Pub Date : 2024-10-30DOI: 10.1136/openhrt-2024-002937
Lukas Hilgendorf, Petur Petursson, Vibha Gupta, Truls Ramunddal, Erik Andersson, Peter Lundgren, Christian Dworeck, Charlotta Ljungman, Jan Boren, Aidin Rawshani, Elmir Omerovic, Gustav Smith, Zacharias Mandalenakis, Kristofer Skoglund, Araz Rawshani
Background: Elevated troponin levels are a sensitive biomarker for cardiac injury. The quick and reliable prediction of troponin elevation for patients with chest pain from readily available ECGs may pose a valuable time-saving diagnostic tool during decision-making concerning this patient population.
Methods and results: The data used included 15 856 ECGs from patients presenting to the emergency rooms with chest pain or dyspnoea at two centres in Sweden from 2015 to June 2023. All patients had high-sensitivity troponin test results within 6 hours after 12-lead ECG. Both troponin I (TnI) and TnT were used, with biomarker-specific cut-offs and sex-specific cut-offs for TnI. On this dataset, a residual convolutional neural network (ResNet) was trained 10 times, each on a unique split of the data. The final model achieved an average area under the curve for the receiver operating characteristic curve of 0.7717 (95% CI±0.0052), calibration curve analysis revealed a mean slope of 1.243 (95% CI±0.075) and intercept of -0.073 (95% CI±0.034), indicating a good correlation between prediction and ground truth. Post-classification, tuned for F1 score, accuracy was 71.43% (95% CI±1.28), with an F1 score of 0.5642 (95% CI±0.0052) and a negative predictive value of 0.8660 (95% CI±0.0048), respectively. The ResNet displayed comparable or surpassing metrics to prior presented models.
Conclusion: The model exhibited clinically meaningful performance, notably its high negative predictive accuracy. Therefore, clinical use of comparable neural networks in first-line, quick-response triage of patients with chest pain or dyspnoea appears as a valuable option in future medical practice.
{"title":"Predicting troponin biomarker elevation from electrocardiograms using a deep neural network.","authors":"Lukas Hilgendorf, Petur Petursson, Vibha Gupta, Truls Ramunddal, Erik Andersson, Peter Lundgren, Christian Dworeck, Charlotta Ljungman, Jan Boren, Aidin Rawshani, Elmir Omerovic, Gustav Smith, Zacharias Mandalenakis, Kristofer Skoglund, Araz Rawshani","doi":"10.1136/openhrt-2024-002937","DOIUrl":"10.1136/openhrt-2024-002937","url":null,"abstract":"<p><strong>Background: </strong>Elevated troponin levels are a sensitive biomarker for cardiac injury. The quick and reliable prediction of troponin elevation for patients with chest pain from readily available ECGs may pose a valuable time-saving diagnostic tool during decision-making concerning this patient population.</p><p><strong>Methods and results: </strong>The data used included 15 856 ECGs from patients presenting to the emergency rooms with chest pain or dyspnoea at two centres in Sweden from 2015 to June 2023. All patients had high-sensitivity troponin test results within 6 hours after 12-lead ECG. Both troponin I (TnI) and TnT were used, with biomarker-specific cut-offs and sex-specific cut-offs for TnI. On this dataset, a residual convolutional neural network (ResNet) was trained 10 times, each on a unique split of the data. The final model achieved an average area under the curve for the receiver operating characteristic curve of 0.7717 (95% CI±0.0052), calibration curve analysis revealed a mean slope of 1.243 (95% CI±0.075) and intercept of -0.073 (95% CI±0.034), indicating a good correlation between prediction and ground truth. Post-classification, tuned for F1 score, accuracy was 71.43% (95% CI±1.28), with an F1 score of 0.5642 (95% CI±0.0052) and a negative predictive value of 0.8660 (95% CI±0.0048), respectively. The ResNet displayed comparable or surpassing metrics to prior presented models.</p><p><strong>Conclusion: </strong>The model exhibited clinically meaningful performance, notably its high negative predictive accuracy. Therefore, clinical use of comparable neural networks in first-line, quick-response triage of patients with chest pain or dyspnoea appears as a valuable option in future medical practice.</p>","PeriodicalId":19505,"journal":{"name":"Open Heart","volume":"11 2","pages":""},"PeriodicalIF":2.8,"publicationDate":"2024-10-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11529765/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142546611","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-10-27DOI: 10.1136/openhrt-2024-002989
Joseph Okafor, Alessia Azzu, Raheel Ahmed, Shreya Ohri, Kshama Wechalekar, Athol U Wells, John Baksi, Rakesh Sharma, Dudley J Pennell, Roxy Senior, Peter Collins, Thomas Luescher, Vasilis Kouranos, Raj Khattar
Background: Echocardiography, cardiac magnetic resonance and cardiac 18fluorodeoxyglucose positron emission tomography (FDG-PET) imaging play key roles in the diagnosis and management of cardiac sarcoidosis (CS), but the relative value of each modality in predicting outcomes has yet to be determined. This study sought to determine the prognostic importance of multimodality imaging data over and above demographic characteristics and left ventricular ejection fraction (LVEF).
Methods: Consecutive patients newly diagnosed with CS were included. Parameters evaluated included echocardiographic regional wall motion abnormality (RWMA), myocardial strain, LVEF, right ventricular ejection fraction (RVEF), late gadolinium enhancement (LGE) extent, SUVmax and RV FDG uptake. The primary endpoint was a composite of all-cause mortality and serious ventricular arrhythmia.
Results: The study population consisted of 208 patients with mean age of 55±13 years and LVEF of 55±12%. During a median follow-up period of 46 (IQR: 18-55) months, 14 patients died and 28 suffered serious ventricular arrhythmias. On multivariable analysis, RWMA (HR for RWMA presence 2.55, 95% CI 1.27 to 5.28, p=0.008), LGE extent (HR per 1% increase 1.02, 95% CI 1.00 to 1.04, p=0.018), RVEF (HR per 1% decrease 0.97, 95% CI 0.94 to 0.99, p=0.008) and RV FDG uptake (HR for RV FDG presence 2.48, 95% CI 1.15 to 5.33, p=0.020) were independent predictors of the primary endpoint, while LVEF was not predictive. The risk of adverse events was significantly greater in those with LGE extent ≥15% (HR for ≥15% presence 3.96, 95% CI 2.17 to 7.23, p<0.001).
