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Nicholas Fitzgerald, Paul Adams, Jonathan Mervis, Annabel Webb, and 2 more This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-4088296/v1 This work is licensed under a CC BY 4.0 License Status: Published Journal Publication published 01 Aug, 2024 Read the published version in Heart, Lung and Circulation → Version 1 posted You are reading this latest preprint version Abstract Background : Ductal stenting (DS) is an alternative to the Blalock-Taussig-Thomas Shunt (BTTS) as initial palliation for congenital heart disease with duct dependent pulmonary blood flow (DDBPF). We sought to analyse the impact of intended single ventricle (SV) and biventricular (BiV) repair pathways on the outcome of DS and BTTS in infants with DDPBF. Methods : A single-centre, retrospective comparison of infants with DDPBF who underwent either DS (2012-2022) or BTTS procedures (2013-2017). Primary outcomes included all-cause mortality and risk of unplanned re-intervention. Participants were divided into four groups: 1.SV with DS, 2.SV with BTTS, 3.BiV with DS and 4.BiV with BTTS. Results : Fifty-one DS (SV 45%) and 86 BTTS (SV 49%) procedures were undertaken. For those who had DS, mortality was lower in the BiV compared to SV patients (BiV: 0/28, versus SV: 4/23, P=0.04). Compared to BiV DS, BiV BTTS had a higher risk of combined death or unplanned re-intervention (HR 4.28; CI 1.25-14.60; p=0.02). In SV participants, there was no difference for either primary outcome based on procedure type. DS was associated with shorter intensive care length of stay for SV participants (mean difference 5 days, P=0.01) and shorter intensive care and hospital stay for BiV participants (mean difference 11 days for both outcomes, P=0.001). Conclusions : There is a survival benefit for DS in BiV participants compared with DS in SV and BTTS in BiV participants. Ductal stenting is associated with a shorter intensive care and hospital length of stay. Duct-dependent pulmonary blood flow (DDPBF) Single ventricle Patent ductus arteriosus (PDA) Catheter intervention Ductal Stent Blalock-Taussig-Thomas Shunt Figures Figure 1 Key Messages What is already known on this topic: Infants with congenital heart disease and duct dependent pulmonary blood flow (DDPBF) require an initial palliative procedure to secure a source of pulmonary blood flow. Catheter intervention for ductal stent (DS) angioplasty is an accepted alternative to a surgical systemic to pulmonary artery shunt for infants with DDPBF. DS procedures are associated with a lower risk of mortality and shorter intensive care and hospital length of stay but higher rate of un-planned re-intervention. The impact of intended single and biventricular repair pathways on outcomes has been incompletely described. What this study adds: In patients with DDPBF who ultimately undergo a biventricular repair, initial palliation with DS confers a survival benefit when compared to surgical shunts for the same group of patients. There is a survival benefit for biventricular participants undergoing a ductal stent procedure compared to single ventricle participants undergoing DS. For single ventricle participants, there was no difference in mortality risk or rate of unplanned reintervention based on palliative procedure type. When compared to a surgical shunt procedure, ductal stent procedures were associated with a shorter intensive care and hospital length of stay. Introduction Congenital heart disease associated with duct dependent pulmonary blood flow (DDPBF) requires an initial palliative procedure to provide a secure source of pulmonary blood flow. Historically, this was achieved with a Blalock-Taussig-Thomas Shunt (BTTS), where a surgical graft was connected from a systemic to pulmonary artery [ 1 ]. A cardiac catheter-based intervention for ductal stent (DS) angioplasty has been developed as a minimally invasive alternative to a BTTS [ 2 , 3 ]. In two meta-analyses, DS has been shown to be associated with a lower risk of mortality and shorter hospital length of stay but a higher risk of un-planned re-intervention when compared with BTTS [ 4 , 5 ]. However, the impact of intended single ventricle (SV) versus biventricular (BiV) pathway on comparative outcomes between DS and BTTS has been incompletely described. From 2017 there was a change in practice at The Children’s Hospital at Westmead in Sydney for the initial palliative management of DDPBF lesions, from a surgical shunt to nearly exclusive use of ductal stenting. Over this time, there were minimal other changes to periprocedural and inter-stage care. In this context, we sought to analyse the impact of intended SV versus BiV pathways on both DS and BTTS outcomes. We hypothesised that SV patients would have similar outcomes after either DS or BTTS, whereas BiV patients would have more favourable outcomes after DS. Methods A single centre, retrospective cohort study was performed at The Children’s Hospital at Westmead in Sydney, Australia. Patients were divided into four groups: 1.SV with DS, 2.SV with BTTS, 3.BiV with DS and 4.BiV with BTTS. For the DS groups, the cardiac catheter database was reviewed for all patients with a DDPBF lesion who, on an intention to treat basis, underwent a DS angioplasty over a 10-year period (September 1, 2012, to August 31, 2022). Participants were excluded if they underwent DS for an isolated disconnected branch pulmonary artery. For the BTTS group, patients who underwent a surgical systemic to pulmonary artery shunt procedure over the five-year period prior to the institutional change in practice toward DS (January 1, 2013, to December 31, 2017) were identified from the cardiac surgical database. Most operations were performed in newborns (< 1 month old) although patients who had ductal patency maintained with prostaglandin beyond the newborn period were included in the study if they underwent the surgical procedure at less than three months of age. Informed consent was waived. Institutional Review Board approval was obtained for this study (HREC:2023/ETH00182). The DS procedures were performed by three interventional cardiologists over the study period. There was no standardised procedural protocol, and the strategy was tailored to the anatomy and ductal morphology. All cases used biplane fluoroscopy. The most common approach included arterial vascular access via the femoral or axillary artery. The arterial duct was crossed from the aorta with a coronary wire and a pre-mounted stent (between 3 and 5 mm in diameter) was deployed. Available stents included the Prokinetic Energy Stent and Resolute Onyx Drug Eluting Stent. A long delivery sheath was only used in select cases where the vascular access was the femoral artery, based on ductal anatomy and proceduralist’s preference. Primary outcomes were all cause mortality prior to next surgical intervention and unplanned re-intervention to treat central cyanosis. Secondary outcomes included procedural success (successful stent insertion), duration of intensive care unit (ICU) admission, total hospital length of stay (LOS), planned re-intervention rate and completion of definitive surgical repair. Patients were followed up until definitive surgical intervention (complete anatomical repair or stage two palliation surgery) or to last outpatient follow up if definitive intervention was pending, deferred, or no longer planned. All statistical analysis was conducted in R (v. 4.3.1). For the descriptive statistics, continuous variables were presented as means with standard deviation or medians with interquartile ranges and categorical variables as frequencies with percentages. For the initial analysis, differences in the baseline characteristics between DS groups (SV or BiV) and between the palliative procedure type (DS versus BTTS) were identified using two-sample t-tests and chi-squared tests of association. The same method was used to identify differences in outcomes between the four participant groups (SV with DS, SV with BTTS, BiV with DS and BiV with BTTS). Risk of death / unplanned re-intervention for cyanosis was compared between the groups using a Cox proportional hazards model. For all analyses, statistical significance was set at p < 0.05. Results Ductal Stent outcomes Fifty-one participants underwent DS during the ten-year study period (23 in the SV group and 28 in the BiV group). From September 2012 to December 2016, 8 DS procedures were undertaken whereas from January 2017 to August 2022, 43 participants had a DS. Pre-procedure assessment and procedural details of DS are outlined in Supplementary Table 1. There was no difference in the mean Stent diameter between SV and BiV participants (4.2±0.37 mm and 4.2±0.46 mm; p = 0.82). Baseline characteristics of DS patients who underwent SV versus BiV palliation were similar except those stratified to a BiV pathway were more likely to have pulmonary atresia with a ventricular septal defect or Tetralogy of Fallot (Table 1 ). Table 1 Baseline characteristics for ductal stent participants (according to intended single or biventricular destination) and by type of palliative procedure. Ductal stent participants Type of palliative procedure Intended single ventricle pathway Intended biventricular pathway p-value Ductal stent BTT shunt p-value Total number 23 28 51 86 Male (%) 8 (34.7%) 8 (28.6%) 0.764 16 (31.4%) 40 (46.5%) 0.118 Gestational age (weeks), mean (SD) 38.1 (2.0) 38.1 (1.7) 0.964 38.1 (1.8) 37.9 (2.1) 0.499 Prematurity (≤ 36 weeks, %) 3 (13.0%) 4 (14.3%) 0.687 7 (13.7%) 13 (15.1%) 0.999 Birth weight (kg), mean (SD) 3.22 (0.57) 3.02 (0.59) 0.235 3.11 (0.58) 2.86 (0.64) 0.022 Chromosome abnormality or syndrome (%) 1 (4.3%) 4 (14.3%) 0.162 5 (9.8%) 16 (18.6%) 0.418 Age (days) at procedure, mean (SD) 13.3 (18.3) 10.9 (17.4) 0.637 12.0 (17.7) 15.1 (21.8) 0.374 Weight (g) at procedure, mean (SD) 3395.2 (571.4) 3175.5 (559.4) 0.173 3274.6 (570.0) 2947.7 (744.1) 0.008 Anatomy (N,%) < 0.001 0.008 PA/VSD 0 (0%) 16 (57.1%) 16 (31.4%) 22 (26.2%) PA/IVS 6 (26.1%) 2 (7.1%) 8 (15.7%) 19 (22.6%) Tetralogy or PS/VSD 0 (0%) 7 (25.0%) 7 (13.7%) 18 (21.4%) PS/IVS 5 (21.7%) 2 (7.1%) 7 (13.7%) 0 (0%) Other 12 (52.2%) 1 (3.6%) 13 (25.5%) 25 (29.8%) Intention of 1V versus 2V (%:%) 23 (45.1%): 28 (54.9%) 44 (51.1%): 42 (48.9%) 0.596 PA = pulmonary atresia; IVS = intact ventricular septum; VSD = ventricular septal defect; 1V = single ventricle pathway; 2V = biventricular pathway The outcomes for DS participants based on intended SV or BiV pathway are outlined in Table 2 . After ductal stenting, there was a significantly higher all-cause mortality rate in the SV group compared with BiV group (4/23 versus 0/28, all within 30 days of the intervention). There was no difference in the rates of procedural failure, ICU or hospital LOS, un-planned or planned re-intervention between the DS groups. Table 2 Outcomes for ductal stent participants related to intended single or biventricular pathway. Single Ventricle (n = 23) Biventricular (n = 28) P value Procedural failure 4 (17.4%) 1 (3.6%) 0.167 ICU LOS, median (IQR) 7 (2, 12) 7 (5, 15) 0.416 Hospital LOS, median (IQR) 11 (5, 19) 9 (6, 21) 0.977 Death (Overall) 4 (17.4%)* 0 (0%) 0.035 Death 30 days 0 (0%) 0 (0%) 0.999 Reintervention (unplanned) 1 (4.3%) 3 (10.7%) 0.617 Reintervention (planned) 3 (13.0%) 3 (10.7%) 0.999 Multiple re-intervention 0 (0%) 0 (0%) 0.999 Achieved BCPC 17 (73.9%) - - Achieved biventricular circulation - 27 (96.4%) - * The causes of death included: (1) multi-organ failure on VA-ECMO, (2) haemorrhagic cerebrovascular accident two days post intervention, (3) sudden unanticipated death with right ventricular dependent coronary circulation, (4) out of hospital cardiac arrest, suspected aspiration event. BCPC = bidirectional cavo-pulmonary circulation; ICU = intensive care unit; LOS = length of stay. There were six planned re-interventions which occurred between 70 and 152 days after the initial DS procedure. These included four diagnostic catheter procedures done prior to the next surgical intervention (the existing stent was opportunistically dilated in two of these procedures). One procedure was performed to dilate a proximal right pulmonary artery stenosis through the side strut of the Stent and another to augment pulmonary blood flow with a right ventricular outflow tract stent. There was one unplanned re-intervention in the SV group and three in the BiV group. All four unplanned re-interventions were to address acute or progressive desaturation related to reduced pulmonary blood flow and occurred between 3 and 92 days following the initial procedure. The problem related to either inadequate ductal coverage with the Stent or in-Stent stenosis. During three of the unplanned re-intervention procedures, a new ductal Stent was deployed. In the fourth procedure, there was a cardiac arrest during balloon angioplasty of the existing Stent which required establishment of extra-corporeal membrane oxygenation. At the completion of the study period, 17/23 participants in the SV group had undergone the next stage intervention (all surgeries were a bidirectional cavo-pulmonary connection), 4/23 had died and 2/23 were alive but had not yet reached the surgical repair stage. In the BiV group, 27/28 participants had undergone complete repair and 1/28 was alive and awaiting repair. Ductal Stent compared with surgical shunt outcomes. Eighty-six participants underwent a BTTS during the five-year period between 2013 and 2017 (44 in the SV group and 42 in the BiV group). The baseline characteristics of DS versus BTTS patients are shown in Table 1 . BTTS participants had a lower birth weight and procedural weight compared to DS participants. There were minor differences in the underlying cardiac diagnosis, but a similar proportion were planned for SV and BiV pathways. Outcomes based upon type of initial palliation for those intending to follow a SV pathway are shown in Table 3 . Participants receiving DS had a shorter median length of ICU LOS (7 days versus 12 days, P = 0.008) but the other outcomes were similar compared to SV patients receiving a BTTS. Outcomes based upon type of palliation for those intending to follow a BiV pathway are shown in Table 4 . Patients receiving a DS had a significantly shorter median length of ICU (9 days versus 20 days, P = 0.011) and overall hospital LOS (9 days versus 20 days, P = 0.011) but no difference in other outcomes compared to BiV patients receiving a BTTS. Table 3 Outcomes for patients with intended single repair pathway related to palliative procedure. Ductal Stent, n = 23 BT Shunt, n = 44 P value Procedural failure 4 (17.4%) - - ICU LOS, median (IQR) 7 (2, 12) 12 (7, 17) 0.008 Hospital LOS, median (IQR) 11 (5, 19) 14 (9, 23) 0.090 Death (Overall), (N,%) 4 (17.4%) 7 (15.9%) 0.999 Death 30 days 0 (0%) 3 (6.8%) 0.546 1st Reintervention (unplanned) 1 (4.3%) 7 (15.9%) 0.247 1st Reintervention (planned) 3 (13.0%) 6 (13.6%) 0.999 Multiple re-intervention (N,%) 0 (0%) 5 (11.4%) 0.161 ICU = intensive care unit; LOS = length of stay. Table 4 Outcomes for patients with intended biventricular repair pathway related to palliative procedure. Ductal Stent, n = 28 BT Shunt, n = 42 P value Procedural failure 1 (3.6%) - - ICU LOS, median (IQR) 7 (5, 15) 17 (7, 30) 0.030 Hospital LOS, median (IQR) 9 (6, 21) 20 (11, 40) 0.011 Death (Overall), (N,%) 0 (0%) 5 (11.9%) 0.149 Death 30 days 0 (0%) 3 (7.1%) 0.275 1st Reintervention (unplanned) 3 (10.7%) 12 (28.6%) 0.078 1st Reintervention (planned) 3 (10.7%) 5 (11.9%) 0.715 Multiple re-intervention (N,%) 0 (0%) 4 (9.5%) 0.141 ICU = intensive care unit; LOS = length of stay. The risks of death and/or unplanned re-intervention between the four groups are shown in Table 5 . The BiV BTTS group had a significantly increased risk of death and or unplanned re-intervention compared to BiV DS participants (HR 4.28; CI 1.25–14.6; p = 0.02). Time to unplanned re-intervention or death was similar in the SV group regardless of DS or BTTS. Kaplan Meir curves showing time to death (Fig. 1 a) and time to unplanned reintervention (Fig. 1 b) highlight a survival advantage for BiV patients undergoing DS. Table 5 Cox proportional hazards model for time to unplanned re-intervention or death. Time to unplanned reintervention, death as competing risk Time to death Time to unplanned re-intervention or death HR (95% CI) p-value HR (95% CI) p-value HR (95% CI) p-value BTTS SV vs. DS SV 3.22 (0.40, 25.74) 0.271 0.74 (0.22, 2.55) 0.639 1.10 (0.39, 3.13) 0.853 BTTS SV vs. BTTS BiV 1.92 (0.77, 4.78) 0.160 0.69 (0.22, 2.18) 0.531 1.59 (0.76, 3.33) 0.222 BTTS BiV vs. DS BiV 3.00 (0.89, 10.16) 0.078 NA* - 4.28 (1.25, 14.61) 0.023 DS SV vs. DS BiV 0.50 (0.05, 4.75) 0.549 NA* - 2.57 (0.61, 10.79) 0.196 BTTS = Blalock-Taussig-Thomas shunt; DS = ductal stent; SV = single ventricle; BiV = biventricular; NA* = comparison not possible as no deaths occurred in the DS BiV group Discussion In this study, we specifically examined the impact of intended SV and BiV repair pathways on the outcome of DS and BTTS procedures in infants with DDPBF. Our principle findings were that: i) in BiV patients, death or unplanned reintervention is lower after DS than BTTS, ii) length of ICU and/or overall hospital LOS is lower after DS than BTTS and iii) in SV patients, risk of death or unplanned reintervention is similar after DS and BTTS. Impact of DS versus BTTS palliation on survival and unplanned re-intervention in SV physiology. A recent meta-analysis found an equivalent 30-day mortality after DS and BTTS, lower medium-term mortality after DS (HR = 0.6; CI = 0.4–0.99; p = 0.05) and increased risk of unplanned re-interventions after DS (HR = 1.77; CI = 1.39–2.26; p < 0.01) [ 4 ]. The larger studies comparing DS and BTTS have included substantial numbers of patients with intended SV pathway. Glatz et al. [ 6 ], in a multi-centre US study comparing 106 infants undergoing DS (60% BiV) versus 251 with BTTS (45% BiV), accounted for SV physiology amongst other baseline factors, by propensity score adjustment. These authors found no difference in death or unplanned re-interventions to treat cyanosis between the groups. In contrast, Bentham et al. [ 7 ], in a multi-centre UK study of 83 infants undergoing DS (53% BiV) versus 171 with a BTTS (43% BiV), found lower mortality in the DS group after propensity score adjustment for baseline factors including SV status. Few studies have specifically compared DS and BTTS outcomes for SV versus BiV patients with conflicting results. For example, Meadows et al [ 8 ]. reported on 171 SV infants with duct dependent pulmonary blood flow (n = 136 receiving BTTS and n = 35 receiving DS). Interstage mortality and unplanned reintervention did not differ between the groups. In contrast, Prabhu et al [ 9 ], reporting outcomes in SV infants after DS (n = 11) and BTTS (n = 23), found a higher proportion of survival to stage II surgery after DS (100% versus 64%, p = 0.035). Our data contributes to the evidence that interstage mortality and unplanned re-interventions are similar after DS and BTTS in SV patients. The choice of initial palliation may depend upon other short and long term benefits of one or other strategy. This is in contrast with infants with a BiV circulation, where DS appears to convey clear survival advantages. Impact of DS versus BTTS palliation on length of stay and costs of intervention. Numerous studies, including ours, have shown shorter ICU and hospital LOS after DS compared to BTTS [ 6 , 10 ]. In a recent report utilizing data from the Pediatric Health Information System of infants undergoing DS and BTTS between January 2016 and December 2021, DS was associated with 11 days shorter post-intervention hospital length of stay (95% CI 7.2–14.8; p < 0.001) but with higher 3- and 6-month reintervention rates [ 11 ]. The overall costs related to the index hospitalization were significantly lower after DS than BTTS ( $ 120 400 versus $ 198 300, p < 0.001), although