PURPOSE:In the United States, the Food and Drug Administration has provided guidance on the contexts in which real-world evidence (RWE) can be used to support regulatory decisions for medical devices. METHODS:In this paper, we review different sources of real-world data (RWD) for medical devices used in surgical procedures and how to optimize the design and analysis features of RWD studies to maximize the strength of RWE. The design and analysis of a study are critical to ensuring that the RWE generated from the RWD can ultimately be used to support a regulatory decision or fulfill a commitment for a medical device. We consider several topics relevant to medical device RWE in our review: misclassification and measurement error, causal inference, and incomplete follow-up. RESULTS:Some key challenges include indication and outcome misclassification in non‑registry data, tenuous assumptions of single‑arm designs, device‑ and surgeon‑level confounding in comparative studies, and potentially informative loss to follow‑up from censoring (e.g., insurance termination). CONCLUSION:The review is intended as a guide to researchers and regulators interested in generating or evaluating medical device RWE for regulatory purposes.

Hospital billing data can provide safety and effectiveness insights on medical devices. However, hospital data follow patients longitudinally in the same hospital only. Comparison of outcome risks (e.g., readmission and revision) in hospital versus claims data is important to understand any potential loss of data capture when evaluating outcomes for devices using hospital data. The objective of this study was to evaluate accuracy of hospital databases for long-term patient follow-up by type of endpoint using cervical fusion surgery as an example. The study included 150,459 and 62,752 patients in the claims and hospital databases, respectively. Cohort balancing was performed using propensity score methods. Risks of readmission at 90 and revision at 365-days post-surgery were 11.9

Background Oral anticoagulation (OAC) is recommended for ≥3 months post catheter ablation (CA) for atrial fibrillation (AF) and indefinitely in higher risk patients. Current practice and associated predictors are unknown. Objective Report current OAC practice among patients after AF ablation and identify features predictive of OAC therapy post ablation. Methods Patients with AF who underwent CA Jan 1,2017, to Oct 1, 2023, were identified from Optum’s Clinformatics® Data Mart and stratified by CHA2DS2-VASc score into 4 groups. OAC treatment was assessed at 30- and 365-days post CA. Automated machine learning was used to predict OAC use within 1-year after CA based on demographic and clinical information; area under the receiver operating curve (AUROC) was reported. Results We included 65,020 patients (mean age 69; 39% female) with mean CHA2DS2-VASc score 4.16±2.03. OAC continuation fell steadily over the year after CA especially among lower risk patients. In approximately 10-20% of patients, OAC was not prescribed at the time of ablation or after across all risk groups. The AUROC for the total AF population was 0.607 (95% confidence interval [CI] 0.587 - 0.614). Main predictors for OAC discontinuation at 1-year were lower CHA2DS2-VASc baseline score (w, 0.033), left atrial appendage occlusion (LAAO) post-CA (w, 0.018), and bleeding event in the follow-up period (w, 0.010), and. Conclusion Discordant with guidelines recommendations, OAC discontinuation was common among patients with AF and at least moderate stroke risk. Stroke risk, LAAO, and bleeding experience were the strongest determinants of OAC discontinuation but did not explain much of the discontinuation.

