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 d’excellence en santé et en services sociaux, (INESSS),

Montréal, Québec, Canada;

Disclosures

• Research grant: St-Jude Medical, Sorin inc. • Adboard: Pfizer • Speaker bureau

– Abbot Vascular – Thoratec – Pfizer – Servier

2

USA versus Canada

USA Canada

About Canada What’s 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”

VAD survival (“DT”) compared to Optimal Medical Therapy (IM 3)

Park SJ. AHA Scientific Sessions, November 2010.

So we had to open up the bank somehow to offer this therapy to a growing number of patients.

• 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

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.

Patient characteristics at implant: Québec vs INTERMACS

Québec

(2010-2012) N=53

%

INTERMACS* (2010-2011)

N=3,573 %

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; 31:117-26. ‡Teuteberg et al. JACC Heart Failure 2013;1;5:369-78.

51

30

118

0

25

36 37

0.4 0.70

10

20

30

40

50

60

BTT BTC DT Rescue therapy Bridge torecovery

Perc

ent (

%)

Québec

INTERMACS

N=53 Québec (2010-2012) N=3,573 INTERMACS (2010-2011)*

Initial LVAD implant strategy: Québec vs INTERMACS

*Quarterly Statistical Report 2013; 3rd Quarter; Implant and event dates: June 23, 2006 to Sept 30, 2013

13

40

43

4

0 0 0

15

40

27

13

3 2 10

10

20

30

40

50

60

1 2 3 4 5 6 7

Perc

ent (

%)

Québec

INTERMACS

N=53 Québec (2010-2012) N=3,573 INTERMACS (2010-2011)*

INTERMACS clinical profile at time of LVAD implant: Quebec vs INTERMACS

*Quarterly Statistical Report 2013; 3rd Quarter; Implant and event dates: June 23, 2006 to Sept 30, 2013

Clinical results at 1 year after LVAD implant: Québec vs INTERMACS

Québec (2010-2012)

N=53 %

INTERMACS * (2006-2012)

N=6,609 %

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

LVAD explanted / recovery 2 1

*Quarterly Statistical Report 2012; 4rd Quarter; Implant and event dates: June 23, 2006 to December 31, 2012

Adverse events during the first year after implant: Quebec vs INTERMACS

Adverse events Québec (2010-12)

N=53 , % INTERMACS (2006-12)*

N=6,796, %

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 *Quarterly Statistical Report 2012; 4th Quarter; Implant and event dates: June 23, 2006 to December 31, 2012

RVAD/inotrope > 1 week post-op or 2/4 criteria; – CVP> 18 – CI < 2.3 – Ascites/edema –↑ CVP by Echo

TIA or CVA or Seizure or

Encephalopathy or Confusion

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

Excluding: physicians fees, VAD program structure & staff Devices-related rehospitalization

160,652.46 USD

A Canadian View on Effective Use of VADS Conclusion

• 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…

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• We owe to our patients not to miss the boat – Our volumes will increase, but will remain << 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…

USA vs Canada: The Reality ?

USA Canada