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Unmet Clinical Needs for Transcatheter Pulmonary Valves

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Abstract

A common feature of congenital heart disease is the presence of right ventricular outflow tract (RVOT) obstruction that can range from mild to severe and can lead to atresia of the pulmonary valve, in extreme conditions. RVOT abnormalities can frequently be corrected surgically or via interventional means. However, most of these patients will ultimately develop pulmonary valve insufficiency and eventual right ventricular dilation, which will require a pulmonary valve replacement at some point in their life to mitigate the detrimental effects of pulmonary valve regurgitation (PVR) on the right ventricle (RV). The evolution from the studies done by Philip Bonhoeffer to implant a pulmonary valve via transcatheter means, have provided a bedrock for transcatheter pulmonary valve replacement (TPVR). Yet, several areas of unmet need for a demographic of patients still exist. Here, we discuss the clinical unmet needs in children under 20 Kg and expand the use of hybrid and other TPVR approaches along with the current indications and contraindications for pulmonary valve replacement. The constraints and limitations from commercially available pulmonary valves will be discussed from a clinical standpoint. Finally, we explore the use of hybrid and periventricular delivery of transcatheter pulmonary valves in younger patients.

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References

  1. Abdelghani, M., M. Nassif, N. A. Blom, M. S. Van Mourik, B. Straver, D. R. Koolbergen, J. Kluin, J. G. Tijssen, B. J. M. Mulder, B. J. Bouma, and R. J. de Winter. Infective endocarditis after melody valve implantation in the pulmonary position: a systematic review. J. Am. Heart Assoc.7:e008163, 2018.

    PubMed  PubMed Central  Google Scholar 

  2. Alkashkari, W., S. Albugami, M. Abbadi, A. Niyazi, A. Alsubei, and Z. M. Hijazi. Transcatheter pulmonary valve replacement in pediatric patients. Expert Rev. Med. Devices. 17:541–554, 2020.

    CAS  PubMed  Google Scholar 

  3. Armstrong, A. K., F. Berger, T. K. Jones, J. W. Moore, L. N. Benson, J. P. Cheatham, D. R. Turner, J. F. Rhodes, J. A. Vincent, T. Zellers, T.-H. Lung, A. Eicken, and D. B. McElhinney. Association between patient age at implant and outcomes after transcatheter pulmonary valve replacement in the multicenter Melody valve trials. Catheter. Cardiovasc. Interv. 94(4):607–617, 2019.

    PubMed  Google Scholar 

  4. Bartra, S. Transcatheter pulmonary valve replacement in patients with congenital heart disease. Critical Care Nurse. 38:30–36, 2018.

    PubMed  Google Scholar 

  5. Benson, L. N., M. J. Gillespie, L. Bergersen, S. L. Cheatham, K. N. Hor, E. M. Horlick, S. Weng, B. T. McHenry, M. D. Osten, A. J. Powell, and J. P. Cheatham. Three-year outcomes from the harmony native outflow tract early feasibility study. Circulation. 13:e008320, 2020.

    PubMed  Google Scholar 

  6. Berman, D. P., D. B. McElhinney, J. A. Vincent, W. E. Hellenbrand, and E. M. Zahn. Feasibility and short-term outcomes of percutaneous transcatheter pulmonary valve replacement in small (<30 kg) children with dysfunctional right ventricular outflow tract conduits. Circulation. 7:142–148, 2014.

    PubMed  Google Scholar 

  7. Best, K. E., and J. Rankin. Long-term survival of individuals born with congenital heart disease: a systematic review and meta-analysis. J. Am. Heart Assoc.5:e002846, 2016.

    PubMed  PubMed Central  Google Scholar 

  8. Boe, B. A., S. L. Cheatham, A. K. Armstrong, D. P. Berman, J. L. Chisolm, and J. P. Cheatham. Leaflet morphology classification of the Melody Transcatheter Pulmonary Valve. Congenital Heart Dis. 14:297–304, 2019.

    Google Scholar 

  9. Bonhoeffer, P., Y. Boudjemline, Z. Saliba, J. Merckx, Y. Aggoun, D. Bonnet, P. Acar, J. Le Bidois, D. Sidi, and J. Kachaner. Percutaneous replacement of pulmonary valve in a right-ventricle to pulmonary-artery prosthetic conduit with valve dysfunction. The Lancet. 356:1403–1405, 2000.

