Incidence and Clinical Significance of Worsening Tricuspid Regurgitation Following Surgical or Transcatheter Aortic Valve Replacement: Analysis From the PARTNER IIA Trial

Paul C. Cremer; Tom Kai Ming Wang; L. Leonardo Rodriguez; Brian R. Lindman; Yiran Zhang; Alan Zajarias; Rebecca T. Hahn; Stamatios Lerakis; S. Chris Malaisrie; Pamela S. Douglas; Philippe Pibarot; Lars G. Svensson; Samir Kapadia; Martin B. Leon; Wael A. Jaber

doi:10.1161/CIRCINTERVENTIONS.120.010437

Incidence and Clinical Significance of Worsening Tricuspid Regurgitation Following Surgical or Transcatheter Aortic Valve Replacement: Analysis From the PARTNER IIA Trial

Paul C. Cremer, Tom Kai Ming Wang, L. Leonardo Rodriguez, Brian R. Lindman, Yiran Zhang, Alan Zajarias, Rebecca T. Hahn, Stamatios Lerakis, S. Chris Malaisrie, Pamela S. Douglas, Philippe Pibarot, Lars G. Svensson, Samir Kapadia, Martin B. Leon, Wael A. Jaber^*

^*Corresponding author for this work

Surgery, Cardiac Surgery Division

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

22 Scopus citations

Abstract

Background: Aortic valve replacement (AVR) is recommended for severe symptomatic aortic stenosis. However, the incidence of worsening tricuspid regurgitation (TR) following transcatheter compared with surgical AVR (TAVR, SAVR), and the impact of worsening TR on outcomes, is ill-defined. Accordingly, among patients randomized to TAVR or SAVR, we describe the differential incidence of worsening TR and its association with survival. Methods: From the PARTNER IIA trial (Placement of Aortic Transcatheter Valves IIA), 1334 patients were included with baseline and 30-day postprocedure core-lab echocardiograms. Worsening TR was defined as deterioration of ≥1 grade from baseline to 30 days. Outcomes included cardiovascular and all-cause death between 30 days and 2 years. Multivariable logistic regression was performed to identify associations with worsening TR; survival analyses were performed to assess associations with mortality. Results: Worsening TR occurred in 17.3% (125/721) of TAVR and 27.0% (165/611) of SAVR patients. On multivariable analysis, SAVR (odds ratio, 2.09 [95% CI, 1.40-3.11]), female sex (odds ratio, 2.22 [95% CI, 1.44-3.42]), atrial fibrillation (odds ratio, 1.61 [95% CI, 1.03-2.51]), and right ventricular enlargement (odds ratio, 2.25 [95% CI, 1.17-4.31]) were associated with worsening TR. Cardiovascular and all-cause death occurred in 9.0% (26/290) and 17.9% (52/290) of patients with worsening TR, compared with 4.8% (50/1042) and 10.9% (114/1042) without worsening TR, respectively. In patients with worsening TR, cardiovascular and all-cause death were similar in TAVR compared with SAVR, (hazard ratio, 1.09 [95% CI, 0.55-2.16]) and (hazard ratio, 1.07 [95% CI, 0.62-1.87]), respectively. After adjustment, worsening TR was independently associated with cardiovascular (hazard ratio, 3.62 [95% CI, 2.08-6.29]) and all-cause death (hazard ratio, 2.11 [95% CI, 1.37-3.27]). Conclusions: Worsening TR is associated with female sex, atrial fibrillation, right ventricular enlargement, and SAVR. Regardless of mode of AVR, worsening TR is similarly associated with a poor prognosis. Future studies should focus on whether preventing or treating worsening TR improves outcomes. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT01314313.

