Mechanical Circulatory Support for Unstable Heart Failure
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1 Mechanical Circulatory Support for Unstable Heart Failure Michael A. Acker, MD William Measey Professor of Surgery Chief of Cardiovascular Surgery University of Pennsylvania Health System
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9 O.H. Frazier, M.D. Presented on March 6, 2011
10 O.H. Frazier, M.D. Presented on March 6, 2011
11 O.H. Frazier, M.D. Presented on March 6, 2011
12 O.H. Frazier, M.D. Presented on March 6, 2011
13 O.H. Frazier, M.D. Presented on March 6, 2011
14 Indications for VAD Support Bridge to transplant Bridge to Decision Established therapy Mandatory for any center performing transplantation Bridge to recovery Controversial (excluding post-cardiotomy failure, post MI, fulminant acute myocarditis) Permanent/destination therapy Represents the future
15 Biomedicus ECMO Levotronics Impella -2.5/5.0 Tandem Heart Short Term VADs Percutaneous LVAD,RVAD Thoratec PVAD short to long term Abiomed BVS AB5000 (short to long term) Impella (percutaneous) Primary Indications: Post - Cardiotomy Shock Post HTx Complications Post AMI Cardiogenic Shock Fulminant Acute Myocarditis Primary Goal: Bridge to Recovery Bridge to Decision Bridge to Bridge
16 Cardiogenic Shock BVAD vs LVAD(perc vs open) vs ECMO Neuro status unknown Profound pulmonary failure Recent use of thrombolytics ECMO Post cardiotomy often easiest if lungs/rv questionable Profound Shock BVAD Profound shock with MSOF Intractabble VT/VF RV infarct Severe RV dysfunction (high CVP with low PAP) LVAD alone if no evidence of MSOF/severe RVF Perc Tandem for acute MI as bridge Impella 5.0 for dilated heart as bridge Division of Cardiothoracic Surgery University of Pennsylvania
17 LVAD/RVAD/BVAD Short or longterm extraccorporeal Mult cannulations Mod invasivie Ambulation/home PVAD
18 CentriMag Ventricular Assist Technology: First Disposable MagLev VAD Controller & Motor Blood Pump
19 Cardiogenic Shock (Bridge to Decision) Early MCS key-prior to development of MSOF Post MI; Fulminant myocarditis Is the LV/RV recoverable? Acute MI; Fulminant myocarditis How long is support anticipated? Are adjuvant procedures needed? CAB; repair of valve etc Is the pt a potential transplant candidate? Intracorporeal vs Extracorporeal? Can we get the patient home? Bridge to Bridge: ECMO:Tandem; Impella Acute pvad Semi elective--intracorporeal Division of Cardiothoracic Surgery University of Pennsylvania
20 VADS for Cardiogenic Shock Acute MI Change in the treatment paradigm of CS-AMI unresponsive to standard treatment Early LVAD implantation BVADs/ECMO for profound shock; VT; severe RV dysfunction Bridge to Decision Tandem Heart Transplant Recovery Destination Apical cannulation in CS-AMI is safe and effective Percutaneous LVADs RVADs ECMO Tandem Heart acute MI bridge to bridge Impella 5.0 dilated LV- bridge to bridge Impella
21 VENTRICULAR ASSIST DEVICES VAD PUMPS DISPLACEMENT PUMPS ROTARY PUMPS 1 st GEN, perc lead 1 st GEN, totally implantable Next GEN, reduced size Miniature Mechanica l Blood Bearings (Axial) Fluid Film Hydrodyna mic Bearings (Centrifugal ) 2 nd generation 3 rd generation Bearingles s Magnetic Levitation (Axia l) (Centrifu 4 th generation
22 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 Pulsatile-flow LVAD (HM XVE) Large size Noisy Large percutaneous lead Limited durability
23 Actuarial Survival vs REMATCH* Percent Survival XVE - 25% 80index mortality - 45 days index LOS 70 - Months for rehab - Fails in 15 months!! % CF LVAD 58% 55% 52% LVAD REMATCH: 23% 25% PF LVAD 24% OMM REMATCH 8% Months * N Engl J Med 2001; 345: Slaughter M et al. NEJM 2009; 361: 1-11.
