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1.
J Am Coll Cardiol ; 84(15): 1436-1454, 2024 Oct 08.
Article in English | MEDLINE | ID: mdl-39357941

ABSTRACT

This consensus statement emerges from collaborative efforts among leading figures in critical care cardiology throughout the United States, who met to share their collective expertise on issues faced by those active in or pursuing contemporary critical care cardiology education. The panel applied fundamentals of adult education and curriculum design, reviewed requisite training necessary to provide high-quality care to critically ill patients with cardiac pathology, and devoted attention to a purposeful approach emphasizing diversity, equity, and inclusion in developing this nascent field. The resulting paper offers a comprehensive guide for current trainees, with insights about the present landscape of critical care cardiology while highlighting issues that need to be addressed for continued advancement. By delineating future directions with careful consideration and intentionality, this Expert Panel aims to facilitate the continued growth and maturation of critical care cardiology education and practice.


Subject(s)
Cardiology , Critical Care , Cardiology/education , Humans , Critical Care/standards , United States , Curriculum , Minnesota , Education, Medical, Graduate/methods
2.
Thromb Res ; 244: 109177, 2024 Oct 05.
Article in English | MEDLINE | ID: mdl-39369656

ABSTRACT

BACKGROUND AND AIMS: Patients with intermediate-risk pulmonary embolism (PE) commonly present with a significantly reduced cardiac index (CI). However, the identification of this more severe profile requires invasive hemodynamic monitoring. Whether inferior vena cava (IVC) contrast reflux, as a marker of worse right ventricular function, can predict invasive hemodynamics has not been explored. METHODS: This was a single-center retrospective study over a 3-year period of consecutive patients with PE undergoing mechanical thrombectomy and simultaneous pulmonary artery catheterization. CT pulmonary angiograms were reviewed, and contrast reflux was graded as no/minimal reflux (limited to the IVC) or substantial (opacification including hepatic veins) based on an established scale. RESULTS: Substantial contrast reflux was present in 29 of 85 patients (34 %) and associated with a lower CI (1.8 ± 0.4 L/min/m2 v. 2.6 ± 1.0 L/min/m2, p < 0.001), higher pulmonary artery systolic pressure (53.2 ± 19.5 mmHg v. 44.0 ± 12.1 mmHg, p = 0.025), and worse right ventricular systolic function. An IVC contrast reflux grade > 3 was a significant predictor for a CI ≤2.2 L/min/m2 (OR: 22.5, 95 % CI: 4.8, 104.4, p < 0.001). Sensitivity, specificity, positive predictive value, and negative predictive value for substantial contrast reflux for a CI ≤2.2 L/min/m2 were 62.6 %, 93.1 %, 94.6 %, and 56.2 %, respectively. These findings remained significant in a multivariable model and were similar when isolating for intermediate-risk patients (n = 72, 85 %). CONCLUSIONS: The degree of contrast reflux is highly specific for a reduced cardiac index in PE even when isolating for intermediate-risk patients. Real-time prediction of a hemodynamic profile may have added value in the risk-stratification of PE.

