@Article{info:doi/10.2196/68158, author="Yuenyongchaiwat, Kornanong and Harnmanop, Somrudee and Mahawong, Lucksanaporn and Ruangphet, Nattapoomin and Jeangubon, Kannika and Nenmanee, Chaopraya and Kulchanarat, Chitima and Satdhabudha, Opas", title="Beneficial Effects of the Novel Digital Incentive Spirometer Device and Incentive Spirometer in Patients Undergoing Open-Heart Surgery: Randomized Controlled Trial", journal="JMIR Rehabil Assist Technol", year="2025", month="May", day="6", volume="12", pages="e68158", keywords="digital incentive spirometer device", keywords="flow-oriented incentive spirometer", keywords="open-heart surgery", keywords="randomized controlled trial", keywords="respiratory function", abstract="Background: The number of patients undergoing open-heart surgery (OHS) is persistently increasing. Additionally, postoperative pulmonary complications have been reported after OHS, and an incentive spirometer has been suggested to prevent postoperative pulmonary complications. However, no commercial incentive spirometer provides the precise inhalation volume. We developed a digital incentive spirometer (DIS) that displays the relevant data. Objective: In this study, we aimed to explore the beneficial effects of a DIS on respiratory function in patients who underwent OHS. Methods: A randomized controlled trial was designed with 32 patients scheduled for OHS: 16 individuals each were assigned to the DIS and the flow-oriented incentive spirometer (ie, Triflow incentive spirometer) groups, respectively. The patients were requested to use the DIS and Triflow incentive spirometer 15 times/set, two sets/day, from day 1 to 5 postextubation. All participants underwent lung function and respiratory muscle strength assessments prior to OHS and on day 5 postextubation postoperatively. For comparison between and within the groups, we performed an intention-to-treat analysis with a two-way mixed analysis of variance. Results: In both the DIS and Triflow incentive spirometer groups, pulmonary function parameters and maximal respiratory pressure were markedly reduced on day 5 postextubation when compared with those prior to OHS (P<.05). There were no significant differences in pulmonary function or respiratory muscle strength between the two groups (P>.05). Conclusions: Pulmonary function and respiratory muscle strength did not differ significantly between the DIS and Triflow incentive spirometer groups among patients who underwent OHS. Trial Registration: The Thai Clinical Trails Registration TCTR20230922001; https://tinyurl.com/3mn7ck62 ", doi="10.2196/68158", url="https://rehab.jmir.org/2025/1/e68158" } @Article{info:doi/10.2196/70587, author="Wang, Jun and Zhu, Jiajun and Li, Hui and Wu, Shili and Li, Siyang and Yao, Zhuoya and Zhu, Tongjian and Tang, Bi and Tang, Shengxing and Liu, Jinjun", title="Multimodal Visualization and Explainable Machine Learning--Driven Markers Enable Early Identification and Prognosis Prediction for Symptomatic Aortic Stenosis and Heart Failure With Preserved Ejection Fraction After Transcatheter Aortic Valve Replacement: Multicenter Cohort Study", journal="J Med Internet Res", year="2025", month="May", day="1", volume="27", pages="e70587", keywords="machine learning", keywords="interpretable models", keywords="heart failure with preserved ejection fraction", keywords="symptomatic aortic stenosis", keywords="transcatheter aortic valve replacement", keywords="major adverse cardiovascular and cerebrovascular events.", abstract="Background: Currently, there is a paucity of literature addressing personalized risk stratification using multimodal data in patients with symptomatic aortic stenosis and heart failure with preserved ejection fraction (HFpEF) following transcatheter aortic valve replacement (TAVR). Objective: This study aimed to enhance the performance of risk assessment models in this patient population by developing a predictive model for adverse outcomes using various machine learning (ML) techniques. Methods: This multicenter cohort study included 326 patients diagnosed with severe AS and HFpEF who underwent TAVR between January 2017 and December 2023. Patients were allocated to training (n=195) and independent validation (n=131) sets based on hospital affiliation. A dual-phase feature selection process, combining least absolute shrinkage and selection operator logistic regression and the Boruta algorithm, was used to identify relevant variables from the multimodal dataset. A total of 5 ML model-decision trees, K-nearest neighbors, random forest, support vector machine, and extreme gradient boosting were used to construct a visualization and explainable predictive framework to elucidate model decision-making processes. Results: The primary features identified included age, N-terminal pro-brain natriuretic peptide, fasting blood glucose, triglyceride/high-density lipoprotein cholesterol ratio, triglyceride glucose index, triglyceride glucose-BMI index, atherogenic index of plasma index, and Apolipoprotein B. Among the 5 models, the support vector machine demonstrated the best predictive performance for major adverse cardiovascular and cerebrovascular events in patients with severe AS and HFpEF following TAVR, achieving an area under the curve of 0.756 (95\% CI 0.631-0.881) in the independent validation set. The model exhibited good calibration and robust predictive power in both training and validation sets and demonstrated the highest net benefit in decision curve analysis compared to other models. To extract significant variables influencing the algorithm and ensure model appropriateness, we interpreted cohort and personalized model predictions using Shapley Additive Explanations values. Conclusions: Our ML-based multimodal model, incorporating 8 readily accessible predictors, demonstrated robust predictive capability for 12 months of major adverse cardiovascular and cerebrovascular events risk. This model can be used to identify high-risk individuals with AS and HFpEF following TAVR, potentially aiding in risk stratification and personalized treatment strategies. ", doi="10.2196/70587", url="https://www.jmir.org/2025/1/e70587", url="http://www.ncbi.nlm.nih.gov/pubmed/40310672" } @Article{info:doi/10.2196/64586, author="Gong, Chan-Juan and Zhou, Xiao-Kai and Zhang, Zhen-Feng and Fang, Yin", title="Impact of Preventive Intravenous Amiodarone on Reperfusion Ventricular Fibrillation in Patients With Left Ventricular Hypertrophy Undergoing Open-Heart Surgery: Randomized Controlled Clinical Trial", journal="JMIR Form Res", year="2025", month="Jan", day="13", volume="9", pages="e64586", keywords="amiodarone", keywords="left ventricular hypertrophy", keywords="reperfusion ventricular fibrillation", keywords="open-heart surgery", keywords="randomized controlled trial", keywords="RCT", keywords="clinical trial", keywords="ventricular fibrillation", keywords="vicious arrhythmia", keywords="aortic cross-clamp", keywords="surgery", keywords="effectiveness", keywords="defibrillation", abstract="Background: