Health Security Perceptions: Initial Psychometric Analysis of the Construct of Health Security in Chronic Illness Among Patients With a Cardiac Device.

Scale measuring the construct of "health security in chronic illness" (HSCI) was piloted in Canadian cardiac device patients (N = 176) enrolled in a remote-monitoring study at 2 timepoints. Analysis revealed a 2-factor solution, labeled as "support" and "certainty". Patients reported receiving less support over time, but consistent health certainty. Patients with implantable cardioverter defibrillators felt less secure over time and reported lower levels of health security in chronic illness than pacemaker patients.

Une échelle mesurant le concept de la « sécurité en matière de santé en présence d'une maladie chronique ¼ a fait l'objet d'un projet pilote auprès de patients canadiens porteurs de dispositifs cardiaques (N = 176) inscrits dans une étude de télésurveillance comportant deux évaluations. L'analyse a révélé une solution à deux facteurs, soit le soutien et la certitude. Les patients ont déclaré qu'ils recevaient moins de soutien au fil du temps, mais que la certitude quant à leur santé était constante. Les porteurs d'un défibrillateur cardioverteur implantable se sentaient moins en sécurité au fil du temps et signalaient de plus bas niveaux de sécurité en matière de santé, relativement à leur maladie chronique, que les porteurs d'un stimulateur cardiaque.

Progression of Atrial Fibrillation after Cryoablation or Drug Therapy.

BACKGROUND: Atrial fibrillation is a chronic, progressive disorder, and persistent forms of atrial fibrillation are associated with increased risks of thromboembolism and heart failure. Catheter ablation as initial therapy may modify the pathogenic mechanism of atrial fibrillation and alter progression to persistent atrial fibrillation. METHODS: We report the 3-year follow-up of patients with paroxysmal, untreated atrial fibrillation who were enrolled in a trial in which they had been randomly assigned to undergo initial rhythm-control therapy with cryoballoon ablation or to receive antiarrhythmic drug therapy. All the patients had implantable loop recorders placed at the time of trial entry, and evaluation was conducted by means of downloaded daily recordings and in-person visits every 6 months. Data regarding the first episode of persistent atrial fibrillation (lasting ≥7 days or lasting 48 hours to 7 days but requiring cardioversion for termination), recurrent atrial tachyarrhythmia (defined as atrial fibrillation, flutter, or tachycardia lasting ≥30 seconds), the burden of atrial fibrillation (percentage of time in atrial fibrillation), quality-of-life metrics, health care utilization, and safety were collected. RESULTS: A total of 303 patients were enrolled, with 154 patients assigned to undergo initial rhythm-control therapy with cryoballoon ablation and 149 assigned to receive antiarrhythmic drug therapy. Over 36 months of follow-up, 3 patients (1.9%) in the ablation group had an episode of persistent atrial fibrillation, as compared with 11 patients (7.4%) in the antiarrhythmic drug group (hazard ratio, 0.25; 95% confidence interval [CI], 0.09 to 0.70). Recurrent atrial tachyarrhythmia occurred in 87 patients in the ablation group (56.5%) and in 115 in the antiarrhythmic drug group (77.2%) (hazard ratio, 0.51; 95% CI, 0.38 to 0.67). The median percentage of time in atrial fibrillation was 0.00% (interquartile range, 0.00 to 0.12) in the ablation group and 0.24% (interquartile range, 0.01 to 0.94) in the antiarrhythmic drug group. At 3 years, 8 patients (5.2%) in the ablation group and 25 (16.8%) in the antiarrhythmic drug group had been hospitalized (relative risk, 0.31; 95% CI, 0.14 to 0.66). Serious adverse events occurred in 7 patients (4.5%) in the ablation group and in 15 (10.1%) in the antiarrhythmic drug group. CONCLUSIONS: Initial treatment of paroxysmal atrial fibrillation with catheter cryoballoon ablation was associated with a lower incidence of persistent atrial fibrillation or recurrent atrial tachyarrhythmia over 3 years of follow-up than initial use of antiarrhythmic drugs. (Funded by the Cardiac Arrhythmia Network of Canada and others; EARLY-AF ClinicalTrials.gov number, NCT02825979.).

Randomized trial of conventional versus radiofrequency needle transseptal puncture for cryoballoon ablation: the CRYO-LATS trial.

BACKGROUND: Transseptal puncture to achieve left atrial access is necessary for many cardiac procedures, including atrial fibrillation ablation. More recently, there has been an increasing need for left atrial access using large caliber sheaths, which increases risk of perforation associated with the initial advancement into the left atrium. We compared the effectiveness of a radiofrequency needle-based transseptal system versus conventional needle for transseptal access. METHODS: This prospective controlled trial randomized 161 patients with symptomatic paroxysmal atrial fibrillation undergoing cryoballoon pulmonary vein isolation to transseptal access with a commercially available transseptal system (radiofrequency needle plus stiff pigtail wire; RF + Pigtail group) versus conventional transseptal access (standard group). The primary outcome was time required for left atrial access. Secondary outcomes included failure of the assigned transseptal system, radiation exposure, and complications. RESULTS: The median transseptal puncture time was significantly shorter using the radiofrequency needle plus stiff pigtail wire transseptal system compared with conventional transseptal (840 ± 323 vs. 956 ± 407 s, P = 0.0489). Compared to conventional transseptal puncture, fewer transseptal attempts were required (1.0 ± 0.5 RF applications vs. 1.3 ± 0.8 mechanical punctures, P = 0.0123) and the fluoroscopy time was significantly shorter (72.0 [IQR 48.0, 129.0] vs. 93.0 [IQR 60.0, 171.0] s, P = 0.0490) with the radiofrequency needle plus stiff pigtail wire transseptal system. Failure to achieve transseptal LA access with the assigned system was rarely observed (1.3% vs. 5.7%, P = 0.2192). There were no procedural complications observed with either system. CONCLUSIONS: The use of a radiofrequency needle plus stiff pigtail wire resulted in shorter time to left atrial access and reduced fluoroscopy time compared to left atrial access using conventional transseptal equipment. TRIAL REGISTRATION: ClinicalTrials.gov identifier NCT03199703.

