Background Percutaneous coronary interventions (PCI) with drug-coated balloons (DCB) might be a promising trade-off between balloon angioplasty and drug-eluting stents, since DCB inhibit neointimal proliferation and limit duration of dual antiplatelet therapy. We investigated the safety, feasibility, and 6-month results of fractional flow reserve (FFR)-guided use of the paclitaxel-coated SeQuent Please^® balloon without stenting for elective PCI of de novo lesions. Methods and results In 46 patients (54 lesions) with stable symptomatic coronary artery disease (CAD), a FFR-guided POBA (plain old balloon angioplasty) was performed. In case of a sufficient POBA result with residual stenosis < 40 %, FFR > 0.8 and no severe dissection, the target lesion was finally dilated using the DCB. Quantitative coronary angiography (QCA) was performed before and after the index procedure and at 6-month follow-up (f/u) to calculate late lumen loss (LLL) and net luminal gain (NLG). Optical coherence tomography (OCT) was performed at f/u to assess vascular remodeling. DCB-only treatment was applied to 43 patients (51 lesions), while 3 patients (3 lesions) needed provisional stenting. Invasive f/u was completed in 39 patients (47 lesions). At the stenotic site, the lumen diameter showed a trend toward progressive increase at f/u (LLL: −0.13 ± 0.44 mm, n.s.; NLG: 1.10 ± 0.53 mm, p < 0.001) without aneurysm formation or restenosis after DCB-only treatment. Conclusions FFR-guided DCB-only PCI of de novo lesions appeared feasible and safe in stable CAD with clopidogrel discontinuation after 4 weeks, showing a trend toward positive vessel remodeling without lumen loss at 6 months. Clinical trial registration http://www.clinicaltrials.gov. Unique identifier: NCT02120859

Background—: In this randomized trial, strut coverage and neointimal proliferation of a therapy of bare metal stents (BMSs) postdilated with the paclitaxel drug-eluting balloon (DEB) was compared with everolimus drug-eluting stents (DESs) at 6-month follow-up using optical coherence tomography. We hypothesized sufficient stent coverage at follow-up. Methods and Results—: A total of 105 lesions in 90 patients were treated with either XIENCE V DES (n=51) or BMS postdilated with the SeQuent Please DEB (n=54). At follow-up, comparable results on the primary optical coherence tomography end point (percentage uncovered struts 5.64±9.65% in BMS+DEB versus 4.93±9.29% in DES; P =0.366) were found. Thus, BMS+DEB achieved the prespecified noninferiority margin of 5% uncovered struts versus DES (difference between treatment means, 0.71%; one-sided upper 95% confidence interval, 4.14%; noninferiority P =0.04). Optical coherence tomography analysis showed significantly more global neointimal proliferation in the BMS+DEB group (15.7±7.8 versus 11.0±5.2 mm ³ proliferation volume/cm stent length; P =0.002). No significant focal in-stent stenosis analyzed with angiography (percentage diameter stenosis at follow-up, 22.8±11.9 versus 16.9±10.4; P =0.014) and optical coherence tomography (peak local area stenosis, 39.5±13.8% versus 36.8±15.6%; P =0.409) was found. Conclusions—: Good stent strut coverage of >94% was found in both therapy groups. Despite greater suppression of global neointimal growth in DES, both DES and BMS+DEB effectively prevented clinically relevant focal restenosis at 6-month follow-up. Clinical Trial Registration—: URL: http://www.clinicaltrials.gov . Unique identifier: NCT01056744.

Background: Hemolysis, a common adverse event associated with veno-arterial extracorporeal membrane oxygenation (VA-ECMO), may affect neuron-specific enolase (NSE) levels and potentially confound its prognostic value in predicting neurological outcomes in resuscitated patients without return of spontaneous circulation (ROSC) that require extracorporeal cardiopulmonary resuscitation (eCPR). Therefore, a better understanding of the relationship between hemolysis and NSE levels could help to improve the accuracy of NSE as a prognostic marker in this patient population. Methods: We retrospectively analyzed the records of patients who received a VA-ECMO for eCPR between 2004 and 2021 and were treated in the medical intensive care unit (ICU) of the University Hospital Jena. The outcome was measured clinically by using the Cerebral Performance Category Scale (CPC) four weeks after eCPR. The serum concentration of NSE (baseline until 96 h) was analyzed by enzyme-linked immunosorbent assay (ELISA). To evaluate the ability of individual NSE measurements to discriminate, receiver operating characteristic (ROC) curves were calculated. Serum-free hemoglobin (fHb, baseline until 96 h) served as a marker for identifying a confounding effect of parallel hemolysis. Results: 190 patients were included in our study. A total of 86.8% died within 4 weeks after ICU admission or remained unconscious (CPC 3–5), and 13.2% survived with a residual mild to moderate neurological deficit (CPC 1–2). Starting 24h after CPR, NSE was significantly lower and continued to decrease in patients with CPC 1–2 compared to the group with an unfavorable outcome of CPC 3–5. In addition, when evaluating on the basis of receiver operating characteristic curves (ROC), relevant and stable area under the curve (AUC) values for NSE could be calculated (48 h: 0.85 // 72 h: 0.84 // 96 h: 0.80; p < 0.01), and on the basis of a binary logistic regression model, relevant odds ratios for the NSE values were found even after adjusting for fHb regarding the prediction of an unfavorable outcome of CPC 3–5. The respective adjusted AUCs of the combined predictive probabilities were significant (48 h: 0.79 // 72 h: 0.76 // 96 h: 0.72; p ≤ 0.05). Conclusions: Our study confirms NSE as a reliable prognostic marker for poor neurological outcomes in resuscitated patients receiving VA-ECMO therapy. Furthermore, our results demonstrate that potential hemolysis during VA-ECMO does not significantly impact NSE’s prognostic value. These findings are crucial for clinical decision making and prognostic assessment in this patient population.

