Risultati per: Cardio-oncology: rivista open access

Introduction
The only curative treatment for most gastric cancer is radical gastrectomy with D2 lymphadenectomy (LAD). Minimally invasive total gastrectomy (MIG) aims to reduce postoperative morbidity, but its use has not yet been widely established in Western countries. Minimally invasivE versus open total GAstrectomy is the first Western multicentre randomised controlled trial (RCT) to compare postoperative morbidity following MIG vs open total gastrectomy (OG).

Methods and analysis
This superiority multicentre RCT compares MIG (intervention) to OG (control) for oncological total gastrectomy with D2 or D2+LAD. Recruitment is expected to last for 2 years. Inclusion criteria comprise age between 18 and 84 years and planned total gastrectomy after initial diagnosis of gastric carcinoma. Exclusion criteria include Eastern Co-operative Oncology Group (ECOG) performance status >2, tumours requiring extended gastrectomy or less than total gastrectomy, previous abdominal surgery or extensive adhesions seriously complicating MIG, other active oncological disease, advanced stages (T4 or M1), emergency setting and pregnancy.
The sample size was calculated at 80 participants per group. The primary endpoint is 30-day postoperative morbidity as measured by the Comprehensive Complications Index. Secondary endpoints include postoperative morbidity and mortality, adherence to a fast-track protocol and patient-reported quality of life (QoL) scores (QoR-15, EUROQOL EuroQol-5 Dimensions-5 Levels (EQ-5D), EORTC QLQ-C30, EORTC QLQ-STO22, activities of daily living and Body Image Scale). Oncological endpoints include rate of R0 resection, lymph node yield, disease-free survival and overall survival at 60-month follow-up.

Ethics and dissemination
Ethical approval has been received by the independent Ethics Committee of the Medical Faculty, University of Heidelberg (S-816/2021) and will be received from each responsible ethics committee for each individual participating centre prior to recruitment. Results will be published open access.

Trial registration number
DRKS00025765.

Circulation, Volume 146, Issue Suppl_1, Page A14711-A14711, November 8, 2022. BackgroundRadial artery occlusion (RAO) with transradial access is reported in 6-9% of patients with advanced chronic kidney disease (CKD) and may preclude the creation of an arteriovenous fistula for dialysis. Distal transradial access (dTRA) has lower rates of RAO compared with proximal transradial access but studies excluded patients with advanced CKD.Methods:We sought to define procedure characteristics and RAO rates with dTRA in CKD. Patients who underwent cardiac catheterization with dTRA from 01/01/2019 to 01/01/2022 with follow-up of radial artery patency by reverse Barbeau or repeat access of the artery were included.Results:A total of 68 patients with a median age of 60 (IQR 54-69), 50 (74%) males were included. A total of 44 (65%) were on hemodialysis. Of the procedures, 59 (87%) were diagnostic and 9 (13%) were PCIs. Access was ultrasound guided, a majority (79%) were right dTRA and all had spasmolytic therapy and patent hemostasis. Sheaths were 5 French short (7 cm) in 40 (59%) and 6 French short in 28 (41%). Mean contrast volume was 20+/-11 ml for diagnostic procedures and 91+/-53 ml for PCIs. Mean radiation exposure was 290+/-156 mGy for diagnostic procedures and 1692+/-961 mGy for PCIs. Mean fluoro time was 5+/-4 mins for diagnostic procedures and 24+/-13 mins for PCIs.Of 9 patients with PCIs, mean number of stents was 2+/-1 and atherectomy was used in 2 (22%) PCIs. The median number of diagnostic catheters was 1(IQR 1-2) and median guides was 1(IQR 1-1) in PCIs. Radial arteries were patent in 68 (100%) at follow-up.(Figure 1)Conclusions:Our cohort demonstrates safety of dTRA in patients with advanced CKD with high rates of radial artery patency.

