Outcomes of transcatheter pulmonary SAPIEN 3 valve implantation: an international registry.

BACKGROUND AND AIMS: Transcatheter pulmonary valve implantation (TPVI) is indicated to treat right-ventricular outflow tract (RVOT) dysfunction related to congenital heart disease (CHD). Outcomes of TPVI with the SAPIEN 3 valve that are insufficiently documented were investigated in the EUROPULMS3 registry of SAPIEN 3-TPVI. METHODS: Patient-related, procedural, and follow-up outcome data were retrospectively assessed in this observational cohort from 35 centres in 15 countries. RESULTS: Data for 840 consecutive patients treated in 2014-2021 at a median age of 29.2 (19.0-41.6) years were obtained. The most common diagnosis was conotruncal defect (70.5%), with a native or patched RVOT in 50.7% of all patients. Valve sizes were 20, 23, 26, and 29 mm in 0.4%, 25.5%, 32.1%, and 42.0% of patients, respectively. Valve implantation was successful in 98.5% [95% confidence interval (CI), 97.4%-99.2%] of patients. Median follow-up was 20.3 (7.1-38.4) months. Eight patients experienced infective endocarditis; 11 required pulmonary valve replacement, with a lower incidence for larger valves (P = .009), and four experienced pulmonary valve thrombosis, including one who died and three who recovered with anticoagulation. Cumulative incidences (95%CI) 1, 3, and 6 years after TPVI were as follows: infective endocarditis, 0.5% (0.0%-1.0%), 0.9% (0.2%-1.6%), and 3.8% (0.0%-8.4%); pulmonary valve replacement, 0.4% (0.0%-0.8%), 1.3% (0.2%-2.4%), and 8.0% (1.2%-14.8%); and pulmonary valve thrombosis, 0.4% (0.0%-0.9%), 0.7% (0.0%-1.3%), and 0.7% (0.0%-1.3%), respectively. CONCLUSIONS: Outcomes of SAPIEN 3 TPVI were favourable in patients with CHD, half of whom had native or patched RVOTs.

Mobile bedside ductus arteriosus closure in severely premature neonates using only echocardiographic guidance.

BACKGROUND: Transcatheter closure of the patent ductus arteriosus (PDA) in premature infants is currently dependent on fluoroscopic guidance and transportation to the catheterization laboratory. AIM: We describe a new echocardiographically guided technique to allow our team to move to the bedside at the neonatal intensive care unit (NICU) of the referring center for percutaneous treatment of PDA in premature infants. METHODS: This is a single-center, retrospective, primarily descriptive analysis. Clinical details about the procedure, its outcomes, and complications were collected. RESULTS: Fifty-eight neonates with a median weight of 1110 g (range 730-2800) and postnatal age of 28 days (range 9-95) underwent percutaneous PDA closure. Five of them were treated in our center with ultrasound guidance only and the other 53 in 18 different neonatology units in 12 towns. The median duration of the procedure was 40 min (range 20-195 min). There were no procedural deaths. There was one residual shunt for 3 weeks, in all other patients the duct closed completely in the first few hours after the intervention. In one patient the procedure had to be interrupted because of a pericardial effusion which had to be drained, the PDA was closed successfully interventionally 5 days later. One device-related aortic coarctation had to be stented. One embolization and one late migration occurred and required treatment. CONCLUSIONS: Echocardiographically guided transcatheter closure of the PDA in prematures was repeatedly possible and allowed that the procedure is performed at the bedside at the NICU with an acceptable rate of complications.

Relationship of Aortopulmonary Collaterals and Pulmonary Artery Development During Staged Single Ventricle Reconstruction.

