Milrinone as Compared with Dobutamine in the Treatment of Cardiogenic Shock.

BACKGROUND: Cardiogenic shock is associated with substantial morbidity and mortality. Although inotropic support is a mainstay of medical therapy for cardiogenic shock, little evidence exists to guide the selection of inotropic agents in clinical practice. METHODS: We randomly assigned patients with cardiogenic shock to receive milrinone or dobutamine in a double-blind fashion. The primary outcome was a composite of in-hospital death from any cause, resuscitated cardiac arrest, receipt of a cardiac transplant or mechanical circulatory support, nonfatal myocardial infarction, transient ischemic attack or stroke diagnosed by a neurologist, or initiation of renal replacement therapy. Secondary outcomes included the individual components of the primary composite outcome. RESULTS: A total of 192 participants (96 in each group) were enrolled. The treatment groups did not differ significantly with respect to the primary outcome; a primary outcome event occurred in 47 participants (49%) in the milrinone group and in 52 participants (54%) in the dobutamine group (relative risk, 0.90; 95% confidence interval [CI], 0.69 to 1.19; P = 0.47). There were also no significant differences between the groups with respect to secondary outcomes, including in-hospital death (37% and 43% of the participants, respectively; relative risk, 0.85; 95% CI, 0.60 to 1.21), resuscitated cardiac arrest (7% and 9%; hazard ratio, 0.78; 95% CI, 0.29 to 2.07), receipt of mechanical circulatory support (12% and 15%; hazard ratio, 0.78; 95% CI, 0.36 to 1.71), or initiation of renal replacement therapy (22% and 17%; hazard ratio, 1.39; 95% CI, 0.73 to 2.67). CONCLUSIONS: In patients with cardiogenic shock, no significant difference between milrinone and dobutamine was found with respect to the primary composite outcome or important secondary outcomes. (Funded by the Innovation Fund of the Alternative Funding Plan for the Academic Health Sciences Centres of Ontario; ClinicalTrials.gov number, NCT03207165.).

Transcatheter mitral valve repair for inotrope dependent cardiogenic shock - Design and rationale of the CAPITAL MINOS trial.

BACKGROUND: Functional mitral regurgitation (MR) is an important clinical consideration in patients with heart failure. Transcatheter edge-to-edge repair (TEER) has emerged as a useful therapeutic tool for patients with chronic heart failure, however the role of TEER in patients with cardiogenic shock (CS) and MR has not yet been studied in a randomized trial. The Transcatheter Mitral Valve Repair for Inotrope Dependent Cardiogenic Shock (CAPITAL MINOS) trial was therefore designed to determine if TEER improves clinical outcomes in the CS population. METHODS AND DESIGN: The CAPITAL MINOS trial is an open-label, multi-center randomized clinical trial comparing TEER to medical therapy in patients with CS and MR. A total of 144 patients with Society for Cardiovascular Angiography and Interventions (SCAI) class C or D CS and at least 3+ MR will be randomized in a 1:1 ratio to TEER or medical therapy alone. The primary outcome will be a composite of in-hospital all-cause mortality, cardiac transplantation, implantation of durable left ventricular assist device, or discharge on palliative inotropic therapy. Patients will be followed for the duration of their index hospitalization for the primary outcome. Secondary outcomes include 6 month mortality. IMPLICATIONS: The CAPITAL MINOS trial will determine whether TEER improves outcomes in patients with CS and MR and will be an important step in optimizing treatment for this high-risk patient population.

Impact of intracoronary assessments on revascularization decisions: A contemporary evaluation.

