A novel integrated care concept (NICC) versus standard care in the treatment of chronic cardiovascular diseases: protocol for the randomized controlled trial CardioCare MV.

BACKGROUND: Cardiovascular diseases are the major cause of death globally and represent a major economic burden on health care systems. Positive effects of disease management programs have been shown for patients with heart failure (HF). Remote monitoring and telemonitoring with active intervention are beneficial in atrial fibrillation (AF) and therapy-resistant hypertension (TRH), respectively. For these patients, we have developed a novel integrated care concept (NICC) which combines telemedicine with intensive support by a care center, including a call center, an integrated care network including inpatient and outpatient care providers and guideline therapy for patients. METHODS: The aim of the study is to demonstrate the superiority of NICC over guideline therapy alone. The trial is designed as open-label, bi-center, parallel-group design with two groups and a blinded observer. Patients will be included if they are either inpatients or if they are referred to the outpatient clinic of the hospitals by their treating physician. Randomization will be done individually with stratification by cardiovascular disease (AF, HF, TRH), center and admission type. Primary endpoints are based on the 1-year observation period after randomization. The first primary endpoint is the composite endpoint consisting of mortality, stroke and myocardial infarction. The number of hospitalizations form the second primary endpoint. The third primary endpoint is identical to the first primary endpoint plus cardiac decompensation. Adjustments for multiple testing are done using a fall-back strategy. Secondary endpoints include patient adherence, health care costs, quality of life, and safety. A sample size of 2930 gives 80% power at the two-sided 2.5% test level for the first primary endpoint. The power for the second primary endpoint is 99.8% at this sample size, and it is 80% with 1086 patients. DISCUSSION: This study will inform care providers whether quality of care can be improved by an integrated care concept providing telemedicine through a round-the-clock call center approach. We expect that cost of the NICC will be lower than standard care because of reduced hospitalizations. If the study has a positive result, NICC is planned to be immediately rolled out in the federal state of Mecklenburg-West Pomerania and other federal states in Germany. The trial will also guide additional research to disentangle the effects of this complex intervention. TRIAL REGISTRATION: DRKS, ID: DRKS00013124 . Registered on 5 October 2017; ClinicalTrials.gov , ID: NCT03317951. Registered on 17 October 2017.

Apical and midventricular transient left ventricular dysfunction syndrome (tako-tsubo cardiomyopathy): frequency, mechanisms, and prognosis.

BACKGROUND: The frequency and potential differences between patients with apical ("typical") and midventricular ("atypical") ballooning have not been described. METHODS: Consecutive patients with the diagnosis of a troponin-positive acute coronary syndrome (ACS) were prospectively included into a registry (n = 3,265). Of those, 2,944 patients underwent left-heart catheterization and form the study population. Demographic, clinical, and angiographic data including assessment of microvascular dysfunction (Thrombolysis in Myocardial Infarction [TIMI] blush grade, corrected TIMI frame count), as well as clinical outcome were assessed in all patients. RESULTS: In patients with troponin-positive ACS, the frequency of transient cardiomyopathy was 1.2% (35 of 2,944 patients). Typical apical wall motion abnormality was observed in 21 of 35 patients (60%), as compared to an atypical (midventricular) pattern in 14 of 35 patients (40%). Both groups did not differ regarding demographic, clinical, laboratory, or angiographic parameters. Scintigraphy and PET studies were performed in 17 of 35 patients (49%) with transient cardiomyopathy, and showed a strong correlation between location of wall motion abnormality and myocardial metabolism defects, with a significantly higher apical decrease in glucose uptake in patients with a typical pattern. CONCLUSIONS: Transient cardiomyopathy affects approximately 1% of patients with a troponin-positive ACS. A typical apical wall motion abnormality is seen in only 60% of patients. Transient cardiomyopathy, also termed Tako-Tsubo cardiomyopathy, therefore should no longer be regarded as an exclusively apical ballooning syndrome, but rather a transient left ventricular dysfunction syndrome with an apical or midventricular pattern of wall motion abnormality.

Comparison of coronary restenosis rates in matched patients with versus without diabetes mellitus.

Diabetes mellitus (DM) is an established risk factor for stent restenosis, in part as a result of the smaller vessel dimensions and longer lesions. This study compared the magnitude of acute lumen gain and late lumen loss after elective coronary stent implantation in patients with and without DM using a matched-pair analysis. A total of 133 patients with DM and 192 coronary lesions were included in this analysis. A group of 192 lesions in 182 patients without DM were matched in a pairwise fashion, stratifying for reference diameter, minimal luminal diameter, and lesion length. The binary restenosis rate at the 5-month follow-up angiography was 25% in the DM group and 14% in the non-DM group (p <0.01). Acute angiographic lumen gain (1.47 +/- 0.41 vs 1.56 +/- 0.38 mm, p = 0.03) and late lumen loss (0.64 +/- 0.42 vs 0.55 +/- 0.36 mm, p = 0.02) were significantly different between the DM and non-DM groups. In conclusion, suboptimal acute procedural results and an exaggerated neointimal proliferation contributed by about 50% to the lower net lumen gain in the DM group. Patients with DM had a significantly higher restenosis rate even when matched for preprocedural angiographic lesion dimensions. Mechanistically, inferior procedural results, as well as exaggerated neointimal proliferation, are, quantitatively, equally important in this process.

