Long-term follow-up of the Derivo® Embolization Device (DED®) for intracranial aneurysms: the Italian Multicentric Registry.

BACKGROUND: The flow-diverter devices (FDDs) safety and effectiveness have been demonstrated by large series and meta-analyses. Due to the high occlusion rates and the acceptable morbidity rates of FDDs, the indications for their use are continuously expanding. We presented our Italian multicentric experience using the second generation of DERIVO® Embolization Device (DED®; Acandis, Pforzheim, Germany) to cure cerebral aneurysms, evaluating both middle and long-term safety and efficacy of this device. METHODS: Between July 2016 and September 2017 we collected 109 consecutive aneurysms in 108 patients treated using DED® during 109 endovascular procedures in 34 Italian centers (100/109 aneurysms were unruptured, 9/109 were ruptured). The collected data included patient demographics, aneurysm location and characteristics, baseline angiography, adverse event and serious adverse event information, morbidity and mortality rates, and pre- and post-treatment modified Rankin Scale scores. Midterm and long-term clinical, angiographic and cross-sectional CT/MR follow-up were recorded and collected until December 2018. RESULTS: In 2/109 cases, DED® placement was classified as technical failures. The overall mortality and morbidity rates were respectively 6.5% and 5.5%. Overall DERIVO® related mortality and morbidity rates were respectively 0% and 4.6% (5 out of 108 patients). Midterm neuroimaging follow-up showed the complete or nearly complete occlusion of the aneurysm in 90% cases, which became 93% at long-term follow-up. Aneurysmal sac shrinking was observed in 65% of assessable aneurysms. CONCLUSIONS: Our multicentric experience using DED® for endovascular treatment of unruptured and ruptured aneurysms showed a high safety and efficacy profile, substantially equivalent or better compared to the other FDDs.

Overcoming metallic artefacts from orthopaedic wrist volar plating on a low-field MRI scanner.

PURPOSE: To quantitatively compare the artefact reduction between standard and metallic artefact reduction (MAR) fast spin echo (FSE) T2 sequences in a low-field magnetic resonance imaging (MRI) scanner (0.3 T) in patients with titanium volar wrist plating. MATERIALS AND METHODS: Sixteen patients with fractures of the distal radius, treated with titanium volar wrist plating and screws, were examined using a dedicated 0.3 T MRI scanner. Coronal standard FSE T2, FSE T2 high bandwidth (HiBW) and FSE T2 view angle tilting (VAT) sequences were performed. Metallic artefact volume, consisting of both "black" and "bright" artefacts, was calculated for each sequence. Quantitative differences were compared using repeated measures ANOVA test (P < 0.05). RESULTS: FSE T2 HiBW and FSE T2 VAT showed a significant reduction in artefact volume compared to the standard sequence. Differences between the artefact volume of the standard FSE T2, HiBW and VAT sequences were statistically significant for both the "black" and "bright" artefacts (P < 0.0001). Differences between the 1.5 HiBW and VAT sequences were statistically significant (black P < 0.0001, bright P < 0.0302). CONCLUSIONS: MAR sequences significantly reduced metallic artefacts in vivo using a 0.3 T MRI scanner.

Long-term follow-up in the endovascular treatment of intracranial aneurysms with flow-diverter stents: update of a single-centre experience.

INTRODUCTION: Flow-diverter stents are becoming a useful tool in treating patients with intracranial aneurysms with suitable anatomical feature. Purpose of this study was to evaluate effectiveness and safety of endovascular treatment with flow-diverting stents (FD) in unruptured intracranial aneurysms. METHODS: From May 2009 and May 2014, we treated 49 patients with a total of 58 aneurysms, with FD technique. All patients were treated electively, under general anesthesia and were administered single antiplatelet drug 5 days before the procedure and double antiplatelet therapy for 3 months afterwards. Fifteen of the patients were asymptomatic, eight had headache, thirteen patients presented symptoms due to mass effect of the aneurysm on CNS structures, twelve were treated due to a post-surgical relapse and one patient presented relapsing TIAs due to distal embolization from the aneurysm dome. Choice of FD treatment was done according to aneurysm anatomy (fusiform over saccular, dome/neck ratio < 2) and whenever conventional treatment (coil embolization) appeared difficult (eg. Large aneurysm neck, fusiform aneurysms or difficult sac catheterization). We considered a dome/neck ratio > 2 as the only exclusion criteria. RESULTS: Successful stent deployment was achieved in 50 procedures out of 52 (94.34%) while overall mortality was 2% (1/49). Forty-eight patients were evaluated at long-term follow-up for a total of 56 treated aneurysms. At 3 months, follow-up 75% (42/56) of the aneurysms were excluded from intracranial circulation, at 6 months 80.35% (45/56) and at 12 months 84% (47/56). Stent patency was observed in 100% of patients at short and long-term follow-up, with only two cases of intimal hyperplasia at 3 months, without any further complications. CONCLUSIONS: According to our study FD repair of unruptured intracranial aneurysms appeared to be a safe and effective technique, especially in selected patients with hostile anatomy for traditional embolization.

