The PARTNER 3 Bicuspid Registry for Transcatheter Aortic Valve Replacement in Low-Surgical-Risk Patients

Mathew R. Williams; Hasan Jilaihawi; Raj Makkar; William W. O'Neill; Robert Guyton; S. Chris Malaisrie; David L. Brown; Philipp Blanke; Jonathon A. Leipsic; Philippe Pibarot; Rebecca T. Hahn; Martin B. Leon; David J. Cohen; Jeroen J. Bax; Susheel K. Kodali; Michael J. Mack; Michael Lu; John G. Webb

doi:10.1016/j.jcin.2022.01.279

The PARTNER 3 Bicuspid Registry for Transcatheter Aortic Valve Replacement in Low-Surgical-Risk Patients

Mathew R. Williams^*, Hasan Jilaihawi, Raj Makkar, William W. O'Neill, Robert Guyton, S. Chris Malaisrie, David L. Brown, Philipp Blanke, Jonathon A. Leipsic, Philippe Pibarot, Rebecca T. Hahn, Martin B. Leon, David J. Cohen, Jeroen J. Bax, Susheel K. Kodali, Michael J. Mack, Michael Lu, John G. Webb

^*Corresponding author for this work

Surgery, Cardiac Surgery Division

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

34 Scopus citations

Abstract

Objectives: The study compared 1-year outcomes between transcatheter aortic valve replacement (TAVR) patients with bicuspid aortic valve (BAV) morphology and clinically similar patients having tricuspid aortic valve (TAV) morphology. Background: There are limited prospective data on TAVR using the SAPIEN 3 device in low-surgical-risk patients with severe, symptomatic aortic stenosis and bicuspid anatomy. Methods: Low-risk, severe aortic stenosis patients with BAV were candidates for the PARTNER 3 (Placement of Aortic Transcatheter Valves 3) (P3) bicuspid registry or the P3 bicuspid continued access protocol. Patients treated in these registries were pooled and propensity score matched to TAV patients from the P3 randomized TAVR trial. Outcomes were compared between groups. The primary endpoint was the 1-year composite rate of death, stroke, and cardiovascular rehospitalization. Results: Of 320 total submitted BAV patients, 169 (53%) were treated, and most were Sievers type 1. The remaining 151 patients were excluded caused by anatomic or clinical criteria. Propensity score matching with the P3 TAVR cohort (496 patients) yielded 148 pairs. There were no differences in baseline clinical characteristics; however, BAV patients had larger annuli and they experienced longer procedure duration. There was no difference in the primary endpoint between BAV and TAV (10.9% vs 10.2%; P = 0.80) or in the rates of the individual components (death: 0.7% vs 1.4%; P = 0.58; stroke: 2.1% vs 2.0%; P = 0.99; cardiovascular rehospitalization: 9.6% vs 9.5%; P = 0.96). Conclusions: Among highly select bicuspid aortic stenosis low-surgical-risk patients without extensive raphe or subannular calcification, TAVR with the SAPIEN 3 valve demonstrated similar outcomes to a matched cohort of patients with tricuspid aortic stenosis.

Original language	English (US)
Pages (from-to)	523-532
Number of pages	10
Journal	JACC: Cardiovascular Interventions
Volume	15
Issue number	5
DOIs	https://doi.org/10.1016/j.jcin.2022.01.279
State	Published - Mar 14 2022

