PrOgnosis in Pulmonary Embolism (PoPE): 30-Day mortality risk score based on five admission parameters.

INTRODUCTION AND OBJECTIVE: Several scoring systems have been developed for risk stratification in patients with acute pulmonary embolism (PE). The Pulmonary Embolism Severity Index (PESI) and its simplified version (sPESI) are among the most used, however the high number of variables hinder its application. Our aim was to derive an easy-to-perform score based on simple parameters obtained at admission to predict 30-day mortality in acute PE patients. METHODS: Retrospective study in 1115 patients with acute PE from two institutions (derivation cohort n=835, validation cohort n=280). The primary endpoint was all-cause mortality at 30 days. Statistically and clinically relevant variables were selected for multivariable Cox regression analysis. We derived and validated a multivariable risk score model and compared to other established scores. RESULTS: The primary endpoint occurred in 207 patients (18.6%). Our model included five variables weighted as follows: modified shock index ≥1.1 (hazard ratio [HR] 2.57, 1.68-3.92, p<0.001), active cancer (HR 2.27, 1.45-3.56, p<0.001), altered mental state (HR 3.82, 2.50-5.83, p<0.001), serum lactate concentration ≥2.50 mmol/L (HR 5.01, 3.25-7.72, p<0.001), and age ≥80 years (HR 1.95, 1.26-3.03, p=0.003). The prognostic ability was superior to other scores (area under curve [AUC] 0.83 [0.79-0.87] vs 0.72 [0.67-0.79] in PESI and 0.70 [0.62-0.75] in sPESI, p<0.001) and its performance in the validation cohort was deemed good (73 events in 280 patients, 26.1%, AUC=0.76, 0.71-0.82, p<0.0001) and superior to other scores (p<0.05). CONCLUSIONS: The PoPE score (https://tinyurl.com/ybsnka8s) is an easy tool with superior performance to predict early mortality in patients admitted for PE with non-high-risk PE.

SparkleMap-based left atrial flutter mapping and ablation.

Ablation of atypical left atrial flutters (LAF) is very challenging due to the complexity of the underlying atrial substrate and diverse arrhythmia mechanisms. The interpretation of the arrhythmia mechanism is usually difficult, even using advanced three-dimensional (3D) mapping systems. SparkleMap is a novel mapping algorithm that displays each electrogram as a green dot that lights up at the point corresponding to the local activation time, superimposed either on the substrate or the local activation time 3D-maps. It is not affected by the setting of the "window of interest" and there is no need for user post-processing. We present the case of patient with a persistent atypical LAF in whom we tested the concept of complex arrhythmia interpretation exclusively based on the analysis of the substrate and evaluation of SparkleMap-derived wavefront propagation. We describe the workflow for map collection and the systematic approach for arrhythmia interpretation that resulted in the identification of a dual loop perimitral mechanism with a common slow conducting isthmus inside a scar at the septum/anterior atrial wall. This new method of analysis enabled the use of a specifically targeted and precise approach for ablation, with restoration of sinus rhythm within five seconds of radiofrequency application. After 18 months of follow-up, the patient remains free from recurrences, without anti-arrhythmic medication. This case report exemplifies how helpful new mapping algorithms can be in the interpretation of the arrhythmia mechanism in patients with complex LAF. It also suggests an innovative workflow to integrate the SparkleMap into the mapping approach.

Effectiveness and Safety of Sacubitril/Valsartan in Patients with Chronic Kidney Disease-A Real-World Experience.

