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Real-World Assessment of Mavacamten's Impact on Left Ventricular Systolic and Diastolic Functions in Obstructive Hypertrophic Cardiomyopathy: A 1-Year Single-Center Observational Study
IF 2.3 3区 医学 Q2 CARDIAC & CARDIOVASCULAR SYSTEMS Pub Date : 2025-01-31 DOI: 10.1016/j.amjcard.2025.01.032
Zaid Abood MD , M. Fuad Jan MBBS (Hons), MD , Muddasir Ashraf MD , Prabhjot Hundal MD , Lauren Howard BS, RDCS (AE, PE), RVT , Heather Sanders NP , Amanda Misicka RN , Asad Ghafoor MD , Arshad Jahangir MD , Patrycja Galazka MD , A. Jamil Tajik MD
Real-world data on the effects of mavacamten on diastology and global longitudinal strain (GLS) in symptomatic patients with obstructive hypertrophic cardiomyopathy (oHCM) are limited. We share our experience with mavacamten over a 24-week period at an HCM Center of Excellence. Sixty-one adults with symptomatic oHCM who started on mavacamten between March 2023 and February 2024 were retrospectively identified. All patients had an electrocardiogram performed at each clinic visit, and 72-hour Holter monitoring was performed at 12- and 24-week visits. The mean age was 57.2 ± 14.5 years; 32 (51.6%) patients were female. Of the 61 patients, 45 completed a 24-week period and were the main subject of this study. After 6 months of treatment, the proportion of patients in Grade 1 diastolic dysfunction increased from 26.6% to 62.2%, p = 0.001, and the proportion in Grade 2 diastolic dysfunction decreased from 66.6% to 35.5%, p = 0.006; 26.7% (n = 12/45) of patients improved by 2 New York Heart Association functional classes and 46.7% (n = 21/45) by 1. GLS remained stable over time. At week 24, 35 of 45 patients (77.7%) had a left ventricular outflow tract gradient ≤30 mmHg. No arrhythmia burden or major side effects were reported. Left ventricular ejection fraction remained above 55% in all but 1 patient, who recovered within a month. In conclusion, our experience of significantly improved diastology and stable GLS after mavacamten treatment aligns with trial outcomes. Longitudinal investigations are needed to further assess the long-term impacts.
{"title":"Real-World Assessment of Mavacamten's Impact on Left Ventricular Systolic and Diastolic Functions in Obstructive Hypertrophic Cardiomyopathy: A 1-Year Single-Center Observational Study","authors":"Zaid Abood MD ,&nbsp;M. Fuad Jan MBBS (Hons), MD ,&nbsp;Muddasir Ashraf MD ,&nbsp;Prabhjot Hundal MD ,&nbsp;Lauren Howard BS, RDCS (AE, PE), RVT ,&nbsp;Heather Sanders NP ,&nbsp;Amanda Misicka RN ,&nbsp;Asad Ghafoor MD ,&nbsp;Arshad Jahangir MD ,&nbsp;Patrycja Galazka MD ,&nbsp;A. Jamil Tajik MD","doi":"10.1016/j.amjcard.2025.01.032","DOIUrl":"10.1016/j.amjcard.2025.01.032","url":null,"abstract":"<div><div>Real-world data on the effects of mavacamten on diastology and global longitudinal strain (GLS) in symptomatic patients with obstructive hypertrophic cardiomyopathy (oHCM) are limited. We share our experience with mavacamten over a 24-week period at an HCM Center of Excellence. Sixty-one adults with symptomatic oHCM who started on mavacamten between March 2023 and February 2024 were retrospectively identified. All patients had an electrocardiogram performed at each clinic visit, and 72-hour Holter monitoring was performed at 12- and 24-week visits. The mean age was 57.2 ± 14.5 years; 32 (51.6%) patients were female. Of the 61 patients, 45 completed a 24-week period and were the main subject of this study. After 6 months of treatment, the proportion of patients in Grade 1 diastolic dysfunction increased from 26.6% to 62.2%, p = 0.001, and the proportion in Grade 2 diastolic dysfunction decreased from 66.6% to 35.5%, p = 0.006; 26.7% (n = 12/45) of patients improved by 2 New York Heart Association functional classes and 46.7% (n = 21/45) by 1. GLS remained stable over time. At week 24, 35 of 45 patients (77.7%) had a left ventricular outflow tract gradient ≤30 mmHg. No arrhythmia burden or major side effects were reported. Left ventricular ejection fraction remained above 55% in all but 1 patient, who recovered within a month. In conclusion, our experience of significantly improved diastology and stable GLS after mavacamten treatment aligns with trial outcomes. Longitudinal investigations are needed to further assess the long-term impacts.</div></div>","PeriodicalId":7705,"journal":{"name":"American Journal of Cardiology","volume":"242 ","pages":"Pages 68-74"},"PeriodicalIF":2.3,"publicationDate":"2025-01-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143078397","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Do Novel Antidiabetic Therapies Reduce the Risk of Contrast-Associated Acute Kidney Injury?