OBJECTIVES: To investigate the real-world implementation of intracoronary assessment (ICA) techniques and evaluate their impact on clinical decisions regarding the management of coronary artery disease (CAD) in contemporary practice. BACKGROUND: Coronary angiogram is the gold standard used to diagnose vessel stenosis and guide percutaneous coronary intervention (PCI); however, it is limited by its two-dimensional imaging capabilities. ICA techniques like intravascular ultrasound and optical coherence tomography capture the vessel in three-dimensional images. Comparatively, fractional flow reserve provides information on the physiologic significance of coronary stenosis. Both techniques may improve PCI outcomes if they routinely change physician behavior. METHODS: Patients who underwent ICA between August 2015 and March 2020 were included in the study. The primary outcome was the clinical impact of ICA on physician clinical decision making of a stenotic vessel. The secondary outcome was the clinical changes that occurred following ICA. RESULTS: A total of 1135 patients were included in the study. Physiologic assessment (PA) and image assessment (IA) were performed in 61.4% and 38.6% respectively. Management plans were changed in 38.1% and 23.9% of patients who received PA and IA. Over half of the management change resulted in physicians deciding to not intervene on the stenotic vessel. One-year outcome of these decisions showed no significant increase in major adverse cardiac events (hazard ratio [HR], 0.68; 95% confidence interval [CI], 0.40-1.15; p = 0.15) or unplanned revascularization (HR, 0.78; 95% CI, 0.35-1.74; p = 0.55) suggesting reliance on PA/IA data did not increase risk. CONCLUSION: Selected ICA alters physician management of CAD in one-third of patients being evaluated for revascularization-typically leading to fewer interventions. All cause death is numerally lower in patients that received a change in management. However, the 1-year outcome of these altered decisions does not appear to be significantly different.

Transcatheter edge-to-edge repair in patients with mitral regurgitation and cardiogenic shock: a new therapeutic target.

PURPOSE OF REVIEW: Cardiogenic shock with significant mitral regurgitation portends a poor prognosis with limited therapeutic options. Herein, we review the available evidence regarding the patient characteristics, management, impact of transcatheter edge-to-edge repair (TEER) on hemodynamics, and clinical outcomes of patients with cardiogenic shock and mitral regurgitation. RECENT FINDINGS: Several observational studies and systematic reviews have demonstrated the feasibility and safety of TEER in cardiogenic shock complicated by degenerative or functional mitral regurgitation. Surgical interventions for mitral regurgitation remain limited owing to the risk profile of patients in cardiogenic shock. TEER has been studied in both degenerative and functional mitral regurgitation and remains feasible in the critically ill population. Moreover, TEER is associated with reduction in mitral regurgitation and improvement in-hospital and long-term mortality. SUMMARY: TEER remains a promising therapeutic option in cardiogenic shock complicated by significant mitral regurgitation, but additional research is required to identify patient and procedural characteristics, hemodynamic parameters, and the optimal time for intervention. Moreover, future randomized controlled trials are in progress to evaluate the potential benefit of TEER against medical management in cardiogenic shock and mitral regurgitation.

Inotropes, vasopressors, and mechanical circulatory support for treatment of cardiogenic shock complicating myocardial infarction: a systematic review and network meta-analysis.

PURPOSE: To compare the relative efficacy of supportive therapies (inotropes, vasopressors, and mechanical circulatory support [MCS]) for adult patients with cardiogenic shock complicating acute myocardial infarction. SOURCE: We conducted a systematic review and network meta-analysis and searched six databases from inception to December 2021 for randomized clinical trials (RCTs). We evaluated inotropes, vasopressors, and MCS in separate networks. Two reviewers performed screening, full-text review, and extraction. We used the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) framework to rate the certainty in findings. The critical outcome of interest was 30-day all-cause mortality. PRINCIPAL FINDINGS: We included 17 RCTs. Among inotropes (seven RCTs, 1,145 patients), levosimendan probably reduces mortality compared with placebo (odds ratio [OR], 0.53; 95% confidence interval [CI], 0.33 to 0.87; moderate certainty), but primarily in lower severity shock. Milrinone (OR, 0.52; 95% CI, 0.19 to 1.39; low certainty) and dobutamine (OR, 0.67, 95% CI, 0.30 to 1.49; low certainty) may have no effect on mortality compared with placebo. With regard to MCS (eight RCTs, 856 patients), there may be no effect on mortality with an intra-aortic balloon pump (IABP) (OR, 0.94; 95% CI, 0.69 to 1.28; low certainty) or percutaneous MCS (pMCS) (OR, 0.96; 95% CI, 0.47 to 1.98; low certainty), compared with a strategy involving no MCS. Intra-aortic balloon pump use was associated with less major bleeding compared with pMCS. We found only two RCTs evaluating vasopressors, yielding insufficient data for meta-analysis. CONCLUSION: The results of this systematic review and network meta-analysis indicate that levosimendan reduces mortality compared with placebo among patients with low severity cardiogenic shock. Intra-aortic balloon pump and pMCS had no effect on mortality compared with a strategy of no MCS, but pMCS was associated with higher rates of major bleeding. STUDY REGISTRATION: Center for Open Science ( https://osf.io/ky2gr ); registered 10 November 2020.

