Standard Balloon Angioplasty Versus Serranator Serration Balloon Angioplasty for the Treatment of Below-the-Knee Artery Occlusive Disease: A Single-Center Subanalysis From the PRELUDE-BTK Prospective Study.

BACKGROUND: Endovascular interventions in infrapopliteal occlusive artery disease are becoming more complex, and this frequently tests the standard method of treatment, plain old balloon angioplasty (POBA). The potential that serration angioplasty could produce a more acceptable tibial artery lumen was assessed in this study. AIM: The aim of this single-center subgroup analysis was to compare acute angiographic results after endovascular treatment using the Serranator serration balloon catheter in patients participating in the PRELUDE-BTK trial with POBA of the infrapopliteal arteries. A secondary objective was to assess post-treatment hemodynamic improvements. METHODS: Our center enrolled 15 subjects and treated 17 lesions within the multicenter prospective core laboratory-adjudicated PRELUDE-BTK study. A 25 lesions analyzed separately were treated with POBA and then compared with the Serranator subset. In both cohorts, lesions were treated with either plain angioplasty or Serranator as a stand-alone therapy; subsequent methods, such as drug elution technologies, were not used. Acute angiographic results were analyzed by the SynvaCor angiographic core laboratory. To assess volumetric flow rates, data were analyzed with a fluid flow simulation software and compared against Poiseuille's Law. RESULTS: Final residual stenosis was 17.2%±8.2% in the Serranator group versus 33.7%±15.7% in the POBA group. The mean lumen diameter (MLD) gain for the Serranator group and the POBA group was 1.64±0.41 mm and 1.33±0.63 mm, respectively. The average atmospheric balloon inflation pressure was 5 ATM in the Serranator group versus 9 ATM in the POBA group. Neither group required a bailout stent; however, it was notable that there were significantly more chronic total occlusions (CTOs) treated in the Serranator group at 41.2% versus 12% in the POBA group. Regarding the effectiveness in improving hemodynamic blood flow for non-CTO lesions, the calculated average ratio of post-treatment to pre-treatment flow rates in the Serranator group was 238% than that for the POBA group. For CTO cases where pre-treatment flow rate was zero, final residual stenosis was used as the parameter for comparison. The Serranator group showed a 62% improvement in final residual stenosis over POBA. CONCLUSION: Endovascular treatment of the infrapopliteal arteries by use of the Serranator serration balloon provides a novel and promising method of action compared with standard balloon angioplasty and, thus, may have a leading role in complex below-the-knee arterial lesions. CLINICAL IMPACT: The Serranator device might help to adequately address issues with conventional routine techniques for the treatment of complex lesions in infrapopliteal arteries in patients with advanced stages of PAD and critical limb ischemia. Integrating modern technologies such as the Serranator balloon catheter into clinical routine is mandatory in order to gain a more favorable outcome in these severely diseased patients and, particularly, to reduce mortality and morbidity.

Long-Term Outcomes of the 150 mm Drug-Coated Balloon Cohort from the IN.PACT Global Study.

PURPOSE: Data on the long-term safety and effectiveness of drug-coated balloons (DCBs) for the treatment of long femoropopliteal atherosclerotic lesions in the real-world setting are rare. This study reports 3 year and 5 year outcomes of the pre-specified 150 mm balloon sub-cohort of the IN.PACT Global Study. METHODS: The IN.PACT Global Study was a prospective, multicentre, international, single-arm study evaluating the performance of the IN.PACT Admiral DCB in real-world patients with femoropopliteal atherosclerotic disease. This pre-specified 150 mm DCB cohort analysis comprised 107 participants (111 lesions) with all target lesions treated with at least one 150 mm DCB. RESULTS: Mean lesion length was 20.3 ± 9.2 cm; 18.0% had in-stent restenosis, 58.6% were totally occluded, and 17.1% were severely calcified. Through 60 months, the Kaplan-Meier estimate of freedom from clinically driven target lesion revascularization (CD-TLR) was 72.7% [95% confidence interval (CI):62.4%-80.5%]. The safety composite endpoint (freedom from device/procedure-related death through 30 days; freedom from target limb major amputation and clinically driven target vessel revascularization through 5 years) was 70.5%. The cumulative incidence of major amputation was 1.0% and all-cause mortality was 18.4% through 60 months. Freedom from CD-TLR rates in the provisional stented and non-stented subgroups through 36 months were 64.0% [95% CI: 46.1%-77.3%] and 81.9% [95% CI: 69.7%-89.6%] (log-rank p = 0.074), respectively. CONCLUSIONS: The results demonstrate sustained long-term safety of the 150 mm IN.PACT Admiral DCB for long femoropopliteal atherosclerotic lesions in real-world patients. In particular, the results show that DCB angioplasty is an effective revascularization modality in long complex lesions. CLINICALTRIALS: gov identifier: NCT01609296. LEVEL OF EVIDENCE: Level 3, Cohort Study.

