Aimee K. Armstrong

Objective: To describe the pregnancy and postnatal outcomes of a large, retrospectively analyzed case–cohort series of pregnancies complicated by congenital heart disease (CHD) and fetal hydrops that were assessed for potential for fetal cardiac intervention (FCI). Methods: The International Fetal Cardiac Intervention Registry (IFCIR) collects diagnostic and procedure‐related data on maternal–fetal dyads with CHD that are considered by fetal specialists to be potentially capable of benefiting from FCI, with data submitted voluntarily by local institutions. For this retrospective analysis, the IFCIR database was searched for all case entries of pregnancies with a diagnosis of CHD and coexistent non‐immune fetal hydrops, defined as abnormal fluid or edema involving at least two compartments, between January 2001 and September 2024. Data on the underlying cardiac diagnosis, procedures performed and pregnancy and postnatal outcomes were collated. Results: At the time of data extraction, the IFCIR contained 864 recorded maternal–fetal dyads, of which 91 (10.5%) had fetal hydrops at initial evaluation. Of these, 73 (80.2%) underwent FCI, including aortic ( n = 61) or pulmonary ( n = 5) balloon valvuloplasty, atrial septal intervention and/or stent placement ( n = 4) and other FCI ( n = 3), at a median gestational age of 28.3 (range, 19.6–34.7) weeks. The overall rate of procedure‐related fetal loss was 20.5% (15/73). There were an additional 10 intrauterine fetal deaths, and two cases were either terminated ( n = 1) or lost to follow‐up ( n = 1). Overall, 21 neonates were liveborn preterm (< 37 weeks) and 25 were liveborn at term (≥ 37 weeks), with a median latency post‐procedure to delivery of 8.9 (range, 0.3–18.4) weeks. Of the 73 cases that underwent FCI, 26 (35.6%) survived to first hospital discharge, including 39.3% (24/61) of patients who underwent aortic valvuloplasty, one patient who underwent atrial septal intervention and one patient who underwent pulmonary valvuloplasty. The majority of survivors had biventricular circulation (15/20 with available outcome) at the last follow‐up. No procedure‐related maternal complications were recorded. Only 1/18 patients managed expectantly without FCI survived to hospital discharge. Conclusions: Our findings suggest a potential benefit of FCI in patients with hydrops, although the procedure‐related loss rate of 1 in 5 was significant. While the survival rate was lower than that reported in non‐hydropic cohorts with FCI, approximately one‐third of hydropic fetuses that underwent FCI included in our analysis survived to hospital discharge. © 2026 International Society of Ultrasound in Obstetrics and Gynecology.

BACKGROUND: The relationship between fetal aortic valvuloplasty procedural volume and outcomes is crucial to understand whether regionalization should be advised worldwide. This study utilizes the International Fetal Cardiac Intervention Registry to examine the relationship between center volume for fetal aortic valvuloplasty and outcome metrics including procedure success, complications, and fetal death. METHODS: Data were included from institutions performing ≥3 procedures (2001–2018). The primary outcome was technical success, defined as ≥1 balloon inflation across the aortic valve, with increased antegrade flow across the valve and new aortic regurgitation. Secondary end points were procedural complications and fetal periprocedural death (within 48 hours). Univariable and Classification and Regression Tree analyses were performed. RESULTS: Eleven centers, with volumes ranging from 6 to 31 cases, performed 162 fetal aortic valvuloplasties with a technical success rate of 80.2%. Higher volume was not associated with better technical success or fewer complications but was associated with fewer periprocedural fetal deaths. Employing Classification and Regression Tree modeling, the largest drivers of improved outcomes for all measures were greater estimated fetal weight and gestational age. A single cardiac puncture was associated with greater technical success and fewer procedural complications after accounting for fetal estimated fetal weight and gestational age. CONCLUSIONS: In this registry cohort, higher-volume centers did not have greater fetal aortic valvuloplasty technical success or fewer complications but did have fewer periprocedural fetal deaths. Fetal gestational age and number of cardiac punctures influenced outcomes, suggesting that unmeasured fetal selection criteria, such as different referral patterns, and technical expertise, indicative of overall center/team experience, may influence fetal survival.

