Effect of e-Cigarettes Plus Counseling vs Counseling Alone on Smoking Cessation: A Randomized Clinical Trial.

Importance: Electronic cigarettes (e-cigarettes) for smoking cessation remain controversial. Objective: To evaluate e-cigarettes with individual counseling for smoking cessation. Design, Setting, and Participants: A randomized clinical trial enrolled adults motivated to quit smoking from November 2016 to September 2019 at 17 Canadian sites (801 individuals screened; 274 ineligible and 151 declined). Manufacturing delays resulted in early termination (376/486 participants, 77% of target). Outcomes through 24 weeks (March 2020) are reported. Interventions: Randomization to nicotine e-cigarettes (n = 128), nonnicotine e-cigarettes (n = 127), or no e-cigarettes (n = 121) for 12 weeks. All groups received individual counseling. Main Outcomes and Measures: The primary end point was point prevalence abstinence (7-day recall, biochemically validated using expired carbon monoxide) at 12 weeks, changed from 52 weeks following early termination. Participants missing data were assumed to be smoking. The 7 secondary end points, examined at multiple follow-ups, were point prevalence abstinence at other follow-ups, continuous abstinence, daily cigarette consumption change, serious adverse events, adverse events, dropouts due to adverse effects, and treatment adherence. Results: Among 376 randomized participants (mean age, 52 years; 178 women [47%]), 299 (80%) and 278 (74%) self-reported smoking status at 12 and 24 weeks, respectively. Point prevalence abstinence was significantly greater for nicotine e-cigarettes plus counseling vs counseling alone at 12 weeks (21.9% vs 9.1%; risk difference [RD], 12.8 [95% CI, 4.0 to 21.6]) but not 24 weeks (17.2% vs 9.9%; RD, 7.3 [95% CI, -1.2 to 15.7]). Point prevalence abstinence for nonnicotine e-cigarettes plus counseling was not significantly different from counseling alone at 12 weeks (17.3% vs 9.1%; RD, 8.2 [95% CI, -0.1 to 16.6]), but was significantly greater at 24 weeks (20.5% vs 9.9%; RD, 10.6 [95% CI, 1.8 to 19.4]). Adverse events were common (nicotine e-cigarette with counseling: 120 [94%]; nonnicotine e-cigarette with counseling: 118 [93%]; counseling only: 88 [73%]), with the most common being cough (64%) and dry mouth (53%). Conclusions and Relevance: Among adults motivated to quit smoking, nicotine e-cigarettes plus counseling vs counseling alone significantly increased point prevalence abstinence at 12 weeks. However, the difference was no longer significant at 24 weeks, and trial interpretation is limited by early termination and inconsistent findings for nicotine and nonnicotine e-cigarettes, suggesting further research is needed. Trial Registration: ClinicalTrials.gov Identifier: NCT02417467.

Impact of an invasive strategy in the elderly hospitalized with acute coronary syndrome with emphasis on the nonagenarians.

BACKGROUND: Published data about nonagenarians with acute coronary syndrome (ACS) were mainly descriptive and limited by small sample sizes and unadjusted outcomes. We aim to describe the characteristics, management, and the impact of an invasive strategy on major adverse events in elderly patients hospitalized with ACS with focus on the nonagerians. METHODS AND RESULTS: We analyzed data collected as part of the AMI-OPTIMA study, a cluster-randomized study of knowledge translation intervention versus usual care on optimal discharge medications in patients admitted with ACS at 24 Canadian hospitals. To determine whether an invasive strategy improved outcomes in the elderly, we used inverse probability weighting to adjust for confounders between patients who underwent invasive versus conservative strategies. Of 4,569 consecutive patients: 2,395 (52%) were <70 years old, 1,031 (23%) were septuagenarians, 941 (21%) were octogenarians, and 202 (4.4%) were nonagenarians. An invasive strategy was associated with reduced in-hospital all-cause mortality in all age groups: 1.1% versus 3.8% in patients <70 years old (P < 0.001), 2.9% versus 7.4% in septuagenarians (P < 0.001), 5.1% versus 14.7% in octogenarians (P < 0.001), and 12.0% versus 25.1% in nonagenarians (P = 0.001). An invasive strategy was also associated with higher thrombolysis in myocardial infarction major bleeds in the nonagenarians (9.0% vs. 2.0%; P = 0.003). CONCLUSIONS: The reduction in in-hospital mortality associated with an invasive strategy in elderly and nonagenarians presented with ACS is generating hypothesis and merits further studies to confirm these benefits and to guide clinicians in the management of these high-risk patients.

