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Published in: The International Journal of Cardiovascular Imaging 8/2011

01-12-2011 | Review

Clinical trial experience with transcatheter aortic valve insertion

Authors: Thomas J. Helton, Samir R. Kapadia, E. Murat Tuzcu

Published in: The International Journal of Cardiovascular Imaging | Issue 8/2011

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Abstract

Surgical aortic valve replacement has long been considered the standard of care for patients with severe symptomatic aortic stenosis, however, an aging population with increasing complex comorbidities now represents a growing population of patients that is often considered inoperable for a traditional surgical approach. Transcatheter aortic valve implantation is a developing technology that offers an alternative treatment modality for these very high risk patients. This manuscript will review the currently available clinical trial data with transcatheter aortic valve implantation and offer perspective as to the future of this novel technology.
Literature
1.
go back to reference Iung B, Cachier A, Baron G, Messika-Zeitoun D, Delahaye F, Tornos P, Gohlke-Barwolf C, Boersma E, Ravaud P, Vahanian A (2005) Decision-making in elderly patients with severe aortic stenosis: why are so many denied surgery? Eur Heart J 26(24):2714–2720PubMedCrossRef Iung B, Cachier A, Baron G, Messika-Zeitoun D, Delahaye F, Tornos P, Gohlke-Barwolf C, Boersma E, Ravaud P, Vahanian A (2005) Decision-making in elderly patients with severe aortic stenosis: why are so many denied surgery? Eur Heart J 26(24):2714–2720PubMedCrossRef
2.
go back to reference Pai RG, Kapoor N, Bansal RC, Varadarajan P (2006) Malignant natural history of asymptomatic severe aortic stenosis: benefit of aortic valve replacement. Ann Thorac Surg 82(6):2116–2122PubMedCrossRef Pai RG, Kapoor N, Bansal RC, Varadarajan P (2006) Malignant natural history of asymptomatic severe aortic stenosis: benefit of aortic valve replacement. Ann Thorac Surg 82(6):2116–2122PubMedCrossRef
3.
go back to reference Varadarajan P, Kapoor N, Bansal RC, Pai RG (2006) Clinical profile and natural history of 453 nonsurgically managed patients with severe aortic stenosis. Ann Thorac Surg 82(6):2111–2115PubMedCrossRef Varadarajan P, Kapoor N, Bansal RC, Pai RG (2006) Clinical profile and natural history of 453 nonsurgically managed patients with severe aortic stenosis. Ann Thorac Surg 82(6):2111–2115PubMedCrossRef
4.
go back to reference Bouma BJ, van Den Brink RB, van Der Meulen JH, Verheul HA, Cheriex EC, Hamer HP, Dekker E, Lie KI, Tijssen JG (1999) To operate or not on elderly patients with aortic stenosis: the decision and its consequences. Heart 82(2):143–148PubMed Bouma BJ, van Den Brink RB, van Der Meulen JH, Verheul HA, Cheriex EC, Hamer HP, Dekker E, Lie KI, Tijssen JG (1999) To operate or not on elderly patients with aortic stenosis: the decision and its consequences. Heart 82(2):143–148PubMed
5.
go back to reference Bach DS, Cimino N, Deeb GM (2007) Unoperated patients with severe aortic stenosis. J Am Coll Cardiol 50(20):2018–2019PubMedCrossRef Bach DS, Cimino N, Deeb GM (2007) Unoperated patients with severe aortic stenosis. J Am Coll Cardiol 50(20):2018–2019PubMedCrossRef
6.
go back to reference Cribier A, Eltchaninoff H, Bash A, Borenstein N, Tron C, Bauer F, Derumeaux G, Anselme F, Laborde F, Leon MB (2002) Percutaneous transcatheter implantation of an aortic valve prosthesis for calcific aortic stenosis: first human case description. Circulation 106(24):3006–3008PubMedCrossRef Cribier A, Eltchaninoff H, Bash A, Borenstein N, Tron C, Bauer F, Derumeaux G, Anselme F, Laborde F, Leon MB (2002) Percutaneous transcatheter implantation of an aortic valve prosthesis for calcific aortic stenosis: first human case description. Circulation 106(24):3006–3008PubMedCrossRef
7.
