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BACKGROUND AND AIMS: Catheter-based therapies (CBTs) have been developed as a treatment option in patients with pulmonary embolism (PE). There remains a paucity of data to inform decision-making in patients with intermediate-risk or high-risk PE. The aim of this study was to characterize in-hospital and readmission outcomes in patients with intermediate-risk or high-risk PE treated with vs. without CBT in a large retrospective registry. METHODS: Patients hospitalized with intermediate-risk or high-risk PE were identified using the 2017-20 National Readmission Database. In-hospital outcomes included death and bleeding and 30- and 90-day readmission outcomes including all-cause, venous thromboembolism (VTE)-related and bleeding-related readmissions. Inverse probability of treatment weighting (IPTW) was utilized to compare outcomes between CBT and no CBT. RESULTS: A total of 14 903 [2076 (13.9%) with CBT] and 42 829 [8824 (20.6%) with CBT] patients with high-risk and intermediate-risk PE were included, respectively. Prior to IPTW, patients with CBT were younger and less likely to have cancer and cardiac arrest, receive systemic thrombolysis, or be on mechanical ventilation. In the IPTW logistic regression model, CBT was associated with lower odds of in-hospital death in high-risk [odds ratio (OR) 0.83, 95% confidence interval (CI) 0.80-0.87] and intermediate-risk PE (OR 0.76, 95% CI 0.70-0.83). Patients with high-risk PE treated with CBT were associated with lower risk of 90-day all-cause [hazard ratio (HR) 0.77, 95% CI 0.71-0.83] and VTE (HR 0.46, 95% CI 0.34-0.63) readmission. Patients with intermediate-risk PE treated with CBT were associated with lower risk of 90-day all-cause (HR 0.75, 95% CI 0.72-0.79) and VTE (HR 0.66, 95% CI 0.57-0.76) readmission. CONCLUSIONS: Among patients with high-risk or intermediate-risk PE, CBT was associated with lower in-hospital death and 90-day readmission. Prospective, randomized trials are needed to confirm these findings.
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Readmisión del Paciente , Embolia Pulmonar , Humanos , Embolia Pulmonar/terapia , Embolia Pulmonar/mortalidad , Masculino , Femenino , Anciano , Estudios Retrospectivos , Persona de Mediana Edad , Readmisión del Paciente/estadística & datos numéricos , Mortalidad Hospitalaria , Sistema de Registros , Hemorragia/terapia , Hemorragia/mortalidad , Medición de Riesgo , Terapia Trombolítica/métodosRESUMEN
OBJECTIVES: Compare in-hospital outcomes of patients treated with either mechanical thrombectomy (MT) or catheter directed lysis (CDL) in treatment of acute pulmonary embolism (PE). METHODS: This is a multicenter, retrospective cohort study of patients undergoing MT or CDL for acute PE between 2014 and 2021. The primary outcome was the composite of in-hospital death, significant bleed, vascular complication, or need for mechanical support post-procedure. Secondary outcomes included the individual components of the composite outcome in addition to blood transfusions, invasive hemodynamics, echocardiographic data, and intensive care unit (ICU) utilization. RESULTS: 458 patients were treated for PE with 266 patients in the CDL arm and 192 patients in the MT arm. The primary composite endpoint was not significantly different between the two groups with CDL 12% versus MT 11% (p = 0.5). There was a significant difference in total length of ICU time required with more in the CDL group versus MT (3.8 ± 2.0 vs. 2.8 ± 3.0 days, p = 0.009). All other secondary end points showed no significant difference between the groups. CONCLUSIONS: In patients undergoing catheter directed treatment of PE, there was no difference between MT and CDL in terms of in-hospital mortality, bleeds, catheter-related complications, and hemodynamics.
