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BackgroundCoronary heart disease (CHD) is the leading cause of cardiovascular mortality worldwide, yet implementation of evidence-based strategies for secondary prevention remains suboptimal. ObjectiveThis study aimed to evaluate the feasibility, specifically the usability and acceptability, and estimate the preliminary effectiveness of a mobile health (mHealth) intervention targeting both physicians and patients to improve adherence to evidence-based medications and lifestyle modifications. MethodsWe conducted a 12-week pre-post interventional pilot study at two sites in Shanghai and Hainan, China. Physicians used the app designed in this study to prescribe evidence-based medicines and record patient information. Eligible and consenting patients received automatic text messages or voice calls 4 to 5 times per week for 12 weeks on medication adherence and healthy behaviors. Interviews were conducted among 10 physicians and 24 patients at the two sites for their thoughts on medication adherence and feedback on the usability and acceptability. Questions on usability and acceptability were also asked in a patient follow-up survey. With regard to estimating effectiveness, the primary outcome was medication adherence (as estimated by the Morisky Green Levine Scale) at 12 weeks. Secondary outcomes included physical activity, smoking status, fruits and vegetables consumption, and facility visit frequency. ResultsInterview findings and patient survey showed the good usability and acceptability of the intervention. Among 190 patients who completed the intervention, there was a significant increase in medication adherence (odds ratio [OR] 1.80, 95% CI 1.14-2.85). The study also showed decrease of smokers’ percentage (−5%, P=.05), increase of daily vegetables consumption frequency (+0.3/day, P=.01), and community health care center visit frequency (+3 in 3 months, P=.04). The following site-specific differences were noted: medication adherence appeared to increase in Hainan (OR 14.68, 95% CI 5.20-41.45) but not in Shanghai (OR 0.61, 95% CI 0.33-1.12). ConclusionsOur study demonstrated that the intervention was feasible in both a tertiary care center and an urban community health center in China. Preliminary results from pre-post comparison suggest the possibility that provider and patient-linked mHealth interventions may improve medication adherence and lifestyle modifications among CHD patients, especially in resource-scarce settings. Randomized controlled trials are needed to verify the findings.

Background: Patients who are receiving vitamin K antagonist (VKA) therapy pose challenges when they require surgery or invasive procedures because the risk for bleeding during the procedure must be balanced against the risk of an atherothrombotic event if the VKA is interrupted. However, it may be possible to safely perform some procedures, such as coronary angiography with or without percutaneous coronary intervention (PCI), without VKA interruption.Methods: We undertook a systematic review and metaanalysis to assess the safety of a periprocedural management strategy of uninterrupted VKA (U-VKA) vs interrupted VKA (I-VKA) with or without bridging with low-molecular-weight heparin in patients undergoing elective coronary angiography with or without PCI.Results: Eight studies were included in the review. Most were of moderate to very low quality. A strategy of U-VKA appears to confer approximately one-half the risk (odds ratio, 0.43; 95% CI, 0.26-0.73) of experiencing an access site bleeding complication within 1 week of the procedure compared with a strategy of I-VKA. The U-VKA strategy was associated with a pooled access site bleeding complication rate of 4.0% (95% CI, 3.0-7.0), and although high heterogeneity precluded pooling of such a rate in the I-VKA group, these rates ranged from 2% to 14%.Conclusion: Although it appears that coronary angiography with or without PCI can be safely performed without interrupting VKA, the low methodologic quality of existing studies precludes any definitive conclusions. Randomized trials assessing different anticoagulation strategies are needed to establish evidence-based practice guidelines in this setting. [ABSTRACT FROM AUTHOR]

Background: Taking all recommended secondary prevention cardiac medications and fully participating in a formal cardiac rehabilitation program significantly reduces mortality and morbidity in the year following a heart attack. However, many people who have had a heart attack stop taking some or all of their recommended medications prematurely and many do not complete a formal cardiac rehabilitation program. Objective: The objective of our study was to develop a user-centered, theory-based, scalable intervention of printed educational materials to encourage and support people who have had a heart attack to use recommended secondary prevention cardiac treatments. Methods: Prior to the design process, we conducted theory-based interviews and surveys with patients who had had a heart attack to identify key determinants of secondary prevention behaviors. Our interdisciplinary research team then partnered with a patient advisor and design firm to undertake an iterative, theory-informed, user-centered design process to operationalize techniques to address these determinants. User-centered design requires considering users' needs, goals, strengths, limitations, context, and intuitive processes; designing prototypes adapted to users accordingly; observing how potential users respond to the prototype; and using those data to refine the design. To accomplish these tasks, we conducted user research to develop personas (archetypes of potential users), developed a preliminary prototype using behavior change theory to map behavior change techniques to identified determinants of medication adherence, and conducted 2 design cycles, testing materials via think-aloud and semistructured interviews with a total of 11 users (10 patients who had experienced a heart attack and 1 caregiver). We recruited participants at a single cardiac clinic using purposive sampling informed by our personas. We recorded sessions with users and extracted key themes from transcripts. We held interdisciplinary team discussions to interpret findings in the context of relevant theory-based evidence and iteratively adapted the intervention accordingly. Results: Through our iterative development and testing, we identified 3 key tensions: (1) evidence from theory-based studies versus users' feelings, (2) informative versus persuasive communication, and (3) logistical constraints for the intervention versus users' desires or preferences. We addressed these by (1) identifying root causes for users' feelings and addressing those to better incorporate theory- and evidence-based features, (2) accepting that our intervention was ethically justified in being persuasive, and (3) making changes to the intervention where possible, such as attempting to match imagery in the materials to patients' self-images. Conclusions: Theory-informed interventions must be operationalized in ways that fit with user needs. Tensions between users' desires or preferences and health care system goals and constraints must be identified and addressed to the greatest extent possible. A cluster randomized controlled trial of the final intervention is currently underway. [ABSTRACT FROM AUTHOR]

