Current guidelines recommend intensified platelet inhibition by prasugrel or ticagrelor in patients with unstable angina (UA) or non-ST-segment elevation (NSTE) myocardial infarction (MI).
This study ...sought to investigate the benefits and risks of ticagrelor as compared with prasugrel in patients with non-ST-segment elevation acute coronary syndromes (NSTE-ACS) and planned invasive management.
This post hoc analysis combines the pre-specified subgroups of UA and NSTEMI of the randomized ISAR-REACT 5 trial. It included 1,179 patients assigned to ticagrelor and 1,186 assigned to prasugrel. Ticagrelor was started immediately after randomization and prasugrel after coronary angiography. The primary endpoint was a composite of death, MI, or stroke during 1-year follow-up, and the safety endpoint was Bleeding Academic Research Consortium class 3–5.
The primary endpoint was reached in 101 (8.7%) patients in the ticagrelor and in 73 (6.3%) patients in the prasugrel group (hazard ratio HR: 1.41; 95% confidence interval CI: 1.04 to 1.90). The HR for all-cause death was 1.43 (95% CI: 0.93 to 2.21) and that for MI 1.43 (95% CI: 0.94 to 2.19). The safety endpoint occurred in 49 (5.2%) patients in the ticagrelor and in 41 (4.7%) patients in the prasugrel group (HR: 1.09; 95% CI: 0.72 to 1.65). Landmark analysis revealed persistence of the efficacy advantage with prasugrel after the first month.
In patients with NSTE-ACS, we found that prasugrel was superior to ticagrelor in reducing the combined 1-year risk of death, MI, and stroke without increasing the risk of bleeding. Due to the post hoc nature of the analysis, these findings need confirmation by further studies. (Prospective, Randomized Trial of Ticagrelor Versus Prasugrel in Patients With Acute Coronary Syndrome; NCT01944800)
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The ACURATE neo transcatheter heart valve has demonstrated a balanced profile with low rates of permanent pacemaker implantation, low risk of coronary obstruction, and favorable hemodynamic ...properties whilst having an acceptable rate of ≥moderate paravalvular leakage (PVL). Here, we report in-hospital results and assess the learning curve for implantation of the ACURATE neo device in a large, single-center cohort. The cohort of this retrospective, observational study comprised 1,000 consecutive patients with severe aortic stenosis who underwent transfemoral transcatheter aortic valve implantation using the ACURATE neo prosthesis between May 2012 and December 2019. We determined procedural outcomes with emphasis on PVL and analyzed the learning curve. The median age was 81.9 years IQR 78.8; 85.1, and the Euroscore II was 4.2% IQR 2.7; 7.3. The rate of PVL ≥moderate measured by echocardiography at discharge was 3.7% (37 of 988). We observed a learning curve, with a decline in ≥moderate PVL from 6.7% in the first quartile to 0.8% in the last quartile, that was related to better patient selection, more oversizing, and consideration of the amount and distribution of aortic valve calcification.
In this thus far largest single-center experience using the ACURATE neo prosthesis, we demonstrate that after completing a learning curve and observation of precepts that include patient selection, careful sizing, and procedural aspects, the rate of ≥moderate PVL may be reduced to <1%.
•We observed a clear learning curve for the use of the ACURATE neo prosthesis.•Rates of ≥moderate paravalvular leakage declined from 7.4% to 0.8% in the last quartile.•A good patient selection and proper sizing are key for improved outcomes.
The aim of this study was to perform a comprehensive analysis of factors that affect procedural outcomes of transcatheter aortic valve replacement using the ACURATE neo prosthesis (Symetis/Boston, ...Ecublens, Switzerland).
Predictors of procedural outcomes using the ACURATE neo prosthesis are poorly understood.
A total of 500 patients underwent transfemoral aortic valve replacement with the ACURATE neo prosthesis. Device landing zone calcification was stratified as severe, moderate, or mild. Anatomic and procedural predictors of second-degree or greater paravalvular leakage and permanent pacemaker implantation were assessed.