N-terminal pro-brain natriuretic peptide in acute Kawasaki disease correlates with coronary artery involvement.

BACKGROUND: We have lately documented the importance of N-terminal pro-brain natriuretic peptide in aiding the diagnosis of Kawasaki disease. OBJECTIVES: We sought to investigate the potential value of N-terminal pro-brain natriuretic peptide pertaining to the prediction of coronary artery dilatation (Z-score>2.5) and/or of resistance to intravenous immunoglobulin therapy. We hypothesised that increased serum N-terminal pro-brain natriuretic peptide level correlates with increased coronary artery dilatation and/or resistance to intravenous immunoglobulin. METHODS: We carried out a prospective study involving newly diagnosed patients treated with 2 g/kg intravenous immunoglobulin within 5-10 days of onset of fever. Echocardiography was performed in all patients at onset, then weekly for 3 weeks, then at month 2, and month 3. Coronary arteries were measured at each visit, and coronary artery Z-score was calculated. All the patients had N-terminal pro-brain natriuretic peptide serum level measured at onset, and the Z-score calculated. RESULTS: There were 109 patients enrolled at 6.58±2.82 days of fever, age 3.79±2.92 years. High N-terminal pro-brain natriuretic peptide level was associated with coronary artery dilatation at onset in 22.2 versus 5.6% for normal N-terminal pro-brain natriuretic peptide levels (odds ratio 4.8 [95% confidence interval 1.05-22.4]; p=0.031). This was predictive of cumulative coronary artery dilatation for the first 3 months (p=0.04-0.02), but not during convalescence at 2-3 months (odds ratio 1.28 [95% confidence interval 0.23-7.3]; p=non-significant). Elevated N-terminal pro-brain natriuretic peptide levels did not predict intravenous immunoglobulin resistance, 15.3 versus 13.5% (p=1). CONCLUSION: Elevated N-terminal pro-brain natriuretic peptide level correlates with acute coronary artery dilatation in treated Kawasaki disease, but not with intravenous immunoglobulin resistance.

Access to heart failure care post emergency department visit: do we meet established benchmarks and does it matter?

BACKGROUND: The Canadian Cardiology Society recommends that patients should be seen within 2 weeks after an emergency department (ED) visit for heart failure (HF). We sought to investigate whether patients who had an ED visit for HF subsequently consult a physician within the current established benchmark, to explore factors related to physician consultation, and to examine whether delay in consultation is associated with adverse events (AEs) (death, hospitalization, or repeat ED visit). METHODS: Patients were recruited by nurses at 8 hospital EDs in Québec, Canada, and interviewed by telephone within 6 weeks of discharge and subsequently at 3 and 6 months. Clinical variables were extracted from medical charts by nurses. We used Cox regression in the analysis. RESULTS: We enrolled 410 patients (mean age 74.9 ± 11.1 years, 53% males) with a confirmed primary diagnosis of HF. Only 30% consulted with a physician within 2 weeks post-ED visit. By 4 weeks, 51% consulted a physician. Over the 6-month follow-up, 26% returned to the ED, 25% were hospitalized, and 9% died. Patients who were followed up within 4 weeks were more likely to be older and have higher education and a worse quality of life. Patients who consulted a physician within 4 weeks of ED discharge had a lower risk of AEs (hazard ratio 0.59, 95% CI 0.35-0.99). CONCLUSION: Prompt follow-up post-ED visit for HF is associated with lower risk for major AEs. Therefore, adherence to current HF guideline benchmarks for timely follow-up post-ED visit is crucial.

Racial Disparities in Acute Coronary Syndrome Management Within a Universal Healthcare Context: Insights From the AMI-OPTIMA Trial.