IF 2.3 3区 医学 Q2 CARDIAC & CARDIOVASCULAR SYSTEMS Pub Date : 2025-01-31 DOI: 10.1016/j.amjcard.2025.01.027
Anand Shah, George A Stouffer
{"title":"Do Novel Antidiabetic Therapies Reduce the Risk of Contrast-Associated Acute Kidney Injury?","authors":"Anand Shah, George A Stouffer","doi":"10.1016/j.amjcard.2025.01.027","DOIUrl":"10.1016/j.amjcard.2025.01.027","url":null,"abstract":"","PeriodicalId":7705,"journal":{"name":"American Journal of Cardiology","volume":" ","pages":""},"PeriodicalIF":2.3,"publicationDate":"2025-01-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143078383","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Acute Aortic Dissection Entrapped by ST-Elevation Myocardial Infarction: The Role of Echocardiography
IF 2.3 3区 医学 Q2 CARDIAC & CARDIOVASCULAR SYSTEMS Pub Date : 2025-01-31 DOI: 10.1016/j.amjcard.2025.01.026
Bülent Özlek MD, Süleyman Barutçu MD
{"title":"Acute Aortic Dissection Entrapped by ST-Elevation Myocardial Infarction: The Role of Echocardiography","authors":"Bülent Özlek MD,&nbsp;Süleyman Barutçu MD","doi":"10.1016/j.amjcard.2025.01.026","DOIUrl":"10.1016/j.amjcard.2025.01.026","url":null,"abstract":"","PeriodicalId":7705,"journal":{"name":"American Journal of Cardiology","volume":"242 ","pages":"Page 24"},"PeriodicalIF":2.3,"publicationDate":"2025-01-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143078381","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Peri-Procedural Outcomes of Left Atrial Appendage Occlusion in Lower Versus Higher CHA2DS2-VASc Score
IF 2.3 3区 医学 Q2 CARDIAC & CARDIOVASCULAR SYSTEMS Pub Date : 2025-01-31 DOI: 10.1016/j.amjcard.2025.01.033
Rafey Feroze MD , Yusef Saeed MD , Waqas Ullah MD , Nawaf Alhabdan MD , Alexander Cove MD , Marco Frazzetto MD , Nour Tashtish MD , Luis Augusto Palma Dallan MD, PhD , Steven J. Filby MD
Percutaneous left atrial appendage occlusion (LAAO) is used to prevent stroke in atrial fibrillation. We present a national registry analysis of peri‑procedural outcomes of LAAO among patients with lower versus higher CHA2DS2-VASc score. The National Readmissions Database was used to perform a retrospective review of all hospitalizations for percutaneous endocardial LAAO identified between September 2015 and November 2019. ICD codes for congestive heart failure, hypertension, type 2 diabetes, stroke, transient ischemic attack, thromboembolism, and vascular disease were identified. CHA2DS2-VASc was calculated. Lower CHA2DS2-VASc score was defined as <5 and higher score as ≥5. Propensity matched (PSM) analysis at index hospitalization and 30 days was used to compare a matched sample of patients undergoing LAAO with lower and higher CHA2DS2-VASc. Outcomes examined included all-cause mortality, stroke, major bleeding, pericardial effusion, and cardiac tamponade. A sample of patients who underwent LAAO with lower CHA2DS2-VASc (n = 40,879) and higher CHA2DS2-VASc (n = 14,438) was identified for crude analysis. From this cohort, a sample of patients with lower CHA2DS2-VASc (n = 14,219) and higher CHA2DS2-VASc (n = 14,388) was selected for PSM analysis. Both crude and PSM analyses at index hospitalization found higher odds of mortality in the higher CHA2DS2-VASc group but no significant difference in odds of major bleeding, stroke, pericardial effusion, or cardiac tamponade. Our findings showed associated a higher CHA2DS2-VASc score with a higher risk of mortality without an increased risk of common complications peri‑procedurally. In conclusion, findings display the overall safety of LAAO for patients with both lower and higher CHA2DS2-VASc score.