To evaluate the relationship of aortopulmonary collaterals and the development of central pulmonary arteries during staged palliation. A total of 287 patients, who underwent staged palliation with bidirectional cavopulmonary shunt and total cavopulmonary connection between 2008 and 2019, had available angiography. Pulmonary artery index was calculated using pulmonary angiography as described by Nakata and colleagues. Aortopulmonary collaterals were observed in 47 (16%) patients at stage II palliation, in 131 (46%) at total cavopulmonary connection, and afterwards in 49 (7%). The interventional closure of aortopulmonary collaterals was performed before stage II in 12 (4%) patients, before Fontan completion in 38 (13%), and afterwards in 39 (14%). Presence of aortopulmonary collaterals before stage II was not associated with the pulmonary artery index (129 vs. 150 mm2/m2, p = 0.176) at stage II. In contrast, aortopulmonary collaterals before the Fontan completion were associated with lower pulmonary artery index (154 vs. 172 mm2/m2, p = 0.005), and right pulmonary artery index (99 vs. 106 mm2/m2, p = 0.006). Patients who underwent interventional closure of aortopulmonary collaterals before total cavopulmonary connection had lower pulmonary artery index (141 vs. 169 mm2/m2, p < 0.001), lower right pulmonary artery index (93 vs. 106 mm2/m2, p = 0.007), and left pulmonary artery index (54 vs. 60 mm2/m2, p = 0.013) at Fontan completion. The presence of aortopulmonary collaterals did not influence pulmonary artery size by the time of stage II. However, presence of aortopulmonary collaterals was associated with under-developed pulmonary arteries at Fontan completion, especially in patients who needed interventional closure of aortopulmonary collaterals.

Transcatheter implantation of covered stents serving as extravascular conduits-Proof of a CT-based approach in three cases.

BACKGROUND: Covered stents perform similar to surgically implanted conduits, although the stents work inside of vessels. We present a computed tomography (CT)-based workflow for the implantation of covered stents as extravascular conduits. METHODS: We selected three different use cases: 1. Connecting a left-sided partially anomalous drainage of a pulmonary vein to the left atrium. 2. Bypassing an outgrown Dacron conduit in aortic recoarctation. 3. Re-directing hepatic venous blood to the left lung in a Fontan patient with heterotaxy, connecting the innominate vein to the right pulmonary artery like a right-sided cavopulmonary connection. By postprocessing and analyzing CT scans for planning and by the use of long needles under biplane fluoroscopy for the realization of the procedure, we projected and performed the exit of a long needle out of a vessel, the re-entering of a target vessel, and the bridging of the extravascular distance by implantation of covered stents. RESULTS: In all three cases, the covered stents were placed successfully, connecting vessels of 15-50 mm distance from each other with very good hemodynamic results. In one case, two stents were placed consecutively, overlapping each other to accomplish an exact fitting at the connection sites to the native vessels.

Transcatheter creation of bidirectional cavopulmonary connections by needle punctures in two patients.

We report on two patients who received a transcatheter cavopulmonary connection by a needle puncture under deep conscious sedation. In both patients, the vessel-to-vessel connection was achieved by a venous access into the superior caval vein and direct needle puncture of the pulmonary artery. The two cavopulmonary anastomoses were held open by a covered stent and a bare-metal stent, respectively.

Percutaneous catheter interventions via Glidesheath Slender in small children.

BACKGROUND: Catheterization in small children should be performed with the lowest diameter introducer sheaths to prevent permanent vessel damage. The objective of this study is to evaluate the clinical safety and efficacy of the Glidesheath Slender in small children. METHODS AND RESULTS: We present a group of 52 patients (male: n = 36) with median age 118.5 days (min. 3; max. 1302), median weight: 5.3 kg (min. 1.4; max. 14.0), median height: 60.5 cm (min. 39; max. 102), and median body surface area 0.28 m2 (min. 0.12; max. 0.63) in whom percutaneous catheter interventions (n = 55) were performed via a Glidesheath Slender. In 49 children, the intervention was performed from femoral access (artery n = 35; vein n = 14) in 2 from the axillary arterial access and in 1 from the jugular venous access. In all patients, the vessel access was obtained under ultrasound guidance. After the catheterization, the pulse on the peripheral arteries (posterior tibial artery or radial artery) was palpable in all patients, and no signs for vessel dysfunction were present. CONCLUSION: The Glidesheath Slender effectively reduces the outer sheath diameter for various types of interventions in small children by one French, reducing the risk of vessel complications (stenosis, occlusion). Interventions via Glidesheath Slender in small patients are safe and feasible and extend the transcatheter possibilities in small children with congenital heart diseases.

