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Cost-effectiveness of drug-eluting stents including the economic impact of late stent thrombosis.

Am J Cardiol. 2009 Feb 1;103(3):338-44

Authors: Filion KB, Roy AM, Baboushkin T, Rinfret S, Eisenberg MJ

Recent studies examining the effectiveness of drug-eluting stents (DES) have found that the use of DES is associated with a significant increase in the incidence of late stent thrombosis (LST). Previous cost-effectiveness analyses of DES have not accounted for the costs associated with LST. In this study, published research was reviewed to identify studies that compared the cost-effectiveness of DES with that of bare-metal stents and to identify the incidence of LST. Probable costs were assigned to LST-related myocardial infarction and death on the basis of the treatment costs for these outcomes. These costs as well as those of extended clopidogrel therapy were then incorporated into the Sirolimus-Eluting Balloon Expandable Stent in the Treatment of Patients With De Novo Native Coronary Artery Lesions (SIRIUS) and TAXUS-IV cost-effectiveness data. This review found that the incidence of LST ranged from 0.2% to 0.7%. Assuming a base case LST incidence of 0.5%, a cost per death of $20,000, a cost per myocardial infarction of $20,000, and a cost of an additional 2 years of clopidogrel therapy of $2,428 per patient, the costs per revascularization avoided were $15,056 for the SIRIUS trial and $25,210 for the TAXUS-IV trial. The costs per quality-adjusted life-year gained were $250,935 and $257,591, respectively. Sensitivity analyses revealed that the costs per revascularization avoided varied from $14,618 to $15,830 for the SIRIUS trial and from $24,540 to $26,396 for the TAXUS-IV trial. Similarly, the cost per quality-adjusted life-year gained varied from $243,638 to $263,840 for the SIRIUS trial and from $250,739 to $269,708 for the TAXUS-IV trial. In conclusion, LST-related adverse events and the need for extended clopidogrel therapy substantially increase the costs associated with the implementation of DES. The inclusion of these costs renders the widespread use of DES not cost effective in the United States in terms of cost per quality-adjusted life-year gained and cost per revascularization avoided.

PMID: 19166686 [PubMed - in process]

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Comparison of the sirolimus-eluting versus paclitaxel-eluting coronary stent in patients with diabetes mellitus: the diabetes and drug-eluting stent (DiabeDES) randomized angiography trial.

Am J Cardiol. 2009 Feb 1;103(3):345-9

Authors: Maeng M, Jensen LO, Galloe AM, Thayssen P, Christiansen EH, Hansen KN, Helqvist S, Botker HE, Lassen JF, Thuesen L

The aim of the present study was to evaluate angiographic late luminal loss after the implantation of sirolimus-eluting Cypher stents and paclitaxel-eluting Taxus stents in patients with diabetes. The study was a Danish multicenter, open-label, randomized trial. One hundred fifty-three patients with diabetes with coronary artery disease were randomized to Cypher (n = 76) or Taxus (n = 77) stent implantation. All patients were followed for 8 months. The primary end point was 8-month angiographic in-stent late luminal loss. This primary end point was reduced in the Cypher group compared with the Taxus group (0.23 +/- 0.54 vs 0.44 +/- 0.52 mm, p = 0.025). Angiographic in-segment restenosis at 8-month follow-up, a secondary end point, was present in 16 patients (Cypher, n = 6; Taxus, n = 10; p = 0.24). Target lesion revascularization was performed in 5 patients (6.5%) and 9 patients (11.8%) in the Cypher and Taxus groups, respectively (p = 0.25). Definite stent thrombosis was observed in 2 patients (in the Taxus group), no patients had probable stent thrombosis, and 1 patient in each group had possible stent thrombosis. Major adverse cardiac events (cardiac death, myocardial infarction, definite stent thrombosis, or target lesion revascularization) were observed in 17 patients (Cypher, n = 6; Taxus, n = 11; p = 0.19). In conclusion, angiographic in-stent late luminal loss is significantly reduced in patients with diabetes by use of the sirolimus-eluting Cypher stent compared with the paclitaxel-eluting Taxus stent.

