Right Ventricular Assist Device with an Oxygenator for the Management of Combined Right Ventricular and Respiratory Failure: A Systematic Review.

BACKGROUND: Severe lung disease frequently presents with both refractory hypoxemia and right ventricular (RV) failure. OxyRVAD is an extra-corporeal membrane oxygenation (ECMO) configuration of RV bypass that also supplements gas exchange. This systematic review summarizes the available literature regarding the use of OxyRVAD in the setting of severe lung disease with associated RV failure. METHODS: PubMed, Embase, and Google Scholar were queried on September 27th, 2023, for articles describing the use of an OxyRVAD configuration. The main outcome of interest was survival to ICU discharge. Data on the duration of OxyRVAD support and device-related complications were also recorded. RESULTS: Of 475 identified articles, 33 were retained for analysis. Twenty-one articles were case reports and 12 were case series representing a total of 103 patients. No article provided a comparison group. Most patients (76.4%) were transitioned to OxyRVAD from another type of mechanical support. OxyRVAD was used as a bridge to transplant or curative surgery in 37.4% and as a bridge to recovery or decision in 62.6%. Thirty-one patients (30.1%) were managed with the dedicated single-access dual-lumen ProtekDuo cannula. Median time on OxyRVAD was twelve days (IQR 8-23) and survival to ICU discharge was 63.9%. Device-related complications were infrequently reported. CONCLUSION: OxyRVAD support is a promising alternative for RV support when gas exchange is compromised with good ICU survival in selected cases. Comparative analyses in patients with RV failure with and without severe lung disease are needed.

Canadian Cardiovascular Society/Canadian Association of Interventional Cardiology 2023 Focused Update of the Guidelines for the Use of Antiplatelet Therapy.

Antiplatelet therapy (APT) is the foundation of treatment and prevention of atherothrombotic events in patients with atherosclerotic cardiovascular disease. Selecting the optimal APT strategies to reduce major adverse cardiovascular events, while balancing bleeding risk, requires ongoing review of clinical trials. Appended, the focused update of the Canadian Cardiovascular Society/Canadian Association of Interventional Cardiology guidelines for the use of APT provides recommendations on the following topics: (1) use of acetylsalicylic acid in primary prevention of atherosclerotic cardiovascular disease; (2) dual APT (DAPT) duration after percutaneous coronary intervention (PCI) in patients at high bleeding risk; (3) potent DAPT (P2Y12 inhibitor) choice in patients who present with an acute coronary syndrome (ACS) and possible DAPT de-escalation strategies after PCI; (4) choice and duration of DAPT in ACS patients who are medically treated without revascularization; (5) pretreatment with DAPT (P2Y12 inhibitor) before elective or nonelective coronary angiography; (6) perioperative and longer-term APT management in patients who require coronary artery bypass grafting surgery; and (7) use of APT in patients with atrial fibrillation who require oral anticoagulation after PCI or medically managed ACS. These recommendations are all on the basis of systematic reviews and meta-analyses conducted as part of the development of these guidelines, provided in the Supplementary Material.

Baseline characteristics of a prospective cohort study of aging and cardiovascular diseases among people living with HIV.

OBJECTIVES: Our objective was to report the baseline characteristics of participants in the Canadian HIV and Aging Cohort Study (CHACS) and present amendments to the initial protocol. METHODS: CHACS is a multi-centred prospective cohort study that was initially set from 2011 to 2016 and will now continue recruitment until 2024. Four additional years of follow-up have been added, and additional outcomes and covariates will be prospectively collected. Frailty will be assessed using a modified version of the Fried's frailty phenotype. The four interrelated aspects of gender-gender roles, gender identity, gender relationships, and institutionalized gender-will be measured using the GENESIS-PRAXY questionnaire. Diet will be assessed using a validated, web-based, self-administered food frequency questionnaire. RESULTS: A total of 1049 participants (77% people living with HIV) were recruited between September 2011 and September 2019. Median age at baseline was 54 years (interquartile range 50-61). Most participants were male (84%) and white (83%). Compared with participants without HIV, those with HIV were more likely to be male; to report lower education levels and incomes; to be more sedentary; to use tobacco, recreational, and prescription drugs; to report a personal history of cardiovascular diseases; and to be frail. CONCLUSIONS: The new assessments added to the CHACS protocol will allow for an even more detailed portrait of the pathways leading to accentuated aging for people living with HIV. Participants in the CHACS cohort display important differences in socio-economic and cardiovascular risk factors according to HIV serostatus. These imbalances must be taken into account for all further inferential analyses.

Complete Revascularization Versus Culprit-Lesion-Only PCI in STEMI Patients With Diabetes and Multivessel Coronary Artery Disease: Results From the COMPLETE Trial.

