), an artificial heart valve (SAPIEN 3) and the opportunity to implant the stent and valve without the need for open-heart surgery.
Priti Patel, MD, is the director of the Pediatric and Congenital Cardiac Catheterization Laboratory for OSF HealthCare. She says this new technology will expand peoples' lives and enhance their quality of life.
"The advantage of the procedure is that the patient is up and awake, walking around after six hours. They get to go home the next day," Dr. Patel says. "With open-heart surgery, they are in the hospital for a longer period of time, and they have to recover from the sternotomy. Here, there is no recovery. There are no stitches in the groin, and they are going back to school or work the following day."
The abovementioned sternotomy is a procedure where a surgical incision is made through the breastbone (sternum) to access the thoracic cavity for open-heart surgery.
"The goal is to prevent repeated open-heart surgeries. The more sternotomies and open-heart surgeries they have, the more risk they have each time. With this, you can prevent that from happening," Dr. Patel adds. "You can do the procedure and see the results right away. The patients feel good when they wake up, because it is easy to breathe."
Dr. Patel says the new pulmonary valve is supposed to last 10 years. This current pulmonary valve that is in place allows you to be ready for another less-invasive procedure when the time comes.
"Now when it's needed, you can put multiple valves inside it. So, you can get these 40-50 years out without needing any open-heart surgeries," Dr. Patel says.
Dr. Patel and her team administered four pulmonary valves in patients this spring, with two more procedures planned in August. These procedures happen at the OSF HealthCare Children's Hospital of Illinois Congenital Heart Center located at OSF HealthCare Saint Francis Medical Center. Dr. Patel says these patients come from all across the State of Illinois and can continue their health journey with their care team at OSF. They can perform the procedures on people of all ages.
Additional assets including video, audio clips, and photos are available on the OSF Newsroom.
OSF HealthCare is an integrated health system owned and operated by The Sisters of the Third Order of St. Francis, headquartered in Peoria, Illinois. OSF HealthCare has 15 hospitals – 10 acute care, five critical access - with 2,084 licensed beds throughout Illinois and Michigan. OSF employs nearly 24,000 Mission Partners throughout 150+ locations; has two colleges of nursing; operates OSF Home Care Services, an extensive network of home health and hospice services; owns Pointcore, Inc., comprised of health care-related businesses; OSF HealthCare Foundation, the philanthropic arm for the organization; and OSF Ventures, which provides investment capital for promising health care innovation startups. OSF OnCall, a digital health operating unit, was established in 2020 to improve patient experience, using digital tools for 24-7 communication, on-demand care, remote patient monitoring, and offers the largest hospital-at-home program in Illinois. OSF HealthCare has been recognized by Fortune as one of the most innovative companies in the country. More at osfhealthcare.Org.
Contact: Matt Sheehan, Media Relations Coordinator, OSF HealthCare(309) 308-5015
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SOURCE OSF HealthCare
$2M Grant To Speed PolyVascular's Pediatric Catheter-Delivered Pulmonary Valve Replacement To Market
The NIH/NCT 2-year Phase II SBIR (Small Business Innovation Research) grant awarded $2 million to PolyVascular, propelling the company into its next steps: developing valves of several sizes (XS to XL, or adult), benchtop testing, and GLP animal research to verify functionality, culminating in potential discussion with FDA for an early feasibility study. The SBIR funding, which comes on the heels of Phase I funding, will move the company's valve development from academic research toward manufacturing.
The global market for transcatheter pulmonary valves was valued at more than $31 million in 2015, according to Grandview Research, however that estimate includes adult patients. Within the market, pediatric device share is expected to grow as catheter-delivered devices continue to proliferate across the entire cardiac device space.
In March, Medtronic received FDA breakthrough device designation for its Harmony Transcatheter Pulmonary Valve System for pulmonary valve regurgitation in congenital heart disease patients. The device can be placed via catheter and was approved for adult and pediatric patients. Edwards Sapien XT also delivers a valve replacement device through catheter. Both devices use animal tissue within a metal frame.
Poor valve longevity and availabilityPolyVascular identified the pediatric heart valve space based on ongoing unmet needs in the space. Pediatric patients with dysfunctional pulmonary valves often have limited options, and are likely to undergo multiple open-heart surgeries throughout their lives. One major hurdle in pediatrics is that not all adult heart valve technologies translate.
Bioprosthetic valves don't often miniaturize well, according to Henri Justino, MD, interventional cardiologist, CMO, and co-founder at PolyVascular. Bioprosthetic valves are typically made from hand sewing animal tissue onto frames, he said: "It's challenging to get [bioprosthetic] valves to work really well if you make them at really small sizes. Then the leaflets just don't open or close well, their properties aren't very good, and they probably wouldn't last very long either."
Due to these limitations, most pediatric patients receive donated, or cadaveric valves. But because these are human foreign tissue, the body quickly begins to attack and break down the devices. Some valves last as short as a few months while others may last around 5 years, according to Justino. "We are stuck in this challenging problem for kids because the valves we have for them don't last very long. These homograft valves are overall quite poor," he said. The average cadaveric valve longevity is about 1 to 2 years.
"I sometimes wonder if [cadaveric valves] would even be FDA-approved now if this was the first time they were being presented before FDA because they last so poorly," said Justino.
On top of the potentially short-lived utility, homograft valves are also in short supply. "The fact that [pediatric cadaveric pulmonary valves] are made from children who have passed away and donated their valves also makes them poorly available. There are very few – fortunately – children who die and give up their valves." Because the donated valves are few, patients will use an available valve despite ill fit; the valve a patient receives might not be an exact size match.
