Echocardiographic Results of Transcatheter Versus Surgical Aortic Valve Replacement in Low-Risk Patients: The PARTNER 3 Trial

Philippe Pibarot; Erwan Salaun; Abdellaziz Dahou; Eleonora Avenatti; Ezequiel Guzzetti; Mohamed Salah Annabi; Oumhani Toubal; Mathieu Bernier; Jonathan Beaudoin; Géraldine Ong; Julien Ternacle; Laura Krapf; Vinod H. Thourani; Raj Makkar; Susheel K. Kodali; Mark Russo; Samir R. Kapadia; S. Chris Malaisrie; David J. Cohen; Jonathon Leipsic; Philipp Blanke; Mathew R. Williams; James M. McCabe; David L. Brown; Vasilis Babaliaros; Scott Goldman; Wilson Y. Szeto; Philippe Généreux; Ashish Pershad; Maria C. Alu; Ke Xu; Erin Rogers; John G. Webb; Craig R. Smith; Michael J. Mack; Martin B. Leon; Rebecca T. Hahn

doi:10.1161/CIRCULATIONAHA.119.044574

Echocardiographic Results of Transcatheter Versus Surgical Aortic Valve Replacement in Low-Risk Patients: The PARTNER 3 Trial

Philippe Pibarot^*, Erwan Salaun, Abdellaziz Dahou, Eleonora Avenatti, Ezequiel Guzzetti, Mohamed Salah Annabi, Oumhani Toubal, Mathieu Bernier, Jonathan Beaudoin, Géraldine Ong, Julien Ternacle, Laura Krapf, Vinod H. Thourani, Raj Makkar, Susheel K. Kodali, Mark Russo, Samir R. Kapadia, S. Chris Malaisrie, David J. Cohen, Jonathon LeipsicPhilipp Blanke, Mathew R. Williams, James M. McCabe, David L. Brown, Vasilis Babaliaros, Scott Goldman, Wilson Y. Szeto, Philippe Généreux, Ashish Pershad, Maria C. Alu, Ke Xu, Erin Rogers, John G. Webb, Craig R. Smith, Michael J. Mack, Martin B. Leon, Rebecca T. Hahn

^*Corresponding author for this work

Surgery, Cardiac Surgery Division

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

111 Scopus citations

Abstract

Background: This study aimed to compare echocardiographic findings in low-risk patients with severe aortic stenosis after surgical aortic valve replacement (SAVR) or transcatheter aortic valve replacement (TAVR). Methods: The PARTNER 3 trial (Placement of Aortic Transcatheter Valves) randomized 1000 patients with severe aortic stenosis and low surgical risk to undergo either transfemoral TAVR with the balloon-expandable SAPIEN 3 valve or SAVR. Transthoracic echocardiograms obtained at baseline and at 30 days and 1 year after the procedure were analyzed by a consortium of 2 echocardiography core laboratories. Results: The percentage of moderate or severe aortic regurgitation (AR) was low and not statistically different between the TAVR and SAVR groups at 30 days (0.8% versus 0.2%; P=0.38). Mild AR was more frequent after TAVR than SAVR at 30 days (28.8% versus 4.2%; P<0.001). At 1 year, mean transvalvular gradient (13.7±5.6 versus 11.6±5.0 mm Hg; P=0.12) and aortic valve area (1.72±0.37 versus 1.76±0.42 cm²; P=0.12) were similar in TAVR and SAVR. The percentage of severe prosthesis-patient mismatch at 30 days was low and similar between TAVR and SAVR (4.6 versus 6.3%; P=0.30). Valvulo-arterial impedance (Z ^va), which reflects total left ventricular hemodynamic burden, was lower with TAVR than SAVR at 1 year (3.7±0.8 versus 3.9±0.9 mm Hg/mL/m²; P<0.001). Tricuspid annulus plane systolic excursion decreased and the percentage of moderate or severe tricuspid regurgitation increased from baseline to 1 year in SAVR but remained unchanged in TAVR. Irrespective of treatment arm, high Z ^vaand low tricuspid annulus plane systolic excursion, but not moderate to severe AR or severe prosthesis-patient mismatch, were associated with increased risk of the composite end point of mortality, stroke, and rehospitalization at 1 year. Conclusions: In patients with severe aortic stenosis and low surgical risk, TAVR with the SAPIEN 3 valve was associated with similar percentage of moderate or severe AR compared with SAVR but higher percentage of mild AR. Transprosthetic gradients, valve areas, percentage of severe prosthesis-patient mismatch, and left ventricular mass regression were similar in TAVR and SAVR. SAVR was associated with significant deterioration of right ventricular systolic function and greater tricuspid regurgitation, which persisted at 1 year. High Z ^vaand low tricuspid annulus plane systolic excursion were associated with worse outcome at 1 year whereas AR and severe prosthesis-patient mismatch were not. Registration: URL: Https://www.clinicaltrials.gov; Unique identifier: NCT02675114.

