Cardiva Catalyst is safe and effective device in achieving local hemostasis after percutaneous diagnostic procedures and interventions performed under bivalirudin anticoagulation. The use of this device with an appropriate protocol facilitates same-day discharge.

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IMPORTANCEIntravitreal bevacizumab effectively treats severe retinopathy of prematurity (ROP), but it enters the bloodstream and may reduce serum vascular endothelial growth factor (VEGF), potentially causing detrimental effects on developing organs in the premature infant.OBJECTIVE To evaluate the association of intravitreal bevacizumab with plasma bevacizumab and VEGF concentrations at 2 and 4 weeks after predefined, de-escalating doses of intravitreal bevacizumab were administered to infants with severe ROP. DESIGN, SETTING, AND PARTICIPANTSThis phase 1 dose de-escalation case series study was conducted at 10 US hospitals of ophthalmology institutions from May 21, 2015, to May 7, 2019. Blood samples were collected 2 and 4 weeks after intravitreal bevacizumab injection. Participants included 83 premature infants with type 1 ROP in 1 or both eyes and no previous ROP treatment. Data were analyzed from April 2017 to August 2021.INTERVENTIONS Study eyes received a single bevacizumab injection of 0.250 mg, 0.125 mg, 0.063 mg, 0.031 mg, 0.016 mg, 0.008 mg, 0.004 mg, or 0.002 mg. When the fellow eye required treatment, one dose higher was administered. Total dose administered at baseline was defined as the sum of doses given to each eye within 3 days of initial study-eye injection. MAIN OUTCOMES AND MEASURESPlasma bevacizumab concentration at 2 and 4 weeks after injection and the percentage change in plasma VEGF concentrations from pretreatment levels. RESULTS A total of 83 infants (mean [SD] age, 25 [2] weeks; 48 boys [58%]) were included in this study. Higher doses of bevacizumab administered at baseline were associated with higher plasma bevacizumab concentrations at 2 weeks (ρ, 0.53; 95% CI, 0.31-0.70) and 4 weeks (ρ, 0.44; 95% CI, 0.18-0.64). Plasma VEGF concentrations decreased by 50% or more from pretreatment levels in 40 of 66 infants (61%) at 2 weeks and 31 of 61 infants (51%) at 4 weeks, but no association was observed between the total dose of bevacizumab administered at baseline and percentage change in plasma VEGF concentrations 2 weeks (ρ, −0.04; 95% CI, −0.28 to 0.20) or 4 weeks (ρ, −0.17; 95% CI, −0.41 to 0.08) after injection.CONCLUSIONS AND RELEVANCE Results of this phase 1 dose de-escalation case series study revealed that bevacizumab doses as low as 0.002 mg were associated with reduced plasma VEGF levels for most infants at 2 and 4 weeks after intravitreal administration; however, no association was observed between total bevacizumab dose administered and reductions in plasma VEGF levels from preinjection to 2 weeks or 4 weeks. Additional studies are needed to evaluate the long-term effects of low-dose bevacizumab on neurodevelopment and retinal structure.

CAS is safe and successful procedure with low early and long-term adverse events. Special attention should be put on patients with bilateral and left ICA stenoses. If possible, longer stents should be applied.