these costs did not include those related to reintervention. The overall health care costs of SV care are high [ 12 , 13 ] and whether DS palliation has any impact on these costs remain to be determined. Impact of DS versus BTTS palliation on pulmonary artery growth The data on the benefits of either DS or BTTS palliation on pulmonary artery development remain varied. For example, in the mixed cohort reported by Bentham et al. [ 7 ], pulmonary artery size prior to the next stage was similar but the need for pulmonary artery augmentation was greater after DS. In contrast, Glatz et al. [ 6 ] showed larger and more symmetrical pulmonary arteries after DS compared to BTTS at the time of subsequent surgical repair or at last follow-up. In the study of SV patients, Meadows et al. [ 8 ], found similar pulmonary artery growth and pre-stage II cardiac catheterization haemodynamic findings after DS and BTTS. Examination of pulmonary artery growth was beyond the scope of our current study but remains an area of interest. Limitations This study was limited by its retrospective nature and small sample size. It encompasses the entire clinical experience with DS procedures at a single institute and therefore may be subject to institutional practice that limit the applicability of the data more broadly. With near exclusive DS from 2017, there was a learning curve effect for the interventionalists as the case/procedural complexity increased which may have impacted the results related to DS. The same learning curve was clearly not present for BTTS. As there were no deaths in the BiV DS group we were unable to determine the risk of mortality in this group separately to unplanned re-intervention. Conclusion This study demonstrated a combined survival/unplanned re-intervention benefit for BiV participants undergoing DS compared to DS in SV participants and BTTS in BiV participants. There was no difference in the outcomes between SV participants based on procedure type. Regardless of intended SV or BiV pathway, DS procedures had an advantage compared with BTTS for ICU and hospital LOS. Ultimately, DS compared to BTTS is not an inferior approach to stage one palliation for DDPBF lesions with a clear mortality benefit in BiV patients and shorter hospital LOS in both SV and BiV pathways. Declarations Author Contribution The authors confirm contribution to the paper as follows: study conception and design: N.F, P.A, J.M, P.R and J.A; review board/ethics application: N.F and J.A; data collection: N.F; analysis and interpretation of results: N.F, A.W and J.A; draft manuscript preparation: N.F; progress review of manuscript: J.M, P.R and J.A. 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Circulation: Cardiovasc Interv 14:e009520. 10.1161/circinterventions.120.009520 Valencia E, Staffa S, Kuntz M, Zaleski K, Kaza A, Maschietto et al (2023) Transcatheter ductal stents versus surgical systemic-pulmonary artery shunts in neonates with congenital heart disease with ductal-dependent pulmonary blood flow: trends and associated outcomes from the Pediatric Health Information System Database. J Am Heart Assoc 12(17):e030528. 10.1161/JAHA.123.030528 Huang L, Schilling C, Dalziel K, Xie S, Celermajer D, McNeil J et al (2017) Hospital inpatient costs for single ventricle patients surviving the Fontan procedure. Am J Cardiol 120(3):467–472. 10.1016/j.amjcard.2017.04.049 O’Byrne M, McHugh K, Huang J, Song L, Griffis H, Anderson B et al (2022) Cumulative in-hospital costs associated with single-ventricle palliation. JACC Adv 1(2). https://doi.org/10.1016/j.jacadv.2022.100029 Additional Declarations No competing interests reported. Supplementary Files SUPPLEMENTARYTABLE.docx Cite Share Download PDF Status: Published Journal Publication published 01 Aug, 2024 Read the published version in Heart, Lung and Circulation → Version 1 posted 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. As a division of Research Square Company, we’re committed to making research communication faster, fairer, and more useful. We do this by developing innovative software and high quality services for the global research community. Our growing team is made up of researchers and industry professionals working together to solve the most critical problems facing scientific publishing. Also discoverable on Platform About Our Team In Review Editorial Policies Advisory Board Help Center Resources Author Services Accessibility API Access RSS feed Manage Cookie Preferences © Research Square 2026 | ISSN 2693-5015 (online) Privacy Policy Terms of Service Do Not Sell My Personal Information {"props":{"pageProps":{"initialData":{"identity":"rs-4088296","acceptedTermsAndConditions":true,"allowDirectSubmit":false,"archivedVersions":[],"articleType":"Research Article","associatedPublications":[],"authors":[{"id":279244806,"identity":"bddcdd1c-429b-4ac0-a37e-af80370ce27e","order_by":0,"name":"Nicholas Fitzgerald","email":"data:image/png;base64,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","orcid":"","institution":"The Children’s Hospital at Westmead","correspondingAuthor":true,"prefix":"","firstName":"Nicholas","middleName":"","lastName":"Fitzgerald","suffix":""},{"id":279244807,"identity":"41a7a898-7007-4795-84ab-59024b3f21b6","order_by":1,"name":"Paul Adams","email":"","orcid":"","institution":"The Children’s Hospital at Westmead","correspondingAuthor":false,"prefix":"","firstName":"Paul","middleName":"","lastName":"Adams","suffix":""},{"id":279244808,"identity":"97efa969-bb75-4002-8084-ccef75279d80","order_by":2,"name":"Jonathan Mervis","email":"","orcid":"","institution":"The Children’s Hospital at Westmead","correspondingAuthor":false,"prefix":"","firstName":"Jonathan","middleName":"","lastName":"Mervis","suffix":""},{"id":279244809,"identity":"1cfdc1d5-07c3-4de5-a35e-34186f78a7f7","order_by":3,"name":"Annabel Webb","email":"","orcid":"","institution":"The University of Sydney","correspondingAuthor":false,"prefix":"","firstName":"Annabel","middleName":"","lastName":"Webb","suffix":""},{"id":279244810,"identity":"fedc2a38-efb7-42a4-8470-b207a1563e57","order_by":4,"name":"Philip Roberts","email":"","orcid":"","institution":"The Children’s Hospital at Westmead","correspondingAuthor":false,"prefix":"","firstName":"Philip","middleName":"","lastName":"Roberts","suffix":""},{"id":279244811,"identity":"c6c76395-d264-4381-bfff-bc1f135ba657","order_by":5,"name":"Julian Ayer","email":"","orcid":"","institution":"The Children’s Hospital at Westmead","correspondingAuthor":false,"prefix":"","firstName":"Julian","middleName":"","lastName":"Ayer","suffix":""}],"badges":[],"createdAt":"2024-03-13 01:45:50","currentVersionCode":1,"declarations":"","doi":"10.21203/rs.3.rs-4088296/v1","doiUrl":"https://doi.org/10.21203/rs.3.rs-4088296/v1","draftVersion":[],"editorialEvents":[{"content":"https://doi.org/10.1016/j.hlc.2024.06.791","type":"published","date":"2024-08-01T20:19:29+00:00"}],"editorialNote":"","failedWorkflow":false,"files":[{"id":52792352,"identity":"790ac119-18b8-42f1-b57c-2f7401d56a22","added_by":"auto","created_at":"2024-03-15 20:17:34","extension":"jpeg","order_by":1,"title":"Figure 1","display":"","copyAsset":false,"role":"figure","size":367526,"visible":true,"origin":"","legend":"\u003cp\u003eEvent free survival curve comparing time to death (A) and time to unplanned re-intervention (B) for ductal stent and Blalock-Taussig-Thomas shunt participants related to single or biventricular destination.\u003c/p\u003e","description":"","filename":"floatimage1.jpeg","url":"https://assets-eu.researchsquare.com/files/rs-4088296/v1/a8ce9092664056c1c00ba4f3.jpeg"},{"id":61264203,"identity":"ddc0118c-71f2-487c-bc98-f66a84cb0456","added_by":"auto","created_at":"2024-07-28 20:19:37","extension":"pdf","order_by":0,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":1019196,"visible":true,"origin":"","legend":"","description":"","filename":"manuscript.pdf","url":"https://assets-eu.researchsquare.com/files/rs-4088296/v1/b298f634-ede0-46b6-b02c-949c613b1131.pdf"},{"id":52792328,"identity":"454e0efc-07f7-4df1-b3bb-9c7913e751f0","added_by":"auto","created_at":"2024-03-15 20:17:24","extension":"docx","order_by":1,"title":"","display":"","copyAsset":false,"role":"supplement","size":15473,"visible":true,"origin":"","legend":"","description":"","filename":"SUPPLEMENTARYTABLE.docx","url":"https://assets-eu.researchsquare.com/files/rs-4088296/v1/73ab35267f695305ff19e59e.docx"}],"financialInterests":"No competing interests reported.","formattedTitle":"A comparison of ductal stenting and surgical shunts for infants with duct-dependent pulmonary blood flow; the impact of single versus biventricular repair pathways on outcomes.","fulltext":[{"header":"Key Messages","content":"\u003cp\u003eWhat is already known on this topic: \u0026nbsp;\u003c/p\u003e\n\u003cul\u003e\n \u003cli\u003eInfants with congenital heart disease and duct dependent pulmonary blood flow (DDPBF) require an initial palliative procedure to secure a source of pulmonary blood flow.\u0026nbsp;\u003c/li\u003e\n \u003cli\u003eCatheter intervention for ductal stent (DS) angioplasty is an accepted alternative to a surgical systemic to pulmonary artery shunt for infants with DDPBF.\u0026nbsp;\u003c/li\u003e\n \u003cli\u003eDS procedures are associated with a lower risk of mortality and shorter intensive care and hospital length of stay but higher rate of un-planned re-intervention.\u0026nbsp;\u003c/li\u003e\n \u003cli\u003eThe impact of intended single and biventricular repair pathways on outcomes has been incompletely described.\u0026nbsp;\u003c/li\u003e\n\u003c/ul\u003e\n\u003cp\u003eWhat this study adds:\u0026nbsp;\u003c/p\u003e\n\u003cul\u003e\n \u003cli\u003eIn patients with DDPBF who ultimately undergo a biventricular repair, initial palliation with DS confers a survival benefit when compared to surgical shunts for the same group of patients.\u003c/li\u003e\n \u003cli\u003eThere is a survival benefit for biventricular participants undergoing a ductal stent procedure compared to single ventricle participants undergoing DS.