Wahlers Thorsten C W, Andreas Martin, Rahmanian Parwis, Candolfi Pascal, Zemanova Barbora, Giot Christophe, Ferrari Enrico, Laufer Günther
Department of Cardiac Surgery, Medical University of Vienna, Vienna, Austria.
Edwards Lifesciences SA, Nyon, Switzerland.
Innovations (Phila). 2018 May/Jun;13(3):177-183. doi: 10.1097/IMI.0000000000000509.
The aim of this study was to compare outcomes after rapid-deployment aortic valve replacement (RDAVR) and conventional aortic valve replacement (AVR) from two studies.
Patients who underwent RDAVR (INTUITY valve) in the prospective, 5-year, single-arm multicenter TRITON study, or conventional AVR (Perimount Magna Ease valve) in the prospective Perimount Magna Ease postmarket study, were propensity score matched and compared for procedural, hemodynamic, safety, and clinical outcomes.
Matched RDAVR (n = 106) and conventional AVR (n = 106) patients had similar baseline characteristics (mean ± SD age, 72.8 ± 7.6 vs 72.5 ± 7.4 years; male 59.4% vs 61.3%) and procedures (concomitant procedures: 41.5% vs 50.9%). Mean ± SD aortic cross-clamp time was significantly shorter in RDAVR than AVR patients (51.8 ± 20.9 vs 73.9 ± 33.2 minutes; P < 0.001), as was mean cardiopulmonary bypass time (82.8 ± 34.2 vs 102.4 ± 41.7 minutes; P < 0.001). At 1 year, RDAVR patients showed significantly lower mean ± SD and peak aortic valve gradients (9.0 ± 3.4 and 17.0 ± 6.2 mm Hg, respectively) than conventional AVR patients (13.4 ± 5.5 and 24.2 ± 10.8 mm Hg, respectively; all P < 0.001). Patient-prosthesis mismatch was significantly less common with RDAVR than with AVR [overall: 16/66 (24.2%) vs 46/76 (60.5%); P = 0.007; severe: 2/66 (3.0%) vs 13/76 (17.1%)]. There were no significant differences between the RDAVR and AVR groups regarding 30-day safety endpoints. Survival rates in the RDAVR and conventional AVR groups were, respectively, 99.1% and 100.0% at 30 days, 97.1% and 95.1% at 1 year, and 93.3% and 94.1% at 3 years (P = nonsignificant).
In this retrospective study with matched populations, the RDAVR with the INTUITY valve system provided superior procedural and hemodynamic outcomes than a standard bioprosthesis without compromising safety.
本研究旨在比较两项研究中快速部署主动脉瓣置换术（RDAVR）与传统主动脉瓣置换术（AVR）后的结果。
在前瞻性、为期5年的单臂多中心TRITON研究中接受RDAVR（INTUITY瓣膜）的患者，或在前瞻性Perimount Magna Ease上市后研究中接受传统AVR（Perimount Magna Ease瓣膜）的患者，进行倾向评分匹配，并比较其手术、血流动力学、安全性和临床结果。
匹配的RDAVR（n = 106）和传统AVR（n = 106）患者具有相似的基线特征（平均±标准差年龄，72.8±7.6岁对72.5±7.4岁；男性59.4%对61.3%）和手术情况（同期手术：41.5%对50.9%）。RDAVR患者的平均±标准差主动脉阻断时间显著短于AVR患者（51.8±20.9分钟对73.9±33.2分钟；P < 0.001），平均体外循环时间也是如此（82.8±34.2分钟对102.4±41.7分钟；P < 0.001）。在1年时，RDAVR患者的平均±标准差和峰值主动脉瓣压差显著低于传统AVR患者（分别为9.0±3.4和17.0±6.2 mmHg，对13.4±5.5和24.2±10.8 mmHg；所有P < 0.001）。RDAVR患者的人工瓣膜-患者不匹配情况明显少于AVR患者[总体：16/66（24.2%）对46/76（60.5%）；P = 0.007；严重：2/66（3.0%）对13/76（17.1%）]。RDAVR组和AVR组在30天安全性终点方面无显著差异。RDAVR组和传统AVR组的生存率在30天时分别为99.1%和100.0%，1年时分别为97.1%和95.1%，3年时分别为93.3%和94.1%（P = 无显著性差异）。
在这项匹配人群的回顾性研究中，采用INTUITY瓣膜系统的RDAVR在不影响安全性的情况下，提供了优于标准生物假体的手术和血流动力学结果。
