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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 DISCLOSURES Edwards Lifesciences Consultant Fees/Honoraria WHY 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 Utilizing and are the key! OBJECTIVES 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 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 ACC NCDR REGISTRIES Hospital registries for the in-patient setting ACTION Registry®-GWTG™ CathPCI Registry® ICD Registry™ IMPACT Registry® PVI Registry™ STS/ACC TVT Registry™ Outpatient registries for the ambulatory care setting Diabetes Collaborative Registry™ PINNACLE Registry® SIX HOSPITAL BASED REGISTRIES ACTION Registry–GWTG CathPCI Registry LE peripheral vascular, carotid revascularization and endarterectomy procedures IMPACT Registry Implantable defibrillator procedures PVI Registry Diagnostic LHC and PCI ICD Registry Acute MI treatment Pediatric and adult congenital treatment procedures STS/ACC TVT Registry Transcatheter valve therapy (TAVR, MitraClip) Importance of documentation! EXAMPLES OF CV IMPACT IMPLEMENT BEST CLINICAL PRACICES THE FLAGSHIP OF ALL REGISTRIES… • • • • • One of the oldest Robust High levels of compliance Spans states & institutions Independent audits to maintain integrity of data A LITTLE HISTORY LESSON ABOUT STS DATABASE… 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 LIMITATIONS OF STS DATABASE Short term data 30 days of data only Includes immediate post operative data but not long term… TVT…infancy…but promising! 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… HOW 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. REGISTRIES AND COST… 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 $ IS INSTITUTION SPECIFIC 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! THE 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? THE WAY IT HAD ALWAYS BEEN DONE… Eligibility confirmed by the Heart Team Access determined All cases done in Hybrid OR *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?” General Anesthesia GOALS: Transesophageal echo ICU admission post TAVR minimize the procedure minimize the cost COLLABORATIVE CARE MODEL Anesthesia VCC Cath Lab Staff Nursing Staff Radiology Echo Staff Social Services Administrators OR Staff PT/OT & Nutrition 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 CLOSE TO MY HEART… PROCEDURE DETAILS Minimalist Approach Standard Approach N=70 N=72 P value Procedure Success 70 (100) 69 (96) 0.24 Procedure Mortality 0 (0) 3 (4) 0.24 2nd Valve Implanted 4 (6) 2 (3) 0.43 Concomitant PCI Coronary obstruction 5 (7) 0 (0) 1 (1) 0 (0) 0.11 -- Characteristic OUTCOMES Outcome In-hospital Mortality Hospital Stay – days* Hospital Stay Procedure to discharge – days* 30 day Mortality Minimalist Approach Standard Approach N=70 N=72 P value 0 (0) 3 (4.2) 0.24 4 (3-7) 6 (4-9) 0.01 3 (2-4) 5 (3-6.5) <0.001 0 (0) 4 (6) 0.12 * Median (Interquartile range) COST SAVING WITH MINIMALIST APPROACH $55,377±22,587 $45,485 ± 14,397 TRANSITION TO MINIMALIST TF TAVR Sept 2007 May 2012 • Decrease the number of people in the room • Simplify procedure • Maintain superior outcomes, short and long term • Decrease resource utilization and cost SALIENT POINTS 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 Thank you! 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