BACKGROUND: data regarding the effectiveness and safety of sacubitril/valsartan in heart failure and reduced ejection fraction (HFrEF) patients with chronic kidney disease (CKD) are scarse. OBJECTIVE: to evaluate the effectiveness and safety of sacubitril/valsartan in HFrEF and CKD in a real-world population. METHODS: we included consecutive ambulatory HFrEF patients that initiated sacubitril/valsartan between February 2017 and October 2020, stratified by CKD (KDIGO stage 5 excluded). PRIMARY OUTCOMES: the incidence rate per 100 patient-years and the annualized length of stay (LOS) of acute decompensated HF hospitalizations (HFH). SECONDARY OUTCOMES: all-cause mortality, NYHA improvement, and titration of sacubitril/valsartan. RESULTS: We included 179 patients, 77 with CKD, those being older (72 ± 10 vs. 65 ± 12 years, p < 0.001), had higher NT-proBNP (4623 ± 5266 vs. 1901 ± 1835 pg/mL, p < 0.001), and high anaemia incidence (p < 0.001). After 19 ± 11 months, a significant reduction in HFH adjusted incidence rate (57.5% decrease in CKD vs. 74.6%, p = 0.261) was observed, with 5 days there was a reduction in annualized LOS in both groups (p = 0.319). NYHA improved similarly in both groups (p = 0.670). CKD patients presented non-significant higher all-cause mortality (HR = 2.405, 95%CI: [0.841; 6.879], p = 0.102). Both groups had similar sacubitril/valsartan maximum dose achievement and drug withdrawal. CONCLUSION: sacubitril/valsartan was effective on reducing HFH and LOS without affecting all-cause mortality in a CKD real-world population.

Impact of different activation wavefronts on ischemic myocardial scar electrophysiological properties during high-density ventricular tachycardia mapping and ablation.

INTRODUCTION: Scar-related ventricular tachycardia (VT) usually results from an underlying reentrant circuit facilitated by anatomical and functional barriers. The later are sensitive to the direction of ventricular activation wavefronts. We aim to evaluate the impact of different ventricular activation wavefronts on the functional electrophysiological properties of myocardial tissue. METHODS: Patients with ischemic heart disease referred for VT ablation underwent high-density mapping using Carto®3 (Biosense Webster). Maps were generated during sinus rhythm, right and left ventricular pacing, and analyzed using a new late potential map software, which allows to assess local conduction velocities and facilitates the delineation of intra-scar conduction corridors (ISCC); and for all stable VTs. RESULTS: In 16 patients, 31 high-resolution substrate maps from different ventricular activation wavefronts and 7 VT activation maps were obtained. Local abnormal ventricular activities (LAVAs) were found in VT isthmus, but also in noncritical areas. The VT isthmus was localized in areas of LAVAs overlapping surface between the different activation wavefronts. The deceleration zone location differed depending on activation wavefronts. Sixty-six percent of ISCCs were similarly identified in all activating wavefronts, but the one acting as VT isthmus was simultaneously identified in all activation wavefronts in all cases. CONCLUSION: Functional based substrate mapping may improve the specificity to localize the most arrhythmogenic regions within the scar, making the use of different activation wavefronts unnecessary in most cases.

Novel "late potential map" algorithm: Abnormal potentials and scar channels detection for ventricular tachycardia ablation.

BACKGROUND: Automated systems for substrate mapping in the context of ventricular tachycardia (VT) ablation may annotate far-field rather than near-field signals, rendering the resulting maps hard to interpret. Additionally, quantitative assessment of local conduction velocity (LCV) remains an unmet need in clinical practice. We evaluate whether a new late potential map (LPM) algorithm can provide an automatic and reliable annotation and localized bipolar voltage measurement of ventricular electrograms (EGMs) and if LCV analysis allows recognizing intrascar conduction corridors acting as VT isthmuses. METHODS: In 16 patients referred for scar-related VT ablation, 8 VT activation maps and 29 high-resolution substrate maps from different activation wavefronts were obtained. In offline analysis, the LPM algorithm was compared to manually annotated substrate maps. Locations of the VT isthmuses were compared with the corresponding substrate maps in regard to LCV. RESULTS: The LPM algorithm had an overall/local abnormal ventricular activity (LAVA) annotation accuracy of 94.5%/81.1%, which compares to 83.7%/23.9% for the previous wavefront algorithm. The resultant maps presented a spatial concordance of 88.1% in delineating regions displaying LAVA. LAVA median localized bipolar voltage was 0.22 mV, but voltage amplitude assessment had modest accuracy in distinguishing LAVA from other abnormal EGMs (area under the curve: 0.676; p < .001). LCV analysis in high-density substrate maps identified a median of two intrascar conduction corridors per patient (interquartile range: 2-3), including the one acting as VT isthmus in all cases. CONCLUSION: The new LPM algorithm and LCV analysis may enhance substrate characterization in scar-related VT.

