Subtitle VII, Aviation Programs, describes in more detail the scope of the agency's authority.This rulemaking is promulgated under the authority described in Subtitle VII, Part A. Subpart I, Section 40103. Under that section, the FAA is charged with prescribing regulations to assign the use of airspace necessary to ensure the safety of aircraft and the efficient use of airspace. This regulation is within the scope of that authority as it amends controlled airspace at Smithfield, NC.
Introduction:
The hybrid procedure (bilateral PA bands [PAB] ± ductal stent) is a contemporary management option for infants with critical left heart obstruction. We sought to determine patient/procedural characteristics, subsequent outcomes and associated factors after PAB in a multi-institutional study.
Methods:
From 2005-2019, 214 of 1236 infants from 24 Congenital Heart Surgeons’ Society participating institutions underwent PAB. Median follow-up was 7 years. Parametric hazard modeling with competing risk methodology was performed to determine risk and associated factors for end-states of biventricular repair (BVR), Fontan, transplantation (Tx) or death without an end-state.
Results:
PAB was performed at a median age of 7 days & median weight of 3.1 kg. Intention of PAB varied - institutional preference (21%), non-cardiac comorbidities (20%), BVR consideration (12%), etc. Ductal stent was placed in 69% of patients (74% same day as PAB) and atrial septal interventions occurred in 61% (24% same day as PAB). Preoperative comorbidities (e.g. prematurity, genetic syndromes, neurological diagnoses, etc.) were present in 70%. At 5 years, 9% had reached BVR, 36% Fontan and 12% Tx (21/26 Tx immediately after PAB), with 35% having died and 8% alive without an end-state (Figure). Significant factors associated with BVR were presence of VSD and ductal stent; with Tx: earlier era, underlying aortic atresia, older age and greater weight at PAB, and absence of ductal stent; with death: low birth weight, ≥ moderate tricuspid valve regurgitation before PAB, & older age at PAB.
Conclusions:
Heterogeneity is prevalent in patient/procedural characteristics and subsequent procedures and outcomes after PAB, possibly influenced by institutional preference and different intended management pathways. There is important mortality and <50% of patients achieve a Fontan or BVR. Preoperative factors influence the use of this approach and thus are an important influence on outcomes.
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