EMBASE Cardiac Update AutoAlert: EPICORE Cardiac Surgery Blogger2

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<1>
Accession Number
20160396027
Author
Akerblom A.; Clare R.M.; Lokhnygina Y.; Wallentin L.; Held C.; Van De Werf
F.; Moliterno D.J.; Patel U.D.; Leonardi S.; Armstrong P.W.; Harrington
R.A.; White H.D.; Aylward P.E.; Mahaffey K.W.; Tricoci P.
Institution
(Akerblom, Clare, Lokhnygina, Patel, Tricoci) Duke Clinical Research
Institute, Durham, NC, United States
(Akerblom, Wallentin, Held) Department of Medical Sciences, Cardiology,
Uppsala University, Uppsala, Sweden
(Akerblom, Wallentin, Held) Uppsala Clinical Research Center, Uppsala,
Sweden
(Van De Werf) Department of Cardiology, University of Leuven, Leuven,
Belgium
(Moliterno) Gill Heart Institute and Division of Cardiovascular Medicine,
University of Kentucky, Lexington, KY, United States
(Leonardi) Fondazione IRCCS Policlinico San Matteo, Pavia, Italy
(Armstrong) Division of Cardiology, University of Alberta, Edmonton,
Canada
(Harrington, Mahaffey) Department of Medicine, Stanford University,
Stanford, CA, United States
(White) Green Lane Cardiovascular Service, Auckland City Hospital,
Auckland, New Zealand
(Aylward) South Australian Health and Medical Research Institute, Flinders
University and Medical Centre, Adelaide, Australia
Title
Albuminuria and cardiovascular events in patients with acute coronary
syndromes: Results from the TRACER trial.
Source
American Heart Journal. 178 (pp 1-8), 2016. Date of Publication: 01 Aug
2016.
Publisher
Mosby Inc.
Abstract
Background Albuminuria is associated with cardiovascular (CV) outcomes. We
evaluated albuminuria, alone and in combination with estimated glomerular
filtration rate (EGFR), as a predictor of mortality and CV morbidity in
12,944 patients with non-ST-segment elevation acute coronary syndromes.
Methods Baseline serum creatinine and urinary dipsticks were obtained,
with albuminuria stratified into no/trace albuminuria, microalbuminuria
(>30 but <300 mg/dL), or macroalbuminuria (>300 mg/dL). Kaplan-Meier rates
and proportional Cox hazards models of CV death, overall mortality, CV
death or myocardial infarction (MI), and bleeding were calculated.
Incidence of acute kidney injury, identified by adverse event reporting
and creatinine increase (absolute >0.3 mg/dL or relative >50%), was
descriptively reported. Results Both dipstick albuminuria and creatinine
values were available in 9473 patients (73.2%). More patients with
macroalbuminuria, versus no/trace albuminuria, had diabetes (66% vs 27%)
or hypertension (86% vs 68%). Rates for CV death and overall mortality per
strata were 3.1% and 4.8% (no/trace albuminuria); 5.8% and 9.0%
(microalbuminuria); and 7.7% and 12.6% (macroalbuminuria) at 2 years of
follow-up. Corresponding rates for CV death or MI were 12.2%, 16.9%, and
23.5%, respectively. Observed acute kidney injury rates were 0.6%, 1.2%,
and 2.9% (n = 79), respectively. Adjusted HRs for macroalbuminuria on CV
mortality were 1.65 (95% CI 1.15-2.37), and after adjustment with EGFR,
1.37 (95% CI 0.93-2.01). Corresponding HRs for overall mortality were 1.82
(95% CI 1.37-2.42) and 1.47 (95% CI 1.08-1.98). Conclusions High-risk
patients with non-ST-segment elevation acute coronary syndromes and
albuminuria have increased morbidity and increased overall mortality
independent of EGFR.

<2>
Accession Number
26203535
Author
Shahi V.; Brinjikji W.; Murad M.H.; Asirvatham S.J.; Kallmes D.F.
Institution
(Shahi) From the Mayo Medical School, College of Medicine, Mayo Clinic,
Rochester, Minn (V.S.); and Department of Radiology (W.B., D.F.K.), Center
for Science of Healthcare Delivery (M.H.M.), and Department of Cardiology
(S.J.A.), Mayo Clinic, 200 First St SW, Rochester, MN 55905
(Brinjikji) From the Mayo Medical School, College of Medicine, Mayo
Clinic, Rochester, Minn (V.S.); and Department of Radiology (W.B.,
D.F.K.), Center for Science of Healthcare Delivery (M.H.M.), and
Department of Cardiology (S.J.A.), Mayo Clinic, 200 First St SW,
Rochester, MN 55905
(Murad) From the Mayo Medical School, College of Medicine, Mayo Clinic,
Rochester, Minn (V.S.); and Department of Radiology (W.B., D.F.K.), Center
for Science of Healthcare Delivery (M.H.M.), and Department of Cardiology
(S.J.A.), Mayo Clinic, 200 First St SW, Rochester, MN 55905
(Asirvatham) From the Mayo Medical School, College of Medicine, Mayo
Clinic, Rochester, Minn (V.S.); and Department of Radiology (W.B.,
D.F.K.), Center for Science of Healthcare Delivery (M.H.M.), and
Department of Cardiology (S.J.A.), Mayo Clinic, 200 First St SW,
Rochester, MN 55905
(Kallmes) From the Mayo Medical School, College of Medicine, Mayo Clinic,
Rochester, Minn (V.S.); and Department of Radiology (W.B., D.F.K.), Center
for Science of Healthcare Delivery (M.H.M.), and Department of Cardiology
(S.J.A.), Mayo Clinic, 200 First St SW, Rochester, MN 55905
Title
Safety of Uninterrupted Warfarin Therapy in Patients Undergoing
Cardiovascular Endovascular Procedures: A Systematic Review and
Meta-Analysis.
Source
Radiology. 278 (2) (pp 383-394), 2016. Date of Publication: 01 Feb 2016.
Abstract
PURPOSE: To conduct a systematic review and meta-analysis of complication
rates and outcomes in patients undergoing endovascular procedures who
receive uninterrupted versus interrupted warfarin therapy.
MATERIALS AND METHODS: Literature published between 1990 and 2014 was
searched for reports of comparative studies of vascular procedures.
Information on periprocedural complications and patient deaths less than
30 days after the procedure was extracted. A random effects model was used
and odds ratios (ORs) were reported. An OR of less than 1 was considered
to indicate lower risk of the outcome with uninterrupted warfarin therapy.
Meta-analysis was conducted by using meta-analysis software.
RESULTS: A total of 27 studies of 20,376 patients were included. For
arterial procedures, there were no significant differences between the
uninterrupted and interrupted warfarin therapy groups in access site
hematoma (OR, 0.59; 95% confidence interval [CI]: 0.33, 1.03; P = .06),
any bleeding complications (OR, 0.56; 95% CI: 0.30, 1.06; P = .07),
mortality (OR, 1.40; 95% CI: 0.37, 5.25; P = .62), intracranial hemorrhage
(OR, 0.55; 95% CI: 0.03, 8.91; P = .68), ischemic stroke (OR, 0.85; 95%
CI: 0.12, 5.84; P = .87), and major bleeding (OR, 0.56; 95% CI: 0.21,
1.51; P = .25). For venous procedures, uninterrupted warfarin was
associated with lower odds of access site hematoma (OR, 0.70; 95% CI:
0.50, 0.99; P = .04), any bleeding complications (OR, 0.61; 95% CI: 0.48,
0.77; P < .01), ischemic stroke (OR, 0.21; 95% CI: 0.10, 0.45; P < .01),
and major bleeding (OR, 0.64; 95% CI: 0.51, 0.80; P < .01). For arterial
and venous procedures combined, uninterrupted warfarin was associated with
lower odds of access site hematoma (OR, 0.68; 95% CI: 0.51, 0.91; P =
.01), bleeding complications (OR, 0.59; 95% CI: 0.48, 0.74; P < .01),
ischemic stroke (OR, 0.25; 95% CI: 0.12, 0.50; P < .01), and major
bleeding (OR, 0.61; 95% CI: 0.49, 0.77; P < .01). Heterogeneity in most
analyses was low, and confidence in the estimates was moderate.
CONCLUSION: Uninterrupted perioperative warfarin therapy is safe for
patients undergoing arterial procedures, but interrupted warfarin may be
preferred for those undergoing venous procedures; no differences in
outcome rates were found in the randomized controlled trials. Future
studies should be performed to validate these results.

<3>
Accession Number
26576750
Author
Kim J.E.; Song S.W.; Kim J.Y.; Lee H.J.; Chung K.-H.; Shim Y.H.
Institution
(Kim) Department of Anesthesiology and Pain Medicine, Anesthesia and Pain
Research Institute, Yonsei University College of Medicine, Seoul, Korea
(Song) Department of Thoracic and Cardiovascular Surgery, Yonsei
University College of Medicine, Seoul, Korea
(Kim) Department of Anesthesiology and Pain Medicine, Ajou University
School of Medicine, Suwon, Korea
(Lee) Department of Anesthesiology and Pain Medicine, Anesthesia and Pain
Research Institute, Yonsei University College of Medicine, Seoul, Korea
(Chung) Department of Anesthesiology and Pain Medicine, CHA Bundang
Medical Center, CHA University, Seongnam, Korea
(Shim) Department of Anesthesiology and Pain Medicine, Anesthesia and Pain
Research Institute, Yonsei University College of Medicine, Seoul, Korea.
Electronic address: tren125@yuhs.ac
Title
Effect of a Single Bolus of Erythropoietin on Renoprotection in Patients
Undergoing Thoracic Aortic Surgery With Moderate Hypothermic Circulatory
Arrest.
Source
The Annals of thoracic surgery. 101 (2) (pp 690-696), 2016. Date of
Publication: 01 Feb 2016.
Abstract
BACKGROUND: Acute kidney injury (AKI) is associated with high morbidity
and mortality. Recombinant human erythropoietin has been shown to exert
cytoprotection against ischemia. This study examined the effect of
erythropoietin in preventing AKI during thoracic aortic surgery with
moderate hypothermic circulatory arrest.
METHODS: In this double-blind, randomized study, 66 patients undergoing
thoracic aortic surgery with moderate hypothermic circulatory arrest
(target temperature, 28degreeC) randomly received either erythropoietin
500 IU.kg(-1) or the same amount of normal saline intravenously after
anesthesia induction. The primary endpoint was incidence of AKI defined
according to the RIFLE criteria during the first 7 postoperative days.
RESULTS: AKI occurred in 60% of all patients. The two groups did not show
any differences in the incidence and severity of AKI. Also, there was no
difference in the level of serum neutrophil gelatinase-associated
lipocalin between the groups. The cardiac index was higher in the
erythropoietin group, however, immediately after weaning from
cardiopulmonary bypass (p = 0.02). Furthermore, postoperative cardiac
complications and prolonged vasopressor dependence were reduced in the
erythropoietin group (p = 0.04 and p = 0.049, respectively).
CONCLUSIONS: A single bolus administration of erythropoietin 500 IU.kg(-1)
at anesthesia induction failed to provide renoprotection in patients who
underwent thoracic aortic surgery with moderate hypothermic circulatory
arrest. However, erythropoietin significantly reduced cardiac
complications, and lowered the incidence of prolonged vasopressor
dependence.

<4>
Accession Number
26025863
Author
Gargiulo G.; Tamburino C.; Capodanno D.
Institution
(Gargiulo) Division of Cardiology, Ferrarotto Hospital, University of
Catania, Italy
(Tamburino) Division of Cardiology, Ferrarotto Hospital, University of
Catania, Italy; Excellence Through Newest Advances (ETNA) Foundation,
Catania, Italy
(Capodanno) Division of Cardiology, Ferrarotto Hospital, University of
Catania, Italy. Electronic address: dcapodanno@gmail.com
Title
Five-year outcomes of percutaneous coronary intervention versus coronary
artery bypass graft surgery in patients with left main coronary artery
disease: An updated meta-analysis of randomized trials and adjusted
observational studies.
Source
International journal of cardiology. 195 (pp 79-81), 2015. Date of
Publication: 15 Sep 2015.

<5>
Accession Number
26041587
Author
Koea J.; Baldwin P.; Shen J.; Patel B.; Batiller J.; Arnaud A.; Hart J.;
Hammond J.; Fischer C.; James Garden O.
Institution
(Koea) Department of Surgery, Auckland City Hospital, Grafton, New
Zealand.
(Koea) Department of Surgery, North Shore Hospital, Private Bag 93505,
Auckland, 0620, New Zealand.
(Baldwin) Addenbrooke's Hospital, Cambridge, UK
(Shen) Ethicon, Inc., Somerville, NJ, USA
(Patel) Ethicon, Inc., Somerville, NJ, USA
(Batiller) Ethicon, Inc., Somerville, NJ, USA
(Arnaud) Ethicon, Inc., Somerville, NJ, USA
(Hart) Ethicon, Inc., Somerville, NJ, USA
(Hammond) Ethicon, Inc., Somerville, NJ, USA
(Fischer) Weill Cornell Medical College of Cornell University, Houston,
TX, USA
(James Garden) Royal Infirmary of Edinburgh, Edinburgh, UK
Title
Safety and Hemostatic Effectiveness of the Fibrin Pad for Severe
Soft-Tissue Bleeding During Abdominal, Retroperitoneal, Pelvic, and
Thoracic (Non-cardiac) Surgery: A Randomized, Controlled, Superiority
Trial.
Source
World journal of surgery. 39 (11) (pp 2663-2669), 2015. Date of
Publication: 01 Nov 2015.
Abstract
BACKGROUND: In surgery, rapid hemostasis can be required in various
settings and bleeding intensities to minimize complications related to
blood loss. While effective hemostats are available for mild-to-moderate
surgical bleeding, few are effective against challenging severe
hemorrhage. We report the effectiveness and safety of the fibrin pad (FP),
a novel combination hemostat (device/human biologic), in controlling
severe soft-tissue bleeding as compared to the standard of care (SoC).
METHODS: This randomized, controlled, superiority study enrolled subjects
>18 years, requiring elective abdominal, retroperitoneal, pelvic, or
thoracic (non-cardiac) surgery. A severe target bleeding site (TBS) was
identified intra-operatively following which, subjects were randomized to
the FP or the SoC group. Hemostatic status was observed at 4 min (primary
endpoint) and 10 min post-randomization. Safety variables included
TBS-related bleeding and thrombotic events.
RESULTS: At 4 min post-randomization, 50/59 (84.7 %) subjects in the FP
group and 10/32 (31.3%) [Corrected] subjects in the SoC group achieved
hemostasis without needing re-treatment (P < 0.0001). Compared to the SoC
group, the FP group showed better hemostasis at 10 min post-randomization
[58/59 (98.3 %) vs. 28/32 (87.5 %); P = 0.01], lower mean time to
hemostasis (6.1 +/- 13.5 vs. 17.8 +/- 32.0 min), and a less frequent need
for re-treatment (5.1 vs. 53.1 %). The triangular test for binary response
demonstrated the FP to be superior to SoC (95 % CI 1.474-3.290; P <
0.0001). Safety profiles in both groups were similar to those typically
observed after long-duration surgery.
CONCLUSION: The FP is safe and superior to SoC for controlling challenging
severe soft-tissue bleeding encountered during intra-abdominal and
thoracic surgical procedures.

<6>
Accession Number
26796402
Author
Stahli B.E.; Tardif J.-C.; Carrier M.; Gallo R.; Emery R.W.; Robb S.;
Cournoyer D.; Blondeau L.; Johnson D.; Mann J.; Lesperance J.; Guertin
M.-C.; L'Allier P.L.
Title
Effects of P-Selectin Antagonist Inclacumab in Patients Undergoing
Coronary Artery Bypass Graft Surgery: SELECT-CABG Trial.
Source
Journal of the American College of Cardiology. 67 (3) (pp 344-346), 2016.
Date of Publication: 26 Jan 2016.

