Pub Date : 2015-12-01DOI: 10.1016/j.ctrsc.2015.10.005
Uri Gabbay , Ben-Zion Bobrovsky , Issahar Ben-Dov , Ronen Durst , Itay E. Gabbay , Michael J. Segel
Background
Cardiovascular reserve index (CVRI) was previously proposed as an estimate of the assumed (momentary) cardiovascular reserve as a function of stroke volume (SV), systemic vascular resistance (SVR), respiratory rate (RR) and body surface area (BSA). Conversion through conventional hemodynamic equations reveals an equivalent, simpler, vital signs based function. We evaluated the association between CVRI and diverse conditions along the hemodynamic spectrum.
Methods
CVRI was retrospectively computed for each subject of 3 existing patient databases. 1) Acute severe hospital admissions [N = 333] classified by disease course to: “shock on arrival”, “developing shock” and “non-shock”. 2) Heart failure (HF) patients [N = 71] classified by HF severity to: mild, moderate and severe HF. 3) Cardio-pulmonary exercise testing (CPX) [n = 387] classified by exercise capacity (EC) to: normal, mildly decrease, moderately decrease and severely decreased EC. CVRI association with these hemodynamic conditions was evaluated through ANOVA.
Results
‘Normal EC’ has the highest CVRI of 0.97 (0.88, 1.06), and in decreasing CVRI order ‘mildly decrease EC’, ‘moderately decrease EC’, ‘mild HF’ which was similar to ‘severely decrease EC’, ‘moderate HF’ which was similar to acute severe admission of ‘non-shock’, ‘severe heart failure’ which was similar to ‘developing shock’ and the lowest CVRI was observed in ‘shock on arrival’ with mean CVRI of 0.20 (0.19, 0.22), ANOVA p < 0.001.
Conclusions
Mean CVRI exhibited consistent inverse association with the severity of the hemodynamic condition. However, CVRI clinical utility of an individual patient requires further studies.
{"title":"From a cardio-vascular reserve hypothesis to a proposed measurable index: A pilot empirical validation","authors":"Uri Gabbay , Ben-Zion Bobrovsky , Issahar Ben-Dov , Ronen Durst , Itay E. Gabbay , Michael J. Segel","doi":"10.1016/j.ctrsc.2015.10.005","DOIUrl":"10.1016/j.ctrsc.2015.10.005","url":null,"abstract":"<div><h3>Background</h3><p>Cardiovascular reserve index (CVRI) was previously proposed as an estimate of the assumed (momentary) cardiovascular reserve as a function of stroke volume (SV), systemic vascular resistance (SVR), respiratory rate (RR) and body surface area (BSA). Conversion through conventional hemodynamic equations reveals an equivalent, simpler, vital signs based function. We evaluated the association between CVRI and diverse conditions along the hemodynamic spectrum.</p></div><div><h3>Methods</h3><p>CVRI was retrospectively computed for each subject of 3 existing patient databases. 1) Acute severe hospital admissions [N<!--> <!-->=<!--> <!-->333] classified by disease course to: “shock on arrival”, “developing shock” and “non-shock”. 2) Heart failure (HF) patients [N<!--> <!-->=<!--> <!-->71] classified by HF severity to: mild, moderate and severe HF. 3) Cardio-pulmonary exercise testing (CPX) [n<!--> <!-->=<!--> <!-->387] classified by exercise capacity (EC) to: normal, mildly decrease, moderately decrease and severely decreased EC. CVRI association with these hemodynamic conditions was evaluated through ANOVA.</p></div><div><h3>Results</h3><p>‘Normal EC’ has the highest CVRI of 0.97 (0.88, 1.06), and in decreasing CVRI order ‘mildly decrease EC’, ‘moderately decrease EC’, ‘mild HF’ which was similar to ‘severely decrease EC’, ‘moderate HF’ which was similar to acute severe admission of ‘non-shock’, ‘severe heart failure’ which was similar to ‘developing shock’ and the lowest CVRI was observed in ‘shock on arrival’ with mean CVRI of 0.20 (0.19, 0.22), ANOVA p<!--> <!--><<!--> <!-->0.001.</p></div><div><h3>Conclusions</h3><p>Mean CVRI exhibited consistent inverse association with the severity of the hemodynamic condition. However, CVRI clinical utility of an individual patient requires further studies.</p></div>","PeriodicalId":91232,"journal":{"name":"Clinical trials and regulatory science in cardiology","volume":"12 ","pages":"Pages 1-5"},"PeriodicalIF":0.0,"publicationDate":"2015-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1016/j.ctrsc.2015.10.005","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"54051566","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2015-12-01DOI: 10.1016/j.ctrsc.2015.10.006
Lin Ho Wong , Peter Ting , David Kerins
Background
Normal blood pressure (BP) follows a circadian rhythm, with dipping of BP at night. However, knowledge is limited in how the nocturnal dipping in hypertensive patients changes with the seasons. The study aims to examine the pattern of seasonal changes of nocturnal dip in an Irish population and furthermore, to compare it to the pattern observed near the equator where such seasonal variations are minimal, by also studying a Singaporean population.
