Clinical and hemodynamic outcomes up to 7 years after transcatheter pulmonary valve replacement in the US melody valve investigational device exemption trial

Circulation

Volumn 131, Issue 22, 2015, Pages 1960-1970

  Cheatham, John P ^a   Hellenbrand, William E ^b   Zahn, Evan M ^c   Jones, Thomas K ^d   Berman, Darren P ^a,e   Vincent, Julie A ^f   McElhinney, Doff B ^g  

^a THE OHIO STATE UNIVERSITY COLLEGE OF MEDICINE   (United States)

^b YALE UNIVERSITY   (United States)

^c CEDARS SINAI MEDICAL CENTER   (United States)

^d UNIVERSITY OF WASHINGTON SCHOOL OF MEDICINE   (United States)

^e MIAMI CHILDREN'S HOSPITAL   (United States)

^f Department of Medicine   (United States)

^g STANFORD UNIVERSITY SCHOOL OF MEDICINE   (United States)

Author keywords

Heart diseases; Heart valves; Pediatrics; Pulmonary heart disease; Tetralogy of Fallot

Indexed keywords

ADOLESCENT; ADULT; ARTICLE; BLOODSTREAM INFECTION; CHILD; CLINICAL PROTOCOL; DISEASE ASSOCIATION; DISEASE SEVERITY; ENDOCARDITIS; EXERCISE; FOLLOW UP; HEART RIGHT VENTRICLE OUTFLOW TRACT; HEART RIGHT VENTRICLE OUTFLOW TRACT OBSTRUCTION; HEMODYNAMICS; HOSPITAL DISCHARGE; HUMAN; MAJOR CLINICAL STUDY; NEW YORK HEART ASSOCIATION CLASS; PRIORITY JOURNAL; PROSPECTIVE STUDY; PULMONARY VALVE INSUFFICIENCY; PULMONARY VALVE PROSTHESIS; PULMONARY VALVE REPLACEMENT; SPIROMETRY; STANDARDIZATION; STENOSIS; STENT FRACTURE; SURVIVAL; TREATMENT OUTCOME; CLINICAL TRIAL; DEVICES; FEMALE; HEART CATHETERIZATION; HEART VALVE REPLACEMENT; MALE; MIDDLE AGED; PHYSIOLOGY; TRENDS; UNITED STATES; VENTRICULAR OUTFLOW OBSTRUCTION; YOUNG ADULT;

ADOLESCENT; ADULT; CARDIAC CATHETERIZATION; CHILD; FEMALE; FOLLOW-UP STUDIES; HEART VALVE PROSTHESIS IMPLANTATION; HEMODYNAMICS; HUMANS; MALE; MIDDLE AGED; PROSPECTIVE STUDIES; PULMONARY VALVE INSUFFICIENCY; TREATMENT OUTCOME; UNITED STATES; VENTRICULAR OUTFLOW OBSTRUCTION; YOUNG ADULT;

EID: 84935500979     PISSN: 00097322     EISSN: 15244539     Source Type: Journal    
DOI: 10.1161/CIRCULATIONAHA.114.013588     Document Type: Article

References (30)

