中文摘要（第一部分）

经桡动脉入路对比经股动脉入路TACE治疗肝细胞癌患者的临床应用：一项随机对照研究

研究背景与目的

经桡动脉入路（transradial access, TRA）已在心脏介入中被广泛证实具有患者舒适度高、穿刺点并发症发生率低、住院时间短等优势，但在肝细胞癌（hepatocellular carcinoma, HCC）介入中TRA是否仍具有同样的优势，目前尚无高质量的循证医学证据。本研究旨在通过前瞻性随机对照试验对比TRA和经股动脉入路（transfemoral access, TFA）在HCC患者中行经动脉化疗栓塞（transarterial chemoembolization, TACE）治疗的术后满意度、治疗过程相关指标和安全性。

材料与方法

本研究是一项前瞻性随机对照临床试验，从2019年2月至2021年8月，纳入130名在中国医学科学院肿瘤医院介入治疗科初次接受TACE治疗的HCC患者，通过随机数法将患者随机分配到TRA组（n = 65）或TFA组（n = 65）。主要观察指标为患者下一次TACE手术的动脉入路倾向性（基于术后第一天患者舒适度调查问卷）。次要观察指标为患者术后健康相关生活质量（health-related quality of life, HRQoL）、TACE技术成功率、动脉入路转换率、造影剂用量、透视时间、手术时间、空气比释动能（air kerma, AK）、剂量面积乘积（dose area product, DAP）、住院时间、住院费用和并发症情况。HRQoL的评估基于术后第1天生活质量8条简明量表（8-item Short Form Health Survey, SF-8）。

结果

TRA组和TFA组的技术成功率均为100%，术中均未发生动脉入路转换。TRA组与TFA组相比，造影剂用量（67.1 ± 34.1 mL vs 67.0±36.2 mL, P = 0.973）、透视时间（15.7 [12.0–21.0] s vs 14.5[10.5–19.3] s, P = 0.185）、手术时间（55.0 [40.5–70.0] min vs 45.0 [40.0–61.0] min, P = 0.136）、AK（422.9 ± 292.7 mGy vs 448.2 ± 333.7 mGy, P = 0.647）、DAP（149.4 ± 104.2 Gy.cm² vs 187.4 ± 217.4 Gy.cm², P = 0.207）、住院时间（6 [4–7] 天 vs 6 [4–7] 天, P = 0.839）、住院费用（2.72 ± 0.48万元     vs 2.78 ± 0.66万元, P = 0.567）差异均无统计学意义。两组不良事件的发生率和严重程度也相似（P均> 0.05）。然而，与TFA组相比，TRA组从手术开始后1天内的总体不适程度（3.4 ± 2.2 vs 4.7 ± 2.0, P < 0.001）、上厕所困难程度（1.7 ± 1.0 vs 4.9 ± 1.4, P < 0.001）、饮食/自我照顾困难程度（1.8 ± 1.0 vs 2.6 ± 1.3, P < 0.001）、过去24小时内自由行走困难程度（1.3 ± 1.0 vs 5.1 ± 1.7, P < 0.001）均显著更低；同时，TRA组的总体健康评分（68.2 ± 20.0 vs 50.8 ± 17.0, P < 0.001）、躯体活动功能评分（86.2 ± 20.7 vs 63.9 ± 28.3, P < 0.001）、躯体功能对角色功能的影响评分（78.1 ± 24.8 vs 63.9 ± 28.3, P = 0.022）、社会功能评分（82.3 ± 17.5 vs 74.2 ± 23.0, P = 0.026）、心理功能评分（84.2 ± 17.4 vs 72.7 ± 25.3, P = 0.003）和情绪对角色功能的影响评分（83.1 ± 18.3 vs 67.3 ± 30.6, P = 0.001）均显著优于TFA组。因此，TRA组患者下一次手术更倾向于选择当前动脉入路的比例显著高于TFA组（90.8% vs 24.6%, P < 0.001）。

