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 4138093: Impact of Pre-Existing Cardiovascular Diseases on Severe Maternal Morbidity and Mortality During Delivery in Pregnant Women with Atrial Fibrillation

Circulation, Volume 150, Issue Suppl_1, Page A4138093-A4138093, November 12, 2024. Background:While the incidence of atrial fibrillation (AF) among pregnant women is increasing, the impact of pre-existing cardiovascular disease (CVD) on pregnant women with AF is not well-described in a large national database.Objective:This study aimed to compare pregnancy outcomes between those with AF alone and those with AF and pre-existing CVD categorized by the modified World Health Organization classification (mWHO).Methods:We used the Nationwide Readmissions Database and included all pregnant women with AF (2017-2020). We categorized the cohort into two groups depending on the presence of pre-existing CVD. We assessed the risk of severe maternal morbidity and mortality (SMM) outcomes, as defined by the CDC, between pregnant women with AF alone and those with AF and pre-existing CVD.Results:Out of the total 2,348 pregnant women with AF, 348 (14.8%) had pre-existing CVD. 69 (19.8%) had mWHO I- II CVD, 150 (43.1%) had mWHO II/III- IV CVD, and 129 (37.1%) had CVD not classified in mWHO. Overall, those with pre-existing CVD had higher rates of SMM/death (28.2% vs. 11.1%, P

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Novembre 2024

Abstract 4140984: Palliative Care Interventions Effect on Quality of Life and Symptoms in Patients with Heart Failure: An Updated Systemic Review and Meta-analysis

Circulation, Volume 150, Issue Suppl_1, Page A4140984-A4140984, November 12, 2024. Introduction:Heart failure (HF) is a prevalent medical condition, affecting approximately 6.7 million Americans. Patients with HF frequently experience comorbidities such as depression and anxiety, which can lead to diminished quality of life. According to the World Health Organization (WHO), palliative care may be beneficial for these patients in addressing their complex physical, mental, and social needs. Therefore, an assessment of palliative care involvement in HF patients is warranted to determine its impact on improving quality of life, alleviating symptoms such as dyspnea, depression, and anxiety.Hypothesis:The aim is to assess the impact of palliative care interventions on the quality of life, dyspnea, anxiety, and depression in patients with HF.Methods:A systematic review and meta-analysis were conducted on clinical trials retrieved from Scopus, Cochrane, PubMed, Embase, and Web of Science databases from their inception until March 2024. Studies reporting on the impact of palliative care interventions on the quality of life of patients with HF were included. The primary outcome was the effect on quality of life, while the effects on dyspnea, depression, and anxiety were secondary outcomes. Data from the studies were pooled using RevMan V5.4, and changes in the mean difference from baseline and confidence intervals (CI) were calculated for each outcome.Results:The meta-analysis included eleven studies, predominantly randomized controlled trials, with a total of 1662 participants, 812 of whom received palliative care interventions. The analysis revealed a significant improvement in the mean change from baseline within the intervention group compared to usual care. Specifically, the quality of life showed a mean difference change from the baseline of 1.35 (95% CI: 0.88 to 1.82), anxiety improved with a mean difference change from baseline of 0.30 (95% CI: 0.03 to 0.58), and dyspnea showed a mean difference change from baseline of 1.0 (95% CI: 0.74 to 1.26). However, there was no significant difference in the mean change from baseline for depression between both groups.Conclusion:Palliative care interventions are associated with significant improvements in quality of life, anxiety, and dyspnea in patients with heart failure compared to usual care. However, there is no significant impact on depression. These findings support the integration of palliative care into the management of heart failure patients to enhance their overall well-being.

