Eligibility for vericiguat in a real-world, contemporary heart failure population.

AIMS: Vericiguat is a soluble guanylate cyclase stimulator and improves survival in patients with heart failure (HF) with reduced ejection fraction (HFrEF) and an increased risk of decompensation. As real-world data on how many patients could be eligible for vericiguat therapy derive from outdated registries, we aimed to assess eligibility in a prospective cohort of patients with HF. METHODS AND RESULTS: Data from consecutive HF patients undergoing an elective ambulatory visit at five university hospitals from 3 July to 28 July 2023 were collected. Independent investigators assessed which patients (i) met the eligibility criteria of the VICTORIA trial, (ii) complied with HF guideline recommendations, (iii) met regulatory agency criteria, or (iv) met criteria for refundability according to the Italian regulatory agency. Patients (n = 346, 72% men, median age 69 years) had HFrEF in 57% of cases, left ventricular ejection fraction < 45% in 68%, and New York Heart Association class II-IV symptoms in 76%. Patients meeting the eligibility criteria of the VICTORIA trial or European and American HF Guideline recommendations were 9% and 13%, respectively. Patients meeting Food and Drug Administration (FDA) or European Medicines Agency (EMA) label criteria were 19% and 17%, respectively. Drug costs would be covered by the Italian National Health System in 10% of patients [if a sodium-glucose cotransporter-2 inhibitor (SGLT2i) is not mandatory] or in 8% (if an SGLT2i is requested). CONCLUSIONS: In a real-world study, 9% of patients met the eligibility criteria of the VICTORIA trial, but up to 13% complied with guideline recommendations and up to 19% met FDA or EMA criteria. In Italy, drug costs would be covered by up to 10% of patients.

Impact of Bifurcation Involvement and Location in Chronic Total Occlusion Percutaneous Coronary Intervention: Insights From the EuroCTO Registry.

Bifurcation involvement close to or within the occluded segment poses increasing difficulties for chronic total occlusion (CTO)-percutaneous coronary intervention (PCI). However, this variable is not considered in the angiography-based CTO scoring systems nor has been extensively investigated in large multicenter series. Accordingly, we analyzed a CTO-PCI registry involving 92 European centers to explore the incidence, angiographic and procedural characteristics, and outcomes specific to CTO-PCIs with bifurcation involvement. A total of 3,948 procedures performed between January and November 2023 were examined (33% with bifurcation involvement). Among bifurcation lesions, 38% and 37% were located within 5 mm of the proximal and distal cap, respectively, 16% within the CTO body, and in 9% of cases proximal and distal bifurcations coexisted. When compared with lesions without bifurcation involvement, CTO bifurcation lesions had higher complexity (J-CTO 2.33 ± 1.21 vs 2.11 ± 1.27, p <0.001) and were associated with higher use of additional devices (dual-lumen microcatheter in 27.6% vs 8.4%, p <0.001, and intravascular ultrasound in 32.2% vs 21.7%, p <0.001). Radiation dose (1,544 [836 to 2,819] vs 1,298.5 [699.1 to 2,386.6] mGy, p <0.001) and contrast volume (230 [160 to 300] vs 190 [130 to 250] ml, p <0.001) were also higher. Technical success was similar (91.5% with bifurcation involvement vs 90.4% without bifurcation involvement, p = 0.271). However, the bifurcation lesions within the CTO segment (intralesion) were associated with lower technical success than the other bifurcation-location subgroups (83.7% vs 93.3% proximal, 93.4% distal, and 89.0% proximal and distal, p <0.001). On multivariable analysis, the presence of an intralesion bifurcation was independently associated with technical failure (odds ratio 2.04, 95% confidence interval 1.24 to 3.35, p = 0.005). In conclusion, bifurcations are present in approximately one-third of CTOs who underwent PCI. PCI of CTOs with bifurcation can be achieved with high success rates except for bifurcations within the occluded segment, which were associated with higher technical failure.

Determinants of health status in older patients with transthyretin cardiac amyloidosis: a prospective cohort study.

