Novel, vessel anatomy adjusting drug-coated balloon-Preclinical evaluation in peripheral porcine arteries

The diameter of balloons or stents is selected according to the estimated reference vessel diameter and do not adapt to the vessel anatomy. The aim of the present preclinical studies was to investigate a novel, vessel anatomy adjusting hypercompliant drug-coated balloon catheter (HCDCB).Methods Hypercompliant balloon membranes were coated in a constricted state with high drug density. Drug adherence was investigated in vitro, transfer to the porcine peripheral arteries and longitudinal distribution in vivo. In young domestic swine, neointimal proliferation was induced by vessel overstretch and continuous irritation by permanent stents. Uncoated hypercompliant balloons (HCB), and standard uncoated balloons and drug‐coated balloons (DCB) served as controls. Efficacy was assessed by angiography, optical coherence tomography (OCT), and histomorphometry. Results HCDCB lost 18.0 ± 3.9% of dose during in vitro simulated delivery to the lesion. Drug transfer to the vessel wall was 13.9 ± 6.4% and drug concentration was 1,044 ± 529 ng/mg tissue. Four weeks after treatment, the histomorphometric neointimal area was smaller with HCDCB versus uncoated HCB (2.39 ± 0.55 mm2 vs. 3.26 ± 0.72 mm2, p = .038) and area stenosis (OCT) was less (11.6 ± 6.9% vs. 24.7 ± 9.7%, p = .022). No premature death occurred and no in‐life clinical symptoms or treatment‐associated thrombi were observed. Conclusions HCDCB were found to inhibit excessive neointimal proliferation. Balloon adaption to different vessel diameters and shapes may provide drug‐delivery in irregular lumen and facilitate balloon selection

Off-the-shelf barrier for emergency intubation in the cardiac catheterization laboratory during the coronavirus disease 2019 (COVID-19) pandemic

With the spread of SARS-CoV-2, it is expected that cases of acute coronary syndrome in the setting of coronavirus disease 2019 (COVID-19) develop. As expensive and sophisticated protection devices are not widely available, we have been working on a simple, off-the-shelf protection device for endotracheal intubation of potentially infected patients. For this purpose, we used a large transparent plastic bag (such as the sterile protective cover of the lead glass shield) for protection from airborne infections. The cover is moved over the patient's head from cranial to caudal, covering the catheter table including the torso with no need for patient mobilization. The intubation is done conventionally under direct visual control

Prediction of conduction disturbances in patients undergoing transcatheter aortic valve replacement

Aim Transcatheter aortic valve replacement (TAVR) can cause intraventricular conduction disturbances (ICA), particularly left bundle branch block (BBB) and high-degree atrioventricular block (HAVB). The aim of this study was to investigate clinical, anatomical, procedural, and electrophysiological parameters predicting ICA after TAVR. Methods Patients with severe aortic stenosis (n=203) without pacing devices undergoing TAVR with a self-expanding (n=103) or balloon-expanding (n=100) valve were enrolled. Clinical and anatomical parameters, such as length of the membranous septum (MS) and implantation depth, were assessed. His-ventricular interval (HVi) before and after implantation was determined. 12-lead-electrocardiograms (ECG) before, during and after 3 and 30 days after TAVR were analyzed for detection of any ICA. Results Among 203 consecutive patients (aortic valve area 0.78±0.18 cm2 , age 80±6 years, 54% male, left ventricular ejection fraction 52±10%), TAVR led to a signifcant prolongation of infranodal conduction in all patients from 49±10 ms to 59±16 ms (p=0.01). The HVi prolongation was independent of valve types, occurrence of HAVB or ICA. Fifteen patients (7%) developed HAVB requiring permanent pacemaker (PPM) implantation and 63 patients (31%) developed ICA within 30 days. Pre-existing BBB (OR 11.64; 95% CI 2.87–47.20; p=0.001), new-onset left BBB (OR 15.72; 95% CI 3.05–81.03; p=0.001), and diabetes mellitus (OR 3.88; 95% CI 1.30–15.99; p=0.02) independently predicted HAVB requiring PPM. Neither pre-existing right BBB, a prolonged postHVi, increases in PR duration, any of the TAVR implantation procedural and anatomic nor echocardiographic characteristics were predictive for later HAVB. Conclusions New-onset left BBB and diabetes mellitus independently predicted HAVB requiring PPM after TAVR and helped to identify patients at risk. Electrophysiologic study (EPS) of atrioventricular conduction was neither specifc nor predictive of HAVB and can be skipped. Trial registration number NCT04128384 (https://www.clinicaltrials.gov)

