Sirolimus-Coated Balloon in Femoropopliteal Steno-Occlusive Disease: Efficacy, Safety, and 1-Year Outcomes. An All-Comers Registry.

PURPOSE: The aim of this study was to assess the efficacy and safety of the novel SLR (SELUTION sustained-limus-release) drug-coated balloon (DCB) in the treatment of the femoropopliteal steno-occlusive disease. MATERIALS AND METHODS: From February 2021 to March 2022, 80 consecutive patients (age: 69.5±8.23 years; total number of lesions: 80) with a steno-occlusive lesion of superficial femoral artery were enrolled at our center. A total of 60 patients (75%) had claudication, whereas 20 (25%) had chronic limb-threatening ischemia (CLTI). The mean lesion length was 171±82.22 mm. The primary efficacy outcome was primary patency at 12 months, defined as freedom from restenosis determined by a duplex ultrasound peak systolic velocity ratio ≤2.4. The secondary efficacy outcome was freedom from clinically-driven target lesion revascularization (CD-TLR) at 12 months. The primary safety outcome was a composite of freedom from device- and procedure-related mortality, major target limb amputation, and clinically-driven target lesion urgent revascularization (endovascular or bypass graft) at 30 days and 12 months. RESULTS: Device success was achieved in all 80 patients. One death on day 7 from cardiovascular complications was ruled procedure-related because it occurred within the first 30 days from the discharge. Two patients with CLTI experienced planned minor amputations of target limb, and one patient underwent urgent bypass graft of the target vessel for early occlusion at 60 days from the index procedure. The primary safety outcome was 98.7% and 97.5% at 30 days and 12 months, respectively. At 1 year, primary patency was 86.3%, and freedom from CD-TLR was 96.2%. CONCLUSION: These findings suggest that using a novel sirolimus-coated balloon is a safe and effective treatment option for femoropopliteal steno-occlusive lesions in a variety of clinical and anatomical settings. These results will need to be confirmed by long-term follow-up and randomized controlled trials. CLINICAL IMPACT: In femoropopliteal steno-occlusive lesions paclitaxel drug-coated devices have been proved to be able to achieve a better vessel patency during follow-up compared with uncoated balloon, but according to a recent meta-analysis they may carry an elevated risk of late mortality. Sirolimus results in a wider therapeutic range with a 3-fold higher margin of safety. Sirolimus coated devices have recently been proposed as an alternative. This study suggests that using a novel sirolimus-coated balloon is a safe and effective treatment option for femoropopliteal steno-occlusive lesions.

Assessing the impact of transcatheter aortic valve replacement on myocardial work indices and left ventricular diastolic function in aortic valve stenosis patients.

BACKGROUND: Aortic valve stenosis (AS) is the most common valvular heart disease worldwide. When timely intervention is performed, aortic valve replacement can improve patients' quality and duration of life. Load-independent left ventricular (LV) functional assessments, such as myocardial work indices (MWIs) and LV diastolic function parameters, could help clinicians decide on the optimal timing of intervention. AIMS: To evaluate the reliability of MWI in AS patients and the changes in MWI and LV diastolic function after transcatheter aortic valve replacement (TAVR). METHODS: We enrolled 53 consecutive patients with severe AS undergoing TAVR admitted between March 2021 and November 2021. MWIs and LV diastolic function were assessed before and after TAVR for each patient. RESULTS: All MWIs and LV diastolic function indices improved after TAVR. The degree of MWIs improvement was higher in patients with lower prior-TAVR MWI values, while the more severe the impairment of diastolic function, the greater the post-TAVR benefit. CONCLUSION: The introduction of myocardial work parameters into the routine assessment of patients with AS could improve our understanding of cardiac performance and aid in identifying the optimal timing for surgical or percutaneous treatment.

Rhinocerebral Mucormycosis with Orosinusal Involvement: Diagnostic and Surgical Treatment Guidelines.

BACKGROUND: Rhinocerebral mucormycosis is a rare, rapidly progressive and potentially lethal disease almost exclusively affecting immunocompromised hosts or patients with metabolic disorders, such as poorly controlled diabetes mellitus. METHODS: This work is aimed to describe five cases of rhinocerebral mucormycosis to review and possibly define diagnostic and surgical treatment guidelines. In all the patients, surgical debridement, systemic and local antifungal therapy, and oral rehabilitation using filling prostheses were performed. RESULTS: None of the patients revealed recurrence of the infection, as confirmed by radiological and clinical long term follow up. CONCLUSION: Given the lethal nature of the disease, the authors underline the importance of early diagnosis and of a multidisciplinary approach in order to undertake correct surgical and medical treatments, while keeping the underlying disease under control.

No-reflow phenomenon: pathophysiology, diagnosis, prevention, and treatment. A review of the current literature and future perspectives.

No-reflow is responsible for 40% of the primary percutaneous coronary intervention without complete myocardial reperfusion despite successful reopening of the infarct-related artery. This review describes the main pathophysiological mechanisms of no-reflow, its clinical manifestation, including the strong association with increased in-hospital mortality, malignant arrhythmias, and cardiac failure as well as the diagnostic methods. The latter ranges from simple angiographic thrombolysis in myocardial infarction grade score to more complex angiographic indexes, imaging techniques such as myocardial contrast echo or cardiac magnetic resonance, and surrogate clinical end points such as ST-segment resolution. This review also summarizes the strategies of prevention and treatment of no-reflow, considering the most recent studies results regarding medical therapy and devices.