Posted on Wednesday 22 December 2021
Clive Robinson with his heart stent
Heart specialists at Guy’s and St Thomas’ were the first in the UK to have developed a new technique for people with a complex hole in the heart.
The innovative method has so far benefited more than three dozen people, enabling them to avoid open heart surgery and to recover more quickly.
The technique is used for patients who have the congenital heart condition sinus venosus atrial septal defect (SVASD) and partial anomalous pulmonary venous drainage (PAPVD).
This causes breathlessness and palpitations which can lead to an irregular heartbeat (atrial fibrillation) and life-threatening clots in the heart. Previously, the only treatment available was open heart surgery.
Currently, up to 70 adults in the UK undergo open heart surgery for this defect each year.
Guy’s and St Thomas’ is the largest centre worldwide undertaking this procedure with custom-made stents, and the only unit in the UK doing it this way.
The first patient to be helped in the UK was Clive Robinson, 66, who was diagnosed with the heart defect. With open heart surgery his only conventional option, Clive was referred to Guy’s and St Thomas’ where he met Professor Eric Rosenthal, consultant paediatric and adult congenital cardiologist at Evelina London Children’s Hospital.
Prof Rosenthal then spent two years developing and getting approval for a technique using a specially made covered stent, which had only been used once before in India. For the first time in the UK, the four-hour procedure was carried out on Clive in March 2016.
Since then, Clive has had annual checks which have shown his heart to be in good shape, enabling him to enjoy an active life.
Clive said: “Before I met Eric, I was facing open heart surgery with all that entails plus months of rest and recuperation. This meant no driving and certainly no golf for many months.
“With Eric’s new method I was in hospital for a few nights to allow the incision to start to heal and had no pain. Within a very short time there was a marked improvement in my energy and strength and I was sleeping better.”
Clive, from Ashtead in Surrey, added: “Now I feel great. I noticed an improvement in fitness within a week. I was driving within two weeks and swinging a golf club within a month. Within a short period of time I felt a surge of energy and was stronger, fitter and was sleeping better. It’s amazing.”
The pioneering procedure with Clive has enabled around 40 people to also benefit from having the custom-made stent fitted.
How the procedure works
The conditions SVASD and PAPVD is where a hole allows blood from the left atrium to flow into the right atrium. The right pulmonary veins also drain into the right atrium rather than the left atrium, further increasing the volume of abnormal blood flow.
Less complex holes in the heart are routinely closed using a plug device after passing it up to the heart from the main femoral vein in the leg. But with this type of hole in the heart, a plug can’t be held in place because there isn’t enough tissue for the plug to grip onto.
Cardiologists at Guy’s and St Thomas’ are now using a specially designed tube-shaped device – a covered stent that is custom-made for the patient - to divert the abnormal pulmonary veins from the right atrium to the left atrium while at the same time using the covered stent itself to close the hole. This corrects two defects with one device.
The procedure was made possible by a 3D print out of Clive’s heart through the support of Guy’s & St Thomas’ Charity, which enables projects to improve patient experience and staff welfare through generous public donations.
Prof Rosenthal said: “We used a 3D printer to create a heart model and this helped confirm that by inserting a stent into the heart from a leg vein it would correct Clive’s condition.
“We had read the report from the procedure in India but were uncertain that it could work as this was a revolutionary approach and it was difficult to get a grasp on it. We normally look at X-rays, scans and other 2D images but it was only after printing the heart in 3D that the penny really dropped.”
The nickel-titanium covered stent, around 6 cm long and which can expand to 3.5 cm wide, was inserted through a small incision in Clive’s groin, up into his heart to close the hole and simultaneously divert the pulmonary veins into the left atrium.
Because the balloon-mounted covered stent was larger than that licensed anywhere in the world, approval had to be gained from the Medicines and Healthcare products Regulatory Agency (MHRA).
Prof Rosenthal said: “We were extremely happy with the outcome – as was Clive – and we began to offer it to more patients with the condition. Around three out of four patients with the condition are suitable and we have now successfully completed the stent procedure on around 40 people.”
Techniques that formed the basis of this procedure were originally developed in children at Evelina London, part of Guy’s and St Thomas’, for other conditions.
Although up to eight in every 1,000 babies are born with congenital heart disease, this particular type of septal defect or hole in the heart remains rare. This procedure is suitable for some adults and fully grown older children but younger children still require open heart surgery.
The MHRA has allowed the specialist team to continue using these particular stents without requesting permission for each patient but restricting the procedure to Guy’s and St Thomas’ until sufficient data is available.
The intervention will be expanded to other UK heart centres when the MHRA considers a sufficient number of patients have undergone the procedure. Prof Rosenthal is also working with other centres internationally to help set up their programmes.