Methods
Ambulatory Blood Pressure Monitor recordings were obtained from 220 patients, half were from Mercy University Hospital, Cork, Ireland and half from the National Heart Centre, Singapore during the summer period from May to June and the winter period from October to December.
Results
Irish seasonal changes resulted in an increase in nocturnal dipping in the hypertensive patients, especially for diastolic pressure (95% CI, 0.72 to 6.03, 3.37mmHg; p<0.05) and a change in the duration of dipping at night (95% CI, 0.045 to 1.01, 0.53h; p < 0.05). In Singapore, slight differences in dipping in systolic pressure were apparent despite the presence of only minor alterations in temperature (95% CI, 0.38 to 4.83, 2.61mmHg; P<0.05) or duration of daylight.
Conclusion
Seasonal changes not only affected the daily blood pressure but also the night time dipping status in hypertensive patients by mean value of 1.99mmHg and 3.38mmHg for systolic and diastolic pressure dip respectively. This has implications on how hypertensive patients should be treated during different seasons and when they are traveling to countries of different climatic environment.
{"title":"Seasonal variations in nocturnal changes in blood pressure between Ireland and Singapore","authors":"Lin Ho Wong , Peter Ting , David Kerins","doi":"10.1016/j.ctrsc.2015.10.006","DOIUrl":"10.1016/j.ctrsc.2015.10.006","url":null,"abstract":"<div><h3>Background</h3><p>Normal blood pressure (BP) follows a circadian rhythm, with dipping of BP at night. However, knowledge is limited in how the nocturnal dipping in hypertensive patients changes with the seasons. The study aims to examine the pattern of seasonal changes of nocturnal dip in an Irish population and furthermore, to compare it to the pattern observed near the equator where such seasonal variations are minimal, by also studying a Singaporean population.</p></div><div><h3>Methods</h3><p>Ambulatory Blood Pressure Monitor recordings were obtained from 220 patients, half were from Mercy University Hospital, Cork, Ireland and half from the National Heart Centre, Singapore during the summer period from May to June and the winter period from October to December.</p></div><div><h3>Results</h3><p>Irish seasonal changes resulted in an increase in nocturnal dipping in the hypertensive patients, especially for diastolic pressure (95% CI, 0.72 to 6.03, 3.37mmHg; p<0.05) and a change in the duration of dipping at night (95% CI, 0.045 to 1.01, 0.53h; p<!--> <!--><<!--> <!-->0.05). In Singapore, slight differences in dipping in systolic pressure were apparent despite the presence of only minor alterations in temperature (95% CI, 0.38 to 4.83, 2.61mmHg; P<0.05) or duration of daylight.</p></div><div><h3>Conclusion</h3><p>Seasonal changes not only affected the daily blood pressure but also the night time dipping status in hypertensive patients by mean value of 1.99mmHg and 3.38mmHg for systolic and diastolic pressure dip respectively. This has implications on how hypertensive patients should be treated during different seasons and when they are traveling to countries of different climatic environment.</p></div>","PeriodicalId":91232,"journal":{"name":"Clinical trials and regulatory science in cardiology","volume":"12 ","pages":"Pages 12-17"},"PeriodicalIF":0.0,"publicationDate":"2015-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1016/j.ctrsc.2015.10.006","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"54051651","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2015-12-01DOI: 10.1016/j.ctrsc.2015.10.004
Steven Niederer , Cameron Walker , Andrew Crozier , Eoin R. Hyde , Bojan Blazevic , Jonathan M. Behar , Simon Claridge , Manav Sohal , Anoop Shetty , Tom Jackson , Christopher Rinaldi
Background
Acute indicators of response to cardiac resynchronisation therapy (CRT) are critical for developing lead optimisation algorithms and evaluating novel multi-polar, multi-lead and endocardial pacing protocols. Accounting for beat-to-beat variability in measures of acute haemodynamic response (AHR) may help clinicians understand the link between acute measurements of cardiac function and long term clinical outcome.