Thienopyridines in percutaneous coronary interventions: standard procedures and high risk subsets.

Due to the significant clinical and economic consequences of subacute stent thrombosis and the use of more complex devices (brachytherapy, drug eluting stents) in a variety of clinical situations (i.e. acute coronary syndromes), initiation and duration of a combined antiplatelet therapy using aspirin and a thienopyridine drug has become an issue of ongoing discussion in interventional cardiology. This review will provide a short introduction into the pathophysiology of stent thrombosis before standard procedures and critical issues on the use of thienopyridines in the setting of coronary interventions are discussed. Furthermore, clinically relevant issues that are not clearly covered by recommendations or guidelines like thienopyridines after coronary interventions in patients on chronic oral anticoagulation are also addressed.

Treatment of in-stent restenosis using a paclitaxel-eluting stent: acute results and long-term follow-up of a matched-pair comparison with intracoronary beta-radiation therapy.

AIMS: Intracoronary radiation therapy (ICR) has significantly improved the long-term outcome after treatment of diffuse in-stent restenosis (ISR). The efficacy of drug eluting stents in this setting remains less well defined. This matched-pair analysis compared the procedural and long-term clinical and angiographic outcome after treatment of diffuse ISR using a paclitaxel-eluting stent (PES) with intracoronary beta-radiation therapy. METHODS AND RESULTS: Twenty-two patients receiving 25 PES (ACHIEVE, Cook, 3.1 microg paclitaxel per square millimeter, non-polymer based coating) for ISR underwent 6-month angiographic and 12-month clinical follow-up. From a database including 141 patients (174 lesions) undergoing intracoronary beta-radiation for ISR, 25 lesions (25 patients) were pair-matched with the former group for lesion length and vessel size. PES implantation and ICR were successful in all patients with a significantly lower postprocedural in-stent diameter stenosis in the PES group (8+/-12% vs. 18+/-8%, p < 0.01). Angiographic binary in-lesion restenosis at 6 month was 20% (5/25 lesions) in the PES group and 16% (4/25) in the ICR group (p = 1.0). PES implantation resulted in significantly higher in-stent MLD at FU (2.10+/-0.71 vs. 1.75+/-0.36, p = 0.03) and a higher in-stent net gain (PES: 1.19+/-0.69, ICR: 0.84+/-0.49, p = 0.04). Two patients in the PES group and 6 patients in the ICR group experienced a target lesion revascularisation at 12-month follow-up (p = 0.25). CONCLUSION: Implantation of a non-polymer based paclitaxel-elution stent and conventional ICR therapy for complex ISR lead to comparable acute and long-term clinical and angiographic follow-up results.

Relation of fasting insulin plasma levels to restenosis after elective coronary stent implantation in patients without diabetes mellitus.

The results of this study in 172 patients without diabetes who underwent elective stent implantation showed a significant correlation between preprocedural fasting insulin serum levels and angiographic late lumen loss (correlation coefficient 0.49, p <0.0001). Furthermore, the waist-to-hip ratio and C-peptide and hemoglobin A1c serum levels were associated with the occurrence of binary angiographic restenosis.

Dexamethasone and restenosis after coronary stent implantation: new indication for an old drug?

Restenosis after stent implantation is mainly characterized by an inflammatory response to the procedural injury and an intense fibrocellular response including smooth muscle cell (SMC) proliferation. After angioplasty alone, the restenosis process also involves thrombus formation and negative remodeling. Due to the pleiotropic mode of action exerted by glucocorticoids which include profound anti-inflammatory and immunosuppressive effects, direct inhibition on SMC proliferation and apoptosis, their potential in the prevention of restenosis has gained widespread interest. Over the last decade, preclinical and clinical data have not been able to conclusively document a robust therapeutic effect on restenosis after angioplasty or stent implantation. Only recently, preclinical data and limited observations in humans using drug eluting stents for local drug delivery have suggested beneficial effects of dexamethasone on neointimal proliferation. Randomized clinical trials using local drug delivery are expected to start in the near future. In the light of these ongoing developments, this review summarizes the pathophysiological basis of glucocorticoid action in the context of restenosis, provides an overview of the animal data available and discusses the clinical results that have been gathered over the last decade with particular emphasis on dexamethasone.