Auriemma Stefano, Bortolotti Uberto, Piccin Caterina, Brunelli Massimo, Magagna Paolo, Lamascese Nicola, Paccanaro Mariemma, Fabbri Alessandro
Division of Cardiac Surgery, San Bortolo Hospital, Vicenza, Italy.
Ital Heart J. 2004 Sep;5(9):673-7.
The Edwards Prima stentless valve (EPSV) is a bioprosthesis made of the porcine aortic root which, owing to its versatility, may be implanted with different techniques depending on the underlying disease. The aim of this study was to demonstrate the usefulness of the EPSV implanted as a miniroot in patients with disease of the aortic valve and ascending aorta.
Between January 1998 and July 2002, 91 patients (mean age 67 +/- 7 years) underwent combined replacement of the aortic valve and ascending aorta with an EPSV for aortic stenosis (n = 12), incompetence (n = 45) or mixed disease (n = 26); all had aneurysmal dilation of the ascending aorta and 8 had an acute aortic dissection. The EPSV was implanted using the miniroot (or inclusion) technique and by extending the aorta with a tubular graft; aortic arch replacement was required in 5 patients. Hospital survivors underwent clinical and echocardiographic follow-up at 6 and 12 months and yearly thereafter.
The hospital mortality was 11% (10 patients). Causes of death included stroke (n = 3), septic shock (n = 3), myocardial infarction (n = 2), and low output syndrome (n = 2). The mean follow-up of the 81 discharged patients was 16 +/- 13 months and was 100% complete; there were 6 late deaths due to non-cardiac causes. All patients presented with clinical improvement (95% are in NYHA functional class I) with low transvalvular gradients and significant regression of left ventricular hypertrophy at two-dimensional echocardiography.
The EPSV used as a miniroot has proved to be a valid option in patients requiring simultaneous replacement of the aortic valve and ascending aorta. Due to the limited information available on the long-term fate of the porcine aortic valve and root, the use of this device as a miniroot should presently be limited to elderly patients.
爱德华兹 Prima 无支架瓣膜（EPSV）是一种由猪主动脉根部制成的生物假体，由于其多功能性，可根据潜在疾病采用不同技术进行植入。本研究的目的是证明 EPSV 作为迷你根部植入主动脉瓣和升主动脉疾病患者中的有效性。
1998 年 1 月至 2002 年 7 月期间，91 例患者（平均年龄 67±7 岁）因主动脉瓣狭窄（n = 12）、关闭不全（n = 45）或混合性疾病（n = 26）接受了 EPSV 联合主动脉瓣和升主动脉置换术；所有患者均有升主动脉瘤样扩张，8 例有急性主动脉夹层。EPSV 采用迷你根部（或包埋）技术并通过用管状移植物延长主动脉进行植入；5 例患者需要进行主动脉弓置换。医院幸存者在 6 个月和 12 个月时接受临床和超声心动图随访，此后每年随访一次。
医院死亡率为 11%（10 例患者）。死亡原因包括中风（n = 3）、感染性休克（n = 3）、心肌梗死（n = 2）和低心排血量综合征（n = 2）。81 例出院患者的平均随访时间为 16±13 个月，随访率为 100%；有 6 例因非心脏原因导致的晚期死亡。所有患者临床症状均有改善（95%处于纽约心脏协会心功能 I 级），跨瓣压差低，二维超声心动图显示左心室肥厚明显减轻。
EPSV 作为迷你根部已被证明是需要同时置换主动脉瓣和升主动脉的患者的有效选择。由于关于猪主动脉瓣和根部长期转归的信息有限，目前将该装置作为迷你根部的应用应限于老年患者。
