Best Clinical P ractice, Research and D evelopment after TAVI

1. Best Clinical Practice, Research and Development after TAVI Sandra LauckPhD, RN Clinical Nurse Specialist Transcatheter Heart Valve Program St. Paul’s Hospital, Vancouver, Canada Clinical Assistant Professor School of Nursing University of British Columbia

2. Best practices and research for TAVI? • Understanding our patients • Building a Heart Team • Developing a clinical pathway

3. Best practices?Understanding our patients

4. Our patients: The devastating effects of severe aortic stenosis Calcium deposits Thickening of valve leaflets  Obstruction of left ventricular outflow LV afterload  LV wall thickness Diastolic dysfunction Concentric hypertrophy Angina • Coronary blood flow • Cardiac output Symptoms of CHF Syncope Heart failure Severe fatigue

5. Survival Percent Onset of severe symptoms 100 Latent Period ( obstruction, myocardial overload) Angina 80 Syncope Failure 2 4 6 0 60 Avg. survivalYears 40 20 Age 0 Our patients

6. Our patients: The elderly Osnabrugge et al., JACC 2013 Nkomo et al., The Lancet 2003

7. Mortality of severe AS • 5-Year Survival8 Survival, % Breast Cancer Lung Cancer Colorectal Cancer Prostate Cancer Ovarian Cancer Severe Inoperable AS* *Using constant hazard ratio. Data on file, Edwards Lifesciences LLC. Analysis courtesy of Murat Tuczu, MD, Cleveland Clinic

8. Our patients Frailty Health function Comorbidities Quality of life Disability Expectations Motivations

9. Best practices to manage risks

10. Consenting for TAVI: Risks and benefits? Mortality Stroke Bleeding Myocardial Infarction Acute Kidney Injury Vascular Complications Conduction Disturbances Valvular Function

11. “I can prove it or disprove it! What do you want me to do?”

12. Current indications

13. Consenting for TAVI: Risks and benefits? Mortality Stroke Bleeding Myocardial Infarction Clinician- reported outcomes Acute Kidney Injury Vascular Complications Conduction Disturbances Valvular Function Satisfaction with care? Quality of life? Change in symptoms? Met expectations? Patient- reported outcomes Motivation? Work/ Caregiving? Availability of social support? Cost and financial burden? Barriers? Facilitators?

14. NYHA I/II at baseline and after TAVI Can J Card, 2013

16. Case selection based on current indications Free of malignancy? Free of dementia? Able to mobilize? Likely to recover easily? Not too frail? Motivated? Access to social support? Likely to return home? Likely to survive > 2 year? STS LogEuro-Score COPD TIA/Stroke Renal impairment Previous surgery Radiation to chest Frailty

17. Likelihood to derive benefit? • Instrumental Activities of Daily Living • Basic Activities of Daily Living • 5-Metre Gait Speed • Mini Mental State Examination • Edmonton Symptom Assessment • Kansas City Cardiomyopathy Questionnaire • Frailty scale • Patient picture • Social situation • Home environment • Home support • History of falls

18. Gait speed Slow walkers 2-3 x ↑ risk of mortality or morbidity Fast walkers

19. Columbia Frailty Score Grip strength Gait speed Activities of Daily Living Serum albumin Less frail More frail Green, JACC 2012

20. Influencing Factors for Assessment for TAVI (IF-TAVI)

21. Experienced and knowledgeable patients “Can you imagine having your chest cut right open? I’ve had about six surgeries in the last six, seven years and I’m still recovering from pretty much all of them”

22. Symptom burden • “I’m just run out of breath and if I try to force it and keep on going, my chest gets sore” • “I walked three and a half miles a day for 22 years, and then I had to stop once, then stop twice. Then I’ve got down, so I couldn’t walk at all” • “I’ve quit that in the last probably 3-4 months because I just couldn’t keep up with them. They’d go and I said , “Well, I’ll go half way,” and they still got back before I did, so I said, “I’ll quit because it just hinders you guys”

23. Expectations • “Well, I'm hoping to gain from my surgery is I want to get back to normal life a little bit. Right now I go to do something, and I just start to do it, and I run out of breath, and my chest gets sore, so I sit down, and that's it. I never get it done” • “I'd like to get something done because I'd like to live a little longer…… another 10 years if I could”. • “it just means that health-wise I'll be able to stay in this world a little longer. And that would be very nice, you know, to watch my grandchildren maybe get married or something like that….”

24. Understanding our patients:Research to support best practices • What are patients’ motivations and expectations? • How do we measure patients’ experience of living with severe AS? • How can we best measure patients’ likelihood to derive significant benefit? • What are patients’ perspective on “Utility” and “Futility”? Is it different from clinicians? • What are patients and their families’ education and discharge planning needs? • Does functional status/frailty predict eligibility for TAVI?