{"title":"Peri-Procedural Outcomes of Left Atrial Appendage Occlusion in Lower Versus Higher CHA2DS2-VASc Score","authors":"Rafey Feroze MD ,&nbsp;Yusef Saeed MD ,&nbsp;Waqas Ullah MD ,&nbsp;Nawaf Alhabdan MD ,&nbsp;Alexander Cove MD ,&nbsp;Marco Frazzetto MD ,&nbsp;Nour Tashtish MD ,&nbsp;Luis Augusto Palma Dallan MD, PhD ,&nbsp;Steven J. Filby MD","doi":"10.1016/j.amjcard.2025.01.033","DOIUrl":"10.1016/j.amjcard.2025.01.033","url":null,"abstract":"<div><div>Percutaneous left atrial appendage occlusion (LAAO) is used to prevent stroke in <span><span>atrial</span><svg><path></path></svg></span> fibrillation. We present a national registry analysis of peri‑procedural outcomes of LAAO among patients with lower versus higher CHA<sub>2</sub>DS<sub>2</sub>-VASc score. The National Readmissions Database was used to perform a retrospective review of all hospitalizations for percutaneous endocardial LAAO identified between September 2015 and November 2019. ICD codes for congestive heart failure, hypertension, type 2 diabetes, stroke, transient ischemic attack, thromboembolism, and vascular disease were identified. CHA<sub>2</sub>DS<sub>2</sub>-VASc was calculated. Lower CHA<sub>2</sub>DS<sub>2</sub>-VASc score was defined as &lt;5 and higher score as ≥5. Propensity matched (PSM) analysis at index hospitalization and 30 days was used to compare a matched sample of patients undergoing LAAO with lower and higher CHA<sub>2</sub>DS<sub>2</sub>-VASc. Outcomes examined included all-cause mortality, stroke, major bleeding, pericardial effusion, and cardiac tamponade. A sample of patients who underwent LAAO with lower CHA<sub>2</sub>DS<sub>2</sub>-VASc (n = 40,879) and higher CHA<sub>2</sub>DS<sub>2</sub>-VASc (n = 14,438) was identified for crude analysis. From this cohort, a sample of patients with lower CHA<sub>2</sub>DS<sub>2</sub>-VASc (n = 14,219) and higher CHA<sub>2</sub>DS<sub>2</sub>-VASc (n = 14,388) was selected for PSM analysis. Both crude and PSM analyses at index hospitalization found higher odds of mortality in the higher CHA<sub>2</sub>DS<sub>2</sub>-VASc group but no significant difference in odds of major bleeding, stroke, pericardial effusion, or cardiac tamponade. Our findings showed associated a higher CHA<sub>2</sub>DS<sub>2</sub>-VASc score with a higher risk of mortality without an increased risk of common complications peri‑procedurally. In conclusion, findings display the overall safety of LAAO for patients with both lower and higher CHA<sub>2</sub>DS<sub>2</sub>-VASc score.</div></div>","PeriodicalId":7705,"journal":{"name":"American Journal of Cardiology","volume":"242 ","pages":"Pages 61-67"},"PeriodicalIF":2.3,"publicationDate":"2025-01-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143078386","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Tobacco Exposure and Markers of Myocardial Stress and Damage Among US Adults
IF 2.3 3区 医学 Q2 CARDIAC & CARDIOVASCULAR SYSTEMS Pub Date : 2025-01-31 DOI: 10.1016/j.amjcard.2025.01.028
Molly E. Schwalb PhD, MPH , John William McEvoy MB BCh, PhD , Ana Navas-Acien MD, PhD , Amelia S. Wallace PhD , Mary R. Rooney PhD , Elizabeth Selvin PhD , Robert H. Christenson PhD , Miranda R. Jones PhD
