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<1>
Accession Number
2010558160
Authors
Basalus M.W.Z. Tandjung K. van Houwelingen K.G. Stoel M.G. de Man F.H.A.F.
Louwerenburg J.W. Said S.A.M. Linssen G.C.M. Kleijne M.A.W.J. Van der
Palen J. Huisman J. Verhorst P.M.J. von Birgelen C.
Institution
(Basalus, Tandjung, van Houwelingen, Stoel, de Man, Louwerenburg, Huisman,
Verhorst) Department of Cardiology, Thoraxcentrum Twente, Medisch Spectrum
Twente, Enschede, Netherlands
(Said) Department of Cardiology, Hospital Group Twente, Hengelo,
Netherlands
(Linssen) Department of Cardiology, Hospital Group Twente, Almelo,
Netherlands
(Kleijne) Department of Cardiology, Streekziekenhuis Koningin Beatrix,
Winterswijk, Netherlands
(Van der Palen) Department of Epidemiology, Medisch Spectrum Twente,
Enschede and Department of Research Methodology, Measurement and Data
Analysis, University of Twente, Enschede, Netherlands
(von Birgelen) Department of Cardiology, Thoraxcentrum Twente, Medisch
Spectrum Twente, Enschede, and MIRA, Institute for Biomedical Technology
and Technical Medicine, University of Twente, Enschede, Netherlands
Title
Twente study: The real-world endeavor resolute versus xience V
drug-eluting stent study in twente: Study design, rationale and
objectives.
Source
Netherlands Heart Journal. 18 (7-8) (pp 360-364), 2010. Date of
Publication: August 2010.
Publisher
Bohn Stafleu van Loghum (P.O. Box 246, Houten 3990 GA, Netherlands)
Abstract
Background. New-generation drug-elutingstents (DES) may solve several
problems encountered with first-generation DES, but there is a lack of
prospective head-to-head comparisons between new-generation DES. In
addition, the outcome of regulatory trials may not perfectly reflect the
outcome in 'real world' patients. Objectives. To compare the efficacy and
safety of two new-generation DES in a 'real world' patient population.
Methods. A prospective, randomised, singleblinded clinical trial to
evaluate clinical outcome after Endeavor Resolute vs. Xience V stent
implantation. The primary endpoint is target vessel failure at one-year
follow-up. In addition, the study comprises a two-year and an open-label
five-year follow-up.

<2>
Accession Number
2010547947
Authors
Pires L.M. Leiria T.L.L. De Lima G.G. Kruse M.L. Nesralla I.A. Kalil
R.A.K.
Institution
(Pires, Leiria, De Lima, Kruse) Department of Electrophysiology, IC/FUC,
Porto Alegre, Brazil
(Nesralla, Kalil) Department of Cardiovascular Surgery, IC/FUC, Porto
Alegre, Brazil
(De Lima, Kalil) Department of Cardiology, Universidade Federal de
Ciencias da Saude de Porto Alegre (UFSCPA), Porto Alegre, Brazil
Title
Comparison of surgical cut and sew versus radiofrequency pulmonary veins
isolation for chronic permanent atrial fibrillation: A randomized study.
Source
PACE - Pacing and Clinical Electrophysiology. 33 (10) (pp 1249-1257),
2010. Date of Publication: October 2010.
Publisher
Blackwell Publishing Inc. (350 Main Street, Malden MA 02148, United
States)
Abstract
Background: Surgical pulmonary veins isolation (PVI) is done to restore
sinus rhythm (SR) in patients with chronic permanent atrial fibrillation
(CPAF) and mitral valve disease. Here we compare the efficacy of
electrical block lines performed with radiofrequency (RF) compared with
conventional surgery. Methods: Randomized trial of 22 patients with CPAF
and indication for mitral valve surgery. Ten patients underwent
conventional surgery (SURG) and 12 RF. To prove the efficacy of the
blockage lines, epicardial pacemaker wires were placed in the isolated
pulmonary veins region (IPVR) and right atria (RA). Results: There were no
differences in the baseline data among the groups. All patients remained
in SR during the immediate postoperative period. Block lines were tested
in patients who remained in SR during the following days (eight in SURG
and nine in RF). The median value of thresholds to conduct the stimulus of
IPVR for the RA was 18 mA in SURG and 3 mA in RF (P < 0.022). Eight SURG
patients and seven RF patients (P < 0.38) remained in SR at hospital
discharge. Eleven RF patients and one SURG required amiodarone to maintain
SR (P < 0.001). The incidence of recurrent atrial fibrillation (AF) in the
follow-up was 10.7/100 patients/year in the SURG group versus 73.1/100
patients/year in the RF group (P = 0.009). Conclusions: PVI by SURG formed
more effective block lines than RF. SR at hospital discharge was similar
among the groups, but more amiodarone was used in RF. During follow-up,
incidence of recurrent AF was higher in the RF group. 2010 Wiley
Periodicals, Inc.

