JAMA cardiologyPub Date : 2024-11-06DOI: 10.1001/jamacardio.2024.3764
Gregg C Fonarow, James E Udelson, Clyde W Yancy
{"title":"Heart Failure With Preserved Ejection Fraction-A Role for Invasive Hemodynamics.","authors":"Gregg C Fonarow, James E Udelson, Clyde W Yancy","doi":"10.1001/jamacardio.2024.3764","DOIUrl":"https://doi.org/10.1001/jamacardio.2024.3764","url":null,"abstract":"","PeriodicalId":14657,"journal":{"name":"JAMA cardiology","volume":null,"pages":null},"PeriodicalIF":14.8,"publicationDate":"2024-11-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142583085","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
JAMA cardiologyPub Date : 2024-11-06DOI: 10.1001/jamacardio.2024.3767
Jwan A Naser, Tomonari Harada, Yogesh N Reddy, Sorin V Pislaru, Hector I Michelena, Christopher G Scott, Austin M Kennedy, Patricia A Pellikka, Vuyisile T Nkomo, Mackram F Eleid, Barry A Borlaug
{"title":"Prevalence of HFpEF in Isolated Severe Secondary Tricuspid Regurgitation.","authors":"Jwan A Naser, Tomonari Harada, Yogesh N Reddy, Sorin V Pislaru, Hector I Michelena, Christopher G Scott, Austin M Kennedy, Patricia A Pellikka, Vuyisile T Nkomo, Mackram F Eleid, Barry A Borlaug","doi":"10.1001/jamacardio.2024.3767","DOIUrl":"https://doi.org/10.1001/jamacardio.2024.3767","url":null,"abstract":"<p><strong>Importance: </strong>Secondary tricuspid regurgitation (STR) is observed in multiple cardiac and pulmonary diseases. Heart failure with preserved ejection fraction (HFpEF) is a common cause of STR that may be overlooked, along with precapillary etiologies of pulmonary hypertension (PH).</p><p><strong>Objectives: </strong>To investigate the prevalence of HFpEF and precapillary PH in patients with severe STR of undefined etiology (isolated STR) referred for exercise right heart catheterization (RHC), and to evaluate the performance of noninvasive measures to identify HFpEF.</p><p><strong>Design, setting, and participants: </strong>This retrospective cross-sectional study included consecutive adults with severe STR in the absence of EF less than 50%, hemodynamically significant left-sided valve disease, congenital heart disease, infiltrative or hypertrophic cardiomyopathy, pericardial disease, or prior cardiac procedures who underwent rest-and-exercise RHC between February 2006 and June 2023 at Mayo Clinic and transthoracic echocardiography less than 90 days prior. Diastolic dysfunction (DD) was defined by at least 3 of 4 or 2 of 3 abnormal diastolic parameters (medial e', medial E/e', tricuspid regurgitation [TR] velocity, left atrial volume index). HFpEF was diagnosed when pulmonary arterial wedge pressure was at least 15 mm Hg at rest, at least 19 mm Hg with feet up, or at least 25 mm Hg during exercise. Data analysis was performed from November 2023 to March 2024.</p><p><strong>Main outcomes and measures: </strong>The prevalence of HFpEF and precapillary PH in severe isolated STR was determined, and performance of noninvasive measures to identify HFpEF was evaluated.</p><p><strong>Results: </strong>Overall, 54 patients with severe isolated STR (mean [SD] age, 70.8 [12.5] years; 34 [63%] female) were identified. The primary indication for RHC was evaluation of TR prior to potential intervention in 36 patients (67%), evaluation of PH in 13 (24%), and confirmation of HFpEF in 5 (9%). HFpEF was identified in 40 patients (74%) but was recognized prior to RHC in only 19 patients (35%). Of the 14 remaining patients without HFpEF, precapillary PH was diagnosed in 10 (71%). Guideline-defined DD was absent in 24 patients (60%) who were subsequently diagnosed with HFpEF. Left atrial emptying fraction (area under the receiver operating characteristic curve [AUC] = 0.90; 95% CI, 0.82-0.98) and strain (AUC = 0.91; 95% CI, 0.83-0.99) had robust discrimination for HFpEF.</p><p><strong>Conclusions and relevance: </strong>The findings suggest that HFpEF is underdiagnosed and should be rigorously evaluated for in patients with severe isolated STR, along with precapillary PH, as both have distinct requirements for management. Resting DD based on current guidelines is insufficiently sensitive in these patients, indicating a pressing need for other noninvasive diagnostic tools, such as left atrial function assessment.</p>","PeriodicalId":14657,"journal":{"name":"JAMA cardiology","volume":null,"pages":null},"PeriodicalIF":14.8,"publicationDate":"2024-11-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142583088","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
