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Post-market surveillance to detect adverse events associated with Melody® valve implantation

Published online by Cambridge University Press:  10 November 2016

Kevin D. Hill ,
Bryan H. Goldstein ,
Michael J. Angtuaco ,
Patricia Y. Chu  and
Gregory A. Fleming
Kevin D. Hill*
Affiliation:
Department of Pediatrics, Duke University Medical Center, Durham, North Carolina, United States of America
Bryan H. Goldstein
Affiliation:
The Heart Institute, Cincinnati Children’s Hospital Medical Center, Cincinnati, Ohio, United States of America
Michael J. Angtuaco
Affiliation:
Department of Pediatrics, University of Arkansas for Medical Sciences, Little Rock, Arkansas, United States of America
Patricia Y. Chu
Affiliation:
Department of Pediatrics, Duke University Medical Center, Durham, North Carolina, United States of America
Gregory A. Fleming
Affiliation:
Department of Pediatrics, Duke University Medical Center, Durham, North Carolina, United States of America
*
Correspondence to: K. D. Hill, MD, MS, Duke Clinical Research Institute, 2400 Pratt Street, Durham, NC 27705, United States of America. Tel: 919 668 8305; Fax: 1919 287 2612; E-mail: [email protected]
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Abstract

Objective

The aim of this study was to describe previously unrecognised or under-recognised adverse events associated with Melody® valve implantation.

Background

In rare diseases and conditions, it is typically not feasible to conduct large-scale safety trials before drug or device approval. Therefore, post-market surveillance mechanisms are necessary to detect rare but potentially serious adverse events.

Methods

We reviewed the United States Food and Drug Administration’s Manufacturer and User Facility Device Experience (MAUDE) database and conducted a structured literature review to evaluate adverse events associated with on- and off-label Melody® valve implantation. Adverse events were compared with those described in the prospective Investigational Device Exemption and Post-Market Approval Melody® transcatheter pulmonary valve trials.

Results

We identified 631 adverse events associated with “on-label” Melody® valve implants and 84 adverse events associated with “off-label” implants. The most frequent “on-label” adverse events were similar to those described in the prospective trials including stent fracture (n=210) and endocarditis (n=104). Previously unrecognised or under-recognised adverse events included stent fragment embolisation (n=5), device erosion (n=4), immediate post-implant severe valvar insufficiency (n=2), and late coronary compression (n=2 cases at 5 days and 3 months after implantation). Under-recognised adverse events associated with off-label implantation included early valve failure due to insufficiency when implanted in the tricuspid position (n=7) and embolisation with percutaneous implantation in the mitral position (n=5).

Conclusion

Post-market passive surveillance does not demonstrate a high frequency of previously unrecognised serious adverse events with “on-label” Melody® valve implantation. Further study is needed to evaluate safety of “off-label” uses.

Keywords

MAUDE databasedevice safetytranscatheter pulmonary valve
Type
Original Articles
Information
Cardiology in the Young , Volume 27 , Issue 6 , August 2017 , pp. 1090 - 1097
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Copyright
© Cambridge University Press 2016 

