Short and mid-term outcomes of ductal graft with bilateral pulmonary banding in hypoplastic left heart syndrome and variants

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This technique is designed to avoid the high risk classical Norwood stage 1 operation and to avoid the need for first stage invasive catheter interventions and interstage catheter interventions when ductal stent placement is not feasible in developing countries with limited resources. Methods Between June 2015 and December 2022, 14 patients with hypoplastic left heart syndrome and variants were treated using this procedure at our center. Polytetrafluoroethylene graft was used for ductal graft procedure and polytetrafluoroethylene bands were used for bilateral pulmonary banding. Atrial septectomy was done selectively. Patients with adequate left heart growth underwent biventricular repair and pulmonary debanding. Patients without left heart growth underwent cavopulmonary anastomosis or necessary intermediate surgical revisions. Results Seven patients out of 14 reached the second stage. Two received biventricular repair, three underwent bidirectional cavopulmonary anastomosis, and two required repeat palliations other than bidirectional cavopulmonary anastomosis. Conclusions Modifications of the Norwood procedure is an ongoing process due to the complex nature of hypoplastic left heart syndrome and variants. As experience grows, the mortality associated with ductal graft and bilateral pulmonary banding procedure may decrease, making this technique an alternative for centers where classical Norwood operation or hybrid palliation is not possible, especially in developing countries with limited resources. We might predict promising outcomes, especially for patients with hypoplastic left heart complex where biventricular repair is expected. Ductal graft Hypoplastic left heart syndrome Modified Norwood procedure Figures Figure 1 Figure 2 Figure 3 Introduction Hypoplastic Left Heart Syndrome (HLHS) is a pathology resulting from inadequate development of the left-sided structures of the heart, including the mitral valve, left ventricle, aortic valve, ascending aorta, and aortic arch. The degree of hypoplasia varies among patients. HLHS is observed in 3% of newborns with congenital heart disease and is responsible for 23% of cardiac-related deaths in the first week of life [1, 2, 3]. Babies born with HLHS, and its variants require a patent ductus arteriosus (PDA) and a non-restrictive interatrial opening to survive. In the first weeks of life, these infants undergo Norwood stage 1 palliation (atrial septectomy, aortic arch reconstruction, and systemic-pulmonary shunt) or hybrid procedures (bilateral pulmonary artery banding, PDA stent, balloon atrial septostomy, and atrial septal stent) as preparation for total cavopulmonary anastomosis [4, 5, 6]. Norwood stage 1 palliation is a high-risk surgical procedure with a mortality rate of 2-68% [7, 8, 9, 10, 11, 12]. Hybrid palliation, which includes pulmonary artery banding alongside PDA stenting and, if necessary, balloon atrial septostomy and atrial septal stenting, is preferred to reduce early deaths in select patients. The mortality of the hybrid technique varies between 2.5-58% [8]. And is advantageous because it does not require cardiopulmonary bypass (CPB) and is less invasive compared to Norwood stage 1 palliation. However, the hybrid approach has significant disadvantages, such as the need for hybrid or advanced catheterization rooms that are designed to combine interventional and surgical techniques, the risk of PDA stent migration, reduced antegrade flow through the PDA, narrowing of the transverse aorta (retrograde coarctation), and the need for intervention on restrictive atrial septal defect (ASD), necessitating repeated procedures. After the hybrid method, a complex reoperation involving longer CPB and cross-clamp (CC) duration is usually necessary at the second stage of palliation [13, 14]. To reduce complications associated with ductal stents and avoid repeated interventional catheterizations, we developed a Modified Norwood technique, which involves placing a polytetrafluoroethylene (PTFE) (Gore-Tex; WL Gore & Associates Inc, Flagstaff, Arizona) ductal tube graft between the pulmonary artery and aorta instead of a PDA stent, as well as bilateral pulmonary artery banding and atrial septectomy when necessary. This operation is named as the Modified Norwood (ductal graft and bilateral pulmonary banding) procedure. Figure 1 shows a surgical drawing of the cardiac anatomy with this technique. This study retrospectively assesses the short and medium-term outcomes of patients operated on with the Modified Norwood procedure. Patients and Methods Ethical statement: The Acibadem Mehmet Ali Aydinlar University medical research evaluation committee approved this retrospective, a single-centre study on 14 March 2024 (approval number: 2024-4/160). The requirement for informed patient consent was waived owing to the retrospective nature of this study. In Stage 1 palliation, the aim is to ensure the continuity of systemic circulation through the Patent Ductus Arteriosus (PDA) while balancing systemic and pulmonary circulation. In this study, continuity of systemic circulation in patients was maintained by placing a PTFE tube graft in place of the ductus arteriosus. Concurrently, to reduce pulmonary flow, bilateral pulmonary artery banding was performed, and atrial septectomy was done in patients with restrictive atrial septal defects. Patients: Fourteen patients diagnosed with HLHS and variants between June 2015 to December 2022, who underwent bilateral pulmonary banding and ductal graft placement at our center were included in the study. Demographic characteristics, perioperative data, early and mid-term postoperative results, repeat interventions and surgeries if performed, and final clinical statuses were recorded. Operative Method: Under general anaesthesia, median sternotomy was performed, followed by cannulation of the right atrium and pulmonary artery. After temporarily closing both pulmonary arteries with encircling silastic tapes and cooling to an average of 18 degrees, cardioplegia is administered, (selective cerebral and coronary perfusion techniques were used in selected patients) PDA was resected. PTFE tube graft (diameter 6-10 mm and length 10-20 mm) was anastomosed between the aortic arch and the pulmonary artery bifurcation. Atrial septectomy was performed. PTFE tube graft bands of 3.5 mm or 4 mm diameter and a length of 2-3 mm were placed on the right and left pulmonary arteries, and bands were fixed to the adventitia to prevent migration. Figure 2 shows intraoperative images of the ductal graft and pulmonary bands. Postoperative Follow-up: Patients were monitored with echocardiography postoperatively for ductal graft flow, pulmonary band gradients, aortic arch flow, ventricular size and function, and atrioventricular valve function in the intensive care unit and hospital stay, then monthly or when necessary. Before bidirectional cavopulmonary anastomosis (BCPA) or any other major surgical procedure, cardiac catheterization was performed to evaluate ductal graft flow, descending aorta, ascending aorta, and pulmonary artery pressures, and pulmonary vascular resistance. Subsequent Operations: Following Stage 1 palliation, patients were evaluated for biventricular repair. Those with adequate left ventricle, mitral, and aortic dimensions (z-scores > -2) underwent biventricular repair and pulmonary debanding. Patients without adequate growth of left heart structures were assessed for BCPA by catheterization at 4-6 months. At this stage, patients with restrictive ductal graft diameter (pressure gradient between ascending and descending aorta) underwent PTFE tube revision (upgrade), and those with significantly reduced pulmonary flow due to tight banding underwent band revision (upgrade). Statistical Analysis IBM SPSS version 20 software package was used for the statistical analysis of the data. Categorical variables were presented as number and percentage, continuous variables as mean and standard deviation (mean ± SD), and non-homogenous distributions as median and range. Results Fourteen patients were included in the study who were operated between June 2015 and December 2022. Ten (72%) were male. The average follow-up period was 32±15 months. Table 1 displays the characteristics and outcomes of patients operated on with the ductal graft and bilateral pulmonary banding technique. Eight patients (60%) had HLHS, 3 (21%) had Shone's complex (patients with aortic stenosis, mitral stenosis, and aortic arch hypoplasia but with adequate left ventricular size), 2 (14%) had aortic and aortic arch hypoplasia along with HLHS variant, and 1 (7%) was diagnosed with HLHS variant and interrupted aortic arch. At the first surgery, the average age was 8±5 days, and the average weight was 3±0.5 kg. The average cardiopulmonary bypass time was 101±28 minutes, cross-clamp time was 51±15 minutes, selective innominate artery perfusion time in selected patients was 53±12 minutes, and mean hypothermia was 18.7±2.2 degrees Celsius. Atrial septectomy was performed on 11 patients (78%). The intensive care stay was 15±5 days, and hospital stay was 22±8 days. Two patients one with aortic valve hypoplasia, diffuse aortic arch hypoplasia, ventricular septal defect (VSD) and one with HLHS, needed extracorporeal membrane oxygenation (ECMO) support and were weaned from ECMO after an average of 3 days. Nine patients required peritoneal dialysis. Five patients (36%) expired in the intensive care period (3 due to multiorgan failure, 2 due to sepsis, systemic ventricular dysfunction, and low output syndrome). Nine patients (64%) were discharged. A significant correlation was found between the year of operation and the mortality rate (p:0.03 r: -0.49). There were 2 sudden deaths at home after stage 1 operation. Of the 7 patients reaching the second stage, biventricular repair was performed on 2 patients. Bidirectional cavopulmonary anastomosis was done on 3 patients. The other two underwent repeated palliation and revision surgeries (ductal PTFE tube graft revision