Percutaneous Mechanical Circulatory Support Devices From Guidelines to Practice Moderator Deepak L. Bhatt, MD, MPH Professor of Medicine Harvard Medical School Executive Director of Interventional Cardiovascular Programs Brigham and Women's Hospital Heart and Vascular Center Boston, Massachusetts Title Slide Layout

Panelists Atman P. Shah, MD Simon R. Redwood, MBBS, MD Associate Professor of Medicine Clinical Director, Coronary Care Unit Co-Director, Adult Cardiac Catheterization Laboratory University of Chicago Medicine Chicago, Illinois Panelists Layout (Title slide layout) Simon R. Redwood, MBBS, MD Professor of Interventional Cardiology St Thomas Hospital King’s College London London, United Kingdom

Case Presentation 57-year-old man presents with an anterior STEMI PCI to LAD undertaken -- unable to reopen vessel despite prolonged attempt Persisting ST elevation at the end of case BP 110/60 mm Hg Transferred to CCU at 6 pm Clinical deterioration by the following morning Oliguric Diaphoretic Cool peripheries Lactate 4 Persisting ST elevation BP 120/80 mm Hg ECHO -- poor EF -- 10% Transferred to cath lab for hemodynamic support in view of (incipient) cardiogenic shock

Presenting ECG Courtesy of Simon R. Redwood, MBBS, MD.

Postprocedure ECG Courtesy of Simon R. Redwood, MBBS, MD.

Stabilization After IABP Implantation IABP 1:1; 2 min following deployment IABP 1:1; 15 min following deployment Courtesy of Simon R. Redwood, MBBS, MD.

Pulmonary Artery Pressure PAP; Pre-IABP - Mean 34 PAP; 2-min Post-IABP - Mean 27 Courtesy of Simon R. Redwood, MBBS, MD.

OUTCOME Pain and ST elevation settled over next 2 hours Lactate normalized IABP weaned 72 hours later Underwent successful CABG day 6 Uncomplicated recovery, post-CABG EF 25%

Case Key Points IABPs are most useful in patients who have persistent ischemia Routine use of IABPs does not provide an overall benefit Careful selection of eligible patients who have persistent ischemia can yield dramatic and life- saving results

Hemodynamic Effects of IABP Increases diastolic blood pressure Decreases afterload Decreases myocardial oxygen consumption Increases coronary artery perfusion Modestly enhances cardiac output Modest ventricular unloading Increases mean arterial pressure and coronary blood flow Rihal CS, et al. J Am Coll Cardiol. 2015;65:e7-e26.

Options for Mechanical Cardiopulmonary Support IABP Impella® TandemHeart™ ECMO (Extracorporeal membrane oxygenation)

2013 ACCF/AHA Guideline for the Management of STEMI IIA Recommendation (Level of Evidence: B) “The use of IABP can be useful for patients with cardiogenic shock after STEMI who do not quickly stabilize with pharmacological therapy” O’Gara PT, et al. Circulation 2013;127:e362-e425.

Cost-Effectiveness Significant upfront cost of all the devices that many hospitals discourage Which device provides the best clinical utility? Prospect for a prolonged clinical benefit? What is an acceptable cost?

Possible Indications for Mechanical Circulatory Support Devices Complications of AMI Severe heart failure in the setting of nonischemic cardiomyopathy Acute cardiac allograft failure Posttransplant RV failure Patients slow to wean from cardiopulmonary bypass following heart surgery Refractory arrhythmias Prophylactic use for high-risk PCI High-risk or complex ablation of ventricular tachycardia High-risk percutaneous valve interventions Rihal CS, et al. J Am Coll Cardiol. 2015;65:e7-e26.

Balancing the Issue of Cost Selecting the Right Device for the Right Patient Many factors to consider, including recent drop in blood pressure? cardiac arrest patient? cardiogenic shock? high-risk PCI? age of the patient risk factors EF myocarditis? structural heart complication? do they need oxygenation?

Hemodynamic Support for the Cardiac Arrest Survivor Start with IABP Lower cost Good effectiveness Quickest and most familiar way to obtain some degree of hemodynamic stabilization, especially in the setting of AMI with pump failure Step up to more supportive devices if patients do not stabilize Rihal CS, et al. J Am Coll Cardiol. 2015;65:e7-e26.

Impella® Minimizes or eliminates pressor use Reduces myocardial oxygen demand Improves systemic perfusion, thereby avoiding systemic shock Rihal CS, et al. J Am Coll Cardiol. 2015;65:e7-e26.

Vasopressors vs Support Devices Consider any ongoing ischemia and the potential effect of increasing myocardial oxygen If the patient is not doing well on 1 IV vasopressor consider increasing the level of support to MCS Use of multiple pressors potentially increase the risk of arrhythmias

ECMO Provides cardiopulmonary support for patients whose heart and lungs can no longer provide adequate physiologic support veno-veno for oxygenation only veno-arterial for oxygenation and circulatory support In the setting of interventional cardiology and PCI not used as a first-line agent Using ECMO with another device such as Impella or IABP may help in reducing afterload Rihal CS, et al. J Am Coll Cardiol. 2015;65:e7-e26.

TandemHeart™ Pumps blood extracorporeally from the left atrium (LA) to the iliofemoral arterial system pump contribute flow to the aorta simultaneously (thereby working in parallel, or tandem) The redirection of blood from the LA reduces LV preload, LV workload, filling pressures, wall stress, and myocardial oxygen demand The increase in arterial blood pressure and cardiac output supports systemic perfusion Expertise with transseptal puncture is required Rihal CS, et al. J Am Coll Cardiol. 2015;65:e7-e26.

MCS for High-Risk PCI Patient With Left Main, Last Remaining Conduit, or Severe Multivessel Disease Normal or mildly reduced left ventricular function Severe left ventricular dysfunction (EF < 35%) or recent decompensated heart failure Anticipated Noncomplex PCI None IABP/Impella® as backup Anticipated Technically Challenging or Prolonged PCI IABP/Impella as backup Impella® or TandemHeart™, choice dependent upon vascular anatomy, local expertise, and availability. ECMO for concomitant hypoxemia or RV failure. A suggested schema for use of support devices for high-risk PCI based upon clinical and anatomic circumstances. The greater the likelihood of hemodynamic compromise or collapse the greater the potential benefit of MCS. Rihal CS, et al. J Am Coll Cardiol. 2015;65:e7-e26.

Summary Routine use of hemodynamic support device is probably not necessary Individualize care to each patient Making early decision between device vs pressor and which device is important MCS devices have different characteristics The IABP is very good at improving coronary flow in the presence of persistent ischemia and has afterload reduction properties Impella® provides more support than the IABP at 3.5-5 L/min. It is used when patients are at more extreme risk or at the extreme end of the hemodynamics spectrum. Actively unloads the LV.

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