Heart and brain interactions in heart failure: Cognition, depression, anxiety, and related outcomes.

BACKGROUND: Cognitive impairment, anxiety and depression are common in heart failure (HF) patients and its evolution is not fully understood. OBJECTIVES: To assess the cognitive status of HF patients over time, its relation to anxiety and depression, and its prognostic impact. METHODS: Prospective, longitudinal, single center study including patients enrolled in a structured program for follow-up after hospital admission for HF decompensation. Cognitive function, anxiety/depression state, HF-related quality of life (QoL) were assessed before discharge and during follow-up (between 6th and 12th month) using Montreal Cognitive Assessment (MoCA), Hospital Anxiety and Depression Scale (HADS) and Kansas City Cardiomyopathy Questionnaire, respectively. HF related outcomes were all cause readmissions, HF readmissions and the composite endpoint of all-cause readmissions or death. RESULTS: 43 patients included (67±11.3 years, 69% male); followed-up for 8.2±2.1 months. 25.6% had an abnormal MoCA score that remained stable during follow-up (22.6±4.2 vs. 22.2±5.5; p=NS). MoCA score <22 at discharge conferred a sixfold greater risk of HF readmission [HR=6.42 (1.26-32.61); p=0.025], also predicting all-cause readmissions [HR=4.00 (1.15-13.95); p=0.03] and death or all-cause readmissions [HR=4.63 (1.37-15.67); p=0.014]. Patients with higher MoCA score showed a greater ability to deal with their disease (p=0.038). At discharge, 14% and 18.6% had an abnormal HADS score for depression and anxiety, respectively, which remained stable during follow-up and was not related to MoCA. CONCLUSIONS: Cognitive function, anxiety and depressive status remain stable in HF patients despite optimized HF therapy. Cognitive status shall be routinely screened to adopt attitudes that improve management as it has an impact on HF-related QoL and prognosis.

Anticoagulation after typical atrial flutter ablation: Systematic review and meta-analysis.

BACKGROUND: Cavotricuspid isthmus (CTI) ablation in typical atrial flutter (AFL) restores sinus rhythm in 95% of patients, which may lead to the discontinuation of oral anticoagulation during follow-up. Therefore, we aimed to systematically review the clinical impact of oral anticoagulation in the incidence of thromboembolic events (TE) after typical AFL ablation. METHODS: We searched for controlled studies evaluating the impact of anticoagulation in the incidence of TE in patients submitted to AFL ablation in MEDLINE, CENTRAL, PsycINFO database (June/2021). The primary outcome was TE events (ischemic stroke or systemic embolism). A meta-analysis was performed deriving risk ratios (RR) and 95% confidence intervals (CI). Statistical heterogeneity was measured through I2 metric. The confidence in the evidence was appraised with Grading of Recommendations Assessment, Development and Evaluation (GRADE) framework. RESULTS: Eight observational studies with 4870 patients were included. TE events were not significantly reduced (RR 1.18, 95% CI 0.59-2.36; n = 4870; GRADE very low). A meta-regression showed that for each 10% increase in the prevalence of previous AF in the studied population, anticoagulation reduced TE risk in 32%. There were no significant differences regarding bleeding events (RR 2.16, 95% CI 0.43-10.97, I2  = 0%; GRADE low), but there was a lower all-cause mortality (RR 0.24, 95% CI 0.17-0.32, GRADE low). CONCLUSION: The best available evidence lacks robustness and the data did not definitely associate anticoagulation after typical AFL ablation with reduced TE.

Clinical impact of MultiPoint pacing in responders to cardiac resynchronization therapy.

