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European Heart Journal. Acute... Sep 2023High- (HR) and intermediate-high risk (IHR) pulmonary embolisms (PEs) are related to high early mortality and long-term sequelae. We aimed to describe clinical outcomes...
AIMS
High- (HR) and intermediate-high risk (IHR) pulmonary embolisms (PEs) are related to high early mortality and long-term sequelae. We aimed to describe clinical outcomes and adverse events in IHR and HR pulmonary embolism (PE) treated with catheter-directed mechanical thrombectomy (CDMT) in a real-world population.
METHODS AND RESULTS
This study is a multicenter, prospective registry enrolling 110 PE patients treated with CDMT between 2019 and 2022. The CDMT was performed using the 8F Indigo (Penumbra, Alameda, CA, USA) system bilaterally in pulmonary arteries (PAs). The primary safety endpoints included device or PE-related death during the 48-h after CDMT, procedure-related major bleeding, or other major adverse events. Secondary safety outcomes were all-cause mortality during hospitalization or the follow-up. The primary efficacy outcomes were the reduction of PA pressures and change in the right-to-left ventricular (RV/L) ratio assessed in the imaging 24-48 h after the CDMT.71.8% of patients had IHR PE and 28.2% HR PE. 11.8% of patients had a failure and 34.5% had contraindications to thrombolysis, and 2.7% had polytrauma. There was 0.9% intraprocedural death related to RV failure and 5.5% deaths within the first 48 h. CDMT was complicated by major bleeding in 1.8%, pulmonary artery injury in 1.8%, and ischaemic stroke in 0.9%. Immediate haemodynamic improvements included a 10.4 ± 7.8 mmHg (19.7%) drop in systolic PAP (P < 0.0001), a 6.1 ± 4.2 mmHg (18.8%) drop in mean PAP, and 0.48 ± 0.4 (36%) drop in RV/LV ratio (P < 0.0001).
CONCLUSION
These observational findings suggest that CDMT may improve hemodynamics with an acceptable safety profile in patients with IHR and HR PE.
Topics: Humans; Thrombolytic Therapy; Brain Ischemia; Treatment Outcome; Stroke; Thrombectomy; Pulmonary Embolism; Catheters; Registries; Hemorrhage; Fibrinolytic Agents; Retrospective Studies
PubMed: 37319339
DOI: 10.1093/ehjacc/zuad066 -
Journal of Neurointerventional Surgery Feb 2024WEB Shape Modification (WSM) over time is frequent after aneurysm treatment. In this study, we explored the relationship between histopathological changes and...
BACKGROUND
WEB Shape Modification (WSM) over time is frequent after aneurysm treatment. In this study, we explored the relationship between histopathological changes and angiographic evolution over time in experimental aneurysms in rabbits treated with the Woven EndoBridge (WEB) procedure.
METHODS
Quantitative WSM was assessed using flat-panel computed tomography (FPCT) during follow-up by calculating height and width ratio (HR, WR), defined as the ratio between either measurement at an index time point and the measurement immediately after WEB implantation. The index time point varied from 1 day to 6 months. HR and WR were evaluated with angiographic and histopathological assessments of aneurysm healing.
RESULTS
Final HR of devices varied from 0.30 to 1.02 and final WR varied from 0.62 to 1.59. Altogether, at least 5% of HR and WR variations were observed in 37/40 (92.5%) and 28/40 (70%) WEB devices, respectively, at the time of final assessment. There was no significant correlation between complete or incomplete occlusion groups and HR or WR (p=0.15 and p=0.43). Histopathological analysis revealed a significant association between WR and aneurysm healing and fibrosis 1 month following aneurysm treatment (both p<0.05).
CONCLUSION
Using longitudinal FPCT assessment, we observed that WSM affects both the height and width of the WEB device. No significant association was found between WSM and aneurysm occlusion status. Although presumably a multifactorial phenomenon, the histopathological analysis highlighted a significant association between width variations, aneurysm healing and fibrosis in the first month following aneurysm treatment.
