A Safety and Feasibility Single-Arm Study of a Novel Catheter Thrombectomy Device for the Treatment of Pulmonary Embolism (ENGULF).

Background: Despite advances in therapy options, pulmonary embolism (PE) continues to carry a high risk of mortality and morbidity. Currently, therapeutic options are limited with only 2 US Food and Drug Administration-cleared catheter-based embolectomy devices approved for the treatment of intermediate-risk PE. The novel Helo PE thrombectomy catheter (Endovascular Engineering, Inc) has a flexible and collapsible funnel with an internal agitator for a dual mechanism of treatment for acute PE. We sought to investigate the safety and feasibility of the novel Helo PE thrombectomy catheter in intermediate-risk PE. Methods: A prospective, single-arm feasibility study evaluating the Helo PE catheter was performed in patients presenting with intermediate-risk PE. Patients underwent preprocedural and postprocedural computed tomography angiography. Primary efficacy was the difference in preprocedural to postprocedural right ventricle/left ventricle (RV/LV) ratio. Primary and secondary safety outcomes were all-cause mortality, major life-threatening bleeding, device-related serious adverse events, pulmonary or cardiac injury, and clinical decompensation at 48 hours postprocedure and at 30 days. Results: A total of 25 patients from 8 centers were consented and included in the analysis. Preprocedural computed tomography angiography revealed an RV/LV ratio of 1.53 ± 0.27. All patients underwent a successful thrombectomy procedure. Postprocedure, the RV/LV ratio was reduced to 1.15 ± 0.18, translating into a 23.2 ± 12.81% decrease from baseline. No patients underwent adjunctive thrombolysis. Two patients had adjunctive catheter-directed embolectomy with an alternative device. Two patients had postprocedural anemia requiring transfusion but did not meet criteria for major life-threatening bleeding by VARC-2 criteria. There were no major adverse events including no deaths, major bleeding, pulmonary injury, or vascular complications at 48 hours or 30 days post procedure. Conclusions: In this multicenter first-in-human study, use of the Helo PE thrombectomy catheter was feasible and safe for the treatment of acute PE.

The Challenge of Managing a Primary Aortic Mural Thrombus: Outcomes and Technical Considerations.

Background: Embolization to multiple arterial beds associated with primary aortic mural thrombus (PAMT) could result in high morbidity and mortality. There are no recommendations to dictate the best management. This study aims to describe our experience in managing this rare disease. Methods: A retrospective review of all patients affected by PAMT treated at our institution between January 2015 and December 2021 was performed. Recorded data included demographics, prothrombotic risk factors, imaging findings, clinical presentation, and treatment. Primary outcomes comprised thrombus recurrence, major amputation, and death. Results: Thirteen patients with PAMT have been included. The median age was 52 years (36-68 years), and the male/female ratio was 1:1.6. The diagnosis of PAMT was made by computed tomography angiography (CTA) in all cases. Prothrombotic conditions were identified in 92% of cases, and most patients (92%) had thoracic PAMT. The most common presentation was acute limb ischemia after thrombus embolization (85%), requiring surgical revascularization. Anticoagulation was promptly started in all patients. Two patients developed heparin-induced thrombocytopenia. Recurrence of embolization/thrombosis was observed in 54% of patients; two underwent endovascular thrombus exclusion with a stent graft. We identified one PAMT-related death and one major amputation with a median follow-up time of 39 months (12-64 months). Conclusion: Anticoagulation alone as initial therapy could completely resolve PAMT but is associated with high embolization recurrence. Thoracic endovascular aortic repair is feasible and could prevent additional embolization. However, the criteria for its use as a first-line therapy still need to be defined. Our study highlights the importance of closely monitoring these patients.

Mechanical Thrombectomy for High-Risk Pulmonary Embolism: Insights From the US Cohort of the FLASH Registry.

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

Clinical and radiographic outcomes after mechanical thrombectomy in medium-vessel posterior cerebral artery occlusions: Subgroup analysis from STAR.