<3>
Accession Number
2010553298
Authors
Park D.-W. Kim Y.-H. Yun S.-C. Kang S.-J. Lee S.-W. Lee C.-W. Park S.-W.
Seong I.-W. Lee J.-H. Tahk S.-J. Jeong M.-H. Jang Y. Cheong S.-S. Yang
J.-Y. Lim D.-S. Seung K.-B. Chae J.-K. Hur S.-H. Lee S.-G. Yoon J. Lee
N.-H. Choi Y.-J. Kim K.-S. Kim H.-S. Hong T.-J. Park H.-S. Park S.-J.
Institution
(Park, Kim, Yun, Kang, Lee, Lee, Park, Park) Department of Cardiology,
Center for Medical Research and Information, University of Ulsan College
of Medicine, Seoul, South Korea
(Yun) Division of Biostatistics, Center for Medical Research and
Information, University of Ulsan College of Medicine, Seoul, South Korea
(Seong, Lee) Chungnam National University Hospital, Daejeon, South Korea
(Tahk) Ajou University Medical Center, Suwon, South Korea
(Jeong) Chonnam National University Hospital, Gwangju, South Korea
(Jang) Yonsei University Severance Hospital, Seoul, South Korea
(Cheong) GangNeung Asan Medical Center, GangNeung, South Korea
(Yang) NHIC Ilsan Hospital, Ilsan, South Korea
(Lim) Korea University Medical College, Seoul, South Korea
(Seung) Catholic University of Korea, St. Mary's Hospital, Seoul, South
Korea
(Chae) Chonbuk National University Hospital, Jeonju, South Korea
(Hur) Keimyung University Dongsan Medical Center, Daegu, South Korea
(Lee) Ulsan University Hospital, Ulsan, South Korea
(Yoon) Yonsei University, Wonju Christian Hospital, Wonju, South Korea
(Lee) Soonchunhyang University, Bucheon Hospital, Bucheon, South Korea
(Choi, Kim) Hallym University, Sacred Heart Hospital, Anyang, South Korea
(Kim) Daegu Catholic University Medical Center, Daegu, South Korea
(Kim) Seoul National University Hospital, Seoul, South Korea
(Hong) Pusan National University Hospital, Pusan, South Korea
(Park) Kyung Pook National University Hospital, Daegu, South Korea
Title
Comparison of zotarolimus-eluting stents with sirolimus- and
paclitaxel-eluting stents for coronary revascularization: The ZEST
(Comparison of the Efficacy and Safety of Zotarolimus-Eluting Stent with
Sirolimus-Eluting and PacliTaxel-Eluting Stent for Coronary Lesions)
randomized trial.
Source
Journal of the American College of Cardiology. 56 (15) (pp 1187-1195),
2010. Date of Publication: 05 Oct 2010.
Publisher
Elsevier USA (6277 Sea Harbor Drive, Orlando FL 32862 8239, United States)
Abstract
Objectives The aim of this study was to evaluate the relative efficacy and
safety of zotarolimus-eluting stents (ZES) in comparison with the
established and widely used sirolimus- (SES) and paclitaxel-eluting stents
(PES) in routine clinical practice. Background Whether ZES might provide
similar clinical and angiographic outcomes in a broad spectrum of patients
compared with SES or PES is undetermined. Methods We performed a
single-blind, multicenter, prospectively randomized trial to compare ZES
with SES and PES in 2,645 patients undergoing percutaneous coronary
intervention. The primary end point was a composite of major adverse
cardiac events (MACE) (death, myocardial infarction, and ischemia-driven
target vessel revascularization) at 12 months. A noninferiority comparison
(ZES vs. SES) and a superiority comparison (ZES vs. PES) were performed
for the primary end point. Results Baseline clinical and angiographic
characteristics were similar in the 3 groups. At 12 months, the ZES group
showed noninferior rates of MACE compared with the SES group (10.2% vs.