{"title":"Tobacco Exposure and Markers of Myocardial Stress and Damage Among US Adults","authors":"Molly E. Schwalb PhD, MPH ,&nbsp;John William McEvoy MB BCh, PhD ,&nbsp;Ana Navas-Acien MD, PhD ,&nbsp;Amelia S. Wallace PhD ,&nbsp;Mary R. Rooney PhD ,&nbsp;Elizabeth Selvin PhD ,&nbsp;Robert H. Christenson PhD ,&nbsp;Miranda R. Jones PhD","doi":"10.1016/j.amjcard.2025.01.028","DOIUrl":"10.1016/j.amjcard.2025.01.028","url":null,"abstract":"","PeriodicalId":7705,"journal":{"name":"American Journal of Cardiology","volume":"243 ","pages":"Pages 19-21"},"PeriodicalIF":2.3,"publicationDate":"2025-01-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143078399","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Health Status Improvement After Peripheral Vascular Intervention: Insights From the LIBERTY 360 Study
IF 2.3 3区 医学 Q2 CARDIAC & CARDIOVASCULAR SYSTEMS Pub Date : 2025-01-31 DOI: 10.1016/j.amjcard.2025.01.017
Ramya C. Mosarla MD , Mohsin Chowdhury MD , Kim G. Smolderen PhD, MSc , Carlos Mena-Hurtado MD , John Spertus MD, MPH , Robert W. Yeh MD, MBA , Eric A. Secemsky MD, MSc
Improving health status is a primary indication for peripheral endovascular intervention (PVI) for symptomatic peripheral arterial disease. The data informing mid- and long-term changes and predictors of health status following PVI are limited. LIBERTY 360, a prospective, nonrandomized, multicenter study evaluated outcomes in patients undergoing PVI. Health status measures were assessed at 30-days, 1 and 3-years using EQ-VAS (0-100,100 best health) and VascuQol-25 (1-7,7 best health), stratified by claudication (Rutherford 2-3), and chronic limb-threatening ischemia (CLTI, Rutherford 4-6). Multivariable regression identified predictors of health status at 1-year. Repeated measures models were constructed based on patients with available data through 3 years. Outcomes including major adverse events, all-cause death, major amputation/death, target vessel/lesion revascularization, and major adverse limb events (MALE)/post-operative death were reported. Claudication (n = 501, 41.6%) had higher baseline VascuQol total scores (4.3 ± 1.3) compared to CLTI (n = 703, 58.4%) (3.8 ± 1.4). The VascuQol total score improved at 30-days with claudication (5.4 ± 1.3, p < 0.0001) and CLTI (4.7 ± 1.4, p < 0.0001). Baseline EQ-VAS was higher with claudication (68.3 ± 19.7) than with CLTI (63.1 ± 20.1). EQ-VAS improved at 30-days with claudication (74.9 ± 17.9, p < 0.0001) and CLTI (68.6 ± 19.2, p-value:<0.0001). Improvements were maintained through 3-years. Baseline health status, history of PVI, and comorbidities predicted health status after PVI. While major adverse events rates were high at 3-years, this was driven by target vessel/lesion revascularization with high rates of freedom from major amputation, all-cause death, and MALE in both groups. In conclusion, PVI is associated with mid- long-term improvements in health status across peripheral arterial disease severity. Baseline characteristics were associated with health status at 1-year and may inform patient selection.