BACKGROUND: Although prior studies have demonstrated racial disparities regarding acute coronary syndrome (ACS) care within private or mixed healthcare systems, few researchers have explored such disparities within universal healthcare systems. We aimed to evaluate the quality and outcomes of in-hospital ACS management for White patients vs patients of colour, within a universal healthcare context. METHODS: We performed a post hoc analysis of the Acute Myocardial Infarction - Knowledge Translation to Optimize Adherence to Evidence-Based Therapy study, a cluster-randomized trial evaluating a knowledge-translation intervention at 24 hospitals in Quebec, Canada (years: 2009 and 2012). The primary endpoint was coronary catheterization. The secondary endpoints included in-hospital mortality, percutaneous and surgical coronary revascularization, major bleeding, total stroke, and discharge prescription of evidence-based medical therapy. RESULTS: Of 3444 included patients, 2738 were White, and 706 were people of colour. The mean age was 68.2 years (33.3% women) among White patients and 69.5 years (36.0% women) among patients of colour. Patients of colour were less likely to undergo in-hospital coronary catheterization than were White patients (74.5% vs 80.3%, P = 0.001). This difference was attenuated after adjusting for patient-level characteristics (odds ratio 0.89; 95% confidence interval 0.73-1.09), and it was eliminated after adjusting for hospital-level characteristics (odds ratio 1.04; 95% confidence interval 0.73-1.49). CONCLUSIONS: Racial disparity in coronary catheterization for ACS persists within a universal healthcare context. Patients' comorbidities and hospital-level factors may be partially responsible for this inequality. Future research on cardiovascular healthcare in patients with diverse racial/ethnic backgrounds in universal healthcare systems is needed to remediate racial inequality in ACS management.

CONTEXTE: Bien que des études antérieures aient démontré l'existence de disparités raciales dans la prise en charge du syndrome coronarien aigu (SCA) au sein de systèmes de santé privés ou mixtes, peu de chercheurs ont étudié ces disparités au sein de systèmes universels de soins de santé. Nous avons cherché à évaluer la qualité et les résultats de la prise en charge du SCA à l'hôpital pour les patients blancs par rapport aux patients de couleur, dans un contexte de soins de santé universels. MÉTHODOLOGIE: Nous avons effectué une analyse a posteriori de l'étude AMI-OPTIMA, un essai sur échantillon en grappes aléatoire évaluant une intervention d'application des connaissances dans 24 hôpitaux du Québec, au Canada (années : 2009 et 2012). Le paramètre d'évaluation principal était le cathétérisme coronaire. Les paramètres d'évaluation secondaires comprenaient la mortalité à l'hôpital, la revascularisation coronaire percutanée et chirurgicale, l'hémorragie majeure, l'accident vasculaire cérébral et la prescription au congé d'un traitement médical fondé sur des données probantes. RÉSULTATS: Sur les 3444 patients étudiés, 2738 étaient blancs et 706 étaient des personnes de couleur. L'âge moyen était de 68,2 ans (33,3 % de femmes) chez les patients blancs, et de 69,5 ans (36,0 % de femmes) chez les patients de couleur. Les patients de couleur étaient moins susceptibles de subir un cathétérisme coronaire à l'hôpital que les patients blancs (74,5 % contre 80,3 %, p = 0,001). Cette différence a été atténuée après ajustement pour tenir compte des caractéristiques des patients (rapport de cotes : 0,89; intervalle de confiance [IC] à 95 % : 0,73-1,09), et éliminée après ajustement pour tenir compte des caractéristiques des hôpitaux (rapport de cotes : 1,04; IC à 95 % : 0,73-1,49). CONCLUSIONS: La disparité raciale en ce qui a trait au cathétérisme coronaire pour un SCA persiste dans un contexte de soins de santé universels. Les comorbidités des patients et des facteurs liés à l'hôpital peuvent être partiellement responsables de cette inégalité. De plus amples recherches sur les soins cardiovasculaires chez les patients de diverses origines raciales ou ethniques dans les systèmes universels de soins de santé sont nécessaires pour remédier aux inégalités raciales dans la prise en charge du SCA.

Primary care practices and determinants of optimal anticoagulation management in a collaborative care model.