Endoluminal Dilation Technique to Remove Stuck Port-A-Cath: A Case Report.

Port-a-cath is a type of central venous catheter (CVC) designed to allow repeated access to the venous system for parenteral delivery of medications, fluids, and nutritional solutions and for sampling venous blood. After years of use or in case of damage, CVC must be removed and eventually replaced: the recovery of the device should normally be easy, with a small surgical incision of the skin and tissues surrounding the device and pulling the catheter. Sometimes, scar tissue can develop around the device, making it resistant to removal even after application of forceful traction. We report a case of stuck port-a-cath that was extracted by using endoluminal dilatation technique.

Are abdominal aortic aneurysms with hostile neck really unsuitable for EVAR? Our experience.

OBJECTIVE: To evaluate the effectiveness of endovascular treatment of abdominal aortic aneurysms with hostile neck, comparing the results with those of patients with ideal anatomical conditions. MATERIALS AND METHODS: From January 2005 to December 2013, 300 patients were treated with EVAR at our institution. Patients with a prior Angio-CT scan were included in the study and they were then retrospectively divided into two groups: patients with suitable anatomy that were treated within guidelines of the manufacturers (wIFU: 94 patients, four treated in emergency) and those with unsuitable anatomy that were treated outside of said guidelines (oIFU: 70 patients, 16 treated in emergency). Patients without prior CT study and without follow-up were excluded from the study. RESULTS: Postoperative mortality was 6.3 % in the wIFU group while it was 7.8 % in the oIFU group. There was not a statistically significant difference in the rate of postoperative mortality (p = 0.653). Technical success was 98.6 % in the wIFU group while it was 94.5 % in the oIFU group. All the patients of the wIFU group were treated with a stent-graft with under-renal sealing while in the oIFU group always an over-renal stent-graft was used. No deaths related to the aneurysm were highlighted at follow-up in both groups. There was a statistically significative difference between the two groups regarding intraoperative occlusion of renal arteries (wIFU = 1.1 %; oIFU = 4.7 %; p < 0.05) and in the development of type I endoleak (wIFU = 2.8 %; oIFU = 8.8 %; p < 0.05) CONCLUSION: EVAR in patients with hostile neck is feasible and effective with an acceptable rate of complications.

Quantitative assessment of atrial conduit function: a new index of diastolic dysfunction.

BACKGROUND: Heart failure (HF) epidemic has increased need for accurate diastolic dysfunction (DD) quantitation. Cardiac MRI can elucidate left atrial (LA) phasic function, and accurately quantify its conduit contribution to left ventricular (LV) filling, but has limited availability. We hypothesized that the percentage of LV stroke volume due to atrial conduit volume (LACV), as assessed using 3D-echocardiography, can differentiate among progressive degrees of DD in HF patients. METHODS AND RESULTS: Sixty-three subjects (66 ± 12 years) with DD and ejection fraction (EF) ranging 14-62% underwent full-volume 3D-echocardiography. Simultaneous LA and LV volume curves as function of time (t) were calculated, with LACV as LACV(t) = [LV(t) - LV minimum] - [LA maximum LA(t)], expressed as % of stroke volume. Patients were assigned to four (0-3, from none to severe) DD grades, according to classical Doppler parameters. In this population DD is linked to LACV, with progressively higher percentages of conduit contribution to stroke volume associated with higher degrees of DD (p = 0.0007). Patients were then dichotomized into no-mild (n = 26) or severe (n = 37) DD groups. Apart from atrial volume, larger (p < 0.02) in severe DD group, no differences between groups were found for LV diastolic and stroke volume, EF, mass and flow propagation velocity. However, a significant difference was found for LACV expressed as % of LV stroke volume (29 ± 15 vs. 43 ± 23%, p = 0.016). CONCLUSIONS: Our study confirms that LACV contribution to stroke volume increases along with worsening DD, as assessed in the context of (near) constant-volume four-chamber heart physiology. Thus, LACV can serve as new parameter for DD grading severity in HF patients.

Cumulative radiation dose and radiation risk from medical imaging in patients subjected to endovascular aortic aneurysm repair.