Methods and results
A retrospective study of invasive pressure tracings from 38 patients receiving an acute pacing and electrophysiological study was performed. 602 pacing protocols for left ventricle (LV) (n = 38), atria–ventricle (AV) (n = 9), ventricle–ventricle (VV) (n = 12) and endocardial (ENDO) (n = 8) optimisation were performed. AHR was measured as the maximal rate of LV pressure development (dP/dtMx) for each beat. The range of the 95% confidence interval (CI) of mean AHR was ~ 7% across all optimisation protocols compared with the reported CRT response cut off value of 10%. A single clear optimal protocol was identifiable in 61%, 22%, 25% and 50% for LV, AV, VV and ENDO optimisation cases, respectively. A level of service (LOS) optimisation that aimed to maximise the expected AHR 5th percentile, minimising variability and maximising AHR, led to distinct optimal protocols from conventional mean AHR optimisation in 34%, 78%, 67% and 12.5% of LV, AV, VV and ENDO optimisation cases, respectively.
Conclusion
The beat-to-beat variation in AHR is significant in the context of CRT cut off values. A LOS optimisation offers a novel index to identify the optimal pacing site that accounts for both the mean and variation of the baseline measurement and pacing protocol.
{"title":"The impact of beat-to-beat variability in optimising the acute hemodynamic response in cardiac resynchronisation therapy","authors":"Steven Niederer , Cameron Walker , Andrew Crozier , Eoin R. Hyde , Bojan Blazevic , Jonathan M. Behar , Simon Claridge , Manav Sohal , Anoop Shetty , Tom Jackson , Christopher Rinaldi","doi":"10.1016/j.ctrsc.2015.10.004","DOIUrl":"10.1016/j.ctrsc.2015.10.004","url":null,"abstract":"<div><h3>Background</h3><p>Acute indicators of response to cardiac resynchronisation therapy (CRT) are critical for developing lead optimisation algorithms and evaluating novel multi-polar, multi-lead and endocardial pacing protocols. Accounting for beat-to-beat variability in measures of acute haemodynamic response (AHR) may help clinicians understand the link between acute measurements of cardiac function and long term clinical outcome.</p></div><div><h3>Methods and results</h3><p>A retrospective study of invasive pressure tracings from 38 patients receiving an acute pacing and electrophysiological study was performed. 602 pacing protocols for left ventricle (LV) (n<!--> <!-->=<!--> <!-->38), atria–ventricle (AV) (n<!--> <!-->=<!--> <!-->9), ventricle–ventricle (VV) (n<!--> <!-->=<!--> <!-->12) and endocardial (ENDO) (n<!--> <!-->=<!--> <!-->8) optimisation were performed. AHR was measured as the maximal rate of LV pressure development (dP/dt<sub>Mx</sub>) for each beat. The range of the 95% confidence interval (CI) of mean AHR was ~<!--> <!-->7% across all optimisation protocols compared with the reported CRT response cut off value of 10%. A single clear optimal protocol was identifiable in 61%, 22%, 25% and 50% for LV, AV, VV and ENDO optimisation cases, respectively. A level of service (LOS) optimisation that aimed to maximise the expected AHR 5th percentile, minimising variability and maximising AHR, led to distinct optimal protocols from conventional mean AHR optimisation in 34%, 78%, 67% and 12.5% of LV, AV, VV and ENDO optimisation cases, respectively.</p></div><div><h3>Conclusion</h3><p>The beat-to-beat variation in AHR is significant in the context of CRT cut off values. A LOS optimisation offers a novel index to identify the optimal pacing site that accounts for both the mean and variation of the baseline measurement and pacing protocol.</p></div>","PeriodicalId":91232,"journal":{"name":"Clinical trials and regulatory science in cardiology","volume":"12 ","pages":"Pages 18-22"},"PeriodicalIF":0.0,"publicationDate":"2015-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1016/j.ctrsc.2015.10.004","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"54051545","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2015-11-01DOI: 10.1016/j.ctrsc.2015.09.003
Reinaldo B. Bestetti , Augusto Cardinalli-Neto , Ana Paula Otaviano , Marcelo A. Nakazone , Natália D. Bertolino , Paulo R. Nogueira
Background
The prevalence, the clinical characteristics and the impact of hyponatremia on the prognosis of patients with chronic heart failure secondary to Chagas cardiomyopathy is unknown.