Topics: Animals; Rabbits; Treatment Outcome; Intracranial Aneurysm; Tomography, X-Ray Computed; Cerebral Angiography; Embolization, Therapeutic; Endovascular Procedures; Fibrosis; Retrospective Studies
PubMed: 37192788
DOI: 10.1136/jnis-2023-020193 -
Current Problems in Cardiology Aug 2023Venous thromboembolic disease (VTE) is a health problem; around 10 million cases occur yearly with substantial morbidity and mortality. Those who survive may be left... (Review)
Review
Venous thromboembolic disease (VTE) is a health problem; around 10 million cases occur yearly with substantial morbidity and mortality. Those who survive may be left with long-term sequelae. Those sequelae might include chronic thromboembolic pulmonary hypertension, persistent right ventricular dysfunction, exercise intolerance, and reduced quality of life. Current PE management consists of anticoagulation alone, systemic thrombolysis, catheter-directed thrombolysis, and surgical embolectomy. The severity of patients with pulmonary embolism (PE) depends on the clinic and not exclusively on the extent of radiological or anatomical involvement. In this review, we present the main clinical and functional characteristics of patients in whom thrombotic fragmentation plus catheter-guided thrombolysis is used to manage acute PE of intermediate-high risk and torpid evolution within the first hours of admission.
Topics: Humans; Thrombolytic Therapy; Treatment Outcome; Quality of Life; Pulmonary Embolism; Catheters; Acute Disease; Disease Progression; Fibrinolytic Agents
PubMed: 35395331
DOI: 10.1016/j.cpcardiol.2022.101197 -
Cardiology in the Young Oct 2023Device embolisation is a serious adverse event during transcatheter duct closure. This study analyses risk factors for embolisation.
BACKGROUND
Device embolisation is a serious adverse event during transcatheter duct closure. This study analyses risk factors for embolisation.
METHODS
Demographic parameters, echocardiographic anatomy, haemodynamics, and procedural characteristics of consecutive duct closures in a tertiary centre over 8 years were analysed. Procedures complicated by embolisation were compared to uncomplicated procedures.
RESULTS
Fifteen embolisations occurred during 376 procedures. All except one embolisation were in infants. The pulmonary artery: aortic pressure ratio was 0.78 ± 0.22. Embolisation was seen significantly more commonly in Type C tubular ducts. Vascular plugs were more significantly associated with embolisations. Logistic regression analysis showed device embolisation was significantly higher in age group of < 6 months compared to 6-12 months (p = 0.02), higher in those with tubular ducts versus conical ducts (p = 0.003), use of vascular plugs compared to conventional duct occluders (p = 0.05), and in duct closure with undersized devices (p = 0.001). There was no in-hospital mortality. Three patients needed surgical retrieval while others were successfully managed in catheterisation laboratory.
CONCLUSIONS
Device embolisation complicates 4% of transcatheter duct closures, with need for surgery in one-fifth of them. Larger ducts with high pulmonary artery pressures in younger and smaller infants are more often associated with device embolisation. Tubular ducts are more prone for embolisation compared to usual conical ducts. Softer vascular plugs are often associated with embolisations. Intentional device undersizing to avoid vascular obstruction in small patients is a frequent risk factor for embolisation. Precise echocardiographic measurements, correct occluder choice, proper technique and additional care in patients with high pulmonary artery pressures are mandatory to minimise embolisations.
Topics: Infant; Humans; Ductus Arteriosus, Patent; Treatment Outcome; Cardiac Catheterization; Embolization, Therapeutic; Risk Factors; Septal Occluder Device
PubMed: 36515000
DOI: 10.1017/S1047951122003973 -
Clinical Neuroradiology Dec 2023The recently introduced Pipeline Vantage Embolization Device with Shield Technology is the fourth generation of Pipeline flow diverter devices. Due to the relatively... (Review)
Review
PURPOSE
The recently introduced Pipeline Vantage Embolization Device with Shield Technology is the fourth generation of Pipeline flow diverter devices. Due to the relatively high rate of intraprocedural technical complications, modifications were subsequently made to the device after a limited release of the device in 2020. This study aimed to evaluate the safety and efficacy of the modified version of this device.
