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<1>
Accession Number
2012013528
Authors
Whitlow P.L. Feldman T. Pedersen W.R. Lim D.S. Kipperman R. Smalling R.
Bajwa T. Herrmann H.C. Lasala J. Maddux J.T. Tuzcu M. Kapadia S. Trento A.
Siegel R.J. Foster E. Glower D. Mauri L. Kar S.
Institution
(Whitlow, Tuzcu, Kapadia) Department of Cardiovascular Medicine, J2-3,
Cleveland Clinic, 9500 Euclid Avenue, Cleveland, OH 44195, United States
(Feldman) Northshore University Health System, Chicago, IL, United States
(Pedersen) Minneapolis Heart Institute and Foundation, Minneapolis, MN,
United States
(Lim) University of Virginia, Charlottesville, VA, United States
(Kipperman) Oklahoma Heart Hospital, Oklahoma City, OK, United States
(Smalling) Memorial Hermann Heart and Vascular Institute, Houston, TX,
United States
(Bajwa) Aurora Health Center, West Bend, WI, United States
(Herrmann) University of Pennsylvania, Philadelphia, PA, United States
(Lasala) Washington University, St. Louis, MO, United States
(Maddux) International Heart Institute of Montana, Missoula, MT, United
States
(Trento, Siegel, Kar) Cedars-Sinai Medical Center, Los Angeles, CA, United
States
(Foster) University of California, San Francisco, San Francisco, CA,
United States
(Glower) Duke University Medical Center, Durham, NC, United States
(Mauri) Brigham and Women's Hospital, Harvard Medical School, Boston, MA,
United States
Title
Acute and 12-month results with catheter-based mitral valve leaflet
repair: The EVEREST II (Endovascular Valve Edge-to-Edge Repair) High Risk
Study.
Source
Journal of the American College of Cardiology. 59 (2) (pp 130-139), 2012.
Date of Publication: 10 Jan 2012.
Publisher
Elsevier USA (6277 Sea Harbor Drive, Orlando FL 32862 8239, United States)
Abstract
Objectives: The EVEREST II (Endovascular Valve Edge-to-Edge Repair) High
Risk Study (HRS) assessed the safety and effectiveness of the MitraClip
device (Abbott Vascular, Santa Clara, California) in patients with
significant mitral regurgitation (MR) at high risk of surgical mortality
rate. Background: Patients with severe MR (3 to 4+) at high risk of
surgery may benefit from percutaneous mitral leaflet repair, a potentially
safer approach to reduce MR. Methods: Patients with severe symptomatic MR
and an estimated surgical mortality rate of >=12% were enrolled. A
comparator group of patients screened concurrently but not enrolled were
identified retrospectively and consented to compare survival in patients
treated by standard care. Results: Seventy-eight patients underwent the
MitraClip procedure. Their mean age was 77 years, >50% had previous
cardiac surgery, and 46 had functional MR and 32 degenerative MR.
MitraClip devices were successfully placed in 96% of patients.
Protocol-predicted surgical mortality rate in the HRS and concurrent
comparator group was 18.2% and 17.4%, respectively, and Society of
Thoracic Surgeons calculator estimated mortality rate was 14.2% and 14.9%,
respectively. The 30-day procedure-related mortality rate was 7.7% in the
HRS and 8.3% in the comparator group (p = NS). The 12-month survival rate
was 76% in the HRS and 55% in the concurrent comparator group (p = 0.047).
In surviving patients with matched baseline and 12-month data, 78% had an
MR grade of <=2+. Left ventricular end-diastolic volume improved from 172
ml to 140 ml and end-systolic volume improved from 82 ml to 73 ml (both p
= 0.001). New York Heart Association functional class improved from III/IV
at baseline in 89% to class I/II in 74% (p < 0.0001). Quality of life was
improved (Short Form-36 physical component score increased from 32.1 to
36.1 [p = 0.014] and the mental component score from 45.5 to 48.7 [p =
0.065]) at 12 months. The annual rate of hospitalization for congestive
heart failure in surviving patients with matched data decreased from 0.59
to 0.32 (p = 0.034). Conclusions: The MitraClip device reduced MR in a
majority of patients deemed at high risk of surgery, resulting in
improvement in clinical symptoms and significant left ventricular reverse
remodeling over 12 months. (Pivotal Study of a Percutaneous Mitral Valve
Repair System [EVEREST II]; NCT00209274). 2012 by the American College of
Cardiology Foundation.

<2>
Accession Number
2012035869
Authors
Fernandez-Sabe N. Cervera C. Farinas M.C. Bodro M. Munoz P. Gurgui M.
Torre-Cisneros J. Martin-Davila P. Noblejas A. Len O. Garcia-Reyne A. Del
Pozo J.L. Carratala J.
Institution
(Fernandez-Sabe, Bodro, Carratala) Infectious Disease Service, Institut
d'Investigacio Biomedica de Bellvitge (IDIBELL), Hospital Universitari de
Bellvitge, Feixa Llarga s/n, 08907 L'Hospitalet, Barcelona, Spain
(Cervera) Infectious Disease Service, Hospital Clinic, University of
Barcelona, Spain
(Farinas) Infectious Disease Unit, Hospital Universitario Marques de
Valdecilla, University of Cantabria, Santander, Spain
(Munoz) Department of Clinical Microbiology and Infectious Diseases,
Hospital General Universitario Gregorio Maranon, Universidad Complutense
de Madrid, Spain
(Gurgui) Infectious Disease Unit, Hospital de la Santa Creu i Sant Pau,
Universitat Autonoma de Barcelona, Spain
(Torre-Cisneros) Unidad Clinica de Enfermedades Infecciosas, Hospital
Universitario Reina Sofia-IMIBIC, Universidad de Cordoba, Spain
(Martin-Davila) Department of Infectious Diseases, Hospital Universitario
Ramon y Cajal, Spain
(Noblejas) Transplant Department, Hospital Universitario Puerta de Hierro,
Madrid, Spain
(Len) Infectious Disease Service, Hospital Universitari Vall d'Hebron,
Barcelona, Spain
(Garcia-Reyne) Infectious Disease Unit, Hospital Universitario 12 de
Octubre, Madrid, Spain
(Del Pozo) Infectious Diseases Division, Clinica Universidad de Navarra,
Spain
Title
Risk factors, clinical features, and outcomes of toxoplasmosis in
solid-organ transplant recipients: A matched case-control study.
Source
Clinical Infectious Diseases. 54 (3) (pp 355-361), 2012. Date of
Publication: 01 Feb 2012.
Publisher
Oxford University Press (2001 Evans Road, Cary NC 27513, United States)
Abstract
Background. Solid-organ transplant (SOT) recipients are considered to be
at increased risk for toxoplasmosis. However, risk factors for this
infection have not been assessed. The aim of this study was to determine
the risk factors, clinical features, and outcomes of toxoplasmosis in SOT
recipients. Methods. A multicenter, matched case-control study (1:2 ratio)
was conducted between 2000 and 2009. Control subjects were matched for
center, transplant type, and timing. Cases were identified from the
hospitals' microbiology and transplantation program databases. Logistic
regression was performed to identify independent risk factors. Results.
Twenty-two cases (0.14%) of toxoplasmosis were identified among 15 800
SOTs performed in 11 Spanish hospitals, including 12 heart, 6 kidney, and
4 liver recipients. Diagnosis was made by seroconversion (n = 17),
histopathologic examination (n = 5), polymerase chain reaction (n = 2),
and autopsy (n = 2). In a comparison of case patients with 44 matched
control subjects, a negative serostatus prior to transplantation was the
only independent risk factor for toxoplasmosis (odds ratio, 15.12 [95%
confidence interval, 2.37-96.31]; P =. 004). The median time to diagnosis
following transplantation was 92 days. Primary infection occurred in 18
(81.8%) cases. Manifestations included pneumonitis (n = 7), myocarditis (n
= 5), brain abscesses (n = 5), chorioretinitis (n = 3), lymph node
enlargement (n = 2), hepatosplenomegaly (n = 2), and meningitis (n =1).
Five patients (22.7%) had disseminated disease. Crude mortality rate was
13.6% (3 of 22 patients). Conclusions. Although uncommon, toxoplasmosis in
SOT patients causes substantial morbidity and mortality. Seronegative
recipients are at high risk for developing toxoplasmosis and should be
given prophylaxis and receive careful follow-up. The Author 2011.
Published by Oxford University Press on behalf of the Infectious.

<3>
Accession Number
2012033138
Authors
Nojiri T. Yamamoto K. Maeda H. Takeuchi Y. Funakoshi Y. Inoue M. Okumura
M.
Institution
(Nojiri, Maeda, Takeuchi, Funakoshi) Department of General Thoracic
Surgery, Toneyama National Hospital, Toneyama 5-1-1, Toyonaka City
560-8552, Osaka, Japan
(Nojiri, Inoue, Okumura) Department of General Thoracic Surgery, Osaka
University, Graduate School of Medicine, Suita-City, Japan
(Yamamoto) Department of Cardiology, Osaka University, Graduate School of
Medicine, Suita-City, Japan
Title
Effect of low-dose human atrial natriuretic peptide on postoperative
atrial fibrillation in patients undergoing pulmonary resection for lung
cancer: A double-blind, placebo-controlled study.
Source
Journal of Thoracic and Cardiovascular Surgery. 143 (2) (pp 488-494),
2012. Date of Publication: February 2012.
Publisher
Mosby Inc. (11830 Westline Industrial Drive, St. Louis MO 63146, United
States)
Abstract
Objectives: We previously reported that patients with preoperative B-type
natriuretic peptide levels of 30 pg/mL or more have increased risk of
postoperative atrial fibrillation after pulmonary resection. This study
evaluated the effects of human atrial natriuretic peptide on postoperative
atrial fibrillation in patients undergoing pulmonary resection for lung
cancer. Methods: A prospective, randomized study was conducted with 40
patients who had preoperative elevated B-type natriuretic peptide (>=30
pg/mL) and underwent a scheduled pulmonary resection for lung cancer.
Results were compared between patients who received low-dose human atrial
natriuretic peptide and those who received a placebo. The primary end
point was the incidence of postoperative atrial fibrillation during the
first 4 days after surgery. Results: The incidence of postoperative atrial
fibrillation was significantly lower in the human atrial natriuretic
peptide group than in the placebo group (10% vs 60%; P < .001). Patients
in the human atrial natriuretic peptide group also showed significantly
lower white blood cell counts and C-reactive protein levels after surgery.
Conclusions: Continuous infusion of low-dose human atrial natriuretic
peptide during lung cancer surgery had a prophylactic effect against
postoperative atrial fibrillation after pulmonary resection in patients
with preoperative elevation of B-type natriuretic peptide levels. A larger
sample size is needed to establish the safety and efficacy of this
intervention. 2012 by The American Association for Thoracic Surgery.

<4>
Accession Number
2012033160
Authors
Desai S.P. Henry L.L. Holmes S.D. Hunt S.L. Martin C.T. Hebsur S. Ad N.
Institution
(Desai, Henry, Holmes, Hunt, Martin, Hebsur, Ad) Inova Heart and Vascular
Institute, 3300 Gallows Road, Falls Church, VA 22042, United States
Title
Strict versus liberal target range for perioperative glucose in patients
undergoing coronary artery bypass grafting: A prospective randomized
controlled trial.
Source
Journal of Thoracic and Cardiovascular Surgery. 143 (2) (pp 318-325),
2012. Date of Publication: February 2012.
Publisher
Mosby Inc. (11830 Westline Industrial Drive, St. Louis MO 63146, United
States)
Abstract
Objective: The purpose of this study was to test the hypothesis that a
liberal blood glucose strategy (121-180 mg/dL) is not inferior to a strict
blood glucose strategy (90-120 mg/dL) for outcomes in patients after
first-time isolated coronary artery bypass grafting and is superior for
glucose control and target blood glucose management. Methods: A total of
189 patients undergoing coronary artery bypass grafting were investigated
in this prospective randomized study to compare 2 glucose control
strategies on patient perioperative outcomes. Three methods of analyses
(intention to treat, completer, and per protocol) were conducted. Observed
power was robust (>80%) for significant results. Results: The groups were
similar on preoperative hemoglobin A _1c and number of diabetic
patients. The liberal group was found to be noninferior to the strict
group for perioperative complications and superior on glucose control and
target range management. The liberal group had significantly fewer
patients with hypoglycemic events (<60 mg/dL; P < .001), but severe
hypoglycemic events (<40 mg/dL) were rare and no group differences were
found (P = .23). These results were found with all 3 methods of analysis
except for blood glucose variability, maximum blood glucose, and
perioperative atrial fibrillation. Conclusions: This study demonstrated
that maintenance of blood glucose in a liberal range after coronary artery
bypass grafting led to similar outcomes compared with a strict target
range and was superior in glucose control and target range management. On
the basis of the results of this study, a target blood glucose range of
121 to 180 mg/dL is recommended for patients after coronary artery bypass
grafting as advocated by the Society of Thoracic Surgeons. 2012 by The
American Association for Thoracic Surgery.