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Embolia Pulmonar , Terapia Trombolítica , Humanos , Terapia Trombolítica/métodos , Estudios Retrospectivos , Mortalidad Hospitalaria , Resultado del Tratamiento , Embolia Pulmonar/terapia , Embolia Pulmonar/tratamiento farmacológico , Trombectomía/efectos adversos , Trombectomía/métodos , Catéteres , Hemorragia/inducido químicamente , Fibrinolíticos/efectos adversosRESUMEN
OBJECTIVES: The FlowTriever All-Comer Registry for Patient Safety and Hemodynamics (FLASH) is a prospective multi-center registry evaluating the safety and effectiveness of percutaneous mechanical thrombectomy for treatment of pulmonary embolism (PE) in a real-world patient population (NCT03761173). This interim analysis reports outcomes for the first 250 patients enrolled in FLASH. BACKGROUND: High- and intermediate-risk PEs are characterized by high mortality rates, frequent readmissions, and long-term sequelae. Mechanical thrombectomy is emerging as a front-line therapy for PE that enables immediate thrombus reduction while avoiding the bleeding risks inherent with thrombolytics. METHODS: The primary endpoint is a composite of major adverse events (MAE) including device-related death, major bleeding, and intraprocedural device- or procedure-related adverse events at 48 h. Secondary endpoints include on-table changes in hemodynamics and longer-term measures including dyspnea, heart rate, and cardiac function. RESULTS: Patients were predominantly intermediate-risk per ESC guidelines (6.8% high-risk, 93.2% intermediate-risk). There were three MAEs (1.2%), all of which were major bleeds that resolved without sequelae, with no device-related injuries, clinical deteriorations, or deaths at 48 h. All-cause mortality was 0.4% at 30 days, with a single death that was unrelated to PE. Significant on-table improvements in hemodynamics were noted, including an average reduction in mean pulmonary artery pressure of 7.1 mmHg (22.2%, p < 0.001). Patient symptoms and cardiac function improved through follow-up. CONCLUSIONS: These interim results provide preliminary evidence of excellent safety in a real-world PE population. Reported outcomes suggest that mechanical thrombectomy can result in immediate hemodynamic improvements, symptom reduction, and cardiac function recovery.
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Embolia Pulmonar , Trombectomía , Hemorragia/etiología , Humanos , Estudios Prospectivos , Embolia Pulmonar/terapia , Sistema de Registros , Trombectomía/efectos adversos , Trombectomía/métodos , Resultado del TratamientoRESUMEN
OBJECTIVES: To investigate the invasive hemodynamics in patients with intermediate-risk pulmonary embolism (PE) and the change that occurs with catheter-directed thrombolysis (CDT). BACKGROUND: Intermediate-risk PE is associated with right ventricular strain and worse outcomes yet the invasive hemodynamics have not been well described. METHODS: Ninety-two consecutive patients with intermediate-risk PE referred for CDT at two tertiary medical centers with Pulmonary Embolism Response Teams were included in this prospective cohort study. Hemodynamics at baseline and after CDT therapy was measured. Patients with cardiac index (CI) ≤1.8 L min-1 m-2 were compared to those without shock (CI > 1.8). Linear regression analysis was performed to study the relationship between clinical variables and low CI. RESULTS: Thirty-seven out of 92 (40%) had a CI less than 1.8 L min-1 m-2 . When comparing the low CI to the normal CI groups, most demographics, vital signs, biomarkers, and PE severity index (PESI) scores were similar. The low CI group had more females and slightly lower systolic blood pressures although still in the normal range (122 vs. 132 mmHg, p = .026). Treatment with CDT was associated with significant improvement in CI, heart rate, and pulmonary artery pressures in both groups. Linear regression analysis did not reveal a strong correlation between CI and noninvasive metrics such as heart rate, blood pressure, or PESI score. CONCLUSIONS: Forty percent of patients with submassive PE had a depressed CI and treatment with CDT lead to hemodynamic improvements. Invasive hemodynamics may help better identify higher risk patients and guide therapy.
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Cateterismo Cardíaco , Hemodinámica , Embolia Pulmonar/diagnóstico , Adulto , Anciano , Femenino , Fibrinolíticos/administración & dosificación , Hemodinámica/efectos de los fármacos , Humanos , Masculino , Persona de Mediana Edad , Philadelphia , Valor Predictivo de las Pruebas , Estudios Prospectivos , Embolia Pulmonar/tratamiento farmacológico , Embolia Pulmonar/fisiopatología , Recuperación de la Función , Terapia Trombolítica , Resultado del TratamientoRESUMEN
OBJECTIVE: Examine FlowTriever thrombectomy feasibility in high-risk PE patients. BACKGROUND: The FlowTriever thrombectomy system (Inari Medical, Irvine, CA) can reduce right ventricle (RV) strain in acute submassive pulmonary embolism (PE) patients. This technology has not been studied in higher risk PE patients. METHODS: This multicenter retrospective analysis included patients treated with FlowTriever between 2017 and 2019 if they met at least one of the following: vasopressor dependence, PE induced respiratory failure, or decreased cardiac index (CI) measured by right heart catheterization. RESULTS: Analysis included 34 patients: 18 massive, four intubated, 12 normotensive but with CI < 1.8. Average age was 56 and their median simplified PE severity index was 2. Patients had high bleeding risk, with 13 having recent surgery, six posttrauma, and four recent strokes. Six patients received cardiopulmonary resuscitation, and two received additional mechanical circulatory support. All patients had RV dilatation and elevated biomarkers. Clot removal was successful in 32/34 patients. CI improved from 2.0 ± 0.1 L/min/m2 before thrombectomy to 2.4 ± 0.1 L/min/m2 after (p = .01). The mean pulmonary artery pressure decreased from 33.2 ± 1.6 mmHg to 25.0 ± 1.5 mmHg (p = .01). The two patients-both with no or minimal thrombus removed-deteriorated during the procedure: one died and the other was successfully stabilized on ECMO. There were no other major complications. All other patients were alive at the time of data collection (mean follow-up of 205 days). CONCLUSION: Aspiration thrombectomy appears feasible in higher risk acute PE patients with immediate hemodynamic improvement and low in-hospital mortality.