<7>
Accession Number
27043082
Author
O'Donoghue M.L.; Glaser R.; Cavender M.A.; Aylward P.E.; Bonaca M.P.;
Budaj A.; Davies R.Y.; Dellborg M.; Fox K.A.; Gutierrez J.A.; Hamm C.;
Kiss R.G.; Kovar F.; Kuder J.F.; Im K.A.; Lepore J.J.; Lopez-Sendon J.L.;
Ophuis T.O.; Parkhomenko A.; Shannon J.B.; Spinar J.; Tanguay J.-F.; Ruda
M.; Steg P.G.; Theroux P.; Wiviott S.D.; Laws I.; Sabatine M.S.; Morrow
D.A.
Institution
(O'Donoghue) TIMI Study Group, Cardiovascular Division, Brigham and
Women's Hospital, Boston, Massachusetts
(Glaser) Metabolic Pathways and Cardiovascular Unit, Research and
Development, GlaxoSmithKline, Collegeville, Pennsylvania
(Cavender) TIMI Study Group, Cardiovascular Division, Brigham and Women's
Hospital, Boston, Massachusetts
(Aylward) South Australian Health and Medical Research Institute, Flinders
University Medical Centre, Adelaide, South Australia, Australia
(Bonaca) TIMI Study Group, Cardiovascular Division, Brigham and Women's
Hospital, Boston, Massachusetts
(Budaj) Postgraduate Medical School, Grochowski Hospital, Warsaw, Poland
(Davies) Metabolic Pathways and Cardiovascular Unit, Research and
Development, GlaxoSmithKline, Collegeville, Pennsylvania
(Dellborg) Sahlgrenska University Hospital/Ostra and Sahlgrenska Academy,
University of Gothenburg, Gothenburg, Sweden
(Fox) Centre for Cardiovascular Science, University of Edinburgh,
Edinburgh, Scotland
(Gutierrez) TIMI Study Group, Cardiovascular Division, Brigham and Women's
Hospital, Boston, Massachusetts
(Hamm) Kerckhoff Heart Center, Bad Nauheim, University of Giessen,
Giessen, Germany
(Kiss) Department of Cardiology, Military Hospital, Budapest, Hungary
(Kovar) Department of Internal Medicine I, Jessenius Faculty of Medicine
in Martin, Comenius University in Bratislava, Martin, Slovak Republic
(Kuder) TIMI Study Group, Cardiovascular Division, Brigham and Women's
Hospital, Boston, Massachusetts
(Im) TIMI Study Group, Cardiovascular Division, Brigham and Women's
Hospital, Boston, Massachusetts
(Lepore) Metabolic Pathways and Cardiovascular Unit, Research and
Development, GlaxoSmithKline, Collegeville, Pennsylvania
(Lopez-Sendon) Cardiovascular Division, University Hospital La Paz,
Madrid, Spain
(Ophuis) Canisius-Wilhelmina Hospital, Nijmegen, the Netherlands
(Parkhomenko) Ukranian Strazhesko Institute of Cardiology, Kiev, Ukraine
(Shannon) PAREXEL International, Durham, North Carolina
(Spinar) University Hospital, Jihlavska, Brno, Czech Republic
(Tanguay) Montreal Heart Institute and University of Montreal, Montreal,
Quebec, Canada
(Ruda) Cardiology Research Center, Moscow, Russia
(Steg) Departement Hospitalo-Universitaire FIRE, Hopital Bichat,
Assistance Publique-Hopitaux de Paris, and Universite Paris-Diderot,
Paris, France
(Theroux) Montreal Heart Institute and University of Montreal, Montreal,
Quebec, Canada
(Wiviott) TIMI Study Group, Cardiovascular Division, Brigham and Women's
Hospital, Boston, Massachusetts
(Laws) Metabolic Pathways and Cardiovascular Unit, Research and
Development, GlaxoSmithKline, Collegeville, Pennsylvania
(Sabatine) TIMI Study Group, Cardiovascular Division, Brigham and Women's
Hospital, Boston, Massachusetts
(Morrow) TIMI Study Group, Cardiovascular Division, Brigham and Women's
Hospital, Boston, Massachusetts
Title
Effect of Losmapimod on Cardiovascular Outcomes in Patients Hospitalized
With Acute Myocardial Infarction: A Randomized Clinical Trial.
Source
JAMA. 315 (15) (pp 1591-1599), 2016. Date of Publication: 19 Apr 2016.
Abstract
IMPORTANCE: p38 Mitogen-activated protein kinase (MAPK)-stimulated
inflammation is implicated in atherogenesis, plaque destabilization, and
maladaptive processes in myocardial infarction (MI). Pilot data in a phase
2 trial in non-ST elevation MI indicated that the p38 MAPK inhibitor
losmapimod attenuates inflammation and may improve outcomes.
OBJECTIVE: To evaluate the efficacy and safety of losmapimod on
cardiovascular outcomes in patients hospitalized with an acute myocardial
infarction.
DESIGN, SETTING, AND PATIENTS: LATITUDE-TIMI 60, a randomized,
placebo-controlled, double-blind, parallel-group trial conducted at 322
sites in 34 countries from June 3, 2014, until December 8, 2015. Part A
consisted of a leading cohort (n=3503) to provide an initial assessment of
safety and exploratory efficacy before considering progression to part B
(approximately 22,000 patients). Patients were considered potentially
eligible for enrollment if they had been hospitalized with an acute MI and
had at least 1 additional predictor of cardiovascular risk.
INTERVENTIONS: Patients were randomized to either twice-daily losmapimod
(7.5 mg; n=1738) or matching placebo (n=1765) on a background of
guideline-recommended therapy. Patients were treated for 12 weeks and
followed up for an additional 12 weeks.
MAIN OUTCOMES AND MEASURES: The primary end point was the composite of
cardiovascular death, MI, or severe recurrent ischemia requiring urgent
coronary revascularization with the principal analysis specified at week
12.
RESULTS: In part A, among the 3503 patients randomized (median age, 66
years; 1036 [29.6%] were women), 99.1% had complete ascertainment for the
primary outcome. The primary end point occurred by 12 weeks in 123
patients treated with placebo (7.0%) and 139 patients treated with
losmapimod (8.1%; hazard ratio, 1.16; 95% CI, 0.91-1.47; P=.24). The
on-treatment rates of serious adverse events were 16.0% with losmapimod
and 14.2% with placebo.
CONCLUSIONS AND RELEVANCE: Among patients with acute MI, use of losmapimod
compared with placebo did not reduce the risk of major ischemic
cardiovascular events. The results of this exploratory efficacy study did
not justify proceeding to a larger efficacy trial in the existing patient
population.
TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT02145468.

<8>
Accession Number
27144849
Author
Zheng Z.; Jayaram R.; Jiang L.; Emberson J.; Zhao Y.; Li Q.; Du J.;
Guarguagli S.; Hill M.; Chen Z.; Collins R.; Casadei B.
Institution
(Zheng) From the Department of Cardiovascular Surgery, State Key
Laboratory of Cardiovascular Disease, National Clinical Research Center of
Cardiovascular Diseases, Fuwai Hospital, National Center for
Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking
Union Medical College, Beijing (Z.Z., L.J., Y.Z., Q.L., J.D., Z.C.); and
the Division of Cardiovascular Medicine, Radcliffe Department of Medicine
(R.J., S.G., B.C.), and the Clinical Trial Service Unit and
Epidemiological Studies Unit, Nuffield Department of Population Health
(J.E., M.H., Z.C., R.C.), University of Oxford, Oxford, United Kingdom
(Jayaram) From the Department of Cardiovascular Surgery, State Key
Laboratory of Cardiovascular Disease, National Clinical Research Center of
Cardiovascular Diseases, Fuwai Hospital, National Center for
Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking
Union Medical College, Beijing (Z.Z., L.J., Y.Z., Q.L., J.D., Z.C.); and
the Division of Cardiovascular Medicine, Radcliffe Department of Medicine
(R.J., S.G., B.C.), and the Clinical Trial Service Unit and
Epidemiological Studies Unit, Nuffield Department of Population Health
(J.E., M.H., Z.C., R.C.), University of Oxford, Oxford, United Kingdom
(Jiang) From the Department of Cardiovascular Surgery, State Key
Laboratory of Cardiovascular Disease, National Clinical Research Center of
Cardiovascular Diseases, Fuwai Hospital, National Center for
Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking
Union Medical College, Beijing (Z.Z., L.J., Y.Z., Q.L., J.D., Z.C.); and
the Division of Cardiovascular Medicine, Radcliffe Department of Medicine
(R.J., S.G., B.C.), and the Clinical Trial Service Unit and
Epidemiological Studies Unit, Nuffield Department of Population Health
(J.E., M.H., Z.C., R.C.), University of Oxford, Oxford, United Kingdom
(Emberson) From the Department of Cardiovascular Surgery, State Key
Laboratory of Cardiovascular Disease, National Clinical Research Center of
Cardiovascular Diseases, Fuwai Hospital, National Center for
Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking
Union Medical College, Beijing (Z.Z., L.J., Y.Z., Q.L., J.D., Z.C.); and
the Division of Cardiovascular Medicine, Radcliffe Department of Medicine
(R.J., S.G., B.C.), and the Clinical Trial Service Unit and
Epidemiological Studies Unit, Nuffield Department of Population Health
(J.E., M.H., Z.C., R.C.), University of Oxford, Oxford, United Kingdom
(Zhao) From the Department of Cardiovascular Surgery, State Key Laboratory
of Cardiovascular Disease, National Clinical Research Center of
Cardiovascular Diseases, Fuwai Hospital, National Center for
Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking
Union Medical College, Beijing (Z.Z., L.J., Y.Z., Q.L., J.D., Z.C.); and
the Division of Cardiovascular Medicine, Radcliffe Department of Medicine
(R.J., S.G., B.C.), and the Clinical Trial Service Unit and
Epidemiological Studies Unit, Nuffield Department of Population Health
(J.E., M.H., Z.C., R.C.), University of Oxford, Oxford, United Kingdom
(Li) From the Department of Cardiovascular Surgery, State Key Laboratory
of Cardiovascular Disease, National Clinical Research Center of
Cardiovascular Diseases, Fuwai Hospital, National Center for
Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking
Union Medical College, Beijing (Z.Z., L.J., Y.Z., Q.L., J.D., Z.C.); and
the Division of Cardiovascular Medicine, Radcliffe Department of Medicine
(R.J., S.G., B.C.), and the Clinical Trial Service Unit and
Epidemiological Studies Unit, Nuffield Department of Population Health
(J.E., M.H., Z.C., R.C.), University of Oxford, Oxford, United Kingdom
(Du) From the Department of Cardiovascular Surgery, State Key Laboratory
of Cardiovascular Disease, National Clinical Research Center of
Cardiovascular Diseases, Fuwai Hospital, National Center for
Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking
Union Medical College, Beijing (Z.Z., L.J., Y.Z., Q.L., J.D., Z.C.); and
the Division of Cardiovascular Medicine, Radcliffe Department of Medicine
(R.J., S.G., B.C.), and the Clinical Trial Service Unit and
Epidemiological Studies Unit, Nuffield Department of Population Health
(J.E., M.H., Z.C., R.C.), University of Oxford, Oxford, United Kingdom
(Guarguagli) From the Department of Cardiovascular Surgery, State Key
Laboratory of Cardiovascular Disease, National Clinical Research Center of
Cardiovascular Diseases, Fuwai Hospital, National Center for
Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking
Union Medical College, Beijing (Z.Z., L.J., Y.Z., Q.L., J.D., Z.C.); and
the Division of Cardiovascular Medicine, Radcliffe Department of Medicine
(R.J., S.G., B.C.), and the Clinical Trial Service Unit and
Epidemiological Studies Unit, Nuffield Department of Population Health
(J.E., M.H., Z.C., R.C.), University of Oxford, Oxford, United Kingdom
(Hill) From the Department of Cardiovascular Surgery, State Key Laboratory
of Cardiovascular Disease, National Clinical Research Center of
Cardiovascular Diseases, Fuwai Hospital, National Center for
Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking
Union Medical College, Beijing (Z.Z., L.J., Y.Z., Q.L., J.D., Z.C.); and
the Division of Cardiovascular Medicine, Radcliffe Department of Medicine
(R.J., S.G., B.C.), and the Clinical Trial Service Unit and
Epidemiological Studies Unit, Nuffield Department of Population Health
(J.E., M.H., Z.C., R.C.), University of Oxford, Oxford, United Kingdom
(Chen) From the Department of Cardiovascular Surgery, State Key Laboratory
of Cardiovascular Disease, National Clinical Research Center of
Cardiovascular Diseases, Fuwai Hospital, National Center for
Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking
Union Medical College, Beijing (Z.Z., L.J., Y.Z., Q.L., J.D., Z.C.); and
the Division of Cardiovascular Medicine, Radcliffe Department of Medicine
(R.J., S.G., B.C.), and the Clinical Trial Service Unit and
Epidemiological Studies Unit, Nuffield Department of Population Health
(J.E., M.H., Z.C., R.C.), University of Oxford, Oxford, United Kingdom
(Collins) From the Department of Cardiovascular Surgery, State Key
Laboratory of Cardiovascular Disease, National Clinical Research Center of
Cardiovascular Diseases, Fuwai Hospital, National Center for
Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking
Union Medical College, Beijing (Z.Z., L.J., Y.Z., Q.L., J.D., Z.C.); and
the Division of Cardiovascular Medicine, Radcliffe Department of Medicine
(R.J., S.G., B.C.), and the Clinical Trial Service Unit and
Epidemiological Studies Unit, Nuffield Department of Population Health
(J.E., M.H., Z.C., R.C.), University of Oxford, Oxford, United Kingdom
(Casadei) From the Department of Cardiovascular Surgery, State Key
Laboratory of Cardiovascular Disease, National Clinical Research Center of
Cardiovascular Diseases, Fuwai Hospital, National Center for
Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking
Union Medical College, Beijing (Z.Z., L.J., Y.Z., Q.L., J.D., Z.C.); and
the Division of Cardiovascular Medicine, Radcliffe Department of Medicine
(R.J., S.G., B.C.), and the Clinical Trial Service Unit and
Epidemiological Studies Unit, Nuffield Department of Population Health
(J.E., M.H., Z.C., R.C.), University of Oxford, Oxford, United Kingdom
Title
Perioperative Rosuvastatin in Cardiac Surgery.
Source
The New England journal of medicine. 374 (18) (pp 1744-1753), 2016. Date
of Publication: 05 May 2016.
Abstract
BACKGROUND: Complications after cardiac surgery are common and lead to
substantial increases in morbidity and mortality. Meta-analyses of small
randomized trials have suggested that perioperative statin therapy can
prevent some of these complications.
METHODS: We randomly assigned 1922 patients in sinus rhythm who were
scheduled for elective cardiac surgery to receive perioperative
rosuvastatin (at a dose of 20 mg daily) or placebo. The primary outcomes
were postoperative atrial fibrillation within 5 days after surgery, as
assessed by Holter electrocardiographic monitoring, and myocardial injury
within 120 hours after surgery, as assessed by serial measurements of the
cardiac troponin I concentration. Secondary outcomes included major
in-hospital adverse events, duration of stay in the hospital and intensive
care unit, left ventricular and renal function, and blood biomarkers.
RESULTS: The concentrations of low-density lipoprotein cholesterol and
C-reactive protein after surgery were lower in patients assigned to
rosuvastatin than in those assigned to placebo (P<0.001). However, the
rate of postoperative atrial fibrillation did not differ significantly
between the rosuvastatin group and the placebo group (21.1% and 20.5%,
respectively; odds ratio 1.04; 95% confidence interval [CI], 0.84 to 1.30;
P=0.72), nor did the area under the troponin I-release curve (102 ngxhour
per milliliter and 100 ngxhour per milliliter, respectively; between-group
difference, 1%; 95% CI, -9 to 13; P=0.80). Subgroup analyses did not
indicate benefit in any category of patient. Rosuvastatin therapy did not
result in beneficial effects on any of the secondary outcomes but was
associated with a significant absolute (+/-SE) excess of 5.4+/-1.9
percentage points in the rate of postoperative acute kidney injury
(P=0.005).
CONCLUSIONS: In this trial, perioperative statin therapy did not prevent
postoperative atrial fibrillation or perioperative myocardial damage in
patients undergoing elective cardiac surgery. Acute kidney injury was more
common with rosuvastatin. (Funded by the British Heart Foundation and
others; STICS ClinicalTrials.gov number, NCT01573143.).