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;356:1403-1405. doi: 10.1016/S0140-6736(00)02844-0.
2. Zahn EM, Hellenbrand WE, Lock JE, McElhinney DB. Implantation of the Melody transcatheter pulmonary valve in patients with dysfunctional right ventricular outflow tract conduits: early results from the U.S. clinical trial. J Am Coll Cardiol. 2009;54:1722-1729. doi: 10.1016/j.jacc.2009.06.034.
3. 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 U.S. Melody valve trial. Circulation. 2010;122:507-516. doi: 10.1161/CIRCULATIONAHA.109.921692.
4. McElhinney DB, Cheatham JP, Jones TK, Lock JE, Vincent JA, Zahn EM, Hellenbrand WE. 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. doi: 10.1161/CIRCINTERVENTIONS.111.965616.
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. doi: 10.1161/CIRCULATIONAHA.107.735779.
6. Butera G, Milanesi O, Spadoni I, Piazza L, Donti A, Ricci C, Agnoletti G, Pangrazi A, Chessa M, Carminati M. Melody transcatheter pulmonary valve implantation: results from the registry of the Italian Society of Pediatric Cardiology (SICP). Catheter Cardiovasc Interv. 2013;81:310-316. doi: 10.1002/ccd.24518.
7. Eicken A, Ewert P, Hager A, Peters B, Fratz S, Kuehne T, Busch R, Hess J, Berger F. Percutaneous pulmonary valve implantation: two-centre experience with more than 100 patients. Eur Heart J. 2011;32:1260-1265. doi: 10.1093/eurheartj/ehq520.
8. Gillespie MJ, Rome JJ, Levi DS, Williams RJ, Rhodes JF, Cheatham JP, Hellenbrand WE, Jones TK, Vincent JA, Zahn EM, McElhinney DB. Melody® valve implant within failed bioprosthetic valves in the pulmonary position: a multicenter experience. Circ Cardiovasc Interv. 2012;5:862-870. doi: 10.1161/CIRCINTERVENTIONS.112.972216.
9. Armstrong AK, Balzer DT, Cabalka AK, Gray RG, Javois AJ, Moore JW, Rome JJ, Turner DR, Zellers TM, Kreutzer J. One-year follow-up of the Melody transcatheter pulmonary valve multicenter post-approval study. JACC Cardiovasc Interv. 2014;7:1254-1262. doi: 10.1016/j.jcin.2014.08.002.
10. Coats L, Khambadkone S, Derrick G, Sridharan S, Schievano S, Mist B, Jones R, Deanfield JE, Pellerin D, Bonhoeffer P, Taylor AM. Physiological and clinical consequences of relief of right ventricular outflow tract obstruction late after repair of congenital heart defects. Circulation. 2006;113:2037-2044. doi: 10.1161/CIRCULATIONAHA.105.591438.
11. Coats L, Khambadkone S, Derrick G, Hughes M, Jones R, Mist B, Pellerin D, Marek J, Deanfield JE, Bonhoeffer P, Taylor AM. Physiological consequences of percutaneous pulmonary valve implantation: the different behaviour of volume- and pressure-overloaded ventricles. Eur Heart J. 2007;28:1886-1893. doi: 10.1093/eurheartj/ehm181.
12. Romeih S, Kroft LJ, Bokenkamp R, Schalij MJ, Grotenhuis H, Hazekamp MG, Groenink M, de Roos A, Blom NA. Delayed improvement of right ventricular diastolic function and regression of right ventricular mass after percutaneous pulmonary valve implantation in patients with congenital heart disease. Am Heart J. 2009;158:40-46. doi: 10.1016/j.ahj.2009.04.023.
13. Lurz P, Puranik R, Nordmeyer J, Muthurangu V, Hansen MS, Schievano S, Marek J, Bonhoeffer P, Taylor AM. Improvement in left ventricular filling properties after relief of right ventricle to pulmonary artery conduit obstruction: contribution of septal motion and interventricular mechanical delay. Eur Heart J. 2009;30:2266-2274. doi: 10.1093/eurheartj/ehp258.
14. Batra AS, McElhinney DB, Wang W, Zakheim R, Garofano RP, Daniels C, Yung D, Cooper DM, Rhodes J. Cardiopulmonary exercise function among patients undergoing transcatheter pulmonary valve implantation in the US Melody valve investigational trial. Am Heart J. 2012;163:280-287. doi: 10.1016/j.ahj.2011.10.017.
15. Brown DW, McElhinney DB, Araoz PA, Zahn EM, Vincent JA, Cheatham JP, Jones TK, Hellenbrand WE, O'Leary PW. Reliability and accuracy of echocardiographic right heart evaluation in the U.S. Melody Valve Investigational Trial. J Am Soc Echocardiogr. 2012;25:383-392.e4. doi: 10.1016/j.echo.2011.12.022.
