Acute outcomes for the full US cohort of the FLASH mechanical thrombectomy registry in pulmonary embolism.

BACKGROUND: Evidence supporting interventional pulmonary embolism (PE) treatment is needed. AIMS: We aimed to evaluate the acute safety and effectiveness of mechanical thrombectomy for intermediate- and high-risk PE in a large real-world population. METHODS: FLASH is a multicentre, prospective registry enrolling up to 1,000 US and European PE patients treated with mechanical thrombectomy using the FlowTriever System. The primary safety endpoint is a major adverse event composite including device-related death and major bleeding at 48 hours, and intraprocedural adverse events. Acute mortality and 48-hour outcomes are reported. Multivariate regression analysed characteristics associated with pulmonary artery pressure and dyspnoea improvement. RESULTS: Among 800 patients in the full US cohort, 76.7% had intermediate-high risk PE, 7.9% had high-risk PE, and 32.1% had thrombolytic contraindications. Major adverse events occurred in 1.8% of patients. All-cause mortality was 0.3% at 48-hour follow-up and 0.8% at 30-day follow-up, with no device-related deaths. Immediate haemodynamic improvements included a 7.6 mmHg mean drop in mean pulmonary artery pressure (-23.0%; p<0.0001) and a 0.3 L/min/m2 mean increase in cardiac index (18.9%; p<0.0001) in patients with depressed baseline values. Most patients (62.6%) had no overnight intensive care unit stay post-procedure. At 48 hours, the echocardiographic right ventricle/left ventricle ratio decreased from 1.23±0.36 to 0.98±0.31 (p<0.0001 for paired values) and patients with severe dyspnoea decreased from 66.5% to 15.6% (p<0.0001).  Conclusions: Mechanical thrombectomy with the FlowTriever System demonstrates a favourable safety profile, improvements in haemodynamics and functional outcomes, and low 30-day mortality for intermediate- and high-risk PE.

Outcome and technical evolution of type 2 endoleak embolization with ethylene-vinyl-alcohol copolymer.

PURPOSE: This study aims to evaluate the safety and efficacy of novel approaches to type 2 endoleak access for the purpose of embolization using ethylene-vinyl-alcohol copolymer (EVOH) in patients with abdominal aortic aneurysm (AAA) sac expansion post endovascular abdominal aortic repair (EVAR). METHODS: A retrospective review of 43 consecutive patients (mean age = 80.2 ± 6.7 years) who underwent 52 embolization procedures for type 2 endoleaks using EVOH was performed at a single institution. Catheterization of the endoleaks was achieved using the transarterial (TA) and direct translumbar approaches (DTL), in addition to the novel direct transabdominal (DTA) and perigraft (PG) approaches. Endpoints included technical success of endoleak catheterization, technical success of endoleak embolization, endoleak persistence, endoleak recurrence, AAA sac area change, and adverse events. RESULTS: The TA, DTL, DTA, and PG approaches were used 25, 2, 14, and 19 times respectively, including nine procedures where a combination of approaches was used. The technical success rate of endoleak embolization was 98%. Five patients developed recurrent type 2 endoleaks, while five patients developed a type 1 endoleak. The persistent endoleak rate at a mean initial follow-up of 3 months was 34%. At a mean follow-up of 18 months, 58% of patients demonstrated absence of an endoleak, and 71% showed freedom from AAA sac enlargement. No major adverse events were recorded. CONCLUSION: The DTA and PG approaches were safe and effective in this cohort of patients undergoing embolization of type 2 endoleaks with EVOH.

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.

Temporal Analysis of Tachycardia During Catheter Directed Thrombolysis for Acute Pulmonary Embolism.

