Quality of life improves in vasovagal syncope patients after clinical trial enrollment regardless of fainting in follow-up.

BACKGROUND: Frequent syncope is linked to poorer health-related quality of life (HRQoL). Recurrent syncope has been observed to reduce in all groups after seeing a syncope expert and enrolling in a clinical trial. It is unknown if HRQoL improves with this reduction in syncope recurrence. OBJECTIVES: We examined the change in HRQoL over time in vasovagal syncope (VVS) patients seen by a syncope expert and enrolled in a trial. We also explored whether change differed with treatment or the frequency of fainting during follow up. METHODS: The Short Form Health Survey (SF36) was completed at baseline (BL), 6 m, and 12 m post-enrollment by VVS patients in the 1st and 2nd Prevention of Syncope Trials, which were multi-centered, randomized, placebo-controlled trials of metoprolol (POST) and fludrocortisone (POST2). Differences in HRQoL at BL, 6 m, and 12 m were analyzed and compared by faints in follow-up and randomization group. RESULTS: Complete study data were available for 143 VVS patients (40 ±â€¯17 years, 62% F). Over 12 months, patients reported improvement in all SF36 dimensions except for bodily pain. Post hoc analyses indicated that differences first occurred between BL and 6 m for all but general health. Fainting in follow-up or drug randomization group did not diminish the improvements. The baseline syncope burden was not different whether patients' HRQoL improved or not. CONCLUSION: HRQoL of VVS patients improves over time after enrolling in a clinical trial, even with recurrent faints or randomization to placebo. Improvements may result from alternative factors, such as interaction with experts or patient adjustment.

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.

Phenotypic analysis of arrhythmogenic cardiomyopathy in the Hutterite population: role of electrocardiogram in identifying high-risk desmocollin-2 carriers.

BACKGROUND: The p.Gln554X mutation in desmocollin-2 (DSC2) is prevalent in ≈10% of the Hutterite population. While the homozygous mutation causes severe biventricular arrhythmogenic right ventricular cardiomyopathy, the phenotypic features and prognosis of heterozygotes remain incompletely understood. METHODS AND RESULTS: Eleven homozygotes (mean age 32±8 years, 45% female), 28 heterozygotes (mean age 40±15 years, 50% female), and 22 mutation-negatives (mean age 43±17 years, 41% female) were examined. Diagnostic testing was performed as per the arrhythmogenic right ventricular cardiomyopathy modified Task Force Criteria. Inverted T waves in the right precordial leads on ECG were seen in all homozygotes but not in their counterparts (P<0.001). Homozygotes had higher median daily premature ventricular complex burden than did heterozygotes or mutation-negatives (1407 [IQR 1080 to 2936] versus 2 [IQR 0 to 6] versus 6 [IQR 0 to 214], P=0.0002). Ventricular tachycardia was observed in 60% of homozygotes but in none of the remaining individuals (P<0.001). On cardiac magnetic resonance imaging, homozygotes had significantly larger indexed end-diastolic volumes (right ventricular: 122±24 versus 83±17 versus 83±12 mL/m(2), P<0.0001; left ventricular: 93±18 versus 76±13 versus 80±11 mL/m(2), P=0.0124) and lower ejection fraction values compared with heterozygotes and mutation-negatives (right ventricular ejection fraction: 41±9% versus 59±9% versus 61±6%, P<0.0001; left ventricular ejection fraction: 53±8% versus 65±5% versus 64±5%, P<0.0001). Most affected individuals lacked right ventricular wall motion abnormalities. Thus, few met cardiac magnetic resonance imaging task force criteria. CONCLUSIONS: The ECG reliably identifies homozygous p.Gln554X carriers and may be useful as an initial step in the screening of high-risk Hutterites. The cardiac phenotype of heterozygotes appears benign, but further prospective follow-up of their arrhythmic risk is needed.

Getting by with less - the "frugal tie".

The ability to tie surgical knots efficiently and effectively is an essential surgical skill for medical procedures, especially pacemaker implantation. Device generators and their leads need to be safely anchored with sutures during implantation to prevent dislodgement and inadequate packaging in the pacemaker pocket. With most knot tying techniques, a generous amount of suture slack is required. We introduce a new technique that is a variation of the 2-handed surgical square knot and the 1-handed surgeon's knot that allows one to finish or tie a knot when left with little slack.

