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Objective: This study evaluated the ergonomics and time requirements of using a novel automated suturing and titanium fastener deployment technology for chordal replacement in human heart specimens in open and minimally invasive cardiac surgery (MICS) simulators. Methods: Five cardiac surgeons used novel, manually powered expanded polytetrafluoroethylene (ePTFE) suturing devices to automate suture placement between mitral leaflets and papillary muscles in explanted cadaver hearts, along with customized titanium fastener delivery devices to secure suture and trim suture tails. This mitral chordal replacement test was conducted using surgical models simulating open and MICS mitral repair access. The study was approved by the institutional ethical board. Results: After a brief introduction to this technique using plastic models, study surgeons performed 48 chordal replacements in human mitral valves, placing 18 in an open model and 30 in a right minithoracotomy model. The time range to complete a single chordal replacement was between 55 s and 8 min, with an overall mean duration of 3.6 ± 1.5 min. No difference in duration of implantation was recorded for the MICS and open sternotomy simulators used. Good control of suture delivery was reported in 95.8% ( n = 46) of leaflet aspect of the sutures and in 100% ( N = 48) of papillary muscle sutures. Conclusions: Automated mitral chordal ePTFE suturing simulated through open and MICS access demonstrated quality handling and accurate placement of sutures in human heart specimens. A clinical trial using this technology is currently ongoing. This innovation may present an important advance facilitating enhanced minimally invasive mitral valve repair.

Le onzième volume des Metamorfosi dei Lumi explore le rôle crucial que la période de tournant des Lumières (1780-1820) joue dans la définition du concept moderne d’émotion. La dimension émotionnelle ne peut plus être étudiée dans ces années de manière abstraite, théorique, comme le demandaient les traités des passions du xviie siècle. Au contraire, cette dimension doit être inscrite dans l’expérience concrète. Les émotions naissent et se développent à travers un véritable choc, qui affecte de multiples niveaux d’investigation: à partir des relations interpersonnelles, dans lesquelles naissent et prennent forme les passions, jusqu’à la dimension publique, dans laquelle elles se configurent comme un ciment pour le lien social et un facteur de solidarité.

1. Sentir avant de penser: la perte de soi comme redécouverte de l’être Un jour d’automne au xviiie siècle: un homme de soixante ans se fraie un chemin à travers le tumulte parisien; passant à travers la foule affairée et le trafic urbain empli de son vacarme et de regards croisés, il parcourt les Grands Boulevards qui, à cette époque, définissaient la périphérie parisienne comme une ceinture serrée. Depuis les Boulevards, il quitte la ville; maintenant, il peut respirer à pleins poumons, il ...

The development of glass-ceramic materials is often achieved using an elementary microstructural strategy that splits the tasks of seed formation and functionality between two types of crystals. This strategy requires customized time-temperature ceramization protocols, which have been so far implemented using empirical parameters. Here, a more fundamental approach is proposed: the extent of overlap Oe between seed formation and volume crystallization is evaluated by calorimetric and dilatometric measurements, targeting the computation of a threshold heating rate qt for effective single-stage heat treatments. The applicability of this novel parameter is tested in TiO2-doped lithium magnesium aluminosilicate glass-ceramics, whose seed formation stage is thoroughly characterized by Raman spectroscopy and STEM. High-temperature X-ray diffraction demonstrates that insufficient seeding results in potentially weaker performances of the final products, due to large sizes and silica deficiency of the functional quartz solid solution crystals.

OBJECTIVES Despite promising short- and mid-term results for durability of the Trifecta valve, contradictory reports of early structural valve deterioration (SVD) do exist. We investigated the incidence of SVD after surgical aortic valve replacement (SAVR) with the Trifecta in our single-centre experience. METHODS Data of 347 consecutive patients (mean age 71.6 ± 9.5 years, 63.4% male) undergoing SAVR with the Trifecta between 2011 and 2017 were analysed. Clinical and echocardiographic reports were obtained with a median follow-up of 41 months (1114 patient years). RESULTS Isolated SAVR was performed in 122 patients (35.2%), whereas 225 patients (64.8%) underwent concomitant procedures. The median EuroSCORE II was 4.0 (0.9; 7.1) and 30-day mortality was 3.7% (n = 13). Kaplan–Meier estimates for the freedom of overall mortality at 1, 5 and 7 years were 88.7 ± 1.7%, 73.7 ± 2.6% and 64.7 ± 4.2%, respectively. SVD was observed in 25 patients (7.2%) with a median time to first diagnosis of 73 months. Freedom of SVD was 92.5 ± 0.9% at 5 years and 65.5 ± 7.1% at 7 years. Thirteen patients underwent reintervention for SVD (6 re-SAVR, 7 valve-in-valve), resulting in a freedom of reintervention for the SVD of 98.5 ± 1.1% at 5 years and 76.9 ± 6.9% at 7 years. CONCLUSIONS We herein report one of the highest rates of SVD after SAVR with the Trifecta. These data indicate that the durability of the prosthesis decreases at intermediate to long-term follow-up, leading to considerable rates of reintervention due to SVD.

