RESULTS
Our study population included 272 patients: 140 (51%) were men, and 132
(49%) were female. The average patient age was 85.6 ± 7.8 years. Most
of the patients were Caucasian: 259 (95%) Caucasian vs. 8 (3%) Black
vs. 3 (1%) American Indian vs. 2 (1%) Other. The average patient BMI
was 28.2 ± 6. The majority of patients received the newer generation
SAPIEN 3 valve: 14% SAPIEN vs 14% SAPIEN XT vs 56% SAPIEN 3 vs 5%
CoreValve vs 8% CoreValve Evolut vs 3% Evolut Pro. A majority of the
patients had hypertension, hyperlipidemia, and a smoking history: 246
(90%) HTN vs. 203 (75%) HLD vs. 145 (53%) smokers. 95 (35%) patients
had diabetes mellitus type II. 59% of this sample did not have coronary
revascularization procedures before TAVR. Average left ventricular
ejection fraction, aortic valve area, mean gradient, and peak gradient
before TAVR were as follows: 55 ± 13.3, 0.68 ± 0.21, 42.1 ± 16.7, and
67.3 ± 26.8. 70% of the sample had some degree of aortic insufficiency
before TAVR. (Table 1).
Following TAVR, ejection fraction (p<0.001) as well as aortic
valve effective orifice area (p<0.001) increased while both
mean transvalvular (p<0.001) and peak transvalvular gradients
(p<0.001) decreased. The ejection fraction increased by 3.5
percent, and the aortic valve effective orifice area increased by 1.25
cm squared. The mean transvalvular gradient decreased by 33.6 mmHg, and
the peak transvalvular gradient decreased by 49.7 mmHg. (Table 2).
In receiver-operator curve (ROC) analysis, we determined the ELI cutoff
value to be 1.34 (p<0.001), using all-cause mortality as the
primary outcome. (Figure 1). Multivariate cox regression showed an
increased cumulative survival time for nine years post-TAVR in patients
with ELI > 1.34 (p=0.002). (Figure 2). All patients were
assigned to one of two groups based on their calculated ELI.
Patient characteristics are shown in Table 3. One hundred and
seventy-three patients had ELI > 1.34, and ninety-nine
patients had ELI ≤ 1.34. There was no significant difference between
both ELI groups in the following demographic and comorbid conditions:
gender, race, age, BMI, hypertension, diabetes mellitus, hyperlipidemia,
or smoking status. Additionally, there was no significant difference in
prior coronary revascularization, aortic valve area, mean transvalvular
gradient, peak transvalvular gradient, and left ventricular ejection
fraction before TAVR between both ELI groups. 86 (61%) men compared to
87 (66%) women had elevated ELI > 1.34. Patients with ELI
> 1.34 were 82.6 ± 8.2 years, while those with ELI ≤ 1.34
were 82.1 ± 6.5 years (p=0.634). BMI was 27.7 ± 6.1 in patients with ELI
> 1.34 compared to 28.9 ± 5.7 for patients with low ELI (p
= 0.055). Patients with ELI > 1.34 had ejection fraction of
55.8 ± 14.2 while patients with ELI ≤ 1.34 had ejection fraction of 53.5
± 13.1 (p=0.09). SAPIEN valves were most commonly associated with ELI ≤
1.34 (p=0.014): 62% of SAPIEN vs 35% of SAPIEN XT vs 29% of SAPIEN 3
vs 46% of CoreValve vs 35% CoreValve Evolut vs 44% CoreValve Evolut
Pro (Table 3).
All-cause mortality was higher in patients with lower ELI (95%
confidence interval, 5.59 (3.25 - 9.62); p< 0.001). Patients
with ELI ≤ 1.34 had a fivefold increased risk of death following TAVR.
71 (71.7%) patients with ELI ≤ 1.34 compared to 53 (31.2%) patients
with ELI > 1.34 were deceased within nine years following
TAVR. There was no significant difference between ELI groups in the
following clinical outcomes following TAVR: cerebrovascular events,
congestive heart failure, prosthetic thrombosis, bacterial endocarditis,
prosthetic regurgitation, myocardial infarction, new onset dysrhythmias,
cardiac arrest requiring CPR, post-TAVR coronary intervention, TAVR
revision or hospital readmission. (Table 4).
In total, one hundred and twenty-five patients died within nine years
post-TAVR. Univariate analysis was performed on demographic and
patient-related factors that may contribute to death following TAVR.
Hypertension was associated with increased mortality in this univariate
analysis (95% confidence interval, 3.12 (1.21 - 8.03); p=0.021). While
48.4% of all patients had hypertension, 95.2% of deceased patients had
hypertension. Each valve type was associated with different mortality
rates within 9 years post-TAVR (p=0.027): 64.8% SAPIEN vs 53.3%
CoreValve vs 51.7% SAPIEN XT vs 37.9% SAPIEN 3. Although not
statistically significant, age and aortic valve area were other factors
that were borderline. The age of the deceased patients was 83.3 ± 6.8
(95% confidence interval, 1.02 (0.99 - 1.06); p =0.07). The aortic
valve area of the deceased patients was 0.70 ± 0.19 (95% confidence
interval, 1.96 (0.88 - 4.34); p=0.098). The following factors were not
associated with mortality post-TAVR: gender, race, BMI, diabetes
mellitus, hyperlipidemia, smoking status, prior coronary
revascularization, moderate/severe aortic insufficiency, mean
transaortic gradient or left ventricular ejection fraction. (Table
5).
Multivariate Cox regression was performed on select variables with p
values < 0.15. Increased age (hazard ratio, 1.037; 95%
confidence interval 1.006 - 1.069, p=0.019), ELI <1.34 (hazard
ratio, 1.783; 95% confidence interval 1.231 - 2.583, p=0.002) and
SAPIEN valve (hazard ratio, 1.861; 95% confidence interval 1.025 -
3.382, p=0.041) were associated with increased mortality within 9 years
after TAVR. Patients with ELI ≤ 1.34 had a 78% chance of all-cause
mortality following TAVR. Unlike the univariate analysis, the following
variables no longer were associated with mortality: hypertension
(p=0.188), CoreValve (p=0.301), or SAPIEN XT (p=0.813). Although not
statistically significant, the preoperative aortic valve area remained
borderline (hazard ratio, 2.387; 95% confidence interval 0.961 - 5.931,
p=0.061). (Table 6).