Procedural closure of the patent ductus arteriosus in preterm infants: a clinical practice guideline.

IMPORTANCE: Transcatheter closure of the patent ductus arteriosus (PDA) is being increasingly adopted as an alternative to surgical PDA closure in preterm infants. OBJECTIVE: To develop rigorous clinical practice guideline recommendations on procedural PDA closure in preterm infants. METHODS: The principles of the GRADE (Grading of Recommendations Assessment, Development and Evaluation) Evidence-to-Decision (EtD) framework were used to develop the guideline recommendations. An e-Delphi survey of 45 experts was conducted and recommendations that reached ≥75% agreement were accepted as consensus. MAIN RECOMMENDATIONS: Procedural PDA closure may be considered in extremely preterm infants (<28 weeks gestational age) requiring invasive mechanical ventilation >10 postnatal days and confirmed to have a large hemodynamically significant PDA, at centers with high local rates of death and/or bronchopulmonary dysplasia (conditional recommendation). If sufficient institutional expertise is available and patient characteristics are suitable, transcatheter PDA closure may be considered as the preferred approach over PDA ligation (conditional recommendation).

Patent Ductus Arteriosus Occlusion in Premature Infants.

Transcatheter ductal closure has proven to be safe and effective to occlude the patent ductus arteriosus (PDA) in premature infants. We have developed a robust multidisciplinary PDA program. After gaining experience performing transcatheter ductal closure in the cardiac catheterization laboratory, we transitioned to performing the procedure at the patient's bedside in the neonatal intensive care unit using echocardiographic guidance. The bedside approach has the potential to expand this therapy to patients who currently undergo expectant PDA management because of lack of availability of this therapy, and allow for earlier referral, which will reduce time of exposure to this pathologic shunt.

Cardiorespiratory Instability after Percutaneous Patent Ductus Arteriosus Closure: A Multicenter Cohort Study.

OBJECTIVE: To evaluate postprocedural clinical characteristics of preterm infants undergoing transcatheter patent ductus arteriosus (PDA) closure, including oxygenation/ventilation failure and cardiovascular compromise. STUDY DESIGN: Multicenter retrospective cohort study of preterm infants who were ≤2 kg at the time of percutaneous PDA closure between August 2018 and July 2021. Indices of cardiorespiratory stability were collected pre-closure, immediately post-closure, and subsequently averaged every 4 hours for the first 24 hours post-procedure. The primary outcome was incidence of post-transcatheter cardiorespiratory syndrome: composite of hemodynamic instability (defined by systemic hypotension, systemic hypertension, or use of new inotropes/vasopressors in the first 24 hours after catheterization) and at least one of the following: (i) ventilation failure or (ii) oxygenation failure. RESULTS: A total of 197 patients were included with a median [IQR] age and weight at catheterization of 34 [25, 43] days and 1090 [900, 1367] grams, respectively. The primary composite outcome of post-transcatheter cardiorespiratory syndrome was reported in 46 (23.3%). CONCLUSION: Post-transcatheter cardiorespiratory syndrome is characterized primarily by systemic hypertension and oxygenation failure, with a very low incidence of hypotension and need for inotropes.

Lessons from the Pandemic: Role of Percutaneous ECMO and Balloon Atrial Septostomy in Multi-System Inflammatory Syndrome in Children.

Multi-system inflammatory syndrome in children (MIS-C) in the setting of COVID-19 can be associated with severe cardiopulmonary dysfunction. This clinical deterioration may sometimes necessitate veno-arterial extracorporeal membrane oxygenation (VA-ECMO) support. We describe an algorithmic approach including the role of balloon atrial septostomy in this cohort. This is the first reported series of percutaneous VA-ECMO in pediatric patients with MIS-C for better outcomes. The lessons from this approach can be replicated in other pediatric clinical conditions and adds to the armament of multiple pediatric specialties.

Rescue Sternotomy in a 540†g Neonate for Right Atrial Perforation During Percutaneous Ductal Device Occlusion.

Percutaneous ductal device closure in neonates is gaining popularity. Cardiac perforation is a rare but catastrophic complication that can occur during this procedure. Surgical options to salvage this situation are limited in extremely low-weight babies. In this report, we describe one such case managed successfully and offer some suggestions to achieve a successful outcome.

3-year follow-up of a prospective, multicenter study of the Amplatzer Piccolo™ Occluder for transcatheter patent ductus arteriosus closure in children ≥ 700 grams.

