1. TAVR Addressing Real-Life Issues CRT 2013 Washington DC
Marian Hawkey RN
Center for Interventional Vascular Therapy
NewYork Presbyterian/Columbia University Medical Center
New York, NY

2. Marian C. Hawkey, RN
Within the past 12 months, I have had a financial interest/arrangement or affiliation with the organization(s) listed below.
Affiliation/Financial Relationship: Consulting Fees/Honoraria
Company: Edwards Lifesciences

3. TAVR Current US Landscape
Commercial Access
Clinical Trials
Edwards SAPIEN
Excessive Risk
Transfemoral
High Risk
Transapical
Edwards SAPIEN
Partner 2 Trial
Intermediate Risk
Randomized to sAVR
Excessive Risk
Registries
Medtronic CoreValve®
Continued Access Study
High/Very High Risk
SURTAVI

4. What ARE the “real-life” issues?
Establishing processes for patient evaluation
Managing team dynamics
Infrastructure
Time and space
Building referral volume
Developing a Heart Team
Mitigation of procedural risk
Patient selection challenges
Managing expectations of patients,
families, referring providers
Program growth and financial viability

5. Embracing New Technology in the “Real World”
Making the transition from clinical research to clinical practice
STRONG institutional support
Collaborative team concept
Multiple moving parts
Developing a valve team (easier said than done)
Identification of key team players
Multidisciplinary clinical evaluation process
Technical expertise
Process development and implementation
Allow for growth and flexibility
Selecting the right patients

6. The Heart Valve Team “sine qua non” of a TAVR program
Guidelines on the management of valvular heart disease (version 2012)
The Joint Task Force on the Management of Valvular Heart Disease
of the European Society of Cardiology (ESC) and the European
Association for Cardio-Thoracic Surgery (EACTS)
The Centers for Medicare & Medicaid Services (CMS) covers transcatheter aortic valve replacement (TAVR)
under Coverage with Evidence Development (CED) with the following conditions:
TAVR is covered for the treatment of symptomatic aortic valve stenosis when furnished according to a
Food and Drug Administration (FDA)-approved indication and when all of the following conditions are met
The procedure is furnished with a complete aortic valve and implantation system that has received FDA
premarket approval (PMA) for that system's FDA approved indication.
Two cardiac surgeons have independently examined the patient face-to-face and evaluated the patient's
suitability for open aortic valve replacement (AVR) surgery; and both surgeons have documented the
rationale for their clinical judgment and the rationale is available to the heart team.
The patient (preoperatively and postoperatively) is under the care of a heart team: a cohesive,
multi-disciplinary, team of medical professionals.
The heart team concept embodies collaboration and dedication across medical specialties to offer
optimal patient-centered care.

7. Moving Parts Referral Sources Institutional Support
Dedicated Valve Program Staff
Interventional Cardiology
CT Surgery
Anesthesia
Administrative
Staff
Cath Lab
Patients
Families
Clinical Staff
Cath Lab/OR
Cardiac Critical Care Units
Telemetry/Cardiac Units
Sub-specialty Consultants
Operating Room
Echo
Advanced Imaging
Perfusion
Clinical Research Staff

9. The Central Role of the Program Coordinator
NP/RN/PA
Coordination of “moving parts”
Facilitate efficient evaluation process (valve clinic)
Patient triage
Assist with patient management
Communication with referrings
Patient/family communication and education
Staff education
Clinical trial oversight/support
Etc. 10

10. The voice of reason Marketing and outreach
Development of standardized orders
Marketing and outreach
Deal with reimbursement issues
Clinical assessment and triage
Coordination of diagnostic work-up
Data collection
Consent Process
Communication with patients and families
Coordination of clinical trials
Valve Clinic schedule and operations
The voice of reason
Schedule procedures and pre-op testing
Referrals and
Intake
Program
Development
Coordination of heart team activities and processes
Patient follow-up
Staff education
Management of expectations
Represent program to patients, families, referrings etc.
Communication with referring providers
Waitlist
Management
Patient and family education
Fostering of essential relationships
Process
Development

11. Clinical Processes Establish and maintain contact with referrings
Facilitate valve clinic appointments and scheduling/review of diagnostic testing
Inpatient service support
Key point of contact with patient and family
Provide “road map”/navigation
Manage expectations
Initiate consent process
Waitlist management
Keeping track of the “small” details

12. Developing and Sustaining The Heart Team and Program
“Face” of the program
Create communication pathways
Process development
Evaluation of processes
Data management
Clinical research operations and coordination
Marketing and outreach
Education

13. Patient-Centered Care
Represent program to patients and families
Familiarity with individual patients
Insights on patient selection
Making procedural information accessible and comprehensible
Understanding the needs of the patient population
Being an advocate for patients and families

14. Patient-Specific Considerations
Elderly
Multiple comorbidities
Sensory and/or cognitive deficits
Mobility impairment
Multiple family members involved in decision-making process
Determining operability status
Risk assessment
Is TAVR technically feasible and safe?
Is TAVR appropriate for this patient?

15. Making Balanced Treatment Decisions
Utility
vs.
Futility
Should we do this?
Realistic post-treatment goals
Can we do this?
Technical feasibility

16. Patients and Families Educational Imperatives
Complex nature of procedure-related information
In most cases, family involvement is essential
Awareness of sensory impairments
Awareness of cognitive impairments
Assessment of ability to provide consent
Utilization of educational tools i.e. procedure animations
Allow plenty of time for discussion and to obtain consent
Management of patient and family expectations
Addressing misperceptions

17. Peri-Procedural Processes
Keep referring practitioner in loop
Clinical trial vs. commercial procedures
Internal communication regarding schedule, logistics etc.
Integration of Cath Lab/OR staff
Device management
Creation of standardized orders
Facilitated discharge planning

18. Procedural Essentials
Hybrid OR and/or Cath Lab
Necessary surgical and interventional equipment must be available in either location
Cardiopulmonary bypass on stand-by
Staff education and training
Core group to “own” TAVR procedures
Inventory checklist
Cath lab/OR cross-training
Scrub/circulating nurse roles
Create familiar environment for staff
Worst-case scenario planning
Designation of primary procedure days

19. Integrating AS Patients Into Your Clinical Environment
How will these patients change the demographics, staffing ratio, length of stay etc. in your interventional cardiology step-down unit?
Adaptation of clinical staff
Expertise in care and management of patients with aortic stenosis
Key sub-specialty consultants on speed dial
Develop of competency assessment for nursing staff
Expertise in care and management of geriatric patients
Strong support from social workers, physical/occupational therapists etc.

20. Looking to the future New devices and expanded indications
Ongoing challenges associated with complex patient populations
Relationships in the international transcatheter valve therapy nursing community will continue to play an essential role
Sharing of processes
Collaborative research
Expansion of our evidence-base for clinical practice

21. In Conclusion Physician expertise is of critical importance
Of equal importance is engagement of experts (RN, NP, PA etc.) who will:
Develop and implement processes for managing referrals, efficient patient evaluation, valve clinic operations
Foster essential relationships and educational opportunities
Take ownership for program growth
Know their patients (literally) inside and out