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Embolia Pulmonar/cirugía , Trombectomía , Enfermedad Aguda , Estudios de Factibilidad , Femenino , Hemodinámica , Mortalidad Hospitalaria , Humanos , Masculino , Persona de Mediana Edad , Embolia Pulmonar/diagnóstico por imagen , Embolia Pulmonar/mortalidad , Embolia Pulmonar/fisiopatología , Recuperación de la Función , Estudios Retrospectivos , Medición de Riesgo , Factores de Riesgo , Trombectomía/efectos adversos , Trombectomía/instrumentación , Trombectomía/mortalidad , Factores de Tiempo , Resultado del Tratamiento , Estados UnidosRESUMEN
Catheter-directed thrombolysis (CDT) and systemic thrombolysis (ST) are used to treat intermediate/high-risk pulmonary embolism (PE) in the absence of comparative safety and effectiveness data. We utilized a large administrative database to perform a comparative safety and effectiveness analysis of catheter-directed versus systemic thrombolysis. From the Optum® Clinformatics® Data Mart private-payer insurance claims database, we identified 100,744 patients hospitalized with PE between 2004 and 2014. We extracted demographic characteristics, high-risk PE features, components of the Elixhauser Comorbidity Index, and outcomes including intracranial hemorrhage (ICH), all-cause bleeding, and mortality among all patients receiving CDT and ST. We used propensity score methods to compare outcomes between matched cohorts adjusted for observed confounders. A total of 1915 patients (1.9%) received either CDT (n = 632) or ST (n = 1283). Patients in the CDT group had fewer high-risk features including less shock (5.4 vs 11.1%; p < 0.001) and cardiac arrest (6.8 vs 11.0%; p = 0.004). In 1:1 propensity-matched groups, ICH rates were 1.9% in both the CDT and ST groups (p = 1.0). All-cause bleeding was higher in the CDT group (15.9 vs 8.7%; p < 0.001), while in-hospital mortality was lower (6.5 vs 10.0%; p = 0.02). Among a nationally representative cohort of patients with PE at higher risk for mortality, CDT was associated with similar ICH rates, increased all-cause bleeding, and lower short and intermediate-term mortality when compared with ST. The competing risks and benefits of CDT in real-world practice suggest the need for large-scale randomized clinical trials with appropriate comparator arms.
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Fibrinolíticos/administración & dosificación , Embolia Pulmonar/tratamiento farmacológico , Terapia Trombolítica , Reclamos Administrativos en el Cuidado de la Salud , Adulto , Anciano , Investigación sobre la Eficacia Comparativa , Bases de Datos Factuales , Femenino , Fibrinolíticos/efectos adversos , Hemorragia/inducido químicamente , Mortalidad Hospitalaria , Humanos , Masculino , Persona de Mediana Edad , Embolia Pulmonar/diagnóstico por imagen , Embolia Pulmonar/mortalidad , Estudios Retrospectivos , Medición de Riesgo , Factores de Riesgo , Terapia Trombolítica/efectos adversos , Terapia Trombolítica/mortalidad , Factores de Tiempo , Resultado del Tratamiento , Estados UnidosRESUMEN
BACKGROUND: Patients requiring lung transplantation (LTx) may also have coronary artery disease (CAD). The peri-operative management and long-term outcomes of these patients are not well established. METHODS: Patients referred for LTx from 2008 to 2014 were included in this study. CAD was defined by angiography as no CAD (stenosis <20%), moderate CAD (20%-69%), and significant CAD (stenosis ≥70%). Revascularization was per recommendations of local heart team. Postoperative cardiovascular outcomes and long-term survival are reported. RESULTS: A total of 1493 patients were screened for LTx during this period and 656 received a transplant. Of the patients that underwent LTx, 51% had no CAD, 33% had moderate non-obstructive CAD, and 16% had obstructive CAD. Forty-three patients underwent revascularization. There was a no increased risk of peri-operative cardiovascular events or for adjusted mortality for patients with obstructive CAD (HR=1.24, 95% CI: 0.83-1.86, P=.290) including those requiring revascularization. CONCLUSIONS: There is a high prevalence of coronary disease in the population of patients with advanced lung disease requiring lung transplantation. Careful evaluation and treatment can allow for patients with all severities of CAD including those requiring revascularization to successfully undergo LTx.
