Deutsches Herzzentrum München, Technische Universität München, Munich, Germany.
EuroIntervention. 2017 Oct 20;13(8):928-934. doi: 10.4244/EIJ-D-16-01036.
The aim of this study was to evaluate vascular complications using the "parallel suture technique" in patients receiving an Edwards SAPIEN XT (SXT) or SAPIEN S3 (S3) transcatheter heart valve (THV).
Two hundred consecutive patients with symptomatic severe aortic stenosis treated with TF-TAVI were included in this study where the "parallel suture technique" was applied for vascular access-site closure. This was achieved by placing the sutures medial and lateral to the puncture site. Vascular access-site complications were defined as vascular dissection, perforation, obstruction, arteriovenous fistula or pseudoaneurysms, and classified according to the Valve Academic Research Consortium-2 (VARC-2) criteria. Duplex sonography was performed routinely in every patient. In patients receiving the S3, the sheath to femoral and iliac artery ratio was significantly lower than in the SXT group, reflecting reduction in sheath sizes for S3. More endovascular interventions were required after SXT implantation as compared to S3 (4% versus 1%, p=0.02). This was due to vascular obstruction or device failure. Moreover, increased life-threatening, major bleedings, and pseudoaneurysms were found in the SXT group (6% versus 1%, p=0.06, 13% versus 3%, p=0.009, 7% versus 1%, p=0.03, respectively).
The "parallel suture technique" using the ProGlide is associated with a low number of vascular complications, even when using larger sheath sizes.
本研究旨在评估使用“平行缝线技术”在接受 Edwards SAPIEN XT(SXT)或 SAPIEN S3(S3)经导管心脏瓣膜(THV)治疗的患者中发生血管并发症的情况。
本研究纳入了 200 例接受经股心尖 TAVI(TF-TAVI)治疗的有症状严重主动脉瓣狭窄患者,在这些患者中应用了“平行缝线技术”进行血管入路部位闭合。这是通过将缝线置于穿刺部位的内侧和外侧来实现的。血管入路部位并发症定义为血管夹层、穿孔、阻塞、动静脉瘘或假性动脉瘤,并根据 Valve Academic Research Consortium-2(VARC-2)标准进行分类。对每位患者均常规进行了双功能超声检查。在接受 S3 治疗的患者中,鞘管与股动脉和髂动脉的比值明显低于 SXT 组,这反映了 S3 鞘管尺寸的减小。与 S3 相比,SXT 植入后需要更多的血管内介入治疗(4%比 1%,p=0.02)。这是由于血管阻塞或器械故障所致。此外,SXT 组发现更多危及生命的严重出血和假性动脉瘤(6%比 1%,p=0.06,13%比 3%,p=0.009,7%比 1%,p=0.03)。
即使使用较大的鞘管尺寸,使用 ProGlide 的“平行缝线技术”也与较低的血管并发症发生率相关。