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<1>
Accession Number
2011439804
Authors
Fletcher K.E. Reed D.A. Arora V.M.
Institution
(Fletcher) Department of Medicine, Milwaukee VAMC/Medical College of
Wisconsin, Clement J. Zablocki VAMC, 5000 W. National Ave, Milwaukee, WI
53295, United States
(Reed) Department of Medicine, Mayo Clinic College of Medicine, Rochester,
MN, United States
(Arora) Department of Medicine, University of Chicago, Pritzker School of
Medicine, Chicago, IL, United States
Title
Patient safety, resident education and resident well-being following
implementation of the 2003 ACGME duty hour rules.
Source
Journal of General Internal Medicine. 26 (8) (pp 907-919), 2011. Date of
Publication: August 2011.
Publisher
Springer New York (233 Springer Street, New York NY 10013-1578, United
States)
Abstract
Context: The ACGME-released revisions to the 2003 duty hour standards.
Objective: To review the impact of the 2003 duty hour reform as it
pertains to resident and patient outcomes. Data Sources: Medline (1989-May
2010), Embase (1989-June 2010), bibliographies, pertinent reviews, and
meeting abstracts. Study Selection: We included studies examining the
relationship between the pre- and post-2003 time periods and patient
outcomes (mortality, complications, errors), resident education
(standardized test scores, clinical experience), and well-being (as
measured by the Maslach Burnout Inventory). We excluded non-US studies.
Data Extraction: One rater used structured data collection forms to
abstract data on study design, quality, and outcomes. We synthesized the
literature qualitatively and included a meta-analysis of patient
mortality. Results: Of 5,345 studies identified, 60 met eligibility
criteria. Twenty-eight studies included an objective outcome related to
patients; 10 assessed standardized resident examination scores; 26
assessed resident operative experience. Eight assessed resident burnout.
Meta-analysis of the mortality studies revealed a significant improvement
in mortality in the post-2003 time period with a pooled odds ratio (OR) of
0.9 (95% CI: 0.84, 0.95). These results were significant for medical (OR
0.91; 95% CI: 0.85, 0.98) and surgical patients (OR 0.86; 95% CI: 0.75,
0.97). However, significant heterogeneity was present (I² 83%).
Patient complications were more nuanced. Some increased in frequency;
others decreased. Outcomes for resident operative experience and
standardized knowledge tests varied substantially across studies. Resident
well-being improved in most studies. Limitations: Most studies were
observational. Not all studies of mortality provided enough information to
be included in the meta-analysis. We used unadjusted odds ratios in the
meta-analysis; statistical heterogeneity was substantial. Publication bias
is possible. Conclusions: Since 2003, patient mortality appears to have
improved, although this could be due to secular trends. Resident
well-being appears improved. Change in resident educational experience is
less clear. 2011 Society of General Internal Medicine.

<2>
Accession Number
2011406823
Authors
Cameli M. Lisi M. Mondillo S. Padeletti M. Ballo P. Bigio E. Marchetti L.
Biagioli B.
Institution
(Cameli, Lisi, Mondillo, Padeletti) Department of Cardiovascular Diseases,
University of Siena, Siena, Italy
(Ballo) Cardiology Operative Unit, S. Maria Annunziata Hospital, Firenze,
Italy
(Bigio, Marchetti, Biagioli) Unit of Anesthesia and Intensive Care Unit,
Department of Surgery and Bioengineering, University of Siena, Siena,
Italy
Title
Prediction of stroke volume by global left ventricular longitudinal strain
in patients undergoing assessment for cardiac transplantation.
Source
Journal of Critical Care. 26 (4) (pp 433.e13-433.e20), 2011. Date of
Publication: August 2011.
Publisher
W.B. Saunders (Independence Square West, Philadelphia PA 19106-3399,
United States)
Abstract
Purpose: Speckle-tracking echocardiography (STE) is a novel technique that
can be used for assessment of left ventricular (LV) longitudinal
deformation dynamics. Using cardiac catheterization as the reference
standard, the aim of this study was to evaluate the relation between LV
global longitudinal strain (GLS) assessed by STE and LV stroke volume in
patients undergoing assessment for cardiac transplantation. Methods:
Conventional echocardiography and STE were performed during right-sided
cardiac catheterization in 51 patients referred for cardiac transplant
assessment. Thermodilution LV stroke volume indexed (LVSVI) was used as
the reference standard. Univariate regression analyses and receiver
operating characteristics curves were used to test correlations between
LVSVI and GLS by STE. Results: Global longitudinal strain was obtained
successfully in 95.5% of patients. Among all variables analyzed, GLS best
predicted the LVSVI (r = 0.79; P <.0001). Minor correlations with the
LVSVI were observed for tissue Doppler-derived systolic mitral annular
velocity (r = 0.51; P <.005) and for LV ejection fraction (r = 0.32; P
<.05). Conclusions: In a group of patients referred for cardiac transplant
assessment, LV longitudinal deformation analysis by STE closely correlates
with LVSVI, suggesting that, in this particular clinical setting, this new
parameter may help provide an accurate, noninvasive, and quantitative
assessment of LV function. 2011 Elsevier Inc.

<3>
Accession Number
2011413642
Authors
Wu Q. Gui P. Wu J. Ding D. Purusram G. Dong N. Yao S.
Institution
(Wu, Gui, Wu, Ding, Purusram, Yao) Department of Anesthesiology, Union
Hospital, Tongji Huazhong University of Science and Technology, Wuhan,
China
(Dong) Department of Cardiovascular Surgery (N.D.), Union Hospital, Tongji
Huazhong University of Science and Technology, Wuhan, China
Title
Effect of limb ischemic preconditioning on myocardial injury in patients
undergoing mitral valve replacement surgery: A randomized controlled
trial.
Source
Circulation Journal. 75 (8) (pp 1885-1889), 2011. Date of Publication:
August 2011.
Publisher
Japanese Circulation Society (14 Yoshida Kawaharacho, Sakyo-ku, Kyoto 606,
Japan)
Abstract
Background: Whether limb ischemic preconditioning (LIPC) is beneficial for
patients undergoing mitral valve replacement (MVR) surgery is unknown.
Methods and Results: Seventy-five adult patients undergoing MVR surgery
were randomly assigned to 3 groups: control group (n=25), LIPC group I
(3x5-min cycles of right upper arm ischemia and 5-min reperfusion; n=25)
and LIPC group II (3x5-min cycles of right upper arm ischemia and 5-min
reperfusion combined with 2x10-min cycles of right upper leg ischemia and
10-min reperfusion; n=25). Cardiopulmonary bypass (CPB) time, cross-clamp
time, cardiac index, cumulative postoperative dosage of dobutamine,
intensive care stay, postoperative hospital stay were not statistically
different. Although the cumulative postoperative dosage of dobutamine was
not different, there was a significantly lower inotropic requirement in
LIPC II compared with the control group at 4 and 8 h after surgery. Plasma
levels of cardiac troponin-I in the 3 groups significantly increased
during CPB and peaked at 4 h after surgery. Levels of cTnI in LIPC II were
significantly lower than in the control group at each time point after
surgery. Conclusions: Myocardial injury is obvious after MVR surgery. LIPC
can protect the myocardium from ischemia-reperfusion injury and decrease
the inotropic requirement after surgery. The data also confirmed the
requirement for the preconditioning stimulus to cross a threshold.

<4>
Accession Number
2011397959
Authors
Takagi H. Umemoto T.
Institution
(Takagi, Umemoto) Department of Cardiovascular Surgery, Shizuoka Medical
Center, 762-1 Nagasawa, Shimizu-cho, Sunto-gun, Shizuoka 411-8611, Japan
Title
A meta-analysis of randomized trials and adjusted observational studies of
drug-eluting stents versus coronary artery bypass grafting for unprotected
left main coronary artery disease.
Source
International Journal of Cardiology. 150 (3) (pp 341-343), 2011. Date of
Publication: 04 Aug 2011.
Publisher
Elsevier Ireland Ltd (P.O. Box 85, Limerick, Ireland)

