New technologies have been recently introduced to improve the monitoring of patients with chronic syndromes such as heart failure. Devices can now be employed to gather large amounts of data and data ...processing through artificial intelligence techniques may improve heart failure management and reduce costs. The analysis of large datasets using an artificial intelligence technique is leading to a paradigm shift in the era of precision medicine. However, the assessment of clinical safety and the evaluation of the potential benefits is still a matter of debate. In this article, the authors aim to focus on the development of these new tools and to draw the attention to their transition in daily clinical practice.
the RIGENERA trial assessed the efficacy of granulocyte-colony stimulating factor (G-CSF) in the improvement of clinical outcomes in patients with severe acute myocardial infarction. However, there ...is no evidence available regarding the long-term safety and efficacy of this treatment.
in order to evaluate the long-term effects on the incidence of major adverse events, on the symptom burden, on the quality of life and the mean life expectancy and on the left ventricular (LV) function, we performed a clinical and echocardiographic evaluation together with an assessment using the Minnesota Living with Heart Failure Questionnaire (MLHFQ) and the Seattle Heart Failure Model (SHFM) at 10-years follow-up, in the patients cohorts enrolled in the RIGENERA trial.
thirty-two patients were eligible for the prospective clinical and echocardiography analyses. A significant reduction in adverse LV remodeling was observed in G-CSF group compared to controls, 9% vs. 48% (
= 0.030). The New York Heart Association (NYHA) functional class was lower in G-CSF group vs. controls (
= 0.040), with lower burden of symptoms and higher quality of life (
= 0.049). The mean life expectancy was significantly higher in G-CSF group compared to controls (15 ± 4 years vs. 12 ± 4 years,
= 0.046. No difference was found in the incidence of major adverse events.
this longest available follow-up on G-CSF treatment in patients with severe acute myocardial infarction (AMI) showed that this treatment was safe and associated with a reduction of adverse LV remodeling and higher quality of life, in comparison with standard-of-care treatment.
Abstract
Undeployed stent loss is a rare but potentially serious complication of percutaneous coronary intervention. Its management is not assisted by well‐defined guidelines, and it is made even ...more difficult when the dislodged stent is not protected by in situ guidewire. In this work, we present the case of a total stent loss with a crushed device protruding out of the left main. In this hopeless circumstance, an innovative ping‐pong technique was used to contralaterally perform a successful stent retrieval.
Aims
Pre‐clinical congestion markers of worsening heart failure (HF) can be monitored by devices and may support the management of patients with HF. We aimed to assess whether congestion‐guided HF ...management according to device‐based remote monitoring strategies is more effective than standard therapy.
Methods and results
A comprehensive literature research for randomized controlled trials (RCTs) comparing device‐based remote monitoring strategies for congestion‐guided HF management versus standard therapy was performed on PubMed, Embase, and CENTRAL databases. Incidence rate ratios (IRRs) and associated 95% confidence intervals (CIs) were calculated using the Poisson regression model with random study effects. The primary outcome was a composite of all‐cause death and HF hospitalizations. Secondary endpoints included the individual components of the primary outcome. A total of 4347 patients from eight RCTs were included. Findings varied according to the type of parameters monitored. Compared with standard therapy, haemodynamic‐guided strategy (4 trials, 2224 patients, 12‐month follow‐up) reduced the risk of the primary composite outcome (IRR 0.79, 95% CI 0.70–0.89) and HF hospitalizations (IRR 0.76, 95% CI 0.67–0.86), without a significant impact on all‐cause death (IRR 0.93, 95% CI 0.72–1.21). In contrast, impedance‐guided strategy (4 trials, 2123 patients, 19‐month follow‐up) did not provide significant benefits.
Conclusion
Haemodynamic‐guided HF management is associated with better clinical outcomes as compared to standard clinical care.
Summary effect estimates for different strategies of guided management versus standard therapy related to pathogenesis of worsening heart failure. CI, confidence interval; IRR, incidence rate ratio.
Several implant-based remote monitoring strategies are currently tested to optimize heart failure (HF) management by anticipating clinical decompensation and preventing hospitalization. Among these ...solutions, the modern implantable cardioverter-defibrillator and cardiac resynchronization therapy devices have been equipped with sensors allowing continuous monitoring of multiple preclinical markers of worsening HF, including factors of autonomic adaptation, patient activity, and intrathoracic impedance.
We aimed to assess whether implant-based multiparameter remote monitoring strategy for guided HF management improves clinical outcomes when compared to standard clinical care.