Post-procedural second-degree or greater paravalvular leakage was more frequent with increasing device landing zone calcification (mild 0.8% vs. moderate 5.0% vs. severe 13.0%; p < 0.001), whereas permanent pacemaker implantation was independent of device landing zone calcification. More severe periannular calcification (odds ratio OR: 1.007; 95% confidence interval CI: 1.003 to 1.010; p < 0.001), less oversizing (OR: 0.867; 95% CI: 0.773 to 0.971; p = 0.014), the presence of annular plaque protrusions (OR: 2.756; 95% CI: 1.138 to 6.670; p = 0.025), and aortic movement of the delivery system after full deployment (OR: 5.593; 95% CI: 1.299 to 24.076; p = 0.02), and sinotubular junction height (OR: 1.156; 95% CI: 1.007 to 1.328; p = 0.04) independently predicted second-degree or greater paravalvular leakage. Predictors of permanent pacemaker implantation were pre-existing right bundle branch block (OR: 3.122; 95% CI: 1.261 to 7.731; p = 0.01) and more oversizing (OR: 1.111; 95% CI: 1.009 to 1.222; p = 0.03).
Successful transcatheter aortic valve replacement using the ACURATE neo device predominantly depends on careful patient selection with appropriate oversizing and taking into account the individual anatomy and calcium distribution of the aortic root.
Data on long-term outcomes of cryoballoon ablation for treatment of atrial fibrillation (AF) are sparse. Here, we report the first 5-year follow-up results and predictors of outcome for pulmonary ...vein isolation (PVI) using the second-generation cryoballoon (CB-Adv) in patients with symptomatic AF.
For this prospective observational study, we enrolled 178 patients with paroxysmal (132/178 74.2% patients) or persistent AF who underwent PVI with CB-Adv at our institution during 2012. Clinical success was defined as freedom from AF, atrial flutter or atrial tachycardia recurrence >30-s following the 3-month blanking period. Follow-up data were collected during outpatient clinic visits and included Holter-ECG recordings. The impacts of several variables on outcome were evaluated by means of univariate and multivariate analyses and Cox proportional hazards regression models.
PVI was sufficient in restoring and maintaining sinus rhythm in 59.0% (n = 105) of patients (paroxysmal AF: 81/132 (61.4%) patients; persistent AF: 24/46 (52.2%) patients, P = 0.20). The median procedure and fluoroscopy times were 126 (interquartile range 114/150) and 20 (16/26) min, respectively. Cox regression analysis showed that left atrial area ≤21 cm2 and the absence of diabetes independently predicted outcome.
Sinus rhythm was maintained in a substantial proportion of patients even 5 years after CB-Adv ablation. Patients with a non-enlarged left atrium without diabetes had the best outcome.
•We present the first reportof 5-year outcome after pulmoary vein isolation using the second-generationcryoballoon.•After a single procedure,59.0% of the patients maintained sinus rhythm during long-term follow-up.•Patients with a left atrial area ≤21 cm2 without diabetes showed the best outcome.•Ongoing surveillance is warranted, even if pulmonary vein isolation is deemed initially successful.
Objectives This study sought to evaluate exact release kinetics of microRNAs (miRNAs) in acute myocardial infarction (AMI). Background miRNAs may be useful as novel biomarkers in patients with ...cardiovascular disease, although it is difficult to establish the detailed release kinetics of miRNAs in patients with AMI. Methods We analyzed the release kinetics of circulating cardiac-specific (miR-21, miR-208a) and muscle-enriched (miR-1, miR-133a) miRNAs using the TaqMan polymerase chain reaction in patients with hypertrophic obstructive cardiomyopathy who were undergoing transcoronary ablation of septal hypertrophy (TASH), a procedure mimicking AMI. Consecutive patients (n = 21) undergoing TASH were included. Serum samples were collected prior to and at 15, 30, 45, 60, 75, 90, and 105 min and 2, 4, 8, and 24 h after TASH. Results Circulating concentrations of miR-1 were significantly increased (>3-fold; p = 0.01) after 15 min, with a peak after 75 min (>60-fold; p < 0.001). The miR-21 concentrations were not increased at any time point. Concentrations of miR-133a were significantly increased at 15 min (2.9-fold; p < 0.001) and reached a plateau between 75 and 480 min (>50-fold change). The miR-208a concentrations were elevated at 105 min (>2-fold; p = 0.01), without a further increase. Conclusions miR-1, miR-133a, and miR-208a were continuously increased during the first 4 h after the induction of MI. In particular, miR-1 and miR-133a were significantly increased at early time points. These results demonstrate the release kinetics of miRNAs, which are helpful for developing their potential use as biomarkers in patients with acute coronary syndromes.
This study compared image quality and evaluability of coronary artery disease (CAD) in routine preparatory imaging for transcatheter aortic valve replacement using 64-slice (first-generation) to ...192-slice (third-generation) dual-source computed tomography(DSCT).
