Final 5-year report of BIONYX comparing the thin-composite wire-strut zotarolimus-eluting stent versus ultrathin-strut sirolimus-eluting stent.

BACKGROUND: The BIONYX randomized trial is the first study to evaluate the Resolute Onyx durable polymer-coated zotarolimus-eluting stent (ZES) in all-comers. Furthermore, it is the first trial to assess safety and efficacy of this stent versus the Orsiro biodegradable-polymer sirolimus-eluting stent (SES) in all-comers, paying particular attention to patients with diabetes. It has previously shown promising results until 3 years of follow-up. AIMS: We aimed to assess long-term clinical outcome after percutaneous coronary intervention (PCI) with Onyx ZES versus Orsiro SES at 5-year follow-up. METHODS: The main composite endpoint was target vessel failure (TVF): cardiac death, target vessel myocardial infarction, or target vessel revascularization. Time to primary and secondary endpoints was assessed using Kaplan-Meier methods, applying the log-rank test for between-group comparison. RESULTS: Follow-up was available in 2414/2488 (97.0%) patients. After 5 years, TVF showed no significant difference between Onyx ZES and Orsiro SES (12.7% vs. 13.7%, hazard ratio [HR] 0.94, 95% confidence interval [CI] [0.75-1.17], plog-rank = 0.55). Landmark analysis between 3- and 5-year follow-up found a lower target lesion revascularization rate for Onyx ZES (1.1% vs. 2.4%, HR 0.47, 95% CI [0.24-0.93], plog-rank = 0.026). A prespecified subgroup analysis showed no significant between-stent difference in clinical outcome among patients with diabetes. After treatment with Onyx ZES, patients aged ≥75 years had significantly lower rates of TVF (13.8% vs. 21.9%, HR 0.60, 95% CI [0.39-0.93], plog-rank = 0.023). CONCLUSIONS: The final 5-year analysis of the randomized BIONYX trial showed favorable and similar long-term outcomes of safety and efficacy for Onyx ZES and Orsiro SES in both all-comers and patients with diabetes.

Intra- and interobserver reliability in measuring aortic root rotation with cardiac magnetic resonance imaging.

Background: The rotational position of the aortic root (AoR) is of substantial clinical interest as it has been associated with severe aortic complications, such as aortic dissections. We described a cardiac magnetic resonance (CMR)-based method for measuring AoR rotation and evaluated the reliability of measurements. Methods: CMR was used for measuring AoR rotation in 50 consecutive healthy subjects. Intra- and interobserver reliability were assessed by comparing repeated measurements by the same analyst and by three independent analysts. The angles of the non-coronary sinus (NCS), right coronary sinus (RCS), and left coronary sinus (LCS) were measured relative to the interatrial septum (IAS). The angle between IAS and posterior atrial wall was measured to examine the reliability of the IAS as a key anatomical landmark. Intra- and interobserver agreement were determined using intraclass correlation coefficients (ICCs). Results: Images of 47/50 (94%) subjects were analyzed; three were excluded due to insufficient image quality. The mean ± standard deviation (SD) AoR rotation angles of NCS, RCS, and LCS were 25.9°±12.9°, 37.5°±15.2°, and 97.0°±13.1°, respectively. For measurements of AoR rotation, both intraobserver [NCS: ICC =0.94, 95% confidence interval (CI): 0.88-0.96; RCS: ICC =0.93, 95% CI: 0.87-0.96; LCS: ICC =0.91, 95% CI: 0.84-0.95] and interobserver agreement (NCS: ICC =0.90, 95% CI: 0.84-0.94; RCS: ICC =0.86, 95% CI: 0.77-0.92; LCS: ICC =0.87, 95% CI: 0.80-0.92) were excellent. The IAS angle was 79.2°±8.9°; its intraobserver agreement was somewhat higher (ICC =0.94, 95% CI: 0.88-0.96) than the interobserver agreement (ICC =0.76, 95% CI: 0.63-0.85). Conclusions: The present study in healthy subjects reports a CMR-based approach for measuring AoR rotation. CMR allows to quantify AoR rotation with excellent intra- and interobserver agreement.

Ethnic minorities treated with new-generation drug-eluting coronary stents in two European randomised clinical trials.

