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

American Heart Journal

Volumn 192, Issue , 2017, Pages 85-97

  O'Byrne, Michael L ^a   Shinohara, Russell T ^b   Grant, Elena K ^a   Kanter, Joshua P ^a   Gillespie, Matthew J ^c   Dori, Yoav ^c   Rome, Jonathan J ^c   Glatz, Andrew C ^c  

^a GEORGE WASHINGTON UNIVERSITY SCHOOL OF MEDICINE AND HEALTH SCIENCES   (United States)

^b UNIVERSITY OF PENNSYLVANIA   (United States)

^c CHILDREN S HOSPITAL OF PHILADELPHIA   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ADOLESCENT; CHILD; CLINICAL TRIAL; FEMALE; FOOD AND DRUG ADMINISTRATION; HEART CATHETERIZATION; HEART SEPTAL DEFECTS, ATRIAL; HUMAN; MALE; MEDICAL INFORMATION SYSTEM; MULTICENTER STUDY; PRESCHOOL CHILD; PROCEDURES; PROPENSITY SCORE; PROTOCOL COMPLIANCE; RETROSPECTIVE STUDY; SEPTAL OCCLUDER; TRANSESOPHAGEAL ECHOCARDIOGRAPHY; TREATMENT OUTCOME; UNITED STATES;

ADOLESCENT; CARDIAC CATHETERIZATION; CHILD; CHILD, PRESCHOOL; ECHOCARDIOGRAPHY, TRANSESOPHAGEAL; FEMALE; GUIDELINE ADHERENCE; HEALTH INFORMATION SYSTEMS; HEART SEPTAL DEFECTS, ATRIAL; HUMANS; MALE; PROPENSITY SCORE; RETROSPECTIVE STUDIES; SEPTAL OCCLUDER DEVICE; TREATMENT OUTCOME; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 85027527798     PISSN: 00028703     EISSN: 10976744     Source Type: Journal    
DOI: 10.1016/j.ahj.2017.07.012     Document Type: Article

References (45)