go back to reference Cribier A, Eltchaninoff H, Tron C, Bauer F, Agatiello C, Sebagh L, Bash A, Nusimovici D, Litzler PY, Bessou JP, Leon MB (2004) Early experience with percutaneous transcatheter implantation of heart valve prosthesis for the treatment of end-stage inoperable patients with calcific aortic stenosis. J Am Coll Cardiol 43(4):698–703PubMedCrossRef Cribier A, Eltchaninoff H, Tron C, Bauer F, Agatiello C, Sebagh L, Bash A, Nusimovici D, Litzler PY, Bessou JP, Leon MB (2004) Early experience with percutaneous transcatheter implantation of heart valve prosthesis for the treatment of end-stage inoperable patients with calcific aortic stenosis. J Am Coll Cardiol 43(4):698–703PubMedCrossRef
8.
go back to reference Kapadia SR, Tuzcu EM (2009) Transcatheter aortic valve implantation. Curr Treat Options Cardiovasc Med 11(6):467–475PubMedCrossRef Kapadia SR, Tuzcu EM (2009) Transcatheter aortic valve implantation. Curr Treat Options Cardiovasc Med 11(6):467–475PubMedCrossRef
9.
go back to reference Webb JG, Altwegg L, Masson JB, Al Bugami S, Al Ali A, Boone RA (2009) A new transcatheter aortic valve and percutaneous valve delivery system. J Am Coll Cardiol 53(20):1855–1858PubMedCrossRef Webb JG, Altwegg L, Masson JB, Al Bugami S, Al Ali A, Boone RA (2009) A new transcatheter aortic valve and percutaneous valve delivery system. J Am Coll Cardiol 53(20):1855–1858PubMedCrossRef
10.
go back to reference Andersen HR, Knudsen LL, Hasenkam JM (1992) 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 13(5):704–708PubMed Andersen HR, Knudsen LL, Hasenkam JM (1992) 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 13(5):704–708PubMed
11.
go back to reference Cribier A, Eltchaninoff H, Tron C, Bauer F, Agatiello C, Nercolini D, Tapiero S, Litzler PY, Bessou JP, Babaliaros V (2006) Treatment of calcific aortic stenosis with the percutaneous heart valve: mid-term follow-up from the initial feasibility studies: the French experience. J Am Coll Cardiol 47(6):1214–1223PubMedCrossRef Cribier A, Eltchaninoff H, Tron C, Bauer F, Agatiello C, Nercolini D, Tapiero S, Litzler PY, Bessou JP, Babaliaros V (2006) Treatment of calcific aortic stenosis with the percutaneous heart valve: mid-term follow-up from the initial feasibility studies: the French experience. J Am Coll Cardiol 47(6):1214–1223PubMedCrossRef
12.
go back to reference Zajarias A, Cribier AG (2009) Outcomes and safety of percutaneous aortic valve replacement. J Am Coll Cardiol 53(20):1829–1836PubMedCrossRef Zajarias A, Cribier AG (2009) Outcomes and safety of percutaneous aortic valve replacement. J Am Coll Cardiol 53(20):1829–1836PubMedCrossRef
13.
go back to reference Krishnaswamy A, Tuzcu EM, Kapadia SR (2010) Update on transcatheter aortic valve implantation. Curr Cardiol Rep 12(5):393–403PubMedCrossRef Krishnaswamy A, Tuzcu EM, Kapadia SR (2010) Update on transcatheter aortic valve implantation. Curr Cardiol Rep 12(5):393–403PubMedCrossRef
14.
go back to reference Rodes-Cabau J, Webb JG, Cheung A, Ye J, Dumont E, Feindel CM, Osten M, Natarajan MK, Velianou JL, Martucci G, DeVarennes B, Chisholm R, Peterson MD, Lichtenstein SV, Nietlispach F, Doyle D, DeLarochelliere R, Teoh K, Chu V, Dancea A, Lachapelle K, Cheema A, Latter D, Horlick E (2010) Transcatheter aortic valve implantation for the treatment of severe symptomatic aortic stenosis in patients at very high or prohibitive surgical risk: acute and late outcomes of the multicenter Canadian experience. J Am Coll Cardiol 55(11):1080–1090PubMedCrossRef Rodes-Cabau J, Webb JG, Cheung A, Ye J, Dumont E, Feindel CM, Osten M, Natarajan MK, Velianou JL, Martucci G, DeVarennes B, Chisholm R, Peterson MD, Lichtenstein SV, Nietlispach F, Doyle D, DeLarochelliere R, Teoh K, Chu V, Dancea A, Lachapelle K, Cheema A, Latter D, Horlick E (2010) Transcatheter aortic valve implantation for the treatment of severe symptomatic aortic stenosis in patients at very high or prohibitive surgical risk: acute and late outcomes of the multicenter Canadian experience. J Am Coll Cardiol 55(11):1080–1090PubMedCrossRef
15.