{"title":"Health Status Improvement After Peripheral Vascular Intervention: Insights From the LIBERTY 360 Study","authors":"Ramya C. Mosarla MD ,&nbsp;Mohsin Chowdhury MD ,&nbsp;Kim G. Smolderen PhD, MSc ,&nbsp;Carlos Mena-Hurtado MD ,&nbsp;John Spertus MD, MPH ,&nbsp;Robert W. Yeh MD, MBA ,&nbsp;Eric A. Secemsky MD, MSc","doi":"10.1016/j.amjcard.2025.01.017","DOIUrl":"10.1016/j.amjcard.2025.01.017","url":null,"abstract":"<div><div>Improving health status is a primary indication for peripheral endovascular intervention (PVI) for symptomatic peripheral arterial disease. The data informing mid- and long-term changes and predictors of health status following PVI are limited. LIBERTY 360, a prospective, nonrandomized, multicenter study evaluated outcomes in patients undergoing PVI. Health status measures were assessed at 30-days, 1 and 3-years using EQ-VAS (0-100,100 best health) and VascuQol-25 (1-7,7 best health), stratified by claudication (Rutherford 2-3), and chronic limb-threatening ischemia (CLTI, Rutherford 4-6). Multivariable regression identified predictors of health status at 1-year. Repeated measures models were constructed based on patients with available data through 3 years. Outcomes including major adverse events, all-cause death, major amputation/death, target vessel/lesion revascularization, and major adverse limb events (MALE)/post-operative death were reported. Claudication (n = 501, 41.6%) had higher baseline VascuQol total scores (4.3 ± 1.3) compared to CLTI (n = 703, 58.4%) (3.8 ± 1.4). The VascuQol total score improved at 30-days with claudication (5.4 ± 1.3, p &lt; 0.0001) and CLTI (4.7 ± 1.4, p &lt; 0.0001). Baseline EQ-VAS was higher with claudication (68.3 ± 19.7) than with CLTI (63.1 ± 20.1). EQ-VAS improved at 30-days with claudication (74.9 ± 17.9, p &lt; 0.0001) and CLTI (68.6 ± 19.2, p-value:&lt;0.0001). Improvements were maintained through 3-years. Baseline health status, history of PVI, and comorbidities predicted health status after PVI. While major adverse events rates were high at 3-years, this was driven by target vessel/lesion revascularization with high rates of freedom from major amputation, all-cause death, and MALE in both groups. In conclusion, PVI is associated with mid- long-term improvements in health status across peripheral arterial disease severity. Baseline characteristics were associated with health status at 1-year and may inform patient selection.</div></div>","PeriodicalId":7705,"journal":{"name":"American Journal of Cardiology","volume":"243 ","pages":"Pages 22-31"},"PeriodicalIF":2.3,"publicationDate":"2025-01-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143078385","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Comparison of Provisional 1-Stent Strategy With Drug-Eluting Balloon Versus Planned 2-Stent Strategy in Patients With Non-LM Coronary True-Bifurcation Lesions (PROVISION-DEB)
IF 2.3 3区 医学 Q2 CARDIAC & CARDIOVASCULAR SYSTEMS Pub Date : 2025-01-29 DOI: 10.1016/j.amjcard.2025.01.025
Sang-Suk Choi MD , Jin Jung MD, PhD , Kyunyeon Kim MD , Sung-Ho Her MD, PhD , Kyusup Lee MD, PhD , Doo-Soo Jeon MD, PhD , Byung-Hee Hwang MD, PhD , Chul Soo Park MD, PhD , Sungmin Lim MD, PhD , Suk Min Seo MD, PhD , Jisu Mok MD, PhD , Seung Hwan Han MD, PhD , Sung Uk Kwon MD, PhD , Joo-Yong Hahn MD, PhD , Seung-Whan Lee MD, PhD , Woong Gil Choi MD, PhD