Ventricular fibrillation (VF) is a vicious arrhythmia usually generated after removal of the aortic cross-clamp (ACC) in patients undergoing open-heart surgery, which could damage cardiomyocytes, especially in patients with left ventricular hypertrophy (LVH). Amiodarone has the prominent properties of converting VF and restoring sinus rhythm. However, few studies concentrated on the effect of amiodarone before ACC release on reducing VF in patients with LVH. Objective: The study was designed to explore the effectiveness of prophylactic intravenous amiodarone in reducing VF after the release of the ACC in patients with LVH. Methods: A total of 54 patients with LVH scheduled for open-heart surgery were enrolled and randomly divided (1:1) into 2 groups---group A (amiodarone group) and group P (placebo-controlled group). Thirty minutes before removal of the ACC, the trial drugs were administered intravenously. In group A, 150 mg of amiodarone was pumped in 15 minutes. In group P, the same volume of normal saline was pumped in 15 minutes. The primary outcome was the incidence of VF 10 minutes after removal of the ACC. Results: The incidence of VF was lower in group A than in group P (30\% vs 70\%, P=.003). The duration of VF, the number of defibrillations, and the defibrillation energy were also lower in group A than in group P (P<.001, P=.002, and P=.002, respectively). After the end of cardiopulmonary bypass, the heart rate and mean arterial pressure were lower in group A, and the mean pulmonary arterial pressure and the dose of vasoactive drugs were higher than those in group P (P<.001, P<.001, P=.04, and P=.02, respectively). However, there were no significant differences in the use of vasoactive-inotropic agents and hemodynamic status between the 2 groups before the end of surgery. Conclusions: In patients with LVH who undergo open-heart surgery, amiodarone can be safely used to reduce the incidence of VF, the duration of VF, the frequency of defibrillation, and the energy of defibrillation after ACC removal. Trial Registration: Chinese Clinical Trial Registry ChiCTR2000035057; https://www.chictr.org.cn/showprojEN.html?proj=57145 ", doi="10.2196/64586", url="https://formative.jmir.org/2025/1/e64586" } @Article{info:doi/10.2196/55996, author="Peng, Yanbin and Wei, Xuqiang and Sun, Linxi and Wang, Ke and Zhou, Jia", title="Electroacupuncture and Transcutaneous Electrical Acupoint Stimulation for Perioperative Neurocognitive Disorder in Older Patients Undergoing Cardiac Surgery: Protocol for Systematic Review and Meta-Analysis", journal="JMIR Res Protoc", year="2024", month="Aug", day="29", volume="13", pages="e55996", keywords="perioperative neurocognitive disorder", keywords="cardiac surgery", keywords="elderly patients", keywords="systematic review", keywords="meta-analysis", abstract="Background: Perioperative neurocognitive disorder (PND) is a critical concern for older patients undergoing cardiac surgery, impacting cognitive function and quality of life. Electroacupuncture and transcutaneous electrical acupoint stimulation (TEAS) hold promise for mitigating PND. This protocol outlines a systematic review and meta-analysis to thoroughly assess the efficacy of electroacupuncture and TEAS in older patients undergoing cardiac surgery with PND, providing up-to-date evidence for PND prevention and treatment. Objective: This study aimed to thoroughly assess the efficacy of electroacupuncture and TEAS in older patients undergoing cardiac surgery with PND, providing up-to-date evidence for PND prevention and treatment. Methods: A comprehensive and systematic approach will be used to identify eligible studies from a diverse range of electronic databases, including 9 major sources such as PubMed (NLM) and Cochrane (Wiley), as well as 2 clinical trial registration websites. These studies will focus on investigating the effects of electroacupuncture and TEAS on PND in older patients undergoing cardiac surgery. The study selection will adhere to the criteria outlined in the patient, intervention, comparison, outcome, and studies (PICOS) format. Data extraction will be carried out by 2 independent researchers (YP and LS), using established tools to evaluate the risk of bias. The primary outcome will be PND incidence, with secondary outcomes including Mini Mental State Examination scores, neuron-specific enolase, S100$\beta$, interleukin-1$\beta$, interleukin-6, tumor necrosis factor-$\alpha$, time to first flatus, first defecation, bowel sound recovery, and hospitalization duration to be selectively reported. Adverse events linked to acupuncture, such as bleeding, needle site pain, and local reactions, rather than serious adverse events, will also be considered. Meta-analysis will be performed using appropriate statistical methods to assess the overall effect of electroacupuncture and TEAS on PND prevention, treatment, or other relevant outcomes. The Cochrane Collaboration Risk of Bias tool will be used for assessment, and data synthesis will be executed using the RevMan 5.4 software (Cochrane). Results: We plan to summarize the eligible studies through the use of a PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) flowchart. The findings will be showcased in the form of a summary table of evidence. Figures and forest plots will be used to illustrate the outcomes of the meta-analysis. Conclusions: The impacts of electroacupuncture and TEAS interventions on PND in older patients undergoing cardiac surgery have not yet been established. This protocol addresses a critical gap by thoroughly assessing electroacupuncture and TEAS for PND in older patients undergoing cardiac surgery, enhancing understanding of nonpharmacological interventions, and guiding future research and clinical practices in this field. Its strength lies in rigorous methodology, including comprehensive search strategies, independent review processes, and thorough assessments of the risk of bias. Trial Registration: PROSPERO CRD42023411927; https://tinyurl.com/39xdz6jb International Registered Report Identifier (IRRID): PRR1-10.2196/55996 ", doi="10.2196/55996", url="https://www.researchprotocols.org/2024/1/e55996" } @Article{info:doi/10.2196/45973, author="Dong, Tim and Sinha, Shubhra and Zhai, Ben and Fudulu, Daniel and Chan, Jeremy and Narayan, Pradeep and Judge, Andy and Caputo, Massimo and Dimagli, Arnaldo and Benedetto, Umberto and Angelini, D. Gianni", title="Performance Drift in Machine Learning Models for Cardiac Surgery Risk Prediction: Retrospective Analysis", journal="JMIRx Med", year="2024", month="Jun", day="12", volume="5", pages="e45973", keywords="cardiac surgery", keywords="artificial intelligence", keywords="risk prediction", keywords="machine learning", keywords="operative mortality", keywords="data set drift", keywords="performance drift", keywords="national data set", keywords="adult", keywords="data", keywords="cardiac", keywords="surgery", keywords="cardiology", keywords="heart", keywords="risk", keywords="prediction", keywords="United