go back to reference Thomas M, Schymik G, Walther T, Himbert D, Lefevre T, Treede H, Eggebrecht H, Rubino P, Michev I, Lange R, Anderson WN, Wendler O (2010) Thirty-day results of the SAPIEN aortic Bioprosthesis European Outcome (SOURCE) Registry: A European registry of transcatheter aortic valve implantation using the Edwards SAPIEN valve. Circulation 122(1):62–69PubMedCrossRef Thomas M, Schymik G, Walther T, Himbert D, Lefevre T, Treede H, Eggebrecht H, Rubino P, Michev I, Lange R, Anderson WN, Wendler O (2010) Thirty-day results of the SAPIEN aortic Bioprosthesis European Outcome (SOURCE) Registry: A European registry of transcatheter aortic valve implantation using the Edwards SAPIEN valve. Circulation 122(1):62–69PubMedCrossRef
16.
go back to reference Lichtenstein SV, Cheung A, Ye J, Thompson CR, Carere RG, Pasupati S, Webb JG (2006) Transapical transcatheter aortic valve implantation in humans: initial clinical experience. Circulation 114(6):591–596PubMedCrossRef Lichtenstein SV, Cheung A, Ye J, Thompson CR, Carere RG, Pasupati S, Webb JG (2006) Transapical transcatheter aortic valve implantation in humans: initial clinical experience. Circulation 114(6):591–596PubMedCrossRef
17.
go back to reference Svensson LG, Dewey T, Kapadia S, Roselli EE, Stewart A, Williams M, Anderson WN, Brown D, Leon M, Lytle B, Moses J, Mack M, Tuzcu M, Smith C (2008) United States feasibility study of transcatheter insertion of a stented aortic valve by the left ventricular apex. Ann Thorac Surg 86(1):46–54; discussion 54–45 Svensson LG, Dewey T, Kapadia S, Roselli EE, Stewart A, Williams M, Anderson WN, Brown D, Leon M, Lytle B, Moses J, Mack M, Tuzcu M, Smith C (2008) United States feasibility study of transcatheter insertion of a stented aortic valve by the left ventricular apex. Ann Thorac Surg 86(1):46–54; discussion 54–45
18.
go back to reference Lefevre T, Kappetein AP, Wolner E, Nataf P, Thomas M, Schachinger V, De Bruyne B, Eltchaninoff H, Thielmann M, Himbert D, Romano M, Serruys P, Wimmer-Greinecker G (2010) One year follow-up of the multi-centre European PARTNER transcatheter heart valve study. Eur Heart J Lefevre T, Kappetein AP, Wolner E, Nataf P, Thomas M, Schachinger V, De Bruyne B, Eltchaninoff H, Thielmann M, Himbert D, Romano M, Serruys P, Wimmer-Greinecker G (2010) One year follow-up of the multi-centre European PARTNER transcatheter heart valve study. Eur Heart J
19.
go back to reference Walther T, Kasimir MT, Doss M, Schuler G, Simon P, Schachinger V, Mohr FW, Wimmer-Greinecker G (2010) One-year interim follow-up results of the TRAVERCE trial: the initial feasibility study for trans-apical aortic-valve implantation. Eur J Cardiothorac Surg Walther T, Kasimir MT, Doss M, Schuler G, Simon P, Schachinger V, Mohr FW, Wimmer-Greinecker G (2010) One-year interim follow-up results of the TRAVERCE trial: the initial feasibility study for trans-apical aortic-valve implantation. Eur J Cardiothorac Surg
20.
