1. CoRPS Center of Research on Psychology in Somatic diseases The patient perspective on LVAD implantation – a neglected dimension? Prof. dr. Susanne S. Pedersen, Tilburg University, Tilburg

2. CoRPS A device replacing a donor heart?

3. CoRPS Development of left ventricular assist devices (LVADs) Despite the advances in medical care there is a rising prevalence of HF and an increased need for donor hearts Since 1967 ± 1000 HTx in the Netherlands LVAD development means a delay in the need for a donor heart, which is time saved on the HTx waitinglist. LVADs as BTT and DT (January 2010 FDA approved) 1 st generation pulsatile devices 2 nd generation continuous-flow devices: axial flow pump (HeartMate II) and centrifugal flow pump (HVAD HeartWare) HeartWare International Inc.; HeartMate II, Thoratec, Texas Heart Institute

4. CoRPS 1 st generation pulsatile devices2 nd generation continuous-flow devices Two generations of LVADs HeartWare International Inc., HeartMate II, Thoratec, Texas Heart Institute

5. CoRPS LVAD1 st year survival rate2 nd year survival rate Pulsatile55% (95% CI: 42-69)24% (95% CI: 1-46) Continuous68% (95% CI: 60-75)58% (95% CI: 49-67) Development of left ventricular assist devices (LVADs) Slaughter et al. (2009); Pagani et al. (2009); Miller et al. (2007)

6. CoRPS Note: Personality traits, lifestyle demands, culture, and comorbidity might alter the apparent relationships between the pathophysiology of heart failure and reported symptoms LVAD, QoL and psychological distress Rector et al. (2005)

7. CoRPS Patients Little research on functional, social and psychological adjustments (= patient reported outcomes (PROs)) and impact of LVAD support Unfortunate since PROs can be used to assess the effectiveness of treatment, to enhance the quality of care and management of patients, and to help allocate resources to patients who need it the most Poor PROs predict worse outcome and hospitalization Information can not be extrapolated from medical record Psychological problems in HF patients often prominent, under-diagnosed and unexplained (15-36% depression en 40% anxiety) HM II: Miller (2007); Allen (2009); Rogers (2010); Casida (2010); Baker (2010) LVAD, QoL and psychological distress

8. CoRPS In 1993 first article published on QoL and psychological factors in LVAD patients, as of today only n≈25 articles Strong correlation with non-adherence, coping, self-efficacy, poor lifestyle, LVAD concerns, complications and clinical outcomes Konstam (2005); Samuels (2004); Grady et al. (2000, 2002, 2004) LVAD, QoL and psychological distress

9. CoRPS LVAD review – pulsatile devices Brouwers, Denollet, De Jonge, Caliskan, Young, Pedersen (in press Circ Heart Failure)

10. CoRPS LVAD review – continuous-flow devices

11. CoRPS Improvement in QoL? Grady et al. (2002, 2004)

12. CoRPS Most continuous-flow LVAD studies show significant improvements in mean health status scores, using the MLHFQ, KCCQ, SF-36 and EuroQol EQ-5D, from baseline up to 3, 6 and 12 months follow-up (all ps<0.05) After 3 months QoL improvement stabilizes Physical disability becomes less prominent, patients feel less fatigued and sleep better, thereby increasing the ability of self-care and ambulation Many patients may experience psychosocial problems and impaired psychological well-being, especially around 1 month after implantation Patients report feelings of sadness, helplessness, irritability, feeling useless to others and having a sense of loss of control over one’s life Improvement in QoL?

13. CoRPS QoL pulsatile vs. continuous-flow LVAD Slaughter et al. (2009) HEARTMATE II TRIAL, Starling et al. (2011) INTERMACS REGISTRY No significant difference! Caused by the improved durability, decrease in complications, smaller size and silent operation of the continuous-flow device? HeartMate II trial INTERMACS registry

14. CoRPS QoL continuous-flow LVAD - axial and centrifugal Meyers et al. (2010) satisfaction limitations * p<0.05

15. CoRPS QoL Bridge-to-transplant vs. Destination Therapy QoL reaches a plateau at 3 months Improvement in health status scores between baseline and 6 months MLHFQ: DT -40 versus BTT -29 points KCCQ-OSS: DT 39 versus BTT 28 points KCCQ-CSS: DT 36 versus BTT 24 points Rogers et al. (2010)

