5-Year Outcomes Comparing Surgical Versus Transcatheter Aortic Valve Replacement in Patients With Chronic Kidney Disease

Santiago Garcia; Robert J. Cubeddu; Rebecca T. Hahn; Julien Ternacle; Samir R. Kapadia; Susheel K. Kodali; Vinod H. Thourani; Wael A. Jaber; Craig R. Asher; Sammy Elmariah; Raj Makkar; John G. Webb; Howard C. Herrmann; Michael Lu; Chandan M. Devireddy; S. Chris Malaisrie; Craig R. Smith; Michael J. Mack; Paul Sorajja; João L. Cavalcante; Mario Goessl; Gautam R. Shroff; Martin B. Leon; Philippe Pibarot

doi:10.1016/j.jcin.2021.07.004

5-Year Outcomes Comparing Surgical Versus Transcatheter Aortic Valve Replacement in Patients With Chronic Kidney Disease

Santiago Garcia^*, Robert J. Cubeddu, Rebecca T. Hahn, Julien Ternacle, Samir R. Kapadia, Susheel K. Kodali, Vinod H. Thourani, Wael A. Jaber, Craig R. Asher, Sammy Elmariah, Raj Makkar, John G. Webb, Howard C. Herrmann, Michael Lu, Chandan M. Devireddy, S. Chris Malaisrie, Craig R. Smith, Michael J. Mack, Paul Sorajja, João L. CavalcanteMario Goessl, Gautam R. Shroff, Martin B. Leon, Philippe Pibarot

^*Corresponding author for this work

Surgery, Cardiac Surgery Division

Research output: Contribution to journal › Article › peer-review

22 Scopus citations

Abstract

Objectives: The aim of this study was to compare 5-year cardiovascular, renal, and bioprosthetic valve durability outcomes in patients with severe aortic stenosis (AS) and chronic kidney disease (CKD) undergoing transcatheter aortic valve replacement (TAVR) or surgical aortic valve replacement (SAVR). Background: Patients with severe AS and CKD undergoing TAVR or SAVR are a challenging, understudied clinical subset. Methods: Intermediate-risk patients with moderate to severe CKD (estimated glomerular filtration rate <60 mL/min/m²) from the PARTNER (Placement of Aortic Transcatheter Valve) 2A trial (patients randomly assigned to SAPIEN XT TAVR or SAVR) and SAPIEN 3 Intermediate Risk Registry were pooled. The composite primary outcome of death, stroke, rehospitalization, and new hemodialysis was evaluated using Cox regression analysis. Patients with and without perioperative acute kidney injury (AKI) were followed through 5 years. A core laboratory–adjudicated analysis of structural valve deterioration and bioprosthetic valve failure was also performed. Results: The study population included 1,045 TAVR patients (512 SAPIEN XT, 533 SAPIEN 3) and 479 SAVR patients. At 5 years, SAVR was better than SAPIEN XT TAVR (52.8% vs 68.0%; P = 0.04) but similar to SAPIEN 3 TAVR (52.8% vs 58.7%; P = 0.89). Perioperative AKI was more common after SAVR than TAVR (26.3% vs 10.3%; P < 0.001) and was independently associated with long-term outcomes. Compared with SAVR, bioprosthetic valve failure and stage 2 or 3 structural valve deterioration were significantly greater for SAPIEN XT TAVR (P < 0.05) but not for SAPIEN 3 TAVR. Conclusions: In intermediate-risk patients with AS and CKD, SAPIEN 3 TAVR and SAVR were associated with a similar risk for the primary endpoint at 5 years. AKI was more common after SAVR than TAVR, and SAPIEN 3 valve durability was comparable with that of surgical bioprostheses.

Original language	English (US)
Pages (from-to)	1995-2005
Number of pages	11
Journal	JACC: Cardiovascular Interventions
Volume	14
Issue number	18
DOIs	https://doi.org/10.1016/j.jcin.2021.07.004
State	Published - Sep 27 2021