PMID: 19166687 [PubMed - in process]

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Once-a-week rosuvastatin (2.5 to 20 mg) in patients with a previous statin intolerance.

Am J Cardiol. 2009 Feb 1;103(3):393-4

Authors: Ruisinger JF, Backes JM, Gibson CA, Moriarty PM

The purpose of this study was to determine the efficacy of rosuvastatin dosed once a week in patients with a previous statin adverse event. Rosuvastatin once a week was tolerated by 37 (74%) of the 50 study participants, with doses ranging from 2.5 mg to 20 mg a week (mean 10 +/- 4 mg). Patients tolerating the once-a-week regimen experienced a 17% reduction in total cholesterol, 23% reduction in low-density lipoprotein cholesterol, 12% reduction in triglycerides, and a 5% increase in high-density lipoprotein cholesterol (all p <0.001), during a mean follow-up of 4 months +/- 2. Although this alternative dosing regimen has not been proven to reduce cardiovascular events, it may provide a therapeutic option for patients who may otherwise go without the proven benefits of statin therapy. In conclusion, this dosing strategy was well tolerated in patients with a history of an adverse event to 1 or more statins and led to significant lipoprotein changes.

PMID: 19166695 [PubMed - in process]

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Relation of serum sodium level to long-term outcome after a first hospitalization for heart failure with preserved ejection fraction.

Am J Cardiol. 2009 Feb 1;103(3):405-10

Authors: Rusinaru D, Buiciuc O, Leborgne L, Slama M, Massy Z, Tribouilloy C

Hyponatremia is a predictor of adverse short-term outcomes in patients with acute heart failure (HF). The impact of hyponatremia on long-term survival in patients with HF with preserved ejection fraction (HFPEF) has not been evaluated. Our aim was to prospectively assess the impact of baseline natremia and changes in sodium level during hospitalization on 7-year outcome in 358 patients surviving a first hospitalization for HFPEF. On admission, hyponatremia (sodium <136 mEq/L) was diagnosed in 91 patients (25.4%). Baseline hyponatremia was associated with an increased risk of overall (hazard ratio [HR] 1.98, 95% confidence interval [CI] 1.50 to 2.61) and cardiovascular mortality (HR 1.92, 95% CI 1.36 to 2.73). After adjustment for covariates, the relations remained significant. Seven-year relative survival (observed/expected survival) of hyponatremic patients was lower than that of patients with normal baseline natremia (31% vs 63%). The association of sodium and risk of death appeared linear across quartiles of baseline natremia and slightly stronger at the lowest of sodium values. At discharge, 45 patients with low baseline sodium had normal natremia (49%) and 46 had persistent hyponatremia (51%). Patients with normalized natremia at discharge had excess 7-year overall mortality compared with the normonatremic group (HR 1.50, 95% CI 1.03 to 2.19). Patients with persistent hyponatremia had the lowest 7-year survival (HR 2.67, 95% CI 1.89 to 3.78). After adjustment for covariates, patients with persistent hyponatremia had an impressive increase in relative risk of overall mortality compared with patients with normal baseline natremia. In conclusion, hyponatremia is a powerful predictor of long-term mortality in patients with HFPEF. Patients with HFPEF and persistent hyponatremia are at high risk of adverse outcomes.

PMID: 19166698 [PubMed - in process]

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Review of mobile communication devices as potential reservoirs of nosocomial pathogens.