Introduction: Catheter ablation (CA) is a treatment strategy for patients with atrial fibrillation (AF). The 2023 ACC/AHA/ACCP/HRS guidelines recommend oral anticoagulant (OAC) therapy for at least 3 months post-CA with long-term continuation based on individual stroke risk. Research Question: Are US patients with AF after CA treated with guideline-concordant anticoagulation? Methods: The Optum Clinformatics DataMart Date of Death claims data were used for this study, which included patients aged ≥18 years with AF diagnosis who underwent CA (with first such ablation classified as ‘index ablation event’) from Jan 2017 until Oct 2023. Patients were excluded if they: 1) had less than 6 months continuous enrollment prior to the index ablation procedure; 2) underwent a left atrial appendage occlusion procedure prior to the index date. Treatment persistence for OAC in the 1-year period post-CA was assessed using descriptive statistics, including Kaplan-Meier plots and estimates. Automated machine learning was used to predict OAC use within 1-year after CA. Patients’ demographics, baseline medical conditions and clinical events prior to drug discontinuation ( e.g. , bleeding, repeated ablation, cardioversion) were included as factors of interest in the model. Area under the receiver operator curve (AUROC) was calculated, as well as importance score (w), i.e. , contribution to AUROC, for each factor. Results: 65,020 patients (mean age 69, standard deviation 10; 39% female) underwent CA in the study period (89.7% with CHA 2 DS 2 -VASc score ≥ 2 at index date). Of these patients, ~ 85% continued OACs for 3 months but only 54.9% at 1 year (Figure 1). The AUROC for the total AF population was 0.685 (95% CI: 0.671 - 0.699). Main predictors for OAC discontinuation at 1-year were CHA 2 DS 2 -VASc baseline score (w, 0.034), bleeding incidence in the follow-up period (w, 0.026), and left atrial appendage occlusion post-CA (w, 0.020). The predictors of OAC discontinuation were similar for paroxysmal (AUROC, 0.689 [95%CI 0.666-0.713]) vs persistent (AUROC, 0.668 [0.664-0.701]) AF. Conclusion: Although guidelines recommend continuing OAC after ablation if CHA 2 DS 2 -VASc score ≥ 2, discontinuation was common in US patients with AF. Machine learning developed a predictive model with reasonably good performance, identifying CHA 2 DS 2 -VASc score as the strongest predictor of guideline concordant OAC therapy in the post ablation period.

Introduction: Catheter ablation is an effective strategy for the maintenance of sinus rhythm and enhancement of quality of life in patients with atrial fibrillation (AF). Oral anticoagulants (OAC) are recommended for at least 3 months post-ablation and indefinitely in patients with CHA 2 DS 2 -VASc score ≥2. Research Question: What is the pattern of OAC use from the time of ablation to one year after ablation with respect to CHA 2 DS 2 -VASc score? Methods: Patients with AF who underwent ablation (index date) from Jan 2017 to Oct 2023 were identified from Optum Clinformatics EDM–DoD. The cohort was divided into three groups: CHA 2 DS 2 -VASc 0 (low risk), 1 (intermediate risk), and ≥ 2 (high risk). Additionally, a subgroup with score ≥ 4 (very high-risk) was assessed. Treatment with OACs ( i.e. , direct oral anticoagulants or vitamin K antagonists) was assessed within the 30-day window following the ablation and at 1-year. Results: Patients with CHA 2 DS 2 -VASc scores 0, 1, and ≥ 2 accounted for 2.8%, 7.5%, and 89.7% of the total population, respectively, with the ≥ 4 subgroup accounting for 61.6% of the total. The mean (SD) age was 52 (9), 58 (9), 70 (8), and 72 (7) years with females accounting for 0%, 14%, 42%, and 48% respectively. Many medical conditions were prevalent including hypertension (86%), obesity (45%), heart failure (44%), sleep apnea (41%), chronic kidney disease (25%) and diabetes (21%). For the low-risk group, OAC discontinuation ranged 66.9 to-78.6% at 1-year, and OAC continuation decreased by ~ 4% from 13.5% to 9.3% between 2017 and 2023. For patients in the intermediate risk group, OAC discontinuation was stable (~ 60%) and the continued use of OAC in the 1-year period increased by ~ 3% from 20.1% to 23.5%. For patients in the high-risk group, OAC discontinuation decreased by ~ 2% from 28.6% to 26.5% and the continued use of OAC increased by ~ 6% from 45.2% to 51.4%. For patients in the very high-risk group, OAC discontinuation minimally decreased, and OAC continuation increased by ~5% from 46.3% to 52%. In a stable minority of patients (~10-20%) across all risk groups, OAC was not used at the time of ablation or after. (Figure 1) Conclusion: Patterns of OAC treatment following AF ablation were variable across CHA 2 DS 2 -VASc score subgroups. The discordance between guideline recommendations and clinical practice with respect to post-AF ablation OAC use may have an important impact on cardiovascular outcomes.

