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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| Characteristic | Overall(n=23) | Primary Norwood(n=15) | PAFR-to-Norwood(n=8) | P value |
| Birth weight, kg | 3.3 (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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