Mark J. Garcia

A Prospective, Single-Arm, Multicenter Trial of Ultrasound-Facilitated, Catheter-Directed, Low-Dose Fibrinolysis for Acute Massive and Submassive Pulmonary Embolism : The SEATTLE II Study

OBJECTIVES This study conducted a prospective, single-arm, multicenter trial to evaluate the safety and efficacy of ultrasound-facilitated, catheter-directed, low-dose fibrinolysis, using the EkoSonic Endovascular System (EKOS, Bothell, Washington). BACKGROUND Systemic fibrinolysis for acute pulmonary embolism (PE) reduces cardiovascular collapse but causes hemorrhagic stroke at a rate exceeding 2%. METHODS Eligible patients had a proximal PE and a right ventricular (RV)-to-left ventricular (LV) diameter ratio ≥0.9 on chest computed tomography (CT). We included 150 patients with acute massive (n = 31) or submassive (n = 119) PE. We used 24 mg of tissue-plasminogen activator (t-PA) administered either as 1 mg/h for 24 h with a unilateral catheter or 1 mg/h/catheter for 12 h with bilateral catheters. The primary safety outcome was major bleeding within 72 h of procedure initiation. The primary efficacy outcome was the change in the chest CT-measured RV/LV diameter ratio within 48 h of procedure initiation. RESULTS Mean RV/LV diameter ratio decreased from baseline to 48 h post-procedure (1.55 vs. 1.13; mean difference, -0.42; p < 0.0001). Mean pulmonary artery systolic pressure (51.4 mm Hg vs. 36.9 mm Hg; p < 0.0001) and modified Miller Index score (22.5 vs. 15.8; p < 0.0001) also decreased post-procedure. One GUSTO (Global Utilization of Streptokinase and Tissue Plasminogen Activator for Occluded Coronary Arteries)-defined severe bleed (groin hematoma with transient hypotension) and 16 GUSTO-defined moderate bleeding events occurred in 15 patients (10%). No patient experienced intracranial hemorrhage. CONCLUSIONS Ultrasound-facilitated, catheter-directed, low-dose fibrinolysis decreased RV dilation, reduced pulmonary hypertension, decreased anatomic thrombus burden, and minimized intracranial hemorrhage in patients with acute massive and submassive PE. (A Prospective, Single-arm, Multi-center Trial of EkoSonic® Endovascular System and Activase for Treatment of Acute Pulmonary Embolism (PE) [SEATTLE II]; NCT01513759).

The safety and effectiveness of the retrievable option inferior vena cava filter: A United States prospective multicenter clinical study

PURPOSE To evaluate the safety and effectiveness of the retrievable Option inferior vena cava (IVC) filter in patients at risk for pulmonary embolism (PE). MATERIALS AND METHODS This was a prospective, multicenter, single-arm clinical trial. Subjects (N = 100) underwent implantation of the IVC filter and were followed for 180 days; subjects whose filters were later removed were followed for 30 days thereafter. The primary objective was to determine whether the one-sided lower limit of the 95% CI for the observed clinical success rate was at least 80%. Clinical success was defined as technical success (deployment of the filter such that it was judged suitable for mechanical protection from PE) without subsequent PE, significant filter migration or embolization, symptomatic caval thrombosis, or other complications. RESULTS Technical success was achieved in 100% of subjects. There were eight cases of recurrent PE, two cases of filter migration (23 mm), and three cases of symptomatic caval occlusion/thrombosis (one in a subject who also experienced filter migration). No filter embolization or fracture occurred. Clinical success was achieved in 88% of subjects; the one-sided lower limit of the 95% CI was 81%. Retrieval was successful at a mean of 67.1 days after implantation (range, 1-175 d) for 36 of 39 subjects (92.3%). All deaths (n = 17) and deep vein thromboses (n = 18) were judged to have resulted from preexisting or intercurrent illnesses or interventions and unrelated to the filter device; all deaths were judged to be unrelated to PE. CONCLUSIONS Placement and retrieval of the Option IVC filter were performed safely and with high rates of clinical success.

Right ventricular migration of a recovery IVC filter's fractured wire with subsequent pericardial tamponade.

A Recovery filter (C.R. Bard, Tempe, AZ, USA) is a device for pulmonary embolism prophylaxis. There have been few case reports involving the migration of this particular filter or of a broken wire migrating to the heart. We report a case of right ventricular migration of a fractured wire from this filter in a patient who subsequently developed pericardial tamponade and required open heart surgery to extract the fractured wire. We discuss the current US Food and Drug Administration (FDA)-approved nonpermanent inferior vena cava filters and their reported complications. These complications can be life-threatening and may require immediate surgical intervention.

