To determine the impact of permanent cardiac pacing after transcatheter aortic valve implantation (TAVI) with the CoreValveTM prosthesis in terms of all-cause mortality and morbidity ...rehospitalizations for heart failure (HF) or stroke at the long-term follow-up.
The prospective analysis comprised 259 patients (138 women, 53.3%, age 78 ± 6 years) treated by a CoreValveTM prosthesis from April 2008 to December 2015. Forty-two patients were excluded for analysis: 9 with pre-existing permanent pacemaker (PPM) implantation, 19 who required a PPM during the follow-up and 14 patients because of hospital mortality during or after the CoreValveTM prosthesis implantation procedure. The remaining 217 patients were divided in two groups: Group-1 included those patients who required a PPM immediately after TAVI, and Group-2 included those patients who did not require permanent cardiac pacing at the long-term follow-up. Patients received follow-up at 1-month, 6-months, 12-months, and yearly thereafter. A total of 39 patients required a PPM immediately after TAVI (15.0%), but 178 patients (68.7%) did not. The mean follow-up was 37 ± 27 months (range 3-99 months) in both groups. There was no difference between the two groups in terms of all-cause mortality (52.6% vs. 56.8%, P = 0.125; HR 1.22 0.87-1.77, 95% CI), or stroke (13.3% vs. 15.1% P = 0.842; HR 1.12 0.37-3.32, 95% CI). However, patients who underwent PPM implantation developed an increase in readmissions for HF (21.1% vs. 31.9%, P = 0.015; HR 1.82 1.23-3.92, 95% CI).
Patients requiring a PPM after TAVI did not have an increase in mortality, or an increase in the likelihood of developing a stroke at a long-term follow-up. However, this subgroup of patients showed an increase in rehospitalization due to HF at medium- and long-term follow-up.
The aim of this study was to investigate the absorption profile of tacrolimus (TAC) in heart transplant patients in order to find the best sampling time to predict the total exposure and to explore ...the target range for optimal clinical immunosuppression. Twenty-five full pharmacokinetic studies were performed in 22 heart transplant patients (11 men and 7 women) at less than 1 year posttransplant. The immunosuppressive treatment was steroids plus azathioprine or mycophenolate mofetil and TAC. The mean age was 55 years (36–64 years) and the mean weight 70.49 kg (50–111 kg). After three days of receiving the same dose, eight blood samples were collected at 0.5, 1, 2, 4, 6, 8, and 12 hours postmorning dose. TAC concentrations were measured by microparticle enzyme immunoassay (IMx). Area under the concentration-time curve(AUC
0–12) was calculated by the trapezoidal rule. Using 0–4 hours TAC blood concentrations, a projected 12 hours AUC (extrapolated AUC
0–4) was calculated assuming C
0 and C
12 were comparable. A high interpatient TAC pharmacokinetics variability that was greater during the absorption phase was observed. A Cmax (30.5 ± 13.8 ng/mL) was reached at 2.3 ± 1.5 h. When target trough levels were achieved (10–20 ng/mL), the mean tacrolimus exposure was 230.6 ± 59.2 ng h/mL (120.14–327.7) (
n = 19). Correlation between AUC
0–12 and C
0 was relatively good (
r
2 = 0.74). Between individual time points, C
4 showed the best correlation (
r
2 = 0.88). In any case the best strategy to monitor is to obtain the extrapolated AUC
0–4 (
r
2 = 0.98), as a good approach to patients with a poor response to treatment.
Abstract
Funding Acknowledgements
Type of funding sources: None.
Introduction
Tricuspid regurgitation is a prevalent and undertreated condition. Transcatheter edge-to-edge tricuspid valve repair ...(TTVR E2E) is an emergent option with promising procedural results in clinical trial and selected high-experienced centres. Tricuspid valve (TV) anatomy is highly variable. Whether different morphologies have a clinical or procedural impact over TTVR results are unclear.
Purpose
Our aim is to define the procedural, clinical and echocardiographic results of TTVR E2E technique in a "real-world" population according to TV anatomy.
Methods
We collected all TTVR E2E cases from 8 University Hospitals with large experience in SHDI from 2017 to 2022. It was a prospective inclusion, not randomized (real-world clinical practice). The TV morphology according to Hahn R. et al classification. Different devices (Mitraclip, Triclip & PASCAL) were employed. Clinical and echocardiographic follow-up were collected at 3 & 12 months after index procedure. We defined a combined clinical endpoint of all-cause death, HF admission and TV reintervention
Results
147 consecutive patients were recruited (74 years old, 74% female). The baseline profile was HTN 68%, DM-2 21%, DLP 44%, atrial fibrillation 91%, previous CAD 19% and previous cardiac surgery 42%, COPD 19% and CKD 42%, STS mean 5,8 pts. The TR was ≥severe in all patients (vena contracta mean 12mm, gap size 7mm). According to the procedure, the most employed device was Triclip XT (70%, 1,7 devices/patient, 89% in anteroseptal commissure), with a procedural success of 99% and 93% without clinical complications.