<9>
Accession Number
26595100
Author
Strojek K.; Raz I.; Jermendy G.; Gitt A.K.; Liu R.; Zhang Q.; Jacober
S.J.; Milicevic Z.
Institution
(Strojek) Internal Diseases (K.S.), Diabetology and Cardiometabolic
Diseases, Silesian Centre of Heart Diseases, Silesian Medical University,
41-800 Zabrze, Poland; Diabetes Unit (I.R.), Internal Medicine Department,
Hadassah Hebrew University Medical Center, Jerusalem 91120, Israel;
Medical Department (G.J.), Bajcsy-Zsilinszky Teaching Hospital, Budapest,
1106 Hungary; Cardiology (A.K.G.), Herzzentrum Ludwigshafen, Medizinische
Klinik B, 67063 Ludwigshafen, Germany; Eli Lilly and Company (R.L., Q.Z.,
S.J.J.), Indianapolis, Indiana 46285; and Lilly Regional GmbH (Z.M.), Eli
Lilly and Company, 1030 Vienna, Austria
(Raz) Internal Diseases (K.S.), Diabetology and Cardiometabolic Diseases,
Silesian Centre of Heart Diseases, Silesian Medical University, 41-800
Zabrze, Poland; Diabetes Unit (I.R.), Internal Medicine Department,
Hadassah Hebrew University Medical Center, Jerusalem 91120, Israel;
Medical Department (G.J.), Bajcsy-Zsilinszky Teaching Hospital, Budapest,
1106 Hungary; Cardiology (A.K.G.), Herzzentrum Ludwigshafen, Medizinische
Klinik B, 67063 Ludwigshafen, Germany; Eli Lilly and Company (R.L., Q.Z.,
S.J.J.), Indianapolis, Indiana 46285; and Lilly Regional GmbH (Z.M.), Eli
Lilly and Company, 1030 Vienna, Austria
(Jermendy) Internal Diseases (K.S.), Diabetology and Cardiometabolic
Diseases, Silesian Centre of Heart Diseases, Silesian Medical University,
41-800 Zabrze, Poland; Diabetes Unit (I.R.), Internal Medicine Department,
Hadassah Hebrew University Medical Center, Jerusalem 91120, Israel;
Medical Department (G.J.), Bajcsy-Zsilinszky Teaching Hospital, Budapest,
1106 Hungary; Cardiology (A.K.G.), Herzzentrum Ludwigshafen, Medizinische
Klinik B, 67063 Ludwigshafen, Germany; Eli Lilly and Company (R.L., Q.Z.,
S.J.J.), Indianapolis, Indiana 46285; and Lilly Regional GmbH (Z.M.), Eli
Lilly and Company, 1030 Vienna, Austria
(Gitt) Internal Diseases (K.S.), Diabetology and Cardiometabolic Diseases,
Silesian Centre of Heart Diseases, Silesian Medical University, 41-800
Zabrze, Poland; Diabetes Unit (I.R.), Internal Medicine Department,
Hadassah Hebrew University Medical Center, Jerusalem 91120, Israel;
Medical Department (G.J.), Bajcsy-Zsilinszky Teaching Hospital, Budapest,
1106 Hungary; Cardiology (A.K.G.), Herzzentrum Ludwigshafen, Medizinische
Klinik B, 67063 Ludwigshafen, Germany; Eli Lilly and Company (R.L., Q.Z.,
S.J.J.), Indianapolis, Indiana 46285; and Lilly Regional GmbH (Z.M.), Eli
Lilly and Company, 1030 Vienna, Austria
(Liu) Internal Diseases (K.S.), Diabetology and Cardiometabolic Diseases,
Silesian Centre of Heart Diseases, Silesian Medical University, 41-800
Zabrze, Poland; Diabetes Unit (I.R.), Internal Medicine Department,
Hadassah Hebrew University Medical Center, Jerusalem 91120, Israel;
Medical Department (G.J.), Bajcsy-Zsilinszky Teaching Hospital, Budapest,
1106 Hungary; Cardiology (A.K.G.), Herzzentrum Ludwigshafen, Medizinische
Klinik B, 67063 Ludwigshafen, Germany; Eli Lilly and Company (R.L., Q.Z.,
S.J.J.), Indianapolis, Indiana 46285; and Lilly Regional GmbH (Z.M.), Eli
Lilly and Company, 1030 Vienna, Austria
(Zhang) Internal Diseases (K.S.), Diabetology and Cardiometabolic
Diseases, Silesian Centre of Heart Diseases, Silesian Medical University,
41-800 Zabrze, Poland; Diabetes Unit (I.R.), Internal Medicine Department,
Hadassah Hebrew University Medical Center, Jerusalem 91120, Israel;
Medical Department (G.J.), Bajcsy-Zsilinszky Teaching Hospital, Budapest,
1106 Hungary; Cardiology (A.K.G.), Herzzentrum Ludwigshafen, Medizinische
Klinik B, 67063 Ludwigshafen, Germany; Eli Lilly and Company (R.L., Q.Z.,
S.J.J.), Indianapolis, Indiana 46285; and Lilly Regional GmbH (Z.M.), Eli
Lilly and Company, 1030 Vienna, Austria
(Jacober) Internal Diseases (K.S.), Diabetology and Cardiometabolic
Diseases, Silesian Centre of Heart Diseases, Silesian Medical University,
41-800 Zabrze, Poland; Diabetes Unit (I.R.), Internal Medicine Department,
Hadassah Hebrew University Medical Center, Jerusalem 91120, Israel;
Medical Department (G.J.), Bajcsy-Zsilinszky Teaching Hospital, Budapest,
1106 Hungary; Cardiology (A.K.G.), Herzzentrum Ludwigshafen, Medizinische
Klinik B, 67063 Ludwigshafen, Germany; Eli Lilly and Company (R.L., Q.Z.,
S.J.J.), Indianapolis, Indiana 46285; and Lilly Regional GmbH (Z.M.), Eli
Lilly and Company, 1030 Vienna, Austria
(Milicevic) Internal Diseases (K.S.), Diabetology and Cardiometabolic
Diseases, Silesian Centre of Heart Diseases, Silesian Medical University,
41-800 Zabrze, Poland; Diabetes Unit (I.R.), Internal Medicine Department,
Hadassah Hebrew University Medical Center, Jerusalem 91120, Israel;
Medical Department (G.J.), Bajcsy-Zsilinszky Teaching Hospital, Budapest,
1106 Hungary; Cardiology (A.K.G.), Herzzentrum Ludwigshafen, Medizinische
Klinik B, 67063 Ludwigshafen, Germany; Eli Lilly and Company (R.L., Q.Z.,
S.J.J.), Indianapolis, Indiana 46285; and Lilly Regional GmbH (Z.M.), Eli
Lilly and Company, 1030 Vienna, Austria
Title
Factors Associated With Cardiovascular Events in Patients With Type 2
Diabetes and Acute Myocardial Infarction.
Source
The Journal of clinical endocrinology and metabolism. 101 (1) (pp
243-253), 2016. Date of Publication: 01 Jan 2016.
Abstract
CONTEXT: Decreasing risk of cardiovascular (CV) disease remains a
challenge to survival in type 2 diabetes.
OBJECTIVE: The objective was to assess the association between
demographic, glycemic, and other clinical factors and CV risk in the
Hyperglycemia and Its Effect After Acute Myocardial Infarction on
Cardiovascular Outcomes in Patients With Type 2 Diabetes Mellitus trial.
DESIGN, SETTINGS, PARTICIPANTS, AND INTERVENTION: We used discrete-time
survival tree analysis to examine data collected for up to 4.6 years in
1115 patients with type 2 diabetes mellitus experiencing acute myocardial
infarction (MI) less than or equal to 18 days before enrollment.
MAIN OUTCOME MEASURES: The primary objective was to identify demographic,
glycemic, and CV risk factors best separating survival curves over time
for a composite end point: CV death, nonfatal MI, nonfatal stroke,
hospitalization for acute coronary syndromes, or coronary
revascularization planned after randomization.
RESULTS: Average change across visits in mean 2-hour blood glucose level
after meals was associated with the greatest difference in event-free
survival probability for the primary end point: mean time to 75%
event-free survival for an average change across visits less than or equal
to -0.14 mmol/L, 73.48 weeks; for visits with average change more -0.14
mmol/L, 29.10 weeks. An average change across visits in the hemoglobin A1c
level less than or equal to -0.92% (-10.06 mmol/mol) and the absence of a
history of stroke or acute MI increased CV event-free survival time
further. Fasting blood glucose and randomized insulin treatment strategy
were weak predicting factors of event-free survival.
CONCLUSIONS: Postprandial glycemia should be considered a potential target
in trials to reduce CV morbidity and mortality in type 2 diabetes
mellitus.

<10>
Accession Number
26771733
Author
Wilczynski M.; Wybraniec M.T.; Milewski K.; Sanak M.; Wita K.; Buldak L;
Kondys M.; Buszman P.; Bochenek A.
Institution
(Wilczynski, Wybraniec, Milewski, Sanak, Wita, Buldak, Kondys, Buszman,
Bochenek) Department of Cardiac Surgery, Medical University of Silesia,
Katowice, Poland - miroslaw.wilczynski@cardiosurg.pl
Title
Eptifibatide infusion versus placebo in high risk patients with non-ST
segment elevation acute coronary syndromes managed with urgent coronary
artery bypass graft surgery. A prospective multicenter randomized
placebo-controlled clinical trial.
Source
The Journal of cardiovascular surgery. 57 (1) (pp 100-110), 2016. Date of
Publication: 01 Feb 2016.
Abstract
BACKGROUND: This randomized prospective clinical trial aimed to evaluate
safety and efficacy of preoperative use of eptifibatide in high risk
patients with non-ST-segment elevation acute coronary syndrome (NSTE-ACS),
requiring urgent coronary artery bypass graft surgery (CABG).
METHODS: A total of 140 patients with NSTE-ACS eligible for urgent
surgical revascularization received either eptifibatide (bolus plus
infusion) 12-48 hours prior to surgery (N.=72 patients) or placebo (normal
saline; N.=68 patients) followed by routinely administered enoxaparin and
aspirin. Patients were regarded as unsuitable for percutaneous coronary
intervention by the heart team. CABG was performed 4 hours after
discontinuation of eptifibatide or placebo infusion. The primary end point
was major adverse cardiac and cerebrovascular events (MACCE) defined as
death, nonfatal myocardial infarction (MI), stroke and the need for
rehospitalization due to recurrent ischemia at 12-month follow-up.
Secondary endpoints included MACCE rate at 1 month, bleeding
complications, platelet inhibition efficacy and correlation of platelet
activity with MACCE rate.
RESULTS: Cumulative one year MACCE rate was 35% vs. 14% in the control and
treated group respectively (P=0.012). Mortality rate at 30 days follow-up
was 10% vs. 3% (P=0.021) and was not changed at 12-month follow-up. There
was a significant difference between both groups regarding perioperative
MI (22% vs. 8%, P=0.03). The rates of stroke, blood loss and blood
transfusion were similar in both groups.
CONCLUSION: Preoperative use of eptifibatide vs. placebo is linked to
significantly reduced 12-month MACCE rate in patients with NSTE-ACS
requiring urgent CABG, while it simultaneously seems not to confer a
greater risk of postoperative bleeding.

<11>
Accession Number
26771732
Author
Xu Z.; Wang Z.P.; Ou J.S.; Yin S.L.; Liu L.J.; Zhang X.
Institution
(Xu, Wang, Ou, Yin, Liu, Zhang) Division of Cardiac Surgery, the First
Affiliated Hospital of Sun Yat-sen University, Guangzhou, Guangdong, China
- himybox@126.com
Title
Is low anticoagulation intensity more beneficial for patients with
bileaflet mechanical mitral valves? A meta-analysis.
Source
The Journal of cardiovascular surgery. 57 (1) (pp 90-99), 2016. Date of
Publication: 01 Feb 2016.
Abstract
BACKGROUND: For the mitral valve replacement (MVR) using the lowest
thrombogenic risk bileaflet valves (St. Jude Medical [St Paul, MN, USA],
Carbomedics [Austin, TX, USA] and On-X [Austin, TX, USA]), excellent
results can be achieved by adopting the anticoagulation intensity (median
INR<2.5) which is lower than the recommended intensity (INR:2.5~3.5). Our
aim was to provide a pooled estimate of potential benefit from clinical
studies using low anticoagulation intensity and high intensity in these
patients.
METHODS: Relevant studies published before February 2014 were searched
through a number of digital databases (MEDLINE, EMBASE, Cochrane Library,
etc.). They were pooled by SPSS19.0 using the random effect method in
three fields: occurrence rate of major thromboembolism, major hemorrhage
and major total events. Fourteen studies with 3595 patients were included.
The follow-up period was 12,846.6 patient-years.
RESULTS: Pooled estimates indicated reduction in major hemorrhage
(RR:0.420, 95%CI: 0.296~0.595, P<0.001) and major total events (RR: 0.738,
95%CI: 0.604~0.902, P=0.003) in the low intensity group. No difference was
noted in major thromboembolism (RR: 1.045, 95%CI: 0.814~1.341, P=0.75).
CONCLUSION: Compared with the recommended high intensity, low
anticoagulation intensity (median INR<2.5) may be more beneficial for the
MVR patients using the lowest thrombogenic risk bileaflet valves. We
recommended an INR between 2.0 and 2.5, with a median INR of 2.3 for these
MVR patients.

