Six-Month Outcomes of Mechanical Thrombectomy for Treating Deep Vein Thrombosis: Analysis from the 500-Patient CLOUT Registry.

PURPOSE: Mechanical thrombectomy for the treatment of deep vein thrombosis (DVT) is being increasingly utilized to reduce symptoms and prevent postthrombotic syndrome (PTS), but more data on clinical outcomes are needed. Mechanical thrombectomy was studied in the ClotTriever Outcomes (CLOUT) registry with 6-month full analysis outcomes reported herein. MATERIALS AND METHODS: The CLOUT registry is a prospective, all-comer study that enrolled 500 lower extremity DVT patients across 43 US sites treated with mechanical thrombectomy using the ClotTriever System. Core-lab assessed Marder scores and physician-assessed venous patency by duplex ultrasound, PTS assessment using Villalta score, venous symptom severity, pain, and quality of life scores through 6 months were analyzed. Adverse events were identified and independently adjudicated. RESULTS: All-cause mortality at 30 days was 0.9%, and 8.6% of subjects experienced a serious adverse event (SAE) within the first 30 days, 1 of which (0.2%) was device related. SAE rethrombosis/residual thrombus incidence was 4.8% at 30 days and 8.0% at 6 months. Between baseline and 6 months, venous flow increased from 27.2% to 92.5% of limbs (P < 0.0001), and venous compressibility improved from 28.0% to 91.8% (P < 0.0001), while median Villalta scores improved from 9.0 at baseline to 1.0 at 6 months (P < 0.0001). Significant improvements in venous symptom severity, pain, and quality of life were also demonstrated. Outcomes from iliofemoral and isolated femoral-popliteal segments showed similar improvements. CONCLUSION: Outcomes from the CLOUT study, a large prospective registry for DVT, indicate that mechanical thrombectomy is safe and demonstrates significant improvement in symptoms and health status through 6 months. Level of Evidence 3: Non-randomized controlled cohort/follow-up study.

Six-Month Deep Vein Thrombosis Outcomes by Chronicity: Analysis of the Real-World ClotTriever Outcomes Registry.

PURPOSE: To analyze the first 250 patients from the prospective, multicenter, industry-sponsored ClotTriever Outcomes (CLOUT) registry, assessing the safety and effectiveness of mechanical thrombectomy for acute, subacute, and chronic deep vein thrombosis (DVT). MATERIALS AND METHODS: Real-world patients with lower extremity DVT were treated with the ClotTriever System (Inari Medical, Irvine, California). Adjuvant venoplasty, stent placement, or both were performed at the physician's discretion. Thrombus chronicity was determined by visual inspection of removed thrombus, categorizing patients into acute, subacute, and chronic subgroups. Serious adverse events (SAEs) were assessed through 30 days. Clinical and quality-of-life (QoL) outcomes are reported through 6 months. RESULTS: Thrombus chronicity was designated for 244 of the 250 patients (acute, 32.8%; subacute, 34.8%; chronic, 32.4%) encompassing 254 treated limbs. Complete or near-complete (≥75%) thrombus removal was achieved in 90.8%, 81.9%, and 83.8% of the limbs with acute, subacute, and chronic thrombus, respectively. No fibrinolytics were administered, and 243 (99.6%) procedures were single sessions. One (0.4%) patient in the subacute group experienced a device-related SAE, a fatal pulmonary embolism. On comparing baseline and 6-month data, improvements were demonstrated in median Villalta scores (acute, from 10 to 1; subacute, from 9 to 1; chronic, from 10 to 3; for all, P < .0001) and mean EuroQol group 5-dimension (EQ-5D) self-report questionnaire scores (acute, 0.58 to 0.89; subacute, 0.65 to 0.87; chronic, 0.58 to 0.88; for all, P < .0001). There were no significant differences in outcomes across the subgroups. CONCLUSIONS: Mechanical thrombectomy using the ClotTriever System with adjunctive venoplasty and stent placement is safe and similarly effective for acute, subacute, and chronic DVT.

