Value Based Care and the Role of INTERMACS in our Evolving Health Care Environment A Canadian View on Effective Use of VADS

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Value Based Care and the Role of INTERMACS in our
Evolving Health Care Environment A Canadian
View on Effective Use of VADS

• Anique Ducharme MD, MSc,
• Montreal Heart Institute, Montreal (Qc), Canada
• AND
• LJ Lambert, G Sas, N Dragieva, LJ Boothroyd, M
  Carrier, R Cecere,
• E Charbonneau, MD, C Sanscartier, AMA, JE Morin,
  MD, P Bogaty, MD
• Institut national dexcellence en santé et en
  services sociaux, (INESSS),
• Montréal, Québec, Canada

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Disclosures

• Research grant St-Jude Medical, Sorin inc.
• Adboard Pfizer
• Speaker bureau
• Abbot Vascular
• Thoratec
• Pfizer
• Servier

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USA versus Canada
USA
Canada
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About CanadaWhats relevant for this audience?

• Land area 3,855,100 sq mi  (2nd largest in the
  world)
• Population  35,158,300,
• Smaller than California (38,041,430)
• Quebec (8, 155 300)
• Canadian Health care system socialized
• Universal access
• HF patients lost leader
• Hospital admission
• No DRG-diagnosis reimbursement
• Devices therapy (ICD-CRT-MCS) more
• No possibility for the hospital to Gain Back
  some of the lost

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VAD survival (DT) compared to Optimal Medical
Therapy (IM 3)
Park SJ. AHA Scientific Sessions, November 2010.
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So we had to open up the bank somehow to offer
this therapy to a growing number of patients.
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First, the administration
Provincial Ministry of Health
Dr Ducharme,
minister
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• The publicly funded cardiology evaluation unit
  from INESSS conducted a review
• of the evidence,

• And recommended to the Québec Ministry of Health
  that use of long-term left ventricular assist
  devices (LVAD) should be carefully monitored but
  not limited to bridge-to-transplant patients.
• March 2012

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A Canadian View on Effective Use of VADS First
the data

• In 2013, many Canadian centers joined CANAMACS
• Data non available yet
• INESSS
• Retrospective review of hospital data sources of
  all LVAD-implanted patients (3 centers) ?
  2010-12.
• Variables, definitions time points as INTERMACS
• Major clinical outcomes (death, transplant,
  recovery) and adverse events were determined
  during 1-year follow up.

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Patient characteristics at implant Québec vs
INTERMACS
Québec (2010-2012) N53 INTERMACS (2010-2011) N3,573
Age group, years
39 13 12
40 - 59 53 41
60 - 79 34 46
80 0 0.6
Male 77 78
Mean body mass index, kg/m2 25.7 27.0
Mean body surface area, m2 1.9 2.07
Quarterly Statistical Report 2013 3rd Quarter
Implant and event dates June 23, 2006 to
September 30, 2013
Kirklin et al. J Heart Lung Transplant 2012
31117-26. Teuteberg et al. JACC Heart Failure
201315369-78.
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Initial LVAD implant strategy Québec vs
INTERMACS
N53 Québec (2010-2012) N3,573 INTERMACS
(2010-2011)
Quarterly Statistical Report 2013 3rd Quarter
Implant and event dates June 23, 2006 to Sept
30, 2013
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INTERMACS clinical profile at time of LVAD
implant Quebec vs INTERMACS
N53 Québec (2010-2012) N3,573 INTERMACS
(2010-2011)
Quarterly Statistical Report 2013 3rd Quarter
Implant and event dates June 23, 2006 to Sept
30, 2013
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Clinical results at 1 year after LVAD implant
Québec vs INTERMACS
Québec (2010-2012) N53 INTERMACS (2006-2012) N6,609
Alive on LVAD support 57 57
Died on LVAD support 17 18
Transplanted after LVAD and alive 19 24
Transplanted after LVAD and died 6 24
LVAD explanted / recovery 2 1
Quarterly Statistical Report 2012 4rd Quarter
Implant and event dates June 23, 2006 to
December 31, 2012
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Adverse events during the first year after
implant Quebec vs INTERMACS
Adverse events Québec (2010-12) N53 , INTERMACS (2006-12) N6,796,
Device malfunction 13 14
Bleeding 42 38
Infection 43 40
Cardiac arrhythmia 47 26
Right heart failure LLE high CVP post-op (4) 25 17 14
Neurological dysfunction excluding delirium 28 18,5 16
Renal dysfunction 26 12
Hepatic dysfunction 9 5
Respiratory failure 19 18

• RVAD/inotrope
• gt 1 week post-op
• or 2/4 criteria
• CVPgt 18
• CI lt 2.3
• Ascites/edema
• ? CVP by Echo

TIA or CVA or Seizure or Encephalopathy or
Confusion
Quarterly Statistical Report 2012 4th Quarter
Implant and event dates June 23, 2006 to
December 31, 2012
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Definitions adverse event

• Cardiac arrhythmia any documented ventricular
  or supra ventricular requiring defibrillation or
  cardioversion or new drug treatment
• Right heart failure RVAD or inotrope for gt 1
  week at any time after LVAD implantation or 2of
  the 4 clinical criteria
• CVPgt 18
• Cardiac index lt 2.3
• Ascites or peripheral edema
• Elevated CVP by Echo
• Neurological dysfunction TIA or CVA or Seizure
  or Encephalopathy or Confusion
• Renal dysfunction
• requiring new dialysis or hemofiltration
• creatinine gt 5

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Total/average cost of hospital stay for LVAD
implantation according to costing component (2013
CAN)
Costing component Total cost Average per patient cost
In-hospital drug cost 246,618 5,075
LVAD implantation cost 300,889 6,269
Hospital stay cost 2,557,486 53,282
LVAD acquisition cost 5,365,534 111,782
Total 8,470 527 176 408
160,652.46 USD
Excluding physicians fees, VAD program
structure staff Devices-related
rehospitalization
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A Canadian View on Effective Use of
VADSConclusion

• Our implant rate is very low
•  US benchmark  30/100 000 population
• Quebec 0.67/100 000
• In comparison with INTERMACS patients, Québec
  LVAD patients are younger but sicker and less
  likely to be DT.
• Despite low volumes, clinical results in Québec
  hospitals are similar to those reported for
  INTERMACS.
• More adverse events reported with independent
  data abstraction compared to self reporting ?
• The cost of initial VAD implant in Canada is
  cheap.

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As for DT

• We owe to our patients not to miss the boat
• Our volumes will increase, but will remain ltlt USA
• Key for a successfull DT program lies in patients
  selection.
• Will future policies affect our capacity to offer
  DT to the Canadian patients?
• Some costs are not expected to drop (hospital,)
• The politicians are getter older also

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USA vs Canada The Reality ?
USA
Canada