Background:The use of surgical staplers for lung resection is widespread; however, determining the optimal surgical stapler remains a challenge. This study compared clinical and economic outcomes of the ECHELON™ 3000 Stapler (ECH3000) against its previous generation ECHELON™+ Stapler (ECH+) among patients undergoing lung resection. Methods:This was a retrospective, multi-institutional, comparative cohort study among patients undergoing lung resection using ECH3000 or ECH+ between April 1, 2022 and September 30, 2023 in the Premier Healthcare Database (PHD). The primary outcome was 30-day prolonged air leak (PAL). Secondary outcomes included 30-day bleeding-related complications and all-cause inpatient readmission, and index admission total hospital costs, length of stay (LOS), discharge status, and mortality. Covariate balancing propensity score (CBPS) weighting was used to balance baseline characteristics between groups. The difference in the cumulative incidence (binary outcomes) and mean (continuous outcomes) of study outcomes was calculated using covariate-balanced data. For the primary outcome, the non-inferiority in the difference in the cumulative incidence of 30-day PAL between groups was evaluated using a prespecified non-inferiority margin of 10%. Results:A total of 910 (ECH3000: 277; ECH+: 633) patients met the study eligibility criteria. The cumulative incidences of 30-day PAL were comparable between ECH3000 vs. ECH+ {13.7% vs. 13.0%; difference =0.7% [two-sided 95% confidence interval (CI): -4.6%, 5.9%]}. Since the upper bound of the 95% CI for the risk difference in 30-day PAL between groups (5.9%) was significantly lower than the prespecified non-inferiority margin of 10% (P value<0.001), the primary outcome was met. A lower cumulative incidence of 30-day bleeding-related complications was observed among patients using ECH3000 vs. ECH+ [9.4% vs. 16.4%; difference =-7.0% (95% CI: -12.2%, -1.8%)]. There were no significant differences between groups for other secondary outcomes. Conclusions:Among patients undergoing lung resection, ECH3000 had a comparable cumulative incidence of 30-day PAL and a lower cumulative incidence of bleeding-related complications compared to ECH+.

Introduction: ECHELON™ 3000 Staplers (ECH3000), designed to give surgeons better access and control, have demonstrated improved performance in benchtop testing; however, no prior research has evaluated their performance in clinical settings. This study compared clinical outcomes among patients undergoing lung resection using ECH3000 vs. ECHELON™+ Staplers (ECH+) in routine clinical practice. Methods: This retrospective comparative cohort study identified patients aged ≥18 years who underwent lung resection using either ECH3000 or ECH+ between April 1, 2022 to September 30, 2023 in the Premier Healthcare Database, one of the most comprehensive large multi-institutional electronic healthcare databases in the United States. The primary endpoint was prolonged air leak; and the secondary endpoint was bleeding-related complications within 30 days. Covariate balancing propensity score (CBPS) weighting was applied to balance the distribution of baseline characteristics between study groups. The difference in the cumulative incidence of primary and secondary endpoints between study groups was calculated. Variance was estimated using a non-parametric bootstrap and 95% confidence intervals (CI) were constructed. The non-inferiority in the difference of the cumulative incidences of prolonged air leak (primary endpoint) was evaluated using a non-inferiority margin of 10% at a one-sided significance level of 2.5%. Results: A total of 910 (ECH3000: 277; ECH+: 633) patients met the study eligibility criteria. Adequate balance was achieved across all covariates after CBPS weighting (maximum absolute standardized difference = 0.001). For the primary endpoint, the covariate-balanced cumulative incidences of prolonged air leak in the ECH3000 vs. ECH+ groups were 13.72% vs. 13.04% corresponding to a difference in the cumulative incidences of 0.68% (95% CI: -4.58%, 5.93%). The upper bound of the two-sided 95% CI for the difference in the cumulative incidences of prolonged air leak (5.93%) was significantly lower than the prespecified non-inferiority margin of 10% (p-value compared to the non-inferiority margin of 10%: 0.0003). Therefore, ECH3000 was non-inferior to ECH+ in terms of prolonged air leak. For the secondary endpoint, the covariate-balanced cumulative incidence of bleeding-related complications within 30 days was lower among patients undergoing lung resection using ECH3000 as compared to ECH+ (9.39% vs. 16.36%; difference = -6.97% [95% CI: -12.18%, -1.77%]). Conclusions: ECHELON™ 3000 Staplers were non-inferior to ECHELON™+ Staplers in terms of prolonged air leak and had a lower cumulative incidence of bleeding-related complications within 30 days among patients undergoing lung resection.