A new "closed" in situ vein bypass technique results in a reduced wound complication rate.
rct · Level II
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Abstract
This prospective randomised multicentre trial was conducted to test whether a new "closed" technique for in situ vein bypass would result in a lower frequency of wound complications, without negative effects on patency rates and without an intolerable increase in residual arteriovenous fistulae compared to the conventional "open" technique. We have developed a new "closed" technique using a co-axial catheter embolisation system for intra-operative coil embolisation of side branches, in order to avoid long incisions. In four centres and 95 patients, 97 in situ bypasses were performed: 47 "closed" and 50 "open". Randomisation was stratified for below knee femoropopliteal bypasses (60) and femorocrural bypasses (37). Indications were disabling intermittent claudication (29), restpain (26) or ulcers and/or necrosis (42). Postoperative mortality was 2% (one in the "closed", one in the "open" group). A total number of 16 (34%) wound complications (grade 1, 2 and 3) occurred in the closed group compared to 36 (72%) in the open group (p < 0.05). Deep wound complications (grade 2) occurred in six patients (13%) of the "closed" group, compared to 15 (30%) in the "open" group. In both groups, three patients (6%) developed deep wound complications including the bypass area (grade 3). In the "closed" group, 20 patients needed additional treatment for arteriovenous fistulae, compared to four in the "open" group. One-year patency rates did not show a statistically significant difference: primary patency rates were 65% and 61% and secondary patency rates were 86% and 76% respectively for the "closed" and "open" group. These results indicate that a "closed" technique reduces wound complication rate, without negative effects on the short term patency rates. The "closed" technique results in an increased number of postoperative treatments for residual arteriovenous fistulae.
Medical subject headings
- Arterial Occlusive Diseases
- Femoral Artery
- Postoperative Complications
- Saphenous Vein