Transcatheter Hepatic Conduit-Azygous Vein Connection Reduces Pulmonary Arteriovenous Malformations in a Cyanotic Fontan Patient.

The authors report a closed-chest, transcatheter large-vessel connection (hepatic conduit to azygous vein) to reverse pulmonary arteriovenous malformations in a 10-year-old patient after Fontan for heterotaxy/interrupted inferior vena cava, with an increase in oxygen saturation from 78% to 96%. Computational fluid dynamics estimated a 14-fold increase in hepatic blood flow to the left pulmonary artery (from 1.3% to 14%). (Level of Difficulty: Advanced.).

Selective Use of Pulmonary Vasodilators in Patients with Fontan Physiology.

Background: Fontan-associated liver disease is a well-known sequela following the Fontan procedure for patients living with single-ventricle heart disease. Pulmonary vasodilators, such as phosphodiesterase type 5 inhibitors, have emerged as a potential therapeutic option for lowering central venous pressures by reducing pulmonary vascular resistance. Method: We performed a single-center retrospective review of Fontan patients who were placed on pulmonary vasodilator therapy with prehemodynamic and posthemodynamic, MR elastography, and histologic assessments. Results: A total of 125 patients with Fontan circulation underwent surveillance with cardiac catheterization during the review period. Fifty-three (42%) patients who did not have increased end-diastolic pressures at the time of cardiac catheterization were started on phosphodiesterase type 5 inhibitor therapy. Nine patients (17%) underwent posttherapy follow-up catheterization. The mean Fontan pressure decreased from 15.4 ± 3.3 mmHg to 13.3 ± 2.5 mmHg (p=0.026), after initiation of pulmonary vasodilatory therapy. There was no change in end-diastolic pressure, transpulmonary gradient, wedge pressure, pulmonary vascular resistance, cardiac index, or saturation. Eleven patients (21%) underwent pretherapy MR elastography testing with posttherapy follow-up MR elastography. We found no improvement in liver stiffness score following the application of pulmonary vasodilators. Three patients underwent pretherapy and posttherapy liver biopsies, with variable histological changes observed within the hepatic parenchyma. Conclusions: These data demonstrate indeterminate results for the selective use of pulmonary vasodilators but highlight the need for large prospective randomized control trials of pulmonary vasodilator therapies to fully assess the benefit of such therapies in Fontan-associated liver disease.

Pulmonary Atresia With Intact Ventricular Septum: From Radiofrequency Perforation to Transcatheter Pulmonary Valve.

OBJECTIVES: We intend to describe an entirely transcatheter management pathway for patients with pulmonary atresia with intact ventricular septum (PA/IVS). BACKGROUND: PA/IVS is a rare cyanotic congenital heart lesion traditionally palliated with multiple procedures and surgeries. Entirely non-surgical transcatheter management from infancy to adulthood may be possible; however, the pathway from neonatal radiofrequency (RF) pulmonary valve perforation to later transcatheter pulmonary valve replacement (TPV) is not well described. METHODS: This retrospective study was performed at a pediatric cardiac center between 2007-2018. All patients with PA/IVS who were managed exclusively with catheterization-based interventions as neonates (RF perforation, pulmonary valvuloplasty, or ductal stenting) were analyzed. Demographic, procedural and clinical data were collected. RESULTS: Fifteen patients had exclusively catheterization-based RV decompression as neonates, 7 of whom did not require subsequent surgery. Six patients required a right ventricular outflow tract (RVOT) augmentation later in life; all were born before 2013. All 6 later had a TPV placed. Two of the patients underwent a surgical Glenn shunt alone. Of the 7 patients that never had surgery, 3 have since undergone a TPV, and 4 are awaiting candidacy for TPV placement. No patients with PA/IVS have had an RVOT augmentation at our institution since 2012. CONCLUSIONS: Patients with PA/IVS who undergo catheterization-based neonatal interventions can make it to TPV without requiring surgery. At our institution, there has been a shift in management over the last 8 years favoring entirely non-surgical transcatheter management from infancy to adulthood.

