A shifting paradigm of care: Advances in transcatheter heart valve procedures

1. A shifting paradigm of care: Advances in transcatheter heart valve procedures Sandra Lauck MSN, RN, CCN(C) Clinical Nurse Specialist, Arrhythmia Management and Interventional Cardiology

2. What is available for what valve? • Transcatheter aortic valve implantation • Mitral valve repair • Pulmonary valve implantation • What are the implications for cardiac nurses?

3. Transcatheter approaches • Minimally invasive • No cardiac bypass • Vascular access: • Transfemoral • Transvenous • Transapical • Use of catheters to deliver device or perform repair • No valve replacement – Native annulus remains in place • Imaging requirements: • Fluoroscopy • Echocardiography • Operators: Interventional cardiologists and cardiac surgeons

4. Transcatheter aortic valve implantation Stent valve with bovine pericardial leaflets Delivery flexible and steerable catheter with valvuloplasty balloon Crimped stent valve on delivery balloon catheter

5. TAVI approaches Transfemoral Transapical

6. Transfemoral TAVI • Femoral artery puncture • Steerable catheter • Retrograde approach • Common iliac arteries • Aorta • Aortic root • Into native annulus • Primary operator: Interventional cardiologist

7. Transfemoral TAVI

8. Transapical TAVI • Mini-thoracotomy • Vascular access sheath inserted into apex of LV • Primary operator: Cardiac surgeon

9. Transapical TAVI

10. Hybrid Cath Lab/OR Fluoroscopy Advanced hemodynamic monitoring

11. Hybrid Cath Lab/OR Cardiac surgery bypass capacity Teaching screen Cardiac anaesthesia

12. Evidence supporting TAVI

13. PARTNER A: Inoperable patients Symptomatic Severe Aortic Stenosis ASSESSMENT: High-Risk AVR Candidate 3,105 PatientsScreened Total = 1,057 patients High Risk Inoperable N = 358 N = 699 2 Parallel Trials ASSESSMENT: Transfemoral Access Yes No 1:1 Randomization Not In Study N = 179 N = 179 TF TAVR Standard Therapy VS Primary Endpoint: All-Cause Mortality Superiority

14. PARTNER B: Most patients were over 80 50% Percent of Patients 22% 20% 7% 2% Age (years)

15. Mortality at 30 days and 1 year P = .41 P = .001 Mortality, % THV (n = 179) Standard Therapy (n = 179)

16. Repeat hospitalization P < 0.0001 % P = 0.17 TAVI (n=179) Standard Rx (n=179)

17. “Balloon-expandable TAVI should be the new standard of care for patients with aortic stenosis who are not suitable candidates for surgery”

18. PARTNER A Symptomatic Severe Aortic Stenosis ASSESSMENT: High-Risk AVR Candidate 3,105 Total Patients Screened Total = 1,057 patients Inoperable High Risk N = 358 N = 699 2 Parallel Trials: Individually Powered ASSESSMENT: Transfemoral Access ASSESSMENT: Transfemoral Access Yes No Transapical (TA) Transfemoral (TF) Yes No 1:1 Randomization 1:1 Randomization 1:1 Randomization Not In Study N = 244 N = 248 N = 104 N = 103 N = 179 N = 179 TF TAVR AVR TA TAVR AVR TF TAVR Standard Therapy VS VS VS Primary Endpoint: All-Cause Mortality Superiority Primary Endpoint: All-Cause Mortality at 1 yrNon-inferiority

19. All-cause mortality at 1 year HR [95% CI] =0.93 [0.71, 1.22] P (log rank) = 0.62 0.5 TAVR AVR 0.4 26.8 0.3 24.2 0.2 0.1 0 0 6 12 18 24 No. at Risk Months TAVR AVR

20. Transfemoral AVR • Is superior to medical management in inoperable patients • Is equivalent to surgery in selected, high risk patients even if they are “operable”

21. Improved technology = Improved procedural success

22. Mitral valve repair • Edge to edge repair • Coronary sinus annuloplasty • Mitral valve implantation

23. Edge to edge repair

24. Coronary sinus MV annuloplasty Coronary sinus

25. Mitral valve ‘cinching’

26. Mitral valve implantation

27. Pulmonary valve implantation

28. Implications for cardiac nurses • ‘Hybrid’ procedures • Cath lab nursing • OR nursing • Cardiology and cardiac surgery recovery areas • ‘New’ patient population • Low volume and higher risk • Decision-making support and unique processes of care • Evidence-based inter-disciplinary program development • Same-day discharge?

30. Thank you slauck@providencehealth.bc.ca