CABG for ischemic cardiomyopathy, post myocardial infarction and cardiogenic shock

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CABG for ischemic cardiomyopathy, post myocardial infarction and cardiogenic shock Yoshiya Toyoda, MD, PhD William Maul Measey Professor of Surgery Chief, Cardiovascular Surgery Surgical Director, Mechanical Circulatory Support Surgical Director, Thoracic Transplantation Temple University School of Medicine Philadelphia, PA

Coronary Artery Disease (CAD) Cardiovascular disease (CVD) accounts for 34 % of all U.S. deaths each year, countless resources, and healthcare expenditures that approach $300 billion annually. Coronary artery disease (CAD) is the most common type of heart disease. It is the leading cause of death in the United States in both men and women. CAD resulting in myocardial infarction (MI) claims over one million lives each year in the U.S. and leads to countless more permanent disabilities including heart failure. Approximately five million Americans currently live with heart failure, and an additional 400,000 patients are newly diagnosed each year. CHF is the most common admitting diagnosis for patients over the age of 65 years, and is associated not only with a decreased quality of life, but also significant mortality. CHF carries a mortality rate of at least 40 % within 2 years of diagnosis. For those patients with the most advanced stages of CHF (New York Heart Association class IV), the 1-year mortality rate exceeds 50 %. In addition, the treatment of CHF is associated with very high and continuingly escalating costs. Not only is CHF the most expensive DRG covered by Medicare and Medicaid, remarkably it is estimated that total medical costs (inpatient and outpatient) associated with the treatment of CHF exceed $29 billion per year.

Coronary Artery Disease (CAD) CABG vs. PCI for Left Main or Three Vessel Disease Syntax (The SYNergy between percutaneous coronary intervention with TAXus and cardiac surgery study) 1-year Data. NEJM 2009;360:961-72. Randomly assigned 1800 patients with three-vessel or left main coronary artery disease to undergo CABG or PCI (in a 1:1 ratio). A noninferiority comparison of the two groups was performed for the primary end point a major adverse cardiac or cerebrovascular event (i.e., death from any cause, stroke, myocardial infarction, or repeat revascularization) during the 12-month period after randomization. Results Most of the preoperative characteristics were similar in the two groups. Rates of major adverse cardiac or cerebrovascular events at 12 months were significantly higher in the PCI group (17.8%, vs. 12.4% for CABG; P=0.002), in large part because of an increased rate of repeat revascularization (13.5% vs. 5.9%, PP<0.001) as a result, the criterion for noninferiority was not met. At 12 months, the rates of death and myocardial infarction were similar between the two groups; stroke was significantly more likely to occur with CABG (2.2%, vs. 0.6% with PCI; P=0.003). Conclusions CABG remains the standard of care for patients with three-vessel or left main coronary artery disease, since the use of CABG, as compared with PCI, resulted in lower rates of the combined end point of major adverse cardiac or cerebrovascular events at 1 year.

Syntax 1-year Data. NEJM 2009;360:961-72.

Syntax 1-year Data. NEJM 2009;360:961-72.

Syntax 5-year Data. Lancet, 381 (2013), pp. 629-638. 1800 patients were randomly assigned to CABG (n=897) or PCI (n=903). After 5 years follow-up, Kaplan-Meier estimates of MACCE were 26 9% in the CABG group and 37 3% in the PCI group (p<0 0001). Estimates of myocardial infarction (3 8% in the CABG group vs 9 7% in the PCI group; p<0 0001) and repeat revascularisation (13 7% vs 25 9%; p<0 0001) were significantly increased with PCI versus CABG. All-cause death (11 4% in the CABG group vs 13 9% in the PCI group; p=0 10) and stroke (3 7% vs 2 4%; p=0 09) were not significantly different between groups. 28 6% of patients in the CABG group with low SYNTAX scores had MACCE versus 32 1% of patients in the PCI group (p=0 43) and 31 0% in the CABG group with left main coronary disease had MACCE versus 36 9% in the PCI group (p=0 12); however, in patients with intermediate or high SYNTAX scores, MACCE was significantly increased with PCI (intermediate score, 25 8% of the CABG group vs 36 0% of the PCI group; p=0 008; high score, 26 8% vs 44 0%; p<0 0001). 3-year/5-year SYNTAX trial data in 2012 comparing PCI and CABG provides compelling insights into the statistically significant and overwhelming survival and event-free survival benefit conferred on patients who receive CABG surgery. At 5-year follow-up, clinical results from SYNTAX showed that CABG was superior to DES- PCI with respect to the composite endpoint of death, myocardial infarction, stroke, or repeat revascularization, with the benefit driven predominantly by decreased rates of repeat revascularization and myocardial infarction with no significant differences in rates of death or stroke.