25. Best practices?The TAVI Heart Team

27. Interventional Cardiology Cardiac Surgery

29. CNS TAVI Nurse and Clinic Interventional Cardiology Cardiac Surgery Imaging Echocardiology CT Radiology

30. Beyond case selection… • Diagnostic assessment • Pre-assessment clinic • Consultation services • Pre-procedure conditioning • Patient and referring physician communication • Procedure planning • Emergency intervention planning • Management of complex cases • Admission process • In-patient transfer process • Critical care requirements and standardized orders • Discharge planning • Transition home • Follow-up • Funding model • Outcome evaluation • Communication with senior leadership

31. Pre-procedure Heart Team CNS TAVI Nurse and Clinic Interventional Cardiology Cardiac Surgery Imaging Echocardiology CT Radiology Geriatric Medicine Palliative Care

32. Peri-procedure Heart Team CNS TAVI Nurse and Clinic Interventional Cardiology Cardiac Surgery Imaging Echocardiology CT Radiology Cardiac anaesthesiology Pre-admission clinic Operating Room Cath Lab Perfusion services

33. Post-procedure Heart Team CNS TAVI Nurse and Clinic Interventional Cardiology Cardiac Surgery Imaging Echocardiology CT Radiology Cardiac anaesthesiology Critical care nursing and medicine Discharge planning team

34. The “real” TAVI Heart Team Echocardiography Cardiac Radiology Cardiac Anaesthesia Out-Patient Services Pre-Assessment Clinic Cardiac Cath Lab Operating Room Vascular Surgery Critical Care Pharmacy Physiotherapy Social Work Geriatric Medicine Palliative Care Services Hospital Administration Funding Organizations Medical Director Interventional Cardiologists Cardiac Surgeons Imaging Nursing Nurse Coordinator Clinical Nurse Specialist Nurse Practitioner Administration TAVI ‘Champion’ Team TAVI ‘Core’ Team TAVI ‘Support’ Team

35. Recommendations for building a sustainable Heart Team • Goals: • Role clarity • Optimal resource utilization • Communication • Standardization of practice • Quality assurance • Patient-centred processes of care • Program cost-containment

36. Recommendation #1: Invest time in program development • Medical director • Selection and professional development of TAVI Nurses • Team meetings: • Case selection • Operations and practice • Quality assurance and program evaluation • “Stakeholder engagement” • Referral base • Senior administration • Other medical disciplines

37. Recommendation #2:Develop and support the role of TAVI Nurses • Full member of the TAVI Team • “Face” of the program • Professional growth and development • Skill set required: • Patient and family communication and teaching • Cardiac and geriatric assessment skills • Team communication (including referring MDs) • Clinical triage • Logistics and organization • Role and responsibilities: • Clinical coordination (referral, procedure planning, discharge and follow-up) • Assessment of functional status • Support for procedure planning and other logistics • Education and discharge planning • Organization of the TAVI clinic

38. Managing the TAVI Nurses’ workload Patient and Family Education Waitlist Management Case Selection Patient Assessment Clinical Triage Procedure Logistics Diagnostic Work-Up Coordination ‘Heart Team’ Member Data Collection Program Set-Up Support for Research Communication With Referral Base Development of Program Forms Follow-Up Program ‘Face’ of the Program Implementation of Standardized Orders Data Collection Nursing and Allied Health Education

39. Recommendation #3:Engage administrators and leadership • Program resources • “Silo leadership” • Operating Room • Cath Lab • Critical Care • Management of “bumps on the road” • Complications • Program growth and changing infrastructure requirements

40. Building an effective TAVI Heart Team:Research to support best practices What are the competencies, roles and responsibilities of TAVI nurses/coordinators in different programs? What are the barriers and facilitators to engage multiple physician groups in the trajectory of care of TAVI patients? Does a comprehensive Heart Team approach make a difference to patient outcomes and program success? How is the “voice of nurses” heard in the Heart Team? Does it make a difference?

41. Best practices?Development of a clinical pathway

42. From admission to discharge: Requirements for TAVI Case Selection And Risk Stratification

43. Development of a TAVI Clinical Pathway: A unique opportunity for nurses Patient safety Risk-stratified care Rapid return to baseline status Excellent outcomes ↓ Length of stay Optimized resource utilization

44. Case selection Clinical pathway Early discharge planning Risk stratification Patient and family education Peri-procedural practice Critical care recovery Length of stay Pre-discharge transition Discharge Follow-up

45. Reducing post-procedure length of stay Pre-Procedure

46. Pre-procedure pathway Managing expectations Patient and family education Standardized care Discharge plan

47. Expectations and education • Getting ready for the procedure: • Activity, nutrition and infection prevention • Consider geriatric medicine consultation • Expectation of hospitalisation: • Rapid return to baseline and reconditioning • Rapid transfer out of critical care • Discharge planning and coaching • Home is best: Goal for patient and health care team • Discharge in 1 to 5 days • Individualised discharge planning

48. Reducing post-procedure length of stay PeRI-Procedure

49. Peri-procedural risk stratification ≠ ≠ Risk for Surgery Risk for TAVI

50. Peri-procedural risk stratification Lower risk for TAVI