EMBASE Cardiac Update AutoAlert: EPICORE Cardiac Surgery Blogger2

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<1>
Accession Number
2010640240
Authors
Shiga T. Kasanuki H. Hagiwara N. Sumiyoshi T. Honda T. Haze K. Takagi A.
Kawana M. Origasa H. Ogawa H.
Institution
(Shiga, Kasanuki, Hagiwara, Takagi, Kawana, Ogawa) Department of
Cardiology, Tokyo Women's Medical University, 8-1 Kawada-cho, Shinjuku-ku,
Tokyo 162-8666, Japan
(Sumiyoshi) Sakakibara Heart Institute, Tokyo, Japan
(Honda) Saisei-kai Kumamoto Hospital, Kumamoto, Japan
(Haze) Osaka City General Hospital, Osaka, Japan
(Origasa) Division of Clinical Epidemiology and Biostatistics, Toyama
University, Toyama, Japan
Title
Angiotensin receptor blocker-based therapy and cardiovascular events in
hypertensive patients with coronary artery disease and impaired renal
function.
Source
Blood Pressure. 19 (6) (pp 359-365), 2010. Date of Publication: December
2010.
Publisher
Informa Healthcare (69-77 Paul Street, London EC2A 4LQ, United Kingdom)
Abstract
The aim of this study was to assess the effects of angiotensin receptor
blocker (ARB)-based therapy on cardiovascular events in high-risk
hypertensive patients with coronary artery disease (CAD) and impaired
renal function in post hoc analysis of HIJ-CREATE (Heart Institute of
Japan Candesartan Randomized Trial for Evaluation in Coronary Artery
Disease). Patients (n=2049) were randomly assigned to candesartan-based or
non-ARB treatment arms; 1022 patients (age 70+/-6 years, 28% female) with
impaired renal function, defined as creatinine clearance <60 ml/min at
baseline. There was no difference in major adverse cardiac event (MACE), a
composite of cardiovascular death, non-fatal myocardial infarction,
unstable angina, heart failure, stroke and other cardiovascular events
requiring hospitalization between the two arms in patients without
impaired renal function. However, there was a lower incidence of MACE in
the candesartan-based treatment arm than in the non-ARB treatment arm
(HR0.79, 95% CI 0.630.99, p0.039) in patients with impaired renal
function. Among the MACE, candesartan-based treatment reduced
hospitalization for unstable angina (HR=0.71, 95% CI 0.52-0.96, p=0.028).
Although candesartan-based treatment was not superior to non-ARB treatment
in prevention of cardiac mortality, ARB-based therapy may be beneficial in
reducing risk of coronary events in hypertensive patients with CAD and
impaired renal function. 2010 Scandinavian Foundation for Cardiovascular
Research.

<2>
Accession Number
2010648875
Authors
Benedetto U. Melina G. Refice S. Di Bartolomeo R. Roscitano A. Angeloni E.
Sinatra R.
Institution
(Benedetto, Melina, Refice, Di Bartolomeo, Roscitano, Angeloni, Sinatra)
Department of Cardiac Surgery, II School of Medicine, University of Rome
la Sapienza, Via di Grottarossa 1039, Rome, 00181, Italy
Title
Dual renin-angiotensin system blockade for patients with
prosthesis-patient mismatch.
Source
Annals of Thoracic Surgery. 90 (6) (pp 1899-1903), 2010. Date of
Publication: December 2010.