Canadian Cardiovascular Society guidelines on the use of cardiac resynchronization therapy: implementation.

Recent studies have provided the impetus to update the recommendations for cardiac resynchronization therapy (CRT). This article provides guidance on the implementation of CRT and is intended to serve as a framework for the implementation of CRT within the Canadian health care system and beyond. These guidelines were developed through a critical evaluation of the existing literature, and expert consensus. The panel unanimously adopted each recommendation. The 9 recommendations relate to patient selection in the presence of comorbidities, delivery and optimization of CRT, and resources required to deliver this therapy. The strength of evidence was weighed, taking full consideration of any risk of bias, and any imprecision, inconsistency, and indirectness of the available data. The strength of each recommendation and the quality of evidence were adjudicated. Trade-offs between desirable and undesirable consequences of alternative management strategies were considered, as were values, preferences, and resource availability. These guidelines were externally reviewed by experts, modified based on those reviews, and will be updated as new knowledge is acquired.

Clinical predictors of Fidelis lead failure: report from the Canadian Heart Rhythm Society Device Committee.

BACKGROUND: Approximately 268,000 Fidelis leads were implanted worldwide until distribution was suspended because of a high rate of early failure. Careful analyses of predictors of increased lead failure hazard are required to help direct future lead design and also to inform decision making on lead replacement. We sought to perform a comprehensive analysis of all potential predictors in a multicenter study. METHODS AND RESULTS: A total of 3169 Sprint Fidelis leads were implanted in 11 centers with a total of 251 failures. Lead failure rates at 3, 4, and 5 years were 5.3%, 10.6%, and 16.8%, respectively. The rate of lead failure continues to accelerate (P<0.001). There were 4 independent predictors of failure: center, sex, access vein, and previous lead failure. Women had a higher hazard of failure (hazard ratio 1.51; 95% confidence interval, 1.14-2.04; P=0.005). Both axillary and subclavian access increased the hazard of failure (P=0.007); hazard ratio for axillary was 1.94, (95% confidence interval, 1.23-3.04) and for subclavian 1.63 (95% confidence interval, 1.08-2.46). Previous lead failure increased the hazard of a subsequent Fidelis failure with a hazard ratio of 3.12 (95% confidence interval, 1.80-5.41; P<0.001). CONCLUSIONS: The rate of Fidelis failure continues to increase over time, with failures approaching 17% at 5 years. Women, patients with leads inserted via the subclavian or axillary vein, and those with a previous lead fracture were at greatest risk of Fidelis failure. Our data suggest that Fidelis replacement should be strongly considered at the time of generator replacement.

Cigarette smoking, stages of change, and major depression in the Canadian population.

OBJECTIVE: To describe the 12-month prevalence of major depression in relation to smoking status, nicotine dependence levels, commitment to quit, attempts to quit, and maintenance of smoking cessation in the Canadian general population. METHOD: Data from Public Use Microdata File of the Canadian Community Health Survey: Health and Well-Being were used. The Composite International Diagnostic Interview--Short Form (CIDI-SF) for major depression was used to assess depressive disorder status. The survey also included a smoking module. There were 49,249 respondents assessed by the CIDI-SF, of whom 10,236 were administered the smoking module. Analyses used appropriate measures to deal with survey design effects. RESULT: The prevalence of major depression was highest in current smokers, followed by ever smokers, former smokers, and was lowest in the never smokers. This pattern persisted after stratification for age and sex. For quitting, the prevalence of major depression was highest among people who tried to quit, followed by those who considered quitting, those who quit in the past year, and lowest among those who maintained their smoking cessation status for longer than 1 year. The prevalence of depression among those with a high nicotine dependence level, as assessed by the Fagerstrom Tolerance Questionnaire, was about twice that of people with a low nicotine dependence level. CONCLUSION: The strikingly high prevalence of major depression among current smokers who are young, trying to quit, and with high nicotine dependence levels in the general population indicates that further longitudinal exploration of this topic is urgently needed.

Prophylactic amiodarone for prevention of atrial fibrillation after cardiac surgery: a meta-analysis.

