Remote management in patients with heart failure (from new onset to advanced): A practical guide.

Heart failure is a chronic condition that affects millions of people worldwide and is associated with high morbidity and mortality. Remote monitoring, which includes the use of non-invasive connected devices, cardiac implantable electronic devices and haemodynamic monitoring systems, has the potential to improve outcomes for patients with heart failure. Despite the conceptual and clinical advantages, there are still limitations in the widespread use of these technologies. Moreover, a significant proportion of studies evaluating the benefit of remote monitoring in heart failure have focused on the limited area of prevention of rehospitalization after an episode of acute heart failure. A group of experts in the fields of heart failure and digital health worked on this topic in order to provide a practical paper for the use of remote monitoring in clinical practice at the different stages of the heart failure syndrome: (1) discovery of heart failure; (2) acute decompensation of chronic heart failure; (3) heart failure in stable period; and (4) advanced heart failure. A careful and critical analysis of the available literature was performed with the aim of providing caregivers with some recommendations on when and how to use remote monitoring in these different situations, specifying which variables are essential, optional or useless.

Evaluation of the R-One robotic system for percutaneous coronary intervention: the R-EVOLUTION study.

BACKGROUND: R-One is a robotic percutaneous coronary intervention (PCI) system (CE mark 2019) designed to reduce operator radiation exposure, improve ergonomics, and accurately navigate, position, and deliver guidewires/devices during PCI. AIMS: We aimed to evaluate the safety and efficacy of the R-One system for PCI. METHODS: The European multicentre prospective R-EVOLUTION study included patients with a de novo coronary artery stenosis (length <38 mm, reference diameter 2.5-4.0 mm) undergoing stent implantation. Patients with recent ST-segment elevation myocardial infarction, ostial or left main lesion, bifurcation, severe tortuosity, or calcification were excluded. Clinical success was defined as the absence of major intraprocedural complications. Technical success was defined as the successful advancement and retraction of all PCI devices (guidewires/balloon/stents) without total manual conversion. Radiation exposure to patients, to a simulated manual operator, and to robotic PCI operators was measured. RESULTS: Sixty-two consecutive patients (B2/C lesions: 25.0% [16/64]) underwent robotic PCI. Radial access was used in 96.8% (60/62) of procedures. The mean robotic procedure duration was 19.9±9.6 min and the mean fluoroscopy time was 10.3±5.4 min. Clinical success was 100% with no complications at 30 days. Technical success was 95.2% (59/62). Total manual conversion was required in 4.8% (3/62) cases, with 1 case directly related to the robotic system. Operator radiation exposure was reduced by 84.5% under and 77.1% on top of the lead apron, compared to doses received on the patient table. CONCLUSIONS: This study suggests that robotic PCI using R-One is safe and effective with markedly lower radiation exposure to the operator. Further studies are needed to evaluate R-One in larger patient populations with more complex lesions. (ClinicalTrials.gov: NCT04163393).

A telemonitoring programme in patients with heart failure in France: a cost-utility analysis.

BACKGROUND: Certain telemedicine programmes for heart failure (HF) have been shown to reduce all-cause mortality and heart failure-related hospitalisations, but their cost-effectiveness remains controversial. The SCAD programme is a home-based interactive telemonitoring service for HF, which is one of the largest and longest-running telemonitoring programmes for HF in France. The objective of this cost-utility analysis was to evaluate the cost-effectiveness of the SCAD programme with respect to standard hospital-based care in patients with HF. METHODS: A Markov model simulating hospitalisations and mortality in patients with HF was constructed to estimate outcomes and costs. The model included six distinct health states (three 'not hospitalised' states, two 'hospitalisation for heart failure' states, both depending on the number of previous hospitalisations, and one death state). The model lifetime in the base case was 10 years. Model inputs were based on published literature. Outputs (costs and QALYs) were compared between SCAD participants and standard care. Deterministic and probabilistic sensitivity analyses were performed to assess uncertainty in the input parameters of the model. RESULTS: The number of quality-adjusted life years (QALYs) was 3.75 in the standard care setting and 4.41 in the SCAD setting. This corresponds to a gain in QALYs provided by the SCAD programme of 0.65 over the 10 years lifetime of the model. The estimated total cost was €30,932 in the standard care setting and €35,177 in the SCAD setting, with an incremental cost of €4245. The incremental cost-effectiveness ratio (ICER) for the SCAD programme over standard care was estimated at €4579/QALY. In the deterministic sensitivity analysis, the variables that had the most impact on the ICER were HF management costs. The likelihood of the SCAD programme being considered cost-effective was 90% at a willingness-to-pay threshold of €11,800. CONCLUSIONS: Enrolment of patients into the SCAD programme is highly cost-effective. Extension of the programme to other hospitals and more patients would have a limited budget impact but provide important clinical benefits. This finding should also be taken into account in new public health policies aimed at encouraging a shift from inpatient to ambulatory care.

