Effect of baseline left ventricular ejection fraction on 2-year outcomes after transcatheter aortic valve replacement: Analysis of the PARTNER 2 Trials

Ariel Furer; Shmuel Chen; Bjorn Redfors; Sammy Elmariah; Philippe Pibarot; Howard C. Herrmann; Rebecca T. Hahn; Susheel Kodali; Vinod H. Thourani; Pamela S. Douglas; Maria C. Alu; William F. Fearon; Jonathan Passeri; S. Chris Malaisrie; Aaron Crowley; Thomas McAndrew; Philippe Genereux; Ori Ben-Yehuda; Martin B. Leon; Daniel Burkhoff

doi:10.1161/CIRCHEARTFAILURE.118.005809

Effect of baseline left ventricular ejection fraction on 2-year outcomes after transcatheter aortic valve replacement: Analysis of the PARTNER 2 Trials

Ariel Furer, Shmuel Chen, Bjorn Redfors, Sammy Elmariah, Philippe Pibarot, Howard C. Herrmann, Rebecca T. Hahn, Susheel Kodali, Vinod H. Thourani, Pamela S. Douglas, Maria C. Alu, William F. Fearon, Jonathan Passeri, S. Chris Malaisrie, Aaron Crowley, Thomas McAndrew, Philippe Genereux, Ori Ben-Yehuda, Martin B. Leon, Daniel Burkhoff^*

^*Corresponding author for this work

Surgery, Cardiac Surgery Division

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

40 Scopus citations

Abstract

Background: Impaired left ventricular function is associated with worse prognosis among patients with aortic stenosis treated medically or with surgical aortic valve replacement. It is unclear whether reduced left ventricular ejection fraction (LVEF) is an independent predictor of adverse outcomes after transcatheter aortic valve replacement. Methods and Results: Patients who underwent transcatheter aortic valve replacement in the PARTNER 2 trials (Placement of Aortic Transcatheter Valves) and registries were stratified according to presence of reduced LVEF (<50%) at baseline, and 2-year risk of cardiovascular mortality was compared using Kaplan-Meier methods and multivariable Cox proportional hazards regression. Of 2991 patients, 839 (28%) had reduced LVEF. These patients were younger, more often males, and were more likely to have comorbidities, such as coronary disease, diabetes mellitus, and renal insufficiency. Compared with patients with normal LVEF, patients with low LVEF had higher crude rates of 2-year cardiovascular mortality (19.8% versus 12.0%, P<0.0001) and all-cause mortality (27.4% versus 19.2%, P<0.0001). Mean aortic valve gradient was not associated with clinical outcomes other than heart failure hospitalizations (hazard ratio [HR], 0.99; CI, 0.99-1.00; P=0.03). After multivariable adjustment, patients with reduced versus normal LVEF had significantly higher adjusted risk of cardiovascular death (adjusted HR, 1.42, 95% CI, 1.11-1.81; P=0.005), but not all-cause death (adjusted HR, 1.20; 95% CI, 0.99-1.47; P=0.07). When LVEF was treated as continuous variable, it was associated with increased 2-year risk of both cardiovascular mortality (adjusted HR per 10% decrease in LVEF, 1.16; 95% CI, 1.07-1.27; P=0.0006) and all-cause mortality (adjusted HR, 1.09; 95% CI, 1.01-1.16; P=0.02). Conclusions: In this patient-level pooled analysis of PARTNER 2 patients who underwent transcatheter aortic valve replacement, baseline LVEF was an independent predictor of 2-year cardiovascular mortality. Clinical Trial Registration: URL: https://www.clinicaltrials.gov. Unique identifiers: NCT01314313, NCT02184442, NCT03222128, and NCT02184441.