Conclusion: In our CS population, RWMA, LGE extent, RVEF and RV FDG uptake were strong independent predictors of an adverse outcome. These findings offer an important insight into the key multimodality imaging parameters that may be used in a future risk stratification model of patients with CS.
{"title":"Prognostic value of multimodality imaging in the contemporary management of cardiac sarcoidosis.","authors":"Joseph Okafor, Alessia Azzu, Raheel Ahmed, Shreya Ohri, Kshama Wechalekar, Athol U Wells, John Baksi, Rakesh Sharma, Dudley J Pennell, Roxy Senior, Peter Collins, Thomas Luescher, Vasilis Kouranos, Raj Khattar","doi":"10.1136/openhrt-2024-002989","DOIUrl":"10.1136/openhrt-2024-002989","url":null,"abstract":"<p><strong>Background: </strong>Echocardiography, cardiac magnetic resonance and cardiac <sup>18</sup>fluorodeoxyglucose positron emission tomography (FDG-PET) imaging play key roles in the diagnosis and management of cardiac sarcoidosis (CS), but the relative value of each modality in predicting outcomes has yet to be determined. This study sought to determine the prognostic importance of multimodality imaging data over and above demographic characteristics and left ventricular ejection fraction (LVEF).</p><p><strong>Methods: </strong>Consecutive patients newly diagnosed with CS were included. Parameters evaluated included echocardiographic regional wall motion abnormality (RWMA), myocardial strain, LVEF, right ventricular ejection fraction (RVEF), late gadolinium enhancement (LGE) extent, SUVmax and RV FDG uptake. The primary endpoint was a composite of all-cause mortality and serious ventricular arrhythmia.</p><p><strong>Results: </strong>The study population consisted of 208 patients with mean age of 55±13 years and LVEF of 55±12%. During a median follow-up period of 46 (IQR: 18-55) months, 14 patients died and 28 suffered serious ventricular arrhythmias. On multivariable analysis, RWMA (HR for RWMA presence 2.55, 95% CI 1.27 to 5.28, p=0.008), LGE extent (HR per 1% increase 1.02, 95% CI 1.00 to 1.04, p=0.018), RVEF (HR per 1% decrease 0.97, 95% CI 0.94 to 0.99, p=0.008) and RV FDG uptake (HR for RV FDG presence 2.48, 95% CI 1.15 to 5.33, p=0.020) were independent predictors of the primary endpoint, while LVEF was not predictive. The risk of adverse events was significantly greater in those with LGE extent ≥15% (HR for ≥15% presence 3.96, 95% CI 2.17 to 7.23, p<0.001).</p><p><strong>Conclusion: </strong>In our CS population, RWMA, LGE extent, RVEF and RV FDG uptake were strong independent predictors of an adverse outcome. These findings offer an important insight into the key multimodality imaging parameters that may be used in a future risk stratification model of patients with CS.</p>","PeriodicalId":19505,"journal":{"name":"Open Heart","volume":"11 2","pages":""},"PeriodicalIF":2.8,"publicationDate":"2024-10-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11529682/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142505234","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-10-27DOI: 10.1136/openhrt-2024-002841
Avalon Moonen, David S Celermajer, Martin Kc Ng, Geoff Strange, David Playford, Simon Stewart
Aims: We set out to explore associations between a 'mitral-specific' cardiac damage score (m-CDS) and survival outcomes in mitral regurgitation (MR) and compare the performance of the m-CDS and an 'aortic-specific' CDS (a-CDS) in patients with MR within the large National Echo Database of Australia.
Methods: Among 620 831 unique adults investigated with echocardiography, there were 17 658 individuals (3.1%) with moderate or greater functional MR (aged 76±13 years, 51% female) who met inclusion criteria. A randomly selected cohort of 5000 of these patients was used to test seven different CDS models for prediction of subsequent all-cause mortality during an average 3.8-year follow-up. The best-performing CDS model in the derivation cohort was then applied to a validation cohort of the remaining 12 658 individuals (aged 76±13 years, 51% female).
Results: The best-performing m-CDS model stratified the full cohort into Stage 0: control (1046 patients, 8%); Stage 1: left atrial damage (3416 patients, 27%); Stage 2: left ventricular damage (3352 patients, 26%); Stage 3: right ventricular damage (1551 patients, 12%) and Stage 4: pulmonary hypertension (3293 patients, 26%). Increasing m-CDS stage was consistently and incrementally associated with both all-cause and cardiovascular mortality at 1 year, 5 years and all-time and remained so after adjustment for increasing age and severity of MR, with a ~35% increase in mortality for each increase in CDS stage (p<0.001).
Conclusion: A m-CDS was robustly and incrementally associated with short-, medium- and long-term risk of all-cause and cardiovascular mortality in patients with functional MR in this large registry study.
{"title":"Mitral-specific cardiac damage score (m-CDS) predicts risk of death in functional mitral regurgitation: a study from the National Echo Database of Australia.","authors":"Avalon Moonen, David S Celermajer, Martin Kc Ng, Geoff Strange, David Playford, Simon Stewart","doi":"10.1136/openhrt-2024-002841","DOIUrl":"10.1136/openhrt-2024-002841","url":null,"abstract":"<p><strong>Aims: </strong>We set out to explore associations between a 'mitral-specific' cardiac damage score (m-CDS) and survival outcomes in mitral regurgitation (MR) and compare the performance of the m-CDS and an 'aortic-specific' CDS (a-CDS) in patients with MR within the large National Echo Database of Australia.</p><p><strong>Methods: </strong>Among 620 831 unique adults investigated with echocardiography, there were 17 658 individuals (3.1%) with moderate or greater functional MR (aged 76±13 years, 51% female) who met inclusion criteria. A randomly selected cohort of 5000 of these patients was used to test seven different CDS models for prediction of subsequent all-cause mortality during an average 3.8-year follow-up. The best-performing CDS model in the <i>derivation cohort</i> was then applied to a <i>validation cohort</i> of the remaining 12 658 individuals (aged 76±13 years, 51% female).</p><p><strong>Results: </strong>The best-performing m-CDS model stratified the full cohort into Stage 0: control (1046 patients, 8%); Stage 1: left atrial damage (3416 patients, 27%); Stage 2: left ventricular damage (3352 patients, 26%); Stage 3: right ventricular damage (1551 patients, 12%) and Stage 4: pulmonary hypertension (3293 patients, 26%). Increasing m-CDS stage was consistently and incrementally associated with both all-cause and cardiovascular mortality at 1 year, 5 years and all-time and remained so after adjustment for increasing age and severity of MR, with a ~35% increase in mortality for each increase in CDS stage (p<0.001).</p><p><strong>Conclusion: </strong>A m-CDS was robustly and incrementally associated with short-, medium- and long-term risk of all-cause and cardiovascular mortality in patients with functional MR in this large registry study.</p>","PeriodicalId":19505,"journal":{"name":"Open Heart","volume":"11 2","pages":""},"PeriodicalIF":2.8,"publicationDate":"2024-10-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11529689/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142505233","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-10-23DOI: 10.1136/openhrt-2024-002995
Dawit Zemedikun, Joseph Hung, Derrick Lopez, Matthew Knuiman, David Youens, Tom G Briffa, Frank Sanfilippo, Lee Nedkoff
Background: Since 2000, the definition of myocardial infarction (MI) has evolved with reliance on cardiac troponin (cTn) tests. The implications of this change on trends of acute coronary syndrome (ACS) subtypes obtained from routinely collected hospital morbidity data are unclear. Using person-linked hospitalisation data, we compared International Classification of Diseases (ICD)-coded data with biomarker-classified admission rates for ST-segment elevation MI (STEMI), non-STEMI (NSTEMI) and unstable angina (UA) in Western Australia (WA).