Circulation, Volume 146, Issue Suppl_1, Page A14706-A14706, November 8, 2022. Background:Disparities in heart failure (HF) outcomes exist in the United States, in part, due to social determinants of health. Individuals from racial and ethnic minority groups report the highest rates of cost-related delays in care and worse access to high-quality medical therapy. We have previously demonstrated that individuals residing in more deprived neighborhoods experience higher readmissions, and Black patients are more likely to reside in deprived neighborhoods than White patients. Here, we engaged patients from the most deprived neighborhoods to understand drivers of excess readmission from the patient perspective.Methods:We conducted semi-structured in-depth interviews with 25 patients (mean age 61 ± 9 years, 96% Black, 40% female) readmitted with HF at Emory Healthcare hospitals, and living in a neighborhood in the top 10% of the Social Deprivation Index. Qualitative descriptive analysis of the interviews was performed using a multilevel coding strategy.Results:Patients in this cohort had a mean EF 39 ± 19%, and experienced 3.2 ± 2.5 readmissions in the preceding 12 months. Most patients (84%) highlighted lack of access to medications as a driver of hospital readmission. Representative quotes from individual patients are highlighted in theTable.Patients reported the etiology of their lack of medication access included medication costs (64%), only having access to re-fills through the emergency room or hospitalization (36%), low health literacy (12%), and limited access to transportation (8%).Conclusion:Lack of access to medications for patients with HF who live in socioeconomically deprived neighborhoods poses a challenge to reducing the burden of HF. Providing cost-effective and sustainable access to medications for patients with HF from low resource settings is a potential solution to decrease the number of HF hospitalization and readmissions in this vulnerable patient population.

Circulation, Volume 146, Issue Suppl_1, Page A14704-A14704, November 8, 2022. Introduction:Percutaneous epicardial access (EpiAcc) is frequently required for endo-epicardial ablation of ventricular tachycardia (VT), especially in ischemic cardiomyopathy, where it has been demonstrated to increase success rate. For patients who have indications for chronic oral anticoagulation (OAC), this often poses a challenge due to potential risks of procedural complications. We sought to assess the safety and outcomes of epicardial VT ablation on uninterrupted OAC compared to off anticoagulation.Methods:In this multicenter study, we retrospectively analyzed patients with ischemic cardiomyopathy and VT who underwent endo-epicardial ablation with EpiAcc. The study group included patients who underwent ablation either under uninterrupted OAC or off anticoagulation. Procedural data, outcomes, and complication rates were analyzed for comparison of both groups.Results:Overall, we analyzed 135 patients who underwent VT ablation via EpiAcc; 55 under full-dose uninterrupted AC and 80 off AC. There was no difference in procedure-related complications between both groups (1.8% vs 2.5%, p=0.09). There was no major bleeding requiring transfusion in any group. There was no difference in risk of cardiac tamponade between both groups (0% vs 0%, p=1). The rate of groin hematoma was 1.8% vs 1.3%, p=0.087). No thromboembolic events were reported.Conclusion:Epicardial VT ablation on uninterrupted OAC is a safe alternative to off AC, with no additional risk of life-threatening complications, thus preventing the possibility of thromboembolic events in patients who have an indication for chronic AC.1

