Risultati per: Cardio-oncology: rivista open access

Objective
This qualitative study aimed to analyse rectal cancer survivors’ lived experiences to identify facilitators and barriers to support access.

Design
We conducted one-on-one semi-structured interviews and employed thematic analysis to identify key themes and insights.

Setting/participants
Participants included eight rectal cancer survivors and three caregivers recruited at Texas Colorectal Collaborative sites.

Results
Results showed that adequate hospital resources, high health literacy and close connections with clinicians and peers who share similar experiences facilitate survivors’ access to social support. Conversely, ineffective healthcare team communication, financial challenges and low self-motivation hindered access.

Conclusion
Survivorship experiences were shaped by varying degrees of social support access, influenced by internal and external factors. We aim to establish a cross-institutional survivorship support network to address these factors, ensuring equitable access to support services and enhancing survivorship experiences.

Circulation, Ahead of Print. Background: In the phase 3 randomized controlled study, ATTRibute-CM, acoramidis, a transthyretin (TTR) stabilizer, demonstrated significant efficacy on the primary endpoint. Participants with transthyretin amyloid cardiomyopathy (ATTR-CM) who completed ATTRibute-CM were invited to enroll in an open-label extension study (OLE). We report efficacy and safety data of acoramidis in participants who completed ATTRibute-CM and enrolled in the ongoing OLE.Methods: Participants who previously received acoramidis through Month 30 (M30) in ATTRibute-CM continued to receive it (continuous acoramidis), and those who received placebo through M30 were switched to acoramidis (placebo to acoramidis). Participants who received concomitant tafamidis in ATTRibute-CM were required to discontinue it to be eligible to enroll in the OLE. Clinical efficacy outcomes analyzed through Month 42 (M42) included time to event for all-cause mortality (ACM) or first cardiovascular-related hospitalization (CVH), ACM alone, first CVH alone, ACM or recurrent CVH, change from baseline in N-terminal pro-B-type natriuretic peptide (NT-proBNP), 6-minute walk distance (6MWD), serum TTR, and the Kansas City Cardiomyopathy Questionnaire Overall Summary score (KCCQ-OS). Safety outcomes were analyzed through M42.Results: Overall, 438 of 632 participants in ATTRibute-CM completed treatment and 389 enrolled in the ongoing OLE (263 continuous acoramidis, 126 placebo to acoramidis). The hazard ratio (HR) (95% CI) for ACM or first CVH was 0.57 (0.46, 0.72) at M42 based on a stratified Cox proportional hazards model (P-value < 0.0001) favoring continuous acoramidis. Similar analyses were performed on ACM alone and first CVH alone, with HRs (95% CI) of 0.64 (0.47, 0.88) and 0.53 (0.41, 0.69), respectively, at M42. Treatment effects for NT-proBNP and 6MWD also favored continuous acoramidis. Upon initiation of open-label acoramidis in the placebo-to-acoramidis arm there was a prompt increase in serum TTR. Quality of life assessed by KCCQ-OS was well preserved in continuous acoramidis participants compared with the placebo to acoramidis participants. No new clinically important safety issues were identified in this long-term evaluation.Conclusions: Early initiation and continuous use of acoramidis in the ATTRibute-CM study through M42 of the ongoing OLE study was associated with sustained clinical benefits in a contemporary ATTR-CM cohort, with no clinically important safety issues newly identified.

