Procedural Results and Safety of Common Interventional Procedures in Congenital Heart Disease

Moore, John W.; Vincent, Robert; Beekman, Robert H.; Benson, Lee; Bergersen, Lisa; Holzer, Ralf; Jayaram, Natalie; Jenkins, Kathy J.; Li, Yan; Ringel, Richard; Rome, Jonathan J.; Martin, Gerard R.

doi:10.1016/j.jacc.2014.09.045

Cited by 122 publications

(81 citation statements)

References 23 publications

Supporting

Mentioning

Contrasting

Unclassified

Order By: Relevance

“…Major and total adverse event rates were 1.6% and 7.2%, both significantly smaller than after surgical repair. The subsequent IMPACT Registry and MAGIC study reported similar success and complication rates [42,43]. ASO embolization is the most frequent adverse event as reported by the FDA Manufacturer and User Facility Device Experience database, accounting for 51% of events with a rate of 0.2-1.1%.…”

Section: Amplatzer Septal Occluder (Aso)mentioning

confidence: 85%

Historical developments of atrial septal defect closure devices: what we learn from the past

Nassif

Abdelghani

Bouma

et al. 2016

Expert Review of Medical Devices

View full text Add to dashboard Cite

Introduction: Since King and Mills' pioneering work in percutaneous closure devices of secundum atrial septal defects (ASD) four decades ago, developments in device shape, material and implantation technique led to adoption of percutaneous ASD closure as current treatment of choice. Not only was the feasibility of such a percutaneous procedure tested altogether, but pursuing the ideal device in terms of safety and efficacy became priority. Areas covered: In this review we present the historical development of ASD devices in design, material and technique with clinical data, and provide the future perspectives in percutaneous ASD closures. Expert opinion: An 'ideal device' requires complete defect closure with negligible risk of complications using a safe, straightforward delivery technique with repositioning and retrieving properties. Some of the devices currently at hand come close to fulfilling these criteria, however none seem to provide those prerequisites completely. By understanding how challenges in device development were overcome in the past, new insights into future improvements are given. ARTICLE HISTORY

show abstract

Section: Amplatzer Septal Occluder (Aso)mentioning

confidence: 85%

Historical developments of atrial septal defect closure devices: what we learn from the past

Nassif

Abdelghani

Bouma

et al. 2016

Expert Review of Medical Devices

View full text Add to dashboard Cite

show abstract

“…Though quantifying its incidence has proved challenging, the current most conservative estimates of the risk of erosion appears to be 1 in 1000 9, 28 , from which an unknown fraction develop life-threatening tamponade. The risk of procedure-associated death in isolated TC-ASD in published series are 0–0.15%(30,34,35). The best estimates of risk-adjusted procedural mortality following O-ASD, as derived from the Society for Thoracic Surgeons Congenital Heart Surgeons Database, are between 3–9 per 1,000(5,36,37).…”

Section: Discussionmentioning

confidence: 99%

“…Though natural history studies demonstrate that patients with large ASD left untreated have dramatically reduced lifespan(42,43), to our knowledge, there is no evidence that early intervention produces dramatically different results in terms of any clinical outcome. There are multiple series that demonstrate that ASD can be closed in young patients(30,34,35,41), and conventional wisdom holds that closure of ASD surgically does not depend on patient size in a meaningful way. It is unclear what the impetus is for the trend towards progressively earlier intervention.…”

Section: Discussionmentioning

confidence: 99%

Increasing propensity to pursue operative closure of atrial septal defects following changes in the instructions for use of the Amplatzer Septal Occluder device: An observational study using data from the Pediatric Health Information Systems database

O’Byrne

Shinohara

Grant

et al. 2017

American Heart Journal

View full text Add to dashboard Cite

Objectives Study trends in the treatment of atrial septal defects (ASD). Background Concern for device erosion following transcatheter treatment of ASD (TC-ASD) led in 2012 to a US FDA panel review and changes in the instructions for use (IFU) of the Amplatzer Septal Occluder (ASO) device. No studies have assessed the effect of these changes on real-world practice. Methods A retrospective observational study was performed using data from the Pediatric Health Information Systems Database of all patients with isolated ASD undergoing either TC-ASD or operative ASD closure (O-ASD) from 1/1/2007 to 9/30/2015, hypothesizing that the propensity to pursue O-ASD increased beginning in 2013. Results 6,392 cases from 39 centers underwent ASD closure (82% TC-ASD). Adjusting for patient factors, between 2007 and 2012, the probability of pursuing O-ASD decreased (OR: 0.95 per year, p=0.03). This trend reversed beginning in 2013, with the probability of O-ASD increasing annually (OR: 1.21, p=0.006). There was significant between-hospital variation in the choice between TC-ASD and O-ASD (median odds ratio: 2.79, p<0.0001). The age of patients undergoing ASD closure (regardless of method) decreased over the study period (p=0.04). Cost of O-ASD increased over the study period, while cost of TC-ASD and LOS for both O-ASD and TC-ASD was unchanged. Conclusion Though TC-ASD remains the predominant method of ASD closure, the propensity to pursue O-ASD has increased significantly following changes in IFU for ASO. Further research is necessary to determine what effect this has on outcomes and resource utilization.

show abstract

“…Die häufigsten Maßnahmen im Herzkatheterlabor betreffen Verschlüsse von Atriumseptumdefekten (ASD), Eingriffe am persistierenden Ductus arteriosus (PDA), im Aortenisthmus, an den Pulmonalarterien (PA) sowie an der Aorten-und Pulmonalklappe [21]. Der vorliegende Beitrag bietet hinsichtlich der häufigsten Eingriffe eine Übersicht über die aktuelle Situation, den State of the Art, die Grenzen sowie die Entwicklung und wesentlichsten Trends in der interventionellen Kinderkardiologie.…”

Section: Hintergrundunclassified

Interventionelle Kinderkardiologie – Entwicklungen, Trends und Grenzen

Prandstetter

2018

Monatsschr Kinderheilkd

View full text Add to dashboard Cite

Procedural Results and Safety of Common Interventional Procedures in Congenital Heart Disease

Abstract: Contemporary community practice, procedural outcomes, and safety for 6 common congenital interventional procedures are reported. These benchmarks may be compared with individual center results and historical single-center and multicenter results.

Cited by 122 publications

References 23 publications

Historical developments of atrial septal defect closure devices: what we learn from the past

Historical developments of atrial septal defect closure devices: what we learn from the past

Increasing propensity to pursue operative closure of atrial septal defects following changes in the instructions for use of the Amplatzer Septal Occluder device: An observational study using data from the Pediatric Health Information Systems database

Interventionelle Kinderkardiologie – Entwicklungen, Trends und Grenzen

Contact Info

Product

Resources

About