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.

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.

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 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.

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.

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.

Endovascular recanalization of native chronic total occlusions in patients with failed lower-extremity bypass grafts.

PURPOSE: To investigate the feasibility, safety, and outcome of endovascular recanalization of native chronic total occlusions (CTOs) in patients with failed lower-extremity bypass grafts. MATERIALS AND METHODS: Retrospective review of 19 limbs in 18 patients with failed lower-extremity bypass grafts that underwent recanalization of native arterial occlusions between February 2009 and April 2013 was performed. Nine of the limbs presented with acute ischemia and 10 presented with chronic ischemia, including eight with critical limb ischemia and two with disabling claudication. RESULTS: The mean patency of the failed bypass grafts (63% venous) was 27 months. All limbs had Transatlantic Inter-Society Consensus class D lesions involving the native circulation. Technical success of the endovascular recanalization procedure was achieved in all but one limb (95%). The mean ankle brachial indices before and after treatment were 0.34 and 0.73, respectively. There were no major complications or emergency amputations. Mean patient follow-up was 64 weeks, and two patients were lost to follow-up. Primary patency rates at 3, 6, and 12 months were 87%, 48%, and 16%, respectively. Successful secondary procedures were performed in seven patients, with secondary patency rates at 3, 6, and 12 months of 88%, 73%, and 44%, respectively. Limb salvage rates at 12 and 24 months were 94% and 65%, and amputation-free survival rates at 12 and 24 months were 87% and 60%, respectively. CONCLUSIONS: Endovascular recanalization of native CTOs in patients with failed lower-extremity bypass grafts is technically feasible and safe and results in acceptable limb salvage.