The Impact of Prior Stroke on the Outcome of Patients with Severe Aortic Stenosis Undergoing Transcatheter Aortic Valve Replacement Romain Didier, MD; Edward Koifman, MD; Sarkis Kiramijyan, MD; SmitaI.Negi, MD; Ricardo O. Escarcega, MD; Nevin C. Baker, DO; Jiaxing Gai, MSPH; Rebecca Torguson, MPH; Petros Okubagzi, MD; Itsik Ben-Dor, MD; Lowell F. Satler, MD; Augusto D. Pichard, MD; Ron Waksman, MD MedStar Washington Hospital Center, Washington, DC

Romain DIDIER, MD The Impact of Prior Stroke on the Outcome of Patients with Severe Aortic Stenosis Undergoing Transcatheter Aortic Valve Replacement FINANCIAL DISCLOSURE: No relevant financial relationship exists Presenter Disclosure Information Elements

Patients undergoing Transcatheter valve replacement (TAVR) with prior stroke may be at higher risk compared to the patients without prior stroke due to hemodynamic instability coagulation issues and impaired neurological reserve. A history of a prior stroke in patients undergoing Surgical Aortic Valve Replacement has been identified as an independent risk factor for post-procedural stroke. However, there are scarce data regarding incidence of post-procedural stroke and mortality in patients with prior stroke undergoing TAVR. Background

The present study aimed to evaluate the impact of prior Cerebro- vascular events in patients undergoing TAVR in regard to in- hospital outcomes and early and late mortality. Aims

Patients with severe aortic stenosis undergoing TAVR between May 2007 and March 2015 from the Washington Hospital Center were included and categorized to patients with and without prior stroke, defined as embolic, hemorrhagic stroke and transit ischemic attack. Baseline, procedural characteristics and in-hospital outcomes in accordance with the Valve Academic Research Consortium-2 consensus were prospectively collected during the screening, on admission, immediately post-procedure, and during follow-up. The 1-month and 1-year mortality were compared between the two groups. All patients with stroke had neurological evaluation and neuroimaging documentation (brain computer tomography or brain magnetic resonance imaging) Methods

Baseline characteristics No Prior Stroke (N=543) Prior Stroke (N=120) p Age, years, sd 83 ± ± BMI, sd ± ± NYHA class III or IV 90% (475)85.7% (102)0.18 Cardiovascular risk factor Hypertension 93.2% (506)95% (114)0.46 Diabetes 33.1% (179)34.2% (41)0.98 Insulin dependent diabetes 10.9% (59)10.8% (13)0.98 Hyperlipidemia 79.1% (427)84.9% (101)0.15 Current or prior smoking 33.6% (159)31.4% (33)0.66 Past medical history COPD 36.4% (197)27.5% (33)0.06 Renal insufficiency 43.8% (235)59% (69)0.003 History of cancer 26.2% (121)21.7% (20)0.36 Carotid artery disease 12.3% (56)67.8% (61)<0.001 Peripheral vascular disease 32.5% (171)42.9% (51)0.03 History of CAD 72.4% (323)83.8% (83)0.02 Prior CABG 31.7% (171)45% (54)0.005 Prior PCI 31.5% (169)26.9% (32)0.32 Prior MI 18.4% (97)20.2% (24)0.65 Prior valve surgery 4.9% (23)3.3% (3)0.78 Prior BAV 27.5% (135)37.8% (37)0.04 Multiple prior BAV 2.9% (13)12.8% (11)<0.001

Baseline characteristics No Prior Stroke (N=543)Prior Stroke (N=120)p Baseline rhythm History of Atrial fibrillation / Flutter 43.2% (234)35.8% (43)0.14 Pacemaker 25.1% (94)22% (20)0.54 Baseline ECG sinus rhythm 61.7% (255)66.3% (55)0.44 Baseline ECG Atrial fibrillation 19.7% (81)13.6% (11)0.2 Baseline antiplatelet and anticoagulation treatment Aspirin 83.3% (229)94.5% (69)0.02 Clopidogrel 46.9% (84)58.2 (32)0.14 Warfarin 37.6% (65)32% (16)0.47 Porcelain Aorta 7.2% (39)8.3% (10)0.66 Frailty 43% (101)47.2% (25)0.57 STS Score STS Score >8 52.2% (283)64.7% (77)0.013 STS Score, sd 8.8 ± ± Logistic Euro Score, sd 25.2 ± ± 27.8<0.001

Baseline cardiac computed tomography angiography, echocardiography, and catheterization. No Prior Stroke (N=543)Prior Stroke (N=120)p Cardiac CTA indices Severe ascending aorta calcification25.1% (74)41.5% (22)0.01 Severe aortic valve calcification39.1% (117)48.2% (27)0.2 Aortic valve area, mm 2, sd453.6 ± ± MLD right side, mm 2, sd 7.28 ± ± MLD left side, mm 2, sd 7.24 ± ± Echocardiographic indices LVEF, %, sd52.2 ± ± LVSDD, sd4.47 ± ± LVSSD, sd3.09 ± 0.93 ± LA diameter, sd4.53 ± ± AVA, cm 2, sd0.67 ± ± AVA Indexed, cm 2 /m 2, sd 1.85 ± ± Aortic Valve Max Velocity, m/s, sd 4.3 ± ± Mean Gradient, mmHg, sd47.3 ± ± Severe MR0.4% (2)1% (1)0.4 Severe RV dysfunction2.9% (14)1.9% (2)0.7 PASP, mmHg, sd45.5 ± ± Catheterization indices Three vessel disease (>50%)18.2% (62)31.7% (20)0.01 LAD >50% stenosis38.5% (134)59.4% (38)0.002

No Prior Stroke (N=543) Prior Stroke (N=120) p Anesthesia Conscious sedation71% (385)65% (78)0.19 General anesthesia29.5% (160)35.8% (43)0.17 Access Transfemoral access79.6% (432)70.8% (85)0.037 Transapical access17.3% (94)27.5% (33)0.01 Procedure Pre-TAVR BAV87.6% (475)84.7% (100)0.4 Rapid pacing97.8% (528)96.6% (114)0.5 Hypotension7% (38)7.5% (9)0.85 Post-TAVR balloon8.3% (39)3.8% (3.8)0.11 Intra-aortic balloon pump1.7% (5)2.5% (2)0.64 One valve deployed94.7% (514)94.2% (113)0.82 Type of valve Edwards Sapien Valve47.5% (261)57.3% (67)0.06 Edwards XT Valve20% (110)23.1% (27)0.46 Core Valve23.7% (130)16.2% (19)0.08 Procedural parameters

Mortality 18,3% 15,6% 22.5% 21.7% No prior stroke Prior stroke % 7.6%

In-hospital outcomes

No prior stroke (N=543)Prior stroke (N=120)p VARC-2 major vascular complications 10.5% (55)9.3% (11)0.7 VARC-2 life-threatening bleeding 7.5% (40)9.2% (11)0.5 New pacemaker implantation 8.4% (44)4.2% (5)0.12 New atrial fibrillation/flutter 13% (69)15.1% (18)0.54 Post-procedure hospital stay, median, IQR 5 ± 46 ± Post-procedure ICU stay, median, IQR 2 ± Bleeding and Hospital stay

This study supports the hypothesis that TAVR in patients with a history of stroke is safe. Although it is accompanied by higher rate of in-hospital minor stroke and acute kidney injury, it confers no impact on early or late mortality and even hospitalization length. Accordingly, patients with prior stroke should be not excluded from TAVR procedures due to this condition alone. Nevertheless, patients with prior stroke are at higher risk of and may require more care before, during and after the procedure. Conclusions