Outcomes of Self-Expanding Transcatheter Pulmonary Valves:Extended Follow-Up of a Prospective Trial

摘要

Background:The Venus-P valve was the first self-expanding valve used world-wide for transcatheter pulmonary valve replacement(TPVR)in patients with severe pulmonary regurgitation(PR).We intended to report the extended follow-up results from the prospective trial(No.NCT02590679).Methods:A total of 38 patients with severe PR(mean age 24.2±13.2)were included.Follow-up data were obtained after implanted at 1,6,and 12 months and yearly after.The frame geometry was assessed on post-implant computer tomography(CT)scanning by calculating the non-circularity[circularity ratio(minimum diameter/maximum diameter)<0.9]and under-expansion[expansion ratio(derived external valve area/nominal external valve area)<0.9).Adverse events(all-cause mortality,reintervention,valve dysfunction,stent fracture and endocarditis)were recorded.Results:All valves were implanted successfully with normal function at discharge.Geometric CT analysis showed underexpanded valve was detected in 22 patients(63%)and non-circular valve was seen in 16 patients(46%).During a median follow-up of 4.8 years(range 0.3-8.1),there were 1 death and 1 surgical explant,both resulting from endocarditis.Five-year freedom from valve dysfunction and stent fracture were 84.8%(95%CI 74.8-94.7)and 83.5%(95%CI 73.8-93.2).Endocarditis occurred in 3 patients at a median time of 7 months.Stent fracture was more common in patients with non-circularity stents.Conclusion:TPVR using Venus-P valve is associated with favorable outcomes at 5 years.Non-circular shapes in the valve level may have a higher risk of stent fracture.