Congenital Heart Interventions

Safety and Short-Term Outcomes for Infants < 2.5 kg Undergoing PDA Device Closure: A C3PO Registry Study. Barry OM, Gudausky TM, Balzer DT, Bocks ML, Boe BA, Callahan R, El-Said H, Farias MJ, Foerster S, Goldstein BH, Holzer RJ, Janssen D, Levy P, O'Byrne ML, Rahman G, Sathanandam S, Shahanavaz S, Whiteside W, Turner ME.Pediatr Cardiol. 2023 Aug;44(6):1406-1413. doi: 10.1007/s00246-023-03147-4. Epub 2023 Mar 30.PMID: 36995404 Commentary from Dr. Milan Prsa (Switzerland, Europe), section editor of Congenital Heart Disease Interventions Journal Watch: Take home points: Transcatheter PDA closure can be effectively and safely performed in infants <2.5 kg, even in low-volume centers. Adverse events are associated with the presence of non-cardiac problems and the use of multiple devices during the procedure. Despite ongoing controversy as to the indications and timing of the procedure, transcatheter closure of a hemodynamically significant patent ductus arteriosus (PDA) in premature infants is being increasingly performed across centers. The authors present findings from the largest multi-center retrospective review of PDA device closure in infants weighing less than 2.5 kg using data from the Congenital Cardiac Catheterization Project on Outcomes (C3PO) registry. Data were collected from April 2019 to December 2020 across 13 participating centers. A total of 300 cases were analyzed with an emphasis on procedural success, defined as effective device placement at the conclusion of the catheterization, and the occurrence of adverse events (AEs). Characteristics associated with outcomes were additionally explored. The results show a remarkable procedural success rate of 98.7% (on the first attempt in 92% of cases), predominantly with the Amplatzer Piccolo Occluder, used in 78% of cases. The incidence of moderate severity (level 3) AEs was 5.6%, including 4 device embolizations, and there were five cases (1.7%) with major/catastrophic (level 4/5) AEs, including one patient who died 12 h after the procedure due to post ligation syndrome and urosepsis (Table 1). There was no significant association between procedural success or AEs and factors such as patient age, weight, or institutional volume. However, a higher risk of AEs was associated with patients who had non-cardiac problems and procedures where multiple devices were attempted. This study showcases the high success rate of PDA device closure in very small infants across various institutions, paving the way for more widespread adoption of this procedure. It highlights the importance of careful patient and device selection to minimize the risk of serious adverse events in this vulnerable population. Long-term follow-up is necessary to fully understand the implications of early PDA device closure. Table 1. Adverse events by severity level Adverse eventsn (% of total cases)Level 3 (moderate) adverse events17 (5.6) Device embolization4 (1.3) Depressed cardiac output2 (0.7) Systemic arterial thrombosis2 (0.7) Atrial arrhythmia1 (0.3) Hypotension1 (0.3) Hypoxia1 (0.3) Medication error1 (0.3) Post-extubation stridor1 (0.3) Respiratory distress1 (0.3) Sinus tachycardia1 (0.3) Tricuspid regurgitation1 (0.3) Vessel trauma1 (0.3)Level 4/5 (major/catastrophic) adverse events5 (1.7) Device malposition2 (0.7) Respiratory arrest2 (0.7) Death1 (0.3) *Two cases had two level 3/4/5 events each

3-year follow-up of a prospective, multicenter study of the Amplatzer Piccolo™ Occluder for transcatheter patent ductus arteriosus closure in children ≥ 700 grams. Morray BH, Sathanandam SK, Forbes T, Gillespie M, Berman D, Armstrong AK, Shahanavaz S, Jones T, Rockefeller T, Justino H, Nykanen D, Weiler C, Gutfinger D, Zahn EM.J Perinatol. 2023 Oct;43(10):1238-1244. doi: 10.1038/s41372-023-01741-1. Epub 2023 Aug 16.PMID: 37587183  Take Home Points Overall survival at 3-year follow-up for the entire cohort was 95.3% and for patients ≤2 Kg at the time of implant was 92.9%. 9 patients died following device placement but causes of death were reviewed independently by the clinical events committee and no deaths were adjudicated as device or procedure related. Beyond 6 months there were no additional device or procedure replated complications. An increase in tricuspid regurgitation (TR) was reported in 5 patients but none required intervention to repair or replace the tricuspid valve at 3-year follow-up. Echocardiography follow-up demonstrated effective patent ductus arteriosus (PDA) closure achieved in 97.4% of patients at 30 days post implant, 99.4% at 6 months and 100% through 3-years. Commentary from Dr. Jonathon Hagel (C.S. Mott Children’s Hospital, University of Michigan)             Transcatheter patent ductus arteriosus (PDA) closure is the mainstay of therapy in older children and adults though controversy has persisted about the optimal approach to PDA closure in preterm infants. The Amplatzer Piccolo Occluder (Abbott Structural Heart, Plymouth, MN) was approved for commercial use in the United States by the Food and Drug Administration in 2019 for PDA closure in patients ≥700. Patients began enrollment in June 2017 for the prospective single arm multicenter pre-marked study to characterize the safety and effectiveness of the Amplatzer Piccolo Occluder in children ≥700g and ≥3 days of age at the time of implant. The procedural outcomes and 6-month clinical data were previously published. This study reports the 3-year clinical outcomes in this cohort of patients.             A total of 200 patients were enrolled in the study and the entire cohort was split evenly by weight ≤2 Kg (n=100) and ≥2 Kg (n=100). The mean weight of infants referred from the NICU was 0.85 +/- 0.29 Kg and had a mean gestational age of 26 +/- 3 weeks. There were 9 unsuccessful implants, 5 patient deaths prior to 6-month follow up and an additional 4 patient deaths after six months leaving 182 patients available for analysis at 3-year follow up.             Overall patient survival at 3 years was 95.3% and for children ≤2 Kg was 92.9%. Beyond 6-months there were no additional device or procedure related adverse events. All patient deaths were independently reviewed by the clinical events committee and found to be unrelated to the procedure or device. Only 33 echocardiograms were available at 3-year follow-up but all (33/33) demonstrated complete PDA closure with no residual defect. There was no late cases of aortic obstruction and no cases of LPA obstruction requiring intervention at 3-year follow up. An increase in TR was reported in 5 patients with four available for analysis at 3-year follow up and none required intervention or repair of the tricuspid valve.              The authors conclude that transcatheter PDA closure with the Amplatzer Piccolo Occluder is safe and effective and with 3-year follow up there is 100% successful closure and >95% survival.  They concede, however, that although a high rate of technical success and low rates of complications are achieved, the impact on the clinical course of patients treated with this device requires ongoing investigation.  