METHODS
This was a multicentre retrospective series. The primary efficacy endpoint was aneurysm occlusion in the absence of retreatment. The primary safety endpoint was any neurological morbidity or death. Ruptured and unruptured aneurysms were included in the study.
RESULTS
A total of 52 procedures were performed for 60 target aneurysms. Treatment was performed on 5 patients with ruptured aneurysms. The technical success rate was 98%. The mean clinical follow-up time was 5.5 months. In patients presenting with unruptured aneurysms there were no deaths, 3 (6.4%) major complications and 7 (13%) minor complications. In the five patients presenting with subarachnoid haemorrhage there were 2 (40%) major complications with 1 (20%) of these resulting in death, and 1 (20%) minor complication. Of the patients 29 (56%) had undergone 6‑monthly postprocedural angiographic imaging with a mean time of 6.6 months demonstrating that 83% of patients had achieved adequate occlusion (RROC1/2) of the aneurysm.
CONCLUSIONS
In this non-industry-sponsored study, the occlusion rates and safety outcomes were similar to those seen in previously published studies with flow diverter devices and earlier generation Pipeline devices. Modifications to the device appear to have improved ease of deployment.
Topics: Humans; Treatment Outcome; Retrospective Studies; Intracranial Aneurysm; Embolization, Therapeutic; Cerebral Angiography; Endovascular Procedures; Follow-Up Studies; Stents; Multicenter Studies as Topic
PubMed: 37378843
DOI: 10.1007/s00062-023-01314-x -
Journal of Neurointerventional Surgery Dec 2023The US Woven EndoBridge Intra-saccular Therapy (WEB-IT) study is a pivotal, prospective, single arm, investigational device exemption study to evaluate the safety and...
Safety and effectiveness of the Woven EndoBridge (WEB) system for the treatment of wide necked bifurcation aneurysms: final 5 year results of the pivotal WEB Intra-saccular Therapy study (WEB-IT).
INTRODUCTION
The US Woven EndoBridge Intra-saccular Therapy (WEB-IT) study is a pivotal, prospective, single arm, investigational device exemption study to evaluate the safety and effectiveness of the WEB device for the treatment of wide neck bifurcation aneurysms (WNBAs). We present complete 5 year data for the cohort of 150 patients.
METHODS
150 patients with WNBAs were enrolled at 21 US and six international centers. Imaging from the index procedure, 6 month, 1 year, 3 year, and 5 year follow-up were reviewed by a core laboratory. Adverse events were reviewed and adjudicated by a clinical events adjudicator.
RESULTS
83 patients had 5 year follow-up imaging and 123 had clinical follow-up. No ruptured (0/9) or unruptured aneurysm (0/141) rebled or bled during follow-up. No new device or procedure related adverse events or serious adverse events were reported after 1 year. At 5 years, using the LOCF method, complete occlusion was observed in 58.1% and adequate occlusion in 87.2% of patients. For patients with both 1 year and 5 year occlusion statuses available, 76.8% (63/82) of aneurysms remained stable or improved with no retreatment. After 1 year, 18 aneurysms were retreated, 11 of which were adequately occluded at 1 year, and 15 of which were retreated in the absence of any deterioration in occlusion grade.
CONCLUSIONS
Five year follow-up data from the WEB-IT study demonstrated that the WEB device was safe and effective when used in the treatment of WNBAs. Aneurysm occlusion rates achieved at 1 year follow-up were durable, with rates of progressive thrombosis far exceeding rates of recurrence over time.