Percutaneous coronary intervention (PCI) for bifurcation lesions presents several difficulties and often results in suboptimal procedural, postprocedural clinical outcomes. While the provisional 1-stent strategy is generally favored for its simplicity and favorable outcomes, a few studies suggest no significant difference between 1-stent and 2-stent techniques for true bifurcation lesions. Drug-eluting balloons (DEBs) have demonstrated potential in small vessel disease, including bifurcation side branches. However, no studies have compared the 2-stent strategy with the provisional 1-stent plus DEB strategy in non-LM true bifurcation lesions. Our study aims to address this gap by comparing these strategies, with a focus on real-world practice and detailed endpoint analysis. The PROVISION-DEB study is an open-label, randomized, multicenter clinical trial designed to investigate noninferiority and compare a 1-stent strategy with a drug-eluting balloon and a planned 2-stent strategy at non-LM coronary true-bifurcation lesions. A total of 750 patients with de novo non-LM coronary bifurcation lesions undergoing coronary interventions will be randomized 1:1 to either a provisional 1-stent plus DEB strategy or a 2-stent strategy with stratified Diabetes. The primary endpoint is a target lesion failure, composite outcome of cardiac death, target vessel myocardial infarction, or target lesion revascularization at the anticipated 3 years follow-up (6, 12, and 36 months). In conclusion, PROVISION-DEB study is a randomized, multicenter, noninferior clinical trial and will compare a 1-setnt strategy with a drug-eluting balloon and a planned 2-stent strategy at non-LM coronary true-bifurcation.
{"title":"Comparison of Provisional 1-Stent Strategy With Drug-Eluting Balloon Versus Planned 2-Stent Strategy in Patients With Non-LM Coronary True-Bifurcation Lesions (PROVISION-DEB)","authors":"Sang-Suk Choi MD ,&nbsp;Jin Jung MD, PhD ,&nbsp;Kyunyeon Kim MD ,&nbsp;Sung-Ho Her MD, PhD ,&nbsp;Kyusup Lee MD, PhD ,&nbsp;Doo-Soo Jeon MD, PhD ,&nbsp;Byung-Hee Hwang MD, PhD ,&nbsp;Chul Soo Park MD, PhD ,&nbsp;Sungmin Lim MD, PhD ,&nbsp;Suk Min Seo MD, PhD ,&nbsp;Jisu Mok MD, PhD ,&nbsp;Seung Hwan Han MD, PhD ,&nbsp;Sung Uk Kwon MD, PhD ,&nbsp;Joo-Yong Hahn MD, PhD ,&nbsp;Seung-Whan Lee MD, PhD ,&nbsp;Woong Gil Choi MD, PhD","doi":"10.1016/j.amjcard.2025.01.025","DOIUrl":"10.1016/j.amjcard.2025.01.025","url":null,"abstract":"<div><div>Percutaneous coronary intervention (PCI) for bifurcation lesions presents several difficulties and often results in suboptimal procedural, postprocedural clinical outcomes. While the provisional 1-stent strategy is generally favored for its simplicity and favorable outcomes, a few studies suggest no significant difference between 1-stent and 2-stent techniques for true bifurcation lesions. Drug-eluting balloons (DEBs) have demonstrated potential in small vessel disease, including bifurcation side branches. However, no studies have compared the 2-stent strategy with the provisional 1-stent plus DEB strategy in non-LM true bifurcation lesions. Our study aims to address this gap by comparing these strategies, with a focus on real-world practice and detailed endpoint analysis. The PROVISION-DEB study is an open-label, randomized, multicenter clinical trial designed to investigate noninferiority and compare a 1-stent strategy with a drug-eluting balloon and a planned 2-stent strategy at non-LM coronary true-bifurcation lesions. A total of 750 patients with de novo non-LM coronary bifurcation lesions undergoing coronary interventions will be randomized 1:1 to either a provisional 1-stent plus DEB strategy or a 2-stent strategy with stratified Diabetes. The primary endpoint is a target lesion failure, composite outcome of cardiac death, target vessel myocardial infarction, or target lesion revascularization at the anticipated 3 years follow-up (6, 12, and 36 months). In conclusion, PROVISION-DEB study is a randomized, multicenter, noninferior clinical trial and will compare a 1-setnt strategy with a drug-eluting balloon and a planned 2-stent strategy at non-LM coronary true-bifurcation.</div></div>","PeriodicalId":7705,"journal":{"name":"American Journal of Cardiology","volume":"242 ","pages":"Pages 18-23"},"PeriodicalIF":2.3,"publicationDate":"2025-01-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143073482","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Long Term Efficacy and Safety of Cardiac Resynchronization Therapy in Adult Congenital Heart Disease Patients: A Single Center Cohort Study