BACKGROUND: Cardiac resynchronization therapy demonstrated benefits in heart failure. However, only 60-70% are responders and only 22% are super-responders. MultiPoint pacing (MPP) improves structural remodeling, but data in responder patients is scarce. METHODS: A prospective, randomized study of the efficacy of MPP was conducted in patients who were CRT responders after 6 months of bi-ventricular (BiV) therapy. At 6 months, responder patients (LV end-systolic volume [LVESV] reduction ≥15%) were randomized to either continued BiV therapy or to MPP programmed with wide anatomical separation ≥30 mm, and followed until 12 months. Efficacy was determined by 6-12 month changes in LVESV and LV ejection fraction (LVEF). Evaluations of super-responder rate (LVESV reduction ≥30%) and quality of life (NYHA, EQ-5D, MLHFQ) were also performed. RESULTS: From February 2017 to February 2019, 73 CRTs with Quartet LV leads were implanted (42.9% female, 65.7 ± 10.8 years old, 79.5% dilated cardiomyopathy). At 6 months, 74.2% responded to BiV and were randomized to BiV (n = 25) or MPP (n = 24). MPP versus BiV delivered greater LVESV improvement (8.3% decrease in MPP vs. 10.3% increase in BiV patients, p = .047), greater increase in LVEF (7.7% vs. 1.8%, p = .008), and higher 0-12 month super-responder rate (86.4% vs. 56.0%, p = .027). More MPP vs. BiV patients experienced an improvement in NYHA (84.6% vs. 50.0%, p = .047) and EQ-5D (94.4% vs. 54.0%, p = .006). CONCLUSIONS: MPP with wide anatomical spacing in CRT responder patients resulted in improved LV reverse remodeling with higher rates of super-responders, and better quality of life metrics.

When the lead extractor becomes the assistant for new lead implant.

With the increasing number of cardiovascular implantable electronic device upgrade and vein obstruction caused by previous leads, it is important to have alternative techniques to upgrade the device with the maintenance of functioning leads. We report an 83-year old male with 13-year old one-lead dual-chamber pacemaker, ischemic cardiac disease and pre-dialytic chronic kidney disease submitted to an upgrade to cardiac resynchronization therapy. A sub-occlusion in the transition of left brachiocephalic vein and the superior vena cava was documented. Re-permeabilization was only achieved with a TightRail™ rotating dilator sheath over a guidewire with successful left ventricle lead implant.

Radiofrequency catheter ablation of ventricular tachycardia in ischemic heart disease in light of current practice: a systematic review and meta-analysis of randomized controlled trials.

PURPOSE: Ventricular tachycardia (VT) is a frequent cause of mortality and morbidity in patients with ischemic heart disease (IHD). We aim to perform a systematic review and meta-analysis of randomized controlled trials (RCT) of radiofrequency catheter ablation (RCA) of VT in patients with IHD and to discuss its appropriate timing and limitations. METHODS: Literature searches of MEDLINE, CENTRAL, the Cochrane Database of Systematic Reviews, Health Technology Assessment, and PsycINFO were performed in February 2020. RCTs comparing RCA vs conventional management for VT in patients with IHD and previous or planned implantable cardioverter defibrillator (ICD) were identified. Clinical outcomes included all-cause mortality, cardiovascular mortality, cardiovascular hospitalization, VT storm, recurrent VT/ventricular fibrillation (VF), appropriate ICD therapies, and appropriate ICD shocks. Using a random-effects model, relative risk (RR) and 95% confidence intervals (CI) were calculated for each outcome. RESULTS: A total of 6 RCTs (N = 791) met inclusion criteria. RCA was associated with significantly lower VT storm (RR 0.70; CI95% 0.51 to 0.94, p = 0.02) and appropriate ICD therapies (RR 0.69; CI95% 0.54 to 0.88, p = 0.003), including appropriate ICD shocks (RR 0.66; CI95% 0.47 to 0.92, p = 0.02). There was no significant difference in all-cause or cardiovascular mortality, cardiovascular hospitalization, and recurrent VT/VF. CONCLUSIONS: Radiofrequency catheter ablation for VT in patients with IHD was associated with a reduced risk of VT storm, ICD therapies, and ICD shocks. There is a need for future carefully designed RCTs that incorporate improved RCA procedural aspects.

