Comprehensive analysis of same day discharge after atrial fibrillation ablation: Clinical, cost, and patient reported outcomes.

BACKGROUND: Same day discharge (SDD) following atrial fibrillation (AF) ablation procedure has emerged as routine practice, and primarily driven by operator discretion. However, the impacts of SDD on clinical outcomes, healthcare system costs, and patient reported outcomes (PROs) have not been systematically studied. METHODS: We retrospectively analyzed patients undergoing routine AF ablation procedures with SDD versus overnight observation (NSDD). After propensity adjustment we compared postprocedure adverse events (AEs), healthcare system costs, and changes in PROs. RESULTS: We identified 310 cases, with 159 undergoing SDD and 151 staying at least one midnight in the hospital (NSDD). Compared with NSDD, SDD patients were similar age (mean 64 vs. 66, p = 0.3), sex (26% female vs. 27%, p = 0.8), and with lower mean CHADS2-VA2Sc scores (2.0 vs. 2.7; p < 0.011). The primary outcome of AEs was noninferior in SDD versus NSDD patients (odds ratio 0.45, 95% confidence interval 0.21-0.99; noninferiority margin of 10%). There were also no differences in overall cost to the healthcare system between SDD and NSDD (p = 0.11). PROs numerically favored SDD (p = NS for all scores). CONCLUSIONS: Physician selection for SDD appears at least as safe as NSDD with respect to clinical outcomes and SDD is not significantly less costly to the health system. There is a trend towards more favorable, general PROs among SDD patients. Routine SDD should be strongly considered for patients undergoing routine AF ablation procedures.

Patient-reported Symptomatic Events Do Not Adequately Reflect Atrial Arrhythmia.

BACKGROUND: Management of atrial fibrillation is frequently geared towards improving symptoms. Yet, the magnitude of symptom rhythm discordance is not well known in the setting of ambulatory electrocardiographic (AECG) monitoring. OBJECTIVE: We aimed to quantify the symptom rhythm correlation for atrial arrhythmia (AT/AF) events. METHODS: This was a retrospective cohort analysis of AECG data at a tertiary care center. All AECGs of >7 days with at least one AT/AF were included. Patient-triggered symptoms included shortness of breath, tiredness, palpitations, dizziness, or passing out with or without concurrent AT/AF. Symptom-rhythm correlation (SRC) was calculated for each patient. Additionally, AT/AF-Symptom association was evaluated at the event level using multivariable mixed effects logistic regression. RESULTS: We identified 742 patients with qualifying AECG data; mean age was 64 years, 50% were female, 22% had heart failure, and mean CHA2DS2-VASc score was 2.5. There were 6,289 symptomatic events and 6,900 ATAF episodes. Among symptomatic events 1013(16%) had shortness of breath, 839(13%) tiredness, 2640(42%) palpitations, 783(12%) dizziness, and 93(1%) with passing out. Overall SRC was 0.39(range 0-1.0), but presence of ATAF increased odds of symptoms by ∼8.3 times in adjusted analyses(p<0.01). In multivariable analysis, prior AF rhythm control treatment and lower heart rate were associated with worse SRC(p<0.01). CONCLUSION: While ATAF events increase the chances of symptoms, there is poor overall correlation between symptomatic events and documented ATAF. Patient factors and prior treatments influence symptom-rhythm correlation. An improved understanding of this relationship correlation is needed to optimize clinical outcomes and improve the rigor of AF research.

Characteristics of a transgender and gender-diverse patient population in Utah: Use of electronic health records to advance clinical and health equity research.

