New NICE Interventional procedures guidance [IPG611] Prostate artery embolisation for lower urinary tract symptoms caused by benign prostatic hyperplasia

Interventional procedures guidance [IPG611] Prostate artery embolisation for lower urinary tract symptoms caused by benign prostatic hyperplasia
Published date: April 2018


Evidence-based recommendations on prostate artery embolisation for lower urinary tract symptoms caused by benign prostatic hyperplasia in adults. This involves blocking the blood vessels supplying the prostate with tiny plastic particles.


for full guidance https://www.nice.org.uk/guidance/ipg611

New NICE Interventional procedures guidance [IPG609] Robot-assisted kidney transplant

New NICE Interventional procedures guidance [IPG609] Robot-assisted kidney transplant
Published date: April 2018, Next review: April 2021


Evidence-based recommendations on robot-assisted kidney transplant in adults. This involves the surgeon using a robot to help with a kidney transplant.


Read full guidance at  https://www.nice.org.uk/guidance/ipg609

Axitinib for Patients at High Risk of Recurrence of Renal Cell Carcinoma – Adjuvant

Renal cell carcinoma (RCC) is the most common type of kidney cancer. RCC affects the lining of tiny tubes within the kidney which filter waste from the blood, making urine. Symptoms include blood in urine, feeling of lump or mass in the kidney area, weight loss, raised temperature and sweating, back pain on one side (below the ribs), tiredness, loss of appetite and a general feeling of poor health. The main treatment for RCC is surgery to remove the cancer by partly or totally removing the kidney


http://www.io.nihr.ac.uk/report/axitinib-for-patients-at-high-risk-of-recurrence-of-renal-cell-carcinoma-adjuvant/


From the NIHR Innovation Centre

New NICE Technology appraisal guidance TA512: Tivozanib for treating advanced renal cell carcinoma.

Tivozanib for treating advanced renal cell carcinoma.


Evidence-based recommendations on tivozanib (Fotivda) for treating advanced renal cell carcinoma in adults.


Published: March 2018
Next review: March 2021


Full guidance available at https://www.nice.org.uk/guidance/ta512

UHCW publication: Haemodialysis acutely deteriorates left and right diastolic function and myocardial performance: an effect related to high ultrafiltration volumes?

Nephrol Dial Transplant. 2017 Aug 1;32(8):1402-1409. doi: 10.1093/ndt/gfw345.
Haemodialysis acutely deteriorates left and right diastolic function and myocardial performance: an effect related to high ultrafiltration volumes?
Sarafidis PA, Kamperidis V, Loutradis C, Tsilonis K, Mpoutsiouki F, Saratzis A, Giannakoulas G2, Sianos G, Karvounis H.
Read PubMed abstract at https://www.ncbi.nlm.nih.gov/pubmed/27738230

UHCW publication: Hemodynamic instability during dialysis

Hemodynamic instability during dialysis: is intra-dialytic exercise the answer?
Scott McGuire, Elizabeth Horton, Derek Renshaw, Alfonso Jimenez, Nithya S. Krishnan, Gordon McGregor
BioMed Research International 2018 Jan


Abstract
Acute haemodynamic instability is a natural consequence of disordered cardiovascular physiology during haemodialysis (HD). Prevalence of intra-dialytic hypotension (IDH) can be as high as 20-30%, contributing to sub-clinical, transient myocardial ischemia. In the long term, this results in progressive, maladaptive cardiac remodelling and impairment of left ventricular function. This is thought to be a major contributor to increased cardiovascular mortality in end stage renal disease (ESRD). Medical strategies to acutely attenuate haemodynamic instability during HD are sub-optimal. Whilst a programme of intra-dialytic exercise training appears to facilitate numerous chronic adaptations, little is known of the acute physiological response to this type of exercise. In particular, the potential for intra-dialytic exercise to acutely stabilise cardiovascular hemodynamics, thus preventing IDH and myocardial ischemia, has not been explored. This narrative review aims to summarise the characteristics and causes of acute haemodynamic instability during HD, with an overview of current medical therapies to treat IDH. Moreover, we discuss the acute physiological response to intra-dialytic exercise with a view to determining the potential for this non-medical intervention to stabilise cardiovascular haemodynamics during HD, improve coronary perfusion and reduce cardiovascular morbidity and mortality in ESRD.

