National registry will record patients’ outcomes from devices implanted during vascular surgery

Key details of medical devices implanted in patients during abdominal aortic aneurysm repair are to be included in a national database from today.  These new additions to the database will also monitor long-term patient outcomes to identify problems as early as possible.  This comes shortly after the Cumberlege review where it was recommended that ‘a central database should be created by collecting key details including the patient, the implanted device, and the surgeon.’

The National Vascular Registry (NVR) was created in 2013 to provide NHS vascular units with information on their performance and to support their quality improvement initiatives.

From today, the NVR will include information on conventional vascular grafts which are used to repair abdominal aortic aneurysms (AAA)¹ and stent-grafts used for keyhole, endovascular AAA repair (EVAR)¹. The aim of including this information in the registry is to help track the long-term outcomes of patients who have had aortic devices implanted and to identify as early as possible if a device is failing.  This will allow patients with these devices to be closely monitored and prevent device use in future patients if problems are identified.

Earlier this month, the Independent Medicines and Medical Devices Safety Review (IMMDS) made a series of recommendations in its report, ‘First do no harm^2.  The report followed an independent review, led by Baroness Cumberlege, into the adverse impact three medical interventions had on patients: Primodos, sodium valproate and pelvic mesh.  To improve patient safety, the Review recommended that: ‘a central database should be created by collecting key details including the patient, the implanted device, and the surgeon’.  The Royal College of Surgeons of England made this recommendation in evidence given to the Review last year³. By including information on aortic devices in its national database, the National Vascular Registry fulfils this recommendation.

Mr Jon Boyle, a Consultant Vascular Surgeon, Clinical Lead of the NVR and Vice-President-elect of the Vascular Society of Great Britain and Ireland (VSGBI), said: “The Cumberlege report documented harrowing testimonies from patients who had been badly let down by the health service.  Among the problems highlighted was a failure to monitor implanted medical devices so that any reported problems could be quickly identified.

“We want to provide patients undergoing abdominal aortic aneurysm repair with the best care and information possible. We therefore need to capture device information of grafts and stent-grafts both at the time of implantation and also afterwards, by monitoring long-term performance.  This will enable us to quickly identify if a particular device is failing, and should help reduce ‘revision rates’ of surgery – where a patient has to have a repeat operation. This patient-centred, clinician-led initiative is a major step forward for the safety of patients having vascular surgery.”

Professor Neil Mortensen, President of the Royal College of Surgeons of England said:

“The enhancements to the National Vascular Registry will help track the long term outcomes of patients who have a stent graft implanted during abdominal aortic aneurysm repair surgery. This type of national, system-wide monitoring is critical to identifying any problems with devices sooner, and therefore to improving patient safety.

“We urge the Government to support the establishment and development of more registries, and also to implement Baroness Cumberlege’s recommendation to establish a central database of implants and devices. The Medicines and Medical Devices Bill going through Parliament now should be used to achieve this without delay.”

In the longer term, the National Vascular Registry plans to expand the database to capture devices implanted in carotid and peripheral vascular interventions.

Notes to editors

1. An abdominal aortic aneurysm (AAA) is a swelling in the aorta, the main blood vessel that runs from the heart down through the chest and tummy.An AAA can be dangerous if it is not detected early.The risk is that it will get bigger over time and burst, causing life-threatening bleeding. Surgery is recommended for a large AAA of 5.5cm. This involves inserting an artificial artery called a stent graft to keep the aorta open.There is more information on endovascular aneurysm repair and open AAA operation.

    

2. The report of the IMMDS review is published here. 

    

3. RCS England’s previous past President, Professor Derek Alderson gave evidence to Baroness Cumberlege’s review in February 2019. This is available to watch here.

    

4. The Vascular Society of Great Britain and Ireland is the specialist society that represents vascular surgeons. It is one of the key partners leading the National Vascular Registry Audit. This contains information on the care pathways and outcomes for patients undergoing a revascularisation procedure including: angioplasty/stent or bypass surgery, or major amputation for lower limb peripheral arterial disease (PAD); patients undergoing carotid endarterectomy; and patients undergoing abdominal aortic aneurysm (AAA) repair.

    

5. The Royal College of Surgeons of England is a professional membership organisation and registered charity, which exists to advance surgical standards and improve patient care.

    

6. For more information, please contact the RCS Press Office: telephone: 020 7869 6047/6052; email: pressoffice@rcseng.ac.uk ; out of hours media enquiries: 0207 869 6056.