In our cohort, TV anatomy was conformed by 3 leaflets in 56% and 4 leaflets in 37% of cases. The morphology distribution was type I (50%), IIIB (31%), and a much lower frequent distribution of the other types (Figure 1). A significant TR reduction was accomplished in all TV morphologies without significant differences between them (Figure 2). The most frequent morphology (type I) versus the rest of morphologies, not revealed differences in terms of TR reduction or combined clinical endpoint. Restrictive septal leaflet presence (39%) is related with higher partial detachment prevalence (87 vs 17%, p 0,03). No other morphology parameters were related with procedural or clinical endpoint.
Conclusions
TV morphology was highly variable (50% of patients are non-Type I) being type I and IIIB the most prevalent. Posterior leaflet anatomy was the highest variable. Not differences were noted in TR reduction or clinical outcomes according to TV morphology. A restrictive septal leaflet were related with higher prevalence of partial detachment.
Abstract
Background
"Real world" observational data on cardiovascular prognosis of patients with atrial fibrillation and active lung cancer are very limited.
Purpose
Our aim was to describe the ...incidence of major cardiovascular events in this population.
Methods
We used data from CANAC-FA Registry (Active Cancer and Atrial Fibrillation, in Spanish, CÁNcer ACtivo y Fibrilación Auricular), an observational, multicentre, retrospective study. The medical records of all subjects attended at the outpatient oncology clinics solely or mainly attending lung cancer patients from January 1st, 2017 to December 31st, 2019 in five tertiary university hospitals in the south of Spain were reviewed. The first visit to the oncology clinic with atrial fibrillation diagnosis (previous or at that moment), during the first year after the lung cancer diagnosis was considered the basal visit. Follow up period ended at December 31st, 2021. End points were stroke/systemic embolism, thrombotic events (stroke, systemic embolism, pulmonary embolism, deep vein thrombosis), major bleeding (International Society of Thrombosis and Haemostasis definition), and cardiovascular events (hospital admission for cardiovascular reasons or cardiovascular death). Death without the event of interest was considered a competing risk. Calculations were performed with R statistical software, cmprsk package.
Results
Among 6984 patients, 269 presented active lung cancer and atrial fibrillation (3.7%). Mean age was 71±8 years, and 91% were male. Cardiovascular risk factors were: hypertension 77%, dyslipidemia 49%, diabetes 37% and active smoking 30% (62% ex-smokers). Charlson, CHA2DS2VASc and HAS-BLED indexes were 6.7±2.9, 2.9±1.5 y 2.5±1.2, respectively. Tumor stage was I, II, III and IV in 11%, 11%, 34% and 45% of the study sample, respectively. Anticoagulants were prescribed to 84% of the patients: direct anticoagulants (44%), low molecular weight heparins (30%) and vitamin K antagonists (26%). After up to 46 months of maximum follow-up, 7 patients presented a stroke/systemic embolism, 18 had a thrombotic event, 16 presented a major bleeding, 33 had a cardiovascular event and 186 died. Cumulative incidences of major events at one, two and three years of follow-up were 2.4±1.0%, 3.3±1.3% and 3.3±1.3% for stroke/systemic embolism; 4.7±1.3%, 8.0±2.1% and 8.9±2.2% for thrombotic events; 2.7±1.0%, 6.7±1.9% and 9.9±2.6% for severe bleeding, and 9.5±1.8%, 13.4±2.5% and 15.9±3.0% for cardiovascular events (figure).
Conclusions
Cumulative incidence of cardiovascular events was 15.9% at three years in this "real world" population of patients with active lung cancer and atrial fibrillation. These data could suggest an unmet need for more effective preventive strategies in this population.Major events
Abstract
Background
Three scores have been published in 2022 for assessing prognosis of patients with tricuspid regurgitation (TR): the TRI-SCORE, and those reported by Hochstadt and Wang. All of ...them have shown to be useful in the prediction of mortality in follow-up. However only one of them has been externally validated, their comparative performance is unknown, and their discriminative ability for broader outcomes has not been investigated.