16. Lurz P, Nordmeyer J, Giardini A, Khambadkone S, Muthurangu V, Schievano S, Thambo JB, Walker F, Cullen S, Derrick G, Taylor AM, Bonhoeffer P. Early versus late functional outcome after successful percutaneous pulmonary valve implantation: are the acute effects of altered right ventricular loading all we can expect? J Am Coll Cardiol. 2011;57:724-731. doi: 10.1016/j.jacc.2010.07.056.
17. Müller J, Engelhardt A, Fratz S, Eicken A, Ewert P, Hager A. Improved exercise performance and quality of life after percutaneous pulmonary valve implantation. Int J Cardiol. 2014;173:388-392. doi: 10.1016/j.ijcard.2014.03.002.
18. Harrild DM, Marcus E, Hasan B, Alexander ME, Powell AJ, Geva T, McElhinney DB. Impact of transcatheter pulmonary valve replacement on biventricular strain and synchrony assessed by cardiac magnetic resonance feature tracking. Circ Cardiovasc Interv. 2013;6:680-687. doi: 10.1161/CIRCINTERVENTIONS.113.000690.
19. Nordmeyer J, Khambadkone S, Coats L, Schievano S, Lurz P, Parenzan G, Taylor AM, Lock JE, Bonhoeffer P. Risk stratification, systematic classification, and anticipatory management strategies for stent fracture after percutaneous pulmonary valve implantation. Circulation. 2007;115:1392-1397. doi: 10.1161/CIRCULATIONAHA.106.674259.
20. Morray BH, McElhinney DB, Cheatham JP, Zahn EM, Berman DP, Sullivan PM, Lock JE, Jones TK. Risk of coronary artery compression among patients referred for transcatheter pulmonary valve implantation: a multicenter experience. Circ Cardiovasc Interv. 2013;6:535-542. doi: 10.1161/CIRCINTERVENTIONS.113.000202.
21. 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. doi: 10.1161/CIRCINTERVENTIONS.112.000087.
22. Nordmeyer J, Coats L, Lurz P, Lee TY, Derrick G, Rees P, Cullen S, Taylor AM, Khambadkone S, Bonhoeffer P. Percutaneous pulmonary valve-in-valve implantation: a successful treatment concept for early device failure. Eur Heart J. 2008;29:810-815. doi: 10.1093/eurheartj/ehn073.
23. Sterrett LE, Ebenroth ES, Query C, Ho J, Montgomery GS, Hurwitz RA, Baye F, Schamberger MS. Why exercise capacity does not improve after pulmonary valve replacement. Pediatr Cardiol. 2014;35:1395-1402. doi: 10.1007/s00246-014-0942-2.
24. Hasan BS, Lunze FI, Chen MH, Brown DW, Boudreau MJ, Rhodes J, McElhinney DB. Effects of transcatheter pulmonary valve replacement on the hemodynamic and ventricular response to exercise in patients with obstructed right ventricle-to-pulmonary artery conduits. JACC Cardiovasc Interv. 2014;7:530-542. doi: 10.1016/j.jcin.2014.02.006.
25. 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. doi: 10.1161/CIRCINTERVENTIONS.113.000881.
26. Meadows JJ, Moore PM, Berman DP, Cheatham JP, Cheatham SL, Porras D, Gillespie MJ, Rome JJ, Zahn EM, McElhinney DB. Use and performance of the Melody Transcatheter Pulmonary Valve in native and postsurgical, nonconduit right ventricular out-flow tracts. Circ Cardiovasc Interv. 2014;7:374-380. doi: 10.1161/CIRCINTERVENTIONS.114.001225.
27. Patel M, Iserin L, Bonnet D, Boudjemline Y. Atypical malignant late infective endocarditis of Melody valve. J Thorac Cardiovasc Surg. 2012;143:e32-e35. doi: 10.1016/j.jtcvs.2012.01.006.
28. Buber J, Bergersen L, Lock JE, Gauvreau K, Esch JJ, Landzberg MJ, Valente AM, Sandora TJ, Marshall AC. Bloodstream infections occurring in patients with percutaneously implanted bioprosthetic pulmonary valve: a single-center experience. Circ Cardiovasc Interv. 2013;6:301-310. doi: 10.1161/CIRCINTERVENTIONS.112.000348.
29. Villafañe J, Baker GH, Austin EH 3rd, Miller S, Peng L, Beekman R 3rd. Melody(®) pulmonary valve bacterial endocarditis: experience in four pediatric patients and a review of the literature. Catheter Cardiovasc Interv. 2014;84:212-218.
30. Nordmeyer J, Lurz P, Khambadkone S, Schievano S, Jones A, McElhinney DB, Taylor AM, Bonhoeffer P. Pre-stenting with a bare metal stent before percutaneous pulmonary valve implantation: acute and 1-year outcomes. Heart. 2011;97:118-123. doi: 10.1136/hrt.2010.198382.