Methods
All patients with positive serology for Chagas disease and a left ventricular ejection fraction < 55% on echocardiography routinely followed at the cardiomyopathy service of the university hospital from January, 2000 to December, 2008 were screened. The work-up consisted of anamnesis, physical examination, standard laboratory tests, 12-lead resting ECG, and 2-D echocardiography. Hyponatremia was defined as serum sodium levels < 135 mEq/L.
Results
246 patients were entered in the study; 30 (12%) patients were found to have hyponatremia. A multivariate stepwise logistic regression analysis revealed that the need of inotropic support [hazard ratio (HR) = 2.97; 95% Confidence Interval (CI) 1.24 to 7,18; p = 0.01], left ventricular systolic diameter (HR = 1.05; 95% CI 1.0 to 1.1, p = 0.03), and diastolic blood pressure (HR: 0,96; 95% CI 0,92 to 0,99; p = 0.04) were independent predictors of hyponatremia. A Cox regression analysis showed that the need of inotropic support (HR = 1,84; 95% CI 1,24 to 2,72; p = 0,0002), hyponatremia (HR = 2,05; 95% CI 1,25 to 3,38; p = 0.005), Betablocker therapy (hazard ratio = 0,33; 95% Confidence Interval 0,22 to 0,50; p < 0,0005), and digoxin use (HR = 2,79; 95% CI 1,42 to 5,46; p = 0003) were independent predictors of all-cause mortality.
Conclusion
Hyponatremia is an independent predictor of all-cause mortality of patients with chronic heart failure secondary to Chagas cardiomyopathy in the contemporary era of syndrome management. Hyponatremia can be predicted by variables consistent with syndrome severity.
{"title":"Hyponatremia in Chagas disease heart failure: Prevalence, clinical characteristics, and prognostic importance","authors":"Reinaldo B. Bestetti , Augusto Cardinalli-Neto , Ana Paula Otaviano , Marcelo A. Nakazone , Natália D. Bertolino , Paulo R. Nogueira","doi":"10.1016/j.ctrsc.2015.09.003","DOIUrl":"10.1016/j.ctrsc.2015.09.003","url":null,"abstract":"<div><h3>Background</h3><p>The prevalence, the clinical characteristics and the impact of hyponatremia on the prognosis of patients with chronic heart failure secondary to Chagas cardiomyopathy is unknown.</p></div><div><h3>Methods</h3><p>All patients with positive serology for Chagas disease and a left ventricular ejection fraction <<!--> <!-->55% on echocardiography routinely followed at the cardiomyopathy service of the university hospital from January, 2000 to December, 2008 were screened. The work-up consisted of anamnesis, physical examination, standard laboratory tests, 12-lead resting ECG, and 2-D echocardiography. Hyponatremia was defined as serum sodium levels <<!--> <!-->135<!--> <!-->mEq/L.</p></div><div><h3>Results</h3><p>246 patients were entered in the study; 30 (12%) patients were found to have hyponatremia. A multivariate stepwise logistic regression analysis revealed that the need of inotropic support [hazard ratio (HR)<!--> <!-->=<!--> <!-->2.97; 95% Confidence Interval (CI) 1.24 to 7,18; p<!--> <!-->=<!--> <!-->0.01], left ventricular systolic diameter (HR<!--> <!-->=<!--> <!-->1.05; 95% CI 1.0 to 1.1, p<!--> <!-->=<!--> <!-->0.03), and diastolic blood pressure (HR: 0,96; 95% CI 0,92 to 0,99; p<!