Percutaneous pulmonary thrombectomy with aspiration catheters in patients with high-risk pulmonary embolism and absolute contraindication to systemic thrombolysis.

BACKGROUND: High-risk Pulmonary Embolism (PE) mortality remains very high. Systemic thrombolysis is effective but carries significant complications and contraindications related to the hemorrhagic risk. Percutaneous thrombectomy using aspiration catheters may be an alternative in patients with a high bleeding risk. OBJECTIVE: This study aimed to evaluate the results of catheter-directed thrombectomy using aspiration dedicated catheters in patients with high-risk PE and absolute contraindication to systemic thrombolysis, with specific focus on procedural success, safety, and in-hospital outcomes. METHODS: A prospective study enrolled all consecutive patients diagnosed with high-risk pulmonary embolism and absolute contraindication to systemic thrombolysis, who underwent percutaneous pulmonary thrombectomy using dedicated aspiration catheters. The study documented the effectiveness and complications of the procedure, as well as patient outcomes at discharge and during the follow-up period. RESULTS: Thirteen patients underwent percutaneous pulmonary thrombectomy using aspiration dedicated catheters. The procedure was successful for all patients, resulting in hemodynamic and respiratory improvement within the first 24 h. No deaths attributable to cardiovascular or respiratory causes occurred during admission or follow-up. Furthermore, no serious adverse events or complications were reported during the procedure or hospitalization. CONCLUSIONS: Percutaneous pulmonary thrombectomy with dedicated aspiration catheters in patients with high-risk pulmonary embolism and contraindications to systemic thrombolysis was associated with excellent clinical results and low rate of complications.

One-year limb salvage and quality of life following mechanical aspiration thrombectomy in patients with acute lower extremity ischemia.

OBJECTIVE: Lower extremity acute limb ischemia (LE-ALI) is associated with high morbidity and mortality rates, and a burden on patient quality of life (QoL). There is limited medium- to long-term evidence on mechanical aspiration thrombectomy (MT) in patients with LE-ALI. The STRIDE study was designed to assess safety and efficacy of MT using the Indigo Aspiration System in patients with LE-ALI. Thirty-day primary and secondary endpoints and additional outcomes were previously published. Here, we report 365-day secondary endpoints and QoL data from STRIDE. METHODS: STRIDE was a multicenter, prospective, single-arm, observational cohort study that enrolled 119 patients across 16 sites in the United States and Europe. Patients were treated first-line with MT using the Indigo Aspiration System (Penumbra, Inc). The study completed follow-up in October 2023. Secondary endpoints at 365 days included target limb salvage and mortality. Additionally, the VascuQoL-6 questionnaire, developed for evaluating patient-centered QoL outcomes for peripheral arterial disease, was assessed at baseline and follow-up through 365 days. RESULTS: Seventy-three percent of patients (87/119) were available for 365-day follow-up. Mean age of these patients was 65.0 ± 13.3 years, and 44.8% were female. Baseline ischemic severity was classified as Rutherford I in 12.6%, Rutherford IIa in 51.7%, and Rutherford IIb in 35.6%. In general, baseline and disease characteristics (demographics, medical history, comorbidities, target thrombus) of these patients are similar to the enrolled cohort of 119 patients. The secondary endpoints at 365 days for target limb salvage was 88.5% (77/87) and mortality rate was 12.0% (12/100). VascuQoL-6 improved across all domains, with a median total score improvement from 12.0 (interquartile range, 9.0-15.0) at baseline to 19.0 (interquartile range, 16.0-22.0) at 365 days. CONCLUSIONS: These 365-day results from STRIDE demonstrate that first-line MT with the Indigo Aspiration System for LE-ALI portray continued high target limb salvage rates and improved patient-reported QoL. These findings indicate Indigo as a safe and effective therapeutic option for LE-ALI.

Endovascular treatment of embolism-related acute basilar artery occlusion stroke: ADAPT versus stent retriever thrombectomy.