Interim outcomes of mechanical thrombectomy for deep vein thrombosis from the All-Comer CLOUT Registry.

OBJECTIVES: The multicenter, prospective, single arm CLOUT registry assesses the safety and effectiveness of the ClotTriever System (Inari Medical, Irvine, CA) for the treatment of acute and nonacute lower extremity deep vein thrombosis (DVT) in all-comer patients. Reported here are the outcomes of the first 250 patients. METHODS: All-comer patients with lower extremity DVT were enrolled, including those with bilateral DVT, those with previously failed DVT treatment, and regardless of symptom duration. The primary effectiveness end point is complete or near-complete (≥75%) thrombus removal determined by independent core laboratory-adjudicated Marder scores. Safety outcomes include serious adverse events through 30 days and clinical outcomes include post-thrombotic syndrome severity, symptoms, pain, and quality of life through 6 months. RESULTS: The median age was 62 years and 40% of patients had contraindications to thrombolytics. A range of thrombus chronicity (33% acute, 35% subacute, 32% chronic) was observed. No patients received thrombolytics and 99.6% were treated in a single session. The median thrombectomy time was 28 minutes. The primary effectiveness end point was achieved in 86% of limbs. Through 30 days, one device-related serious adverse event occurred. At 6 months, 24% of patients had post-thrombotic syndrome. Significant and sustained improvements were observed in all clinical outcomes, including the Revised Venous Clinical Severity Score, the numeric pain rating scale, and the EuroQol Group 5-Dimension Self-Report Questionnaire. CONCLUSIONS: The 6-month outcomes from the all-comer CLOUT registry with a range of thrombus chronicities demonstrate favorable effectiveness, safety, and sustained clinical improvements.

Percutaneous mechanical thrombectomy in a real-world pulmonary embolism population: Interim results of the FLASH registry.

OBJECTIVES: The FlowTriever All-Comer Registry for Patient Safety and Hemodynamics (FLASH) is a prospective multi-center registry evaluating the safety and effectiveness of percutaneous mechanical thrombectomy for treatment of pulmonary embolism (PE) in a real-world patient population (NCT03761173). This interim analysis reports outcomes for the first 250 patients enrolled in FLASH. BACKGROUND: High- and intermediate-risk PEs are characterized by high mortality rates, frequent readmissions, and long-term sequelae. Mechanical thrombectomy is emerging as a front-line therapy for PE that enables immediate thrombus reduction while avoiding the bleeding risks inherent with thrombolytics. METHODS: The primary endpoint is a composite of major adverse events (MAE) including device-related death, major bleeding, and intraprocedural device- or procedure-related adverse events at 48 h. Secondary endpoints include on-table changes in hemodynamics and longer-term measures including dyspnea, heart rate, and cardiac function. RESULTS: Patients were predominantly intermediate-risk per ESC guidelines (6.8% high-risk, 93.2% intermediate-risk). There were three MAEs (1.2%), all of which were major bleeds that resolved without sequelae, with no device-related injuries, clinical deteriorations, or deaths at 48 h. All-cause mortality was 0.4% at 30 days, with a single death that was unrelated to PE. Significant on-table improvements in hemodynamics were noted, including an average reduction in mean pulmonary artery pressure of 7.1 mmHg (22.2%, p < 0.001). Patient symptoms and cardiac function improved through follow-up. CONCLUSIONS: These interim results provide preliminary evidence of excellent safety in a real-world PE population. Reported outcomes suggest that mechanical thrombectomy can result in immediate hemodynamic improvements, symptom reduction, and cardiac function recovery.

Use of a novel access technology for femoral artery catheterization: results of the RECITAL trial.