CABG vs. Medical Therapy in Ischemic Cardiomyopathy The Coronary Artery Surgery Study (CASS) trial in 1985, showed that coronary artery bypass graft (CABG) improved survival in comparing 420 medically treated and 231 CABG patients with left ventricular ejection fraction (LVEF) 35% in the nonrandomized Registry cohort. The benefit was most apparent for patients with angina and LVEF 25%; medically treated patients in this cohort had a 43 % 5-year survival while CABG recipients benefited from a 63 % 5-year survival. Operative mortality in the CASS series was 6.9 %.

CABG in Ischemic Cardiomyopathy STITCH trial. NEJM 2016;374:1511-20. CABG in ICMP (LVEF<35%) From July 2002 to May 2007, a total of 1212 patients with an ejection fraction of 35% or less and coronary artery disease amenable to CABG were randomly assigned to undergo CABG plus medical therapy (CABG group, 610 patients) or medical therapy alone (medical-therapy group, 602 patients). The primary outcome was death from any cause. Major secondary outcomes included death from cardiovascular causes and death from any cause or hospitalization for cardiovascular causes. The median duration of follow-up, including the current extended-follow-up study, was 9.8 years. RESULTS A primary outcome event occurred in 359 patients (58.9%) in the CABG group and in 398 patients (66.1%) in the medical-therapy group (hazard ratio with CABG vs. medical therapy, 0.84; 95% confidence interval [CI], 0.73 to 0.97; P=0.02 by log-rank test). A total of 247 patients (40.5%) in the CABG group and 297 patients (49.3%) in the medical-therapy group died from cardiovascular causes (hazard ratio, 0.79; 95% CI, 0.66 to 0.93; P=0.006 by log-rank test). Death from any cause or hospitalization for cardiovascular causes occurred in 467 patients (76.6%) in the CABG group and in 524 patients (87.0%) in the medical-therapy group (hazard ratio, 0.72; 95% CI, 0.64 to 0.82; P<0.001 by log-rank test). CONCLUSIONS In a cohort of patients with ischemic cardiomyopathy, the rates of death from any cause, death from cardiovascular causes, and death from any cause or hospitalization for cardiovascular causes were significantly lower over 10 years among patients who underwent CABG in addition to receiving medical therapy than among those who received medical therapy alone.

CABG in Ischemic Cardiomyopathy STITCH trial. NEJM 2016;374:1511-20. CABG in ICMP (LVEF<35%)

STITCH trial. NEJM 2016;374:1511-20. CABG in ICMP

Myocardial viability by MRI and survival. JACC 2012;59:825-835. Many believe that the selection of patients with ischemic cardiomyopathy for CABG should be based on the presence of viable myocardium. DE-CMR may be useful to predict, not only functional improvement of patients with CAD and LV dysfunction, but also survival. Indeed, the study showed that revascularization of dysfunctional viable myocardium provides a significant improvement in patient outcomes versus medical treatment. It thus suggests that patients with viable myocardium should be revascularized to improve survival.

Patients with viable myocardium and low LVEF (24+/- 7%): Complete Revascularization is better than incomplete revascularization or medical therapy.

Case. Cardiogenic Shock Complicating MI W.S., 55-year-old Male, 69 in, 222 lbs, BMI 32 Active Smoker (43 pack years) DM, HLD, PVD (SFA stent), COPD, OSA Shortness of Breath for 2 weeks NSTEMI (TnI 4.4), NYHA Class IV WBC 9.1, Hct 45, Plt 285 ABG: 7.46/21/81 BUN: 13, Cr 0.82, T-Bil 1.1, Alb 3.2, INR 1.0

Case. Cardiogenic Shock Complicating MI W.S., 55M, NSTEMI, Shortness of Breath for 2 weeks LVEF: 10-15% LVID ed: 68mm LVID es: 63mm MV: mild MR RV: TV: Dilated Decreased function no TR

Case. Cardiogenic Shock Complicating MI W.S., 55M, LM+3VD, NSTEMI, NYHA Class IV HR: 114 AoP: 92/75 (83) LVP: 98/36 RAP: 17/12(14) RVP: 50/18 PAP: 51/34(41) PCWP: 39/37(34) SaO2: 94 SvO2: 57 CO (Fick): 4.05 CI (Fick): 1.85 LVSWI: 10.74 RVSWI: 6.08 PVR: 1.73

Case. Cardiac Arrest Complicating MI W.S., 55-year-old Male Ischemic Cardiomyopathy (LVEF 10-15%) LM+3VD, Non STEMI, NYHA IV VFib Cardioversion x 2 IABP Insertion VFib Cardioversion x 8 Intubation, CPR Next Step??

