188 results on '"Exner DV"'
Search Results
2. OUTCOME OF LEFT VENTRICULAR DYSFUNCTION AFFECTED BY RACE
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Dries, DL, primary, Exner, DV, additional, and Gersh, BJ, additional
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- 1999
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3. Occurrence of phrenic nerve stimulation in cardiac resynchronization therapy patients: the role of left ventricular lead type and placement site.
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Biffi M, Exner DV, Crossley GH, Ramza B, Coutu B, Tomassoni G, Kranig W, Li S, Kristiansen N, and Voss F
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- 2013
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4. 2012 EHRA/HRS expert consensus statement on cardiac resynchronization therapy in heart failure: implant and follow-up recommendations and management.
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Daubert JC, Saxon L, Adamson PB, Auricchio A, Berger RD, Beshai JF, Breithard O, Brignole M, Cleland J, Delurgio DB, Dickstein K, Exner DV, Gold M, Grimm RA, Hayes DL, Israel C, Leclercq C, Linde C, Lindenfeld J, and Merkely B
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- 2012
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5. 2012 EHRA/HRS expert consensus statement on cardiac resynchronization therapy in heart failure: implant and follow-up recommendations and management: A registered branch of the European Society of Cardiology (ESC), and the Heart Rhythm Society; and in collaboration with the Heart Failure Society of America (HFSA), the American Society of Echocardiography (ASE), the American Heart Association (AHA), the European Association of Echocardiography (EAE) of the ESC and the Heart Failure Association of the ESC (HFA). * Endorsed by the governing bodies of AHA, ASE, EAE, HFSA, HFA, EHRA, and HRS.
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Daubert JC, Saxon L, Adamson PB, Auricchio A, Berger RD, Beshai JF, Breithard O, Brignole M, Cleland J, Delurgio DB, Dickstein K, Exner DV, Gold M, Grimm RA, Hayes DL, Israel C, Leclercq C, Linde C, Lindenfeld J, and Merkely B
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- 2012
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6. Clinical predictors of fidelis lead failure: report from the canadian heart rhythm society device committee.
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Birnie DH, Parkash R, Exner DV, Essebag V, Healey JS, Verma A, Coutu B, Kus T, Mangat I, Ayala-Paredes F, Nery P, Wells G, and Krahn AD
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- 2012
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7. Baseline delayed left ventricular activation predicts long-term clinical outcome in cardiac resynchronization therapy recipients.
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Eitel C, Wilton SB, Switzer N, Cowan K, and Exner DV
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- 2012
8. Systematic assessment of patients with unexplained cardiac arrest: Cardiac Arrest Survivors With Preserved Ejection Fraction Registry (CASPER).
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Krahn AD, Healey JS, Chauhan V, Birnie DH, Simpson CS, Champagne J, Gardner M, Sanatani S, Exner DV, Klein GJ, Yee R, Skanes AC, Gula LJ, Gollob MH, Krahn, Andrew D, Healey, Jeffrey S, Chauhan, Vijay, Birnie, David H, Simpson, Christopher S, and Champagne, Jean
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- 2009
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9. Implantable cardioverter defibrillator therapy for patients with less severe left ventricular dysfunction.
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Exner DV
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- 2009
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10. Noninvasive risk assessment early after a myocardial infarction the REFINE study.
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Exner DV, Kavanagh KM, Slawnych MP, Mitchell LB, Ramadan D, Aggarwal SG, Noullett C, Van Schaik A, Mitchell RT, Shibata MA, Gulamhussein S, McMeekin J, Tymchak W, Schnell G, Gillis AM, Sheldon RS, Fick GH, Duff HJ, and REFINE Investigators
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- 2007
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11. Partner quality of life in the Antiarrhythmics Versus Implantable Defibrillators trial.
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Jenkins LS, Powell JL, Schron EB, McBurnie MA, Bosworth-Farrell S, Moore R, Exner DV, and AVID Investigators
- Abstract
BACKGROUND AND OBJECTIVE: The quality of life (QOL) of patients with ventricular dysrhythmias is well studied, but less is known about the QOL of their partners. This study describes the QOL of partners of patients with serious ventricular dysrhythmias enrolled in the Antiarrhythmics Versus Implantable Defibrillators trial. SUBJECTS AND METHODS: A convenience sample of 124 partners of patients randomized to antiarrhythmic drugs (n = 59) or an implantable cardioverter defibrillator (n = 65) in the Antiarrhythmics versus Implantable Defibrillators trial was obtained. The Short Form-36 and Quality of Life Index were assessed at baseline (postrandomization) and at 3-, 6-, and 12-month follow-up. RESULTS AND CONCLUSIONS: The mean age of the partners was 62 years. Most were white and female. Their mean Short Form-36 scores were comparable to a normative age group. Partner and participant mean Short Form-36 and Quality of Life Index scores correlated modestly (range 0.25-0.36). The physical summary scores of partners using the Short Form-36 declined over time, whereas their mental summary scores remained stable. Partner concerns related to death, dysrhythmia recurrence, and the impact of dysrhythmias on enjoyment of life lessened from baseline to 12 months. Concern about implantable cardioverter defibrillator function remained stable over time. Although the sample size of this study was relatively small and limited by missing data for some assessments, it is the largest prospective study of QOL in partners of patients with serious dysrhythmias. The results offer a foundation for future research of the partners of patients with serious dysrhythmias in terms of identifying their needs, offering support, and maximizing QOL. [ABSTRACT FROM AUTHOR]
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- 2007
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12. Paced QT dispersion and QT morphology after radiofrequency atrioventricular junction ablation: impact of left ventricular function.
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Raj SR, Gillis AM, Mitchell B, Wyse DG, Sheldon RS, Exner DV, Morck M, and Duff HJ
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Catheter ablation of the atrioventricular junction (AVJ) is a widely accepted treatment for drug refractory atrial fibrillation. Unfortunately, there have been some reports of pause dependent ventricular arrhythmias associated with QT interval prolongation, mainly in patients with reduced LV function. The present investigation evaluates the association of LV function with QT dispersion in response to a sudden rate drop. ECGs were' recorded on 20 patients (13 with normal LV function) on the day following AVJ ablation while paced at a range of ventricular rates (40-120 beats/min), and during a sudden drop from 80 to 40 beats/min. The maximum QT interval (QTmax), minimum QT interval (QTmin), and QT interval dispersion (QTdisp) were compared. In both groups, the QTmax and QTmin increased at slower paced heart rates while the QTdisp did not change. In response to a sudden rate drop from 80 to 40 beats/min, the QTmax increased in both groups of LV function (trend), while the QTmin increased in those with normal LV function (24 +/- 22 ms), but not in those with reduced LV function (0 +/- 14 ms; P = 0.01). Consequently, the QTdisp increased significantly in those with reduced LV function (31 +/- 23 ms) but not in normal LV function (-5 +/- 29 ms; P = 0.01). Morphological QTU changes developed following the sudden rate drop in 67% of the reduced LV versus 8% of the normal LV (P = 0.02) function groups. Following AVJ ablation, QTdisp increased during a sudden rate drop in patients with reduced LV function, but not in patients with normal LV function. [ABSTRACT FROM AUTHOR]
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- 2003
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13. Quality of life in the antiarrhythmics versus implantable defibrillators trial: impact of therapy and influence of adverse symptoms and defibrillator shocks.
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Schron EB, Exner DV, Yao Q, Jenkins LS, Steinberg JS, Cook JR, Kutalek SP, Friedman PL, Bubien RS, Page RL, Powell J, AVID Investigators, Schron, Eleanor B, Exner, Derek V, Yao, Qing, Jenkins, Louise S, Steinberg, Jonathan S, Cook, James R, Kutalek, Steven P, and Friedman, Peter L
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- 2002
14. Lesser response to angiotensin-converting-enzyme inhibitor therapy in black as compared with white patients with left ventricular dysfunction.
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Exner DV, Dries DL, Domanski MJ, and Cohn JN
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- 2001
15. Racial differences in the outcome of left ventricular dysfunction.
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Dries DL, Exner DV, Gersh BJ, Cooper HA, Carson PE, and Domanski MJ
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- 1999
16. Is it time to expand the use of cardiac resynchronization therapy to patients with mildly symptomatic heart failure?
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Exner DV
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- 2009
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17. Arguments prove nothing unless verified. A commentary on Kaufman's 'Epidemiologic analysis of racial/ethnic disparities: some fundamental issues and a cautionary example'.
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Exner DV and Cohn JN
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- 2008
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18. Prevention of atrial fibrillation following cardiac surgery.
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Arias MA, Potter BJ, LeLorier J, Kwatra MM, Mitchell LB, and Exner DV
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- 2006
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19. Proarrhythmia in patients with the Wolff-Parkinson-White syndrome after standard doses of intravenous adenosine.
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Exner DV, Muzyka T, Gillis AM, Exner, D V, Muzyka, T, and Gillis, A M
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- 1995
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20. Microvolt T-wave alternans physiological basis, methods of measurement, and clinical utility--consensus guideline by International Society for Holter and Noninvasive Electrocardiology.