Methods: We used linked hospitalisation data from all WA tertiary hospitals to identify patients with a principal diagnosis of STEMI, NSTEMI or UA between 2002 and 2016. Linked biomarker results were classified as 'diagnostic' for MI according to established criteria. We calculated age-standardised and sex-standardised rates (ASSRs) for ICD-coded versus biomarker-classified admissions by ACS subtypes and estimated annual change in admissions using Poisson regression adjusting for age and sex.
Results: There were 37 272 ACS admissions in 30 683 patients (64.2% male), and 96% of cases had linked biomarker data, predominantly conventional cTn at the start and high-sensitive cTn from late 2013. Despite lower ASSRs, trends in MI classified with a diagnostic biomarker were concordant with ICD-coded admissions rates for both STEMI and NSTEMI. Between 2002 and 2010, STEMI rates declined by 4.1% (95% CI 5.0%, 3.1%) and 3.4% (95% CI 4.6%, 2.3%) in ICD-coded and biomarker-classified admissions, respectively, and both plateaued thereafter. For NSTEMI between 2002 and 2010, the ICD-coded and biomarker-classified rates increased 8.0% per year (95% CI 7.2%, 8.9%) and 8.0% (95% CI 7.0%, 9.0%), respectively, and both subsequently declined. For UA, both ICD-coded and biomarker-classified UA admission rates declined in a steady and concordant manner between 2002 and 2016.
Conclusions: The present study supports the validity of using administrative data to monitor population trends in ACS subtypes as they appear to generally reflect the redefinition of MI in the troponin era.
{"title":"Temporal trends in concordance between ICD-coded and cardiac biomarker-classified hospitalisation rates for acute coronary syndromes: a linked hospital and biomarker data study.","authors":"Dawit Zemedikun, Joseph Hung, Derrick Lopez, Matthew Knuiman, David Youens, Tom G Briffa, Frank Sanfilippo, Lee Nedkoff","doi":"10.1136/openhrt-2024-002995","DOIUrl":"10.1136/openhrt-2024-002995","url":null,"abstract":"<p><strong>Background: </strong>Since 2000, the definition of myocardial infarction (MI) has evolved with reliance on cardiac troponin (cTn) tests. The implications of this change on trends of acute coronary syndrome (ACS) subtypes obtained from routinely collected hospital morbidity data are unclear. Using person-linked hospitalisation data, we compared International Classification of Diseases (ICD)-coded data with biomarker-classified admission rates for ST-segment elevation MI (STEMI), non-STEMI (NSTEMI) and unstable angina (UA) in Western Australia (WA).</p><p><strong>Methods: </strong>We used linked hospitalisation data from all WA tertiary hospitals to identify patients with a principal diagnosis of STEMI, NSTEMI or UA between 2002 and 2016. Linked biomarker results were classified as 'diagnostic' for MI according to established criteria. We calculated age-standardised and sex-standardised rates (ASSRs) for ICD-coded versus biomarker-classified admissions by ACS subtypes and estimated annual change in admissions using Poisson regression adjusting for age and sex.</p><p><strong>Results: </strong>There were 37 272 ACS admissions in 30 683 patients (64.2% male), and 96% of cases had linked biomarker data, predominantly conventional cTn at the start and high-sensitive cTn from late 2013. Despite lower ASSRs, trends in MI classified with a diagnostic biomarker were concordant with ICD-coded admissions rates for both STEMI and NSTEMI. Between 2002 and 2010, STEMI rates declined by 4.1% (95% CI 5.0%, 3.1%) and 3.4% (95% CI 4.6%, 2.3%) in ICD-coded and biomarker-classified admissions, respectively, and both plateaued thereafter. For NSTEMI between 2002 and 2010, the ICD-coded and biomarker-classified rates increased 8.0% per year (95% CI 7.2%, 8.9%) and 8.0% (95% CI 7.0%, 9.0%), respectively, and both subsequently declined. For UA, both ICD-coded and biomarker-classified UA admission rates declined in a steady and concordant manner between 2002 and 2016.</p><p><strong>Conclusions: </strong>The present study supports the validity of using administrative data to monitor population trends in ACS subtypes as they appear to generally reflect the redefinition of MI in the troponin era.</p>","PeriodicalId":19505,"journal":{"name":"Open Heart","volume":"11 2","pages":""},"PeriodicalIF":2.8,"publicationDate":"2024-10-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11499754/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142505235","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Background: Patients with heart failure exhibiting low systolic blood pressure (SBP) have a poor prognosis. Sacubitril/valsartan reduces cardiovascular events; however, its use in patients with low SBP has not been fully examined. Therefore, in this study, we aimed to investigate the association between baseline SBP and adverse events (AEs) in patients starting sacubitril/valsartan therapy using data from a real-world registry in Japan.
Methods: We analysed data from a multicentre retrospective study, including patients who initiated sacubitril/valsartan between August 2020 and August 2021. The patients were categorised into five groups based on their baseline SBP (<100, 100-109, 110-119, 120-129 and ≥130 mm Hg). The composite of AEs occurring within 3 months according to baseline SBP and the patient characteristics associated with AEs in a baseline SBP <110 mm Hg were analysed.
