Results of stage I palliation of single ventricle with hypoplastic left heart complex managed with a beating heart strategy
Stiljan Hoxha1
, Fabiola Perrone1
, Paolo Ferrero2, Marco Parolo1, Alessandra Cristofaletti2, Matteo Ciuffreda2, Giovanni Battista Luciani1
Contributions: (I) Conception and design: S Hoxha, GB Luciani; (II) Administrative support: None; (III) Provision of study materials or patients: A Cristofaletti, M Ciuffreda; (IV) Collection and assembly of data: F Perrone, M Parolo; (V) Data analysis and interpretation: S Hoxha, GB Luciani; (VI) Manuscript writing: All authors; (VII) Final approval of manuscript: All authors.
Background: Neonates born with hypoplastic left heart syndrome (HLHS) or complex (HLHC), who undergo stage I palliation with Norwood operation or Damus-Kaye-Stansel (DKS), still carry substantial mortality and morbidity even in the modern era of cardiac surgery. Mortality varies from 10% up to 40% in some Institutions, remaining still one of the highest in pediatric cardiac surgery. In order to reduce mortality and morbidity, we have developed a strategy of selective cerebro-myocardial perfusion (sCMP), allowing to perform the entire operation on the beating heart. The aim of the presents report is to describe our results with such an innovative approach.
Methods: Between December 2016 to December 2024, 12 consecutive patients underwent Norwood-Brawn/double-barrel DKS stage I palliation for single ventricle (SV) palliation associated with ascending aorta and severe arch hypoplasia. All patients were managed with a 3.5 mm modified Blalock-Taussig (mBT) shunt, except one 5-month infant who had a 4 mm shunt. The operation was performed under mild hypothermia with selective constant coronary and cerebral perfusion provided by 2 separate pump rotors.
Results: There were 6 male and 6 female patients, with a median age of 4.5 days [interquartile range (IQR), 2.75–5.25 days] and median body weight of 3.2 kg (IQR, 3.075–3.55 kg). Median cardiopulmonary bypass (CPB) time was 200 min (166–306 min), the median time of myocardial perfusion 80 min (67.5–90 min), the median time of cerebral perfusion time was 160 min (150–176.25 min) and the median time of splanchnic ischemia during cerebro-myocardial perfusion was 47 (40.75–53.5 min). In the series only 2 patients required veno-arterial (VA) extracorporeal membrane oxygenation (ECMO) for failure to wean from bypass. The mean peak troponin T (TnT) was 5,973 (IQR, 1,775.5–8,971) ng/L, while the mean peak lactate level was 8.9 (5.55–11.95) mmol/L. Acute kidney injury, requiring a transient period of peritoneal dialysis was observed in 9 of 12 (75%) patients, while no patients developed liver dysfunction. Postoperative death occurred in 2 patients affected by one of the most severe forms of HLHS (mitro-aortic atresia) due to cardiac dysfunction and failure to wean from VA ECMO support. There was one interstage mortality (between stage I and II) due to progressive heart failure and sepsis. During a median follow-up of 52 months (13–73 months) all late survival were in good clinical conditions without signs of cardiac dysfunction and trivial systemic valve regurgitation. Nine patients completed II stage and six of them stage III palliation of the univentricular heart.
Conclusions: The present experience suggests that a strategy of cerebro-myocardial perfusion is safe, versatile, and feasible in high-risk neonates with HLHC. Encouraging outcomes were noted in terms of cardiac and neurological function, with limited end-organ morbidity.
Keywords: Hypoplastic left heart syndrome (HLHS); hypoplastic left heart complex (HLHC); cerebro-myocardial perfusion (CMP); beating heart; single ventricle (SV)
Submitted Dec 04, 2025. Accepted for publication Mar 24, 2026. Published online Apr 28, 2026.
doi: 10.21037/tp-2025-1-874
Highlight box
Key findings
• Neonates with single ventricle (SV) palliation and ascending with severe arch hypoplasia, including hypoplastic left heart syndrome who undergo stage I palliation either with Norwood operation or Damus-Kaye-Stansel (DKS) have a high rate of mortality and morbidity
What is known and what is new?
• Stage I SV palliation associated with arch hypoplasia, conventionally performed during deep hypothermic circulatory arrest, is linked to neurological and organ ischemic injuries.
• Cerebro-myocardial perfusion improves outcomes in terms of cardiac and neurological function in short and long terms.
What is the implication, and what should change now?
• Cerebro-myocardial perfusion should be considered in all patients undergoing stage I SV palliation with the Norwood procedure and DKS operation.
