Search

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.

Objectives: To assess feasibility and short-term clinical outcomes associated with resorbable magnesium scaffold (RMS) implantation in the setting of primary percutaneous coronary intervention for ST-segment elevation myocardial infarction (STEMI)., Background: RMS implantation has demonstrated favorable clinical outcomes in stable coronary artery disease patients. However, to date, data are lacking in the setting of STEMI., Methods: This is a single-center prospective non-randomized pilot study. Patients admitted for STEMI were enrolled according to prespecified inclusion and exclusion criteria. The primary endpoint was device-oriented composite endpoint (DOCE), including cardiac death, target-vessel myocardial infarction, and target-lesion revascularization (TLR) within 30 days of the index procedure. Secondary endpoints were procedural success, any probable/definite scaffold thrombosis, and DOCE at subsequent follow-up., Results: From December 1, 2016 to October 30, 2017, a total of 18 patients were included. Follow-up data were available for 17 patients (94%). There was no primary endpoint event. Procedural success was 100%. Patients were followed for a median of 153 days (range, 59-326 days). Over that extended follow-up period, 1 case of TLR occurred 102 days after the index procedure. There was no case of definite or probable scaffold thrombosis., Conclusions: This pilot study is the first to assess feasibility and clinical outcomes associated with RMS implantation in selected STEMI patients. The results seem reassuring, with favorable short-term clinical outcomes and absence of definite/probable scaffold thrombosis, and should prompt further research including randomized controlled trials evaluating RMS implantation in the setting of STEMI.

Several recent reports have described the occurrence of longitudinal stent deformation (LSD, defined as the distortion or shortening of a stent along the longitudinal axis), following its successful deployment. However, few reports have described LSD prior to any stent deployment. This previously unrecognized complication is the result of modifications to stent design. It has been noted that the new-generation stent platforms have a reduced number of connectors, which in turn causes a reduction in longitudinal stent strength. To corroborate previous findings by our lab and others (Vijayvergiya et al, 2013), we describe here two cases of LSD prior to stent deployment that occurred due to crushing of the proximal stent edge by the guide catheter while attempting to withdraw the crimped stent. In addition, we discuss the associated risk factors, such as the length of the stent, and specific management strategies, including technical guidelines and use of fluoroscopic guidance for maneuvering the stent during the procedure.

Anatomic variations during transradial (TR) procedures are relatively common and represent a significant cause of technical failure, even for experienced radial operators. In this study, we present an interesting alternative technique to overcome these anatomical anomalies. A significant amount of TR procedures in various and challenging anatomical conditions were successfully completed with the use of a 0.014″ hydrophilic coronary guidewire.

During provisional stenting of a bifurcation lesion, recrossing into the side branch (SB) can be sometimes difficult or even impossible, especially when the SB lumen is compromised by a dissection. This report describes a rescue technique that can help to restore flow and regain access to the SB lumen in case of total SB occlusion after main vessel stent placement.