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.

Modified delivery of SAPIEN 3 valve in the pulmonary position: Evolution of technique or dire need?

Transcatheter pulmonary valve replacement (TPVR) is now common practice in patients with significant pulmonary regurgitation (PR), stenosis (PS), or mixed pulmonary valve disease. While the Melody valve (Medtronic, Inc.) and its delivery system were specifically designed for use in the right ventricular outflow tract (RVOT), Sapien valves (XT and S3, Edwards Lifesciences, Inc.) and their delivery systems (Novaflex and Commander) were not. As a result, placement of Sapien valves in the RVOT can be challenging secondary to the stiffness of the current delivery system. Manipulating a stiff delivery system within the RV also introduces risk to the tricuspid valve and its chordal attachments. We report a novel delivery technique for the Sapien S3 valve which has greatly simplified valve delivery into the RVOT and may potentially reduce the risk of tricuspid valve injury.

Surgical Versus Percutaneous Closure of PDA in Preterm Infants: Procedural Charges and Outcomes.

BACKGROUND: Studies comparing percutaneous closure of patent ductus arteriosus (PDA) with surgical ligation tend to exclude premature infants and have not assessed procedural charges. We compared our contemporary outcomes and charges of device closure to surgical ligation of PDA in preterm infants. MATERIAL AND METHODS: Preterm infants who underwent isolated PDA closure during their newborn hospitalization (January 2014 to September 2017) were grouped based on intention to treat (surgery versus device closure). Patient demographics, procedural details, and immediate postprocedural outcomes were compared. Procedural charges for device closure versus surgical ligation were compared. RESULTS: Compared with the device group (n = 33), patients undergoing surgical ligation (n = 39) were younger, smaller, and required more preoperative support (P < 0.05). The procedure time was shorter for surgical ligation (P < 0.01). Although there was no procedural mortality in either group, the complication rate was higher for device closure than for surgical ligation (15.2% versus 0%; P = 0.02). The proportion of patients returning to preprocedural respiratory support by 48 h after procedure was similar. There was a higher proportion of surgical patients who required increased inotropic support in the first 24 h after procedure (P = 0.19). The procedural charges for transcatheter device closure were twice as expensive as those for surgical ligation. CONCLUSIONS: In our early experience with percutaneous PDA closure, we found a percutaneous approach in preterm infants feasible and well tolerated. Both surgical ligation and device closure were associated with perioperative or postoperative complications. Procedural charges were higher for percutaneous closure, driven by device charge and catheterization room utilization. Further investigation is needed to establish guidelines for first-line therapy for PDA closure in preterm infants, including cost-benefit analysis.

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.

Fracturing a dysfunctional Edwards Perimount bioprosthetic valve to facilitate percutaneous valve-in-valve placement of SAPIEN 3 valve with modified delivery system.

Pulmonary valve replacement via surgical implantation of a bioprosthetic valve (BPV) is a well-established treatment for patients with dysfunctional RV outflow tracts. BPVs are prone to structural deterioration, and will eventually require replacement. Recently, percutaneous valve-in-valve (VIV) placement of transcatheter valves has established itself as a safe and effective alternative to surgical revision. Unfortunately, VIV therapy is inherently limited by the inner diameter of the BPV, which restricts the number of eligible patients. Other centers have reported on the feasibility of cracking certain BPVs with ultra high-pressure balloons in bench testing. We now report cracking an Edwards Perimount BPV in the pulmonary position to facilitate VIV placement of an Edwards SAPIEN 3. The ability to crack the Perimount valve allowed placement of a larger valve than previously considered and minimized the final valve gradient. In an effort to avoid the morbidity and mortality of surgical pulmonary valve replacement, this new strategy will expand the number of patients eligible for percutaneous VIV therapy.

Post-operative Catheterization Interventions at the Site of Surgery: An Application of the CRISP Scoring System.

