Burzotta Francesco, Aurigemma Cristina, Kovacevic Mila, Romagnoli Enrico, Cangemi Stefano, Bianchini Francecso, Nesta Marialisa, Bruno Piergiorgio, Trani Carlo
Dipartimento di Scienze Cardiovascolari, Fondazione Policlinico Universitario A Gemelli IRCCS, Rome 00168, Italy.
Faculty of Medicine, University of Novi Sad, Novi Sad, Serbia.
World J Cardiol. 2022 May 26;14(5):297-306. doi: 10.4330/wjc.v14.i5.297.
The use of pre-closure suture-based devices represents a widely access-site hemostasis technique in percutaneous transfemoral transcatheter-aortic-valve-replacement (TF-TAVR); yet this technique is associated with the risk of a device failure that may result in clinically relevant residual bleeding. Thus, a bailout intervention is needed. So far, the best management of pre-closure device failure has not been recognized.
To report the first clinical results obtained using a novel bailout hemostasis technique for patients with double suture-based vascular closure device failure in the setting of TF-TAVR.
We developed a "pledget-assisted hemostasis" technique to manage residual access-site bleeding. This consists of the insertion of a surgical, non-absorbable, polytetrafluoroethylene pledget over the sutures of the two ProGlide (Abbott Vascular, CA, United States). The ProGlide's knot-pushers are used to push down the pledget and the hand-made slipknot to seal the femoral artery leak. This technique was used as a bailout strategy in patients undergoing TF-TAVR with a systematic double pre-closure technique. Post-procedural access-site angiography was systematically performed. In-hospital complications were systematically detected and classified according to Valve Academic Research Consortium-2 criteria.
Out of 136 consecutive patients who underwent TF-TAVR, 15 patients (mean age 80.0 ± 7.2 years, 66.7% female) with access-site bleeding after double pre-closure technique failure were treated by pledget-assisted hemostasis. In the majority of patients, 16F sheath was used ( = 12; 80%). In 2 cases (13%), a peripheral balloon was also inflated in the iliac artery to limit blood loss during pledget preparation. Angiography-confirmed hemostasis (primary efficacy endpoint) was achieved in all patients. After the procedure, 1 patient required blood transfusion (2 units), and no other bleeding or major ischemic complication was noticed.
The "pledget assisted hemostasis" might be considered as a possible bailout technique to treat patients with residual access site bleeding. Further studies are needed to compare this approach with other bail-out techniques.
基于预闭合缝合的装置的使用是经皮股动脉经导管主动脉瓣置换术（TF-TAVR）中广泛应用的一种穿刺部位止血技术；然而，该技术存在装置故障的风险，这可能导致具有临床意义的残余出血。因此，需要一种补救干预措施。到目前为止，预闭合装置故障的最佳处理方法尚未明确。
报告在TF-TAVR中，针对基于双缝合的血管闭合装置故障患者，使用一种新型补救止血技术所获得的首批临床结果。
我们开发了一种“棉垫辅助止血”技术来处理残余穿刺部位出血。该技术包括在两个ProGlide（美国加利福尼亚州雅培血管公司）的缝合线上方插入一个外科用、不可吸收的聚四氟乙烯棉垫。使用ProGlide的推结器将棉垫向下推，并使用手工制作的活结来封闭股动脉漏血处。在接受TF-TAVR且采用系统性双预闭合技术的患者中，该技术被用作一种补救策略。术后系统性地进行穿刺部位血管造影。根据瓣膜学术研究联盟-2标准系统性地检测并分类院内并发症。
在连续136例行TF-TAVR的患者中，15例（平均年龄80.0±7.2岁，66.7%为女性）在双预闭合技术失败后出现穿刺部位出血，接受了棉垫辅助止血治疗。大多数患者使用16F鞘管（n = 12；80%）。2例（13%）患者在髂动脉中也充盈了外周球囊，以在准备棉垫期间限制失血。所有患者均实现了血管造影证实的止血（主要疗效终点）。术后，1例患者需要输血（2单位），未发现其他出血或严重缺血性并发症。
“棉垫辅助止血”可被视为治疗残余穿刺部位出血患者的一种可能的补救技术。需要进一步研究将该方法与其他补救技术进行比较。
