Congenital defects involving the RVOT require iterative surgical interventions and/or corrections throughout a patient’s growing years and young adulthood. Some of the defects include pulmonary atresia and pulmonary stenosis. Other defects that are more complex and require complex surgeries. Tetralogy of Fallot with pulmonary atresia, truncus arteriosus, double outlet right ventricle or a single pumping chamber combined with multiple complex anomalies. Some congenital defects of the aortic valve are corrected by replacing the failing aortic valve with the patient’s own (native) pulmonary valve. When this is done, a conduit is placed in the RVOT to support pulmonary flow. This procedure is known as the Ross procedure.
There are many types of conduits used for surgery. The current valves available in the market are not suitable to treat many of the needy patients. Re-intervention options for chronic pulmonary regurgitation in the setting of previous RVOT patching are currently limited to surgical valve replacement as current balloon expandable transcatheter valves are not large enough for the dilated native RVOT. Significant challenges have been identified with providing a single self- expanding system that will function over the wide variety of post-operative anatomical variants that exist within this setting.
Pulmonic valve disease
Pulmonic valve disease is a common condition mostly caused by congenital heart disease. Congenital heart disease is the most common type of congenital malformation, accounting for approximately 28% of all congenital malformations. Congenital heart disease has a notable morbidity of 0.4% to 1% in newborns, which translates to 150,000 to 200,000 new patients every year in China. Palpitations, chest distress, asthma, asthenia, and other symptoms may occur when the pulmonic valve area is reduced to about 1/2 of its normal size. Congenital heart disease patients with right ventricular outflow tract stenosis require cardiac-thoracic surgery under extracorporeal circulation in infancy or early childhood. Tetralogy of Fallot (TOF) is the most common congenital heart disease with right ventricular outflow tract stenosis. Classic surgical options include VSD repair, right ventricular outflow tract obstruction and pulmonic artery (annulus and valve) stenosis repair.
The VenusP-Valve System is the first self-expanding nitinol stent for pulmonary valve in Europe known to Venus Medtech. The VenusP-Valve System was designed at 28-36 mm for valve diameter specifically for large RVOTs. The intended purpose of VenusP-Valve is to replace the pulmonary heart valve with an artificial valve using a minimally invasive percutaneous approach, to treat right ventricular outflow tract (RVOT) dysfunction and specifically for the dilated outflow tracts to restore pulmonary valve function.
CONTRAINDICATIONS Known hypersensitivity or contraindication to aspirin, heparin, ticlopidine, clopidogrel, nitinol, or sensitivity to contrast media which cannot be adequately pre-medicated. Septicemia, including active endocarditis. Recent myocardial infarction (< 30 days). Echocardiographic evidence of intracardiac mass, thrombus, or vegetation. Any Contraindication of extracorporeal assist. Evolutive or recent cerebral vascular accident (CVA). Obstruction of the central veins. Bleeding diathesis, coagulopathy, patient refusal of blood transfusion. Creatinine Clearance Calculator (CCR) <20mL/min. Pregnancy. Patients with known allergies to porcine materials. Patients who are breastfeeding.
POTENTIAL RISKS Associated with transfemoral access and general anesthesia death. Cardiovascular or vascular injury, such as perforation or damage (dissection) of vessels, myocardium, or valvar structures, that may require intervention. Arrhythmia. Pericardial effusion/cardiac tamponade. Perforation or damage of vessels. Embolization: air or thrombus.Hematoma. Hemorrhage requiring transfusion. Hypertension/hypotension. Infection including endocarditis and septicemia. Systemic peripheral ischemia/nerve injury. Allergic dye reaction. Anesthesia reactions. Radiation injury. Fever……
POTENTIAL RISKS Associated with the VenusP-Valve System Myocardial infarction. Arteriovenous fistula. Bleeding. Coronary artery compression. Device embolization requiring intervention. Device explant. Device migration or malposition requiring intervention. Device thrombosis requiring intervention. Emergency cardiac surgery. Endocarditis. Hemolysis. Hemolytic anemia. Important Information About Stent Fracture. In some patients, the wire frame (stent) of the VenusP-Valve System may fracture because of the forces it is exposed to in the body.In some cases, the fractured stent may not require any additional treatment. However, the patients should realize a fractured stent has the potential to become serious and could result in the need for another procedure. The doctor will decide the best treatment option. In the VenusP-Valve System CE Clinical Interim Report data, eleven (11) stent fractures (14.5%) have been identified, which did not affect the Valve functionality and no need for additional treatment.