J Hosp Infect. 2009 Jan 23;

Authors: Brady RR, Verran J, Damani NN, Gibb AP

Innovation in mobile communication technology has provided novel approaches to the delivery of healthcare and improvements in the speed and quality of routine medical communication. Bacterial contamination of mobile communication devices (MCDs) could be an important issue affecting the implementation of effective infection control measures and might have an impact on efforts to reduce cross-contamination. This review examines recent studies reporting bacterial contamination of MCDs, most demonstrating that 9-25% of MCDs are contaminated with pathogenic bacteria. We examine previously investigated risk factors for MCD contamination in addition to work on surface decontamination of the device. Recommendations to reduce contamination risks include staff education, strict hand hygiene measures, guidelines on device cleaning and consideration of the restrictions regarding use of mobile phone technology in certain high risk areas, for example, operating theatres, intensive care units and burns units. Further work is required to evaluate the benefit of such interventions on MCD contamination and to determine whether a link exists between contamination and subsequent patient infection.

PMID: 19168261 [PubMed - as supplied by publisher]

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Primary Care Consultations About Medically Unexplained Symptoms: How Do Patients Indicate What They Want?

J Gen Intern Med. 2009 Jan 23;

Authors: Salmon P, Ring A, Humphris GM, Davies JC, Dowrick CF

BACKGROUND: Patients with medically unexplained physical symptoms (MUS) are often thought to deny psychological needs when they consult general practitioners (GPs) and to request somatic intervention instead. We tested predictions from the contrasting theory that they are transparent in communicating their psychological and other needs. OBJECTIVE: To test predictions that what patients tell GPs when they consult about MUS is related transparently to their desire for (1) emotional support, (2) symptom explanation and (3) somatic intervention. DESIGN: Prospective naturalistic study. Before consultation, patients indicated what they wanted from it using a self-report questionnaire measuring patients’ desire for: emotional support, explanation and reassurance, and physical investigation and treatment. Their speech during consultation was audio-recorded, transcribed and coded utterance-by-utterance. Multilevel regression analysis tested relationships between what patients sought and what they said. PARTICIPANTS: Patients (N = 326) consulting 33 GPs about symptoms that the GPs designated as MUS. RESULTS: Patients who wanted emotional support spoke more about psychosocial problems, including psychosocial causes of symptoms and their need for psychosocial help. Patients who wanted explanation and reassurance suggested more physical explanations, including diseases, but did not overtly request explanation. Patients’ wish for somatic intervention was associated only with their talk about details of such interventions and not with their requests for them. CONCLUSIONS: In general, patients with medically unexplained symptoms provide many cues to their desire for emotional support. They are more indirect or guarded in communicating their desire for explanation and somatic intervention.

PMID: 19165548 [PubMed - as supplied by publisher]

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Brushes and picks used on nails during the surgical scrub to reduce bacteria: a randomised trial.

J Hosp Infect. 2009 Jan 20;

Authors: Tanner J, Khan D, Walsh S, Chernova J, Lamont S, Laurent T

Though brushes are no longer used on the hands and forearms during the surgical scrub, they are still widely used on the nails. The aim of this study was to determine whether nail picks and nail brushes are effective in providing additional decontamination during a surgical hand scrub. A total of 164 operating department staff were randomised to undertake one of the following three surgical hand-scrub protocols: chlorhexidine only; chlorhexidine and a nail pick; or chlorhexidine and a nail brush. Bacterial hand sampling was conducted before and 1h after scrubbing using a modified version of the glove juice method. No statistically significant differences in bacterial numbers were found between any two of the three intervention groups. Nail brushes and nail picks used during surgical hand scrubs do not decrease bacterial numbers and are unnecessary.

PMID: 19162371 [PubMed - as supplied by publisher]

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Aerial dispersal of meticillin-resistant Staphylococcus aureus in hospital rooms by infected or colonised patients.