BACKGROUND: Whether, and to what extent, frailty and other geriatric domains are linked to health status in patients with transthyretin cardiac amyloidosis (ATTR-CA) is unknown. AIMS: To determine the association of frailty with health status [defined by the Kansas City Cardiomyopathy Questionnaire (KCCQ)] in patients with ATTR-CA. METHODS: Consecutive ATTR-CA patients undergoing cardiovascular assessment at a tertiary care clinic from September 2021 to September 2023 were invited to participate. KCCQ, frailty and social environment were recorded. Frailty was assessed using the modified Frailty Index (mFI), mapping 11 variables from the Canadian Study of Health and Aging (frailty ≥0.36). RESULTS: Of 168 screened ATTR-CA patients, 138 [83% men, median age of 79 (75-84) years] were enrolled in the study. Median KCCQ was 66 (50-75). wtATTR-CA was the most prevalent form (N = 113, 81.9%). The most frequent cardiac variant was Ile68Leu (17/25 individuals with vATTR-CA). Twenty (14.5%) patients were considered frail, and prevalence of overt disability was 6.5%. At multivariable linear regression analysis, factors associated with worsening KCCQ were age at evaluation, the mFI, NYHA Class, and NAC Score. Gender, ATTR-CA type, phenotype, and LVEF were not associated with health status. DISCUSSION: In older patients diagnosed with ATTR-CA, frailty, symptoms, and disease severity were associated with KCCQ. CONCLUSIONS: Functional status is a determinant of quality of life and health status in older individuals with a main diagnosis of ATTR-CA. Future research may provide more in-depth knowledge on the association of frailty in patients with ATTR-CA with respect to quality of life and prognosis.

Contrast-Induced Acute Kidney Injury in Patients with Heart Failure on Sodium-Glucose Cotransporter-2 Inhibitors Undergoing Radiocontrast Agent Invasive Procedures: A Propensity-Matched Analysis.

(1) Background: This single-center retrospective study aimed to evaluate whether sodium-glucose cotransporter-2 inhibitors (SGLT2-i) therapy may have a nephroprotective effect to prevent contrast-induced acute kidney injury (CI-AKI) in patients with heart failure (HF) undergoing iodinated contrast medium (ICM) invasive procedures. (2) Methods: The population was stratified into SGLT2-i users and SGLT2-i non-users according to the chronic treatment with gliflozins. The primary endpoint was CI-AKI incidence during hospitalization. Secondary endpoints were all-cause mortality and the need for continuous renal replacement therapy (CRRT). (3) Results: In total, 86 patients on SGLT2-i and 179 patients not on SGLT2-i were enrolled. The incidence of CI-AKI in the gliflozin group was lower than in the non-user group (9.3 vs. 27.3%, p < 0.001), and these results were confirmed after propensity matching analysis. Multivariable logistic regression showed that only SGLT2-i treatment was an independent preventive factor for CI-AKI (OR: 0.41, 95% CI: 0.16-0.90, p = 0.045). The need for CRRT was reported only in five patients in the non-SGLT2-i-user group compared to zero patients in the gliflozin group (p = 0.05). (4) Conclusions: SGLT2-i therapy was associated with a lower risk of CI-AKI in patients with HF undergoing ICM invasive procedures.

The Value of a Coronary Computed Tomography Angiography plus Stress Cardiac Magnetic Resonance Imaging Strategy for the Evaluation of Patients with Chronic Coronary Syndrome.

Background: Noninvasive imaging methods, either anatomical or functional tests, serve as essential instruments for the appropriate management of patients with established or suspected coronary artery disease (CAD). We sought to evaluate the safety and efficacy of a coronary computed tomography angiography (CCTA) plus stress cardiac magnetic resonance imaging (S-CMR) strategy in patients with chronic coronary syndrome (CCS). Methods: Patients with suspected CCS showing intermediate coronary plaques (stenosis 30-70%) at CCTA underwent S-CMR. Patients with a positive S-CMR were referred to invasive coronary angiography (ICA) plus instantaneous wave-free ratio (iFR), and myocardial revascularization if recommended. All patients received guideline-directed medical therapy (GDMT), including high-dose statins, regardless of myocardial revascularization. The primary endpoint was a composite of death from cardiovascular causes, non-fatal myocardial infarction, and unplanned revascularization. Results: According to the results of CCTA, 62 patients showing intermediate coronary plaques underwent S-CMR, which was positive for a myocardial perfusion deficit in n = 17 (27%) and negative in n = 45 (73%) patients. According to the results of ICA plus iFR, revascularization was performed in 13 patients. No differences in the primary endpoint between the positive and negative S-CMR groups were observed at 1 year (1 [5.9%] vs. 1 [2.2%], p = 0.485) and after a median of 33.4 months (2 [11.8%] vs. 3 [6.7%]; p = 0.605). Conclusions: Our study suggests that a CCTA plus S-CMR strategy is effective for the evaluation of patients with suspicion of CCS at low-intermediate risk, and it may help to refine the selection of patients with intermediate coronary plaques at CCTA needing coronary revascularization.

