Representation of obesity in contemporary atrial fibrillation ablation randomized controlled trials.

BACKGROUND: The prevalence and impact of obesity on outcomes of atrial fibrillation (AF) ablation randomized controlled trials (RCTs) have not been well studied. OBJECTIVE: To examine the proportion of participants with obesity enrolled in RCTs of AF ablation and outcomes of ablation when subgroup analysis of participants with obesity were available. METHODS: We systematically searched PubMed and EMBASE for AF ablation RCTs published between January 1, 2015 to May 31, 2022. When body mass index (BMI) data were available, normal distribution was assumed and a z score was used to estimate the proportion of obesity. Results categorized by BMI or body weight status were reviewed. Authors were contacted for additional information. RESULTS: Of 148 eligible RCTs with 30174 participants, 144 (97.30%) RCTs did not report the proportion of participants with obesity, while published information regarding BMI was available in 63.51%. Three trials excluded patients based on BMI. Using reported BMI, we estimated the proportion of participants with obesity varied greatly across these trials, ranging from 5.82%-71.9% (median 38.02%, interquartile 29.64%, 49.10%). Patients with obesity were represented in a greater proportion among trials conducted in North America (50.23%) and Asia (44.72%), compared to others (32.16%), p < .001. Subgroup analysis or analysis adjusting for BMI was reported in only 13 (8.78%) RCTs; four (30.77%) of these suggested that BMI or body weight might negatively affect primary outcomes. CONCLUSION: Obesity is a common comorbidity among AF patients. However, most AF ablation RCTs underreported the proportion of participants with obesity and its impact on the primary outcomes.

Artificial Intelligence, Computational Simulations, and Extended Reality in Cardiovascular Interventions.

Artificial intelligence, computational simulations, and extended reality, among other 21st century computational technologies, are changing the health care system. To collectively highlight the most recent advances and benefits of artificial intelligence, computational simulations, and extended reality in cardiovascular therapies, we coined the abbreviation AISER. The review particularly focuses on the following applications of AISER: 1) preprocedural planning and clinical decision making; 2) virtual clinical trials, and cardiovascular device research, development, and regulatory approval; and 3) education and training of interventional health care professionals and medical technology innovators. We also discuss the obstacles and constraints associated with the application of AISER technologies, as well as the proposed solutions. Interventional health care professionals, computer scientists, biomedical engineers, experts in bioinformatics and visualization, the device industry, ethics committees, and regulatory agencies are expected to streamline the use of AISER technologies in cardiovascular interventions and medicine in general.

Prevalence and Impact of Poorly Controlled Modifiable Risk Factors Among Patients Who Underwent Atrial Fibrillation Ablation.

Managing atrial fibrillation (AF) risk factors (RFs) improves ablation outcomes in obese patients. However, real-world data, including nonobese patients, are limited. This study examined the modifiable RFs of consecutive patients who underwent AF ablation at a tertiary care hospital from 2012 to 2019. The prespecified RFs included body mass index (BMI) ≥30 kg/m2, >5% fluctuation in BMI, obstructive sleep apnea with continuous positive airway pressure noncompliance, uncontrolled hypertension, uncontrolled diabetes, uncontrolled hyperlipidemia, tobacco use, alcohol use higher than the standard recommendation, and a diagnosis-to-ablation time (DAT) >1.5 years. The primary outcome was a composite of arrhythmia recurrence, cardiovascular admissions, and cardiovascular death. In this study, a high prevalence of preablation modifiable RFs was observed. More than 50% of the 724 study patients had uncontrolled hyperlipidemia, a BMI ≥30 mg/m2, a fluctuating BMI >5%, or a delayed DAT. During a median follow-up of 2.6 (interquartile range 1.4 to 4.6) years, 467 patients (64.5%) met the primary outcome. Independent RFs were a fluctuation in BMI >5% (hazard ratio [HR] 1.31, p = 0.008), diabetes with A1c ≥6.5% (HR 1.50, p = 0.014), and uncontrolled hyperlipidemia (HR 1.30, p = 0.005). A total of 264 patients (36.46%) had at least 2 of these predictive RFs, which was associated with a higher incidence of the primary outcome. Delayed DAT over 1.5 years did not alter the ablation outcome. In conclusion, substantial portions of patients who underwent AF ablation have potentially modifiable RFs that were not well controlled. Fluctuating BMI, diabetes with hemoglobin A1c ≥6.5%, and uncontrolled hyperlipidemia portend an increased risk of recurrent arrhythmia, cardiovascular hospitalizations, and mortality after ablation.

