bluuebunny/crossref_metadata_2025_split huggingface dataset:
P966Clinical impact of target vessel on long term cardiac survival in patients with chronic total occlusion treated by percutaneous coronary intervention
Authors: Bernardini A , Berteotti M , De Gregorio M G , Migliorini A , Carrabba N , Vergara R , Pennesi M , Valenti R 
Published: October 2019

Abstract

Background
Chronic total occlusions (CTOs) occur in 15–35% of patients with significant coronary artery disease who undergo coronary angiography. The rationale of percutaneous CTO revascularization is the improvement in survival and in quality of life, mainly reducing angina symptoms and increasing LVEF. The clinical impact of target vessel has been investigated in previous studies, with controversial results.

Purpose
The aim of this study, based on a large scale single-center registry, is to determine the impact of different target vessel successful CTO percutaneous coronary intervention (PCI) on long-term survival in a “real world” population.

Methods
All consecutive patients who attempted a CTO-PCI from 2004 to 2015 in our Hospital department were included in a CTO-PCI Registry. CTO was defined as a coronary obstruction with TIMI flow grade 0 with an estimated duration of >3 months. Patients with multiple CTO were excluded. Long-term mortality was assessed by Kaplan-Meier and Cox multivariable analysis.

Results
A total of 1235 patients attempted PCI for CTO; patients were stratified into two main groups according to the CTO carrying vessel: LAD-CTO (n=360) and not-LAD CTO (n=875). Cardiac survival rate at 5 years was lower in LAD-CTO patients compared with not-LAD CTO patients (85±3% vs. 90±2%; p=0.001), but when a successful CTO-PCI was achieved, there was no statistical difference between the two groups (89±3% vs. 93±1%; p=0.095). On the other side, a failure of the CTO PCI in LAD vessel was associated with a worse outcome (67±8% vs. 85±4%; p=0.001). Completeness of revascularization carried a significant survival benefit independently from the target vessel CTO (LAD CTO group 94±2% vs. not-LAD CTO group 95±1%; p=0.256), but an incomplete revascularization was associated with a worse outcome in LAD-CTO patients (67±6% vs. 81±4%; p<0.001). By multivariable Cox analysis, age >75 years, diabetes, left ventricular ejection fraction <40%, complete revascularization and LAD-CTO were independently related to death.

Conclusions
In a “real world” population, LAD-CTOs were associated with a lower cardiac survival rate when compared to other vessel CTOs; however, this survival gap was no longer significant when a successful CTO PCI was performed. The survival benefit was even greater when a complete coronary revascularization was achieved.
P1019Validation of a risk score to predict the need for pacemaker implantation after transcatheter aortic valve replacement
Authors: Kiani S , Kamioka N , Caughron H , Dong A , Patel H , Lisko J , Gleason P , Stewart J , Grubb K , Greenbaum A , Devireddy C , Guyton R , Leshnower B , Babaliaros V , Hoskins M 
Published: October 2019

Abstract

Background
New conduction abnormalities necessitating pacemaker implantation (PMI) is a common occurrence after TAVR. There is an increased rate of PMI in the those receiving the most contemporary implanted valve, the Edwards Sapien-3 (S3), compared to prior generation balloon expandable valves. We previously described predictors of PMI in a large cohort. Herein we sought to validate these predictors of PMI in a subsequent validation cohort.

Methods
We evaluated all patients undergoing first time elective TAVR with S3 at our institution (n=326). We developed a risk score based on a predictive model we have previously described. Patients received one point for each of the following: history of syncope, oversizing of the valve >16%, baseline right bundle branch block morphology, and two points for a QRS duration >115 ms. We performed regression analysis of the risk score and need for PMI. We also evaluated the performance of the risk score using ROC analysis.