Non-invasive telemonitoring improves outcomes in heart failure with reduced ejection fraction: a study in high-risk patients.

AIMS: Non-invasive telemonitoring (TM) in patients with heart failure (HF) and reduced left ventricular ejection fraction (HFrEF) may be useful in the early diagnosis of HF decompensation, allowing therapeutic optimization and avoiding re-hospitalization. We describe a TM programme in this population and evaluate its effectiveness during a 12 month period. METHODS AND RESULTS: We conducted a single-centre study of patients discharged from hospital after decompensated HF, allocated into three groups: prospective TM programme, prospective HF protocol follow-up programme (PFP) with no TM facilities, and retrospective propensity-matched usual care (UC). TM effectiveness was assessed by all-cause hospitalizations and mortality; HF-related hospitalization (HFH), days lost to unplanned hospital admissions/death, functional capacity and quality of life (New York Heart Association, Kansas City Cardiomyopathy Questionnaire, 6 min walk test, and plasma N-terminal pro-brain natriuretic peptide) were also evaluated. A total of 125 patients were included [65.9 ± 11.9 years, 32% female, left ventricular ejection fraction 27% (21-32)]. TM was similar to PFP regarding effectiveness; TM reduced all-cause hospitalization and mortality (HR 0.27; 95% CI 0.11-0.71; P < 0.01) and HFH (HR 0.29; 95% CI 0.10-0.89; P < 0.05) as compared with UC. TM reduced the average number of days lost due to unplanned hospital admissions or all-cause death as compared with PFP (5.6 vs. 12.4 days, P < 0.05) and UC (5.6 vs. 48.8 days, P < 0.01). Impact on quality of life was similar between TM and PFP (P = 0.36). CONCLUSIONS: In patients with HFrEF and recent HF hospitalization, non-invasive TM reduced 12 month all-cause hospitalization/mortality and HFH as compared with usual care. TM also reduced the number of days lost due to unplanned hospital admission/death as compared with either an optimized protocol-based follow-up programme or usual care.

Modified snare technique improves left ventricular lead implant success for cardiac resynchronization therapy.

BACKGROUND: Left ventricular (LV) lead placement is the most challenging aspect of cardiac resynchronization therapy (CRT) device implantation, with a failure rate of up to 10% due to complex coronary anatomies. We describe a modified snare technique for LV lead placement and evaluate its safety and efficacy in cases when standard methods fail. METHODS AND RESULTS: A prospective study was conducted of patients indicated for a CRT implant. When LV lead delivery to the target vessel failed using standard techniques, a modified snare technique was employed. Patients were evaluated every 6 months. From 2015 to 2019, 566 CRTs were implanted (26.1% female, 72 ± 10.2 years old, follow-up duration 18.9 ± 15.8 months). The standard LV implant technique failed in 94 cases (16.6%), of which the modified snare technique was successful in 92 (97.9%). There were no differences between the modified snare and standard techniques in the rates of 30-day postimplant CRT all-cause mortality (3.2% vs. 1.7%, p = .33), 4-year all-cause mortality (15.9% vs. 15.5%, p = .49), or major acute complications (7.4% vs. 3.8%, p = .12). However, the 4-year procedural reintervention rate was lower with the modified snare technique (3.2% vs. 10.2%, p < .05), specifically LV implant failure or dislodgement rates (0% vs. 5.3%, p < .05), improving the response rate (71.8% vs. 55.1%, p < .05). CONCLUSIONS: For challenging coronary sinus anatomies that preclude LV lead placement by standard methods, this modified snare alternative was safe and effective, with comparable mortality and complications, but significantly lower procedural reintervention and higher response rates.

Angiotensin-converting enzyme inhibitors and angiotensin-receptor blockers and the risk of COVID-19 infection or severe disease: Systematic review and meta-analysis.

