Bleeding, death, and costs of care during hospitalization for acute pulmonary embolism: Insights from the Saint Luke’s Outcomes of Pulmonary Embolism (SLOPE) study

2020 ◽  
pp. 1358863X2096741
Author(s):  
Matthew C Bunte ◽  
Kensey Gosch ◽  
Ahmed Elkaryoni ◽  
Anas Noman ◽  
Erin Johnson ◽  
...  

Limited data exist that comprehensively describe the practical management, in-hospital outcomes, healthcare resource utilization, and rates of post-hospital readmission among patients with submassive and massive pulmonary embolism (PE). Consecutive discharges for acute PE were identified from a single health system over 3 years. Records were audited to confirm presence of acute PE, patient characteristics, disease severity, medical treatment, and PE-related invasive therapies. Rates of in-hospital major bleeding and death, hospital length of stay (LOS), direct costs, and hospital readmission are reported. From January 2016 to December 2018, 371 patients were hospitalized for acute massive or submassive PE. In-hospital major bleeding (12.1%) was common, despite low utilization of systemic thrombolysis (1.8%) or catheter-directed thrombolysis (3.0%). In-hospital death was 10-fold higher among massive PE compared to submassive PE (36.6% vs 3.3%, p < 0.001). Massive PE was more common during hospitalizations not primarily related to venous thromboembolism, including hospitalizations primarily for sepsis or infection (26.8% vs 8.2%, p = 0.001). Overall, the median LOS was 6.0 days (IQR, 3.0–11.0) and the median standardized direct cost of admissions was $10,032 (IQR, $4467–$20,330). Rates of all-cause readmission were relatively high throughout late follow-up but did not differ between PE subgroups. Despite low utilization of thrombolysis, in-hospital bleeding remains a common adverse event during hospitalizations for acute PE. Although massive PE is associated with high risk for in-hospital bleeding and death, those successfully discharged after a massive PE demonstrate similar rates of readmission compared to submassive PE into late follow-up.

2021 ◽  
pp. 152660282110547
Author(s):  
Donna Shu-Han Lin ◽  
Yu-Sheng Lin ◽  
Jen-Kuang Lee ◽  
Wen-Jone Chen

Objectives: This study aimed to compare the short-term and long-term follow-up outcomes of catheter-directed thrombolysis (CDT) with those of pulmonary artery embolectomy (PAE) for patients with acute pulmonary embolism (PE) included in a nationwide cohort. Background: Data allowing direct comparisons between CDT and PAE are lacking in the literature, and the optimal management of high-risk and intermediate-risk PE is still debated. Methods: A retrospective cohort study was conducted with data for 2001 through 2013 collected from the Taiwan National Health Insurance Research Database (NHIRD). Patients who were first admitted for PE and treated with either CDT or PAE were included and compared. In-hospital outcomes included in-hospital death and safety (bleeding and cardiac arrhythmias) outcomes. Follow-up outcomes included all-cause mortality and recurrent PE during the 1- and 2-year follow-up periods and through the last follow-up. Inverse probability of treatment weighting (IPTW) based on the propensity score was used to minimize possible selection bias, including indices for multimorbidity such as the Charlson’s Comorbidity Index (CCI) and HAS-BLED scores. Results: A total of 389 patients treated between January 1, 2001, and December 31, 2013, were identified; 169 underwent CDT and 220 underwent PAE. After IPTW, there were no significant differences in in-hospital mortality (18.2% vs 21.3%; odds ratio 1.07, 95% confidence interval [CI]: 0.70–1.62) or the incidence of safety outcomes between the CDT and PAE groups. The risks of all-cause mortality (30% vs 29.5%; hazard ratio 1.16, 95% CI: 0.89–1.53), recurrent PE (7.2% vs 8.7%; subdistribution hazard ratio [SHR] 0.68, 95% CI: 0.39–1.21) and new-onset pulmonary hypertension (SHR 0.25, 95% CI: 0.05–1.32) were also not significantly different between the CDT and PAE groups at 2 years of follow-up. Subgroup analysis indicated that PAE may be associated with a more favorable 2-year mortality in patients <65 years old, patients with CCI scores of <3, patients with HAS-BLED scores of 1 to 2, and patients without cardiogenic shock (all P for interaction <.05). Conclusions: In patients with PE who required reperfusion therapy, CDT and PAE resulted in similar in-hospital and long-term all-cause mortality rates and long-term rates of recurrent PE. Bleeding risks were also comparable in the 2 groups.


Author(s):  
Giacomo Buso ◽  
Lucia Mazzolai ◽  
José Antonio Rueda-Camino ◽  
Carmen Fernández-Capitán ◽  
David Jiménez ◽  
...  

