Reduction of Major Amputations after Surgery versus Endovascular Intervention: The BEST-CLI Randomised Trial.

OBJECTIVE: BEST-CLI, an international randomised trial, compared an initial strategy of bypass surgery with endovascular treatment in chronic limb threatening ischaemia (CLTI). In this substudy, overall amputation rates and risk of major amputation as an initial or subsequent outcome were evaluated. METHODS: A total of 1 830 patients were randomised to receive surgical or endovascular treatment in two parallel cohorts: patients with adequate single segment great saphenous vein (SSGSV) (n = 1 434) were assigned to cohort 1; and patients without adequate SSGSV (n = 396) were assigned to cohort 2. Differences in time to first event and number of amputations were evaluated. RESULTS: In cohort 1, there were 410 (45.6%) total amputation events in the surgical group vs. 490 (54.4%) in the endovascular group (p = .001) during a mean follow up of 2.7 years. Approximately one in three patients underwent minor amputation after index revascularisation: 31.5% of the surgical group vs. 34.9% in the endovascular group (p = .17). Subsequent major amputation was required significantly less often in the surgical group compared with the endovascular group (15.0% vs. 25.6%; p = .002). The first amputation was major in 5.6% of patients in the surgical group and 6.0% in the endovascular group (p = .72). Major amputation was required in 10.3% (74/718) of patients in the surgical group and 14.9% (107/716) in the endovascular group (p = .008). In cohort 2, there were 199 amputation events in 132 patients (33.3%) during a mean follow up of 1.6 years: 95 (47.7%) in the surgical group vs. 104 (52.3%) in the endovascular group (p = .49). Major amputation was required in 15.2% (30/197) of patients in the surgical group and 14.1% (28/199) in the endovascular group (p = .74). CONCLUSION: In patients with CLTI, surgical bypass with SSGSV was more effective than endovascular treatment in preventing major amputations, mainly due to a decrease in major amputations subsequent to minor amputations.

Effect of triclosan-coated sutures on the incidence of surgical wound infection after lower limb revascularization surgery: a randomized controlled trial.

BACKGROUND: Surgical wound infection (SWI) is a common complication after peripheral vascular surgery. In a prospective study, triclosan-coated sutures were reported to decrease the incidence of surgical site infection after various surgical procedures. The aim of our study was to test the hypothesis that use of triclosan-coated sutures decreases the incidence of SWI after lower limb vascular surgery. METHODS: This prospective, randomized, multicenter, double-blinded trial was conducted between July 2010 and January 2011 in five hospitals in Finland. We randomly allocated 276 patients undergoing lower limb revascularization surgery to a study (n = 139) or a control (n = 137) group. Surgical wounds in the study group were closed with triclosan-coated suture material, and wounds in the control group were closed with noncoated sutures. The main outcome measure was SWI. A surgical wound complication was considered to be an infection if there were bacteria isolated from the wound or if there were areas of localized redness, heat, swelling, and pain around the wound appearing within 30 days after the operative procedure. Logistic regression analysis was used to assess the independent effect of triclosan-coated sutures on the incidence of SWI. RESULTS: Altogether, 61 (22.1 %) patients developed SWI. SWI occurred in 31 (22.3 %) patients in the study group and in 30 (21.9 %) patients in the control group (odds ratio 1.10, 95% confidence interval 0.61-2.01, p = 0.75.) CONCLUSIONS: The use of triclosan-coated sutures does not reduce the incidence of SWI after lower limb vascular surgery.

EVAR may reduce the risk of aneurysm rupture despite persisting type Ia endoleaks.