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References

1. United States Food and Drug Administration. Humanitarian device exemption approval letter. Retrieved October 4, 2015, from http://www.accessdata.fda.gov/cdrh_docs/pdf8/H080002a.pdf.Google Scholar
2. Lurz, P, Coats L, Khambadkone S, et al. Percutaneous pulmonary valve implantation: impact of evolving technology and learning curve on clinical outcome. Circulation 2008; 117: 1964–1972.Google Scholar
3. Lurz, P, Gaudin R, Taylor AM, Bonhoeffer P. Percutaneous pulmonary valve implantation. Semin Thorac Cardiovasc Surg Pediatr Card Surg Annu 2009: 112–117.CrossRefGoogle ScholarPubMed
4. McElhinney, DB, Hellenbrand WE, Zahn EM, et al. Short- and medium-term outcomes after transcatheter pulmonary valve placement in the expanded multicenter US melody valve trial. Circulation 2010; 122: 507–516.Google Scholar
5. Zahn, EM, Hellenbrand WE, Lock JE, McElhinney DB. Implantation of the melody transcatheter pulmonary valve in patients with a dysfunctional right ventricular outflow tract conduit early results from the U.S. clinical trial. J Am Coll Cardiol 2009; 54: 1722–1729.Google Scholar
6. Medtronic Press Release from February 3, 2015. Retrieved October 3, 2015, from http://newsroom.medtronic.com/phoenix.zhtml?c=251324&p=irol-newsArticle&ID=2013134.Google Scholar
7. Gurtcheff, SE. Introduction to the MAUDE database. Clin Obstet Gynecol 2008; 51: 120–123.Google Scholar
8. United States Food and Drug Administration Manufacturer and User Facility Device Experience (MAUDE) database. Retrieved August 1, 2015, from http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Search.cfm.Google Scholar
9. Taggart, NW, Connolly, HM, Hagler, DJ. Acute heart failure after percutaneous pulmonary valve (melody(copyright) valve) implantation. Catheter Cardiovasc Interv 2011; 77: S139–S140.Google Scholar
10. Taggart, NW, Hagler, DJ, Connolly, HM. Melody valve erosion into the ascending aorta. Congenit Heart Dis 2013; 8: E64.CrossRefGoogle ScholarPubMed
11. Peer, SM, Sinha, P. Percutaneous pulmonary valve implantation after Ross-Konno aortoventriculoplasty: a cautionary word. J Thorac Cardiovasc Surg 2014; 147: e74–e75.Google Scholar
12. Biermann, D, Schonebeck J, Rebel M, Weil J, Reichenspurner H, Dodge-Khatami A. Coronary event after transcatheter pulmonary valve implantation. Thorac Cardiovasc Surg 2012; 94: e7–e9.Google Scholar
13. Dehghani, P, Kraushaar, G, Taylor, DA. Coronary artery compression three months after transcatheter pulmonary valve implantation. Catheter Cardiovasc Interv 2015; 851: 611–614.Google Scholar
14. Berman, DP, McElhinney DB, Vincent JA, Hellenbrand WE, Zahn EM. Feasibility and short-term outcomes of percutaneous transcatheter pulmonary valve replacement in small (<30 kg) children with dysfunctional right ventricular outflow tract conduits. Circ Cardiovasc Interv 2014; 7: 142–148.CrossRefGoogle ScholarPubMed
15. Armstrong, AK, Balzer DT, Cabalka AK, et al. One-year follow-up of the Melody transcatheter pulmonary valve multicenter post-approval study. JACC Cardiovasc Interv 2014; 7: 1254–1262.CrossRefGoogle ScholarPubMed
16. Bishnoi, RN, Jones TK, Kreutzer J, Ringel RE. NuMED Covered Cheatham-Platinum Stent for the treatment or prevention of right ventricular outflow tract conduit disruption during transcatheter pulmonary valve replacement. Catheter Cardiovasc Interv 2015; 85: 421–427.Google Scholar
17. McElhinney, DB, Benson LN, Eicken A, Kreutzer J, Padera RF, Zahn EM. Infective endocarditis after transcatheter pulmonary valve replacement using the melody valve: combined results of 3 prospective North American and European studies. Circ Cardiovasc Interv 2013; 6: 292–300.Google Scholar
18. McElhinney, DB, Cheatham JP, Jones TK, et al. Stent fracture, valve dysfunction, and right ventricular outflow tract reintervention after transcatheter pulmonary valve implantation: patient-related and procedural risk factors in the US melody valve trial. Circ Cardiovasc Interv 2011; 4: 602–614.Google Scholar
19. Medtronic Melody valve sponsor executive summary to the United States Food and Drug Administration including instructions for use. Retrieved August 11, 2015, from http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/CirculatorySystemDevicesPanel/UCM172725.pdf.Google Scholar
20. Levinson, D. Inspector General, Department of Health and Human Services. Adverse event reporting for medical devices. October 2009. Retrieved March 8, 2016, from http://oig.hhs.gov/oei/reports/oei-01-08-00110.pdf..Google Scholar
21. DiBardino, DJ, McElhinney DB, Kaza AK, Mayer JE, Jr. 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 2009; 137: 1334–1341.Google Scholar
22. Lenzer, J, Brownlee, S. Why the FDA can’t protect the public. BMJ 2010; 341: c4753.Google Scholar
23. Van Dijck, I, Budts W, Cools B, et al. Infective endocarditis of a transcatheter pulmonary valve in comparison with surgical implants. Heart 2015; 101: 788–793.Google Scholar
24. Buber, J, Bergersen L, Lock JE, et al. Bloodstream infections occurring in patients with percutaneously implanted bioprosthetic pulmonary valve: a single-center experience. Circ Cardiovasc Interv 2013; 6: 301–310.Google Scholar
25. Sutherell, JS, Hirsch, R, Beekman, RH 3rd. Pediatric interventional cardiology in the United States is dependent on the off-label use of medical devices. Congenit Heart Dis 2010; 5: 2–7.Google Scholar
26. Torres, A, Sanders SP, Vincent JA, et al. Iatrogenic aortopulmonary communications after transcatheter interventions on the right ventricular outflow tract or pulmonary artery: pathophysiologic, diagnostic, and management considerations. Catheter Cardiovasc Interv 2015; 86: 438–452.Google Scholar
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