Stephanie N. Thompson

Medication discrepancies identified at time of hospital discharge in a geriatric population.

BACKGROUND It has been reported that 14.1% of geriatric patients experience ≥1 medication discrepancies after hospitalization. OBJECTIVE The goal of this study was to identify and characterize discharge medication list discrepancies among geriatric patients and to describe characteristics associated with discrepancies. METHODS An institutional review board-approved retrospective review was conducted of patients aged ≥65 years discharged from hospitalist and internal medicine services at a large tertiary care hospital from August 2008 to December 2009. A random cohort of 200 patients was selected and categorized by age, gender, attending medical service, and the absence or presence of a pharmacist on the service. Medication lists were obtained from physician discharge summaries, discharge orders, and nursing discharge lists. RESULTS A total of 1923 medication discrepancies were identified, consisting of 402 related to the absence or presence of a medication, 298 related to the dosage administered at one time, 223 related to the number of daily doses, and 1000 related to the route of administration. Physician discharge summaries contained the most medication discrepancies. There was no relationship between patient age and the number of medication discrepancies (r(2) = 0.006; P = 0.279), whereas there was a linear relationship between the number of medications and the number of discrepancies (r(2) = 0.249; P < 0.001). The internal medicine team with a pharmacist had a lower average number of discrepancies per patient compared with other medicine services that did not have a pharmacist present. CONCLUSIONS Medication discrepancies at the time of hospital discharge are a common occurrence for geriatric patients. Physician summaries might be the least reliable source of discharge medication lists. The number of discrepancies appears to not be associated with patient age, but rather with the number of medications at discharge. Discrepancies among medication lists are common, and the presence of a pharmacist may reduce the number that occur.

C-reactive protein and brain natriuretic peptide as predictors of adverse events after lower extremity endovascular revascularization

BACKGROUND High-sensitivity C-reactive protein (hsCRP) and brain natriuretic peptide (BNP) have been shown to be independent predictors of adverse cardiovascular outcomes and increased risk of secondary interventions or limb loss in patients with peripheral arterial disease (PAD). To assist clinicians in decision-making about treatment approaches and predicting postprocedure mortality and morbidity, we retrospectively examined patients with preprocedure hsCRP and BNP levels who underwent elective angioplasty or stent placement for lower extremity PAD. METHODS The study period was from January 1, 2007, to December 31, 2012, and patients were included who had angioplasty or stenting for PAD. Minimal required follow-up for study inclusion was at least one postoperative ankle-brachial index, contrast angiography, or duplex imaging of the treated limb. Events of interest included major adverse limb events (MALE), defined as target vessel revascularization, amputation, or disease progression by 1 year, and major adverse cardiovascular events (MACE; stroke, myocardial infarction, or death) by 2 years. Elevated/abnormal values for our biomarkers of interest were established by the upper limits of our institutions clinical laboratory reference range (hsCRP, >0.80 mg/dL; BNP, >100 pg/mL). RESULTS A total of 159 limbs in 118 patients were included in analysis (42% men; median age [range], 64 [42-87] years). All limbs were symptomatic (Rutherford classification: 1-6). Iliac artery revascularization without other adjunct lower extremity intervention was performed in 60% of the limbs. High hsCRP levels (>0.80 mg/dL) were present in 32 patients (27%) and high BNP values (>100 pg/mL) in 24 patients (20%). Kaplan-Meier analysis with log-rank comparison demonstrated that elevated hsCRP levels were associated with MALE but only in limbs receiving interventions distal to the iliac arteries (P = .005). High BNP levels did not affect MALE rates (P = .821). Conversely, both elevated BNP levels (hazard ratio, 5.6; 95% confidence interval [CI], 2.0-5.8; P = .001) and hsCRP levels (hazard ratio, 2.9; 95% CI, 1.1-7.6; P = .034) predicted MACE at 2 years in the presence of confounders in Cox proportional hazards multivariate analysis. Patients with high preintervention values of hsCRP and BNP were 10.6 times (95% CI, 2.6-42.9; P = .001) more likely to experience MACE than were patients with normal hsCRP and BNP values. CONCLUSIONS After lower extremity endovascular interventions, elevated preprocedural hsCRP levels are associated with MALE (femoral-popliteal interventions), and elevated levels of hsCRP and BNP are associated with late cardiovascular events.