Remote Monitoring of Cardiovascular Implantable Electronic Devices in Canada: Survey of Patients and Device Health Care Professionals.

BACKGROUND: Remote monitoring is used to supplement in-clinic follow-up for patients with cardiac implantable electronic devices (CIEDs) every 6-12 months. There is a need to optimize remote management for CIEDs because of the consistent increases in CIED implants over the past decade. The objective of this study was to investigate real and perceived barriers to the use of remote patient management strategies in Canada and to better understand how remote models of care can be optimized. METHODS: We surveyed 512 CIED patients and practitioners in 22 device clinics in Canada. RESULTS: Device clinic surveys highlighted significant variation and inconsistency in follow-up care for in-clinic and remote visits across and within clinics. This survey showed that funding policies and management of additional workflow are barriers to optimal use and uptake. Despite this, device clinics perceive remote follow-up as a valuable resource and an efficient way to manage patient follow-up. Patients were broadly satisfied with their CIED follow-up care but identified barriers related to coordination of care, visit logistics, and information needs. Views varied as a function of clinical or sociodemographic characteristics. Most patients (n = 228; 91%) expressed a desire to receive a phone call from their device clinic after a remote transmission has been received. CONCLUSIONS: Lack of a unified, guideline-supported approach to follow-up after CIED implant, and discrepant funding policies across jurisdictions, are significant barriers to the use of remote patient management strategies in Canada. Efforts to increase or expand use of remote follow-up must recognize these barriers and the needs of specific subgroups of patients.

INTRODUCTION: La télésurveillance sert de complément à la consultation en clinique des patients porteurs d'un dispositif cardiaque électronique implantable (DCEI) tous les 6 à 12 mois. Il est nécessaire d'optimiser la prise en charge à distance des patients porteurs de DCEI en raison de la constante augmentation des implantations de DCEI au cours de la dernière décennie. L'objectif de la présente étude était d'examiner les obstacles réels et perçus à l'utilisation des stratégies de prise en charge à distance des patients du Canada et de mieux comprendre la façon d'optimiser les modèles de soins à distance. MÉTHODES: Nous avons interrogé 512 patients porteurs de DCEI et praticiens de 22 cliniques spécialisées en DCEI du Canada. RÉSULTATS: Les enquêtes des cliniques spécialisées en DCEI ont fait ressortir la variation importante et le manque d'uniformité dans les soins de suivi lors des consultations en clinique et à distance au sein de toutes les cliniques et entre elles. Cette enquête a montré que les politiques de financement et la gestion du flux de travail supplémentaire sont les obstacles qui empêchent l'utilisation optimale et l'adoption. Malgré cela, les cliniques spécialisées en DCEI perçoivent le suivi à distance comme une ressource très utile et un moyen efficace de prendre en charge le suivi du patient. Les patients étaient dans l'ensemble satisfaits de leurs soins de suivi relatifs à leur DCEI, mais relevaient des obstacles liés à la coordination des soins, à la logistique des consultations et à leurs besoins d'information. Les points de vue variaient en fonction des caractéristiques cliniques et sociodémographiques. La plupart des patients (n = 228 ; 91 %) ont fait part de leur souhait de recevoir un appel téléphonique de leur clinique spécialisée en DCEI après la réception de la transmission à distance. CONCLUSIONS: L'absence d'une approche unifiée et fondée sur les lignes directrices qui porte sur le suivi après l'implantation de DCEI, et la divergence des politiques de financement des provinces et territoires sont des obstacles importants à l'utilisation de stratégies de prise en charge à distance des patients au Canada. Les efforts visant à accroître ou à étendre l'utilisation du suivi à distance doivent tenir compte de ces obstacles et des besoins des sous-groupes particuliers de patients.

Remote-only monitoring for patients with cardiac implantable electronic devices: a before-and-after pilot study.