OBJECTIVE: This study describes 3-year follow-up of 200 infants weighing ≥ 700 grams who underwent transcatheter patent ductus arteriosus (PDA) closure with the Amplatzer Piccolo™ Occluder. STUDY DESIGN: Between June 2017 and February 2019, 200 children were enrolled in this U.S. study (NCT03055858). PDA closure, survival, and device- or procedure-related events were evaluated. A total of 156 of the available 182 patients (86%) completed the study. RESULTS: The implant success rate was 95.5% (191/200). At 3 years, PDA closure was observed in 100% (33/33) of patients. Survival was >95% with 9 reported deaths. No deaths were adjudicated as device- or procedure-related. Notable events included aortic obstruction (2) requiring stent placement and tricuspid regurgitation (5), for which no interventions were required. CONCLUSIONS: This follow-up study demonstrates high rates of PDA closure, low serious complication rates, and survival > 95% at 3 years. The Amplatzer Piccolo™ Occluder is a safe and effective therapy for PDA treatment in premature infants. CLINICALTRIALS: gov identifier: NCT0305585.

Percutaneous Closure of the Patent Ductus Arteriosus in Infants ≤2 kg: IMPACT Registry Insights.

OBJECTIVES: Percutaneous patent ductus arteriosus (PDA) closure is becoming the standard of care for definitive closure in progressively smaller and younger neonates. The objective of this study was to assess safety and feasibility of percutaneous PDA closure in patients ≤2 kg. METHODS: This was a cohort study using the IMPACT Registry (Improving Pediatric and Adult Congenital Treatments) from the American College of Cardiology Foundation's National Cardiovascular Data Registry. Patients who were ≤2 kg at the time of percutaneous PDA closure were included. The primary outcome was the composite of technical failure and/or major adverse event. RESULTS: A total of 1587 attempted PDA closures were included, with a 3% incidence of technical failure and 5.5% incidence of the composite outcome. Major adverse events were observed in 3.8% of the patients; the most common events were device embolization requiring retrieval and unplanned cardiac or vascular surgery in 1.3% and 1.3% of cases, respectively. The incidence of the composite outcome was associated with the need for arterial access (P < .001) as well as annual hospital volume of percutaneous PDA closures in infants ≤2 kg (P = .001). The incidence of the composite outcome has decreased overtime, whereas median weight at the time of procedure has also diminished. CONCLUSIONS: Percutaneous PDA closure appears to be safe and feasible procedures in infants ≤2 kg. The incidence of major adverse events has continued to decline over the years and seems to have a strong correlation with individual center case volumes and expertise.

Strategies and techniques for percutaneous Veno-Arterial ECMO cannulation and decannulation in children.

OBJECTIVES: To describe the techniques used for percutaneous veno-arterial extracorporeal membrane oxygenation (VA-ECMO) cannulation and decannulation in children with the pediatric interventional cardiologist (PIC) as the primary operator, and present outcomes of this initial clinical experience. BACKGROUND: Percutaneous VA-ECMO during cardiopulmonary resuscitation (CPR) has been successfully performed in adults, but currently, not much data exists on children. METHODS: This is a single-center study including VA-ECMO cannulations performed by the PIC between 2019 and 2021. Efficacy was defined as the successful initiation of VA-ECMO without surgical cutdown. Safety was defined as the absence of additional procedures related to cannulation. RESULTS: Twenty-three percutaneous VA-ECMO cannulations were performed by PIC on 20 children with 100% success. Fourteen (61%) were performed during ongoing CPR, and nine for cardiogenic shock. The Median age was 15 (0.15-18) years, and the median weight was 65 (3.3-180) kg. All arterial cannulations were via the femoral artery except in one, 8-week-old infant who was cannulated in the carotid artery. A distal perfusion cannula was placed in the ipsilateral limb in 17 (78%). The median time from initiating cannulation to ECMO flow was 35 (13-112) minutes. Two patients required arterial graft placement at the time of decannulation and one needed below-knee amputation. ECMO support was maintained for a median of 4 (0.3-38) days. Thirty-day survival was 74%. CONCLUSION: Percutaneous VA-ECMO cannulations can be effectively performed, even during CPR with the Pediatric Interventional Cardiologist being the primary operator. This is an initial clinical experience. Future outcome studies compared with standard surgical cannulations are necessary to advocate routine percutaneous VA-ECMO in children.