\u0026nbsp;\u003c/li\u003e\n \u003cli\u003eFor single ventricle participants, there was no difference in mortality risk or rate of unplanned reintervention based on palliative procedure type.\u003c/li\u003e\n \u003cli\u003eWhen compared to a surgical shunt procedure, ductal stent procedures were associated with a shorter intensive care and hospital length of stay.\u0026nbsp;\u003c/li\u003e\n\u003c/ul\u003e"},{"header":"Introduction","content":"\u003cp\u003eCongenital heart disease associated with duct dependent pulmonary blood flow (DDPBF) requires an initial palliative procedure to provide a secure source of pulmonary blood flow. Historically, this was achieved with a Blalock-Taussig-Thomas Shunt (BTTS), where a surgical graft was connected from a systemic to pulmonary artery [\u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e]. A cardiac catheter-based intervention for ductal stent (DS) angioplasty has been developed as a minimally invasive alternative to a BTTS [\u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e, \u003cspan citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e]. In two meta-analyses, DS has been shown to be associated with a lower risk of mortality and shorter hospital length of stay but a higher risk of un-planned re-intervention when compared with BTTS [\u003cspan citationid=\"CR4\" class=\"CitationRef\"\u003e4\u003c/span\u003e, \u003cspan citationid=\"CR5\" class=\"CitationRef\"\u003e5\u003c/span\u003e]. However, the impact of intended single ventricle (SV) versus biventricular (BiV) pathway on comparative outcomes between DS and BTTS has been incompletely described.\u003c/p\u003e \u003cp\u003eFrom 2017 there was a change in practice at The Children\u0026rsquo;s Hospital at Westmead in Sydney for the initial palliative management of DDPBF lesions, from a surgical shunt to nearly exclusive use of ductal stenting. Over this time, there were minimal other changes to periprocedural and inter-stage care. In this context, we sought to analyse the impact of intended SV versus BiV pathways on both DS and BTTS outcomes. We hypothesised that SV patients would have similar outcomes after either DS or BTTS, whereas BiV patients would have more favourable outcomes after DS.\u003c/p\u003e"},{"header":"Methods","content":"\u003cp\u003eA single centre, retrospective cohort study was performed at The Children\u0026rsquo;s Hospital at Westmead in Sydney, Australia. Patients were divided into four groups: 1.SV with DS, 2.SV with BTTS, 3.BiV with DS and 4.BiV with BTTS. For the DS groups, the cardiac catheter database was reviewed for all patients with a DDPBF lesion who, on an intention to treat basis, underwent a DS angioplasty over a 10-year period (September 1, 2012, to August 31, 2022). Participants were excluded if they underwent DS for an isolated disconnected branch pulmonary artery. For the BTTS group, patients who underwent a surgical systemic to pulmonary artery shunt procedure over the five-year period prior to the institutional change in practice toward DS (January 1, 2013, to December 31, 2017) were identified from the cardiac surgical database. Most operations were performed in newborns (\u0026lt;\u0026thinsp;1 month old) although patients who had ductal patency maintained with prostaglandin beyond the newborn period were included in the study if they underwent the surgical procedure at less than three months of age. Informed consent was waived. Institutional Review Board approval was obtained for this study (HREC:2023/ETH00182).\u003c/p\u003e \u003cp\u003eThe DS procedures were performed by three interventional cardiologists over the study period. There was no standardised procedural protocol, and the strategy was tailored to the anatomy and ductal morphology. All cases used biplane fluoroscopy. The most common approach included arterial vascular access via the femoral or axillary artery. The arterial duct was crossed from the aorta with a coronary wire and a pre-mounted stent (between 3 and 5 mm in diameter) was deployed. Available stents included the Prokinetic Energy Stent and Resolute Onyx Drug Eluting Stent. A long delivery sheath was only used in select cases where the vascular access was the femoral artery, based on ductal anatomy and proceduralist\u0026rsquo;s preference.\u003c/p\u003e \u003cp\u003ePrimary outcomes were all cause mortality prior to next surgical intervention and unplanned re-intervention to treat central cyanosis. Secondary outcomes included procedural success (successful stent insertion), duration of intensive care unit (ICU) admission, total hospital length of stay (LOS), planned re-intervention rate and completion of definitive surgical repair. Patients were followed up until definitive surgical intervention (complete anatomical repair or stage two palliation surgery) or to last outpatient follow up if definitive intervention was pending, deferred, or no longer planned.\u003c/p\u003e \u003cp\u003eAll statistical analysis was conducted in R (v. 4.3.1). For the descriptive statistics, continuous variables were presented as means with standard deviation or medians with interquartile ranges and categorical variables as frequencies with percentages. For the initial analysis, differences in the baseline characteristics between DS groups (SV or BiV) and between the palliative procedure type (DS versus BTTS) were identified using two-sample t-tests and chi-squared tests of association. The same method was used to identify differences in outcomes between the four participant groups (SV with DS, SV with BTTS, BiV with DS and BiV with BTTS). Risk of death / unplanned re-intervention for cyanosis was compared between the groups using a Cox proportional hazards model. For all analyses, statistical significance was set at p\u0026thinsp;\u0026lt;\u0026thinsp;0.05.\u003c/p\u003e"},{"header":"Results","content":"\u003cdiv id=\"Sec4\" class=\"Section2\"\u003e \u003ch2\u003eDuctal Stent outcomes\u003c/h2\u003e \u003cp\u003eFifty-one participants underwent DS during the ten-year study period (23 in the SV group and 28 in the BiV group). From September 2012 to December 2016, 8 DS procedures were undertaken whereas from January 2017 to August 2022, 43 participants had a DS. Pre-procedure assessment and procedural details of DS are outlined in Supplementary Table\u0026nbsp;1. There was no difference in the mean Stent diameter between SV and BiV participants (4.2\u0026plusmn;0.37 mm and 4.2\u0026plusmn;0.46 mm; p\u0026thinsp;=\u0026thinsp;0.82). Baseline characteristics of DS patients who underwent SV versus BiV palliation were similar except those stratified to a BiV pathway were more likely to have pulmonary atresia with a ventricular septal defect or Tetralogy of Fallot (Table\u0026nbsp;\u003cspan refid=\"Tab1\" class=\"InternalRef\"\u003e1\u003c/span\u003e).\u003c/p\u003e \u003cp\u003e \u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab1\" border=\"1\"\u003e \u003ccaption language=\"En\"\u003e \u003cdiv class=\"CaptionNumber\"\u003eTable 1\u003c/div\u003e \u003cdiv class=\"CaptionContent\"\u003e \u003cp\u003eBaseline characteristics for ductal stent participants (according to intended single or biventricular destination) and by type of palliative procedure.\u003c/p\u003e \u003c/div\u003e \u003c/caption\u003e \u003ccolgroup cols=\"7\"\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e \u003cdiv align=\"char\" char=\".\" class=\"colspec\" colname=\"c4\" colnum=\"4\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c5\" colnum=\"5\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c6\" colnum=\"6\"\u003e\u003c/div\u003e \u003cdiv align=\"char\" char=\".\" class=\"colspec\" colname=\"c7\" colnum=\"7\"\u003e\u003c/div\u003e \u003cthead\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c1\" morerows=\"1\" rowspan=\"2\"\u003e\u0026nbsp;\u003c/th\u003e \u003cth align=\"left\" colspan=\"3\" nameend=\"c4\" namest=\"c2\"\u003e \u003cp\u003eDuctal stent participants\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colspan=\"3\" nameend=\"c7\" namest=\"c5\"\u003e \u003cp\u003eType of palliative procedure\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c2\"\u003e \u003cp\u003eIntended single ventricle pathway\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c3\"\u003e \u003cp\u003eIntended biventricular pathway\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c4\"\u003e \u003cp\u003ep-value\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c5\"\u003e \u003cp\u003eDuctal stent\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c6\"\u003e \u003cp\u003eBTT shunt\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c7\"\u003e \u003cp\u003ep-value\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003c/thead\u003e \u003ctbody\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eTotal number\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e23\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e28\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e51\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e86\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eMale (%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e8 (34.7%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e8 (28.6%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e0.764\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e16 (31.4%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e40 (46.5%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c7\"\u003e \u003cp\u003e0.118\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eGestational age (weeks), mean (SD)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e38.1 (2.0)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e38.1 (1.7)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e0.964\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e38.1 (1.8)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e37.9 (2.1)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c7\"\u003e \u003cp\u003e0.499\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003ePrematurity\u003c/p\u003e \u003cp\u003e(\u0026le;\u0026thinsp;36 weeks, %)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e3 (13.0%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e4 (14.3%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e0.687\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e7 (13.7%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e13 (15.1%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c7\"\u003e \u003cp\u003e0.999\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eBirth weight (kg), mean (SD)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e3.22 (0.57)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e3.02 (0.59)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e0.235\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e3.11 (0.58)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e2.86 (0.64)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c7\"\u003e \u003cp\u003e\u003cb\u003e0.022\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eChromosome abnormality or syndrome (%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e1 (4.3%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e4 (14.3%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e0.162\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e5 (9.8%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e16 (18.6%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c7\"\u003e \u003cp\u003e0.418\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eAge (days) at procedure, mean (SD)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e13.3 (18.3)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e10.9 (17.4)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e0.637\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e12.0 (17.7)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e15.1 (21.8)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c7\"\u003e \u003cp\u003e0.374\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eWeight (g) at procedure, mean (SD)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e3395.2 (571.4)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e3175.5 (559.4)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e0.173\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e3274.6 (570.0)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e2947.7 (744.1)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c7\"\u003e \u003cp\u003e\u003cb\u003e0.008\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eAnatomy (N,%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e\u003cb\u003e\u0026lt;\u0026thinsp;0.001\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c7\"\u003e \u003cp\u003e\u003cb\u003e0.008\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003ePA/VSD\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e0 (0%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e16 (57.1%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e16 (31.4%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e22 (26.2%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003ePA/IVS\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e6 (26.1%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e2 (7.1%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e8 (15.7%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e19 (22.6%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eTetralogy or PS/VSD\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e0 (0%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e7 (25.0%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e7 (13.7%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e18 (21.4%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003ePS/IVS\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e5 (21.7%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e2 (7.1%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e7 (13.7%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e0 (0%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eOther\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e12 (52.2%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e1 (3.6%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e13 (25.5%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e25 (29.8%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eIntention of 1V versus 2V (%:%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e23 (45.1%):\u003c/p\u003e \u003cp\u003e28 (54.9%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e44 (51.1%):\u003c/p\u003e \u003cp\u003e42 (48.9%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c7\"\u003e \u003cp\u003e0.596\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003c/tbody\u003e \u003c/colgroup\u003e \u003ctfoot\u003e \u003ctr\u003e\u003ctd colspan=\"7\"\u003ePA\u0026thinsp;=\u0026thinsp;pulmonary atresia; IVS\u0026thinsp;=\u0026thinsp;intact ventricular septum; VSD\u0026thinsp;=\u0026thinsp;ventricular septal defect; 1V\u0026thinsp;=\u0026thinsp;single ventricle pathway; 2V\u0026thinsp;=\u0026thinsp;biventricular pathway\u003c/td\u003e\u003c/tr\u003e \u003c/tfoot\u003e \u003c/table\u003e\u003c/div\u003e \u003c/p\u003e \u003cp\u003eThe outcomes for DS participants based on intended SV or BiV pathway are outlined in Table\u0026nbsp;\u003cspan refid=\"Tab2\" class=\"InternalRef\"\u003e2\u003c/span\u003e. After ductal stenting, there was a significantly higher all-cause mortality rate in the SV group compared with BiV group (4/23 versus 0/28, all within 30 days of the intervention). There was no difference in the rates of procedural failure, ICU or hospital LOS, un-planned or planned re-intervention between the DS groups.\u003c/p\u003e \u003cp\u003e \u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab2\" border=\"1\"\u003e \u003ccaption language=\"En\"\u003e \u003cdiv class=\"CaptionNumber\"\u003eTable 2\u003c/div\u003e \u003cdiv class=\"CaptionContent\"\u003e \u003cp\u003eOutcomes for ductal stent participants related to intended single or biventricular pathway.\u003c/p\u003e \u003c/div\u003e \u003c/caption\u003e \u003ccolgroup cols=\"4\"\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c4\" colnum=\"4\"\u003e\u003c/div\u003e \u003cthead\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/th\u003e \u003cth align=\"left\" colname=\"c2\"\u003e \u003cp\u003eSingle Ventricle\u003c/p\u003e \u003cp\u003e(n\u0026thinsp;=\u0026thinsp;23)\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c3\"\u003e \u003cp\u003eBiventricular\u003c/p\u003e \u003cp\u003e(n\u0026thinsp;=\u0026thinsp;28)\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c4\"\u003e \u003cp\u003eP value\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003c/thead\u003e \u003ctbody\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eProcedural failure\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e4 (17.4%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e1 (3.6%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e0.167\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eICU LOS, median (IQR)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e7 (2, 12)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e7 (5, 15)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e0.416\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eHospital LOS, median (IQR)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e11 (5, 19)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e9 (6, 21)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e0.977\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eDeath (Overall)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e4 (17.4%)*\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e0 (0%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e\u003cb\u003e0.035\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eDeath\u0026thinsp;\u0026lt;\u0026thinsp;30 days\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e4 (17.4%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e0 (0%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e\u003cb\u003e0.035\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eDeath\u0026thinsp;\u0026gt;\u0026thinsp;30 days\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e0 (0%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e0 (0%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e0.999\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eReintervention (unplanned)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e1 (4.3%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e3 (10.7%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e0.617\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eReintervention (planned)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e3 (13.0%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e3 (10.7%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e0.999\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eMultiple re-intervention\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e0 (0%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e0 (0%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e0.999\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eAchieved BCPC\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e17 (73.9%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e-\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e-\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eAchieved biventricular circulation\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e-\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e27 (96.4%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e-\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003c/tbody\u003e \u003c/colgroup\u003e \u003c/table\u003e\u003c/div\u003e \u003c/p\u003e \u003cp\u003e* The causes of death included: (1) multi-organ failure on VA-ECMO, (2) haemorrhagic cerebrovascular accident two days post intervention, (3) sudden unanticipated death with right ventricular dependent coronary circulation, (4) out of hospital cardiac arrest, suspected aspiration event. BCPC\u0026thinsp;=\u0026thinsp;bidirectional cavo-pulmonary circulation; ICU\u0026thinsp;=\u0026thinsp;intensive care unit; LOS\u0026thinsp;=\u0026thinsp;length of stay.