Search

Purpose The purpose of this study was to compare the effect of varying levels of assist during pressure support (PSV) and Neurally Adjusted Ventilatory Assist (NAVA) on the aeration of the dependent and non-dependent lung regions by means of Electrical Impedance Tomography (EIT). Methods We studied ten mechanically ventilated patients with Acute Lung Injury (ALI). Positive-End Expiratory Pressure (PEEP) and PSV levels were both 10 cm H.sub.2O during the initial PSV step. Thereafter, we changed the inspiratory pressure to 15 and 5 cm H.sub.2O during PSV. The electrical activity of the diaphragm (EAdi) during pressure support ten was used to define the initial NAVA gain (100 %). Thereafter, we changed NAVA gain to 150 and 50 %, respectively. After each step the assist level was switched back to PSV 10 cm H.sub.2O or NAVA 100 % to get a new baseline. The EIT registration was performed continuously. Results Tidal impedance variation significantly decreased during descending PSV levels within patients, whereas not during NAVA. The dorsal-to-ventral impedance distribution, expressed according to the center of gravity index, was lower during PSV compared to NAVA. Ventilation contribution of the dependent lung region was equally in balance with the non-dependent lung region during PSV 5 cm H.sub.2O, NAVA 50 and 100 %. Conclusion Neurally Adjusted Ventilatory Assist ventilation had a beneficial effect on the ventilation of the dependent lung region and showed less over-assistance compared to PSV in patients with ALI., Author(s): Paul Blankman [sup.1], Djo Hasan [sup.2], Martijn S. van Mourik [sup.3], Diederik Gommers [sup.1] Author Affiliations: (1) grid.5645.2, 000000040459992X, Department of Intensive Care Adults, Erasmus MC Rotterdam, , Room [...]

Background: The timing of onset and associated predictors of late new conduction disturbances (CDs) leading to permanent pacemaker implantation (PPI) following transcatheter aortic valve implantation (TAVI) are still unknown, however, essential for an early and safe discharge. This study aimed to investigate the timing of onset and associated predictors of late onset CDs in patients requiring PPI (LCP) following TAVI.Methods and Results: We performed retrospective analysis of prospectively collected data from five large volume centres in Europe. Post-TAVI electrocardiograms and telemetry data were evaluated in patients with a PPI post-TAVI to identify the onset of new advanced CDs. Early onset CDs were defined as within 48 hours after procedure, and late onset CDs as after 48 hours. A total of 2804 patients were included for analysis. The PPI rate was 12%, of which 18% was due to late onset CDs (>48 hours). Independent predictors for LCP were pre-existing non-specific intraventricular conduction delay, pre-existing right bundle branch block, self-expandable valves and predilation. At least one of these risk factors was present in 98% of patients with LCP. Patients with a balloon-expandable valve without predilation did not develop CDs requiring PPI after 48 hours.Conclusions: Safe early discharge might be feasible in patients without CDs in the first 48 hours after TAVI if no risk factors for LCP are present. [ABSTRACT FROM AUTHOR]

Background: There is an increasing trend towards shorter hospital stays after transcatheter aortic valve implantation (TAVI), in particular for patients undergoing the procedure via transfemoral (TF) access. Preliminary data suggest that there exists a population of patients that can be discharged safely very early after TF-TAVI. However, current evidence is limited to few retrospective studies, encompassing relatively small sample sizes.Methods: The Feasibility And Safety of early discharge after Transfemoral TAVI (FAST-TAVI) registry is a prospective observational registry that will be conducted at 10 sites across Italy, the Netherlands and the UK. Patients will be included if they have been scheduled to undergo TF-TAVI with the balloon-expandable SAPIEN 3 transcatheter heart valve (THV; Edwards Lifesciences, Irvine, CA). The primary endpoint is a composite of all-cause mortality, vascular-access-related complications, permanent pacemaker implantation, stroke, re-hospitalisation due to cardiac reasons, kidney failure and major bleeding, occurring during the first 30 days after hospital discharge. Patients will be stratified according to whether they were high or low risk for early discharge (≤3 days) (following pre-specified criteria), and according to whether or not they were discharged early. Secondary endpoints will include time-to-event (Kaplan-Meier) analysis for the primary outcome and its individual components, analysis of the relative costs of early and late discharge, and changes in short- and long-term quality of life. Multivariate logistic regression will be used to identify factors that indicate that a patient may be suitable for early discharge.Discussion: The data gathered in the FAST-TAVI registry should help to clarify the safety of early discharge after TF-TAVI and to identify patient and procedural characteristics that make early discharge from hospital a safe and cost-effective strategy.Trial Registration: ClinicalTrials.gov Identifier: NCT02404467 (registration first received March 23rd 2015). [ABSTRACT FROM AUTHOR]

