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Advanced heart failure: a position statement of the Heart Failure Association of the European Societ

Date: 2018-06-21
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Release date: 2018-05-21

Author: European Society of Cardiology(ESC)

Source: Crespo-Leiro MG, et al. Eur J Heart Fail. 2018. doi: 10.1002/ejhf.1236. [Epub ahead of print]

Abstract: This article updates the Heart Failure Association of the European Society of Cardiology (ESC) 2007 classification of advanced heart failure and describes new diagnostic and treatment options for these patients. Recognizing the patient with advanced heart failure is critical to facilitate timely referral to advanced heart failure centres. Unplanned visits for heart failure decompensation, malignant arrhythmias, co-morbidities, and the 2016 ESC guidelines criteria for the diagnosis of heart failure with preserved ejection fraction are included in this updated definition. Standard treatment is, by definition, insufficient in these patients. Inotropic therapy may be used as a bridge strategy, but it is only a palliative measure when used on its own, because of the lack of outcomes data. Major progress has occurred with short-term mechanical circulatory support devices for immediate management of cardiogenic shock and long-term mechanical circulatory support for either a bridge to transplantation or as destination therapy. Heart transplantation remains the treatment of choice for patients without contraindications. Some patients will not be candidates for advanced heart failure therapies. For these patients, who are often elderly with multiple co-morbidities, management of advanced heart failure to reduce symptoms and improve quality of life should be emphasized. Robust evidence from prospective studies is lacking for most therapies for advanced heart failure. There is an urgent need to develop evidence-based treatment algorithms to prolong life when possible and in accordance with patient preferences, increase life quality, and reduce the burden of hospitalization in this vulnerable patient population.

Short-term mechanical circulatory support

Intra-aortic balloon pump

Contribution of IABP to cardiac output is small, merely 0.5 L/min by some approximations. Currently, IABP are primarily used for cardiogenic shock in the setting of acute ischaemic heart disease, and for protective support during high-risk percutaneous coronary intervention, but scientific evidence for these applications is lacking. Intra-aortic balloon pumps are sometimes used to provide mechanical support to patients with cardiogenic shock prior to LVAD implantation, but the evidence for this practice is also limited. Newer devices that generate greater support and provide better unloading of the left ventricle are currently preferred.

Extracorporeal membrane oxygenation

Extracorporeal membrane oxygenation devices have a centrifugal blood pump that can provide up to 6 L/min of flow, as well as an oxygenator to provide full respiratory support. Thus, ECMO provides full systemic circulatory support and can be useful to restore end-organ perfusion. Extracorporeal membrane oxygenation can be used in either veno–arterial or veno–venous configurations. The veno–arterial mode provides full cardiopulmonary support, while the veno–venous mode provides only respiratory support. Complications of ECMO support are frequent and are mostly related to vascular complications, bleeding, thrombosis, and infections. ECMO can readily be used in cardiogenic shock caused by end-stage chronic heart failure as a short-term bridge-to-transplantation (BTT), BTD, or bridge-to-candidacy (BTC). Furthermore, ECMO provided better survival in patients in cardiogenic shock when compared to IABP.

TandemHeart® percutaneous ventricular assist device

TandemHeart is a device that connects the left atrium with the iliofemoral artery. A membrane oxygenator can be added to the TandemHeart circuit to provide respiratory support. TandemHeart has Food and Drug Administration (FDA) approval for 6 h of support and also CE mark, which includes approval for Protec Duo veno–venous cannula up to 30 days. The need for trans-septal puncture and positioning of the inflow cannula into the left atrium demands proficiency in its use. This makes the implant procedure more complex and longer as compared to other short-term percutaneously implanted devices. TandemHeart improves haemodynamics by adding up to 4 L/min of cardiac output and lowering pulmonary capillary wedge pressure. However, a positive effect on survival has not been established in studies performed to date.

Impella® ventricular support systems

The Impella device is a small axial flow pump placed across the aortic valve, aspirating blood from the left ventricle and expelling it to the ascending aorta. In this way, it unloads the left ventricle, improving haemodynamics combined with decreasing pulmonary capillary wedge pressure, and increasing coronary artery flow. Impella is manufactured in three versions: 2.5 device (12 Fr, maximum flow 2.5 L/min), CP device (14 Fr, maximum flow 2–4 L/min), and 5.0 device (21 Fr, maximum flow 5 L/min). The Impella device is FDA approved for partial support of up to 6 days, and it has a CE mark for up to 5 days. Impella has been shown also as an option for acute right ventricular support or for left ventricular unloading during ECMO.

CentriMag acute circulatory support system

The CentriMag is a magnetically levitated paracorporeal centrifugal pump which can be used for left ventricular, right ventricular, and biventricular support. Maximal flow is 10 L/min and duration of support is intended for up to 30 days, but longer is possible. This device can be used as a bridge-to-recovery or as a BTD for those patients who need a longer duration of support than is feasible by the previous mentioned devices. A new approach, minimally invasive CentriMag support integrated with ECMO (Ec-VAD) not requiring a sternotomy has been reported.

Long-term mechanical circulatory support

Continuous flow implantable MCS devices of the second and third generation have shown significant superiority over pulsatile first-generation implantable MCS devices. Currently, the three MCS devices most often used are the HeartMate II, HeartWare HVAD, and HeartMate 3. These devices have shown good durability, reasonable but still relatively high rates of device-related morbidity, improved functional capacity in implanted patients, and in the case of HeartMate 3, mid-term survival rates approaching that of post-transplant survival (overall 2-year survival of 83%).

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