Results
Thirty patients (8%) of the total cohort had need for PMI after S3 implantation. Those with PMI had a higher rate of pre-existing infra-nodal conduction system disease – including QRS duration >115ms (57% vs. 20%, p<0.001) and right bundle branch block (RBBB) morphology (47% vs. 10%, p<0.001) - as well as more frequent valve oversizing >15.7% (47% vs. 23%, p<0.01). There was no significant difference in a history of syncope (10% vs. 8%, p=0.72) between groups. The PMI risk score had an area under the curve of 0.753 on ROC analysis. The PMI risk score was significantly associated with PMI (OR 2.37; 95% CI [1.64–3.34], p<0.001).
Rate of PMI Stratified by Risk Score

Conclusions
The PMI risk score was strongly predictive of the need for PMI after implantation of the S3 valve in a large validation cohort. The PMI risk score performed well in sensitivity analysis. This PMI risk score represents a simple tool to help further risk stratify patients being considered for TAVR.
P1020Feasibility of pediatric probes in transesophageal echocardiography guiding of left atrial appendage closure in adults
Authors: Maarse M , Klaver M N , Swaans M J , Boersma L V A 
Published: October 2019

Abstract

Introduction
Transesophageal echocardiography (TEE) is essential in the guidance of left atrial appendage closure (LAAC). Current practice often requires general anesthetics (GA) to endure a standard size probe during LAAC procedures. Smaller probes for pediatric purposes have been developed and might be useful for the guidance of LAAC in adults, eliminating the need for general anesthetics (GA) and reducing procedure times.

Methods
In this prospective observational registry study patients were analyzed retrospectively to determine feasibility of pediatric TEE probes in adults for LAAC guidance. A standard set of LAA measurements, device compression and peri-device leakage was evaluated during procedure and by a second observer. Follow-up imaging, performed between 1–6 months after LAAC, was viewed by two independent reviewers for device positioning, peri-device leakage and thrombus formation.

Results
A total of 85 patients (56 male, mean age 72±7 years) were included. All patients underwent LAAC (76 Watchman, 9 Amplatzer Amulet), in 28 patients (33%) LAAC was combined with pulmonary vein isolation (PVI). The S8–3t micro-probe was used in 41 patients (48%) and the S7–3t mini-probe was used in 44 (52%). In 76 (38 mini-TEE, 38 micro-TEE) LAAC was successful, 7 of 9 failed procedures were due to unsuitable anatomy. Complete closure was achieved in 61/76 (80%, 29 mini-TEE, 32 micro-TEE), minimal residual flow was seen in 15/76 (20%, 8 mini-TEE, 7 micro-TEE). Device compression was comparable for mini- and micro-TEE and in accordance with recommendations. No GA was needed in 93% of the patients, none of these procedures were prematurely terminated because of discomfort. No serious probe related complications were seen. Follow-up imaging was performed 80±24 days after LAAC. Most patients (95%) underwent TOE with a standard probe for follow-up imaging, 5% of the patients underwent cardiac CT. Follow-up imaging showed similar proportions of patients with complete LAA closure (74%) or minimal residual flow (23%), while 2 patients had significant peri-device flow: 1 due to significant change in device position and 1 due to increase of peri-device leakage present during implant. In 1 patient device-related thrombus was seen and in 1 patient device embolization to the abdominal aorta occurred.

Conclusions
The use of pediatric probes in the guidance for LAAC in adults is a safe, effective, and attractive alternative avoiding the need for general anesthesia.
1171Myocardial perfusion mapping in cardiac amyloidosis - exploring the spectrum from infiltration to ischaemia
Authors: Chacko L , Kotecha T , Martinez-Naharro A , Brown J , Knight D , Steriotis A , Little C , Moon J , Gilmore J , Hawkins P , Rakhit R , Patel N , Xue H , Kellman P , Fontana M 
Published: October 2019

Abstract

Background
Cardiac involvement is the main driver of outcome in systemic amyloidosis, but the relationship between amyloid deposits and outcomes is not well understood. The simple explanation of physical, mechanical replacement of the interstitium by amyloid seems insufficient. Preliminary studies support the hypothesis that myocardial ischaemia could contribute to cell damage.

Purpose
(1) To assess myocardial ischaemia in cardiac amyloidosis. (2) To compare patients with cardiac amyloidosis to patients assessed on invasive coronary angiography (ICA) to have normal coronary physiology (NCP), microvascular dysfunction (MVD) and triple vessel coronary disease (3VD). (3) To assess correlation of perfusion mapping to markers of disease severity and prognosis.

