A novel method represents the first human repair of malfunctioning mechanical heart valves without surgery.
It paves the way for new possibilities in interventional cardiology, offering better safety and a higher quality of life for thousands of patients.
A collaborative team from the Centro Nacional de Investigaciones Cardiovasculares (CNIC) and the Hospital Clínico Universitario de Valladolid has pioneered and clinically implemented a minimally invasive, catheter-based method.
For the first time, this approach enables the treatment of defective mechanical aortic valves without the risks associated with open-heart surgery.
The innovative procedure offers hope to patients previously limited by few treatment options, expanding the scope of available treatments.
Led by Dr Borja Ibáñez and Dr Alberto San Román, these research groups are part of Spain’s prominent CIBERCV cardiovascular research network.
Mechanical heart valves have been used for decades to treat severe aortic valve disease, and their high durability makes them particularly attractive for younger patients. However, when these prostheses fail, either due to obstruction of their mobile discs or other malfunctions, the only available treatment until now has been repeat open-heart surgery, a high-risk procedure that is not feasible for many patients.
Dr Ibáñez, CNIC Scientific Director, cardiologist at Hospital Universitario Fundación Jiménez Díaz, and senior author of the study published in the European Heart Journal, said: ‘We were encountering patients with severely dysfunctional mechanical valves for whom no reasonable therapeutic option existed. The risk of repeat surgery was prohibitive, and until now there were no effective percutaneous alternatives.’
Unlike biological valves, mechanical valves could not previously be treated with catheter-based techniques. The new study describes the first minimally invasive alternative for these complex cases. Specifically, the researchers developed and validated a strategy – mechanical valve-in-valve (ViMech) – that enables the catheter-mediated implantation of a new valve inside a defective mechanical valve after controlled removal of its mobile discs.
The study reports the first three ViMech transcatheter aortic valve implantation procedures in humans, performed in patients aged 67 to 79 who had undergone multiple previous cardiac surgeries or had severe mechanical valve-related complications that made conventional reoperation impossible. In all cases, the procedure immediately restored valve function, with a very favourable clinical course and no major neurological or vascular events during follow-up.
Dr San Román, Chief of Cardiology at Hospital Clínico de Valladolid, said: ‘In these first patients, the procedure was successfully performed through the femoral artery, avoiding open surgery. Once the mechanical discs were removed, a new transcatheter heart valve was implanted, restoring normal blood flow. All patients remained clinically stable during follow-up.’
In addition, Dr San Román noted that in some cases the procedure allowed significant simplification of the antithrombotic regimen, avoiding the lifelong anticoagulation usually required for mechanical valves. This has a direct impact on the safety and quality of life of very fragile patients.
At six-month follow-up, all patients were alive, asymptomatic, and functioning normally with their transcatheter prostheses, with no significant ischaemic or haemorrhagic events.
The authors note that the study has limitations, including the small number of treated patients and the need to further investigate the optimal antithrombotic strategy after this procedure.
Even so, the study represents the first complete demonstration – from laboratory development to patient application – that percutaneous treatment of defective mechanical valves is feasible.
The authors concluded that this strategy could transform the clinical management of thousands of patients in the future by offering a less aggressive option and significantly expanding therapeutic possibilities in interventional cardiology.