Kingdom", keywords="mortality", keywords="performance", keywords="model", abstract="Background: The Society of Thoracic Surgeons and European System for Cardiac Operative Risk Evaluation (EuroSCORE) II risk scores are the most commonly used risk prediction models for in-hospital mortality after adult cardiac surgery. However, they are prone to miscalibration over time and poor generalization across data sets; thus, their use remains controversial. Despite increased interest, a gap in understanding the effect of data set drift on the performance of machine learning (ML) over time remains a barrier to its wider use in clinical practice. Data set drift occurs when an ML system underperforms because of a mismatch between the data it was developed from and the data on which it is deployed. Objective: In this study, we analyzed the extent of performance drift using models built on a large UK cardiac surgery database. The objectives were to (1) rank and assess the extent of performance drift in cardiac surgery risk ML models over time and (2) investigate any potential influence of data set drift and variable importance drift on performance drift. Methods: We conducted a retrospective analysis of prospectively, routinely gathered data on adult patients undergoing cardiac surgery in the United Kingdom between 2012 and 2019. We temporally split the data 70:30 into a training and validation set and a holdout set. Five novel ML mortality prediction models were developed and assessed, along with EuroSCORE II, for relationships between and within variable importance drift, performance drift, and actual data set drift. Performance was assessed using a consensus metric. Results: A total of 227,087 adults underwent cardiac surgery during the study period, with a mortality rate of 2.76\% (n=6258). There was strong evidence of a decrease in overall performance across all models (P<.0001). Extreme gradient boosting (clinical effectiveness metric [CEM] 0.728, 95\% CI 0.728-0.729) and random forest (CEM 0.727, 95\% CI 0.727-0.728) were the overall best-performing models, both temporally and nontemporally. EuroSCORE II performed the worst across all comparisons. Sharp changes in variable importance and data set drift from October to December 2017, from June to July 2018, and from December 2018 to February 2019 mirrored the effects of performance decrease across models. Conclusions: All models show a decrease in at least 3 of the 5 individual metrics. CEM and variable importance drift detection demonstrate the limitation of logistic regression methods used for cardiac surgery risk prediction and the effects of data set drift. Future work will be required to determine the interplay between ML models and whether ensemble models could improve on their respective performance advantages. ", doi="10.2196/45973", url="https://xmed.jmir.org/2024/1/e45973" } @Article{info:doi/10.2196/47262, author="Dryden, Lindsay and Song, Jacquelin and Valenzano, J. Teresa and Yang, Zhen and Debnath, Meggie and Lin, Rebecca and Topolovec-Vranic, Jane and Mamdani, Muhammad and Antoniou, Tony", title="Evaluation of Machine Learning Approaches for Predicting Warfarin Discharge Dose in Cardiac Surgery Patients: Retrospective Algorithm Development and Validation Study", journal="JMIR Cardio", year="2023", month="Dec", day="6", volume="7", pages="e47262", keywords="algorithm", keywords="anticlotting", keywords="anticoagulant", keywords="anticoagulation", keywords="blood thinner", keywords="cardiac", keywords="cardiology", keywords="develop", keywords="dosage", keywords="international normalized ratio", keywords="machine learning", keywords="medical informatics", keywords="pharmacology", keywords="postoperative", keywords="predict", keywords="prescribe", keywords="prescription", keywords="surgery", keywords="surgical", keywords="validate", keywords="validation", keywords="warfarin administration and dosage", keywords="warfarin", abstract="Background: Warfarin dosing in cardiac surgery patients is complicated by a heightened sensitivity to the drug, predisposing patients to adverse events. Predictive algorithms are therefore needed to guide warfarin dosing in cardiac surgery patients. Objective: This study aimed to develop and validate an algorithm for predicting the warfarin dose needed to attain a therapeutic international normalized ratio (INR) at the time of discharge in cardiac surgery patients. Methods: We abstracted variables influencing warfarin dosage from the records of 1031 encounters initiating warfarin between April 1, 2011, and November 29, 2019, at St Michael's Hospital in Toronto, Ontario, Canada. We compared the performance of penalized linear regression, k-nearest neighbors, random forest regression, gradient boosting, multivariate adaptive regression splines, and an ensemble model combining the predictions of the 5 regression models. We developed and validated separate models for predicting the warfarin dose required for achieving a discharge INR of 2.0-3.0 in patients undergoing all forms of cardiac surgery except mechanical mitral valve replacement and a discharge INR of 2.5-3.5 in patients receiving a mechanical mitral valve replacement. For the former, we selected 80\% of encounters (n=780) who had initiated warfarin during their hospital admission and had achieved a target INR of 2.0-3.0 at the time of discharge as the training cohort. Following 10-fold cross-validation, model accuracy was evaluated in a test cohort comprised solely of cardiac surgery patients. For patients requiring a target INR of 2.5-3.5 (n=165), we used leave-p-out cross-validation (p=3 observations) to estimate model performance. For each approach, we determined the mean absolute error (MAE) and the proportion of predictions within 20\% of the true warfarin dose. We retrospectively evaluated the best-performing algorithm in clinical practice by comparing the proportion of cardiovascular surgery patients discharged with a therapeutic INR before (April 2011 and July 2019) and following (September 2021 and May 2, 2022) its implementation in routine care. Results: Random forest regression was the best-performing model for patients with a target INR of 2.0-3.0, an MAE of 1.13 mg, and 39.5\% of predictions of falling within 20\% of the actual therapeutic discharge dose. For patients with a target INR of 2.5-3.5, the ensemble model performed best, with an MAE of 1.11 mg and 43.6\% of predictions being within 20\% of the actual therapeutic discharge dose. The proportion of cardiovascular surgery patients discharged with a therapeutic INR before and following implementation of these algorithms in clinical practice was 47.5\% (305/641) and 61.1\% (11/18), respectively. Conclusions: Machine learning algorithms based on routinely available clinical data can help guide initial warfarin dosing in cardiac surgery patients and optimize the postsurgical anticoagulation of these