Transgender and gender-diverse (TGD) people, individuals whose gender identity differs from their sex assigned at birth, face unique challenges in accessing gender-affirming care and often experience disparities in a variety of health outcomes. Clinical research on TGD health is limited by a lack of standardization on how to best identify these individuals. The objective of this retrospective cohort analysis was to accurately identify and describe TGD adults and their use of gender-affirming care from 2003-2023 in a healthcare system in Utah, United States. International Classification of Disease (ICD)-9 and 10 codes and surgical procedure codes, along with sexual orientation and gender identity data were used to develop a dataset of 4,587 TGD adults. During this time frame, 2,985 adults received gender-affirming hormone therapy (GAHT) and/or gender-affirming surgery (GAS) within one healthcare system. There was no significant difference in race or ethnicity between TGD adults who received GAHT and/or GAS compared to TGD adults who did not receive such care. TGD adults who received GAHT and/or GAS were more likely to have commercial insurance coverage, and adults from rural communities were underrepresented. Patients seeking estradiol-based GAHT tended to be older than those seeking testosterone-based GAHT. The first GAS occurred in 2013, and uptake of GAS have doubled since 2018. This study provides a methodology to identify and examine TGD patients in other health systems and offers insights into emerging trends and access to gender-affirming care.

Helix-fixed leadless pacemaker implantation through a valve-in-valve tricuspid prosthesis via the femoral approach.

Leadless pacemakers offer the opportunity to avoid transvenous hardware among patients with tricuspid valve prostheses. We present the first case of a helix-based fixation leadless pacemaker implanted through valve-in-valve tricuspid prostheses in a 43-year-old female with extensive prior cardiac history. At the time of presentation, epicardial pacing was no longer a viable option in the setting of pacemaker dependence. Placement of a helix-fixed, leadless right ventricular pacemaker was performed as a bridge to dual-chamber leadless pacing. This was safely and effectively performed and highlighted favorable procedural characteristics that included RV cavity dimensions and prosthesis type.

Ablation-induced left atrial mechanical dysfunction recovers in weeks after ablation.

BACKGROUND: The immediate impact of catheter ablation on left atrial mechanical function and the timeline for its recovery in patients undergoing ablation for atrial fibrillation (AF) remain uncertain. The mechanical function response to catheter ablation in patients with different AF types is poorly understood. METHODS: A total of 113 AF patients were included in this retrospective study. Each patient had three magnetic resonance imaging (MRI) studies in sinus rhythm: one pre-ablation, one immediate post-ablation (within 2 days after ablation), and one post-ablation follow-up MRI (≤ 3 months). We used feature tracking in the MRI cine images to determine peak longitudinal atrial strain (PLAS). We evaluated the change in strain from pre-ablation, immediately after ablation to post-ablation follow-up in a short-term study (< 50 days) and a 3-month study (3 months after ablation). RESULTS: The PLAS exhibited a notable reduction immediately after ablation, compared to both pre-ablation levels and those observed in follow-up studies conducted at short-term (11.1 ± 9.0 days) and 3-month (69.6 ± 39.6 days) intervals. However, there was no difference between follow-up and pre-ablation PLAS. The PLAS returned to 95% pre-ablation level within 10 days. Paroxysmal AF patients had significantly higher pre-ablation PLAS than persistent AF patients in pre-ablation MRIs. Both type AF patients had significantly lower immediate post-ablation PLAS compared with pre-ablation and post-ablation PLAS. CONCLUSION: The present study suggested a significant drop in PLAS immediately after ablation. Left atrial mechanical function recovered within 10 days after ablation. The drop in PLAS did not show a substantial difference between paroxysmal and persistent AF patients.

Expedited loading with intravenous sotalol is safe and feasible-primary results of the Prospective Evaluation Analysis and Kinetics of IV Sotalol (PEAKS) Registry.

BACKGROUND: Loading of oral sotalol for atrial fibrillation requires 3 days, frequently in the hospital, to achieve steady state. The Food and Drug Administration approved loading with intravenous (IV) sotalol through model-informed development, without patient data. OBJECTIVE: We present results of the first multicenter evaluation of this recent labeling for IV sotalol. METHODS: The Prospective Evaluation Analysis and Kinetics of IV Sotalol (PEAKS) Registry was a multicenter observational registry of patients undergoing elective IV sotalol load for atrial arrhythmias. Outcomes, measured from hospital admission until first outpatient follow-up, included adverse arrhythmia events, efficacy, and length of stay. RESULTS: Of 167 consecutively enrolled patients, 23% were female; the median age was 68 (interquartile range, 61-74) years, and the median CHA2DS2-VASc score was 3 (interquartile range, 2-4). Overall, 99% were admitted for sotalol initiation (1% for dose escalation), with a target oral sotalol dose of either 80 mg twice daily (85 [51%]) or 120 mg twice daily (78 [47%]); 62 patients (37%) had an estimated creatinine clearance ≤90 mL/min. On presentation, 40% of patients were in sinus rhythm, whereas 26% underwent cardioversion before sotalol infusion. In 2 patients, sotalol infusion was stopped for bradycardia or hypotension. In 6 patients, sotalol was discontinued before discharge because of QTc prolongation (3), bradycardia (1), or recurrent atrial arrhythmia (2). The mean length of stay was 1.1 days, and 95% (n = 159) were discharged within 1 night. CONCLUSION: IV sotalol loading is safe and feasible for atrial arrhythmias, with low rates of adverse events, and yields shorter hospitalizations. More data are needed on the minimal duration required for monitoring in the hospital.

