1. Early Recovery of Left Ventricular Systolic Function After CoreValve Transcatheter Aortic Valve Replacement
Harold L. Dauerman, MD; Michael J. Reardon, MD; Jeffrey J. Popma, MD; Stephen H. Little, MD; João L. Cavalcante, MD; David H. Adams, MD; Neil S. Kleiman, MD; Jae K. Oh, MD; For the CoreValve Investigators 

2. Background
Approximately one third of patients with symptomatic aortic stenosis have reduced left ventricular (LV) ejection fraction (EF) before transcatheter aortic valve replacement (TAVR).
The incidence, predictors and significance of early LVEF recovery after CoreValve TAVR have not been described.

3. Methods
We studied 156 patients from the CoreValve Extreme and High Risk trials with LVEF ≤40% at baseline.
All patients underwent core lab echocardiographic assessment of LVEF at baseline, postprocedure, discharge, 30 days, 6 months, and 1 year.
Early LVEF recovery was defined as an absolute increase of ≥10% in EF at 30 days.
One-year outcomes were compared between patients with and without early recovery.
Multivariable analysis was performed to determine independent predictors of early recovery

4. Baseline Clinical Characteristics
No LV Recovery (N=59)
LV Recovery (N=97)
p-value
Age (years)
82.0 ± 9.2 (59)
83.0 ± 9.0 (97)
0.50
Female
25.4% (15/59)
33.0% (32/97)
0.32
Diabetes mellitus
49.2% (29/59)
38.1% (37/97)
0.18
Hypertension
94.9% (56/59)
85.6% (83/97)
0.11
History of smoking
66.1% (39/59)
55.7% (54/97)
0.20
Hyperlipidemia
84.7% (50/59)
86.6% (84/97)
0.75
Prior MI
59.3% (35/59)
44.3% (43/97)
0.07
Prior PCI
39.0% (23/59)
41.2% (40/97)
0.78
Multi vessel CAD
89.8% (53/59)
88.7% (86/97)
0.82
NYHA Class < IV
62.7% (37/59)
68.0% (66/97)
NYHA Class IV
37.3% (22/59)
32.0% (31/97)
Creatinine Level >2 mg/dl
6.8% (4/59)
6.2% (6/97)
> 0.99
Chronic Kidney Disease (4/5)
13.8% (8/58)
15.6% (15/96)
0.76
Prior stroke or TIA
27.1% (16/59)
20.6% (20/97)
0.35
Chronic Lung Disease/COPD
55.9% (33/59)
66.0% (64/97)
0.21
Home Oxygen
25.8% (25/97)
0.96
Prior CABG
57.6% (34/59)
53.6% (52/97)
0.62
Peripheral vascular disease
50.8% (30/59)
35.1% (34/97)
0.05
LV Recovery defined as ≥10% absolute improvement in EF at 30 days compared to baseline.

5. Baseline Echo Characteristics
No LV Recovery (N=59)
LV Recovery (N=97)
p-value
EF (%)
32.9 ± 6.2 (59)
31.8 ± 7.5 (97)
0.32
Mean Gradient (mmHg)
34.5 ± 9.5 (58)
42.3 ± 14.0 (96)
< 0.001
Peak aortic valve velocity(M/sec)
3.7 ± 0.5 (58)
4.1 ± 0.6 (96)
0.001
Aortic valve area (cm2)
0.8 ± 0.2 (49)
0.7 ± 0.3 (83)
0.08
Mitral deceleration time (ms)
174.6 ± 54.0 (40)
177.3 ± 61.7 (73)
0.82
Stroke Volume Index (mL/m2)
35.1 ± 10.0 (49)
35.0 ± 9.5 (83)
0.95
LVES Dimension (cm)
4.6 ± 0.5 (51)
4.4 ± 0.6 (78)
0.10
Moderate/Severe MR
15.5% (9/58)
28.4% (27/95)
0.07
Moderate/Severe Pulmonary HTN
11.9% (5/42)
17.4% (12/69)
0.44
Right Ventricular Dysfunction
45.5% (25/55)
47.3% (44/93)
0.83
LV Recovery defined as ≥10% absolute improvement in EF at 30 days compared to baseline.