Funding

The PARTNER 3 trial was funded by Edwards Lifesciences. Dr Williams has served as a consultant to Medtronic; and has received research funding from Edwards Lifesciences and Medtronic. Dr Jilaihawi has served as a consultant to Boston Scientific and Medtronic plc; and has received research funding from Abbott Vascular, Edwards Lifesciences, Medtronic plc, and HLT. Dr Makkar has received grant support from Abbott, Medtronic plc, Boston Scientific, and Edwards Lifesciences. Dr O’Neill has served as a consultant for Abiomed, Edwards Lifesciences, Medtronic plc, Boston Scientific, Abbott Vascular, and St. Jude Medical; and has served on the Board of Directors of Neovasc. Dr Guyton has served as a consultant for Edwards Lifesciences. Dr Malaisrie has received consulting fees from Medtronic plc and Edwards Lifesciences; and has received lecture fees from Abbott, CryoLife, and Terumo Aortic. Dr Brown has reported that he has no relationships relevant to the contents of this paper to disclose. Dr Blanke has received consulting fees from Edwards Lifesciences, Tendyne (Abbott), Circle Cardiovascular Imaging, Neovasc, and Gore. Dr Leipsic has received core laboratory grant support, paid to his institution, from Edwards Lifesciences, Medtronic plc, Boston Scientific, Abbott, MVRX, and PI Cardia; and has received consulting fees Circle Cardiovascular Imaging, MVRX, and HeartFlow. Dr Pibarot has received core laboratory grant support, paid to his institution, from Edwards Lifesciences, Pi-Cardia, and Medtronic plc. Dr Hahn has received speaker fees from Abbott Structural, Edwards Lifesciences, and Philips Healthcare; has received consulting fees from Abbott Structural, Boston Scientific, Edwards Lifesciences, and Gore and Associates; owns equity in Navigate; and is Chief Scientific Officer for the Echocardiography Core Laboratory at the Cardiovascular Research Foundation for multiple industry-sponsored trials, for which she has received no direct industry compensation. Dr Leon has received grant support, paid to his institution, from Edwards Lifesciences, Medtronic, Abbott, and Boston Scientific; and has received advisory fees from Medtronic, Abbott, Boston Scientific, Gore, and Meril Life Sciences. Dr Cohen has received grant support, paid to his institution, from Edwards Lifesciences, Medtronic plc, Boston Scientific, and Abbott Vascular; and has received consulting fees from Edwards Lifesciences, Medtronic plc, Boston Scientific, and Abbott Vascular. Dr Bax has received grant support, paid to his institution, from Biotronik, Medtronic, Boston Scientific, GE Healthcare, Bayer, and Edwards Lifesciences; and has received speaker fees from Abbott Vascular and Edwards Lifesciences. Dr Kodali holds equity in Dura Biotech, MicroInterventional Devices, Thubrikar Aortic Valve Inc, Supira, Admedus, TriFlo, and Adona; has received consulting fees from Admedus and Dura Biotech; and has received institutional funding from Edwards Lifesciences, Medtronic, Abbott Vascular, Boston Scientific, and JenaValve. Dr Mack has received consulting fees from Gore; has served as a trial coprimary investigator for Edwards Lifesciences and Abbott; and served as a study chair for Medtronic. Dr Lu is an employee of Edwards Lifesciences. Dr Webb has received consulting fees and fees for serving as a proctor from Edwards Lifesciences.

Keywords

TAVR
aortic stenosis
bicuspid
transcatheter aortic valve replacement

ASJC Scopus subject areas

Cardiology and Cardiovascular Medicine

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10.1016/j.jcin.2022.01.279

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Williams, M. R., Jilaihawi, H., Makkar, R., O'Neill, W. W., Guyton, R., Malaisrie, S. C., Brown, D. L., Blanke, P., Leipsic, J. A., Pibarot, P., Hahn, R. T., Leon, M. B., Cohen, D. J., Bax, J. J., Kodali, S. K., Mack, M. J., Lu, M., & Webb, J. G. (2022). The PARTNER 3 Bicuspid Registry for Transcatheter Aortic Valve Replacement in Low-Surgical-Risk Patients. JACC: Cardiovascular Interventions, 15(5), 523-532. https://doi.org/10.1016/j.jcin.2022.01.279

