The Experts below are selected from a list of 30891 Experts worldwide ranked by ideXlab platform
David L. Hayes - One of the best experts on this subject based on the ideXlab platform.
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early detection of an underperforming implantable cardiovascular Device using an automated safety surveillance tool
Circulation-cardiovascular Quality and Outcomes, 2012Co-Authors: Robert G. Hauser, Andrew S. Mugglin, Paul A. Friedman, Daniel B. Kramer, Linda M. Kallinen, Deepa Mcgriff, David L. HayesAbstract:Background—Postmarket medical Device surveillance in the United States depends largely on voluntary reporting of adverse events. Consequently, early safety signals may be missed, exposing patients to potentially hazardous products. The aim of this study was to assess the feasibility of using an automated safety surveillance tool to detect early signals that a marketed implantable Cardiac Device was underperforming. Methods and Results—For this purpose, we performed simulated prospective monthly full-cohort and propensity-matched comparative survival analyses on our 3-center database of Sprint Fidelis and Quattro Secure implantable cardioverter-defibrillator leads, using a commercially available automated surveillance tool that was preset to trigger an alert if the log rank probability value was <0.05. During the study, 84 of 1035 Fidelis (8.1%) and 23 of 1675 Quattro (1.4%) leads failed. The simulated full-cohort analysis triggered a sustained alert for Fidelis leads beginning 13 months after the first im...
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Early Detection of an Underperforming Implantable Cardiovascular Device Using an Automated Safety Surveillance Tool
Circulation: Cardiovascular Quality and Outcomes, 2012Co-Authors: Robert G. Hauser, Andrew S. Mugglin, Paul A. Friedman, Daniel B. Kramer, Linda M. Kallinen, Deepa Mcgriff, David L. HayesAbstract:Background—Postmarket medical Device surveillance in the United States depends largely on voluntary reporting of adverse events. Consequently, early safety signals may be missed, exposing patients to potentially hazardous products. The aim of this study was to assess the feasibility of using an automated safety surveillance tool to detect early signals that a marketed implantable Cardiac Device was underperforming. Methods and Results—For this purpose, we performed simulated prospective monthly full-cohort and propensity-matched comparative survival analyses on our 3-center database of Sprint Fidelis and Quattro Secure implantable cardioverter-defibrillator leads, using a commercially available automated surveillance tool that was preset to trigger an alert if the log rank probability value was
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Definition of performance metrics and methods for screening for sudden Cardiac arrest risk at a tertiary care medical center
Journal of Interventional Cardiac Electrophysiology, 2011Co-Authors: Robert F. Rea, David L. Hayes, Douglas Beinborn, Tracy Webster, Nancy Acker, Tammy Kester, Mark McconnellAbstract:Purpose The purpose of this study is to describe the results of manual and automatic electronic medical record-based screening of patients at risk of sudden Cardiac arrest (SCA) based on measurements of left ventricular ejection fraction (LVEF). Methods Counseling regarding SCA risk and implantable cardioverter defibrillator (ICD) therapy is underutilized in patients with reduced LVEF. We developed and implemented an electronic medical record (EMR)-based system for screening of such patients to improve care. In phase one, manual screening of electronic records and LVEF databases was initially performed by trained Cardiac Device nurses. In phase two, records were screened automatically by a customized program, and candidate patient records were sent to Cardiac Device nurses for final review and disposition. Results In phase one, 2,531 patients with LVEF ≤35% were identified over 398 days. Manual EMR review showed that 1,918 patients (76%) received appropriate counseling regarding SCA risk, received ICDs, or had disqualifying comorbidities. In phase two, 1,081 patients with LVEF ≤35% were identified after automatic screening of 44,672 echocardiograms and EMR over 251 days. Of these, 513 patients (58%) received appropriate counseling regarding SCA risk, received ICDs, or had disqualifying comorbidities. Conclusions These data detail the utilization of consultation regarding SCA risk and ICDs in patients with reduced LVEF at a tertiary care center with ready access to arrhythmia specialists. Notification of primary providers of reduced LVEF with recommendation for consultation was not effective in improving patient care.