n:2, pulmonary band revision n:2). Patients' ages during the second operation averaged 6.2 ± 2.5 months. Two patients who underwent BCPA were lost due to multiorgan dysfunction. Between stage 1 palliation and the BCPA surgery, one patient diagnosed with aortic valve and aortic hypoplasia, VSD(HLHS) variant required pulmonary band revision, another with transposition of the great arteries plus right ventricular and aortic arch hypoplasia required pulmonary band revision and ductal graft revision, and in a patient with HLHS, ductal graft revision was performed during BCPA procedure. One patient with HLHS required ductal graft and pulmonary band revision after BCPA. During the second stage of operations, instead of aortic arch reconstruction, pulmonary artery debanding and reconstruction, and ductal graft takedown surgery, ductal graft revision and/or pulmonary artery band revision, and BCPA operations were performed, if necessary, Figure 3 shows the results of patients who proceeded to the second stage operation. Table 2 provides patient characteristics, operative findings, second-stage operations, and mortality results. After an average follow-up of 32 months, one of five patients with a diagnosis of HLHS post-BCPA surgery is waiting for Fontan operation. Patient with transposition of the great arteries, VSD, hypoplastic right ventricle, and aortic arch hypoplasia has undergone revision surgery twice and is waiting for BCPA surgery. Biventricular repair (Yasui operation) is planned for the patient with aortic valve and aortic arch hypoplasia and VSD (HLHS variant). Two patients with interrupted aortic arch and VSD and two with Shone complex and aortic arch hypoplasia underwent biventricular repair. All relevant data supporting the findings of this study are contained within the manuscript and its Supplementary Information files. Readers can directly access these data to verify the study’s conclusions and conduct further analyses. Discussion HLHS has the highest mortality among congenital heart diseases in the neonatal period. A choice between pregnancy termination or postnatal repetitive palliative surgeries and interventions is required for those diagnosed antenatally. Due to the need for emergency intervention after birth, it is recommended that delivery takes place in congenital heart surgery centers. The Norwood stage 1 operation is often the preferred procedure at these centers. Norwood stage I palliation in HLHS is a complex operation and carries high risks [15, 16]. A hybrid approach that combines interventional and surgical techniques has been developed as an alternative to this high-risk surgery [13]. The hybrid procedure’s advantages are probably better neurodevelopmental outcomes, shorter operative period and shorter hospital stays by avoiding cardiopulmonary bypass and deep hypothermic circulatory arrest in the sensitive newborn period. Disadvantages include disrupting pulmonary artery growth, retrograde coarctation, difficulty in manipulating ASD, and the need for more interstage interventions. Particularly in premature or unstable high-risk newborns with low birth weight, the hybrid approach is preferred. While the placement of a stent in the PDA in the hybrid procedure is considered advantageous due to lower mortality risk and shorter hospital stays than classical Norwood operation, the need for likely repeated interventions remains a significant disadvantage [17]. The search for alternative palliation methods to reduce neonatal mortality and the number of interventions between two stages in HLHS is ongoing. Our study brings a new palliation technique, particularly for centers where PDA stenting is not available with high rates of classical Norwood procedure mortality and morbidity, or there are no centers to transfer the HLHS patients for classical Norwood or hybrid Norwood procedure. It might also attract the attention of centers where ductal stenting or classical Norwood procedure related complication rates and repeated intervention rates are high. And in the modified Norwood technique (ductal graft and bilateral pulmonary banding), a PTFE tube graft is placed between the aorta and pulmonary artery instead of a PDA stent, and PTFE bands were placed at right and left pulmonary arteries. This technique aims to reduce classical Norwood operation risks and to avoid hybrid procedure complications such as coarctation or retrograde flow issues due to PDA stent migration. In our study, the early mortality following the ductal graft and bilateral pulmonary banding procedure was 35%. Survival rates in centers experienced with HLHS complex patients in stage 1 Norwood or hybrid groups can reach 85-90%. However, mortality can vary between 25-40% in high-risk cases with prematurity, low birth weight, chromosomal anomalies, or pulmonary venous obstruction. Some centers prefer the hybrid method for high-risk patient groups to avoid CPB and myocardial ischemia. However, hybrid procedure risk is still substantial and reoperations after hybrid procedures still carries high risk. Pre-BCPA mortality in our patient group was 50% (n=7). Five patients died during the early postoperative intensive care period, and there were 2 sudden deaths at home after discharge (interstage mortality). The main causes of mortality in patients lost in the early period were multiorgan dysfunction (n=3) and sepsis (n=2). A decrease in mortality has been observed at our center in correlation with the learning curve of this new surgical technique. Patients with HLHS reaching the second stage and receiving BCPA did not require intervention during the interstage period. Ductal graft revision and/or pulmonary artery band revision was performed on one of these patients during the BCPA stage, and on another after the BCPA stage. Patients with great artery transposition, VSD, right ventricular hypoplasia and aortic arch hypoplasia underwent ductal graft revision, pulmonary band revision. Like the hybrid method, this method indicates the need for repeated operations like ductal graft revision, with the disadvantage of potentially smaller pulmonary artery diameters. However, less need for these interventions was observed during the interstage period. It is also noted that in patients treated with the hybrid method, underdeveloped pulmonary artery structures and the need for repeated interventions were reported. After the hybrid procedure, diffuse pulmonary artery narrowing and a low NAKATA index have been linked to increased mortality and morbidity, often necessitating extensive pulmonary artery reconstruction during cavopulmonary anastomosis stage and Fontan stage [17,18,19,20,21]. When comparing the novel surgical approach for hypoplastic left heart syndrome (HLHS) detailed in our study with the one presented by Pontailler et al., several key differences and similarities emerge [16]. Both studies aim to address the high mortality rates associated with traditional Norwood procedures by introducing alternative techniques inspired by the hybrid Norwood approach. Our study focuses on using a PTFE ductal graft combined with bilateral pulmonary artery banding and atrial septectomy, while Pontailler et al. utilize a pulmonary homograft for ductal reconstruction alongside similar pulmonary banding and atrial septectomy. One significant similarity between the two techniques is their shared goal of minimizing surgical risks. Both approaches avoid the complications associated with PDA stenting, such as stent migration and retrograde coarctation. However, a critical difference lies in the materials used for ductal reconstruction; our study employs a PTFE graft, whereas Pontailler et al. use a pulmonary homograft. This difference in materials may influence long-term outcomes and the need for subsequent interventions. Our study reports a 35% early-stage mortality rate, with significant improvements in patient outcomes over time as surgical expertise increase. In contrast, Pontailler et al. achieved a lower early mortality rate of 6.7%, though they also noted substantial interstage mortality at 28.5%. Both studies highlight the importance of reducing interstage interventions, but our technique showed no need for such interventions in patients progressing to the second stage. Pontailler et al., while reducing early mortality, still encountered interstage deaths, particularly in their initial patient cohort. Continued refinement and long-term follow-up are essential to fully evaluate the efficacy and safety of these novel approaches in managing HLHS. This surgical method was applied not only to patients with HLHS but also to those with hypoplastic left heart complex, including those with Shone's complex and interrupted aortic arch. Two patients went on to two-ventricular repair without needing interim intervention, and mortality was lower in this group (n=2; 33%); two patients with Shone's complex died from sepsis. The ductal graft method proved suitable even for patients who were candidates for complex biventricular repair. In neonates with marginally developed left heart structures, the need for early high-risk surgery was eliminated by applying bilateral pulmonary artery banding and ductal grafting, allowing for the possibility of later-stage biventricular repair without being hindered by early high-risk surgery. Over time, the growth of the left heart structures facilitated decision-making process and increased the likelihood of biventricular repair. This method does not pose risks such as aortic coarctation, restriction of the atrial septal defect, or systemic flow reduction, common in the hybrid method, thus making it preferable for patients who are candidates for biventricular repair as an alternative to the classic Norwood procedure. Post-hybrid procedure stage 2 operation, which requires aortic arch reconstruction and pulmonary artery reconstruction, is a more extensive surgical procedure compared to classical Norwood Stage 2 [17]. Similarly, in the ductal graft technique, stage 2 involves complex stages such as aortic arch reconstruction, pulmonary artery debanding and reconstruction, ductal graft takedown, and creating BCPA, which could lead to problems like increased ventricular dysfunction