BACKGROUND: In a collaborative care model (CCM) for managing oral anticoagulant therapy, patients are followed at a pharmacist-managed anticoagulation service and, once stabilized, are transferred to their primary care physician. The objective of this study was to describe physicians' clinical practices and the practice characteristics associated with better international normalized ratio (INR) control in a CCM. METHODS: A telephone questionnaire about their practices was administered to 121 physicians exposed to a CCM. The physicians followed 121 patients for a mean of 14.5 weeks. The percentage of time within the exact INR target range was computed and dichotomized (> or = or < median time within target range). Determinants of better INR control were identified using logistic regression models. RESULTS: The survey revealed that, after discharge from the pharmacist-managed anticoagulation service, patients are followed mainly by physicians and their secretaries. Physicians do not often consult other health professionals. Few report using technological resources to obtain INR results (39.7%), document medical follow-up (6.6%), or detect drug (32.2%) and food (9.9%) interactions. The median percentage of time within the exact INR target range was 84%. Determinants of better INR control include using computerized support to monitor patients (odds ratio [OR] 9.16, 95% CI 1.77-47.4) and detect drug interactions (OR 3.49, 95% CI 1.71-7.10) and consulting specialists (OR 5.92, 95% CI 1.49-32.48). CONCLUSIONS: Primary care physicians are poorly supported by technological and human resources to monitor patients on oral anticoagulant. Even in a CCM, interprofessional collaboration and better technological support may be associated with optimal INR control.

Natriuretic peptide as an adjunctive diagnostic test in the acute phase of Kawasaki disease.

Coronary arteritis rather than myocardial involvement is typically emphasized in Kawasaki disease (KD). Moreover, the criteria and the usual biological markers oversee the importance of cardiac-specific markers in diagnosing this disease. We sought to study the clinical usefulness of measuring B-type natriuretic peptide (BNP) and its N-terminal moiety (NT-proBNP) at the onset of KD. Our objective was to evaluate blood concentrations of BNP and NT-proBNP during the acute and subacute phases of KD. We conducted a prospective study comparing newly diagnosed KD patients to non-KD febrile controls. Blood specimens were collected at presentation, 6-12 h after intravenous immunoglobulin (IVIG) therapy, 1-2 weeks later, and 2-3 months later, or only upon reenrollment for controls. Forty-there KD and 19 control patients were enrolled consecutively. The mean age was 47.1 +/- 34.3 and 62.2 +/- 44.9 months, respectively (p = NS). Pre-IVIG NT-proBNP levels were significantly higher in KD patients than in controls (923.6 +/- 1361.7 vs. 186.2 +/- 198.0 ng/L; p < 0.001), with no statistical difference for BNP (141.9 +/- 227.5 vs. 59.9 +/- 72.4 ng/L; p = 0.112). In conclusion, our data indicate that NT-proBNP is a better marker of myocardial involvement in acute KD than BNP, particularly in cases with incomplete diagnostic criteria, and suggest that it may be a valid adjunctive diagnostic method to support the diagnosis of KD.

Is long-term pharmacist-managed anticoagulation service efficient? A pragmatic randomized controlled trial.

BACKGROUND: Some pharmacist-managed anticoagulation services (PMAS) provide initial follow-up to patients on oral anticoagulant, who are transferred to their physician once they are stabilized. This may be as effective as and less expensive than long-term PMAS follow-up. METHODS: Once PMAS patients were stabilized and ready for discharge, they were randomized to be transferred to their physician or stay with the PMAS. Quality of international normalized ratio (INR) control, incidence of complications, health-related quality of life, use of health care services, and direct incremental cost of PMAS follow-up were evaluated. RESULTS: One hundred thirty-eight physicians and 250 patients participated. Patients were initially followed at the PMAS for a mean of 11.3 weeks and afterwards were followed by their physician (n = 122) or by the PMAS pharmacists (n = 128) for a mean of 14.9 and 14.5 weeks, respectively. Pharmacist-managed anticoagulation services' and physician's patients were within the exact target range 77.3% and 76.7% of the time (95% CI of the difference -4.9% to 6.0%) and within the extended range 93.0% and 91.6% of the time (95% CI -2.1% to 4.7%), respectively. Pharmacist-managed anticoagulation services patients have seen their family physician less often (95% CI -3.1 to -0.1 visit per year). Number of INR tests, incidence of complications, and health-related quality of life were similar in both groups. The incremental cost of PMAS follow-up was estimated at CAN$123.80 per patient year. CONCLUSION: Once PMAS patients are well stabilized, maintaining a PMAS follow-up or transferring them to their physician is associated with excellent INR control. However, long-term PMAS follow-up may be more expensive.