RéSUMé: OBJECTIF: Comparer l'efficacité relative des thérapies de soutien (inotropes, vasopresseurs et assistance circulatoire mécanique [ACM]) chez les patients adultes atteints d'un choc cardiogénique compliquant un infarctus aigu du myocarde. SOURCES: Nous avons réalisé une revue systématique et une méta-analyse en réseau et effectué des recherches dans six bases de données depuis leur création jusqu'à décembre 2021 pour en tirer les études randomisées contrôlées (ERC). Nous avons évalué les inotropes, les vasopresseurs et les ACM dans des réseaux distincts. Deux réviseurs ont effectué la recherche, l'évaluation du texte intégral et l'extraction. Nous avons utilisé le système de notation GRADE (Grading of Recommendations Assessment, Development, and Evaluation) pour évaluer la certitude des résultats. Le critère d'évaluation d'intérêt était la mortalité toutes causes confondues à 30 jours. CONSTATATIONS PRINCIPALES: Nous avons inclus 17 ERC. Parmi les inotropes (sept ERC, 1145 patients), le lévosimendan a probablement réduit la mortalité par rapport au placebo (rapport de cotes [RC], 0,53; intervalle de confiance [IC] à 95 %, 0,33 à 0,87; certitude modérée), mais principalement en cas de choc de sévérité moindre. La milrinone (RC, 0,52; IC 95 %, 0,19 à 1,39; certitude faible) et la dobutamine (RC, 0,67, IC 95 %, 0,30 à 1,49; certitude faible) pourraient n'avoir aucun effet sur la mortalité par rapport au placebo. En ce qui concerne l'ACM (huit ERC, 856 patients), il pourrait n'y avoir aucun effet sur la mortalité avec un ballon intra-aortique (IABP) (RC, 0,94; IC 95 %, 0,69 à 1,28; certitude faible) ou un ACM percutané (ACMp) (RC, 0,96; IC 95 %, 0,47 à 1,98; certitude faible), par rapport à une stratégie sans ACM. L'utilisation d'un ballon intra-aortique était associée à moins de saignements majeurs par rapport à une ACMp. Nous n'avons trouvé que deux ERC évaluant les vasopresseurs, ce qui n'a pas fourni suffisamment de données pour la méta-analyse. CONCLUSION: Les résultats de cette revue systématique et de la méta-analyse en réseau indiquent que le lévosimendan réduit la mortalité par rapport au placebo chez les patients présentant un choc cardiogénique de faible gravité. Le ballon intra-aortique et l'ACMp n'ont eu aucun effet sur la mortalité par rapport à une stratégie sans ACM, mais l'ACMp était associée à des taux plus élevés de saignements majeurs. ENREGISTREMENT DE L'éTUDE: Center for Open Science ( https://osf.io/ky2gr ); enregistrée le 10 novembre 2020.

Revisiting the Evidence for Dipyridamole in Reducing Restenosis: A Systematic Review and Meta-analysis.

ABSTRACT: Atherosclerosis remains a leading cause of morbidity and mortality, with revascularization remaining a cornerstone of management. Conventional revascularization modalities remain challenged by target vessel reocclusion-an event driven by mechanical, thrombotic, and proliferative processes. Despite considerable advancements, restenosis remains the focus of ongoing research. Adjunctive agents, including dipyridamole, offer a multitude of effects that may improve vascular homeostasis. We sought to quantify the potential therapeutic impact of dipyridamole on vascular occlusion. We performed a literature search (EMBASE and MEDLINE) examining studies that encompassed 3 areas: (1) one of the designated medical therapies applied in (2) the setting of a vascular intervention with (3) an outcome including vascular occlusion rates and/or quantification of neointimal proliferation/restenosis. The primary outcome was vascular occlusion rates. The secondary outcome was the degree of restenosis by neointimal quantification. Both human and animal studies were included in this translational analysis. There were 6,839 articles screened, from which 73 studies were included, encompassing 16,146 vessels followed up for a mean of 327.3 days (range 7-3650 days). Preclinical studies demonstrate that dipyridamole results in reduced vascular occlusion rates {24.9% vs. 48.8%, risk ratio 0.53 [95% confidence interval (CI) 0.40-0.70], I2 = 39%, P < 0.00001}, owing to diminished neointimal proliferation [standardized mean differences -1.13 (95% CI -1.74 to -0.53), I2 = 91%, P = 0.0002]. Clinical studies similarly demonstrated reduced occlusion rates with dipyridamole therapy [23.5% vs. 31.0%, risk ratio 0.77 (95% CI 0.67-0.88), I2 = 84%, P < 0.0001]. Dipyridamole may improve post-intervention vascular patency and mitigate restenosis. Dedicated studies are warranted to delineate its role as an adjunctive agent after revascularization.

