The aim of this trial was to determine whether ultrasound-assisted thrombolysis (USAT) is superior to standard catheter-directed thrombolysis (SCDT) in pulmonary arterial thrombus reduction for ...patients with submassive pulmonary embolism (sPE).
Catheter-directed therapy has been increasingly used in sPE and massive pulmonary embolism as a decompensation prevention and potentially lifesaving procedure. It is unproved whether USAT is superior to SCDT using traditional multiple-side-hole catheters in the treatment of patients with pulmonary embolism.
Adults with sPE were enrolled. Participants were randomized 1:1 to USAT or SCDT. The primary outcome was 48-hour clearance of pulmonary thrombus assessed by pre- and postprocedural computed tomographic angiography using a refined Miller score. Secondary outcomes included improvement in right ventricular-to-left ventricular ratio, intensive care unit and hospital stay, bleeding, and adverse events up to 90 days.
Eighty-one patients with acute sPE were randomized and were available for analysis. The mean total dose of alteplase for USAT was 19 ± 7 mg and for SCDT was 18 ± 7 mg (P = 0.53), infused over 14 ± 6 and 14 ± 5 hours, respectively (P = 0.99). In the USAT group, the mean raw pulmonary arterial thrombus score was reduced from 31 ± 4 at baseline to 22 ± 7 (P < 0.001). In the SCDT group, the score was reduced from 33 ± 4 to 23 ± 7 (P < 0.001). There was no significant difference in mean thrombus score reduction between the 2 groups (P = 0.76). The mean reduction in right ventricular/left ventricular ratio from baseline (1.54 ± 0.30 for USAT, 1.69 ± 0.44 for SCDT) to 48 hours was 0.37 ± 0.34 in the USAT group and 0.59 ± 0.42 in the SCDT group (P = 0.01). Major bleeding (1 stroke and 1 vaginal bleed requiring transfusion) occurred in 2 patients, both in the USAT group.
In the SUNSET sPE (Standard vs. Ultrasound-Assisted Catheter Thrombolysis for Submassive Pulmonary Embolism) trial, patients undergoing USAT had similar pulmonary arterial thrombus reduction compared with those undergoing SCDT, using comparable mean lytic doses and durations of lysis.
Antiplatelet pharmacotherapy for endovascular interventions has been widely adopted, with clopidogrel being one of the most common agents prescribed. A fraction of patients is resistant to ...clopidogrel resulting in decreased platelet inhibition despite adequate use. This finding is often termed high on-treatment platelet reactivity (HPR) and may lead to decreased patency in lower extremity arterial endovascular interventions. Current literature on HPR with lower extremity arterial endovascular interventions is limited to only a few studies. Resistance to clopidogrel is largely a result of CYP2C19 enzyme loss of function alleles. Several tests are available to measure clopidogrel resistance but light transmittance aggregometry remains the gold standard, yet direct genetic testing may be more reliable. One-year patency rates following lower extremity arterial endovascular interventions in patients with clopidogrel resistance (HPR) range between 35%-83% whereas those with the proper response to clopidogrel range between 73%-100%. Patients with decreased CYP2C19 activity show a significant decrease in one-year patency of endovascular femoropopliteal interventions (35% vs. 73%; p=0.006). Among patients tested for platelet function after in-stent thrombosis, up to 53% are resistant to clopidogrel. Lack of robust data limits our ability to predict patency in lower extremity arterial interventions for patients with HPR, but there is little doubt that longer patency seems to favor non-HPR patients. Large population, prospective trials are needed to guide our practice.
Catheter-based interventions for acute pulmonary embolism (PE) have evolved over the past decades to achieve the benefits of systemic thrombolysis, avoiding though its systemic complications and ...offering a therapeutic option to a wider spectrum of PE patients who may be contraindicated for thrombolytics. Although numerous observational, retrospective, or small prospective studies have been performed to evaluate the myriad devices used in the preceding years, few are of adequate quality to support widespread use. However, we were seeing an increasing use of catheter thrombolytic and aspiration thrombectomy procedures in both US and Europe. Evidence is building up through several industry trials, and more recently, the PE-Thrombus Removal with Adjunctive Catheter-directed Therapy randomized National Institutes of Health-funded trial was approved to evaluate their benefit over anticoagulation alone in intermediate risk patients. The current evolution of these techniques and existing evidence for their use are summarized.
