Factors associated with lack of clinical improvement after vein ablation in the vascular quality initiative

Paula Pinto Rodríguez; Michael Fassler; Andrea Obi; Nicholas H Osborne; Scott T Robinson; Benjamin N Jacobs; Faisal Aziz; Khanh P Nguyen; Adam M Gwozdz; Limael E Rodriguez; Eri Fukaya; Ulka Sachdev; Cassius Iyad Ochoa Chaar; Research Committee of the American Venous Forum

doi:10.1016/j.jvsv.2024.101884

Factors associated with lack of clinical improvement after vein ablation in the vascular quality initiative

J Vasc Surg Venous Lymphat Disord. 2024 Mar 27:101884. doi: 10.1016/j.jvsv.2024.101884. Online ahead of print.

Affiliations

¹ Division of Vascular Surgery and Endovascular Therapy, Yale School of Medicine, New Haven, CT. Electronic address: paula.pintorodriguez@yale.edu.
² Division of Vascular Surgery and Endovascular Therapy, University of Florida College of Medicine, Gainesville, FL.
³ Division of Vascular Surgery, University of Michigan, Ann Arbor, MI.
⁴ Division of Vascular Surgery, Penn State Heart and Vascular Institute, Pennsylvania State University College of Medicine, Hershey, PA.
⁵ Division of Vascular Surgery, Knight Cardiovascular Institute, Oregon Health & Science University, Portland, OR.
⁶ Section of Vascular Surgery, Department of Surgery and Cancer, Imperial College London, London, UK; Imperial Vascular Unit, Imperial College Healthcare NHS Trust, London, UK.
⁷ Division of Vascular Surgery, Texas Vascular and Imaging, Houston, TX.
⁸ Division of Vascular Surgery, Stanford University School of Medicine, Stanford, CA.
⁹ Division of Vascular Surgery, University of Pittsburgh Medical Center, Pittsburgh, PA.
¹⁰ Division of Vascular Surgery and Endovascular Therapy, Yale School of Medicine, New Haven, CT.

PMID: 38552954
DOI: 10.1016/j.jvsv.2024.101884

Abstract

Background: Insurance companies have adopted variable and inconsistent approval criteria for chronic venous disease (CVD) treatment. Although vein ablation (VA) is accepted as the standard of care for venous ulcers, the treatment criteria for patients with milder forms of CVD remain controversial. This study aims to identify factors associated with a lack of clinical improvement (LCI) in patients with less severe CVD without ulceration undergoing VA to improve patient selection for treatment.

Methods: We performed a retrospective analysis of patients undergoing VA for CEAP C2 to C4 disease in the Vascular Quality Initiative varicose veins database from 2014 to 2023. Patients who required intervention in multiple veins, had undergone prior interventions, or presented with CEAP C5 to C6 disease were excluded. The difference (Δ) in venous clinical severity score (VCSS; VCSS before minus after the procedure) was used to categorize the patients. Patients with a ΔVCSS of ≤0 were defined as having LCI after VA, and patients with ≥1 point decrease in the VCSS after VA (ΔVCSS ≥1) as having some benefit from the procedure and, therefore, "clinical improvement." The characteristics of both groups were compared, and multivariable regression analysis was performed to identify factors independently associated with LCI. A second analysis was performed based on the VVSymQ instrument, which measures patient-reported outcomes using five specific symptoms (ie, heaviness, achiness, swelling, throbbing pain, and itching). Patients with LCI showed no improvement in any of the five symptoms, and those with clinical improvement had a decrease in severity of at least one symptom.

Results: A total of 3544 patients underwent initial treatment of CVD with a single VA. Of the 3544 patients, 2607 had VCSSs available before and after VA, and 420 (16.1%) had LCI based on the ΔVCSS. Patients with LCI were more likely to be significantly older and African American and have CEAP C2 disease compared with patients with clinical improvement. Patients with clinical improvement were more likely to have reported using compression stockings before treatment. The vein diameters were not different between the two groups. The incidence of complications was overall low, with minor differences between the two groups. However, the patients with LCI were significantly more likely to have symptoms after intervention than those with improvement. Patients with LCI were more likely to have technical failure, defined as vein recanalization. On multivariable regression, age (odds ratio [OR], 1.01; 95% confidence interval [CI], 1.00-1.02) and obesity (OR, 1.47; 95% CI, 1.09-2.00) were independently associated with LCI, as was treatment of less severe disease (CEAP C2; OR, 1.82; 95% CI, 1.30-2.56) compared with more advanced disease (C4). The lack of compression therapy before intervention was also associated with LCI (OR, 6.05; 95% CI, 4.30-8.56). The analysis based on the VVSymQ showed similar results.

Conclusions: LCI after VA is associated with treating patients with a lower CEAP class (C2 vs C4) and a lack of compression therapy before intervention. Importantly, no significant association between vein size and clinical improvement was observed.

Keywords: Chronic venous disease; Clinical effectiveness; Quality of care; Venous ablation.