New-onset atrial fibrillation detected by ambulatory ECG monitoring after transcatheter aortic valve implantation.

BACKGROUND: Little is known about the occurrence of subclinical new-onset atrial fibrillation (NOAF) after transcatheter aortic valve implantation (TAVI). AIMS: We aimed to evaluate the incidence, predictors, and clinical impact of subclinical NOAF after TAVI. METHODS: This was a multicentre study, including patients with aortic stenosis (AS) and no previous atrial fibrillation undergoing TAVI, with continuous ambulatory electrocardiogram (AECG) monitoring after TAVI. RESULTS: A total of 700 patients (79±8 years, 49% female, Society of Thoracic Surgeons score 2.9% [1.9-4.0]) undergoing transarterial TAVI were included (85% balloon-expandable valves). AECG was started 1 (0-1) day after TAVI (monitoring time: 14121314 days). NOAF was detected in 49 patients (7%), with a median duration of 185 (43-421) minutes (atrial fibrillation burden of 0.7% [0.3-2.8]). Anticoagulation was started in 25 NOAF patients (51%). No differences were found in baseline or procedural characteristics, except for a higher AS severity in the NOAF group (peak gradient: no NOAF: 71.9±23.5 mmHg vs NOAF: 85.2±23.8 mmHg; p=0.024; mean gradient: no NOAF: 44.4±14.7 mmHg vs NOAF: 53.8±16.8 mmHg; p=0.004). In the multivariable analysis, the baseline mean transaortic gradient was associated with a higher risk of NOAF after TAVI (odds ratio 1.04, 95% confidence interval: 1.01-1.06 for each mmHg; p=0.006). There were no differences between groups in all-cause mortality (no NOAF: 4.7% vs NOAF: 0%; p=0.122), stroke (no NOAF: 1.4% vs NOAF: 2.0%; p=0.723), or bleeding (no NOAF: 1.9% vs NOAF: 4.1%; p=0.288) from the 30-day to 1-year follow-up. CONCLUSIONS: NOAF detected with AECG occurred in 7% of TAVI recipients and was associated with a higher AS severity. NOAF detection determined the start of anticoagulation therapy in about half of the patients, and it was not associated with an increased risk of clinical events at 1-year follow-up.

SYNERGY-Everolimus-Eluting Stent With a Bioabsorbable Polymer in ST-Elevation Myocardial Infarction: CLEAR SYNERGY OASIS-9 Registry.

Our objective was to evaluate the clinical effectiveness of the SYNERGY stent (Boston Scientific Corporation, Marlborough, Massachusetts) in patients with ST-elevation myocardial infarction (STEMI). The only drug-eluting stent approved for treatment of STEMI by the Food and Drug Administration is the Taxus stent (Boston Scientific) which is no longer commercially available, so further data are needed. The CLEAR (Colchicine and spironolactone in patients with myocardial infarction) SYNERGY stent registry was embedded into a larger randomized trial of patients with STEMI (n = 7,000), comparing colchicine versus placebo and spironolactone versus placebo. The primary outcome for the SYNERGY stent registry is major adverse cardiac events (MACE) as defined by cardiovascular death, recurrent MI, or unplanned ischemia-driven target vessel revascularization within 12 months. We estimated a MACE rate of 6.3% at 12 months after primary percutaneous coronary intervention for STEMI based on the Thrombectomy vs percutaneous coronary intervention alone in STEMI (TOTAL) trial. Success was defined as upper bound of confidence interval (CI) to be less than the performance goal of 9.45%. Overall, 733 patients were enrolled from 8 countries with a mean age 60 years, 19.4% diabetes mellitus, 41.3% anterior MI, and median door-to-balloon time of 72 minutes. The MACE rate was 4.8% (95% CI 3.2 to 6.3%) at 12 months which met the success criteria against performance goal of 9.45%. The rates of cardiovascular death, recurrent MI, or target vessel revascularization were 2.7%, 1.9%, 1.0%, respectively. The rates of acute definite stent thrombosis were 0.3%, subacute 0.4%, late 0.4%, and cumulative stent thrombosis of 1.1% at 12 months. In conclusion, the SYNERGY stent in STEMI performed well and was successful compared with the performance goal based on previous trials.

Rationale and Design of the Randomized Bayesian Multicenter COME-TAVI Trial in Patients With a New Onset Left Bundle Branch Block.

