- Percutaneous MCS provides superior hemodynamic support compared to pharmacologic therapy. This is particularly apparent for the Impella and TandemHeart devices. These devices should remain available clinically and be appropriately reimbursed.
- Patients in cardiogenic shock represent an extremely high risk group in whom mortality has remained high despite revascularization and pharmacologic therapies. Early placement of an appropriate MCS may be considered in those who fail to stabilize or show signs of improvement quickly after initial interventions.
- MCS may be considered for patients undergoing high-risk PCI, such as those requiring multivessel, left main, or last patent conduit interventions, particularly if the patient is inoperable or has severely decreased ejection fraction or elevated cardiac filling pressures.
- In the setting of profound cardiogenic shock, IABP is less likely to provide benefit than continuous flow pumps including the Impella CP and TandemHeart. ECMO may also provide benefit, particularly for patients with impaired respiratory gas exchange.
- Patients with acute decompensated heart failure may benefit from early use of percutaneous MCS when they continue to deteriorate despite initial interventions. MCS may be considered if patients are candidates for surgically implanted VADs or if rapid recovery is expected (e.g., fulminant myocarditis or stress-induced cardiomyopathy).
- When oxygenation remains impaired, adding an oxygenator to a TandemHeart circuit or use of ECMO should be considered based upon local availability.
- There are insufficient data to support or refute the notion that routine use of MCSs as an adjunct to primary revascularization in the setting of large acute myocardial infarction is useful in reducing reperfusion injury or infarct size. Exploratory studies are underway.
- MCSs may be used for failure to wean off cardiopulmonary bypass, considered as an adjunct to high-risk electrophysiologic procedures when prolonged hypotension is anticipated, or rarely, for valvular interventions.
- Severe biventricular failure may require use of both right- and left-sided percutaneous MCS or veno-arterial ECMO. Certain patients may respond to LVAD implantation with inotropes and/or pulmonary vasodilators to support the right heart. MCS may also be considered for isolated acute RVF complicated by cardiogenic shock.
- Registries and randomized controlled trials comparing different strategies in different clinical scenarios are critically needed.
- Early analyses suggest cost-effectiveness of MCS for emergent use in comparison to surgical ECMO or VAD support, and for elective use in comparison to IABP. Further data are necessary.
Table 1. Summary of Device Effects
Device and Effect
- Reduces both peak LV systolic and diastolic pressures and increases LV stroke volume. The net effect is a reduced slope of arterial elastance.
- Significantly reduce LV pressures, LV volumes, and LV stroke volume. The net effect is a significant reduction in cardiac workload.
- Impella CP
(left ventricle to aorta)
- Unloads the LV and increases forward flow, reducing myocardial oxygen consumption, improving mean arterial pressure, and reducing pulmonary capillary wedge pressure.
(left atrium to aorta)
- Reduces LV preload, LV workload, filling pressures, wall stress, and myocardial oxygen demand.
- Increases LV systolic and diastolic pressure, while reducing LV stroke volume. The net effect is an increase in arterial elastance.
Table 2. Suggested Indications for Percutaneous MCS
Indication and Comments
- Complications of AMI
- Ischemic mitral regurgitation is particularly well-suited to these devices as the hemodynamic disturbance is usually acute and substantial. Acutely depressed LV function from a large AMI during and after primary PCI is an increasing indication for temporary MCS use. Cardiogenic shock from RV infarction can be treated with percutaneous right ventricular support.
- Severe heart failure in the setting of nonischemic cardiomyopathy
- Examples include severe exacerbations of chronic systolic heart failure as well as acutely reversible cardiomyopathies such as fulminant myocarditis, stress cardiomyopathy, or peripartum cardiomyopathy. In patients presenting in INTERMACSa profiles 1 or 2, MCS can be used as a bridge to destination VAD placement or as a bridge to recovery if the ejection fraction rapidly improves.
- Acute cardiac allograft failure
- Primary allograft failure (adult or pediatric) may be due to acute cellular or antibody-mediated rejection, prolonged ischemic time, or inadequate organ preservation.
- Post-transplant RV failure
- Acute RV failure has several potential causes, including recipient pulmonary hypertension, intraoperative injury/ischemia, and excess volume/blood product resuscitation. MCS support provides time for the donor right ventricle to recover function, often with the assistance of inotropic and pulmonary vasodilator therapy.
- Patients slow to wean from cardiopulmonary bypass following heart surgery
- Although selected patients may be transitioned to a percutaneous system for additional weaning, this is rarely done.
- Refractory arrhythmias
- Patients can be treated with a percutaneous system that is somewhat independent of the cardiac rhythm. For recurrent, refractory, ventricular arrhythmias, ECMO may be required for biventricular failure.
- Prophylactic use for high risk PCI
- Particularly in patients with severe LV dysfunction (EF <20–30%) and complex coronary artery disease involving a large territory (sole-remaining vessel, left main or three vessel disease). Impella FDA approved for this indication.
- High-risk or complex ablation of ventricular tachycardia
- Similar to HR-PCI, complex VT ablation can be made feasible with percutaneous support. MCS use allows the patient to remain in VT longer during arrhythmia mapping without as much concern about systemic hypoperfusion.
- High-risk percutaneous valve interventions
- These evolving procedures may be aided with the use of MCSs.
Table 3. Suggested Schema for Support Device in High-Risk PCIa
|Patient with left main, last remaining conduit, or severe multivessel disease||Anticipated noncomplex PCI||Anticipated technically challenging or prolonged PCI|
|Normal or mildly reduced left ventricular function||None||Either IABP or Impella|
as back up
|Severe left ventricular dysfunction (EF <35%) or recent decompensated heart failure||Either IABP or Impella|
as back up
|Impella or TandemHeart, choice dependent upon vascular anatomy, local expertise, and availability. ECMO for concomitant hypoxemia or RV failure. Impella FDA approved for this indication.|
a 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.
AMI, acute myocardial infarction; ECMO, extra-corporeal membrane oxygenation; EF, ejection fraction; HR, high risk; IABP, intra-aortic balloon pump; LV, left ventricle; LVAD, left ventricle assist device; MCS, mechanical circulatory support; PCI, percutaneous coronary intervention; pLVAD, percutaneous LV assist device; RV, right ventricle
This Guideline attempts to define principles of practice that should produce high-quality patient care. It is applicable to interventional cardiologists, primary care, and providers at all levels. This Guideline should not be considered exclusive of other methods of care reasonably directed at obtaining the same results. The ultimate judgment concerning the propriety of any course of conduct must be made by the clinician after consideration of each individual patient situation. Neither IGC, the medical associations, nor the authors endorse any product or service associated with the distributor of this clinical reference tool.