--> <!-->=<!--> <!-->0.04) were independent predictors of hyponatremia. A Cox regression analysis showed that the need of inotropic support (HR<!--> <!-->=<!--> <!-->1,84; 95% CI 1,24 to 2,72; p<!--> <!-->=<!--> <!-->0,0002), hyponatremia (HR<!--> <!-->=<!--> <!-->2,05; 95% CI 1,25 to 3,38; p<!--> <!-->=<!--> <!-->0.005), Betablocker therapy (hazard ratio<!--> <!-->=<!--> <!-->0,33; 95% Confidence Interval 0,22 to 0,50; p<!--> <!--><<!--> <!-->0,0005), and digoxin use (HR<!--> <!-->=<!--> <!-->2,79; 95% CI 1,42 to 5,46; p<!--> <!-->=<!--> <!-->0003) were independent predictors of all-cause mortality.</p></div><div><h3>Conclusion</h3><p>Hyponatremia is an independent predictor of all-cause mortality of patients with chronic heart failure secondary to Chagas cardiomyopathy in the contemporary era of syndrome management. Hyponatremia can be predicted by variables consistent with syndrome severity.</p></div>","PeriodicalId":91232,"journal":{"name":"Clinical trials and regulatory science in cardiology","volume":"11 ","pages":"Pages 6-9"},"PeriodicalIF":0.0,"publicationDate":"2015-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1016/j.ctrsc.2015.09.003","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"54051849","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2015-11-01DOI: 10.1016/j.ctrsc.2015.10.002
Wei-Chieh Lee , Chih-Yuan Fang , Chien-Fu Huang , Ying-Jui Lin , Chiung-Jen Wu , Hsiu-Yu Fang
Objective
Technical difficulties still exist for the catheter closure of atrial septal defects (ASD) in some of the morphological features of defects, or hemodynamic features in the population. The morphological or hemodynamic features are (1) large ASD, (2) wide rim deficiency, (3) multiple defects, (4) severe pulmonary hypertension, (5) ventricular dysfunction, and (6) restrictive left ventricular compliance. Our study aimed to assess the efficacy of transcatheter closure of complex ASDs under transesophageal echocardiography (TEE) guidance in adolescents and adults, and figured out the predictors of atrial septum occluder (ASO) dislodgement.
Methods
From June 2003 to June 2014, 125 adults and 12 adolescents were diagnosed with secundum ASD and underwent a transcatheter closure of defects using an ASO. Among the above patients, 63 patients had morphological or hemodynamic features that made ASD closure difficult.
Results
No ASO dislodgement occurred in the non-complex ASD closure group, and an 88.9% success rate was observed in the complex ASD closure group. Higher Qp/Qs ratio, higher incidence of multiple ASDs, and larger ASD size in the complex ASD closure group were noted. 50.8% patients in complex ASD closure group had ASD ≧ 30 mm. Multivariate analysis demonstrated that an occurrence of eroded and IAS or aneurysm formation and arrhythmia during implantation were independent predictors for ASO dislodgement in complex ASD closure (p = 0.005; p = 0.037).
Conclusion
Eroded and floppy IAS or aneurysm formation post ASO implantation and peri-procedure arrhythmia could predict ASO dislodgement in complex ASD closure. Transcatheter closure of ASDs under TEE guidance is feasible in complex cases.
