Randomized Trial Comparing Standard Versus Ultrasound-Assisted Thrombolysis for Submassive Pulmonary Embolism: The SUNSET sPE Trial.

OBJECTIVES: 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). BACKGROUND: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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.

A study of time saved by emergency medicine physicians through working with clinical pharmacists in the emergency department.

PURPOSE: To describe quantitatively the impact on physician efficiency when an Emergency Medicine Clinical Pharmacist (EMCP) is available to Emergency Department (ED) physicians while working under a collaborative care agreement in a Michigan-based Health System. METHODS: Four EMCPs each logged and categorized their time during 14 ten hour shifts, for a total of 56 shifts or 560 total hours worked. There were nine categories observed including: culture call back, urine, blood, or other culture follow up, antibiotic changes, patient call-backs, pharmacy call backs, critically ill, and general questions. RESULTS: EMCPs saved ED physicians an average of 75 min per shift, with the highest yield categories being general questions (25.2 min per shift (mps), standard error (SE) = 2.67), critically ill patient service (11.5 mps, SE = 2.66), and urine culture follow-ups (11.3 mps, SE = 1.05). CONCLUSIONS: EMCPs in the ED save physicians a significant amount of time per shift, and categorically the most time saved was in fielding general questions, time spent with critically ill patients, and following up on urine cultures. The time saved by physicians could translate into more patients seen per shift.

Clopidogrel Resistance in Lower Extremity Arterial Endovascular Interventions.

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.