Pharmacomechanical Catheter-Directed Thrombolysis for Deep-Vein Thrombosis

Background The post‐thrombotic syndrome frequently develops in patients with proximal deep‐vein thrombosis despite treatment with anticoagulant therapy. Pharmacomechanical catheter‐directed thrombolysis (hereafter “pharmacomechanical thrombolysis”) rapidly removes thrombus and is hypothesized to reduce the risk of the post‐thrombotic syndrome. Methods We randomly assigned 692 patients with acute proximal deep‐vein thrombosis to receive either anticoagulation alone (control group) or anticoagulation plus pharmacomechanical thrombolysis (catheter‐mediated or device‐mediated intrathrombus delivery of recombinant tissue plasminogen activator and thrombus aspiration or maceration, with or without stenting). The primary outcome was development of the post‐thrombotic syndrome between 6 and 24 months of follow‐up. Results Between 6 and 24 months, there was no significant between‐group difference in the percentage of patients with the post‐thrombotic syndrome (47% in the pharmacomechanical‐thrombolysis group and 48% in the control group; risk ratio, 0.96; 95% confidence interval [CI], 0.82 to 1.11; P=0.56). Pharmacomechanical thrombolysis led to more major bleeding events within 10 days (1.7% vs. 0.3% of patients, P=0.049), but no significant difference in recurrent venous thromboembolism was seen over the 24‐month follow‐up period (12% in the pharmacomechanical‐thrombolysis group and 8% in the control group, P=0.09). Moderate‐to‐severe post‐thrombotic syndrome occurred in 18% of patients in the pharmacomechanical‐thrombolysis group versus 24% of those in the control group (risk ratio, 0.73; 95% CI, 0.54 to 0.98; P=0.04). Severity scores for the post‐thrombotic syndrome were lower in the pharmacomechanical‐thrombolysis group than in the control group at 6, 12, 18, and 24 months of follow‐up (P<0.01 for the comparison of the Villalta scores at each time point), but the improvement in quality of life from baseline to 24 months did not differ significantly between the treatment groups. Conclusions Among patients with acute proximal deep‐vein thrombosis, the addition of pharmacomechanical catheter‐directed thrombolysis to anticoagulation did not result in a lower risk of the post‐thrombotic syndrome but did result in a higher risk of major bleeding. (Funded by the National Heart, Lung, and Blood Institute and others; ATTRACT ClinicalTrials.gov number, NCT00790335.)

The Toxicity of Liver Directed Yttrium-90 Microspheres in Primary and Metastatic Liver Tumors

Background: Selective Internal Radiation (SIR) therapy with yttrium-90 microspheres has become an alternative approach to treat hepatic tumors. Methods: A single institution retrospective chart review was performed to assess the safety of SIR microspheres in twenty-one patients with hepatic malignancies. The yttrium-90 radiation dose was dependent upon the percentage of tumor involvement of the liver, with a dose modification (reduction) adjusted for macroaggregated albumin (MAA) shunted to the lung. Results: Twenty-one patients underwent twenty-five treatments with SIR microsphere therapy for primary and metastatic liver tumors. One mortality was secondary to fulminant hepatic failure after developing radiation hepatitis. Morbidities included radiation hepatitis (1) and peptic ulcer disease (6). Conclusions: The application of SIR microspheres has been utilized for a variety of liver tumors. Although it has been a useful treatment option in selected patients, safety still remains an issue.

Contemporary Results of Endovascular Repair of Abdominal Aortic Aneurysms: Effect of Anatomical Fixation on Outcomes

Purpose: To report the contemporary controlled trial experience with the fully supported unibody Powerlink stent-graft for endovascular treatment of abdominal aortic aneurysm (AAA). Methods: Between 2000 and 2008, 3 prospective multicenter trials of the Powerlink system evaluated 157 AAA patients (141 men; mean age 72.0±9.1 years) with mean AAA sac diameter of 5.6±0.9 cm who received a bifurcated stent-graft featuring anatomical fixation at the aortoiliac bifurcation and proximal sealing with extension stent-grafts as needed. Challenging infrarenal aortic neck anatomy was present in 83% of patients. Postoperative follow-up occurred at defined intervals to 5 years. Results: Technical success was achieved in 99% of patients. Aneurysm exclusion was achieved in all patients over a mean procedure time of 132±58 minutes. No aneurysm-related deaths, ruptures, conversions, or migrations have been observed to current follow-up as these aneurysms have continued to remodel, with ≥92% of patients free from sac growth. Conclusion: The implant technique of placing a fully-supported unibody stent-graft at the aortoiliac bifurcation with proximal sealing appears to safely and effectively reline the aorta and exclude aneurysms. Results from controlled clinical trial experience suggest this algorithm can provide stable, secure fixation for patients with challenging infrarenal aortic neck anatomy.

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.

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.

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 Management of Acute Pulmonary Embolism Using the Ultrasound-Enhanced EkoSonic System

Acute, symptomatic pulmonary embolism (PE) in the massive and submassive categories continues to be a healthcare concern with significant risk for increased morbidity and mortality. Despite increased awareness and venous thromboembolism prophylaxis, endovascular treatment is still an important option for many of these patients. There are a variety of techniques and devices used for treating PE, but none have been evaluated as extensively as the EkoSonic endovascular system that is also currently the only FDA-approved device for the treatment of pulmonary embolism. This article describes the use of the EkoSonic device for this patient population.