BACKGROUND: Several ethnic minorities have an increased risk of cardiovascular events, but previous European trials that investigated clinical outcome after coronary stenting did not assess the patients' ethnic background. AIMS: To compare ethnic minority and Western European trial participants in terms of both cardiovascular risk profile and 1­year clinical outcome after percutaneous coronary intervention. METHODS: In the BIO-RESORT and BIONYX randomised trials, which assessed new-generation drug-eluting stents, information on patients' self-reported ethnic background was prospectively collected. Pooled patient-level data of 5803 patients, enrolled in the Netherlands and Belgium, were analysed in this prespecified analysis. The main endpoint was target vessel failure after 1 year. RESULTS: Patients were classified as belonging to an ethnic minority (n = 293, 5%) or of Western European origin (n = 5510, 95%). Follow-up data were available in 5772 of 5803 (99.5%) patients. Ethnic minority patients were younger, less often female, more often current smokers, more often medically treated for diabetes, and more often had a positive family history of coronary artery disease. The main endpoint target vessel failure did not differ between ethnic minority and Western European patients (3.5% vs 4.9%, hazard ratio 0.71, 95% confidence interval 0.38-1.33; p = 0.28). There was also no difference in mortality, myocardial infarction, and repeat revascularisation rates. CONCLUSIONS: Despite the unfavourable cardiovascular risk profile of ethnic minority patients, short-term clinical outcome after treatment with contemporary drug-eluting stents was highly similar to that in Western European patients. Further efforts should be made to ensure the enrolment of more ethnic minority patients in future coronary stent trials.

Enhancing discharge decision-making through continuous monitoring in an acute admission ward: a randomized controlled trial.

In Acute Admission Wards, vital signs are commonly measured only intermittently. This may result in failure to detect early signs of patient deterioration and impede timely identification of patient stability, ultimately leading to prolonged stays and avoidable hospital admissions. Therefore, continuous vital sign monitoring may improve hospital efficacy. The objective of this randomized controlled trial was to evaluate the effect of continuous monitoring on the proportion of patients safely discharged home directly from an Acute Admission Ward. Patients were randomized to either the control group, which received usual care, or the sensor group, which additionally received continuous monitoring using a wearable sensor. The continuous measurements could be considered in discharge decision-making by physicians during the daily bedside rounds. Safe discharge was defined as no unplanned readmissions, emergency department revisits or deaths, within 30 days after discharge. Additionally, length of stay, the number of Intensive Care Unit admissions and Rapid Response Team calls were assessed. In total, 400 patients were randomized, of which 394 completed follow-up, with 196 assigned to the sensor group and 198 to the control group. The proportion of patients safely discharged home was 33.2% in the sensor group and 30.8% in the control group (p = 0.62). No significant differences were observed in secondary outcomes. The trial was terminated prematurely due to futility. In conclusion, continuous monitoring did not have an effect on the proportion of patients safely discharged from an Acute Admission Ward. Implementation challenges of continuous monitoring may have contributed to the lack of effect observed. Trial registration: https://clinicaltrials.gov/ct2/show/NCT05181111 . Registered: January 6, 2022.

Lack of Evidence Regarding Markers Identifying Acute Heart Failure in Patients with COPD: An AI-Supported Systematic Review.

Background: Due to shared symptoms, acute heart failure (AHF) is difficult to differentiate from an acute exacerbation of COPD (AECOPD). This systematic review aimed to identify markers that can diagnose AHF underlying acute dyspnea in patients with COPD presenting at the hospital. Methods: All types of observational studies and clinical trials that investigated any marker's ability to diagnose AHF in acutely dyspneic COPD patients were considered eligible for inclusion. An AI tool (ASReview) supported the title and abstract screening of the articles obtained from PubMed, Scopus, Web of Science, the Cochrane Library, Embase, and CINAHL until April 2023. Full text screening was independently performed by two reviewers. Twenty percent of the data extraction was checked by a second reviewer and the risk of bias was assessed in duplicate using the QUADAS-2 tool. Markers' discriminative abilities were evaluated in terms of sensitivity, specificity, positive and negative predictive values, and the area under the curve when available. Results: The search identified 10,366 articles. After deduplication, title and abstract screening was performed on 5,386 articles, leaving 153 relevant, of which 82 could be screened full text. Ten distinct studies (reported in 16 articles) were included, of which 9 had a high risk of bias. Overall, these studies evaluated 12 distinct laboratory and 7 non-laboratory markers. BNP, NT-proBNP, MR-proANP, and inspiratory inferior vena cava diameter showed the highest diagnostic discrimination. Conclusion: There is not much evidence for the use of markers to diagnose AHF in acutely dyspneic COPD patients in the hospital setting. BNPs seem most promising, but should be interpreted alongside imaging and clinical signs, as this may lead to improved diagnostic accuracy. Future validation studies are urgently needed before any AHF marker can be incorporated into treatment decision-making algorithms for patients with COPD. Protocol Registration: CRD42022283952.

Invasiveness of previous treatment for peripheral arterial disease and risk of adverse cardiac events after coronary stenting.