PURPOSE: This study was undertaken to quantify the cumulative effective dose (CED) of radiation and the dose to relevant organs in endovascular aortic repair (EVAR) patients, to assess radiation risks and to evaluate the clinical usefulness of multi-detector computed tomography (MDCT) follow-up. MATERIALS AND METHODS: The radiation exposures were obtained from 71 consecutive EVAR patients with a follow-up duration ≥1 year. Dose calculations were performed on an individual basis and expressed as effective doses and organ doses. Radiation risk was expressed as risk of exposure-induced death (%), using the biological effects of ionising radiation model. Two radiologists independently assessed the images for abdominal aortic aneurysm expansion without endoleaks, thrombotic occlusion, endoleaks and device migration. They first reviewed arterial imaging alone and subsequently added non-contrast and delayed phases to determine the overall performance. RESULTS: The median total CED and annual CED were 224 and 104 mSv per patient-year. The median cumulative organ doses were 191, 205, 230, 269 and 271 mSv for lung, bone marrow, liver, colon and stomach, respectively. The average risk of exposure-induced death was 0.8 % (i.e., odds 1 in 130). All the findings related to EVAR outcome and leading to a change in patient management were visible during the arterial phase of the MDCT angiography. Omission of the unenhanced scan and the venous phase of the MDCT angiography would have led to a significant reduction of about 60 % of the associated MDCT radiation exposure in a single patient. CONCLUSIONS: EVAR patients received high radiation doses and the excess cancer risk attributable to radiation exposure is not negligible. The unenhanced scan and the venous phase of the MDCT angiography could have been omitted without compromising the utility of the examination and with a significant reduction of doses and associated risks.

Isolated iliac artery aneurysms: a single-centre experience.

PURPOSE: This paper reviews our experience in endovascular treatment of isolated iliac artery aneurysms (IIAAs) with a large number of patients. MATERIALS AND METHODS: From May 2005 to September 2013, 45 patients (43 men and two women; mean age, 74 ± 10 years) with a total of 59 IIAAs underwent endovascular treatment at our institute. We evaluated technical success, long-term patency, early and late complications and overall mortality. Patients were divided into two groups: emergency-treatment group and elective-treatment group. RESULTS: At a median follow-up of 34.3 months, we achieved a technical success of 97.8 %, a primary patency of 95.5 % and a secondary patency of 100 %, with complete exclusion of the aneurysm in 84.5 % of cases. The incidence of endoleaks was of 15.5 %: eight were type II and one was type III; perioperative mortality was 4.7 %. CONCLUSIONS: Our study documents the effectiveness, in both emergency and elective settings, of the endovascular treatment of iliac aneurysms (EVIAR), which has become the first-choice treatment at our institute. In particular cases, it is also possible to avoid embolisation of the internal iliac artery.

Management of postbiopsy arteriovenous fistulas in transplanted kidneys and effectiveness of endovascular treatment: a single-center experience.

BACKGROUND: We sought to evaluate the best therapeutic management of postbiopsy arteriovenous fistulas (AVFs) in transplanted kidneys. METHODS: Between January 2005 and December 2011, we observed 17 cases of postbiopsy AVF in transplanted kidneys (9 asymptomatic; 8 symptomatic). Asymptomatic cases were managed conservatively, while patients with symptomatic AVF underwent endovascular treatment. We used a technique that consisted in a superselective transcatheter embolization of the afferent branch. We evaluated the technical success (postoperative closure of AVF), the immediate clinical efficacy (cessation of symptoms), and clinical efficacy at follow-up (measurement of serum creatinine at 7 days and 6 and 12 months compared with preoperative levels using t-tests). RESULTS: Asymptomatic AVFs resolved spontaneously, while the endovascular treatment in symptomatic AVFs showed a complete technical and clinical success with prompt remission of the presented symptoms. We observed a statistically significant reduction in serum creatinine at 7 days and 6 and 12 months postoperatively (mean creatinine--preoperative: 3.23 ± 1.4 mg/dL; 7 days: 2.25 ± 0.8 mg/dL; 6 months: 1.65 ± 0.28 mg/dL; 12 months: 1.4 ± 0.26 mg/dL; in all cases P < 0.05). CONCLUSIONS: In our experience, asymptomatic AVFs could be managed conservatively with close follow-up while the endovascular treatment for symptomatic AVFs is both safe and effective in the short- and long-term.

Endovascular treatment of ruptured abdominal aortic aneurysms: is now EVAR the first choice of treatment?