    CAS  Google Scholar 

  10. Cabalka, A. K., J. D. Asnes, D. T. Balzer, J. P. Cheatham, M. J. Gillespie, T. K. Jones, H. Justino, D. W. Kim, T.-H. Lung, D. R. Turner, and D. B. McElhinney. Transcatheter pulmonary valve replacement using the melody valve for treatment of dysfunctional surgical bioprostheses: a multicenter study. J. Thorac. Cardiovasc. Surg. 155:1712-1724.e1711, 2018.

    PubMed  Google Scholar 

  11. Cabalka, A. K., W. E. Hellenbrand, A. Eicken, J. Kreutzer, R. G. Gray, L. Bergersen, F. Berger, A. K. Armstrong, J. P. Cheatham, E. M. Zahn, and D. B. McElhinney. 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. Cardiovasc. Interv. 10:1746–1759, 2017.

    Google Scholar 

  12. Cho, Y. K., and J. S. Ma. Right ventricular failure in congenital heart disease. Korean J Pediatrics. 56:101–106, 2013.

    Google Scholar 

  13. Class 1 Device Recall Harmony Delivery Catheter System.

  14. Dohlen, G., R. R. Chaturvedi, L. N. Benson, A. Ozawa, G. S. Van Arsdell, D. S. Fruitman, and K. J. Lee. Stenting of the right ventricular outflow tract in the symptomatic infant with tetralogy of Fallot. Heart. 95:142–147, 2009.

    CAS  PubMed  Google Scholar 

  15. Dolk, H., M. Loane, and E. Garne. Congenital heart defects in Europe. Circulation. 123:841–849, 2011.

    PubMed  Google Scholar 

  16. Esmaeili A., M. Khalil, K. Behnke-Hall, M. B. Gonzalez Y Gonzalez, G. Kerst, S. Fichtlscherer, H. Akintuerk, and D. Schranz. Percutaneous pulmonary valve implantation (PPVI) in non-obstructive right ventricular outflow tract: limitations and mid-term outcomes. Translational Pediatrics 8:107–113, 2019.

  17. Gatzoulis, M. A., S. Balaji, S. A. Webber, S. C. Siu, J. S. Hokanson, C. Poile, M. Rosenthal, M. Nakazawa, J. H. Moller, P. C. Gillette, G. D. Webb, and A. N. Redington. Risk factors for arrhythmia and sudden cardiac death late after repair of tetralogy of Fallot: a multicentre study. The Lancet. 356:975–981, 2000.

    CAS  Google Scholar 

  18. Gilboa, S. M., O. J. Devine, J. E. Kucik, M. E. Oster, T. Riehle-Colarusso, W. N. Nembhard, P. Xu, A. Correa, K. Jenkins, and A. J. Marelli. Congenital heart defects in the United States. Circulation. 134:101–109, 2016.

    PubMed  PubMed Central  Google Scholar 

  19. Güzeltaş, A. Implantation of the Edwards SAPIEN XT and SAPIEN 3 valves for pulmonary position in enlarged native right ventricular outflow tract. Anatolian J. Cardiol. 25:96, 2020.

    Google Scholar 

  20. Haas, N. A., R. G. Carere, O. Kretschmar, E. Horlick, J. Rodés-Cabau, D. de Wolf, M. Gewillig, M. Mullen, A. Lehner, C. Deutsch, P. Bramlage, and P. Ewert. Early outcomes of percutaneous pulmonary valve implantation using the Edwards SAPIEN XT transcatheter heart valve system. Int. J. Cardiol. 250:86–91, 2018.

    PubMed  Google Scholar 

  21. Haddad, F., R. Doyle, D. J. Murphy, and S. A. Hunt. Right ventricular function in cardiovascular disease, Part II. Circulation. 117:1717–1731, 2008.

    PubMed  Google Scholar 

  22. Hascoet, S., R. Dalla Pozza, J. Bentham, R. G. Carere, M. Kanaan, P. Ewert, E. K. Biernacka, O. Kretschmar, C. Deutsch, F. Lecerf, A. Lehner, M. Kantzis, J. Kurucova, M. Thoenes, P. Bramlage, and N. A. Haas. Early outcomes of percutaneous pulmonary valve implantation using the Edwards SAPIEN 3 transcatheter heart valve system. EuroIntervention. 14:1378–1385, 2019.

    PubMed  Google Scholar 

  23. Hoffman, J. I. E., and S. Kaplan. The incidence of congenital heart disease. J. Am. Coll. Cardiol. 39:1890–1900, 2002.

