用于主动脉瓣置换的Freedom SOLO瓣膜：一项前瞻性多中心试验的临床和血流动力学结果

The Freedom SOLO valve for aortic valve replacement: clinical and hemodynamic results from a prospective multicenter trial.

作者信息

Beholz Sven, Repossini Alberto, Livi Ugolino, Schepens Marc, El Gabry Mohamed, Matschke Klaus, Trivedi Uday, Eckel Lothar, Dapunt Otto, Zamorano José Luis

机构信息

Charité-University Medicine, Berlin, Germany.

出版信息

J Heart Valve Dis. 2010 Jan;19(1):115-23.

PMID:20329497

Abstract

BACKGROUND AND AIM OF THE STUDY

The study aim was to investigate the early results, hemodynamics and left ventricular remodeling after aortic valve replacement (AVR) with the Freedom SOLO valve, a bovine pericardial valve bioprosthesis, using a single running suture line in a supra-annular position.

METHODS

Between July 2004 and September 2006, a total of 256 patients (116 males; 140 females; mean age 74.5 +/- 6.4 years; range: 41-89 years) who underwent AVR with the Freedom SOLO valve in nine European institutions were enrolled in the study. The indications for AVR were stenosis in 182 patients, regurgitation in 15, and combined in 57. Preoperatively, 37%, 59% and 4% of the patients were in NYHA classes I-II, III, and IV, respectively. Concomitant procedures were performed in 91 patients (36%). A patient subgroup underwent echocardiography preoperatively (n=192), and at one (n=194) and 12 (n=165) months postoperatively.

RESULTS

The early mortality was 2.3% (n=6). There were 18 late deaths (6.2%/pt-yr). After 12 months, 82% of the patients were in NYHA class I-II. Linearized rates were 0.69%/pt-yr for bleeding, 0.34%/pt-yr for thromboembolism, 0.0%/pt-yr for structural degeneration and thrombosis, 1.37%/pt-yr for paravalvular leak, and 2.06%/pt-yr for endocarditis. Five patients required reoperation. Twelve-month transprosthetic regurgitation was graded as absent in 92% of cases. The mean gradient was 42.3 +/- 20.2 mmHg preoperatively, 6.5 +/- 3.8 mmHg at one month, and 6.7 +/- 4.1 mmHg at 12 months. The effective orifice area was improved from 0.78 +/- 0.35 cm2 preoperatively to 1.90 +/- 0.56 cm2 at one month and 1.89 +/- 0.56 cm2 at 12 months. The left ventricular mass was decreased by 23%, from 217.8 +/- 77.2 g/m2 preoperatively to 167.4 +/- 68.2 g/m2 at one year. The mean left ventricular ejection fraction was 65.5 +/- 14.2% preoperatively, and 64.5 +/- 12.5% and 66.0 +/- 10.6% at one month and at 12 months, respectively.

CONCLUSION

The data obtained suggest that the Freedom SOLO stentless bioprosthesis shows excellent early clinical and hemodynamic results, resulting in a significant regression of left ventricular hypertrophy and improvement in left ventricular systolic function.

摘要

研究背景与目的

本研究旨在探讨采用Freedom SOLO瓣膜（一种牛心包生物瓣膜假体）在瓣环上位置使用单一连续缝合线进行主动脉瓣置换（AVR）后的早期结果、血流动力学及左心室重塑情况。

方法

2004年7月至2006年9月期间，9家欧洲机构中共有256例接受Freedom SOLO瓣膜AVR的患者（116例男性；140例女性；平均年龄74.5±6.4岁；范围：41 - 89岁）纳入本研究。AVR的适应证为182例狭窄、15例反流以及57例两者并存。术前，分别有37%、59%和4%的患者处于纽约心脏协会（NYHA）心功能I - II级、III级和IV级。91例患者（36%）同时进行了其他手术。一个患者亚组在术前（n = 192）、术后1个月（n = 194）和12个月（n = 165）接受了超声心动图检查。

结果

早期死亡率为2.3%（n = 6）。有18例晚期死亡（6.2%/患者年）。12个月后，82%的患者处于NYHA I - II级。出血的线性化发生率为0.69%/患者年，血栓栓塞为0.34%/患者年，结构退变和血栓形成均为0.0%/患者年，瓣周漏为1.37%/患者年，心内膜炎为2.06%/患者年。5例患者需要再次手术。12个月时，92%的病例经人工瓣膜反流分级为无反流。术前平均压差为42.3±20.2 mmHg，1个月时为6.5±3.8 mmHg，12个月时为6.7±4.1 mmHg。有效瓣口面积从术前的0.78±0.35 cm²改善至1个月时的1.90±0.56 cm²以及12个月时的1.89±0.56 cm²。左心室质量从术前的217.8±77.2 g/m²下降了23%，至1年时为167.4±68.2 g/m²。术前平均左心室射血分数为65.5±14.2%，1个月时为64.5±12.5%，12个月时为66.0±10.6%。