3.
Circulation ; 150(14): 1140-1150, 2024 Oct.
Article in English | MEDLINE | ID: mdl-39263752

ABSTRACT

Recent advances in therapy and the promulgation of multidisciplinary pulmonary embolism teams show great promise to improve management and outcomes of acute pulmonary embolism (PE). However, the absence of randomized evidence and lack of consensus leads to tremendous variations in treatment and compromises the wide implementation of new innovations. Moreover, the changing landscape of health care, where quality, cost, and accountability are increasingly relevant, dictates that a broad spectrum of outcomes of care must be routinely monitored to fully capture the impact of modern PE treatment. We set out to standardize data collection in patients with PE undergoing evaluation and treatment, and thus establish the foundation for an expanding evidence base that will address gaps in evidence and inform future care for acute PE. To do so, >100 international PE thought leaders convened in Washington, DC, in April 2022 to form the Pulmonary Embolism Research Collaborative. Participants included physician experts, key members of the US Food and Drug Administration, patient representatives, and industry leaders. Recognizing the multidisciplinary nature of PE care, the Pulmonary Embolism Research Collaborative was created with representative experts from stakeholder medical subspecialties, including cardiology, pulmonology, vascular medicine, critical care, hematology, cardiac surgery, emergency medicine, hospital medicine, and pharmacology. A list of critical evidence gaps was composed with a matching comprehensive set of standardized data elements; these data points will provide a foundation for productive research, knowledge enhancement, and advancement of clinical care within the field of acute PE, and contribute to answering urgent unmet needs in PE management. Evidence produced through the Pulmonary Embolism Research Collaborative, as it is applied to data collection, promises to provide crucial knowledge that will ultimately produce a robust evidence base that will lead to standardization and harmonization of PE management and improved outcomes.


Subject(s)
Consensus , Pulmonary Embolism , Pulmonary Embolism/therapy , Pulmonary Embolism/diagnosis , Humans , Acute Disease
4.
J Soc Cardiovasc Angiogr Interv ; 3(1): 101124, 2024 Jan.
Article in English | MEDLINE | ID: mdl-39131977

ABSTRACT

Background: Acute mortality for high-risk, or massive, pulmonary embolism (PE) is almost 30% even when treated using advanced therapies. This analysis assessed the safety and effectiveness of mechanical thrombectomy (MT) for high-risk PE. Methods: The prospective, multicenter FlowTriever All-comer Registry for Patient Safety and Hemodynamics (FLASH) study is designed to evaluate real-world PE patient outcomes after MT with the FlowTriever System (Inari Medical). In this study, acute outcomes through 30 days were evaluated for the subset of patients with high-risk PE as determined by the sites and following European Society of Cardiology guidelines. An independent medical monitor adjudicated adverse events (AEs), including major AEs: device-related mortality, major bleeding, or intraprocedural device-related or procedure-related AEs. Results: Of the 799 patients in the US cohort, 63 (7.9%) were diagnosed with high-risk PE; 30 (47.6%) patients showed a systolic blood pressure <90 mm Hg, 29 (46.0%) required vasopressors, and 4 (6.3%) experienced cardiac arrest. The mean age of patients with high-risk PE was 59.4 ± 15.6 years, and 34 (54.0%) were women. At baseline, 45 (72.6%) patients were tachycardic, 18 (54.5%) showed elevated lactate levels of ≥2.5 mM, and 21 (42.9%) demonstrated depressed cardiac index of <2 L/min/m2. Immediately after MT, heart rate improved to 93.5 ± 17.9 bpm. Twenty-five (42.4%) patients did not require an overnight stay in the intensive care unit, and no mortalities or major AEs occurred through 48 hours. Moreover, no mortalities occurred in 61 (96.8%) patients followed up through the 30-day visit. Conclusions: In this cohort of 63 patients with high-risk PE, MT was safe and effective, with no acute mortalities reported. Further prospective data are needed in this population.

5.
J Crit Care ; 84: 154891, 2024 Dec.
Article in English | MEDLINE | ID: mdl-39079203

ABSTRACT

Emergent reperfusion, most commonly with the administration of thrombolytic agents, is the recommended management approach for patients presenting with high-risk, or hemodynamically unstable pulmonary embolism. However, a subset of patients with a more catastrophic presentation, including refractory shock and impending or active cardiopulmonary arrest, may require immediate circulatory support. Venoarterial extracorporeal membrane oxygenation (VA-ECMO) can be deployed rapidly by the well-trained team and provide systemic perfusion allowing for hemodynamic stabilization. Subsequent embolectomy or a standalone strategy allowing for thrombus autolysis may be followed with decannulation after several days. Retrospective studies and registry data suggest favorable clinical outcomes with the use of VA-ECMO as an upfront stabilization strategy even among patients presenting with cardiopulmonary arrest. In this review, we discuss the physiologic rationale, evidence base, and an approach to ECMO deployment and subsequent management strategies among select patients with high-risk pulmonary embolism.