Circulation, Ahead of Print. Background: The optimal duration of anticoagulation therapy for patients with cancer and acute low-risk pulmonary embolism (PE) is clinically relevant, but evidence is lacking. Prolonged anticoagulation therapy could have a potential benefit for prevention of thrombotic events; however, it could also increase the risk of bleeding.Methods: In a multicenter, open-label, adjudicator-blinded, randomized clinical trial at 32 institutions in Japan, we randomly assigned patients with cancer and acute low-risk PE of the simplified version of the Pulmonary Embolism Severity Index score of 1, in a 1:1 ratio, to receive either an 18-month or a 6-month rivaroxaban treatment. The primary end point was recurrent venous thromboembolism (VTE) at 18 months. The major secondary end point was major bleeding at 18 months according to the criteria of the International Society on Thrombosis and Hemostasis. The primary hypothesis was that an 18-month treatment was superior to a 6-month treatment in terms of the primary end point.Results: From February 2021 to March 2023, 179 patients were randomized, and after the exclusion of one patient who withdrew consent, 178 were included in the intention-to-treat population: 89 patients in the 18-month rivaroxaban group and 89 in the 6-month rivaroxaban group. The mean age was 65.7 years; 47% of the patients were men, and 12% had symptoms of PE at baseline. The primary end point of recurrent VTE occurred in 5 of the 89 patients (5.6%) in the 18-month rivaroxaban group and in 17 of the 89 (19.1%) in the 6-month rivaroxaban group (odds ratio, 0.25 [95% CI, 0.09–0.72];P=0.01). Among 22 recurrent VTE, 5 patients presented with a symptomatic recurrent VTE; recurrent PE occurred in 11 patients, including 2 with main and 4 with lobar PEs; and recurrent deep vein thrombosis was seen in 11 patients, including 3 with proximal deep vein thromboses. The major secondary end point of major bleeding occurred in 7 of the 89 patients (7.8 %) in the 18-month rivaroxaban group and in 5 of the 89 patients (5.6%) in the 6-month rivaroxaban group (odds ratio, 1.43 [95% CI, 0.44–4.70];P=0.55).Conclusions: In patients with cancer and acute low-risk PE of the simplified version of the Pulmonary Embolism Severity Index score of 1, the 18-month rivaroxaban treatment was superior to the 6-month rivaroxaban treatment with respect to recurrent VTE events.

Introduction
Janus kinase (JAK) inhibitors are an important therapeutic option in the treatment of rheumatoid arthritis, but increase the risk of developing herpes zoster. Although a dry recombinant zoster vaccine (RZV) that can be used under immunosuppressive conditions has recently been developed, its optimal use and appropriate timing in patients scheduled to start JAK inhibitors is still unclear. The present study is designed to clarify the appropriate timing of JAK inhibitor initiation to measure varicella zoster virus (VZV)-specific IgG titers and VZV-specific T cell response in patients with rheumatoid arthritis who start tofacitinib at the first RZV vaccination or at the second one.

Methods and analysis
STOP HZ (Effectiveness and S afe T y O f P rophylactic Recombinant H erpes Z oster Virus Vaccination for Rheumatoid Arthritis Patients with Tofacitinib Treatment) study is a multicentre, open-label, randomised, comparative study in patients with rheumatoid arthritis who are scheduled to start tofacitinib. This study enrols 60 study subjects in 12 sites. Enrolled subjects receive RZV two times on day 1 and week 8 and initiate tofacitinib 5 mg two times a day at the time of their first RZV (day 1, group A) or second RZV (week 8, group B) based on randomisation. The random assignment is performed centrally in a 1:1 ratio. Patients in Group B continue the same treatment until the start of tofacitinib treatment. Primary endpoint is VZV-specific IgG antibody titers at week 12 compared with those at baseline in each group. Secondary endpoints include comparison of VZV-specific IgG antibody between the groups, changes in disease activity of rheumatoid arthritis, VZV-specific T cell response and adverse events.

Ethics and dissemination
The study has been approved by the Certified Review Board of Keio (No. 2022008), and conforms to the Declaration of Helsinki and good clinical practice guidelines. Written informed consent is obtained from participants prior to enrolment. The results of this study are planned to be submitted for publishment in relevant peer-review journals.

Trial registration number
jRCTs031230329.

Long-lasting consciousness improvements were observed in patients treated with apomorphine, compared to controls and compared to baseline. Changes in brain connectivity and metabolism were observed after treatment, providing insights into possible neurophysiological mechanisms and target areas. This open-label study confirmed the feasibility and safety of apomorphine treatment, which may represent a key therapeutic option for PDoC.

The purpose of this American Gastroenterological Association (AGA) Clinical Practice Update is to facilitate understanding and improve the clinical practice of endoscopic enteral access.

