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
N1 - Funding Information:
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.
Funding Information:
The PARTNER II trial was supported by Edwards Lifesciences.
Publisher Copyright:
© 2019 Lippincott Williams and Wilkins. All rights reserved.
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
C2 - 31525069
AN - SCOPUS:85072261088
SN - 1941-3289
VL - 12
JO - Circulation: Heart Failure
JF - Circulation: Heart Failure
IS - 8
M1 - e005809
ER -