Background There is a high coincidence of significant coronary artery disease and severe aortic stenosis. Coronary revascularization should be performed prior to transcatheter aortic valve implantation (TAVI). We report a case of non-ST-elevation myocardial infarction (NSTEMI) after complex percutaneous coronary intervention (PCI) prior to TAVI, where differential diagnosis between coronary stent failure and bioprosthesis-related sinus obstruction was substantial. Case summary A 79-year-old woman was re-admitted to the hospital 5 days after TAVI due to troponin-negative new-onset angina. She underwent complex PCI 3 days before TAVI and was not compliant to medications. Symptoms initially resolved after re-establishment of anti-hypertensive treatment. There were no signs of aortic bioprosthesis failure, paravalvular leak, or myocardial ischaemia. After 1 month, the symptoms re-occurred. Due to elevated troponins, myocardial ischaemia in electrocardiogram and new contractility disorders, NSTEMI was diagnosed. Because it was impossible to intubate the left coronary artery (LCA), cardiac surgery was performed. Calcified native coronary leaflet was pushed by the stent frame of aortic bioprosthesis towards LCA ostium causing its subtotal occlusion. Transcatheter heart valve (THV) was removed and the new surgical aortic bioprosthesis was implanted. Further hospitalization and 1-month follow-up were uneventful. Discussion Pre-procedural assessment is crucial prior to THV interventions. Delayed coronary obstruction caused by the native leaflet is extremely rare and potentially fatal complication of TAVI. The diagnosis is difficult and high clinical suspicion is required to detect this pathology. Given our experience, the indication towards interventional or surgical repair should be established faster to avoid coronary ischaemia.

OBJECTIVES A 3-dimensionally (3D) engineered model for simulation of aortic valve and proximal aortic procedures is a reliable tool both for training young surgeons and for simulating complex cases. To achieve a realistic simulation, the artificial model should reproduce the angles and orientations of the cardiac structures based on the patient’s anatomical condition, reproduce tissue mechanical characteristics and be easy to obtain and easy to use. The goal of the study was the production and validation of realistic training models, based on the patient’s actual anatomical characteristics, to provide training for aortic valve procedures. METHODS An anatomical model was manufactured using 3D printing and silicone casting. The digital anatomical model was obtained by segmenting computed tomography imaging. The segmented geometrical images were processed and a casting mould was designed. The mould was manufactured on a 3D printer. Silicone was cast into the mould; after curing, the finished model was ready. The realistic reproduction was evaluated by mechanical hardness tests and a survey by cardiac surgeons. RESULTS Six 3D silicone models were produced that represented the patient’s anatomy including aortic valve leaflets, aortic root with coronary ostia, ascending aorta and proximal arch. Aortic valve replacement was performed, and 100% of the participants evaluated the model in a survey as perfectly reproducing anatomy and surgical handling. CONCLUSIONS We produced a realistic, cost-effective simulator for training purposes and for simulation of complex surgical cases. The model reproduced the real angulation and orientation of the aortic structures inside the mediastinum, permitting a real-life simulation of the desired procedure. This model offers opportunities to simulate various surgical procedures.

Pump thrombosis (PT) is a serious adverse event in patients receiving left ventricular assist devices (LVAD). The study aims to determine whether pump parameters and clinical data may enable early detection of PT. This retrospective study included 88 patients who received an LVAD between 2012 and 2015 among which those with intra-PT were identified. In a propensity score-matched control group observation, time periods were matched with time before thrombosis. International normalized ratio (INR) time in therapeutic range (TTR) and lactate dehydrogenase (LDH) were analyzed for 60 days preceding PT. Furthermore, pump data (power, flow, and speed) in HeartWare ventricular assist devices (HVAD) patients were analyzed 7 days before PT using a mixed-design analysis of variance to investigate temporal changes in pump data. Pump thrombosis occurred in 15 patients (13 males, age 58 ± 10 years, 7 HeartMate II and 8 HVAD). International normalized ratio therapeutic range (2.0-3.0) and acetylsalicylic acid daily doses (100-200 mg) were similar for both groups, but patients with PT had lower TTR (36% vs. 65%; p = 0.025). No significant difference in LVAD power between groups was seen at baseline (p = 0.31), and power did not change in the control group over time (p > 0.99). Lactate dehydrogenase increased already 1 week prior PT and power from 4.4 ± 0.8 W at baseline to 4.9 ± 0.8 W (p = 0.007) 2 days before readmission and to 6.5 ± 1.8 W (p = 0.015) at readmission. Pump thrombosis is associated with a lower percentage of INR TTR and elevated LDH before the event. A better monitoring of pump parameters would enable PT detection already up to 2 days in advance.

