M. Madan, J. Abbott, R. Lennon, D. So, Andrea M MacDougall, M. McLaughlin, V. Murthy, J. Saw, C. Rihal, M. Farkouh, N. Pereira, S. Goodman
Background TAILOR‐PCI (Tailored Antiplatelet Initiation to Lessen Outcomes due to decreased Clopidogrel Response After Percutaneous Coronary Intervention) studied genotype‐guided selection of antiplatelet therapy after percutaneous coronary intervention versus conventional therapy with clopidogrel. The presence of CYP2C19 loss‐of‐function alleles in patients treated with clopidogrel may be associated with increased risk for ischemic events. We report a prespecified sex‐specific analysis of genotyping and associated cardiovascular outcomes from this study. Methods and Results Associations between sex and major adverse cardiac events (MACE: cardiovascular death, myocardial infarction, stroke, stent thrombosis, and severe recurrent ischemia) and Bleeding Academic Research Consortium (BARC) bleeding at 12 months were analyzed using Cox proportional‐hazards models. Among 5276 randomized patients, loss‐of‐function carriers were observed in ≈36% of both sexes, and >80% of carriers were heterozygotes. At 12 months, after adjustment for baseline differences, risks of MACE (HR , 1.28 [0.97 to 1.68]; P=0.088) and BARC bleeding (hazard ratio [HR], 1.36 [0.91 to 2.05]; P=0.14) were comparable among women and men. There were no significant interactions between sex and treatment strategy for MACE interaction P value (Pint =0.59) or BARC bleeding (P int=0.47) nor for sex and genotype (MACE P int=0.15, and BARC bleeding P int=0.60). Conclusions CYP2C19 loss‐of‐function alleles were present in ≈1 in 3 women and men. Women had similar adjusted risks of MACE and bleeding as men following percutaneous coronary intervention. Genotype‐guided therapy did not significantly reduce the risk of MACE or bleeding relative to conventional therapy for both sexes. Registration URL: https://www.clinicaltrials.gov; Unique identifier: NCT01742117.
{"title":"Sex‐Specific Differences in Clinical Outcomes After Percutaneous Coronary Intervention: Insights from the TAILOR‐PCI Trial","authors":"M. Madan, J. Abbott, R. Lennon, D. So, Andrea M MacDougall, M. McLaughlin, V. Murthy, J. Saw, C. Rihal, M. Farkouh, N. Pereira, S. Goodman","doi":"10.1161/JAHA.121.024709","DOIUrl":"https://doi.org/10.1161/JAHA.121.024709","url":null,"abstract":"Background TAILOR‐PCI (Tailored Antiplatelet Initiation to Lessen Outcomes due to decreased Clopidogrel Response After Percutaneous Coronary Intervention) studied genotype‐guided selection of antiplatelet therapy after percutaneous coronary intervention versus conventional therapy with clopidogrel. The presence of CYP2C19 loss‐of‐function alleles in patients treated with clopidogrel may be associated with increased risk for ischemic events. We report a prespecified sex‐specific analysis of genotyping and associated cardiovascular outcomes from this study. Methods and Results Associations between sex and major adverse cardiac events (MACE: cardiovascular death, myocardial infarction, stroke, stent thrombosis, and severe recurrent ischemia) and Bleeding Academic Research Consortium (BARC) bleeding at 12 months were analyzed using Cox proportional‐hazards models. Among 5276 randomized patients, loss‐of‐function carriers were observed in ≈36% of both sexes, and >80% of carriers were heterozygotes. At 12 months, after adjustment for baseline differences, risks of MACE (HR , 1.28 [0.97 to 1.68]; P=0.088) and BARC bleeding (hazard ratio [HR], 1.36 [0.91 to 2.05]; P=0.14) were comparable among women and men. There were no significant interactions between sex and treatment strategy for MACE interaction P value (Pint =0.59) or BARC bleeding (P int=0.47) nor for sex and genotype (MACE P int=0.15, and BARC bleeding P int=0.60). Conclusions CYP2C19 loss‐of‐function alleles were present in ≈1 in 3 women and men. Women had similar adjusted risks of MACE and bleeding as men following percutaneous coronary intervention. Genotype‐guided therapy did not significantly reduce the risk of MACE or bleeding relative to conventional therapy for both sexes. Registration URL: https://www.clinicaltrials.gov; Unique identifier: NCT01742117.","PeriodicalId":17189,"journal":{"name":"Journal of the American Heart Association: Cardiovascular and Cerebrovascular Disease","volume":"32 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2022-06-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"84847529","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Monique M. Gardner, G. Keim, J. Hsia, A. Mai, J. William Gaynor, Andrew C. Glatz, N. Yehya
Background Neonates with heart disease requiring cardiopulmonary bypass surgery are at high risk for mortality and morbidity. As it is rare, short‐term mortality is difficult to use as a primary outcome for clinical studies. We proposed “ICU‐30” as a binary composite “poor” outcome consisting of: (1) mortality within 30 days, (2) intensive care unit (ICU) admission ≥30 days, or (3) ICU readmission before day 30. To measure the utility of this composite, we assessed its prognostic properties for 6‐ and 12‐month mortality. Methods and Results This was a retrospective single‐center cohort study of neonates requiring cardiopulmonary bypass between 2013 and 2020. Mortality among patients with and without the ICU‐30 outcome was compared using log‐rank tests and Cox regression. Areas under the receiver operating characteristic curves assessed the ability of the composite to predict 12‐month mortality. In 887 neonates, 232 (26.2%) experienced the ICU‐30 outcome, with more prolonged ICU stays and readmissions (both ≥9%) than 30‐day mortality (4.2%). ICU‐30 was associated with higher rates of 6‐ and 12‐month mortality (log‐rank P<0.001) and predicted 12‐month mortality with area under the receiver operating characteristic of 0.81 (95% CI, 0.77–0.85). In 30‐day survivors, both prolonged ICU stay (hazard ratio, 12.3; 95% CI, 6.70–22.7; P<0.001) and ICU readmission (hazard ratio, 2.99; 95% CI, 1.17–7.63; P=0.02) were associated with 12‐month mortality. Conclusions ICU‐30, a composite outcome of mortality, ICU length of stay, or ICU readmission by 30 days was associated with 6‐ and 12‐month mortality in neonates requiring cardiopulmonary bypass. ICU‐30 is captured in routine data collection and appears to be a valid binary patient‐centered outcome.
