Latest reports from the Advisory Committee on the Safety of Blood, Tissues and Organs (SaBTO)

The reports set out the work of the Advisory Committee on the Safety of Blood, Tissues and Organs (SaBTO) during 2014 to 2017 and can be accessed at https://www.gov.uk/government/publications/sabto-annual-reports

SaBTO microbiological safety guidelines 2017

Guidance from the Department of Health and Social Care on the microbiological safety of human organs, tissues and cells used in transplantation.

Artificial heart implantation as a bridge to transplantation for end-stage refractory biventricular heart failure [IPG602]

New interventional procedures guidance from NICE.  This involves replacing the 2 lower chambers of the heart with a mechanical device to improve circulation until heart transplantation.

Current evidence on the safety and efficacy of total artificial heart implantation as a bridge to transplantation for end-stage refractory biventricular heart failure is limited in quality and quantity. Therefore, this procedure should only be used with special arrangements for clinical governance, consent and audit or research.

Clinicians wishing to do total artificial heart implantation as a bridge to transplantation for end-stage refractory biventricular heart failure should:

• Inform the clinical governance leads in their NHS trusts.
• Ensure that patients understand the uncertainty about the procedure's safety and provide them with clear written information. In addition, the use of NICE's information for the public is recommended.
• Audit and review clinical outcomes of all patients having total artificial heart implantation as a bridge to transplantation for end-stage refractory biventricular heart failure (see section 6.3).
• Clinicians should enter details about all patients having total artificial heart implantation as a bridge to transplantation for end-stage refractory biventricular heart failure onto an appropriate registry and review local clinical outcomes.
• Patient selection should be done by a multidisciplinary team experienced in managing end-stage refractory biventricular heart failure in patients needing a heart transplant, for whom a donor organ is not expected to be available before their own heart fails completely.
• This technically challenging procedure should only be done in centres specialising in heart transplantation. Only cardiothoracic surgeons with specific expertise and training in inserting the device should carry it out.

Gadolinium contrast agents and risk of tissue accumulation—removal of Omniscan and intravenous Magnevist from February; restrictions to use of other linear agents

From 1 February 2018, intravenous forms of gadodiamide (Omniscan) and gadopentetic acid (also known as gadopentetate dimeglumine; intravenous Magnevist) linear contrast agents for MRI will no longer be licenced and any remaining stock will be recalled from the market. The authorised indication of the linear agents gadobenic acid (also known as gadobenate dimeglumine; MultiHance) and gadoxetic acid (Primovist) will be limited to delayed phase liver imaging only.

Introducing 'opt-out' consent for organ and tissue donation in England

This DH consultation seeks views on proposed plans to make it easier for people to give consent to be an organ donor.

The consultation is specifically seeking input on how much input families have in deceased relative's donation decisions, whether exemptions to opting out is needed and how these proposals may affect certain groups depending on age, disability, race or faith. The consultation closes on 6 March 2018.

Tissue pathway for histopathological examination of the placenta

This tissue pathway from the Royal College of Pathologists aims to provide guidance on the range of indications for referral of aplacenta for histopathological examination and minimum standards for pathologists undertaking placental examinations. Variations to the standard pathway for singleton placentas, relating to pregnancies from multiple gestations, are also included. Please note that products of conception (1st trimester) have been included in the tissue pathways for gynaecological pathology.

Visceral adiposity index and 10-year cardiovascular disease incidence: The ATTICA study

Nutrition, Metabolism & Cardiovascular Diseases (NUTR METAB CARDIOVASC DIS), Oct2017; 27(10): 881-889

Visceral adiposity index (VAI) has been proposed as a marker of visceral adipose tissue accumulation/dysfunction. Our aim was to evaluate potential associations between the VAI and the 10-year cardiovascular disease (CVD) incidence.

UHCW Research: I Kyrou, 

Rapidly enlarging lipoma

BMJ Case Reports (BMJ CASE REP), 9/22/2017; 2017: 1-2

Lipoma is a common subcutaneous tumour composed of fat tissue. It may occur as a sporadic solitary lesion or as multiple lesions. They often grow very slowly. They vary between 2 and 10 cm in size. There are rarely any subjective symptoms. Lipomas do not usually require treatment unless they are big enough to be symptomatic. We reported a 75-year-old man with a rapidly enlarging and ulcerated mass on his right upper thigh.

UHCW Research: Dr Timea Kosztyuov and Tang Ngee Shim

Revised British Society of Gastroenterology recommendation on the diagnosis and management of Barrett’s oesophagus with low-grade dysplasia

The most recent guidelines for the managementof Barrett’s oesophagus published in 2014 recommended endoscopic surveillance for patient with histological evidence of low-grade dysplasia (LGD) on random biopsies.1 In the last 2 years, new evidence on the natural history of LGD in Barrett’s oesophagus and on the safety and efficacy of endoscopic treatment in this subgroup of patients has been published.

Health Secretary challenges NHS to deliver digital services nationwide

By the end of 2018 – the 70th birthday year of the NHS – the Health Secretary said he expects every patient in England to be able to do the following online through an app:

• access NHS 111
• access their healthcare record
• book a GP appointment
• order repeat prescriptions
• express their organ donation preferences
• express their data sharing preferences
• access support for managing a long term condition

Commissioning policy: Reimbursement of expenses for living donors

This is an NHS England policy designed to inform healthcare professionals and commissioning authorities about the principles and processes that underpin financial reimbursement for living organ donors.