Background: Timely diagnosis and treatment for ST-elevation myocardial infarction (STEMI) requires a coordinated response from multiple providers. Rapid intervention is key to reducing mortality and morbidity. Activation of the cardiac catheterization laboratory may occur through verbal communication and may also involve the secure sharing of electrocardiographic images between frontline health care providers and interventional cardiologists. To improve this response, we developed a quick, easy-to-use, privacy-compliant smartphone app, that is SMART AMI-ACS (Strategic Management of Acute Reperfusion and Therapies in Acute Myocardial Infarction Acute Coronary Syndromes), for real-time verbal communication and sharing of electrocardiographic images among health care providers in Ontario, Canada. The app further provides information about diagnosis, management, and risk calculators for patients presenting with acute coronary syndrome., Objective: This study aims to integrate the app into workflow processes to improve communication for STEMI activation, resulting in decreased treatment times, improved patient outcomes, and reduced unnecessary catheterization laboratory activation and transfer., Methods: Implementation of the app will be guided by the Reach, Effectiveness, Acceptability, Implementation, and Maintenance (RE-AIM) framework to measure impact. The study will use quantitative registry data already being collected through the SMART AMI project (STEMI registry), the use of the SMART AMI app, and quantitative and qualitative survey data from physicians. Survey questions will be based on the Consolidated Framework for Implementation Research. Descriptive quantitative analysis and thematic qualitative analysis of survey results will be conducted. Continuous variables will be described using either mean and SD or median and IQR values at pre- and postintervention periods by the study sites. Categorical variables, such as false activation, will be described as frequencies (percentages). For each outcome, an interrupted time series regression model will be fitted to evaluate the impact of the app., Results: The primary outcomes of this study include the usability, acceptability, and functionality of the app for physicians. This will be measured using electronic surveys to identify barriers and facilitators to app use. Other key outcomes will measure the implementation of the app by reviewing the timing-of-care intervals, false "avoidable" catheterization laboratory activation rates, and uptake and use of the app by physicians. Prospective evaluation will be conducted between April 1, 2022, and March 31, 2023. However, for the timing- and accuracy-of-care outcomes, registry data will be compared from January 1, 2019, to March 31, 2023. Data analysis is expected to be completed in Fall 2024, with the completion of a paper for publication anticipated by the end of 2024., Conclusions: Smartphone technology is well integrated into clinical practice and widely accessible. The proposed solution being tested is secure and leverages the accessibility of smartphones. Emergency medicine physicians can use this app to quickly, securely, and accurately transmit information ensuring faster and more appropriate decision-making for STEMI activation., Trial Registration: ClinicalTrials.gov NCT05290389; https://clinicaltrials.gov/study/NCT05290389., International Registered Report Identifier (irrid): DERR1-10.2196/55506., (©Hassan Mir, Katelyn J Cullen, Karen Mosleh, Rafi Setrak, Sanjit Jolly, Michael Tsang, Gregory Rutledge, Quazi Ibrahim, Michelle Welsford, Mathew Mercuri, JD Schwalm, Madhu K Natarajan. Originally published in JMIR Research Protocols (https://www.researchprotocols.org), 06.09.2024.)

Background: The learning curve for new operators performing ultrasound-guided transfemoral access (TFA) remains uncertain., Methods: We performed a pooled analysis of the FAUST (Femoral Arterial Access With Ultrasound Trial) and UNIVERSAL (Routine Ultrasound Guidance for Vascular Access for Cardiac Procedures) trials, both multicenter randomized controlled trials of 1:1 ultrasound-guided versus non-ultrasound-guided TFA for coronary procedures. Outcomes included the composite of major bleeding or vascular complications and successful common femoral artery cannulation. Participants were stratified by the operators' accrued case volume. We used adjusted repeated-measurement logistic regression, with random intercepts for operator clustering, for comparison against the non-ultrasound-guided TFA group and to model the learning curve., Results: The FAUST and UNIVERSAL trials randomized a total of 1624 patients, of which 810 were randomized to non-ultrasound-guided TFA and 814 to ultrasound-guided TFA (cases 1-10, 391; 11-20, 183; and >20, 240). Participants who had operators who performed >20 ultrasound-guided TFAs had a decreased risk for the primary end point (5/240 [2.1%] versus 64/810 [7.9%]; adjusted odds ratio, 0.26 [95% CI, 0.09-0.61]) compared with non-ultrasound-guided TFA. Operators who performed >20 ultrasound-guided procedures had increased odds of successfully cannulating the common femoral artery (224/246 [91.1%] versus 327/382 [85.6%]; adjusted odds ratio, 1.76 [95% CI, 1.08-2.89]) compared with non-ultrasound-guided TFA. The learning curve plots demonstrated growing competence with increasing accrued cases., Conclusions: New operators should perform at least 20 ultrasound-guided TFA to decrease access site complications and increase proper cannulation compared with non-ultrasound-guided TFA. Additional accrued cases may lead to increased proficiency. Training programs should consider these findings in the transradial era., Competing Interests: Dr d’Entremont is a Canadian Institutes of Health Research Canada Graduate Scholarship awardee. Dr Jolly reports receiving grants or contracts from Boston Scientific and payment or honoraria for lectures, presentations, speaker’s bureaus, article writing, or educational events from Penumbra, Teleflex, and Abiomed. Dr Seto reports receiving grants or contracts from Arena Medical, Philips, and ACIST; payment or honoraria for speaker’s bureaus from Janssen, Terumo, Gettinge, and GE Healthcare; consulting fees from Medtronic and Medicure; and reports having equity in Frond Medical. The other authors report no conflicts.

