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The infusion of bone marrow–derived progenitor cells into the infarct-related coronary artery after an acute myocardial infarction was associated with an absolute increase in the ejection fraction of 5.5%. Determining whether this modest improvement in ventricular function will translate into a long-term clinical benefit will require larger trials with longer follow-up. The infusion of bone marrow–derived progenitor cells into the infarct-related coronary artery after an acute myocardial infarction was associated with an absolute increase in the ejection fraction of 5.5%. Prompt reperfusion of the infarct-related coronary artery has considerably improved the clinical outcome in patients with acute myocardial infarction. 1 Although contemporary reperfusion strategies using stent implantation and aggressive inhibition of platelet aggregation have been shown to increase myocardial salvage, 2 improvements in global left ventricular function are rather modest, despite the use of optimal reperfusion therapy. 3 , 4 Heart failure that develops after infarction remains a major cause of morbidity and mortality. 5 , 6 Experimental studies suggested that intravascular or intramyocardial administration of progenitor cells derived from bone marrow (BMC) or blood may contribute to functional regeneration of infarcted myocardium and enhance neovascularization . . .

Intracoronary infusion of progenitor cells derived from bone marrow in patients with healed myocardial infarction resulted in moderate but significant improvement in global and regional ventricular function. Circulating progenitor cells were less effective. The mechanisms underlying the benefit are uncertain. This line of research is in its early stages but may hold promise for the future. Intracoronary infusion of progenitor cells derived from bone marrow in patients with healed myocardial infarction resulted in moderate but significant improvement in global and regional ventricular function. Chronic heart failure is common, and its prevalence continues to increase. 1 Ischemic heart disease is the principal cause of heart failure. 2 Although myocardial salvage due to early reperfusion therapy has significantly reduced early mortality rates, 3 postinfarction heart failure resulting from ventricular remodeling remains a problem. 4 One possible approach to reversing postinfarction heart failure is enhancement of the regeneration of cardiac myocytes as well as stimulation of neovascularization within the infarcted area. Initial clinical pilot studies have suggested that intracoronary infusion of progenitor cells is feasible and may beneficially affect postinfarction remodeling processes in patients with acute myocardial infarction. 5 – 9 However, . . .

Serial cardiac magnetic resonance imaging (CMR) is the reference standard for evaluating left ventricular function, wall motion, and infarct size in patients with acute myocardial infarction, as well as remodeling during follow-up. The cardiac CMR substudy of the randomized multicenter REPAIR-AMI trial (Reinfusion of Enriched Progenitor cells And Infarct Remodeling in Acute Myocardial Infarction study) aimed at gaining insight into postinfarction left ventricular remodeling processes. Consecutive patients with ST-segment elevation myocardial infarction and primary percutaneous coronary intervention were enrolled (n = 204) and randomly assigned to either stem cell therapy (bone marrow-derived progenitor cells [BMC]) or placebo after bone marrow aspiration. In the magnetic resonance imaging substudy, 54 patients completed serial CMR (baseline, 4 and 12 months, respectively) after enrollment (27 BMC, 27 placebo). Image analysis was performed at a central core laboratory. There were no significant differences between the 2 groups with respect to global ejection fraction (EF), end-diastolic volume (EDV), and end-systolic volume (ESV) at baseline. At 12 months, the treatment effect of BMC infusion on EF amounted to 2.8 absolute percentage points ( P = .26), the progression of EDV at 12 months was less in the BMC group (treatment effect 14 mL, P = .12), and unlike placebo, ESV did not increase (absolute treatment effect 13 mL, P = .08), respectively. In patients with a baseline EF < median (EF ≤ 48.9%), BMC administration was associated with a significantly improved EF (+6.6%, P = .01), reduced EDV increase (treatment effect 29.1 mL, P = .02), and abrogation of ESV increase (treatment effect 29.4 mL, P = .01) after 12 months, respectively. Intracoronary administration of BMC additionally improved left ventricular function in patients with impaired left ventricular function after ST-segment elevation myocardial infarction despite optimal “state-of-the-art” reperfusion and pharmacologic treatment on 1-year follow-up and beneficially interfered with adverse postinfarction left ventricular remodeling.