Purpose
To perform an external validation of available scores for predicting mortality and the combined end-point of mortality and heart failure (HF) admission in follow-up, in an independent cohort of patients with severe TR, and to compare their discriminative ability for this outcomes.
Methods
The validation cohort included retrospectively all consecutive patients ≥18 years with severe TR studied with echocardiography in a tertiary care hospital from 01.01.2008 to 31.12.2017, followed for all cause death and HF admission up to 01.01.2022. Every score was calculated in each patient with variables from the basal visit (Figure 1), and discriminative ability of the scores for predicting events was assessed by means of receiver operating characteristics (ROC) curves.
Results
A total 661 patients (69±13 years, 72% women) with severe TR, followed for up to 14 years (median 5 years, p25-75 2-7 years) were included in the validation cohort, with 384 deaths and 268 patients with 636 HF admissions on follow up. Discriminative ability for predicting death (C-statistic 0.72, 95%CI 0.68-0.76, p<0.0005 for the TRI-SCORE; 0.75, 95%CI 0.71-0.78, p<0.0005 for the Hochstadt score and 0.72, 95%CI 0.68-0.76, p<0.0005 for the Wang score, figure 1A) or the combined end-point (C-statistic 0.74, 95%CI 0.70-0.78, p<0.0005; 0.74, 95%CI 0.70-0.78, p<0.0005 and 0.73, 95%CI 0.69-0.77,p<0.0005, respectively, figure 1B ) on follow up was statistically significant for all of them. Paired comparison among them for predicting the combined end-point were all non-significant. However, the Hochstadt score was superior to the other two scores for predicting mortality in follow-up (p<0.005).
Conclusions
All tested scores showed significant and similar discriminative ability for predicting the combined end-point of mortality or HF admission in this independent validation study of patients with severe TR. However, the Hochstadt score performed significantly better than the other scores for predicting mortality in follow-upScore variablesROC curves
Abstract
Background
The role of right ventricular-pulmonary arterial coupling, non-invasively evaluated by means of the tricuspid annular plane systolic excursion (TAPSE) and pulmonary artery ...systolic pressure (PASP) ratio in prognostic assessment of tricuspid regurgitation (TR) has been studied only in selected populations and mainly for all-cause mortality.
Purpose
To investigate the value of TAPSE/PASP ratio for predicting the combined end-point of mortality and heart failure (HF) admission in follow-up in a broad population of patients with severe TR, and to compare its discriminative ability with both components of the index separately.
Methods
We included retrospectively all consecutive patients ≥18 years with severe TR studied with echocardiography in a tertiary care hospital from 01.01.2008 to 31.12.2017, followed up to 01.01.2022. Association of TAPSE/PASP ratio with the combined end point and comparative discrimination ability with both components of the index was investigated. The net reclassification indexes for events (NRIe) and non-events (NRIne) were also calculated, with variables dichotomized at median values for establishing risk groups.
Results
A total 661 patients (69±13 years, 72% women) with severe TR, followed for up to 14 years (median 5 years, p25-75 2-7 years) were included in the cohort, with 384 deaths and 268 patients with 636 HF admissions on follow up. Median (p25-75) values for TAPSE/PASP, TAPSE and PASP were 0.34 (0.25-0.44) mm/mmHg, 18 (16-20) mm and 53 (43-65) mmHg, respectively. All three variables were associated with the combined outcome in univariate analysis (figure 1). Discriminative abilities for predicting the endpoint (figure 2A) were statistically significant for all, but TAPSE/PASP performed significantly better than both components separately (p<0.0005). However, after adjusting by other statistically significant prognostic variables, TAPSE/PSAP was not found to be an independent predictor (HR 0.711 0.091-5.555, p=0.75), whereas both components of the index remained in the model (HR 0.945 0.919-0.972, p<0.0005 for TAPSE and HR 1.012 1.007-1.018, p<0.0005 for PASP). The discriminative performance of the three multivariate models including each variable was statistically significant for all (figure 1B) but the model including TAPSE/PASP perfomed similarly to the one including TAPSE (p=0.86) and worse than the one including PASP ((p=0.02). The NRIe and NRIne for TAPSE/PASP versus TAPSE were 5.0% and 0.5%; and 0.4% and 1.3% versus PSAP; these values for multivariate models including TAPSE/PSAP versus TAPSE were 3.1% and 0.4%; and 3.6% and 1.6% versus PASP.
