Lymphedema Duration on Lymphatic Vessel Quality and Outcomes After LVA (LVA)

The Impact of Surgical Intervention on Lymphatic System in Patients With Lymphedema

This study aimed to address the impact of lymphedema duration on the quality of lymphatic vessels as well as the outcome after LVA using propensity score matching.

Study Overview

• Status: Completed
• Conditions: Lymphedema
• Intervention / Treatment: Procedure: lymphaticovenous anastomosis

Detailed Description

With an increase in the incidence and treatment of breast and gynecological cancers, an increase in the prevalence of secondary lymphedema has been witnessed1. As a consequence of lymphadenectomy and adjuvant radiotherapy, swollen limbs result from the accumulation of protein rich fluid2. Lymphedema is predicted to arise in 20-40% of patients with cervical and breast cancer3, which is a chronic disease that can significantly hamper quality of life4-6. Affected limbs may suffer from lifelong swelling with functional impairment and repeated cellulitis, and some may eventually progress to late-stage diseases such as elephantiasis and lymphorrhea7-9.

Supermicrosurgical lymphaticovenous anastomosis (LVA) is a well-documented minimally invasive treatment modality that bypasses lymph into the venous system to alleviate lymphedema10-14. It was a common belief that a longer lymphedema duration (LD) may be associated with inferior lymphatic vessel (LVs) quality, as well as excess fibrous components in the affected limbs, which are characteristics of advanced lymphedema. Consequently, owing to inferior LV quality, LVA is considered unsuitable for advanced cases; instead, vascularized lymph node transfer (VLNT) or excisional procedures are recommended7,15.

However, growing evidence has demonstrated the effectiveness of LVA for the treatment of severe lymphedema16-19. These findings, contrary to common beliefs, raise questions regarding the association between LD, LV quality, and outcomes after LVA. This study aimed to address the impact of LD on the quality of LV as well as the outcome after LVA using propensity score matching.

• Study Type: Observational
• Enrollment (Actual): 189

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Probability Sample

Study Population

All adult patients (age >20 years) receiving LVA for lower limb lymphedema at a tertiary medical center were retrospectively reviewed from September 2015 to March 2023.

Description

Inclusion Criteria:

• This study including patients diagnosed with lymphatic-related diseases at Kaohsiung Chang Gung Memorial Hospital from September 2015 to March 2023.

Patients who underwent LVA for unilateral lower-limb lymphedema.

Exclusion Criteria:

• Primary lymphedema, bilateral lower limb lymphedema, history of previous LVA, vascularized lymph node transfer (VLNT), liposuction, or excisional therapy such as the Charles procedure, and those that were lost to follow-up.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Lymphedema duration > 3.6 years	Procedure: lymphaticovenous anastomosis; The patients were under intravenous general anesthesia with local anesthetic infiltration for each incision21. LVs were detected by intradermal injection of ICG into the web spaces between the toes and on the medial and lateral malleoli. ICG flow with linear dermal backflow(DB) patterns was detected immediately using a handheld near-infrared camera. The recipient veins were marked using B-mode echo Doppler, close to the marked linear pattern. In case of DB pattern, the incision was made along the great saphenous vein. A 3 cm incision was made and the lymphatics and recipient veins were identified. All patients underwent supermicrosurgical LVA with 11- 0 nylon sutures using a high-power surgical microscope by a single senior surgeon. LVAs are performed using only antegrade flow lymphatics and lymphaticovenous end-to-end anastomosis (LVEEA) and end-to-side anastomosis (LVESA).
Lymphedema duration ≤ 3.6 years	Procedure: lymphaticovenous anastomosis; The patients were under intravenous general anesthesia with local anesthetic infiltration for each incision21. LVs were detected by intradermal injection of ICG into the web spaces between the toes and on the medial and lateral malleoli. ICG flow with linear dermal backflow(DB) patterns was detected immediately using a handheld near-infrared camera. The recipient veins were marked using B-mode echo Doppler, close to the marked linear pattern. In case of DB pattern, the incision was made along the great saphenous vein. A 3 cm incision was made and the lymphatics and recipient veins were identified. All patients underwent supermicrosurgical LVA with 11- 0 nylon sutures using a high-power surgical microscope by a single senior surgeon. LVAs are performed using only antegrade flow lymphatics and lymphaticovenous end-to-end anastomosis (LVEEA) and end-to-side anastomosis (LVESA).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Volume change after LVA.	The primary endpoint was the volume change at 6/12 months after LVA.	6/12 months

Collaborators and Investigators

• Sponsor: Chang Gung Memorial Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2015
• Primary Completion (Actual): March 1, 2023
• Study Completion (Actual): March 1, 2023

Study Registration Dates

• First Submitted: March 15, 2024
• First Submitted That Met QC Criteria: March 15, 2024
• First Posted (Actual): March 21, 2024

Study Record Updates

• Last Update Posted (Actual): March 21, 2024
• Last Update Submitted That Met QC Criteria: March 15, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: retrospective cohort
• Additional Relevant MeSH Terms: Lymphatic Diseases; Lymphedema
• Other Study ID Numbers: 202400221B0

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No