Assessing a New Prescreening Score for the Simplified Evaluation of the Clinical Quality and Relevance of eHealth Apps: Instrument Validation Study.

BACKGROUND: In 2020, more than 250 eHealth solutions were added to app stores each day, or 90,000 in the year; however, the vast majority of these solutions have not undergone clinical validation, their quality is unknown, and the user does not know if they are effective and safe. We sought to develop a simple prescreening scoring method that would assess the quality and clinical relevance of each app. We designed this tool with 3 health care stakeholder groups in mind: eHealth solution designers seeking to evaluate a potential competitor or their own tool, investors considering a fundraising candidate, and a hospital clinician or IT department wishing to evaluate a current or potential eHealth solution. OBJECTIVE: We built and tested a novel prescreening scoring tool (the Medical Digital Solution scoring tool). The tool, which consists of 26 questions that enable the quick assessment and comparison of the clinical relevance and quality of eHealth apps, was tested on 68 eHealth solutions. METHODS: The Medical Digital Solution scoring tool is based on the 2021 evaluation criteria of the French National Health Authority, the 2022 European Society of Medical Oncology recommendations, and other provided scores. We built the scoring tool with patient association and eHealth experts and submitted it to eHealth app creators, who evaluated their apps via the web-based form in January 2022. After completing the evaluation criteria, their apps obtained an overall score and 4 categories of subscores. These criteria evaluated the type of solution and domain, the solution's targeted population size, the level of clinical assessment, and information about the provider. RESULTS: In total, 68 eHealth solutions were evaluated with the scoring tool. Oncology apps (22%, 20/90) and general health solutions (23%, 21/90) were the most represented. Of the 68 apps, 32 (47%) were involved in remote monitoring by health professionals. Regarding clinical outcomes, 5% (9/169) of the apps assessed overall survival. Randomized studies had been conducted for 21% (23/110) of the apps to assess their benefit. Of the 68 providers, 38 (56%) declared the objective of obtaining reimbursement, and 7 (18%) out of the 38 solutions seeking reimbursement were assessed as having a high probability of reimbursement. The median global score was 11.2 (range 4.7-17.4) out of 20 and the distribution of the scores followed a normal distribution pattern (Shapiro-Wilk test: P=.33). CONCLUSIONS: This multidomain prescreening scoring tool is simple, fast, and can be deployed on a large scale to initiate an assessment of the clinical relevance and quality of a clinical eHealth app. This simple tool can help a decision-maker determine which aspects of the app require further analysis and improvement.

Impact of patient engagement in a French telemonitoring programme for heart failure on hospitalization and mortality.