Leadless pacemaker tine damage and fracture: novel complications of a novel device fixation mechanism.

Background: Leadless pacemakers represent a paradigm-changing advancement. However, they required innovative and novel device design, including the use of nitinol tines for fixation. Objective: We aimed to understand the potential for fracture in the novel tine-based fixation mechanism. Methods: A retrospective approach was used to search the MAUDE (Manufacturer and User Facility Device Experience) database for events related to Micra pacemaker tine fracture and damage. Review of each report was performed to ascertain frequency of tine fracture and damage. Results: Of 4241 MAUDE reports (2104 Micra VR, 2167 Micra AV), 230 included the terms "fracture" or "tine," which yielded 7 tine fractures and 19 reports of tine damage. Overall, 2 (29%) of 7 tine fractures were noted during implantation, whereas 2 (29%) of 7 were discovered ≥1 week after implantation; 5 (71%) of 7 tine fracture reports described no associated patient signs or symptoms, and 4 (57%) of 7 described no change in pacing parameters. Tine damage occurred during implantation in 16 (84%) of 19, compared with 2 (11%) of 19 noted ≥1 week after implantation; 15 (79%) of 19 tine damage cases reported no associated signs or symptoms, and 7 (37%) of 19 described no changes in pacing parameters. Among all cases, there was 1 case of device embolization. Conclusion: The novel tine-based fixation mechanism appears susceptible to a novel failure mechanism-tine fracture and/or damage. Our analysis suggests these events may not always be associated with adverse signs or symptoms. Diligent attention at implantation, and future bench or clinical studies are needed to understand the rate, clinical impact, and mechanism of such failures, and role of surveillance.

Mortality benefit with AF ablation: Impact of normal sinus rhythm seen in CABANA and EAST AFnet.

Atrial fibrillation (AF) is significantly associated with morbidity and mortality and erodes the quality and quantity of life. It is standard of care to treat patients with AF and an increased risk of stroke with oral anticoagulation therapy, but the more daunting question many clinicians face is whether to pursue a "rate-only" or "rhythm" control strategy. Historical studies over the years have sought to answer this question but have found no significant difference in major clinical outcomes between the two strategies. There are opportunities based on new data to improve the natural history of the disease. The EAST AFnet trial for the first time revealed a significant morbidity and mortality advantage to rhythm control therapy when performed early in the disease process of AF and in the setting of comprehensive medical management that was maintained. The CABANA trial clearly demonstrated that catheter ablation was a more effective long-term treatment of AF in general and significantly lowers risk of AF progression compared to medical therapy. Like multiple prior trials of rhythm management strategies, when rhythm control was effective in these trials, independent of therapy assignment, there was a significantly lower risk of adverse outcomes and death. These contemporary data provide optimism that the pervasive mortality risk in patients with AF observed over the past 50 years may be improved by the timing, use, and efficacy of use of therapeutic interventions.

Modelling anticoagulation and health-related quality of life in those with atrial fibrillation: a secondary analysis of AFFIRM.

