2.1 The ENDURALIFE battery technology (Boston Scientific) is designed to extend the battery life of Boston Scientific cardiac resynchronisation therapy-defibrillator (CRT‑D) devices. CRT‑Ds are a treatment option for heart failure and life-threatening ventricular arrhythmias. ENDURALIFE battery technology uses a lithium manganese dioxide (Li/MnO2) battery chemistry, which is claimed to be less susceptible to the variations in voltage and resistance associated with early battery depletion. CRT‑Ds with ENDURALIFE battery technology are also claimed to use less current than other CRT‑Ds.
2.2 ENDURALIFE battery technology was first incorporated into the COGNIS CRT‑D device in February 2008. The ENDURALIFE brand was launched in 2015, but the technology has been in all Boston Scientific CRT‑Ds since 2008; the CE marks for the RESONATE, MOMENTUM, CHARISMA, VIGILANT, AUTOGEN, DYNAGEN, INOGEN, ORIGEN, INCEPTA, ENERGEN, PUNCTUA and COGNIS CRT‑Ds all include the ENDURALIFE battery technology. ENDURALIFE‑powered CRT‑Ds are CE-marked as class III medical devices.
2.3 According to the company's submission, the cost model uses an average industry-wide cost of £12,404 for a complete CRT‑D system. This cost was derived from the average selling prices used in the economic modelling for NICE technology appraisal guidance on implantable cardioverter defibrillators and cardiac resynchronisation therapy for arrhythmias and heart failure. The cost was inflated using the 2015 Bank of England inflation rate of 0.9%.
2.4 The claimed benefits of ENDURALIFE‑powered CRT‑Ds in the case for adoption presented by the company are:
Longer battery life for devices could help improve patient experience by increasing the time between replacements (meaning fewer overall replacement surgeries).
Fewer CRT‑D replacements could be particularly beneficial for patients with heart failure who are already very unwell and may have difficulty lying down for a long time.
Fewer replacements will also reduce the risk of complications, which is higher in replacement procedures than in primary implants. The increased risk of complications and infections can have a measurable impact on morbidity and mortality.
Fewer early replacements will lead to savings for the healthcare system, such as a reduction in hospital admissions, bed days and procurement costs. Fewer replacement procedures also means a reduction in associated costs such as post-operative complications and infections. Preliminary estimates suggest it could represent £33 million over 6 years.
Reduced replacement rates will allow more new patients to have implants within the same resource constraints, thus supporting the implementation of NICE's technology appraisal guidance on implantable cardioverter defibrillators and cardiac resynchronisation therapy for arrhythmias and heart failure and helping to meet the recommended levels of CRT‑D implants in the UK.
2.5 NICE has issued guidance on the management of chronic heart failure in adults. NICE technology appraisal guidance on implantable cardioverter defibrillators and cardiac resynchronisation therapy for arrhythmias and heart failure recommends CRT‑Ds as an adjunctive treatment option for heart failure in people on optimal medical therapy who have left ventricular dysfunction with a left ventricular ejection fraction of 35% or less.
2.6 Implantation of an ENDURALIFE‑powered device uses standard CRT‑D insertion techniques. Expert advisers have stated that people with a CRT‑D are typically followed-up by a physiologist in a technical device clinic and either a routine cardiology or specialist heart failure clinic. Patients with a CRT‑D usually attend a technical device clinic every 3 months, unless remote telemonitoring is used. It is recommended that patients should have one face-to-face technical device review annually. Patients will also need to be seen by a cardiologist; these clinics are dictated by clinical need/patient stability but are usually 6-monthly. When possible, the aim is to coincide the technical and cardiology clinics once a year. At each attendance, the patient's clinical status is noted and the device interrogated. Tests include the pacing function, the defibrillation leads (including lead impedance), the time spent pacing and the incidence of arrhythmias. The rate of battery depletion, and therefore the anticipated lifespan of the device, is also noted.
2.7 Remote device monitoring systems, which may reduce the need for technical device attendances, are available for all CRT‑Ds, including those with ENDURALIFE battery technology.