RESUMO
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.
RESUMO
Background Aspiration thrombectomy devices, such as the AngioVac, allow the removal of thrombus, especially in patients with contraindications to anticoagulation use. The AngioVac was approved by the U.S. Food and Drug Administration to remove fresh, soft thrombi or emboli during extracorporeal bypass for up to six hours. Real-world data on the most common modes of failure and complications associated with the AngioVac are unavailable. Methods The Manufacturer and User Facility Device Experience database was queried for reports of the AngioVac device failure and adverse events from April 2013 to March 2022. Categorical variables were described as numbers, and all statistical calculations were performed with IBM SPSS Statistics, version 27.0 (IBM Corp., Armonk, NY). Results A total of 115 events were reported during the study period. After the exclusion of duplicate reports, the final cohort included 93 reports. The most common mode of failure for the AngioVac was physical damage of the device, with 13 reports (14%). The most common vessels associated with events were the superior vena cava and inferior vena cava, occurring in 23 reports (24.7%). The most common adverse clinical events were pulmonary embolism (PE), occurring in 33 reports (35.5%), and perforation, occurring in 16 reports (17.2%). Other less frequent adverse outcomes were arrhythmias, stroke, and foreign body device embedment. There were 45 deaths reported with the use of the AngioVac. Conclusions Aspiration thrombectomy devices provide promising efficacy; however, physicians should be aware of known adverse outcomes, even if they are infrequent. Based on this analysis, PE and vessel perforation were the most common adverse outcomes. Furthermore, the most common mode of failure was secondary to physical damage of the device.
RESUMO
Background Orbital atherectomy (OA) is used to prepare severely calcified coronary artery lesions before percutaneous coronary intervention (PCI). Intravascular ultrasound (IVUS) is used to determine the plaque volume and degree of stenosis within the arterial vessel. This study evaluated the safety and efficacy of OA for treating severely calcified coronary lesions and determined if IVUS impacted these outcomes. Methods We retrospectively collected data from a single center of patients with severe coronary artery calcification who underwent OA. The data on baseline characteristics and procedural and clinical outcomes were collected and analyzed. Results A total of 374 patients underwent OA. The mean age was 69 ± 12.7; 53.6% were Black, and 38% were female. Hypertension was present in 96% of the patients, followed by hyperlipidemia in 79.4%, diabetes mellitus in 53.7%, and chronic kidney disease (CKD) in 22.7%. More patients had presented with a non-ST-elevation myocardial infarction (NSTEMI) compared to ST-elevation myocardial infarction (STEMI) at 36.3% versus 4.3%, respectively. The radial artery was used in 35.4% of the cases, and the left anterior descending artery (LAD) was the most commonly treated vessel with OA at 61%, followed by the right coronary artery (RCA) at 30.7%. IVUS was utilized in 63.4% of cases. The most common complication of the procedure was perforation and dissection at an equal proportion of 1.3% among all patients. The no-reflow rate was 0.5%, and 0.5% developed post-procedural myocardial infarction (MI). The average length of stay was 4.7 days, while a marginal proportion, at 10.5%, had same-day discharge with no recorded complications. Conclusion In this analysis of patients with severely calcified coronary lesions, OA had low rates of major adverse cardiovascular events (MACE) and was considered a safe and effective treatment for complex coronary lesions.