Usefulness of PREDIC3T Case Type Risk Category in the CRISP Registry.

Procedural risk in Congenital Cardiac Catheterization (PREDIC3T) was recently reported as the contemporary procedure-type risk metric by the Congenital Cardiac Catheterization Project on Outcomes (C3PO) registry. The usefulness of this metric has not been evaluated elsewhere. The CRISP registry of Congenital Cardiovascular Interventional Study Consortium (CCISC) data set was analyzed. The study period was 14 years (2009 to 2022). The primary outcome was significant adverse event (SAE). Cases were assigned to the 6 PREDIC3T risk categories. Univariate and multivariable logistic regression models were used to evaluate the association between PREDIC3T and the primary outcome. The model discriminative performance was evaluated by the c-statistic. In a total of 64,419 enrolled cases, PREDIC3T case types were assigned in 59,822 cases (93%). The frequency for PREDIC3T category was 0 = 7,494 (12.5%), 1 = 16,932 (28.3%), 2 = 17,023 (28.5%), 3 = 9,885 (16.5%), 4 = 4,403 (7.4%), and 5 = 4,085 (6.8%). SAE was observed in 2,474 cases (4.1%). The SAE rates for category were 0 = 1.0%, 1 = 2.3%, 2 = 4.0%, 3 = 6.2%, 4 = 8.2%, and 5 = 9.0%. In a multivariable model, PREDIC3T case type risk category (odds ratios for category: 0 = 0.49, 1 = 1.00, 2 = 1.40, 3 = 2.06, 4 = 2.79, and 5 = 3.15; p <0.001) were significantly associated with SAE (c-statistic of 0.707) after adjusting for age, preprocedural inotropic support and systemic illness, low systemic saturation, high pulmonary vascular resistance, and the use of general anesthesia. The PREDIC3T case type risk category was associated with the risk of SAE in the CRISP registry data set and appeared to be a useful procedural risk classification tool.

Incidence, Predictors, and Outcomes of Cardiac Perforation During Pediatric Cardiac Catheterization: a Retrospective Observational Study from the Congenital Cardiac Interventional Study Consortium (CCISC).

INTRODUCTION: Cardiac perforation is a rare life-threatening complication of cardiac catheterization. There is very little published literature detailing risk factors for cardiac perforation and outcomes from this complication in children. MATERIALS AND METHODS: This was a retrospective study analyzing the cardiac catheterization case registry of the Congenital Cardiovascular Interventional Study Consortium. Children aged < 18 years were included during the study period of 9 years (January 2009-December 2017). The primary outcome measures were incidence of cardiac perforation, risk factors for and outcomes of patients who experience cardiac perforation during cardiac catheterization. RESULTS: Cardiac perforation occurred in 50 patients from a total of 36,986 (0.14%). Cardiac perforation was more likely to occur in younger, smaller patients undergoing urgent/emergent and interventional procedures (p < 0.01). Cardiac peroration risk was significantly different across diagnostic and procedure categories (p < 0.01). Higher CRISP score (Area Under Curve [AUC] = 0.87), lower age, and procedure category (radiofrequency perforation of pulmonary valve, AUC = 0.84) were independent predictors of cardiac perforation. Cardiac perforation was associated with a significantly higher rate of mortality (14%), further emergency procedure (42%), ECMO (14%), and cardiac arrest (6%), p < 0.01. CONCLUSIONS: Cardiac perforation during cardiac catheterization is a life-threatening complication with a range of associated secondary complications. Higher CRISP score, lower age, and radiofrequency perforation of pulmonary valve are independent predictors.

Renal Function After Transcatheter Piccolo Patent Ductus Arteriosus Closure With Contrast Angiography in Extremely Premature Infants.