Safety and Short-Term Outcomes for Infants < 2.5 kg Undergoing PDA Device Closure: A C3PO Registry Study.

To evaluate short-term procedural outcomes and safety for infants < 2.5 kg who underwent catheterization with intended patent ductus arteriosus (PDA) device closure in a multi-center registry, as performance of this procedure becomes widespread. A multi-center retrospective review was performed using data from the Congenital Cardiac Catheterization Project on Outcomes (C3PO) registry. Data were collected for all intended cases of PDA closure in infants < 2.5 kg from April 2019 to December 2020 at 13 participating sites. Successful device closure was defined as device placement at the conclusion of the catheterization. Procedural outcomes and adverse events (AE) were described, and associations between patient characteristics, procedural outcomes and AEs were analyzed. During the study period, 300 cases were performed with a median weight of 1.0 kg (range 0.7-2.4). Successful device closure was achieved in 98.7% of cases with a 1.7% incidence of level 4/5 AEs, including one periprocedural mortality. Neither failed device placement nor adverse events were significantly associated with patient age, weight or institutional volume. Higher incidence of adverse events associated with patients who had non-cardiac problems (p = 0.017) and cases with multiple devices attempted (p = 0.064). Transcatheter PDA closure in small infants can be performed with excellent short-term outcomes and safety across institutions with variable case volume.

A Global Perspective on PDA Management in the Extremely Premature: Shifting Trend Toward Transcatheter Closure.

Patent ductus arteriosus (PDA) is a frequently encountered defect in infants born extremely premature (≤26 weeks' gestation). Historically, closure of the PDA was performed using cyclooxygenase inhibitor medications or by surgical ligations. However, the benefits of PDA closure using these therapies have never been demonstrated, albeit studies have previously not focused on the extremely premature infants. Therefore, there was a worldwide trend toward conservative management of the PDA. With improved survival of extremely premature infants, comorbidities associated with the PDA has increased, resulting in finding alternate treatments such as transcatheter patent ductus arteriosus closure (TCPC) for this population. Currently, there is a renewed interest toward selective treatment of the PDA in this high-risk cohort of small infants. This Comprehensive Review article inspects the globally changing trends in the management of the PDA in premature infants, with a special focus on the rising adoption of TCPC. Moreover, this article compiles data from several neonatal networks worldwide to help understand the problem at hand. Understanding the current management of premature infants and their outcomes is fundamentally essential if pediatric cardiologists are to offer TCPC as a viable therapeutic option for this population. This article aims to serve as a guide for pediatric cardiologists on this topic by compiling the results on landmark clinical trials on PDA management and the controversies that arise from these trials. Comparative outcomes from several countries are presented, including interpretations and opinions of the data from experts globally. This is a step toward coming to a global consensus in PDA management in premature infants.

Use of the Medtronic Microvascular Plug 7Q for transcatheter closure of large patent ductus arteriosus in infants weighing less than 2.5 kg.

BACKGROUND: The sole Food and Drug Administration-approved device for transcatheter closure of the patent arterial duct in premature infants is indicated for patent ductus arteriosus (PDAs) ≤ 4 mm in diameter. We report a two-center experience with transcatheter closure of large PDAs (>4 mm) in infants weighing <2.5 kg using the Microvascular Plug 7Q (MVP-7Q) device. METHODS: This is a retrospective review of departmental databases and medical charts to define patient cohort and report demographic, procedural, and follow-up data. RESULTS: Twenty-two patients (12 male) with a median gestational age and birthweight of 25.5 weeks (interquartile range [IQR] = 24-28) and 800 g (572-1075), respectively, underwent attempted PDA occlusion with the MVP-7Q using a transvenous approach. The median age and weight at the time of PDA occlusion was 32 days (IQR = 24-28) and 1100 g (IQR = 960-1700), respectively. The median PDA length was 12 mm (IQR = 11-12.65). The median PDA diameters at the aortic and pulmonary ends were 5.1 (IQR = 4.9-5.5) and 4.8 mm (IQR = 4.6-5.3), respectively. Successful device occlusion was achieved in 20 patients (91%). There were two failed attempts: One due to inappropriate sizing, and the other secondary to left pulmonary artery stenosis. There were no procedural complications and no residual shunting on follow-up. CONCLUSIONS: The MVP-7Q is safe and effective for transcatheter closure of large (>4 mm) PDAs in infants <2.5 kg. The lack of retention disks may help with avoiding impingement on surrounding vessels.

