| 1. Tsao CW, Aday AW, Almarzooq ZI, et al. Heart Disease and Stroke Statistics-2023 Update: A Report From the American Heart Association. Circulation 2023;147:e93-e621. |
Review/Other-Tx |
N/A |
To present the latest data on a range of major clinical heart and circulatory disease conditions (including stroke, congenital heart disease, rhythm disorders, subclinical atherosclerosis, coronary heart disease, heart failure, valvular disease, venous disease, and peripheral artery disease) and the associated outcomes (including quality of care, procedures, and economic costs). |
No abstract available. |
4 |
| 2. Turetz M, Sideris AT, Friedman OA, Triphathi N, Horowitz JM. Epidemiology, Pathophysiology, and Natural History of Pulmonary Embolism. Semin Intervent Radiol 2018;35:92-98. |
Review/Other-Dx |
N/A |
To identify the disease burden of pulmonary embolism, as well as the progression of the disease with and without treatment, and potential for long-term disability |
No results stated in abstract. |
4 |
| 3. Porfidia A, Valeriani E, Pola R, Porreca E, Rutjes AWS, Di Nisio M. Venous thromboembolism in patients with COVID-19: Systematic review and meta-analysis. Thromb Res 2020;196:67-74. |
Meta-analysis |
3487 patients from 30 studies |
To evaluate the incidence of VTE in patients with COVID-19. |
Based on very low-quality evidence due to heterogeneity and risk of bias, the incidence of VTE was 26% (95% PI, 6%-66%). PE with or without DVT occurred in 12% of patients (95% PI, 2%-46%) and DVT alone in 14% (95% PI, 1%-75%). Studies using standard algorithms for clinically suspected VTE reported PE in 13% of patients (95% PI, 2%-57%) and DVT in 6% (95% PI, 0%-60%), compared to 11% (95% PI, 2%-46%) and 24% (95% PI, 2%-85%) in studies using other diagnostic strategies or patient sampling. In patients admitted to intensive care units, VTE occurred in 24% (95% PI, 5%-66%), PE in 19% (95% PI, 6%-47%), and DVT alone in 7% (95% PI, 0%-69%). Corresponding values in general wards were respectively 9% (95% PI, 0%-94%), 4% (95% PI, 0%-100%), and 7% (95% CI, 1%-49%). |
Good |
| 4. Kirsch J, Wu CC, Bolen MA, et al. ACR Appropriateness Criteria® Suspected Pulmonary Embolism: 2022 Update. J Am Coll Radiol 2022;19:S488-S501. |
Review/Other-Dx |
N/A |
Evidence-based guidelines to assist referring physicians and other providers in making the most appropriate imaging or treatment decision for suspected pulmonary embolism. |
No results stated in abstract. |
4 |
| 5. Konstantinides SV, Meyer G, Becattini C, et al. 2019 ESC Guidelines for the diagnosis and management of acute pulmonary embolism developed in collaboration with the European Respiratory Society (ERS): The Task Force for the diagnosis and management of acute pulmonary embolism of the European Society of Cardiology (ESC). European Respiratory Journal. 54(3), 2019 09. |
Review/Other-Dx |
N/A |
To focus on the diagnosis and management of acute PE in adult patients. |
No abstract available. |
4 |
| 6. Giri J, Sista AK, Weinberg I, et al. Interventional Therapies for Acute Pulmonary Embolism: Current Status and Principles for the Development of Novel Evidence: A Scientific Statement From the American Heart Association. [Review]. Circulation. 140(20):e774-e801, 2019 11 12. |
Review/Other-Dx |
N/A |
To review the definitions and limitations of commonly used risk stratification tools for PE.To review risks and benefits of available interventional therapies for PE.To present considerations for optimal future evidence development in this field in the context of the current US regulatory framework.To discuss the pros and cons of the rapidly expanding PE response team model of care delivery. |
No results stated in abstract. |
4 |
| 7. Triantafyllou GA, O'Corragain O, Rivera-Lebron B, Rali P. Risk Stratification in Acute Pulmonary Embolism: The Latest Algorithms. [Review]. Seminars in Respiratory & Critical Care Medicine. 42(2):183-198, 2021 04. |
Review/Other-Dx |
N/A |
To review the latest algorithms for a comprehensive risk stratification of the patient with acute PE. |
No results stated in abstract. |
4 |
| 8. Chopard R, Campia U, Morin L, et al. Trends in management and outcomes of pulmonary embolism with a multidisciplinary response team. Journal of Thrombosis & Thrombolysis. 54(3):449-460, 2022 Oct. |
Observational-Tx |
425 patients |
To describe temporal trends in PE management and outcomes following the deployment of multidisciplinary pulmonary embolism (PE) response teams. |
We observed an increase in PE acuity and use of systemic thrombolysis. The primary endpoint at 30 days decreased from 16.3% in 2015 to 7.1% in 2019 (adjusted rate ratio per period, 0.63; 95%CI, 0.47-0.84), driven by a decrease in the adjusted rate of major bleeding. Among 406 patients with complete follow-up, the adjusted rate ratio per year for the primary outcome at 6 months was 0.37 (95%CI, 0.19-0.71), driven by a decrease in all-cause mortality. |
2 |
| 9. Hussein EA, Semaan DB, Phillips AR, et al. Pulmonary embolism response team for hospitalized patients with submassive and massive pulmonary embolism: A single-center experience. Journal of Vascular Surgery. 11(4):741-747.e2, 2023 Jul. |
Observational-Tx |
5190 patients (819 = PERT group, 4371 = nonPERT group) |
To describe the experience of a large multihospital single-network institution with multidisciplinary PE response teams (PERT). |
We analyzed 5190 patients, with 819 (15.8%) being in the PERT group. Patients in the PERT group were more likely to receive extensive workup that included troponin-I (66.3% vs 42.3%; P < .001) and brain natriuretic peptide (50.4% vs 20.3%; P < .001). They also more often received catheter-directed interventions (12% vs 6.2%; P < .001) rather than anticoagulation monotherapy. Mortality outcomes were similar between both groups at all measured timepoints. Rates of ICU admission (65.2% vs 29.7%; P < .001), ICU LOS (median, 64.7 hours; interquartile range [IQR], 41.9-89.1 hours vs median, 38 hours; IQR, 22-66.4 hours; P < .001), and total hospital LOS (median, 5 days; IQR, 3-8 days vs median, 4 days; IQR, 2-6 days; P < .001) were all higher among the PERT group. Patients in the PERT group were more likely to receive vascular surgery consultation (5.3% vs 0.8%; P < .001) and the consultation occurred earlier in the admission when compared with the non-PERT group (median, 0 days; IQR, 0-1 days vs median, 1 day; IQR, 0-1; P = .04). |
2 |
| 10. Stevens SM, Woller SC, Baumann Kreuziger L, et al. Executive Summary: Antithrombotic Therapy for VTE Disease: Second Update of the CHEST Guideline and Expert Panel Report. Chest. 160(6):2247-2259, 2021 12. |
Review/Other-Tx |
N/A |
To provide recommendations on 17 PICO (Population, Intervention, Comparator, Outcome) questions, four of which have not been addressed previously. |
The panel generated 29 guidance statements, 13 of which are graded as strong recommendations, covering aspects of antithrombotic management of VTE from initial management through secondary prevention and risk reduction of postthrombotic syndrome. Four new guidance statements have been added that did not appear in the 9th edition (2012) or 1st update (2016). Eight statements have been substantially modified from the 1st update. |
4 |
| 11. Kuo WT, Banerjee A, Kim PS, et al. Pulmonary Embolism Response to Fragmentation, Embolectomy, and Catheter Thrombolysis (PERFECT): Initial Results From a Prospective Multicenter Registry. Chest. 148(3):667-673, 2015 Sep. |
Observational-Tx |
101 patients with acute massive or submassive PE |
To evaluated the safety and effectiveness of catheter-directed therapy (CDT) as an alternative treatment of acute PE. |