PURPOSE: To evaluate the effect of catheter directed thrombolysis (CDT) on heart rate (HR) in patients with sinus tachycardia and acute pulmonary embolism (PE). METHODS: A retrospective chart review was performed for patients who underwent CDT with tPA for acute massive or submassive PE between 12/2009 and 2/2020. Included were patients who presented with tachycardia at the time of initiation of CDT. Patients with chronic PE, atrial fibrillation, beta blocker therapy, adjunctive endovascular therapy, systemic thrombolysis, or who expired before conclusion of CDT were excluded. HR was measured approximately every hour during CDT. Graphs were plotted of HR as a function of CDT duration. Two interventional radiologists identified the point of plateau (POP) on the graph where CDT had maximized its benefit in decreasing the patient's HR. Discrepancies were adjudicated by a third interventional radiologist and the median of the 3 measurements was selected. The primary endpoint was the duration of CDT from initiation until the POP. RESULTS: 48 patients were included (52.5 ± 14.7 years, 56.3% female). The POP occurred after 13.1 ± 6.1 hours, by which point HR had been reduced from 110 ± 9.2 bpm to 88 ± 10.6 bpm. Sinus tachycardia was not resolved in 10 patients even though they achieved maximal improvement in HR after 11.3 ± 6.7 hours. CONCLUSION: Patients presenting with sinus tachycardia related to acute PE achieved maximal, sustained reduction in heart rate from CDT, after approximately 13 hours of infusion. Patients who did not resolve their tachycardia by that point in time were unlikely to resolve it by the conclusion of CDT.

The Protégé Nitinol Self-Expanding Stent for the Treatment of Iliofemoral Veno-Occlusive Disease.

PURPOSE: To evaluate the safety and effectiveness of the Protégé nitinol self-expanding stent for the treatment of iliofemoral veno-occlusive disease. MATERIALS AND METHODS: A retrospective review was performed of 376 (284 left, 92 right) Protégé stents in 212 limbs of 183 patients (mean age: 53 ± 17 years, 52% female) treated for iliofemoral veno-occlusive disease between 2011 and 2018. Binary patency was assessed with duplex ultrasound and calculated by Kaplan Meier analysis. Clinical outcomes were evaluated by clinical-etiology-anatomy-pathophysiology (CEAP) classification and Villalta scores. Adverse events were recorded and categorized per Society of Interventional Radiology reporting standards. RESULTS: Of the 212 limbs, 125 presented with acute thrombosis and 28 with chronic thrombosis requiring thrombectomy (n = 44), catheter directed thrombolysis (n = 32), or both (n = 77). Fifty-nine limbs were non-thrombotic. Mean follow-up time was 11.44 ± 11.37 months. Kaplan Meier analysis revealed a primary limb-level patency of 92.3%, 88.6%, 86.9% and 86.9% at 6, 12, 24 and 36 months, respectively. CEAP and Villalta scores improved from a median of C3 (range: 0-6) to C1 (0-5) (p < 0.001) and from a mean of 13.4 ± 7.5 to 5.3 ± 4.9 (p < 0.001), respectively. Nine minor and 2 major adverse events were recorded. CONCLUSIONS: Endovascular treatment of iliofemoral veno-occlusive disease with the Protégé self-expanding stent appears to have good mid-term patency. LEVEL OF EVIDENCE: Level 4, Case Series.

Indigo Aspiration System for Treatment of Pulmonary Embolism: Results of the EXTRACT-PE Trial.

OBJECTIVES: This study sought to prospectively evaluate the safety and efficacy of the Indigo aspiration system in submassive acute pulmonary embolism (PE). BACKGROUND: PE treatment with thrombolytics has bleeding risks. Aspiration thrombectomy can remove thrombus without thrombolytics, but data are lacking. METHODS: This study was a prospective, single-arm, multicenter study that enrolled patients with symptomatic acute PE ≤14 days, systolic blood pressure ≥90 mm Hg, and right ventricular-to-left ventricular (RV/LV) ratio >0.9. The primary efficacy endpoint was change in RV/LV ratio from baseline to 48 h post-procedure on core lab-adjudicated computed tomography angiography. The primary safety endpoint was a composite of 48-h major adverse events: device-related death, major bleeding, and device-related serious adverse events (clinical deterioration, pulmonary vascular, or cardiac injury). All sites received Institutional Review Board approval. RESULTS: A total of 119 patients (mean age 59.8 ± 15.0 years) were enrolled at 22 U.S. sites between November 2017 and March 2019. Median device insertion to removal time was 37.0 (interquartile range: 23.5 to 60.0) min. Two (1.7%) patients received intraprocedural thrombolytics. Mean RV/LV ratio reduction from baseline to 48 h post-procedure was 0.43 (95% confidence interval: 0.38 to 0.47; p < 0.0001). Two (1.7%) patients experienced 3 major adverse events. Rates of cardiac injury, pulmonary vascular injury, clinical deterioration, major bleeding, and device-related death at 48 h were 0%, 1.7%, 1.7%, 1.7%, and 0.8%, respectively. CONCLUSIONS: In this prospective, multicenter study the Indigo aspiration system was associated with a significant reduction in the RV/LV ratio and a low major adverse event rate in submassive PE patients. Intraprocedural thrombolytic drugs were avoided in 98.3% of patients. (Evaluating the Safety and Efficacy of the Indigo aspiration system in Acute Pulmonary Embolism [EXTRACT-PE]; NCT03218566).