Funding

The authors thank Erin Rogers and Marissa Gunnarsson, Scientific Publications Office, Edwards Lifesciences. Edwards Lifesciences funded the PARTNER 2A trial and the SAPIEN 3 Intermediate Risk Registry. Dr Garcia has received institutional research grants from Edwards Lifesciences, Abbott Vascular, BSCI, and Biotronik; is a consultant for NeoChord, Medtronic, BSCI, and Abbott Vascular; and is a proctor for Edwards Lifesciences. Dr Cubeddu is an educational speaker and has conducted proctor-related activities for Edwards Lifesciences and Abbott Vascular. Dr Hahn has received speaker fees from Edwards Lifesciences and Philips Healthcare; has received consulting fees from Abbott Structural, Boston Scientific, Edwards Lifesciences, Gore & Associates, and Medtronic; holds equity with Navigate; and is chief scientific officer for the echocardiography core laboratory at the Cardiovascular Research Foundation for multiple industry-sponsored trials, for which she receives no direct industry compensation. Dr Kapadia has received institutional research grants from Edwards Lifesciences (no direct physician compensation). Dr Kodali is a consultant (honoraria) for Admedus and Dura Biotech; is a scientific advisory board member (equity) for Dura Biotech, MicroInterventional Devices, Thubrikar Aortic Valve, Supira, Admedus, TriFlo, and Adona; and has received institutional research funding from Edwards Lifesciences, Medtronic, Abbott Vascular, Boston Scientific, JenaValve, and Keystone Medical. Dr Thourani is a consultant for Abbott Vascular, Boston Scientific, Cryolife, Edwards Lifesciences, JenaValve, Shockwave, and W.L. Gore. Dr Jaber receives monetary institutional support for echocardiography core laboratory in TAVR, with no direct or indirect personal compensation. Dr Elmariah has received institutional research grants from Edwards Lifesciences, Medtronic, and Abbott Vascular; and is a consultant for Edwards Lifesciences. Dr Makkar has received grants from Edwards Lifesciences and Abbott; and has served as a consultant for Cordis and Medtronic. Dr Webb has served as a proctor and consultant for Edwards Lifesciences. Dr Herrmann has received institutional research grants from Abbott Vascular, Boston Scientific, Edwards Lifesciences, and Medtronic; and has received consulting and speaker honoraria from Edwards Lifesciences and Medtronic. Dr Lu is an employee of Edwards Lifesciences. Dr Devireddy has received consulting fees from Edwards Lifesciences, Medtronic, ReCor Medical, and Shockwave Medical. Dr Malaisrie has received consulting fees Edwards Lifesciences, Medtronic, and Cryolife. Dr Smith has been reimbursed for travel and other customary expenses related to trial management as a principal investigator of the PARTNER trials. Dr Mack has received consulting fees from Gore; has served as a trial coprimary investigator for Edwards Lifesciences and Abbott; and has served as a study chair for Medtronic. Dr Sorajja has received institutional research grants from Edwards Lifesciences, Abbott Vascular, Boston Scientific, and Medtronic; and is a consultant for Abbott Vascular, Boston Scientific, Medtronic, NeoVasc, TeleFlex, TriFlo, VDyne, and W.L. Gore. Dr Cavalcante has received research grants from and is a consultant for Abbott Vascular, Circle Cardiovascular Imaging, Boston Scientific, Medtronic, Siemens Healthineers, and Edwards Lifesciences; is a consultant for VDyne and Triflo; and is a member of the Speakers Bureau for Circle Cardiovascular Imaging, Medtronic, Siemens Healthineers. Dr Goessl is a consultant for Abbott Vascular. Dr Leon has received institutional research support from Edwards Lifesciences, Medtronic, Boston Scientific, and Abbott. Dr Pibarot has received research grants from Edwards Lifesciences and Medtronic for echocardiography core laboratory or in vitro analyses in TAVR, with no personal compensation. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.

Keywords

acute kidney injury
bioprosthetic valve failure
hemodialysis
intermediate risk
structural valve deterioration

ASJC Scopus subject areas

Cardiology and Cardiovascular Medicine

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

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10.1016/j.jcin.2021.07.004

Cite this

Garcia, S., Cubeddu, R. J., Hahn, R. T., Ternacle, J., Kapadia, S. R., Kodali, S. K., Thourani, V. H., Jaber, W. A., Asher, C. R., Elmariah, S., Makkar, R., Webb, J. G., Herrmann, H. C., Lu, M., Devireddy, C. M., Malaisrie, S. C., Smith, C. R., Mack, M. J., Sorajja, P., ... Pibarot, P. (2021). 5-Year Outcomes Comparing Surgical Versus Transcatheter Aortic Valve Replacement in Patients With Chronic Kidney Disease. JACC: Cardiovascular Interventions, 14(18), 1995-2005. https://doi.org/10.1016/j.jcin.2021.07.004

