Effect of a multidisciplinary team approach in patients with diabetic foot ulcers on major adverse limb events (MALEs): systematic review and meta-analysis for the development of the Italian guidelines for the treatment of diabetic foot syndrome.

The treatment of patients with diabetic foot ulcers (DFUs) is extremely complex, requiring a comprehensive approach that involves a variety of different healthcare professionals. Several studies have shown that a multidisciplinary team (MDT) approach is useful to achieve good clinical outcomes, reducing major and minor amputation and increasing the chance of healing. Despite this, the multidisciplinary approach is not always a recognized treatment strategy. The aim of this meta-analysis was to assess the effects of an MDT approach on major adverse limb events, healing, time-to-heal, all-cause mortality, and other clinical outcomes in patients with active DFUs. The present meta-analysis was performed for the purpose of developing Italian guidelines for the treatment of diabetic foot with the support of the Italian Society of Diabetology (Società Italiana di Diabetologia, SID) and the Italian Association of Clinical Diabetologists (Associazione Medici Diabetologi, AMD). The study was performed using the Grading of Recommendations Assessment, Development, and Evaluation approach. All randomized clinical trials and observational studies, with a duration of at least 26 weeks, which compared the MDT approach with any other organizational strategy in the management of patients with DFUs were considered. Animal studies were excluded. A search of Medline and Embase databases was performed up until the May 1st, 2023. Patients managed by an MDT were reported to have better outcomes in terms of healing, minor and major amputation, and survival in comparison with those managed using other approaches. No data were found on quality of life, returning-to-walking, and emergency admission. Authors concluded that the MDT may be effective in improving outcomes in patients with DFUs.

Bypass surgery versus endovascular revascularization for occlusive infrainguinal peripheral artery disease: a meta-analysis of randomized controlled trials for the development of the Italian Guidelines for the treatment of diabetic foot syndrome.

To report a review and meta-analysis of all randomized controlled trials (RCTs) comparing bypass surgery (BS) and endovascular treatment (ET) in infrainguinal peripheral arterial disease (PAD) for several endpoints, such as major and minor amputation, major adverse limb events (MALEs), ulcer healing, time to healing, and all-cause mortality to support the development of the Italian Guidelines for the Treatment of Diabetic Foot Syndrome (DFS). A MEDLINE and EMBASE search was performed to identify RCTs, published since 1991 up to June 21, 2023, enrolling patients with lower limb ischemia due to atherosclerotic disease (Rutherford I-VI). Any surgical BS or ET was allowed, irrespective of the approach, route, or graft employed, from iliac to below-the-knee district. Primary endpoint was major amputation rate. Secondary endpoints were amputation-free survival major adverse limb events (MALEs), minor amputation rate, all-cause mortality, ulcer healing rate, time to healing, pain, transcutaneous oxygen pressure (TcPO2) or ankle-brachial index (ABI), quality of life, need for a new procedure, periprocedural serious adverse events (SAE; within 30 days from the procedure), hospital lenght of stay, and operative time. Twelve RCTs were included, one enrolled two separate cohorts of patients, and therefore, the studies included in the analyses were 13. Participants treated with ET had a similar rate of major amputations to participants treated with BS (MH-OR 0.85 [0.60, 1.20], p = 0.36); only one trial reported separately data on patients with diabetes (N = 1), showing no significant difference between ET and BS (MH-OR: 0.67 [0.09, 5.13], p = 0.70). For minor amputation, no between-group significant differences were reported: MH-OR for ET vs BS: 0.83 [0.21, 3.30], p = 0.80). No significant difference in amputation-free survival between the two treatment modalities was identified (MH-OR 0.94 [0.59, 1.49], p = 0.80); only one study reported subgroup analyses on diabetes, with a non-statistical trend toward reduction in favor of ET (MH-OR 0.62 [0.37, 1.04], p = 0.07). No significant difference between treatments was found for all-cause mortality (MH-OR for ET vs BS: 0.98 [0.80, 1.21], p = 0.88). A significantly higher rate of MALE was reported in participants treated with ET (MH-OR: 1.44 [1.05, 1.98], p = 0.03); in diabetes subgroup analysis showed no differences between-group for this outcome (MH-OR: 1.34 [0.76, 2.37], p = 0.30). Operative duration and length of hospital stay were significantly shorter for ET (WMD: - 101.53 [- 127.71, - 75.35] min, p < 0.001, and, - 4.15 [- 5.73, - 2.57] days, p < 0.001 =, respectively). ET was associated with a significantly lower risk of any SAE within 30 days in comparison with BS (MH-OR: 0.60 [0.42, 0.86], p = 0.006). ET was associated with a significantly higher risk of reintervention (MH-OR: 1.57 [1.10, 2.24], p = 0.01). No significant between-group differences were reported for ulcer healing (MH-OR: 1.19 [0.53, 2.69], p = 0.67), although time to healing was shorter (- 1.00 [0.18, 1.82] months, p = 0.02) with BS. No differences were found in terms of quality of life and pain. ABI at the end of the study was reported by 7 studies showing a significant superiority of BS in comparison with ET (WMD: 0.09[0.02; 0.15] points, p = 0.01). The results of this meta-analysis showed no clear superiority of either ET or BS for the treatment of infrainguinal PAD also in diabetic patients. Further high-quality studies are needed, focusing on clinical outcomes, including pre-planned subgroup analyses on specific categories of patients, such as those with diabetes and detailing multidisciplinary team approach and structured follow-up.