Evaluation of the Benefit of Extended Catheter-Directed Thrombolysis with Serial Angiography for Acute Pulmonary Embolism.

PURPOSE: To evaluate whether extended catheter-directed thrombolysis (CDT) with repeat visits to the angiography suite provide added benefit in treatment of acute pulmonary embolism (PE). MATERIALS AND METHODS: This was a retrospective review of CDT procedures performed for acute PE in 156 patients (age 56.1 y ± 15.3, 46.2% women) between 2009 and 2019. All patients underwent at least 1 follow-up visit to the angiography suite for evaluation of pulmonary artery pressure (PAP) and thrombus burden (Miller score) before termination (111/156, 71.2%) or continuation of CDT (45/156, 28.8%). RESULTS: Patients who had CDT extended beyond the first follow-up visit required a higher total dose of tissue plasminogen activator (40.7 mg ± 14.3 vs 22.6 mg ± 9.9, P < .001) to achieve a similar final Miller score (6.4 ± 3.8 vs 7.6 ± 3.9, P = .1) and a similar reduction in systolic PAP (-14.4 mm Hg ± 10.2 vs -12.6 mm Hg ± 11.9, P = .6). The initial Miller scores were similar in both groups (19.7 ± 5.8 vs 19 ± 4, P = .4) but were significantly higher during the first follow-up visit (after 18 hours ± 5.5 vs 20 hours ± 4.8, P = .06) in patients requiring multiple follow-up visits (12.2 ± 5 vs 7.6 ± 3.9, P < .001). Multiple regression analyses identified heart rate > 100 beats/min and systolic PAP > 55 mm Hg as associated with the need for extended CDT. Extended CDT did not result in a higher hemorrhagic complication rate (1/45 vs 6/111, P = .7). CONCLUSIONS: Patients presenting with higher heart rates and systolic PAP may benefit from extended CDT to achieve similar reductions in PAP and thrombus burden, without clear added risk of hemorrhage.

Large-Bore Aspiration Thrombectomy versus Catheter-Directed Thrombolysis for Acute Pulmonary Embolism: A Propensity Score-Matched Comparison.

PURPOSE: To compare effectiveness and safety of large-bore aspiration thrombectomy (LBAT) with catheter-directed thrombolysis (CDT) for treatment of acute massive and submassive pulmonary embolism (PE). MATERIALS AND METHODS: This retrospective review included patients with acute PE treated with LBAT or CDT using tissue plasminogen activator (tPA) between December 2009 and May 2020. A propensity score based on Pulmonary Embolism Severity Index class and PE severity (massive vs submassive) was calculated, and 26 LBAT cases (age 60.2 y ± 17.1, 14/26 women) were matched with 26 CDT cases (age 59.7 y ± 14.2, 14/26 women). RESULTS: The CDT group had 22.1 mg ± 8.1 tPA infused over 21.2 h ± 6.6. Both groups demonstrated similar initial and final systolic pulmonary artery pressure (PAP) (LBAT: 54.5 mm Hg ± 12.9 vs CDT: 54.5 mm Hg ± 16.3, P = .8, and LBAT: 42.5 mm Hg ± 14.1 vs CDT: 42.6 mm Hg ± 12.1, P = .8, respectively) and similar reductions in heart rate (LBAT: -5.4 beats/min ± 19.2 vs CDT: -9.6 beats/min ± 15.8, P = .4). CDT demonstrated a higher reduction in Miller score (-10.1 ± 3.9 vs -7.5 ± 3.8, P = .02). LBAT resulted in 1 minor hemorrhagic complication and 2 procedure-related mortalities, and CDT resulted in 1 minor and 1 major hemorrhagic complication. CONCLUSIONS: LBAT and CDT resulted in similar reductions of PAP and heart rate when used to treat acute PE. CDT reduced thrombus burden to a greater degree. Although hemorrhagic complications rates were not significantly different, the LBAT group demonstrated a higher rate of procedure-related mortality. Larger studies are needed to compare the safety of these techniques.

