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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]

Background: Transoesophageal echocardiography (TOE) provides accurate evaluation of mitral valve (MV) function following mitral transcatheter edge-to-edge repair (M-TEER) and may better detect complications in case of suboptimal result., Aims: We aimed to evaluate midterm anatomical changes and structural complications after M-TEER using TOE and investigate their association with clinical outcomes at 2 years., Methods: A follow-up TOE at 6 months was systematically recommended to all patients included in our institutional prospective M-TEER registry until December 2021. We assessed changes in the incidence of mitral regurgitation (MR), MV stenosis (≥5 mmHg), and partial or complete single leaflet device attachment (SLDA) between the index procedure and follow-up and evaluated MV area and annular dimensions in a subset of patients with available three-dimensional (3D) datasets. The clinical endpoint was a composite of mortality and heart failure (HF) rehospitalisation at 2 years., Results: Among the 373 patients included in the registry between February 2012 and December 2021, 128 patients (34%) underwent elective TOE at 6 months. Using TOE, severe MR was observed in 13.3% (n=17) of the patients. The number of patients with an elevated MV gradient increased from 17 (13.3%) after the procedure to 23 (18%) at 6 months, and a new partial or complete SLDA was detected in 7.8% (n=10). Based on 3D TOE measurements, significant increases in MV area, annular area, annular perimeter, and intercommissural (but not anteroposterior) diameter were observed compared to intraprocedural images. A mean MV gradient ≥5 mmHg (hazard ratio [HR] 2.30, 95% confidence interval [CI]: 1.10-4.81; p=0.023) and the presence of severe MR at 6 months (HR 3.26, 95% CI: 1.18-8.99; p=0.023) were associated with the primary endpoint, which was met in 34 (26.6%) patients at 2 years., Conclusions: TOE follow-up allowed the detection of complications that would not be diagnosed using transthoracic echocardiography only and should therefore be used liberally in the patients presenting with a suboptimal result. A mean MV gradient ≥5 mmHg and severe MR, diagnosed at the 6-month TOE follow-up, were associated with adverse clinical outcomes.