PURPOSE: This study aimed to compare the efficacy and safety of a direct aspiration first-pass technique (ADAPT) and stent retriever thrombectomy (SRT) technique in embolism-related acute basilar artery occlusion (EMB-ABAO). METHODS: We collected data from patients with EMB-ABAO in multiple stroke centers from January 2017 to February 2024. We defined two groups of enrolled patients, the ADAPT group and the SRT group. The primary outcome was the first attempt recanalization (FAR) rate. Secondary outcomes were the puncture to recanalization (PTR) time and the 90-day favorable functional outcome. The safety outcome was 90-day all-cause mortality rate. RESULTS: A total of 406 patients were screened for endovascular treatment (EVT) of ABAO ischemic stroke, and 108 patients were identified with EMB-ABAO stroke. Among these, 96 patients were included in the final analysis. Among them, 58 (60.42%) were in the ADAPT group, and 38 (39.58%) were in the SRT group. Compared with the SRT group, the ADAPT group achieved FAR more frequently (60.34% versus 39.47%; p = 0.045) and a higher 90-day favorable functional outcome rate (44.83% versus 36.84%; p = 0.438). The median PTR time of the ADAPT group was significantly shorter than that of the SRT group (42 versus 105 min; p < 0.001). CONCLUSION: In cases where EMB-ABAO is suspected, ADAPT was superior to SRT in terms of FAR rate and PTR time, but the 90-day mRS scores had no statistical significance. Given the reduced time to recanalization with ADAPT, an initial attempt at recanalization with ADAPT may be necessary before stent retriever. However, due to the study limitations, these findings should be interpreted as preliminary and require further study.

Clinical, Functional, and Quality of Life Outcomes after Computer Assisted Vacuum Thrombectomy for Pulmonary Embolism: Interim Analysis of the STRIKE-PE Study.

PURPOSE: To report 90-day results from the first interim analysis of the STRIKE-PE study, which is evaluating safety, effectiveness, and functional and quality of life (QoL) outcomes of Computer Assisted Vacuum Thrombectomy (CAVT) with the Indigo Aspiration System for the treatment of acute pulmonary embolism (PE). METHODS: STRIKE-PE is a prospective, international, multicenter study that will enroll 600 adult patients with acute PE of ≤14 days and a right ventricle/left ventricle (RV/LV) ratio of ≥0.9 who receive first-line endovascular treatment with CAVT. Primary endpoints are change in RV/LV ratio and incidence of composite major adverse events (MAEs) within 48 hours. Secondary endpoints include functional and QoL assessments. RESULTS: The first 150 consecutive patients were treated with Lightning 12 CAVT. Mean age was 61.3 years, 54.7% were men, 94.7% presented with intermediate-risk PE, and 5.3% presented with high-risk PE. Median thrombectomy and procedure times were 33.5 minutes and 70 minutes, respectively, resulting in a mean reduction in systolic pulmonary artery pressure of 16.3% (P < .001). Mean RV/LV ratio decreased from 1.39 before thrombectomy to 1.01 at 48 hours, a 25.7% reduction (P < .001). Four patients (2.7%) experienced a composite MAE within 48 hours. At 90-day follow-up, patients exhibited statistically significant improvements in the Borg dyspnea scale and QoL measures, and the NYHA class distribution returned to that reported before the index PE. CONCLUSION: These interim results demonstrate a rapid reduction in RV/LV ratio, achieved with a fast thrombectomy time while maintaining safety. This is accompanied by improvements in 90-day functional and QoL outcomes.

Aspiration Thrombectomy Using Inari FlowTriever System for Inferior Vena Cava Tumor Thrombus: A Case Report.

Pharmacomechanical therapy and catheter-directed thrombolysis are potent treatments for venous thromboembolism. However, limited data exist regarding the management of thrombi in the inferior vena cava (IVC). IVC thrombus resulting from tumors is a particularly uncommon condition. Managing IVC tumor thrombi poses even greater challenges, as conventional therapies such as systemic anticoagulation and thrombolysis are often ineffective. In this report, we present the case of a 73-year-old male with an inferior vena cava tumor thrombus successfully managed through aspiration thrombectomy utilizing the Inari FlowTriever system.

Percutaneous aspiration of aortic valve vegetation in a patient with aortic valve endocarditis.