24 Glass Half Empty: First Generation LVAD Limitations By 2 years benefit largely gone Large operation with significant Morbidity Infection (30-50%) Stroke Bleeding Large footprint requires BSA >1.5; not suitable for many woman and children Not totally intracorporeal; large percutaneous driveline Limited long-term durability (1-3 yrs) Heartmate < Novacor Persistent low but significant CVA incidence Novacor > HeartMate
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 Pulsatile-flow LVAD (HM XVE) Large size Noisy Large percutaneous lead Limited durability
26 Evolution of Rotary VADs 2 nd Generation Axial flow pump (10,000 rpm) Mechanical blood washed bearings 3 rd Generation Centrifugal flow pump (2 3,000 rpm) Blood film (generated by spinning rotor) is required to suspend rotor (hydrodynamic bearing), magnetic force for alignment only 4 th Generation Centrifugal flow pump (2 3,000 rpm) Total magnetic levitation of rotor (not dependent on contact, blood film, or spinning of the rotor) Jarvik HVAD Levacor HeartMate II CorAide HeartMate III
27 Continuous flow pumps Afterload sensitive Increased afterload = lower output Lower afterload = higher output Preload insensitive Flow estimation poor Algorithms for automatic adjustment of flow not available Suck down possible rpms adjusted not to maximally unload ventricle Limited adjustment to changes in preload If pump fails significant backflow possible?anticoagulation Needed
28 Technology Comparison Rotary Flow Valveless High reliability Axial Flow Small, quiet Flow range: 2-12 L/min Linear H-Q relationship Hydrodynamic Bearing Long life 5 yrs Centrifugal Small, quiet Flow range: 2-12 L/min Flat H-Q curve-esp sensitive to pressure changes-with exercise and no change in pressure will pump more vol and have greater pulsatility Non-wearing impeller Very long life 10yrs
29 HeartMate II Initial Results (n=133) NEJM 2007;357:
30 Increasing Survival with HM II in BTT Implantable Pump Percutaneous Lead Controller Batteries Randall C. Starling, J. Am Coll Cardiol. May
31 Primary Endpoint HeartMate II Destination Clinical Trial Survival at 24 months, free from disabling stroke or re-operation for device replacement (intention-to-treat) Primary Composite Endpoint (% of Patients) Hazard Ratios [95% CI] Percent of Patients /134 (46%) P< /66 (11%) Primary Endpoint Components: Reoperation to Replace Device 13 (10%) vs 24 (36%) Death < 2 years 44 (33%) vs 27 (41%) Disabling Stroke 15 (11%) vs 8 (12%) P<0.001 P<0.001 P=0.048 P=0.56 CF LVAD PF LVAD Favors CF LVAD Favors PF LVAD
32 Actuarial Survival vs REMATCH* HeartMate II Destination Therapy Trial Percent Survival LVAD MEDICAL THERAPY 68% 55% 52% 25% Months CF LVAD** OMM REMATCH 58% LVAD REMATCH: 23% PF LVAD 24% 8% N Engl J Med 2001; 345: N Engl J Med 2009; 361:
33 Adverse Events HeartMate II Destination Therapy Trial CF LVAD (n=133) [211 pt-years] Events/pt yr PF LVAD (n=59) [41 pt-years] Events/pt yr Risk Ratio [95% Confidence Interval] p-value Pump Replacements <0.001 Stroke Ischemic Hemorrhagic Device-related infection Local non-device infection Sepsis <0.001 Bleeding Bleeding requiring PRBC Bleeding requiring surgery Other Neurological Right Heart Failure Extended Inotropes <0.001 RVAD Cardiac Arrhythmias Respiratory Failure <0.001 Renal Failure <0.001 Hepatic Dysfunction Device Thrombosis Re-hospitalizations Favors CF LVAD Favors PF LVAD