AIMS: Management of patients with recently decompensated heart failure by hospital services is expensive, complicated to plan, and not always effective. Telemedicine programmes in heart failure may improve the quality of care, but their effectiveness is poorly documented in real-world settings. The study aims to evaluate the impact of patient engagement in home-based telemonitoring for heart failure (SCAD programme) on rehospitalization and mortality rates. METHODS AND RESULTS: A retrospective observational study was performed in 659 SCAD participants. SCAD is a patient-oriented service of home-based interactive telemonitoring offered to heart failure patients during hospitalization who agree to participate in a therapeutic education programme. Patients were telemonitored for at least 3 months, and rehospitalization and mortality were documented at 12 months and 5 years. During the telemonitoring period, patients provided daily information on health and lifestyle through an internet-based interface. Data were linked on a patient-by-patient basis between the SCAD database and the French national health insurance database (Système National des Données de Santé). Outcomes were compared as a function of use of the programme. Low, intermediate, and high users were classified by tercile of data return during telemonitoring. Patients were followed for a median of 32.9 months. Rehospitalization rates for cardiovascular disease decreased from 79.4% in the year preceding enrolment to 41.1% in the following year and from 52.8% to 18.8% for hospitalizations for heart failure. The 12 month mortality rate was 11.2%. Significant associations were observed between level of use of the SCAD programme and all-cause rehospitalization (P = 0.0085), rehospitalization for cardiovascular disease (P = 0.0010), rehospitalization for heart failure (27.8% in low users, 12.9% in intermediate users, and 13.5% in high users; P < 0.0001), and mortality (26.8%, 15.2%, and 15.9% respectively; P = 0.0157) in the 12 months following enrolment. The mean number of days alive outside hospital were 279 ± 111 in low users, 312 ± 90 in intermediate users, and 304 ± 100 in high users (P = 0.0022). CONCLUSIONS: Educational home telemonitoring of patients with heart failure following hospitalization provides long-term clinical benefits in terms of rehospitalization and death in real-world settings, according to the level of use of the programme by the patient. These benefits would be expected to have a major impact on the burden of this disease. Low engagement in telemonitoring could be used as a signal of poor prognosis and taken into account in the management strategy.

Impact of wait times on late postprocedural mortality after successful transcatheter aortic valve replacement.

Wait times are associated with mortality on waiting list for transcatheter aortic valve replacement (TAVR). Whether longer wait times are associated with long term mortality after successful TAVR remains unassessed. Consecutive patients successfully treated with elective TAVR in our center between January 2013 and August 2019 were included. The primary end point was one-year all-cause mortality. TAVR wait times were defined as the interval from referral date for valve replacement to the date of TAVR procedure. A total of 383 patients were included with a mean wait time of 144.2 ± 83.87 days. Death occurred in 55 patients (14.4%) at one year. Increased wait times were independently associated with a relative increase of 1-year mortality by 2% per week after referral (Adjusted Hazard Ratio 1.02 [1.002-1.04]; p = 0.02) for TAVR. Chronic kidney disease, left ventricular ejection fraction ≤ 30%, access site and STS score were other independent correlates of 1-year mortality. Our study shows that wait times are relatively long in routine practice and associated with increased 1-year mortality after successful TAVR. Such findings underscore the need of strategies to minimize delays in access to TAVR.

Extracorporeal Cardiopulmonary Resuscitation and Survival After Refractory Cardiac Arrest: Is ECPR Beneficial?

The level of evidence of expert recommendations for starting extracorporeal cardiopulmonary resuscitation (ECPR) in refractory out-of-hospital cardiac arrest (OHCA) and in-hospital cardiac arrest (IHCA) is low. Therefore, we reported our experience in the field to identify factors associated with hospital mortality. We conducted a retrospective cohort study of all consecutive patients treated with ECPR for refractory cardiac arrest without return to spontaneous circulation, regardless of cause, at the Caen University Hospital. Factors associated with hospital mortality were analyzed. Eighty-six patients (i.e., 35 OHCA and 51 IHCA) were included. The overall hospital mortality rate was 81% (i.e., 91% and 75% in the OHCA and IHCA groups, respectively). Factors independently associated with mortality were: sex, age > 44 years, and time from collapse until extracorporeal life support (ECLS) initiation. Interestingly, no-shockable rhythm was not associated with mortality. The receiver operating characteristic-area under the curve values of pH value (0.75 [0.60-0.90]) and time from collapse until ECLS initiation over 61 minutes (0.87 [0.76-0.98]) or 74 minutes (0.90 [0.80-1.00]) for predicting hospital mortality showed good discrimination performance. No-shockable rhythm should not be considered a formal exclusion criterion for ECPR. Time from collapse until ECPR initiation is the cornerstone of success of an ECPR strategy in refractory cardiac arrest.

Glycoprotein IIb/IIIa inhibitors use in the setting of primary percutaneous coronary intervention for ST elevation myocardial infarction in patients pre-treated with newer P2Y12 inhibitors.