Transcatheter patent ductus arteriosus (PDA) device closure is increasingly performed in extremely premature infants. Contrast angiography improves the procedural safety and effectiveness by precise anatomic delineation. Contrast nephropathy is a concern in clinically ill premature infants, especially with the presence of renal insufficiency. We hypothesized that the benefit of transcatheter PDA closure outweighs the harm of contrast nephropathy in extremely premature infants. A total of 160 infants underwent successful transcatheter (n = 59) and surgical (n = 101) PDA closure at a median age of 26 (7 to 78) days. The surgical group had a lower procedural weight (870 vs 960 g, p = 0.014). In the transcatheter group, serum creatinine decreased from 0.48 to 0.45 mg/100 ml at 24 hours (p = 0.003, n = 59) and decreased further to 0.37 mg/100 ml at 5 to 7 days after closure (p <0.001). Median contrast amount was 1.9 ml/kg (0.6 to 6.1). In 8 infants with pre-existing renal insufficiency who underwent transcatheter closure, serum creatine significantly improved from 1.44 to 1.36 mg/100 ml at 24 hours and 0.79 mg/100 ml at 5 to 7 days after closure (p <0.001). There was no difference in improvement of serum creatinine between transcatheter and surgical closure groups. In conclusion, despite the use of contrast, serum creatinine significantly improved with transcatheter PDA closure even in infants with pre-existing renal insufficiency. Contrast angiography should not be discouraged for transcatheter PDA closure because of the concern for contrast nephropathy in extremely premature infants.

Pericardiocentesis in children: 20-year experience at a tertiary children's hospital.

BACKGROUND: Pericardiocentesis is the invasive percutaneous procedure for acute and chronic excessive accumulation of pericardial fluid. There is a paucity of data on the effectiveness and safety of pericardiocentesis in children. OBJECTIVES: To evaluate the effectiveness and safety of pericardiocentesis and factors associated with acute procedural failure and adverse events. METHODS: This was a single-centered retrospective study to describe all the children aged ≤20 years who underwent pericardiocentesis. Data on demographics, etiologies of pericardial effusion, and repeat intervention at follow-up were collected. RESULTS: A total of 127 patients underwent 153 pericardiocentesis. The median age was 6.5 years (1 day-20 years) with weight of 17 kg (0.5-125). Most common etiology was post-pericardiotomy syndrome (n = 56, 44%), followed by infectious (12%), malignant (10%), and iatrogenic (9%). Pericardiocentesis was performed more commonly in the catheterisation laboratory (n = 86, 59%). Concurrent pericardial drain placement was performed in 67 patients (53%). Acute procedural success was 92% (141/153). Repeat intervention was performed in 33 patients (22%). The incidence of adverse events was 4.6% (7/153): hemopericardium requiring emergent surgery (n = 2); hemopericardium with hypotension (n = 2); seizure with anesthesia induction (n = 1); and right ventricle puncture with needle (n = 2). Pericardiocentesis at the bedside had a higher rate of acute procedural failure than that in the catheterisation lab (17 versus 1%, p < 0.01). No identifiable risk factors were associated with adverse events. CONCLUSIONS: Pericardiocentesis was life-saving in children with its high effectiveness and safety even in urgent situations. Although initial pericardiocentesis was effective, one of five patients required re-intervention for recurrent pericardial effusion.

Covered Stent Placement for Subclavian Vein Stenosis Associated With Basilic Arteriovenous Fistula.

Arteriovenous fistula (AVF) creation is used to palliate complex cyanotic heart diseases. We report an adult patient with AVF creation who subsequently developed severe left subclavian vein stenosis, causing significant left arm swelling. Covered stent placement successfully treated the venous stenosis, resulting in the normalization of his left arm swelling.

Transjugular venous approach for Piccolo patent ductus arteriosus closure in a 1.4 kg infant.

Transfemoral venous approach is the standard method for transcatheter patent ductus arteriosus closure using the Amplatzer Piccolo patent ductus arteriosus occluder in small infants. We report a 1.4 kg infant who underwent transcatheter Piccolo patent ductus arteriosus closure. Transjugular venous approach was taken due to the unexpected finding of interrupted inferior vena cava.

Left Transjugular Venous Approach for Transcatheter Pulmonary Valve Implantation using Sapien Valve.

Transfemoral and right transjugular approach has been described for transcatheter pulmonary valve implantation (TPVI). However, the use of left transjugular approach through the left superior vena cava to coronary sinus has not been well described. We present a 22-year-old male with Tetralogy of Fallot status post transannular patch, who underwent successful TPVI using the Sapien valve, preceded by pre-stenting of native right ventricular outflow tract. All the transcatheter intervention was performed through the left superior vena cava to coronary sinus.

Impact of Patient Prosthesis Mismatch on the Outcome of Transcatheter Pulmonic Valve Implantation.

