Update on Mechanical Circulatory Support. AATS May 5, 2010 Toronto, ON Canada

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Alban Lee
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1 Update on Mechanical Circulatory Support AATS May 5, 2010 Toronto, ON Canada

2 Disclosures NONE

3 Emergency Circulatory Support ECMO Tandem Heart Impella

4 Assessment Cardiac Function Pulmonary function Valvular function Recovery likely?

5 ECMO Flow rate : 0 5 L/min Percutaneous or open Versatile : R / L Support Allows for easier patient transportation

9 SURVIVAL % Cardiac failure Respiratory failure 24% Years

10 RISK FACTORS Advancing age Subsystem dysfunction Thoracic aorta operation Reoperation

11 LIKELIHOOD OF WITHDRAWAL Pre-ECMO factors Advancing age Subsystem dysfunction No IABP + On-ECMO factors Complications on ECMO

12 Cumulative Survival Freedom from death of any cause after extracorporeal membrane oxygenation implantation for postcardiotomy cardiogenic shock Follow-up (y) Rastan et al: JTCS: Feb 2010

13 ECMO for PCCS: % 6 month and 1 year survival Risk factors: Age>70, complex operations, diabetes and pre-op CRI Dialysis-65% Reop-60% Stroke- 17% Blood in 48hrs-30 units +/- 26 Rastan etal JTCVS Feb 2010: Heart Center University of Leipzig

14 IMPELLA

15 Impella Technology Peripheral Insertion Platforms Impella 5.0 Impella 2.5 HCS-P M1

16 Impella 2.5 or 5.0 Miniaturized Blood Pump Technology 21 Fr micro-axial pump 9 Fr catheter-based platform Delivers up to L/min blood flow support Minimally Invasive Peripheral Placement 9 Fr catheter-based platform Single peripheral insertion point Femoral Artery Cut-down HCS-P M1

17 Use of Impella Recover 2.5 LVAD in patients with cardiogenic shock or undergoing high risk PCI: Experience of a High Volume Center Vecchio et al Minerva Cardioloangiol patients 6 cardiogenic shock 5 high risk PCI 7 patients had bleeding (5 with shock) Only 2 patients had significant hemodynamic improvement All PCI patients were discharged Only 2 patients in shock were discharged Conclusion : Impella is feasible and safe but may be insufficient in reversing advance cardiogenic shock which, probably, has to be treated with more powerful LVADs

18 Impella Merits Miniturized Percutaneous Support Uni-ventricular Max support : days LV unloading Bleeding Limitations Limb ischemia Infection with longer support times Need for fluoroscopic support for positioning LD : cumbersome technology

19 TandemHeart

20 Left Sided Support

21 Feasibility study of a temporary percutaneous LVAD in cardiac surgery Pitsis et al Ann Thorac Surgery male patients Post cardiotomy unable to wean from CPB Mean duration of support : 88 hrs Weaning rate : 72% Survival to discharge : 54.5 % 1 year survival : 45% 4 year survival : 36.3 % Main complication was bleeding

22 TandemHeart Merits Miniaturized Percutaneous Support Uni-ventricular Bi-ventricular Max support : 3 weeks LV unloading?? Bleeding Hemolysis Limitations Limb ischemia Infection with longer support times Need of X-ray capability for implantation

23 Narrowing the Field s 1990 s and 2000 s

24 Narrowing the Field-2010 Heartware HM II BTT:DT Debakey/HeartAssist 5 Duraheart BTT;submitted DT Levacor:BTT Jarvik

moving part long term durability Pulsatile-flow LVAD (HM

25 HeartMate II vs HeartMate XVE LVAD Continuous-flow LVAD (HM II) 1/7 size; 1/4 weight Quiet 40% smaller lead One moving part long term durability Pulsatile-flow LVAD (HM XVE) Large size Noisy Large percutaneous lead Limited durability

26 DT and BTT (Including BTT CAP) Percent Survival 100 BTT (first 133 HM II patients) Miller, Pagani, Russell et al NEJM Pagani, Miller, Russell et al JACC Slaughter, Rogers, Milano et al NEJM 2009 BTT (first =281 HM II patients) 2 73% 68% Months 58% DT (first 133 HM II Patients) 3

27 Heartware Kaplan-Meier Survival Curve Clinical Trial Patients (n =50) Commercial Patients (n = 50) 90% 85% 77% 90% 87% 180 days 180 days Data as of Feb 2010 Strueber, et al. ISHLT Annual Meeting 2010

28 % Survival 100 Primary LVADs (n=1,092) intermacs: June 2006 March Continuous flow pump n=548, deaths=51 Pulsatile pump n=406, deaths=95 20 p< Months after Device Implant Kirklin et al: JHLT, January 2010