OBJECTIVES: We sought to investigate the safety and potential benefit of administrating glycoprotein IIb-IIIa inhibitors (GPIs) on top of more potent P2Y12 inhibitors. BACKGROUND: A number of clinical trials, performed at a time when pretreatment and potent platelet inhibition was not part of routine clinical practice, have documented clinical benefits of GPI in ST-segment elevation myocardial infarction (STEMI) patients at the cost of a higher risk of bleeding. METHODS: We used the data of a prospective, ongoing registry of patients admitted for STEMI in our center. For the purpose of this study only patients presenting for primary percutaneous coronary intervention and pretreated with new P2Y12 inhibitors (prasugrel or ticagrelor) were included. We compared patients who received GPI with those who did not. RESULTS: Eight hundred twenty-four STEMI patients were included in our registry; GPIs were used in 338 patients (41%). GPI patients presented more often with cardiogenic shock and Thrombolysis in myocardial infarction (TIMI) flow grade <3. GPI use was not associated with an increase in in-hospital or 3-month mortality. Bleeding endpoints were similar in both groups. CONCLUSIONS: Our study suggests that GPI may be used safely in combination with recent P2Y12 inhibitors in STEMI patients in association with modern primary percutaneous coronary intervention strategies (radial access and anticoagulation with enoxaparin) with similar bleeding and mortality rates at hospital discharge and 3-month follow-up.

Safety and efficacy of very short dual antiplatelet therapy followed by P2Y12 inhibitor monotherapy in older patients undergoing percutaneous coronary intervention: meta-analysis of randomised controlled trials.

BACKGROUND: older patients undergoing percutaneous coronary intervention (PCI) represent a growing population sharing both a high ischemic and bleeding risk. Dual antiplatelet therapy (DAPT) reduces the incidence of thrombotic events but exposes patients to an increased risk of bleeding and subsequent mortality. Its optimal duration after PCI remains unclear. OBJECTIVE: to assess the impact of short-duration DAPT on both bleeding and ischemic events in the specific population of older patients undergoing PCI. METHODS: we performed a meta-analysis of randomised controlled trials comparing the safety and efficacy of standard versus very short duration (≤ 3 months, followed by P2Y12 inhibitor monotherapy) DAPT after PCI with a drug-eluting stent in older patients. RESULTS: four studies, representing 8,961 older patients, were finally included. Compared with standard duration, short-duration DAPT was associated with similar rates of major bleeding (relative risks, RR 0.70 [0.47; 1.05]) and the composite efficacy endpoint (RR 0.85 [0.63; 1.14]). There was a high level of heterogeneity between the studies (I2 = 68%) regarding major bleeding. CONCLUSION: our meta-analysis suggests that short DAPT may be a valid option in older patients after PCI but it also highlights the need for specific studies in such patients on optimal duration of antiplatelet therapy.

Evaluation of Left Main Coronary Artery Using Optical Frequency Domain Imaging and Its Pitfalls.

OBJECTIVES: We aimed to assess the quality of optical frequency domain imaging (OFDI) of the left main (LM) arterial wall and describe and analyse potential artefacts in this setting. BACKGROUND: OFDI is increasingly used to assess ambiguous lesions and optimize LM percutaneous coronary intervention. However, its ability to provide artefact-free high-quality images of coronary ostia and large segments such as the LM remains uncertain. METHODS: We included 42 consecutive patients who underwent OFDI, including LM imaging. Each OFDI frame was subdivided into four quadrants and analysed. The number of quadrants with artifacts was calculated within the proximal, mid, and distal LM and the first 5 mm of the left anterior descending artery (LAD) and/or left circumflex artery (LCX). RESULTS: The quadrants analysis showed an overall artifact rate of 8.9%, mostly out-of-field (45.1%) or residual blood (44.7%) artefacts. Most artifacts were located in the proximal LM (18.6%) with a stepwise reduction of artifact rates towards distal segments (mid LM 5.8%; distal LM 3.6%, ostial LAD 2.6%, and ostial LCX 0%; p < 0.001). While 20 (48.8%) patients had angiographically visible plaques, OFDI showed plaques in 32 patients (76.2%; p=0.007). CONCLUSION: OFDI can accurately evaluate the LM and detect and assess angiographically unvisualized atherosclerotic plaques providing accurate assessment of >90% of the quadrants of the LM and the ostia of its bifurcation branches. However, artifacts mainly located in the proximal LM and decreasing distally in a stepwise fashion should be considered in the interpretation of OFDI in this setting.