IF 2.3 3区 医学 Q2 CARDIAC & CARDIOVASCULAR SYSTEMS Pub Date : 2025-01-29 DOI: 10.1016/j.amjcard.2025.01.011
Nili Schamroth Pravda MbbCh , Ilan Richter MD , Ofir Brem BA , Daniel Yehuda MD , Ori Rahat MD , Hadas Ofek MD , Shir Tal MD , Ran Kornowski MD , Shahar Vig MD , Kirill Buturlin MD , Rafael Hirsch MD , Gregory Golovchiner MD
Heart failure constitutes a major cause for morbidity amongst patients with adult congenital heart disease (ACHD). Cardiac resynchronization therapy (CRT) is a recommended therapeutic measure for patients with heart failure. Data on the efficacy and safety of CRT amongst patients with ACHD is limited. This study analyzed data from a retrospective cohort of patients with ACHD and implantation of CRT between 2015 and 2022. The primary outcome was echocardiographic response to CRT, defined as either: (1) an increase in systemic ventricular ejection fraction (EF) of ≥ 5% in patients with baseline EF <50% (therapeutic efficacy) or (2) maintenance of EF in patients with EF ≥ 50% (preventative efficacy). The outcomes were assessed by subgroups of systemic left or right ventricle ventricle. In a cohort of 45 patients, mean age was 54 ± 14 years, 26 patients had a systemic left ventricle (57.8%) and 19 patients had a systemic right ventricle (42.2%). The average follow-up was 5.2 ± 0.5 years. Primary outcome amongst patients with reduced EF at baseline was achieved in 69.0%; and in 92.3% amongst patients with preserved EF at baseline. There was no significant difference in the response to CRT as per systemic left or right ventricle (p = 0.15) or per baseline EF (p = 0.10). Complications occurred in 28.9% of patients. In conclusion, CRT appears to be effective in patients with ACHD in reducing rates of heart failure, regardless of baseline EF or systemic ventricle morphology. The percentage of patients with a safety outcome was relatively high and highlights the need for careful patient selection.
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引用次数: 0
Use of Nonsteroidal Anti-Inflammatory Drugs for Pericarditis in Pregnancy
IF 2.3 3区 医学 Q2 CARDIAC & CARDIOVASCULAR SYSTEMS Pub Date : 2025-01-27 DOI: 10.1016/j.amjcard.2025.01.024
Lisa Serati, Lucia Trotta, Enrica Negro, Antonio Brucato
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引用次数: 0
Informed Consent and Shared Decision-Making in Modern Medicine: Case-Based Approach, Current Gaps and Practical Proposal
IF 2.3 3区 医学 Q2 CARDIAC & CARDIOVASCULAR SYSTEMS Pub Date : 2025-01-25 DOI: 10.1016/j.amjcard.2025.01.015
Giuseppe Tarantini MD, PhD, FESC , Chiara Fraccaro MD, PhD , Andrea Porzionato MD, PhD , Nicolas Van Mieghem MD, PhD , Hendrik Treede MD, PhD , Nicolas Shammas MD, FACC , Molly Szerlip MD, FACP, FACC, FSCAI , Vinod Thourani MD, FACC , Gino Gerosa MD , Alfredo Marchese MD, PhD , Giuseppe Speziale MD, PhD , Bertrand Ludes MD, PhD , Stephen Pollak MD, PhD , Peter Vanezis MD, PhD , Santo Davide Ferrara MD, PhD