Patients with peripheral arterial disease (PADs), undergoing percutaneous coronary intervention (PCI), have higher adverse event risks. The effect of invasiveness of PADs treatment on PCI outcome is unknown. This study assessed the impact of the invasiveness of previous PADs treatment (invasive or non-invasive) on event risks after PCI with contemporary drug-eluting stents. This post-hoc analysis pooled 3-year patient-level data of PCI all-comer patients living in the eastern Netherlands, previously treated for PADs. PADs included symptomatic atherosclerotic lesion in the lower or upper extremities; carotid or vertebral arteries; mesenteric arteries or aorta. Invasive PADs treatment comprised endarterectomy, bypass surgery, percutaneous transluminal angioplasty, stenting or amputation; non-invasive treatment consisted of medication and participation in exercise programs. Primary endpoint was (coronary) target vessel failure: composite of cardiac mortality, target vessel-related myocardial infarction, or clinically indicated target vessel revascularization. Of 461 PCI patients with PADs, information on PADs treatment was available in 357 (77.4%) patients; 249 (69.7%) were treated invasively and 108 (30.3%) non-invasively. Baseline and PCI procedural characteristics showed no between-group difference. Invasiveness of PADs treatment was not associated with adverse event risks, including target vessel failure (20.5% vs. 16.0%; HR: 1.30, 95%-CI 0.75-2.26, p = 0.35), major adverse cardiac events (23.3% vs. 20.4%; HR: 1.16, 95%-CI 0.71-1.90, p = 0.55), and all-cause mortality (12.1% vs. 8.3%; HR: 1.48, 95%-CI 0.70-3.13, p = 0.30). In PADs patients participating in PCI trials, we found no significant relation between the invasiveness of previous PADs treatment and 3-year outcome after PCI. Consequently, high-risk PCI patients can be identified by consulting medical records, searching for PADs, irrespective of the invasiveness of PADs treatment.

Exploring Patterns of COPD Exacerbations and Comorbid Flare-Ups.

Background: Comorbidities are known to complicate disease management in patients with Chronic Obstructive Pulmonary Disease (COPD). This is partly due to lack of insight into the interplay of acute exacerbations of COPD (AECOPD) and comorbid flare-ups. This study aimed to explore patterns of AECOPDs and comorbid flare-ups. Methods: Data of increased symptoms were extracted from a 12-month daily symptom follow-up database including patients with COPD and comorbidities (chronic heart failure (CHF), anxiety, depression) and transformed to visualizations of AECOPDs and comorbid flare-up patterns over time. Patterns were subsequently categorized using an inductive approach, based on both predominance (ie, which occurs most often) of AECOPDs or comorbid flare-ups, and their simultaneous (ie, simultaneous start in ≥ 50%) occurrence. Results: We included 48 COPD patients (68 ± 9 years; comorbid CHF: 52%, anxiety: 40%, depression: 38%). In 25 patients with AECOPDs and CHF flare-ups, the following patterns were identified: AECOPDs predominant (n = 14), CHF flare-ups predominant (n = 5), AECOPDs nor CHF flare-ups predominant (n = 6). Of the 24 patients with AECOPDs and anxiety and/or depression flare-ups, anxiety and depression flare-ups occurred simultaneously in 15 patients. In 9 of these 24 patients, anxiety or depression flare-ups were observed independently from each other. In 31 of the included 48 patients, AECOPDs and comorbid flare-ups occurred mostly simultaneously. Conclusion: Patients with COPD and common comorbidities show a variety of patterns of AECOPDs and comorbid flare-ups. Some patients, however, show repetitive patterns that could potentially be used to improve personalized disease management, if recognized.

Is a preoperative multidisciplinary team meeting (cost)effective to improve outcome for high-risk adult patients undergoing noncardiac surgery: the PREPARATION study-a multicenter stepped-wedge cluster randomized trial.

