NVR eNewsletter – 2020 Issue #7

AAA Devices and re-intervention dataset

Many vascular surgeons and interventional radiologists will have read “First Do No Harm”, the report of the Independent Medicines and Medical Devices Safety Review and it’s recommendations made by Baroness Cumberlege last week. A number of these have implications for our patients, particularly in relation to implantable medical devices.

To this end I am delighted to announce that the new AAA dataset goes live later today and will allow the capture of device specific information at the time of implant for both open surgical and endovascular AAA repair. Furthermore the dataset has been designed to record information on re-intervention and revision after previous AAA intervention and thus long-term device performance and patient outcomes with the ultimate goal of improved patient safety.

It became clear in 2017, following the recognition of the problems encountered with endovascular aneurysm sealing, that monitoring the performance of implantable medical devices in vascular surgery was vital to improve patient safety and outcomes. I was fortunate to spend time with the team at the National Joint Registry (NJR) in 2018, international leaders in patient centred, clinician led device surveillance and it became clear that the NJR model could be adapted for vascular surgery.

Over the last two years a lot of work has been undertaken behind the scenes to get to the point of a live dataset. I would to thank the NVR team, and in particular Sam Waton and David Cromwell for their hard work and support of this project. Multiple stakeholders have been involved from the outset and I would also like to thank Fiona Miller and more recently Richard O’Neill from the BSIR for their expertise and input. We have also sought and received support from HQIP, the MHRA, GIRFT and the National Director of Clinical Improvement for the NHS. Finally we have worked closely with the Association of British HealthTech Industries (ABHI) and Northgate, the IT provider of the NVR, specifically on the device capture aspects of the new dataset.

There will undoubtedly be some glitches and issues with the new dataset and we are very keen to receive comments and suggestions for improvement. The initial plan is to run the dataset as a pilot for 6-months and then analyse the data, with a view to modifying and improving the platform. It is vital that we capture data on the long-term performance of aortic prostheses and patient outcomes and we strongly encourage all clinicians providing aortic care to ensure the accurate capture of device information and re-interventions. In the longer-term we envisage developing the same model to capture devices implanted in carotid and peripheral vascular interventions.

Mr Jonathan Boyle, Chair of Audit and QI Committee of VSGBI and Clinical Lead of the NVR

 

To help with the introduction of the new dataset, we have produced a userguide.
We have also updated the AAA proforma and the NVR data dictionary.