Aims Mitral valve transcatheter edge-to-edge repair (TEER) has been established as a suitable alternative to mitral valve surgery in patients with severe mitral regurgitation (MR) and high surgical risk. The PASCAL system represents a novel device, potentially augmenting the toolkit for TEER. The aim of this study was to assess and compare short and 1 year safety and efficacy of the PASCAL and MitraClip systems for TEER. Methods and results Procedural, short, and 1 year outcomes of a 1:2 propensity-matched cohort including 41 PASCAL and 82 MitraClip cases were investigated. Matching was based on clinical, laboratory, echocardiographic, and functional characteristics. The primary endpoints assessed were procedural success [as defined by the Mitral Valve Academy Research Consortium (MVARC)], residual MR, functional class, and a composite endpoint comprising death, heart failure hospitalization, and mitral valve re-intervention. We found for the PASCAL and the matched MitraClip cohort no significant differences in MVARC defined technical (90.2% vs. 95.1%, P = 0.44), device (90.2% vs. 89.0%, P = 1.0), or procedural (87.8% vs. 80.5%, P = 0.45) success rates. Accordingly, the overall MR reduction and improvement in New York Heart Association (NYHA) class were comparable (1 year follow-up: MR ≤ 2 95% vs. 93.6%, P = 1.0; NYHA ≤ 2 57.1% vs. 66.7%, P = 0.59). The composite outcome revealed no statistically significant difference between both devices (1 year follow-up: 31.7% vs. 37.8%, P = 0.55). Interestingly, we found at both short and 1 year follow-up a significantly higher rate of patients with none or trace MR in the PASCAL-treated cohort (short follow-up: 17.9% vs. 0%, P = 0.0081; 1 year follow-up: 25% vs. 0%, P = 0.0016). Conversely, the rate of aborted device implantations due to an elevated transmitral gradient was higher in PASCAL interventions (9.8% vs. 1.2%, P = 0.04). Conclusions Transcatheter edge-to-edge repair using the PASCAL or MitraClip device results in favourable and comparable outcomes regarding safety, efficacy, and clinical improvement after 1 year.

Background: Percutaneous tricuspid valve leaflet repair is an emerging treatment option for severe tricuspid regurgitation (TR). Recent studies demonstrated the usefulness and feasibility of the lately introduced TriClip and PASCAL Transcatheter Valve Repair System. However, initial experiences regarding safety and efficacy of the novel transcatheter PASCAL Ace implant system have not yet been reported. Methods: Sixteen patients with severe, massive, or torrential TR underwent tricuspid leaflet repair using the PASCAL Ace implant at our cardiology department. All patients suffered from symptomatic right-sided heart failure with New York Heart Association functional class III or IV. Clinical, laboratory, echocardiographic, and procedural data were assessed. The primary efficiency end point was postprocedural reduction in TR of at least 1 grade. Secondary end points were feasibility, safety, clinical outcome, and improvement of structural and functional right heart parameters obtained by echocardiography. Results: Eleven procedures (69%) resulted in successful reduction of TR. In 4 patients, PASCAL Ace implantation was not successful and one patient did not achieve TR reduction despite PASCAL Ace implantation. One major bleeding related to the intervention occurred. Eight patients (73%) with successful TR reduction reported a significant improvement of New York Heart Association functional class 4 weeks after implantation ( P =0.008). A significant reduction in right atrial volume from 84±41 mL/m ² to 69±36 mL/m ² ( P =0.004) and right ventricular end-diastolic diameter from 50±7 mm to 47±8 mm ( P =0.013) was observed; however, we did not see an improvement in right ventricular function directly after implantation. Conclusions: Tricuspid valve leaflet repair using the transcatheter PASCAL Ace implant system has the potential to improve clinical status and right heart reverse remodeling in patients with severe TR.

We present CARDIO:DE, the first freely available and distributable large German clinical corpus from the cardiovascular domain. CARDIO:DE encompasses 500 clinical routine German doctor’s letters from Heidelberg University Hospital, which were manually annotated. Our prospective study design complies well with current data protection regulations and allows us to keep the original structure of clinical documents consistent. In order to ease access to our corpus, we manually de-identified all letters. To enable various information extraction tasks the temporal information in the documents was preserved. We added two high-quality manual annotation layers to CARDIO:DE, (1) medication information and (2) CDA-compliant section classes. To the best of our knowledge, CARDIO:DE is the first freely available and distributable German clinical corpus in the cardiovascular domain. In summary, our corpus offers unique opportunities for collaborative and reproducible research on natural language processing models for German clinical texts.

Aims Mitral valve regurgitation (MR) is common in patients with advanced heart failure (HF). Percutaneous mitral valve repair (PMVR) via MitraClip (MC) has emerged as a feasible treatment strategy for these high‐risk patients. However, as HF often further progresses, there is a frequent need for left ventricular assist device (LVAD) implantation in these patients. We aimed to investigate whether prior MC implantation affects the subsequent LVAD implantation and outcome. Methods and results Thirty‐seven patients with advanced HF and significant MR who underwent LVAD implantation were retrospectively analysed. Follow‐up data were collected at 1 year after LVAD implantation. Primary endpoint was all‐cause mortality. Secondary endpoint included peri‐operative parameters and clinical development depicted as New York Heart Association (NYHA) class and Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) level. Seventeen patients initially received a MC device (MC group), resulting in a significant reduction in MR grade. After MC, NYHA class and INTERMACS level further worsened, leading to subsequent LVAD implantation after a median time of 475 days in the MC group. At LVAD implantation, overall characteristics were comparable with those of the patients undergoing LVAD implantation without prior MC placement (no‐MC group). Procedural data revealed a higher incidence of right ventricular (RV) failure needing mechanical RV assistance and a longer need for nitric oxide ventilation in the MC group after LVAD implantation. One‐year survival was slightly better in the no‐MC group compared with the MC group [41% (n = 7/17) vs. 65% (n = 13/20); P = 0.15], albeit event‐free survival was comparable between both groups, MC and no‐MC. Conclusions LVAD implantation after MC is feasible and safe. However, in patients with advanced HF and severe MR, PMVR may only delay a needed LVAD implantation and thereby lead to poorer peri‐operative RV function and impaired outcome. Arguably, these patients might benefit from the timely management of advanced HF by the means of early LVAD implantation or heart transplantation.