551 results on '"Bruce L. Wilkoff"'
Search Results
2. Heart rate score, a measure related to chronotropic incompetence in pacemaker patients
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Arjun D. Sharma, MD, Mark Richards, MD, PhD, FHRS, Brian Olshansky, MD, FHRS, Nicholas Wold, MS, Paul Jones, MS, David Perschbacher, BS, and Bruce L. Wilkoff, MD, FHRS
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Chronotropic incompetence ,Heart rate score ,Pacemaker ,Risk assessment ,Treadmill testing ,Diseases of the circulatory (Cardiovascular) system ,RC666-701 - Abstract
Background: Heart rate score (HrSc) ≥70% in cardiac resynchronization therapy defibrillator and implantable cardioverter-defibrillator subjects predicts 5-year mortality risk. A high HrSc suggests few sensed cardiac cycles above the programmed lower rate. Objective: To determine if HrSc is related to chronotropic incompetence (CI) in pacemaker (PM) subjects. Methods: HrSc is the percentage of all atrial-paced and sensed events in the single tallest 10 beats/min histogram bin programmed to DDD 60/min. The prospective LIFE study of PM subjects examined multiple treadmill-based measures of CI. The 1-month postimplant DDD 60/min PM rate histogram prior to treadmill was retrospectively analyzed for HrSc. Measures of CI were applied to submaximal treadmill data in the DDD mode. HrSc was compared to these CI measures and to clinical indications for PM. Results: The 1-month histogram demonstrated HrSc ≥70% in 43% of subjects. HrSc ≥70% correlated with a clinical diagnosis of sick sinus syndrome (P < .001). CI was present in 34%–88% of subjects by treadmill-based measures. Agreement between treadmill-based measures for CI was poor and varied from 39% to 83%. HrSc ≥70%, as a measure of CI, was most highly correlated with unpaced heart rate
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- 2021
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3. Differences in clinical characteristics and reported quality of life of men and women undergoing cardiac resynchronization therapy
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Bruce L. Wilkoff, David Birnie, Michael R. Gold, Ahmad S. Hersi, Sandra Jacobs, Bart Gerritse, Kengo Kusano, Christophe Leclercq, Wilfried Mullens, and Gerasimos Filippatos
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Cardiac resynchronization therapy outcome ,LV pacing ,AV conduction ,Left bundle branch block ,Gender differences in heart failure ,Kansas City Cardiomyopathy Questionnaire ,Diseases of the circulatory (Cardiovascular) system ,RC666-701 - Abstract
Abstract Aims Response to cardiac resynchronization therapy (CRT) is known to be associated with a number of clinical characteristics, including QRS duration and morphology, gender, height, and the aetiology of heart failure (HF). We assessed the relation of gender and baseline characteristics with QRS duration and Kansas City Cardiomyopathy Questionnaire. Methods and results AdaptResponse is a global randomized trial. The trial enrolled CRT‐indicated patients with New York Heart Association classes II–IV HF, left bundle branch block (QRS ≥ 140 ms in men, ≥130 ms in women), and baseline PR interval ≤200 ms. In total, 3620 patients were randomized, including 1569 women (43.3%) approaching the actual proportion of women in the HF population. Women were older and more often New York Heart Association class III or IV than men (55.6% vs. 48.7%), had less frequent ischaemic cardiomyopathy (21.2% vs. 39.5%), and had a 5.1 ms shorter QRS duration than men. Women were more often depressed (18.5% vs. 9.7%), had a significantly lower Kansas City Cardiomyopathy Questionnaire score, and had differences in medication prescriptions. Conclusions AdaptResponse is the largest randomized CRT trial and enrolled more women than any other landmark CRT trial. Women differed from men with regard to baseline characteristics and quality of life. Whether these differences translate into clinical outcome differences will be examined further in the AdaptResponse trial.
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- 2020
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4. 2019 HRS/EHRA/APHRS/LAHRS focused update to 2015 expert consensus statement on optimal implantable cardioverter‐defibrillator programming and testing
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Martin K. Stiles, Laurent Fauchier, Carlos A. Morillo, and Bruce L. Wilkoff
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Antitachycardia pacing ,Bradycardia mode and rate ,Defibrillation testing ,Implantable cardioverter‐defibrillator ,Programming ,Sudden cardiac death ,Diseases of the circulatory (Cardiovascular) system ,RC666-701 - Abstract
Abstract The 2015 HRS/EHRA/APHRS/SOLAECE Expert Consensus Statement on Optimal Implantable Cardioverter‐Defibrillator Programming and Testing provided guidance on bradycardia programming, tachycardia detection, tachycardia therapy, and defibrillation testing for implantable cardioverter‐defibrillator (ICD) patient treatment. The 32 recommendations represented the consensus opinion of the writing group, graded by Class of Recommendation and Level of Evidence. In addition, Appendix B provided manufacturer‐specific translations of these recommendations into clinical practice consistent with the recommendations within the parent document. In some instances, programming guided by quality evidence gained from studies performed in devices from some manufacturers was translated such that this programming was approximated in another manufacturer's ICD programming settings. The authors found that the data, although not formally tested, were strong, consistent, and generalizable beyond the specific manufacturer and model of ICD. As expected, because these recommendations represented strategic choices to balance risks, there have been reports in which adverse outcomes were documented with ICDs programmed to Appendix B recommendations. The recommendations have been reviewed and updated to minimize such adverse events. Notably, patients who do not receive unnecessary ICD therapy are not aware of being spared potential harm, whereas patients in whom their ICD failed to treat life‐threatening arrhythmias have their event recorded in detail. The revised recommendations employ the principle that the randomized trials and large registry data should guide programming more than anecdotal evidence. These recommendations should not replace the opinion of the treating physician who has considered the patient's clinical status and desired outcome via a shared clinical decision‐making process.
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- 2019
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5. 2015 HRS/EHRA/APHRS/SOLAECE expert consensus statement on optimal implantable cardioverter-defibrillator programming and testing
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Bruce L. Wilkoff, MD, FHRS, CCDS, Laurent Fauchier, MD, PhD, Martin K. Stiles, MBCHB, PhD, Carlos A. Morillo, MD, FRCPC, FHRS, Sana M. Al-Khatib, MD, MHSc, FHRS, CCDS, Jesœs Almendral, MD, PhD, FESC, Luis Aguinaga, MD, PhD, FACC, FESC, Ronald D. Berger, MD, PhD, FHRS, Alejandro Cuesta, MD, PhD, FESC, James P. Daubert, MD, FHRS, Sergio Dubner, MD, FACC, Kenneth A. Ellenbogen, MD, FHRS, N.A. Mark Estes, III, MD, Guilherme Fenelon, MD, PhD, Fermin C. Garcia, MD, Maurizio Gasparini, MD, David E. Haines, MD, FHRS, Jeff S. Healey, MD, MSc, FRCPC, FHRS, Jodie L. Hurtwitz, MD, Roberto Keegan, MD, Christof Kolb, MD, Karl-Heinz Kuck, MD, FHRS, Germanas Marinskis, MD, FESC, Martino Martinelli, MD, PhD, Mark McGuire, MBBS, PhD, Luis G. Molina, MD, DSc, Ken Okumura, MD, PhD, Alessandro Proclemer, MD, Andrea M. Russo, MD, FHRS, Jagmeet P. Singh, MD, DPhil, FHRS, Charles D. Swerdlow, MD, FHRS, Wee Siong Teo, MBBS, FHRS, William Uribe, MD, FHRS, Sami Viskin, MD, Chun-Chieh Wang, MD, and Shu Zhang, MD
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Implantable cardioverter-defibrillator ,Bradycardia mode and rate ,Tachycardia detection ,Tachycardia therapy ,Defibrillation testing ,Programming ,Diseases of the circulatory (Cardiovascular) system ,RC666-701 - Published
- 2016
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6. How to diagnose and manage patients with cardiac implantable electronic device infections
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Khaldoun G. Tarakji and Bruce L. Wilkoff
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Cardiac implantable electronic device (CIED) ,Pacemaker ,Defibrillator ,Infection ,Endocarditis ,Diseases of the circulatory (Cardiovascular) system ,RC666-701 - Abstract
Abstract Over the last two decades, there has been a surge in the number of Cardiac Implantable Electronic Device (CIED) implantation. These devices improve the quality of life and survival among certain cardiac patients. However, this benefit might be affected by device complications and one of the most important ones is CIED infection as it carries significant morbidity and mortality. CIED infection can present as a device pocket infection or endovascular infection and its diagnosis could be challenging. In general, management of CIED infection involves device removal and antibiotic therapy and requires collaboration between different clinical teams. Future efforts and research should focus on measures to prevent the occurrence of this outcome.
