1. CoRPS Center of Research on Psychology in Somatic diseases The Medtronic Sprint Fidelis lead advisory notification has no adverse impact on patient reported outcomes in Danish implantable cardioverter defibrillator patients Susanne S Pedersen (PhD) 1,2,3 Professor of Cardiac Psychology 1 CoRPS - Center of Research on Psychology in Somatic diseases, Tilburg University, The Netherlands 2 Thoraxcenter, Erasmus Medical Center, Rotterdam, The Netherlands 3 Department of Cardiology, Odense University Hospital, Denmark 4 Department of Cardiology, Aarhus University Hospital, Denmark Co-authors: Henneke Versteeg (MSc) 1 Jens Cosedis Nielsen (MD, PhD) 4 Peter T Mortensen (MD) 4 Jens Brock Johansen (MD, PhD) 3

2. CoRPS Disclosures Moderate speaker or consultancy fee from: Medtronic St. Jude Medical Cameron Health Sanofi Aventis

3. CoRPS Background: General Urgent need to examine the influence of advisory notifications on patient well being and how to communicate the risk to patients A true estimation of the impact of advisories on patients may counterbalance the associated negative publicity in the press Cannom & Fisher. Pacing Clin Electrophysiol 2008; 31:1233-5

4. CoRPS Negative publicity has consequences Dr. Christopher J. Magovern, right, at Morristown Memorial Hospital in New Jersey during a procedure Tuesday to replace a patient’s defibrillator and the wire that connects it to the heart. Feder. New York Times, December 13, 2007 Feder, New York Times, September 12, 2008 But thousands of other patients with failing hearts remain trapped in doubt…. Should they have the potentially faulty wire, or lead, removed - or leave it in place and hope it does not fail? Dr. Eric N. Prystowsky, a nationally renowned heart rhythm specialist in Indianapolis, said every doctor in his field was haunted by individual cases… The student had an abnormally thick heart muscle, a known risk for sudden cardiac arrest. “He kept putting it off,” Dr. Prystowsky said of the decision to get a defibrillator. “Six weeks later, his fiancée called to say he had been found dead in bed.”

5. CoRPS Background: Studies to date 273 advisory patients

6. CoRPS Objectives 1.To examine whether the mode used to inform patients about the Sprint Fidelis device advisory is associated with patient reported outcomes (PROs) 2.To determine whether patients with a device advisory notification report poorer PROs compared to non advisory patients

7. CoRPS Methods: Study design and participants Case-control study Cases: 207 patients implanted with an ICD between 1993-2009 at Aarhus University Hospital (Skejby), Denmark, and with a lead (6931 or 6949) subject to the Medtronic Sprint Fidelis ICD lead advisory  (response rate 87%) Controls*: 510 patients implanted with an ICD between 1991-2006 without hardware subject to advisory  (response rate 84%) * Johansen, Pedersen et al. Europace 2008;10:545-51

8. CoRPS Methods: Mode of informing patients (i)By letter in December of 2008 calling them in for an urgent clinical follow-up visit (ii)Informing them ad-hoc during a routine clinical visit * Both groups had the Lead Integrity Alert (LIA) software downloaded to their device and were informed about the rationale at the time of downloading it to their device. The interval between the device advisory notification and completing the questionnaires was 9 months in group (i), while for group (ii) the interval was variable

9. CoRPS Methods: Patient reported outcomes (PROs) Anxiety and depression: Hospital Anxiety and Depression Scale (HADS) Device concerns: ICD Patient Concerns Questionnaire (ICDC) * Device acceptance: Florida Patient Acceptance Survey (FPAS) * Health status: Minnesota Living with Heart Failure Questionnaire (MLHFQ) * Short Form Health Survey (SF-36) * Disease-specific measure

