Auriemma Stefano, D'Onofrio Augusto, Brunelli Massimo, Magagna Paolo, Paccanaro Mariemma, Rulfo Fanny, Fabbri Alessandro
Division of Cardiac Surgery San Bortolo Hospital, Vicenza, Italy.
J Heart Valve Dis. 2006 Sep;15(5):691-5; discussion 695.
The Edwards Lifesciences Prima Plus stentless valve (ELSV) is a bioprosthesis manufactured from a porcine aortic root. The study aim was to evaluate late clinical outcomes after aortic valve replacement (AVR) with ELSV implanted as a miniroot in patients with aortic valve disease.
Between 1993 and 2004, 318 patients (232 males, 86 females; mean age 69 +/- 9 years; range: 37-83 years) underwent AVR with the ELSV. Preoperatively, 102 patients (32%), 162 (51%) and 54 (17%) were in NYHA classes I/II, III and IV, respectively. Aortic stenosis, aortic regurgitation and combined lesions were present in 124 patients (39%), 114 (36%) and 41 (13%), respectively. Twenty patients (6%) were referred for an acute aortic dissection, 20 (6%) for an aortic root aneurysm, and 139 (44%) had an associated aneurysmal dilatation of the ascending aorta. The ascending aorta was replaced in 159 patients (50%); aortic arch replacement was required in 10 (3%). Coronary artery bypass graft was performed in 86 patients (27%). The follow up was based on clinical data.
Operative mortality was 5% (n = 17). There were 49 late deaths (5.2%/pt-yr). Valve-related mortality occurred in 10 patients (1%/pt-yr). Actuarial survival at five and 10 years was 78% and 33%, respectively. Actuarial freedom from valve reoperation and structural valve deterioration at 10 years were 100% and 64%. Actuarial freedom from embolic events and endocarditis at 10 years were 84% and 81%, respectively.
The ELSV, when implanted as a miniroot, provided good early and long-term results in terms of survival and freedom from major complications.
爱德华生命科学公司的Prima Plus无支架瓣膜（ELSV）是一种由猪主动脉根部制成的生物假体。本研究的目的是评估在主动脉瓣疾病患者中，将ELSV作为微型根部植入进行主动脉瓣置换（AVR）后的晚期临床结局。
1993年至2004年间，318例患者（男性232例，女性86例；平均年龄69±9岁；范围：37 - 83岁）接受了ELSV AVR手术。术前，102例患者（32%）、162例（51%）和54例（17%）分别处于纽约心脏协会（NYHA）心功能分级I/II级、III级和IV级。主动脉瓣狭窄、主动脉瓣关闭不全和联合病变分别存在于124例患者（39%）、114例（36%）和41例（13%）中。20例患者（6%）因急性主动脉夹层转诊，20例（6%）因主动脉根部瘤转诊，139例（44%）伴有升主动脉瘤样扩张。159例患者（50%）进行了升主动脉置换；10例（3%）需要进行主动脉弓置换。86例患者（27%）进行了冠状动脉旁路移植术。随访基于临床数据。
手术死亡率为5%（n = 17）。有49例晚期死亡（5.2%/患者年）。瓣膜相关死亡率发生在10例患者中（1%/患者年）。5年和10年的精算生存率分别为78%和33%。10年时无需再次进行瓣膜手术和无瓣膜结构恶化的精算自由度分别为100%和64%。10年时无栓塞事件和心内膜炎的精算自由度分别为84%和81%。
ELSV作为微型根部植入时，在生存和无重大并发症方面提供了良好的早期和长期结果。
