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 Crimped stent valve on delivery balloon catheter Stent valve with bovine pericardial leaflets Delivery flexible and steerable catheter with valvuloplasty balloon

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 Cardiac anaesthesia Teaching screen

12. Evidence supporting TAVI

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

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

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

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

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

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

19. 0 0.1 0.2 0.3 0.4 0.5 06121824 TAVR AVR Months 34829826014767 35125223613965 No. at Risk TAVR AVR 26.8 24.2 All-cause mortality at 1 year HR [95% CI] = 0.93 [0.71, 1.22] P (log rank) = 0.62

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