Neurological complications after transcatheter aortic valve implantation with a self-expanding bioprosthesis or surgical aortic valve replacement in patients at intermediate-risk for surgery A. Pieter Kappetein, Erasmus Medical Centre, Rotterdam, Netherlands Nicolas M. Van Mieghem, Erasmus Medical Centre, Rotterdam, Netherlands Michael J. Reardon, Methodist Debakey Heart and Vascular Center, Houston, TX, USA Patrick W. J. C. Serruys, Erasmus Medical Centre, Rotterdam, Netherlands Jeffrey J. Popma, Beth Israel Deaconess Medical Center, Boston, MA, USA For the SURTAVI Investigators
Speaker's name: Prof. A Pieter Kappetein I do not have any potential conflict of interest X I have the following potential conflicts of interest to report: Institutional grant/research support: Medtronic Medtronic personnel performed all statistical analyses and verified the accuracy of the data, and assisted in the graphical display of the data presented. 2
Background An increased risk for death, long-term morbidity and poor quality of life is associated with periprocedural stroke after surgical or transcatheter aortic valve implantation (TAVI). The SURTAVI Trial showed that TAVI with a self-expanding CoreValve or Evolut R bioprosthesis was noninferior to surgical aortic valve replacement (SAVR) for all-cause mortality or disabling stroke at 2 years. As TAVI continues to be clinically evaluated in lower-risk populations, an understanding of the relative risk for neurological complications and their clinical consequences following SAVR and TAVI is critical. 3
Methods PATIENTS: Severe, symptomatic aortic stenosis at intermediate surgical risk Risk determined by heart team at each site: Estimated surgical mortality 3% and <15% and other measures of comorbidity, frailty and disability International screening committee confirmed patient eligibility STUDY: Independent Clinical Events Committee adjudicated all neurological events. VARC-2* definitions of stroke Encephalopathy included evidence of altered mental state (e.g. seizures, delirium, confusion, hallucinations, dementia) Neurologist or stroke specialist evaluated patients with suspected event Imaging at discretion of specialist All stroke and encephalopathy were compared between TAVI and SAVR at 30 days. *Kappetein AP, et al. Eur Heart J 2012;33: 2403-18. 4
Neurological assessments NIH Stroke Scale Modified Rankin Score * Mini-Mental State Exam* Additional Assessments* Baseline Post procedure Discharge 30 Days 6 Months 12 Months 18 Months 24 Months 3 5 Years *By neurologist or stroke specialist. Additional testing included; field testing and gait, writing, drawing, and hand function assessments. 5
All stroke (%) Incidence of all stroke 20% TAVI SAVR 15% 10% 5% 30-Day p* = 0.031 5.4 3.3 2-Year p*= 0.143 8.0 6.3 No. at Risk 0% 0 6 12 18 24 Months Post Procedure TAVI 864 731 591 439 263 SAVR 796 653 539 393 230 * log-rank 6