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Enfermedad de la Arteria Coronaria/terapia , Enfermedades Pulmonares/cirugía , Trasplante de Pulmón , Atención Perioperativa/métodos , Adulto , Anciano , Enfermedad de la Arteria Coronaria/complicaciones , Enfermedad de la Arteria Coronaria/diagnóstico , Enfermedad de la Arteria Coronaria/epidemiología , Bases de Datos Factuales , Femenino , Estudios de Seguimiento , Humanos , Modelos Logísticos , Enfermedades Pulmonares/complicaciones , Enfermedades Pulmonares/mortalidad , Masculino , Persona de Mediana Edad , Revascularización Miocárdica , Prevalencia , Análisis de Supervivencia , Resultado del TratamientoRESUMEN
BACKGROUND: Acute coronary syndrome (ACS) complicated by shock is associated with high mortality despite the use of percutaneous support devices. Extracorporeal membrane oxygenation (ECMO) offers cardiopulmonary support but its safety and efficacy in the ACS setting is still under investigation. METHODS: We reviewed the clinical characteristics and course of 18 consecutive patients who received femoral veno-arterial ECMO in the cardiac catheterization lab for severe shock due to ACS at our center between 2007 and 2013. RESULTS: The average age was 59.9 years, 72.2% male. Of the 18 patients, 83% had a ST-segment elevation myocardial infarction, of which 55% had a left main or left anterior descending artery occlusion. Thirteen patients received stents, three were referred for coronary artery bypass grafting alone, and two received balloon angioplasty. All patients received aspirin, a thienopyridine (either clopidogrel or ticagrelor), and heparin. Five patients received a glycoprotein IIb/IIIa inhibitor during the catheterization. The average length of ECMO was 3.2 ± 2.5 days, length of stay was 23.4 days, and 67% survived to discharge. Seventeen of eighteen patients (94%) required at least one blood transfusion and use of blood products was significantly higher in the group receiving glycoprotein IIb/IIIa inhibitors [19 U of packed red blood cells (PRBC) vs. 8.2 U (P = 0.003)]. CONCLUSIONS: In patients with severe shock or refractory ventricular arrhythmias due to ACS, VA-ECMO likely offers an alternative form of biventricular support albeit with significant resource utilization and morbidity. A better understanding of how to manage patients with ACS requiring VA-ECMO support including the associated morbidities such as bleeding is necessary.
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Síndrome Coronario Agudo/terapia , Oxigenación por Membrana Extracorpórea/métodos , Choque Cardiogénico/terapia , Síndrome Coronario Agudo/complicaciones , Femenino , Estudios de Seguimiento , Humanos , Masculino , Persona de Mediana Edad , Estudios Retrospectivos , Choque Cardiogénico/etiología , Resultado del TratamientoRESUMEN
OBJECTIVE: To better characterize intrastent pathology using optical coherence tomography (OCT) in patients presenting with late and very late stent thrombosis (LST/VLST). BACKGROUND: The contribution of specific intrastent pathologies to the development of LST/VLST is not well understood. METHODS: In this single-center, retrospective, observational study of 796 consecutive patients treated for ST-segment elevation myocardial infarction (STEMI) with primary PCI we identified 57 patients (7.2%) in whom STEMI resulted from LST/VLST. Of the patients with LST/VLST, 21 patients (37%) had OCT performed at the discretion of the operator during PCI for LST/VLST. Independent reviewers performed qualitative offline analysis of OCT images to determine the cause of stent thrombosis defined as the specific intrastent pathology associated with thrombus deposition. RESULTS: The principal intrastent pathology causing LST/VLST was determined to be stent malapposition in 11 patients (55%), of which 5 (25% of all LST/VLST patents) had findings suggestive of positive vessel remodeling. Neoatherosclerosis was determined to be the cause of LST/VLST in 7 patients (35%). LST/VLST resulted from uncovered stent struts in 2 patients (10%). Among all LST/VLST patients, in-hospital mortality (12.3%) and post-hospital target vessel failure (TVF) or cardiac death (21.7%, median follow-up 1.6 years) remained high. There was a trend towards decreased TVF or cardiac death (7.7% vs. 27.3% P = 0.24) in patients who underwent OCT-guided therapy. CONCLUSIONS: LST/VLST remains a significant cause of STEMI and is associated with considerable morbidity and mortality. OCT use at the time of PCI consistently identifies significant intrastent pathology with potentially meaningful clinical impact.
