Acute Outcomes for the Full US Cohort of the FLASH Mechanical Thrombectomy Registry in Pulmonary Embolism

Background Evidence supporting interventional pulmonary embolism (PE) treatment is needed. Aims We aimed to evaluate the acute safety and effectiveness of mechanical thrombectomy for intermediate- and high-risk PE in a large real-world population. Methods FLASH is a multicentre, prospective registry enrolling up to 1,000 US and European PE patients treated with mechanical thrombectomy using the FlowTriever System. The primary safety endpoint is a major adverse event composite including device-related death and major bleeding at 48 hours, and intraprocedural adverse events. Acute mortality and 48-hour outcomes are reported. Multivariate regression analysed characteristics associated with pulmonary artery pressure and dyspnoea improvement. Results Among 800 patients in the full US cohort, 76.7% had intermediate-high risk PE, 7.9% had high-risk PE, and 32.1% had thrombolytic contraindications. Major adverse events occurred in 1.8% of patients. All-cause mortality was 0.3% at 48-hour follow-up and 0.8% at 30-day follow-up, with no device-related deaths. Immediate haemodynamic improvements included a 7.6 mmHg mean drop in mean pulmonary artery pressure (-23.0%; p Conclusions Mechanical thrombectomy with the FlowTriever System demonstrates a favourable safety profile, improvements in haemodynamics and functional outcomes, and low 30-day mortality for intermediate- and high-risk PE

Randomized Controlled Trial of Mechanical Thrombectomy Versus Catheter-directed Thrombolysis for Acute Hemodynamically Stable Pulmonary Embolism: Rationale and Design of the PEERLESS Study.

BACKGROUND The identification of hemodynamically stable pulmonary embolism (PE) patients who may benefit from advanced treatment beyond anticoagulation is unclear. However, when intervention is deemed necessary by the PE patient's care team, data to select the most advantageous interventional treatment option are lacking. Limiting factors include major bleeding risks with systemic and locally delivered thrombolytics and the overall lack of randomized controlled trial (RCT) data for interventional treatment strategies. Considering the expansion of the Pulmonary Embolism Response Team (PERT) model, corresponding rise in interventional treatment, and number of thrombolytic and non-thrombolytic catheter-directed devices coming to market, robust evidence is needed to identify the safest and most effective interventional option for patients. METHODS The PEERLESS study (ClinicalTrials.gov identifier: NCT05111613) is a currently enrolling multinational RCT comparing large-bore mechanical thrombectomy (MT) with the FlowTriever System (Inari Medical, Irvine, CA) vs catheter-directed thrombolysis (CDT). A total of 550 hemodynamically stable PE patients with right ventricular (RV) dysfunction and additional clinical risk factors will undergo 1:1 randomization. Up to 150 additional patients with absolute thrombolytic contraindications may be enrolled into a non-randomized MT cohort for separate analysis. The primary endpoint will be assessed at hospital discharge or 7 days post procedure, whichever is sooner, and is a composite of the following clinical outcomes constructed as a hierarchal win ratio: 1) all-cause mortality, 2) intracranial hemorrhage, 3) major bleeding, 4) clinical deterioration and/or escalation to bailout, and 5) intensive care unit admission and length of stay. The first 4 components of the win ratio will be adjudicated by a Clinical Events Committee, and all components will be assessed individually as secondary endpoints. Other key secondary endpoints include all-cause mortality and readmission within 30 days of procedure and device- and drug-related serious adverse events through the 30-day visit. IMPLICATIONS PEERLESS is the first RCT to compare two different interventional treatment strategies for hemodynamically stable PE and results will inform strategy selection after the physician or PERT determines advanced therapy is warranted

TCT-170 Development and Validation of a Scoring System for Predicting Clinical Coronary Artery Perforation During Percutaneous Coronary Interventions of Chronic Total Occlusions: The PROGRESS-CTO Perforation Score