Conclusions
In this broad sample of patients with severe TR, TAPSE/PASP ratio was associated with HF admission or mortality in univariate analysis, and its discriminative ability was higher than any of both components of the index. However, it was not an independent predictor in multivariate analysis.Kaplan-Meier CurvesROC curves
Abstract
Background
Lung cancer has a poor prognosis for most patients, as it is frequently diagnosed in advanced tumour stages. Real world observational data on the impact of major cardiovascular ...events (MACE) and major bleedings (MB) in the prognosis of patients with atrial fibrillation (AF) and active lung cancer are very limited.
Purpose
Our aim was to investigate the impact of MACE and MB in mortality in this population.
Methods
We used data from CANAC-FA Registry (Active Cancer and AF, in Spanish, CÁNcer ACtivo y Fibrilación Auricular), an observational, multicentre, retrospective study. The medical records of all subjects attended at the outpatient oncology clinics solely or mainly attending lung cancer patients from January 1st, 2017 to December 31st, 2019 in five tertiary university hospitals in the south of Spain were reviewed. The first visit to the oncology clinic with AF diagnosis during the first year after the lung cancer detection was considered the basal visit. Follow up period ended at December 31st, 2021. MACE (hospital admission for cardiovascular causes) and MB (International Society of Thrombosis and Haemostasis definition) were registered, and impact on survival was assessed for the whole series and according to tumour stage.
Results
Among 6984 patients, 269 presented active lung cancer and AF (3.9%). Mean age was 71±8 years, and 91% were male. Tumour stage was I, II, III and IV in 11%, 11%, 34% and 45% of the study sample, respectively. Anticoagulants were prescribed to 84% of the patients. After up to 46 months of maximum follow-up, 33 patients presented 40 MACE (13 heart failure admissions, 9 pulmonary embolisms, 5 strokes, 5 severe symptomatic arrhythmias, 4 deep vein thrombosis, 2 transient ischemic attacks, 2 systemic embolisms and 1 acute coronary syndrome), 16 patients had a MB and 186 died. However, two years’ mortality was similar in those patients with MACE or MB in follow-up versus those without them, in the whole of series (79% versus 73%, p=0.79, figure A), and in those with advanced cancer stages (III-IV, 89% versus 85%, p=0.39, figure B). In spite of that, in those patients with early tumour stages (I-II), two years’ mortality was significantly higher in those who suffered MACE or MB than in those free of both of them (85% versus 25%, p=0.01, figure C), and this difference remained after adjusting by other independent predictors of mortality (Hazard Ratio 11.08 2.69-45.58, p=0.001).
Conclusions
In patients with AF and active lung cancer, patients with MACE and MB in follow up had similar mortality than those without them in the subgroup with advanced cancer stages. However, mortality was significantly higher in patients with these complications versus those without them in the subgroup with early cancer stages. This information could be useful for individualizing therapeutic efforts in this population.Impact of events in survival
Abstract
Background
The immune checkpoint inhibitors (ICI) have improved the prognosis of many cancers in the last years but concerning cardiovascular toxicity (CVtox) have been reported. Nowadays, ...specific surveillance protocols are lacking, and early diagnosis of toxicity may be challenging.
Purpose
To characterize the cardiovascular (CV) effects of immunotherapy and to seek for the mechanisms of CVtox of ICI in a protocolize surveillance program of cardio-oncology.
Methods
A multicentre national registry was developed by a research consortium of scientific societies of Cardiology and Oncology (SEC and SEOM) and the cardiovascular research centre (CNIC) in Spain (Figure 1). A total of 18 hospitals participate in recruiting since Q4 2021. A follow-up protocol was stablished with clinical, electrocardiographic (EKG), echocardiography, cardiac magnetic resonance (CMR) and laboratory assessment, including cardiac biomarkers, inflammatory panel and the expression of miR-721, a specific myocarditis biomarker. Toxicity management is performed at each institution following international guidelines.
Results
53 patients were currently included. Median age was 68 59, 75 years-old, 79% were male. 83% had at least 1 CV-risk factor (75% smoking history, 20% diabetes mellitus, 50% hyperlipemia, 57% hypertension, 19% chronic kidney injury) and up to34% had previous CV disease. 93% had at least one dose of COVID19 vaccine. Dyspnoea was referred by 23% of patients, 28% have abnormal EKG findings and one-third (33%) abnormal cardiac biomarkers (median Troponin I-hs 5.30 2.60, 11.00; NT-proBNP 199 68, 736). Mean LVEF (60% 56.15, 66.78) and GLS (−18 −19.75, −16) were within the normal range but 26% showed LGE at baseline. Cancer characteristics are summarized in Table 1.
Conclusion
Real-world SIR-CVT patients show a high CV risk profile and frequent pre-existing CV diseases before ICI treatment. The prospective follow-up of this cohort will help to develop personalized surveillance protocols according to baseline CVtox risk and to define different grades of cardiotoxicity.