Retrieval of large Occlutech Figula Flex septal defect occluders using a commercially available bioptome: proof of concept.

OBJECTIVES: This study aimed to develop a method for retrieval of the new meshed nitinol atrial septal defect occluders - Ceraflex and Occlutech. BACKGROUND: The newly developed atrial septal defect occluders have potential benefits considering implantation, but concerns regarding their removal in case of embolisation have been raised. METHODS: Over 21 years, 1449 patients underwent interventional atrial septal defect occlusion in our institution. We reviewed the cases of embolisation of the device, developed a strategy for device removal, and tested it on the benchside and in animal tests. RESULTS: In 11 patients (0.8%), the intended atrial septal defect occlusion was complicated by an embolisation of the device. In contrast to the Amplatzer septal occluders, retrieval of Occlutech devices larger than 16 mm with snare techniques was impossible. In benchside tests, this was confirmed and a new method for removal of large meshed devices was developed. This involved the commercially available Maslanka® biopsy forceps. The feasibility of this technique in vivo was tested in a pig model. During animal tests, using the Maslanka biopsy forceps it was possible to interventionally retrieve embolised Ceraflex and Occlutech devices of different sizes - 10, 16, 30, and 40 mm - into a 12-F sheath. CONCLUSION: It was impossible to retrieve Occlutech and Ceraflex devices larger than 16 mm into a large sheath in vivo and during benchside tests. However, this was feasible on the bench and in vivo using the Maslanka biopsy forceps even with the largest available devices.

Aortic rupture during stenting for recurrent aortic coarctation in an adult: live-saving, emergency, NuDEL all-in-one covered stent implantation.

We report a case of successful, life-saving implantation of a covered Cheatham Platinum stent, an all-in-one NuDEL catheter system, in an adult with aortic rupture after bare-metal stenting for re-coarctation of the aorta.

Early postoperative extubation of unstable patients following total cavopulmonary connection: impact on circulation and outcome.

OBJECTIVES: We aimed to investigate whether early postoperative extubation following the Fontan operation is universally feasible and can be used as a management tool in unstable patients. METHODS: All patients undergoing the Fontan operation in our centre between 2004 and 2013 (n=253) were analysed. Until 2008, patients were extubated according to standard criteria and comprised group 1. Group 2 included all patients presenting after 2009, when early extubation was always aimed regardless of the haemodynamic status. Patients who exceeded the 75th percentiles for volume requirements and inotrope scores for the respective group were defined as unstable. Comparisons of outcomes between groups and subgroups and analysis of the changes in haemodynamic and treatment parameters with extubation in unstable patients after 2009 were performed. RESULTS: Compared with group 1, patients from group 2 were ventilated for shorter duration (p<0.001), had similar re-intubation rates (p=0.50), and needed less volume (p=0.01). In group 2, the unstable patients were not ventilated for longer durations (p=0.19), but had higher re-intubation rates (p=0.03) than the stable patients. Compared with the unstable patients from group 1, the unstable patients from group 2 were ventilated for shorter duration (p<0.001), had similar re-intubation rates (p=0.66), and needed less volume (p=0.006). There was a significant acute and sustained increase in mean arterial pressure with extubation and a parallel reduction in volume requirements and inotrope scores in the unstable patients from group 2. CONCLUSIONS: Timely extubation is universally applicable following the Fontan operation. Early postoperative extubation can be valuable for improving Fontan haemodynamics.

Proof of Concept: A New Solution for Low-Profile Transcatheter Implantation of Optimus-L Stents in Small Children.

