The Experts below are selected from a list of 297 Experts worldwide ranked by ideXlab platform
Robert G Hauser - One of the best experts on this subject based on the ideXlab platform.
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transvenous Implantable Cardioverter Defibrillator lead reliability implications for postmarket surveillance
Journal of the American Heart Association, 2015Co-Authors: Deepa Mcgriff, Melanie T Gura, Linda Kallinen Retel, Laura A Hatfield, Christopher R. Ellis, Michelle Samuel-foo, Daniel B Kramer, Robert G HauserAbstract:Background As Implantable Cardioverter‐Defibrillator technology evolves, clinicians and patients need reliable performance data on current transvenous Implantable Cardioverter‐Defibrillator systems. In addition, real‐world reliability data could inform postmarket surveillance strategies directed by regulators and manufacturers. Methods and Results We evaluated Medtronic Sprint Quattro, Boston Scientific Endotak, and St Jude Medical Durata and Riata ST Optim leads implanted by participating center physicians between January 1, 2006 and September 1, 2012. Our analytic sample of 2653 patients (median age 65, male 73%) included 445 St Jude, 1819 Medtronic, and 389 Boston Scientific leads. After a median of 3.2 years, lead failure was 0.28% per year (95% CI, 0.19 to 0.43), with no statistically significant difference among manufacturers. Simulations based on these results suggest that detecting performance differences among generally safe leads would require nearly 10 000 patients or very long follow‐up. Conclusions Currently marketed Implantable Cardioverter‐Defibrillator leads rarely fail, which may be reassuring to clinicians advising patients about risks and benefits of transvenous Implantable Cardioverter‐Defibrillator systems. Regulators should consider the sample size implications when designing comparative effectiveness studies and evaluating new technology for preventing sudden cardiac death.
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longevity of sprint fidelis Implantable Cardioverter Defibrillator leads and risk factors for failure
Circulation, 2011Co-Authors: Robert G Hauser, William H. Maisel, Paul A Friedman, Linda M Kallinen, Andrew S Mugglin, Kapil Kumar, David O Hodge, Thomas B Morrison, David L HayesAbstract:Background—Sprint Fidelis (Fidelis) Implantable Cardioverter-Defibrillator leads are prone to fractures that have caused adverse events, primarily inappropriate shocks, and a few reported deaths. More than 100 000 patients have Fidelis leads. No independent multicenter long-term performance information exists for this lead, and single-center studies suggest that certain patients are at increased risk for Fidelis failure. Our aim was to assess the longevity of Fidelis leads and to evaluate clinical variables and adverse events associated with Fidelis failure. The results were compared with like data for Quattro Secure (Quattro) Implantable Cardioverter-Defibrillator leads implanted at our centers. Methods and Results—This 3-center study included adults ≥18 years of age who received Fidelis or Quattro leads for the prevention of sudden cardiac death. From November 2001 to January 2009,1023 Fidelis and 1668 Quattro leads were implanted and followed up. The failure rate for Fidelis leads was 2.81%/y compared ...
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longevity of sprint fidelis Implantable Cardioverter Defibrillator leads and risk factors for failure implications for patient management
Circulation, 2011Co-Authors: Robert G Hauser, William H. Maisel, Paul A Friedman, Linda M Kallinen, Andrew S Mugglin, Kapil Kumar, David O Hodge, Thomas B Morrison, David L HayesAbstract:Background—Sprint Fidelis (Fidelis) Implantable Cardioverter-Defibrillator leads are prone to fractures that have caused adverse events, primarily inappropriate shocks, and a few reported deaths. More than 100 000 patients have Fidelis leads. No independent multicenter long-term performance information exists for this lead, and single-center studies suggest that certain patients are at increased risk for Fidelis failure. Our aim was to assess the longevity of Fidelis leads and to evaluate clinical variables and adverse events associated with Fidelis failure. The results were compared with like data for Quattro Secure (Quattro) Implantable Cardioverter-Defibrillator leads implanted at our centers. Methods and Results—This 3-center study included adults ≥18 years of age who received Fidelis or Quattro leads for the prevention of sudden cardiac death. From November 2001 to January 2009,1023 Fidelis and 1668 Quattro leads were implanted and followed up. The failure rate for Fidelis leads was 2.81%/y compared ...