Associations of anticoagulation with primary endpoints in longitudinal studies are impacted by selection bias and time-varying covariates (e.g. comorbidities). We demonstrate how time-varying covariates and selection bias influence association estimates between anticoagulation and health-related quality of life (HRQoL) in patients with atrial fibrillation. We performed a secondary analysis of the Atrial Fibrillation Follow-up Investigation of Rhythm Management trial quality of life substudy. Dichotomized warfarin use was ascertained at the study baseline, 2 months later, and annually for up to 6 years. HRQoL was measured at every time point using a self-reported ordinal 5-point Likert-scale (lower score and lower odds ratio represents better health-related quality of life). Static and time-varying covariates were ascertained throughout the study period. Confounder-adjusted generalized mixed model and generalized estimating equation regressions were used to demonstrate traditional association estimates between anticoagulation and HRQoL. Inverse probability of treatment and censorship weights were used to ascertain the influence of time-varying confounding and selection bias. Age-stratified analysis (age ≥ 70 years) evaluated for effect modification. 656 individuals were included in the analysis, 601 on warfarin at baseline. The association of warfarin use with better HRQoL over time strengthened when accounting for time-varying confounding and selection bias (OR 0.30, 95% CI 0.14-0.55) compared to traditional analyses (OR 0.61, 95% CI 0.38-0.97), and was most pronounced in those ≥ 70 years upon stratified analysis. Anticoagulation is associated with higher HRQoL in patients with atrial fibrillation, with time-varying confounding and selection bias likely influencing longitudinal estimates in anticoagulation-HRQoL research.

Performance of Off-the-Shelf Machine Learning Architectures and Biases in Detection of Low Left Ventricular Ejection Fraction.

Artificial intelligence - machine learning (AI-ML) is a computational technique that has been demonstrated to be able to extract meaningful clinical information from diagnostic data that are not available using either human interpretation or more simple analysis methods. Recent developments have shown that AI-ML approaches applied to ECGs can accurately predict different patient characteristics and pathologies not detectable by expert physician readers. There is an extensive body of literature surrounding the use of AI-ML in other fields, which has given rise to an array of predefined open-source AI-ML architectures which can be translated to new problems in an "off-the-shelf" manner. Applying "off-the-shelf" AI-ML architectures to ECG-based datasets opens the door for rapid development and identification of previously unknown disease biomarkers. Despite the excellent opportunity, the ideal open-source AI-ML architecture for ECG related problems is not known. Furthermore, there has been limited investigation on how and when these AI-ML approaches fail and possible bias or disparities associated with particular network architectures. In this study, we aimed to: (1) determine if open-source, "off-the-shelf" AI-ML architectures could be trained to classify low LVEF from ECGs, (2) assess the accuracy of different AI-ML architectures compared to each other, and (3) to identify which, if any, patient characteristics are associated with poor AI-ML performance.

Major drivers of healthcare system costs and cost variability for routine atrial fibrillation ablation.

Background: Catheter ablation is an effective treatment for atrial fibrillation (AF) but incurs significant financial costs to payers. Reducing variability may improve cost effectiveness. Objectives: We aimed to measure (1) the components of direct and indirect costs for routine AF ablation procedures, (2) the variability of those costs, and (3) the main factors driving ablation cost variability. Methods: Using data from the University of Utah Health Value Driven Outcomes system, we were able to measure direct, inflation-adjusted costs of uncomplicated, routine AF ablation to the healthcare system. Direct costs were considered costs incurred by pharmacy, disposable supplies, patient labs, implants, and other services categories (primarily anesthesia support) and indirect costs were considered within imaging, facility, and electrophysiology lab management categories. Results: A total of 910 patients with 1060 outpatient ablation encounters were included from January 1, 2013, to December 31, 2020. Disposable supplies accounted for the largest component of cost with 44.8 ± 9.7%, followed by other services (primarily anesthesia support) with 30.4 ± 7.7% and facility costs with 16.1 ± 5.6%; pharmacy, imaging, and implant costs each contributed <5%. Direct costs were larger than indirect costs (82.4 ± 5.6% vs 17.6 ± 5.6%). Multivariable regression showed that procedure operator was the primary factor associated with AF ablation overall cost (up to 12% differences depending on operator). Conclusions: Direct costs and other services (primarily anesthesia) drive the majority costs associated with AF ablations. There is significant variability in costs for these routine, uncomplicated AF ablation procedures. The procedure operator, and not patient characteristic, is the main driver for cost variability.