Original language	English (US)
Pages (from-to)	1527-1537
Number of pages	11
Journal	Circulation
Volume	141
Issue number	19
DOIs	https://doi.org/10.1161/CIRCULATIONAHA.119.044574
State	Published - May 12 2020

Funding

Dr Pibarot received research grants from Edwards Lifesciences and Medtronic for echo core laboratory analyses in transcatheter aortic valve replacement. Dr Thourani performs research and is a consultant for Abbott Vascular, Allergen, Boston Scientific, Cryolife, Edwards Lifesciences, Gore Vascular, and Jena-valve. Dr Makkar reports grants from Edwards Lifesciences and Abbott and is a consultant for Cordis and Medtronic. Dr Kodali reports institutional research grants from Edwards Lifesciences, Medtronic, and Abbott; consulting fees from Abbott, Admedus, and Meril Life Sciences; and equity options from Biotrace Medical and Thubrikar Aortic Valve Inc. Dr Russo reports an institutional research grant from Edwards Lifesciences and is a consultant or proctor, or both, for Edwards Lifesciences, Abbott, and Boston Scientific. Dr Kapadia reports a research grant to his institution from Edwards Lifesciences (with no direct physician compensation). Dr Malaisrie is a consultant for Edwards Lifesciences, Medtronic, and Abbott. Dr Cohen has received consulting income from Edwards Lifesciences and Medtronic and research grants to his institution from Edwards Lifesciences, Medtronic, Boston Scientific, and Abbott. Dr Leipsic received research grants from Edwards Lifesciences and Medtronic for computed tomographic core laboratory analyses in transcatheter aortic valve replacement and is a consultant for Circle Cardiovascular Imaging. Dr Blanke is a consultant to Edwards Lifesciences, Tendyne, Neovasc, and Circle Cardiovascular Imaging. Drs Leipsic and Blanke provide cardiac computed tomography core laboratory services for Edwards Lifesciences, Tendyne, Medtronic, and Aegis, for which they do not receive any direct compensation. Dr Williams reports research funding from Edwards Lifesciences. Dr McCabe reports an institutional research grant and consulting honoraria from Edwards Lifesciences. Dr Brown reports research support to his institution from Edwards Lifesciences. Dr Babaliaros reports institutional research support from Edwards Lifesciences and consulting fees from Edwards and Abbott. Dr Goldman reports medical advisory board participation for Edwards Lifesciences. Dr Szeto reports institutional research support and consulting fees from Edwards Lifesciences. Dr Généreux reports institutional research support from Edwards Lifesciences; and consulting/advisory board participation for Edwards, Abbott, Boston Scientific, Cardiovascular Solution Inc, Medtronic, Cordis, Saranas, Pi-Cardia, and SIG.NUM. Dr Pershad received institutional grants and consulting fees from Edwards Lifesciences and Boston Scientific Inc. Dr Xu and E. Rogers are employees of Edwards Lifesciences. Dr Webb is a proctor and consultant for Edwards Lifesciences. Dr Mack reports institutional research support (with no direct physician compensation) from Edwards Lifesciences and is a consultant for Gore. Dr Leon reports institutional research support from Edwards Lifesciences, Medtronic, Boston Scientific, and Abbott; and consulting/advisory board participation for Medtronic, Boston Scientific, Gore, Meril Life Sciences, and Abbott. Dr Mack and Dr Leon are the national co–principal investigators of the PARTNER 3 trial (with no compensation). Dr Hahn is a speaker for Abbott Vascular, Boston Scientific, Bayliss, Edwards Lifescience, Philips Healthcare, and Siemens Healthineers; consultant/advisory board member for 3Mensio, Abbott Structural, Edwards Lifescience, Gore & Associates, Medtronic, Navigate, Philips Healthcare, and Siemens Healthineers; and 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. The other authors have nothing to disclose.