go back to reference The heart.org (2008) Low 30-day and six-month mortality for transfemoral valve implantation in PARTNERS EU and SOURCE The heart.org (2008) Low 30-day and six-month mortality for transfemoral valve implantation in PARTNERS EU and SOURCE
21.
go back to reference Grube E, Laborde JC, Gerckens U, Felderhoff T, Sauren B, Buellesfeld L, Mueller R, Menichelli M, Schmidt T, Zickmann B, Iversen S, Stone GW (2006) Percutaneous implantation of the CoreValve self-expanding valve prosthesis in high-risk patients with aortic valve disease: the Siegburg first-in-man study. Circulation 114(15):1616–1624PubMedCrossRef Grube E, Laborde JC, Gerckens U, Felderhoff T, Sauren B, Buellesfeld L, Mueller R, Menichelli M, Schmidt T, Zickmann B, Iversen S, Stone GW (2006) Percutaneous implantation of the CoreValve self-expanding valve prosthesis in high-risk patients with aortic valve disease: the Siegburg first-in-man study. Circulation 114(15):1616–1624PubMedCrossRef
22.
go back to reference Grube E, Schuler G, Buellesfeld L, Gerckens U, Linke A, Wenaweser P, Sauren B, Mohr FW, Walther T, Zickmann B, Iversen S, Felderhoff T, Cartier R, Bonan R (2007) Percutaneous aortic valve replacement for severe aortic stenosis in high-risk patients using the second- and current third-generation self-expanding CoreValve prosthesis: device success and 30-day clinical outcome. J Am Coll Cardiol 50(1):69–76PubMedCrossRef Grube E, Schuler G, Buellesfeld L, Gerckens U, Linke A, Wenaweser P, Sauren B, Mohr FW, Walther T, Zickmann B, Iversen S, Felderhoff T, Cartier R, Bonan R (2007) Percutaneous aortic valve replacement for severe aortic stenosis in high-risk patients using the second- and current third-generation self-expanding CoreValve prosthesis: device success and 30-day clinical outcome. J Am Coll Cardiol 50(1):69–76PubMedCrossRef
23.
go back to reference Fraccaro C, Napodano M, Tarantini G, Gasparetto V, Gerosa G, Bianco R, Bonato R, Pittarello D, Isabella G, Iliceto S, Ramondo A (2009) Expanding the eligibility for transcatheter aortic valve implantation the trans-subclavian retrograde approach using: the III generation CoreValve revalving system. JACC Cardiovasc Interv 2(9):828–833PubMedCrossRef Fraccaro C, Napodano M, Tarantini G, Gasparetto V, Gerosa G, Bianco R, Bonato R, Pittarello D, Isabella G, Iliceto S, Ramondo A (2009) Expanding the eligibility for transcatheter aortic valve implantation the trans-subclavian retrograde approach using: the III generation CoreValve revalving system. JACC Cardiovasc Interv 2(9):828–833PubMedCrossRef
24.
go back to reference Petronio AS, De Carlo M, Bedogni F, Marzocchi A, Klugmann S, Maisano F, Ramondo A, Ussia GP, Ettori F, Poli A, Brambilla N, Saia F, De Marco F, Colombo A (2010) Safety and efficacy of the subclavian approach for transcatheter aortic valve implantation with the CoreValve revalving system. Circ Cardiovasc Interv 3(4):359–366PubMedCrossRef Petronio AS, De Carlo M, Bedogni F, Marzocchi A, Klugmann S, Maisano F, Ramondo A, Ussia GP, Ettori F, Poli A, Brambilla N, Saia F, De Marco F, Colombo A (2010) Safety and efficacy of the subclavian approach for transcatheter aortic valve implantation with the CoreValve revalving system. Circ Cardiovasc Interv 3(4):359–366PubMedCrossRef
25.
go back to reference JC. L Transcatheter aortic valve implantation with the CoreValve ReValving Device. In: Transcatheter cardiovascular therapeutics, Washington, 12th Oct 2008 JC. L Transcatheter aortic valve implantation with the CoreValve ReValving Device. In: Transcatheter cardiovascular therapeutics, Washington, 12th Oct 2008
26.
