Giant left ventricular inferior wall aneurysm as a late complication after myocardial infarction: A case report.

A case of a 64-year-old patient who was referred to interventional cardiology unit in order to qualify her to mitral valve repair is presented. Transthoracic echocardiography revealed a giant inferior wall basal aneurysm of the left ventricle (44 mm × 31 mm, 57 ml) and coronary angiography revealed chronic total occlusion of the proximal right coronary artery. The patient refused surgical treatment and was treated with pharmacotherapy alone. At 1 year follow-up, clear progression of the disease was observed. Based on this case study, we would cautiously suggest that in similar cases of large inferobasal wall aneurysms causing severe MR, OMT may be insufficient to prevent disease progression, and that early surgical intervention may be preferred.

Prospective Study of Serration Angioplasty in the Infrapopliteal Arteries Using the Serranator Device: PRELUDE BTK Study.

PURPOSE: The purpose was to evaluate the safety and efficacy of the Serranator percutaneous transluminal angioplasty serration balloon catheter in patients with infrapopliteal peripheral artery disease. MATERIALS AND METHODS: A prospective, multicenter, single-arm feasibility study in 46 patients with claudication or chronic limb-threatening ischemia, Rutherford Clinical Category (RCC) 3 to 5, that required treatment of the infrapopliteal arteries above the tibiotalar joint. The primary efficacy outcome was device success-successful insertion, balloon inflation and deflation, and removal of the device(s) with a final diameter stenosis of <50%. The primary safety endpoint was a composite of major adverse limb events (MALE) and perioperative death (POD) through 30 day postprocedure. Other outcomes were change in RCC and ankle-brachial index, wound healing, and clinically-driven target lesion revascularization (CD-TLR). A subset of 9 patients were further evaluated by optical coherence tomography (OCT) or intravascular ultrasound (IVUS) for the presence of serrations in treated lesions. Patient follow-up occurred at 30 days and 6 months. RESULTS: Forty-six patients received treatment with the Serranator device and 55 lesions were treated. Fifty-three lesions were deemed analyzable by the core lab with data and reported hereafter. Device success was 91.7% and freedom from MALE + POD through 30 days was 95.7%. Pretreatment stenosis of 82% was reduced to 21.8% and only 1 lesion (1.9%) required a bailout stent for a grade D dissection. The average maximum balloon inflation pressure was 6 atmospheres. Serrations were present in all treated lesions (n=10) in 9 patients imaged with OCT/IVUS as reviewed by the core laboratory. The RCC score improved by 1 or more level in 70% of patients at 6 months with 42% having a score of 0. The 6 month freedom from CD-TLR was 97.7%. CONCLUSION: Serranator treatment of infrapopliteal lesions showed excellent lumen gain with minimal evidence of arterial injury and low 6 month CD-TLR. Imaging by IVUS and OCT showed serrations without significant dissection, supporting the device's proposed mechanism of action.

Without more theory, psychology will be a headless rider.

We argue that Yarkoni's proposed solutions to the generalizability crisis are half-measures because he does not recognize that the crisis arises from investigators' underappreciation of the roles of theory in experimental research. Rather than embracing qualitative analysis, the research community should make an effort to develop better theories and work toward consistently incorporating theoretical results into experimental practice.

Microcrystalline paclitaxel-coated balloon for revascularization of femoropopliteal artery disease: Three-year outcomes of the randomized BIOPAC trial.