<5>
Accession Number
2012033153
Authors
Lee H.J. Kim Y.T. Park P.J. Shin Y.S. Kang K.N. Kim Y. Kim C.W.
Institution
(Lee, Kim) Department of Molecular Oncology, Cancer Research Institute,
Seoul National University, Seoul, South Korea
(Lee) National Evidence-Based Healthcare Collaborating Agency, Seoul,
South Korea
(Kim) Department of Thoracic and Cardiovascular Surgery, Clinical Research
Institute, Seoul National University Hospital, Seoul, South Korea
(Park, Shin, Kang) Bioinfra Inc, Cancer Research Institute, Seoul National
University, Seoul, South Korea
(Kim) Department of Statistics, Seoul National University, Seoul, South
Korea
(Kim) Department of Pathology, Cancer Research Institute, Seoul National
University, Seoul, South Korea
Title
A novel detection method of non-small cell lung cancer using multiplexed
bead-based serum biomarker profiling.
Source
Journal of Thoracic and Cardiovascular Surgery. 143 (2) (pp 421-427),
2012. Date of Publication: February 2012.
Publisher
Mosby Inc. (11830 Westline Industrial Drive, St. Louis MO 63146, United
States)
Abstract
Objectives: Non-small cell lung cancer (NSCLC) is the leading cause of
cancer-related mortality. Development of an early diagnosis method may
improve survivals. We aimed to develop a new diagnostic model for NSCLC
using serum biomarkers. Methods: We set up a patient group diagnosed with
NSCLC (n = 122) and a healthy control group (n = 225). Thirty serum
analytes were selected on the basis of previous studies and a literature
search. An antibody-bead array of 30 markers was constructed using the
Luminex bead array platform (Luminex Inc, Austin, Tex) and was analyzed.
Each marker was ranked by importance using the random forest method and
then selected. Using selected markers, multivariate classification
algorithms were constructed and were validated by application to
independent validation cohort of 21 NSCLC and 28 control subjects.
Results: There was no difference in demographics between patients and the
control population except for age (64.8 +/- 10.0 for patients vs 53.0 +/-
7.6 years for the control group). Among the 30 serum proteins, 23 showed a
difference between the 2 groups (12 increased and 11 decreased in the
patient group). We found the highest accuracy of multivariate
classification algorithms when using the 5 highest-ranked biomarkers
(A1AT, CYFRA 21-1, IGF-1, RANTES, AFP). When we applied the algorithms on
a validation cohort, each method recognized the patients from the controls
with high accuracy (89.8% with random forest, 91.8% with support vector
machine, 88.2% with linear discriminant analysis, and 90.5% with logistic
regression). Conclusions: We confirmed that a new diagnostic method using
5 serum biomarkers profiling constructed by multivariate classification
algorithms could distinguish NSCLC from healthy controls with high
accuracy. 2012 by The American Association for Thoracic Surgery.

<6>
Accession Number
2012041563
Authors
van Loon R.B. Veen G. Baur L.H.B. Kamp O. Bronzwaer J.G.F. Twisk J.W.R.
Verheugt F.W.A. van Rossum A.C.
Institution
(van Loon, Veen, Kamp, Bronzwaer, van Rossum) Department of Cardiology, VU
University Medical Center, Amsterdam, Netherlands
(Baur) Department of Cardiology, Atrium Medical Center Parkstad, Heerlen
and Faculty of Health, Medicine and Life Sciences, University Maastricht,
Netherlands
(Twisk) Department of Clinical Epidemiology and Biostatistics, VU
University Medical Center, Amsterdam, Netherlands
(Verheugt) Heartcenter, University Medical Center, St Radboud, Nijmegen,
Netherlands
Title
Improved clinical outcome after invasive management of patients with
recent myocardial infarction and proven myocardial viability: Primary
results of a randomized controlled trial (VIAMI-trial).
Source
Trials. 13 , 2012. Article Number: 1. Date of Publication: 03 Jan
2012.
Publisher
BioMed Central Ltd. (Floor 6, 236 Gray's Inn Road, London WC1X 8HB, United
Kingdom)
Abstract
Background: Patients with ST-elevation myocardial infarction (STEMI) not
treated with primary or rescue percutaneous coronary intervention (PCI)
are at risk for recurrent ischemia, especially when viability in the
infarct-area is present. Therefore, an invasive strategy with PCI of the
infarct-related coronary artery in patients with viability would reduce
the occurrence of a composite end point of death, reinfarction, or
unstable angina (UA).Methods: Patients admitted with an (sub)acute
myocardial infarction, who were not treated by primary or rescue PCI, and
who were stable during the first 48 hours after the acute event, were
screened for the study. Eventually, we randomly assigned 216 patients with
viability (demonstrated with low-dose dobutamine echocardiography) to an
invasive or a conservative strategy. In the invasive strategy stenting of
the infarct-related coronary artery was intended with abciximab as adjunct
treatment. Seventy-five (75) patients without viability served as registry
group. The primary endpoint was the composite of death from any cause,
recurrent myocardial infarction (MI) and unstable angina at one year. As
secondary endpoint the need for (repeat) revascularization procedures and
anginal status were recorded.Results: The primary combined endpoint of
death, recurrent MI and unstable angina was 7.5% (8/106) in the invasive
group and 17.3% (19/110) in the conservative group (Hazard ratio 0.42; 95%
confidence interval [CI] 0.18-0.96; p = 0.032). During follow up
revascularization-procedures were performed in 6.6% (7/106) in the
invasive group and 31.8% (35/110) in the conservative group (Hazard ratio
0.18; 95% CI 0.13-0.43; p < 0.0001). A low rate of recurrent ischemia was
found in the non-viable group (5.4%) in comparison to the
viable-conservative group (14.5%). (Hazard-ratio 0.35; 95% CI 0.17-1.00; p
= 0.051).Conclusion: We demonstrated that after acute MI (treated with
thrombolysis or without reperfusion therapy) patients with viability in
the infarct-area benefit from a strategy of early in-hospital stenting of
the infarct-related coronary artery. This treatment results in a long-term
uneventful clinical course. The study confirmed the low risk of recurrent
ischemia in patients without viability. Trial registration:
ClinicalTrials.gov: NCT00149591. 2012 van Loon et al; licensee BioMed
Central Ltd.

<7>
Accession Number
22253393
Authors
Angiolillo D.J. Firstenberg M.S. Price M.J. Tummala P.E. Hutyra M. Welsby
I.J. Voeltz M.D. Chandna H. Ramaiah C. Brtko M. Cannon L. Dyke C. Liu T.
Montalescot G. Manoukian S.V. Prats J. Topol E.J. BRIDGE Investigators
Institution
(Angiolillo) Department of Cardiology, University of Florida,
Jacksonville, USA.
Title
Bridging antiplatelet therapy with cangrelor in patients undergoing
cardiac surgery: a randomized controlled trial.
Source
JAMA : the journal of the American Medical Association. 307 (3) (pp
265-274), 2012. Date of Publication: 18 Jan 2012.
Abstract
Thienopyridines are among the most widely prescribed medications, but
their use can be complicated by the unanticipated need for surgery.
Despite increased risk of thrombosis, guidelines recommend discontinuing
thienopyridines 5 to 7 days prior to surgery to minimize bleeding. To
evaluate the use of cangrelor, an intravenous, reversible P2Y(12) platelet
inhibitor for bridging thienopyridine-treated patients to coronary artery
bypass grafting (CABG) surgery. Prospective, randomized, double-blind,
placebo-controlled, multicenter trial, involving 210 patients with an
acute coronary syndrome (ACS) or treated with a coronary stent and
receiving a thienopyridine awaiting CABG surgery to receive either
cangrelor or placebo after an initial open-label, dose-finding phase (n =
11) conducted between January 2009 and April 2011. Interventions
Thienopyridines were stopped and patients were administered cangrelor or
placebo for at least 48 hours, which was discontinued 1 to 6 hours before
CABG surgery. The primary efficacy end point was platelet reactivity
(measured in P2Y(12) reaction units [PRUs]), assessed daily. The main
safety end point was excessive CABG surgery-related bleeding. The dose of
cangrelor determined in 10 patients in the open-label stage was 0.75
mug/kg per minute. In the randomized phase, a greater proportion of
patients treated with cangrelor had low levels of platelet reactivity
throughout the entire treatment period compared with placebo (primary end
point, PRU <240; 98.8% (83 of 84) vs 19.0% (16 of 84); relative risk [RR],
5.2 [95% CI, 3.3-8.1] P < .001). Excessive CABG surgery-related bleeding
occurred in 11.8% (12 of 102) vs 10.4% (10 of 96) in the cangrelor and
placebo groups, respectively (RR, 1.1 [95% CI, 0.5-2.5] P = .763). There
were no significant differences in major bleeding prior to CABG surgery,
although minor bleeding episodes were numerically higher with cangrelor.
Among patients who discontinue thienopyridine therapy prior to cardiac
surgery, the use of cangrelor compared with placebo resulted in a higher
rate of maintenance of platelet inhibition. clinicaltrials.gov Identifier:
NCT00767507.

<8>
Accession Number
2012028337
Authors
Yazici D. Tas S. Emir H. Sunar H.
Institution
(Yazici) Sub-department of Endocrinology and Metabolism, Department of
Internal Medicine, School of Medicine, Marmara University, Istanbul,
Turkey
(Tas, Sunar) Cardiac and Vascular Surgery Clinic, Kartal Kosuyolu
Education and Research Hospital, Istanbul, Turkey
(Emir) Diabetes Education Nurse, Kartal Education and Research Hospital,
Istanbul, Turkey
Title
A Comparison of preprandial mixed insulin given three times daily and
basal-bolus insulin therapy started postoperatively on patients having
coronary artery bypass graft surgery.
Source
Marmara Medical Journal. 25 (1) (pp 16-19), 2012. Date of Publication:
2012.
Publisher
Marmara University (Haydarpasa, Istanbul, Turkey)
Abstract
Objective: Insulin therapy initiated after coronary artery bypass graft
(CABG) surgery has decreased long-term mortality. The aim was to compare
the effectiveness of prandial premixed therapy (PPT) using insulin thrice
daily and basal-bolus therapy (BBT) on patients having CABG surgery.
Patients and Methods: Thirty-four patients having CABG surgery were
included. Fasting blood glucose (FBG), postprandial blood glucose (PPBG),
hemoglobin A1c (HbA1c) and hemoglobin levels were determined
preoperatively and at the first week postoperatively when the patients
were randomized to either PPT or BBT. Initial measurements were repeated
at the end of three months. Results: Seventeen patients (F/M:9/8;
61.5+/-8.5 years) were assigned on a random basis to the mixed insulin arm
and 17 patients (F/M:10/7; 57.4+/-9.2 years) to the basal-bolus arm. FBG,
PPBG and HbA1c levels of both groups (7.6+/-0.8 % vs 6.7+/-0.5 % in the
BBT and 7.3+/-0.7 % vs 7.3+/-1.0 % in the PPT group) at the end of the 3
months were not different than at the time of randomization. The
percentage of patients reaching HbA1c levels below 6.0%, 6.5% and 7.0%
were higher in the BBT group compared to the PPT group. Conclusion: For
patients who had undergone CABG surgery, BBT provided more patients with
HbA1c levels below the target than did PPT. Marmara Medical Journal,
Published by Galenos Publishing.

<9>
Accession Number
2012031984
Authors
De Luca G. Iorio S. Venegoni L. Marino P.
Institution
(De Luca, Iorio, Venegoni, Marino) Division of Cardiology, Azienda
Ospedaliera-Universitaria Maggiore della Carit, Eastern Piedmont
University, Novara, Italy
Title
Evaluation of intracoronary adenosine to prevent periprocedural
myonecrosis in elective percutaneous coronary intervention (from the
PREVENT-ICARUS trial).
Source
American Journal of Cardiology. 109 (2) (pp 202-207), 2012. Date of
Publication: 15 Jan 2012.
Publisher
Elsevier Inc. (360 Park Avenue South, New York NY 10010, United States)
Abstract
Great interest has focused on pharmacotherapy to prevent periprocedural
myocardial injury during elective percutaneous coronary intervention
(PCI). The aim of the present trial was to investigate the benefits of
preprocedural intracoronary administration of high-dose adenosine during
elective PCI. This was a single-center, double-blind, randomized trial of
patients undergoing elective PCI. The patients were randomized (1:1) by
sealed envelops to intracoronary adenosine (120 mug for the right coronary
artery and 180 mug for the left coronary artery) or placebo. The primary
study end point was a periprocedural increase in troponin I >3 times the
upper limit of normal. The secondary study end points were (1) the
corrected Thrombolysis In Myocardial Infarction frame count; (2) troponin
I release >10 times the upper limit of normal; (3) creatine kinase-MB mass
release <3 times the upper limit of normal; and (4) the combined
cumulative incidence of in-hospital death, periprocedural myocardial
infarction, and in-hospital urgent target vessel revascularization. The
safety end point was the occurrence of bradycardia and ventricular
arrhythmias during study drug administration. From November 2009 to
September 2010, we randomized 260 patients who were undergoing elective
PCI to intracoronary adenosine (n = 130) or placebo (n = 130). A greater
prevalence of calcified lesions was observed in the adenosine group (p =
0.002). In contrast, a greater prevalence of type C lesions (p = 0.091),
chronic occlusions (p = 0.015), worse preprocedural Thrombolysis In
Myocardial Infarction flow (p = 0.038), and more severely stenotic lesions
(p = 0.005) were observed in the placebo group. No difference was found in
the primary (67.7% vs 70%, p = 0.69) or secondary end points. No serious
side effects were observed with adenosine. In conclusion, our randomized
trial showed that preprocedural intracoronary administration of a single
high-dose bolus of adenosine does not provide any benefit in terms of
periprocedural myonecrosis in patients undergoing elective PCI. 2012
Elsevier Inc.