AbstractThe clinical characteristics and outcomes of patients with coronavirus disease 2019 (COVID-19) who develop pulmonary embolism (PE) in the full spectrum of patient care settings need to be elucidated. The aim of this study was to compare the clinical characteristics, treatment, and 90-day outcomes in patients diagnosed with PE while recovering from COVID-19 in the outpatient setting versus those who were diagnosed with PE while being hospitalized with COVID-19. Data from the international Registro Informatizado de Enfermedad TromboEmbólica (RIETE) registry were used. The major study outcomes were all-cause death, major bleeding, and venous thromboembolism (VTE) recurrences during the first 90 days after PE. From March 2020 to March 2021, 737 patients with COVID-19 experienced acute PE. Of these, 340 (46%) were recovering from COVID-19 as outpatients (267 patients who had been treated at home for COVID-19 and 73 discharged after being hospitalized with COVID-19). Compared with inpatients with COVID-19, those recovering in the outpatient setting upon PE were less likely to be men (odds ratio [OR]: 0.54; 95% confidence interval [CI]: 0.40–0.72) and less likely to have hypertension (OR: 0.55; 95% CI: 0.41–0.74) or diabetes (OR: 0.51; 95% CI: 0.33–0.76). At 90-day follow-up, eight patients (none recovering from COVID-19 as outpatient vs. 2.4% of inpatients with COVID-19) developed recurrent VTE, 34 (1.9 vs. 7.9%) had major bleeding, and 128 (10 vs. 24%) died. On multivariable analysis, inpatients with COVID-19 were at a higher risk of major bleeding (adjusted hazard ratio [HR]: 6.80; 95% CI: 1.52–30.4) or death (adjusted HR: 2.24; 95% CI: 1.40–3.58). In conclusion, using a large multinational registry of patients with COVID-19 who experienced PE, thromboembolic episodes occurring in those recovering from COVID-19 as outpatients were associated with less ominous outcomes than inpatients with COVID-19.


2020 ◽  
Author(s):  
Götz Schmidt ◽  
Fabian Edinger ◽  
Christian Koch ◽  
Matthias Wolff ◽  
Christoph Biehl ◽  
...  

Abstract Background: Treatment of high-risk pulmonary embolism (PE) in perioperative patients remains challenging. Systemic thrombolysis is associated with a high risk of major bleedings and intracranial haemorrhage. High mortality rates are reported for open pulmonary embolectomy. Therefore, postoperative surgical patients may benefit substantially from catheter-directed ultrasound-accelerated thrombolysis (USAT).Case summary: We report two cases of high-risk perioperative PE. Both patients developed severe haemodynamic instability leading to cardiac arrest. After the implantation of a veno-arterial extracorporeal membrane oxygenation (ECMO), they were both successfully treated with USAT. Adequate improvement of right ventricular function was achieved; thus, ECMO could be successfully weaned after three and four days, respectively. Both patients showed favourable outcomes and could be discharged to rehabilitation. Discussion: The current European guideline on treatment of PE offers no specific therapies for perioperative patients with high-risk PE. However, systemic thrombolysis is often excluded due to the perioperative setting and the risk of major bleeding. Catheter-directed thrombolysis was shown to utilise less thrombolytic agent while obtaining comparable thrombolytic effects. The risk for major bleeding (including intracranial haemorrhage) is also significantly lowered. Conclusion: Further prospective randomised controlled trials are necessary to determine the value of USAT treatment of high-risk PE in perioperative patients.


2021 ◽  
Vol 10 (Supplement_1) ◽  
Author(s):  
L Hobohm ◽  
I Sagoschen ◽  
T Gori ◽  
FP Schmidt ◽  
T Muenzel ◽  
...  