Fifty-three men and 48 women (average age, 60 years [range, 22-86 years]; mean BMI, 31.03 ± 7.20 kg/m 2 ) were included in the study. The average thrombolytic doses were 28.0 ± 11 mg tPA (n = 76) and 2,697,101 ± 936,287 International Units for urokinase (n = 23). Clinical success was achieved in 24 of 28 patients with massive PE (85.7%; 95% CI, 67.3%- 96.0%) and 71 of 73 patients with submassive PE (97.3%; 95% CI, 90.5%-99.7%). The mean pulmonary artery pressure improved from 51.17 ± 14.06 to 37.23 ±15.81 mm Hg (n 5 92) ( P < .0001). Among patients monitored with follow-up echocardiography, 57 of 64 (89.1%; 95% CI, 78.8%-95.5%; P < .0001) showed improvement in right-sided heart strain. There were no major procedure-related complications, major hemorrhages, or hemorrhagic strokes. |
2 |
| 12. Piazza G, Hohlfelder B, Jaff MR, et al. A Prospective, Single-Arm, Multicenter Trial of Ultrasound-Facilitated, Catheter-Directed, Low-Dose Fibrinolysis for Acute Massive and Submassive Pulmonary Embolism: The SEATTLE II Study. JACC Cardiovasc Interv. 8(10):1382-1392, 2015 Aug 24. |
Observational-Tx |
150 patients with CT-confirmed PE |
To evaluate the safety and efficacy of ultrasound-facilitated, catheter-directed, low-dose fibrinolysis, using the EkoSonic Endovascular System (EKOS, Bothell, Washington). |
Mean RV/LV diameter ratio decreased from baseline to 48 h post-procedure (1.55 vs. 1.13; mean difference, -0.42; p < 0.0001). Mean pulmonary artery systolic pressure (51.4 mm Hg vs. 36.9 mm Hg; p < 0.0001) and modified Miller Index score (22.5 vs. 15.8; p < 0.0001) also decreased post-procedure. One GUSTO (Global Utilization of Streptokinase and Tissue Plasminogen Activator for Occluded Coronary Arteries)-defined severe bleed (groin hematoma with transient hypotension) and 16 GUSTO-defined moderate bleeding events occurred in 15 patients (10%). No patient experienced intracranial hemorrhage. |
2 |
| 13. Toma C, Jaber WA, Weinberg MD, et al. Acute outcomes for the full US cohort of the FLASH mechanical thrombectomy registry in pulmonary embolism. EuroIntervention. 18(14):1201-1212, 2023 Feb 20. |
Observational-Tx |
800 PE patients from the U.S. |
To evaluate the acute safety and effectiveness of mechanical thrombectomy for intermediate- and high-risk PE in a large real-world population. |
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). |
2 |
| 14. Klok FA, Piazza G, Sharp ASP, et al. Ultrasound-facilitated, catheter-directed thrombolysis vs anticoagulation alone for acute intermediate-high-risk pulmonary embolism: Rationale and design of the HI-PEITHO study. Am Heart J. 251:43-53, 2022 09. |
Observational-Tx |
27 patients |
To assess whether USCDT plus anticoagulation is associated with a significant reduction in the composite outcome of PE-related mortality, cardiorespiratory decompensa- tion or collapse, or non-fatal symptomatic and objectively confirmed PE recurrence compared to anticoagulation alone, within 7 days of randomization. To contribute further evidence on the treatment and outcomes of acute intermediate-high-risk PE.To provide controlled data comparing a catheter-based in- tervention to the standard of care. |
Patients with: (1) confirmed acute PE; (2) evidence of right ventricular (RV) dysfunction on imaging; (3) a positive cardiac troponin test; and (4) clinical criteria indicating an elevated risk of early death or imminent hemodynamic collapse, will be randomized 1:1 to treatment with a standardized protocol of ultrasound-facilitated catheter-directed thrombolysis plus anticoagulation, vs anticoagulation alone. The primary outcome is a composite of PE-related mortality, cardiorespiratory decompensation or collapse, or non-fatal symptomatic and objectively confirmed PE recurrence, within 7 days of randomization. Further assessments cover, apart from bleeding complications, a broad spectrum of functional and patient-reported outcomes including quality of life indicators, functional status and the utilization of health care resources over a 12-month follow-up period. The trial plans to include 406 patients, but the adaptive design permits a sample size increase depending on the results of the predefined interim analysis. As of May 11, 2022, 27 subjects have been enrolled. The trial is funded by Boston Scientific Corporation and through collaborative research agreements with University of Mainz and The PERT Consortium. |
1 |
| 15. Kaese S, Lebiedz P. Extracorporeal life support after failure of thrombolysis in pulmonary embolism. Advances in Respiratory Medicine. 88(1):13-17, 2020. |
Review/Other-Tx |
12 patients with severe PE |
To study the use of ECLS after thrombolysis in patients suffering from refractory cardiogenic shock due to PE. |
12 patients with severe PE were included. 6 patients were admitted by emergency medical services, 5 patients were transferred to the ICU from other hospitals and one patient presented at the emergency department by herself. 11 of 12 patients suffered from cardiac arrest and needed cardiopulmonary resuscitation (CPR) before ECLS implantation. Three ECLS were im-planted during CPR and nine ECLS were implanted during emergency conditions in patients with cardiogenic shock. All patients received thrombolysis before implementation of ECLS. Mean duration of ICU treatment was 22.4 ± 23.0 days. Mean duration of ECLS therapy was 5.6 ± 6.5 days. Bleeding complications occurred in four patients. Complications directly related to the ECLS system occurred in two patients (overall complication rate 42%). Overall, 6 of 12 patients (50%) survived. |
4 |
| 16. Guliani S, Das Gupta J, Osofsky R, et al. Venoarterial extracorporeal membrane oxygenation is an effective management strategy for massive pulmonary embolism patients. Journal of Vascular Surgery. 9(2):307-314, 2021 03. |
Observational-Tx |
17 consecutive patients |
To review our institution's pulmonary embolism response team experience using VA-ECMO for patients presenting with advanced shock and/or cardiac arrest from MPE. |
The mean patient age and body mass index was 55.8 years and 31.8, respectively. Ten of 17 patients (59%) required cardiopulmonary resuscitation before or during VA-ECMO cannulation. All patients had evidence of profound shock with a mean initial lactate of 8.95 mmol/L, a mean pH of 7.10, and a mean serum creatinine of 1.78 mg/dL. Seventeen of 17 cannulations (100%) were performed percutaneously, with 41% (n = 7) of patients placed on VA-ECMO while awake and using local analgesia. Five of 17 patients (29%) required reperfusion cannulas, with 0% incidence of limb loss. Overall survival was 13 of 17 patients (76%), with causes of death resulting from anoxic brain injury (n = 2), septic shock (n = 1), and cardiopulmonary resuscitation-induced hemorrhage from liver laceration (n = 1). In survivors, 12 of 13 patients (92%) were discharged without evidence of neurologic insult. The median duration of the VA-ECMO run for survivors was 86 hours (range, 45-218 hours). In survivors, the median length of time from ECMO cannulation to lactate clearance (<2.0 mmol/L) was 10 hours and the median length of time from ECMO cannulation to freedom from vasopressors was 6 hours. Three of 13 patients (23%) required concomitant percutaneous thrombectomy and catheter-directed thrombolysis to address persistent right heart dysfunction, with the remaining survivors (77%) receiving VA-ECMO and anticoagulation alone as definitive therapy for their MPE. The median intensive care and hospital length of stay for survivors was 9 and 13 days, respectively. |
2 |
| 17. Prasad NK, Boyajian G, Tran D, et al. Veno-Arterial Extracorporeal Membrane Oxygenation for Pulmonary Embolism after Systemic Thrombolysis. Seminars in Thoracic & Cardiovascular Surgery. 34(2):549-557, 2022Summer. |
Observational-Tx |
83 patients with PE |
To analyze the outcomes of patients who received VA-ECMO in the setting of systemic thrombolytics (ST). |