EMBASE Cardiac Update AutoAlert: EPICORE Cardiac Surgery Blogger2

Total documents retrieved: 14

Results Generated From:
Embase <1980 to 2012 Week 03>
Embase (updates since 2012-01-12)

<1>
[Use Link to view the full text]
Accession Number
2012014641
Authors
Heusch G. Musiolik J. Kottenberg E. Peters J. Jakob H. Thielmann M.
Institution
(Heusch, Musiolik) Institut fur Pathophysiologie, Universitatsklinikum
Essen, Hufelandstr 55, 45122 Essen, Germany
(Kottenberg, Peters) Klinik fur Anasthesiologie und Intensivmedizin,
Universitatsklinikum Essen, Essen, Germany
(Jakob, Thielmann) Klinik fur Thorax- und Kardiovaskulare Chirurgie,
Universitatsklinikum Essen, Essen, Germany
Title
STAT5 activation and cardioprotection by remote ischemic preconditioning
in humans.
Source
Circulation Research. 110 (1) (pp 111-115), 2012. Date of Publication:
06 Jan 2012.
Publisher
Lippincott Williams and Wilkins (530 Walnut Street,P O Box 327,
Philadelphia PA 19106-3621, United States)
Abstract
Rationale: The heart can be protected from infarction by brief episodes of
ischemia/reperfusion of a remote organ. Remote ischemic preconditioning
(RIPC) by brief arm ischemia/reperfusion has been recruited in patients
undergoing coronary artery bypass surgery or percutaneous coronary
interventions and during transport to the hospital for acute myocardial
infarction. Cardioprotective signaling has been extensively characterized
in animal experiments. Objective: To identify cardioprotective signaling
by RIPC in humans. Methods and Results: RIPC was induced by 3 cycles of 5
minutes of arm ischemia/5 minutes of reperfusion in patients undergoing
coronary artery bypass surgery. Twelve patients each were randomly
assigned to undergo RIPC or a sham control procedure. Protection was
confirmed by reduced serum troponin I concentrations in patients with RIPC
versus control patients. In myocardial biopsies, an array of established
cardioprotective proteins was analyzed by Western immunoblotting. The
phosphorylation of signal transducer and activator of transcription 5
(STAT5) increased from baseline before ischemic cardioplegic arrest to 10
minutes of reperfusion with RIPC, and STAT5 phosphorylation during
reperfusion was greater in patients with RIPC than in control patients.
Conclusions: The identification of this unique signaling signature of RIPC
will facilitate the development of pharmacological cardioprotection. 2011
American Heart Association, Inc.

<2>
Accession Number
2012022454
Authors
Robinson J.L. Doucette K.
Institution
(Robinson) Department of Pediatrics, University of Alberta, Edmonton,
Canada
(Doucette) Department of Medicine, University of Alberta, Edmonton, Canada
Title
The natural history of hepatitis C virus infection acquired during
childhood.
Source
Liver International. 32 (2) (pp 258-270), 2012. Date of Publication:
February 2012.
Publisher
Blackwell Publishing Ltd (9600 Garsington Road, Oxford OX4 2XG, United
Kingdom)
Abstract
Background: The outcome of patients with hepatitis C virus (HCV) infection
acquired during childhood in the absence of antiviral therapy is not
clear. Aims: The purpose of this study was to review the outcome of
untreated HCV acquired in childhood. Only population-based studies were
included, as referred cases would be predicted to have more severe
disease. Methods: A systematic review of the literature was completed up
to October 2010 to identify studies where a population was screened for
HCV infection that was presumably acquired during childhood. Demographical
and clinical data were collected on infected patients who had not been
treated with an antiviral. Primary outcome was development of a severe
adverse outcome (cirrhosis, hepatoma, need for a liver transplant or
liver-related death). Results: There were 25 studies reporting a total of
733 infected patients. Liver biopsy results were provided for 180 patients
(25%), revealing cirrhosis in eight (1.0% of the total and 4.0% of those
who had a biopsy). None of the other patients developed a severe adverse
outcome. As a result of the small number of patients with a severe adverse
outcome, risk factors for HCV progression could not be identified.
Conclusion: Although HCV can lead to liver transplantation and death
during childhood, the vast majority of patients with disease acquired
during childhood have slowly progressive disease. There is no clear
indication for antiviral therapy in the majority of children with HCV
infection. 2011 John Wiley & Sons A/S.

<3>
Accession Number
2012003354
Authors
Damman P. Clayton T. Wallentin L. Lagerqvist B. Fox K.A.A. Hirsch A.
Windhausen F. Swahn E. Pocock S.J. Tijssen J.G.P. De Winter R.J.
Institution
(Damman, Hirsch, Windhausen, Tijssen, De Winter) Department of Cardiology,
Academic Medical Center, University of Amsterdam, Meibergdreef 9, 1105 AZ
Amsterdam, Netherlands
(Clayton, Pocock) London School of Hygiene and Tropical Medicine, Keppel
Street, London, United Kingdom
(Wallentin, Lagerqvist) Department of Cardiology, Cardiothoracic Center,
University Hospital, Uppsala, Sweden
(Fox) Cardiovascular Research, Department of Medical and Radiological
Sciences, Royal Infirmary, Edinburgh, United Kingdom
(Swahn) Department of Cardiology, Heart Centre, University Hospital,
Linkoping, Sweden
Title
Effects of age on long-term outcomes after a routine invasive or selective
invasive strategy in patients presenting with non-ST segment elevation
acute coronary syndromes: A collaborative analysis of individual data from
the FRISC II - ICTUS - RITA-3 (FIR) trials.
Source
Heart. 98 (3) (pp 207-213), 2012. Date of Publication: February 2012.
Publisher
BMJ Publishing Group (Tavistock Square, London WC1H 9JR, United Kingdom)
Abstract
Objective: To perform a patient-pooled analysis of a routine invasive
versus a selective invasive strategy in elderly patients with non-ST
segment elevation acute coronary syndrome. Methods: A meta-analysis was
performed of patientpooled data from the FRISC IIeICTUSeRITA-3 (FIR)
studies. (Un)adjusted HRs were calculated by Cox regression, with
adjustments for variables associated with age and outcomes. The main
outcome was 5-year cardiovascular death or myocardial infarction (MI)
following routine invasive versus selective invasive management. Results:
Regarding the 5-year composite of cardiovascular death or MI, the routine
invasive strategy was associated with a lower hazard in patients aged
65-74 years (HR 0.72, 95% CI 0.58 to 0.90) and those aged >=75 years (HR
0.71, 95% CI 0.55 to 0.91), but not in those aged <65 years (HR 1.11, 95%
CI 0.90 to 1.38), p=0.001 for interaction between treatment strategy and
age. The interaction was driven by an excess of early MIs in patients <65
years of age; there was no heterogeneity between age groups concerning
cardiovascular death. The benefits were smaller for women than for men
(p=0.009 for interaction). After adjustment for other clinical risk
factors the HRs remained similar. Conclusion: The current analysis of the
FIR dataset shows that the long-term benefit of the routine invasive
strategy over the selective invasive strategy is attenuated in younger
patients aged <65 years and in women by the increased risk of early events
which seem to have no consequences for long-term cardiovascular mortality.
No other clinical risk factors were able to identify patients with
differential responses to a routine invasive strategy. Trial registration:
http://www.controlled-trials.com/ISRCTN82153174 (ICTUS),
http://www.controlled-trials.com/ISRCTN07752711 (RITA-3).

<4>
Accession Number
2012014182
Authors
Shehata N. Burns L.A. Nathan H. Hebert P. Hare G.M.T. Fergusson D. Mazer
C.D.
Institution
(Shehata, Burns, Nathan, Hebert, Hare, Fergusson, Mazer) Departments of
Medicine, Anesthesia and Physiology, University of Toronto, St. Michael's
Hospital, Canada
(Shehata, Burns, Nathan, Hebert, Hare, Fergusson, Mazer) Central Ontario
Region, Canadian Blood Services, Toronto, ON, Canada
(Shehata, Burns, Nathan, Hebert, Hare, Fergusson, Mazer) Department of
Anesthesia, St Michael's Hospital, University of Toronto, Toronto, ON,
Canada
(Shehata, Burns, Nathan, Hebert, Hare, Fergusson, Mazer) Department of
Anesthesia, University of Ottawa, Ottawa, ON, Canada
(Shehata, Burns, Nathan, Hebert, Hare, Fergusson, Mazer) Department of
Critical Care, General Campus, Canada
(Shehata, Burns, Nathan, Hebert, Hare, Fergusson, Mazer) Department of
Clinical Epidemiology, Ottawa Hospital Research Institute, CMAJ, Ottawa,
ON, Canada
Title
A randomized controlled pilot study of adherence to transfusion strategies
in cardiac surgery.
Source
Transfusion. 52 (1) (pp 91-99), 2012. Date of Publication: January 2012.
Publisher
Blackwell Publishing Inc. (350 Main Street, Malden MA 02148, United
States)
Abstract
BACKGROUND: It is important to determine the optimal hemoglobin (Hb)
concentration for red blood cell (RBC) transfusion for patients undergoing
cardiac surgery because increased mortality has been associated with the
severity of anemia and exposure to RBCs. Because a definitive trial will
require thousands of patients, and because there is variability in
transfusion practices, a pilot study was undertaken to determine adherence
to proposed strategies. STUDY DESIGN AND METHODS: A single-center parallel
randomized controlled pilot trial was conducted in high-risk cardiac
patients to assess adherence to two transfusion strategies. Fifty patients
were randomly assigned either to a "restrictive" transfusion strategy
(RBCs if their Hb concentration was 70 g/L or less intraoperatively during
cardiopulmonary bypass [CPB] and 75 g/L or less postoperatively) or a
"liberal" transfusion strategy (RBCs if their Hb concentration was 95 g/L
or less during CPB and less than 100 g/L postoperatively). RESULTS: The
percentage of adherence overall was 84% in the restrictive arm and 41% in
the liberal arm. Twenty-two (88%) patients were transfused 99 units of
RBCs in the liberal group compared to 13 patients who were transfused 50
units in the restrictive group (p < 0.01). There were no significant
differences in individual adverse outcomes; however, more adverse events
occurred in the restrictive group (38 vs. 15, p < 0.01). CONCLUSION:
Adherence to the evaluated interventions is vital to all randomized
controlled trials as it has the potential to affect outcomes. Further
pilot studies are required to optimize enrollment and transfusion
adherence before a definitive study is conducted. 2011 American
Association of Blood Banks.

<5>
Accession Number
22077816
Authors
Tricoci P. Huang Z. Held C. Moliterno D.J. Armstrong P.W. Van de Werf F.
White H.D. Aylward P.E. Wallentin L. Chen E. Lokhnygina Y. Pei J. Leonardi
S. Rorick T.L. Kilian A.M. Jennings L.H. Ambrosio G. Bode C. Cequier A.
Cornel J.H. Diaz R. Erkan A. Huber K. Hudson M.P. Jiang L. Jukema J.W.
Lewis B.S. Lincoff A.M. Montalescot G. Nicolau J.C. Ogawa H. Pfisterer M.
Prieto J.C. Ruzyllo W. Sinnaeve P.R. Storey R.F. Valgimigli M. Whellan
D.J. Widimsky P. Strony J. Harrington R.A. Mahaffey K.W. TRACER
Investigators
Institution
(Tricoci) Duke Clinical Research Institute, Duke University Medical
Center, Durham, NC 27705, USA.
Title
Thrombin-receptor antagonist vorapaxar in acute coronary syndromes.
Source
The New England journal of medicine. 366 (1) (pp 20-33), 2012. Date of
Publication: 5 Jan 2012.
Abstract
Vorapaxar is a new oral protease-activated-receptor 1 (PAR-1) antagonist
that inhibits thrombin-induced platelet activation. In this multinational,
double-blind, randomized trial, we compared vorapaxar with placebo in
12,944 patients who had acute coronary syndromes without ST-segment
elevation. The primary end point was a composite of death from
cardiovascular causes, myocardial infarction, stroke, recurrent ischemia
with rehospitalization, or urgent coronary revascularization. Follow-up in
the trial was terminated early after a safety review. After a median
follow-up of 502 days (interquartile range, 349 to 667), the primary end
point occurred in 1031 of 6473 patients receiving vorapaxar versus 1102 of
6471 patients receiving placebo (Kaplan-Meier 2-year rate, 18.5% vs.
19.9%; hazard ratio, 0.92; 95% confidence interval [CI], 0.85 to 1.01;
P=0.07). A composite of death from cardiovascular causes, myocardial
infarction, or stroke occurred in 822 patients in the vorapaxar group
versus 910 in the placebo group (14.7% and 16.4%, respectively; hazard
ratio, 0.89; 95% CI, 0.81 to 0.98; P=0.02). Rates of moderate and severe
bleeding were 7.2% in the vorapaxar group and 5.2% in the placebo group
(hazard ratio, 1.35; 95% CI, 1.16 to 1.58; P<0.001). Intracranial
hemorrhage rates were 1.1% and 0.2%, respectively (hazard ratio, 3.39; 95%
CI, 1.78 to 6.45; P<0.001). Rates of nonhemorrhagic adverse events were
similar in the two groups. In patients with acute coronary syndromes, the
addition of vorapaxar to standard therapy did not significantly reduce the
primary composite end point but significantly increased the risk of major
bleeding, including intracranial hemorrhage. (Funded by Merck; TRACER
ClinicalTrials.gov number, NCT00527943.).