Subject(s)
Extracorporeal Membrane Oxygenation , Pulmonary Embolism , Extracorporeal Membrane Oxygenation/methods , Pulmonary Embolism/therapy , Humans , Heart Arrest/therapy , Embolectomy , Thrombolytic Therapy/methods
6.
Circ Cardiovasc Interv ; 17(8): e014088, 2024 Aug.
Article in English | MEDLINE | ID: mdl-38994599

ABSTRACT

BACKGROUND: In hemodynamically stable patients with acute pulmonary embolism (PE), the Composite Pulmonary Embolism Shock (CPES) score predicts normotensive shock. However, it is unknown if CPES predicts adverse clinical outcomes. The objective of this study was to determine whether the CPES score predicts in-hospital mortality, resuscitated cardiac arrest, or hemodynamic deterioration. METHODS: Patients with acute intermediate-risk PE admitted from October 2016 to July 2019 were included. CPES was calculated for each patient. The primary outcome was a composite of in-hospital mortality, resuscitated cardiac arrest, or hemodynamic decompensation. Secondary outcomes included individual components of the primary outcome. The association of CPES with primary and secondary outcomes was evaluated. RESULTS: Among the 207 patients with intermediate-risk PE (64.7% with intermediate-high risk PE), 29 (14%) patients had a primary outcome event. In a multivariable model, a higher CPES score was associated with a worse primary composite outcome (adjusted hazard ratio [aHR], 1.81 [95% CI, 1.29-2.54]; P=0.001). Moreover, a higher CPES score predicted death (aHR, 1.76 [95% CI, 1.04-2.96]; P=0.033), resuscitated cardiac arrest (aHR, 1.99 [95% CI, 1.17-3.38]; P=0.011), and hemodynamic decompensation (aHR, 1.96 [95% CI, 1.34-2.89]; P=0.001). A high CPES score (≥3) was associated with the worse primary outcome when compared with patients with a low CPES score (22% versus 2.4%; P=0.003; aHR, 6.48 [95% CI, 1.49-28.04]; P=0.012). CPES score provided incremental prognostic value for the prediction of primary outcome over baseline demographics and European Society of Cardiology intermediate-risk subcategories (global Χ2 value increased from 0.63 to 1.39 to 13.69; P=0.005). CONCLUSIONS: In patients with acute intermediate-risk PE, the CPES score effectively risk stratifies and prognosticates patients for the prediction of clinical events and provides incremental value over baseline demographics and European Society of Cardiology intermediate-risk subcategories.


Subject(s)
Heart Arrest , Hemodynamics , Hospital Mortality , Predictive Value of Tests , Pulmonary Embolism , Shock , Humans , Pulmonary Embolism/mortality , Pulmonary Embolism/diagnosis , Pulmonary Embolism/physiopathology , Male , Female , Aged , Risk Assessment , Middle Aged , Risk Factors , Heart Arrest/mortality , Heart Arrest/diagnosis , Heart Arrest/physiopathology , Heart Arrest/therapy , Prognosis , Retrospective Studies , Shock/mortality , Shock/diagnosis , Shock/physiopathology , Time Factors , Aged, 80 and over , Decision Support Techniques
7.
Circ Cardiovasc Interv ; 17(8): e014109, 2024 Aug.
Article in English | MEDLINE | ID: mdl-38841833