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Reestenosis Coronaria , Stents Liberadores de Fármacos/efectos adversos , Infarto del Miocardio/terapia , Intervención Coronaria Percutánea/efectos adversos , Trombosis , Anciano , Reestenosis Coronaria/diagnóstico , Reestenosis Coronaria/etiología , Reestenosis Coronaria/mortalidad , Femenino , Estudios de Seguimiento , Humanos , Masculino , Persona de Mediana Edad , Infarto del Miocardio/diagnóstico , Intervención Coronaria Percutánea/instrumentación , Intervención Coronaria Percutánea/métodos , Reproducibilidad de los Resultados , Retratamiento/métodos , Retratamiento/estadística & datos numéricos , Estudios Retrospectivos , Análisis de Supervivencia , Trombosis/diagnóstico , Trombosis/etiología , Factores de Tiempo , Tomografía de Coherencia Óptica/métodos , Estados Unidos/epidemiologíaRESUMEN
BACKGROUND: Contemporary care patterns/outcomes in high-risk pulmonary embolism (PE) patients are unknown. OBJECTIVES: This study sought to characterize the management of high-risk PE patients and identify factors associated with poor outcomes. METHODS: A retrospective analysis of the PERT (Pulmonary Embolism Response Team) Consortium Registry was performed. Patients presenting with intermediate-risk PE, high-risk PE, and catastrophic PE (those with hemodynamic collapse) were identified. Patient characteristics were compared with chi-square testing for categorical covariates and Student's t-test for continuous covariates. Multivariable logistic regression was used to assess associations between clinical characteristics and outcomes in the high-risk population. RESULTS: Of 5,790 registry patients, 2,976 presented with intermediate-risk PE and 1,442 with high-risk PE. High-risk PE patients were more frequently treated with advanced therapies than intermediate-risk PE patients (41.9% vs 30.2%; P < 0.001). In-hospital mortality (20.6% vs 3.7%; P < 0.001) and major bleeding (10.5% vs. 3.5%; P < 0.001) were more common in high-risk PE. Multivariable regression analysis demonstrated vasopressor use (OR: 4.56; 95% CI: 3.27-6.38; P < 0.01), extracorporeal membrane oxygenation use (OR: 2.86; 95% CI: 1.12-7.30; P = 0.03), identified clot-in-transit (OR: 2.26; 95% CI: 1.13-4.52; P = 0.02), and malignancy (OR: = 1.70; 95% CI: 1.13-2.56; P = 0.01) as factors associated with in-hospital mortality. Catastrophic PE patients (n = 197 [13.7% of high-risk PE patients]) had higher in-hospital mortality (42.1% vs 17.2%; P < 0.001) than those presenting with noncatastrophic high-risk PE. Extracorporeal membrane oxygenation (13.3% vs. 4.8% P < 0.001) and systemic thrombolysis (25% vs 11.3%; P < 0.001) were used more commonly in catastrophic PE. CONCLUSIONS: In the largest analysis of high-risk PE patients to date, mortality rates were high with the worst outcomes among patients with hemodynamic collapse.
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Hemorragia , Embolia Pulmonar , Humanos , Estudios Retrospectivos , Factores de Riesgo , Hemorragia/etiología , Modelos Logísticos , Embolia Pulmonar/terapia , Terapia Trombolítica/efectos adversos , Resultado del TratamientoRESUMEN
Background: Catheter-directed thrombolysis (CDT) and large-bore mechanical thrombectomy (MT) are the leading percutaneous-based therapies for the management of intermediate-risk pulmonary embolism (PE). While previous studies have demonstrated their procedural safety and efficacy, the cost implications of these interventions remain unclear. This study aims to conduct a cost-benefit analysis to evaluate the economic advantages associated with CDT and MT from the perspective of the treating hospital. Methods: A total of 372 consecutive patients with intermediate-risk acute PE who underwent either MT or CDT at 3 academic centers between 2013 and 2021 were included in this analysis. The costs of care incurred during the index hospitalization for the 2 treatment groups were collected and compared using an adjusted cost model. Results: This study compared the hospital costs of 226 patients who underwent CDT and 146 patients who underwent MT. In the unadjusted overall cohort, the use of CDT was associated with a numerical but nonsignificant increase in costs amounting to $5120 relative to MT (P = .062). This cost difference was primarily driven by the longer length of stay in the intensive care unit and hospital for CDT patients, particularly earlier in the studied timeframe. However, when accounting for confounders including variations between the treating institutions and the timing of treatment during the study period, the adjusted cost differential between CDT and MT narrowed to $1351 (P = .71). Conclusions: This multicenter cost analysis does not reveal a clear cost advantage of 1 treatment over the other for intermediate-risk PE. The observed cost differences were influenced by variations in practice patterns across the study period and among the 3 participating institutions. Future efforts should also focus on strategies to reduce the length of stay, improve efficiency, and minimize the overall cost of care for intermediate-risk PE patients.