The aim of the BIOPAC trial was to determine long-term safety and efficacy of a novel microcrystalline paclitaxel-coated balloon (mcPCB) with a biocompatible polymer as an excipient in the treatment of occlusive femoropopliteal lesions. In this first-in-human prospective controlled randomized trial, 66 patients with femoropopliteal, symptomatic (Rutherford stages 2B to 5) occlusive arterial disease were randomized to either mcPCB (study group) or POBA (plain old balloon angioplasty) (control group) on a 1:1 basis. Late lumen loss (LLL) at 6 months was the primary endpoint of the study and serious adverse events (SAE: death, amputation, repeated revascularization) were considered a composite secondary endpoint. Routine angiography was scheduled for all study subjects at 6-month follow-up; outpatient appointments were scheduled at 12 and 36 months after intervention. At 6 months, the LLL was 63% lower in the mcPCB group compared to the POBA group (0.52 ± 1.2 vs 1.39 ± 1.1 mm; psup < 0.01). Binary restenosis occurred in 23% vs 52% of patients (p = 0.02). At 3 years, the prevalence of SAE was significantly lower in the mcPCB group (33.3 vs 63.3%; p = 0.02), which mainly resulted from a twofold reduction in target vessel revascularization rate (28.6 vs 59.3%; p = 0.02). The difference in mortality was nonsignificant (7.4 vs 14.3%; p = 0.42). Patients with mcPCB were less symptomatic and less likely to adhere to secondary prevention measures. In this pivotal trial, a novel mcPCB proved superior to POBA concerning LLL at 6-month follow-up, and SAE at 12 months. This result was sustained up to 3 years. There was no difference between groups regarding mortality. ClinicalTrials.gov Identifier: NCT02145065.

Clinical significance of mirror lesions in lower extremity arterial disease.

OBJECTIVE: The aim of this study was to investigate the clinical relevance of bilateral peripheral arterial disease (PAD) patterns. BACKGROUND: No prior study has evaluated the clinical significance of symmetrical lesion patterns, particularly the coexistence of same-level significant plaques in both lower extremities ("mirror lesions"). METHODS: We conducted a single-facility, primary data analysis involving 225 patients with symptomatic PAD. RESULTS: Eighty-two percent of the patients had bilateral lesions: 14.2% had femoropopliteal, 38.7% had infrapopliteal, and 27.1% had both femoropopliteal and infrapopliteal lesions. The lesions were found in the exact same arteries bilaterally in 24.9% of the patients, while 26.7% had a local mirror pattern limited to the femoropopliteal (13.7%) or infrapopliteal (12.9%) arteries. Having a lesion in an artery was a risk factor for occlusive disease of the corresponding artery on the other side. Patients presenting with critical limb ischemia (CLI) had a history of resting pain (17%), ulceration/gangrene (13%), or prior amputation (26%) of the contralateral limb. Patients with significant bilateral disease had unilateral false-negative ABI results in 11.6% of the cases. The arterial Doppler study results were unilaterally false-negative in 19.6% and bilaterally false-negative in 2.8% of the patients. CONCLUSIONS: Patients with known peripheral arterial disease need to have both limbs fully evaluated and monitored, even in cases with negative screening results. Mirror angiographic imaging is common and often accompanied by symptoms of claudication. Unilateral ischemia is a strong risk factor for contralateral disease. Patients with CLI are at high risk for occlusive lesions of the nonindex limb.

PRELUDE Prospective Study of the Serranator Device in the Treatment of Atherosclerotic Lesions in the Superficial Femoral and Popliteal Arteries.

PURPOSE: To evaluate the safety and efficacy of the Serranator Alto PTA Serration Balloon Catheter in subjects with peripheral artery disease in the superficial femoral and popliteal arteries. MATERIALS AND METHODS: A prospective, multicenter, single-arm feasibility study enrolled 25 patients (mean age 66 years; 18 men) to evaluate Serranator inflation and postinflation effects under monitoring by independent core laboratories. Inclusion criteria were claudication or ischemic rest pain, de novo lesions or native artery restenosis, >70% stenosis, lesion length <10 cm, and a reference vessel diameter of 4 to 6 mm. Chronic total occlusions (CTO) up to 6 cm in length were allowed (n=8). The primary safety endpoint was 30-day major adverse events. Primary efficacy outcome was device success with final diameter stenosis <50%. The secondary objective was to confirm the presence of serrations across the lesions using optical coherence tomography (OCT) or intravascular ultrasound (IVUS) following treatment in a subset of 10 subjects. Follow-up evaluations were conducted at 30 days and 6 months. RESULTS: Technical success of device delivery and retrieval was 100%. The primary safety endpoint was met, with no patients experiencing a major adverse event in the first 30 days. Pretreatment stenosis of 88% was reduced to 23%. One stent was implanted for grade D dissection in a CTO. The core laboratory-adjudicated primary patency was 100% at 1 month and 64% at 6 months. Serrations were confirmed in all 10 OCT/IVUS images reviewed by the core laboratory. The Rutherford category showed significant and sustained improvement at 6 months. CONCLUSION: The Serranator is a safe and efficacious angioplasty balloon catheter system. This new design provides an exciting potential for optimizing vessel preparation and aiding drug delivery.