<12>
[Use Link to view the full text]
Accession Number
26555329
Author
Alexander K.P.; Weisz G.; Prather K.; James S.; Mark D.B.; Anstrom K.J.;
Davidson-Ray L.; Witkowski A.; Mulkay A.J.; Osmukhina A.; Farzaneh-Far R.;
Ben-Yehuda O.; Stone G.W.; Ohman E.M.
Institution
(Alexander) From Duke Clinical Research Institute and Duke University,
Durham, NC (K.P.A., K.P., D.B.M., K.J.A., L.D.-R., E.M.O.); Shaare Zedek
Medical Center, Jerusalem, Israel (G.W.); Cardiovascular Research
Foundation, New York (G.W., O.B.-Y.); Department of Medical Sciences,
Cardiology, Uppsala University, Sweden (S.J.); Department of
Interventional Cardiology & Angiology, Institute of Cardiology, Warsaw,
Poland (A.W.); Holy Name Medical Center, Hackensack, NJ (A.J.M.); Gilead
Sciences Inc, Foster City, CA (A.O., R.F.-F.); and New York Presbyterian
Hospital, Columbia University Medical Center (O.B.-Y., G.W.S.).
karen.alexander@duke.edu
(Weisz) From Duke Clinical Research Institute and Duke University, Durham,
NC (K.P.A., K.P., D.B.M., K.J.A., L.D.-R., E.M.O.); Shaare Zedek Medical
Center, Jerusalem, Israel (G.W.); Cardiovascular Research Foundation, New
York (G.W., O.B.-Y.); Department of Medical Sciences, Cardiology, Uppsala
University, Sweden (S.J.); Department of Interventional Cardiology &
Angiology, Institute of Cardiology, Warsaw, Poland (A.W.); Holy Name
Medical Center, Hackensack, NJ (A.J.M.); Gilead Sciences Inc, Foster City,
CA (A.O., R.F.-F.); and New York Presbyterian Hospital, Columbia
University Medical Center (O.B.-Y., G.W.S.)
(Prather) From Duke Clinical Research Institute and Duke University,
Durham, NC (K.P.A., K.P., D.B.M., K.J.A., L.D.-R., E.M.O.); Shaare Zedek
Medical Center, Jerusalem, Israel (G.W.); Cardiovascular Research
Foundation, New York (G.W., O.B.-Y.); Department of Medical Sciences,
Cardiology, Uppsala University, Sweden (S.J.); Department of
Interventional Cardiology & Angiology, Institute of Cardiology, Warsaw,
Poland (A.W.); Holy Name Medical Center, Hackensack, NJ (A.J.M.); Gilead
Sciences Inc, Foster City, CA (A.O., R.F.-F.); and New York Presbyterian
Hospital, Columbia University Medical Center (O.B.-Y., G.W.S.)
(James) From Duke Clinical Research Institute and Duke University, Durham,
NC (K.P.A., K.P., D.B.M., K.J.A., L.D.-R., E.M.O.); Shaare Zedek Medical
Center, Jerusalem, Israel (G.W.); Cardiovascular Research Foundation, New
York (G.W., O.B.-Y.); Department of Medical Sciences, Cardiology, Uppsala
University, Sweden (S.J.); Department of Interventional Cardiology &
Angiology, Institute of Cardiology, Warsaw, Poland (A.W.); Holy Name
Medical Center, Hackensack, NJ (A.J.M.); Gilead Sciences Inc, Foster City,
CA (A.O., R.F.-F.); and New York Presbyterian Hospital, Columbia
University Medical Center (O.B.-Y., G.W.S.)
(Mark) From Duke Clinical Research Institute and Duke University, Durham,
NC (K.P.A., K.P., D.B.M., K.J.A., L.D.-R., E.M.O.); Shaare Zedek Medical
Center, Jerusalem, Israel (G.W.); Cardiovascular Research Foundation, New
York (G.W., O.B.-Y.); Department of Medical Sciences, Cardiology, Uppsala
University, Sweden (S.J.); Department of Interventional Cardiology &
Angiology, Institute of Cardiology, Warsaw, Poland (A.W.); Holy Name
Medical Center, Hackensack, NJ (A.J.M.); Gilead Sciences Inc, Foster City,
CA (A.O., R.F.-F.); and New York Presbyterian Hospital, Columbia
University Medical Center (O.B.-Y., G.W.S.)
(Anstrom) From Duke Clinical Research Institute and Duke University,
Durham, NC (K.P.A., K.P., D.B.M., K.J.A., L.D.-R., E.M.O.); Shaare Zedek
Medical Center, Jerusalem, Israel (G.W.); Cardiovascular Research
Foundation, New York (G.W., O.B.-Y.); Department of Medical Sciences,
Cardiology, Uppsala University, Sweden (S.J.); Department of
Interventional Cardiology & Angiology, Institute of Cardiology, Warsaw,
Poland (A.W.); Holy Name Medical Center, Hackensack, NJ (A.J.M.); Gilead
Sciences Inc, Foster City, CA (A.O., R.F.-F.); and New York Presbyterian
Hospital, Columbia University Medical Center (O.B.-Y., G.W.S.)
(Davidson-Ray) From Duke Clinical Research Institute and Duke University,
Durham, NC (K.P.A., K.P., D.B.M., K.J.A., L.D.-R., E.M.O.); Shaare Zedek
Medical Center, Jerusalem, Israel (G.W.); Cardiovascular Research
Foundation, New York (G.W., O.B.-Y.); Department of Medical Sciences,
Cardiology, Uppsala University, Sweden (S.J.); Department of
Interventional Cardiology & Angiology, Institute of Cardiology, Warsaw,
Poland (A.W.); Holy Name Medical Center, Hackensack, NJ (A.J.M.); Gilead
Sciences Inc, Foster City, CA (A.O., R.F.-F.); and New York Presbyterian
Hospital, Columbia University Medical Center (O.B.-Y., G.W.S.)
(Witkowski) From Duke Clinical Research Institute and Duke University,
Durham, NC (K.P.A., K.P., D.B.M., K.J.A., L.D.-R., E.M.O.); Shaare Zedek
Medical Center, Jerusalem, Israel (G.W.); Cardiovascular Research
Foundation, New York (G.W., O.B.-Y.); Department of Medical Sciences,
Cardiology, Uppsala University, Sweden (S.J.); Department of
Interventional Cardiology & Angiology, Institute of Cardiology, Warsaw,
Poland (A.W.); Holy Name Medical Center, Hackensack, NJ (A.J.M.); Gilead
Sciences Inc, Foster City, CA (A.O., R.F.-F.); and New York Presbyterian
Hospital, Columbia University Medical Center (O.B.-Y., G.W.S.)
(Mulkay) From Duke Clinical Research Institute and Duke University,
Durham, NC (K.P.A., K.P., D.B.M., K.J.A., L.D.-R., E.M.O.); Shaare Zedek
Medical Center, Jerusalem, Israel (G.W.); Cardiovascular Research
Foundation, New York (G.W., O.B.-Y.); Department of Medical Sciences,
Cardiology, Uppsala University, Sweden (S.J.); Department of
Interventional Cardiology & Angiology, Institute of Cardiology, Warsaw,
Poland (A.W.); Holy Name Medical Center, Hackensack, NJ (A.J.M.); Gilead
Sciences Inc, Foster City, CA (A.O., R.F.-F.); and New York Presbyterian
Hospital, Columbia University Medical Center (O.B.-Y., G.W.S.)
(Osmukhina) From Duke Clinical Research Institute and Duke University,
Durham, NC (K.P.A., K.P., D.B.M., K.J.A., L.D.-R., E.M.O.); Shaare Zedek
Medical Center, Jerusalem, Israel (G.W.); Cardiovascular Research
Foundation, New York (G.W., O.B.-Y.); Department of Medical Sciences,
Cardiology, Uppsala University, Sweden (S.J.); Department of
Interventional Cardiology & Angiology, Institute of Cardiology, Warsaw,
Poland (A.W.); Holy Name Medical Center, Hackensack, NJ (A.J.M.); Gilead
Sciences Inc, Foster City, CA (A.O., R.F.-F.); and New York Presbyterian
Hospital, Columbia University Medical Center (O.B.-Y., G.W.S.)
(Farzaneh-Far) From Duke Clinical Research Institute and Duke University,
Durham, NC (K.P.A., K.P., D.B.M., K.J.A., L.D.-R., E.M.O.); Shaare Zedek
Medical Center, Jerusalem, Israel (G.W.); Cardiovascular Research
Foundation, New York (G.W., O.B.-Y.); Department of Medical Sciences,
Cardiology, Uppsala University, Sweden (S.J.); Department of
Interventional Cardiology & Angiology, Institute of Cardiology, Warsaw,
Poland (A.W.); Holy Name Medical Center, Hackensack, NJ (A.J.M.); Gilead
Sciences Inc, Foster City, CA (A.O., R.F.-F.); and New York Presbyterian
Hospital, Columbia University Medical Center (O.B.-Y., G.W.S.)
(Ben-Yehuda) From Duke Clinical Research Institute and Duke University,
Durham, NC (K.P.A., K.P., D.B.M., K.J.A., L.D.-R., E.M.O.); Shaare Zedek
Medical Center, Jerusalem, Israel (G.W.); Cardiovascular Research
Foundation, New York (G.W., O.B.-Y.); Department of Medical Sciences,
Cardiology, Uppsala University, Sweden (S.J.); Department of
Interventional Cardiology & Angiology, Institute of Cardiology, Warsaw,
Poland (A.W.); Holy Name Medical Center, Hackensack, NJ (A.J.M.); Gilead
Sciences Inc, Foster City, CA (A.O., R.F.-F.); and New York Presbyterian
Hospital, Columbia University Medical Center (O.B.-Y., G.W.S.)
(Stone) From Duke Clinical Research Institute and Duke University, Durham,
NC (K.P.A., K.P., D.B.M., K.J.A., L.D.-R., E.M.O.); Shaare Zedek Medical
Center, Jerusalem, Israel (G.W.); Cardiovascular Research Foundation, New
York (G.W., O.B.-Y.); Department of Medical Sciences, Cardiology, Uppsala
University, Sweden (S.J.); Department of Interventional Cardiology &
Angiology, Institute of Cardiology, Warsaw, Poland (A.W.); Holy Name
Medical Center, Hackensack, NJ (A.J.M.); Gilead Sciences Inc, Foster City,
CA (A.O., R.F.-F.); and New York Presbyterian Hospital, Columbia
University Medical Center (O.B.-Y., G.W.S.)
(Ohman) From Duke Clinical Research Institute and Duke University, Durham,
NC (K.P.A., K.P., D.B.M., K.J.A., L.D.-R., E.M.O.); Shaare Zedek Medical
Center, Jerusalem, Israel (G.W.); Cardiovascular Research Foundation, New
York (G.W., O.B.-Y.); Department of Medical Sciences, Cardiology, Uppsala
University, Sweden (S.J.); Department of Interventional Cardiology &
Angiology, Institute of Cardiology, Warsaw, Poland (A.W.); Holy Name
Medical Center, Hackensack, NJ (A.J.M.); Gilead Sciences Inc, Foster City,
CA (A.O., R.F.-F.); and New York Presbyterian Hospital, Columbia
University Medical Center (O.B.-Y., G.W.S.)
Title
Effects of Ranolazine on Angina and Quality of Life After Percutaneous
Coronary Intervention With Incomplete Revascularization: Results From the
Ranolazine for Incomplete Vessel Revascularization (RIVER-PCI) Trial.
Source
Circulation. 133 (1) (pp 39-47), 2016. Date of Publication: 05 Jan 2016.
Abstract
BACKGROUND: Angina often persists or returns in populations following
percutaneous coronary intervention (PCI). We hypothesized that ranolazine
would be effective in reducing angina and improving quality of life (QOL)
in incomplete revascularization (ICR) post-PCI patients.
METHODS AND RESULTS: In RIVER-PCI, 2604 patients with a history of chronic
angina who had ICR post-PCI were randomized 1:1 to oral ranolazine versus
placebo; QOL analyses included 2389 randomized subjects. Angina and QOL
questionnaires were collected at baseline and months 1, 6, and 12.
Ranolazine patients were more likely than placebo to discontinue study
drug by month 6 (20.4% versus 14.1%, P<0.001) and 12 (27.2% versus 21.3%,
P<0.001). Following qualifying index PCI, the primary QOL outcome (Seattle
Angina Questionnaire [SAQ] angina frequency score) improved markedly, but
similarly, in the ranolazine and placebo groups, respectively, from
baseline (67.3+/-24.5 versus 69.7+/-24.0, P=0.01) to month 1 (86.6+/-18.1
versus 85.8+/-18.5, P=0.27) and month 12 (88.4+/-17.8 versus 88.5+/-17.8,
P=0.94). SAQ angina frequency repeated measures did not differ in adjusted
analysis between groups post baseline (mean difference 1.0; 95% CI -0.2,
2.2; P=0.11). Improvement in SAQ angina frequency was observed with
ranolazine at month 6 among diabetics (mean difference 3.3; 95% CI 0.6,
6.1; P=0.02) and those with more angina (baseline SAQ angina frequency
<60; mean difference 3.4; 95% CI 0.6, 6.2; P=0.02), but was not maintained
at month 12.
CONCLUSIONS: Despite ICR following PCI, there was no incremental benefit
in angina or QOL measures by adding ranolazine in this
angiographically-identified population. These measures markedly improved
within 1 month of PCI and persisted up to 1 year in both treatment arms.
CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique
identifier: NCT01442038.

<13>
Accession Number
25479530
Author
Wang J.; Gu C.; Gao M.; Yu W.; Yu Y.
Institution
(Wang) Department of Cardiac Surgery, Beijing An Zhen Hospital, Capital
Medical University, Beijing 100029, China
(Gu) Department of Cardiac Surgery, Beijing An Zhen Hospital, Capital
Medical University, Beijing 100029, China
(Gao) Department of Cardiac Surgery, Beijing An Zhen Hospital, Capital
Medical University, Beijing 100029, China
(Yu) Department of Cardiac Surgery, Beijing An Zhen Hospital, Capital
Medical University, Beijing 100029, China
(Yu) Department of Cardiac Surgery, Beijing An Zhen Hospital, Capital
Medical University, Beijing 100029, China. Electronic address:
Title
Preoperative statin therapy is associated with reduced 30-day
postoperative all-cause mortality in patients undergoing coronary artery
bypass surgery: A meta-analysis of large size observational studies.
Source
International journal of cardiology. 181 (pp 11-13), 2015. Date of
Publication: 15 Feb 2015.

<14>
Accession Number
20160275680
Author
Lester-Coll N.H.; Rutter C.E.; Bledsoe T.J.; Goldberg S.B.; Decker R.H.;
Yu J.B.
Institution
(Lester-Coll, Rutter, Bledsoe, Decker, Yu) Department of Therapeutic
Radiology, Yale University School of Medicine, New Haven, CT, United
States
(Goldberg) Department of Medicine (Medical Oncology), Yale University
School of Medicine, New Haven, CT, United States
Title
Cost-effectiveness of surgery, stereotactic body radiation therapy, and
systemic therapy for pulmonary oligometastases.
Source
International Journal of Radiation Oncology Biology Physics. 95 (2) (pp
663-672), 2016. Date of Publication: 01 Jun 2016.
Publisher
Elsevier Inc.
Abstract
Introduction Pulmonary oligometastases have conventionally been managed
with surgery and/or systemic therapy. However, given concerns about the
high cost of systemic therapy and improvements in local treatment of
metastatic cancer, the optimal cost-effective management of these patients
is unclear. Therefore, we sought to assess the cost-effectiveness of
initial management strategies for pulmonary oligometastases. Methods and
Materials A cost-effectiveness analysis using a Markov modeling approach
was used to compare average cumulative costs, quality adjusted life years
(QALYs), and incremental cost-effectiveness ratios (ICERs) among 3 initial
disease management strategies: video-assisted thoracic surgery (VATS)
wedge resection, stereotactic body radiation therapy (SBRT), and systemic
therapy among 5 different cohorts of patient disease: (1) melanoma; (2)
non-small cell lung cancer adenocarcinoma without an EGFR mutation (NSCLC
AC); (3) NSCLC with an EGFR mutation (NSCLC EGFRm AC); (4) NSCLC squamous
cell carcinoma (NSCLC SCC); and (5) colon cancer. One-way sensitivity
analyses and probabilistic sensitivity analyses were performed to analyze
uncertainty with regard to model parameters. Results In the base case,
SBRT was cost effective for melanoma, with costs/net QALYs of
$467,787/0.85. In patients with NSCLC, the most cost-effective strategies
were SBRT for AC ($156,725/0.80), paclitaxel/carboplatin for SCC
($123,799/0.48), and erlotinib for EGFRm AC ($147,091/1.90). Stereotactic
body radiation therapy was marginally cost-effective for EGFRm AC compared
to erlotinib with an incremental cost-effectiveness ratio of
$126,303/QALY. For colon cancer, VATS wedge resection ($147,730/2.14) was
the most cost-effective strategy. Variables with the greatest influence in
the model were erlotinib-associated progression-free survival (EGFRm AC),
toxicity (EGFRm AC), cost of SBRT (NSCLC SCC), and patient utilities (all
histologies). Conclusions Video-assisted thoracic surgery wedge resection
or SBRT can be cost-effective in select patients with pulmonary
oligometastases, depending on histology, efficacy, and tolerability of
treatment and patient preferences.

<15>
Accession Number
20160221987
Author
Valdis M.; Chu M.W.A.; Schlachta C.; Kiaii B.
Institution
(Valdis, Chu, Kiaii) Division of Cardiac Surgery, Department of Surgery,
Western University, London Health Sciences Centre, 339 Windermere Rd,
London, ON N6A 5A5, Canada
(Schlachta) Division of General Surgery, Department of Surgery, Western
University, London Health Sciences Centre, London, ON, Canada
Title
Evaluation of robotic cardiac surgery simulation training: A randomized
controlled trial.
Source
Journal of Thoracic and Cardiovascular Surgery. 151 (6) (pp 1498-1505),
2016. Date of Publication: 01 Jun 2016.
Publisher
Mosby Inc.
Abstract
Objective To compare the currently available simulation training
modalities used to teach robotic surgery. Methods Forty surgical trainees
completed a standardized robotic 10-cm dissection of the internal thoracic
artery and placed 3 sutures of a mitral valve annuloplasty in porcine
models and were then randomized to a wet lab, a dry lab, a virtual reality
lab, or a control group that received no additional training. All groups
trained to a level of proficiency determined by 2 expert robotic cardiac
surgeons. All assessments were evaluated using the Global Evaluative
Assessment of Robotic Skills in a blinded fashion. Results Wet lab
trainees showed the greatest improvement in time-based scoring and the
objective scoring tool compared with the experts (mean, 24.9 +/- 1.7 vs
24.9 +/- 2.6; P =.704). The virtual reality lab improved their scores and
met the level of proficiency set by our experts for all primary outcomes
(mean, 24.9 +/- 1.7 vs 22.8 +/- 3.7; P =.103). Only the control group
trainees were not able to meet the expert level of proficiency for both
time-based scores and the objective scoring tool (mean, 24.9 +/- 1.7 vs
11.0 +/- 4.5; P <.001). The average duration of training was shortest for
the dry lab and longest for the virtual reality simulation (1.6 hours vs
9.3 hours; P <.001). Conclusions We have completed the first randomized
controlled trial to objectively compare the different training modalities
of robotic surgery. Our data demonstrate the significant benefits of wet
lab and virtual reality robotic simulation training and highlight key
differences in current training methods. This study can help guide
training programs in investing resources in cost-effective, high-yield
simulation exercises.

