Sakata Tomoki, Kuno Toshiki, Fujisaki Tomohiro, Yokoyama Yujiro, Misumida Naoki, Sugiura Tadahisa, Latib Azeem
Cardiovascular Research Institute, Icahn School of Medicine at Mount Sinai, New York, USA.
Division of Cardiology, Montefiore Medical Center, Albert Einstein College of Medicine, New York, USA.
Cardiovasc Revasc Med. 2023 Jan;46:78-84. doi: 10.1016/j.carrev.2022.08.011. Epub 2022 Aug 11.
Various vascular closure devices (VCDs) are commonly used for percutaneous transcatheter aortic valve replacement (TAVR). However, superiority and safety profile among them remain unclear. We compared periprocedural complications among various VCDs in patients undergoing TAVR. PubMed and EMBASE were searched through January 2022 to identify clinical studies comparing any 2 VCDs of Prostar, Proglide and MANTA in patients who underwent TAVR. Studies using surgical cut-down or alternative access other than transfemoral approach were excluded. We analyzed the odds ratios (ORs) of vascular complications (VC), bleeding, acute kidney injury and all-cause mortality using a network meta-analysis. All outcomes were defined by Valve Academic Research Consortium 2 criteria. Two randomized controlled trials and 15 observational studies were identified, yielding a total of 11,344 patients including Prostar (n = 4499), Proglide (n = 5705), or MANTA group (n = 1140). The rates of major VC and life-threatening and major bleeding were significantly lower in Proglide compared to Prostar (OR [95 % CI] = 0.54 [0.32-0.89], 0.68 [0.52-0.90], and 0.49 [0.26-0.95], respectively). There was no significant difference in major VC and bleeding between Proglide and MANTA groups. Proglide was associated with a lower rate of acute kidney injury (0.56 [0.34-0.92]) and red blood cell transfusion (0.39 [0.16-0.98]) compared to Prostar. There was no significant difference in additional interventions and 30-day overall mortality among three groups. In this network meta-analysis of VCD in patients undergoing TAVR, MANTA and Proglide had comparable outcomes while Proglide appears superior to Prostar in terms of major VC and bleeding.
各种血管闭合装置（VCD）常用于经皮经导管主动脉瓣置换术（TAVR）。然而，它们之间的优越性和安全性仍不明确。我们比较了接受TAVR的患者使用各种VCD时围手术期并发症的情况。检索了截至2022年1月的PubMed和EMBASE，以确定比较接受TAVR的患者中Prostar、Proglide和MANTA这三种VCD中任意两种的临床研究。排除使用手术切开或经股动脉途径以外的其他入路的研究。我们使用网状Meta分析分析血管并发症（VC）、出血、急性肾损伤和全因死亡率的比值比（OR）。所有结局均根据瓣膜学术研究联盟2标准定义。确定了两项随机对照试验和15项观察性研究，共纳入11344例患者，包括Prostar组（n = 4499）、Proglide组（n = 5705）或MANTA组（n = 1140）。与Prostar相比，Proglide的主要VC、危及生命和严重出血发生率显著更低（OR [95% CI]分别为0.54 [0.32 - 0.89]、0.68 [0.52 - 0.90]和0.49 [0.26 - 0.95]）。Proglide组和MANTA组之间的主要VC和出血无显著差异。与Prostar相比，Proglide的急性肾损伤发生率（0.56 [0.34 - 0.92]）和红细胞输注率（0.39 [0.16 - 0.98]）更低。三组之间的额外干预措施和30天总死亡率无显著差异。在这项针对接受TAVR的患者进行的VCD网状Meta分析中，MANTA和Proglide的结局相当，而Proglide在主要VC和出血方面似乎优于Prostar。
