Real-world data of radiofrequency catheter ablation in paroxysmal atrial fibrillation: Short- and long-term clinical outcomes from the prospective multicenter REAL-AF Registry.

BACKGROUND: The safety and long-term efficacy of radiofrequency (RF) catheter ablation (CA) of paroxysmal atrial fibrillation (PAF) has been well established. Contemporary techniques to optimize ablation delivery, reduce fluoroscopy use, and improve clinical outcomes have been developed. OBJECTIVE: The purpose of this study was to assess the contemporary real-world practice approach and short and long-term outcomes of RF CA for PAF through a prospective multicenter registry. METHODS: Using the REAL-AF (Real-world Experience of Catheter Ablation for the Treatment of Symptomatic Paroxysmal and Persistent Atrial Fibrillation; ClincalTrials.gov Identifier: NCT04088071) Registry, patients undergoing RF CA to treat PAF across 42 high-volume institutions and 79 experienced operators were evaluated. The procedures were performed using zero or reduced fluoroscopy, contact force sensing catheters, wide area circumferential ablation, and ablation index as a guide with a target of 380-420 for posterior and 500-550 for anterior lesions. The primary efficacy outcome was freedom from all-atrial arrhythmia recurrence at 12 months. RESULTS: A total of 2470 patients undergoing CA from January 2018 to December 2022 were included. Mean age was 65.2 ±11.14 years, and 44% were female. Most procedures were performed without fluoroscopy (71.5%), with average procedural and total RF times of 95.4 ± 41.7 minutes and 22.1±11.8 minutes, respectively. At 1-year follow-up, freedom from all-atrial arrhythmias was 81.6% with 89.7% of these patients off antiarrhythmic drugs. No significant difference was identified comparing pulmonary vein isolation vs pulmonary vein isolation plus ablation approaches. The complication rate was 1.9%. CONCLUSION: Refinement of RF CA to treat PAF using contemporary tools, standardized protocols, and electrophysiology laboratory workflows resulted in excellent short- and long-term clinical outcomes.

Towards a shared understanding of the learning health system in a large academic-based health system: A qualitative analysis.

Healthcare delivery is currently undergoing major structural reform, and the Learning Health System (LHS) has been proposed as an aspirational model to guide healthcare transformation. As efforts to build LHS take considerable investment from health systems, it is critical to understand their leaders' perspectives on the rationale for pursuing an LHS and the potential benefits for doing so. This paper describes the qualitative analysis of semi-structured interviews (n = 17) with health system leaders about their general perceptions of the LHS, description of key attributes and potential benefits, and perception of barriers to and facilitators for advancing the model. Participants universally endorsed the goal of the local health system aspiring to become an LHS. Participants identified many recognized attributes of LHS, though they emphasized unique attributes and potential benefits. There was also heterogeneity in participants' views on what to prioritize, how to structure the local LHS within existing initiatives, and how new initiatives should be implemented. Improving conceptual clarity of attributes of the LHS would improve its potential in guiding future reform.

Predictors of first pass isolation of the pulmonary veins in real world ablations: An analysis of 2671 patients from the REAL-AF registry.

INTRODUCTION: During atrial fibrillation ablation (AFA), achievement of first pass isolation (FPI) reflects effective lesion formation and predicts long-term freedom from arrhythmia recurrence. We aim to determine the clinical and procedural predictors of pulmonary vein FPI. METHODS: We reviewed AFA procedures in a multicenter prospective registry of AFA (REAL-AF). A multivariate ordinal logistic regression, weighted by inverse proceduralist volume, was used to determine predictors of FPI. RESULTS: A total of 2671 patients were included with 1806 achieving FPI in both vein sides, 702 achieving FPI in one, and 163 having no FPI. Individually, age, left atrial (LA) scar, higher power usage (50 W), greater posterior contact force, ablation index >350 posteriorly, Vizigo™ sheath utilization, nonstandard ventilation, and high operator volume (>6 monthly cases) were all related to improved odds of FPI. Conversely sleep apnea, elevated body mass index (BMI), diabetes mellitus, LA enlargement, antiarrhythmic drug use, and center's higher fluoroscopy use were related to reduced odds of FPI. Multivariate analysis showed that BMI > 30 (OR 0.78 [0.64-0.96]) and LA volume (OR per mL increase = 1.00 [0.99-1.00]) predicted lower odds of achieving FPI, whereas significant left atrial scarring (>20%) was related to higher rates of FPI. Procedurally, the use of high power (50 W) (OR 1.32 [1.05-1.65]), increasing force posteriorly (OR 2.03 [1.19-3.46]), and nonstandard ventilation (OR 1.26 [1.00-1.59]) predicted higher FPI rates. At a site level, high procedural volume (OR 1.89 [1.48-2.41]) and low fluoroscopy centers (OR 0.72 [0.61-0.84]) had higher rates of FPI. CONCLUSION: FPI rates are affected by operator experience, patient comorbidities, and procedural strategies. These factors may be postulated to impact acute lesion formation.