Competing Interests: The authors declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Because of the COVID-19 pandemic, several health care services, including cardiac rehabilitation (CR), had to transition to virtual delivery, for which formal evaluations are lacking. In this pilot study, we investigated the implementation of a virtual CR program by surveying 30 patients attending virtual CR. Virtual CR was well received, although patients provided recommendations to improve delivery such as offering individual sessions and changing how education materials were delivered. Virtual delivery of CR likely has a role in health care, either independently or as part of a hybrid model; however, further evaluation is required., (© 2023 The Authors.)

Background: The optimal strategy to prevent no-reflow in ST-elevation myocardial infarction (STEMI) patients undergoing percutaneous coronary intervention (PCI) is unknown., Aims: We aimed to examine the effect of thrombectomy on the outcome of no-reflow in key subgroups and the adverse clinical outcomes associated with no-reflow., Methods: We performed a post hoc analysis of the TOTAL Trial, a randomised trial of 10,732 patients comparing thrombectomy versus PCI alone. This analysis utilised the angiographic data of 1,800 randomly selected patients., Results: No-reflow was diagnosed in 196 of 1,800 eligible patients (10.9%). No-reflow occurred in 95/891 (10.7%) patients randomised to thrombectomy compared with 101/909 (11.1%) in the PCI-alone arm (odds ratio [OR] 0.95, 95% confidence interval [CI]: 0.71-1.28; p-value=0.76). In the subgroup of patients who underwent direct stenting, those randomised to thrombectomy compared with PCI alone experienced less no-reflow (19/371 [5.1%] vs 21/216 [9.7%], OR 0.50, 95% CI: 0.26-0.96). In patients who did not undergo direct stenting, there was no difference between the groups (64/504 [12.7%] vs 75/686 [10.9%)], OR 1.18, 95% CI: 0.82-1.69; interaction p-value=0.02). No-reflow patients had a significantly increased risk of experiencing the primary composite outcome (cardiovascular death, recurrent myocardial infarction, cardiogenic shock, or NYHA Class IV heart failure) at 1 year (adjusted hazard ratio 1.70, 95% CI: 1.13-2.56; p-value=0.01)., Conclusions: In patients with STEMI treated by PCI, thrombectomy did not reduce no-reflow in all patients but may be synergistic with direct stenting. No-reflow is associated with increased adverse clinical outcomes.

Background: Whether ultrasound (US)-guided femoral access compared to femoral access without US guidance decreases access site complications in patients receiving a vascular closure device (VCD) is unclear., Aims: We aimed to compare the safety of VCD in patients undergoing US-guided versus non-US-guided femoral arterial access for coronary procedures., Methods: We performed a prespecified subgroup analysis of the UNIVERSAL trial, a multicentre randomised controlled trial of 1:1 US-guided femoral access versus non-US-guided femoral access, stratified for planned VCD use, for coronary procedures on a background of fluoroscopic landmarking. The primary endpoint was a composite of major Bleeding Academic Research Consortium 2, 3 or 5 bleeding and vascular complications at 30 days., Results: Of 621 patients, 328 (52.8%) received a VCD (86% ANGIO-SEAL, 14% ProGlide). In patients who received a VCD, those randomised to US-guided femoral access compared to non-US-guided femoral access experienced a reduction in major bleeding or vascular complications (20/170 [11.8%] vs 37/158 [23.4%], odds ratio [OR] 0.44, 95% confidence interval [CI]: 0.23-0.82). In patients who did not receive a VCD, there was no difference between the US- and non-US-guided femoral access groups, respectively (20/141 [14.2%] vs 13/152 [8.6%], OR 1.76, 95% CI: 0.80-4.03; interaction p=0.004)., Conclusions: In patients receiving a VCD after coronary procedures, US-guided femoral access was associated with fewer bleeding and vascular complications compared to femoral access without US guidance. US guidance for femoral access may be particularly beneficial when VCD are used.

Background: In patients with ST-segment elevation myocardial infarction (STEMI), early initiation of high-intensity statin therapy, regardless of low-density lipoprotein (LDL) cholesterol levels, is the standard of practice worldwide.  Aims: We sought to determine the effect of a similar early initiation strategy, using a proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor added to the high-intensity statin, on LDL cholesterol in acute STEMI., Methods: In a randomised, double-blind trial we assigned 68 patients with STEMI undergoing primary percutaneous coronary intervention (PCI) to early treatment with alirocumab 150 mg subcutaneously or to a matching sham control. The first injection was given before primary PCI regardless of the baseline LDL level, then at 2 and 4 weeks. The primary outcome was the percent reduction in direct LDL cholesterol up to 6 weeks, analysed using a linear mixed model.   Results: High-intensity statin use was 97% and 100% in the alirocumab and sham-control groups, respectively. At a median of 45 days, the primary outcome of LDL cholesterol decreased by 72.9% with alirocumab (2.97 mmol/L to 0.75 mmol/L) versus 48.1% with the sham control (2.87 mmol/L to 1.30 mmol/L), for a mean between-group difference of -22.3% (p<0.001). More patients achieved the European Society of Cardiology/European Atherosclerosis Society dyslipidaemia guideline target of LDL ≤1.4 mmol/L in the alirocumab group (92.1% vs 56.7%; p<0.001). Within the first 24 hours, LDL declined slightly more rapidly in the alirocumab group than in the sham-control group (-0.01 mmol/L/hour; p=0.03) with similar between-group mean values.  Conclusions: In this randomised trial of routine early initiation of PCSK9 inhibitors in patients undergoing primary PCI for STEMI, alirocumab reduced LDL cholesterol by 22% compared with sham control on a background of high-intensity statin therapy. A large trial is needed to determine if this simplified approach followed by long-term therapy improves cardiovascular outcomes in patients with acute STEMI. (ClinicalTrials.gov: NCT03718286).