8.3%, p for noninferiority = 0.01, p for superiority = 0.17) and
significantly fewer MACE than the PES group (10.2% vs. 14.1%, p for
superiority = 0.01). The incidence of death or myocardial infarction was
similar among the groups (ZES vs. SES vs. PES, 5.8% vs. 6.9% vs. 7.6%,
respectively, p = 0.31). The incidence of stent thrombosis was
significantly lower in the SES group (ZES vs. SES vs. PES, 0.7% vs. 0% vs.
0.8%, respectively, p = 0.02). Conclusions In this large-scale, practical
randomized trial, the use of ZES resulted in similar rates of MACE
compared with SES and in fewer MACE compared with PES at 12 months.
(Comparison of the Efficacy and the Safety of Zotarolimus-Eluting Stent
Versus Sirolimus-Eluting Stent and PacliTaxel-Eluting Stent for Coronary
Lesions; NCT00418067) 2010 American College of Cardiology Foundation.

<4>
Accession Number
2010556059
Authors
Glasziou P.P. Clarke P. Alexander J. Rajmokan M. Beller E. Woodward M.
Chalmers J. Poulter N. Patel A.
Institution
(Glasziou) Clinical Epidemiology and Biostatistics, Bond University, Gold
Coast, QLD, Australia
(Clarke) Department of Public Health, University of Sydney, Sydney, NSW,
Australia
(Alexander, Beller) Queensland Clinical Trials Centre, University of
Queensland, Brisbane, QLD, Australia
(Rajmokan) Centre for Healthcare Related Infection Surveillance and
Prevention, Queensland Health, Brisbane, QLD, Australia
(Woodward, Patel) Cardiovascular Division, George Institute for
International Health, Sydney, NSW, Australia
(Poulter) Department of Preventive Cardiovascular Medicine, Imperial
College London, London, United Kingdom
(Woodward) Department of Biostatistics, University of Sydney, Sydney, NSW,
Australia
(Chalmers) Department of Medicine, University of Sydney, Sydney, NSW,
Australia
(Chalmers) George Institute for International Health, Sydney, NSW,
Australia
Title
Cost-effectiveness of lowering blood pressure with a fixed combination of
perindopril and indapamide in type 2 diabetes mellitus: An ADVANCE
trial-based analysis.
Source
Medical Journal of Australia. 193 (6) (pp 320-324), 2010. Date of
Publication: 20 Sep 2010.
Publisher
Australasian Medical Publishing Co. Ltd (Level 2, 26-32 Pyrmont Bridge
Road, Pyrmont NSW 2009, Australia)
Abstract
Objective: To determine the cost-effectiveness of routine administration,
irrespective of blood pressure (BP), of a fixed-dose combination of
perindopril and indapamide to patients with type 2 diabetes mellitus.
Design, setting and participants: Prospective cost-effectiveness analysis
within the Action in Diabetes and Vascular Disease: Preterax and
Diamicron-MR Controlled Evaluation (ADVANCE) trial, an international,
multicentre, randomised controlled trial of 11 140 participants with type
2 diabetes randomly allocated to receive perindopril plus indapamide
(4mg-1.25mg/day) or placebo. Main outcome measures: Health-related
quality-of-life measured by the EuroQol-5D, resource utilisation, and
cost-effectiveness (cost per death averted at 4.3 years' average
follow-up, and estimated cost per life-year gained, by extrapolation).
Results: The mean health-related quality-of-life score of survivors was
0.80 (on a 0-1 scale [death to full health]), with no difference between
treatment groups. Active treatment reduced hospital admissions for
coronary heart disease and coronary revascularisation by 5%. For the
Australian participants, perindopril-indapamide cost A$1368 per patient
during the trial period, but reduced total hospitalisation costs by A$410
and other medication costs (mainly other BP-lowering drugs) by A$332. The
absolute reduction in all-cause mortality for the active treatment group
was 1.1%, giving a cost per life saved of A$49 200. Lifetime extrapolation
gave an estimated cost per life-year saved of A$10 040 (discounted at 5%
per year). Conclusion: The combination of perindopril and indapamide in
patients with type 2 diabetes appears to be cost-effective. Trial
registration: United States National Library of Medicine NCT00145925.