Evaluation of the Effect of Routine Antibiotic Administration after Uterine Artery Embolization on Infection Rates.

PURPOSE: To evaluate the effect of routine administration of post-procedural antibiotics following elective uterine artery embolization (UAE) on infectious complication rates. MATERIALS AND METHODS: The charts of patients who underwent UAE between January 2013 and September 2019 were retrospectively reviewed. Prior to January 15, 2016, all patients received post-procedural antibiotics with 500 mg of ciprofloxacin twice a day orally for 5 days. After January 15, 2016, none of the patients received post-procedural antibiotics. All patients in both groups received pre-procedural intravenous antibiotics. The post-procedural antibiotics group included 217 patients (age, 44.7 ± 6 years); the no-antibiotics group included 158 patients (age, 45.4 ± 5.6 years). Patients in the no-antibiotics group had a significantly higher rate of diabetes mellitus (P = .03) but fewer cases of adenomyosis (P = .048). Otherwise, demographic and fibroid characteristics were similar between the groups. RESULTS: Six infectious complications (6/375, 1.6%) were recorded. No statistically significant difference (P = .66) was observed in the number of infections between the post-procedural antibiotics group (4/217, 1.8%) and the no-antibiotics group (2/158, 1.3%). Three of the 6 infectious complications presented with malodorous vaginal discharge (3/375, 0.8%) and received nominal therapy. The 3 remaining complications (0.8%) were considered major and included 2 patients (0.5%) who underwent hysterectomy and 1 patient (0.3%) who underwent myomectomy. The major infection rate was 0.9% (2/217) in the post-procedural antibiotics group and 0.7% (1/158) in the no-antibiotics group (P = 1). There were no 90-day post-procedural mortalities. CONCLUSIONS: Discontinuation of routine post-procedural antibiotics with ciprofloxacin after elective UAE did not result in increased rates of infectious complications within the first 90 days post procedure.

Evaluation of Fibrinogen Levels during Catheter-Directed Thrombolysis for Acute Pulmonary Embolism.

PURPOSE: To evaluate the effect of catheter-directed thrombolysis (CDT) with tissue plasminogen activator (tPA) on plasma fibrinogen levels (PFLs) in the setting of acute pulmonary embolism (PE) and the relationship between PFL and hemorrhagic complications. MATERIALS AND METHODS: A retrospective review of CDT procedures between 2009 and 2019 identified 147 CDT procedures for massive or submassive PE (55.8% males; age, 56.5 ± 14.8 years; 90.5% submassive). All patients received therapeutic anticoagulation during CDT with unfractionated heparin (UFH) (69.4%) or low-molecular-weight heparin (LMWH, 30.6%) infusion. CDT was performed with ultrasound-accelerated thrombolysis (USAT) catheters (n = 98), conventional catheter-directed thrombolysis (CCDT) catheters (n = 34), or a combination of both (n = 15). RESULTS: There was a decrease (P = .007) of 15.1 ± 69.4 mg/dl from the initial PFL (376.1 ± 122.7 mg/dl) to the final PFL (361 ± 118.7 mg/dl), which was measured after a mean of 24.1 ± 11.7 hours with a mean tPA dose of 28.3 ± 14.2 mg. The fibrinogen nadir was 327.6 ± 107.1 mg/dl measured 13.4 ± 10.3 hours after initiation of thrombolysis. Of patients with hemorrhagic complications (n = 6), initial, final, and nadir PFL were not significantly lower (P = .053, P = .081, and P = .086, respectively) than the remainder of the cohort. No significant difference was noted in initial and final PFL between the LMWH and UFH groups (P = .2 and P = .1, respectively) or between the CCDT and USAT groups (P = .5 and P = .9, respectively). The UFH group had a lower nadir PFL than the LMWH group (P = .03). CONCLUSIONS: Despite a significant drop in PFL during CDT for acute PE, this was not associated with hemorrhagic complications. These findings were not affected by the choice of anticoagulant or catheter delivery system.

Safety of Therapeutic Anticoagulation with Low-Molecular-Weight Heparin or Unfractionated Heparin Infusion during Catheter-Directed Thrombolysis for Acute Pulmonary Embolism.