Case. Cardiogenic Shock Complicating MI W.S., 55-year-old Male Ischemic Cardiomyopathy (LVEF 10-15%) LM+3VD, Non STEMI, NYHA IV, Cardiac Arrest Emergency Off-Pump CABG x 6 LIMA-LAD SVG-Diag1-Diag2 SVG-RI-OM-PDA

Case. Cardiac Arrest Complicating MI W.S., 55-year-old Male Ischemic Cardiomyopathy (LVEF 10-15%) LM+3VD, Non STEMI, NYHA IV, Cardiac Arrest S/P OPCAB x 6 POD#0: Hemodynamically Stable POD#1: VFib Cardioversion x 3 Centrimag LVAD, Off Pump 31Fr. venous cannula in left atrium 20Fr. arterial cannula in aorta

Short-Term Mechanical Circulatory Support CentriMag Rotaflow Impella Biomedicus TandemHeart

Long-Term Mechanical Circulatory Support HeartMate II HeartMate 3 HeartWare HVAD Syncardia TAH

Case. 55 M, acute on chronic heart failure, ischemic cardiomyopathy, NSTEMI VFib x 2 IABP Insertion VFib x 8, Intubation, CPR Emergency CABG with VAD back up OPCAB x 6 POD#0 Hemodynamically stable POD#1 Vfib x 3 Centrimag LVAD POD#2: VFib x 2 POD#3: VFib x 26

Case. Cardiac Arrest Complicating MI W.S., 55-year-old Male Ischemic Cardiomyopathy (LVEF 10-15%) LM+3VD, Non STEMI, NYHA IV, Cardiac Arrest S/P OPCAB x 6 POD#1: VFib Cardioversion x 3 Centrimag LVAD POD#2-3: VFib Cardioversion x 28 All grafts patent Centrimag RVAD, Off Pump 40Fr. venous in right atrium 20Fr. arterial in pulmonary artery

Bi-Ventricular Assist Device with Central Cannulation

Securing the cannula for ambulation

Ambulation on CentriMag BiVAD POD#1: Centrimag LVAD: 6.5 L/min POD#3: Centrimag RVAD: 5.5 L/min POD#4~11: Vfib Cardioversion x 29

W.S., 55M, Ischemic Cardiomyopathy Preop.: VFib Cardioversion x 10 OPCAB x 6 POD#1: VFib Cardioversion x 3 Centrimag LVAD POD#2-3:VFib Cardioversion x 28 Centrimag RVAD POD#4-11: VFib Cardioversion x 29 POD#12 POD#28 Centrimag LVAD: 6.5L/min 2.4L/min Centrimag RVAD: 5.5L/min 1.5L/min

W.S., 55M, s/p OPCAB x 6, Centrimag BiVAD POD#38: BiVAD Explantation HR 93 BP 95/57(71) RAP 13 PAP 38/21(25) PCWP 16 CO/CI 9.5/4.3 SvO2 87 POD#58: Discharged Home

CentriMag BiVAD, Bridge-to-Recovery for Ischemic Cardiomyopathy, Cardiogenic Shock/Cardiac Arrest, s/p OPCAB x 6, Doing well 5 years postop

Acute on chronic heart failure, ischemic cardiomyopathy, NSTEMI Cardiogenic Shock, Vfib, IABP Complete Revascularization, OPCAB x 6 Postcardiotomy Vfib VAD as Bridge-to-Recovery Recovery, Centrimag Explant

Case. 72 M, acute on chronic heart failure, ischemic cardiomyopathy, NSTEMI Diffuse CAD (3VD), cardiogenic shock placed on Impella LVAD LVEF 10-15%, LVDd 66mm LVDs 58mm despite on Impella CP

Case. 72 M, ischemic cardiomyopathy, cardiogenic shock on Impella s/p Off Pump CABG x 6 (LIMA-Diag-LAD, SVG-RI-OM, SVG-PDA-PLA) Explant of Impella. Discharged home on POD#16. SVG-RI-OM All grafts patent LIMA-Diag-LAD SVG-PDA-PLA

Case. 61F, Cardiogenic shock following STEMI, Severe PAD, Smoker Diffuse CAD (Left main + 3VD), STEMI, cardiogenic shock placed on IABP LVEF 15-20%, Emergency OPCAB x 3 (LIMA-LAD, SVG-RCA-OM)

Case. 61F, Cardiogenic shock following STEMI S/P Emergency CABG x 3 (LIMA-LAD, SVG-RCA-OM) Persistent low cardiac output, Ventricular tachcardia/fibrillation POD# 6: All grafts patent