Development of the Italian clinical practice guidelines for the treatment of diabetic foot syndrome: design and methodological aspects.

AIMS: Diabetic foot syndrome (DFS) and its complications are a growing public health concern. The Italian Society of Diabetology (SID) and the Italian Association of Clinical Diabetologists (AMD), in collaboration with other scientific societies, will develop the first Italian guidelines for the treatment of DFS. METHODS: The creation of SID/AMD Guidelines is based on an extended work made by 19 panelists and 12 members of the Evidence Review Team. Grading of Recommendations, Assessment, Development and Evaluations (GRADE) methodology has been used to decide aims, reference population, and target health professionals. Clinical questions have been created using PICO (Patient, Intervention, Comparison, Outcome) conceptual framework. The definition of questions has been performed using a two-step web-based Delphi methodology, a structured technique aimed at obtaining by repeated rounds of questionnaires a consensus opinion from a panel of experts in areas wherein evidence is scarce or conflicting, and opinion is important. RESULTS: The mean age of panelists (26.3% women) was 53.7 ± 10.6 years. The panel proposed 34 questions. A consensus was immediately reached for all the proposed questions, 32 were approved and 2 were rejected. CONCLUSIONS: The areas covered by clinical questions included diagnosis of ischemia and infection, treatment of ischemic, neuropathic, and infected ulcers, prevention of foot ulceration, organization and education issues, and surgical management. The PICO presented in this paper are designed to provide indications for healthcare professionals in charge of diabetic foot treatment and prevention, primarily based on clinical needs of people with diabetic foot syndrome and considering the existing organization of health care.

Contrast-Enhanced Ultrasound (CEUS) in Non-Traumatic Abdominal Emergencies.

Conventional ultrasound imaging (US) is the first-line investigation in acute non-traumatic abdominal emergencies, but sometimes it needs further examinations, such as computed tomography (CT), to reach a certain diagnosis. Contrast-enhanced ultrasound (CEUS), through injection of contrast medium, may provide the radiologist with additional information that could not be investigated with baseline US. It could help reach a diagnosis and rapidly determine the proper therapy in an emergency setting. The purpose of this review is to explain and illustrate the various possibilities and limitations of CEUS in acute non-traumatic abdominal diseases, in particular acute inflammation, parenchymal infarcts, and hemorrhages.

Radiation dose among different cardiac and vascular invasive procedures: The RODEO study.