BACKGROUND: Whereas mechanical thrombectomy (MT) has become standard-of-care treatment for patients with salvageable brain tissue after acute stroke caused by large-vessel occlusions, the results of MT in patients with medium-vessel occlusions (MEVOs), particularly in the posterior cerebral artery (PCA), are not well known. METHODS: Using data from the international Stroke Thrombectomy and Aneurysm Registry (STAR), we assessed presenting characteristics and clinical outcomes for patients who underwent MT for primary occlusions in the P2 PCA segment. As a subanalysis, we compared the PCA MeVO outcomes with STAR's anterior circulation MeVO outcomes, namely middle cerebral artery (MCA) M2 and M3 segments. RESULTS: Of the 9812 patients in STAR, 43 underwent MT for isolated PCA MeVOs. The patients' median age was 69 years (interquartile range 61-79), and 48.8% were female. The median NIH Stroke Scale score was 9 (range 6-17). After recanalization, 67.4% of patients achieved successful recanalization (modified treatment in cerebral infarction score [mTICI] ≥ 2b), with a first-pass success rate of 44.2%, and 39.6% achieved a modified Rankin score of 0-2 at 90 days. Nine patients (20.9%) had died by the 90-day follow-up. In comparison with M2 and M3 MeVOs, there were no differences in presenting characteristics among the three groups. Patients with PCA MeVOs were less likely to undergo intra-arterial thrombolysis (4.7% PCA vs. 10.1% M2 vs. 16.2% M3, p = 0.046) or to achieve successful recanalization (mTICI ≥ 2b, 67.4%, 86.7%, 82.3%, respectively, p < 0.001); however, there were no differences in the rates of successful first-pass recanalization (44.2%, 49.8%, 52.3%, respectively, p = 0.65). CONCLUSIONS: We describe the STAR experience performing MT in patients with PCA MeVOs. Our analysis supports that successful first-pass recanalization can be achieved in PCA MEVOs at a rate similar to that in MCA MeVOs, although further study and possible innovation may be necessary to improve successful PCA MeVO recanalization rates.

Ultrasound-assisted catheter-directed thrombolysis versus surgical pulmonary embolectomy for intermediate-high or high-risk pulmonary embolism: a randomized phase II non-inferiority trial.

OBJECTIVES: We hypothesized that ultrasound-assisted thrombolysis (USAT) is non-inferior to surgical pulmonary embolectomy (SPE) to improve right ventricular (RV) function in patients with acute pulmonary embolism (PE). METHODS: In a single-centre, non-inferiority trial, we randomly assigned 27 patients with intermediate-high or high-risk acute PE to undergo either USAT or SPE stratified by PE risk. Primary and secondary outcomes were the baseline-to-72-h difference in right-to-left ventricular (RV/LV) ratio and the Qanadli pulmonary occlusion score, respectively, by contrast-enhanced chest-computed tomography assessed by a blinded CoreLab. RESULTS: The trial was prematurely terminated due to slow enrolment. Mean age was 62.6 (SD 12.4) years, 26% were women, and 15% had high-risk PE. Mean change in RV/LV ratio was -0.34 (95% CI -0.50 to -0.18) in the USAT and -0.53 (95% CI -0.68 to -0.38) in the SPE group (mean difference: 0.152; 95% CI 0.032-0.271; Pnon-inferiority = 0.80; Psuperiority = 0.013). Mean change in Qanadli pulmonary occlusion score was -7.23 (95% CI -9.58 to -4.88) in the USAT and -11.36 (95% CI -15.27 to -7.44) in the SPE group (mean difference: 5.00; 95% CI 0.44-9.56, P = 0.032). Clinical and functional outcomes were similar between the 2 groups up to 12 months. CONCLUSIONS: In patients with intermediate-high and high-risk acute PE, USAT was not non-inferior when compared with SPE in reducing RV/LV ratio within the first 72 h. In a post hoc superiority analysis, SPE resulted in greater improvement of RV overload and reduction of thrombus burden.

Clinical Outcome Using Different Catheter Interventional Treatment Modalities in High-Risk Pulmonary Artery Embolism.

BACKGROUND: For patients with high-risk pulmonary artery embolism (PE), catheter-directed therapies pose a viable alternative treatment option to systemic thrombolysis or anticoagulation. Right now, there are multiple devices available which have been proven to be safe and effective in lower-risk settings. There is, however, little data comparing their efficacies in high-risk PE. METHODS: We performed a retrospective, single-center study on patients with high-risk PE undergoing catheter interventional treatment. Patients receiving large-bore catheter thrombectomy were compared to patients receiving alternative treatment forms. RESULTS: Of the 20 patients included, 9 received large-bore thrombectomy, and 11 received alternative interventional treatments. While the baseline characteristics were comparable between the two groups, periprocedural and in-hospital mortality tended to be significantly lower with large-bore thrombectomy when compared to other treatment forms (0 vs. 55% and 33 vs. 82%, p = 0.07 and 0.01, respectively). CONCLUSIONS: In this small, retrospective study, large-bore thrombectomy was associated with lower mortality as compared to alternative treatment forms. Future prospective research is needed to corroborate these findings.