Institutional Trend in Device Selection for Transcatheter PDA Closure in Premature Infants.

We report our experience with transcatheter patent ductus arteriosus (PDA) closure in premature infants and compare patients grouped by the device used for closure: the Microvascular Plug, "MVP" (Medtronic, Minneapolis, MN); Micro Plug Set, "Micro Plug" (KA Medical, Minneapolis, MN); and Amplatzer Piccolo Occluder, "Piccolo" (Abbot, Santa Clara, CA). We also report trends in device selection over time. Studies examining outcomes according to device selection for PDA closure in premature infants are lacking. We performed a retrospective review of all percutaneous PDA closures in premature infants at a single center (June 2018-May 2021). Patients were grouped by initial device selected for PDA closure (intention to treat). Institutional Review Board approval was obtained. 58 premature infants [MVP (n = 25), Micro Plug (n = 25), and Piccolo (n = 8)] underwent successful transcatheter PDA closure (mean gestational age 27 weeks 2 days; mean weight at procedure 1.4 kg; mean age at procedure 28 days). Pre-procedural demographics, procedural data, and follow-up data were similar between groups. There were no significant procedural adverse events. Three devices (2 MVP, 0 Micro Plug, 1 Piccolo p = 0.27) embolized after the procedure. One other device was removed for concern for aortic obstruction. Device selection evolved with a clear trend toward the Micro Plug device over time. Demographic, procedural, and follow-up data were similar between the MVP, Micro Plug, and Piccolo groups. The Micro Plug did not require exchange for suboptimal fitting or embolize and became our preferred device in most cases.

Purpose-Built Transcatheter Cavopulmonary Anastomosis Device Requirements: Multi-Modality Imaging Evaluation.

BACKGROUND/PURPOSE: Patients with a functional single ventricle undergo multiple, palliative open-heart surgeries. This includes a superior cavopulmonary anastomosis or bidirectional Glenn shunt. A less-invasive transcatheter approach may reduce morbidity. METHODS/MATERIALS: We analyzed pre-Glenn X-ray contrast angiography (XA), cardiac computed tomography (CT), and cardiac magnetic resonance (CMR) studies. RESULTS: Over an eleven-year period (1/2007 - 6/2017), 139 Glenn surgeries were performed at our institution. The typical age range at surgery was 59 - 371 days (median = 163; IQR = 138 - 203). Eight-nine XA, ten CT, and ten CMR studies obtained from these patients were analyzed. Cephalad SVC measurements (millimeters) were 7.3 ± 1.7 (XA), 7.7 ± 1.6 (CT) and 6.9 ± 1.8 (CMR). RPA measurements were 7.3 ± 1.9 (XA), 7.4 ± 1.6 (CT) and 6.6 ± 1.9 (CMR). Potential device lengths were 10.9 ± 6 - 17.4 ± 6.4 (XA), 10.1 ± 2.1 - 17.7 ± 2.4 (CT) and 17.3 ± 4. - 23.7 ± 5.5 (CMR). SVC-RPA angle (degrees) was 132.9 ± 13.2 (CT) and 140 ± 10.2 (MRI). Image quality of all CT (100%), almost all XA (SVC 100%, RPA 99%), and most MRI (SVC 80%, RPA 90%) were deemed sufficient. Parametric modeling virtual fit device with 10 mm diameter and 20 - 25 mm length was ideal. CONCLUSIONS: Ideal transcatheter cavopulmonary shunt device for the typical patient would be 10 mm in diameter and 20-25 mm in length.

Selective Valve Removal for Melody Valve Endocarditis: Practice Variations in a Multicenter Experience.

