Interventional fetal balloon valvuloplasty for congenital heart disease—current shortcomings and possible perspectives

Abstract

Fetal cardiac interventions are new and relatively unknown investigational options for modifying congenital heart disease in utero. Techniques for safer access to the fetus must be improved, and selection criteria for patients for whom these procedures are potentially beneficial must be developed. Currently, antenatal cardiac intervention attempts are being made to either prevent or reverse hydrops in fetuses with cardiac valve disease or outflow tract obstruction or to recruit hypoplastic ventricles. Most important are early detection and referral of these fetuses, thereby enabling timely procedures with improved outcomes. However, performing successful fetal cardiac interventions requires multidisciplinary collaboration between obstetricians, pediatric cardiologists, pediatric cardiac surgeons, and anesthesiologists, as each discipline provides specific skills for these critically ill babies.

A new ethical framework to determine acceptable risks in fetal therapy trials

“…The regulations may thus allow fetal therapy trials with very high risks for the pregnant person or the fetus – as long as the anticipated benefits are high enough (and the risks are minimized and caused by the fetal therapy itself). Indeed, some trials, for example, have involved a 20%–30% fetal mortality rate 10 …”