    PubMed  Google Scholar 

  24. Jones, T. K., D. B. McElhinney, J. A. Vincent, W. E. Hellenbrand, J. P. Cheatham, D. P. Berman, E. M. Zahn, D. M. Khan, J. F. Rhodes, S. Weng, and L. J. Bergersen. Long-term outcomes after melody transcatheter pulmonary valve replacement in the US investigational device exemption trial. Circulation. 15:e010852, 2022.

    PubMed  Google Scholar 

  25. Kenny, D., J. F. Rhodes, G. A. Fleming, S. Kar, E. M. Zahn, J. Vincent, G. S. Shirali, J. Gorelick, M. A. Fogel, J. T. Fahey, D. W. Kim, V. C. Babaliaros, A. K. Armstrong, and Z. M. Hijazi. 3-year outcomes of the Edwards SAPIEN transcatheter heart valve for conduit failure in the pulmonary position from the compassion multicenter clinical trial. Cardiovasc. Interv. 11:1920–1929, 2018.

    Google Scholar 

  26. Khambadkone, S., L. Coats, A. Taylor, Y. Boudjemline, G. Derrick, V. Tsang, J. Cooper, V. Muthurangu, S. R. Hegde, R. S. Razavi, D. Pellerin, J. Deanfield, and P. Bonhoeffer. Percutaneous pulmonary valve implantation in humans. Circulation. 112:1189–1197, 2005.

    PubMed  Google Scholar 

  27. Kim, A. Y., J. W. Jung, S. Y. Jung, J. I. Shin, L. Y. Eun, N. K. Kim, and J. Y. Choi. Early outcomes of percutaneous pulmonary valve implantation with pulsta and melody valves: the first report from korea. J. Clin. Med. 9:1–14, 2020.

    Google Scholar 

  28. Labs D. Pediatric Heart Valve | Draper. 2022.

  29. Le Ruz, R., J. Plessis, A. Houeijeh, A. E. Baruteau, L. Le Gloan, K. WarinFresse, C. Karsenty, J. Petit, F. Godart, S. Hascoët, and P. Guérin. Edwards SAPIEN XT transcatheter pulmonary valve implantation: 5-year follow-up in a French Registry. Catheter. Cardiovasc. Interv. 98:990–999, 2021.

    PubMed  Google Scholar 

  30. Lindsey, C. W., W. J. Parks, B. E. Kogon, D. Sallee, and W. T. Mahle. Pulmonary valve replacement after tetralogy of Fallot repair in preadolescent patients. Ann. Thorac. Surg. 89:147–151, 2010.

    PubMed  Google Scholar 

  31. Liu, Y., S. Chen, L. Zühlke, G. C. Black, M.-K. Choy, N. Li, and B. D. Keavney. Global birth prevalence of congenital heart defects 1970–2017: updated systematic review and meta-analysis of 260 studies. Int. J. Epidemiol. 48:455–463, 2019.

    PubMed  PubMed Central  Google Scholar 

  32. Loverix, L., T. Juvonen, and F. Biancari. Prosthetic endocarditis after transcatheter aortic valve implantation: pooled individual patient outcome. Int. J. Cardiol. 178:67–68, 2015.

    PubMed  Google Scholar 

  33. Martin, M. H., J. Meadows, D. B. McElhinney, B. H. Goldstein, L. Bergersen, A. M. Qureshi, S. Shahanavaz, J. Aboulhosn, D. Berman, L. Peng, M. Gillespie, A. Armstrong, C. Weng, L. L. Minich, and R. G. Gray. Safety and feasibility of melody transcatheter pulmonary valve replacement in the native right ventricular outflow tract. Cardiovasc. Interv. 11:1642–1650, 2018.

    Google Scholar 

  34. Martin, M. H., S. Shahanavaz, L. F. Peng, J. D. Asnes, M. Riley, W. E. Hellenbrand, D. T. Balzer, R. G. Gray, and D. B. McElhinney. Percutaneous transcatheter pulmonary valve replacement in children weighing less than 20 kg. Catheter. Cardiovasc. Interv. 91:485–494, 2018.

    PubMed  Google Scholar 

  35. McElhinney, D. B., J. P. Cheatham, T. K. Jones, J. E. Lock, J. A. Vincent, E. M. Zahn, and W. E. Hellenbrand. 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. 4:602–614, 2011.

    PubMed  Google Scholar 

  36. McElhinney, D. B., and J. T. Hennesen. The Melody® valve and Ensemble® delivery system for transcatheter pulmonary valve replacement. Ann. N. Y. Acad. Sci. 1291:77–85, 2013.