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Verrier RL, Klingenheben T, Malik M, El-Sherif N, Exner DV, Hohnloser SH, Ikeda T, Martínez JP, Narayan SM, Nieminen T, Rosenbaum DS, Verrier, Richard L, Klingenheben, Thomas, Malik, Marek, El-Sherif, Nabil, Exner, Derek V, Hohnloser, Stefan H, Ikeda, Takanori, Martínez, Juan Pablo, and Narayan, Sanjiv M
- Abstract
This consensus guideline was prepared on behalf of the International Society for Holter and Noninvasive Electrocardiology and is cosponsored by the Japanese Circulation Society, the Computers in Cardiology Working Group on e-Cardiology of the European Society of Cardiology, and the European Cardiac Arrhythmia Society. It discusses the electrocardiographic phenomenon of T-wave alternans (TWA) (i.e., a beat-to-beat alternation in the morphology and amplitude of the ST-segment or T-wave). This statement focuses on its physiological basis and measurement technologies and its clinical utility in stratifying risk for life-threatening ventricular arrhythmias. Signal processing techniques including the frequency-domain Spectral Method and the time-domain Modified Moving Average method have demonstrated the utility of TWA in arrhythmia risk stratification in prospective studies in >12,000 patients. The majority of exercise-based studies using both methods have reported high relative risks for cardiovascular mortality and for sudden cardiac death in patients with preserved as well as depressed left ventricular ejection fraction. Studies with ambulatory electrocardiogram-based TWA analysis with Modified Moving Average method have yielded significant predictive capacity. However, negative studies with the Spectral Method have also appeared, including 2 interventional studies in patients with implantable defibrillators. Meta-analyses have been performed to gain insights into this issue. Frontiers of TWA research include use in arrhythmia risk stratification of individuals with preserved ejection fraction, improvements in predictivity with quantitative analysis, and utility in guiding medical as well as device-based therapy. Overall, although TWA appears to be a useful marker of risk for arrhythmic and cardiovascular death, there is as yet no definitive evidence that it can guide therapy. [ABSTRACT FROM AUTHOR]
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- 2011
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21. Microvolt T-wave alternans testing has a role in arrhythmia risk stratification.
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Verrier RL, Klingenheben T, Malik M, El-Sherif N, Exner DV, Hohnloser SH, Ikeda T, Martínez JP, Narayan SM, Nieminen T, and Rosenbaum DS
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- 2012
22. Atrioventricular Synchrony Delivered by a Dual-Chamber Leadless Pacemaker System.
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Ip JE, Rashtian M, Exner DV, Reddy VY, Doshi R, Badie N, Nevo JR, Goil A, Defaye P, Canby R, Bongiorni MG, Shoda M, Hindricks G, and Knops RE
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- Humans, Male, Female, Aged, Prospective Studies, Aged, 80 and over, Heart Rate, Electrocardiography, Ambulatory, Middle Aged, Cardiac Pacing, Artificial methods, Pacemaker, Artificial
- Abstract
Background: A dual-chamber leadless pacemaker system has been designed for atrioventricular synchronous pacing using wireless, beat-to-beat, implant-to-implant (i2i) communication between distinct atrial and ventricular leadless pacemakers. The atrioventricular synchrony achieved across various ambulatory scenarios has yet to be systematically evaluated., Methods: A prospective, single-arm, unblinded, multicenter, international clinical trial of the leadless pacemaker system was conducted in patients with a conventional dual-chamber pacing indication enrolled from February 2022 to March 2023. Leadless pacemaker systems were implanted, and 12-lead Holter electrocardiographic recordings were collected 3 months after implantation over various postures/activities: sitting, supine, left lateral recumbent, right lateral recumbent, standing, normal walk, and fast walk. An independent Holter core laboratory performed a manual adjudication of the percent of atrioventricular synchronous beats using the standard 300-millisecond PR interval limit. Atrium-to-ventricle and ventricle-to-atrium i2i communication success rates were also assessed. Post hoc summary statistics describing the relationships between atrioventricular synchrony and i2i success, posture/activity, implantation indication, atrioventricular event, and heart rate were calculated., Results: In the evaluable population (n=384 of 464 enrolled [83%]; 61% male; age, 70 years; weight, 82 kg; 60% ejection fraction; 95% of beats evaluable), the mean atrioventricular synchrony of 98% of beats observed across all postures using the standard 300-millisecond limit was greater than both atrial-to-ventricular i2i (94%) and ventricular-to-atrial i2i (94%; P <0.001), exceeding both i2i values in 95% of patients. Atrioventricular synchrony was achieved in >95% of evaluable beats across all postures/activities, implantation indications, atrioventricular paced/sensed event combinations, and heart rate ranges (including >100 bpm)., Conclusions: This dual-chamber leadless pacemaker system demonstrated atrioventricular synchrony in 98% of evaluable beats at 3 months after implantation. Atrioventricular synchrony was maintained across postures/activities and remained robust for heart rates >100 bpm., Competing Interests: Dr Ip reports consulting fees from Abbott and Medtronic and serves as a Steering Committee member for Abbott and a Data Safety Monitoring Committee member for Boston Scientific. Dr Rashtian reports research grants and consulting fees from Abbott. Dr Exner reports consulting fees and research grants from Abbott and Medtronic and, unrelated to this article, reports consulting fees and research grants from Boston Scientific and GE Healthcare, as well equity in CorVista, Clarius, eMurmur, HelpWear, and ProtonIntel. Dr Reddy is a consultant to Abbott. Unrelated to this article, he serves as a consultant for and has equity in Ablacon, Acutus Medical, Affera-Medtronic, Apama Medical-Boston Scientific, Anumana, APN Health, Aquaheart, Atacor, Autonomix, Axon Therapies, Backbeat, BioSig, CardiaCare, CardioNXT/ AFTx, Circa Scientific, CoRISMA, Corvia Medical, Dinova-Hangzhou DiNovA EP Technology, East End Medical, EPD-Philips, EP Frontiers, Epix Therapeutics-Medtronic, EpiEP, Eximo, Farapulse-Boston Scientific, Field Medical, Focused Therapeutics, HRT, Intershunt, Javelin, Kardium, Keystone Heart, Laminar, LuxMed, Medlumics, Middlepeak, Neutrace, Nuvera-Biosense Webster, Oracle Health, Restore Medical, Sirona Medical, SoundCath, and Valcare; unrelated to this work, has served as a consultant for AtriAN, Biosense Webster, BioTel Heart, Biotronik, Boston Scientific, Cairdac, Cardiofocus, Cardionomic, CoreMap, Fire1, Gore & Associates, Impulse Dynamics, Medtronic, Novartis, Philips, Pulse Biosciences; and he has equity in DRS Vascular, Manual Surgical Sciences, Newpace, Nyra Medical, Surecor, and Vizaramed. Dr Doshi reports consulting fees from Abbott and serves as a steering committee member for Abbott. Dr Badie, J.R. Nevo, and A. Goil are employees of Abbott. Dr Defaye reports research grants from Abbott, Boston Scientific, and Medtronic. Dr Canby reports consulting fees from Medtronic. Dr Grazia Bongiorni serves as a steering committee member for Abbott. Dr Shoda serves as a Steering Committee member for Abbott. Dr Hindricks serves as a Steering Committee member for Abbott. Dr Knops reports research grants, consulting fees, and serving as a Steering Committee member for Abbott and Boston Scientific and speaking fees from Medtronic.
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- 2024
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23. Effects of Implantable Cardioverter-Defibrillator Leads on the Tricuspid Valve and Right Ventricle: A Randomized Trial.
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Leong DP, Dokainish H, Mondésert B, Cavalli G, Khetan A, Cirne F, Baro Vila R, Klimis H, De Jesus TA, AlGhasab NS, Akbari V, Suliman A, Eltebi O, Almhri A, Ferdous T, Djuric A, Bashir J, Krahn AD, Exner DV, Philippon F, Birne DH, Joza J, and Healey JS
- Abstract
Background: There are no randomized data to inform the extent to which transvenous cardiac leads cause tricuspid regurgitation (TR)., Objectives: This study sought to determine the effect of a transvenous implantable cardioverter-defibrillator (TV-ICD) on TR severity, and secondarily, on right ventricular (RV) size and function., Methods: We evaluated TR severity before and 6 months after implantable cardioverter-defibrillator insertion in a post hoc analysis of adults randomized to receive a transvenous (n = 252) or subcutaneous implantable cardioverter-defibrillator (S-ICD) (n = 251) device. TR and RV size and systolic function were assessed by echocardiographic images analyzed in a core laboratory., Results: At baseline, at least mild TR was present in 30% of individuals. At 6 months, the proportion of participants with any TR in the TV-ICD group was 42% vs 19% in the S-ICD group (P < 0.001). The proportion with moderate or severe TR was 7% in the TV-ICD group vs 2% in the S-ICD group (P = 0.021). At 6 months, the OR of at least 1 grade worsening of TR in the TV-ICD group as compared with the S-ICD group was 7.2 (95% CI: 3.3-15.8; P < 0.001). There were no differences between groups with respect to RV size or systolic function., Conclusions: Six months following TV-ICD insertion, there was a 7-fold increase in the risk of at least 1 grade worsening of TR, with 7% of individuals having TR that was moderate or severe. There was no detectable difference in RV size or function; however, longer follow-up is needed., Competing Interests: Funding Support and Author Disclosures This study was funded by Boston Scientific through an unrestricted research grant. Boston Scientific did not have any input into the preparation of this manuscript. Dr Leong has received consultancy fees from Boston Scientific. Dr Mondésert has received consultancy and speaking fees from Bostin Scientific, Abbott, Medtronic, and Biotronik. Dr Joza has received research support from Medtronic Inc; consulting fees from Boston Scientific; and honoraria from Biosense Webster Canada. Dr Healey has received research support and speaking fees from BMS/Pfizer, Boston Scientific, and Medtronic; speaking fees from Servier; and consultancy fees from Bayer and Boston Scientific. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2024 The Authors. Published by Elsevier Inc. All rights reserved.)
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- 2024
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24. Six-month electrical performance of the first dual-chamber leadless pacemaker.