PURPOSE: To determine the risk of aneurysm rupture in patients with persisting proximal type Ia endoleaks following endovascular aneurysm repair (EVAR) in comparison to the risk of rupture of untreated abdominal aortic aneurysms (AAA) of similar size. METHODS: Among 400 patients who where treated with EVAR from 1996 to 2003 at a single center, 21 (5.3%) patients (13 men; mean age 78.0±5.0 years, range 67-86) with large (≥5.5 cm) aneurysms had imaging evidence of type Ia endoleaks that persisted >10 months (type Ia group) despite secondary endovascular treatment. These patients were compared to 24 untreated AAA patients (17 men; mean age 73.8±5.2 years, range 64-88) with large aneurysms from a separate geographic region with a well-established aneurysm treatment program before EVAR became available (1990-1998). RESULTS: There were no significant differences between the type Ia and the untreated AAA patients with regard to age (79±8 vs. 74±5 years), gender (38% vs. 29% women), baseline aneurysm diameter (6.1±0.7 vs. 6.4±0.9 cm), or length of follow-up (32±23 vs. 29±40 months). During the follow-up period, the rate of aneurysm enlargement was significantly lower in type Ia patients (0.19 cm/y) than in untreated AAA patients (0.54 cm/y, p = 0.03). One (4.8%) patient with a persisting type Ia endoleak and 2-cm aneurysm enlargement (0.8 cm/y) had aneurysm rupture after 2.5 years, while 12 (50%) of the 24 untreated aneurysms ruptured (p = 0.001), which was the primary cause of death in this group. The rupture rate was 1.8 per 100 patient-years in the type Ia group and 20.7 per 100 patient-years in the untreated AAA group. Aneurysm-related mortality was significantly reduced in the type Ia group compared to the untreated AAA group at 36 months (11% vs. 52%, p = 0.004). In the multivariate analysis, factors associated with death were an untreated AAA (odds ratio 97, p = 0.004), female gender (odds ratio 9.7, p = 0.02), and baseline aneurysm size (odds ratio 4.7/cm, p = 0.03). CONCLUSION: This study suggests that EVAR may reduce the risk of rupture and aneurysm-related death despite the presence of a persisting type Ia endoleak. This finding is limited to patients with aortic endografts that are in good position. The mechanism of protection from rupture is unclear but may be related to reducing the rate of aneurysm enlargement.

Infrapopliteal percutaneous transluminal angioplasty versus bypass surgery as first-line strategies in critical leg ischemia: a propensity score analysis.

INTRODUCTION: Recently, endovascular revascularization (percutaneous transluminal angioplasty [PTA]) has challenged surgery as a method for the salvage of critically ischemic legs (CLI). Comparison of surgical and endovascular techniques in randomized controlled trials is difficult because of differences in patient characteristics. To overcome this problem, we adjusted the differences by using propensity score analysis. MATERIALS AND METHODS: The study cohort comprised 1023 patients treated for CLI with 262 endovascular and 761 surgical revascularization procedures to their crural or pedal arteries. A propensity score was used for adjustment in multivariable analysis, for stratification, and for one-to-one matching. RESULTS: In the overall series, PTA and bypass surgery achieved similar 5-year leg salvage (75.3% vs 76.0%), survival (47.5% vs 43.3%), and amputation-free survival (37.7% vs 37.3%) rates and similar freedom from any further revascularization (77.3% vs 74.4%), whereas freedom from surgical revascularization was higher after bypass surgery (94.3% vs 86.2%, P < 0.001). In propensity-score-matched pairs, outcomes did not differ, except for freedom from surgical revascularization, which was significantly higher in the bypass surgery group (91.4% vs 85.3% at 5 years, P = 0.045). In a subgroup of patients who underwent isolated infrapopliteal revascularization, PTA was associated with better leg salvage (75.5% vs 68.0%, P = 0.042) and somewhat lower freedom from surgical revascularization (78.8% vs 85.2%, P = 0.17). This significant difference in the leg salvage rate was also observed after adjustment for propensity score (P = 0.044), but not in propensity-score-matched pairs (P = 0.12). CONCLUSIONS: When feasible, infrapopliteal PTA as a first-line strategy is expected to achieve similar long-term results to bypass surgery in CLI when redo surgery is actively utilized.