PURPOSE: To examine the safety of therapeutic-dose anticoagulation during catheter-directed thrombolysis (CDT) for acute pulmonary embolism (PE). MATERIALS AND METHODS: A retrospective review of 156 consecutive cases (age, 56.6 ± 15.4 years; 85 males) of CDT with alteplase for acute PE (symptoms, <14 days) between 2009 and 2019 was performed. All patients received full-dose anticoagulation before, during, and after thrombolysis with low-molecular-weight heparin (LMWH) (n = 45) or unfractionated heparin (n = 111) infusion. Massive PE was diagnosed in 21 of 156 patients at presentation; submassive PE was diagnosed in 135 of 156 patients at presentation. The Simplified Pulmonary Embolism Severity Index was ≥1 in 69 of 156 patients. RESULTS: There were 4 mild (2.6%), 3 moderate (1.9%), and 3 severe (1.9%) hemorrhagic complications (Global Use of Strategies to Open Occluded Arteries), 1 of which (0.6%) was intracranial. No significant differences in hemorrhagic complication rates (P = .3, P = 1.0, and P = .6, respectively) or general complication rates (Society of Interventional Radiology [SIR] minor, P = .2; SIR major, P = .7) were noted between the LMWH and heparin groups. Mean pulmonary arterial pressure for the entire cohort improved from 28.9 ± 7.6 mmHg to 20.4 ± 6.5 mmHg (P < .001), whereas the Miller score improved from 19.3 ± 4.6 to 7.3 ± 3.9 (P < .001). The average infusion duration was 26 ± 11.9 hours over 2.3 ± 0.6 total visits to the angiography lab, during which a mean of 27.85 ± 14.2 mg of tissue plasminogen activator were infused. CONCLUSIONS: Therapeutic anticoagulation during CDT for PE appears to be safe. The current study did not find a significant difference between LMWH and heparin infusion with respect to hemorrhagic and general complication rates.

Pharmacomechanical Catheter-Directed Thrombolysis in Acute Femoral-Popliteal Deep Vein Thrombosis: Analysis from a Stratified Randomized Trial.

BACKGROUND AND OBJECTIVES: The Acute Venous Thrombosis: Thrombus Removal with Adjunctive Catheter-Directed Thrombolysis (ATTRACT) trial reported that pharmacomechanical catheter-directed thrombolysis (PCDT) did not reduce post-thrombotic syndrome (PTS), but reduced moderate-to-severe PTS and the severity of PTS symptoms. In this analysis, we examine the effect of PCDT in patients with femoral-popliteal deep vein thrombosis (DVT) (without involvement of more proximal veins). PATIENTS AND METHODS: Within the ATTRACT trial, 300 patients had DVT involving the femoral vein without involvement of the common femoral or iliac veins and were randomized to receive PCDT with anticoagulation or anticoagulation alone (no PCDT). Patients were followed for 24 months. RESULTS: From 6 to 24 months, between the PCDT versus no PCDT arms, there was: no difference in any PTS (Villalta scale ≥ 5: risk ratio [RR] = 0.97; 95% confidence interval [CI], 0.75-1.24); moderate-or-severe PTS (Villalta scale ≥ 10: RR = 0.93; 95% CI, 0.57-1.52); severity of PTS scores; or general or disease-specific quality of life (p > 0.5 for all comparisons). From baseline to both 10 and 30 days, there was no difference in improvement of leg pain or swelling between treatment arms. From baseline to 10 days, major bleeding occurred in three versus none (p = 0.06) and any bleeding occurred in eight versus two (p = 0.032) PCDT versus no PCDT patients. Over 24 months, recurrent venous thromboembolism occurred in 16 PCDT and 12 no PCDT patients (p = 0.24). CONCLUSION: In patients with femoral-popliteal DVT, PCDT did not improve short- or long-term efficacy outcomes, but it increased bleeding. Therefore, PCDT should not be used as initial treatment of femoral-popliteal DVT. (NCT00790335).

Tips for pedal access: technical evolution and review.

Pedal access has become an indispensable technique for endovascular therapy of complex lower extremity peripheral vascular disease. From an option as a single access in a patient lacking traditional access approaches to a critical maneuver in combined antegrade-retrograde approaches during the treatment of complex chronic total occlusions, pedal access is an essential tool for any endovascular physician treating peripheral arterial disease. Anticipatory planning is critical in the successful utilization of pedal access. The appropriate tibiopedal vessel should be chosen and combined with the ideal access technique. Knowledge of the current medical devices available for pedal access and post-procedural hemostasis is key and can ease the learning curve. We present the evolution of pedal access with a review of the literature and technical tips to incorporate into everyday practice.