Publisher
Elsevier USA (6277 Sea Harbor Drive, Orlando FL 32862 8239, United States)
Abstract
Background Patients with prosthesis-patient mismatch (PPM) continue to
show some degrees of left ventricular hypertrophy after aortic valve
replacement for aortic stenosis. The renin-angiotensin system plays a
major role in promoting and sustaining hypertrophy. In a controlled,
randomized study, we tested the hypothesis that the combination of
angiotensin-converting enzyme inhibitors (ACEi) plus angiotensin II
receptor blocker (ARB) can be more effective in decreasing hypertrophy
than a largely employed association such as ACEi plus s-blockers in PPM
patients. Methods We enrolled a total of 72 patients with aortic valve
replacement and evidence of PPM (effective orifice area <0.85
cm²/m²) at postoperative echocardiography. At
discharge, they were randomly assigned to ramipril plus candesartan (n =
36) or ramipril plus metoprolol (n = 36). Results At baseline, age,
24-hour blood pressure, left ventricular measurements, and transprosthetic
gradients were similar between the two groups. After 12 months, the extent
of 24-hour systolic and diastolic blood pressure decrease was similar
between the two groups (-13.3% and 16.3% versus -12.3% and 15.8%,
respectively; p = 0.7 and 0.8, respectively). Left ventricular mass index
significantly decreased in both groups (ACEi plus ARB 165 +/- 19
g/m² to 117 +/- 17 g/m²; p < 0.0001; ACEi plus
beta-blockers 161 +/- 15 g/m² to 128 +/- 20 g/m²; p
< 0.0001). However, patients receiving ACEi plus ARB had a higher decrease
of left ventricular mass (-46 +/- 15 g/m² versus -35 +/- 12
g/m²; p = 0.001) and a lower rate of residual left ventricular
hypertrophy (22% versus 47%; p = 0.04). Conclusions This study shows that
in patients with PPM, the association ACEi and ARB has a greater
antiremodeling effect compared with ACEi and beta-blockers, and is
independent of blood pressure. 2010 The Society of Thoracic Surgeons.

<3>
Accession Number
2010652668
Authors
Torgersen C. Luckner G. Morgenthaler N.G. Jochberger S. Schmittinger C.A.
Wenzel V. Hasibeder W.R. Grander W. Dunser M.W.
Institution
(Torgersen, Schmittinger, Dunser) Department of Intensive Care Medicine,
Bern University Hospital, Bern, Switzerland
(Luckner, Jochberger, Wenzel) Department of Anesthesiology and Critical
Care Medicine, Innsbruck Medical University, Innsbruck, Austria
(Morgenthaler) Department of Research, B.R.A.H.M.S. Aktiengesellschaft,
Berlin, Germany
(Hasibeder) Department of Anesthesiology and Critical Care Medicine,
Krankenhaus derv Barmherzigen Schwestern, Ried im Innkreis, Austria
(Grander) Department of Internal Medicine, Community Hospital Hall in
Tirol, Hall in Tirol, Austria
Title
Plasma copeptin levels before and during exogenous arginine vasopressin
infusion in patients with advanced vasodilatory shock.
Source
Minerva Anestesiologica. 76 (11) (pp 905-912), 2010. Date of
Publication: November 2010.
Publisher
Edizioni Minerva Medica S.p.A. (Corso Bramante 83-85, Torino 10126, Italy)
Abstract
Background. Plasma copeptin levels before and during exogenous arginine
vasopressin infusion (AVP) were evaluated, and the value of copeptin
levels before AVP therapy to predict complications during AVP therapy and
outcome in vasodilatory shock patients was determined. Methods. This
prospective, observational study was nested in a randomized, controlled
trial investigating the effects of two AVP doses (0.033 vs. 0.067 IU/min)
on the hemodynamic response in patients with advanced vasodilatory shock
due to sepsis, systemic inflammatory response syndrome or after cardiac
surgery. Clinical data, plasma copeptin levels and adverse events were
recorded before, 24 hours after and 48 hours after randomization. Results.
Plasma copeptin levels were elevated before AVP therapy. During AVP,
copeptin levels decreased (P<0.001) in both groups (P=0.73). Copeptin
levels at randomization predicted the occurrence of ischemic skin lesions
(AUC ROC, 0.73; P=0.04), a fall in platelet count (AUC ROC, 0.75; P=0.01)
during AVP and intensive care unit mortality (AUC ROC, 0.67; P=0.04).
Twenty-five patients (64.1%) exhibited a decrease in copeptin levels.
Patients experiencing a decrease in copeptin levels were older (P=0.04),
had a higher Sequential Organ Failure Assessment score count before
(P=0.03) and during AVP therapy (P=0.04), had a longer intensive care unit
stay (P<0.001) and required AVP therapy longer (P=0.008) than patients
without a decrease in copeptin levels during AVP. Conclusion. Plasma
copeptin levels are elevated in patients with advanced vasodilatory shock.
During exogenous AVP therapy, copeptin levels decrease, suggesting
suppression of the endogenous AVP system.

<4>
Accession Number
2010643230
Authors
Marta G.M. Facciolo F. Ladegaard L. Dienemann H. Csekeo A. Rea F. Dango S.
Spaggiari L. Tetens V. Klepetko W.
