Pulmonary Valve Stenosis

TAMPA, Fla., Oct. 3, 2023 /PRNewswire/ -- The Patel Children's Heart Institute at St. Joseph's Children's Hospital achieved a milestone recently, implanting its 250th congenital transcatheter heart valve. "This accomplishment reflects the dedication of our entire congenital cardiac team," said Interventional Cardiologist Dr. Jeremy Ringewald, who is the director of the Cardiac Catheterization Laboratory at St. Joseph's Children's Hospital. "Most importantly, this means that we allowed 250 patients in need of pulmonary or tricuspid valve replacement to avoid open-heart surgery." Continue Reading "I could not be prouder of our entire cardiac team or happier for our patients," said Dr. Jeremy Ringewald. Tweet this Jennifer Carter, DNP, APRN, CPNP-AC; John Pino, recipient of the St. Joseph's Children's Hospital's 250th congenital transcatheter heart valve; and interventional cardiologist Dr. Jeremy Ringewald one day after Pino's cardiac procedure. Jennifer Carter, DNP, APRN, CPNP-AC, and Dr. Jeremy Ringewald, pediatric interventional cardiologist and medical director of the Cardiac Cath Lab at St. Joseph's Children's Hospital in Tampa, load a valve onto its delivery catheter as interventional cardiologist Dr. Jay Patel looks on. Tampa resident John Pino, 57, was the recipient of the 250th valve. He was born with pulmonary stenosis, a heart defect in which the pulmonary valve is narrowed and opens poorly. Pino underwent open-heart surgery when he was 9 years old to open up the narrowed valve, trading blockage for leakage. Eventually, the leakage led to enlargement of his heart and diminished exercise tolerance. "When it was determined that I would need to have my leaky pulmonary valve replaced, I was very happy to discover that Dr. Ringewald could do the repair without the need for another open-heart surgery," said Pino. During the procedure, Dr. Ringewald inserted the valve loaded on its delivery catheter into a vein in Pino's leg and guided the catheter by fluoroscopy to the location of his leaky pulmonary valve. The new valve was deployed inside the old valve and once released, it immediately began functioning. The team at St. Joseph's Children's Hospital has implanted the most transcatheter pulmonary valves in Florida since the program's inception and is one of the leading centers in the United States. "It's been a long, challenging and deeply gratifying odyssey for our congenital cardiac team and program. I could not be prouder of our cardiac crew or happier for our patients," said Dr. Ringewald. Pino's procedure was a success and instead of spending a week in the hospital, which is typical of most open-heart surgical procedures, he was discharged after just one day. "I'm so grateful to Dr. Ringewald and the entire heart team for taking such excellent care of me," said Pino. The Patel Children's Heart Institute at St. Joseph's Children's Hospital is home to the Tampa Bay area's only comprehensive congenital heart disease program. Its team of cardiac physicians perform hundreds of procedures each year to treat heart defects in patients of any age. A partnership between St. Joseph's Children's Hospital and UPMC Children's Hospital of Pittsburgh provides families across Florida with unprecedented access to the highest level of pediatric heart care available. Together, they provide highly specialized cardiovascular care for patients ranging from babies in the womb to adults with congenital heart disease. About St. Joseph's Children's Hospital St. Joseph's Children's Hospital is Tampa Bay's largest provider of children's health services and is committed to providing everything needed for the health and well-being of children. Together, BayCare Kids and St. Joseph's Children's Hospital offer specialized inpatient and outpatient pediatric care to thousands of children and their families each year in multiple locations throughout West Central Florida. From the tiniest baby to the high school quarterback, patients are cared for by doctors who specialize in treating children, in surroundings designed exclusively for kids. About BayCare BayCare is a leading not-for-profit health care system that connects individuals and families to a wide range of services at 16 hospitals and hundreds of other convenient locations throughout the Tampa Bay and central Florida regions. The system is West Central Florida's largest provider of behavioral health and pediatric services and its provider group, BayCare Medical Group, is one of the largest in the region. BayCare's diverse network of ambulatory services includes laboratories, imaging, surgical centers, BayCare Urgent Care locations, wellness centers and one of Florida's largest home care agencies, BayCare HomeCare. BayCare is ranked in the top 20% by Fortune/Merative. BayCare's mission is to improve the health of all it serves through community-owned, health care services that set the standard for high-quality, compassionate care. For more information, visit . SOURCE St. Joseph's Children's Hospital