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- 2013
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7. Successful stent implantation for superior vena cava injury during transvenous lead extraction
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Xiaoying Lou, BS, Michael P. Brunner, MD, Bruce L. Wilkoff, MD, FHRS, David O. Martin, MD, MPH, Daniel G. Clair, MD, and Edward G. Soltesz, MD, MPH
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Implantable cardioverter-defibrillator ,Laser lead extraction ,Superior vena cava injury ,Stenting ,Diseases of the circulatory (Cardiovascular) system ,RC666-701 - Published
- 2015
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8. Cardiac resynchronization therapy for exercise-induced left ventricular dysfunction in the setting of left bundle branch block: A case report and review of the literature
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JoEllyn M. Abraham, MD, James D. Thomas, MD, and Bruce L. Wilkoff, MD
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Cardiac resynchronization therapy ,Left bundle branch block ,Diseases of the circulatory (Cardiovascular) system ,RC666-701 - Abstract
Exercise-induced dyspnea is one of the most common symptoms that cause a patient to see a physician and a broad differential diagnosis is required. In this case report, we describe a patient with this complaint who had a left bundle branch block and preserved left ventricular function at rest. On stress echocardiography, she had significant exercise-induced left ventricular dysfunction and associated mitral regurgitation but a coronary angiogram demonstrated normal coronary arteries. Both of the echocardiographic findings, as well as her symptoms, improved with the placement of a bi-ventricular pacemaker. A brief review of the literature on cardiac resynchronization therapy for indications beyond the current guidelines is also provided.
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- 2014
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9. Magnetic Resonance Imaging Conditional Pacemakers: Rationale, Development and Future Directions
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Edmond M. Cronin, MB, MRCPI and Bruce L. Wilkoff, MD, FHRS, CCDS
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magnetic resonance imaging (MRI) ,cardiovascular implantable electronic device (CIED) ,pacemaker ,implantable cardioverter-defibrillator (ICD) ,Diseases of the circulatory (Cardiovascular) system ,RC666-701 - Abstract
Pacemakers and other cardiac implantable electronic devices (CIEDs) have long been considered an absolute contraindication to magnetic resonance imaging (MRI), a crucial and growing imaging modality. In the last 20 years, protocols have been developed to allow MR scanning of CIED patients with a low complication rate. However, this practice has remained limited to a relatively small number of centers, and many pacemaker patients continue to be denied access to clinically indicated imaging. The introduction of MRI conditional pacemakers has provided a widely applicable and satisfactory solution to this problem. Here, the interactions of pacemakers with the MR environment, the results of MR scanning in patients with conventional CIEDs, the development and clinical experience with MRI conditional devices, and future directions are reviewed.
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- 2012
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10. Erratum to ‘2015 HRS/EHRA/APHRS/SOLAECE expert consensus statement on optimal implantable cardioverter-defibrillator programming and testing’ [Journal of Arrhythmia 32/1 (2016) 1–28]
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Bruce L. Wilkoff, MD, FHRS, CCDS, Laurent Fauchier, MD, PhD, Martin K. Stiles, MBCHB, PhD, Carlos A. Morillo, MD, FRCPC, FHRS, Sana M. Al-Khatib, MD, MHSc, FHRS, CCDS, Jesœs Almendral, MD, PhD, FESC, Luis Aguinaga, MD, PhD, FACC, FESC, Ronald D. Berger, MD, PhD, FHRS, Alejandro Cuesta, MD, PhD, FESC, James P. Daubert, MD, FHRS, Sergio Dubner, MD, FACC, Kenneth A. Ellenbogen, MD, FHRS, N.A. Mark Estes, III, MD, Guilherme Fenelon, Fermin C. Garcia, MD, Maurizio Gasparini, MD, David E. Haines, MD, FHRS, Jeff S. Healey, MD, MSc, FRCPC, FHRS, Jodie L. Hurtwitz, MD, Roberto Keegan, MD, Christof Kolb, MD, Karl-Heinz Kuck, MD, FHRS, Germanas Marinskis, MD, FESC, Martino Martinelli, MD, PhD, Mark McGuire, MBBS, PhD, Luis G. Molina, MD, DSc, Ken Okumura, MD, PhD, Alessandro Proclemer, MD, Andrea M. Russo, MD, FHRS, Jagmeet P. Singh, MD, DPhil, FHRS, Charles D. Swerdlow, MD, FHRS, Wee Siong Teo, MBBS, FHRS, William Uribe, MD, FHRS, Sami Viskin, MD, Chun-Chieh Wang, MD, and Shu Zhang, MD
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Diseases of the circulatory (Cardiovascular) system ,RC666-701 - Published
- 2016
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11. Clinical predictors of incomplete coronary sinus lead removal during transvenous lead extraction in patients with cardiac resynchronization therapy
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Katsuhide Hayashi, Arwa Younis, Thomas Callahan, Bryan Baranowski, David O. Martin, Shady Nakhla, and Bruce L. Wilkoff
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Physiology (medical) ,Cardiology and Cardiovascular Medicine - Published
- 2023
12. Mechanics of lumenless pacing lead strength during extraction procedures based on laboratory bench testing
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Pierce J. Vatterott, Blandine Mondésert, Mark Marshall, Thomas Lulic, and Bruce L. Wilkoff
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Physiology (medical) ,Cardiology and Cardiovascular Medicine - Published
- 2023
13. Cardiac Implantable Electronic Devices and Infective Endocarditis
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Ayman A. Hussein, Oussama M. Wazni, and Bruce L. Wilkoff
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Cardiology and Cardiovascular Medicine - Published
- 2023
14. Risk factors for hematoma in patients undergoing cardiac device procedures: A WRAP-IT trial analysis
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Khaldoun G. Tarakji, Panagiotis Korantzopoulos, Francois Philippon, Mauro Biffi, Suneet Mittal, Jeanne E. Poole, Charles Kennergren, Daniel R. Lexcen, Jeff D. Lande, Gregory Hilleren, Swathi Seshadri, and Bruce L. Wilkoff
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Cardiology and Cardiovascular Medicine - Abstract
Implant site hematoma is a known complication of cardiac device procedures and can lead to major consequences.To evaluate risk factors for hematoma and further understand the relationship between anticoagulant (AC), antiplatelet (AP) use, and hematoma development.We included 6800 patients from the WRAP-IT trial. To assess baseline and procedural characteristics associated with hematoma within the first 30 days postprocedure, a stepwise Cox regression model was implemented with minimal Akaike information criterion. Cox regressions were also used to evaluate AC/AP use and hematoma risk.The overall rate of hematoma was 2.2%. The model identified 11 baseline and procedural characteristics associated with hematoma risk. AC use (hazard ratio [HR]: 2.44,The results of this analysis highlight risk factors associated with the development of hematoma in patients undergoing CIED procedures and can inform antithrombotic management.