Impact of baseline beta-blocker use on inotrope response and clinical outcomes in cardiogenic shock: a subgroup analysis of the DOREMI trial.

BACKGROUND: Cardiogenic shock (CS) is associated with significant morbidity and mortality. The impact of beta-blocker (BB) use on patients who develop CS remains unknown. We sought to evaluate the clinical outcomes and hemodynamic response profiles in patients treated with BB in the 24 h prior to the development of CS. METHODS: Patients with CS enrolled in the DObutamine compaREd to MIlrinone trial were analyzed. The primary outcome was a composite of all-cause mortality, resuscitated cardiac arrest, need for cardiac transplant or mechanical circulatory support, non-fatal myocardial infarction, transient ischemic attack or stroke, or initiation of renal replacement therapy. Secondary outcomes included the individual components of the primary composite and hemodynamic response profiles derived from pulmonary artery catheters. RESULTS: Among 192 participants, 93 patients (48%) had received BB therapy. The primary outcome occurred in 47 patients (51%) in the BB group and in 52 (53%) in the no BB group (RR 0.96; 95% CI 0.73-1.27; P = 0.78) throughout the in-hospital period. There were fewer early deaths in the BB group (RR 0.41; 95% CI 0.18-0.95; P = 0.03). There were no differences in other individual components of the primary outcome or in hemodynamic response between the two groups throughout the remainder of the hospitalization. CONCLUSIONS: BB therapy in the 24 h preceding the development of CS did not negatively influence clinical outcomes or hemodynamic parameters. On the contrary, BB use was associated with fewer deaths in the early resuscitation period, suggesting a paradoxically protective effect in patients with CS. Trial registration ClinicalTrials.gov Identifier: NCT03207165.

Journal Initiatives to Enhance Preclinical Research: Analyses of Stroke, Nature Medicine, Science Translational Medicine.

Background and Purpose- Preclinical research using animals often informs clinical trials. However, its value is dependent on its scientific validity and reproducibility, which are, in turn, dependent on rigorous study design and reporting. In 2011, Stroke introduced a Basic Science Checklist to enhance the reporting and methodology of its preclinical studies. Except for Nature and Science journals, few others have implemented similar initiatives. We sought to estimate the impact of these journal interventions on the quality of their published reports. Methods- All articles published in Stroke, Nature Medicine, and Science Translational Medicine over 9 to 18 years and in 2 control journals without analogous interventions over a corresponding 11.5 years were reviewed to identify reports of experiments in nonhuman mammals with proposed clinical relevance. The effect of journal interventions on the reporting and use of key study design elements was estimated via interrupted time-series analyses. Results- Of 33 009 articles screened, 4162 studies met inclusion criteria. In the 3.5 to 12 years preceding each journal's intervention, the proportions of studies reporting and using key study design elements were stable except for blinding in Stroke and randomization in Science Translational Medicine, which were both increasing. Post-intervention, abrupt and often marked increases were seen in the reporting of randomization status (level change: +17% to +44%, P≤0.005), blinding (level change: +20% to +40%, P≤0.008), and sample size estimation (level change: 0% to +40%, P≤0.002 in 2 journals). Significant but more modest improvements in the use of these study design elements were also observed. These improvements were not seen in control journals. Conclusions- Journal interventions such as Stroke's author submission checklist can meaningfully improve the quality of published preclinical research and should be considered to enhance study transparency and design. However, such interventions are alone insufficient to fully address widespread shortcomings in preclinical research practices.

New-onset atrial fibrillation and associated outcomes and resource use among critically ill adults-a multicenter retrospective cohort study.

