Novel Medical Treatments and Devices for the Management of Heart Failure with Reduced Ejection Fraction.

Heart failure (HF) is a growing issue in developed countries; it is often the result of underlying processes such as ischemia, hypertension, infiltrative diseases or even genetic abnormalities. The great majority of the affected patients present a reduced ejection fraction (≤40%), thereby falling under the name of "heart failure with reduced ejection fraction" (HFrEF). This condition represents a major threat for patients: it significantly affects life quality and carries an enormous burden on the whole healthcare system due to its high management costs. In the last decade, new medical treatments and devices have been developed in order to reduce HF hospitalizations and improve prognosis while reducing the overall mortality rate. Pharmacological therapy has significantly changed our perspective of this disease thanks to its ability of restoring ventricular function and reducing symptom severity, even in some dramatic contexts with an extensively diseased myocardium. Notably, medical therapy can sometimes be ineffective, and a tailored integration with device technologies is of pivotal importance. Not by chance, in recent years, cardiac implantable devices witnessed a significant improvement, thereby providing an irreplaceable resource for the management of HF. Some devices have the ability of assessing (CardioMEMS) or treating (ultrafiltration) fluid retention, while others recognize and treat life-threatening arrhythmias, even for a limited time frame (wearable cardioverter defibrillator). The present review article gives a comprehensive overview of the most recent and important findings that need to be considered in patients affected by HFrEF. Both novel medical treatments and devices are presented and discussed.

Recurrent events after acute ST-segment elevation myocardial infarction: predictors and features of plaque progression and stent failure.

OBJECTIVES: Patients with acute ST-segment elevation myocardial infarction (STEMI) are at high risk for recurrent coronary events (RCE). Non-culprit plaque progression and stent failure are the main causes of RCEs. We sought to identify the incidence and predictors of RCEs. METHODS: Eight hundred thirty patients with STEMI were enrolled and followed up for 5 years. All patients underwent blood test analysis at hospital admission, at 1-month and at 12-month follow-up times. Patients were divided into RCE group and control group. RCE group was further categorized into non-culprit plaque progression and stent failure subgroups. RESULTS: Among 830 patients with STEMI, 63 patients had a RCE (7.6%). At hospital admission, HDL was numerically lower in RCE group, while LDL at both 1-month and 12-month follow-up times were significantly higher in RCE group. Both HDL at hospital admission and LDL at 12-month follow-up were independently associated with RCEs (OR 0.90, 95% CI 0.81-0.99 and OR 1.041, 95% CI 1.01-1.07, respectively). RCEs were due to non-culprit plaque progression in 47.6% of cases, while in 36.5% due to stent failure. The mean time frame between pPCI and RCE was significantly greater for non-culprit plaque progression subgroup as compared to stent failure subgroup (27 ±â€…18 months and 16 ±â€…14 months, P  = 0.032). CONCLUSION: RCEs still affect patients after pPCI. Low levels of HDL at admission and high levels of LDL at 12 months after pPCI significantly predicted RCEs. A RCE results in non-culprit plaque progression presents much later than an event due to stent failure.

Cardiac Contractility Modulation Therapy in Patients with Amyloid Cardiomyopathy and Heart Failure, Case Report, Review of the Biophysics of CCM Function, and AMY-CCM Registry Presentation.

Cardiac amyloidosis may result in an aggressive form of heart failure (HF). Cardiac contractility modulation (CCM) has been shown to be a concrete therapeutic option in patients with symptomatic HF, but there is no evidence of its application in patients with cardiac amyloidosis. We present the case of TTR amyloidosis, where CCM therapy proved to be effective. The patient had a history of multiple HF hospitalizations due to an established diagnosis of wild type TTR-Amyloidosis with significant cardiac involvement. Since he was highly symptomatic, except during continuous dobutamine and diuretic infusion, it was opted to pursue CCM therapy device implantation. At follow up, a significant improvement in clinical status was reported with an increase of EF, functional status (6 min walk test improved from zero meters at baseline, to 270 m at 1 month and to 460 m at 12 months), and a reduction in pulmonary pressures. One year after device implantation, no other HF hospital admission was needed. CCM therapy may be effective in this difficult clinical setting. The AMY-CCM Registry, which has just begun, will evaluate the efficacy of CCM in patients with HF and diagnosed TTR amyloidosis to bring new evidence on its potential impact as a therapeutic option.