The Role of Double Interatrial Septum in Cryptogenic Stroke.

In this work, the case of a 70-year-old Caucasian woman affected by cryptogenic stroke is reported. After discarding other sources of embolism, a transesophageal echocardiogram was performed, which revealed the presence of a double interatrial septum associated with a left-sided atrial pouch. The persistent interatrial space was identified as the most probable source of thrombus.

Annual operator volume and procedural outcomes of chronic total occlusions treated with percutaneous coronary interventions: analysis based on 14,899 patients.

BACKGROUND: Low operator and institutional volume is associated with poorer procedural and long-term clinical outcomes in patients treated with percutaneous coronary interventions (PCI). This study was aimed at evaluating the relationship between operator volume and procedural outcomes of patients treated with PCI for chronic total occlusion (CTO). METHODS: Data were obtained from the national registry of percutaneous coronary interventions (ORPKI) collected from January 2014 to December 2020. The primary endpoint was a procedural success, defined as restoration of thrombolysis in myocardial infarction (TIMI) II/III flow without in-hospital cardiac death and myocardial infarction, whereas secondary endpoints included periprocedural complications. RESULTS: Data of 14,899 CTO-PCIs were analyzed. The global procedural success was 66.1%. There was a direct relationship between the annual volume of CTO-PCIs per operator and the procedural success (OR: 1.006 [95% CI: 1.003-1.009]; P<0.001). The nonlinear relationships of annualized CTO-PCI volume per operator and adjusted outcome rates revealed that operators performing 40 CTO cases per year had the best procedural outcomes in terms of technical success (TIMI flow II/III after PCI), coronary artery perforation rate and any periprocedural complications rate (P<0.0001). Among the other factors associated with procedural success, the following can be noted: multi-vessel, left main coronary artery disease (as compared to single-vessel disease), the usage of rotablation as well as PCI within bifurcation. CONCLUSIONS: High-volume CTO operators achieve greater procedural success with a lower frequency of periprocedural complications. Higher annual caseload might increase the overall quality of CTO-PCI.

A streamlined pathway for transcatheter aortic valve implantation: the BENCHMARK study.

BACKGROUND AND AIMS: There is significant potential to streamline the clinical pathway for patients undergoing transcatheter aortic valve implantation (TAVI). The purpose of this study was to evaluate the effect of implementing BENCHMARK best practices on the efficiency and safety of TAVI in 28 sites in 7 European countries. METHODS: This was a study of patients with severe symptomatic aortic stenosis (AS) undergoing TAVI with balloon-expandable valves before and after implementation of BENCHMARK best practices. Principal objectives were to reduce hospital length of stay (LoS) and duration of intensive care stay. Secondary objective was to document patient safety. RESULTS: Between January 2020 and March 2023, 897 patients were documented prior to and 1491 patients after the implementation of BENCHMARK practices. Patient characteristics were consistent with a known older TAVI population and only minor differences. Mean LoS was reduced from 7.7 ± 7.0 to 5.8 ± 5.6 days (median 6 vs. 4 days; P < .001). Duration of intensive care was reduced from 1.8 to 1.3 days (median 1.1 vs. 0.9 days; P < .001). Adoption of peri-procedure best practices led to increased use of local anaesthesia (96.1% vs. 84.3%; P < .001) and decreased procedure (median 47 vs. 60 min; P < .001) and intervention times (85 vs. 95 min; P < .001). Thirty-day patient safety did not appear to be compromised with no differences in all-cause mortality (0.6% in both groups combined), stroke/transient ischaemic attack (1.4%), life-threatening bleeding (1.3%), stage 2/3 acute kidney injury (0.7%), and valve-related readmission (1.2%). CONCLUSIONS: Broad implementation of BENCHMARK practices contributes to improving efficiency of TAVI pathway reducing LoS and costs without compromising patient safety.