or atrioventricular valve insufficiency following a long cardioplegic arrest and CPB time. For these reasons, ductal graft revision and/or pulmonary artery band revision were performed, and BCPA operations were done when circumstances are optimised. Aortic arch reconstruction and ductal graft takedown procedures are planned to be done before the third stage, the Fontan operation, thereby reducing the surgical risks that aortic arch reconstruction could bring, such as prolonged cross-clamping, myocardial ischemia, deep hypothermia, selective cerebral perfusion, and total circulatory arrest. The limitations of this study include its retrospective nature, single institution experience, patients with wide spectrum of complex pathologies and small number of patients. Conclusion Modifications of the Norwood procedure is an ongoing process due to the complex nature of hypoplastic left heart syndrome and variants. As experience grows, the mortality associated with ductal graft and bilateral pulmonary banding procedure may decrease, making this technique an alternative for centers where classical Norwood operation or hybrid palliation is not possible, especially in developing countries with limited resources. We might predict promising outcomes, especially for patients with hypoplastic left heart complex where biventricular repair is expected. ABBREVIATIONS HLHS Hypoplastic Left Heart Syndrome PDA Patent ductus arteriosus CPB Cardiopulmonary bypass ASD. Atrial septal defect CC Cross-clamp PTFE Polytetrafluoroethylene BCPA Bidirectional cavopulmonary anastomosis VSD Ventricular septal defect ECMO Extracorporeal membrane oxygenation Declarations Author contributions Ayla Oktay: Conceptualization; Data curation; Formal analysis; Investigation; Methodology; Project administration; Visualization; Writing—original draft; Writing—review & editing. Ahmet Arnaz: Methodology; Writing—original draft; Writing—review & editing. Canan Ayabakan: Writing—review & editing. Tayyar Sarioglu: Project administration; Supervision; Yusuf Yalcinbas: Project administration; Supervision; Visualization; Writing—review & editing. Conflict of interest: none declared. References Grossfeld P.Nie S, Lin L, Wang Lu, Anderson RH. Hypoplastic left heart syndrome: A new paradigm for old disease. J Cardiovasc Dev Dis. 2019 Feb 23;6(1) Yabrodi M, Mastropietro CW. Hypoplastic left heart syndrome: from comfort care to long-term survival. Pediatr Res. 2017 Jan;81 (1-2):142-149 Alayunt EA, Atay Y, Özyürek AR, Aşkar FZ, Değirmenciler K, Arpaçay A. Norwood stage 1 operation with Sano modification. Turk Gogus Kalp Dama 2008;16 (2):122-125 McHugh KE, Hillman DG, Gurka MJ, Gutgesell HP. Three stage palliation of hypoplastic left heart syndrome in the University Health System Consortium. Congenital Heart Dis. 2010 Jan-Feb; 5 (1):8-15 Güzeltaş A, Tanıdır IC, Kasar T, Haydın S, Ödemiş E. Hybrid stenting of restrictive atrial septum in an infant with hypoplastic left heart syndrome after hybrid stage 1 palliation. Anatol J Cardiol. 2015; 15 E4-E7 Schranz D, Esmaelli A, Akıntürk H. Hypoplastic left heart: stage -I will be performed interventionally, soon. Pediatr Cardiol 2021 (42) 727-735 Pasqualı SK, Jacobs JP, He X, Homik CP, Jaquiss RD, Jacobs ML et al. The complex relationship between center volume and outcome in patients undergoing the Norwood operation. Ann Thorac Surg 2012; 93: 1556-1562. Erek E, Aydın S, Temur B, Önalan MA, Suzan D et al. Outcomes of hybrid and Norwood stage I procedures for the treatment of hypoplastic left heart syndrome and its variants. Turk Gogus Kalp Dama. 2020;28 (2): 282-293 Özdemir F, Korun O, Dedemoğlu M, Çiçek M, Biçer M et al. Outcomes of Norwood procedure with hypoplastic left heart syndrome: our 12-year single center experience. Turk Gogus Kalp Dama 2022; 30 (1):26-35 Çelik M, Gökdemir M, Cındık N, Günaydın AÇ, Aygün F, Özkan M. New approach in stage 1 surgery for hypoplastic left heart syndrome: preliminary outcomes. Cardiol Young. 2023; Sep; 33 (9): 1544-1549 Başaran M, Tunçer E, Güzelmeriç F, Cine N, Öner N et al. İntroduction to a Norwood program an emerging economy: learning curve of a single center. Heart Surg Forum. 2013; Dec; 16 (6): E313-8 Yıldırım Ö, Bakhshaliyev S, Kilercik H, Balaban İ, Zübarioğlu U et al. Early results of ring-reinforced conduit and curved porcine patch in Sano Norwood procedure. J Card Surg. 2019 ;34 (5): 279-84 Galantowicz M, Cheatam JP, Philips A, Cua CL, Hoffman TM, Hıll SL et al. Hybrid approach for hypoplastic left heart syndrome: intermediate results after the learning curve. Ann Thorac Surg 2008; 85: 2063-70 Haydın S, Ödemiş E, Öztürk E, Onan S, Güzeltaş A. Hybrid palliation and subsequently comprehensive stage II repair for hypoplastic left heart syndrome: the first experience from our country. Turk Gogus Kalp Dama 2015: 23 (1):146-149 Roeleved PP, Axelrod DM, Klugman D, Jones MB, Cahani KN. Hypoplastic left heart syndrome: From fetus to Fontan. Cardiol Young. 2018; September: 1275-1288 Pontailler M, Gaudin R, Lenoir M, Haydar A, Kraiche D et al. Hypoplastic left heart syndrome: a novel surgical strategy for small-volume centres? Eur J Cardiothorac Surg 2017;1003-1008 Baba K, Kotani Y, Chetan D, Chatuvedi RR, Lee KJ, et al. Hybrid versus Norwood strategies for single- ventricle palliation. Circulation. 2012;126:123–131 Heaton-Bauser H, Price K, Weber R, El-Said H. Stenting of Patent Ductus Arteriosus: A meta-analysis and literature Review. Journal of the Society for Cardiovascular Angiography and Interventions1 2022.100392:1-9 Yerebakan C, Valeske K, Elmontaser H, Hofmann K, Schranz D. Hybrid therapy for hypoplastic left heart syndrome: Myth, alternative, or standard? J Thorac cardiovasc surg 2016;151:1112-1123 Davies R.R, Radtke W.A, Klenk D, Pizarro C. Bilateral pulmonary arterial banding results in an increased need for subsequent pulmonary artery interventions. J Thorac Cardiovasc Surg. 2014;147:706-712 Pizarro C, Davies R.R, Woodford E., Radtke W.A. Improving early outcomes following hybrid procedure for patients with single ventricle and systemic outflow obstruction: defining risk factors. Eur J Cardiothorac Surg. 2015;47:995-1000 Tables Table 1. Patient characteristics, operation, and outcomes Patient Diagnosis Age at Operation (days) Body Weight (kg) Second Operation Age at Second Operation (months) Additional Operation Cause of Death 1. HLHS 6 3,5 - - Multiorgan failure 2. HLHS 1 2,2 - - Multiorgan failure 3. HLHS 4 3,5 Glenn 8.5 - Multiorgan failure 4. HLHS 3 3,5 - - Sudden death at home 5. HLHS 28 3,5 Glenn + ductal graft revision 6.5 - Multiorgan failure 6. AS+MS+arch hypoplasia 12 2,3 - - Sepsis (klebsiella) 7. HLHS 3 3 - - Multiorgan failure 8. Aortic valve and aortic hypoplasia+ VSD 13 3,5 Band revision 4 Band release - 9. TGA+right ventricle and arch hypoplasia 4 3,5 Ductal graft and band revision 7 Band release - 10. HLHS 5 3,1 - - Sudden death at home 11. Aortic interruption+VSD 22 2,1 Interruption Repair, VSD closure and debanding 5 - - 12. HLHS 12 3 Glenn 10 Ductal graft and band revision - 13. AS+MS+arch hypoplasia 10 3 Coarctation Repair, debanding 2,5 - - 14. AS+MS+arch hypoplasia 1 2,6 - - Sepsis (candida) AS: aortic stenosis, HLHS: hypoplastic left heart syndrome, MS: mitral stenosis, TGA: transposition of great arteries, VSD: ventricular septal defect Table 2. Patient Characteristics, Surgical Data, Subsequent Operations, and Mortality Outcomes Demographic Data Male Gender Operation Age (days) Weight (kg) 10 (72 %) 8±5; 8 (1-28) 3 ± 0.5 Operative Data CPB (min) Cross-clamp time (min) Selective perfusion (min) Hypothermia (°C) 101 ±28 51 ±15 53 ±12 18.7 ±2.2 Postoperative Data Intubation (days) Peritoneal dialysis ECMO ICU stay (days) Hospital stay (days) 14 ±5 9 (64 %) 2 (14 %) 15±5 22±8 Second Operation Complete repair Glenn and/or ductal graft and/or band revision Third Operation Ductal graft and/or band revision 2 (14 %) 5 (35%) 3 (21%) Mortality During the first operation After the first operation, at home At the second operation 5 (35%) 2 (14%) 2 (14%) Additional Declarations No competing interests reported. Cite Share Download PDF Status: Published Journal Publication published 22 Aug, 2024 Read the published version in Pediatric Cardiology → Version 1 posted Editorial decision: Revision requested 24 Jul, 2024 Reviews received at journal 24 Jul, 2024 Reviews received at journal 23 Jul, 2024 Reviews received at journal 23 Jul, 2024 Reviewers agreed at journal 21 Jul, 2024 Reviews received at journal 21 Jul, 2024 Reviews received at journal 21 Jul, 2024 Reviewers agreed at journal 20 Jul, 2024 Reviews received at journal 19 Jul, 2024 Reviewers agreed at journal 17 Jul, 2024 Reviewers agreed at journal 17 Jul, 2024 Reviewers agreed at journal 17 Jul, 2024 Reviewers agreed at journal 17 Jul, 2024 Reviews received at journal 16 Jul, 2024 Reviewers agreed at journal 16 Jul, 2024 Reviewers agreed at journal 15 Jul, 2024 Reviewers agreed at journal 15 Jul, 2024 Reviewers agreed at journal 15 Jul, 2024 Reviewers agreed at journal 15 Jul, 2024 Reviewers agreed at journal 15 Jul, 2024 Reviewers agreed at journal 15 Jul, 2024 Reviewers invited by journal 15 Jul, 2024 Editor assigned by journal 08 Jul, 2024 Submission checks completed at journal 08 Jul, 2024 First submitted to journal 07 Jul, 2024 You are reading this latest preprint version Research Square lets you share your work early, gain feedback from the community, and start making changes to your manuscript prior to peer review in a journal. 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PA: Pulmonary artery\u003c/p\u003e","description":"","filename":"3.png","url":"https://assets-eu.researchsquare.com/files/rs-4700683/v1/7a531ac9f0fc697b5f7a5d73.png"},{"id":63300611,"identity":"7e49fcea-482c-4d5c-9e21-ab687f4ee3ff","added_by":"auto","created_at":"2024-08-26 16:15:34","extension":"pdf","order_by":0,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":1183551,"visible":true,"origin":"","legend":"","description":"","filename":"manuscript.pdf","url":"https://assets-eu.researchsquare.com/files/rs-4700683/v1/fd44d6c8-4622-4f8d-9846-781cc7c532be.pdf"}],"financialInterests":"No competing interests reported.","formattedTitle":"Short and mid-term outcomes of ductal graft with bilateral pulmonary banding in hypoplastic left heart syndrome and variants","fulltext":[{"header":"Introduction","content":"\u003cp\u003eHypoplastic Left Heart Syndrome (HLHS) is a pathology resulting from inadequate development of the left-sided structures of the heart, including the mitral valve, left ventricle, aortic valve, ascending aorta, and aortic arch. The degree of hypoplasia varies among patients. HLHS is observed in 3% of newborns with congenital heart disease and is responsible for 23% of cardiac-related deaths in the first week of life [1, 2, 3].