Background: Transcatheter aortic valve implantation (TAVI) is a well-established treatment for patients with severe aortic valve stenosis. This procedure requires pre-operative planning by assessment of aortic dimensions on CT Angiography (CTA). It is well-known that the aortic root dimensions vary over the heart cycle. However, sizing is commonly performed at either mid-systole or end-diastole only, which has resulted in an inadequate understanding of its full dynamic behavior. Study goal: We studied the variation in annulus measurements during the cardiac cycle and determined if this variation is dependent on the amount of calcification at the annulus. Methods: We measured and compared aortic root annular dimensions and calcium volume in CTA acquisitions at 10 cardiac cycle phases in 51 aortic stenosis patients. Sub-group analysis was performed based on the volume of calcium by splitting the population into mildly and severely calcified valves subgroups. Results: For most annulus measurements, the largest differences were found between 10% and 70 to 80% cardiac cycle phases. Mean difference (±standard deviation) in annular minimum diameter, maximum diameter, area, and aspect ratio between mid-systole and end-diastole phases were 1.0 ± 0.29 mm (p = 0.065), 0.30 ± 0.24 mm (p = 0.7), 24.1 ± 7.6 mm2 (p < 0.001), and 0.041 ± 0.012 (p = 0.039) respectively. Calcium volume measurements varied strongly during the cardiac cycle. The dynamic annulus area was behaving differently between mildly and severely calcified subgroups (p = 0.02). Furthermore, patients with severe aortic calcification were associated with larger annulus diameters. Conclusion: There is a significant variation of annulus area and calcium volume measurement during the cardiac cycle. In our measurements, only the dynamic variation of the annulus area is dependent on the severity of the aortic calcification. For TAVI candidates, the annulus area is significantly larger in mid-systole compared to end-diastole. [ABSTRACT FROM AUTHOR]

Over the past decade transcatheter aortic valve implantation (TAVI) has evolved towards the routine therapy for high-risk patients with severe aortic valve stenosis. Technical refinements in TAVI are rapidly evolving with a simultaneous expansion of the number of available devices. This review will present an overview of the current status of development of TAVI-prostheses; describes the technical features and applicability of each device and the clinical data available. [ABSTRACT FROM PUBLISHER]

Background: To analyze the organization of multidisciplinary care pathways such as colorectal cancer care, an instrument was developed based on a recently published framework that was earlier used in analyzing (monodisciplinary) specialist cataract care from a lean perspective. Methods: The instrument was constructed using semi-structured interviews and direct observation of the colorectal care process based on a Rapid Plant Assessment. Six lean aspects that were earlier established that highly impact process design, were investigated: operational focus, autonomous work cell, physical lay-out of resources, multi-skilled team, pull planning and non-value adding activities. To test reliability, clarity and face validity of the instrument, a pilot study was performed in eight Dutch hospitals. Results: In the pilot it proved feasible to apply the instrument and generate the intended information. The instrument consisted of 83 quantitative and 24 qualitative items. Examples of results show differences in operational focus, number of patient visits needed for diagnosis, numbers of staff involved with treatment, the implementation of protocols and utilization of one-stop-shops. Identification of waste and non-value adding activities may need further attention. Based on feedback from involved clinicians the face validity was acceptable and the results provided useful feedback- and benchmark data. The instrument proved to be reliable and valid for broader implementation in Dutch health care. The limited number of cases made statistical analysis not possible and further validation studies may shed better light on variation. Conclusions: This paper demonstrates the use of an instrument to analyze organizational characteristics in colorectal cancer care from a lean perspective. Wider use might help to identify best organizational practices for colorectal surgery. In larger series the instrument might be used for in-depth research into the relation between organization and patient outcomes. Although we found no reason to adapt the underlying framework, recommendations were made for further development to enable use in different tumor- and treatment modalities and in larger (international) samples that allow for more advanced statistical analysis. Waste from defective care or from wasted human potential will need further elaboration of the instrument. [ABSTRACT FROM AUTHOR]