Introduction
Single ventricle (SV) palliation with ascending aorta and arch hypoplasia, including hypoplastic left heart syndrome (HLHS) or complex (HLHC), encompasses a series of complex congenital cardiac anomalies characterized by underdevelopment of the left heart structures, including the mitral valve, left ventricle, aortic valve, ascending aorta, and aortic arch. Regarding the most severe form of the spectrum of SV, there are four subtypes of HLHS (1). As indicated in the latest European guidelines, it accounted for 2–3% of congenital heart defects in infancy (2).
The method of treatment for this condition has evolved over the years but still carries a substantial morbidity and mortality, especially at the first stage of palliation with the Norwood procedure or Damus-Kaye-Stansel (DKS), with the mortality range going from 10–40%. Also, interstage mortality is still relevant and significant (10–20% of the survivors) (3,4).
In order to reduce mortality and morbidity of patients born with SV and HLHS/C at University of Verona, we developed and implemented a novel tailored selective cerebro-myocardial perfusion (sCMP) strategy, thus conducting the entire operation with brain perfusion and on the beating heart (5-7).
The purpose of this study was to present data on operative, early, and long-term results of a single-center series of consecutive patients with SV (HLHS/C) who had undergone stage I Norwood palliation or DKS with this strategy. We present this article in accordance with the TREND reporting checklist (available at https://tp.amegroups.com/article/view/10.21037/tp-2025-1-874/rc).
Methods
This study was conducted in accordance with the Declaration of Helsinki and its subsequent amendments. The study was waived of ethical approval due to the retrospective nature and individual consent for this retrospective analysis was waived. Between December 2016 to December 2024, 12 consecutive patients underwent Norwood-Brawn stage I palliation or DKS at the University of Verona. Prenatal, diagnosis was present in all patients except one which was referred late at our center from abroad and had an HLHC. After delivery all neonates were transferred to the neonatal and pediatric intensive care unit (ICU) and were put on minimal dose of prostaglandine to maintain the ductus arteriosus opened. None of the patent had extracardiac and genetic syndromes.
As part of the stage I palliation (Norwood operation and DKS), all patients were managed with a Propaten vascular graft (W.L. Gore & Associates INC, Arizona, USA) 3.5 mm modified Blalock-Taussig (mBT) shunt. The operation was performed under mild hypothermia (28–30 ℃) with selective constant coronary and cerebral perfusion provided by 2 separate roller pumps in order to provide respectively 20–25 mL/kg/min and 45–50 mL/kg/min flow. With this strategy, the flow to the coronaries and to the brain was precisely measured and could be tapered based on the metabolic and clinical needs during the operation (6-8). At first, a 3.5/4 mm mBT shunt (depending on patient age and weight) was performed in the lateral aspect of the innominate artery for aortic cannulation, and subsequently cerebral brain perfusion was started. A single-stage venous cannula in the right atrium was used for venous drainage. After cardiopulmonary bypass (CPB) initiation and systemic cooling to the target temperature of 28–30 ℃, a 2 mm coronary perfusion cannula was inserted in the tiny hypoplastic ascending aorta for selective myocardial perfusion. With this setting, the operation was conducted entirely with a beating heart (6). After completing the operation with the modified Norwood-Brawn or double-barrel DKS, the neoaorta was cannulated with a new cannula for systemic perfusion and the mBT shunt was completed by suturing the distal end of the shunt to the right pulmonary artery.
Cerebral and renal near infrared spectroscopy (NIRS) monitoring was performed during the entire surgery. Also, during CPB, the cerebro-myocardial flows were further tailored to the individual metabolic needs, to maintain a myocardial oxygen consumption >70% and NIRS >45% bilaterally.
Demographic, cardiac morphology, operative, and postoperative data were collected, including the need for mechanical circulatory support and complications. Data related to follow-up and subsequent palliative interventions were also retrieved.
Primary endpoints were in-hospital mortality and inter-stage mortality, while secondary endpoints were postoperative outcomes, including SV function and tricuspid valvular dysfunction during the follow-up period.
Statistical analysis
A descriptive statistical analysis was performed. All continuous variables were expressed as median and interquartile range (IQR). Categorical variables were reported as counts and percentages. Distribution of quantitative variables was assessed by inspecting histograms.
