Recommendations for the Use of Mechanical Circulatory Support: Device Strategies and Patient Selection. A Scientific Statement From the American Heart Association

Perspective:

This statement provides recommendations for the use of mechanical circulatory support (MCS) in advanced heart failure (HF), describes the types of MCS available, and provides information on patient selection for MCS.

1. MCS for advanced HF includes percutaneous support devices (e.g., TandemHeart, intra-aortic balloon bump, Impella), extracorporal devices (e.g., ECMO, Abiomed AB 5000, Centrimag), and intracorporeal devices (e.g., HeartMate II, HeartWare, total artificial heart). MCS can be used as a bridge to myocardial recovery, a bridge to transplant (BTT), destination (permanent) therapy (DT), or a bridge to decision in those patients not clearly meeting transplant candidacy.

2. HeartMate II MCS is currently the only continuous flow device approved for destination therapy. Both the HeartMate II and HeartWare devices are Food and Drug Administration (FDA) approved for the BTT indication.

3. MCS can be considered in transplant-eligible patients with advanced HF at high risk for mortality as manifested by HF symptoms at rest or with minimal exertion, failure of conventional HF medical therapy with repeated hospitalization, and/or inotrope requirements and/or organ dysfunction.

4. Intracorporeal MCS can be considered for DT in advanced HF patients who are transplant-ineligible with a high estimated 1-year HF mortality without other life-limiting illnesses or organ impairment.

5. To ensure good outcomes, MCS should be implemented before the onset of significant multisystem dysfunction. Rapid referral to an experienced MCS and/or transplant center is advised, including outpatients who are high risk for decompensation.

6. Preoperative risk factors for poor outcome after left ventricular assist device (LVAD) implant include advanced age, preoperative hepatic and/or renal dysfunction, coagulopathy, malnutrition, respiratory failure, and/or right ventricular failure. Various risk scores exist to estimate patient risk, each with their own benefits and weaknesses.

7. Temporary (extracorporeal or percutaneous) MCS is reasonable in hemodynamically compromised patients with end-organ dysfunction that can be expected to improve with improved cardiac ouput.

8. Complications following LVAD implant include acute or chronic right ventricular failure, aortic insufficiency, shunting from unrecognized patent foramen ovales or septal defects, renal failure, hepatic failure, infection, and stroke.

9. Patient self-care after LVAD implant requires attention to detail, adherence to complicated medical regimens, driveline care, and insurance of a safe power supply to the device. Social, financial, and psychological contraindications to transplant are often viewed as potential contraindications to MCS.

10. Caregiver support is also crucial for patient success on MCS. The burden on caregivers and the caregiver’s ability to provide needed support must be considered prior to implant.

Keywords: Liver Failure, Stroke, Ventricular Dysfunction, Heart-Assist Devices, Respiratory Insufficiency, Risk Factors, Extracorporeal Membrane Oxygenation, Hemodynamics, Heart Septal Defects, Heart Transplantation, Rest, Prostheses and Implants, Heart Diseases, Renal Insufficiency, United States Food and Drug Administration, Cardiology, Heart Failure, Energy Metabolism, United States


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