Watch a trailer
Safety & Qaulity / Regstries & Audit (Governance, QI, MHRA, Registries)
MHRA update on COVID-19
Please click HERE for recently published MHRA guidance on coronavirus (COVID 19) aimed at supporting healthcare partners.
BSIR Venous Registry
Dear BSIR and VS members,
We are pleased to announce that the BSIR venous registry has now been relaunched and it is again possible to enter patient data. This registry is intended to capture data on venous interventions, primarily for the treatment of lower limb DVT.
NICE IPG651 (2019) recommends that the details of all patients undergoing mechanical thrombectomy should be entered into the registry
You will need to request new user access. Links to obtain these are included below and are also available on the BSIR and VS websites. The registry is run by Netsolving via the Casecapture platform
Direct access to the registry
https://data.casecapture.com/
The registry was suspended to resolve and clarify patient consent for data retention. That process has now been completed. Further details are available on the BSIR website. The consent forms and patient information leaflets are available to download from the BSIR, VS and Casecapture websites.
BSIR Registries & Audit committee
It’s here! Vascular research priorities survey round 2 – please share with your patients
Dear BSIR members,
Please can you help to ensure your Vascular unit and your patients are represented by helping to promote the research prioritisation second round survey to your vascular patients and carers.
Patients with any vascular condition are invited to rate a list of proposed research questions, based on what is important to them. These questions were generated by patients and carers themselves in an earlier round of survey. They have been analysed, summarised and duplication removed, in preparation for this prioritisation round of survey.
What can I do to help? There are lots of ways you can help.
Share the survey:
Encourage your patients, their carers and families to complete and share electronic link: https://york.qualtrics.
A paper version and promotional materials can be downloaded directly from the project website: https://www.hyms.ac.
or you can email Judith.long@hey.nhs.uk
1. In a rush and want to help? Ctrl + click to send one of these tweets:
It’s here! Your chance to influence research in vascular
Vascular patients and carers help to prioritise future research
Encourage followers to share with ‘please RT’, tag your participating organisation such as @VSGBI @vascularnurses @svtgbi @VascResearchNet @BACPAR_official @BSIR_News
2. Post this message in relevant on-line forums and support groups:
The Vascular Research Priority Setting Partnership wants to hear from vascular patients, carers and family members. This is your chance to help inform future research so that it focuses on what matters most to those accessing vascular services. Complete the survey at: Vascular Research Priorities Survey
3. Use our posters and hard copies of the survey:
On our website, we have downloadable versions of posters and copies of the survey, that can be sent to us via email or post: https://www.hyms.ac.uk/r
The success of this project absolutely depends on the involvement of all UK vascular units and vascular specialists in helping us to reach as many different vascular patients as possible. We really appreciate your help.
Thank you for your support.
BSIR Venous Registry
Dear Members,
The BSIR Registries & Audit Committee are pleased to announce the launch of the BSIR Venous Registry, which is accessible to all clinicians managing patients with acute iliofemoral DVT and symptomatic chronic iliofemoral venous outflow obstruction (Interventional Radiologists, Vascular Surgeons and Haematologists).
Current NICE guidance recommends Clinicians to enter details of all patients undergoing percutaneous mechanical thrombectomy for acute iliofemoral DVT on this Registry.This Registry will also collect data on patients undergoing percutaneous image-guided interventions in symptomatic chronic post-thrombotic and non-thrombotic iliofemoral venous outflow obstruction.
The main objective of the Registry is to improve quality of care by evaluating outcomes and assessing the safety of interventions in acute and chronic iliofemoral venous obstruction.
To apply for user access please click HERE.
Kind regards
Julie Ellison
BSIR Director of Operations
Paclitaxel Patient Letter V4040619 (1)
Dear BSIR Member
It is appreciated that the recent MDA from MHRA regarding drug eluting stents and drug coated balloons may mean that Trusts and departments want to write to/contact patients. To try to help reduce the potentially repetitive workload of formulating a letter, a group of IRs and Vascular Surgeons have put together the attached (click HERE to view). Undoubtedly individual organisations will want to produce their own version, or may not wish to write, but we offer the attached as a way to try to help. We hope you find it of assistance, if not, please feel free to ignore it.
Dr Trevor Cleveland
BSIR President
Medical Device Alert MDA/2019/023
After careful consideration and consultation, the MHRA has issued a Device Alert, published on 4th June 2019, relating to drug eluting technologies. Members are advised to take note of the content, and make arrangements as they see fit, in the light of the Alert.
To view the alert please click HERE.
Dr Trevor Cleveland
BSIR President
New Guidance on Picture archiving and communication systems and guidelines on diagnostic display devices from the Royal College of Radiologists
Please click HERE to view RCR New Guidance on Picture archiving and communication systems and guidelines on diagnostic display devices
New Guidance on Picture archiving and communication systems and guidelines on diagnostic display devices from the Royal College of Radiologists
Please click HERE to view RCR New Guidance on Picture archiving and communication systems and guidelines on diagnostic display devices
BSIRs Statement regarding Drug Eluting Technologies
Click HERE to view / download BSIRs Statement regarding Drug Eluting Technologies
Click HERE to view / download FDA Letter to Healthcare Professionals onTreatment of PAD with Paclitaxel-Coated Balloons and Stents
NCEPOD Common Themes
Dear BSIR member,
I would like to commend to you, and suggest taking a few minutes to read, the attached.
This is the NCEPOD Themes and Recommendations Common to all Hospital Specialties.
It is a review of the most common recurring themes seen in the many NCEPOD Reports.