<16>
[Use Link to view the full text]
Accession Number
20160155119
Author
Lee E.-H.; Kim W.-J.; Kim J.-Y.; Chin J.-H.; Choi D.-K.; Sim J.-Y.; Choo
S.-J.; Chung C.-H.; Lee J.-W.; Choi I.-C.
Institution
(Lee, Kim, Kim, Chin, Choi, Sim, Choi) Department of Anesthesiology and
Pain Medicine, Asan Medical Center, University of Ulsan, 388-1, Pungnap
2-dong, Songpa-gu, Seoul 138-736, South Korea
(Choo, Chung, Lee) Department of Thoracic and Cardiovascular Surgery, Asan
Medical Center, University of Ulsan, Seoul, South Korea
Title
Effect of exogenous albumin on the incidence of postoperative acute kidney
injury in patients undergoing off-pump coronary artery bypass surgery with
a preoperative albumin level of less than 4.0 g/dl.
Source
Anesthesiology. 124 (5) (pp 1001-1011), 2016. Date of Publication: 01 May
2016.
Publisher
Lippincott Williams and Wilkins
Abstract
Background: Hypoalbuminemia may increase the risk of acute kidney injury
(AKI). The authors investigated whether the immediate preoperative
administration of 20% albumin solution affects the incidence of AKI after
off-pump coronary artery bypass surgery. Methods: In this prospective,
single-center, randomized, parallel-arm double-blind trial, 220 patients
with preoperative serum albumin levels less than 4.0 g/dl were
administered 100, 200, or 300 ml of 20% human albumin according to the
preoperative serum albumin level (3.5 to 3.9, 3.0 to 3.4, or less than 3.0
g/dl, respectively) or with an equal volume of saline before surgery. The
primary outcome measure was AKI incidence after surgery. Postoperative AKI
was defined by maximal AKI Network criteria based on creatinine changes.
Results: Patient characteristics and perioperative data except urine
output during surgery were similar between the two groups studied, the
albumin group and the control group. Urine output (median [interquartile
range]) during surgery was higher in the albumin group (550 ml [315 to
980]) than in the control group (370 ml [230 to 670]; P = 0.006). The
incidence of postoperative AKI in the albumin group was lower than that in
the control group (14 [13.7%] vs. 26 [25.7%]; P = 0.048). There were no
significant between-group differences in severe AKI, including renal
replacement therapy, 30-day mortality, and other clinical outcomes. There
were no significant adverse events. Conclusion: Administration of 20%
exogenous albumin immediately before surgery increases urine output during
surgery and reduces the risk of AKI after off-pump coronary artery bypass
surgery in patients with a preoperative serum albumin level of less than
4.0 g/dl.

<17>
Accession Number
2015480864
Author
Moglia A.; Ferrari V.; Morelli L.; Ferrari M.; Mosca F.; Cuschieri A.
Institution
(Moglia, Ferrari, Morelli, Ferrari) EndoCAS, Center for Computer Assisted
Surgery, University of Pisa, Edificio 102, via Paradisa 2, Pisa 56124,
Italy
(Ferrari) Information Engineering Department, University of Pisa, Pisa,
Italy
(Morelli) Multidisciplinary Center for Robotic Surgery, University
Hospital of Pisa, Pisa, Italy
(Mosca) Cisanello Teaching Hospital, Pisa, Italy
(Cuschieri) Scuola Superiore sant'Anna, Pisa, Italy
(Cuschieri) Institute for Medical Science and Technology, University of
Dundee, Dundee, United Kingdom
Title
A Systematic Review of Virtual Reality Simulators for Robot-assisted
Surgery.
Source
European Urology. 69 (6) (pp 1065-1080), 2016. Date of Publication: 01 Jun
2016.
Publisher
Elsevier
Abstract
Context No single large published randomized controlled trial (RCT) has
confirmed the efficacy of virtual simulators in the acquisition of skills
to the standard required for safe clinical robotic surgery. This remains
the main obstacle for the adoption of these virtual simulators in surgical
residency curricula. Objective To evaluate the level of evidence in
published studies on the efficacy of training on virtual simulators for
robotic surgery. Evidence acquisition In April 2015 a literature search
was conducted on PubMed, Web of Science, Scopus, Cochrane Library, the
Clinical Trials Database (US) and the Meta Register of Controlled Trials.
All publications were scrutinized for relevance to the review and for
assessment of the levels of evidence provided using the classification
developed by the Oxford Centre for Evidence-Based Medicine. Evidence
synthesis The publications included in the review consisted of one RCT and
28 cohort studies on validity, and seven RCTs and two cohort studies on
skills transfer from virtual simulators to robot-assisted surgery.
Simulators were rated good for realism (face validity) and for usefulness
as a training tool (content validity). However, the studies included used
various simulation training methodologies, limiting the assessment of
construct validity. The review confirms the absence of any consensus on
which tasks and metrics are the most effective for the da Vinci Skills
Simulator and dV-Trainer, the most widely investigated systems. Although
there is consensus for the RoSS simulator, this is based on only two
studies on construct validity involving four exercises. One study on
initial evaluation of an augmented reality module for partial nephrectomy
using the dV-Trainer reported high correlation (r = 0.8) between in vivo
porcine nephrectomy and a virtual renorrhaphy task according to the
overall Global Evaluation Assessment of Robotic Surgery (GEARS) score. In
one RCT on skills transfer, the experimental group outperformed the
control group, with a significant difference in overall GEARS score (p =
0.012) during performance of urethrovesical anastomosis on an inanimate
model. Only one study included assessment of a surgical procedure on real
patients: subjects trained on a virtual simulator outperformed the control
group following traditional training. However, besides the small numbers,
this study was not randomized. Conclusions There is an urgent need for a
large, well-designed, preferably multicenter RCT to study the efficacy of
virtual simulation for acquisition competence in and safe execution of
clinical robotic-assisted surgery. Patient summary We reviewed the
literature on virtual simulators for robot-assisted surgery. Validity
studies used various simulation training methodologies. It is not clear
which exercises and metrics are the most effective in distinguishing
different levels of experience on the da Vinci robot. There is no reported
evidence of skills transfer from simulation to clinical surgery on real
patients.

<18>
Accession Number
20160412617
Author
Du X.; Zhou C.; Huang B.; Ruan L.; Liang R.; Pan L.
Institution
(Du, Ruan, Liang, Pan) Department of Anesthesiology, Affiliated Tumor
Hospital of Guangxi Medical University, Nanning 530021, China
(Zhou, Huang) Intensive Care Unit, Affiliated Tumor Hospital of Guangxi
Medical University, Nanning 530021, China
Title
The effects of parecoxib sodium and flurbiprofen axetil injection on
postoperative shivering: A randomized, double-blinded clinical trial.
Source
International Journal of Clinical and Experimental Medicine. 9 (5) (pp
8543-8549), 2016. Date of Publication: 30 May 2016.
Publisher
E-Century Publishing Corporation (40 White Oaks Lane, Madison WI 53711,
United States)
Abstract
Objective: Postoperative shivering can cause patients serious adverse
events and influence their outcomes after general anesthesia. To date
there is no ideal drug which can be used to prevent post operative
shivering. The aim of this randomized controlled trial was to examine the
efficacy and accompanying side effects of prophylactic flurbiprofen along
with parecoxib or placebo for reducing postoperative shivering. Methods:
145 patients with American Society of Anesthesiologists physical status
I-II, who were scheduled for colorectal surgery under general anesthesia
were selected. Subjects were randomly assigned to receive flurbiprofen 50
mg (Group F), parecoxib sodium 40 mg (Group P) or normal saline (Group S)
40 minutes before the end of surgery. Heart rate and mean blood pressure
were recorded. The occurrence of shivering, visual analogue score (VAS),
ramsy sedation scale (RSS), postoperative nausea and vomiting were
recorded an hour after extubation. Results: The incidence and severity of
postoperative shivering were significantly lower in Groups P (18.75%) and
F (20.41%) than in Group S (50%, P<0.01). The visual analogue score was
significantly lower in Groups P and F than in Group S at the time of
extubation, 30 minutes after extubation and 60 minutes after extubation
(P<0.01). There was no significant difference between Groups P and F.
Compared to Group S, there were no significant difference in the sedation
scores and the incidence of postoperative nausea and vomiting in Groups P
and F. Conclusions: Intraoperative intravenous administration of
flurbiprofen (50 mg) or parecoxib sodium (40 mg) is effective in
decreasing the incidence and severity of postoperative shivering in
patients undergoing colorectal surgery under general anesthesia, and does
not pose significant risk of side effects.

<19>
Accession Number
20160405145
Author
Chen T.; Wang K.; Xu J.; Ma W.; Zhou J.
Institution
(Chen, Wang, Xu, Zhou) Department of Cardiothoracic Surgery, Shuguang
Hospital Affiliated to the Shanghai University of Traditional Chinese
Medicine, Shanghai 201203, China
(Ma) Department of Acu-Moxibustion, Shuguang Hospital Affiliated to the
Shanghai University of Traditional Chinese Medicine, Shanghai 201203,
China
Title
Electroacupuncture Reduces Postoperative Pain and Analgesic Consumption in
Patients Undergoing Thoracic Surgery: A Randomized Study.
Source
Evidence-based Complementary and Alternative Medicine. 2016 (no
pagination), 2016. Article Number: 2126416. Date of Publication: 2016.
Publisher
Hindawi Publishing Corporation (410 Park Avenue, 15th Floor, 287 pmb, New
York NY 10022, United States)
Abstract
The aim of this study was to evaluate the effect of electroacupuncture
(EA) on postoperative pain management in patients undergoing thoracic
surgery. A randomized study was conducted. Ninety-two thoracic surgical
patients were randomly divided into an EA group and a sham group.
Postoperative intravenous analgesia was applied with a half dose of the
conventional drug concentration in both groups. In the EA group, EA
treatment was administered for three consecutive days after the surgery
with 6 sessions of 30 min each. Compared with the sham group, patients in
the EA group had a lower visual analogue scale (VAS) score at 2, 24, 48,
and 72 hours and consumed less analgesic after surgery. The incidence of
opioid-related adverse effects of nausea was lower in the EA group. The
time to first flatus and defecation was also shorter in the EA group.
Furthermore, the plasma beta-endorphin (beta-EP) level was higher by
radioimmunoassay and the plasma 5-hydroxytryptamine (5-HT) level was lower
in the EA group by enzyme-linked immunosorbent assay during the first 72
hr after thoracic surgery. Therefore, EA is suitable as an adjunct
treatment for postoperative pain management after thoracic surgery.

<20>
Accession Number
2015316711
Author
AlJaroudi W.; Campagnoli T.; Fughhi I.; Wassouf M.; Ali A.; Doukky R.
Institution
(AlJaroudi) Division of Cardiovascular Medicine, Clemenceau Medical
Center, Beirut, Lebanon
(Campagnoli, Fughhi, Wassouf, Doukky) Division of Cardiology, Rush
University Medical Center, Chicago, IL, United States
(Ali) Department of Radiology and Nuclear Medicine, Rush University
Medical Center, Chicago, IL, United States
(Doukky) Division of Cardiology, John H. Stroger Jr. Hospital of Cook
County, 1901 W. Harrison St., Suite # 3620, Chicago, IL 60612, United
States
Title
Prognostic value of heart rate response during regadenoson stress
myocardial perfusion imaging in patients with end stage renal disease.
Source
Journal of Nuclear Cardiology. 23 (3) (pp 560-569), 2016. Date of
Publication: 01 Jun 2016.
Publisher
Springer New York LLC
Abstract
Background: Blunted heart rate response (HRR) to vasodilator stress agents
is associated with worse outcomes. There are limited data assessing the
effect of impaired HRR to regadenoson among patients with end-stage renal
disease (ESRD) undergoing stress myocardial perfusion imaging (MPI).
Methods: We prospectively followed patients with ESRD enrolled in the
ASSUAGE and ASSUAGE-CKD trials. HRR was defined as 100*(peak stress heart
rate-resting heart rate)/resting heart rate. Study cohort was dichotomized
to blunted and normal HRR groups according to an established median HRR
value <28% or >28%, which were propensity-score matched based on 22
clinical and imaging covariates. The Primary endpoint was all-cause death.
The secondary cardiac-specific endpoints included: (1) the composite
endpoint of cardiac death or myocardial infarction; (2) the composite
endpoint of cardiac death, myocardial infarction, or late (>90 days)
coronary revascularization. Results: There were 303 patients followed for
35 +/- 10 months. In the entire cohort, there was a stepwise increase in
the rates of death and all secondary endpoints with worsening HRR (P
values <.001). Blunted HRR (<28%) was associated with increased risk of
death (unadjusted hazard ratio 4.10 [1.98-8.46], P < .001) and all
secondary endpoints (P < .001). After multivariate adjustment, HRR
remained an independent predictor of mortality and secondary endpoints
whether used as continuous or dichotomous variable, and added incremental
prognostic value for all-cause death (P = .046). Blunted HRR was
associated with increased event rate among patients with normal myocardial
perfusion (P = .001) and abnormal perfusion (P = .053). In the
propensity-matched cohort of 132 patients (66 in each group), blunted HRR
was associated with significant increase in all-cause death (21% vs. 5%,
HR 5.09 [1.46-17.7], P=.011), and similarly for the secondary endpoints.
Conclusion: Blunted HRR (<28%) to regadenoson is a strong and independent
predictor of death and cardiovascular events in patients with ESRD and
adds incremental prognostic value.

<21>
Accession Number
20160415484
Author
Kogler J.; Peric M.; Hrabac P.; Bekavac-Misak V.; Karaman-Ilic M.
Institution
(Kogler, Peric, Bekavac-Misak) Department of Anesthesiology, Reanimatology
and Intensive Care, Zagreb University Hospital Centre, Zagreb, Croatia
(Hrabac) University of Zagreb School of medicine, Croatian Institute for
Brain Research, Zagreb, Croatia
(Karaman-Ilic) Department of Anesthesiology, Reanimatology and Intensive
care, Clinical Hospital "Sveti Duh", Zagreb, Croatia
Title
Effects of epidural magnesium sulphate on intraoperative sufentanil and
postoperative analgesic requirements in thoracic surgery patients.
Source
Signa Vitae. 11 (1) (pp 56-73), 2016. Date of Publication: 2016.
Publisher
Pharmamed Mado Ltd. (Zatisje 8 g, Zagreb 10000, Croatia. E-mail:
marija.karamarko@pharmamed.com)
Abstract
Introduction. Thoracic surgery is associated with high levels of pain.
Magnesium has antinociceptive effects in animal and human models of pain.
Objectives. The aim of this randomized prospective study was to assess the
effects of continuous epidural magnesium infusion during thoracic surgery
on intraoperative sufentanil consumption and postoperative analgesic
requirements during the first 48 hours after surgery. Materials and
methods. Seventy patients were randomized into two groups of 35 patients:
Group 1 (magnesium group) received an epidural with 10% magnesium sulfate
(MgSO<inf>4</inf>) along with anesthetic drugs (midazolam, propofol,
rocuronium, sufentanil, levobupivacain), and group 2 (control group)
received an epidural with 0.9% sodium chloride (NaCl) solution along with
anesthetic drugs intraoperatively. Postoperatively, group 1 patients were
administered the 10% magnesium sulfate epidural in addition to a local
anesthetic and opioid, whereas group 2 patients were administered the
local anesthetic and opioid alone. Primary outcomes of the study were to
determine the cumulative doses of intraoperatively administered sufentanil
and cumulative doses of sufentanil and levobupivacaine administered during
the first 48 h postoperatively. Secondary outcomes were a visual analog
scale (VAS) score for rest and movement every 4 hours, level of sedation,
cardiovascular, respiratory and neurological complications, incidence of
postoperative shivering, nausea and vomiting and global patient
satisfaction. Results. The cumulative sufentanil dose required
intraoperatively was significantly lower in the magnesium group: 43.00 mug
vs 56.3 mug (p = 0.001). VAS scores measured every 4 hours at rest and
movement during the first 48 hours postoperatively, cumulative analgesic
consumption, incidence of shivering, nausea and vomiting were
significantly lower in the magnesium group. The global satisfaction score
was significantly higher in the magnesium group (4.3 vs 3.7; p = 0.005).
Conclusion. The addition of magnesium in the epidural mixture of
sufentanil and levobupivacaine led to more efficient intraoperative and
postoperative analgesia, lower sufentanil and levobupivacaine consumption,
lower incidence of postoperative shivering, nausea and vomiting. Epidural
with magnesium appears to be a useful adjunct to anesthetic drugs, which
can exert positive effects on the course and outcome of thoracic surgery
patients.