Circulation, Volume 146, Issue Suppl_1, Page A10019-A10019, November 8, 2022. Background:Sodium glucose cotransporter-2 inhibitors (SGLT-2i) and glucagon-like peptide-1 receptor agonists (GLP-1RA) are the only cardioprotective anti-hyperglycemic medications, but have had limited use. We evaluated whether access to specialty cardiovascular care improves the uptake of these cardioprotective medications in type 2 diabetes (T2D).Methods:In a retrospective cohort study between Jan 2019 and Dec 2020, beneficiaries with Medicare Advantage or commercial insurance were followed using Optum Labs’ de-identified administrative claims for the initiation of SGLT-2i and GLP-1RA among eligible adults with T2D across specialty visits. Eligibility included atherosclerotic cardiovascular disease (ASCVD), heart failure, or diabetic nephropathy for SGLT-2i and ASCVD for GLP-1RA. Detailed demographic and comorbidity information was obtained from the year before cohort enrollment.Results:Among eligible individuals for SGLT-2i (N=294,988) and GLP-1RA (N=198,525), 10.4% and 16.7% initiated these medications during the study period, respectively. Overall, 57% of those with an indication for SGLT-2i and 64% for GLP-1RA had at least one visit with a cardiologist. After accounting for differences in clinical characteristics and comorbidities, those with a visit with a cardiologist had higher odds of initiating SGLT-2i (OR = 1.26 [1.21-1.30]) and GLP-1RA (OR=1.05 [1.01-1.10]). However, these were not higher than those receiving care from family medicine and internal medicine providers and were substantially lower than those receiving care from an endocrinologist (Figure).Conclusion:In 2019-2020, among insured individuals with compelling CV indications, despite broad access to cardiovascular care, receiving care from cardiologists was only modestly associated with uptake of novel therapies. Efforts to improve the use of these medications are less likely to benefit from efforts to broaden access to specialty cardiovascular care.

Circulation, Volume 146, Issue Suppl_1, Page A12781-A12781, November 8, 2022. Introduction:Limited access, due to geographic and/or transportation barriers, is one of the most significant challenges to chronic disease management in rural areas. Remote monitoring is a potential solution that allows a patients’ implanted devices to be interrogated for arrhythmia and non-invasive hemodynamics without the patient travelling to clinic. The aim of this study is to describe recent trends in remote monitoring among patients with HFrEF and to identify barriers and expand access in rural areas.Methods:We created annual, cross-sectional cohorts of patients with HF in each year from 2013 to 2018 with approximately 5 million patients/year by requiring ≥1 inpatient or ≥2 outpatient ICD9/10 codes for HF in the 2 years prior. Remote interrogation was determined using ICD-9/10 and CPT codes. Rurality was determined using the beneficiaries’ ZIP code of residence and the Rural/Urban Commuting Areas (RUCA) classification. The outcome of interest was the number of HFrEF patients with ≥1 remote monitoring visit in each year between 2013 and 2018.Results:The use of remote monitoring increased 21% between 2013 and 2018 in patients with HFrEF. By 2018, 9.3% of patients had ≥1 remote monitoring event (Figure 1). After multivariable adjustment for patient factors, living in a rural area was associated with a 14% greater odds (95% CI 1.13, 1.14, p

Circulation, Volume 146, Issue Suppl_1, Page A14609-A14609, November 8, 2022. Introduction:Infective endocarditis (IE) after cardiac valve surgery is associated with high morbidity and mortality. Nosocomial exposure is a growing cause of IE in general. We investigated the risk of post valve surgery endocarditis (PVE) in patient who had any hospitalization and specific nosocomial exposures after open heart valve surgery.Methods:We identified all ≥18yo patients who had their first open heart cardiac valve surgery between 2001-2017 in New South Wales, Australia from the Admitted Patient Data Collection (APDC) registry. Patients with prior/current IE diagnosis at time of index valve surgery were excluded. Follow up was until 31 Dec 2018 with mortality and morbidity tracked from the respective death and APDC registries. Analyses based on Cox regression modelling included age, sex, background diagnoses and features of index valve surgery as time independent covariates, with any hospitalization (separately for specific invasive procedures) post index valve surgery as time dependent exposure covariates for risk of PVE within 6 months of exposure.Results:In total 23747 patients (median age [IQR] 73yo [65-79yo, 63% male) had cardiac valve surgery: 60% isolated aortic valve (n=15065), 28% isolated mitral valve (n=6702), 10% multiple valves (n=2385) and 1.5% right sided valves (n=357). 5.4% (n=1293) of patients experienced PVE at a median 2.9 years (IQR 0.7-6.2) after index valve surgery, with 65% (n=838) occurring within 6 months of any hospitalization. Any hospitalization exposure was associated with an adjusted hazard ratio of 4.0 for developing PVE (95% confidence interval 3.5-4.5). In addition, specific invasive procedures including repeat valve surgery were associated with an elevated risk for PVE (Figure).Conclusions:PVE is significantly more common after any hospitalization with specific invasive procedures carrying differential risk. Care should be taken to avoid unnecessary hospitalizations and procedures in these patients.