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- 2022
15. Successful defibrillation by modifying from fixed-tilt to tuned-duration defibrillation waveform: When less is more?
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Katsuhide Hayashi, Takuo Tsurugi, Junjiroh Koyama, Ken Okumura, Haruhiko Abe, and Bruce L. Wilkoff
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Cardiology and Cardiovascular Medicine - Published
- 2022
16. Extraction of a 5-year-old leadless pacemaker using a competing manufacturer’s removal tool
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Thomas D. Callahan and Bruce L. Wilkoff
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Cardiology and Cardiovascular Medicine - Published
- 2023
17. Algorithms and programming matters: implantable cardioverter defibrillator therapy in Biotronik and Abbott devices
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Arwa Younis and Bruce L. Wilkoff
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Physiology (medical) ,Cardiology and Cardiovascular Medicine - Published
- 2023
18. Implantable Cardioverter-Defibrillator for Primary Prevention in Asia
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Arwa Younis and Bruce L. Wilkoff
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Cardiology and Cardiovascular Medicine - Published
- 2023
19. A Shocking Case of Pacemaker Lead Perforation
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Eli Simsolo and Bruce L. Wilkoff
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Cardiology and Cardiovascular Medicine - Published
- 2022
20. Leadless pacing in patients undergoing transvenous lead extraction due to infection: A small step in a long journey
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Arwa Younis and Bruce L. Wilkoff
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Physiology (medical) ,Cardiology and Cardiovascular Medicine - Published
- 2023
21. Novel ventricular tachyarrhythmia detection enhancement detects undertreated life-threatening arrhythmias
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Michael S. Katcher, Jennifer Rhude, Gaurav A. Upadhyay, Peter Seizer, Avi Fischer, Kevin Davis, Bruce L. Wilkoff, Laurence D. Sterns, and Chaoyi Kang
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Arrhythmia detection ,medicine.medical_specialty ,Monomorphic Ventricular Tachycardia ,business.industry ,Ventricular Tachyarrhythmias ,medicine.medical_treatment ,Implantable cardioverter-defibrillator ,medicine.disease ,Internal medicine ,Ventricular fibrillation ,medicine ,Cardiology ,Detection rate ,Cardiology and Cardiovascular Medicine ,business ,Normal Sinus Rhythm - Abstract
Background Ventricular tachyarrhythmias (VTA) with low and varying signal amplitudes and morphologies may not be successfully identified utilizing traditional implantable cardioverter defibrillator algorithms. Objective Develop and validate a novel algorithm (VF Therapy Assurance, VFTA) to improve detection and timely delivery of high voltage therapy (HVT) for these arrhythmias. Method Arrhythmia detection was simulated on recorded VTA electrograms (EGMs) utilizing Abbott's Merlin.net database. EGMs where an HVT occurred only when VFTA was enabled, or where VFTA provided an HVT >30 seconds earlier than without VFTA were re-adjudicated with physician review. As VFTA never prevents detection or therapy, EGMs where VFTA didn't activate or alter HVT were not adjudicated. Results Among 564,353 recorded VTA EGMs from 20,000 devices, VFTA altered HVT in 105 EGMs from 67 devices. Physician adjudication determined that 81.9% (86/105) of these EGMs were true undertreated VTA episodes and would have received appropriate HVT with VFTA enabled. Furthermore, 65% (56/86) of the episodes were ventricular fibrillation, polymorphic, did not self-terminate during the recording window, or not amenable anti-tachycardia pacing. 87.5% (49/56) would not have elicited HVT without VFTA. Overall, VFTA provided new or earlier appropriate HVT in 0.27% (53/20,000) of devices with an increase in inappropriate HVT in 0.07% (14/20,000) devices. Conclusion The VFTA algorithm successfully identifies VTA missed by traditional detection algorithms, due to undersensed ventricular signals resulting in rate falling below the programmed detection rate. The use of VFTA increases the likelihood of delivering life-saving HVT.
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- 2022
22. Risk Factors for CIED Infection After Secondary Procedures
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Mauro Biffi, Daniel R. Lexcen, Paolo Dallaglio, Andrew D. Krahn, Bruce L. Wilkoff, Gregory Hilleren, Reece Holbrook, Jeff D. Lande, Charles Kennergren, Suneet Mittal, Jeanne E. Poole, Khaldoun G. Tarakji, and Panagiotis Korantzopoulos
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medicine.medical_specialty ,business.industry ,medicine.medical_treatment ,Cardiac resynchronization therapy ,Infections ,Implantable cardioverter-defibrillator ,Infeccions ,Desfibril·ladors cardioversors implantables ,medicine ,Background risk ,Infection ,Intensive care medicine ,business ,Implantable cardioverter-defibrillators - Abstract
OBJECTIVES This study aimed to identify risk factors for infection after secondary cardiac implantable electronic device (CIED) procedures. BACKGROUND Risk factors for CIED infection are not well defined and techniques to minimize infection lack supportive evidence. WRAP-IT (World-wide Randomized Antibiotic Envelope Infection Prevention trial), a large study that assessed the safety and efficacy of an antibacterial envelope for CIED infection reduction, offers insight into procedural details and infection prevention strategies. METHODS This analysis included 2,803 control patients from the WRAP-IT trial who received standard preoperative antibiotics but not the envelope (44 patients with major infections through all follow-up). A multivariate least absolute shrinkage and selection operator machine learning model, controlling for patient characteristics and procedural variables, was used for risk factor selection and identification. Risk factors consistently retaining predictive value in the model (appeared >10 times) across 100 iterations of imputed data were deemed significant. RESULTS Of the 81 variables screened, 17 were identified as risk factors with 6 being patient/device-related (nonmodifiable) and 11 begin procedure-related (potentially modifiable). Patient/device-related factors included higher number of previous CIED procedures, history of atrial arrhythmia, geography (outside North America and Europe), device type, and lower body mass index. Procedural factors associated with increased risk included longer procedure time, implant location (non-left pectoral subcutaneous), perioperative glycopeptide antibiotic versus nonglycopeptide, anticoagulant, and/or antiplatelet use, and capsulectomy. Factors associated with decreased risk of infection included chlorhexidine skin preparation and antibiotic pocket wash. CONCLUSIONS In WRAP-IT patients, we observed that several procedural risk factors correlated with infection risk. These results can help guide infection prevention strategies to minimize infections associated with secondary CIED procedures. (J Am Coll Cardiol EP 2022;8:101-111) (c) 2022 The Authors. Published by Elsevier on behalf of the American College of Cardiology Foundation. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).
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- 2022
23. Initial Heart Rate Score Predicts New Onset Atrial Fibrillation in Pacemaker Patients
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Katsuhide Hayashi, Haruhiko Abe, Brian Olshansky, Arjun D. Sharma, Paul W. Jones, Nickolas Wold, David Perschbacher, Ritsuko Kohno, Mark Richards, and Bruce L. Wilkoff
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BackgroundHeart Rate Score (HRSc), the percent of all atrial paced and sensed event in the largest 10 bpm rate histogram bin of a pacemaker, predicts survival in patients with cardiac devices. No correlation between HRSc and development of atrial fibrillation (AF) has been reported.ObjectiveTo evaluate the relationship between pacemaker post-implantation HRSc and newly-developed AF incidence.MethodsPatients with dual-chamber pacemakers, implanted 2013-2017, with ALTITIUDE remote monitoring data with ≥600,000 beats of histogram data collected at baseline were included (N=34,543). HRSc was determined from the post-implantation histogram data during the initial 3 months. Patients were excluded if they had AF, defined as atrial high-rate episodes >5 minutes or >1% of right atrial beats >170 bpm during the initial 3-months post-implantation. New AF, after the baseline period, was defined by each of the following: >1%, >10% or >25% of atrial beats >170 bpm or Atrial Tachycardia Response (ATR) events >24 hr.ResultsPatients were followed a median of 2.8 (1.0-4.0) years. Patients with initial HRSc≥70% were older, had higher %RA pacing, had lower %RV pacing and were more likely programmed with rate-response vs subjects with HRScConclusionHRSc predicts subsequent AF independent of well-known risk factors in pacemaker patients.
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- 2023
24. Influence of 'high' defibrillation thresholds on patient survival and impact of system modification
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Najmul Siddiqi, Patrick Tchou, Mark J. Niebauer, Bruce L. Wilkoff, and Niraj Varma
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Physiology (medical) ,Ventricular Fibrillation ,Electric Countershock ,Humans ,Arrhythmias, Cardiac ,Cardiology and Cardiovascular Medicine ,Defibrillators, Implantable - Abstract
To test whether a high defibrillation threshold (DFT) marks patients with poor outcomes which are improved when DFT is decreased by system modification (subcutaneous coil implant; SM).The electrical substrate generating fast ventricular arrhythmias may generate poor outcomes among patients treated with implantable cardioverter-defibrillators (ICDs), even when arrhythmias are treated successfully. Since patients with high DFTs have increased mortality, we contrasted survival among patients with high DFT treated with and without SM.We studied consecutive patients undergoing ICD implantation and DFT testing at Cleveland Clinic over a 14-year period. High DFT was defined as successful defibrillation by shock strength25 J or ≤10 J of maximal device output. Mortality was recorded using the Social Security Death Index. Survival was compared among those high DFT patients receiving SM versus the remainder.Out of 6353 patients tested, 191 (3%) had high DFT (32.1 ± 3.7 J) versus 13.9 ± 4.9 J in the remainder ("acceptable DFT," p .001). One hundred twenty-one high DFT patients (63%; 33.3 ± 3.4 J) underwent SM, which significantly decreased DFT (24.8 ± 5.9 J; p .001). Seventy patients (37%; 30.3 ± 3.3 J) did not undergo SM. During follow-up, 38% (2363/6162; 7.8 yrs) patients with acceptable DFT died versus 48% high DFT patients (91/191; 5.6 yrs.; p .001). Concomitantly, 48% patients with SM (58/121) died, as compared to 47% patients (33/70) without SM (p = .91); median follow-up 4.9 yrs).Patients with high DFT have a higher mortality than those with acceptable DFT. The additional subcutaneous coil implant decreases DFT to an acceptable range but does not appear to improve survival. The electrical substrate underlying high DFT appears to determine survival.