BACKGROUND: The Alterra Adaptive Prestent provides a landing zone for implantation of the 29 mm SAPIEN 3 transcatheter heart valve (THV) in patients with a dysfunctional right ventricular outflow tract (RVOT) to treat pulmonary regurgitation (PR). Here, we report 3-year outcomes from a pooled analysis of patients who underwent Alterra/SAPIEN 3 THV implantation enrolled in the ALTERRA pivotal trial, Continued Access Protocol, and Pulmonic Delivery System Registry. METHODS: This multicenter, prospective trial enrolled patients with moderate or greater PR and RVOT/pulmonary valve anatomy suitable for implantation. The nonhierarchical composite end point of THV dysfunction was examined at 6 months: RVOT/pulmonary valve reintervention, moderate or greater PR, and mean RVOT/pulmonary valve gradient ≥35 mm Hg. Individual components of the composite, as well as additional clinical and echocardiographic outcomes were examined up to 3 years. RESULTS: The Alterra/SAPIEN 3 THV system was implanted in 118 patients at 14 sites. At 6 months, THV dysfunction was 3.5% (4/113). At 3 years, 97.3% of patients in the valve implant population had freedom from reintervention, 100% of patients had a mean RVOT/pulmonary valve gradients <35 mm Hg, and 93.3% of patients had mild or lesser total PR. The Kaplan-Meier estimate of all-cause mortality was 3.5% at 3 years. There were no cases of coronary artery compression, hemopericardium, or endocarditis. CONCLUSIONS: This analysis reports the longest follow-up in the largest cohort of patients from the ALTERRA trials. The Alterra Adaptive Prestent with the SAPIEN 3 THV system has shown excellent procedural outcomes and is effective in reducing PR at 3-year follow-up. REGISTRATION: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT03130777.

Background: Infective endocarditis is a leading cause of morbidity and mortality in children and adolescents with underlying CHD. Appropriate diagnostic workup and management in the inpatient setting can be challenging in this patient population due to the spectrum of disease complexity and the dynamic nature of the field. Therefore, the Paediatric Acute Care Cardiology Collaborative has undertaken the creation of this clinical practice guideline. Methods: A panel of paediatric cardiologists, infectious disease specialists, intensivists, advanced practice practitioners, pharmacists, cardiothoracic surgeons, and a dentist was convened. The literature was systematically reviewed for relevant articles on the management of infective endocarditis in patients with CHD. Using the modified Delphi technique, recommendations were generated and put through iterative Delphi rounds to achieve consensus for inclusion. Results: Based on 127 articles that met the inclusion criteria, 82 recommendations were generated, 50 of which achieved consensus for inclusion and are included in this guideline. They address risk factors specific to CHD lesion type and prior interventions including implanted material, diagnostic considerations, management strategies, and recommendations on counselling other healthcare providers, patients, and families. Of the 50 consensus recommendations, 36 are strong recommendations, though 20 have low or very low quality of evidence. Conclusions: A central theme in this guideline is that an individual’s specific CHD lesion and prior interventions must be carefully considered for risk stratification, diagnostic approach, and management. While most are strong recommendations, many are supported by low quality of evidence, emphasising the need for further research in this subject.