Original language	English (US)
Pages (from-to)	E010437
Journal	Circulation: Cardiovascular Interventions
Volume	14
Issue number	8
DOIs	https://doi.org/10.1161/CIRCINTERVENTIONS.120.010437
State	Published - Aug 1 2021

Funding

Drs Jaber and Cremer have echocardiography core laboratory contracts with Edwards Lifesciences (no direct compensation). Dr Lindman has served on the scientific advisory board for Roche Diagnostics; has received research grants from Edwards Lifesciences and Roche Diagnostics; and has served as a consultant for Medtronic. Dr Hahn has received speaker fees from Boston Scientific Corporation, Baylis Medical, Edwards Lifesciences, and Medtronic; has served as a consultant for Abbott Structural, Edwards Lifesciences, Gore and Associates, Medtronic, Navigate, Philips Healthcare, and Siemens Healthcare; has received nonfinancial support from 3mensio and GE Healthcare; and has served as 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 Douglas institution has received research grant support from Edwards Lifesciences. Dr Pibarot has research contracts with Edwards Lifesciences (no personal compensation) Dr Leon has received institutional research funding from Edwards Lifesciences, Medtronic, Boston Scientific, and Abbott; has served as a consultant for Medtronic, Boston Scientific, Gore Medical, Meril Lifesciences, and Abbott; and has served as a member of the Executive Committee for the PARTNER trials (Placement of Aor- tic Transcatheter Valves IIA; no direct compensation). The other authors report no conflicts. The PARTNER 2 trial (Placement of Aortic Transcatheter Valves IIA) was funded by Edwards Lifesciences and the protocol was designed collaboratively by the Sponsor and the Steering Committee. The present analysis was performed by academic investigators through the PARTNER Publications Office with no direct involvement of the sponsor in the analysis, drafting of the article, or the decision to publish.

Keywords

aortic valve
aortic valve stenosis
echocardiography
transcatheter aortic valve replacement
tricuspid valve insufficiency

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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10.1161/CIRCINTERVENTIONS.120.010437

Cite this

Cremer, P. C., Wang, T. K. M., Rodriguez, L. L., Lindman, B. R., Zhang, Y., Zajarias, A., Hahn, R. T., Lerakis, S., Malaisrie, S. C., Douglas, P. S., Pibarot, P., Svensson, L. G., Kapadia, S., Leon, M. B., & Jaber, W. A. (2021). Incidence and Clinical Significance of Worsening Tricuspid Regurgitation Following Surgical or Transcatheter Aortic Valve Replacement: Analysis From the PARTNER IIA Trial. Circulation: Cardiovascular Interventions, 14(8), E010437. https://doi.org/10.1161/CIRCINTERVENTIONS.120.010437

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title = "Incidence and Clinical Significance of Worsening Tricuspid Regurgitation Following Surgical or Transcatheter Aortic Valve Replacement: Analysis From the PARTNER IIA Trial",

abstract = "Background: Aortic valve replacement (AVR) is recommended for severe symptomatic aortic stenosis. However, the incidence of worsening tricuspid regurgitation (TR) following transcatheter compared with surgical AVR (TAVR, SAVR), and the impact of worsening TR on outcomes, is ill-defined. Accordingly, among patients randomized to TAVR or SAVR, we describe the differential incidence of worsening TR and its association with survival. Methods: From the PARTNER IIA trial (Placement of Aortic Transcatheter Valves IIA), 1334 patients were included with baseline and 30-day postprocedure core-lab echocardiograms. Worsening TR was defined as deterioration of ≥1 grade from baseline to 30 days. Outcomes included cardiovascular and all-cause death between 30 days and 2 years. Multivariable logistic regression was performed to identify associations with worsening TR; survival analyses were performed to assess associations with mortality. Results: Worsening TR occurred in 17.3% (125/721) of TAVR and 27.0% (165/611) of SAVR patients. On multivariable analysis, SAVR (odds ratio, 2.09 [95% CI, 1.40-3.11]), female sex (odds ratio, 2.22 [95% CI, 1.44-3.42]), atrial fibrillation (odds ratio, 1.61 [95% CI, 1.03-2.51]), and right ventricular enlargement (odds ratio, 2.25 [95% CI, 1.17-4.31]) were associated with worsening TR. Cardiovascular and all-cause death occurred in 9.0% (26/290) and 17.9% (52/290) of patients with worsening TR, compared with 4.8% (50/1042) and 10.9% (114/1042) without worsening TR, respectively. In patients with worsening TR, cardiovascular and all-cause death were similar in TAVR compared with SAVR, (hazard ratio, 1.09 [95% CI, 0.55-2.16]) and (hazard ratio, 1.07 [95% CI, 0.62-1.87]), respectively. After adjustment, worsening TR was independently associated with cardiovascular (hazard ratio, 3.62 [95% CI, 2.08-6.29]) and all-cause death (hazard ratio, 2.11 [95% CI, 1.37-3.27]). Conclusions: Worsening TR is associated with female sex, atrial fibrillation, right ventricular enlargement, and SAVR. Regardless of mode of AVR, worsening TR is similarly associated with a poor prognosis. Future studies should focus on whether preventing or treating worsening TR improves outcomes. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT01314313.",