BACKGROUND: Outcomes for patients with cardiac implantable electronic devices are better when follow-up incorporates remote monitoring technology in addition to in-clinic visits. For patients with implantable devices, we sought to determine the feasibility, safety and associated health care utilization of remote-only follow-up, along with its effects on patients' quality of life and costs. METHODS: This multicentre before-and-after pilot study involved patients with new or existing pacemakers or implantable cardioverter defibrillators. The "before" phase of the study spanned the period October 2015 to February 2017; the "after" phase spanned the period October 2016 to February 2018. The exposure was remote-only follow-up in combination with Remote View, a service that facilitates access to device data, allowing device settings to be viewed remotely to facilitate remote programming. Outcomes at 12 months were feasibility (adherence to remote monitoring), safety (rate of adverse events) and health care utilization (remote and in-clinic appointments). We also assessed quality of life, using 3 validated scales, and costs, taking into account both health care system and patient costs. RESULTS: A total of 176 patients were enrolled. Adherence (defined as at least 1 successful remote transmission during follow-up) was 87% over a mean follow-up of 11.7 (standard deviation 2.2) months. There was a reduction in in-clinic visits at specialized sites among patients with both implantable defibrillators (26 v. 5, p < 0.001, n = 48) and pacemakers (42 v. 10, p < 0.001, n = 51). There was no significant change in visits to community sites for patients with defibrillators (13 v. 17, p = 0.3, n = 48). The composite rate of death, stroke, cardiovascular hospitalization and device-related hospitalization was 7% (n = 164). No adverse events were linked to the intervention. There was no change in quality-of-life scales between baseline and 12 months. Health care costs were reduced by 31% for patients with defibrillators and by 44% for those with pacemakers. INTERPRETATION: This pilot study showed the feasibility of remote-only follow-up, with no increase in adverse clinical outcomes and no effect on quality of life, but with reductions in costs and health care utilization. These results support progression to a larger-scale study of whether superior effectiveness and reduced cost can be achieved, with preservation of safety, through use of remote-only follow-up. TRIAL REGISTRATION: ClinicalTrials.gov, no. NCT02585817.

Cryoablation or Drug Therapy for Initial Treatment of Atrial Fibrillation.

BACKGROUND: Guidelines recommend a trial of one or more antiarrhythmic drugs before catheter ablation is considered in patients with atrial fibrillation. However, first-line ablation may be more effective in maintaining sinus rhythm. METHODS: We randomly assigned 303 patients with symptomatic, paroxysmal, untreated atrial fibrillation to undergo catheter ablation with a cryothermy balloon or to receive antiarrhythmic drug therapy for initial rhythm control. All the patients received an implantable cardiac monitoring device to detect atrial tachyarrhythmia. The follow-up period was 12 months. The primary end point was the first documented recurrence of any atrial tachyarrhythmia (atrial fibrillation, atrial flutter, or atrial tachycardia) between 91 and 365 days after catheter ablation or the initiation of an antiarrhythmic drug. The secondary end points included freedom from symptomatic arrhythmia, the atrial fibrillation burden, and quality of life. RESULTS: At 1 year, a recurrence of atrial tachyarrhythmia had occurred in 66 of 154 patients (42.9%) assigned to undergo ablation and in 101 of 149 patients (67.8%) assigned to receive antiarrhythmic drugs (hazard ratio, 0.48; 95% confidence interval [CI], 0.35 to 0.66; P<0.001). Symptomatic atrial tachyarrhythmia had recurred in 11.0% of the patients who underwent ablation and in 26.2% of those who received antiarrhythmic drugs (hazard ratio, 0.39; 95% CI, 0.22 to 0.68). The median percentage of time in atrial fibrillation was 0% (interquartile range, 0 to 0.08) with ablation and 0.13% (interquartile range, 0 to 1.60) with antiarrhythmic drugs. Serious adverse events occurred in 5 patients (3.2%) who underwent ablation and in 6 patients (4.0%) who received antiarrhythmic drugs. CONCLUSIONS: Among patients receiving initial treatment for symptomatic, paroxysmal atrial fibrillation, there was a significantly lower rate of atrial fibrillation recurrence with catheter cryoballoon ablation than with antiarrhythmic drug therapy, as assessed by continuous cardiac rhythm monitoring. (Funded by the Cardiac Arrhythmia Network of Canada and others; EARLY-AF ClinicalTrials.gov number, NCT02825979.).

A Randomized Trial of Video-based Education in Patients With Heart Failure: The Congestive Heart Failure Outreach Program of Education (COPE).

BACKGROUND: Heart failure (HF) exacerbations often relate to poor self-care. Education programs improve outcomes, but are resource-intensive. We developed a video-based educational intervention and evaluated it in patients with HF. METHODS: Congestive Heart Failure Outreach Program of Education was a pragmatic multicenter randomized trial. We included subjects with HF if they were hospitalized, seen in the emergency department (ED), or high-risk outpatients, and randomized them to intervention or control. Intervention included a 20-minute video, supplementary booklet, and 3 bimonthly newsletters focusing on salt and fluid restriction, daily weights, and medications. Subjects watched the video and were encouraged to review it at home, along with the booklet/newsletters. Control subjects received the booklet only. The primary outcome was the difference in cardiovascular hospitalizations or ED visits between groups at 6 months. Secondary outcomes included clinical events and in-hospital days. RESULTS: We recruited 539 subjects from 22 centers in Canada and the United States. Baseline characteristics were similar in both groups: 64% were male and had a mean age of 66 (± 13) years, mean ejection fraction 31% (± 13.5), and 65% New York Heart Association Functional Classification III/IV. The primary outcome occurred in 57 subjects (21%) in the intervention group compared with 61 subjects (23%) in the control group (P = 0.66). There were no significant differences in prespecified secondary outcomes; however, death occurred in 18 subjects (7%) in the intervention group and 33 subjects (12%) in the control group (P = 0.03). CONCLUSION: Video education on self-care did not reduce hospitalizations or ED visits in patients with HF. Of note, mortality was lower in the intervention group.

