Initial Clinical Experience With AneuFix Injectable Biocompatible Elastomer for Translumbar Embolization of Type 2 Endoleaks.

PURPOSE: The aim of this study was to assess the initial experience, technical success, and clinical benefit of AneuFix (TripleMed, Geleen, the Netherlands), a novel biocompatible and non-inflammatory elastomer that is directly injected into the aneurysm sac by a translumbar puncture in patients with a type II endoleak and a growing aneurysm. MATERIALS AND METHODS: A multicenter, prospective, pivotal study was conducted (ClinicalTrials.gov:NCT02487290). Patients with a type II endoleak and aneurysm growth (>5 mm) were included. Patients with a patent inferior mesenteric artery connected to the endoleak were excluded for initial safety reasons. The endoleak cavity was translumbar punctured with cone-beam computed tomography (CT) and software guidance. Angiography of the endoleak was performed, all lumbar arteries connected to the endoleak were visualized, and AneuFix elastomer was injected into the endoleak cavity and short segment of the lumbar arteries. The primary endpoint was technical success, defined as successful filling of the endoleak cavity with computed tomography angiography (CTA) assessment within 24 hours. Secondary endpoints were clinical success defined as the absence of abdominal aortic aneurysm (AAA) growth at 6 months on CTA, serious adverse events, re-interventions, and neurological abnormalities. Computed tomography angiography follow-up was performed at 1 day and at 3, 6, and 12 months. This analysis reports the initial experience of the first 10 patients treated with AneuFix. RESULTS: Seven men and 3 women with a median age of 78 years (interquartile range (IQR), 74-84) were treated. Median aneurysm growth after endovascular aneurysm repair (EVAR) was 19 mm (IQR, 8-23 mm). Technical success was 100%; it was possible to puncture the endoleak cavity of all treated patients and to inject AneuFix. Clinical success at 6 months was 90%. One patient showed 5 mm growth with persisting endoleak, probably due to insufficient endoleak filling. No serious adverse events related to the procedure or AneuFix material were reported. No neurological disorders were reported. CONCLUSION: The first results of type II endoleak treatment with AneuFix injectable elastomer in a small number of patients with a growing aneurysm show that it is technically feasible, safe, and clinically effective at 6 months. CLINICAL IMPACT: Effective and durable embolization of type II endoleaks causing abdominal aortic aneurysms (AAA) growth after EVAR is challenging. A novel injectable elastic polymer (elastomer) was developed, specifically designed to treat type II endoleaks (AneuFix, TripleMed, Geleen, the Netherlands). Embolization of the type II endoleak was performed by translumbar puncture. The viscosity changes from paste-like during injection, into an elastic implant after curing. The initial experience of this multicentre prospective pivotal trial demonstrated that the procedure is feasible and safe with a technical success of 100%. Absence of AAA growth was observed in 9 out of 10 treated patients at 6 months.

Improved outcomes in patients with diabetic foot ulcers despite of differences in baseline characteristics.

The incidence of diabetes is increasing worldwide with concomitant raising number of patients with diabetic foot disease. Diabetic foot disease treatment has received more attention in the past decades, culminating in the creation of multidisciplinary outpatient clinics, but at the same time, complexity of patients seems to have increased. The aim of this article is to study differences in patient characteristics and outcomes (ulcer healing and ulcer-free survival days) in patients with a diabetic foot ulcer in two prospective cohorts with 15 years in between. Prospective cohort study of all patients in one diabetic foot centre of expertise in 2003-2004 and 2014-2018. Clinical outcomes were determined after a follow-up period of 12 months. Outcomes were differences in baseline characteristics and comorbidities, and differences in ulcer-related outcomes between both cohorts. We included all consecutive diabetic foot ulcer patients from our centre for the period 2003-2004 (n = 79) and 2014-2018 (n = 271). Age (67.0 ± 14.3 vs. 71.6 ± 11.5, p = 0.003) and prevalence of end-stage renal disease (1.3% vs. 7.7%, p = 0.036) were significantly higher in the more recent population. The more recent population had higher healing rate (53.2% vs. 76.4%, p < 0.001), higher median ulcer-free survival days once an ulcer had healed [173 days (IQR 85.3-295.5) vs. 257.0 (IQR 157.0-318.0), p = 0.026], and fewer minor amputations (20.3% vs. 8.1%, p = 0.002). People with diabetic foot ulcers treated in 2014-2018 were older and more frequently diagnosed with ESRD, compared to this population in 2003-2004, while other characteristics were similar; ulcer-related outcomes were better.