BACKGROUND: In the COMPLETE trial (Complete Versus Culprit-Only Revascularization to Treat Multivessel Disease After Early PCI for STEMI), a strategy of complete revascularization reduced the risk of major cardiovascular events compared with culprit-lesion-only percutaneous coronary intervention in patients presenting with ST-segment-elevation myocardial infarction (STEMI) and multivessel coronary artery disease. Patients with diabetes have a worse prognosis following STEMI. We evaluated the consistency of the effects of complete revascularization in patients with and without diabetes. METHODS: The COMPLETE trial randomized a strategy of complete revascularization, consisting of angiography-guided percutaneous coronary intervention of all suitable nonculprit lesions, versus a strategy of culprit-lesion-only percutaneous coronary intervention (guideline-directed medical therapy alone). In prespecified analyses, treatment effects were determined in patients with and without diabetes on the first coprimary outcome of cardiovascular death or new myocardial infarction and the second coprimary outcome of cardiovascular death, new myocardial infarction, or ischemia-driven revascularization. Interaction P values were calculated to evaluate whether there was a differential treatment effect in patients with and without diabetes. RESULTS: Of the 4041 patients enrolled in the COMPLETE trial, 787 patients (19.5%) had diabetes. The median HbA1c (glycated hemoglobin) was 7.7% in the diabetes group and 5.7% in the nondiabetes group. Complete revascularization consistently reduced the first coprimary outcome in patients with diabetes (hazard ratio, 0.87 [95% CI, 0.59-1.29]) and without diabetes (hazard ratio, 0.70 [95% CI, 0.55-0.90]), with no evidence of a differential treatment effect (interaction P=0.36). Similarly, for the second coprimary outcome, no differential treatment effect (interaction P=0.27) of complete revascularization was found in patients with diabetes (hazard ratio, 0.61 [95% CI, 0.43-0.87]) and without diabetes (hazard ratio, 0.48 [95% CI, 0.39-0.60]). CONCLUSIONS: Among patients presenting with STEMI and multivessel disease, the benefit of complete revascularization over a culprit-lesion-only percutaneous coronary intervention strategy was consistent regardless of the presence or absence of diabetes.

Fractional Flow Reserve-Guided PCI or Coronary Bypass Surgery for 3-Vessel Coronary Artery Disease: 3-Year Follow-Up of the FAME 3 Trial.

BACKGROUND: Previous studies comparing percutaneous coronary intervention (PCI) with coronary artery bypass grafting (CABG) in patients with multivessel coronary disease not involving the left main have shown significantly lower rates of death, myocardial infarction (MI), or stroke after CABG. These studies did not routinely use current-generation drug-eluting stents or fractional flow reserve (FFR) to guide PCI. METHODS: FAME 3 (Fractional Flow Reserve versus Angiography for Multivessel Evaluation) is an investigator-initiated, multicenter, international, randomized trial involving patients with 3-vessel coronary artery disease (not involving the left main coronary artery) in 48 centers worldwide. Patients were randomly assigned to receive FFR-guided PCI using zotarolimus drug-eluting stents or CABG. The prespecified key secondary end point of the trial reported here is the 3-year incidence of the composite of death, MI, or stroke. RESULTS: A total of 1500 patients were randomized to FFR-guided PCI or CABG. Follow-up was achieved in >96% of patients in both groups. There was no difference in the incidence of the composite of death, MI, or stroke after FFR-guided PCI compared with CABG (12.0% versus 9.2%; hazard ratio [HR], 1.3 [95% CI, 0.98-1.83]; P=0.07). The rates of death (4.1% versus 3.9%; HR, 1.0 [95% CI, 0.6-1.7]; P=0.88) and stroke (1.6% versus 2.0%; HR, 0.8 [95% CI, 0.4-1.7]; P=0.56) were not different. MI occurred more frequently after PCI (7.0% versus 4.2%; HR, 1.7 [95% CI, 1.1-2.7]; P=0.02). CONCLUSIONS: At 3-year follow-up, there was no difference in the incidence of the composite of death, MI, or stroke after FFR-guided PCI with current-generation drug-eluting stents compared with CABG. There was a higher incidence of MI after PCI compared with CABG, with no difference in death or stroke. These results provide contemporary data to allow improved shared decision-making between physicians and patients with 3-vessel coronary artery disease. REGISTRATION: URL: https://www. CLINICALTRIALS: gov; Unique identifier: NCT02100722.

Adherence to Cardiovascular Prevention Guidelines in an Academic Centre.