Decline of emergency admissions for cardiovascular and cerebrovascular events after the outbreak of COVID-19

Background The spread of the novel coronavirus SARS-CoV-2 and the guidance from authorities for social distancing and media reporting lead to significant uncertainty in Germany. Concerns have been expressed regarding the underdiagnosing of harmful diseases. We explored the rates of emergency presentations for acute coronary syndrome (ACS) and acute cerebrovascular events (ACVE) before and after spread of SARS-CoV-2. Methods We analyzed all-cause visits at a tertiary university emergency department and admissions for ACS and ACVE before (calendar weeks 1–9, 2020) and after (calendar weeks 10–16, 2020) the first coronavirus disease (COVID-19) case in the region of the Saarland, Germany. The data were compared with the same period of the previous year. Results In 2020 an average of 346 patients per week presented at the emergency department whereas in 2019 an average of 400 patients presented up to calendar week 16 (p = 0.018; whole year 2019 = 395 patients per week). After the first COVID-19 diagnosis in the region, emergency department visit volume decreased by 30% compared with the same period in 2019 (p = 0.0012). Admissions due to ACS decreased by 41% (p = 0.0023 for all; Δ − 71% (p = 0.007) for unstable angina, Δ − 25% (p = 0.42) for myocardial infarction with ST-elevation and Δ − 17% (p = 0.28) without ST-elevation) compared with the same period in 2019 and decreased from 142 patients in calendar weeks 1–9 to 62 patients in calendar weeks 10–16. ACVE decreased numerically by 20% [p = 0.25 for all; transient ischemic attack: Δ − 32% (p = 0.18), ischemic stroke: Δ − 23% (p = 0.48), intracerebral haemorrhage: Δ + 57% (p = 0.4)]. There was no significant change in ACVE per week (p = 0.7) comparing calendar weeks 1–9 (213 patients) and weeks 10–16 (147 patients). Testing of 3756 samples was performed to detect 58 SARS-CoV-2 positive patients (prevalence 1,54%, thereof one patient with myocardial and two with cerebral ischemia) up to calendar week 16 in 2020. Conclusions The COVID-19 pandemic was associated with a significant decrease in all-cause admission and admissions due to cardiovascular events in the emergency department. Regarding acute cerebrovascular events there was a numerical decrease but no significant difference

Short-term antigen presentation and single clonal burst limit the magnitude of the CD8(+) T cell responses to malaria liver stages.

Malaria sporozoites induce swift activation of antigen-specific CD8(+) T cells that inhibit the intracellular development of liver-stage parasites. The length of time of functional in vivo antigen presentation, estimated by monitoring the activation of antigen-specific CD8(+) T cells, is of short duration, with maximum T cell activation occurring within the first 8 h after immunization and lasting approximately 48 h. Although the magnitude of the CD8(+) T cell response closely correlates with the number of parasites used for immunization, increasing the time of antigen presentation by daily immunizations does not enhance the magnitude of this response. Thus, once a primary clonal burst is established, the CD8(+) T cell response becomes refractory or unresponsive to further antigenic stimulation. These findings strongly suggest that the most efficient strategy for the induction of primary CD8(+) T cell responses is the delivery of a maximal amount of antigen in a single dose, thereby ensuring a clonal burst that involves the largest number of precursors to become memory cells

One-year clinical outcomes in patients with renal insufficiency after contemporary PCI: data from a multicenter registry

Chronic kidney disease (CKD) is highly prevalent in patients with coronary artery disease (CAD).Methods e-Ultimaster is a prospective, single-arm, multi-center registry with clinical follow-up at 3 months and 1 year.Objective The outcome following revascularization using contemporary technologies (new-generation abluminal sirolimus-eluting stents with thin struts) in patients with CKD (i.e., glomerular filtration rate of < 60 mL/min/1.73m2) and in patients with hemodialysis (HD) is unknown.Results A total of 19,475 patients were enrolled, including 1466 patients with CKD, with 167 undergoing HD. Patients with CKD had a higher prevalence of overall comorbidities, multiple/small vessel disease (≤ 2.75 mm), bifurcation lesions, and more often left main artery treatments (all p < 0.0001) when compared with patients with normal renal function (reference). CKD patients had a higher risk of target lesion failure (unadjusted OR, 2.51 [95% CI 2.04–3.08]), target vessel failure (OR, 2.44 [95% CI 2.01–2.96]), patient-oriented composite end point (OR, 2.19 [95% CI 1.87–2.56]), and major adverse cardiovascular events (OR, 2.34 [95% CI 1.93–2.83, p for all < 0.0001]) as reference. The rates of target lesion revascularization (OR, 1.17 [95% CI 0.79–1.73], p = 0.44) were not different. Bleeding complications were more frequently observed in CKD than in the reference (all p < 0.0001).Conclusion In this worldwide registry, CKD patients presented with more comorbidities and more complex lesions when compared with the reference population. They experienced higher rate of adverse events at 1-year follow-up