Patient prosthesis mismatch (PPM) is an important factor of the outcome in transcatheter aortic valve implantation. However, the impact of PPM in transcatheter pulmonic valve implantation (TPVI) has not been studied. Based on the narrowest valve stent diameters in two views of fluoroscopy, internal geometric orifice area (GOA) of the valve stent was calculated and indexed by body surface area (BSA), deriving iGOA. To define PPM in TPVI, receiver operating characteristics (ROC) curve analysis for iGOA for predicting significant residual right ventricular outflow tract (RVOT) gradient was used to derive the optimal cut-off value of iGOA. Our cohort were divided into 2 groups: PPM versus non-PPM. The clinical data were compared between 2 groups. TPVI was performed using Melody valve in 101 patients. Significant RVOT residual pressure gradient (≥ 15 mmHg) was observed in 31 patients (39.6%). Over a mean follow up periods of 6.9 ± 2.7 years, 22 patients (21.8%) required repeat interventions (16 transcatheter, 11 surgical, and both in 5 patients). Based on the ROC analysis, the best cut-off value of iGOA was 1.25 cm2/m2 (area under the curve 0.873, p < 0.001) to define PPM. PPM was present in 42 patients (42%). On the Kaplan-Meier survival analysis, PPM was associated with the need of repeat intervention (p = 0.02). In conclusion, in TPVI, PPM was a strong predictor for the need of re-intervention. Considering PPM, target diameter of valve stent would depend on the patient body size and should be taken into account for optimal outcome of TPVI.

Membranous septal aneurysm causing severe right ventricular outflow obstruction in an adult with trisomy 18.

Membranous ventricular septal aneurysm is a known entity but rarely causes severe right ventricular outflow obstruction. We report a 40-year-old female with trisomy 18 who developed severe right ventricular outflow obstruction caused by an enormous membranous septal aneurysm associated with unrepaired inlet ventricular septal defect with perimembranous extension.

Optimal criteria for transcatheter closure of Fontan fenestration: a single-center experience with a review of literature.

Fenestration closure is considered to remove the persistent right-to-left shunt after the Fontan operation. However, the criteria for effective transcatheter closure of fenestration to avoid both acute and chronic Fontan failure have not been clarified. The objective of this study was to describe the hemodynamic data with test occlusion of the Fontan fenestration for patients who underwent a closure and those who did not, along with subsequent development of Fontan-associated diseases (FAD) at follow-up. This was a retrospective study conducted to assess the outcome of Fontan fenestration closure at Children's Hospital of Michigan over 27 years (1993-2019). The inclusion criteria were patients undergoing cardiac catheterization indicated for Fontan fenestration closure. Data were compared between the two groups: closure and non-closure patients. Baseline characteristics and hemodynamic variables with the fenestration occlusion test were analyzed. The primary outcome was the development of composite events of death/transplant, deteriorated New York Heart Association class symptoms, or FAD. Among the 38 patients who were brought to the catheterization laboratory, 33 received fenestration closure and 5 did not. On a median follow-up of 3.4 years (range, 1 month-12.6 years), the incidence of primary adverse outcomes was 13% (5/38). The incidence of primary outcome was significantly higher in the non-closure group (60% vs. 6%, p < 0.01). The non-closure group had a higher incidence of moderate or severe atrioventricular valve regurgitation, New York Heart Association class III symptoms, use of angiotensin-converting enzyme inhibitor/angiotensin receptor blocker, furosemide use, and sildenafil use. The multivariable logistic regression model showed that the hemodynamic variables associated with the non-closure group were mean left atrial pressure (odds ratio 1.74, p < 0.05) and change of mean Fontan pressure at the balloon occlusion (odds ratio 2.2, p < 0.05). The judgment of fenestration closure appeared appropriate in our cohort. Fontan fenestration closure may not be advisable in cases with a high baseline left atrial pressure or a significant increase in Fontan pressure on balloon occlusion testing.

Femoral Artery Thrombosis After Pediatric Cardiac Catheterization.