JAMA cardiologyPub Date : 2024-11-06DOI: 10.1001/jamacardio.2024.3749
Mark C Blaser, Elena Aikawa
{"title":"Disease Drivers in Aortic Stenosis vs Atherosclerosis.","authors":"Mark C Blaser, Elena Aikawa","doi":"10.1001/jamacardio.2024.3749","DOIUrl":"https://doi.org/10.1001/jamacardio.2024.3749","url":null,"abstract":"","PeriodicalId":14657,"journal":{"name":"JAMA cardiology","volume":null,"pages":null},"PeriodicalIF":14.8,"publicationDate":"2024-11-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142583080","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
JAMA cardiologyPub Date : 2024-11-06DOI: 10.1001/jamacardio.2024.3738
Teresa Trenkwalder, Carlo Maj, Baravan Al-Kassou, Radoslaw Debiec, Stefanie A Doppler, Muntaser D Musameh, Christopher P Nelson, Pouria Dasmeh, Sandeep Grover, Katharina Knoll, Joonas Naamanka, Ify R Mordi, Peter S Braund, Martina Dreßen, Harald Lahm, Felix Wirth, Stephan Baldus, Malte Kelm, Moritz von Scheidt, Johannes Krefting, David Ellinghaus, Aeron M Small, Gina M Peloso, Pradeep Natarajan, George Thanassoulis, James C Engert, Line Dufresne, Andre Franke, Siegfried Görg, Matthias Laudes, Ulrike Nowak-Göttl, Mariliis Vaht, Andres Metspalu, Monika Stoll, Klaus Berger, Costanza Pellegrini, Adnan Kastrati, Christian Hengstenberg, Chim C Lang, Thorsten Kessler, Iiris Hovatta, Georg Nickenig, Markus M Nöthen, Markus Krane, Heribert Schunkert, Nilesh J Samani, Johannes Schumacher, Mart Kals, Anu Reigo, Maris Teder-Laving, Jan Gehlen, Thomas R Webb, Ann-Sophie Giel, Laura L Koebbe, Nina Feirer, Maximilian Billmann, Sundar Srinivasan, Sebastian Zimmer, Colin N A Palmer, Ling Li, Chuhua Yang, Oleg Borisov, Matti Adam, Verena Veulemans, Michael Joner, Erion Xhepa
{"title":"Distinct Genetic Risk Profile in Aortic Stenosis Compared With Coronary Artery Disease.","authors":"Teresa Trenkwalder, Carlo Maj, Baravan Al-Kassou, Radoslaw Debiec, Stefanie A Doppler, Muntaser D Musameh, Christopher P Nelson, Pouria Dasmeh, Sandeep Grover, Katharina Knoll, Joonas Naamanka, Ify R Mordi, Peter S Braund, Martina Dreßen, Harald Lahm, Felix Wirth, Stephan Baldus, Malte Kelm, Moritz von Scheidt, Johannes Krefting, David Ellinghaus, Aeron M Small, Gina M Peloso, Pradeep Natarajan, George Thanassoulis, James C Engert, Line Dufresne, Andre Franke, Siegfried Görg, Matthias Laudes, Ulrike Nowak-Göttl, Mariliis Vaht, Andres Metspalu, Monika Stoll, Klaus Berger, Costanza Pellegrini, Adnan Kastrati, Christian Hengstenberg, Chim C Lang, Thorsten Kessler, Iiris Hovatta, Georg Nickenig, Markus M Nöthen, Markus Krane, Heribert Schunkert, Nilesh J Samani, Johannes Schumacher, Mart Kals, Anu Reigo, Maris Teder-Laving, Jan Gehlen, Thomas R Webb, Ann-Sophie Giel, Laura L Koebbe, Nina Feirer, Maximilian Billmann, Sundar Srinivasan, Sebastian Zimmer, Colin N A Palmer, Ling Li, Chuhua Yang, Oleg Borisov, Matti Adam, Verena Veulemans, Michael Joner, Erion Xhepa","doi":"10.1001/jamacardio.2024.3738","DOIUrl":"10.1001/jamacardio.2024.3738","url":null,"abstract":"<p><strong>Importance: </strong>Aortic stenosis (AS) and coronary artery disease (CAD) frequently coexist. However, it is unknown which genetic and cardiovascular risk factors might be AS-specific and which could be shared between AS and CAD.</p><p><strong>Objective: </strong>To identify genetic risk loci and cardiovascular risk factors with AS-specific associations.