Institution
(Marta, Klepetko) Vienna University Hospital, Vienna, Austria
(Facciolo) Regina Elena National Cancer Institute of Rome, Rome, Italy
(Ladegaard) Odense University Hospital, Odense, Denmark
(Dienemann) University Thoracic Clinic Heidelberg, Heidelberg, Germany
(Csekeo) Koranyi National Institute, Budapest, Hungary
(Rea) Thoracic Surgery University of Padua, Padua, Italy
(Dango) Albert Ludwigs University Freiburg, Freiburg, Germany
(Spaggiari) European Institute of Oncology, Milan, Italy
(Tetens) Nycomed, Roskilde, Denmark
Title
Efficacy and safety of TachoSil versus standard treatment of air leakage
after pulmonary lobectomy.
Source
European Journal of Cardio-thoracic Surgery. 38 (6) (pp 683-689), 2010.
Date of Publication: December 2010.
Publisher
Elsevier (P.O. Box 211, Amsterdam 1000 AE, Netherlands)
Abstract
Objectives: Alveolar air leakage remains a serious problem in lung
surgery, being associated with increased postoperative morbidity,
prolonged hospital stay and greater health-care costs. The aim of this
study was to evaluate the sealing efficacy and safety of the surgical
patch, TachoSil, in lung surgery. Methods: Patients undergoing
elective pulmonary lobectomy who had grade 1 or 2 air leakage (evaluated
by the water submersion test) after primary stapling and limited suturing
were randomised at 12 European centres to open-label treatment with
TachoSil or standard surgical treatment (resuturing, stapling
or no further treatment at the surgeons' discretion). Randomisation was
performed during surgery using a centralised interactive voice response
system. Duration of postoperative air leakage (primary end point),
reduction of intra-operative air leakage intensity (secondary end point)
and adverse events (AEs), including postoperative complications, were
assessed. Results: A total of 486 patients were screened and 299 received
trial treatment (intent-to-treat (ITT) population: TachoSil,
n=148; standard treatment, n=151). TachoSil resulted in a
reduction in the duration of postoperative air leakage (p=0.030). Patients
in the TachoSil group also experienced a greater reduction in
intra-operative air leakage intensity (p=0.042). Median time until chest
drain removal was 4 days with TachoSil and 5 days in the
standard group (p=0.054). There was no difference between groups in
hospital length of stay. AEs were generally similar in both groups,
including postoperative complications. Conclusions: TachoSil
was superior to standard surgical treatment in reducing both postoperative
air leakage duration and intra-operative air leakage intensity in patients
undergoing elective pulmonary lobectomy. 2010 European Association for
Cardio-Thoracic Surgery.

<5>
Accession Number
2010643241
Authors
Ovrum E. Tangen G. Tollofsrud S. Oystese R. Ringdal M.A.L. Istad R.
Institution
(Ovrum, Tangen, Tollofsrud, Oystese, Ringdal, Istad) Oslo Heart Center,
Division of Cardiovascular and Respiratory Medicine and Surgery, Oslo
University Hospital, Rikshospitalet, Box 2684, St. Hanshaugen, 0131 Oslo,
Norway
Title
Cold blood versus cold crystalloid cardioplegia: A prospective randomised
study of 345 aortic valve patients.
Source
European Journal of Cardio-thoracic Surgery. 38 (6) (pp 745-749), 2010.
Date of Publication: December 2010.
Publisher
Elsevier (P.O. Box 211, Amsterdam 1000 AE, Netherlands)
Abstract
Objective: Although experimental studies have indicated that blood
cardioplegia may be superior to crystalloid cardioplegia for myocardial
protection, clinical data still remain uncertain. In a previous randomised
study from our institution, including 1440 patients undergoing coronary
artery bypass grafting (CABG), no beneficial effects of blood cardioplegia
were seen in any relevant outcome variables. The investigation was
therefore extended to a patient population having longer pump times and
ischaemic periods. Methods: Over a 48-month period, all patients
undergoing aortic valve replacement with or without CABG performed by two
surgeons, were prospectively randomised to receive either intermittent
cold retrograde blood cardioplegia (group B) or intermittent cold
retrograde crystalloid cardioplegia (group C) during aortic
cross-clamping. Results: A total of 345 patients aged 28-90 years (median,
72 years) entered the study (group B, n= 172, group C, n= 173). All
relevant demographic and operative variables were similar for both groups.
