Early Recovery of Left Ventricular Systolic Function After CoreValve Transcatheter Aortic Valve Replacement Harold L. Dauerman, MD; Michael J. Reardon,

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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

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.

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

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.

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.

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.

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.

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

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.

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

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.

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

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.