Muthu Jayabalan - One of the best experts on this subject based on the ideXlab platform.
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a new generation of high flex life polyurethane urea for polymer heart valve studies on in vivo biocompatibility and biodurability
Journal of Biomedical Materials Research Part A, 2008Co-Authors: Vinoy Thomas, Muthu JayabalanAbstract:Development of new generation high flex life polyurethane urea (HFL18-PU) with appropriate elastic modulus, biocompatibility, blood compatibility, resistant to calcification, and biodurability for the long-term use as Cardiac Device is still a challenge. This study reports the development of a fully aliphatic, ether-free physically cross-linked and low elastic modulus (6.841 ± 0.27 MPa) polyurethane urea having in vivo biostability, in vivo biocompatibility and high flex-life (721 ± 30 million cycles) that can satisfy the requirements for the fabrication of tri-leaflet heart valve. © 2008 Wiley Periodicals, Inc. J Biomed Mater Res, 2009
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A new generation of high flex life polyurethane urea for polymer heart valve—Studies on in vivo biocompatibility and biodurability
Journal of Biomedical Materials Research Part A, 2008Co-Authors: Vinoy Thomas, Muthu JayabalanAbstract:Development of new generation high flex life polyurethane urea (HFL18-PU) with appropriate elastic modulus, biocompatibility, blood compatibility, resistant to calcification, and biodurability for the long-term use as Cardiac Device is still a challenge. This study reports the development of a fully aliphatic, ether-free physically cross-linked and low elastic modulus (6.841 ± 0.27 MPa) polyurethane urea having in vivo biostability, in vivo biocompatibility and high flex-life (721 ± 30 million cycles) that can satisfy the requirements for the fabrication of tri-leaflet heart valve. © 2008 Wiley Periodicals, Inc. J Biomed Mater Res, 2009
Robert G. Hauser - One of the best experts on this subject based on the ideXlab platform.
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early detection of an underperforming implantable cardiovascular Device using an automated safety surveillance tool
Circulation-cardiovascular Quality and Outcomes, 2012Co-Authors: Robert G. Hauser, Andrew S. Mugglin, Paul A. Friedman, Daniel B. Kramer, Linda M. Kallinen, Deepa Mcgriff, David L. HayesAbstract:Background—Postmarket medical Device surveillance in the United States depends largely on voluntary reporting of adverse events. Consequently, early safety signals may be missed, exposing patients to potentially hazardous products. The aim of this study was to assess the feasibility of using an automated safety surveillance tool to detect early signals that a marketed implantable Cardiac Device was underperforming. Methods and Results—For this purpose, we performed simulated prospective monthly full-cohort and propensity-matched comparative survival analyses on our 3-center database of Sprint Fidelis and Quattro Secure implantable cardioverter-defibrillator leads, using a commercially available automated surveillance tool that was preset to trigger an alert if the log rank probability value was <0.05. During the study, 84 of 1035 Fidelis (8.1%) and 23 of 1675 Quattro (1.4%) leads failed. The simulated full-cohort analysis triggered a sustained alert for Fidelis leads beginning 13 months after the first im...
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Early Detection of an Underperforming Implantable Cardiovascular Device Using an Automated Safety Surveillance Tool
Circulation: Cardiovascular Quality and Outcomes, 2012Co-Authors: Robert G. Hauser, Andrew S. Mugglin, Paul A. Friedman, Daniel B. Kramer, Linda M. Kallinen, Deepa Mcgriff, David L. HayesAbstract:Background—Postmarket medical Device surveillance in the United States depends largely on voluntary reporting of adverse events. Consequently, early safety signals may be missed, exposing patients to potentially hazardous products. The aim of this study was to assess the feasibility of using an automated safety surveillance tool to detect early signals that a marketed implantable Cardiac Device was underperforming. Methods and Results—For this purpose, we performed simulated prospective monthly full-cohort and propensity-matched comparative survival analyses on our 3-center database of Sprint Fidelis and Quattro Secure implantable cardioverter-defibrillator leads, using a commercially available automated surveillance tool that was preset to trigger an alert if the log rank probability value was
Paolo Marzullo - One of the best experts on this subject based on the ideXlab platform.