As for the clinical course, no statistically significant differences were
seen concerning spontaneous sinus rhythm after aortic declamping, use of
inotropic drugs, duration of ventilatory support, bleeding and rate of
allogeneic blood transfusions, perioperative myocardial infarction,
episodes of atrial fibrillation, stroke or minor neurological dysfunction,
renal function, infections, physical rehabilitation or mortality. Further,
in the patients with the longest ischaemic times, no statistically
significant differences between the groups could be demonstrated.
Conclusions: There were no indications that retrograde cold blood
cardioplegia was superior to retrograde cold crystalloid cardioplegia
patients undergoing aortic valve replacement, with or without CABG. 2010
European Association for Cardio-Thoracic Surgery.

<6>
Accession Number
2010643244
Authors
Marberg H. Jeppsson A. Brandrup-Wognsen G.
Institution
(Marberg, Jeppsson, Brandrup-Wognsen) Department of Cardiovascular Surgery
and Anesthesia, Sahlgrenska University Hospital, Gothenburg, Sweden
(Jeppsson, Brandrup-Wognsen) Department of Molecular and Clinical
Medicine, Institute of Medicine, University of Gothenburg, Sahlgrenska
Academy, Gothenburg, Sweden
Title
Postoperative autotransfusion of mediastinal shed blood does not influence
haemostasis after elective coronary artery bypass grafting.
Source
European Journal of Cardio-thoracic Surgery. 38 (6) (pp 767-772), 2010.
Date of Publication: December 2010.
Publisher
Elsevier (P.O. Box 211, Amsterdam 1000 AE, Netherlands)
Abstract
Objectives: The rationale of using autotransfusion of mediastinal shed
blood after cardiac surgery is to preserve haemoglobin levels and reduce
the need for allogenic blood transfusions. However, the method is
controversial and its clinical value has been questioned. We hypothesised
that re-transfusion of mediastinal shed blood instead impairs haemostasis
after routine coronary artery bypass grafting and thus increases
postoperative bleeding. Methods: Seventy-seven consecutive elective
coronary artery bypass surgery patients (mean age 67+/-9 years, 77% men)
were included in a prospective, randomised controlled study. The patients
were randomised to postoperative re-transfusion of mediastinal shed blood
(n=39) or to a group where mediastinal shed blood was discarded (n=38).
Primary end point was bleeding during the first 12 postoperative hours.
Secondary end points were postoperative transfusion requirements,
haemoglobin levels, thrombo-elastometric variables and plasma
concentrations of interleukin-6, thrombin-anti-thrombin complex and
D-dimer. Results: Mean re-transfused volume in the autotransfusion group
was 282+/-210ml. There was no difference in postoperative bleeding (median
394ml (interquartile range 270-480) vs 385 (255-430) ml, p=0.69),
proportion of patients receiving transfusions of blood products (11/39 vs
11/38, p=0.95), haemoglobin levels 24h after surgery (116+/-13 vs
116+/-14gl^-1, p=0.87), thrombo-elastometric variables,
interleukin-6 (219+/-144 vs 201+/-144 pgml^-1, p=0.59),
thrombin-anti-thrombin complex (11.0+/-9.1 vs 14.8+/-15, p=0.19) or
D-dimer (0.56+/-0.49 vs 0.54+/-0.44, p=0.79) between the autotransfusion
group and the no-autotransfusion group. Conclusions: Autotransfusion of
small-to-moderate amounts of mediastinal shed blood does not influence
haemostasis after elective coronary artery bypass grafting. 2010.

<7>
Accession Number
2010645188
Authors
Melloni C. Rao S.V. Povsic T.J. Melton L. Kim R.J. Kilaru R. Patel M.R.
Talan M. Ferrucci L. Longo D.L. Lakatta E.G. Najjar S.S. Harrington R.A.
Institution
(Melloni, Rao, Povsic, Kim, Patel, Harrington) Department of Medicine,
School of Medicine, Duke University, Durham, NC, United States
(Melloni, Rao, Povsic, Melton, Kim, Kilaru, Patel, Harrington) Duke
Clinical Research Institute, Duke University Medical Center, Durham, NC,
United States
(Rao) Durham Veterans Affairs Medical Center, Durham, NC, United States
(Talan, Ferrucci, Longo, Lakatta, Najjar) Intramural Research Program,
National Institute on Aging, National Institutes of Health, Baltimore, MD,
United States
(Najjar) MedStar Health Research Institute, Washington, DC, United States
Title
Design and rationale of the Reduction of Infarct Expansion and Ventricular
Remodeling with Erythropoietin after Large Myocardial Infarction (REVEAL)
trial.