Guidelines for management of Melody transcatheter pulmonary valve (TPV) infective endocarditis (IE) are lacking. We aimed to identify factors associated with surgical valve removal versus antimicrobial therapy in Melody TPV IE. Multicenter retrospective analysis of all patients receiving Melody TPV from 10/2010 to 3/2019 was performed to identify cases of IE. Surgical explants versus non-surgical cases were compared. Of the 663 Melody TPV implants, there were 66 cases of IE in 59 patients (59/663, 8.8%). 39/66 (59%) were treated with IV antimicrobials and 27/66(41%) underwent valve explantation. 26/59 patients (44%) were treated medically without explantation or recurrence with average follow-up time of 3.5 years (range:1-9). 32% of Streptococcus cases, 53% of MSSA, and all MRSA cases were explanted. 2 of the 4 deaths had MSSA. CART analysis demonstrated two important parameters associated with explantation: a peak echo gradient ≥ 47 mmHg at IE diagnosis(OR 10.6, p < 0.001) and a peak echo gradient increase of > 24 mmHg compared to baseline (OR 6.7, p = 0.01). Rates of explantation varied by institution (27 to 64%). In our multicenter experience, 44% of patients with Melody IE were successfully medically treated without valve explantation or recurrence. The degree of valve stenosis at time of IE diagnosis was strongly associated with explantation. Rates of explantation varied significantly among the institutions.

Intravascular Ultrasound (IVUS) Provides the Filling for the Angiogram's Crust: Benefits of IVUS in Pediatric Interventional Cardiology.

BACKGROUND: Intravascular ultrasound (IVUS) is a catheter-based imaging modality that generates cross-sectional views of vessel walls and lumens. This technique is used in adult interventional and vascular surgeries to guide the management of coronary artery and peripheral arterial disease. IVUS has been described as superior to angiography in providing data about lesions of interest, including degree of vessel stenosis and stent apposition following intervention. IVUS use to guide transcatheter management of congenital heart disease is limited. OBJECTIVE: We reviewed our experience using IVUS as an adjunctive tool to diagnose lesions and assess intervention in pediatric patients during cardiac catheterization. METHODS AND RESULTS: A retrospective chart review of all pediatric patients who underwent IVUS during cardiac catheterization to evaluate the cross-sectional lumen of non-coronary vessel(s) at Rady Children's Hospital from January 2018 to December 2019 was performed. Median patient age was 637 days (range, 44-4328 days), with mean weight of 12.1 ± 9 kg. Twenty-six vessels were interrogated with IVUS (pulmonary venous stenosis [n = 8], coarctation [n = 5], branch pulmonary artery stenosis [n = 6], systemic shunts and conduits [n = 3], and other peripheral vasculature [n = 4]). IVUS added value in all cases (100%). We found that IVUS guided the intervention in 88% of procedures and defined the endpoint in 62% of transcatheter interventions. There were no IVUS-related complications. CONCLUSIONS: IVUS enhanced our diagnostic interpretation and identified occult lesions not visualized by angiography. IVUS was valuable in guiding and defining the endpoints of these interventions.

Expanded Use of the One-Step Technique for Simultaneous Landing Zone Stenting and Placement of the Melody Transcatheter Pulmonary Valve.

OBJECTIVES: We report a multicenter experience with simultaneous right ventricular outflow tract (RVOT) stenting and transcatheter pulmonary valve implantation using the Melody valve (Medtronic). BACKGROUND: Prestenting the RVOT before Melody valve implantation is now the standard of care. Prestenting is usually performed as a separate step. The "one-step" technique for simultaneous landing zone stenting and Melody delivery was previously reported using only Max LD stents (Medtronic). We report a multicenter experience of simultaneous stenting and Melody implantation using multiple stent types in combination. METHODS: This retrospective cohort study includes 33 patients from 3 centers who underwent simultaneous stenting and Melody valve implantation between 2017 and 2020. Key variables were compared with 31 patients from the same centers who underwent standard (non-simultaneous) prestenting followed by Melody implantation during the same time frame. RESULTS: The 2 groups were similar in terms of age, weight, sex, and total procedure time. The 2 groups had similar clinical results and safety profiles, with no difference between the postimplantation right ventricle (RV) to pulmonary artery systolic pressure gradient, RV to aortic pressure ratio, and complication rate. The simultaneous group had lower radiation exposure as measured by dose area product. Up to 3 stents were safely placed simultaneously with a Melody valve. CONCLUSIONS: Simultaneous RVOT stenting and Melody valve implantation can safely be used to place up to 3 stents outside a Melody valve. This approach can simplify the catheterization procedure and potentially reduce radiation dose.