\u003c/p\u003e \u003cp\u003eThere were six planned re-interventions which occurred between 70 and 152 days after the initial DS procedure. These included four diagnostic catheter procedures done prior to the next surgical intervention (the existing stent was opportunistically dilated in two of these procedures). One procedure was performed to dilate a proximal right pulmonary artery stenosis through the side strut of the Stent and another to augment pulmonary blood flow with a right ventricular outflow tract stent. There was one unplanned re-intervention in the SV group and three in the BiV group. All four unplanned re-interventions were to address acute or progressive desaturation related to reduced pulmonary blood flow and occurred between 3 and 92 days following the initial procedure. The problem related to either inadequate ductal coverage with the Stent or in-Stent stenosis. During three of the unplanned re-intervention procedures, a new ductal Stent was deployed. In the fourth procedure, there was a cardiac arrest during balloon angioplasty of the existing Stent which required establishment of extra-corporeal membrane oxygenation.\u003c/p\u003e \u003cp\u003eAt the completion of the study period, 17/23 participants in the SV group had undergone the next stage intervention (all surgeries were a bidirectional cavo-pulmonary connection), 4/23 had died and 2/23 were alive but had not yet reached the surgical repair stage. In the BiV group, 27/28 participants had undergone complete repair and 1/28 was alive and awaiting repair.\u003c/p\u003e \u003cp\u003e \u003cb\u003eDuctal Stent compared with surgical shunt outcomes.\u003c/b\u003e \u003c/p\u003e \u003cp\u003eEighty-six participants underwent a BTTS during the five-year period between 2013 and 2017 (44 in the SV group and 42 in the BiV group). The baseline characteristics of DS versus BTTS patients are shown in Table\u0026nbsp;\u003cspan refid=\"Tab1\" class=\"InternalRef\"\u003e1\u003c/span\u003e. BTTS participants had a lower birth weight and procedural weight compared to DS participants. There were minor differences in the underlying cardiac diagnosis, but a similar proportion were planned for SV and BiV pathways.\u003c/p\u003e \u003cp\u003eOutcomes based upon type of initial palliation for those intending to follow a SV pathway are shown in Table\u0026nbsp;\u003cspan refid=\"Tab3\" class=\"InternalRef\"\u003e3\u003c/span\u003e. Participants receiving DS had a shorter median length of ICU LOS (7 days versus 12 days, P\u0026thinsp;=\u0026thinsp;0.008) but the other outcomes were similar compared to SV patients receiving a BTTS. Outcomes based upon type of palliation for those intending to follow a BiV pathway are shown in Table\u0026nbsp;\u003cspan refid=\"Tab4\" class=\"InternalRef\"\u003e4\u003c/span\u003e. Patients receiving a DS had a significantly shorter median length of ICU (9 days versus 20 days, P\u0026thinsp;=\u0026thinsp;0.011) and overall hospital LOS (9 days versus 20 days, P\u0026thinsp;=\u0026thinsp;0.011) but no difference in other outcomes compared to BiV patients receiving a BTTS.\u003c/p\u003e \u003cp\u003e \u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab3\" border=\"1\"\u003e \u003ccaption language=\"En\"\u003e \u003cdiv class=\"CaptionNumber\"\u003eTable 3\u003c/div\u003e \u003cdiv class=\"CaptionContent\"\u003e \u003cp\u003eOutcomes for patients with intended single repair pathway related to palliative procedure.\u003c/p\u003e \u003c/div\u003e \u003c/caption\u003e \u003ccolgroup cols=\"4\"\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c4\" colnum=\"4\"\u003e\u003c/div\u003e \u003cthead\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/th\u003e \u003cth align=\"left\" colname=\"c2\"\u003e \u003cp\u003eDuctal Stent, n\u0026thinsp;=\u0026thinsp;23\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c3\"\u003e \u003cp\u003eBT Shunt, n\u0026thinsp;=\u0026thinsp;44\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c4\"\u003e \u003cp\u003eP value\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003c/thead\u003e \u003ctbody\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eProcedural failure\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e4 (17.4%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e-\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e-\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eICU LOS, median (IQR)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e7 (2, 12)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e12 (7, 17)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e\u003cb\u003e0.008\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eHospital LOS, median (IQR)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e11 (5, 19)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e14 (9, 23)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e0.090\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eDeath (Overall), (N,%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e4 (17.4%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e7 (15.9%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e0.999\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eDeath\u0026thinsp;\u0026lt;\u0026thinsp;30 days\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e4 (17.4%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e4 (9.1%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e0.431\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eDeath\u0026thinsp;\u0026gt;\u0026thinsp;30 days\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e0 (0%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e3 (6.8%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e0.546\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e1st Reintervention (unplanned)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e1 (4.3%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e7 (15.9%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e0.247\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e1st Reintervention (planned)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e3 (13.0%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e6 (13.6%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e0.999\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eMultiple re-intervention (N,%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e0 (0%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e5 (11.4%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e0.161\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003c/tbody\u003e \u003c/colgroup\u003e \u003c/table\u003e\u003c/div\u003e \u003c/p\u003e \u003cp\u003eICU\u0026thinsp;=\u0026thinsp;intensive care unit; LOS\u0026thinsp;=\u0026thinsp;length of stay.\u003c/p\u003e \u003cp\u003e \u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab4\" border=\"1\"\u003e \u003ccaption language=\"En\"\u003e \u003cdiv class=\"CaptionNumber\"\u003eTable 4\u003c/div\u003e \u003cdiv class=\"CaptionContent\"\u003e \u003cp\u003eOutcomes for patients with intended biventricular repair pathway related to palliative procedure.\u003c/p\u003e \u003c/div\u003e \u003c/caption\u003e \u003ccolgroup cols=\"4\"\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c4\" colnum=\"4\"\u003e\u003c/div\u003e \u003cthead\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/th\u003e \u003cth align=\"left\" colname=\"c2\"\u003e \u003cp\u003eDuctal Stent, n\u0026thinsp;=\u0026thinsp;28\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c3\"\u003e \u003cp\u003eBT Shunt, n\u0026thinsp;=\u0026thinsp;42\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c4\"\u003e \u003cp\u003eP value\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003c/thead\u003e \u003ctbody\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eProcedural failure\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e1 (3.6%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e-\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e-\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eICU LOS, median (IQR)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e7 (5, 15)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e17 (7, 30)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e\u003cb\u003e0.030\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eHospital LOS, median (IQR)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e9 (6, 21)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e20 (11, 40)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e\u003cb\u003e0.011\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eDeath (Overall), (N,%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e0 (0%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e5 (11.9%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e0.149\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eDeath\u0026thinsp;\u0026lt;\u0026thinsp;30 days\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e0 (0%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e2 (4.8%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e0.513\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eDeath\u0026thinsp;\u0026gt;\u0026thinsp;30 days\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e0 (0%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e3 (7.1%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e0.275\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e1st Reintervention (unplanned)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e3 (10.7%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e12 (28.6%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e\u003cem\u003e0.078\u003c/em\u003e\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e1st Reintervention (planned)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e3 (10.7%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e5 (11.9%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e0.715\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eMultiple re-intervention (N,%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e0 (0%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e4 (9.5%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e0.141\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003c/tbody\u003e \u003c/colgroup\u003e \u003c/table\u003e\u003c/div\u003e \u003c/p\u003e \u003cp\u003eICU\u0026thinsp;=\u0026thinsp;intensive care unit; LOS\u0026thinsp;=\u0026thinsp;length of stay.