{"title":"The predictors of dislodgement and outcomes of transcatheter closure of complex atrial septal defects in adolescents and adults","authors":"Wei-Chieh Lee , Chih-Yuan Fang , Chien-Fu Huang , Ying-Jui Lin , Chiung-Jen Wu , Hsiu-Yu Fang","doi":"10.1016/j.ctrsc.2015.10.002","DOIUrl":"10.1016/j.ctrsc.2015.10.002","url":null,"abstract":"<div><h3>Objective</h3><p>Technical difficulties still exist for the catheter closure of atrial septal defects (ASD) in some of the morphological features of defects, or hemodynamic features in the population. The morphological or hemodynamic features are (1) large ASD, (2) wide rim deficiency, (3) multiple defects, (4) severe pulmonary hypertension, (5) ventricular dysfunction, and (6) restrictive left ventricular compliance. Our study aimed to assess the efficacy of transcatheter closure of complex ASDs under transesophageal echocardiography (TEE) guidance in adolescents and adults, and figured out the predictors of atrial septum occluder (ASO) dislodgement.</p></div><div><h3>Methods</h3><p>From June 2003 to June 2014, 125 adults and 12 adolescents were diagnosed with secundum ASD and underwent a transcatheter closure of defects using an ASO. Among the above patients, 63 patients had morphological or hemodynamic features that made ASD closure difficult.</p></div><div><h3>Results</h3><p>No ASO dislodgement occurred in the non-complex ASD closure group, and an 88.9% success rate was observed in the complex ASD closure group. Higher Qp/Qs ratio, higher incidence of multiple ASDs, and larger ASD size in the complex ASD closure group were noted. 50.8% patients in complex ASD closure group had ASD<!--> <!-->≧<!--> <!-->30<!--> <!-->mm. Multivariate analysis demonstrated that an occurrence of eroded and IAS or aneurysm formation and arrhythmia during implantation were independent predictors for ASO dislodgement in complex ASD closure (p<!--> <!-->=<!--> <!-->0.005; p<!--> <!-->=<!--> <!-->0.037).</p></div><div><h3>Conclusion</h3><p>Eroded and floppy IAS or aneurysm formation post ASO implantation and peri-procedure arrhythmia could predict ASO dislodgement in complex ASD closure. Transcatheter closure of ASDs under TEE guidance is feasible in complex cases.</p></div>","PeriodicalId":91232,"journal":{"name":"Clinical trials and regulatory science in cardiology","volume":"11 ","pages":"Pages 1-5"},"PeriodicalIF":0.0,"publicationDate":"2015-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1016/j.ctrsc.2015.10.002","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"54051474","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2015-10-20DOI: 10.1016/J.CTRSC.2015.10.003
G. Guimãraes, M. M. Fernandes-Silva, E. Ciolac, L. G. D. B. Cruz, A. C. Tavares, R. E. Castro, E. Bocchi
{"title":"WITHDRAWN: Sustained effects of heated water-based exercise on blood pressure in resistant hypertension: 3-month follow-up from the HEx trial","authors":"G. Guimãraes, M. M. Fernandes-Silva, E. Ciolac, L. G. D. B. Cruz, A. C. Tavares, R. E. Castro, E. Bocchi","doi":"10.1016/J.CTRSC.2015.10.003","DOIUrl":"https://doi.org/10.1016/J.CTRSC.2015.10.003","url":null,"abstract":"","PeriodicalId":91232,"journal":{"name":"Clinical trials and regulatory science in cardiology","volume":"1 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2015-10-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1016/J.CTRSC.2015.10.003","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"54051529","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}
Pub Date : 2015-10-01DOI: 10.1016/j.ctrsc.2015.09.004
K. Teeuwen , S. Hubbers , Jan G.P. Tijssen , J.A.S. Van Der Heyden , B.J.W.M. Rensing , M.J. Suttorp
Background
Data on procedural and clinical outcomes of the everolimus-eluting bioresorbable vascular scaffold (BVS, Abbott) in percutaneous coronary intervention in a real-world setting is limited. Early and mid-term clinical outcomes of the BVS in a real-world population were investigated in this single centre study.
Methods
Patients treated with the BVS in the St. Antonius Hospital from April 2012 to February 2015 were included in a prospective single centre registry. Procedural success defined as < 20% residual restenosis and 30-day and 6-month clinical outcome were investigated. Cumulative event rates were expressed using Kaplan − Meier method.
Results
A total of 108 patients were included in the study, including patients with ST-segment elevation myocardial infarction (STEMI) 18.5%, non-STEMI 22.2% and unstable angina 9.3%. In total 125 lesions were treated with the BVS, of which 48.8% B2/C type lesions including 19.2% bare metal or drugs-eluting in-stent restenosis. Procedural angiographic success was achieved in 99.2% of all patients. Clinical follow-up rate was 100% at 30-day and 87% at 6-month. The rate of cardiac death, target vessel revascularization and definite stent thrombosis was 0%, 0.9% and 0.9% at 30-day and 0.9%, 5.6% and 1.9% at 6-month. The composite end point of target lesion failure (Cardiac death, target lesion myocardial infarction MI and target lesion revascularization) was 1.9% at 30-day and 5.6% at 6-month, respectively.