{"title":"Characterization of “ICU‐30”: A Binary Composite Outcome for Neonates With Critical Congenital Heart Disease","authors":"Monique M. Gardner, G. Keim, J. Hsia, A. Mai, J. William Gaynor, Andrew C. Glatz, N. Yehya","doi":"10.1161/JAHA.122.025494","DOIUrl":"https://doi.org/10.1161/JAHA.122.025494","url":null,"abstract":"Background Neonates with heart disease requiring cardiopulmonary bypass surgery are at high risk for mortality and morbidity. As it is rare, short‐term mortality is difficult to use as a primary outcome for clinical studies. We proposed “ICU‐30” as a binary composite “poor” outcome consisting of: (1) mortality within 30 days, (2) intensive care unit (ICU) admission ≥30 days, or (3) ICU readmission before day 30. To measure the utility of this composite, we assessed its prognostic properties for 6‐ and 12‐month mortality. Methods and Results This was a retrospective single‐center cohort study of neonates requiring cardiopulmonary bypass between 2013 and 2020. Mortality among patients with and without the ICU‐30 outcome was compared using log‐rank tests and Cox regression. Areas under the receiver operating characteristic curves assessed the ability of the composite to predict 12‐month mortality. In 887 neonates, 232 (26.2%) experienced the ICU‐30 outcome, with more prolonged ICU stays and readmissions (both ≥9%) than 30‐day mortality (4.2%). ICU‐30 was associated with higher rates of 6‐ and 12‐month mortality (log‐rank P<0.001) and predicted 12‐month mortality with area under the receiver operating characteristic of 0.81 (95% CI, 0.77–0.85). In 30‐day survivors, both prolonged ICU stay (hazard ratio, 12.3; 95% CI, 6.70–22.7; P<0.001) and ICU readmission (hazard ratio, 2.99; 95% CI, 1.17–7.63; P=0.02) were associated with 12‐month mortality. Conclusions ICU‐30, a composite outcome of mortality, ICU length of stay, or ICU readmission by 30 days was associated with 6‐ and 12‐month mortality in neonates requiring cardiopulmonary bypass. ICU‐30 is captured in routine data collection and appears to be a valid binary patient‐centered outcome.","PeriodicalId":17189,"journal":{"name":"Journal of the American Heart Association: Cardiovascular and Cerebrovascular Disease","volume":"51 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2022-06-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"85391835","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Jun Wan, Shao-bin Lin, Zhuli Yu, Z. Song, Xuefeng Lin, Rongning Xu, Songlin Du
Background Extracellular vesicles (EVs) are a popular treatment candidate for myocardial injury. This work investigated the effects of mesenchymal stem cells (MSCs)–secreted EVs–derived miR‐200b‐3p on cardiomyocyte apoptosis and inflammatory response after myocardial infarction (MI) through targeting BCL2L11 (Bcl‐2–like protein 11) . Methods and Results EVs from MSCs were isolated and identified. EVs from MSCs with transfection of miR‐200b‐3p for overexpression were injected into MI mice. The effect of miR‐200b‐3p on cardiac function, infarction area, myocardial fibrosis, cardiomyocyte apoptosis, and inflammatory response was determined in MI mice. The targeting relationship between miR‐200b‐3p and BCL2L11 was verified, and the interaction between BCL2L11 and NLR family pyrin domain containing 1 (NLRP1) was also verified. MI mice were injected with an overexpressing BCL2L11 lentiviral vector to clarify whether BCL2L11 can regulate the effect of miR‐200b‐3p on MI mice. EVs from MSCs were successfully extracted. MSCs‐EVs improved cardiac function and reduced infarction area, apoptosis of cardiomyocytes, myocardial fibrosis, and inflammation in MI mice. Upregulation of miR‐200b‐3p further enhanced the effects of MSCs‐EVs on the myocardial injury of MI mice. BCL2L11 was targeted by miR‐200b‐3p and bound to NLRP1. Upregulation of BCL2L11 negated the role of miR‐200b‐3p–modified MSCs‐EVs in MI mice. Conclusions A summary was obtained that miR‐200b‐3p–encapsulated MSCs‐EVs protect against MI‐induced apoptosis of cardiomyocytes and inflammation via suppressing BCL2L11.