Usefulness of a personalized algorithm-based discharge checklist in patients hospitalized for acute heart failure.

AIMS: The aim of this study is to evaluate the usefulness of a personalized discharge checklist (PCL) based on simple baseline characteristics on mortality, readmission for heart failure (HF), and quality of care in patients hospitalized for acute HF. METHODS AND RESULTS: We designed an algorithm to generate PCL, based on 2016 HF European Society of Cardiology Guidelines and the screening of common comorbidities in elderly HF patients. We prospectively included 139 patients hospitalized for HF from May 2018 to October 2018. A PCL was fulfilled for each patient at admission and 24 to 48 hours before the planned discharge. A control cohort of 182 consecutive patients was retrospectively included from May 2017 to October 2017. The primary composite endpoint was mortality or readmission for HF at 6 months. The secondary endpoints were mortality, readmission for HF, and quality of care (evidence-based medications, management of HF comorbidities, and planned care plan). There was no difference among baseline characteristics between PCL and control cohorts; mean age was 78.1 ± 12.2 vs. 79.0 ± 12.5 years old (P = 0.46) and 61 patients (43.9%) vs. 63 (34.6%) had HF with left ventricular ejection fraction (LVEF) <40% (P = 0.24). During the 6 month follow-up period, 59 patients (42.4%) reached the primary endpoint in the PCL cohort vs. 92 patients (50.5%) in the control cohort [hazard ratio (HR): 0.79, 95% confidence interval (CI) (0.57-1.09), P = 0.15]. Subgroup analysis including only patients with either altered (<40%) or mid-range or preserved (≥40%) LVEF showed no significant difference among groups. There was a non-significant trend toward a reduction in HF readmission rate in the PCL group [38 patients (27.3%) vs. 64 patients (35.2%), HR: 0.73, 95%CI (0.49-1.09), P = 0.13]. There was no difference regarding survival or the use of evidence-based medications. A higher proportion of patients were screened and treated for iron and vitamin D deficiencies (53.2% vs. 35.7%, P < 0.01 and 73.4% vs. 29.7%, P < 0.01, respectively), as well as malnutrition supplemented in the PCL group. There was a higher referral to HF follow-up programme in the PCL group but not to telemedicine or cardiac rehabilitation programs. CONCLUSIONS: In this preliminary study, the use of a PCL did not improve outcomes at 6 months in patients hospitalized for acute HF. There was a non-significant trend towards a reduction in HF readmission rate in the PCL group. In addition, the management of HF comorbidities was significantly improved by PCL with a better referral to follow-up programme. A multicentre study is warranted to assess the usefulness of a simple costless personalized checklist in a large HF patients' population.

Residual platelet reactivity, thrombus burden and myocardial reperfusion in patients treated by PCI after successful pre-hospital fibrinolysis compared to primary PCI.

We compared residual platelet reactivity and post PCI atherothrombotic burden using OFDI in patients successfully treated by primary PCI versus pharmacoinvasive approach (PI) defined as PCI after successful pre-hospital fibrinolysis. Despite pre-hospital P2Y12-inhibitor loading dose, high rates of high on-treatment platelet reactivity were found at the time of PCI in both groups. Primary PCI patients had higher post stenting thrombus burden and lower rates of final normal myocardial blush grade compared to PI. These findings support the use of a pharmacoinvasive reperfusion strategy especially when primary PCI cannot be timely performed.

Factors Associated With the Choice of Oral Anticoagulant Class in the Older Patients: An Observational Study.

