Yadlapati Ajay, Diep Jimmy, Barnes Mary-Jo, Grogan Tristan, Bethencourt Daniel M, Vorobiof Gabriel
J Heart Valve Dis. 2014 Jul;23(4):516-23.
The study aim was to evaluate the performance of a new stented pericardial bioprosthesis, the Trifecta (St. Jude Medical, St. Paul, MN, USA), for aortic valve replacement (AVR) with respect to valvular hemodynamics and frequency of patient-prosthesis mismatch (PPM). PPM has been reported in a wide range of bioprosthetic valves following AVR, and has been associated with multiple adverse outcomes. It was hypothesized that the Trifecta aortic valve would have superior hemodynamics and an acceptable incidence of PPM following AVR.
A prospective cohort study was performed between January 2010 and May 2012, following 75 patients (mean age 71.9 _ 11.1 years) who had undergone AVR with a Trifecta valve for aortic stenosis (88%) or regurgitation (12%) at the authors' institutions. Intraoperative three-dimensional and Doppler transesophageal echocardiography were used to evaluate hemodynamic variables before and after AVR, as well as pre-discharge.
Echocardiographic evaluation showed a preoperative average mean gradient (MG) of 40.6 ± 21.6 mmHg, an average peak gradient (PG) of 72.1 ± 19.4 mmHg, and an average effective orifice area index (EOAI) of 0.39 ± 0.20 cm2/m2. Postoperative mean pressure gradient measurements showed a postoperative average MG of 8.76 ± 3.75 mmHg (p < 0.001), an average PG of 19.4 ± 8.6 mmHg (p < 0.001), and EOAI of 1.09 ± 0.36 cm2/m2 (p < 0.001), which demonstrated a significantly improved hemodynamic performance across all valve sizes. Postoperative MG versus measured EOAI demonstrated a fairly linear relationship (R2 = 0.0703), rather than a rapid increase in MG with EOAI < 0.85 and < 0.65, as was seen with previous valve designs. Severe PPM (defined as EOAI ≤ 0.65 cm2/m2) was found in four patients (6%), while moderate PPM (EOAI > 0.65 and < 0.85 cm2/m2) was seen in 11 patients (16%).
The Trifecta pericardial valve demonstrated excellent hemodynamic performance at all valve sizes, and resulted in very low postoperative transvalvular pressure gradients and PPM, without the need for aortic root enlargement.
本研究旨在评估新型带支架心包生物瓣膜Trifecta（美国明尼苏达州圣保罗市圣犹达医疗公司）用于主动脉瓣置换术（AVR）时在瓣膜血流动力学及患者-人工瓣膜不匹配（PPM）发生率方面的表现。AVR术后多种生物瓣膜均有PPM的报道，且其与多种不良后果相关。研究假设Trifecta主动脉瓣在AVR术后将具有更优的血流动力学表现及可接受的PPM发生率。
2010年1月至2012年5月进行了一项前瞻性队列研究，随访了75例（平均年龄71.9±11.1岁）在作者所在机构接受Trifecta瓣膜AVR治疗主动脉狭窄（88%）或反流（12%）的患者。术中采用三维及多普勒经食管超声心动图评估AVR术前、术后及出院前的血流动力学变量。
超声心动图评估显示术前平均平均压差（MG）为40.6±21.6 mmHg，平均峰值压差（PG）为72.1±19.4 mmHg，平均有效瓣口面积指数（EOAI）为0.39±0.20 cm²/m²。术后平均压力阶差测量显示术后平均MG为8.76±3.75 mmHg（p<0.001），平均PG为19.4±8.6 mmHg（p<0.001），EOAI为1.09±0.36 cm²/m²（p<0.001），表明所有瓣膜尺寸的血流动力学表现均有显著改善。术后MG与实测EOAI呈相当线性的关系（R² = 0.0703），而非像之前瓣膜设计那样在EOAI<0.85和<0.65时MG迅速升高。4例患者（6%）出现严重PPM（定义为EOAI≤0.65 cm²/m²），11例患者（16%）出现中度PPM（EOAI>0.65且<0.85 cm²/m²）。
Trifecta心包瓣膜在所有瓣膜尺寸下均表现出优异的血流动力学性能，术后跨瓣压差及PPM极低，无需扩大主动脉根部。
