1. A Canadian View on Effective Use of VADS 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;

2. Disclosures Research grant: St-Jude Medical, Sorin inc. Adboard: Pfizer Speaker bureau – Abbot Vascular – Thoratec – Pfizer – Servier 2

3. USA versus Canada USA Canada

4. About Canada What’s relevant for this audience? Land area: 3,855,100 sq mi (2 nd 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”

5. VAD survival (“DT”) compared to Optimal Medical Therapy (IM 3) Park SJ. AHA Scientific Sessions, November 2010.

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

7. First, the administration ProvincialMinistry of Health Dr Ducharme, minister

8. The publicly funded cardiology evaluation unit from INESSS conducted a reviewThe publicly funded cardiology evaluation unit from INESSS conducted a review of the evidence, of the evidence, carefully monitored not limited to 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

9. 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.

10. Patient characteristics at implant: Québec vs INTERMACS Québec (2010-2012) N=53 % INTERMACS* (2010-2011) N=3,573 % Age group, years ≤ 391312 40 - 595341 60 - 793446 80+00.6 Male7778 † Mean body mass index, kg/m 2 25.727.0 ‡ Mean body surface area, m 2 1.92.07 † * 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.

11. 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

12. 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

13. 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 support57 Died on LVAD support1718 Transplanted after LVAD and alive19 24 Transplanted after LVAD and died6 LVAD explanted / recovery21 * Quarterly Statistical Report 2012; 4rd Quarter; Implant and event dates: June 23, 2006 to December 31, 2012

14. 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 malfunction1314 Bleeding4238 Infection4340 Cardiac arrhythmia 4726 Right heart failure LLE & high CVP post-op (4) LLE & high CVP post-op (4)251714 Neurological dysfunction excluding delirium: excluding delirium:2818,516 Renal dysfunction 2612 Hepatic dysfunction95 Respiratory failure1918 *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

15. 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 > 1 week at any time after LVAD implantation or 2of the 4 clinical criteria; – CVP> 18 – Cardiac index < 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 > 5

16. Total/average cost of hospital stay for LVAD implantation according to costing component (2013 $CAN) Total/average cost of hospital stay for LVAD implantation according to costing component (2013 $CAN) Costing componentTotal costAverage 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

17. 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. 17

18. As for DT… 18 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…

19. USA vs Canada: The Reality ? USA Canada