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longevity of sprint fidelis Implantable Cardioverter Defibrillator leads and risk factors for failure implications for patient management
Circulation, 2011Co-Authors: Robert G Hauser, William H. Maisel, Paul A Friedman, Linda M Kallinen, Andrew S Mugglin, Kapil Kumar, David O Hodge, Thomas B Morrison, David L HayesAbstract:Background— Sprint Fidelis (Fidelis) Implantable Cardioverter-Defibrillator leads are prone to fractures that have caused adverse events, primarily inappropriate shocks, and a few reported deaths. More than 100 000 patients have Fidelis leads. No independent multicenter long-term performance information exists for this lead, and single-center studies suggest that certain patients are at increased risk for Fidelis failure. Our aim was to assess the longevity of Fidelis leads and to evaluate clinical variables and adverse events associated with Fidelis failure. The results were compared with like data for Quattro Secure (Quattro) Implantable Cardioverter-Defibrillator leads implanted at our centers. Methods and Results— This 3-center study included adults ≥18 years of age who received Fidelis or Quattro leads for the prevention of sudden cardiac death. From November 2001 to January 2009,1023 Fidelis and 1668 Quattro leads were implanted and followed up. The failure rate for Fidelis leads was 2.81%/y compared with 0.43%/y for Quattro leads ( P <0.0001). No deaths or injuries occurred as a result of lead failure, but 42% of fractures caused inappropriate shocks. The survival of Fidelis leads at 4 years was 87.0% (95% confidence interval, 83.6 to 90.1) compared with 98.7% (95% confidence interval, 97.9 to 99.4) for Quattro leads ( P <0.0001). Multivariate predictors of Fidelis failure were younger age (hazard ratio, 0.98; 95% confidence interval, 0.96 to 0.99), female gender (hazard ratio, 0.61; 95% confidence interval, 0.40 to 1.00), and cardiac disease ( P =0.041). Conclusions— Compared with Quattro leads, the survival of Fidelis leads continues to decline, and Fidelis failure is notably higher in younger patients, women, individuals with hypertrophic cardiomyopathy, and patients with arrhythmogenic right ventricular dysplasia or channelopathies. These findings have significant implications for the management of patients who have Fidelis leads, and they demonstrate the importance of weighing clinical variables in assessments of Implantable Cardioverter-Defibrillator lead performance. # Clinical Perspective {#article-title-24}
Manesh R Patel - One of the best experts on this subject based on the ideXlab platform.
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amplatzer vascular plug closure of a subclavian arteriovenous fistula associated with Implantable Cardioverter Defibrillator implantation
Catheterization and Cardiovascular Interventions, 2011Co-Authors: Connie N Hess, Magnus E Ohman, Manesh R PatelAbstract:Subclavian arteriovenous fistula (AVF) is a rare complication of Implantable Cardioverter-Defibrillator (ICD) implantation. This report illustrates the case of a subclavian AVF after ICD implantation in a patient with nonischemic cardiomyopathy and the successful closure of this AVF using an Amplatzer vascular occlusion plug. Given the increasing number of ICD implantations, physicians should be made aware of this uncommon complication. In addition, as more percutaneous endovascular techniques are developed to treat peripheral vascular and structural heart disease, iatrogenic AVFs may occur more frequently. The Amplatzer vascular plug should be considered as a potential treatment strategy for AVFs alongside other endovascular and surgical techniques. © 2011 Wiley-Liss, Inc.