<5>
Accession Number
2011397954
Authors
Biondi-Zoccai G. Lotrionte M. Agostoni P. Abbate A. Romagnoli E. Sangiorgi
G. Angiolillo D.J. Valgimigli M. Testa L. Gaita F. Sheiban I.
Institution
(Biondi-Zoccai, Gaita, Sheiban) Division of Cardiology, University of
Turin, San Giovanni Battista Molinette Hospital, Corso Bramante 88-90,
10126 Turin, Italy
(Lotrionte) Unit for Heart Failure and Cardiac Rehabilitation, Catholic
Universty, Rome, Italy
(Agostoni) Division of Cardiology, University Medical Center Utrecht,
Utrecht, Netherlands
(Abbate) VCU Pauley Heart Center, Richmond, VA, United States
(Romagnoli) Division of Cardiology, Policlinico Casilino, Rome, Italy
(Sangiorgi) Division of Cardiology, University of Modena, Modena, Italy
(Angiolillo) Division of Cardiology, Department of Medicine, University of
Florida College of Medicine-Jacksonville, Shands Jacksonville, FL, United
States
(Valgimigli) Division of Cardiology, University of Ferrara, Ferrara, Italy
(Testa) Department of Interventional Cardiology, Clinical Institute S.
Ambrogio, Milan, Italy
Title
Adjusted indirect comparison meta-analysis of prasugrel versus ticagrelor
for patients with acute coronary syndromes.
Source
International Journal of Cardiology. 150 (3) (pp 325-331), 2011. Date of
Publication: 04 Aug 2011.
Publisher
Elsevier Ireland Ltd (P.O. Box 85, Limerick, Ireland)
Abstract
Background: Clopidogrel is beneficial after ACS. Recent data suggest the
superiority of prasugrel or ticagrelor compared with clopidogrel. However,
there is no comparison of prasugrel vs. ticagrelor. We performed an
adjusted indirect meta-analysis comparing prasugrel vs. ticagrelor for
acute coronary syndromes (ACSs). Methods: Randomized trials were searched
in PubMed. The primary end-point was the composite of death, myocardial
infarction (MI) or stroke. Odds ratios (OR) were computed (95% confidence
intervals). Results: Three trial (32,893) patients were included. Overall,
either prasugrel or ticagrelor appeared significantly superior to
clopidogrel for the 12-month risk of death, MI or stroke (OR = 0.83
[0.77-0.89], p < 0.001), death (OR = 0.83 [0.74-0.93], p = 0.001), MI (OR
= 0.79 [0.73-0.86], p < 0.001), and stent thrombosis (OR = 0.61
[0.51-0.74], p < 0.001), without any significant difference in stroke or
major bleeding (both p > 0.05), despite more frequent drug discontinuation
(OR = 1.12 [1.05-1.19], p < 0.001). Head-to-head comparison of prasugrel
vs. ticagrelor showed no significant differences in overall death, MI,
stroke, or their composite (all p > 0.05). Prasugrel was associated with a
significantly lower risk of stent thrombosis (OR = 0.64 [0.43-0.93], p =
0.020). Ticagrelor was associated with a significantly lower risk of any
major bleeding (OR = 1.43 [1.10-1.85], p = 0.007), and major bleeding
associated with bypass grafting (OR = 4.30 [1.73-10.6], p = 0.002).
However, the more clinically relevant risk of major bleeding not related
to bypass surgery was similar with either prasugrel or ticagrelor (OR =
1.06 [0.77-1.45], p = 0.34). Conclusions: Prasugrel and ticagrelor are
superior to clopidogrel for ACS. Head-to-head comparison suggests similar
efficacy and safety of prasugrel and ticagrelor, but prasugrel appears
more protective from stent thrombosis, while causing more bleedings. 2010
Elsevier Ireland Ltd.

<6>
Accession Number
2011433202
Authors
Catford S.R. Lee K.T. Pace M.D. Marasco S.F. Longano A. Topliss D.J.
Institution
(Catford, Lee, Pace, Topliss) Department of Endocrinology and Diabetes,
Monash University, Alfred Health, Melbourne, VIC 3004, Australia
(Marasco) Department of Cardiothoracic Surgery, Alfred Health, Melbourne,
VIC, Australia
(Marasco) Department of Surgery, Monash University, Melbourne, VIC,
Australia
(Longano) Department of Anatomical Pathology, Alfred Health, Melbourne,
VIC, Australia
(Topliss) Department of Medicine, Monash University, Melbourne, VIC,
Australia
Title
Cardiac metastasis from thyroid carcinoma.
Source
Thyroid. 21 (8) (pp 855-866), 2011. Date of Publication: 01 Aug 2011.
Publisher
Mary Ann Liebert Inc. (140 Huguenot Street, New Rochelle NY 10801-5215,
United States)
Abstract
Cardiac metastasis from epithelial thyroid cancer is a very rare and
potentially serious complication. We have identified only 54 reported
cases over a 130-year period. Here we review this literature. Cardiac
metastases are frequently asymptomatic, but when symptoms develop these
tend to be severe and often fatal. The prognosis of cardiac metastases
from thyroid cancer is unclear as survival data are often missing or
absent in reported cases. However, as many patients died suddenly from
cardiac complications, the prognosis seems poor. Of those patients who
survived, all underwent surgical intervention. Trans-thoracic
echocardiography is the diagnostic modality of choice as it allows dynamic
evaluation of intracardiac masses. Metastatic involvement of the heart
from thyroid cancer is uncommon. Left untreated this complication seems
likely to be fatal. Therefore, in patients with established thyroid
malignancy who develop cardiac arrhythmias, new murmurs, or signs of
cardiac decompensation, we suggest that cardiac metastases be considered.
Echocardiography should be performed in patients with advanced thyroid
cancer and cardiac symptoms or signs. If a cardiac metastasis is present,
we recommend surgical intervention if possible. Copyright 2011, Mary Ann
Liebert, Inc.

<7>
Accession Number
2011430562
Authors
Sensoz Y. Gunay R. Tuygun A.K. Balci A.Y. Sahin S. Kayacioglu I. Alkan P.
Yekeler I.
Institution
(Sensoz, Gunay, Tuygun, Balci, Kayacioglu, Alkan, Yekeler) Department of
Cardiovascular Surgery, Dr. Siyami Ersek Thoracic and Cardiovascular
Surgery Center, Istanbul, Turkey
(Sahin) Department of Radiology, Dr. Siyami Ersek Thoracic and
Cardiovascular Surgery Center, Istanbul, Turkey
Title
Computed tomography evaluation of different chest tube sites for residual
pleural volumes after coronary artery bypass surgery.
Source
Annals of Saudi Medicine. 31 (4) (pp 383-386), 2011. Date of
Publication: July-August 2011.
Publisher
Medknow Publications and Media Pvt. Ltd (B9, Kanara Business Centre, off
Link Road, Ghatkopar (E), Mumbai 400 075, India)
Abstract
Background and Objectives: We investigated the efficacy of pleural
drainage with the use of different chest tube methods in patients after
coronary artery bypass graft (CABG) surgery. Design and Setting:
Prospective randomized study of 60 patients undergoing elective on-pump
single CABG surgery. Patients and Methods: The left internal mammary
arterial grafts were harvested from all patients. The patients were
separated into three groups: In one group (IC6, n=20), pleural tubes were
inserted through the sixth intercostal space at the midaxillary line; in
the second group (SX-r, n=20), rigid straight pleural tubes were inserted
from the mediastinum through the subxiphoid area; and in the third group
(SX-s, n=20), soft curved drainage tubes were inserted from the
mediastinum through the subxiphoid area. The residual pleural effusion was
examined by multislice CT scans within 8 hours of removal of the drainage
tubes. Pain was evaluated according to standard methods. Results: The
groups did not differ with respect to volume of residual pleural effusion
(P >.05). The IC6 group had a higher mean pain score than the other two
groups (P <.05), whose mean pain scores did not differ significantly from
each other (P >.05). IC6 group patients had a higher requirement for
analgesics. The rate of atelectasis was higher in group IC6 (P <.05).
Conclusion: CT scans revealed that different chest tube insertion sites
have the same efficiency for draining of pleural effusion, although
drainage tubes inserted through the thoracic cage may result in more
severe pain.

<8>
Accession Number
2011419011
Authors
Aykut K. Celik B. Ackel U.
Institution
(Aykut, Celik, Ackel) Department of Cardiothoracic Surgery, Ozel Ege
Hospital, Denizli, Turkey
Title
Figure-of-eight versus prophylactic sternal weave closure of median
sternotomy in diabetic obese patients undergoing coronary artery bypass
grafting.
Source
Annals of Thoracic Surgery. 92 (2) (pp 638-641), 2011. Date of
Publication: August 2011.
Publisher
Elsevier USA (6277 Sea Harbor Drive, Orlando FL 32862 8239, United States)
Abstract
Background: Sternal dehiscence is a serious and potentially devastating
complication after median sternotomy, especially in diabetic obese
patients. The optimal technique for sternal closure is unclear in these
patients. Methods: The purpose of this prospective randomized study was to
compare the incidence of sternal dehiscence after prophylactic sternal
weave and figure-of-eight suturing in diabetic obese patients undergoing
coronary artery bypass grafting (CABG). The patients were randomly
assigned to group A (figure-of-eight closure; n = 75) or group B (sternal
weave closure; n = 75). Results: There were 8 cases of sternal dehiscence
documented: 7 in group A and 1 in group B. In group A, 5 patients had
noninfectious sternal dehiscence and 2 patients underwent reoperation
because of sternal dehiscence with mediastinitis. Also, 1 of the
noninfected patients had deep-seated pain with a feeling of bony crepitus
and needed reoperation. The other 4 patients in group A and 1 patient with
noninfectious sternal dehiscence in group B were given chest binder
support. Pain and bony crepitus decreased in the follow-up period of 1
year. Sternal dehiscence rates were 9.3% in group A and 1.3% in group B.
Sternal dehiscence was significantly lower in group B (p < 0.05).
Conclusions: Prophylactic sternal weave closure of median sternotomy
reduces morbidity from sternal dehiscence in diabetic obese patients
undergoing CABG. 2011 The Society of Thoracic Surgeons.

<9>
Accession Number
2011407081
Authors
Khan A. Agarwal R.
Institution
(Khan, Agarwal) Department of Pulmonary Medicine, Postgraduate Institute
of Medical Education and Research, Chandigarh, India
Title
Pulmonary alveolar proteinosis.
Source
Respiratory Care. 56 (7) (pp 1016-1028), 2011. Date of Publication: July
2011.
Publisher
Daedalus Enterprises Inc. (9425 North MacArthur Blvd, Suite 100, Irving TX
75063, United States)
Abstract
Pulmonary alveolar proteinosis is a rare but potentially treatable
disease, characterized by impaired surfactant metabolism that leads to
accumulation in the alveoli of proteinaceous material rich in surfactant
protein and its component. Novel insights from an animal model aided the
discovery of granulocyte macrophage colony stimulating factor (GM-CSF)
antibodies as a pathogenetic mechanism in human pulmonary alveolar
proteinosis. The vast majority of pulmonary alveolar proteinosis occurs as
an autoimmune disease; less commonly, it is congenital or secondary to an
underlying disorder such as infection, hematological malignancy, or
immunodeficiency. The subacute indolent course of this disease often
delays the diagnosis by months to years. Crazy-paving appearance in a
geographic distribution is a characteristic feature of this disease
visible on highresolution computed tomography (CT). A definitive
diagnosis, however, requires lung biopsy, which typically shows partial or
complete filling of alveoli with periodic-acid-Schiff-positive granular
and eosinophilic material in preserved alveolar architecture. Patients
with minimal symptoms are managed conservatively, whereas patients with
hypoxemia require a more aggressive approach. Wholelung lavage is the most
widely accepted therapy for symptomatic pulmonary alveolar proteinosis.
Correction of GM-CSF deficiency with exogenous GM-CSF is an alternative
therapy. The combination of a systemic treatment (GM-CSF) and a local
treatment (whole-lung lavage) augmenting the action of one another is a
promising new approach. As the knowledge about this rare disease
increases, the role of novel therapies is likely to be better defined and
optimized. 2011 Daedalus Enterprises.