Results: Among the 964 patients newly prescribed sacubitril/valsartan, the median (IQR) age was 73 (61-80) years, and 388 (40.2%) patients had a baseline SBP <110 mm Hg. AEs occurred in 24% (n=232) of patients. The adjusted ORs for all AEs were 1.91 (95% CI (CI) 1.13-3.23; p=0.02) for the SBP <100 mm Hg group and 3.33 (95% CI 1.98 to 5.59; p<0.001) for the SBP 100-109 mm Hg group, compared with the SBP 110-119 mm Hg group. In patients with a baseline SBP <110 mm Hg, factors associated with an increased risk of AEs included a higher New York Heart Association class (II, III or IV) and a lower estimated glomerular filtration rate <30 mL/min/1.73 m2.
Conclusions: Caution is needed when initiating sacubitril/valsartan in patients with lower baseline SBP. The severity of heart failure and kidney function may be useful for risk stratification in these high-risk patients.
{"title":"Risk stratification by renal function and NYHA class in patients with hypotension initiated on sacubitril/valsartan: a retrospective cohort study from 17 centres in Japan.","authors":"Koshiro Kanaoka, Takahito Nasu, Atsushi Kikuchi, Takeshi Ijichi, Tatsuhiro Shibata, Keisuke Kida, Nobuyuki Kagiyama, Wataru Fujimoto, Syunsuke Ishii, Yoshitaka Iwanaga, Yoshihiro Miyamoto, Shingo Matsumoto","doi":"10.1136/openhrt-2024-002764","DOIUrl":"10.1136/openhrt-2024-002764","url":null,"abstract":"<p><strong>Background: </strong>Patients with heart failure exhibiting low systolic blood pressure (SBP) have a poor prognosis. Sacubitril/valsartan reduces cardiovascular events; however, its use in patients with low SBP has not been fully examined. Therefore, in this study, we aimed to investigate the association between baseline SBP and adverse events (AEs) in patients starting sacubitril/valsartan therapy using data from a real-world registry in Japan.</p><p><strong>Methods: </strong>We analysed data from a multicentre retrospective study, including patients who initiated sacubitril/valsartan between August 2020 and August 2021. The patients were categorised into five groups based on their baseline SBP (<100, 100-109, 110-119, 120-129 and ≥130 mm Hg). The composite of AEs occurring within 3 months according to baseline SBP and the patient characteristics associated with AEs in a baseline SBP <110 mm Hg were analysed.</p><p><strong>Results: </strong>Among the 964 patients newly prescribed sacubitril/valsartan, the median (IQR) age was 73 (61-80) years, and 388 (40.2%) patients had a baseline SBP <110 mm Hg. AEs occurred in 24% (n=232) of patients. The adjusted ORs for all AEs were 1.91 (95% CI (CI) 1.13-3.23; p=0.02) for the SBP <100 mm Hg group and 3.33 (95% CI 1.98 to 5.59; p<0.001) for the SBP 100-109 mm Hg group, compared with the SBP 110-119 mm Hg group. In patients with a baseline SBP <110 mm Hg, factors associated with an increased risk of AEs included a higher New York Heart Association class (II, III or IV) and a lower estimated glomerular filtration rate <30 mL/min/1.73 m<sup>2</sup>.</p><p><strong>Conclusions: </strong>Caution is needed when initiating sacubitril/valsartan in patients with lower baseline SBP. The severity of heart failure and kidney function may be useful for risk stratification in these high-risk patients.</p>","PeriodicalId":19505,"journal":{"name":"Open Heart","volume":"11 2","pages":""},"PeriodicalIF":2.8,"publicationDate":"2024-10-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11499766/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142471526","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-10-17DOI: 10.1136/openhrt-2024-002912
Marie-Ange Fleury, Lionel Tastet, Jérémy Bernard, Mylène Shen, Romain Capoulade, Kathia Abdoun, Élisabeth Bédard, Marie Arsenault, Philippe Chetaille, Jonathan Beaudoin, Mathieu Bernier, Erwan Salaun, Nancy Côté, Philippe Pibarot, Sébastien Hecht
Background: Bicuspid aortic valve (BAV) is often associated with a concomitant aortopathy. However, few studies have evaluated the effect of the aortic valve (AV) phenotype on the rate of dilation of the aorta. This study aimed to compare the progression rate of aorta dimensions according to AV phenotype (BAV vs tricuspid AV (TAV)), fusion type and sex in patients with aortic stenosis (AS).
Methods: 310 patients with AS (224 TAV and 86 BAV) recruited in the Metabolic Determinants of the Progression of Aortic Stenosis study (PROGRESSA, NCT01679431) were included in this analysis. Doppler echocardiography was performed annually to assess AS severity and measure ascending aorta (AA) dimensions. Baseline and last follow-up visit measurements were used to assess the annualised change.
Results: Median AA annualised change was larger in BAV versus TAV (0.33±0.65 mm/year vs 0.21±0.56 mm/year, p=0.04). In the whole cohort, BAV phenotype and higher low-density lipoprotein (LDL) levels were significantly associated with fast progression of AA dilation in univariate analysis (OR 1.80, 95% CI 1.08 to 2.98, p=0.02; 1.37, 95% CI 1.04 to 1.80, p=0.03, respectively). AA dilation rate did not vary according to the BAV subtype (p=0.142). Predictors of AA progression rate were different between valve phenotypes, with higher apolipoprotein B/apolipoprotein A-I ratio, higher baseline peak aortic jet velocity (Vpeak) and smaller baseline AA diameter in the TAV cohort (all p<0.05) versus absence of hypertension, higher LDL levels and smaller baseline AA diameter in the BAV cohort (all p<0.02). In men, higher baseline Vpeak and smaller baseline AA (p<0.001) were independently associated with increased annualised AA dilation, while in women, higher LDL levels (p=0.026) were independently associated with faster AA dilation.
Conclusion: This study suggests that BAV is associated with faster dilation of the AA. Predictors of AA dilation are different between valve phenotype and sex, with higher LDL levels being associated with faster AA dilation in BAV.