OBJECTIVE: This study was designed to evaluate the effectiveness of endovascular treatment (EVAR) for ruptured abdominal aortic aneurysms (rAAAs). METHODS: Between September 2005 and December 2012, 44 patients with rAAA suitable for endovascular repair underwent emergency EVAR. We did not consider hemodynamic instability to be a contraindication for EVAR. RESULTS: Successful stent-graft deployment was achieved in 42 patients, whereas 2 required open surgical conversion. The overall 30-day mortality was 10 of 44 patients (5/34 in stable patients, 5/10 in unstable patients). Postoperative complications were observed in 7 of 44 patients (16 %): 5 patients developed abdominal compartment syndrome requiring decompressive laparotomy; 1 patient developed bowel ischemia; 1 patient had limb ischemia, and 1 had hemodynamic shock. Mean length of intensive care unit stay was 2.9 (range 2­8) days, and mean length of hospital stay was 8.6 (range 0­18) days. At a mean follow-up of 22.2 (range 1­84) months, the overall incidence of endoleak was 23.5 %: 1 type I and 7 type II endoleaks. CONCLUSIONS: Our study demonstrates that EVAR of rAAA is associated with acceptable mortality and morbidity rates in dedicated centers.

Endovascular treatment of spontaneous extraperitoneal haemorrhage: immediate and long-term clinical efficiency.

PURPOSE: This study aimed to evaluate the effectiveness of transcatheter embolisation in the treatment of spontaneous extraperitoneal haemorrhage (SEH). MATERIALS AND METHODS: We retrospectively evaluated the technical and clinical success in terms of immediate and long-term mortality in a series of patients who underwent endovascular treatment of SEH from January 2005 to December 2010. A statistical comparison of pre- and postoperative transfusion requirements was performed by using the Student's t test, with statistical significance set at p < 0.005. RESULTS: In the period considered, 30 patients (16 women and 14 men; mean age, 73.3 years ±15.6) with SEH underwent endovascular treatment. Technical success was obtained in all cases (100 %), and a statistically significant reduction in blood transfusion requirements was observed (mean preoperative requirement: 7.5 U/day ±3; mean postoperative requirement 2.8 U/day) (p < 0.005). We observed a postoperative mortality of 10 % (3/30 patients) and mortality at 6 and 12 months was 14.8 % (4/27 patients) and 26 % (6/23 patients), respectively. CONCLUSION: According to our experience and to the literature, transcatheter arterial embolisation represents the treatment of choice in patients with SEH, as it ensures complete therapeutic success.

Endovascular treatment of intracranial aneurysms with flow-diverter stents: preliminary single-centre experience.

PURPOSE: This paper reports our preliminary experience with the endovascular treatment of intracranial aneurysms using flow-diverter stents (FDs) and compares it with the literature data. MATERIALS AND METHODS: From May 2009 to April 2012, 28 patients (6 men and 22 women; mean age, 54 years) with a total of 35 aneurysms were treated with FDs. We evaluated postprocedural technical success and long-term efficacy, with follow-up examinations performed at 3-7 days [computed tomography (CT)/magnetic resonance (MR) angiography] and at 3, 6 and 12 months (digital subtraction angiography, DSA). A total of 43 FDs were placed, 36 Pipeline and 7 Silk. RESULTS: A total of 30 procedures were performed (two patients were treated twice). Technical success was 96.6%, with one case of postprocedural death; the aneurysm exclusion rate at 3, 6 and 12 months was 60%, 73% and 89%, respectively. There was no case of acute stent thrombosis, and only two cases of nonsignificant stenosis. All covered side branches were patent, except one case of steno-occlusion of the ophthalmic artery. CONCLUSIONS: Our results are consistent with the literature and demonstrate the effectiveness and safety of FDs in selected cases of cerebral aneurysm (wide neck, fusiform, blister-like).

Endovascular treatment of thoracic aortic aneurysm: a single-center experience.

BACKGROUND: We assess the effectiveness of thoracic endovascular aortic repair (TEVAR) in patients with thoracic artery aneurysm with a retrospective analysis of our experience and a review of the literature. METHODS: Between January 2005 and December 2011, 53 patients with thoracic aortic aneurysm underwent TEVAR. We evaluated the technical success, periprocedural and long-term mortality and morbidity, and follow-up by enhanced computed tomographic scans at 1, 6, and 12 months and annually thereafter. RESULTS: TEVAR was performed in good general conditions in 62.3% of cases and in emergency conditions in 37.7% of cases. A total of 85 endoprostheses were correctly placed, with technical success of 100%. In 18.8% of cases, a carotid-subclavian bypass was performed; 35.8% of cases required drainage of cerebrospinal fluid. Postoperative mortality was 7.5%, and in all cases patients were treated in emergency regimen. The incidence of major postoperative complications was 9.4%, with 2 cases of paraplegia. At a mean follow-up of 25.6 months, 12 cases (22.6%) of endoleak were observed: 5 cases of type IB endoleak were treated with prosthetic extensions; 7 cases of type II endoleak were not treated. There were no thrombotic occlusions, stent migrations, or fractures. CONCLUSION: TEVAR represents an effective option in the treatment of thoracic aortic aneurysms, with good immediate and long-term results.

