In-hospital interstage for HLHS and HLHS variants
Research type
Research Study
Full title
Impact of in-hospital interstage program on comprehensive survival after Norwood stage-one and Norwood stage-two operation for HLHS and HLHS variants
IRAS ID
235600
Contact name
Guido Michielon
Contact email
Sponsor organisation
Royal Brompton Hospital
Duration of Study in the UK
1 years, 0 months, 0 days
Research summary
Background: HLHS is a complex congenital heart disease where the left-sided structures of the heart do no develop properly during foetal life and are unsuitable to sustain the circulation in post-natal life. A staged surgical approach has been devised to treat this otherwise lethal condition. The first operation (Norwood stage-one) is performed within the first week of life, followed by a Norwood stage-two operation at 4-6 months of life and finally completed by a third operation at the age of three years. The mortality of the staged approach is approximately 20% for Norwood stage-one and 5% for Norwood stage-two. Interstage mortality between Norwood stage-one and Norwood stage-two HLHS accounts for an additional 12-20% in current series, mainly due to sudden cardiac events resulting in circulatory collapse. This interstage mortality is thought to be related to the fragile model of circulation physiology which results after the neonatal Norwood stage-one operation. The Norwood stage-two operation restitutes a more stable and reliable physiology, therefore virtually neutralizing the risk of death after stage-two completion
Scientific Rational & Hypothesis: In-hospital interstage facilitates escalation of care after Norwood stage-one and could favorably impact on interstage mortality and management of interstage morbidity. Therefore the comprehensive survival up to completion of Norwood stage-2 could be enhanced.
Objective Evaluation of the preliminary experience with the HLHS in-hospital interstage programme at RBHT, since its beginning in May 2015. Primary and novel end-point will be the evaluation of the comprehensive Norwood stage-one and stage-two survival as an aggregate survival until hospital discharge after stage-two completion. Secondary end-point will be the evaluation and management of the interstage morbidity and complications requiring escalation of care, including unplanned reoperation and catheter reintervention.
Methods: a retrospective single-centre (RBHT) study will be conducted on the patients with diagnosis of HLHS and HLHS-variants who underwent a Norwood stage-two operation during the same hospitalization as Norwood stage-1 or hybrid procedure, since the beginning of the in-hospital interstage programme at RBHT in May 2015. Outcomes assessed will be aggregate mortality for Norwood stage-one and Norwood stage-two, freedom from escalation of care during interstage, freedom from unplanned reoperations and/or catheter reinterventions during interstage, intensive care length of stay for every single procedure and total hospital stay.
Survival analysis for Norwood stage-one, Norwood stage-two and Norwood interstage will be assessed in a comprehensive fashion and compared with published data in the literature.REC name
East of England - Essex Research Ethics Committee
REC reference
17/EE/0417
Date of REC Opinion
24 Oct 2017
REC opinion
Further Information Favourable Opinion