50-W vs 40-W During High-Power Short-Duration Ablation for Paroxysmal Atrial Fibrillation: A Multicenter Prospective Study.

BACKGROUND: High-power short-duration (HPSD) radiofrequency ablation of atrial fibrillation (AF) increases first-pass pulmonary vein isolation (PVI) and freedom from atrial arrhythmias while decreasing procedural time. However, the optimal power setting in terms of safety and efficacy has not been determined. OBJECTIVES: This study compared the procedural characteristics and clinical outcomes of 50-W vs 40-W during HPSD ablation of paroxysmal AF. METHODS: Patients from the REAL-AF prospective multicenter registry (Real-World Experience of Catheter Ablation for Treatment of Symptomatic Paroxysmal and Persistent Atrial Fibrillation) undergoing HPSD ablation of paroxysmal AF, either using 50-W or 40-W, were included. The primary efficacy outcome was freedom from all-atrial arrhythmias. The primary safety outcome was the occurrence of any procedural complication at 12 months. Secondary outcomes included procedural characteristics, AF-related symptoms, and the occurrence of transient ischemic attack or stroke at 12 months. RESULTS: A total of 383 patients were included. Freedom from all-atrial arrhythmias at 12 months was 80.7% in the 50-W group and 77.3% in the 40-W group (Log-rank P = 0.387). The primary safety outcome occurred in 3.7% of patients in the 50-W group vs 2.8% in the 40-W group (P = 0.646). The 50-W group had a higher rate of first-pass PVI (82.3% vs 76.2%; P = 0.040) as well as shorter procedural (67 minutes [IQR: 54-87.5 minutes] vs 93 minutes [IQR: 80.5-111 minutes]; P < 0.001) and radiofrequency ablation times (15 minutes [IQR: 11.4-20 minutes] vs 27 minutes [IQR: 21.5-34.6 minutes]; P < 0.001) than the 40-W group. CONCLUSIONS: There was no significant difference in freedom from all-atrial arrhythmias or procedural safety outcomes between 50-W and 40-W during HPSD ablation of paroxysmal AF. The use of 50-W was associated with a higher rate of first-pass PVI as well as shorter procedural times.

High-Frequency Low-Tidal Volume Ventilation Improves Long-Term Outcomes in AF Ablation: A Multicenter Prospective Study.

BACKGROUND: High-frequency, low-tidal-volume (HFLTV) ventilation is a safe and simple strategy to improve catheter stability and first-pass isolation during pulmonary vein (PV) isolation. However, the impact of this technique on long-term clinical outcomes has not been determined. OBJECTIVES: This study sought to assess acute and long-term outcomes of HFLTV ventilation compared with standard ventilation (SV) during radiofrequency (RF) ablation of paroxysmal atrial fibrillation (PAF). METHODS: In this prospective multicenter registry (REAL-AF), patients undergoing PAF ablation using either HFLTV or SV were included. The primary outcome was freedom from all-atrial arrhythmia at 12 months. Secondary outcomes included procedural characteristics, AF-related symptoms, and hospitalizations at 12 months. RESULTS: A total of 661 patients were included. Compared with those in the SV group, patients in the HFLTV group had shorter procedural (66 [IQR: 51-88] minutes vs 80 [IQR: 61-110] minutes; P < 0.001), total RF (13.5 [IQR: 10-19] minutes vs 19.9 [IQR: 14.7-26.9] minutes; P < 0.001), and PV RF (11.1 [IQR: 8.8-14] minutes vs 15.3 [IQR: 12.4-20.4] minutes; P < 0.001) times. First-pass PV isolation was higher in the HFLTV group (66.6% vs 63.8%; P = 0.036). At 12 months, 185 of 216 (85.6%) in the HFLTV group were free from all-atrial arrhythmia, compared with 353 of 445 (79.3%) patients in the SV group (P = 0.041). HLTV was associated with a 6.3% absolute reduction in all-atrial arrhythmia recurrence, lower rate of AF-related symptoms (12.5% vs 18.9%; P = 0.046), and hospitalizations (1.4% vs 4.7%; P = 0.043). There was no significant difference in the rate of complications. CONCLUSIONS: HFLTV ventilation during catheter ablation of PAF improved freedom from all-atrial arrhythmia recurrence, AF-related symptoms, and AF-related hospitalizations with shorter procedural times.