29 Survival on MCS Continuous Flow % Pulsatile 20 p= Months

30 Actuarial Survival vs REMATCH* HeartMate II Destination Therapy Trial Percent Survival % CF LVAD 58% 55% 52% LVAD REMATCH: 23% 25% PF LVAD 24% OMM REMATCH 8% Months * N Engl J Med 2001; 345:

31 % Survival Device Strategy at Implant intermacs: June 2006 March BTT=496, deaths=54 BTC=458, deaths=92 60 DT=100, deaths= Primary LVAD n=1,092 p< Months after Device Implant Kirklin et al: JHLT, January 2010

32 Proportion of Patients Destination Therapy Competing Outcomes intermacs: June 2006 March Alive 55% device in place Primary LVAD DT: n= Death 35% before Tx Transplant 10% Explant 0% recovery Months after Device Implant Kirklin et al: JHLT, January 2010

33 RV Dysfunction: Often ignored

34 BTT 90% of patients can get by with just an LVAD DT 10-15% of patients continue with RV dysfunction Slide furnished by Thoratec, Inc

35 Survival to Transplantation 100 p= p=0.054 p=0.106 % LVAD P-BiVAD D-BiVAD Fitzpatrick et al, JTCS: April 2009

36 Survival to Hospital Discharge 100 P< p=0.002 p=0.046 % LVAD P-BiVAD D-BiVAD Fitzpatrick et al, JTCS: April 2009

37 Survival Distribution Function % LVAD P-BiVAD D-BiVAD Survival Time (days) Fitzpatrick et al, JTCS: April 2009

38 Predictors of RV dysfunction RVSWI < 600 mm Hg xml/m2 CVP >15 or >PCWP Pre-operative vent support T bili >2.0 Creatinine >2.5 Fevers within 24 hrs

39 2 21 French Transseptal Catheters

40 % Survival Survival by Device Type intermacs: June 2006 March 2009 (n=1,420) TAH n=51, deaths=10 Bi-VAD n=193, deaths=66 LVAD n=1158, deaths= RVAD n=18, deaths=3 p (overall) < Months after Device Implant Kirklin et al: JHLT, January 2010

41 OUTCOMES: PATIENT RISK PROFILE PERSPECTIVE

42 % Survival p =.002 Event: Death (censored at transplant) Levels 2-7: All Others, n=234, deaths=49 Level 1 (Critical Cardiogenic Shock), n=186, deaths= Months after Device Implant Implant Dates: Jun 23, 2006 Dec 31, 2007 Patient Survival Among Profiles

43 Sequence of Devices ECMO LVAD RVAD BIVAD TAH 1 st nd rd th

44 Sequence of MCS Support 1 st 2 nd 3 rd 4 th EHMO LVAD 54 RVAD 1 ECMO RVAD 1 12 LVAD 1 RVAD ECMO BiVAD 12 ECMO RVAD 1 LVAD 17 LVAD 2 2 ECMO LVAD 286 RVAD 13 BiVAD 1 TAH 1 ECMO 1 ECMO LVAD 14 BiVAD 1 3 BiVAD LVAD RVAD BiVAD 2 RVAD TAH 5 TAH

45 100 Survival on MCS Device Number % Months

46 Risk Factors for Death on MCS Early phase More devices Cachexia Pre MCS higher BUN Devices other than LVAD

47 Risk Factors for Death on MCS Constant Hazard More Devices Pre MCS HTN Pre MCS Dialysis Pre MCS ventilatory support Neuro events on MCS

48 Risk Factors for Death after Implant in 1,092 Primary LVADs (INTERMACS: June 2006-March 2009) Early Constant Risk factor HR p-value HR p-value Age (older) 2.42 < Bilirubin (higher) RA pressure (higher) Cardiogenic shock BTC or DT Pulsatile pump Kirklin et al: JHLT, January 2010

49 # of Patients Survival (%) Columbia High Risk (n=3) Low Risk (n=83) High Risk (score >5) (n=3) Risk Score Months Schaffer et al, Ann Thorac Surg: 2009

50 # of Patients Survival (%) Leitz-Miller High Risk (n=33) 6 4 High Risk (score >17) (n=33) Low Risk (n=53) Risk Score Months Schaffer et al, Ann Thorac Surg: 2009

51 # of Patients Survival (%) INTERMACS Low Risk (n=43) 20 High Risk (score >2) (n=43) High Risk (n=43) Risk Score Months Schaffer et al, Ann Thorac Surg: 2009

52 # of Patients Survival (%) SHFM-HM II 15 High Risk (score >3.533) (n=31) Low Risk (n=55) High Risk (n=31) Risk Score Months Schaffer et al, Ann Thorac Surg: 2009

53 300 Preoperative MELD Score vs TBPE TBPE (units) MELD Matthews et al, Circulation: Jan 2010

54 MCS Fewer devices Select one or two that works for you Increased selectivity of cases Increase value added for expensive technology-reduced morbidity.

