Background Prediction of operative risk in patients with aortic stenosis (AS) undergoing surgical aortic valve replacement (SAVR) or transcatheter aortic valve implantation (TAVI) remains a challenge, particularly in high-risk patients. The EuroSCORE II is now commonly used to improve risk prediction. Large analyses from administrative database have provided opportunities for conducting health research in the field of structural heart disease interventions but may have a lack of granularity and do not routinely include EuroSCORE II, which may result in a risk of uncontrolled biases. We sought to approximate the EuroSCORE II using only administrative claims data to enable the operative risk to be assessed without clinical or paraclinical performance measures. Methods Based on the administrative hospital-discharge database, we collected information for all patients with AS treated with SAVR or TAVI between 2010 and 2019 in France. A total of 78,085 SAVR and 60,821 patients with AS treated with transcatheter aortic valve replacement (TAVR) were found in the database. For each patient, the EuroSCORE II was estimated using the formulas available at the EuroSCORE website. Age, gender, extracardiac arteriopathy, poor mobility, previous cardiac surgery, chronic lung disease, active endocarditis, diabetes on insulin, recent MI, dialysis are items available in the PMSI database using the ICD-10 or CCAM codes. For renal impairment, NYHA class, LVEF, pulmonary hypertension, “critical preoperative state” and urgent intervention, different proxies were built based on ICD-10 codes likely to represent increasing severity of these items. Results In the cohort of patients with SAVR, mean estimated EuroSCORE II was 3.3±1.1 while all-cause death at day 30 after SAVR was 3.8%. In the cohort of patients with TAVI, mean estimated EuroSCORE II was 3.8±1.0 while all-cause death at day 30 after TAVI was 5.5%. In the whole cohort, the area under the curve (AUC) of the estimated EuroSCORE II for predicting the risk of all-cause death at day 30 was 0.72 (95% CI 0.71–0.73) and was higher in patients treated with SAVR (AUC 0.76, 95% CI 0.75–0.77) than in those treated with TAVI (AUC 0.67, 95% CI 0.65–0.68, p<0.00001 for DeLong test). The observed versus predicted risks of all-cause death at day 30 post-TAVI OR SAVR within risk deciles are shown in Figure 1. Calibration of the prediction score was satisfying across the 10 deciles and a predicted 30-day mortality rate of approximately 15%. Conclusions Claims data alone can be used to identify individuals with AS at operative risk when they are considered for SAVR or TAVI. The Claims-based EuroSCORE II might be used in research with large datasets for confounding adjustment or risk prediction. It provides hospitals and health systems with a low-cost, systematic way to identify a group of patients who are at greater risk of adverse outcomes with these interventions and for whom a more specific approach might be useful. Figure 1 Funding Acknowledgement Type of funding source: None
Background The incidence of conduction abnormalities requiring permanent pacemaker implantation (PPI) after transcatheter aortic valve replacement (TAVR) with different devices available in recent years remains a matter of debate. Methods Based on the administrative hospital-discharge database, we collected information for all patients treated with TAVR between 2010 and 2019 in France. We compared the incidence of PPI after TAVR according to the type and generation of valve implanted. Results A total of 49,201 patients with aortic stenosis treated with transcatheter aortic valve replacement (TAVR) using the balloon-expandable (BE) Edwards SAPIEN valve or the self-expanding (SE) Medtronic CoreValve were found in the database. Patients treated with early BE or SE valves had higher Charlson comorbidity and frailty indexes than those treated with later BE or SE valves, and slightly higher EuroSCORE II. Patients treated with SE valves had higher rates of previous pacemaker or defibrillator than those treated with BE valves. Mean (SD) follow-up was 1.2 (1.5 years) (median [interquartile range] 0.6 [0.1–2.0] years). PPI after the procedure was reported in 13,289 patients, among whom 11,010 (22.4%) had implantation during the first 30 days (figure 1). In multivariable analysis, using early BE TAVR as reference, adjusted OR (95% CI) for PPI during the first 30 days was 0.88 (0.81–0.95) for latest BE TAVR, 1.40 (1.27–1.55) for early SE TAVR and 1.17 (1.07–1.27) for latest SE TAVR. Compared to early BE TAVR, adjusted HR for PPI during the whole follow-up was 1.01 (0.95–1.08) for latest BE TAVR, 1.30 (1.21–1.40) for early SE TAVR and 1.25 (1.18–1.34) for latest SE TAVR. Conclusion In patients with aortic stenosis treated with TAVR, our systematic analysis at a nationwide level found higher rates of PPI than previously reported. BE technology was independently associated with lower incidence rates of PPI both at the acute and chronic phases than SE technology. However, this was less apparent than previously reported in this large analysis of unselected patients seen in “real life” practice. Recent generations of TAVR were not independently associated with different rates of PPI than early generations during the overall follow-up. Funding Acknowledgement Type of funding source: None