<10>
Accession Number
21714415
Authors
Markar S.R. Sadat U. Edmonds L. Nair S.K.
Institution
(Markar) Department of Cardiothoracic Surgery, Papworth Hospital,
Cambridge, UK.
Title
Mitral valve repair versus replacement in the elderly population.
Source
The Journal of heart valve disease. 20 (3) (pp 265-271), 2011. Date of
Publication: May 2011.
Abstract
The study aim was to evaluate the available literature comparing mitral
valve repair (MVRep) versus mitral valve replacement (MVR) in the elderly
population, and to provide a pooled analysis regarding this issue.
Medline, Embase, Cochrane, trial registries, conference proceedings and
reference lists were searched for trials of MVRep versus MVR surgery in
the elderly population. The primary outcome was 30-day mortality, while
secondary outcomes were postoperative complications and length of hospital
stay. Pooled odds ratios were calculated for categorical outcomes and
weighted mean differences for continuous outcomes. Four studies retrieved
were deemed appropriate for inclusion. The outcome measures used for the
analysis clearly showed a benefit of MVRep in the elderly population with
reduced mortality (pooled Odds Ratio (OR) = 3.97; p = 0.003) and reduced
postoperative complications (pooled OR = 2.35; p = 0.003). There was no
significant difference between the two groups with regards to duration of
hospital stay (weighted mean difference = 0.22; p = 0.18). With the
demonstration of clear advantages of MVRep over MVR in the elderly
population, a randomized trial between the two techniques is not ethically
justifiable. As there are clear advantages to MVRep, it is recommended
that this should be the primary treatment offered in mitral valve
pathology, irrespective of the patient's age.

<11>
Accession Number
2011425981
Authors
Teng S. Kaufman J. Pan Z. Czaja A. Shockley H. Da Cruz E.
Institution
(Teng, Czaja) Division of Critical Care, Department of Pediatrics,
Children's Hospital, Aurora, CO, United States
(Kaufman, Shockley, Da Cruz) Division of Cardiology, Department of
Pediatrics, Children's Hospital, Aurora, CO, United States
(Pan) Research Institute, Department of Pediatrics, Children's Hospital,
Aurora, CO, United States
Title
Continuous arterial pressure waveform monitoring in pediatric cardiac
transplant, cardiomyopathy and pulmonary hypertension patients.
Source
Intensive Care Medicine. 37 (8) (pp 1297-1301), 2011. Date of
Publication: August 2011.
Publisher
Springer Verlag (Tiergartenstrasse 17, Heidelberg D-69121, Germany)
Abstract
Purpose: A continuous cardiac output monitor based on arterial pressure
waveform (FloTrac/Vigileo; Edwards Lifesciences, Irvine, CA) is now
approved for use in adults but not in children. This device is minimally
invasive, calculates cardiac output continuously and in real time, and is
easy to use. Our study sought to validate the FloTrac with the pulmonary
artery catheter (PAC) intermittent thermodilution technique in pediatric
cardiac patients. Methods: This was a prospective pilot study comparing
cardiac output measurements obtained via the FloTrac and arterial pressure
waveform analysis with intermittent thermodilution. Subjects carried the
diagnosis of pulmonary hypertension or cardiomyopathy, or were in the
postoperative course after orthotopic heart transplantation. Results:
Enrolled in the study were 31 subjects, and 136 data points were obtained.
The age range was 8 months to 16 years. The mean body surface area (BSA)
was 1.1 m². Bland-Altman plots for the mean cardiac outputs of
all subjects with a BSA >=1 m ² showed limits of agreement of
-2.7 to 8.0 l/min (+/-5.4 l/min). Patients with a BSA >=1 m²
demonstrated even wider limits of agreement (+/-8.5 l/min). The intraclass
correlation for the PAC was 0.929 and 0.992 for the FloTrac. Conclusion:
There was poor agreement between the PAC and FloTrac in measuring cardiac
output in a population of children with pulmonary hypertension or
cardiomyopathy, or after cardiac transplantation. This is in contrast to
adult studies published thus far. This suggests that the utility of the
FloTrac and measurements obtained from arterial pulse wave analysis in
children is uncertain at this time. 2011 Copyright jointly held by
Springer and ESICM.

<12>
Accession Number
2011422400
Authors
Rahnavardi M. Yan T.D. Bannon P.G. Wilson M.K.
Institution
(Rahnavardi, Yan, Bannon, Wilson) Department of Cardiothoracic Surgery,
University of Sydney, Royal Prince Alfred Hospital, Sydney, NSW, Australia
(Rahnavardi, Yan, Bannon, Wilson) The Baird Institute for Applied Heart,
Lung Surgical Research, Sydney, NSW, Australia
Title
Aortic valve-sparing operations in aortic root aneurysms: Remodeling or
reimplantation?.
Source
Interactive Cardiovascular and Thoracic Surgery. 13 (2) (pp 189-197),
2011. Date of Publication: August 2011.
Publisher
European Association for Cardio-Thoracis Surgery (3 Park Street, Windsor,
Berkshire SL4 1LU, United Kingdom)
Abstract
A best evidence topic was written according to a structured protocol. The
question addressed was whether the reimplantation (David) technique or the
remodeling (Yacoub) technique provides the optimum event free survival in
patients with an aortic root aneurysm suitable for an aortic valve-sparing
operation. In total, 392 papers were found using the reported search
criteria, of which 14 papers provided the best evidence to answer the
clinical question. A total of 1338 patients (Yacoub technique in 606 and
David technique in 732) from 13 centres were included. In most series,
cardiopulmonary bypass time and aortic cross-clamp time were longer for
the David technique compared to the Yacoub technique. Early mortality was
comparable between the two techniques (0-6.9% for the Yacoub technique and
0- 6% for the David technique). There is a tendency for a higher freedom
from significant long-term aortic insufficiency in the David group than
the Yacoub group, which does not necessarily result in a higher
reoperation rate in the Yacoub group. In the largest series reported,
freedom from a moderate-to-severe aortic insufficiency at 12 years was
82.6 +/- 6.2% in the Yacoub and 91.0 +/- 3.8% in the David group (P =
0.035). Freedom from reoperation at the same time point was 90.4 +/- 4.7%
in the Yacoub group and 97.4 +/- 2.2% in the David group (P = 0.09). In
another series, freedom from reoperation at a follow-up time of about four
years was 89 +/- 4% in the Yacoub group and 98 +/- 2% in the David group.
Although some authors merely preferred the Yacoub technique for a bicuspid
aortic valve, the accumulated evidence in the current review indicates
comparable results for both techniques in a bicuspid aortic valve. Current
evidence is in favour of the David rather than the Yacoub technique in
pathologies such as Marfan syndrome, acute type A aortic dissection, and
excessive annular dilatation that may impair aortic root integrity.
Careful selection of patients for each technique and successful
restoration of normal cusp geometry are the keys to success in aortic
valve-sparing operations. 2011 Published by European Association for
Cardio-Thoracic Surgery. All rights reserved.

<13>
Accession Number
2011422395
Authors
van Wingerden J.J. Lapid O. Boonstra P.W. de Mol B.A.J.M.
Institution
(van Wingerden, Lapid) Department of Plastic Surgery, Academic Medical
Center, University of Amsterdam, Amsterdam, Netherlands
(Boonstra) Department of Cardiothoracic Surgery, Medisch Centrum
Leeuwarden, Leeuwarden, Netherlands
(de Mol) Department of Cardiothoracic Surgery, Academic Medical Center,
University of Amsterdam, Amsterdam, Netherlands
Title
Muscle flaps or omental flap in the management of deep sternal wound
infection.
Source
Interactive Cardiovascular and Thoracic Surgery. 13 (2) (pp 179-187),
2011. Date of Publication: August 2011.
Publisher
European Association for Cardio-Thoracis Surgery (3 Park Street, Windsor,
Berkshire SL4 1LU, United Kingdom)
Abstract
The primary question addressed was whether muscle flaps (MFs) offer a
significant advantage over an omental flap (OF) in the management of deep
sternal wound infection (DSWI) following cardiovascular surgery in terms
of outcome (morbidity and mortality). Altogether, 333 citations (from
PubMed and EMBASE and using a manual search, without language restriction)
were identified using the reported strategy. Focusing on publications from
single institutions with experience with both types of flap in the
treatment of DSWI, 16 studies represented the best evidence on the topic.
The author, journal, date and country of publication, patient group
studied, study type, relevant outcomes, results and study weaknesses were
tabulated. These 16 observational studies covered 1046 patients, and all
reported mortality rates. Unadjusted data from five of six studies
investigating a possible association between mortality and flap type
suggested a higher mortality rate following reconstruction with MFs. A
meta-analysis of all six studies indicates a slight, but not significant,
survival advantage for reconstruction with an OF [overall relative risk
1.29 (95% confidence interval 0.58-2.88)]. Thirteen studies reported on
the number of individual postoperative complications for a total of 964
patients. Data, unadjusted for potentially confounding surgical factors,
on complications following flap closure, such as complete or partial flap
loss, haematoma, arm or shoulder weakness and chronic chest wall pain,
suggested that these complications were more common following MF
reconstruction. Four studies evaluated patients with recurrent sternal
wound infection (n = 521). Two of these were associated with a high
incidence (> 17.5%) of re-exploration for recurrent sternal infection
following MF reconstruction. The most commonly reported complications
following an OF were abdominal or diaphragmatic hernias, with an incidence
of < 5%. We conclude that the weight of current evidence is insufficient
to prove the superiority of reconstruction with MFs to a
laparotomy-harvested, OF in the treatment of DSWI. The results suggest
that use of the omentum may be associated with lower mortality and fewer
complications. 2011 Published by European Association for Cardio-Thoracic
Surgery. All rights reserved.