    CAS  PubMed  PubMed Central  Google Scholar 

  37. Mery, C. M., F. A. Guzmán-Pruneda, L. E. De León, W. Zhang, M. D. Terwelp, C. E. Bocchini, I. Adachi, J. S. Heinle, E. D. McKenzie, and C. D. Fraser Jr. Risk factors for development of endocarditis and reintervention in patients undergoing right ventricle to pulmonary artery valved conduit placement. J. Thorac. Cardiovasc. Surg. 151:432–439, 2016.

    PubMed  Google Scholar 

  38. Mitropoulos, F. M., M. A. Kanakis, C. Ntellos, C. Loukas, P. Davlouros, T. Kousi, and A. C. Chatzis. Pulmonary valve replacement in patients with corrected tetralogy of Fallot. J. Cardiovasc. Thorac. Res. 9:71–77, 2017.

    PubMed  PubMed Central  Google Scholar 

  39. Morray, B. H., and D. B. McElhinney. Updates on transcatheter pulmonary valve replacement. Prog. Pediatric Cardiol. 61:101345–101345, 2021.

    Google Scholar 

  40. Nordmeyer, J., P. Ewert, M. Gewillig, M. AlJufan, M. Carminati, O. Kretschmar, A. Uebing, I. Dähnert, R. Röhle, H. Schneider, M. Witsenburg, L. Benson, R. Gitter, R. Bökenkamp, V. Mahadevan, and F. Berger. Acute and midterm outcomes of the post-approval MELODY registry: a multicentre registry of transcatheter pulmonary valve implantation. Eur. Heart J. 40:2255–2264, 2019.

    PubMed  Google Scholar 

  41. O’Byrne, M. L., A. C. Glatz, L. Mercer-Rosa, M. J. Gillespie, Y. Dori, E. Goldmuntz, S. Kawut, and J. J. Rome. Trends in pulmonary valve replacement in children and adults with tetralogy of Fallot. Am. J. Cardiol. 115:118–124, 2015.

    PubMed  Google Scholar 

  42. Oster, M. E., K. A. Lee, M. A. Honein, T. Riehle-Colarusso, M. Shin, and A. Correa. Temporal trends in survival among infants with critical congenital heart defects. Pediatrics. 131:e1502–e1508, 2013.

    PubMed  Google Scholar 

  43. Patel, N. D., D. S. Levi, J. P. Cheatham, S. A. Qureshi, S. Shahanavaz, and E. M. Zahn. Transcatheter pulmonary valve replacement: a review of current valve technologies. J. Soc. Cardiovasc. Angiography Interv. 1:100452–100452, 2022.

    Google Scholar 

  44. Premarket Approval (PMA)- Harmony™ Delivery Catheter System. 2023.

  45. Premarket Approval (PMA)- Harmony™ Transcatheter Pulmonary Valve, Harmony™ Delivery Catheter System. 2023.

  46. Puls, M., H. Eiffert, M. Hünlich, F. Schöndube, G. Hasenfuß, R. Seipelt, and W. Schillinger. Prosthetic valve endocarditis after transcatheter aortic valve implantation: the incidence in a single-centre cohort and reflections on clinical, echocardiographic and prognostic features. EuroIntervention. 8:1407–1418, 2013.

    PubMed  Google Scholar 

  47. Reller, M. D., M. J. Strickland, T. Riehle-Colarusso, W. T. Mahle, and A. Correa. Prevalence of congenital heart defects in metropolitan Atlanta, 1998–2005. J. Pediatrics. 153:807–813, 2008.

    Google Scholar 

  48. Rheude, T., J. Blumenstein, H. Möllmann, and O. Husser. Spotlight on the SAPIEN 3 transcatheter heart valve. Med. Devices. 11:353–360, 2018.

    Google Scholar 

  49. Rockefeller, T., S. Shahanavaz, A. Zajarias, and D. Balzer. Pediatric And congenital heart disease case report transcatheter implantation of SAPIEN 3 valve in native right ventricular outflow tract for severe pulmonary regurgitation following tetralogy of Fallot repair. Catheter. Cardiovasc. Interv. 88(1):E28–E33, 2016.

    PubMed  Google Scholar 

  50. Ruiz, C. E., and T. K. R. Pasala. Are we ready for transcatheter pulmonary valve replacement in native right ventricular outflow tract? Cardiovasc. Interv. 11:1651–1653, 2018.

    Google Scholar 

  51. Sandoval, J. P., R. R. Chaturvedi, L. Benson, G. Morgan, G. Van Arsdell, O. Honjo, C. Caldarone, and K.-J. Lee. Right ventricular outflow tract stenting in tetralogy of Fallot infants with risk factors for early primary repair. Circulation.9:e003979, 2016.