A systematic literature research for randomized controlled trials (RCTs) comparing multiparameter-guided HF management versus standard of care was performed on PubMed, Embase, and CENTRAL databases. Incidence rate ratios (IRRs) and associated 95% confidence intervals (CIs) were calculated using the Poisson regression model with random study effects. The primary outcome was a composite of all-cause death and HF hospitalization events, whereas secondary endpoints included the individual components of the primary outcome.
Our meta-analysis included 6 RCTs, amounting to a total of 4869 patients with an average follow-up time of 18 months. Compared with standard clinical management, the multiparameter-guided strategy reduced the risk of the primary composite outcome (IRR 0.83, 95%CI 0.71–0.99), driven by statistically significant effect on both HF hospitalization events (IRR 0.75, 95%CI 0.61–0.93) and all-cause death (IRR 0.80, 95%CI 0.66–0.96).
Implant-based multiparameter remote monitoring strategy for guided HF management is associated with significant benefit on clinical outcomes compared to standard clinical care, providing a benefit on both hospitalization events and all-cause death.
Main findings of our meta-analysis: implant-based remote monitoring strategies for multiparameter-guided HF management is associated with a reduction of the composite endpoint of all-cause death and HF hospitalizations, driven by a benefit in both individual components. Display omitted
•A significant proportion of HF patients is under-managed and under-treated.•Modern ICD/CRT devices enable to remotely monitor patient parameters suggesting impending HF decompensation.•Our meta-analysis, including 4869 patients, is the first one to test the full implementation of ICD/CRT-based remote monitoring strategy to guide HF management.•This meta-analysis showed that multiparameter-guided remote monitoring strategy in HF patient reduces all-cause death and hospitalization events.•Further studies are needed to test the cost-effectiveness of such strategy.
Abstract
Background
Current guidelines recommend that patients with heart failure and a reduced ejection fraction (HFrEF) should receive four foundational treatments, i.e. renin-angiotensin system ...inhibitor (RASi) or angiotensin-receptor neprilysin inhibitor (ARNi), β-blocker, mineralocorticoid receptor antagonist (MRA) and sodium-glucose cotransporter 2 inhibitor (SGLT2i). There is emerging consensus that simultaneous initiation or rapid sequencing provide greater benefit, enhancing tolerability of these therapies and improving outcomes. However, implementation of a comprehensive approach is limited by common underuse and underdosing, and paucity of data exists on initiating the four pharmacological pillars of HFrEF during hospitalization or at discharge.
Aim
To investigate the feasibility of a comprehensive pharmacological approach in patients with HFrEF at discharge after an episode of heart failure (HF) hospitalization in a tertiary referral center.
Methods
In-patients with HFrEF and a first HF hospitalization (2019-2021) were categorized according to the number/type of treatments prescribed at discharge. Prevalence of contraindications and cautions for HFrEF treatments – as defined by current European Society of Cardiology (ESC) guidelines on HF – was as assessed. Logistic regression models were fitted to assess predictors of number of treatments prescribed and risk of re-hospitalization.
Results
Among 305 patients with HFrEF, 49.2% received at least two current recommended drugs. A β-blocker was prescribed in 93.4% of patients, and a RASi/ARNi in 68.2%. Based on current recommendations, 46.2% of patients could receive four foundational drugs. An MRA was prescribed in 32.5% of patients and 100% of patients did not show contraindications to MRA use. Renal dysfunction was present in 13.1% of patients, while hypotension in 11.8%. Bradycardia and renal dysfunction were associated with lower number of drugs prescribed adjusted OR (95% CI) 0.18 (0.06-0.50), and 0.50 (0.39-0.64), respectively. A higher number of drugs used was associated with no rehospitalization during the 30 days after discharge OR (95% CI) 0.22 (0.10-0.49) per number of pillars increase.
Conclusions
Based on the presence/absence of contraindications, a quadruple therapy could be implementable in a contemporary cohort of HFrEF in-patients at discharge. Renal dysfunction and bradycardia were the main prevalent conditions limiting the achievement of a more comprehensive therapeutic approach. Use of a higher number of drugs was associated with lower risk of re-hospitalization within 30 days after discharge.
Abstract
Background
Heart failure with preserved ejection fraction (HFpEF) represents nowadays the most frequent presentation of heart failure (HF) in patients aged > 65 years. The underlying reason ...for the failure of the vast majority of randomized controlled trials (RCTs) in HFpEF patients has been identified in the heterogeneity of pathophysiology and clinical phenotype of this clinical syndrome. Coronary microvascular dysfunction (CMD) represents one among various pathophysiological mechanisms, together with pulmonary vascular disease, pericardial restraint, impaired chronotropic reserve and abnormal autonomic tone. Whether CMD-HFpEF endotype differs from the others in terms of echocardiographic parameters and clinical outcomes is still a matter of debate. Therefore, a systematic review and meta-analysis were performed in order to compare HFpEF populations with or without CMD in terms of echocardiographic features and clinical outcomes.