<14>
Accession Number
2011422394
Authors
McCormack A.C. Jarral O.A. Shipolini A.R. McCormack D.J.
Institution
(McCormack, Jarral, Shipolini, McCormack) Department of Cardiothoracic
Surgery, The London Chest Hospital, London, United Kingdom
Title
Does the nerve of Kuntz exist?.
Source
Interactive Cardiovascular and Thoracic Surgery. 13 (2) (pp 175-178),
2011. Date of Publication: August 2011.
Publisher
European Association for Cardio-Thoracis Surgery (3 Park Street, Windsor,
Berkshire SL4 1LU, United Kingdom)
Abstract
A best evidence topic was written according to a structured protocol. The
question addressed was, in what proportion of patients is the nerve of
Kuntz identifiable? A total of 55 papers were found using the reported
search, of which six represented the best evidence to answer the clinical
question. The authors, date, journal, study type, population, main outcome
measures and results are tabulated. The nerve of Kuntz was originally
described in 1927 as being a connection from the second intercostal nerve
to the first thoracic ventral ramus. Controversy exists as to whether it
is present universally and thus whether it should be identified during
thoracoscopic sympathectomy. The six studies highlighted involved
dissection of the upper thoracic sympathetic chain of adult cadavers with
descriptions of the anatomical variations. A study by Cho et al. [Cho HM,
Lee DY, Sung SW. Anatomical variations of rami communicants in the upper
thoracic sympathetic trunk. Eur J Cardiothorac Surg 2005;27:320-324]
suggested that anatomical variation was more common at T2 compared to T3
and T4, of which 60% corresponded to the original description of the nerve
of Kuntz. A similar prevalence was found by Marhold and colleagues
[Marhold F, Izay B, Zacherl J, Tschabitscher M, Neumayer C. Thoracoscopic
and anatomic landmarks of Kuntz's nerve: implications for sympathetic
surgery. Ann Thorac Surg 2008;86:1653-1658], who also suggested that open
dissection led to significantly easier identification of this anatomy than
thoracoscopy. The same authors frequently found that the nerve of Kuntz
was associated with a superior intercostal vein located parallel to it,
meaning that these subpleural veins may act as an anatomical landmark. In
four of the papers where cadavers where dissected bilaterally, variations
in the anatomy of the sympathetic chain were not always symmetrical. We
conclude that most patients will have some form of variation in the
anatomy of their T2 ganglion, which often corresponds to the original
description of the nerve of Kuntz. The appreciation of this variation may
be more difficult during thoracoscopy as compared to open anatomic
dissection. 2011 Published by European Association for Cardio-Thoracic
Surgery. All rights reserved.

<15>
Accession Number
2011422393
Authors
Haghshenasskashani A. Rahnavardi M. Yan T.D. Mccaughan B.C.
Institution
(Haghshenasskashani, Rahnavardi, Yan, Mccaughan) Department of
Cardiothoracic Surgery, The University of Sydney, Royal Prince Alfred
Hospital, Sydney, Australia
(Haghshenasskashani, Rahnavardi, Yan, Mccaughan) The Baird Institute for
Applied Heart, Lung Surgical Research, Sydney, Australia
Title
Intrathoracic application of a vacuum-assisted closure device in managing
pleural space infection after lung resection: Is it an option?.
Source
Interactive Cardiovascular and Thoracic Surgery. 13 (2) (pp 168-174),
2011. Date of Publication: August 2011.
Publisher
European Association for Cardio-Thoracis Surgery (3 Park Street, Windsor,
Berkshire SL4 1LU, United Kingdom)
Abstract
Empyema after lung resection is a challenging condition to manage and is
associated with a high mortality. Intrathoracic application of a
vacuum-assisted closure (VAC) device is recently introduced as an adjunct
in the management of this condition. A best evidence topic was constructed
to address whether this approach is effective in successful chest closure
and reducing hospital stay. Twenty-three papers were found using the
reported search, of which nine papers were identified that provided the
best evidence to answer the question. All papers were retrospective and
included a total of 69 patients treated with intrathoracic VAC. There was
only one cohort study and the rest were either case series or case
reports. In a cohort of 19 patients reported by Palmen et al. the average
duration of an open window thoracostomy in a group of patients with VAC (n
= 11) was 39 +/- 17 days and in those without VAC (n = 8) was 933 +/- 1422
days. Median length of VAC treatment was 22 days (range 6-66 days) in a
series of 28 patients reported by Saadi et al. Some authors excluded
patients with a bronchopleural fistula (BPF) from VAC treatment. However,
Groetzner et al. have safely used VAC in patients with BPF after covering
the bronchus stump with an intrathoracic muscle flap. The mediastinum and
the bronchus can be covered using a polyvinyl-alcohol foam. Polyurethane
foam is commonly used to fill the intrathoracic cavity up to the
superficial wound. The suggested starting level of negative pressure is as
low as -25 mmHg to -75 mmHg depending on the presence or absence of signs
of mediastinal traction; this negative pressure can gradually be increased
to -125 mmHg over time. The recommended interval between VAC changes is
two to five days. Accumulated evidence in this article, although limited,
suggests that VAC, as an adjunct to the standard treatment, can
potentially alleviate the morbidity and decrease hospital stay in patients
with empyema after lung resection. VAC can reduce inpatient length of
treatment and can make the condition manageable in an outpatient setting.
These results are yet to be proven by larger studies and clinical trials.
2011 Published by European Association for Cardio-Thoracic Surgery. All
rights reserved.

<16>
Accession Number
2011422392
Authors
Kung V.W.S. Jarral O.A. Shipolini A.R. McCormack D.J.
Institution
(Kung, Jarral, Shipolini, McCormack) Department of Cardiothoracic Surgery,
The London Chest Hospital, Bonner Road, London E2 9JX, United Kingdom
Title
Is it safe to perform coronary angiography during acute endocarditis?.
Source
Interactive Cardiovascular and Thoracic Surgery. 13 (2) (pp 158-167),
2011. Date of Publication: August 2011.
Publisher
European Association for Cardio-Thoracis Surgery (3 Park Street, Windsor,
Berkshire SL4 1LU, United Kingdom)
Abstract
A best evidence topic was written according to a structured protocol. The
question addressed was 'Is it safe to perform coronary angiography (CA) in
acute endocarditis?' Three hundred and ninety-seven papers were found
using the reported search, of which six represented the best evidence to
answer the clinical question. The authors, journal, date and country of
publication, patient group studied, study type, relevant outcomes, key
results and limitations of these papers are tabulated. One of the papers
is a case report, which reported a fatal vegetation embolism from an
infected aortic valve into the left main coronary artery 14 h after
angiography. The remaining five papers are cohort studies. Four of these
studies were performed between 1970 and 1980 before the era of
echocardiography and were aimed at quantifying the severity of valvular
regurgitation. No embolic complications or dislodgement of vegetations
occurred in any of the five studies (186 patients). Guidelines published
by the European Society of Cardiology (ESC) in 2009 recommended CA in the
context of infective endocarditis (IE) for men > 40 years old,
postmenopausal women, and patients with at least one cardiovascular risk
factor or a history of coronary artery disease. Exceptions include
patients with large aortic vegetations which may be dislodged during
catheterisation, and when emergency surgery is necessary - 1) native
aortic or mitral IE with severe acute regurgitation or valve obstruction,
or prosthetic valve IE with severe prosthetic dysfunction (dehiscence or
obstruction) causing refractory pulmonary oedema or cardiogenic shock; 2)
native aortic, mitral, or prosthetic valve IE with fistula into a cardiac
chamber or pericardium causing refractory pulmonary oedema or shock. This
is reiterated by the guidelines on the management of valvular heart
disease published by the ESC in 2007. From the findings of the six papers,
it can be concluded that coronary angiography can be performed safely in
IE and should be performed if deemed necessary, unless the patients are
haemodynamically unstable requiring emergency surgery, or have large
vegetations of the aortic valve. This is consistent with the ESC
guidelines. 2011 Published by European Association for Cardio-Thoracic
Surgery. All rights reserved.

<17>
Accession Number
2011422387
Authors
Koch A.M. Dittrich S. Cesnjevar R. Ruffer A. Breuer C. Glockler M.
Institution
(Koch, Dittrich, Breuer, Glockler) Department of Pediatric Cardiology,
University of Erlangen-Nurnberg, Loschgestrasse 15, D-91054 Erlangen,
Germany
(Cesnjevar, Ruffer) Department of Pediatric Cardiac Surgery, University of
Erlangen-Nurnberg, Loschgestrasse 15, D-91054 Erlangen, Germany
Title
Plasma neutrophil gelatinase-associated lipocalin measured in consecutive
patients after congenital heart surgery using point-of-care technology.
Source
Interactive Cardiovascular and Thoracic Surgery. 13 (2) (pp 133-136),
2011. Date of Publication: August 2011.
Publisher
European Association for Cardio-Thoracis Surgery (3 Park Street, Windsor,
Berkshire SL4 1LU, United Kingdom)
Abstract
Neutrophil gelatinase-associated lipocalin (NGAL) is an early predictive
biomarker of acute kidney injury. Plasma NGAL was measured in 218
consecutive patients aged three days to 21.1 years after admission to the
intensive care unit after cardiopulmonary bypass surgery using a
commercially available point-of-care test to evaluate its diagnostic value
in daily practice. Plasma NGAL was between 60 and 644 ng/ml in all
patients [median 134 (interquartile range 94-194) ng/ml]. In 31% of
patients, serum creatinine increased more than 50% within three days after
surgery, but no patient needed renal replacement therapy. In the early
neonatal period, NGAL was positively correlated to baseline serum
creatinine (r = 0.47; P = 0.02). In patients aged more than 10 days,
plasma NGAL was correlated to peak serum creatinine in the postoperative
course (r = 0.21; P = 0.003), and to the severity of acute kidney injury
(r = 0.15; P = 0.032). However, NGAL values were substantially scattered.
Plasma NGAL levels early after congenital heart surgery are correlated to
acute kidney injury, but the severity of kidney injury cannot be deduced
from an individual NGAL value. Therefore, the value of one single plasma
NGAL measurement performed early after cardiac bypass surgery for
congenital heart disease is limited. 2011 Published by European
Association for Cardio-Thoracic Surgery. All rights reserved.