Source
American Heart Journal. 160 (5) (pp 795-803.e1-e2), 2010. Date of
Publication: November 2010.
Publisher
Mosby Inc. (11830 Westline Industrial Drive, St. Louis MO 63146, United
States)
Abstract
Background: Acute myocardial infarction (MI) remains a leading cause of
death despite advances in pharmacologic and percutaneous therapies. Animal
models of ischemia/reperfusion have demonstrated that single-dose
erythropoietin may reduce infarct size, decrease apoptosis, and increase
neovascularization, possibly through mobilization of endothelial
progenitor cells. Study Design: REVEAL is a randomized, double-blind,
placebo-controlled, multicenter trial evaluating the effects of epoetin
alpha on infarct size and left ventricular remodeling in patients with
large MIs. The trial comprises a dose-escalation safety phase and a
single-dose efficacy phase using the highest acceptable epoetin alpha dose
up to 60,000 IU. Up to 250 ST-segment elevation myocardial infarction
patients undergoing primary or rescue percutaneous coronary intervention
will be randomized to intravenous epoetin alpha or placebo within 4 hours
of successful reperfusion. The primary study end point is infarct size
expressed as a percentage of left ventricular mass, as measured by cardiac
magnetic resonance imaging 2 to 6 days post study medication
administration. Secondary end points will assess changes in endothelial
progenitor cell numbers and changes in indices of ventricular remodeling.
Conclusion: The REVEAL trial will evaluate the safety and efficacy of the
highest tolerated single dose of epoetin alpha in patients who have
undergone successful rescue or primary percutaneous coronary intervention
for acute ST-segment elevation myocardial infarction. 2010 Mosby, Inc.

<8>
Accession Number
2010648535
Authors
Elmorsy G.Z. El Gamal M.-A.F.
Institution
(Elmorsy) Anesthesia and Surgical Intensive Care Department, Faculty of
Medicine, Mansoura University, Egypt
(El Gamal) Department of Pediatric and Congenital Cardiothoracic Surgery,
Faculty of Medicine, Mansoura University, Egypt
Title
Effect of different doses of cisatracurium on intubating conditions during
inhalation induction with sevoflurane in pediatric cardiac surgery.
Source
Egyptian Journal of Anaesthesia. 25 (2) (pp 107-114), 2009. Date of
Publication: 2009.
Publisher
Central Society of Egyptian Anaesthesiologists (P.O. Box 167, Panorama
October 11811, Nasr City, Cairo, Egypt)
Abstract
Background: This prospective, randomized, double-blind study was designed
to study the effect of different doses of cisatracurium on intubation
conditions in children during induction with sevoflurane anesthesia in
cases scheduled for elective cardiac surgery at Mansoura Children's
University Hospital. Methods: One hundred children, ASA II-III, aged (2-6)
years subjected for elective cardiac surgery at mansoura children's
university hospital were enrolled in this study. The patients were
randomly allocated using closed envelop method to receive cisatracurium
(0.1(2xED95), 0.05(ED95), 0.025(0.5xED95) mg/kg) or placebo, each one
consisted of 25 patients. Intubation conditions were assessed 3 min after
drug injection. Hemodynamic variables (heart rate and mean arterial
pressure) were recorded. Results: Intubating conditions were considered
good only in 20% of patients with inhalational induction only,
cisatracurium 0.025mg/kg results in good intubating conditions in 52% of
patients, cisatracurium 0.05mg/kg results in good intubating conditions in
60% of patients and excellent intubating conditions in 12% of patients,
while cisatracurium 0.1mg/kg results in excellent intubating condition in
80% of patients and good intubating conditions in 20% of patients.
Conclusion: We concluded that after 3 min after injection of cisatracurium
or placebo, intubation conditions were acceptable in 100, 70, 50, 20% of
children according to the dose of cisatracurium (0.1, 0.05, 0.025 mg/kg or
saline) respectively. Cisatracurium in a dose of 0.1mg/kg considered to be
the proper intubating dose with better hemodynamic stability in pediatric
cardiac surgery.

<9>
Accession Number
2010648540
Authors
Asaad O.M. El Menesy T.M. Hamden G.A. Abdou S.A. Labib D.A. Al Abd N.E.
Abdallah T.S. Hanafy M.S.