Topics: Humans; Treatment Outcome; Intracranial Aneurysm; Prospective Studies; Embolization, Therapeutic; Endovascular Procedures; Retrospective Studies
PubMed: 37355252
DOI: 10.1136/jnis-2023-020611 -
Journal of Neurosurgery Aug 2023The authors compared the Contour Neurovascular System (Contour) with the Woven EndoBridge (WEB) device for the treatment of wide-necked cerebral aneurysms at a...
OBJECTIVE
The authors compared the Contour Neurovascular System (Contour) with the Woven EndoBridge (WEB) device for the treatment of wide-necked cerebral aneurysms at a bifurcation or sidewall.
METHODS
Prospective clinical and radiological data were collected for all patients treated with either the Contour or WEB at a tertiary university hospital from May 2018 to June 2022.
RESULTS
In patients who had at least 3 months of follow-up data available (median patient age 60.0 [IQR 51.8-67.0] years, male/female ratio 1:1.4), the authors compared 40 aneurysms in 34 patients treated with the Contour and 30 aneurysms in 30 patients treated with the WEB. Overall, 26 middle cerebral artery, 24 anterior communicating artery, 9 basilar artery tip, 4 posterior communicating artery, 4 internal carotid artery, 1 anterior cerebral artery, 1 posterior inferior cerebellar artery, and 1 superior cerebellar artery aneurysm were treated. In the Contour cohort, complete occlusion at last follow-up was achieved for 30 aneurysms (75%) and a small neck remnant was seen in 6 aneurysms (15%), summing up to an adequate occlusion rate of 90%. One aneurysm (2.5%) had to be retreated, and 1 symptomatic thromboembolic event (2.5%) was observed with complete remission at discharge. Three adjunctive stents (10%) had to be used due to branch occlusion. In the WEB cohort, adequate occlusion was also seen in 90% of aneurysms (complete occlusion in 19 [63.3%] and remnant neck in 8 [26.7%], with a retreatment rate of 20%). Four WEBs (13.3%) needed additional stent placement due to device protrusion into a branch, 2 asymptomatic thromboembolic events (6.7%) were noted, and 1 major ischemic event (3.3%) due to M2 occlusion was noted. One patient treated with the WEB died between follow-ups of causes unrelated to the aneurysm, treatment, or device. Time from first measurement to deployment and thus total treatment time was significantly shorter in the Contour group (p = 0.004), regardless of whether a prior angiogram was available for aneurysm measurement and device sizing.
CONCLUSIONS
Results for the Contour were promising, although longer follow-up is necessary to draw more solid conclusions on the utility and risk profile of this new device compared with the already widely used WEB device. Adequate occlusion at last follow-up was the same for both devices, whereas the probability of complete occlusion at last follow-up was significantly higher for the Contour, and the WEB showed a significantly higher retreatment rate. Median deployment times were significantly shorter with the Contour than the WEB.
Topics: Humans; Male; Female; Middle Aged; Intracranial Aneurysm; Treatment Outcome; Prospective Studies; Embolization, Therapeutic; Endovascular Procedures; Thromboembolism; Retrospective Studies
PubMed: 36708532
DOI: 10.3171/2022.12.JNS222268 -
Catheterization and Cardiovascular... Nov 2023The use of coils is fundamental in interventional cardiology and can be lifesaving in selected settings. Coils are classified by their materials into bare metal, fiber... (Review)
Review
The use of coils is fundamental in interventional cardiology and can be lifesaving in selected settings. Coils are classified by their materials into bare metal, fiber coated, and hydrogel coated, or by the deliverability method into, pushable or detachable coils. Coils are delivered through microcatheters and the choice of coil size is important to ensure compatibility with the inner diameter of the delivery catheter, firstly to be able to deliver and secondly to prevent the coil from being stuck and damaged. Clinically, coils are used in either acute or in elective setting. The most important acute indication is typically the sealing coronary perforation. In the elective settings, coils can be used for the treatment of certain congenital cardiac abnormalities, aneurysms, fistulas or in the treatment of arterial side branch steal syndrome after CABG. Coils must always be delivered under fluoroscopy guidance. There are some associated complications with coils that can be acute or chronic, that nictitates regular followed-up. There is a need for education, training and regular workshops with hands-on to build the experience to use coils in situations that are infrequently encountered.
