游离主动脉瓣环置换术与同种异体主动脉瓣环置换术的远期结果：前瞻性随机试验结果。

Late outcomes following freestyle versus homograft aortic root replacement: results from a prospective randomized trial.

机构信息

Department of Cardiac Surgery, Harefield and Royal Brompton NHS Trust, National Heart and Lung Institute, Imperial College London, London, United Kingdom.

出版信息

J Am Coll Cardiol. 2010 Jan 26;55(4):368-76. doi: 10.1016/j.jacc.2009.09.030.

DOI:10.1016/j.jacc.2009.09.030

PMID:20117443

Abstract

OBJECTIVES

The aims of this study were to compare long-term results after homograft versus Freestyle (Medtronic Inc., Minneapolis, Minnesota) aortic root replacement.

BACKGROUND

The ideal substitute for aortic root replacement remains undetermined.

METHODS

Between 1997 and 2005, 166 patients (age 65 +/- 8 years) undergoing total aortic root replacement were randomized to receive a homograft (n = 76) or a Freestyle bioprosthesis (n = 90). Six patients randomly assigned to homograft crossed over to Freestyle because of unavailability of suitably sized homografts. Median follow-up was 7.6 years (maximum 11 years; 1,035 patient-years). "Evolving" aortic valve dysfunction was defined as aortic regurgitation >/=2/4 and/or peak gradient >20 mm Hg.

RESULTS

Patient characteristics were comparable between groups. Concomitant procedures were performed in 44% and 47% of Freestyle and homograft patients, respectively (p = 0.5). Overall hospital mortality was 4.8% (1% for isolated root replacement). Eight-year survival was 80 +/- 5% in the Freestyle group versus 77 +/- 6% in the homograft group (p = 0.9). Freedom from need for reoperation at 8 years was significantly higher after Freestyle root replacement (100 +/- 0% vs. 90 +/- 5% after homograft replacement; p = 0.02). All reoperations were secondary to structural valve deterioration (n = 6). At last echocardiographic follow-up, actuarial freedom from evolving aortic valve dysfunction was 86 +/- 5% for Freestyle bioprostheses versus 37 +/- 7% for homografts (p < 0.001). Clinically, freedom from New York Heart Association functional class III to IV and freedom from valve-related complications were similar between groups (p = 0.7 and p = 0.9, respectively).

CONCLUSIONS

In this patient group, late survival is similar after homograft versus Freestyle root replacement. However, Freestyle aortic root replacement is associated with significantly less progressive aortic valve dysfunction and a lower need for reoperations.

摘要

目的

本研究旨在比较同种异体移植物与 Freestyle（美敦力公司，明尼苏达州明尼阿波利斯市）主动脉根部置换的长期结果。

背景

主动脉根部置换的理想替代物仍未确定。

方法

1997 年至 2005 年间，166 例（年龄 65±8 岁）接受全主动脉根部置换的患者被随机分为同种异体移植物组（n=76）或 Freestyle 生物瓣组（n=90）。由于同种异体移植物尺寸不合适，随机分配至同种异体移植物组的 6 例患者交叉至 Freestyle 组。中位随访时间为 7.6 年（最长 11 年；1035 患者-年）。“进展性”主动脉瓣功能障碍定义为主动脉瓣反流≥2/4 级和/或峰值梯度>20mmHg。

结果

两组患者的特征无差异。Freestyle 和同种异体移植物组分别有 44%和 47%的患者同时行其他手术（p=0.5）。总住院死亡率为 4.8%（单纯根部置换为 1%）。Freestyle 组 8 年生存率为 80±5%，同种异体移植物组为 77±6%（p=0.9）。Freestyle 根部置换 8 年无再次手术率明显高于同种异体移植物置换（100±0%vs.90±5%；p=0.02）。所有再次手术均继发于结构性瓣膜退化（n=6）。最后一次超声心动图随访时，Freestyle 生物瓣的无进展性主动脉瓣功能障碍的实际无事件生存率为 86±5%，同种异体移植物为 37±7%（p<0.001）。临床方面，两组纽约心脏协会心功能 III 级至 IV 级的无事件生存率和瓣膜相关并发症的无事件生存率无差异（p=0.7 和 p=0.9）。