BACKGROUND: There is no stent designed or approved for use in infants. We sought to obtain in vitro and in vivo data on a new concept conceived to implant Optimus-L stents at infant vessel diameters and offer a potential long term stent solution. METHODS: Nineteen Optimus-L stents were mounted on 8 types of angioplasty balloons with diameters 6, 8, and 10 mm with the use of an injection-moulded hand crimper. We evaluated balloon-stent unit (BSU) stability before insertion and advancement through short Terumo introducers with incremental French size and possibility of side-arm contrast injections. Three types of long sheaths were tested. Stents were inflated to balloon nominal diameters and re-expanded to 18 and 23 mm. Stent recoil, foreshortening, and fracture were evaluated. In vivo implantations were performed afterward. RESULTS: In vitro: Medtronic Evercross balloons and modified Terumo Destination sheaths were the best combination: BSUs were inserted in 6 F sheaths with possible injections (for 6 and 8 mm balloons), and 7 F sheaths without injections (for the 10 mm balloon). Retrieving BSUs inside the sheath required 1 additional F-size. Boston Scientific Sterling and Balton Lovix balloons, as well as APT Braidin L guiding sheaths showed unsatisfactory performance. Dilation up to 23 mm was possible, and stent shortening was < 24% at 18 mm and < 37% at 23 mm. Recoil was limited, and no stent fractured. In vivo: Optimus-L stents were used to treat 2 infants with aortic coarctation and 2 children with pulmonary artery stenosis with the use of 8 mm balloons and low-profile access. CONCLUSIONS: Optimus-L stents can be implanted safely in small patients with a low-profile approach. These stents have the potential to achieve adult size while maintaining structural integrity.

Morphology of the native ascending aorta after the Norwood procedure for aortic atresia: impact on survival and right ventricular dysfunction.

OBJECTIVES: To evaluate the impact of variable morphology of the native ascending aorta after the Norwood I procedure in patients with hypoplastic left heart syndrome/aortic atresia on long-term survival and systemic right ventricular dysfunction. METHODS: Of 151 survivors of the Norwood procedure for hypoplastic left heart syndrome/aortic atresia at our institution between January 2001 and December 2020, we included patients with available and measurable aortography prior to stage II palliation. Diameter of the native ascending aorta, length of the native ascending aorta, and the angle between the the native ascending aorta and the proximal pulmonary artery were measured. We investigated the impact of these morphologic parameters on the mortality and the right ventricular dysfunction (defined as at least moderate). RESULTS: Angiography was available in 78 patients. Median diameter of native ascending aorta was 3.2 mm (2.6-3.7), median length of native ascending aorta was 15.4 mm (13.3-17.9), and median angle between the native ascending aorta and the proximal pulmonary artery was 44° (35° - 51°). During median follow-up of 6.5 years, eight (10%) patients died and systemic right ventricular dysfunction occurred in 19 patients (24%). No significant association between the aortic morphology and mortality could be detected. Right ventricular function was negatively affected by a larger angle between the native ascending aorta and the proximal pulmonary artery and (odds ratio 1.07 [1.01-1.14], P= 0.02). CONCLUSIONS: In survivors of the Norwood procedure for hypoplastic left heart syndrome/aortic atresia with available angiography, no significant association between the native aortic morphology and mortality could be demonstrated after stage II palliation, within the scope of this limited study. A larger anastomosis angle between the native ascending aorta and the proximal pulmonary artery emerged as a risk factor for right ventricular dysfunction.

Impact of veno-venous collaterals on outcome after the total cavopulmonary connection.