{"title":"Protective Effects of MicroRNA‐200b‐3p Encapsulated by Mesenchymal Stem Cells–Secreted Extracellular Vesicles in Myocardial Infarction Via Regulating BCL2L11","authors":"Jun Wan, Shao-bin Lin, Zhuli Yu, Z. Song, Xuefeng Lin, Rongning Xu, Songlin Du","doi":"10.1161/JAHA.121.024330","DOIUrl":"https://doi.org/10.1161/JAHA.121.024330","url":null,"abstract":"Background Extracellular vesicles (EVs) are a popular treatment candidate for myocardial injury. This work investigated the effects of mesenchymal stem cells (MSCs)–secreted EVs–derived miR‐200b‐3p on cardiomyocyte apoptosis and inflammatory response after myocardial infarction (MI) through targeting BCL2L11 (Bcl‐2–like protein 11) . Methods and Results EVs from MSCs were isolated and identified. EVs from MSCs with transfection of miR‐200b‐3p for overexpression were injected into MI mice. The effect of miR‐200b‐3p on cardiac function, infarction area, myocardial fibrosis, cardiomyocyte apoptosis, and inflammatory response was determined in MI mice. The targeting relationship between miR‐200b‐3p and BCL2L11 was verified, and the interaction between BCL2L11 and NLR family pyrin domain containing 1 (NLRP1) was also verified. MI mice were injected with an overexpressing BCL2L11 lentiviral vector to clarify whether BCL2L11 can regulate the effect of miR‐200b‐3p on MI mice. EVs from MSCs were successfully extracted. MSCs‐EVs improved cardiac function and reduced infarction area, apoptosis of cardiomyocytes, myocardial fibrosis, and inflammation in MI mice. Upregulation of miR‐200b‐3p further enhanced the effects of MSCs‐EVs on the myocardial injury of MI mice. BCL2L11 was targeted by miR‐200b‐3p and bound to NLRP1. Upregulation of BCL2L11 negated the role of miR‐200b‐3p–modified MSCs‐EVs in MI mice. Conclusions A summary was obtained that miR‐200b‐3p–encapsulated MSCs‐EVs protect against MI‐induced apoptosis of cardiomyocytes and inflammation via suppressing BCL2L11.","PeriodicalId":17189,"journal":{"name":"Journal of the American Heart Association: Cardiovascular and Cerebrovascular Disease","volume":"48 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2022-06-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"79136178","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Jiali Yao, Nicole Lim, Jeremy Tan, Andre Matthias Müller, Rob Martinus van Dam, Cynthia Chen, C. Tan, F. Müller-Riemenschneider
Background Evidence of scaled‐up physical activity interventions is scarce. This study evaluates the uptake, engagement, and effectiveness of one such intervention program. Methods and Results The program was open to individuals aged ≥17 years in Singapore. The main intervention components comprised device‐based daily physical activity recording paired with step count goals and financial rewards. According to the different reward opportunities, we divided the evaluation period (August 2017 to June 2018) into the baseline monitoring phase, the main challenge phase, and the maintenance phase. Uptake was assessed by the number of individuals registered, and engagement by the step recording duration after registration. The effectiveness was defined as changes in mean daily step count from baseline to the main challenge phase and the maintenance phase. A total of 696 907 participants registered, including more Singapore citizens (versus noncitizens), women, and younger (aged 17–39 years) individuals. The evaluation of engagement and effectiveness included 421 388 (60.5%) participants who provided plausible characteristic information and step count data. The median duration of engagement was 74 (IQR, 14–149) days. Compared with the baseline of 7509 (SD, 3467) steps, mean daily step count increased by 1579 (95% CI, 1564–1594) steps during the main challenge phase and 934 (95% CI, 916–952) steps during the maintenance phase. Greater engagement and activity increase were found in participants who are citizens, women, aged ≥40 years, non‐obese, and using separate wearables (versus smartphones). Conclusions Mobile health physical activity interventions can successfully reach a large population and be effective in increasing physical activity, despite declining program engagement over time.
{"title":"Evaluation of a Population‐Wide Mobile Health Physical Activity Program in 696 907 Adults in Singapore","authors":"Jiali Yao, Nicole Lim, Jeremy Tan, Andre Matthias Müller, Rob Martinus van Dam, Cynthia Chen, C. Tan, F. Müller-Riemenschneider","doi":"10.1161/JAHA.121.022508","DOIUrl":"https://doi.org/10.1161/JAHA.121.022508","url":null,"abstract":"Background Evidence of scaled‐up physical activity interventions is scarce. This study evaluates the uptake, engagement, and effectiveness of one such intervention program. Methods and Results The program was open to individuals aged ≥17 years in Singapore. The main intervention components comprised device‐based daily physical activity recording paired with step count goals and financial rewards. According to the different reward opportunities, we divided the evaluation period (August 2017 to June 2018) into the baseline monitoring phase, the main challenge phase, and the maintenance phase. Uptake was assessed by the number of individuals registered, and engagement by the step recording duration after registration. The effectiveness was defined as changes in mean daily step count from baseline to the main challenge phase and the maintenance phase. A total of 696 907 participants registered, including more Singapore citizens (versus noncitizens), women, and younger (aged 17–39 years) individuals. The evaluation of engagement and effectiveness included 421 388 (60.5%) participants who provided plausible characteristic information and step count data. The median duration of engagement was 74 (IQR, 14–149) days. Compared with the baseline of 7509 (SD, 3467) steps, mean daily step count increased by 1579 (95% CI, 1564–1594) steps during the main challenge phase and 934 (95% CI, 916–952) steps during the maintenance phase. Greater engagement and activity increase were found in participants who are citizens, women, aged ≥40 years, non‐obese, and using separate wearables (versus smartphones). Conclusions Mobile health physical activity interventions can successfully reach a large population and be effective in increasing physical activity, despite declining program engagement over time.","PeriodicalId":17189,"journal":{"name":"Journal of the American Heart Association: Cardiovascular and Cerebrovascular Disease","volume":"123 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2022-06-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"75802716","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Edward T O'Leary, Jamie Harris, K. Gauvreau, Courtney Gentry, A. Dionne, D. Abrams, M. Alexander, Vassilios J. Bezzerides, E. DeWitt, J. Triedman, E. Walsh, D. Mah
