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Review

Transcatheter pulmonary valve implantation: will it replace surgical pulmonary valve replacement?

, & ORCID Icon
Pages 197-207 | Received 03 Oct 2017, Accepted 29 Jan 2018, Published online: 12 Feb 2018

References

  • Marelli AJ, Mackie AS, Ionescu-Ittu R, et al. Congenital heart disease in the general population: changing prevalence and age distribution. Circulation. 2007;115:163–172.
  • Warnes CA, Liberthson R, Danielson GK, et al. Task force 1: the changing profile of congenital heart disease in adult life. J Am Coll Cardiol. 2001;37:1170–1175.
  • Yuan S-M, Mishaly D, Shinfeld A, et al. Right ventricular outflow tract reconstruction: valved conduit of choice and clinical outcomes. J Cardiovasc Med (Hagerstown). 2008;9:327–337.
  • Bonhoeffer P, Boudjemline Y, Saliba Z, et al. Percutaneous replacement of pulmonary valve in a right-ventricle to pulmonary-artery prosthetic conduit with valve dysfunction. Lancet. 2000;356:1403–1405.
  • Peng LF, McElhinney DB, Nugent AW, et al. Endovascular stenting of obstructed right ventricle-to-pulmonary artery conduits: a 15-year experience. Circulation. 2006;113:2598–2605.
  • Putman LM, van Gameren M, Meijboom FJ, et al. Seventeen years of adult congenital heart surgery: a single centre experience. Eur J Cardiothorac Surg. 2009;36:96–104; discussion 104.
  • Bonhoeffer P, Boudjemline Y, Qureshi SA, et al. Percutaneous insertion of the pulmonary valve. J Am Coll Cardiol. 2002;39:1664–1669.
  • Khambadkone S, Coats L, Taylor A, et al. Percutaneous pulmonary valve implantation in humans. Circulation. 2005;112:1189-1197.
  • 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.
  • Asoh K, Walsh M, Hickey E, et al. Percutaneous pulmonary valve implantation within bioprosthetic valves. Eur Heart J. 2010;31:1404–1409.
  • Mulder BJM, De Winter RJ, Wilde AAM. Percutaneous pulmonary valve replacement: a new development in the lifetime strategy for patients with congenital heart disease. Neth Heart J. 2007;15:3–4.
  • Melody® TPV Therapy and Ensemble® Transcatheter Valve Delivery | Medtronic US [Internet]. [cited 2017 Sep 13]. Available from: http://www.medtronic.com/melody/melody-system.html.
  • Biernacka EK, Rużyłło W, Demkow M. Percutaneous pulmonary valve implantation - state of the art and Polish experience. Postep W Kardiol Interwencyjnej = Adv Interv Cardiol. 2017;13:3–9.
  • Kenny D, Hijazi ZM, Kar S, et al. Percutaneous implantation of the Edwards SAPIEN transcatheter heart valve for conduit failure in the pulmonary position. J Am Coll Cardiol. 2011;58:2248–2256.
  • Odemis E, Guzeltas A, Saygi M, et al. Percutaneous pulmonary valve implantation using Edwards SAPIEN transcatheter heart valve in different types of conduits: initial results of a single center experience. Congenit Heart Dis. 2013;8:411–417.
  • Garay F, Webb J, Hijazi ZM. Percutaneous replacement of pulmonary valve using the Edwards-Cribier percutaneous heart valve: first report in a human patient. Catheter Cardiovasc Interv. 2006;67:659–662.
  • Webb JG, Chandavimol M, Thompson CR, et al. Percutaneous aortic valve implantation retrograde from the femoral artery. Circulation. 2006;113:842–850.
  • Baumgartner H, Bonhoeffer P, De Groot NMS, et al. ESC Guidelines for the management of grown-up congenital heart disease (new version 2010). Eur Heart J. 2010;31:2915–2957.
  • Oosterhof T, van Straten A, Vliegen HW, et al. Preoperative thresholds for pulmonary valve replacement in patients with corrected tetralogy of Fallot using cardiovascular magnetic resonance. Circulation. 2007;116:545–551.