Femoral artery thrombosis (FAT) is an adverse event post-catheterization. We decided to study the incidence and risk factors of FAT before and after initiation of a pulse loss monitoring program. All cardiac catheterization cases performed using femoral arterial vascular access were retrospectively reviewed. The study period was divided into two eras: before (era 1), and after the initiation of the protocol (era 2). The primary outcome was FAT requiring therapy. Univariable and multivariable logistic regression models were used to identify factors associated with FAT. Receiver operating characteristic curve were generated to predict FAT. Our cohort consisted of 2,388 cases including 467 (19.6%) infants weighing < 10 kg. The overall incidence of FAT was 1.7% (n = 41). The incidence of FAT was 3.5 times higher in era 2 (p < 0.001). Multivariable model showed that era, weight, sheath exchange, and coarctation intervention were significantly associated with FAT. Infants younger than 7.7 months and less than 6.7 kg were found to be at highest risk for FAT. Our study shows that the incidence of FAT may be underestimated without a monitoring program. Small infants and coarctation interventions requiring larger sheaths or sheath exchanges are at highest risk for FAT.

Cardiac catheterization for hemoptysis in a Children's Hospital Cardiac Catheterization Laboratory: A 15 year experience.

OBJECTIVES: The aim of this study was to evaluate the diagnostic utility of cardiac catheterization and the efficacy of transcatheter intervention in patients with hemoptysis. BACKGROUND: Cardiac catheterization may play a role in identifying the etiologies of hemoptysis with the potential for transcatheter intervention. METHODS: This was a retrospective study of all the patients who were brought to the pediatric cardiac catheterization laboratory for the indication of hemoptysis over a 15-year period (2006-2020). RESULTS: Twenty-one patients underwent 28 cardiac catheterizations. The median age was 17.4 years (range 0.3-60.0 years), and the underlying cardiac diagnoses were normal heart n = 3, pulmonary hypertension 1, heart transplant 1, pulmonary arteriovenous malformation 1, pulmonary vein disease 3, biventricular congenital heart diseases 5, and single ventricles 7. The diagnostic utility of catheterization was 81% (17/21). At two-thirds (18/28) of catheterizations, transcatheter interventions were performed in 14/21 (67%) patients: aortopulmonary collateral embolization 14, aortopulmonary and veno-venous collateral embolization 1, and pulmonary arteriovenous malformation embolization 3. Although recurrent hemoptysis was frequent (50%) post-intervention, the final effectiveness of transcatheter interventions was 79% (11/14 patients). Overall mortality was 19% (4/21), all in those presenting with massive hemoptysis. CONCLUSIONS: Cardiac catheterization was shown to have good diagnostic utility for hemoptysis especially in patients with underlying congenital heart disease. Despite the high mortality and recurrent hemoptysis rate, transcatheter interventions were effective in our cohort.

Single center experience of pediatric percutaneous balloon pericardiotomy.

BACKGROUND: Percutaneous balloon pericardiotomy is a percutaneous procedure that creates a window in the parietal pericardium by balloon dilation. The use of percutaneous balloon pericardiotomy has not been reported well in children. OBJECTIVES: The objective of this study was to describe the single centre experience of percutaneous balloon pericardiotomy in children. METHODS: This was a retrospective study to describe all the children aged <20 years undergoing percutaneous balloon pericardiotomy during an 18-year period (2001-2019). Patient characteristics, technical and ultimate procedural success, and repeat interventions were collected. RESULTS: A total of 13 percutaneous balloon pericardiotomy's were performed in 11 children at the median age of 12 years (range 1.8-19). The etiologies of pericardial effusion were post-pericardiotomy syndrome (n = 4), restrictive cardiomyopathy (n = 1), autoimmune diseases (n = 3), malignancy (n = 2), and idiopathic (n = 1). Two patients received two percutaneous balloon pericardiotomy. The technical success of percutaneous balloon pericardiotomy was 100% with no acute adverse events (balloon rupture or local bleeding). Five (45%) required re-intervention and ultimately three required a surgical pericardial window 6 to 35 days after the percutaneous balloon pericardiotomy. As a result, ultimate procedural success rate was 73% (8/11). CONCLUSION: Percutaneous balloon pericardiotomy was performed safely with high technical success in children. Percutaneous balloon pericardiotomy may be considered for recurrent and persistent pericardial effusion, before considering a surgical pericardial window.

Hot topics in interventional cardiology: Proceedings from the society for cardiovascular angiography and interventions 2020 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 for high-level field-wide discussions. The 2020 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 (CHD). 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 dialogue from a broader base, and thereby aid SCAI and the industry community in developing specific action items to move these areas forward.