AIM: Oral anticoagulants are the first-line drugs for treating thrombotic disorders related to nonvalvular atrial fibrillation and for treating deep vein thrombosis, diseases that increase in prevalence with age. Older patients have a greater risk of thrombotic and hemorrhagic events and are more prone to drug interactions. Given this backdrop, we wanted to determine the factors associated with the prescription of direct oral anticoagulants and vitamin K antagonists in older patients. METHODS: We performed a cross-sectional observational study using a hospital prescription database. The study population consists of 405 older patients who were given oral anticoagulants. The 2 variables of interest were the prescription of 1 of the 2 classes of oral anticoagulants (direct oral anticoagulants vs vitamin K antagonists) and appropriateness of oral anticoagulant prescribing according to Summary of Product Characteristics (potentially inappropriate vs appropriate). RESULTS: The factors associated with direct oral anticoagulant prescribing were the female gender (odds ratio [OR]: 1.87, 95% confidence interval [CI]: 1.22-2.88) and initiation during hospital stay (OR: 2.56, 95% CI: [1.52-4.32]). Stage 4 and 5 chronic kidney diseases (OR: 0.39, 95% CI: [0.19-0.79] and OR: 0.07, 95% CI: [0.01-0.53]) were factors favoring vitamin K antagonist prescription. Being 90 years of age or more (OR: 2.05, 95% CI: [1.06-3.98]) was a factor for potentially inappropriate anticoagulant prescribing. The gastroenterology department (OR: 2.91, 95% CI: [1.05-8.11]) was associated with potentially inappropriate anticoagulant prescribing. CONCLUSIONS: Direct oral anticoagulants are the drugs of choice for anticoagulant treatment, including in older adults. The female gender and the initiation during hospital stay increased the chances of being prescribed a direct oral anticoagulant in older adults. Stage 4 and 5 chronic kidney disease increased the likelihood of having a vitamin K antagonist prescribed. Our study also revealed a persistence of potentially inappropriate oral anticoagulant prescriptions in older patients.

Systematic review and meta-analysis of the prognostic impact of cancer among patients with acute coronary syndrome and/or percutaneous coronary intervention.

BACKGROUND: Patients with cancer admitted for an acute coronary syndrome (ACS) and/or percutaneous coronary intervention (PCI) represent a growing and high-risk population. The influence of co-existing cancer on mortality remains unclear in such patients. We aimed to assess the impact of cancer on early and late, all-cause and cardiac mortality in the setting of ACS and/or PCI. METHODS: We performed a systematic review and meta-analysis of studies comparing outcomes of patients with and without a history of cancer admitted for ACS and/or PCI. RESULTS: Six studies including 294,528 ACS patients and three studies including 39,973 PCI patients were selected for our meta-analysis. Patients with cancer had increased rates of in-hospital all-cause death (RR 1.74 [1.22; 2.47]), cardiac death (RR 2.44 [1.73; 3.44]) and bleeding (RR 1.64 [1.35; 1.98]) as well as one-year all-cause death (RR 2.62 [1.2; 5.73]) and cardiac death (RR 1.89 [1.25; 2.86]) in ACS studies. Rates of long term all-cause (RR 1.96 [1.52; 2.53]) but not cardiac death were higher in cancer patients admitted for PCI. CONCLUSION: Cancer patients represent a high-risk population both in the acute phase and at long-term after an ACS or PCI. The magnitude of the risk of mortality should however be tempered by the heterogeneity among studies. Early and long term optimal management of such patients should be promoted in clinical practice.

Residual atherothrombotic burden after primary percutaneous coronary intervention and myocardial reperfusion-An optical frequency domain imaging study.

OBJECTIVES: We aimed to assess the relationship between residual in-stent atherothrombotic burden (ATB) after primary percutaneous coronary intervention (PCI) measured by optical frequency domain imaging (OFDI) using different measurement methods and myocardial blush grade (MBG). BACKGROUND: The impact of residual ATB after primary PCI on myocardial reperfusion remains unclear. METHODS: We prospectively included 60 ST-elevation myocardial infarction patients pretreated with aspirin and ticagrelor. OFDI volumetric quantification using planimetry (with intervals every frame or every millimeter) and semiquantitative score were used to determine ATB. Patients were divided into two groups according to final MBG 3 or <3. RESULTS: The mean ATB was 10.08 ± 5.21%. ATB was lower in patients with final MBG 3 compared to those with impaired MBG, regardless of the measurement method (8.15 ± 5.58 vs. 11.77 ± 4.28%; p = .007 for quantification per frame; 7.8 ± 5.19 vs. 11.07 ± 4.07%; p = .009 for quantification per mm and 11.21 ± 11.75 vs. 22.91 ± 17.35; p = .003 for the semiquantitative thrombus score, respectively). CONCLUSION: Residual post-stenting ATB remains substantial after primary PCI in STEMI patients, even when pretreated with ticagrelor and aspirin. ATB appears as a significant correlate of suboptimal myocardial reperfusion, a known surrogate of clinical outcome.

