Department of Cardiology, Clinical Sciences, Lund University, Skane University Hospital, 221-85, Lund, SE, Sweden.
BMC Cardiovasc Disord. 2019 Feb 26;19(1):44. doi: 10.1186/s12872-019-1021-7.
The mechanically expandable Lotus Valve System is a fully repositionable and retrievable valve with an adaptive seal to minimize paravalvular leak (PVL). The aim of this study was to evaluate the short- and long-term safety and efficacy of the new device with focus on a new implantation technique to reduce the need for a permanent pacemaker (PPM) post procedure.
We performed a prospective single-center, non-randomized evaluation of the Lotus Valve System. The first 100 consecutive Lotus Valve implantations were included in the analysis. Outcome was assessed according to VARC2-criteria. Postoperative pacemaker rates were assessed using the national pacemaker registry and electronic medical records. Mortality at 30 days and 12 months were acquired from the national population registry.
Mean age was 82.7 ± 5.6 years, mean Euroscore I was 25.3 ± 14.5%, mean STS-score was 6.5 ± 4.1% and mean aortic valve area was 0.6 ± 0.1 cm. There were no cases of valve embolization, ectopic valve deployment or additional valve implantation. Device success according to the VARC2-criteria was 97%. The 30-day mortality rate was 3%. Two deaths occurred due to stroke and one due to a ventricular rupture. Major stroke rate was 2% and major vascular complication rate was 2%. The 12-month mortality rate was 14%. At discharge 87% of patients had no/trace PVL, 12% had mild PVL and one patient had a moderate PVL. A total of 13% received a new PPM post valve implantation. Among patients who did not have a PPM before the procedure, the PPM rate was 15.3%.
This single-center evaluation of the Lotus Valve System demonstrated a good clinical outcome with a low mortality, in a high-risk population. Introduction of a new implantation technique resulted in lower PPM rates than previously reported without negatively affecting PVL.
Current Controlled Trials ISRCTN14952278 , retrospectively registered 06/11/2017.
机械可扩张的 Lotus 瓣膜系统是一种完全可重新定位和可回收的瓣膜，具有自适应密封功能，可最大程度减少瓣周漏（PVL）。本研究的目的是评估该新型装置的短期和长期安全性和疗效，并重点关注一种新的植入技术，以减少术后永久性起搏器（PPM）的需求。
我们进行了前瞻性的单中心、非随机 Lotus 瓣膜系统评估。将前 100 例连续的 Lotus 瓣膜植入纳入分析。根据 VARC2 标准评估结果。使用国家起搏器登记处和电子病历评估术后起搏器植入率。通过国家人口登记处获得 30 天和 12 个月的死亡率。
平均年龄为 82.7±5.6 岁，平均 Euroscore I 为 25.3±14.5%，平均 STS 评分 6.5±4.1%，平均主动脉瓣口面积为 0.6±0.1cm。无瓣膜栓塞、异位瓣膜展开或额外瓣膜植入的情况。根据 VARC2 标准，器械成功率为 97%。30 天死亡率为 3%。两例死亡归因于中风，一例归因于心室破裂。主要中风发生率为 2%，主要血管并发症发生率为 2%。12 个月死亡率为 14%。出院时，87%的患者无/微量瓣周漏，12%的患者有轻度瓣周漏，1 例患者有中度瓣周漏。共有 13%的患者在瓣膜植入后需要新的 PPM。在术前未植入 PPM 的患者中，PPM 发生率为 15.3%。
该 Lotus 瓣膜系统的单中心评估显示，在高危人群中具有良好的临床结局，死亡率低。采用新的植入技术可降低 PPM 发生率，且不会对瓣周漏产生负面影响。
当前对照试验 ISRCTN8561422，于 2017 年 6 月 11 日进行了回顾性注册。