Full text PDF available at http://downloads.hindawi.com/journals/bmri/aip/8276912.pdf (free access)

UHCW publication: gastric acid-reducing drugs following renal transplantation

Do stop me now: gastric acid-reducing drugs following renal transplantation

I Held, R Pyart J Kidney Care 2018 Jan 3(1):6-13

Abstract

Proton pump inhibitors (PPIs) can counteract the risk of gastrointestinal bleeds, but can also be harmful. University Hospitals Coventry and Warwickshire NHS Trust's renal transplant drug protocol recommends that patients take omeprazole if they have a history of peptic ulcers or indigestion. Ines Held and Rhodri Pyart share the findings of two audits on PPIs in renal transplant patients.

Full text available with UHCW Openathens login at https://www.magonlinelibrary.com/doi/10.12968/jokc.2018.3.1.6

Minimally invasive percutaneous nephrolitholapaxy medium (MIP-M) for removing kidney stones [MIB 138]

New:  Medtech innovation briefing


MIP‑M (Karl Storz, Germany) is a device used to remove kidney stones. MIP‑M is a miniaturised version of percutaneous nephrolithotomy (PCNL) and is suitable for people with kidney stones 12 to 24 mm in diameter in any renal calyx or in the renal pelvis. This device can be used on larger stones but this could increase the operative time and chances of complications. The MIP‑M device comprises a 12 Fr nephroscope, a 16.5/17.5 Fr operating nephrostomy or Amplatz sheath, a single-step dilator and grasping forceps.


The procedure is done by making a small incision, usually in the patient's back, and a needle is inserted into the renal pelvis. The position of the needle is confirmed by X‑ray or ultrasound. A guide wire is placed through the needle into the renal pelvis. It is then withdrawn, leaving the guide wire in place. A single-step dilator is passed over the guide wire to widen the access channel and a 16.5/17.5 Fr sheath is introduced. A miniaturised 12 Fr nephroscope is then passed inside the sheath; it allows the surgeon to see the kidney stones. The nephroscope has a channel through which grasping forceps are introduced to remove small stones. Bigger stones may have to be broken up using ballistic lithotripsy or laser treatments before removal. Ultrasound and laser instruments are also passed through the nephroscope channel.

Lenvatinib with everolimus for previously treated advanced renal cell carcinoma [TA 498]

New:  Technology appraisal guidance




Lenvatinib plus everolimus is recommended as an option for treating advanced renal cell carcinoma in adults who have had 1 previous vascular endothelial growth factor (VEGF)-targeted therapy, only if:

• their Eastern Cooperative Oncology Group (ECOG) performance status score is 0 or 1 and
• the company provides lenvatinib with the discount agreed in the patient access scheme.

1.2 This recommendation is not intended to affect treatment with lenvatinib plus everolimus 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.

Point-of-care creatinine tests before contrast-enhanced imaging [MIB 136]

New:  Medtech innovation briefing


POC creatinine tests allow rapid measurements of creatinine levels using very small samples of whole blood, serum, plasma or a combination of these. The devices used for these tests are either handheld or table-top and need blood from either finger-prick or venous/arterial samples. The method of analysis can vary with some devices using test cartridges and some using test strips.


The focus of this briefing is POC creatinine testing to assess kidney function in people who are scheduled to have contrast-enhanced imaging. Testing is important because contrast materials such as iodine or gadolinium can cause kidney injury, particularly in high-risk patients and those with known kidney dysfunction. If patients do not have a recent creatinine measurement, their imaging may be cancelled and rescheduled. Alternatively, they may have unenhanced imaging – which is less reliable – or the planned contrast agent may be given, risking kidney injury. Current practice varies; a recent UK survey estimated that up to 20% of hospitals only check creatinine levels before imaging in people known to be at high risk of kidney injury (Harris et al. 2016).

Lateral percutaneous nephrolithotomy: A safe and effective surgical approach

Indian Journal of Urology (INDIAN J UROL), Jan-Mar 2018; 34(1): 45-50

Percutaneous nephrolithotomy (PCNL) is traditionally performed with the patient in the prone position for large renal calculi. However, anesthetic limitations exist with the prone position. Similarly, the supine position is associated with poorer ergonomics due to the awkward downward position of the renal tract, a smaller window for percutaneous puncture, and a higher risk of anterior calyx puncture. This study aimed to demonstrate the feasibility and safety of lateral-PCNL in managing large renal calculi without the disadvantages of prone and supine positions.
UHCW Research: Jonathan Jian Wei Gan

New deal will give people with kidney cancer another treatment option

People with advanced kidney cancer are set to benefit from a new treatment, after NICE has said lenvatinib should be available on the NHS.