</p><p><strong>Design, setting, and participants: </strong>This was a genomewide association study (GWAS) of AS adjusted for CAD with participants from the European Consortium for the Genetics of Aortic Stenosis (EGAS) (recruited 2000-2020), UK Biobank (recruited 2006-2010), Estonian Biobank (recruited 1997-2019), and FinnGen (recruited 1964-2019). EGAS participants were collected from 7 sites across Europe. All participants were of European ancestry, and information on comorbid CAD was available for all participants. Follow-up analyses with GWAS data on cardiovascular traits and tissue transcriptome data were also performed. Data were analyzed from October 2022 to July 2023.</p><p><strong>Exposures: </strong>Genetic variants.</p><p><strong>Main outcomes and measures: </strong>Cardiovascular traits associated with AS adjusted for CAD. Replication was performed in 2 independent AS GWAS cohorts.</p><p><strong>Results: </strong>A total of 18 792 participants with AS and 434 249 control participants were included in this GWAS adjusted for CAD. The analysis found 17 AS risk loci, including 5 loci with novel and independently replicated associations (RNF114A, AFAP1, PDGFRA, ADAMTS7, HAO1). Of all 17 associated loci, 11 were associated with risk specifically for AS and were not associated with CAD (ALPL, PALMD, PRRX1, RNF144A, MECOM, AFAP1, PDGFRA, IL6, TPCN2, NLRP6, HAO1). Concordantly, this study revealed only a moderate genetic correlation of 0.15 (SE, 0.05) between AS and CAD (P = 1.60 × 10-3). Mendelian randomization revealed that serum phosphate was an AS-specific risk factor that was absent in CAD (AS: odds ratio [OR], 1.20; 95% CI, 1.11-1.31; P = 1.27 × 10-5; CAD: OR, 0.97; 95% CI 0.94-1.00; P = .04). Mendelian randomization also found that blood pressure, body mass index, and cholesterol metabolism had substantially lesser associations with AS compared with CAD. Pathway and transcriptome enrichment analyses revealed biological processes and tissues relevant for AS development.</p><p><strong>Conclusions and relevance: </strong>This GWAS adjusted for CAD found a distinct genetic risk profile for AS at the single-marker and polygenic level. These findings provide new targets for future AS research.</p>","PeriodicalId":14657,"journal":{"name":"JAMA cardiology","volume":null,"pages":null},"PeriodicalIF":14.8,"publicationDate":"2024-11-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11541746/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142583083","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
JAMA cardiologyPub Date : 2024-11-06DOI: 10.1001/jamacardio.2024.3822
Alberto Somaschini, Amanda Casirati
{"title":"The Role of Fat in Frailty Assessment Before Transcatheter Aortic Valve Replacement.","authors":"Alberto Somaschini, Amanda Casirati","doi":"10.1001/jamacardio.2024.3822","DOIUrl":"https://doi.org/10.1001/jamacardio.2024.3822","url":null,"abstract":"","PeriodicalId":14657,"journal":{"name":"JAMA cardiology","volume":null,"pages":null},"PeriodicalIF":14.8,"publicationDate":"2024-11-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142583099","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
JAMA cardiologyPub Date : 2024-10-30DOI: 10.1001/jamacardio.2024.4266
Suzanne V Arnold, John A Spertus, Kensey Gosch, Shannon M Dunlay, Danielle M Olds, Philip G Jones, Fraser D Bocell, Changfu Wu, David J Cohen
{"title":"Validation of the Kansas City Cardiomyopathy Questionnaire in Patients With Tricuspid Regurgitation.","authors":"Suzanne V Arnold, John A Spertus, Kensey Gosch, Shannon M Dunlay, Danielle M Olds, Philip G Jones, Fraser D Bocell, Changfu Wu, David J Cohen","doi":"10.1001/jamacardio.2024.4266","DOIUrl":"10.1001/jamacardio.2024.4266","url":null,"abstract":"<p><strong>Importance: </strong>Improving patients' health status is a key goal of treating tricuspid regurgitation (TR). The Kansas City Cardiomyopathy Questionnaire (KCCQ) is a heart failure disease-specific health status measure used to capture the health status impact of TR and the benefit of transcatheter tricuspid valve intervention (TTVI), but its validity in this clinical setting is unknown.