patients. ", doi="10.2196/47262", url="https://cardio.jmir.org/2023/1/e47262", url="http://www.ncbi.nlm.nih.gov/pubmed/38055310" } @Article{info:doi/10.2196/29473, author="Aardoom, J. Jiska and Hilt, D. Alexander and Woudenberg, Tamar and Chavannes, H. Niels and Atsma, E. Douwe", title="A Preoperative Virtual Reality App for Patients Scheduled for Cardiac Catheterization: Pre--Post Questionnaire Study Examining Feasibility, Usability, and Acceptability", journal="JMIR Cardio", year="2022", month="Feb", day="22", volume="6", number="1", pages="e29473", keywords="virtual reality", keywords="cardiac catheterization", keywords="stress inoculation training", keywords="preoperative anxiety", keywords="acceptability", keywords="feasibility", keywords="presence", keywords="immersive tendencies", keywords="patient education", keywords="mobile phone", abstract="Background: Pre- and postoperative anxiety is a common phenomenon associated with negative postoperative outcomes. Symptoms of posttraumatic stress disorder, such as fear, nightmares, and sleep deprivation, are prevalent in approximately 30\% to 50\% of patients following discharge from intensive care units after cardiac surgery. Preliminary evidence suggests a promising role of virtual reality (VR) in preventing stress-related reactions using stress inoculation training. Such training enables cognitive preparation of individuals for stressful situations, thereby becoming more tolerant and resistant to stress, subsequently reducing the risk of potential negative psychological consequences. This study investigated a preoperative VR app---Pre-View---aimed at better informing and preparing patients for cardiac catheterization. Objective: This study aims to assess the feasibility, usability, and acceptability of Pre-View in patients undergoing cardiac catheterization. Methods: Eligible participants were adults scheduled for elective cardiac catheterization. Pre-View comprised an interactive virtual representation of the whole care process related to cardiac catheterization, from entering the hospital for admission to postprocedural stay and discharge. These processes were represented through 360{\textdegree} videos and interactive photos. Self-report questionnaires were completed at baseline (ie, before catheterization and after undergoing the VR experience) and after cardiac catheterization. Outcome measures included user experience and satisfaction, VR presence and immersive tendencies, and user friendliness. The perceived effectiveness was assessed exploratively. Results: A total of 8 individuals, with a mean age of 67 (SD 7.5) years, participated in this study. Half of them underwent the VR experience at the hospital and the other half at home. Participants reported high levels of presence in the virtual environment (Presence Questionnaire score: mean 129.1, SD 13.4). The usability of Pre-View was well evaluated (System Usability Scale score: mean 89.1, SD 12.0), and patient satisfaction was high (Client Satisfaction Questionnaire score: mean 27.1, SD 3.2). Usability and satisfaction scores were higher for participants who underwent Pre-View at home versus those who underwent Pre-View at the hospital, although the latter group was significantly older; 72.8 versus 61.3, respectively. All participants reported Pre-View to be effective in terms of feeling better informed about the care process of cardiac catheterization. Most participants (7/8, 88\%) reported Pre-View to be effective in terms of feeling better prepared for cardiac catheterization, acknowledging the potential of Pre-View in reducing negative psychological consequences after catheterization. Conclusions: The results provide initial support for the feasibility and acceptability of a preoperative VR app, creating a virtual environment that supports patient education and preparation for upcoming cardiac catheterization. More studies are needed to further investigate the effects of VR as a tool to better prepare patients for medical procedures, its effectiveness in reducing negative patient outcomes (eg, anxiety, stress, and postoperative recovery outcomes), and the generalizability of effects across different settings and patient populations. ", doi="10.2196/29473", url="https://cardio.jmir.org/2022/1/e29473", url="http://www.ncbi.nlm.nih.gov/pubmed/35191839" } @Article{info:doi/10.2196/28098, author="Li, Xuan and Chou, Shin-Yi and Deily, E. Mary and Qian, Mengcen", title="Comparing the Impact of Online Ratings and Report Cards on Patient Choice of Cardiac Surgeon: Large Observational Study", journal="J Med Internet Res", year="2021", month="Oct", day="28", volume="23", number="10", pages="e28098", keywords="online physician reviews", keywords="report cards", keywords="cardiac surgeons", keywords="patient choice", abstract="Background: Patients may use two information sources about a health care provider's quality: online physician reviews, which are written by patients to reflect their subjective experience, and report cards, which are based on objective health outcomes. Objective: The aim of this study was to examine the impact of online ratings on patient choice of cardiac surgeon compared to that of report cards. Methods: We obtained ratings from a leading physician review platform, Vitals; report card scores from Pennsylvania Cardiac Surgery Reports; and information about patients' choices of surgeons from inpatient records on coronary artery bypass graft (CABG) surgeries done in Pennsylvania from 2008 to 2017. We scraped all reviews posted on Vitals for surgeons who performed CABG surgeries in Pennsylvania during our study period. We linked the average overall rating and the most recent report card score at the time of a patient's surgery to the patient's record based on the surgeon's name, focusing on fee-for-service patients to avoid impacts of insurance networks on patient choices. We used random coefficient logit models with surgeon fixed effects to examine the impact of receiving a high online rating and a high report card score on patient choice of surgeon for CABG surgeries. Results: We found that a high online rating had positive and significant effects on patient utility, with limited variation in preferences across individuals, while the impact of a high report card score on patient choice was trivial and insignificant. About 70.13\% of patients considered no information on Vitals better than a low rating; the corresponding figure was 26.66\% for report card scores. The findings were robust to alternative choice set definitions and were not explained by surgeon attrition, referral effect, or admission status. Our results also show that the interaction effect of rating information and a time trend was positive and significant for online ratings, but small and insignificant for report cards. Conclusions: A patient's choice of surgeon is affected by both types of rating information; however, over the past decade, online ratings have become more influential, while the effect of