Medizinische Klinik und Poliklinik II, Universitätsklinikum Bonn, Rheinische Friedrich-Wilhelms-Universität Bonn, Bonn, Germany.
EuroIntervention. 2015 Oct;11(6):698-704. doi: 10.4244/EIJY15M01_10.
In patients undergoing transcatheter aortic valve implantation (TAVI), the high prevalence of peripheral artery disease (PAD) limits femoral access and increases vascular complications that are associated with mortality and morbidity. Our study assessed the ability of a balloon-expandable large-bore vascular sheath to increase access-site availability and to reduce vascular complications.
Among 257 patients from two centres, 43 patients underwent transfemoral TAVI with the use of the SoloPath balloon-expandable sheath due to complex iliofemoral access anatomy. Propensity score matching (2:1) was performed except for the sheath to femoral artery ratio (SFAR). Compared to standard sheath patients, we found no significant difference in 30-day and one-year mortality (SoloPath vs. standard sheath, 9.3% vs. 3.5%; p=0.2, and 18.6% vs. 23.3%; p=0.7), major vascular complications (9.3% vs. 4.7%; p=0.3), and major bleeding (9.3% vs. 10.5%; p=0.5) in the cohort with the balloon-expandable sheath.
The use of a balloon-expandable large-bore sheath in patients with a high risk for vascular complications due to complex access-site anatomy proved to be feasible and safe. However, circumferential calcifications and sheath-to-artery ratios account for vascular access complications even in patients treated with the balloon-expandable sheath.
在接受经导管主动脉瓣置换术（TAVI）的患者中，外周动脉疾病（PAD）的高发率限制了股动脉入路，并增加了与死亡率和发病率相关的血管并发症。我们的研究评估了一种球囊扩张大口径血管鞘的能力，以增加入路部位的可用性并减少血管并发症。
在来自两个中心的 257 名患者中，由于复杂的髂股动脉解剖结构，43 名患者接受了经股 TAVI 治疗，使用了 SoloPath 球囊扩张鞘。除了鞘管与股动脉比（SFAR）外，还进行了倾向评分匹配（2:1）。与标准鞘管患者相比，我们发现 30 天和 1 年死亡率（SoloPath 与标准鞘管，9.3%与 3.5%；p=0.2，18.6%与 23.3%；p=0.7）、主要血管并发症（9.3%与 4.7%；p=0.3）和主要出血（9.3%与 10.5%；p=0.5）在球囊扩张鞘管组中无显著差异。
在由于复杂的入路解剖结构而存在血管并发症高风险的患者中使用球囊扩张大口径鞘管被证明是可行且安全的。然而，即使在接受球囊扩张鞘管治疗的患者中，周向钙化和鞘管与动脉比也会导致血管入路并发症。
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