Original language	English (US)
Article number	e005809
Journal	Circulation: Heart Failure
Volume	12
Issue number	8
DOIs	https://doi.org/10.1161/CIRCHEARTFAILURE.118.005809
State	Published - Aug 1 2019

Funding

Dr Elmariah reports institutional research grants from Siemens and Boehringer Ingelheim Pharmaceuticals and modest honoraria from Medtronic and Edwards Lifesciences. Dr Pibarot is the Canada Research Chair in Valvular Heart Disease; his research program is funded by the Canadian Institutes of Health Research (grant FDN-143225), Ottawa, Ontario, Canada. He also reports research grants from Edwards Lifesciences and Medtronic for echocardiography core laboratory analyses in transcatheter heart valves. Dr Herrmann reports institutional research grants from Abbott Vascular, Boston Scientific, Edwards Lifesciences, and Medtronic and modest honoraria from Edwards Lifesciences. Dr Hahn reports honoraria from Abbott Vascular, Boston Scientific, Bayliss, Edwards Lifesciences, Philips Healthcare and Siemens Healthineers, and advisory board participation for 3Mensio, Abbott Vascular, Edwards Lifesciences, GE Healthcare, Gore&Associates, Medtronic, Navigate, Philips Healthcare, and Siemens Healthineers. She is the Chief Scientific Officer for the Echocardiography Core Laboratory at the Cardiovascular Research Foundation. Dr Kodali reports honoraria from Abbott Vascular and Claret Medical, and scientific advisory board membership for Thubrikar Aortic Valve, Inc., Dura Biotech, and Biotrace Medical. Dr Thourani reports advisory board participation for Edwards Lifesciences, Abbott Vascular, Gore Vascular, Bard Medical, JenaValve, and Boston Scientific. Dr Fearon reports research support from St. Jude Medical. Dr Malaisrie reports modest honoraria from Edwards Lifesciences, Medtronic, and Abbott. Dr Genereux reports a research grant to his institution from Boston Scientific, modest honoraria from Abbott Vascular, Edwards Lifesciences, Medtronic, Tryton Medical, Inc, Cardinal Health, Cardiovascular Systems, Inc, Boston Scientific, and Pi-Cardia, and equity in SIG.NUM, SoundBit Medical Solutions, Inc, Saranas, and Pi-Cardia. Dr Leon is a member of the PARTNER Executive Committee (no direct compensation). The other authors report no conflicts. The PARTNER II trial was supported by Edwards Lifesciences.

Keywords

aortic valve
diabetes mellitus
heart failure
renal insufficiency
transcatheter aortic valve replacement

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/CIRCHEARTFAILURE.118.005809

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Furer, A., Chen, S., Redfors, B., Elmariah, S., Pibarot, P., Herrmann, H. C., Hahn, R. T., Kodali, S., Thourani, V. H., Douglas, P. S., Alu, M. C., Fearon, W. F., Passeri, J., Malaisrie, S. C., Crowley, A., McAndrew, T., Genereux, P., Ben-Yehuda, O., Leon, M. B., & Burkhoff, D. (2019). Effect of baseline left ventricular ejection fraction on 2-year outcomes after transcatheter aortic valve replacement: Analysis of the PARTNER 2 Trials. Circulation: Heart Failure, 12(8), Article e005809. https://doi.org/10.1161/CIRCHEARTFAILURE.118.005809

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title = "Effect of baseline left ventricular ejection fraction on 2-year outcomes after transcatheter aortic valve replacement: Analysis of the PARTNER 2 Trials",

abstract = "Background: Impaired left ventricular function is associated with worse prognosis among patients with aortic stenosis treated medically or with surgical aortic valve replacement. It is unclear whether reduced left ventricular ejection fraction (LVEF) is an independent predictor of adverse outcomes after transcatheter aortic valve replacement. Methods and Results: Patients who underwent transcatheter aortic valve replacement in the PARTNER 2 trials (Placement of Aortic Transcatheter Valves) and registries were stratified according to presence of reduced LVEF (<50%) at baseline, and 2-year risk of cardiovascular mortality was compared using Kaplan-Meier methods and multivariable Cox proportional hazards regression. Of 2991 patients, 839 (28%) had reduced LVEF. These patients were younger, more often males, and were more likely to have comorbidities, such as coronary disease, diabetes mellitus, and renal insufficiency. Compared with patients with normal LVEF, patients with low LVEF had higher crude rates of 2-year cardiovascular mortality (19.8% versus 12.0%, P<0.0001) and all-cause mortality (27.4% versus 19.2%, P<0.0001). Mean aortic valve gradient was not associated with clinical outcomes other than heart failure hospitalizations (hazard ratio [HR], 0.99; CI, 0.99-1.00; P=0.03). After multivariable adjustment, patients with reduced versus normal LVEF had significantly higher adjusted risk of cardiovascular death (adjusted HR, 1.42, 95% CI, 1.11-1.81; P=0.005), but not all-cause death (adjusted HR, 1.20; 95% CI, 0.99-1.47; P=0.07). When LVEF was treated as continuous variable, it was associated with increased 2-year risk of both cardiovascular mortality (adjusted HR per 10% decrease in LVEF, 1.16; 95% CI, 1.07-1.27; P=0.0006) and all-cause mortality (adjusted HR, 1.09; 95% CI, 1.01-1.16; P=0.02). Conclusions: In this patient-level pooled analysis of PARTNER 2 patients who underwent transcatheter aortic valve replacement, baseline LVEF was an independent predictor of 2-year cardiovascular mortality. Clinical Trial Registration: URL: https://www.clinicaltrials.gov. Unique identifiers: NCT01314313, NCT02184442, NCT03222128, and NCT02184441.",