Comparison of Ultrasound-Accelerated versus Pigtail Catheter-Directed Thrombolysis for the Treatment of Acute Massive and Submassive Pulmonary Embolism.

PURPOSE: To compare the technical and clinical effectiveness of ultrasound-accelerated endovascular thrombolysis (USAT) versus pigtail catheter-directed thrombolysis (PCDT) for the treatment of acute pulmonary embolism (PE). MATERIALS AND METHODS: A single-center retrospective study of patients treated with USAT or PCDT for acute massive or submassive PE between January 2010 and December 2016 was performed by reviewing electronic medical records. Sixty treatments were reviewed (mean patient age, 56.7 y ± 14.6), including 52 cases of submassive PE (21 treated with USAT, 31 with PCDT) and 8 cases of massive PE (3 treated with USAT, 5 with PCDT). Endpoints included pulmonary artery pressure (PAP), Miller PE severity index, tissue plasminogen activator (TPA) dose, infusion duration, procedural variables, and complications. RESULTS: Demographics, PE severity, and right:left ventricular diameter ratios were similar between groups. USAT and PCDT significantly reduced mean PAP (reductions of 7.4 mm Hg [P = .002] and 8.2 mm Hg [P < .001], respectively) and Miller index scores (reductions of 45.8% [P < .001] and 53% [P < .001], respectively) with similar effectiveness (P = .47 and P = .15, respectively). Procedure (P < .001) and fluoroscopy (P = .001) times were significantly longer in the USAT group. The USAT group underwent fewer sessions (2.2 ± 0.6 vs 2.4 ± 0.6; P = .17) with shorter infusion times (23.9 h ± 8.8 vs 30.4 h ± 12.6; P = .065) and a lower total dose of TPA (27.1 mg ± 11.3 vs 30.4 mg ± 12.6; P = .075) compared with the PCDT group, but the differences were not significant. Complications (P = .07) and 30-day mortality rates (P = .56) were not significantly different between groups. CONCLUSIONS: USAT and PCDT demonstrated comparable effectiveness and safety in the treatment of patients with acute PE.

Transcatheter Embolization of Type I Endoleaks Associated With Endovascular Abdominal Aortic Aneurysm Repair Using Ethylene Vinyl Alcohol Copolymer.

PURPOSE: To evaluate the feasibility, safety, and outcome of transcatheter embolization using ethylene vinyl alcohol copolymer (EVOH) of type I endoleaks associated with endovascular abdominal aortic aneurysm repair. PATIENT POPULATION AND METHODS: Retrospective chart review was performed to identify 8 consecutive patients who had undergone EVOH embolization for type I endoleaks between 2012 and 2015. The primary approach used to access the endoleak was the perigraft technique, where the endoleak itself is catheterized at the anastomotic site. RESULTS: Six type Ia and 2 type Ib endoleaks were treated. In 2 patients, a direct transabdominal approach was used to access the endoleak because it was inaccessible via the perigraft approach. Coils were used in addition to EVOH in 5 cases. Residual endoleak was noted in 1 case, whereas 2 patients developed a recurrent type I endoleak during follow-up. No EVOH complications were observed. The 5 remaining patients demonstrated freedom from endoleak and reintervention at a mean follow-up of 6.9 months. CONCLUSION: Type I endoleaks can be safely and effectively treated by embolotherapy with EVOH. Larger endoleaks resulting from grossly undersized endografts appear to be unsuitable for EVOH embolization.

Rheolytic Pharmacomechanical Thrombectomy for the Management of Acute Limb Ischemia: Results From the PEARL Registry.