The FIREHAWK is a drug-eluting stent with a fully biodegradable sirolimus-containing polymer coating localised to recessed abluminal grooves on the stent surface. We investigated clinical outcomes with this targeted, low-dose, biodegradable polymer, sirolimus-eluting stent compared with XIENCE durable polymer, everolimus-eluting stents in an all-comers population. The TARGET All Comers study was a prospective, multicentre, open-label randomised non-inferiority trial done at 21 centres in ten European countries. Patients with symptomatic or asymptomatic coronary artery disease and objective evidence of myocardial ischaemia who qualified for percutaneous coronary intervention were randomised 1:1 to undergo implantation of a FIREHAWK or XIENCE. Randomisation was web-based, with random block allocation and stratification by centre and ST elevation myocardial infarction. Outcome assessors were masked to treatment allocation, but treating physicians and patients were not. The primary endpoint was target lesion failure at 12 months, a composite of cardiac death, target vessel myocardial infarction, or ischaemia-driven target lesion revascularisation. The control event rate for XIENCE was assumed to be 7%, the non-inferiority margin was 3.5%, and the primary analysis was in the intention-to-treat population, censoring patients who did not have either an event before 365 days or contact beyond 365 days. Late lumen loss was the primary endpoint of an angiographic substudy designed to investigate the non-inferiority of the FIREHAWK compared with the XIENCE stent. This trial is registered with ClinicalTrials.gov, number NCT02520180. From Dec 17, 2015, to Oct 14, 2016, 1653 patients were randomly assigned to implantation of the FIREHAWK (n=823) or XIENCE (n=830). 65 patients in the FIREHAWK group and 66 in the XIENCE group had insufficient follow-up data and were excluded from the analyses. At 12 months, target lesion failure occurred in 46 (6·1%) of 758 patients in the FIREHAWK group and in 45 (5·9%) of 764 patients in the XIENCE group (difference 0·2%, 90% CI −1·9 to 2·2, pnon-inferiority=0·004, 95% CI −2·2 to 2·6, psuperiority=0·88). There were no differences in ischaemia-driven revascularisation or stent thrombosis rates at 12 months. 176 patients were included in the angiographic substudy, in which in-stent late lumen loss was 0·17 mm (SD 0·48) in the FIREHAWK group and 0·11 mm (0·52) in the XIENCE group (p=0·48), with an absolute difference of 0·05 mm (95% CI −0·09 to 0·18, pnon-inferiority=0·024). In a broad all-comers population of patients requiring stent implantation for myocardial ischaemia, the FIREHAWK was non-inferior to the XIENCE as assessed with the primary endpoint of target lesion failure at 12 months and in-stent late lumen loss at 13 months. The FIREHAWK is a safe and effective alternative stent to treat patients with ischaemic coronary artery disease in clinical practice. Shanghai Microport Medical.

Background Limited data is available for investigating the long-term safety and effects of intracoronary progenitor cell therapy in patients with acute myocardial infarction (AMI). Objective To assess the clinical course, NT-proBNP and MRI data as objective markers of cardiac function of the TOPCARE-AMI patients at 5-year follow-up. Design The TOPCARE-AMI trial was the first randomized study investigating the effects of intracoronary infusion of circulating (CPC) or bone marrow-derived progenitor cells (BMC) in 59 patients with successfully reperfused AMI. Results Five-year follow-up data were completed in 55 patients, 3 patients were lost to follow-up. None of the patients showed any signs of intramyocardial calcification or tumors at 5 years. One patient died during the initial hospitalization, no patient was rehospitalized for heart failure and 16 patients underwent target vessel revascularization (TVR). Only two TVRs occurred later than 1 year after cell administration making it very unlikely that the infused cells accelerate atherosclerotic disease progression. Serum levels of NT-proBNP remained significantly reduced at the 5-year follow-up indicating the absence of heart failure. MRI subgroup analysis in 31 patients documented a persistent improvement of LV ejection fraction (from 46 ± 10% at baseline to 57 ± 10% at 5 years, p  < 0.001)). Simultaneously, there was a reduction ( p  < 0.001) in functional infarct size measured as late enhancement volume normalized to LV mass. However, whereas LV end-systolic volume remained stable, LV end-diastolic volume increased significantly. Conclusions The 5-year follow-up of the TOPCARE-AMI trial provides reassurance with respect to the long-term safety of intracoronary cell therapy and suggests favorable effects on LV function.

Background Observational studies suggest there are gender based differences in the treatment of coronary artery disease, with women receiving evidence based therapy less frequently than suggested by current guidelines. The aim of our study was to evaluate gender based differences in the use of DES. Methods We analysed prospectively collected data from 100704 stent implantations in the PCI registry of the ALKK between 2005 and 2009. Results The usage of DES increased from 16.0 to 43.9%. Although women had smaller vessel sizes, they received DES less often compared to men (28.2 vs. 31.3%), with an adjusted odds ratio of 0.93 (95% confidence interval 0.89-0.97) at the age of 75, and an adjusted odds ratio of 0.89 (95% confidence interval 0.84-0.94) at the age of 80. Conclusion Despite having smaller vessels than men, women were treated less often with DES. These findings apply to women above the age of 75 years. These findings support previous reports, that elderly women with coronary artery disease are treated differently to men.