Successful Recanalization and Neurological Restoration in Cancerous Embolic Cerebral Infarction via Endovascular Stent-Retriever Embolectomy.

Mechanical thrombectomy has emerged as a promising treatment for acute ischemic stroke caused by large vessel occlusion. However, cases involving cancerous emboli retrieved during endovascular embolectomy are rare. We present a case of a 65-year-old man with a history of heavily treated rectal cancer, who developed a middle cerebral artery (MCA) infarction due to metastatic adenocarcinoma. The patient presented with sudden onset right-side weakness, right facial palsy, global aphasia, and left gaze deviation, with a National Institutes of Health Stroke Scale (NIHSS) score of 16. Following intravenous thrombolysis, endovascular thrombectomy was performed, achieving nearly complete recanalization. Pathological examination of the retrieved thrombus revealed metastatic adenocarcinoma of rectal origin. The patient's neurological deficits gradually improved, and he was successfully discharged to undergo further palliative therapy. This case underscores the importance of considering mechanical thrombectomy for patients with advanced solid organ malignancy presenting with acute ischemic stroke, even when the etiology could be a tumor embolus. Our findings highlight the potential for mechanical thrombectomy to restore neurological function in such cases, allowing patients to proceed to the next level of care with a reasonably good post-stroke quality of life.

The Outcomes of Surgical Pulmonary Embolectomy for Pulmonary Embolism: A Meta-Analysis.

Objectives: The purpose of this study is to assess the efficacy, short- and long-term cardiovascular and non-cardiovascular mortalities and postoperative morbidities of surgical pulmonary embolectomy (SPE) for patients with massive or submassive pulmonary embolism. Methods: A comprehensive literature review was performed to identify articles reporting SPE for pulmonary embolism. The outcomes included in-hospital and long-term mortality in addition to postoperative morbidities. The random effect inverse variance method was used. Cumulative meta-analysis, leave-one-out sensitivity analysis, subgroup analysis and meta-regression were performed. Results: Among the 1949 searched studies in our systematic literature search, 78 studies met our inclusion criteria, including 6859 cases. The mean age ranged from 42 to 65 years. The percentage of males ranged from 25.6% to 86.7%. The median rate of preoperative cardiac arrest was 27.6%. The percentage of contraindications to preoperative systemic thrombolysis was 30.4%. The preoperative systemic thrombolysis use was 11.5%. The in-hospital mortality was estimated to be 21.96% (95% CI: 19.21-24.98); in-hospital mortality from direct cardiovascular causes was estimated to be 16.05% (95% CI: 12.95-19.73). With a weighted median follow-up of 3.05 years, the late cardiovascular and non-cardiovascular mortality incidence rates were 0.39 and 0.90 per person-year, respectively. The incidence of pulmonary bleeding, gastrointestinal bleeding, surgical site bleeding, non-surgical site bleeding and wound complications was 0.62%, 4.70%, 4.84%, 5.80% and 7.2%, respectively. Cumulative meta-analysis showed a decline in hospital mortality for SPE from 42.86% in 1965 to 20.56% in 2024. Meta-regression revealed that the publication year and male sex were associated with lower in-hospital mortality, while preoperative cardiac arrest, the need for inotropes or vasopressors and preoperative mechanical ventilation were associated with higher in-hospital mortality. Conclusions: This study demonstrates acceptable perioperative mortality rates and late cardiovascular and non-cardiovascular mortality in patients who undergo SPE for massive or submassive pulmonary embolism.

Evolution of Pulmonary Embolism Response Teams in the United States: A Review of the Literature.

Pulmonary embolism (PE) is a significant cause of cardiovascular mortality, with varying presentations and management challenges. Traditional treatment approaches often differ, particularly for submassive/intermediate-risk PEs, because of the lack of clear guidelines and comparative data on treatment efficacy. The introduction of pulmonary embolism response teams (PERTs) aims to standardize and improve outcomes in acute PE management through multidisciplinary collaboration. This review examines the conception, evolution, and operational mechanisms of PERTs while providing a critical analysis of their implementation and efficacy using retrospective trials and recent randomized trials. The study also explores the integration of advanced therapeutic devices and treatment protocols facilitated by PERTs. PERT programs have significantly influenced the management of both massive and submassive PEs, with notable improvements in clinical outcomes such as decreased mortality and reduced length of hospital stay. The utilization of advanced therapies, including catheter-directed thrombolysis and mechanical thrombectomy, has increased under PERT guidance. Evidence from various studies, including those from the National PERT Consortium, underscores the benefits of these multidisciplinary teams in managing complex PE cases, despite some studies showing no significant difference in mortality. PERT programs have demonstrated potentials to reduce morbidity and mortality, streamlining the use of healthcare resources and fostering a model of sustainable practice across medical centers. PERT program implementation appears to have improved PE treatment protocols and innovated advanced therapy options, which will be further refined as they are employed in clinical practice. The continued expansion of the capabilities of PERTs and the forthcoming results from ongoing randomized trials are expected to further define and optimize management protocols for acute PEs.