<18>
Accession Number
2011422384
Authors
Sundermann S. Dademasch A. Rastan A. Praetorius J. Rodriguez H. Walther T.
Mohr F.-W. Falk V.
Institution
(Sundermann, Rodriguez, Falk) Department of Cardiovascular Surgery,
University Hospital Zurich, Ramistrasse 100, 8091 Zurich, Switzerland
(Dademasch, Rastan, Praetorius, Mohr) Department of Cardiac Surgery, Heart
Center Leipzig, University Leipzig, Strumpellstr. 39, 04289 Leipzig,
Germany
(Walther) Department of Cardiac Surgery, Kerckhoff Klinik Bad Nauheim,
Benekestrasse 2-8, 61231 Bad Nauheim, Germany
Title
One-year follow-up of patients undergoing elective cardiac surgery
assessed with the comprehensive assessment of frailty test and its
simplified form.
Source
Interactive Cardiovascular and Thoracic Surgery. 13 (2) (pp 119-123),
2011. Date of Publication: August 2011.
Publisher
European Association for Cardio-Thoracis Surgery (3 Park Street, Windsor,
Berkshire SL4 1LU, United Kingdom)
Abstract
Assessment of perioperative risk of elderly patients in cardiac surgery is
demanding. Most of the commonly used cardiac surgery risk scores over-or
underestimate individual risk. Therefore, we recently developed a 'frailty
score', the comprehensive assessment of frailty (CAF) score that showed a
good prediction of 30-day mortality. The aim of the study was to evaluate
the ability of the new score predicting one-year outcome. CAF was
preoperatively applied to 400 patients >= 74 years that were admitted to
cardiac surgery between September 2008 and January 2010. For 213 of these
patients one-year follow-up was assessed by telephone interview until
April 2010. One hundred and ten male and 103 female patients were
included. Twenty-five percent underwent isolated coronary
revascularization, 35% isolated valve procedures and 26% underwent
combined procedures. One-year mortality was 12.2%. Patients who died
within one year had a median frailty score of 16 [5;33] compared to 11
[3;33] to the one-year survivors (P = 0.001). A new, easily applicable
score ('Frailty predicts death One yeaR after Elective Cardiac Surgery
Test') was built out of the basic score and showed a promising ability to
predict one-year mortality. CAF is a new additional tool to assess
prognosis of elderly patients before cardiac surgical interventions. The
'CAF' score facilitates prediction of mid-term outcome of high-risk
elderly patients. 2011 Published by European Association for
Cardio-Thoracic Surgery. All rights reserved.

<19>
Accession Number
2011419028
Authors
Mukherjee D. Rao C. Ibrahim M. Ahmed K. Ashrafian H. Protopapas A. Darzi
A. Athanasiou T.
Institution
(Mukherjee, Rao, Ibrahim, Ahmed, Ashrafian, Protopapas, Darzi, Athanasiou)
Department of Biosurgery and Surgical Technology, Imperial College London,
London, United Kingdom
Title
Meta-analysis of organ damage after conversion from off-pump coronary
artery bypass procedures.
Source
Annals of Thoracic Surgery. 92 (2) (pp 755-761), 2011. Date of
Publication: August 2011.
Publisher
Elsevier USA (6277 Sea Harbor Drive, Orlando FL 32862 8239, United States)
Abstract
The relative efficacy of off-pump and on-pump coronary revascularization
is uncertain. A complication of off-pump surgery which is rarely
considered is intraoperative conversion to cardiopulmonary bypass.
Consequently, meta-analysis was performed of studies comparing morbidity
after converted and nonconverted off-pump coronary revascularization.
There were significant increases in the likelihood of stroke, myocardial
injury, bleeding, renal failure, wound infection, intraaortic balloon pump
requirement, transfusion, and respiratory and gastrointestinal
complications after conversion. The underlying mechanisms need to be
urgently elucidated. Prevention and treatment protocols for conversion
warrant serious consideration and the risk of conversion may need to be
discussed when obtaining informed patient consent. 2011 The Society of
Thoracic Surgeons.

<20>
Accession Number
2011418994
Authors
Von Eckardstein A.S. Lim C.H. Dohmen P.M. Pego-Fernandes P.M. Cooper W.A.
Oslund S.G. Kelley E.L.
Institution
(Von Eckardstein, Lim, Dohmen, Pego-Fernandes, Cooper, Oslund, Kelley)
Hospital Dr. Hernan Henriquez Aravena, Manuel Montt 115, Temuco, Chile
(Von Eckardstein, Lim, Dohmen, Pego-Fernandes, Cooper, Oslund, Kelley)
National Heart Centre, Mistri Wing, Singapore, Singapore
(Von Eckardstein, Lim, Dohmen, Pego-Fernandes, Cooper, Oslund, Kelley)
Department of Cardiovascular Surgery, Charite Hospital, Medical University
Berlin, Berlin, Germany
(Von Eckardstein, Lim, Dohmen, Pego-Fernandes, Cooper, Oslund, Kelley)
Department of Cardiovascular Surgery, Hospital das Clinicas, Universidade
de Sao Paulo, Sao Paulo, Brazil
(Von Eckardstein, Lim, Dohmen, Pego-Fernandes, Cooper, Oslund, Kelley)
Emory Clinic at WellStar Kennestone Hospital, Marietta, GA, United States
(Von Eckardstein, Lim, Dohmen, Pego-Fernandes, Cooper, Oslund, Kelley)
Kimberly-Clark Health Care, Roswell, GA, United States
Title
A randomized trial of a skin sealant to reduce the risk of incision
contamination in cardiac surgery.
Source
Annals of Thoracic Surgery. 92 (2) (pp 632-637), 2011. Date of
Publication: August 2011.
Publisher
Elsevier USA (6277 Sea Harbor Drive, Orlando FL 32862 8239, United States)
Abstract
Background: Immobilizing skin microbes is a rational approach to reducing
contamination of surgical sites by endogenous microorganisms. Methods:
This randomized, controlled, parallel-group, multicenter, open-label
clinical trial (ClinicalTrials.gov NCT00467857) enrolled 300 adults
scheduled for elective coronary artery bypass graft surgery. Patients
received iodine-based skin preparations followed by a cyanoacrylate-based
skin sealant or skin preparations alone. Microbiological samples collected
from sternal and graft incision sites immediately before any skin
preparation, at the wound border after skin incision, and at the incision
after fascial closure were evaluated quantitatively. Results: In evaluable
patients, mean microbial counts in collected samples increased at the
sternal site after fascial closure compared with after skin incision by
0.37 log₁₀ colony-forming units (CFU)/mL in the skin sealant
group (n = 120) and by 0.57 log₁₀ CFU/mL in the control group
(n = 132) (p = 0.047, Wilcoxon rank sum test). At the graft site, mean
microbial counts increased by 0.09 (n = 119) and 0.27 (n = 127) log
₁₀ CFU/mL, respectively (p = 0.037). There was a 35.3% relative
risk reduction in surgical site infection (SSI) occurring in the skin
sealant group (9 of 146 patients, 6.2%) versus the control group (14 of
147 patients, 9.5%). In obese patients (body mass index [BMI] > 30.0 to <=
37.0 kg/m ²), the relative risk reduction for SSI associated
with skin sealant was 83.3%. Conclusions: Pretreatment with skin sealant
protects against contamination of the surgical incision by migration of
skin microbes. Further data are needed to confirm the impact of this
technology on SSI rates in clinical practice. 2011 The Society of
Thoracic Surgeons.

<21>
Accession Number
21463531
Authors
Haykowsky M. Scott J. Esch B. Schopflocher D. Myers J. Paterson I.
Warburton D. Jones L. Clark A.M.
Institution
(Haykowsky) University of Alberta, Edmonton, Canada.
Title
A meta-analysis of the effects of exercise training on left ventricular
remodeling following myocardial infarction: start early and go longer for
greatest exercise benefits on remodeling.
Source
Trials. 12 (pp 92), 2011. Date of Publication: 2011.
Abstract
The effects of variations in exercise training on left ventricular (LV)
remodeling in patients shortly after myocardial infarction (MI) are
important but poorly understood. Systematic review incorporating
meta-analysis using meta-regression. Studies were identified via
systematic searches of: OVID MEDLINE (1950 to 2009), Cochrane Central
Register of Controlled Trials (1991 to 2009), AMED (1985 to 2009), EMBASE
(1988 to 2009), PUBMED (1966 to 2009), SPORT DISCUS (1975 to 2009), SCOPUS
(1950 to 2009) and WEB OF SCIENCE (1950 to 2009) using the medical subject
headings: myocardial infarction, post myocardial infarction, post
infarction, heart attack, ventricular remodeling, ventricular volumes,
ejection fraction, left ventricular function, exercise, exercise therapy,
kinesiotherapy, exercise training. Reference lists of all identified
studies were also manually searched for further relevant studies. Studies
selected were randomized controlled trials of exercise training
interventions reporting ejection fraction (EF) and/or ventricular volumes
in patients following recent MI (<= 3 months) post-MI patients involving
control groups. Studies were excluded if they were not randomized, did not
have a 'usual-care' control (involving no exercise), evaluated a
non-exercise intervention, or did not involve human subjects. Non-English
studies were also excluded. After screening of 1029 trials, trials were
identified that reported EF (12 trials, n = 647), End Systolic Volumes
(ESV) (9 trials, n = 475) and End Diastolic Volumes (EDV) (10 trials, n =
512). Meta-regression identified that changes in EF effect size difference
decreased as the time between MI and initiation of the exercise program
lengthened, and increased as the duration of the program increased (Q =
25.48, df = 2, p < 0.01, R2 = 0.76). Greater reductions in ESV and EDV (as
indicated by effect size decreases) occurred with earlier initiation of
exercise training and with longer training durations (ESV: Q = 23.89, df =
2, p < 0.05, R2 = 0.79; EDV: Q = 27.42, df = 2, p < 0.01, R2 = 0.83).
Differences remained following sensitivity analysis. Each week that
exercise was delayed required an additional month of training to achieve
the same level of benefit on LV remodeling. Exercise training has
beneficial effects on LV remodeling in clinically stable post-MI patients
with greatest benefits occurring when training starts earlier following MI
(from one week) and lasts longer than 3 months.