Results
A total of 12 neonates underwent SV palliation with Norwood-Brawn or DKS stage I palliation with sCMP. There were 6 male (50%) and 6 female patients (50%), with a median age of 4.5 days (IQR, 2.75–5.25 days) and median body weight of 3.2 kg (IQR, 3.075–3.55 kg) (Table 1). Median CPB time was 200 min (IQR, 166.25–306.25 min), the median time of myocardial perfusion 80 min (IQR, 67.5–90 min). Median of cerebral perfusion time was 160 min (IQR, 150–176.25 min) and the median time of splanchnic ischemia during cerebro-myocardial perfusion was 47 min (IQR, 40.75–53.5 min) (Table 2).
Table 1
| Variable | Value |
|---|---|
| Demographic data | |
| Patients | 12 |
| Sex (M/F) | 6/6 |
| Age at repair, days | 4.5 [2.75–5.25] |
| Weight at repair, kg | 3.2 [3.075–3.55] |
| Urgency | 2 (16.7) |
| Preoperative diagnosis | |
| D-TGA | 1 (8.3) |
| DORV-VSD uncommitted | 1 (8.3) |
| DILV | 1 (8.3) |
| HLHS | 9 (75.0) |
| Mitral atresia/aortic atresia | 3 |
| Mitral stenosis/aortic stenosis | 4 |
| Mitral atresia/aortic stenosis | 1 |
| Mitral stenosis/aortic atresia | 1 |
| Restrictive septal defect | 4 (44.5) |
| Tricuspid insufficiency | |
| Mild | 9 (100.0) |
| Moderate | 0 |
| Severe | 0 |
Data are presented as number, n (%) or median [IQR]. DILV, double inlet left ventricle; DORV, double outlet right ventricle; D-TGA, transposition of the great arteries; F, female; HLHS, hypoplastic left heart syndrome; IQR, interquartile range; M, male; VSD, ventricular septal defect.
Table 2
| Operative variable | Value |
|---|---|
| CPB time, min | 200 [166.25–306.25] |
| Myocardial perfusion time, min | 80 [67.5–90] |
| Cerebral perfusion time, min | 160 [150–176.25] |
| Splanchnic arrest time, min | 47 [40.75–53.5] |
| Surgical technique | |
| Modified Norwood-Brawn, mBT shunt | 9 (75.0) |
| Damus-Kaye-Stansel, mBT shunt | 3 (25.0) |
Data are presented as n (%) or median [IQR]. CPB, cardio-pulmonary bypass; IQR, interquartile range; mBT, modified Blalock-Taussig.
The mean peak troponin T (TnT) was 5,973 (IQR, 1,775.5–8,971) ng/L, while the mean peak lactate level was 8.9 (IQR, 5.55–11.95) mmol/L. Acute kidney injury, requiring a transient period of peritoneal dialysis was observed in 9 of 12 (75%) patients, while no patients developed liver dysfunction.
During the postoperative hospital stay, chylothorax occurred in four patients, no cases of wound infection were observed, and transient phrenic nerve palsy was reported in one patient (Table 3). No permanent neurological events were observed in any of the selected patients who underwent SV palliation at stage I. There were only two patents (22.2%) that experienced seizures after stage II Glenn operation and for which an anticonvulsant therapy was required.
Table 3
| Results | Value |
|---|---|
| Early mortality | 3 (25.0) |
| Lactate peak†, mmol/L | 8.9 [5.55–11.95] |
| Serum AST, U/L | 22.5 [18.2–55.2] |
| Serum ALT, U/L | 27 [16.5–34.5] |
| Serum GGT, U/L | 88 [29.5–125.5] |
| TnT peak, ng/L | 2,130 [1,775.5–8,971] |
| Serum creatine peak, mg/dL | 0.73 [0.58–0.85] |
| Peritoneal dialysis | 9 (75.0) |
| Delayed sternal closure, days | 3 [1–3] |
| Intubation hours | 264 [186–456] |
| Interstage/late mortality | 0 |
| Time to discharge, days | 61 [38–92] |
| Stage II | 8 (66.6) |
| Stage III | 6 (50.0) |
Data are presented as n (%) or median [IQR], unless otherwise specified. †, mean [IQR]. ALT, alanine aminotransferase; AST, aspartate aminotransferase; GGT, gamma-glutamyl transferase; IQR, interquartile range; TnT, troponin T.
Outcome analysis
Early death occurred in 2 (16.7%) patients affected by the most severe form of HLHS (mitro-aortic atresia) due to cardiac dysfunction which required post-cardiotomy. Extracorporeal membrane oxygenation (ECMO) was required and both patients failed to wean from support.