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Hindricks G, Doshi R, Defaye P, Exner DV, Reddy VY, Knops RE, Canby R, Shoda M, Bongiorni MG, Neužil P, Callahan T, Sundaram S, Badie N, and Ip JE
- Abstract
Background: The first dual-chamber leadless pacemaker (DC-LP) system consists of 2 separate atrial and ventricular devices that communicate to maintain synchronous atrioventricular pacing and sensing. The initial safety and efficacy were previously reported., Objective: The purpose of this study was to evaluate the chronic electrical performance of the DC-LP system., Methods: Patients meeting standard dual-chamber pacing indications were enrolled and implanted with the DC-LP system (Aveir DR, Abbott), including right atrial and ventricular helix-fixation LPs (atrial leadless pacemaker [ALP], ventricular leadless pacemaker [VLP]). Pacing capture threshold, sensed amplitude, and pacing impedance were collected using the device programmer at prespecified timepoints from 0-6 months postimplant., Results: De novo devices were successfully implanted in 381 patients with complete 6-month data (62% male; age 69 ± 14 years; weight 82 ± 20 kg; 65% sinus nodal dysfunction, 30% atrioventricular block). ALPs were implanted predominantly in the right atrial appendage anterior base and VLPs primarily at the mid-to-apical right ventricular septum. From implant to 1 month, pacing capture thresholds (0.4-ms pulse width) improved in both ALPs (2.4 ± 1.5 V to 0.8 ± 0.8 V; P <.001) and VLPs (0.8 ± 0.6 V to 0.6 ± 0.4 V; P <.001). Sensed amplitudes improved in both ALPs (1.8 ± 1.3 mV to 3.4 ± 1.9 mV; P <.001) and VLPs (8.8 ± 4.0 mV to 11.7 ± 4.2 mV; P <.001). Impedances were stable in ALPs (334 ± 68 Ω to 329 ± 52 Ω; P = .17) and reduced in VLPs (789 ± 351 Ω to 646 ± 190 Ω; P <.001). Electrical measurements remained relatively stable from 1-6 months postimplant. No differences in electrical metrics were observed among ALP or VLP implant locations., Conclusion: This first in-human evaluation of the new dual-chamber leadless pacemaker system demonstrated reliable electrical performance throughout the initial 6-month evaluation period., Competing Interests: Disclosures Dr Rahul Doshi, Dr Derek V. Exner, Dr Vivek Y. Reddy, Dr Reinoud E. Knops, Dr Petr Neužil, Dr Thomas Callahan, Dr Sri Sundaram, and Dr James E. Ip report Abbott consulting fees. Dr Pascal Defaye, Dr Derek V. Exner, and Dr Reinoud E. Knops report Abbott research grants. Dr Derek V. Exner, Dr Thomas Callahan, and Dr Sri Sundaram report Abbott honoraria. Dr Gerhard Hindricks, Dr Rahul Doshi, Dr Reinoud E. Knops, Dr Morio Shoda, Dr Maria Grazia Bongiorni, and Dr James E. Ip serve as Abbott steering committee members. Dr Nima Badie is an Abbott employee. Additional Disclosures unrelated to this manuscript: Dr Petr Neužil reports research grants from Boston Scientific and Medtronic. Dr Derek V. Exner serves as a consultant for Boston Scientific, Medtronic, and GE Healthcare; and has equity in Clarius, CorVista eMurmur, HelpWear, and ProtonIntel. Dr Vivek Y. Reddy serves as a consultant for and has equity in Ablacon, Acutus Medical, Affera-Medtronic, Apama Medical-Boston Scientific, Anumana, APN Health, Aquaheart, Atacor, Autonomix, Axon Therapies, Backbeat, BioSig, CardiaCare, CardioNXT/AFTx, Circa Scientific, CoRISMA, Corvia Medical, Dinova-Hangzhou DiNovA EP Technology, East End Medical, EPD-Philips, EP Frontiers, Epix Therapeutics-Medtronic, EpiEP, Eximo, Farapulse-Boston Scientific, Field Medical, Focused Therapeutics, HRT, Intershunt, Javelin, Kardium, Keystone Heart, Laminar Medical, LuxMed, Medlumics, Middlepeak, Neutrace, Nuvera-Biosense Webster, Oracle Health, Restore Medical, Sirona Medical, SoundCath, Valcare. Dr Vivek Y. Reddy has served as a consultant for Adagio Medical, AtriAN, Biosense-Webster, BioTel Heart, Biotronik, Boston Scientific, Cairdac, Cardiofocus, Cardionomic, CoreMap, Fire1, Gore & Associates, Impulse Dynamics, Medtronic, Novartis, Philips, Pulse Biosciences; and has equity in DRS Vascular, Manual Surgical Sciences, Newpace, Nyra Medical, Surecor, and Vizaramed. Dr Reinoud E. Knops reports research grants, consulting fees, and serves as a steering committee member of Boston Scientific; and reports speaking fees from Medtronic. Dr Robert Canby reports consulting fees from Medtronic. Dr Thomas Callahan reports speaking and consulting feeds from Medtronic, Philips, Boston Scientific, and ShockWave. Dr Sri Sundaram holds an unrelated patent with Abbott. Dr James E. Ip reports consulting fees from Medtronic and serves as a data safety monitoring committee member of Boston Scientific. All other authors have no conflicts of interest to disclose., (Copyright © 2024 Heart Rhythm Society. Published by Elsevier Inc. All rights reserved.)
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- 2024
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25. Early real-world implant experience with a helix-fixation ventricular leadless pacemaker.
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Nair DG, Exner DV, Reddy VY, Badie N, Ligon D, Miller MA, Lee B, Doty B, Thomaides A, Eldadah Z, Islam M, and Hadadi C
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Background: Roughly one in six patients receiving conventional transvenous pacemaker systems experience significant complications within 1 year of implant, mainly due to the transvenous lead and subcutaneous pocket. A new helix-fixation single-chamber ventricular leadless pacemaker (LP) system capable of pre-deployment exploratory electrical mapping is commercially available. Such an LP may mitigate complications while streamlining the implantation. In this study, the initial real-world implant experience of the helix-fixation LP was evaluated following its commercial release., Methods: In patients indicated for single-chamber right ventricular pacing, helix-fixation Aveir VR LPs (Abbott, Abbott Park, IL) were implanted using the dedicated loading tool, introducer, and delivery catheter. Implant procedural characteristics, electrical parameters, and any 30-day procedure-related adverse events of consecutive implant attempts were retrospectively evaluated., Results: A total of 167 patients with Class I indication for permanent pacing received implants in four North American centers (57% male, 70 years old). Pre-fixation electrical mapping of potential sites allowed repositioning to be avoided in 95.7% of patients. Median [interquartile range] LP procedure and fluoroscopy durations were 25.5 min [20.0, 35.0] and 5.7 min [4.0, 9.2], respectively. Pacing capture threshold, sensed R-wave amplitude, and impedance were 0.8 V [0.5, 1.3], 9.0 mV [6.0, 12.0], and 705 Ω [550, 910], respectively. Implantation was successful in 98.8% of patients, with 98.2% free from acute adverse events., Conclusions: The initial, real-world experience of the helix-fixation ventricular leadless pacemaker demonstrated safe and efficient implantation with minimal repositioning, viable electrical metrics, and limited acute complications., (© 2024. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.)
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- 2024
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26. Long-Term Outcomes of Resynchronization-Defibrillation for Heart Failure.
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Sapp JL, Sivakumaran S, Redpath CJ, Khan H, Parkash R, Exner DV, Healey JS, Thibault B, Sterns LD, Lam NHN, Manlucu J, Mokhtar A, Sumner G, McKinlay S, Kimber S, Mondesert B, Talajic M, Rouleau J, McCarron CE, Wells G, and Tang ASL
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- Humans, Kaplan-Meier Estimate, Stroke Volume, Treatment Outcome, Ventricular Function, Left, Electrocardiography, Follow-Up Studies, Time Factors, Cardiac Resynchronization Therapy, Defibrillators, Implantable, Heart Failure mortality, Heart Failure physiopathology, Heart Failure therapy
- Abstract
Background: The Resynchronization-Defibrillation for Ambulatory Heart Failure Trial (RAFT) showed a greater benefit with respect to mortality at 5 years among patients who received cardiac-resynchronization therapy (CRT) than among those who received implantable cardioverter-defibrillators (ICDs). However, the effect of CRT on long-term survival is not known., Methods: We randomly assigned patients with New York Heart Association (NYHA) class II or III heart failure, a left ventricular ejection fraction of 30% or less, and an intrinsic QRS duration of 120 msec or more (or a paced QRS duration of 200 msec or more) to receive either an ICD alone or a CRT defibrillator (CRT-D). We assessed long-term outcomes among patients at the eight highest-enrolling participating sites. The primary outcome was death from any cause; the secondary outcome was a composite of death from any cause, heart transplantation, or implantation of a ventricular assist device., Results: The trial enrolled 1798 patients, of whom 1050 were included in the long-term survival trial; the median duration of follow-up for the 1050 patients was 7.7 years (interquartile range, 3.9 to 12.8), and the median duration of follow-up for those who survived was 13.9 years (interquartile range, 12.8 to 15.7). Death occurred in 405 of 530 patients (76.4%) assigned to the ICD group and in 370 of 520 patients (71.2%) assigned to the CRT-D group. The time until death appeared to be longer for those assigned to receive a CRT-D than for those assigned to receive an ICD (acceleration factor, 0.80; 95% confidence interval, 0.69 to 0.92; P = 0.002). A secondary-outcome event occurred in 412 patients (77.7%) in the ICD group and in 392 (75.4%) in the CRT-D group., Conclusions: Among patients with a reduced ejection fraction, a widened QRS complex, and NYHA class II or III heart failure, the survival benefit associated with receipt of a CRT-D as compared with ICD appeared to be sustained during a median of nearly 14 years of follow-up. (RAFT ClinicalTrials.gov number, NCT00251251.)., (Copyright © 2024 Massachusetts Medical Society.)
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- 2024
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27. The economic burden of cardiac implantable electronic device infections in Alberta, Canada: a population-based study using validated administrative data.