Background: Adherence to guidelines is associated with better patient outcomes. Although studies show suboptimal adherence to cardiovascular prevention guidelines among general practitioners, adherence among specialist physicians is understudied. The aim of this analysis was to identify practice gaps among cardiologists in a tertiary academic centre. Methods: We retrospectively audited cardiology outpatient clinic notes taken at the Cardiology Clinic at the Centre hospitalier de l'Université de Montréal (CHUM), from the period January 1, 2019 to February 28, 2019. Data were abstracted from hospital medical records. The primary outcome of interest was the rate of adherence to cardiovascular prevention guidelines. We compared the chart-documented practice at our centre to the Canadian hypertension, lipid, diabetes, antiplatelet, and heart failure guidelines in effect at the time of the audit. We also collected information regarding discussions of smoking, alcohol consumption, physical activity, and diet. Results: A total of 2503 patients were included, with a mean age of 65.6 ± 14.5 years. Dyslipidemia occurred in 63% of patients, hypertension in 55%, and coronary artery disease in 41%. Optimal low-density lipoprotein control was documented as having been achieved in just 39% of cases. Blood pressure control was adequate for 65% of patients, and glycemic control was achieved in 47% of patients with diabetes. Heart failure treatment was optimal in 34% of patients. Nearly all patients with coronary artery disease (95%) had appropriate antithrombotic therapy. The incidence of discussion of nonpharmacologic interventions varied, ranging from 91% (smoking) to 16% (diet). Conclusions: Primary and secondary prevention of cardiovascular events was found to be suboptimal in an academic tertiary-care outpatient cardiology clinic and may be representative of similar shortcomings nationwide. Strategies to ensure guideline adherence are needed.

Contexte: Le respect des lignes directrices est associé à de meilleurs résultats pour les patients. Bien que les études montrent que les omnipraticiens adhèrent de façon sous-optimale aux lignes directrices en matière de prévention des événements cardiovasculaires, l'observance chez les médecins spécialistes n'a pas été assez étudiée. Notre analyse a pour objectif de déceler les lacunes dans la pratique des cardiologues exerçant dans des centres universitaires de soins tertiaires. Méthodologie: Nous avons examiné de manière rétrospective les notes cliniques consignées au dossier des patients du Centre cardiovasculaire du Centre hospitalier de l'Université de Montréal (CHUM) et résumé les données issues des consultations ayant eu lieu du 1er janvier au 28 février 2019. Le principal résultat d'intérêt était le taux d'adhésion aux lignes directrices en matière de prévention des événements cardiovasculaires. Nous avons comparé les pratiques enregistrées dans les dossiers de notre centre aux lignes directrices canadiennes sur la prise en charge de l'hypertension, de la lipidémie, du diabète, du traitement antiplaquettaire et de l'insuffisance cardiaque en place au moment de l'évaluation. Nous avons aussi recueilli de l'information sur les discussions entourant le tabagisme, la consommation d'alcool, l'activité physique et l'alimentation. Résultats: Les données de 2 503 patients, âgés en moyenne de 65,6 ± 14,5 ans, ont été retenues. De ces patients, 63 % présentaient une dyslipidémie, 55 %, une hypertension et 41 %, une maladie coronarienne. Le taux de lipoprotéines de basse densité n'était maîtrisé de façon optimale que dans 39 % des cas. La normalisation de la pression artérielle était adéquate chez 65 % des patients, et 47 % des patients diabétiques atteignaient les cibles glycémiques. L'insuffisance cardiaque était optimalement traitée chez 34 % des patients. Presque tous les patients atteints de maladie coronarienne (95 %) recevaient un traitement antithrombotique approprié. La fréquence des discussions sur les interventions non pharmacologiques variait, allant de 91 % dans le cas du tabagisme à 16 % dans celui de l'alimentation. Conclusions: La prévention primaire et secondaire des événements cardiovasculaires s'est révélée sous-optimale dans une clinique externe de cardiologie d'un hôpital universitaire et pourrait être représentative de lacunes similaires dans l'ensemble du pays. Des stratégies visant à assurer le respect des lignes directrices sont nécessaires.

Antithrombotic therapies in Canadian atrial fibrillation patients with concomitant coronary artery disease: Insights from the CONNECT AF + PCI-II program.

BACKGROUND: Selecting the appropriate antithrombotic regimen for patients with atrial fibrillation (AF) who have undergone percutaneous coronary intervention (PCI) or have had medically managed acute coronary syndrome (ACS) remains complex. This multi-centre observational study evaluated patterns of antithrombotic therapies utilized among Canadian patients with AF post-PCI or ACS. METHODS AND RESULTS: By retrospective chart audit, 611 non-valvular AF patients [median (interquartile range) age 76 (69-83) years, CHADS2 score 2 (1-3)] who underwent PCI or had medically managed ACS between August 2018 and December 2020 were identified by 68 cardiologists across eight provinces in Canada. Overall, triple antithrombotic therapy [TAT: combined oral anticoagulation (OAC) and dual antiplatelet therapy (DAPT)] was the most common initial antithrombotic strategy, with use in 53.8 % of patients, followed by dual pathway therapy (32.7 % received OAC and a P2Y12 inhibitor, and 4.1 % received OAC and aspirin) and DAPT (9.3 %). Median duration of TAT was 30 (7, 30) days. Compared to the previous CONNECT AF + PCI-I program, there was an increased use of dual pathway therapy relative to TAT over time (P-value <.0001). DOACs (direct oral anticoagulants) represented 90.3 % of all OACs used overall, with apixaban being the most utilized (50.5 %). Proton pump inhibitors were used in 57.0 % of all patients, and 70.1 % of patients on ASA. Planned antithrombotic therapies at 1 year were: 76.2 % OAC monotherapy, 8.3 % OAC + ASA, 7.9 % OAC + P2Y12 inhibitor, 4.3 % DAPT, 1.3 % ASA alone, and <1 % triple therapy. CONCLUSION: In accordance with recent Canadian Cardiovascular Society guideline recommendations, we observed an increased use of dual pathway therapy relative to TAT over time in both AF patients post-PCI (elective and emergent) and in those with medically managed ACS. Additionally, DOACs have become the prevailing form of anticoagulation across all antithrombotic regimens. Our findings suggest that Canadian physicians are integrating evidence-based approaches to optimally manage the bleeding and thrombotic risks of AF patients post-PCI and/or ACS.