\u003c/p\u003e \u003cp\u003eThe risks of death and/or unplanned re-intervention between the four groups are shown in Table\u0026nbsp;\u003cspan refid=\"Tab5\" class=\"InternalRef\"\u003e5\u003c/span\u003e. The BiV BTTS group had a significantly increased risk of death and or unplanned re-intervention compared to BiV DS participants (HR 4.28; CI 1.25\u0026ndash;14.6; p\u0026thinsp;=\u0026thinsp;0.02). Time to unplanned re-intervention or death was similar in the SV group regardless of DS or BTTS. Kaplan Meir curves showing time to death (Fig.\u0026nbsp;\u003cspan refid=\"Fig1\" class=\"InternalRef\"\u003e1\u003c/span\u003ea) and time to unplanned reintervention (Fig.\u0026nbsp;\u003cspan refid=\"Fig1\" class=\"InternalRef\"\u003e1\u003c/span\u003eb) highlight a survival advantage for BiV patients undergoing DS.\u003c/p\u003e \u003cp\u003e \u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab5\" border=\"1\"\u003e \u003ccaption language=\"En\"\u003e \u003cdiv class=\"CaptionNumber\"\u003eTable 5\u003c/div\u003e \u003cdiv class=\"CaptionContent\"\u003e \u003cp\u003eCox proportional hazards model for time to unplanned re-intervention or death.\u003c/p\u003e \u003c/div\u003e \u003c/caption\u003e \u003ccolgroup cols=\"7\"\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e \u003cdiv align=\"char\" char=\".\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e \u003cdiv align=\"char\" char=\".\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c4\" colnum=\"4\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c5\" colnum=\"5\"\u003e\u003c/div\u003e \u003cdiv align=\"char\" char=\".\" class=\"colspec\" colname=\"c6\" colnum=\"6\"\u003e\u003c/div\u003e \u003cdiv align=\"char\" char=\".\" class=\"colspec\" colname=\"c7\" colnum=\"7\"\u003e\u003c/div\u003e \u003cthead\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c1\" morerows=\"1\" rowspan=\"2\"\u003e\u0026nbsp;\u003c/th\u003e \u003cth align=\"left\" colspan=\"2\" nameend=\"c3\" namest=\"c2\"\u003e \u003cp\u003eTime to unplanned reintervention, death as competing risk\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colspan=\"2\" nameend=\"c5\" namest=\"c4\"\u003e \u003cp\u003eTime to death\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colspan=\"2\" nameend=\"c7\" namest=\"c6\"\u003e \u003cp\u003eTime to unplanned re-intervention or death\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c2\"\u003e \u003cp\u003eHR (95% CI)\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c3\"\u003e \u003cp\u003ep-value\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c4\"\u003e \u003cp\u003eHR (95% CI)\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c5\"\u003e \u003cp\u003ep-value\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c6\"\u003e \u003cp\u003eHR (95% CI)\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c7\"\u003e \u003cp\u003ep-value\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003c/thead\u003e \u003ctbody\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eBTTS SV vs. DS SV\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e3.22 (0.40, 25.74)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e0.271\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e0.74 (0.22, 2.55)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e0.639\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c6\"\u003e \u003cp\u003e1.10 (0.39, 3.13)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c7\"\u003e \u003cp\u003e0.853\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eBTTS SV vs. BTTS BiV\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e1.92 (0.77, 4.78)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e0.160\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e0.69 (0.22, 2.18)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e0.531\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c6\"\u003e \u003cp\u003e1.59 (0.76, 3.33)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c7\"\u003e \u003cp\u003e0.222\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eBTTS BiV vs. DS BiV\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e3.00 (0.89, 10.16)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e\u003cem\u003e0.078\u003c/em\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003eNA*\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e-\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c6\"\u003e \u003cp\u003e\u003cb\u003e4.28 (1.25, 14.61)\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c7\"\u003e \u003cp\u003e\u003cb\u003e0.023\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eDS SV vs. DS BiV\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e0.50 (0.05, 4.75)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e0.549\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003eNA*\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e-\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c6\"\u003e \u003cp\u003e2.57 (0.61, 10.79)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c7\"\u003e \u003cp\u003e0.196\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003c/tbody\u003e \u003c/colgroup\u003e \u003ctfoot\u003e \u003ctr\u003e\u003ctd colspan=\"7\"\u003eBTTS\u0026thinsp;=\u0026thinsp;Blalock-Taussig-Thomas shunt; DS\u0026thinsp;=\u0026thinsp;ductal stent; SV\u0026thinsp;=\u0026thinsp;single ventricle; BiV\u0026thinsp;=\u0026thinsp;biventricular; NA* = comparison not possible as no deaths occurred in the DS BiV group\u003c/td\u003e\u003c/tr\u003e \u003c/tfoot\u003e \u003c/table\u003e\u003c/div\u003e \u003c/p\u003e \u003cp\u003e \u003c/p\u003e \u003c/div\u003e"},{"header":"Discussion","content":"\u003cp\u003eIn this study, we specifically examined the impact of intended SV and BiV repair pathways on the outcome of DS and BTTS procedures in infants with DDPBF. Our principle findings were that: i) in BiV patients, death or unplanned reintervention is lower after DS than BTTS, ii) length of ICU and/or overall hospital LOS is lower after DS than BTTS and iii) in SV patients, risk of death or unplanned reintervention is similar after DS and BTTS.\u003c/p\u003e \u003cp\u003e \u003cem\u003eImpact of DS versus BTTS palliation on survival and unplanned re-intervention in SV physiology.\u003c/em\u003e \u003c/p\u003e \u003cp\u003eA recent meta-analysis found an equivalent 30-day mortality after DS and BTTS, lower medium-term mortality after DS (HR\u0026thinsp;=\u0026thinsp;0.6; CI\u0026thinsp;=\u0026thinsp;0.4\u0026ndash;0.99; p\u0026thinsp;=\u0026thinsp;0.05) and increased risk of unplanned re-interventions after DS (HR\u0026thinsp;=\u0026thinsp;1.77; CI\u0026thinsp;=\u0026thinsp;1.39\u0026ndash;2.26; p\u0026thinsp;\u0026lt;\u0026thinsp;0.01) [\u003cspan citationid=\"CR4\" class=\"CitationRef\"\u003e4\u003c/span\u003e]. The larger studies comparing DS and BTTS have included substantial numbers of patients with intended SV pathway. Glatz et al. [\u003cspan citationid=\"CR6\" class=\"CitationRef\"\u003e6\u003c/span\u003e], in a multi-centre US study comparing 106 infants undergoing DS (60% BiV) versus 251 with BTTS (45% BiV), accounted for SV physiology amongst other baseline factors, by propensity score adjustment. These authors found no difference in death or unplanned re-interventions to treat cyanosis between the groups. In contrast, Bentham et al. [\u003cspan citationid=\"CR7\" class=\"CitationRef\"\u003e7\u003c/span\u003e], in a multi-centre UK study of 83 infants undergoing DS (53% BiV) versus 171 with a BTTS (43% BiV), found lower mortality in the DS group after propensity score adjustment for baseline factors including SV status.\u003c/p\u003e \u003cp\u003eFew studies have specifically compared DS and BTTS outcomes for SV versus BiV patients with conflicting results. For example, Meadows et al [\u003cspan citationid=\"CR8\" class=\"CitationRef\"\u003e8\u003c/span\u003e]. reported on 171 SV infants with duct dependent pulmonary blood flow (n\u0026thinsp;=\u0026thinsp;136 receiving BTTS and n\u0026thinsp;=\u0026thinsp;35 receiving DS). Interstage mortality and unplanned reintervention did not differ between the groups. In contrast, Prabhu et al [\u003cspan citationid=\"CR9\" class=\"CitationRef\"\u003e9\u003c/span\u003e], reporting outcomes in SV infants after DS (n\u0026thinsp;=\u0026thinsp;11) and BTTS (n\u0026thinsp;=\u0026thinsp;23), found a higher proportion of survival to stage II surgery after DS (100% versus 64%, p\u0026thinsp;=\u0026thinsp;0.035). Our data contributes to the evidence that interstage mortality and unplanned re-interventions are similar after DS and BTTS in SV patients. The choice of initial palliation may depend upon other short and long term benefits of one or other strategy. This is in contrast with infants with a BiV circulation, where DS appears to convey clear survival advantages.\u003c/p\u003e \u003cp\u003e \u003cem\u003eImpact of DS versus BTTS palliation on length of stay and costs of intervention.