Acute Infrarenal Abdominal Aortic and Bilateral Common Iliac Artery Occlusions in an Elderly Female: A Case Report.

Acute aortic occlusions (AAOs) are rare vascular emergencies associated with high morbidity and mortality. Presenting signs and symptoms vary but typically involve the lower extremities and include mottled skin with diminished pedal pulses, paresis, and severe pain. Prompt recognition and imaging are necessary to prevent rapid deterioration, which can lead to loss of limb or death. Treatment includes surgical or endovascular interventions based on patient-associated risk factors and clot location. We present a 76-year-old female who arrived at the emergency department with an AAO involving the infrarenal abdominal aorta and bilateral common iliac arteries. Efficient physical examination and utilization of computed tomography with angiography of the abdomen and pelvis allowed for the appropriate recognition of the AAO and subsequent successful surgical embolectomy. This case report underscores the importance of an expeditious clinical and radiographic evaluation in patients presenting with lower extremity pain and weakness.

Long-Term Echocardiographic and Clinical Outcomes After Invasive and Non-Invasive Therapies for Sub-Massive and Massive Acute Pulmonary Embolism.

AIM: Acute pulmonary embolism (PE) is a significant cause of mortality in the hospital setting. The objective of this study was to outline the long-term outcomes after surgical and non-surgical management for patients with massive and submassive PE. METHODS: Population cohort observational study evaluating all patients who presented to three tertiary hospitals in the state of Western Australia with access to cardiothoracic services over 5 years (2013-2018). Reviewed notes of all patients as well as radiology, linked mortality data and all available echocardiography studies at the primary hospital. RESULTS: In total, 245 patients were identified, of which 41 received surgical management and 204 non-surgical management; demographic data was similar. Clinically, the surgical group had higher rates of shock requiring vasopressors, severe bradycardia, or cardiopulmonary resuscitation prior to intervention. The 28-day mortality was not statistically significantly different between the surgical embolectomy group (2/41 [4.2%]) and the non-surgical group (17/201 [8.3%]) (p=0.382). There was no difference in 12-month mortality, including when this was adjusted for vasopressors, right ventricular (RV) strain, troponin, and brain natriuretic peptide. In the massive PE sub-group, 28-day mortality was not significantly different: 2/29 (6.9%) surgical group vs 7/34 (20.2%) non-surgical group (p=0.064). Higher rates of severe RV impairment and dilatation were present in the surgical group. All patients with available echocardiography studies at outpatient follow-up returned to normal or mild RV impairment. CONCLUSION: Patients who presented with massive or submassive PE had similar outcomes whether treated with surgical or non-surgical management. Surgical embolectomy is a safe option in a cardiothoracic centre setting.

Pulmonary Embolism in Donor Lungs-Incidence and Management.

In efforts to decrease the mortality on the waiting list for lung transplantation, alternatives to increase the donor pool have been explored. Caution must be used when accepting donor lungs with pulmonary embolism (PE), as prior evidence has shown mixed results after transplantation of donor lungs with PE. However, the mere diagnosis of PE on imaging should not be the sole reason for the exclusion of these donors for transplant, and they should be reviewed as any other donor. A comprehensive evaluation should be performed for every donor, with a special focus on abnormalities of gas exchange and gross pathologic characteristics during procurement.

Pulmonary Embolism Following Lung Transplantation: Prevention and Management.

Thromboembolic events are the third leading cardiovascular diagnosis following stroke and myocardial infarction. In the United States, 300,000 to 600,000 people per year are diagnosed with venous thromboembolism, either deep venous thrombosis or pulmonary embolism (PE). Of those patients, thousands die from PE despite heightened vigilance and improved therapies. Lung transplant recipients are at increased risk of developing PE due to multiple risk factors unique to this population. Additionally, the transplant recipients are more susceptible to morbid complications from PE. As a result, prevention, timely recognition, and intervention of PE in the lung transplant population are of the utmost importance.