Background: Decreasing the amount of iodinated contrast is an important safety aspect of percutaneous coronary interventions (PCI), particularly in patients with a high risk of contrast-induced acute kidney injury (CI-AKI). Dynamic Coronary Roadmap (DCR) is a PCI navigation support tool projecting a motion-compensated virtual coronary roadmap overlay on fluoroscopy, potentially limiting the need for contrast during PCI., Aims: This study investigates the contrast-sparing potential of DCR in PCI, compared to standard angiographic guidance., Methods: The Dynamic Coronary Roadmap for Contrast Reduction (DCR4Contrast) trial is a multicentre, international, prospective, unblinded, stratified 1:1 randomised controlled trial. Patients were randomised to either DCR-guided PCI or to conventional angiography-guided PCI. The primary endpoint was the total volume of iodinated contrast administered, and the secondary endpoint was the number of cineangiography runs during PCI., Results: The study population included 356 randomised patients (179 in DCR and 177 in control groups, respectively). There were no differences in patient demographics, angiographic characteristics or estimated glomerular filtration rate (eGFR) between the two groups. The total contrast volume used during PCI was significantly lower with DCR guidance compared with conventional angiographic guidance (64.6±44.4 ml vs 90.8±55.4 ml, respectively; p<0.001). The total number of cineangiography runs was also significantly reduced in the DCR group (8.7±4.7 vs 11.7±7.6 in the control group; p<0.001)., Conclusions: Compared to conventional angiography-guided PCI, DCR guidance was associated with a significant reduction in both contrast volume and the number of cineangiography runs during PCI. (ClinicalTrials.gov: NCT04085614).

Background: TAVI has shown to result in immediate and sustained hemodynamic alterations and improvement in health-related quality of life (HRQoL), but previous studies have been suboptimal to predict who might benefit from TAVI. The relationship between immediate hemodynamic changes and outcome has not been studied before. This study sought to assess whether an immediate hemodynamic change, reflecting myocardial contractile reserve, following TAVI is associated with improved HRQoL. Furthermore, it assessed whether pre-procedural cardiac power index (CPI) and left ventricular ejection fraction (LVEF) could predict these changes., Methods: During the TAVI procedure, blood pressure and systemic hemodynamics were prospectively collected with a Nexfin ® non-invasive monitor. HRQoL was evaluated pre-procedurally and 12 weeks after the procedure, using the EQ-5D-5L classification tool., Results: Overall, 97/114 (85%) of the included patients were eligible for analyses. Systolic, diastolic and mean arterial pressure, heart rate, and stroke volume increased immediately after TAVI (all p < 0.005), and left ventricular ejection time (LVET) immediately decreased with 10 ms (95%CI = -4 to -16, p < 0.001). Overall HRQoL index increased from 0.810 [0.662-0.914] before to 0.887 [0.718-0.953] after TAVI ( p = 0.016). An immediate decrease in LVET was associated with an increase in HRQoL index (0.02 index points per 10 ms LVET decrease, p = 0.041). Pre-procedural CPI and LVEF did not predict hemodynamic changes or change in HRQoL., Conclusion: TAVI resulted in an immediate hemodynamic response and increase in HRQoL. Immediate reduction in LVET, suggesting unloading of the ventricle, was associated with an increase in HRQoL, but neither pre-procedural CPI nor LVEF predicted these changes., Clinical Trial Registration: https://clinicaltrials.gov/ct2/show/NCT03088787., Competing Interests: Author AV has received personal fees and other from Edwards Lifesciences and Philips outside the submitted work. Author RI has received a grant from Edwards Lifesciences outside the submitted work. Author JB has received a grant from Edwards Lifesciences outside the submitted work. Author DV has received personal fees and other from Edwards Lifesciences, Philips and Hemologic outside the submitted work. The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2022 Schenk, Kho, Rellum, Kromhout, Vlaar, Baan, van Mourik, Jorstad, van der Ster, Westerhof, Bruns, Immink, Vis and Veelo.)