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- 2021
25. PO-02-061 RAIL STRENGTH BENCH TEST EVALUATION OF LUMENLESS LEADS PREP METHODS
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Pierce J. Vatterott, Mark T. Marshall, Blandine A. Mondesert, Thomas Lulic, Taylor A. Noble, and Bruce L. Wilkoff
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Physiology (medical) ,Cardiology and Cardiovascular Medicine - Published
- 2023
26. Cardiac resynchronisation therapy in anthracycline-induced cardiomyopathy
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Mohamed Kanj, David M. Nemer, Divyang Patel, Ayman A. Hussein, Khaldoun G. Tarakji, Bruce L. Wilkoff, Anirudh Kumar, Daniel J. Cantillon, Trejeeve Martyn, Bryan Baranowski, Zachary J. Il'Giovine, Randall C. Starling, Thomas Callahan, Niraj Varma, Eoin Donnellan, W.H. Wilson Tang, Laurie Ann Moennich, Kevin Trulock, John Rickard, and Oussama M. Wazni
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medicine.medical_specialty ,Anthracycline ,Population ,Cardiomyopathy ,Ventricular Function, Left ,Cardiac Resynchronization Therapy ,Ventricular Dysfunction, Left ,Internal medicine ,Humans ,Medicine ,Anthracyclines ,cardiovascular diseases ,education ,Aged ,Retrospective Studies ,Heart Failure ,Retrospective review ,education.field_of_study ,Ejection fraction ,Ventricular Remodeling ,business.industry ,Cancer ,Stroke Volume ,Mean age ,Middle Aged ,medicine.disease ,Defibrillators, Implantable ,Treatment Outcome ,Heart failure ,cardiovascular system ,Cardiology ,Cardiomyopathies ,Cardiology and Cardiovascular Medicine ,business - Abstract
IntroductionChemotherapy-induced cardiomyopathy has been increasingly recognised as patients are living longer with more effective treatments for their malignancies. Anthracyclines are known to cause left ventricular (LV) dysfunction. While heart failure medications are frequently used, some patients may need consideration for device-based therapies such as cardiac resynchronisation therapy (CRT). However, the role of CRT in anthracycline-induced cardiomyopathy (AIC) is not well understood.MethodsWe performed a retrospective review of all patients undergoing CRT implantation at our centre from 2003 to 2019 with a diagnosis of AIC. The LV remodelling and survival outcomes of this population were obtained and then compared with consecutive patients with other aetiologies of non-ischaemic cardiomyopathy (NICM).ResultsA total of 34 patients underwent CRT implantation with a diagnosis of AIC with a mean age of 60.5±12.7 years, left ventricular ejection fraction (LVEF) of 21.7%±7.4%, and 11.3±7.5 years and 10.2±7.4 years from cancer diagnosis and last anthracycline exposure, respectively. At 9.6±8.1 months after CRT implantation, there was an increase of LVEF from 21.8%±7.6% to 30.4%±13.0% (pConclusionsPatients with AIC undergo LV remodelling with CRT at rates similar to other aetiologies of NICM. Furthermore, AIC post-CRT responders have a favourable long-term mortality compared with non-responders.
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- 2021
27. Predictors of Cardiac Implantable Electronic Device Artifact on Cardiac MRI: The Utility of a Device Related Score
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Scott D. Flamm, Deborah H Kwon, Duygu Kocyigit, Bruce L. Wilkoff, Mostafa Abozeed, and Christine Jellis
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Male ,Pulmonary and Respiratory Medicine ,medicine.medical_specialty ,Image quality ,medicine.medical_treatment ,Contrast Media ,Gadolinium ,030204 cardiovascular system & hematology ,03 medical and health sciences ,0302 clinical medicine ,Cardiac magnetic resonance imaging ,medicine ,Humans ,In patient ,030212 general & internal medicine ,Lead (electronics) ,Retrospective Studies ,Artifact (error) ,medicine.diagnostic_test ,business.industry ,Retrospective cohort study ,Implantable cardioverter-defibrillator ,Magnetic Resonance Imaging ,Defibrillators, Implantable ,medicine.anatomical_structure ,Ventricle ,Female ,Radiology ,Electronics ,Artifacts ,Cardiology and Cardiovascular Medicine ,business - Abstract
Cardiac magnetic resonance imaging (CMR) image quality can be degraded by artifact in patients with cardiac implantable electronic devices (CIED). We aimed to establish a clinical risk score, so patient selection for diagnostic CMR could be optimised.In this retrospective cohort study, CMRs performed for clinical use in subjects with CIED from January 2016 to May 2019 were reviewed. Subject anthropometry, CIED generator/lead specifications and pre-scan chest X-ray (CXR) measurements were collected. Generator-related artifact size was measured on axial steady state free precession images. Interpretability of late gadolinium enhancement (LGE) imaging was performed based on a three-grade visual score attributed to each of 17 myocardial segments.Fifty-seven (57) patients (59±16 years, 74% male) fitted the inclusion criteria. Artifact precluded left ventricle (LV) evaluation (≥5 segments) in 17 (30%). Artifact was more common with implantable cardioverter-defibrillators, related to generator volume, mass, height, width, thickness, and area, along with right ventricular (RV) lead length and diameter (all p0.05). Artifact was associated with distance from generator to LV apex, generator to RV lead tip and shortest distance from generator to heart on CXR (all p0.05). On multivariable regression modelling, RV lead diameter (OR 5.861, 95% CI 1.866-18.407, p=0.002) and distance from generator to LV apex (OR 0.693, 95% CI 0.511-0.940, p=0.019) were independent predictors of artifact. Multivariable predictors were used to develop Device Related CMR Artifact Prediction Score (DR-CAPS), where all patients with DR-CAPS=0 had fully interpretable LGE imaging.Simple, readily available measures, such as lead characteristics and pre-scan CXR measures, can stratify patients via an artifact prediction score to optimise selection for diagnostic CMR.
- Published
- 2021
28. New atrial arrhythmia occurrence in single chamber implantable cardioverter defibrillator patients: A real-world investigation
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Divyang Patel, Archana Rao, Paul A. Friedman, Abhishek J. Deshmukh, Jeff Lande, Jeffrey A. Murphy, Mark L. Brown, Daniel R. Lexcen, and Bruce L. Wilkoff
- Subjects
Physiology (medical) ,Cardiology and Cardiovascular Medicine - Abstract
A current limitation of single chamber implantable cardioverter defibrillators (ICDs) is the lack of an atrial lead to reliably detect atrial fibrillation (AF) episodes. A novel ventricular based atrial fibrillation (VBAF) detection algorithm was created for single chamber ICDs to assess R-R variability for detection of AF.Patients implanted with Visia AF™ ICDs were prospectively enrolled in the Medtronic Product Surveillance Registry from December 15, 2015 to January 23, 2019 and followed with at least 30 days of monitoring with the algorithm. Time to device-detected daily burden of AF ≥ 6 min, ≥6 h, and ≥23 h were reported. Clinical actions after device-detected AF were recorded.A total of 291 patients were enrolled with a mean follow-up of 22.5 ± 7.9 months. Of these, 212 (73%) had no prior history of AF at device implant. However, 38% of these individuals had AF detected with the VBAF algorithm with daily burden of ≥6 min within two years of implant. In these 80 patients with newly detected AF by their ICD, 23 (29%) had a confirmed clinical diagnosis of AF by their provider. Of patients with a clinical diagnosis of AF, nine (39%) were newly placed on anticoagulation, including five of five (100%) patients having a burden23 h.Continuous AF monitoring with the new VBAF algorithm permits early identification and actionable treatment for patients with undiagnosed AF that may improve patient outcomes.
