Transcript Chronic anxiety in ICD patients: A multi

The patient perspective on LVAD implantation – a neglected
CoRPS dimension?
Prof. dr. Susanne S. Pedersen, Tilburg University, Tilburg
Center of Research
on Psychology
in Somatic diseases
CoRPS
A device replacing a donor heart?
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)
• 1st generation pulsatile devices
• 2nd generation continuous-flow devices: axial flow pump (HeartMate II)
and centrifugal flow pump (HVAD HeartWare)
HeartWare International Inc.; HeartMate II, Thoratec, Texas Heart Institute
CoRPS
Two generations of LVADs
1st generation pulsatile devices
2nd generation continuous-flow devices
HeartWare International Inc., HeartMate II, Thoratec, Texas Heart Institute
Development of left ventricular assist devices
CoRPS
(LVADs)
LVAD
1st year survival rate
2nd year survival rate
Pulsatile
55% (95% CI: 42-69)
24% (95% CI: 1-46)
Continuous
68% (95% CI: 60-75)
58% (95% CI: 49-67)
Slaughter et al. (2009); Pagani et al. (2009); Miller et al. (2007)
CoRPS
LVAD, QoL and psychological distress
Note: Personality traits, lifestyle demands, culture, and comorbidity might
alter the apparent relationships between the pathophysiology of heart
failure and reported symptoms
Rector et al. (2005)
CoRPS
LVAD, QoL and psychological distress
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)
CoRPS
LVAD, QoL and psychological distress
• 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)
CoRPS
LVAD review – pulsatile devices
Brouwers, Denollet, De Jonge, Caliskan, Young, Pedersen (in press Circ Heart Failure)
CoRPS
LVAD review – continuous-flow devices
CoRPS
Improvement in QoL?
Grady et al. (2002, 2004)
CoRPS
Improvement in QoL?
• 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
CoRPS
QoL pulsatile vs. continuous-flow LVAD
HeartMate II trial
INTERMACS registry
Caused by the improved durability, decrease in complications,
smaller size and silent operation of the continuous-flow device?
No significant difference!
Slaughter et al. (2009) HEARTMATE II TRIAL, Starling et al. (2011) INTERMACS
REGISTRY
CoRPS QoL continuous-flow LVAD - axial and
centrifugal
satisfaction
limitations
* p<0.05
Meyers et al. (2010)
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)
CoRPS
QoL LVAD vs. HTx
Kugler et al. (2010)
CoRPS
QoL LVAD vs. HTx/ healthy controls
CoRPS
Anxiety and Depression in LVAD patients
Cross- sectional!
Retrospective!
Dew et al. (2000), Bunzel et al. (2005)
CoRPS
Anxiety and Depression in LVAD patients
• 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
CoRPS
Anxiety and Depression in LVAD patients vs.
OMT and HTx
*** p<0.001
Rose et al. (2010), Dew et al. (1999)
CoRPS
LVAD review – Limitations and Conclusion
• 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!
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.
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)
CoRPS Methods: Socio-demographic and Clinical
variables
Socio-demographical variables
Clinical variables
• Sex
•
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)
• Employment
•
Comorbidity
• Smoking/ Alcohol
•
ECG
• Participation in rehabilitation
program
•
Echocardiography
•
Hematological levels
•
Excersise capacity test
•
Medication (HF/psychotropic medication)
•
Complications/mortality/ HTx
• Age
• Marital status
• Education
• Under treatment by
psychologist/psychiatrist
CoRPS
Methods: Psychological measures
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
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?
CoRPS Project Participants
CoRPS - Center of Research on
Psychology in Somatic Diseases,
Tilburg University
Prof. dr. Susanne S. Pedersen (PhD)
University Medical Center Utrecht
Prof. dr. Jaap Lahpor (MD, PhD)
Dr. Nicolaas de Jonge (MD, PhD)
Prof. dr. Johan Denollet (PhD)
Drs. Corline Brouwers (Msc)
Erasmus Medical Center Rotterdam
Dr. Kadir Caliskan (MD)
St. Paul’s Hospital, Vancouver,
Canada
Annemarie Kaan
Dr. Quincy Young (PhD)
Dr. Aggie Balk (MD)
Dr. Lex Maat (MD)
CoRPS
Contact details
Prof. dr. Susanne S. Pedersen
Phone: + 31 (0) 13 466 2503
E-mail: [email protected]
CoRPS - Center of Research on Psychology in Somatic diseases, Tilburg
University, The Netherlands
www.tilburguniversity.nl/corps