Institution
(Asaad, Hamden, Abdou) Department of Anesthesia, Cairo University, Egypt
(Abdallah) Department of Cardiothoracic Surgery, Cairo University, Egypt
(Labib, Al Abd) Department of Clinical Pathology, Cairo University, Egypt
(El Menesy) Department of Anesthesia, Beni Suef University, Egypt
(Hanafy) Department of Cardiothoracic Surgery, Zagazeg University, Egypt
Title
Dexamethasone in a fixed multimodal analgesic regimen following OPCAB
surgery. A randomized, double-blind, comparative study on pain and
neuroendocrine stress hormones control.
Source
Egyptian Journal of Anaesthesia. 25 (2) (pp 161-172), 2009. Date of
Publication: 2009.
Publisher
Central Society of Egyptian Anaesthesiologists (P.O. Box 167, Panorama
October 11811, Nasr City, Cairo, Egypt)
Abstract
Objective: In this study, the efficacy of including dexamethasone 8 mg in
a fixed multimodal analgesic regimen on postoperative neuroendocrine
hormonal assay and pain control was evaluated by using the parasternal
block together with both morphine and paracetamol supplements in cardiac
surgical patients. Methods: Forty five patients undergoing Off pump
coronary artery bypass graft surgery (OPCAB) were randomly allocated into
three groups (15 patients in each); Bupivacaine (B group), Bupivacaine and
dexamethasone 8 mg (BD group) and control (C group). The studied drugs
were injected in both parasternal block (30 ml) and around chest tube
sites (10 ml). The study was designed to supplement the block with both
morphine boluses when Prince Henry score exceeds 2 and paracetamol
infusion every 6 hours. The changes in hormonal levels including both
cortisol and epinephrine were traced before the block and at 12 hour
postoperatively. Also, the time to first morphine request and its total
dose used were calculated in 24 hours and compared between the studied
groups. Results: Both cortisol and epinephrine values were higher in the
control group at 12 hour when compared to the bupivacaine treated groups.
The time to first analgesic request was prolonged and the total morphine
consumption was reduced in BD group when compared to the other two groups.
Also, the prince Henry scores for pain were lower at 6 and 8 hours in BD
and B groups when compared to control group. The mean arterial blood
pressure MAP was higher in the control group in comparison to the other
two groups at 6 and 8 hours. No side effects were detected among studied
groups. Conclusions: The multimodal approach using
dexamethasone-bupivacaine parasternal block together with both morphine
boluses according to PHS and regular paracetamol infusion resulted in less
neuroendocrine hormonal levels, postoperative pain and morphine
consumption with stable hemodynamics following OPCAP surgery.

<10>
Accession Number
2010640434
Authors
Parsaik A.K. Murad M.H. Sathananthan A. Moorthy V. Erwin P.J. Chari S.
Carter R.E. Farnell M.B. Vege S.S. Sarr M.G. Kudva Y.C.
Institution
(Parsaik, Sathananthan, Moorthy, Kudva) Endocrinology, Mayo Clinic,
Rochester, MN, United States
(Murad) Preventive Medicine, Mayo Clinic, Rochester, MN, United States
(Erwin) Knowledge and Encounter Research Unit, Mayo Clinic, Rochester, MN,
United States
(Chari) Gastroenterology, Mayo Clinic, Rochester, MN, United States
(Carter, Vege) Biomedical Statistics and Informatics, Mayo Clinic,
Rochester, MN, United States
(Farnell, Sarr) Gastroenterologic and General Surgery, Mayo Clinic, 200
First Street SW, Rochester, MN 55902, United States
Title
Metabolic and target organ outcomes after total pancreatectomy: Mayo
Clinic experience and meta-analysis of the literature.
Source
Clinical Endocrinology. 73 (6) (pp 723-731), 2010. Date of Publication:
December 2010.