Background: Chronic obstructive pulmonary disease (COPD) is one of the most common disorders in the world. COPD is characterized by airflow obstruction, which is not fully reversible. Patients usually experience breathing-related symptoms with periods of acute worsening and a substantial decrease in the health-related quality-of-life. Active and comprehensive disease management can slow down the progressive course of the disease and improve patients’ disabilities. Technological progress and digitalization of medicine have the potential to make elaborate interventions easily accessible and applicable to a broad spectrum of patients with COPD without increasing the costs of the intervention. Objective: This study aims to develop a comprehensive telemonitoring and hybrid virtual coaching solution and to investigate its effects on the health-related quality of life of patients with COPD. Methods: A monocentric, assessor-blind, two-arm (intervention/control) randomized controlled trial will be performed. Participants randomized to the control group will receive usual care and a CAir Desk (custom-built home disease-monitoring device to telemonitor disease-relevant parameters) for 12 weeks, without feedback or scores of the telemonitoring efforts and virtual coaching. Participants randomized to the intervention group will receive a CAir Desk and a hybrid digital coaching intervention for 12 weeks. As a primary outcome, we will measure the delta in the health-related quality of life, which we will assess with the St. George Respiratory Questionnaire, from baseline to week 12 (the end of the intervention). Results: The development of the CAir Desk and virtual coach has been completed. Recruitment to the trial started in September 2020. We expect to start data collection by December 2020 and expect it to last for approximately 18 months, as we follow a multiwave approach. We expect to complete data collection by mid-2022 and plan the dissemination of the results subsequently. Conclusions: To our knowledge, this is the first study investigating a combination of telemonitoring and hybrid virtual coaching in patients with COPD. We will investigate the effectiveness, efficacy, and usability of the proposed intervention and provide evidence to further develop app-based and chatbot-based disease monitoring and interventions in COPD. © 2020 JMIR Publications. All rights reserved., JMIR Research Protocols, 9 (10), ISSN:1929-0748

Transcatheter aortic valve replacement (TAVR) has rapidly become a viable alternative to the conventional isolated surgical aortic valve replacement (iSAVR) for treating severe symptomatic aortic stenosis. However, data on younger patients is scarce and a gap exists between data-based recommendations and the clinical use of TAVR. In our study, we utilized a machine learning (ML) driven approach to model the complex decision-making process of Heart Teams when treating young patients with severe symptomatic aortic stenosis with either TAVR or iSAVR and to identify the relevant considerations. Out of the considered factors, the variables most prominently featured in our ML model were congestive heart failure, established risk assessment scores, previous cardiac surgeries, a reduced left ventricular ejection fraction and peripheral vascular disease. Our study demonstrates a viable application of ML-based approaches for studying and understanding complex clinical decision-making processes.

BACKGROUND Research integrating multisensory home-monitoring in respiratory disease is scarce. Therefore, we created a novel multisensory home-monitoring device tailored for long-term respiratory disease management (named the CAir-Desk). We hypothesize that recent technological accomplishments can be integrated into a multisensory participant-driven platform. We also believe that this platform could improve chronic disease management and be accessible to large groups at an acceptable cost. OBJECTIVE This study aimed to report on user adherence and acceptance as well as system functionality of the CAir-Desk in a sample of participants with stable chronic obstructive pulmonary disease (COPD) or asthma. METHODS We conducted an observational usability study. Participants took part in 4 weeks of home-monitoring with the CAir-Desk. The CAir-Desk recorded data from all participants on symptom burden, physical activity, spirometry, and environmental air quality; data on sputum production, and nocturnal cough were only recorded for participants who experienced symptoms. After the study period, participants reported on their perceptions of the usability of the monitoring device through a purpose-designed questionnaire. We used descriptive statistics and visualizations to display results. RESULTS Ten participants, 5 with COPD and 5 with asthma took part in this study. They completed symptom burden questionnaires on a median of 96% (25th percentile 14%, 75th percentile 96%), spirometry recordings on 55% (20%, 94%), wrist-worn physical activity recordings on 100% (97%, 100%), arm-worn physical activity recordings on 45% (13%, 63%), nocturnal cough recordings on 34% (9%, 54%), sputum recordings on 5% (3%, 12%), and environmental air quality recordings on 100% (99%, 100%) of the study days. The participants indicated that the measurements consumed a median of 13 (10, 15) min daily, and that they preferred the wrist-worn physical activity monitor to the arm-worn physical activity monitor. CONCLUSIONS The CAir-Desk showed favorable technical performance and was well-accepted by our sample of participants with stable COPD and asthma. The obtained insights were used in a redesign of the CAir-Desk, which is currently applied in a randomized controlled trial including an interventional program.