\u003c/p\u003e\n\u003cp\u003eBabies born with HLHS, and its variants require a patent ductus arteriosus (PDA) and a non-restrictive interatrial opening to survive. In the first weeks of life, these infants undergo Norwood stage 1 palliation (atrial septectomy, aortic arch reconstruction, and systemic-pulmonary shunt) or hybrid procedures (bilateral pulmonary artery banding, PDA stent, balloon atrial septostomy, and atrial septal stent) as preparation for total cavopulmonary anastomosis [4, 5, 6]. Norwood stage 1 palliation is a high-risk surgical procedure with a mortality rate of 2-68% [7, 8, 9, 10, 11, 12]. Hybrid palliation, which includes pulmonary artery banding alongside PDA stenting and, if necessary, balloon atrial septostomy and atrial septal stenting, is preferred to reduce early deaths in select patients. The mortality of the hybrid technique varies between 2.5-58% [8]. And is advantageous because it does not require cardiopulmonary bypass (CPB) and is less invasive compared to Norwood stage 1 palliation. However, the hybrid approach has significant disadvantages, such as the need for hybrid or advanced catheterization rooms that are designed to combine interventional and surgical techniques, the risk of PDA stent migration, reduced antegrade flow through the PDA, narrowing of the transverse aorta (retrograde coarctation), and the need for intervention on restrictive atrial septal defect (ASD), necessitating repeated procedures. After the hybrid method, a complex reoperation involving longer CPB and cross-clamp (CC) duration is usually necessary at the second stage of palliation [13, 14].\u003c/p\u003e\n\u003cp\u003eTo reduce complications associated with ductal stents and avoid repeated interventional catheterizations, we developed a Modified Norwood technique, which involves placing a polytetrafluoroethylene (PTFE) (Gore-Tex; WL Gore \u0026amp; Associates Inc, Flagstaff, Arizona)\u0026nbsp;ductal tube graft between the pulmonary artery and aorta instead of a PDA stent, as well as bilateral pulmonary artery banding and atrial septectomy when necessary. This operation is named as the Modified Norwood (ductal graft and bilateral pulmonary banding) procedure. Figure 1 shows a surgical drawing of the cardiac anatomy with this technique.\u003c/p\u003e\n\u003cp\u003eThis study retrospectively assesses the short and medium-term outcomes of patients operated on with the Modified Norwood procedure.\u003c/p\u003e"},{"header":"Patients and Methods","content":"\u003cp\u003e\u003cstrong\u003eEthical statement:\u0026nbsp;\u003c/strong\u003eThe Acibadem Mehmet Ali Aydinlar University medical research evaluation committee approved this retrospective, a single-centre study on 14 March 2024 (approval number: 2024-4/160). The requirement for informed patient consent was waived owing to the retrospective nature of this study.\u003c/p\u003e\n\u003cp\u003eIn Stage 1 palliation, the aim is to ensure the continuity of systemic circulation through the Patent Ductus Arteriosus (PDA) while balancing systemic and pulmonary circulation. In this study, continuity of systemic circulation in patients was maintained by placing a PTFE tube graft in place of the ductus arteriosus. Concurrently, to reduce pulmonary flow, bilateral pulmonary artery banding was performed, and atrial septectomy was done in patients with restrictive atrial septal defects.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003ePatients:\u003c/strong\u003e Fourteen patients diagnosed with HLHS and variants between June 2015 to December 2022, who underwent bilateral pulmonary banding and ductal graft placement at our center were included in the study. Demographic characteristics, perioperative data, early and mid-term postoperative results, repeat interventions and surgeries if performed, and final clinical statuses were recorded.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eOperative Method:\u003c/strong\u003e Under general anaesthesia, median sternotomy was performed, followed by cannulation of the right atrium and pulmonary artery. After temporarily closing both pulmonary arteries with encircling silastic tapes and cooling to an average of 18 degrees, cardioplegia is administered, (selective cerebral and coronary perfusion techniques were used in selected patients) PDA was resected. PTFE tube graft (diameter 6-10 mm and length 10-20 mm) was anastomosed between the aortic arch and the pulmonary artery bifurcation. Atrial septectomy was performed. PTFE tube graft bands of 3.5 mm or 4 mm diameter and a length of 2-3 mm were placed on the right and left pulmonary arteries, and bands were fixed to the adventitia to prevent migration. Figure 2 shows intraoperative images of the ductal graft and pulmonary bands.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003ePostoperative Follow-up:\u003c/strong\u003e Patients were monitored with echocardiography postoperatively for ductal graft flow, pulmonary band gradients, aortic arch flow, ventricular size and function, and atrioventricular valve function in the intensive care unit and hospital stay, then monthly or when necessary. Before bidirectional cavopulmonary anastomosis (BCPA) or any other major surgical procedure, cardiac catheterization was performed to evaluate ductal graft flow, descending aorta, ascending aorta, and pulmonary artery pressures, and pulmonary vascular resistance.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eSubsequent Operations:\u003c/strong\u003e Following Stage 1 palliation, patients were evaluated for biventricular repair. Those with adequate left ventricle, mitral, and aortic dimensions (z-scores \u0026gt; -2) underwent biventricular repair and pulmonary debanding. Patients without adequate growth of left heart structures were assessed for BCPA by catheterization at 4-6 months. At this stage, patients with restrictive ductal graft diameter (pressure gradient between ascending and descending aorta) underwent PTFE tube revision (upgrade), and those with significantly reduced pulmonary flow due to tight banding underwent band revision (upgrade).\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eStatistical Analysis\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eIBM SPSS version 20 software package was used for the statistical analysis of the data. Categorical variables were presented as number and percentage, continuous variables as mean and standard deviation (mean ± SD), and non-homogenous distributions as median and range.\u003c/p\u003e"},{"header":"Results","content":"\u003cp\u003eFourteen patients were included in the study who were operated between June 2015 and December 2022. Ten (72%) were male. The average follow-up period was 32±15 months. Table 1 displays the characteristics and outcomes of patients operated on with the ductal graft and bilateral pulmonary banding technique. Eight patients (60%) had HLHS, 3 (21%) had Shone's complex (patients with aortic stenosis, mitral stenosis, and aortic arch hypoplasia but with adequate left ventricular size), 2 (14%) had aortic and aortic arch hypoplasia along with HLHS variant, and 1 (7%) was diagnosed with HLHS variant and interrupted aortic arch.\u003c/p\u003e\n\u003cp\u003eAt the first surgery, the average age was 8±5 days, and the average weight was 3±0.5 kg. The average cardiopulmonary bypass time was 101±28 minutes, cross-clamp time was 51±15 minutes, selective innominate artery perfusion time in selected patients was 53±12 minutes, and mean hypothermia was 18.7±2.2 degrees Celsius. Atrial septectomy was performed on 11 patients (78%). The intensive care stay was 15±5 days, and hospital stay was 22±8 days. Two patients one with aortic valve hypoplasia, diffuse aortic arch hypoplasia, ventricular septal defect (VSD) and one with HLHS, needed extracorporeal membrane oxygenation (ECMO) support and were weaned from ECMO after an average of 3 days. Nine patients required peritoneal dialysis. Five patients (36%) expired in the intensive care period (3 due to multiorgan failure, 2 due to sepsis, systemic ventricular dysfunction, and low output syndrome). Nine patients (64%) were discharged. A significant correlation was found between the year of operation and the mortality rate (p:0.03 r: -0.49). There were 2 sudden deaths at home after stage 1 operation.\u003c/p\u003e\n\u003cp\u003eOf the 7 patients reaching the second stage, biventricular repair was performed on 2 patients. Bidirectional cavopulmonary anastomosis was done on 3 patients. The other two underwent repeated palliation and revision surgeries (ductal PTFE tube graft revision n:2, pulmonary band revision n:2). Patients' ages during the second operation averaged 6.2 ± 2.5 months. Two patients who underwent BCPA were lost due to multiorgan dysfunction. Between stage 1 palliation and the BCPA surgery, one patient diagnosed with aortic valve and aortic hypoplasia, VSD(HLHS) variant required pulmonary band revision, another with transposition of the great arteries plus right ventricular and aortic arch hypoplasia required pulmonary band revision and ductal graft revision, and in a patient with HLHS, ductal graft revision was performed during BCPA procedure. One patient with HLHS required ductal graft and pulmonary band revision after BCPA. During the second stage of operations, instead of aortic arch reconstruction, pulmonary artery debanding and reconstruction, and ductal graft takedown surgery, ductal graft revision and/or pulmonary artery band revision, and BCPA operations were performed, if necessary, Figure 3 shows the results of patients who proceeded to the second stage operation. Table 2 provides patient characteristics, operative findings, second-stage operations, and mortality results.