INTRODUCTION: L'exacerbation de l'insuffisance cardiaque (IC) est souvent liée à une mauvaise prise en charge autonome des soins. Les programmes d'enseignement améliorent les résultats cliniques, mais exigent beaucoup de ressources. Nous avons conçu une intervention éducative par vidéo et l'avons évaluée auprès de patients atteints d'IC. MÉTHODES: Le Congestive Heart Failure Outreach Program of Education était une étude pragmatique multicentrique à répartition aléatoire. Nous avons sélectionné les sujets atteints d'IC s'ils étaient hospitalisés, vus au service des urgences (SU) ou patients en consultation externe exposés à un risque élevé, et les avons répartis de manière aléatoire au groupe d'intervention ou au groupe témoin. L'intervention a consisté en une vidéo de 20 minutes, un livret supplémentaire et 3 bulletins bimensuels portant sur la restriction du sel et des liquides, les mesures quotidiennes du poids et les médicaments. Après que les sujets eurent regardé la vidéo, nous les avons encouragés à la revoir à la maison, en plus de lire le livret et les bulletins. Les sujets témoins ont reçu seulement le livret. Le critère de jugement principal était la différence dans les hospitalisations en raison d'une maladie cardiovasculaire ou les visites au SU entre les groupes après 6 mois. Les critères de jugement secondaires étaient les événements cliniques et les jours d'hospitalisation. RÉSULTATS: Nous avons recruté 539 sujets de 22 centres au Canada et aux États-Unis. Les caractéristiques initiales étaient similaires dans les 2 groupes : 64 % étaient des hommes et avaient un âge moyen de 66 ans (± 13), une fraction d'éjection moyenne de 31 % (± 13,5), et 65 % avaient une classification fonctionnelle III/IV de la New York Heart Association. Le critère de jugement principal est survenu chez 57 sujets (21 %) dans le groupe d'intervention et chez 61 sujets (23 %) dans le groupe témoin (P = 0,66). Il n'y a eu aucune différence significative dans les critères secondaires prédéfinis. Toutefois, 18 sujets (7 %) du groupe d'intervention et 33 sujets (12 %) du groupe témoin sont morts (P = 0,03). CONCLUSION: L'enseignement sur les autosoins par vidéo n'a pas réduit les hospitalisations ou les visites au SU des patients atteints d'IC. Notamment, la mortalité a été plus faible dans le groupe d'intervention.

A Population-Based Study of Device Eligibility, Use, and Reasons for Nonimplantation in Patients at Heart Function Clinics.

BACKGROUND: Implantable cardioverter defibrillator (ICD) therapy is lifesaving; however, real-world data regarding the proportion of patients eligible for a primary prevention ICD and subsequent use remain sparse. This study evaluated rates of primary prevention ICD eligibility and use among patients in heart function clinics (HFCs) and to identify reasons for nonimplantation. METHODS: A retrospective study was performed of patients seen at HFCs in Alberta, Canada, from 2013 to 2015. Demographics, comorbidities, clinical indications, and reasons for nonimplantation were abstracted. Eligibility was defined according to the 2008 American College of Cardiology/American Heart Association/Heart Rhythm Society ICD, 2012 American College of Cardiology/American Heart Association/Heart Rhythm Society Focused Update, and 2013 Canadian Cardiovascular Society Cardiac Resynchronization Therapy guidelines. Logistic regression was used to calculate an odds ratio (OR) and 95% confidence interval (CI) for predictors of nonimplantation. RESULTS: Among 1239 patients in HFCs, the median age was 70 years (interquartile range, 59-80), 67% were male, and the median left ventricular ejection fraction was 0.40 (interquartile range, 0.28-0.53). Overall, 45% of patients (n = 553) met guideline criteria for an ICD, and of those, 36% (n = 198) received a device. Among device nonrecipients, 52% (n = 185) had no documented reason for nonimplantation. The most common reason for nonimplantation among nonrecipients was patient preference (48%). Predictors associated with nonimplantation were age more than 75 years (OR, 1.92; 95% CI, 1.31-2.82) and history of cancer (OR, 2.26; 95% CI, 1.07-4.78). At 3 years follow-up, 27% of nonrecipients were deceased. CONCLUSIONS: We found that one-third of patients who met guideline criteria received an ICD and that documentation for nonimplantation was poor.