Anterolateral territory coronary artery bypass grafting strategies: a non-inferiority randomized clinical trial: the AMI-PONT trial.

OBJECTIVES: The main objective was to assess whether a composite coronary artery bypass grafting strategy including a saphenous vein graft bridge to distribute left internal mammary artery outflow provides non-inferior patency rates compared to conventional grafting surgery with separated left internal mammary artery to left anterior descending coronary graft and aorto-coronary saphenous vein grafts to other anterolateral targets. METHODS: All patients underwent isolated grafting surgery with cardiopulmonary bypass and received ≥2 grafts/patients on the anterolateral territory. The graft patency (i.e. non-occluded) was assessed using multislice spiral computed tomography at 1 year. RESULTS: From 2012 to 2021, 208 patients were randomized to a bridge (n = 105) or conventional grafting strategy (n = 103). Patient characteristics were comparable between groups. The anterolateral graft patency was non-inferior in the composite bridge compared to conventional grafting strategy at 1 year [risk difference 0.7% (90% confidence interval -4.8 to 6.2%)]. The graft patency to the left anterior descending coronary was no different between groups (P = 0.175). Intraoperatively, the bridge group required shorter vein length for anterolateral targets (P < 0.001) and exhibited greater Doppler flow in the mammary artery pedicle (P = 0.004). The composite outcome of death, myocardial infarction or target vessel reintervention at 30 days was no different (P = 0.164). CONCLUSIONS: Anterolateral graft patency of the composite bridge grafting strategy is non-inferior to the conventional grafting strategy at 1 year. This novel grafting strategy is safe, efficient, associated with several advantages including better mammary artery flow and shorter vein requirement, and could be a valuable alternative to conventional grafting strategies. Ten-year clinical follow-up is underway. TRIAL REGISTRATION: ClinicalTrials.gov: NCT01585285.

Coronary bioresorbable stents: Non-invasive quantitative evaluation of intra- and juxta-stent plaque composition-A computed tomography longitudinal study.

PURPOSE: Coronary bioresorbable stents (BRS) do not produce blooming artifacts on computed tomography (CT), in contrast to metallic stents, as they are made of a bioresorbable polymer and are radiolucent. They allow to evaluate the coronary plaque beneath. The low-attenuation plaque (LAP) suggests plaque vulnerability and is CT assessable. The aim of our study was to show the possibility of a non-invasive CT evaluation of the volume and the LAP composition of the intra- and juxta-stent plaque. METHODOLOGY: In our prospective longitudinal study, we recruited 27 consecutive patients (35 BRS stents total; mean age 60 +/- 9 years) with bioresorbable stents for a 256-slice ECG-synchronized CT evaluation at 1- and 12-months post stent implantation. Total plaque volume (mm3), absolute and relative (%) LAP volume per block in the pre- intra- and post-stent zones were analyzed; comparison 1- and 12-months post-implantation of BRS. Changes in the previously mentioned variables were assessed by the mixed effects models with and without spline, which also accounted for the correlation between repeated measurements. RESULTS: Our block or spline model analysis has shown no significant difference in plaque or absolute LAP volumes in pre- intra- and post-stent zones between 1 and 12 months. Interestingly, % LAP volume increases near-significantly in the distal block of the intrastent at 12-mo follow-up (from 23.38 ± 1.80% to 26.90 ± 2.22% (increase of 15%), p = 0.052). CONCLUSION: Our study demonstrates the feasibility of the repeated non-invasive quantitative analysis of the intrastent coronary plaque and of the in-stent lumen by CT scan.

Prevalence of H. pylori among patients undergoing coronary angiography (The HP-DAPT prevalence study).

