1. What Patients Need and Want to Know from their Physicians FDA Perspective Brian Lewis, MD, Medical Reviewer, FDA Division of Cardiovascular Devices Electrophysiologist, HRS Member

2. What Patients Need and Want to Know from their Physicians FDA Perspective Brian Lewis, MD, Division of Cardiovascular Devices What Patients Need

3. FDA Perspective3 Especially at recalls, FDA recognizes and supports –individual patient’s informed decisions –the care and advice of their expert physicians –timely, accurate, updated, complete information –clear communication Example: Telectronics Accufix Lead Summary of FDA Perspective

4. FDA Perspective4 Especially at recalls… FDA recognizes and supports: …all FDA efforts support these…first. Summary of FDA Perspective Patient’s Needs Patient’s Care

5. FDA Perspective5 Patients’ needs determine what requires attention. But how? Patient’s Needs Pacemaker ICD CRT Lead Recall

6. FDA Perspective6 KEY LINK Most Critical Device Functions Patient’s Needs Pacemaker ICD CRT Lead Recall

7. FDA Perspective7 The most critical device functions provide the key link. ex: - survival functions - timely functions Most Critical Device Functions Patient’s Needs Pacemaker ICD CRT Lead Recall

8. FDA Perspective8 the most critical functions + the patient’s needs =============== what needs attention So, different patients may depend on the same device for very different needs, and… Most Critical Device Functions Patient’s Needs Pacemaker ICD CRT Lead Recall

9. FDA Perspective9 Different patients may have very different needs all within a single recall!

10. FDA Perspective10 Consider: - failure of an atrial lead in a pacemaker patient with chronic AF - failure of pacing in an ICD with adequate NSR and normal conduction Most Critical Device Functions Patient’s Needs Pacemaker ICD CRT Lead Function

11. FDA Perspective11 Patient’s Needs Most Critical Device Functions FDA recognizes that the most critical or timely device functions need the most attention when considering all recall patients as a group …and that care of individual patients is considerably more complex

12. FDA Perspective12 Informed Decisions: individual perspective –draw on their own experiences –ask questions –enlist expert physician help –consider what they have learned about treatment risks, benefits, the balances and the alternatives –ask “What would the doctor do if they were me?” –revisit, revise and rethink things –require clear communications –check comprehension

13. FDA Perspective13 FDA’s informed decisions are similar: –experience helps –questions help –consultations occur –treatment risks, benefits, balances and alternatives are considered –updates are expected –communications must be clear –information = care

14. FDA Perspective14 But care is different than managing a recall: –care is individualized, episodic, fluid, ongoing, evolving –care is person to person –individuals approach different issues differently –implants are long-term, so removal has its own risks urgent removal may not be helpful issues with the PG may be addressed at change out lead issues are more complex –recalls must address all affected individuals

15. FDA Perspective15 Real Life example: the Accufix Lead

16. FDA Perspective16 Real Life example: the Accufix Lead Recall Issue: fracture and protrusion of a shaping element 3 Accufix “J” lead models 41,000 implants worldwide 6400 patients are still living with the lead today all leads are now at least 10 years old two deaths and two cardiac tamponades were originally noted Action: recall; sales halted; intensive tracking of affected patients independent review group formed intermittent updates and recommendations published

17. FDA Perspective17 Real Life example: the Accufix Lead Recall Challenge: low long-term risk of death and cardiovascular perforation noted larger risks were associated with explanting the lead Lessons Learned: not all recall devices require removal removal may be associated with its own risks there is no substitute for long term follow-up data

18. FDA Perspective18 Especially at recalls… FDA recognizes and supports: …all FDA efforts support these…first. Summary of FDA Perspective Patient’s Needs Patient’s Care