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Rennert-May E, Chew D, Cannon K, Zhang Z, Smith S, King T, Exner DV, Larios OE, and Leal J
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- Adult, Humans, Alberta epidemiology, Hospitalization, Surgical Wound Infection epidemiology, Financial Stress, Communicable Diseases
- Abstract
Background: Cardiac implantable electronic devices (CIED) are being inserted with increasing frequency. Severe surgical site infections (SSI) that occur after device implantation substantially impact patient morbidity and mortality and can result in multiple hospital admissions and repeat surgeries. It is important to understand the costs associated with these infections as well as healthcare utilization. Therefore, we conducted a population-based study in the province of Alberta, Canada to understand the economic burden of these infections., Methods: A cohort of adult patients in Alberta who had CIEDs inserted or generators replaced between January 1, 2011 and December 31, 2019 was used. A validated algorithm of International Classification of Diseases (ICD) codes to identify complex (deep/organ space) SSIs that occurred within the subsequent year was applied to the cohort. The overall mean 12-month inpatient and outpatient costs for the infection and non-infection groups were assessed. In order to control for variables that may influence costs, propensity score matching was completed and incremental costs between those with and without infection were calculated. As secondary outcomes, number of outpatient visits, hospitalizations and length of stay were assessed., Results: There were 26,049 procedures performed during our study period, of which 320 (1.23%) resulted in SSIs. In both unadjusted costs and propensity score matched costs the infection group was associated with increased costs. Overall mean cost was $145,312 in the infection group versus $34,264 in the non-infection group. The incremental difference in those with infection versus those without in the propensity score match was $90,620 (Standard deviation $190,185). Approximately 70% of costs were driven by inpatient hospitalizations. Inpatients hospitalizations, length of stay and outpatient visits were all increased in the infection group., Conclusions: CIED infections are associated with increased costs and are a burden to the healthcare system. This highlights a need to recognize increasing SSI rates and implement measures to minimize infection risk. Further studies should endeavor to apply this work to full economic evaluations to better understand and identify cost-effective infection mitigation strategies., (© 2023. The Author(s).)
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- 2023
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28. Retrieval of Chronically Implanted Dual-chamber Leadless Pacemakers in an Ovine Model.
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Banker RS, Rippy MK, Cooper N, Neužil P, Exner DV, Nair DG, Booth DF, Ligon D, Badie N, Krans M, Ando K, Knops RE, Ip JE, Doshi RN, Rashtian M, and Reddy VY
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- Humans, Sheep, Animals, Lipopolysaccharides, Sheep, Domestic, Heart Ventricles, Equipment Design, Atrial Fibrillation, Pacemaker, Artificial
- Abstract
Background: The clinical utilization of leadless pacemakers (LPs) as an alternative to traditional transvenous pacemakers is likely to increase with the advent of dual-chamber LP systems. Since device retrieval to allow LP upgrade or replacement will become an important capability, the first such dual-chamber, helix-fixation LP system (Aveir DR; Abbott, Abbott Park, IL) was specifically designed to allow catheter-based retrieval. In this study, the preclinical performance and safety of retrieving chronically implanted dual-chamber LPs was evaluated., Methods: Atrial and ventricular LPs were implanted in the right atrial appendage and right ventricular apex of 9 healthy ovine subjects. After ≈2 years, the LPs were retrieved using a dedicated transvenous retrieval catheter (Aveir Retrieval Catheter; Abbott) by snaring, docking, and unscrewing from the myocardium. Comprehensive necropsy/histopathology studies were conducted to evaluate device- and procedure-related outcomes., Results: At a median of 1.9 years postimplant (range, 1.8-2.6), all 18 of 18 (100%) LPs were retrieved from 9 ovine subjects without complications. The median retrieval procedure duration for both LPs, from first-catheter-in to last-catheter-out, was 13.3 minutes (range, 2.5-36.4). Postretrieval, all right atrial, and right ventricular implant sites demonstrated minimal tissue disruption, with intact fibrous tissue limited to the distal device body. No significant device-related trauma, perforation, pericardial effusion, right heart or tricuspid valve injury, or chronic pulmonary thromboembolism were observed at necropsy., Conclusions: This preclinical study demonstrated the safe and effective retrieval of chronically implanted, helix-fixation, dual-chamber LP systems, paving the way for clinical studies of LP retrieval., Competing Interests: Disclosures Dr Banker reports consulting fees and research support from Abbott, Boston Scientific, and Medtronic. Dr Rippy reports consulting fees from Abbott. Dr Neužil reports consulting fees from Abbott. Dr Exner reports consulting fees and research grants from Abbott, Boston Scientific, and Medtronic. Dr Nair reports consulting fees, honoraria, research grants and support from and serving on advisory boards for Abbott, Adagio Medical, Biosense Webster, Boston Scientific, and Medtronic. Dr Knops reports consulting fees, research grants, and honoraria from Abbott, Boston Scientific, and Medtronic. Dr Ip reports honoraria, serving as a consultant and on a steering committee for Abbott; and consulting fees and honoraria for Medtronic; and serving on a data safety monitoring committee for Boston Scientific. Dr Doshi reports consulting fees and fellowship support from Abbott, Boston Scientific, and Medtronic. Dr Rashtian reports consulting fees and research grants from Abbott. Dr Reddy has served as a consultant to Abbott; in addition, unrelated to this article, Dr Reddy has served as a consultant for and has equity in Ablacon, Acutus Medical, Affera-Medtronic, Anumana, Apama Medical-Boston Scientific, APN Health, Aquaheart, Atacor, Autonomix, Axon Therapies, Backbeat, BioSig, CardiaCare, CardioNXT/AFTx, Circa Scientific, CoRISMA, Corvia Medical, Dinova-Hangzhou DiNovA EP Technology, East End Medical, EPD-Philips, EP Frontiers, Epix Therapeutics-Medtronic, EpiEP, Eximo, Farapulse-Boston Scientific, Field Medical, Focused Therapeutics, HRT, Intershunt, Javelin, Kardium, Keystone Heart, LuxMed, Medlumics, Middlepeak, Neutrace, Nuvera-Biosense Webster, Oracle Health, Restore Medical, Sirona Medical, SoundCath, Valcare; unrelated to this work, has served as a consultant for AtriAN, Biosense-Webster, BioTel Heart, Biotronik, Boston Scientific, Cairdac, Cardiofocus, Cardionomic, CoreMap, Fire1, Gore & Associates, Impulse Dynamics, Medtronic, Novartis, Philips, Pulse Biosciences; and has equity in Manual Surgical Sciences, Newpace, Nyra Medical, Surecor, and Vizaramed. N. Cooper, D.F. Booth, D. Ligon, Dr Badie, and M. Krans are all employees of Abbott. The other author report no conflicts.
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- 2023
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29. Complex cardiac implantable electronic device infections in Alberta, Canada: An epidemiologic cohort study of validated administrative data.
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King TL, Chew DS, Leal J, Cannon K, Exner DV, Smith S, Larios O, Bush K, Yuen B, Zhang Z, and Rennert-May E
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- Adult, Humans, Child, Preschool, Child, Cohort Studies, Retrospective Studies, Alberta epidemiology, Risk Factors, Defibrillators, Implantable adverse effects, Prosthesis-Related Infections epidemiology, Pacemaker, Artificial adverse effects
- Abstract
Objective: To establish the epidemiology of cardiac implantable electronic device (CIED) infections in Alberta, Canada, using validated administrative data., Design: Retrospective, population-based cohort study., Setting: Alberta Health Services is a province-wide health system that services all of Alberta, Canada., Participants: Adult patients who underwent first-time CIED implantation or generator replacement in Alberta, Canada, between January 1, 2011, and December 31, 2019., Methods: CIED implant patients were identified from the Paceart database. Patients who developed an infection within 1 year of the index procedure were identified through validated administrative data (International Classification of Diseases, Tenth Revision in Canada). Demographic characteristics of patients were summarized. Logistic regression models were used to analyze device type, comorbidities, and demographics associated with infection rates and mortality., Results: Among 27,830 CIED implants, there were 205 infections (0.74%). Having 2 or more comorbidities was associated with higher infection risk. Generator replacement procedures (odds ratio [OR], 0.55; 95% confidence interval [CI], 0.34-0.84; P = .008), age increase of every 10 years (OR, 0.73; 95% CI, 0.66-0.82; P ≤ .001), and index procedure after 2014 were associated with decreased risk. Comparing the infected to uninfected groups, the hospitalization rates were 2.63 compared to 0.69, and the mortality rates were 10.73% compared to 3.49%, respectively (P < .001)., Conclusions: There is a slightly lower overall rate of CIED infections Alberta, Canada compared to previously described epidemiology. Implants after 2014, and generator replacements showed a decreased burden of infection. Patients with younger age, and 2 or more comorbidities are at greatest risk of CIED infection. The burden of hospitalization and mortality is substantially higher in infected patients.
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- 2023
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30. Dual-chamber leadless pacing: Atrioventricular synchrony in preclinical models of normal or blocked atrioventricular conduction.
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Reddy VY, Neuzil P, Booth DF, Knops RE, Doshi RN, Rashtian M, Exner DV, Banker RS, Nair D, Hadadi CA, Badie N, Yang W, Ligon D, and Ip JE
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- Humans, Animals, Sheep, Cardiac Pacing, Artificial methods, Lipopolysaccharides, Heart Rate, Pacemaker, Artificial, Atrioventricular Block therapy
- Abstract
Background: Dual-chamber leadless pacemakers (LPs) require robust communication between distinct right atrial (RA) and right ventricular (RV) LPs to achieve atrioventricular (AV) synchrony., Objective: The purpose of this preclinical study was to evaluate a novel, continuous implant-to-implant (i2i™) communication methodology for maintaining AV-synchronous, dual-chamber DDD(R) pacing by the 2 LPs., Methods: RA and RV LPs were implanted and paired in 7 ovine subjects (4 with induced complete heart block). AV synchrony (% AV intervals <300 ms) and i2i communication success (% successful i2i transmissions between LPs) were evaluated acutely and chronically. During acute testing, 12-lead electrocardiographic and LP diagnostic data were collected from 5-minute recordings, in 4 postures and 2 rhythms (AP-VP and AS-VP, or AP-VS and AS-VS) per subject. Chronic i2i performance was evaluated through 23 weeks postimplant (final i2i evaluation period: week 16-23)., Results: Acute AV synchrony and i2i communication success across multiple postures and rhythms were median [interquartile range] 100.0% [100.0%-100.0%] and 99.9% [99.9%-99.9%], respectively. AV synchrony and i2i success rates did not differ across postures (P = .59, P = .11) or rhythms (P = 1, P = .82). During the final i2i evaluation period, the overall i2i success was 98.9% [98.1%-99.0%]., Conclusion: Successful AV-synchronous, dual-chamber DDD(R) leadless pacing using a novel, continuous, wireless communication modality was demonstrated across variations in posture and rhythm in a preclinical model., (Copyright © 2023. Published by Elsevier Inc.)