Recurrent Cardiovascular Events in Survivors of Myocardial Infarction With ST-Segment Elevation (from the AMI-QUEBEC Study).

The characteristics and predictors of long-term recurrent ischemic cardiovascular events (RICEs) after myocardial infarction with ST-segment elevation (STEMI) have not yet been clarified. We aimed to characterize the 10-year incidence, types, and predictors of RICE. We obtained 10-year follow-up of STEMI survivors at 17 Quebec hospitals in Canada (the AMI-QUEBEC Study) in 2003. There were 858 patients; mean age was 60 years and 73% were male. The majority of patients receive reperfusion therapy; 53.3% and 39.2% of patients received primary percutaneous coronary intervention (PCI) and fibrinolytic therapy, respectively. Seventy-five percent of patients underwent in-hospital PCI (elective, rescue, and primary). At 10 years, 42% of patients suffered a RICE, with most RICEs (88%) caused by recurrent cardiac ischemia. The risk of RICE was the highest during the first year (23.5 per patient-year). At 10 years, the all-cause mortality was 19.3%, with 1/3 of deaths being RICE-related. Previous cardiovascular event, heart failure during the index STEMI hospitalization, discharge prescription of calcium blocker increased the risk of RICE by almost twofold. Each point increase in TIMI (Thrombolysis In Myocardial Infarction) score augmented the risk of RICE by 6%, whereas discharge prescription of dual antiplatelets reduced the risk of RICE by 23%. Our findings suggested that survivors of STEMI remain at high long-term risk of RICE despite high rate of reperfusion therapy and in-hospital PCI. Patients with previous cardiovascular event, in-hospital heart failure, and high TIMI score were particularly susceptible to RICE. Future studies are needed to confirm the impacts of calcium blocker and dual antiplatelets on long-term risk of RICE.

Ten-Year Statin Adherence in Survivors of ST-Segment Elevation Myocardial Infarction.

Background          Adherence to statins is often sub-optimal and declines over time. Direct costs incurred by patients are frequently cited as responsible for inadequate statin adherence. To determine whether survivors of ST-segment elevation myocardial infarction (STEMI), who benefit from low or no cost drug dispensation, have optimal long-term adherence to statins, we aimed to evaluate the ten-year adherence to statin of these patients. Methods          The AMI-QUEBEC Study follows a cohort of STEMI survivors hospitalized at 17 hospitals in Quebec, Canada during the year 2003. We obtained their 10-year data on lipid lowering therapy (LLT) consumption. Optimal adherence was defined as the proportion of days covered of ≥80%. We used multivariate logistic regression to determine factors independently associated with optimal adherence to statins. Results          Complete 10-year data on statin dispensation was available for 524 patients. Optimal adherence remained stable over time at 80% and more during the 10-year follow-up period. During the last five years, 12% of patients did not use any LLT. Older age, living in less socially deprived areas, concomitant use of angiotensin-converting-enzyme inhibitors (ACEI) or angiotensin receptor blockers (ARB), and admission to hospitals with percutaneous coronary interventions facilities (PCI-hospitals) were associated with improved statin adherence.   Conclusion Future studies are needed to explore the potential factors associated with concomitant use of ACEI/ARB, and admission to PCI-hospitals that may have optimized statin adherence. Socially deprived patients may benefit from more support and encouragement to enhance their long-term statin adherence.

Sustained Performance of a "Physicianless" System of Automated Prehospital STEMI Diagnosis and Catheterization Laboratory Activation.

BACKGROUND: Treatment times for primary percutaneous coronary intervention frequently exceed the recommended maximum delay. Automated "physicianless" systems of prehospital cardiac catheterization laboratory (CCL) activation show promise, but have been met with resistance over concerns regarding the potential for false positive and inappropriate activations (IAs). METHODS: From 2010 to 2015, first responders performed electrocardiograms (ECGs) in the field for all patients with a complaint of chest pain or dyspnea. An automated machine diagnosis of "acute myocardial infarction" resulted in immediate CCL activation and direct transfer without transmission or human reinterpretation of the ECG prior to patient arrival. Any activation resulting from a nondiagnostic ECG (no ST-elevation) was deemed an IA, whereas activations resulting from ECG's compatible with ST-elevation myocardial infarction but without angiographic evidence of a coronary event were deemed false positive. In 2012, the referral algorithm was modified to exclude supraventricular tachycardia and left bundle branch block. RESULTS: There were 155 activations in the early cohort (2010-2012; prior to algorithm modification) and 313 in the late cohort (2012-2015). Algorithm modification resulted in a 42% relative decrease in the rate of IAs (12% vs 7%; P < 0.01) without a significant effect on treatment delay. CONCLUSIONS: A combination of prehospital automated ST-elevation myocardial infarction diagnosis and "physicianless" CCL activation is safe and effective in improving treatment delay and these results are sustainable over time. The performance of the referral algorithm in terms of IA and false positive is at least on par with systems that ensure real-time human oversight.