NICE recommends lenvatinib, also known as kisplyx, be given in conjunction with another drug called everolimus.

This drug-duo is recommended as an option for people who have previously been treated for advanced renal cell carcinoma (RCC).

Direct quantitative measurement of the kinetics of HLA-specific antibody interactions with isolated HLA proteins

Human Immunology, ISSN 0198-8859, http://dx.doi.org/10.1016/j.humimm.2017.10.012

HLA specific antibodies vary in their pathogenicity and this is likely to be the net effect of constant chain usage, quantity, specificity, and affinity. Here we have measured the affinity of human monoclonal antibodies for a range of HLA proteins. Purified antibodies and ligands allowed dynamic interactions to be measured directly by surface plasmon resonance. Physiochemical differences between pairs of ligands were quantified using electrostatic mismatch and hydrophobic mismatch scores.

All antibodies were characterized by fast on-rates and slow off rates but with a wide range of association rates (k _on, 3.63–24.25 × 10 ⁵ per mol per second) and dissociation rates (k _off , 0.99–10.93 × 10 ⁻³ per second). Dissociation constants (K _D ) ranged from 5.9 × 10 ⁻¹⁰ M to 3.0 × 10 ⁻⁸ M. SN320G6 has approximately a twenty-fold greater affinity for HLA A2 compared with SN607D8, but has a similar affinity for HLA-A2 and B57. In contrast, SN607D8 has greater than a twofold greater affinity for HLA-A2 compared with A68. Similarly, WK1D12 has about a threefold greater affinity for HLA-B27 compared with B7. The higher affinity interactions correlate with the specificity of stimulating antigen. This is the first study to directly measure the binding kinetics and affinity constants for human alloantibodies against HLA.

UHCW Research: Sunil Daga, Robert Higgins and Daniel Zehnder

Pentosan polysulfate sodium (Elmiron) for bladder pain syndrome (interstitial cystitis)

Pentosan polysulfate sodium is the only oral medication that has been developed for bladder pain syndrome. As well as relieving pain and urgency, it is also thought to help to repair the bladder lining. The drug is taken as oral capsules three times a day. If this medicine is launched in the UK, it will offer an additional treatment option for patients with painful bladder syndrome.


From the NIHR innovation Observatory

Topsalysin for benign prostatic hyperplasia

Benign prostatic hyperplasia (BPH) is a medical term that is used to describe enlargement of the prostate gland. It is not a cancer and is usually not a serious threat to health if well-treated. Most males aged 50 years and above will develop BPH. As the prostate gets bigger, it can place pressure on the bladder and it may squeeze or partly block the tube that carries urine from the bladder out of the body. This often causes problems with passing urine and may also cause other complications such as recurrent urinary tract infections, blockage of the bladder outlet, and kidney failure.
Topsalysin is a new medicine that is under development for the treatment of BPH. It acts on a specific receptor on the cell surface of prostate cells leading to shrinkage of these cells. It is delivered through an injection directly into the prostate, precisely shrinking the enlarged prostate tissue without damaging neighbouring tissue and nerves. This is believed to diminish the risk of side effects. If licensed, topsalysin will offer a new treatment option for patients with BPH.


From the NIHR Innovation Observatory

Immunosuppressive therapy for kidney transplant in children and young people [TA482]

New:  Technology Appraisal Guidance

Evidence-based recommendations  on immunosuppressive therapies for preventing kidney rejection in children and young people. The therapies are basiliximab (Simulect), immediate-release tacrolimus (Adoport, Capexion, Modigraf, Prograf, Tacni, Vivadex), mycophenolate mofetil (Cellcept and non-branded versions), rabbit anti-human thymocyte immunoglobulin (Thymoglobuline), prolonged-release tacrolimus (Advagraf, Envarsus), mycophenolate sodium (Myfortic, Ceptava), sirolimus (Rapamune), everolimus (Certican) and belatacept (Nulojix).

This guidance makes recommendations on using basiliximab, rabbit anti-human thymocyte immunoglobulin, tacrolimus (immediate-release and prolonged-release), mycophenolate mofetil, mycophenolate sodium, sirolimus, everolimus and belatacept after kidney transplant in children and young people. The recommendations apply only to the initial immunosuppressive therapy (induction and maintenance therapy) started around the time of kidney transplant.