OBJECTIVE: Animal studies suggested that angiotensin-converting enzyme inhibitors (ACEi) and angiotensin-receptor blockers (ARB) facilitate the inoculation of potentially leading to a higher risk of infection and/or disease severity. We aimed to systematically evaluate the risk of COVID-19 infection and the risk of severe COVID-19 disease associated with previous exposure to (ACEi) and/or ARB). METHODS: MEDLINE, CENTRAL, PsycINFO, Web of Science Core Collection were searched in June 2020 for controlled studies. Eligible studies were included and random-effects meta-analyses were performed. The estimates were expressed as odds ratios (OR) and 95% confidence intervals (95%CI). Heterogeneity was assessed with I2 test. The confidence in the pooled evidence was appraised using the GRADE framework. RESULTS: Twenty-seven studies were included in the review. ACEi/ARB exposure did not increase the risk of having a positive test for COVID-19 infection (OR 0.99, 95%CI 0.89-1.11; I2 = 36%; 5 studies, GRADE confidence moderate). The exposure to ACEi/ARB did not increase the risk of all-cause mortality among patients with COVID-19 (OR 0.91, 95%CI 0.74-1.11; I2 = 20%; 17 studies; GRADE confidence low) nor severe/critical COVID-19 disease (OR 0.90, 95%CI 0.74-1.11; I2 = 55%; 17 studies; GRADE confidence very low). Exploratory analyses in studies enrolling hypertensive patients showed a association of ACEi/ARB with a significant decrease of mortality risk. CONCLUSIONS: ACEi/ARB exposure does not seem to increase the risk of having the SARS-CoV-2 infection or developing severe stages of the disease including mortality. The potential benefits observed in mortality of hypertensive patients reassure safety, but robust studies are required to increase the confidence in the results.

Omalizumab induced Takotsubo syndrome: case report.

BACKGROUND: Omalizumab is a humanized monoclonal anti-immunoglobulin E antibody, approved for the treatment of spontaneous chronic urticaria, with high efficacy and an excellent safety profile. Although its adverse effects are rare, allergic reactions and cardiovascular events were previously described. CASE SUMMARY: The authors describe the case of a 75-year-old woman, followed at the outpatient dermatology clinic due to spontaneous chronic urticaria, treated with omalizumab 300 mg every 4 weeks. After the 11th administration of omalizumab, the patient developed an episode of thoracalgia associated with electro- and echocardiographic abnormalities. Coronary angiogram excluded coronary artery disease, and left ventriculography demonstrated mid-apical akinesia and basal hyperkinesia, consistent with the Takotsubo syndrome (TS). DISCUSSION: Takotsubo syndrome was already reported in association with other monoclonal antibodies. However, to our knowledge, this is the first case of TS following the administration of omalizumab.

Morphine in acute coronary syndrome: systematic review and meta-analysis.

OBJECTIVE: Morphine is frequently used in acute coronary syndrome (ACS) due to its analgesic effect, it being recommended in the main cardiology guidelines in Europe and the USA. However, controversy exists regarding its routine use due to potential safety concerns. We conducted a systematic review of randomised-controlled trials (RCTs) and observational studies to synthesise the available evidence. DESIGN: Systematic review and meta-analysis. DATA SOURCES: CENTRAL, MEDLINE, EMBASE and trial registries. ELIGIBILITY CRITERIA FOR SELECTING STUDIES: We included RCTs and observational studies evaluating the impact of morphine in cardiovascular outcomes or platelet reactivity measures. DATA EXTRACTION AND SYNTHESIS: Data were screened, extracted and appraised by two independent reviewers. The data were pooled results using a random-effects model. Outcomes included in-hospital mortality, major adverse cardiovascular events (MACE), platelet reactivity (using VerifyNow) and bleeding, reported as relative risk (RR) with 95% CI. We assessed the confidence in the evidence using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) framework. We followed the Meta-analysis Of Observational Studies in Epidemiology and Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. RESULTS: Five RCTs and 12 observational studies were included, enrolling 69 993 participants. Pooled results showed an increased risk of in-hospital mortality (RR 1.45 [95% CI 1.10 to 1.91], low GRADE confidence), MACE (RR 1.21, 95% CI 1.02 to 1.45) and an increased platelet reactivity at 1 and 2 hours (59.37 platelet reactivity units [PRU], 95% CI 36.04 to 82.71; 68.28 PRU, 95% CI 37.01 to 99.55, high GRADE confidence) associated with morphine. We found no significant difference in the risk of bleeding. We found no differences in subgroup analyses based on study design and ACS subtype. CONCLUSIONS: Morphine was associated with an increased risk of in-hospital mortality and MACE but the high risk of bias leads to low result confidence. There is high confidence that morphine decreases the antiplatelet effect of P2Y12 inhibitors. PROSPERO REGISTRATION NUMBER: CRD42016036357.