Introduction
In critically ill patients, individualised strategies for red blood cell transfusion (RBCT) are lacking. The objective of this study is to demonstrate the potential advantages of employing an individualised transfusion strategy compared with a restrictive approach, in unselected intensive care unit (ICU) patients.

Methods
This will be a randomised, multicentre, international trial. Two open-label parallel groups will be compared with an allocation ratio of 1:1. The trial is designed to investigate the superiority of the individualised intervention group compared with the standard intervention group. The study will be performed in three mixed, academic ICUs located in two different countries. In the individualised group, prescription of RCBT is restricted to patients who present haemoglobin (Hb) ≤9.0 g/dL and oxygen extraction ratio (O2ER) ≥ 30%, for a minimum Hb value of ≤6.0 g/dL. In the control group, prescription of RBCT is guided by thresholds proposed by recent guidelines, regardless of O2ER values.

Ethics and dissemination
This trial is approved by the Comitato Etico Area Vasta Centro della Regione Emilia-Romagna (protocol number 350/2023/Sper/AOUFe/PRBCT, date of approval 18/05/2023) and ethic boards at all participating sites. Our results will be published and shared with relevant organisations and healthcare professionals.

Trial registration number
Clinicaltrials.gov NCT06102590

Purpose
The FUPEC (Follow-Up Pre-EClampsia) study aims to investigate the presence and development of cardiovascular risk factors, cardiovascular disease, as well as cardiovascular health following a pregnancy complicated by severe pre-eclampsia.

Participants
The FUPEC study is an open-cohort study conducted within routine care at the FUPEC clinic at Erasmus Medical Center in the Netherlands. This clinic is specifically designed for the cardiovascular follow-up of patients who have experienced severe pre-eclampsia. Women with a history of severe pre-eclampsia are invited to the FUPEC clinic at 6 weeks, 3 months, 1 year and every 2 years thereafter postpartum until they are 50 years of age. Clinical and biochemical data are routinely collected, encompassing pregnancy characteristics and outcomes, anthropometric measurements, cardiovascular risk factors, cardiovascular health scores, carotid intima-media thickness—including vascular age and ambulatory blood pressure measurements. Additionally, blood and urine samples are collected and stored in a biobank.

Findings to date
The first patient was enrolled in April 2011. As of March 2024, a total number of 1268 women have been enrolled in the FUPEC study, with an annual enrolment rate of 100–150 new patients. At inclusion, women had a median age of 33.5 years (IQR 30.1–37.9). At their first FUPEC visit, women were a median of 4.9 months (1.9–29.4) after delivery. At the first visit, the median body mass index was 25.7 (IQR 23.0–29.9) kg/m2, 23.4% of participants were using antihypertensive medication and 6.4% were smoking. Preliminary analyses of 24-hour blood pressure patterns and carotid intima-media thickness have previously been conducted on a subset of the cohort, with details provided in the ‘Findings to Date’ section.

Future plans
The FUPEC cohort serves as a robust clinical data source and biobank that can be used for future studies and collaborative research answering, for example, questions on the aetiology, risk factors and short-term and long-term complications of pregnancies complicated by severe pre-eclampsia. Since the FUPEC cohort is integrated with routine care, there is no strict completion of data collection, allowing for flexible data acquisition.