Asymptomatic carotid stenosis has been shown to be associated with progressive neurocognitive decline, but the effects of carotid endarterectomy (CEA) on this are not well defined. Due to the wide ...heterogeneity of studies and lack of standardization in cognitive function tests and study design, there is mounting scientific evidence to support the notion that CEA is effective in reversing or slowing neurocognitive decline; however, definitive conclusions are difficult to make. Further, while the association between ACS and cognitive decline has been well document, a direct etiological role has not been established. More research is required to elucidate the relationship between asymptomatic carotid stenosis and the benefit of carotid endarterectomy and its potential protective effects regarding cognitive decline. This article aims to review current evidence in preoperative and postoperative cognitive function in asymptomatic patients with carotid stenosis undergoing CEA.
Objective Primary closure after carotid endarterectomy (CEA) has been much maligned as an inferior technique with worse outcomes than in patch closure. Our purpose was to compare perioperative and ...long-term results of different CEA closure techniques in a large institutional experience. Methods A consecutive cohort of CEAs between January 1, 2000, and December 31, 2010, was retrospectively analyzed. Closure technique was used to divide patients into three groups: primary longitudinal arteriotomy closure (PRC), patch closure (PAC), and eversion closure (EVC). End points were perioperative events, long-term strokes, and restenosis ≥70%. Multivariate regression models were used to assess the effect of baseline predictors. Results There were 1737 CEA cases (bilateral, 143; mean age, 71.4 ± 9.3 years; 56.2% men; 35.3% symptomatic) performed during the study period with a mean clinical follow-up of 49.8 ± 36.4 months (range, 0-155 months). More men had primary closure, but other demographic and baseline symptoms were similar between groups. Half the patients had PAC, with the rest evenly distributed between PRC and EVC. The rate of nerve injury was 2.7%, the rate of reintervention for hematoma was 1.5%, and the length of hospital stay was 2.4 ± 3.0 days, with no significant differences among groups. The combined stroke and death rate was 2.5% overall and 3.9% and 1.7% in the symptomatic and asymptomatic cohort, respectively. Stroke and death rates were similar between groups: PRC, 11 (2.7%); PAC, 19 (2.2%); EVC, 13 (2.9%). Multivariate analysis showed baseline symptomatic disease (odds ratio, 2.4; P = .007) and heart failure (odds ratio, 3.1; P = .003) as predictors of perioperative stroke and death, but not the type of closure. Cox regression analysis demonstrated, among other risk factors, no statin use (hazard ratio, 2.1; P = .008) as a predictor of ipsilateral stroke and severe (glomerular filtration rate <30 mL/min/1.73 m2 ) renal insufficiency (hazard ratio, 2.6; P = .032) as the only predictor of restenosis ≥70%. Type of closure did not have any predictive value. Conclusions In our study, baseline risk factors and statin use, but not the type of closure, affect perioperative and long-term outcomes after CEA.