Long-term Results of Perfusion-Balloon Valvuloplasty, Without Rapid Pacing, in High-Risk Elderly Patients With Severe Aortic Stenosis: A New Space Oddity.

BACKGROUND: Percutaneous balloon aortic valvuloplasty (BAV) is actually recommended as a bridge to surgery or transcatheter aortic valve replacement in patients with severe aortic stenosis (AS) in particular clinical settings. In this pilot study, for the first time, we report our experience utilizing a nonocclusive balloon for BAV, which does not require rapid ventricular pacing (RVP), in high-risk symptomatic elderly patients with severe AS. METHODS AND RESULTS: From 2018 to 2020, a total of 30 high-risk elderly patients with heart failure due to severe AS were treated with BAV and were all prospectively included in the study. We used a perfusion-balloon valvuloplasty without RVP (True Flow; BD/Bard). Hemodynamic parameters were invasively evaluated during catheterization, before and immediately after BAV. All patients were regularly followed to detect the rate of mortality. The patients were 87.56 ± 4.10 years old and 23% were males. In the catheterization laboratory, the peak left ventricular to aortic pressure gradient significantly decreased from 55 mm Hg (interquartile range [IQR], 48.75-66.25) to 26 mm Hg (IQR, 15.7-30) immediately after balloon inflation (P<.001). The median value of percentage decrease of transaortic gradient was 56% (IQR, 50-74). At a median of 12 months (IQR, 5-27) follow-up, 12 patients (40%) died. The median time between BAV and mortality was 10.5 months (IQR, 1.75-15.5). At multivariable analysis, the only predictor of mortality was the New York Heart Association class at admission (odds ratio, 3.29; 95% confidence interval, 2.4-298.4; P<.01). CONCLUSION: This single-center pilot study represents the first evidence that perfusion-balloon valvuloplasty without RVP is a safe, valid, and durable option in high-risk, symptomatic, elderly patients with severe AS.

Coronary Plaque Rupture in Stable Coronary Artery Disease and Non-ST Segment Elevation Myocardial Infarction: An Optical Coherence Tomography Study.

BACKGROUND: Plaque rupture (PR) is the main cause of coronary thrombosis in non-ST segment elevation myocardial infarction (NSTEMI), but can be found in stable coronary artery disease (CAD). Our study compared the morphology and local inflammatory activity of ruptured plaques between stable CAD and NSTEMI patients using frequency-domain optical coherence tomography (FD-OCT). METHODS: We retrospectively evaluated 70 plaques with PR at the FD-OCT (25 in stable CAD patients and 45 in NSTEMI patients). Main clinical, angiographic, and morphological features were compared. RESULTS: Besides an overall equivalence in clinical and angiographic features (except for more smokers among NSTEMI patients), some important FD-OCT differences in plaque morphology emerged: PR in NSTEMI was characterized by more macrophage infiltrates (78% in NSTEMI patients vs 20% in stable CAD patients; P<.001) and intraluminal thrombosis (84% in NSTEMI patients vs 48% in stable CAD patients; P<.01). Quantitative analysis showed a higher density of macrophages in NSTEMI than in stable CAD patients: median max normalized standard deviation (NSD) was 0.0934 (IQR, 0.0796-0.1022) vs 0.0689 (IQR, 0.0598-0.0787); P<.01 and mean NSD was 0.062 (IQR, 0.060-0.065) vs 0.053 (IQR, 0.051-0.060); P<.001. Other morphological features did not differ between stable CAD and NSTEMI patients. Main FD-OCT quantitative parameters like minimal lumen area and plaque length were also equivalent between the 2 groups. CONCLUSIONS: Differences in morphological features of PR between stable CAD and NSTEMI patients suggest that local inflammation contributes to the unstable fate of the atherosclerotic plaque.

Reduction in acute coronary syndromes during coronavirus disease 2019 global pandemic: data from the Marche region of Italy.