6. Procedural Characteristics
No LV Recovery (N=59)
LV Recovery (N=97)
p-value
Transfemoral
76.3% (45/59)
73.2% (71/97)
0.67
Non-femoral
23.7% (14/59)
26.8% (26/97)
Mild PVL
72.4% (42/58)
72.5% (66/91)
0.99
Moderate PVL
5.2% (3/58)
5.5% (5/91)
> 0.99
Severe PVL
0.0% (0/58)
0.0% (0/91) NA
Valve size (mm) 23
0.0% (0/59)
0.0% (0/97)
0.76 26
20.3% (12/59)
22.7% (22/97) 29
71.2% (42/59)
69.1% (67/97) 31
8.5% (5/59)
8.2% (8/97)
Pacemaker requirement post TAVR
37.9% (11/29)
24.1% (14/58)
0.18
LV Recovery defined as ≥10% absolute improvement in EF at 30 days compared to baseline.

7. Time Course of LV Recovery Changes in LV Systolic Function Over Time
Characteristic
No LV Recovery (N=59)
LV Recovery (N=97)
p-value
EF(%)
Baseline
32.9 ± 6.2 (59)
31.8 ± 7.5 (97)
0.32
Discharge
38.9 ± 11.5 (56)
46.6 ± 11.6 (95)
0.001
Δ baseline to Discharge
6.0 ± 10.8 (56)
15.0 ± 10.1 (95)
< 0.001
1 Month
31.5 ± 6.9 (59)
48.9 ± 8.8 (97)
Δ baseline to 1 Month
-1.4 ± 6.9 (59)
17.1 ± 7.3 (97)
6 Months
39.0 ± 9.4 (44)
48.6 ± 11.3 (82)
Δ baseline to 6 Months
6.0 ± 11.3 (44)
16.5 ± 12.6 (82)
1 Year
43.3 ± 12.3 (41)
49.0 ± 11.5 (76)
0.01
Δ baseline to 1 Year
10.2 ± 13.3 (41)
17.2 ± 13.5 (76)
0.009
LV Recovery defined as ≥10% absolute improvement in EF at 30 days compared to baseline.

8. Time Course of LV Recovery
2/3 of Patients Demonstrate Recovery in First 48 Hours After TAVR

9. One Year Clinical Outcomes
Characteristic
No LV Recovery (N=59)
LV Recovery (N=97)
p-value
All-Cause Mortality
23.7% (14)
12.4% (12)
0.07
Cardiovascular Mortality
12.4% (7)
10.4% (10)
0.72
Aortic Valve Hospitalization
38.4% (21)
22.0% (21)
0.08
Major Bleed
30.8% (18)
38.3% (37)
0.31
All Stroke
6.8% (4)
6.4% (6)
0.83
NYHA Class IV
0.0% (0/41)
0.0% (0/79) NA
KCCQ Overall Summary Score Δ from baseline
28.4 ± 30.7 (33)
21.8 ± 32.1 (69)
0.33
LV Recovery defined as 10% absolute improvement in EF at 30 days compared to baseline.

10. All-cause Mortality P (log-rank) = 0.07 23.7% 11.9% 12.4% 9.3% 1.0%
0.0%
No. at risk: 59 52 45 97 96 88 85

11. Baseline Mean Gradient Predicts LV Recovery
Baseline variables were entered into a univariable and stepwise multivariable analysis. Of these, the following were significant at P < 0.10 in the univariable analysis and were entered into the multivariable model:
History of hypertension (OR: 0.32 [0.09,1.16], P = 0.08)
Previous MI (OR: 0.55 [0.28, 1.05], P = 0.07)
Peripheral vascular disease (OR: 0.52 [0.27, 1.01], P = 0.05)
Baseline mean gradient > 40 mmHg (OR: 3.28 [1.59, 6.75], P = 0.001)
Baseline moderate/severe MR (OR: 2.16 [0.93, 5.00], P = 0.07)
Baseline peak aortic valve velocity (OR: 2.59 [1.43, 4.69], P = 0.002)
Baseline aortic valve area (OR: 0.29 [0.07, 1.16], P = 0.08)
Baseline LVES dimension (OR: 0.60, [0.33, 1.10], P = 0.10)
In the multivariable model, only previous MI (OR: 0.44 [0.19, 1.03], P = 0.06) and baseline mean gradient > 40mmHg (OR: 4.59 [1.76, 12.00], P = 0.002) were significant at P < 0.10.

12. LV Recovery at 1 Month (Yes/No)
P =0.001 for comparison of mean gradient between LV Recovery and No Recovery Groups

13. Summary and Conclusions
Nearly two thirds of patients with reduced LVEF will have a marked early improvement after CoreValve TAVR.
Early LVEF recovery is most likely among patients with higher baseline aortic valve gradients and no prior myocardial infarction.