Keywords

aortic valve stenosis
echocardiography
hemodynamics
transcatheter aortic valve replacement

ASJC Scopus subject areas

Cardiology and Cardiovascular Medicine
Physiology (medical)

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10.1161/CIRCULATIONAHA.119.044574

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Pibarot, P., Salaun, E., Dahou, A., Avenatti, E., Guzzetti, E., Annabi, M. S., Toubal, O., Bernier, M., Beaudoin, J., Ong, G., Ternacle, J., Krapf, L., Thourani, V. H., Makkar, R., Kodali, S. K., Russo, M., Kapadia, S. R., Malaisrie, S. C., Cohen, D. J., ... Hahn, R. T. (2020). Echocardiographic Results of Transcatheter Versus Surgical Aortic Valve Replacement in Low-Risk Patients: The PARTNER 3 Trial. Circulation, 141(19), 1527-1537. https://doi.org/10.1161/CIRCULATIONAHA.119.044574

@article{7ae9623f9482485b9b628d9e85f86b86,

title = "Echocardiographic Results of Transcatheter Versus Surgical Aortic Valve Replacement in Low-Risk Patients: The PARTNER 3 Trial",

abstract = "Background: This study aimed to compare echocardiographic findings in low-risk patients with severe aortic stenosis after surgical aortic valve replacement (SAVR) or transcatheter aortic valve replacement (TAVR). Methods: The PARTNER 3 trial (Placement of Aortic Transcatheter Valves) randomized 1000 patients with severe aortic stenosis and low surgical risk to undergo either transfemoral TAVR with the balloon-expandable SAPIEN 3 valve or SAVR. Transthoracic echocardiograms obtained at baseline and at 30 days and 1 year after the procedure were analyzed by a consortium of 2 echocardiography core laboratories. Results: The percentage of moderate or severe aortic regurgitation (AR) was low and not statistically different between the TAVR and SAVR groups at 30 days (0.8% versus 0.2%; P=0.38). Mild AR was more frequent after TAVR than SAVR at 30 days (28.8% versus 4.2%; P<0.001). At 1 year, mean transvalvular gradient (13.7±5.6 versus 11.6±5.0 mm Hg; P=0.12) and aortic valve area (1.72±0.37 versus 1.76±0.42 cm2; P=0.12) were similar in TAVR and SAVR. The percentage of severe prosthesis-patient mismatch at 30 days was low and similar between TAVR and SAVR (4.6 versus 6.3%; P=0.30). Valvulo-arterial impedance (Z va), which reflects total left ventricular hemodynamic burden, was lower with TAVR than SAVR at 1 year (3.7±0.8 versus 3.9±0.9 mm Hg/mL/m2; P<0.001). Tricuspid annulus plane systolic excursion decreased and the percentage of moderate or severe tricuspid regurgitation increased from baseline to 1 year in SAVR but remained unchanged in TAVR. Irrespective of treatment arm, high Z vaand low tricuspid annulus plane systolic excursion, but not moderate to severe AR or severe prosthesis-patient mismatch, were associated with increased risk of the composite end point of mortality, stroke, and rehospitalization at 1 year. Conclusions: In patients with severe aortic stenosis and low surgical risk, TAVR with the SAPIEN 3 valve was associated with similar percentage of moderate or severe AR compared with SAVR but higher percentage of mild AR. Transprosthetic gradients, valve areas, percentage of severe prosthesis-patient mismatch, and left ventricular mass regression were similar in TAVR and SAVR. SAVR was associated with significant deterioration of right ventricular systolic function and greater tricuspid regurgitation, which persisted at 1 year. High Z vaand low tricuspid annulus plane systolic excursion were associated with worse outcome at 1 year whereas AR and severe prosthesis-patient mismatch were not. Registration: URL: Https://www.clinicaltrials.gov; Unique identifier: NCT02675114.",

keywords = "aortic valve stenosis, echocardiography, hemodynamics, transcatheter aortic valve replacement",

author = "Philippe Pibarot and Erwan Salaun and Abdellaziz Dahou and Eleonora Avenatti and Ezequiel Guzzetti and Annabi, {Mohamed Salah} and Oumhani Toubal and Mathieu Bernier and Jonathan Beaudoin and G{\'e}raldine Ong and Julien Ternacle and Laura Krapf and Thourani, {Vinod H.} and Raj Makkar and Kodali, {Susheel K.} and Mark Russo and Kapadia, {Samir R.} and Malaisrie, {S. Chris} and Cohen, {David J.} and Jonathon Leipsic and Philipp Blanke and Williams, {Mathew R.} and McCabe, {James M.} and Brown, {David L.} and Vasilis Babaliaros and Scott Goldman and Szeto, {Wilson Y.} and Philippe G{\'e}n{\'e}reux and Ashish Pershad and Alu, {Maria C.} and Ke Xu and Erin Rogers and Webb, {John G.} and Smith, {Craig R.} and Mack, {Michael J.} and Leon, {Martin B.} and Hahn, {Rebecca T.}",