AIMS: During the novel severe acute respiratory syndrome coronavirus 2 (coronavirus disease 2019) pandemic, a worldwide reduction in total acute coronary syndrome (ACS) has been reported. In early 2020, Italy became the most affected country and national lockdown was declared early on in March. We described trends in ACS from all the Marche coronary catheterization laboratories (CCL) during the global pandemic. METHODS: Retrospective study of all consecutive patients admitted to the four regional CCL. The coronavirus disease 2019 period (20 February 2020 to 15 April 2020) was compared with the interyear control period (1 January 2020 to 19 February 2020) and to the intrayear control period (20 February 2019 to 15 April 2019). All patients with an initial diagnosis of ACS were included in the analysis, and further stratified into ST-segment elevation myocardial infarction (STEMI) and non-STEMI (NSTEMI)/unstable angina. RESULTS: A total of 1239 patients were enrolled. Daily incidence of ACS was 6.1, 6.3 and 4.5 for the interyear control period, the intrayear control period and the case period, respectively. There was no difference in overall STEMI daily incidence while NSTEMI/unstable angina fell from 3.6 and 3.3-1.8 during the case period (P = 0.01). Incidence rate ratios were significantly lower when the case period was compared with the intrayear control period (incidence rate ratios: 0.49, 95% confidence interval 0.41-0.59, P = 0.001) and the interyear control period (incidence rate ratios: 0.67, 95% confidence interval 0.50-0.90, P = 0.008). CONCLUSION: During the global pandemic there was a significant reduction in total ACS and NSTEMI in the Marche region. Unlike previous reports, there was no difference in overall access to CCL for STEMI during the same period.

Appropriate use criteria for coronary angiography: a single centre experience.

BACKGROUND: Increasing attention is being given to the rational use of invasive procedures. In this study, we aimed to evaluate, among patients referred for coronary angiography, the appropriateness of cardiac catheterization according to the Appropriate Use Criteria (AUC) for diagnostic catheterization and to examine the relationship between the appropriateness and the presence of obstructive coronary artery disease (CAD) and revascularization. METHODS: From November 2017 to December 2018, 1188 consecutive patients referred to undergo a diagnostic catheterization were included. They were categorized as having appropriate, uncertain or inappropriate indication, using a database (Melograno System). We restricted our analysis to 9 appropriate indications including acute coronary syndromes, suspected CAD, valvular heart disease, arrhythmias and cardiomyopathy. We restricted the analysis to the subgroup of patients with suspected or known CAD and, among them, we evaluate the rate of CAD and the need for revascularization. RESULTS: The indications were appropriate in 1017 patients (85.6%), of uncertain appropriateness in 134 (11.3%), and inappropriate in 37 (3.1%). Restricting the analysis to the CAD subgroup, the indications were appropriate in 848 patients (83.3%), of uncertain appropriateness in 133 (13.1%) and inappropriate in 37 (3.6%). The proportion of patients with critical CAD were 75.9%, 44.3% and 29.7% in the appropriate, uncertain and inappropriate categories respectively (p < 0.001). The revascularization rate was 63.1%, 32.2% and 21.6% in the appropriate, uncertain and inappropriate categories respectively (p < 0.001). CONCLUSIONS: Application of AUC is feasible in a community setting. Melograno system is useful to improve patient care.

Intracoronary imaging to guide percutaneous coronary intervention: Clinical implications.

BACKGROUND: Over the last decade, the intra-coronary imaging (ICI) has emerged to guide percutaneous coronary intervention (PCI), thus overcoming the limitations of "luminology" offered by angiography. METHODS: In this review, we aim at purely focusing on the clinical implications of the employment of ICI in the routine practice, thus providing suggestions for future applications. In particular, we will describe the principal contributions and implications of ICI in the following different clinical settings: 1) assessment of clinical and imaging outcomes of PCI; 2) guiding PCI before and after stent implantation; 3) identification of mechanisms of stent failure. RESULTS: Several studies showed the capability of ICI in assessing the clinical and imaging outcomes of PCI. In particular, they have compared the ICI-guided PCI with the angiography-guided procedures, emphasizing the advantages of using imaging. Indeed, ICI can characterize the coronary plaque, provide a precise estimation of the coronary stenosis, select the appropriate method of intervention, and optimize stent deployment and lesion coverage. Finally, ICI has been shown to be useful to point out the mechanisms of stent failure. CONCLUSIONS: ICI can facilitate decision-making in patients with unclear angiographic findings, guide-selected interventions and optimize the final PCI results in complex lesions or. in high-risk patients. Finally, by the identification of specific mechanisms of stent failure, the ICI can allow to adopt a tailored therapy for the singles cases.

