Association Between Early Left Ventricular Ejection Fraction Improvement After Transcatheter Aortic Valve Replacement and 5-Year Clinical Outcomes

Abstract

In patients with severe aortic stenosis and left ventricular ejection fraction (LVEF) less than 50%, early LVEF improvement after transcatheter aortic valve replacement (TAVR) is associated with improved 1-year mortality; however, its association with long-term clinical outcomes is not known.OBJECTIVE To examine the association between early LVEF improvement after TAVR and 5-year outcomes. DESIGN, SETTING, AND PARTICIPANTSThis cohort study analyzed patients enrolled in the Placement of Aortic Transcatheter Valves (PARTNER) 1, 2, and S3 trials and registries between July 2007 and April 2015. High-and intermediate-risk patients with baseline LVEF less than 50% who underwent transfemoral TAVR were included in the current study. Data were analyzed from August 2020 to May 2021.EXPOSURES Early LVEF improvement, defined as increase of 10 percentage points or more at 30 days and also as a continuous variable (ΔLVEF between baseline and 30 days). MAIN OUTCOMES AND MEASURESAll-cause death at 5 years. RESULTS Among 659 included patients with LVEF less than 50%, 468 (71.0%) were male, and the mean (SD) age was 82.4 (7.7) years. LVEF improvement within 30 days following transfemoral TAVR occurred in 216 patients (32.8%) (mean [SD] ΔLVEF, 16.4 [5.7%]). Prior myocardial infarction, diabetes, cancer, higher baseline LVEF, larger left ventricular end-diastolic diameter, and larger aortic valve area were independently associated with lower likelihood of LVEF improvement. Patients with vs without early LVEF improvement after TAVR had lower 5-year all-cause death ( 102[50.0%; 95% CI, 43.3-57.1] vs 246 [58.4%; 95% CI, 53.6-63.2]; P = .04) and cardiac death (52 [29.5%; 95% CI, 23.2-37.1] vs 135 [38.1%; 95% CI,]; P = .05). In multivariable analyses, early improvement in LVEF (modeled as a continuous variable) was associated with lower 5-year all-cause death (adjusted hazard ratio per 5% increase in LVEF, 0.94 [95% CI, 0.88-1.00]; P = .04) and cardiac death (adjusted hazard ratio per 5% increase in LVEF, 0.90 [95% CI, 0.82-0.98]; P = .02) after TAVR. Restricted cubic spline analysis demonstrated a visual inflection point at ΔLVEF of 10% beyond which there was a steep decline in all-cause mortality with increasing degree of LVEF improvement. There were no statistically significant differences in rehospitalization, New York Heart Association functional class, or Kansas City Cardiomyopathy Questionnaire Overall Summary score at 5 years in patients with vs without early LVEF improvement. In subgroup analysis, the association between early LVEF improvement and 5-year all-cause death was consistent regardless of the presence or absence of coronary artery disease or prior myocardial infarction. CONCLUSIONS AND RELEVANCEIn patients with severe aortic stenosis and LVEF less than 50%, 1 in 3 experience LVEF improvement within 1 month after TAVR. Early LVEF improvement is associated with lower 5-year all-cause and cardiac death.

Comparison of Periprocedural and Intermediate-Term Outcomes of TAVI in Patients with Ejection Fraction ≤ 20% vs. Patients with 20% < EF ≤ 40%

“…Prior studies have also showed that in patients with LVEF < 40%, almost half of them experience an improvement in EF by at least 10% within 30 days after TAVR [ 9 , 10 ]. Recently, Dhaval Kolte et al published data on the 5-year all-cause death and cardiac death for a cohort of high- or intermediate-risk patients with severe AS and EF < 50% from the PARTNER trial, showing lower mortality in patients who experienced an improvement in LVEF after TAVR [ 11 ].…”

Transcatheter aortic valve replacement in heart failure

“…LVEF increase ≥5 or ≥10%) following TAVR has been reported in 22-48% of patients with LVSD at 30 days (Figure 1). 7,12,[18][19][20] In the PARTNER I trial, LVEF increased at 30 days and 6 months post-TAVR in patients with pre-existing LVEF <50%, with nearly 35% of patients undergoing transfemoral access and 22% of patients undergoing transapical access experiencing a ≥10% absolute increase in LVEF at 30 days. 12 Predictors of LVEF recovery have included female sex, absence of prior percutaneous coronary intervention (PCI), absence of peripheral vascular disease, lower baseline LVEF, and lower stroke volume index.…”

“…Left ventricular ejection fraction recovery (i.e. LVEF increase ≥5 or ≥10%) following TAVR has been reported in 22–48% of patients with LVSD at 30 days ( Figure ) 7,12,18–20 . In the PARTNER I trial, LVEF increased at 30 days and 6 months post‐TAVR in patients with pre‐existing LVEF <50%, with nearly 35% of patients undergoing transfemoral access and 22% of patients undergoing transapical access experiencing a ≥10% absolute increase in LVEF at 30 days 12 .…”

Letter by Li et al Regarding Article, “Circulating MicroRNA-122-5p Is Associated With a Lack of Improvement in Left Ventricular Function After Transcatheter Aortic Valve Replacement and Regulates Viability of Cardiomyocytes Through Extracellular Vesicles”

“…Furthermore, it is well documented that each improvement of 5% points in LVEF at 30 days was linked to a 6% and 10% lower risk of all-cause and cardiac death at 5 years, respectively, indicating that early LVEF improvement after TAVR was associated with lower 5-year all-cause death and cardiac death. 4 Thus, the prognostic significance of LVEF improvement may be related to reduced mortality in patients after TAVR. These aspects need to be refined further in later clinical research.…”