Circulation, Volume 150, Issue Suppl_1, Page A4144560-A4144560, November 12, 2024. Introduction:Protein-losing enteropathy (PLE) is a multifaceted condition that profoundly affects the systemic health and quality of life of Fontan patients. Despite medical progress, the treatment of PLE remains a significant challenge. This study investigates the efficacy and safety of Camostat Mesylate for managing PLE patients who have undergone the Fontan operation.Hypothesis:We hypothesize that Camostat Mesylate will enhance the gut environment, resulting in increase of serum albumin levels and decrease of stool alpha-1 antitrypsin levels in PLE patients following Fontan operation.Methods:This phase 2, multicenter, open-label, single-arm trial included patients over 4 years old diagnosed with PLE following Fontan operation. Camostat Mesylate was added to conventional treatments, with follow-up assessments at 1, 3, and 6 months, and a final evaluation one month after discontinuation. Efficacy was measured by changes in serum albumin, stool alpha-1 antitrypsin levels, and PLE symptoms such as diarrhea, edema, weight changes, and ascites.Results:Nineteen patients were enrolled in the study, of whom fifteen patients completed follow-up as per protocol. The median age was 15 years (interquartile range, 12.0-21.3). The median time between the Fontan operation and PLE diagnosis was 2.4 years. Serum albumin levels increased from 2.5 to 2.6 g/dL (p=0.504), and stool alpha-1 antitrypsin levels decreased significantly from 280.0 to 172.1 mg/dL (p=0.033). Notably, patients with diarrhea at baseline showed substantial improvement in both parameters, with increased serum albumin levels from 1.8 to 2.2 g/dL and decreased stool alpha-1 antitrypsin levels from 220.3 to 80.2 mg/dL. No serious adverse events were reported during study period.Conclusions:Camostat Mesylate demonstrated safety and efficacy, reducing stool alpha-1 antitrypsin in PLE patients after Fontan operation, especially those with diarrhea at baseline. Therefore, Camostat Mesylate could be considered as an additional treatment option for patients with PLE following Fontan operation.Key words:Camostat mesylate; protein-losing enteropathy; Fontan operationSource of Funding:This research was funded by SNUH Lee Kun-hee Child Cancer&Rare Disease Project, Republic of Korea.

Circulation, Volume 150, Issue Suppl_1, Page A4144542-A4144542, November 12, 2024. Background:Radiation associated heart disease has a wide spectrum of manifestations including pericardial disease, coronary artery disease, and valvular heart disease. Mitral valve regurgitation is the second most common valvular dysfunction in patients with prior mediastinal radiation.Research Question:What are the outcomes of percutaneous or transcatheter mitral valve replacement/repair (T-MVR) versus surgical mitral valve replacement/repair (S-MVR) in patients with prior mediastinal radiation.Methods:The National Inpatient Sample (NIS) was analyzed from 2015-2020 to identify patients with mediastinal tumors and prior exposure to radiation therapy undergoing mitral valve repair/replacement. We subclassified the data into hospitalizations for S-MVR and T-MVR. Baseline characteristics were compared between the two groups and multivariate logistic regression was used to analyze hospitalization outcomes.Results:A total of 1725 patients with prior mediastinal radiation were hospitalized for MVR; 1110 (64.3%) patients underwent S-MVR and 615 (35.6%) patients underwent T-MVR. On a multivariable analysis, the odds of MACCE [aOR: 2.21; 95 % CI: (1.87-4.01); p

Circulation, Volume 150, Issue Suppl_1, Page A4140139-A4140139, November 12, 2024. Introduction:The cardio-ankle vascular index (CAVI) is a significant metric for evaluating arterial function. The test measures the stiffness of the arteries from the beginning of the aorta to the ankle, and the algorithm used is not influenced by blood pressure. Recent statistics indicate that a high CAVI score has the potential to predict future cardiovascular disease (CVD) occurrences. However, no research has been conducted in Vietnam to investigate this matter.Methods:A prospective study was conducted on 222 patients. Out of these, 162 patients had chronic coronary artery disease (CAD), while the remaining 62 patients were free of CAD. The study took place between October 2019 and December 2022. Participants who fulfilled the criteria were evaluated using the CAVI baseline measurement and clinical and paraclinical parameters. A total of 162 patients with chronic coronary artery disease (CAD) were monitored for cardiovascular disease (CVD) events over a period of 2 years.Results:CAVI in chronic CAD patients (9.21±0.79) was significantly higher compared to those in free-CAD patients (8.48 ± 0.62) with p

