Support Technologies and High Risk Intervention Patient Selection: When Not to Use Them Ted Feldman, M.D., MSCAI FACC FESC Evanston Hospital SCAI Fall Fellows Course Las Vegas December 7-10 th, 2014
Ted Feldman MD, MSCAI FACC FESC Disclosure Information The following relationships exist: Grant support: Abbott, BSC, Edwards, WL Gore Consultant: Abbott, BSC, Coherex, Edwards, Intervalve, JenaValve, Diiachi Sankyo-Lilly, WL Gore Off label use of products and investigational devices will be discussed in this presentation
IABP
2013 ACC/AHA STEMI Guidelines: Treatment of Cardiogenic Shock I IIa IIb III B The use of intra-aortic balloon pump counterpulsation can be useful for patients with cardiogenic shock after STEMI who do not quickly stabilize with pharmacological therapy. I IIa IIb III Alternative LV assist devices for circulatory support may be considered in patients with refractory cardiogenic shock. Circulation 2013
JACC 29:1459, 1997
Thiele et al. N Engl J Med 2012;367:1287-96
Is the IABP Indicated in All Patients with Cardiogenic Shock? Thiele et al. N Engl J Med 2012;367:1287-96
IABP SHOCK II: 1 Year Mortality 30-day mortality 6-month mortality 12-month mortality 60% 50% 41.3% 48.7% 49.2% 51.8% 51.4% IABP Control Mortality 40% 30% 20% 39.7% Logrank p = 0.94 RR 1.02 95% CI 0.88-1.19 10% No. at risk IABP Control 0% 0 30 60 90 120 150 180 210 240 270 300 330 360 390 420 Days after randomization 301 181 171 165 161 159 154 152 149 147 146 144 136 45 21 299 174 166 165 159 154 154 152 147 147 146 144 140 55 29 Thiele et al. Lancet 2013
Tandem Heart
A randomized evaluation of TandemHeart vs IABP for cardiogenic shock 100 30 Day Mortality Percent 30 Day Mortality 80 60 40 20 0 64 NS 53 IABP TandemHeart Overall 30 day survival was 64% (9/14) with IABP vs 53% (10/19 for TandemHeart (Am Heart J 2006;152:469.e1-469.e8
Impella
Circulation 2012;126:1717-1727
Impella 2.5 vs. IABP in High Risk PCI The PROTECT II Trial Circulation 2012;126:1717-1727
Baseline Patient Characteristics IABP (N=211) Impella (N=216) P Age 67±11 68±11 0.583 Gender-Male 82.0% 80.6% 0.704 History of CHF 82.9% 91.2% 0.011 Current NYHA (Class III / IV) 54.9% 58.5% 0.485 Diabetes Mellitus 49.3% 53.2% 0.414 Renal insufficiency 30% 22.7% 0.086 Peripheral Vascular Disease 27.0% 25.4% 0.697 Implantable Cardiac Defib. 31% 35.6% 0.304 Prior CABG 28.9% 39.4% 0.023 LVEF 24.0±6.3 23.3±6.3 0.258 STS Mortality score 6±7 6±6 0.562 Not Surgical Candidate 64.5% 63.4% 0.825 SYNTAX score 29.5±13.7 30.3±13.2 0.595
Conclusions: The 30-day incidence of major adverse events was not different for patients with IABP or Impella 2.5 hemodynamic support. However, trends for improved outcomes were observed for Impella 2.5 supported patients at 90 Days. Circulation 2012;126:1717-1727
90 Day Impact of Hemodynamic Support With Impella 2.5 vs IABP in High-Risk PCI PROTECT II Randomized Trial Am J Cardiol 2014;113:222-228
90 Day Impact of Hemodynamic Support With Impella 2.5 vs IABP in High-Risk PCI PROTECT II Randomized Trial MACCE=all-cause mortality, MI, stroke or TIA, any rerevascularization PCI or CABG Am J Cardiol 2014;113:222-228
ECMO Extra Corporeal Membrane Oxygenation
ECMO Heart failure Respiratory insufficiency Critically ill patient Inexistance of other forms of treatment which are likely to be successful ECMO Heart failure > Heterogenous condition in which the heart is unable to pump out sufficient blood to meet the metabolic needs of the body 1. Respiratory insufficiency > Inadequate supply of oxygen to the cells of the body, and removal of carbon dioxide 2. Critical ill patients > Individuals whose state of disease may lead to eminent death 3. 1 MeSH Browser [Internet]. MeSH Unique ID: D006333. 2 MeSH Browser [Internet]. MeSH Unique ID: D012131. 3 MeSH Browser [Internet]. MeSH Unique ID: D016638.
Indications for the use of ECMO Cardiac indications Bridge for patients with end-stage heart failure to heart transplant [3]; Coronary artery bypass graft surgery and valve replacement [4]; Post-cardiotomy and primary graft failure after heart transplant [5]. Severe cardiac failure (e.g. myocarditis, decompensated cardiomyopathy, acute coronary syndrome with cardiogenic shock, sepsis, drug related) [1], [4]; Severe trauma with coexisting bleeding shock [6]. More Recommended* Less Recommended* * In published literature [1] Marasco SF. Review of ECMO (extra corporeal membrane oxygenation) support in critically ill adult patients. Heart Lung Circ. 2008; [3] Schmid C. Extracorporeal life support - systems, indications, and limitations. Thorac Cardiovasc Surg. 2009; [4] Sidebotham D. Extracorporeal membrane oxygenation for treating severe cardiac and respiratory disease in adults: Part 1--overview of extracorporeal membrane oxygenation. J Cardiothorac Vasc Anesth. 2009; [5] Fiser SM. When to discontinue extracorporeal membrane oxygenation for postcardiotomy support. Ann Thorac Surg. 2001; [6] Arlt M. Extracorporeal membrane oxygenation in severe trauma patients with bleeding shock. Resuscitation. 2010
Combined Approaches
Case example EF<15%, sole remaining vessel, failed to open with PTCA
High-risk patients may include those undergoing unprotected left main or last-remaining-conduit PCI, severely depressed EF undergoing PCI of a vessel supplying a large territory, and/or cardiogenic shock. Patient risk, hemodynamic support, ease of application/removal, and operator and laboratory expertise are all factors involved in consideration of use of these devices. With devices that require large cannula insertion, the risk of vascular injury and related complications are important considerations regarding necessity and choice of device.
It's no wonder that truth is stranger than fiction. Fiction has to make sense. Mark Twain