BACKGROUND: As a result of increased life expectancy and improved care for patients suffering from chronic disease, the number of patients with multimorbidity requiring surgical intervention is increasing. For complex surgical patients, it is essential to balance the potential benefits of surgical treatment against the risk of permanent loss of functional capacity and quality of life due to complications. European and US guidelines on perioperative care recommend preoperative multidisciplinary team (MDT) discussions for high-risk noncardiac surgical patients. However, the evidence underlying benefits from preoperative MDT meetings with all relevant perioperative specialties present is limited. The current study aims to investigate the effect of implementation of preoperative MDT discussions for high-risk patients undergoing noncardiac surgery on serious adverse events. METHODS/DESIGN: PREPARATION is a stepped-wedge cluster randomized trial in 14 Dutch hospitals without currently established preoperative MDT meeting. The intervention, preoperative MDT meetings, will be implemented sequentially with seven blocks of 2 hospitals switching from control (preoperative screening as usual) to the intervention every 3 months. Each hospital will be randomized to one of seven blocks. We aim to include 1200 patients. The primary outcome is the incidence of serious adverse events at 6 months. Secondary outcomes include (cost)effectiveness, functional outcome, and quality of life for up to 12 months. DISCUSSION: PREPARATION is the first study to assess the effectiveness of a preoperative MDT meeting for high-risk noncardiac surgical patients in the presence of an anesthesiologist. If the results suggest that preoperative MDT discussions for high-risk patients are (cost)-effective, the current study facilitates implementation of preoperative MDT meetings in clinical practice. TRIAL REGISTRATION: ClinicalTrials.gov NCT05703230. Registered on 11/09/2022.

Impact of premature coronary artery disease on adverse event risk following first percutaneous coronary intervention.

Objectives: We assessed differences in risk profile and 3-year outcome between patients undergoing percutaneous coronary intervention (PCI) for premature and non-premature coronary artery disease (CAD). Background: The prevalence of CAD increases with age, yet some individuals develop obstructive CAD at younger age. Methods: Among participants in four randomized all-comers PCI trials, without previous coronary revascularization or myocardial infarction (MI), we compared patients with premature (men <50 years; women <55 years) and non-premature CAD. Various clinical endpoints were assessed, including multivariate analyses. Results: Of 6,171 patients, 887 (14.4%) suffered from premature CAD. These patients had fewer risk factors than patients with non-premature CAD, but were more often smokers (60.7% vs. 26.4%) and overweight (76.2% vs. 69.8%). In addition, premature CAD patients presented more often with ST-segment elevation MI and underwent less often treatment of multiple vessels, and calcified or bifurcated lesions. Furthermore, premature CAD patients had a lower all-cause mortality risk (adj.HR: 0.23, 95%-CI: 0.10-0.52; p < 0.001), but target vessel revascularization (adj.HR: 1.63, 95%-CI: 1.18-2.26; p = 0.003) and definite stent thrombosis risks (adj.HR: 2.24, 95%-CI: 1.06-4.72; p = 0.034) were higher. MACE rates showed no statistically significant difference (6.6% vs. 9.4%; adj.HR: 0.86, 95%-CI: 0.65-1.16; p = 0.33). Conclusions: About one out of seven PCI patients was treated for premature CAD. These patients had less complex risk profiles than patients with non-premature CAD; yet, their risk of repeated revascularization and stent thrombosis was higher. As lifetime event risk of patients with premature CAD is known to be particularly high, further efforts should be made to improve modifiable risk factors such as smoking and overweight. TWENTE trials: (TWENTE I, clinicaltrials.gov: NCT01066650), DUTCH PEERS (TWENTE II, NCT01331707), BIO-RESORT (TWENTE III, NCT01674803), and BIONYX (TWENTE IV, NCT02508714).

Outcome of percutaneous coronary intervention using ultrathin-strut biodegradable polymer sirolimus-eluting versus thin-strut durable polymer zotarolimus-eluting stents in patients with comorbid peripheral arterial disease: a post-hoc analysis from two randomized trials.

Background: In patients with peripheral arterial disease (PADs), who underwent percutaneous coronary intervention (PCI), little is known about the potential impact of using different new-generation drug-eluting stents (DES) on outcome. In PCI all-comers, the results of most between-stent comparisons-stratified by strut thickness-suggested some advantage of coronary stents with ultrathin-struts. The current post-hoc analysis aimed to assess outcomes of PCI with ultrathin-strut biodegradable polymer sirolimus-eluting stents (BP-SES) vs. thin-strut durable polymer zotarolimus-eluting stents (DP-ZES) in patients with PADs. Methods: We pooled 3-year patient-level data from two large-scale randomized all-comer trials to compare Orsiro ultrathin-strut BP-SES vs. Resolute-type thin-strut DP-ZES in trial participants with concomitant PADs. BIO-RESORT (December 2012 to August 2015) and BIONYX (October 2015 to December 2016) included all-comer patients who were aged 18 years or older, capable of providing informed consent, and required a PCI. The trials had web-based randomization, with block sizes of 4 and 8, performed in a 1:1:1 or 1:1 fashion. Assessors, research staff, and patients were blinded to the type of stent used. We assessed the composite main clinical endpoint target vessel failure [TVF: cardiac death, target vessel related myocardial infarction (MI), or clinically indicated target vessel revascularization (TVR)], its components, and stent thrombosis. Results: Of 4,830 trial participants, 360 had PADs: 177 (49.2%) were treated with BP-SES and 183 (50.8%) with DP-ZES. Baseline characteristics were similar. For BP-SES, the 3-year TVF rate was 11.0% and for DP-ZES 17.9% [hazard ratio (HR): 0.59, 95% CI: 0.33-1.04; P=0.07]. For BP-SES, the TVR rate was lower than for DP-ZES (4.1% vs. 11.0%; HR: 0.36, 95% CI: 0.15-0.86; P=0.016), but this did not translate into between-group differences in cardiac death or MI. In small vessels (<2.75 mm), the TVR rate was also lower in BP-SES (5.6% vs. 13.9%; HR: 0.32, 95% CI: 0.11-0.91; P=0.024). Definite-or-probable stent thrombosis rates were 1.2% and 2.3% (P=0.43). Conclusions: In PCI patients with PADs, the 3-year TVF incidence was numerically lower in the ultrathin-strut BP-SES vs. the thin-strut DP-ZES group. Furthermore, TVR risk was significantly lower in ultrathin-strut BP-SES, mainly driven by a lower TVR rate in small vessels. Trial Registration: BIO-RESORT trial: clinicaltrials.gov (NCT01674803); BIONYX trial: clinicaltrials.gov (NCT02508714).

