■这项单中心研究旨在评估接受联合单一Perclose(雅培,雅培公园,Illinois)Suture-MediatedClosureDevice+singleAngio-SealVIP8F(Terumo,东京,日本)并将结果与标准DualPerclose技术进行比较。材料和方法:2022年11月至2023年11月连续择期pEVAR患者,股骨入路健康,导管鞘≤20French(F)外径,包括在内。投币随机化确定是否使用了单个Perclose设备+单个Angio-SealVIP8F(混合技术)或标准双Perclose设备(DualPerclose)的组合。在混合技术中,在12点放置一个Perclose装置;去除鞘后放置一个Angio-SealVIP8F。DualPerclose遵循标准程序。主要终点包括立即止血,鞘管直径差异,访问转换率,技术上的成功,和成本分析。
■该研究纳入60名符合纳入标准的pEVAR患者(中位年龄=78岁,四分位距[IQR]=72-85岁)。在14例(24%)中,仅研究了1个股骨入路。有106个pEVAR访问,混合技术组58(54.7%),双重Perclose组48(45.3%)。两组在术前特征和鞘管直径方面均表现出均匀性(HybridTechnology-16FvsDualPerclose-18F;p=0.202)。混合技术组的即时止血率为100%,而DualPerclose组的止血率为87.5%(p=0.006)。手术通路转换是不必要的。技术成功100%,DualPerclose术后所有6例股出血病例血管内消退,使用额外的设备。成本分析显示,混合技术组的中位成本为330欧元(IQR=0),而DualPerclose组的中位成本为384欧元(IQR=360-456)(p<0.001)。30天死亡率为3%,在两个脆弱的病人中,没有通路相关的并发症。多变量分析确定DualPerclose通路(比值比[OR]=35.6;95%置信区间[CI]=18.3-36.8;p<0.001)和肥胖(OR=19.7;95%CI=1.4-23.9.5;p<0.001)是立即止血失败的独立危险因素。中位随访时间为134天(IQR=41-227),用1例混合技术(2%)成功地在62天后注射凝血酶治疗了小的股骨假性动脉瘤。
■在选定患者的pEVAR期间,选择性混合技术与单个Perclose装置+单个血管密封VIP8F的组合似乎不劣于标准的DualPerclose程序。它显示了减少立即止血失败和成本的积极趋势。两种程序均获得了技术上的成功,并避免了手术进入转换。
结论:本研究引入了一种新的选择性混合技术,该技术将单个Perclose装置与单个Angio-SealVIP8Fr相结合,用于经皮血管内腹主动脉介入治疗。混合技术的结果显示100%的技术成功和有效的立即止血,同时成本低于标准的双重Perclose程序。两种手术都不需要手术转换。尽管是单中心研究,它证明了这种混合技术有意应用于微创的潜在好处。肥胖和双重Perclose技术被确定为止血失败的独立危险因素。重申混合技术程序的有效性以及与标准程序的非劣效性。
UNASSIGNED: This single-center study aimed to assess patients who underwent intentional percutaneous endovascular aortic aneurysm repair (pEVAR) with Hybrid Technique combining a single Perclose (Abbott, Abbott Park, Illinois) Suture-Mediated Closure Device + single Angio-Seal VIP 8F (Terumo, Tokyo, Japan) and compare outcomes with the standard Dual Perclose technique. Materials and Methods: Consecutive elective pEVAR patients treated from November 2022 to November 2023, with healthy femoral accesses and introducer sheaths ≤20 French (F) outer diameter, were included. Coin-toss randomization determined whether a combination of single Perclose Device + single Angio-Seal VIP 8F (Hybrid Technique) or the standard double Perclose Devices (Dual Perclose) was used. In Hybrid Technique, a single Perclose device was positioned at 12 o\'clock; a single Angio-Seal VIP 8F was placed after sheaths removal. Dual Perclose followed standard procedure. Primary endpoints included immediate hemostasis, sheath diameter differences, access conversion rate, technical success, and cost analysis.
UNASSIGNED: The study involved 60 pEVAR patients (median age=78, interquartile range [IQR]=72-85 years) within the inclusion criteria. In 14 (24%) cases, only 1 femoral access was studied. There were 106 pEVAR accesses, with 58 (54.7%) in the Hybrid Technique group and 48 (45.3%) in the Dual Perclose group. Both groups exhibited homogeneity in pre-operative characteristics and sheath diameter (Hybrid Technique-16F vs Dual Perclose-18F; p=0.202). Immediate hemostasis was achieved in 100% of the Hybrid Technique group vs 87.5% for the Dual Perclose group (p=0.006). Surgical access conversion was unnecessary. Technical success was 100%, with all 6 femoral bleeding cases after Dual Perclose resolved endovascularly, using additional devices. Cost analysis showed a median cost of 330 euros (IQR=0) for the Hybrid Technique group vs 384 euros (IQR=360-456) for the Dual Perclose group (p<0.001). Thirty-day mortality was 3%, in 2 fragile patients, without access-related complications. Multivariate analysis identified Dual Perclose access (odds ratio [OR]=35.6; 95% confidence interval [CI]=18.3-36.8; p<0.001) and obesity (OR=19.7; 95% CI=1.4-23.9.5; p<0.001) as independent risk factors for immediate hemostasis failure. Median follow-up was 134 days (IQR=41-227), with 1 Hybrid Technique case (2%) successfully treated with thrombin injection for a small femoral pseudoaneurysm after 62 days.
UNASSIGNED: The elective Hybrid Technique with combination of single Perclose Device + single Angio-Seal VIP 8F during pEVAR in selected patients appears to be non-inferior to the standard Dual Perclose procedure. It demonstrates a positive trend in reducing immediate hemostasis failure and costs. Both procedures achieved technical success and avoiding surgical access conversions.
CONCLUSIONS: This study introduces a novel elective hybrid technique combining a single Perclose device with a single Angio-Seal VIP 8Fr for percutaneous endovascular abdominal aortic interventions. Results for hybrid technique showed 100% technical success and efficient immediate hemostasis, while costing less than standard dual Perclose procedure. Both procedures did not require surgical conversions. Despite being a single-center study, it demonstrates potential benefits of the intentional application of this hybrid technique towards minimally invasiveness. Obesity and dual Perclose technique were identified as independent risk factors for hemostasis failure, reaffirming the hybrid technique procedure\'s efficacy as well as and non-inferiority to standard procedure.