CONTEXTE: Le défibrillateur cardioverteur implantable (DCI) sauve des vies. Or, les données recueillies dans la pratique réelle concernant le pourcentage de patients admissibles à l'implantation d'un tel dispositif en prévention primaire et l'utilisation subséquente de ce dispositif sont très limitées. Cette étude a évalué le taux de patients admissibles à la pose d'un DCI en prévention primaire et le taux d'utilisation de ce dispositif chez des patients traités en clinique de cardiologie. Elle a également recensé les motifs de non-implantation. MÉTHODOLOGIE: Une étude rétrospective a été réalisée chez des patients traités de 2013 à 2015 dans plusieurs cliniques de cardiologie de l'Alberta, au Canada. Les données relatives aux caractéristiques démographiques, aux comorbidités, aux indications cliniques et aux motifs de la non-implantation ont été extraites. L'admissibilité était définie en fonction des lignes directrices de 2008 de l'American College of Cardiology, de l'American Heart Association et de la Heart Rhythm Society sur le DCI, de leur mise à jour ciblée en 2012 et des lignes directrices de 2013 de la Société canadienne de cardiologie sur la thérapie de resynchronisation cardiaque. Une régression logistique a été utilisée pour calculer le risque relatif approché (RRA) et l'intervalle de confiance (IC) à 95 % associés aux facteurs de prédiction de la non-implantation. RÉSULTATS: L'âge médian des 1 239 patients traités en clinique de cardiologie était de 70 ans (plage interquartile : 59 ­ 80 ans); 67 % d'entre eux étaient des hommes, et la fraction d'éjection ventriculaire gauche médiane était de 0,40 (plage interquartile : 0,28 ­ 0,53). D'une manière générale, 45 % des patients (n = 553) répondaient aux critères énoncés dans les lignes directrices pour la pose d'un DCI, et 36 % d'entre eux (n = 198) ont reçu un dispositif. Parmi les patients qui n'ont pas reçu de dispositif, aucun motif justifiant la non-implantation n'a été documenté chez 52 % des patients (n = 185); chez les 48 % des patients restants, le motif le plus courant pour justifier la non-implantation a été la préférence du patient. Les facteurs de prédiction associés à la non-implantation ont été l'âge (plus de 75 ans; RRA : 1,92; IC à 95 % : 1,31 ­ 2,82) et les antécédents de cancer (RRA : 2,26; IC à 95 % : 1,07 ­ 4,78). Après 3 ans de suivi, 27 % des patients qui n'avaient pas reçu de dispositif étaient décédés. CONCLUSIONS: Nous avons constaté que le tiers des patients qui répondaient aux critères énoncés dans les lignes directrices ont reçu un DCI et que les motifs justifiant la non-implantation étaient mal documentés.

A Population-Based Study of Adherence to Guideline Recommendations and Appropriate-Use Criteria for Implantable Cardioverter Defibrillators.

Studies evaluating physician adherence to guideline recommendations for implantable cardioverter defibrillator (ICD) therapy are sparse, and none exist for the application of appropriate-use criteria (AUC) in clinical practice. As part of a quality improvement initiative, a review of all ICD procedures was performed from January 1, 2015 to December 31, 2016 in Alberta, Canada, to evaluate the proportion of patients receiving appropriate ICD therapy and to identify reasons for nonadherence. Our device-implant process involves an electrophysiologist or implanting cardiologist evaluation, reminders of ICD eligibility criteria on the device requisition, and peer-review consensus. Implants were classified according to the 2008 American College of Cardiology/American Heart Association/Heart Rhythm Society (ACC/AHA/HRS) ICD guidelines, 2013 Canadian Cardiovascular Society (CCS) Cardiac Resynchronization Therapy (CRT) guidelines, and 2013 AUC. There were 1,300 ICD procedures performed, and the mean age was 63.8 ± 12.9 years; 79% were male; the mean ejection fraction was 0.32 ± 0.13, and 69% were for primary prevention. Among all implants, < 1% were discordant with American College of Cardiology/American Heart Association/Heart Rhythm Society (ACC/AHA/HRS) recommendations. Among CRT implants, 10% were inconsistent with Canadian Cardiovascular Society (CCS) recommendations. According to AUC, 92% of implants were appropriate. Reasons for nonadherence to ACC/AHA/HRS recommendations included QRS width < 120 msec (n = 3), LVEF > 0.35 (n = 2) and recent myocardial infarction (MI) (n = 1). The most common reason for nonadherence to AUC was the absence of criteria for classification (n = 57, 4%). In this population-based study, we found that a process of specialist evaluation, eligibility reminders on device forms, and peer-review consensus may improve adherence to guideline recommendations and AUC for ICD therapy.

Impact of Cardiac Resynchronization Therapy on Daily Physical Activity in Heart Failure Patients.

PURPOSE: Cardiac resynchronization therapy (CRT) has emerged as a beneficial therapy for heart failure (HF) patients. It has been shown to enhance cardiac pump function and increase exercise capacity in patients with HF who display wide QRS complex on their electrocardiogram. To date, few studies have assessed daily physical activity (PA) in CRT patients. The objective of this pilot study was to assess the impact of CRT on the physical function and daily PA of HF patients who met the standard indications for CRT implantation. METHODS: The daily PA of 18 CRT patients was measured using a SenseWear Armband for ∼3 d. Daily PA measurements included steps/d and time spent sedentary (≤1.5 metabolic equivalent tasks), in light PA (1.6-2.9 metabolic equivalent tasks), and in moderate-vigorous PA (≥3 metabolic equivalent tasks). To assess exercise capacity, a 6-min walk test was performed pre- and post-CRT. RESULTS: There was no significant change in the 6-min walk test distance from pre- to post-CRT (383 ± 99 m at baseline vs 402 ± 104 m post-CRT). There was a decrease in total steps/d from 3405 ± 2334 pre-CRT to 2553 ± 1692 post-CRT (P = .017). Furthermore, no significant changes were observed pre- to post-CRT with regard to the additional PA assessments. CONCLUSIONS: Our patients exhibited a sedentary lifestyle pre- and post-CRT. These findings underscore the need for a cardiac rehabilitation program that encourages post-CRT patients to decrease sedentary time.

Intracardiac ablation for atrioventricular nodal reentry tachycardia using a 6 mm distal electrode cryoablation catheter: Prospective, multicenter, North American study (ICY-AVNRT STUDY).