\u003c/em\u003e \u003c/p\u003e \u003cp\u003eNumerous studies, including ours, have shown shorter ICU and hospital LOS after DS compared to BTTS [\u003cspan citationid=\"CR6\" class=\"CitationRef\"\u003e6\u003c/span\u003e, \u003cspan citationid=\"CR10\" class=\"CitationRef\"\u003e10\u003c/span\u003e]. In a recent report utilizing data from the Pediatric Health Information System of infants undergoing DS and BTTS between January 2016 and December 2021, DS was associated with 11 days shorter post-intervention hospital length of stay (95% CI 7.2\u0026ndash;14.8; p\u0026thinsp;\u0026lt;\u0026thinsp;0.001) but with higher 3- and 6-month reintervention rates [\u003cspan citationid=\"CR11\" class=\"CitationRef\"\u003e11\u003c/span\u003e]. The overall costs related to the index hospitalization were significantly lower after DS than BTTS (\u003cspan\u003e$\u003c/span\u003e120 400 versus \u003cspan\u003e$\u003c/span\u003e198 300, p\u0026thinsp;\u0026lt;\u0026thinsp;0.001), although these costs did not include those related to reintervention. The overall health care costs of SV care are high [\u003cspan citationid=\"CR12\" class=\"CitationRef\"\u003e12\u003c/span\u003e, \u003cspan citationid=\"CR13\" class=\"CitationRef\"\u003e13\u003c/span\u003e] and whether DS palliation has any impact on these costs remain to be determined.\u003c/p\u003e\n\u003ch3\u003eImpact of DS versus BTTS palliation on pulmonary artery growth\u003c/h3\u003e\n\u003cp\u003eThe data on the benefits of either DS or BTTS palliation on pulmonary artery development remain varied. For example, in the mixed cohort reported by Bentham et al. [\u003cspan citationid=\"CR7\" class=\"CitationRef\"\u003e7\u003c/span\u003e], pulmonary artery size prior to the next stage was similar but the need for pulmonary artery augmentation was greater after DS. In contrast, Glatz et al. [\u003cspan citationid=\"CR6\" class=\"CitationRef\"\u003e6\u003c/span\u003e] showed larger and more symmetrical pulmonary arteries after DS compared to BTTS at the time of subsequent surgical repair or at last follow-up. In the study of SV patients, Meadows et al. [\u003cspan citationid=\"CR8\" class=\"CitationRef\"\u003e8\u003c/span\u003e], found similar pulmonary artery growth and pre-stage II cardiac catheterization haemodynamic findings after DS and BTTS. Examination of pulmonary artery growth was beyond the scope of our current study but remains an area of interest.\u003c/p\u003e\n\u003ch3\u003eLimitations\u003c/h3\u003e\n\u003cp\u003eThis study was limited by its retrospective nature and small sample size. It encompasses the entire clinical experience with DS procedures at a single institute and therefore may be subject to institutional practice that limit the applicability of the data more broadly. With near exclusive DS from 2017, there was a learning curve effect for the interventionalists as the case/procedural complexity increased which may have impacted the results related to DS. The same learning curve was clearly not present for BTTS. As there were no deaths in the BiV DS group we were unable to determine the risk of mortality in this group separately to unplanned re-intervention.\u003c/p\u003e"},{"header":"Conclusion","content":"\u003cp\u003eThis study demonstrated a combined survival/unplanned re-intervention benefit for BiV participants undergoing DS compared to DS in SV participants and BTTS in BiV participants. There was no difference in the outcomes between SV participants based on procedure type. Regardless of intended SV or BiV pathway, DS procedures had an advantage compared with BTTS for ICU and hospital LOS. Ultimately, DS compared to BTTS is not an inferior approach to stage one palliation for DDPBF lesions with a clear mortality benefit in BiV patients and shorter hospital LOS in both SV and BiV pathways.\u003c/p\u003e"},{"header":"Declarations","content":"\u003ch2\u003eAuthor Contribution\u003c/h2\u003e\u003cp\u003eThe authors confirm contribution to the paper as follows: study conception and design: N.F, P.A, J.M, P.R and J.A; review board/ethics application: N.F and J.A; data collection: N.F; analysis and interpretation of results: N.F, A.W and J.A; draft manuscript preparation: N.F; progress review of manuscript: J.M, P.R and J.A. All authors reviewed the results and approved the final version of the manuscript.\u003c/p\u003e\u003cp\u003e\u003cstrong\u003eDisclosures / conflict of interest\u003c/strong\u003e: None for any of the authors\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eFinancial support\u003c/strong\u003e: None\u003c/p\u003e"},{"header":"References","content":"\u003col\u003e\u003cli\u003e\u003cspan\u003eSasikumar N, Hermuzi A, Lee KJ et al (2017) Outcomes of Blalock-Taussig shunts in current era: a single centre experience. Congenit Heart Dis 12(6):808\u0026ndash;814. \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003e10.1111/chd.12516\u003c/span\u003e\u003cspan address=\"10.1111/chd.12516\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eGibbs J, Rothman M, Rees M, Parsons J, Blackburn M, Ruiz C (1993) Stenting of the arterial duct; a new approach to palliation for pulmonary atresia. 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Am J Cardiol 120(3):467\u0026ndash;472. \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003e10.1016/j.amjcard.2017.04.049\u003c/span\u003e\u003cspan address=\"10.1016/j.amjcard.2017.04.049\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eO\u0026rsquo;Byrne M, McHugh K, Huang J, Song L, Griffis H, Anderson B et al (2022) Cumulative in-hospital costs associated with single-ventricle palliation. JACC Adv 1(2). \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003ehttps://doi.org/10.1016/j.jacadv.2022.100029\u003c/span\u003e\u003cspan address=\"10.1016/j.jacadv.2022.100029\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e\u003c/span\u003e\u003c/li\u003e \u003c/ol\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":"researchsquare","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":true,"externalIdentity":"","sideBox":"","snPcode":"","submissionUrl":"/submission","title":"Research Square","twitterHandle":"researchsquare","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"","reportingPortfolio":"","inReviewEnabled":false,"inReviewRevisionsEnabled":true},"keywords":"Duct-dependent pulmonary blood flow (DDPBF), Single ventricle, Patent ductus arteriosus (PDA), Catheter intervention, Ductal Stent, Blalock-Taussig-Thomas Shunt","lastPublishedDoi":"10.21203/rs.3.rs-4088296/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-4088296/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003cp\u003e\u003cstrong\u003eBackground\u003c/strong\u003e: Ductal stenting (DS) is an alternative to the Blalock-Taussig-Thomas Shunt (BTTS) as initial palliation for congenital heart disease with duct dependent pulmonary blood flow (DDBPF). We sought to analyse the impact of intended single ventricle (SV) and biventricular (BiV) repair pathways on the outcome of DS and BTTS in infants with DDPBF.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eMethods\u003c/strong\u003e: A single-centre, retrospective comparison of infants with DDPBF who underwent either DS (2012-2022) or BTTS procedures (2013-2017). Primary outcomes included all-cause mortality and risk of unplanned re-intervention. Participants were divided into four groups: 1.SV with DS, 2.SV with BTTS, 3.BiV with DS and 4.BiV with BTTS.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eResults\u003c/strong\u003e: Fifty-one DS (SV 45%) and 86 BTTS (SV 49%) procedures were undertaken. For those who had DS, mortality was lower in the BiV compared to SV patients (BiV: 0/28, versus SV: 4/23, P=0.04). Compared to BiV DS, BiV BTTS had a higher risk of combined death or unplanned re-intervention (HR 4.28; CI 1.25-14.60; p=0.02). In SV participants, there was no difference for either primary outcome based on procedure type. DS was associated with shorter intensive care length of stay for SV participants (mean difference 5 days, P=0.01) and shorter intensive care and hospital stay for BiV participants (mean difference 11 days for both outcomes, P=0.001).\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eConclusions\u003c/strong\u003e:\u003c/p\u003e\n\u003cp\u003eThere is a survival benefit for DS in BiV participants compared with DS in SV and BTTS in BiV participants. Ductal stenting is associated with a shorter intensive care and hospital length of stay.\u003c/p\u003e","manuscriptTitle":"A comparison of ductal stenting and surgical shunts for infants with duct-dependent pulmonary blood flow; the impact of single versus biventricular repair pathways on outcomes.","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2024-03-15 20:15:58","doi":"10.21203/rs.3.rs-4088296/v1","editorialEvents":[{"type":"communityComments","content":0}],"status":"published","journal":{"display":true,"email":"
[email protected]","identity":"researchsquare","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":true,"externalIdentity":"","sideBox":"","snPcode":"","submissionUrl":"/submission","title":"Research Square","twitterHandle":"researchsquare","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"","reportingPortfolio":"","inReviewEnabled":false,"inReviewRevisionsEnabled":true}}],"origin":"","ownerIdentity":"fc8d2f81-96aa-40bb-b5db-8a51da1a6b9c","owner":[],"postedDate":"March 15th, 2024","published":true,"recentEditorialEvents":[],"rejectedJournal":[],"revision":"","amendment":"","status":"published-in-journal","subjectAreas":[],"tags":[],"updatedAt":"2024-07-28T20:19:29+00:00","versionOfRecord":{"articleIdentity":"rs-4088296","link":"https://doi.org/10.1016/j.hlc.2024.06.791","journal":{"identity":"heart-lung-and-circulation","isVorOnly":true,"title":"Heart, Lung and Circulation"},"publishedOn":"2024-08-01 20:19:29","publishedOnDateReadable":"August 1st, 2024"},"versionCreatedAt":"2024-03-15 20:15:58","video":"","vorDoi":"10.1016/j.hlc.2024.06.791","vorDoiUrl":"https://doi.org/10.1016/j.hlc.2024.06.791","workflowStages":[]},"version":"v1","identity":"rs-4088296","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-4088296","identity":"rs-4088296","version":["v1"]},"buildId":"qtupq5eGEP_6zYnWcrvyt","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}
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