Journal of comparative effectiveness research最新文献

{"title":"Covariate selection and adjustment for efficacy and safety endpoints in indirect comparative effectiveness analyses of CAR-T-cell therapies for large B-cell lymphoma: a systematic review.","authors":"Marie A-C Neumann, Jonas Jost, Sybille Riou, Stefanie Rungaldier, Stefan Walzer, Jörg Mahlich","doi":"10.57264/cer-2026-0033","DOIUrl":"10.57264/cer-2026-0033","url":null,"abstract":"<p><p><b>Aim:</b> Several CAR-T cell therapies have received regulatory approval from both the US FDA and the EMA for the treatment of large B-cell lymphoma. However, direct comparative trials between CAR-T cell therapies are lacking, mainly due to different clinical development timelines and availabilities as well as substantial resource requirements and difficulties in recruiting sufficiently large and homogeneous cohorts from a highly pre-treated patient population. Consequently, indirect treatment comparisons (ITCs) play a critical role in evaluating the relative benefits of CAR-T cell therapies. However, ITCs are inherently susceptible to confounding, underscoring the importance of systematically identifying and appropriately adjusting for key prognostic factors, and treatment effect modifiers. <b>Materials & methods:</b> A systematic literature search was conducted in PubMed/MEDLINE, EMBASE and the Cochrane Central Register of Controlled Trials (CENTRAL) in November 2025. Database-specific search strategies using controlled vocabulary (MeSH and Emtree) were applied. Records were deduplicated prior to screening. Studies published in English or German were eligible. Two reviewers independently screened titles/abstracts and full texts using predefined criteria, with disagreements resolved by consensus. <b>Results:</b> A total of 27 publications met the inclusion criteria. Most studies used unanchored matching-adjusted indirect comparisons, followed by propensity score-based methods and network meta-analyses. The extent of covariate adjustment varied widely, ranging from no adjustment to extensive multivariable adjustment with up to 19 covariates. Commonly adjusted factors included demographics, disease severity, clinical status and treatment history. Efficacy outcomes most frequently assessed overall and progression-free survival and response rates, whereas safety outcomes were reported less consistently and were rarely covariate-adjusted, limiting comparative interpretation. Covariates were selected based on clinical expertise and/or literature review; however, no study provided a detailed description of the identification methodology. <b>Conclusion:</b> Although the selection of variables for adjustment frequently targeted recognized prognostic factors, the underlying processes lacked methodological transparency and were often constrained by data availability or undocumented expert opinion. Consequently, this resulted in substantial heterogeneity across studies. Notably, even fundamental covariates routinely required in health technology assessments, such as age, sex and disease severity, were inconsistently addressed, further limiting the comparability and robustness of the reported ITCs. To enhance the reliability and comparability of ITC results, standardized approaches for covariate identification and adjustment are urgently needed.</p>","PeriodicalId":15539,"journal":{"name":"Journal of comparative effectiveness research","volume":" ","pages":"e260033"},"PeriodicalIF":2.8,"publicationDate":"2026-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13329853/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148338618","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Tralokinumab as a cost-saving treatment option for adults and adolescents with moderate-to-severe atopic dermatitis enrolled in US health insurance plans: a budget impact analysis.","authors":"Reece Grindley, Linnea Houde, Aseel Bin Sawad, Sanjeev Balu, Shannon Schneider","doi":"10.57264/cer-2026-0042","DOIUrl":"10.57264/cer-2026-0042","url":null,"abstract":"<p><p><b>Background:</b> Atopic dermatitis (AD) is a chronic and burdensome condition that causes intense itching and painful skin lesions and affects around 10% of adults and adolescents across the US. Potent systemic treatments, such as tralokinumab, are needed to treat patients with moderate-to-severe disease who have experienced inadequate symptom control using topical therapies. Novel systemic treatments can not only provide effective relief for these patients but can also be cost saving. <b>Aim:</b> To evaluate the budgetary implications of tralokinumab as a treatment for