OBJECTIVE: To evaluate the prevalence of veno-venous collaterals (VVCs) after total cavopulmonary connection (TCPC) and analyze their impact on outcomes. METHODS: Patients undergoing TCPC between 1994 and 2022 were evaluated. VVCs were identified using angiograms of cardiac catheterizations and their impact on outcomes was analyzed. RESULTS: A total of 635 patients were included. Median age at TCPC was 2.3 (interquartile ranges (IQR): 1.8-3.3) years. The most frequent diagnosis was hypoplastic left heart syndrome in 173 (27.2%) patients. Prior bidirectional cavopulmonary shunt was performed in 586 (92.3%) patients at a median age of 5.3 (3.6-9.9) months. VVCs were found in 94 (14.8%) patients at a median of 2.8 (0.1-11.8) years postoperatively. The prevalence of VVCs was similar between the dominant right and left ventricle (14.7 vs. 14.9%, p = 0.967). Mean pulmonary artery pressure (16.2 vs. 16.0 mmHg, p = 0.902), left atrial pressure (5.5 vs. 5.7 mmHg, p = 0.480), transpulmonary gradient (4.0 vs. 3.8 mmHg, p = 0.554) and oxygen saturation (81.4 vs. 82.6%, p = 0.103) before TCPC were similar between patients with and without VVCs. The development of VVCs did not affect survival after TCPC (p = 0.161). Nevertheless, VVCs were a risk for the development of plastic bronchitis (PB, p < 0.001). Interventional closure of VVCs was performed in 60 (9.4%) patients at a median of 8.9 (0.6-15.1) years after TCPC, and improvement of oxygen saturation was observed in 66% of the patients. CONCLUSIONS: The prevalence of VVCs after TCPC was 15%. VVCs had no impact on survival following TCPC but were associated with a high prevalence of PB.

Comparison of ductus stent versus surgical systemic-to-pulmonary shunt as initial palliation in patients with univentricular heart.

OBJECTIVES: In this study, we aimed to compare infants with univentricular hearts who underwent an initial ductus stenting to those receiving a surgical systemic-to-pulmonary shunt (SPS). METHODS: All infants with univentricular heart and ductal-dependent pulmonary blood flow who underwent initial palliation with either a ductus stenting or a surgical SPS between 2009 and 2022 were reviewed. Outcomes were compared after ductus stenting or SPS including survival, probability of re-interventions and the probability to reach stage II palliations. RESULTS: A total of 130 patients were evaluated, including 49 ductus stenting and 81 SPSs. The most frequent primary diagnosis was tricuspid atresia in 27, followed by pulmonary atresia with intact ventricular septum in 19 patients. There was comparable hospital mortality (2.0% stent vs 3.7% surgery, P = 0.91) between the groups, but shorter intensive care unit stay (median 1 vs 7 days, P < 0.01) and shorter hospital stay (median 7 vs 17 days, P < 0.01) were observed in patients with initial ductus stenting, compared to those with SPS. However, acute procedure-related complications were more frequently observed in patients with ductus stenting, compared with those with SPS (20.4 vs 6.2%, P = 0.01), and 10 patients needed a shunt procedure after the initial ductus stent. The cumulative incidence of reaching stage II was similar between ductus stenting and SPS (88.0 vs 90.6% at 12 months, P = 0.735). Pulmonary artery (PA) index (median 194 vs 219 mm2/m2, P = 0.93) at stage II was similar between patients with ductus stenting and SPS. However, the ratio of the left to the right PA index [0.69 (0.45-0.95) vs 0.86 (0.51-0.84), P = 0.015] was higher in patients who reached stage II with surgical shunt physiology, compared with patients with ductus stent physiology. CONCLUSIONS: After initial ductus stenting in infants with univentricular heart, survival is comparable and post-procedural recovery shorter, but more acute stent dysfunctions and lower development of left PA are observed, compared to acute shunt dysfunctions. The less invasive procedure and shorter hospital stay are at the expense of more stent reinterventions.

Temporary tricuspid valve detachment for ventricular septal defect closure: is it worth doing it?

BACKGROUND: Tricuspid valve detachment (TVD) may improve the access for closing certain ventricular septal defects (VSDs), but it has some potential risks. We aimed to study the benefits and drawbacks of this technique. METHODS: The midterm outcomes of all 20 patients who underwent a TVD closure for VSD were reviewed and compared with a control group of 15 patients with VSD closure without TVD. RESULTS: There was no significant residual shunt in either group at the last actuarial follow-up. Tricuspid regurgitation occurred in both groups (45% in the TVD group and 27% in the control group, P = .48). These lesions were considered insignificant in all patients. There were no atrioventricular blocks, and all patients were in sinus rhythm. The cardiopulmonary bypass times were significantly higher in the TVD group than in the control group (91.6 ± 17.2 minutes versus 68.3 ± 15.7 minutes, P ≤ .01), as were the aortic cross-clamping times (50.7 ± 12.1 minutes versus 35.9 ± 14.4 minutes, P ≤ .01). CONCLUSION: Our results, along with results from other series, suggest that TVD can be used effectively and safely for closure of certain VSDs.

