OCT provides unique insights in patients with SCAD that allow an early diagnosis and adequate management. Most of these findings are undetectable by angiography.
AimsCardiopoietic cells, produced through cardiogenic conditioning of patients’ mesenchymal stem cells, have shown preliminary efficacy. The Congestive Heart Failure Cardiopoietic Regenerative Therapy (CHART-1) trial aimed to validate cardiopoiesis-based biotherapy in a larger heart failure cohort.Methods and resultsThis multinational, randomized, double-blind, sham-controlled study was conducted in 39 hospitals. Patients with symptomatic ischaemic heart failure on guideline-directed therapy (n = 484) were screened; n = 348 underwent bone marrow harvest and mesenchymal stem cell expansion. Those achieving > 24 million mesenchymal stem cells (n = 315) were randomized to cardiopoietic cells delivered endomyocardially with a retention-enhanced catheter (n = 157) or sham procedure (n = 158). Procedures were performed as randomized in 271 patients (n = 120 cardiopoietic cells, n = 151 sham). The primary efficacy endpoint was a Finkelstein–Schoenfeld hierarchical composite (all-cause mortality, worsening heart failure, Minnesota Living with Heart Failure Questionnaire score, 6-min walk distance, left ventricular end-systolic volume, and ejection fraction) at 39 weeks. The primary outcome was neutral (Mann–Whitney estimator 0.54, 95% confidence interval [CI] 0.47–0.61 [value > 0.5 favours cell treatment], P = 0.27). Exploratory analyses suggested a benefit of cell treatment on the primary composite in patients with baseline left ventricular end-diastolic volume 200–370 mL (60% of patients) (Mann–Whitney estimator 0.61, 95% CI 0.52–0.70, P = 0.015). No difference was observed in serious adverse events. One (0.9%) cardiopoietic cell patient and 9 (5.4%) sham patients experienced aborted or sudden cardiac death.ConclusionThe primary endpoint was neutral, with safety demonstrated across the cohort. Further evaluation of cardiopoietic cell therapy in patients with elevated end-diastolic volume is warranted.
In DM patients with coronary artery disease taking maintenance aspirin and clopidogrel therapy, impaired renal function is associated with reduced clopidogrel-induced antiplatelet effects and a greater prevalence of HPPR.
OCT has a moderate diagnostic efficiency in identifying hemodynamically severe coronary stenoses. Although OCT seems slightly superior to IVUS for this purpose (particularly in vessels <3 mm), its low specificity precludes its use as a substitute of FFR for functional stenosis assessment.
The readmission burden after TAVR in an all-comers population was high. Nearly one-fifth of the patients were readmitted early after hospital discharge, increasing the risk of mortality at follow-up. Reasons for readmission were split between noncardiac and cardiac causes, with respiratory causes and heart failure as the main diagnoses in each group, respectively. Whereas early readmissions were mainly related to periprocedural bleeding events, most late readmissions were secondary to baseline patient comorbidities. These results underscore the importance of and provide the basis for implementing specific preventive measures to reduce readmission rates after TAVR.
Background:
Stroke remains one of the most devastating complications of transcatheter aortic valve implantation (TAVI). The aim of this study was to identify the incidence, timing, temporal trends, and predictors of stroke after TAVI and evaluate the outcomes of patients with stroke.
Methods and Results:
The CENTER-Collaboration is an international collaboration consisting of 3 national registries and 7 local registries or prospective clinical trials, selected through a systematic review. Accordingly, a total of 10 982 patients undergoing transfemoral TAVI between 2007 and 2018 were included in the current patient-level pooled analyses. A total of 261 patients (2.4%) experienced stroke during the first month after TAVI. The median time between TAVI and stroke was 1 day (interquartile range, 0–6 days). The stroke rate was comparable in procedures performed in the early years of TAVI (2007–2012) to those in the more recent years of TAVI (2013–2018; both 2.4%;
P
=1.0). Independent predictors of stroke at 30 days were a history of cerebrovascular events (odds ratio, 2.2; 95% CI, 1.4–3.6;
P
=0.0012) and a glomerular filtration rate of <30 mL/min per 1.73 m
2
(odds ratio, 1.7; 95% CI, 1.0–2.8;
P
=0.05). Stroke occurring within the first 30 days after TAVI was associated with a 6-fold increase of 30-day mortality (odds ratio, 6.0; 95% CI, 4.4–8.1;
P
<0.001). Moreover, patients with stroke more frequently had documented new-onset atrial fibrillation (16% versus 3%;
P
<0.001) and major or life-threatening bleedings (12% versus 7%;
P
=0.002) at 30-day follow-up.
Conclusions:
In this large, global, patient-level analysis, the incidence of stroke after transfemoral TAVI was 2.4%. Prior cerebrovascular events and a low glomerular filtration rate independently predicted the occurrence of stroke after TAVI. The occurrence of stroke after TAVI was associated with a strikingly 6-fold increase of 30-day mortality; additionally, there was a 5-fold higher rate of new-onset atrial fibrillation in patients with stroke.
Clinical Trial Registration:
URL:
https://www.clinicaltrials.gov
. Unique identifier: NCT03588247.
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