Key Clinical Message: Percutaneous aspiration for debulking of vegetations in right-sided infective endocarditis has been well-described, however, this technique can be employed successfully for left-sided vegetations in select high-risk patients. Abstract: We report a case of percutaneous aspiration of an aortic valve vegetation in a patient with prosthetic valve endocarditis. This novel approach was selected after patient declined surgical intervention for an enlarging vegetation despite antibiotic therapy. The procedure was successful, resulting in the complete removal of solid vegetation without complications.

A Case of Carotid Sinus Reflex Caused by Manual Aspiration Thrombectomy Using a Balloon Guide Catheter.

When starting a mechanical thrombectomy, manual aspiration with balloon guide catheters inserted into the internal carotid artery (ICA) is an efficient method for thrombus aspiration. However, no complications associated with this procedure have been reported. This study describes the case of a 76-year-old man who presented to our hospital with total aphasia and complete right-sided paralysis due to chronic atrial fibrillation and left occlusion of the ICA. When the balloon guide catheter was inserted and inflated at the origin of the left ICA, the patient's systolic blood pressure suddenly decreased from 114 mm Hg to 44 mm Hg. This sudden hypotension may have been caused by the carotid sinus reflex. Hypotension improved following balloon deflation. The procedure was continued, resulting in complete recanalization of the left ICA. The patient died from acute exacerbation of interstitial pneumonia. Although this complication is rare, similar phenomena have been recognized in carotid artery stenting and the use of flow-diverting devices. To the best of our knowledge, this is the first report of a case wherein the carotid sinus reflex was induced by manual aspiration using a balloon guide catheter placed in the ICA. Clinicians should recognize the importance of ensuring that the proximal end of the balloon crosses the carotid sinus when dilating and occluding the ICA with a balloon to avoid the carotid sinus reflex.

Emergent Coronary Thrombectomy for Acute Myocardial Infarction Immediately Following Craniotomy with Tumor Resection.

The management of perioperative acute myocardial infarction (AMI) following oncologic neurosurgery requires balancing competing risks of myocardial ischemia and postoperative bleeding. There are limited human data to establish the safest timing of antiplatelet or anticoagulation therapy following neurosurgical procedures. For patients with malignancy experiencing AMI in the acute postoperative period, staged percutaneous coronary intervention (PCI) with upfront coronary aspiration thrombectomy followed by delayed completion PCI may offer an opportunity for myocardial salvage while minimizing postoperative bleeding risks. CYP2C19 genotyping and platelet aggregation studies can help confirm adequate platelet inhibition once antiplatelet therapy is resumed.

Predictors of Outcome after Direct Aspiration of Basilar Artery Occlusion.

Background: Basilar artery occlusion (BAO) is a serious disease with a poor prognosis if left untreated. Endovascular therapy (EVT) is the most effective treatment that is able to reduce mortality and disability. Treatment results are influenced by a wide range of factors that have not been clearly identified. In the present study, direct aspiration was chosen as a first-line treatment. The safety and effectiveness of direct aspiration in BAO were determined, and factors affecting patient outcomes were identified. Methodology: Data for patients with BAO treated between November 2013 and December 2021 were evaluated using a database. The association between clinical and procedural parameters and functional outcome was assessed. Results: A total of 89 patients with BAO were identified. Full recanalization was achieved in 69.7% of cases and partial recanalization in 19.1%. Intracranial hemorrhage was detected in 11 (12.4%) patients, of which, eight (9.0%) patients experienced symptomatic intracranial hemorrhage. Patients with good outcomes presented with milder strokes (mean NIHSS score of 12.58 vs. 24.00, p < 0.001), had higher collateral scores (6.79 vs. 5.88, p = 0.016), more often achieved complete recanalization (87.9% vs. 58.9%, p = 0.009), and more often experienced early neurological improvement (66.7% vs. 26.8%, p < 0.001). On the contrary, patients with worse outcomes had higher serum glucose levels (p = 0.05), occlusion of the middle portion of the basilar artery (MAB) (30.3% vs. 53.6%, p = 0.033), longer thrombus lengths (10.51 vs. 16.48 mm, p = 0.046), and intracranial hemorrhage (p = 0.035). Conclusions: The present study results suggest that direct aspiration is a safe and effective treatment for patients with BAO. We identified several factors affecting the patients' outcome.

Transjugular approach in aspiration thrombectomy and angioplasty of a thrombosed straight arteriovenous graft compared to the direct hemodialysis access approach.