背景:主动脉瓣二尖瓣(BAV)通常伴有主动脉病变。然而,很少有研究评估主动脉瓣(AV)表型对主动脉扩张速度的影响。本研究旨在根据主动脉瓣表型(BAV 与三尖瓣 AV (TAV))、融合类型和性别,比较主动脉狭窄(AS)患者主动脉尺寸的进展率。每年进行一次多普勒超声心动图检查,以评估主动脉瓣狭窄的严重程度并测量升主动脉(AA)的尺寸。基线测量值和最后一次随访测量值用于评估年化变化:结果:BAV与TAV相比,中位AA年化变化更大(0.33±0.65毫米/年 vs 0.21±0.56毫米/年,P=0.04)。在整个队列中,在单变量分析中,BAV 表型和较高的低密度脂蛋白(LDL)水平与 AA 扩张的快速进展显著相关(OR 分别为 1.80,95% CI 1.08 至 2.98,p=0.02;1.37,95% CI 1.04 至 1.80,p=0.03)。AA扩张率与BAV亚型无关(P=0.142)。不同瓣膜表型的 AA 进展率预测因素不同,TAV 队列的载脂蛋白 B/载脂蛋白 A-I 比率更高、基线主动脉喷射速度峰值(Vpeak)更高、基线 AA 直径更小(所有峰值和基线 AA 更小)(pConclusion):这项研究表明,BAV 与 AA 的快速扩张有关。AA扩张的预测因素因瓣膜表型和性别而异,低密度脂蛋白水平越高,BAV的AA扩张越快。
{"title":"Effect of aortic valve phenotype and sex on aorta dilation in patients with aortic stenosis.","authors":"Marie-Ange Fleury, Lionel Tastet, Jérémy Bernard, Mylène Shen, Romain Capoulade, Kathia Abdoun, Élisabeth Bédard, Marie Arsenault, Philippe Chetaille, Jonathan Beaudoin, Mathieu Bernier, Erwan Salaun, Nancy Côté, Philippe Pibarot, Sébastien Hecht","doi":"10.1136/openhrt-2024-002912","DOIUrl":"https://doi.org/10.1136/openhrt-2024-002912","url":null,"abstract":"<p><strong>Background: </strong>Bicuspid aortic valve (BAV) is often associated with a concomitant aortopathy. However, few studies have evaluated the effect of the aortic valve (AV) phenotype on the rate of dilation of the aorta. This study aimed to compare the progression rate of aorta dimensions according to AV phenotype (BAV vs tricuspid AV (TAV)), fusion type and sex in patients with aortic stenosis (AS).</p><p><strong>Methods: </strong>310 patients with AS (224 TAV and 86 BAV) recruited in the Metabolic Determinants of the Progression of Aortic Stenosis study (PROGRESSA, NCT01679431) were included in this analysis. Doppler echocardiography was performed annually to assess AS severity and measure ascending aorta (AA) dimensions. Baseline and last follow-up visit measurements were used to assess the annualised change.</p><p><strong>Results: </strong>Median AA annualised change was larger in BAV versus TAV (0.33±0.65 mm/year vs 0.21±0.56 mm/year, p=0.04). In the whole cohort, BAV phenotype and higher low-density lipoprotein (LDL) levels were significantly associated with fast progression of AA dilation in univariate analysis (OR 1.80, 95% CI 1.08 to 2.98, p=0.02; 1.37, 95% CI 1.04 to 1.80, p=0.03, respectively). AA dilation rate did not vary according to the BAV subtype (p=0.142). Predictors of AA progression rate were different between valve phenotypes, with higher apolipoprotein B/apolipoprotein A-I ratio, higher baseline peak aortic jet velocity (V<sub>peak</sub>) and smaller baseline AA diameter in the TAV cohort (all p<0.05) versus absence of hypertension, higher LDL levels and smaller baseline AA diameter in the BAV cohort (all p<0.02). In men, higher baseline V<sub>peak</sub> and smaller baseline AA (p<0.001) were independently associated with increased annualised AA dilation, while in women, higher LDL levels (p=0.026) were independently associated with faster AA dilation.</p><p><strong>Conclusion: </strong>This study suggests that BAV is associated with faster dilation of the AA. Predictors of AA dilation are different between valve phenotype and sex, with higher LDL levels being associated with faster AA dilation in BAV.</p>","PeriodicalId":19505,"journal":{"name":"Open Heart","volume":"11 2","pages":""},"PeriodicalIF":2.8,"publicationDate":"2024-10-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11487820/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142471522","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-10-17DOI: 10.1136/openhrt-2024-002817
Aleksi J Leikas, Juha E K Hartikainen, Jens Kastrup, Anthony Mathur, Mariann Gyöngyösi, Francisco Fernández-Avilés, Ricardo Sanz-Ruiz, Wojtek Wojakowski, Adrian Gwizdała, Riho Luite, Marko Nikkinen, Abbas A Qayyum, Mandana Haack-Sørensen, Matthew Kelham, Daniel A Jones, Kevin Hamzaraj, Andreas Spannbauer, Maria E Fernández-Santos, Marek Jędrzejek, Agnieszka Skoczyńska, Niklas Vartiainen, Juhani Knuuti, Antti Saraste, Seppo Ylä-Herttuala
Background: Despite tremendous therapeutic advancements, a significant proportion of coronary artery disease patients suffer from refractory angina pectoris, that is, quality-of-life-compromising angina that is non-manageable with established pharmacological and interventional treatment options. Adenoviral vascular endothelial growth factor-DΔNΔC (AdVEGF-D)-encoding gene therapy (GT) holds promise for the treatment of refractory angina.
Methods: ReGenHeart is an investigator-initiated, multicentre, randomised, placebo-controlled and double-blinded phase 2 clinical trial that aims to study the safety and efficacy of intramyocardially administered angiogenic AdVEGF-D GT for refractory angina. Patients will be randomised in a 2:1 ratio and blocks of six to receive either AdVEGF-D or placebo. Primary endpoints are improvements in functional capacity assessed with the 6 min walking test and angina symptoms with Canadian Cardiovascular Society class after 6 month follow-up. Secondary endpoints are improvements in myocardial perfusion assessed with either positron emission tomography or single-photon emission CT after 6 month follow-up and functional capacity and angina symptoms after 12 months. In addition, changes in the quality of life, the use of angina medication and the incidence of major adverse cardiac and cerebrovascular events will be evaluated.
Conclusions: The phase 2 ReGenHeart trial will provide knowledge of the safety and efficacy of AdVEGF-D GT to ameliorate symptoms in refractory angina patients, extending and further testing positive results from the preceding phase 1/2a trial.