Helicobacter pylori (H. pylori) screening and treatment is recommended for patients on chronic aspirin (ASA) therapy to reduce the risk of gastrointestinal bleeding. Coronary artery disease patients requiring combination antithrombotic therapy (dual antiplatelet therapy; DAPT, or dual pathway inhibition; DPI) are at an even higher risk of GI bleeding. Therefore, we aimed to evaluate the prevalence of H. pylori among patients referred for angiography and likely to receive DAPT or DPI. This single-center prospective observational study recruited patients undergoing coronary angiography and with the possibility of requiring DAPT or DPI. All included patients underwent H. pylori serology testing. Multivariable logistic regression was performed to determine predictors of seropositivity. 195 patients were included in the analysis. Mean age was 67 years, 50% had known prior CAD, and 49% underwent coronary intervention. H. pylori serology was positive in 36%. Chronic kidney disease (odds ratio [OR] 2.76; 95% confidence interval [CI] 1.24 to 6.15; p = 0.01) and chronic obstructive pulmonary disease (OR 2.52; 95% CI 1.14 to 5.55; p = 0.02) history were independent predictors of H. pylori seropositivity. Given the clinically significant prevalence of H. pylori seropositivity among patients referred for angiography, systematic screening strategies and eradication of H. pylori could significantly reduce the incidence of GI bleeding in patients requiring DAPT or DPI.

Prehospital STEMI Referral Systems and Sex-Related Bias in Canada: A National Survey.

Background: Prehospital electrocardiographic ST-elevation myocardial infarction (STEMI) diagnosis and prehospital cardiac catheterization laboratory activation have been shown to significantly reduce average treatment delay, and further standardization of such systems may help reduce sex-related treatment and outcome gaps. However, what types of prehospital STEMI activation systems are in place across Canada, and to what extent sex-based STEMI treatment disparities are tracked, is unknown. Methods: We conducted a national survey of catheterization laboratory directors between October 11 and December 25, 2021. Seventeen catheterization laboratory directors representing 6 community and 11 academic centres completed the survey (40% response rate). Results: : All responding centres use a prehospital STEMI diagnosis and cardiac catheterization laboratory activation system, and the majority (59%) rely on real-time physician oversight. Slightly less than half (47%) of percutaneous coronary intervention centres reported prospectively tracking sex-related differences in STEMI care, and only one respondent believed that a significant systemic sex-related bias was present in their prehospital STEMI referral system. Patient factors (symptom description or time to presentation; 23.5%) and limitations of electrocardiogram diagnosis of STEMI in women (23.5%) were cited most frequently as contributing to sex-related bias in STEMI referral systems. In contrast, implicit bias in the referral algorithm, prehospital provider bias, and physician bias were not considered important contributing factors. Conclusions: Although all responding centres employ prehospital activation systems, less than half tracked sex-related differences, and most respondents believed that no sex-related bias existed in their prehospital STEMI system.

Contexte: Il a été démontré que le diagnostic préhospitalier par électrocardiogramme de l'infarctus du myocarde avec élévation du segment ST (STEMI) et l'activation du laboratoire de cathétérisme cardiaque préhospitalier permettent de réduire significativement le délai moyen de traitement, et un usage plus standardisé de ces systèmes pourrait contribuer à la réduction des écarts liés au sexe dans les traitements et les résultats de santé. Toutefois, on ignore quels types de systèmes d'activation préhospitaliers pour la prise en charge du STEMI sont en place à travers le Canada, ni dans quelle mesure les disparités de traitement liées au sexe font l'objet d'un suivi. Méthodologie: Nous avons mené un sondage national auprès des directeurs de laboratoires de cathétérisme entre le 11 octobre et le 25 décembre 2021. Notre questionnaire a été rempli par les directeurs de 17 laboratoires de cathétérisme, dont six centres communautaires et 11 centres universitaires (taux de réponse de 40 %). Résultats: Pour tous les centres répondants, un système de diagnostic préhospitalier du STEMI et d'activation de laboratoire de cathétérisme cardiaque était en place, dont la surveillance était assurée majoritairement par un médecin en temps réel (59 %). Un peu moins de la moitié des centres d'intervention coronarienne percutanée (47 %) ont rapporté faire un suivi prospectif des différences liées au sexe dans la prise en charge du STEMI, et un seul répondant a dit croire qu'un biais systématique lié au sexe était présent dans le système d'orientation préhospitalier pour les STEMI. Les facteurs liés aux patients (la description des symptômes ou le temps écoulé depuis leur apparition; 23,5 %) et les limites inhérentes au diagnostic du STEMI par électrocardiogramme chez les femmes (23,5 %) étaient les facteurs les plus fréquemment mentionnés comme sources de biais liés au sexe dans les systèmes d'orientation pour les STEMI. Par ailleurs, les biais implicites dans l'algorithme d'orientation et les biais des prestataires de soins préhospitaliers et des médecins n'étaient pas des facteurs contributifs jugés importants. Conclusions: Bien que des systèmes d'activation préhospitaliers soient en place dans tous les centres répondants, moins de la moitié d'entre eux ont rapporté faire le suivi des différences liées au sexe, et la plupart des répondants étaient d'avis que leur système préhospitalier de prise en charge des STEMI ne comportait pas de biais liés au sexe.