结论

（1）TRA相对于TFA可以促使HCC患者TACE治疗后更早地自由活动，术后舒适度和HRQoL评分显著提高。

（2）TRA相对于TFA不改变TACE治疗过程相关指标，包括造影剂用量、透视时间、手术时间、AK、DAP、住院时间和住院费用。

（3）TRA-TACE和TFA-TACE术后并发症的发生率和严重程度相似。

总的来说，TRA可以提高HCC患者TACE治疗后的满意度，同时不影响治疗过程相关指标并具有很好的安全性，可以作为TFA的替代入路。

中文摘要（第二部分）

经桡动脉入路TACE治疗肝细胞癌患者后穿刺点压迫止血方案：一项前瞻性观察性研究

研究背景与目的

经桡动脉入路（transradial access, TRA）介入术后最常见的穿刺部位并发症是桡动脉闭塞（radial artery occlusion, RAO），RAO的发生导致患者失去使用同一侧桡动脉再次进行介入手术的机会，严重影响患者后续介入手术动脉入路的选择和治疗策略的制定，影响TRA在外周介入的推广。穿刺部位压迫止血时间是影响RAO的重要因素，TRA外周介入领域尚无针对压迫止血时间的研究。本研究旨在通过前瞻性观察性研究探究TRA在肝细胞癌（hepatocellular carcinoma, HCC）患者中行经动脉化疗栓塞（transarterial chemoembolization, TACE）治疗后穿刺部位最短的压迫止血时间，同时评估对应的RAO和出血相关并发症的发生情况，并分析影响压迫止血时间的因素，最终制定合理的TRA外周介入术后穿刺部位压迫止血方案。

材料与方法

本研究是一项前瞻性观察性临床研究，从2019年10月至2021年10月，纳入在中国医学科学院肿瘤医院介入治疗科接受TACE治疗的HCC患者。主要观察指标为术后穿刺部位压迫止血时间，即从使用压迫器完成“通畅性止血”开始到完全拆除压迫器的时间。压迫时间的观察从完成“通畅性止血”后30min开始第1次观察，若已经完全止血则拆除压迫器，若未完全止血则每隔10分钟观察1次，直至完全止血并拆除压迫器。次要观察指标包括TACE技术成功率、动脉入路转换率、桡动脉直径、尝试穿刺次数、穿刺时间、手术时间、RAO和并发症情况。

结果

本研究共纳入119名HCC患者共行134例次TRA-TACE手术。TRA-TACE的技术成功率为100%，术中未发生动脉入路转换。大多数（83.6%）的TRA-TACE手术只需要1次穿刺就能成功完成桡动脉穿刺，平均穿刺时间为27.9 ± 25.6 s。术前平均桡动脉直径为2.7 ± 0.3 mm，术后24h平均桡动脉直径为2.8 ± 0.3 mm。所有患者均未出现TRA相关的严重并发症。轻微并发症的发生率为7.5%，包括6例（4.5%）穿刺点周围轻微疼痛，4例（3.0%）穿刺点周围青紫，2例（1.5%）穿刺点周围血肿和1例（0.7%）早期RAO。穿刺部位平均压迫止血时间为31.8 ± 5.0 min。117例（87.3%）TRA-TACE在压迫30min后即完成止血，所有TRA-TACE（n = 134）完成止血的压迫时间为60min。单因素和多因素逻辑回归分析提示血小板计数<100×10⁹ /L（P = 0.016, 比值比 = 3.942, 95%置信区间: 1.296–11.989）是压迫止血时间超过30min的独立危险因素。对于血小板计数<100×10⁹/L的患者（n = 45），34例（75.6%）TRA-TACE术后在压迫30min后完成止血，所有病例在压迫60min后完成止血；对于血小板计数≥100×10⁹ /L的患者（n = 89），83例（93.3%）TRA-TACE术后在压迫30min后完成止血，所有病例在压迫40min后完成止血。