Conclusions
The use of the BVS in a real-world setting demonstrated excellent procedural success and acceptable mid-term clinical outcomes. The rate of definite scaffold thrombosis was not dissimilar to other BVS registries.
{"title":"Experiences with the Absorb everolimus-eluting bioresorbable vascular scaffold in all comers: The St. Antonius hospital single centre registry","authors":"K. Teeuwen , S. Hubbers , Jan G.P. Tijssen , J.A.S. Van Der Heyden , B.J.W.M. Rensing , M.J. Suttorp","doi":"10.1016/j.ctrsc.2015.09.004","DOIUrl":"10.1016/j.ctrsc.2015.09.004","url":null,"abstract":"<div><h3>Background</h3><p>Data on procedural and clinical outcomes of the everolimus-eluting bioresorbable vascular scaffold (BVS, Abbott) in percutaneous coronary intervention in a real-world setting is limited. Early and mid-term clinical outcomes of the BVS in a real-world population were investigated in this single centre study.</p></div><div><h3>Methods</h3><p>Patients treated with the BVS in the St. Antonius Hospital from April 2012 to February 2015 were included in a prospective single centre registry. Procedural success defined as <<!--> <!-->20% residual restenosis and 30-day and 6-month clinical outcome were investigated. Cumulative event rates were expressed using Kaplan<!--> <!-->−<!--> <!-->Meier method.</p></div><div><h3>Results</h3><p>A total of 108 patients were included in the study, including patients with ST-segment elevation myocardial infarction (STEMI) 18.5%, non-STEMI 22.2% and unstable angina 9.3%. In total 125 lesions were treated with the BVS, of which 48.8% B2/C type lesions including 19.2% bare metal or drugs-eluting in-stent restenosis. Procedural angiographic success was achieved in 99.2% of all patients. Clinical follow-up rate was 100% at 30-day and 87% at 6-month. The rate of cardiac death, target vessel revascularization and definite stent thrombosis was 0%, 0.9% and 0.9% at 30-day and 0.9%, 5.6% and 1.9% at 6-month. The composite end point of target lesion failure (Cardiac death, target lesion myocardial infarction MI and target lesion revascularization) was 1.9% at 30-day and 5.6% at 6-month, respectively.</p></div><div><h3>Conclusions</h3><p>The use of the BVS in a real-world setting demonstrated excellent procedural success and acceptable mid-term clinical outcomes. The rate of definite scaffold thrombosis was not dissimilar to other BVS registries.</p></div>","PeriodicalId":91232,"journal":{"name":"Clinical trials and regulatory science in cardiology","volume":"10 ","pages":"Pages 1-6"},"PeriodicalIF":0.0,"publicationDate":"2015-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1016/j.ctrsc.2015.09.004","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"54051862","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2015-10-01DOI: 10.1016/j.ctrsc.2015.09.006
Kuljit Singh, George A. Wells, Derek Y. So, Christopher A. Glover, Michael Froeschl, Jean-François Marquis, Edward R. O'Brien, Benjamin Hibbert, Aun Yeong Chong, Alexander Dick, James Weaver, Marino Labinaz, Michel R. Le May
Background
Rapid inhibition of platelet function is critical in patients referred for primary percutaneous coronary intervention (PCI) to prevent stent thrombosis. We sought to determine the antiplatelet effects of two clopidogrel high loading dose (LD) strategies on platelet reactivity in patients presenting with ST-elevation myocardial infarction (STEMI).
Methods
Patients referred for primary PCI were randomly assigned to one of two clopidogrel LDs initiated before catheterization: 600 mg vs. 600/600 mg (second dose 3 h after first LD). Platelet function testing was performed at baseline, and at 1, 2, 4, 6, 24, and 48 h after the initial LD using the VerifyNow device. The primary endpoint was the proportion of patients with high platelet reactivity (HPR) at 24 h defined as a P2Y12 reaction unit (PRU) measurement > 208.
Results
Fifty-four patients were assigned to clopidogrel as a single 600 mg LD (n = 27) or as a 600/600 mg double LD (n = 27). The proportion of patients with HPR at 24 h was recorded in 44.0% assigned to the 600 mg LD and 24.0% of patients assigned to 600/600 mg LD, p = 0.23. The mean PRU at 24 h was 191 ± 102 in the 600 mg group and 152 ± 94 in the 600/600 mg group, p = 0.16. There was no difference at all time points in HPR, and in mean PRUs between the LD regimens.