<22>
[Use Link to view the full text]
Accession Number
2011424626
Authors
Antoniades C. Bakogiannis C. Leeson P. Guzik T.J. Zhang M.-H. Tousoulis D.
Antonopoulos A.S. Demosthenous M. Marinou K. Hale A. Paschalis A. Psarros
C. Triantafyllou C. Bendall J. Casadei B. Stefanadis C. Channon K.M.
Institution
(Antoniades, Leeson, Zhang, Hale, Bendall, Casadei, Channon) Department of
Cardiovascular Medicine, University of Oxford, John Radcliffe Hospital,
OX3 9DU Oxford, United Kingdom
(Antoniades, Bakogiannis, Tousoulis, Antonopoulos, Demosthenous, Marinou,
Paschalis, Psarros, Stefanadis) First Department of Cardiology, University
of Athens, Hippokration Hospital, Athens, Greece
(Guzik, Paschalis) Department of Medicine, Jagiellonian University,
Krakow, Poland
(Paschalis, Triantafyllou) Department of Cardiac Surgery, Hippokration
Hospital, Athens, Greece
Title
Rapid, direct effects of statin treatment on arterial redox state and
nitric oxide bioavailability in human atherosclerosis via
tetrahydrobiopterin- mediated endothelial nitric oxide synthase coupling.
Source
Circulation. 124 (3) (pp 335-345), 2011. Date of Publication: 19 Jul
2011.
Publisher
Lippincott Williams and Wilkins (530 Walnut Street,P O Box 327,
Philadelphia PA 19106-3621, United States)
Abstract
Background-: Treatment with statins improves clinical outcome, but the
exact mechanisms of pleiotropic statin effects on vascular function in
human atherosclerosis remain unclear. We examined the direct effects of
atorvastatin on tetrahydrobiopterin-mediated endothelial nitric oxide (NO)
synthase coupling in patients with coronary artery disease. Methods and
Results-: We first examined the association of statin treatment with
vascular NO bioavailability and arterial superoxide
(O₂^.-) in 492 patients undergoing coronary artery
bypass graft surgery. Then, 42 statin-naive patients undergoing elective
coronary artery bypass graft surgery were randomized to atorvastatin 40
mg/d or placebo for 3 days before surgery to examine the impact of
atorvastatin on endothelial function and O₂^.-
generation in internal mammary arteries. Finally, segments of internal
mammary arteries from 26 patients were used in ex vivo experiments to
evaluate the statin-dependent mechanisms regulating the vascular redox
state. Statin treatment was associated with improved vascular NO
bioavailability and reduced O₂^.- generation in
internal mammary arteries. Oral atorvastatin increased vascular
tetrahydrobiopterin bioavailability and reduced basal and
N-nitro-L-arginine methyl ester-inhibitable O₂^.- in
internal mammary arteries independently of low-density lipoprotein
lowering. In ex vivo experiments, atorvastatin rapidly improved vascular
tetrahydrobiopterin bioavailability by upregulating GTP-cyclohydrolase I
gene expression and activity, resulting in improved endothelial NO
synthase coupling and reduced vascular O₂^.-. These
effects were reversed by mevalonate, indicating a direct effect of
vascular hydroxymethylglutaryl- coenzyme A reductase inhibition.
Conclusions-: This study demonstrates for the first time in humans the
direct effects of statin treatment on the vascular wall, supporting the
notion that this effect is independent of low-density lipoprotein
lowering. Atorvastatin directly improves vascular NO bioavailability and
reduces vascular O₂^.- through tetrahydrobiopterin-
mediated endothelial NO synthase coupling. These findings provide new
insights into the mechanisms mediating the beneficial vascular effects of
statins in humans. Clinical Trial Registration-: URL:
http://www.clinicaltrials.gov. Unique identifier: NCT01013103. 2011
American Heart Association, Inc.

<23>
[Use Link to view the full text]
Accession Number
2011424623
Authors
Jessup M. Greenberg B. Mancini D. Cappola T. Pauly D.F. Jaski B.
Yaroshinsky A. Zsebo K.M. Dittrich H. Hajjar R.J.
Institution
(Jessup, Cappola) Heart Failure/Transplant Program, Hospital of the
University of Pennsylvania, 2 e Perelman Pavilion, 3400 Civic Center Blvd,
Philadelphia, PA 19104, United States
(Greenberg, Dittrich) University of California-San Diego, Medical Center,
United States
(Mancini) New York-Presbyterian Hospital, Columbia University Hospital,
New York, NY, United States
(Pauly) Shands Hospital, University of Florida, Gainesville, United States
(Jaski) San Diego Cardiac Center, San Diego, CA, United States
(Yaroshinsky, Zsebo) Celladon Corporation, San Diego, CA, United States
(Hajjar) Mt Sinai School of Medicine, New York, NY, United States
Title
Calcium upregulation by percutaneous administration of gene therapy in
cardiac disease (CUPID): A phase 2 trial of intracoronary gene therapy of
sarcoplasmic reticulum Ca2+-ATPase in patients with advanced heart
failure.
Source
Circulation. 124 (3) (pp 304-313), 2011. Date of Publication: 19 Jul
2011.
Publisher
Lippincott Williams and Wilkins (530 Walnut Street,P O Box 327,
Philadelphia PA 19106-3621, United States)
Abstract
Background-: Adeno-associated virus type 1/sarcoplasmic reticulum Ca
²⁺-ATPase was assessed in a randomized, double-blind,
placebo-controlled, phase 2 study in patients with advanced heart failure.
Methods and Results-: Thirty-nine patients received intracoronary
adeno-associated virus type 1/sarcoplasmic reticulum
Ca²⁺-ATPase or placebo. Seven efficacy parameters were assessed
in 4 domains: symptoms (New York Heart Association class, Minnesota Living
With Heart Failure Questionnaire), functional status (6-minute walk test,
peak maximum oxygen consumption), biomarker (N-terminal prohormone brain
natriuretic peptide), and left ventricular function/remodeling (left
ventricular ejection fraction, left ventricular end-systolic volume), plus
clinical outcomes. The primary end point success criteria were
prospectively defined as achieving efficacy at 6 months in the group-level
(concordant improvement in 7 efficacy parameters and no clinically
significant worsening in any parameter), individual-level (total score for
predefined clinically meaningful changes in 7 efficacy parameters), or
outcome end points (cardiovascular hospitalizations and time to terminal
events). Efficacy in 1 analysis had to be associated with at least a
positive trend in the other 2 analyses. This combination of requirements
resulted in a probability of success by chance alone of 2.7%. The
high-dose group versus placebo met the prespecified criteria for success
at the group-level, individual-level, and outcome analyses (cardiovascular
hospitalizations) at 6 months (confirmed at 12 months) and demonstrated
improvement or stabilization in New York Heart Association class,
Minnesota Living With Heart Failure Questionnaire, 6-minute walk test,
peak maximum oxygen consumption, N-terminal prohormone brain natriuretic
peptide levels, and left ventricular end-systolic volume. Significant
increases in time to clinical events and decreased frequency of
cardiovascular events were observed at 12 months (hazard ratio=0.12;
P=0.003), and mean duration of cardiovascular hospitalizations over 12
months was substantially decreased (0.4 versus 4.5 days; P=0.05) on
high-dose treatment versus placebo. There were no untoward safety
findings. Conclusions-: The Calcium Upregulation by Percutaneous
Administration of Gene Therapy in Cardiac Disease (CUPID) study
demonstrated safety and suggested benefit of adeno-associated virus type
1/sarcoplasmic reticulum Ca²⁺-ATPase in advanced heart failure,
supporting larger confirmatory trials. CLINICAL TRIAL REGISTRATION-:
http://www.clinicaltrials.gov. Unique identifier: NCT00454818. 2011
American Heart Association, Inc.