There was one mortality (10%) between stage I and II due to progressive heart failure and sepsis. Nine patients (75%) completed stage II Glenn procedure after a mean interval of 5.4 months (IQR, 4–6 months) and 6 (66.7%) the Fontan procedure after a mean interval of 40.8 months (IQR, 36.25–45 months).
During a median follow-up of 52 months (IQR, 13–73 months) one patient underwent orthotopic heart transplantation because of Fontan failure with preserved ejection fraction 3 years after stage III completion, the remaining surviving patients were in good clinical conditions without signs of ventricular dysfunction and trivial tricuspid valve regurgitation (Figure 1).
Discussion
Severe forms of left heart hypoplasia including HLHS/C and SV with arch hypoplasia are conditions with an unfavorable prognosis, accounting for 25% of deaths during the first week of life if untreated.
Surgical management typically involves three-stage palliative procedures, with stage I Norwood procedure or DKS typically performed within the first week of life. This first stage carries the highest mortality rate due to risk factors such as low birth weight, prematurity, genetic abnormalities, cardiac conditions like intact atrial septum, severely hypoplastic (tiny) aorta, severe atrioventricular valve insufficiency, or non-cardiac conditions (9,10). Furthermore, the stage I procedure is associated with major systemic complications primarily due to hemodynamic instability and ventricular failure.
One of the factors that contributes to the unfavorable outcomes and SV failure is the need for cardioplegic arrest of the heart associated with myocardial ischemia, poorly tolerated especially by single right ventricles (11-15).
The principal objective of our study was to assess the results and postoperative outcome in patients with HLHS undergoing stage I palliation with a dedicated sCMP strategy, thus conducting all the operation with a beating heart and brain.
Aortic arch surgery in infants and neonates had been traditionally performed with the use of deep hypothermic circulatory arrest (DHCA) and lately with the use of selective cerebral perfusion (SCP) and cardiac arrest. The Society of Thoracic Surgeons Congenital Heart Surgery database [2010–2013] showed that SCP was the most widely used strategy (43%), while DHCA and mixed perfusion represented 32% and 16% of cases, respectively (13,14).
However, when comparing the different surgical approaches, the results confirmed that the beating-heart procedure was associated with lower postoperative lactate levels, improved postoperative cardiac function, improved renal function, reduced ECMO use, short ICU stay, and higher survival rates (6-8,15,16).
After experience with SCP and the beating-heart strategy to deal with neonatal aortic arch repair (6,7), it was intuitive to extend the approach to the stage I SV with arch hypoplasia palliation, including the Norwood procedure, in order to reduce complications and improve outcomes.
In the present study, we analyzed 12 consecutive patients of whom 9 with HLHS, observing two post-operative deaths, which occurred both in patients with mitro-aortic atresia and a tiny ascending aorta with a diameter less than 2 mm. This association has one of the worst outcomes in the spectrum of HLHS after the Norwood operation (17). ECMO support in this cohort was necessary only in the two patients who eventually succumbed and failed to wean due to severe cardiac failure and multiorgan failure. There was only one interstage mortality which occurred after stage I SV palliation with double-barrel DKS operation and 4 mm mBT shunt in a 5-month-old who had a double inlet left ventricle with aortic dextroposition originating from the accessory chamber and severe arch hypoplasia. The DKS was performed after initial pulmonary artery banding at 4 months of age because of late referral to our center from a developing country. The patient succumbed in hospital due to progressive heart failure and sepsis.
In multiple case series describing the results of SV palliation with arch hypoplasia and the Norwood operation, the mortality rate remained high, ranging from 10% to 40% even in centers with a high HLHS referral (18). In the present report, even though the volume of patients treated was limited, the mortality rate was in line with the complexity of the pathology. Furthermore, all patients displayed a preserved ventricular function at follow-up. We attributed these satisfactory results to being consistent with the strategy developed for the management of aortic arch pathology, and thus HLHS/C, in our Center (selective and independent cerebro-myocardial perfusion strategy) (6-8).
Siffring et al. described in 2020 the Sustained Total All-Region (STAR) perfusion technique, in order to improve and reduce organ morbidity associated with splanchnic arrest. They conducted a retrospective analysis on 80 patients who underwent the Norwood, comparing those who received antegrade cerebral perfusion with cardiac arrest with those who underwent STAR perfusion. In their series, survival to hospital discharge was remarkably high (97%). Patients in the STAR group demonstrated less systemic and myocardial ischemia, as reflected by reduced peak lactate levels (standard vs. STAR perfusion: 9.9 vs. 8.1 mmol/L, P=0.03). Moreover, time to sternal closure was lower and there was a decreased requirement for ECMO, indicating enhanced postoperative hemodynamic recovery (19-21). These findings were likely correlated with myocardial perfusion, while in terms of splanchnic perfusion the results were comparable between groups. No data showing interstage mortality, morbidity, and mid-term results were reported in the study.