结论

（1）“通畅性止血”方案对于接受TRA-TACE治疗的HCC患者是安全的。

（2）血小板计数<100×10⁹ /L是压迫止血时间超过30min的独立危险因素。

（3）对于接受TRA-TACE治疗的HCC患者来说，如果患者血小板计数<100×10⁹/L，穿刺部位压迫60min足够完成止血；如果患者血小板计数≥100×10⁹ /L，穿刺部位压迫40min就足够完成止血。

ABSTRACT (Part I)

Transradial versus transfemoral access for transarterial chemoembolization in patients with hepatocellular carcinoma: a randomized trial

Background and Objective

Transradial access (TRA) for cardiac interventions has been widely demonstrated for its patient preference, lower access site complications, and shorter hospital stay, however, it is unclear whether these advantages of TRA also apply in patients with hepatocellular carcinoma (HCC) undergoing transarterial chemoembolization (TACE). The purpose of this randomized trial was to compare patient satisfaction, procedural variables, and safety with TRA and transfemoral access (TFA) in patients undergoing TACE for HCC.

Materials and Methods

This is a prospective, randomized controlled clinical trial. From February 2019 to August 2021, 130 HCC patients who received initial TACE treatment at our institution were included, and patients were randomly assigned to the TRA group (n = 65) or the TFA group (n = 65) by random number method. The primary endpoint of this study was patient preference according to the post-catheterization questionnaire assessed 1 day after TACE. The secondary endpoints of this study were health-related quality of life (HRQoL), technical success rate, crossover rate, contrast agent dose, fluoroscopy time, procedure time, air kerma (AK), dose-area product (DAP), length of hospital stay (LoHS), total cost, and complications. HRQoL was assessed 1 day after TACE using the 8-item Short Form Health Survey (SF-8) (24-hour recall format).

Results

Technical success was achieved in all patients and therefore, the crossover rate was 0% in both groups. The contrast agent dose (67.1 ± 34.1 mL vs 67.0 ± 36.2 mL, P = 0.973), fluoroscopy time (15.7 [12.0–21.0] s vs 14.5 [10.5–19.3] s, P = 0.185), procedure time (55.0 [40.5–70.0] min vs 45.0 [40.0–61.0] min, P = 0.136), AK (422.9 ± 292.7 mGy vs 448.2 ± 333.7 mGy, P = 0.647), DAP (149.4 ± 104.2 Gy.cm² vs 187.4 ± 217.4 Gy.cm², P = 0.207), LoHS (6 [4–7] d vs 6 [4–7] d, P = 0.839), total cost (4260.7 ± 760.1 dollars vs 4352.1 ± 1034.0 dollars, P = 0.567) were not significantly different between the two groups. However, the mean score for overall discomfort since the procedure (3.4 ± 2.2 vs 4.7 ± 2.0, P < 0.001), difficulty going to the bathroom since the procedure (1.7 ± 1.0 vs 4.9 ± 1.4, P < 0.001), difficulty feeding or self-caring since the procedure (1.8 ± 1.0 vs 2.6 ± 1.3, P < 0.001), and difficulty walking in the last 24 hours (1.3 ± 1.0 vs 5.1 ± 1.7, P < 0.001) was significantly better in the TRA group than in the TFA group. Meanwhile, the mean score for general health (68.2 ± 20.0 vs 50.8 ± 17.0, P < 0.001), physical function (86.2 ± 20.7 vs 63.9 ± 28.3, P < 0.001), role physical function (78.1 ± 24.8 vs 63.9 ± 28.3, P = 0.022), social function (82.3 ± 17.5 vs 74.2 ± 23.0, P = 0.026), mental health (84.2 ± 17.4 vs 72.7 ± 25.3, P = 0.003), and role emotional function (83.1 ± 18.3 vs 67.3 ± 30.6, P = 0.001) was significantly better in the TRA group than in the TFA group. Consequently, more patients preferred the current access for their next procedure in the TRA group than in the TFA group (90.8% vs 24.6%, P < 0.001).

Conclusions

(1) TRA enabled early ambulation after TACE, resulting in significant increase in activities of daily living and HRQoL compared to TFA.