<22>
Accession Number
20160432635
Author
Papachristofi O.; Jenkins D.; Sharples L.D.
Institution
(Papachristofi) MRC Biostatistics Unit, Robinson Way CB4 3EU, Cambridge,
United Kingdom
(Papachristofi, Sharples) University of Leeds, Comprehensive Health
Research Division, Leeds Institute of Clinical Trials Research, 71-75
Clarendon Road, Leeds LS2 9PH, United Kingdom
(Jenkins) Departments of Surgery, Anaesthesia and Clinical Audit, Papworth
Hospital, CB23 8RE, Cambridge, United Kingdom
Title
Assessment of learning curves in complex surgical interventions: A
consecutive case-series study.
Source
Trials. 17 (1) (no pagination), 2016. Article Number: 266. Date of
Publication: 01 Jun 2016.
Publisher
BioMed Central Ltd.
Abstract
Background: Surgical interventions are complex, which complicates their
rigorous assessment through randomised clinical trials. An important
component of complexity relates to surgeon experience and the rate at
which the required level of skill is achieved, known as the learning
curve. There is considerable evidence that operator performance for
surgical innovations will change with increasing experience. Such learning
effects complicate evaluations; the start of the trial might be delayed,
resulting in loss of surgeon equipoise or, if an assessment is undertaken
before performance has stabilised, the true impact of the intervention may
be distorted. Methods: Formal estimation of learning parameters is
necessary to characterise the learning curve, model its evolution and
adjust for its presence during assessment. Current methods are either
descriptive or model the learning curve through three main features: the
initial skill level, the learning rate and the final skill level achieved.
We introduce a fourth characterising feature, the duration of the learning
period, which provides an estimate of the point at which learning has
stabilised. We propose a two-phase model to estimate formally all four
learning curve features. Results: We demonstrate that the two-phase model
can be used to estimate the end of the learning period by incorporating a
parameter for estimating the duration of learning. This is achieved by
breaking down the model into a phase describing the learning period and
one describing cases after the final skill level is reached, with the
break point representing the length of learning. We illustrate the method
using cardiac surgery data. Conclusions: This modelling extension is
useful as it provides a measure of the potential cost of learning an
intervention and enables statisticians to accommodate cases undertaken
during the learning phase and assess the intervention after the optimal
skill level is reached. The limitations of the method and implications for
the optimal timing of a definitive randomised controlled trial are also
discussed.

<23>
Accession Number
20160406749
Author
Holcomb C.N.; Hollis R.H.; Graham L.A.; Richman J.S.; Valle J.A.; Itani
K.M.; Maddox T.M.; Hawn M.T.
Institution
(Holcomb, Hollis, Graham, Richman) Department of Surgery, University of
Alabama at Birmingham, United States
(Holcomb, Hollis, Graham, Richman) Center for Surgical, Medical Acute Care
Research and Transitions (C-SMART), Birmingham VA Hospital, Birmingham,
AL, United States
(Valle, Maddox) VA Eastern Colorado Health Care System, Denver, United
States
(Valle, Maddox) University of Colorado School of Medicine, Denver, United
States
(Itani) Department of Surgery, VA Boston Healthcare System, Boston
University and Harvard Medical School, Boston, MA, United States
(Hawn) Department of Surgery, Stanford School of Medicine, 300 Pasteur Dr,
M121 Always, Stanford, CA 94305, United States
Title
Association of coronary stent indication with postoperative outcomes
following noncardiac surgery.
Source
JAMA Surgery. 151 (5) (pp 462-469), 2016. Date of Publication: May 2016.
Publisher
American Medical Association
Abstract
IMPORTANCE: Current guidelines for delaying surgery after coronary stent
placement are based on stent type. However, the indication for the stent
may be an important risk factor for postoperative major adverse cardiac
events (MACE). OBJECTIVE: To determine whether the clinical indication for
a coronary stent is associated with postoperativeMACE. DESIGN, SETTING,
AND PARTICIPANTS: Retrospective cohort study in patients at US Veterans
Affairs hospitals who had a coronary stent placed between January 1, 2000,
and December 31, 2010, and underwent noncardiac surgery within the
following 24 months. The association between the indication for stent and
postoperativeMACE rates was examined using logistic regression to control
for patient and procedure factors. EXPOSURES: Three subgroups of stent
indication were examined: (1)myocardial infarction (MI); (2) unstable
angina; and (3) revascularization not associated with acute coronary
syndrome (non-ACS). MAIN OUTCOMES AND MEASURES: Composite 30-day
postoperativeMACE rates including all-cause mortality, MI, or
revascularization. RESULTS: Among 26 661 patients (median [IQR] age, 68
[61.0-76.0] years; 98.4%male; 88.1%white) who underwent 41 815 surgical
procedures within 24 months following coronary stent placement, the stent
indication wasMI in 32.8%of the procedures, unstable angina in 33.8%, and
non-ACS in 33.4%. PostoperativeMACE rates were significantly higher in the
MI group (7.5%) compared with the unstable angina (2.7%) and non-ACS
(2.6%) groups (P < .001). When surgery was performed within 3 months of
percutaneous coronary intervention, adjusted odds of MACE were
significantly higher in the MI group compared with the non-ACS group (odds
ratio [OR] = 5.25; 95%CI, 4.08-6.75). This risk decreased over time,
although it remained significantly higher at 12 to 24 months from
percutaneous coronary intervention (OR = 1.95; 95%CI, 1.58-2.40). The
adjusted odds of MACE for the unstable angina group were similar to those
for the non-ACS group when surgery was performed within 3 months (OR =
1.11; 95%CI, 0.80-1.53) or between 12 and 24 months (OR = 1.08; 95% CI,
0.86-1.37) from stent placement. Stent type was not significantly
associated with MACE regardless of indication. CONCLUSIONS AND RELEVANCE:
Surgery in patients with a coronary stent placed forMI was associated with
increased postoperativeMACE rates compared with other stent indications.
The risk declined over time from PCI, and delaying surgery up to 6 months
in this cohort of patients with stents may be important regardless of
stent type.

<24>
Accession Number
20160401891
Author
Dyakova M.; Shantikumar S.; Colquitt J.L.; Drew C.M.; Sime M.; Maciver J.;
Wright N.; Clarke A.; Rees K.
Institution
(Dyakova, Shantikumar, Drew, Sime, Maciver, Clarke, Rees) Warwick Medical
School, University of Warwick, Division of Health Sciences, Gibbet Hill
Campus, Coventry, Warwickshire CV4 7AL, United Kingdom
(Colquitt) Effective Evidence LLP, 7 Bournemouth Road, Chandlers Ford,
Eastleigh, Hampshire SO53 3DA, United Kingdom
(Wright) NHS Warwickshire, Public Health Department, Warwick, United
Kingdom
Title
Systematic versus opportunistic risk assessment for the primary prevention
of cardiovascular disease.
Source
Cochrane Database of Systematic Reviews. 2016 (2) (no pagination), 2016.
Article Number: CD010411. Date of Publication: 29 Jan 2016.
Publisher
John Wiley and Sons Ltd (Southern Gate, Chichester, West Sussex PO19 8SQ,
United Kingdom)
Abstract
Background: Screening programmes can potentially identify people at high
cardiovascular risk and reduce cardiovascular disease (CVD) morbidity and
mortality. However, there is currently not enough evidence showing clear
clinical or economic benefits of systematic screening-like programmes over
the widely practised opportunistic risk assessment of CVD in primary care
settings. Objectives: The primary objective of this review was to assess
the effectiveness, costs and adverse effects of systematic risk assessment
compared to opportunistic risk assessment for the primary prevention of
CVD. Search methods: We searched the Cochrane Central Register of
Controlled Trials (CENTRAL) on the Cochrane Library, MEDLINE, EMBASE on 30
January 2015, and Web of Science Core Collection and additional databases
on the Cochrane Library on 4 December 2014. We also searched two clinical
trial registers and checked reference lists of relevant articles. We
applied no language restrictions. Selection criteria: We selected
randomised controlled trials (RCTs) that assessed the effects of
systematic risk assessment, defined as a screening-like programme
involving a predetermined selection process of people, compared with
opportunistic risk assessment which ranged from no risk assessment at all
to incentivised case finding of CVD and related risk factors. Participants
included healthy adults from the general population, including those who
are at risk of CVD. Data collection and analysis: Two review authors
independently selected studies. One review author extracted data and
assessed them for risk of bias and a second checked them. We assessed
evidence quality using the GRADE approach and present this in a 'Summary
of findings' table. Main results: Nine completed RCTs met the inclusion
criteria, of which four were cluster-randomised. We also identified five
ongoing trials. The included studies had a high or unclear risk of bias,
and the GRADE ratings of overall quality were low or very low. The length
of follow-up varied from one year in four studies, three years in one
study, five or six years in two studies, and ten years in two studies.
Eight studies recruited participants from the general population, although
there were differences in the age ranges targeted. One study recruited
family members of cardiac patients (high risk assessment). There were
considerable differences between the studies in the interventions received
by the intervention and control groups. There was insufficient evidence to
stratify by the types of risk assessment approaches. Limited data were
available on all-cause mortality (risk ratio (RR) 0.97, 95% confidence
interval (CI) 0.92 to 1.02; 3 studies,103,571 participants, I2 = 0%;
low-quality evidence) and cardiovascular mortality (RR 1.00, 95% CI 0.90
to 1.11; 2 studies, 43,955 participants, I2 = 0%), and suggest that
screening has no effect on these outcomes. Data were also limited for
combined non-fatal endpoints; overall, evidence indicates no difference in
total coronary heart disease (RR 1.01, 95% CI 0.95 to 1.07; 4 studies, 5
comparisons, 110,168 participants, I2 = 0%; low-quality evidence),
non-fatal coronary heart disease (RR 0.98, 95% CI 0.89 to 1.09; 2 studies,
43,955 participants, I2 = 39%), total stroke (RR 0.99, 95% CI 0.90 to
1.10; 2 studies, 79,631 participants, I2 = 0%, low-quality evidence), and
non-fatal stroke (RR 1.17, 95% CI 0.94 to 1.47; 1 study, 20,015
participants). Overall, systematic risk assessment appears to result in
lower total cholesterol levels (mean difference (MD) -0.11 mmol/l, 95% CI
-0.17 to -0.04, 6 studies, 7 comparisons, 12,591 participants, I2 = 57%;
very low-quality evidence), lower systolic blood pressure (MD -3.05 mmHg,
95% CI -4.84 to -1.25, 6 studies, 7 comparisons, 12,591 participants, I2 =
82%; very low-quality evidence) and lower diastolic blood pressure (MD
-1.34 mmHg, 95% CI -1.76 to -0.93, 6 studies, 7 comparisons, 12,591
participants, I2 = 0%; low-quality evidence). One study assessed adverse
effects and found no difference in psychological distress at five years
(1126 participants). Authors' conclusions: The results are limited by the
heterogeneity between trials in terms of participants recruited,
interventions and duration of follow-up. Limited data suggest that
systematic risk assessment for CVD has no statistically significant
effects on clinical endpoints. There is limited evidence to suggest that
CVD systematic risk assessment may have some favourable effects on
cardiovascular risk factors. The completion of the five ongoing trials
will add to the evidence base.

<25>
Accession Number
20160401704
Author
Zou Z.; Yuan H.B.; Yang B.; Xu F.; Chen X.Y.; Liu G.J.; Shi X.Y.
Institution
(Zou, Yuan, Xu, Shi) Changzheng Hospital, The Second Military Medical
University, Department of Anaesthesiology, Shanghai, No 415, Feng Yang
Road, Shanghai 200003, China
(Yang) Changzheng Hospital, Second Military Medical University, Kidney
Institute of CPLA, Division of Nephrology, 415 Fengyang Road, Shanghai
200003, China
(Chen) The General Hospital of the People's Liberation Army (PLAGH), also
Hospital 301, Department of Neurology, Beijing, No. 28, Fuxing Road,
Beijing 100853, China
(Liu) West China Hospital, Sichuan University, Chinese Cochrane Centre,
Chinese Evidence-Based Medicine Centre, No. 37, Guo Xue Xiang, Chengdu,
Sichuan 610041, China
(Shi) Xinhua Hospital, Shanghai Jiaotong University, School of Medicine,
Department of Anesthesiology and SICU, No 1665, Kongjiang Road, Shanghai
200092, China
Title
Perioperative angiotensin-converting enzyme inhibitors or angiotensin II
type 1 receptor blockers for preventing mortality and morbidity in adults.
Source
Cochrane Database of Systematic Reviews. 2016 (1) (no pagination), 2016.
Article Number: CD009210. Date of Publication: 27 Jan 2016.
Publisher
John Wiley and Sons Ltd (Southern Gate, Chichester, West Sussex PO19 8SQ,
United Kingdom)
Abstract
Background: Perioperative hypertension requires careful management.
Angiotensin-converting enzyme inhibitors (ACEIs) or angiotensin II type 1
receptor blockers (ARBs) have shown efficacy in treating hypertension
associated with surgery. However, there is lack of consensus about whether
they can prevent mortality and morbidity. Objectives: To systematically
assess the benefits and harms of administration of ACEIs or ARBs
perioperatively for the prevention of mortality and morbidity in adults
(aged 18 years and above) undergoing any type of surgery under general
anaesthesia. Search methods: We searched the current issue of the Cochrane
Central Register of Controlled Trials (CENTRAL; 2014, Issue 12), Ovid
MEDLINE (1966 to 8 December 2014), EMBASE (1980 to 8 December 2014), and
references of the retrieved randomized trials, meta-analyses, and
systematic reviews. Selection criteria: We included randomized controlled
trials (RCTs) comparing perioperative administration of ACEIs or ARBs with
placebo in adults (aged 18 years and above) undergoing any type of surgery
under general anaesthesia. We excluded studies in which participants
underwent procedures that required local anaesthesia only, or participants
who had already been on ACEIs or ARBs. Data collection and analysis: Two
review authors independently performed study selection, assessed the risk
of bias, and extracted data. We used standard methodological procedures
expected by Cochrane. Main results: We included seven RCTs with a total of
571 participants in the review. Two of the seven trials involved 36
participants undergoing non-cardiac vascular surgery (infrarenal aortic
surgery), and five involved 535 participants undergoing cardiac surgery,
including valvular surgery, coronary artery bypass surgery, and
cardiopulmonary bypass surgery. The intervention was started from 11 days
to 25 minutes before surgery in six trials and during surgery in one
trial. We considered all seven RCTs to carry a high risk of bias. The
effects of ACEIs or ARBs on perioperative mortality and acute myocardial
infarction were uncertain because the quality of the evidence was very
low. The risk of death was 2.7% in the ACEIs or ARBs group and 1.6% in the
placebo group (risk ratio (RR) 1.61; 95% confidence interval (CI) 0.44 to
5.85). The risk of acute myocardial infarction was 1.7% in the ACEIs or
ARBs group and 3.0% in the placebo group (RR 0.55; 95% CI 0.14 to 2.26).
ACEIs or ARBs may improve congestive heart failure (cardiac index)
perioperatively (mean difference (MD) -0.60; 95% CI -0.70 to -0.50, very
low-quality evidence). In terms of rate of complications, there was no
difference in perioperative cerebrovascular complications (RR 0.48; 95% CI
0.18 to 1.28, very low-quality evidence) and hypotension (RR 1.95; 95% CI
0.86 to 4.41, very low-quality evidence). Cardiac surgery-related renal
failure was not reported. ACEIs or ARBs were associated with shortened
length of hospital stay (MD -0.54; 95% CI -0.93 to -0.16, P value = 0.005,
very low-quality evidence). These findings should be interpreted
cautiously due to likely confounding by the clinical backgrounds of the
participants. ACEIs or ARBs may shorten the length of hospital stay, (MD
-0.54; 95% CI -0.93 to -0.16, very low-quality evidence) Two studies
reported adverse events, and there was no evidence of a difference between
the ACEIs or ARBs and control groups. Authors' conclusions: Overall, this
review did not find evidence to support that perioperative ACEIs or ARBs
can prevent mortality, morbidity, and complications (hypotension,
perioperative cerebrovascular complications, and cardiac surgery-related
renal failure). We found no evidence showing that the use of these drugs
may reduce the rate of acute myocardial infarction. However, ACEIs or ARBs
may increase cardiac output perioperatively. Due to the low and very low
methodology quality, high risk of bias, and lack of power of the included
studies, the true effect may be substantially different from the observed
estimates. Perioperative (mainly elective cardiac surgery, according to
included studies) initiation of ACEIs or ARBs therapy should be
individualized.