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BACKGROUND: Patients with acute pulmonary embolism (PE) and hypotension (high-risk PE) have high mortality. Cardiogenic shock can also occur in nonhypotensive or normotensive patients (intermediate-risk PE) but is less well characterized. OBJECTIVES: The authors sought to evaluate the prevalence and predictors of normotensive shock in intermediate-risk PE. METHODS: Intermediate-risk PE patients in the FLASH (FlowTriever All-Comer Registry for Patient Safety and Hemodynamics) registry undergoing mechanical thrombectomy with the FlowTriever System (Inari Medical) were included. The prevalence of normotensive shock (systolic blood pressure ≥90 mm Hg but cardiac index ≤2.2 L/min/m2) was assessed. A composite shock score consisting of markers of right ventricular function and ischemia (elevated troponin, elevated B-type natriuretic peptide, moderately/severely reduced right ventricular function), central thrombus burden (saddle PE), potential additional embolization (concomitant deep vein thrombosis), and cardiovascular compensation (tachycardia) was prespecified and assessed for its ability to identify normotensive shock patients. RESULTS: Over one-third of intermediate-risk PE patients in FLASH (131/384, 34.1%) were in normotensive shock. The normotensive shock prevalence was 0% in patients with a composite shock score of 0 and 58.3% in those with a score of 6 (highest score). A score of 6 was a significant predictor of normotensive shock (odds ratio: 5.84; 95% CI: 2.00-17.04). Patients showed significant on-table improvements in hemodynamics post-thrombectomy, including normalization of the cardiac index in 30.5% of normotensive shock patients. Right ventricular size, function, dyspnea, and quality of life significantly improved at the 30-day follow-up. CONCLUSIONS: Although hemodynamically stable, over one-third of intermediate-risk FLASH patients were in normotensive shock with a depressed cardiac index. A composite shock score effectively further risk stratified these patients. Mechanical thrombectomy improved hemodynamics and functional outcomes at the 30-day follow-up.
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Embolia Pulmonar , Choque Cardiogénico , Humanos , Choque Cardiogénico/diagnóstico , Choque Cardiogénico/epidemiología , Choque Cardiogénico/terapia , Resultado del Tratamiento , Prevalencia , Calidad de Vida , Estudios Retrospectivos , Embolia Pulmonar/diagnóstico por imagen , Embolia Pulmonar/epidemiologíaRESUMEN
Background: The relationship between the early hemodynamic consequences of acute pulmonary embolism (PE) and short-term morbidity and mortality has long been recognized. The mortality incidence and other complications after high-risk (massive) PE, the most severe category of the disease, are summarized in this meta-analysis. Methods: A systematic review and meta-analysis of studies reporting on patients with massive PE indexed by PubMed and the Cochrane Library over a 10-year period (2010-2020) was conducted. Studies with adequate information to specify a cohort of patients with high-risk PE defined by the American Heart Association and European Society of Cardiology criteria and their clinical outcomes were included. Incidences were calculated as weighted averages with 95% CIs. Results: A total of 27 publications spanning 1517 patients were identified that met the search criteria for high-risk PE. In-hospital all-cause mortality averaged 28.3% (95% CI, 20.9%-37.0%) in patients at high risk, comparable to the 30-day all-cause mortality of 30.2% (95% CI, 22.3%-39.6%). In-hospital major bleeding was 13.8% (95% CI, 9.3%-20.0%), and intracranial hemorrhage was reported in 3.6% (95% CI, 2.2%-5.9%). The risk of bias in publications was graded as low-to-moderate, with substantial heterogeneity among the studies. Conclusions: This systematic review and meta-analysis provided low-quality to moderate-quality evidence documenting mortality, major bleeding, and other complications in patients meeting the American Heart Association and European Society of Cardiology criteria for high-risk PE. This information was used to inform the design of the FLowTriever for Acute Massive Pulmonary Embolism (FLAME) study (NCT04795167), a study evaluating an advanced therapy for patients with high-risk PE.