Patients with new-onset left bundle branch block (LBBB) after transcatheter aortic valve implantation (TAVI) are at risk of developing delayed high-degree atrioventricular block. Management of new-onset LBBB post-TAVI remains controversial. In the Comparison of a Clinical Monitoring Strategy Versus Electrophysiology-Guided Algorithmic Approach in Patients With a New LBBB After TAVI (COME-TAVI) trial, consenting patients with new-onset LBBB that persists on day 2 after TAVI, meeting exclusion/inclusion criteria, are randomized to an electrophysiological study (EPS)-guided approach or 30-day electrocardiographic monitoring. In the EPS-guided approach, patients with a His to ventricle (HV) interval ≥ 65 ms undergo permanent pacemaker implantation. Patients randomized to noninvasive monitoring receive a wearable continuous electrocardiographic recording and transmitting device for 30 days. Follow-up will be performed at 3, 6, and 12 months. The primary endpoint is a composite outcome designed to capture net clinical benefit. The endpoint incorporates major consequences of both strategies in patients with new-onset LBBB after TAVI, as follows: (i) sudden cardiac death; (ii) syncope; (iii) atrioventricular conduction disorder requiring a pacemaker (for a class I or IIa indication); and (iv) complications related to the pacemaker or EPS. The trial incorporates a Bayesian design with a noninformative prior, outcome-adaptive randomization (initially 1:1), and 2 prespecified interim analyses once 25% and 50% of the anticipated number of primary endpoints are reached. The trial is event-driven, with an anticipated upper limit of 452 patients required to reach 77 primary outcome events over 12 months of follow-up. In summary, the aim of this Bayesian multicentre randomized trial is to compare 2 management strategies in patients with new-onset LBBB post-TAVI-an EPS-guided approach vs noninvasive 30-day monitoring. Trial registration number: NCT03303612.

Les patients chez qui un bloc de branche gauche (BBG) est récemment apparu à la suite de l'implantation valvulaire aortique par cathéter (IVAC) présentent un risque de bloc auriculoventriculaire de haut degré tardif. La prise en charge d'un BBG récemment apparu après une IVAC demeure controversée. Dans le cadre de l'essai COME-TAVI (Comparison of a ClinicalMonitoring Strategy VersusElectrophysiology-Guided Algorithmic Approach in Patients With a New LBBB AfterTAVI, ou comparaison d'une stratégie de surveillance clinique, par rapport à une approche guidée par étude électrophysiologique et fondée sur un algorithme, chez des patients présentant un BBG d'apparition récente à la suite d'une IVAC), des patients qui présentent un BBG d'apparition récente persistant le 2e jour après une IVAC, qui répondent aux critères d'admissibilité et qui ont donné leur consentement sont répartis aléatoirement pour être suivis à l'aide d'une approche guidée par une étude électrophysiologique (EEP) ou faire l'objet d'une surveillance électrocardiographique d'une durée de 30 jours. Un stimulateur cardiaque est implanté chez les patients du groupe de l'EEP dont l'intervalle HV (temps de conduction dans le tronc du faisceau de His jusqu'aux ventricules) est ≥ 65 ms. Les patients du groupe de surveillance non invasive reçoivent un dispositif portable d'enregistrement et de transmission continue de données électrocardiographiques pour une période de 30 jours. Le suivi sera réalisé aux 3e, 6e et 12e mois. Le critère d'évaluation principal est un paramètre composite conçu afin de saisir le bienfait clinique net. Il comprend les conséquences majeures des deux stratégies chez les patients présentant un BBG d'apparition récente après une IVAC, comme suit : (i) mort subite d'origine cardiaque; (ii) syncope; (iii) trouble de la conduction auriculoventriculaire nécessitant la pose d'un stimulateur cardiaque (pour une indication de classe I ou IIa); et (iv) complications relatives au stimulateur cardiaque ou à l'EEP. L'essai intègre une conception bayésienne avec une répartition aléatoire (dans un rapport initial de 1:1) antérieure non informative adaptée aux résultats et deux analyses intermédiaires définies au préalable lorsque 25 % et 50 % du nombre anticipé des critères d'évaluation principaux seront atteints. L'essai est axé sur les événements, et la limite supérieure anticipée pour atteindre 77 événements relatifs aux critères d'évaluation principaux sur 12 mois de suivi est de 452 patients. En résumé, l'objectif de cet essai bayésien multicentrique à répartition aléatoire est de comparer deux stratégies de prise en charge de patients présentant un BBG d'apparition récente après une IVAC, soit une approche guidée par une EEP, par rapport à une surveillance non invasive de 30 jours. Trial registration number: NCT03303612.

No-reflow after primary percutaneous coronary intervention in patients with ST-elevation myocardial infarction: an angiographic core laboratory analysis of the TOTAL Trial.