BACKGROUND: New-onset atrial fibrillation (NOAF) is commonly encountered in critically ill adults. Evidence evaluating the association between NOAF and patient-important outcomes in this population is conflicting. Furthermore, little is known regarding the association between NOAF and resource use or hospital costs. METHODS: Retrospective analysis (2011-2016) of a prospectively collected registry from two Canadian hospitals of consecutive ICU patients aged ≥ 18 years. We excluded patients with a known history of AF prior to hospital admission. Any occurrence of atrial fibrillation (AF) was prospectively recorded by bedside nurses. The primary outcome was hospital mortality, and we used multivariable logistic regression to adjust for confounders. We used a generalized linear model to evaluate contributors to total cost. RESULTS: We included 15,014 patients, and 1541 (10.3%) had NOAF during their ICU admission. While NOAF was not associated with increased odds of hospital death among the entire cohort (adjusted odds ratio [aOR] 1.02 [95% confidence interval [CI] 0.97-1.08]), an interaction was noted between NOAF and sepsis, and the presence of both was associated with higher odds of hospital mortality (aOR 1.28 [95% CI 1.09-1.36]) than either alone. Patients with NOAF had higher total costs (cost ratio [CR] 1.09 [95% CI 1.02-1.20]). Among patients with NOAF, treatment with a rhythm-control strategy was associated with higher costs (CR 1.24 [95% CI 1.07-1.40]). CONCLUSIONS: While NOAF was not associated with death or requiring discharge to long-term care among critically ill patients, it was associated with increased length of stay in ICU and increased total costs.

Evaluation of an in vitro coronary stent thrombosis model for preclinical assessment.

Stent thrombosis remains an infrequent but significant complication following percutaneous coronary intervention. Preclinical models to rapidly screen and validate therapeutic compounds for efficacy are lacking. Herein, we describe a reproducible, high throughput and cost-effective method to evaluate candidate therapeutics and devices for either treatment or propensity to develop stent thrombosis in an in vitro bench-top model. Increasing degree of stent malapposition (0.00 mm, 0.10 mm, 0.25 mm and 0.50 mm) was associated with increasing thrombosis and luminal area occlusion (4.1 ± 0.5%, 6.3 ± 0.5%, 19.7 ± 4.5%, and 92.6 ± 7.4%, p < 0.0001, respectively). Differences in stent design in the form of bare-metal, drug-eluting, and bioresorbable vascular scaffolds demonstrated differences in stent thrombus burden (14.7 ± 3.8% vs. 20.5 ± 3.1% vs. 86.8 ± 5.3%, p < 0.01, respectively). Finally, thrombus burden was significantly reduced when healthy blood samples were incubated with Heparin, ASA/Ticagrelor (DAPT), and Heparin+DAPT compared to control (DMSO) at 4.1 ± 0.6%, 6.9 ± 1.7%, 4.5 ± 1.2%, and 12.1 ± 1.8%, respectively (p < 0.01). The reported model produces high throughput reproducible thrombosis results across a spectrum of antithrombotic agents, stent design, and degrees of apposition. Importantly, performance recapitulates clinical observations of antiplatelet/antithrombotic regimens as well as device and deployment characteristics. Accordingly, this model may serve as a screening tool for candidate therapies in preclinical evaluation.

Impact of trainee involvement on patient radiation exposure and contrast volumes during invasive cardiac procedures.

PURPOSE: The impact of cardiology fellows (CFs) and interventional cardiology fellows (ICFs) on patient radiation and contrast exposure during diagnostic coronary angiography and percutaneous coronary intervention is unknown. METHODS: Between 2011 and 2014, 16,175 cases were retrospectively assessed involving 27 CFs, 22 ICFs and 24 staff as primary operators. RESULTS: During diagnostic coronary angiography, ICFs administered the lowest radiation dose (5,648±5,523 cGy*cm2; 1.30 ± 1.27 mSv)-achieving 22% less radiation than the staff (6,889±4,294 cGy*cm2; 1.58 ± 0.99 mSv) and 36% less than CFs (7,700±6,751 cGy*cm2; 1.77 ± 1.55 mSv) (p<0.01). When adjusted for access site, CFs administered more radiation than either the ICFs or staff. However, differences between ICFs and staff were exclusively observed during transradial procedures (p<0.01). With regards to contrast administration, ICFs administered less contrast (126.3 ± 57.6 mL) than either CFs (130±52.4 mL) or staff (132.7±47.6 mL) (p<0.01)-again, a finding isolated to the transradial cohort. Of the 6,751 percutaneous coronary intervention cases, no significant differences existed between the ICFs or staff cardiologists in patient radiation exposure-but a CF as the primary operator resulted in an 18% increase in radiation exposure. Notably, contrast use was not different amongst the types of operators (p<0.05). CONCLUSION: In conclusion, having a cardiology fellow as primary operator during invasive cardiac procedures increases patient radiation exposure and minimally increases contrast administration. Strategies to minimize patient radiation exposure while maintaining trainee involvement should be evaluated.