year = "2020",

month = may,

day = "12",

doi = "10.1161/CIRCULATIONAHA.119.044574",

language = "English (US)",

volume = "141",

pages = "1527--1537",

journal = "Circulation",

issn = "0009-7322",

publisher = "Lippincott Williams and Wilkins",

number = "19",

}

Pibarot, P, Salaun, E, Dahou, A, Avenatti, E, Guzzetti, E, Annabi, MS, Toubal, O, Bernier, M, Beaudoin, J, Ong, G, Ternacle, J, Krapf, L, Thourani, VH, Makkar, R, Kodali, SK, Russo, M, Kapadia, SR, Malaisrie, SC, Cohen, DJ, Leipsic, J, Blanke, P, Williams, MR, McCabe, JM, Brown, DL, Babaliaros, V, Goldman, S, Szeto, WY, Généreux, P, Pershad, A, Alu, MC, Xu, K, Rogers, E, Webb, JG, Smith, CR, Mack, MJ, Leon, MB & Hahn, RT 2020, 'Echocardiographic Results of Transcatheter Versus Surgical Aortic Valve Replacement in Low-Risk Patients: The PARTNER 3 Trial', Circulation, vol. 141, no. 19, pp. 1527-1537. https://doi.org/10.1161/CIRCULATIONAHA.119.044574

TY - JOUR

T1 - Echocardiographic Results of Transcatheter Versus Surgical Aortic Valve Replacement in Low-Risk Patients

T2 - The PARTNER 3 Trial

AU - Pibarot, Philippe

AU - Salaun, Erwan

AU - Dahou, Abdellaziz

AU - Avenatti, Eleonora

AU - Guzzetti, Ezequiel

AU - Annabi, Mohamed Salah

AU - Toubal, Oumhani

AU - Bernier, Mathieu

AU - Beaudoin, Jonathan

AU - Ong, Géraldine

AU - Ternacle, Julien

AU - Krapf, Laura

AU - Thourani, Vinod H.

AU - Makkar, Raj

AU - Kodali, Susheel K.

AU - Russo, Mark

AU - Kapadia, Samir R.

AU - Malaisrie, S. Chris

AU - Cohen, David J.

AU - Leipsic, Jonathon

AU - Blanke, Philipp

AU - Williams, Mathew R.

AU - McCabe, James M.

AU - Brown, David L.

AU - Babaliaros, Vasilis

AU - Goldman, Scott

AU - Szeto, Wilson Y.

AU - Généreux, Philippe

AU - Pershad, Ashish

AU - Alu, Maria C.

AU - Xu, Ke

AU - Rogers, Erin

AU - Webb, John G.

AU - Smith, Craig R.

AU - Mack, Michael J.

AU - Leon, Martin B.

AU - Hahn, Rebecca T.

PY - 2020/5/12

Y1 - 2020/5/12

N2 - Background: This study aimed to compare echocardiographic findings in low-risk patients with severe aortic stenosis after surgical aortic valve replacement (SAVR) or transcatheter aortic valve replacement (TAVR). Methods: The PARTNER 3 trial (Placement of Aortic Transcatheter Valves) randomized 1000 patients with severe aortic stenosis and low surgical risk to undergo either transfemoral TAVR with the balloon-expandable SAPIEN 3 valve or SAVR. Transthoracic echocardiograms obtained at baseline and at 30 days and 1 year after the procedure were analyzed by a consortium of 2 echocardiography core laboratories. Results: The percentage of moderate or severe aortic regurgitation (AR) was low and not statistically different between the TAVR and SAVR groups at 30 days (0.8% versus 0.2%; P=0.38). Mild AR was more frequent after TAVR than SAVR at 30 days (28.8% versus 4.2%; P<0.001). At 1 year, mean transvalvular gradient (13.7±5.6 versus 11.6±5.0 mm Hg; P=0.12) and aortic valve area (1.72±0.37 versus 1.76±0.42 cm2; P=0.12) were similar in TAVR and SAVR. The percentage of severe prosthesis-patient mismatch at 30 days was low and similar between TAVR and SAVR (4.6 versus 6.3%; P=0.30). Valvulo-arterial impedance (Z va), which reflects total left ventricular hemodynamic burden, was lower with TAVR than SAVR at 1 year (3.7±0.8 versus 3.9±0.9 mm Hg/mL/m2; P<0.001). Tricuspid annulus plane systolic excursion decreased and the percentage of moderate or severe tricuspid regurgitation increased from baseline to 1 year in SAVR but remained unchanged in TAVR. Irrespective of treatment arm, high Z vaand low tricuspid annulus plane systolic excursion, but not moderate to severe AR or severe prosthesis-patient mismatch, were associated with increased risk of the composite end point of mortality, stroke, and rehospitalization at 1 year. Conclusions: In patients with severe aortic stenosis and low surgical risk, TAVR with the SAPIEN 3 valve was associated with similar percentage of moderate or severe AR compared with SAVR but higher percentage of mild AR. Transprosthetic gradients, valve areas, percentage of severe prosthesis-patient mismatch, and left ventricular mass regression were similar in TAVR and SAVR. SAVR was associated with significant deterioration of right ventricular systolic function and greater tricuspid regurgitation, which persisted at 1 year. High Z vaand low tricuspid annulus plane systolic excursion were associated with worse outcome at 1 year whereas AR and severe prosthesis-patient mismatch were not. Registration: URL: Https://www.clinicaltrials.gov; Unique identifier: NCT02675114.