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.

Ultrasound-guided femoral access in patients with vascular closure devices: a prespecified analysis of the randomised UNIVERSAL trial.

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.

Centralized Triage of Suspected Coronary Artery Disease Using Coronary Computed Tomographic Angiography to Optimize the Diagnostic Yield of Invasive Angiography.

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.

Contexte: La coronarographie par tomodensitométrie (coro-TDM) est préférable à la coronarographie invasive chez les patients sans coronaropathie connue chez qui le diagnostic d'une coronaropathie n'est pas urgent. Méthodologie: Nous avons réalisé une étude interventionnelle non randomisée dans deux centres de soins tertiaires en Ontario. Les patients ambulatoires pour qui une coronarographie invasive non urgente a été demandée entre juillet 2018 et février 2020 ont été recensés par un processus centralisé de triage et se sont fait recommander de subir d'abord une coro-TDM. Les patients qui présentaient une co-ronaropathie obstructive ou dont les résultats se trouvaient tout juste à la limite de ce diagnostic lors de la coro-TDM se faisaient recommander une coronarographie invasive subséquente. L'acceptabilité de l'intervention, sa fidélité et son efficacité ont été évaluées. Résultats: Au total, 226 patients ont été sélectionnés et 186 ont été jugés admissibles. Parmi ces derniers, 166 ont accepté de subir la coro-TDM recommandée par le médecin (acceptabilité de 89 %). Parmi les patients ayant donné leur consentement, 156 (94 %) se sont d'abord soumis à une coro-TDM, et 43 (28 %) présentaient une coronaropathie obstructive ou des résultats limites selon cet examen. Seulement un patient ne présentant pas de coronaropathie ou présentant une coronaropathie non obstructive à la coro-TDM a été orienté vers une coronarographie invasive subséquente, contrairement au protocole (fidélité de 99 %). En tout, 119 des 156 patients s'étant d'abord soumis à une coro-TDM n'ont pas eu à subir une coronarographie invasive dans les 90 jours suivants (76 % d'entre eux ont potentiellement évité une coronarographie invasive grâce à cette première intervention). Parmi les 36 patients qui ont subi une coronarographie invasive après la coro-TDM, comme le recommandait le protocole, 24 présentaient une coronaropathie obstructive (rendement diagnostique de 66,7 %). Si tous les patients qui ont été orientés vers une coronarographie invasive et qui se sont soumis à cet examen dans l'un ou l'autre des centres entre juillet 2016 et février 2020 (n = 694 avant l'instauration; n = 333 après l'instauration) avaient d'abord passé une coro-TDM, une coronaropathie obstructive aurait été décelée lors de la coronarographie invasive chez 42 patients de plus par tranche de 100 patients (intervalle de confiance à 95 % : 26 à 59). Conclusion: Le recours à un processus de triage centralisé permettant de faire d'abord passer une coro-TDM aux patients ambulatoires dans une situation non urgente qui doivent subir une coronarographie invasive semble être un moyen acceptable et efficace de diagnostiquer la coronaropathie obstructive et d'améliorer l'efficacité dans notre système de santé.

Design and Rationale of Routine UltrasouNd GuIdance for Vascular AccEss foR Cardiac Procedures: A Randomized TriaL (UNIVERSAL).

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 Bleeding Academic Research Consortium (BARC) 2, 3, or 5 bleeding or major vascular complications. Methods: The Ultrasound Guidance for Vascular Access for Cardiac Procedures: A Randomized Trial (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.