Background: Coronary computed tomographic angiography (CCTA) is preferable to invasive coronary angiography (ICA) for coronary artery disease (CAD) diagnosis in elective patients without known CAD., Methods: We conducted a nonrandomized interventional study involving 2 tertiary care centres in Ontario. From July 2018 to February 2020, outpatients referred for elective ICA were identified through a centralized triage process and were recommended to undergo CCTA first instead of ICA. Patients with borderline or obstructive CAD on CCTA were recommended to undergo subsequent ICA. Intervention acceptability, fidelity, and effectiveness were assessed., Results: A total of 226 patients were screened, with 186 confirmed to be eligible, of whom 166 had patient and physician approval to proceed with CCTA (89% acceptability). Among consenting patients, 156 (94%) underwent CCTA first; 43 (28%) had borderline/obstructive CAD on CCTA, and only 1 with normal/nonobstructive CAD on CCTA was referred for subsequent ICA against protocol (99% fidelity). Overall, 119 of 156 CCTA-first patients did not have ICA within the following 90 days (i.e., 76% potentially avoided ICA, due to the intervention). Among the 36 who underwent ICA post-CCTA per protocol, 24 had obstructive CAD (66.7% diagnostic yield). If all patients who were referred for and underwent ICA at either centre between July 2016 and February 2020 (n = 694 pre-implementation; n = 333 post-implementation) had had CCTA first, an additional 42 patients per 100 would have had an obstructive CAD finding on their ICA (95% confidence interval = 26-59)., Conclusion: A centralized triage process, in which elective outpatients referred for ICA are instead referred for CCTA first, appears to be acceptable and effective in diagnosing obstructive CAD and improving efficiencies in our healthcare system., (© 2022 The Authors.)

Importance: A significant limitation of femoral artery access for cardiac interventions is the increased risk of vascular complications and bleeding compared with radial access. Strategies to make femoral access safer are needed., Objective: To determine whether routinely using ultrasonography guidance for femoral arterial access for coronary angiography/intervention reduces bleeding or vascular complications., Design, Setting, and Participants: The Routine Ultrasound Guidance for Vascular Access for Cardiac Procedures (UNIVERSAL) randomized clinical trial is a multicenter, prospective, open-label trial of ultrasonography-guided femoral access vs no ultrasonography for coronary angiography or intervention with planned femoral access. Patients were randomized from June 26, 2018, to April 26, 2022. Patients with ST-elevation myocardial infarction were not eligible., Interventions: Ultrasonography guidance vs no ultrasonography guidance for femoral arterial access on a background of fluoroscopic landmarking., Main Outcomes and Measures: The primary composite outcome is the composite of major bleeding based on the Bleeding Academic Research Consortium 2, 3, or 5 criteria or major vascular complications within 30 days., Results: A total of 621 patients were randomized at 2 centers in Canada (mean [SD] age, 71 [10.24] years; 158 [25.4%] female). The primary outcome occurred in 40 of 311 patients (12.9%) in the ultrasonography group vs 50 of 310 patients (16.1%) without ultrasonography (odds ratio, 0.77 [95% CI, 0.49-1.20]; P = .25). The rates of Bleeding Academic Research Consortium 2, 3, or 5 bleeding were 10.0% (31 of 311) vs 10.7% (33 of 310) (odds ratio, 0.93 [95% CI, 0.55-1.56]; P = .78). The rates of major vascular complications were 6.4% (20 of 311) vs 9.4% (29 of 310) (odds ratio, 0.67 [95% CI, 0.37-1.20]; P = .18). Ultrasonography improved first-pass success (277 of 311 [86.6%] vs 222 of 310 [70.0%]; odds ratio, 2.76 [95% CI, 1.85-4.12]; P < .001) and reduced the number of arterial puncture attempts (mean [SD], 1.2 [0.5] vs 1.4 [0.8]; mean difference, -0.26 [95% CI, -0.37 to -0.16]; P < .001) and venipuncture (10 of 311 [3.1%] vs 37 of 310 [11.7%]; odds ratio, 0.24 [95% CI, 0.12-0.50]; P < .001) with similar times to access (mean [SD], 114 [185] vs 129 [206] seconds; mean difference, -15.1 [95% CI, -45.9 to 15.8]; P = .34). All prerandomization prespecified subgroups were consistent with the overall finding., Conclusions and Relevance: In this randomized clinical trial, use of ultrasonography for femoral access did not reduce bleeding or vascular complications. However, ultrasonography did reduce the risk of venipuncture and number of attempts. Larger trials may be required to demonstrate additional potential benefits of ultrasonography-guided access., Trial Registration: ClinicalTrials.gov Identifier: NCT03537118.