<24>
Accession Number
2011416399
Authors
Bogaty P. Filion K.B. Brophy J.M.
Institution
(Bogaty) Institut universitaire de cardiologie et pneumologie de Quebec,
Quebec, Canada
(Filion) Division of Epidemiology and Community Health School of Public
Health University of Minnesota, Minneapolis, MN, United States
(Brophy) McGill University Health Center, McGill University, Montreal, QC,
Canada
Title
Routine invasive management after fibrinolysis in patients with
ST-elevation myocardial infarction: A systematic review of randomized
clinical trials.
Source
BMC Cardiovascular Disorders. 11 , 2011. Article Number: 34. Date of
Publication: 20 Jun 2011.
Publisher
BioMed Central Ltd. (34 - 42 Cleveland Street, London W1T 4LB, United
Kingdom)
Abstract
Background: Patients with ST-elevation myocardial infarction (STEMI)
treated with fibrinolysis are increasingly, and ever earlier, referred for
routine coronary angiography and where feasible, undergo percutaneous
coronary intervention (PCI). We sought to examine the randomized clinical
trials (RCTs) on which this approach is based.Methods: We systematically
searched EMBASE, Medline, and references of relevant studies. All
contemporary RCTs (published since 1995) that compared systematic invasive
management of STEMI patients after fibrinolysis with standard care were
included. Relevant study design and clinical outcome data were
extracted.Results: Nine RCTs that randomized a total of 3320 patients were
identified. All suggested a benefit from routine early invasive
management. They were individually reviewed but important design
variations precluded a formal quantitative meta-analysis. Importantly,
several trials did not compare a routine practice of invasive management
after fibrinolysis with a more selective 'ischemia-guided' approach but
rather compared an early versus later routine invasive strategy. In the
other studies, recourse to subsequent invasive management in the usual
care group varied widely. Comparison of the effectiveness of a routine
invasive approach to usual care was also limited by asymmetric use of a
second anti-platelet agent, differing enzyme definitions of reinfarction
occurring spontaneously versus as a complication of PCI, a preponderance
of the 'soft' outcome of recurrent ischemia in the combined primary
endpoint, and an interpretative bias when invasive procedures on follow-up
were tallied as an endpoint without considering initial invasive
procedures performed in the routine invasive arm.Conclusions: Due to
important methodological limitations, definitive RCT evidence in favor of
routine invasive management following fibrinolysis in patients with STEMI
is presently lacking. 2011 Bogaty et al; licensee BioMed Central Ltd.

<25>
Accession Number
2011416633
Authors
Das R. Ahmed K. Athanasiou T. Morgan R.A. Belli A.-M.
Institution
(Das, Morgan, Belli) Department of Radiology, St. George's Hospital,
Blackshaw Road, London SW17 0QT, United Kingdom
(Ahmed, Athanasiou) Department of Surgery and Cancer, Imperial College,
Praed Street, London W2 1NY, United Kingdom
Title
Arterial closure devices versus manual compression for femoral haemostasis
in interventional radiological procedures: A systematic review and
meta-analysis.
Source
CardioVascular and Interventional Radiology. 34 (4) (pp 723-738), 2011.
Date of Publication: August 2011.
Publisher
Springer New York (233 Springer Street, New York NY 10013-1578, United
States)
Abstract
Purpose: The use of arterial closure devices (ACDs) in interventional
radiology (IR) procedures has not yet been validated by large-scale
randomised controlled trials or meta-analysis. Improved haemostasis and
early mobilisation are publicised advantages; however, anecdotal evidence
of haemorrhagic and ischaemic complications with ACDs is also apparent.
Meta-analysis from interventional cardiology cannot be directly
extrapolated for IR patients. Materials and Methods: Systematic review,
performed according to Preferred Reporting Items for Systematic Reviews
and Meta-Analysis guidelines was performed to assess four ACDs: Angioseal;
StarClose; Perclose; and Duett - in peripheral vascular interventions:
uterine artery embolisation, transhepatic chemoembolisation, and cerebral
diagnostic and interventional procedures. Procedures requiring cardiac,
aortic, or nonfemoral access, as well as those requiring >8F sheath size,
were excluded. The outcomes assessed were device deployment failure,
haematoma, bleeding, groin pain, retroperitoneal haematoma, arteriovenous
fistula, infection, distal ischaemia, need for vascular surgery, need for
manual compression, and death. Results: Search of MEDLINE and other major
databases identified 34 studies from 15,805 records. Twenty-one
noncomparative studies (3,662 participants) demonstrated total
complication rates of 3.1-11.4%. Thirteen comparative studies were
analysed separately, and random-effects meta-analysis yielded 10 studies
(2,373 participants). Conclusion: Meta-analyses demonstrated no
statistically significant difference, but there were marginally fewer
complications with pooled ACDs compared with manual compression (odds
ratio [OR] 0.87, 95% confidence interval [CI] 0.52-1.48, p = 0.13). The
Angioseal group compared with the manual-compression group (total
complication rate: OR 0.84, 95% CI 0.53-1.34, p = 0.49) and the Perclose
group compared with the manual-compression group (total complication rate:
OR 1.29, 95% CI 0.19-8.96, p = 0.01) each demonstrated trends for and
against the specified ACD, respectively. Adequately powered randomised
controlled trials are required to further elucidate the efficacy of ACDs.
2010 Springer Science+Business Media, LLC and the Cardiovascular and
Interventional Radiological Society of Europe (CIRSE).

<26>
Accession Number
70499722
Authors
Edelman J. Yan T. Wilson M. Bannon P. Vallely M.
Institution
(Edelman, Yan, Wilson, Bannon, Vallely) Baird Institute, University of
Sydney, Royal Prince Alfred Hospital, Australia
Title
Radial artery versus saphenous vein as the second conduit in coronary
artery bypass grafting-a metaanalysis of clinical outcomes.
Source
Heart Lung and Circulation. Conference: Cardiac Society of Australia and
New Zealand Annual Scientific Meeting and the International Society for
Heart Research Australasian Section Annual Scientific Meeting 2011 Perth,
WA Australia. Conference Start: 20110811 Conference End: 20110814.
Conference Publication: (var.pagings). 20 (pp S227), 2011. Date of
Publication: 2011.
Publisher
Elsevier BV
Abstract
Background: The superiority of grafting the left internal mammary artery
(LIMA) to left anterior descending artery (LAD) iswell
established.However, the choice of the second best conduit remains less
clear. Many trials have collectively compared the right internal mammary
artery, radial artery, gastroepiploic artery and saphenous vein - most are
retrospective and fail to adequately address the specific question of the
second best conduit. Methods: We have performed a meta-analysis of trials
comparing the outcomes of patients receiving a radial artery (RA) or
saphenous vein (SV) graft to the best target after grafting the LIMA to
LAD. We assessed early (<1 y) and late survival (>1 y) as the primary
outcome. Results: Eight trials (three randomised, five observational) were
identified and compared 2980 patients with LIMA/radial artery grafting
with 6158 patients with LIMA/SV grafting. The mean follow-up of trials
included in the late follow-up analysis ranged from 5.7 to 7 years. There
was no significant difference in mortality early period (1.11% vs 1.67%,
RR 0.85, 95% confidence interval [CI] 0.53-1.38, p = 0.52). Mortalitywas
significantly lower in RA group for the late follow-up period (13.55% vs
28.46%, RR 0.63, CI 0.45-0.87, p = 0.005). Conclusion: The results of this
meta-analysis suggest that the RA may have a survival benefit over the SV
in the early and late post-operative period when grafted to the best
target after LIMA to LAD.

<27>
Accession Number
70499688
Authors
Mooney J. Ranasinghe I. Chow C. Barzi F. Zoungas S. Tan T. Perkovic V.
Hillis G.
Institution
(Mooney, Ranasinghe, Chow, Barzi, Zoungas, Perkovic, Hillis) George
Institute for Global Health, Sydney, Australia
(Chow, Tan) Westmead Hospital, Sydney, Australia
(Zoungas) Monash University, Melbourne, Australia
Title
Pre-operative kidney function as a predictor of adverse outcomes after
surgery- A systematic review and meta-analysis.
Source
Heart Lung and Circulation. Conference: Cardiac Society of Australia and
New Zealand Annual Scientific Meeting and the International Society for
Heart Research Australasian Section Annual Scientific Meeting 2011 Perth,
WA Australia. Conference Start: 20110811 Conference End: 20110814.
Conference Publication: (var.pagings). 20 (pp S212), 2011. Date of
Publication: 2011.
Publisher
Elsevier BV
Abstract
Background: Creatinine levels predict adverse outcomes after surgery but
are an imprecise measure of kidney function, and estimated glomerular
filtration rate (eGFR) could have greater predictive value. This study
assessed the strength of the relationship between eGFR and postoperative
outcomes. Method: A systematic review and meta-analysis were undertaken.
Cohort studieswere included if they reported the relationship between eGFR
and outcomes including major adverse cardiovascular events (MACE), acute
kidney injury (AKI) and all-cause mortality, in people having cardiac or
non-cardiac surgery. Results: Forty-seven studies enrolling 681,065
patients were included. An eGFR < 60 mL/min per 1.73m2 was associated with
an increased risk of all-cause mortality mortality (relative risk [RR]
3.50, 95% confidence interval [CI] 2.19-5.59) and AKI (RR 3.09, 95% CI
2.06-4.82) at short term follow up (in hospital or 30 days). At final
follow up, it was associated with an increased risk of MACE (RR 1.48 95%
CI 1.32-1.67) and all-cause mortality (RR 1.78 95% CI 1.50-2.08). There
was a significant inverse linear association between eGFR and risk. Each
10 mL/min per 1.73m2 lower eGFR was associated with an increased risk of
death (short-term RR 1.27 [1.23-1.31] and long-term 1.17 [1.12-1.22]).
Conclusion: Kidney function defined using eGFR demonstrates a powerful
inverse linear relationship to both short and long-term outcomes after
surgery. Further work is required to assess whether eGFR provides
prognostic information that improves existing risk prediction tools in
this setting.