- Published
- 2022
29. Prospective Evaluation of the Correlation Between Gated Cardiac Computed Tomography Detected Vascular Fibrosis and Ease of Transvenous Lead Extraction
- Author
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Divyang Patel, Pierce Vatterott, Jonathan Piccini, Laurence M. Epstein, Samer Hakmi, Imran Syed, Lynne M. Koweek, Michael Bolen, Paul Schoenhagen, Khaldoun G. Tarakji, Nathan Francis, Mingyuan Shao, and Bruce L. Wilkoff
- Subjects
Physiology (medical) ,Cardiology and Cardiovascular Medicine - Abstract
Background: Difficulty of lead extraction does not track well with procedural complications, but several small retrospective studies have lead fibrosis on computed tomography as an important indicator of difficult lead extraction. The purpose of the present study was to apply a standardized gated cardiac computed tomography (CT) protocol to assess fibrosis and study it prospectively to examine the need for powered sheaths and risk outcomes. Methods: We performed a prospective, blinded, multicenter, international study at high-volume lead extraction centers and included patients referred for transvenous lead extraction with at least one lead with a dwell time >1 year and ability to receive a cardiac CT. The degree of fibrosis (as measured by amount of lead adherence to vessel wall) was graded on a scale of 1 to 4 by dedicated CT readers in 3 zones (vein entry to superior vena cava, superior vena cava, and right atrium to lead tip). The primary outcome of the study was number of extractions requiring powered sheaths at zone 2 for each fibrosis group. Results: A total of 200 patients were enrolled in the trial with 196 completing full gated CT and lead extraction analysis. The primary endpoint of powered sheath (laser and mechanical) sheath use was significantly higher in patients with higher fibrosis seen on CT (scores 3+4; 67.8%) at the zone 2 compared to patients with lower fibrosis (scores 1+2; 38.6%; P Conclusions: Gated, contrasted CT can predict the need for powered sheaths by identification of fibrosis but did not identify an absolute low-risk cohort who would not need powered sheaths. Registration: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT03772704.
- Published
- 2022
30. Cost-Effectiveness Analyses of an Absorbable Antibacterial Envelope for Use in Patients at Increased Risk of Cardiac Implantable Electronic Device Infection in Germany, Italy, and England
- Author
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Giuseppe Boriani, Andreas Goette, Fozia Z Ahmed, Charles Kennergren, Michelle Green, Judith Shore, Bruce L. Wilkoff, Mauro Biffi, Phuong Lien Carion, Janet M. McComb, Khaldoun G. Tarakji, David Wright, and Thomas Blum
- Subjects
Pacemaker, Artificial ,medicine.medical_specialty ,medicine.drug_class ,Cost effectiveness ,Cost-Benefit Analysis ,Antibiotics ,Context (language use) ,cardiac implantable electronic device ,law.invention ,03 medical and health sciences ,0302 clinical medicine ,Randomized controlled trial ,law ,Internal medicine ,medicine ,Humans ,Infection control ,030212 general & internal medicine ,Infection Control ,Cost–utility analysis ,antibacterial envelope ,business.industry ,030503 health policy & services ,Health Policy ,Risk of infection ,Decision Trees ,cost-utility analysis ,Public Health, Environmental and Occupational Health ,Antibiotic Prophylaxis ,infection ,Europe ,randomized controlled trial ,0305 other medical science ,business ,Envelope (motion) - Abstract
Objectives To model the cost-effectiveness of the TYRX Absorbable Antibacterial Envelope when used in patients at increased risk of cardiac implantable electronic device (CIED) infection in the context of 3 European healthcare systems: Germany, Italy, and England. Methods A decision tree model with a lifetime horizon was populated using data from the Worldwide Randomized Antibiotic Envelope Infection Prevention Trial, a large multicenter randomized controlled trial. Use of the antibacterial envelope adjunctive to standard of care was compared to standard of care infection prevention alone. Patients in the model were divided into subgroups based on presence of factors known to increase infection risk. Results The antibacterial envelope had the most favorable cost-effectiveness profile when patients had previously experienced CIED infection, had a history of immunosuppressive therapy, or had a Prevention of Arrhythmia Device Infection Trial (PADIT) score indicating high risk of infection (scores ≥6) at cost-effectiveness thresholds of €50 000 in Germany (assumed in the absence of an official threshold), €40 000 in Italy, and £30 000 in England. Probabilistic sensitivity analysis indicated that the antibacterial envelope was likely to be cost-effective in patients with other risk factors (including replacement of high power CIEDs, generator replacement with lead modification, and PADIT scores indicating intermediate risk of infection) when used with some device types and in some countries. Conclusions The absorbable antibacterial envelope was associated with cost-effectiveness ratios below European benchmarks in selected patients at increased risk of infection, suggesting the envelope provides value for European healthcare systems by reducing CIED infections.
- Published
- 2021
31. Infections associated with cardiac electronic implantable devices: economic perspectives and impact of the TYRX™ antibacterial envelope
- Author
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Giuseppe Boriani, Marco Vitolo, David Justin Wright, Mauro Biffi, Benedict Brown, Khaldoun G Tarakji, and Bruce L Wilkoff
- Subjects
Prosthesis-Related Infections ,Cost ,Economics ,Cost-Benefit Analysis ,030204 cardiovascular system & hematology ,Infections ,Anti-Bacterial Agents ,Defibrillators, Implantable ,Hospitalization ,03 medical and health sciences ,0302 clinical medicine ,Antibiotics ,Cardiac implantable electronic devices ,Cost-effectiveness ,Physiology (medical) ,Supplement Papers ,Humans ,AcademicSubjects/MED00200 ,030212 general & internal medicine ,Electronics ,Cardiology and Cardiovascular Medicine - Abstract
The occurrence of cardiac implantable electronic devices (CIED) infections and related adverse outcomes have an important financial impact on the healthcare system, with hospitalization length of stay (2–3 weeks on average) being the largest cost driver, including the cost of device system extraction and device replacement accounting for more than half of total costs. In the recent literature, the economic profile of the TYRX™ absorbable antibacterial envelope was analysed taking into account both randomized and non-randomized trial data. Economic analysis found that the envelope is associated with cost-effectiveness ratios below USA and European benchmarks in selected patients at increased risk of infection. Therefore, the TYRX™ envelope, by effectively reducing CIED infections, provides value according to the criteria of affordability currently adopted by USA and European healthcare systems.
- Published
- 2021
32. Antibiotic eluting envelopes: evidence, technology, and defining high-risk populations
- Author
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Khaldoun G. Tarakji, Bruce L. Wilkoff, and Thomas Callahan
- Subjects
Pacemaker, Artificial ,Technology ,medicine.medical_specialty ,Prosthesis-Related Infections ,Cost effectiveness ,medicine.drug_class ,Antibiotics ,Cardiovascular care ,Implantable defibrillator ,law.invention ,law ,Cardiac resynchronization ,Physiology (medical) ,Humans ,Medicine ,AcademicSubjects/MED00200 ,Intensive care medicine ,High risk populations ,Cardiovascular implantable electronic devices ,business.industry ,Mortality rate ,Risk of infection ,Reproducibility of Results ,Antibiotic Prophylaxis ,Anti-Bacterial Agents ,Defibrillators, Implantable ,Pacemaker ,Supplement Papers ,Antibiotic envelope ,Artificial cardiac pacemaker ,Infection ,Cardiology and Cardiovascular Medicine ,business - Abstract
Cardiovascular implantable electronic devices (CIED) are effective and important components of modern cardiovascular care. Despite the dramatic improvements in the functionality and reliability of these devices, over time patients are at risk for developing several morbidities, the most feared of which are local and systemic infections. Despite significant financial investment and aggressive therapy with hospitalization, intravenous antibiotics, and transvenous lead extraction, the outcomes include a 1-year mortality rate as high as 25%. This risk of infection has increased over time, likely due to the increased complexity of the surgical interventions required to insert and replace these devices. The only way to reduce this morbidity and mortality is to prevent these infections, and other than preoperative antibiotics, there were little data supporting effective therapy until the WRAP-IT trial provided randomized data showing that pocket infections can be reduced by 60% at 12 months and major CIED infections reduced by 40% at 1 year with the use of the absorbable antibiotic eluting envelope in patient CIED procedures at high risk of infection. Not all CIED procedures are at high risk of infection and justify the use of the envelope, but cost-effectiveness data support the use of the antibiotic envelope particularly in patients with defibrillator replacements, revisions, and upgrades, such as to a resynchronization device and in patients with prior CIED infection, history of immunocompromise, two or more prior procedures, or a history of renal dysfunction.