Disabling stroke (%) Incidence of disabling stroke TAVI SAVR 30-Day p* = 0.057 2 Year p* = 0.076 2.4 1.2 4.5 2.4 No. at Risk Months Post Procedure TAVI 864 755 612 456 272 SAVR 796 674 555 407 241 * log-rank 7
Non-disabling stroke (%) Incidence of non-disabling stroke 20% TAVI SAVR 15% 10% 5% 30-Day p* = 0.230 3.0 2.1 2-Year p* = 0.834 4.1 4.0 No. at Risk 0% 0 6 12 18 24 Months Post Procedure TAVI 864 738 600 447 271 SAVR 796 669 553 400 238 * log-rank 8
Timing of early strokes TAVI SAVR Non-disabling Disabling 0 5 10 15 20 25 30 Time from implant to event (days) 9
Percentage of Patients (%) Early stroke severity 100% 90% 80% 70% 60% 50% 40% 30% 20% 10% 0% Modified Rankin Scores at 30 Days 7,1 9,3 42,9 50,0 TAVI N=28 53,4 37,3 SAVR N=43 0 1 2 6 Missing 10I
Mean ± SD or % Baseline data for patients with early stroke TAVI N=28 SAVR N=43 P Value Age, years 78.5 ± 8.2 80.3 ± 6.9 0.32 Male sex 50.0 58.1 0.50 BMI < 21 kg/m 2 3.6 4.7 >0.99 STS Risk of mortality, % 4.4 ± 1.7 4.4 ± 1.6 0.88 EuroSCORE, % 12.6 ± 10.7 11.6 ± 7.6 0.68 NYHA Class 0.20 II 32.1 51.2 III/IV 67.9 48.8 LV ejection fraction, % 59.6 ± 10.7 61.0 ± 10.0 0.57 History of hypertension 96.4 79.1 0.08 Diabetes mellitus 35.7 34.9 0.94 Prior CABG 21.4 16.3 0.58 Peripheral vascular disease 28.6 30.2 0.88 Prior PCI 32.1 25.6 0.55 5-Meter gait speed > 6 sec 53.8 53.5 0.98 Severe aortic calcification 14.3 16.3 >0.99 11
TAVI baseline data: early vs no stroke Mean ± SD or % Stroke N=28 No Stroke N=836 P Value Age, years 78.5 ± 8.2 80.0 ± 6.1 0.35 Male sex 50.0 57.9 0.41 STS Risk of mortality, % 4.4 ± 1.7 4.4 ± 1.5 0.89 History of hypertension 96.4 92.6 0.72 Diabetes mellitus 35.7 34.1 0.86 Peripheral vascular disease 28.6 30.9 0.80 Severe aortic calcification 14.3 12.4 0.77 12
SAVR baseline data: early vs no stroke Mean ± SD or % Stroke N=43 No Stroke N=753 P Value Age, years 80.3 ± 6.9 79.7 ± 6.0 0.54 Male sex 58.1 54.8 0.67 STS Risk of mortality, % 4.4 ± 1.6 4.5 ± 1.6 0.55 History of hypertension 79.1 91.0 0.01 Diabetes mellitus 34.9 34.8 0.99 Peripheral vascular disease 30.2 29.9 0.96 Severe aortic calcification 16.3 10.5 0.23 13
TAVI procedural data: early vs no stroke Mean ± SD, or % Stroke N=28 No Stroke N=836 P Value Delivery catheter in body, min 19.6 ± 17.4 14.9 ± 15.9 0.14 Iliofemoral access, min 92.9 93.7 0.70 Need for revascularization 21.4 19.5 0.80 Procedure time 67.5 ± 43.2 51.8 ± 32.2 0.07 Pre-TAVR balloon valvuloplasty 42.9 47.3 0.64 Post-TAVR balloon valvuloplasty 21.4 29.2 0.37 > 1 Valve implanted 14.3 6.5 0.11 14
SAVR procedural data: early vs no stroke Mean ± SD, or % Stroke N=43 No Stroke N=753 P Value Cardiopulmonary bypass time, min 95.0 ± 34.9 98.0 ± 39.6 0.63 Aortic cross-clamp time, min 72.1 ± 27.6 74.4 ± 30.6 0.63 Total procedure time, min 200.6 ± 63.9 203.9 ± 69.4 0.77 Median or full sternotomy 88.4 89.6 0.88 Concomitant CABG 18.6 22.3 0.57 Concomitant root enlargement 4.7 1.5 0.15 15