ABSTRACT

BACKGROUND: Clot-in-transit is associated with high mortality, but optimal management strategies remain uncertain. The aim of this study was to compare the outcomes of different treatment strategies in patients with clot-in-transit. METHODS: This is a retrospective study of patients with documented clot-in-transit in the right heart on echocardiography across 2 institutions between January 2020 and October 2023. The primary outcome was a composite of in-hospital mortality, resuscitated cardiac arrest, or hemodynamic decompensation. RESULTS: Among 35 patients included in the study, 10 patients (28.6%) received anticoagulation alone and 2 patients (5.7%) received systemic thrombolysis, while 23 patients (65.7%) underwent catheter-based therapy (CBT; 22 mechanical thrombectomy and 1 catheter-directed thrombolysis). Over a median follow-up of 30 days, 9 patients (25.7%) experienced the primary composite outcome. Compared with anticoagulation alone, patients who received CBT or systemic thrombolysis had significantly lower rates of the primary composite outcome (12% versus 60%; log-rank P<0.001; hazard ratio, 0.13 [95% CI, 0.03-0.54]; P=0.005) including a lower rate of death (8% versus 50%; hazard ratio, 0.10 [95% CI, 0.02-0.55]; P=0.008), resuscitated cardiac arrest (4% versus 30%; hazard ratio, 0.12 [95% CI, 0.01-1.15]; P=0.067), or hemodynamic deterioration (4% versus 30%; hazard ratio, 0.12 [95% CI, 0.01-1.15]; P=0.067). CONCLUSIONS: In this study of CBT in patients with clot-in-transit, CBT or systemic thrombolysis was associated with a significantly lower rate of adverse clinical outcomes, including a lower rate of death compared with anticoagulation alone driven by the CBT group. CBT has the potential to improve outcomes. Further large-scale studies are needed to test these associations.


Subject(s)
Anticoagulants , Fibrinolytic Agents , Hospital Mortality , Thrombectomy , Thrombolytic Therapy , Humans , Male , Female , Retrospective Studies , Aged , Thrombolytic Therapy/adverse effects , Thrombolytic Therapy/mortality , Treatment Outcome , Middle Aged , Anticoagulants/adverse effects , Anticoagulants/therapeutic use , Anticoagulants/administration & dosage , Thrombectomy/adverse effects , Thrombectomy/mortality , Time Factors , Fibrinolytic Agents/administration & dosage , Fibrinolytic Agents/adverse effects , Risk Factors , Aged, 80 and over , Thrombosis/mortality , Thrombosis/diagnostic imaging , Thrombosis/etiology , Heart Arrest/therapy , Heart Arrest/mortality , Heart Arrest/physiopathology , Heart Arrest/diagnosis , Risk Assessment , Hemodynamics
8.
J Cardiol ; 2024 Jun 19.
Article in English | MEDLINE | ID: mdl-38906415

ABSTRACT

BACKGROUND: Patients with intermediate-risk pulmonary embolism (PE) and normotensive shock may have worse outcomes. However, diagnosis of normotensive shock requires invasive hemodynamics. Our objective was to assess the predictive value of McConnell's sign in identifying normotensive shock in patients with intermediate-risk PE. METHODS: Patients with intermediate-risk PE who underwent percutaneous mechanical thrombectomy between August 2020 and April 2023 at a large academic public hospital were included in the study. Normotensive shock was defined as systolic blood pressure ≥ 90 mmHg without vasopressor support with pre-procedural invasive measures of cardiac index ≤2.2 L/min/m2 and clinical evidence of hypoperfusion (i.e. elevated lactate, oliguria). The primary outcome was the association between McConnell's sign and normotensive shock. RESULTS: Those with McConnell's sign (29/40, 72.5 %) had higher heart rate (114 vs 99 beats/min, p = 0.008), higher rates of elevated lactate (86 % vs 55 %, p = 0.038), lower cardiac index (1.9 vs 3.1 L/min/m2, p = 0.003), and higher rates of normotensive shock (76 % vs 27 %, p = 0.005). McConnell's sign had a sensitivity of 88 % and specificity of 53 % for identifying intermediate-risk PE patients with normotensive shock. Patients with McConnell's sign had an increased odds (odds ratio 8.38, confidence interval: 1.73-40.53, p = 0.008; area under the curve 0.70, 95 % confidence interval: 0.56-0.85) of normotensive shock. CONCLUSION: This is the first study to suggest that McConnell's sign may identify those in the intermediate-risk group who are at risk for normotensive shock. Larger cohorts are needed to validate our findings.