The entire document is relevant, but I would draw your attention specifically to 2 themes:
Theme 5 – Consent. Among the notes there is a very clear support of the GMC guidance on taking consent and who should do this. In elective cases a deferred two stage process is recommended and also that consent on the day is not seen as appropriate. This is a very clear statement of need for IR clinics for non-emergency care.
Theme 9 – Managed Clinical Networks. Again it has been clear that formal network arrangements need to be in place to allow patients to have access to the appropriate treatment. Ad-hoc arrangements are not considered suitable, and that Trusts need to have a clear refer and transfer policy. Again, I’m sure that this will ring in the ears of all of you, both in hubs and spokes, as there often in not a clear process for referral and transfer, leading to unnecessary delay (or even denial) of important IR procedures.
I am sure that there are a number of other areas in this document that you might find helpful in supporting your quality improvement programmes.
Best wishes
Trevor Cleveland
BSIR President
NCEPOD Common Themes
SIRT registry for the CtE cases
This is the article from the SIRT registry for the CtE cases, published October 2018.
Retained interventional radiological sheaths in obstetric cases Final
The below has been forwarded to BSIR from the Patient Safety Team at NHS Improvement The Safety and Quality Committee and Council Officers wish to make members aware of the review, and to bring the subsequent reflections to the attention of BSIR members.
NHS Improvement - Patient Safety Alert - Confirming removal or flushing of lines and cannulae after procedures
Please see below Patient Safety Alert - Confirming removal or flushing of lines and cannulae after procedures, from NHS Improvement for your information.
Analysis of Thrombolysis in acute DVT Surveys
Dear Colleagues,
I would like to offer my sincere apologies for the delay in the publication of the analysis of my two recent Surveys about Thrombolysis in acute DVT and the second on the possible reasons behind not providing this service. Also, I would like to thank those who participated in these surveys.
Since the introduction of NICE guideline* for Thrombolysis in acute Ilio-Femoral DVT in 2012, a selection of Interventional radiologists (IR) started providing this form of treatment to patients with a history of DVT of less than 2 weeks’ duration.
The second survey showed that several IR’s colleagues have shown an interest in providing this form of treatment even though a small number (22%) are put off by the recent presentation of ATTRACT trial which claimed that there was no benefit in acute DVT thrombolysis in terms of preventing Post Thrombotic syndrome (ATTRACT fails to meet primary endpoint, but experts agree results are “hypothesis-generating” Vascular News 6th March 2017).
The purpose of both surveys is to pave the way to establish a registry on Thrombolysis in acute Ilio-Femoral DVT sponsored by BSIR. The surveys show that a number of Interventional radiologists and vascular surgeons, albeit small, do offer both Mechanical and or Catheter directed Thrombolysis.
As you can see from my summary report below, we are all providing the recommended pathway of treatment and utilizing available technologies to achieve the best outcomes. However, to gain some insight into the efficacy of these techniques, I would recommend a formal registry, run by the BSIR. I would recommend at least two years’ follow up. In addition, the registry is going to be used as a tool to determine how we define a successful primary outcome (i.e. preserved valve function, speed of flow, absence of reflux and whether there is a residual clot or stenosis) and whether this translates into good medium to long term outcomes.
Meanwhile, there are two controversial issues which require a consensus. The first issue is related to the use of IVC filter prior to thrombolysis and rather than putting my views on this topic I would like to share with you several publications on this issue which are worth reading:
PREPIC-1 (Decousus et al. A clinical trial of vena caval filters in the prevention of pulmonary embolism in patients with proximal deep vein thrombosis. NEJM 1998; 338:409)
PREPIC-1 Follow-Up Study (Eight-year follow-up of patients with permanent vena cava filters in the prevention of pulmonary embolism. Circulation 2005; 112: 416-422)
PREPIC-2 (Effect of a retrievable inferior vena cava filter plus anticoagulation vs. anticoagulation alone on risk of recurrent pulmonary embolism: A randomized clinical trial. JAMA 2015; 313: 1627)
Prasad V, Rho J, Cifu A. The IVC Filter: How could a medical device be so well accepted without any evidence of efficacy? JAMA Internal Medicine 2013; 173(7) 493-495.
The second issue which is equally very important and is to do with the future follow up of our patients following thrombolysis and whose responsibility it is.
Please, enjoy reading the analysis of the surveys’ outcomes and don’t hesitate to reply with your invaluable thoughts and suggestions on what questions should be included in any planned future registry.
Best wishes
Said Habib
Consultant IR, Nottingham University Hospitals
*NICE guideline:
Deep vein thrombosis
1.2.6Consider catheter-directed thrombolytic therapy for patients with symptomatic iliofemoral DVT who have:
- symptoms of less than 14 days' duration and
- good functional status and
- a life expectancy of 1 year or more and
- a low risk of bleeding. [2012]
Data capture paper tool for NVR
Please find attached a paper consent and data collection tool that you may find helpful in data collection for peripheral angiographic procedures for the NVR. While this document does not circumvent the requirement for eventual electronic data submission, we hope that IRs will find it useful to collect data immediately after a procedure. Ideally some administrative support should be made available by trusts to enable data entry direct from the document without the need for the IR to do this personally.
The BSIR is progressing a number of other projects that may eventually assist in electronic data entry.
Yours faithfully
Chris Hammond
Chair: BSIR R&A Committee
Out Of Hours Intervention for Haemorrhage October 2016 - Snapshot Survey Results
Please see attached a summary of results of the OOH intervention for haemorrhage snapshot survey done in October 2016.
Chris Hammond
Chair: BSIR R&A Committee