The lack of replacement valve availability – and desire to minimize the number of surgeries – also means that patients may need to wait longer than recommended for a valve replacement. A child may be expected to make do with a leaky, poorly functioning valve that is stretched to accommodate growth, but not replaced until the heart begins to decompensate.
"We have developed a culture and a need to limp patients along with valves that don't not work well for many may years to avoid another replacement," said Justino. "That's not the way we want to go but that's the reality of a replacement when it's quite invasive via open-heart surgery, most people try to avoid it as long as they can."
Polymer approach through grant fundingPolyVascular plans to address the market gaps in pediatric pulmonary valves with a polymer-based device that is placed through catheterization, and can be adjusted as a patient grows. The first polymer-based pulmonary valve, the leaflet material was chosen to allow for miniaturization without compromising functionality.
Medical grade polymers allow PolyVascular to create small very small valves that still function well. "We can make valves that are incredibly thin and delicate. They can operate very well even at small diameters which would not be true of valves that are made of animal tissues that are handsewn. They would be too bulky, too thick and it wouldn't work well." Using polymers also reduces the cost of valves, making them accessible to more patients, including in developing countries.
PolyVascular's work thus far has been backed by undiluted funding, with about $3 million through philanthropic and grant resources. The move was a strategic de-risking as the pediatric device market is relatively small. Pediatric congenital heart disease is estimated to impact about 1 million patients globally, with the most common being pulmonary heart valve disease.
"When it's already hard for people to invest in a pediatric device, if you come to them with an idea on the back of a napkin and say, 'Wouldn't it be good if we did this and they just see an enormous amount of work ahead to get from the idea on a napkin to an actual device, it's discouraging. It takes a lot of money, and time and effort and most companies won't tackle those unmet needs unless they see a huge return on investment." By tackling a lot of the up-front work in R&D without investment, future funding would help the company to address the latter steps in bringing a device to market.
Ask The Experts: Living With Emphysema And Things To Know
MUNCIE, Ind. – What is emphysema?
In simple terms, emphysema is a condition that results in breathlessness and can make it difficult to breathe. It occurs when the air sacs in the lungs, or the alveoli, is damaged. Over time, the lung tissue will rupture and eventually create one large air pocket instead of the standard small ones. The damaged lung will trap air making it difficult to exhale. Emphysema is a chronic obstructive pulmonary disorder often referred to as COPD and is very common in the United States.
Natasha Dudiki, MD is a Pulmonary and Critical Care Medicine provider at IU Health Ball.
How do I know if I have emphysema?Because emphysema damages the lungs, it can result in difficulty of breath. Some common symptoms include a shortness of breath, coughing often with phlegm, wheezing and chest pain. The condition occurs gradually and can take years to notice. If you think you may have it, there are a couple different tests that can be done to make an official diagnosis. These include chest X-rays, pulse oximetry, pulmonary function tests, arterial blood gas tests and electrocardiogram (ECG).
How can I prevent emphysema?Research has shown that emphysema is strongly linked to smoking. To avoid a high risk of contracting emphysema, stay away from smoking, vaping and other devices that bring unnecessary inhalants into the lungs. If possible, avoid air pollutants which can also damage the lung tissue.
If an alpha-1 antitrypsin deficiency or other respiratory infections run in your family or have had issues in the past, reach out to your primary care physician if you start to notice an increase in breathlessness.
What are treatment options?No one treatment will fix the condition, but there are many treatment options available to help those living with symptoms of emphysema.
Bronchodilator medications: If you experience tightness in your chest, these medications, which are usually given as inhalers, can help relax your airway muscles and widen the airways. These medications are common for people with asthma and COPD.
Anti-inflammatory medication: These medications can reduce airway inflammation. These are recommended for COPD patients who notice a large amount of mucus and swelling in the airways.
Pulmonary rehab: A comprehensive respiratory program that focuses on pulmonary rehabilitation using individualized and supervised exercise prescription, which has been shown slowing disease progression and improve overall health status.
Minimally invasive procedure with valves: Recommended for patients with shortness of breath despite maximal medical therapy.
Oxygen therapy: If medications aren't helping, supplemental oxygen can be prescribed if your doctor notes your oxygen levels to be low.
Emphysema causes damage in the lungs that limits air flow. By adding more oxygen to the body, the air can flow slightly better and move through the bloodstream. There are a few different options to supply additional oxygen.
A nasal cannula is a device with two small tubes that fit in your nostrils and a longer air tube attached to an oxygen tank. This is the most common oxygen therapy device, and likely the first one you envision. If the tubes are not working or you need significantly more oxygen, you can try a facemask. These cover the nose and mouth to keep a more constant and present level of oxygen.
Regardless of the oxygen therapy you choose, oxygen tanks will accompany your device. They can be small enough to move around with you, or you can find larger ones for home use.
How will life change if I develop emphysema?The condition is a progressive disease, so it will take a gradual time for it to worsen. In the beginning, you may not notice much of a difference. A decrease in activity can occur as it becomes increasingly difficult to breathe.
When living with an oxygen tank, options for travel become limited. It is recommended to stay at least five feet away from open flames. This includes cooking with gas. It can be dangerous to smoke or be near a smoker as this can create contaminated air quality.
Natasha Dudiki, MD is a Pulmonary and Critical Care Medicine provider at IU Health Ball – Muncie. Learn more at iuhealth.Org/find-medical-services/emphysema.
This article originally appeared on Lafayette Journal & Courier: Ask the Experts: Living with emphysema and things to know
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