A b s t r a c tBackground: Currently the majority of coronary and peripheral interventions are performed with an overnight stay. This increases the cost and does not reduce logistic constraints on hospital resources. We hypothesised that by combining bivalirudin with vascular closure devices we can safely discharge patients on the same day after percutaneous coronary intervention (PCI) and percutaneous transluminal angioplasty (PTA) without increasing their risk of bleeding. Aim:To evaluate the safety and the feasibility of same-day discharge after PCI and PTA using bivalirudin and vascular closure devices.Methods: This is a retrospective analysis of 833 consecutive patients who underwent percutaneous procedures in our centre between January 2007 and February 2010. The population was divided into interventional and diagnostic arms. All interventions were done with use of bivalirudin for anticoagulation and vascular closure devices for achieving haemostasis. Haemostasis in the diagnostic cohort was achieved with standard manual compression. The mean time of observation was 30 days. The mean age of patients was 64.3 years. The primary endpoint was any bleeding event meeting GUSTO criteria. The secondary endpoints included local vascular complications, major adverse cardiac and cerebrovascular events, time to ambulation and discharge, as well as need for overnight hospitalisation. Results:In 30-day observation the primary endpoint occurred in 4.0% of patients in the interventional group and in 2.6% of patients in the diagnostic group (p = 0.31). The frequency of local vascular complications was higher in the interventional group although it was not statistically significant (3.1% vs. 2.9%; p = 0.33). Patients from the interventional group were ambulated sooner compared to the diagnostic group (117.5 vs. 131 min; p = 0.003). Time to discharge was 316.4 ± 38.7 min and 214.2 ± 23.4 min for interventional and diagnostic procedures, respectively (p < 0.001).Conclusions: PCI and PTA in the selected group of patients, with use of bivalirudin and vascular closure devices, do not appear to have increased risk of post-procedural events when compared to diagnostic procedures, and can be done safely without the need for an overnight stay.

Percutaneous coronary intervention (PCI) utilizing drug-eluting stents is becoming a very common revascularization technique in the dialysis cohort; therefore, we sought to identify the impact of dialysis on outcomes in this group of patients. This is a multicenter registry comparing results of 290 patients (186 with normal kidney function, 104 on dialysis) who underwent PCI with exclusive use of paclitaxel-eluting TAXUS stent. The primary endpoint was an assessment of major adverse cardiac events (MACE) at 1-and 2-year observation. Mean follow-up was 23.3 ± 6.1 months. Results at 12 months showed: MACE 11.8% vs. 7.7% (P = not significant [ns]), composite major adverse cardiac and cerebrovascular events (MACCE) 12.4% vs. 11.5% (P = ns), all-cause death 2.7% vs. 8.6% (P < 0.05), cardiac death 2.7% vs. 1.9% (P = ns), target vessel revascularization (TVR) 9.1% vs. 6.7% (P = ns), acute myocardial infarction (AMI) 3.8% vs. 2.9% (P = ns), cerebrovascular events (CVA) 0.5% vs. 1.0% (P = ns); and results at 24 months showed: MACE 17.7% vs. 18.3% (P = ns), MACCE 21.5% vs. 26.0% (P = ns), all-cause death 4.3% vs. 14.4% (P < 0.01), cardiac death 3.2% vs. 1.9% (P = ns), TVR 14.0% vs. 16.3% (P = ns), AMI 5.4% vs. 5.8% (P = ns), CVA 3.2% vs. 2.9% (P = ns) for non-endstage renal disease (ESRD) and dialysis group, respectively. Prior coronary artery bypass graft (CABG) was found to be single risk factor for MACE, TVR, and MACCE in patients with ESRD, while dialysis and prior CABG were found to be single risk factors for death in the entire population. PCI with TAXUS is a feasible procedure and presents promising results in dialysis-dependent patients.

SilverHawk Plaque Excision combined with aggressive pharmacotherapy in this presented high-risk population is associated with promising long-term outcomes that compare favorably with accepted standards of care.

A b s t r a c tThe subintimal angioplasty is one of the most frequent techniques used for total chronic occlusion (CTO) treatment. Nevertheless, this approach is limited by the lack of controlled re-entry into the true lumen of the target vessel. We present a case of a 85-yearold man with symptomatic CTO of the left superficial femoral artery (SFA). After initially unsuccessful subintimal recanalization with Confianza wire, Pioneer Plus Catheter with Intravascular Ultrasound Volcano system guidance were used for a true lumen re-entry. Finally lesion was treated with angioplasty and stents. Procedure was successful without complications, no residual stenosis was noted. The patient was discharged home four hours after procedure. The one day and three weeks follow up showed no vascular complications and the patient had no residual symptoms. The ankle-brachial index of the left extremity has improved from baseline 0.22 to 0.98.