Off-label use of percutaneous pulmonary valved stents in the right ventricular outflow tract: Time to rewrite the label?

Catheterization and Cardiovascular Interventions

Volumn 81, Issue 6, 2013, Pages 987-995

  Boshoff, Derize E ^a   Cools, Bjorn L M ^a   Heying, Ruth ^a   Troost, Els ^a   Kefer, Joelle ^a   Budts, Werner ^a   Gewillig, Marc ^a  

^a UNIVERSITY HOSPITALS LEUVEN   (Belgium)

Author keywords

percutaneous pulmonary valve; pulmonary stenosis regurgitation; right ventricular outflow tract; stenting

Indexed keywords

ADOLESCENT; ARTICLE; BALLOON DILATATION; CHILD; CLINICAL ARTICLE; CLINICAL EFFECTIVENESS; CONTROLLED STUDY; FALLOT TETRALOGY; HEART CATHETERIZATION; HEART RIGHT VENTRICLE OUTFLOW TRACT OBSTRUCTION; HEART VENTRICLE SEPTUM DEFECT; HUMAN; OFF LABEL DEVICE USE; PERCUTANEOUS PULMONARY VALVE IMPLANTATION; PULMONARY VALVE REPLACEMENT; PULMONARY VALVE STENOSIS; RETROSPECTIVE STUDY; SAFETY; SCHOOL CHILD; STENT; TREATMENT RESPONSE;

ADOLESCENT; ADULT; AGED; AGED, 80 AND OVER; BLOOD VESSEL PROSTHESIS; BLOOD VESSEL PROSTHESIS IMPLANTATION; CARDIAC CATHETERIZATION; CHILD; FEASIBILITY STUDIES; HEART VALVE PROSTHESIS; HEART VALVE PROSTHESIS IMPLANTATION; HUMANS; MIDDLE AGED; PATIENT SELECTION; PRODUCT LABELING; PROSTHESIS DESIGN; PULMONARY VALVE INSUFFICIENCY; PULMONARY VALVE STENOSIS; RETROSPECTIVE STUDIES; STENTS; TIME FACTORS; TREATMENT OUTCOME; YOUNG ADULT;

EID: 84876468925     PISSN: 15221946     EISSN: 1522726X     Source Type: Journal    
DOI: 10.1002/ccd.24594     Document Type: Article

References (25)