Methods
We searched for articles published in PubMed, Scopus and Wiley comparing HFpEF population with or without CMD up to 1st September 2022. Observational studies, reporting echocardiographic parameters mentioned in HFA-PEFF score and/or clinical time to event data, were included. E/e’ ratio, left atrial volume index (LAVi) and left ventricular mass index (LVMi) constituted our three parameters of choice and Hedge's g was the summary effect size. The composite of HF hospitalization and all-cause death represented our clinical endpoint. Meta-regressions according to follow-up time were performed in order to explore potential heterogeneity sources across studies.
Results
We identified 9 prospective observational studies, enrolling 797 patients with HFpEF. On pooled analysis, patients with CMD present a more severe echocardiographic phenotype, determined by a higher LAVi effect size (ES) 0.40; Confidence Interval (CI) 0.11, 1.69, E/e’ ratio (ES 0.65; CI 0.28, 1.02) and LVMi (ES 0.27; CI 0.01, 0.53) compared to no-CMD patients. Furthermore, CMD patients showed a significant higher rate of the composite endpoint of all-cause-death and hospitalization for HF (HR 3.22, CI 1.2-8.5, p 0.02). At meta-regression, a significant correlation was found between logarithmic hazard ratios and follow-up time reported (z=2.03, p value 0.04), suggesting that long-term follow-up of CMD-HFpEF patients is required to track the natural trajectory of the disease.
Conclusions
Aside from being considered a pathophysiological hallmark in the development of HFpEF, CMD seems to play an aggravating role in the progression of the disease, leading both to more severe echocardiographic parameters and worse clinical outcomes compared to other endotypes. Thus, different echocardiographic thresholds could allow for a better prognostic stratification and for identifying the subset of patients who deserve a CMD assessment and who are eventually more likely to benefit from drugs targeting CMD.
Aims
In heart failure (HF), implantable haemodynamic monitoring devices have been shown to optimize therapy, anticipating clinical decompensation and preventing hospitalization. Direct left‐sided ...haemodynamic sensors offer theoretical benefits beyond pulmonary artery pressure monitoring systems. We evaluated the safety, usability, and performance of a novel left atrial pressure (LAP) monitoring system in HF patients.
Methods and results
The VECTOR‐HF study (NCT03775161) was a first‐in‐human, prospective, multicentre, single‐arm, clinical trial enrolling 30 patients with HF. The device consisted of an interatrial positioned leadless sensor, able to transmit LAP data wirelessly. After 3 months, a right heart catheterization was performed to correlate mean pulmonary capillary wedge pressure (PCWP) with simultaneous mean LAP obtained from the device. Remote LAP measurements were then used to guide patient management. The miniaturized device was successfully implanted in all 30 patients, without acute major adverse cardiac and neurological events (MACNE). At 3 months, freedom from short‐term MACNE was 97%. Agreement between sensor‐calculated LAP and PCWP was consistent, with a mean difference of −0.22 ± 4.92 mmHg, the correlation coefficient and the Lin's concordance correlation coefficient values were equal to 0.79 (p < 0.0001) and 0.776 (95% confidence interval 0.582–0.886), respectively. Preliminary experience with V‐LAP‐based HF management was associated with significant improvements in New York Heart Association (NYHA) functional class (32% of patients reached NYHA class II at 6 months, p < 0.005; 60% of patients at 12 months, p < 0.005) and 6‐min walk test distance (from 244.59 ± 119.59 m at baseline to 311.78 ± 129.88 m after 6 months, p < 0.05, and 343.95 ± 146.15 m after 12 months, p < 0.05).
Conclusion
The V‐LAP™ monitoring system proved to be generally safe and provided a good correlation with invasive PCWP. Initial evidence also suggests possible improvement in HF clinical symptoms.
VECTOR‐HF trial highlights. 6MWT, 6‐min walk test; FUP, follow‐up; HF, heart failure; LAP, left atrial pressure; LVEF, left ventricular ejection fraction; M, months; MACNE, major adverse cardiac and neurological event; (NT‐pro‐)BNP, (N‐terminal pro‐)B‐type natriuretic peptide; NYHA, New York Heart Association; PCWP, pulmonary capillary wedge pressure; RHC, right heart catheterization.
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