34 HeartMate II Clinical Trial Reduction in Adverse Events Nearly 90% reduction in percutaneous lead infection; no pocket infections Nearly 40% reduction in bleeding requiring surgery More than 50% reduction in stroke Nearly 60% reduction in non-stroke neurological event No failures of electromechanical pump mechanism
35 Long-term mechanical circulatory support (destination therapy): On track to compete with heart transplantation? J Thorac Cardiovasc Surg 2012;144:
36 Long-term mechanical circulatory support (destination therapy): On track to compete with heart transplantation? J Thorac Cardiovasc Surg 2012;144:
37 Stable Survival with HM II in DT
38 % Survival Survival in Destination Therapy : Data from LVAD* Destination Therapy, n=1287 (June 2006-Dec 2011) Pulsatile Flow: n=127, deaths=66 Continuous Flow: n=1160, deaths=248 Months % Survival Post implant Pulsatile Continuous 6 74% 84% 12 68% 76% 24 45% 67% Event: Death (censored at Transplant and Explant due to Recovery) Months Post Implant P < James Kirklin, J. Thorac Cardiovasc Surg May 2012
39 100 % Freedom from Device Event Survival Without Device Exchange or Malfunction: LVAD* Destination Therapy, n=1287 (June 2006-Dec 2011) Pulsatile Flow Pumps N=127, device events=25 Months % Freedom from Device Event Post implant CFP PFP 6 99% 96% 12 96% 83% 24 94% 51% CFP: Hazard PFP: Hazard Event: Device Event (Device Exchange or Death due to device malfunction) Months Post Implant Continuous Flow Pumps N=1160, device events = 33 James Kirklin, J. Thorac Cardiovasc Surg May 2012 Death/Months (Hazard)
40 Clinically Proven Bearing Technology > 10,000 HeartMate II implanted since 2004 with no bearing failures or wear-out Clinical durability experience: Support 1 year: 2110 Support 2 years: 728 Support 3 years: 243 Support 4 years: 62 Support 5 years: 17 Support 6 years: 1 Estimated Bearing life: >17 years w/3x safety margin 4 year implant bearings
41 Blood Pump Technology Blood Pumps Pulsatile Rotary TAH Thoratec PVAD HeartMate XVE WorldHeart, Novacor Arrow LionHeart Thoratec IVAD AbioMed, AB5000 Berlin Heart EXCOR Medos HIA WorldHeart, HeartSaver Axial Centrifugal MicroMed DeBakey* VentraCor, VentrAssist Berlin Heart INCOR HeartMate III Jarvik Terumo, DuraHeart HeartMate II HeartWare Circulite WorldHeart/Levacor Impella Arrow, CorAide Levotronics Tandem Heart White font = FDA/CE Orange font = CE Mark(* US clinical trial) Black font = in clinical trials Yellow font = R or D phase Red font -No longer available Abiomed, AbioCor CardioWest
42 Survival with HVAD in BTT Keith D. Aaronson, Circulation May 2012
43 Pericardial Placement Advances Therapy HeartMate XVE HeartMate II HVAD Pump Thoratec HeartMate XVE Thoratec HeartMate II CAUTION: Investigational device. Limited by United States law to investigational use. HeartWare HVAD Pump
44 Pericardial Placement a Key Advantage No abdominal surgery No pump pocket 3 step implant technique Low blood loss Potential for short CPB time CAUTION: Investigational device. Limited by United States law to investigational use.