Abstract Funding Acknowledgements Type of funding sources: None. Background Extracorporeal membrane oxygenation (ECMO) is a life-saving therapy for patients with acute pulmonary embolism (PE) and concomitant cardiac arrest with the necessity of cardiopulmonary resuscitation (CPR). Little is known about the use and clinical outcome of veno-arterial (VA)-ECMO and adjunctive treatment strategies in patients with acute PE and CPR. Purpose In this context, we aimed to investigate the use of VA-ECMO alone or after systemic thrombolysis and its impact on in-hospital outcomes of patients with acute PE and CPR. Methods We analyzed data on the characteristics, treatments and in-hospital outcomes for all patients with acute PE (ICD-code I26) and CPR in Germany between the years 2005 and 2018 (source: Research Data Center (RDC) of the Federal Statistical Office and the Statistical Offices of the federal states, DRG Statistics 2005-2018, own calculations). Results Between 2005 and 2018, 1,172,354 patients with acute PE (53.5% females) were included in this analysis; of those, 77,196 (6.5%) presented with cardiac arrest and CPR. While more than one fourth of those patients were treated with systemic thrombolysis alone (n = 20,839 patients; 27.0%), a minority received a combination of thrombolysis + VA-ECMO (n = 165; 0.2%) or singular approach with VA-ECMO treatment alone (n = 588; 0.8%). The overall in-hospital mortality rate of PE patients with cardiac arrest was high with 83.8%. Non-survivors were considerable older than survivors (74 [IQR 63-81] vs. 69 [58-77]). In patients treated with VA ECMO alone the mortality rate was 71.1% and 69.7% when patients received Thrombolysis + VA-ECMO. Patients, who received thrombolysis without VA-ECMO had a higher mortality rate (83.8%). In order to investigate the impact of those different treatment strategies, a multivariate logistic regression analysis (adjusted for age, sex and comorbidities) demonstrated the lowest risk for in-hospital death in patients, who underwent the combination of Thrombolysis + VA-ECMO (OR, 0.61 [95% CI, 0.43-0.86], P = 0.004) or VA-ECMO alone (OR, 0.70 [0.58-0.84], P &lt; 0.001) compared to patients without VA-ECMO and without thrombolysis. Use of thrombolysis alone in patients with PE and CPR lowering the risk regarding in-hospital death as well (OR, 0.95 [0.91-0.99], P = 0.013). Regarding temporal trends, the annual use of VA-ECMO increased from 0 in the year 2005 to the number of 138 in 2018 (ß 6.13 (4.62-6.76); p &lt; 0.001) as well as for the combined treatment Thrombolysis + VA-ECMO (from 0 to 39 [ß 4.28 (3.68-4.89); p &lt; 0.001]). Conclusion Patients with acute PE and CPR had a very high in-hospital mortality rate. Our data suggest, that VA-ECMO alone or after systemic thrombolysis should be considered as an option in this outstanding life-threatening situation to improve in-hospital outcome. Furthermore, our data highlight a marked increase in the number of PE patients treated with VA-ECMO indicating the structural health care progress between 2005 and 2018.


2019 ◽  
Vol 21 (Supplement_I) ◽  
pp. I23-I30 ◽  
Author(s):  
Romain Chopard ◽  
Fiona Ecarnot ◽  
Nicolas Meneveau

Abstract Systemic thrombolysis for acute pulmonary embolism (PE) reduces the risk of death and cardiovascular collapse but is associated with an increased rate of bleeding. The desire to minimize the risk of bleeding events has driven the development of catheter-based strategies for pulmonary reperfusion in PE. These catheter-based strategies utilize lower-dose fibrinolytic regimens or purely mechanical techniques to expedite removal of the embolus. Several devices providing mechanical or suction embolectomy and catheter-directed thrombolysis, with or without facilitation by ultrasound, have been tested. Data are inconsistent regarding the efficacy and safety of mechanical and suction embolectomy. The most comprehensive data on catheter-based techniques stem from trials of ultrasound-facilitated catheter fibrinolysis. Ultrasound-facilitated catheter fibrinolysis relieves right ventricular pressure overload with a lower risk of major bleeding and intracranial haemorrhage than historical rates with systemic fibrinolysis. However, further research is required to determine the optimal application of ultrasound-facilitated catheter fibrinolysis and other catheter-based therapies in patients with acute PE.


Author(s):  
Daniel Haines ◽  
Joel Grigsby

This chapter assesses pulmonary embolism (PE), which is an obstruction of the pulmonary circulation by an occlusive material. The material may be thrombus, air, tumor, or fat. PE are classified as acute, subacute, or chronic; but they can be further classified into massive and submassive. Submassive PE is defined as an acute PE without systemic hypotension but with either right ventricular dysfunction or myocardial necrosis, while massive PE is defined as an acute PE with sustained shock. There are several strategies for treating PE depending on the stability of the patient and the location of the clot. Systemic thrombolysis, catheter-directed thrombolysis, and catheter-directed clot removal are all treatment options, if there are no contraindications. Bleeding risk is the largest contraindication for thrombolytic therapy. Meanwhile, surgical embolectomy is warranted for hemodynamically unstable patients as well as patients with contraindications to or who failed thrombolytic therapy and catheter-based approaches. Right ventricular failure is a serious complication following pulmonary embolectomy and is managed by a compilation of volume removal, inotropic support, pulmonary vasodilation, and mechanical support, if needed.


