Department of Cariology, Washington Hospital Center, Washington, DC, USA.
Catheter Cardiovasc Interv. 2011 Jul 1;78(1):119-24. doi: 10.1002/ccd.22940.
To compare complication rates of a collagen-mediated closure device, suture-mediated closure technique and manual compression for access site management following balloon aortic valvuloplasty (BAV).
Vascular complications, including perforation, limb ischemia, ateriovenous fistulas, and pseudoaneurysm, are a common source of morbidity in patients undergoing BAV with large bore femoral artery access. The available options for closure of the access site include manual compression, suture-mediated closure devices, and recently reported collagen-based closure devices.
The study cohort consisted of 333 patients with severe aortic stenosis undergoing BAV. Patients were divided into four groups according to access closure method: (1) Manual compression in 64 (19.2%); (2) Proglide 6 Fr in 162 (48.6%); (3) Angio-Seal 8 Fr in 89 (26.75%); and (4) Prostar 10 Fr in 18 (5.4%).
There were no significant differences in baseline characteristics among the groups; although the Prostar group was had more males and the Angio-Seal group reported a lower incidence of renal failure and peripheral vascular disease. The Angio-Seal group had shorter procedural duration times compared with the other groups. In the Angio-Seal group (n = 47, 52.8%), a 10 Fr sheath size was primarily used to access the femoral artery, as compared with the manual compression and Proglide groups, which used a 12 Fr sheath in 29 (45.3%) and 66 patients (40.7%), respectively. A 13 Fr sheath was used in the Prostar group (n = 11, 61.1%), P < 0.001. The device failure rate was significantly higher in the Proglide group (n = 20, 12.3%) as compared with Angio-Seal (n = 3, 3.3%) and Prostar groups (n = 1, 5.5%), P = 0.03. Serious vascular complications requiring intervention were significantly higher in the manual compression group (n = 11, 17.1%) compared with the Proglide (n = 11, 6.7%), Angio-Seal (n = 5, 5.6%), and Prostar groups (n = 5, 1%), P < 0.001. The requirement for blood transfusion in the Angio-Seal group was significantly lower (n = 7, 7.8%) as compared with the manual compression (n = 20, 31.2%), Proglide (n = 35, 21.6%), and Prostar groups (n = 5, 27.7%), P < 0.001.
In our case series, collagen-based closure devices and suture-mediated closure devices had fewer vascular complications than manual compression for hemostasis following BAV. Patient selection for collagen-based versus suture-mediated closure requires further study.
比较胶原介导的闭合装置、缝线介导的闭合技术和手动压迫在球囊主动脉瓣成形术（BAV）后用于血管入路管理的并发症发生率。
在接受大口径股动脉入路的 BAV 的患者中，血管并发症（包括穿孔、肢体缺血、动静脉瘘和假性动脉瘤）是发病率的常见来源。血管入路的闭合方法包括手动压迫、缝线介导的闭合装置和最近报道的基于胶原的闭合装置。
研究队列包括 333 例严重主动脉瓣狭窄患者行 BAV。患者根据入路闭合方法分为四组：（1）手动压迫 64 例（19.2%）；（2）Proglide 6Fr 162 例（48.6%）；（3）Angio-Seal 8Fr 89 例（26.75%）；（4）Prostar 10Fr 18 例（5.4%）。
各组间基线特征无显著差异；尽管 Prostar 组男性更多，Angio-Seal 组报告肾功能衰竭和外周血管疾病的发生率较低。与其他组相比，Angio-Seal 组的手术时间更短。在 Angio-Seal 组（n=47，52.8%）中，主要使用 10Fr 鞘管进入股动脉，而手动压迫和 Proglide 组分别有 29 例（45.3%）和 66 例（40.7%）使用 12Fr 鞘管。Prostar 组使用 13Fr 鞘管（n=11，61.1%），P<0.001。Proglide 组（n=20，12.3%）的器械失败率明显高于 Angio-Seal 组（n=3，3.3%）和 Prostar 组（n=1，5.5%），P=0.03。需要介入治疗的严重血管并发症在手动压迫组（n=11，17.1%）明显高于 Proglide 组（n=11，6.7%）、Angio-Seal 组（n=5，5.6%）和 Prostar 组（n=5，1%），P<0.001。Angio-Seal 组的输血需求（n=7，7.8%）明显低于手动压迫组（n=20，31.2%）、Proglide 组（n=35，21.6%）和 Prostar 组（n=5，27.7%），P<0.001。
在我们的病例系列中，胶原基闭合装置和缝线介导的闭合装置在 BAV 后止血时血管并发症较手动压迫少。胶原基与缝线介导闭合装置的患者选择需要进一步研究。