Comparison of the efficacy of available statistical methods for prediction of the hospitalizations number: proof of concept and validation based on the analysis of Polish National Health Fund data in the years 2009-2017.

The aim of the study was to choose and validate the tool(s) to predict the number of hospitalized patients by testing three predictive algorithms: a linear regression model, Auto-Regressive Moving Average (ARMA) model, and Generalized Auto-Regressive Conditional Heteroskedasticity (GARCH) model. The study used data from the collection of data on inflammatory bowel diseases (IBD) from the public database of the National Health Fund for the years 2009-2017, data recalculation taking into account the population of provinces and the country in particular years, and prediction making for the number of patients who would require hospitalization in 2017. The anticipated numbers were compared with real data and percentage prediction errors were calculated. Results of prediction for 2017 indicated the number of hospitalizations for Crohn's disease (CD) and ulcerative colitis (UC) at 17 and 16 respectively per 100,000 persons and 72 per 100,000 persons for all IBD cases. The actual outcomes were 21 for both CD and UC (81% and 75% accuracy of prediction, respectively), and 99 for all IBD cases (73% accuracy). The prediction results do not differ significantly from the actual outcome, this means that the prediction tool (in the form of a linear regression) actually gives good results. Our study showed that the newly developed tool may be used to predict with good enough accuracy the number of patients hospitalized due to IBD in order to organize appropriate therapeutic resources.

[Amaurosis fugax in inferior wall myocardial infarction with ST segment elevation].

The patient, a fifty nine year old male, was admitted to the ward with symptoms of inferior wall myocardial infarction with ST segment elevation combined with intermittent right side sight loss. Despite typical resting stenocardial chest pain, ST segment elevation in ECG, transient symptoms of acute heart failure and slightly elevated myocardial necrosis biomarkers, coronarography did not reveal obvious source of myocardial ischemia. Moreover, echocardiography did not confirm decreased ejection fraction. However further research confirmed critical stenosis of the left internal carotid artery and chronic occlusion of the right internal carotid artery. Several questions were raised during diagnostic process including: the cause of cardiac ischemia and the cause of cerebral ischemia. Clinical data analysis and available literature allowed authors to exclude cerebral ischemia as a source of ECG ischemic changes and to establish transient myocardial ischemia causing circulatory decompensation amplified by carotid arteries atherosclerosis as the source of neurological symptoms.

Designing movement space for elderly and disabled people in the construction law in selected countries.

BACKGROUND: Building law regulations determine designing the built environment recognising the needs of users of different ages and psychophysical abilities. Seniors and their spatial needs are covered there to a limited extent. The benchmark for design are wheelchair users. Their spatial requirements are greater in relation to independent walkers, including most older people. This makes it difficult to adapt the whole built environment to the needs of people with less mobility dysfunction. This can be considered in terms of spatial design and investment costs. MATERIAL AND METHODS: The paper analyses the building regulations of 3 countries in terms of legal conditions to shape the architectural movement space of older people and disabled people. Analytical and comparative methods are used. Such research is becoming relevant and necessary. The analyses are conducted in the context of ageing populations. They are justified by statistical data on the age groups of Polish society. This is followed by design analyses of the legal requirements in the wheelchair movement space and proposals for alternatives, e.g., people walking with canes (case study). Their aim is to indicate methods to limit excessive communication spaces in buildings while maintaining functional values for all users. RESULTS: Research may show the possibility of greater diversification of regulations and alternatives to current laws. They are dedicated to participants in investment processes to shape accessible buildings. They can also be used in legislative work on amendments to the construction law. CONCLUSIONS: Changes in building regulations and a detailed approach to the mobility needs of older and disabled people (walking independently) are proposed. These decisions can provide benefits (spatial and economic savings). They fall into the "design for all" trend and sustainability of the built environment. These demands are based on no longer valid normative regulations. Med Pr Work Health Saf. 2024;75(3).

Machine Meets Brain: A Systematic Review of Effectiveness of Robotically Performed Cerebral Angiography Interventions.

