FUPEC study, a prospective open-cohort on severe pre-eclampsia and cardiovascular risk factors based in the Netherlands

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.

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Novembre 2024

Abstract 4140154: Highly Sensitized Heart Transplant Recipients Who Have Undergone Pre-Transplant Desensitization Therapies Demonstrate Acceptable Medium-Term Outcomes

Circulation, Volume 150, Issue Suppl_1, Page A4140154-A4140154, November 12, 2024. Introduction/Research Question:Allosensitization, the presence of circulating anti-HLA antibodies, is a barrier in heart transplantation (HT), restricting the donor pool size, and leading to increased waitlist mortality and rejection risk post-HT. Desensitization therapies can be used to broaden the donor pool in highly sensitized patients, defined as pre-HT calculated panel reactive antibodies (cPRA)≥50%, for antibodies with mean fluorescence intensity (MFI) >10,000. There is paucity of data on longer-term outcomes in such high-immunological risk patients.Methods:Sensitized patients with pre-HT cPRA >50%, who were treated with desensitization and then received HT between 2011-2022 at Cedars-Sinai Medical Center were included. Desensitization therapies included bortezomib, rituximab, tocilizumab, obinutuzumab, intravenous immunoglobulin (IVIG), and plasmapheresis. cPRA, donor-specific antibody (DSA) levels, and post-HT clinical outcomes were assessed up to 5-year follow-up, loss to follow-up, or death.Results:40 patients were analyzed. 77.5% of patients were female, and all had at least 1 risk factor for sensitization. cPRA decreased from 84.5±13.5% at baseline to 74.1±22.4% after completion of desensitization therapy, prior to transplant (p=0.005). Mean follow-up time post-HT was 4.3±2.9 years. 45.0% of patients had antibody-mediated rejection (AMR), 12.5% had CAV. Overall survival was 94.9%, 92.1%, and 87.5% at 1, 3, and 5 years respectively. All patients except 1 had normal left ventricular function at last follow-up. 72.5% of patients were transplanted in the presence of DSA, and 60.0% underwent post-HT induction with eculizumab in addition to antithymocyte globulin (ATG)/IVIG, while the remaining received ATG/IVIG alone. Among HT recipients with pre-formed DSA, 41.4% had high-level DSA (MFI > 10,000) at time of HT. At 6-12 months post-HT, only 17.2% had high-level DSA, and 41.4% had resolution of DSA.Conclusion:Highly sensitized HT candidates who underwent pre-HT desensitization had comparable survival and CAV rates as compared to the general HT population reported in the literature. However, sensitized patients experienced higher rates of AMR which were not associated with graft dysfunction or mortality.

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Novembre 2024

Abstract 4143224: Feasibility of Left Atrial Appendage Occlusion with Dual-Seal Technology without Pre-Procedural CT: Early Single-Center Experience

Circulation, Volume 150, Issue Suppl_1, Page A4143224-A4143224, November 12, 2024. Background:Left Atrial Appendage (LAA) Occlusion with Amulet has shown promising results in achieving complete closure with minimal periprocedural leak. Amulet’s dual-sealed technology and numerous sizing options provide versatility for different LAA morphologies. Pre-procedural CT is routinely recommended for pre-procedural planning. However, this brings risks including use of contrast, risk of renal failure, radiation exposure, and patient inconvenience. Here, we share initial results of our Amulet implantation protocol without pre-procedural CT: 83 cases were reviewed; number of devices used, procedural time, periprocedural bleeding complications, success in coming off oral anticoagulation, and incidences of stroke and embolism were followed.Methods:We followed 83 AF patients who underwent LAA closure with Amulet, implanted with intraprocedural TEE, intracardiac left atrial echocardiography, and intraprocedural angiography. Pre-procedural CT was not used. Patients were followed to assess safety and efficacy of this protocol. Safety endpoints included rates of procedural and bleeding complications. Efficacy endpoints included rates of stroke and embolism, and number of devices used.Results:All 83 procedures were successfully completed with no perioperative procedural complications and no documented leaks on follow-up TEE. Patients had early ambulation with closure. On average, 1.14 devices were used per case: 88% of cases required 1 device, and nine cases required 2 devices; one case required 4 devices to fit as patient was noted to have an interrupted IVC, requiring implantation via right IJV. There were no cases of stroke or embolism following implantation, and all patients were safely able to come off oral anticoagulation.Conclusions:Results demonstrate that Amulet with its dual-sealed technology can be effectively and safely implanted without pre-procedural CT. No perioperative complications were observed. 88% of cases closed with single device usage. No post-procedure leaks were noted on follow-up TEE. Safety endpoints revealed minimal adverse events, with 2 cases of late pericardial effusion managed without long-term consequences. This protocol demonstrated high efficacy, as all patients were successfully able to come off oral anticoagulation with no reported strokes or embolic events. Intraprocedural TEE, intracardiac left atrial echocardiography, and intraprocedural angiography are typically appropriate for periprocedural sizing of the device.