report cards has remained trivial. Our findings call for information provision strategies that incorporate the advantages of both online ratings and report cards. ", doi="10.2196/28098", url="https://www.jmir.org/2021/10/e28098", url="http://www.ncbi.nlm.nih.gov/pubmed/34709192" } @Article{info:doi/10.2196/31212, author="Rebelo, Artur and Ukkat, J{\"o}rg and Klose, Johannes and Ronellenfitsch, Ulrich and Kleeff, J{\"o}rg", title="Surgery With Arterial Resection for Hilar Cholangiocarcinoma: Protocol for a Systematic Review and Meta-analysis", journal="JMIR Res Protoc", year="2021", month="Oct", day="5", volume="10", number="10", pages="e31212", keywords="meta-analysis", keywords="cholangiocarcinoma", keywords="arterial resection", keywords="surgery", keywords="vascular resections", keywords="cardiology", keywords="outcomes", keywords="mortality", keywords="morbidity", keywords="perioperative", keywords="cancer", keywords="tumor", keywords="liver", keywords="liver cancer", abstract="Background: In light of recent advances in multimodality treatment, an analysis of vascular resection outcomes in surgery for hilar cholangiocarcinoma is lacking. Objective: The aim of this meta-analysis is to summarize the currently available evidence on outcomes of patients undergoing arterial resection for the treatment of hilar cholangiocarcinoma. Methods: A systematic literature search in the databases PubMed/MEDLINE, Cochrane Library, and CINAHL, and the trial registries ClinicalTrials.gov and the World Health Organization International Clinical Trials Registry Platform will be carried out. Predefined outcomes are mortality (100-day and in-hospital), morbidity (Clavien-Dindo classification, any type of complication), vascular complications (thrombosis or stenosis of the portal vein or hepatic artery, pseudoaneurysms), liver failure, postoperative bleeding, duration of surgery, reoperation rate, length of hospital stay, survival time, actuarial survival (2-, 3-, and 5-year survival), complete/incomplete resection rates, histologic arterial invasion, and lymph node positivity (number of positive lymph nodes and lymph node ratio). Results: Database searches will commence in December 2020. The meta-analysis will be completed by December 2021. Conclusions: Our findings will enable us to present the current evidence on the feasibility, safety, and oncological effectiveness of surgery for hilar cholangiocarcinoma with arterial resection. Our data will support health care professionals and patients in their clinical decision-making. Trial Registration: PROSPERO 223396; https://www.crd.york.ac.uk/prospero/display\_record.php?RecordID=223396 International Registered Report Identifier (IRRID): DERR1-10.2196/31212 ", doi="10.2196/31212", url="https://www.researchprotocols.org/2021/10/e31212", url="http://www.ncbi.nlm.nih.gov/pubmed/34609321" } @Article{info:doi/10.2196/30951, author="Martorella, Geraldine and Hanley, W. Adam and Pickett, M. Scott and Gelinas, C{\'e}line", title="Web- and Mindfulness-Based Intervention to Prevent Chronic Pain After Cardiac Surgery: Protocol for a Pilot Randomized Controlled Trial", journal="JMIR Res Protoc", year="2021", month="Aug", day="30", volume="10", number="8", pages="e30951", keywords="postoperative pain", keywords="cardiac surgery", keywords="chronic pain", keywords="web-based", keywords="mindfulness", keywords="mobile phone", abstract="Background: Cardiac surgery is a frequently performed procedure. However, pain after cardiac surgery may become chronic (lasting >3 months) in adults. Once discharged from the hospital, patients are at greater risk of developing chronic postsurgical pain (CPSP) and of prolonged opioid use, as they need to self-manage their pain. Psychological risk and protective factors such as pain-related catastrophic thoughts and pain acceptance determine their ability to cope and their use of opioids, which is crucial for self-management of pain. Studies on mindfulness-based cognitive therapy (MBCT) have multiplied their potential effects on pain acceptance and catastrophic thoughts. However, web-based MBCT for the prevention of CPSP has not yet been examined. Objective: The aim of this study is to pilot test a 4-week-long web-based MBCT intervention for adults following discharge from the hospital by assessing the acceptability or feasibility of the intervention and examining preliminary effects on pain intensity, pain interference with activities and opioid use, and pain acceptance and catastrophic thoughts in the 6 months following surgery. Methods: A double-blinded pilot randomized controlled trial will be used to assess a web-based MBCT intervention. Patients will be selected according to the following criteria: age ?18 years; first-time elective cardiac surgery via a median sternotomy; worst pain in the past week score ?4/10; ability to understand and complete questionnaires in English; and ability to use an electronic device such as a smartphone, computer, or tablet. After baseline measures, 32 participants will be randomized into two groups: one receiving both the brief, 4-week-long web-based MBCT intervention and usual care (experimental group) and the other receiving only one standardized, web-based educational session with weekly reminders and usual care (attention control group). Peer-reviewed competitive funding was received from Florida State University's Council on Research \& Creativity in January 2021, as well as research ethics approval from Florida State University's institutional review board. Results: Recruitment began in June 2021. Unfortunately, because of the current COVID-19 pandemic, recruitment is not progressing as expected. Recruitment strategies are constantly monitored and updated according to latest data and restrictions surrounding the pandemic. Conclusions: This research is significant because it targets the trajectory of CPSP, a leading cause of disability and opioid misuse. This is the first study to assess MBCT for the prevention of CPSP after cardiac surgery in the recovery phase. This approach is innovative because it promotes self-management of pain through the modulation of individual factors. If successful, the intervention could be expanded to numerous populations at risk of chronic pain. International Registered Report Identifier (IRRID): DERR1-10.2196/30951 ", doi="10.2196/30951", url="https://www.researchprotocols.org/2021/8/e30951", url="http://www.ncbi.nlm.nih.gov/pubmed/34459749" } @Article{info:doi/10.2196/25397, author="Kerr, M. Kim and Elliott, Greg C. and Benza, L. Raymond and Channick, N. Richard and Chin, M. Kelly and Davis, Duane R. and Jain, Sonia and LaCroix, Z. Andrea and Madani, M. Michael and McLaughlin, V. Vallerie and Park, H. Myung and Tapson, F. Victor and Auger, R. William", title="The United States Chronic Thromboembolic Pulmonary Hypertension Registry: Protocol for a Prospective, Longitudinal Study", journal="JMIR Res Protoc", year="2021", month="May", day="25", volume="10", number="5", pages="e25397", keywords="CTEPH", keywords="pulmonary