目的:腔内消融是有症状的浅表静脉功能不全患者的标准治疗方法。对于有深静脉血栓形成(DVT)病史的患者,人们担心术后并发症的风险增加,特别是静脉血栓栓塞症(VTE)。这项研究的目的是评估有DVT病史的患者的静脉内热消融的安全性和有效性。
方法:国家血管质量倡议(VQI)静脉曲张登记(VVR)于2014年1月至2021年7月进行了浅静脉手术。在有和没有DVT病史的患者之间比较了射频或激光消融治疗的肢体。主要安全终点是在<3个月随访时,在治疗肢体中发生DVT或吸热热诱导的血栓形成(EHIT)II-IV。次要安全终点包括任何近端血栓延伸(即,EHITI-IV),大出血,血肿,肺栓塞(PE),并因手术而死亡。主要疗效终点是技术失败(即,在<1周随访时再通)。次要疗效终点包括一段时间内再通的风险和术后生活质量指标的变化。术前使用抗凝(AC)的结果也与先前DVT的患者进行了比较。
结果:在对23,572名年龄在13-90岁的个体患者进行的33,892例腔内热消融中,有1,698例患者(7.2%)有DVT病史。既往DVT患者年龄较大(p<0.001),较高的BMI(p<0.001),出生时更可能是男性(p<0.001)和黑人/非裔美国人(p<0.001),并有更高的CEAP分类(p<0.001)。DVT病史赋予新的DVT风险较高(1.4%vs.0.8%,p=0.03),近端血栓延伸(2.3%vs.1.6%,p=0.045),和出血(0.2%vs.0.04%,p=0.03)。EHITII-IV,PE,DVT病史和血肿风险没有差异(p=NS)。两组均无治疗死亡。在先前DVT的患者中继续进行术前AC并没有改变腔内消融后任何并发症的风险(p=NS),但在所有腔内热消融和手术中确实增加了血肿风险(p=0.001)。组间的技术故障相似(2.0%vs.1.2%,p=0.07),尽管DVT病史会随时间增加再通风险(HR=1.90,95%CI[1.46,2.46]),p<0.001)。各组在术后VCSS/HASTI评分方面具有相当的改善(p=NS)。
结论:对有DVT病史的患者进行静脉内热消融是有效的。然而,关于DVT风险升高的适当患者咨询,尽管仍然很低,是至关重要的。术前继续或保留AC的决定应根据具体情况而定。
OBJECTIVE: Endovenous ablation is the standard of care for patients with symptomatic superficial venous insufficiency. For patients with a history of deep vein thrombosis (DVT), concern exists for an increased risk of postprocedural complications, particularly venous thromboembolism. The objective of this study was to evaluate the safety and efficacy of endovenous thermal ablation in patients with a history of DVT.
METHODS: The national Vascular Quality Initiative Varicose Vein Registry was queried for superficial venous procedures performed from January 2014 to July 2021. Limbs treated with radiofrequency or laser ablation were compared between patients with and without a DVT history. The primary safety end point was incident DVT or endothermal heat-induced thrombosis (EHIT) II-IV in the treated limb at <3 months of follow-up. The secondary safety end points included any proximal thrombus extension (ie, EHIT I-IV), major bleeding, hematoma, pulmonary embolism, and death due to the procedure. The primary efficacy end point was technical failure (ie, recanalization at <1 week of follow-up). Secondary efficacy end points included the risk of recanalization over time and the postprocedural change in quality-of-life measures. Outcomes stratified by preoperative use of anticoagulation (AC) were also compared among those with prior DVT.
RESULTS: Among 33,892 endovenous thermal ablations performed on 23,572 individual patients aged 13 to 90 years, 1698 patients (7.2%) had a history of DVT. Patients with prior DVT were older (P < .001), had a higher body mass index (P < .001), were more likely to be male at birth (P < .001) and Black/African American (P < .001), and had greater CEAP classifications (P < .001). A history of DVT conferred a higher risk of new DVT (1.4% vs 0.8%; P = .03), proximal thrombus extension (2.3% vs 1.6%; P = .045), and bleeding (0.2% vs 0.04%; P = .03). EHIT II-IV, pulmonary embolism, and hematoma risk did not differ by DVT history (P = NS). No deaths from treatment occurred in either group. Continuing preoperative AC in patients with prior DVT did not change the risk of any complications after endovenous ablation (P = NS) but did confer an increased hematoma risk among all endovenous thermal ablations and surgeries (P = .001). Technical failure was similar between groups (2.0% vs 1.2%; P = .07), although a history of DVT conferred an increased recanalization risk over time (hazard ratio, 1.90; 95% confidence interval, 1.46, 2.46; P < .001). The groups had comparable improvements in postprocedural venous clinical severity scores and Heaviness, Aching, Swelling, Throbbing, and Itching scores (P = NS).
CONCLUSIONS: Endovenous thermal ablation for patients with a history of DVT was effective. However, appropriate patient counseling regarding a heightened DVT risk, albeit still low, is critical. The decision to continue or withhold AC preoperatively should be tailored on a case-by-case basis.