<6>
Accession Number
2012019313
Authors
Hassan Murad M. Coburn J.A. Coto-Yglesias F. Dzyubak S. Hazem A. Lane M.A.
Prokop L.J. Montori V.M.
Institution
(Hassan Murad, Coburn, Coto-Yglesias, Dzyubak, Hazem, Lane, Prokop,
Montori) Mayo Clinic, Knowledge and Evaluation Research Unit, 200 First
Street SW, Rochester, MN 55905, United States
(Hassan Murad, Hazem) Division of Preventive Medicine, Mayo Clinic,
Rochester, MN 55905, United States
(Hazem) Department of Internal Medicine, University of North Dakota,
Fargo, ND 58103, United States
(Montori) Division of Endocrinology, Diabetes, Metabolism, and Nutrition,
Mayo Clinic, Rochester, MN 55905, United States
Title
Glycemic control in non-critically ill hospitalized patients: A systematic
review and meta-analysis.
Source
Journal of Clinical Endocrinology and Metabolism. 97 (1) (pp 49-58),
2012. Date of Publication: January 2012.
Publisher
Endocrine Society (8401 Connecticut Ave. Suite 900, Chevy Chase MD 20815,
United States)
Abstract
Background: The effect of intensive therapy to achieve tight glycemic
control in patients hospitalized in non-critical care settings is unclear.
Methods:Weconducted a systematic review and meta-analysis to determine the
effect of intensive glycemic control strategies on the outcomes of death,
stroke, myocardial infarction, incidence of infection, and hypoglycemia.
We included randomized and observational studies. Bibliographic databases
were searched through February 2010. Random effects model was used to pool
results across studies. Results: Nineteen studies (nine randomized and 10
observational studies) were included. The risk of bias across studies was
moderate. Meta-analysis demonstrates that intensive glycemic control was
not associated with significant effect on the risk of death, myocardial
infarction, or stroke. There was a trend for increased risk of
hypoglycemia (relative risk, 1.58; 95% confidence interval,0.97-2.57),
particularly in surgical studies and when the planned glycemic target was
achieved. Intensive glycemic control was associated with decreased risk of
infection (relative risk, 0.41; 95% confidence interval, 0.21-0.77) that
was mainly derived from studies in surgical settings. Conclusion:
Intensive control of hyperglycemia in patients hospitalized in
non-critical care settings may reduce the risk of infection. The quality
of evidence is low and mainly driven by studies in surgical settings.
Copyright 2012 by The Endocrine Society.

<7>
Accession Number
2012013932
Authors
Navarese E.P. Kubica J. Castriota F. Gibson C.M. De Luca G. Buffon A.
Bolognese L. Margheri M. Andreotti F. Di Mario C. De Servi S.
Institution
(Navarese, Kubica) Department of Cardiology and Internal Medicine, Ludwik
Rydygier Collegium Medicum, Nicolaus Copernicus University,
Sklodowskiej-Curie Street No 9, 85-094 Bydgoszcz, Poland
(Castriota) GVM Care and Research, Interventional Cardio-Angiology Unit,
Cotignola, Italy
(Gibson) Cardiovascular Division, Beth Israel Deaconess Medical Center,
Harvard Medical School, Boston, MA, United States
(De Luca) Department of Cardiology, Maggiore Della Carita Hospital,
Novara, Italy
(Buffon, Andreotti) Department of Cardiovascular Medicine, Catholic
University of the Sacred Heart, Rome, Italy
(Bolognese) Cardiovascular Department, San Donato Hospital, Arezzo, Italy
(Margheri) Division of Cardiology, Azienda Ospedaliera, Ravenna, Italy
(Di Mario) Royal Brompton Hospital, Imperial College, London, United
Kingdom
(De Servi) Department of Cardiovascular Diseases, Civic Hospital, Legnano,
Italy
Title
Safety and efficacy of biodegradable vs. durable polymer drug-eluting
stents: Evidence from a meta-analysis of randomised trials.
Source
EuroIntervention. 7 (8) (pp 985-994), 2011. Date of Publication:
December 2011.
Publisher
EuroPCR (5 Rue Saint-Pantaleon, Toulouse 31015, France)
Abstract
Aims: Drug-eluting stents (DES) are a major advance in interventional
cardiology; however concerns have been raised regarding their long-term
safety due to the permanent nature of the polymer. New generation stents
with biodegradable polymers (BDS) have recently been developed. The aim of
this study was to perform a meta-analysis of randomised controlled trials
(RCTs) comparing the safety and efficacy profile of BDS vs. durable
polymer DES. Methods and results: The MEDLINE/CENTRAL and Google Scholar
databases were searched for RCTs comparing safety and efficacy of BDS vs.
DES. Safety endpoints were mortality, myocardial infarction (MI), and
stent thrombosis (ST). Efficacy endpoints were target vessel
revascularisation (TVR), target lesion revascularisation (TLR) and
six-month in-stent late loss (ISLL). The meta-analysis included eight RCTs
(n=7,481). At a median follow-up of nine months, as compared to DES, BDS
use did not increase mortality (OR [95% CI] = 0.91 [0.69-1.22], p=0.53) or
MI (OR [95% CI] = 1.14 [0.90-1.44], p=0.29). Rate of late/very late ST was
significantly reduced in BDS patients (OR [95% CI] = 0.60 [0.39-0.91],
p=0.02), as was six-month ISLL (mean difference [95% CI] = -0.07 [-0.12;
-0.02] mm, p=0.004) in comparison with DES patients. Rates of TVR and TLR
were comparable between BDS and DES. Conclusions: BDS are at least as safe
as standard DES with regard to survival and MI, and more effective in
reducing late ST, as well as six-month ISLL. Further large RCTs with
long-term follow-up are warranted to definitively confirm the potential
benefits of BDS. Europa Edition 2011. All rights reserved.

<8>
Accession Number
2012013931
Authors
Sabate M. Cequier A. Iniguez A. Serra A. Hernandez-Antolin R. Mainar V.
Valgimigli M. Tespili M. Den Heijer P. Bethencourt A. Vazquez N.
Brugaletta S. Backx B. Serruys P.W.
Institution
(Sabate, Brugaletta) University Hospital Clinic, Barcelona, Spain
(Cequier) University Hospital of Bellvitge, Barcelona, Spain
(Iniguez) Hospital do Meixoeiro, Vigo, Spain
(Serra) University Hospital of Sant Pau, Barcelona, Spain
(Hernandez-Antolin) University Hospital San Carlos, Madrid, Spain
(Mainar) Hospital General of Alicante, Alicante, Spain
(Valgimigli) University Hospital Ferrara, Ferrara, Italy
(Tespili) University Hospital Bolognini Seriate, Bergamo, Italy
(Den Heijer) Amphia Ziekenhuis, Breda, Netherlands
(Bethencourt) Hospital Son Dureta, Palma de Mallorca, Spain
(Vazquez) Hospital Juan Canalejo, A Coruna, Spain
(Backx) Cardialysis, Rotterdam, Netherlands
(Serruys) Erasmus Medical Center, Rotterdam, Netherlands
Title
Rationale and design of the EXAMINATION trial: A randomised comparison
between everolimus-eluting stents and cobalt-chromium bare-metal stents in
ST-elevation myocardial infarction.
Source
EuroIntervention. 7 (8) (pp 977-984), 2011. Date of Publication:
December 2011.
Publisher
EuroPCR (5 Rue Saint-Pantaleon, Toulouse 31015, France)
Abstract
Aims: To assess the performance of the everolimus-eluting stent (EES)
versus cobalt chromium bare-metal stent (BMS) in the setting of primary
percutaneous coronary intervention for treatment of patients presenting
with ST-segment elevation myocardial infarction (STEMI). The implantation
of a drug-eluting stent in the setting of an acute myocardial infarction
is still controversial. In several registries this clinical scenario has
been associated with the development of stent thrombosis. The EES has
demonstrated to reduce the stent thrombosis rate as compared to
paclitaxel-eluting stent in randomised controlled trials, mainly performed
in patients in stable clinical conditions. There are however few data
regarding the effectiveness of EES in the context of STEMI. Methods and
results: This is an investigator-driven, prospective, multicentre,
multinational, randomised, single blind, two-arm, controlled trial
(ClinicalTrials.gov number: NCT00828087). This trial, with an all comer
design, randomises approximately 1,500 patients 1:1 to EES or BMS.
Overall, any patient presenting with STEMI up to 48 hours who requires
emergent percutaneous coronary intervention can be included. The primary
endpoint is the patient-oriented combined endpoint of all-cause death, any
myocardial infarction and any revascularisation at 1-year according to the
Academic Research Consortium. Clinical follow-up will be scheduled at 30
days, six months, one year and yearly up to five years. No angiographic
follow-up is mandated per protocol. Conclusions: This trial with broad
inclusion and few exclusion criteria will shed light on the performance of
the second generation EES in the complex scenario of STEMI. Europa
Edition 2011. All rights reserved.

<9>
Accession Number
2012013925
Authors
Kang W.C. Ahn T. Lee K. Han S.H. Shin E.K. Jeong M.H. Yoon J.H. Park J.-S.
Bae J.H. Hur S.H. Rha S.W. Oh S.K. Kim D.I. Jang Y. Choi J.W. Kim B.O.
Institution
(Kang, Ahn, Lee, Han, Shin) Cardiology, Gil Hospital, Gachon University of
Medicine and Science, 1198 Kuwol-dong, Namdong-gu, Incheon, South Korea
(Jeong) Chonnam National University Hospital, Gwangju, South Korea
(Yoon) Wonju Christian Hospital, Wonju, South Korea
(Park) Yeungnam University Hospital, Daegu, South Korea
(Bae) Konyang University Hospital, Daejeon, South Korea
(Hur) Keimyung University Dongsan Medical Center, Daegu, South Korea
(Rha) Korea University Guro Hospital, Seoul, South Korea
(Oh) Wonkwang University Hospital, Iksan, South Korea
(Kim) Inje University Busan Paik Hospital, Busan, South Korea
(Jang) Severance Hospital, Seoul, South Korea
(Choi) Eulji Hospital, Seoul, South Korea
(Kim) Inje University Sanggye Paik Hospital, Seoul, South Korea
Title
Comparison of zotarolimus-eluting stents versus sirolimus-eluting stents
versus paclitaxel-eluting stents for primary percutaneous coronary
intervention in patients with ST-elevation myocardial infarction: Results
from the Korean Multicentre Endeavor (KOMER) acute myocardial infarction
(AMI) trial.
Source
EuroIntervention. 7 (8) (pp 936-943), 2011. Date of Publication:
December 2011.
Publisher
EuroPCR (5 Rue Saint-Pantaleon, Toulouse 31015, France)
Abstract
Aims: The aim of this study was to compare the efficacy and safety of
zotarolimus-eluting stents (ZES), sirolimus-eluting stents (SES) and
paclitaxel-eluting stents (PES) in patients with ST-segment elevation
myocardial infarction (STEMI) undergoing primary percutaneous coronary
intervention (PCI).Methods and results: This study was a prospective,
single-blind, multicentre, randomised trial. The primary endpoint was
major adverse cardiac events (MACE) at 12 months post-procedure, defined
as cardiac death, recurrent myocardial infarction (MI), or
ischaemia-driven target lesion revascularisation (TLR). An angiographic
substudy was performed at nine months among 348 patients. From October
2006 to April 2008, 611 patients with STEMI undergoing primary PCI were
randomly assigned to treatment with ZES (n=205), SES (n=204), or PES
(n=202). The cumulative incidence of MACE was 5.9% in the ZES group, 3.4%
in the SES group and 5.7% in the PES group at 12-month follow-up
(p=0.457). There was a trend towards a lower rate of ischaemia-driven TLR
at 12- (p=0.092) and 18-month (p=0.080) follow-up in the SES group
compared to the ZES and PES groups. No difference was observed in rates of
cardiac death, recurrent MI and combined death and/or recurrent MI among
three groups at 12- and 18-month follow-up. The rate of stent thrombosis
was similar among the three groups (2.0% in each group,
p=1.000).Conclusions: As compared with SES and PES, the use of ZES in
patients with STEMI undergoing primary PCI, showed similar rates of MACE,
cardiac death and recurrent MI at 12 and 18 months. There was a trend
towards a higher rate of TLR with ZES or PES compared to SES. Europa
Edition 2011. All rights reserved.

<10>
Accession Number
2012013921
Authors
Genereux P. Mehran R. Palmerini T. Caixeta A. Kirtane A.J. Lansky A.J.
Brodie B.R. Witzenbichler B. Mockel M. Guagliumi G. Peruga J.Z. Dudek D.
Fahy M.P. Dangas G. Stone G.W.
Institution
(Genereux, Mehran, Palmerini, Caixeta, Kirtane, Lansky, Fahy, Dangas,
Stone) Columbia University Medical Center, Cardiovascular Research
Foundation, 111 E. 59th St., New York, NY 10022, United States
(Brodie) LeBauer Cardiovascular Research Foundation, Moses Cone Hospital,
Greensboro, NC, United States
(Witzenbichler, Mockel) Charite-Universitatsmediz in Berlin, Campus
Benjamin Franklin, Campus Virchow-Klinikum, Berlin, Germany
(Guagliumi) Ospedali Riuniti di Bergamo, Bergamo, Italy
(Peruga) Department of Cardiology Medical University, Lodz Bieganski
Hospital, Lodz, Poland
(Dudek) Jagiellonian University, Krakow, Poland
Title
Radial access in patients with ST-segment elevation myocardial infarction
undergoing primary angioplasty in acute myocardial infarction: The
HORIZONS-AMI trial.
Source
EuroIntervention. 7 (8) (pp 905-916), 2011. Date of Publication:
December 2011.
Publisher
EuroPCR (5 Rue Saint-Pantaleon, Toulouse 31015, France)
Abstract
Aims: We sought to determine whether a transradial (TR) approach compared
with a transfemoral (TF) approach was associated with improved clinical
outcomes in patients with ST-segment elevation myocardial infarction
(STEMI) undergoing primary percutaneous coronary intervention (PCI) in a
post hoc analysis of the HORIZONS-AMI trial. There is a paucity of data
comparing the TR approach with the TF approach in patients with STEMI
treated with primary PCI and contemporary anticoagulant regimens. Methods
and results: In HORIZONS-AMI, primary PCI for STEMI was performed in 3,340
patients, either by the TR (n=200) or TF approach (n=3,134). Endpoints
included the 30-day and one-year rates of major adverse cardiovascular
events (MACE: death, reinfarction, stroke or target vessel
revascularisation), non CABG-related major bleeding, and net adverse
clinical events (NACE: MACE or major bleeding). TR compared to TF access
was associated with significantly lower 30-day rates of composite death or
reinfarction (1.0% vs. 4.3%, OR 0.23, 95% CI [0.06,0.94], p=0.02), non
CABG-related major bleeding (3.5% vs. 7.6%, OR 0.45, 95% CI [0.21,0.95],
p=0.03), MACE (2.0% vs. 5.6%, OR 0.35, 95% CI [0.13,0.95], p=0.02), and
NACE (5.0% vs. 11.6%,OR 0.42, 95% CI [0.22,0.78], p<0.01). At one year,
the TR group still had significantly reduced rates of death or
reinfarction (4.0% vs. 7.8%, OR 0.51, 95% CI [0.25,1.02], p=0.05), non
CABG-related major bleeding (3.5% vs. 8.1%, OR 0.42, 95% CI [0.20,0.89],
p=0.02), MACE (6.0% vs. 12.4%, OR 0.47, 95% CI [0.26,0.83], p<0.01) and
NACE (8.5% vs. 17.8%, OR 0.45, 95% CI [0.28,0.74], p<0.001). By
multivariable analysis, TR access was an independent predictor of freedom
from MACE and NACE at 30 days and one year. Conclusions: In patients with
STEMI undergoing primary PCI with contemporary anticoagulation regimens in
the HORIZONS-AMI trial, a TR compared with a TF approach was associated
with reduced major bleeding and improved event-free survival. Europa
Edition 2011. All rights reserved.