Circulation, Volume 150, Issue Suppl_1, Page A4141761-A4141761, November 12, 2024. Background:Rotational atherectomy has been performed using both radial and femoral access over the years, but there is a lack of consensus on the safety and efficacy of these access sites.Aim:To assess the safety and efficacy of radial access and femoral access.Methods:MEDLINE, Scopus, and Cochrane Library were searched until May 2024 for studies comparing radial approach with femoral approach in patients undergoing rotational atherectomy. The primary outcome was major vascular site bleeding. Secondary outcomes included short-term mortality, long-term mortality, myocardial infarction, major adverse cardiovascular events (MACE), acute stent thrombosis, procedural success, procedural time, hospital stay and radiation exposure. Effect estimates were synthesized using a random-effects model and expressed as risk ratios (RR) for dichotomous outcomes and mean difference (MD) for continuous outcomes, with corresponding 95% confidence intervals (CIs).Results:13 studies including 13,581 patients with mean age of 60.76 years in the radial group and 66.86 years in the femoral group, who had undergone rotational atherectomy, were included in the analysis. For the outcome of major vascular site bleeding, there was significantly lower risk (RR: 0.25; 95% CI [0.15, 0.43]; p

Circulation, Volume 150, Issue Suppl_1, Page A4113573-A4113573, November 12, 2024. Introduction/Background:Cardiovascular and neurological diseases develop in a significant proportion of COVID-19 patients. Minimally invasive tools to predict outcome after SARS-CoV-2 infection would enable personalized healthcare, potentially easing the disease burden. We showed that blood levels of the long noncoding RNA lymphoid enhancer-binding factor-1 antisense 1 (LEF1-AS1) predict COVID-19 in-hospital mortality.Hypothesis:LEF1-AS1 is associated with long-term clinical outcomes of COVID-19.Aim:Test the capacity of LEF1-AS1 to predict neuro-cardio-vascular outcomes post-SARS-CoV-2 infection.Methods/Approach:We enrolled 104 primo-infected COVID-19 patients aged 18+ recruited from April to December 2020 in the PrediCOVID national cohort for which 12-month follow-up data were available (Ethics Committee approvals 202003/07 and 202310/02-SU-202003/07). Whole blood samples were collected at baseline and expression levels of LEF1-AS1 were assessed by quantitative PCR.Results/Data:Of the 104 patients, 35 had at least one neurological symptom and one cardiovascular symptom at month 12. Levels of LEF1-AS1 at baseline were lower (p=0.019) in patients who developed neurological and cardiovascular symptoms as compared to patients who did not. Lower LEF1-AS1 was associated with symptoms development with an odds ratio of 0.48 (95% CI 0.28-0.83) from logistic regression model adjusted for age, sex, comorbidities and disease severity at baseline. Addition of LEF1-AS1 to a clinical model including age, sex, comorbidities and baseline severity yielded an incremental predictive value as attested by an increased AUC from 0.79 to 0.83 (likelihood ratio test p=0.005), a net reclassification index of 0.54 (p=0.007) and an integrated discrimination improvement of 0.08 (p=0.009).Conclusion:Blood levels of LEF1-AS1 predict 12-month neurological and cardiovascular outcomes of COVID-19 patients. This needs to be validated in larger populations.

Circulation, Volume 150, Issue Suppl_1, Page A4142895-A4142895, November 12, 2024. Background:We explored the potential of cutting-edge open-label artificial intelligence, particularly the unique cognitive capabilities it offers, in modern clinical practice. Our study evaluated the efficacy of online open-source generative pre-trained transformers (ChatGPT) in predicting cardiovascular risk in patients with heart failure and preserved ejection fraction, comparing its performance with expert-based clinical stratification.Methods:Retrospectively, we included 772 patients presenting with heart failure symptoms (mean age: 69±6 years, 56% female, mean ejection fraction: 61±5%, all >50%). They were followed for a median of 3.9 years for occurrences of death and hospitalization due to heart failure (HF). A script incorporating 12 variables (see Figure 1) was generated and submitted to the ChatGPT website, utilizing the returned score. Additionally, the H2FPEF score was computed as per guidelines. We then compared the predictive capabilities of both models for outcomes.Results:During follow-up, 17 patients died, 52 were hospitalized, and 67 experienced the combined outcome. The average ChatGPT score stood at 6.1±1.7, whereas the mean H2FPEF score was 3.1±1.5, exhibiting a modest correlation (r=0.51, p

