For the SURTAVI Investigators

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Spencer Cameron
5 years ago
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1 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

2 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

3 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

4 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:

5 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

6 All stroke (%) Incidence of all stroke 20% TAVI SAVR 15% 10% 5% 30-Day p* = Year p*= No. at Risk 0% Months Post Procedure TAVI SAVR * log-rank 6

Disabling stroke (%) Incidence of disabling stroke TAVI SAVR 30-Day p* = 0.057 2 Year p* = 0.076 2.4 1.

7 Disabling stroke (%) Incidence of disabling stroke TAVI SAVR 30-Day p* = Year p* = No. at Risk Months Post Procedure TAVI SAVR * log-rank 7

8 Non-disabling stroke (%) Incidence of non-disabling stroke 20% TAVI SAVR 15% 10% 5% 30-Day p* = Year p* = No. at Risk 0% Months Post Procedure TAVI SAVR * log-rank 8

9 Timing of early strokes TAVI SAVR Non-disabling Disabling Time from implant to event (days) 9

10 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= Missing 10I

11 Mean ± SD or % Baseline data for patients with early stroke TAVI N=28 SAVR N=43 P Value Age, years 78.5 ± ± Male sex BMI < 21 kg/m >0.99 STS Risk of mortality, % 4.4 ± ± EuroSCORE, % 12.6 ± ± NYHA Class 0.20 II III/IV LV ejection fraction, % 59.6 ± ± History of hypertension Diabetes mellitus Prior CABG Peripheral vascular disease Prior PCI Meter gait speed > 6 sec Severe aortic calcification >

12 TAVI baseline data: early vs no stroke Mean ± SD or % Stroke N=28 No Stroke N=836 P Value Age, years 78.5 ± ± Male sex STS Risk of mortality, % 4.4 ± ± History of hypertension Diabetes mellitus Peripheral vascular disease Severe aortic calcification

13 SAVR baseline data: early vs no stroke Mean ± SD or % Stroke N=43 No Stroke N=753 P Value Age, years 80.3 ± ± Male sex STS Risk of mortality, % 4.4 ± ± History of hypertension Diabetes mellitus Peripheral vascular disease Severe aortic calcification

14 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 ± ± Iliofemoral access, min Need for revascularization Procedure time 67.5 ± ± Pre-TAVR balloon valvuloplasty Post-TAVR balloon valvuloplasty > 1 Valve implanted

15 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 ± ± Aortic cross-clamp time, min 72.1 ± ± Total procedure time, min ± ± Median or full sternotomy Concomitant CABG Concomitant root enlargement

16 TAVI hospitalisation data: early vs no stroke Mean ± SD, or % Stroke N=28 No Stroke N=836 P Value ICU duration, hours 88.0 ± ± Length of stay, days 8.9 ± ± 4.8 <0.001 Discharge Location <0.001 Home Another hospital Rehabilitation clinic Skilled nursing facility Other Patient died in hospital

17 SAVR hospitalisation data: early vs no stroke Mean ± SD, or % Stroke N=43 No Stroke N=796 P Value ICU duration, hours ± ± Length of stay, days 12.6 ± ± Discharge Location Home Another hospital Rehabilitation clinic Skilled nursing facility Other Patient died in hospital

18 SF-36 physical summary 50 Quality of life by early vs no stroke Série1 Série2 Série3 Série Change from baseline, mean ± SD TAVI stroke 4.3 ± ± 9.7 SAVR stroke -2.6 ± ± 9.9 P value for change from baseline TAVI no stroke 5.8 ± ± 10.3 SAVR no stroke -1.0 ± ± 10.4 P value for change from baseline <

19 All-cause mortality (%) Mortality in patients with early stroke No. at Risk TAVI SAVR

20 All-cause mortality (%) Mortality in patients with early encephalopathy No. at Risk TAVI SAVR

21 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) Favors TAVI Favors SAVR 21

22 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

Transcatheter Aortic Valve Replacement with a Self-Expanding Prosthesis or Surgical Aortic Valve Replacement in Intermediate-Risk Patients:

Transcatheter Aortic Valve Replacement with a Self-Expanding Prosthesis or Surgical Aortic Valve Replacement in Intermediate-Risk Patients: 1-Year Results from the SURTAVI Clinical Trial Nicolas M. Van