Aims: The optimal strategy of monitoring for conduction disturbances in patients undergoing transcatheter aortic valve implantation (TAVI) is uncertain. We evaluated a pre- and post-TAVI remote ambulatory cardiac monitoring (rACM) strategy for identification of conduction disturbances and to reduce unplanned pre-discharge post-TAVI permanent pacemaker implantation (PPMI)., Methods and Results: REdireCT TAVI (NCT0381820) was a prospective cohort study of patients referred for outpatient TAVI. Patients with prior PPMI were excluded. Remote ambulatory cardiac monitoring consisted of 2 weeks of continuous electrocardiogram (ECG) monitoring (Pocket-ECGTM) both before and after TAVI. Compliance to monitoring, frequency of notifications, unplanned PPMI post-TAVI, and length of hospitalization were measured. Between June 2018 and March 2020, in 192 undergoing TAVI (mean age: 81.8 years; female sex 46%; balloon-expandable valve 95.3%), compliance to rACM was 91.7% pre-TAVI (mean duration: 12.8 days), and 87.5% post-TAVI (mean duration: 12.9 days). There were 24 (12.5%) rACM notifications (13 pre-TAVI; 11 post-TAVI) resulting in 14 (7.3%) planned PPMI: seven pre-TAVI [due to sinus pauses n = 2 or atrio-ventricular block (AVB) n = 5] and seven post-TAVI [due to sinus pauses n = 1 or AVB n = 5 or ventricular tachycardia (VT) n = 1]. In addition, nine (4.7%) patients received pre-TAVI PPMI due to high-risk baseline ECG (right bundle branch block with hemi-block or prolonged PR interval). Unplanned PPMI post-TAVI during index hospitalization occurred in six (3.1%) patients due to AVB and in one patient readmitted with AVB. The median length of stay post-TAVI was 1 day., Conclusion: A strategy of routine rACM was feasible and frequently led to PPMI. Our approach of 2-week rACM both pre- and post-TAVI achieves both high patient compliance and sufficient surveillance., Clinical Trial Registration: Clinical Trial Registration: https://clinicaltrials.gov/ct2/show/NCT03810820., Competing Interests: Conflict of interest: none declared., (© The Author(s) 2022. Published by Oxford University Press on behalf of the European Society of Cardiology. All rights reserved. For permissions, please email: journals.permissions@oup.com.)

Investigating the mechanisms of behavior change interventions provides a more fulsome understanding of how and why interventions work (or don't work). We assessed mechanisms of two interventions (mailouts alone, and mailouts plus telephone support, informed by the Health Action Process Approach (HAPA) and Habit Theory), designed to increase medication adherence after myocardial infarction. We conducted a process evaluation alongside a pragmatic trial. Medication adherence was assessed via self-report at 12-months in the trial, and participants in all trial groups were invited to contemporaneously complete an additional questionnaire assessing targeted mechanisms (HAPA constructs and automaticity). We used multiple regression-based mediation models to investigate indirect effects. Of 589 respondents, 497 were analyzed (92 excluded due to missing data). Mailouts plus telephone support had statistically significant but small effects on intention, social support, action planning, coping planning, and automaticity. There were no indirect effects of interventions on medication adherence via these constructs. Therefore, while this intervention led to changes in proposed mechanisms, these changes were not great enough to lead to behavior change. Refinements (and subsequent evaluation) of the interventions are warranted, and our findings indicate that this could involve offering more intensive support to form plans and identify cues for taking medications, in addition to providing physical supports to encourage self-monitoring, feedback, and habit formation. Trial registration: ClinicalTrials.gov: NCT02382731., (© 2022. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.)

Background: A significant limitation of femoral artery access for cardiac interventions is the increased risk of vascular complications and bleeding compared to radial access. Ultrasound (US)-guided femoral access may reduce major vascular complications and bleeding. We aim to determine whether routinely using US guidance for femoral arterial access for coronary angiography or intervention will reduce B leeding A cademic R esearch C onsortium (BARC) 2, 3, or 5 bleeding or major vascular complications., Methods: The U ltrasou n d Gu i dance for V ascular Acc e ss fo r Cardiac Procedure s : A Randomized Tria l (UNIVERSAL) is a multicentre, prospective, open-label, randomized trial with blinded outcomes assessment. Patients undergoing coronary angiography with or without intervention via a femoral approach with fluoroscopic guidance will be randomized 1:1 to US-guided femoral access, compared to no US. The primary outcome is the composite of major bleeding based on the BARC 2, 3, or 5 criteria or major vascular complications within 30 days. The trial is designed to have 80% power and a 2-sided alpha level of 5% to detect a 50% relative risk reduction for the primary outcome based on a control event rate of 14%., Results: We completed enrollment on April 29, 2022, with 621 randomized patients. The patients had a mean age of 71 years (25.4% female), with a high rate of comorbidities, as follows: 45% had a prior percutaneous coronary intervention; 57% had previous coronary artery bypass surgery; and 18% had peripheral vascular disease., Conclusions: The UNIVERSAL trial will be one of the largest randomized trials of US-guided femoral access and has the potential to change guidelines and increase US uptake for coronary procedures worldwide., (© 2022 The Authors.)