Predictive value of interatrial block on electrocardiogram among obese patients undergoing atrial fibrillation ablation.

BACKGROUND: Determine a predictive value of interatrial block (IAB) on atrial fibrillation (AF) ablation outcomes in obese patients. METHODS: Medical records were retrospectively reviewed for 205 consecutive patients with body mass indices (BMI) ≥ 30 kg/m2 who underwent initial AF ablation. Evidence of partial IAB defined as P-wave duration (PWD) ≥ 120 ms and advanced IAB with PWD ≥ 120 ms and biphasic or negative P-wave in inferior leads was examined from sinus electrocardiograms (ECGs) within 1-year pre-ablation. The primary outcome was recurrent atrial arrhythmia after 3-month blanking period post-ablation. RESULTS: The mean BMI was 36.9 ± 5.7 kg/m2. Partial IAB and advanced IAB were observed in 155 (75.61%) and 42 (20.49%) patients, respectively. During the median follow-up of 1.35 (interquartile range 0.74, 2.74) years, 115 (56.1%) patients had recurrent atrial arrhythmias. In multivariable analysis adjusting for age, gender, persistent AF, use of antiarrhythmic drugs (AADs), left atrial volume index (LAVI), partial IAB, and advanced IAB were independent predictors of recurrent arrhythmia with hazard ratio (HR) of 2.80 (95% confidence interval [CI] 1.47-6.05; p = 0.001) and HR 1.79 (95% CI 1.11-2.82; p = 0.017), respectively. The results were similar in a subgroup analysis of patients who had no severe left atrial enlargement and a subgroup analysis of patients who were not on AADs. CONCLUSIONS: IAB is highly prevalent in patients with obesity and AF. Partial IAB, defined as PWD ≥ 120 ms, and advanced IAB with evidence of biphasic P-wave in inferior leads were independently associated with increased risk of recurrent arrhythmia after AF ablation. Its predictive value is independent of other traditional risk factors, LAVI, or use of AADs.

The National Cardiovascular Data Registry Data Quality Program 2020: JACC State-of-the-Art Review.

The National Cardiovascular Data Registry is a group of registries maintained by the American College of Cardiology Foundation. These registries are used by a diverse constituency to improve the quality and outcomes of cardiovascular care, to assess the safety and effectiveness of new therapies, and for research. To achieve these goals, registry data must be complete and reliable. In this article, we review the process of National Cardiovascular Data Registry data collection, assess data completeness and integrity, and report on the current state of the data. Registry data are complete. Accuracy is very good but variable, and there is room for improvement. Knowledge of the quality of data is essential to ensuring its appropriate use.

The Role of Computer Skills in Personal Health Record Adoption Among Patients With Heart Disease: Multidimensional Evaluation of Users Versus Nonusers.

BACKGROUND: In the era of precision medicine, it is critical for health communication efforts to prioritize personal health record (PHR) adoption. OBJECTIVE: The objective of this study was to describe the characteristics of patients with heart disease that choose to adopt a PHR. METHODS: A total of 79 patients with chronic cardiovascular disease participated in this study: 48 PHR users and 31 nonusers. They completed 5 surveys related to their choice to use or not use the PHR: demographics, patient activation, medication adherence, health literacy, and computer self-efficacy (CSE). RESULTS: There was a significant difference between users and nonusers in the sociodemographic measure education (P=.04). There was no significant difference between users and nonusers in other sociodemographic measures: age (P=.20), sex (P=.35), ethnicity (P=.43), race (P=.42), and employment (P=.63). There was a significant difference between PHR users and PHR nonusers in CSE (P=.006). CONCLUSIONS: In this study, we demonstrate that sociodemographic characteristics were not an important factor in patients' use of their PHR, except for education. This study had a small sample size and may not have been large enough to detect differences between groups. Our results did demonstrate that there is a difference between PHR users and nonusers related to their CSE. This work suggests that incorporating CSE into the design of PHRs is critical. The design of patient-facing tools must take into account patients' preferences and abilities when developing effective user-friendly health information technologies.

Roadmap to a more useful and usable electronic health record.