moderate-to-severe AD in a hypothetical US commercial healthcare plan with 1 million (M) members. <b>Materials & methods:</b> A budget impact model was developed to estimate the difference in total systemic treatment costs between two scenarios: one in which dupilumab, lebrikizumab, nemolizumab, abrocitinib and upadacitinib are assumed to be the only treatments available, and one in which tralokinumab is assumed to be an additional option. The analysis took the perspective of a US commercial payer and estimated total treatment costs over a 3-year time horizon. Patients were distributed to treatments based on forecasted market share data and could switch from dupilumab to other systemic treatments in the model at any time. Switching rates were also informed using forecasting data. Adult patients receiving tralokinumab and adults or adolescents receiving lebrikizumab and nemolizumab could switch to a lower frequency administration schedule if they achieved clear or almost clear skin, reducing the number of doses received and consequently the treatment costs. Treatment costs were informed by 2025 wholesale acquisition costs. <b>Results:</b> Total costs when tralokinumab was not available were estimated to be $21.0 M, $27.7 M and $35.9 M in years 1-3, respectively. When tralokinumab was available, estimates were $20.6 M (Δ-0.5 M) in year 1, $26.6 M (Δ-1.1 M) in year 2 and $34.1 M (Δ-1.8 M) in year 3. Therefore, availability of tralokinumab led to cumulative cost savings of $3.4 M across all 3 years ($2.3 M in adults and $1.1 M in adolescents). Cumulative treatment costs per plan member at year 3 also reduced from $84.68 to $81.26 (Δ-3.42) due to tralokinumab. Lastly, cumulative per patient treatment costs across the 653 patients estimated to receive systematic therapy over the 3 years reduced from $129,794 to $124,556 when tralokinumab was available. <b>Conclusion:</b> Tralokinumab is a cost-saving therapy when used for the treatment of moderate-to-severe AD in both adult and adolescent populations, with cost savings driven by competitive skin clearance rates, low monthly treatment costs and flexible dosing options in adults (i.e., Q2W → Q4W).</p>","PeriodicalId":15539,"journal":{"name":"Journal of comparative effectiveness research","volume":" ","pages":"e260042"},"PeriodicalIF":2.8,"publicationDate":"2026-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13329891/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148205144","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Comparative efficacy and safety of olezarsen versus volanesorsen for familial chylomicronemia syndrome: a matching-adjusted indirect comparison.","authors":"Handrean Soran, Asia Sikora Kessler, Montserrat Vera-Llonch, Veronica J Alexander, Paul Serafini, Divya Pushkarna, Elisabete Rodrigues, Erik Stroes, Ulrike Schatz, Ursula Kassner, Zalmai Hakimi, Aletta Falk, Koo Wilson","doi":"10.57264/cer-2026-0069","DOIUrl":"10.57264/cer-2026-0069","url":null,"abstract":"<p><p><b>Background:</b> Familial chylomicronemia syndrome (FCS) is a rare genetic disorder characterized by severe hypertriglyceridemia causing recurrent acute pancreatitis (AP). Since FCS is a genetic deficiency in functional lipoprotein lipase, conventional triglyceride-lowering therapies are ineffective in this metabolic disorder. Apolipoprotein C-III (apoC-III) inhibitors, including volanesorsen and olezarsen, have emerged as targeted treatments for FCS. <b>Aim:</b> To compare the efficacy and safety of olezarsen 80 mg every four weeks (Q4W) versus volanesorsen 300 mg weekly (QW) in patients with FCS using an anchored matching-adjusted indirect comparison. <b>Materials & methods:</b> Individual patient data from the Balance trial of olezarsen (n = 45) were weighted to match baseline characteristics reported in the APPROACH trial of volanesorsen (n = 66). Outcomes included percent change in fasting triglycerides (TG) and apoC-III at 26 and 52 weeks, and risks of AP events and adverse events at 52 weeks. <b>Results:</b> At 52 weeks, mean differences in fasting TG and apoC-III were -27.4% (95% CI: -69.4, 14.5) and -21.3% (95% CI: -61.9, 19.3). Relative risks of AP, treatment-emergent adverse events, and serious adverse events were 0.23 (95% CI: 0.01, 5.02), 0.87 (95% CI: 0.66, 1.13) and 0.50 (95% CI: 0.08, 3.26) at week 52. The rate ratio for AP events per patient-year was 0.06 (95% CI: 0.003, 1.41). No comparisons were statistically significant. <b>Conclusion:</b> In this matching-adjusted indirect comparison, no statistically significant differences in outcomes were observed between olezarsen and volanesorsen in patients with FCS. These findings provide important comparative context in a setting where head-to-head evidence is unavailable.