Infrared thermography for monitoring severity and treatment of diabetic foot infections.

Monitoring of diabetic foot infections is largely based on clinical assessment, which is limited by moderate reliability. We conducted a prospective study to explore monitoring of thermal asymmetry (difference between mean plantar temperature of the affected and unaffected foot) for the assessment of severity of diabetic foot infections. In patients with moderate or severe diabetic foot infections (International Working Group on the Diabetic Foot infection-grades 3 or 4) we measured thermal asymmetry with an advanced infrared thermography setup during the first 4-5 days of in-hospital treatment, in addition to clinical assessments and tests of serum inflammatory markers (white blood cell counts and C-reactive protein levels). We assessed the change in thermal asymmetry from baseline to final assessment, and investigated its association with infection-grades and serum inflammatory markers. In seven included patients, thermal asymmetry decreased from median 1.8°C (range: -0.6 to 8.4) at baseline to 1.5°C (range: -0.1 to 5.1) at final assessment (P = 0.515). In three patients who improved to infection-grade 2, thermal asymmetry at baseline (median 1.6°C (range: -0.6 to 1.6)) and final assessment (1.5°C (range: 0.4 to 5.1)) remained similar (P = 0.302). In four patients who did not improve to infection-grade 2, thermal asymmetry decreased from median 4.3°C (range: 1.8 to 8.4) to 1.9°C (range: -0.1 to 4.4; P = 0.221). No correlations were found between thermal asymmetry and infection-grades (r = -0.347; P = 0.445), CRP-levels (r = 0.321; P = 0.482) or WBC (r = -0.250; P = 0.589) during the first 4-5 days of hospitalization. Based on these explorative findings we suggest that infrared thermography is of no value for monitoring diabetic foot infections during in-hospital treatment.

Collateral artery pathways of the femoral and popliteal artery.

BACKGROUND: The role of collateral artery circulation in the lower limb is under debate but clinically relevant, particularly when using covered stents for occlusive disease. Covered stents seem to outperform nitinol stents in extensive disease, but collaterals could be essential in case of acute thrombosis. In the present study, we describe the collateral pathways of the deep and superficial femoral artery (DFA, SFA) and the popliteal artery (PA), observed in human cadavers. METHODS: Ten fresh frozen cadaver legs were selected. The SFA and DFA were separately cannulated and injected with a different colored latex mixture simultaneously. After curing of the latex, the circulation was dissected thus visualizing the main arteries and their collateral vessels. The process was photographed and recorded, and collateral pathways were analyzed using a standardized vessel segmentation. The upper leg was divided in three regions, that is, the femoral triangle (F), the adductor canal (H), and the popliteal fossa (P) that, in turn, were split in three segments (1, 2, and 3, from proximal to distal). RESULTS: Overall, 113 collateral vessels were found; 69 originated from the DFA, 34 from the SFA, and 10 from the PA. The majority of collaterals originating from the DFA terminated in the SFA (57%). Fifty-six of 113 collaterals (50%) ended in either the distal adductor channel (H3) or the proximal PA (P1). Another 28 collateral arteries (25%) had their origin in this segment (H3, P1) and mostly connected to the P2 and P3 segments. Forty-three collaterals of the DFA and H3 segment had a direct or indirect connection to below the knee muscles. CONCLUSIONS: The majority of collaterals originate from the DFA, and the greater part of all collaterals has a connection with the H3-P1 segment. This observation may have clinical implications in the planning of endovascular procedures.

Morbidity of femoropopliteal bypass surgery.

