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 the first interim analysis of the STRIKE-PE study, evaluating the safety and effectiveness of computer assisted vaccum thrombectomy (CAVT) for the treatment of acute pulmonary embolism (PE). MATERIALS AND METHODS: This prospective, international, multicenter study will enroll 600 adult patients with acute PE of ≤14 days and a right ventricle (RV)-to-left ventricle (LV) ratio of ≥0.9 who receive first-line endovascular treatment with CAVT using the Indigo Aspiration System (Penumbra, Alameda, California). Primary endpoints are change in RV/LV ratio and incidence of composite major adverse events (MAEs) within 48 hours. Secondary endpoints include functional and quality-of-life (QoL) assessments. RESULTS: The first 150 consecutive patients were treated with 12F catheter 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 70.0 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 to 1.01 at 48 hours, a 25.7% reduction (P < .001). Four (2.7%) patients experienced a composite MAE within 48 hours. At 90-day follow-up, patients exhibited statistically significant improvements in the Borg dyspnea scale score and QoL measures, and the New York Heart Association class distribution returned to that reported before the index PE. CONCLUSIONS: Interim results from the STRIKE-PE study demonstrate a significant reduction in pulmonary artery pressure and RV/LV ratio, a median thrombectomy time of 33.5 minutes, a composite MAE rate of 2.7%, and significant improvements in 90-day functional and QoL outcomes.

Initial experience with a continuous mechanical aspiration system for thrombus removal before percutaneous coronary intervention.

OBJECTIVES: Here we investigate the safety and efficacy of a continuous mechanical aspiration system when used before percutaneous coronary intervention (PCI) in patients with acute coronary syndrome (ACS). BACKGROUND: Historically, trials of routine manual aspiration thrombectomy in ACS patients have reported mixed results. This may be due to the technical limitations of manual aspiration, which suffers from decreasing vacuum power as aspiration is performed. METHODS: This is a retrospective case series of all patients treated with continuous mechanical aspiration (Indigo CAT RX Aspiration System; Penumbra Inc.) before PCI between August 2017 and July 2020 at five centers in the United States. Data regarding angiographic assessments, procedure, and safety were examined. RESULTS: Seventy-two patients (mean age 60 ± 12.5 years, 34.7% female) with ST Elevation Myocardial Infarction (STEMI) (80.6%) or Non-ST Elevation Myocardial Infarction (NSTEMI) (19.4%) were included. Target vessels were the right coronary (43.1%), left anterior descending (33.3%), and left circumflex (23.6%). Preprocedure, 94.4% had a high thrombus burden (thrombolysis in myocardial infarction [TIMI] thrombus grade ≥ 3). Median aspiration time was 35 s and median access-to-reperfusion time was 10 min. After CAT RX alone, 86.1% had complete perfusion (TIMI flow grade 3). After the procedure, 94.4% had TIMI thrombus grade <3% and 97.2% had TIMI flow grade 3. There were no cases of ischemic stroke. Cardiovascular mortality at 30 days was 1.4%. CONCLUSIONS: In our initial experience, aspirating thrombus from ACS patients using the Indigo CAT RX Aspiration System before PCI was safe and effective for reducing thrombus burden and restoring flow.

Contrast medium-induced acute kidney injury: comparison of intravenous and intraarterial administration of iodinated contrast medium.

PURPOSE: To compare the incidence of contrast medium-induced acute kidney injury (AKI) after intravenous (IV) administration of iodixanol for computed tomographic (CT) angiography versus intraarterial (IA) injection of iodixanol or low osmolar contrast medium (LOCM) for digital subtraction angiography (DSA) within the same population suspected of peripheral arterial occlusive disease (PAOD). MATERIALS AND METHODS: CT angiography was performed with IV iodixanol 320 mgI/mL. After a washout period of 3-14 days, DSA was performed with IA iodixanol or LOCM. Serum creatinine was measured at baseline and 24 hours after administration. Contrast medium-induced AKI was defined by a serum creatinine increase of at least 25% versus baseline at 24 hours. Data were analyzed with χ(2) statistics. RESULTS: Mean baseline serum creatinine values were comparable between CT angiography with IV contrast medium and DSA with IA contrast medium (93.3 µmol/L ± 52.92 vs 92.8 µmol/L ± 61.70). The incidence of AKI for CT angiography after IV iodixanol administration was 7.6% (20 of 264), which was not statistically different than the 8.7% incidence (22 of 253) for DSA with IA iodixanol or LOCM (P = .641). In the 143 patients who received only iodixanol for both procedures, incidences of contrast medium-induced AKI were comparable after IV (7.0%) and IA (5.6%) administration (P = .626). CONCLUSIONS: The rates of contrast medium-induced AKI are not statistically different between IV iodixanol for CT angiography and IA iodixanol or another LOCM for DSA in the same population with suspected PAOD.

Contrast-induced acute kidney injury (CI-AKI) following intra-arterial administration of iodinated contrast media.

BACKGROUND: We report the incidence of contrast-induced acute kidney injury (CI-AKI) following administration of iodixanol or low-osmolar contrast media (LOCM) in patients for suspected peripheral arterial occlusive disease (PAOD) undergoing intra-arterial digital angiography (IA-DSA). METHODS: IA-DSA was performed according to site standard for contrast agent type and volume following computed tomography (CT) of the abdominal aortoiliac and lower extremity arteries and a washout period of at least 3 days. Serum creatinine was measured at baseline and 24 ± 4 hours after contrast administration. CI-AKI was defined as laboratory increase of serum creatinine value =25% from baseline measurement at 24 hours. The incidence of CI-AKI was analyzed with chi-square statistics. RESULTS: Of the 250 patients who underwent IA-DSA with complete data for analysis, 147 (58.8%) received iodixanol and 103 (41.2%) received LOCM (iopamidol, 91; ioversol, 7; iohexol, 3; iopromide, 2). Baseline mean serum creatinine was statistically higher for iodixanol compared with LOCM (100 vs. 82.7 µmol/L; p=0.0124). CI-AKI occurred in 8 patients (5.4%) with iodixanol and 14 patients (13.6%) with LOCM (p=0.025). Further analysis showed that iopamidol administration was responsible for the 13 out of 14 cases of CI-AKI in LOCM patients. CONCLUSIONS: In patients with suspected PAOD undergoing IA-DSA, the incidence of CI-AKI at 24 hours following contrast administration was significantly less for patients who received iodixanol compared with various LOCM; this difference was primarily driven by iopamidol.