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amplatzer vascular plug closure of a subclavian arteriovenous fistula associated with Implantable Cardioverter Defibrillator implantation
Catheterization and Cardiovascular Interventions, 2011Co-Authors: Connie N Hess, Magnus E Ohman, Manesh R PatelAbstract:Subclavian arteriovenous fistula (AVF) is a rare complication of Implantable Cardioverter-Defibrillator (ICD) implantation. This report illustrates the case of a subclavian AVF after ICD implantation in a patient with nonischemic cardiomyopathy and the successful closure of this AVF using an Amplatzer vascular occlusion plug. Given the increasing number of ICD implantations, physicians should be made aware of this uncommon complication. In addition, as more percutaneous endovascular techniques are developed to treat peripheral vascular and structural heart disease, iatrogenic AVFs may occur more frequently. The Amplatzer vascular plug should be considered as a potential treatment strategy for AVFs alongside other endovascular and surgical techniques.
David L Hayes - One of the best experts on this subject based on the ideXlab platform.
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longevity of sprint fidelis Implantable Cardioverter Defibrillator leads and risk factors for failure
Circulation, 2011Co-Authors: Robert G Hauser, William H. Maisel, Paul A Friedman, Linda M Kallinen, Andrew S Mugglin, Kapil Kumar, David O Hodge, Thomas B Morrison, David L HayesAbstract:Background—Sprint Fidelis (Fidelis) Implantable Cardioverter-Defibrillator leads are prone to fractures that have caused adverse events, primarily inappropriate shocks, and a few reported deaths. More than 100 000 patients have Fidelis leads. No independent multicenter long-term performance information exists for this lead, and single-center studies suggest that certain patients are at increased risk for Fidelis failure. Our aim was to assess the longevity of Fidelis leads and to evaluate clinical variables and adverse events associated with Fidelis failure. The results were compared with like data for Quattro Secure (Quattro) Implantable Cardioverter-Defibrillator leads implanted at our centers. Methods and Results—This 3-center study included adults ≥18 years of age who received Fidelis or Quattro leads for the prevention of sudden cardiac death. From November 2001 to January 2009,1023 Fidelis and 1668 Quattro leads were implanted and followed up. The failure rate for Fidelis leads was 2.81%/y compared ...
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longevity of sprint fidelis Implantable Cardioverter Defibrillator leads and risk factors for failure implications for patient management
Circulation, 2011Co-Authors: Robert G Hauser, William H. Maisel, Paul A Friedman, Linda M Kallinen, Andrew S Mugglin, Kapil Kumar, David O Hodge, Thomas B Morrison, David L HayesAbstract:Background—Sprint Fidelis (Fidelis) Implantable Cardioverter-Defibrillator leads are prone to fractures that have caused adverse events, primarily inappropriate shocks, and a few reported deaths. More than 100 000 patients have Fidelis leads. No independent multicenter long-term performance information exists for this lead, and single-center studies suggest that certain patients are at increased risk for Fidelis failure. Our aim was to assess the longevity of Fidelis leads and to evaluate clinical variables and adverse events associated with Fidelis failure. The results were compared with like data for Quattro Secure (Quattro) Implantable Cardioverter-Defibrillator leads implanted at our centers. Methods and Results—This 3-center study included adults ≥18 years of age who received Fidelis or Quattro leads for the prevention of sudden cardiac death. From November 2001 to January 2009,1023 Fidelis and 1668 Quattro leads were implanted and followed up. The failure rate for Fidelis leads was 2.81%/y compared ...