INTRODUCTION: Radiofrequency (RF) ablation is effective for slow pathway ablation, but carries a risk of inadvertent AV block requiring permanent pacing. By comparison, cryoablation with a 4-mm distal electrode catheter has not been reported to cause permanent AV block but has been shown to be less effective than RF ablation. We sought to define the safety and efficacy of a 6-mm distal electrode cryoablation catheter for slow pathway ablation in patients with atrioventricular nodal reentry tachycardia (AVNRT). METHODS AND RESULTS: Twenty-six U.S. and eight Canadian centers participated in the study. Patients with supraventricular tachycardia (SVT) thought likely to be AVNRT were enrolled. If AVNRT was inducible and confirmed to be the clinical SVT, then the slow pathway was targeted with a cryoablation catheter using a standardized protocol of best practices. Acute success was defined as inducibility of no more than one echo beat after cryoablation. Primary efficacy was defined as acute success and the absence of documented recurrent AVNRT over 6 months of follow-up. Primary safety was a composite of serious procedure-related adverse events and/or device-related complications. Note that 397 subjects met enrollment criteria after the EP study and received cryoablation. Mean ablation procedure duration (including a waiting period) was 89 ± 40 minutes, and mean fluoroscopy time was 4.8 ± 5.9 minutes. Isoproterenol was administered before cryoablation in 53% and after the last lesion in 85% of cases. Acute procedural success was realized in 95% (378 of 397) of subjects. No subject received a permanent pacemaker due to AV block. The slow pathway could not be ablated in 19 subjects, including: 12 due to inefficacy, 2 due to transient AV block, and 5 due to both inefficacy and transient AV block. RF ablation was used in the same procedure in 11 of 19 failed subjects, and was ineffective in 3 subjects. Among the group with acute success, 10 subjects (2.7%) had documented recurrent AVNRT over the 6-month follow-up period, and all occurred within 3 months of the index cryoablation. Serious procedure-related adverse events occurred in 4 subjects (1.0%), including one each: tamponade, pulmonary embolism, femoral vein hemorrhage, and diagnostic EP catheter knotting. None of these serious adverse events were related to use of the cryoablation catheter. Overall, 93% of subjects had successful slow pathway ablation at 6 months with the study cryoablation catheter. CONCLUSIONS: Cryoablation for AVNRT using a focal 6-mm catheter was safe and effective. It resulted in a low risk of recurrence over 6 months of follow-up with no incidence of AV block requiring permanent pacing.

Troubleshooting Cardiac Resynchronization Therapy in Nonresponders.

Heart failure (HF) is a critical health issue. Despite the advancements in pharmacotherapy, HF-related morbidity and mortality remains high. Cardiac resynchronization therapy (CRT) has been revolutionary in medically refractory, symptomatic HF patients with reduced ejection fraction and a prolonged, abnormal QRS complex. Although CRT affects electromechanical dys-synchrony resulting in favourable ventricular remodelling, improved functional capacity and clinical outcomes with fewer HF hospitalizations and better survival, the response to CRT is not uniform. A reported 20%-40% of patients, depending on the criteria used, are considered CRT nonresponders. Identifying a cause for nonresponse is challenging and often multifactorial and therefore requires a complete approach involving the entire patient journey. Effort to improve response includes careful consideration of selected patients, optimal therapy delivery, and comprehensive postimplantation care. Because of the prevalence of HF and generally poor prognosis, CRT provides an important treatment option, however, further research is needed to better understand reasons for CRT nonresponse and potential solutions.

Impact of Electrical Cardioversion on Quality of Life for the Treatment of Atrial Fibrillation.

BACKGROUND: Despite being a common intervention to restore sinus rhythm in patients with atrial fibrillation (AF), limited data exist on the impact of electrical cardioversion on quality of life (QoL) outcomes in clinical practice. METHODS: This was a prospective cohort study of consecutive patients with AF referred for outpatient electrical cardioversion at 2 hospitals in Edmonton from 2013-2014. Baseline demographics, clinical characteristics, medications, and procedure details were obtained. QoL was assessed at baseline and at 3 months using the global Short-Form Health Survey (SF-36) and the Atrial Fibrillation Effect on Quality of Life (AFEQT) questionnaire. RESULTS: One hundred patients underwent electrical cardioversion and completed follow-up. The median age was 62 years (interquartile range, 56-68 years) and 80% were men; the majority had nonparoxysmal AF (90%) with a mean left ventricular ejection fraction of 50.0% (± 12.4). At baseline, scores were lower than those reported from healthy individuals across all domains of the SF-36. The overall mean AFEQT score was 55.6 ± 24.4, and the domain-specific scores were as follows: symptoms, 66.2 ± 26.6; daily activities, 48.5 ± 29.5; treatment concerns, 57.6 ± 25.8; and treatment satisfaction, 56.7 ± 26.1. There were significant improvements in the vast majority of the SF-36 and AFEQT domains for the 51 patients who maintained sinus rhythm at 3 months. Patients who were in AF by 3 months demonstrated improvements in the AFEQT treatment concern score (P = 0.02) and SF-36 emotional role value (P < 0.01) compared with baseline values, which may be the result of treatment expectations related to cardioversion. CONCLUSIONS: There are significant QoL benefits for patients who maintain sinus rhythm after electrical cardioversion.