OBJECTIVE: To present results of a registry of a novel vascular access device. BACKGROUND: Arterial access has been largely unchanged for 60 years. The Arstasis device creates a novel shallow-angle arterial access designed to facilitate hemostasis without use of a vascular closure device (VCD) or implantation of a foreign body for closure. This is the first publication to report the outcomes of Arstasis access. METHODS: Patients (n = 346) underwent routine diagnostic cardiac catheterization (Dx) at 8 sites in the United States. Patients were assessed for device success, time to hemostasis (TTH), early sit up, time to ambulation (TTA), time-to-discharge-eligibility (TTDe) as well as safety; 249 patients had Dx only, 97 crossed over to PCI. RESULTS: Device deployment was successful in 97%; the other 3% converted to routine access. Mean TTH and TTA for Dx were 4.0 ± 2.5 minutes and 1.5 ± 1.2 hours, respectively; for PCI it was 6.9 ± 5.1 minutes and 3.2 ± 3.3 hours. A subset of 245 patients (72.9%) sat up within 30 minutes after hemostasis; early sit-up was successful in all but 1 (99.6%). TTDe for Dx was 2.7 ± 1.6 hours. There were no major access-site related complications; minor complications were primarily subclinical hematomas in 1.2%. CONCLUSIONS: Arstasis access is associated with short TTH and TTA, early sit up after sheath pull, and accelerated TTDe, achieved without use of VCDs or implantation of a foreign body, with high success and minimal complication rates.

Targeted renal therapy and contrast-induced nephropathy during endovascular abdominal aortic aneurysm repair: results of a feasibility pilot trial.

PURPOSE: To evaluate the feasibility of targeted renal therapy (TRT) to decrease the rate of contrast-induced nephropathy (CIN) during endovascular aortic aneurysm repair (EVAR) in patients at risk for CIN. METHODS: A prospective nonrandomized analysis of TRT was performed in 10 high-risk patients (8 men; median age 66.5 years, range 56-80) with pre-existing renal insufficiency. TRT involved high-dose intrarenal artery infusions of fenoldopam (FEN), a short acting selective dopamine-1 agonist and renal arteriolar vasodilator, delivered percutaneously via a left brachial access using the 5-F Benephit PV Infusion System during EVAR. RESULTS: There were no device-related complications. TRT infusion duration ranged from 3.5 to 6.0 hours (median 4.5). Median contrast dosage was 120 mL (range 50-200). At 24 and 72 hours after EVAR, creatinine clearance (CrCl) had improved in 7 (70%) patients, remained unchanged in 2 (20%), and declined >25% in 1 (10%); the latter returned to baseline on day 5. At 30 days, 7 (70%) patients had improved CrCl and 3 (30%) remained unchanged. CONCLUSION: TRT is feasible during EVAR in high-risk patients. Further investigation is warranted to determine the safety and efficacy of TRT in preserving renal function during EVAR.

A review of the early experience with Targeted Renal Therapy for renal function preservation during endovascular and surgical treatments for cardiovascular disease.

Multiple reports describe the high clinical morbidity and mortality associated with contrast-induced nephropathy (CIN). Similarly, reports have described the glomerular filtration rate (GFR) and worsening renal function as predictors of adverse short and long-term outcomes in several large cardiovascular patient populations including acute myocardial infarction, congestive heart failure, coronary artery bypass surgery (CABG), and endovascular aneurysm repair (EVAR). Targeted renal therapy (TRT) is a novel emerging treatment where high-dose fenoldopam (FEN), a selective renal dopamine-1 receptor agonist and renal arteriolar vasodilator, is infused into both renal arteries via the US FDA-approved 5 Fr bifurcated Benephit PV Catheter Infusion System. TRT has been shown to significantly increase the GFR by 25% vs. placebo and IV-FEN (p < 0.001), which may have important clinical implications in CIN prophylaxis and during surgical procedures including CABG. The aim of this report is to review the early clinical experience and pilot trials with TRT in several clinical scenarios at high-risk for CIN or worsening renal function including percutaneous peripheral vascular interventions (PPI), percutaneous coronary interventions (PCI), CABG and EVAR.