PURPOSE: To evaluate the efficacy and outcome of the transjugular approach in endovascular recanalization of a thrombosed straight arteriovenous graft (AVG) compared to those of the direct hemodialysis access approach (conventional approach). MATERIALS AND METHODS: We retrospectively assessed patients who underwent aspiration thrombectomy and percutaneous transluminal angioplasty for thrombosed straight AVG performed at a single institution between October 2006 and October 2021. A total of 138 thrombosed AVGs in 83 patients (39 male and 44 females) were divided into the transjugular approach group (Group A) and the conventional approach group (Group B). Technical and clinical success, postintervention primary patency, cumulative patency, and periprocedural complications were compared. RESULTS: There was no statistical difference in demographic data between groups A and B. The technical success rate of group A and B was 96.4% (80/83) and 98.2% 54/55, respectively (p > 0.05). The mean procedure time was 61.4 min (Group A) and 70.5 min (Group B) (p > 0.05). There was no statistically significant difference between the two groups in postintervention primary patency. The cumulative patency of Groups A and B was 911.9 days (range 122-6277) and 1062.3 days (range 72-2302 days), respectively (p > 0.05). One patient in Group B experienced a major graft rupture. Pseudoaneurysm formation at the sheath insertion site occurred in two patients in Group B. No cases of stenosis or thrombosis of the IJV or hematoma at the puncture site were observed in Group A. CONCLUSION: The transjugular approach is as safe and effective as the conventional approach for aspiration thrombectomy and percutaneous transluminal angioplasty of thrombosed straight AVGs.

Optimizing suction force in mechanical thrombectomy: Priming the aspiration tubing with air versus saline.

Objective: We sought to investigate how priming the tube between air versus air mixed with saline ex vivo influenced suction force. We examined how priming the tube influenced peak suction force and time to achieve peak suction force between both modalities. Methods: Using a Dwyer Instruments (Dwyer Instruments Inc., Michigan City, IN, USA), INC Digitial Pressure Gauge, we were able to connect a .072 inch aspiration catheter to a rotating hemostatic valve and to aspiration tubing. We recorded suction force measured in negative inches of Mercury (inHg) over 10 iterations between having the aspiration tube primed with air alone versus air mixed with saline. A test was used to compare results between both modalities. Results: Priming the tube with air alone compared to air mixed with saline was found to have an increased average max suction force (-28.60 versus -28.20 in HG, p<0.01). We also identified a logarithmic curve of suction force across time in which time to maximal suction force was more prompt with air compared with air mixed with saline (13.8 seconds versus 21.60 seconds, p<0.01). Conclusions: Priming the tube with air compared to air mixed with saline suggests that not only is increased maximal suction force achieved, but also the time required to achieve maximal suction force is less. This data suggests against priming the aspiration tubing with saline and suggests that the first pass aspiration primed with air may have the greatest suction force.

Use of the Indigo CAT RX aspiration system during percutaneous coronary intervention.

BACKGROUND: The use of the Indigo CAT RX Aspiration System (Penumbra Inc.) during percutaneous coronary intervention has received limited study. METHODS: We retrospectively examined the clinical, angiographic, and procedural characteristics, outcomes, and follow-up of patients who underwent mechanical aspiration thrombectomy with the Indigo CAT RX system (Penumbra Inc.) at a large tertiary care hospital between January 2019 and April 2023. RESULTS: During the study period, 83 patients (85 lesions) underwent thrombectomy with the Indigo CAT RX. Mean patient age was 64.9 ± 14.48 years and 31.2% were women. The most common presentations were ST-segment elevation myocardial infarction (MI) (66.2%) and non-ST-segment elevation MI (26.5%). A final thrombolysis in MI flow grade of 3 and final myocardial blush grade of 3 were achieved in 76% and 46% of the cases, respectively. Technical success was achieved in 88.9% of the cases that included Indigo CAT RX treatment only, compared with 57.1% of the cases that also included manual aspiration. There were no device-related serious adverse events. At 30-day postprocedure, the incidence of major adverse cardiac events (composite of cardiovascular death, recurrent MI, cardiogenic shock, new or worsening New York Heart Association Class IV heart failure, stroke) was 8.5%: 1.3% stroke (postprocedure, in-hospital), 1.3% MI, 6.1% cardiac death, and 7.5% developed cardiogenic shock. CONCLUSIONS: Use of the Indigo CAT RX system is associated with high technical success and acceptable risk of complications, including stroke.