\u003c/p\u003e\n\u003cp\u003eAfter an average follow-up of 32 months, one of five patients with a diagnosis of HLHS post-BCPA surgery is waiting for Fontan operation. Patient with transposition of the great arteries, VSD, hypoplastic right ventricle, and aortic arch hypoplasia has undergone revision surgery twice and is waiting for BCPA surgery. Biventricular repair (Yasui operation) is planned for the patient with aortic valve and aortic arch hypoplasia and VSD (HLHS variant). Two patients with interrupted aortic arch and VSD and two with Shone complex and aortic arch hypoplasia underwent biventricular repair.\u003c/p\u003e\n\u003cp\u003eAll relevant data supporting the findings of this study are contained within the manuscript and its Supplementary Information files. Readers can directly access these data to verify the study’s conclusions and conduct further analyses.\u003c/p\u003e"},{"header":"Discussion","content":"\u003cp\u003eHLHS has the highest mortality among congenital heart diseases in the neonatal period. A choice between pregnancy termination or postnatal repetitive palliative surgeries and interventions is required for those diagnosed antenatally. Due to the need for emergency intervention after birth, it is recommended that delivery takes place in congenital heart surgery centers. The Norwood stage 1 operation is often the preferred procedure at these centers. Norwood stage I palliation in HLHS is a complex operation and carries high risks [15, 16]. A hybrid approach that combines interventional and surgical techniques has been developed as an alternative to this high-risk surgery [13]. The hybrid procedure’s advantages are probably better neurodevelopmental outcomes, shorter operative period and shorter hospital stays by avoiding cardiopulmonary bypass and deep hypothermic circulatory arrest in the sensitive newborn period. Disadvantages include disrupting pulmonary artery growth, retrograde coarctation, difficulty in manipulating ASD, and the need for more interstage interventions. Particularly in premature or unstable high-risk newborns with low birth weight, the hybrid approach is preferred. While the placement of a stent in the PDA in the hybrid procedure is considered advantageous due to lower mortality risk and shorter hospital stays than classical Norwood operation, the need for likely repeated interventions remains a significant disadvantage [17]. The search for alternative palliation methods to reduce neonatal mortality and the number of interventions between two stages in HLHS is ongoing.\u003c/p\u003e\n\u003cp\u003eOur study brings a new palliation technique, particularly for centers where PDA stenting is not available with high rates of classical Norwood procedure mortality and morbidity, or there are no centers to transfer the HLHS patients for classical Norwood or hybrid Norwood procedure. It might also attract the attention of centers where ductal stenting or classical Norwood procedure related complication rates and repeated intervention rates are high. \u0026nbsp;And in the modified Norwood technique (ductal graft and bilateral pulmonary banding), a PTFE tube graft is placed between the aorta and pulmonary artery instead of a PDA stent, and PTFE bands were placed at right and left pulmonary arteries. This technique aims to reduce classical Norwood operation risks and to avoid hybrid procedure complications such as coarctation or retrograde flow issues due to PDA stent migration.\u003c/p\u003e\n\u003cp\u003eIn our study, the early mortality following the ductal graft and bilateral pulmonary banding procedure was 35%. Survival rates in centers experienced with HLHS complex patients in stage 1 Norwood or hybrid groups can reach 85-90%. However, mortality can vary between 25-40% in high-risk cases with prematurity, low birth weight, chromosomal anomalies, or pulmonary venous obstruction. Some centers prefer the hybrid method for high-risk patient groups to avoid CPB and myocardial ischemia. However, hybrid procedure risk is still substantial and reoperations after hybrid procedures still carries high risk.\u003c/p\u003e\n\u003cp\u003ePre-BCPA mortality in our patient group was 50% (n=7). Five patients died during the early postoperative intensive care period, and there were 2 sudden deaths at home after discharge (interstage mortality). The main causes of mortality in patients lost in the early period were multiorgan dysfunction (n=3) and sepsis (n=2). A decrease in mortality has been observed at our center in correlation with the learning curve of this new surgical technique.\u003c/p\u003e\n\u003cp\u003ePatients with HLHS reaching the second stage and receiving BCPA did not require intervention during the interstage period. Ductal graft revision and/or pulmonary artery band revision was performed on one of these patients during the BCPA stage, and on another after the BCPA stage. Patients with great artery transposition, VSD, right ventricular hypoplasia and aortic arch hypoplasia underwent ductal graft revision, pulmonary band revision. Like the hybrid method, this method indicates the need for repeated operations like ductal graft revision, with the disadvantage of potentially smaller pulmonary artery diameters. However, less need for these interventions was observed during the interstage period. It is also noted that in patients treated with the hybrid method, underdeveloped pulmonary artery structures and the need for repeated interventions were reported. After the hybrid procedure, diffuse pulmonary artery narrowing and a low NAKATA index have been linked to increased mortality and morbidity, often necessitating extensive pulmonary artery reconstruction during cavopulmonary anastomosis stage and Fontan stage \u0026nbsp;[17,18,19,20,21].\u003c/p\u003e\n\u003cp\u003eWhen comparing the novel surgical approach for hypoplastic left heart syndrome (HLHS) detailed in our study with the one presented by Pontailler et al., several key differences and similarities emerge [16]. \u0026nbsp;Both studies aim to address the high mortality rates associated with traditional Norwood procedures by introducing alternative techniques inspired by the hybrid Norwood approach. Our study focuses on using a PTFE ductal graft combined with bilateral pulmonary artery banding and atrial septectomy, while Pontailler et al. utilize a pulmonary homograft for ductal reconstruction alongside similar pulmonary banding and atrial septectomy. One significant similarity between the two techniques is their shared goal of minimizing surgical risks. Both approaches avoid the complications associated with PDA stenting, such as stent migration and retrograde coarctation. However, a critical difference lies in the materials used for ductal reconstruction; our study employs a PTFE graft, whereas Pontailler et al. use a pulmonary homograft. This difference in materials may influence long-term outcomes and the need for subsequent interventions. Our study reports a 35% early-stage mortality rate, with significant improvements in patient outcomes over time as surgical expertise increase. In contrast, Pontailler et al. achieved a lower early mortality rate of 6.7%, though they also noted substantial interstage mortality at 28.5%. Both studies highlight the importance of reducing interstage interventions, but our technique showed no need for such interventions in patients progressing to the second stage. Pontailler et al., while reducing early mortality, still encountered interstage deaths, particularly in their initial patient cohort. Continued refinement and long-term follow-up are essential to fully evaluate the efficacy and safety of these novel approaches in managing HLHS.\u003c/p\u003e\n\u003cp\u003eThis surgical method was applied not only to patients with HLHS but also to those with hypoplastic left heart complex, including those with Shone's complex and interrupted aortic arch. Two patients went on to two-ventricular repair without needing interim intervention, and mortality was lower in this group (n=2; 33%); two patients with Shone's complex died from sepsis.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eThe ductal graft method proved suitable even for patients who were candidates for complex biventricular repair. In neonates with marginally developed left heart structures, the need for early high-risk surgery was eliminated by applying bilateral pulmonary artery banding and ductal grafting, allowing for the possibility of later-stage biventricular repair without being hindered by early high-risk surgery. Over time, the growth of the left heart structures facilitated decision-making process and increased the likelihood of biventricular repair. This method does not pose risks such as aortic coarctation, restriction of the atrial septal defect, or systemic flow reduction, common in the hybrid method, thus making it preferable for patients who are candidates for biventricular repair as an alternative to the classic Norwood procedure.\u003c/p\u003e\n\u003cp\u003ePost-hybrid procedure stage 2 operation, which requires aortic arch reconstruction and pulmonary artery reconstruction, is a more extensive surgical procedure compared to classical Norwood Stage 2 [17]. Similarly, in the ductal graft technique, stage 2 involves complex stages such as aortic arch reconstruction, pulmonary artery debanding and reconstruction, ductal graft takedown, and creating BCPA, which could lead to problems like increased ventricular dysfunction or atrioventricular valve insufficiency following a long cardioplegic arrest and CPB time. For these reasons, ductal graft revision and/or pulmonary artery band revision were performed, and BCPA operations were done when circumstances are optimised. Aortic arch reconstruction and ductal graft takedown procedures are planned to be done before the third stage, the Fontan operation, thereby reducing the surgical risks that aortic arch reconstruction could bring, such as prolonged cross-clamping, myocardial ischemia, deep hypothermia, selective cerebral perfusion, and total circulatory arrest.