Lower Extremity Amputation Rates in People With Diabetes Mellitus: A Retrospective Population Based Cohort Study in Zwolle Region, The Netherlands.

OBJECTIVE: Lower extremity amputations are a major complication of diabetes mellitus (DM). In a previous Dutch study, the incident rate of major amputations was 89.2 per 100 000 person years. The primary aim of this study was to describe the lower extremity amputation rates in people with DM in the Zwolle region, where preventive and curative footcare is organised according to the guidelines of the International Working Group of the Diabetic Foot (IWGDF). The secondary aim was to evaluate outcomes and underlying characteristics of these people. METHODS: This was a retrospective regional population based cohort study. Data from all people with DM treated in primary and secondary care, living in the region Zwolle were collected. All amputations in the period 2017 to 2019 were analysed. Comparisons were made between those with and without an amputation. RESULTS: In the analysis 5 915 people with DM were included, with a mean age of 67.8 (IQR 57.9, 75.9) years. Of those people, 47% were women and the median HbA1c was 53 (IQR 47, 62) mmol/mol. Over the three year study period 68 amputations were performed in 59 people: 46 minor, 22 major. This translated into an average annual crude amputation incidence rate of non-traumatic major and minor amputations of 41.5 and 86.9 per 100 000 person years among people with diabetes. Compared with those not undergoing amputations, those who underwent an amputation were more often men, older, mainly had T2DM, were treated in secondary care, had higher diastolic blood pressure, worse diabetic footcare profile, longer DM duration and higher HbA1c. At the end of the follow up, 111 people died: 96 (1.6%) without and 15 (25.4%) with amputations (p < .001). CONCLUSIONS: This retrospective study provides detailed insight into the rate of amputations in Dutch people with diabetes in the region Zwolle. Compared with previous Dutch estimates, these data suggest a considerable decrease in the major amputation incidence rate.

Editor's Choice - Two Year Results of the Randomised DISCOVER Trial Comparing Covered Versus Bare Metal Stents in the Common Iliac Artery.

OBJECTIVE: It has been suggested that covered stents (CS) may lower restenosis rates compared with bare metal stents (BMS) after endovascular treatment of the common iliac artery. This trial aimed to provide additional evidence on the efficacy of CS vs. BMS in the common iliac artery. METHODS: This multicentre, randomised, single blind controlled superiority trial compared balloon expandable CS and balloon expandable BMS for advanced atherosclerotic lesions in the common iliac artery; this was defined as a stenosis > 3 cm in length or occlusion. The primary end point was freedom from binary restenosis after two years of follow up. The study was conducted according to the principles of the Declaration of Helsinki (version: October 2008) and registered with the Dutch Trial register (NTR3381). RESULTS: One hundred and seventy-four limbs were included between 2012 and 2019 with 87 limbs in each group. Six patients crossed over from the BMS group to the CS group but were analysed according to an intention to treat principle. Freedom from binary restenosis after two years of follow up was 84.7% (95% CI 76.7 - 92.7%) in the BMS group and 89.1% (95% CI 82.4 - 95.8%) in the CS group (p = .40). Freedom from occlusion was 95.0% (95% CI 90.3 - 95.7%) in the BMS group and 96.4% (95% CI 92.5 - 100%) in the CS group (p = .66). Freedom from target lesion revascularisation was 91.1% (95% CI 84.8 - 97.3%) and 95.2% (95% CI 90.7 -99.7%), respectively (p = .31). Technical success, complications, haemodynamic success, and clinical success were also comparable between both groups. Per-protocol analysis did not affect the outcomes of the study. CONCLUSION: No difference was found between balloon expandable CS and BMS for treating advanced atherosclerotic lesions of the common iliac artery.

Long-Term Outcome for Covered Endovascular Reconstruction of Aortic Bifurcation for Aortoiliac Disease: A Single-Center Experience.

PURPOSE: The gold standard for the treatment of complex (TASC II C and D) atherosclerotic aortoiliac lesions is still open surgical repair. Endovascular techniques have a lower mortality and morbidity rate but this comes at the cost of worse patency rates when compared with open repair. Improved short- and mid-term results have been reported using the covered endovascular reconstruction of aortic bifurcation (CERAB) technique. The aim of this study was to report our initial experience with the CERAB technique and report long-term patency rates. MATERIALS AND METHODS: All patients treated with the CERAB technique between 2012 and 2018 were prospectively registered in an institutional database and included in this study. Patient demographics, characteristics, symptoms, procedural, and follow-up details were collected and analyzed retrospectively. Perioperative complications and reinterventions were also identified. The Kaplan-Meier survival method was used to assess cumulative rates of patency. RESULTS: A total of 44 patients were treated with the CERAB technique and included in this study. The majority of the treated aortoiliac occlusions were classified as complex: TASC II C (n=7; 15.9%) or TASC II D (n=25; 56.8%). Primary patency rate at 60 months was 83.3%, assisted primary patency was 90.9% and secondary patency 95%. No significant differences were found in patency rates comparing noncomplex (TASC II A and B) and complex (TASC II C and D) aortoiliac lesions. Seven patients (15.9%) required at least one additional procedure to maintain either assisted primary patency or secondary patency during follow-up. The 30-day complication rate in this series was 20.5% (n=9), of which 55.6% (n=5) were minor complications. All major 30-day complications (n=4) occurred during or directly after the CERAB procedure. Thirty-day mortality was 0%. No limb occlusions occurred within 30 days of the procedure. CONCLUSION: Good long-term patency rates can be achieved with the CERAB technique to treat aortoiliac stenosis or occlusions while maintaining advantages associated with endovascular interventions. This remains true even when a CERAB is used to treat complex aortoiliac lesions. An endo-first approach to treat complex aortoiliac lesions seems viable.