- Published
- 2021
33. Transvenous lead extraction in conduction system pacing
- Author
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Nadeev, Wijesuriya, Mark K, Elliott, Vishal, Mehta, Jonathan M, Behar, Steven, Niederer, Bruce L, Wilkoff, and Christopher A, Rinaldi
- Subjects
Physiology ,Physiology (medical) - Abstract
Conduction System Pacing (CSP) delivered by His Bundle Pacing (HBP) or Left Bundle Pacing (LBP) are exciting novel interventions in the field of Cardiac Resynchronization Therapy (CRT). As the evidence base for CSP grows, the volume of implants worldwide is projected to rise significantly in the coming years. As such, physicians will be confronted with increasingly prevalent and vital issues arising in long-term follow up, including the management of infected, malfunctioning, or redundant CSP leads. Transvenous lead extraction (TLE) is the first-line option for removal of pacing leads when indicated in these circumstances. The evidence base for TLE in the context of CSP is still in its infancy. In this article, we first provide a brief overview of TLE. We then examine the data on the long-term performance of HBP leads. Next, we describe the features of the Medtronic Select Secure 3,830 lead, and how experience of TLE of this lead in the paediatric population has informed our practice. Finally, we review the current evidence for TLE in HBP and LBP, and discuss how future studies can address gaps in our current knowledge.
- Published
- 2022
34. Long-term outcomes in nonprogressors to cardiac resynchronization therapy
- Author
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John Rickard, Michael R. Gold, Divyang Patel, Bruce L. Wilkoff, Niraj Varma, Sunil Sinha, Chonyang Albert, J. Emanuel Finet, W.H. Wilson Tang, Joe Marine, and David Spragg
- Subjects
Physiology (medical) ,Cardiology and Cardiovascular Medicine - Abstract
Among patients with heart failure undergoing cardiac resynchronization therapy (CRT), patients with a minimal change in left ventricular ejection fraction (LVEF) have recently been defined as "nonprogressors" rather than as "nonresponders." Little is known regarding long-term outcomes of nonprogressors.We sought to evaluate outcomes in patients undergoing CRT on the basis of echocardiographically determined response status.We reviewed the medical charts of patients with an LVEF of ≤35% and a QRS duration of ≥120 ms undergoing CRT at the Cleveland Clinic, Johns Hopkins Hospital, and Johns Hopkins Bayview Medical Center between 2003 and 2014. Response to CRT was defined on the basis of LVEF change as follows: super-responders ≥20%, responders 6%-19%, nonprogressors 0%-5%, and progressors0%. Survival free of left ventricular assist device (LVAD) and heart transplant was compared on the basis of response classification.A total of 1058 patients were included and had a mean follow-up 8.7 ± 5.4 years, over which time there were 606 end points (37 LVAD implants, 32 heart transplants, and 537 deaths). Survival free of LVAD and heart transplant differed significantly between response groups after CRT both in the mid-term (4 years) and in the long-term (8.7 ± 5.4 years), with super-responders achieving the best outcomes and progressors the worst (P.001). In multivariate analysis, nonprogressors had superior outcomes to progressors (P = .02) at 4 years of follow-up. Over the duration of follow-up (8.7 ± 5.4 years), there was no significant difference in survival between those 2 groups (P = .18).Nonprogressors to CRT have superior medium-term outcomes but similar long-term outcomes to progressors and inferior outcomes to responders and super-responders.
- Published
- 2022
35. Heart rate score, a measure related to chronotropic incompetence in pacemaker patients
- Author
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Brian Olshansky, Bruce L. Wilkoff, Nicholas Wold, David L. Perschbacher, Mark Richards, Paul W. Jones, and Arjun D. Sharma
- Subjects
medicine.medical_specialty ,Chronotropic incompetence ,medicine.medical_treatment ,Cardiac resynchronization therapy ,Sick sinus syndrome ,Clinical ,Internal medicine ,Heart rate score ,Devices ,Medicine ,Diseases of the circulatory (Cardiovascular) system ,Treadmill ,Treadmill testing ,Heart Rate Score ,Risk assessment ,business.industry ,equipment and supplies ,medicine.disease ,Pacemaker ,Clinical diagnosis ,RC666-701 ,Cardiology ,business ,Life study - Abstract
Background: Heart rate score (HrSc) ≥70% in cardiac resynchronization therapy defibrillator and implantable cardioverter-defibrillator subjects predicts 5-year mortality risk. A high HrSc suggests few sensed cardiac cycles above the programmed lower rate. Objective: To determine if HrSc is related to chronotropic incompetence (CI) in pacemaker (PM) subjects. Methods: HrSc is the percentage of all atrial-paced and sensed events in the single tallest 10 beats/min histogram bin programmed to DDD 60/min. The prospective LIFE study of PM subjects examined multiple treadmill-based measures of CI. The 1-month postimplant DDD 60/min PM rate histogram prior to treadmill was retrospectively analyzed for HrSc. Measures of CI were applied to submaximal treadmill data in the DDD mode. HrSc was compared to these CI measures and to clinical indications for PM. Results: The 1-month histogram demonstrated HrSc ≥70% in 43% of subjects. HrSc ≥70% correlated with a clinical diagnosis of sick sinus syndrome (P < .001). CI was present in 34%–88% of subjects by treadmill-based measures. Agreement between treadmill-based measures for CI was poor and varied from 39% to 83%. HrSc ≥70%, as a measure of CI, was most highly correlated with unpaced heart rate
- Published
- 2021
36. CI-452769-4 CONTEMPORARY IMPLANTABLE CARDIOVERTER-DEFIBRILLATOR BENEFIT: A REAL-WORLD ANALYSIS
- Author
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Anne B. Curtis, Angelo Auricchio, Suneet Mittal, Robert A. Pickett, Luke Jacobsen, Jeff Lande, and Bruce L. Wilkoff
- Subjects
Physiology (medical) ,Cardiology and Cardiovascular Medicine - Published
- 2023
37. PO-03-074 INITIAL HEART RATE SCORE IS PREDICTOR FOR OCCURRENCE OF NEW ATRIAL FIBRILLATION INDEPENDENT OF WELL-KNOWN RISK FACTORS AND RELATES TO RIGHT ATRIAL PACING RATE IN PACEMAKER PATIENTS
- Author
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Katsuhide Hayashi, Haruhiko Abe, Ritsuko Kohno, Brian Olshansky, Arjun D. Sharma, Mark Richards, Paul W. Jones, Nicholas Wold, David Perschbacher, and Bruce L. Wilkoff
- Subjects
Physiology (medical) ,Cardiology and Cardiovascular Medicine - Published
- 2023
38. CI-452765-2 CLINICAL PREDICTORS OF INCOMPLETE CS LEAD REMOVAL DURING TRANSVENOUS LEAD EXTRACTION IN THE PATIENTS WITH CARDIAC RESYNCHRONIZATION THERAPY
- Author
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Katsuhide Hayashi, Arwa Younis, Thomas D. Callahan, Bryan Baranowski, David O. Martin, Shady Nakhla, and Bruce L. Wilkoff
- Subjects
Physiology (medical) ,Cardiology and Cardiovascular Medicine - Published
- 2023
39. PO-02-087 NOVEL DEVICE-BASED DISCRIMINATORS IMPROVE DIFFERENTIATION OF POLYMORPHIC VT AND VF FROM MONOMORPHIC VT IN IMPLANTABLE CARDIAC DEFIBRILLATORS
- Author
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Arsalan Derakhshan, Hagai Yavin, Samuel Omotoye, Thomas J. Dresing, Fady Dawoud, Luke C. McSpadden, Jennifer Lecocq Rhude, Kevin J. Davis, Bruce L. Wilkoff, and Christine Tanaka-Esposito
- Subjects
Physiology (medical) ,Cardiology and Cardiovascular Medicine - Published
- 2023
40. MP-453086-11 EXTRACTION OUTCOMES OF IMPLANTABLE CARDIOVERTER-DEFIBRILLATOR LEADS VARY BY MANUFACTURER AND MODEL FAMILY
- Author
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Katsuhide Hayashi, Arwa Younis, Thomas D. Callahan, Bryan Baranowski, David O. Martin, Shady Nakhla, and Bruce L. Wilkoff
- Subjects
Physiology (medical) ,Cardiology and Cardiovascular Medicine - Published
- 2023
41. PO-02-060 RAIL STRENGTH OF LUMENLESS LEADS WITH FEMORAL SNARE DURING EXTRACTION
- Author
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Pierce J. Vatterott, Mark T. Marshall, Blandine A. Mondesert, Thomas Lulic, Taylor A. Noble, and Bruce L. Wilkoff
- Subjects
Physiology (medical) ,Cardiology and Cardiovascular Medicine - Published
- 2023
42. HEALTHCARE UTILIZATION AND HEALTHCARE EXPENDITURES IN PATIENTS WITH INFECTIONS OF PACEMAKERS AND IMPLANTABLE CARDIOVERTER DEFIBRILLATORS
- Author
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Sean Pokorney, Melissa A. Greiner, Eric Black-Maier, Donald D. Hegland, Robert Lewis, Christopher B. Granger, Laurence Mark Epstein, Roger G. Carrillo, Bruce L. Wilkoff, and Jonathan P. Piccini
- Subjects
Cardiology and Cardiovascular Medicine - Published
- 2023
43. Clinical Presentation, Timing, and Microbiology of CIED Infections
- Author
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G. Ralph Corey, Arnold J. Greenspon, Daniel R. Lexcen, Jeffrey D. Lande, Jeanne E. Poole, Charles Kennergren, Bruce L. Wilkoff, Khaldoun G. Tarakji, Alan Cheng, M. Rizwan Sohail, and Suneet Mittal
- Subjects
03 medical and health sciences ,0302 clinical medicine ,medicine.drug_class ,business.industry ,Antibiotics ,medicine ,030212 general & internal medicine ,030204 cardiovascular system & hematology ,Presentation (obstetrics) ,business ,Microbiology - Abstract
Objectives This study characterized the microbiology of major cardiac implantable electronic device (CIED) infections that occurred during the WRAP-IT (Worldwide Randomized Antibiotic Enve...