Peca Labs , a medical device company making vascular grafts and valves with durable polymeric cardiovascular devices designed to fit, grow, and last in pediatric populations, recently announced its first successful in-human implant of the Masa valve. The valve is intended to be used to reconstruct the right ventricular outflow tract (RVOT) and provide a functional pulmonary valve in patients up to age 22. Once implanted, Masa provides a pathway for blood from the right ventricle to the pulmonary arteries, using its design to help prevent backflow into the right ventricle. The valve is a bi-leaflet pulmonary valved conduit . It has an expanded polytetrafluoroethylene (ePTFE) conduit and ePTFE leaflets fixtured to the conduit with polypropylene suture. The device includes a pad-printed design on the outer surface to indicate valve position and direction of flow. Image courtesy of Peca Labs Peca has received Humanitarian Use Device (HUD) and Investigational Device Exemption (IDE) designation from FDA and has begun enrollment for its Masa Valve Early Feasibility Clinical Study at four clinical sites in the United States. One of the study sites included is Children’s Hospital of Philadelphia, which is where the successful first in-human implant recently took place. The valve was reportedly implanted in a 21-month-old child who had previously undergone surgery for a homograft at one year old. The homograft, also known as a human tissue valve, had become severely stenotic and required immediate replacement. In turn, the homograft has been replaced with a 14mm Masa valve and the patient has shown encouraging early results post-procedure, with promising valve functionality on early assessment, according to the company. "This successful implant marks a historic step for our polymeric valve technology that aims to combine the bio-inert benefits of organic tissue and durability of mechanical valves to potentially reduce the need for additional surgeries. The Masa valve materials and design may also help to preserve native tissue that would otherwise be used for a part of the reconstruction and could reduce the amount of medication needed for the patient during their lifetime," Arush Kalra, chief scientific officer and co-founder at Peca Labs, wrote in a statement for MD+DI . "This case brings Masa valve one step closer to being available to children who need such transformational innovation the most, furthering Peca's goal to save and improve lives." Other existing valve implants are made with metal, ceramic or bioprosthetic materials, which can “cause biological responses, lack customizability, cannot be grown, and are destined to fail within five to 10 years,” according to a press release announcing the in-human implant. “Failed conduits require repeat surgeries and interventions, costing more than $100,000 per patient on average, and current interventions for failed implants don’t resolve the core reason for failure.” The Masa valve is named after its inventor, Masahiro Yoshida, MD, PhD , who created the concept after observing issues using biologic valve replacements including calcification, limitations of valve expansion on a growing heart, and shorter times between surgical replacements. Pediatric patients born with valve defects related to a number of congenital heart conditions — pulmonary stenosis, tetralogy of fallot, truncus arteriosus, transposition of great vessels, and pulmonary atresia — require multiple open-heart surgeries from childhood to adulthood. Especially in very young patients, implanted valves and conduits need to be replaced with larger ones as the heart grows. Yoshida, in turn, designed a PTFE implant that was more adaptable to a growing heart, reduced the issues of calcification, and expanded the intervals between replacements. It was years later that three Carnegie Mellon University students formed Peca as a startup near Pittsburgh to commercialize a product based on Dr. Yoshida’s concepts, creating the Masa valve. The company developed the valve to be made entirely out of polymeric materials to help avoid some of the complications that come with the use of biologic valves. Masa does not use biologic or foreign tissue, meaning that the body will not have any immune response to the device. Additionally, its polymeric material helps avoid valve calcification and can be produced in an array of sizes to match each patient’s anatomy. “In designing the Masa valve, we aimed to use our polymer platform to combine the best characteristics of homograft tissue, which reduces the antithrombotic therapy required, and mechanical valves, which offer improved durability, supply availability, and resistance to both calcification and shrinkage,” said Doug Bernstein, CEO at Peca Labs. “We then improved upon them with a novel bi-leaflet design.” Now embarking on the enrollment stage of its clinical study, the company is slated to enroll 10 to 15 patients at up to five sites. The study, which is multi-center, non-randomized, prospective, and interventional, is set to determine the safety and probable benefit of Masa by following implanted subjects for a total of five years post-procedure with a post-op, 30-day, 180-day, and one year follow-up, followed by an annual follow up until five years.

AUSTIN, Texas, Feb. 12, 2021 /PRNewswire/ -- A physician with the Texas Cardiac Arrhythmia Institute (TCAI) at St. David's Medical Center is among the first in the world to participate in a clinical trial to evaluate the safety and efficacy of a new cardiac-specific catheter used during pulsed field ablation (PFA), a new approach to treating patients with atrial fibrillation (A Fib). Andrea Natale, M.D., F.H.R.S., F.A.C.C., F.E.S.C., cardiac electrophysiologist and executive medical director of TCAI, recently participated in the first-in-human trials of this catheter in Europe. PFA uses a controlled electric field instead of thermal energy to ablate or burn cardiac tissue during simple and complex ablation procedures through a process known as irreversible electroporation (IRE). This technique may prevent collateral damage to surrounding tissue during ablation. "The process of irreversible electroporation is an exciting new approach in our field, as it may reduce the risk of complications such as pulmonary stenosis (narrowing of an artery) or esophageal fistulas (abnormal connections between the esophagus and heart). While rare, esophageal fistulas can be life threatening," Dr. Natale said. "This treatment may also reduce or eliminate chest pain that often occurs following surgery, as well as result in a shorter recovery." Physicians will test the catheter on approximately 40 patients in Europe, with in-human trials expected in the U.S. this summer.