1. Utilizing Registries and Guidelines in CV Care: Have They Improved Outcomes & Decreased Cost? Amy Simone, PA-C Emory University Hospital Structural Heart and Valve Program

2. D ISCLOSURES Edwards Lifesciences Consultant Fees/Honoraria

3. W HY IS THIS RELEVANT ? We all share common goals as practitioners To provide patients with the best clinical practice implementing the most current therapies To achieve the best possible clinical outcomes To do so in a financially responsible way to ultimately decrease overall expenditure to the health care system

4. O BJECTIVES Multiple CV registries are collecting data utilized to promote best clinical practices which improves clinical outcomes The STS database is the flagship surgical registry and this data is instrumental in guideline formulation Financial impact of registry data is institution specific as there is no inherent cost element within national registries Through examination of both national and institutional data, Emory University implemented the Minimalist Approach to TAVR with a proven cost benefit

5. ACC NCDR REGISTRIES National Cardiovascular Data Registry Developed in 1997 by ACC Quality initiative to improve CV care through application of data Multiple registries capture reliable data  drives quality at level of both provider and institution Various dedicated & specific registries This data prompts guideline formation which improves patient care worldwide Guidelines update and enforce best clinical practices and standards of care according to evidence based medicine

6. ACC NCDR REGISTRIES Hospital registriesHospital registries for the in-patient setting ACTION Registry ® -GWTG™ CathPCI Registry ® ICD Registry™ IMPACT Registry ® PVI Registry™ STS/ACC TVT Registry™ Outpatient registriesOutpatient registries for the ambulatory care setting Diabetes Collaborative Registry™ PINNACLE Registry ®

7. SIX HOSPITAL BASED REGISTRIES ACTION Registry–GWTG Acute MI treatment CathPCI Registry Diagnostic LHC and PCI ICD Registry Implantable defibrillator procedures PVI Registry LE peripheral vascular, carotid revascularization and endarterectomy procedures IMPACT Registry Pediatric and adult congenital treatment procedures STS/ACC TVT Registry Transcatheter valve therapy (TAVR, MitraClip) Importance of documentation!

8. E XAMPLES OF CV IMPACT IMPLEMENT BEST CLINICAL PRACICES

9. THE FLAGSHIP OF ALL REGISTRIES… One of the oldest Robust High levels of compliance Spans states & institutions Independent audits to maintain integrity of data

10. A L ITTLE H ISTORY L ESSON A BOUT STS D ATABASE … Formed in 1989 as a quality initiative The website states 94% of adult cardiac surgery centers are participating In the year 2014 there were 94 publications which utilized data from the STS database. These publications have impacted clinical care by removing variables – i.e. experience of the surgeon, case acuity of the hospital, number of surgeries performed at the institution annually, etc. The STS is… AVERAGE COMPARIBLE DATA i.e. STS risk stratification score

11. L IMITATIONS OF STS DATABASE Short term data 30 days of data only 30 days of data only Includes immediate post operative data but not long term… o Just starting out…formed 12/2011, mandatory 5/2012 by National Coverage Decision o Purpose: safety & efficacy of new devices o Frequent additions and updates, constant evolution o Period of data collection is one year o Can query CMS o Lessons learned… TVT…infancy…but promising!

12. H OW DO REGISTRIES IMPACT GUIDELINES ? The STS Workforce on Evidence Based Surgery  Creates Guidelines Areas of responsibility will include the development of patient management protocols and guidelines, and enhancement of the dissemination and implementation of STS practice guidelines.

14. R EGISTRIES AND C OST … National registries do not report a national cost element Data only! No relationship with CMS (*other than TVT) No national cost averages are known within registries themselves $ I S I NSTITUTION S PECIFIC No financial link between registry data and CMS* unless requested by an institution The relationship between implementing guideline directed therapy and cost reduction is institution specific Real World!

15. T HE ELEPHANT IN THE ROOM … $ Cost of Device, Complications, Procedure, Recovery… How can we make TAVR more cost effective while preserving superior clinical outcomes and protecting patients? Which costs are fixed and which are variable ?

16. THE WAY IT HAD ALWAYS BEEN DONE… Access determined All cases done in Hybrid OR General Anesthesia ICU admission post TAVR Transesophageal echo Eligibility confirmed by the Heart Team *This was the plan of care for ALL patients, no matter what the access or patient status* “We had used MAC in the OR a few times…Could this be transitioned to the Cath Lab?” minimize the procedure minimize the cost GOALS:

17. C OLLABORATIVE C ARE M ODEL Nursing Staff Echo Staff Administrators PT/OT & Nutrition Anesthesia Cath Lab Staff Radiology Social Services OR Staff VCC

18. THE MOVE TO THE MINIMALIST APPROACH AT EMORY UNIVERSITY A true collaborative effort between all members of the Heart Team Illustrating the value of non-physician members of The Heart Team Valve Clinic Coordinator  patient screening and selection Nursing Staff  care of this nuanced & tenuous population Echo, Cath Lab staff  intraprocedure logistics Administrators  institution “buy in” PT/OT/SS  patient recovery, early discharge planning

19. C LOSE TO MY HEART …

20. P ROCEDURE D ETAILS Characteristic Minimalist Approach N=70 Standard Approach N=72P value Procedure Success70 (100)69 (96)0.24 Procedure Mortality0 (0)3 (4)0.24 2 nd Valve Implanted4 (6)2 (3)0.43 Concomitant PCI5 (7)1 (1)0.11 Coronary obstruction0 (0) --

21. O UTCOMES Outcome Minimalist Approach N=70 Standard Approach N=72P value In-hospital Mortality 0 (0)3 (4.2)0.24 Hospital Stay – days* 4 (3-7)6 (4-9)0.01 Hospital Stay Procedure to discharge – days* 3 (2-4)5 (3-6.5)<0.001 30 day Mortality0 (0)4 (6)0.12 * Median (Interquartile range)

22. $45,485 ± 14,397 $55,377±22,587 C OST S AVING WITH M INIMALIST A PPROACH

23. TRANSITION TO MINIMALIST TF TAVR Decrease the number of people in the room Simplify procedure Maintain superior outcomes, short and long term Decrease resource utilization and cost May 2012 Sept 2007

24. S ALIENT P OINTS The data placed into registries promotes best clinical practice and is instrumental in improving outcomes within multiple aspects of CV care The STS database is the flagship surgical registry from which guidelines and standards of care are formed Financial impact of registry data is institution specific Data exploration prompted the implementation of the Minimalist Approach at Emory University and has decreased cost to the health care system

25. Thank you! Amy.Simone@emoryhealthcare.org