Percutaneous Mechanical Circulatory Support in Post-Myocardial Infarction Cardiogenic Shock: A Systematic Review and Meta-analysis.

BACKGROUND: Cardiogenic shock (CS) complicates 5%-10% of acute myocardial infarction (AMI) and is the leading cause of early mortality. It remains unclear whether percutaneous mechanical support (pMCS) devices improve post-AMI CS outcome. METHODS: A systematic review of original studies comparing the effect of pMCS on AMI-CS mortality was conducted with the use of Medline, Embase, Google Scholar, and the Cochrane Library databases. RESULTS: Of 8672 records, 50 were retained for quantitative analysis. Four additional references were added from other sources. Four references reported a significant mortality reduction with intra-aortic balloon pump (IABP) in patients with failed primary percutaneous coronary intervention (pPCI) or managed with thrombolysis. Meta-analyses showed no advantage of Impella over conventional therapy (pooled OR 0.55, 95% CI 0.20-1.46; I2 = 0.85) and increased mortality compared with IABP (pooled OR 1.32; 95% CI 1.08-1.62; I2 = 0.85). No study reported a mortality advantage for extracorporeal membrane oxygenation (ECMO) over conventional therapy, IABP, or Impella support. Early mortality might be improved with the addition of IABP or Impella to ECMO. Bleeding Academic Research Consortium ≥ 3 bleeding was increased with every pMCS strategy. CONCLUSIONS: The current evidence is of poor to moderate quality, with only 1 in 5 included articles reporting randomised data and several reporting unadjusted outcomes. Yet, there is some evidence to favour IABP use in the setting of thrombolysis or with failed pPCI, and adding IABP or Impella should be considered for patients requiring ECMO.

Surgical Triage and Timing for Patients With Coronavirus Disease: A Guidance Statement from The Society of Thoracic Surgeons.

The coronavirus disease 2019 (COVID-19) pandemic continues to disrupt the provision of cardiac procedural services due to overwhelming interval surges in COVID-19 cases and the associated crisis of cardiac intervention deferment. Despite the availability of widespread testing, highly efficacious vaccines, and intensive public health efforts, the pandemic is entering its third year, where new severe acute respiratory syndrome-coronavirus-2 variants have increased the likelihood that patients scheduled for a cardiac intervention will contract COVID-19 in the perioperative period. The Society of Thoracic Surgeons (STS) Workforce on Critical Care, the STS Workforce on Adult Cardiac and Vascular Surgery, and the Canadian Society of Cardiac Surgeons have developed this document, endorsed by the STS and affirmed by the Society of Cardiovascular Angiography and Interventions and the Canadian Association of Interventional Cardiology, to provide guidance for cardiac procedure deferment and intervention timing for preoperative patients diagnosed with COVID-19. This document is intended for the perioperative cardiac surgical team and outlines the present state of the pandemic, the impact of COVID-19 on intervention outcome, and offers a recommended algorithm for individualized cardiac procedure triage and timing.

Quality of Life After Fractional Flow Reserve-Guided PCI Compared With Coronary Bypass Surgery.

BACKGROUND: Previous studies have shown that quality of life improves after coronary revascularization more so after coronary artery bypass grafting (CABG) than after percutaneous coronary intervention (PCI). This study aimed to evaluate the effect of fractional flow reserve guidance and current generation, zotarolimus drug-eluting stents on quality of life after PCI compared with CABG. METHODS: The FAME 3 trial (Fractional Flow Reserve Versus Angiography for Multivessel Evaluation) is a multicenter, international trial including 1500 patients with 3-vessel coronary artery disease who were randomly assigned to either CABG or fractional flow reserve-guided PCI. Quality of life was measured using the European Quality of Life-5 Dimensions (EQ-5D) questionnaire at baseline and 1 and 12 months. The Canadian Cardiovascular Class angina grade and working status were assessed at the same time points and at 6 months. The primary objective was to compare EQ-5D summary index at 12 months. Secondary end points included angina grade and work status. RESULTS: The EQ-5D summary index at 12 months did not differ between the PCI and CABG groups (difference, 0.001 [95% CI, -0.016 to 0.017]; P=0.946). The trajectory of EQ-5D during the 12 months differed (P<0.001) between PCI and CABG: at 1 month, EQ-5D was 0.063 (95% CI, 0.047 to 0.079) higher in the PCI group. A similar trajectory was found for the EQ (EuroQol) visual analogue scale. The proportion of patients with Canadian Cardiovascular Class 2 or greater angina at 12 months was 6.2% versus 3.1% (odds ratio, 2.5 [95% CI, 0.96-6.8]), respectively, in the PCI group compared with the CABG group. A greater percentage of younger patients (<65 years old) were working at 12 months in the PCI group compared with the CABG group (68% versus 57%; odds ratio, 3.9 [95% CI, 1.7-8.8]). CONCLUSIONS: In the FAME 3 trial, quality of life after fractional flow reserve-guided PCI with current generation drug-eluting stents compared with CABG was similar at 1 year. The rate of significant angina was low in both groups and not significantly different. The trajectory of improvement in quality of life was significantly better after PCI, as was working status in those <65 years old. REGISTRATION: URL: https://www. CLINICALTRIALS: gov; Unique identifier: NCT02100722.