A total of 83 patients with PE required VA-ECMO support and 18 of these received systemic thrombolytics. There was no statistically significant difference in survival to discharge between the patients who received ST compared with those who did not (88.9% vs 84.6%; p = 0.94). Major bleeding events occurred more often in patients who received ST (61.1% vs 26.2%; p = 0.01). There was no significant difference in time on mechanical ventilation, need for renal replacement therapy, or length of stay between the groups. Reasonable survival can be achieved despite an increased frequency of major bleeding events in patients that receive ST prior to VA-ECMO for PE. ST administration should not be considered an absolute contraindication to VA-ECMO. Further multi-center studies are needed to corroborate these findings. |
2 |
| 18. Azari A, Beheshti AT, Moravvej Z, Bigdelu L, Salehi M. Surgical embolectomy versus thrombolytic therapy in the management of acute massive pulmonary embolism: Short and long-term prognosis. Heart & Lung. 44(4):335-9, 2015 Jul-Aug. |
Observational-Tx |
78 patients with acute massive unilateral or bilateral pulmonary
embolism |
To analyze the short and long-term results in patients suffering from AMPE treated with either surgical embolectomy or thrombolytic therapy over an 8-year period. |
Seventy eight patients were treated with thrombolytic therapy and 30 patients underwent surgery. The difference between pre-intervention and third-day post-intervention in terms of RVD and SPAP was significantly greater in patients under surgical embolectomy (P < 0.001). There was a significant decline in RVD and SPAP in both groups during follow-up (P < 0.001). Mortality rate in the surgical embolectomy group was lower than the thrombolytic group although not significantly. |
2 |
| 19. Chopard R, Nielsen P, Ius F, et al. Optimal reperfusion strategy in acute high-risk pulmonary embolism requiring extracorporeal membrane oxygenation support: a systematic review and meta-analysis. European Respiratory Journal. 60(5), 2022 11. |
Meta-analysis |
17 studies (327 PE patients) |
To conduct a systematic review and meta-analysis of evidence comparing mechanical embolectomy and other strategies, including systemic thrombolysis, catheter-directed thrombolysis or ECMO as stand-alone therapy, with regard to mortality and bleeding outcomes. |
We identified 835 studies, 17 of which were included, comprising 327 PE patients. Overall, 32.4% were treated with mechanical pulmonary reperfusion (of whom 85.9% had surgical embolectomy), while 67.6% received other strategies. The mortality rate was 22.6% in the mechanical reperfusion group and 42.8% in the "other strategies" group. The pooled odds ratio for mortality with mechanical reperfusion was 0.439 (95% CI 0.237-0.816) (p=0.009; I2=35.2%) versus other reperfusion strategies and 0.368 (95% CI 0.185-0.733) (p=0.004; I2=32.9%) for surgical embolectomy versus thrombolysis. The rate of bleeding in patients under ECMO was 22.2% in the mechanical reperfusion group and 19.1% in the "other strategies" group (OR 1.27, 95% CI 0.54-2.96; I2=7.7%). The meta-regression model did not identify any relationship between the covariates "more than one pulmonary reperfusion therapy", "ECMO implantation before pulmonary reperfusion therapy", "clinical presentation of PE" or "cancer-associated PE" and the associated outcomes. |
Good |
| 20. Percy ED, Shah R, Hirji S, et al. National Outcomes of Surgical Embolectomy for Acute Pulmonary Embolism. Annals of Thoracic Surgery. 110(2):441-447, 2020 08. |
Observational-Tx |
58,974 patients with acute pulmonary embolism |
To examine contemporary outcomes of patients treated for acute pulmonary embolism on a nationwide scale. |
The study included 58,974 patients with acute pulmonary embolism; of these, 33,553 were treated with systemic thrombolysis, 22,336 with catheter-directed therapy, and 3085 underwent surgical embolectomy. Thrombolysis was the most common, with a substantial increase after 2012, while surgical volumes remained stable. Patients in the surgical group, compared with systemic thrombolysis and catheter-directed therapy, had more saddle emboli (22% vs 10% vs 10%) and were more frequently at severe risk of death (56% vs 42% vs 26%; both P < .01). Surgical embolectomy patients had higher in-hospital mortality (20% vs 16% vs 7%), stroke (7% vs 6% vs 3%), and blood transfusion (32% vs 16% vs 10%; all P < .01). Rates of major bleeding and intracranial hemorrhage were highest in the systemic thrombolysis group. Among surgical patients, age older than 60 years, atrial fibrillation and nonsaddle embolus were associated with increased odds of mortality. |
2 |
| 21. Marti C, John G, Konstantinides S, et al. Systemic thrombolytic therapy for acute pulmonary embolism: a systematic review and meta-analysis. [Review]. Eur Heart J. 36(10):605-14, 2015 Mar 07. |
Meta-analysis |
15 trials involving 2057 patients |
To review the risks and benefits of thrombolytic therapy in the management of patients with acute PE. |
We systematically reviewed randomized controlled studies comparing systemic thrombolytic therapy plus anticoagulation with anticoagulation alone in patients with acute PE. Fifteen trials involving 2057 patients were included in our meta-analysis. Compared with heparin, thrombolytic therapy was associated with a significant reduction of overall mortality (OR; 0.59, 95% CI: 0.36-0.96). This reduction was not statistically significant after exclusion of studies including high-risk PE (OR; 0.64, 95% CI: 0.35-1.17). Thrombolytic therapy was associated with a significant reduction in the combined endpoint of death or treatment escalation (OR: 0.34, 95% CI: 0.22-0.53), PE-related mortality (OR: 0.29; 95% CI: 0.14-0.60) and PE recurrence (OR: 0.50; 95% CI: 0.27-0.94). Major haemorrhage (OR; 2.91, 95% CI: 1.95-4.36) and fatal or intracranial bleeding (OR: 3.18, 95% CI: 1.25-8.11) were significantly more frequent among patients receiving thrombolysis. |
Not Assessed |
| 22. Wang TF, Squizzato A, Dentali F, Ageno W. The role of thrombolytic therapy in pulmonary embolism. Blood 2015;125:2191-9. |
Review/Other-Tx |
N/A |
To provide evidence-based practice recommendations for the use of thrombolytic therapies in the treatment of PE with and without hemodynamic instability. |
No abstract available |
4 |
| 23. Kucher N, Boekstegers P, Muller OJ, et al. Randomized, controlled trial of ultrasound-assisted catheter-directed thrombolysis for acute intermediate-risk pulmonary embolism. Circulation. 129(4):479-86, 2014 Jan 28. |
Observational-Tx |
59 patients with acute main or lower lobe pulmonary embolism |
To investigate whether ultrasound-assisted catheter-directed thrombolysis (USAT) is superior to anticoagulation alone in the reversal of RV dilatation in intermediate-risk patients. |
Fifty-nine patients (63±14 years) with acute main or lower lobe pulmonary embolism and echocardiographic RV to left ventricular dimension (RV/LV) ratio =1.0 were randomized to receive unfractionated heparin and an USAT regimen of 10 to 20 mg recombinant tissue plasminogen activator over 15 hours (n=30; USAT group) or unfractionated heparin alone (n=29; heparin group). Primary outcome was the difference in the RV/LV ratio from baseline to 24 hours. Safety outcomes included death, major and minor bleeding, and recurrent venous thromboembolism at 90 days. In the USAT group, the mean RV/LV ratio was reduced from 1.28±0.19 at baseline to 0.99±0.17 at 24 hours (P<0.001); in the heparin group, mean RV/LV ratios were 1.20±0.14 and 1.17±0.20, respectively (P=0.31). The mean decrease in RV/LV ratio from baseline to 24 hours was 0.30±0.20 versus 0.03±0.16 (P<0.001), respectively. At 90 days, there was 1 death (in the heparin group), no major bleeding, 4 minor bleeding episodes (3 in the USAT group and 1 in the heparin group; P=0.61), and no recurrent venous thromboembolism. |