Funding Acknowledgement
Type of funding sources: None.
Abstract
Background
Breast cancer is the most common cancer in women and the leading cause of cancer death in women. Although gestational breast cancer (GBC) accounts only for a small amount of ...diagnosis, the incidence is increasing due to delayed childbearing.
Treating GBC is a significant challenge, having to maintain a balance between effective treatment for the patient and safety for the descendants.
Anthracycline-based chemotherapy (AC) remains to be the systemic treatment of choice in many GBC patients.
Although AC in GBC appears to be safe for the descendants, data on the long-term cardiotoxic effects of AC are scarce.
Purpose
To evaluate long-term cardiotoxicity on descendants of GBC patients exposed to AC during pregnancy or breastfeeding.
Methods
We retrospectively recruited descendants of GBC patients and classified them according to AC exposure (case group and non-exposed control group). We performed a thorough echocardiographic assessment.
Results
We identified 7 GBC patients that received AC during pregnancy (n=6) or breastfeeding (n=1). All of them were diagnosed during the second or third trimester. Median cumulative anthracycline dose was 508mg/m2.
A total of 8 cases and 5 controls were recruited. Median age at echocardiographic assessment was 10 years in cases and 8 years in controls. None of them had known prior cardiac disease. Echocardiographic parameters were within normal values in both groups (Table 1).
Conclusion
A long-term echocardiographic assessment showed no abnormalities in a series of descendants of GBC exposed to AC during pregnancy or breastfeeding. This study may contribute to a better understanding of the safety for the descendants of AC during pregnancy or breastfeeding.
Funding Acknowledgement
Type of funding source: None
Abstract
Purpose
Women and men with stable coronary artery disease (sCAD) have different clinical features and management, but 1-year prognosis has been reported to be similar in large observational ...registries. The objective of the present study was to investigate the impact of female sex in the prognosis of the disease in the very long-term.
Methods
The CICCOR registry (“Chronic ischaemic heart disease in Cordoba”) is a prospective, monocentric, cohort study. From February 1, 2000 to January 31, 2004, all consecutive patients with sCAD attended at two outpatient cardiology clinics in a city of the south of Spain were included in the study and prospectively followed. Differential clinical features of women and men were described and the impact of female sex in long term prognosis was investigated.
Results
The study sample included 1268 patients, 337 women (27%) and 931 men (73% male). Women were older than men (70±9 versus 65±11 years, p<0.0005), more likely to have hypertension (72% versus 49%, p<0.0005) and diabetes (45% versus 26%), and less likely to be ex-smoker/active smoker (5%/2% versus 49%/9%, p<0.0005). They had more frequently angina in functional class ≥II (22% versus 17%, p=0.04) and atrial fibrillation (8% versus 5%, p=0.04), but had received less frequently coronary revascularization (32% versus 44%, p<0.0005). Prescription of statins (64% versus 68%, p=0.22), antiplatelets (89% versus 93%, p=0.07) and betablockers (67% versus 63%, p=0.28) at first visit was similar than men, but women received more frequently nitrates (78% versus 64%, p<0.0005), angiotensin-conversing enzyme inhibitors or receptor antagonists (56% versus 47%, p=0.004) and diuretics (41% versus 22%, p<0.0005). After up to 17 years of follow-up (median 11 years, IQR 4–15 years, with a total of 12612 patients-years of observation), probabilities of acute myocardial infarction (12% versus 14%, p=0.55) or stroke (14% versus 12%, p=0.40) at median follow up were similar for women and men. However, the risks of hospital admission for heart failure (22% versus 13%, p<0.0005) or cardiovascular death (35% versus 24%, p<0.0005) were significantly higher for women, with a non-significant trend to higher overall mortality (45% versus 39%, p=0.07). After multivariate adjustment, the risks of most events were similar for women and men (Hazard Ratios 95% confidence intervals: 0.79 0.55–1.14, p=0.21 for acute myocardial infarction; 0.89 0.61–1.29, p=0.54 for stroke; 1.13 0.82–1.57, p=0.46 for admission for heart failure; and 0.92 0.73–1.16, p=0.48 for cardiovascular death), with a non-significant trend to lower overall mortality (0.83 0.67–1.02, p=0.08).
Conclusion
Although women and men with sCAD presents a different clinical profile, and crude rates of hospital admissions for heart failure and cardiovascular death were higher in women, female sex was not an independent prognostic factor in this observational study with up to 17 years of follow-up.
Funding Acknowledgement
Type of funding source: None
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