Background: Coronary artery perforation is a feared complication of chronic total occlusion (CTO) percutaneous coronary intervention (PCI) and often leads to serious adverse clinical events. Methods: We analyzed clinical and angiographic parameters from 9,618 CTO PCIs in the PROGRESS-CTO (Prospective Global Registry for the Study of Chronic Total Occlusion Intervention). Logistic regression prediction modeling was used to identify independently associated variables, and models were internally validated with bootstrapping. Clinical coronary artery perforation was defined as any perforation requiring treatment. Results: The incidence of clinical coronary perforation was 3.8% (n = 367). Five factors were independently associated with perforation and were included in the score: patient age ≥ 65 years, +1 point (OR: 1.79; 95% CI: 1.37-2.33); moderate or severe calcification, +1 point (OR: 1.85; 95% CI: 1.41-2.42); blunt or no stump, +1 point (OR: 1.45; 95% CI: 1.10-1.92); use of antegrade dissection and re-entry strategy, +1 point (OR: 2.43; 95% CI: 1.61-3.69); and use of the retrograde approach, +2 points (OR: 4.02; 95% CI: 2.95-5.46). The resulting score showed acceptable performance on receiver-operating characteristic curve (area under the curve: 0.741; 95% CI: 0.712-0.773). The Hosmer-Lemeshow test indicated good fitness (P = 0.991), and internal validation with bootstrapping demonstrated a good agreement with the model (observed area under the curve: 0.736; 95% bias-corrected CI: 0.706-0.767). Conclusions: The PROGRESS-CTO perforation score is a useful tool for prediction of clinical coronary perforation in CTO PCI. Categories: CORONARY: Complex and Higher Risk Procedures for Indicated Patients (CHIP

TCT-117 Impact of Proximal Cap Ambiguity on the Outcomes of Chronic Total Occlusion Intervention: Insights From the PROGRESS-CTO Registry

Background: The impact of proximal cap ambiguity on procedural techniques and outcomes of chronic total occlusion (CTO) percutaneous coronary intervention (PCI) has received limited study. Methods: We examined the clinical and angiographic characteristics and procedural outcomes of 11,169 CTO PCIs performed in 10,932 patients at 42 US and non-US centers between 2012 and 2022. Results: Proximal cap ambiguity was present in 35% of CTO lesions. Patients whose lesions had proximal cap ambiguity were more likely to have had prior PCI (65% vs 59%; P \u3c 0.01) and prior coronary artery bypass graft surgery (37% vs 24%; P \u3c 0.01). Lesions with proximal cap ambiguity were more complex with higher J-CTO score (3.1 ± 1.0 vs 2.0 ± 1.2; P \u3c 0.01) and lower technical (79% vs 90%; P \u3c 0.01) and procedural success (77% vs 89%; P \u3c 0.01) rates compared with non-ambiguous CTO lesions. The incidence of major adverse cardiovascular events (MACE) was higher in cases with proximal cap ambiguity (2.5% vs 1.7%; P \u3c 0.01). The retrograde approach was more commonly used among cases with ambiguous proximal cap (51% vs 21%; P \u3c 0.01) and was more likely to be the final successful crossing strategy (29% vs 13%; P \u3c 0.01). PCIs of CTOs with ambiguous proximal cap required longer procedure time (140 [95-195] vs 105 [70-150] min; P \u3c 0.01) and more contrast volume (225 [160-305] vs 200 [150-280] mL; P \u3c 0.01). Conclusion: Proximal cap ambiguity in CTO lesions is associated with higher utilization of the retrograde approach, lower technical and procedural success rates, and higher incidence of in-hospital MACE. Categories: CORONARY: Complex and Higher Risk Procedures for Indicated Patients (CHIP

Randomized Controlled Trial of Mechanical Thrombectomy vs Catheter-Directed Thrombolysis for Acute Hemodynamically Stable Pulmonary Embolism: Rationale and Design of the PEERLESS Study

BACKGROUND: The identification of hemodynamically stable pulmonary embolism (PE) patients who may benefit from advanced treatment beyond anticoagulation is unclear. However, when intervention is deemed necessary by the PE patient\u27s care team, data to select the most advantageous interventional treatment option are lacking. Limiting factors include major bleeding risks with systemic and locally delivered thrombolytics and the overall lack of randomized controlled trial (RCT) data for interventional treatment strategies. Considering the expansion of the pulmonary embolism response team (PERT) model, corresponding rise in interventional treatment, and number of thrombolytic and nonthrombolytic catheter-directed devices coming to market, robust evidence is needed to identify the safest and most effective interventional option for patients. METHODS: The PEERLESS study (ClinicalTrials.gov identifier: NCT05111613) is a currently enrolling multinational RCT comparing large-bore mechanical thrombectomy (MT) with the FlowTriever System (Inari Medical, Irvine, CA) vs catheter-directed thrombolysis (CDT). A total of 550 hemodynamically stable PE patients with right ventricular (RV) dysfunction and additional clinical risk factors will undergo 1:1 randomization. Up to 150 additional patients with absolute thrombolytic contraindications may be enrolled into a nonrandomized MT cohort for separate analysis. The primary end point will be assessed at hospital discharge or 7 days post procedure, whichever is sooner, and is a composite of the following clinical outcomes constructed as a hierarchal win ratio: (1) all-cause mortality, (2) intracranial hemorrhage, (3) major bleeding, (4) clinical deterioration and/or escalation to bailout, and (5) intensive care unit admission and length of stay. The first 4 components of the win ratio will be adjudicated by a Clinical Events Committee, and all components will be assessed individually as secondary end points. Other key secondary end points include all-cause mortality and readmission within 30 days of procedure and device- and drug-related serious adverse events through the 30-day visit. IMPLICATIONS: PEERLESS is the first RCT to compare 2 different interventional treatment strategies for hemodynamically stable PE and results will inform strategy selection after the physician or PERT determines advanced therapy is warranted