1 |
| 24. Tapson VF, Sterling K, Jones N, et al. A Randomized Trial of the Optimum Duration of Acoustic Pulse Thrombolysis Procedure in Acute Intermediate-Risk Pulmonary Embolism: The OPTALYSE PE Trial. JACC Cardiovasc Interv. 11(14):1401-1410, 2018 07 23. |
Observational-Tx |
101 patients |
To determine the lowest optimal tissue plasminogen activator (tPA) dose and delivery duration using ultrasound-facilitated catheter-directed thrombolysis (USCDT) for the treatment of acute intermediate-risk (submassive) pulmonary embolism. |
One hundred one patients were randomized, and improvements in right ventricular-to-left ventricular diameter ratio were as follows: arm 1 (4 mg/lung/2 h), 0.40 (24%; p = 0.0001); arm 2 (4 mg/lung/4 h), 0.35 (22.6%; p = 0.0001); arm 3 (6 mg/lung/6 h), 0.42 (26.3%; p = 0.0001); and arm 4 (12 mg/lung/6 h), 0.48 (25.5%; p = 0.0001). Improvement in refined modified Miller score was also seen in all groups. Four patients experienced major bleeding (4%). Of 2 intracranial hemorrhage events, 1 was attributed to tPA delivered by USCDT. |
1 |
| 25. Avgerinos ED, Jaber W, Lacomis J, et al. Randomized Trial Comparing Standard Versus Ultrasound-Assisted Thrombolysis for Submassive Pulmonary Embolism: The SUNSET sPE Trial. Jacc: Cardiovascular Interventions. 14(12):1364-1373, 2021 06 28. |
Observational-Tx |
40 patients (Intervention Arm - USAT); 41 patients (Control Arm - SCDT) |
To determine whether ultrasound-assisted thrombolysis (USAT) is superior to standard catheter-directed thrombolysis (SCDT) in pulmonary arterial thrombus reduction for patients with submassive pulmonary embolism (sPE). |
Eighty-one patients with acute sPE were randomized and were available for analysis. The mean total dose of alteplase for USAT was 19 ± 7 mg and for SCDT was 18 ± 7 mg (P = 0.53), infused over 14 ± 6 and 14 ± 5 hours, respectively (P = 0.99). In the USAT group, the mean raw pulmonary arterial thrombus score was reduced from 31 ± 4 at baseline to 22 ± 7 (P < 0.001). In the SCDT group, the score was reduced from 33 ± 4 to 23 ± 7 (P < 0.001). There was no significant difference in mean thrombus score reduction between the 2 groups (P = 0.76). The mean reduction in right ventricular/left ventricular ratio from baseline (1.54 ± 0.30 for USAT, 1.69 ± 0.44 for SCDT) to 48 hours was 0.37 ± 0.34 in the USAT group and 0.59 ± 0.42 in the SCDT group (P = 0.01). Major bleeding (1 stroke and 1 vaginal bleed requiring transfusion) occurred in 2 patients, both in the USAT group. |
1 |
| 26. Tu T, Toma C, Tapson VF, et al. A Prospective, Single-Arm, Multicenter Trial of Catheter-Directed Mechanical Thrombectomy for Intermediate-Risk Acute Pulmonary Embolism: The FLARE Study. JACC Cardiovasc Interv. 12(9):859-869, 2019 05 13. |
Observational-Tx |
106 patients |
To evaluate the safety and effectiveness of percutaneous mechanical thrombectomy using the FlowTriever System (Inari Medical, Irvine, California) in a prospective trial of patients with acute intermediate-risk pulmonary embolism (PE). |
From April 2016 to October 2017, 106 patients were treated with the FlowTriever System at 18 U.S. sites. Two patients (1.9%) received adjunctive thrombolytics and were analyzed separately. Mean procedural time was 94 min; mean intensive care unit stay was 1.5 days. Forty-three patients (41.3%) did not require any intensive care unit stay. At 48 h post-procedure, average RV/LV ratio reduction was 0.38 (25.1%; p < 0.0001). Four patients (3.8%) experienced 6 major adverse events, with 1 patient (1.0%) experiencing major bleeding. One patient (1.0%) died, of undiagnosed breast cancer, through 30-day follow-up. |
2 |
| 27. Sista AK, Horowitz JM, Tapson VF, et al. Indigo Aspiration System for Treatment of Pulmonary Embolism: Results of the EXTRACT-PE Trial. JACC Cardiovasc Interv. 14(3):319-329, 2021 02 08. |
Observational-Tx |
119 patients with symptoms of acute submassive PE |
To prospectively evaluate the safety and efficacy of the Indigo aspiration system in submassive acute pulmonary embolism (PE). |
A total of 119 patients (mean age 59.8 ± 15.0 years) were enrolled at 22 U.S. sites between November 2017 and March 2019. Median device insertion to removal time was 37.0 (interquartile range: 23.5 to 60.0) min. Two (1.7%) patients received intraprocedural thrombolytics. Mean RV/LV ratio reduction from baseline to 48 h post-procedure was 0.43 (95% confidence interval: 0.38 to 0.47; p < 0.0001). Two (1.7%) patients experienced 3 major adverse events. Rates of cardiac injury, pulmonary vascular injury, clinical deterioration, major bleeding, and device-related death at 48 h were 0%, 1.7%, 1.7%, 1.7%, and 0.8%, respectively. |
2 |
| 28. Semaan DB, Phillips AR, Reitz K, et al. Improved long-term outcomes with catheter-directed therapies over medical management in patients with submassive pulmonary embolism-a retrospective matched cohort study. J Vasc Surg Venous Lymphat Disord. 11(1):70-81, 2023 01. |
Observational-Tx |
235 patients (anticoagulation alone) and 235 patients (CDT with anticoagulation) |
To determine the short- and long-term mortality and outcomes of CDT compared with anticoagulation for patients with sPE. |
Of 6746 sPE hospitalizations, the patients who had received CDT were younger (age, 58.9 ± 15.5 years vs 61.5 ± 17.4 years; P = .004), were more frequently White (92.5% vs 85.7%; P < .001), and had presented with a higher mean heart rate (104.6 bpm vs 94.9 bpm; P < .001), lower median systolic blood pressure (129 mm Hg vs 135 mm Hg; P < .001), and a greater incidence of right heart strain (79.2% vs 20.3%; P < .001). A total of 470 patients were matched, with 235 in the CDT group and 235 in the anticoagulation-only group. CDT was associated with a lower risk of mortality compared with anticoagulation at 1 year (7.6% vs 9.8%; mHR, 0.77; 95% CI, 0.65-0.92; P = .004), 3 years (11.1% vs 16.6%; mHR, 0.64; 95% CI, 0.55-0.73; P < .001), and 5 years (14.5% vs 19.1%; mHR, 0.71; 95% CI, 0.66-0.77; P < .001). Anticoagulation alone resulted in a greater incidence of PE-related deaths at 1, 3, and 5 years. The mortality at 30 days and 3 months was similar; however, CDT had resulted in better survival at 6 months (mHR, 0.81; 95% CI, 0.68-0.97; P = .02). No differences were found between the two groups in the incidence of bleeding complications at 30 days, development of chronic thromboembolic pulmonary hypertension, or the mean walking distance at 1 year. |
2 |
| 29. Neely RC, Byrne JG, Gosev I, et al. Surgical Embolectomy for Acute Massive and Submassive Pulmonary Embolism in a Series of 115 Patients. Annals of Thoracic Surgery. 100(4):1245-51; discussion 1251-2, 2015 Oct. |
Observational-Tx |
115 patients who underwent surgical pulmonary embolectomy (49 masstive PE patients and 56 submassive PE patients) |
To present one of the largest series to date of pulmonary embolectomy for acute, central PE, with and without hemodynamic compromise, to share our improved outcomes and emphasize the need for broader indications for surgical pulmonary embolectomy for acute PE. |
Mean age was 59 ± 13 years; 46 of 105 patients (44%) had recent surgery (within 5 weeks): orthopedic (12 of 46, 25%), neurosurgery (11 of 46, 24%), or general surgery (10 of 46, 22%). Preoperative demographics did not differ between groups, except for the frequency of cardiopulmonary resuscitation among unstable patients (11 of 49, 22%) versus stable patients (0 of 56, 0%; p < 0.001). Operative mortality for the combined groups was 6.6% (7 of 105): unstable 10.2% (5 of 49) versus stable 3.6% (2 of 56; p = 0.247). Of 11 patients requiring preoperative cardiopulmonary resuscitation, 4 died. Six-month, 1-year, and 3-year survival rates were, respectively, 75%, 68.4%, and 65.8% for unstable PE, and 92.6%, 86.7%, and 80.4% for stable PE (p = 0.018). |