Technological progress of left ventricular assist devices (LVADs) towards rotary blood pumps and the optimization of medical management contributed to the significant improvements in patient survival as well as LVAD support duration. Even though LVAD therapy is now well-established for end-stage heart failure patients, the long-term occurrence of adverse events (AE) such as bleeding, infection or stroke, still represent a relevant burden. An early detection of AE, before onset of major symptoms, can lead to further optimization of patient treatment and thus mitigate the burden of AE. Continuous patient monitoring facilitates identification of pathophysiological states and allows anticipation of AE to improve patient management. In this paper, methods, algorithms and possibilities for continuous patient monitoring based on LVAD data are reviewed. While experience with continuous LVAD monitoring is currently limited to a few centers worldwide, the pace of developments in this field is fast and we expect these technologies to have a global impact on the well-being of LVAD patients.

Background: In recent years, the number of people suffering from chronic conditions that require ongoing medical support reaching into the everyday lives of patients is constantly increasing. Global health systems are, however, not adequately equipped for this extraordinarily time-consuming and cost-intensive development. Here, conversational agents (CAs) can offer easily scalable and ubiquitous support. However, different aspects have not yet been sufficiently investigated to fully exploit their potential. One such trait is the interaction style between patients and CAs. In human-to-human settings, the interaction style is an imperative part of the relationship between patients and physicians. The patient-physician interaction is recognized as critical success factor for patient's satisfaction, treatment adherence, and subsequent treatment outcome. However, it remains so far effectively unknown how different interaction styles can be implemented into CA relationships and if these are recognizable by users. Objective: The objective of this paper is to develop an operationalization scheme to induce two specific interaction styles into CA-patient dialogues and subsequently test and validate them in a chronic healthcare context. Methods: Based on the Roter Interaction Analysis System (RIAS) and iterative evaluations by scientific experts and medical healthcare professionals, we identified 15 communication components that characterize the two operationalized interaction styles, i.e., the deliberative and paternalistic interaction style. These communication components were used to develop two CA variations, each representing one of the two interaction styles. We assessed them in an online between-subject experiment. Here, participants were asked to put themselves in the position of a patient suffering from chronic obstructive pulmonary disease (COPD). Participants were randomly assigned to interact with one of the two CAs and subsequently asked to identify the respective interaction style. A chi-square test was used to assess the correct identification of the CA-patient interaction style. Results: 88 individuals (48% female, mean age= 31.5 years) fulfilled the inclusion criteria and participated in the online experiment. Participants in both the paternalistic and deliberative condition correctly identified the underlying interaction style of the CAs in more than 80% of the assessments (X2 (1, 88) = 38.23, P = .000; rφ = .68). The validation of the operationalization scheme was hence successful. Conclusions: We developed an operationalization scheme tailored for a medical context to induce a paternalistic, respectively, deliberative interaction style into a written interaction between a patient and a CA. We successfully tested and validated the operationalization scheme in an online experiment with 88 participants. Future research should implement and test the operationalization scheme with actual chronic patients and compare results between medical conditions. The operationalization scheme can further be used as a starting point to develop dynamic CAs that adapt their interaction style to their users., Journal of Medical Internet Research, 23 (1), ISSN:1438-8871