Circulation, Volume 150, Issue Suppl_1, Page A4141052-A4141052, November 12, 2024. Introduction:Cardio-cerebral infarction, a rare clinical presentation involving simultaneous acute ischemic stroke and acute myocardial infarction, poses significant therapeutic challenges. The incidence of this dual infarction is currently unknown due to its rarity. Delaying intervention for one condition to address the other can lead to permanent morbidity, disability, or even death. Coronary artery fistulas are uncommon with estimated incidence of 0.3%. Among these, a fistula between the left anterior descending artery and the pulmonary artery is the rarest variant, comprising about 17% of all coronary artery fistula cases.Case:A 54-year-old male, with a known history of atrial fibrillation and hypertension, presented to our emergency department with non-rotatory dizziness. Physical examination was unremarkable, but neurological examination revealed medial rectus palsy and left facial asymmetry. A cranial MRI indicated a hyperacute infarction in the left cerebellum. Laboratory tests showed markedly elevated troponin I levels ( >50 ng/ml) and atrial fibrillation, along with inferior wall ST elevation on the electrocardiogram. Due to the high risk of hemorrhagic conversion, the loading of antiplatelets was deferred. Instead, the patient was treated with Aspirin 80 mg once daily, Clopidogrel 75 mg once daily, and Enoxaparin 0.4 ml subcutaneously once daily. A 2D echocardiogram revealed an ejection fraction of 43%, hypokinesia of the anterior and intraventricular septum from base to apex, and severe mitral stenosis. Cardiac catheterization identified a coronary artery fistula from the left anterior descending coronary artery to the main pulmonary artery. Treatment for acute coronary syndrome and acute cerebellar infarct continued. An open-heart surgery was considered. However, during his hospital stay, the patient experienced hemorrhagic conversion and altered sensorium. His condition further deteriorated, necessitating a tracheostomy and long-term care.Conclusion:Cardio-cerebral infarction is an extremely rare and poorly studied syndrome that presents significant treatment challenges and carries a grave prognosis if not addressed immediately. The medical conundrum of deciding which condition to treat first underscores the need for further research. Both interventional cardiologists and interventional neuroradiologists play crucial roles in the effective management of this emergency condition.

Circulation, Volume 150, Issue Suppl_1, Page A4137441-A4137441, November 12, 2024. Background:Cardiac surgery is a significant procedure that reduces mortality and alleviates symptom burden in individuals with cardiovascular diseases. However, many patients develop depression and cardiac-related anxiety postoperatively, which negatively affects long-term prognosis and rehabilitation. There is a clinical need to develop scalable psychological treatments to mitigate these negative health effects.Objective:To investigate the feasibility and potential efficacy of a brief internet-delivered cognitive behavioral therapy (internet-CBT) intervention to reduce psychological distress in patients following cardiac surgery.Methods:The pilot study included 32 cardiac surgery patients (i.e., CABG, heart valve repair/replacement, aortic repair, or combined CABG and valve repair/replacement) with endorsed postoperative psychological distress and/or interference with daily life who underwent surgery from eight weeks to nine months prior to enrollment. Exclusion criteria included prior cardiac surgery with a ventricular assist device or heart transplant and severe medical or psychiatric illness. The internet-CBT targeted cardiac anxiety and depressive inactivity, lasted for five weeks, and was guided by clinical psychologists via text-based interactive online treatment modules. It included interoceptive exposure, in-vivo exposure, and behavioral activation. Self-assessments were completed at pre-treatment, post-treatment, and at 6-month follow-up.Results:Preliminary analyses post-treatment showed substantial pre-post improvements across multiple domains. Notable findings included significant reductions in depressive symptoms (Cohen’s d = 0.70; p = 0.04), cardiac anxiety (Cohen’s d = 1.53; p < 0.001), and perceived severity of post-operative symptoms (Cohen’s d = 1.06; p = 0.006). Participants demonstrated high adherence to the treatment, with the large majority of participants completing all five treatment modules (83.3%). Satisfaction with the treatment was also high (25.5 points out of 32), as measured by the Client Satisfaction Questionnaire, and no adverse events were reported.Conclusion:This novel internet-CBT intervention post-cardiac surgery appears to be feasible, acceptable, and clinically promising in reducing postoperative psychological distress. It could be used as a viable adjunct treatment to enhance recovery post-cardiac surgery. These preliminary findings warrant further testing in a randomized controlled trial.