<11>
Accession Number
2012022817
Authors
Santangeli P. Di Biase L. Pelargonio G. Dello Russo A. Casella M.
Bartoletti S. David Burkhardt J. Mohanty P. Santarelli P. Natale A.
Institution
(Santangeli, Di Biase, David Burkhardt, Mohanty, Natale) Texas Cardiac
Arrhythmia Institute, St. David's Medical Center, 1015 East 32nd Street,
Austin, TX, United States
(Pelargonio, Santarelli) Institute of Cardiology, Catholic University of
the Sacred Heart, Rome, Italy
(Dello Russo, Casella, Bartoletti) Arrhythmia Department, Institute of
Cardiology, IRCCS-Centro Cardiologico Monzino, Milan, Italy
(Di Biase, Natale) Department of Biomedical Engineering, University of
Texas, Austin, TX, United States
(Di Biase) Department of Cardiology, University of Foggia, Foggia, Italy
Title
Cardiac resynchronization therapy in patients with mild heart failure: A
systematic review and meta-analysis.
Source
Journal of Interventional Cardiac Electrophysiology. 32 (2) (pp 125-135),
2011. Date of Publication: November 2011.
Publisher
Springer Netherlands (Van Godewijckstraat 30, Dordrecht 3311 GZ,
Netherlands)
Abstract
Purpose: Cardiac resynchronization therapy (CRT) reduces symptoms and
improves survival in patients with advanced heart failure (New York Heart
Association (NYHA) functional class III-IV), reduced ejection fraction,
and wide QRS complex. Whether CRT has the same benefit also in
asymptomatic or mildly symptomatic heart failure patients is
controversial. Our objective is to summarize the available evidence on the
effects of CRT in asymptomatic or mildly symptomatic (NYHA I-II) heart
failure patients. Methods: We searched major web databases for randomized
controlled trials of CRT in patients with mild heart failure (NYHA
functional class I-II). Data regarding all-cause mortality, heart failure
events, left ventricular (LV) volumes and ejection fraction, and worsening
of NYHA functional class were extracted. Results: We identified five
trials (CONTAK-CD, MIRACLE ICD-II, REVERSE, MADIT-CRT, and RAFT) that
enrolled 4,213 patients (91% with NYHA II functional class). Primary
analysis excluded the CONTAK-CD, which was not specifically conducted on
patients with mild heart failure. At pooled analysis, CRT decreased
mortality (odds ratio (OR), 0.78 [95% confidence interval (CI)], 0.63 to
0.97; p=0.024) and heart failure events (OR, 0.63 [95% CI, 0.52 to 0.76],
p<0.001), induced a significant LV reverse remodeling (weighted mean
difference (WMD) of LV ejection fraction =+4.8%[95% CI, + 0.9 to+ 8.7%],
p=0.015 and WMD of LV end-systolic volume index =
-19.4mL/m²[95%CI, - 18.2 to - 20.7mL/m²], p<0.001)
and prevented the progression of heart failure symptoms (OR for worsening
of NYHA functional class= 0.54 [95% CI, 0.31 to 0.93], p=0.026). Inclusion
of the CONTAK-CD did not change the results. Conclusions: Among patients
with mild (NYHA II) heart failure, CRT reduces mortality and the risk of
heart failure events, induces a favorable LV reverse remodeling and slows
the progression of heart failure symptoms. Springer Science+Business
Media, LLC 2011.

<12>
Accession Number
70639618
Authors
Haase-Fielitz A. Mertens P.R. Plas M. Kuppe H. Hetzer R. Westerman M.
Ostland V. Prowle J.R. Bellomo R. Haase M.
Institution
(Haase-Fielitz, Mertens, Haase) Otto von Guericke University, Nephrology,
Magdeburg, Germany
(Plas, Kuppe) German Heart Center Berlin, Institute of Anesthesiology,
Berlin, Germany
(Hetzer) German Heart Center Berlin, Department of Cardiothoracic Surgery,
Berlin, Germany
(Westerman, Ostland) Intrinsic LifeSciences LLC, San Diego, United States
(Prowle, Bellomo) Austin Health, Melbourne, Australia
Title
Urine hepcidin is an early predictor of protection from cardiopulmonary
bypass-associated acute kidney injury-an observational cohort study.
Source
Intensive Care Medicine. Conference: 24th Annual Congress of the European
Society of Intensive Care Medicine, ESICM LIVES 2011 Berlin Germany.
Conference Start: 20111001 Conference End: 20111005. Conference
Publication: (var.pagings). 37 (pp S208), 2011. Date of Publication:
September 2011.
Publisher
Springer Verlag
Abstract
INTRODUCTION. Conventional markers of acute kidney injury (AKI) lack
diagnosticaccuracy and are expressed only late after cardiac surgery with
cardiopulmonary bypass(CPB). Recently, interest has focused on hepcidin, a
regulator of iron homeostasis, as a uniquerenal biomarker.OBJECTIVES. We
aimed to (1) assess the predictive value of early postoperative
urinehepcidin and plasma hepcidin for protection from AKI (2) investigate
the role of chronickidney disease on the predictive value of hepcidin and
(3) explore whether changes in urinehepcidin reflect changes in plasma
hepcidin.METHODS. We studied 100 adult patients in the control arm of a
randomized controlled trial(clinicaltrials.gov NCT00672334) that were
identified to be at increased risk of AKI aftercardiac surgery with CPB.
AKI was defined according to the RIFLE classification. Samples ofplasma
and urine were obtained simultaneously (1) before CPB (2) 6 h after the
start of CPBand (3) at 24 h after CPB. Plasma and urine hepcidin
25-isoforms were quantified by competitiveenzyme-linked
immunoassay.RESULTS. At 6 and 24 h after CPB, AKI-free patients (N = 91)
had largely increased andwere 3-7 times higher urine hepcidin
concentrations compared to patients with subsequentAKI (N = 9) in whom
postoperative urine hepcidin remained at preoperative levels(P = 0.004, P
= 0.002). Furthermore, higher urine hepcidin and, even more so, urine
hepcidinadjusted to urine creatinine at 6 h after CPB discriminated
patients who did not developAKI [AUC-ROC 0.80 (95% CI 0.71-0.87); 0.88
(95% CI 0.78-0.97)] or did not need renalreplacement therapy initiation
[AUC 0.81 (95% CI 0.72-0.88); 0.88 (95% CI 0.70-0.99)] fromthose who did.
At 6 h, urine hepcidin adjusted to urine creatinine was an independent
predictorof protection from AKI (P = 0.011). Plasma hepcidin did not
predict protection from AKI.The study findings remained essentially
unchanged after excluding patients with preoperativechronic kidney
disease.CONCLUSIONS. Our findings suggest that urine hepcidin is an early
predictive biomarker ofprotection from AKI after CPB thereby contributing
to early patients risk stratification.

<13>
Accession Number
70639315
Authors
Goepfert M.S. Richter H.P. Kubitz J.C. Von Sandersleben A. Gruetzmacher J.
Rafflenbeul E. Roeher K. Zu Eulenburg C. Reichenspurner H. Goetz A.E.
Reuter D.A.
Institution
(Goepfert, Richter, Kubitz, Von Sandersleben, Gruetzmacher, Rafflenbeul,
Roeher, Goetz, Reuter) University Medical Center Hamburg-Eppendorf,
Anaesthesiolgy and Intensive Care Medicine, Hamburg, Germany
(Zu Eulenburg) University Medical Center Hamburg-Eppendorf, Department of
Medical Biometry and Epidemiology, Hamburg, Germany
(Reichenspurner) University Heart Center Hamburg, Department of
Cardiovascular Surgery, Hamburg, Germany
Title
Does early perioperative goal directed therapy using functional and
volumetric hemodynamic parameters improve therapy in cardiac surgery? A
prospective, Randomized controlled trial.
Source
Intensive Care Medicine. Conference: 24th Annual Congress of the European
Society of Intensive Care Medicine, ESICM LIVES 2011 Berlin Germany.
Conference Start: 20111001 Conference End: 20111005. Conference
Publication: (var.pagings). 37 (pp S132), 2011. Date of Publication:
September 2011.
Publisher
Springer Verlag
Abstract
INTRODUCTION. There is growing evidence that an early and algorithm guided
hemodynamic therapy primarily increasing cardiac output by preload
optimization improves outcome in high risk surgical patients. Preload
optimization was so far guided either by the filling pressures CVP or
PAOP, cardiac output (CO), or functional parameters based on heart lung
interactions, i.e. stroke volume variations (SVV). In particular the
latter one, having shown to be useful intraoperatively under
controlledmechanical ventilation, but becomes invalid in patients under
assisted mechanical ventilation or during spontaneous breathing.
Volumetric parameters of cardiac preload, such as global end-diastolic
volume index (GEDI) differ significantly inter-individually in critically
ill patients, but have been proven to be highly accurate to allow tracking
changes in cardiac preload in both, mechanically ventilated patients, and
during spontaneous breathing. OBJECTIVES. We implemented a hemodynamic
treatment algorithmbased on measurements of CO, SVV, and a
patient-individual GEDI for optimizing therapy during and after elective
cardiac surgery.We compared a study group (SG) guided by this
algorithmwith a control group (CG) guided by an algorithm based on CVP and
mean arterial blood pressure (MAP). METHODS.After approval of the ethic
committee and written informed consent one-hundred patients scheduled for
elective coronary artery bypass (CAB) surgery or CAB surgery in
combination with aortic valve replacement (AVR) were randomized either to
the SG (n = 50), or to the CG (n = 50). Algorithm driven hemodynamic
therapy started immediately after induction of anesthesia and was
commenced until discharge from the intensive care unit (ICU). RESULTS. 92
Patients could finally be analyzed. There was no difference in
perioperative mortality. All over complications were less in the SG (42
vs. 63). Time to reach ICU discharge criteria (SG: 15 +/- 6 h vs. CG: 24
+/- 29 (p<0.001), length of stay on the ICU (SG: 42 +/- 19 h vs.CG: 61 +/-
58 (p<0.05), and time to reach criteria for hospital discharge (SG: 5d +/-
3 vs.CG: 6 +/- 3 (p<0.001) were significantly shorter in the SG. The
cumulative use of catecholamines and vasopressors was significantly less
in the SG (1,196 +/- 1,002 mug) compared to the CG (2,523 +/- 2,205mulg;
p<0.001).Areas under the curve for postoperative (36 h) creatinine kinase,
AST, ALT, and gGT all were smaller in the study group, however without
reaching statistical significance. There were no differences in pulmonary
or renal function within the study period. CONCLUSIONS. Goal-directed
hemodynamic therapy based on an algorithm using measurements of CO, SVV
and a patient-individual GEDI minimizes organ damage and reduces length of
ICU stay after elective cardiac surgery. If long-term outcome can be
improved by these treatment strategies needs to be clarified in the
future.

<14>
Accession Number
70639219
Authors
Paulus F. Veelo D.P. De Nijs S.B. Beenen L.F. Bresser P. De Mol B.A.
Binnekade J.M. Schultz M.J.
Institution
(Paulus, Veelo, Binnekade, Schultz) Academic Medical Center, Department of
Intensive Care, Amsterdam, Netherlands
(De Nijs) Academic Medical Center, Department of Respiratory Medicine,
Amsterdam, Netherlands
(Beenen) Academic Medical Center, Department of Radiology, Amsterdam,
Netherlands
(Bresser) Academic Medical Center, Respiratory Medicine, Amsterdam,
Netherlands
(De Mol) Academic Medical Center, Department of Cardiothoracic Surgery,
Amsterdam, Netherlands
Title
Manual hyperinflation partly prevents reductions of functional residual
capacity in cardiac surgical patients: A randomized controlled trial.
Source
Intensive Care Medicine. Conference: 24th Annual Congress of the European
Society of Intensive Care Medicine, ESICM LIVES 2011 Berlin Germany.
Conference Start: 20111001 Conference End: 20111005. Conference
Publication: (var.pagings). 37 (pp S108), 2011. Date of Publication:
September 2011.
Publisher
Springer Verlag
Abstract
INTRODUCTION. Cardiac surgical patients are kept in an iatrogenic state of
physical and pharmacologic immobilization for several hours after surgery,
to facilitate intubation and weaning from mechanically ventilation.
Immobilization reduces mucociliary transport, which can lead to retention
of sputum at atelectasis. Manual hyperinflation (MH) aims at preventing
airway plugging by mobilization of airway secretions in mechanical
ventilated patients, and as such could improve functional residual
capacity (FRC) and oxygenation after surgery. OBJECTIVES. We performed a
randomized controlled trial in patients after cardiac surgery with the aim
to compare a strategy using routineMHmaneuvers with a strategy only
usingMH if clinically indicated. METHODS. Patients after elective cardiac
surgery and admitted to the ICU of a university hospital were randomly
allocated to "routine" (MH within 1/2 h after arrival in the ICU and every
6 h until tracheal extubation) or "on demand" MH (MH only in case of
failed endotracheal suctioning while sputum is obviously present, or in
case of oxygen de-saturation not responding to 3 min hyper-oxygenation)
during mechanical ventilation. FRC was measured pre-operatively and 1, 3,
and 5 days after extubation. Chest radiographs were obtained, both
pre-operative and on the third post-operative day. Peripheral hemoglobin
saturation (Spo2) was measured at day 1, 3, and 5 after extubation while
the patient was breathing room air. RESULTS. Hundred patients were
enrolled. Patients in the "routine" group received median [IOR] 2
[2-3]MHprocedures compared to 0 [0-0]MHprocedures in the "on demand"
group. In the "routine" group FRC decreased to 72% of the pre-operative
measurement compared to 57% in the "on demand" (P = 0.002). Post-operative
chest radiographs showed more patients without signs of atelectasis in the
routineMHgroup (17%) compared to patients in the control group (0%) (P =
0.002). There were, however, no differences in oxygenation. CONCLUSIONS.
"Routine" MH attenuates reduction of FRC in the early post-operative days
after cardiac surgery. In accordance, occurrence of atelectasis on
post-operative chest radiographs was significant lower in patients who
received MH.