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- 2023
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31. 1-Year Outcomes of a Leadless Ventricular Pacemaker: The LEADLESS II (Phase 2) Trial.
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Reddy VY, Exner DV, Doshi R, Tomassoni G, Bunch TJ, Friedman P, Estes NAM, Neužil P, de la Concha JF, and Cantillon DJ
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- Humans, Cardiac Pacing, Artificial, Pacemaker, Artificial
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- 2023
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32. Successes and challenges of artificial intelligence in cardiology.
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Vandenberk B, Chew DS, Prasana D, Gupta S, and Exner DV
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In the past decades there has been a substantial evolution in data management and data processing techniques. New data architectures made analysis of big data feasible, healthcare is orienting towards personalized medicine with digital health initiatives, and artificial intelligence (AI) is becoming of increasing importance. Despite being a trendy research topic, only very few applications reach the stage where they are implemented in clinical practice. This review provides an overview of current methodologies and identifies clinical and organizational challenges for AI in healthcare., Competing Interests: DP and SG are employed by Intelense Inc. DP is employed by IOT/AI - Caliber Interconnect Pvt Ltd. The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (© 2023 Vandenberk, Chew, Prasana, Gupta and Exner.)
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- 2023
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33. A Dual-Chamber Leadless Pacemaker.
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Knops RE, Reddy VY, Ip JE, Doshi R, Exner DV, Defaye P, Canby R, Bongiorni MG, Shoda M, Hindricks G, Neužil P, Rashtian M, Breeman KTN, Nevo JR, Ganz L, Hubbard C, and Cantillon DJ
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- Humans, Atrial Fibrillation therapy, Atrial Fibrillation etiology, Atrioventricular Block therapy, Follow-Up Studies, Prospective Studies, Treatment Outcome, Cardiac Pacing, Artificial adverse effects, Cardiac Pacing, Artificial methods, Pacemaker, Artificial adverse effects, Arrhythmias, Cardiac therapy
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Background: Single-chamber ventricular leadless pacemakers do not support atrial pacing or consistent atrioventricular synchrony. A dual-chamber leadless pacemaker system consisting of two devices implanted percutaneously, one in the right atrium and one in the right ventricle, would make leadless pacemaker therapy a treatment option for a wider range of indications., Methods: We conducted a prospective, multicenter, single-group study to evaluate the safety and performance of a dual-chamber leadless pacemaker system. Patients with a conventional indication for dual-chamber pacing were eligible for participation. The primary safety end point was freedom from complications (i.e., device- or procedure-related serious adverse events) at 90 days. The first primary performance end point was a combination of adequate atrial capture threshold and sensing amplitude at 3 months. The second primary performance end point was at least 70% atrioventricular synchrony at 3 months while the patient was sitting., Results: Among the 300 patients enrolled, 190 (63.3%) had sinus-node dysfunction and 100 (33.3%) had atrioventricular block as the primary pacing indication. The implantation procedure was successful (i.e., two functioning leadless pacemakers were implanted and had established implant-to-implant communication) in 295 patients (98.3%). A total of 35 device- or procedure-related serious adverse events occurred in 29 patients. The primary safety end point was met in 271 patients (90.3%; 95% confidence interval [CI], 87.0 to 93.7), which exceeded the performance goal of 78% (P<0.001). The first primary performance end point was met in 90.2% of the patients (95% CI, 86.8 to 93.6), which exceeded the performance goal of 82.5% (P<0.001). The mean (±SD) atrial capture threshold was 0.82±0.70 V, and the mean P-wave amplitude was 3.58±1.88 mV. Of the 21 patients (7%) with a P-wave amplitude of less than 1.0 mV, none required device revision for inadequate sensing. At least 70% atrioventricular synchrony was achieved in 97.3% of the patients (95% CI, 95.4 to 99.3), which exceeded the performance goal of 83% (P<0.001)., Conclusions: The dual-chamber leadless pacemaker system met the primary safety end point and provided atrial pacing and reliable atrioventricular synchrony for 3 months after implantation. (Funded by Abbott Medical; Aveir DR i2i ClinicalTrials.gov number, NCT05252702.)., (Copyright © 2023 Massachusetts Medical Society.)
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- 2023
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34. Eliminating Medication Copayments for Low-Income Older Adults at High Cardiovascular Risk: A Randomized Controlled Trial.
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Campbell DJT, Mitchell C, Hemmelgarn BR, Tonelli M, Faris P, Zhang J, Tsuyuki RT, Fletcher J, Au F, Klarenbach S, Exner DV, and Manns BJ
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- Humans, Aged, Quality of Life, Risk Factors, Alberta, Cardiovascular Diseases drug therapy, Cardiovascular Diseases epidemiology, Cardiovascular Diseases prevention & control, Myocardial Infarction drug therapy, Myocardial Infarction epidemiology, Myocardial Infarction prevention & control, Stroke epidemiology, Stroke prevention & control
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Background: One in eight people with heart disease has poor medication adherence that, in part, is related to copayment costs. This study tested whether eliminating copayments for high-value medications among low-income older adults at high cardiovascular risk would improve clinical outcomes., Methods: This randomized 2×2 factorial trial studied 2 distinct interventions in Alberta, Canada: eliminating copayments for high-value preventive medications and a self-management education and support program (reported separately). The findings for the first intervention, which waived the usual 30% copayment on 15 medication classes commonly used to reduce cardiovascular events, compared with usual copayment, is reported here. The primary outcome was the composite of death, myocardial infarction, stroke, coronary revascularization, and cardiovascular-related hospitalizations over a 3-year follow-up. Rates of the primary outcome and its components were compared using negative binomial regression. Secondary outcomes included quality of life (Euroqol 5-dimension index score), medication adherence, and overall health care costs., Results: A total of 4761 individuals were randomized and followed for a median of 36 months. There was no evidence of statistical interaction ( P =0.99) or of a synergistic effect between the 2 interventions in the factorial trial with respect to the primary outcome, which allowed us to evaluate the effect of each intervention separately. The rate of the primary outcome was not reduced by copayment elimination, (521 versus 533 events, incidence rate ratio 0.84 [95% CI, 0.66-1.07], P =0.162). The incidence rate ratio for nonfatal myocardial infarction, nonfatal stroke, and cardiovascular death (0.97 [95% CI, 0.67-1.39]), death (0.94 [95% CI, 0.80 to 1.11]), and cardiovascular-related hospitalizations (0.78 [95% CI, 0.57 to 1.06]) did not differ between groups. No significant between-group changes in quality of life over time were observed (mean difference, 0.012 [95% CI, -0.006 to 0.030], P =0.19). The proportion of participants who were adherent to statins was 0.72 versus 0.69 for the copayment elimination versus usual copayment groups, respectively (mean difference, 0.03 [95% CI, 0.006-0.06], P =0.016). Overall adjusted health care costs did not differ ($3575 [95% CI, -605 to 7168], P =0.098)., Conclusions: In low-income adults at high cardiovascular risk, eliminating copayments (average, $35/mo) did not improve clinical outcomes or reduce health care costs, despite a modest improvement in adherence to medications., Registration: URL: https://www., Clinicaltrials: gov; Unique identifier: NCT02579655., Competing Interests: Disclosures M.T. has received honoraria for lectures not related to the topic of the current article from AstraZeneca and received honoraria donated to charity. C.M. is an employee of Alberta Health, presently in the capacity of Assistant Deputy Minister of the Pharmaceutical Branch. R.T.T. is a consultant for Shoppers Drug Mart and Emergent Biosolutions. R.T.T. has received investigator-initiated arms-length grants from Merck, Sanofi, AstraZeneca, and Pfizer. The other authors report no conflicts.
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- 2023
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35. Self-Management Support Using Advertising Principles for Older Adults With Low Income at High Cardiovascular Risk: A Randomized Controlled Trial.
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Campbell DJT, Tonelli M, Hemmelgarn BR, Faris P, Zhang J, Au F, Tsuyuki RT, Mitchell C, Pannu R, Campbell T, Ivers N, Fletcher J, Exner DV, and Manns BJ
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- Humans, Female, Aged, Male, Quality of Life, Advertising, Risk Factors, Heart Disease Risk Factors, Alberta, Cardiovascular Diseases epidemiology, Cardiovascular Diseases prevention & control, Self-Management
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Background: Self-management education and support (SMES) interventions have modest effects on intermediate outcomes for those at risk of cardiovascular disease, but few studies have measured or demonstrated an effect on clinical end points. Advertising for commercial products is known to influence behavior, but advertising principles are not typically incorporated into SMES design., Methods: This randomized trial studied the effect of a novel tailored SMES program designed by an advertising firm among a population of older adults with low income at high cardiovascular risk in Alberta, Canada. The intervention included health promotion messaging from a fictitious "peer" and facilitated relay of clinical information to patients' primary care provider and pharmacist. The primary outcome was the composite of death, myocardial infarction, stroke, coronary revascularization, and hospitalizations for cardiovascular-related ambulatory care-sensitive conditions. Rates of the primary outcome and its components were compared using negative binomial regression. Secondary outcomes included quality of life (EQ-5D [EuroQoL 5-dimension] index score), medication adherence, and overall health care costs., Results: We randomized 4761 individuals, with a mean age of 74.4 years, of whom 46.8% were female. There was no evidence of statistical interaction ( P =0.99) or of a synergistic effect between the 2 interventions in the factorial trial with respect to the primary outcome, which allowed us to evaluate the effect of each intervention separately. Over a median follow-up time of 36 months, the rate of the primary outcome was lower in the group that received SMES compared with the control group (incidence rate ratio, 0.78 [95% CI, 0.61 to 1.00]; P =0.047). No significant between-group changes in quality of life over time were observed (mean difference, 0.0001 [95% CI, -0.018 to 0.018]; P =0.99). The proportion of participants who were adherent to medications was not different between the 2 groups ( P =0.199 for statins and P =0.754 for angiotensin-converting enzyme inhibitors/angiotensin receptor blockers). Overall adjusted health care costs did not differ between those receiving SMES and the control group ($2015 [95% CI, -$1953 to $5985]; P =0.320)., Conclusions: For older adults with low income, a tailored SMES program using advertising principles reduced the rate of clinical outcomes compared with usual care. The mechanisms of improvement are unclear and further studies are required., Registration: URL: https://www., Clinicaltrials: gov; Unique identifier: NCT02579655., Competing Interests: Disclosures Dr Tonelli has received honoraria for lectures not related to the topic of the current article from AstraZeneca and received honoraria donated to charity. C. Mitchell is an employee of Alberta Health, currently in the capacity of assistant deputy minister of the pharmaceutical branch. Dr Tsuyuki is a consultant for Shoppers Drug Mart and Emergent Biosolutions. He has received investigator-initiated arms-length grants from Merck, Sanofi, AstraZeneca, and Pfizer. Dr Pannu is president and chief executive officer of Emergence Creative.