TAVI hospitalisation data: early vs no stroke Mean ± SD, or % Stroke N=28 No Stroke N=836 P Value ICU duration, hours 88.0 ± 88.6 47.2 ± 41.1 0.03 Length of stay, days 8.9 ± 5.1 5.6 ± 4.8 <0.001 Discharge Location <0.001 Home 35.7 86.7 Another hospital 3.6 1.2 Rehabilitation clinic 32.1 5.9 Skilled nursing facility 14.3 3.6 Other 3.6 1.4 Patient died in hospital 10.7 1.2 16
SAVR hospitalisation data: early vs no stroke Mean ± SD, or % Stroke N=43 No Stroke N=796 P Value ICU duration, hours 125.3 ± 196.9 67.3 ± 86.3 0.06 Length of stay, days 12.6 ± 7.9 9.6 ± 8.0 0.02 Discharge Location 0.002 Home 27.9 55.8 Another hospital 4.7 3.6 Rehabilitation clinic 41.9 21.1 Skilled nursing facility 11.6 13.4 Other 11.6 4.8 Patient died in hospital 2.3 1.3 17
SF-36 physical summary 50 Quality of life by early vs no stroke 45 40 35 30 25 Série1 Série2 Série3 Série4 1 2 3 Change from baseline, mean ± SD TAVI stroke 4.3 ± 10.6 7.4 ± 9.7 SAVR stroke -2.6 ± 9.5 5.1 ± 9.9 P value for change from baseline 0.01 0.42 TAVI no stroke 5.8 ± 10.4 6.4 ± 10.3 SAVR no stroke -1.0 ± 11.1 6.4 ± 10.4 P value for change from baseline <0.001 0.99 18
All-cause mortality (%) Mortality in patients with early stroke No. at Risk TAVI 28 22 18 SAVR 43 34 28 19
All-cause mortality (%) Mortality in patients with early encephalopathy No. at Risk TAVI 14 12 9 SAVR 62 52 45 20
Subgroup analyses for early stroke Subgroup TAVI SAVR Hazard Ratios (95% CI) P for Interaction n/n (KM rate at 30 Days) Age 0.95 < 80 Years 12/352 (3.4) 19/330 (5.8) 0.59 (0.28 to 1.21) 80 Years 16/512 (3.1) 24/466 (5.2) 0.61 (0.32 to 1.14) Sex 0.37 Male 14/498 (2.8) 25/438 (5.7) 0.49 (0.25 to 0.94) Female 14/366 (3.9) 18/ 358 (5.1) 0.76 (0.38 to 1.53) STS 0.90 <4% 10/345 (2.9) 15/299 (5.0) 0.58 (0.26 to 1.28) 4% 18/519 (3.5) 28/497 (5.7) 0.61 (0.34 to 1.11) Diabetes 0.90 No 18/569 (3.2) 28/519 (5.4) 0.58 (0.32 to 1.06) Yes 10/295 (3.4) 15/277 (5.5) 0.62 (0.28 to 1.38) Revascularization Needed 0.52 No 22/695 (3.2) 36/633 (5.7) 0.55 (0.33 to 0.94) Yes 6/169 (3.6) 7/163 (4.3) 0.82 (0.28 to 2.44) Severe AO Calcification 0.60 No 24/756 (3.2) 36/710 (5.1) 0.63 (0.37 to 1.05) Yes 4/108 (3.7) 7/86 (8.2) 0.44 (0.13 to 1.50) PVD 0.81 No 20/598 (3.4) 30/558 (5.4) 0.62 (0.35 to 1.09) Yes 8/266 (3.0) 13/238 (5.5) 0.55 (0.23 to 1.32) 0.125 0.25 0.50 1.00 2.00 Favors TAVI Favors SAVR 21
Summary The incidence of early (30-day) stroke was significantly lower in patients after TAVI than after SAVR. Early stroke patients experienced longer ICU times, more days in hospital and were more frequently discharged to an alternate care facility regardless of treatment group. With or without stroke, TAVI patients recovered quality of life sooner than SAVR patients. All-cause mortality at 1 year was similar for TAVI and SAVR patients with stroke or with encephalopathy at 30 days. There were no differences in early stroke rates among TAVI and SAVR patients for select subgroups. 22