J Hosp Infect. 2009 Jan 20;

Authors: Gehanno JF, Louvel A, Nouvellon M, Caillard JF, Pestel-Caron M

The aim of this study was to assess to what extent patients with meticillin-resistant Staphylococcus aureus (MRSA) at respiratory sites shed viable MRSA into the air of hospital rooms. We also evaluated whether the distance from the patient could influence the level of contamination. Air sampling was performed directly onto MRSA-selective agar in 24 hospital rooms containing patients with MRSA colonization or infection of the respiratory tract. Samplings were performed in duplicate at 0.5, 1 and 2-3m from the patients’ heads. Clinical and environmental isolates were compared using antimicrobial resistance patterns and pulsed-field gel electrophoresis. MRSA strains were isolated from 21 out of 24 rooms, in quantities varying from between 1 and 78cfu/m(3). In each of the 21 rooms, at least one of the environmental isolates was identical to a clinical isolate from the patient in that room. There was no significant difference in MRSA counts between the distance from the patient’s head and the sampler. This study demonstrates that most patients with MRSA infection or colonisation of the respiratory tract shed viable MRSA into the air of their room. The results emphasise the need to study MRSA in air in more detail in order to improve infection control recommendations.

PMID: 19162372 [PubMed - as supplied by publisher]

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Waterlow score to predict patients at risk of developing Clostridium difficile-associated disease.

J Hosp Infect. 2009 Jan 20;

Authors: Tanner J, Khan D, Anthony D, Paton J

This study describes the development and testing of an assessment tool to predict the risk of patients developing Clostridium difficile-associated disease (CDAD). The three phases of the study include the development of the tool, prospective testing of the validity of the tool using 1468 patients in a medical assessment unit and external retrospective testing using data from 29 425 patients. In the first phase of the study, receiver operating characteristic (ROC) analysis identified the Waterlow assessment score as having the ability to predict CDAD (area under the curve: 0.827). The Waterlow tool was then tested prospectively with 1468 patients admitted to a medical assessment unit. A total of 1385 patients (94%) had a Waterlow score <20 and 83 patients (6%) had a Waterlow score of >/=20. After a three-month follow-up, six patients in the low Waterlow score group developed CDAD (0.4%) and 14 patients in the high score group developed CDAD (17%). The sensitivity and specificity of the Waterlow score to predict the risk of developing CDAD were 70% and 95%, respectively. Similar results were obtained when the tool was tested retrospectively on a large external patient data set. The Waterlow score appears to predict patients' risk of developing CDAD and although it did not identify all cases, it highlighted a small group of patients who had a disproportionately large number of CDAD cases. The Waterlow score can be used to target patients most at risk of developing CDAD.

PMID: 19162374 [PubMed - as supplied by publisher]

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B-type natriuretic peptide in acute pulmonary embolism.

Clin Chim Acta. 2008 Dec;398(1-2):1-4

Authors: Kaczy?ska A, Kostrubiec M, Ciurzy?ski M, Pruszczyk P

Myocardial stretch leads to the natriuretic peptides release in acute or chronic left ventricular dysfunction. However, there is an accumulating evidence that B-type natriuretic peptide (BNP) and its N-terminal fragment (NT-proBNP) may originate from right ventricle and their concentrations are elevated in patients with acute pulmonary embolism (APE) especially when resulting in right ventricular dysfunction (RVD). Recently it is underlined that severity assessment of APE as well as the risk stratification and therapy selection is based both on patients’ hemodynamic status and markers of myocardial injury and RVD. BNP and NT-proBNP are helpful in identifying patients with RVD in APE, emerging as an adjunctive tool to echocardiography. Elevated BNP or NT-proBNP levels are also significant predictors of death and/or complicated clinical course in APE.

PMID: 18706401 [PubMed - indexed for MEDLINE]

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The use of intravenous enoxaparin in elective percutaneous coronary intervention in patients with renal impairment: results from the SafeTy and Efficacy of Enoxaparin in PCI patients, an internationaL randomized Evaluation (STEEPLE) trial.