Update on chronic total occlusion percutaneous coronary intervention.

Chronic total occlusion (CTO) percutaneous coronary intervention (PCI) continues to evolve. This review summarizes recent publications categorized by outcomes, techniques, complications, and ongoing studies in this rapidly growing area.

Contemporary outcomes of chronic total occlusion percutaneous coronary intervention in Europe: the ERCTO registry.

BACKGROUND: Percutaneous coronary interventions (PCI) of chronic total occlusions (CTO) have reached high procedural success rates thanks to dedicated equipment, evolving techniques, and worldwide adoption of state-of-the-art crossing algorithms. AIMS: We report the contemporary results of CTO PCIs performed by a large European community of experienced interventionalists. Furthermore, we investigated the impact of different risk factors for procedural major adverse cardiac and cerebrovascular events (MACCE) and trends of employment of specific devices like dual lumen microcatheters, guiding catheter extensions, intravascular ultrasound and calcium-modifying tools. METHODS: We evaluated data from 8,673 CTO PCIs included in the European Registry of Chronic Total Occlusion (ERCTO) between January 2021 and October 2022. RESULTS: The overall technical success rate was 89.1% and was higher in antegrade as compared with retrograde cases (92.8% vs 79.3%; p<0.001). Compared with antegrade procedures, retrograde procedures had a higher complexity of attempted lesions (Japanese CTO [J-CTO] score: 3.0±1.0 vs 1.9±1.2; p<0.001), a higher procedural and in-hospital MACCE rate (3.1% vs 1.2%; p<0.018) and a higher perforation rate with and without tamponade (1.5% vs 0.4% and 8.3% vs 2.1%, respectively; p<0.001). As compared with mid-volume operators, high-volume operators had a higher technical success rate in antegrade and retrograde procedures (93.4% vs 91.2% and 81.5% vs 69.0%, respectively; p<0.001), and had a lower MACCE rate (1.47% vs 2.41%; p<0.001) despite a higher mean complexity of the attempted lesions (J-CTO score: 2.42±1.28 vs 2.15±1.27; p<0.001). CONCLUSIONS: The adoption of different recanalisation techniques, operator experience and the use of specific devices have contributed to a high procedural success rate despite the high complexity of the lesions documented in the ERCTO.

Evaluation and management of patients with coronary chronic total occlusions considered for revascularisation. A clinical consensus statement of the European Association of Percutaneous Cardiovascular Interventions (EAPCI) of the ESC, the European Association of Cardiovascular Imaging (EACVI) of the ESC, and the ESC Working Group on Cardiovascular Surgery.

Chronic total occlusions (CTOs) of coronary arteries can be found in the context of chronic or acute coronary syndromes; sometimes they are an incidental finding in those apparently healthy individuals undergoing imaging for preoperative risk assessment. Recently, the invasive management of CTOs has made impressive progress due to sophisticated preinterventional assessment, including advanced non-invasive imaging, the availability of novel and dedicated tools for CTO percutaneous coronary intervention (PCI), and experienced interventionalists working in specialised centres. Thus, it is crucial that referring physicians who see patients with CTO be aware of recent developments and of the initial evaluation requirements for such patients. Besides a careful history and clinical examination, electrocardiograms, exercise tests, and non-invasive imaging modalities are important for selecting the patients most suitable for CTO PCI, while others may be referred to coronary artery bypass graft or optimal medical therapy only. While CTO PCI improves angina and reduces the use of antianginal drugs in patients with symptoms and proven ischaemia, hibernation and/or wall motion abnormalities at baseline or during stress, the effect of CTO PCI on major cardiovascular events is still controversial. This clinical consensus statement specifically focuses on referring physicians, providing a comprehensive algorithm for the preinterventional evaluation of patients with CTO and the current evidence for the clinical effectiveness of the procedure. The proposed care track has been developed by members and with the support of the European Association of Percutaneous Cardiovascular Interventions (EAPCI), the European Association of Cardiovascular Imaging (EACVI), and the European Society of Cardiology (ESC) Working Group on Cardiovascular Surgery.