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title = "5-Year Outcomes Comparing Surgical Versus Transcatheter Aortic Valve Replacement in Patients With Chronic Kidney Disease",

abstract = "Objectives: The aim of this study was to compare 5-year cardiovascular, renal, and bioprosthetic valve durability outcomes in patients with severe aortic stenosis (AS) and chronic kidney disease (CKD) undergoing transcatheter aortic valve replacement (TAVR) or surgical aortic valve replacement (SAVR). Background: Patients with severe AS and CKD undergoing TAVR or SAVR are a challenging, understudied clinical subset. Methods: Intermediate-risk patients with moderate to severe CKD (estimated glomerular filtration rate <60 mL/min/m2) from the PARTNER (Placement of Aortic Transcatheter Valve) 2A trial (patients randomly assigned to SAPIEN XT TAVR or SAVR) and SAPIEN 3 Intermediate Risk Registry were pooled. The composite primary outcome of death, stroke, rehospitalization, and new hemodialysis was evaluated using Cox regression analysis. Patients with and without perioperative acute kidney injury (AKI) were followed through 5 years. A core laboratory–adjudicated analysis of structural valve deterioration and bioprosthetic valve failure was also performed. Results: The study population included 1,045 TAVR patients (512 SAPIEN XT, 533 SAPIEN 3) and 479 SAVR patients. At 5 years, SAVR was better than SAPIEN XT TAVR (52.8% vs 68.0%; P = 0.04) but similar to SAPIEN 3 TAVR (52.8% vs 58.7%; P = 0.89). Perioperative AKI was more common after SAVR than TAVR (26.3% vs 10.3%; P < 0.001) and was independently associated with long-term outcomes. Compared with SAVR, bioprosthetic valve failure and stage 2 or 3 structural valve deterioration were significantly greater for SAPIEN XT TAVR (P < 0.05) but not for SAPIEN 3 TAVR. Conclusions: In intermediate-risk patients with AS and CKD, SAPIEN 3 TAVR and SAVR were associated with a similar risk for the primary endpoint at 5 years. AKI was more common after SAVR than TAVR, and SAPIEN 3 valve durability was comparable with that of surgical bioprostheses.",

keywords = "acute kidney injury, bioprosthetic valve failure, hemodialysis, intermediate risk, structural valve deterioration",

author = "Santiago Garcia and Cubeddu, {Robert J.} and Hahn, {Rebecca T.} and Julien Ternacle and Kapadia, {Samir R.} and Kodali, {Susheel K.} and Thourani, {Vinod H.} and Jaber, {Wael A.} and Asher, {Craig R.} and Sammy Elmariah and Raj Makkar and Webb, {John G.} and Herrmann, {Howard C.} and Michael Lu and Devireddy, {Chandan M.} and Malaisrie, {S. Chris} and Smith, {Craig R.} and Mack, {Michael J.} and Paul Sorajja and Cavalcante, {Jo{\~a}o L.} and Mario Goessl and Shroff, {Gautam R.} and Leon, {Martin B.} and Philippe Pibarot",

note = "Publisher Copyright: {\textcopyright} 2021 American College of Cardiology Foundation",

year = "2021",

month = sep,

day = "27",

doi = "10.1016/j.jcin.2021.07.004",

language = "English (US)",

volume = "14",

pages = "1995--2005",

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Garcia, S, Cubeddu, RJ, Hahn, RT, Ternacle, J, Kapadia, SR, Kodali, SK, Thourani, VH, Jaber, WA, Asher, CR, Elmariah, S, Makkar, R, Webb, JG, Herrmann, HC, Lu, M, Devireddy, CM, Malaisrie, SC, Smith, CR, Mack, MJ, Sorajja, P, Cavalcante, JL, Goessl, M, Shroff, GR, Leon, MB & Pibarot, P 2021, '5-Year Outcomes Comparing Surgical Versus Transcatheter Aortic Valve Replacement in Patients With Chronic Kidney Disease', JACC: Cardiovascular Interventions, vol. 14, no. 18, pp. 1995-2005. https://doi.org/10.1016/j.jcin.2021.07.004

TY - JOUR

T1 - 5-Year Outcomes Comparing Surgical Versus Transcatheter Aortic Valve Replacement in Patients With Chronic Kidney Disease

AU - Garcia, Santiago

AU - Cubeddu, Robert J.

AU - Hahn, Rebecca T.

AU - Ternacle, Julien

AU - Kapadia, Samir R.

AU - Kodali, Susheel K.

AU - Thourani, Vinod H.

AU - Jaber, Wael A.

AU - Asher, Craig R.

AU - Elmariah, Sammy

AU - Makkar, Raj

AU - Webb, John G.

AU - Herrmann, Howard C.

AU - Lu, Michael

AU - Devireddy, Chandan M.

AU - Malaisrie, S. Chris

AU - Smith, Craig R.

AU - Mack, Michael J.