Early reperfusion of occluded coronary arteries has significantly reduced early mortality and improved the long-term prognosis of patients with an acute myocardial infarction. However, the development of postinfarction heart failure remains a major challenge. Initial experimental studies indicated that mononuclear progenitor cells derived from the bone marrow may contribute to the functional regeneration of freshly infarcted myocardium and increase neovascularization of ischemic areas. A number of clinical pilot trials have now transferred the experimental approach into the clinical arena, aiming at regenerating myocardial function with infusion of bone-marrow-derived progenitor cells in patients after an acute myocardial infarction. While these initial trials using intracoronary infusion of bone-marrow-derived progenitor cells indeed suggested that such a strategy appears to be feasible and safe in patients with an acute myocardial infarction, there is definitely a pressing need for a proof-of-concept study documenting a potentially beneficial effect of progenitor cell therapy on cardiac function.

Objective and background We present a first description of a Heart Team (HT)-guided approach to coronary revascularization and its long-term effect on clinical events after percutaneous coronary intervention (PCI). The HT approach is a structured process to decide for coronary bypass grafting (CABG), PCI or conservative therapy in ad hoc situations as well as in HT conferences. As a hypothesis, during the long-term course after a PCI performed according to HT rules, a low number of late revascularizations, especially CABGs, are expected (F-PCI study). Methods In this monocentric study, the HT approach to an all-comer population was first analyzed and described in general with the help of a database. Next the use of a HT approach was described for a more homogeneous subgroup with newly detected CAD (1.CAD). Those patients in whom the HT decision was PCI (which was a 1.PCI) were then studied with the help of questionnaires for clinical events during a very long-term follow-up. Events were CABG, PCI, diagnostic catheterization (DCath) and death. Results A significant number of patients were presented to HT conferences: 22 % out of all 11,174 catheterizations, 24 % out of all 7867 CAD cases and 35 % out of 3408 1.CAD cases. Most of these patients had multi-vessel disease (MVD). Conference decisions were isolated CABG in 46–66 %, PCI in 10–14 %, valvular surgery in 9–16 %, HTx in 10–21 % (Endstage heart failure candidates for surgery) and conservative therapy (Medical or no therapy, additional diagnostic procedures or no adherence to recommended therapy) in 2–3 %. However, most PCIs, ad hoc and elective, were performed under Heart Team rules, but without conference. During follow-up of 1.PCI patients (Kaplan–Meier analysis), CABG occurred in only 15 % of patients, PCI in 37 % and DCath in 65 %; mortality of any course was 51 %. Mortalities were similar in one-vessel disease and in a population of the same year, matched for age and sex ( p  < 0.057), but mortality was higher in 1.PCI patients with MVD ( p  < 0.001). Beyond 2 years, Kaplan–Meier curves were linear. Conclusion The structured Heart Team approach is an effective tool for ad hoc and conference-based clinical decision-making with a sustained clinical benefit. This is demonstrated in low late CABG (and PCI) rates after a 1.PCI, without elevated mortality. The all-comer population supports the universal value of these data. Stable annual event rates late after PCI suggest a conversion to stable CAD. Heart Team conferences are also important tools in cases of valvular and end-stage heart disease.

BackgroundTranscatheter aortic valve implantation (TAVI) for aortic stenosis in older patients is the standard of care with a well-established supply density in Germany. In the near future, healthcare reform is planned that may affect TAVI capacities. Therefore, it is important to know how political regulations may interfere with access to services and what the need for TAVI will be in the future, based on demographic trends.MethodsThe number of TAVI procedures (DRG F98A +F98) and the in-hospital main diagnoses of aortic stenosis (ICD I35) in 2021 were analyzed at the level of county or federal state based on anonymized data from hospital reports, according to § 21 of the German hospital reimbursement law. The number of TAVI and aortic stenosis cases was projected for 2035 based on data from the German Federal Statistical Office on demographic developments. With quality assurance data from hospitals in 2019 and a route planner, the travel time to the next hospital performing TAVI (OPS 5‑35a.0) was calculated, and the consequence of a politically suggested minimum volume cut-off was analyzed.ResultsIn 2021, a total of 26,506 TAVI procedures were reported with a mean number of TAVI per 100,000 inhabitants of 32 (range between federal states from 25 to 42). Among the 66,045 diagnoses of aortic stenosis, there was a variation per 100,000 inhabitants from 64 to 108 (mean 79) between federal states. Compared to 2021, an additional 8748 (+13%) diagnoses of aortic stenosis and an increase of 4673 (+18%) TAVI procedures is to be expected in 2035. In 2019, 57% of German citizens could reach a TAVI hospital within 30 min and 91% within 60 min of driving time by car (mean time to hospital 31 min). Applying a minimum number of 150 TAVI/hospital per year would increase the driving time to hospital from 33 to 52 min in Saxony-Anhalt and instantly remove six out of eight hospitals from service in Hesse.ConclusionRegulation of TAVI services by minimum volume numbers would arbitrarily interfere with access to services, in contradiction to the medical service assurance tasks of federal state governments. These issues should be considered in the upcoming healthcare system reform.