Publisher
Blackwell Publishing Ltd (9600 Garsington Road, Oxford OX4 2XG, United
Kingdom)
Abstract
Total pancreatectomy (TP) has been associated with substantial metabolic
abnormalities and poor glycaemic control limiting its use. Because data
reported to date are limited, we evaluated outcomes related to the
diabetes mellitus obligated by TP. Methods: A case series study of all
patients who underwent TP from 01/01/1985 to 12/31/2006 at Mayo Clinic was
conducted. TP cases were summarized according to perioperative procedures,
mortality and morbidity after TP. To complement this retrospective
examination, a survey was developed to measure DM treatment modality,
target organ failure and complications in patients alive in 2007. We
performed a meta-analysis to compare our results with similar previous
studies and provide overall estimates of outcomes. Results: A total of 141
cases were studied (97 malignant diseases, 44 benign diseases). The median
survival was much less for malignant pathology (22 vs 87 years, Log rank P
= 00009). In 2007, there were 59 patients that were presumed alive and 47
(80%) responded to the survey. Mean HbA1c at last follow-up was 75% with
89% of respondents on a complex insulin programme (mean daily insulin
requirement 35 +/- 13 units). Episodic hypoglycaemia was experienced by 37
(79%); 15 (41%) experienced severe hypoglycaemia. In contrast, diabetic
ketoacidosis developed in only 2 (4%). Target organ complications and
chronic diarrhoea developed in 13 patients (28%) each. Conclusion: The
primary factor determining survival after TP is the aetiology
necessitating TP, i.e. pancreatic malignancy. Most respondents used
complex insulin programmes, but hypoglycaemia continues to be a problem.
2010 Blackwell Publishing Ltd.

<11>
Accession Number
2010640954
Authors
Mantovani V. Lepore V. Mira A. Berglin E.
Institution
(Mantovani) Department of Cardiac Surgery, University of Insubria,
Ospedale di Circolo di Varese, Viale Borri 57, 21100 Varese, Italy
(Lepore, Berglin) Department of Cardio-Thoracic Surgery, Sahlgrenska
University Hospital, Goteborg, Sweden
(Mira) Department of Economics, University of Insubria, Varese, Italy
Title
Non-inferiority randomized trials, an issue between science and ethics:
The case of the SYNTAX study.
Source
Scandinavian Cardiovascular Journal. 44 (6) (pp 321-324), 2010. Date of
Publication: December 2010.
Publisher
Informa Healthcare (69-77 Paul Street, London EC2A 4LQ, United Kingdom)
Abstract
Non-inferiority trials are questionable when death and serious
complications are included among outcomes. The term itself "non-
inferiority" is misleading, since such a study would not demonstrate that
a new treatment is non-inferior to a control treatment, but simply that
the inferiority would not reach a pre-specified level, deemed as
acceptable by the designers of the trial. Group cross-over,
assay-sensitivity and the need of a placebo arm are major issues for the
reliability of non-inferiority trials. The SYNTAX trial for severe
coronary artery disease was designed on a non-inferiority margin of 6.6%.
In this paper we show that the SYNTAX designers were ready to accept up to
30% higher rate of death and major adverse events to claim the
non-inferiority of percutaneous coronary intervention versus coronary
artery bypass grafting. Eventually the SYNTAX study failed because
percutaneous patients sustained an even higher rate of adverse events. We
propose major caution in performing non-inferiority randomized trials.
2010 Informa Healthcare.

<12>
Accession Number
2010628870
Authors
Nishihira K. Shibata Y. Ishikawa T. Nomura K. Nakama T. Mine D. Inoue Y.
Ashikaga K. Kuriyama N. Matsuyama A. Imamura T. Asada Y. Kitamura K.
Institution
(Nishihira, Shibata, Nomura, Nakama, Mine, Inoue, Ashikaga, Kuriyama,
Matsuyama) Department of Cardiology, Medical Association Hospital
University of Miyazaki, Miyazaki, Japan
(Nishihira, Ishikawa, Matsuyama, Imamura, Kitamura) Division of
Circulatory and Body Fluid Regulation, Department of Internal Medicine,
University of Miyazaki, Miyazaki, Japan
(Asada) Department of Pathology, Faculty of Medicine, University of
Miyazaki, Miyazaki, Japan
Title
Repeated sirolimus-eluting stent implantation to treat sirolimus-eluting
stent and bare-metal stent restenosis.
Source
Circulation Journal. 74 (11) (pp 2329-2333), 2010. Date of Publication:
November 2010.