Methods
86 patients and 20 healthy volunteers (HV) underwent CMR at 1.5T (Siemens) with standard cine, PSIR-LGE, T1, T2, Extracellular Volume (ECV) mapping and adenosine stress with myocardial blood flow (MBF) mapping. Thirty-eight patients also underwent ICA with 3 vessel assessment of Index of Microcirculatory Resistance and Fractional Flow Reserve: 7 had cardiac amyloidosis, 8 had NCP, 15 had MVD and 8 had 3VD.

Results
Cardiac amyloidosis patients had severe reduction in stress MBF and myocardial perfusion reserve (MPR) (1.22ml/g/min±0.70 and 1.62±0.63) compared to HV (3.21ml/g/min±0.64, p<0.001 and 4.17±0.78, p<0.001), NCP (2.66±0.56, p<0.001 and 2.51±0.43, p=0.036) and MVD (2.10±0.31, p<0.001 and 2.29±0.87, p=0.014) with the degree of reduction being similar only to patients with 3VD (1.44±0.54, p=1.000 and 1.64±0.68, p=1.000) (Figure 1). Rest MBF was also lower in amyloidosis than HV. Cardiac amyloidosis stress MBF and MPR inversely correlated with amyloid burden (ECV, r=−0.715, p<0.001, transmurality of LGE, p<0.01), systolic dysfunction (EF, r=0.405, p<0.01), and blood biomarkers (NT-proBNP (r=−0.678, p<0.001) and Troponin T (r=−0.628, p<0.001)). There was a correlation between stress MBF and native T1 (r=−0.588, p<0.001) but not T2 (p=0.591). Stress MBF and MPR were early disease markers, being elevated in patients with early cardiac amyloid infiltration (raised ECV, no LGE, P<0.01 vs HV).

Conclusion
Myocardial ischaemia is common in cardiac amyloidosis – with stress MBF and MPR similar to that of patients with 3VD. The reduction correlates with the degree of amyloid infiltration and markers of adverse prognosis, highlighting the potential role of myocardial ischaemia as a key mechanism in the pathophysiology of cardiac amyloidosis.
1384MitraClip treatment of functional mitral regurgitation - A meta-analysis
Authors: Noutsias M , Matiakis M , Ali M , Abate E , Ahmadzada B , Novruzlu R , Bigalke B , Rigopoulos A 
Published: October 2019

Abstract

Moderate-to-severe or severe functional mitral regurgitation (FMR) is associated with higher rates of hospitalizations and with increased mortality in heart failure with reduced left ventricular ejection fraction (HFrEF). Transcatheter mitral valve repair by MitraClip® implantation (TMVrMC) may effectively reduce severe MR, and is associated with symptomatic improvement. However, the long-term clinical effects of this procedure are not well defined.

Aims
We analyzed outcomes for rehospitalization and survival in heart failure patients with moderate-to-severe or severe functional mitral regurgitation (FMR) treated by either medical treatment (MT) only TMVrMC+MT by meta-analysis.

Methods and results
By systematic search of bibliographic databases, we evaluated publications comparing heart failure patients with FMR treated by MT only versus treatment by MT combined with TMVrMC. Studies with a minimum of 25 enrolled patients and a follow/up period of at least 12 months were deemed eligible for this meta-analysis. We identified n=7 studies enrolling 2,884 HFrEF patients, divided into two study arms: TMVrMC+MT (n=1,618), versus FMR patients receiving MT only (n=1,266). At 12 months, there was a significant reduction in all-cause mortality favoring TMVR+MT (OR: 0.67; CI 95% 0.55–0.81), as well as a reduction of unplanned rehospitalizations (OR: 0.69; 95%; CI 0.53–0.89), compared with the MT only patients. At 24 months, there was a significant reduction of all-cause mortality in the TMVrMC+MT patient group (OR: 0.50; CI: 95%: 0.38–0.66; p<0.001). TMVrMC+MT was associated with significantly lower rates of unplanned re-admissions for heart failure compared with MT only at 12 months (OR: 0.69; 95% CI: 0.53–0.89; p<0.001) and at 24 months (OR: 0.53; 95% CI: 0.39–0.71; p<0.001). In one publication, a survival benefit of TMVrMC+MT over MT alone was shown at 5 years post intervention (HR: 0.75; 95% CI: 0.69–0.94; p=0.012) after weighting for propensity score and controlling for age.