Am Heart J. 2009 Jan;157(1):125-31

Authors: White HD, Gallo R, Cohen M, Steg PG, Aylward PE, Bode C, Steinhubl S, Montalescot G

BACKGROUND: The STEEPLE trial assessed outcomes of patients undergoing elective percutaneous coronary intervention randomized to receive a bolus of intravenous enoxaparin (0.5 or 0.75 mg/kg, n = 2,298) or activated clotting time-adjusted unfractionated heparin (UFH, n = 1,230), stratified according to planned glycoprotein IIb/IIIa inhibitor use. METHODS: In this subanalysis, we assessed outcomes in patients with renal impairment (creatinine clearance < or =60 mL/min, n = 659). RESULTS: Major bleeding occurred more often in patients with renal impairment compared with those without (2.7% vs 1.5%, P = .04). Enoxaparin was associated with less major bleeding than UFH with normal renal function (0.9% for enoxaparin 0.5 mg/kg or 1.0% for enoxaparin 0.75 mg/kg vs 2.6%, respectively; both P = .01 vs UFH), with a trend toward less major bleeding with impaired renal function (2.6% or 1.8% vs 3.8%, P = .18 for enoxaparin 0.5 mg/kg and P = .47 for 0.75 mg/kg vs UFH). Minor bleeding rates were similar irrespective of renal function or anticoagulation regimen. The incidence of death, nonfatal myocardial infarction, or urgent target-vessel revascularization was similar between patients with and without renal impairment (5.7% vs 6.5%, P = .45). In patients with renal impairment, event rates were 6.2% or 5.3% with enoxaparin vs 5.6% with UFH (P = nonsignificant). Target anticoagulation levels were achieved 4 to 5 times more often with enoxaparin compared with UFH in patients with normal and impaired renal function (both P < .0001). CONCLUSIONS: A single bolus of enoxaparin was associated with similar ischemic events and a trend for less major bleeding compared with UFH in patients with renal impairment undergoing percutaneous coronary intervention. Enoxaparin can be administered safely without dose adjustment in these patients.

PMID: 19081408 [PubMed - indexed for MEDLINE]

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Should all patients be told about sudden unexpected death in epilepsy (SUDEP)? Pros and Cons.

Epilepsia. 2008 Dec;49 Suppl 9:99-101

Authors: Brodie MJ, Holmes GL

Despite being a relatively rare event, sudden unexpected death in epilepsy (SUDEP) can tragically cut short a young person’s life, particularly if seizures are not well controlled or when concordance with the antiepileptic drug regimen is less than optimal. Both the Scottish Intercollegiate Guidelines Network (SIGN) and the UK National Institute of Clinical Excellence (NICE) recommend universal discussion of SUDEP and support the view of one of the authors (MJB) and that of the Joint Epilepsy Council of UK charities that patients and their families have the right to know about the risks of epilepsy and the reasons for treatment. However, the risk of SUDEP is not uniform across all patient populations. Most people with newly diagnosed epilepsy will stop having seizures, and SUDEP is very rare among them. The highest risk groups are those with a young age of onset, frequent generalized tonic-clonic seizures, and medical intractability. The mechanisms underlying SUDEP are unclear, and there are no effective preventative therapies. It is the contention of the other author (GLH) that it is not necessary, or advisable, to discuss SUDEP with all patients. Rather, he contends that SUDEP should be discussed only with those patients who are at high risk. In particular, patients who have generalized tonic-clonic seizures and who are non-compliant with antiepileptic drugs should be counseled about their risk-taking behavior. Both authors agree that additional studies into the pathophysiology and prevention of SUDEP are urgently needed.

PMID: 19087124 [PubMed - indexed for MEDLINE]

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Hand hygiene in the intensive care unit: prospective observations of clinical practice.