Insights for Conducting Large-Scale Surveys with Veterans Who Have Experienced Homelessness.

Surveys of underserved patient populations are needed to guide quality improvement efforts but are challenging to implement. The goal of this study was to describe recruitment and response to a national survey of Veterans with homeless experience (VHE). We randomly selected 14,340 potential participants from 26 U.S. Department of Veterans Affairs (VA) facilities. A survey contract organization verified/updated addresses from VA administrative data with a commercial address database, then attempted to recruit VHE through 4 mailings, telephone follow-up, and a $10 incentive. We used mixed-effects logistic regressions to test for differences in survey response by patient characteristics. The response rate was 40.2% (n=5,766). Addresses from VA data elicited a higher response rate than addresses from commercial sources (46.9% vs 31.2%, p<.001). Residential addresses elicited a higher response rate than business addresses (43.8% vs 26.2%, p<.001). Compared to non-respondents, respondents were older, less likely to have mental health, drug, or alcohol conditions, and had fewer VA housing and emergency service visits. Collectively, our results indicated a national mailed survey approach is feasible and successful for reaching VA patients who have recently experienced homelessness. These findings offer insight into how health systems can obtain perspectives of socially disadvantaged groups.

Performance of the REAL-AF Same-Day Discharge Protocol in Patients Undergoing Catheter Ablation of Atrial Fibrillation.

BACKGROUND: Same-day discharge (SDD) after catheter ablation of atrial fibrillation (AF) has been widely adopted. Nevertheless, planned SDD has been performed by using subjective criteria rather than standardized protocols. OBJECTIVES: The goal of this study was to determine the efficacy and safety of the previously described SDD protocol in a prospective multicenter study. METHODS: Using the REAL-AF (Real-world Experience of Catheter Ablation for the Treatment of Paroxysmal and Persistent Atrial Fibrillation) SDD protocol eligibility criteria (stable anticoagulation, no bleeding history, left ventricular ejection fraction >40%, no pulmonary disease, no procedures within 60 days, and body mass index <35 kg/m2), operators prospectively determined whether patients undergoing ablation of AF were candidates for SDD (SDD vs non-SDD groups). Successful SDD was achieved if the patient met the protocol discharge criteria. The primary efficacy endpoint was the success rate of SDD. The primary safety endpoints were readmission rates as well as acute and subacute complications. The secondary endpoints included procedural characteristics and freedom from all-atrial arrhythmias. RESULTS: A total of 2,332 patients were included. The REAL-AF SDD protocol identified 1,982 (85%) patients as potential candidates for SDD. The primary efficacy endpoint was achieved in 1,707 (86.1%) patients. The readmission rate for SDD vs non-SDD group was similar (0.8% vs 0.9%; P = 0.924). The SDD group had a lower acute complication rate than the non-SDD group (0.8% vs 2.9%; P < 0.001), and there was no difference in the subacute complication rate between groups (P = 0.513). Freedom from all-atrial arrhythmias was comparable between groups (P = 0.212). CONCLUSIONS: In this large, multicenter prospective registry, the use of a standardized protocol showed the safety of SDD after catheter ablation of paroxysmal and persistent AF. (Real-world Experience of Catheter Ablation for the Treatment of Paroxysmal and Persistent Atrial Fibrillation [REAL-AF]; NCT04088071).

Higher Pain Catastrophizing and Preoperative Pain is Associated with Increased Risk for Prolonged Postoperative Opioid Use.