</p>","PeriodicalId":15539,"journal":{"name":"Journal of comparative effectiveness research","volume":" ","pages":"e260069"},"PeriodicalIF":2.8,"publicationDate":"2026-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13329855/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148277614","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Most-Favored-Nation pricing meets Joint Clinical Assessment: early evidence of compounding pressure on European drug launches.","authors":"Sreeram V Ramagopalan, Michael L Ryan","doi":"10.57264/cer-2026-0110","DOIUrl":"10.57264/cer-2026-0110","url":null,"abstract":"","PeriodicalId":15539,"journal":{"name":"Journal of comparative effectiveness research","volume":" ","pages":"e260110"},"PeriodicalIF":2.8,"publicationDate":"2026-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13329871/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148277542","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Healthcare resource utilization and costs in patients with multiple myeloma administered ciltacabtagene autoleucel in outpatient versus inpatient settings after one to three prior lines of therapy.","authors":"Murali Janakiram, Sabyasachi Ghosh, Victoria Alegria, Matthew Perciavalle, Bruno Emond, Jessica Maitland, Todd Bixby, Saurabh P Nagar, Zaina P Qureshi, Dimitra Rafailia Bakaloudi, Danai Dima","doi":"10.57264/cer-2026-0052","DOIUrl":"10.57264/cer-2026-0052","url":null,"abstract":"<p><p><b>Background:</b> Ciltacabtagene autoleucel (cilta-cel) was approved for patients with relapsed or refractory multiple myeloma who received 1-3 prior lines of therapy in April 2024. Although traditionally administered inpatient (IP), there is an increasing trend in outpatient (OP) cilta-cel administration. However, few studies have quantified the healthcare resource utilization (HCRU) and cost implications of OP versus IP administration in clinical practice. <b>Aim:</b> To compare HCRU and costs following OP versus IP administration of cilta-cel among patients with relapsed or refractory multiple myeloma after 1-3 prior lines of therapy. <b>Materials & methods:</b> This retrospective observational study used the Loopback Analytics electronic medical records database (28 February 2017 to 30 June 2025). We classified patients into OP or IP cohorts. All-cause and multiple myeloma-related HCRU and per-patient-per-month imputed costs were compared over 30 and 90 days post-infusion. <b>Results:</b> There were 99 patients included (OP: 37; IP: 62). In the first 30 days post-infusion, 40.5% of the OP cohort did not require IP admission. Compared with the IP cohort, the OP cohort had significantly lower all-cause IP days (adjusted incidence rate ratio: 0.31; p < 0.001) and significantly lower all-cause IP-related imputed costs (adjusted mean difference: -$39,786; p < 0.001). Results were consistent over the first 90 days post-infusion and for multiple myeloma related HCRU and costs. Overall, OP administration was associated with an estimated cost savings of approximately $40,000 and $53,000 per patient in the first 30 and 90 days post-infusion, respectively. <b>Conclusion:</b> OP administration of cilta-cel was associated with significantly lower IP resource utilization and imputed costs over the first 3 months post-infusion relative to IP administration, supporting the potential economic value and adoption of OP cilta-cel delivery.</p>","PeriodicalId":15539,"journal":{"name":"Journal of comparative effectiveness research","volume":" ","pages":"e260052"},"PeriodicalIF":2.8,"publicationDate":"2026-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13329856/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148345515","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Considerations for assessing the feasibility of network meta-analysis of seasonal vaccines.","authors":"Allie Cichewicz, Marissa Betts, Narcisa Mesaros, Heather Burnett","doi":"10.57264/cer-2026-0014","DOIUrl":"10.57264/cer-2026-0014","url":null,"abstract":"<p><p><b>Aim:</b> Network meta-analyses (NMAs) of seasonal vaccines face distinct challenges that can compromise the validity and relevance of findings. While established frameworks offer guidance for evaluating the feasibility of NMAs, they do not address factors specific to seasonal vaccines. This study aims to highlight unique methodological challenges related to conducting NMA feasibility assessments of seasonal vaccines. The considerations are framed to be compatible with