1. Early Experiences with Developing a Percutaneous Valve Program in the US Kimberly A. Skelding MD FACC FAHA FSCAI Director Cardiovascular Research Interventional Cardiologist Geisinger Health System

2. | 2 Not just a research protocol…. Paradigm shift Closing the gap on patients without previous care at times Changing thought processes in non-specialty care Providing a full gamut of care

3. | 3 Valve program Programatic requirements –Ancillary staff training Clinical visits –Time –Support staff –Flexibility Getting care to patients in need –Patients under or not treated

4. | 4 Need to have full service program Surgeon(s) on board Take all comers –The good the bad and the ugly Plans for patients done in timely fashion –Need to provide good service to referring physicians –Clinic availability Communication quick and transparent to referring physicians and patient –If patients are not candidates best to tell them quickly and not string them along –Quick answers allow other plans to be made

5. | 5 | 5 Comprehensive Valve Program – First Clinical Visit Patients seen by cardiologist and surgeon at same visit Echo’s done prior to appointment when necessary Decision for therapy determined at the time of visit If TAVI candidate -set up that day for CT/echo if needed -set up for cath if appropriate -timeline clear for steps to -consent given to patient to review Letters sent at each stage of process | 5

6. | 6 Comprehensive Valve Program – Second Clinical Visit CT scan and echocardiogram Visit with research coordinator for question/answer regarding trial and consent –Valve coordinator if not in clinical trial Grip test, MMS test, walk test –Clinical trial requirements –Helpful to identify patients who will do well Prepare for screening committee presentation –Clinical trial only

7. | 7 Typical Outcome of Valve Clinic Day 3 surgeries 3-4 candidates for TAVI 3-4 patients need further testing –Many found to not be appropriate –Our common exclusion for patients with valve areas <0.8 is gradient not high enough & normal EF Lots of “dumps” you need to happily take –Closed head injury –Dialysis patients –Mild to moderate but “funny symptoms” –No insurance –Challenging patients

8. | 8 Can you start these programs? Interest? Valvuloplasty? Training Interest Local expert?

9. | 9 Preparation Knowledge base in structural heart disease Trained well Trustworthy Partner in Echo Lab Build Patient Base Become the go-to person Competition

10. | 10 EHR Benefits to find patients Review of echo database –quick –1000’s of patients with appropriate echos –?symptoms Review of health record itself –Quick first pull –Sifting through for symptoms and class time consuming Review of health plan participants (if available) –As above

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12. | 12 Contact with outside hospitals Visits Phone calls Letters

13. | 13 Implantation is just the beginning of the journey…. Trained recovery suite team New anesthesiology algorhythms Surgery colleagues involvement CCU care nurses residents & fellows Complications you would not ever expect, plan for, or “protocolize” If you are the champion, you need to be involved all along the way

14. | 14 For the referring physicians: Make it easy, make it quick, be complete, provide good service… but in the end patients often self refer For the operator: Lots of work, an underestimation of time commitment Ego <<<< Good Clinical Practice Most rewarding new procedure

15. | 15 Position yourself to start program Position yourself for success Become irreplaceable Use programs such as these to network for training opportunities Good Luck!