- Each year in the United States ~50,000 patients die of advanced heart failure (HF).
- Advanced HF patients are those with clinically significant circulatory compromise who require special care, including consideration for heart transplantation, continuous intravenous inotropic therapy, mechanical circulatory support (MCS), or hospice.
- Typically, such patients have symptoms at rest or with minimal exertion and cannot perform many activities of daily living.
- Commonly used objective measures of functional limitations include:
- Peak oxygen consumption (Vȯ2) ≤14 mL/kg/min (or <50% of expected)
- A 6-minute walk <300 meters
- Many have cardiac cachexia, are failing or intolerant of conventional HF therapy, and require repeated hospitalization for more intensive management.
- Advanced HF patients usually have a life expectancy of <2 years without heart transplantation or MCS.
- As the demand for long-term replacement of diseased hearts increases, there is a clear need for innovative, safe, and durable MCS to treat the growing population of patients with advanced HF.
- The recent development of smaller, more durable, and safer ventricular assist devices (VADs) has enabled MCS to emerge as a practical and effective form of therapy, either until heart transplantation can be performed (as bridge to transplantation [BTT]) or increasingly as an alternative to transplantation as destination therapy (DT).
- There are limited options for patients with advanced HF who are ineligible for heart transplantation, and these individuals face poor prognosis and limited quality of life. When contraindications present a barrier for heart transplantation, alternative surgical options should be considered, especially for the younger patient. Patients selected for DT may have significant improvement of heart transplantation contraindications and ultimately be selected for transplantation.
Table 1. Current Recommendations for MCS
|ACCF/AHA 2009 HF guidelines|
|Consideration of a left ventricular assist device (LVAD) as permanent therapy or DT is reasonable in highly selected patients with refractory end-stage HF and an estimated 1-year mortality >50% with medical therapy. (II-B)|
|HFSA comprehensive HF practice guidelines|
|Patients awaiting heart transplantation who have become refractory to all means of medical circulatory support should be considered for an MCS device as a BTT. (B)|
|Permanent mechanical assistance with an implantable LVAD may be considered in highly selected patients with severe HF refractory to conventional therapy who are not candidates for heart transplantation, particularly those who cannot be weaned from intravenous inotropic support at an experienced HF center. (B)|
|Patients with refractory HF and hemodynamic instability and/or compromised end-organ function with relative contraindications to cardiac transplantation or permanent MCS expected to improve with time or restoration of an improved hemodynamic profile should be considered for urgent MCS as a bridge to decision. These patients should be referred to a center with expertise in the management of patients with advanced HF. (C)|
|Canadian HF guidelines|
|MCS may be offered to selected individuals with end-stage HF who are inotrope dependent and do not meet the traditional criteria for cardiac transplantation. (IIb-B)|
|ESC guidelines 2008/2010|
|Current indications for LVADs and artificial hearts include bridging to transplantation and managing patients with acute, severe myocarditis. (IIa-C)|
|Although experience is limited, these devices may be considered for long-term use when no definitive procedure is planned. (IIb-C)|
|LVAD may be considered as DT to reduce mortality. (IIa-B)|
Recommendations for MCS
- MCS for BTT indication should be considered for transplant-eligible patients with end-stage HF who are failing optimal medical, surgical, and/or device therapies and are at high risk of dying before receiving a heart transplant. (I-B)
- Implantation of MCS in patients before the development of advanced HF (ie, hyponatremia, hypotension, renal dysfunction, and recurrent hospitalizations) is associated with better outcomes. Therefore, early referral of advanced HF patients is reasonable. (IIa-B)
- MCS with a durable, implantable device for permanent therapy or DT is beneficial for patients with advanced HF, high 1-year mortality resulting from HF, and the absence of other life-limiting organ dysfunction who are failing medical, surgical, and/or device therapies and who are ineligible for heart transplantation. (I-B)
- Elective rather than urgent implantation of DT can be beneficial when performed after optimization of medical therapy in advanced HF patients who are failing medical, surgical, and/or device therapies. (IIa-C)
- • Urgent nondurable MCS is reasonable in hemodynamically compromised HF patients with end-organ dysfunction and/or relative contraindications to heart transplantation/durable MCS who are expected to improve with time and restoration of an improved hemodynamic profile. (IIa-C)
- These patients should be referred to a center with expertise in the management of durable MCS and patients with advanced HF. (I-C)
- Patients who are ineligible for heart transplantation because of pulmonary hypertension related to HF alone should be considered for bridge to potential transplant eligibility with durable, long-term MCS. (IIa-B)
- Careful assessment of RV function is recommended as part of the evaluation for patient selection for durable, long-term MCS. (I-C)
- Long-term MCS is not recommended in patients with advanced kidney disease in whom renal function is unlikely to recover despite improved hemodynamics and who are therefore at high risk for progression to renal replacement therapy. (III-C)
- Long-term MCS as a bridge to heart-kidney transplantation might be considered on the basis of availability of outpatient hemodialysis. (IIb-C)
- Assessment of nutritional status is recommended as part of the evaluation for patient selection for durable, long-term MCS. (I-B)
- Patients with obesity (BMI ≥30 to ≥40 kg/m2) derive benefit from MCS and may be considered for long-term MCS. (IIb-B)
- Assessment of psychosocial, behavioral, and environmental factors is beneficial as part of the evaluation for patient selection for durable, long-term MCS. (I-C)
- Evaluation of potential candidates by a multidisciplinary team is recommended for the selection of patients for MCS. (I-C)