hypertension", keywords="pulmonary embolism", keywords="registry", keywords="surgical", keywords="nonsurgical", keywords="therapy", keywords="treatment", abstract="Background: Chronic thromboembolic pulmonary hypertension (CTEPH) is a rare sequela of acute pulmonary embolism that is treatable when recognized. Awareness of this disease has increased with recent advancements in therapeutic options, but delays in diagnosis remain common, and diagnostic and treatment guidelines are often not followed. Data gathered from international registries have improved our understanding of CTEPH, but these data may not be applicable to the US population owing to differences in demographics and medical practice patterns. Objective: The US CTEPH Registry (US-CTEPH-R) was developed to provide essential information to better understand the demographics, risk factors, evaluation, and treatment of CTEPH in the United States, as well as the short- and long-term outcomes of surgical and nonsurgical therapies in the modern treatment era. Methods: Thirty sites throughout the United States enrolled 750 subjects in this prospective, longitudinal, observational registry of patients newly diagnosed with CTEPH. Enrollment criteria included a mean pulmonary artery pressure ?25 mmHg by right heart catheterization and radiologic confirmation of CTEPH by a multidisciplinary adjudication committee. Following enrollment, subjects were followed biannually until the conclusion of the study. Quality of life surveys were administered at enrollment and biannually, and all other testing was at the discretion of the treating clinician. Details regarding surgical therapy, balloon pulmonary angioplasty, and medical therapy were collected at enrollment and at follow-up, as well as information related to health care utilization and survival. Results: Data from this registry will improve understanding of the demographics, risk factors, and treatment patterns of patients with CTEPH, and the longitudinal impact of therapies on quality of life, health care utilization, and survival. Conclusions: This manuscript details the methodology and design of the first large, prospective, longitudinal registry of patients with CTEPH in the United States. Trial Registration: ClinicalTrials.gov NCT02429284; https://www.clinicaltrials.gov/ct2/show/NCT02429284 International Registered Report Identifier (IRRID): DERR1-10.2196/25397 ", doi="10.2196/25397", url="https://www.researchprotocols.org/2021/5/e25397", url="http://www.ncbi.nlm.nih.gov/pubmed/33848258" } @Article{info:doi/10.2196/22536, author="Likosky, Donald and Yule, J. Steven and Mathis, R. Michael and Dias, D. Roger and Corso, J. Jason and Zhang, Min and Krein, L. Sarah and Caldwell, D. Matthew and Louis, Nathan and Janda, M. Allison and Shah, J. Nirav and Pagani, D. Francis and Stakich-Alpirez, Korana and Manojlovich, M. Milisa", title="Novel Assessments of Technical and Nontechnical Cardiac Surgery Quality: Protocol for a Mixed Methods Study", journal="JMIR Res Protoc", year="2021", month="Jan", day="8", volume="10", number="1", pages="e22536", keywords="cardiac surgery", keywords="quality", keywords="protocol", keywords="study", keywords="coronary artery bypass grafting surgery", keywords="complications", keywords="patient risk", keywords="variation", keywords="intraoperative", keywords="improvement", abstract="Background: Of the 150,000 patients annually undergoing coronary artery bypass grafting, 35\% develop complications that increase mortality 5 fold and expenditure by 50\%. Differences in patient risk and operative approach explain only 2\% of hospital variations in some complications. The intraoperative phase remains understudied as a source of variation, despite its complexity and amenability to improvement. Objective: The objectives of this study are to (1) investigate the relationship between peer assessments of intraoperative technical skills and nontechnical practices with risk-adjusted complication rates and (2) evaluate the feasibility of using computer-based metrics to automate the assessment of important intraoperative technical skills and nontechnical practices. Methods: This multicenter study will use video recording, established peer assessment tools, electronic health record data, registry data, and a high-dimensional computer vision approach to (1) investigate the relationship between peer assessments of surgeon technical skills and variability in risk-adjusted patient adverse events; (2) investigate the relationship between peer assessments of intraoperative team-based nontechnical practices and variability in risk-adjusted patient adverse events; and (3) use quantitative and qualitative methods to explore the feasibility of using objective, data-driven, computer-based assessments to automate the measurement of important intraoperative determinants of risk-adjusted patient adverse events. Results: The project has been funded by the National Heart, Lung and Blood Institute in 2019 (R01HL146619). Preliminary Institutional Review Board review has been completed at the University of Michigan by the Institutional Review Boards of the University of Michigan Medical School. Conclusions: We anticipate that this project will substantially increase our ability to assess determinants of variation in complication rates by specifically studying a surgeon's technical skills and operating room team member nontechnical practices. These findings may provide effective targets for future trials or quality improvement initiatives to enhance the quality and safety of cardiac surgical patient care. International Registered Report Identifier (IRRID): PRR1-10.2196/22536 ", doi="10.2196/22536", url="https://www.researchprotocols.org/2021/1/e22536", url="http://www.ncbi.nlm.nih.gov/pubmed/33416505" } @Article{info:doi/10.2196/17206, author="Michel, Sophie and Piekarski, Florian and Fischer, Jan-Hendrik and Hettler, Vanessa and Adam, Hannah Elisabeth and Holzer, Lars and Lotz, G{\"o}sta and Walther, Thomas and Zacharowski, Kai and Raimann, J{\"u}rgen Florian", title="Hemostatis Analyzer-Supported Hemotherapy Algorithm in Cardiac Surgery: Protocol for a Randomized Controlled Monocentric Trial", journal="JMIR Res Protoc", year="2020", month="Apr", day="21", volume="9", number="4", pages="e17206", keywords="Quantra", keywords="cardiothoracic surgery", keywords="bypass", keywords="coagulopathy", keywords="point of care", keywords="algorithm", keywords="rotational thromboelastometry", keywords="Multiplate", abstract="Background: Point of care devices for performing targeted coagulation substitution in patients who are bleeding have become increasingly important in recent years. New on the market is the Quantra. It is a device that uses sonorheometry, a sonic estimation of elasticity via resonance, which is a novel ultrasound-based technology that measures viscoelastic properties of whole blood. Several studies have already shown the comparability