A head-to-head comparison of three coronary fractional flow reserve measurement technologies: The fractional flow reserve-device study.

OBJECTIVES: To compare three FFR technologies: the electric-sensor Pressurewire® (P), the optic-sensor Comet® (C) guidewire, and the optic-sensor Navvus® (N) microcatheter. BACKGROUND: Different technologies are used to measure fractional flow reserve (FFR) for the functional assessment of coronary lesions with potential discrepancies. METHODS: Sixty-six FFR measurements performed on 32 lesions using each technology were used for a paired comparison of FFR on simultaneous measurements and in clinically relevant conditions (guidewires alone, N on a guidewire). RESULTS: Simultaneous measurements of FFR were significantly (p < .0001) correlated between systems (ρ = 0.88, 0.81 and 0.86 for P and N, P and C and, C and N, respectively). The presence of the N microcatheter, led to reduced values of FFR measured by P or C guidewires (p < .0001). The concomitant presence of P and C guidewires led to significantly lower FFR values (p < .0001) measured by P but not by C. In clinically relevant conditions, values of FFR measured by the optic-sensor C guidewire and N catheter were similar and lower than those measured by the P guidewire (p < .0001). The agreement between the three technologies (FFR ≤ 0.80) was 94%. CONCLUSIONS: FFR values simultaneously measured by three different technologies, are strongly correlated, and provide strongly concordant results. However, significant differences are found between values of FFR. The presence of N, but also C lead to a decrease of FFR measured by P. In clinically relevant conditions, the two optic-sensor technologies provide similar FFR measurements, lower than those measured by the piezo-electric technology suggesting a sensor-technology-related measurement variability. CLINICAL TRIAL REGISTRATION: NCT#03052803.

Residual platelet reactivity after pre-treatment with ticagrelor prior to primary percutaneous coronary intervention is associated with suboptimal myocardial reperfusion.

BACKGROUND: The evidence of a clinical benefit of P2Y12 inhibitor pre-treatment in primary percutaneous coronary intervention (PCI) and the relation between the level of platelet inhibition and myocardial reperfusion with newer potent P2Y12 inhibitors remain unclear. We aimed to assess the relationship between platelet reactivity at the time of primary PCI after pre-treatment with aspirin and ticagrelor and the post-PCI myocardial blush grade (MBG). METHODS: We prospectively included 61 patients. Platelet reaction units for ticagrelor (PRU) and aspirin reaction units (ARU) were measured using the point-of-care test VerifyNow before PCI. The high on-ticagrelor (PRU >208) and on-aspirin (ARU ⩾ 550) platelet reactivity (HPR and HaPR) were assessed. Patients were divided into two groups according to MBG 3 or <3. RESULTS: MBG 3 was identified in 28 (46%) patients. Mean PRU was lower in such patients as compared with those with MBG <3 (155.82 ± 90.91 vs. 227.42 ± 65.18; p=0.001) while mean ARU was similar between groups. HPR and HaPR were observed in 30 (49.2%) and 11 patients (18%), respectively. HPR but not HaPR was more frequent in the group with impaired MBG (66.7 vs. 28.6%; p=0.003 and 21.2 vs. 14.3%; p=0.48 respectively). CONCLUSION: Our study shows that higher PRU and the subsequent HPR at the time of primary PCI, after pretreatment with ticagrelor, are the only correlates of post PCI MBG. These findings support the earliest possible loading with ticagrelor prior to primary PCI.

Vitamin K antagonist vs direct oral anticoagulants with antiplatelet therapy in dual or triple therapy after percutaneous coronary intervention or acute coronary syndrome in atrial fibrillation: Meta-analysis of randomized controlled trials.