4D Flow MRI Quantification of Congenital Shunts: Comparison to Invasive Catheterization.

PURPOSE: To compare invasive right heart catheterization with four-dimensional (4D) flow MRI for estimating shunt fraction in patients with intracardiac and extracardiac shunts. MATERIALS AND METHODS: In this retrospective study, patients who underwent 4D flow MRI and invasive right heart catheterization with a shunt run between August 2015 and November 2018 were included. The primary objective was comparison of estimated shunt fraction (ratio of pulmonary-to-systemic flow, Qp/Qs) at 4D flow and catheterization. Secondary objectives included comparison of the right ventricular-to-left ventricular stroke volume ratio (RVSV/LVSV) to shunt fraction (for those with applicable shunts) and comparison of cardiac output between 4D flow and catheterization. Statistical analysis included Pearson correlation and Bland-Altman plots. RESULTS: A total of 33 patients met inclusion criteria (mean age, 49 years ± 16 [standard deviation]; 24 women). 4D flow measurements of Qp/Qs strongly correlated with those at catheterization (r = 0.938), and there was no bias. RVSV/LVSV correlated strongly with Qp/Qs from 4D flow (r = 0.852) and catheterization (r = 0.842). Measurements of left ventricle (Qs) and right ventricle (QP) cardiac output from 4D flow and catheterization (Fick) correlated moderately overall (r = 0.673 [Qp] and r = 0.750 [Qs]). CONCLUSION: Shunt fraction measurement using 4D flow MRI compares well with that using invasive cardiac catheterization.Supplemental material is available for this article.© RSNA, 2021.

Bronchial stenting in infants with severe bronchomalacia: Technique and outcomes.

OBJECTIVES: To report the first use of a balloon expandable bare metal stent for treating infant bronchomalacia. BACKGROUND: Infant bronchomalacia often requires prolonged mechanical ventilation and can be life-threatening. Effective treatment for severe infant bronchomalacia continues to be elusive. We present three cases of bronchial stenting for no-option or treatment refractory infant bronchomalacia. METHODS: Three consecutive cases of stenting to relieve conservative treatment refractory severe infant bronchomalacia were performed between February 2019 and December 2020. Initial diagnosis was confirmed with Computed Tomography (CT) angiography. Patients underwent rigid micro laryngoscopy, bronchoscopy, and flexible bronchoscopy to evaluate the airway. Initial conservative management strategies were pursued. Patients failing initial conservative management strategies were considered for rescue bronchial stenting. RESULTS: Our initial clinical experience with a coronary bare metal stent for these procedures has been favorable. The stent was easy to deploy with precision. We did not encounter stent embolization or migration. There was sufficient stent radial strength to relieve bronchomalacia without causing restenosis or erosion. There was no significant granulation tissue formation. In one patient, the stent was removed after 12 months of somatic growth; this was uneventful and bronchial patency was maintained. There were no complications in any of our patients regarding stent placement and reliability. CONCLUSION: In cases of three infants with severe bronchomalacia, we found that bronchial stenting with the bare metal coronary stent was effective in relieving bronchial stenosis.

Patent Ductus Arteriosus Stenting for All Ductal-Dependent Cyanotic Infants: Waning Use of Blalock-Taussig Shunts.

[Figure: see text].

Infants with pulmonary atresia intact ventricular septum who require balloon atrial septostomy have significantly higher 18-month mortality.