of the Quantra with devices already established on the market, such as the rotational thromboelastometry (ROTEM) device. Objective: In contrast to existing studies, this study is the first prospective interventional study using this new system in a cardiac surgical patient cohort. We will investigate the noninferiority between an already existing coagulation algorithm based on the ROTEM/Multiplate system and a new algorithm based on the Quantra system for the treatment of coagulopathic cardiac surgical patients. Methods: The study is divided into two phases. In an initial observation phase, whole blood samples of 20 patients obtained at three defined time points (prior to surgery, after completion of cardiopulmonary bypass, and on arrival in the intensive care unit) will be analyzed using both the ROTEM/Multiplate and Quantra systems.The obtained threshold values will be used to develop a novel algorithm for hemotherapy. In a second intervention phase, the new algorithm will be tested for noninferiority against an algorithm used routinely for years in our department. Results: The main objective of the examination is the cumulative loss of blood within 24 hours after surgery. Statistical calculations based on the literature and in-house data suggest that the new algorithm is not inferior if the difference in cumulative blood loss is <150 mL/24 hours. Conclusions: Because of the comparability of the Quantra sonorheometry system with the ROTEM measurement methods, the existing hemotherapy treatment algorithm can be adapted to the Quantra device with proof of noninferiority. Trial Registration: ClinicalTrials.gov NCT03902275; https://clinicaltrials.gov/ct2/show/NCT03902275 International Registered Report Identifier (IRRID): DERR1-10.2196/17206 ", doi="10.2196/17206", url="http://www.researchprotocols.org/2020/4/e17206/", url="http://www.ncbi.nlm.nih.gov/pubmed/32314972" } @Article{info:doi/10.2196/16326, author="Biersteker, E. Tom and Boogers, J. Mark and de Lind van Wijngaarden, AF Robert and Groenwold, HH Rolf and Trines, A. Serge and van Alem, P. Anouk and Kirchhof, JHJ Charles and van Hof, Nicolette and Klautz, JM Robert and Schalij, J. Martin and Treskes, W. Roderick", title="Use of Smart Technology for the Early Diagnosis of Complications After Cardiac Surgery: The Box 2.0 Study Protocol", journal="JMIR Res Protoc", year="2020", month="Apr", day="21", volume="9", number="4", pages="e16326", keywords="mHealth", keywords="cardiac surgery", keywords="atrial fibrillation", keywords="postoperative care", keywords="ambulatory electrocardiography", abstract="Background: Atrial fibrillation (AF), sternal wound infection, and cardiac decompensation are complications that can occur after cardiac surgery. Early detection of these complications is clinically relevant, as early treatment is associated with better clinical outcomes. Remote monitoring with the use of a smartphone (mobile health [mHealth]) might improve the early detection of complications after cardiac surgery. Objective: The primary aim of this study is to compare the detection rate of AF diagnosed with an mHealth solution to the detection rate of AF diagnosed with standard care. Secondary objectives include detection of sternal wound infection and cardiac decompensation, as well as assessment of quality of life, patient satisfaction, and cost-effectiveness. Methods: The Box 2.0 is a study with a prospective intervention group and a historical control group for comparison. Patients undergoing cardiac surgery at Leiden University Medical Center are eligible for enrollment. In this study, 365 historical patients will be used as controls and 365 other participants will be asked to receive either The Box 2.0 intervention consisting of seven home measurement devices along with a video consultation 2 weeks after discharge or standard cardiac care for 3 months. Patient information will be analyzed according to the intention-to-treat principle. The Box 2.0 devices include a blood pressure monitor, thermometer, weight scale, step count watch, single-lead electrocardiogram (ECG) device, 12-lead ECG device, and pulse oximeter. Results: The study started in November 2018. The primary outcome of this study is the detection rate of AF in both groups. Quality of life is measured with the five-level EuroQol five-dimension (EQ-5D-5L) questionnaire. Cost-effectiveness is calculated from a society perspective using prices from Dutch costing guidelines and quality of life data from the study. In the historical cohort, 93.9\% (336/358) completed the EQ-5D-5L and patient satisfaction questionnaires 3 months after cardiac surgery. Conclusions: The rationale and design of a study to investigate mHealth devices in postoperative cardiac surgery patients are presented. The first results are expected in September 2020. Trial Registration: ClinicalTrials.gov NCT03690492; http://clinicaltrials.gov/show/NCT03690492 International Registered Report Identifier (IRRID): DERR1-10.2196/16326 ", doi="10.2196/16326", url="http://www.researchprotocols.org/2020/4/e16326/", url="http://www.ncbi.nlm.nih.gov/pubmed/32314974" } @Article{info:doi/10.2196/17131, author="Hilt, D. Alexander and Kaptein, A. Ad and Schalij, J. Martin and van Schaik, Jan", title="Teamwork and Safety Attitudes in Complex Aortic Surgery at a Dutch Hospital: Cross-Sectional Survey Study", journal="JMIR Hum Factors", year="2020", month="Apr", day="8", volume="7", number="2", pages="e17131", keywords="human factors", keywords="organizational culture", keywords="SAQ", keywords="SAQ-NL", keywords="safety assessment", keywords="vascular surgery", abstract="Background: Improving teamwork in surgery is a complex goal and difficult to achieve. Human factors questionnaires, such as the Safety Attitudes Questionnaire (SAQ), can help us understand medical teamwork and may assist in achieving this goal. Objective: This paper aimed to assess local team and safety culture in a cardiovascular surgery setting to understand how purposeful teamwork improvements can be reached. Methods: Two cardiovascular surgical teams performing complex aortic treatments were assessed: an endovascular-treatment team (ETT) and an open-treatment team (OTT). Both teams answered an online version of the SAQ Dutch Edition (SAQ-NL) consisting of 30 questions related to six different domains of safety: teamwork climate, safety climate, job satisfaction, stress recognition, perceptions of management, and working conditions. In addition, one open-ended question was posed to gain more insight into the completed questionnaires. Results: The SAQ-NL was completed by all 23 ETT members and all 13 OTT members. Team composition was comparable for both teams: 57\% and 62\% males, respectively, and 48\% and 54\% physicians, respectively. All participants worked for 10 years or more in health care. SAQ-NL mean scores were comparable between both teams, with important differences found between the physicians and nonphysicians of the ETT. Nonphysicians