Background: Percutaneous tricuspid repair using the edge-to-edge technique is a novel treatment option. More data are needed to better understand which aspects predict a favorable outcome Methods: Twenty high-risk patients (78.6 ± 8.3 years, EUROScore II 9.1 ± 7.7%, STS score 8.8 ± 4.3) with severe symptomatic tricuspid regurgitation (TR) were treated with the MitraClip^® system. All patients underwent standardized pre-, peri-, and post-procedural evaluation. Acute success was defined as successful edge-to-edge repair with TR reduction of ≥ 1 grade and survival until hospital discharge. Results: Fifteen (75%) patients showed acute success until discharge and 12 (60%) at 30-day follow-up. In 5 (25%) patients repair failed due to either unsuccessful clip implantation (n = 2), single leaflet device attachment (n = 1), TR reduction < 1 grade (n = 1), or in-hospital death (n = 1). Comparing patients with successful procedure versus those with failed repair revealed similar comorbidities but more severe right heart failure, lower left ventricular ejection fraction, worse renal function, and higher diuretic equivalent doses in the failed repair group. No differences in conventional echocardiographic parameters for TR severity but more dilated tricuspid annulus geometry (tricuspid valve [TV] annulus, coaptation depth, tenting area) in the failed repair group were observed. The success rate of non-central/non-anteroseptal jet location was only 25%. Conclusions: Tricuspid annulus geometry assessment may be of crucial importance and seems to impact procedural outcomes in patients undergoing edge-to-edge TV repair. Further investigations including advanced imaging are needed to better understand and treat this complex valve disease. Background: Percutaneous tricuspid repair using the edge-to-edge technique is a novel treatment option. More data are needed to better understand which aspects predict a favorable outcome Methods: Twenty high-risk patients (78.6 ± 8.3 years, EUROScore II 9.1 ± 7.7%, STS score 8.8 ± 4.3) with severe symptomatic tricuspid regurgitation (TR) were treated with the MitraClip^® system. All patients underwent standardized pre-, peri-, and post-procedural evaluation. Acute success was defined as successful edge-to-edge repair with TR reduction of ≥ 1 grade and survival until hospital discharge. Results: Fifteen (75%) patients showed acute success until discharge and 12 (60%) at 30-day follow-up. In 5 (25%) patients repair failed due to either unsuccessful clip implantation (n = 2), single leaflet device attachment (n = 1), TR reduction < 1 grade (n = 1), or in-hospital death (n = 1). Comparing patients with successful procedure versus those with failed repair revealed similar comorbidities but more severe right heart failure, lower left ventricular ejection fraction, worse renal function, and higher diuretic equivalent doses in the failed repair group. No differences in conventional echocardiographic parameters for TR severity but more dilated tricuspid annulus geometry (tricuspid valve [TV] annulus, coaptation depth, tenting area) in the failed repair group were observed. The success rate of non-central/non-anteroseptal jet location was only 25%. Conclusions: Tricuspid annulus geometry assessment may be of crucial importance and seems to impact procedural outcomes in patients undergoing edge-to-edge TV repair. Further investigations including advanced imaging are needed to better understand and treat this complex valve disease.

Endothelial progenitor cells (EPC) are involved in neovascularization and endothelial integrity. They might be protective in atherosclerosis. Optical coherence tomography (OCT) is a precise intracoronary imaging modality that allows assessment of subintimal plaque development. We evaluated the influence of EPC on coronary plaque burden in stable disease and implemented a novel computational plaque analysis algorithm using OCT. Forty-three patients (69.8% males, 69.6 ± 7.7 years) were investigated by OCT during re-angiography 6 months after elective stent implantation. Different subpopulations of EPCs were identified by flow cytometry according to their co-expression of antigens (CD34+, CD133+, kinase domain receptor, KDR+). An algorithm was applied to calculate the underlying total plaque burden of the stented segments from OCT images. Plaque morphology was assessed according to international consensus in OCT imaging. A cumulative sub-strut plaque volume of 10.87 ± 12.7 mm3 and a sub-stent plaque area of 16.23 ± 17.0 mm2 were found within the stented vessel segments with no significant differences between different stent types. All EPC subpopulations (mean of EPC levels: CD34+/CD133+: 2.66 ± 2.0%; CD34+/KDR+: 7.50 ± 5.0%; CD34+/CD133+/KDR+: 1.12 ± 1.0%) inversely correlated with the identified underlying total plaque volume and plaque area (p ≤ 0.012). This novel analysis algorithm allows for the first time comprehensive quantification of coronary plaque burden by OCT and illustration as spread out vessel charts. Increased EPC levels are associated with less sub-stent coronary plaque burden which adds to previous findings of their protective role in atherosclerosis.