AU - Sorajja, Paul

AU - Cavalcante, João L.

AU - Goessl, Mario

AU - Shroff, Gautam R.

AU - Leon, Martin B.

AU - Pibarot, Philippe

PY - 2021/9/27

Y1 - 2021/9/27

N2 - Objectives: The aim of this study was to compare 5-year cardiovascular, renal, and bioprosthetic valve durability outcomes in patients with severe aortic stenosis (AS) and chronic kidney disease (CKD) undergoing transcatheter aortic valve replacement (TAVR) or surgical aortic valve replacement (SAVR). Background: Patients with severe AS and CKD undergoing TAVR or SAVR are a challenging, understudied clinical subset. Methods: Intermediate-risk patients with moderate to severe CKD (estimated glomerular filtration rate <60 mL/min/m2) from the PARTNER (Placement of Aortic Transcatheter Valve) 2A trial (patients randomly assigned to SAPIEN XT TAVR or SAVR) and SAPIEN 3 Intermediate Risk Registry were pooled. The composite primary outcome of death, stroke, rehospitalization, and new hemodialysis was evaluated using Cox regression analysis. Patients with and without perioperative acute kidney injury (AKI) were followed through 5 years. A core laboratory–adjudicated analysis of structural valve deterioration and bioprosthetic valve failure was also performed. Results: The study population included 1,045 TAVR patients (512 SAPIEN XT, 533 SAPIEN 3) and 479 SAVR patients. At 5 years, SAVR was better than SAPIEN XT TAVR (52.8% vs 68.0%; P = 0.04) but similar to SAPIEN 3 TAVR (52.8% vs 58.7%; P = 0.89). Perioperative AKI was more common after SAVR than TAVR (26.3% vs 10.3%; P < 0.001) and was independently associated with long-term outcomes. Compared with SAVR, bioprosthetic valve failure and stage 2 or 3 structural valve deterioration were significantly greater for SAPIEN XT TAVR (P < 0.05) but not for SAPIEN 3 TAVR. Conclusions: In intermediate-risk patients with AS and CKD, SAPIEN 3 TAVR and SAVR were associated with a similar risk for the primary endpoint at 5 years. AKI was more common after SAVR than TAVR, and SAPIEN 3 valve durability was comparable with that of surgical bioprostheses.

AB - Objectives: The aim of this study was to compare 5-year cardiovascular, renal, and bioprosthetic valve durability outcomes in patients with severe aortic stenosis (AS) and chronic kidney disease (CKD) undergoing transcatheter aortic valve replacement (TAVR) or surgical aortic valve replacement (SAVR). Background: Patients with severe AS and CKD undergoing TAVR or SAVR are a challenging, understudied clinical subset. Methods: Intermediate-risk patients with moderate to severe CKD (estimated glomerular filtration rate <60 mL/min/m2) from the PARTNER (Placement of Aortic Transcatheter Valve) 2A trial (patients randomly assigned to SAPIEN XT TAVR or SAVR) and SAPIEN 3 Intermediate Risk Registry were pooled. The composite primary outcome of death, stroke, rehospitalization, and new hemodialysis was evaluated using Cox regression analysis. Patients with and without perioperative acute kidney injury (AKI) were followed through 5 years. A core laboratory–adjudicated analysis of structural valve deterioration and bioprosthetic valve failure was also performed. Results: The study population included 1,045 TAVR patients (512 SAPIEN XT, 533 SAPIEN 3) and 479 SAVR patients. At 5 years, SAVR was better than SAPIEN XT TAVR (52.8% vs 68.0%; P = 0.04) but similar to SAPIEN 3 TAVR (52.8% vs 58.7%; P = 0.89). Perioperative AKI was more common after SAVR than TAVR (26.3% vs 10.3%; P < 0.001) and was independently associated with long-term outcomes. Compared with SAVR, bioprosthetic valve failure and stage 2 or 3 structural valve deterioration were significantly greater for SAPIEN XT TAVR (P < 0.05) but not for SAPIEN 3 TAVR. Conclusions: In intermediate-risk patients with AS and CKD, SAPIEN 3 TAVR and SAVR were associated with a similar risk for the primary endpoint at 5 years. AKI was more common after SAVR than TAVR, and SAPIEN 3 valve durability was comparable with that of surgical bioprostheses.

KW - acute kidney injury

KW - bioprosthetic valve failure

KW - hemodialysis

KW - intermediate risk

KW - structural valve deterioration

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5-Year Outcomes Comparing Surgical Versus Transcatheter Aortic Valve Replacement in Patients With Chronic Kidney Disease

Abstract

Funding

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UN SDGs

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