<5>
Accession Number
2010538161
Authors
Winchester D.E. Wen X. Xie L. Bavry A.A.
Institution
(Winchester, Bavry) Division of Cardiovascular Medicine, University of
Florida, Gainesville, FL, United States
(Wen) Department of Epidemiology and Health Policy Research, University of
Florida, Gainesville, FL, United States
(Xie) College of Medicine, University of Florida, Gainesville, FL, United
States
Title
Evidence of pre-procedural statin therapy: A meta-analysis of randomized
trials.
Source
Journal of the American College of Cardiology. 56 (14) (pp 1099-1109),
2010. Date of Publication: 28 Sep 2010.
Publisher
Elsevier USA (6277 Sea Harbor Drive, Orlando FL 32862 8239, United States)
Abstract
Objectives: The purpose of this study was to summarize the evidence of
pre-procedural statin therapy to reduce periprocedure cardiovascular
events. Background: Invasive procedures can result in adverse
cardiovascular events, such as myocardial infarction (MI) and death. We
hypothesized that statins might improve clinical outcomes when used before
invasive procedures. Methods: We searched the MEDLINE, Cochrane, and
clinicaltrials.gov databases from inception to February 2010 for
randomized, controlled trials that examined statin therapy before invasive
procedures. Invasive procedures were defined as percutaneous coronary
intervention, coronary artery bypass grafting (CABG), and noncardiac
surgery. We required that studies initiated statins before the procedure
and reported clinical outcomes. A DerSimonian-Laird model was used to
construct random-effects summary risk ratios. Results: Eight percent of
the screened trials (21 of 270) met our selection criteria, which included
4,805 patients. The use of pre-procedural statins significantly reduced
post-procedural MI (risk ratio [RR]: 0.57, 95% confidence interval [CI]:
0.46 to 0.70, p < 0.0001). This benefit was seen after both percutaneous
coronary intervention (p < 0.0001) and noncardiac surgical procedures (p =
0.004), but not CABG (p = 0.40). All-cause mortality was nonsignificantly
reduced by statin therapy (RR: 0.66, 95% CI: 0.37 to 1.17, p = 0.15).
Pre-procedural statins also reduced post-CABG atrial fibrillation (RR:
0.54, 95% CI: 0.43 to 0.68, p < 0.0001). Conclusions: Statins administered
before invasive procedures significantly reduce the hazard of
post-procedural MI. Additionally, statins reduce the risk of atrial
fibrillation after CABG. The routine use of statins before invasive
procedures should be considered. 2010 American College of Cardiology
Foundation.

<6>
Accession Number
2010538166
Authors
Rosenson R.S. Hislop C. Elliott M. Stasiv Y. Goulder M. Waters D.
Institution
(Rosenson) Mount Sinai Heart, Mount Sinai School of Medicine, One Gustave
Levy Place, New York, NY 10029, United States
(Hislop, Elliott, Stasiv) Anthera Pharmaceuticals, Hayward, CA, United
States
(Goulder) Worldwide Clinical Trials, Nottingham, United Kingdom
(Waters) University of California San Francisco, San Francisco, CA, United
States
Title
Effects of varespladib methyl on biomarkers and major cardiovascular
events in acute coronary syndrome patients.
Source
Journal of the American College of Cardiology. 56 (14) (pp 1079-1088),
2010. Date of Publication: 28 Sep 2010.
Publisher
Elsevier USA (6277 Sea Harbor Drive, Orlando FL 32862 8239, United States)
Abstract
Objectives The purpose of this study was to investigate the effects of
varespladib on cardiovascular biomarkers in acute coronary syndrome
patients. Background Secretory phospholipase A₂
(sPLA₂) represents a family of proatherogenic enzymes that
hydrolyze lipoprotein phospholipids, increasing their affinity for intimal
proteoglycans; contribute to cholesterol loading of macrophages by
nonscavenger receptor mediated pathways; and activate inflammatory
pathways. In prospective studies, high sPLA₂-IIA levels
predicted major adverse cardiovascular events in acute coronary syndrome
(ACS) and stable coronary heart disease patients. Methods This randomized,
double-blind, prospective controlled clinical trial (phase 2B) was
designed to investigate the effects of sPLA₂ inhibition with
varespladib 500 mg daily versus placebo as adjunctive therapy to
atorvastatin 80 mg daily on biomarkers (low-density lipoprotein
cholesterol [LDL-C], high-sensitivity C-reactive protein [hsCRP], and
sPLA₂-IIA levels), major adverse cardiovascular events
(unstable angina, myocardial infarction, death), and safety. In all, 625
ACS subjects were randomized within 96 h of the index event and treated
for a minimum of 6 months. Results After 8 weeks (primary efficacy end
point), varespladib/atorvastatin reduced mean LDL-C levels from baseline
by 49.6% compared with 43.4% with placebo/atorvastatin (p = 0.002).