9.
J Invasive Cardiol ; 2024 06 17.
Article in English | MEDLINE | ID: mdl-38935443

ABSTRACT

Objectives: The aim of this study was to compare the hemodynamic impact and clinical outcomes of saddle vs non-saddle pulmonary embolism (PE). Methods: This was a retrospective analysis of clinical characteristics and outcomes among patients with saddle and non-saddle PE within a cohort referred for catheter-based thrombectomy (CBT) with invasive hemodynamic assessments. Patients who underwent CBT between August 2020 and January 2024 were included. The primary outcome was the proportion of patients with a low cardiac index (CI < 2.2 L/min/m²). Secondary outcomes included 30-day mortality, intensive care unit (ICU) length of stay (LOS), and hospital LOS. Results: A total of 107 patients (84 intermediate risk, 23 high-risk; mean age 58 years, 47.6% female) were included in the study, with 44 patients having saddle PE and 63 having non-saddle PE. There were no significant differences in baseline demographics and clinical characteristics between saddle and non-saddle PE, including rates of high-risk PE (25% vs 16%, P = .24), rates of RV dysfunction, pulmonary artery systolic pressure (55 vs 53 mm Hg, P = .74), mean pulmonary artery pressure (34 mm Hg vs 33 mm Hg), low cardiac index (56% vs 51%, P = .64), rates of normotensive shock (27% vs 20%, P = .44), or Composite Pulmonary Embolism Shock scores (4.5 vs 4.7, P = .25). Additionally, 30-day mortality (6% vs 5%, P = .69), ICU LOS, and hospital LOS were similar between the groups. Conclusions: Among patients undergoing CBT, there were no significant differences in invasive hemodynamic parameters or clinical outcomes between those with saddle and non-saddle PE.

13.
Eur Heart J Acute Cardiovasc Care ; 13(6): 493-500, 2024 Jun 30.
Article in English | MEDLINE | ID: mdl-38454794

ABSTRACT

AIMS: Among patients with acute pulmonary embolism (PE) undergoing mechanical thrombectomy, the cardiac index (CI) is frequently reduced even among those without a clinically apparent shock. The purpose of this study is to describe the mixed venous-to-arterial carbon dioxide gradient (CO2 gap), a surrogate of perfusion adequacy, among patients with acute PE undergoing mechanical thrombectomy. METHODS AND RESULTS: This was a single-centre retrospective study of consecutive patients with PE undergoing mechanical thrombectomy and simultaneous pulmonary artery catheterization over a 3-year period. Of 107 patients, 97 had simultaneous mixed venous and arterial blood gas measurements available. The CO2 gap was elevated (>6 mmHg) in 51% of the cohort and in 49% of patients with intermediate-risk PE. A reduced CI (≤2.2 L/min/m2) was associated with an increased odds [odds ratio = 7.9; 95% confidence interval (CI) 3.49-18.1, P < 0.001] for an elevated CO2 gap. There was an inverse relationship between the CI and the CO2 gap. For every 1 L/min/m2 decrease in the CI, the CO2 gap increased by 1.3 mmHg (P = 0.001). Among patients with an elevated baseline CO2 gap >6 mmHg, thrombectomy improved the CO2 gap, CI, and mixed venous oxygen saturation. When the CO2 gap was dichotomized above and below 6, there was no difference in the in-hospital mortality rate (9 vs. 0%; P = 0.10; hazard ratio: 1.24; 95% CI 0.97-1.60; P = 0.085). CONCLUSION: Among patients with acute PE undergoing mechanical thrombectomy, the CO2 gap is abnormal in nearly 50% of patients and inversely related to the CI. Further studies should examine the relationship between markers of perfusion and outcomes in this population to refine risk stratification.