A meta-analysis of outcomes of aspiration thrombectomy for high and intermediate-risk pulmonary embolism.

BACKGROUND: Aspiration thrombectomy has gained popularity in patients with massive and sub-massive pulmonary embolism (PE) and having contraindications to thrombolysis. METHODS: A meta-analysis was conducted including studies on aspiration thrombectomy in patients with high-risk and intermediate-risk PE. The pooled odds ratio for efficacy parameters, including change in heart rate, blood pressure and right ventricle/left ventricle (RV/LV) ratio, and safety parameters including major bleeding and stroke, was calculated using a random effects model. RESULTS: The meta-analysis of 24 selected studies revealed that intermediate and high-risk pulmonary embolism (PE) patients demonstrated significant improvements: modified Miller score odds ratio of 10.60, mean pulmonary artery pressure reduction by 0.04 mm Hg, and an overall all-cause mortality odds ratio of 0.10. Considerable heterogeneity was observed in various outcomes. CONCLUSION: Aspiration thrombectomy has success rates in both high-risk and intermediate-risk PE, however, procedural risks, including bleeding, must be anticipated.

Comparative outcomes of catheter-directed thrombolysis versus AngioJet pharmacomechanical catheter-directed thrombolysis for treatment of acute iliofemoral deep vein thrombosis.

OBJECTIVE: The objective of this study was to compare the outcomes of pharmacomechanical thrombolysis and thrombectomy (PCDT) plus catheter-directed thrombolysis (CDT) vs CDT alone for the treatment of acute iliofemoral deep vein thrombosis (DVT) and summarize the clinical experience, safety outcomes, and short- and long-term efficacy. METHODS: We performed a 4-year retrospective, case-control study. A total of 95 consecutive patients with acute symptomatic iliofemoral deep vein thrombosis (DVT) with a symptom duration of ≤7 days involving the iliac and/or common femoral veins underwent endovascular interventions. The patients were divided into two groups according to their clinical indications: PCDT plus CDT vs CDT alone. Statistical analyses were used to compare the clinical characteristics and outcomes between the two groups. Additionally, the patients were followed up for 3 to 36 months after treatment, and the proportions of post-thrombotic syndrome (PTS) and moderate to severe PTS were analyzed using the Kaplan-Meier survival method. RESULTS: A total of 95 consecutive patients were analyzed in this retrospective study, of whom, 51 underwent CDT alone and 44 underwent PCDT plus CDT. Between the two groups, in terms of immediate-term efficacy and safety, significant differences were found in the catheter retention time (60.64 ± 12.04 hours vs 19.42 ± 4.04 hours; P < .001), dosages of urokinase required (5.82 ± 0.81 million units vs 1.80 ± 0.64 million units; P < .001), the detumescence rate at 24 hours postoperatively (48.46% ± 8.62% vs 76.79% ± 7.98%; P = .026), the descent velocity of D-dimer per day (2266.28 ± 1358.26 µg/L/D vs 3842.34 ± 2048.02 µg/L/D; P = .018), total hospitalization stay (6.2 ± 1.40 days vs 3.8 ± 0.70 days; P = .024), number of postoperative angiograms (2.4 ± 0.80 vs 1.2 ± 0.30; P = .042), and grade III venous patency (>95% lysis: 54.5% vs 68.6%; P = .047). Furthermore, during the follow-up period, significant differences were found in the incidence of PTS (Villalta scale ≥5 or a venous ulcer: 47.0% vs 27.7%; P = .037), and the incidence proportion of moderate to severe PTS at 12 months (15.7% vs 4.5%; P = .024) and 24 months (35.3% vs 11.4%; P = .016). CONCLUSIONS: Compared with CDT alone, in the iliofemoral DVT subgroup with a symptom duration of ≤7 days, PCDT plus CDT could significantly relieve early leg symptoms, shorten the hospitalization stay, reduce bleeding complications, promote long-term venous patency, and decrease the occurrence of PTS and the incidence proportion of moderate to severe PTS. Thus, the short- and long-term outcomes both support the superiority of PCDT plus CDT vs CDT in this subgroup.