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Total documents retrieved: 16

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<1>
Accession Number
2012011537
Authors
Zangrillo A. Biondi-Zoccai G. Ponschab M. Greco M. Corno L. Covello R.D.
Cabrini L. Bignami E. Melisurgo G. Landoni G.
Institution
(Zangrillo, Greco, Corno, Covello, Cabrini, Bignami, Melisurgo, Landoni)
Department of Anesthesia and Intensive Care, Universita Vita-Salute San
Raffaele, Milan, Italy
(Biondi-Zoccai) Division of Cardiology, University of Modena and Reggio
Emilia, Modena, Italy
(Ponschab) Department of Anaesthesia and Intensive Care, Trauma Hospital
Linz, Linz, Austria
Title
Milrinone and mortality in adult cardiac surgery: A meta-analysis.
Source
Journal of Cardiothoracic and Vascular Anesthesia. 26 (1) (pp 70-77),
2012. Date of Publication: February 2012.
Publisher
W.B. Saunders (Independence Square West, Philadelphia PA 19106-3399,
United States)
Abstract
Objective: The authors conducted a review of randomized studies to show
whether there are any increases or decreases in survival when using
milrinone in patients undergoing cardiac surgery. Design: A meta-analysis.
Setting: Hospitals. Participants: Five hundred eighteen patients from 13
randomized trials. Interventions: None. Measurements and Main Results:
BioMedCentral, PubMed EMBASE, the Cochrane central register of clinical
trials, and conference proceedings were searched for randomized trials
that compared milrinone versus placebo or any other control in the setting
of cardiac surgery that reported data on mortality. Overall analysis
showed that milrinone increased perioperative mortality (13/249 [5.2%] in
the milrinone group v 6/269 [2.2%] in the control arm, odds ratio [OR] =
2.67 [1.05-6.79], p for effect = 0.04, p for heterogeneity = 0.23,
I² = 25% with 518 patients and 13 studies included).
Subanalyses confirmed increased mortality with milrinone (9/84 deaths
[10.7%] v 3/105 deaths [2.9%] with other drugs as control, OR = 4.19
[1.27-13.84], p = 0.02) with 189 patients and 5 studies included) but did
not confirm a difference in mortality (4/165 [2.4%] in the milrinone group
v 3/164 [1.8%] with placebo or nothing as control, OR = 1.27 [0.28-5.84],
p = 0.76 with 329 patients and 8 studies included). Conclusions: This
analysis suggests that milrinone might increase mortality in adult
patients undergoing cardiac surgery. The effect was seen only in patients
having an active inotropic drug for comparison and not in the placebo
subgroup. Therefore, the question remains whether milrinone increased
mortality or if the control inotropic drugs were more protective. 2012
Elsevier Inc. All rights reserved.

<2>
Accession Number
2012011543
Authors
Kumar A.B. Suneja M. Bayman E.O. Weide G.D. Tarasi M.
Institution
(Kumar, Bayman, Weide, Tarasi) Department of Anesthesia, University of
Iowa Hospitals and Clinics, 200 Hawkins Drive, Iowa City, IA 52242, United
States
(Suneja) Department of Nephrology, University of Iowa Hospitals and
Clinics, Iowa City, IA, United States
(Bayman) Department of Biostatistics, College of Public Health, Iowa City,
IA, United States
Title
Association between postoperative acute kidney injury and duration of
cardiopulmonary bypass: A meta-analysis.
Source
Journal of Cardiothoracic and Vascular Anesthesia. 26 (1) (pp 64-69),
2012. Date of Publication: February 2012.
Publisher
W.B. Saunders (Independence Square West, Philadelphia PA 19106-3399,
United States)
Abstract
Objective: This meta-analysis examined the association between
cardiopulmonary bypass (CPB) time and acute kidney injury (AKI). Design:
Meta-analysis of previously published studies. Setting: Each single-center
study was conducted in a surgical intensive care unit and/or academic or
university hospital. Participants: Adult patients undergoing heart surgery
with CPB. Interventions: A systematic literature review was conducted
using PubMed, EMBASE, and Cochrane Library databases and Google Scholar
from January 1980 through September 2009. Initial search results were
refined to include human subjects, age >18 years, randomized controlled
trials, and prospective and retrospective cohort studies, meet the Acute
Kidney Injury Network definition of renal failure, and report times on
CPB. Measurements and main results: The length of time on CPB has been
implicated as an independent risk factor for development of AKI after CPB
(AKI-CPB). The 9 independent studies included in the final meta-analysis
had 12,466 patients who underwent CPB. Out of these, 756 patients (6.06%)
developed AKI-CPB. In 7 of the 9 studies, the mean CPB times were
statistically longer in the AKI-CPB cohort compared with the control group
(cohort without AKI). The absolute mean differences in CPB time between
the 2 groups were 25.65 minutes with the fixed-effects model and 23.18
minutes with the random-effects model. Conclusions: Longer CPB times are
associated with a higher risk of developing AKI-CPB, which, in turn, has a
significant effect on overall mortality as reported by the individual
studies. 2012 Elsevier Inc. All rights reserved.

<3>
Accession Number
2012011542
Authors
Kumbharathi R.B. Taneja R. Mehra R. Quantz M.A. Guo L.R. Bainbridge D.T.
Institution
(Kumbharathi) Department of Anesthesia, Thompson General Hospital,
Burntwood Regional Health Authority, Thompson, MB, Canada
(Taneja, Bainbridge) Department of Anesthesia and Peri-Operative Medicine,
London Health Sciences Centre, University of Western Ontario, London, ON,
Canada
(Mehra) Department of Anesthesia and Perioperative Medicine, Alfred
Hospital, Melbourne, VIC, Australia
(Quantz, Guo) Department of Cardiovascular and Thoracic Surgery, London
Health Sciences Centre, University of Western Ontario, London, ON, Canada
Title
Evaluation of tricuspid and pulmonary valves using epicardial and
transesophageal echocardiography - A comparative study.
Source
Journal of Cardiothoracic and Vascular Anesthesia. 26 (1) (pp 32-38),
2012. Date of Publication: February 2012.
Publisher
W.B. Saunders (Independence Square West, Philadelphia PA 19106-3399,
United States)
Abstract
Objective: To compare measurements obtained by transesophageal
echocardiography (TEE) and epicardial echocardiography (EE) for evaluation
of the tricuspid valve (TV) and pulmonary valve (PV). Design: Prospective
observational. Setting: University hospital. Participants: Patients
undergoing elective coronary artery bypass grafting with or without aortic
valve replacement. Interventions: After routine intraoperative TEE, EE was
performed to compare measurements obtained by the 2 methods. Measurements
and main results: After institutional review board approval, 25 patients
>18 years old were recruited. Biases with EE versus TEE for E and A waves
were 11.9 cm/second (95% confidence interval [CI], 48.2 to -24.4) and 6.8
cm/second (95% CI, 28 to -15), respectively, and for E/A ratio was 0.08
(95% CI, 1.2 to -1). Pulmonary velocity bias was 57.94 cm/second (95% CI,
192.9 to -76.98), with higher values using EE. Bias for pulmonary trunk
diameter was -0.31 cm (95% CI, 1.5 to -2.1). For quality of images, means
were 2.4 (standard deviation [SD], 1.0) for EE and 2.3 (SD, 0.57) with TEE
for TV and 2.4 (SD, 1.0) with EE and 2.5 (SD, 1.0) with TEE for PV. For
the number of leaflets visualized, means were 2.2 (SD, 1.0) with EE and
2.5 (SD, 0.5) with TEE for TV and 2.5 (SD, 0.5) for EE and 1.3 (SD, 1.1)
with TEE for PV. Conclusions: There was good agreement for Doppler
measurements across TVs; however, measurements across PVs were
significantly higher with EE versus TEE. TV Doppler measurements were
difficult to acquire even for surgeons experienced in epiaortic scanning.
2012 Elsevier Inc. All rights reserved.

<4>
Accession Number
2012011532
Authors
Greco M. Landoni G. Biondi-Zoccai G. Cabrini L. Ruggeri L. Pasculli N.
Giacchi V. Sayeg J. Greco T. Zangrillo A.
Institution
(Greco, Landoni, Cabrini, Ruggeri, Pasculli, Giacchi, Sayeg, Greco,
Zangrillo) Department of Anesthesiology and Intensive Care, Vita-Salute
San Raffaele University, Milan, Italy
(Biondi-Zoccai) Interventional Cardiology, Division of Cardiology,
University of Turin, Turin, Italy
Title
Remifentanil in cardiac surgery: A meta-analysis of randomized controlled
trials.
Source
Journal of Cardiothoracic and Vascular Anesthesia. 26 (1) (pp 110-116),
2012. Date of Publication: February 2012.
Publisher
W.B. Saunders (Independence Square West, Philadelphia PA 19106-3399,
United States)
Abstract
Objective: The authors conducted a review of randomized controlled trials
to identify advantages in clinically relevant outcomes in patients
undergoing cardiac surgery with remifentanil. Design: Meta-analysis.
Setting: Hospitals. Participants: A total of 1,473 patients from 16
randomized trials. Interventions: None. Measurements and Main Result:
PubMed, BioMedCentral, and conference proceedings were searched (updated
May 2010) for randomized trials that compared remifentanil with fentanyl
or sufentanil in cardiac anesthesia. Four independent reviewers performed
data extraction, with divergences resolved by consensus. Overall analysis
showed that the use of remifentanil was associated with a significant
reduction in postoperative mechanical ventilation (WMD = -139 min [-244,
-32], p for effect = 0.01, p for heterogeneity < 0.001, I₂ =
89%); length of hospital stay (WMD = -1.08 days [-1.60, -0.57], p for
effect < 0.0001, p for heterogeneity = 0.004, I₂ = 71%); and
cardiac troponin-I release (WMD = -2.08 ng/mL [-3.93, -0.24], p for effect
= 0.03, p for heterogeneity < 0.02, I₂ = 74%). No difference
was noted in mortality (3/344 [0.87%] in the remifentanil group vs [1.06%]
the control group, OR 0.76 [0.17-3.38], p for effect = 0.72, p for
heterogeneity = 0.35, I₂ = 5%). Conclusions: Remifentanil
reduces cardiac troponin release, time of mechanical ventilation, and
length of hospital stay in patients undergoing cardiac surgery.

<5>
Accession Number
2011707318
Authors
Ahn S.W. Shim J.K. Youn Y.N. Song J.W. Yang S.Y. Chung S.C. Kwak Y.L.
Institution
(Ahn) Department of Anesthesiology and Pain Medicine, Kwandong University
College of Medicine, Goyang, South Korea
(Shim, Youn, Song, Yang, Chung, Kwak) Department of Anesthesiology and
Pain Medicine, Seoul, South Korea
(Shim, Kwak) Anesthesia and Pain Research Institute, Seoul, South Korea
(Youn) Department of Cardiothoracic Surgery, Seoul, South Korea
(Kwak) Severance Biomedical Science Institute, Yonsei University College
of Medicine, Seoul, South Korea
Title
Effect of tranexamic acid on transfusion requirement in dual
antiplatelet-treated anemic patients undergoing off-pump coronary artery
bypass graft surgery-a randomized controlled study.
Source
Circulation Journal. 76 (1) (pp 96-101), 2012. Date of Publication:
January 2012.
Publisher
Japanese Circulation Society (14 Yoshida Kawaharacho, Sakyo-ku, Kyoto 606,
Japan)
Abstract
Background: Anemia is not rare in patients presenting for coronary artery
bypass graft surgery (CABG) and as these patients are frequently on dual
antiplatelet therapy (DAPT), the coexisting conditions could potentially
increase the risk of bleeding and transfusion. The aim of this study was
to evaluate the effect of tranexamic acid (TA) on blood loss and
transfusion in preoperatively anemic patients who continued DAPT until
within 5 days of off-pump CABG (OPCAB). Methods and Results: Seventy-six
anemic patients were randomized into 2 groups: TA group receiving TA (1 g
bolus followed by infusion at 200 mg/h) and a Control group receiving the
same volume of saline. The amount of blood loss and transfusion
requirement during, and at 4 and 24 h after the operation were assessed.
Patients' characteristics and operative data were similar between the
groups. During the perioperative period, which combined the intraoperative
and postoperative 24 h data, the TA group received significantly smaller
amounts of packed red blood cells and fresh frozen plasma. Total amount of
perioperative blood loss was similar between the groups, although the
blood loss during the postoperative 4 h was significantly less in the TA
group. Conclusions: TA infusion could reduce the amount of transfusion
during the perioperative period in patients with preoperative anemia who
continue DAPT until within 5 days of OPCAB.