First myocardial infarction in patients with premature coronary artery disease: insights into patient characteristics and outcome after treatment with contemporary stents.

AIMS: Patients with premature coronary artery disease (CAD) have a higher incidence of myocardial infarction (MI) than patients with non-premature CAD. The aim of the present study is to asess differences in clinical outcome after a first acute MI, percutaneously treated with new-generation drug-eluting stents between patients with premature and non-premature CAD. METHODS AND RESULTS: We pooled and analysed the characteristics and clinical outcome of all patients with a first MI (and no previous coronary revascularization) at time of enrolment, in four large-scale drug-eluting stent trials. Coronary artery disease was classified premature in men aged <50 and women <55 years. Myocardial infarction patients with premature and non-premature CAD were compared. The main endpoint was major adverse cardiac events (MACE): all-cause mortality, any MI, emergent coronary artery bypass surgery, or clinically indicated target lesion revascularization. Of 3323 patients with a first MI, 582 (17.5%) had premature CAD. These patients had lower risk profiles and underwent less complex interventional procedures than patients with non-premature CAD. At 30-day follow-up, the rates of MACE [hazard ratio (HR): 0.22, 95% confidence interval (CI): 0.07-0.71; P = 0.005), MI (HR: 0.22, 95% CI: 0.05-0.89; P = 0.020), and target vessel failure (HR: 0.30, 95% CI: 0.11-0.82; P = 0.012) were lower in patients with premature CAD. At 1 year, premature CAD was independently associated with lower rates of MACE (adjusted HR: 0.50, 95% CI: 0.26-0.96; P = 0.037) and all-cause mortality (adjusted HR: 0.24, 95% CI: 0.06-0.98; P = 0.046). At 2 years, premature CAD was independently associated with lower mortality (adjusted HR: 0.16, 95% CI: 0.05-0.50; P = 0.002). CONCLUSIONS: First MI patients with premature CAD, treated with contemporary stents, showed lower rates of MACE and all-cause mortality than patients with non-premature CAD, which is most likely related to differences in cardiovascular risk profile. TWENTE trials: TWENTE I, clinicaltrials.gov: NCT01066650), DUTCH PEERS (TWENTE II, NCT01331707), BIO-RESORT (TWENTE III, NCT01674803), and BIONYX (TWENTE IV, NCT02508714).

Artificial intelligence in systematic reviews: promising when appropriately used.

BACKGROUND: Systematic reviews provide a structured overview of the available evidence in medical-scientific research. However, due to the increasing medical-scientific research output, it is a time-consuming task to conduct systematic reviews. To accelerate this process, artificial intelligence (AI) can be used in the review process. In this communication paper, we suggest how to conduct a transparent and reliable systematic review using the AI tool 'ASReview' in the title and abstract screening. METHODS: Use of the AI tool consisted of several steps. First, the tool required training of its algorithm with several prelabelled articles prior to screening. Next, using a researcher-in-the-loop algorithm, the AI tool proposed the article with the highest probability of being relevant. The reviewer then decided on relevancy of each article proposed. This process was continued until the stopping criterion was reached. All articles labelled relevant by the reviewer were screened on full text. RESULTS: Considerations to ensure methodological quality when using AI in systematic reviews included: the choice of whether to use AI, the need of both deduplication and checking for inter-reviewer agreement, how to choose a stopping criterion and the quality of reporting. Using the tool in our review resulted in much time saved: only 23% of the articles were assessed by the reviewer. CONCLUSION: The AI tool is a promising innovation for the current systematic reviewing practice, as long as it is appropriately used and methodological quality can be assured. PROSPERO REGISTRATION NUMBER: CRD42022283952.