Publisher
Japanese Circulation Society (14 Yoshida Kawaharacho, Sakyo-ku, Kyoto 606,
Japan)
Abstract
Background: In-stent restenosis (ISR) remains a persistent, unresolved
issue even in the era of percutaneous coronary intervention (PCI) using
drug-eluting stents. The present study compares the clinical and
angiographic outcomes of using sirolimus-eluting stents (SES) for
re-intervention against ISR that was originally treated with
sirolimus-eluting or bare-metal (BMS) stents. Methods and Results: This
prospective single-center registry investigated 179 ISR lesions in 158
consecutive patients (53 lesions in 49, and 126 in 109 patients originally
treated with SES and BMS, respectively), who had undergone re-intervention
with SES. The patients were clinically and angiographically followed up at
8 months after re-PCI. The incidence of re-restenosis (29 vs 12%, P<0.01),
ischemia-driven target lesion revascularization (TLR; 21 vs 8%, P<0.05)
and major adverse cardiac events (MACE; 21 vs 9%, P<0.05) were
significantly greater in ISR lesions originally treated with SES than in
those originally treated with BMS at 8 months after re-PCI. Moreover, late
luminal loss was significantly greater in the group with post-SES
restenosis (P<0.05). Even after adjustment, post-SES restenosis was the
only independent predictor of re-restenosis and MACE (P<0.05, each).
Conclusions: Although the re-restenosis rate is acceptable, the incidence
rates of late restenosis, ischemiadriven TLR and MACE are higher after
repeated SES implantation to treat SES, than BMS restenosis. These results
might affect the mid-term clinical outcomes of re-intervention with SES.

<13>
Accession Number
2010641759
Authors
Penninga L. Moller C.H. Gustafsson F. Steinbruchel D.A. Gluud C.
Institution
(Penninga, Moller, Gluud) Department 3344, Rigshospitalet, Copenhagen
University Hospital, Copenhagen, Denmark
(Penninga) Department of Surgery and Transplantation C2122,
Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark
(Moller, Steinbruchel) Department of Cardiothoracic Surgery RT 2152,
Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark
(Gustafsson) Department of Cardiology, B2142, Rigshospitalet, Copenhagen
University Hospital, Copenhagen, Denmark
Title
Tacrolimus versus cyclosporine as primary immunosuppression after heart
transplantation: Systematic review with meta-analyses and trial sequential
analyses of randomised trials.
Source
European Journal of Clinical Pharmacology. 66 (12) (pp 1177-1187), 2010.
Date of Publication: December 2010.
Publisher
Springer Verlag (Tiergartenstrasse 17, Heidelberg D-69121, Germany)
Abstract
Purpose: We conducted a systematic review of randomized trials to compare
the benefits and harms of tacrolimus versus cyclosporine as primary
immunosuppression after heart transplantation. Methods and results: We
searched electronic databases and bibliographies up to April 2010. Our
review followed the Cochrane and PRISMA guidelines. The meta-analysis
included 10 randomized trials with 952 patients. Tacrolimus was
significantly superior to cyclosporine (both formula-combined) with regard
to hypertension (relative risk [RR] 0.8; 95% confidence interval [CI]
0.69-0.93, p = 0.003), hyperlipidaemia (RR 0.57; 95% CI 0.44-0.74, p <
0.0001), hirsutism (RR 0.17 95% CI 0.04-0.62, p = 0.008), and gingival
hyperplasia (RR 0.07 95% CI 0.01-0.37, p = 0.002). No significant
differences between the two calcineurin inhibitors were found with regard
to acute rejections causing haemodynamic instability, diabetes, renal
dysfunction, infection, malignancy, or neurotoxicity. Tacrolimus was
significantly superior to microemulsion cyclosporine with regard to
mortality (RR 0.64; 95% CI 0.42-0.96, p = 0.03), acute severe
biopsy-proven rejection (RR 0.71; 95% CI 0.56-0.90, p = 0.004),
hyperlipidaemia (RR 0.57; 95% CI 0.41-0.79, p = 0.0009), hirsutism (RR
0.17 95% CI 0.04-0.62, p = 0.008), and gingival hyperplasia (RR 0.07; 95%
CI 0.01-0.37, p = 0.002). Tacrolimus was significantly superior to
oil-based cyclosporine with regard to hypertension (RR 0.66; 95% CI
0.54-0.80, p < 0.0001), and hyperlipidaemia (RR 0.57; 95% CI 0.38-0.87, p
= 0.009). Conclusion: Tacrolimus seems to be superior to cyclosporine in
heart transplant patients with regard to hypertension, hyperlipidaemia,
gingival hyperplasia and hirsutism. In addition, tacrolimus seems to be
superior to microemulsion cyclosporine in heart transplant patients with
regard to a number of outcomes, including death. More trials with a low
risk of bias are needed to determine if the results of the present
meta-analysis can be confirmed. 2010 Springer-Verlag.