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A prospective safety and effectiveness study using endovenous laser ablation with a 400-µm optical fiber for the treatment of pathologic perforator veins in patients with advanced venous disease (SeCure trial).
Gibson, Kathleen; Elias, Steven; Adelman, Mark; Hager, Eric S; Dexter, David J; Vayuvegula, Sathish; Chopra, Paramjit; Kabnick, Lowell S.
Afiliação
  • Gibson K; Lake Washington Vascular, Bellevue, Wash. Electronic address: dr.gibson@lkwv.com.
  • Elias S; Englewood Hospital and Medical Center, Englewood, NJ.
  • Adelman M; NYU Vein Center, New York, NY.
  • Hager ES; University of Pittsburgh Medical Center, Pittsburgh, Pa.
  • Dexter DJ; Vein Center of Virginia, Virginia Beach, Va.
  • Vayuvegula S; Vein Clinics of America, Orlando Park, Ill.
  • Chopra P; The Midwest Institute for Minimally Invasive Therapies, Melrose Park, Ill.
  • Kabnick LS; Kabnick Vein Center, Morristown, NJ.
J Vasc Surg Venous Lymphat Disord ; 8(5): 805-813, 2020 09.
Article em En | MEDLINE | ID: mdl-32205128
ABSTRACT

BACKGROUND:

Treatment of pathologic perforator veins (PPVs) can shorten time to healing and reduce recurrence of ulcers in patients with advanced venous disease. Because of limited clinical evidence and device options, widespread adoption of PPV treatment is controversial. The objective of this study was to evaluate the safety and efficacy of endovenous laser therapy using a 400-µm optical fiber to treat PPVs.

METHODS:

This study was a single-arm, prospective, seven-center, nonblinded clinical study examining patients with advanced skin changes or healed or active ulceration (Clinical, Etiology, Anatomy, and Pathophysiology clinical class C4b, C5, and C6). Patients received treatment with a 1470-nm laser. Procedural technical success and 10-day primary closure were evaluated. All device-related adverse events were reported. Follow-up of patients was continued for 12 months after initial ablation.

RESULTS:

The primary PPV closure (at 10-day visit) rate was 76.9% (95% confidence interval, 70.3%-82.4%). Successful primary closure rates of 75.7%, 70.3%, 62.1%, 68.8%, and 71.3% of PPVs were achieved at 1 month, 3 months, 6 months, 9 months, and 12 months, respectively. Statistically significant improvements (P < .05) were seen in patients' quality of life at 1 month, 3 months, 6 months, 9 months, and 12 months compared with screening. The percentage of patients with ulcers (22.9% at screening, 14.1% at 1 month, 13.7% at 3 months, 10.1% at 6 months, 12.3% at 9 months, and 11.1% at 12 months) displayed improvement during the course of the study. Tibial deep venous thrombosis and procedural pain were the only device-related adverse events observed.

CONCLUSIONS:

Endovenous laser therapy for PPV using the 400-µm optical fiber with the 1470-nm laser yielded safe and effective outcomes with no major adverse sequelae.
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Texto completo: 1 Base de dados: MEDLINE Assunto principal: Úlcera Varicosa / Veias / Insuficiência Venosa / Terapia a Laser / Fibras Ópticas / Procedimentos Endovasculares Idioma: En Ano de publicação: 2020 Tipo de documento: Article

Texto completo: 1 Base de dados: MEDLINE Assunto principal: Úlcera Varicosa / Veias / Insuficiência Venosa / Terapia a Laser / Fibras Ópticas / Procedimentos Endovasculares Idioma: En Ano de publicação: 2020 Tipo de documento: Article