Thrombotic Complications after COVID-19 Vaccination: Diagnosis and Treatment Options.

Coronavirus disease 2019 (COVID-19) vaccines were developed a few months after the emergence of the pandemic. The first cases of vaccine-induced thrombotic complications after the use of adenoviral vector vaccines ChAdOx1 nCoV-19 by AstraZeneca, and Ad26.COV2.S by Johnson & Johnson/Janssen, were announced shortly after the initiation of a global vaccination program. In these cases, the occurrence of thrombotic events at unusual sites-predominantly located in the venous vascular system-in association with concomitant thrombocytopenia were observed. Since this new entity termed vaccine-induced thrombotic thrombocytopenia (VITT) shows similar pathophysiologic mechanisms as heparin-induced thrombocytopenia (HIT), including the presence of antibodies against heparin/platelet factor 4 (PF4), standard routine treatment for thrombotic events-arterial or venous-are not appropriate and may also cause severe harm in affected patients. Thrombotic complications were also rarely documented after vaccination with mRNA vaccines, but a typical VITT phenomenon has, to date, not been established for these vaccines. The aim of this review is to give a concise and feasible overview of diagnostic and therapeutic strategies in COVID-19 vaccine-induced thrombotic complications.

Rituximab as a Treatment Option after Autologous Hematopoietic Stem Cell Transplantation in a Patient with Systemic Sclerosis.

Systemic sclerosis (SSc) is an intractable autoimmune disease characterized by vasculopathy and organ fibrosis. Autologous hematopoietic stem cell transplantation (AHSCT) should be considered for the treatment of selected patients with rapid progressive SSc at high risk of organ failure. It, however, remains elusive whether immunosuppressive therapies such as rituximab (RTX) are still necessary for such patients after AHSCT, especially in those with bad outcomes. In the present report, a 43-year-old man with diffuse cutaneous SSc received AHSCT. Despite AHSCT, SSc further progressed with progressive symptomatic heart failure with newly developed concomitant mitral and tricuspid valve insufficiency, thus the patient started on RTX 8 months after AHSCT. Shortly after initiation of RTX, clinical symptoms and organ functions ameliorated subsequently. Heart valve regurgitations were reversible after initiation of RTX treatment. Currently, the patient remains in a stable condition with significant improvement of clinical symptoms and organ functions. Reporting about therapies after AHSCT in SSc is a very important issue, as randomized controlled trials are lacking, and therefore this report adds to evidence that RTX can be considered as a treatment option in patients with SSc that do not respond to AHSCT.

The White Blood Cell Count to Mean Platelet Volume Ratio for the Prediction of Chronic Limb-Threatening Ischemia in Lower Extremity Artery Disease.

: Background: The white blood cell count to mean platelet volume ratio (WMR) is increasingly gaining importance as a promising prognostic marker in atherosclerotic disease, but data on lower extremity artery disease (LEAD) are not yet available. The principle aim of this study was to assess the association of the WMR with the occurrence of CLTI (chronic limb-threatening ischemia) as the most advanced stage of disease. METHODS: This study was performed as a retrospective analysis on 2121 patients with a diagnosis of LEAD. Patients were admitted to the hospital for the reason of LEAD and received conservative or endovascular treatment. Blood sampling, in order to obtain the required values for this analysis, was implemented at admission. Statistical analysis was conducted by univariate regression in a first step and, in case of significance, by multivariate regression additionally. RESULTS: Multivariate regression revealed an increased WMR (p < 0.001, OR (95%CI) 2.258 (1.460-3.492)), but also advanced age (p < 0.001, OR (95%CI) 1.050 (1.040-1.061)), increased CRP (p < 0.001, OR (95%CI) 1.010 (1.007-1.014)), and diabetes (p < 0.001, OR (95%CI) 2.386 (1.933-2.946)) as independent predictors for CLTI. CONCLUSIONS: The WMR presents an easily obtainable and cost-effective parameter to identify LEAD patients at high risk for CLTI.