Umbilical catheter placement aided by coronary guidewires.

Catheterization of the umbilical vessels has proven to be an effective and relatively rapid method for gaining central vascular access in neonates. However, it can be technically difficult, the procedure may last 30 min or longer, and it can be associated with complications in some patients. We suggest using a coronary guidewire during catheterization of umbilical vessels to support the placement of umbilical catheters and significantly reduce a risk for complications. We tested the proposed technique in 6 successful ex vivo bench tests of catheterization of the umbilical vessels in stillborn piglets immediately after birth. We are confident that using coronary guidewire as a guiding tool during catheterization of the umbilical vessels is a rapid and safe method. We expect that it allows to obtain a vascular access with lower risk for dangerous procedural complications, which could be a lifesaving in critically ill patients. However, the approach needs to be validated in a comparative study in neonates.

Changes in pulmonary artery index and its relation to outcome after stage II palliation in patients with hypoplastic left heart syndrome.

OBJECTIVES: This study aimed to prove if pulmonary artery (PA) size influences survival and if an additional aortopulmonary shunt (APS) promotes left PA growth after bidirectional cavopulmonary shunt (BCPS) in patients with hypoplastic left heart syndrome. METHODS: The medical records of patients with hypoplastic left heart syndrome who underwent Norwood procedure and BCPS between 2007 and 2020 were reviewed. Right, left and total (right + left) PA indices were calculated according to Nakata and colleagues. RESULTS: A total of 158 patients were included in this study. The median age at Norwood and BCPS was 8 (7-11) days and 3.6 (3.1-4.6) months, respectively. There were 7 hospital deaths and 12 late deaths. Survival after BCPS was 90.3% at 1 year and 86.2% at 2 years. Total, right and left PA indices were 238 (195-316), 136 (101-185) and 102 (75-130) mm2/m2 at the time of BCPS, and they were 237 (198-284), 151 (123-186) and 86 (69-108) mm2/m2 at the time of Fontan. Left PA index decreased significantly between the time of BCPS and Fontan (P < 0.01). Nine patients needed partial takedown and additional APS due to failing BCPS, but the additional APS did not promote the PA growth significantly. CONCLUSIONS: Preoperative PA index did not affect the mortality after BCPS. The partial takedown and additional APS for failing BCPS were unable to improve left PA size.

Catheter interventional closure of veno-venous collaterals in cyanotic patients after partial cavopulmonary shunts in pediatric patients: clinical practice review.

The development of veno-venous collaterals is an important and treatable cause of cyanosis in patients who had undergone partial cavo-pulmonary connection (PCPC) operations. Nevertheless, the literature on this complicated therapeutic option is sparse. Patients can present cyanosis either immediately after the operation (<30 days), which delays or hinders discharge from the intensive care unit or cyanosis may occur late: (>30 days and/or in another hospital admission), after the operation. Hence, transcatheter closure of veno-venous collaterals is the treatment of choice. Four patients were selected who showed cyanosis at variable durations after PCPC; the morphology of the collaterals and their hemodynamic effect was described and the strategy for closure of such abnormal vessels is suggested. Veno-venous collaterals described in our series were seen originating mainly or mostly from innominate vein angles. The drainage sites were either above the diaphragm into a cardiac structure: the coronary sinus (CS) and/or atria; or below the diaphragm into the inferior vena cava (IVC) or hepatic veins through the paravertebral venous system and/or the azygous system. It is stated in the literature that several types of devices and coils can be used to close the collaterals such as the Amplatzer vascular plugs (AVPs), Amplatzer duct occluder II (ADOII), non-detachable and detachable coils. In this clinical review, the technical details that determine device type and size are explained. The recent generations of hydrogel-coated coils were also used in this series of patients to close the difficult types of collaterals with better results. All described vessels were closed successfully, without any complications. The patients had a significant rise in their transcutaneous oxygen saturations and hence, a clear clinical benefit.