Saccular "Cauliflower" aneurysm of coarctation of aorta: a hybrid management.

Aneurysm formation around the site of coarctation of aortic arch is a well-recognised complication of untreated coarctation and is associated with an increased risk of aortic rupture and mortality. We present a rare case in a teenage girl with the combination of significant aortic arch coarctation, a "cauliflower-like" saccular aneurysm, and stenosis at the origin of the left subclavian artery. She was successfully managed with a hybrid approach, which is a combination of an endovascular surgical repair (a bypass graft placement from left carotid artery to subclavian artery by a vascular surgeon) and a transcatheter covered stent placement across the stenosis and aneurysm. This case highlights the successful role of a hybrid approach in patient's who present with a combination of coarctation of the aorta and aortic arch aneurysms. This approach avoids the conventional surgical aortoplasty, which carries a higher mortality and morbidity risk in teenage patients.

Recurrent infective endocarditis in a patient after a second Melody valve placement.

A 16-year-old Caucasian male was diagnosed with recurrent infective endocarditis associated with his second Melody valve placed inside a previously treated infected Melody valve. The replacement of Melody valve after the first infective endocarditis episode might increase the risk of the second episode of infective endocarditis.

Amplatzer Piccolo Occluder clinical trial for percutaneous closure of the patent ductus arteriosus in patients ≥700 grams.

OBJECTIVES: Characterize the safety and effectiveness of the Amplatzer Piccolo Occluder for patent ductus arteriosus (PDA) closure. BACKGROUND: The presence of a hemodynamically significant PDA has been associated with an increased risk of morbidity and mortality in children born premature. METHODS: This was a single arm, prospective, multicenter, non-randomized study to evaluate the Amplatzer Piccolo Occluder to treat PDA in patients ≥700 g. From June 2017 to February 2019, 200 patients were enrolled at nine centers, with 100 patients weighing ≤2 kg. Primary effectiveness endpoint was the rate of PDA closure at 6-month follow-up. Primary safety endpoint was the rate of major complications through 6 months. Secondary endpoint was rate of significant pulmonary or aortic obstruction through 6 months' follow-up. RESULTS: The implant success rate was 95.5% (191/200) overall and 99% in patients ≤2 kg (99/100). The primary effectiveness endpoint was achieved in 99.4% of implanted patients. Four patients experienced a primary safety endpoint event (2 transfusions, 1 hemolysis, and 1 aortic obstruction). There were no branch pulmonary artery obstructions. Five patients, all ≤2 kg, were noted to have worsening of tricuspid regurgitation (TR) after the procedure. None of the TR incidences manifested clinically. The Amplatzer Piccolo Occluder received FDA approval in January 2019 and became the first device approved for PDA closure in patients ≥700 g. CONCLUSIONS: This study supports the safety and effectiveness of the Amplatzer Piccolo Occluder, particularly in patients between 700 g and 2 kg where there is currently a significant unmet need in the United States. ClinicalTrials.gov identifier: NCT03055858.

Partnership Between Japan and the United States for Early Development of Pediatric Medical Devices　- Harmonization By Doing for Children.

BACKGROUND: The Harmonization By Doing (HBD) program was established in 2003 as a partnership among stakeholders of academia, industry and regulatory agencies in Japan and the United States, with a primary focus on streamlining processes of global medical device development for cardiovascular medical devices. While HBD has traditionally focused on development of devices intended to treat conditions prevalent in adults, in 2016, HBD established the "HBD-for-Children" program, which focuses on the development of pediatric devices as the development of medical devices for pediatric use lags behind that of medical devices for adults in both countries.Methods and Results:Activities of the program have included: (1) conducting a survey with industry to better understand the challenges that constrain the development of pediatric medical devices; (2) categorizing pediatric medical devices into five categories based on global availability and exploring concrete solutions for the early application and regulatory approval in both geographies; and (3) facilitating global clinical trials of pediatric medical devices in both countries. CONCLUSIONS: The establishment of the HBD-for-Children program is significant because it represents a global initiative for the introduction of pediatric medical devices for patients in a timely manner. Through the program, academia, industry and regulatory agencies can work together to facilitate innovative pediatric device development from a multi-stakeholder perspective. This activity could also encourage industry partners to pursue the development of pediatric medical devices.