keywords = "aortic valve, aortic valve stenosis, echocardiography, transcatheter aortic valve replacement, tricuspid valve insufficiency",

author = "Cremer, {Paul C.} and Wang, {Tom Kai Ming} and Rodriguez, {L. Leonardo} and Lindman, {Brian R.} and Yiran Zhang and Alan Zajarias and Hahn, {Rebecca T.} and Stamatios Lerakis and Malaisrie, {S. Chris} and Douglas, {Pamela S.} and Philippe Pibarot and Svensson, {Lars G.} and Samir Kapadia and Leon, {Martin B.} and Jaber, {Wael A.}",

year = "2021",

month = aug,

day = "1",

doi = "10.1161/CIRCINTERVENTIONS.120.010437",

language = "English (US)",

volume = "14",

pages = "E010437",

journal = "Circulation: Cardiovascular Interventions",

issn = "1941-7640",

publisher = "Lippincott Williams and Wilkins Ltd.",

number = "8",

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Cremer, PC, Wang, TKM, Rodriguez, LL, Lindman, BR, Zhang, Y, Zajarias, A, Hahn, RT, Lerakis, S, Malaisrie, SC, Douglas, PS, Pibarot, P, Svensson, LG, Kapadia, S, Leon, MB & Jaber, WA 2021, 'Incidence and Clinical Significance of Worsening Tricuspid Regurgitation Following Surgical or Transcatheter Aortic Valve Replacement: Analysis From the PARTNER IIA Trial', Circulation: Cardiovascular Interventions, vol. 14, no. 8, pp. E010437. https://doi.org/10.1161/CIRCINTERVENTIONS.120.010437

Incidence and Clinical Significance of Worsening Tricuspid Regurgitation Following Surgical or Transcatheter Aortic Valve Replacement: Analysis From the PARTNER IIA Trial. / Cremer, Paul C.; Wang, Tom Kai Ming; Rodriguez, L. Leonardo et al.
In: Circulation: Cardiovascular Interventions, Vol. 14, No. 8, 01.08.2021, p. E010437.

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

TY - JOUR

T1 - Incidence and Clinical Significance of Worsening Tricuspid Regurgitation Following Surgical or Transcatheter Aortic Valve Replacement

T2 - Analysis From the PARTNER IIA Trial

AU - Cremer, Paul C.

AU - Wang, Tom Kai Ming

AU - Rodriguez, L. Leonardo

AU - Lindman, Brian R.

AU - Zhang, Yiran

AU - Zajarias, Alan

AU - Hahn, Rebecca T.

AU - Lerakis, Stamatios

AU - Malaisrie, S. Chris

AU - Douglas, Pamela S.

AU - Pibarot, Philippe

AU - Svensson, Lars G.

AU - Kapadia, Samir

AU - Leon, Martin B.

AU - Jaber, Wael A.