Circulation, Volume 146, Issue Suppl_1, Page A13174-A13174, November 8, 2022. Introduction:Heart failure with preserved ejection fraction (HFpEF, EF >50%) syndrome is often associated with hypertension, hyperlipidemia, obesity, and diabetes. Morbidity and mortality in patients with HFpEF are similar to those with heart failure with reduced ejection fraction, however therapies are scarce. Mouse models used to understand sarcomere dysfunction in HFpEF and to identify new targets are needed. In this study we challenged young mice with volume overload and metabolic perturbations induced by high fat diet (HFD) to harbor the conditions of HFpEF.Methods:C57BL/6N 16-weeks old female and male mice were treated with subcutaneous pellets of controlled released DOCA (Deoxycorticosterone Acetate, 0.71 mg/d), drinking water with 1% saline and HFD for a period of 3 weeks to induce obesity and mild hypertension. Cardiac function was evaluated at baseline (before treatment) and 2 and 3 weeks after treatment. Body weight, % fat mass, %lean mass, glucose tolerance test, and lipid profile were also evaluated at baseline and 3 weeks after treatment.Results (Table): Treatment induced diastolic dysfunction measurable by echocardiography at 3 weeks with slower peak myocardial relaxation velocity (e’), increased peak blood inflow velocity at early diastolic filling E/e’ ratio, increased E/A ratio, and increased isovolumetric relaxation time (IVRT). Meanwhile ejection fraction is preserved. As expected HFD feeding elicited body weight increase with increased fat mass accumulation associated with decreased lean mass, glucose intolerance and hypercholesterolemia.Conclusions:This study describes a mouse model of HFpEF that only requires 3 weeks of treatment with DOCA, 1% saline drinking water and HFD. This model reproduces the most common comorbidities of HFpEF such as diastolic dysfunction, obesity, glucose intolerance, and hypercholesterolemia, and may be used to understand the molecular pathophysiology of HFpEF.

Circulation, Volume 146, Issue Suppl_1, Page A12833-A12833, November 8, 2022. Introduction:Health information collected during research studies is rarely returned to patients although it can provide benefits for ongoing clinical management. Little is known about preferences for data access and sharing from older adults with heart failure.Methods:The research team developed an interview guide based on participants’ perspectives on the ethical implications of data sharing and access in research studies. Interview length ranged from 20-40 minutes each. Qualitative data were analyzed using a directed content analysis approach. Two authors double-coded the first 10% of transcripts and discussed discrepancies to consensus, consulting additional reviewers at weekly meetings when needed.Results:Overall, 22 participants were recruited and the mean age was 72 (56-75) years, 27% were female, 14% were Hispanic/Latino, the majority were highly educated (95% completed college or above), and also reported a disability (54%). The three primary themes on the facilitators to data access and sharing were: support for self-management, enhancing clinician communication and motivation to help others (Table). The three primary themes on barriers to data access and sharing were: fear of loss of health insurance benefits, privacy concerns, and a lack of confidence interpreting complex health information.Conclusions:Older adults with heart failure strongly endorsed a preference for having access to health research information and being able to share that information with healthcare professionals to optimize management of their care. Psychological barriers to meaningful use of health information can be addressed through transparency with data use and access.