Conclusions
High platelet reactivity persisted at 24 h in a significant proportion of patients referred for primary PCI regardless of two clopidogrel high LD strategies. These results may have implications regarding the risk of early stent thrombosis in STEMI patients treated with clopidogrel.
{"title":"Platelet reactivity following high loading doses of clopidogrel in patients undergoing primary percutaneous coronary angioplasty: A pilot study","authors":"Kuljit Singh, George A. Wells, Derek Y. So, Christopher A. Glover, Michael Froeschl, Jean-François Marquis, Edward R. O'Brien, Benjamin Hibbert, Aun Yeong Chong, Alexander Dick, James Weaver, Marino Labinaz, Michel R. Le May","doi":"10.1016/j.ctrsc.2015.09.006","DOIUrl":"10.1016/j.ctrsc.2015.09.006","url":null,"abstract":"<div><h3>Background</h3><p>Rapid inhibition of platelet function is critical in patients referred for primary percutaneous coronary intervention (PCI) to prevent stent thrombosis. We sought to determine the antiplatelet effects of two clopidogrel high loading dose (LD) strategies on platelet reactivity in patients presenting with ST-elevation myocardial infarction (STEMI).</p></div><div><h3>Methods</h3><p>Patients referred for primary PCI were randomly assigned to one of two clopidogrel LDs initiated before catheterization: 600<!--> <!-->mg vs. 600/600<!--> <!-->mg (second dose 3<!--> <!-->h after first LD). Platelet function testing was performed at baseline, and at 1, 2, 4, 6, 24, and 48<!--> <!-->h after the initial LD using the VerifyNow device. The primary endpoint was the proportion of patients with high platelet reactivity (HPR) at 24<!--> <!-->h defined as a P2Y12 reaction unit (PRU) measurement ><!--> <!-->208.</p></div><div><h3>Results</h3><p>Fifty-four patients were assigned to clopidogrel as a single 600<!--> <!-->mg LD (n<!--> <!-->=<!--> <!-->27) or as a 600/600<!--> <!-->mg double LD (n<!--> <!-->=<!--> <!-->27). The proportion of patients with HPR at 24<!--> <!-->h was recorded in 44.0% assigned to the 600<!--> <!-->mg LD and 24.0% of patients assigned to 600/600<!--> <!-->mg LD, p<!--> <!-->=<!--> <!-->0.23. The mean PRU at 24<!--> <!-->h was 191<!--> <!-->±<!--> <!-->102 in the 600<!--> <!-->mg group and 152<!--> <!-->±<!--> <!-->94 in the 600/600<!--> <!-->mg group, p<!--> <!-->=<!--> <!-->0.16. There was no difference at all time points in HPR, and in mean PRUs between the LD regimens.</p></div><div><h3>Conclusions</h3><p>High platelet reactivity persisted at 24<!--> <!-->h in a significant proportion of patients referred for primary PCI regardless of two clopidogrel high LD strategies. These results may have implications regarding the risk of early stent thrombosis in STEMI patients treated with clopidogrel.</p></div>","PeriodicalId":91232,"journal":{"name":"Clinical trials and regulatory science in cardiology","volume":"10 ","pages":"Pages 7-12"},"PeriodicalIF":0.0,"publicationDate":"2015-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1016/j.ctrsc.2015.09.006","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"54051440","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"A case of spontaneous and simultaneous dissections of both common iliac arteries in a young patient","authors":"Daisuke Sueta , Seiji Hokimoto , Ryo Hirayama , Ryusuke Suzuki , Hisao Ogawa","doi":"10.1016/j.ctrsc.2015.09.002","DOIUrl":"10.1016/j.ctrsc.2015.09.002","url":null,"abstract":"","PeriodicalId":91232,"journal":{"name":"Clinical trials and regulatory science in cardiology","volume":"9 ","pages":"Pages 4-5"},"PeriodicalIF":0.0,"publicationDate":"2015-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1016/j.ctrsc.2015.09.002","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"54051837","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
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