Advances in personalized medicine and Systems Biology have introduced probabilistic models and error discovery to cardiovascular care, aiding disease prevention and procedural planning. However, clinical application faces cultural, technical, and methodological hurdles. Patient autonomy remains essential, with shared decision-making (SDM) gaining importance in managing complex cardiovascular treatment options. Effective SDM relies on collaboration between providers and patients, guided by P5 Medicine principles, which combine psycho-cognitive considerations with predictive, personalized, preventive, and participatory care. Here we propose a 3-step methodological proposal for implementing SDM and enhancing consent acquisition in cardiovascular care. The approach emphasizes personalized patient engagement and the need for clear, comprehensive consent processes. It identifies and addresses significant gaps in current practices, including the complexity of consent language, information dispersion, and the specific needs of vulnerable populations. Issues of Medical Responsibility and/or Liability may raise in the case of absence of consent acquisition or invalid consent due to insufficient/incorrect information. The International Guidelines on Medico-Legal Methods of Ascertainment and Evaluation Criteria are reported. In conclusion, the paper proposes practical solutions, including the use of artificial intelligence (AI) to enhance decision-making and patient counseling, and strategies to ensure that consent processes are both thorough and legally sound and respectful to the individual's autonomy.
{"title":"Informed Consent and Shared Decision-Making in Modern Medicine: Case-Based Approach, Current Gaps and Practical Proposal","authors":"Giuseppe Tarantini MD, PhD, FESC ,&nbsp;Chiara Fraccaro MD, PhD ,&nbsp;Andrea Porzionato MD, PhD ,&nbsp;Nicolas Van Mieghem MD, PhD ,&nbsp;Hendrik Treede MD, PhD ,&nbsp;Nicolas Shammas MD, FACC ,&nbsp;Molly Szerlip MD, FACP, FACC, FSCAI ,&nbsp;Vinod Thourani MD, FACC ,&nbsp;Gino Gerosa MD ,&nbsp;Alfredo Marchese MD, PhD ,&nbsp;Giuseppe Speziale MD, PhD ,&nbsp;Bertrand Ludes MD, PhD ,&nbsp;Stephen Pollak MD, PhD ,&nbsp;Peter Vanezis MD, PhD ,&nbsp;Santo Davide Ferrara MD, PhD","doi":"10.1016/j.amjcard.2025.01.015","DOIUrl":"10.1016/j.amjcard.2025.01.015","url":null,"abstract":"<div><div>Advances in personalized medicine and Systems Biology have introduced probabilistic models and error discovery to cardiovascular care, aiding disease prevention and procedural planning. However, clinical application faces cultural, technical, and methodological hurdles. Patient autonomy remains essential, with shared decision-making (SDM) gaining importance in managing complex cardiovascular treatment options. Effective SDM relies on collaboration between providers and patients, guided by P5 Medicine principles, which combine psycho-cognitive considerations with predictive, personalized, preventive, and participatory care. Here we propose a 3-step methodological proposal for implementing SDM and enhancing consent acquisition in cardiovascular care. The approach emphasizes personalized patient engagement and the need for clear, comprehensive consent processes. It identifies and addresses significant gaps in current practices, including the complexity of consent language, information dispersion, and the specific needs of vulnerable populations. Issues of Medical Responsibility and/or Liability may raise in the case of absence of consent acquisition or invalid consent due to insufficient/incorrect information. The International Guidelines on Medico-Legal Methods of Ascertainment and Evaluation Criteria are reported. In conclusion, the paper proposes practical solutions, including the use of artificial intelligence (AI) to enhance decision-making and patient counseling, and strategies to ensure that consent processes are both thorough and legally sound and respectful to the individual's autonomy.</div></div>","PeriodicalId":7705,"journal":{"name":"American Journal of Cardiology","volume":"241 ","pages":"Pages 77-83"},"PeriodicalIF":2.3,"publicationDate":"2025-01-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143051366","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
期刊
American Journal of Cardiology
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