PY - 2021/8/1

Y1 - 2021/8/1

N2 - Background: Aortic valve replacement (AVR) is recommended for severe symptomatic aortic stenosis. However, the incidence of worsening tricuspid regurgitation (TR) following transcatheter compared with surgical AVR (TAVR, SAVR), and the impact of worsening TR on outcomes, is ill-defined. Accordingly, among patients randomized to TAVR or SAVR, we describe the differential incidence of worsening TR and its association with survival. Methods: From the PARTNER IIA trial (Placement of Aortic Transcatheter Valves IIA), 1334 patients were included with baseline and 30-day postprocedure core-lab echocardiograms. Worsening TR was defined as deterioration of ≥1 grade from baseline to 30 days. Outcomes included cardiovascular and all-cause death between 30 days and 2 years. Multivariable logistic regression was performed to identify associations with worsening TR; survival analyses were performed to assess associations with mortality. Results: Worsening TR occurred in 17.3% (125/721) of TAVR and 27.0% (165/611) of SAVR patients. On multivariable analysis, SAVR (odds ratio, 2.09 [95% CI, 1.40-3.11]), female sex (odds ratio, 2.22 [95% CI, 1.44-3.42]), atrial fibrillation (odds ratio, 1.61 [95% CI, 1.03-2.51]), and right ventricular enlargement (odds ratio, 2.25 [95% CI, 1.17-4.31]) were associated with worsening TR. Cardiovascular and all-cause death occurred in 9.0% (26/290) and 17.9% (52/290) of patients with worsening TR, compared with 4.8% (50/1042) and 10.9% (114/1042) without worsening TR, respectively. In patients with worsening TR, cardiovascular and all-cause death were similar in TAVR compared with SAVR, (hazard ratio, 1.09 [95% CI, 0.55-2.16]) and (hazard ratio, 1.07 [95% CI, 0.62-1.87]), respectively. After adjustment, worsening TR was independently associated with cardiovascular (hazard ratio, 3.62 [95% CI, 2.08-6.29]) and all-cause death (hazard ratio, 2.11 [95% CI, 1.37-3.27]). Conclusions: Worsening TR is associated with female sex, atrial fibrillation, right ventricular enlargement, and SAVR. Regardless of mode of AVR, worsening TR is similarly associated with a poor prognosis. Future studies should focus on whether preventing or treating worsening TR improves outcomes. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT01314313.

AB - Background: Aortic valve replacement (AVR) is recommended for severe symptomatic aortic stenosis. However, the incidence of worsening tricuspid regurgitation (TR) following transcatheter compared with surgical AVR (TAVR, SAVR), and the impact of worsening TR on outcomes, is ill-defined. Accordingly, among patients randomized to TAVR or SAVR, we describe the differential incidence of worsening TR and its association with survival. Methods: From the PARTNER IIA trial (Placement of Aortic Transcatheter Valves IIA), 1334 patients were included with baseline and 30-day postprocedure core-lab echocardiograms. Worsening TR was defined as deterioration of ≥1 grade from baseline to 30 days. Outcomes included cardiovascular and all-cause death between 30 days and 2 years. Multivariable logistic regression was performed to identify associations with worsening TR; survival analyses were performed to assess associations with mortality. Results: Worsening TR occurred in 17.3% (125/721) of TAVR and 27.0% (165/611) of SAVR patients. On multivariable analysis, SAVR (odds ratio, 2.09 [95% CI, 1.40-3.11]), female sex (odds ratio, 2.22 [95% CI, 1.44-3.42]), atrial fibrillation (odds ratio, 1.61 [95% CI, 1.03-2.51]), and right ventricular enlargement (odds ratio, 2.25 [95% CI, 1.17-4.31]) were associated with worsening TR. Cardiovascular and all-cause death occurred in 9.0% (26/290) and 17.9% (52/290) of patients with worsening TR, compared with 4.8% (50/1042) and 10.9% (114/1042) without worsening TR, respectively. In patients with worsening TR, cardiovascular and all-cause death were similar in TAVR compared with SAVR, (hazard ratio, 1.09 [95% CI, 0.55-2.16]) and (hazard ratio, 1.07 [95% CI, 0.62-1.87]), respectively. After adjustment, worsening TR was independently associated with cardiovascular (hazard ratio, 3.62 [95% CI, 2.08-6.29]) and all-cause death (hazard ratio, 2.11 [95% CI, 1.37-3.27]). Conclusions: Worsening TR is associated with female sex, atrial fibrillation, right ventricular enlargement, and SAVR. Regardless of mode of AVR, worsening TR is similarly associated with a poor prognosis. Future studies should focus on whether preventing or treating worsening TR improves outcomes. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT01314313.

KW - aortic valve

KW - aortic valve stenosis

KW - echocardiography

KW - transcatheter aortic valve replacement

KW - tricuspid valve insufficiency

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AN - SCOPUS:85113746034

SN - 1941-7640

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Incidence and Clinical Significance of Worsening Tricuspid Regurgitation Following Surgical or Transcatheter Aortic Valve Replacement: Analysis From the PARTNER IIA Trial

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UN SDGs

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