3 |
| 30. Kolkailah AA, Hirji S, Piazza G, et al. Surgical pulmonary embolectomy and catheter-directed thrombolysis for treatment of submassive pulmonary embolism. J Card Surg. 33(5):252-259, 2018 May. |
Observational-Tx |
133 submassive PE patients (62 in catheter-directed thrombolysis and 71 in pulmonary embolectomy) |
To report the results for patients who did not qualify for medical therapy and required treatment of submassive PE with surgical pulmonary embolectomy and catheter directed thrombolysis (CDT) |
The mean age of submassive PE patients was 57.3 years, which included 36.8% females. PE risk factors included previous deep venous thrombosis (46.6%), immobility (36.1%), recent surgery (30.8%), and cancer (22.6%), P < 0.05. The most common indication for advanced treatment was right ventricular strain (42.9%), P = 0.03. The frequency of surgical pulmonary embolectomy remained stable even after incorporating the EKOS procedure into our treatment algorithm, with statistically similar operative mortality. Bleeding was observed in six CDT patients and one pulmonary embolectomy patient (P < 0.05). Follow-up echocardiography was available for 61% of the overall cohort, of whom 76.5% had no residual moderate or severe right ventricular dysfunction. |
2 |
| 31. Meyer G, Vicaut E, Danays T, et al. Fibrinolysis for patients with intermediate-risk pulmonary embolism. N Engl J Med. 370(15):1402-11, 2014 Apr 10. |
Observational-Tx |
Tenecteplase group (n = 506 patients) and Placebo group (n = 499 patients) |
To investigate the clinical efficacy and safety of fibrinolytic therapy with a single-bolus injection of tenecteplase, in addition to standard anticoagulation therapy with heparin, in normotensive patients with acute pulmonary embolism and an intermediate risk of an adverse outcome. |
Of 1006 patients who underwent randomization, 1005 were included in the intention-to-treat analysis. Death or hemodynamic decompensation occurred in 13 of 506 patients (2.6%) in the tenecteplase group as compared with 28 of 499 (5.6%) in the placebo group (odds ratio, 0.44; 95% confidence interval, 0.23 to 0.87; P=0.02). Between randomization and day 7, a total of 6 patients (1.2%) in the tenecteplase group and 9 (1.8%) in the placebo group died (P=0.42). Extracranial bleeding occurred in 32 patients (6.3%) in the tenecteplase group and 6 patients (1.2%) in the placebo group (P<0.001). Stroke occurred in 12 patients (2.4%) in the tenecteplase group and was hemorrhagic in 10 patients; 1 patient (0.2%) in the placebo group had a stroke, which was hemorrhagic (P=0.003). By day 30, a total of 12 patients (2.4%) in the tenecteplase group and 16 patients (3.2%) in the placebo group had died (P=0.42). |
1 |
| 32. Konstantinides SV, Vicaut E, Danays T, et al. Impact of Thrombolytic Therapy on the Long-Term Outcome of Intermediate-Risk Pulmonary Embolism. Journal of the American College of Cardiology. 69(12):1536-1544, 2017 Mar 28. |
Observational-Tx |
Tenecteplase group (n = 359) and Placebo group (n = 350) |
To investigate the long-term prognosis of patients with intermediate-risk PE and the effect of thrombolytic treatment on the persistence of symptoms or the development of late complications. |
Long-term (median 37.8 months) survival was assessed in 353 of 359 (98.3%) patients in the thrombolysis arm and in 343 of 350 (98.0%) in the placebo arm. Overall mortality rates were 20.3% and 18.0%, respectively (p = 0.43). Between day 30 and long-term follow-up, 65 deaths occurred in the thrombolysis arm and 53 occurred in the placebo arm. At follow-up examination of survivors, persistent dyspnea (mostly mild) or functional limitation was reported by 36.0% versus 30.1% of the patients (p = 0.23). Echocardiography (performed in 144 and 146 patients randomized to thrombolysis and placebo, respectively) did not reveal significant differences in residual pulmonary hypertension or RV dysfunction. Chronic thromboembolic pulmonary hypertension (CTEPH) was confirmed in 4 (2.1%) versus 6 (3.2%) cases (p = 0.79). |
1 |
| 33. Bariteau A, Stewart LK, Emmett TW, Kline JA. Systematic Review and Meta-analysis of Outcomes of Patients With Subsegmental Pulmonary Embolism With and Without Anticoagulation Treatment. Academic Emergency Medicine. 25(7):828-835, 2018 07. |
Meta-analysis |
14 studies (15,563 patients) |
To report the frequency of death, bleeding, and recurrent venous thromboembolism (VTE) inpatients with SSPE based on the decision to treat ornot treat with systemic anticoagulation. |
From 1,512 papers screened, we included 14 studies comprising 15,563 patients for full-length review and analysis. Pooled data demonstrated I2 = 99% with an Eggers p < 0.001, suggesting significant publication bias. The pooled prevalence of SSPE was 4.6% (95% confidence interval [CI] = 1.8%-8.5%). The frequency of bleeding in SSPE patients treated with anticoagulation (n = 589) was 8.1% (95% CI = 2.8%-15.8%), with no available bleeding data in untreated patients (n = 126). The frequency of VTE recurrence within 90 days was 5.3% (95% CI = 1.6%-10.9%) for treated versus 3.9% (95% CI = 4.8%-13.4%) for untreated, while the frequency of death was 2.1% (95% CI = 3.4%-5.2%) for treated versus 3.0% (95% CI = 2.8%-8.6%) for untreated. |
Not Assessed |
| 34. Greelish JP, Leacche M, Solenkova NS, Ahmad RM, Byrne JG. Improved midterm outcomes for type A (central) pulmonary emboli treated surgically. J Thorac Cardiovasc Surg. 142(6):1423-9, 2011 Dec. |
Observational-Tx |
103 patients with type A pulmonary emboli |
To propose a simplified anatomic classification for pulmonary emboli that algorithmically differentiates those who might be best treated with surgical pulmonary embolectomy (type A) from those best treated medically (type B).To hypothesize that patients with type A pulmonary emboli treated with immediate surgical embolectomy demonstrate superior long-term survival compared with patients with type A pulmonary emboli treated medically. |
Of the 103 patients with type A pulmonary emboli, 15 (14%) were treated with immediate surgical pulmonary embolectomy, and 88 (85%) were treated medically. Patients with type A pulmonary emboli treated surgically had similar 30-day mortality compared with those treated medically (13% vs 17%, P = .532). At a mean of 24 ± 18 months' follow-up (range, 1-82 months), survival at 1, 3, and 5 years for patients with type A pulmonary emboli treated surgically was significantly better than that in the patients with type A pulmonary emboli treated medically (P = .0001). |
2 |
| 35. Jain CC, Chang Y, Kabrhel C, et al. Impact of Pulmonary Arterial Clot Location on Pulmonary Embolism Treatment and Outcomes (90 Days). Am J Cardiol. 119(5):802-807, 2017 03 01. |
Observational-Tx |
269 patients with submassive and massive PE |
To examine the associations of clot location, practice patterns, and outcomes in patients with submassive and massive PE. |
Among 269 patients, there were no significant demographic differences between patients with peripheral and central PE. Peripheral PE was more likely to present with hypotension (46.4% vs 32.6%; p = 0.02), but central PE was more likely to have RV strain on echocardiography (76.7% vs 57.7%, p <0.001) and computed tomography (58.1% vs 32.0%, p <0.0001). Peripheral PE was more likely to receive anticoagulation as the only form of therapy (69.1% vs 55.8%; p = 0.03), and central PE was more likely to receive catheter-directed therapies (18.3% vs 3.3%; p <0.001). Nonetheless, peripheral PE had higher 30- and 90-day all-cause mortality (18.5% vs 9.3%; p = 0.03; 25.9% vs 13.5%; p = 0.02, respectively). In a multivariable analysis, the only independent predictor of death or RV strain at 90 days was increased age (odds radio 1.35, CI 1.06 to 1.72 per 10 years). |