  • Feltes TF, Bacha E, Beekman RH, et al. Indications for cardiac catheterization and intervention in pediatric cardiac disease: a scientific statement from the American Heart Association. Circulation. 2011;123:2607–2652.
  • Gatzoulis MA, Balaji S, Webber SA, et al. Risk factors for arrhythmia and sudden cardiac death late after repair of tetralogy of Fallot: a multicentre study. Lancet. 2000;356:975–981.
  • Plymen CM, Bolger AP, Lurz P, et al. Electrical remodeling following percutaneous pulmonary valve implantation. Am J Cardiol. 2011;107:309–314.
  • Andersen HR, Knudsen LL, Hasenkam JM. Transluminal implantation of artificial heart valves. Description of a new expandable aortic valve and initial results with implantation by catheter technique in closed chest pigs. Eur Heart J. 1992;13:704–708.
  • Schievano S, Coats L, Migliavacca F, et al. Variations in right ventricular outflow tract morphology following repair of congenital heart disease: implications for percutaneous pulmonary valve implantation. J Cardiovasc Magn Reson. 2007;9:687–695.
  • Khambadkone S. Percutaneous pulmonary valve implantation. Ann Pediatr Cardiol. 2012;5:53–60.
  • McElhinney DB, Hennesen JT. The Melody® valve and Ensemble® delivery system for transcatheter pulmonary valve replacement. Ann N Y Acad Sci. 2013;1291:77–85.
  • Reinthaler M. Trans-Catheter Pulmonary Valve Implantation: Procedure, Limitations and Future Directions.
  • Gillespie MJ, Dori Y, Harris MA, et al. Bilateral branch pulmonary artery melody valve implantation for treatment of complex right ventricular outflow tract dysfunction in a high-risk patient. Circ Cardiovasc Interv. 2011;4:e21–e23.
  • Edwards SAPIEN Pulmonic Transcather Heart Valve [Internet]. [cited 2017 Sep 13]. Available from: http://www.edwards.com/eu/products/transcathetervalves/pages/pulmonic.aspx.
  • Levi DS, Sinha S, Salem MM, et al. Transcatheter native pulmonary valve and tricuspid valve replacement with the sapien XT: initial experience and development of a new delivery platform. Catheter Cardiovasc Interv. 2016;88:434–443.
  • Hascoët S, Acar P, Boudjemline Y. Transcatheter pulmonary valvulation: current indications and available devices. Arch Cardiovasc Dis. 2014;107:625–634.
  • Chung R, Taylor AM. Imaging for preintervention planning. Circ Cardiovasc Imaging. 2014;7:182-189.
  • Boudjemline Y, Sarquella-Brugada G, Kamache I, et al. Impact of right ventricular outflow tract size and substrate on outcomes of percutaneous pulmonary valve implantation. Arch Cardiovasc Dis. 2013;106:19–26.
  • Alsulami G, Patel M, Malekzadeh-Milani S, et al. Hyperacute flash pulmonary oedema after transcatheter pulmonary valve implantation: the melody of an overwhelmed left ventricle. Arch Cardiovasc Dis. 2014;107:219–224.
  • Schievano S, Petrini L, Migliavacca F, et al. Finite element analysis of stent deployment: understanding stent fracture in percutaneous pulmonary valve implantation. J Interv Cardiol. 2007;20:546–554.
  • Gillespie MJ, Rome JJ, Levi DS, et al. Melody valve implant within failed bioprosthetic valves in the pulmonary position: a multicenter experience. Circ Cardiovasc Interv. 2012;5:862–870.
  • Boshoff DE, Cools BLM, Heying R, et al. Off-label use of percutaneous pulmonary valved stents in the right ventricular outflow tract: time to rewrite the label? Catheter Cardiovasc Interv. 2013;81:987–995.
  • Meadows JJ, Moore PM, Berman DP, et al. Use and performance of the Melody Transcatheter Pulmonary Valve in native and postsurgical, nonconduit right ventricular outflow tracts. Circ Cardiovasc Interv. 2014;7:374–380.
