Association of transcatheter aortic valve replacement with 30-day renal function and 1-year outcomes among patients presenting with compromised baseline renal function experience from the PARTNER 1 trial and registry

TY - JOUR

T1 - Association of transcatheter aortic valve replacement with 30-day renal function and 1-year outcomes among patients presenting with compromised baseline renal function experience from the PARTNER 1 trial and registry

AU - Beohar, Nirat

AU - Doshi, Darshan

AU - Thourani, Vinod

AU - Jensen, Hanna

AU - Kodali, Susheel

AU - Zhang, Feifan

AU - Zhang, Yiran

AU - Davidson, Charles J

AU - McCarthy, Patrick M

AU - Mack, Michael

AU - Kapadia, Samir

AU - Leon, Martin

AU - Kirtane, Ajay

PY - 2017/7/1

Y1 - 2017/7/1

N2 - IMPORTANCE The frequency of baseline renal impairment among high-risk and inoperable patients with severe aortic stenosis undergoing a transcatheter aortic valve replacement (TAVR) and the effect of TAVR on subsequent renal function are, to our knowledge, unknown. OBJECTIVE To determine the effect of TAVR among patients with baseline renal impairment. DESIGN, SETTING, AND PARTICIPANTS This substudy of patients with baseline renal impairment (estimated glomerular filtration rate [EGFR]60 mL/min) and paired baseline and 30-day measures of renal function undergoing TAVR in the PARTNER 1 trial and continued access registries was conducted in 25 centers in the United States and Canada. MAIN OUTCOMES AND MEASURES Patientswere categorized with improved EGFR (30-day follow-up EGFR10% higher than baseline pre-TAVR), worsened EGFR (10% lower), or no change in renal function (neither). Baseline characteristics, 30-day to 1-year all-cause mortality, and repeat hospitalization were compared. Multivariable models were constructed to identify predictors of 1-year mortality and of improvement/worsening in EGFR. RESULTS Of the 821 participants,401 (48.8%)werewomen and the mean (SD) age for participants with improved, unchanged, orworsening EGFRwas 84.90(6.91) years, 84.37 (7.13) years, and 85.39 (6.40) years, respectively. The EGFRwas 60mL/min or lower among 821 patients (72%), ofwhom345 (42%) improved, 196 (24%)worsened, and 280 (34%) had no change at 30 days. Therewere no differences in baseline age, body mass index, diabetes, chronic obstructive pulmonary disease, coronary artery disease, peripheral arterial disease, hypertension, pulmonary hypertension, renal or liver disease,NewYork Heart Association III/IV symptoms, transaortic gradient, left ventricular ejection fraction, or procedural characteristics. The group with improved EGFR had morewomen, nonsmokers, and a lower cardiac index. Those with worsening EGFR had a higher median Society of Thoracic Surgeons score and left ventricle mass. From 30 days to 1 year, those with improved EGFR had no difference in mortality or repeat hospitalization. Those withworsening EGFR had increased mortality (25.5%vs 19.1%, P = .07) but no significant increases in repeat hospitalization or dialysis. Predictors of improved EGFRwere being female (odds ratio [OR], 1.38; 95%CI, 1.03-1.85; P = .03) and nonsmoking status (OR, 1.49; 95%CI, 1.11-1.01; P = .01); predictors ofworsening EGFRwere baseline left ventricle mass (OR, 1.00; 95%CI, 1.00-1.01; P = .01), smoking (OR, 1.51; 95%CI, 1.06-2.14; P = .02), and age (OR, 1.03; 95%CI, 1.00-1.05; P = .05); and predictors of 1-year mortalitywere baseline left ventricular ejection fraction (OR,0.98; 95%CI,0.97-0.99; P = .003), baseline EGFR (OR,0.98; 95%CI,0.96-0.99; P < .001), andworsening EGFR vs no change in EGFR (OR, 1.51; 95%CI, 1.02-2.24; P = .04). CONCLUSIONS AND RELEVANCE Baseline renal impairment was frequent among patients who underwent TAVR. While improved EGFR did not improve 1-year outcomes, worsening EGFR was associated with increased mortality.

AB - IMPORTANCE The frequency of baseline renal impairment among high-risk and inoperable patients with severe aortic stenosis undergoing a transcatheter aortic valve replacement (TAVR) and the effect of TAVR on subsequent renal function are, to our knowledge, unknown. OBJECTIVE To determine the effect of TAVR among patients with baseline renal impairment. DESIGN, SETTING, AND PARTICIPANTS This substudy of patients with baseline renal impairment (estimated glomerular filtration rate [EGFR]60 mL/min) and paired baseline and 30-day measures of renal function undergoing TAVR in the PARTNER 1 trial and continued access registries was conducted in 25 centers in the United States and Canada. MAIN OUTCOMES AND MEASURES Patientswere categorized with improved EGFR (30-day follow-up EGFR10% higher than baseline pre-TAVR), worsened EGFR (10% lower), or no change in renal function (neither). Baseline characteristics, 30-day to 1-year all-cause mortality, and repeat hospitalization were compared. Multivariable models were constructed to identify predictors of 1-year mortality and of improvement/worsening in EGFR. RESULTS Of the 821 participants,401 (48.8%)werewomen and the mean (SD) age for participants with improved, unchanged, orworsening EGFRwas 84.90(6.91) years, 84.37 (7.13) years, and 85.39 (6.40) years, respectively. The EGFRwas 60mL/min or lower among 821 patients (72%), ofwhom345 (42%) improved, 196 (24%)worsened, and 280 (34%) had no change at 30 days. Therewere no differences in baseline age, body mass index, diabetes, chronic obstructive pulmonary disease, coronary artery disease, peripheral arterial disease, hypertension, pulmonary hypertension, renal or liver disease,NewYork Heart Association III/IV symptoms, transaortic gradient, left ventricular ejection fraction, or procedural characteristics. The group with improved EGFR had morewomen, nonsmokers, and a lower cardiac index. Those with worsening EGFR had a higher median Society of Thoracic Surgeons score and left ventricle mass. From 30 days to 1 year, those with improved EGFR had no difference in mortality or repeat hospitalization. Those withworsening EGFR had increased mortality (25.5%vs 19.1%, P = .07) but no significant increases in repeat hospitalization or dialysis. Predictors of improved EGFRwere being female (odds ratio [OR], 1.38; 95%CI, 1.03-1.85; P = .03) and nonsmoking status (OR, 1.49; 95%CI, 1.11-1.01; P = .01); predictors ofworsening EGFRwere baseline left ventricle mass (OR, 1.00; 95%CI, 1.00-1.01; P = .01), smoking (OR, 1.51; 95%CI, 1.06-2.14; P = .02), and age (OR, 1.03; 95%CI, 1.00-1.05; P = .05); and predictors of 1-year mortalitywere baseline left ventricular ejection fraction (OR,0.98; 95%CI,0.97-0.99; P = .003), baseline EGFR (OR,0.98; 95%CI,0.96-0.99; P < .001), andworsening EGFR vs no change in EGFR (OR, 1.51; 95%CI, 1.02-2.24; P = .04). CONCLUSIONS AND RELEVANCE Baseline renal impairment was frequent among patients who underwent TAVR. While improved EGFR did not improve 1-year outcomes, worsening EGFR was associated with increased mortality.

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U2 - 10.1001/jamacardio.2017.1220

DO - 10.1001/jamacardio.2017.1220

M3 - Article

VL - 2

SP - 742

EP - 749

JO - JAMA Cardiology

JF - JAMA Cardiology

SN - 2380-6583

IS - 7

ER -