Background Catheter‐based slow‐pathway modification (SPM) is the treatment of choice for symptomatic atrioventricular nodal reentrant tachycardia (AVNRT). We sought to investigate the interactions between patient age and procedural outcomes in pediatric patients undergoing catheter‐based SPM for AVNRT. Methods and Results A retrospective cohort study was performed, including consecutive patients undergoing acutely successful SPM for AVNRT from 2008 to 2017. Those with congenital heart disease, cardiomyopathy, and accessory pathways were excluded. Patients were stratified by age quartile at time of SPM. The primary outcome was AVNRT recurrence. A total of 512 patients underwent successful SPM for AVNRT. Age quartile 1 had 129 patients with a median age and weight of 8.9 years and 30.6 kg, respectively. Radiofrequency energy was used in 98% of cases. Follow‐up was available in 447 (87%) patients with a median duration of 0.8 years (interquartile range, 0.2–2.5 years). AVNRT recurred in 22 patients. Multivariable Cox proportional hazard modeling identified atypical AVNRT (hazard ratio [HR], 5.83; 95% CI, 2.01–16.96; P=0.001), dual atrioventricular nodal only (HR, 4.09; 95% CI, 1.39–12.02; P=0.011), total radiofrequency lesions (HR, 1.06 per lesion; 95% CI, 1.01–1.12; P=0.032), and the use of a long sheath (HR, 3.52; 95% CI, 1.23–10.03; P=0.010) as predictors of AVNRT recurrence; quartile 1 patients were not at higher risk of recurrence (HR, 0.45; 95% CI, 0.10–1.97; P=0.29). Complete heart block requiring permanent pacing occurred in one quartile 2 patient at 14.9 years of age. Conclusions Pediatric AVNRT can be treated with radiofrequency‐SPM with high procedural efficacy and minimal risk of complications, including heart block. Atypical AVNRT and dual atrioventricular nodal physiology without inducible tachycardia remain challenging substrates.
{"title":"Radiofrequency Catheter Ablation for Pediatric Atrioventricular Nodal Reentrant Tachycardia: Impact of Age on Procedural Methods and Durable Success","authors":"Edward T O'Leary, Jamie Harris, K. Gauvreau, Courtney Gentry, A. Dionne, D. Abrams, M. Alexander, Vassilios J. Bezzerides, E. DeWitt, J. Triedman, E. Walsh, D. Mah","doi":"10.1161/JAHA.121.022799","DOIUrl":"https://doi.org/10.1161/JAHA.121.022799","url":null,"abstract":"Background Catheter‐based slow‐pathway modification (SPM) is the treatment of choice for symptomatic atrioventricular nodal reentrant tachycardia (AVNRT). We sought to investigate the interactions between patient age and procedural outcomes in pediatric patients undergoing catheter‐based SPM for AVNRT. Methods and Results A retrospective cohort study was performed, including consecutive patients undergoing acutely successful SPM for AVNRT from 2008 to 2017. Those with congenital heart disease, cardiomyopathy, and accessory pathways were excluded. Patients were stratified by age quartile at time of SPM. The primary outcome was AVNRT recurrence. A total of 512 patients underwent successful SPM for AVNRT. Age quartile 1 had 129 patients with a median age and weight of 8.9 years and 30.6 kg, respectively. Radiofrequency energy was used in 98% of cases. Follow‐up was available in 447 (87%) patients with a median duration of 0.8 years (interquartile range, 0.2–2.5 years). AVNRT recurred in 22 patients. Multivariable Cox proportional hazard modeling identified atypical AVNRT (hazard ratio [HR], 5.83; 95% CI, 2.01–16.96; P=0.001), dual atrioventricular nodal only (HR, 4.09; 95% CI, 1.39–12.02; P=0.011), total radiofrequency lesions (HR, 1.06 per lesion; 95% CI, 1.01–1.12; P=0.032), and the use of a long sheath (HR, 3.52; 95% CI, 1.23–10.03; P=0.010) as predictors of AVNRT recurrence; quartile 1 patients were not at higher risk of recurrence (HR, 0.45; 95% CI, 0.10–1.97; P=0.29). Complete heart block requiring permanent pacing occurred in one quartile 2 patient at 14.9 years of age. Conclusions Pediatric AVNRT can be treated with radiofrequency‐SPM with high procedural efficacy and minimal risk of complications, including heart block. Atypical AVNRT and dual atrioventricular nodal physiology without inducible tachycardia remain challenging substrates.","PeriodicalId":17189,"journal":{"name":"Journal of the American Heart Association: Cardiovascular and Cerebrovascular Disease","volume":"131 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2022-06-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"86349020","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Tadao Aikawa, T. Kuno, J. Van den Eynde, A. Briasoulis, Aaqib H. Malik
he development of novel devices and the favorable results of several randomized clinical trials have allowed for the rapid expansion of transcatheter aortic valve implantation (TAVI) to elderly patients with aortic stenosis across all risk categories 1 ; however, the highly selected populations that are typically enrolled in randomized clinical trials may limit generalizability of the results to the real- world population with aortic stenosis. Furthermore, clinical trial or research program participation itself can facilitate behavior change in patients and health care providers and may contribute to improved patient outcomes, which is known as the “Hawthorne effect.” 2 Previous studies reported that research participation was associated with better survival in patients with acute coronary syndrome. 3,4 Given the lack of data exploring the effect of research participation on outcomes after TAVI, we compared the short- term survival after TAVI between clinical research participants and nonparticipants using the Nationwide Inpatient Sample. The data that support the findings of this study are available from the corresponding author upon rea-sonable request. The Nationwide Inpatient Sample is the largest publicly available all- payer inpatient health care database in the United States and did not require ethical approval. All patients who underwent TAVI between 2013 and 2019 (n=56 648) were identified from the Nationwide Inpatient Sample using the following International Classification of Diseases, Tenth Revision, Clinical Modification (ICD- 10- CM) codes: 02RF37H, 02RF37Z, 02RF38H, 02RF38Z, 02RF3JH, 02RF3JZ, 02RF3KH, and 02RF3KZ. Patients with age ≤18 years (n=22), cirrhosis (n=760), end- stage renal disease (n=2136), do- not- resuscitate status or palliative care in-volvement (n=383), and cancer (n=1952) were excluded with reference to previous trials. Patients with missing data (n=12) were also excluded. Research participation status was identified using ICD- 10- CM code Z00.6, 4 which was restricted to code as the primary diagnosis or first secondary diagnosis to avoid overcapturing. The hospital research participation