Endovascular treatment of diabetic foot in a selected population of patients with below-the-knee disease: is the angiosome model effective?

PURPOSE: To evaluate the efficacy of percutaneous transluminal angioplasty (PTA) in a selected population of diabetic patients with below-the-knee (BTK) disease and to analyze the reliability of the angiosome model. METHODS: We made a retrospective analysis of the results of PTA performed in 201 diabetic patients with BTK-only disease treated at our institute from January 2005 to December 2011. We evaluated the postoperative technical success, and at 1, 6, and 12 months' follow-up, we assessed the rates and values of partial and complete ulcer healing, restenosis, major and minor amputation, limb salvage, and percutaneous oximetry (TcPO2) (Student's t test). We used the angiosome model to compare different clinicolaboratory outcomes in patients treated by direct revascularization (DR) from patients treated with indirect revascularization (IR) technique by Student's t test and the χ(2) test. RESULTS: At a mean ± standard deviation follow-up of 17.5 ± 12 months, we observed a mortality rate of 3.5 %, a major amputation rate of 9.4 %, and a limb salvage rate of 87 % with a statistically significant increase of TcPO2 values at follow-up compared to baseline (p < 0.05). In 34 patients, treatment was performed with the IR technique and in 167 by DR; in both groups, there was a statistically significant increase of TcPO2 values at follow-up compared to baseline (p < 0.05), without statistically significant differences in therapeutic efficacy. CONCLUSION: PTA of the BTK-only disease is a safe and effective option. The DR technique is the first treatment option; we believe, however, that IR is similarly effective, with good results over time.

Endovascular treatment of bronchial artery aneurysm with aortic stent-graft placement and coil embolization.

Bronchial artery aneurysm (BAA) represents a rare, but dangerous, pathology because its rupture can cause a life-threatening hemorrhage; opportune treatment is mandatory when a definite diagnosis is obtained. There are several reports of endovascular treatment of BAA with transcatheter arterial embolization and only few cases treated with aortic stent-graft exclusion. We report a case of mediastinal BAA close to thoracic aorta treated with a combined approach of stent-graft occlusion of the inflow and coil embolization of the outflow arteries.

The impact of radiological equipment on patient radiation exposure during endovascular aortic aneurysm repair.

OBJECTIVES: To compare the patient radiation dose during endovascular aortic aneurysm repair (EVAR) using different types of radiological systems: a mobile fluoroscopic C-arm, mobile angiographic and fixed angiographic equipment. METHODS: Dose-area products (DAP) were obtained from a retrospective study of 147 consecutive patients, subjected to 153 EVAR procedures during a 3.5-year period. On the basis of these data, entrance surface dose (ESD) and effective dose (ED) were calculated. EVARs were performed using a fluoroscopic C-arm, mobile or fixed angiographic equipment in 79, 26 and 48 procedures, respectively. RESULTS: Fluoroscopy times were essentially equivalent for all the systems, ranging from 15 to 19 min. The clinical outcomes were not significantly different among the systems. Statistically significant differences among radiological equipment grouping were found for DAP (mobile C-arm: 32 ± 20 Gy cm(2); mobile angiography: 362 ± 164 Gy cm(2); fixed angiography: 464 ± 274 Gy cm(2); P < 10(-6)), for ESD (mobile C-arm: 0.18 ± 0.11 Gy; mobile angiography: 2.0 ± 0.8 Gy; fixed angiography: 2.5 ± 1.5 Gy; P < 10(-6)) and ED (mobile C-arm: 6.2 ± 4.5 mSv; mobile angiography: 64 ± 26 mSv; fixed angiography: 129 ± 76 mSv; P < 10(-6)). CONCLUSIONS: Radiation dose in EVAR is substantially less with a modern portable C-arm than with a fixed or mobile dedicated angiographic system. KEY POINTS : • Fluoroscopy during endovascular aortic aneurysm repair can impart a substantial radiation dose. • Radiation doses during EVAR are higher when using mobile/fixed angiographic systems. • Mobile C-arm fluoroscopy imparts a lower dose with an equivalent clinical outcome. • Procedures need to be dose-optimised when using mobile/fixed angiographic systems.