<6>
Accession Number
2011662786
Authors
Lip G.Y.H. Andreotti F. Fauchier L. Huber K. Hylek E. Knight E. Lane D.
Levi M. Marin F. Palareti G. Kirchhof P.
Institution
(Lip, Lane, Kirchhof) University of Birmingham Centre for Cardiovascular
Sciences, City Hospital, Birmingham B18 7QH, United Kingdom
(Andreotti) Department of Cardiovascular Medicine, A. Gemelli University
Hospital, Rome, Italy
(Fauchier) Cardiologie B, Centre Hospitalier Universitaire Trousseau et
Universite Francois Rabelais, Tours, France
(Huber) 3rd Dept of Medicine, Cardiology and Emergency Medicine,
Wilhelminenhospital, Vienna, Austria
(Hylek) Department of Medicine, Research Unit-Section of General Internal
Medicine, Boston University Medical Center, Boston, MA, United States
(Knight) Patient Representative, AntiCoagulation Europe, Bromley, United
Kingdom
(Levi) Department of Medicine, Academic Medical Center, University of
Amsterdam, Amsterdam, Netherlands
(Marin) Department of Cardiology, Hospital Universitario Virgen de la
Arrixaca, Murcia, Spain
(Palareti) Department of Angiology and Blood Coagulation, University
Hospital S. Orsola-Malpighi, Bologna, Italy
(Kirchhof) Department of Cardiology and Angiology, Universitatsklinikum
Munster, Munster, Germany
Title
Bleeding risk assessment and management in atrial fibrillation patients:
Executive summary# of a position document from the european heart rhythm
association [EHRA], endorsed by the european society of cardiology [ESC]
working group on thrombosis.
Source
Thrombosis and Haemostasis. 106 (6) (pp 997-1011), 2011. Date of
Publication: 2011.
Publisher
Schattauer GmbH (Hoelderlinstr 3 Stuttgart D-70174, Germany)
Abstract
In this executive summary of a Consensus Document from the European Heart
Rhythm Association, endorsed by the European Society of Cardiology Working
Group on Thrombosis, we comprehensively review the published evidence and
propose a consensus on bleeding risk assessments in atrial fibrillation
(AF) patients. The main aim of the document was to summarise 'best
practice' in dealing with bleeding risk in AF patients when approaching
antithrombotic therapy, by addressing the epidemiology and size of the
problem, and review established bleeding risk factors. We also summarise
definitions of bleeding in the published literature. Patient values and
preferences balancing the risk of bleeding against thromboembolism as well
as the prognostic implications of bleeding are reviewed. We also provide
an overview of published bleeding risk stratification and bleeding risk
schema. Brief discussion of special situations (e.g. periablation,
peri-devices such as implantable cardioverter defibrillators [ICD] or
pacemakers, presentation with acute coronary syndromes and/or requiring
percutanous coronary interventions/stents and bridging therapy) is made,
as well as a discussion of the prevention of bleeds and managing bleeding
complications. Finally, this document puts forwards consensus statements
that may help to define evidence gaps and assist in everyday clinical
practice. Schattauer 2011.

<7>
Accession Number
21645199
Authors
Krohm P. Levionnois O. Ganster M. Zilberstein L. Spadavecchia C.
Institution
(Krohm, Levionnois, Spadavecchia) Anaesthesia Section, Department for
Clinical Veterinary Medicine, Vetsuisse Faculty, University of Bern,
Switzerland
(Ganster, Zilberstein) Allevia AG, The Bone CRO, Bern, Switzerland
Title
Antinociceptive activity of pre- versus post-operative intra-articular
bupivacaine in goats undergoing stifle arthrotomy.
Source
Veterinary Anaesthesia and Analgesia. 38 (4) (pp 363-373), 2011. Date of
Publication: July 2011.
Publisher
Blackwell Publishing Ltd (9600 Garsington Road, Oxford OX4 2XG, United
Kingdom)
Abstract
Objective To evaluate the peri-operative analgesic efficacy of
intra-articular bupivacaine administered before or after stifle
arthrotomy. Study design Prospective, randomized, blind,
placebo-controlled experimental trial. Animals Thirty-nine healthy goats.
Methods The goats were allocated randomly to one of three intra-articular
treatment groups: group PRE (bupivacaine before and saline after surgery),
group POST (saline before and bupivacaine after surgery) and group CON
(saline before and after surgery). Anaesthesia was maintained with a
constant end-tidal sevoflurane of 2.5%. Intra-operatively heart rate (HR),
respiratory rate and mean arterial blood pressure (MAP) after critical
surgical events (CSE) were recorded and compared with pre-incision values.
Propofol requirements to maintain surgical anaesthesia were recorded.
Flunixin was administered for 5days. Post-operative pain assessment at
20minutes, 2hours, 4hours after recovery and on day 2 and 3 included a
multidimensional pain score (MPS), a lameness score and mechanical
nociceptive threshold (MNT) testing. Rescue analgesia consisted of
systemic opioids. Data were analysed using Kruskal-Wallis, Mann-Whitney,
Friedman or chi-square tests as appropriate. Results Intra-operatively,
group PRE had lower HR and MAP at several CSEs than groups POST/CON and
required less propofol [0mgkg^-1 (0-0mgkg^-1)] than
group POST/CON [0.3mgkg^-1 (0-0.6mgkg^-1)].
Post-operatively, group POST had significantly higher peri-articular MNTs
than groups PRE and CON up to 4hours after recovery. No treatment effect
was detected for MPS, lameness scores and rescue analgesic consumption at
any time point. Conclusions and clinical relevance Pre-operative
intra-articular bupivacaine provided notable intra-operative analgesia in
goats undergoing stifle arthrotomy but did not reduce post-operative pain.
Post-operative intra-articular bupivacaine provided a short lasting
reduction of peri-articular hyperalgesia without affecting the
requirements for systemic analgesia. Multimodal perioperative pain therapy
is recommended to provide adequate analgesia for stifle arthrotomy in
goats. 2011 The Authors. Veterinary Anaesthesia and Analgesia. 2011
Association of Veterinary Anaesthetists and the American College of
Veterinary Anesthesiologists.

<8>
Accession Number
2012002986
Authors
Lawson E.H. Gibbons M.M. Ingraham A.M. Shekelle P.G. Ko C.Y.
Institution
(Lawson, Gibbons, Ingraham, Ko) Department of Surgery, David Geffen School
of Medicine, University of California, Los Angeles, CA 90095, United
States
(Lawson, Ingraham, Ko) Division of Research and Optimal Patient Care,
American College of Surgeons, Chicago, IL, United States
(Gibbons) Department of Surgery, Olive View-UCLA (University of
California, Los Angeles) Medical Center, Sylmar, CA, United States
(Ingraham) Department of Surgery, University of Cincinnati, College of
Medicine, Cincinnati, OH, United States
(Shekelle) RAND Health, Santa Monica, CA, United States
(Shekelle, Ko) VA Greater Los Angeles Healthcare System, Los Angeles, CA,
United States
Title
Appropriateness criteria to assess variations in surgical procedure use in
the United States.
Source
Archives of Surgery. 146 (12) (pp 1433-1440), 2011. Date of Publication:
December 2011.
Publisher
American Medical Association (515 North State Street, Chicago IL 60654,
United States)
Abstract
Objectives: To systematically describe appropriateness criteria (AC)
developed in the United States for surgical procedures and to summarize
how these criteria have been applied to identify overuse and underuse of
procedures in US populations. Data Sources: MEDLINE literature search
performed in February 2010 and May 2011. Study Selection: Studies were
included if they addressed the appropriateness of a surgical procedure
using the RAND-UCLA Appropriateness Method. Non-US studies were excluded.
Data Extraction: Information was abstracted on study design, surgical
procedure, and reported rates of appropriate use, overuse, and underuse.
Identified AC were cross-referenced with lists of common procedures from
the Nationwide Inpatient Sample and the State Ambulatory Surgery
databases. Data Synthesis: A total of 1601 titles were identified; 39 met
the inclusion criteria. Of these, 17 developed AC and 27 applied AC to US
populations. Appropriateness criteria have been developed for 16 surgical
procedures. Underuse has only been studied for coronary artery bypass
graft surgery, and rates range from 24% to 57%. Overuse has been more
broadly studied, with rates ranging from 9% to 53% for carotid
endarterectomy, 0% to 14% for coronary artery bypass graft, 11% to 24% for
upper gastrointestinal tract endoscopy, and 16% to 70% for hysterectomy.
Appropriateness criteria exist for 10 of the 25 most common inpatient
procedures and 6 of the 15 top ambulatory procedures in the United States.
Most studies are more than 5 years old. Conclusions: Most existing AC are
outdated, and AC have never been developed for most common surgical
procedures. A broad and coordinated effort to develop and maintain AC
would be required to implement this tool to address variation in the use
of surgical procedures. 2011 American Medical Association. All rights
reserved.

<9>
Accession Number
2011710920
Authors
Plewka M. Krzeminska-Pakula M. Peruga J.Z. Lipiec P. Kurpesa M.
Wierzbowska-Drabik K. Korycka-Wolowiec A. Kasprzak J.D.
Institution
(Plewka, Krzeminska-Pakula, Peruga, Kurpesa, Wierzbowska-Drabik, Kasprzak)
Department of Cardiology, Medical University of Lodz, ul. Kniaziewicza
1/5, 91-347 Lodz, Poland
(Lipiec) Department of Rapid Cardiac Diagnostics, Medical University of
Lodz, Lodz, Poland
(Korycka-Wolowiec) Department of Haematology, Medical University of Lodz,
Lodz, Poland
Title
The effects of intracoronary delivery of mononuclear bone marrow cells in
patients with myocardial infarction: A two year follow-up results.
Source
Kardiologia Polska. 69 (12) (pp 1234-1240), 2011. Date of Publication:
2011.
Publisher
Klinika Kardiologii CMKP (ul. Grenadierow 51/59, Warsaw 04-073, Poland)
Abstract
Background: Transplantation of bone marrow stem cells (BMSC) is a new
method of prevention of left ventricular (LV) remodelling in
post-infarction patients. Studies published to date point to LV systolic
and diastolic function improvement following this therapy however only a
few studies assessed the long-term effects of BMSC. Aim: To assess the 2
year prognosis in patients with anterior myocardial infarction (MI)
treated with BMSC transplantation in the acute phase. Methods: The study
group consisted of 60 patients with first anterior ST-segment elevation MI
(STEMI), treated with primary percutaneous angioplasty, with baseline LV
ejection fraction (LVEF) < 40%, who were randomly assigned to undergo BMSC
transplantation on day 7 of the STEMI (40 patients, BMSC group) or to
receive standard treatment (20 patients, control group). In all the
patients echocardiography was performed at baseline and after 1, 3, 6, 12
and 24 months. The composite end-point (death, MI, admission for heart
failure or repeat revascularisation) was assessed after 2 years of
follow-up. Results: Absolute increase of LVEF compared to baseline values
was higher in the BMSC group than in the control group. The LVEF increase
in BMSC group at 1 month was 7.1% (95% CI 3.1-11.1%), at 6 months - 9.3%
(95% CI 5.3-13.3%), at 12 months - 11.0% (95% CI 6.2-13.3%) and at 24
months - 10% (95% CI 7.2-12.1%). In the control group, LVEF increase was
3.7% (95% CI 2.3-9.7%) at 1 month, 4.7% (95% CI 1.2-10.6%) at 6 months,
4.8% (95% CI 1.5-11.0%) at 12 months and 4.7% (95% CI 1.4-10.7%) at 24
months. The composite end-point occurred significantly more frequently in
the control group (55%) than in the BMSC group (23%): OR 2.72; 95% CI
1.06-7.02, p = 0.015. Conclusions: Treatment with mononuclear bone marrow
cells on day 7 of the first anterior MI in patients with significant
baseline systolic dysfunction improves 2-year outcome. Copyright Polskie
Towarzystwo Kardiologiczne.

<10>
Accession Number
2011696332
Authors
Mathur P.N.
Institution
(Mathur) Indiana University School of Medicine, Indianapolis, IN, United
States
Title
Intrapleural t-PA plus DNase improved clinical outcomes in patients with
pleural infection.
Source
Annals of Internal Medicine. 155 (12) (pp JC6-9), 2011. Date of
Publication: 20111220.
Publisher
American College of Physicians (190 N. Indenpence Mall West, Philadelphia
PA 19106-1572, United States)

<11>
Accession Number
21526669
Authors
Aghdaii N. Azarfarin R. Yazdanian F. Faritus S.Z.
Institution
(Aghdaii) Department of Anesthesiology, Shahid Rajaii cardiovascular
Medical Center, Iran University of Medical Sciences, Tehran, Iran, Islamic
Republic of
(Azarfarin, Yazdanian, Faritus) Cardiovascular Research Center, Madani
Heart hospital, Tabriz University of Medical Sciences, Tabriz, Iran,
Islamic Republic of
Title
Cardiovascular responses to orotracheal intubation in patients undergoing
coronary artery bypass grafting surgery: Comparing fiberoptic bronchoscopy
with direct laryngoscopy.
Source
Middle East Journal of Anesthesiology. 20 (6) (pp 833-838), 2010. Date
of Publication: October 2010.
Publisher
American University of Beirut (P.O.Box 11-0236, Beirut 1107 2020, Lebanon)
Abstract
Background: The intubation by using fiberoptic brochoscop (FOB) can avoid
the mechanical stimulus to oropharyngolaryngeal structures thereby it is
likely to attenuate hemodynamic response during orotracheal intubation.
Based on this hypothesis, we compared the hemodynamic responses to
orotracheal intubation using an FOB and direct laryngoscope (DLS) in
patients undergoing general anesthesia for coronary artery bypass grafting
(CABG) surgery. Methods: Fifty patients with ASA physical status II and
Mallampati score I and II were scheduled for elective CABG surgery under
general anesthesia requiring orotracheal intubation were randomly
allocated to either DLS group (n = 25) or FOB group (n = 25). The same
protocol of anesthetic medications was used. Invasive systolic and
diastolic blood pressure (SBP & DBP) and heart rate (HR) were recorded
before and after anesthesia induction, during intubation and in the first
and second minutes after intubation. The differences among the hemodynamic
variables recorded over time and differences in the circulatory variables
between the two study groups were compared. Results: Duration of
intubation was shorter in DLS group (19.3 +/- 4.7 sec) compared with FOB
group (34.9 +/- 9.8 sec; p = 0.0001). In both study groups basic SBP and
DBP and HR were not significantly different (P >0.05). During the
observation, there were no significant differences between the two groups
in BP or HR at any time points or in their maximal values (all p values
>0.05). Conclusion: We conclude that the FOB had no advantage in
attenuating the hemodynamic responses to orotracheal intubation in
patients undergoing CABG surgery.