10. CoRPS Results: Baseline characteristics stratified by device advisory mode and controls CharacteristicsDevice advisory (i) (N = 74) Device advisory (ii) (N = 133) Controls (N = 510)p Demographic Women8 (10.8)20 (15.0)92 (18.0).26 Age, mean ±SD63.2 ±13.261.6 ±14.764.0 ±13.1.18 Partner/married58 (78.4)102 (77.1)393 (77.5).94 Clinical CRT-D22 (30.1)30 (22.6)92 (18.0).04 Comorbidity15 (20.8)29 (22.3)116 (23.0).92 Ischemic heart disease49 (70.0)81 (67.5)327 (70.6).80 Smoking13 (17.6)26 (19.8)119 (23.8).36 Time since first ICD implant (yrs)2.0 ±1.12.2 ±1.55.3 ±3.2<.0001 1 Medication Amiodarone10 (15.4)34 (27.0)123 (24.4).19 Beta-blockers54 (83.1)116 (92.1)412 (82.4).03 Diuretics28 (43.1)54 (42.9)236 (46.9).64 Thiazide diuretics10 (15.4)12 (9.5)46 (9.3).30 ACE-inhibitors52 (80.0)98 (77.8)345 (69.8).07 ARBs13 (20.0)37 (29.4)156 (31.1).18 Digoxin15 (23.1)23 (18.3)84 (16.7).43 Psychotropic medication11 (16.9)9 (7.2)67 (14.1).08

11. CoRPS Results: Psychological distress stratified by device advisory notification mode

12. CoRPS Results: Health status stratified by device advisory notification mode

13. CoRPS Results: Psychological distress stratified by device advisory status Controls more ICD concerns

14. CoRPS Results: Health stratified by device advisory status Controls poorer Mental Health

15. CoRPS Strengths Second largest cohort of device advisory patients to date First Danish study Use of a wide range of PROs (i.e., distress, device acceptance, and health status) Use of both disease-specific and generic PROs Keren, Sears et al. J Cardiovasc Electrophysiol 2011;22:57-63

16. CoRPS Limitations Convenience sample as control group Time interval (>9 months) from notification to patient completion of PROs – patients may adapt over time No evaluation of patient perception of the risk of having a recalled Sprint Fidelis lead Control cohort was predominantly secondary prevention

17. CoRPS Conclusions Mode used to inform ICD patients about the Sprint Fidelis lead advisory was not associated with PROs Device advisory patients reported similar well being and health status as compared to controls Results indicate that ICD patients are generally able to cope with a device advisory Lead failures are likely to be here to stay - suggestion to include routine and serial assessments of PROs in national registries Pedersen, Theuns, et al. Pacing Clin Electrophysiol 2009;32:1006-11

18. CoRPS Living in a Device World: Focus on Recent Challenges and Tools to Improve Clinical Care for Patients with an Implantable Cardioverter Defibrillator Device Conference, 3-4 November 2011, Tilburg, the Netherlands Themes OVERCOMING THE SHOCK OF THE ICD ICD REGISTRIES AND THE INCLUSION OF THE PATIENT PERSPECTIVE DEACTIVATION OF THE ICD AND END OF LIFE ISSUES NEGLECTED SUBGROUPS CRT SELECTION AND RESPONSE THE DO’S AND DON’TS OF PATIENT COMMUNICATION SEXUALITY IN ICD PATIENTS BEHAVIORAL INTERVENTIONS LOOKING INTO THE FUTURE Selection of invited faculty Nico Blom (MD, PhD), Leiden University Medical Center, NL Matthew Burg (PhD), Yale School of Medicine, USA Viviane Conraads (MD, PhD), University Hospital Antwerpen, BE Dorothy Frizelle (PhD), University of Hull, UK Jens Brock Johansen, (MD, PhD), Odense University Hospital, DK Karl-Heinz Ladwig (MD, PhD), Helmholtz Institute, Munich, GE Mathias Meine (MD, PhD), University Medical Center Utrecht, NL Susanne S. Pedersen (PhD), CoRPS, Tilburg University, NL Samuel Sears (PhD), East Carolina University, USA Steen Pehrson (MD, PhD), Copenhagen University Hospital, DK Dominic Theuns (PhD), Erasmus Medical Center Rotterdam, NL More information available on: www.tilburguniversity.edu/device2011