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Novembre 2024

Abstract 4124342: Invasive CPET-based hemodynamic correlates of abnormal peak VO2 and VE/VCO2 in HFpEF and pre-capillary Pulmonary Hypertension

Circulation, Volume 150, Issue Suppl_1, Page A4124342-A4124342, November 12, 2024. Introduction:Pulmonary hypertension (PH) is a heterogeneous disease characterized by impaired gas exchange (CO2, O2) in the pulmonary circulation, leading to dyspnea and exercise intolerance. We hypothesize that specific hemodynamic metrics correlate with poor gas exchange in PH phenotypes, which can be leveraged to define therapeutically relevant hemodynamic targets.Aim:This study aims to define hemodynamic correlates of poor gas exchange (peak VO2, VE/VCO2slope) in heart failure with preserved ejection fraction (HFpEF) and pre-capillary PH.Methods:We retrospectively analyzed 170 participants with invasive cardiopulmonary exercise testing: HFpEF (n=91), pre-capillary PH (n=54), and non-cardiac dyspnea (NCD, n=25). Linear regression models, adjusted for patient groups with interaction, were used to assess the association of peak VO2and VE/VCO2slope with predictors (pulmonary vascular resistance [PVR], distensibility, and pulmonary arterial compliance [PAC]).Results:In the order of NCD vs. HFpEF vs. pre-capillary PH, rest PAC (5.5±1.6 vs 3.8±1.7 vs 2.6±1.3 mL/mmHg), rest PVR (1.4±0.6 vs 3.2±2.0 vs 5.7±3.0 Woods unit), and distensibility (1.5±0.5 vs 0.8±0.4 vs 0.5±0.2 % per mmHg). In comparison to a non-significant correlation with rest PVR and distensibility, peak VO2(%predicted) showed significant correlation with rest PAC (p

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Novembre 2024

Abstract 4136013: Pre-operative Frailty Status and Short-term Complications Among Adults Undergoing Transcatheter Aortic Valve Replacement

Circulation, Volume 150, Issue Suppl_1, Page A4136013-A4136013, November 12, 2024. Introduction:The use of Transcatheter Aortic Valve Replacement(TAVR) has provided a safer alternative to open surgical approaches. The introduction of frailty scoring systems has proven effective in improving healthcare approaches and outcomes in various aspects of medicine. As there is a paucity of data on the impact of frailty among TAVR patients, we aim to conduct a retrospective study to investigate further.Methods:Our study analyzed adult cases with a primary procedural code for TAVR among hospitalizations between 2016 and 2021 through the National Inpatient Sample(NIS). Frailty status was explored through the criteria of Gilbert’s frailty index. Multivariable regression models helped evaluate differences in short-term outcomes and complications between them.Results:Our study involved 374200 cases of TAVR that were divided into LFR(285425 cases, 76.3%), IFR(86005 cases, 23.0%), and HFR(2770 cases, 0.7%). Compared to patients with LFR, patients with MFR and HFR showed higher odds of several complications, including cardiogenic shock(MFR: aOR 6.933, p

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Novembre 2024

Abstract 4144651: Association Between Pre-Existing Chronic Total Occlusion and Post-TAVR Pacemaker Implantation: A Retrospective Propensity Matched Analysis