BACKGROUND: Interventional radiology and cardiology procedures contribute significantly to the collective dose of radiation exposure from medical interventions. Recent and dedicated studies comparing directly these procedures in term of patient radiation exposure are lacking. Our aim was to compare radiation exposure among different interventional procedures performed under fluoroscopic guidance. METHODS: The RODEO study (NCT: 02972736) is an international observational retrospective multicenter study enrolling all patients undergoing diagnostic or interventional procedures performed by different interventional operators (i.e. radiologists, interventional cardiologists or electrophysiologists) in 6 centers, without exclusion criteria. The primary end-point of the study was the comparison of dose area product (DAP) among interventional cardiology, electrophysiology or interventional radiology procedures. RESULTS: A total of 17,711 procedures were included in the study: 13,522 interventional cardiology, 2352 electrophysiology and 1864 interventional radiology procedures. The highest DAP values were observed for interventional radiology procedures (74Gy∗cm2 [Interquartile range 27-178Gy∗cm2]), followed by interventional cardiology (40Gy∗cm2 [22-78Gy∗cm2]) and electrophysiology procedures (13Gy∗cm2 [4-44Gy∗cm2], p<0.0001). In term of specific procedures, the highest DAP values were observed in structural or valvular cardiac procedures (134Gy∗cm2 [51-260Gy∗cm2]) whereas the lowest DAP values in pacemaker insertion (11Gy∗cm2 [4-28Gy∗cm2]). CONCLUSION: In this large multicenter study, the highest radiation exposure was observed in procedures performed by interventional radiologists. However, among specific procedures, structural or valvular cardiac procedures were associated with the highest radiation exposure.

Third-line treatment of colorectal liver metastases using DEBIRI chemoembolization.

To evaluate safety, efficacy of drug-eluting beads with irinotecan (DEBIRI) on local response and survival of patients affected by colorectal liver metastases (CRLM) progressing during or after second line was evaluated. Sixty-two patients, with colorectal liver metastases, not suitable for surgery or thermal ablation treatments, progressing during or within 6 month from the end of second-line chemotherapy, were treated with DEBIRI chemoembolization between February 2009 and July 2014. CRLM were histologically confirmed. Exclusion criteria were considered. The DEBIRI technique consists in intrahepatic embolization of metastases with non-absorbable beads (75-150 µm and 100-300 µm) preloaded with irinotecan, carried near tumour using a selective catheterization of the right or of the left hepatic artery. To control pain associated with treatment, we use a specific schedule. Efficacy of treatment, defined as lack of disease progression and reduction in size of metastasis according to RECIST 1.1 criteria, was evaluated after two treatments with contrast-enhanced computed tomography (CT) at 4 months. If necessary, more treatments are repeated. A total of 191 procedures were performed. No intra-/peri-procedural death occurred. Pain and post-embolization syndrome were generally controlled by medications. Overall, the efficacy of treatment, evaluated in terms of stability and remission of the disease, was 37.1%. In our experience, DEBIRI technique results as a safe and effective procedure, with good intra- and peri-procedural tolerability.

Multiple Pancreatoduodenal Artery Arcade Aneurysms Associated with Celiac Axis Root Segmental Stenosis Presenting as Aneurysm Rupture.

A 57-year-old woman was admitted to our unit suffering from hemorrhagic shock and upper abdominal pain. An enhanced computerized tomography (CT) scan evidenced a large retroperitoneal hematoma due to visceral arteries aneurysm rupture and a significant celiac axis root segmental stenosis due to median arcuate ligament compression. A selective splanchnic arteries angiography showed 3 saccular pancreaticoduodenal artery arcade aneurysm (PDAAs), 2 in the inferior posterior pancreaticoduodenal artery, and 1 smaller in the superior anterior pancreaticoduodenal artery. The largest aneurysm showed evident rupture signs. Both inferior PDAAs were successfully treated via endovascular coil embolization. The celiac trunk stenosis and small inferior PDAA did not require treatment. A CT scan control at 1-year follow-up did not reveal any new PDAAs. In cases of celiac artery trunk (CAT) steno-occlusive lesions, multiple aneurysms can develop in the pancreaticoduodenal arcade. PDAAs should be treated because of high rupture risk, regardless of diameter. Although endovascular treatment via coil embolization represents the treatment of choice nowadays, a simultaneous treatment of the associated CAT lesions is still debated. However, in cases of aneurysm embolization alone, one cannot exclude that other PDAAs might develop in these patients in the future. Close monitoring and accurate long-term follow-up is highly recommended in these cases.