西洛生涂层与瓣周漏：一项独立随机研究。

Herijgers P, Herregods M C, Vandeplas A, Meyns B, Flameng W

Department of Cardiac Surgery, UZ Gasthuisberg, Katholieke Universiteit Leuven, Belgium.

J Heart Valve Dis. 2001 Nov;10(6):712-5; discussion 715-6.

BACKGROUND AND AIM OF THE STUDY

The study aim was to address independently, in a randomized patient cohort, the impact of Silzone coating on the prevalence and impact of paravalvular leak in patients undergoing mechanical valve replacement.

METHODS

Randomized implantation of the uncoated St. Jude Medical Masters, and the Silzone-coated prosthesis was performed in 95 patients, excluding those with suspected or diagnosed infective endocarditis. The company did not support the study; this cohort is not contained in the AVERT trial. Following recall of the Silzone-coated valves, all patients in this cohort were invited to undergo control transthoracic echocardiography and plasma LDH determination.

RESULTS

Silzone-coated valves were implanted in 46 patients (57 valves; 34 aortic, 20 mitral, three tricuspid), and uncoated valves in 49 patients (55 valves; 38 aortic, 16 mitral, one tricuspid). One patient with an uncoated mitral valve died from left ventricular dissection. In total, 73 patients returned for specifically planned echocardiography (mean interval 478+/-78 days). Sixteen patients underwent echocardiography on another occasion (mean interval 113+/-202 days). Six hospital survivors did not undergo any postoperative echocardiography. In total, 51 Silzone-coated valves (31 aortic, 18 mitral, two tricuspid), and 53 uncoated valves (37 aortic, 15 mitral, one tricuspid) were evaluated. No patients were reoperated for intrinsic or extrinsic valve dysfunction. No major paravalvular leaks were seen. Five of 51 Silzone-coated valves showed minimal (grade <1+; four aortic, one mitral) paravalvular leak when specifically sought; two showed minimal (grade <1+; one aortic, one mitral), and one slight (grade 1+; one mitral) paravalvular leak in the uncoated group (p = 0.55). The LDH level was 654+/-163 U/I in the Silzone group, and 598+/-124 U/l in the control group (p = 0.10).

CONCLUSION

No differences were detected in the incidence of paravalvular leak between Silzone-coated and uncoated mechanical St. Jude Medical valves. The incidence of major paravalvular leaks appears to be lower in the present cohort than was reported in the AVERT trial.

研究背景与目的

本研究旨在独立探讨在接受机械瓣膜置换术的患者随机队列中，Silzone涂层对瓣周漏的发生率及影响。

方法

对95例患者（不包括疑似或确诊感染性心内膜炎患者）进行随机植入未涂层的圣犹达医疗公司Masters瓣膜和Silzone涂层瓣膜。该公司未支持本研究；此队列未纳入AVERT试验。在召回Silzone涂层瓣膜后，邀请该队列所有患者接受经胸超声心动图检查及血浆乳酸脱氢酶（LDH）测定。

结果

46例患者植入了Silzone涂层瓣膜（57枚瓣膜；34枚主动脉瓣、20枚二尖瓣、3枚三尖瓣），49例患者植入了未涂层瓣膜（55枚瓣膜；38枚主动脉瓣、16枚二尖瓣、1枚三尖瓣）。1例植入未涂层二尖瓣瓣膜的患者死于左心室夹层。共有73例患者按计划返回接受超声心动图检查（平均间隔478±78天）。16例患者在其他时间接受了超声心动图检查（平均间隔113±202天）。6例住院幸存者未接受任何术后超声心动图检查。总共评估了51枚Silzone涂层瓣膜（31枚主动脉瓣、18枚二尖瓣、2枚三尖瓣）和53枚未涂层瓣膜（37枚主动脉瓣、15枚二尖瓣、1枚三尖瓣）。没有患者因瓣膜内在或外在功能障碍接受再次手术。未发现严重瓣周漏。在特意检查时，51枚Silzone涂层瓣膜中有5枚显示轻微（<1+级；4枚主动脉瓣、1枚二尖瓣）瓣周漏；未涂层组有2枚显示轻微（<1+级；1枚主动脉瓣、1枚二尖瓣），1枚显示轻度（1+级；1枚二尖瓣）瓣周漏（p = 0.55）。Silzone组LDH水平为654±163 U/I，对照组为598±124 U/l（p = 0.10）。