Circulation, Volume 150, Issue Suppl_1, Page A4144651-A4144651, November 12, 2024. Introduction:Post-transcatheter aortic valve replacement (TAVR) pacemaker (PPM) implantation is a known complication. Chronic total occlusion (CTO) of coronary arteries is common in TAVR patients and is a marker of advanced coronary calcification. Its influence on the requirement for PPM post-TAVR remains unclear. We investigated the association between pre-existing CTO and the incidence of PPM post-TAVR.Methods:A retrospective cohort study was conducted using the National Inpatient Sample database from 2018-2020 with 205,565 patients who underwent TAVR. Propensity score matching was utilized to create a matched cohort of patients with and without CTO, balancing key variables such as age, sex, elective procedure status, and comorbid conditions (heart failure, arrhythmias, pulmonary circulation disorders, peripheral vascular disorders, and complicated diabetes). Outcomes measured included the requirement for PPM implantation post-TAVR, in-hospital mortality, and major adverse cardiac events (MACE). Weighted samples were utilized and p-value

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Novembre 2024

Abstract 4138992: Beta blockers and calcium channel blockers in pre-symptomatic patients with hypertrophic cardiomyopathy: prevalence, discontinuation, and effectiveness

Circulation, Volume 150, Issue Suppl_1, Page A4138992-A4138992, November 12, 2024. Background:Beta-blockers (BB) and non-dihydropyridine calcium channel blockers (CCB) are first-line therapies for hypertrophic cardiomyopathy (HCM) used both upon symptom onset and for pre-symptomatic patients. However, there is limited evidence supporting their efficacy, particularly from randomized controlled trials.Aims:In this study we assessed the prevalence, discontinuation rates, and effectiveness of BB/CCB for NYHA class I HCM patients.Methods:Utilizing data from a real world cohort spanning 4 centers, we evaluated BB/CCB effectiveness in NYHA class I patients with HCM. The effectiveness analysis for a composite endpoint (NYHA class worsening and cardiovascular-related hospitalization) was performed independently at each center and an aggregated analysis was performed. NT-proBNP level analysis was performed where longitudinal data was available. Patients initiating therapy during follow-up were compared to untreated controls, adjusting for confounders (duration since HCM diagnosis, left atrial volume index (LAVi), E/e’ lateral ratio, medical history, NT-ProBNP levels) using inverse probability weighting and Stürmer trimming. The association between treatment and the risk of composite endpoint was assessed through Cox regression, while mixed models for repeated measures were used for NT-proBNP levels.Results:Among the 735 patients, 64% initiated BB/CCB therapy with a 33% discontinuation rate at 4 years. A total of 222 patients with extreme propensity scores were excluded. As shown in Table 1., no benefit from BB/CCB in reducing the composite endpoint risk (HR=1.08, p=0.79) was observed. This was consistent across the different components of the endpoint. Additionally, no benefit in reducing NT-proBNP levels after 1 year was detected (Least Means Square difference=0.02, p=0.79).Conclusion:Initiation of BB/CCB for NYHA I HCM patients did not appear to reduce the risk of progression measured by the functional capacity, CV hospitalization and NT-proBNP. Despite the inherent limitation of observational studies, these findings together with the high discontinuation rate of the therapy, underscore the need for further research to validate optimal treatment strategies for pre-symptomatic HCM patients.

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Novembre 2024

Abstract 4143328: Safety of Direct current cardioversion without pre-cardioversion imaging in patients presenting post percutaneous left atrial appendage occlusion