Topics: Humans; Treatment Outcome; Cardiac Catheterization; Embolization, Therapeutic; Fluoroscopy; Heart Injuries; Vascular Diseases
PubMed: 37668102
DOI: 10.1002/ccd.30821 -
The Medical Clinics of North America Sep 2023The Centers for Disease Control and Prevention estimates that approximately 900,000 patients are diagnosed with venous thromboembolism (VTE) annually in the United... (Review)
Review
The Centers for Disease Control and Prevention estimates that approximately 900,000 patients are diagnosed with venous thromboembolism (VTE) annually in the United States leading to approximately 548,000 hospitalizations and 100,000 deaths. Approximately 274 people die daily in the United States from VTE. The numbers are staggering with 1 person dying every 5 minutes! There are more deaths annually in the United States from VTE than breast cancer (41,000), AIDS (16,000), and motor vehicle accidents (32,000) combined! VTE is recognized as a leading cause of preventable hospital deaths and a leading cause of maternal deaths.
Topics: Humans; United States; Venous Thromboembolism; Treatment Outcome; Vena Cava Filters; Hospitalization; Pulmonary Embolism
PubMed: 37541714
DOI: 10.1016/j.mcna.2023.05.001 -
Interventional Neuroradiology : Journal... Aug 2023The Woven EndoBridge (WEB) is a potential treatment option in patients with wide-necked bifurcation aneurysms (WNBAs). We analysed our WEB device outcomes (occlusion...
A single centre retrospective analysis of short- and medium-term outcomes using the Woven EndoBridge (WEB) device and identification of the device-to-aneurysm volume ratio as a potential predictor of aneurysm occlusion status.
BACKGROUND
The Woven EndoBridge (WEB) is a potential treatment option in patients with wide-necked bifurcation aneurysms (WNBAs). We analysed our WEB device outcomes (occlusion rates and complications) and studied factors that may predict aneurysm occlusion status at short- and medium-term follow-up.
METHODS
4 patients with ruptured and unruptured aneurysms underwent treatment with the WEB device over a 5-year period. Simple hypothesis tests assessed differences between treated ruptured and unruptured aneurysms. Univariable binary logistic regression was used to assess the effect of age, gender, and aneurysm location on the likelihood of adequate occlusion at six months. Aneurysm dimentions including device-to-aneurysm volume (DAV) ratios were compared between adequately and inadequately occluded aneurysms.
RESULTS
The mean age at the time of the procedure was 58.2 years (SD 12.2; range 34-88) and the male to female ratio was 1:2.7. Middle cerebral artery (MCA) was the most commonly treated aneurysm. There was no significant difference in occlusion rates between ruptured and unruptured aneurysms. The six- and 18-month angiographic follow-up data was available for 61 and 32 patients respectively with adequate occlusion rates of 78.7% (48/61) and 78.1% (25/32). Procedure-related complications occurred in 6 patients (8.1%). Baseline DAV ratio was found to be significantly higher in aneurysms that were adequately occluded at both short- (-value 0.015) and medium-term (-value 0.047) follow-up.
CONCLUSIONS
WEB devices are a safe and effective endovascular treatment option for WNBAs. WEB device selection incorporating the peri-procedural DAV ratio may help improve the accuracy of device sizing thereby improving the successful occlusion rate.
Topics: Humans; Male; Female; Middle Aged; Infant; Intracranial Aneurysm; Retrospective Studies; Embolization, Therapeutic; Endovascular Procedures; Treatment Outcome; Cerebral Angiography
PubMed: 35404152
DOI: 10.1177/15910199221092578