2 |
| 36. Senturk A, Ozsu S, Duru S, et al. Prognostic importance of central thrombus in hemodynamically stable patients with pulmonary embolism. Cardiol J. 24(5):508-514, 2017. |
Observational-Tx |
874 patients with normotensive acute PE |
To investigate whether central thrombus in the pulmonary artery affects 30-day mortality rate, and to compare the outcomes of different treatment approaches in patients with central thrombus. |
Localization of the emboli was central in 319 (36.5%) patients, lobar in 264 (30.2%) and distal in 291 (33.2%) patients. Seventy-four (8.5%) patients died during the 30-day follow-up period. All-cause mortality rate was 11.9%, 6.8% and 6.2% in patients with central, lobar, and distal emboli, respectively (p < 0.001). Multivariate analysis did not show that hemodynamically stable central thrombus was an independent predictor of mortality. Additionally, mortality rate was not significantly different between UFH, LMWH and thrombolytic therapy groups. |
2 |
| 37. Isath A, Shah R, Bandyopadhyay D, et al. Dispelling the Saddle Pulmonary Embolism Myth (from a Comparison of Saddle Versus Non-Saddle Pulmonary Embolism). American Journal of Cardiology. 201:341-348, 2023 08 15. |
Observational-Tx |
174 patients with PE (92 with saddle PE and 82 with non-saddle PE) |
To determine the magnitude of SPE proximal pulmonary artery (PA) flow obstruction and its impact on right ventricular (RV) function in the setting of acute PE in a single-center series. |
A total of 174 patients were identified (SPE 92 [52.9%] and non-SPE 82 [47.1%]). Demographics and co-morbidities were similar. In patients with SPE, there was a mean 25.9% total flow obstruction (right PA 26.9% and left PA 25.5%). Non-SPE had greater clinical RV dysfunction on presentation as reflected by more high-risk PE (43.9% vs 26.1%, p = 0.01), need for venoarterial extracorporeal membrane oxygenation (21.9% vs 10.9%, p = 0.05), and more preoperative cardiopulmonary resuscitation (16.7% vs 7.8%, p = 0.08). RV:left ventricular ratio (CT and transthoracic echocardiography) and RV fractional area change were statistically similar between groups. In-hospital mortality was statistically similar between cohorts (4.9% non-SPE vs 2.1% SPE, p = 0.32). |
3 |
| 38. Ata F, Ibrahim WH, Choudry H, et al. Optimal management, prevalence, and clinical behavior of saddle pulmonary embolism: A systematic review and meta-analysis. [Review]. Thrombosis Research. 217:86-95, 2022 09. |
Meta-analysis |
194 studies (5251 patients) |
To pool the available data on the clinical behavior and outcomes of SPE and study the effects of various treatment modalities on mortality outcomes. |
Results from all SPE cases: A total of 5251 patients from 194 studies were included in the review. Dyspnea (57 %) was the most prevalent symptom. Massive and submassive PE comprised 9.7 % and 45.8% of cases, respectively. Thrombolytic therapy (TT) was administered in 18.1 %, and thrombectomy was performed in 16 % of cases. SPE-related mortality was observed in 4.6 %, late decompensation in 9.5 %, and PE recurrence in 4.5 % of cases. Female sex (61.5 % vs. 41.3 %, p = 0.019), hypoxemia (90 % vs. 59.2 %, p < 0.001), massive PE features (89.7 % vs. 30.1 %, p < 0.001), associated chronic kidney disease (CKD) (10.3 % vs. 1.4 %, p = 0.002), and the need for mechanical ventilation (28.2 % vs. 13.1 %, p = 0.02) were significantly associated with increased mortality. The use of TT was significantly associated with increased survival (27.1 % vs. 12.5 %, p < 0.001). In a multivariate logistic regression model, massive PE features significantly increased the odds of death (OR: 29.3, CI: 4.86-181.81, p < 0.001), whereas, treatment with anticoagulation (AC) alone (OR: 0.1, CI: 0.027-0.356, p < 0.001), TT (OR: 0.065, CI: 0.019-0.26, p < 0.001), surgical thrombectomy (ST) (OR: 0.047, CI: (0.010-0.23), p < 0.001), or percutaneous thrombectomy (PT) (OR: 0.12, CI: 0.020-0.84, p = 0.032) significantly decreased odds of death. Results from a meta-analysis of observational studies: Meta-analysis of the included 17 observational studies revealed an overall 10 % (95 % CI: 4.56-16.89) SPE prevalence among all PE cases. The overall SPE-related mortality rate was 8 % (95 % CI: 5.26-10.96). Massive PE was observed in 13.3 % (95 % CI: 5.56-23.70), PE recurrence in 5.1 % (95 % CI: 2.22-9.05), and late decompensation in 11 % (95 % CI: 3.43-22.34) of patients. |
Good |
| 39. Chatterjee S, Weinberg I, Yeh RW, et al. Risk factors for intracranial haemorrhage in patients with pulmonary embolism treated with thrombolytic therapy Development of the PE-CH Score. Thrombosis & Haemostasis. 117(2):246-251, 2017 01 26. |
Observational-Tx |
9703 patients who received thrombolytics for PE |
To identify risk factors for ICH in PE patients treated with thrombolysis.To develop a risk score including independent predictors of ICH and test the the validity of the risk among a separate cohort of patients identified in the NIS. |
During 2003-2012, 176/9705 (1.8 %) patients with PE experienced ICH after thrombolytic use. Four independent prognostic factors were identified in a backward logistic regression model, and each was assigned a number of points proportional to its regression coefficient: pre-existing Peripheral vascular disease (1 point), age greater than 65 years (Elderly) (1 point), prior Cerebrovascular accident with residual deficit (5 points), and prior myocardial infarction (Heart attack) (1 point). In the derivation cohort, scores of 0, 1, 2 and = 5 points were associated with ICH risks of 1.2 %, 1.9 %, 2.4 % and 17.8 %, respectively. Rates of ICH were similar in the validation cohort. The C-statistic for the risk score was 0.65 (0.61-0.70) in the derivation cohort and 0.66 (0.60-0.72) in the validation cohort. |
2 |
| 40. Oneglia C, Gualeni A. Pulmonary embolism after brain hemorrhage in a hypertensive patient: the therapeutic dilemma. J Thromb Thrombolysis 2008;25:231-4. |
Review/Other-Tx |
1 case |
To report the case of a 46-year-old patient with uncontrolled systemic hypertension who was affected by severe spontaneous cerebral hemorrhage and left hemiparesis. |
After some days of rehabilitation care he developed sudden dyspnea, tachycardia and hypotension secondary to bilateral pulmonary embolism. Owing to controindication to the use of thrombolytic agents, anticoagulant therapy with high-dose intravenous unfractionated heparin followed by oral warfarin was begun, with a successful and uncomplicated outcome. The therapeutic approach to similar not uncommon cases is debated and some hypotheses are made about the aetiology of pulmonary embolism in these patients. |
4 |
| 41. Lee WC, Fang HY. Management of pulmonary embolism after recent intracranial hemorrhage: A case report. Medicine (Baltimore) 2018;97:e0479. |
Review/Other-Tx |
1 case |
To review a 57-year-old man experienced massive pulmonary embolism and shock 18 days after an intracerebral hemorrhage. |
Heparinization were used and activated partial thromboplastin time therapeutic range was 50 to 70 seconds. Fortunately, shock status and shortness of breath improved two days later. Continuing high dose Rivaroxaban was administrated for three weeks. |
4 |
| 42. Meng Y, Zhang J, Ma Q, et al. Pulmonary Interventional Therapy for Acute Massive and Submassive Pulmonary Embolism in Cases Where Thrombolysis Is Contraindicated. Annals of Vascular Surgery. 64:169-174, 2020 Apr. |
Observational-Tx |
97 patients who received pharmacomechanical therapy |
To analyze the clinical outcomes of pharmacomechanical therapy for massive and submassive acute pulmonary embolism (APE). |
