Implantation of a left ventricular assist device for destination therapy in people ineligible for heart transplantation

Evidence-based recommendations on implantation of a left ventricular assist device for destination therapy in people ineligible for heart transplantation.

# Recommendations
Current evidence on the efficacy and safety of the implantation of a left ventricular assist device for destination therapy in people ineligible for heart transplantation is adequate to support the use of this procedure provided that normal arrangements are in place for clinical governance, consent and audit. For people who are eligible for heart transplantation, refer to NICE's interventional procedure guidance on short-term circulatory support with left ventricular assist devices as a bridge to cardiac transplantation or recovery.
Patient selection should be done by a multidisciplinary team that includes a cardiologist with a specialist interest in heart failure, a cardiothoracic surgeon and a cardiac anaesthetist (see section 1.3).
Implantation of left ventricular assist devices for destination therapy should be done by surgeons, anaesthetists and intensive care specialists with special training and regular practice in performing this procedure and caring for these patients. Subsequent care should be provided by a multidisciplinary team including staff with the expertise to deal with patients' medical and psychological management, and with the maintenance of their left ventricular assist devices.
Clinicians should enter details on all patients who have a left ventricular assist device for destination therapy onto the UK Central Cardiac Audit Database.# Indications and current treatments
Heart failure is a complex clinical syndrome of symptoms that occur when the efficiency of the heart as a pump is impaired. It leads to reduced blood flow to the body tissues and increased filling pressure in the heart, which causes congestion and oedema in the lungs (causing breathlessness) or the body (causing swelling of the legs). Other symptoms include reduced exercise tolerance, fatigue and malaise.
Medical treatment of heart failure involves drugs such as diuretics and inotropic agents. Invasive therapies include electrophysiological interventions such as pacemakers and implantable cardioverter defibrillators, revascularisation by percutaneous coronary angioplasty and stenting or coronary artery bypass grafting, valve replacement or repair, and temporary use of intraaortic balloon pumps. In chronic heart failure, conventional treatment strategies may no longer work, resulting in the need for heart transplantation. Ventricular assist devices can be used to provide temporary circulatory support while a patient awaits heart transplantation (bridgetotransplantation).# The procedure
'Destination therapy' is a term that refers to the implantation of a left ventricular assist device (LVAD) with the aim of providing permanent circulatory support to people with advanced heart failure who are ineligible for heart transplantation. This guidance is based on evidence from studies in which the intended treatment strategy was destination therapy, and not bridgetotransplantation.
The LVAD is implanted with the patient under general anaesthesia and involves open heart surgery, usually with cardiopulmonary bypass. Initially, the pump component of the LVAD is placed in the pericardium. An inflow pipe is then inserted into the left side of the heart (usually the left ventricle) and an outflow pipe is inserted into the systemic arterial system (usually the aorta). Subsequently, a power cable, attached to the pump, is brought out of the abdominal wall to the outside of the body and attached to a control system and battery. Once the pump begins to work and support the heart, the cardiopulmonary bypass machine is removed and the chest incision is closed. The LVAD draws oxygenated blood from the failing left ventricle and pumps it into the systemic arterial system under pressure.
The first LVADs used pulsatile pumps that mimicked the natural pulsing action of the heart. Newer, more commonly used, devices use a rapidly spinning rotor to produce a continuous flow of blood into the systemic arterial system. Some people may also need simultaneous implantation of a second device to support right ventricular function.# Efficacy
This section describes efficacy outcomes from the published literature that the Committee considered as part of the evidence about this procedure. For more detailed information on the evidence, see the interventional procedure overview.
In a randomised controlled trial of 129 patients treated by pulsatileflow left ventricular assist device (LVAD) destination therapy (n=68) or optimal medical management (n=61), survival rates were 23% and 8% respectively at 2year followup (p=0.09). At 4year followup, survival rates were 16% in the pulsatileflow LVAD group and 8% in the optimal medical management group (no p value reported).
In a registry of 1287 patients treated by continuousflow (n=1160) or pulsatileflow (n=127) LVADs, survival rates were 76% and 68% respectively at 1year followup (p<0.0001). At 2year followup, survival rates were 67% in the continuousflow group and 45% in the pulsatileflow group (p<0.0001).
In a randomised controlled trial of 200 patients treated by continuousflow (n=134) or pulsatileflow LVADs (n=66), 6minute walking test distances improved from 182 m to 318 m (p<0.001) and 172 m to 306 m (p<0.001) respectively at 1year followup (p value between groups=0.22).
In the randomised controlled trial of 200 patients treated by continuousflow or pulsatileflow LVADs, mean Minnesota Living with Heart Failure questionnaire scores (scores range from 0 to 105, with lower scores indicating better quality of life) improved from 75.4 to 34.1 (p<0.001) and 76.1 to 44.4 (p<0.001) respectively at 1year followup (p value between groups=0.03). In the same study, mean overall Kansas City Cardiomyopathy questionnaire scores (scores range from 0 to 100, with higher scores indicating better quality of life) improved from 27.4 to 65.9 (p<0.001) in the continuousflow group and from 46.5 to 59.1 (p<0.001) in the pulsatileflow group at 1year followup (p value between groups=0.06).