{"title":"Clinical development and proof of principle testing of new regenerative vascular endothelial growth factor-D therapy for refractory angina: rationale and design of the phase 2 ReGenHeart trial.","authors":"Aleksi J Leikas, Juha E K Hartikainen, Jens Kastrup, Anthony Mathur, Mariann Gyöngyösi, Francisco Fernández-Avilés, Ricardo Sanz-Ruiz, Wojtek Wojakowski, Adrian Gwizdała, Riho Luite, Marko Nikkinen, Abbas A Qayyum, Mandana Haack-Sørensen, Matthew Kelham, Daniel A Jones, Kevin Hamzaraj, Andreas Spannbauer, Maria E Fernández-Santos, Marek Jędrzejek, Agnieszka Skoczyńska, Niklas Vartiainen, Juhani Knuuti, Antti Saraste, Seppo Ylä-Herttuala","doi":"10.1136/openhrt-2024-002817","DOIUrl":"https://doi.org/10.1136/openhrt-2024-002817","url":null,"abstract":"<p><strong>Background: </strong>Despite tremendous therapeutic advancements, a significant proportion of coronary artery disease patients suffer from refractory angina pectoris, that is, quality-of-life-compromising angina that is non-manageable with established pharmacological and interventional treatment options. Adenoviral vascular endothelial growth factor-D<sup>ΔNΔC</sup> (AdVEGF-D)-encoding gene therapy (GT) holds promise for the treatment of refractory angina.</p><p><strong>Methods: </strong>ReGenHeart is an investigator-initiated, multicentre, randomised, placebo-controlled and double-blinded phase 2 clinical trial that aims to study the safety and efficacy of intramyocardially administered angiogenic AdVEGF-D GT for refractory angina. Patients will be randomised in a 2:1 ratio and blocks of six to receive either AdVEGF-D or placebo. Primary endpoints are improvements in functional capacity assessed with the 6 min walking test and angina symptoms with Canadian Cardiovascular Society class after 6 month follow-up. Secondary endpoints are improvements in myocardial perfusion assessed with either positron emission tomography or single-photon emission CT after 6 month follow-up and functional capacity and angina symptoms after 12 months. In addition, changes in the quality of life, the use of angina medication and the incidence of major adverse cardiac and cerebrovascular events will be evaluated.</p><p><strong>Conclusions: </strong>The phase 2 ReGenHeart trial will provide knowledge of the safety and efficacy of AdVEGF-D GT to ameliorate symptoms in refractory angina patients, extending and further testing positive results from the preceding phase 1/2a trial.</p>","PeriodicalId":19505,"journal":{"name":"Open Heart","volume":"11 2","pages":""},"PeriodicalIF":2.8,"publicationDate":"2024-10-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11487854/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142471521","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-10-16DOI: 10.1136/openhrt-2024-002904
Peng-Cheng Yao, Mo-Han Li, Mu Chen, Qian-Ji Che, Yu-Dong Fei, Guan-Lin Li, Jian Sun, Qun-Shan Wang, Yong-Bo Wu, Mei Yang, Ming-Zhe Zhao, Yu-Li Yang, Zhong-Xi Cai, Li Luo, Hong Wu, Yi-Gang Li
Background: The circadian variation pattern of sudden cardiac arrest (SCA) occurred in Chinese community including both community healthcare centres and primary hospitals remains unknown. This study analysed the circadian variation of SCA in the Chinese community.
Methods: Data between 2018 and 2022 from the remote ECG diagnosis system of Xinhua Hospital affiliated to Shanghai Jiao Tong University School of Medicine were analysed to examine the circadian rhythm of SCA, stratified by initial shockable (ventricular tachycardia or ventricular fibrillation) versus non-shockable (asystole or pulseless electrical activity) rhythm.
Results: Among 10 210 cases of SCA, major cases (8736, 85.6%) were non-shockable and 1474 (14.4%) cases were shockable. The circadian rhythm of SCA was as follows: peak time was from 08:00 to 11:59 (30.1%), while deep valley was from 00:00 to 03:59 (7.5%). The proportions of events by non-shockable and shockable events were similar and both reached their peak from 08:00 to 11:59, with a percentage of 29.0% and 36.4%, respectively. Multivariable analysis showed that the relative risk of shockable compared with non-shockable arrests was lower between 00:00 and 03:59 (adjusted OR (aOR): 0.72, 95% CI: 0.54 to 0.97, p=0.028) and 04:00 to 07:59 (aOR: 0.60, 95% CI: 0.46 to 0.79, p<0.001), but higher between 08:00 and 11:59 (aOR: 1.34, 95% CI: 1.09 to 1.64, p=0.005).
Conclusions: In Chinese community, there is a distinct circadian rhythm of SCA, regardless of initial rhythms. Our findings may be helpful in decision-making, in that more attention and manpower should be placed on the morning hours of first-aid and resuscitation management in Chinese community.
