Update on Mechanical Circulatory Support AATS May 5, 2010 Toronto, ON Canada
Disclosures NONE
Emergency Circulatory Support ECMO Tandem Heart Impella
Assessment Cardiac Function Pulmonary function Valvular function Recovery likely?
ECMO Flow rate : 0 5 L/min Percutaneous or open Versatile : R / L Support Allows for easier patient transportation
SURVIVAL 100 80 % 60 40 20 Cardiac failure Respiratory failure 24% 0 1 2 3 4 5 Years
RISK FACTORS Advancing age Subsystem dysfunction Thoracic aorta operation Reoperation
LIKELIHOOD OF WITHDRAWAL Pre-ECMO factors Advancing age Subsystem dysfunction No IABP + On-ECMO factors Complications on ECMO
Cumulative Survival Freedom from death of any cause after extracorporeal membrane oxygenation implantation for postcardiotomy cardiogenic shock 1.0 0.8 0.6 0.4 0.2 0 0 1 2 3 4 5 6 7 8 9 10 11 Follow-up (y) Rastan et al: JTCS: Feb 2010
ECMO for PCCS:2010 16% 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
IMPELLA
Impella Technology Peripheral Insertion Platforms Impella 5.0 Impella 2.5 HCS-P109-051109-M1
Impella 2.5 or 5.0 Miniaturized Blood Pump Technology 21 Fr micro-axial pump 9 Fr catheter-based platform Delivers up to 2.5-5 L/min blood flow support Minimally Invasive Peripheral Placement 9 Fr catheter-based platform Single peripheral insertion point Femoral Artery Cut-down HCS-P109-051109-M1
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 2008 11 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
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
TandemHeart
Left Sided Support
Feasibility study of a temporary percutaneous LVAD in cardiac surgery Pitsis et al Ann Thorac Surgery 2007 11 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
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
Narrowing the Field-2006-2010 1980 s 1990 s and 2000 s
Narrowing the Field-2010 Heartware HM II BTT:DT Debakey/HeartAssist 5 Duraheart BTT;submitted DT Levacor:BTT Jarvik
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
DT and BTT (Including BTT CAP) Percent Survival 100 BTT (first 133 HM II patients) 1 90 80 70 60 50 40 30 20 10 0 1 Miller, Pagani, Russell et al NEJM 2007 2 Pagani, Miller, Russell et al JACC 2009 3 Slaughter, Rogers, Milano et al NEJM 2009 BTT (first 133 + 148 =281 HM II patients) 2 73% 68% 0 6 12 18 24 Months 58% DT (first 133 HM II Patients) 3
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
% Survival 100 Primary LVADs (n=1,092) intermacs: June 2006 March 2009 80 60 40 Continuous flow pump n=548, deaths=51 Pulsatile pump n=406, deaths=95 20 p<.0001 0 0 2 4 6 8 10 12 Months after Device Implant Kirklin et al: JHLT, January 2010
100 80 Survival on MCS Continuous Flow % 60 40 Pulsatile 20 p=.02 0 2 4 6 8 10 12 Months
Actuarial Survival vs REMATCH* HeartMate II Destination Therapy Trial Percent Survival 100 90 80 70 60 50 40 30 20 10 0 68% CF LVAD 58% 55% 52% LVAD REMATCH: 23% 25% PF LVAD 24% OMM REMATCH 8% 0 6 12 18 24 Months * N Engl J Med 2001; 345:1435-43
% Survival Device Strategy at Implant intermacs: June 2006 March 2009 100 80 BTT=496, deaths=54 BTC=458, deaths=92 60 DT=100, deaths=39 40 20 Primary LVAD n=1,092 p<.0001 0 0 3 6 9 12 15 18 21 24 Months after Device Implant Kirklin et al: JHLT, January 2010
Proportion of Patients Destination Therapy Competing Outcomes intermacs: June 2006 March 2009 1.0 0.8 0.6 Alive 55% device in place Primary LVAD DT: n=100 0.4 0.2 Death 35% before Tx Transplant 10% Explant 0% recovery 0 0 3 6 9 12 15 18 Months after Device Implant Kirklin et al: JHLT, January 2010
RV Dysfunction: Often ignored
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
Survival to Transplantation 100 p=0.001 80 p=0.054 p=0.106 % 60 40 20 0 LVAD P-BiVAD D-BiVAD Fitzpatrick et al, JTCS: April 2009
Survival to Hospital Discharge 100 P<0.0001 80 p=0.002 p=0.046 % 60 40 20 0 LVAD P-BiVAD D-BiVAD Fitzpatrick et al, JTCS: April 2009
Survival Distribution Function 100 80 % 60 40 20 LVAD P-BiVAD D-BiVAD 0 0 500 1000 1500 2000 2500 3000 3500 Survival Time (days) Fitzpatrick et al, JTCS: April 2009
