Neochord DS1000系统与传统二尖瓣修复术对后小叶脱垂导致的二尖瓣返流的矫正

IF 1.6 4区 医学 Q3 CARDIAC & CARDIOVASCULAR SYSTEMS Interactive cardiovascular and thoracic surgery Pub Date : 2022-05-27 DOI:10.1093/icvts/ivac139
T. David
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They identified 88 pairs of patients with similar clinical profiles except for functional class which was worse in the Neochord group. The patients in this study were younger than in most reports on longitudinal outcomes of mitral valve repair [2, 3]. The chose patients’ survival as the primary endpoint of the study but since a propensity score analysis was used to compensate for differences in age and comorbidities, this does not seem rational. The secondary endpoints of reoperation on the mitral valve and freedom from moderate or severe MR are far more pertinent in this type of comparing procedures to treat MR. Before discharge from hospital, 8 patients in the Neochord and 1 patient in the surgical repair group had moderate or severe MR. The 5-year survival was similar, as one would expect, but the freedom from recurrent MR was only 57.6% in the Neochord group and 84.6% in the surgical repair group, and the freedom from reoperation was 78.9% in the first group and 92% in the second. Neochord DS1100 gained European market approval in 2016 and FDA approval for a randomized clinical trial in the USA in the same year [4]. I have not been able to find any publication on that randomized trial, likely because it is still enrolling patients in spite of the fact that 6 years have passed since its FDA approval [4]. Hopefully, this randomized clinical trial will help us to determine the usefulness of this device. Based on D’Onofrio and colleagues [1] experience and on that of others [3], I am not sure this device should be used in any patient who can have conventional mitral valve repair. There are, however, patients with posterior leaflet prolapse with intractable heart failure that would not tolerate a median sternotomy or even a right mini-thoracotomy with cardiopulmonary bypass and, perhaps, they should be considered for this device but only after excluding the feasibility of a transcatheter Mitraclip (Abbott Laboratories, Chicago, IL, USA), which is likely to provide better and safer outcomes [5]. I have been practicing cardiac surgery for over 4 decades and prospectively followed certain groups of my patients. Mitral valve surgery is one of them, and I have over 3000 mitral valve repairs in my database of prospectively followed patients. There are few cardiac procedures that restore lifespan and quality of life as well as mitral valve repair for MR due to leaflet prolapse. 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引用次数: 1