BACKGROUND: Prolonged postoperative opioid use (PPOU) is considered an unfavorable post-surgical outcome. Demographic, clinical, and psychosocial factors have been associated with PPOU, but methods to prospectively identify patients at increased risk are lacking. OBJECTIVES: Our objective was to determine whether an individual or a combination of several psychological factors could identify a subset of patients at increased risk for PPOU. STUDY DESIGN: Observational cohort study with prospective baseline data collection and passive outcomes data collection. SETTING: A single VA medical center in the United States. METHODS: Patients were recruited from a preoperative anesthesia clinic where they were undergoing evaluation prior to elective surgery, and they completed a survey before surgery. The primary outcome was PPOU, defined as outpatient receipt of a prescribed opioid 31 to 90 days after surgery as determined from pharmacy records. Primary covariates of interest were pain catastrophizing, self-efficacy, and optimism. Additional covariates included social and demographic factors, pain severity, medication use, depression, anxiety, and surgical fear. RESULTS: Of 123 patients included in the final analyses, 30 (24.4%) had PPOU. In bivariate analyses, preoperative opioid use and preoperative nonsteroidal anti-inflammatory drug use were significantly associated with PPOU. The combination of high pain catastrophizing and high preoperative pain (OR 3.32, 95% CI 1.41 - 7.79) was associated with higher odds of PPOU than either alone, and the association remained significant after adjusting for preoperative opioid use (OR 2.56, 95% CI 1.04 - 6.29). LIMITATIONS: Patients were recruited from a single site, and the sample was not large enough to include potentially important variables such as procedure type. CONCLUSIONS: A combination of high pain catastrophizing and high preoperative pain has the potential to be a clinically useful means of identifying patients at elevated risk of PPOU.

Steerable sheath visualizable under 3D electroanatomical mapping facilitates paroxysmal atrial fibrillation ablation with minimal fluoroscopy.

BACKGROUND: Advances in technology and workflows have facilitated substantial reductions in fluoroscopy utilization and procedure times for atrial fibrillation (AF) ablations. A recently available steerable sheath, visualizable on a 3D electroanatomical map (EAM), may further simplify low/zero fluoroscopy ablation workflows by facilitating understanding of the relative positions of the catheter and sheath. The objective of this study was to demonstrate feasibility, safety, procedural efficiency, and clinical effectiveness of incorporating the new visualizable sheath into a low-fluoroscopy workflow. METHODS: Consecutive de novo paroxysmal AF procedures were performed with a porous tip contact force catheter at a high-volume site between January 2018 and May 2019. Procedures performed with and without the VIZIGO™ EAM-visualizable sheath (Vizigo) were compared. All ablations employed the same standardized low-fluoroscopy workflow. Statistical analyses employed stabilized inverse probability of treatment weights (IPTW) to balance cohorts by operator and key patient characteristics. RESULTS: Cohorts of 142 Vizigo and 173 non-Vizigo patients were similar at baseline. Use of the Vizigo sheath was associated with approximately 10% improvement in catheter stability (p = 0.0005), 16% reduction in radiofrequency time (p < 0.0001), and 7% fewer ablations that used fluoroscopy (p = 0.0030). There was one cardiac tamponade in each cohort and no deaths, atrioesophageal fistulas, or strokes. Single-procedure freedom from atrial arrhythmia recurrence through 12 months was similar between cohorts (p = 0.9556). CONCLUSIONS: Use of a 3D EAM-visualizable sheath resulted in improved catheter stability, reduced radiofrequency time, and more procedures performed without fluoroscopy, without compromise to safety or effectiveness.

Sensitivity of health records for self-reported nonfatal drug and alcohol overdose.