  • Cao Q-L, Kenny D, Zhou D, et al. Early clinical experience with a novel self-expanding percutaneous stent-valve in the native right ventricular outflow tract. Catheter Cardiovasc Interv. 2014;84:1131–1137.
  • Morray BH, McElhinney DB, Cheatham JP, et al. Risk of coronary artery compression among patients referred for transcatheter pulmonary valve implantation. Circ Cardiovasc Interv. 2013; 6.
  • Sridharan S, Coats L, Khambadkone S, et al. Transcatheter right ventricular outflow tract intervention. Circulation. 2006;113:e934-e935.
  • Lindsay I, Aboulhosn J, Salem M, et al. Aortic root compression during transcatheter pulmonary valve replacement. Catheter Cardiovasc Interv. 2016;88:814–821.
  • Biernacka EK, Rużyłło W, Demkow M, et al. Transcatheter pulmonary valve implantation in patients with right ventricular outflow tract dysfunction: early and mid-term results. J Invasive Cardiol. 2015;27:E82–E89.
  • Patel M, Malekzadeh-Milani S, Ladouceur M, et al. Percutaneous pulmonary valve endocarditis: incidence, prevention and management. Arch Cardiovasc Dis. 2014;107:615–624.
  • Lurz P, Coats L, Khambadkone S, et al. Percutaneous pulmonary valve implantation. Circulation. 2008;117:1964–1972.
  • Chen X-J, Smith PB, Jaggers J, et al. Bioprosthetic pulmonary valve replacement: contemporary analysis of a large, single-center series of 170 cases. J Thorac Cardiovasc Surg. 2013;146:1461–1466.
  • 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.
  • McElhinney DB, Benson LN, Eicken A, et al. 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.
  • 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.
  • Cheung G, Vejlstrup N, Ihlemann N, et al. Infective endocarditis following percutaneous pulmonary valve replacement: diagnostic challenges and application of intra-cardiac echocardiography. Int J Cardiol. 2013;169:425–429.
  • Villafañe J, Baker GH, Austin EH, et al. Melody ® pulmonary valve bacterial endocarditis: experience in four pediatric patients and a review of the literature. Catheter Cardiovasc Interv. 2014;84:212–218.
  • Jalal Z, Galmiche L, Lebeaux D, et al. Selective propensity of bovine jugular vein material to bacterial adhesions: an in-vitro study. Int J Cardiol. 2015;198:201–205.
  • Chatterjee A, Bajaj NS, McMahon WS, et al. Transcatheter pulmonary valve implantation: a comprehensive systematic review and meta-analyses of observational studies. J Am Heart Assoc. 2017;6:e006432.
  • Boudjemline Y, Malekzadeh-Milani S, Patel M, et al. Predictors and outcomes of right ventricular outflow tract conduit rupture during percutaneous pulmonary valve implantation: a multicentre study. EuroIntervention. 2016;11:1053–1062.
  • 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.
  • Berman DP, McElhinney DB, Vincent JA, et al. Feasibility and short-term outcomes of percutaneous transcatheter pulmonary valve replacement in small. Circ Cardiovasc Interv. 2014;7:142-148.
  • Ghawi H, Kenny D, Hijazi ZM. Transcatheter pulmonary valve replacement. Cardiol Ther. 2012;1:5.
  • Butera G, Milanesi O, Spadoni I, et al. Melody transcatheter pulmonary valve implantation. Results from the registry of the Italian society of pediatric cardiology. Catheter Cardiovasc Interv. 2013;81:310–316.
  • Ansari MM, Cardoso R, Garcia D, et al. Percutaneous pulmonary valve implantation. J Am Coll Cardiol. 2015;66:2246–2255.
  • Cosentino D, Capelli C, Pennati G, et al. 2011. Stent fracture prediction in percutaneous pulmonary valve implantation: a patient-specific finite element analysis. Berlin, Heidelberg: Springer. p. 288–293.
  • Nordmeyer J, Khambadkone S, Coats L, et al. Risk stratification, systematic classification, and anticipatory management strategies for stent fracture after percutaneous pulmonary valve implantation. Circulation. 2007;115:1392-1397.
