Evaluation of Clinical Outcomes After Revascularization in Patients With Chronic Limb-Threatening Ischemia: Results From a Prospective National Cohort Study (RIVALUTANDO)

We evaluated the outcomes of revascularization in patients with chronic limb-threatening ischemia (CLTI) treated in real-world settings. This is a prospective multicenter cohort study with 12-month follow-up enrolling patients (n = 287) with CLTI undergoing open, endovascular, or hybrid lower extremity revascularization. The primary end point was amputation-free survival (AFS) at 12 months. Cox proportional analysis was used to determine independent predictors of amputation and restenosis. At 30 days, major adverse cardiovascular and major adverse limb events (MALE) rates were 3.1% and 2.1%, respectively. At 1 year, the overall survival rate was 88.8%, the AFS was 86.6%, and the primary patency was 70.5%. Freedom from MALE was 62.5%. After multivariate analysis, smoking (hazard ratio [HR] = 2.2, P = 0.04), renal failure (HR = 2.3, P = 0.03), Rutherford class (≥5) (HR = 3.2, P = 0.01), and below-the-knee disease (HR = 2.0, P = 0.05) were significant predictors of amputation; iloprost infusion (>10 vials) (HR = 0.64, P = 0.05) was a significant protective factor. Cilostazol administration (HR = 0.77, P = 0.05) was a significant protective factor for restenosis. Results from this prospective multicenter registry offer a consistent overview of clinical outcomes of CLTI patients at 1 year when adequately revascularized. Medical treatment, including statins, cilostazol and iloprost, were associated with improved 1-year freedom from restenosis and amputation.

Impact of COVID-19 on outpatient therapy with iloprost for Systemic Sclerosis digital ulcers

Introduction and objectivesThe outbreak of COVID-19 epidemic imposed temporary changes in the management of patients with chronic diseases. We analyzed the impact of COVID-19 epidemic in patients with Systemic Sclerosis (SSc) receiving intravenous iloprost infusions for digital ulcers (DU) treatment.MethodsDuring the epidemic, iloprost infusion therapy in our Hospital was guaranteed; patients were regularly contacted by telephone before the scheduled infusions. DU were evaluated with DUCAS (DU Clinical Assessment Score).ResultsBetween 20th February and 31st May 2020, 47/64 SSc patients did not receive at least one of the scheduled infusions, for patients fear and/or logistical difficulties (43 cases), COVID-19 (2), or other intercurrent diseases (2). At the last evaluation before 20th February DUCAS was not different between patients who stopped the therapy and those who continued it. The 2 groups had similar rate of new DU during the emergency period, but DUCAS slightly increased during therapy discontinuation, decreasing after resuming it. After COVID-19, one patient underwent a fingertip sub-amputation, and an 85-year-old male with multiple comorbidities died for complications related to the infection.ConclusionsMost SSc patients briefly discontinued iloprost therapy, without increase of new DU number, but with a slight increase of their severity. The regular telephonic contact helped the management that, although not optimal, was adapted to the needs of the individual patient during this emergency period. DUCAS proved to be a useful tool for rheumatologists. COVID-19 had serious consequences in the two patients who contracted it.

Iloprost infusion through elastomeric pump in the treatment of Raynaud’s phenomenon and digital ulcers

Introduction: Systemic sclerosis is a systemic autoimmune disease characterized by microangiopathy and fibroblast dysfunction resulting in fibrosis of the skin and internal organs. Raynaud’s phenomenon and digital ulcers are the main clinical features of vascular involvement. Treatment with iloprost is recommended to reduce the frequency and severity of Raynaud’s phenomenon attacks and to heal active digital ulcer. Classical forms of treatment require admission to a ward or day-hospital unit to ensure safety during infusion, causing disruption of the patient’s normal daily life and resulting in significant costs with hospitalization. Nowadays, new portable devices, of which the elastomeric pump is an example, are becoming available in order to avoid hospitalization. Case reports: We describe five cases of patients with systemic sclerosis or mixed connective tissue disease and severe Raynaud’s phenomenon/critical ischaemia or active digital ulcers that were successfully treated with iloprost infusion through elastomeric pump without experiencing any side effects. We present our unit’s protocol for ambulatory infusion. Discussion/conclusion: Our case reports and a brief review of literature prove that iloprost infusion through elastomeric pump is safe, easy and well tolerated and might even improve patient compliance with treatment. Meanwhile, it may also decrease the economic burden of hospitalization with these patients.

Augmentation of arterial blood velocity with electrostimulation in patients with critical limb ischemia unsuitable for revascularization

Aim This pilot study aimed to reveal whether combination of electrostimulation with iloprost treatment achieves better results compared to iloprost alone in patients with critical limb ischemia. Material and methods Patients were randomized into Group 1 ( n = 11, mean age: 65.3 ± 4.2 years, received iloprost infusion protocol alone) or Group 2 ( n = 11, mean age: 62.9 ± 6.7, received iloprost infusion plus standardized protocol of peroneal nerve electrostimulation). Electrostimulation was delivered with 1 Hz frequency, 27 mA current, and 200 ms pulse width. Peak blood flow velocities in the anterior and posterior tibialis arteries were measured with duplex ultrasound. Results There was a slight insignificant increase in blood velocity in anterior tibialis artery in Group 1 (from 17.6 ± 13.0 to 18.6 ± 13.1, p = 0.57), whereas the increase in Group 2 was marked (from 23.8 ± 18.3 to 32.2 ± 19.7, p = 0.01). Blood velocity in posterior tibialis artery also increased in both groups, but it was not of statistical significance. No significant difference was found between two groups in regard to final pulse oximetry oxygen saturation levels. Conclusion Electrostimulation of the peroneal nerve caused a substantial increase in anterior tibialis artery blood velocity when used as an adjunct to medical therapy in patients with critical limb ischemia.

The Effect of Iloprost and N-Acetylcysteine on Skeletal Muscle Injury in an Acute Aortic Ischemia-Reperfusion Model: An Experimental Study

Objective. The objective of this study was to examine the effects of iloprost and N-acetylcysteine (NAC) on ischemia-reperfusion (IR) injuries to the gastrocnemius muscle, following the occlusion-reperfusion period in the abdominal aorta of rats.Materials and Methods. Forty male Sprague-Dawley rats were randomly divided into four equal groups.Group 1: control group. Group 2 (IR): aorta was occluded. The clamp was removed after 1 hour of ischemia. Blood samples and muscle tissue specimens were collected following a 2-hour reperfusion period.Group 3 (IR + iloprost): during a 1-hour ischemia period, iloprost infusion was initiated from the jugular catheter. During a 2-hour reperfusion period, the iloprost infusion continued.Group 4 (IR + NAC): similar to the iloprost group.Findings. The mean total oxidant status, CK, and LDH levels were highest in Group 2 and lowest in Group 1. The levels of these parameters in Group 3 and Group 4 were lower compared to Group 2 and higher compared to Group 1 (P<0.05). The histopathological examination showed that Group 3 and Group 4, compared to Group 2, had preserved appearance with respect to hemorrhage, necrosis, loss of nuclei, infiltration, and similar parameters.Conclusion. Iloprost and NAC are effective against ischemia-reperfusion injury and decrease ischemia-related tissue injury.