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

Impact of Active and Historical Cancers on the Management and Outcomes of Acute Myocardial Infarction Complicating Cardiogenic Shock

BACKGROUND: There are limited data on the outcomes of acute myocardial infarction-cardiogenic shock (AMI-CS) in patients with concomitant cancer. METHODS: A retrospective cohort of adult AMI-CS admissions was identified from the National Inpatient Sample (2000-2017) and stratified by active cancer, historical cancer, and no cancer. Outcomes of interest included in-hospital mortality, use of coronary angiography, use of percutaneous coronary intervention, do-not-resuscitate status, palliative care use, hospitalization costs, and hospital length of stay. RESULTS: Of the 557,974 AMI-CS admissions during this 18-year period, active and historical cancers were noted in 14,826 (2.6%) and 27,073 (4.8%), respectively. From 2000 to 2017, there was a decline in active cancers (adjusted odds ratio, 0.70 [95% CI, 0.63-0.79]; P \u3c .001) and an increase in historical cancer (adjusted odds ratio, 2.06 [95% CI, 1.89-2.25]; P \u3c .001). Compared with patients with no cancer, patients with active and historical cancer received less-frequent coronary angiography (57%, 67%, and 70%, respectively) and percutaneous coronary intervention (40%, 47%, and 49%%, respectively) and had higher do-not-resuscitate status (13%, 15%, 7%%, respectively) and palliative care use (12%, 10%, 6%%, respectively) (P \u3c .001). Compared with those without cancer, higher in-hospital mortality was found in admissions with active cancer (45.9% vs 37.0%; adjusted odds ratio, 1.29 [95% CI, 1.24-1.34]; P \u3c .001) but not historical cancer (40.1% vs 37.0%; adjusted odds ratio, 1.01 [95% CI, 0.98-1.04]; P = .39). AMI-CS admissions with cancer had a shorter hospitalization duration and lower costs (all P \u3c .001). CONCLUSION: Concomitant cancer was associated with less use of guideline-directed procedures. Active, but not historical, cancer was associated with higher mortality in patients with AMI-CS

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

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

A cross‐sectional study of outcomes for patients undergoing mechanical thrombectomy for pulmonary embolism during 2018–2022: Insights from the PINC AI Healthcare Database

Abstract Background and Aims Mechanical thrombectomy (MT) treatments for pulmonary embolism (PE) have yet to be compared directly. We aimed to determine if patient outcomes varied following treatment of PE with different MT devices. Methods All PE encounters with an index treatment of MT between January 2018 and March 2022 were analyzed for in‐hospital mortality, discharge to home, and 30‐day readmission outcomes in the PINC AI™ Healthcare Database. MT devices used in each encounter were extracted from hospital charge description free‐text fields using keyword text and fuzzy matching. Unadjusted and adjusted logistic regression was used to model outcomes by device. Results A total of 5893 encounters were identified using MT as the sole index PE treatment and 1812 using MT with another treatment. Of these, 41% had insufficient information to identify the devices used (unspecified MT), 33% used the FlowTriever System (large‐bore volume‐controlled aspiration MT), 23% the Indigo System (continuous aspiration MT), and 3% some other MT. Large‐bore volume‐controlled aspiration MT was used with other treatments 13% of the time compared with 23% and 39% for unspecified MT and continuous aspiration MT, respectively. Adjusted logistic regression modeling revealed the odds of in‐hospital mortality were significantly higher for patients treated with unspecified MT ([OR] = 1.42, 95% confidence interval [CI]: [1.10–1.83], p = 0.008) or continuous aspiration MT (OR = 1.63, 95% CI: [1.21–2.19], p = 0.001) compared with large‐bore volume‐controlled aspiration MT. Discharge to home was significantly lower in these same groups (OR = 0.84, 95% CI: [0.73–0.96], p = 0.01, and OR = 0.63, 95% CI: [0.53–0.74], p < 0.001, respectively), but readmission risks at 30 days were comparable (OR = 1.08, 95% CI: [0.84–1.38], p = 0.56, and OR = 1.20, 95% CI: [0.89–1.62], p = 0.24, respectively). Conclusion PE outcomes and treatment patterns differ significantly based on the type of MT utilized. Clinical studies directly comparing MT treatments are needed to further understand optimal treatment of PE