{"title":"Circadian variation pattern of sudden cardiac arrest occurred in Chinese community.","authors":"Peng-Cheng Yao, Mo-Han Li, Mu Chen, Qian-Ji Che, Yu-Dong Fei, Guan-Lin Li, Jian Sun, Qun-Shan Wang, Yong-Bo Wu, Mei Yang, Ming-Zhe Zhao, Yu-Li Yang, Zhong-Xi Cai, Li Luo, Hong Wu, Yi-Gang Li","doi":"10.1136/openhrt-2024-002904","DOIUrl":"10.1136/openhrt-2024-002904","url":null,"abstract":"<p><strong>Background: </strong>The circadian variation pattern of sudden cardiac arrest (SCA) occurred in Chinese community including both community healthcare centres and primary hospitals remains unknown. This study analysed the circadian variation of SCA in the Chinese community.</p><p><strong>Methods: </strong>Data between 2018 and 2022 from the remote ECG diagnosis system of Xinhua Hospital affiliated to Shanghai Jiao Tong University School of Medicine were analysed to examine the circadian rhythm of SCA, stratified by initial shockable (ventricular tachycardia or ventricular fibrillation) versus non-shockable (asystole or pulseless electrical activity) rhythm.</p><p><strong>Results: </strong>Among 10 210 cases of SCA, major cases (8736, 85.6%) were non-shockable and 1474 (14.4%) cases were shockable. The circadian rhythm of SCA was as follows: peak time was from 08:00 to 11:59 (30.1%), while deep valley was from 00:00 to 03:59 (7.5%). The proportions of events by non-shockable and shockable events were similar and both reached their peak from 08:00 to 11:59, with a percentage of 29.0% and 36.4%, respectively. Multivariable analysis showed that the relative risk of shockable compared with non-shockable arrests was lower between 00:00 and 03:59 (adjusted OR (aOR): 0.72, 95% CI: 0.54 to 0.97, p=0.028) and 04:00 to 07:59 (aOR: 0.60, 95% CI: 0.46 to 0.79, p<0.001), but higher between 08:00 and 11:59 (aOR: 1.34, 95% CI: 1.09 to 1.64, p=0.005).</p><p><strong>Conclusions: </strong>In Chinese community, there is a distinct circadian rhythm of SCA, regardless of initial rhythms. Our findings may be helpful in decision-making, in that more attention and manpower should be placed on the morning hours of first-aid and resuscitation management in Chinese community.</p>","PeriodicalId":19505,"journal":{"name":"Open Heart","volume":"11 2","pages":""},"PeriodicalIF":2.8,"publicationDate":"2024-10-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11487843/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142471520","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-10-15DOI: 10.1136/openhrt-2024-002704
Kornelia Kotseva, Catriona Jennings, Paul Bassett, Agnieszka Adamska, Richard Hobbs, David Wood
Background: Implementation of the cardiovascular disease (CVD) prevention guidelines in the UK has been repeatedly evaluated under the auspices of the British Cardiovascular Society in three Action on Secondary and Primary Prevention by Intervention to Reduce Events (ASPIRE) surveys in 1994-1995, 2008-2010 and 2017-2019. The primary care arm of ASPIRE-2-PREVENT (A-3-P) was conducted to evaluate lifestyle and medical risk factor management in people at high risk of atherosclerotic CVD in everyday clinical practice.
Methods: A-3-P was a cross-sectional survey in 27 general practices and health centres across 5 English National Health Service regions. Patients with no history of atherosclerotic CVD started on blood pressure and/or lipid and/or glucose lowering treatments were identified retrospectively and interviewed at least 6 months after the initiation of medication.
Results: 557 patients attended the interview and examination (45.8% women; mean age 61.7±10.8 years). The risk factor control was poor: 9.3% of patients were smokers, 38.1% obese (body mass index≥30 kg/m2) and 53.5% centrally obese (waist circumference≥88 cm for women, ≥102 cm for men). Only 37.8% of patients on blood pressure-lowering therapies achieved the target of<140/90 mm Hg. Among treated dyslipidaemic patients, 59.5% reached the low-density lipoprotein cholesterol target of <2.6 mmol/L. 62% of patients with self-reported diabetes mellitus attained the glycated haemoglobin target of <7.0%.
Conclusion: The results of A-3-P survey show that large proportions of people at high CVD risk have poor control of lifestiles and medical risk factors. There is considerable potential to raise the standards of preventive cardiology care by providing comprehensive, multidisciplinary prevention programmes addressing all aspects of risk factor management to reduce the total risk of future CVD.
{"title":"Challenge of cardiovascular prevention in primary care: achievement of lifestyle, blood pressure, lipids and diabetes targets for primary prevention in England - results from ASPIRE-3-PREVENT cross-sectional survey.","authors":"Kornelia Kotseva, Catriona Jennings, Paul Bassett, Agnieszka Adamska, Richard Hobbs, David Wood","doi":"10.1136/openhrt-2024-002704","DOIUrl":"10.1136/openhrt-2024-002704","url":null,"abstract":"<p><strong>Background: </strong>Implementation of the cardiovascular disease (CVD) prevention guidelines in the UK has been repeatedly evaluated under the auspices of the British Cardiovascular Society in three Action on Secondary and Primary Prevention by Intervention to Reduce Events (ASPIRE) surveys in 1994-1995, 2008-2010 and 2017-2019. The primary care arm of ASPIRE-2-PREVENT (A-3-P) was conducted to evaluate lifestyle and medical risk factor management in people at high risk of atherosclerotic CVD in everyday clinical practice.</p><p><strong>Methods: </strong>A-3-P was a cross-sectional survey in 27 general practices and health centres across 5 English National Health Service regions. Patients with no history of atherosclerotic CVD started on blood pressure and/or lipid and/or glucose lowering treatments were identified retrospectively and interviewed at least 6 months after the initiation of medication.</p><p><strong>Results: </strong>557 patients attended the interview and examination (45.8% women; mean age 61.7±10.8 years). The risk factor control was poor: 9.3% of patients were smokers, 38.1% obese (body mass index≥30 kg/m<sup>2</sup>) and 53.5% centrally obese (waist circumference≥88 cm for women, ≥102 cm for men). Only 37.8% of patients on blood pressure-lowering therapies achieved the target of<140/90 mm Hg. Among treated dyslipidaemic patients, 59.5% reached the low-density lipoprotein cholesterol target of <2.6 mmol/L. 62% of patients with self-reported diabetes mellitus attained the glycated haemoglobin target of <7.0%.</p><p><strong>Conclusion: </strong>The results of A-3-P survey show that large proportions of people at high CVD risk have poor control of lifestiles and medical risk factors. There is considerable potential to raise the standards of preventive cardiology care by providing comprehensive, multidisciplinary prevention programmes addressing all aspects of risk factor management to reduce the total risk of future CVD.</p>","PeriodicalId":19505,"journal":{"name":"Open Heart","volume":"11 2","pages":""},"PeriodicalIF":2.8,"publicationDate":"2024-10-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11481111/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142471519","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-10-15DOI: 10.1136/openhrt-2024-002870
Adrián Jerónimo, Luis Nombela-Franco, Patricia Simal, Xavier Freixa, Enrico Cerrato, Ignacio Cruz-Gonzalez, Guillermo Dueñas, Gabriela Veiga-Fernandez, Luis Renier Goncalves-Ramirez, Sergio Garcia-Blas, Ana Fernández-Revuelta, Pedro Cepas-Guillén, Francesco Tomassini, Sergio Lopez-Tejero, Rafael Gonzalez-Manzanares, Jose M De la Torre Hernandez, Armando Perez de Prado, Ernesto Valero, Rami Gabani, Alejandro Travieso, Jose Alberto de Agustín, Gabriela Tirado, Pilar Jimenez-Quevedo, Pablo Salinas
Background: The benefit of patent foramen ovale closure (PFOC) ≤9 months after a cryptogenic stroke has been demonstrated in several randomised clinical trials. There is, however, insufficient data to support PFOC in non-recent cryptogenic strokes.
