Circulation Journal Official Journal of the Japanese Circulation Society http://www. j-circ.or.jp fraction of 50.8%, a significantly enlarged RV (RV end-diastolic volume index of 160 ml/m 2 ) with depressed contractility, and RV ejection fraction of 30%. Accordingly, we decided to perform PVR with a recommendation of a fresh decellularized pulmonary allograft for the following reasons: (1) the relatively young age of the patient meant he might otherwise require multiple PVR in his lifetime if he received a commercially available biological valve; (2) long term anticoagulation therapy after PVR was not required; and (3) absence of pulmonary hypertension. He agreed to our recommendation, and we received approval from the Ethical Committee at Osaka University to use this approach.The fresh pulmonary allograft was provided by the German Society for Tissue Transplantation (Hannover, Germany) and decellularized by CorLife GbH (Hannover, Germany) (Figure 1). This decellularized human pulmonary valve (ESPOIR pulmonary valve) has been approved in Germany (approval no.: PEI.G.11634.01.1) for heart valve replacement since 2013, and ESPOIR pulmonary valves are currently being used in an investigative trial (NCT 02035540, ClinicalTrials. gov) in Europe. The operation was performed using re-median sternotomy, aortic and bicaval cannulation, and normothermic ulmonary valve regurgitation (PR) is the most common clinically important complication, typically occurring about 10 years after tetralogy of Fallot (TOF) repair. PR causes right ventricular (RV) enlargement as well as other complications, such as left ventricular dysfunction, arrhythmias, heart failure, and death. 1-3 Pulmonary valve replacement (PVR) is recommended before the occurrence of RV dysfunction, but the timing is still controversial because biological valves and cryopreserved homografts have relatively short durability with some late disadvantages, especially in adolescents. 4,5 Herein, we report the first clinical application of a decellularized fresh pulmonary allograft for PVR in Japan.The patient was a 35-year-old man diagnosed with TOF at birth. He underwent TOF repair using a mono-cusped transannular patch with mini-right ventriculotomy (Method III) 6 at 2 years of age in Osaka University Hospital. The postoperative course was uneventful for a few decades, but PR gradually progressed, and RV enlargement was recognizable. The ECG showed normal sinus rhythm, with QRS duration of 160 ms. Echocardiography showed RV enlargement, moderate to severe PR, and trivial tricuspid valve regurgitation. Cardiac magnetic resonance imaging showed a pulmonary valve regurgitant
Methods and Results:A fresh decellularized pulmonary allograft was used for PVR to correct pulmonary valve regurgitation in a 35-year-old man 33 years following tetralogy of Fallot repair. The postoperative course and shortterm valve function were excellent. This is the first case of a decellularized pulmonary allograft in Japan. therefore, there is a strong need for new-concept valves with markedly...