First-in-human implantation of a customised balloon-expandable valve into a dysfunctional Tendyne valve

During the 4-year follow-up of a patient with a Tendyne valve (Abbott) implanted in 2019, the transthoracic echocardiogram (TTE) showed valve dysfunction with severe mitral regurgitation (MR). Transoesophageal echocardiography (TOE) displayed multiple jets at the level of the outer frame, normal leaflet excursion, and no endocarditic foci. On a cardiac computed tomography (CT) scan, the Tendyne valve showed no structural anomalies and appeared normopositioned (Supplementary Figure 1, Supplementary Figure 2, Moving image 1).

Surgical intervention was excluded because of an extremely high operative risk, but even the transcatheter approach was challenging. A two-step strategy, involving the implantation of a covered stent followed by a SAPIEN 3 (S3 [Edwards Lifesciences]), would have led to a prolonged period of massive MR and haemodynamic instability. The implant of a standard S3 alone would have maintained a more stable positioning, but its upper free-flow segment would not permit leak closure. To overcome this issue, we decided to perform a direct valve-in-valve (ViV) procedure with a customised S3 (Figure 1), sewing a polytetrafluoroethylene (PTFE) patch to cover the...