<12>
Accession Number
20557390
Authors
Utriyaprasit K. Moore S.M. Chaiseri P.
Institution
(Utriyaprasit) Mahidol University, Bankoknoi, Bangkok, Thailand
(Moore) School of Nursing, Case Western Reserve University, Cleveland, OH,
United States
(Chaiseri) Central Chest Institute Muang, Nonthaburi, Thailand
Title
Recovery after coronary artery bypass surgery: Effect of an audiotape
information programme.
Source
Journal of Advanced Nursing. 66 (8) (pp 1747-1759), 2010. Date of
Publication: August 2010.
Publisher
Blackwell Publishing Ltd (9600 Garsington Road, Oxford OX4 2XG, United
Kingdom)
Abstract
Aim.: The aim of the study was to test the effect of an audiotape giving
concrete objective information and strategies to reduce symptoms,
psychological distress and enhance physical functioning in patients having
coronary artery bypass grafts. Background.: The period following hospital
discharge is stressful for patients having coronary artery bypass grafts.
Evident-based interventions are needed to improve outcomes in Thai
populations following coronary artery bypass graft surgery. Methods.: A
randomized controlled trial was conducted during 2004-2005. A sample of
120 Thai patients having coronary artery bypass grafts was randomly
assigned to an intervention group or a control group. The intervention
group was given an information audiotape the day prior to hospital
discharge, and encouraged to listen to it as many times as necessary.
Participants were interviewed using validated instruments predischarge and
at 2 weeks and 4 weeks after discharge. Findings.: Participants in the
intervention group had statistically significantly fewer symptoms of
shoulder, back or neck pain and lack of appetite, and increased physical
activity after discharge, compared to the control group. This effect
remained statistically significant after controlling for age, gender,
co-morbidity and presurgical cardiac functional status. However, no
statistically significant difference in psychological distress was
observed. Conclusion.: Nurses can use an audiotape containing preparatory
information to improve outcomes for patients having coronary artery bypass
grafts during the few weeks after discharge from hospital. Further studies
are recommended to improve its effect on psychological distress. 2010
Blackwell Publishing Ltd.

<13>
Accession Number
70628103
Authors
Preiss D. Seshasai S.R.K. Welsh P. Sattar N. Ray K.
Institution
(Preiss, Seshasai, Welsh, Sattar, Ray) GlasgowUnited Kingdom
(Preiss, Seshasai, Welsh, Sattar, Ray) CambridgeUnited Kingdom
(Preiss, Seshasai, Welsh, Sattar, Ray) LondonUnited Kingdom
Title
Risk of incident diabetes on intensive compared to moderate dose statin
therapy: A collaborative meta-analysis of randomized trials.
Source
Diabetes. Conference: 71st Scientific Sessions of the American Diabetes
Association San Diego, CA United States. Conference Start: 20110624
Conference End: 20110628. Conference Publication: (var.pagings). 60 (pp
A88), 2011. Date of Publication: July 2011.
Publisher
American Diabetes Association Inc.
Abstract
A recent meta-analysis demonstrated that statin therapy is associated with
an excess risk of developing diabetes. Whether any such relationship
exists between intensive statin therapy and new-onset diabetes compared to
moderate dose therapy is unclear. We searched Medline, Embase and the
Cochrane Central Register of Controlled Trials from 1996 to 2010 for
randomized controlled endpoint trials including more than 1000 patients
with identical follow-up in both arms and duration of more than 1 year.
Using published and unpublished data, we calculated trial-specific risk
estimates for patients developing diabetes and experiencing major
cardiovascular events (cardiovascular death, nonfatal myocardial
infarction or stroke, coronary revascularization), and combined these
using random-effects model meta-analysis. Between-study heterogeneity was
assessed using the I ² statistic. We identified five statin
trials with 32,752 participants without diabetes, of whom 2,749 (1,449
assigned intensive therapy, 1,300 assigned standard therapy) developed
diabetes and 6,684 (3,134 and 3,550 respectively) experienced
cardiovascular events over an average follow-up of 4.9 years. Intensive
statin therapy was associated with a 12% higher risk for newonset diabetes
(odds ratio [OR] 1.12; 95% CI 1.04-1.22; I ²=0%) and 16%
reduction in cardiovascular events (OR 0.84; 95% CI 0.75-0.94; I
²=74%). For every three fewer patients experiencing major
cardiovascular events on intensive therapy, one additional case of
diabetes occurred. (Table presented).

<14>
Accession Number
70627056
Authors
Pike K. Brierley R. Rogers C.A. Murphy G.J. Reeves B.C.
Institution
(Pike, Brierley, Rogers, Murphy, Reeves) Bristol Heart Institute,
University of Bristol, Bristol BS2 8HW, United Kingdom
Title
Adherence in a randomised controlled trial comparing liberal and
restrictive red blood cell (RBC) transfusion protocols after cardiac
surgery (TITRe2).
Source
Trials. Conference: Clinical Trials Methodology Conference 2011 Bristol
United Kingdom. Conference Start: 20111004 Conference End: 20111005.
Conference Publication: (var.pagings). 12 , 2011. Date of Publication:
13 Dec 2011.
Publisher
BioMed Central Ltd.
Abstract
Objectives: The TITRe2 trial is comparing two haemoglobin (Hb) thresholds
for RBC transfusion after cardiac surgery, Hb<9.0g/dl (liberal) vs.
Hb<7.5g/dl (restrictive). Based on historic data, and with complete
adherence, transfusion rates should be 100% in the liberal and 30% in the
restrictive group. Convergence of these rates due to non-adherence
severely threatens the power of the trial; there is also concern about
differential nonadherence, with transfusion being delayed or withheld in
the liberal group when Hb remains close to the 9.0g/dl threshold. Methods:
In order to capture non-adherence, research staff collect data describing:
The lowest daily Hb; Date and time of each RBC transfusion and the
preceding Hb measurement; Number of breaches of the allocated threshold
before a transfusion is prescribed. These data allow non-adherence to the
randomisation and transfusion protocols to be detected: Failure to
randomise when the 9.0g/dl threshold is breached; Randomised >24 hours
after first breaching Hb 9.0g/dl threshold; Randomised without or before
breaching Hb 9.0g/dl threshold; After randomisation, transfusion given
when allocated threshold not breached ('extra'), or transfusion withheld
when allocated threshold breached ('withheld'); Instances of extra and
withheld transfusions are classified as mild, moderate or severe depending
on their likely influence on overall transfusion rates. Results: 56% of
participants are being randomised; about 8% of the remaining 44% consented
participants breach the 9.0g/dl threshold but are not randomised. 3% of
randomised participants are randomised >24 hours after first breaching,
but none has been randomised without or before breaching the 9.0g/dl
threshold. 32% of participants have had >=1 instance of non-adherence to
the transfusion protocol; in 6%, non-adherence was judged severe (extra -
transfused and patient did not breach at any point post-randomisation;
withheld - not transfused and patient had no postrandomisation
transfusions). Site-specific rates of non-adherence are being fedback to
try to improve adherence. Rates of transfusion in the liberal and
restrictive groups are confidential to the Data Monitoring and Ethics
Committee (DMEC). Conclusions: We believe that this is the first attempt
to measure withheld transfusions in trials of this kind. Data collection
to do this is burdensome but satisfactory. The current rates of
transfusion in the liberal and restrictive groups are, so far, judged by
the DMEC to be consistent with the sample size justification.

<15>
Accession Number
70626993
Authors
Rogers C.A. Pike K. Angelini G.D. Reeves B.C.
Institution
(Rogers, Pike, Angelini, Reeves) Bristol Heart Institute, University of
Bristol, Bristol BS2 8HW, United Kingdom
Title
Use of an objective measure of time to recovery after cardiac surgery -
The STET randomised controlled trial.
Source
Trials. Conference: Clinical Trials Methodology Conference 2011 Bristol
United Kingdom. Conference Start: 20111004 Conference End: 20111005.
Conference Publication: (var.pagings). 12 , 2011. Date of Publication:
13 Dec 2011.
Publisher
BioMed Central Ltd.
Abstract
Objective: The STET trial is a two-centre open RCT comparing morbidity and
healthcare resource use when off-pump coronary artery bypass surgery is
carried out via a left anterolateral thoracotomy incision (ThoraCAB) or
via a conventional median sternotomy incision (OPCAB). It was hypothesised
that post-operative recovery would be faster with ThoraCAB. Methods:
Post-operative hospital stay is a commonly used measure of recovery.
However, in an open surgical trial, where the decision to discharge the
patient from hospital lies with the surgeon, post operative hospital stay
is susceptible to bias. For the STET trial we developed an objective
measure of recovery. Recovery time was defined as the time from surgery
until the patient was considered fit for discharge. Patients were
classified fit (a) when the x-ray was clear (no evidence of pleural
effusion requiring drainage, lung collapse/consolidation, pneumothorax);
(b) there was no suspected systemic, lower respiratory tract or wound
infection; (c) routine blood results and temperature were normal and (d)
when physically mobile (walking 70m, bowels open and oxygen
saturation>95%). These recovery criteria were monitored daily until
discharge. Results: 184 patients were recruited (91 randomised to
ThoraCAB, 93 to OPCAB). In the OPCAB group 77% were classified fit at or
before discharge versus 68% in the ThoraCAB group. For the remainder, the
recovery time was censored because discharge occurred before all the
criteria were met. Insufficient mobility accounted for the majority of
censored observations. The median recovery time was 6 days, IQR [4,7] in
the ThoraCAB group versus 5 days, IQR [4,7] in the OPCAB group (Time ratio
(ThoraCAB/OPCAB) 1.03 (95%CI [0.94, 1.14], p=0.53). In contrast, the
median time to discharge was 5 days in the ThoraCAB group versus 6 days in
the OPCAB group. Conclusion: The anticipated faster recovery with ThoraCAB
was not found and a significant proportion of patients were discharged
before all the recovery criteria were met. The results from the STET trial
illustrate the bias associated with clinical decision making in an open
RCT. The measure of recovery time (with slightly modified criteria) is
being used in other cardiac surgery trials.

<16>
Accession Number
70626945
Authors
Stocken D.D. Billingham L.J. Johnson P.J. Freemantle N.
Institution
(Stocken, Billingham, Johnson) Cancer Research UK Clinical Trials Unit,
University of Birmingham, Birmingham, United Kingdom
(Freemantle) Primary Care and Population Health, University College
London, London, United Kingdom
Title
Choice of transformation for modelling non-linear continuous biomarkers.
Source
Trials. Conference: Clinical Trials Methodology Conference 2011 Bristol
United Kingdom. Conference Start: 20111004 Conference End: 20111005.
Conference Publication: (var.pagings). 12 , 2011. Date of Publication:
13 Dec 2011.
Publisher
BioMed Central Ltd.
Abstract
Identification of prognostic and predictive biomarkers is important for
targeting treatments to patients and for the design and analysis of
randomised controlled trials. Cox proportional hazards modelling is a
standard method for assessing prognostic value of clinical biomarkers
where time to occurrence of an event is the primary outcome of interest.
An important issue in the analysis of prognostic factors is the functional
form of the relationship between the factor and outcome specifically for
continuous covariates. Continuous covariates are often simplified assuming
a linear relationship with log-hazard or dichotomisation which may be
inappropriate leading to loss of efficiency in statistical tests, bias and
incorrect conclusions. The effects of important prognostic biomarkers may
go unrecognised due to simplistic assumptions made in statistical
modelling. Two polynomial based strategies, restricted cubic splines and
fractional polynomials, are compared directly for determining the
functional form of non-linear relationships between prognostic biomarkers
and survival using two real datasets from randomised controlled trials in
advanced pancreatic cancer and cardiac surgery. Fractional polynomials are
an extended family of curves including non-integer and negative power
terms. Spline functions are piecewise polynomials connected across
intervals of a variable constrained to meet at the 'knots'. Multivariable
models were constructed based on Cox proportional hazards regression using
backward elimination. Internal validation to directly compare the fit of
the restricted cubic spline and fractional polynomial strategies was
carried out by calculating the sampling distribution of the difference in
AIC between the models using nonparametric bootstrap analyses. Further
analysis recalculated the univariate fractional polynomial transformation
within each bootstrap resample to compare directly against a 5-knot
restricted cubic spline. The influence of the size of the bootstrap
samples was also investigated. The fitted functions generated by splines
and fractional polynomials were similar resulting in comparable models.
The methods are generally different in the extremities where there is
often a paucity of data. Larger differences were seen between the two
methods when sample sizes were reduced due to the reduced power to detect
small effects but also to detect nonlinearity. Multivariable fractional
polynomial transformations are an alternative approach to restricted cubic
spline transformations for multivariable model building of continuous
biomarkers with non-linear relationships with outcome.