INTRODUCTION: Many newborns with pulmonary atresia/intact ventricular septum require intervention to establish pulmonary flow and sufficient cardiac output. The resulting haemodynamic changes are not well characterised and may have unintended consequences. METHODS: This is a 30-year (1988-2018) retrospective study of patients with pulmonary atresia intact ventricular septum. RESULTS: Eighty-nine patients were included, and median follow-up was 8 years. Fifty-five per cent had coronary sinusoids and 27% had right ventricular-dependent coronary circulation. Most patients were managed with surgical aortopulmonary or modified Blalock-Taussig shunt (73%), and 12 patients underwent balloon atrial septostomy before surgical intervention. The remaining patients (27%) underwent only transcatheter interventions; 7 required an atrial septostomy and 17 required ductal stentings. All-cause mortality was 10%, most deaths (89%) occurred before 18 months of age. Of these early deaths, 87% required a balloon atrial septostomy and 85% had right ventricular-dependent coronary sinusoids. Eighteen-month mortality was significantly higher for patients who required a balloon atrial septostomy compared to those who did not (36% versus 1.4% p < 0.0001). DISCUSSION: Patients with pulmonary atresia/intact ventricular septum who require balloon atrial septostomy in the newborn period have significantly higher 18-month mortality. Quantifying the mortality difference may help guide prognostication and expectation setting. Infants who had septostomy and a surgical shunt in the newborn period fared better than those who only underwent septostomy (even when accompanied by ductal stenting). For infants with right ventricular-dependent circulation, atrial septostomy should only be performed on an urgent or emergent basis and these patients should be considered for early surgical intervention and neonatal transplant.

Abnormal pulmonary perfusion heterogeneity in patients with Fontan circulation and pulmonary arterial hypertension.

KEY POINTS: The distribution of pulmonary perfusion is affected by gravity, vascular branching structure and active regulatory mechanisms, which may be disrupted by cardiopulmonary disease, but this is not well studied, particularly in rare conditions. We evaluated pulmonary perfusion in patients who had undergone Fontan procedure, patients with pulmonary arterial hypertension (PAH) and two groups of controls using a proton magnetic resonance imaging technique, arterial spin labelling to measure perfusion. Heterogeneity was assessed by the relative dispersion (SD/mean) and gravitational gradients. Gravitational gradients were similar between all groups, but heterogeneity was significantly increased in both patient groups compared to controls and persisted after removing contributions from large blood vessels and gravitational gradients. Patients with Fontan physiology and patients with PAH have increased pulmonary perfusion heterogeneity that is not explainable by differences in mean perfusion, gravitational gradients, or large vessel anatomy. This probably reflects vascular remodelling in PAH and possibly in Fontan physiology. ABSTRACT: Many factors affect the distribution of pulmonary perfusion, which may be disrupted by cardiopulmonary disease, but this is not well studied, particularly in rare conditions. An example is following the Fontan procedure, where pulmonary perfusion is passive, and heterogeneity may be increased because of the underlying pathophysiology leading to Fontan palliation, remodelling, or increased gravitational gradients from low flow. Another is pulmonary arterial hypertension (PAH), where gravitational gradients may be reduced secondary to high pressures, but remodelling may increase perfusion heterogeneity. We evaluated regional pulmonary perfusion in Fontan patients (n = 5), healthy young controls (Fontan control, n = 5), patients with PAH (n = 6) and healthy older controls (PAH control) using proton magnetic resonance imaging. Regional perfusion was measured using arterial spin labelling. Heterogeneity was assessed by the relative dispersion (SD/mean) and gravitational gradients. Mean perfusion was similar (Fontan = 2.50 ± 1.02 ml min-1  ml-1 ; Fontan control = 3.09 ± 0.58, PAH = 3.63 ± 1.95; PAH control = 3.98 ± 0.91, P = 0.26), and the slopes of gravitational gradients were not different (Fontan = -0.23 ± 0.09 ml min-1  ml-1  cm-1 ; Fontan control = -0.29 ± 0.23, PAH = -0.27 ± 0.09, PAH control = -0.25 ± 0.18, P = 0.91) between groups. Perfusion relative dispersion was greater in both Fontan and PAH than controls (Fontan = 1.46 ± 0.18; Fontan control = 0.99 ± 0.21, P = 0.005; PAH = 1.22 ± 0.27, PAH control = 0.91 ± 0.12, P = 0.02) but similar between patient groups (P = 0.13). These findings persisted after removing contributions from large blood vessels and gravitational gradients (all P < 0.05). We conclude that patients with Fontan physiology and PAH have increased pulmonary perfusion heterogeneity that is not explained by differences in mean perfusion, gravitational gradients, or large vessel anatomy. This probably reflects the effects of remodelling in PAH and possibly in Fontan physiology.