Safety and efficacy of mechanical aspiration thrombectomy for patients with acute lower extremity ischemia.

OBJECTIVE: Acute limb ischemia (ALI) is associated with high rates of amputation and consequent morbidity and mortality. The objective of this study is to report on the safety and efficacy of aspiration thrombectomy using the Indigo Aspiration System in patients with lower extremity (LE) ALI. METHODS: The STRIDE study was an international, multicenter, prospective, study that enrolled 119 participants presenting with LE-ALI. Patients were treated firstline with mechanical thrombectomy using the Indigo Aspiration System, before stenting or angioplasty, or other therapies as determined by treating physician. The primary end point was target limb salvage at 30 days after the procedure. Secondary end points within 30 days included technical success, defined as core laboratory-adjudicated Thrombolysis in Myocardial Infarction (TIMI) 2/3 flow rate immediately after the procedure, changes in modified Society for Vascular Surgery runoff score, improvement of Rutherford classification compared with before the procedure, patency, rate of device-related serious adverse events, and major periprocedural bleeding. Secondary end points that will be evaluated at 12 months include target limb salvage and mortality. RESULTS: Of the 119 participants enrolled at 16 sites, the mean age was 66.3 years (46.2% female). At baseline (n = 119), ischemic severity was classified as Rutherford I in 10.9%, Rutherford IIa in 54.6%, and Rutherford IIb in 34.5%. The mean target thrombus length was 125.7 ± 124.7 mm. Before the procedure, 93.0% (of patients 107/115) had no flow (TIMI 0) through the target lesion. The target limb salvage rate at 30 days was 98.2% (109/111). The rate of periprocedural major bleed was 4.2% (5/119) and device-related serious adverse events was 0.8% (1/119). Restoration of flow (TIMI 2/3) was achieved in 96.3% of patients (105/109) immediately after the procedure. The median improvement in the modified Society for Vascular Surgery runoff score (before vs after the procedure) was 6.0 (interquartile range, 0.0-11.0). Rutherford classifications also improved after discharge in 86.5% of patients (83/96), as compared with preprocedural scores. Patency at 30 days was achieved in 89.4% of patients (101/113). CONCLUSIONS: In the STRIDE (A Study of Patients with Lower Extremity Acute Limb Ischemia to Remove Thrombus with the Indigo Aspiration System) study, aspiration thrombectomy with the Indigo System provided a safe and effective endovascular treatment for patients with LE-ALI, resulting in a high rate (98.2%) of successful limb salvage at 30 days, with few periprocedural complications.

Aspiration thrombectomy with the Penumbra System for patients with stroke and late onset to treatment: a subset analysis of the COMPLETE registry.

Background: The purpose of this study was to report the safety and performance of aspiration thrombectomy with the Penumbra System for patients with acute ischemic stroke (AIS) due to anterior circulation large vessel occlusion (LVO) and late onset to treatment. Methods: This is a retrospective subset analysis of a global prospective multicenter registry (COMPLETE) that enrolled adults with AIS due to LVO and a pre-stroke modified Rankin Scale score (mRS) of 0 or 1 who were treated first-line with aspiration thrombectomy either alone (A Direct Aspiration First Pass Technique [ADAPT]) or in combination with the 3D Revascularization Device (ADAPT + 3D). This subset analysis included all patients in the registry who had anterior circulation LVO, an Alberta Stroke Program Early CT Score of at least 6, and late onset to treatment (>6 h from stroke onset to puncture). Results: Of the 650 patients in the COMPLETE registry, 167 were included in this subset analysis. The rate of successful revascularization (modified thrombolysis in cerebral infarction score 2b-3 achieved) at the end of the procedure was 83.2%, the rate of good functional outcome (mRS 0-2) at 90 days was 55.4%, and the all-cause mortality rate at 90 days was 14.4%. No device-related serious adverse events (SAEs) occurred. Procedure-related SAEs occurred in 9 patients (5.4%) within 24 h and in 12 patients (7.2%) overall. The rate of successful revascularization was higher for patients treated first-line with ADAPT (88.0%) than for patients treated first-line with ADAPT + 3D (75.0%; p = 0.035); no significant difference was observed between the ADAPT and ADAPT + 3D groups for any other primary or secondary outcome. Conclusion: For patients with AIS due to anterior circulation LVO and with late onset to treatment, aspiration thrombectomy with the Penumbra System appears to be safe and effective. The rates of good functional outcome and all-cause mortality from this study compared favorably with those rates from the medical management arms of the DAWN and DEFUSE-3 studies. Clinical trial registration: https://www.clinicaltrials.gov, NCT03464565.