BACKGROUND: The Minima Stent System is the first stent designed, tested, and Food and Drug Administration–approved for use in neonates, infants, and children. Our objective was to evaluate the safety and efficacy of Minima implantation for pulmonary artery stenosis (PAS) and coarctation of the aorta (CoA). METHODS: Multicenter, single-arm, prospective, nonrandomized trial. Primary end points included stenosis relief, freedom from device-related serious adverse events or surgical intervention through 6 months, and maintenance of vessel lumen diameter on computed tomography or catheter angiography at 6 months. RESULTS: Forty-two patients (21 PAS, 15 recurrent CoA, and 6 native CoA) underwent Minima implantation at a median age and weight of 9 (range, 0.4–112) months and 7.8 (3.4–28.3) kg. Implantation was successful in 41 (97.6%) and resulted in a median increase in minimal vessel diameter of 131% (46%–483%) and reduction in median pressure gradients from 25 (0–63) to 0 (0–6; P <0.001) mm Hg in patients with CoA. Two acute PAS stent embolizations occurred; both stents were secured in the contralateral PA, and one was treated with an additional Minima stent. Seven patients with CoA, all under 6 kg, experienced transient femoral artery thrombosis. At 6 months, there were no explants or device-related serious adverse events. Luminal diameter was maintained at 89% (59%–137%) of the implant diameter. During a median follow-up of 596 (412–979) days, 13 (31%; 7 CoA and 6 PAS) patients underwent planned stent expansion without complications. CONCLUSIONS: The Minima system is safe and effective for treating PAS and CoA in infants and small pediatric patients. Luminal patency was preserved, and planned reinterventions for somatic growth seem well-tolerated in early follow-up. REGISTRATION: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT05086016.

Background The Minima Stent System is the first stent designed, tested, and FDA-approved for use in neonates, infants, and children. Our objective was to evaluate the safety and efficacy of Minima implantation for pulmonary artery stenosis (PAS) and coarctation of the aorta (CoA). Methods Multicenter, single-arm, prospective, non-randomized trial. Primary endpoints included stenosis relief, freedom from device-related serious adverse events (SAEs) or surgical intervention through 6-months, and maintenance of vessel lumen diameter on computed tomography or catheter angiography at 6-months. Results Forty-two patients (21 PAS, 15 recurrent CoA, 6 native CoA) underwent Minima implantation at a median age and weight of 9 (range 0.4-112) months and 7.8 (3.4-28.3) kg. Implantation was successful in 41 (97.6%) and resulted in a median increase in minimal vessel diameter of 131% (46-483%) and reduction in median pressure gradients from 25 (0-63) mmHg to 0 (0-6;pConclusions The Minima system is safe and effective for treating PAS and CoA in infants and small pediatric patients. Luminal patency was preserved, and planned re-interventions for somatic growth seem well tolerated in early follow-up. What Is Known?Endovascular stent therapy for infants and small children with congenital heart disease has remained highly challenging due to a dearth of available tools specifically designed, tested, and approved for use in this unique population. What the Study Adds. The Minima Stent System, specifically designed for infants and small children, has demonstrated safety and effectiveness in treating both native and post-surgical coarctation of the aorta and pulmonary artery stenosis in this population. On follow-up imaging, vessel patency and caliber were well-preserved, and further elective expansion of the stent to accommodate somatic growth was well-tolerated. Additional follow-up of the current cohort and other post-approval implants is needed to better understand the long-term performance of the Minima stent as patients approach adult size.

Background: Procedure duration is an important predictor of patient outcomes in surgery. However, the relationship between procedure duration and adverse events in congenital cardiac catheterization is largely unexplored.Methods: All cases entered into the Congenital Cardiac Catheterization Project on Outcomes from 2014 to 2017 were included. Cases were ordered from shortest to longest case length, minus time spent managing adverse events, for each case type. The outcomes, Level 3bc/4/5 and 4/5 adverse event rates, were calculated for cases above and below the 75^th percentile for case length. To identify an independent relationship between case length and outcomes, the case length percentile was added to the CHARM II risk model.Results: Among 14,704 catheterizations, longer cases (>75^th percentile for case length) had Level 4/5 rates that were 2.2% and 2.7% compared to cases ≤75^th percentile with adverse event rates of 0.9% and 1.4% for diagnostic and interventional cases, respectively. Level 3bc/4/5 rates were 5.0% and 8.4% in longer cases compared to 2.4% and 5.4% for diagnostic and interventional cases, respectively. After adding case length to the CHARM II risk model, case length 50^th–75^th percentile had an odds ratio (OR) of 1.4, 75^th–90^th percentile an OR of 1.56, and >90^th percentile an OR of 2.24 as compared to cases with case length th percentile (p ≤ 0.001 for all).Conclusions: Longer case lengths are associated with clinically important and life-threatening adverse events in congenital cardiac catheterization, even after accounting for known risk factors. Case length may be an important target for future quality improvement work.