Transjugular liver biopsy for Fontan associated liver disease surveillance: Technique, outcomes and hemodynamic correlation.

BACKGROUND: Fontan associated liver disease (FALD) is attributed to the limitations of the Fontan circulation, resulting in congestive hepatopathy. The technique and outcomes of transjugular liver biopsies (TJLB) in Fontan patients warrant definition as part of a rigorous FALD surveillance program. METHOD: Four year review of patients with Fontan physiology who underwent a TJLB during surveillance catheterizations. Biopsy site, technique, histology, angiography, hemodynamics, and complications were reviewed to assess correlation of biopsy scores with simultaneously obtained catheterization hemodynamics. RESULTS: 125 patients with a TJLB from 10/1/14 to 5/1/18. Median age 17 years (2-50.5). Technical success 100% (125/125), all samples diagnostic. 17% (21) accessed via the left internal jugular vein, secondary to right IJ occlusion or Heterotaxy syndrome. No patients had superior compartment obstruction preventing transjugular approach. 3.2% complication rate (4/125). Complications were early in the experience, including capsular perforation (2), renal hematoma (1) and hemobilia (1), all without long-term effect and all avoidable. After standardized entry/exit angiography was adopted, no further complications noted. There is a significant correlation between the newly described modified Ishak congestive hepatic fibrosis (ICHF) score with mean Fontan pressure, time from Fontan and cardiac index. CONCLUSIONS: TJLB is an alternate method for obtaining critical FALD surveillance data, with lower complication rates that traditional techniques. Vascular anomalies in Fontan physiology appear common and warrant pre-biopsy assessment. There is a significant correlation between biopsy score, time from Fontan, mean Fontan pressure and cardiac index.

An Elusive Prize: Transcutaneous Near InfraRed Spectroscopy (NIRS) Monitoring of the Liver.

Introduction: We postulate a relationship between a transcutaneous hepatic NIRS measurement and a directly obtained hepatic vein saturation. If true, hepatic NIRS monitoring (in conjunction with the current dual-site cerebral-renal NIRS paradigm) might increase the sensitivity for detecting shock since regional oxygen delivery changes in the splanchnic circulation before the kidney or brain. We explored a reliable technique for hepatic NIRS monitoring as a prelude to rigorously testing this hypothesis. This proof-of-concept study aimed to validate hepatic NIRS monitoring by comparing hepatic NIRS measurements to direct hepatic vein samples obtained during cardiac catheterization. Method: IRB-approved prospective pilot study of hepatic NIRS monitoring involving 10 patients without liver disease who were already undergoing elective cardiac catheterization. We placed a NIRS monitor on the skin overlying liver during catheterization. Direct measurement of hepatic vein oxygen saturation during the case compared with simultaneous hepatic NIRS measurement. Results: There was no correlation between the Hepatic NIRS values and the directly measured hepatic vein saturation (R = -0.035; P = 0.9238). However, the Hepatic NIRS values correlated with the cardiac output (R = 0.808; P = 0.0047), the systolic arterial blood pressure (R = 0.739; P = 0.0146), and the diastolic arterial blood pressure (R = 0.7548; P = 0.0116). Conclusions: Using the technique described, hepatic NIRS does not correlate well with the hepatic vein saturation. Further optimization of the technique might provide a better measurement. Hepatic NIRS does correlate with cardiac output and thus may still provide a valuable additional piece of hemodynamic information when combined with other non-invasive monitoring.

Serial Dilation of Low-Profile Stents Delivered in the Aorta and Pulmonary Arteries in Pediatric Patients Leads to Spontaneous Fractures but Not to Adverse Events.