Conclusions
This meta-analysis on n=2,884 patients with moderate-to-severe or severe FMR reveals that TMVrMC+MT, as compared with MT alone, is associated with a significant reduction of rehospitalizations and improvement of survival. These data imply additional evidence for TMVrMC in eligible heart failure patients with relevant FMR, which might be important for an update of the corresponding guidelines.
1423Adherence to triple component antihypertensive regimen is higher in single-pill combination than two-pill regimen: data from a randomized controlled trial using medication event monitoring system
Authors: Sung J , Ahn K T , Cho B R , Lee S Y , Kim B J , Kim D K , Park J I , Lee W S 
Published: October 2019

Abstract

Background
Simplicity of regimen is known to be an important determinant of medication adherence and using single-pill combination (SPC) in hypertension treatment resulted in better adherence and persistence than free-equivalent combination. However, this finding has been studied only in dual-component antihypertensive treatments and in observational studies using medication possession ratio as an index of adherence. Medication event monitoring system (MEMS) is considered to be the gold standard in estimating medication adherence.

Purpose
To investigate the superiority in adherence of triple-component SPC compared to equivalent two-pill regimen using MEMS

Methods
This is a multi-center open-label randomized controlled trial. Inclusion criteria were hypertensive patients whose clinic blood pressure is not adequately controlled (systolic >140 mmHg or diastolic >90 mmHg) with combination antihypertensive regimen comprising two of three classes (angiotensin receptor blocker, calcium channel blocker and thiazide diuretics) for at least 4 weeks. Eligible patients were randomized either to single-pill (triple-component SPC, olmesartan/amlodipine/ hydrochlorothiazide 20/5/12.5 mg) or two-pill (dual-component SPC + one free pill, olmesartan/hydrochlorothiazide 20/12.5 mg + amlodipine 5 mg) groups and maintained for 12 weeks. Medications were dispensed in MEMS. Primary outcomes were the difference of percentage of dose taken (PDT) and percentage of days with prescribed dose taken correctly (PDTc) between single- and two-pill therapy, calculated from MEMS data.

Results
From 8 hospitals, 146 hypertensive patients were randomized into single- and two-pill groups. Final analysis was done in 65 and 66 patients in each group from which adherence index could be obtained. Baseline clinical characteristics of the two groups were not different. The single-pill group had significantly higher PDT and PDTc compared to the two-pill group. (median (25–75 percentile) (%), PDT 95.1 (87.9 - 100.0) vs 91.2 (79.8 - 96.5); PDTc 93.1 (79.8 - 96.5) vs 91.3 (70.7 - 96.4), p = both 0.04, by Wilcoxon rank sum test)
Percent dose taken

Conclusion
Single-pill combination of triple-component antihypertensive regimen showed superior adherence compared to equivalent two-pill therapy. Reducing pill burden by using SPC is a relevant strategy to enhance the adherence to multi-drug antihypertensive therapy.

Acknowledgement/Funding
Daiichi-Sankyo
2131Pragmatic clinical trials in cardiovascular medicine: trends over time in major medical journals
Authors: Sepehrvand N , Alemayehu W , Das D , Gupta A K , Gouda P , Ghimire A , Du A X , Hatami S , Babadagli H E , Verma S , Kashour Z , Ezekowitz J A 
Published: October 2019

Abstract

Background
Pragmatic trials provide results that may be more applicable to the population in which the intervention will be eventually applied and are discussed extensively in the current healthcare environment. The aim of this study was to investigate how pragmatic or explanatory cardiovascular (CV) randomized controlled trials (RCT) are, if this was changing over time, and if they were more or less likely to meet their primary endpoint.

Methods
Using the six top-ranked (based on impact factors) medical and CV journals, all CV-related RCTs that were published during the years of 2000, 2005, 2010 and 2015 were identified, data extracted and reviewed by 2 adjudicators. The PRECIS-2 tool was used to evaluate the level of pragmatism. PRECIS-2 uses a 5-point ordinal scale (ranging from very pragmatic to very explanatory) across 9 domains of trial design, including eligibility, recruitment, setting, organization, intervention delivery, intervention adherence, follow-up, primary outcome, and analysis. A higher score indicates a more pragmatic score on an individual domain, and aggregated scores are a simplified formula across all domains. Cohen's D was used to quantify the mean difference relative to the variation.