Reporting Compliance of Stroke Trials: Cross-Sectional Analysis

BACKGROUND The FDA mandates timely reporting of all clinical trials conducted in the United States. However, often the results are not reported in a timely manner, resulting in wastage of finite resources. We assessed the reporting of results of completed stroke trials and compared the reporting trends between U.S. and non-U.S. stroke trials. METHODS We assessed consecutive clinical stroke trials registered as completed in ClinicalTrials.gov between January 1, 2008 and January 1, 2015. Descriptive data collected included study phase, study type, participant age, number of enrolled patients, study locations, start and primary completion dates, result availability, time to reporting (months), sponsorship, funding sources, and publication status. We also performed manual search for stroke trials in Pubmed, Web of Science, and Google scholar. RESULTS Out of a total 140 completed trials, 39 trials (35,359 patients) involved at least 1 U.S. center and 101 trials (58,542 patients) were conducted in non-U.S. centers. Of the trials involving at least a single U.S. center, 31 of 39 (79%) reported their results, whereas only 6 of 31 (19%) reported their results within 1 year. Of the trials conducted at non-U.S. centers, 72 of 101 (71%) reported their results, whereas results for 24 of 72 (33%) trials were available within a year of completion. The time to reporting of results was significantly lower for all the included clinical trials in the 2012-2014 period (P < .001, Cohens d = .726) as compared to the 2008-2011 period. CONCLUSION Only one-fifth of completed stroke trials involving at least a single U.S. center report their results within 1 year. Additionally, every fifth completed trial involving stroke patients at U.S. centers remain unreported.

Management of Iatrogenic Pseudoaneurysms in Patients Undergoing Coronary Artery Bypass Grafting

Objective: A plethora of papers have been written regarding postcatheterization femoral pseudoaneurysms. However, literature is lacking on pseudoaneurysmal management in patients undergoing coronary artery bypass grafting (CABG). Thus, we examined if pseudoaneurysms with subsequent CABG can be managed with the same strategies as those not exposed to the intense anticoagulation accompanying CABGs. Methods: During a 14-year study period, we retrospectively examined femoral iatrogenic pseudoaneurysms (IPSAs) diagnosed postheart catheterization in patients having a subsequent CABG. Patient information was obtained from electronic medical records and included pseudoaneurysm characteristics, treatment, and resolution. Outcomes of interest included the occurrence of IPSA treatment failures and complications. Results: In the 66 patients (mean age, 66 ± 11 years, 46% male) meeting inclusion criteria, mean dose of heparin received during the CABG procedure was 34 000 ± 23 000 units. The IPSA size distribution was the following: 17% of IPSAs measured <1 cm, 55% between 1 and 3 cm, and 21% measured >3 cm. Pseudoaneurysms were managed with compression, duplex-guided thrombin injection, and surgical repair (1%, 27%, and 26% of cases, respectively). Thrombin injection and surgical repair were 100% effective at treating pseudoaneurysms, with 1 patient experiencing a surgical site infection postsurgical repair. Observation-only management was employed in 30 (45%) patients. Nine of 30 patients with no intervention beyond observation had duplex documented resolution/thrombosis during follow-up. One patient initially managed by observation required readmission and surgical repair of an enlarging pseudoaneurysm (6 cm growth) following CABG. Conclusion: Management of pseudoaneurysms in patients prior to CABG should be similar to those patients not undergoing intense anticoagulation. In appropriate cases, small aneurysms can be safely observed, while thrombin injections are effective and safe as well. Thus, routine open surgical repair is not routinely required in patients with femoral pseudoaneurysms at time of CABG.

Biochemical markers in patients with open reconstructions with peripheral arterial disease

The purpose of our study was to determine outcome differences as a function of baseline high-sensitivity C-reactive protein (hsCRP) and B-type natriuretic peptide (BNP) levels in patients receiving lower extremity open reconstructions for the treatment of peripheral arterial occlusive disease. We retrospectively examined patients who underwent surgical reconstructions performed by a single operator during a seven-year time span who received preoperative hsCRP and BNP testing and post-procedure imaging. Outcomes of interest included major adverse limb events, a composite end point of target vessel revascularization, limb amputation, and disease progression, and major adverse cardiovascular events comprised of stroke, myocardial infarction, and death. A total of 89 limbs in 82 patients were included in analysis. Multivariate analysis demonstrated that higher hsCRP levels (>3.0 mg/L) trended toward, but failed to significantly associate with major adverse limb events at 24 months (hazard ratio: 2.2 [1.0–5.2], p = 0.06), however the use of a vein bypass conduit (vs. prosthetic reconstruction) significantly predicted major adverse limb events (hazard ratio: 3.2 [1.5–6.9], p < 0.01). Elevated BNP levels (>100 pg/ml), but not hsCRP, associated with major adverse cardiovascular events (hazard ratio: 3.5 [1.2–10.3], p = 0.03). Preoperative biochemical markers may assist in clinical decision making and stratifying patients regarding adverse events following open reconstructions.

Early results with LifeStent implantation in RESILIENT and non-RESILIENT inclusion criteria patients.

