Low cardiac output & Mechanical Support นายแพทย อรรถภ ม ส ศ ภอรรถ ศ ลยศาสตร ห วใจและทรวงอก โรงพยาบาล ราชว ถ

Transcription

1 Low cardiac output & Mechanical Support นายแพทย อรรถภ ม ส ศ ภอรรถ ศ ลยศาสตร ห วใจและทรวงอก โรงพยาบาล ราชว ถ

2 Low cardiac output/cardiogenic Shock State of end-organ hypoperfusion due to cardiac failure. Hemodynamic parameters: Persistent hypotension (SBP mm Hg or MAP 30 mm Hg lower than baseline) Cardiac index (1.8 L min1 m2 without support or 2.0 to 2.2 L min1 m2 with support) Adequate or elevated filling pressure (eg, LVEDP18 mm Hg or RVEDP mm Hg) Circulation. 2008;117:

3 Etiologies Acute myocardial infarction/ischemia LV failure Papillary muscle/chordal rupture- severe MR Ventricular free wall rupture with subacute tamponade Other conditions complicating large MIs Hemorrhage Infection Excess negative inotropic or vasodilator medications Prior valvular heart disease Hyperglycemia/ketoacidosis Post-cardiac arrest Post-cardiotomy Refractory sustained tachyarrhythmias Acute fulminant myocarditis End-stage cardiomyopathyhypertrophic cardiomyopathy with severe outflow obstruction Aortic dissection with aortic insufficiency or tamponade Pulmonary embolu Severe valvular heart disease -Critical aortic or mitral stenosis, Acute severe aortic or MR

4 Pathophysiology Ann Intern Med. 1999;131:47 59.

5 4 Potential Therapies Pressors Intra-aortic Balloon Pump (IABP) Fibrinolytics Revascularization: CABG/PCI Refractory shock: ventricular assist device, cardiac transplantation

6 Pressors do not change outcome Dopamine <2 renal vascular dilation <2-10 +chronotropic/inotropic (beta effects) >10 vasoconstriction (alpha effects) Dobutamine positive inotrope, vasodilates, arrhythmogenic at higher doses Norepinephrine (Levophed): vasoconstriction, inotropic stimulant. Should only be used for refractory hypotension with dec SVR. Vasopression vasoconstriction VASO and LEVO should only be used as a last resort

7 Intra-aortic balloon pump Percutaneous assist devices Surgical assist devices MECHANICAL CIRCULATORY SUPPORT

8 Intra-Aortic Balloon Pump IABP beneficial effects Easy to implant Improves coronary perfusion Myocardial oxygen supply After-load reduction Improves distal perfusion Reduction of myocardial work Improvement LV performance H Thiele Eur Heart J 2007;28:2057 HR Raynolds Circulation 2008;117:686

9 The Physiology of Counterpulsation Enhanced coronary blood flow Left ventricular unloading Improved cardiac output Diastolic balloon inflation increases intra-aortic pressure and coronary perfusion MAP increases from greater increase in diastolic pressure than reduction of systolic pressure Absolute change in coronary perfusion dependent upon vasoregulation Displacement of blood into the periphery Reduction of SBP Reduction of LVEDP Reduced LV wall stress Reduced LV O2 consumption Preserved or increased stroke volume Increased cardiac output as a result of afterload reduction Rogers, J. Mechanical Devices in Cardiogenic Shock, AHA 2009

10 Indications for IABP Complicated acute myocardial infarction Cardiogenic shock Refractory unstable angina Severe CAD with hemodynamic compromise Mechanical complications of AMI Support of high risk coronary intervention Stabilization of left main disease Induction and weaning of cardiopulmonary bypass Bridge to cardiac transplantation Refractory arrhythmias Surgery for high risk cardiovascular patients

11 Contraindications to IABP Significant aortic regurgitation significant arteriovenous shunting Abdominal aortic aneurysm or aortic dissection Uncontrolled sepsis Uncontrolled bleeding disorder Severe bilateral peripheral vascular disease Bilateral femoral popliteal bypass grafts for severe peripheral vascular disease.