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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.
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Embolia Pulmonar , Trombectomía , Humanos , Estudios Multicéntricos como Asunto , Estudios Observacionales como Asunto , Estudios Prospectivos , Embolia Pulmonar/terapia , Embolia Pulmonar/etiología , Trombectomía/efectos adversos , Trombectomía/métodos , Terapia Trombolítica/efectos adversos , Resultado del TratamientoRESUMEN
Background: Mechanical thrombectomy provides rapid hemodynamic improvements after acute pulmonary embolism (PE), but long-term benefits are uncertain. Methods: FlowTriever All-comer Registry for Patient Safety and Hemodynamics is a prospective, single-arm, multicenter registry of patients with acute PE treated with the FlowTriever System (Inari Medical). Six-month outcomes including modified Medical Research Council dyspnea scores (MMRCD), right ventricular (RV) function, 6-minute walk test distances, and PE quality-of-life scores (QoL) were assessed. Results: In total, 799 patients were enrolled and 75% completed the study with a mean follow-up of 204 ± 46 days. Demographic characteristics included 54.1% men, mean age of 61.2 years, 77.1% intermediate-high-risk PE, and 8.0% high-risk PE. All-cause mortality was 4.6% at study completion. The proportion of patients with normal echocardiographic RV function increased from 15.1% at baseline to 95.1% at 6 months (P < .0001). MMRCD score improved from 3.0 at baseline to 0.0 at 6 months (P < .0001). 6-minute walk test distances increased from 180 m at 48 hours to 398 m at 6 months (P < .001). Median PE QoL total scores were 9.38 at 30 days and 4.85 at 6 months (P < .001). Prevalence of site-reported chronic thromboembolic pulmonary hypertension was 1.0% and chronic thromboembolic disease was 1.9%. Conclusions: In this large diverse group of PE patients, 6-month all-cause mortality, chronic thromboembolic pulmonary hypertension, and chronic thromboembolic disease were low following thrombectomy with the FlowTriever system. Significant improvements in RV function, patient symptoms, exercise capacity, and QoL were observed at 6 months, suggesting that rapid extraction of thrombus may prevent long-term sequelae in patients with PE.
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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<0.0001) and a 0.3 L/min/m2 mean increase in cardiac index (18.9%; p<0.0001) in patients with depressed baseline values. Most patients (62.6%) had no overnight intensive care unit stay post-procedure. At 48 hours, the echocardiographic right ventricle/left ventricle ratio decreased from 1.23±0.36 to 0.98±0.31 (p<0.0001 for paired values) and patients with severe dyspnoea decreased from 66.5% to 15.6% (p<0.0001). 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.
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Embolia Pulmonar , Trombectomía , Humanos , Trombectomía/métodos , Resultado del Tratamiento , Embolia Pulmonar/terapia , Fibrinolíticos/uso terapéutico , Sistema de Registros , Terapia Trombolítica/métodosRESUMEN
UNLABELLED: Calcineurin inhibitor (CNI)-associated renal insufficiency is common after cardiac transplantation (CTX); however, the addition of sirolimus allows for CNI dose reduction and this strategy may limit CNI renal toxicity. This study examines the long-term effects of such a strategy. METHODS: Patients from a single center who had CTX from 1990 to 2007 and who were converted to sirolimus and a dose-reduced CNI were compared to group-matched controls maintained on CNI and an antiproliferative agent. RESULTS: One hundred and fifty-five patients (79 sirolimus and 76 controls) were included and had similar baseline characteristics. Sirolimus was started a mean of 1429 d post-CTX and maintained for a mean of 823 d. Reason for conversion to sirolimus was renal insufficiency (34%), vasculopathy (29%), recurrent rejection (19%), and other (18%). The eGFR was not different between groups at baseline (44.7 mL/min/1.73 m(2) vs. 46.0, p = 0.64) or at any point during follow-up: 90 d, 180 d, 1 yr, 2 yr, and 3 yr. conclusion: Patients converted to a regimen of sirolimus and a dosed-reduced CNI have stable renal function over the following three yr, but do not have an improvement in renal outcomes compared to patients maintained on full dose CNI.
