Strategies for an Effective Structural Heart Program: Current and Future Considerations

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Strategies for an Effective Structural Heart Program: Current and Future Considerations Eric L. Sarin, MD Co-Director, Structural Heart and Valve Program Co-Director, Cardiovascular Research Inova Heart and Vascular Institute

Disclaimer Please Note: The information provided is the experience of Inova Fairfax Medical Campus, and Edwards Lifesciences has not independently evaluated these data. Outcomes are dependent upon a number of facility and surgeon factors which are outside Edwards control. These data should not be considered promises or guarantees by Edwards that the outcomes presented here will be achieved by an individual facility. Eric L. Sarin is a paid consultant to Edwards Lifesciences

About us

About us TAVR program began in 2010 Hybrid room built Strong administrative support Enthusiasm about the program, but tepid enrollment and growth.

Inova TAVR Growth *149% program growth 2015 vs 2016 162* 62 65 40 14 2012 2013 2014 2015 2016

Starting a program? Need to be ready Exponential growth Complex patients Multiple diagnostic tests Multiple specialists involved New technologies/ procedures

Why Build a SHD infrastructure? Optimize the overall workflow and patient experience Pre-op screening Procedural Outcomes Post-op follow-up Facilitate research trials Most importantly, to have a solid foundation to allow for continued growth and easy transition/ adoption of new technologies

TAVR should lay the foundation for other programs

The Heart Team Concept Multidisciplinary approach to patient assessment and treatment planning Insight from multiple physicians allows for best possible care

Building your Dream Team Look for motivated individuals Interest in new technology Fellowship in SHD Team Players Focus on the best treatment for the particular disease/patient, not on the procedures themselves Aligned incentives, lack of competition Unbiased decision making

Recipe for Success Administrative support Programmatic goals Vision and strategy for growth and improvement TAVR team Collaboration between essential specialties Interventional Cardiology CT surgery Echo Radiology Heart Failure Anesthesia Nursing

Necessary ingredients Collaborators Surgeon, Cardiologist, Radiologist, Anesthesiologist, Echocardiologist, Heart Failure specialist Program infrastructure At least one dedicated NP/RN/PA Efficient evaluation Patient triage Assist with clinical oversight Patient/ family education Admin support Phone number database

Procedural requirements Hybird OR/ Cath Lab Institution dependent Be prepared for anything CPB availability Staff education/ Training Core group Cross training Repeatable environment Worst case scenario

IHVI Past/ Present Infrastructure 2010 2017 2 Cardiac Surgeons 1 Cardiologist 1 NP Patients seen at separate offices Implants one day a month 3 Cardiac Surgeons 4 Cardiologists Dedicated Director 2 NPs 3 RNs 2 Coordinators Dedicated Valve Clinic (physical not virtual) Dedicated Imaging Cardiac Anesthesia

Valve Clinic One stop shop Easy access 2 Surgeon visits Interventional cardiologist eval Echo Registry As much as possible before visit As much as possible day of visit As little as possible after visit

Structural Valve Clinic Identify team members, designate roles Formalize Managing referrals Evaluating patients Operations Standard channels of communication Follow-up Adapt/ Evolve Regular Q/I meetings to address outcomes, finanicials

Processes Referrals Telephone triage/scheduling Reciept and review of records Communication Clinical Clinic oversight Inpatient Education/patient/family Team Regular meetings Coordination Operations Patient review

Inova TAVR Growth *149% program growth 2015 vs 2016 162* 62 65 40 14 2012 2013 2014 2015 2016

2016 growth by month 25 20 21 19 20 15 16 10 5 9 7 8 13 12 13 14 10 0 Jan 16 Feb 16 Mar 16 Apr 16 May 16 Jun 16 Jul 16 Aug 16 Sep 16 Oct 16 Nov 16 Dec 16

Vision for SHD program: the road forward Continued growth of TAVR/ Mitraclip program Active participation and recruitment in new technology trials Continued expansion of research infrastructure Recognition as a national leader in the treatment of SHD

Planning for current and future market opportunities: Keep the foundation strong! Maintain focus on your cornerstone programs TAVR, Mitraclip, Watchman Exquisite results M&M sessions QI projects Financial Health

INOVA TAVR Case Direct Costs TF Direct Costs $80,000 Direct Costs and LOS Trends 10.0 $74,095 *$4,315 cost reduction $70,000 9.0 8.0 $60,000 7.0 $53,089 $52,220 $51,486 $50,000 6.0 $47,171 * $40,000 5.0 $30,000 4.0 3.0 $20,000 2.0 $10,000 1.0 2013 2014 2015 Jan-Jun 16 Jul-Dec 16 $0 2013 2014 2015 2016 AVG Costs $74,095 $53,089 $52,220 $48,858 AVG LOS 9.0 5.0 4.0 3.0 0.0

INOVA TAVR Payment & Contribution Margin/Case Payment Trends Avg CM/Case $57,000 $56,000 $55,000 $10,000 $8,000 Jul-Dec 16, $8,161 $54,000 $6,000 2016, $5,793 $53,000 $52,000 $51,000 $50,000 $4,000 $2,000 2015, $1,776 Jan-Jun 16, $2,071 $49,000 $0 $48,000 $47,000 ($2,000) $46,000 All Payors Medicare ($4,000) 2015 $53,930 $51,281 Jan-Jun 16 $54,209 $49,978 Jul-Dec 16 $55,662 $49,332 2016 $55,097 $49,585 ($6,000) ($8,000) 2014, ($5,854)

Planning for current and future market opportunities: Think outside the box! Creative solutions Mitral Disease Heart failure Case presentation of ViV mitral

Institutional benefits of SHD program

SHD: Current/ Future Growth in TAVR Mitral therapies Ready to scale Ready for new technology

What I would do differently Start with a small team Surgeon, Cardiologist Build infrastructure earlier! Clear leadership roles and hierarchy Motivated people Streamline patient experience Customer service extends to referring providers!

Questions? Thank you! eric.sarin@inova.org

Please see important safety information at the Speaker s Podium Edwards, Edwards Lifesciences, the stylized E logo, SAPIEN, SAPIEN XT and SAPIEN 3 are trademarks of Edwards Lifesciences Corporation. All other trademarks are the property of their respective owners. PP--US-2373 v1.0