Of the 97 patients, 46 (47%) were men, and the mean age of the patients was 56 ± 14 years (median, 58 years; range, 21-84 years). Fifty patients had massive PE, whereas the remaining had submassive PE. Analysis of the site of embolus revealed that 67 (69%) had bilateral emboli in the pulmonary arteries (PAs); 5 (5%) only in the left PA, and 25 (26%) only in the right PA. Seventy-nine (81%) of the 97 patients underwent intraoperative placement of the inferior vena caval filters, whereas 3 (3%) required use of a noninvasive ventilator. Two (2%) patients died within 30 days of the interventional therapy because of severe right ventricular failure. The amount of blood loss was nonsignificant. |
2 |
| 43. Lee KA, Cha A, Kumar MH, Rezayat C, Sales CM. Catheter-directed, ultrasound-assisted thrombolysis is a safe and effective treatment for pulmonary embolism, even in high-risk patients. J Vasc Surg Venous Lymphat Disord. 5(2):165-170, 2017 03. |
Observational-Tx |
91 patients who had a CT diagnosis of acute PE and pulmonary hypertension (PAP >25 mm Hg) |
To assess the early success and safety of catheter-directed, ultrasound-assisted (CDUA) thrombolysis for acute pulmonary embolism (PE) in patients deemed to be "high risk" for thrombolytic therapy. |
Seventeen patients (19%) were deemed to be at high risk for bleeding, predicted by recent hemorrhage, major surgery within 3 weeks, acute myocardial infarction, and cardiac arrest with cardiopulmonary resuscitation within 1 week. The high-risk patients in our study were noted to have higher RV:LV ratios and lower oxygen saturations on admission (P < .05). On computed tomography angiography, the mean pretherapy RVaxial:LVaxial ratio was 1.5 ± 0.4. The mean pretherapy PAP was 56.2 ± 15.2 mm Hg. After 18.5 ± 3.5 hours of thrombolysis, the mean post-therapy PAP was 34.3 ± 10.4 mm Hg, with a pressure drop of 21.9 ± 4.8 mm Hg (39% decrease; P < .001). In total, seven patients (8%) suffered bleeding complications that required intervention-four gastrointestinal bleeds, a rectus sheath hematoma, and one gross hematuria. Three of the seven complications occurred in the high-risk group (3/17) and the other four in the general population of patients (4/74; P = .118). Minor bleeding complications (n = 14 [15%]) did not require intervention and included puncture site hematomas, ecchymosis, and mild traumatic hematuria. Considering all bleeding complications, increasing RVaxial:LVaxial ratio was a predictor of any bleeding complication, independent of all risk factors (P = .005). |
3 |
| 44. Gangaraju R, Klok FA. Advanced therapies and extracorporeal membrane oxygenation for the management of high-risk pulmonary embolism. Hematology Am Soc Hematol Educ Program 2020;2020:195-200. |
Review/Other-Tx |
1 case |
To discuss the management of high-risk PE when systemic thrombolysis is contraindicated due to a high risk of major bleeding, with an emphasis on the role for ECMO. |
No results stated in abstract. |
4 |
| 45. Musleh R, Schlattmann P, Caldonazo T, et al. Surgical Timing in Patients With Infective Endocarditis and With Intracranial Hemorrhage: A Systematic Review and Meta-Analysis. J Am Heart Assoc 2022;11:e024401. |
Meta-analysis |
9 studies |
To evaluate the impact of early surgery in patients with IE and with ICH on postoperative neurological deterioration and all-cause mortality and to elucidate the risk of 30-day mortality in patients who were denied surgery. |
Three libraries (MEDLINE, EMBASE, and Cochrane Library) were assessed. The primary outcome was all- cause mortality, and the secondary outcome was neurological deterioration. Inverse variance method and random model were performed. We identified 16 studies including 355 patients. Nine studies examined the impact of surgical timing (early versus late) and were included in the meta- analysis. Only one study examined the fate of patients with IE and with ICH who were treated conservatively despite having an indication for cardiac surgery, showing higher mortality rates than those who underwent surgery (11.8% versus 2.5%). We found no significant association between early surgery, regardless of its definition, and a higher mortality (odds ratio [OR], 1.69; 95% CI, 0.95– 3.02). Early surgery was associated with higher risk for neurological deterioration (OR, 2.00; 95% CI, 1.10– 3.65). |
Inadequate |
| 46. Koc M, Kostrubiec M, Elikowski W, et al. Outcome of patients with right heart thrombi: the Right Heart Thrombi European Registry. Eur Respir J. 47(3):869-75, 2016 Mar. |
Observational-Tx |
138 patients with RiHT and 276 patients without RiHT |
To assess the prognostic significance of right heart thrombi (RiHT) and their characteristics in pulmonary embolism in relation to established prognostic factors. |
In RiHT patients, pulmonary embolism mortality was higher in 31 patients with systolic blood pressure <90 mmHg than in 107 normotensives (42% versus 12%, p=0.0002) and was higher in the 83 normotensives with right ventricular dysfunction (RVD) than in the 24 normotensives without RVD (16% versus 0%, p=0.038). In multivariable analysis the simplified Pulmonary Embolism Severity Index predicted mortality (hazard ratio 2.43, 95% CI 1.58-3.73; p<0.0001), while RiHT characteristics did not. Patients with RiHT had higher pulmonary embolism mortality than controls (19% versus 8%, p=0.003), especially normotensive patients with RVD (16% versus 7%, p=0.02).30-day mortality in patients with RiHT is related to haemodynamic consequences of pulmonary embolism and not to RiHT characteristics. |
2 |
| 47. Barrios D, Chavant J, Jimenez D, et al. Treatment of Right Heart Thrombi Associated with Acute Pulmonary Embolism. Am J Med. 130(5):588-595, 2017 May. |
Observational-Tx |
325 patients with pulmonary embolism |
To compare outcomes during the first month after treatment for an acute symptomatic pulmonary embolism in patients who had coexisting right heart thrombi for those who receive reperfusion treatment (ie, thrombolysis, surgery) with a propensity-matched cohort of those who did not. |
Of 325 patients with pulmonary embolism and right heart thrombi, 255 (78%; 95% confidence interval, 74-83) received anticoagulation and 70 (22%; 95% confidence interval, 17-26) also received reperfusion treatment. Propensity score-matched pairs analyses did not detect a statistically lower risk of all-cause death (6.2% vs 14%, P = .15) or pulmonary embolism-related mortality (4.7% vs 7.8%; P = .47) for reperfusion compared with anticoagulation. Of the patients who received reperfusion treatment, 6.2% had a recurrence during the study follow-up period, compared with 0% of those who received anticoagulation (P = .049). The incidence of major bleeding events was not statistically different between the 2 treatment groups (3.1% vs 3.1%; P = 1.00). |
2 |
| 48. Athappan G, Sengodan P, Chacko P, Gandhi S. Comparative efficacy of different modalities for treatment of right heart thrombi in transit: a pooled analysis. Vascular Medicine. 20(2):131-8, 2015 Apr. |
Review/Other-Tx |
328 patients with RHT and pulmonary embolism (PE) |
To compare the efficacy of treatment options for right heart thrombi (RHT) in transit. |
The treatments administered were none in 11 patients (3.4%), anticoagulation (AC) with heparin in 70 patients (21.3%), thrombolytics in 122 patients (37.2%), catheter-related treatments in five patients (1.5%) and surgical embolectomy in 120 patients (36.6%). The overall short-term mortality for the entire cohort was 23.2%. The mortality rate associated with no therapy was highest at 90.9%. The mortality associated with AC alone was significantly higher than surgical embolectomy or thrombolysis (37.1% vs 18.3% vs 13.7%, respectively). In univariate analysis, any therapy was better than no therapy with a favorable odds of 16.92 (95% CI 2.05–139.87) for AC, 61.76 (95% CI 7.42–513.81) for thrombolysis and 44.54 (95% CI 5.42–366.32) for surgical embolectomy. In multivariate analysis with age and hemodynamic status entered as covariates, thrombolytic therapy was better than AC with favorable odds of 4.83 (95% CI 1.52–15.36). Similarly, there was a trend in favor of surgical embolectomy with an odds of 2.61 (95% CI 0.90–7.58). The estimated probability of survival in hemodynamically unstable patients with AC, surgical embolectomy and thrombolysis was 47.7%, 70.45% and 81.5%, respectively. There was no significantly increased risk of complications with thrombolytic therapy. |