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- 2023
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36. Association of the Timing and Extent of Cardiac Implantable Electronic Device Infections With Mortality.
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Han HC, Wang J, Birnie DH, Alings M, Philippon F, Parkash R, Manlucu J, Angaran P, Rinne C, Coutu B, Low RA, Essebag V, Morillo C, Healey JS, Redfearn D, Toal S, Becker G, DeGrâce M, Thibault B, Crystal E, Tung S, LeMaitre J, Sultan O, Bennett M, Bashir J, Ayala-Paredes F, Gervais P, Rioux L, Hemels MEW, Bouwels LHR, Exner DV, Dorian P, Connolly SJ, Longtin Y, and Krahn AD
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- Humans, Male, Aged, Female, Prospective Studies, Canada, Netherlands, Defibrillators, Implantable adverse effects, Heart Diseases etiology
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Importance: Cardiac implantable electronic device (CIED) infection is a potentially devastating complication with an estimated 12-month mortality of 15% to 30%. The association of the extent (localized or systemic) and timing of infection with all-cause mortality has not been established., Objective: To evaluate the association of the extent and timing of CIED infection with all-cause mortality., Design, Setting, and Participants: This prospective observational cohort study was conducted between December 1, 2012, and September 30, 2016, in 28 centers across Canada and the Netherlands. The study included 19 559 patients undergoing CIED procedures, 177 of whom developed an infection. Data were analyzed from April 5, 2021, to January 14, 2023., Exposures: Prospectively identified CIED infections., Main Outcomes and Measures: Time-dependent analysis of the timing (early [≤3 months] or delayed [3-12 months]) and extent (localized or systemic) of infection was performed to determine the risk of all-cause mortality associated with CIED infections., Results: Of 19 559 patients undergoing CIED procedures, 177 developed a CIED infection. The mean (SD) age was 68.7 (12.7) years, and 132 patients were male (74.6%). The cumulative incidence of infection was 0.6%, 0.7%, and 0.9% within 3, 6, and 12 months, respectively. Infection rates were highest in the first 3 months (0.21% per month), reducing significantly thereafter. Compared with patients who did not develop CIED infection, those with early localized infections were not at higher risk for all-cause mortality (no deaths at 30 days [0 of 74 patients]: adjusted hazard ratio [aHR], 0.64 [95% CI, 0.20-1.98]; P = .43). However, patients with early systemic and delayed localized infections had an approximately 3-fold increase in mortality (8.9% 30-day mortality [4 of 45 patients]: aHR, 2.88 [95% CI, 1.48-5.61]; P = .002; 8.8% 30-day mortality [3 of 34 patients]: aHR, 3.57 [95% CI, 1.33-9.57]; P = .01), increasing to a 9.3-fold risk of death for those with delayed systemic infections (21.7% 30-day mortality [5 of 23 patients]: aHR, 9.30 [95% CI, 3.82-22.65]; P < .001)., Conclusions and Relevance: Findings suggest that CIED infections are most common within 3 months after the procedure. Early systemic infections and delayed localized infections are associated with increased mortality, with the highest risk for patients with delayed systemic infections. Early detection and treatment of CIED infections may be important in reducing mortality associated with this complication.
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- 2023
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37. Perioperative Safety and Early Patient and Device Outcomes Among Subcutaneous Versus Transvenous Implantable Cardioverter Defibrillator Implantations : A Randomized, Multicenter Trial.
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Healey JS, Krahn AD, Bashir J, Amit G, Philippon F, McIntyre WF, Tsang B, Joza J, Exner DV, Birnie DH, Sadek M, Leong DP, Sikkel M, Korley V, Sapp JL, Roux JF, Lee SF, Wong G, Djuric A, Spears D, Carroll S, Crystal E, Hruczkowski T, Connolly SJ, and Mondesert B
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- Female, Humans, Treatment Outcome, Arrhythmias, Cardiac, Risk Factors, Death, Sudden, Cardiac etiology, Defibrillators, Implantable adverse effects, Heart Arrest
- Abstract
Background: Implantable cardioverter defibrillators (ICDs) improve survival in patients at risk for cardiac arrest, but are associated with intravascular lead-related complications. The subcutaneous ICD (S-ICD), with no intravascular components, was developed to minimize lead-related complications., Objective: To assess key ICD performance measures related to delivery of ICD therapy, including inappropriate ICD shocks (delivered in absence of life-threatening arrhythmia) and failed ICD shocks (which did not terminate ventricular arrhythmia)., Design: Randomized, multicenter trial. (ClinicalTrials.gov: NCT02881255)., Setting: The ATLAS trial., Patients: 544 eligible patients (141 female) with a primary or secondary prevention indication for an ICD who were younger than age 60 years, had a cardiogenetic phenotype, or had prespecified risk factors for lead complications were electrocardiographically screened and 503 randomly assigned to S-ICD (251 patients) or transvenous ICD (TV-ICD) (252 patients). Mean follow-up was 2.5 years (SD, 1.1). Mean age was 49.0 years (SD, 11.5)., Measurements: The primary outcome was perioperative major lead-related complications., Results: There was a statistically significant reduction in perioperative, lead-related complications, which occurred in 1 patient (0.4%) with an S-ICD and in 12 patients (4.8%) with TV-ICD (-4.4%; 95% CI, -6.9 to -1.9; P = 0.001). There was a trend for more inappropriate shocks with the S-ICD (hazard ratio [HR], 2.37; 95% CI, 0.98 to 5.77), but no increase in failed appropriate ICD shocks (HR, 0.61 (0.15 to 2.57). Patients in the S-ICD group had more ICD site pain, measured on a 10-point numeric rating scale, on the day of implant (4.2 ± 2.8 vs. 2.9 ± 2.2; P < 0.001) and 1 month later (1.3 ± 1.8 vs. 0.9 ± 1.5; P = 0.035)., Limitation: At present, the ATLAS trial is underpowered to detect differences in clinical shock outcomes; however, extended follow-up is ongoing., Conclusion: The S-ICD reduces perioperative, lead-related complications without significantly compromising the effectiveness of ICD shocks, but with more early postoperative pain and a trend for more inappropriate shocks., Primary Funding Source: Boston Scientific.
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- 2022
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38. Machine learning prediction of atrial fibrillation in cardiovascular patients using cardiac magnetic resonance and electronic health information.
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Dykstra S, Satriano A, Cornhill AK, Lei LY, Labib D, Mikami Y, Flewitt J, Rivest S, Sandonato R, Feuchter P, Howarth AG, Lydell CP, Fine NM, Exner DV, Morillo CA, Wilton SB, Gavrilova ML, and White JA
- Abstract
Background: Atrial fibrillation (AF) is a commonly encountered cardiac arrhythmia associated with morbidity and substantial healthcare costs. While patients with cardiovascular disease experience the greatest risk of new-onset AF, no risk model has been developed to predict AF occurrence in this population. We hypothesized that a patient-specific model could be delivered using cardiovascular magnetic resonance (CMR) disease phenotyping, contextual patient health information, and machine learning., Methods: Nine thousand four hundred forty-eight patients referred for CMR imaging were enrolled and followed over a 5-year period. Seven thousand, six hundred thirty-nine had no prior history of AF and were eligible to train and validate machine learning algorithms. Random survival forests (RSFs) were used to predict new-onset AF and compared to Cox proportional-hazard (CPH) models. The best performing features were identified from 115 variables sourced from three data domains: (i) CMR-based disease phenotype, (ii) patient health questionnaire, and (iii) electronic health records. We evaluated discriminative performance of optimized models using C-index and time-dependent AUC (tAUC)., Results: A RSF-based model of 20 variables (CIROC-AF-20) delivered an overall C-index of 0.78 for the prediction of new-onset AF with respective tAUCs of 0.80, 0.79, and 0.78 at 1-, 2- and 3-years. This outperformed a novel CPH-based model and historic AF risk scores. At 1-year of follow-up, validation cohort patients classified as high-risk of future AF by CIROC-AF-20 went on to experience a 17.3% incidence of new-onset AF, being 24.7-fold higher risk than low risk patients., Conclusions: Using phenotypic data available at time of CMR imaging we developed and validated the first described risk model for the prediction of new-onset AF in patients with cardiovascular disease. Complementary value was provided by variables from patient-reported measures of health and the electronic health record, illustrating the value of multi-domain phenotypic data for the prediction of AF., Competing Interests: Authors JW, AH, and JF each contributed to development of the novel software platform that is now supported by Cohesic Inc., and hold equity (shares) in this company. Author JW is the Chief Medical Officer of Cohesic Inc. Author JW has received research funding from Siemens Healthineers, Circle Cardiovascular Inc., and Pfizer Inc. Author AH has received funding from Amgen. Author SD receives funding from Alberta Innovates. The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2022 Dykstra, Satriano, Cornhill, Lei, Labib, Mikami, Flewitt, Rivest, Sandonato, Feuchter, Howarth, Lydell, Fine, Exner, Morillo, Wilton, Gavrilova and White.)
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- 2022
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39. Geographic and temporal variation in the treatment and outcomes of atrial fibrillation: a population-based analysis of national quality indicators.