1. Bonhoeffer P, Boudjemline Y, Saliba Z, Merckx J, Aggoun Y, Bonnet D, Acar P, Le Bidois J, Sidi D, Kachaner J,. Percutaneous replacement of pulmonary valve in a right ventricle to pulmonary artery prosthetic conduit with valve dysfunction. Lancet 2000; 21: 1403-1405.
2. Khambadkone S, Nordmeyer J, Bonhoeffer P,. Percutaneous implantation of the pulmonary and aortic valves: Indications and limitations. J Cardiovasc Med 2007; 8: 57-61.
3. Kenny D, Hijazi ZM, Kar S, Rhodes J, Mullen M, Makker R, Shirali G, Fogel M, Fahey J, Heitschmidt MG, Cain C,. Percutaneous implantation of the Edwards SAPIEN transcatheter heart valve for conduit failure in the pulmonary position. J Am Coll Cardiol 2011; 58: 2248-2256.
4. Price MJ, Teirstein PS,. The off-versus on-label use of medical devices in interventional cardiovascular medicine: Clarifying the ambiguity between regulatory labeling and clinical decision-making, Part 1: PCI. Catheter Cardiovasc Interv 2008; 72: 500-504.
5. Lurz P, Coats L, Khambadkone S, Nordmeyer J, Boudjemline Y, Schievano S, Muthurangu V, Lee TY, Parenzan G, Derrick G, Cullen S, Walker F, Tsang V, Deanfield J, Taylor AM, Bonhoeffer P,. Percutaneous pulmonary valve implantation: Impact of evolving technology and learning curve on clinical outcome. Circulation 2008; 117: 1964-1972.
6. Bonhoeffer P, Boudjemline Y, Qureshi SA, Le Bidois J, Iserin L, Acar P, Merckx J, Kachaner J, Sidi D,. Percutaneous insertion of the pulmonary valve. J Am Coll Cardiol 2002; 39: 1664-1669.
7. Khambadkone S, Coats L, Taylor A, Boudjemline Y, Derrick G, Tsang V, Cooper J, Muthurangu V, Hegde SR, Razavi RS, Pellerin D, Deanfield J, Bonhoeffer P,. Percutaneous pulmonary valve implantation in humans: Results in 59 consecutive patients. Circulation 2005; 112: 1189-1197.
8. Sridharan S, Coats L, Khambadkone S, Taylor AM, Bonhoeffer P,. Images in cardiovascular medicine. Transcatheter right ventricular outflow tract intervention: The risk to the coronary circulation. Circulation 2006; 113: e934-e935.
9. Schievano S, Coats L, Migliavacca F, Norman W, Frigiola A, Deanfield J, Bonhoeffer P, Taylor AM,. Variantions in right ventricular outflowtract morphology following repair of congenital heart disease: Implications for percutaneous valve implantation. J Cardiovasc Magn Reson 2007; 9: 687-695.
10. Momenah TS, El Oakley R, Al Najashi K, Khoshhal S, Al Qethamy H, Bonhoeffer P,. Extended application of percutaneous pulmonary valve implantation. J Am Coll Cardiol 2009; 19; 53: 1859-1863.
11. Gewillig M, Mertens L, Stockx L,. Percutaneous fenestration of the atrial septum with a stent: An experimental study. Cor Europaneum 1995; 4: 122-125.
12. Boudjemline Y, Agnoletti G, Bonnet D, Sidi D, Bonhoeffer P,. Percutaneous pulmonary valve replacement in a large right ventricular outflow tract: An experimental study. J Am Coll Cardiol 2004; 43: 1082-1087.
13. Robb JD, Harris MA, Minakawa M, Rodriguez, Koomalsingh KJ, Shuto T, Shin DC, Dori Y, Glatz AC, Rome JJ, Gorman RC, Gorman JH III, Gillespie MJ,. Melody valve implantation into the branch pulmonary arteries for treatment of pulmonary insufficiency in an ovine model of right ventricular outflow tract dysfunction following tetralogy of fallot repair. Circ Cardiovasc Interv 2011; 4: 80-87.
14. Kostolny M, Tsang V, Nordmeyer J, Van Doorn C, Frigiola A, Khambadkone S, de Leval MR, Bonhoeffer P,. Rescue surgery following percutaneous pulmonary valve implantation. Eur J Cardiothorac Surg 2008; 33: 607-612.
15. McElhinney DB, Hellenbrand WE, Zahn EM, Jones TK, Cheatham JP, Lock JE, Vincent JA,. Short- and medium-term outcomes after transcatheter pulmonary valve placement in the expanded multicenter US melody valve trial. Circulation 2010; 122: 507-516.
16. Sutherell JS, Hirch R, Beekman RH,. Paediatric interventional cardiology in the United States is dependent on the off-label use of medical devices. Congenit Heart Dis 2010; 5: 2-7.
17. Smith JJ, Berlin L,. Malpractive issues in radiology: Off-label use of interventional medical devices. Am J Radiol 1999; 173: 539-542.
18. Smith JJ,. Regulatory and legal implications of modifying FDA-approved medical devices. J Vasc Interv Rad 2000; 11: 19-23.
19. Beekman RH, Duncan BW, Hagler DJ, Joned TK, Kugler JD, Moore JW, Jenkins KJ,. Pathways to approval of pediatric cardiac devices in the United States: Challenges and solutions. Pediatrics 2009; 124: 155-162.
20. Hill P,. Off license and off label prescribing in children: Litigation fears for physicians. Arch Dis Child 2005; 90: i17-18.
21. Zvavanjanja RC, Odetoyinbo TO, Rowlands PC, Healey A, Abdelsalam H, Powell S, Evans JC, Hughes ML, Gould DA, McWilliams RG,. Off label use of devices and drugs in interventional radiology. Clin Radiol 2012; 67: 239-243.
22. FDA. Device labeling guidance (G91-1). Available at: http://www.fda.gov/ cdrh/g91-1.html; 1991, Accessed February 2, 2012.
23. Gewillig M, Dubois C,. Percutaneous re-revalvulation of the tricuspid valve. Catheter Cardiovasc Interv 2011; 77: 692-695.
24. Roberts PA, Boudjemline Y, Cheatham JP, Eicken A, Ewert P, McElhinney DB, Hill SL, Berger F, Khan D, Schranz D, Hess J, Ezekowitz MD, Celermajer D, Zahn E,. Percutaneous tricuspid valve replacement in congenital and acquired heart disease. J Am Coll Cardiol 2011; 58: 117-122.
25. Kondo N, Shuto T, McGarvey JR, Koomalsingh KJ, Takebe M, Gorman RC, Gorman JH III, Gillespie MJ,. Melody valve-in-ring procedure for mitral valve replacement: Feasibility in four annuloplasty types. Ann Thorac Surg 2012; 93: 783-788.