{"title":"Effects of Clinical Trial or Research Program Participation Status on In‐Hospital Mortality After Transcatheter Aortic Valve Implantation","authors":"Tadao Aikawa, T. Kuno, J. Van den Eynde, A. Briasoulis, Aaqib H. Malik","doi":"10.1161/JAHA.121.025920","DOIUrl":"https://doi.org/10.1161/JAHA.121.025920","url":null,"abstract":"he development of novel devices and the favorable results of several randomized clinical trials have allowed for the rapid expansion of transcatheter aortic valve implantation (TAVI) to elderly patients with aortic stenosis across all risk categories 1 ; however, the highly selected populations that are typically enrolled in randomized clinical trials may limit generalizability of the results to the real- world population with aortic stenosis. Furthermore, clinical trial or research program participation itself can facilitate behavior change in patients and health care providers and may contribute to improved patient outcomes, which is known as the “Hawthorne effect.” 2 Previous studies reported that research participation was associated with better survival in patients with acute coronary syndrome. 3,4 Given the lack of data exploring the effect of research participation on outcomes after TAVI, we compared the short- term survival after TAVI between clinical research participants and nonparticipants using the Nationwide Inpatient Sample. The data that support the findings of this study are available from the corresponding author upon rea-sonable request. The Nationwide Inpatient Sample is the largest publicly available all- payer inpatient health care database in the United States and did not require ethical approval. All patients who underwent TAVI between 2013 and 2019 (n=56 648) were identified from the Nationwide Inpatient Sample using the following International Classification of Diseases, Tenth Revision, Clinical Modification (ICD- 10- CM) codes: 02RF37H, 02RF37Z, 02RF38H, 02RF38Z, 02RF3JH, 02RF3JZ, 02RF3KH, and 02RF3KZ. Patients with age ≤18 years (n=22), cirrhosis (n=760), end- stage renal disease (n=2136), do- not- resuscitate status or palliative care in-volvement (n=383), and cancer (n=1952) were excluded with reference to previous trials. Patients with missing data (n=12) were also excluded. Research participation status was identified using ICD- 10- CM code Z00.6, 4 which was restricted to code as the primary diagnosis or first secondary diagnosis to avoid overcapturing. The hospital research participation","PeriodicalId":17189,"journal":{"name":"Journal of the American Heart Association: Cardiovascular and Cerebrovascular Disease","volume":"6 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2022-06-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"89555143","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
D. Mujwara, G. Henno, S. Vernon, S. Peng, P. Di Domenico, B. Schroeder, G. Busby, G. Figtree, G. Bottà
Background Cardiovascular diseases are the leading cause of death in the United States, yet a significant proportion of adults at high risk remain undetected by standard screening practices. Polygenic risk score for coronary artery disease (CAD‐PRS) improves precision in determining the 10‐year risk of atherosclerotic cardiovascular disease but health benefits and health care costs associated with CAD‐PRS are unknown. We examined the cost‐effectiveness of including CAD‐PRS as a risk‐enhancing factor in the pooled cohort equation (PCE)—the standard of care for determining the risk of atherosclerotic cardiovascular disease—versus PCE alone. Methods and Results We applied a Markov model on a cohort of 40‐year‐old individuals with borderline or intermediate 10‐year risk (5% to <20%) for atherosclerotic cardiovascular disease to identify those in the top quintile of the CAD‐PRS distribution who are at high risk and eligible for statin prevention therapy. Health outcomes examined included coronary artery disease (CAD; ie, myocardial infarction) and ischemic stroke. The model projected medical costs (2019 US$) of screening for CAD, statin prevention therapy, treatment, and monitoring patients living with CAD or ischemic stroke and quality‐adjusted life‐years for PCE+CAD‐PRS versus PCE alone. Deterministic and probabilistic sensitivity analyses and scenario analyses were performed to examine uncertainty in parameter inputs. PCE+CAD‐PRS was dominant compared with PCE alone in the 5‐ and 10‐year time horizons. We found that, respectively, PCE+CAD‐PRS had 0.003 and 0.011 higher mean quality‐adjusted life‐years and $40 and $181 lower mean costs per person screened, with 29 and 50 fewer events of CAD and ischemic stroke in a cohort of 10 000 individuals compared with PCE alone. The risk of developing CAD, the effectiveness of statin prevention therapy, and the cost of treating CAD had the largest impact on the cost per quality‐adjusted life‐year gained. However, this cost remained below the $50 000 willingness‐to‐pay threshold except when the annual risk of developing CAD was <0.006 in the 5‐year time horizon. Results from Monte Carlo simulation indicated that PCE+CAD‐PRS would be cost‐effective. with the probability of 94% and 99% at $50 000 willingness‐to‐pay threshold in the 5‐ and 10‐year time horizon, respectively. Conclusions Implementing CAD‐PRS as a risk‐enhancing factor in the PCE to determine the risk of atherosclerotic cardiovascular disease reduced the mean cost per individual, improved quality‐adjusted life‐years, and averted future events of CAD and ischemic stroke when compared with PCE alone.
