Tamm Alexander R, Hell Michaela M, Geyer Martin, Kreidel Felix, da Rocha E Silva Jaqueline G, Seidl Meike, Ruf Tobias F, Kornberger Angela, Beiras-Fernandez Andres, Münzel Thomas, von Bardeleben Ralph Stephan
Center of Cardiology, University Medical Center Mainz, Mainz, Germany.
Department of Cardiac and Vascular Surgery, University Medical Center Mainz, Mainz, Germany.
Front Cardiovasc Med. 2021 Mar 18;8:623146. doi: 10.3389/fcvm.2021.623146. eCollection 2021.
We investigated performance and outcome of the latest-generation balloon-expandable SAPIEN 3 Ultra prosthesis (S3U) compared to the established SAPIEN 3 prosthesis (S3) in a real-world cohort, with focus on paravalvular regurgitation (PVR). PVR is an adverse prognostic indicator of short- and long-term survival after transcatheter aortic valve replacement (TAVR). The S3U has been designed to improve sealing. We enrolled 343 consecutive patients presenting with severe native aortic valve stenosis eligible for a balloon-expandable prosthesis. The established S3 was implanted in the first 200 patients, the following 143 patients received the novel S3U after introduction in our institution. Primary endpoint was PVR after TAVR. Furthermore, we investigated procedural parameters and in-hospital and 30-day outcome. PVR was significantly lower in the S3U cohort compared to the S3 cohort. They differed in their rate of mild PVR (11.2 vs. 48.0%, < 0.001), whereas at least moderate PVR was similarly low in both cohorts (0.7 vs. 0.5%, = 0.811). A significant reduction of post-dilatation rate, fluoroscopy time, and amount of contrast was observed in patients treated with the novel S3U ( < 0.001). The rate of adverse events in the in-hospital course and at 30 days were similarly low. At 30 days more patients receiving S3U improved in NYHA class (improvement ≥2 grades 34.6 vs. 19.9%, = 0.003). The current study provides evidence that the novel S3U strongly minimizes PVR, thereby demonstrating the efficacy of improved sealing. Further studies will have to address if the observed reduction of PVR with S3U has prognostic significance.
我们在一个真实世界队列中研究了最新一代球囊扩张式SAPIEN 3 Ultra人工瓣膜（S3U）与已确立的SAPIEN 3人工瓣膜（S3）相比的性能和结局，重点关注瓣周反流（PVR）。PVR是经导管主动脉瓣置换术（TAVR）后短期和长期生存的不良预后指标。S3U旨在改善密封性能。我们纳入了343例连续的重度原发性主动脉瓣狭窄且适合植入球囊扩张式人工瓣膜的患者。前200例患者植入已确立的S3，在S3引入我们机构后，接下来的143例患者接受了新型S3U。主要终点是TAVR后的PVR。此外，我们还研究了手术参数以及住院期间和30天的结局。与S3队列相比，S3U队列中的PVR显著更低。它们在轻度PVR发生率方面存在差异（11.2%对48.0%，P<0.001），而至少中度PVR在两个队列中同样较低（0.7%对0.5%，P = 0.811）。接受新型S3U治疗的患者在球囊后扩张率、透视时间和造影剂用量方面有显著降低（P<0.001）。住院期间和30天时不良事件发生率同样较低。在30天时，更多接受S3U的患者纽约心脏协会（NYHA）心功能分级得到改善（改善≥2级：34.6%对19.9%，P = 0.003）。当前研究提供了证据表明新型S3U能极大地减少PVR，从而证明了改善密封的有效性。如果观察到的S3U导致的PVR降低具有预后意义，还需要进一步研究。