Amiodarone has been proposed to decrease atrial fibrillation after cardiac surgery. The literature was systematically reviewed for randomized trials comparing amiodarone with control for prevention of atrial fibrillation. Data were extracted on study characteristics, quality, and incidence of atrial fibrillation, cardiovascular outcomes, and length of hospitalization. Nineteen trials were included. Amiodarone reduced the odds ratio of atrial fibrillation (0.50; 95% confidence interval [CI]: 0.43 to 0.59, p < 0.0001), ventricular tachyarrhythmias (0.39; 95% CI: 0.26 to 0.58, p < 0.0001), and strokes (0.53; 95% CI: 0.30 to 0.92, p = 0.02). Amiodarone reduced hospital stay (0.6 days; 95% CI: 0.4 to 0.8, p < 0.0001). Amiodarone decreased atrial fibrillation, reduced perioperative ventricular tachyarrhythmias and strokes, and reduced duration of hospitalization. The current evidence supports recommending the routine use of perioperative amiodarone for cardiac surgery.

Prophylactic Oral Amiodarone for the Prevention of Arrhythmias that Begin Early After Revascularization, Valve Replacement, or Repair: PAPABEAR: a randomized controlled trial.

CONTEXT: Atrial tachyarrhythmias after cardiac surgery are associated with adverse outcomes and increased costs. Previous trials of amiodarone prophylaxis, while promising, were relatively small and yielded conflicting results. OBJECTIVE: To determine whether a brief perioperative course of oral amiodarone is an effective and safe prophylaxis for atrial tachyarrhythmias after cardiac surgery overall and in important subgroups. DESIGN, SETTING, AND PATIENTS: Double-blind randomized controlled trial of 601 patients listed for nonemergent coronary artery bypass graft (CABG) surgery and/or valve replacement/repair surgery between February 1, 1999, and September 26, 2003, at a tertiary care hospital. The patients were followed up for 1 year. INTERVENTION: Oral amiodarone (10 mg/kg daily) or placebo administered 6 days prior to surgery through 6 days after surgery (13 days). Randomization was stratified for subgroups defined by age, type of surgery, and use of preoperative beta-blockers. MAIN OUTCOME MEASURE: Incidence of atrial tachyarrhythmias lasting 5 minutes or longer that prompted therapy by the sixth postoperative day. RESULTS: Atrial tachyarrhythmias occurred in fewer amiodarone patients (48/299; 16.1%) than in placebo patients (89/302; 29.5%) overall (hazard ratio [HR], 0.52; 95% confidence interval [CI], 0.34-0.69; P<.001); in patients younger than 65 years (19 [11.2%] vs 36 [21.1%]; HR, 0.51 [95% CI, 0.28-0.94]; P = .02); in patients aged 65 years or older (28 [21.7%] vs 54 [41.2%]; HR, 0.45 [95% CI, 0.27-0.75]; P<.001); in patients who had CABG surgery only (22 [11.3%] vs 46 [23.6%]; HR, 0.45 [95% CI, 0.26-0.79]; P = .002); in patients who had valve replacement/repair surgery with or without CABG surgery (25 [23.8%] vs 44 [44.1%]; HR, 0.51 [95% CI, 0.31-0.84; P = .008); in patients who received preoperative beta-blocker therapy (27 [15.3%] vs 42 [25.0%]; HR, 0.58 [95% CI, 0.34-0.99]; P = .03); and in patients who did not receive preoperative beta-blocker therapy (20 [16.3%] vs 48 [35.8%]; HR, 0.40 [95% CI, 0.22-0.71]; P<.001), respectively. Postoperative sustained ventricular tachyarrhythmias occurred less frequently in amiodarone patients (1/299; 0.3%) than in placebo patients (8/302; 2.6%) (P = .04). Dosage reductions of blinded therapy were more common in amiodarone patients (34/299; 11.4%) than in placebo patients (16/302; 5.3%) (P = .008). There were no differences in serious postoperative complications, in-hospital mortality, or readmission to the hospital within 6 months of discharge or in 1-year mortality. CONCLUSION: Oral amiodarone prophylaxis of atrial tachyarrhythmias after cardiac surgery is effective and may be safe overall and in important patient subgroups. Clinical Trials Registration ClinicalTrials.gov Identifier: NCT00251706.