Failure Recovery with Ontologically Generated Behaviour Trees

Behaviour trees (BTs) serve as a powerful hierarchical structure for task execution, simplifying complex tasks but posing challenges in their manual design. The automatic generation of BTs addresses this concern, yet often lacks robust failure recovery options. This study presents Failure Recovery with Ontologically Generated Behaviour Trees (FROGBT), a novel approach bridging this gap by integrating ontological reasoning into the process of automatically generating BTs. This integration establishes a profound link between an agent’s knowledge and its capabilities, offering contextual insights into the agent’s skills. FROGBT enhances skill representation for planning and recovery. The approach’s effectiveness is indicated by its efficiency compared to the state-of-the-art framework for skill-based control, SkiROS, in a similar task. It showcases generality, uniting diverse skills, developed by various engineers, for recurring tasks, and introduces innovative failure recovery strategies. FROGBT highlights ontological reasoning’s potential to enhance BT generation with context-awareness and reasoning abilities, paving the way for future research on failure recovery concepts in generated BTs.Mechanical Engineering | Vehicle Engineering | Cognitive Robotic

Outcome and quality of care of patients who have acute myocardial infarction

Coronary artery disease is the number-one killer in developed countries, with lifetime prevalence of up to 50% in American men, and is the topic of much medical literature. Recently, multiple therapies have emerged to save lives after acute myocardial infarction (AMI), backed by well-conducted studies; however, appropriate implementation of therapy guidelines is less than optimal. Recent efforts have focused on improving the quality of care (QC) after AMI in order to improve outcomes. This article illustrates how outcome after AMI is related to QC, describes the underuse of evidence-based therapies, and discusses factors associated with poor guideline adherence. It also reviews current quality improvement projects, and some available means to measure and optimize the QC for patients with AMI

Outcome and quality of care of patients who have acute myocardial infarction

Coronary artery disease is the number-one killer in developed countries, with lifetime prevalence of up to 50% in American men, and is the topic of much medical literature. Recently, multiple therapies have emerged to save lives after acute myocardial infarction (AMI), backed by well-conducted studies; however, appropriate implementation of therapy guidelines is less than optimal. Recent efforts have focused on improving the quality of care (QC) after AMI in order to improve outcomes. This article illustrates how outcome after AMI is related to QC, describes the underuse of evidence-based therapies, and discusses factors associated with poor guideline adherence. It also reviews current quality improvement projects, and some available means to measure and optimize the QC for patients with AMI

Impact of a program of aerobic exercises on physiological variables and the shape and size of the fetus in pregnant female basketball players

The aim of this study was to identify the impactof a programaerobic exercises on the shape and size of the fetus, andthe percentage of the contribution of some of the studied physiological variables and their impact on the shape and size of the fetus among female basketball players. The researchersused the experimental method.The study population represented 10 pregnant married basketball players from the Al-Diwaniyah, Babil and Wasit Governorates. Their ages ranged from 25 to 26 years. The sample was randomly divided into two groups (experimental group = 5 members, control group = 5 members). The members of the experimental group receivedthe training units of the program proposed by the researchers, while the members of the control group received the traditional training units. The Statistical Packagefor the Social Sciences (SPSS) was used for data analysis. The results of the study showed statistically significant differences between the two tests (the pre-and post-test) for the proposed aerobic exercises, in favor of the post-test for the experimental group (p 0.05)of some studied physiological variables for the control group, but there were statistically significant differences between the responses of the research sample on a three-way estimate scale (less than normal, normal, above normal) (p < 0.05). There is a clear effect of the proposed aerobic exercises on the growth, shape, and size of the fetus in female basketball players