{"title":"Integrating a Polygenic Risk Score for Coronary Artery Disease as a Risk‐Enhancing Factor in the Pooled Cohort Equation: A Cost‐Effectiveness Analysis Study","authors":"D. Mujwara, G. Henno, S. Vernon, S. Peng, P. Di Domenico, B. Schroeder, G. Busby, G. Figtree, G. Bottà","doi":"10.1161/JAHA.121.025236","DOIUrl":"https://doi.org/10.1161/JAHA.121.025236","url":null,"abstract":"Background Cardiovascular diseases are the leading cause of death in the United States, yet a significant proportion of adults at high risk remain undetected by standard screening practices. Polygenic risk score for coronary artery disease (CAD‐PRS) improves precision in determining the 10‐year risk of atherosclerotic cardiovascular disease but health benefits and health care costs associated with CAD‐PRS are unknown. We examined the cost‐effectiveness of including CAD‐PRS as a risk‐enhancing factor in the pooled cohort equation (PCE)—the standard of care for determining the risk of atherosclerotic cardiovascular disease—versus PCE alone. Methods and Results We applied a Markov model on a cohort of 40‐year‐old individuals with borderline or intermediate 10‐year risk (5% to <20%) for atherosclerotic cardiovascular disease to identify those in the top quintile of the CAD‐PRS distribution who are at high risk and eligible for statin prevention therapy. Health outcomes examined included coronary artery disease (CAD; ie, myocardial infarction) and ischemic stroke. The model projected medical costs (2019 US$) of screening for CAD, statin prevention therapy, treatment, and monitoring patients living with CAD or ischemic stroke and quality‐adjusted life‐years for PCE+CAD‐PRS versus PCE alone. Deterministic and probabilistic sensitivity analyses and scenario analyses were performed to examine uncertainty in parameter inputs. PCE+CAD‐PRS was dominant compared with PCE alone in the 5‐ and 10‐year time horizons. We found that, respectively, PCE+CAD‐PRS had 0.003 and 0.011 higher mean quality‐adjusted life‐years and $40 and $181 lower mean costs per person screened, with 29 and 50 fewer events of CAD and ischemic stroke in a cohort of 10 000 individuals compared with PCE alone. The risk of developing CAD, the effectiveness of statin prevention therapy, and the cost of treating CAD had the largest impact on the cost per quality‐adjusted life‐year gained. However, this cost remained below the $50 000 willingness‐to‐pay threshold except when the annual risk of developing CAD was <0.006 in the 5‐year time horizon. Results from Monte Carlo simulation indicated that PCE+CAD‐PRS would be cost‐effective. with the probability of 94% and 99% at $50 000 willingness‐to‐pay threshold in the 5‐ and 10‐year time horizon, respectively. Conclusions Implementing CAD‐PRS as a risk‐enhancing factor in the PCE to determine the risk of atherosclerotic cardiovascular disease reduced the mean cost per individual, improved quality‐adjusted life‐years, and averted future events of CAD and ischemic stroke when compared with PCE alone.","PeriodicalId":17189,"journal":{"name":"Journal of the American Heart Association: Cardiovascular and Cerebrovascular Disease","volume":"3 6","pages":""},"PeriodicalIF":0.0,"publicationDate":"2022-06-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"91485523","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
K. Stanton, V. Kienzle, D. Dinnes, Irina Kotchetkov, W. Jessup, L. Kritharides, D. Celermajer, K. Rye
Background Exercise is associated with a reduced risk of cardiovascular disease. Increased high‐density lipoprotein cholesterol (HDL‐C) levels are thought to contribute to these benefits, but much of the research in this area has been limited by lack of well‐controlled subject selection and exercise interventions. We sought to study the effect of moderate and high‐intensity exercise on HDL function, lipid/lipoprotein profile, and other cardiometabolic parameters in a homogeneous population where exercise, daily routine, sleep patterns, and living conditions were carefully controlled. Methods and Results Male Army recruits (n=115, age 22±0.3 years) completed a 12‐week moderate‐intensity exercise program. A subset of 51 subsequently completed a 15‐week high‐intensity exercise program. Fitness increased and body fat decreased after moderate‐ and high‐intensity exercise (P<0.001). Moderate‐intensity exercise increased HDL‐C and apolipoprotein A‐I levels (6.6%, 11.6% respectively), and decreased low‐density lipoprotein cholesterol and apolipoprotein B levels (7.2%, 4.9% respectively) (all P<0.01). HDL‐C and apolipoprotein A‐I levels further increased by 8.2% (P<0.001) and 6.3% (P<0.05) after high‐intensity exercise. Moderate‐intensity exercise increased ABCA‐1 (ATP‐binding cassette transporter A1) mediated cholesterol efflux by 13.5% (P<0.001), which was sustained after high‐intensity exercise. In a selected subset the ability of HDLs to inhibit ICAM‐1 (intercellular adhesion molecule‐1) expression decreased after the high (P<0.001) but not the moderate‐intensity exercise program. Conclusions When controlling for exercise patterns, diet, and sleep, moderate‐intensity exercise improved HDL function, lipid/lipoprotein profile, fitness, and body composition. A sequential moderate followed by high‐intensity exercise program showed sustained or incremental benefits in these parameters. Improved HDL function may be part of the mechanism by which exercise reduces cardiovascular disease risk.