Introduction: Par rapport à l'abord radial, la limitation importante de l'abord artériel fémoral lors des interventions au cœur pose un risque accru de complications vasculaires et de saignements. L'abord fémoral guidé par ultrasons (US) peut contribuer à réduire les complications vasculaires majeures et les saignements. Nous avons pour objectif de déterminer si l'utilisation systématique du guidage par US pour l'abord artériel fémoral lors des angiographies ou des interventions coronariennes contribuera à réduire les saignements de type 2, 3 ou 5 selon le B leeding A cademic R esearch C onsortium (BARC) ou les complications vasculaires majeures. Méthodes: L' U ltrasou n d Gu i dance for V ascular Acc e ss fo r Cardiac Procedure s : A Randomized Tria l (UNIVERSAL) est un essai multicentrique, prospectif, ouvert, à répartition aléatoire, réalisé par une évaluation à l'insu des résultats. Les patients subissant une angiographie coronarienne avec ou sans intervention par voie fémorale sous guidage fluoroscopique seront répartis de façon aléatoire 1:1 à l'abord fémoral guidé par US ou sans US. Le principal critère d'évaluation est le critère composite de saignements majeurs de type 2, 3 ou 5 selon les critères du BARC ou de complications vasculaires majeures dans les 30 jours. L'essai est conçu de façon à avoir une puissance de 80 % et un seuil alpha bilatéral de 5 % pour déterminer la réduction du risque relatif de 50 % du critère d'évaluation principal selon un taux d'événements dans le groupe témoin de 14 %. Résultats: Le 29 avril 2022, nous avons terminé le recrutement de 621 patients choisis aléatoirement. Les patients avaient un âge moyen de 71 ans (25,4 % de femmes) et un taux élevé de comorbidités : 45 % avaient déjà subi une intervention coronarienne percutanée, 57 % avaient déjà subi un pontage aorto-coronarien et 18 % avaient une maladie vasculaire périphérique. Conclusions: L'essai UNIVERSAL qui sera l'un des plus vastes essais à répartition aléatoire sur l'abord fémoral guidé par US a le potentiel de faire changer les lignes directrices et de faire augmenter le recours aux US lors des interventions coronariennes dans le monde entier.

Effects of routine early treatment with PCSK9 inhibitors in patients undergoing primary percutaneous coronary intervention for ST-segment elevation myocardial infarction: a randomised, double-blind, sham-controlled trial.

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).

Bespoke valve sizing avoids annular rupture in patients treated with a balloon-expandable transcatheter heart valve.

BACKGROUND: Annular and left ventricular outflow tract (LVOT) calcification increase the risk of annular rupture following transcatheter aortic valve replacement (TAVR). The outcomes of a strategy of routine use of a balloon-expandable valve (BEV) for all patients irrespective of annular or LVOT calcium is unknown. OBJECTIVES: We evaluated the impact of bespoke sizing on annular rupture in patients treated with a BEV. METHODS: All consecutive patients undergoing TAVR at a single centre (February 2020-February 2022) were treated only with a BEV. No other valve design was used. Annular/LVOT calcification was assessed using a standardized grading system. For each annular area, we determined the percentage valve oversizing with nominal deployment. The balloon deployment volume was then adjusted when required (over-/underfilled) to achieve over-sizing of approximately 5% in the presence of annular/LVOT calcium and 5%-10% in the absence of annular/LVOT calcium. Adjusted valve areas were assumed to change proportionately to the change in balloon deployment volume. RESULTS: Among 533 TAVR treated patients, annular/LVOT calcification was present in 166 (31.1%) and moderate or severe in 90 (16.9%). In patients with annular/LVOT calcification, the adjusted oversizing was 3.5 ± 3.6% and in patients without annular/LVOT calcification, the adjusted oversizing was 6.8 ± 4.7% (p < 0.001). There were no cases of annular rupture and no cases with more than mild paravalvular leak (PVL). Mild PVL was more frequent in patients with annular/LVOT calcium (10.8% vs 4.6%, p = 0.01). CONCLUSION: Bespoke BEV sizing by adjustment of balloon deployment volume avoided annular rupture in patients undergoing TAVR.

Routine Ultrasonography Guidance for Femoral Vascular Access for Cardiac Procedures: The UNIVERSAL Randomized Clinical Trial.

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.

Length of initial prescription at hospital discharge and long-term medication adherence for elderly, post-myocardial infarction patients: a population-based interrupted time series study.

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/ .

Remote ECG monitoring to reduce complications following transcatheter aortic valve implantations: the Redirect TAVI study.

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.

Before the door: Comparing factors affecting symptom onset to first medical contact for STEMI patients between a high and low-middle income country.

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.

A machine learning-based clinical decision support algorithm for reducing unnecessary coronary angiograms.

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.

A Computed Tomography Protocol to Evaluate Coronary Artery Disease Before Transcatheter Aortic Valve Replacement.