4 |
| 49. Burgos LM, Costabel JP, Galizia Brito V, et al. Floating right heart thrombi: A pooled analysis of cases reported over the past 10years. [Review]. American Journal of Emergency Medicine. 36(6):911-915, 2018 Jun. |
Review/Other-Tx |
207 patients |
To compare the clinical characteristics according to different treatment strategies and to identify predictors of mortality on patients with floating right heart thrombi (FRHTS) . |
207 patients were analyzed, median age was 60years, 51.7% were men, 31.4% presented with shock. Pulmonary thromboembolism was present in 85% of the cases. The treatments administered were anticoagulation therapy in 44 patients (21.28%), surgical embolectomy in 89 patients (43%), thrombolytic therapy in 66 patients (31.8%), percutaneous thrombectomy in 3 patients (1.93%) and fibrinolytic in situ in 4 (1.45%). The overall mortality rate was 21.3%. The mortality associated with anticoagulation alone was higher than surgical embolectomy or thrombolysis (36.4 vs 18% vs 18.2%, respectively, p=0.03), and in percutaneous thrombectomy and fibrinolytics in situ was 0%. At multivariate analysis, only anticoagulation alone (odds ratio [OR] 2.4, IC 95% 1.07-5.4, p=0.03), and shock (OR 2.87 (IC 95% 1.3-5.9, p=0.005) showed a statistically significant effect on mortality. |
4 |
| 50. Islam M, Nesheim D, Acquah S, et al. Right Heart Thrombi: Patient Outcomes by Treatment Modality and Predictors of Mortality: A Pooled Analysis. Journal of Intensive Care Medicine. 34(11-12):930-937, 2019 Nov-Dec. |
Observational-Tx |
316 patients with RiHT and PE |
To evaluate whether patient characteristics and differing treatment modalities predict mortality on our institutional experience in managing right heart thrombi (RiHT). |
We identified 316 patients in our pooled analysis. Patients received the following therapies: no treatment 15 (5%), systemic anticoagulation 73 (23%), systemic thrombolysis 108 (34%), surgical embolectomy 101 (32%), catheter-directed therapy 11 (3%), and systemic thrombolysis with surgery 8 (3%). In-hospital mortality was 18.7%. Univariate analysis showed age and shock reduced odds of survival. Multivariate analysis showed shock reduced odds of survival (odds ratios [OR] 0.36, 95% confidence interval [CI]: 0.19-0.72, P = .01) while age, RV dysfunction, and clot-mobility did not affect mortality. In a reduced multivariate analysis adjusting for shock, treatment modality, and clot location alone, systemic thrombolysis increased odds of survival when compared to systemic anticoagulation (OR 2.72, 95% CI: 1.11-6.64, P = .02). Our institutional series identified 18 patients, where in-hospital mortality was 22.2%, 18 (100%) had RV dysfunction, and 5 (28%) had shock. Patients received the following therapies: systemic anticoagulation 8 (44.4%), systemic thrombolysis 4 (22.2%), surgical embolectomy 4 (22.2%), and catheter-directed thrombolysis 2 (11.1%). |
2 |
| 51. Ibrahim WH, Ata F, Choudry H, et al. Prevalence, Outcome, and Optimal Management of Free-Floating Right Heart Thrombi in the Context of Pulmonary Embolism, a Systematic Review and Meta-Analysis. [Review]. Clinical & Applied Thrombosis/Hemostasis. 28:10760296221140114, 2022 Jan-Dec. |
Review/Other-Tx |
211 publications (397 patients with FFRHT and PE ) |
To perform a systematic review and meta-analysis addressing prevalence, clinical behavior, and outcomes of FFRHT associated with PE. |
Obstructive shock was documented in 48.9% of cases. Treatment with thrombolytic therapy, surgical thrombectomy, and percutaneous thrombectomy was documented in 43.8%, 32.7%, and 6.5% of patients, respectively. The overall mortality rate was 20.4%. Syncope (p: 0.027), chest pain (p: 0.006), and obstructive shock (p: 0.037) were significantly associated with mortality. Use of thrombolytic therapy was significantly associated with survival (p: 0.008). A multivariate logistic regression model to determine mortality predictors revealed that syncope (OR: 1.97, 95% CI: 1.06-3.65, p: 0.03), and obstructive shock (OR: 2.23, 95% CI: 1.20-4.14, p: 0.01) were associated with increased death odds. Treatment with thrombolytic therapy (OR: 0.22, 95% CI: 0.086-0.57, p: 0.002) or surgical thrombectomy (OR: 0.35, 95% CI: 0.137-0.9, p: 0.03) were associated with reduced death odds. Meta-analysis of observational studies revealed a pooled prevalence of FFRHT among all PE cases of 8.1%, and overall mortality of 23%. |
4 |
| 52. Chen G, Zhang X, Wang Q, et al. The removal of floating right heart thrombi and pulmonary embolus using AngioJet device and venoarterial extracorporeal membrane oxygenation: a case report. Ann Transl Med 2022;10:612. |
Review/Other-Tx |
1 case |
To report the case of a patient who presented with hypotension and tachycardia accompanied by an asymptomatic right leg deep vein thrombosis, right atrial thrombus, and pulmonary embolus. |
On arrival in the emergency department, the bedside transthoracic echocardiography (TTE) revealed there was an enlarged right atrium and right ventricle, with a floating right atrial mass prolapsing through the tricuspid valve during diastole. The patient accepted anticoagulation treatment, but refused to undergo thrombolysis or surgical embolectomy. Eventually, the right heart thrombi (RiHT) floated to the left main branch of pulmonary artery. It was successfully treated by using AngioJet device and venoarterial extracorporeal membrane oxygenation (VA-ECMO). |
4 |
| 53. Zielinski D, Zygier M, Dyk W, et al. Acute pulmonary embolism with coexisting right heart thrombi in transit-surgical treatment of 20 consecutive patients. European Journal of Cardio-Thoracic Surgery. 63(4), 2023 04 03. |
Observational-Tx |
20 patients undergoing surgical treatment for acute PE with coexisting RHTiT |
To present the results of surgical treatment of 20 consecutive patients diagnosed with high- or intermediate-high-risk PE with coexisting RHTiT. |
There was no in-hospital death. Nearly one-third of patients required temporal hemofiltration for postoperative renal failure, but this did not involve the need for dialysis at discharge. No neurological complications occurred in any patient. The mean follow-up was 46 months (range 13-98). There was 1 death in the long-term follow-up, not related to PE. |
2 |
| 54. National Academies of Sciences, Engineering, and Medicine; Division of Behavioral and Social Sciences and Education; Committee on National Statistics; Committee on Measuring Sex, Gender Identity, and Sexual Orientation. Measuring Sex, Gender Identity, and Sexual Orientation. In: Becker T, Chin M, Bates N, eds. Measuring Sex, Gender Identity, and Sexual Orientation. Washington (DC): National Academies Press (US) Copyright 2022 by the National Academy of Sciences. All rights reserved.; 2022. |
Review/Other-Dx |
N/A |
Sex and gender are often conflated under the assumptions that they are mutually determined and do not differ from each other; however, the growing visibility of transgender and intersex populations, as well as efforts to improve the measurement of sex and gender across many scientific fields, has demonstrated the need to reconsider how sex, gender, and the relationship between them are conceptualized. |
No abstract available. |
4 |