12 Benchmark registry: Indication Total Populatio n (n = 16,909) Diagnostic Catheterizatio n (n = 1576) Catheterization Only & PCI Only (n = 3882) CABG (n = 9179) Surgery Non-CABG (n = 1086) No Interventio n (n = 1186) Support and stabilization (%) Cardiogenic shock (%) Weaning from cardiopulmonary bypass (%) Preop: high risk CABG (%) Refractory unstable angina (%) Refractory ventricular failure (%) Mechanical complication due to AMI (%) Ischemia related to intractable VA (%) Cardiac support for high-risk general surgery (%) Other (%) Intraoperative pulsatile flow (%) Missing indication (%) Ferguson et al. Am Coll Cardiol 2001;38:

13 GUSTO-1(1995), 7% (2,972) of pts had CS and IABP was used in 734 pts with a trend towards decreased mortality at 30 days (47% vs 60%, p=0.06) International Shock Registry (Hochman 1995) enrolled 251 pts with CS and found unadjusted mortality to be lower in the 173 pts treated with IABP (57% vs 72%, p=0.039) SHOCK Trial Registry (Sanborn 2000) looked at 856 pts with LV heart failure and CS, found pts did better with revascularization and IABP when compared with medical management alone (47% vs 77%, p<0.0001) In NRMI-2 Registry (Chen 2003) with n=23,138, 31% of CS was treated with IABP and a substantial mortality benefit (49% vs 67%) was seen when IABP was used in conjunction with reperfusion therapy, especially thrombolysis There was lower overall mortality in pts underwent primary PCI but not influenced by the use of IABP (45% vs 47%)

14 IntraAortic Balloon Pump Guidelines for STEMI complicated with cardiogenic shock support IABP counterpulsation as the method of choice for mechanical assistance F Van der Werf Eur Heart J 2008;29:2909 EM Antman J Am Coll Cardiol 2004;44:761

15 Algorithm for revascularization strategy in cardiogenic shock, from ACC/AHA guidelines. Whether shock onset occurs early or late after MI, rapid IABP placement and angiography are recommended. Copyright American Heart Association Reynolds H R, and Hochman J S Circulation 2008;117:

16 Data from the SHOCK Trial-STEMI and CS Randomized trial comparing ERV with PCI vs MT 185 patients with STEMI and CS were treated with IABP Rapid complete reverse of hypoperfusion (CRH) 30 min after IABP implantation was achieved in 68 pts (37%) 30-day mortality: 25% CRH vs 63% non CRH, (p<0.001) After adjustment for age, LVEF and early revascularization Need for continuous evaluation and if hemodynamic improvement is not achieved at 4-6 hours the implantation of an assist device should be considered H Thiele Eur Heart J 2007;28:2057 K Ramanathan Am Heart J 2011;162:268

17 Meta-analysis of IABP therapy in STEMI and CS 2 separate meta-analysis 7 randomized trial (n=1009) No 30-day survival benefit No improved LVEF Higher stroke and bleeding rates 9 cohorts (n=10529) Pt w thrombolysis- IABP decrease 30 day mortality Pt w PCI-IABP increase 30 day mortality Non-randomized studies IABP may have been preferentially given to patients in worse condition Reflect a longer ischemic time if it was implanted for transfer the patient Sjauw K D et al. Eur Heart J 2009;30:

18 IABP-SHOCK II: Randomized comparison of intraaortic balloon counterpulsation versus optimal medical therapy in addition to early revascularization in acute myocardial infarction complicated by cardiogenic shock Multi-center, open-label, parallel group, randomized, control trial N=600 patients with acute MI complicated by cardiogenic shock IABP (n=301) Control (n=299) 37 centers in Germany Enrollment: Follow-up: 30 days N Engl J Med Oct 4;367(14): IABP showed no improvement in 30-day mortality, blood pressure no reduction in treatment time in the intensive care unit no decrease in the duration or dose of drugs prescribed no improvement in organ perfusion did not induce complications, and was shown to be a safe device.

19 Based upon results from the IABP-SHOCK the new 2012 ESC STEMI guidelines downgraded the use of IABP in STEMI patients from 1C to 2B. And AHA/ACC STEMI 2013 downgraded from 1B to 2A

20 Percutaneous MCS Devices Potential Clinical Utility of Percutaneous VADS Acute cardiogenic shock Chronic decompensated heart failure Post-cardiotomy Hemodynamically assisted high risk coronary interventions Supported percutaneous valve repair/replacement Supported ventricular arrhythmia ablation

21 Percutaneous Mechanical Support TandemHeart pvad Percutaneous insertion 21 F venous cannula passes to left atrium via a transseptal puncture F arterial cannula Centrifugal flow pump that can provide L/min at 7500 RPM Systemic anticoagulation required Approved for short-term support

22 Impella Miniaturized rotary blood pump (axial flow) Provides up to 2.5 (percutaneous) or 5.0 (surgical) L/min at maximum speed of 50,000rpm Inserted retrograde across the aortic valve to unload the LV No extracorporeal blood Required heparin