Catheter-based interventions in the early post-operative period are performed with caution due to concerns for increased procedural risk, particularly across fresh suture lines. The recently published CRISP scoring system provides prospective risk stratification based on pre-procedural criterion. In an effort to refine the assessment of risk in patients undergoing post-operative catheter-based interventions, the predicted risk of an adverse event based on CRISP scores was compared to actual adverse event rates. A single-center, retrospective review of patients undergoing catheterization interventions within 6 weeks of cardiac surgery was conducted between Jan 2004 and Dec 2014. Patients who underwent dilation interventions across fresh suture lines (group 1) were compared to patients who underwent interventional procedures at other sites (group 2), and a CRISP score was calculated for all patients. Patients receiving only surveillance biopsies were excluded. Sixty-eight patients underwent 100 interventional procedures. Group 1 was composed of 44 patients receiving 64 interventions, while group 2 had 24 patients who underwent 36 interventions. Group 1 was comprised significantly more single ventricles and patients were smaller/younger. Group 1 had a significantly higher median CRISP score, but both groups were within Category 4. The rates of adverse events were similar between groups and comparable to predicted rates with the CRISP scoring system. Catheter-based interventions in the early post-operative period can be performed with no significant increase in the risk of serious adverse events when intervening across fresh suture lines. The CRISP scoring system can be a valuable tool in pre-procedural counseling of high-risk post-operative patients.

Abnormalities of the Coronary Arteries in Children: Looking beyond the Origins.

Coronary arterial abnormalities are uncommon findings in children that have profound clinical implications. Although anomalies of the coronary origins are well described, there are many other disease processes that affect the coronary arteries. Immune system-mediated diseases (eg, Kawasaki disease, polyarteritis nodosa, and other vasculiditides) can result in coronary arterial aneurysms, strictures, and abnormal tapering of the vessels. Because findings at imaging are an important component of diagnosis in these diseases, the radiologist's understanding of them is essential. Congenital anomalies may present at varying ages, and findings in hemodynamically significant anomalies, such as fistulas, are key for both diagnosis and preoperative planning. Pediatric heart surgery can result in wide-ranging postoperative imaging appearances of the coronary arteries and also predisposes patients to a multitude of complications affecting the heart and coronary arteries. In addition, although rare, accidental trauma can lead to injury of the coronary arteries, and awareness and detection of these conditions are important for diagnosis in the acute setting. Patients with coronary arterial conditions at presentation may range from being asymptomatic to having findings of myocardial infarction. Recognition of the imaging findings is essential to direct appropriate treatment. ©RSNA, 2017.

Transcatheter implantation of SAPIEN 3 valve in native right ventricular outflow tract for severe pulmonary regurgitation following tetralogy of fallot repair.

Pulmonary valve replacement (PVR) is indicated in patients with significant pulmonary regurgitation (PR), stenosis (PS), or mixed pulmonary valve disease. While once an exclusively surgical procedure, many patients can undergo transcatheter PVR (TPVR) with excellent early outcomes (Haas et al. 2013, Clin. Res. Cardiol. Off. J. German Cardiac Soc. 102:119-128; Kenny et al. 2011, J. Am. Coll. Cardiol. 58:2248-2256; Cheatham et al. Circulation 2015, 131:1960-1970). The available transcatheter options continue to expand, but the majority of cases performed in the United States involve the use of FDA approved Melody valve (Medtronic; Minneapolis, MN) or the SAPIEN (Edwards Lifesciences; Irvine, CA) family of valves. The SAPIEN 3 valve (S3) recently received FDA approval for transcatheter aortic valve replacement. We report the first S3 implantation in the pulmonary position for treatment of chronic pulmonary regurgitation and progressive right ventricular dilation in an 18 year old male with repaired Tetralogy of Fallot. © 2016 Wiley Periodicals, Inc.

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.

3D Printing Provides a Precise Approach in the Treatment of Tetralogy of Fallot, Pulmonary Atresia with Major Aortopulmonary Collateral Arteries.

Patients with tetralogy of Fallot, pulmonary atresia, and multiple aortopulmonary collateral arteries (Tet PA MAPCAs) have a wide spectrum of anatomy and disease severity. Management of these patients can be challenging and often require multiple high-risk surgical and interventional catheterization procedures. These interventions are made challenging by complex anatomy that require the proceduralist to mentally reconstruct three-dimensional anatomic relationships from two-dimensional images. Three-dimensional (3D) printing is an emerging medical technology that provides added benefits in the management of patients with Tet PA MAPCAs. When used in combination with current diagnostic modalities and procedures, 3D printing provides a precise approach to the management of these challenging, high-risk patients. Specifically, 3D printing enables detailed surgical and interventional planning prior to the procedure, which may improve procedural outcomes, decrease complications, and reduce procedure-related radiation dose and contrast load.