AB - Background: This study aimed to compare echocardiographic findings in low-risk patients with severe aortic stenosis after surgical aortic valve replacement (SAVR) or transcatheter aortic valve replacement (TAVR). Methods: The PARTNER 3 trial (Placement of Aortic Transcatheter Valves) randomized 1000 patients with severe aortic stenosis and low surgical risk to undergo either transfemoral TAVR with the balloon-expandable SAPIEN 3 valve or SAVR. Transthoracic echocardiograms obtained at baseline and at 30 days and 1 year after the procedure were analyzed by a consortium of 2 echocardiography core laboratories. Results: The percentage of moderate or severe aortic regurgitation (AR) was low and not statistically different between the TAVR and SAVR groups at 30 days (0.8% versus 0.2%; P=0.38). Mild AR was more frequent after TAVR than SAVR at 30 days (28.8% versus 4.2%; P<0.001). At 1 year, mean transvalvular gradient (13.7±5.6 versus 11.6±5.0 mm Hg; P=0.12) and aortic valve area (1.72±0.37 versus 1.76±0.42 cm2; P=0.12) were similar in TAVR and SAVR. The percentage of severe prosthesis-patient mismatch at 30 days was low and similar between TAVR and SAVR (4.6 versus 6.3%; P=0.30). Valvulo-arterial impedance (Z va), which reflects total left ventricular hemodynamic burden, was lower with TAVR than SAVR at 1 year (3.7±0.8 versus 3.9±0.9 mm Hg/mL/m2; P<0.001). Tricuspid annulus plane systolic excursion decreased and the percentage of moderate or severe tricuspid regurgitation increased from baseline to 1 year in SAVR but remained unchanged in TAVR. Irrespective of treatment arm, high Z vaand low tricuspid annulus plane systolic excursion, but not moderate to severe AR or severe prosthesis-patient mismatch, were associated with increased risk of the composite end point of mortality, stroke, and rehospitalization at 1 year. Conclusions: In patients with severe aortic stenosis and low surgical risk, TAVR with the SAPIEN 3 valve was associated with similar percentage of moderate or severe AR compared with SAVR but higher percentage of mild AR. Transprosthetic gradients, valve areas, percentage of severe prosthesis-patient mismatch, and left ventricular mass regression were similar in TAVR and SAVR. SAVR was associated with significant deterioration of right ventricular systolic function and greater tricuspid regurgitation, which persisted at 1 year. High Z vaand low tricuspid annulus plane systolic excursion were associated with worse outcome at 1 year whereas AR and severe prosthesis-patient mismatch were not. Registration: URL: Https://www.clinicaltrials.gov; Unique identifier: NCT02675114.

KW - aortic valve stenosis

KW - echocardiography

KW - hemodynamics

KW - transcatheter aortic valve replacement

UR - http://www.scopus.com/inward/record.url?scp=85084583982&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=85084583982&partnerID=8YFLogxK

U2 - 10.1161/CIRCULATIONAHA.119.044574

DO - 10.1161/CIRCULATIONAHA.119.044574

M3 - Article

C2 - 32272848

AN - SCOPUS:85084583982

SN - 0009-7322

VL - 141

SP - 1527

EP - 1537

JO - Circulation

JF - Circulation

IS - 19

ER -

Echocardiographic Results of Transcatheter Versus Surgical Aortic Valve Replacement in Low-Risk Patients: The PARTNER 3 Trial

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