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Published on: February 10, 2023
Comparison of outcomes of percutaneous deep venous arterialization in multiple practice settings
Neginder Saini1, Laura Marrone2, Sanket Desai3
1Zucker School of Medicine at Hofstra/Northwell Health, Manhasset, NY.
Insights
Percutaneous deep venous arterialization (pDVA) is a safe and effective treatment for chronic limb-threatening ischemia. Outcomes were similar whether the procedure was performed in a hospital or an office-based laboratory setting.
Area of Science:
- Vascular Surgery
- Interventional Cardiology
- Endovascular Procedures
Background:
- Chronic limb-threatening ischemia (CLTI) poses a significant challenge, particularly for patients deemed unsuitable for conventional revascularization.
- Percutaneous deep venous arterialization (pDVA) offers a potential solution for "no-option" CLTI patients by creating an arterialized venous system.
Purpose of the Study:
- To compare the efficacy and safety of pDVA performed in a hospital setting versus an office-based laboratory (OBL).
- To evaluate key outcomes including major amputation-free survival, limb salvage, and wound healing rates.
Main Methods:
- A retrospective chart review of 73 patients with Rutherford classification IV or higher CLTI who underwent pDVA between January 2018 and March 2023.
- Patients were stratified into two groups: hospital-based pDVA (n=41) and OBL-based pDVA (n=32).
- Outcomes were assessed using Kaplan-Meier analysis, comparing major amputation-free survival, technical success, limb salvage, patency, wound healing, and adverse events.
Main Results:
- Technical success was high in both settings (96% overall).
- While OBL showed numerically higher amputation-free survival and wound healing rates at 6 months and 1 year, these differences were not statistically significant at 2 years.
- No significant differences were observed between hospital and OBL settings for major amputation-free survival (P=.13), limb salvage (P=.07), or wound healing (P=.08 and P=.79 for partial and complete, respectively).
Conclusions:
- pDVA is a feasible and safe endovascular option for patients with no-option critical limb ischemia.
- The procedure demonstrates comparable outcomes when performed in either a hospital or an office-based laboratory setting up to two years post-intervention.
- These findings support the expansion of pDVA as a viable limb salvage strategy in diverse clinical environments.
Objective:
We compared the efficacy of percutaneous deep venous arterialization (pDVA) in patients with no-option chronic limb-threatening ischemia in the hospital vs in office-based laboratory (OBL) settings.
Methods:
A retrospective chart review was performed of all patients who underwent pDVA using off-the-shelf devices from January 2018 to March 2023 in a hospital and an OBL. We identified 73 eligible patients, 41 from a hospital setting (59% male; median age, 72 years; interquartile range, 18 years) and 32 from an OBL setting (59% males; 67 years; interquartile range, 16 years). All eligible patients were deemed to have no-option critical limb ischemia, had at least one patent proximal tibial artery available for the creation of an arteriovenous anastomosis, and were classified as having Rutherford classification IV or higher peripheral arterial disease. Patients were ineligible if classified as Rutherford classification III or lower, had active infection, did not have at least one appropriate venous target, and/or had rapidly progressing wounds requiring immediate major amputation. The primary outcome was major amputation-free survival (AFS). Secondary outcomes included technical success, limb salvage, survival, primary patency, reintervention rate, adverse events, and partial and complete wound healing. Outcomes were evaluated using Kaplan-Meier method, log-rank, and two-stage procedure tests.
Results:
Technical success was achieved in 70 patients (96%) with 1 hospital (2.4%) and 2 OBL (6.3%) patients lost to follow-up. Major AFS estimates at 6 months, 1 year, and 2 years were 51.4%, 40.4%, and 30.2% in the hospital group and 69.4%, 54.0%, and 49.5% in the OBL group, respectively. Partial wound healing estimates at 6 months, 1 year, and 2 years were 27.5%, 71.7%, and 81.2% in the hospital group and 62.7% at all time points in the OBL group. Complete wound healing estimates at 6 months, 1 year, and 2 years were 6.7%, 33.3%, and 33.3% in the hospital group and 5.3%, 37.7%, and 41.6% in the OBL group, respectively. There was no significant difference in major AFS (P = .13), limb salvage (P = .07), survival (P = .69), primary patency (P = .53), partial (P = .08), or complete wound healing (P = .79) between groups. Reintervention was performed in 8 hospital (20.5%) and 14 OBL (45.2%) patients.
Conclusions:
pDVA is a feasible and safe procedure for no-option critical limb ischemia in the hospital and OBL setting without significant differences in outcomes at ≤2 years.
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