@article{55eca7cb143940afbff7c8852f93778f,

title = "The PARTNER 3 Bicuspid Registry for Transcatheter Aortic Valve Replacement in Low-Surgical-Risk Patients",

abstract = "Objectives: The study compared 1-year outcomes between transcatheter aortic valve replacement (TAVR) patients with bicuspid aortic valve (BAV) morphology and clinically similar patients having tricuspid aortic valve (TAV) morphology. Background: There are limited prospective data on TAVR using the SAPIEN 3 device in low-surgical-risk patients with severe, symptomatic aortic stenosis and bicuspid anatomy. Methods: Low-risk, severe aortic stenosis patients with BAV were candidates for the PARTNER 3 (Placement of Aortic Transcatheter Valves 3) (P3) bicuspid registry or the P3 bicuspid continued access protocol. Patients treated in these registries were pooled and propensity score matched to TAV patients from the P3 randomized TAVR trial. Outcomes were compared between groups. The primary endpoint was the 1-year composite rate of death, stroke, and cardiovascular rehospitalization. Results: Of 320 total submitted BAV patients, 169 (53%) were treated, and most were Sievers type 1. The remaining 151 patients were excluded caused by anatomic or clinical criteria. Propensity score matching with the P3 TAVR cohort (496 patients) yielded 148 pairs. There were no differences in baseline clinical characteristics; however, BAV patients had larger annuli and they experienced longer procedure duration. There was no difference in the primary endpoint between BAV and TAV (10.9% vs 10.2%; P = 0.80) or in the rates of the individual components (death: 0.7% vs 1.4%; P = 0.58; stroke: 2.1% vs 2.0%; P = 0.99; cardiovascular rehospitalization: 9.6% vs 9.5%; P = 0.96). Conclusions: Among highly select bicuspid aortic stenosis low-surgical-risk patients without extensive raphe or subannular calcification, TAVR with the SAPIEN 3 valve demonstrated similar outcomes to a matched cohort of patients with tricuspid aortic stenosis.",

keywords = "TAVR, aortic stenosis, bicuspid, transcatheter aortic valve replacement",

author = "Williams, {Mathew R.} and Hasan Jilaihawi and Raj Makkar and O'Neill, {William W.} and Robert Guyton and Malaisrie, {S. Chris} and Brown, {David L.} and Philipp Blanke and Leipsic, {Jonathon A.} and Philippe Pibarot and Hahn, {Rebecca T.} and Leon, {Martin B.} and Cohen, {David J.} and Bax, {Jeroen J.} and Kodali, {Susheel K.} and Mack, {Michael J.} and Michael Lu and Webb, {John G.}",

note = "Publisher Copyright: {\textcopyright} 2022 American College of Cardiology Foundation",

year = "2022",

month = mar,

day = "14",

doi = "10.1016/j.jcin.2022.01.279",

language = "English (US)",

volume = "15",

pages = "523--532",

journal = "JACC: Cardiovascular Interventions",

issn = "1936-8798",

publisher = "Elsevier Inc.",

number = "5",

}

Williams, MR, Jilaihawi, H, Makkar, R, O'Neill, WW, Guyton, R, Malaisrie, SC, Brown, DL, Blanke, P, Leipsic, JA, Pibarot, P, Hahn, RT, Leon, MB, Cohen, DJ, Bax, JJ, Kodali, SK, Mack, MJ, Lu, M & Webb, JG 2022, 'The PARTNER 3 Bicuspid Registry for Transcatheter Aortic Valve Replacement in Low-Surgical-Risk Patients', JACC: Cardiovascular Interventions, vol. 15, no. 5, pp. 523-532. https://doi.org/10.1016/j.jcin.2022.01.279

TY - JOUR

T1 - The PARTNER 3 Bicuspid Registry for Transcatheter Aortic Valve Replacement in Low-Surgical-Risk Patients

AU - Williams, Mathew R.

AU - Jilaihawi, Hasan

AU - Makkar, Raj

AU - O'Neill, William W.

AU - Guyton, Robert

AU - Malaisrie, S. Chris

AU - Brown, David L.

AU - Blanke, Philipp

AU - Leipsic, Jonathon A.

AU - Pibarot, Philippe

AU - Hahn, Rebecca T.

AU - Leon, Martin B.

AU - Cohen, David J.

AU - Bax, Jeroen J.

AU - Kodali, Susheel K.

AU - Mack, Michael J.

AU - Lu, Michael

AU - Webb, John G.