Performance of a new "physician-less" automated system of prehospital ST-segment elevation myocardial infarction diagnosis and catheterization laboratory activation.

The door-to-balloon times frequently exceed the recommended delay. We therefore evaluated the performance of a novel "physician-less" cardiac catheterization laboratory (CCL) activation system relying on the automated electrocardiographic diagnosis alone. From January 2010 to 2012, first responders performed electrocardiograms in the field for all patients with a complaint of chest pain or dyspnea. An automated machine diagnosis of "acute myocardial infarction" resulted in immediate CCL activation and direct transfer without human reinterpretation or transmission of the electrocardiogram. Any activation resulting from a nondiagnostic ECG (no ST-segment elevation) was deemed inappropriate and classified as resulting from either human or machine error. Of 155 activations, 136 (88%) were electrocardiographically appropriate. Of these, 128 patients had a final diagnosis of ST-segment elevation myocardial infarction. A door-to-balloon time of <90 minutes was achieved in 99%, the procedural success was high (94%), and the overall mortality was low (3%). Of the electrocardiographically appropriate activations, 8 (5%) were false-positive results. The remaining 19 activations (12%) were inappropriate. Compared with the electrocardiographically appropriate activations, those with inappropriate activations had significantly greater rates of hypertension (p = 0.0070) and known coronary artery disease (p = 0.0008) and higher presenting heart rates (p <0.0001). The causes for inappropriate activation were approximately evenly split between human and machine error. In conclusion, a combination of prehospital automated ST-segment elevation myocardial infarction diagnosis and "physician-less" CCL activation was safe and effective in ensuring target door-to-balloon times in virtually all patients and resulted in an acceptable rate of inappropriate CCL activation.

Gender and other disparities in referral to specialized heart failure clinics following emergency department visits.

BACKGROUND: Persons with heart failure (HF) at high risk for adverse events should be followed by specialized HF clinics, since follow-up by specialized HF clinics improves outcomes for HF patients. The objective was to determine whether there were disparities for gender and other factors associated with referral of patients to specialized HF clinics. METHODS: In this prospective cohort study, patients with a confirmed primary diagnosis of HF were recruited by nurses at 8 hospital emergency departments (ED) in Québec, Canada. They were interviewed by telephone at 6 weeks post ED discharge and subsequently at 3 months and 6 months. Pertinent clinical variables were extracted from medical charts by trained nurses. Bivariate analysis and multiple logistic regression were used to identify whether gender and other potential factors were associated with referral to the HF clinic. RESULTS: We enrolled 549 patients (mean age 75.5±11.0 years; 51% males). By 6 months after their ED visit for HF, 37.6% of the cohort were referred to specialized HF clinics. Men were more likely to be referred (odds ratio [OR] 2.04; 95% confidence interval [CI] 1.12, 3.74). Other factors associated with referral were younger age (OR 0.95; 95% CI 0.92, 0.98), and systolic dysfunction HF (left ventricle ejection fraction <40%) (OR 3.08; 95% CI 1.77, 5.46). CONCLUSION: There are disparities in referral with respect to gender, age, and type of HF. These disparities in referral need to be addressed.

Rate dependent QS pattern in an acute Kawasaki disease.

Kawasaki disease (KD) is associated with pancarditis and complicated by coronary artery (CA) inflammation. In the present case, we were confronted with a very ill KD patient with first degree atrioventricular block and QS pattern on the electrocardiogram. This unusual pattern was transient and intermittent. It reflected a conduction disturbance in the context of an acute myocarditis rather than an immediate CA complication. We herein discuss the differential diagnoses of a rarely observed electrocardiographic finding in the young.