Subject(s)
Carbon Dioxide , Pulmonary Embolism , Thrombectomy , Humans , Male , Female , Pulmonary Embolism/blood , Pulmonary Embolism/diagnosis , Retrospective Studies , Carbon Dioxide/blood , Acute Disease , Middle Aged , Aged , Thrombectomy/methods , Blood Gas Analysis/methods , Pulmonary Artery , Cardiac Output/physiology
14.
J Am Heart Assoc ; 13(6): e031979, 2024 Mar 19.
Article in English | MEDLINE | ID: mdl-38456417

ABSTRACT

Cardiogenic shock continues to carry a high mortality rate despite contemporary care, with no breakthrough therapies shown to improve survival over the past few decades. It is a time-sensitive condition that commonly results in cardiovascular complications and multisystem organ failure, necessitating multidisciplinary expertise. Managing patients with cardiogenic shock remains challenging even in well-resourced settings, and an important subgroup of patients may require cardiac replacement therapy. As a result, the idea of leveraging the collective cognitive and procedural proficiencies of multiple providers in a collaborative, team-based approach to care (the "shock team") has been advocated by professional societies and implemented at select high-volume clinical centers. A slowly maturing evidence base has suggested that cardiogenic shock teams may improve patient outcomes. Although several registries exist that are beginning to inform care, particularly around therapeutic strategies of pharmacologic and mechanical circulatory support, none of these are currently focused on the shock team approach, multispecialty partnership, education, or process improvement. We propose the creation of a Cardiogenic Shock Team Collaborative-akin to the successful Pulmonary Embolism Response Team Consortium-with a goal to promote sharing of care protocols, education of stakeholders, and discovery of how process and performance may influence patient outcomes, quality, resource consumption, and costs of care.


Subject(s)
Shock, Cardiogenic , Humans , Shock, Cardiogenic/diagnosis , Shock, Cardiogenic/therapy , Shock, Cardiogenic/etiology
16.
J Crit Care ; 80: 154512, 2024 04.
Article in English | MEDLINE | ID: mdl-38154410

ABSTRACT

Exceeding the limit of pericardial stretch, intrapericardial collections exert compression on the right heart and decrease preload. Compensatory mechanisms ensue to maintain hemodynamics in the face of a depressed stroke volume but are outstripped as disease progresses. When constrained within a pressurized pericardial space, the right and left ventricles exhibit differential filling mediated by changes in intrathoracic pressure. Invasive hemodynamics and echocardiographic findings inform on the physiologic effects. In this review, we describe tamponade physiology and implications for supportive care and effusion drainage.


Subject(s)
Cardiac Tamponade , Humans , Cardiac Tamponade/therapy , Heart , Hemodynamics , Heart Ventricles , Stroke Volume/physiology
17.
Curr Cardiol Rep ; 26(2): 23-34, 2024 02.
Article in English | MEDLINE | ID: mdl-38108956

ABSTRACT

PURPOSE OF REVIEW: To describe medical therapies and mechanical circulatory support devices used in the treatment of acute right ventricular failure. RECENT FINDINGS: Experts have proposed several algorithms providing a stepwise approach to medical optimization of acute right ventricular failure including tailored volume administration, ideal vasopressor selection to support coronary perfusion, inotropes to restore contractility, and pulmonary vasodilators to improve afterload. Studies have investigated various percutaneous and surgically implanted right ventricular assist devices in several clinical settings. The initial management of acute right ventricular failure is often guided by invasive hemodynamic data tracking parameters of circulatory function with the use of pharmacologic therapies. Percutaneous microaxial and centrifugal extracorporeal pumps bypass the failing RV and support circulatory function in severe cases of right ventricular failure.