BACKGROUND: Stroke is a leading cause of death in the United States, with significant economic and human costs. Early diagnosis and rapid treatment are critical for preventing stroke-related morbidity and mortality. However, accessibility to neurointerventional medical centers remains a challenge for many Americans, highlighting the need for innovative solutions to improve stroke management. METHODS: This systematic review adhered to the PRISMA (preferred reporting items for systematic reviews and meta-analyses) guidelines and included 5 medical databases to identify relevant studies on robotically assisted cerebral angiography (RCA). Studies focusing on in-human robotic intracranial cerebral angiography were included. A bias assessment was conducted using appropriate tools for randomized controlled trials (RCTs) and non-RCTs. RESULTS: A total of 7 studies met the inclusion criteria, with 1 RCT and 6 non-RCTs included in the analysis. Robotic systems such as CorPath GRX, Magellan robot, YDHB-NS01, VIR-2 (vascular interventional robot), and RobEnt were evaluated. The studies reported various success rates, procedure times, and complications associated with robotically assisted procedures. Overall, the robotic interventions demonstrated promising results in terms of safety and efficacy, with comparable outcomes to manual methods. Despite the promising findings, several limitations were identified, including technical issues with the robotic systems, the high costs, and limited long-term data. Future research should focus on standardizing protocols, conducting larger trials with longer follow-up periods, and assessing cost-effectiveness to determine the role of RCA in clinical practice. CONCLUSIONS: RCA shows potential as a valuable tool in neuroendovascular interventions. Addressing the technical challenges and conducting further research will be crucial to fully realize the clinical benefits of this innovative technology and improve patient outcomes in stroke management.

The Influence of SARS-CoV-2 Infection on Acute Myocardial Infarction Outcomes.

BACKGROUND: This multicenter retrospective study with a control group was designed to assess the influence of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection on the outcomes of patients with myocardial infarction (MI). METHODS: A total of 129 patients with COVID-19 who were treated for MI were included in this study. The control group comprised 129 comparable patients without SARS-CoV-2 infection. The in-hospital, out-of-hospital, and overall mortality were analyzed. RESULTS: A total of thirty-one (24%) patients died in the study group, and two (1.6%) patients died in the control group (OR = 20.09; CI: 4.69-85.97; p < 0.001). Similar results were observed in all analyzed patient subgroups. Multivariable Cox regression analysis confirmed the significant influence of SARS-CoV-2 infection on in-hospital outcomes (HR: 8.48459; CI: 1.982-36.320; p = 0.004). Subanalysis of the groups with COVID-19 plus ST-elevation MI (STEMI) or non-ST-elevation MI (NSTEMI) revealed comparable mortality rates: 14 (21.12%) patients in the NSTEMI group and 17 (26.98%) patients in the STEMI subgroup died (OR: 1.3; CI: 0.56-3.37; p = 0.45). During out-of-hospital observation, no differences in mortality were observed (OR: 0.77; CI: 0.11-4.07; p = 0.73). CONCLUSIONS: SARS-CoV-2 infection affects the in-hospital outcomes of patients with both MI and COVID-19, regardless of MI type (STEMI vs. NSTEMI).

Long-term results of cephalad arteries percutanoeus transluminal angioplasty with stent implantation (The CAPTAS registry).

INTRODUCTION: Carotid artery stenting (CAS) has become an alternative to carotid endarterectomy. Moreover, percutaneous transluminal angioplasty (PTA) allows other cephalad arteries revascularization. The aim of this study was to evaluate late outcomes of cephalad arteries PTA. METHODS: This is an international multicenter registry of 434 consecutive patients in which 497 PTAs were performed. Patients with symptomatic >50% stenosis or asymptomatic >70% stenosis were enrolled. Stenting of 577 internal carotid arteries (ICA) and 13 common carotid arteries was performed, 20.7% procedures were complex in which bilateral carotid stenoses or carotid and vertebral arteries stenoses were revascularized at one stage. In 15.9% patients, one-stage coronary intervention was carried out. Distal protection devices were used in 69.6% of cases. PTAs were divided into high (n = 330) and low (n = 167) risk of major adverse coronary and cerebral events (MACCE). RESULTS: At 30 days, there were 15 (3.5%) cases of MACCE [0.9% deaths, 2.1% strokes, and 0.9% myocardial infarction (MI)]. TIAs were observed in 15 (3.9%) patients. There was no significant difference in stroke incidence between procedures with or without neuroprotection (1.8 vs. 3%; P = 0.66) as well as in MACCE occurrence between high and low-risk groups (4.3 vs. 2%; P = 0.34). Bilateral stenoses increased while hypertension decreased the risk of MACCE. Left ICA lesions increased the risk of cerebrovascular accidents (CVA). At 4 years (1-11 years), the mortality rate was 11.5%, 6% of patients had stroke, and 3% MIs. Restenosis occurred in 3%. There was a trend toward higher mortality rate (13.3 vs. 6.9%; P = 0.07) and MACCE risk in high-risk group (23.5 vs.14.7% P = 0.06). Age > 65 y.o. and stent length < 24 mm increased, while the statin therapy on admission decreased the risk of long-term death. Structural valve disease and stent length <30 mm increased the risk of MACCE, while implantation of Acculink stent decreased the risk of CVA. CONCLUSIONS: 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.