  • Demkow M, Biernacka EK, Śpiewak M, et al. Percutaneous pulmonary valve implantation preceded by routine prestenting with a bare metal stent. Catheter Cardiovasc Interv. 2011;77:381–389.
  • Cardoso R, Ansari M, Garcia D, et al. Prestenting for prevention of melody valve stent fractures: a systematdevice with high procedure success ratesic review and meta-analysis. Catheter Cardiovasc Interv. 2016;87:534–539.
  • Cools B, Budts W, Heying R, et al. Medium term follow-up after percutaneous pulmonary valve replacement with the Melody® valve. IJC Hear Vasc. 2015;7:92–97.
  • Nordmeyer J, Lurz P, Khambadkone S, et al. Pre-stenting with a bare metal stent before percutaneous pulmonary valve implantation: acute and 1-year outcomes. Heart. 2011;97:118–123.
  • Cabalka AK, Hellenbrand WE, Eicken A, et al. Relationships among conduit type, pre-stenting, and outcomes in patients undergoing transcatheter pulmonary valve replacement in the prospective North American and European Melody valve trials. JACC Cardiovasc Interv. 2017;10:1746–1759.
  • Nordmeyer J, Lurz P, Tsang VT, et al. Effective transcatheter valve implantation after pulmonary homograft failure: a new perspective on the Ross operation. J Thorac Cardiovasc Surg. 2009;138:84–88.
  • Biernacka EK, Demkow M, Spiewak M, et al. Abstract 12657: transcatheter pulmonary valve implantation - results in 25 patients. Circulation. 2011;124:A12657.
  • Cheatham JP, Hellenbrand WE, Zahn EM, et al. Clinical and hemodynamic outcomes up to 7 years after transcatheter pulmonary valve replacement in the US melody valve investigational device exemption trial. Circulation. 2015;131:1960–1970.
  • Vezmar M, Chaturvedi R, Lee K-J, et al. Percutaneous pulmonary valve implantation in the young. JACC Cardiovasc Interv. 2010;3:439–448.
  • Coats L, Khambadkone S, Derrick G, et al. Physiological and clinical consequences of relief of right ventricular outflow tract obstruction late after repair of congenital heart defects. Circulation. 2006;113:2037–2044.
  • Coats L, Khambadkone S, Derrick G, et al. Physiological consequences of percutaneous pulmonary valve implantation: the different behaviour of volume- and pressure-overloaded ventricles. Eur Heart J. 2007;28:1886–1893.
  • Zahn EM, Hellenbrand WE, Lock JE, et al. Implantation of the melody transcatheter pulmonary valve in patients with a dysfunctional right ventricular outflow tract conduit. J Am Coll Cardiol. 2009;54:1722–1729.
  • Martins JDF, Ewert P, Sousa L, et al. Percutaneous pulmonary valve implantation: initial experience. Rev Port Cardiol. 2010;29:1839–1846.
  • Lurz P, Nordmeyer J, Giardini A, et al. Early versus late functional outcome after successful percutaneous pulmonary valve implantation. J Am Coll Cardiol. 2011;57:724–731.
  • Batra AS, McElhinney DB, Wang W, et al. Cardiopulmonary exercise function among patients undergoing transcatheter pulmonary valve implantation in the US Melody valve investigational trial. Am Heart J. 2012;163:280–287.
  • Borik S, Crean A, Horlick E, et al. Percutaneous pulmonary valve implantation: 5 years of follow-up. Circ Cardiovasc Interv. 2015;8:e001745-e001745.
  • Holzer RJ, Hijazi ZM. Transcatheter pulmonary valve replacement: state of the art. Catheter Cardiovasc Interv. 2016;87:117–128.
  • Haas NA, Moysich A, Neudorf U, et al. Percutaneous implantation of the Edwards SAPIEN TM pulmonic valve: initial results in the first 22 patients. Clin Res Cardiol. 2013;102:119–128.
  • Faza N, Kenny D, Kavinsky C, et al. Single-center comparative outcomes of the Edwards SAPIEN and medtronic melody transcatheter heart valves in the pulmonary position. Catheter Cardiovasc Interv. 2013;82:n/a-n/a.