Safety and utility of CardioMEMS device for remote pulmonary artery monitoring in pediatric Fontan patients: a case series. Bhat DP, Graziano JN, Garn BJ, Franklin WJ.Eur Heart J Case Rep. 2023 Aug 30;7(9):ytad422. doi: 10.1093/ehjcr/ytad422. eCollection 2023 Sep. PMID: 37705945 Commentary from Dr. Thomas Zellers (Dallas, USA), section editor of Congenital Heart Disease Interventions and ACHD Journal Watch: Take home points: Fontan pressures may change with activity, elevation, and cardiac function CardioMEMS is a tool that can be used for pulmonary artery pressure monitoring at home CardioMEMS can be easily and safely implanted in Fontan patients using transcatheter methods Summary: This a single center, retrospective case report of the use of the CardioMEMS device, between 09/2021 and 04/2023, in eight selective patients post Fontan procedure with Fontan associated liver disease (FALD) or protein losing enteropathy (PLE) and whose pulmonary artery pressures were in question and underwent cardiac catheterization under anesthesia. All had device placement at the time of cardia catheterization to monitor changes in PA pressures. All these patients had PA pressures that measured lower than expected given their associated organ dysfunction. The authors present all 8 patients highlighting 2 patients who had significant increases (up to 18-20 mmHg) in their PA pressures noted by the CardioMEMS device which allowed the primary cardiologists to alter their medical therapy. The authors felt that their two cases specifically illustrate that pulmonary artery pressures can be underestimated in these patients with FALD and PLE who have catheterization under anesthesia. They emphasize that the CardioMEMS can be implanted safely and provides important follow-up hemodynamic information in this subset of Fontan patient, and potentially improves the medical management in selective situations. Tables: Table 1

Outcomes and Risk Factors of Interventions for Pediatric Post-operative Pulmonary Vein Stenosis. Fujita KT, DiLorenzo MP, Krishnan US, Turner ME, Barry OM, Torres AJ, Bacha EA, Kalfa D, Crystal MA. Pediatr Cardiol. 2023 Dec;44(8):1778-1787. doi: 10.1007/s00246-023-03214-w. Epub 2023 Jul 9. PMID: 37422845 Take Home Points: Outcomes for pediatric patients with pulmonary vein stenosis remain guarded with a possible survival advantage if an aggressive treatment strategy is undertaken. In patients with recurrent post-operative PVS mortality is associated with complex congenital heart disease, single ventricle heart disease and genetic disorders. Commentary from Dr. Konstantin Averin (Cohen Children’s Heart Center), catheterization section editor of Pediatric Cardiology Journal Watch: Pulmonary vein stenosis (PVS) in pediatric patients with congenital heart disease is a complex disease that carries a high degree of morbidity and mortality.  Surgery for PVS is often preferred as the baseline intervention for PVS as it may be associated with greater freedom from reintervention and death compared to a baseline trans-catheter approach.  Outcomes for treatment of recurrent PVS after baseline surgical repair have not been assessed.  The authors sought to evaluate outcomes and identify risk factors associated with patient mortality and vein atresia in post-operative PVS patients in a single center. From January 2005 to July 2020, 305 patients underwent baseline surgical repair with 46 (15%) requiring reintervention for PVS and comprising the primary study cohort (Figure 1). The median age at baseline surgery of the study cohort was 18.9 days (0-42.8 months) and the time from baseline surgery to the first (index) procedure for recurrence was 4.4 months (0.7-79.5 mon).   The total number of procedures varied, but 3 patients required 6 and transcatheter approaches were more commonly chosen for patients who require more interventions.  Overall, 11 (23.9%) patients died at a median 1.6 months (1 day-9.7 years) after the index procedure (first procedure for recurrent PVS) with presence of a genetic disorder, single ventricle physiology and complex congenital heart disease being associated with mortality.  Half of the cohort developed pulmonary vein atresia of at least one vein and interestingly all patients who had necrotizing enterocolitis developed atresia. This small, descriptive study continues to add to the literature surrounding treatment and outcomes of pediatric patients with PVS.  Many providers hypothesize that aggressive treatment of recurrent PVS with frequent, repeat interventions may confer a survival advantage and while this study found that repeat interventions were associated with improved survival this may represent survival bias as death occurred relatively soon after the index procedure.  Some interesting associations were also reported (i.e. necrotizing enterocolitis and male gender with pulmonary vein atresia) but this will need to be explored in future studies with larger patient volumes.  Figure 1. Figure 2.