Analysis of Prognostic Factors Affecting Short-term and Long-term Outcomes of Gastric Cancer Resection.

BACKGROUND: The aim of this study was the analysis of the influence of prognostic factors on short- and long-term outcomes of gastric cancer resection. PATIENTS AND METHODS: A database of 709 patients who had gastric cancer resection between 2007 and 2015 was compiled. RESULTS: Total gastrectomy (TG) and subtotal proximal gastrectomy (SPG) significantly increased the risk of overall complications (p=0.0015 and 0.0173, respectively) and surgical complications (p=0.0141 and 0.0035, respectively). Moreover the resection of an additional organ was an independent prognostic factor of overall complications (p<0.0001), systemic complications (p=0.0503), surgical complications (p<0.0001) and relaparotomy (p=0.0259). T stage (p<0.0001), N stage (p<0.0001), M stage (p<0.0001) and radical resection (p<0.0001) significantly affected 5-year survival rates. CONCLUSION: Early diagnosis and radical resection was crucial in 5-year survival rates. However, the type of gastrectomy and the resection of an additional organ were the most important factors in short-term outcomes of treatment for such patients.

Iatrogenic occlusion of bilateral jugular veins, subclavian vein, and superior vena cava after repeated jugular cannulation associated with Arnold-Chiari malformation: Successful endovascular treatment.

An Arnold-Chiari malformation is a congenital central nervous system defect. Raised intracranial pressure is commonly observed, and posterior decompression neurosurgery is the treatment of choice. We describe a patient with iatrogenic occlusion of bilateral jugular veins, subclavian vein, and superior vena cava resulting from repeated central venous cannulations. Because of venous hypertension, the patient suffered from neurologic symptoms: headaches, vision disturbances, and marked head edema. Two stents were used to recanalize the right internal jugular vein and superior vena cava. Symptoms subsided, and the patient returned to work. During 24-month follow-up, stents were patent. The patient remains symptom free and continues working.

Prospective multicentre study of carotid artery stenting using the MER™ Stent - the OCEANUS study - 30-day and one-year follow-up results.

INTRODUCTION: Constant technological progress in the field of carotid stenting translates into improved short- and long-term results of endovascular treatment. The introduction of a new generation, self-expanding, open-cell stent has provided a new treatment option in endovascular management of carotid stenosis. AIM: To evaluate 30-day and 1-year clinical outcomes of non-consecutive patients with high risk of carotid endarterectomy, who underwent 5F cylinder-tapered MER™ open-cell carotid stent implantation. MATERIAL AND METHODS: It was a single-arm, prospective study conducted in four experienced catheterisation centres. The use of embolic protection devices was mandatory. The primary endpoint was stroke in 30-day follow-up. The secondary endpoints were 30-day and 1-year cumulative incidence of death, stroke and myocardial infarction, 1-year target vessel revascularisation, procedural success (residual stenosis ≤ 30%), restenosis rate (%DS ≥ 50%), and Serious Adverse Device Effect (SADE) rate in 1-year follow-up. RESULTS: In total 100 patients were recruited for the study, with the majority being males (n = 61). The mean age was 68.3 ±8.2 years, and most of the patients were asymptomatic (n = 56). In 55 (55%) patients direct stenting was performed, with the use of proximal protection devices in 19 (19%) patients. Mean internal carotid artery/common carotid artery stenosis before and after stent implantation was 81.98 ±9.15% and 12.52 ±8.70%, respectively (p < 0.001). Procedural success was achieved in all cases. One ischaemic stroke was observed at 30 days (1%, primary endpoint). At 1-year follow-up two myocardial infarctions and three deaths occurred with no additional stroke. CONCLUSIONS: The OCEANUS study indicated the safety and efficacy of the MER™ stent during 30-day and 1-year follow-up in both symptomatic and asymptomatic patients. The majority of patients were event-free. However, larger cohort studies are needed to evaluate MER™ stents in detail.

