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Pulmonary Artery Flow Restrictor As A Bridge To Delayed Norwood: An Initial-strategy Comparison With Primary Norwood In Single-ventricle Neonates
Kenichi Okamura, MD, Matteo Trezzi, MD, Lloyd Felmly, MD, Minoo Kavarana, MD.
Medical University of South Carolina, Charleston, SC, USA.


Objective: Pulmonary artery flow restrictor (PAFR) is a transcatheter bridge to delayed Norwood for high-risk single-ventricle neonates; comparative outcomes vs primary Norwood are unknown.
Methods: Consecutive single-ventricle neonates with intended PAFR-to-Norwood (catheter PAFR + prostaglandin bridge) or primary Norwood were included; biventricular conversion, TAPVR, and classical Hybrid were excluded. Primary endpoint: intention-to-treat transplant-free progression to Stage II, with death/transplant treated as competing events. Major postoperative morbidity: ECMO, dialysis/CRRT, or mechanical ventilation >14 days after Norwood.
Results: Twenty-three neonates were included (primary Norwood, n=15; PAFR-to-Norwood, n=8); median follow-up 8 months. PAFR neonates had lower birth weight (2.9 vs 3.5 kg) and Z-score (−1.1 vs +0.3, p=0.001), with more pre-strategy shock/ECMO (13% vs 0%). Pre-Norwood attrition: 1/8 PAFR, 0/15 primary Norwood. Norwood at median 34 vs 5.5 days. Of 22 Norwood recipients, operative mortality 1/7 vs 1/15. Major-morbidity composite was lower with PAFR (3/7 vs 13/15; Firth OR 0.14, 95% CI 0.02-0.93, p=0.042). NEC and post-Norwood length of stay were similar. Stage II progression: 5/8 vs 10/15 (Gray's p=0.32).
Conclusions: Despite higher baseline risk, PAFR-managed neonates showed no detectable decrement in Stage II progression and a lower observed major-morbidity composite, supporting further evaluation as a bridge strategy.

Patient Characteristics and Post-Norwood Outcomes
CharacteristicOverall(n=23)Primary Norwood(n=15)PAFR-to-Norwood(n=8)P value
Birth weight, kg3.3 (2.9-3.5)3.5 (3.3-3.6)2.9 (2.6-3.0)0.001
Birth weight Z-score−0.2 (−1.0, 0.4)0.3 (−0.1, 0.6)−1.1 (−1.6, −0.8)<0.001
Pre-strategy shock/ECMO, n (%)1 (4)0 (0)1 (13)0.35
Post-Norwood outcomes (Norwood-reached, n=22)
Post-Norwood ECMO, n (%)5/22 (23)5/15 (33)0/7 (0)0.14
Dialysis/CRRT, n (%)13/21 (62)10/14 (71)3/7 (43)0.35
Mechanical ventilation >14 d, n (%)9/21 (43)7/14 (50)2/7 (29)0.64
NEC, n (%)7/21 (33)4/14 (29)3/7 (43)0.64
Major-morbidity composite, n (%)16/22 (73)13/15 (87)3/7 (43)0.042


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