PURPOSE: To present the results of rheolytic pharmacomechanical thrombectomy (PMT) for the management of acute limb ischemia (ALI) as reported in the PEARL Registry (PEripheral Use of AngioJet Rheolytic Thrombectomy with a variety of catheter Lengths). METHODS: A total of 283 patients (mean age 65±13 years; 170 men) presenting with ALI undergoing treatment with the AngioJet System at participating institutions were enrolled in the registry. Rutherford ALI categories included 26% with viable limbs, 38% with marginally threatened limbs, 35% with immediately threatened limbs, and <1% with irreversible damage. Procedure and follow-up data were collected for the calculation of outcomes. To control for patient selection bias, propensity score matching was used to compare outcomes for patients undergoing PMT with or without catheter-directed thrombolysis (CDT). RESULTS: Procedure success was achieved in 235 (83%) of 283 patients. Half of the procedures (147, 52%) were completed without the need for adjunctive CDT. At 12-month follow-up, amputation-free survival and freedom from mortality were 81% and 91%, respectively; 12-month freedom from bleeding requiring transfusion was 91%, and freedom from renal failure was 95%. Subgroup analysis revealed significantly better outcomes in patients without infrapopliteal involvement and those who underwent PMT without CDT. In the matched cohorts, higher rates of procedure success, 12-month amputation-free survival, and 12-month freedom from amputation were observed in the PMT without CDT group (88% vs 74%, p=0.021; 87% vs 72%, p=0.028; 96% vs 81%, p=0.01, respectively). CONCLUSIONS: The results support the use of PMT as a first-line treatment for ALI, providing a rapid reperfusion to the extremity, reduced procedure time, and an acceptable risk profile without compromising limb salvage.

Endovascular Management of Deep Vein Thrombosis with Rheolytic Thrombectomy: Final Report of the Prospective Multicenter PEARL (Peripheral Use of AngioJet Rheolytic Thrombectomy with a Variety of Catheter Lengths) Registry.

PURPOSE: To report procedural and patient outcomes of endovascular treatment for lower-extremity deep vein thrombosis (DVT) with rheolytic thrombectomy (RT). MATERIALS AND METHODS: A total of 32 sites in the United States and Europe enrolled patients with DVT in the Peripheral Use of AngioJet Rheolytic Thrombectomy with a Variety of Catheter Lengths (PEARL) registry. Patient characteristics and outcomes data were collected from consenting patients who underwent rheolytic AngioJet thrombectomy at investigative sites from January 2007 through June 2013. Three hundred twenty-nine patients were enrolled, with 67% of patients undergoing an AngioJet procedure within 14 days of the onset of symptoms. RESULTS: Four treatment approaches using AngioJet thrombectomy were identified: RT without lytic agent in 4% of patients (13 of 329), pharmacomechanical catheter-directed thrombolysis (PCDT) in 35% (115 of 329), PCDT and catheter-directed thrombolysis (CDT) in 52% (172 of 329), and RT in combination with CDT in 9% (29 of 329). Median procedure times for RT alone, PCDT, PCDT/CDT, and RT/CDT were 1.4, 2, 22, and 41 hours, respectively (P < .05, Kruskal-Wallis test). Procedures were completed in less than 24 hours for 73% of patients, with 36% of procedures completed within 6 hours; 86% of procedures required no more than 2 catheter laboratory sessions. The 3-, 6-, and 12-month freedom from rethrombosis rates were 94%, 87%, and 83%, respectively. Major bleeding events occurred in 12 patients (3.6%), but none were related to the AngioJet procedure. CONCLUSIONS: PEARL registry data demonstrate that rheolytic PCDT treatment of DVT is safe and effective, and can potentially reduce the need for concomitant CDT and intensive care.

Recanalization of chronic total occlusions of the superior mesenteric artery in patients with chronic mesenteric ischemia: technical and clinical outcomes.

PURPOSE: To evaluate the safety and outcomes of endovascular recanalization of chronic total occlusions (CTOs) of the superior mesenteric artery (SMA) in patients with chronic mesenteric ischemia (CMI). MATERIALS AND METHODS: A single-institution retrospective review was performed of 47 consecutive patients (18 male, 29 female) who underwent endovascular stent placement for CTOs of the SMA between February 2006 and November 2012. All patients had symptoms of CMI. Procedural and follow-up data were collected for assessment of technical success, safety, and outcome. RESULTS: Technical success was achieved in 41 of 47 patients (87%). Forty-two of the 47 procedures were performed from a femoral approach. Fifteen patients underwent concurrent revascularization of the celiac artery. All patients who underwent successful recanalization reported symptomatic improvement. Kaplan-Meier analysis revealed primary freedom from symptomatic recurrence of 95% at 12 months and 78% at 24 months. Symptomatic recurrence was observed in seven patients, all of whom underwent successful assisted or secondary endovascular procedures. Secondary freedom from symptomatic recurrence rates were 100% at 12 months and 88% 24 months. There were three (7%) minor access-related complications and no major complications. CONCLUSIONS: Endovascular stent-assisted recanalization of chronic SMA occlusions is safe and effective, with an acceptable rate of technical success and excellent midterm clinical outcomes.