\u003c/p\u003e\n\u003cp\u003eThe limitations of this study include its retrospective nature, single institution experience, patients with wide spectrum of complex pathologies and small number of patients.\u003c/p\u003e"},{"header":"Conclusion","content":"\u003cp\u003eModifications of the Norwood procedure is an ongoing process due to the complex nature of hypoplastic left heart syndrome and variants. As experience grows, the mortality associated with ductal graft and bilateral pulmonary banding procedure may decrease, making this technique an alternative for centers where classical Norwood operation or hybrid palliation is not possible, especially in developing countries with limited resources. We might predict promising outcomes, especially for patients with hypoplastic left heart complex where biventricular repair is expected.\u003c/p\u003e"},{"header":"ABBREVIATIONS ","content":"\u003cp\u003eHLHS \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp;Hypoplastic Left Heart Syndrome\u0026nbsp;\u003c/p\u003e\n\u003cp\u003ePDA \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp;Patent ductus arteriosus\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eCPB \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp;Cardiopulmonary bypass\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eASD. \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; Atrial septal defect\u003c/p\u003e\n\u003cp\u003eCC \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp;Cross-clamp\u0026nbsp;\u003c/p\u003e\n\u003cp\u003ePTFE \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp;Polytetrafluoroethylene\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eBCPA \u0026nbsp; \u0026nbsp; \u0026nbsp; Bidirectional cavopulmonary anastomosis\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eVSD \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; Ventricular septal defect\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eECMO \u0026nbsp; \u0026nbsp; \u0026nbsp;Extracorporeal membrane oxygenation\u0026nbsp;\u003c/p\u003e"},{"header":"Declarations","content":"\u003cp\u003e\u003cstrong\u003eAuthor contributions\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eAyla Oktay: Conceptualization; Data curation; Formal analysis; Investigation; Methodology; Project administration; Visualization; Writing\u0026mdash;original draft; Writing\u0026mdash;review \u0026amp; editing. Ahmet Arnaz: Methodology; Writing\u0026mdash;original draft; Writing\u0026mdash;review \u0026amp; editing. Canan Ayabakan: Writing\u0026mdash;review \u0026amp; editing. Tayyar Sarioglu: Project administration; Supervision; Yusuf Yalcinbas: Project administration; Supervision; Visualization; Writing\u0026mdash;review \u0026amp; editing.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eConflict of interest:\u003c/strong\u003e none declared.\u003c/p\u003e"},{"header":"References","content":"\u003col\u003e\n\u003cli\u003eGrossfeld P.Nie S, Lin L, Wang Lu, Anderson RH. Hypoplastic left heart syndrome: A new paradigm for old disease. J Cardiovasc Dev Dis. 2019 Feb 23;6(1)\u003c/li\u003e\n\u003cli\u003eYabrodi M, Mastropietro CW. Hypoplastic left heart syndrome: from comfort care to long-term survival. Pediatr Res. 2017 Jan;81 (1-2):142-149\u003c/li\u003e\n\u003cli\u003eAlayunt EA, Atay Y, \u0026Ouml;zy\u0026uuml;rek AR, Aşkar FZ, Değirmenciler K, Arpa\u0026ccedil;ay A. Norwood stage 1 operation with Sano modification. Turk Gogus Kalp Dama 2008;16 (2):122-125\u003c/li\u003e\n\u003cli\u003eMcHugh KE, Hillman DG, Gurka MJ, Gutgesell HP. Three stage palliation of hypoplastic left heart syndrome in the University Health System Consortium. Congenital Heart Dis. 2010 Jan-Feb; 5 (1):8-15\u003c/li\u003e\n\u003cli\u003eG\u0026uuml;zeltaş A, Tanıdır IC, Kasar T, Haydın S, \u0026Ouml;demiş E. Hybrid stenting of restrictive atrial septum in an infant with hypoplastic left heart syndrome after hybrid stage 1 palliation. Anatol J Cardiol. 2015; 15 E4-E7\u003c/li\u003e\n\u003cli\u003eSchranz D, Esmaelli A, Akınt\u0026uuml;rk H. Hypoplastic left heart: stage -I will be performed interventionally, soon. Pediatr Cardiol 2021 (42) 727-735\u003c/li\u003e\n\u003cli\u003ePasqualı SK, Jacobs JP, He X, Homik CP, Jaquiss RD, Jacobs ML et al. The complex relationship between center volume and outcome in patients undergoing the Norwood operation. Ann Thorac Surg 2012; 93: 1556-1562. \u003c/li\u003e\n\u003cli\u003eErek E, Aydın S, Temur B, \u0026Ouml;nalan MA, Suzan D et al. Outcomes of hybrid and Norwood stage I procedures for the treatment of hypoplastic left heart syndrome and its variants. Turk Gogus Kalp Dama. 2020;28 (2): 282-293\u003c/li\u003e\n\u003cli\u003e\u0026Ouml;zdemir F, Korun O, Dedemoğlu M, \u0026Ccedil;i\u0026ccedil;ek M, Bi\u0026ccedil;er M et al. Outcomes of Norwood procedure with hypoplastic left heart syndrome: our 12-year single center experience. Turk Gogus Kalp Dama 2022; 30 (1):26-35\u003c/li\u003e\n\u003cli\u003e\u0026Ccedil;elik M, G\u0026ouml;kdemir M, Cındık N, G\u0026uuml;naydın A\u0026Ccedil;, Ayg\u0026uuml;n F, \u0026Ouml;zkan M. New approach in stage 1 surgery for hypoplastic left heart syndrome: preliminary outcomes. Cardiol Young. 2023; Sep; 33 (9): 1544-1549\u003c/li\u003e\n\u003cli\u003eBaşaran M, Tun\u0026ccedil;er E, G\u0026uuml;zelmeri\u0026ccedil; F, Cine N, \u0026Ouml;ner N et al. İntroduction to a Norwood program an emerging economy: learning curve of a single center. Heart Surg Forum. 2013; Dec; 16 (6): E313-8\u003c/li\u003e\n\u003cli\u003eYıldırım \u0026Ouml;, Bakhshaliyev S, Kilercik H, Balaban İ, Z\u0026uuml;barioğlu U et al. Early results of ring-reinforced conduit and curved porcine patch in Sano Norwood procedure. J Card Surg. 2019 ;34 (5): 279-84\u003c/li\u003e\n\u003cli\u003eGalantowicz M, Cheatam JP, Philips A, Cua CL, Hoffman TM, Hıll SL et al. Hybrid approach for hypoplastic left heart syndrome: intermediate results after the learning curve. Ann Thorac Surg 2008; 85: 2063-70\u003c/li\u003e\n\u003cli\u003eHaydın S, \u0026Ouml;demiş E, \u0026Ouml;zt\u0026uuml;rk E, Onan S, G\u0026uuml;zeltaş A. Hybrid palliation and subsequently comprehensive stage II repair for hypoplastic left heart syndrome: the first experience from our country. Turk Gogus Kalp Dama 2015: 23 (1):146-149\u003c/li\u003e\n\u003cli\u003eRoeleved PP, Axelrod DM, Klugman D, Jones MB, Cahani KN. Hypoplastic left heart syndrome: From fetus to Fontan. Cardiol Young. 2018; September: 1275-1288\u003c/li\u003e\n\u003cli\u003ePontailler M, Gaudin R, Lenoir M, Haydar A, Kraiche D et al. Hypoplastic left heart syndrome: a novel surgical strategy for small-volume centres? Eur J Cardiothorac Surg 2017;1003-1008\u003c/li\u003e\n\u003cli\u003eBaba K, Kotani Y, Chetan D, Chatuvedi RR, Lee KJ, et al. Hybrid versus Norwood strategies for single- ventricle palliation. Circulation. 2012;126:123\u0026ndash;131\u003c/li\u003e\n\u003cli\u003eHeaton-Bauser H, Price K, Weber R, El-Said H. Stenting of Patent Ductus Arteriosus: A meta-analysis and literature Review. Journal of the Society for Cardiovascular Angiography and Interventions1 2022.100392:1-9\u003c/li\u003e\n\u003cli\u003eYerebakan C, Valeske K, Elmontaser H, Hofmann K, Schranz D. Hybrid therapy for hypoplastic left heart syndrome: Myth, alternative, or standard? J Thorac cardiovasc surg 2016;151:1112-1123\u003c/li\u003e\n\u003cli\u003eDavies R.R, Radtke W.A, Klenk D, Pizarro C. Bilateral pulmonary arterial banding results in an increased need for subsequent pulmonary artery interventions. J Thorac Cardiovasc Surg. 2014;147:706-712 \u003c/li\u003e\n\u003cli\u003ePizarro C, Davies R.R, Woodford E., Radtke W.A. Improving early outcomes following hybrid procedure for patients with single ventricle and systemic outflow obstruction: defining risk factors. Eur J Cardiothorac Surg. 2015;47:995-1000\u003c/li\u003e\n\u003c/ol\u003e"},{"header":"Tables","content":"\u003cp\u003eTable 1. Patient characteristics, operation, and outcomes\u003c/p\u003e\n\u003ctable border=\"0\" cellspacing=\"0\" cellpadding=\"0\" width=\"709\"\u003e\n \u003ctbody\u003e\n \u003ctr\u003e\n \u003ctd width=\"9.30888575458392%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cstrong\u003e\u0026nbsp;\u003c/strong\u003e\u003cstrong\u003ePatient\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"17.348377997179124%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cstrong\u003eDiagnosis\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"10.719322990126939%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cstrong\u003eAge at Operation (days)\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"8.039492242595205%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cstrong\u003eBody Weight (kg)\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"13.258110014104373%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cstrong\u003eSecond Operation\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"11.988716502115656%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cstrong\u003eAge at Second Operation (months)\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"11.988716502115656%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cstrong\u003eAdditional Operation\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"17.348377997179124%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cstrong\u003eCause of Death\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"9.30888575458392%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cstrong\u003e1.\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"17.348377997179124%\" valign=\"top\"\u003e\n \u003cp\u003eHLHS\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"10.719322990126939%\" valign=\"top\"\u003e\n \u003cp\u003e6\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"8.039492242595205%\" valign=\"top\"\u003e\n \u003cp\u003e3,5\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"13.258110014104373%\" valign=\"top\"\u003e\n \u003cp\u003e-\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"11.988716502115656%\" valign=\"top\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"11.988716502115656%\" valign=\"top\"\u003e\n \u003cp\u003e-\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"17.348377997179124%\" valign=\"top\"\u003e\n \u003cp\u003eMultiorgan failure\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"9.30888575458392%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cstrong\u003e2.