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
2 21 French Transseptal Catheters
% Survival Survival by Device Type intermacs: June 2006 March 2009 (n=1,420) 100 80 60 40 TAH n=51, deaths=10 Bi-VAD n=193, deaths=66 LVAD n=1158, deaths=209 20 RVAD n=18, deaths=3 p (overall) <.0001 0 0 3 6 9 12 15 18 21 24 Months after Device Implant Kirklin et al: JHLT, January 2010
OUTCOMES: PATIENT RISK PROFILE PERSPECTIVE
% Survival 100 90 80 70 60 50 40 30 20 10 p =.002 Event: Death (censored at transplant) Levels 2-7: All Others, n=234, deaths=49 Level 1 (Critical Cardiogenic Shock), n=186, deaths=55 0 0 1 2 3 4 5 6 7 8 9 10 11 12 Months after Device Implant Implant Dates: Jun 23, 2006 Dec 31, 2007 Patient Survival Among Profiles
Sequence of Devices ECMO LVAD RVAD BIVAD TAH 1 st 89 360 3 17 13 2 nd 15 85 18 12 2 3 rd 13 4 6 0 0 4 th 1 0 0 0 0
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 2 1 68 5 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
100 Survival on MCS Device Number % 80 60 40 20 1 2 3 0 2 4 6 8 10 12 Months
Risk Factors for Death on MCS Early phase More devices Cachexia Pre MCS higher BUN Devices other than LVAD
Risk Factors for Death on MCS Constant Hazard More Devices Pre MCS HTN Pre MCS Dialysis Pre MCS ventilatory support Neuro events on MCS
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 <0.0001 1.55 0.0005 Bilirubin (higher) 1.41 0.0002 -- -- RA pressure (higher) 2.08 0.0009 -- -- Cardiogenic shock 1.97 0.02 -- -- BTC or DT -- -- 1.80 0.02 Pulsatile pump -- -- 2.74 0.001 Kirklin et al: JHLT, January 2010
# of Patients Survival (%) Columbia 40 100 High Risk (n=3) 30 80 60 Low Risk (n=83) 20 10 High Risk (score >5) (n=3) 40 20 0 0 0 2 4 6 8 10 0 3 6 9 12 Risk Score Months Schaffer et al, Ann Thorac Surg: 2009
# of Patients Survival (%) Leitz-Miller 10 8 100 80 High Risk (n=33) 6 4 High Risk (score >17) (n=33) 60 40 Low Risk (n=53) 2 20 0 0 0 5 10 15 20 25 0 3 6 9 12 Risk Score Months Schaffer et al, Ann Thorac Surg: 2009
# of Patients Survival (%) INTERMACS 30 100 80 Low Risk (n=43) 20 High Risk (score >2) (n=43) 60 40 High Risk (n=43) 10 20 0 0 0 2 4 6 0 3 6 9 12 Risk Score Months Schaffer et al, Ann Thorac Surg: 2009
# of Patients Survival (%) SHFM-HM II 15 High Risk (score >3.533) (n=31) 100 80 Low Risk (n=55) 10 60 5 40 20 High Risk (n=31) 0 0 2 4 6 Risk Score 0 0 3 6 9 12 Months Schaffer et al, Ann Thorac Surg: 2009
300 Preoperative MELD Score vs TBPE TBPE (units) 200 100 0 10 MELD 20 30 Matthews et al, Circulation: Jan 2010
MCS Fewer devices Select one or two that works for you Increased selectivity of cases Increase value added for expensive technology-reduced morbidity.
Feasibility study of the use of Tandem Heart percutaneous VAD for Treatment of cardiogenic shock Burhoff et al Cath Cardiovasc Interv 2006 13 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
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 2008 18 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%
The TandemHeart as a Bridge to a Long-Term Axial-Flow LVAD Gregoric et al Texas Heart Inst 2008 9 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
Clinical Experience with the TandemHeart Percutaneous VAD as a Bridge to Cardiac Transplantation Bruckner et al Tex Heart Inst J 2008 5 heart failure patients 2 NICM 3 ICM Mean duration of support : 7.6 days (+/- 3.2 days) All successfully BTT
Usefulness of percutaneous LVAD as a bridge to recovery from myocarditis Chandra et al Am J Cardiol 2007 3 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
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)
Left Ventricular Mechanical Support with the Impella Recover Left Direct Microaxial Blood Pump: A Single Center Experience Garati et al Artif Organs 2006 12 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
Initial experiences with the Impella device in patients with cardiogenic shock Impella support for cardiogenic shock Meyns et al Thorac Cardiovasc Surg 2003 16 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
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%