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longevity of sprint fidelis Implantable Cardioverter Defibrillator leads and risk factors for failure implications for patient management
Circulation, 2011Co-Authors: Robert G Hauser, William H. Maisel, Paul A Friedman, Linda M Kallinen, Andrew S Mugglin, Kapil Kumar, David O Hodge, Thomas B Morrison, David L HayesAbstract:Background— Sprint Fidelis (Fidelis) Implantable Cardioverter-Defibrillator leads are prone to fractures that have caused adverse events, primarily inappropriate shocks, and a few reported deaths. More than 100 000 patients have Fidelis leads. No independent multicenter long-term performance information exists for this lead, and single-center studies suggest that certain patients are at increased risk for Fidelis failure. Our aim was to assess the longevity of Fidelis leads and to evaluate clinical variables and adverse events associated with Fidelis failure. The results were compared with like data for Quattro Secure (Quattro) Implantable Cardioverter-Defibrillator leads implanted at our centers. Methods and Results— This 3-center study included adults ≥18 years of age who received Fidelis or Quattro leads for the prevention of sudden cardiac death. From November 2001 to January 2009,1023 Fidelis and 1668 Quattro leads were implanted and followed up. The failure rate for Fidelis leads was 2.81%/y compared with 0.43%/y for Quattro leads ( P <0.0001). No deaths or injuries occurred as a result of lead failure, but 42% of fractures caused inappropriate shocks. The survival of Fidelis leads at 4 years was 87.0% (95% confidence interval, 83.6 to 90.1) compared with 98.7% (95% confidence interval, 97.9 to 99.4) for Quattro leads ( P <0.0001). Multivariate predictors of Fidelis failure were younger age (hazard ratio, 0.98; 95% confidence interval, 0.96 to 0.99), female gender (hazard ratio, 0.61; 95% confidence interval, 0.40 to 1.00), and cardiac disease ( P =0.041). Conclusions— Compared with Quattro leads, the survival of Fidelis leads continues to decline, and Fidelis failure is notably higher in younger patients, women, individuals with hypertrophic cardiomyopathy, and patients with arrhythmogenic right ventricular dysplasia or channelopathies. These findings have significant implications for the management of patients who have Fidelis leads, and they demonstrate the importance of weighing clinical variables in assessments of Implantable Cardioverter-Defibrillator lead performance. # Clinical Perspective {#article-title-24}
Connie N Hess - One of the best experts on this subject based on the ideXlab platform.
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amplatzer vascular plug closure of a subclavian arteriovenous fistula associated with Implantable Cardioverter Defibrillator implantation
Catheterization and Cardiovascular Interventions, 2011Co-Authors: Connie N Hess, Magnus E Ohman, Manesh R PatelAbstract:Subclavian arteriovenous fistula (AVF) is a rare complication of Implantable Cardioverter-Defibrillator (ICD) implantation. This report illustrates the case of a subclavian AVF after ICD implantation in a patient with nonischemic cardiomyopathy and the successful closure of this AVF using an Amplatzer vascular occlusion plug. Given the increasing number of ICD implantations, physicians should be made aware of this uncommon complication. In addition, as more percutaneous endovascular techniques are developed to treat peripheral vascular and structural heart disease, iatrogenic AVFs may occur more frequently. The Amplatzer vascular plug should be considered as a potential treatment strategy for AVFs alongside other endovascular and surgical techniques. © 2011 Wiley-Liss, Inc.
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amplatzer vascular plug closure of a subclavian arteriovenous fistula associated with Implantable Cardioverter Defibrillator implantation
Catheterization and Cardiovascular Interventions, 2011Co-Authors: Connie N Hess, Magnus E Ohman, Manesh R PatelAbstract:Subclavian arteriovenous fistula (AVF) is a rare complication of Implantable Cardioverter-Defibrillator (ICD) implantation. This report illustrates the case of a subclavian AVF after ICD implantation in a patient with nonischemic cardiomyopathy and the successful closure of this AVF using an Amplatzer vascular occlusion plug. Given the increasing number of ICD implantations, physicians should be made aware of this uncommon complication. In addition, as more percutaneous endovascular techniques are developed to treat peripheral vascular and structural heart disease, iatrogenic AVFs may occur more frequently. The Amplatzer vascular plug should be considered as a potential treatment strategy for AVFs alongside other endovascular and surgical techniques.
Steven P Kutalek - One of the best experts on this subject based on the ideXlab platform.
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increased shock impedance is associated with failed subcutaneous Implantable Cardioverter Defibrillator defibrillation threshold testing
Journal of the American College of Cardiology, 2017Co-Authors: Heath Saltzman, Brett Angel, Jay Overcash, Steven P KutalekAbstract:Background: The Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) is indicated for patients who have a standard indication for a transvenous Implantable Cardioverter Defibrillator (T-ICD) without the need for cardiac pacing. While recent literature questions the utility of defibrillation