Long-term mortality and costs following use of Impella® for mechanical circulatory support: a population-based cohort study.

PURPOSE: The Impella® device is a form of mechanical circulatory support (MCS) used in critically ill adults with cardiogenic shock. We sought to evaluate short- and long-term outcomes following the use of Impella, including mortality, healthcare utilization, and costs. METHODS: Population-based, retrospective cohort study of adult patients (≥ 16 yr) receiving Impella in Ontario, Canada (1 April 2012-31March 2019). We captured outcomes through linkage to health administrative databases. The primary outcome was mortality during hospitalization. Secondary outcomes included mortality at 30 days, 90 days, and one year following Impella insertion. We analyzed health system costs in Canadian dollars in the year following the date of the index admission, including the costs of inpatient admission. RESULTS: We included 162 patients. Mean (standard deviation) age was 59.2 (14.5) yr, and 73.5% of patients were male. Median [interquartile range (IQR)] time to Impella insertion from date of hospital admission was 2 [1-9] days. In-hospital mortality was 56.8%, and a significant proportion of patients were bridged to a ventricular assist device (67.9%). Mortality at one year was 61.7%. Among hospital survivors, only 38.6% were discharged home independently. Median [IQR] total cost in the year following admission among all patients was $88,397 [32,718-225,628], of which $66,529 [22,789-183,165] was attributed to inpatient care. CONCLUSIONS: In-hospital mortality among patients with cardiogenic shock receiving Impella is high, but with minimal increase at one year. While Impella patients accrued substantial costs, these largely reflected inpatient costs, and not costs incurred following hospital discharge.

RéSUMé: OBJECTIF: Le dispositif Impella® est un système d'assistance circulatoire mécanique utilisé chez les adultes en état critique souffrant d'un choc cardiogénique. Nous avons souhaité évaluer les issues à court et à long terme liées à l'utilisation de l'Impella, notamment la mortalité, l'utilisation des soins de santé et les coûts. MéTHODE: Nous avons réalisé une étude de cohorte rétrospective basée sur une population de patients adultes (≥ 16 ans) recevant un Impella en Ontario, au Canada (1er avril 2012­31 mars 2019). Nous avons saisi les données pertinentes à nos critères d'évaluation en créant des liens avec les bases de données administratives de santé. Le critère d'évaluation principal était la mortalité pendant l'hospitalisation. Les critères d'évaluation secondaires comportaient la mortalité à 30 jours, 90 jours et un an après l'insertion de l'Impella. Nous avons analysé les coûts pour le système de santé en dollars canadiens au cours de l'année suivant la date d'admission initiale, notamment les coûts hospitaliers. RéSULTATS: Nous avons inclus 162 patients. L'âge moyen (écart type) était de 59,2 (14,5) ans, et 73,5 % des patients étaient des hommes. Le temps médian [écart interquartile (ÉIQ)] jusqu'à insertion de l'Impella depuis l'admission à l'hôpital était de 2 [1­9] jours. La mortalité hospitalière était de 56,8 %, et un dispositif d'assistance ventriculaire a été implanté chez une importante proportion de patients (67,9 %). La mortalité à un an était de 61,7 %. Parmi les survivants hospitaliers, seuls 38,6 % ont reçu leur congé pour un retour indépendant à la maison. Le coût total médian [ÉIQ] pour l'année suivant l'admission parmi tous les patients était de 88 397 $ [32 718 ­ 225 628 $], dont 66 259 $ [22 789 ­ 183 165 $] étaient attribuables aux soins hospitaliers. CONCLUSION: La mortalité hospitalière parmi les patients en choc cardiogénique chez lesquels un Impella est installé est élevée, mais on n'observe qu'une augmentation minimale à un an. Alors que les patients ayant reçu un Impella ont engendré des coûts importants, ces coûts reflètent principalement les coûts hospitaliers et non les coûts encourus après le congé de l'hôpital.

Comparative Accuracy of Focused Cardiac Ultrasonography and Clinical Examination for Left Ventricular Dysfunction and Valvular Heart Disease: A Systematic Review and Meta-analysis.