In fact, we believe that SCP in neonates might also provide sufficient blood supply to the lower body through the extensive collateral circuits (6). Therefore, in order to avoid crowding the narrow operative field with additional cannulae, we elected not to adopt the STAR perfusion strategy. Renal function proved normal in 25% of the patients, thus without the need for renal replacement therapy, while no patients experienced severe liver dysfunction. Peak lactate level was in line with the complexity of the neonatal surgery. Regarding cerebral events, none was noted at stage I Norwood procedure and thus not related with cerebro-myocardial perfusion strategy. At stage II Glenn operation only two patients (2/9, 22.2%) experienced seizures and required appropriate anticonvulsant therapy which was subsequently discontinued in the follow-up period. None of the patients had neurological sequalae. Neurological complications are a significant concern in neonatal aortic arch surgery. The incidence and severity of neurological sequelae depends largely on the perfusion strategy used and the underlying pathophysiological mechanisms. As reported by Starr et al. in a multicenter analysis of neonates who had undone neonatal cardiac surgery (SVs and bi-ventricular physiology), a major neurological event had a prevalence of 4.9% in the overall cohort. Analyzing the Norwood cohort, the major neurological injury was nearly 9%. Increased exposure to CPB and circulatory arrest play an important role in the risk of neurological damage, while continuous perfusion (CP) had a protective effect, particularly in high-volume centers. The Norwood cohort, especially those with HLHS, exhibited higher neurological risk due to impaired prenatal brain blood flow and postoperative complications like cardiac arrest and ECMO (22,23).
When dealing with such complex cases in a mid-volume center, it is important to develop alternative perfusion strategies such as selective and independent cerebro-myocardial perfusion in order to reduce cardiac complications and thus end-organ morbidity and mortality. Adopting such a strategy, which we originally described for arch repair in bi-ventricular physiology, to the univentricular SV patients (including HLHS/C) had significantly contributed to improving outcomes in University of Verona.
Limitations of the study
This single-center study has several limitations. First, its retrospective design may introduce selection bias. Second, the limited small sample restricts the statistical power of the analyses. Future multicenter, prospective studies are needed to validate and provide more definitive results with such strategy.
Conclusions
This proof-of-concept study, although based on a limited sample, suggests that a strategy of sCMP is safe, versatile, and feasible in high-risk neonates with SV and HLHS/C. Encouraging outcomes were noted in terms of cardiac and neurological function, with limited end-organ morbidity. In our series, parameters of splanchnic perfusion remained within acceptable ranges, suggesting adequate visceral blood flow.
Acknowledgments
None.
Footnote
Provenance and Peer Review: This article was commissioned by the Guest Editors (Antonio F. Corno and Ali Dodge-Khatami) for the series “Pediatric Heart” published in Translational Pediatrics. The article has undergone external peer review.
Reporting Checklist: The authors have completed the TREND reporting checklist. Available at https://tp.amegroups.com/article/view/10.21037/tp-2025-1-874/rc
Data Sharing Statement: Available at https://tp.amegroups.com/article/view/10.21037/tp-2025-1-874/dss
Peer Review File: Available at https://tp.amegroups.com/article/view/10.21037/tp-2025-1-874/prf
Funding: None.
Conflicts of Interest: All authors have completed the ICMJE uniform disclosure form (available at https://tp.amegroups.com/article/view/10.21037/tp-2025-1-874/coif). The series “Pediatric Heart” was commissioned by the editorial office without any funding or sponsorship. The authors have no other conflicts of interest to declare.
Ethical Statement: The authors are accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved. This study was conducted in accordance with the Declaration of Helsinki and its subsequent amendments. The study was waived of ethical approval due to the retrospective nature and individual consent for this retrospective analysis was waived.
Open Access Statement: This is an Open Access article distributed in accordance with the Creative Commons Attribution-NonCommercial-NoDerivs 4.0 International License (CC BY-NC-ND 4.0), which permits the non-commercial replication and distribution of the article with the strict proviso that no changes or edits are made and the original work is properly cited (including links to both the formal publication through the relevant DOI and the license). See: https://creativecommons.org/licenses/by-nc-nd/4.0/.
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