Background: Preliminary evidence suggests that providing longer duration prescriptions at discharge may improve long-term adherence to secondary preventative cardiac medications among post-myocardial infarction (MI) patients. We implemented and assessed the effects of two hospital-based interventions-(1) standardized prolonged discharge prescription forms (90-day supply with 3 repeats for recommended cardiac medications) plus education and (2) education only-on long-term cardiac medication adherence among elderly patients post-MI., Methods: We conducted an interrupted time series study of all post-MI patients aged 65-104 years in Ontario, Canada, discharged from hospital between September 2015 and August 2018 with ≥ 1 dispensation(s) for a statin, beta blocker, angiotensin system inhibitor, and/or secondary antiplatelet within 7 days post-discharge. The standardized prolonged discharge prescription forms plus education and education-only interventions were implemented at 2 (1,414 patients) and 4 (926 patients) non-randomly selected hospitals in September 2017 for 12 months, with all other Ontario hospitals (n = 143; 18,556 patients) comprising an external control group. The primary outcome, long-term cardiac medication adherence, was defined at the patient-level as an average proportion of days covered (over 1-year post-discharge) ≥ 80% across cardiac medication classes dispensed at their index fill. Primary outcome data were aggregated within hospital groups (intervention 1, 2, or control) to monthly proportions and independently analyzed using segmented regression to evaluate intervention effects. A process evaluation was conducted to assess intervention fidelity., Results: At 12 months post-implementation, there was no statistically significant effect on long-term cardiac medication adherence for either intervention-standardized prolonged discharge prescription forms plus education (5.4%; 95% CI - 6.4%, 17.2%) or education only (1.0%; 95% CI - 28.6%, 30.6%)-over and above the counterfactual trend; similarly, no change was observed in the control group (- 0.3%; 95% CI - 3.6%, 3.1%). During the intervention period, only 10.8% of patients in the intervention groups received ≥ 90 days, on average, for cardiac medications at their index fill., Conclusions: Recognizing intervention fidelity was low at the pharmacy level, and no statistically significant post-implementation differences in adherence were found, the trends in this study-coupled with other published retrospective analyses of administrative data-support further evaluation of this simple intervention to improve long-term adherence to cardiac medications., Trial Registration: ClinicalTrials.gov : NCT03257579 , registered June 16, 2017 Protocol available at: https://pubmed.ncbi.nlm.nih.gov/33146624/ ., (© 2022. The Author(s).)

Background: Early reperfusion in patients with ST-segment elevation myocardial infarction (STEMI) has been associated with preservation of left ventricular function and decrease in mortality. Symptom onset to first medical contact (FMC) time consumes the majority of total ischemic time, and remains one of the main reasons that patients do not receive timely care. With FMC to reperfusion time being effectively reduced in many parts of the world, the focus is now shifting to reducing symptom onset to FMC times., Methods: This mixed-methods observational study was designed to elucidate factors affecting symptom onset to FMC time at a regional cardiac center in a low-middle income country (LMIC) and a high-income country (HIC). A review of the Aswan Heart Center and Hamilton General Hospital STEMI registry in Egypt and Canada was conducted, and retrospective semi-structured questionnaires carried out for a convenience sample of 158 patients., Results: Gender, symptom type and severity were none-modifiable factors found between early and late presenters. Modifiable factors found were actions of bystanders, actions of patients, transportation method and time. Emotional factors also showed differences between the two groups., Conclusion: While some concepts are generalizable, contextual differences in demographics, risk factors, access and knowledge are identified. These factors can be used to inform tailored knowledge translation strategies to help reduce symptom onset to FMC in both LMIC and HIC., Competing Interests: The authors report no relationships that could be construed as a conflict of interest., (© 2022 The Author(s).)

Workplace violence is a common safety concern for hospital staff. The Behaviour Safety Risk Communication and Care Planning program identifies, manages and cares for patients at risk of exhibiting unsafe behaviours. This paper reports on a mixed-methods evaluation consisting of staff surveys, focus groups and open forums, screening audits, patient interviews and assessment of effectiveness measures at five hospital sites. Staff perceptions about safety risk imposed by a patient's behaviour significantly improved after this program was implemented. Opportunities exist to improve staff adherence to screening processes and communication with patients. This study provides insight for teams implementing similar interventions., (Copyright © 2022 Longwoods Publishing.)

Background: Conventional clinical risk scores and diagnostic algorithms are proving to be suboptimal in the prediction of obstructive coronary artery disease, contributing to the low diagnostic yield of invasive angiography. Machine learning could help better predict which patients would benefit from invasive angiography vs other noninvasive diagnostic modalities., Objective: To reduce patient risk and cost to the healthcare system by improving the diagnostic yield of invasive coronary angiography through optimized outpatient selection., Methods: Retrospective analysis of 12 years of referral data from a provincial cardiac registry, including all patients referred for invasive angiography of more than 1.4 million individuals in Ontario, Canada. Stable outpatients undergoing coronary angiography during the study period were included in the analysis. The training set (80% random sample, n = 23,750) was used to develop 8 prediction models in Python using grid-search cross-validation. The test set (20% random sample, n = 5938), evaluated the discrimination performance of each model., Results: The machine-learning model achieved a substantially better performance (area under the receiver operating characteristics curve: 0.81) than existing models for predicting obstructive coronary artery disease in patients referred for invasive angiography. It significantly outperformed both the reference model and current clinical practice with a net reclassification index of 27.8% (95% confidence interval [CI]: [24.9%-30.8%], P value <.01) and 44.7% (95% CI: [42.4%-47.0%], P value <.01), respectively., Conclusion: This prediction model, when coupled with a point-of-care, online decision support tool to be used by referring physicians, could improve the diagnostic yield of invasive coronary angiography in stable, elective outpatients, thus improving patient safety and reducing healthcare costs., (© 2021 Heart Rhythm Society.)

