Borger Michael A, Dohmen Pascal M, Knosalla Christoph, Hammerschmidt Robert, Merk Denis R, Richter Markus, Doenst Torsten, Conradi Lenard, Treede Hendrik, Moustafine Vadim, Holzhey David M, Duhay Francis, Strauch Justus
Columbia University Medical Center, New York, NY, USA
Leipzig Heart Center, Leipzig, Germany.
Eur J Cardiothorac Surg. 2016 Oct;50(4):713-720. doi: 10.1093/ejcts/ezw042. Epub 2016 Mar 2.
Aortic valve replacement (AVR) via minimally invasive surgery (MIS) may provide clinical benefits in patients with aortic valve disease. A new class of bioprosthetic valves that enable rapid deployment AVR (RDAVR) may facilitate MIS. We here report the 1-year results of a randomized, multicentre trial comparing the outcomes for MIS-RDAVR with those for conventional AVR via full sternotomy (FS) with a commercially available stented aortic bioprosthesis.
A total of 100 patients with aortic stenosis were enrolled in a prospective, multicentre, randomized comparison trial (CADENCE-MIS). Key exclusion criteria included AVR requiring concomitant procedures, ejection fraction of <25% and recent myocardial infarction or stroke. Patients were randomized to undergo MIS-RDAVR via upper hemisternotomy (EDWARDS INTUITY) or AVR via FS with a commercially available stented valve. Procedural, early and late clinical outcomes were assessed for both groups. Haemodynamic performance was evaluated by an echocardiography CoreLaboratory.
Technical success was achieved in 94% of MIS-RDAVR patients. MIS-RDAVR was associated with significantly reduced cross-clamp times compared with FS (41.3 ± 20.3 vs 54.0 ± 20.3 min, P < 0.001). Clinical and functional outcomes were similar at 30 days and 1 year postoperatively for both groups. While both groups received a similarly sized implanted valve (22.9 ± 2.1 mm MIS-RDAVR vs 23.0 ± 2.1 mm FS-AVR; P = 0.91), MIS-RDAVR patients had significantly lower peak gradients 1 year postoperatively (16.9 ± 5.3 vs 21.9 ± 8.6 mmHg; P = 0.033) and a trend towards lower mean gradients (9.1 ± 2.9 vs 11.5 ± 4.3 mmHg; P = 0.082). In addition, MIS-RDAVR patients had a significantly larger effective orifice area 1 year postoperatively (1.9 ± 0.5 vs 1.7 ± 0.4 cm; P = 0.047). Paravalvular leaks, however, were significantly more common in the MIS-RDAVR group (P = 0.027).
MIS-RDAVR is associated with a significantly reduced cross-clamp time and better valvular haemodynamic function than FS-AVR. However, paravalvular leak rates are higher with MIS-RDAVR.
通过微创手术（MIS）进行主动脉瓣置换术（AVR）可能为主动脉瓣疾病患者带来临床益处。一类新型的能够实现快速部署主动脉瓣置换术（RDAVR）的生物假体瓣膜可能会促进微创手术。我们在此报告一项随机、多中心试验的1年结果，该试验比较了MIS-RDAVR与通过全胸骨切开术（FS）使用市售带支架主动脉生物假体进行传统AVR的结果。
总共100例主动脉狭窄患者被纳入一项前瞻性、多中心、随机对照试验（CADENCE-MIS）。主要排除标准包括需要同期进行其他手术的AVR、射血分数<25%以及近期心肌梗死或中风。患者被随机分配接受通过上半胸骨切开术进行的MIS-RDAVR（爱德华兹INTUITY）或通过FS使用市售带支架瓣膜进行AVR。对两组的手术、早期和晚期临床结果进行评估。血流动力学性能由超声心动图核心实验室评估。
94%的MIS-RDAVR患者手术成功。与FS相比，MIS-RDAVR的主动脉阻断时间显著缩短（41.3±20.3分钟对54.0±20.3分钟，P<0.001）。两组术后30天和1年的临床和功能结果相似。虽然两组植入的瓣膜尺寸相似（MIS-RDAVR为22.9±2.1毫米，FS-AVR为23.0±2.1毫米；P=0.91），但MIS-RDAVR患者术后1年的峰值梯度显著更低（16.9±5.3对21.9±8.6毫米汞柱；P=0.033），平均梯度有降低趋势（9.1±2.9对11.5±4.3毫米汞柱；P=0.082）。此外，MIS-RDAVR患者术后1年的有效瓣口面积显著更大（1.9±0.5对1.7±0.4平方厘米；P=0.047）。然而，瓣周漏在MIS-RDAVR组中明显更常见（P=0.027）。
与FS-AVR相比，MIS-RDAVR的主动脉阻断时间显著缩短，瓣膜血流动力学功能更好。然而，MIS-RDAVR的瓣周漏发生率更高。