23 Percutaneous MCS Impella microaxial flow pump TandemHeart Centrifugal pump H Thiele Eur Heart J 2007;28:2057

24 Surgical MCS ECMO: extracorporeal membrane oxygenation External blood pump connected to a membrane oxygenator similar to the cardiopulmonary bypass system used in cardiac surgery Short duration (<1 month) CS associated with severe respiratory insufficiency

25 Surgical MCS Patients on CS are too sick for permanent LVAD. Therefore stabilization using a temporary system is considered the best option In some patients in whom recovery of ventricular function is not expected a longterm VAD can be implanted BiVAD should be considered if there is right ventricular dysfunction VAD should be implanted before irreversible multi-organ failure is present Kirklin JK JHLT 2011;30:115

26 Patient stabilized with MCS Bridge to recovery AMI+Stunning myocardium Fulminant myocarditis Postcardiotomy Bridge to Heart Transplantation No contraindication for HT Non-revascularized AMI Chronic ischemic and non-icm Bridge to long term LVAD or Destination therapy M Slaughter J Heart Lung Transplant 2010 L Lund Eur J Heart Fail 2010;12:434

27 Concerns for VAD implantation Severe aortic insufficiency should be corrected with a bioprosthesis Mechanical aortic valve should be replaced with a bioprosthesis Uncertain neurologic status after surviving a cardiac arrest High risk of bleeding (pre-operative abnormal coagulation) Severe thrombocytopenia (Heparin-induced antibodies) Active sepsis Advanced inflammatory systemic response syndrome (SIRS) Correct evaluation of irreversible end-organ failure is still a challenge Advanced age or severe comorbidities may contraindicate VAD JL Brown Current Treat Options Cardiovasc Med 2011

28 CLINICAL EVIDENCE OF ITS IMPACT ON IMPROVING THE PT S CONDITION

29 Improving Survival with LVAD Therapy

30 Percutaneous VAD: TandemHeart 117 patients with refractory CS, (48%) underwent CP resuscitation Hemodynamic and metabolic parameters B Kar JACC 2011;57:688 Mortality at 30-day was 40%

31 Randomized Trial IABP vs TH 41 AMI and CS IABP 20 pts vs TandemHeart 21 pts 95% of pts underwent primary PCI The primary endpoint was hemodynamic improvement within 2 h after device insertion H Thiele Eur Heart J 2005;26:1276 The median duration of support was not different between the two systems

32 Adverse events comparing IABP and TH IABP VAD-TH p Limb ischemia Transfusion Fresh frozen plasma and platelets Fever IABP mortality 45% TH mortality 43% Despite higher hemodynamic stability with TH, 30-day mortality was not reduced H Thiele Eur Heart J 2005;26:1276

33 ISAR-SHOCK trial: Impella LP 2.5 vs IABP Cardiogenic shock caused by AMI Randomized trial two centers: 25 pts IABP (13) vs Impella (12) implanted after revascularization therapy The primary endpoint was hemodynamic improvement within 30 min after device insertion The increase in CI was greater with the Impella than IABP +0.49±0.46 vs +0.11±0.31 (p=0.002) Serum lactate were lower 6 patients died in each group M Seyfarth J Am Coll Cardiol 2008;52:1584

34 Impella Trials PROTECT II: Prospective, randomized trial of Impella vs IABP in patients undergoing non-emergent high-risk PCI RECOVER II: Prospective, randomized trial of Impella vs IABP in patients with post-mi hemodynamic instability

35 Meta-analysis IABP vs P-AD Randomized studies Despite higher hemodynamic stabilization with PAD, the higher rate of complications and the presence of more advanced inflammatory syndrome might explain the lack of improvement in 30-day mortality Cheng JM Eur Heart J 2009;30:2108

36 Surgical LVAD/HT Retrospective study of 130 pts with STEMI and cardiogenic shock All treated with inotropics and IABP 43 pts conservative therapy 95 pts aggressive therapy: 77 pts PCI (47%) or CABG (43%) 18 (19%) LVAD/HT (ECMO+LVAD 14, 1 LVAD, primary HT 3) In-hospital mortality 5-year mortality W Tayara L Heart Lung Transplant 2006;25:504 BTT was successful in 72%

37 BiVAD as a bridge to HT in CS Retrospective study of 80 patients, All were in critical CS with emergency implantation of bivad Alive(71%) Death(29%) BTT was successful in 57 pts (71%) 20 pts (87%) died of MODS J Morigushi J Heart Lung Transplant 2011

38 So, Which device for my patient? Amount of support needed? Impella5.0, TandemHeart> Impella2.5> IABP Duration of support? Other issues (e.g., PVD, active bleeding) Local expertise?