Respective 8-week median reductions in sPLA₂-IIA levels were
82.4% and 15.6% (p < 0.0001), and hsCRP levels were lowered by 75.0% and
71.0% (p = 0.097). At 24 weeks, respective reductions with varespladib and
placebo were as follows: LDL-C 43.5% versus 37.6% (p < 0.05), hsCRP 79.8%
versus 77.0% (p = 0.02), and sPLA₂-IIA 78.5% versus 6.4% (p <
0.0001). Major adverse cardiovascular events were not different from
placebo 6 months post-randomization (7.3% varespladib vs. 7.7% placebo).
No treatment differences in elevated liver function studies on >1 occasion
were observed. Conclusions Varespladib therapy effectively reduced LDL-C
and inflammatory biomarkers in ACS patients treated with conventional
therapy including atorvastatin 80 mg daily. There were no treatment
differences in clinical cardiovascular events. (FRANCIS [Fewer Recurrent
Acute Coronary Events With Near-Term Cardiovascular Inflammation
Suppression]-ACS Trial: A Study of the Safety and Efficacy of A 002 in
Subjects With Acute Coronary Syndromes; NCT00743925). 2010 American
College of Cardiology Foundation.

<7>
Accession Number
2010550349
Authors
Davoudi M. Farhanchi A. Moradi A. Bakhshaei M.H. Safarpour G.
Institution
(Davoudi, Farhanchi, Moradi, Bakhshaei, Safarpour) Ekbatant Hospital,
Hamadan University of Medical Sciences, Hamadan, Iran, Islamic Republic of
Title
The effect of low tidal volume ventilation during cardio-pulmonary bypass
on postoperative pulmonary function.
Source
Journal of Tehran University Heart Center. 5 (3) (pp 128-131), 2010.
Date of Publication: 2010.
Publisher
Tehran University of Medical Sciences (North Kargar Street, Tehran
1411713138, Iran, Islamic Republic of)
Abstract
Background: Postoperative pulmonary dysfunction is one of the most
frequent complications after cardiac surgery and it is believed to result
from the use of cardiopulmonary bypass (CPB). In this study, we
investigated the effect of low tidal volume ventilation during CPB on
postoperative gas exchange and lung mechanics. Methods: This prospective
randomized study included 100 patients undergoing elective coronary artery
bypass grafting. In 50 patients, low tidal volume ventilation [tidal
volume (TV) = 3 ml/kg, respiratory rate (RR) = 12/min, fraction of
inspiratory oxygen (FIO2)= 1.0, positive end expiratory pressure (PEEP) =
5 cmH₂O] was applied during CPB (group I); and in the other 50
patients (group II), the lungs were open to the atmosphere without
ventilation. Measurements were taken preoperatively, after CPB, and before
discharge. Results: Post-bypass PaO2 (just after CPB 85 versus75) was
higher significantly in group I (P value < 0.05). Decrease in
postoperative forced expiratory volume in 1 second (25% versus 30%) and
forced vital capacity (32% versus 35%) was less significant in group I.
Also, time to extubation (5 hrs versus 5.5 hrs) was shorter in group I.
Conclusion: Continued low tidal volume ventilation during CPB improved
post-bypass oxygenation and lung mechanics.

<8>
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Accession Number
2010552555
Authors
Bekker A. Didehvar S. Kim S. Golfinos J.G. Parker E. Sapson A. Haile M.
Kline R. Lee M.
Institution
(Bekker, Didehvar, Kim, Sapson, Haile, Kline, Lee) Department of
Anesthesiology, New York University Medical Center, New York, NY, United
States
(Golfinos, Parker) Department of Neurosurgery, New York University Medical
Center, New York, NY, United States
Title
Efficacy of clevidipine in controlling perioperative hypertension in
neurosurgical patients: Initial single-center experience.