Five-year outcomes after revascularization of superficial femoral artery occlusion using Ocelot catheter.

INTRODUCTION: The population of patients with lower limb atherosclerosis includes a considerable proportion of individuals with long superficial femoral artery (SFA) lesions. Chronic total occlusions (CTOs) represent the "last frontier" of percutaneous interventions. While open strategies are considered earlier as standard management for these lesions, the results of a number of trials indicate that endovascular management might become an effective alternative to surgery. MATERIAL AND METHODS: This paper presents 5-year outcomes of a first-in-man (FIM) study (before CE mark) and the registry of OCT Guided Ocelot Catheter (Avinger) for chronic total occlusions of the superficial femoral artery. The study group comprised 10 patients with Rutherford 3 lower limb ischemia including nine men and one woman. RESULTS: The efficacy of the primary intervention was 90%. Angiography performed at 6 months of the procedure, according to the study protocol, revealed 3 and 1 cases of restenosis and reocclusion, respectively, repaired using PTA and open common and deep femoral artery patch plasty. Doppler ultrasound performed at 1, 2 and 5 years after the primary intervention did not reveal significant target vessel restenosis. The primary and primary-assisted patency was 89%. During a 5-year follow-up, four peripheral percutaneous interventions and one femoropopliteal bypass surgery were performed in non-target limbs. There were no cardiovascular deaths, myocardial infarction or stroke and no amputation was required. CONCLUSIONS: This is a first-in-man study reporting long-term follow-up after SFA CTO revascularization using the Ocelot catheter. The catheter proved to have a satisfactory safety profile and a high proportion of CTO crossings. A 5-year follow-up revealed high primary and primary-assisted patency rates.

Safety and biocompatibility of a novel self-expanding nitinol carotid stent with hybrid cell design in a porcine model of neointimal hyperplasia.

BACKGROUND: Stent design may influence the outcomes, suggesting that adverse event rates vary according to free cell area and cell design. Open cell design technology of self-expandable stents, dedicated for carotid revascularisation has better deliverability, although closed cell technology is expected to cause fewer thromboembolic events. AIM: To evaluate the feasibility and vascular response of novel, hybrid cell, self-expandable nitinol stents (MER®, Balton, Poland) implanted into porcine carotid arteries. Hybrid cell design combines open and closed cell technology. METHODS: All tested stents were implanted with 10% overstretch into 10 carotid segments of Polish domestic pigs. Control angiography was obtained immediately before and after vascular interventions as well as 28 days after the procedure. Thereafter, animals were sacrificed, and the treated segments were harvested and evaluated in the independent histopathology laboratory. RESULTS: All stents were easily introduced and implanted, showing good angiographic acute outcome. At 28 days, in the angiography, all vessels were patent with no signs of thrombi or excessive neointimal formation, with the late lumen loss of -0.11 ± 0.3 mm and percentage diameter stenosis 10.18 ± 8.1%. There was a 10% increase in the vessel reference diameter when compared to baseline (4.57 ± 0.5 vs. 4.96 ± 0.3 mm, p < 0.01). In the histopathology, mean area stenosis was 17.4% and mean intimal thickness was 0.20 mm. At histopathology, the mean injury, inflammation, and fibrin scores were low. Endothelialisation was complete in all stents, and neointimal tissue appeared moderately mature as shown by the moderate mean neointimal smooth muscle score. Nonetheless, histopathology shows one stent affected by peri-strut granulomas and one stent affected by marked mineralisation. CONCLUSIONS: The novel Polish self-expandable nitinol carotid stent with hybrid cell technology shows optimal biocompatibility and a vascular healing profile, and therefore may be introduced for first-in-man application.