Background: Incorporating focused cardiac ultrasonography (FoCUS) into clinical examination could improve the diagnostic yield of bedside patient evaluation. Purpose: To compare the accuracy of FoCUS-assisted clinical assessment versus clinical assessment alone for diagnosing left ventricular dysfunction or valvular disease in adults having cardiovascular evaluation. Data Sources: English-language searches of MEDLINE, Embase, and Web of Science from 1 January 1990 to 23 May 2019 and review of reference citations. Study Selection: Eligible studies were done in patients having cardiovascular evaluation; compared FoCUS-assisted clinical assessment versus clinical assessment alone for the diagnosis of left ventricular systolic dysfunction, aortic or mitral valve disease, or pericardial effusion; and used transthoracic echocardiography as the reference standard. Data Extraction: Three study investigators independently abstracted data and assessed study quality. Data Synthesis: Nine studies were included in the meta-analysis. The sensitivity of clinical assessment for diagnosing left ventricular dysfunction (left ventricular ejection fraction <50%) was 43% (95% CI, 33% to 54%), whereas that of FoCUS-assisted examination was 84% (CI, 74% to 91%). The specificity of clinical assessment was 81% (CI, 65% to 90%), and that of FoCUS-assisted examination was 89% (CI, 85% to 91%). The sensitivities of clinical assessment and FoCUS-assisted examination for diagnosing aortic or mitral valve disease (of at least moderate severity) were 46% (CI, 35% to 58%) and 71% (CI, 63% to 79%), respectively. Both the clinical assessment and the FoCUS-assisted examination had a specificity of 94% (CI, 91% to 96%). Limitation: Evidence was scant, persons doing ultrasonography had variable skill levels, and most studies had unclear or high risk of bias. Conclusion: Clinical examination assisted by FoCUS has greater sensitivity, but not greater specificity, than clinical assessment alone for identifying left ventricular dysfunction and aortic or mitral valve disease; FoCUS-assisted examination may help rule out cardiovascular pathology in some patients, but it may not be sufficient for definitive confirmation of cardiovascular disease suspected on physical examination. Primary Funding Source: None. (PROSPERO: CRD42019124318).

Methodological Rigor in Preclinical Cardiovascular Studies: Targets to Enhance Reproducibility and Promote Research Translation.

RATIONALE: Methodological sources of bias and suboptimal reporting contribute to irreproducibility in preclinical science and may negatively affect research translation. Randomization, blinding, sample size estimation, and considering sex as a biological variable are deemed crucial study design elements to maximize the quality and predictive value of preclinical experiments. OBJECTIVE: To examine the prevalence and temporal patterns of recommended study design element implementation in preclinical cardiovascular research. METHODS AND RESULTS: All articles published over a 10-year period in 5 leading cardiovascular journals were reviewed. Reports of in vivo experiments in nonhuman mammals describing pathophysiology, genetics, or therapeutic interventions relevant to specific cardiovascular disorders were identified. Data on study design and animal model use were collected. Citations at 60 months were additionally examined as a surrogate measure of research impact in a prespecified subset of studies, stratified by individual and cumulative study design elements. Of 28 636 articles screened, 3396 met inclusion criteria. Randomization was reported in 21.8%, blinding in 32.7%, and sample size estimation in 2.3%. Temporal and disease-specific analyses show that the implementation of these study design elements has overall not appreciably increased over the past decade, except in preclinical stroke research, which has uniquely demonstrated significant improvements in methodological rigor. In a subset of 1681 preclinical studies, randomization, blinding, sample size estimation, and inclusion of both sexes were not associated with increased citations at 60 months. CONCLUSIONS: Methodological shortcomings are prevalent in preclinical cardiovascular research, have not substantially improved over the past 10 years, and may be overlooked when basing subsequent studies. Resultant risks of bias and threats to study validity have the potential to hinder progress in cardiovascular medicine as preclinical research often precedes and informs clinical trials. Stroke research quality has uniquely improved in recent years, warranting a closer examination for interventions to model in other cardiovascular fields.

Photoplethysmography using a smartphone application for assessment of ulnar artery patency: a randomized clinical trial.