BACKGROUND AND OBJECTIVES: Public health surveillance for overdose sometimes depends on nonfatal drug overdoses recorded in health records. However, the proportion of total overdoses identified through health record systems is unclear. Comparison of overdoses from health records to those that are self-reported may provide insight on the proportion of nonfatal overdoses that are not identified. METHODS: We conducted a cohort study linking survey data on overdose from a national survey of Veterans to United States Department of Veterans Affairs (VA) health records, including community care paid for by VA. Self-reported overdose in the prior 3 years was compared to diagnostic codes for overdoses and substance use disorders in the same time period. RESULTS: The sensitivity of diagnostic codes for overdose, compared to self-report as a reference standard for this analysis, varied by substance: 28.1% for alcohol, 23.1% for sedatives, 12.0% for opioids, and 5.5% for cocaine. There was a notable concordance between substance use disorder diagnoses and self-reported overdose (sensitivity range 17.9%-90.6%). DISCUSSION AND CONCLUSIONS: Diagnostic codes in health records may not identify a substantial proportion of drug overdoses. A health record diagnosis of substance use disorder may offer a stronger inference regarding the size of the population at risk. Alternatively, screening for self-reported overdose in routine clinical care could enhance overdose surveillance and targeted intervention. SCIENTIFIC SIGNIFICANCE: This study suggests that diagnostic codes for overdose are insensitive. These findings support consideration of alternative approaches to overdose surveillance in public health.

What do Veterans with homeless experience want us to know that we are not asking? A qualitative content analysis of comments from a national survey of healthcare experience.

Surveys of people who experience homelessness can portray their life and healthcare experiences with a level of statistical precision; however, few have explored how the very same surveys can deliver qualitative insights as well. In responding to surveys, people experiencing homelessness can use the margins to highlight health and social concerns that investigators failed to anticipate that standard question batteries miss. This study describes the unprompted comments of a large national survey of Veterans with homeless experiences. The Primary Care Quality-Homeless Services Tailoring (PCQ-HOST) survey presented 85 close-ended items to solicit social and psychological experiences, health conditions, and patient ratings of primary care. Amongst 5377 Veterans responding to the paper survey, 657 (12%) offered 1933 unprompted comments across nearly all domains queried. Using a team-based content analysis approach, we coded and organised survey comments by survey domain, and identified emergent themes. Respondents used comments for many purposes. They noted when questions called for more nuanced responses than those allowed, especially 'sometimes' or 'not applicable' on sensitive questions, such as substance use, where recovery status was not queried. On such matters, the options of 'no' and 'yes' failed to capture important contextual and historical information that mattered to respondents, such as being in recovery. Respondents also elaborated on negative and positive care experiences, often naming specific clinics or clinicians. This study highlights the degree to which members of vulnerable populations, who participate in survey research, want researchers to know the reasons behind their responses and topics (like chronic pain and substance use disorders) that could benefit from open-ended response options. Understanding patient perspectives can help improve care. Quantitative data from surveys can provide statistical precision but may miss key patient perspectives. The content that patients write into survey margins can highlight shortfalls of a survey and point towards future areas of inquiry. Veterans with homeless experience want to provide additional detail about their lives and care experiences in ways that transcend the boundaries of close-ended survey questions. Questions on substance use proved especially likely to draw comments that went beyond the permitted response options, often to declare that the respondent was in recovery. Respondents frequently clarified aspects of their care experiences related to pain, pain care, transportation and experiences of homelessness.

Adapting an Interdisciplinary Learning Health System Framework for Academic Health Centers: A Scoping Review.

PURPOSE: Learning health systems (LHSs), defined as a systematic process for aligning science, informatics, and clinical practice to integrate providers, researchers, and patients as active participants in an evidence-based care continuum, can provide an ideal environment for academic health centers to rapidly adopt evidence-based guidelines and translate research into practice. However, few LHS frameworks are specifically adapted for academic health centers. The authors wanted to identify the definitions, components, and other features of LHSs to develop an interdisciplinary LHS framework for use within academic health centers. METHOD: The authors conducted a scoping review of the literature to identify definitions, components, and other features of LHSs that are useful to academic health centers. In January 2021, they searched PubMed, Academic Search Premier, and Scopus databases and identified English-language, peer-reviewed articles pertaining to LHS, LHS frameworks, organization, components, and models. Since the phrase learning health system is relatively new terminology, they conducted a supplemental review with alternative phrases, including embedded research and coordinated or collaborative research network . They used the Knowledge to Action (KTA) Framework to integrate the generation and flow of research into practice. RESULTS: The primary review retrieved 719 articles and the supplemental review retrieved 209; of these, 49 articles were retained to synthesize common definitions, components, and other features of LHS frameworks. Seven structural components of LHSs were identified: organization and collaborations, performance, ethics and security, scientific approaches, data, information technology, and patient outcomes. An adapted interdisciplinary LHS framework was developed that incorporated research and learning engines derived from the KTA and adaptations of common components and other features within the reviewed articles to fit the interests of providers, researchers, and patients within academic health centers. CONCLUSIONS: The adapted LHS framework can be used as a dynamic foundation for development and organization of interdisciplinary LHSs within academic health centers.