\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"17.348377997179124%\" valign=\"top\"\u003e\n \u003cp\u003eHLHS\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"10.719322990126939%\" valign=\"top\"\u003e\n \u003cp\u003e1\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"8.039492242595205%\" valign=\"top\"\u003e\n \u003cp\u003e2,2\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"13.258110014104373%\" valign=\"top\"\u003e\n \u003cp\u003e-\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"11.988716502115656%\" valign=\"top\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"11.988716502115656%\" valign=\"top\"\u003e\n \u003cp\u003e-\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"17.348377997179124%\" valign=\"top\"\u003e\n \u003cp\u003eMultiorgan failure\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"9.30888575458392%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cstrong\u003e3.\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"17.348377997179124%\" valign=\"top\"\u003e\n \u003cp\u003eHLHS\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"10.719322990126939%\" valign=\"top\"\u003e\n \u003cp\u003e4\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"8.039492242595205%\" valign=\"top\"\u003e\n \u003cp\u003e3,5\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"13.258110014104373%\" valign=\"top\"\u003e\n \u003cp\u003eGlenn\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"11.988716502115656%\" valign=\"top\"\u003e\n \u003cp\u003e8.5\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"11.988716502115656%\" valign=\"top\"\u003e\n \u003cp\u003e-\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"17.348377997179124%\" valign=\"top\"\u003e\n \u003cp\u003eMultiorgan failure\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"9.30888575458392%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cstrong\u003e4.\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"17.348377997179124%\" valign=\"top\"\u003e\n \u003cp\u003eHLHS\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"10.719322990126939%\" valign=\"top\"\u003e\n \u003cp\u003e3\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"8.039492242595205%\" valign=\"top\"\u003e\n \u003cp\u003e3,5\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"13.258110014104373%\" valign=\"top\"\u003e\n \u003cp\u003e-\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"11.988716502115656%\" valign=\"top\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"11.988716502115656%\" valign=\"top\"\u003e\n \u003cp\u003e-\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"17.348377997179124%\" valign=\"top\"\u003e\n \u003cp\u003eSudden death at home\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"9.30888575458392%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cstrong\u003e5.\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"17.348377997179124%\" valign=\"top\"\u003e\n \u003cp\u003eHLHS\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"10.719322990126939%\" valign=\"top\"\u003e\n \u003cp\u003e28\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"8.039492242595205%\" valign=\"top\"\u003e\n \u003cp\u003e3,5\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"13.258110014104373%\" valign=\"top\"\u003e\n \u003cp\u003eGlenn + ductal graft revision\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"11.988716502115656%\" valign=\"top\"\u003e\n \u003cp\u003e6.5\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"11.988716502115656%\" valign=\"top\"\u003e\n \u003cp\u003e-\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"17.348377997179124%\" valign=\"top\"\u003e\n \u003cp\u003eMultiorgan failure\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"9.30888575458392%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cstrong\u003e6.\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"17.348377997179124%\" valign=\"top\"\u003e\n \u003cp\u003eAS+MS+arch hypoplasia\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"10.719322990126939%\" valign=\"top\"\u003e\n \u003cp\u003e12\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"8.039492242595205%\" valign=\"top\"\u003e\n \u003cp\u003e2,3\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"13.258110014104373%\" valign=\"top\"\u003e\n \u003cp\u003e-\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"11.988716502115656%\" valign=\"top\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"11.988716502115656%\" valign=\"top\"\u003e\n \u003cp\u003e-\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"17.348377997179124%\" valign=\"top\"\u003e\n \u003cp\u003eSepsis (klebsiella)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"9.30888575458392%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cstrong\u003e7.\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"17.348377997179124%\" valign=\"top\"\u003e\n \u003cp\u003eHLHS\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"10.719322990126939%\" valign=\"top\"\u003e\n \u003cp\u003e3\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"8.039492242595205%\" valign=\"top\"\u003e\n \u003cp\u003e3\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"13.258110014104373%\" valign=\"top\"\u003e\n \u003cp\u003e-\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"11.988716502115656%\" valign=\"top\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"11.988716502115656%\" valign=\"top\"\u003e\n \u003cp\u003e-\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"17.348377997179124%\" valign=\"top\"\u003e\n \u003cp\u003eMultiorgan failure\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"9.30888575458392%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cstrong\u003e8.\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"17.348377997179124%\" valign=\"top\"\u003e\n \u003cp\u003eAortic valve and aortic hypoplasia+ VSD\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"10.719322990126939%\" valign=\"top\"\u003e\n \u003cp\u003e13\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"8.039492242595205%\" valign=\"top\"\u003e\n \u003cp\u003e3,5\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"13.258110014104373%\" valign=\"top\"\u003e\n \u003cp\u003eBand revision\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"11.988716502115656%\" valign=\"top\"\u003e\n \u003cp\u003e4\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"11.988716502115656%\" valign=\"top\"\u003e\n \u003cp\u003eBand release\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"17.348377997179124%\" valign=\"top\"\u003e\n \u003cp\u003e-\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"9.30888575458392%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cstrong\u003e9.\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"17.348377997179124%\" valign=\"top\"\u003e\n \u003cp\u003eTGA+right ventricle and arch hypoplasia\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"10.719322990126939%\" valign=\"top\"\u003e\n \u003cp\u003e4\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"8.039492242595205%\" valign=\"top\"\u003e\n \u003cp\u003e3,5\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"13.258110014104373%\" valign=\"top\"\u003e\n \u003cp\u003eDuctal graft and band revision\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"11.988716502115656%\" valign=\"top\"\u003e\n \u003cp\u003e7\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"11.988716502115656%\" valign=\"top\"\u003e\n \u003cp\u003eBand release\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"17.348377997179124%\" valign=\"top\"\u003e\n \u003cp\u003e-\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"9.30888575458392%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cstrong\u003e10.\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"17.348377997179124%\" valign=\"top\"\u003e\n \u003cp\u003eHLHS\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"10.719322990126939%\" valign=\"top\"\u003e\n \u003cp\u003e5\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"8.039492242595205%\" valign=\"top\"\u003e\n \u003cp\u003e3,1\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"13.258110014104373%\" valign=\"top\"\u003e\n \u003cp\u003e-\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"11.988716502115656%\" valign=\"top\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"11.988716502115656%\" valign=\"top\"\u003e\n \u003cp\u003e-\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"17.348377997179124%\" valign=\"top\"\u003e\n \u003cp\u003eSudden death at home\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"9.30888575458392%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cstrong\u003e11.\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"17.348377997179124%\" valign=\"top\"\u003e\n \u003cp\u003eAortic interruption+VSD\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"10.719322990126939%\" valign=\"top\"\u003e\n \u003cp\u003e22\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"8.039492242595205%\" valign=\"top\"\u003e\n \u003cp\u003e2,1\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"13.258110014104373%\" valign=\"top\"\u003e\n \u003cp\u003eInterruption Repair, VSD closure and debanding\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"11.988716502115656%\" valign=\"top\"\u003e\n \u003cp\u003e5\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"11.988716502115656%\" valign=\"top\"\u003e\n \u003cp\u003e-\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"17.348377997179124%\" valign=\"top\"\u003e\n \u003cp\u003e-\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"9.30888575458392%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cstrong\u003e12.