{"title":"Moderate‐ and High‐Intensity Exercise Improves Lipoprotein Profile and Cholesterol Efflux Capacity in Healthy Young Men","authors":"K. Stanton, V. Kienzle, D. Dinnes, Irina Kotchetkov, W. Jessup, L. Kritharides, D. Celermajer, K. Rye","doi":"10.1161/JAHA.121.023386","DOIUrl":"https://doi.org/10.1161/JAHA.121.023386","url":null,"abstract":"Background Exercise is associated with a reduced risk of cardiovascular disease. Increased high‐density lipoprotein cholesterol (HDL‐C) levels are thought to contribute to these benefits, but much of the research in this area has been limited by lack of well‐controlled subject selection and exercise interventions. We sought to study the effect of moderate and high‐intensity exercise on HDL function, lipid/lipoprotein profile, and other cardiometabolic parameters in a homogeneous population where exercise, daily routine, sleep patterns, and living conditions were carefully controlled. Methods and Results Male Army recruits (n=115, age 22±0.3 years) completed a 12‐week moderate‐intensity exercise program. A subset of 51 subsequently completed a 15‐week high‐intensity exercise program. Fitness increased and body fat decreased after moderate‐ and high‐intensity exercise (P<0.001). Moderate‐intensity exercise increased HDL‐C and apolipoprotein A‐I levels (6.6%, 11.6% respectively), and decreased low‐density lipoprotein cholesterol and apolipoprotein B levels (7.2%, 4.9% respectively) (all P<0.01). HDL‐C and apolipoprotein A‐I levels further increased by 8.2% (P<0.001) and 6.3% (P<0.05) after high‐intensity exercise. Moderate‐intensity exercise increased ABCA‐1 (ATP‐binding cassette transporter A1) mediated cholesterol efflux by 13.5% (P<0.001), which was sustained after high‐intensity exercise. In a selected subset the ability of HDLs to inhibit ICAM‐1 (intercellular adhesion molecule‐1) expression decreased after the high (P<0.001) but not the moderate‐intensity exercise program. Conclusions When controlling for exercise patterns, diet, and sleep, moderate‐intensity exercise improved HDL function, lipid/lipoprotein profile, fitness, and body composition. A sequential moderate followed by high‐intensity exercise program showed sustained or incremental benefits in these parameters. Improved HDL function may be part of the mechanism by which exercise reduces cardiovascular disease risk.","PeriodicalId":17189,"journal":{"name":"Journal of the American Heart Association: Cardiovascular and Cerebrovascular Disease","volume":"42 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2022-06-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"89947106","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
R. Emoto, M. Nishikimi, M. Shoaib, Kei Hayashida, Kazuki Nishida, K. Kikutani, S. Ohshimo, S. Matsui, N. Shime, T. Iwami
Background Predicting a spontaneous rhythm change from nonshockable to shockable before hospital arrival in patients with out‐of‐hospital cardiac arrest can help emergency medical services develop better strategies for prehospital treatment. The aim of this study was to identify predictors of spontaneous rhythm change before hospital arrival in patients with out‐of‐hospital cardiac arrest and develop a predictive scoring system. Methods and Results We retrospectively reviewed data of eligible patients with out‐of‐hospital cardiac arrest with an initial nonshockable rhythm registered in a nationwide registry between June 2014 and December 2017. We performed a multivariable analysis using a Cox proportional hazards model to identify predictors of a spontaneous rhythm change, and a ridge regression model for predicting it. The data of 25 804 patients were analyzed (derivation cohort, n=17 743; validation cohort, n=8061). The rhythm change event rate was 4.1% (724/17 743) in the derivation cohort, and 4.0% (326/8061) in the validation cohorts. Age, sex, presence of a witness, initial rhythm, chest compression by a bystander, shock with an automated external defibrillator by a bystander, and cause of the cardiac arrest were all found to be independently associated with spontaneous rhythm change before hospital arrival. Based on this finding, we developed and validated the Rhythm Change Before Hospital Arrival for Nonshockable score. The Harrell’s concordance index values of the score were 0.71 and 0.67 in the internal and external validations, respectively. Conclusions Seven factors were identified as predictors of a spontaneous rhythm change from nonshockable to shockable before hospital arrival. We developed and validated a score to predict rhythm change before hospital arrival.