The CT data sets of 192 patients (122 women, median age 82 y) without severe renal dysfunction or known CAD were analyzed retrospectively. Half were examined using first-generation DSCT (June 2014 to February 2016) and the other half with third-generation DSCT (April 2016 to April 2017). Per protocol, contrast material (110 110 to 120 vs. 70 70 to 70 mL, P <0.001) and radiation dose of multiphasic retrospectively gated thoracic CT angiography (dose-length-product, 1001 707 to 1312 vs. 727 474 to 1369 mGy×cm, P <0.001) were significantly lower with third-generation DSCT. Significant CAD was defined as CAD-RADS ≥4 by CT. Invasive coronary angiography served as the reference standard (CAD is defined as ≥70% stenosis or fractional flow reserve ≤0.80).
In comparison with first-generation DSCT, third-generation DSCT showed significantly better subjective (3 interquartile range 2 to 3 vs. 4 3 to 4.25 on a 5-point scale, P <0.001) and objective image quality (signal-to-noise ratio of left coronary artery 12.8 9.9 to 16.4 vs. 15.2 12.4 to 19.0, P <0.001). Accuracy (72.9% vs. 91.7%, P =0.001), specificity (59.7% vs. 88.3%, P <0.001), positive (61.0% vs. 83.3%, P <0.001), and negative predictive value (91.9% vs. 98.2%, P =0.045) for detecting CAD per-patient were significantly better using third-generation DSCT, while sensitivity was similar (92.3% vs. 97.2%, P =0.129).
Coronary artery evaluation with CT angiography before TAVI is feasible in selected patients. Compared with first-generation DSCT, state-of-the-art third-generation DSCT technology is superior for this purpose, allowing for less contrast medium and radiation dose while providing better image quality and improved diagnostic performance.
Background
Fibroblast growth factor 23 (FGF-23) has been associated with left ventricular hypertrophy (LVH) and heart failure. However, its role in right ventricular (RV) remodeling and RV failure is ...unknown. This study analyzed the utility of FGF-23 as a biomarker of RV function in patients with pulmonary hypertension (PH).
Methods
In this observational study, FGF-23 was measured in the plasma of patients with PH (
n
= 627), dilated cardiomyopathy (DCM,
n
= 59), or LVH with severe aortic stenosis (
n
= 35). Participants without LV or RV abnormalities served as controls (
n
= 36).
Results
Median FGF-23 plasma levels were higher in PH patients than in healthy controls (
p
< 0.001). There were no significant differences between PH, DCM, and LVH patients. Analysis across tertiles of FGF-23 levels in PH patients revealed an association between higher FGF-23 levels and higher levels of NT-proBNP and worse renal function. Furthermore, patients in the high-FGF-23 tertile had a higher pulmonary vascular resistance (PVR), mean pulmonary artery pressure, and right atrial pressure and a lower cardiac index (CI) than patients in the low tertile (
p
< 0.001 for all comparisons). Higher FGF-23 levels were associated with higher RV end-diastolic diameter and lower tricuspid annular plane systolic excursions (TAPSE) and TAPSE/PASP. Receiver operating characteristic analysis revealed FGF-23 as a good predictor of RV maladaptation, defined as TAPSE < 17 mm and CI < 2.5 L/min/m
2
. Association of FGF-23 with parameters of RV function was independent of the glomerular filtration rate in regression analysis.
Conclusion
FGF-23 may serve as a biomarker for maladaptive RV remodeling in patients with PH.
Graphic abstract
Abstract
Aims
To evaluate the impact of an experimental strategy 23-month ticagrelor monotherapy following 1-month dual antiplatelet therapy (DAPT) vs. a reference regimen (12-month aspirin ...monotherapy following 12-month DAPT) after complex percutaneous coronary intervention (PCI).