Case. 61F, Cardiogenic shock following STEMI S/P Emergency CABG x 3 (LIMA-LAD, SVG-RCA-OM) POD# 6: HeartMate II LVAD Implantation POD# 43: Discharge home

Case. 61F, Cardiogenic shock following STEMI S/P Emergency CABG x 3 (LIMA-LAD, SVG-RCA-OM) POD#6 from OPCAB: s/p HeartMate II LVAD POD#85 from HeartMate II LVAD: HeartMate II LVAD Explant 5 Years postop. NYHA Class I, LVEF 45%, improved from 15-20%

At least one in three heart surgeons has refused to treat critically ill patients because they are worried it will affect their mortality ratings if things go wrong. 84 percent said they were aware of other surgeons doing the same. Clinical decision-making had been adversely affected by the culture of transparency.

Off Pump Double Lung Tx OPCAB x 1 (LIMA-LAD) Through Median Sternotomy

Single Left Lung Tx + OPCAB x 2 (SVG-Ramus-LAD) for IPF + CAD + Radiation Chest

Recipient: 63M, 71in, 207lbs, IPF, CAD Donor: 44M, 71in, 181lbs Single Left Lung Tx, Off-Pump OPCAB x 1 (LIMA-LAD) Ischemic Time: 172 minutes Hospital Stay: 11 days

Lung Transplantation at Temple N=240, 2012.3-2016.8 Concomitant CABG + Lung Transplant (N=17, 7%) CABG: bypass grafts 1-3 Survival rate: 100% during the first year

Isolated CABG (YT: n=466) at Temple from 11-2011 to 1-2017 Complete Revascularization 200 180 160 140 120 100 80 60 40 20 0 118 182 96 CABG x 4 8 (n=310, 67%) 32 27 6 3 2 x 1 x 2 x 3 x 4 x 5 x 6 x 7 x 8

Isolated CABG (YT: n=466) at Temple from 11-2011 to 1-2017 Off Pump vs. On Pump 50, 11% 416, 89% Off Pump On Pump

Isolated CABG (n=382) at Temple from 11-2011 to 12-2014 Demographics CABG (Off- Pump) (n=180) CABG (On- Pump) (n=202) P-value Age 63 ± 9 62 ± 10 0.201 Gender (male) 66% 70% 0.652 Height (inches) 66 ± 7 67 ± 4 0.138 Weight (lbs) 192 ± 45 188 ± 44 0.444 BMI (kg/m 2 ) 31 ± 7 30 ± 6 0.145 Smokers 65% 23% 0.0001 Hypertension 80% 86% 0.111 Diabetes 54% 51% 0.331

Isolated CABG (n=382) at Temple from 11-2011 to 12-2014 CABG (Off- Pump) (n=180) CABG (On- Pump) (n=202) P-value Race 34%- AA 27%- W 49%- O 24%- AA 27%- W 40%- O 0.110 Previous MI 21% 33% 0.011 Previous CVA 13% 12% 0.720 Pre-EF (%) 44 ± 18 (5-70%) 48 ± 16 (10-70%) 0.982

Isolated CABG (n=382) at Temple from 11-2011 to 12-2014 CABG (Off- Pump) (n=180) CABG (On- Pump) (n=202) P-value Emergency/ Urgent Grafts (average) Bypass grafts# (ranges) Observed/Expect ed Mortality Index Cerebrovascular Events (stroke) 56% 35% 0.001 3.3 ± 1.2 2.7 ± 1.0 0.0001 1 to 8 1 to 5 0.0000 0.73 1.67 0.05 0 10 0.0000

CABG for ischemic cardiomyopathy, post myocardial infarction and cardiogenic shock Off Pump vs. On Pump Avoid global ischemia to already damaged myocardium Use shunt to minimize regional ischemia On pump, beating heart without global ischemia: when hemodynamically unstable, severe cardiomegaly Proximal anastomosis first to measure the exact length of free grafts Proximal anastomoses with HeartString to avoid side biting clamp for hostile aorta Sequential anastomoses with respect to the target anatomy More targets possible

CABG for ischemic cardiomyopathy, post myocardial infarction and cardiogenic shock Cardiogenic Shock Mechanical circulatory support to achieve optimum hemodynamics: Bridge-to-Decision Peripheral: IABP, Impella (LVAD, RVAD), TandemHeart (LVAD, RVAD), Veno- Arterial ECMO Central: Veno-Arterial ECMO, LVAD, RVAD, BiVAD Bridge-to-PCI, Support for high risk PCI Bridge-to-CABG Bridge-to-Long Term VAD: no viability, poor targets, poor run off, good social support

CABG for ischemic cardiomyopathy, post myocardial infarction and cardiogenic shock Complete revascularization Use of mechanical circulatory support Off Pump vs. On Pump