Department of Cardiology, Cardiovascular Center Bad Neustadt, Bad Neustadt a. d. Saale, Germany.
EuroIntervention. 2017 May 15;13(1):53-59. doi: 10.4244/EIJ-D-16-00898.
Long-term outcomes are available for first-generation transcatheter heart valves but data on second-generation devices are scarce. We aimed to provide an oversight of all patients implanted with a second-generation valve in our centre.
From April 2012 to July 2016, 219 patients were enrolled in this prospective single-centre experience; they received either the transapical ACURATE TA (n=99) or the transfemoral ACURATE neo (n=120) prosthesis. Data were collected during the hospital stay and telephone follow-ups were conducted at 30 days post procedure and annually thereafter. Patients were 80.9±4.4 years old with a mean logistic EuroSCORE I of 19.3±13.9%. Transapical patients had significantly more comorbidities at baseline. Post intervention, mean gradient was reduced to 10.6±9.2 mmHg, and 1.9% had moderate paravalvular regurgitation. Mean follow-up time, based on the last patient contact, was 217±188 days for the transfemoral and 525±413 days for the transapical group. Thirty-day mortality was 2.5% and 4.0%, and one-year Kaplan-Meier survival was 94.8% (95% CI: 87.5-97.9) and 81.9% (95% CI: 72.0-88.5), respectively. At two years, survival was 64.9% (95% CI: 52.6-74.7) for transapical patients.
This early single-centre experience showed very good safety and performance outcomes in patients treated with the ACURATE prostheses.
第一代经导管心脏瓣膜的长期疗效数据已有报道,但第二代器械的数据却很少。我们旨在提供在我们中心植入第二代瓣膜的所有患者的综合数据。
2012 年 4 月至 2016 年 7 月,前瞻性单中心经验纳入 219 例患者;他们接受了经心尖植入的 ACURATE TA(n=99)或经股动脉植入的 ACURATE neo(n=120)瓣膜。数据在住院期间收集,术后 30 天和此后每年进行电话随访。患者年龄 80.9±4.4 岁,平均 logistic EuroSCORE I 为 19.3±13.9%。经心尖组患者的基线合并症更多。介入治疗后,平均梯度降低至 10.6±9.2mmHg,1.9%患者出现中度瓣周漏。基于最后一次患者接触,经股动脉组和经心尖组的平均随访时间分别为 217±188 天和 525±413 天。30 天死亡率分别为 2.5%和 4.0%,1 年 Kaplan-Meier 生存率分别为 94.8%(95%CI:87.5-97.9)和 81.9%(95%CI:72.0-88.5)。两年时,经心尖组的生存率为 64.9%(95%CI:52.6-74.7)。
这项早期的单中心经验显示,ACURATE 瓣膜治疗的患者具有非常好的安全性和疗效。