Congenital heart abnormalities – which occur in an estimated 1.1% to 1.3% of infants born in the U.S. and worldwide each year – constitute leading cause of birth defect-related deaths. To-date, clinicians have identified and documented almost four dozens distinctive heart defects in newly born ranging from relatively simple and easily correctible abnormalities to complex and multiple anatomical malformations.
The most commonly encountered congenital heart abnormalities accounting for the majority of all diagnosed cases include: ventricular septal defect (VSD); tetralogy of Fallot (TOF); transposition of great vessels (TGV); atrioventricular septal defect (ASD); and coarctation of aorta (COA).
Selection of treatment protocols for congenital heart defects depends on the morphology of the abnormality and its immediate and long-term impact on cardiopulmonary function and patient’s prognosis (threat to survival).
Many asymptomatic patients with minor defects (typically representing unresolved inheritance from normal fetal development, such as trans-septal conduits that are supposed to close at birth) might be put on a “watchful waiting” regime.
Some symptomatic and functionally compromising congenital heart defects can be treated with minimally invasive percutaneous (transcatheter) techniques. To-date, percutaneous repair tools have been developed and clinically tested for several common congenital myocardial abnormalities including: patent ductus arteriosus (PDA), atrial septal defect, ventricular septal defect and patent foramen ovale (PFO). In all instances, the primary objective of the transcatheter approach was to reduce morbidity, mortality and costs associated with the procedure by achieving septal repair or closure via endovascular implantation of specially-configures occluding or sealing devices.
In cases involving complex, debilitating and life threatening congenital myocardial abnormalities (such as Tetralogy of Fallot, transposition of great vessels, etc.) one or several corrective open heart surgeries represent the only route to patient survival. Such surgeries are typically performed during the first year of infant’s life and carry a 5% risk of mortality, on average.
Source: MedMarket Diligence, LLC; Report #C500, “Global Dynamics of Cardiovascular Surgical and Interventional Procedures, 2015-2022.”
Based on the available industry data and MedMarket Diligence estimates, in 2015, approximately 387 thousand congenital heart defect repair procedures were performed worldwide, of which less invasive transcatheter interventions accounted for about 24.3% and open heart corrective surgeries for the remaining 75.7%.
For the period 2015 to 2022, the cumulative global volume of congenital heart defect repair procedures is projected to grow 1.9% per annum to approximately 444 thousand percutaneous and surgical interventions in the year 2022. The usage of transcatheter procedures can be expected to experience significantly faster 9.0% average annual growth (partially at the expense of corrective open heart surgeries for septal defects), reflecting mostly accelerated transition to minimally invasive percutaneous septal defect repair in APAC and ROW market geographies (where the latter techniques currently used only in 15% to 22% of corresponding procedures, compared to 60% to 75% in Western Europe and the U.S.).