Continuous monitoring of patients in and after the acute admission ward to improve clinical pathways: study protocol for a randomized controlled trial (Optimal-AAW).

BACKGROUND: Because of high demand on hospital beds, hospitals seek to reduce patients' length of stay (LOS) while preserving the quality of care. In addition to usual intermittent vital sign monitoring, continuous monitoring might help to assess the patient's risk of deterioration, in order to improve the discharge process and reduce LOS. The primary aim of this monocenter randomized controlled trial is to assess the effect of continuous monitoring in an acute admission ward (AAW) on the percentage of patients who are discharged safely. METHODS: A total of 800 patients admitted to the AAW, for whom it is equivocal whether they can be discharged directly after their AAW stay, will be randomized to either receive usual care without (control group) or with additional continuous monitoring of heart rate, respiratory rate, posture, and activity, using a wearable sensor (sensor group). Continuous monitoring data are provided to healthcare professionals and used in the discharge decision. The wearable sensor keeps collecting data for 14 days. After 14 days, all patients fill in a questionnaire to assess healthcare use after discharge and, if applicable, their experience with the wearable sensor. The primary outcome is the difference in the percentage of patients who are safely discharged home directly from the AAW between the control and sensor group. Secondary outcomes include hospital LOS, AAW LOS, intensive care unit (ICU) admissions, Rapid Response Team calls, and unplanned readmissions within 30 days. Furthermore, facilitators and barriers for implementing continuous monitoring in the AAW and at home will be investigated. DISCUSSION: Clinical effects of continuous monitoring have already been investigated in specific patient populations for multiple purposes, e.g., in reducing the number of ICU admissions. However, to our knowledge, this is the first Randomized Controlled Trial to investigate effects of continuous monitoring in a broad patient population in the AAW. TRIAL REGISTRATION: https://clinicaltrials.gov/ct2/show/NCT05181111 . Registered on 6 January 2022. Start of recruitment: 7 December 2021.

Health Economic Research Assessing the Value of Early Detection of Cardiovascular Disease: A Systematic Review.

INTRODUCTION: Cardiovascular disease (CVD) is the most prominent cause of death worldwide and has a major impact on healthcare budgets. While early detection strategies may reduce the overall CVD burden through earlier treatment, it is unclear which strategies are (most) efficient. AIM: This systematic review reports on the cost effectiveness of recent early detection strategies for CVD in adult populations at risk. METHODS: PubMed and Scopus were searched to identify scientific articles published between January 2016 and May 2022. The first reviewer screened all articles, a second reviewer independently assessed a random 10% sample of the articles for validation. Discrepancies were solved through discussion, involving a third reviewer if necessary. All costs were converted to 2021 euros. Reporting quality of all studies was assessed using the CHEERS 2022 checklist. RESULTS: In total, 49 out of 5552 articles were included for data extraction and assessment of reporting quality, reporting on 48 unique early detection strategies. Early detection of atrial fibrillation in asymptomatic patients was most frequently studied (n = 15) followed by abdominal aortic aneurysm (n = 8), hypertension (n = 7) and predicted 10-year CVD risk (n = 5). Overall, 43 strategies (87.8%) were reported as cost effective and 11 (22.5%) CVD-related strategies reported cost reductions. Reporting quality ranged between 25 and 86%. CONCLUSIONS: Current evidence suggests that early CVD detection strategies are predominantly cost effective and may reduce CVD-related costs compared with no early detection. However, the lack of standardisation complicates the comparison of cost-effectiveness outcomes between studies. Real-world cost effectiveness of early CVD detection strategies will depend on the target country and local context. REGISTRATION OF SYSTEMATIC REVIEW: CRD42022321585 in International Prospective Registry of Ongoing Systematic Reviews (PROSPERO) submitted at 10 May 2022.

Detecting Patient Deterioration Early Using Continuous Heart rate and Respiratory rate Measurements in Hospitalized COVID-19 Patients.