keywords = "aortic valve, diabetes mellitus, heart failure, renal insufficiency, transcatheter aortic valve replacement",

author = "Ariel Furer and Shmuel Chen and Bjorn Redfors and Sammy Elmariah and Philippe Pibarot and Herrmann, {Howard C.} and Hahn, {Rebecca T.} and Susheel Kodali and Thourani, {Vinod H.} and Douglas, {Pamela S.} and Alu, {Maria C.} and Fearon, {William F.} and Jonathan Passeri and Malaisrie, {S. Chris} and Aaron Crowley and Thomas McAndrew and Philippe Genereux and Ori Ben-Yehuda and Leon, {Martin B.} and Daniel Burkhoff",

year = "2019",

month = aug,

day = "1",

doi = "10.1161/CIRCHEARTFAILURE.118.005809",

language = "English (US)",

volume = "12",

journal = "Circulation: Heart Failure",

issn = "1941-3289",

publisher = "Lippincott Williams and Wilkins",

number = "8",

}

Furer, A, Chen, S, Redfors, B, Elmariah, S, Pibarot, P, Herrmann, HC, Hahn, RT, Kodali, S, Thourani, VH, Douglas, PS, Alu, MC, Fearon, WF, Passeri, J, Malaisrie, SC, Crowley, A, McAndrew, T, Genereux, P, Ben-Yehuda, O, Leon, MB & Burkhoff, D 2019, 'Effect of baseline left ventricular ejection fraction on 2-year outcomes after transcatheter aortic valve replacement: Analysis of the PARTNER 2 Trials', Circulation: Heart Failure, vol. 12, no. 8, e005809. https://doi.org/10.1161/CIRCHEARTFAILURE.118.005809

TY - JOUR

T1 - Effect of baseline left ventricular ejection fraction on 2-year outcomes after transcatheter aortic valve replacement

T2 - Analysis of the PARTNER 2 Trials

AU - Furer, Ariel

AU - Chen, Shmuel

AU - Redfors, Bjorn

AU - Elmariah, Sammy

AU - Pibarot, Philippe

AU - Herrmann, Howard C.

AU - Hahn, Rebecca T.

AU - Kodali, Susheel

AU - Thourani, Vinod H.

AU - Douglas, Pamela S.

AU - Alu, Maria C.

AU - Fearon, William F.

AU - Passeri, Jonathan

AU - Malaisrie, S. Chris

AU - Crowley, Aaron

AU - McAndrew, Thomas

AU - Genereux, Philippe

AU - Ben-Yehuda, Ori

AU - Leon, Martin B.