Pol Arch Med Wewn. 2008 Oct;118(10):543-7

Authors: Qushmaq IA, Heels-Ansdell D, Cook DJ, Loeb MB, Meade MO

INTRODUCTION: Adherence to hand hygiene recommendations in the intensive care unit (ICU) is variable and moderate, at best. OBJECTIVES: To measure adherence to hand hygiene recommendations among ICU clinicians in a prospective observational study in 6 multidisciplinary ICUs among 4 hospitals. PATIENTS AND METHODS: We observed 115 clinicians (64 nurses, 21 respiratory therapists, 18 residents and 12 physicians) during 1 patient encounter, each. Clinicians were unaware that they were under observation. We documented use of gloves, soap, and alcohol solution before and after patient encounters for purposes of physical examination or patient care. RESULTS: The rate of adherence to current recommendations was 20% (95% CI 13.7-28.2). All 23 clinicians adhering to recommendations used gloves followed by washing with soap or alcohol solution. 57.4% (95% CI 48.3-66.0) of clinicians used some form of hand hygiene without fully adhering to recommendations, whereas 42.6% did not appear to attend to hand hygiene at all during observation. By univariate analysis, with nurses as the reference group, we found trends suggesting lowest adherence rates among residents (odds ratio [OR] 0.32, 95% CI 0.11-0.96) and intensivists (OR 0.46, 95% CI, 0.13-1.60), and highest adherence among respiratory therapists (OR 2.05, 95% CI 0.67-6.30). We also observed a center effect (p = 0.04). However, multivariate analysis showed no relationship of hand hygiene to clinician group (p = 0.06) nor ICU (p = 0.05). CONCLUSIONS: Multidisciplinary, multimethod approaches to improving hand hygiene are likely necessary to improve the modest adherence to hand hygiene that we observed.

PMID: 19112814 [PubMed - indexed for MEDLINE]

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Long-term results of carotid artery stenting.

J Vasc Surg. 2008 Dec;48(6):1431-40; discussion 1440-1

Authors: de Donato G, Setacci C, Deloose K, Peeters P, Cremonesi A, Bosiers M

OBJECTIVE: Data regarding the long-term efficacy of carotid artery stenting (CAS) are still scarce. As demonstrated by several major randomized controlled trials (RCT) comparing the efficacy of carotid endarterectomy (CEA) vs medical therapy, even after successful carotid revascularization late ipsilateral stroke occurs in 5-13% at 5 years. Therefore, major concerns also remain about the durability of the CAS procedure in terms of stroke prevention. The purpose of this study was to review long-term results after carotid stent implantation in a large cohort of patients. METHODS: This retrospective investigation involved 3179 CAS procedures performed at four European carotid high-volume centers. Echo-duplex scan using modified velocity criteria to recognize in-stent restenosis (ISR) and neurological examinations of all patients were carried out every 6 months after the procedure. Life-table analysis was used to determine freedom from mortality, stroke-related death, ipsilateral fatal/major stroke, and any ipsilateral stroke. Freedom from ISR and from reintervention were also reported. The secondary aim was to identify predictive risk factors for neurological complications and ISR. RESULTS: At 5 years freedom from mortality, stroke-related death, ipsilateral fatal/major stroke, and any stroke rate were 82%, 93.5%, 93.3%, and 91.9%, respectively. The only predictor for neurological complications was the presence of neurological symptoms before CAS (hazard ratio 1.38 [CI 1.05, 1.82] P = .02). Freedom from restenosis at 1, 3, and 5 years was, respectively, 98.4%, 96.1%, and 94%. Uni- and multi-variate analyses showed that stent characteristics (material/design/free-cell area) were not significantly associated with time to in-stent restenosis or time to reintervention. CONCLUSION: Our long-term results in a large cohort of patients validated CAS as a durable procedure for stroke prevention. The annual rate of neurological complications after CAS was comparable to that of conventional surgery as demonstrated by large RCTs involving both symptomatic patients (North American Symptomatic Carotid Endarterectomy Trial [NASCET] and European Carotid Surgery Trial [ECST]) and asymptomatic patients (Asymptomatic Carotid Atherosclerosis Study [ACAS] and Asymptomatic Carotid Surgery Trial [ACST]).

PMID: 18848755 [PubMed - indexed for MEDLINE]

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