Montalto Claudio, Munafò Andrea Raffaele, Arzuffi Luca, Soriano Francesco, Mangieri Antonio, Nava Stefano, De Maria Giovanni Luigi, Burzotta Francesco, D'Ascenzo Fabrizio, Colombo Antonio, Latib Azeem, Oreglia Jacopo Andrea, Banning Adrian P, Porto Italo, Crimi Gabriele
Department of Molecular Medicine, University of Pavia, 27100 Pavia, Italy.
De Gasperis Cardio Center, Interventional Cardiology Unit, Niguarda Hospital, 20172 Milan, Italy.
Eur Heart J Open. 2022 Aug 18;2(4):oeac043. doi: 10.1093/ehjopen/oeac043. eCollection 2022 Jul.
As the indications to transcatheter aortic valve replacement (TAVR) expand to patients at increasingly lower risk, procedure-related vascular and bleeding complications events must be minimized. We aimed to evaluate the impact of different large-bore arterial access closure devices on clinical outcomes after TAVR.
We searched for papers that reported outcomes according to the type of vascular closure device/technique used after TAVR and performed a Bayesian network meta-analysis (NMA). Fifteen studies involving 9259 patients who underwent access site closure using PROSTAR™ XL percutaneous vascular surgical system (Abbott Vascular, Santa Clara, CA, USA), Perclose ProGlide™ suture-mediated closure system (Abbott), or MANTA vascular closure device (Teleflex, Morrisville, NC, USA) were included. NMA showed MANTA to have the highest likelihood of reducing a primary composite endpoint of intra-hospital death, major vascular complications, and major or life-threatening bleedings [surface under the cumulative ranking curve analysis (SUCRA) 94.8%], but this was mitigated when only randomized clinical trials and propensity-matched cohorts were included (SUCRA 56.1%). The ProGlide showed the highest likelihood to reduce major or life-threatening bleedings, especially with increasing procedural complexity, and the MANTA device to reduce major and minor vascular complications. The ProStar XL device performed poorly in all explored endpoints.
Available evidence summarized through a NMA shows that ProGlide and MANTA devices appear to be both valid vascular closure devices globally and to be the best options to minimize vascular complications and reduce bleeding in patients undergoing TAVR, respectively.
随着经导管主动脉瓣置换术（TAVR）的适应症扩展到风险越来越低的患者，与手术相关的血管和出血并发症事件必须降至最低。我们旨在评估不同的大口径动脉入路闭合装置对TAVR术后临床结局的影响。
我们检索了报告TAVR术后根据所使用的血管闭合装置/技术类型得出的结局的论文，并进行了贝叶斯网络荟萃分析（NMA）。纳入了15项研究，涉及9259例使用PROSTAR™ XL经皮血管手术系统（美国加利福尼亚州圣克拉拉市雅培血管公司）、Perclose ProGlide™ 缝线介导闭合系统（雅培）或MANTA血管闭合装置（美国北卡罗来纳州莫里斯维尔市泰利福公司）进行入路部位闭合的患者。NMA显示，MANTA降低院内死亡、主要血管并发症和重大或危及生命的出血的主要复合终点的可能性最高[累积排名曲线分析（SUCRA）下的面积为94.8%]，但仅纳入随机临床试验和倾向匹配队列时，这种情况有所缓解（SUCRA为56.1%）。ProGlide显示降低重大或危及生命的出血可能性最高，尤其是随着手术复杂性增加时，而MANTA装置降低主要和次要血管并发症的可能性最高。ProStar XL装置在所有探索的终点方面表现不佳。
通过NMA总结的现有证据表明，ProGlide和MANTA装置在全球范围内似乎都是有效的血管闭合装置，分别是将TAVR患者的血管并发症降至最低和减少出血的最佳选择。