A Brief Historical Perspective on Pulmonary Embolism.

Pulmonary embolism is a major cause of mortality worldwide. In this historical perspective, we aim to provide an overview of the rich medical history surrounding pulmonary embolism. We highlight Virchow's first steps toward understanding the pathophysiology in the 1800s. We see how those insights inspired early attempts at intervention such as surgical pulmonary embolectomy and caval ligation. Those early interventions were refined and ultimately led to the development of inferior vena cava filters, the earliest clinical applications of anticoagulation, and even apparently disparate medical advances such as the successful development of cardiopulmonary bypass. We also see how the diagnosis of pulmonary embolism has evolved from rudimentary monitoring of vitals and symptoms to the development of evermore sophisticated tests such as contrast tomography angiography and echocardiography. Finally, we discuss current approaches to diagnosis, classification, and myriad treatments including anticoagulation, thrombolysis, catheter-directed interventions, surgical embolectomy, and extracorporeal membrane oxygenation guided by Pulmonary Embolism Response Teams.

Successful Treatment of Massive Pulmonary Embolism in Pregnancy with Catheter-Directed Embolectomy.

Introduction Pulmonary embolism (PE) is associated with approximately 10.5% of maternal deaths in the United States. Despite heightened awareness of its mortality potential, there islittle data available to guide its management in pregnancy. We present the case of a massive PE during gestation successfully treated with catheter-directed embolectomy. Case Presentation A 37-year-old G2P1001 presented with a syncopal episode preceded by dyspnea and chest pain. Upon presentation, she was hypotensive, tachycardiac, and hypoxic. Imaging showed an occlusive bilateral PE, right heart strain, and a possible intrauterine pregnancy. Beta-human chorionic gonadotropin was positive. She was taken emergently for catheter-directed embolectomy. Her condition immediately improved afterward. Postprocedure pelvic ultrasound confirmed a viable intrauterine pregnancy at 10 weeks gestation. She was discharged with therapeutic enoxaparin and gave birth to a healthy infant at 38 weeks gestation. Conclusion Despite being the gold standard for PE treatment in nonpregnant adults, systemic thrombolysis is relatively contraindicated in pregnancy due to concern for maternal or fetal hemorrhage. Surgical or catheter-based thrombectomies are rarely recommended. Limited alternative options force their consideration, particularly in a hemodynamically unstable patient. Catheter-directed embolectomy can possibly bypass such complications. Our case exemplifies the consideration of catheter-directed embolectomy as the initial treatment modality of a hemodynamically unstable gestational PE.

Transcatheter Aspiration and Mechanical Embolectomy of an Intracardiac Mass.

The management of pulmonary embolus and intracardiac masses is rapidly evolving with the availability of transcatheter aspiration devices. We describe the utility of a transcatheter aspiration device in management of a patient with pulmonary embolus and a right atrial mass in transit after spinal surgery where a topical hemostatic agent was used to control intraoperative bleeding.

The Mysterious Risk of Arterial Thrombosis With COVID-19: A Case Series of Acute Limb Ischaemia in Vaccinated Patients.

Introduction Coronavirus-19 (COVID-19) plays a vital role in viral-induced hypercoagulability through the initiation of a cytokine storm. This mechanism has been found to predispose unvaccinated patients to systemic complications including arterial thrombosis (AT) with poor 30-day amputation-free survival rates. There remains, however, little understanding regarding the incidence in patients who have received a COVID-19 vaccination. This study aims to assess the incidence, management and outcomes of vaccinated patients with COVID-19 who develop thrombotic complications to reduce amputation and direct mortality. Methods The case notes of all emergency patients with COVID-19 referred to the vascular services in a tertiary referral centre between November 2021 and April 2022 were reviewed. Patients who were unvaccinated or admitted with stroke or coronary thrombosis were excluded. The study was undertaken to measure 30-day outcomes. Results Between November 2021 and April 2022, 167,290 people tested positive for COVID-19 in Norfolk. Thirty-one patients under the vascular service had COVID-19, of which, one patient was unvaccinated. Only one vaccinated patient was referred with AT and had a positive COVID-19 result two days after admission. Above-knee amputation was performed within 30 days and he survived. Seventeen percent of patients contracted COVID-19 during their hospital admission. Conclusion The incidence of acute limb ischaemia in vaccinated patients is low; however, the 30-day outcomes remain poor. Compared to unvaccinated patients, there was a significant reduction in the presentation of AT in vaccinated patients during that timeframe, despite a higher background number of COVID-19 cases. Therefore, vaccination may minimise the risk of AT.