OBJECTIVES: Low-profile stents placed in pediatric patients with congenital heart disease must be expanded by balloon angioplasty to accommodate patient growth. During the process of serial dilation, some stents may spontaneously fracture. The incidence and safety profile of spontaneous fracture is unclear. We report the performance characteristics and safety profile of a cohort of low-profile, premounted stents placed in the pulmonary arteries and aorta and then serially dilated over time to accommodate patient growth, including incidence of fracture and any adverse events. METHODS: A retrospective chart review was conducted of 25 pediatric patients who underwent 27 stent placements with low-profile, premounted stents from January 2005 to September 2018. RESULTS: Nine stents (33%) sustained a spontaneous fracture. There was no statistically significant association between stent fracture and our variables of interest, ie, patient gender, patient weight at time of original stenting, stent location (aorta vs pulmonary artery), stent type, original diameter of stent, and weight at the time of stent implantation. There was no association between time to spontaneous fracture and the aforementioned variables of interest. The majority of the spontaneous fractures occurred within the first 4 years after stent implantation, and there was no difference in survival between the 3 stent types investigated in our cohort. CONCLUSION: One-third of stents undergoing serial dilation for patient growth fractured spontaneously. Patients with fractured stents were free from significant adverse events in this cohort.

Alternative Access in Congenital Heart Disease.

Limited arterial vascular access precluded necessary transcatheter intervention in a 22-year-old woman with repaired interrupted aortic arch type B. Alternative transcaval vascular access enabled percutaneous therapy. This practice evolution is likely to benefit the growing numbers of adults with congenital heart disease. (Level of Difficulty: Advanced.).

Early experience with the Micro Plug Set for preterm patent ductus arteriosus closure.

OBJECTIVES: We intend to describe early experience using a new, commercially available Micro Plug Set for preterm neonate and infant transcatheter patent ductus arteriosus (PDA) occlusion. BACKGROUND: Transcatheter PDA occlusion in premature neonates and small infants is safe and effective. The procedure is early in its evolution. METHODS: Procedural and short-term outcomes of preterm neonates and infants undergoing transcatheter PDA occlusion with a new, commercially available device were reviewed. RESULTS: Eight preterm neonates and infants born at median 27 weeks gestation (23-36 weeks) underwent transcatheter PDA device closure with the Micro Plug Set. The device is short (2.5 mm) with a range of diameters (3, 4, 5, 6 mm) and delivered through a microcatheter. Procedures were performed at median 41 days of age (12-88 days) and at 1690 g (760-3,310 g). Transvenous PDA device occlusion was performed with fluoroscopic and echocardiography guidance. All procedures were successful with complete PDA occlusion. There were no procedural or short-term adverse events. CONCLUSIONS: Preterm neonate and infant transcatheter PDA device closure with a new, commercially available short and microcatheter delivered device (Micro Plug Set) was safe and effective in a small, early series of patients.

Radiation Risk Categories in Cardiac Catheterization for Congenital Heart Disease: A Tool to Aid in the Evaluation of Radiation Outcomes.

To stratify diverse procedure types into categories with similar radiation exposure in cardiac catheterization for congenital heart disease. Radiation exposures for a comprehensive list of specific procedure types and stratification of outcomes based on radiation risk are not currently available. Data between January 2014 and December 2015 were collected on all cases performed at sites participating in C3PO-QI (Congenital Cardiac Catheterization Outcomes Project-Quality Improvement Initiative) and 9 centers were included. Using expert consensus, 40 unique procedure types were defined by diagnostic characteristics or the intervention(s) performed, and dose area product (DAP) per kilogram of body weight (µGy × m2/kg) was summarized. Using empiric and consensus methods, three radiation risk categories were created. A total of 11,735 cases were included for analysis. Thirteen (n = 7918) procedure types with median DAP/kg < 100 were categorized in the low radiation exposure category (median DAP/kg 39). The medium exposure category (n = 1807) consisted of 16 procedure types with median DAP/kg values ranging 100 to < 200 (overall median DAP/kg 131). Finally, the high radiation exposure category (n = 1073) consisted of 11 procedure types with median DAP/kg ≥ 200 (overall median DAP/kg of 231). The radiation exposure risk categories created in this multi-center dataset are a critical step towards the development of a robust risk adjustment methodology for radiation exposure in catheterization for congenital heart disease.