Non-vitamin K antagonist oral anticoagulants in elderly patients with atrial fibrillation: A systematic review with meta-analysis and trial sequential analysis.

BACKGROUND: Elderly population is known to be associated with polymedication, comorbidities and altered drug pharmacokinetics. However, the most adequate oral anticoagulant, attending to its relative efficacy and safety, remains unclear. METHODS: We searched for phase III randomized controlled trials (MEDLINE, Cochrane Library, SciELO collection and Web of Science) comparing novel non-vitamin K antagonist oral anticoagulants (NOACs) with Vitamin K antagonists (VKA) in the elderly population (≥75 years-old) in atrial fibrillation (AF). Risk ratios (RR) were calculated using a random effects model. Trial sequential analysis (TSA) was performed in statistically significant results to evaluate whether cumulative sample size was powered. RESULTS: Four trials rendered data about elderly (≥75 years-old) and younger patients (<75 years-old) with AF. NOACs demonstrated a 30% significant risk reduction (RR 0.70, 95% CI: 0.61 to 0.80) in elderly patients compared to VKA, without heterogeneity across studies (I2 = 0%). The TSA showed that cumulative evidence of this subgroup exceeded the minimum information size required for the risk reduction. In younger patients, VKA and NOACs shared a similar risk of stroke and systemic embolism (RR 0.97, 95% CI: 0.79 to 1.18). Regarding major bleeding risk in the elderly, the overall comparative risk of NOACs was not different from VKA (RR 0.91, 95% CI: 0.72 to 1.16; I2 = 86%). CONCLUSIONS: NOACs reduce significantly the risk of stroke and systemic embolism in elderly patients without increasing major bleeding events. The dimension of stroke risk reduction was significantly higher in the elderly than in younger adults.

Protocol-based follow-up program for heart failure patients: Impact on prognosis and quality of life.

INTRODUCTION: Heart failure is associated with high rates of readmission and mortality, and there is a need for measures to improve outcomes. This study aims to assess the impact of the implementation of a protocol-based follow-up program for heart failure patients on readmission and mortality rates and quality of life. METHODS: A quasi-experimental study was performed, with a prospective registry of 50 consecutive patients discharged after hospitalization for acute heart failure. The study group was followed by a cardiologist at days 7-10 and the first, third, sixth and 12th month after discharge, with predefined procedures. The control group consisted of patients hospitalized for heart failure prior to implementation of the program and followed on a routine basis. RESULTS: No significant differences were observed between the two groups regarding mean age (67.1±11.2 vs. 65.8±13.4 years, p=0.5), NYHA functional class (p=0.37), or median left ventricular ejection fraction (27% [19.8-35.3] vs. 29% [23.5-40]; p=0.23) at discharge. Mean follow-up after discharge was similar (11±5.3 vs. 10.9±5.5 months, p=0.81). The protocol-based follow-up program was associated with a significant reduction in all-cause readmission (26% vs. 60%, p=0.003), heart failure readmission (16% vs. 36%, p=0.032), and mortality (4% vs. 20%, p=0.044). In the study group there was a significant improvement in all quality of life measures (p<0.001). CONCLUSION: A protocol-based follow-up program for patients with heart failure led to a significant reduction in readmission and mortality rates, and was associated with better quality of life.