1. Hoffman, J.I.E., Kaplan, S., The incidence of congenital heart disease. J Am Coll Cardiol 39:12 (2002), 1890–1900.
2. King, T.D., Thompson, S.L., Steiner, C., et al. Secundum atrial septal defect. Nonoperative closure during cardiac catheterization. JAMA 235:23 (1976), 2506–2509.
3. Du, Z.D., Hijazi, Z.M., Kleinman, C.S., et al. Comparison between transcatheter and surgical closure of secundum atrial septal defect in children and adults: results of a multicenter nonrandomized trial. J Am Coll Cardiol 39:11 (2002), 1836–1844.
4. Rosas, M., Zabal, C., Garcia-Montes, J., et al. Transcatheter versus surgical closure of secundum atrial septal defect in adults: impact of age at intervention. A concurrent matched comparative study. Congenit Heart Dis 2:3 (2007), 148–155 [Blackwell Publishing Inc.].
5. O'Byrne, M.L., Gillespie, M.J., Shinohara, R.T., et al. Cost comparison of transcatheter and operative closures of ostium secundum atrial septal defects. Am Heart J, 169(5), 2015, 727-735.e2.
6. Kutty, S., Abu Hazeem, A., Brown, K., et al. Long-term (5- to 20-year) outcomes after transcatheter or surgical treatment of hemodynamically significant isolated secundum atrial septal defect. Am J Cardiol 109:9 (2012), 1348–1352 [Elsevier Inc.].
7. Butera, G., Biondi-Zoccai, G., Sangiorgi, G., et al. Percutaneous versus surgical closure of secundum atrial septal defects: a systematic review and meta-analysis of currently available clinical evidence. EuroIntervention 7:3 (2011), 377–385.
8. Kotowycz, M.A., Therrien, J., Ionescu-Ittu, R., et al. Long-term outcomes after surgical versus transcatheter closure of atrial septal defects in adults. JACC Cardiovasc Interv 6:5 (2013), 497–503 [Elsevier Inc.].
9. Amin, Z., Hijazi, Z.M., Bass, J.L., et al. Erosion of Amplatzer septal occluder device after closure of secundum atrial septal defects: review of registry of complications and recommendations to minimize future risk. Cathet Cardiovasc Intervent 63:4 (2004), 496–502.
10. Amin, Z., Echocardiographic predictors of cardiac erosion after Amplatzer septal occluder placement. Catheter Cardiovasc Interv 83:1 (2014), 84–92.
11. Delaney, J.W., Li, J.S., Rhodes, J.F., Major complications associated with transcatheter atrial septal occluder implantation: a review of the medical literature and the Manufacturer and User Facility Device Experience (MAUDE) database. Congenit Heart Dis 2 (2007), 1–9.
12. Crawford, G.B., Brindis, R.G., Krucoff, M.W., et al. Percutaneous atrial septal occluder devices and cardiac erosion: a review of the literature. Catheter Cardiovasc Interv 80:2 (2012), 157–167.
13. Diab, K., Kenny, D., Hijazi, Z.M., Erosions, erosions, and erosions! Device closure of atrial septal defects: how safe is safe?. Cathet Cardiovasc Intervent 80:2 (2012), 168–174.
14. Moore, J., Hegde, S., El-Said, H., et al. Transcatheter device closure of atrial septal defects: a safety review. JACC Cardiovasc Interv 6:5 (2013), 433–442.
15. Rare serious erosion events associated with St. Jude Amplatzer Atrial Septal Occluder (ASO) [Internet], 2013, United States Food and Drug Administration [[cited 2013 Nov 25]. Available from: http://www.fda.gov/medicaldevices/safety/alertsandnotices/ucm371145.htm].
16. Amplatzer septal occluder and delivery system: instructions for use. professional.sjm.com, 2012, 1–16.
17. Mahapatra, S., Graves, A.M., Letter to physicians [Internet]. professional.sjm.com. 2013, 1–2 [cited 2013 Nov 25]. Available from: http://professional.sjm.com/resources/product-performance/amplatzer-septal-occluder-performance/ifu-updates.
18. O'Byrne, M.L., Glatz, A.C., Shinohara, R.T., et al. Effect of center catheterization volume on risk of catastrophic adverse event after cardiac catheterization in children. Am Heart J 169:6 (2015 Jun), 823–825.
19. O'Byrne, M.L., Gillespie, M.J., Shinohara, R.T., et al. Cost comparison of transcatheter and operative pulmonary valve replacement (from the Pediatric Health Information Systems Database). Am J Cardiol 117:1 (2016), 121–126.
20. O'Byrne, M.L., Glatz, A.C., Mercer-Rosa, L., et al. Trends in pulmonary valve replacement in children and adults with tetralogy of Fallot. Am J Cardiol 115:1 (2015), 118–124.
21. O'Byrne, M.L., Glatz, A.C., Hanna, B.D., et al. Predictors of catastrophic adverse outcomes in children with pulmonary hypertension undergoing cardiac catheterization: a multi-institutional analysis from the Pediatric Health Information Systems database. J Am Coll Cardiol 66:11 (2015), 1261–1269.
22. Feudtner, C., Hays, R.M., Haynes, G., et al. Deaths attributed to pediatric complex chronic conditions: national trends and implications for supportive care services. Pediatrics 107 (2001), 1–5.