16. CoRPS QoL LVAD vs. HTx Kugler et al. (2010)

17. CoRPS QoL LVAD vs. HTx/ healthy controls

18. CoRPS Anxiety and Depression in LVAD patients Retrospective! Cross- sectional! Dew et al. (2000), Bunzel et al. (2005)

19. CoRPS Only one retrospective study on anxiety and depression in patients with continuous flow LVADS (N=41) Large difference in prevalence of depression: 2%-50% depression depending on the study design and instrument used Depression and anxiety associated with worrying about LVAD noise and malfunction, complications, waiting for a donor heart and being away from family Anxiety and Depression in LVAD patients

20. CoRPS Anxiety and Depression in LVAD patients vs. OMT and HTx Rose et al. (2010), Dew et al. (1999) *** p<0.001

21. CoRPS Low number of patients in most study samples (median= 37 (mean ± standard deviations 100 ± 157.22)) Low number of PRO follow-up measures Strong request for identifying the predictors of QoL and a focus on coping due to the use of LVAD for longer periods of time (DT) Methodological insufficiencies: no information on handling of missing data and clinical relevant change, no intra-individual change, no optimal use of instruments (i.e. KCCQ) Conclusion: There is a need for more research on the psychological dimensions of QoL of LVAD patients and their partners; in order to improve the focus and structure of LVAD rehabilitation programs  primary outcome variable! LVAD review – Limitations and Conclusion

22. CoRPS Study objective ADJUST-LVAD Primair: To examine changes in health status (functional status and quality of life) and emotional distress (i.e. anxiety and depression) over time in patients following LVAD implantation, with a view to delineating a profile of high-risk patients with respect to the outcomes.

23. CoRPS Methods: Participants and Design Inclusion: all patients with HMII or HeartWare, age>18, from UMCU, EMC and St. Paul’s hospital, and their consecutive others 2 year follow-up (=36 months after implantation) for mortality/ morbidity and HTx Inclusion after LVAD implantation during stay in Medium Care Unit Follow-up patients during visit at the outpatient clinic (questionnaires partner by mail if necessary)

24. CoRPS Socio-demographical variables Sex Age Marital status Education Employment Smoking/ Alcohol Participation in rehabilitation program Under treatment by psychologist/psychiatrist Methods: Socio-demographic and Clinical variables Clinical variables Diagnose and implantation (etiology/time of onset HF/emergency, urgent or semi-selectieve implantation/informed consent LVAD) Clinical history (previous valve replacement, PCI, CABG, ICD) Comorbidity ECG Echocardiography Hematological levels Excersise capacity test Medication (HF/psychotropic medication) Complications/mortality/ HTx

25. CoRPS Methods: Psychological measures

26. CoRPS Goal and Hypotheses Goal: Gain insight in the effect of an LVAD implantation on patient and partner by using and inter- and intra-individual approach  improvement in care and well-being of LVAD patients and their partners in the future Hypotheses: Patients with a low QoL have high levels of emotional distress have worse clinical outcomes and suffer from more complications and morbidity Patients with a Type D personality experience a worse QoL/functional status with more complications, hospitalizations and pain The QoL and psychological status of the patient and partner have a strong effect on the marital quality and degree of loneliness

27. CoRPS Looking into the future Will the technologal advances lead to a better QoL? Optimal care for increasing number of LVAD patients if indication expands to DT worldwide?

28. CoRPS Project Participants CoRPS - Center of Research on Psychology in Somatic Diseases, Tilburg University Prof. dr. Susanne S. Pedersen (PhD) Prof. dr. Johan Denollet (PhD) Drs. Corline Brouwers (Msc) St. Paul’s Hospital, Vancouver, Canada Annemarie Kaan Dr. Quincy Young (PhD) University Medical Center Utrecht Prof. dr. Jaap Lahpor (MD, PhD) Dr. Nicolaas de Jonge (MD, PhD) Erasmus Medical Center Rotterdam Dr. Kadir Caliskan (MD) Dr. Aggie Balk (MD) Dr. Lex Maat (MD)

29. CoRPS Contact details Prof. dr. Susanne S. Pedersen Phone: + 31 (0) 13 466 2503 E-mail: S.S.Pedersen@uvt.nl CoRPS - Center of Research on Psychology in Somatic diseases, Tilburg University, The Netherlands www.tilburguniversity.nl/corps