AU - Burkhoff, Daniel

PY - 2019/8/1

Y1 - 2019/8/1

N2 - Background: Impaired left ventricular function is associated with worse prognosis among patients with aortic stenosis treated medically or with surgical aortic valve replacement. It is unclear whether reduced left ventricular ejection fraction (LVEF) is an independent predictor of adverse outcomes after transcatheter aortic valve replacement. Methods and Results: Patients who underwent transcatheter aortic valve replacement in the PARTNER 2 trials (Placement of Aortic Transcatheter Valves) and registries were stratified according to presence of reduced LVEF (<50%) at baseline, and 2-year risk of cardiovascular mortality was compared using Kaplan-Meier methods and multivariable Cox proportional hazards regression. Of 2991 patients, 839 (28%) had reduced LVEF. These patients were younger, more often males, and were more likely to have comorbidities, such as coronary disease, diabetes mellitus, and renal insufficiency. Compared with patients with normal LVEF, patients with low LVEF had higher crude rates of 2-year cardiovascular mortality (19.8% versus 12.0%, P<0.0001) and all-cause mortality (27.4% versus 19.2%, P<0.0001). Mean aortic valve gradient was not associated with clinical outcomes other than heart failure hospitalizations (hazard ratio [HR], 0.99; CI, 0.99-1.00; P=0.03). After multivariable adjustment, patients with reduced versus normal LVEF had significantly higher adjusted risk of cardiovascular death (adjusted HR, 1.42, 95% CI, 1.11-1.81; P=0.005), but not all-cause death (adjusted HR, 1.20; 95% CI, 0.99-1.47; P=0.07). When LVEF was treated as continuous variable, it was associated with increased 2-year risk of both cardiovascular mortality (adjusted HR per 10% decrease in LVEF, 1.16; 95% CI, 1.07-1.27; P=0.0006) and all-cause mortality (adjusted HR, 1.09; 95% CI, 1.01-1.16; P=0.02). Conclusions: In this patient-level pooled analysis of PARTNER 2 patients who underwent transcatheter aortic valve replacement, baseline LVEF was an independent predictor of 2-year cardiovascular mortality. Clinical Trial Registration: URL: https://www.clinicaltrials.gov. Unique identifiers: NCT01314313, NCT02184442, NCT03222128, and NCT02184441.

AB - Background: Impaired left ventricular function is associated with worse prognosis among patients with aortic stenosis treated medically or with surgical aortic valve replacement. It is unclear whether reduced left ventricular ejection fraction (LVEF) is an independent predictor of adverse outcomes after transcatheter aortic valve replacement. Methods and Results: Patients who underwent transcatheter aortic valve replacement in the PARTNER 2 trials (Placement of Aortic Transcatheter Valves) and registries were stratified according to presence of reduced LVEF (<50%) at baseline, and 2-year risk of cardiovascular mortality was compared using Kaplan-Meier methods and multivariable Cox proportional hazards regression. Of 2991 patients, 839 (28%) had reduced LVEF. These patients were younger, more often males, and were more likely to have comorbidities, such as coronary disease, diabetes mellitus, and renal insufficiency. Compared with patients with normal LVEF, patients with low LVEF had higher crude rates of 2-year cardiovascular mortality (19.8% versus 12.0%, P<0.0001) and all-cause mortality (27.4% versus 19.2%, P<0.0001). Mean aortic valve gradient was not associated with clinical outcomes other than heart failure hospitalizations (hazard ratio [HR], 0.99; CI, 0.99-1.00; P=0.03). After multivariable adjustment, patients with reduced versus normal LVEF had significantly higher adjusted risk of cardiovascular death (adjusted HR, 1.42, 95% CI, 1.11-1.81; P=0.005), but not all-cause death (adjusted HR, 1.20; 95% CI, 0.99-1.47; P=0.07). When LVEF was treated as continuous variable, it was associated with increased 2-year risk of both cardiovascular mortality (adjusted HR per 10% decrease in LVEF, 1.16; 95% CI, 1.07-1.27; P=0.0006) and all-cause mortality (adjusted HR, 1.09; 95% CI, 1.01-1.16; P=0.02). Conclusions: In this patient-level pooled analysis of PARTNER 2 patients who underwent transcatheter aortic valve replacement, baseline LVEF was an independent predictor of 2-year cardiovascular mortality. Clinical Trial Registration: URL: https://www.clinicaltrials.gov. Unique identifiers: NCT01314313, NCT02184442, NCT03222128, and NCT02184441.

KW - aortic valve

KW - diabetes mellitus

KW - heart failure

KW - renal insufficiency

KW - transcatheter aortic valve replacement

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U2 - 10.1161/CIRCHEARTFAILURE.118.005809

DO - 10.1161/CIRCHEARTFAILURE.118.005809

M3 - Article

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AN - SCOPUS:85072261088

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VL - 12

JO - Circulation: Heart Failure

JF - Circulation: Heart Failure

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ER -

Effect of baseline left ventricular ejection fraction on 2-year outcomes after transcatheter aortic valve replacement: Analysis of the PARTNER 2 Trials

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UN SDGs

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