Circulation, Volume 150, Issue Suppl_1, Page A4143328-A4143328, November 12, 2024. Background:Direct current cardioversion (DCCV) carries a risk of stroke in atrial fibrillation (AF) patients. Hence, published guidelines for mitigating this risk with oral anticoagulation (OAC). There is no consensus agreement on the safest approach when cardioverting patients with left atrial appendage occlusion device in situ.Aims:We aimed to compare association of pre-DCCV imaging with safety and outcomes in patients with WATCHMAN™ undergoing elective DCCV for atrial arrhythmias (AA)Methods:This was a retrospective cohort study of patients who received DCCV for AA during follow up after LAAO procedure from 2016-2024 within a large health care system. Safety endpoint was freedom from stroke, all-cause mortality, device embolism, and systemic embolism within 30-days post DCCV. Significant peri-device leak (PDL) was defined as > 5mm on cardiac imaging.Results:A total of 119 patients were included, more females 70 (59%), with more than half (64 (54%)) receiving a first-generation WATCHMAN™ 2.5, while the rest had WATCHMAN FLX™. Median age at presentation was 77 years (72,82), BMI of 31 kg/m2 (26,37), average CHADSVASC score of 4.5 and HASBLED score of 3. There was a median duration of 10 months (3,21) between LAAO to presentation for DCCV .Forty-four (37%) patients had pre-DCCV imaging, while 75 patients did not receive pre-procedural imaging. Between the two groups, there was no significant difference in OAC (VKA-antagonist/DOAC) usage prior to presentation (8 (18.6%) vs 12 (16.4%), P=0.9), with single antiplatelet therapy was the prevalent anti-thrombotic regimen. There was no significant difference in CHADSVASC, HASBLED, age, LVEF, or timing of presentation relative to the LAAO procedure. Higher percentage of patients were discharged on OAC post DCCV in the imaging cohort (13 (30.2%) vs 14 (19.4%), p=0.27), the difference was not significant. No Device related thrombus (DRT) nor significant PDL was detected on imaging. But non-significant PDL ranging from 2mm-4.7mm was found in 8 (18.1%) out of 44 patients who had imaging prior to DDCV. Safety endpoint was achieved in both cohorts with zero adverse events occurring during the 30 day follow up period post-DCCV.Conclusion:Elective cardioversion for atrial arrhythmias is safe in patients with WATCHMAN™. There were no post-DCCV stroke events in the overall cohort and no DRT identified in the pre-DCCV imaging subgroup. Further studies are needed to determine when pre-DCCV imaging is warranted in this population.

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Novembre 2024

Abstract 4143354: Novel Methods Improve Assessment of Virtual Reality’s Impact on Physician Mental Models During Pre-Surgical Planning

Circulation, Volume 150, Issue Suppl_1, Page A4143354-A4143354, November 12, 2024. Background:Virtual Reality (VR) has found numerous applications in healthcare, including 3D presentation of patient anatomy modeled from traditional medical imaging. While individual VR systems have been evaluated for their utility in pre-surgical planning, there remains a gap in understanding of the impact VR has on physicians’ mental models. VR is often assessed on performance criteria, omitting relevant perspectives of the physician’s experience.Research Questions:We sought to explore the following: 1) How does VR affect physicians’ perceptions of complex congenital heart cases, and 2) What strategies do physicians employ while exploring patient anatomy in VR.Goals and Aims:The aim of this study was to analyze how mental models change after reviewing anatomy in VR, and to describe common patterns of behavior in VR which provide deeper insight into the complex task of pre-surgical planning.Methods:We deployed a novel methodology of undirected think-aloud sessions in VR which we anchored to pre and post-session questionnaires based on the NASA Task Load Index. VR sessions were recorded in first-person view and were qualitatively analyzed by five independent coders using a grounded theory approach where codes emerged from the data. Iterative refinement of codes led to identification of multiple patterns of behavior which were summarized thematically. Pre and post-session surveys were analyzed statistically.Results:10 VR sessions were captured from 3 physicians totaling 2.5 hours of recordings. Physician confidence in their understanding of the anatomy increased from a mean of 4/5 before VR to 5/5 after (p=0.012). Themes emerging from VR sessions included: 1) Exploration of the 3D environment led to confirmation of understanding and complex decision making, 2) Emotions expressed in VR reflected strengths and weaknesses of the VR tool, and 3) Confidence may mask complex decision making crucial to the surgical planning process. Reported mental, physical, and time demands of VR all remained low (

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Novembre 2024

Abstract 4146528: Pre-Heart Transplant Physical Rehabilitation in Patients on Impella Support Improves AMPAC Scores and Functional Status