BACKGROUND: Radial artery access is commonly performed for coronary angiography and invasive hemodynamic monitoring. Despite limitations in diagnostic accuracy, the modified Allen test (manual occlusion of radial and ulnar arteries followed by release of the latter and assessment of palmar blush) is used routinely to evaluate the collateral circulation to the hand and, therefore, to determine patient eligibility for radial artery access. We sought to evaluate whether a smartphone application may provide a superior alternative to the modified Allen test. METHODS: We compared the modified Allen test with a smartphone heart rate-monitoring application (photoplethysmography readings detected using a smartphone camera lens placed on the patient's index finger) in patients undergoing a planned cardiac catheterization. Test order was randomly assigned in a 1:1 fashion. All patients then underwent conventional plethysmography of the index finger, followed by Doppler ultrasonography of the radial and ulnar arteries (the diagnostic standard). The primary outcome was diagnostic accuracy of the heart rate-monitoring application. RESULTS: Among 438 patients who were included in the study, we found that the heart rate-monitoring application had a superior diagnostic accuracy compared with the modified Allen test (91.8% v. 81.7%, p = 0.002), attributable to its greater specificity (93.0% v. 82.8%, p = 0.001). We also found that this application had greater diagnostic accuracy for assessment of radial or ulnar artery patency in the ipsilateral and contralateral wrist (94.0% v. 84.0%, p < 0.001). INTERPRETATION: A smartphone application used at the bedside was diagnostically superior to traditional physical examination for confirming ulnar patency before radial artery access. This study highlights the potential for smartphone-based diagnostics to aid in clinical decision-making at the patient's bedside. Trial registration: Clinicaltrials.gov, no. NCT02519491.

Association between plasminogen activator inhibitor-1 and cardiovascular events: a systematic review and meta-analysis.

BACKGROUND: Small studies have implicated plasminogen activator inhibitor-1 (PAI-1) as a predictor of cardiovascular events; however, these findings have been inconsistent.We sought out to examine the potential role of PAI-1 as a marker for major adverse cardiovascular events (MACE). METHODS: We systematically reviewed all indexed studies examining the association between PAI-1 and MACE (defined as death, myocardial infarction, or cerebrovascular accident) or restenosis. EMBASE, Web of Science, Medline, and the Cochrane Library were searched through October 2016 to identify relevant studies, supplemented by letters to authors and review of citations. Studies reporting the results of PAI-1 antigen and/or activity levels in association with MACE in human subjects were included. RESULTS: Of 5961 articles screened, we identified 38 articles published between 1991 to 2016 that reported PAI-1 levels in 11,557 patients. In studies that examined PAI-1 antigen and activity levels, 15.1% and 29.6% of patients experienced MACE, respectively. Patients with MACE had higher PAI-1 antigen levels with a mean difference of 6.11 ng/mL (95% CI, 3.27-8.96). This finding was similar among patients with and without known coronary artery disease. Comparatively, studies that stratified by PAI-1 activity levels were not associated with MACE. In contrast, studies of coronary restenosis suggest PAI-1 antigen and activity levels are negatively associated with MACE. CONCLUSIONS: Elevated plasma PAI-1 antigen levels are associated with MACE. Definitive studies are needed to ascertain if PAI-1 acts simply as a marker of risk or if it is indeed a bona fide therapeutic target.

Evaluation of Cobalt and Chromium Levels Following Implantation of Cobalt Chromium Coronary Stents: A Pilot Study.

BACKGROUND: Large increases in myocardial trace elements may adversely affect metabolism and become detrimental to cardiac function. Percutaneous coronary intervention (PCI) allows for the revascularisation of obstructive coronary artery disease using drug-eluting stents. These stents are comprised of a metallic stent backbone covered in an engineered polymer which delivers a drug over a prescribed period to the vessel wall. Given the potential implications of trace metal accumulation within the myocardium, our goal is to determine if metallic coronary stents are able to cause detectable elevations in serum cobalt and/or chromium levels. METHODS: This study was a single centre, observational, pilot study with 20 patients who underwent planned PCI with implantation of a cobalt chromium drug eluting stent. Serum blood samples were drawn at baseline prior to PCI, 4hours post-stent deployment and at the time of routine follow-up after PCI. All blood samples were analysed for cobalt and chromium concentrations. The primary outcome of this study was the difference in serum cobalt and chromium levels at routine clinical follow-up. RESULTS: The mean follow up was 64.1±17.3 days. There was no difference in serum cobalt levels when comparing baseline and routine clinical follow up (3.32±2.14nmol/L vs. 3.14±1.00nmol/L, p=0.99) nor in chromium levels (4.24±2.31nmol/L vs. 2.82±1.22 nmol/L, p=0.11). There was also no difference between baseline and 4hours post-PCI serum concentrations. CONCLUSIONS: Percutaneous coronary intervention with cobalt chromium coronary stents does not appear to cause an elevation in these trace element serum concentrations.