\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"17.348377997179124%\" valign=\"top\"\u003e\n \u003cp\u003eHLHS\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"10.719322990126939%\" valign=\"top\"\u003e\n \u003cp\u003e12\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"8.039492242595205%\" valign=\"top\"\u003e\n \u003cp\u003e3\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"13.258110014104373%\" valign=\"top\"\u003e\n \u003cp\u003eGlenn\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"11.988716502115656%\" valign=\"top\"\u003e\n \u003cp\u003e10\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"11.988716502115656%\" valign=\"top\"\u003e\n \u003cp\u003eDuctal graft and band revision\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"17.348377997179124%\" valign=\"top\"\u003e\n \u003cp\u003e-\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"9.30888575458392%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cstrong\u003e13.\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"17.348377997179124%\" valign=\"top\"\u003e\n \u003cp\u003eAS+MS+arch hypoplasia\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"10.719322990126939%\" valign=\"top\"\u003e\n \u003cp\u003e10\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"8.039492242595205%\" valign=\"top\"\u003e\n \u003cp\u003e3\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"13.258110014104373%\" valign=\"top\"\u003e\n \u003cp\u003eCoarctation Repair, debanding\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"11.988716502115656%\" valign=\"top\"\u003e\n \u003cp\u003e2,5\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"11.988716502115656%\" valign=\"top\"\u003e\n \u003cp\u003e-\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"17.348377997179124%\" valign=\"top\"\u003e\n \u003cp\u003e-\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"9.30888575458392%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cstrong\u003e14.\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"17.348377997179124%\" valign=\"top\"\u003e\n \u003cp\u003eAS+MS+arch hypoplasia\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"10.719322990126939%\" valign=\"top\"\u003e\n \u003cp\u003e1\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"8.039492242595205%\" valign=\"top\"\u003e\n \u003cp\u003e2,6\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"13.258110014104373%\" valign=\"top\"\u003e\n \u003cp\u003e-\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"11.988716502115656%\" valign=\"top\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"11.988716502115656%\" valign=\"top\"\u003e\n \u003cp\u003e-\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"17.348377997179124%\" valign=\"top\"\u003e\n \u003cp\u003e\u0026nbsp;Sepsis \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp;(candida)\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003c/tbody\u003e\n\u003c/table\u003e\n\u003cp\u003eAS: aortic stenosis, HLHS: hypoplastic left heart syndrome, MS: mitral stenosis, TGA: transposition of great arteries, VSD: ventricular septal defect\u003c/p\u003e\n\u003cp\u003e\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eTable 2. Patient Characteristics, Surgical Data, Subsequent Operations, and Mortality Outcomes\u003c/p\u003e\n\u003ctable border=\"1\" cellspacing=\"0\" cellpadding=\"0\" width=\"604\"\u003e\n \u003ctbody\u003e\n \u003ctr\u003e\n \u003ctd width=\"50%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cstrong\u003eDemographic Data\u003c/strong\u003e\u003c/p\u003e\n \u003cp\u003eMale Gender\u003c/p\u003e\n \u003cp\u003eOperation Age (days)\u003c/p\u003e\n \u003cp\u003eWeight (kg)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"50%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cstrong\u003e\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n \u003cp\u003e10 (72 %)\u003c/p\u003e\n \u003cp\u003e8\u0026plusmn;5; 8 (1-28)\u003c/p\u003e\n \u003cp\u003e3\u0026nbsp;\u0026plusmn; 0.5\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"50%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cstrong\u003eOperative Data\u003c/strong\u003e\u003c/p\u003e\n \u003cp\u003eCPB (min)\u003c/p\u003e\n \u003cp\u003eCross-clamp time (min)\u003c/p\u003e\n \u003cp\u003eSelective perfusion (min)\u003c/p\u003e\n \u003cp\u003eHypothermia (\u0026deg;C)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"50%\" valign=\"top\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e101\u0026nbsp;\u0026plusmn;28\u003c/p\u003e\n \u003cp\u003e51\u0026nbsp;\u0026plusmn;15\u003c/p\u003e\n \u003cp\u003e53\u0026nbsp;\u0026plusmn;12\u003c/p\u003e\n \u003cp\u003e18.7\u0026nbsp;\u0026plusmn;2.2\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"50%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cstrong\u003ePostoperative Data\u003c/strong\u003e\u003c/p\u003e\n \u003cp\u003e\u003cstrong\u003eIntubation (days)\u003c/strong\u003e\u003c/p\u003e\n \u003cp\u003e\u003cstrong\u003ePeritoneal dialysis\u003c/strong\u003e\u003c/p\u003e\n \u003cp\u003e\u003cstrong\u003eECMO\u003c/strong\u003e\u003c/p\u003e\n \u003cp\u003e\u003cstrong\u003eICU stay (days)\u003c/strong\u003e\u003c/p\u003e\n \u003cp\u003e\u003cstrong\u003eHospital stay (days)\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"50%\" valign=\"top\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e14\u0026nbsp;\u0026plusmn;5\u003c/p\u003e\n \u003cp\u003e9 (64 %)\u003c/p\u003e\n \u003cp\u003e2 (14 %)\u003c/p\u003e\n \u003cp\u003e15\u0026plusmn;5\u003c/p\u003e\n \u003cp\u003e22\u0026plusmn;8\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"50%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cstrong\u003eSecond Operation\u003c/strong\u003e\u003c/p\u003e\n \u003cp\u003e\u003cstrong\u003eComplete repair\u003c/strong\u003e\u003c/p\u003e\n \u003cp\u003e\u003cstrong\u003eGlenn and/or ductal graft and/or band revision\u003c/strong\u003e\u003c/p\u003e\n \u003cp\u003e\u003cstrong\u003eThird Operation\u003c/strong\u003e\u003c/p\u003e\n \u003cp\u003e\u003cstrong\u003eDuctal graft and/or band revision\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"50%\" valign=\"top\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e2 (14 %)\u003c/p\u003e\n \u003cp\u003e5 (35%)\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e3 (21%)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"50%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cstrong\u003eMortality\u003c/strong\u003e\u003c/p\u003e\n \u003cp\u003e\u003cstrong\u003eDuring the first operation\u003c/strong\u003e\u003c/p\u003e\n \u003cp\u003e\u003cstrong\u003eAfter the first operation, at home\u003c/strong\u003e\u003c/p\u003e\n \u003cp\u003e\u003cstrong\u003eAt the second operation\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"50%\" valign=\"top\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e5 (35%)\u003c/p\u003e\n \u003cp\u003e2 (14%)\u003c/p\u003e\n \u003cp\u003e2 (14%)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003c/tbody\u003e\n\u003c/table\u003e"}],"fulltextSource":"","fullText":"","funders":[],"hasAdminPriorityOnWorkflow":false,"hasManuscriptDocX":true,"hasOptedInToPreprint":true,"hasPassedJournalQc":"","hasAnyPriority":false,"hideJournal":false,"highlight":"","institution":"","isAcceptedByJournal":true,"isAuthorSuppliedPdf":false,"isDeskRejected":"","isHiddenFromSearch":false,"isInQc":false,"isInWorkflow":false,"isPdf":false,"isPdfUpToDate":true,"isWithdrawnOrRetracted":false,"journal":{"display":true,"email":"[email protected]","identity":"pediatric-cardiology","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"pedc","sideBox":"Learn more about [Pediatric Cardiology](http://link.springer.com/journal/246)","snPcode":"246","submissionUrl":"https://submission.nature.com/new-submission/246/3","title":"Pediatric Cardiology","twitterHandle":"","acdcEnabled":true,"dfaEnabled":true,"editorialSystem":"em","reportingPortfolio":"Springer Hybrid","inReviewEnabled":true,"inReviewRevisionsEnabled":false},"keywords":"Ductal graft, Hypoplastic left heart syndrome, Modified Norwood procedure","lastPublishedDoi":"10.21203/rs.3.rs-4700683/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-4700683/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003ch2\u003eObjectives\u003c/h2\u003e \u003cp\u003eThis study evaluates a novel surgical technique inspired by the hybrid Norwood procedure, which involves ductal graft placement and bilateral pulmonary artery banding. This technique is designed to avoid the high risk classical Norwood stage 1 operation and to avoid the need for first stage invasive catheter interventions and interstage catheter interventions when ductal stent placement is not feasible in developing countries with limited resources.\u003c/p\u003e\u003ch2\u003eMethods\u003c/h2\u003e \u003cp\u003eBetween June 2015 and December 2022, 14 patients with hypoplastic left heart syndrome and variants were treated using this procedure at our center. Polytetrafluoroethylene graft was used for ductal graft procedure and polytetrafluoroethylene bands were used for bilateral pulmonary banding. Atrial septectomy was done selectively. Patients with adequate left heart growth underwent biventricular repair and pulmonary debanding. Patients without left heart growth underwent cavopulmonary anastomosis or necessary intermediate surgical revisions.\u003c/p\u003e\u003ch2\u003eResults\u003c/h2\u003e \u003cp\u003eSeven patients out of 14 reached the second stage. Two received biventricular repair, three underwent bidirectional cavopulmonary anastomosis, and two required repeat palliations other than bidirectional cavopulmonary anastomosis.\u003c/p\u003e\u003ch2\u003eConclusions\u003c/h2\u003e \u003cp\u003eModifications of the Norwood procedure is an ongoing process due to the complex nature of hypoplastic left heart syndrome and variants. As experience grows, the mortality associated with ductal graft and bilateral pulmonary banding procedure may decrease, making this technique an alternative for centers where classical Norwood operation or hybrid palliation is not possible, especially in developing countries with limited resources. We might predict promising outcomes, especially for patients with hypoplastic left heart complex where biventricular repair is expected.\u003c/p\u003e","manuscriptTitle":"Short and mid-term outcomes of ductal graft with bilateral pulmonary banding in hypoplastic left heart syndrome and variants","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2024-08-09 18:01:56","doi":"10.21203/rs.3.rs-4700683/v1","editorialEvents":[{"type":"communityComments","content":0},{"type":"decision","content":"Revision 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