existing guidance and recommendations for the conduct and reporting of NMAs. <b>Materials & methods:</b> We developed a set of key considerations that should be applied when assessing the feasibility and/or validity of NMAs comparing seasonal vaccines. The considerations were based on systematic reviews and critical appraisals of published NMAs of seasonal vaccines, hands-on experience performing feasibility assessments of seasonal vaccines, and input from consultations with vaccine experts. <b>Results:</b> Unique considerations for evaluating comparability across seasonal vaccine studies include: whether vaccines should be compared by platform, formulation, dose, and/or valence; the impact of seasonality, strain evolution and definitions of placebo/unvaccinated controls on network connectivity; target population characteristics including history and recency of prior vaccination and/or infection(s), and baseline infection/severe disease risk; antigenic match (i.e., the degree of concordance between vaccine composition and circulating viral strains), which directly influences effectiveness and outcome measurement approaches that consider time varying epidemiology and assay and measure discrepancy. Comprehensively integrating these elements into existing guidance frameworks ensures transparent assessment of the key assumptions underlying NMA (i.e., transitivity and homogeneity) within the context of unique study design and methodological features of seasonal vaccine studies. <b>Conclusion:</b> The concepts highlighted in this paper address important gaps in the feasibility assessment process for NMAs of seasonal vaccines, which are crucial for informing public health decisions and guiding vaccine policy and implementation.</p>","PeriodicalId":15539,"journal":{"name":"Journal of comparative effectiveness research","volume":" ","pages":"e260014"},"PeriodicalIF":2.8,"publicationDate":"2026-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13329890/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148345556","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Association of physical activity levels and estimated glomerular filtration rate with all-cause mortality: a 10-year cohort study.","authors":"Hang Jin, Lan Cui, Jiali Liu, Dan Wang, Xin Chen, Yu Qin, Yongqing Zhang, Quanyong Xiang","doi":"10.57264/cer-2025-0209","DOIUrl":"10.57264/cer-2025-0209","url":null,"abstract":"<p><p><b>Aim:</b> Many studies have demonstrated that physical inactivity and reduced renal function are associated with an increased risk of all-cause mortality. However, most of this evidence is derived from non-Chinese populations. This study aimed to investigate the association of physical activity (PA) with the risk of all-cause mortality among Chinese adults with and without impaired kidney function. <b>Materials & methods:</b> We conducted a prospective cohort study among a population in Jiangsu Province, China. Cox proportional hazards regression models were used to explore the associations of estimated glomerular filtration rate (eGFR) and PA with all-cause mortality, as well as to test for potential interactions between eGFR and PA. <b>Results:</b> A total of 6266 participants with complete data were included in the analysis, with a median age of 52 years and 44% being male. Of these participants, 1034 (16.5%) had an eGFR <60 ml/min/1.73 m². During a median follow-up 9.1 years (interquartile range [IQR]: 7.7-9.9), 196(3.1%) participants died. Participants with eGFR <60 ml/min/1.73 m² had a significantly higher risk of death (hazard ratio [HR] = 1.93; 95% confidence interval [CI]: 1.39-2.68) compared with eGFR ≥60 ml/min/1.73 m². A significant interaction was observed between PA and eGFR in relation to all-cause mortality risk (p for interaction = 0.004). Notably, participant with eGFR <60 ml/min/1.73 m² and low PA had a highest risk of all-cause mortality, compared with those with eGFR ≥60 ml/min/1.73 m² and high PA (HR: 4.06; 95% CI: 2.34-7.03). <b>Conclusion:</b> PA, a key lifestyle factor, is a potentially modifiable risk factor for both individuals with normal renal function and those with impaired kidney function. Consistent with existing literature, participants with decreased renal function exhibited a significantly higher risk of all-cause mortality. Notably, our analysis further revealed that the risk of all-cause mortality was the highest among participants with impaired renal function and low PA.