Search

Background Limited data exist on strain changes after transcatheter aortic valve implantation (TAVI) in patients with aortic regurgitation (AR). Case summary Three patients with AR undergoing TAVI showed an initial reduction in global longitudinal strain (GLS), followed by sustained GLS improvement within the first year. Discussion Findings align with those of surgically treated patients with AR. There is a possible superiority of GLS to left ventricular end-diastolic diameter ratio in assessing patients with severe volume overload. [ABSTRACT FROM AUTHOR]

Aims Implantation of an implantable cardiac monitor (ICM) is a simple procedure, but adds significant and increasing workload to the arrhythmia service. In 2020, we established a nurse-led ICM implantation service. We aimed to analyse patient satisfaction, adverse events during implant, and ICM re-interventions with nurse-led ICM implantation (N-Implant) compared to physician-led ICM implantation (P-Implant). Methods and results From January 2020 to December 2021, we included all consecutive patients implanted with an ICM in a prospective registry. We collected data on patient characteristics, implant procedure, and follow-up. Patients were interviewed by phone four weeks after ICM implantation. Of 321 patients implanted with an ICM (median age 67 years; 33% women), 189 (59%) were N-Implants. More N-Implants were performed in the outpatient clinic compared to P-Implants (95% vs. 8%; P < 0.001). Two N-Implant patients experienced vaso-vagal reaction during implantation (1%), whereas no adverse events occurred during P-Implant (P = 0.51). A total of 297 patients (93%) completed the questionnaire. Duration of pain was shorter and wound closure after 2 weeks better following N-Implant (P = 0.019 and P = 0.018). A minor bruise or swelling at the implant site was reported more frequently after N-Implant (P = 0.003 and P = 0.041). Patient satisfaction was excellent with both N-Implant and P-Implant (99% and 97%; P = 0.16). After a median follow-up of 242 days (range 7–725 days), five ICMs (2%) were explanted prematurely, without differences among groups. Reasons for premature explants were local discomfort (n = 2), infection, MRI, and ICM malfunction. Conclusion Nurse-led ICM implantation has excellent patient satisfaction without compromising safety. N-Implant both expands nursing competencies and reduces physician workload. [ABSTRACT FROM AUTHOR]

Background and Aims The European Union Medical Device Regulation 2017/745 challenges key stakeholders to follow transparent and rigorous approaches to the clinical evaluation of medical devices. The purpose of this study is a systematic evaluation of published clinical evidence underlying selected high-risk cardiovascular medical devices before and after market access in the European Union (CE-marking) between 2000 and 2021. Methods Pre-specified strategies were applied to identify published studies of prospective design evaluating 71 high-risk cardiovascular devices in seven different classes (bioresorbable coronary scaffolds, left atrial appendage occlusion devices, transcatheter aortic valve implantation systems, transcatheter mitral valve repair/replacement systems, surgical aortic and mitral heart valves, leadless pacemakers, subcutaneous implantable cardioverter-defibrillator). The search time span covered 20 years (2000–21). Details of study design, patient population, intervention(s), and primary outcome(s) were summarized and assessed with respect to timing of the corresponding CE-mark approval. Results At least one prospective clinical trial was identified for 70% (50/71) of the pre-specified devices. Overall, 473 reports of 308 prospectively designed studies (enrolling 97 886 individuals) were deemed eligible, including 81% (251/308) prospective non-randomized clinical trials (66 186 individuals) and 19% (57/308) randomized clinical trials (31 700 individuals). Pre-registration of the study protocol was available in 49% (150/308) studies, and 16% (48/308) had a peer-reviewed publicly available protocol. Device-related adverse events were evaluated in 82% (253/308) of studies. An outcome adjudication process was reported in 39% (120/308) of the studies. Sample size was larger for randomized in comparison to non-randomized trials (median of 304 vs. 100 individuals, P <.001). No randomized clinical trial published before CE-mark approval for any of the devices was identified. Non-randomized clinical trials were predominantly published after the corresponding CE-mark approval of the device under evaluation (89%, 224/251). Sample sizes were smaller for studies published before (median of 31 individuals) than after (median of 135 individuals) CE-mark approval (P <.001). Clinical trials with larger sample sizes (>50 individuals) and those with longer recruitment periods were more likely to be published after CE-mark approval, and were more frequent during the period 2016–21. Conclusions The quantity and quality of publicly available data from prospective clinical investigations across selected categories of cardiovascular devices, before and after CE approval during the period 2000–21, were deemed insufficient. The majority of studies was non-randomized, with increased risk of bias, and performed in small populations without provision of power calculations, and none of the reviewed devices had randomized trial results published prior to CE-mark certification. [ABSTRACT FROM AUTHOR]

Introduction: Conventional transvenous pacemaker leads may interfere with the tricuspid valve leaflets, tendinous chords, and papillary muscles, resulting in significant tricuspid valve regurgitation (TR). Leadless pacemakers (LLPMs) theoretically cause less mechanical interference with the tricuspid valve apparatus. However, data on TR after LLPM implantation are sparse and conflicting. Our goal was to investigate the prevalence of significant TR before and after LLPM implantation. Methods: Patients who received a leadless LLPM (Micra™ TPS, Medtronic) between May 2016 and May 2021 at our center were included in this observational study if they had at least a pre‐ and postinterventional echocardiogram (TTE). The evolution of TR severity was assessed. Following a systematic literature review on TR evolution after implantation of a LLPM, data were pooled in a random‐effects meta‐analysis. Results: We included 69 patients (median age 78 years [interquartile range (IQR) 72–84 years], 26% women). Follow‐up duration between baseline and follow‐up TTE was 11.4 months (IQR 3.5–20.1 months). At follow‐up, overall TR severity was not different compared to baseline (p =.49). Six patients (9%) had new significant TR during follow‐up after LLPM implantation, whereas TR severity improved in seven patients (10%). In the systematic review, we identified seven additional articles that investigated the prevalence of significant TR after LLPM implantation. The meta‐analysis based on 297 patients failed to show a difference in significant TR before and after LLPM implantation (risk ratio 1.22, 95% confidence interval 0.97–1.53, p =.11). Conclusion: To date, there is no substantial evidence for a significant change in TR after implantation of a LLPM. [ABSTRACT FROM AUTHOR]

Copyright of Italica Wratislaviensia is the property of Wydawnictwo Adam Marszalek and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

A gifted professor constructs a combat machine at a secret military base. He equips a cyborg with human traits; personality, emotions and memories of his deceased wife. Numero Uno, known as "Laura", is the heroine of the precursory novel entitled Il Grande Ritratto published by Dino Buzzati in 1960. In this article, I try to extract her human and inhuman features and try to place this into a post or transhumanist concept. I consider the balance of these traits, taking into account the author"s relationship to the essence of humanity, of which he spoke about in interviews. [ABSTRACT FROM AUTHOR]