23. Larsen, K., Merlo, J., Appropriate assessment of neighborhood effects on individual health: integrating random and fixed effects in multilevel logistic regression. Am J Epidemiol 161:1 (2005), 81–88.
24. Peterson, P.N., Chan, P.S., Spertus, J.A., et al. Practice-level variation in use of recommended medications among outpatients with heart failure: insights from the NCDR PINNACLE program. Circ Heart Fail 6:6 (2013), 1132–1138.
25. Maddox, T.M., Chan, P.S., Spertus, J.A., et al. Variations in coronary artery disease secondary prevention prescriptions among outpatient cardiology practices: insights from the NCDR (National Cardiovascular Data Registry). J Am Coll Cardiol 63:6 (2014), 539–546.
26. Hira, R.S., Kennedy, K., Jneid, H., et al. Frequency and practice-level variation in inappropriate and nonrecommended prasugrel prescribing: insights from the NCDR PINNACLE registry. J Am Coll Cardiol 63:25 Pt A (2014), 2876–2877.
27. Singh, V., Badheka, A.O., Patel, N.J., et al. Influence of hospital volume on outcomes of percutaneous atrial septal defect and patent foramen ovale closure: a 10-years US perspective. Catheter Cardiovasc Interv, 22, 2014.
28. Karamlou, T., Diggs, B.S., Ungerleider, R.M., et al. The rush to atrial septal defect closure: is the introduction of percutaneous closure driving utilization?. Ann Thoracic Surg 86:5 (2008), 1584–1591.
29. Butera, G., Romagnoli, E., Carminati, M., et al. Treatment of isolated secundum atrial septal defects: impact of age and defect morphology in 1,013 consecutive patients. Am Heart J 156:4 (2008), 706–712.
30. O'Byrne, M.L., Gillespie, M.J., Kennedy, K.F., et al. The influence of deficient retro-aortic rim on technical success and early adverse events following device closure of secundum atrial septal defects: an analysis of the IMPACT Registry(®). Catheter Cardiovasc Interv 89:1 (2017), 102–111.
31. Taggart, N.W., Dearani, J.A., Hagler, D.J., Late erosion of an Amplatzer septal occluder device 6 years after placement. J Thorac Cardiovasc Surg 142:1 (2011), 221–222.
32. DiBardino, D.J., McElhinney, D.B., Kaza, A.K., et al. Analysis of the US Food and Drug Administration Manufacturer and User Facility Device Experience database for adverse events involving Amplatzer septal occluder devices and comparison with the Society of Thoracic Surgery congenital cardiac surgery database. J Thorac Cardiovasc Surg 137:6 (2009), 1334–1341.
33. DiBardino, D.J., Mayer, J.E. Jr., Continued controversy regarding adverse events after Amplatzer septal device closure: mass hysteria or tip of the iceberg?. J Thorac Cardiovasc Surg 142:1 (2011), 222–223.
34. El-Said, H., Hegde, S., Foerster, S., et al. Device therapy for atrial septal defects in a multicenter cohort: acute outcomes and adverse events. Catheter Cardiovasc Interv 85:2 (2015), 227–233.
35. Moore, J.W., Vincent, R.N., Beekman, R.H., et al. Procedural results and safety of common interventional procedures in congenital heart disease: initial report from the national cardiovascular data registry. J Am Coll Cardiol 64:23 (2014), 2439–2451.
36. Ooi, Y.K., Kelleman, M., Ehrlich, A., et al. Transcatheter versus surgical closure of atrial septal defects in children: a value comparison. JACC Cardiovasc Interv 9:1 (2016), 79–86.
37. O'Brien, S.M., Clarke, D.R., Jacobs, J.P., et al. An empirically based tool for analyzing mortality associated with congenital heart surgery. J Thorac Cardiovasc Surg 138:5 (2009), 1139–1153.
38. McElhinney, D.B., Quartermain, M.D., Kenny, D., et al. Relative risk factors for cardiac erosion following transcatheter closure of atrial septal defects: a case-control study. Circulation 133:18 (2016), 1738–1746.
39. O'Byrne, M.L., Glatz, A.C., Sunderji, S., et al. Prevalence of deficient retro-aortic rim and its effects on outcomes in device closure of atrial septal defects. Pediatr Cardiol [Internet] 35:7 (2014), 1181–1190 Available from: http://link.springer.com/10.1007/s00246-014-0914-6.
40. O'Byrne, M.L., Glatz, A.C., Goldberg, D.J., et al. Accuracy of transthoracic echocardiography in assessing retro-aortic rim prior to device closure of atrial septal defects. Congenit Heart Dis, 2014, 1–9.
41. Petit, C.J., Justino, H., Pignatelli, R.H., et al. Percutaneous atrial septal defect closure in infants and toddlers: predictors of success. Pediatr Cardiol 34:2 (2012), 220–225.
42. Craig, R.J., Selzer, A., Natural history and prognosis of atrial septal defect. Circulation 37:5 (1968), 805–815.
43. Campbel, M., Natural history of atrial septal defect. Br Heart J 32 (1970), 820–826.
44. Bacha, E., Kalfa, D., Minimally invasive paediatric cardiac surgery. Nat Rev Cardiol 11:1 (2014), 24–34.
45. Mitchelson, B., O'Donnell, C., Ruygrok, P., et al. Transcatheter closure of secundum atrial septal defects: has fear of device erosion altered outcomes?. Cardiol Young, 2017, 1–9.