A systemic review of published reports on the incidence of early (<30 days) adverse events occurring after above- or below-knee femoropopliteal bypass surgery was conducted to provide contemporary outcomes data for comparative reporting. A total of 38 articles were included describing 6,374 femoropopliteal bypasses in 6,007 patients. Fifty-two percent were male and the mean age was 64.6 years (range, 40 to 93 years). The various studied types of complications were reported in 10 to 34 of 38 articles and definitions were often missing. The overall 30-day morbidity rate was 36.8%. The wound infection rate was 7.8% (range, 0.0 to 17.4%) accompanied with dermal necrosis in 0.4%. Graft infection was described in 2.4% (range, 0.0 to 5.3%) of cases. Postoperative bleeding was seen in 7.4% (range, 0.0 to 26%), of which 2.5% required return to surgery. Occlusions were reported in 12.0% (range, 0.0 to 59%). Lymphedema occurred in 2.9% (range, 0.0 to 9.6%) of cases and surgical site seroma formation occurred in 2.0% (range, 1.0% to 3.0%). Overall 30-day mortality rate was 2.3% (range 0.0 to 4.3%). Pooled data comparing vein grafts and prosthetic grafts revealed no significant difference (P = .10; risk ratio = 0.82; 95% confidence interval, 0.66-1.03; I(2) = 0%) in the incidence of complications. This review confirmed the morbidity of femoropopliteal bypass surgery is inconsistently reported and definitions are lacking. Because one-third of patients can be expected to experience an adverse event after femoropopliteal bypass grafting, standards on defining and reporting complications are necessary if comparative outcome standards are developed.

[Sinus pericranii; a congenital swelling on the scalp]. / Sinus pericranii; een congenitale zwelling op het behaarde hoofd.

BACKGROUND: Sinus pericranii is a rare congenital disorder of the skull. It involves a venous connection between the intracranial and extracranial venous systems caused by a defect at the level of a cranial sinus. CASE DESCRIPTION: We present the case of a 20-year-old woman with a soft compressible swelling on the back of her head from birth. MRI examination revealed sinus pericranii. The treatment consisted of coagulating the venous connection and closing the cranial malformation. CONCLUSION: In a patient with soft-tissue swelling on the back of the head that has been present since birth, differential diagnostics should extend beyond epidermoid cysts alone and also include consideration of sinus pericranii. This is particularly important if the swelling is in the midline.

Five-Year Outcome of Self-Expanding Covered Stents for Superficial Femoral Artery Occlusive Disease and an Analysis of Factors Predicting Failure.

PURPOSE: To investigate the 5-year outcome of patients treated with self-expanding covered stents for superficial femoral artery (SFA) occlusive disease and identify parameters that could predict loss of primary patency. METHODS: In a dual-center study, 315 consecutive patients (mean age 69.0±10.1 years; 232 men) treated for SFA occlusive disease in 334 limbs with Viabahn self-expanding covered stents between 2001 and 2014 were retrospectively analyzed. Mean lesion length was 11.7±8.8 cm, and half of the lesions were classified as TASC II C/D. Five-year patency rates were calculated, and Cox regression analyses were performed to assess potential factors affecting patency. RESULTS: All-cause mortality at 5 years was 14.1%. Primary patency rates at 1, 3, and 5 years were 72.2%, 51.8%, and 47.6%, respectively, with secondary patency rates of 86.2%, 78.7%, and 77.5%. Parameters predicting loss of primary patency in a univariate analysis were covered stent diameter (p=0.001), the number of covered stents per lesion (p=0.015), and TASC II D classification (p=0.007). Covered stent diameter was the only parameter predicting loss of primary patency in the multivariate regression analysis (p=0.001), with 7-mm covered stents having superior performance. CONCLUSION: Five-year patency rates of self-expanding covered stents inserted for SFA occlusive disease are within an acceptable range. Covered stent diameter is the most relevant factor in predicting loss of primary patency, and thus, an adequate diameter of the distal landing site seems to be among the most important factors in the decision-making process. In smaller vessels, one should not use covered stents but venous conduits, as oversizing may be detrimental.

Efficacy of treatment of edge stenosis of endografts inserted for superficial femoral artery stenotic disease.