</p><p><strong>Objective: </strong>To evaluate the psychometric properties of the KCCQ in patients with TR.</p><p><strong>Design, setting, and participants: </strong>Data were pooled from patients with severe TR enrolled in 11 manufacturer-sponsored trials of TTVI. The data were transferred to the US Food and Drug Administration to harmonize and anonymize prior to analysis by an independent center. Data were collected from December 2015 to April 2023, and data analysis was performed from July to October 2023.</p><p><strong>Main outcomes and measures: </strong>Prespecified analyses included evaluation of internal consistency, reproducibility, responsiveness, construct validity, and predictive validity. Outcomes were determined using Cronbach α, score comparisons, intraclass correlation, Cohen d, Spearman correlations with best available reference measures, and association of scores and changes in scores with risk of subsequent clinical events.</p><p><strong>Results: </strong>The study cohort was composed of 2693 patients enrolled in either single-arm (n = 1517) or randomized (n = 1176) investigations of TTVI. Mean (SD) patient age was 78.6 (8.0) years, 1658 of 2693 patients (61.6%) were female, and the mean (SD) baseline KCCQ Overall Summary (KCCQ-OS) score was 50 (23). There was strong internal consistency within individual domains (Cronbach α, .77-.83). Among clinically stable patients between 1 and 6 months, there were small mean changes in KCCQ domain and summary scores (differences of -0.1 to 1.9 points), demonstrating reproducibility. In contrast, domain and summary scores of patients who underwent TTVI showed large improvements at 1 month after treatment (mean changes, 12.1-21.4 points), indicating excellent perceived responsiveness. Construct validity was moderately strong when domains were compared with best available reference measures (Spearman correlations, 0.47-0.69). In both cross-sectional and longitudinal analyses, the KCCQ-OS was associated with clinical events, with lower scores associated with an increased risk of mortality (hazard ratio, 1.34 per 10-point decrement; 95% CI, 1.22-1.47) and heart failure hospitalization (hazard ratio, 1.24 per 10-point decrement; 95% CI, 1.17-1.31).</p><p><strong>Conclusions and relevance: </strong>In this cohort study, the KCCQ had strong psychometric properties in patients with severe TR, including reliability, responsiveness, and validity. These data support use of the KCCQ in patients with severe TR as a measure of their symptoms, function, and quality of life and also for assessing the impact of i","PeriodicalId":14657,"journal":{"name":"JAMA cardiology","volume":null,"pages":null},"PeriodicalIF":14.8,"publicationDate":"2024-10-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11525660/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142545502","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
JAMA cardiologyPub Date : 2024-10-30DOI: 10.1001/jamacardio.2024.4300
Robert O Bonow, Patrick T O'Gara
{"title":"TAVR in Young Patients With Aortic Stenosis: Appropriate Use or Indication Creep?","authors":"Robert O Bonow, Patrick T O'Gara","doi":"10.1001/jamacardio.2024.4300","DOIUrl":"https://doi.org/10.1001/jamacardio.2024.4300","url":null,"abstract":"","PeriodicalId":14657,"journal":{"name":"JAMA cardiology","volume":null,"pages":null},"PeriodicalIF":14.8,"publicationDate":"2024-10-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142545501","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
JAMA cardiologyPub Date : 2024-10-30DOI: 10.1001/jamacardio.2024.4287
Eldrin F Lewis
{"title":"Measuring Health Status in Patients With Tricuspid Regurgitation.","authors":"Eldrin F Lewis","doi":"10.1001/jamacardio.2024.4287","DOIUrl":"https://doi.org/10.1001/jamacardio.2024.4287","url":null,"abstract":"","PeriodicalId":14657,"journal":{"name":"JAMA cardiology","volume":null,"pages":null},"PeriodicalIF":14.8,"publicationDate":"2024-10-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142545499","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