The Prevalence of Cardiovascular Complications and Causes of AngioJet Failure: A Post-Marketing Surveillance Study Based on the MAUDE (Manufacturer and User Facility Device Experience) Database.

Background and objective Aspiration thrombectomy devices, such as the AngioJet Solent Omni (Boston Scientific Corporation, Marlborough, MA) have been approved by the US FDA for the treatment of thrombi in peripheral arterial disease, venous disease, and AV fistulas. However, there is a dearth of real-world data on the most common modes of failure and complications associated with the AngioJet Solent Omni. In this study, we aimed to address this scarcity of data. Methods The MAUDE (Manufacturer and User Facility Device Experience) database was queried for reports of device failure and adverse events spanning the period from October 2012 to December 2021. Results A total of 499 events were reported during the study period. After the exclusion of duplicate reports, the final analysis included 450 reports. The most common mode of failure was catheter breakage/kinking during suction thrombectomy with 137 reports (30%). The most common vessel associated with events was the superficial femoral artery or vein, which was documented in 82 reports (18.2%). The most common adverse clinical outcome was the embedding of a piece of the device in the patient, which occurred in seven reports (1.6%). There were seven (1.6%) events of death reported during the period studied. Conclusions Based on our findings, theAngioJet Solent Omni device provides promising results; however, it is important to evaluate device safety. It is associated with complications including device embedment, catheter breakage/kinking, and death, and these adverse events are linked to patient characteristics and risk factors.

Penumbra aspiration thrombectomy of the superior mesenteric artery for mesenteric ischemia.

Acute mesenteric ischemia from thromboembolic occlusion is a life-threatening emergency associated with a high mortality rate. Prompt diagnosis and intervention are vital to preserve viable bowel and prevent mortality. In the past decade, a shift has occurred toward minimally invasive alternatives such as endovascular therapies. We present a case of acute mesenteric ischemia from superior mesenteric artery thrombosis treated promptly with the Penumbra suction thrombectomy device (Penumbra Inc).

ST-Segment Elevation: An Unexpected Culprit.

The clinical presentation of pulmonary embolism (PE) and acute coronary syndrome can be similar. We report a case of a patient presenting with antero-septal ST-segment elevation after cardiac arrest, found to have acute-PE-mimicking ST-segment elevation myocardial infarction (STEMI), treated with aspiration thrombectomy and catheter-directed thrombolysis (CDT). A 78-year-old man was admitted with dyspnea, chest pain and tachycardia. During evaluation, cardiac arrest in pulseless electrical activity was documented. Advanced life support was started immediately. ECG post-ROSC revealed ST-segment elevation in V1-V4 and aVR. Echocardiography showed normal left ventricular function but right ventricular (RV) dilation and severe dysfunction. The patient was in shock and was promptly referred to cardiac catheterization that excluded significant CAD. Due to the discordant ECG and echocardiogram findings, acute PE was suspected, and immediate invasive pulmonary angiography revealed bilateral massive pulmonary embolism. Successful aspiration thrombectomy was performed followed by local alteplase infusion. At the end of the procedure, mPAP was reduced and blood pressure normalized allowing withdrawal of vasopressor support. Twenty-four-hour echocardiographic reassessment showed normal-sized cardiac chambers with preserved biventricular systolic function. Bedside echocardiography in patients with ST-segment elevation post-ROSC is instrumental in raising the suspicion of acute PE. In the absence of a culprit coronary lesion, prompt pulmonary angiography should be considered if immediately feasible. In these cases, CDT and aspiration in high-risk acute PE seem safe and effective in relieving obstructive shock and restoring hemodynamics.