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Chew DS, Au F, Xu Y, Manns BJ, Tonelli M, Wilton SB, Hemmelgarn B, Kong S, Exner DV, and Quinn AE
- Subjects
- Adult, Aged, Alberta epidemiology, Anticoagulants adverse effects, Anticoagulants therapeutic use, Female, Hemorrhage chemically induced, Hemorrhage epidemiology, Humans, Male, Quality Indicators, Health Care, Treatment Outcome, Atrial Fibrillation diagnosis, Atrial Fibrillation drug therapy, Atrial Fibrillation epidemiology, Ischemic Stroke, Stroke epidemiology, Stroke etiology, Stroke prevention & control
- Abstract
Background: Assessment of potential geographic variation in quality indicators of atrial fibrillation care may identify opportunities for improvement in the quality of atrial fibrillation care. The objective of this study was to assess for potential geographic variation in the quality of atrial fibrillation care in Alberta, Canada., Methods: In a population-based cohort of adults (age ≥ 18 yr) with incident nonvalvular atrial fibrillation (NVAF) diagnosed between Apr. 1, 2008, and Mar. 31, 2016, in Alberta, we investigated the variation in national quality indicators of atrial fibrillation care developed by the Canadian Cardiovascular Society. Specifically, we assessed the geographic and temporal variation in the proportion of patients with initiation of oral anticoagulant therapy, persistence with therapy, ischemic stroke and major bleeding outcomes 1 year after atrial fibrillation diagnosis using linked administrative data sets. We defined stroke risk using the CHADS
2 score. We assessed geographic variation using small-area variation statistics and geospatial data analysis., Results: Of the 64 093 patients in the study cohort (35 019 men [54.6%] and 29 074 women [45.4%] with a mean age of 69 [standard deviation 15.9] yr), 36 199 were at high risk for stroke and 14 411 were at moderate risk. Within 1 year of NVAF diagnosis, 20 180 patients (55.7%) in the high-risk group and 6448 patients (44.7%) in the moderate-risk group were prescribed anticoagulation. A total of 2187 patients (3.4%) had an ischemic stroke, and 2996 patients (4.7%) experienced a major bleed. There was substantial regional variation observed in initiation of oral anticoagulant therapy but not in the proportion of patients with ischemic stroke or major bleeding. Among the 64 Health Status Areas in Alberta, therapy initiation rates ranged from 22.6% to 71.2% among patients at high stroke risk and from 22.7% to 55.8% among those at moderate stroke risk, with clustering of lower therapy initiation rates in rural northern regions., Interpretation: The rate of initiation of oral anticoagulant therapy among adults with incident atrial fibrillation was less than 60% in patients in whom oral anticoagulant therapy would be considered guideline-appropriate care. The large geographic variation in oral anticoagulant prescribing warrants additional study into patient, provider and health care system factors that contribute to variation and drive disparities in high-quality, equitable atrial fibrillation care., Competing Interests: Competing interests: Derek Exner reports research grants and personal fees from Abbott, GE Healthcare, Medtronic Canada and HelpWear, outside the submitted work. Stephen Wilton reports research grants from Abbott, Medtronic Canada and Boston Scientific, and consulting feeds from ARCA Biopharma, outside the submitted work. No other competing interests were declared., (© 2022 CMA Impact Inc. or its licensors.)- Published
- 2022
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40. ICDs for Patients With Stable VT, Cardiomyopathy, and Relatively Preserved LVEF: Core Therapy, Precision Medicine, or Indication Creep?
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Mitchell LB and Exner DV
- Subjects
- Humans, Precision Medicine, Ventricular Fibrillation, Cardiomyopathies therapy, Defibrillators, Implantable, Tachycardia, Ventricular therapy
- Published
- 2022
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41. Clinical and Economic Outcomes Associated With Remote Monitoring for Cardiac Implantable Electronic Devices: A Population-Based Analysis.
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Chew DS, Zarrabi M, You I, Morton J, Low A, Reyes L, Yuen B, Sumner GL, Raj SR, Exner DV, and Wilton SB
- Subjects
- Alberta epidemiology, Cardiac Resynchronization Therapy Devices, Cohort Studies, Electronics, Humans, Treatment Outcome, Cardiac Resynchronization Therapy, Defibrillators, Implantable
- Abstract
Background: Despite expert recommendations advocating use of remote monitoring (RM) of cardiac implantable electronic devices, implementation in routine clinical practice remains modest due to inconsistent funding policies across health systems and uncertainty regarding the efficacy of RM to reduce adverse cardiovascular outcomes., Methods: We conducted a population-based cohort study of patients with de novo implantable cardioverter-defibrillators (ICDs) with or without cardiac resynchronization therapy (CRT-D), using administrative health data in Alberta, Canada, from 2010 to 2016. We assessed RM status as a predictor of all-cause mortality and cardiovascular (CV) hospitalization using Cox proportional hazards modelling, and direct health costs by generalized linear models. From this real-world data, we then constructed a decision-analytic Markov model to estimate the projected costs and benefits associated with RM compared with in-clinic visit follow-up alone., Results: Among 2799 ICD and CRT-D patients, 1830 (63.4%) were followed by RM for a mean follow-up of 50.3 months. After adjustment for age, sex, and comorbidities, RM was associated with a lower risk of death (hazard ratio [HR] 0.43, 95% confidence interval [CI] 0.36-0.52; P < 0.001) and CV hospitalization (HR 0.76, 95% CI 0.64-0.91; P = 0.002). In the economic model, cost savings were observed over 5 years with an estimated savings of $12,195 per person (95% CI -$21,818 to -$4,790). The model estimated a cost-savings associated with RM strategy in 99% of simulations., Conclusions: These population data support more widespread implementation of RM technology to facilitate better patient outcomes and improve health system efficiency., (Copyright © 2022 Canadian Cardiovascular Society. Published by Elsevier Inc. All rights reserved.)
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- 2022
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42. Lower body muscle preactivation and tensing mitigate symptoms of initial orthostatic hypotension in young females.
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Sheikh NA, Ranada S, Lloyd M, McCarthy D, Kogut K, Bourne KM, Jorge JG, Lei LY, Sheldon RS, Exner DV, Phillips AA, Runté M, and Raj SR
- Subjects
- Blood Pressure physiology, Cardiac Output, Female, Humans, Muscles, Syncope etiology, Syncope therapy, Hypotension, Orthostatic diagnosis, Hypotension, Orthostatic therapy
- Abstract
Background: Initial orthostatic hypotension (IOH) is a form of orthostatic intolerance defined by a transient decrease in blood pressure upon standing. Current clinical recommendations for managing IOH includes standing up slowly or lower body muscle tensing (TENSE) after standing. Considering that IOH is likely due to a large muscle activation response resulting in excessive vasodilation with a refractory period (<2 minutes), we hypothesized that preactivating lower body muscles (PREACT) before standing would reduce the drop in mean arterial pressure (MAP) upon standing and improve presyncope symptoms., Objective: The purpose of this study was to provide IOH patients with effective symptom management techniques., Methods: Study participants completed 3 sit-to-stand maneuvers, including a stand with no intervention (Control), PREACT, and TENSE. Continuous heart rate and beat-to-beat blood pressure were measured. Stroke volume and cardiac output were then estimated from these waveforms., Results: A total of 24 female IOH participants (mean ± SD: 32 ± 8 years) completed the study. The drops in MAP following PREACT (-21 ± 8 mm Hg; P <.001) and TENSE (-18 ± 10 mm Hg; P <.001) were significantly reduced compared to Control (-28 ± 10 mm Hg). The increase in cardiac output was significantly larger following PREACT (2.6 ± 1 L/min; P <.001) but not TENSE (1.9 ± 1 L/min; P = .2) compared to Control (1.4 ± 1 L/min). The Vanderbilt Orthostatic Symptom Score following PREACT (9 ± 8 au; P = .033) and TENSE (8 ± 8 au; P = .046) both were significantly reduced compared to Control (14 ± 9 au)., Conclusion: Both the drop in MAP and symptoms upon standing improved with either PREACT or TENSE. These maneuvers provide novel symptom management techniques for patients with IOH., (Copyright © 2021 Heart Rhythm Society. Published by Elsevier Inc. All rights reserved.)
- Published
- 2022
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43. Mitigating Initial Orthostatic Hypotension: Mechanistic Roles of Muscle Contraction Versus Sympathetic Activation.
- Author
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Sheikh NA, Phillips AA, Ranada S, Lloyd M, Kogut K, Bourne KM, Jorge JG, Lei LY, Sheldon RS, Exner DV, Runte M, and Raj SR
- Subjects
- Adult, Body Mass Index, Electrocardiography, Exercise Test, Female, Humans, Male, Vascular Resistance physiology, Young Adult, Blood Pressure physiology, Heart Rate physiology, Hypotension, Orthostatic physiopathology, Muscle Contraction physiology, Posture physiology, Sympathetic Nervous System physiopathology
- Abstract
Background: Initial orthostatic hypotension (IOH) is defined by a large drop in blood pressure (BP) within 15 s of standing. IOH often presents during an active stand, but not with a passive tilt, suggesting that a muscle activation reflex involving lower body muscles plays an important role. To our knowledge, there is no literature exploring how sympathetic activation affects IOH. We hypothesized involuntary muscle contractions before standing would significantly reduce the drop in BP seen in IOH while increasing sympathetic activity would not., Methods: Study participants performed 4 sit-to-stand maneuvers including a mental stress test (serial 7 mental arithmetic stress test), cold pressor test, electrical stimulation, and no intervention. Continuous heart rate and beat-to-beat BP were measured. Cardiac output and systemic vascular resistance were estimated from these waveforms. Data are presented as mean±SD., Results: A total of 23 female IOH participants (31±8 years) completed the study. The drops in systolic BP following the serial 7 mental arithmetic stress test (-26±12 mm Hg; P =0.004), cold pressor test (-20±15 mm Hg; P <0.001), and electrical stimulation (-28±12 mm Hg; P =0.01) were significantly reduced compared with no intervention (-34±11 mm Hg). The drops in systemic vascular resistance following the serial 7 mental arithmetic stress test (-391±206 dyne×s/cm
5 ; P =0.006) and cold pressor test (-386±179 dyne×s/cm5 ; P =0.011) were significantly reduced compared with no intervention (-488±173 dyne×s/cm5 ). Cardiac output was significantly increased upon standing (7±2 L/min) compared with during the sit (6±1 L/min; P <0.001) for electrical stimulation., Conclusion: Sympathetic activation mitigates the BP response in IOH, while involuntary muscle contraction mitigates the BP response and reduces symptoms. Active muscle contractions may induce both of these mechanisms of action in their pretreatment of IOH. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT03970551.- Published
- 2022
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44. Primary Results on Safety and Efficacy From the LEADLESS II-Phase 2 Worldwide Clinical Trial.