Olaratumab in combination with doxorubicin for treating advanced soft tissue sarcoma [TA465]

Olaratumab, in combination with doxorubicin, is recommended for use within the Cancer Drugs Fund as an option for advanced soft tissue sarcoma in adults, only if:

• they have not had any previous systemic chemotherapy for advanced soft tissue sarcoma
• they cannot have curative treatment with surgery or their disease does not respond to radiotherapy
• the conditions in the managed access agreement for olaratumab are followed. Olaratumab in combination with doxorubicin for treating advanced soft tissue sarcoma

This recommendation is not intended to affect treatment with olaratumab that was started in the NHS before this guidance was published. People having treatment outside this recommendation may continue without change to the funding arrangements in place for them before this guidance was published, until they and their NHS clinician consider it appropriate to stop.

Olaratumab in combination with doxorubicin for treating advanced soft tissue sarcoma - guidance (TA465)

New technology appraisal guidance from NICE on olaratumab (Lartruvo) plus doxorubicin for treating advanced soft tissue sarcoma in adults.

Olaratumab, in combination with doxorubicin, is recommended for use within the Cancer Drugs Fund as an option for advanced soft tissue sarcoma in adults, only if:

• they have not had any previous systemic chemotherapy for advanced soft tissue sarcoma
• they cannot have curative treatment with surgery or their disease does not respond to radiotherapy
• the conditions in the managed access agreement for olaratumab are followed.

Pembrolizumab and olaratumab now available on the CD

Pembrolizumab (Keytruda) for lung cancer and olaratumab (Lartruvo) for sarcoma are now available on the CDF while more data is gathered on their value. Both drugs will remain on the CDF until they are reviewed again by NICE.

Pembrolizumab is used to treat advanced lung cancer in people who have specific protein and genetic markers. It was recently recommended by NICE as a second line option for some patients with lung cancer. This new guidance is for those with untreated lung cancer which could see around 1,400 new patients benefiting from this treatment.

Brown fat depots in adult humans remain static in their locations on PET/CT despite changes in seasonality

Physiological Reports Published 6 June 2017 Vol. 5 no. e13284 DOI: 10.14814/phy2.13284

Active brown adipose tissue (BAT) in humans has been demonstrated through use of positron emission tomography with 2‐deoxy‐2‐(fluorine‐18) fluoro‐D‐glucose integrated with computed tomography (18F‐FDG PET/CT) scans. The aim of our study was to determine whether active human BAT depots shown on 18F‐FDG PET/CT scans remain static in their location over time.

UHCW Research: Terence A. Jones, Sarah C. Wayte, Oludolapo Adesanya and Charles E. Hutchinson

Innovation In Regulation

The Human Fertilisation and Embryology Authority (HFEA) and the Human Tissue Authority (HTA) have published documents showing how their approach to regulation supports innovation.

• HFEA strategy
• HTA strategy

Reprogramming of the retinoic acid pathway in decidualizing human endometrial stromal cells

PLOS One March 2, 2017 http://dx.doi.org/10.1371/journal.pone.0173035

Upon breaching of the endometrial surface epithelium, the implanting embryo embeds in the decidualizing stroma. Retinoic acid (RA), a metabolite of vitamin A, is an important morphogen during embryonic and fetal development, although the role of the RA pathway in the surrounding decidual cells is not understood. Here we show that decidual transformation of human endometrial stromal cells (HESCs) results in profound reprogramming of the RA signaling and metabolism pathways.

UHCW Research: Jan J Brosens

Red cell washing for the prevention of transfusion- associated organ injury in cardiac surgery: The REDWASH Trial

Transfusion Medicine. Volume 26, Issue S2 September 2016  Pages 25–58 DOI: 10.1111/tme.12342
Abstracts of the Annual Scientific Meeting of the British Blood Transfusion Society, 21–23 September 2016, Harrogate

Poster: this study assessed whether the removal of pro-inflammatory substances that accumulate in stored donor red cells by mechanical cell washing would attenuate platelet and leucocyte activation, inflammation and organ injury post cardiac surgery.

UHCW Research: S. K. Budhia

Skin involvement in systemic sclerosis: rituximab

This evidence summary from NICE includes 7 studies that investigated rituximab (usually 375 mg/m2 weekly for 4 weeks at 0 and 6 months, or 1,000 mg at 0 and 2 weeks) for treating skin involvement in systemic sclerosis (mainly diffuse).

Latest Pharmacological Technology Briefings - February 2017

NIHR Horizon Scanning Research and Intelligence Centre's latest batch of briefings on pharmacological technologies in development is now available:

• Anacetrapib in combination with a statin for patients with primary hypercholesterolaemia or mixed dyslipidaemia – adjunctive therapy
• VTS-270 for Niemann-Pick disease type C1
• Talacotuzumab with decitabine for acute myeloid leukaemia
• Pembrolizumab (Keytruda) for locally advanced melanoma – adjuvant therapy
• Nivolumab for small cell lung cancer in combination with ipilimumab – first line maintenance therapy
• Nivolumab for small cell lung cancer in combination with ipilimumab – second line
• Nivolumab with ipilimumab for advanced non-small cell lung cancer – first line
• Mirogabalin for pain due to fibromyalgia
• Liraglutide (Victoza) to reduce the risk of cardiovascular events in patients with type 2 diabetes mellitus
• Ibrutinib (Imbruvica) for newly diagnosed mantle cell lymphoma
• Eltrombopag (Revolade) for severe aplastic anaemia – first line
• Durvalumab (MEDI4736) for non-small cell lung cancer – adjuvant treatment following surgery
• Dapagliflozin (Forxiga) for type 1 diabetes mellitus – add-on to insulin therapy
• Cinryze (C1 inhibitor) for treatment and prevention of recurrent attacks of hereditary angioedema in children
• Budesonide orodispersible tablet for eosinophilic oesophagitis – first line
• Avelumab for advanced non-small cell lung cancer — first line