Results
There were 616 RCTs, distributed evenly over the 2 decades, and 64% achieved their primary endpoint. The mean (±SD) PRECIS-2 score was 3.26±0.70 among 616 included RCTs. The level of pragmatism increased over time from a score of 3.07±0.74 in 2000 to 3.47±0.67 in 2015 (p<0.0001 for trend; Cohen's D relative effect size 0.57). The increase in pragmatism occurred mainly in the domains of eligibility, setting, intervention delivery, and primary endpoint (Figure). PRECIS-2 score was higher for neutral trials than those with positive results (p=0.0015) and in phase III/IV trials as compared to phase I/II trials (p<0.0001) (Figure). Furthermore, trials that involve more sites, with larger sample sizes, longer follow-ups, and those with mortality as the primary endpoint were found to be more pragmatic. There was no difference in the level of pragmatism between different sources of funding (public, industry, or both; p=0.52).
Study characteristics and pragmatism

Conclusion
The PRECIS-2 tool can be used for appraising trials to assess their placement in the pragmatic-explanatory continuum. The level of pragmatism increased over time in CV trials. Greater focus on the design and delivery of CV trials will be required for the broad application.

Acknowledgement/Funding
Dr. Sepehrvand receives scholarship from Alberta Innovates Health Solutions.
2424Long-term outcome of patients with biopsy-proven viral myocarditis: 12-year results from a late gadolinium enhancement cardiac magnetic resonance study
Authors: Seitz A , Greulich S , Ebadi N , Gruen S , Klingel K , Gawaz M P , Sechtem U , Bekeredjian R , Mahrholdt H 
Published: October 2019

Abstract

Purpose
Myocarditis is a common cardiac disease that is associated with significant mortality as demonstrated by several studies. Late gadolinium enhancement (LGE) by cardiac magnetic resonance imaging (CMR) is a valuable tool for risk stratification of patients with suspected myocarditis. Previous studies using CMR-LGE have reported a good negative predictive value over follow-up periods of 4–6 years, while its positive predictive value was only modest. However, there is a lack of data regarding the long-term prognosis (>10 years) of these patients. This study reports an extended long-term follow-up of a large cohort of patients with biopsy-proven viral myocarditis.

Methods
At initial presentation, all patients underwent endomyocardial biopsy and CMR for the work-up of suspected myocarditis or unclear cardiomyopathy and had evidence of virus in PCR analyses. The primary endpoints were: all-cause death, cardiac death, and the occurrence of sudden cardiac death (SCD).

Results
183 patients with biopsy-proven viral myocarditis were followed for a median of 11.5 years. At baseline, patients were 52 years old, 31% were females, and the median ejection fraction was moderately reduced (44%). Initial CMR assessment revealed LGE in 101 (55%) patients, while 82 (45%) patients had LGE-negative CMR. During the follow-up period, the following endpoints occurred in the overall cohort: all-cause death (n=71, 39%), cardiac death (n=50, 27%) and SCD (n=20, 11%). Most importantly, only a single LGE-negative patient experienced a SCD during this 12-year follow-up, while all other SCDs occurred in patients with LGE-positive CMR (1% vs. 19%, p<0.001). Consequently, the negative predictive value (NPV) of normal CMR-LGE regarding SCD was 98%. In addition, cardiac mortality (12% vs. 40%, p<0.001, NPV=88%) and all-cause mortality (20% vs. 54%, p<0.001, NPV=79%) were significantly lower in patients without LGE.

Conclusion
This cohort of biopsy-proven viral myocarditis demonstrates substantial mortality (39% in 11.5 years). However, absence of LGE on CMR was associated with favorable prognosis. This was applicable regarding all-cause and cardiac mortality, but most importantly with regard to SCD with a NPV of 98% over almost 12 years median follow-up.

Acknowledgement/Funding
This work was funded by the Robert-Bosch-Stiftung, Stuttgart, Germany and the Berthold-Leibinger-Stiftung, Ditzingen, Germany.