were less positive about the safety climate, job satisfaction, and working climate domains than were the physicians (P<.05). Additional education on performed procedures, more conjoined team training, as well as a hybrid operating room were suggested by participants as important areas of improvement. Conclusions: Nonphysicians of a local team performing complex endovascular aortic aneurysm surgery perceived safety climate, job satisfaction, and working conditions less positively than did physicians from the same team. Open-ended questions suggested that this is related to a lack of adequate conjoined training, lack of adequate education, and lack of an adequate operating room. With added open-ended questions, the SAQ-NL appears to be an assessment tool that allows for developing strategies that are instrumental in improving quality of care. ", doi="10.2196/17131", url="https://humanfactors.jmir.org/2020/2/e17131", url="http://www.ncbi.nlm.nih.gov/pubmed/32267238" } @Article{info:doi/10.2196/13123, author="Zhu, Zhihui and Zhang, Haibo and Li, Yuehuan and Meng, Xu and Jiao, Yuqing and Qin, Ying and Li, Yan and Han, Jie and Liu, Kun and Liu, Chongyang", title="Establishment of a New Platform for the Management of Patients After Cardiac Surgery: Descriptive Study", journal="JMIR Med Inform", year="2019", month="Apr", day="01", volume="7", number="2", pages="e13123", keywords="follow-up", keywords="cardiac surgery", keywords="telemedicine", abstract="Background: Medical care for the Chinese population has been focused on first-line treatment, but with little follow-up on treated patients. As an important part of clinical work, follow-up evaluations are of great significance for the long-term survival of patients and for clinical and scientific research. However, the overall follow-up rate of discharged patients after surgery has been low for many years because of the limitations of certain follow-up methods and the presence of objective, practical problems. Objective: This study aimed to construct a new two-way interactive telemedicine follow-up platform to improve the collection of clinical data after cardiac surgery and provide reliable and high-quality follow-up services. Methods: Computer and network technologies were employed in the context of ``Internet +'' to develop follow-up databases and software compatible with a mobile network. Postoperative follow-up quality data including the follow-up rate and important postoperative indices were used as standards to evaluate the new follow-up management model after cardiac surgery. Results: This system has been officially operated for more than 5 years. A total of 5347 patients undergoing cardiac surgery have been enrolled, and the total follow-up rate was 90.22\%. In addition, 6349 echocardiographic images, 4717 electrocardiographic images, and 3504 chest radiographic images have been uploaded during follow-up assessments. The international standardized ratio was 20,696 person-times. Conclusions: This new management follow-up platform can be used to effectively collect clinical data, provide technical support for academic research, extend medical services, and provide more help to patients. It is of great significance for managing patients after cardiac surgery. ", doi="10.2196/13123", url="https://medinform.jmir.org/2019/2/e13123/", url="http://www.ncbi.nlm.nih.gov/pubmed/30932865" } @Article{info:doi/10.2196/12008, author="Napa, Sandeep and Moore, Michael and Bardyn, Tania", title="Advancing Cardiac Surgery Case Planning and Case Review Conferences Using Virtual Reality in Medical Libraries: Evaluation of the Usability of Two Virtual Reality Apps", journal="JMIR Hum Factors", year="2019", month="Jan", day="16", volume="6", number="1", pages="e12008", keywords="virtual reality", keywords="cardiac surgery", keywords="usability study", keywords="system usability score", keywords="NASA-Task Load Index", keywords="medical libraries", keywords="case planning", keywords="presurgical planning", abstract="Background: Care providers and surgeons prepare for cardiac surgery using case conferences to review, discuss, and run through the surgical procedure. Surgeons visualize a patient's anatomy to decide the right surgical approach using magnetic resonance imaging and echocardiograms in a presurgical case planning session. Previous studies have shown that surgical errors can be reduced through the effective use of immersive virtual reality (VR) to visualize patient anatomy. However, inconsistent user interfaces, delegation of view control, and insufficient depth information cause user disorientation and interaction difficulties in using VR apps for case planning. Objective: The objective of the study was to evaluate and compare the usability of 2 commercially available VR apps---Bosc (Pyrus Medical systems) and Medical Holodeck (Nooon Web \& IT GmbH)---using the Vive VR headset (HTC Corporation) to evaluate ease of use, physician attitudes toward VR technology, and viability for presurgical case planning. The role of medical libraries in advancing case planning is also explored. Methods: After screening a convenience sample of surgeons, fellows, and residents, ethnographic interviews were conducted to understand physician attitudes and experience with VR. Gaps in current case planning methods were also examined. We ran a usability study, employing a concurrent think-aloud protocol. To evaluate user satisfaction, we used the system usability scale (SUS) and the National Aeronautics and Space Administration-Task Load Index (NASA-TLX). A poststudy questionnaire was used to evaluate the VR experience and explore the role of medical libraries in advancing presurgical case planning. Semistructured interview data were analyzed using content analysis with feedback categorization. Results: Participants were residents, fellows, and surgeons from the University of Washington with a mean age of 41.5 (SD 11.67) years. A total of 8 surgeons participated in the usability study, 3 of whom had prior exposure to VR. Users found Medical Holodeck easier to use than Bosc. Mean adjusted NASA-TLX score for Medical Holodeck was 62.71 (SD 18.25) versus Bosc's 40.87 (SD 13.90). Neither app passed the mean SUS score of 68 for an app to be considered usable, though Medical Holodeck (66.25 [SD 12.87]) scored a higher mean SUS than Bosc (37.19 [SD 22.41]). One user rated the Bosc usable, whereas 3 users rated Medical Holodeck usable. Conclusions: Interviews highlighted the importance of precise anatomical conceptualization in presurgical case planning and teaching, identifying it as the top reason for modifying a surgical procedure. The importance of standardized user interaction features such as labeling is justified. The study also sheds light on the new roles medical librarians can play in curating VR content and promoting interdisciplinary collaboration. ", doi="10.2196/12008", url="http://humanfactors.jmir.org/2019/1/e12008/", url="http://www.ncbi.nlm.nih.gov/pubmed/30664469" }