A survey evaluation was conducted in the division of cardiology at a tertiary care academic centre to assess barriers, facilitators, acceptability, and feasibility of virtual care during the COVID-19 pandemic. Survey responses from 26 health care providers, 45 patients, and 2 caregivers showed that virtual visits (primarily by telephone) were feasible and generally acceptable to most respondents. Key opportunities for improvement included availability of easy-to-use video platforms, space and equipment in clinics, provision of information to patients before visits, and appropriate selection of patients for virtual visits. Results will inform optimization of virtual care during this pandemic and beyond., (© 2021 The Authors.)

Background: In patients with atrial fibrillation (AF) undergoing percutaneous coronary intervention (PCI), selecting an antithrombotic regimen requires balancing risks of ischemic cardiac events, stroke, and bleeding., Methods: We studied 467 patients with AF undergoing PCI in the time period from December 2015 to July 2018 identified via a chart audit by 47 Canadian cardiologists in the CONNECT AF+PCI (the Co ordinated N ational N etwork to E ngage Interventional C ardiologists in the Antithrombotic T reatment of Patients With A trial F ibrillation Undergoing P ercutaneous C oronary I ntervention) study, to determine patterns of initial antithrombotic therapy selection., Results: The median (25th, 75th percentile) CHADS 2 score was 2 (1, 3), and PCI was performed in the setting of acute coronary syndrome in 62.1%. Triple antithrombotic therapy (TAT) was the initial treatment in 62.7%, dual-pathway therapy in 25.7%, and dual antiplatelet therapy in 11.6%, with a temporal increase in use of dual-pathway therapy during the course of the study; median intended TAT duration was 1 (1, 3) month. Compared with patients selected for TAT, patients selected for dual-pathway therapy were less likely to have prior myocardial infarction (35.8% vs 25.8%, P  = 0.045) and prior PCI (33.8% vs 23.3%, P  = 0.03), and they received shorter total length of stents (38 [23, 56] vs 30 [20, 46] mm, P  = 0.03). Patients selected for dual-pathway therapy had a higher prevalence of prior stroke/transient ischemic attack (13.0% vs 23.3%, P  = 0.01). There was no difference in prevalence of anemia (21.5% vs 25.8%, P  = 0.30). Use of dual-pathway therapy was similar among patients with acute coronary syndrome and those with stable disease (24.1% vs 28.2%, P  = 0.32)., Conclusions: Approximately one-quarter of AF patients undergoing PCI are treated with dual-pathway therapy in Canadian practice, with its use increasing during the studied period. Patients selected for dual-pathway therapy have less-complex coronary disease history and intervention., (© 2021 The Authors.)

Background: Guidelines recommend both acetylsalicylic acid and ticagrelor following acute coronary syndrome (ACS), but appropriate prescription practices lag. We analyzed the impact of government medication approval, national guideline updates, and publicly funded drug coverage plans on P2Y12 inhibitor utilization., Methods: Accessing provincial databases, we obtained data for elderly ACS patients in Ontario, Canada, between 2008 and 2018. Using interrupted-time series with descriptive statistics and segmented regression analysis, we evaluated types of P2Y12 inhibitors prescribed at discharge and changes to their utilization in patients managed with percutaneous intervention (PCI), coronary artery bypass grafting (CABG) or medically, following national antiplatelet therapy guidelines (by the Canadian Cardiovascular Society), ticagrelor's national approval by Health Canada, and ticagrelor's coverage by a publicly funded medication plan., Results: We included 114,142 patients (49.4%-PCI; mean age 75.71±6.94 and 62.3% male and 7.7%-CABG; mean age 74.11±5.63 and 73.5% male). Among PCI patients, clopidogrel utilization declined monthly after 2010 national guidelines were published (p<0.0001) and within the first month after ticagrelor's national approval by Health Canada (p=0.03). Among PCI patients, ticagrelor utilization increased within the first month (p<0.0001) and continued increasing monthly (p<0.0001) after its coverage by a publicly funded medication plan. Among PCI patients, clopidogrel utilization declined within the first month (p=0.003) and ticagrelor utilization increased monthly (p=0.05) after 2012 CCS guidelines. Among CABG patients, ticagrelor's coverage was associated with a monthly increase in its utilization (p<0.0001)., Conclusion: National guideline updates and drug coverage by a publicly funded medication plan significantly improved P2Y12 inhibitor utilization. Barriers to appropriate antiplatelet therapy in the surgical population must be explored.

Background: The objective of this study was to evaluate adherence to guideline-recommended cardiac secondary prevention therapies by immigration and ethnicity., Methods: We conducted a retrospective substudy of the I nterventions S upporting L ong-Term A dherence and D ecreasing Cardiovascular Events (ISLAND) randomized controlled trial. A cohort of 1642 participants was analyzed. Patients were categorized based on their self-reported immigrant status as being Canadian or foreign born and based on their visual minority status (as European or a visual minority). We used logistic regression to examine associations between these patient characteristics of interest and patient adherence to statin medication 1 year after myocardial infarction (MI) and completion of cardiac rehabilitation, adjusting for age, sex, and comorbidities., Results: The dataset included outcome data on 1049 (64%) Canadian-born patients and 593 (36%) immigrants. There were 347 (21%) who identified as a visual minority. We report a nonsignificant trend in statin adherence 1 year after MI favouring foreign-born participants compared with Canadian-born participants (odds ratio [OR], 1.26; 95% confidence interval [CI], 0.91-1.68). Visual minorities were found to have no significant difference in statin adherence 1 year after MI compared with participants of European ethnicity (OR, 1.04; 95% CI, 0.72-1.51). Neither immigration status (OR, 0.91; 95% CI, 0.72-1.15) nor visual minority status (OR, 0.97; 95% CI, 0.73-1.28) were associated with cardiac rehabilitation completion., Conclusions: Our findings offer limited support that immigrants with > 10 years of Canadian residency exposure experience greater adherence to statins 1 year after MI. Further research is required to better inform our understanding of secondary prevention strategy among immigrant populations., (© 2021 The Authors.)

