Title: PreSize Stenting: medical device software that allows pre-operative rehearsals of stenting surgeries to reduce complications
Funder: Department of Health and Social Care

Abstract: Stents are small spring-like metallic devices, which are used to treat blood vessel diseases. They can reinforce weak vessel walls, open up clogged passages, or divert blood flow to avoid rupture. More than fifty thousand stenting procedures are performed every year in the UK, and this number is rapidly growing. The shape and size of blood vessels varies a lot among people, as does the behaviour of stents of different makes. After a stent is placed, its length can change dramatically, depending on its flexibility and positioning. Without any tools to assist them, surgeons are left with a great degree of uncertainty in choosing a suitable device for a patient before the procedure. Stenting saves many lives, but one in every ten procedures still leads to dangerous complications, and one in every five requires a repeat surgery. We designed our software solution, PreSize Stenting, to tackle the uncertainty. Using an application on their computers, surgeons will load a patient s medical scan and virtually try out different stents for them. The tool uses the latest scientific advances to build a computer model of the patient s blood vessels and simulate the mechanics affecting the final length and position of the stent. Armed with this crucial information, the surgeons will be able to make the best decision for each patient. We have built the first version of the software. The next key step is verifying that it works reliably and consistently for different patients in different hospitals. In this project we will establish a formal agreement with three London hospitals to process a number of past cases (without any patient identifying information). We will design a scientific study to verify that the computer models we show surgeons accurately represent the reality. Finally, we will prepare for a follow-up clinical evaluation of the tool, where patients would be recruited and predicted outcomes would be compared with actual surgery results. Working closely with clinical staff and patients, we will make absolutely sure that our solution is safe and reliable, and helps surgeons achieve better outcomes in their practice. We are keen to involve patients who have experienced the disease and stent treatment first-hand, so that we may understand their perspective and how our research can address their needs. We will reach out to patient groups in the UK (Brain Aneurysm Awareness UK, Headway &ndash; Brain Injury Association, Brain Haemorrhage Support Group, Neurovascular Support Group, British Heart Foundation affiliated heart support groups, Essex Heart Beat, Hearts in Beds, Tickers Rehab) to find people who may be interested in advising us as members of a project patient advisory group.

Lay abstract: Stents are small spring-like metallic devices, which are used to treat blood vessel diseases. They can reinforce weak vessel walls, open up clogged passages, or divert blood flow to avoid rupture. More than fifty thousand stenting procedures are performed every year in the UK, and this number is rapidly growing. The shape and size of blood vessels varies a lot among people, as does the behaviour of stents of different makes. After a stent is placed, its length can change dramatically, depending on its flexibility and positioning. Without any tools to assist them, surgeons are left with a great degree of uncertainty in choosing a suitable device for a patient before the procedure. Stenting saves many lives, but one in every ten procedures still leads to dangerous complications, and one in every five requires a repeat surgery. We designed our software solution, PreSize Stenting, to tackle the uncertainty. Using an application on their computers, surgeons will load a patient s medical scan and virtually try out different stents for them. The tool uses the latest scientific advances to build a computer model of the patient s blood vessels and simulate the mechanics affecting the final length and position of the stent. Armed with this crucial information, the surgeons will be able to make the best decision for each patient. We have built the first version of the software. The next key step is verifying that it works reliably and consistently for different patients in different hospitals. In this project we will establish a formal agreement with three London hospitals to process a number of past cases (without any patient identifying information). We will design a scientific study to verify that the computer models we show surgeons accurately represent the reality. Finally, we will prepare for a follow-up clinical evaluation of the tool, where patients would be recruited and predicted outcomes would be compared with actual surgery results. Working closely with clinical staff and patients, we will make absolutely sure that our solution is safe and reliable, and helps surgeons achieve better outcomes in their practice. We are keen to involve patients who have experienced the disease and stent treatment first-hand, so that we may understand their perspective and how our research can address their needs. We will reach out to patient groups in the UK (Brain Aneurysm Awareness UK, Headway &ndash; Brain Injury Association, Brain Haemorrhage Support Group, Neurovascular Support Group, British Heart Foundation affiliated heart support groups, Essex Heart Beat, Hearts in Beds, Tickers Rehab) to find people who may be interested in advising us as members of a project patient advisory group.

Research activity codes: 6.4 SURGERY;5.4 SURGERY
Health categories: CARDIOVASCULAR