Objective The purpose of this study was to evaluate contemporary practice and outcomes of open repair (OR) or endovascular repair (ER) for popliteal artery aneurysms (PAAs). Methods Consecutive ...patients with PAA treated at one institution from January 2006 to March 2014 were reviewed under an Institutional Review Board-approved protocol. Demographics, indications, anatomic characteristics, and outcomes were collected. Standard statistical methods were used. Results A total of 186 PAAs were repaired in 156 patients (110 ORs, 76 ERs) with a mean age of 71 ± 11 years, and most were male (96%). Mean follow-up was 34.9 ± 28.6 months for OR and 28.3 ± 25.8 months for ER ( P = .12). Comorbidities were similar between groups. OR was used in more patients with PAA thrombosis (41.8% vs 5.3%; P < .001), acute ischemia (24.5% vs 9.2%; P = .010), and ischemic rest pain (34.5% vs 6.6%; P < .001). Mean tibial (Society for Vascular Surgery) runoff score was 5.0 for OR vs 3.3 for ER ( P = .006). OR was associated with increased 30-day complications (22% vs 2.6%; P < .001) and mean postoperative stay (5.8 vs 1.6 days; P < .001). There was no difference in 30-day mortality (OR, 1.8%; ER, 0%; P = .56) or major amputation rate (OR, 3.7%; ER, 1.3%; P = .65). Primary, primary assisted, and secondary patency rates were similar at 3 years (OR, 79.5%, 83.7%, and 85%; ER, 73.2%, 76.3%, and 83%; P = NS). Among 130 patients presenting electively without acute ischemia or thrombosed PAA (63 ORs and 67 ERs), OR had better 3-year primary patency (88.3% vs 69.8%; P = .030) and primary assisted patency (90.2% vs 73.5%; P = .051) but similar secondary patency (90.2% vs 82%; P = .260). ER thrombosis was noted in 8 of 24 patients treated in 2006-2008 (33%; mean time to failure, 49 months) but in only 4 of 51 patients treated in 2009-2013 (7.8%; mean time to failure, 30 months), suggesting a steep learning curve. Conclusions ER is a safe and durable option for PAA, with lower complication rates and a shorter length of stay. OR has superior primary patency in patients treated electively but no difference in midterm secondary patency and amputations.
Catheter-directed interventions for acute iliofemoral deep venous thrombosis (DVT) have been increasingly used over the past 15 years to target severe symptomatology and prevention of post-thrombotic ...syndrome incidence or reduce its severity if it were to develop. Aside from successful thrombus removal, adjunctive stents are frequently required to treat an uncovered lesion or significant residual thrombus to ensure quality of life improvement besides retarding DVT recurrence and post-thrombotic syndrome. As the evidence is mounting, the need and role for stenting, as well as the principles of an optimal technique, in the acute DVT setting are now better understood. Accumulating experience appears to favor stenting in the acute setting. The diameter of the stent, the length, the extent of overlapping, and the landing zones are crucial determinants of a successful durable outcome. This article endeavors to guide the interventionalist on stenting when encountering a patient with acute symptomatic iliofemoral DVT with concerns of quality of life impairment.
The aim of this study was to evaluate changes in the utilization and outcomes of surgery after Medicaid Expansion (ME) for patients with peripheral artery disease (PAD).
Recent studies have ...demonstrated increased insurance coverage and improved care with the Affordable Care Act's (ACA) state expansion of Medicaid.
Infrainguinal bypass procedures performed due to occlusive pathology in the Vascular Quality Initiative database between 2010 and 2017 were included. Primary outcomes including postoperative mortality and major adverse limb events (MALE) at 1-year of follow-up were analyzed using interrupted time-series analysis (ITS).
Out of 26,446 infrainguinal bypass procedures, 13,955 (52.8%) were included in this analysis. ME states witnessed an annual decrease in infrainguinal surgery for acute ischemia annual change in post vs pre-ME period (95% confidence interval): -4.3% (-7.5% to -1.0%), P = 0.02 and an increase in revascularization for claudication 3.7% (1.7%-5.6%), P = 0.01. Among nonacute cases, elective procedures increased in ME states 3.9% (0.1%-7.7%), P = 0.05 along with a significant annual decrease in in-hospital mortality -0.4% (-0.8 to -0.02), P = 0.04) and MALE at 1 year of follow up -9.0% (-20.3 to 2.3), P = 0.09. These results were statistically significant after comparing them with the annual trend changes in states which did not adopt ME.
The adoption of ME in 2014 was associated with significant increase in the use of infrainguinal bypass for nonsevere and elective cases, along with improved in-hospital mortality and MALE at 1 year. Longer follow-up is needed to evaluate the impact of ME on other aspects of care and longer term outcomes of PAD patients.
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