Impact of Anatomical Sub-types and Shunt Types on Aortopulmonary Collaterals in Hypoplastic Left Heart Syndrome.

This study aims to clarify the relation of development of aortopulmonary collateral arteries (APCs) with anatomical sub-types and the shunt types at Norwood procedure in patients with hypoplastic left heart syndrome (HLHS). A total of 140 patients with HLHS who completed 3 staged palliation between 2003 and 2019 were included. Incidence of APCs and corresponding interventions were examined using angiogram by cardiac catheterization, with respect to the anatomical sub-types and shunt types. Totally, APCs were observed in 87 (62%) of the patients; pre-stage II in 32 (23%), pre-stage III in 64 (46%), and after stage III in 40 (29%). The incidence of APCs before stage II was significantly higher in patients with aortic atresia/mitral atresia (AA/MA) compared with other sub-types (P = 0.022). Patients with right ventricle to pulmonary artery conduit (RVPAC) had a higher incidence of APCs originating from the descending aorta, compared with those with modified Blalock-Taussig shunt (20% vs 2%, P= 0.002). Interventions for APCs were performed in 58 (41%) patients; before stage II in 10 (7%), after stage II in 7 (5%), before stage III in 22 (16%), and after stage III in 32 (23%). Patients with AA/MA had more interventions before stage II (P= 0.019), and patients with aortic stenosis/mitral stenosis (AS/MS) had a lower incidence of interventions after stage III (P= 0.047). More than half of the patients with HLHS developed APCs. Before stage II, patients with AA/MA sub-type had a higher incidence of APCs, and those with RVPAC had significantly more APCs from the descending aorta.

Mid-term results following pulmonary artery patch augmentation in congenital heart disease.

Background: Treatment of pulmonary artery (PA) stenosis in congenital heart disease is associated with adverse outcomes. The aim of this retrospective cohort study was to compare outcomes after surgical patch augmentation of PA stenosis in patients with biventricular congenital heart disease using different patch materials. Methods: We identified all patients from our institutional congenital heart disease database who underwent patch augmentation for PA stenosis on the main pulmonary artery (MPA) or PA branches between 2012 and 2018. Patch materials used were glutaraldehyde fixated autologous pericardium (AP), expanded polytetrafluoroethylene (ePTFE), equine pericardium (EP), and bovine pericardium (BP). The primary study endpoint was the composite of catheter-based re-intervention or re-operation to relieve recurrent stenosis at the site of prior implanted patch material. Results: A total of 156 patients (median age, 5 months, range, 0-85 months; median weight, 6.2 kg, range, 2.8-15.0 kg) underwent patch augmentation using 163 patches (ePTFE =99, 61%; EP =34, 21%; AP =25, 15%; BP =5, 3%). Overall, 131 (84%) patients underwent patch augmentation at the MPA, and 25 (16%) patients underwent patch augmentation at one or both PA branches. Over a mean follow-up period of 4±2 years, 30 patients (19%) reached the study endpoint. Freedom from primary endpoint was 92%±3% for the MPA and 25%±9% for PA branches at 5 years, respectively (P<0.001). Comparison of patch materials revealed similar re-intervention rates between ePTFE, AP, and EP. In contrast, outcomes were significantly decreased following the usage of BP when compared to other materials (ePTFE vs. BP, P=0.01; EP vs. BP, P=0.005). In the multivariable analysis, lower weight at index operation, patch augmentation of PA branches, and usage of BP were independently associated with re-intervention. Conclusions: Patch augmentation of the MPA was associated with acceptable outcomes, while patch augmentation of PA branch stenosis remained independently associated with re-intervention. None of the used patch materials demonstrated superiority; however, BP had a higher rate of re-interventions.