Randomized multicenter trial on percutaneous versus open access in endovascular aneurysm repair (PiERO).

BACKGROUND: In endovascular valve and aortic repair, vascular access through a percutaneous approach has become the competing technique to an open surgical approach. The effect on postoperative complications and surgical site infections (SSIs) has been investigated, but randomized evidence is lacking. The objective was to investigate whether percutaneous access of the common femoral artery (CFA) with a percutaneous closure device would decrease the number of SSIs compared with open surgical access of the CFA in endovascular aneurysm repair (EVAR). METHODS: Patients with an abdominal aortic aneurysm suitable for EVAR were randomized to open or percutaneous access of the main device (MD) through the CFA. Through the contralateral side, access was obtained with the other technique than the one for which the MD was randomized. The primary outcome was number of SSIs. Secondary outcomes were wound complications, visual analog scale for pain scores, and standardized wound assessment scores during follow-up. Preoperative screening culture and groin biopsy specimens were obtained from all patients. RESULTS: Both groups contained 137 groins. SSI rate was 1.5% in the open group vs 0% in the percutaneous group. For MDs only, SSI rate was 3.1% (odds ratio, 3.3; 95% confidence interval, 0.31-347; P = .34). Wound complications were comparable in both groups. Neither nasal nor groin Staphylococcus aureus carriage had a significant effect on SSIs, Southampton Wound Assessment score, or visual analog scale score. Adjusted pain score was 0.69 lower, in favor of percutaneous access. Wound assessment was better after 2 weeks (odds ratio, 3.57; 95% confidence interval, 1.02-12.44; P = .046), also in favor of percutaneous access. CONCLUSIONS: Percutaneous access of the CFA does not reduce the number of SSIs. It does, however, reduce pain and improve wound healing with less inflammation 1 day and 2 weeks after EVAR, respectively.

A comparison of Percutaneous femoral access in Endovascular Repair versus Open femoral access (PiERO): study protocol for a randomized controlled trial.

BACKGROUND: Access for endovascular repair of abdominal aortic aneurysms (EVAR) is obtained through surgical cutdown or percutaneously. The only devices suitable for percutaneous closure of the 20 French arteriotomies of the common femoral artery (CFA) are the Prostar(™) and Proglide(™) devices (Abbott Vascular). Positive effects of these devices seem to consist of a lower infection rate, and shorter operation time and hospital stay. This conclusion was published in previous reports comparing techniques in patients in two different groups (cohort or randomized). Access techniques were never compared in one and the same patient; this research simplifies comparison because patient characteristics will be similar in both groups. METHODS/DESIGN: Percutaneous access of the CFA is compared to surgical cutdown in a single patient; in EVAR surgery, access is necessary in both groins in each patient. Randomization is performed on the introduction site of the larger main device of the endoprosthesis. The contralateral device of the endoprosthesis is smaller. When we use this type of randomization, both groups will contain a similar number of main and contralateral devices. Preoperative nose cultures and perineal cultures are obtained, to compare colonization with postoperative wound cultures (in case of a surgical site infection). Furthermore, patient comfort will be considered, using VAS-scores (Visual analog scale). Punch biopsies of the groin will be harvested to retrospectively compare skin of patients who suffered a surgical site infection (SSI) to patients who did not have an SSI. DISCUSSION: The PiERO trial is a multicenter randomized controlled clinical trial designed to show the consequences of using percutaneous access in EVAR surgery and focuses on the occurrence of surgical site infections. TRIAL REGISTRATION: NTR4257 10 November 2013, NL44578.042.13.

Endovascular abdominal aortic aneurysm repair complicated by spondylodiscitis and iliaco-enteral fistula.

Infections of abdominal aortic endografts are rare. There are no reports on the association with spondylodiscitis. We report a case of a 74-year-old man who underwent endovascular aneurysm repair (EVAR) and subsequently femorofemoral bypass placement due to occlusion of the right limb of the endograft. Six months later, he presented with rectal bleeding, weight loss, back pain, and low abdominal pain. Computed tomography revealed extensive abscess formation with air in and around the endograft and psoas muscles, in continuity with destructive spondylodiscitis L3-4. There was a small bowel loop in close proximity to the occluded right leg of the endograft, which was filled with air bubbles. An axillofemoral bypass was created followed by a laparotomy. Intra-operatively, an iliaco-enteral fistula was found. The small bowel defect was sutured, the endograft completely removed, and the infrarenal aorta and both common iliac arteries were closed. Necrotic fragments of the former L3-4 disk were removed. The postoperative course was uneventful. Seven months postoperatively, the patient had recovered well. Iliaco-enteric fistula and spondylodiscitis are rare complications of aortic aneurysm repair. This is the first report of spondylodiscitis after EVAR.