OBJECTIVE: The role of endografts in the treatment of extensive superficial femoral artery (SFA) occlusive disease is enlarging. Results are limited by the occurrence of edge stenosis. The aim of the study was to retrospectively evaluate the efficacy of treatment of edge stenosis of endografts inserted for SFA occlusive disease. METHODS: All patients, treated between November 2001 and December 2011, with a self-expandable polytetrafluoroethylene-endograft were gathered in a prospective database in three hospitals. The incidence of primary edge stenosis and the incidence of re-edge stenosis after treatment were retrospectively noted and a comparison was made between the results of percutaneous transluminal angioplasty (PTA) and extension of the endograft. RESULTS: A total of 88 patients presented with 115 edge stenoses, of which the majority presented within 1 year after insertion of the endograft (mean time to edge stenosis 10.7 ± 8.2 months). Seventy-three stenoses (63%) manifested at the proximal and 42 at the distal edge (37%). The 1-year incidence of restenosis and/or occlusion was 45% after PTA and 43% after endograft extension, with 1-year patency rates of 81% and 92%, respectively. The incidence of restenosis/occlusion after treatment with PTA was 12% higher at two years compared to extension of the endograft (55% vs. 43%, respectively). CONCLUSION: Edge stenosis may well be treated with either PTA or extension of the endograft. The incidence of restenosis and/or occlusion after both PTA and extension is high, but patency rates are acceptable. Aggressive surveillance is needed during the first year after insertion.

The outcome of failed endografts inserted for superficial femoral artery occlusive disease.

OBJECTIVE: Endografts represent a relatively new treatment modality for occlusive disease of the superficial femoral artery, with promising results. However, endografts may occlude collateral arteries, which may affect outcome in case of failure. The purpose of this study was to analyze the clinical outcome of failed endografts in patients with superficial femoral artery occlusive disease. METHODS: All patients treated with one or more polytetrafluorethylene-covered stents between November 2001 and December 2011 were prospectively included in a database. Patients with a failure of the endograft were retrospectively analyzed. Clinical and hemodynamic parameters were assessed before the initial procedure and at the time of failure. Outcome of secondary procedures was analyzed. RESULTS: Among the 341 patients who were treated during the study period, 49 (14.4%) failed during follow-up. Mean (standard deviation) Rutherford category at failure did not differ from the category as scored before the initial procedure (3.1 [1.3] vs 3.3 [0.6]; P = .33). Forty-three percent of patients (n = 21) presented with the same Rutherford category as before the initial procedure, 37% (n = 18) with an improved category, and 20% (n = 10) with a deteriorated category. The ankle-brachial index was significantly lower at the time of failure (0.66 [0.19] vs 0.45 [0.19[; P <.002). Seventy-six percent of patients with a failure needed secondary surgery, of which 25% were below knee. The 1-year primary, primary-assisted, and secondary patency rates of secondary bypasses were 55.1%, 62.3%, and 77.7%, respectively. The amputation rate was 4.1% (n = 2). CONCLUSIONS: Failure of endografts is not associated with a deterioration in clinical state and is related to a low amputation rate. The hypothesis that covered stents do not affect options for secondary reconstructions could not be confirmed, as 25% of patients with a failure underwent a below-knee bypass. Secondary surgical bypasses are correlated with poor patency. The amputation rate after failure is low.

(Semi-)closed endarterectomy in occlusive aortoiliac disease.

BACKGROUND: Evaluation of the long-term results of a (semi-) closed endarterectomy of the aortoiliac segment with the use of the arterial disobliteration device. METHODS: From 1984 until 2005, a total of 157 patients (mean age, 53 years) with aortoiliac occlusive disease underwent a (semi-)closed endarterectomy of the aortoiliac segment. The primary operation indication was disabling claudication in 60.5% and advanced symptoms of ischemia or gangrene in 39.5%. The (semi-) closed endarterectomy was performed in 75% through a standard left retroperitoneal approach. RESULTS: Mean follow-up time was 18.2 years. Primary patency was 96% after 5 and 92% after 10 years. Fourteen patients underwent a reintervention within 30 days. The operative 30-day mortality rate was 1.5%. A reintervention for recurrence of occlusive disease during follow-up was necessary in 22 patients. At follow-up after an average of 18.2 years, 105 patients were alive, with 52 not related deaths. CONCLUSION: Retroperitoneal (semi-) closed disobliteration, with the use of the arterial disobliteration device, of the aortoiliac segment for stenotic and occlusive vascular disease is a safe and successful procedure the results of which are comparable with the implantation of a vascular aortic prosthesis. We consider this technique a valuable tool in vascular surgery.