Patient-specific computer simulation of transcatheter aortic valve replacement in patients with previous mechanical mitral prosthesis: A case series.

Transcatheter aortic valve replacement performed in patients with previously implanted mechanical mitral prosthesis represents a high risk procedure with several potential complications. We report a systematic use of a prediction model based on artificial intelligence to plan the interventional strategy in this challenging scenario.

Use of a steerable delivery sheath to obtain coaxial alignment in left atrial appendage occlusion after mitral transcatheter edge-to-edge repair: a case report.

Background: Patients with atrial fibrillation (AF) have a five-fold increase in stroke events, and ∼90% of the thrombi develop in the left atrial appendage (LAA). Left atrial appendage occlusion (LAAO) has emerged as a safe and feasible alternative to oral anticoagulation (OAC) for stroke prevention in selected patients with non-valvular AF and contraindications to OAC. Atrial fibrillation is closely associated with mitral disease, and there is a growing interest in combined procedures. More than half of patients undergoing a mitral transcatheter edge-to-edge repair (M-TEER) suffer of AF and many have high or unacceptable bleeding risk. Case summary: We present a case of an 80-year-old woman suffering from paroxysmal AF, right carotid siphon aneurysm, and primary mitral regurgitation, with a high bleeding risk, who underwent a combined intervention of M-TEER and LAAO. Discussion: The combination of these two procedures is a logical step once the access to the left atrium is obtained with a transseptal puncture (TSP) and a transesophageal echocardiography (TEE) is in place to guide both procedures. The turning point in LAAO procedure is a correct TSP allowing coaxial alignment of the sheath with the LAA neck. Steerable delivery sheaths are promising dedicated tools, particularly in challenging anatomy or during combined procedures requiring different TSP positions.

Serial Changes in Cardiopulmonary Exercise Testing Parameters in Untreated Patients With Transthyretin Cardiac Amyloidosis.

BACKGROUND: Transthyretin amyloid cardiomyopathy (ATTR-CM) is associated with a progressive reduction of functional capacity. The progression of cardiopulmonary exercise testing (CPET) parameters over time is still unknown. METHODS: In this study, 55 patients with ATTR-CM underwent 2 serial cardiologic evaluations and CPETs in a national referral center for cardiac amyloidosis (Careggi University Hospital, Florence). RESULTS: Forty-three patients (78%) had wild-type ATTR. Median age was 80 years (interquartile range [IQR] 76-83 years), and 50 of the patients (91%) were men. At baseline, median peak oxygen consumption (pVO2) was 15 mL/kg/min (IQR 12-18 mL/kg/min), percentage of predicted pVO2 (%ppVO2) was 71% (IQR 60%-83%) and VE/VCO2 slope was 31 (IQR 26-34). After a median follow-up of 14 months (IQR 13-16 months), pVO2, %ppVO2 and VE/VCO2 slope were significantly worsened (-1.29 mL/kg/min [95% confidence interval (CI): -1.85 to -0.74; P < 0.01], -4.5% [95% CI: -6.9 to -2.02; P < 0.01], and 8.6 [95% CI 6-11; P < 0.01], respectively). Furthermore, exercise time (-39 s, 95% CI: -59 to -19; P < 0.01), exercise tolerance (-0.47 metabolic equivalents, 95% CI: -0.69 to -0.2; P < 0.01), and peak systolic pressure (-10.8 mm Hg, 95% CI: -16.2 to -5.4; P < 0.01) were significantly reduced. The worsening in CPET variables did not correspond with a significant change in echocardiographic parameters. CONCLUSIONS: Cardiorespiratory response to exercise significantly worsened over a short period of time in patients with ATTR-CM. Serial CPET may be useful to identify early disease progression.

Quality control in treating patients with patent foramen ovale: 7-year-experience of the Heart and Brain team of the Careggi University Hospital.

