Third-Generation Transcatheter Aortic Heart Valve with Reverse Parachute Sealing Cuff in Patients with Aortic Valve Disease

BackgroundThe Navitor (Abbott Inc, IL, USA) transcatheter heart valve is a novel third-generation self-expanding bioprosthesis with specific features to mitigate paravalvular regurgitation (PVR). Owing to its novelty, there is a paucity of data on its application in clinical practice.MethodsConsecutive cohort analysis of the use of the Navitor system in an as-treated clinical setting at a quaternary heart hospital.ResultsSixty consecutive non-clinical trial patients treated with Navitor were identified. All patients underwent a successful procedure. The mean age was 79.3 years (±SD 7.82), 56.67% (n=34) were female, and the mean STS score was 4.87 (±SD 5.70). At 30 days post-procedure, all patients were alive with no readmissions for heart failure. One patient had a major vascular complication (1.7%). Four patients (7.14% of patients without a pre-existing pacemaker) received a new permanent pacemaker. Two patients (3.4%) had a non-disabling stroke. PVR at 30 days was trivial or none in 75% of patients, and no patient had worse than mild PVR.ConclusionsThe Navitor system in this as-treated cohort was associated with favourable clinical, haemodynamic, and safety outcomes. The Navitor (Abbott Inc, IL, USA) transcatheter heart valve is a novel third-generation self-expanding bioprosthesis with specific features to mitigate paravalvular regurgitation (PVR). Owing to its novelty, there is a paucity of data on its application in clinical practice. Consecutive cohort analysis of the use of the Navitor system in an as-treated clinical setting at a quaternary heart hospital. Sixty consecutive non-clinical trial patients treated with Navitor were identified. All patients underwent a successful procedure. The mean age was 79.3 years (±SD 7.82), 56.67% (n=34) were female, and the mean STS score was 4.87 (±SD 5.70). At 30 days post-procedure, all patients were alive with no readmissions for heart failure. One patient had a major vascular complication (1.7%). Four patients (7.14% of patients without a pre-existing pacemaker) received a new permanent pacemaker. Two patients (3.4%) had a non-disabling stroke. PVR at 30 days was trivial or none in 75% of patients, and no patient had worse than mild PVR. The Navitor system in this as-treated cohort was associated with favourable clinical, haemodynamic, and safety outcomes.