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Safety and Efficacy of Endovenous Ablation in Patients with a History of Deep Venous Thrombosis.
OBJECTIVE: Endovenous ablation is the standard of care for patients with symptomatic superficial venous insufficiency. For patients with a history of deep venous thrombosis (DVT), there is concern for an increased risk of post-procedural complications, particularly venous thromboembolism (VTE). 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 (VQI) Varicose Vein Registry (VVR) was queried for superficial venous procedures performed from January 2014-July 2021. Limbs treated with radiofrequency or laser ablation were compared between patients with and without a DVT history. The primary safety endpoint was incident DVT or endothermal heat-induced thrombosis (EHIT) II-IV in the treated limb at <3-month follow-up. Secondary safety endpoints included any proximal thrombus extension (i.e., EHIT I-IV), major bleeding, hematoma, pulmonary embolism (PE), and death due to the procedure. The primary efficacy endpoint was technical failure (i.e., recanalization at <1-week follow-up). Secondary efficacy endpoints included the risk of recanalization over time and the post-procedural change in quality-of-life measures. Outcomes by pre-operative 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 13-90, 1,698 patients (7.2%) had a history of DVT. Patients with prior DVT were older (p<0.001), of higher BMI (p<0.001), more likely to be male at birth (p<0.001) and black/African American (p<0.001), and had greater CEAP classifications (p<0.001). A history of DVT conferred higher risk of new DVT (1.4% vs. 0.8%, p=0.03), proximal thrombus extension (2.3% vs. 1.6%, p=0.045), and bleeding (0.2% vs. 0.04%, p=0.03). EHIT II-IV, PE, and hematoma risk did not differ by DVT history (p=NS). No deaths from treatment occurred in either group. Continuing pre-operative AC in patients with prior DVT did not change the risk of any complications after endovenous ablation (p=NS) but did confer increased hematoma risk among all endovenous thermal ablations and surgeries (p=0.001). Technical failure was similar between groups (2.0% vs. 1.2%, p=0.07), though a history of DVT conferred increased recanalization risk over time (HR=1.90, 95% CI [1.46, 2.46]), p<0.001). Groups had comparable improvement in post-procedural VCSS/HASTI scores (p=NS).
CONCLUSIONS: Endovenous thermal ablation in 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 pre-operatively should be tailored on a case-by-case basis.
METHODS: The national Vascular Quality Initiative (VQI) Varicose Vein Registry (VVR) was queried for superficial venous procedures performed from January 2014-July 2021. Limbs treated with radiofrequency or laser ablation were compared between patients with and without a DVT history. The primary safety endpoint was incident DVT or endothermal heat-induced thrombosis (EHIT) II-IV in the treated limb at <3-month follow-up. Secondary safety endpoints included any proximal thrombus extension (i.e., EHIT I-IV), major bleeding, hematoma, pulmonary embolism (PE), and death due to the procedure. The primary efficacy endpoint was technical failure (i.e., recanalization at <1-week follow-up). Secondary efficacy endpoints included the risk of recanalization over time and the post-procedural change in quality-of-life measures. Outcomes by pre-operative 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 13-90, 1,698 patients (7.2%) had a history of DVT. Patients with prior DVT were older (p<0.001), of higher BMI (p<0.001), more likely to be male at birth (p<0.001) and black/African American (p<0.001), and had greater CEAP classifications (p<0.001). A history of DVT conferred higher risk of new DVT (1.4% vs. 0.8%, p=0.03), proximal thrombus extension (2.3% vs. 1.6%, p=0.045), and bleeding (0.2% vs. 0.04%, p=0.03). EHIT II-IV, PE, and hematoma risk did not differ by DVT history (p=NS). No deaths from treatment occurred in either group. Continuing pre-operative AC in patients with prior DVT did not change the risk of any complications after endovenous ablation (p=NS) but did confer increased hematoma risk among all endovenous thermal ablations and surgeries (p=0.001). Technical failure was similar between groups (2.0% vs. 1.2%, p=0.07), though a history of DVT conferred increased recanalization risk over time (HR=1.90, 95% CI [1.46, 2.46]), p<0.001). Groups had comparable improvement in post-procedural VCSS/HASTI scores (p=NS).
CONCLUSIONS: Endovenous thermal ablation in 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 pre-operatively should be tailored on a case-by-case basis.
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