In the randomised controlled trial of 129 patients treated by pulsatileflow LVAD destination therapy or optimal medical management, mean SF36 emotional domain scores (scores range from 0 to 100, with higher scores indicating better emotional outcomes) changed from 33 to 64 and from 25 to 17 respectively at 1year followup (p value between groups<0.05).
Specialist advisers listed key efficacy outcomes as: eventfree survival; cardiac output; exercise capacity; quality of life; and the 'potential for heart recovery'.# Safety
This section describes safety outcomes from the published literature that the Committee considered as part of the evidence about this procedure. For more detailed information on the evidence, see the interventional procedure overview.
Death caused by device failure was reported in less than 1% (6/1160) of patients treated by continuousflow left ventricular assist devices (LVADs) and 2% (3/127) of patients treated by pulsatileflow LVADs in a registry of 1287 patients at 2year followup. Death arising from loss of power to external components of LVADs was reported in 2% (9/414) of patients in a case series of 414 patients treated by continuousflow LVADs, at a minimum followup of 2 years.
Ischaemic stroke was reported in 8% (11/133) of patients treated by continuousflow LVADs and 7% (4/59) of patients treated by pulsatileflow LVADs at 2year followup in a randomised controlled trial of 200 patients (p=0.38). In the same study, haemorrhagic stroke was reported in 11% (15/133) of patients treated by continuousflow LVADs and 8% (5/59) of patients treated by pulsatileflow LVADs at 2year followup (p=0.33).
Right heart failure, managed by extended inotrope therapy, was reported in 20% (27/133) of patients treated by continuousflow LVADs and 27% (16/59) of patients treated by pulsatileflow LVADs at 2year followup in the randomised controlled trial of 200 patients (p<0.001). In the same study, right heart failure, treated by right ventricular assist devices, was reported in 4% (5/133) of patients treated by continuousflow LVADs and 5% (3/59) of patients treated by pulsatileflow LVADs at 2year followup (p=0.12).
Respiratory failure was reported in 38% (50/133) of patients treated by continuousflow LVADs and 41% (24/59) of patients treated by pulsatileflow LVADs at 2year followup in the randomised controlled trial of 200 patients (p<0.001).
Renal failure was reported in 16% (21/133) of patients treated by continuousflow LVADs and 24% (14/59) of patients treated by pulsatileflow LVADs at 2year followup in the randomised controlled trial of 200 patients (p<0.001).
Cardiac arrhythmia was reported in 56% (75/133) of patients treated by continuousflow LVADs and 59% (35/59) of patients treated by pulsatileflow LVADs at 2year followup in the randomised controlled trial of 200 patients (p=0.006).
LVAD-related infection was reported in 35% (47/133) of patients treated by continuousflow LVADs and 36% (21/59) of patients treated by pulsatileflow LVADs at 2year followup in the randomised controlled trial of 200 patients (p=0.01).
Pump replacement was needed for 9% (12/133) of patients treated by continuousflow LVADs and 34% (20/59) of patients treated by pulsatileflow LVADs at 2year followup in the randomised controlled trial of 200 patients (p<0.001).
Pump thrombosis was reported in 4% (5/133) of patients treated by continuousflow LVADs and 0% of patients treated by pulsatileflow LVADs at 2year followup in the randomised controlled trial of 200 patients (no p value reported).
Bleeding that needed blood transfusion was reported in 76% (315/414) of patients in the case series of 414 patients treated by continuousflow LVADs. In the same study, bleeding that needed surgical reexploration was reported in 23% (95/414) of patients (no further details were provided).
In addition to safety outcomes reported in the literature, specialist advisers are asked about anecdotal adverse events (events which they have heard about) and about theoretical adverse events (events which they think might possibly occur, even if they have never done so). For this procedure, specialist advisers did not list any anecdotal adverse events. They considered that aortic regurgitation was a theoretical adverse event.# Further information
For related NICE guidance, see the NICE website. For patients who are eligible for heart transplantation, see NICE's interventional procedure guidance on short-term circulatory support with left ventricular assist devices as a bridge to cardiac transplantation or recovery.

# Information for patients
NICE has produced information on this procedure for patients and carers (information for the public). It explains the nature of the procedure and the guidance issued by NICE, and has been written with patient consent in mind.# About this guidance
NICE interventional procedures guidance makes recommendations on the safety and efficacy of the procedure. It does not cover whether or not the NHS should fund a procedure. Funding decisions are taken by local NHS bodies after considering the clinical effectiveness of the procedure and whether it represents value for money for the NHS.
This guidance was developed using the NICE interventional procedures guidance process.
We have produced a summary of this guidance for patients and carers. Information about the evidence the guidance is based on is also available.
NICE produces guidance, standards and information on commissioning and providing highquality healthcare, social care, and public health services. We have agreements to provide certain NICE services to Wales, Scotland and Northern Ireland. Decisions on how NICE guidance and other products apply in those countries are made by ministers in the Welsh government, Scottish government, and Northern Ireland Executive. NICE guidance or other products may include references to organisations or people responsible for commissioning or providing care that may be relevant only to England.
ISBN: 978-1-4731-1084-7