PY - 2022/3/14

Y1 - 2022/3/14

N2 - Objectives: The study compared 1-year outcomes between transcatheter aortic valve replacement (TAVR) patients with bicuspid aortic valve (BAV) morphology and clinically similar patients having tricuspid aortic valve (TAV) morphology. Background: There are limited prospective data on TAVR using the SAPIEN 3 device in low-surgical-risk patients with severe, symptomatic aortic stenosis and bicuspid anatomy. Methods: Low-risk, severe aortic stenosis patients with BAV were candidates for the PARTNER 3 (Placement of Aortic Transcatheter Valves 3) (P3) bicuspid registry or the P3 bicuspid continued access protocol. Patients treated in these registries were pooled and propensity score matched to TAV patients from the P3 randomized TAVR trial. Outcomes were compared between groups. The primary endpoint was the 1-year composite rate of death, stroke, and cardiovascular rehospitalization. Results: Of 320 total submitted BAV patients, 169 (53%) were treated, and most were Sievers type 1. The remaining 151 patients were excluded caused by anatomic or clinical criteria. Propensity score matching with the P3 TAVR cohort (496 patients) yielded 148 pairs. There were no differences in baseline clinical characteristics; however, BAV patients had larger annuli and they experienced longer procedure duration. There was no difference in the primary endpoint between BAV and TAV (10.9% vs 10.2%; P = 0.80) or in the rates of the individual components (death: 0.7% vs 1.4%; P = 0.58; stroke: 2.1% vs 2.0%; P = 0.99; cardiovascular rehospitalization: 9.6% vs 9.5%; P = 0.96). Conclusions: Among highly select bicuspid aortic stenosis low-surgical-risk patients without extensive raphe or subannular calcification, TAVR with the SAPIEN 3 valve demonstrated similar outcomes to a matched cohort of patients with tricuspid aortic stenosis.

AB - Objectives: The study compared 1-year outcomes between transcatheter aortic valve replacement (TAVR) patients with bicuspid aortic valve (BAV) morphology and clinically similar patients having tricuspid aortic valve (TAV) morphology. Background: There are limited prospective data on TAVR using the SAPIEN 3 device in low-surgical-risk patients with severe, symptomatic aortic stenosis and bicuspid anatomy. Methods: Low-risk, severe aortic stenosis patients with BAV were candidates for the PARTNER 3 (Placement of Aortic Transcatheter Valves 3) (P3) bicuspid registry or the P3 bicuspid continued access protocol. Patients treated in these registries were pooled and propensity score matched to TAV patients from the P3 randomized TAVR trial. Outcomes were compared between groups. The primary endpoint was the 1-year composite rate of death, stroke, and cardiovascular rehospitalization. Results: Of 320 total submitted BAV patients, 169 (53%) were treated, and most were Sievers type 1. The remaining 151 patients were excluded caused by anatomic or clinical criteria. Propensity score matching with the P3 TAVR cohort (496 patients) yielded 148 pairs. There were no differences in baseline clinical characteristics; however, BAV patients had larger annuli and they experienced longer procedure duration. There was no difference in the primary endpoint between BAV and TAV (10.9% vs 10.2%; P = 0.80) or in the rates of the individual components (death: 0.7% vs 1.4%; P = 0.58; stroke: 2.1% vs 2.0%; P = 0.99; cardiovascular rehospitalization: 9.6% vs 9.5%; P = 0.96). Conclusions: Among highly select bicuspid aortic stenosis low-surgical-risk patients without extensive raphe or subannular calcification, TAVR with the SAPIEN 3 valve demonstrated similar outcomes to a matched cohort of patients with tricuspid aortic stenosis.

KW - TAVR

KW - aortic stenosis

KW - bicuspid

KW - transcatheter aortic valve replacement

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DO - 10.1016/j.jcin.2022.01.279

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AN - SCOPUS:85125297803

SN - 1936-8798

VL - 15

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JO - JACC: Cardiovascular Interventions

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ER -

The PARTNER 3 Bicuspid Registry for Transcatheter Aortic Valve Replacement in Low-Surgical-Risk Patients

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