Blood ◽  
2013 ◽  
Vol 122 (21) ◽  
pp. 2380-2380
Author(s):  
Christina Köhler ◽  
Sebastian Werth ◽  
Luise Tittl ◽  
Jan Beyer-Westendorf

Abstract Background and Objectives In the EINSTEIN PE study rivaroxaban (RX) was found to be as effective as warfarin in the treatment of acute pulmonary embolism (PE) with superior safety. However, study results need to be confirmed in unselected PE patients in daily care. Patients and Methods Using prospectively collected data from a large regional registry of patients treated with novel direct oral anticoagulants (NOAC) in the district of Saxony, Germany, we evaluated the rate of recurrent VTE, other cardiovascular complications and bleeding events in patients receiving rivaroxaban for acute PE. In this ongoing registry, a network of 239 physicians enrols up to 2500 daily care NOAC patients who receive central prospective follow up (FU) by the registry office at day 30 day and quarterly thereafter to collect efficacy and safety data. All outcome events are centrally adjudicated using standard scientific definitions. Results Until July 31th 2013, 2249 patients were enrolled. Of these, 72 patients received RX for acute PE treatment (demographic data in table 1). Registry patients were older than the EINSTEIN PE population (67.3 vs. 55.8 years), 55.6% were female and 23.6% were treated for a recurrent VTE. During follow-up, unplanned rivaroxaban discontinuation rates were low (around 5%; table 1). So far, only one recurrent VTE event occurred (1.7 events per 100 patient years). One patient experienced non-fatal ischaemic stroke within 4 weeks after PE diagnosis (1.7 events per 100 patient years). Bleeding complications were frequent but only 2 major bleeding (non-fatal vaginal bleeds) occurred (3.3 events per 100 patient years). During follow-up three patients died of underlying diseases but none of these deaths were related to VTE or bleeding complications. Conclusion Acute PE treatment with rivaroxaban in daily care is effective, safe and well tolerated with low rates of unplanned treatment discontinuation. Thromboembolic and major bleeding complications are rare and seem to occur predominantly in the early phase of PE treatment. At ASH, updated results from our registry will be presented Disclosures: Werth: Bayer Healthcare: Honoraria. Beyer-Westendorf:Pfizer: Research Funding, Speakers Bureau; Boehringer Ingelheim: Research Funding, Speakers Bureau; Bayer Healthcare: Research Funding, Speakers Bureau.


Blood ◽  
2020 ◽  
Vol 136 (Supplement 1) ◽  
pp. 43-43
Author(s):  
Katherine Steckham ◽  
Craig Ainsworth ◽  
Siraj Mithoowani ◽  
Deborah M Siegal

Background: The role of inpatient transthoracic echocardiography (TTE) in patients with acute pulmonary embolism (PE) is unclear. Although right ventricular dysfunction (RVD) predicts adverse outcomes in acute PE, there is no consensus on the optimal TTE findings for prognostication and how they influence management, particularly when CT and/or an elevated cardiac troponin already suggest RVD. Understanding current practices regarding inpatient TTE in acute PE can help direct appropriate use. Our objectives were to (i) characterize inpatient TTE use in adult patients hospitalized with acute PE, (ii) describe and compare findings of RVD by TTE, CT and troponin, and (iii) explore differences in outcomes between patients managed with or without TTE. Methods: We conducted a retrospective cohort study of adult patients hospitalized with acute PE at two academic hospitals in Hamilton, Canada between January and December 2018. Patients with suspected PE that was not objectively confirmed, or PE diagnosed prior to hospitalization were excluded. We also excluded patients who had a TTE prior to the diagnosis of PE. Chi-square tests and independent t-tests were used. P-values less than 0.05 were considered significant. Results: We identified 178 adult patients (mean age 66 ± 15 years; 42% male). Patients were admitted to internal medicine (53%), oncology (19%), surgical specialties (13%) and intensive care units (ICU, 11%). Of 146 patients, 134 (92%) had a PE involving segmental or larger vessels. TTE was conducted in 86 (48%) patients. Systemic thrombolysis was administered to 11 (6%) patients. A higher proportion of patients with an elevated troponin (66% vs. 35% p&lt;0.001) or evidence of RV strain on CT (65% vs. 35%, p=0.001) underwent TTE compared to those without these findings. Patients admitted to the ICU more frequently underwent TTE (69% vs. 44%, p=0.012). RV size and function were normal in 49 (59%) and 53 (63%) cases, respectively. Patients with RV strain on CT were more likely to have RV enlargement (58% vs. 30%, p=0.04) and RVD (58% vs. 25%, p=0.011) on TTE. However, right ventricular internal dimension in diastole (RVIDd) (3.9 ± 0.75 cm vs. 3.7 ± 0.78 cm) and tricuspid annular plane systolic excursion (TAPSE) (1.8 ± 0.44 cm vs. 2.0 ± 0.38 cm) were not statistically different between patients with or without RV strain on CT. A higher proportion of patients with an elevated troponin had RV enlargement (58% vs. 14%, p=0.001) and RVD (50% vs. 18%, p=0.018) on TTE. Length of hospital admission (16 ± 28 days vs. 11 ± 23 days) and in-hospital death (7% vs. 11%) were not statistically different between patients with or without TTE. Conclusions: Inpatient TTE is conducted frequently in hospitalized patients with acute PE, especially in those with evidence of RV strain based on CT and/or an elevated cardiac troponin. Our results suggest that patients with findings of RV strain on CT are more likely to have RV enlargement and RVD on TTE. Future studies should evaluate the diagnostic utility of CT and/or troponin for RVD in the setting of acute PE, which may reduce the routine use of inpatient TTE and associated healthcare resources and costs. Disclosures Mithoowani: Leo Pharma: Honoraria. Siegal:Portola: Honoraria; Novartis: Honoraria; Leo Pharma: Honoraria; Bayer: Honoraria; BMS Pfizer: Honoraria.