  • Demkow M, Rużyłło W, Biernacka EK, et al. Percutaneous edwards SAPIEN TM valve implantation for significant pulmonary regurgitation after previous surgical repair with a right ventricular outflow patch. Catheter Cardiovasc Interv. 2014;83:474–481.
  • Wilson WM, Benson LN, Osten MD, et al. Transcatheter pulmonary valve replacement with the Edwards Sapien system. JACC Cardiovasc Interv. 2015;8:1819–1827.
  • Suradi HS, Hijazi ZM. Percutaneous pulmonary valve implantation. Glob Cardiol Sci Pract. 2015;2015:23.
  • COMPASSION S3 - Evaluation of the SAPIEN 3 Transcatheter Heart Valve in Patients With Pulmonary Valve Dysfunction - Full Text View - ClinicalTrials.gov [Internet]. [cited 2017 Sep 24]. Available from: https://clinicaltrials.gov/ct2/show/NCT02744677.
  • Kumar A, Kavinsky C, Amin Z, et al. Percutaneous pulmonic valve implantation. Curr Treat Options Cardiovasc Med. 2009;11:483–491.
  • Steinberg ZL, Jones TK, Verrier E, et al. Early outcomes in patients undergoing transcatheter versus surgical pulmonary valve replacement. Heart. 2017;103:1455–1460.
  • Andresen B, Mishra V, Lewandowska M, et al. In-hospital cost comparison between percutaneous pulmonary valve implantation and surgery. Eur J Cardio-Thoracic Surg. 2016;51:ezw378.
  • O’Byrne ML, Gillespie MJ, Shinohara RT, et al. Cost comparison of transcatheter and operative pulmonary valve replacement (from the Pediatric Health Information Systems Database). Am J Cardiol. 2016;117:121–126.
  • Jalal Z, Malekzadeh-Milani S, Hofbeck M, et al. A new percutaneous pulmonary valve implantation technique for complex right ventricular outflow tracts: the “Folded melody valve.”. Catheter Cardiovasc Interv. 2015;85:604–610.
  • VENUS MEDTECH-VENUS MEDTECH [Internet]. [cited 2017 Sep 24]. Available from: http://en.venusmedtech.com/products/pmcId=24.html.
  • Promphan W, Prachasilchai P, Siripornpitak S, et al. Percutaneous pulmonary valve implantation with the Venus P-valve: clinical experience and early results. Cardiol Young. 2016;26:698–710.
  • Husain J, Praichasilchai P, Gilbert Y, et al. Early European experience with the Venus P-valve®: filling the gap in percutaneous pulmonary valve implantation. EuroIntervention. 2016;12:e643–e651.
  • Garay F, Pan X, Zhang YJ, et al. Early experience with the Venus p-valve for percutaneous pulmonary valve implantation in native outflow tract. Neth Heart J. 2017;25:76–81.
  • Efficacy and Safety of Venus P-valve to Treat RVOT Stenosis With Pulmonary Regurgitation - Full Text View - ClinicalTrials.gov [Internet]. [cited 2017 Sep 24]. Available from: https://clinicaltrials.gov/ct2/show/NCT02071654.
  • The Medtronic Harmony TM Transcatheter Pulmonary Valve Clinical Study - Full Text View - ClinicalTrials.gov [Internet]. [cited 2017 Sep 27]. Available from: https://clinicaltrials.gov/ct2/show/NCT02979587.
  • Schoonbeek RC, Takebayashi S, Aoki C, et al. Implantation of the Medtronic harmony transcatheter pulmonary valve improves right ventricular size and function in an ovine model of postoperative chronic pulmonary insufficiency. Circ Cardiovasc Interv. 2016;9:e003920.
  • Bergersen L, Benson LN, Gillespie MJ, et al. Harmony feasibility trial. JACC Cardiovasc Interv. 2017;10:1763–1773.
  • Bergersen L, Benson LN, Gillespie MJ, et al. Harmony feasibility trial. Jacc Cardiovasc. Interv. 2017;10:1763–1773.

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