Oral Anticoagulation for Stroke Prevention in Canadian Practice: Stroke Prevention and Rhythm Interventions in Atrial Fibrillation (SPRINT-AF) Registry(.).

BACKGROUND: We explored patterns of and factors associated with the use of oral anticoagulation (OAC) for stroke prevention in patients with atrial fibrillation (AF) in contemporary Canadian practice. METHODS: Phase 1 of the Stroke Prevention and Rhythm Intervention in Atrial Fibrillation (SPRINT-AF) registry was a cross-sectional retrospective study of patients with nonvalvular AF (NVAF). From December 2012-July 2013, 936 consecutive patients with NVAF were enrolled in SPRINT-AF. Of the 782 patients treated with OAC, the proportion treated with warfarin and a new oral anticoagulant (NOAC) was 53.2% and 46.8%, respectively. The rate of OAC use was 90.9% among patients with a CHADS2 (Congestive Heart Failure, Hypertension, Age, Diabetes, Stroke/Transient Ischemic Attack) score ≥ 2. RESULTS: On multivariable analysis, the 2 strongest factors associated with NOAC use (compared with warfarin use) were an improved side effect profile (as perceived by the patient) and improved efficacy (as perceived by the physician) (odds ratio [OR], 0.10; 95% confidence interval [CI], 0.06-0.17; P < 0.01 and OR, 0.52; 95% CI, 0.36-0.76; P < 0.01, respectively). Lower cost was strongly associated with warfarin use (OR, 5.16; 95% CI, 3.49-7.63; P < 0.01). CONCLUSIONS: In this contemporary Canadian AF registry, the rate of guideline-concordant OAC use was high. About half of OAC-treated patients received NOACs. Patient- and physician-driven preferences, such as side effect profile, perceived greater efficacy, and cost, were strong determinants of NOAC use over warfarin use.

Esophageal perforation after radiofrequency ablation for atrial fibrillation.

A 69-year-old man underwent left atrial radiofrequency ablation for atrial fibrillation. After 10 minutes, the procedure was terminated due to pericardial tamponade secondary to perforation during mapping. Pericardiocentesis resolved the tamponade. Ablation was completed one week later, and the patient was discharged. Two days later, he presented with odynophagia. Computed tomography demonstrated small bilateral pleural effusions. He was judged to be stable and was discharged again, but returned 2 days later with chest pain. He was found to have esophageal perforation with empyema, which was repaired using a muscle patch and esophageal stenting, successfully treating the lesion with minimal morbidity.

Feasibility and safety of outpatient radiofrequency catheter ablation procedures for atrial fibrillation.

INTRODUCTION: Percutaneous catheter ablation for atrial fibrillation (AF) is a procedure performed typically in an inpatient setting. The feasibility and safety of catheter ablation in patients with paroxysmal and persistent AF were evaluated on an outpatient basis. METHODS: 230 AF ablation procedures were performed in 206 patients (74% male; mean age 56+/-9 years). Patients were admitted to the hospital outpatient facility in the morning for the AF ablation procedure on the same day. The ablation strategy consisted of wide area circumferential lines around both ipsilateral pulmonary veins. After monitoring in the outpatient service, patients were discharged on the same day, if they were clinically stable. RESULTS: Mean procedure time was 201+/-31 min. Major complications occurred in seven patients (3%). One patient (0.4%) suffered a minor stroke and six patients had pericardial tamponade requiring percutaneous drainage. Patients could be discharged on the same day following 205 (89%) procedures. Among the 148 patients whose clinical outcome was assessed at 6 months, 127 (86%) had a reduction of the total symptomatic AF episodes, compared to pre-ablation, with a complete lack of symptoms in 101 patients (68%). CONCLUSION: Catheter ablation of AF on the day of admission is feasible and safe with a low risk of complications. The vast majority of the patients can be discharged on the same day.

Ablation of atrial fibrillation after the retirement age: considerations on safety and outcome.

BACKGROUND: Although the incidence of atrial fibrillation (AF) progressively increases with age, the vast majority of AF ablation is done in middle-aged patients. We evaluated the feasibility and safety of catheter ablation in patients older than 65 years of age with paroxysmal and persistent AF. METHODS: Out of a total of 230 consecutive AF ablation procedures, 45 patients were older than 65 years of age and underwent 53 procedures. The ablation strategy consisted of wide-area circumferential lines around both ipsilateral pulmonary veins using a three-dimensional mapping system. RESULTS: The mean age was 69 ± 3.5 years (35 males). The mean duration for AF was 8.7 ± 6.5 years. Thirty-nine had paroxysmal and six persistent AF despite use of 1.38 ± 0.77 antiarrhythmic drugs. All patients had a structurally normal heart. Eleven had systemic hypertension. Mean procedure time was 187 ± 33 min. Acute procedural success rate with abolition of all pulmonary vein potentials was achieved in all patients. Pericardial tamponade requiring percutaneous drainage occurred in one (1.9%) patient. There were no cardioembolic events. Among the 43 patients whose clinical outcome was assessed at 6 months, 34 (79%) had a significant reduction (>90%) of the total symptomatic AF burden, compared to pre-ablation, with a complete lack of symptomatic AF in 32 (74%) patients. The success rate was higher for patients with paroxysmal versus persistent AF (81 vs. 67%). Six patients (11%) underwent repeat procedures. CONCLUSIONS: Catheter ablation is a safe and effective treatment for patients over the age of 65 years with symptomatic, drug-refractory AF. Therefore, patients should not be excluded from undergoing AF catheter ablation on the basis of age alone.