Background: A decade after the Health Information Technology for Economic and Clinical Health (HITECH) Act, electronic health records (EHRs) largely remain poorly designed and contribute to clinician burnout. Objective: The purpose of this study was to understand clinicians' wants, needs, and perceived barriers imposed by the EHR; implement best practices in user-centered design; and create a clinician-centered EHR framework validated via a functional EHR prototype. Methods: Usability evaluations were performed using a simulated patient with a complex clinical scenario. Convergent parallel mixed methods linked to action research and agile development were used to create an EHR prototype based on clinician-centered design. Prototype functionality was validated via a final usability evaluation. Results: Between 2015 and 2017, 53 clinicians from 8 cardiology practices (4 academic and 4 private) participated in initial evaluations of their installed EHR. In 2019, 25 clinicians participated in final evaluations of their EHR vs our EHR prototype. Initial evaluations documented that clinicians judged the EHRs as poorly designed, scoring a mean of 47.1 on the System Usability Scale. Clinicians expressed that EHRs impeded workflow and communication and prolonged their workday. In the final evaluations, no improvement in installed EHRs was found (mean score 48.1); however, the EHR prototype was assessed as significantly more usable (mean score 77.8; P <.001). Conclusion: A decade after the HITECH Act, EHRs still receive low usability scores. By applying user-centered design, an EHR prototype with improved features, functionality, and workflow integration was developed. Clinician testing of the EHR prototype demonstrated it was significantly more useful and usable to clinicians, thus identifying a framework and pathway for substantive improvement of EHR systems.

Impact of Age on Patients' Communication and Technology Preferences in the Era of Meaningful Use: Mixed Methods Study.

BACKGROUND: Identifying effective means of communication between patients and their health care providers has a positive impact on patients' satisfaction, adherence, and health-related outcomes. OBJECTIVE: This study aimed to identify the impact of patients' age on their communication and technology preferences when managing their health. We hypothesize that a patient's age affects their communication and technology preferences when interacting with clinicians and managing their health. METHODS: A mixed methods study was conducted to identify the preferences of patients with cardiovascular diseases. Results were analyzed based on the patients' age. Grounded theory was used to analyze the qualitative data. Patients were recruited based on age, gender, ethnicity, and zip code. RESULTS: A total of 104 patients were recruited: 34 young adults (19-39 years), 33 middle aged (40-64), and 37 senior citizens (>65). Young adults (mean 8.29, SD 1.66) reported higher computer self-efficacy than middle-aged participants (mean 5.56, SD 3.43; P<.05) and senior citizens (mean 47.55, SD 31.23; P<.05). Qualitative analysis identified the following three themes: (1) patient engagement (young adults favored mobile technologies and text messaging, middle-aged patients preferred phone calls, and senior citizens preferred direct interactions with the health care provider); (2) patient safety (young adults preferred electronic after-visit summaries [AVS] and medication reconciliation over the internet; middle-aged patients preferred paper-based or emailed AVS and medication reconciliation in person; senior citizens preferred paper-based summaries and in-person medication reconciliation); (3) technology (young adults preferred smartphones and middle-aged patients and senior citizens preferred tablets or PCs). Middle-aged patients were more concerned about computer security than any other group. A unique finding among senior citizens was the desire for caregivers to have access to their personal health record (PHR). CONCLUSIONS: Patients of different ages have different communication and technology preferences and different preferences with respect to how they would like information presented to them and how they wish to interact with their provider. The PHR is one approach to improving patient engagement, but nontechnological options need to be sustained to support all patients.

Achieving Data Liquidity: Lessons Learned from Analysis of 38 Clinical Registries (The Duke-Pew Data Interoperability Project.

BACKGROUND: To assess the current state of clinical data interoperability, we evaluated the use of data standards across 38 large professional society registries. METHODS: The analysis included 4 primary components: 1) environmental scan, 2) abstraction and cross-tabulation of clinical concepts and corresponding data elements from registry case report forms, dictionaries, and / or data models, 3) cross-tabulation of same across national common data models, and 4) specifying data element metadata to achieve native data interoperability. RESULTS: The registry analysis identified approximately 50 core clinical concepts. None were captured using the same data representation across all registries, and there was little implementation of data standards. To improve technical implementation, we specified 13 key metadata for each concept to be used to achieve data consistency. CONCLUSION: The registry community has not benefitted from and does not contribute to interoperability efforts. A common, authoritative process to specify and implement common data elements is greatly needed.

Worsening renal function in patients with acute decompensated heart failure treated with ultrafiltration: predictors and outcomes.