Circulation, Volume 146, Issue Suppl_1, Page A13135-A13135, November 8, 2022. Introduction:Lipoprotein (a) [Lp(a)] is a peculiar lipoprotein species containing a unique glycoprotein apolipoprotein(a) [apo(a)] encoded by theLPAgene. Lp(a) is causatively, independently and significantly associated with CAD and calcified aortic valve stenosis. MiRs are approximately 22 nucleotides in length and work by inducing RNA silencing, thus reducing target genes expression. The influence of these regulatory elements on the expression ofLPAremains unknown.Hypothesis:Apo(a) and Lp(a) plasma levels are genetically regulated by miRs.Method:A prediction software was used to identify miR candidates targeting the humanLPAmRNA open reading frame (ORF). We investigated the selected candidates by transfecting these miRs (i) in HEK293 cells stably expressing a shortLPAisoform (i.e. 17 KIV domains) and (ii) in the Hep3B human hepatoma cell line that endogenously expressLPA. A validated siRNA targetingLPAand a scrambled siRNA were used as positive and negative controls, respectively.LPAexpression was assessed by RT-qPCR. Apo(a) protein expression and secretion in the culture medium were assessed by Western Blot and ELISA, respectively.Results:We identified four miR candidates (miR22, miR194, miR218, and miR455) based on sequence complementarity between their seed region and theLPAmRNA ORF. Compared with the negative control, only miR455 significantly reducedLPAmRNA expression (-67±8%) as well as apo(a) intracellular abundance (-41±9%) and apo(a) secretion (-36±9%) in the culture medium (p

Circulation, Volume 146, Issue Suppl_1, Page A11549-A11549, November 8, 2022. Introduction:Lower rates of transcatheter aortic valve implantation (TAVI) among Black individuals have been observed, the drivers of this disparity remain poorly understood. We studied the association between county-level racial segregation and rates of aortic stenosis (AS) diagnosis and management.Methods:We identified Black and white Medicare fee-for-service beneficiaries living in metropolitan areas between 2016 and 2019. Using the American Community Survey’s residential segregation index (SI), a measure of geographic distribution of Black and white residents ranging from 0 (complete integration) to 100 (complete segregation), we determined segregation in each beneficiaries’ county of residence. We calculated population-level rates of AS diagnosis and TAVI using validated ICD-10 codes. Using hierarchical modeling, we determined the association between racial segregation and rates of AS diagnosis, TAVI receipt, and 30-day mortality.Results:A total of 29,264,075 beneficiaries were included in the analysis. Living in a high-segregation county (SI >60) was associated with increased rates of AS diagnosis overall (adjusted OR 1.03 95%CI 1.02-1.03) but no difference in TAVI. However, among Black beneficiaries, increasing county-level segregation was associated with decreased rates of AS diagnosis and TAVI; the opposite association was observed among white beneficiaries (Figure 1). Among those with an AS diagnosis, the interaction between Black race and segregation, and lower rates of TAVI persisted (interaction p-value 0.003). Segregation and race were not independently associated with 30-day mortality.Conclusions:Living in a high-segregation county is independently associated with decreased population-level rates of AS diagnosis and receipt of TAVI for Black, but not white, individuals. Among Black people living in high-segregation counties, disparities in TAVI rates are associated with decreased AS diagnosis and access to TAVI.

Circulation, Volume 146, Issue Suppl_1, Page A11530-A11530, November 8, 2022. Introduction:Standard of care (SOC) anticoagulation for thromboembolism (TE) prevention in patients