go back to reference Leon MB, Smith CR, Mack M, Miller DC, Moses JW, Svensson LG, Tuzcu EM, Webb JG, Fontana GP, Makkar RR, Brown DL, Block PC, Guyton RA, Pichard AD, Bavaria JE, Herrmann HC, Douglas PS, Petersen JL, Akin JJ, Anderson WN, Wang D, Pocock S (2010) Transcatheter aortic-valve implantation for aortic stenosis in patients who cannot undergo surgery. N Engl J Med 363 (17):1597–1607 Leon MB, Smith CR, Mack M, Miller DC, Moses JW, Svensson LG, Tuzcu EM, Webb JG, Fontana GP, Makkar RR, Brown DL, Block PC, Guyton RA, Pichard AD, Bavaria JE, Herrmann HC, Douglas PS, Petersen JL, Akin JJ, Anderson WN, Wang D, Pocock S (2010) Transcatheter aortic-valve implantation for aortic stenosis in patients who cannot undergo surgery. N Engl J Med 363 (17):1597–1607
28.
go back to reference Ye J, Cheung A, Lichtenstein SV, Nietlispach F, Albugami S, Masson JB, Thompson CR, Munt B, Moss R, Carere RG, Jamieson WR, Webb JG (2010) Transapical transcatheter aortic valve implantation: follow-up to 3 years. J Thorac Cardiovasc Surg 139 (5):1107–1113, 1113 e1101 Ye J, Cheung A, Lichtenstein SV, Nietlispach F, Albugami S, Masson JB, Thompson CR, Munt B, Moss R, Carere RG, Jamieson WR, Webb JG (2010) Transapical transcatheter aortic valve implantation: follow-up to 3 years. J Thorac Cardiovasc Surg 139 (5):1107–1113, 1113 e1101
29.
go back to reference Leontyev S, Walther T, Borger MA, Lehmann S, Funkat AK, Rastan A, Kempfert J, Falk V, Mohr FW (2009) Aortic valve replacement in octogenarians: utility of risk stratification with EuroSCORE. Ann Thorac Surg 87(5):1440–1445PubMedCrossRef Leontyev S, Walther T, Borger MA, Lehmann S, Funkat AK, Rastan A, Kempfert J, Falk V, Mohr FW (2009) Aortic valve replacement in octogenarians: utility of risk stratification with EuroSCORE. Ann Thorac Surg 87(5):1440–1445PubMedCrossRef
30.
go back to reference Thomas M (2010) The global experience with percutaneous aortic valve replacement. JACC Cardiovasc Interv 3(11):1103–1109PubMedCrossRef Thomas M (2010) The global experience with percutaneous aortic valve replacement. JACC Cardiovasc Interv 3(11):1103–1109PubMedCrossRef
31.
go back to reference Kolh P, Kerzmann A, Honore C, Comte L, Limet R (2007) Aortic valve surgery in octogenarians: predictive factors for operative and long-term results. Eur J Cardiothorac Surg 31(4):600–606PubMedCrossRef Kolh P, Kerzmann A, Honore C, Comte L, Limet R (2007) Aortic valve surgery in octogenarians: predictive factors for operative and long-term results. Eur J Cardiothorac Surg 31(4):600–606PubMedCrossRef
32.
go back to reference Ussia GP, Mule M, Barbanti M, Cammalleri V, Scarabelli M, Imme S, Capodanno D, Ciriminna S, Tamburino C (2009) Quality of life assessment after percutaneous aortic valve implantation. Eur Heart J 30(14):1790–1796PubMedCrossRef Ussia GP, Mule M, Barbanti M, Cammalleri V, Scarabelli M, Imme S, Capodanno D, Ciriminna S, Tamburino C (2009) Quality of life assessment after percutaneous aortic valve implantation. Eur Heart J 30(14):1790–1796PubMedCrossRef
Metadata
Title
Clinical trial experience with transcatheter aortic valve insertion
Authors
Thomas J. Helton
Samir R. Kapadia
E. Murat Tuzcu
Publication date
01-12-2011
Publisher
Springer Netherlands
Published in
The International Journal of Cardiovascular Imaging / Issue 8/2011
Print ISSN: 1569-5794
Electronic ISSN: 1875-8312
DOI
https://doi.org/10.1007/s10554-011-9825-2

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