BACKGROUND: Presenting symptoms of COVID-19 patients are unusual compared with many other illnesses. Blood pressure, heart rate, and respiratory rate may stay within acceptable ranges as the disease progresses. Consequently, intermittent monitoring does not detect deterioration as it is happening. We investigated whether continuously monitoring heart rate and respiratory rate enables earlier detection of deterioration compared with intermittent monitoring, or introduces any risks. METHODS: When available, patients admitted to a COVID-19 ward received a wireless wearable sensor which continuously measured heart rate and respiratory rate. Two intensive care unit (ICU) physicians independently assessed sensor data, indicating when an intervention might be necessary (alarms). A third ICU physician independently extracted clinical events from the electronic medical record (EMR events). The primary outcome was the number of true alarms. Secondary outcomes included the time difference between true alarms and EMR events, interrater agreement for the alarms, and severity of EMR events that were not detected. RESULTS: In clinical practice, 48 (EMR) events occurred. None of the 4 ICU admissions were detected with the sensor. Of the 62 sensor events, 13 were true alarms (also EMR events). Of these, two were related to rapid response team calls. The true alarms were detected 39 min (SD = 113) before EMR events, on average. Interrater agreement was 10%. Severity of the 38 non-detected events was similar to the severity of 10 detected events. CONCLUSION: Continuously monitoring heart rate and respiratory rate does not reliably detect deterioration in COVID-19 patients when assessed by ICU physicians.

Physical and mental fatigue in post-COVID syndrome and their associations over time: A small-sample ESM-study to explore fatigue, quality of sleep and behaviours.

OBJECTIVE: Post-COVID syndrome leaves millions of people with severe fatigue, yet little is known about its nature in daily life. In this exploratory study, momentary associations between physical and mental fatigue, quality of sleep and behaviours over two weeks in patients with post-COVID syndrome were assessed. METHOD: Data on fatigue levels, quality of sleep and behaviours was collected for 14 consecutive days using the experience sampling method in ten ex-hospitalised patients with post-COVID syndrome. RESULTS: Multilevel linear regression modelling showed strong associations between physical and mental fatigue (ß = 0.61, p ≤0.001), significant both between and within individuals. Sleeping more hours at night was associated with less physical and mental fatigue the following day (ß = -0.35, p = .001; ß = -0.27, p = .008). Strenuous relaxation (B = 0.45, p ≤0.001; B = 0.28, p = .004) and social contacts (B = -0.33, p = .003; B = -0.22, p = .02) were associated with physical and mental fatigue at the same measurement point. Performing household chores decreased physical and mental fatigue (B = -0.29, p = .02; B = -0.30, p = .006) two hours later on the same day, whereas eating and drinking increased physical fatigue (B = 0.20, p = .05) two hours later on the same day. CONCLUSION: Physical fatigue and mental fatigue were strongly associated and revealed fluctuations in fatigue levels between individuals, which might suggest potentially different post-COVID subgroups. Indications for potential risk and beneficial behaviours for fatigue were found.

Risk of bleeding after percutaneous coronary intervention and its impact on further adverse events in clinical trial participants with comorbid peripheral arterial disease.

BACKGROUND: Both patients with obstructive coronary artery disease (CAD) and patients with peripheral arterial disease (PADs) have an increased bleeding risk. Information is scarce on bleeding in CAD patients, treated with percutaneous coronary intervention (PCI), who have comorbid PADs. We assessed whether PCI patients with PADs have a higher bleeding risk than PCI patients without PADs. Furthermore, in PCI patients with PADs we evaluated the extent by which bleeding increased the risk of further adverse events. METHODS: Three-year pooled patient-level data of two randomized PCI trials (BIO-RESORT, BIONYX) with drug-eluting stents were analyzed to assess mortality and the composite endpoint major adverse cardiac events (MACE: all-cause mortality, any myocardial infarction, emergent coronary artery bypass surgery, or target lesion revascularization). RESULTS: Among 5989 all-comer patients, followed for 3 years, bleeding occurred in 7.7% (34/440) with comorbid PADs and 5.0% (279/5549) without PADs (HR: 1.59, 95%CI: 1.11-2.23, p = 0.010). Of all PADs patients, those with a bleeding had significantly higher rates of all-cause mortality (HR: 4.70, 95%CI: 2.37-9.33, p < 0.001) and MACE (HR: 2.39, 95%CI: 1.23-4.31, p = 0.003). Furthermore, PADs patients with a bleeding were older (74.4 ± 6.9 vs. 67.4 ± 9.5, p < 0.001). After correction for age and other potential confounders, bleeding remained independently associated with all-cause mortality (adj.HR: 2.97, 95%CI: 1.37-6.43, p = 0.006) while the relation of bleeding with MACE became borderline non-significant (adj.HR: 1.85, 95%CI: 0.97-3.55, p = 0.06). CONCLUSION: PCI patients with PADs had a higher bleeding risk than PCI patients without PADs. In PADs patients, bleeding was associated with all-cause mortality, even after adjustment for potential confounders.

Assessment Tools for Measuring Health Literacy and Digital Health Literacy in a Hospital Setting: A Scoping Review.