- Published
- 2021
44. Comparative Analysis of Procedural Outcomes and Complications Between De Novo and Upgraded Cardiac Resynchronization Therapy
- Author
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Oussama M. Wazni, Divyang Patel, Bruce L. Wilkoff, Niraj Varma, Ayman A. Hussein, Mohamed Kanj, Ruth A. Madden, Khaldoun G. Tarakji, Bryan Baranowski, John Rickard, Daniel J. Cantillon, and David M. Nemer
- Subjects
Male ,medicine.medical_specialty ,Ventricular lead ,medicine.medical_treatment ,Venography ,Occlusive disease ,Cardiac resynchronization therapy ,030204 cardiovascular system & hematology ,Cardiac Resynchronization Therapy ,03 medical and health sciences ,0302 clinical medicine ,medicine ,Humans ,Cardiac Resynchronization Therapy Devices ,030212 general & internal medicine ,Single institution ,Heart Failure ,medicine.diagnostic_test ,business.industry ,Incidence (epidemiology) ,medicine.disease ,Surgery ,Stenosis ,Treatment Outcome ,Female ,business - Abstract
This study compared rates of procedural success and complications between de novo cardiac resynchronization therapy (CRT) implantation versus upgrade, including characterization of technical challenges.CRT upgrade is common, but data are limited on the incidence of procedural success and complications as compared to de novo implantation.All patients who underwent a transvenous CRT procedure at a single institution between 2013 and 2018 were reviewed for procedure outcome, 90-day complications, reasons for unsuccessful left ventricular lead delivery, and the presence of venous occlusive disease (VOD) that required a modified implantation technique.Among 1,496 patients, 947 (63%) underwent de novo implantation and 549 (37%) underwent device upgrade. Patients who received a device upgrade were older (70 ± 12 years vs. 68 ± 13 years; p 0.01), with a male predominance (75% vs. 66%; p 0.01) and greater prevalence of comorbidities. There was no difference in the rate of procedural success between de novo and upgrade CRT procedures (97% vs. 96%; p = 0.28) or 90-day complications (5.1% vs. 4.6%; p = 0.70). VOD was present in 23% of patients who received a device upgrade and was more common among patients with a dual-chamber versus a single-chamber device (26% vs. 9%; p 0.001). Patients with and without VOD had a similar composite outcome of procedural failure or complication (8.0% vs. 7.8%; p = 1.0).Rates of procedural success and complications were no different between de novo CRT implantations and upgrades. VOD frequently increased procedural complexity in upgrades, but alternative management strategies resulted in similar outcomes. Routine venography before CRT upgrade may aid in procedural planning and execution of these strategies.
- Published
- 2021
45. Transvenous lead extraction in patients with prior extraction procedures: Procedural profiles and outcomes
- Author
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David O. Martin, Khaldoun G. Tarakji, Oussama M. Wazni, Ayman A. Hussein, Mina K. Chung, Mohamed Diab, Daniel J. Cantillon, Simrat Kaur, Bruce L. Wilkoff, Erika Hutt, Mohamed Kanj, Mark Niebauer, Thomas Callahan, John Rickard, Niraj Varma, Walid Saliba, and Thomas Dresing
- Subjects
Male ,Catheterization, Central Venous ,Pacemaker, Artificial ,medicine.medical_specialty ,Vein injury ,030204 cardiovascular system & hematology ,behavioral disciplines and activities ,03 medical and health sciences ,0302 clinical medicine ,Physiology (medical) ,medicine ,Humans ,Fluoroscopy ,In patient ,Prospective Studies ,030212 general & internal medicine ,Lead (electronics) ,Device Removal ,Subclinical infection ,medicine.diagnostic_test ,business.industry ,Middle Aged ,Defibrillators, Implantable ,nervous system diseases ,Transvenous lead ,Surgery ,Treatment Outcome ,nervous system ,Equipment Failure ,Female ,Patient Safety ,Cardiology and Cardiovascular Medicine ,Complication ,business ,Follow-Up Studies - Abstract
Subclinical venous injuries are common during transvenous lead extraction (TLE), but their implications for future TLE are unclear. Little is known about whether a prior TLE adds risk or complexity to subsequent extraction procedures.The purpose of this study was to assess procedural profiles and outcomes of TLE based on whether patients had prior extraction procedures.All 3258 consecutive patients undergoing TLE at the Cleveland Clinic (1996-2012) were included. Procedural profiles and outcomes were determined.Of 3258 TLEs, 198 had prior TLE. Median number of leads in place was 2 in both groups, but patients with prior TLE were more likely to have defibrillator leads (47% vs 41%; P = .08) and more likely to be pacemaker-dependent (32% vs 25%; P = .02). The age of oldest lead (median 2134 vs 1902 days; P = .4) and combined age of leads (median 2948 vs 2676 days; P = .6) were comparable. Procedures were longer in those with prior TLE (166 ± 79 minutes vs 149 ± 74 minutes; P = .004) with comparable fluoroscopy times (median 13 vs 11 minutes; P = .07), and successful extraction was more likely to require specialized tools (88% vs 81%; P = .006) with higher likelihood of rescue femoral workstation (12% vs 4%; P.0001). Clinical success rates were comparable in those with prior TLE (99.5% vs 98.9%; P = .8) with similar major (3.0% vs 1.9%; P = .3) and minor (3.0% vs 3.7%; P = .8) complication rates.Extraction procedures were more challenging in patients with prior TLE compared to those without prior TLE but with excellent success and low complication rates.
- Published
- 2020
46. Use of virtual visits for the care of the arrhythmia patient
- Author
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Khaldoun G. Tarakji, Peter A. Rasmussen, Bryan Baranowski, Bruce L. Wilkoff, Daniel J. Cantillon, Mohamed Kanj, Henry Hilow, Thomas Callahan, Walid Saliba, Divyang Patel, Mandeep Bhargava, Oussama M. Wazni, Thomas Dresing, Megan Eppich, Patrick J. Tchou, Ayman A. Hussein, and Peter T Hu
- Subjects
Male ,medicine.medical_specialty ,Telemedicine ,Office visits ,Telehealth ,030204 cardiovascular system & hematology ,03 medical and health sciences ,0302 clinical medicine ,Physiology (medical) ,Outpatients ,Health care ,medicine ,Humans ,Prospective Studies ,030212 general & internal medicine ,Prospective survey ,Aged ,business.industry ,Arrhythmias, Cardiac ,Digital health ,Patient Satisfaction ,Monitoring data ,Physical therapy ,Female ,Level of care ,Cardiology and Cardiovascular Medicine ,business ,Follow-Up Studies - Abstract
Background Virtual visits (VVs) are a modality for delivering health care services remotely through videoconferencing tools. Data about patient and physician experience in using VVs are limited. Objective The purpose of this study was to assess patient and physician experience with the use of VVs in cardiac electrophysiology. Methods We performed a prospective survey of cardiac electrophysiology patients and physicians who participated in an outpatient VV from December 2018 to July 2019. Results One-hundred consecutive VVs were included. Sixty-four patients elected to complete a survey. Patients rated their experience as either excellent/very good in scheduling a VV (87%), seeing their physician of choice (100%), transmitting arrhythmia data (88%), rating their physician's ability to communicate (98%), asking all questions (98%), rating the level of care received (98%), paying for the cost of a VV (67%), and rating their overall level of satisfaction (98%). Thirty-eight of 64 patients (59.4%) preferred a VV for their next visit, 12 of 64 (18.8%) preferred an in-office visit, 13 of 64 (20.3%) responded that their decision for a virtual or office visit depended on indication, and 1 of 64 (1.6%) had no preference. A total of 14 cardiac electrophysiologists participated in 100 VVs. Nine visits were not included due to technical difficulty. Physician responses to survey questions were rated as excellent/very good in the ability to communicate (92%), accessing monitoring data (95%), and overall level of satisfaction (98%). Conclusion In our small study population, most patients and physicians prefer VVs. Convenience, cost, and reason for follow-up were important determinants that affected both patient and physician preference.
