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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. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

Background: The itAlian pRospective Study on CANGrELOr (ARCANGELO) was aimed to assess the safety of using cangrelor during percutaneous coronary intervention (PCI) in patients with acute coronary syndromes (ACS) in the daily practice. Hypothesis: The safety of cangrelor after the transition to oral P2Y12 inhibitors was evaluated as the incidence of bleeding outcomes in the 30 days following PCI according to postauthorization safety study guidelines. Methods: Adults with ACS who were treated with cangrelor in one of the 28 centers involved in the study. Patients who consented to participate were followed in the 30 days following their PCI. Bleedings (Bleeding Academic Research Consortium [BARC] classification), major adverse cardiac events (MACEs), and adverse events were recorded. The interim results at two‐thirds of the enrollment period are presented. Results: A total of 17 bleedings were observed in the 320 patients who completed the study at this stage. All bleedings were classified as BARC Type 1–2, except for one case of Type 3a (vessel puncture site hematoma). Four patients experienced MACEs (2 acute myocardial infarctions, 1 sudden cardiac death, 1 noncardiovascular death due to respiratory distress, and multiorgan failure). None of the bleedings was rated as related to cangrelor. Conclusions: The interim results of the ARCANGELO study provide a preliminary confirmation that the use of cangrelor on patients with ACS undergoing PCI is not associated with severe bleedings. [ABSTRACT FROM AUTHOR]

Aims There are limited data about the intraprocedural haemodynamic study performed immediately before and after transcatheter aortic valve implantation (TAVI) in patients with severe aortic stenosis (AS). We aimed to evaluate the acute haemodynamic impact of TAVI in patients with severe AS and to investigate invasive and non-invasive parameters predicting all-cause mortality. Methods and results A total of 245 consecutive AS patients (43% male, mean age 80.3 ± 7.3 years) undergoing TAVI were enrolled. Intraprocedural left heart catheterization (LHC) and echocardiogram before and after TAVI were performed. The clinical endpoint was the death for any cause. LHC after TAVI revealed significant changes in aortic and left ventricular (LV) pressures, including indexes of intrinsic myocardial contractility and diastolic function such as positive dP/dT (1128.9 ± 398.7 vs. 806.3 ± 247.2 mmHg/s, P ˂ 0.001) and negative dP/dT (1310.7 ± 431.1 vs. 1075.1 ± 440.8 mmHg/s, P ˂ 0.001). Post-TAVI echo showed a significant reduction in LV end-diastolic (P = 0.036) and end-systolic (P ˂ 0.001) diameters, improvement in LV ejection fraction (from 55 ± 12% to 57.2 ± 10.5%, P ˂ 0.001), and pulmonary artery systolic pressure (42.1 ± 14.2 vs. 33.1 ± 10.7 mmHg, P < 0.001). After a mean follow-up time interval of 24 months, 47 patients died. Post-TAVI significant aortic regurgitation at echocardiography was the only independent predictor of mortality (hazard ratio 5.592, confidence interval 1.932–16.184, P = 0.002). Conclusions Left heart catheterization performed immediately before and after prosthesis release offers a unique insight in the assessment of LV adaptation to severe AS and the impact of TAVI on LV, catching changes in indexes of intrinsic contractility and myocardial relaxation. Aortic regurgitation assessed by echocardiography was the only independent predictor of mortality in patients undergoing TAVI. [ABSTRACT FROM AUTHOR]

Platypnoea–orthodeoxia syndrome (POS) is an uncommon but challenging clinical condition characterised by positional dyspnoea (platypnoea) and arterial desaturation (orthodeoxia) in the upright position that improve in the supine position. Since its first description, many cases have been reported and many conditions have been associated with this syndrome. Herein, we review the clinical presentation, pathophysiology, diagnostic work‐up and management of patients with POS, aiming to increase the awareness of this often misdiagnosed condition. [ABSTRACT FROM AUTHOR]

Background Parvovirus ( PV) B19 DNA is detected in endothelial cells and may cause endothelial dysfunction, which is involved in in-stent restenosis. We aimed at performing an exploratory analysis that evaluated if PVB19 DNA at the culprit coronary stenosis would be associated with an increased rate of major adverse cardiac events ( MACE) after coronary stenting. Materials and methods Consecutive patients undergoing stent implantation for stable or unstable coronary artery disease were enroled. Serology for PVB19 infection and presence of DNA for PVB19 on balloons used for predilatation were assessed in all patients. MACE rate, as a composite of cardiac death, myocardial infarction ( MI) or clinically driven target lesion revascularization ( TLR) was obtained at 24 month follow-up. Adjusted hazard ratio ( HR) with 95% confidence interval ( CI) was calculated for variables associated with MACE. Results One hundred and nine patients [age 66 ± 10, male sex 89 (82%)] were enroled. At 24-month follow-up, 18 patients experienced a MACE. Two patients (2%) experienced MI, while 16 patients (15%) experienced clinically driven TLR. At multiple Cox regression analysis, the presence of PVB19 DNA on the balloon and the use of bare-metal stents were independent predictors of MACE [ HR 3·30, 95% CI (1·12-10·08), P = 0·03 and HR 4·19, 95% CI (1·60-10·94), P = 0·003]. Conclusions PVB19 DNA detected on the balloon used for dilatation of coronary stenosis before stent implantation is associated with MACE rate at follow-up, mainly due to clinically driven TLR. The results of this exploratory analysis should be confirmed in a larger population. [ABSTRACT FROM AUTHOR]

Aims Methods and results Conclusions Lung ultrasound (LUS) is a sensitive tool to assess pulmonary congestion (PC). Few data are available on LUS‐PC evaluation in patients with severe aortic stenosis (AS) undergoing transcatheter aortic valve implantation (TAVI). The aim of this study was to assess the prevalence and prognostic impact of LUS‐PC in patients with severe AS before and after TAVI.We designed a single‐centre prospective study in patients referred for TAVI for severe AS (ClinicalTrials.gov identification number: NCT05024942). All patients underwent echocardiography and LUS (according to a simplified 8‐zone scanning protocol) the day before and within 72 h after the procedure. The primary endpoint was the composite of all‐cause mortality, hospitalization for heart failure and urgent medical visits for worsening dyspnoea at 12‐month follow‐up. A total of 127 patients were enrolled (mean age 81.1 ± 5.8 years; 54.3% female). Pre‐TAVI LUS‐PC was documented in 65 patients (51%). After TAVI, the prevalence of LUS‐PC significantly decreased as compared to pre‐TAVI evaluation, being documented in only 28 patients (22% vs. 51%, p < 0.001) with a median B‐lines score of 4 (interquartile range [IQR] 0–11) versus 11 (IQR 6–19) pre‐TAVI (p < 0.001). During a median follow‐up of 12 (12–17) months, 25 patients (19.6%) met the composite endpoint. On multivariable Cox regression analysis, pre‐TAVI LUS‐PC was independently associated with cardiovascular events (hazard ratio 2.764, 95% confidence interval 1.114–6.857; p = 0.028).Lung ultrasonography reveals a high prevalence of PC in patients with severe AS undergoing TAVI, which is significantly reduced by the procedure. Pre‐TAVI PC, measured by LUS, is an independent predictor of 1‐year clinical outcome. [ABSTRACT FROM AUTHOR]