(2) Procedural variables (contrast agent dose, fluoroscopy time, procedure time, AK, DAP, length of hospital stay, and total cost) were not significantly different between patients who received TRA-TACE and TFA-TACE.

(3) The incidence and severity of adverse events were similar between patients who received TRA-TACE and TFA-TACE.

Therefore, in patients undergoing TACE for HCC, using TRA instead of TFA can improve patient satisfaction without compromising procedural variables and safety.

ABSTRACT (Part II)

To explore the optimal hemostasis strategy after transradial access chemoembolization in patients with hepatocellular carcinoma: a prospective observational study

Background and Objective

Radial artery occlusion (RAO) is the most frequent post-procedural access site-related complication of transradial access (TRA), restricting the use of the same radial artery for future interventional procedures, and seriously affecting the choice of arterial access and treatment strategy for subsequent interventions, as well as the promotion of TRA in peripheral interventions. RAO is affected by the duration of hemostatic compression, but no studies have been conducted in the field of peripheral interventions to address this issue. This prospective observational study aimed to investigate the duration of hemostatic compression after transradial access chemoembolization (TRA-TACE) in patients with hepatocellular carcinoma (HCC), the incidence of corresponding RAO and bleeding-related complications, and to analyze the factors affecting hemostasis time, and ultimately to devise an optimal hemostasis strategy after TRA peripheral interventions.

Materials and Methods

From October 2019 to October 2021, patients with HCC scheduled to receive TRA-TACE were included in this prospective observational study. The primary endpoint was the duration of hemostatic compression, which was defined as the time between achieving patent hemostasis using a compression device and complete removal of the compression device. The compression duration was measured by decompressing the device for 30 min, and thereafter, every 10 min after the procedure until complete hemostasis was achieved. The secondary endpoints included technical success, cross-over rate, radial artery diameter, number of puncture attempts, puncture time, procedure time, the incidence of RAO and other complications.

Results

This study enrolled 119 consecutive patients with HCC who underwent 134 sessions of TRA-TACE. Technical success was 100%, and none of the patients required conversion to the femoral artery or contralateral radial artery. For most TRA procedures (83.6%), one puncture attempt was sufficient to successfully establish radial artery access, the mean puncture time was 27.9 ± 25.6 s. The mean radial artery diameter was 2.7 ± 0.3 mm before the procedure and 2.8 ± 0.3 mm 24 h after the procedure. None of the patients experienced major TRA-related adverse events. Minor adverse events occurred in 7.5% of the patients, including pain (n = 6, 4.5%), ecchymosis (n = 4, 3.0%), hematoma (n = 2, 1.5%), and early RAO (n = 1, 0.7%). The mean duration of hemostatic compression was 31.8 ± 5.0 min. Successful initial hemostasis was achieved in 117 TRA procedures (87.3%) at 30 min after the procedure, and the compression time for all procedures to achieve hemostasis was 60 min. Factors that may impact hemostasis were analyzed in the univariate and multivariate analyses, and a platelet count < 100 × 10⁹ /L (P = 0.016, odds ratio = 3.942, 95% confidence interval: 1.296–11.989) was found to be the only independent factor that could predict the failure to achieve hemostasis within 30 min. For patients with a platelet count < 100 × 10⁹ /L, 34 of 45 (75.6%) TRA procedures achieved hemostasis at 30 min after the procedure; the time for all procedures to achieve hemostasis was 60 min. However, for patients with a platelet count ≥ 100 × 10⁹ /L, 83 of 89 (93.3%) TRA procedures achieved hemostasis at 30 min after the procedure; the time for all procedures to achieve hemostasis was 40 min.

Conclusions

(1) The patent hemostasis strategy was safe in HCC patients treated with TRA-TACE.

(2) Platelet count < 100 × 10⁹ /L was found to be an independent factor that could predict failure to achieve hemostasis within 30 min.

(3) To achieve hemostasis in HCC patients treated with TRA-TACE, compression for 60 min is sufficient for those with a platelet count < 100 × 10⁹ /L, and compression for 40 min is sufficient for those with a platelet count ≥ 100 × 10⁹ /L.