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Inhibidores de la Calcineurina , Rechazo de Injerto/prevención & control , Trasplante de Corazón/efectos adversos , Inmunosupresores/uso terapéutico , Fallo Renal Crónico/tratamiento farmacológico , Sirolimus/uso terapéutico , Estudios de Casos y Controles , Femenino , Tasa de Filtración Glomerular , Trasplante de Corazón/inmunología , Humanos , Fallo Renal Crónico/etiología , Pruebas de Función Renal , Masculino , Persona de Mediana Edad , Pronóstico , Estudios Prospectivos , Estudios Retrospectivos , TiempoRESUMEN
Right ventricular assist devices (RVADs) can be used in patients with acute right heart failure. A novel device that has recently been deployed is the right atrium to pulmonary artery (RA-PA) dual lumen single cannula (DLSC). One of the limitations is that it occupies a large proportion of the right ventricular outflow tract and PA; therefore, standard continuous hemodynamic monitoring with a pulmonary artery catheter is commonly not used. Serial echocardiography is pivotal for device deployment, monitoring device position, assessing RV readiness for decannulation, and surveilling for short-term complications. We performed a retrospective case series of 24 patients with RA-PA DLSC RVAD assessing echocardiographic RV progression and vasoactive infusion requirements. The overall survival was 66.6%. The average vasoactive infusion score at the time of cannulation was 24.9 ± 43.9, at decannulation in survivors 4.6 ± 4.9 vs . 25.4 ± 21.5 in nonsurvivors, and 2.7 ± 4.9 at 48 hours post decannulation. On echocardiography, the average visual estimate of RV systolic function encoded (0 = none and 5 = severe) in survivors was 3.9 ± 1.2, 2.8 ± 1.6, 2.5 ± 1.7, and 2.8 ± 1.9, respectively, and in nonsurvivors 3.8 ± 1.6 and 3.4 ± 1.8, respectively. This demonstrated an RV systolic function improvement over time in survivors as opposed to nonsurvivors. This was also demonstrated in RV size visual estimate, respectively. Quantitatively, at the predefined four timepoints, the RV:LV, tricuspid annular plane systolic excursion, and fractional area change all improve over time and there is statistically significant difference in survivors versus nonsurvivors. In this study, we describe a cohort of patients treated with RA-PA DLSC RVAD. We illustrate the critical nature of echocardiographic measures to rate the progression of RV function, improvement in vasoactive infusion requirements, and ventilator parameters with the RA-PA DLSC.
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Insuficiencia Cardíaca , Corazón Auxiliar , Disfunción Ventricular Derecha , Humanos , Corazón Auxiliar/efectos adversos , Arteria Pulmonar , Estudios Retrospectivos , Insuficiencia Cardíaca/cirugía , Insuficiencia Cardíaca/complicaciones , Atrios Cardíacos/diagnóstico por imagen , Disfunción Ventricular Derecha/diagnóstico por imagen , Disfunción Ventricular Derecha/etiologíaRESUMEN
OBJECTIVE: We aimed to assess the intermediate-term outcomes for patients receiving catheter-directed thrombolysis (CDT) for submassive pulmonary embolism (PE). BACKGROUND: Previous research has shown improvements in right ventricular (RV) function and dilation at 24 hours when CDT was used to treat submassive PE. METHODS: Consecutive patients presenting with submassive PE treated with directed t-PA infusion at a single center were identified and included in this study. Outcomes included cardiovascular mortality, RV function by echocardiogram, 30-day readmission, and major bleeding. RESULTS: The study population was 79 patients with submassive PE; 46% were men, with an average age of 58 years and an average pulmonary embolism severity index (PESI) score of 108. One patient died of cardiovascular causes during the index hospitalization. There were no additional deaths within 30 days of admission. The observed 30-day mortality rate was low compared with that predicted by PESI (1.3% vs 4.0%-11.4%). Fifty-two patients had follow-up echocardiography available for evaluation after CDT. Of these, 62% showed return to normal RV function and size, and 19% demonstrated mild residual RV dysfunction or dilation. Eight patients (10%) had a hospital readmission within 30 days of discharge, including 6 admissions due to cardiopulmonary complications or minor bleeding and 2 for non-cardiopulmonary or bleeding-related reasons. The observed readmission rate of 10% was similar to historic rates of 12.8%. CONCLUSIONS: Intermediate-term follow-up for CDT demonstrates high success rates with low adverse event rates. Further randomized data are needed to study the long-term benefits of CDT.
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Embolia Pulmonar , Catéteres , Humanos , Persona de Mediana Edad , Embolia Pulmonar/diagnóstico , Embolia Pulmonar/tratamiento farmacológico , Terapia TrombolíticaRESUMEN
Pulmonary embolism (PE) is the third leading cause of cardiovascular mortality. The management of PE is currently evolving given the development of new technologies and team-based approaches. This document will focus on risk stratification of PEs, review of the current interventional therapies, the role of clinical endpoints to assess the effectiveness of different interventional therapies, and the role for mechanical circulatory support in the complex management of this disease.