Circulation, Volume 146, Issue Suppl_1, Page A15812-A15812, November 8, 2022. Introduction:In October 2018, the heart allocation policy for adult heart transplant (OHTx) in the United States was changed, with the goal of reducing waitlist mortality and providing broader sharing of donor organs within the United States. The aim of this study was to assess the effect of this policy change on access to OHTx vs LVAD, overall and among key sociodemographic subgroups, in the US from 2016 to 2019.Hypothesis:We hypothesized that the UNOS heart allocation policy would increase OHTx volume overall as well as use of temporary mechanical circulatory support.Methods:We identified all patients receiving OHTx or LVAD between 2016-2019 using the National Inpatient Sample. Controlling for medical comorbidities, trends over time, and within hospital-year effects, we fit a dynamic logistic regression model to evaluate patient and hospital factors associated with receiving OHTx vs LVAD pre- versus post-policy change.Results:We identified 2264 patients who received OHTx and 3157 who received LVADs during the study period. Overall, there was a 4.16% increase in OHTx receipt, compared to LVAD, in the post-period (p=0.006). Among OHTx recipients, the frequency of use of tMCS changed from 15.61% in the pre period to 42.55% in the post period (p-value < 0.0001). While the policy change was associated with differences in the odds of receiving an OHTx versus LVAD between different regions of the country, there were no significant changes based on age, gender, race/ethnicity, insurance status, or rurality.Conclusions:The UNOS policy change on access to OHTx was associated with slightly higher rates of OHTx overall, and higher rates of use of temporary support prior to transplant, but no differential change in access among key demographic groups. Shifts in regional allocation were not significant overall, though certain regions appeared to have a relative increase in their use of OHTx.

Circulation, Volume 146, Issue Suppl_1, Page A13986-A13986, November 8, 2022. Background.Cangrelor is an intravenous P2Y12 inhibitor with an immediate onset of action and a short half-life. Its use seems especially attractive in patients who cannot swallow oral drugs, e.g. after CPR or in cardiogenic shock.Purpose.To determine the efficacy and safety of the intravenous P2Y12 inhibitor cangrelor undergoing PCI after prehospital cardiopulmonary resuscitation (CPR) and/or cardiogenic shock (CS) in real life.Methods:The CAN-SHOCK registry included patients undergoing PCI for acute myocardial infarction after CPR. Baseline characteristics, procedural features, and in-hospital outcomes were centrally collected and analysed. The primary endpoint was the incidence of stent thrombosis and/or myocardial reinfarction until 48 hours after PCI.Results.A total of 303 patients were included in 10 centers in Austria and Germany. The inclusion criteria were CPR before PCI (n=169, 55.8 %), cardiogenic shock (n=68, 22.4 %) and CPR and cardiogenic shock (n=59, 19.5 %). The baseline characteristics, in-hospital procedures and outcomes are listed in the table.Conclusions.In this large multicentre registry cangrelor in patients undergoing PCI after CPR and/or CS cangrelor was effective in preventing stent thrombosis and re-infarction and associated with an acceptable bleeding rate.

Circulation, Volume 146, Issue Suppl_1, Page A11496-A11496, November 8, 2022. Introduction:Use of radial access for chronic total occlusion (CTO) percutaneous coronary intervention (PCI) has been increasing.Methods:We examined the clinical characteristics and procedural outcomes of patients who underwent CTO PCI with radial versus femoral access in the Prospective Global Registry for the Study of CTO Intervention (PROGRESS-CTO, NCT02061436).Results:Of 10,954 patients who underwent CTO PCI at 55 centers in 7 countries between 2012 and 2022, 2,578 (24%) had a radial-only approach. Patients who underwent radial-only access were younger (63 ± 10 vs. 65 ± 10, years, p

Circulation, Volume 146, Issue Suppl_1, Page A13171-A13171, November 8, 2022. Introduction:The effect of the COVID-19 pandemic on availability of and participation in cardiac rehabilitation (CR) participation is unknown.Methods:We used Medicare Fee-for-Service claims, American Hospital Association surveys, and Rural Urban Commuting Area codes to evaluate CR center availability and CR participation (01/2019-12/21).Results:Medicare beneficiaries participated in a mean ± SD of 56,898 ± 2,046 CR sessions per month from 01/2019 – 02/2020. Immediately after the announcement of the public health emergency in 03/2020, CR sessions declined by 93% (to 3,989 sessions in 04/2020) (Figure). The monthly CR sessions recovered gradually through 12/21, but CR participation remained 17% lower than pre-pandemic levels (54,730 ± 2,340 sessions/month in Q1 2019 vs. 45,209 ± 326 sessions/month in Q4 2021, p