Double-blind, placebo-controlled evaluation of biorest liposomal alendronate in diabetic patients undergoing PCI: The BLADE-PCI trial.

BACKGROUND: Diabetes mellitus (DM) is an important predictor of neointimal hyperplasia (NIH) and adverse clinical outcomes after percutaneous coronary intervention (PCI). LABR-312, a novel intravenous formulation of liposomal alendronate, has been shown in animal models to decrease NIH at vascular injury sites and around stent struts. The aim of the Biorest Liposomal Alendronate Administration for Diabetic Patients Undergoing Drug-Eluting Stent Percutaneous Coronary Intervention trial was to assess the safety, effectiveness, and dose response of LABR-312 administered intravenously at the time of PCI withDES in reducing NIH as measured by optical coherence tomography postprocedure in patients with DM. METHODS: Patients with DM were randomized to a bolus infusion of LABR-312 vs placebo at the time of PCI. Dose escalation of LABR-312 in the study arm was given: 0.01 mg, 0.03 mg, and 0.08 mg. The primary endpoint was the in-stent %NIH volume at 9 months as measured by optical coherence tomography. RESULTS: From September 2016 to December 2017, 271 patients with DM undergoing PCI were enrolled; 136 patients were randomized to LABR-312 infusion and 135 patients were randomized to placebo. At 9-month follow-up, no difference was seen in the primary endpoint of %NIH between LABR-312 and placebo (13.3% ± 9.2 vs 14.6% ± 8.5, P = .35). No differences were present with the varying LABR-312 doses. Clinical outcomes at 9 months were similar between groups. CONCLUSIONS: Among patients with DM undergoing PCI with drug-eluting stents, a bolus of LABR-312 injected systematically at the time of intervention did not result in a lower rate in-stent %NIH volume at 9-month follow-up.

Collagenase to facilitate guidewire crossing in chronic total occlusion PCI-The Total Occlusion Study in Coronary Arteries-5 (TOSCA-5) trial.

BACKGROUND: Chronic total occlusions (CTO) are common and are associated with lower percutaneous coronary intervention (PCI) success rates, often due to failure of antegrade guidewire crossing. Local, intralesional delivery of collagenase (MZ-004) may facilitate guidewire crossing in CTO. AIMS: To evaluate the effect of MZ-004 in facilitating antegrade wire crossing in CTO angioplasty. METHODS: A total of 76 patients undergoing CTO PCI were enrolled at 13 international sites: 38 in the randomized training stage (collagenase [MZ-004] 900 or 1200 µg) and 38 in the placebo-controlled stage (MZ-004 900 or 1200 µg or placebo). Patients received the MZ-004 or identical volume saline (placebo group) in a double-blind design, injected via microcatheter directly into the proximal cap of the CTO. The following day patients underwent CTO PCI using antegrade wire techniques only. RESULTS: Patients were generally similar except for a trend for higher Japanese chronic total occlusion (J-CTO) score in the MZ-004 group (MZ-004 J-CTO score 1.9 vs. 1.4, p = 0.07). There was a numerical increase in the rates of guidewire crossing in the MZ-004 groups compared to placebo (74% vs. 63%, p = 0.52). Guidewire crossing with a soft-tip guidewire (≤1.5 g tip load) was significantly higher in the MZ-004 groups (0% in placebo, 17% in 900 µg, and 29% in 1200 µg MZ-004 group, p = 0.03). Rates of the major adverse cardiovascular event were similar between groups. CONCLUSION: Local delivery of MZ-004 into coronary CTOs appears safe and may facilitate CTO crossing, particularly with softer tipped guidewires. These data support the development of a pivotal trial to further evaluate this agent.

Fractional Flow Reserve-Guided PCI as Compared with Coronary Bypass Surgery.