A patient with multiple Swiss cheese aspect coronary lesions: optical coherence tomography to guide coronary angioplasty.

Although spontaneous recanalization of coronary thrombi has been reported pathologically, it is rarely recognized in clinical practice. We presented a rare case of recanalized thrombi of the right coronary artery and distal left anterior descending artery in a patient with an anterior ST segment elevation myocardial infarction treated with primary percutaneous intervention of the proximal left anterior descending artery. Optical coherence tomography aspect of right coronary artery was consistent with a 'Swiss cheese' appearance that represented recanalization of organized thrombi. Optical coherence tomography has been essential to discriminate the underlying mechanism and may provide useful information for an appropriate treatment approach.

Effect on Clinical Restenosis of an Ultra-Thin-Strut Bare Metal Cobalt-Chromium Stent Versus a Thin-Strut Stainless Steel Stent.

OBJECTIVES: To prospectively compare the impact of ultrathin-strut cobalt-chromium (Cro-Co) bare metal stent (BMS) versus thin-strut stainless steel (SS) BMS on clinically driven target lesion revascularization (TLR). BACKGROUND: Stent characteristics are an important determinant of restenosis. Thinner strut Cro-Co BMS is associated with a reduction of neointimal formation compared to SS BMS. The advantages of Cro-Co BMS in a real-world population is not clear. METHODS: Patients undergoing percutaneous coronary intervention (PCI) with BMS for any reason were enrolled. Patient with multi-vessel PCI, multi-lesions PCI, PCI of unprotected left main and coronary grafts were not excluded. They were divided in two groups according to stent type: Cro-Co or SS group. The primary endpoint was clinically driven TLR at follow-up. RESULTS: A total of 383 patients were enrolled: 222 in SS and 161 in Cro-Co group. During the follow-up, Cro-Co patients had a significantly lower occurrence of TLR compared to SS patients (1.9% vs 8.6%, P = 0.006). There were no significant differences for the composite endpoint of death, myocardial infarct, and stroke (4.9% in Cro-Co group vs 9.5% in SS group, P = 0.119). At multivariate analysis, the variables that were predictors of TLR were: use of SS stent (OR 4.43, P = 0.019) and diabetes (OR 2.84, P = 0.025). CONCLUSIONS: Ultra-thin strut Cro-Co BMS is associated with a significant reduction of clinically driven TLR in all comers population with any type of coronary disease complexity. (J Interven Cardiol 2016;29:300-310).

Resting echocardiography for the early detection of acute coronary syndromes in chest pain unit patients.

AIM: The purpose of this study is to assess the ability of resting echocardiography to detect an acute coronary syndrome (ACS) before the occurrence of ischemic electrocardiogram (ECG) changes or troponin-T elevations. METHODS: Four hundred and three patients who presented to the emergency room (ER) with chest pain, normal ECGs, and normal troponin-T levels were admitted to the cardiologist-run Chest Pain Unit (CPU) for further monitoring. They underwent serial resting echocardiography for monitoring of left ventricle wall motion (LVWM), ECG telemetry monitoring, and serial troponin-T measurements. RESULTS: An ACS was detected in 49 patients (12.1%). These 49 patients were then subdivided into three different groups based on the initial mode of detection of their ACS. In group A, 16 of 49 (32.6%) patients had ACS shown by echocardiographic detection of LVWM abnormalities. In group B, 24 of 49 (48.9%) patients had an ACS detected by ischemic ECG changes. In group C, 9 of 49 (18.3%) patients had an ACS detected by troponin-T elevations. The shortest time interval between CPU-admission and ACS-detection occurred in group A (A vs. B, P < 0.003; A vs. C, P < 0.0001). In group A, cardiac angiogram showed that the culprit coronary lesion was more frequent in the circumflex artery (11 out of 16; 68.7%) (LCx vs. LAD, P < 0.02; LCx vs. RCA, P < 0.001) and of these 11 patients with circumflex lesions, the ECG was normal in eight (72.7%) patients. CONCLUSION: This study demonstrates the utility of LVWM monitoring by serial echocardiography as part of a diagnostic protocol that can be implemented in a CPU. Furthermore, echocardiography could become an essential tool used in the diagnosis of ACS secondary to circumflex lesions.