Med Tech-related technology assessments and clinical guidelines from NICE in November 2021

In November 2021, NICE published two Interventional Procedures Guidance (IPG):

• Percutaneous implantation of pulmonary artery pressure sensors for monitoring treatment of chronic heart failure;
• Coronary sinus narrowing device implantation for refractory angina.

IPG is developed for most of the novel interventional procedures entering the English market. The program focuses solely on clinical evidence. Recommendations may vary from "for research only" to "for use with standard arrangements for clinical governance, consent, and audit." Recommendations are not binding, although they are followed by providers and commissioners.

NICE made the following conclusions:

• Evidence on the safety and efficacy is adequate to support using percutaneous implantation of pulmonary artery pressure sensors for monitoring treatment of chronic heart failure with standard arrangements for clinical governance, consent, and audit;
• Evidence on the safety of coronary sinus narrowing device implantation for refractory angina shows well-recognized complications. Evidence on efficacy is limited in quantity and quality. Therefore, this procedure should only be used with special arrangements for clinical governance, consent, and audit or research.

Medical Technologies Guidance (MTG) evaluates new, innovative medical devices and diagnostics. It looks at medical technologies that deliver treatment, like those implanted during surgical procedures, give greater independence to patients, or detect or monitor medical conditions.

In November 2021, NICE issued one new MTGs on Synergo for non-muscle-invasive bladder cancer. Synergo treats non-muscle-invasive bladder cancer using a radiofrequency-induced thermo-chemotherapeutic effect (RITE). NICE concluded that Synergo shows promise for high-risk non-muscle-invasive bladder cancer that has not responded to or has recurred after Bacillus Calmette-Guerin (BCG) treatment or when people cannot or do not want to have BCG treatment. However, there is not enough good-quality evidence to support the case for routine adoption. Synergo should only be used with special arrangements as outlined by NICE interventional procedures guidance on intravesical microwave hyperthermia and chemotherapy for non-muscle-invasive bladder cancer (IPG628). Further research is recommended.

The Diagnostic Guidance (DG) program focuses on evaluating innovative medical diagnostic technologies to ensure that the NHS can adopt clinically and cost-effective technologies rapidly and consistently.

In November 2021, NICE published one new DG on SeHCAT (tauroselcholic [75 selenium] acid) for diagnosing bile acid diarrhea. NICE concluded that there is not enough evidence to recommend routine use of SeHCAT for diagnosing bile acid diarrhea in people with 1) chronic diarrhea of unknown cause, suspected or diagnosed diarrhea-predominant irritable bowel syndrome (IBS-D) or functional diarrhea; 2) Crohn's disease without ileal resection who have chronic diarrhea. Centers already using SeHCAT for diagnosing bile acid diarrhea may continue to do so but must collect further data or do further research. Further data collection and research are being recommended.

The MedTech Innovation Briefings (MIBs) is the advice program of NICE for innovative technologies. It provides an overview of clinical effectiveness, safety, and cost. It does not offer formal guidance, and it, therefore, does not provide any recommendations. The four new MIBs published in November 2021 are:

• clonoSEQ for minimal residual disease assessment in multiple myeloma, acute lymphoblastic leukaemia and chronic lymphocytic leukaemia. It leverages the power of next-generation sequencing (NGS) to assess the presence of malignant cells at levels below the detection limit of conventional cytomorphological methods;
• CerebAir for continuous EEG monitoring in intensive care, a wireless headset with pre-positioned electrodes, which is designed to be quicker and easier to apply than conventional continuous EEG. Specialist training is not needed to apply the headset, and data can be reviewed by neurophysiologists remotely;
• 24/7 EEG SubQ for epilepsy, a subcutaneous electroencephalogram (EEG) recording device that allows ultra-long-term monitoring (30 days and over) in home settings;
• Paige Prostate for prostate cancer, an artificial intelligence (AI)-based system for the assessment of cancer in prostate biopsies.

Three new clinical guidelines were published in November 2021:

• Heart valve disease presenting in adults: investigation and management. The guideline provides recommendations on assessment, interventions (including TAVI, aortic valve replacement, mitral valve repair and replacement, tricuspid valve repair), monitoring after interventions, and others. Interventions are recommended for adults with symptomatic severe heart valve disease. When surgery is agreed upon, the decision on the type of approach (median sternotomy or minimally invasive surgery) is based on patient characteristics and preferences;
• Tobacco: preventing uptake, promoting quitting and treating dependence;
• Inducing labor.

Six clinical guidelines were updated in November 2021:

• Fever in under 5s: assessment and initial management. Minor updates;
• Ectopic pregnancy and miscarriage: diagnosis and initial management. Updates were only concerned pharmacotherapy;
• Chronic kidney disease: assessment and management. Updates were only concerned pharmacotherapy;
• Type 2 diabetes in adults: management. Updates were only concerned pharmacotherapy;
• Acute heart failure: diagnosis and management. The recommendations on valvular surgery and percutaneous intervention were withdrawn because they have been replaced by the NICE guideline on heart valve disease (see above);
• COVID-19 rapid guideline: managing the long-term effects of COVID-19. New recommendations and updated existing recommendations were made on identification, planning care, multidisciplinary rehabilitation, follow-up, monitoring and discharge, and service organization.

See the full details for guidance here. and for MIBs here

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