Subject(s)
Heart Failure , Heart-Assist Devices , Ventricular Dysfunction, Right , Humans , Heart Ventricles , Heart Failure/surgery , Hemodynamics , Perfusion , Treatment Outcome
18.
J Am Heart Assoc ; 12(23): e031530, 2023 Dec 05.
Article in English | MEDLINE | ID: mdl-38038192

ABSTRACT

BACKGROUND: Every year the American Heart Association's Resuscitation Science Symposium (ReSS) brings together a community of international resuscitation science researchers focused on advancing cardiac arrest care. METHODS AND RESULTS: The American Heart Association's ReSS was held in Chicago, Illinois from November 4th to 6th, 2022. This annual narrative review summarizes ReSS programming, including awards, special sessions and scientific content organized by theme and plenary session. CONCLUSIONS: By exploring both the science of resuscitation and important related topics including survivorship, disparities, and community-focused programs, this meeting provided important resuscitation updates.


Subject(s)
Cardiopulmonary Resuscitation , American Heart Association
19.
Case Rep Cardiol ; 2023: 1563732, 2023.
Article in English | MEDLINE | ID: mdl-38026474

ABSTRACT

Amiodarone-induced thyrotoxicosis (AIT) carries significant cardiovascular morbidity. There are two types of AIT with treatment including antithyroid medications and corticosteroids and treatment of ventricular arrhythmias. Therapeutic plasma exchange (TPE) also known as "PLEX" may help remove thyroid hormones and amiodarone. We report a case of PLEX in an attempt to treat cardiogenic shock secondary to AIT. This case highlights the robust rapidly deleterious demise of AIT, specifically in patients with decompensated heart failure. The decision to PLEX or not to PLEX for AIT should be individualized, prior to definitive therapy.

20.
Circ Cardiovasc Interv ; 16(10): e013406, 2023 10.
Article in English | MEDLINE | ID: mdl-37847768

ABSTRACT

BACKGROUND: Hemodynamically unstable high-risk, or massive, pulmonary embolism (PE) has a reported in-hospital mortality of over 25%. Systemic thrombolysis is the guideline-recommended treatment despite limited evidence. The FLAME study (FlowTriever for Acute Massive PE) was designed to generate evidence for interventional treatments in high-risk PE. METHODS: The FLAME study was a prospective, multicenter, nonrandomized, parallel group, observational study of high-risk PE. Eligible patients were treated with FlowTriever mechanical thrombectomy (FlowTriever Arm) or with other contemporary therapies (Context Arm). The primary end point was an in-hospital composite of all-cause mortality, bailout to an alternate thrombus removal strategy, clinical deterioration, and major bleeding. This was compared in the FlowTriever Arm to a prespecified performance goal derived from a contemporary systematic review and meta-analysis. RESULTS: A total of 53 patients were enrolled in the FlowTriever Arm and 61 in the Context Arm. Context Arm patients were primarily treated with systemic thrombolysis (68.9%) or anticoagulation alone (23.0%). The primary end point was reached in 9/53 (17.0%) FlowTriever Arm patients, significantly lower than the 32.0% performance goal (P<0.01). The primary end point was reached in 39/61 (63.9%) Context Arm patients. In-hospital mortality occurred in 1/53 (1.9%) patients in the FlowTriever Arm and in 18/61 (29.5%) patients in the Context Arm. CONCLUSIONS: Among patients selected for mechanical thrombectomy with the FlowTriever System, a significantly lower associated rate of in-hospital adverse clinical outcomes was observed compared with a prespecified performance goal, primarily driven by low all-cause mortality of 1.9%. REGISTRATION: URL: https://www. CLINICALTRIALS: gov; Unique identifier: NCT04795167.


Subject(s)
Pulmonary Embolism , Thrombectomy , Humans , Multicenter Studies as Topic , Observational Studies as Topic , Prospective Studies , Pulmonary Embolism/therapy , Pulmonary Embolism/etiology , Thrombectomy/adverse effects , Thrombectomy/methods , Thrombolytic Therapy/adverse effects , Treatment Outcome
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