2021 ◽  
Vol 10 (1) ◽  
Author(s):  
Götz Schmidt ◽  
Fabian Edinger ◽  
Christian Koch ◽  
Matthias Wolff ◽  
Christoph Biehl ◽  
...  

Abstract Introduction Treatment of high-risk pulmonary embolism (PE) in perioperative patients remains challenging. Systemic thrombolysis is associated with a high risk of major bleedings and intracranial haemorrhage. High mortality rates are reported for open pulmonary embolectomy. Therefore, postoperative surgical patients may benefit substantially from catheter-directed ultrasound-accelerated thrombolysis (USAT). Case presentation We report two cases of high-risk perioperative PE. Both patients developed severe haemodynamic instability leading to cardiac arrest. After the implantation of a veno-arterial extracorporeal membrane oxygenation (ECMO), they were both successfully treated with USAT. Adequate improvement of right ventricular function was achieved; thus, ECMO could be successfully weaned after 3 and 4 days, respectively. Both patients showed favourable outcomes and could be discharged to rehabilitation. Conclusion Current guidelines on treatment of PE offer no specific therapies for perioperative patients with high-risk PE. However, systemic thrombolysis is often excluded due to the perioperative setting and the risk of major bleeding. Catheter-directed thrombolysis was shown to utilise less thrombolytic agent while obtaining comparable thrombolytic effects. The risk for major bleeding (including intracranial haemorrhage) is also significantly lowered. Until further trials determining the value of adopted treatment strategies of high-risk PE in perioperative patients are available, USAT should be considered in similar cases.


Author(s):  
Donna Shu‐Han Lin ◽  
Yu‐Sheng Lin ◽  
Cho‐Kai Wu ◽  
Heng‐Hsu Lin ◽  
Jen‐Kuang Lee

Background This study compared the efficacy and safety between catheter‐directed thrombolysis (CDT) and systemic thrombolysis for patients with acute pulmonary embolism (PE) with midterm follow‐up. Methods and Results We conducted a prospective open cohort study by using data from the Taiwan National Health Insurance Research Database for 2001 to 2013. Patients who were first admitted for PE and were treated by either systemic thrombolysis or CDT were included and compared. Inverse probability of treatment weighting, based on the propensity score, was used to mitigate possible selection bias. A total of 145 CDT‐treated and 1158 systemic thrombolysis–treated patients with PE were included. The in‐hospital mortality rate was significantly lower in the CDT group (12.7% versus 21.4%; odds ratio, 0.49; 95% CI, 0.36–0.67) after inverse probability of treatment weighting. No significant differences between the groups were observed for the safety (bleeding) outcomes. In patients who survived the index PE admission, the 1‐year all‐cause mortality rate was significantly lower in the CDT group after inverse probability of treatment weighting (12.2% versus 13.2%; hazard ratio [HR], 0.73; 95% CI, 0.56–0.94). Treatment with CDT was also associated with lower risks of recurrent PE (9.3% versus 17.5%; subdistribution HR, 0.52; 95% CI, 0.41–0.66). The difference remained through the last follow‐up. Conclusions Among patients with PE requiring reperfusion therapy, those accepting CDT had lower all‐cause mortality and recurrent PE over both short‐term and midterm follow‐up periods than those receiving systemic thrombolysis. The bleeding risk was similar for both groups. These findings should be cautiously validated in future randomized trials.


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