    PubMed  Google Scholar 

  52. Shahanavaz, S., E. M. Zahn, D. S. Levi, J. A. Aboulhousn, S. Hascoet, A. M. Qureshi, D. Porras, G. J. Morgan, H. Bauser Heaton, M. H. Martin, B. Keeshan, J. D. Asnes, D. Kenny, J. M. Ringewald, J. E. Zablah, M. Ivy, B. H. Morray, A. J. Torres, D. P. Berman, M. J. Gillespie, K. Chaszczewski, J. D. Zampi, K. P. Walsh, P. Julien, B. H. Goldstein, S. K. Sathanandam, C. Karsenty, D. T. Balzer, and D. B. McElhinney. Transcatheter pulmonary valve replacement with the sapien prosthesis. J. Am. Coll. Cardiol. 76:2847–2858, 2020.

    PubMed  Google Scholar 

  53. Shibbani, K., J. Aboulhosn, D. Levi, B. Mohammad Nijres, B. Blais, M. Karimi, G. Van Arsdell, and O. Aldoss. Hybrid approach for harmony transcatheter pulmonary valve replacement. Catheter. Cardiovasc. Interv. 101:135–139, 2023.

    PubMed  Google Scholar 

  54. Sinha, S., J. Aboulhosn, J. Asnes, M. Bocks, E. Zahn, B. H. Goldstein, J. Zampi, W. Hellenbrand, M. Salem, and D. Levi. Initial results from the off-label use of the SAPIEN S3 valve for percutaneous transcatheter pulmonary valve replacement: a multi-institutional experience. Catheter. Cardiovasc. Interv. 93:455–463, 2019.

    PubMed  Google Scholar 

  55. Tanase, D., S. Georgiev, A. Eicken, and P. Ewert. The Sapien valve provides enough grip to be implanted in pulmonary position without a pre-stent. Cardiovasc. Diagn. Ther. 9:S264–S268, 2019.

    PubMed  PubMed Central  Google Scholar 

  56. Tezza, M., M. Witsenburg, K. Nieman, P. C. van de Woestijne, and R. P. J. Budde. Cardiac CT to assess the risk of coronary compression in patients evaluated for percutaneous pulmonary valve implantation. Eur. J. Radiol. 110:88–96, 2019.

    PubMed  Google Scholar 

  57. Toggweilera, S., and J. G. Webb. Challenges in transcatheter aortic valve implantation. Swiss Med. Weekly. 142:W13735, 2012.

    Google Scholar 

  58. Tweddell, J. S., P. Simpson, S.-H. Li, J. Dunham-Ingle, P. J. Bartz, M. G. Earing, and A. N. Pelech. Timing and technique of pulmonary valve replacement in the patient with tetralogy of Fallot. Semin. Thorac. Cardiovasc. Surg. 15:27–33, 2012.

    Google Scholar 

  59. Voelkel, N. F., R. A. Quaife, L. A. Leinwand, R. J. Barst, M. D. McGoon, D. R. Meldrum, J. Dupuis, C. S. Long, L. J. Rubin, F. W. Smart, Y. J. Suzuki, M. Gladwin, E. M. Denholm, and D. B. Gail. Right ventricular function and failure. Circulation. 114:1883–1891, 2006.

    PubMed  Google Scholar 

  60. Warner, K. G., P. K. H. O’Brien, J. Rhodes, A. Kaur, D. A. Robinson, and D. D. Payne. Expanding the indications for pulmonary valve replacement after repair of tetralogy of Fallot. Ann. Thorac. Surg. 76:1066–1071, 2003.

    PubMed  Google Scholar 

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Funding

This work is funded by a National Science Foundation Grant 2109959 and NIH Grants 1R21 HD105889-01, 1 R01 HL162687-01A1, 1 R01 HL157631-01A1, and 1R01 HL153724-01A1.

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  1. Department of Biomedical Engineering, University of California, 2420 Engineering Hall, Irvine, CA, 92697-2730, USA

    Nnaoma Agwu & Arash Kheradvar

  2. Children Hospital of Orange County, Orange, CA, USA

    Michael R. Recto

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Agwu, N., Recto, M.R. & Kheradvar, A. Unmet Clinical Needs for Transcatheter Pulmonary Valves. Ann Biomed Eng 51, 2384–2392 (2023). https://doi.org/10.1007/s10439-023-03328-5

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