55 Feasibility study of the use of Tandem Heart percutaneous VAD for Treatment of cardiogenic shock Burhoff et al Cath Cardiovasc Interv patients with cardiogenic shock 6 month follow-up Support duration: 60 +/- 44 hrs 10 (77%) patients survived to device explant 6 (60%) of these bridged to another therapy 7 (53 %) patients survived to hospital discharge 7 (53%) alive at 6 months Two most common complications 3 (23%) distal limb ischemia 4 (30%) bleeding from cannulation site

56 Use of the Percutaneous LVAD in Patients with Severe Refractory Cardiogenic Shock as a Bridge to Long-term LVAD Implantation Idelchick et al J Heart Lung Transpl patients All in persistent cardiogenic shock to IABP and inotropes All were as a bridge to LVAD or heart transplantation Mean duration of support : 4.2 days (+/- 2.5 days) 4 patients terminated support before LVAD 14 successfully bridged to LVAD or Heart Transplantation Complications: Right common femoral artery dissection Blood transfusions in 8 patients Infection with positive b/c in 8 patients 30 day mortality : 27% 6 month mortality : 33%

57 The TandemHeart as a Bridge to a Long-Term Axial-Flow LVAD Gregoric et al Texas Heart Inst end-stage heart failure patients All in acute hemodynamic decompensation Mean age 37 yrs Tandem as a bridge to axial flow pump Days of Tandem : 5.9 days (range 1-22 days) 3 BTT 5 continued on axial flow pump, 1 ( 11%) died after converted to an axial flow pump

58 Clinical Experience with the TandemHeart Percutaneous VAD as a Bridge to Cardiac Transplantation Bruckner et al Tex Heart Inst J heart failure patients 2 NICM 3 ICM Mean duration of support : 7.6 days (+/- 3.2 days) All successfully BTT

59 Usefulness of percutaneous LVAD as a bridge to recovery from myocarditis Chandra et al Am J Cardiol patients with acute myocarditis All in severe cardiogenic shock All successfully bridged to recovery with Tandem Mean duration of support : 5 days (range 2 8 days) All survived to discharge

60 Randomized comparison of intra-aortic balloon support with a percutaneous LVAD in patients with revascularized AMI complicated by cardiogenic shock Thiele et al Eur Heart J 2005 Randomized trial of IABP vs perc VAD Patients in cardiogenic shock following AMI Going for PCI of the occluded vessel IABP, n = 20 and pvad, n = 21 p VAD better in improving cardiac index, hemodynamic and metabolic variables pvad had more severe bleeding (n=19 vs. 8, p=0.002) and more limb ischemia (n = 7 vs. n = 0, p=0.009) 30-day mortality was similar (IABP 45% vs pvad 43%, p = 0.86)

61 Left Ventricular Mechanical Support with the Impella Recover Left Direct Microaxial Blood Pump: A Single Center Experience Garati et al Artif Organs patients 6 supported as BTT 3 treated for fulminant acute myocarditis 3 Post cardiotomy low-output Mean support time : 8.8 days (+/- 2.3 days) Overall mortality : 50% 4 patients were successfully BTT; the 2 other died on the device 2 patients with myocarditis died of septic shock 2 patients with post-cardiotomy syndrome died of MSOF 2 patients were weaned

62 Initial experiences with the Impella device in patients with cardiogenic shock Impella support for cardiogenic shock Meyns et al Thorac Cardiovasc Surg patients in cardiogenic shock 10 post cardiotomy heart failure All placed directly through the aorta 6 in coronary unit Through the femoral 3 patients the device was used in combination with ECMO Device related complications: 3 sensor failures 1 pump displacement 6 incidences of hemolysis 11 patients weaned 6 patients survived

63 A randomized clinical trial to evaluate the safety and efficacy of a percutaneous LVAD versus IABP for treatment of cardiogenic shock caused by MI Seyfarth et al J Am Coll Cardiol 2008 Prospective randomized trial All with cardiogenic shock 25 patients 13 IABP 12 Impella LP 2.5 Impella better at providing hemodynamical support than IABP 30 day mortality for both groups = 46%

DECLARATION OF CONFLICT OF INTEREST

DECLARATION OF CONFLICT OF INTEREST Cardiogenic Shock Mechanical Support Eulàlia Roig FESC Heart Failure and HT Unit Hospital Sant Pau - UAB Barcelona. Spain No conflics of interest Mechanical Circulatory