JAMA cardiologyPub Date : 2024-10-30DOI: 10.1001/jamacardio.2024.4237
Megan Coylewright, Kendra J Grubb, Suzanne V Arnold, Wayne Batchelor, Abhijeet Dhoble, Aaron Horne, Martin B Leon, Vinod Thourani, Tamim M Nazif, Brian R Lindman, Molly Szerlip
{"title":"Outcomes of Balloon-Expandable Transcatheter Aortic Valve Replacement in Younger Patients in the Low-Risk Era.","authors":"Megan Coylewright, Kendra J Grubb, Suzanne V Arnold, Wayne Batchelor, Abhijeet Dhoble, Aaron Horne, Martin B Leon, Vinod Thourani, Tamim M Nazif, Brian R Lindman, Molly Szerlip","doi":"10.1001/jamacardio.2024.4237","DOIUrl":"10.1001/jamacardio.2024.4237","url":null,"abstract":"<p><strong>Importance: </strong>Guidelines advise heart team assessment for all patients with aortic stenosis, with surgical aortic valve replacement recommended for patients younger than 65 years or with a life expectancy greater than 20 years. If bioprosthetic valves are selected, repeat procedures may be needed given limited durability of tissue valves; however, younger patients with aortic stenosis may have major comorbidities that can limit life expectancy, impacting decision-making.</p><p><strong>Objective: </strong>To characterize patients younger than 65 years who received transcatheter aortic valve replacement (TAVR) and compare their outcomes with patients aged 65 to 80 years.</p><p><strong>Design, setting, and participants: </strong>This retrospective registry-based analysis used data on 139 695 patients from the Society for Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy (TVT) Registry, inclusive of patients 80 years and younger undergoing TAVR from August 2019 to September 2023.</p><p><strong>Intervention: </strong>Balloon-expandable valve (BEV) TAVR with the SAPIEN family of devices.</p><p><strong>Main outcomes and measures: </strong>Comorbidities (heart failure, coronary artery disease, dialysis, and others) and outcomes (death, stroke, and hospital readmission) of patients younger than 65 years compared to patients aged 65 to 80 years.</p><p><strong>Results: </strong>In the years surveyed, 13 849 registry patients (5.7%) were younger than 65 years, 125 846 (52.1%) were aged 65 to 80 years, and 101 725 (42.1%) were 80 years and older. Among those younger than 65, the mean (SD) age was 59.7 (4.8) years, and 9068 of 13 849 patients (65.5%) were male. Among those aged 65 to 80 years, the mean (SD) age was 74.1 (4.2) years, and 77 817 of 125 843 patients (61.8%) were male. Those younger than 65 years were more likely to have a bicuspid aortic valve than those aged 65 to 80 years (3472/13 755 [25.2%] vs 9552/125 001 [7.6%], respectively; P < .001). They were more likely to have congestive heart failure, chronic lung disease, diabetes, immunocompromise, and end stage kidney disease receiving dialysis. Patients younger than 65 years had worse baseline quality of life (mean [SD] Kansas City Cardiomyopathy Questionnaire score, 47.7 [26.3] vs 52.9 [25.8], respectively; P < .001) and mean (SD) gait speed (5-meter walk test, 6.6 [5.8] seconds vs 7.0 [4.9] seconds, respectively; P < .001) than those aged 65 to 80 years. At 1 year, patients younger than 65 years had significantly higher readmission rates (2740 [28.2%] vs 23 178 [26.1%]; P < .001) and all-cause mortality (908 [9.9%] vs 6877 [8.2%]; P < .001) than older patients. When propensity matched, younger patients still had higher 1-year readmission rates (2732 [28.2%] vs 2589 [26.8%]; P < .03) with similar mortality to their older counterparts (905 [9.9%] vs 827 [10.1%]; P = .55).</p><p><strong>Conclusions and relevance: </strong>Among US patients receiving BEV","PeriodicalId":14657,"journal":{"name":"JAMA cardiology","volume":null,"pages":null},"PeriodicalIF":14.8,"publicationDate":"2024-10-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11525662/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142545500","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
