Buellesfeld Lutz, Gerckens Ulrich, Grube Eberhard
Department of Cardiology, HELIOS Heart Center Siegburg, Siegburg, Germany.
Catheter Cardiovasc Interv. 2008 Apr 1;71(5):579-84. doi: 10.1002/ccd.21470.
Percutaneous aortic valve replacement is a new less-invasive alternative for high-risk surgical candidates with aortic stenosis. However, the clinical experience is still limited, and the currently available 'first-generation devices' revealed technical shortcomings, such as lack of repositionability and presence of paravalvular leakages. We report the first-in-man experience with the new self-expanding Lotus Valve prosthesis composed of a nitinol frame with implemented bovine pericardial leaflets which is designed to address these issues, being repositionable and covered by a flexible membrane to seal paravalvular gaps. We implanted this prosthesis in a 93-year old patient presenting with severe symptomatic aortic stenosis (valve area: 0.6 cm(2)). Surgical valve replacement had been declined due to comorbidities.
We used a retrograde approach for insertion of the 21-French Lotus catheter loaded with the valve prosthesis via surgical cut-down to the external iliac artery. Positioning of the valve was guided by transesophageal echo and supra-aortic angiograms. The prosthesis was successfully inserted and deployed within the calcified native valve. Echocardiography immediately after device deployment showed a significant reduction of the transaortic mean pressure gradient (32 to 9 mmHg; final valve area 1.7 cm(2)) without evidence of residual aortic regurgitation. The postprocedural clinical status improved from NYHA-IV to NYHA-II. These results remained unchanged up to the 3 month follow-up.
Successful percutaneous aortic valve replacement can be performed using the new self-expanding and repositionable Lotus valve for treatment of high-risk patients with aortic valve stenosis. Further studies are mandatory to assess device safety and efficacy in larger patient populations.
经皮主动脉瓣置换术是高危主动脉瓣狭窄手术候选患者的一种新的微创替代方法。然而，临床经验仍然有限，目前可用的“第一代装置”存在技术缺陷，如缺乏可重新定位性和瓣周漏。我们报告了首例使用新型自膨胀Lotus瓣膜假体的人体经验，该假体由带有牛心包瓣叶的镍钛诺框架组成，旨在解决这些问题，具有可重新定位性，并由柔性膜覆盖以密封瓣周间隙。我们将此假体植入一名93岁患有严重症状性主动脉瓣狭窄（瓣口面积：0.6 cm²）的患者体内。由于合并症，患者拒绝接受外科瓣膜置换术。
我们采用逆行途径，通过手术切开至髂外动脉，插入装载瓣膜假体的21-French Lotus导管。瓣膜的定位由经食管超声心动图和主动脉弓造影引导。假体成功插入并部署在钙化的天然瓣膜内。装置部署后立即进行的超声心动图显示，跨主动脉平均压力梯度显著降低（从32 mmHg降至9 mmHg；最终瓣口面积1.7 cm²），且无残余主动脉瓣反流迹象。术后临床状态从纽约心脏协会（NYHA）IV级改善至NYHA II级。直至3个月随访时，这些结果保持不变。
使用新型自膨胀且可重新定位的Lotus瓣膜可成功进行经皮主动脉瓣置换术，用于治疗高危主动脉瓣狭窄患者。必须开展进一步研究以评估该装置在更大患者群体中的安全性和有效性。