<28>
Accession Number
70494346
Authors
Van Gestel A.J.R. Kohler M. Steier J. Teschler S. Russi E.W. Teschler H.
Institution
(Van Gestel, Kohler, Russi) University Hospital of Zurich, Zurich,
Switzerland
(Steier) Kings College London School of Medicine, London, United Kingdom
(Teschler, Teschler) University Hospital Ruhrlandklinik, Essen, Germany
Title
The effects of controlled breathing during pulmonary rehabilitation in
patients with COPD.
Source
Respiration. Conference: Joint Annual Meeting of the Swiss Respiratory
Society, Swiss Society of Oto-Rhino-Laryngology, Head and Neck Surgery,
Swiss Paediatric Respiratory Society, Swiss Society for Thoracic Surgery
2011 Interlaken Switzerland. Conference Start: 20110504 Conference End:
20110506. Conference Publication: (var.pagings). 82 (1) (pp 92-93),
2011. Date of Publication: June 2011.
Publisher
S. Karger AG
Abstract
Background: Conventional pulmonary rehabilitation programs improve
exercise tolerance but have no effect on pulmonary function in patients
with COPD. The role of controlled breathing using respiratory biofeedback
during rehabilitation of patients with COPD remains unclear. Objectives:
To compare the effects of a conventional 4-week pulmonary rehabilitation
program with those of rehabilitation plus controlled breathing
interventions. Methods: A randomized controlled trial was performed.
Pulmonary function (FEV1), exercise capacity (6-minute walking distance,
6MWD), health-related quality of life (chronic respiratory questionnaire,
CRQ) and cardiac autonomic function (rMSSD) were evaluated. Results: Forty
COPD patients (mean +/- SD age 66.1 +/- 6.4, FEV1 45.9 +/- 17.4
%predicted) were randomized to rehabilitation (n = 20) or rehabilitation
plus controlled breathing (n = 20). There were no statistically
significant differences between the two groups regarding the change in
FEV1 (mean difference -0.8 %predicted, 95% CI -4.4 to 2.9 %predicted, p =
0.33), 6MWD (mean difference 12.2 m, 95% CI -37.4 to 12.2 m, p = 0.16),
CRQ (mean difference in total score 0.2, 95% CI -0.1 to 0.4, p = 0.11) and
rMSSD (mean difference 2.2 ms, 95% CI -20.8 to 25.1 ms, p = 0.51).
Conclusions: In patients with COPD undergoing a pulmonary rehabilitation
program, controlled breathing using respiratory biofeedback has no effect
on exercise capacity, pulmonary function, quality of life or cardiac
autonomic function.

<29>
Accession Number
70494339
Authors
Stoewhas A.-C. Bloch K.E. Russi E.W. Stradling J.R. Kohler M.
Institution
(Stoewhas, Bloch, Russi, Kohler) University Hospital Zurich, Zurich,
Switzerland
(Stradling) Churchill Hospital, Oxford, United Kingdom
Title
CPAP therapy withdrawal - A model to evaluate treatments for obstructive
sleep apnoea.
Source
Respiration. Conference: Joint Annual Meeting of the Swiss Respiratory
Society, Swiss Society of Oto-Rhino-Laryngology, Head and Neck Surgery,
Swiss Paediatric Respiratory Society, Swiss Society for Thoracic Surgery
2011 Interlaken Switzerland. Conference Start: 20110504 Conference End:
20110506. Conference Publication: (var.pagings). 82 (1) (pp 88), 2011.
Date of Publication: June 2011.
Publisher
S. Karger AG
Abstract
Rationale: Evaluating new treatments for OSA recruiting previously
untreated patients in randomised controlled trials is time consuming and
expensive. A more efficient model to investigate OSA treatments could be
during withdrawal of CPAP. Objectives: To determine the effects of two
weeks CPAP withdrawal on sleep-disordered breathing, sleepiness and
psychomotor performance. Methods: 41 OSA patients on CPAP were randomized
to either withdraw CPAP (subtherapeutic-CPAP) or continue CPAP for 14
days. At baseline, 7 and 14 days, apnea/hypopnea index (AHI,1/h), oxygen
desaturation index (ODI,1/h), Epworth sleepiness scale (ESS), Osler test,
divided attention driving simulator (DADS) and psychomotor vigilance test
(PVT) were assessed. Measurements and main Results: Withdrawal of CPAP
increased AHI at 7 and 14 days (mean difference in AHI change +31.9 (95%CI
20.1,43.7) and +33.5 (95%CI 22.4/44.6), respectively) and ODI (mean
difference in ODI change +26.3 (95%CI 16.6,36.0) and +26.4 (95%CI
16.1,36.8), respectively) in comparison to continuation of CPAP (p < 0.001
for all comparisons). ESS increased significantly at 7 and 14 days in the
CPAP withdrawal group compared to the CPAP group (mean difference in ESS
change +1.9 (95%CI 0.4,3.3) and +2.7 (95%CI 1.2,4.3), p = 0.015 and p <
0.001, respectively). Withdrawal of CPAP was not associated with
deterioration in the Osler test, DADS and the PVT at 7 and 14 days.
Conclusions: CPAP withdrawal usually leads to a rapid recurrence of OSA
and a slow return of subjective sleepiness, but is not associated with
deterioration in psychomotor performance within 14 days. Therefore, this
model seems suitable and safe to evaluate treatment effects on OSA.

<30>
Accession Number
70492675
Authors
Brown S.
Institution
(Brown) Texas Health Presbyterian Hospital, United States
(Brown) Fitness Center, United States
Title
Implementation of a computerized, automated referral system in improving
participation rates to outpatient cardiac rehabilitation.
Source
Journal of Cardiopulmonary Rehabilitation and Prevention. Conference:
26th Annual Meeting of the American Association of Cardiovascular and
Pulmonary Rehabilitation Anaheim, CA United States. Conference Start:
20110908 Conference End: 20110910. Conference Publication: (var.pagings).
31 (4) (pp E2), 2011. Date of Publication: July-August 2011.
Publisher
Lippincott Williams and Wilkins
Abstract
Introduction: Despite American College of Cardiology and American Heart
Association performance measures which state that patients with a primary
diagnosis during hospitalization of chronic stable angina, MI, CABG, valve
surgery, or cardiac transplantation are to be referred to an outpatient
cardiac rehabilitation program, it has been well-established that both
referral and participation rates in Phase II Cardiac Rehabilitation after
hospitalization are low. To enhance participation to a broader population
of patients, an automated, computerized referral system was implemented in
a large, multi-hospital system. Purpose: To determine the efficacy of an
automated, computerized referral system as compared to a traditional,
non-automated referral strategy. Design: Systematic review with analysis
of referral data pre and post intervention via a manual tracking method.
Methods: Referral and enrollment rates to Phase II Cardiac Rehabilitation
were analyzed before and after implementation of the computerized,
automated referral system. Enrollment and participation data was tracked
manually over an eight month period through utilization of a computerized
database. Results: Prior to implementation of the automated, computerized
system, an average of 58 patients per month were referred to outpatient
cardiac rehabilitation after hospitalization following an MI, CABG, heart
valve surgery or PTCA procedure via a traditional referral strategy. Of
these, only 12 patients per month enrolled in the outpatient cardiac
rehabilitation program (20.6% participation rate). After implementation of
the automated, computerized system, an average of 200 referrals per month
were received (increased referral rate by 243%). When sorted to exclude
inappropriate patients (i.e.: those out of town or with an inappropriate
diagnosis), enrollment increased to average 20 patients per month, which
was a 67% increase. Conclusions: The implementation of a computerized,
automated referral system significantly improved physician referral and
patient enrollment rates. The results of this study support broad
implementation of automated referral systems in providing evidence-based
care to a wider population of patients.

<31>
Accession Number
70490477
Authors
Simons W.R.
Institution
(Simons) Global Health Economics and Outcomes Research Inc., Summit, NJ,
United States
Title
Burden of proof...proof of principle: Replication quantification,
replication and validation...standards of evidence in outcomes research
surrogate endpoints for all-cause mortality.
Source
Value in Health. Conference: 16th Annual International Meeting of the
International Society for Pharmacoeconomics and Outcomes Research, ISPOR
2011 Baltimore, MD United States. Conference Start: 20110521 Conference
End: 20110525. Conference Publication: (var.pagings). 14 (3) (pp A6),
2011. Date of Publication: May 2011.
Publisher
Elsevier Ltd
Abstract
OBJECTIVES: To demonstrate replication of the quantification of
relationships between surrogates and endpoints as well as reconciliation
with previous epidemio- logical studies; original studies for heart rate
as a surrogatefor all-cause mortality, pain management and
gastrointestinal adverse events, and treatment for diabetes and HbA1c and
HbA1c and complications. METHODS: For heart rate, three epide- miological
studies from three countries using a Weibull survival analysis and
Generalized Estimating Equations were used; namely, the Coronary Artery
Surgery Study (CASS), the Copenhagen City Heart Study (CCHS) and the
General Practitioner Research Network (GPRN). These equations reproduced a
meta-regression and meta-analysis of all available placebo-controlled
clinical trials with heart rate as a prognostic factor for all-cause
mortality. For pain, data consisted of 2005 Health Care Utilization
Project (HCUP) and Premier. Logistic regressions were used to obtain
evaluate and compare odds-ratios. In diabetes, Generalized Estimating
Equations (GEE) allowing serially correlated behavior with repeated HbA1c
reading at variable frequencies and durations between their measurement.
RESULTS: Heart is consistently prognostic for all-cause mortality.
Moreover, its quantification is consistent, 0.00694 (P<0.001) in CASS and
0.00683 (P<0.001) in CCHS (1981-1983) and 0.00717 in CCHS (1991-1993) with
the Weibull. With the GEE, the coefficient is 0.0268 (P=0.006) in GPRN,
0.0249 (P=0.008) in the meta-regression of controlled clinical trials, and
0.01595 in the GEE with CCHS data. All three equations reproduced the
published clinical trials with odd-ratios within 1/100ths.Conditional
odds-ratios were replicated in measure between the two datasets for fecal
impaction, postoperative illeus, other bowel obstruction, vomiting and
abdominal pain. The diabetic equations were replicated exactly in 3
countries, treatment and HbA1c and complications with coefficients within
1/100th in patients with newly diagnosed T2DM. CONCLUSIONS: These are
three studies where the quantification of the relationship between a
surrogate and and endpoint have beed replicated with precision and
subsequently applied to clinical trials.