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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 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 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 4119613: Evaluation of Gender, Racial and Ethnic Differences in Time to PCI in the Pre and Post Covid-19 Era

Circulation, Volume 150, Issue Suppl_1, Page A4119613-A4119613, November 12, 2024. Introduction:Percutaneous Coronary Intervention (PCI) is recommended for reperfusion of patients presenting with ST-segment myocardial infarction (STEMI) within 90 minutes. In this study, we sought to identify differences in PCI timing based on gender, race and ethnicity in the pre- and post-COVID era.Methods:We collected retrospective data on 760 patients admitted with STEMI at our quaternary academic medical center from 2018-2022. We defined our binary outcome as time to PCI less than 90 minutes, and adjusted for transfers from outside hospitals. We utilized univariate logistic regression analysis to analyze the association of demographic, clinical, and cardiac catheterization details on our outcome. We then utilized multivariate logistic regression analysis to determine the association of our covariates of interests with time to PCI. The logistic regression model was adjusted for collinearity which were deemed not significant.Results:Among our study population, COVID did not significantly impact whether or not a patient had a diagnostic cardiac catheterization on univariate analysis (OR 2.68, 95% CI 0.61-18.40, p=0.23). However, the post-COVID era was significantly associated with a delayed time to PCI on multivariate analysis [OR 1.62, 95% CI 1.04-2.55, p=0.035) [Figure 1]. In addition, females were 1.8x more likely to have a delayed PCI than males on multivariate regression [OR 1.80, 95% CI 1.10-2.95, p= 0.019) [Figure 1]. Interestingly, on multivariate analysis, females were more likely to have delayed reperfusion in the pre-COVID era (OR 2.92, 1.29-6.77,p= 0.01) but not the post-COVID era (OR 1.54, 0.78-3.06,p=0.2134). Patients in the post-COVID era had increased risk of having their culprit coronary not revascularized on multivariate analysis (OR 2.85, 1.2-8.03, p= 0.03).Conclusions:At our center, COVID did not significantly impact cardiac catheterization rates. However, COVID was significantly associated with delayed reperfusion timing and not revascularizing culprit vessels. Females were much more likely to have a delayed PCI than males in the pre-COVID era which was not seen following COVID-19.

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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 4142988: Effectiveness of Additive Cardiac Computed Tomography Angiography for Pre-procedural Planning of Left Atrial Appendage Occlusion: A Systematic Review and Meta-Analysis

Circulation, Volume 150, Issue Suppl_1, Page A4142988-A4142988, November 12, 2024. Introduction:The latest expert consensus on catheter-based Left Atrial Appendage Occlusion (LAAO) suggests considering either transesophageal echocardiography (TEE) alone or the addition of Cardiac Computed Tomography Angiography (CCTA) for pre-procedural planning. However, evidence comparing the effectiveness of adding CCTA to regular TEE planning on procedural success is limited.Methods:We aimed to perform a systematic review and meta-analysis to determine the impact of adding CCTA to regular TEE for pre-procedural planning in patients undergoing LAAO. We systematically searched Cochrane, Embase, and Medline for observational studies and randomized controlled trials (RCTs) comparing TEE alone to TEE with the addition of CCTA. The primary endpoint was procedural success. Risk ratios (RRs) with 95% confidence intervals (CIs) were pooled across studies using a random-effects model.Results:Four studies were included in our meta-analysis, three of which were RCTs and one observational study, comprising a total of 824 patients, of whom 496 (60.2%) underwent additional CCTA. In the pooled analysis, procedural success was higher in the group with added CCTA (RR 1.10; 95% CI 1.01 – 1.19; p=0.022; I2=52%). A subgroup analysis of RCTs alone confirmed these findings, with a slightly higher magnitude of effect in benefit of the addition of CCTA, and with lower heterogeneity (RR 1.15; 95% CI: 1.06 – 1.25; I2 = 0%).Conclusions:In this meta-analysis comparing TEE alone vs TEE with the addition of CCTA for preprocedural planning of LAAO, the addition of CCTA was associated with a higher procedural success rate, and this finding was confirmed in a subgroup analysis of randomized data.

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Novembre 2024