Feasibility and Safety of Percutaneous Cardiac Interventions for Congenital and Acquired Heart Defects in Infants ≤1000 g.

The transcatheter closure of patent ductus arteriosus (TCPC) has been demonstrated to be feasible even in infants weighing ≤1000 g. However, other percutaneous cardiac interventions (PCI) for such small infants born with congenital heart defects (CHD) or acquired heart defects (AHD) have not been well described. The purpose of this study was to describe the feasibility and safety of PCI in infants ≤1000 g. A retrospective review was conducted between June 2015 and May 2021, looking at 148 consecutive PCIs performed on infants weighing ≤1000 g at the time of the procedure. The procedural success rate was 100%. The major adverse event (AE) rate for TCPC was 3%, while there were no major AEs for other PCI. It is feasible to perform PCIs in infants weighing ≤1000 g with CHD and AHD using currently available technologies.

Hot topics in interventional cardiology: Proceedings from the society for cardiovascular angiography and interventions (SCAI) 2021 think tank.

The Society for Cardiovascular Angiography and Interventions (SCAI) Think Tank is a collaborative venture that brings together interventional cardiologists, administrative partners, and select members of the cardiovascular industry community annually for high-level field-wide discussions. The 2021 Think Tank was organized into four parallel sessions reflective of the field of interventional cardiology: (a) coronary intervention, (b) endovascular medicine, (c) structural heart disease, and (d) congenital heart disease. Each session was moderated by a senior content expert and co-moderated by a member of SCAI's Emerging Leader Mentorship program. This document presents the proceedings to the wider cardiovascular community in order to enhance participation in this discussion, create additional dialog from a broader base, and thereby aid SCAI, the industry community and external stakeholders in developing specific action items to move these areas forward.

Consensus Guidelines for the Prevention and Management of Periprocedural Complications of Transcatheter Patent Ductus Arteriosus Closure with the Amplatzer Piccolo Occluder in Extremely Low Birth Weight Infants.

Transcatheter closure of patent ductus arteriosus (PDA) in premature infants is a feasible, safe, and an effective alternative to surgical ligation and may be performed with an implant success rate of 97%. Major procedural complications related to transcatheter PDA closure in extremely low birth weight (ELBW) infants are relatively infrequent (< 3%) ,but may be associated with a fatality if not optimally managed. Operators performing transcatheter PDA closures should be knowledgeable about these potential complications and management options. Prompt recognition and treatment are often necessary to avoid serious consequences. With strict guidelines on operator training, proctoring requirements, and technical refinements, transcatheter PDA closure in ELBW infants can be performed safely with low complication rates. This article summarizes the consensus guidelines put forward by a panel of physicians for the prevention and management of periprocedural complications of transcatheter PDA closure with the Amplatzer Piccolo Occluder in ELBW infants.

Echocardiographic versus Angiographic Measurement of the Patent Ductus Arteriosus in Extremely Low Birth Weight Infants and the Utility of Echo Guidance for Transcatheter Closure.

BACKGROUND: Transthoracic echocardiography (TTE) is increasingly utilized for guiding transcatheter closure of patent ductus arteriosus (PDA) in extremely low birth weight (ELBW) infants. The objectives of this study were to compare PDA size measurements by TTE with angiographic measurements and to describe TTE techniques used in guiding transcatheter PDA closure (TCPC) in ELBW infants. METHODS: One hundred twenty-five consecutive ELBW infants (gestational age < 27 weeks, birth weight < 1 kg) who underwent TCPC before 8 weeks of age under TTE guidance were included. Patent ductus arteriosus sizes were measured from the procedural TTE and angiograms retrospectively by blinded observers. The TTE PDA diameters at the aortic (ED1) and pulmonary end (ED2) were compared with the corresponding angiographic diameters (CD1 and CD2). The TTE PDA lengths, obtained by two techniques (EL1, a straight line between ED1 and ED2; and EL2, a curvilinear line along the PDA), were compared with the PDA length by angiography (CL). Transthoracic echocardiography was used to guide accurate device positioning within the PDA. RESULTS: The procedure weight was 600-1,460 g. The TTE and angiographic PDA diameters were comparable (mean ED1 vs CD1 = 4.5 ± 0.68 vs 4.4 ± 0.85 mm, P = .26; and mean ED2 vs CD2 = 3.1 ± 0.72 vs 3.2 ± 0.94 mm, P = .14). The angiographic length was underestimated by EL1 by 2.6 ± 1.6 mm (P < .0001), while EL2 estimated it better (mean EL2 vs CL = 11.0 ± 1.83 vs 10.8 ± 2.15 mm; P = .40). Transcatheter PDA closure was successful in 100% of the cases using TTE guidance. There were no intraprocedural complications. CONCLUSIONS: Transthoracic echocardiography guidance during TCPC in ELBW infants eliminates the need for aortograms via femoral arterial access, preventing the complications associated with it. Transthoracic echocardiography PDA measurements are comparable to angiographic measurements, thereby assisting in appropriate device size selection.