BACKGROUND: Transcatheter aortic valve replacement (TAVR) computed tomographic angiography (CTA) images can be used to evaluate coronary artery disease (CAD). METHODS: We conducted a prospective cohort study of consecutive TAVR patients from November 2019 to February 2021 to evaluate TAVR CTA assessment of CAD on the rate of pre-TAVR invasive angiography. Patients had CTA first or invasive angiography first at the discretion of their treating physicians. TAVR CTA scans were categorised as normal/mild CAD, single-vessel disease, high risk (multivessel or left main disease), or nondiagnostic in patients without previous coronary artery bypass grafting (CABG) and as low risk or high risk in patients with previous CABG. Invasive angiography was recommended before TAVR for high-risk or nondiagnostic CTA findings. RESULTS: TAVR was performed on 354 patients; CTA first was performed in 273 and invasive angiography first in 81. Among 231 patients without previous CABG who had CTA first, 22.1% (51/231) had pre-TAVR invasive angiography and 1.3% (3/231) had pre-TAVR revascularisation. Normal/mild CAD or single-vessel disease was found on CTA in 174 patients, of whom 0.5% (1/174) had high-risk disease on invasive angiography. Among 42 patients with previous CABG who had CTA first, 14.3% (6/42) had pre-TAVR invasive angiography and 2.4% (1/42) had pre-TAVR revascularisation. CONCLUSION: TAVR CTA CAD evaluation can avoid pre-TAVR invasive angiography in more than 70% of patients while rarely missing high risk findings. A CTA-first strategy to assess CAD should be considered, especially among patients where conservative management of CAD is preferred.

Immigrants, Ethnicity, and Adherence to Secondary Cardiac Prevention Therapy: A Substudy of the ISLAND Trial.

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 Interventions Supporting Long-Term Adherence and Decreasing 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.

CONTEXTE: L'objectif de cette étude était d'évaluer l'adhésion aux traitements recommandés dans les lignes directrices pour la prévention secondaire des maladies cardiaques, selon le statut d'immigrant et l'origine ethnique. MÉTHODOLOGIE: Nous avons effectué une sous-étude rétrospective de l'essai contrôlé à répartition aléatoire ISLAND ( I nterventions S upporting L ong-Term A dherence and D ecreasing Cardiovascular Events). Une cohorte de 1 642 participants a été analysée. Les patients ont été classés en catégories basées sur leur statut autodéclaré d'immigrant (personne née au Canada ou à l'étranger) ou de minorité visible (origine européenne ou minorité visible). En utilisant un modèle de régression logistique, nous avons examiné les corrélations entre ces caractéristiques d'intérêt des patients et l'adhésion des patients au traitement médicamenteux par des statines un an après un infarctus du myocarde (IM) de même que l'utilisation de la réadaptation cardiaque, après ajustements selon l'âge, le sexe et les maladies concomitantes. RÉSULTATS: L'ensemble de données comprenait des données sur les résultats obtenus chez 1 049 (64 %) patients nés au Canada et 593 (36 %) immigrants. De ce nombre, 347 (21 %) s'étaient identifiés comme étant des membres d'une minorité visible. Pour l'adhésion aux statines un an après un IM, nous avons observé une tendance non significative en faveur des participants nés à l'étranger comparativement aux participants nés au Canada (rapport de cotes [RC] = 1,26; intervalle de confiance [IC] à 95 % : 0,91-1,68). Aucune différence significative quant à l'adhésion au traitement par des statines un an après un IM n'a été constatée entre les minorités visibles et les participants d'origine européenne (RC = 1,04; IC à 95 % : 0,72-1,51). Ni le statut d'immigrant (RC = 0,91; IC à 95 % : 0,72-1,15) ni le statut de minorité visible (RC = 0,97; IC à 95 % : 0,73-1,28) n'ont été associés à l'utilisation de la réadaptation cardiaque. CONCLUSIONS: Nos résultats montrent, de façon limitée, que l'adhésion au traitement par des statines un an après un IM est meilleure chez les immigrants qui vivent au Canada depuis plus de dix ans. D'autres recherches sont nécessaires pour améliorer nos connaissances sur les stratégies de prévention secondaire auprès des populations d'immigrants.

Complete Revascularization in Patients Undergoing a Pharmacoinvasive Strategy for ST-Segment-Elevation Myocardial Infarction: Insights From the COMPLETE Trial.

[Figure: see text].

A case of cerebral autosomal dominant arteriopathy with subcortical infarcts and leukoencephalopathy (CADASIL) presenting as post-infectious manifestation of SARS-CoV-2 infection.

White matter hyperintensities (WMHs) lacunar infarcts and cerebral microbleeds are well-established features associated with cerebral autosomal dominant arteriopathy with subcortical infarcts and leukoencephalopathy (CADASIL). Increasing case reports and series recounts a wide array of neurological manifestations of COVID-19 including acute cerebrovascular disease, encephalopathy, encephalitis and demyelination. Recently association between COVID-19 and CADASIL has been identified. We describe an unusual case of CADASIL diagnosed as a possible post-infectious manifestation of COVID-19 patient with imaging features closely resembling post-infectious encephalomyelitis.