Practice Patterns of Operators Participating in the Real-World Experience of Catheter Ablation for Treatment of Symptomatic Paroxysmal and Persistent Atrial Fibrillation (REAL-AF) Registry.

BACKGROUND: The Real-World Experience of Catheter Ablation for Treatment of Symptomatic Paroxysmal and Persistent Atrial Fibrillation (REAL-AF) is a multicenter prospective registry of atrial fibrillation (AF) ablation. We sought to describe the baseline workflows of REAL-AF operators. METHODS: REAL-AF enrolls high volume minimum fluoroscopy radiofrequency ablators. A 150 item questionnaire was administered to participating operators. Responses were analyzed using standard methods. RESULTS: Forty-two respondents had a mean 178.2 ± 89.2 yearly AF ablations, with 42.4 ± 11.9% being paroxysmal (PAF). Most operators performed ablation with uninterrupted or minimally interrupted anticoagulation (66.7% and 28.6%). Left atrial appendage (LAA) thrombus was most commonly ruled out with transesophageal echocardiography (33.3% and 42.9% for PAF and persistent AF). Consistent with registry design, radiofrequency energy (92.1% ± 18.8% of cases) and zero fluoroscopy ablation (73.8% goal 0 fluoroscopy) were common. The majority of operators relied on index-guided ablation (90.5%); Mean Visitag surpoint targets were higher anteriorly vs posteriorly (508.3 ± 49.8 vs 392.3 ± 37.0, p < 0.01), but power was similar. There was considerable heterogeneity related to gaps in current knowledge, such as lesion delivery targets and sites of extra-pulmonary vein ablation (most common was the posterior wall followed by the roof). Peri-procedural risk factor management of obesity, hypertension, and sleep apnea was common. There was a mean of 3.0 ± 1.2 follow-up visits at 12 months. CONCLUSIONS: REAL-AF operators were high volume low fluoroscopy "real world" operators with good follow-up and adherence to known best-practices. There was disagreement related to knowledge gaps in guidelines.

Designing an Efficient and Quality-focused Integrated Atrial Fibrillation Care Center.

Atrial fibrillation (AF) represents a significant health care burden in the United States that will continue to increase as the population ages; thus, the introduction of cost-effective strategies to limit this burden is critical. The establishment of dedicated electrophysiology programs focusing on AF care within hospitals can improve patient care while providing added financial benefits for institutions if properly planned and delivered. This paper explains how to develop an efficient and quality-focused AF ablation program as part of a larger AF center of excellence by highlighting the experience of a single center and demonstrating how the same principles were adopted to implement a similar program at another institution.

Characteristics Associated With Unsheltered Status Among Veterans.

INTRODUCTION: Unsheltered homelessness is a strongly debated public issue. The study objective is to identify personal and community characteristics associated with unsheltered homelessness in veterans and to test for interactions between these characteristics. METHODS: In a 2018 national survey of U.S. veterans with homeless experiences; investigators assessed unsheltered time; psychosocial characteristics; and community measures of shelter access, weather, and rental affordability. Associations between these characteristics and unsheltered status were tested in July-August 2020. This study also tested whether the count of personal risk factors interacted with community characteristics in predicting unsheltered status. RESULTS: Among 5,406 veterans, 481 (8.9%) reported ≥7 nights unsheltered over 6 months. This group was more likely to report criminal justice history, poor social support, medical and drug problems, financial hardship, and being unmarried. Their communities had poorer shelter access and warmer temperatures. The likelihood of unsheltered experience rose with risk factor count from 2.0% (0-1) to 8.4% (2-3) and to 24.2% (4-11). Interaction tests showed that the increase was greater for communities with warmer weather and higher rents (p<0.05). CONCLUSIONS: Among veterans experiencing homelessness, unsheltered experiences correlate with individual and community risk factors. Communities wishing to address unsheltered homelessness will need to consider action at both levels.