BACKGROUND: Ultrafiltration (UF) is used to treat patients with diuretic-resistant acute decompensated heart failure. The aim of this study was to identify predictors and the effect of worsening renal failure(WRF) on mortality in patients treated with UF. METHODS AND RESULTS: Based on changes in serum creatinine, 99 patients treated with UF were divided into WRF and control groups. Overall creatinine increased from 1.9 ± 0.7 to 1.2 ± 1.0 mg/dL (P!.001),and WRF developed in 41% of the subjects. The peak UF rate was higher in the WRF group in univariate analysis (174 ± 75 vs 144 ± 52 mL/h; P = .03). Based on multivariate analysis, aldosterone antagonist treatment (odds ratio [OR] 3.38, 95% confidence interval [CI] 1.17-13.46, P = .04), heart rate ≤65 beats/min (OR 6.03, 95% CI 1.48-48.42; P = .03), and E/E0 ≥ 15 (OR 3.78, 95% CI 1.26-17.55; P 5 .04) at hospital admission were associated with WRF. Patients with baseline glomerular filtration rate (GFR) ≤60mg/dL who developed WRF during UF had a 75% 1-year mortality rate. CONCLUSIONS: WRF occurred frequently during UF. Increased LV filling pressures, lower heart rate, and treatment with aldosterone antagonist at hospital admission can identify patients at increased risk for WRF. Patients with baseline GFR ≤60 mg/dL and WRF during UF have an extremely high 1-year mortality rate.

Worsening renal function in patients with acute decompensated heart failure treated with ultrafiltration: predictors and outcomes.

BACKGROUND: Ultrafiltration (UF) is used to treat patients with diuretic-resistant acute decompensated heart failure. The aim of this study was to identify predictors and the effect of worsening renal failure (WRF) on mortality in patients treated with UF. METHODS AND RESULTS: Based on changes in serum creatinine, 99 patients treated with UF were divided into WRF and control groups. Overall creatinine increased from 1.9 ± 9.7 to 2.2 ± 2.0 mg/dL (P < .001), and WRF developed in 41% of the subjects. The peak UF rate was higher in the WRF group in univariate analysis (174 ± 45 vs 144 ± 42 mL/h; P = .03). Based on multivariate analysis, aldosterone antagonist treatment (odds ratio [OR] 3.38, 95% confidence interval [CI] 1.17-13.46, P = .04), heart rate ≤65 beats/min (OR 6.03, 95% CI 1.48-48.42; P = .03), and E/E' ≥15 (OR 3.78, 95% CI 1.26-17.55; P = .04) at hospital admission were associated with WRF. Patients with baseline glomerular filtration rate (GFR) ≤60 mg/dL who developed WRF during UF had a 75% 1-year mortality rate. CONCLUSIONS: WRF occurred frequently during UF. Increased LV filling pressures, lower heart rate, and treatment with aldosterone antagonist at hospital admission can identify patients at increased risk for WRF. Patients with baseline GFR ≤60 mg/dL and WRF during UF have an extremely high 1-year mortality rate.

Diastolic dysfunction in patients with end-stage liver disease is associated with development of heart failure early after liver transplantation.

BACKGROUND: Liver transplantation (LTx) is a life-saving treatment of end-stage liver disease. Cardiac complications including heart failure (HF) are among the leading causes of death after LTx. THE AIM: The aim is to identify clinical and echocardiographic predictors of developing HF after LTx. METHODS: Patients who underwent LTx at the University of Nebraska Medical Center (UNMC) between January 2001 and January 2009 and had echocardiographic study before and within 6 months after transplantation were identified. Patients with coronary artery disease (>70% lesion) were excluded. HF after LTx was defined by clinical signs, symptoms, radiographic evidence of pulmonary congestion, and echocardiographic evidence of left ventricular dysfunction (left ventricle ejection fraction <50%). RESULTS: Among 107 patients (presented as mean age [SD], 55 [10] years; male, 70%) who met the inclusion criteria, 26 (24%) patients developed HF after LTx. The pre-LTx left ventricle ejection fraction did not differ between the HF (69 [7]) and the control groups (69 [7] vs. 67 [6], P=0.30). However, pre-LTx elevation of early mitral inflow velocity/mitral annular velocity (P=0.02), increased left atrial volume index (P=0.05), and lower mean arterial pressure (P=0.03) were predictors of HF after LTx in multivariate analysis. Early mitral inflow velocity/mitral annular velocity greater than 10 and left atrial volume index 40 mL/m2 or more were associated with a 3.4-fold (confidence interval, 1.2-9.4; P=0.017) and 2.9-fold (confidence interval, 1.1-7.5; P=0.03) increase in risk of development of HF after LTx, respectively. CONCLUSIONS: This study suggests that elevated markers of diastolic dysfunction during pre-LTx echocardiographic evaluation are associated with an excess risk of HF and may predict post-LTx survival.