Circulation, Volume 150, Issue Suppl_1, Page A4146528-A4146528, November 12, 2024. Introduction/Background:Patients with heart failure and those waiting for a heart transplant often experience a significant decrease in their ability to perform daily activities and exercise, leading to a lower quality of life. Although exercise-based cardiac rehabilitation (EBCR) is a possible treatment option, its effectiveness has not been well measured, resulting in limited adoption.Research Questions/Hypothesis:Could physical rehabilitation before receiving a heart transplant improve functional status and better outcomes?Goals/Aims:Our objective is to evaluate the effect of pre-transplant physical therapy on the standardized improvement of AM-PAC scores, measured from the earliest pre-transplant assessment to the most recent pre-transplant evaluation. Our second objective is to assess the impact of the latest Pre-Transplant AM-PAC Score on the number of hospital-free days following transplantation.Methods:We conducted a retrospective study on 91 heart transplant patients who received Impella support from January 2019 to April 2023, approved by the Mayo Clinic Institutional Review Board. We collected data on demographics, AMPAC scores, and outcomes at three time points. Continuous variables were compared using the T-test or Mann-Whitney test, and categorical variables using the Chi-square or Fisher’s exact test. We used a linear regression model to investigate the relationship between rehabilitation duration and AMPAC scores. Quantile regression was preferred due to the non-normal distribution of the outcome, hospital-free days.Results:We conducted a linear regression analysis and found a statistically significant association between increased hours spent in PT and greater improvement.After one hour of physical therapy, there was an average increase of 1.07 (95% CI 0.1, 2; p=0.03) in AMPAC scoore. We also compared the change in the AMPAC score with hospital-free days, and it was statistically significant in quantile regression analysis, indicating an increase of 0.28 (95% CI 0.2, 0.55; P=0.03) points in the AMPAC Score, corresponding to an additional hospital-free day.Conclusion:Increased hours spent in physical therapy show a significant positive association with greater improvement in standardized AM-PAC Mobility scores and hospital-free days. These findings encourage increasing uptake and support of cardiac rehabilitation programs.

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Novembre 2024

Abstract 4142895: Artificial Intelligence for Clinical Risk Stratification: Expert Based Risk Scores versus Online Open Source Generative Pre-Trained Transformers

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

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Novembre 2024

Abstract 4146754: The Prognostic Value of Dobutamine Stress Echocardiography in Liver Pre-Transplant Evaluation

Circulation, Volume 150, Issue Suppl_1, Page A4146754-A4146754, November 12, 2024. Background:Dobutamine stress echocardiography (DSE) is a frequently used tool in cardiovascular (CV) risk assessment of liver transplantation (LT) candidates. Its prognostic value compared to traditional cardiac risk stratification remains unclear.Research Question:How does the prognostic value of pre-transplant DSE in LT candidates compare to the revised cardiac risk index (RCRI)?Aim:Compare DSE’s prognostic value to RCRI in LT patients and analyze post-transplant CV outcomes.Methods:This single-center study included adult patients undergoing pre-transplant DSE as part of LT evaluation from 2008-2021. DSE were categorized as positive, negative, or inadequate. Primary outcomes were post-operative ischemic cardiac events and mortality, with secondary outcome of transplant delays from inadequate DSE. Mann-Whitney U and Fischer’s exact tests compared variables; logistic regression assessed RCRI and DSE for 30-day mortality and cardiac events.Results:Of 981 LT candidates, 644 (66%) had pre-transplant DSE with minimum 2-year follow-up. Average age was 57 ± 7 years, with 33% women. Four and eleven patients experienced cardiac events and mortality 1 (p-value 0.50), 0.51 for DSE (p-value 0.82), and 0.52 for RCRI >1 and DSE combined (p-value 0.80) in predicting 30-day mortality and cardiac events.Conclusion:Our study demonstrates limited prognostic value of DSE above RCRI score alone for predicting post-transplant mortality. Inadequate DSE was frequent and extended LT wait times. Further research is necessary to define clinically relevant subgroups and refine CV risk assessment in LT candidates.

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Novembre 2024