Aims: The objective of the study was to evaluate the effectiveness of PFOC in relation to the time since the patient's most recent cryptogenic cerebrovascular event (CVE) or systemic embolism (SE).
Methods: We conducted a multicentre, retrospective cohort study with international participation, to assess the results of an early closure (EC, <9 months) for secondary prevention versus a delayed closure (DC, ≥9 months). Recurrence of CVE/SE following PFOC was evaluated as the primary endpoint.
Results: 496 patients were included (65% in the EC and 35% in the DC group). With the exception of a larger defect size in the DC group (tunnel width 6 (4-14) vs 12 (6-16) mm, p=0.005), similar clinical and echocardiographic baseline features were observed between the groups. No differences were observed regarding the type of devices used for PFOC, procedural success rate (99.4 in EC vs 98.8% DC group) and periprocedural complications (2.1% vs 0.8%). Median follow-up was 2.0 (1.2-4.2) years in the whole study population. Recurrence of CVE/SE (3.9% vs 2.6%, p=0.443), death (1.4% vs 1.0%, p=0.697), residual shunt 12 months after PFOC, or antithrombotic treatment strategy were comparable in both groups during follow-up. A subanalysis comparing very delayed PFOC (≥24 months) also showed no differences in recurrence (4.2% in the <24-month vs 3.4% in the ≥24-month group, p=0.770).
Conclusion: Patients undergoing PFOC before and after 9 months after the index event had a comparable recurrence rate of CVE/SE. These findings suggest that PFOC might be recommended in cryptogenic CVE/SE which are more remote than 9 months.
背景:多项随机临床试验证实,隐源性脑卒中发生后≤9 个月时进行卵圆孔闭合术(PFOC)是有益的。目的:本研究旨在评估 PFOC 的有效性与患者最近一次隐源性脑血管事件(CVE)或全身性栓塞(SE)发生时间的关系:我们开展了一项有国际参与的多中心回顾性队列研究,以评估早期闭合(EC)的效果:研究共纳入了 496 名患者(65% 属于 EC 组,35% 属于 DC 组)。除直流组缺损面积较大(隧道宽度 6 (4-14) mm vs 12 (6-16) mm,P=0.005)外,两组患者的临床和超声心动图基线特征相似。PFOC所用设备的类型、手术成功率(EC组99.4% vs DC组98.8%)和围手术期并发症(2.1% vs 0.8%)均无差异。整个研究人群的中位随访时间为 2.0(1.2-4.2)年。两组随访期间的 CVE/SE 复发率(3.9% vs 2.6%,P=0.443)、死亡率(1.4% vs 1.0%,P=0.697)、PFOC 12 个月后的残余分流率或抗血栓治疗策略相当。一项比较极度延迟的 PFOC(≥24 个月)的子分析也显示,两组的复发率没有差异(结论:PFOC 术后复发率为 4.2%):在指数事件发生后 9 个月之前和之后接受 PFOC 的患者的 CVE/SE 复发率相当。这些研究结果表明,对于时间超过9个月的隐源性CVE/SE,可推荐使用PFOC。
{"title":"Influence of procedural timing on the preventive yield of percutaneous patent foramen ovale closure.","authors":"Adrián Jerónimo, Luis Nombela-Franco, Patricia Simal, Xavier Freixa, Enrico Cerrato, Ignacio Cruz-Gonzalez, Guillermo Dueñas, Gabriela Veiga-Fernandez, Luis Renier Goncalves-Ramirez, Sergio Garcia-Blas, Ana Fernández-Revuelta, Pedro Cepas-Guillén, Francesco Tomassini, Sergio Lopez-Tejero, Rafael Gonzalez-Manzanares, Jose M De la Torre Hernandez, Armando Perez de Prado, Ernesto Valero, Rami Gabani, Alejandro Travieso, Jose Alberto de Agustín, Gabriela Tirado, Pilar Jimenez-Quevedo, Pablo Salinas","doi":"10.1136/openhrt-2024-002870","DOIUrl":"10.1136/openhrt-2024-002870","url":null,"abstract":"<p><strong>Background: </strong>The benefit of patent foramen ovale closure (PFOC) ≤9 months after a cryptogenic stroke has been demonstrated in several randomised clinical trials. There is, however, insufficient data to support PFOC in non-recent cryptogenic strokes.</p><p><strong>Aims: </strong>The objective of the study was to evaluate the effectiveness of PFOC in relation to the time since the patient's most recent cryptogenic cerebrovascular event (CVE) or systemic embolism (SE).</p><p><strong>Methods: </strong>We conducted a multicentre, retrospective cohort study with international participation, to assess the results of an early closure (EC, <9 months) for secondary prevention versus a delayed closure (DC, ≥9 months). Recurrence of CVE/SE following PFOC was evaluated as the primary endpoint.</p><p><strong>Results: </strong>496 patients were included (65% in the EC and 35% in the DC group). With the exception of a larger defect size in the DC group (tunnel width 6 (4-14) vs 12 (6-16) mm, p=0.005), similar clinical and echocardiographic baseline features were observed between the groups. No differences were observed regarding the type of devices used for PFOC, procedural success rate (99.4 in EC vs 98.8% DC group) and periprocedural complications (2.1% vs 0.8%). Median follow-up was 2.0 (1.2-4.2) years in the whole study population. Recurrence of CVE/SE (3.9% vs 2.6%, p=0.443), death (1.4% vs 1.0%, p=0.697), residual shunt 12 months after PFOC, or antithrombotic treatment strategy were comparable in both groups during follow-up. A subanalysis comparing very delayed PFOC (≥24 months) also showed no differences in recurrence (4.2% in the <24-month vs 3.4% in the ≥24-month group, p=0.770).</p><p><strong>Conclusion: </strong>Patients undergoing PFOC before and after 9 months after the index event had a comparable recurrence rate of CVE/SE. These findings suggest that PFOC might be recommended in cryptogenic CVE/SE which are more remote than 9 months.</p>","PeriodicalId":19505,"journal":{"name":"Open Heart","volume":"11 2","pages":""},"PeriodicalIF":2.8,"publicationDate":"2024-10-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11481237/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142471524","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}