It was outside the scope of the appraisal to make recommendations on using azathioprine or corticosteroids after kidney transplant in children and young people.
Under an exceptional directive from the Department of Health, the appraisal committee was allowed to make recommendations about using drugs outside the terms of their marketing authorisations if there was compelling evidence of their safety and effectiveness.

Immunosuppressive therapy for kidney transplant in children and young people [TA481]

New Guidance from NICE:

Evidence-based recommendations on immunosuppressive therapies for preventing kidney rejection in children and young people. The therapies are basiliximab (Simulect), immediate-release tacrolimus (Adoport, Capexion, Modigraf, Prograf, Tacni, Vivadex), mycophenolate mofetil (Cellcept and non-branded versions), rabbit anti-human thymocyte immunoglobulin (Thymoglobuline), prolonged-release tacrolimus (Advagraf, Envarsus), mycophenolate sodium (Myfortic, Ceptava), sirolimus (Rapamune), everolimus (Certican) and belatacept (Nulojix).

This guidance makes recommendations on using basiliximab, rabbit anti-human thymocyte immunoglobulin, tacrolimus (immediate-release and prolonged-release), mycophenolate mofetil, mycophenolate sodium, sirolimus, everolimus and belatacept after kidney transplant in children and young people. The recommendations apply only to the initial immunosuppressive therapy (induction and maintenance therapy) started around the time of kidney transplant.
It was outside the scope of the appraisal to make recommendations on using azathioprine or corticosteroids after kidney transplant in children and young people.
Under an exceptional directive from the Department of Health, the appraisal committee was allowed to make recommendations about using drugs outside the terms of their marketing authorisations if there was compelling evidence of their safety and effectiveness.

Immunosuppressive therapy for kidney transplant in adults

New Guidance from NICE:

Evidence-based recommendations on immunosuppressive therapies for preventing kidney rejection in children and young people. The therapies are basiliximab (Simulect), immediate-release tacrolimus (Adoport, Capexion, Modigraf, Prograf, Tacni, Vivadex), mycophenolate mofetil (Cellcept and non-branded versions), rabbit anti-human thymocyte immunoglobulin (Thymoglobuline), prolonged-release tacrolimus (Advagraf, Envarsus), mycophenolate sodium (Myfortic, Ceptava), sirolimus (Rapamune), everolimus (Certican) and belatacept (Nulojix).

This guidance makes recommendations on using basiliximab, rabbit anti-human thymocyte immunoglobulin, tacrolimus (immediate-release and prolonged-release), mycophenolate mofetil, mycophenolate sodium, sirolimus, everolimus and belatacept after kidney transplant in children and young people. The recommendations apply only to the initial immunosuppressive therapy (induction and maintenance therapy) started around the time of kidney transplant.
It was outside the scope of the appraisal to make recommendations on using azathioprine or corticosteroids after kidney transplant in children and young people.
Under an exceptional directive from the Department of Health, the appraisal committee was allowed to make recommendations about using drugs outside the terms of their marketing authorisations if there was compelling evidence of their safety and effectiveness.

Memokath-028, 044 and 045 stents for urethral obstruction [MIB123]

New NICE Advice Medtech innovation briefing

Memokath-028, 044 and 045 stents for urethral obstruction

The technologies described in this briefing are the Memokath‑028, Memokath‑044 and Memokath‑045 stents. They are used to relieve urethral obstructions and bladder neck or outlet obstructions.

The innovative aspects are that the stents are designed to be easily inserted and removed compared with other urethral stents or indwelling catheters.

Quality of life measures predict cardiovascular health and physical performance in chronic renal failure patients

PLoS One; San Francisco12.9 (Sep 2017): e0183926.

Patients with advanced chronic kidney disease (CKD) experience complex functional and structural changes of the cardiopulmonary and musculoskeletal system. This results in reduced exercise tolerance, quality of life and ultimately premature death. We investigated the relationship between subjective measures of health related quality of life and objective, standardised functional measures for cardiovascular and pulmonary health.

In CKD and HTN, objective physical performance has a significant effect on quality of life; particularly self-reported physical health and functioning. Therefore, these quality of life measures are indeed a good reflection of physical health correlating highly with objective physical performance measures.

UHCW Research: A. Rogan, K. McCarthy, C. McGregor, G. Evans, S. Hewins, N. Aldridge, S. Fletcher, N. Krishnan and R. Higgins