BACKGROUND: The combination of vitamin K antagonists (VKA) for atrial fibrillation (AF) and antiplatelet agents following percutaneous coronary intervention (PCI) is associated with an increased bleeding risk. HYPOTHESIS: Direct oral anticoagulants (DOAC) are associated with a greater safety profile but the optimal antithrombotic treatment strategy, especially when considering ischemic events, is unclear. METHODS: We performed a meta-analysis of randomized controlled trials comparing outcomes in AF patients following PCI and/or acute coronary syndrome (ACS) when treated with DOAC vs VKA, both in combination with one (dual) or two (triple) antiplatelet regimens. A systematic review was performed by searches of electronic databases MEDLINE (source PubMed) and the Cochrane Controlled Clinical Trials Register Database as well as Cardiology annual meetings. Three studies were finally included. RESULTS: Compared to VKA triple therapy, the use of DOAC was associated with a decreased risk of any bleeding (relative risk [RR] 0.68 [0.62; 0.74]), major bleeding (RR 0.61 [0.51; 0.75]) and intracranial bleeding (RR 0.33 [0.17; 0.66]) and similar rates of the composite efficacy endpoint (RR 1.0 [0.87; 1.14]) and its components. Similar and consistent results were observed with both dual and triple therapy including a DOAC compared to VKA. CONCLUSION: Our meta-analysis supports the use of dual therapy combining a DOAC and clopidogrel as the default regimen in most AF patients after PCI and/or ACS.

Improving quality of care in patients with decompensated acute heart failure using a discharge checklist.

BACKGROUND: The use of a discharge checklist may decrease heart failure readmission rate. AIMS: We aimed to evaluate the usefulness of a checklist in patients hospitalized for heart failure, in terms of mortality, cardiovascular mortality and readmission rates, and quality of care, including therapeutic optimization and careplan planning. METHODS: We prospectively used a discharge checklist in 103 patients hospitalized for heart failure between July 2015 and January 2016. Quality of care and outcomes were compared with a retrospective cohort of 137 patients with same inclusion criteria, hospitalized between June 2014 and December 2014. The primary endpoints were total and cardiovascular mortality and readmissions for heart failure at 6months. The secondary endpoint was quality of care rendered, measured by evidence-based medications, appropriate medication uptitration and planned discharge care. RESULTS: At 6months, there were no differences between the checklist and control cohorts in the rates of all-cause mortality (10.7% vs. 13.1%; P=0.57), cardiovascular mortality (8.7% vs. 10.9%; P=0.58) and readmission (29.1% vs. 32.1%; P=0.62). Follow-up after discharge was better planned in the checklist group. The use of the checklist yielded therapeutic optimization with a higher dose of beta-blockers and renin-angiotensin-aldosterone system blockers, especially in patients with a reduced left ventricular ejection fraction (<50%) (P=0.03 and P=0.02, respectively). CONCLUSIONS: The use of a simple discharge checklist in patients with acute heart failure showed no benefit in terms of readmission and mortality rates; however, it yielded better quality of care, including therapeutic optimization and careplan planning.

Bedside mental status and outcome in elderly patients admitted for acute coronary syndromes.

OBJECTIVE: We investigated whether mental status assessed by simple bedside tests in elderly patients admitted for acute coronary syndromes (ACS) was associated with higher risk of mortality. METHODS: We used the data from a prospective, open, ongoing cohort of patients≥75 years old admitted for ACS to a tertiary centre. Cognitive impairment (CogI) was defined by delirium detected by the Confusion Assessment Method or an abnormal Mini Mental State Examination score. A Cox model adjusted on predefined correlates of mortality was used to assess the relationship between CogI and 1-year mortality. RESULTS: Six-hundred consecutive patients with mental status assessment within 48 hours after admission were included. CogI was identified in 172 (29%) patients among whom 153 (25.5%) had an abnormal Mini Mental State Evaluation and 19 (3.2%) delirium. Death occurred in 49 (28.6%) patients with and 43 (10.5%) patients without CogI at 1 year. There was a significant association between CogI and 1-year mortality (adjusted-HR 2.4, 95% CI 1.53 to 3.62), p<0.001) independent of other covariables. CogI was also independently associated with higher rates of in-hospital bleeding and mortality as well as 3-month rates of all-cause, cardiovascular-related and heart failure-related rehospitalisation. CONCLUSIONS: CogI detected by simple bedside tests in patients≥75 admitted for ACS is associated with an increased risk of 1-year mortality and 3 month rehospitalisation independent of other correlates of poor outcome.