Methods and results
In the present post hoc analysis of the Global Leaders trial, the primary endpoint composite of all-cause death or new Q-wave myocardial infarction (MI) at 2 years was assessed in patients with complex PCI, which includes at least one of the following characteristics: multivessel PCI, ≥3 stents implanted, ≥3 lesions treated, bifurcation PCI with ≥2 stents, or total stent length >60 mm. In addition, patient-oriented composite endpoint (POCE) (composite of all-cause death, any stroke, any MI, or any revascularization) and net adverse clinical events (NACE) composite of POCE or Bleeding Academic Research Consortium (BARC) Type 3 or 5 bleeding were explored. Among 15 450 patients included in this analysis, 4570 who underwent complex PCI had a higher risk of ischaemic and bleeding events. In patients with complex PCI, the experimental strategy significantly reduced risks of the primary endpoint hazard ratio (HR): 0.64, 95% confidence interval (CI): 0.48–0.85 and POCE (HR: 0.80, 95% CI: 0.69–0.93), but not in those with non-complex PCI (Pinteraction = 0.015 and 0.017, respectively). The risk of BARC Type 3 or 5 bleeding was comparable (HR: 0.97, 95% CI: 0.67–1.40), resulting in a significant risk reduction in NACE (HR: 0.80, 95% CI: 0.69–0.92; Pinteraction = 0.011).
Conclusion
Ticagrelor monotherapy following 1-month DAPT could provide a net clinical benefit for patients with complex PCI. However, in view of the overall neutral results of the trial, these findings of a post hoc analysis should be considered as hypothesis generating.
Purpose
Sex differences in blood pressure (BP) regulation at rest have been attributed to differences in vascular function. Further, arterial stiffness predicts an exaggerated blood pressure response ...to exercise (BPR) in healthy young adults. However, the relationship of vascular function to the workload-indexed BPR and potential sex differences in athletes are unknown.
Methods
We examined 47 male (21.6 ± 1.7 years) and 25 female (21.1 ± 2 years) athletes in this single-center pilot study. We assessed vascular function at rest, including systolic blood pressure (SBP). Further, we determined the SBP/W slope, the SBP/MET slope, and the SBP/W ratio at peak exercise during cycling ergometry.
Results
Male athletes had a lower central diastolic blood pressure (57 ± 9.5 vs. 67 ± 9.5 mmHg,
p
< 0.001) but a higher central pulse pressure (37 ± 6.5 vs. 29 ± 4.7 mmHg,
p
< 0.001), maximum SBP (202 ± 20 vs. 177 ± 15 mmHg,
p
< 0.001), and ΔSBP (78 ± 19 vs. 58 ± 14 mmHg,
p
< 0.001) than females. Total vascular resistance (1293 ± 318 vs. 1218 ± 341 dyn*s/cm
5
,
p
= 0.369), pulse wave velocity (6.2 ± 0.85 vs. 5.9 ± 0.58 m/s,
p
= 0.079), BP at rest (125 ± 10/76 ± 7 vs. 120 ± 11/73.5 ± 8 mmHg,
p
> 0.05), and the SBP/MET slope (5.7 ± 1.8 vs. 5.1 ± 1.6 mmHg/MET,
p
= 0.158) were not different. The SBP/W slope (0.34 ± 0.12 vs. 0.53 ± 0.19 mmHg/W) and the peak SBP/W ratio (0.61 ± 0.12 vs. 0.95 ± 0.17 mmHg/W) were markedly lower in males than in females (
p
< 0.001).
Conclusion
Male athletes displayed a lower SBP/W slope and peak SBP/W ratio than females, whereas the SBP/MET slope was not different between the sexes. Vascular functional parameters were not able to predict the workload-indexed BPR in males and females.
Introduction
Data on long‐term outcomes of cryoballoon (CB) ablation for treatment of persistent atrial fibrillation (AF) are sparse. Here, we report the first 3‐year follow‐up results and predictors ...of success for catheter ablation using the second‐generation CB in patients with persistent AF.
Methods and results
For this prospective observational study, we enrolled 101 patients ablated with the second‐generation CB at our institution. The endpoint was the first documented recurrence (> 30 seconds) of AF, atrial flutter, or atrial tachycardia after a 3‐month blanking period. Follow‐up data were collected during outpatient clinic visits and included Holter‐ECG recordings. The impact of several variables on recurrence was evaluated by means of univariate and multivariate analyses and Cox proportional hazards regression models.
After a median follow‐up of 37 (31 of 42) months, recurrence was documented in 30 patients (29.7%). The median procedure and fluoroscopy times were 120 (102 of 147) and 20 (16 of 27) minutes, respectively. Phrenic nerve palsy occurred in 2.0% of the patients. Among the 30 patients who experienced recurrence, 16 underwent repeat ablation in radiofrequency technique. Cox regression analysis showed that left atrial area > 21 cm2 and AF history duration > 2 years independently predicted recurrence.
Conclusions
Sinus rhythm was maintained in a substantial proportion of patients even 3 years after CB ablation. Patients with a nonenlarged left atrium and short AF history had the best outcome.
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