- Published
- 2020
47. Cardiac venous injuries: Procedural profiles and outcomes during left ventricular lead placement for cardiac resynchronization therapy
- Author
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Johnny Chahine, Mohamed Kanj, Mark Niebauer, Bryan Baranowski, Ayman A. Hussein, Niraj Varma, Walid Saliba, Khaldoun G. Tarakji, Daniel J. Cantillon, John Rickard, Mandeep Bhargava, Mina K. Chung, Mohamed M. Gad, Bruce L. Wilkoff, Mohamed Diab, Oussama M. Wazni, Thomas Callahan, Patrick J. Tchou, and Thomas Dresing
- Subjects
Male ,medicine.medical_specialty ,Ventricular lead ,medicine.medical_treatment ,Perforation (oil well) ,Cardiac resynchronization therapy ,030204 cardiovascular system & hematology ,Coronary Angiography ,Electrocardiography ,03 medical and health sciences ,0302 clinical medicine ,Physiology (medical) ,Cardiac tamponade ,medicine ,Humans ,In patient ,Cardiac Resynchronization Therapy Devices ,030212 general & internal medicine ,Coronary sinus ,Aged ,Retrospective Studies ,Heart Failure ,business.industry ,Prognosis ,medicine.disease ,Coronary Vessels ,Electrodes, Implanted ,Surgery ,Dissection ,Heart Injuries ,Female ,Cardiology and Cardiovascular Medicine ,Lead Placement ,business ,Follow-Up Studies - Abstract
Background Injury to the cardiac venous structures can complicate left ventricular lead placement for cardiac resynchronization therapy (CRT). Little is known about the outcomes of coronary sinus (CS) dissection with or without perforation. Objective The purpose of this study was to determine the outcomes in patients who had a CS injury during CRT implantation. Methods All patients undergoing procedures for CRT implantation at the Cleveland Clinic (2001–2018) were enrolled in a prospectively maintained registry for procedural profiles and complications. All patients with cardiac venous injuries during the procedures were included. Results CS injury occurred in 35 of 5011 patients (0.7%; 6 perforations (17.1%), 29 dissections without perforation (82.9%)). In patients with dissection in the absence of perforation, attempts at CS lead placement after dissection were successful in 21 of 29 patients (72.4%). In those with perforation (n=6, 17.1%), CS lead placement was successful in one of them (16.7%). Cardiac tamponade occurred in 2 patients (5.7%), and the procedure was aborted in both of them. Overall, CS lead placement failed in 13 patients (37%) but 9 (25.7%) underwent subsequent CRT with CS lead placement (n=6, 17.1%; median 58 days later) or epicardial leads (n=3, 8.6%). Three of the remaining 4 patients (8.6%) refused to undergo further procedures, and the fourth (2.9%) died of a complicated course. Conclusion CS injury is not common during CRT implantation procedures and did not preclude successful lead placement in 23 of 35 patients (65.7%) during the index procedure and 6 of 6 (100%) during the subsequent attempted procedures. A low rate of mortality was observed in such patients, but CS injury was associated with increased morbidity.
- Published
- 2020
48. Innovative Approaches and Technology Platforms for Pacemaker Lead Extraction
- Author
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Thomas D. Callahan and Bruce L. Wilkoff
- Published
- 2022
49. List of contributors
- Author
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Jonathan Afoke, Mahboob Ali, Cristiano Amarelli, Yoshimori An, Balaram Anandamurthy, Amedeo Anselmi, Kedar K. Aras, Imran Arif, Vincent Auffret, Michael Austriaco, Robert H. Bartlett, Michael I. Brener, Daniel J.P. Burns, Thomas D. Callahan, Adam W. Cates, Laura Cercenelli, Jacob Chacko, Raphaelle A. Chemtob, Yeon Sik Choi, Ivan Corazza, Anna Corsini, James L. Cox, Ruggero De Paulis, Erwan Donal, Colin K. Drummond, Seraina Anne Dual, David D’Alessandro, Igor R. Efimov, Michael Emery S., Jaime-Jürgen Eulert-Grehn, Frank M. Fago, Giulio Folino, Kiyotaka Fukamachi, Isaac George, Marc Gillinov, Patrick M. Grady, Jordan Groskurth, Philip Hartley, Kevin E. Hodges, David J. Horvath, Jeffrey J. Hsu, Ayman A. Hussein, Atsushi Ikeda, Jamshid H. Karimov, Helen S. Knight, Christopher K. Koehler, Nakul Kumar, Shunsuke Kuroda, Knut Kvernebo, Panagiotis G. Kyriazis, Guillaume Leurent, Guiqing Liu, Mark S. Lobosky, Amanda L. Mahoney, Emanuela Marcelli, Joseph Mauch, Patrick M. McCarthy, Alana N. Miniovich, Chihiro Miyagi, Takuma Miyamoto, Matthew V. Monti, Ryan A. Moore, David L.S. Morales, Hani Najm, Hiroshi Nakagawa, Vinci Naruka, Johan Nilsson, Carrie L. Ochocki, Lucrezia Palmieri, Dermot M.J. Phelan, Alistair Phillips, Anthony R. Polakowski, Evgenij Potapov, Shane S. Pullins, Prakash P. Punjabi, Suzanne Ratzloff, Rahul D. Renapurkar, Ellen T. Roche, Luca Rosalia, Mossab Saeed Y., Shiva Sale, Andrea Salica, Raffaele Scaffa, Marianne Schmid Daners, Dhruv Seshadri R., Christoph Starck, Randall C. Starling, Nicholas A. Szugye, W. H. Wilson Tang, Varun Thachil, Tomasz Timek, Niraj Varma, Jean-Philippe Verhoye, Brett J. Wakefield, Oussama M. Wazni, Luca Weltert, Bruce L. Wilkoff, Rose T. Yin, Katsuaki Yokoyama, James B. Young, Margherita Zecchi, and Andreas Zuckermann
- Published
- 2022
50. Abstract 10735: Conduction Abnormalities and Pacemaker Implantation in Patients with Radiation-Associated Cardiac Disease
- Author
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Samantha Xu, Wynne Zheng, Susan Ospina, Eoin Donnellan, Brian P Griffin, Douglas Johnston, Samir R Kapadia, Bruce L Wilkoff, and Milind Y Desai
- Subjects
Physiology (medical) ,Cardiology and Cardiovascular Medicine - Abstract
Introduction: We sought to study prevalence of conduction disease and permanent pacemaker (PPM) in patients presenting with radiation-associated cardiac disease (RACD) and its impact on long-term survival. Methods: We studied 699 patients with documented RACD (prior chest radiotherapy at a mean of 22 years prior) evaluated at a single center from 1998-2018. Conduction abnormalities and PPM at baseline were recorded, along with cardiac procedures performed during follow-up. Death was the primary endpoint. Results: Patients were divided into 4 groups: 1) no procedure during follow-up 2) 1 valve or coronary artery bypass grafting (CABG) or 1-valve+CABG surgery 3) Multivalve+/-CABG+/-aortic/pericardial surgery and 4)Trans catheter aortic valve replacement (TAVR). Relevant characteristics and outcomes are shown in Table. In total, 183 patients had a PPM (82 [45%] implanted during follow-up). Over a mean follow-up of 5±4 years (range 0-21 years), 370 patients (53%) patients died. On survival analysis, presence of PPM (HR 1.26 [1.03-1.54], p=0.03) was independently associated with higher long-term mortality; 109 (60%) patients with PPM died in the long-term vs. those without261 (51%, log-rank p-value=0.03). Conclusion: RACD patients have a high rate of mortality during longer-term follow-up, despite a low calculated preoperative risk. In addition, they have a high rate of conduction abnormalities with a high proportion requiring PPM, including at baseline, irrespective of need for a cardiac procedure. Presence of a PPM was independently associated with long-term risk of mortality.
- Published
- 2021
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