Background: Mobile health (mHealth) interventions can improve health by improving cardiovascular risk factors, but their adoption in care by physicians and patients is untapped. Few mHealth apps have been evaluated in clinical trials, and due to the fast pace of technological development, those previously evaluated are often outdated by the time trial results are available. Given the rapid pace of change in this field, it is not feasible to rigorously evaluate mHealth apps with current methodologies., Objective: The overall aim of this pilot study was to test the feasibility of using a web research platform called Trial My App to conduct efficient and rigorous web-based randomized controlled trials (RCTs) of mHealth apps relevant to patients with cardiovascular risk factors by evaluating an app that targets hypertension., Methods: For this study, 200 participants with suboptimally controlled hypertension will be recruited through advertisements in newsletters, media, and the internet, as well as through referrals from their health care providers. Screening, consent, randomization, and collection of patient-important health confidence and self-management ability outcomes will be conducted online through the Trial My App research platform. Participants will be randomized into 2 groups: 100 that will use an mHealth app for tracking hypertension and 100 that will be considered as an educational control. All participants will complete questionnaires at 0, 1, 3 and 6 months after enrolment. A substudy to validate the method of blood pressure readings and the consistency of data entered through Trial My App will be conducted with 40 participants., Results: The development of the Trial My App web platform has been completed. The creation of survey instruments has been completed in collaboration with our patient partners and advisory board. Recruitment is expected to begin in the first quarter of 2021; data collection and analysis are expected to be completed approximately 1 year after study commencement. Results will be disseminated through conferences and publications. The primary outcomes of this study include the feasibility of conducting an RCT using the Trial My App platform by reporting recruitment, retention, and completion statistics. We will validate app-entered data with a standard 7-day home blood pressure measurement method. Lastly, the pilot, nonblinded RCT will assess the effectiveness of the mHealth app in improving the control of hypertension compared with the control of hypertension in the educational control group., Conclusions: This study will determine if it is feasible to use the Trial My App web-based platform to evaluate the effectiveness of mHealth apps for patients with cardiovascular risk factors. As more mHealth apps are evaluated in RCTs, patients will be able to select apps that meet their needs and physicians will be able to make evidence-based recommendations to their patients for apps aimed at improving cardiovascular health., Trial Registration: ClinicalTrials.gov NCT04528654; https://clinicaltrials.gov/ct2/show/NCT04528654., International Registered Report Identifier (irrid): PRR1-10.2196/26155., (©Cynthia Lokker, Rita Jezrawi, Itzhak Gabizon, Jobin Varughese, Michael Brown, Dan Trottier, Elizabeth Alvarez, Jon-David Schwalm, Michael McGillion, Jinhui Ma, Vinai Bhagirath. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 01.02.2021.)

Workplace violence prevention of patient behaviours is a primary safety focus in hospital settings. In response to provincial mandates, a multi-site tertiary care hospital system developed the Behaviour Safety Risk Communication and Care Planning Program. Components include patient risk screening, communication tools and care plans that outline mitigation strategies. The program has been implemented at six sites using the following strategies: educational and planning meetings, formation of steering committees, identification of champions, educational materials/training, facilitation and consultation, and audit and feedback. Our paper can guide program development and implementation in similar contexts., (Copyright © 2021 Longwoods Publishing.)

Objective: A randomized trial informed by the Health Action Process Approach evaluated interventions to improve cardiac rehabilitation completion following myocardial infarction. We investigated indirect effects of the interventions on completion via targeted constructs., Methods: In this theory-based process evaluation, participants in all 3 trial arms (usual care; mailouts; mailouts plus telephone support) completed a questionnaire 12 months after their myocardial infarction assessing intention, goal priority, outcome expectancies, risk perception, self-efficacy, social support, action planning, and coping planning. Consecutive sampling was used until the target sample size (167 per trial arm) was met. Cardiac rehabilitation completion was self-reported at the same time point. We used multiple regression mediation models to explore indirect effects., Results: In total, 594 participants completed the cardiac rehabilitation questionnaire; 588 were analyzed (6 excluded due to missing data). For mailouts alone, there were no significant indirect effects. There were small indirect effects of mailouts plus telephone support on intention via goal priority, outcome expectancies, and self-efficacy, with a negative effect via severity risk perception. There were also small indirect effects on cardiac rehabilitation completion via self-efficacy and action planning., Conclusions: Findings help explain the trial results, suggesting that mailouts plus telephone support increased the likelihood of completing cardiac rehabilitation by enhancing self-efficacy and action planning, and increased intention by enhancing goal priority, self-efficacy, and outcome expectancies, with an unintended consequence of a negative effect via risk perceptions. Conducting theory-based process evaluations alongside trials of behavior change interventions can clarify mechanisms of action, which can inform efforts to refine interventions and to replicate and generalize findings to other jurisdictions. (PsycInfo Database Record (c) 2020 APA, all rights reserved).