{"title":"Prediction of Prehospital Change of the Cardiac Rhythm From Nonshockable to Shockable in Out‐of‐Hospital Patients With Cardiac Arrest: A Post Hoc Analysis of a Nationwide, Multicenter, Prospective Registry","authors":"R. Emoto, M. Nishikimi, M. Shoaib, Kei Hayashida, Kazuki Nishida, K. Kikutani, S. Ohshimo, S. Matsui, N. Shime, T. Iwami","doi":"10.1161/JAHA.121.025048","DOIUrl":"https://doi.org/10.1161/JAHA.121.025048","url":null,"abstract":"Background Predicting a spontaneous rhythm change from nonshockable to shockable before hospital arrival in patients with out‐of‐hospital cardiac arrest can help emergency medical services develop better strategies for prehospital treatment. The aim of this study was to identify predictors of spontaneous rhythm change before hospital arrival in patients with out‐of‐hospital cardiac arrest and develop a predictive scoring system. Methods and Results We retrospectively reviewed data of eligible patients with out‐of‐hospital cardiac arrest with an initial nonshockable rhythm registered in a nationwide registry between June 2014 and December 2017. We performed a multivariable analysis using a Cox proportional hazards model to identify predictors of a spontaneous rhythm change, and a ridge regression model for predicting it. The data of 25 804 patients were analyzed (derivation cohort, n=17 743; validation cohort, n=8061). The rhythm change event rate was 4.1% (724/17 743) in the derivation cohort, and 4.0% (326/8061) in the validation cohorts. Age, sex, presence of a witness, initial rhythm, chest compression by a bystander, shock with an automated external defibrillator by a bystander, and cause of the cardiac arrest were all found to be independently associated with spontaneous rhythm change before hospital arrival. Based on this finding, we developed and validated the Rhythm Change Before Hospital Arrival for Nonshockable score. The Harrell’s concordance index values of the score were 0.71 and 0.67 in the internal and external validations, respectively. Conclusions Seven factors were identified as predictors of a spontaneous rhythm change from nonshockable to shockable before hospital arrival. We developed and validated a score to predict rhythm change before hospital arrival.","PeriodicalId":17189,"journal":{"name":"Journal of the American Heart Association: Cardiovascular and Cerebrovascular Disease","volume":"56 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2022-06-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"85332672","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Arielle M Schwartz, Esther Kim, Patrick T. Gleason, Xiaona Li, Y. Ko, Bryan J Wells
Background Fibromuscular dysplasia (FMD) is a disease of unknown etiology that causes stenosis, aneurysmal dilatation, and dissection of vascular beds. Known to affect medium‐sized arteries, FMD is not typically considered to affect the aorta. We tested the hypothesis that aortic size in FMD is abnormal compared with age‐ and sex‐matched controls. Methods and Results Medical records and computed tomography angiography images were reviewed in female patients with a diagnosis of FMD who were seen in the vascular medicine clinic at Emory Healthcare. Aortic dimensions were measured at 6 different landmarks. Using 2 sample t tests, the aortic measurements and height‐indexed measurements were compared with published normal values in healthy women of a similar age. A total of 94 female patients were included in the study. The median age was 57 (interquartile range, 50–65). FMD involvement was present most commonly in the extracranial carotid (77.7%) and renal (43.6%) arteries. All 6 aortic segments were found to be larger in both absolute measures and height‐indexed measures in the FMD population (P<0.001). The largest differences were observed within the absolute measures of the sinotubular junction with mean±SD (mm) (29.9±4.1) versus (27±2.5), ascending aorta (32.7±4.4) versus (30.0±3.5), and descending aorta (24.7±3.0) versus (22.0±2.0) (P<0.001). Conclusions Aortic diameters in female patients with FMD are larger when compared with published age‐ and sex‐matched normal values. These findings suggest that FMD may also affect the large‐sized arteries.
{"title":"Aortic Dimensions Are Larger in Patients With Fibromuscular Dysplasia","authors":"Arielle M Schwartz, Esther Kim, Patrick T. Gleason, Xiaona Li, Y. Ko, Bryan J Wells","doi":"10.1161/JAHA.121.023858","DOIUrl":"https://doi.org/10.1161/JAHA.121.023858","url":null,"abstract":"Background Fibromuscular dysplasia (FMD) is a disease of unknown etiology that causes stenosis, aneurysmal dilatation, and dissection of vascular beds. Known to affect medium‐sized arteries, FMD is not typically considered to affect the aorta. We tested the hypothesis that aortic size in FMD is abnormal compared with age‐ and sex‐matched controls. Methods and Results Medical records and computed tomography angiography images were reviewed in female patients with a diagnosis of FMD who were seen in the vascular medicine clinic at Emory Healthcare. Aortic dimensions were measured at 6 different landmarks. Using 2 sample t tests, the aortic measurements and height‐indexed measurements were compared with published normal values in healthy women of a similar age. A total of 94 female patients were included in the study. The median age was 57 (interquartile range, 50–65). FMD involvement was present most commonly in the extracranial carotid (77.7%) and renal (43.6%) arteries. All 6 aortic segments were found to be larger in both absolute measures and height‐indexed measures in the FMD population (P<0.001). The largest differences were observed within the absolute measures of the sinotubular junction with mean±SD (mm) (29.9±4.1) versus (27±2.5), ascending aorta (32.7±4.4) versus (30.0±3.5), and descending aorta (24.7±3.0) versus (22.0±2.0) (P<0.001). Conclusions Aortic diameters in female patients with FMD are larger when compared with published age‐ and sex‐matched normal values. These findings suggest that FMD may also affect the large‐sized arteries.","PeriodicalId":17189,"journal":{"name":"Journal of the American Heart Association: Cardiovascular and Cerebrovascular Disease","volume":"18 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2022-06-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"81830903","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
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