Intraaortic Balloon Counterpulsation- Supportive Data for a Role in Cardiogenic Shock ( Be Still My Friend )

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Intraaortic Balloon Counterpulsation- Supportive Data for a Role in Cardiogenic Shock ( Be Still My Friend ) Stephen G. Ellis, MD Section Head, Interventional Cardiology Professor of Medicine Cleveland Clinic 8 min talks; COI SGE; 118-1, 1

Cardiogenic Shock After Acute MI Typical characteristics Age > 65 Anterior MI Systolic BP <100 mmhg Heart Rate >100 bpm Accounts for 90% of risk (GUSTO 1) Additional Facts 75% of patients develop CS within 24 hours, but present on admission in only 15% Average EF is only moderately reduced (~ 30%) SVR is not severely elevated in many patients (1350-1400 dynes-sec-cm-5) Cardiac power (CI x MAP) is the most powerful hemodynamic predictor of mortality Hasdai et al. JACC 2000;35:136 43; SHOCK Trial SGE; 0213-3, 2

Cardiogenic Shock Etiology Shock Trial and Registry Hochman et al. JACC 2000; 36: 1063 SGE; 0213-3, 3

Pathophysiology of Cardiogenic Shock When a critical mass of LV is necrotic and fails to pump, stroke volume and CO fall Myocardial and coronary perfusion are compromised causing tachycardia and hypotension Increased LVEDP further decreases coronary perfusion Increase LV wall stress increases myocardial oxygen demand Lactic acidosis worsens myocardial performance SGE; 0213-6, 6

Shock Trial Acute Myocardial Infarction 36 hrs Cardiogenic Shock 12 hrs Randomization Emergency Revascularization IABP/Pharmacologic Support Possible Prior Thrombolysis Emergency Early PTCA/CABG 6 hrs Hochman, AHJ 137: 313, 1 Initial Medical Stabilization IABP/Pharmacologic Support Thrombolysis Unless Absolute Contraindication Possible Delayed Revascularization > 54 hrs SGE; 0213-3, 4

Shock Trial Treatment Received Revascularization Medical therapy Treatment n=152 n=150 CPR, VT, or VF before randomization (%) 32.7 23.9 Thrombolytic therapy (%) 49.3 63.3 Inotropes or vasopressors (%) 99.3 98.6 Intraaortic balloon counterpulsation (%) 86.2 86.0 Pulmonary-artery catheterization (%) 93.4 96.0 Left ventricular-assist device (%) 3.6 0.9 Heart transplantation (%) 2.0 0.7 Coronary angiography (%) 96.7 66.7 Angioplasty (%) 54.6 14.0 Stent placed 35.7 52.3 Platelet glycoprotein IIb/IIIa receptor antagonist 41.7 25.0 Coronary-artery bypass grafting (%) 37.5 11.3 Angioplasty or coronary-artery bypass grafting (%) 86.8 25.3 Median time from randomization to 1.4 102.8 revascularization ( hr) (0.6-2.8) (79.0-162.0) Hochman et al: NEJM 341:625, 1999 SGE; 0213-3, 5

Shock Trial Long Term Outcomes P=0.03 Early revascularization Initial medical stabilization Early revascularization, compared to initial medical stabilization, resulted in 13.2% absolute improvement in 6-year survival 8 patients needed to be treated to save 1 life Hochman et al: JAMA 295:2511, 2006 SGE; 0213-3, 7

Physiological Effects of IABP Cardiac Index (L/min/M 2 ) 40% Cardiac Output 500 ml/min Arterial Lactate (mmol/l) 42% Heart Rate Systolic BP 7 bts/min 20 mmhg Coronary Blood Flow (M 2 /100g/min) 34% Diastolic BP 30 mmhg SGE; 0213-6, 12

Reperfusion and IABP in AMI Canine LAD occlusion model Grp 1= 6 hr occlusion Grp 2= 2 hr occlusion, then reperfusion Grp 3= 2 hr occlusion, then IABP + reperfusion Nanas et al., Ann Thorac Surg 1996;61:629-34 SGE; 0213-8, 2

(%) Infarction of the LV in the IABP-Pre and IABP-Post Yorkshire pig LAD 1 hr occl P<.05 IABP just before or 15 min After reperfusion P<.05 LeDoux JF et al., Catheterization and Cardiovascular Interventions 72:513 521 (2008) SGE; 0213-8, 3

Most Commonly Used Mechanical Devices in the CathLab SGE; 0213-4, 3

Comparison of Support Devices IABP TandemHeart Impella Catheter Size 7.5-9.0 21/17/15 9 Cannula Size 8.5-10 21/17/15 12 # Insertion Sites 1 2 1 Anticoagulation + ++/+++ + Transeptal No Yes No Limb ischemia + +++ + Priming volume No Yes No Unloads Directly LV No No Yes Requires stable rhythm Yes No No Improve hemodynamics + +++ ++/+++ SGE; 0213-4, 5

IABP: Benefit Summary Reduces infarct size Improves hemodynamics Relatively small diameter vascular access site

Thiele et al., Eur Heart J 2010;31:1828-1835 SGE; 0213-5, 9 Randomized Studies in Cardiogenic Shock

Randomized Studies in Cardiogenic Shock NEJM 367:1287, 2012 SGE; 0213-5, 10

ISAR Shock II Simplified Acute Physiology Score-II 80 p = 0.89 p = 0.34 p = 0.02 p = 0.005 p = 0.14 60 40 20 0 IABP Control Baseline Day 1 Day 2 Day 3 Day 4 Thiele H, Zeymer U, Neumann F-J, et al. N Engl J Med 2012;367:1287-96 SGE; 0413-5, 45

Primary Study Endpoint (30 Day Mortality) G. Schuler and H. Thiele, et al. SGE; 0213-5, 6

113 min sx -> 1 st contact 196 min sx -> 1 st device SGE; 0213-8, 1

IABP: Benefit Summary Reduces infarct size (in animals, used early) Improves hemodynamics (not that much) Relatively small diameter vascular access site No survival benefit demonstrated

ISAR Shock 26 Patients R IABP 2.5 L Impella Primary Endpoint CI baseline 30 min post-implant Seyfarth J Am Coll Cardiol 2008;52:1584-8 SGE; 0313-1, 3

TandemHeart Shock Study Thiele and al. Eur. Heart Journal 2005 Jul;26(13):1276-83 SGE; 0213-4, 4

IABP vs LVAD Meta-Analysis Cheng et al: EHJ 30:2102, 2009 SGE; 0213-3, 9

IABP vs LVAD Meta-Analysis Cheng et al: EHJ 30:2102, 2009 SGE; 0213-3, 10

IABP for Cardiogenic Shock Rapid revascularization is primary goal IABP allows hemodynamic stabilization to facilitate revascularization IABP generally initiated too late to impact infarct size Patients with profound shock may require more aggressive support to allow revascularization (with larger devices, more expense and risk of vascular complications)