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Head-to-head comparison of a CZT-based all-purpose SPECT camera and a dedicated CZT Cardiac Device for myocardial perfusion and functional analysis
Journal of Nuclear Cardiology, 2019Co-Authors: Alessia Gimelli, Riccardo Liga, Michelangelo Bertasi, Annette Kusch, Paolo MarzulloAbstract:Purpose To compare the outputs of a novel all-purpose SPECT camera equipped with CZT detectors (Discovery NM/CT 670) with the state-of-the-art represented by a dedicated CZT (Alcyone, Discovery 530c) Cardiac camera in patients submitted to myocardial perfusion imaging (MPI). Methods We included 19 patients that underwent sequential low-dose ^99mTc-tetrofosmin (148-185 MBq during stress and 296-370 MBq at rest) MPI with Alcyone and Discovery 670 cameras. Quantitative (% tracer’s uptake) and semi-quantitative analyses of perfusion data were performed for each scan. Moreover, major left ventricular (LV) functional and structural parameters were derived from each camera and compared. Results The two cameras showed excellent correlation for segmental myocardial % uptake at stress ( R = 0.90; P
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Head-to-head comparison of a CZT-based all-purpose SPECT camera and a dedicated CZT Cardiac Device for myocardial perfusion and functional analysis
Journal of Nuclear Cardiology, 2019Co-Authors: Alessia Gimelli, Riccardo Liga, Michelangelo Bertasi, Annette Kusch, Paolo MarzulloAbstract:Purpose To compare the outputs of a novel all-purpose SPECT camera equipped with CZT detectors (Discovery NM/CT 670) with the state-of-the-art represented by a dedicated CZT (Alcyone, Discovery 530c) Cardiac camera in patients submitted to myocardial perfusion imaging (MPI). Methods We included 19 patients that underwent sequential low-dose ^99mTc-tetrofosmin (148-185 MBq during stress and 296-370 MBq at rest) MPI with Alcyone and Discovery 670 cameras. Quantitative (% tracer’s uptake) and semi-quantitative analyses of perfusion data were performed for each scan. Moreover, major left ventricular (LV) functional and structural parameters were derived from each camera and compared. Results The two cameras showed excellent correlation for segmental myocardial % uptake at stress ( R = 0.90; P
Vincenzo Vullo - One of the best experts on this subject based on the ideXlab platform.
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detection of biofilm associated implant pathogens in Cardiac Device infections high sensitivity of sonication fluid culture even in the presence of antimicrobials
Journal of Global Infectious Diseases, 2018Co-Authors: Alessandra Oliva, M T Mascellino, Bich Lien Nguyen, Massimiliano De Angelis, Alessia Cipolla, Annalisa Di Berardino, Antonio Ciccaglioni, C M Mastroianni, Vincenzo VulloAbstract:Introduction: Sonication showed more sensitivity than traditional culture in the diagnosis of Device infections. Aims of the study were to assess the role of sonication in the microbiological diagnosis and management of Cardiac Device infections (CDIs), to evaluate the sensitivity of sonication in patients on antimicrobial therapy at the time of Device removal, and to analyze biofilm formation of the isolated strains. Materials and Methods: A total of 90 Devices (31 generators and 59 electrodes) collected from 31 patients with infection underwent sonication before culture. Devices were sonicated for 5 min and centrifuged at 3200 rpm for 15 min. Intraoperative traditional cultures were performed in 26 patients. Microorganisms were identified using conventional methods. Staphylococcal strains were tested for slime production. Results: Microbiological diagnosis was achieved in 28 patients (90%). Sonicate fluid was positive in 68/90 (76%) of Devices (27/31 [87%] generators and 41/59 [69%] electrodes), whereas intraoperative pocket swabs grew bacteria in 10/26 patients (38%, P= 0.0007). Among leads, 37/59 (62.7%) yielded bacteria even in the absence of vegetation. Coagulase-negative Staphylococci accounted for 83.8% (57/68) of the total; Staphylococcus aureus and Gram-negative bacilli were found in 4.4% (3/68) and 5.8% (4/68), respectively. Biofilm production was present in 15/22 (69%) staphylococcal strains. Overall, patients on therapy (n = 23) had a microbiological diagnosis in 20/23 (86.9%) and 7/22 (30.4%) through sonication and intraoperative cultures, respectively (P = 0.0002). Discussion: Our data showed the high sensitivity of sonication in the diagnosis of CDIs, even in patients under antimicrobial therapy. Conclusion: Sonication represents an essential tool for both diagnosis and management of CDIs.