Source
Journal of Neurosurgical Anesthesiology. 22 (4) (pp 330-335), 2010. Date
of Publication: October 2010.
Publisher
Lippincott Williams and Wilkins (530 Walnut Street, Philadelphia PA
19106-3621, United States)
Abstract
Background: Acute blood pressure (BP) elevations in neurosurgical patients
are associated with serious neurologic, cardiovascular, or surgical site
complications. Clevidipine, an ultra-short-acting dihydropyridine calcium
antagonist, has been shown to be efficacious and safe for acute
hypertension in cardiac surgery. This study assessed the efficacy and
safety of clevidipine in controlling perioperative hypertension in the
neurosurgical setting. Methods: Patients scheduled for intracranial
surgery were prospectively enrolled after giving consent. Clevidipine
(0.5mg/mL in 20% lipid solution, which was to be initiated at 10mg/h and
titrated to effect) was administered as the primary antihypertensive agent
for perioperative hypertension, with target BPs of less than 130mm Hg.
Other vasoactive drugs were administered as needed for treating systolic
BP (SBP) less than 90mm Hg or greater than 130mm Hg. The primary study
endpoint was the proportion of patients not requiring rescue
antihypertensives to maintain target SBP (<130mm Hg). Results: Twenty-two
patients were enrolled. One patient did not require antihypertensive
therapy. Seventeen patients (17 of 21, 81%) were treated with clevidipine
alone; one received clevidipine in the postanesthesia care unit only.
Twenty-eight hypertensive episodes (defined as any new acute BP elevation
requiring clevidipine initiation) were documented. SBP was reduced to
target level within 15 minutes in 22 of 28 episodes (78.6%). Two mild
hypotensive episodes occurred after the initiation of clevidipine
infusion; these transient decreases in BP were treated with vasoactive
drugs and resolved within 5 minutes. Conclusions: Clevidipine is effective
and safe for perioperative hypertension in patients undergoing
intracranial procedures. Rapid control of BP is possible with higher
starting doses. Drug effects resolved rapidly after drug discontinuation.
2010 by Lippincott Williams & Wilkins.

<9>
Accession Number
70275343
Authors
Altrichter J. Scholz M.
Source
Inflammation Research. Conference: 8th World Congress on Trauma, Shock,
Inflammation and Sepsis in Conjunction with 23rd SIS-Europe Congress on
Surgical Infections and the 2nd Interdisciplinary Summit on Inflammation,
TSIS 2010 Munich Germany. Conference Start: 20100309 Conference End:
20100313. Conference Publication: (var.pagings). 59 (pp s62), 2010.
Date of Publication: March 2010.
Publisher
Birkhauser Verlag Basel
Abstract
Drug eluting stents have shown the enormous economic and medical potential
of combination products by creating a five billion dollar market within 5
years. Even broader indications are anticipated from combination products
consisting of a device and a biopharmaceutical protein like antibodies or
growth factors. One major drawback for the production of these
biologic-device combinations products is the lack of safe terminal
sterilization tech-nologies, because proteins denature during irradiation
or gas sterilization with ethylene oxide. Therefore, these products have
to be produced under aseptic conditions, resulting in a sterility
assurance level (SAL) of only 10E-3. In order to overcome this obstacle,
we developed a Stabilizing Postcoating Technology for the
three-dimensional stabilization of proteins. This protective coating
preserves the biological function of biologic-device combination products
during sterilization and sub-sequent storage, resulting in reduced
production costs and higher product safety (SAL 10E-6). The Stabilizing
Postcoating has been shown to protect even very large proteins of up to
one million Dalton during beta or gamma irradiation with >25 kGy and even
ethylene oxide. One example that recently was evaluated in a prospective
randomized controlled clinical trial is the Leukocyte Inhibition Module
(LIM). Here, a highly fragile agonistic anti-Fas IgM antibody is
immobilized on polyurethane foam and inserted into the cardiopulmonary
bypass of patients with generalized inflammation during heart surgery. The
interaction of the antibody rapidly induces the inactivation and
sub-sequent apoptosis of the activated leukocytes. This stabilizing
nanocoating technology is expected to boost the evolving market of
biologic-device combination products by enabling the manufacturers to use
standard production technologies instead of costly aseptic production
environments resulting in lower validation and regulatory burden while at
the same time increasing product safety.