Catheter ablation of atrial fibrillation guided by complex fractionated atrial electrogram mapping of atrial fibrillation substrate.

Cardiologists and physicians have witnessed a significant change in the management of atrial fibrillation (AF): antiarrhythmic agents are no longer considered more effective than just merely using compounds that control ventricular response of the arrhythmia with anticoagulation in high-risk patients. Catheter ablation has grown into wider acceptance as an important therapeutic modality in treating tachyarrhythmias. And over the past decade, several studies have clearly established that catheter ablation of atrial fibrillation is safe and effective and is an important alternative therapeutic option to the pharmacological approach. In general, there are two approaches to AF ablation: The anatomical approach, the most popular one, relies on isolation of electrical connections of all four pulmonary veins to the left atrium with or without adjuvant ablations, i.e. additional linear ablations. The second approach is the electrogram-guided approach by mapping and targeting areas of complex fractionated atrial electrograms (CFAE) which is the main topic of this review. The myriad pathologies leading to and resulting from AF have led to many theories regarding how substrate should be defined and how to reconcile substrate ablation with trigger ablation. The identification of spatiotemporally stable areas of very low amplitude short cycle length CFAE in a sea of otherwise discrete normal amplitude and relatively longer cycle length electrograms led to ablate the CFAE as a marker of abnormal substrate. This pure substrate-based ablation strategy has resulted in remarkable success, including mortality benefit, even in high-risk patients with very long standing persistent AF. In this review, we discuss in detail the prevailing mechanisms underlying CFAE, how to map and ablate CFAE sites, correlation of CFAE areas to those of ganglionic plexi, clinical outcomes of the approach, and the role of CFAE in the hybrid approach of AF ablation using a combination of pulmonary vein isolation and targeting CFAE areas.

Cardiac injury after percutaneous catheter ablation for atrial fibrillation.

AIMS: Small elevations in troponin T levels have been shown with limited radiofrequency (RF) ablation procedures for supraventricular tachycardia, usually to levels below the threshold for ischaemia or infarction. Left atrial catheter ablation for atrial fibrillation (AF) requires far more RF energy, therefore could be expected to have greater elevation in troponin T. We determined troponin T levels before and after ablation in these patients to evaluate the amount of rise with this ablation. METHODS: All patients undergoing pulmonary vein isolation (PVI) from May 2004 to October 2004 had troponin T levels measured 4 h following completion of the procedure. The first 30 patients also had a troponin T level measured 1 h prior to PVI to establish a baseline reference. RESULTS: Sixty patients were studied, with 81.7% males and a mean age of 54.6 +/- 9.9 years. No patient had underlying structural heart disease. The baseline troponin T level was normal (<0.01 microg/L) in all 30 patients. Post-procedure troponin T levels were elevated in all 60 patients compared with baseline (P < 0.05), with a mean level of 0.85 microg/L and a range of 0.26-1.57 microg/L after an average RF ablation time of 56 +/- 15 min. All levels were above the reference range for diagnosis of acute myocardial infarction (>0.15 microg/L). Troponin T level was not related to the number of RF lesions, RF time, procedure time, or associated external cardioversion. CONCLUSIONS: Troponin T elevations occurred in all patients undergoing PVI, to levels at least 20 times the normal concentration, into the range for diagnosis of acute myocardial infarction. Therefore, troponin T would not be specific for ischaemia in the setting of chest pain post-catheter ablation for AF.

Does 24-hour ST-segment resolution postfibrinolysis add prognostic value to a Q wave? An ASSENT 2 electrocardiographic substudy.

BACKGROUND: Both ST resolution and Q-wave development postfibrinolysis provide important prognostic insights in patients with acute myocardial infarction (MI). However, the relative contributions of these 2 factors to risk assessment have not been examined prospectively. METHODS AND RESULTS: ST resolution and Q development were evaluated 24 to 36 hours (24-36 h) postfibrinolysis in ASSENT-2: 13,100 out of 16,949 patients who had both baseline and 24-36 h electrocardiograms free of confounders (left bundle branch block, ventricular rhythm, reinfarction before 24-36 h electrocardiograms) were included in this analysis. Q-wave MI evolved in 10,466 patients (79.9%) and 2634 patients (20.1%) had non-Q-wave MI at 24-36 h postfibrinolysis. Mortality rates at 1-year were 7.0% for patients with Q-wave MI and 5.8% for non-Q-wave MI patients, respectively (P =.046). Patients with Q-wave MI versus those without were less likely to have complete ST-segment resolution (49.1% vs 59.1%) and more likely to have partial (37.1% vs 27.8%) or no resolution (13.8% vs 13.1%) at 24 to 36 hours postfibrinolysis (P <.001). Mortality rates at 1 year for Q-wave MI with complete, partial, and no resolution were 5.2%, 8.1%, and 10.1%, respectively (P <.001), and for non-Q-wave MI with complete, partial, and no resolution were 4.5%, 7.6%, and 8.0% (P =.003). CONCLUSION: These results demonstrate the additional prognostic significance of ST-segment resolution to Q-wave development at 24 to 36 hours after fibrinolysis.