- Author
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Reddy VY, Exner DV, Doshi R, Tomassoni G, Bunch TJ, Estes NAM, Neužil P, Paulin FL, Garcia Guerrero JJ, and Cantillon DJ
- Subjects
- Clinical Trials, Phase II as Topic, Humans, Cardiac Pacing, Artificial adverse effects
- Published
- 2022
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45. Diagnosis-to-ablation time predicts recurrent atrial fibrillation and rehospitalization following catheter ablation.
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Chew DS, Jones KA, Loring Z, Black-Maier E, Noseworthy PA, Exner DV, Packer DL, Grant J, Mark DB, and Piccini JP
- Abstract
Background: Wait times for catheter ablation in patients with symptomatic atrial fibrillation (AF) may influence clinical outcomes., Objective: This study examined the relationship between the duration from AF diagnosis to ablation, or diagnosis-to-ablation time (DAT), on the clinical response to catheter ablation in a large nationwide cohort of patients., Methods: We identified patients with new AF who underwent catheter ablation between January 2014 and December 2017 using the IBM MarketScan databases. Cox proportional hazard models were used to estimate the strength of the association between DAT and the outcomes of AF recurrence and hospitalization at 1 year postablation., Results: Among 11,143 AF patients who underwent ablation, the median age was 59 years, 31% were female, and the median CHA
2 DS2 -VASc score was 2. Median DAT was 5.5 (2.6, 13.1) months. At 1 year postablation, 10.0% (n = 1116) developed recurrent AF. For each year increase in DAT, the risk of AF recurrence increased by 20% after adjustment for baseline comorbidities and medications (hazard ratio [HR] 1.20, 95% confidence interval [CI] 1.11-1.30). A longer DAT was associated with an increased risk of hospitalization (HR 1.08 per DAT year, 95% CI 1.02-1.15). DAT was a stronger predictor of AF recurrence postablation than traditional clinical risk factors, including age, prior heart failure, or renal failure., Conclusion: Increasing duration between AF diagnosis and catheter ablation is associated with higher AF recurrence rates and all-cause hospitalization. Our findings are consistent with a growing body of evidence supporting the benefits of prioritizing early restoration of sinus rhythm., (© 2021 Heart Rhythm Society. Published by Elsevier Inc.)- Published
- 2021
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46. Canadian Heart Rhythm Society Task Force Report on Physician Training and Maintenance of Competency for Cardiovascular Implantable Electronic Device Therapies: Executive Summary.
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Yee R, Karim SS, Bashir J, Bennett MT, Exner DV, Guerra PG, Healey JS, Korkola S, Manlucu J, Parkash R, Philippon F, and Rinne C
- Subjects
- Arrhythmias, Cardiac therapy, Canada, Clinical Competence standards, Electric Countershock standards, Electronics, Guidelines as Topic, Humans, Advisory Committees statistics & numerical data, Cardiology education, Defibrillators, Implantable, Education, Medical, Graduate methods, Pacemaker, Artificial, Physicians standards, Societies, Medical
- Abstract
Physicians engaged in cardiovascular implantable electronic device (CIED)-related practice come from diverse training backgrounds with variable degrees of CIED implant training. The objective of the Canadian Heart Rhythm Society Task Force on CIED Implant Training was to establish a common structure and content for training programs in CIED implantation, related activities and maintenance of competency. This executive summary presents the essence of the report with key recommendations included, with the complete version made available in a linked supplement. The goals are to ensure that future generations of CIED implanters are better prepared for continuously evolving CIED practice and quality care for all Canadians., (Copyright © 2021 The Authors. Published by Elsevier Inc. All rights reserved.)
- Published
- 2021
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47. Impact of Choice of Prophylaxis on the Microbiology of Cardiac Implantable Electronic Device Infections: Insights From the Prevention of Arrhythmia Device Infection Trial (PADIT).
- Author
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Longtin Y, Gervais P, Birnie DH, Wang J, Alings M, Philippon F, Parkash R, Manlucu J, Angaran P, Rinne C, Coutu B, Low RA, Essebag V, Morillo C, Redfearn D, Toal S, Becker G, Degrâce M, Thibault B, Crystal E, Tung S, LeMaitre J, Sultan O, Bennett M, Bashir J, Ayala-Paredes F, Rioux L, Hemels MEW, Bouwels LHR, Exner DV, Dorian P, Connolly SJ, and Krahn AD
- Abstract
Background: The Prevention of Arrhythmia Device Infection Trial (PADIT) investigated whether intensification of perioperative prophylaxis could prevent cardiac implantable electronic device (CIED) infections. Compared with a single dose of cefazolin, the perioperative administration of cefazolin, vancomycin, bacitracin, and cephalexin did not significantly decrease the risk of infection. Our objective was to compare the microbiology of infections between study arms in PADIT., Methods: This was a post hoc analysis. Differences between study arms in the microbiology of infections were assessed at the level of individual patients and at the level of microorganisms using the Fisher exact test., Results: Overall, 209 microorganisms were reported from 177 patients. The most common microorganisms were coagulase-negative staphylococci (CoNS; 82/209 [39.2%]) and S. aureus (75/209 [35.9%]). There was a significantly lower proportion of CoNS in the incremental arm compared with the standard arm (30.1% vs 46.6%; P = .04). However, there was no significant difference between study arms in the frequency of recovery of other microorganisms. In terms of antimicrobial susceptibility, 26.5% of microorganisms were resistant to cefazolin. CoNS were more likely to be cefazolin-resistant in the incremental arm (52.2% vs 26.8%, respectively; P = .05). However, there was no difference between study arms in terms of infections in which the main pathogen was sensitive to cefazolin (77.8% vs 64.3%; P = .10) or vancomycin (90.8% vs 90.2%; P = .90)., Conclusions: Intensification of the prophylaxis led to significant changes in the microbiology of infections, despite the absence of a decrease in the overall risk of infections. These findings provide important insight on the physiopathology of CIED infections., Trial Registration: NCT01002911., (© The Author(s) 2021. Published by Oxford University Press on behalf of Infectious Diseases Society of America.)
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- 2021
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48. Implantable vs Prolonged External Electrocardiographic Monitoring for Atrial Fibrillation Detection in Patients With Ischemic Stroke-Reply.
- Author
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Buck BH, Hill MD, and Exner DV
- Subjects
- Humans, Atrial Fibrillation complications, Atrial Fibrillation diagnosis, Brain Ischemia diagnosis, Ischemic Attack, Transient, Ischemic Stroke, Stroke
- Published
- 2021
- Full Text
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49. Economic evaluation of extended electrocardiogram monitoring for atrial fibrillation in patients with cryptogenic stroke.
- Author
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Chew DS, Rennert-May E, Quinn FR, Buck B, Hill MD, Spackman E, Manns BJ, and Exner DV
- Subjects
- Cost-Benefit Analysis, Electrocardiography, Electrocardiography, Ambulatory, Humans, Atrial Fibrillation complications, Atrial Fibrillation diagnosis, Ischemic Stroke, Stroke complications, Stroke diagnosis
- Abstract
Background: Timely identification of occult atrial fibrillation following cryptogenic stroke facilitates consideration of oral anticoagulation therapy. Extended electrocardiography monitoring beyond 24 to 48 h Holter monitoring improves atrial fibrillation detection rates, yet uncertainty remains due to upfront costs and the projected long-term benefit. We sought to determine the cost-effectiveness of three electrocardiography monitoring strategies in detecting atrial fibrillation after cryptogenic stroke., Methods: A decision-analytic Markov model was used to project the costs and outcomes of three different electrocardiography monitoring strategies (i.e. 30-day electrocardiography monitoring, three-year implantable loop recorder monitoring, and conventional Holter monitoring) in acute stroke survivors without previously documented atrial fibrillation., Results: The lifetime discounted costs and quality-adjusted life years were $206,385 and 7.77 quality-adjusted life years for conventional monitoring, $207,080 and 7.79 quality-adjusted life years for 30-day extended electrocardiography monitoring, and $210,728 and 7.88 quality-adjusted life years for the implantable loop recorder strategy. Additional quality-adjusted life years could be attained at a more favorable incremental cost per quality-adjusted life year with the implantable loop recorder strategy, compared with the 30-day electrocardiography monitoring strategy, thereby eliminating the 30-day strategy by extended dominance. The implantable loop recorder strategy was associated with an incremental cost per quality-adjusted life year gained of $40,796 compared with conventional monitoring. One-way sensitivity analyses indicated that the model was most sensitive to the rate of recurrent ischemic stroke., Conclusions: An implantable loop recorder strategy for detection of occult atrial fibrillation in patients with cryptogenic stroke is more economically attractive than 30-day electrocardiography monitoring compared to conventional monitoring and is associated with a cost per quality-adjusted life year gained in the range of other publicly funded therapies. The value proposition is improved when considering patients at the highest risk of recurrent ischemic stroke. However, the implantable loop recorder strategy is associated with increased health care costs, and the opportunity cost of wide scale implementation must be considered.
- Published
- 2021
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50. Exploring the Refractory Period of an Active Stand in Females With Initial Orthostatic Hypotension.
- Author
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Sheikh NA, Ranada S, Kogut K, Bourne KM, Lei LY, Sheldon RS, Exner DV, Phillips AA, Runte M, and Raj SR
- Subjects
- Adult, Female, Hemodynamics, Humans, Hypotension, Orthostatic physiopathology
- Published
- 2021
- Full Text
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