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Sonication of Explanted Cardiac Implants Improves Microbial Detection in Cardiac Device Infections
Journal of clinical microbiology, 2012Co-Authors: Alessandra Oliva, M T Mascellino, Bich Lien Nguyen, Antonio Ciccaglioni, Vincenzo Vullo, Alessandra D’abramo, Marco Iannetta, Claudio Maria MastroianniAbstract:The sonication technique has been shown to be a promising tool for microbiological diagnosis of Device-related infections. We evaluated the usefulness of the sonication method for pathogen detection in 80 explanted Cardiac components collected from 40 patients, and the results were compared with those of conventional cultures. Forty subjects undergoing Cardiac Device removal were studied: 20 had Cardiac Device infection, and 20 subjects underwent elective generator replacement or revision in the absence of infection. Sonication of explanted Devices was more sensitive than traditional culture for microbial detection (67% and 50%, respectively; P = 0.0005). The bacterial count detected in sonication fluid culture was significantly higher than that detected in traditional culture in both infected (P = 0.019) and uninfected (P = 0.029) Devices. In the infected patients, sonication fluid culture yielded a significantly higher rate of pathogen detection in explanted electrodes than traditional culture (65% versus 45%; P = 0.02), while no differences were found in the generators. Ten strains were detected only through sonication fluid culture: 6 Staphylococcus epidermidis strains, 1 Staphylococcus hominis strain, 2 Corynebacterium striatum strains, and 1 Brevundimonas sp. Neither the type nor the duration of antimicrobial therapy before Device removal had an effect on the diagnostic performance of sonication fluid culture (P = 0.75 and P = 0.56, respectively). In the patients without infection, sonication fluid culture was positive in 8 cases (40%), whereas conventional culture was positive in only 4 (20%). In summary, the sonication technique improves the microbiological diagnosis of explanted Cardiac Devices.
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Sonication of Explanted Cardiac Implants Improves Microbial Detection in
2012Co-Authors: Alessandra Oliva, M T Mascellino, Bich Lien Nguyen, Antonio Ciccaglioni, Vincenzo Vullo, Marco, Claudio Maria Mastroianni, Polo PontinoAbstract:21 Sonication technique has been shown as a promising tool for microbiological diagnosis of 22 Devices-related infections. We evaluated the usefulness of sonication method for pathogen 23 detection in 80 explanted Cardiac components collected from 40 patients and the results were 24 compared with those of conventional cultures. Forty subjects undergoing Cardiac Device 25 removal were studied: 20 had Cardiac Device infection and 20 subjects underwent elective 26 generator replacement or revision in the absence of infection. Sonication of explanted Devices 27 was more sensitive than traditional culture for microbial detection (67% and 50%, 28 respectively; p=0.0005). The bacterial count in sonicate fluid culture was significantly higher 29 than that detected in traditional culture in both infected (p=0.019) and uninfected Devices 30 (p