Background: Manual muscle mass assessment based on Computed Tomography (CT) scans is recognized as a good marker for malnutrition, sarcopenia, and adverse outcomes. However, manual muscle mass analysis is cumbersome and time consuming. An accurate fully automated method is needed. In this study, we evaluate if manual psoas annotation can be substituted by a fully automatic deep learning-based method., Methods: This study included a cohort of 583 patients with severe aortic valve stenosis planned to undergo Transcatheter Aortic Valve Replacement (TAVR). Psoas muscle area was annotated manually on the CT scan at the height of lumbar vertebra 3 (L3). The deep learning-based method mimics this approach by first determining the L3 level and subsequently segmenting the psoas at that level. The fully automatic approach was evaluated as well as segmentation and slice selection, using average bias 95% limits of agreement, Intraclass Correlation Coefficient (ICC) and within-subject Coefficient of Variation (CV). To evaluate performance of the slice selection visual inspection was performed. To evaluate segmentation Dice index was computed between the manual and automatic segmentations (0 = no overlap, 1 = perfect overlap)., Results: Included patients had a mean age of 81 ± 6 and 45% was female. The fully automatic method showed a bias and limits of agreement of -0.69 [-6.60 to 5.23] cm 2 , an ICC of 0.78 [95% CI: 0.74-0.82] and a within-subject CV of 11.2% [95% CI: 10.2-12.2]. For slice selection, 84% of the selections were on the same vertebra between methods, bias and limits of agreement was 3.4 [-24.5 to 31.4] mm. The Dice index for segmentation was 0.93 ± 0.04, bias and limits of agreement was -0.55 [1.71-2.80] cm 2 ., Conclusion: Fully automatic assessment of psoas muscle area demonstrates accurate performance at the L3 level in CT images. It is a reliable tool that offers great opportunities for analysis in large scale studies and in clinical applications., Competing Interests: PM was employed by Quantib-U. BD was Artificial Intelligence lead and cofounder of Quantib-U. II was a cofounder and Scientific lead at Quantib-U. The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2022 Van Erck, Moeskops, Schoufour, Weijs, Scholte Op Reimer, Van Mourik, Janmaat, Planken, Vis, Baan, Hemke, Išgum, Henriques, De Vos and Delewi.)

Background: Machine learning models have been developed for numerous medical prognostic purposes. These models are commonly developed using data from single centers or regional registries. Including data from multiple centers improves robustness and accuracy of prognostic models. However, data sharing between multiple centers is complex, mainly because of regulations and patient privacy issues. Objective: We aim to overcome data sharing impediments by using distributed ML and local learning followed by model integration. We applied these techniques to develop 1-year TAVI mortality estimation models with data from two centers without sharing any data. Methods: A distributed ML technique and local learning followed by model integration was used to develop models to predict 1-year mortality after TAVI. We included two populations with 1,160 (Center A) and 631 (Center B) patients. Five traditional ML algorithms were implemented. The results were compared to models created individually on each center. Results: The combined learning techniques outperformed the mono-center models. For center A, the combined local XGBoost achieved an AUC of 0.67 (compared to a mono-center AUC of 0.65) and, for center B, a distributed neural network achieved an AUC of 0.68 (compared to a mono-center AUC of 0.64). Conclusion: This study shows that distributed ML and combined local models techniques, can overcome data sharing limitations and result in more accurate models for TAVI mortality estimation. We have shown improved prognostic accuracy for both centers and can also be used as an alternative to overcome the problem of limited amounts of data when creating prognostic models., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2021 Lopes, Mamprin, Zelis, Tonino, van Mourik, Vis, Zinger, de Mol, de With and Marquering.)

Current prognostic risk scores for transcatheter aortic valve implantation (TAVI) do not benefit yet from modern machine learning techniques, which can improve risk stratification of one-year mortality of patients before TAVI. Despite the advancement of machine learning in healthcare, data sharing regulations are very strict and typically prevent exchanging patient data, without the involvement of ethical committees. A very robust validation approach, including 1300 and 631 patients per center, was performed to validate a machine learning model of one center at the other external center with their data, in a mutual fashion. This was achieved without any data exchange but solely by exchanging the models and the data processing pipelines. A dedicated exchange protocol was designed to evaluate and quantify the model's robustness on the data of the external center. Models developed with the larger dataset offered similar or higher prediction accuracy on the external validation. Logistic regression, random forest and CatBoost lead to areas under curve of the ROC of 0.65, 0.67 and 0.65 for the internal validation and of 0.62, 0.66, 0.68 for the external validation, respectively. We propose a scalable exchange protocol which can be further extended on other TAVI centers, but more generally to any other clinical scenario, that could benefit from this validation approach.