Correction to: One‑year clinical outcomes in patients with renal insuffciency after contemporary PCI: data from a multicenter registry

The original version of this article unfortunately contained a mistake. The given name and family name of the fourth author Saaraaken Kulenthiran were switched in the original publication

Mechanical thrombectomy in intermediate- and high-risk acute pulmonary embolism: hemodynamic outcomes at three months

Background Mechanical thrombectomy has been shown to reduce thrombus burden and pulmonary artery pressure (PAP) and to improve right ventricular (RV) function in patients with high-risk or intermediate-high-risk pulmonary embolism (PE). As hemodynamic data after mechanical thrombectomy for PE are scarce, we aimed to assess the hemodynamic effects of mechanical thrombectomy in acute PE with right heart overload. Methods In this prospective, open-label study, patients with acute symptomatic, computed tomographydocumented PE with signs of right heart overload underwent mechanical thrombectomy using the FlowTriever System. Right heart catheterization was performed immediately before and after thrombectomy and after three months. Transthoracic echocardiography was performed before thrombectomy, discharge, and at three months. This analysis was done after 20 patients completed three months of follow-up. Results Twenty-nine patients (34% female) underwent mechanical thrombectomy, of which 20 completed three months follow-up with right heart catheterization. Most patients were at high (17%) or intermediate-high (76%) risk and had bilateral PE (79%). Before thrombectomy, systolic PAP (sPAP) was severely elevated (mean 51.3±11.6 mmHg). Mean sPAP dropped by -15.0 mmHg (95% confidence interval [CI]: -18.9 to -11.0; p<0.001) immediately after the procedure and continued to decrease from post-thrombectomy to three months (-6.4 mmHg, 95% CI: -10-0 to -2.9; p=0.002). RV/left ventricular (LV) ratio immediately reduced within two days by -0.37 (95% CI: -0.47 to -0.27; p<0.001). The proportion of patients with a tricuspid annular plane systolic excursion (TAPSE)/sPAP ratio<0.31 mm/mmHg decreased from 28% at baseline to 0% before discharge and at three months (p=0.007). There were no procedurerelated major adverse events. Conclusions Mechanical thrombectomy for acute PE was safe and immediately reduced PAP and improved right heart function. The reduction in PAP was maintained at three months follow-up

Thrombus Aspiration in ThrOmbus containing culpRiT lesions in Non-ST-Elevation Myocardial Infarction (TATORT-NSTEMI): study protocol for a randomized controlled trial

Current guidelines recommend thrombus aspiration in patients with ST-elevation myocardial infarction (STEMI); however, there are insufficient data to unequivocally support thrombectomy in patients with non-STEMI (NSTEMI).Methods/Design The TATORT-NSTEMI (Thrombus Aspiration in ThrOmbus containing culpRiT lesions in Non-ST-Elevation Myocardial Infarction) trial is a prospective, controlled, multicenter, randomized, open-label trial enrolling 460 patients. The hypothesis is that, against a background of early revascularization, adjunctive thrombectomy leads to less microvascular obstruction (MO) compared with conventional percutaneous coronary intervention (PCI) alone, as assessed by cardiac magnetic resonance imaging (CMR) in patients with NSTEMI. Patients will be randomized in a 1:1 fashion to one of the two treatment arms. The primary endpoint is the extent of late MO assessed by CMR. Secondary endpoints include early MO, infarct size, and myocardial salvage assessed by CMR as well as enzymatic infarct size and angiographic parameters, such as thrombolysis in myocardial infarction flow post-PCI and myocardial blush grade. Furthermore, clinical endpoints including death, myocardial re-infarction, target vessel revascularization, and new congestive heart failure will be recorded at 6 and 12 months. Safety will be assessed by the incidence of bleeding and stroke.Summary The TATORT-NSTEMI trial has been designed to test the hypothesis that thrombectomy will improve myocardial perfusion in patients with NSTEMI and relevant thrombus burden in the culprit vessel reperfused by early PCI