Pilgrim Thomas, Lee Joe K T, O'Sullivan Crochan J, Stortecky Stefan, Ariotti Sara, Franzone Anna, Lanz Jonas, Heg Dik, Asami Masahiko, Praz Fabien, Siontis George C M, Vollenbroich René, Räber Lorenz, Valgimigli Marco, Roost Eva, Windecker Stephan
Department of Cardiology, University of Bern, Bern, Switzerland.
Triemlispital, Zurich, Switzerland.
Open Heart. 2018 Jan 20;5(1):e000695. doi: 10.1136/openhrt-2017-000695. eCollection 2018.
Contemporary data comparing early versus newer generation transcatheter heart valve (THV) devices in routine clinical practice are lacking. We sought to compare the safety and efficacy of early versus newer generation THVs in unselected patients undergoing transcatheter aortic valve implantation (TAVI).
We performed a propensity score matched analysis of patients undergoing transfemoral TAVI at a single centre with early versus newer generation devices between 2007 and 2016. Patients were matched for balloon-expandable versus self-expandable valves and Society of Thoracic Surgeons score. The primary end point was the Valve Academic Research Consortium (VARC)-2 early safety composite end point at 30 days. Among the 391 matched pairs, no differences between early (21.2%) and newer generation (20.8%) THVs regarding the early safety composite end point (HR 0.98, 95% CI 0.72 to 1.33, P=0.88) were observed. The rates of valve embolisation (0.8% vs 4.2%, P=0.005), bleeding events (24.8% vs 32.0%, P=0.028) and moderate-to-severe paravalvular regurgitation (PVR) (3.1% vs 12.1%, P<0.001) were lower among patients receiving newer generation devices. Conversely, patients treated with early generation THVs less frequently experienced annulus rupture (0% vs 2.0%, P=0.008).
Newer compared with early generation THV devices were associated with a lower rate of valve embolisation, PVR and bleeding events.
缺乏在常规临床实践中比较早期与新一代经导管心脏瓣膜(THV)装置的当代数据。我们试图比较在接受经导管主动脉瓣植入术(TAVI)的未选择患者中,早期与新一代THV的安全性和有效性。
我们对2007年至2016年间在单一中心接受经股动脉TAVI的患者进行了倾向评分匹配分析,比较使用早期与新一代装置的情况。患者在球囊扩张式瓣膜与自膨胀式瓣膜以及胸外科医师协会评分方面进行匹配。主要终点是30天时的瓣膜学术研究联盟(VARC)-2早期安全性复合终点。在391对匹配病例中,未观察到早期(21.2%)与新一代(20.8%)THV在早期安全性复合终点方面存在差异(风险比0.98,95%置信区间0.72至1.33,P=0.88)。接受新一代装置的患者中,瓣膜栓塞率(0.8%对4.2%,P=0.005)、出血事件发生率(24.8%对32.0%,P=0.028)和中重度瓣周反流(PVR)(3.1%对12.1%,P<0.001)较低。相反,接受早期THV治疗的患者较少发生瓣环破裂(0%对2.0%,P=0.008)。
与早期THV装置相比,新一代THV装置与较低的瓣膜栓塞率、PVR和出血事件发生率相关。