Aims: Treatment pathway optimisation in TAVI should include timely patient discharge with a minimised risk for out-of-hospital adverse events. The aim of this study was to define a standardised set of risk criteria that allows a safe and timely discharge, to validate their appropriateness prospectively in different centres and multiple European countries, and to assess post-discharge outcomes., Methods and Results: We defined and validated the adequacy of a set of discharge criteria and its ability to predict timely and safe discharge properly after the intervention in a prospective, European, multicentre registry. A total of 502 unselected patients were enrolled at 10 sites in three countries. The primary endpoint, defined as a composite of all-cause mortality, vascular access-related complications, permanent pacemaker implantation, stroke, re-hospitalisation due to cardiac reasons, kidney failure and major bleeding at 30 days, was reached in 12.9% of patients (95% CI: 11.3-16.5). The overall 30-day mortality was 1.1% (95% CI: 0.2-2.0), and the rates of stroke/TIA 1.7% (95% CI: -0.6 to 4.0), PPI 7.3% (95% CI: 5.8-8.9), major vascular complications 1.9% (95% CI: 0.7-3.1), major/life-threatening bleeding 2.4% (95% CI: 1.0-3.8) and cardiac re-hospitalisation 3.7% (95% CI: 1.4-6.0). Patients appropriately discharged early had a significantly lower risk of the primary endpoint (7.0 vs. 26.4%; p<0.001) which was reflected in some of its relevant components: stroke (0.0 vs. 2.8%; p=0.015), PPI (4.3 vs. 15.9%; p<0.001), major vascular complications (0.3 vs. 4.7%; p=0.004) and major/life-threatening bleeding (0.3 vs. 6.5%; p<0.001)., Conclusions: We validated the appropriateness of a pre-specified set of risk criteria that allows a safe and timely discharge. The rate of 30-day complications did not reveal any risk increase with this strategy compared with the reported outcomes in major TAVI trials and registries. ClinicalTrials.gov Identifier: NCT02404467.

Background: In a three-month report from the CGA-TAVI registry, we found the Multidimensional Prognostic Index (MPI) and Short Physical Performance Battery (SPPB) to be of value for predicting short-term outcomes in elderly patients undergoing transcatheter aortic valve implantation (TAVI). In the present analysis, we examined the association of these tools with outcomes up to one year post-TAVI., Methods: CGA-TAVI is an international, observational registry of geriatric patients undergoing TAVI. Patients were assessed using the MPI and SPPB. Efficacy of baseline values and any postoperative change for predicting outcome were established using logistic regression. Kaplan-Meier analysis was carried out for each comprehensive geriatric assessment tool, with survival stratified by risk category., Results: One year after TAVI, 14.1% of patients deceased, while 17.4% met the combined endpoint of death and/or non-fatal stroke, and 37.7% the combined endpoint of death and/or hospitalisation and/or non-fatal stroke. A high-risk MPI score was associated with an increased risk of all-cause mortality (aOR = 36.13, 95% CI: 2.77-470.78, P = 0.006) and death and/or non-fatal stroke (aOR = 10.10, 95% CI: 1.48-68.75, P = 0.018). No significant associations were found between a high-risk SPPB score and mortality or two main combined endpoints. In contrast to a worsening SPPB, an aggravating MPI score at three months post-TAVI was associated with an increased risk of death and/or non-fatal stoke at one year (aOR = 95.16, 95% CI: 3.41-2657.01)., Conclusions: The MPI showed value for predicting the likelihood of death and a combination of death and/or non-fatal stroke by one year after TAVI in elderly patients.

Background: The postprocedural trajectory of patients undergoing transcatheter aortic valve replacement (TAVR) involves in-hospital monitoring of potential cardiac rhythm or conduction disorders and other complications. Recent advances in telemonitoring technologies create opportunities to monitor electrocardiogram (ECG) and vital signs remotely, facilitating redesign of follow-up trajectories., Objective: This study aimed to outline a potential set-up of telemonitoring after TAVR., Methods: A multidisciplinary team systematically framed the envisioned telemonitoring scenario according to the intentions, People, Activities, Context, Technology (iPACT) and Functionality, Interaction, Content, Services (FICS) methods and identified corresponding technical requirements., Results: In this scenario, a wearable sensor system is used to continuously transmit ECG and contextual data to a central monitoring unit, allowing remote follow-up of ECG abnormalities and physical deteriorations. Telemonitoring is suggested as an alternative or supplement to current in-hospital monitoring after TAVR, enabling early hospital dismissal in eligible patients and accessible follow-up prolongation. Together, this approach aims to improve rehabilitation, enhance patient comfort, optimize hospital capacity usage, and reduce overall costs. Required technical components include continuous data acquisition, real-time data transfer, privacy-ensured storage, automatic event detection, and user-friendly interfaces., Conclusions: The suggested telemonitoring set-up involves a new approach to patient follow-up that could bring durable solutions for the growing scarcities in health care and for improving health care quality. To further explore the potential and feasibility of post-TAVR telemonitoring, we recommend evaluation of the overall impact on patient outcomes and of the safety, social, ethical, legal, organizational, and financial factors., (©Mathilde C Hermans, Martijn S Van Mourik, Hermie J Hermens, Jan Baan Jr, Marije M Vis. Originally published in JMIR Cardio (http://cardio.jmir.org), 16.03.2018.)