Assessment of (digital) health literacy in the hospital can raise staff awareness and facilitate tailored communication, leading to improved health outcomes. Assessment tools should ideally address multiple domains of health literacy, fit to the complex hospital context and have a short administration time, to enable routine assessment. This review aims to create an overview of tools for measuring (digital) health literacy in hospitals. A search in Scopus, PubMed, WoS and CINAHL, following PRISMA guidelines, generated 7252 hits; 251 studies were included in which 44 assessment tools were used. Most tools (57%) were self-reported and 27% reported an administration time of <5 min. Almost all tools addressed the domain 'understanding' (98%), followed by 'access' (52%), 'apply' (50%), 'appraise' (32%), 'numeracy' (18%), and 'digital' (18%). Only four tools were frequently used: the Newest Vital Sign (NVS), the Short Test of Functional Health Literacy for Adults ((S)TOFHLA), the Brief Health Literacy Screener (BHLS), and the Health Literacy Questionnaire (HLQ). While the NVS and BHLS have a low administration time, they cover only two domains. HLQ covers the most domains: access, understanding, appraise, and apply. None of these four most frequently used tools measured digital skills. This review can guide health professionals in choosing an instrument that is feasible in their daily practice, and measures the required domains.

Final 5-Year Report of the Randomized BIO-RESORT Trial Comparing 3 Contemporary Drug-Eluting Stents in All-Comers.

Background In a previous trial, higher 5-year mortality was observed following treatment with biodegradable polymer Orsiro sirolimus-eluting stents (SES). We assessed 5-year safety and efficacy of all-comers as well as patients with diabetes treated with SES or Synergy everolimus-eluting stents (EES) versus durable polymer Resolute Integrity zotarolimus-eluting stents (ZES). Methods and Results The randomized BIO-RESORT (Comparison of Biodegradable Polymer and Durable Polymer Drug-Eluting Stents in an All Comers Population) trial enrolled 3514 all-comer patients at 4 Dutch cardiac centers. Patients aged ≥18 years who required percutaneous coronary intervention were eligible. Participants were stratified for diabetes and randomized to treatment with SES, EES, or ZES (1:1:1). The main end point was target vessel failure (cardiac mortality, target vessel myocardial infarction, or target vessel revascularization). Five-year follow-up was available in 3183 of 3514 (90.6%) patients. The main end point target vessel failure occurred in 142 of 1169 (12.7%) patients treated with SES, 130 of 1172 (11.6%) treated with EES, versus 157 of 1173 (14.1%) treated with ZES (hazard ratio [HR], 0.89 [95% CI, 0.71-1.12], Plog-rank=0.31; and HR, 0.82 [95% CI, 0.65-1.04], Plog-rank=0.10, respectively). Individual components of target vessel failure showed no significant between-stent difference. Very late definite stent thrombosis rates were low and similar (SES, 1.1%; EES, 0.6%; ZES, 0.9%). In patients with diabetes, target vessel failure did not differ significantly between stent-groups (SES, 19.8%; EES, 19.2%; versus ZES, 21.1% [Plog-rank=0.69 and Plog-rank=0.63]). Conclusions Orsiro SES, Synergy EES, and Resolute Integrity ZES showed similar 5-year outcomes of safety and efficacy, including mortality. A prespecified stent comparison in patients with diabetes also revealed no significant differences in 5-year clinical outcomes. Registration URL: https://www.clinicaltrials.gov; Unique identifier: NCT01674803.

"It Really Is an Elusive Illness"-Post-COVID-19 Illness Perceptions and Recovery Strategies: A Thematic Analysis.

A substantial number of patients report persisting symptoms after a COVID-19 infection: so-called post-COVID-19 syndrome. There is limited research on patients' perspectives on post-COVID-19 symptoms and ways to recover. This qualitative study explored the illness perceptions and recovery strategies of patients who had been hospitalised for COVID-19. Differences between recovered and non-recovered patients were investigated. Semi-structured in-depth interviews were held with 24 participating patients (8 recovered and 16 non-recovered) 7 to 12 months after hospital discharge. Data were interpreted using reflexive thematic analysis. Four overarching themes were identified: (I) symptoms after hospital discharge; (II) impact of COVID-19 on daily life and self-identity; (III) uncertainty about COVID-19; and (IV) dealing with COVID-19. Formerly hospitalised post-COVID-19 patients seem to have difficulties with making sense of their illness and gaining control over their recovery. The majority of non-recovered participants continue to suffer mostly from weakness or fatigue, dyspnoea and cognitive dysfunction. No notable differences in illness beliefs were observed between recovered and non-recovered participants.