BACKGROUND: The right comprehension of ischemic stroke pathogenesis guarantees the best prevention therapy. The term "patent foramen ovale (PFO) related stroke" has been proposed for those events where PFO is supposed to be pathogenetic, but their definition is challenging. A multidisciplinary evaluation in a "Heart & Brain" team (HBteam) including stroke neurologists and interventional cardiologists was therefore highly recommended in the recent guidelines of secondary stroke prevention. OBJECTIVE: We aimed at describing the organization of the HBteam of Careggi-University-Hospital of Florence (Italy), and the results of the first seven years of activity. METHODS: In 2016 Interventional Cardiologists and Stroke Neurologists set up an outpatient clinic for the joined evaluation of patients with PFO and other cardio/neurological conditions. A specific diagnostic-therapeutic hospital plan was produced for PFO patients. Patient empowerment was guaranteed by a hospital explicative webpage, a booklet regarding risks/benefits of PFO closure and a 3D heartmodel to simulate the intervention. Data were collected in a dedicated registry. RESULTS: We evaluated 594 patients for PFO, 40 for left atrial appendage closure and 38 for other conditions. In 20% of PFO-patients, HBteam diagnosis was discordant from that of referring physicians, 14% were stroke misdiagnoses. We advised against closure in 53% of patients. At follow-up 94% of closed patients had no/minimum residual shunt; 3 patients had a cerebral ischemic event. CONCLUSIONS: A dedicated HBteam represents a unique opportunity to share decisions with patients after a thorough empowerment process. The joining of cardioneurological skills allows a better classification of PFO-patients, reducing futile interventions.

Inflammation in acute heart failure.

Acute heart failure (AHF) represents a common clinical scenario that requires prompt evaluation and therapy and that is characterized by a high risk of mortality or subsequent rehospitalizations. The pathophysiology leading to AHF decompensation is still not fully understood. Significant activation of inflammatory pathways has been identified in patients with AHF, particularly in its most severe forms, and it has been hypothesized that systemic inflammation has a role in AHF pathogenesis. Several inflammatory mediators and cytokines, such as high sensitivity C-reactive protein, tumor necrosis factor-α, interleukin-6, interleukin-1, soluble suppression of tumorigenicity 2 and galectin-3, have been shown to play a role in the pathogenesis, development and worsening of this condition with an independent prediction of adverse outcomes. This manuscript reviews the prevalence and prognostic value of systemic inflammation in AHF, as well as the potential role of anti-inflammatory therapies, focusing on available evidence from clinical trials and ongoing studies.

Comparison of the Clinical and Metabolic Characteristics of Patients With Acute Coronary Syndromes Between the Pre- and Post-lockdown Periods.

INTRODUCTION: In 2020, the SARS-CoV-2 pandemic outbreak required restrictive measures to limit the spread of the virus. This study aimed to assess how changes in dietary habits and lifestyle associated with such measures have affected the characteristics of patients with acute coronary syndromes (ACS) in the post-lockdown period. In particular, we evaluated if the incidence of ACS was higher in younger patients, who were more negatively affected by lockdown measures. METHODS: We analysed 609 ACS patients and compared the clinical, laboratory, and angiographic characteristics of those admitted six months before lockdown (n = 312) and those admitted in the same six-month period after lockdown. Moreover, we compared several anthropometric and laboratory data between pre- and post-lockdown in younger (≤55 years old) and older patients. RESULTS: The incidence of ACS in young adults (≤55 years) was significantly higher in the post- vs. pre-lockdown period (17.5% vs. 10.9%, p = 0.019). A trend to a higher percentage of ST-elevation myocardial infarction (STEMI) was observed in the post-lockdown period together with a significantly lower incidence of non-STEMI (p = 0.033). Moreover, in the post-lockdown period, we observed in younger patients a significant increase in weight, body mass index, admission glycaemia, and triglycerides while in older patients, these parameters were significantly reduced. CONCLUSION: The lockdown may have negatively affected cardiovascular risk, thus increasing the incidence of ACS, particularly in younger patients who probably underwent more relevant lifestyle changes, with several consequent anthropometric and metabolic alterations. Such evidence should be considered to take preventive measures in case a new state of emergency occurs.