</p>","PeriodicalId":15539,"journal":{"name":"Journal of comparative effectiveness research","volume":" ","pages":"e250209"},"PeriodicalIF":2.8,"publicationDate":"2026-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13329870/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148258526","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"R WE ready for reimbursement? A round-up of developments in real-world evidence relating to health technology assessment: part 26.","authors":"Paul Arora, Sreeram V Ramagopalan","doi":"10.57264/cer-2026-0074","DOIUrl":"10.57264/cer-2026-0074","url":null,"abstract":"<p><p>In this update, we review a framework for identifying and mitigating information bias in electronic health records and administrative claims data, highlighting practical recommendations for study design, variable definition, and statistical analysis. We also discuss a perspective on emerging privacy-preserving technologies - synthetic data and federated networks - that enable secure cross-border data access while maintaining patient privacy.</p>","PeriodicalId":15539,"journal":{"name":"Journal of comparative effectiveness research","volume":" ","pages":"e260074"},"PeriodicalIF":2.8,"publicationDate":"2026-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13329867/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147838612","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Access in all areas? A round-up of developments in market access and health technology assessment: first Joint Clinical Assessment report released.","authors":"Sreeram V Ramagopalan, Annie Jullien Pannelay","doi":"10.57264/cer-2026-0117","DOIUrl":"10.57264/cer-2026-0117","url":null,"abstract":"<p><p>The first Joint Clinical Assessment (JCA) report has been completed. In this update we examine what this inaugural report reveals in practice and draw out the implications for manufacturers.</p>","PeriodicalId":15539,"journal":{"name":"Journal of comparative effectiveness research","volume":" ","pages":"e260117"},"PeriodicalIF":2.8,"publicationDate":"2026-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13329894/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148264548","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Use of intracardiac echocardiography and three-dimensional mapping during catheter ablation for atrial fibrillation is associated with reduced complications: a retrospective analysis of United States Medicare Fee-For-Service Database.","authors":"Yiran Rong, Tom Wei, Kevin Corriveau, Rahul Khanna","doi":"10.57264/cer-2026-0037","DOIUrl":"10.57264/cer-2026-0037","url":null,"abstract":"<p><p><b>Aim:</b> This retrospective cohort study assessed differences in procedure-related complications and death among old patients with atrial fibrillation (AF) undergoing catheter ablation (CA) procedure with versus without use of intracardiac echocardiography (ICE) and advanced three-dimensional (3D) electroanatomical mapping. <b>Materials & methods:</b> Using the Medicare Database, a retrospective cohort of AF patients ≥65 years of age who underwent CA procedure were identified, and categorized into two cohorts: CA without ICE/3D mapping versus CA with ICE/3D mapping. Outcomes including a composite of complications (any), cardiac perforation, esophageal fistula and death, respectively, in the 30-day period post-CA were assessed. Inverse probability of treatment weighting method was used for covariate balancing. Cox regression models were performed to evaluate outcomes. <b>Results:</b> There were 35,490 patients in CA without ICE/3D mapping cohort and 170,762 in the CA with ICE/3D mapping cohort. Cox regression model revealed that patients who underwent CA without ICE/3D mapping use were ∼3.5-times more likely to have 30-day any complication versus those who had CA with ICE/3D mapping (7.3% vs 2.2%, log-rank test p < 0.001; hazard ratio: 3.507; 95% CI: 3.307-3.720, p < 0.001). The incidence of cardiac perforation (2.5% vs 0.1%, log-rank test p < 0.001), atrio-esophageal fistula (0.03% vs 0.01%, log-rank test p = 0.03) and death (1.6% vs 0.2%, log-rank test p < 0.001) were significantly higher among patients without ICE/3D mapping versus those who had CA with ICE/3D mapping. <b>Conclusion:</b> The absence of ICE and 3D mapping during CA procedures was associated with significantly increased risk of complications and death among Medicare eligible patients with AF.</p>","PeriodicalId":15539,"journal":{"name":"Journal of comparative effectiveness research","volume":" ","pages":"e260037"},"PeriodicalIF":2.8,"publicationDate":"2026-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13329872/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148295189","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}