39 Chronic end-stage HF Acute Cardiogenic shock Long-term VAD Cardiopulmonary failure? BVAD/ATH Sustained VT, multiorgan dysfunction, or RV failure Contraindication to transplant? LVAD ECMO Cardiac recovery? Isolated pulmonary recovery Short-term VAD Sustained VT, multiorgan dysfunction, or RV failure BTT Syncardia TAH Thoratec PVAD DT Abiocor TAH DT Thoratec devices Investigational devices BTT Thoratec devices Investigational devices Device Explantation BVAD TandemHeart CentriMag Biomedicus Abiomed VADs LVAD Impella TandemHeart CentriMag Biomedicus

40 Conclusions IABP continue to be the first choice of MCS in pts with CS. More studies are needed in pts with an AMI undergoing primary PCI to establish the best approach. Percutaneous VAD achieve faster and higher hemodynamic stability. However, this did not translate into improved 30-day survival Percutaneous or surgical VAD implant should not be delayed in patients without initial stabilization with IABP or presenting with profound CS

41 Conclusions Despite the rapid hemodynamic stabilization achieved with VAD, the high rate of complications or advanced inflammatory syndrome and ongoing multi-organ failure may explain the high mortality How to apply this expensive technology in the real world and how to define when ongoing efforts are futile is still a challenge (J TallaJ JACC 2010) In very selected patients with cardiogenic shock, LVAD can be successfully bridge to HT

42

43 IABP as an Adjunct to Thrombolytic Therapy J Thromb Thrombolysis 2005; 19:33-9

44 Meta-analysis of randomized clinical trials of IABP therapy in STEMI. All meta-analyses show effect estimates for the individual trials, for each type of reperfusion therapy and for the overall analysis. Sjauw K D et al. Eur Heart J 2009;30:

45 IABP SHOCK Trial in STEMI and CS 40 pts were randomized before coronary angiography and PCI 19 IABP, 21 standard therapy without PCI

46 TandemHeart Randomized trial of 42 patients with cardiogenic shock 70% ACS 30% Decompensated HF 71% with shock despite IABP Centers implanting first patient were allowed to implant the TandemHeart in the Roll In phase (non-randomized). Mean support duration=2.5 days Burkhoff et al. Am Heart J 2006;152:469

47 TandemHeart Results 42 patients with cardiogenic shock randomized to IABP or TandemHeart Am Heart J 2006;152:469

48 TandemHeart No difference in 30 day survival rates (IABP 64% vs. TandemHeart 53%) No difference in frequency of adverse events Am Heart J 2006;152:469

49 Cardiology research and practice 2012 LVADs currently in use

50 ADVANCED MECHANICAL SUPPORT

51 Indications for VAD Therapy Bridge to Recovery/ Explantation Bridge to Bridge Bridge to Transplant Bridge to Decision Destination Therapy Device intended for short term support for a condition that is anticipated to reversible Device intended for short term support (typically inserted in an emergent situation) until a more permanent device can be implanted Device typically intended for short-to intermidiate-term support in patients actively listed for transplantation Device inserted to support a patient in whom the ultimate therapy is not able to be determined at the time of implantation. Device may be used for short or long-term support. Device inserted with the intention of long-term support in patients who are not candidates for transplantation

52 Choices of Device Choices continue to evolve with changing technology Percutaneous Intra-aortic balloon pump Impella Tandem-heart ECMO Surgically implanted Centrimag Abiomed AB5000 Thoratec pvad Long term VADs (e.g., HeartMate II)

53 Heartmate II

54 Heartware

55 Circulite Synergy Surgical or percutaneous implant Partial cardiac assist Flow 2-3 L/min Modeling suggests reduction of LVEDP 7-10 mmhg 8-12 hours of untethered support

56 Outline Which Patients? Which Device? What Next?

57 Clinical Profiles in AHF: Data from Euro Heart Failure Survey II N=3580 Decomp. HF Pulm. Edema HTN HF Cardiogenic shock Nieminen, M et al Eur Heart J 2006

58 Mortality in AHF by Clinical Classification Nieinen MS et al. Eur Heart J 2006

59 SBP in AHF: Higher is Better? Gheorghiade M et al JAMA 2007

60 ADHERE CART: Predictors of Mortality Fonarow et al. JAMA 2005

61 Outline Which Patients? Which Device? What Next?

62 Surgically Implantable Temporary MCSD

63 Where to Next?

64

65 Summary and Conclusions Percutaneous mechanical circulatory support devices are growing in capability and complexity Patient selection remains the most critical component of success with these devices Randomized data is sparse and complicated by the critical acute illness of many of these patients It is likely that centers invested in percutaneous circulatory support will require> 1 device to satisfy the needs of the entire population Conceptually we are moving from total cardiac output replacement to partial hemodynamic support