<26>
Accession Number
20160270490
Author
Kelbaek H.; Hofsten D.E.; Kober L.; Helqvist S.; Klovgaard L.; Holmvang
L.; Jorgensen E.; Pedersen F.; Saunamaki K.; De Backer O.; Bang L.E.;
Kofoed K.F.; Lonborg J.; Ahtarovski K.; Vejlstrup N.; Botker H.E.;
Terkelsen C.J.; Christiansen E.H.; Ravkilde J.; Tilsted H.-H.; Villadsen
A.B.; Aaroe J.; Jensen S.E.; Raungaard B.; Jensen L.O.; Clemmensen P.;
Grande P.; Madsen J.K.; Torp-Pedersen C.; Engstrom T.
Institution
(Kelbaek) Department of Cardiology, Roskilde Hospital, Roskilde 4000,
Denmark
(Hofsten, Kober, Helqvist, Klovgaard, Holmvang, Jorgensen, Pedersen,
Saunamaki, De Backer, Bang, Kofoed, Lonborg, Ahtarovski, Vejlstrup,
Engstrom) Department of Cardiology, Rigshospitalet, University of
Copenhagen, Copenhagen, Denmark
(Madsen, Torp-Pedersen) Department of Cardiology, Gentofte Hospital,
University of Copenhagen, Copenhagen, Denmark
(Botker, Terkelsen, Christiansen) Department of Cardiology, Skejby
Hospital, University of Aarhus, Aarhus, Denmark
(Ravkilde, Tilsted, Villadsen, Aaroe, Jensen, Raungaard) Department of
Cardiology, Aalborg University Hospital, Aalborg, Denmark
(Jensen) Department of Cardiology, Odense Hospital, University of Odense,
Odense, Denmark
(Clemmensen, Grande) Department of Cardiology, Nykobing Falster Hospital,
Denmark
Title
Deferred versus conventional stent implantation in patients with
ST-segment elevation myocardial infarction (DANAMI 3-DEFER): An
open-label, randomised controlled trial.
Source
The Lancet. 387 (10034) (pp 2199-2206), 2016. Date of Publication: 28 May
2016.
Publisher
Lancet Publishing Group
Abstract
Background Despite successful treatment of the culprit artery lesion by
primary percutaneous coronary intervention (PCI) with stent implantation,
thrombotic embolisation occurs in some cases, which impairs the prognosis
of patients with ST-segment elevation myocardial infarction (STEMI). We
aimed to assess the clinical outcomes of deferred stent implantation
versus standard PCI in patients with STEMI. Methods We did this
open-label, randomised controlled trial at four primary PCI centres in
Denmark. Eligible patients (aged >18 years) had acute onset symptoms
lasting 12 h or less, and ST-segment elevation of 0.1 mV or more in at
least two or more contiguous electrocardiographic leads or newly developed
left bundle branch block. Patients were randomly assigned (1:1), via an
electronic web-based system with permuted block sizes of two to six, to
receive either standard primary PCI with immediate stent implantation or
deferred stent implantation 48 h after the index procedure if a stabilised
flow could be obtained in the infarct-related artery. The primary endpoint
was a composite of all-cause mortality, hospital admission for heart
failure, recurrent infarction, and any unplanned revascularisation of the
target vessel within 2 years' follow-up. Patients, investigators, and
treating clinicians were not masked to treatment allocation. We did
analysis by intention to treat. This trial is registered with
ClinicalTrials.gov, number NCT01435408. Findings Between March 1, 2011,
and Feb 28, 2014, we randomly assigned 1215 patients to receive either
standard PCI (n=612) or deferred stent implantation (n=603). Median
follow-up time was 42 months (IQR 33-49). Events comprising the primary
endpoint occurred in 109 (18%) patients who had standard PCI and in 105
(17%) patients who had deferred stent implantation (hazard ratio 0.99, 95%
CI 0.76-1.29; p=0.92). Procedure-related myocardial infarction, bleeding
requiring transfusion or surgery, contrast-induced nephopathy, or stroke
occurred in 28 (5%) patients in the conventional PCI group versus 27 (4%)
patients in the deferred stent implantation group, with no significant
differences between groups. Interpretation In patients with STEMI, routine
deferred stent implantation did not reduce the occurrence of death, heart
failure, myocardial infarction, or repeat revascularisation compared with
conventional PCI. Results from ongoing randomised trials might shed
further light on the concept of deferred stenting in this patient
population. Funding Danish Agency for Science, Technology and Innovation,
and Danish Council for Strategic Research.

<27>
[Use Link to view the full text]
Accession Number
20160195184
Author
Bai S.; Fu X.; Gu X.; Wang Y.; Li W.; Fan Y.; Wei L.; Bi X.
Institution
(Bai, Fu, Gu, Wang, Li, Fan, Wei, Bi) Department of Cardiology, Second
Hospital of Hebei Medical University, No 215 Heping West Road,
Shijiazhuang, Hebei 050000, China
Title
Intracoronary administration of different doses of anisodamine in primary
percutaneous coronary intervention: Protective effect in patients with
ST-segment elevation myocardial infarction.
Source
Coronary Artery Disease. 27 (4) (pp 302-310), 2016. Date of Publication:
2016.
Publisher
Lippincott Williams and Wilkins
Abstract
Objective: The aim of this study was to evaluate the effects of
intracoronary administration of anisodamine on myocardial reperfusion in
patients with ST-segment elevation myocardial infarction (STEMI)
undergoing a primary percutaneous coronary intervention (pPCI). Methods:
Patients with acute STEMI undergoing pPCI were enrolled in this
randomized-controlled study (January 2014-June 2015) and divided randomly
into four groups: group A (normal saline), group B (1000 mug anisodamine),
group C (2000 mug anisodamine), and group D (4000 mug anisodamine).
Results: The study group included 140 patients. Percentages of
thrombolysis in myocardial infarction (TIMI) myocardial perfusion grade 3,
increased values of TIMI myocardial perfusion grade after stenting, and
decreased values of corrected TIMI frame count in groups B, C, and D were
all significantly higher than those in group A (P=0.031, 0.027, 0.003, and
P<0.001, respectively). TIMI frame count after stenting in groups B, C,
and D was significantly lower than that in group A (P=0.001). Left
ventricular ejection fraction at 1 week after pPCI and at the 3-month
follow-up, as well as the major adverse cardiac event-free survival rate
in groups B, C, and D were higher than those in group A (P=0.027, 0.016,
and 0.019, respectively). Conclusion: Intracoronary administration of
anisodamine at different doses improved myocardial reperfusion in patients
with STEMI undergoing pPCI and reduced major adverse cardiac events. The
protective effect of anisodamine at a dose of 4000 mug might be better
than the doses at 1000 and 2000 mug.

<28>
[Use Link to view the full text]
Accession Number
20151056766
Author
Usmiani T.; Andreis A.; Budano C.; Sbarra P.; Andriani M.; Garrone P.;
Fanelli A.L.; Calcagnile C.; Bergamasco L.; Biancone L.; Marra S.
Institution
(Usmiani, Andreis, Budano, Sbarra, Andriani, Garrone, Fanelli, Calcagnile,
Marra) Cardiovascular and Thoracic Department, A.O.U. Citta della Salute e
della Scienza di Torino-Molinette, Corso Bramante 88, Turin 10126, Italy
(Bergamasco) Department of Surgical Sciences, University of Torino, Turin,
Italy
(Biancone) Nephrology Department, A.O.U. Citta della Salute e della
Scienza di Torino-Molinette, Turin, Italy
Title
AKIGUARD (Acute Kidney Injury GUARding Device) trial: In-hospital and
one-year outcomes.
Source
Journal of Cardiovascular Medicine. 17 (7) (pp 530-537), 2016. Date of
Publication: 01 Jul 2016.
Publisher
Lippincott Williams and Wilkins
Abstract
Aims: Contrast-induced acute kidney injury (CIAKI) in patients with
chronic kidney disease undergoing coronary angiography or percutaneous
coronary intervention is a common iatrogenic complication associated with
increased morbidity and mortality. This study compares sodium
bicarbonate/isotonic saline/N-acetylcysteine/vitamin C prophylaxis
(BS-NAC) against high-volume forced diuresis with matched hydration in
CIAKI prevention. Methods: One-hundred and thirty-three consecutive
patients undergoing coronary angiography or percutaneous coronary
intervention with estimated glomerular filtration rate less than 60
mL/min/1.73m² were randomized to the study group receiving
matched hydration (MHG) or to the control group receiving BS-NAC. MHG
received in vein (i.v.) 250 mL isotonic saline bolus, followed by a 0.5
mg/kg furosemide i.v. bolus to forced diuresis. A dedicated device
automatically matched the isotonic saline i.v. infusion rate to the
urinary output for 1 h before, during and 4 h after the procedure.
Results: MHG had the lowest incidence of CIAKI (7 vs. 25%, P = 0.01),
major adverse cardiac and cerebrovascular events at 1 year (7 vs. 32%, P <
0.01) and readmissions to cardiology/nephrology departments (8 vs. 25%, P
= 0.03; hospitalization days 1.0 +/- 3.8 vs. 4.9 +/- 12.5, P = 0.01).
Three months after the procedure the decrease in the estimated glomerular
filtration rate was 0.02% for MHG versus 15% for the control group.
Conclusion: Matched hydration was more effective than BS-NAC in CIAKI
prevention. One-year follow-up showed that matched hydration was
associated also with limited chronic kidney disease progression, major
adverse cardiac and cerebrovascular events and hospitalizations.

<29>
Accession Number
20160155060
Author
Duraes A.R.; de Souza Roriz P.; de Almeida Nunes B.; Albuquerque F.P.; de
Bulhoes F.V.; de Souza Fernandes A.M.; Aras R.
Institution
(Duraes, de Souza Roriz, de Almeida Nunes, Albuquerque, de Bulhoes, de
Souza Fernandes, Aras) Hospital Ana Nery/UFBa, Rua Saldanha Marinho, S/N,
Caixa D'Agua, Salvador, Brazil
Title
Dabigatran Versus Warfarin After Bioprosthesis Valve Replacement for the
Management of Atrial Fibrillation Postoperatively: DAWA Pilot Study.
Source
Drugs in R and D. 16 (2) (pp 149-154), 2016. Date of Publication: 01 Jun
2016.
Publisher
Springer International Publishing
Abstract
Objectives: Dabigatran is a direct thrombin inhibitor shown to be an
effective alternative to warfarin in patients with non-valvular atrial
fibrillation (AF). We evaluated the use of dabigatran in patients with
bioprosthetic mitral and/or aortic valve replacement and AF. Methods: We
selected 34 and randomized 27 patients in a 1:1 ratio to receive
dabigatran or warfarin. The primary endpoint was the presence of a new
intracardiac thrombus at 90 days, by transesophageal echocardiogram (TEE).
Secondary endpoints included the development of dense spontaneous echo
contrast (SEC) and incidence of stroke (ischemic or hemorrhagic),
myocardium infarction, valve thrombosis and peripheral embolic events.
Results: The trial was terminated prematurely because of low enrollment.
There were 27 patients in total: 15 patients placed in the dabigatran
group and 12 in the warfarin group. After 90 days, one patient (8.3 %) in
the warfarin group and none in the dabigatran group had developed a new
intracardiac thrombus. In the dabigatran group, two patients (13.3 %)
developed dense SEC versus one patient (8.3 %) in the warfarin group. In
the warfarin group, one patient (8.3 %) presented ischemic stroke, and
none did in the dabigatran group. We observed no cases of hemorrhagic
stroke, valve thrombosis, embolic events or myocardial infarction in
either group throughout the study. However, one patient (6.7 %) in the
dabigatran group had a fully recovered transient ischemic attack and one
patient in the warfarin group died of heart failure. Conclusions: The use
of dabigatran appears to be similar to warfarin in preventing the
formation of intracardiac thrombus. Trial Registration: Clinicaltrials.gov
NCT01868243.

<30>
[Use Link to view the full text]
Accession Number
20160400813
Author
Bagai A.; Bhatt D.L.; Eikelboom J.W.; Mancini G.B.J.; Cohen E.A.;
Vijayaraghavan R.; Cheema A.N.; Udell J.A.; Niznick J.; Tanguay J.-F.;
Verma S.; Mehta S.R.
Institution
(Bagai, Cheema) Terrence Donnelly Heart Center, St. Michael's Hospital,
University of Toronto, Toronto, ON, Canada
(Bhatt) Brigham and Women's Hospital Heart and Vascular Center, Harvard
Medical School, Boston, MA, United States
(Eikelboom, Mehta) Population Health Research Institute, McMaster
University, Hamilton Health Sciences, ON, Canada
(Mancini) Vancouver Hospital, University of British Columbia, Vancouver,
BC, Canada
(Cohen) Department of Medicine, Sunnybrook Health Sciences Centre,
University of Toronto, Toronto, ON, Canada
(Vijayaraghavan) Division of Cardiology, Rouge Valley Health System,
Scarborough, ON, Canada
(Udell) Peter Munk Cardiac Centre, Toronto General Hospital, University of
Toronto, Toronto, ON, Canada
(Niznick) University of Ottawa, Ottawa, ON, Canada
(Tanguay) Montreal Heart Institute, Universite de Montreal, Montreal, QC,
Canada
(Verma) Division of Cardiac Surgery, Keenen Research Centre for Biomedical
Science, St. Michael's Hospital, 30 Bond St, Toronto, ON M5B 1W8, Canada
(Mehta) Hamilton Health Sciences, General Division, 237 Barton St E,
Hamilton, ON L8L 2X2, Canada
Title
Individualizing duration of dual antiplatelet therapy after acute coronary
syndrome or percutaneous coronary intervention.
Source
Circulation. 133 (21) (pp 2094-2098), 2016. Date of Publication: 24 May
2016.
Publisher
Lippincott Williams and Wilkins

<31>
Accession Number
20160401872
Author
Alabed S.; Sabouni A.; Al Dakhoul S.; Bdaiwi Y.; Frobel-Mercier A.-K.
Institution
(Alabed) The University of Sheffield, Department of Cardiovascular
Science, Sheffield, United Kingdom
(Sabouni) Cairo University, Kasr Al-Ainy School of Medicine, Cairo, Egypt
(Al Dakhoul) The Wirral University Teaching Hospitals, Department of
Medicine, Arrowe Park Road, Upton, Wirral, Merseyside CH49 5PE, United
Kingdom
(Bdaiwi) Damascus University, Faculty of Medicine, Mazzeh, Damascus,
Syrian Arab Republic
(Frobel-Mercier) AstraZeneca, Quantitative Clinical Pharmacology, KC 547,
Pepparedsleden 1, Molndal SE-431 83, Sweden
Title
Beta-blockers for congestive heart failure in children.
Source
Cochrane Database of Systematic Reviews. 2016 (1) (no pagination), 2016.
Article Number: CD007037. Date of Publication: 28 Jan 2016.
Publisher
John Wiley and Sons Ltd (Southern Gate, Chichester, West Sussex PO19 8SQ,
United Kingdom)
Abstract
Background: Beta-blockers are an essential part of standard therapy in
adult congestive heart failure and therefore, are expected to be
beneficial in children. However, congestive heart failure in children
differs from that in adults in terms of characteristics, aetiology, and
drug clearance. Therefore, paediatric needs must be specifically
investigated. This is an update of a Cochrane review previously published
in 2009. Objectives: To assess the effect of beta-adrenoceptor-blockers
(beta-blockers) in children with congestive heart failure. Search methods:
We searched the Cochrane Central Register of Controlled Trials (CENTRAL)
in The Cochrane Library, MEDLINE, EMBASE, and LILACS up to November 2015.
Bibliographies of identified studies were checked. No language
restrictions were applied. Selection criteria: Randomised, controlled,
clinical trials investigating the effect of beta-blocker therapy on
paediatric congestive heart failure. Data collection and analysis: Two
review authors independently extracted and assessed data from the included
trials. Main results: We identified four new studies for the review
update; the review now includes seven studies with 420 participants. Four
small studies with 20 to 30 children each, and two larger studies of 80
children each, showed an improvement of congestive heart failure with
beta-blocker therapy. A larger study with 161 participants showed no
evidence of benefit over placebo in a composite measure of heart failure
outcomes. The included studies showed no significant difference in
mortality or heart transplantation rates between the beta-blocker and
control groups. No significant adverse events were reported with
beta-blockers, apart from one episode of complete heart block. A
meta-analysis of left ventricular ejection fraction (LVEF) and fractional
shortening (LVFS) data showed a very small improvement with beta-blockers.
However, there were vast differences in the age, age range, and health of
the participants (aetiology and severity of heart failure; heterogeneity
of diagnoses and co-morbidities); there was a range of treatments across
studies (choice of beta-blocker, dosing, duration of treatment); and a
lack of standardised methods and outcome measures. Therefore, the primary
outcomes could not be pooled in meta-analyses. Authors' conclusions: There
is not enough evidence to support or discourage the use of beta-blockers
in children with congestive heart failure, or to propose a paediatric
dosing scheme. However, the sparse data available suggested that children
with congestive heart failure might benefit from beta-blocker treatment.
Further investigations in clearly defined populations with standardised
methodology are required to establish guidelines for therapy.
Pharmacokinetic investigations of beta-blockers in children are also
required to provide effective dosing in future trials.