JAMA cardiologyPub Date : 2024-10-29DOI: 10.1001/jamacardio.2024.4278
Raj R. Makkar, Aakriti Gupta, Thomas E. Waggoner, Samuel Horr, Juhana Karha, Lowell Satler, Robert C. Stoler, Jorge Alvarez, Rahul Sakhuja, Lee MacDonald, Rodrigo Modolo, Martin B. Leon, Axel Linke, Samir R. Kapadia
{"title":"Cerebral Embolic Protection by Geographic Region","authors":"Raj R. Makkar, Aakriti Gupta, Thomas E. Waggoner, Samuel Horr, Juhana Karha, Lowell Satler, Robert C. Stoler, Jorge Alvarez, Rahul Sakhuja, Lee MacDonald, Rodrigo Modolo, Martin B. Leon, Axel Linke, Samir R. Kapadia","doi":"10.1001/jamacardio.2024.4278","DOIUrl":"https://doi.org/10.1001/jamacardio.2024.4278","url":null,"abstract":"ImportanceTranscatheter aortic valve replacement (TAVR) is an established treatment option for many patients with severe symptomatic aortic stenosis; however, debris dislodged during the procedure can cause embolic stroke. The Sentinel cerebral embolic protection (CEP) device is approved for capture and removal of embolic material during TAVR but its efficacy has been debated.ObjectiveTo explore regional differences in the association of CEP utilization with stroke outcomes in patients undergoing TAVR.Design, Setting, and ParticipantsThis post hoc analysis of a prospective, postmarket, randomized clinical trial evaluating TAVR performed with or without the CEP took place at 51 hospitals in the US, Europe, and Australia from February 2020 to January 2022. Patients with symptomatic aortic stenosis treated with transfemoral TAVR were included. Randomization was stratified according to center, operative risk, and intended TAVR valve type. Patients were excluded if the left common carotid or brachiocephalic artery had greater than 70% stenosis or if the anatomy precluded placement of the CEP device. Data for this post hoc study were analyzed from August to October 2024.InterventionTAVR with or without CEP.Main Outcomes and MeasuresThe primary end point was the rate of all stroke events at hospital discharge or 72 hours post-TAVR, whichever came first. Neurological examinations were performed at baseline and postprocedure to identify stroke, disabling stroke, and other neurological outcomes.ResultsThe Stroke Protection With Sentinel During Transcatheter Aortic Valve Replacement (PROTECTED TAVR) trial enrolled and randomized 3000 patients (1803 [60.1%] male; mean [SD] age, 78.9 [7.8] years): 1833 in the US cohort (TAVR alone: 919, TAVR with CEP: 914) and 1167 patients in the outside the US (OUS) cohort (TAVR alone: 580, TAVR with CEP: 587). Patients in the US cohort were younger, more predominantly male, had a lower prevalence of atrial fibrillation, and had a higher prevalence of bicuspid aortic valve, diabetes, and peripheral vascular disease compared with the OUS cohort. In the main trial, the incidence of stroke within 72 hours after TAVR or before discharge did not differ significantly between the CEP group and the control group, and there was no interaction by geographic region. In this post hoc analysis, patients treated with CEP in the US cohort exhibited a 50% relative risk reduction for overall stroke and a 73% relative risk reduction for disabling stroke compared to TAVR alone; a treatment effect on stroke risk reduction was not observed in the OUS cohort.Conclusion and RelevanceThe PROTECTED TAVR trial could not show that the use of CEP had a significant effect on the incidence of periprocedural stroke during TAVR. Although there was no significant interaction by geographic region, this exploratory post hoc analysis suggests a trend toward greater stroke reduction in the US cohort but not in the OUS cohort. These findings are hypothesis gene","PeriodicalId":14657,"journal":{"name":"JAMA cardiology","volume":null,"pages":null},"PeriodicalIF":24.0,"publicationDate":"2024-10-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142541161","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}