摘要

在这一期的《互动心血管与胸外科》杂志上,帕多瓦大学的D 'Onofrio及其同事[1]比较了Neochord DS1100 (Neochord, Inc.)矫正后小叶脱垂导致的二尖瓣反流(MR)的围手术期和5年结果。St. Louis Park, MN, USA)与传统二尖瓣修复。2010年至2018年招募了患者,排除后,作者有281名患者可用于研究:169名患者接受了Neochord, 112名患者接受了手术修复,这表明作者倾向于使用Neochord治疗后小叶脱垂。为了弥补手术选择的差异,作者使用倾向评分分析,使用术前临床变量被认为会影响结果。他们确定了88对具有相似临床特征的患者,除了Neochord组的功能分类更差。本研究的患者比大多数二尖瓣修复纵向结果报道的患者更年轻[2,3]。选择患者的生存作为研究的主要终点,但由于使用倾向评分分析来补偿年龄和合并症的差异,这似乎是不合理的。在这类治疗MR的比较方法中,二尖瓣再手术和无中度或重度MR的次要终点更为相关。出院前,Neochord组和外科修复组分别有8例和1例患者有中度或重度MR。正如人们所预料的,5年生存率相似,但Neochord组和外科修复组的MR复发率仅为57.6%和84.6%。第一组和第二组的再手术成功率分别为78.9%和92%。Neochord DS1100于2016年获得欧洲市场批准,同年在美国获得FDA的随机临床试验批准[4]。我还没有找到任何关于该随机试验的出版物,可能是因为尽管自FDA批准以来已经过去了6年[4],但该试验仍在招募患者。希望这个随机临床试验能帮助我们确定这个装置的有用性。根据D 'Onofrio等人[1]和其他人[3]的经验,我不确定这种装置是否应该用于任何可以进行常规二尖瓣修复的患者。然而,有一些后小叶脱垂合并顽固性心力衰竭的患者不能忍受正中胸骨切开术甚至右小胸切开术联合体外循环,也许他们应该考虑使用这种装置,但必须排除经导管Mitraclip (Abbott Laboratories, Chicago, IL, USA)的可行性,后者可能提供更好、更安全的结果[5]。我从事心脏外科手术已有40多年,并对我的某些患者群体进行了前瞻性随访。二尖瓣手术就是其中之一,我的数据库中有超过3000个二尖瓣修复的患者。很少有心脏手术可以恢复寿命和生活质量,以及修复由于小叶脱垂的MR的二尖瓣。在过去的2000年的修复中,我没有失去一个病人,在我们单位最近的一份报告中[2],20年的再手术累计发生率为4.6%,复发的中度或重度MR累计发生率为12.5%。现有的技术(如NeoChord或Mitraclip)很难提供类似的结果。
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Neochord DS1000 system versus conventional mitral valve repair for correction of mitral regurgitation due to prolapse of the posterior leaflet
In this issue of the Interactive CardioVascular and Thoracic Surgery, D’Onofrio and colleagues [1] from the University of Padua compared the perioperative and 5-year outcomes of correction of mitral regurgitation (MR) due to posterior leaflet prolapse with Neochord DS1100 (NeoChord, Inc. St. Louis Park, MN, USA) versus conventional mitral valve repair. Patients were enrolled from 2010 to 2018 and after exclusions, the authors had 281 patients available for the study: 169 had Neochord and 112 had surgical repair, suggesting the authors’ preference for Neochord to treat posterior leaflet prolapse. To compensate for discrepancies procedure selection, the authors used a propensity score analysis using preoperative clinical variables believed to affect outcome. They identified 88 pairs of patients with similar clinical profiles except for functional class which was worse in the Neochord group. The patients in this study were younger than in most reports on longitudinal outcomes of mitral valve repair [2, 3]. The chose patients’ survival as the primary endpoint of the study but since a propensity score analysis was used to compensate for differences in age and comorbidities, this does not seem rational. The secondary endpoints of reoperation on the mitral valve and freedom from moderate or severe MR are far more pertinent in this type of comparing procedures to treat MR. Before discharge from hospital, 8 patients in the Neochord and 1 patient in the surgical repair group had moderate or severe MR. The 5-year survival was similar, as one would expect, but the freedom from recurrent MR was only 57.6% in the Neochord group and 84.6% in the surgical repair group, and the freedom from reoperation was 78.9% in the first group and 92% in the second. Neochord DS1100 gained European market approval in 2016 and FDA approval for a randomized clinical trial in the USA in the same year [4]. I have not been able to find any publication on that randomized trial, likely because it is still enrolling patients in spite of the fact that 6 years have passed since its FDA approval [4]. Hopefully, this randomized clinical trial will help us to determine the usefulness of this device. Based on D’Onofrio and colleagues [1] experience and on that of others [3], I am not sure this device should be used in any patient who can have conventional mitral valve repair. There are, however, patients with posterior leaflet prolapse with intractable heart failure that would not tolerate a median sternotomy or even a right mini-thoracotomy with cardiopulmonary bypass and, perhaps, they should be considered for this device but only after excluding the feasibility of a transcatheter Mitraclip (Abbott Laboratories, Chicago, IL, USA), which is likely to provide better and safer outcomes [5]. I have been practicing cardiac surgery for over 4 decades and prospectively followed certain groups of my patients. Mitral valve surgery is one of them, and I have over 3000 mitral valve repairs in my database of prospectively followed patients. There are few cardiac procedures that restore lifespan and quality of life as well as mitral valve repair for MR due to leaflet prolapse. I have not lost a single patient during the past 2000 repairs, and in a recent report from out unit [2] the cumulative incidence of reoperation was 4.6% and the cumulative incidence of recurrent moderate or severe MR was 12.5% at 20 years. It would be very difficult for existing available technologies such as NeoChord or Mitraclip to provide similar outcomes.
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来源期刊
Interactive cardiovascular and thoracic surgery
Interactive cardiovascular and thoracic surgery CARDIAC & CARDIOVASCULAR SYSTEMS-
CiteScore
3.30
自引率
0.00%
发文量
292
审稿时长
2-4 weeks
期刊介绍: Interactive CardioVascular and Thoracic Surgery (ICVTS) publishes scientific contributions in the field of cardiovascular and thoracic surgery, covering all aspects of surgery of the heart, vessels and the chest. The journal publishes a range of article types including: Best Evidence Topics; Brief Communications; Case Reports; Original Articles; State-of-the-Art; Work in Progress Report.
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