The purpose of our study was to determine outcomes of patients receiving the LifeStent (Bard Peripheral Vascular, Tempe, AZ) for femoropopliteal peripheral arterial disease in real-world academic practice outside the limitations of an industry supported trial. All patients from 2009 to 2012 at our institution who received a LifeStent during endovascular interventions and had follow-up were included. Outcomes evaluated included patency and freedom from limb loss. A total of 166 limbs in 151 patients had the LifeStent implanted in de novo vessels (54% male; 68 ± 12 years). Eighty-percent of limbs did not meet RESILIENT criteria due to Rutherford category >3 (51%), TransAtlantic Inter-Society Consensus II classifications C/ D (51%), zero runoff vessels (6%), or stent location (17%). Primary patency rates were 81% at 6 months and 58% at 12 months with predictors for primary patency loss at 1 year including Rutherford category >3 (HR: 1.8 (95% CI: 1.0–3.1), p = 0.04), tobacco use (HR: 1.8 (95% CI: 1.0–3.3), p = 0.04), and no clopidogrel at discharge (HR: 3.2 (95% CI: 1.6–6.7), p < 0.01). A preintervention Rutherford category >3 predicted 24-month limb loss (HR, 16.0 (95% CI: 2.0–122.0), p < 0.01). The LifeStent is a viable option regardless of the TransAtlantic Inter-Society Consensus II classification; however, critical limb ischemia, current tobacco use, and absence of clopidogrel on discharge predict decreased patency on follow-up.

Ten-Year Experience of Vascular Surgeon Management of Iatrogenic Pseudoaneurysms: Do Anticoagulant and/or Antiplatelet Medications Matter?

BACKGROUND Previous studies examining the natural history of femoral pseudoaneurysms (PSAs) were performed before the current era of anticoagulant and/or antiplatelet therapy. The purpose of our study was to elucidate in a vascular surgeon directed approach to PSAs, the association between medication use and the failure of conservative, observation-only management. METHODS We retrospectively examined 308 femoral iatrogenic PSAs diagnosed via duplex imaging at our institution during a 10-year time period (2004-2013). Information on PSA characteristics, treatment, and antiplatelet and/or anticoagulant medication usage was obtained. We identified patients who failed observation-only conservation management, with failure defined as the need for delayed treatment because of PSAs triggered by either expansion (≥ 1 cm increase or size enlarging to ≥ 3 cm) and/or persistence (≥ 15 days). RESULTS Immediate and/or acute treatments of PSAs included 1 ultrasound-guided compression, 14 surgical repairs, and 126 thrombin injections. Of the 167 PSAs initially managed by observation only, 70 (42%) were found by ultrasound imaging to thrombosis spontaneously. An additional 70 (42%) patients had the diagnosis of PSA <3 cm and were managed conservatively with only clinical follow-up. Twenty-seven PSAs (16%) originally managed conservatively required additional treatment because of expansion and/or persistence. Patients receiving dual-antiplatelet therapy had higher rates of failed conservative management (44%) than patients not on dual therapy (9%, P < 0.01). The number of antiplatelet and/or anticoagulant medications used during observation was larger in patients failing conservative management (2.0 ± 0.7) versus patients not requiring additional intervention (1.5 ± 0.7, P < 0.01). CONCLUSIONS Most of the PSAs initially managed with observation-only did not require additional intervention. However, anticoagulant and/or antiplatelet agents use associated with PSAs required further intervention after failing observation-only management. When observation is the chosen strategy for PSA management, especially in the setting of aggressive antithrombotic and dual-antiplatelet therapy, surveillance is required to ensure proper resolution.

Reporting bias in completed epilepsy intervention trials: A cross-sectional analysis

OBJECTIVE To explore the evidence of reporting bias among completed epilepsy intervention trials (EITs) and compliance of applicable EITs to Food and Drug Administration Amendments Act (FDAAA). METHODS We included consecutive EITs registered as completed on ClinicalTrials.gov from 2008 to 2015. Descriptive data was collected including study type, study phase, funding source, primary completion date, and result reporting date. Time to result reporting was analyzed using Kaplan-Meier estimates for two time periods (2008-2011 and 2012-2015). PubMed, Web of Science, and Google scholar databases were manually searched for publication details. RESULTS Overall, 95/126 EITs (75%) reported, while remaining 31/126 (25%) did not report their results. Time to reporting was significantly lower for trials completed during 2012-2015 (16.5 months; 95% CI: 13.60-19.40; p = .002; Cohens d = 0.68) as compared to the trials completed during 2008-2011 (25.9 months; 95% CI: 21.56-30.22). 72/126 trials were conducted in at least one U.S. center. 56/72 (78%) of the trials met the FDAAA criteria, while only 19/56 (34%) reported within the mandated one-year time frame. CONCLUSION The lack of reporting of nearly one-quarter of completed epilepsy intervention trials suggests existence of reporting bias. As such, it should be considered an important criterion for determining risk of bias in epilepsy systematic reviews.