BACKGROUND: Patients with three-vessel coronary artery disease have been found to have better outcomes with coronary-artery bypass grafting (CABG) than with percutaneous coronary intervention (PCI), but studies in which PCI is guided by measurement of fractional flow reserve (FFR) have been lacking. METHODS: In this multicenter, international, noninferiority trial, patients with three-vessel coronary artery disease were randomly assigned to undergo CABG or FFR-guided PCI with current-generation zotarolimus-eluting stents. The primary end point was the occurrence within 1 year of a major adverse cardiac or cerebrovascular event, defined as death from any cause, myocardial infarction, stroke, or repeat revascularization. Noninferiority of FFR-guided PCI to CABG was prespecified as an upper boundary of less than 1.65 for the 95% confidence interval of the hazard ratio. Secondary end points included a composite of death, myocardial infarction, or stroke; safety was also assessed. RESULTS: A total of 1500 patients underwent randomization at 48 centers. Patients assigned to undergo PCI received a mean (±SD) of 3.7±1.9 stents, and those assigned to undergo CABG received 3.4±1.0 distal anastomoses. The 1-year incidence of the composite primary end point was 10.6% among patients randomly assigned to undergo FFR-guided PCI and 6.9% among those assigned to undergo CABG (hazard ratio, 1.5; 95% confidence interval [CI], 1.1 to 2.2), findings that were not consistent with noninferiority of FFR-guided PCI (P = 0.35 for noninferiority). The incidence of death, myocardial infarction, or stroke was 7.3% in the FFR-guided PCI group and 5.2% in the CABG group (hazard ratio, 1.4; 95% CI, 0.9 to 2.1). The incidences of major bleeding, arrhythmia, and acute kidney injury were higher in the CABG group than in the FFR-guided PCI group. CONCLUSIONS: In patients with three-vessel coronary artery disease, FFR-guided PCI was not found to be noninferior to CABG with respect to the incidence of a composite of death, myocardial infarction, stroke, or repeat revascularization at 1 year. (Funded by Medtronic and Abbott Vascular; FAME 3 ClinicalTrials.gov number, NCT02100722.).

Assessing the Accuracy of a Second-Generation Optical Sensor Pressure Wire in a Wire-to-Wire Comparison (The ACCURACY Study).

BACKGROUND: The phenomenon of "pressure drift" increases uncertainty about the correct FFR value. Redesigned and incorporating an optical pressure sensor, the "OptoWire Deux™" is purported to be less prone to the pressure drift seen with piezoelectric coronary pressure wires. The aim of this first in vivo real-world clinical study is to evaluate the performance of OptoWire Deux™ in terms of measurements agreement and propensity to pressure drift in a wire to wire comparison. METHODS: This is a single center, prospective, non-blinded clinical investigation enrolling 45 consecutive patients with a clinical indication for coronary lesion FFR assessment. Lesions were either simultaneously assessed with two optical sensor pressure wires (OSPW) (Group O-O; 30 patients, 34 lesions) or one OSPW and one piezoelectric pressure wire (PEPW) simultaneously (Group O-P; 15 patients, 15 lesions). Significant drift was defined as a pressure ratio deviation of >0.03. RESULTS: Mean FFR measurements in Group OO were not statistically different between the two sets of OSPW (overall 0.84±0.10; P = 0.52). In Group OP, however, mean FFR measurement with PEPW (0.85±0.09) was numerically lower than that observed with the OSPW (0.88±0.08; P = 0.09). Level of agreement using the Bland-Altman method was higher when 2 OSPW were used for FFR assessment (-0.002 95% CI [-0.033,0.029] vs. 0.026 95% CI [-0.078, 0.130], respectively). The rate of drift was significantly lower with an OSPW compared to a PEPW (4.8% vs. 26.7% respectively, P = 0.02). CONCLUSION: The optical sensor guidewire showed a high level of readings' agreement after simultaneous usage of 2 optical sensor guidewires. There was also significantly less drift when compared to a piezoelectric guidewire.

White blood cell count and clinical outcomes after left main coronary artery revascularization: insights from the EXCEL trial.

BACKGROUND: Prior studies have reported an association between elevated white blood cell count (WBCc) and worse clinical outcomes after coronary artery bypass grafting (CABG) and percutaneous coronary intervention (PCI). We assessed the prognostic impact of WBCc in patients undergoing revascularization for left main coronary artery disease (LMCAD). METHODS: In Evaluation of XIENCE Versus Coronary Artery Bypass Surgery for Effectiveness of Left Main Revascularization (EXCEL), 1905 patients with LMCAD and low or intermediate SYNTAX scores were randomized to PCI with everolimus-eluting stents versus CABG. The 1895 patients with baseline WBCc available were grouped in tertiles of WBCc (mean 5.6 ± 0.8, 7.5 ± 0.5, and 10.1 ± 1.6 × 109/L). RESULTS: Five-year rates of the primary endpoint (death, myocardial infarction or stroke) were similar across increasing WBCc tertiles (21.2, 18.9, and 21.6%; P = 0.46). Individual components of the primary endpoint, Bleeding Academic Research Consortium (BARC) 3-5 bleeding, stent thrombosis or graft occlusion and ischemia-driven revascularization were all similar across WBCc tertiles. By multivariable analysis, WBCc as a continuous variable was not an independent predictor of adverse events (hazard radio per 1 × 109/L: 1.02; 95% CI, 0.97-1.08; P = 0.43). Results were consistent in the PCI and CABG arms individually. CONCLUSION: There was no association between baseline WBCc and 30-day or 5-year clinical outcomes after PCI or CABG. The absence of a clear incremental increase in events with increasing WBCc in the current analysis indicates that WBCc should not routinely be used as a prognostic marker or to guide revascularization decisions in patients with LMCAD.