<32>
Accession Number
20160401803
Author
Anderson L.; Thompson D.R.; Oldridge N.; Zwisler A.-D.; Rees K.; Martin
N.; Taylor R.S.
Institution
(Anderson, Taylor) University of Exeter Medical School, Institute of
Health Research, Veysey Building, Salmon Pool Lane, Exeter EX2 4SG, United
Kingdom
(Thompson) Australian Catholic University, Centre for the Heart and Mind,
Mary MacKillop Institute for Health Research, 215 Spring Street,
Melbourne, VIC 3000, Australia
(Oldridge) Aurora Sinai/Aurora St. Luke's Medical Center, University of
Wisconsin School of Medicine and Public Health and Aurora Cardiovascular
Services, Milwaukee, WI, United States
(Zwisler) Rigshospitalet, Copenhagen University Hospital, Department of
Cardiology, The Heart Centre, Blegsdamsvej 9, Copenhagen 2100, Denmark
(Rees) Warwick Medical School, University of Warwick, Division of Health
Sciences, Coventry CV4 7AL, United Kingdom
(Martin) University College London, Farr Institute of Health Informatics
Research, 222 Euston Road, London NW1 2DA, United Kingdom
(Taylor) University of Southern Denmark, National Institute of Public
Health, Copenhagen, Denmark
Title
Exercise-based cardiac rehabilitation for coronary heart disease.
Source
Cochrane Database of Systematic Reviews. 2016 (1) (no pagination), 2016.
Article Number: CD001800. Date of Publication: 05 Jan 2016.
Publisher
John Wiley and Sons Ltd (Southern Gate, Chichester, West Sussex PO19 8SQ,
United Kingdom)
Abstract
Background: Coronary heart disease (CHD) is the single most common cause
of death globally. However, with falling CHD mortality rates, an
increasing number of people live with CHD and may need support to manage
their symptoms and prognosis. Exercise-based cardiac rehabilitation (CR)
aims to improve the health and outcomes of people with CHD. This is an
update of a Cochrane systematic review previously published in 2011.
Objectives: To assess the effectiveness and cost-effectiveness of
exercise-based CR (exercise training alone or in combination with
psychosocial or educational interventions) compared with usual care on
mortality, morbidity and HRQL in patients with CHD. To explore the
potential study level predictors of the effectiveness of exercise-based CR
in patients with CHD. Search methods: We updated searches from the
previous Cochrane review, by searching Cochrane Central Register of
Controlled Trials (CENTRAL) (The Cochrane Library, Issue 6, 2014) from
December 2009 to July 2014. We also searched MEDLINE (Ovid), EMBASE
(Ovid), CINAHL (EBSCO) and Science Citation Index Expanded (December 2009
to July 2014). Selection criteria: We included randomised controlled
trials (RCTs) of exercise-based interventions with at least six months
follow-up, compared with a no exercise control. The study population
comprised men and women of all ages who have had a myocardial infarction
(MI), coronary artery bypass graft (CABG) or percutaneous coronary
intervention (PCI), or who have angina pectoris, or coronary artery
disease. We included RCTs that reported at least one of the following
outcomes: mortality, MI, revascularisations, hospitalisations,
health-related quality of life (HRQL), or costs. Data collection and
analysis: Two review authors independently screened all identified
references for inclusion based on the above inclusion and exclusion
criteria. One author extracted data from the included trials and assessed
their risk of bias; a second review author checked data. We stratified
meta-analysis by the duration of follow up of trials, i.e. short-term: 6
to 12 months, medium-term: 13 to 36 months, and long-term: > 3 years. Main
results: This review included 63 trials which randomised 14,486 people
with CHD. This latest update identified 16 new trials (3872 participants).
The population included predominantly post-MI and post-revascularisation
patients and the mean age of patients within the trials ranged from 47.5
to 71.0 years. Women accounted for fewer than 15% of the patients
recruited. Overall trial reporting was poor, although there was evidence
of an improvement in quality of reporting in more recent trials. As we
found no significant difference in the impact of exercise-based CR on
clinical outcomes across follow-up, we focused on reporting findings
pooled across all trials at their longest follow-up (median 12 months).
Exercise-based CR reduced cardiovascular mortality compared with no
exercise control (27 trials; risk ratio (RR) 0.74, 95% CI 0.64 to 0.86).
There was no reduction in total mortality with CR (47 trials, RR 0.96, 95%
CI 0.88 to 1.04). The overall risk of hospital admissions was reduced with
CR (15 trials; RR 0.82, 95% CI 0.70 to 0.96) but there was no significant
impact on the risk of MI (36 trials; RR 0.90, 95% CI 0.79 to 1.04), CABG
(29 trials; RR 0.96, 95% CI 0.80 to 1.16) or PCI (18 trials; RR 0.85, 95%
CI 0.70 to 1.04). There was little evidence of statistical heterogeneity
across trials for all event outcomes, and there was evidence of small
study bias for MI and hospitalisation, but no other outcome. Predictors of
clinical outcomes were examined across the longest follow-up of studies
using univariate meta-regression. Results show that benefits in outcomes
were independent of participants' CHD case mix (proportion of patients
with MI), type of CR (exercise only vs comprehensive rehabilitation) dose
of exercise, length of follow-up, trial publication date, setting (centre
vs home-based), study location (continent), sample size or risk of bias.
Given the heterogeneity in outcome measures and reporting methods,
meta-analysis was not undertaken for HRQL. In five out of 20 trials
reporting HRQL using validated measures, there was evidence of significant
improvement in most or all of the sub-scales with exercise-based CR
compared to control at follow-up. Four trial-based economic evaluation
studies indicated exercise-based CR to be a potentially cost-effective use
of resources in terms of gain in quality-adjusted life years. The quality
of the evidence for outcomes reported in the review was rated using the
GRADE method. The quality of the evidence varied widely by outcome and
ranged from low to moderate. Authors' conclusions: This updated Cochrane
review supports the conclusions of the previous version of this review
that, compared with no exercise control, exercise-based CR reduces the
risk of cardiovascular mortality but not total mortality. We saw a
significant reduction in the risk of hospitalisation with CR but not in
the risk of MI or revascularisation. We identified further evidence
supporting improved HRQL with exercise-based CR. More recent trials were
more likely to be well reported and include older and female patients.
However, the population studied in this review still consists
predominantly of lower risk individuals following MI or revascularisation.
Further well conducted RCTs are needed to assess the impact of
exercise-based CR in higher risk CHD groups and also those presenting with
stable angina. These trials should include validated HRQL outcome
measures, explicitly report clinical event outcomes including mortality
and hospital admissions, and assess costs and cost-effectiveness.

<33>
Accession Number
72306861
Author
Providencia R.; Rogers D.; Papageorgiou N.; Ioannou A.; Babu G.; Ahsan S.;
Segal O.; Lowe M.; Lambiase P.; Chow A.W.
Institution
(Providencia, Rogers, Papageorgiou, Ioannou, Babu, Ahsan, Segal, Lowe,
Lambiase, Chow) Barts Health NHS Trust, London, United Kingdom
Title
Tri-ventricular pacing improves long-term survival and freedom from
ventricular arrhythmias in advanced heart failure: Results from a
propensity-matched comparison.
Source
European Journal of Heart Failure. Conference: Heart Failure 2016 and the
3rd World Congress on Acute Heart Failure Florence Italy. Conference
Start: 20160521 Conference End: 20160524. Conference Publication:
(var.pagings). 18 (pp 311), 2016. Date of Publication: May 2016.
Publisher
John Wiley and Sons Ltd
Abstract
Background: Bi-Ventricular pacing (Bi-V) is an important adjunctive
treatment in advanced heart failure, but almost one third of patients are
non-responders. Adding a third ventricular lead (Tri-Ventricular pacing
-Tri-V) has shown to be feasible and provide favourable acute results when
assessed by echocardiographic, haemodynamic and clinical endpoints.
However, long-term impact of this approach on survival and hard outcomes
is unknown. Purpose: We aimed to assess the long-term effects of Tri-V
pacing and its impact on long-term survival. Methods: Single-centre
propensity score-matched cohort study comparing 34 advanced heart failure
patients implanted with Tri-V devices with 34 controls treated with Bi-V
comparing clinical outcomes (complications, survival and incidence of
appropriate or inappropriate therapies) over a 10-year time interval.
Results: During amedian of 2,478 days (IQR=1,183-3,214) Tri-V patients
presented with a comparable incidence of complications: lead dislodgement
(Tri-V 0.86 vs. Bi-V 1.10 per 100 patient-years; P=0.742), device-related
infection (Tri-V 1.83 vs. Bi-V 1.76 per 100 patient-years; P=0.996) and
refractory phrenic nerve capture (Tri-V 0.48 vs. Bi-V 1.84 per 100
patient-years; P=0.341). However, Tri-V presented with a trend for shorter
battery longevity (time to Box change: Tri-V 1,758+/-360 vs. Bi-V
1,993+/-408 days; P=0.072). Ventricular arrhythmia episodes requiring
implantable cardioverter-defibrillator intervention occurred more
frequently in the Bi-V group (Tri-V 6.55 vs. Bi-V 16.88 per 100
patient-years; adjusted HR=0.31, 95%CI 0.14-0.66, P=0.002). Lower
all-cause mortality and heart transplant was observed in the Tri-V group
(Tri-V 6.99 vs. Bi-V 11.92 per 100 patient-years; adjusted HR=0.44; 95%CI
0.23-0.85, P=0.015). Conclusion: Tri-V displayed a similar safety profile
when compared with Bi-V and was associated with potential benefits
regarding long-term survival and ventricular arrhythmia burden. Further
randomized controlled studies are required to confirm these promising
results. (Figure presented).

<34>
Accession Number
72306705
Author
Yardley M.; Gullestad L.; Nytroen K.
Institution
(Yardley) Norwegian Health Association, Oslo, Norway
(Gullestad) University of Oslo, Faculty of Medicine, Oslo, Norway
(Nytroen) Oslo University Hospital, Department of Cardiology,
Rikshospitalet, Oslo, Norway
Title
The long term effects of high intensity exercise; a 5 years follow-up of a
randomized controlled trial in heart transplant recipients.
Source
European Journal of Heart Failure. Conference: Heart Failure 2016 and the
3rd World Congress on Acute Heart Failure Florence Italy. Conference
Start: 20160521 Conference End: 20160524. Conference Publication:
(var.pagings). 18 (pp 260), 2016. Date of Publication: May 2016.
Publisher
John Wiley and Sons Ltd
Abstract
Background: High-intensity interval training (HIT) has repeatedly proven
to be superior to moderate continuous exercise regarding improvement of
aerobic capacity in normal subjects and patients with established heart
disease. Heart transplanted (HTx) patients has traditionally not been
exposed to HIT because of chronotropic incompetence, but we have recently
shown that HIT is safe and efficient also in this group. We now report 5
yr long-term effects of this intervention. Purpose: To evaluate the long-
term effects of HIT. Method: 48 HTx patients completed a randomized
control trial at our hospital in 2009-2011, comparing a 12-month HIT
intervention with usual care. Four years after completed intervention, 41
patients were eligible for follow-up testing, to evaluate long-term
effects of HIT. The patients underwent cardiopulmonary exercise testing,
blood sampling, echocardiography, intravascular ultrasound (IVUS) in
coronary arteries, health-related quality of life questionnaires (QoL),
measurement of body composition and isokinetic testing of muscle strength.
Results: Mean age (SD) of the patients at baseline was 49 (16) yr, 68 %
men and mean years after HTx was 4 (2) yr. During 12 months of HIT,
VO2peak increased significantly from 27.7 (5.7) to 31.2 (5.3) and
thereafter decreased to 26.0 (6.2) ml/kg/min at 5 yr follow-up, while it
remained slightly decreased during the whole period in the control group:
28.9(6.7), 28.7 (6.3) and 26.1 (7.1) mL/kg/min at baseline, 12 mo and 5 yr
respectively. The HIT-group also had significantly higher muscular
capacity and less coronary artery vasculopathy (CAV) at 12 mo. Analysis of
variance (baseline, 12 mo, 5 yr) showed no changes between groups in
VO2peak, muscular capacity, body composition, weight, chronotropic
responses during exercise, glucose tolerance or lipid profile. The
indifferences in aerobic performance between groups, was in line with the
similar everyday activity frequency and intensity measured by senseWear
armband at 5 yr follow-up. Conclusion: Patients who had completed a 12
month HIT-intervention were not able to maintain their high post-exercise
VO2peak levels and muscle capacity during long-term follow up. There were
no significant differences in VO2peak levels between the two groups at 5
yr follow-up and they reported similar activity frequency and intensity.
Despite the reduced VO2peak other positive effects may have sustained: for
example the reduced CAV progression, which currently is being analyzed.
However, our findings so far suggest that moderate levels of exercise and
intensity are insufficient in order to maintain the achieved VO2peak
levels. Intermittent periods of HIT are probably necessary to maintain
high VO2peak levels. (Figure Presented).

<35>
Accession Number
72306123
Author
Ak A.; Porokhovnikov I.; Kuethe F.; Noutsias M.; Schlattmann P.
Institution
(Ak, Porokhovnikov, Schlattmann) Institute of Medical Statistics,
Friedrich-Schiller University Jena, Jena, Germany
(Kuethe) HELIOS Klinik Herzberg/Osterode, Department of Cardiology,
Herzberg am Harz, Germany
(Noutsias) University Hospital Jena, Department of Cardiology, KIM I,
Jena, Germany
Title
Comparison of transcatheter aortic valve implantation versus surgical
aortic valve replacement and medical treatment: A systematic review and
meta-analysis.
Source
European Journal of Heart Failure. Conference: Heart Failure 2016 and the
3rd World Congress on Acute Heart Failure Florence Italy. Conference
Start: 20160521 Conference End: 20160524. Conference Publication:
(var.pagings). 18 (pp 82), 2016. Date of Publication: May 2016.
Publisher
John Wiley and Sons Ltd
Abstract
Introduction: Transcatheter aortic valve replacement (TAVI) is a promising
therapy option for patients with severe aortic stenosis, multiple
comorbidities and high risk for surgical aortic valve replacement (SAVR).
Purpose: To compare TAVI with SAVR and with medical therapy (MT) by
meta-analysis. Methods: A systematic review was conducted by two
independent investigators. We carried out literature search using Medline
(via PubMed), the Cochrane Library and Embase, and reference lists of
identified primary studies. We included articles written in English,
German, or Turkish that compared TAVI with other treatment options based
on all cause-mortality, and which contained baseline characteristics of
Gender, Age and EuroSCORE. Patients without aortic stenosis, healthy
subjects and data with less than 30-days follow-up time were excluded.
Relative Risk (RR) was calculated and graphically displayed in forest
plots. We used I2 for heterogeneity and determined the source of it by
metaregression. Funnel plots were investigated by Egger's regression test
of asymmetry. Results: 22 studies, existing of 19 observational studies
and three randomized controlled trials, with a total of 6.539 patients
were included. Compared with MT, TAVI showed a statistically significant
benefit for all-cause mortality at 12 months (RR=0.68, 95% CI 0.49-0.95)
and at 24 months (RR=0.75, 95% CI 0.44-1.27). TAVI versus SAVR, overall
result on 12 months showed significant advantage for SAVR (RR=1.23, 95% CI
0.95-1.60). To be in contrast with that our subgroup analysis with two
randomized controlled trials militated here a minimal better result for
TAVI (RR=0.91, 95% CI 0.91-1.14). Long-term outcome between SAVR and TAVI
at 2 years presented no significant difference (RR=1.09, 95% CI
1.01-1.17). Mean age showed a substantial influence on long-term survival
(OR=7.375, 95%CI 0.78-69.43).