45 LVADs for BTT/DT Continuous flow devices smaller; safer; less complications; less morbid; longer freedom for device failure; increase QOL HMII approved for DT and BT 30-40% of tx pts BTT Heartware approved for BTT DT trial underway Jarvik/DuraHeart/EvaHeart//Circulite- clinical trial
46 MCS for Destination Therapy CMS Patient Selection Criteria (REMATCH Criteria) Not a Tx candidate Class IV Heart Failure on maximal medical therapy > 60/90 days; EF < 25% Peak VO2<12
47 Contraindications for DT Expected non cardiac survival < 2 yrs Debilitating stroke Irreversible end organ failure Severe COPD Caridac cachexia
48 Other considerations for DT Psychiatric disorders Drug abuse Lack of sound social support that affects ability to care for LVAD at home
49 VAD Patient Selection: Targeting a Viable Population for DT Andrew Boyle, MD Presented on March 5, 2011
50 The Right Time for LVAD Implantation Perfect Window Operative Risk Too early Clinical severity heart failure Too late Right heart failure End-organ dysfunction Worsening nutrition
51 Destination Therapy Risk Score For In-Hospital Death Patient Characteristics Hazard Ratio PLT /µl 7 Albumin 3.3 g/dl 5 INR > Vasodilator therapy 4 MPAP 25 mmhg 3 AST > 45 U/mL 2 HCT 34 % 2 BUN> 51 U/dL 2 No intravenous inotropes 2 Lietz et al. Circulation. 2007;116(5):497 Risk Score=
52 DT Risk Score HMII Survival
53 INTERMACS PATIENT PROFILE/STATUS 1: Critical cardiogenic shock 2: Progressive decline 3: Stable but inotrope dependent 4: recurrent decompensation 5: comfortable at rest but are exercise intolerant for most activity 6: able to do some mild activity, but fatigue results within minutes with meaningful physical exertion. 7: NYHA Class IIIB LVADs
54 Change in DT Patient Profile Over Time Long-term mechanical circulatory support (destination therapy): On track to compete with heart transplantation? J Thorac Cardiovasc Surg 2012;144:
55 Survival to D/C Based on INTERMACS Group 3 vs Group 1: p = 0.02 % survival Group 3 vs Group 2: p = 0.59 Group 2 vs Group 1: p < Group 1 (n=27) Group 2 (n=48) Group 3 (n=24) Group 1: INTERMACS 1: crash and burn Group 2: INTERMACS 2 and 3: hospitalized and inotrope-dependent Group 3: INTERMACS 4 7: poor functional capacity Boyle A, et al. JHLT 2011; accepted for publication. Andrew Boyle, MD Presented on March 5, 2011
56 Lengths of Stay Based on INTERMACS 60 Days Group 3 vs Group 1: p < Group 3 vs Group 2: p < Group 2 vs Group 1: p = Group 1 (n=27) Group 2 (n=48) Group 3 (n=24) Group 1: INTERMACS 1: crash and burn Group 2: INTERMACS 2 and 3: hospitalized and inotrope-dependent Group 3: INTERMACS 4 7: poor functional capacity Boyle A, et al. JHLT 2011; accepted for publication. Andrew Boyle, MD Presented on March 5, 2011
57 Actuarial Survival on MCS Survival (%) Group 3 vs 1: p = Group 3 vs 2: p = Group 2 vs 1: p = Months post-lvad Group 1 Group 2 Group 3 Boyle A, et al. JHLT 2011; accepted for publication. Andrew Boyle, MD Presented on March 5, 2011
58 Long-term mechanical circulatory support (destination therapy): On track to compete with heart transplantation? J Thorac Cardiovasc Surg 2012;144:
59 n=1287, deaths= < Level 60 yrs: 3-7: n=352, n=613, deaths=70 deaths= Months Level 2: yrs: n=435, n=416, deaths=106 deaths= Post implant 70+ Level yrs: 1: n=392, n=112, % Survival deaths=78 deaths=32 40 P P = = % % % Event: Death (censored at Transplant and Explant due to Recovery) % Survival :Survival in Destination Therapy Who is at Risk LVAD* Destination Therapy, n=1287 Months Post Implant Death/Months (Hazard) James Kirklin, J. Thorac Cardiovasc Surg May 2012
60 Current Outcome in DT 6MW and QOL Park S J et al. Circ Heart Fail 2012;5:
61 Current Outcome in DT Adverse Events Adapted from Park S J et al. Circ Heart Fail 2012;5: Early Trial (n=133; 211 Patient-Years) Mid Trial (n=281; Patient-Years) Adverse Event Patients n( %) Events n (Event Rate) Patients n (%) Events n (Event Rate) Risk Ratios P Value Bleeding (PRBC) Bleeding (reexploration) Non Device related Infx Device-related Infection Right heart failure * Ischemic stroke Hemorrhagic stroke 108 (81) 349 (1.66) 207 (74) 565 (1.13) 0.69 < (30) 49 (0.23) 55 (20) 68 (0.14) (49) 160 (0.76) 126 (45) 244 (0.49) 0.65 < (35) 100 (0.47) 84 (30) 133 (0.27) 0.56 < (23) 34 (0.16) 58 (21) 66 (0.13) (8) 12 (0.06) 22 (8) 23 (0.05) (11) 15 (0.07) 13 (5) 14 (0.03)
62 ROADMAP Thoratec sponsored study with HeartMate II Broaden patient selection strategies in underserved but approved populations Non-randomized, multicenter observational study of VAD vs medical therapy in ambulatory patients meeting FDA approved indications for use Target population: Ambulatory Class IV without inotropes (Intermacs 4-6) Risk stratification End-points: Mortality, functionality, QoL, crossover, patient preference, economics Joseph G. Rogers, M.D. Presented on March 6, 2011 Duke Heart Center Duke Heart Center
63 Survival of INTERMACS Profile 4-6 Patients after Left Ventricular Assist Device Implant Is Improved Compared to Seattle Heart Failure Model Estimated Survival 4/4/2012 Eckman P et al J Cardiac Failure Thoratec 17: 8S ; (HFSA Corporation 2011) - Confidential
64 NIH REVIVE-IT Trial (REMATCH II) PILOT trial of only 100 patients Class IIIB ( Intermacs 4-7) Randomized 1:1 between OMM vs HeartMate II LVAD 2 yr single primary end point: Survival Multiple secondary end points Also include functional capacity, QOL, Cost Needed to validate mortality estimates for OMM Trial designed to validate risk in OMM
65 Risk Factors for Mortality with HF (Class IIIB) >3 Prompt Referral for Advanced Rx Hospitalization for HF on oral HF therapy Na+ < 136 BUN> 45, Creat>2.5, CrCl< 45 cc/min BNP >4 x s upper limit of normal Diuretic Dose >2.0 mg/kg/day Inability to take ACEI/ARB/BB LVEDD >7.0 VO2 <55% predicted
66 Median Survival Decreases Progressively after Each Hospitalization Impact of Chronic Kidney Disease (CKD) Average age of HF hosp In community = years Medial Survival (years) 1.0 CKD CKD CKD CKD 0.0 1st 2nd 3rd 4th hospitalization hospitalization hospitalization hospitalization (n=14,374) (n=3,358) (n=1,123) (n=417) Setoguchi et al. AHJ 2007
67 Is This Acceptable Risk: Where Lies the Equipoise? Park SJ. AHA Scientific Sessions, November Soon J. Park, Circ Heart Fail. March 2012
68 Small Continuous Flow Pumps: Unanswered Questions Not pre-load sensitive; afterload sensitive Suck down potential ventricular arrythmias LV not fully unloaded RV dysfunction with septal shift Automatic control systems unavailable or untested; limit flow in fixed mode Need for frequent echos (additional expense and time)? Anticoagulation Pump thrombosis?long term affects of decreased pulse on medium size arterioles GI Bleeding-AVMs Hemorrhagic Strokes?Longterm AI Will Regulatory and Financial Realities allow Field to Reach its Potential
69 CATCH-22 George Weisenthaler: The reason LVAD results are not better is that the cardiologist is only referring pts after one foot is in the grave Donna Mancini: When LVAD results improve then less sick pts will be referred
70 TE 60 y.o w/ LVAD and eventual transplant walked his daughter down the aisle while on the pump. And then attended MaryLou O Hara s wedding as well! Division of Cardiothoracic Surgery, UPHS
71 VADs at Hospital of University of Pennsylvania 50 DT VADS Projected for 2013
72 Therapeutic Strategy Strategic Map of Heart Failure Treatment Class I (1.7M) Class II (1.6M) Class III (1.4M) Class IV (0.36M) DRUGS Medical Treatment REPAIR Surgical Repair NYHA Class III DEVICES AUGMENTATION CRT; girdling devices 25% of HF Patients Frequent hospitalizations ASSIST (Partial support) Rotary VADs Worsening symptoms despite drug therapy Significant opportunity for new therapies REPLACEMENT (Full support) Pulsatile VADs TAH
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