Background: Conversational agents (CAs) for chronic disease management are receiving increasing attention in academia and the industry. However, long-term adherence to CAs is still a challenge and needs to be explored. Personalization of CAs has the potential to improve long-term adherence and, with it, user satisfaction, task efficiency, perceived benefits, and intended behavior change. Research on personalized CAs has already addressed different aspects, such as personalized recommendations and anthropomorphic cues. However, detailed information on interaction styles between patients and CAs in the role of medical health care professionals is scant. Such interaction styles play essential roles for patient satisfaction, treatment adherence, and outcome, as has been shown for physician-patient interactions. Currently, it is not clear (1) whether chronically ill patients prefer a CA with a paternalistic, informative, interpretive, or deliberative interaction style, and (2) which factors influence these preferences. Objective: We aimed to investigate the preferences of chronically ill patients for CA-delivered interaction styles. Methods: We conducted two studies. The first study included a paper-based approach and explored the preferences of chronic obstructive pulmonary disease (COPD) patients for paternalistic, informative, interpretive, and deliberative CA-delivered interaction styles. Based on these results, a second study assessed the effects of the paternalistic and deliberative interaction styles on the relationship quality between the CA and patients via hierarchical multiple linear regression analyses in an online experiment with COPD patients. Patients’ sociodemographic and disease-specific characteristics served as moderator variables. Results: Study 1 with 117 COPD patients revealed a preference for the deliberative (50/117) and informative (34/117) interaction styles across demographic characteristics. All patients who preferred the paternalistic style over the other interaction styles had more severe COPD (three patients, Global Initiative for Chronic Obstructive Lung Disease class 3 or 4). In Study 2 with 123 newly recruited COPD patients, younger participants and participants with a less recent COPD diagnosis scored higher on interaction-related outcomes when interacting with a CA that delivered the deliberative interaction style (interaction between age and CA type: relationship quality: b=−0.77, 95% CI −1.37 to −0.18; intention to continue interaction: b=−0.49, 95% CI −0.97 to −0.01; working alliance attachment bond: b=−0.65, 95% CI −1.26 to −0.04; working alliance goal agreement: b=−0.59, 95% CI −1.18 to −0.01; interaction between recency of COPD diagnosis and CA type: working alliance goal agreement: b=0.57, 95% CI 0.01 to 1.13). Conclusions: Our results indicate that age and a patient’s personal disease experience inform which CA interaction style the patient should be paired with to achieve increased interaction-related outcomes with the CA. These results allow the design of personalized health care CAs with the goal to increase long-term adherence to health-promoting behavior. --> Background: Conversational agents (CAs) for chronic disease management are receiving increasing attention in academia and the industry. However, long-term adherence to CAs is still a challenge and needs to be explored. Personalization of CAs has the potential to improve long-term adherence and, with it, user satisfaction, task efficiency, perceived benefits, and intended behavior change. Research on personalized CAs has already addressed different aspects, such as personalized recommendations and anthropomorphic cues. However, detailed information on interaction styles between patients and CAs in the role of medical health care professionals is scant. Such interaction styles play essential roles for patient satisfaction, treatment adherence, and outcome, as has been shown for physician-patient interactions. Currently, it is not clear (1) whether chronically ill patients prefer a CA with a paternalistic, informative, interpretive, or deliberative interaction style, and (2) which factors influence these preferences. Objective: We aimed to investigate the preferences of chronically ill patients for CA-delivered interaction styles. Methods: We conducted two studies. The first study included a paper-based approach and explored the preferences of chronic obstructive pulmonary disease (COPD) patients for paternalistic, informative, interpretive, and deliberative CA-delivered interaction styles. Based on these results, a second study assessed the effects of the paternalistic and deliberative interaction styles on the relationship quality between the CA and patients via hierarchical multiple linear regression analyses in an online experiment with COPD patients. Patients’ sociodemographic and disease-specific characteristics served as moderator variables. Results: Study 1 with 117 COPD patients revealed a preference for the deliberative (50/117) and informative (34/117) interaction styles across demographic characteristics. All patients who preferred the paternalistic style over the other interaction styles had more severe COPD (three patients, Global Initiative for Chronic Obstructive Lung Disease class 3 or 4). In Study 2 with 123 newly recruited COPD patients, younger participants and participants with a less recent COPD diagnosis scored higher on interaction-related outcomes when interacting with a CA that delivered the deliberative interaction style (interaction between age and CA type: relationship quality: b=−0.77, 95% CI −1.37 to −0.18; intention to continue interaction: b=−0.49, 95% CI −0.97 to −0.01; working alliance attachment bond: b=−0.65, 95% CI −1.26 to −0.04; working alliance goal agreement: b=−0.59, 95% CI −1.18 to −0.01; interaction between recency of COPD diagnosis and CA type: working alliance goal agreement: b=0.57, 95% CI 0.01 to 1.13). Conclusions: Our results indicate that age and a patient’s personal disease experience inform which CA interaction style the patient should be paired with to achieve increased interaction-related outcomes with the CA. These results allow the design of personalized health care CAs with the goal to increase long-term adherence to health-promoting behavior., Journal of Medical Internet Research, 23 (5), ISSN:1438-8871