Preliminary testing and evaluation of the renata minima stent, an infant stent capable of achieving adult dimensions.

OBJECTIVES: This study sought to obtain in vivo data on a new stent and delivery system specifically designed for implantation in infants with the ability to be enlarged to adult dimensions. BACKGROUND: There are no endovascular stents designed for or approved for use in infants, nor is there a stent capable of being implanted at infant vessel diameters and achieving adult size while maintaining structural integrity. The Minima stent was designed to address these needs. METHODS: This study was performed in 6 piglets who underwent implantation of 22 Minima stents into the following locations: aorta (n = 11), branch pulmonary arteries (n = 6), and central veins (n = 5). RESULTS: Successful deployment occurred in 21/22 attempts. Two instances of post-deployment migration occurred. Stents were re-expanded at 1, 2, 3 and 5 months after implant. All stents regardless of location could be re-dilated to the intended diameter to keep pace with somatic growth (implant diameter 6.9 +/- 1.2 mm; final diameter 16.1 mm +/- 1.4 mm). Histopathology at 1 and 5 months demonstrated widely patent vessel lumens with stent apposition to vessel wall, early mild inflammatory response surrounding stent struts, typical vascular damage and healing response to acute dilation and a progressive smooth neointimal growth covering stent struts over time. CONCLUSIONS: In this in vivo study of the Minima stent, there was high implant success, predictable re-dilatability to adult diameters and favorable histopathology. Further study is warranted.

Percutaneous Stage 1 Palliation for Hypoplastic Left Heart Syndrome.

Surgical palliation for hypoplastic left heart syndrome still carries significant morbidity and mortality in neonates. We previously described a percutaneous stage 1 palliation (PS1P) in a swine experiment. Here we report the human application of the PS1P for hypoplastic left heart syndrome in the United States. The procedure is performed through a 4F sheath in the femoral vein. Bilateral pulmonary flow restrictors are implanted in the proximal branch pulmonary arteries and a stent within the ductus arteriosus. PS1P could postpone surgical repair beyond the neonatal period. It offers a simple, less invasive alternative to currently available operations for newborns with HLHS.

Hemodynamic and clinical consequences of early versus delayed closure of patent ductus arteriosus in extremely low birth weight infants.

OBJECTIVES: To describe changes in hemodynamics, respiratory support, and growth associated with transcatheter PDA closure (TCPC) in ELBW infants, stratified by postnatal age at treatment. STUDY DESIGN: This is an observational study of ELBW infants who underwent TCPC at ≤4 weeks (Group-1; n = 34), 4-8 weeks (Group-2; n = 33), and >8 weeks of age (Group-3; n = 33). Hemodynamic assessment was performed during TCPC. Multivariate Cox-proportionate-hazard modeling was used to identify factors associated with respiratory severity score (RSS) > 2 for >30 days following TCPC. RESULTS: In comparison with Group-1, Group-3 infants had higher pulmonary vascular resistance (PVRi = 3.3 vs. 1.6 WU*m2; P = 0.01), less weight gain between 4 and 8 weeks of age (16 vs. 25 g/day) and took longer to achieve RSS < 2 (median 81 vs. 20 days; P = 0.001). RSS > 2 for >30 days was associated with TCPC > 8 weeks (OR = 3.2, 95% CI: 1.75-5.8; p = 0.03) and PVRi ≥ 3 (OR = 4.5, 95% CI: 2.7-8.9; p < 0.01). CONCLUSION: ELBW infants may benefit from PDA closure within the first 4 weeks of life in order to prevent early onset pulmonary vascular disease, promote faster growth, and for quicker weaning of ventilator and oxygen support.