Funding Acknowledgements Type of funding sources: None. Introduction / Background Leadless ventricular permanent pacemakers (leadless VVI, LPM) were designed to reduce lead-related complications of conventional VVI pacemakers (CPM). Purpose The aim of our study was to assess and compare real-life clinical outcomes within the first 30 days and during a mid-term follow-up with the two techniques at a nationwide level. Methods This French longitudinal cohort study was based on the national hospitalization database covering hospital care from for the entire population. All adults (age ≥18 years) hospitalized in French hospitals From January 1, 2017 to September 1, 2020, who underwent a first LPM or CPM implantation were included. Results Of 42,315 patients included in the cohort, 40,828 patients (96%) had a CPM and 1,487 had a LPM. Using propensity score, 1,344 patients with CPM were adequately matched in a 1:1 fashion with LPM patients. Clinical outcomes at day 30 In the unmatched population, within the 30 days after implantation, patients with LPM had a lower rate of all-cause mortality (OR: 0.635, 95%CI: 0.527-0.765, p <0.0001) and from a cardiovascular cause (OR: 0.568, 95%CI: 0.405-0.797, p = 0.001). They also had lower rates of major bleeding and need for transfusion. There was no significant difference between groups regarding tamponade, pneumothorax or hemothorax. In the matched population, LPM implantation was still significantly associated with a lower rate of all-cause death (OR: 0.583, 95%CI: 0.456-0.744, p < 0.0001), cardiovascular death (OR: 0.413, 95%CI: 0.271-0.629, p < 0.0001) or transfusion (OR: 0.481, 95%CI: 0.296-0.780, p < 0.0001). However, tamponade, pneumothorax or hemothorax and major bleeding were not significantly different between the two groups. Clinical outcomes during mid-term follow-up In the unmatched patients, mean follow-up was 8.6 ± 10.5 months. Annual incidence of all-cause death was high in both groups, and significantly higher in the LPM group than in CPM group (31%/year vs. 20%/year, p < 0.0001) with a HR of 1.519 (95%CI: 1.296-1.780). Cardiovascular death was not significantly different between groups. Infective endocarditis was higher in the LPM group than in the CPM group with a HR of 2.108 (95%CI: 1.119-3.973). In the matched patients, mean follow-up was 6.2 ± 8.7 months. All-cause death, cardiovascular death and infective endocarditis were not significantly different between groups. Conclusion Patients treated with leadless VVI pacemakers had better clinical outcomes in the first month compared to the patients treated with conventional VVI pacing. During a mid-term follow-up, risk of all-cause death, cardiovascular death and endocarditis in patients treated with leadless VVI pacemaker was not statistically different after propensity score matching.
Funding Acknowledgements Type of funding sources: None. Introduction / Background Subcutaneous implantable cardioverter–defibrillators (S-ICD) was designed to avoid complications of single-chamber transvenous implantable cardioverter-defibrillators (VVI ICD) by using an entirely extra-thoracic placement. Purpose Our objective was to compare outcomes following first VVI ICD or S-ICD implantation in an exhaustive nationwide matched cohort. Methods This French longitudinal cohort study was based on the national hospitalization database covering hospital care from for the entire population. All adults (age ≥18 years) hospitalized in French hospitals From January 1, 2010 to September 1, 2020, who underwent a VVI ICD or S-ICD implantation were included. Patients with a previous pacemaker or ICD or with a history of infective endocarditis were excluded. Multivariable analyses for clinical outcomes during the whole follow-up in the groups of interests were performed using a Cox model with all baseline characteristics and reporting hazard ratio. Owing to the non-randomized nature of the study, and considering for significant differences in baseline characteristics, propensity-score matching was also used to control for potential confounders of the treatment outcome relationship. Results 21,667 patients were included in the cohort, 19,493 patients had a transvenous VVI ICD and 2,174 had a subcutaneous ICD. Mean age was 61.2 ± 13.2 years in the VVI ICD group and 52.3 ± 17.5 years in the S-ICD goup. Coronary artery disease was present in 71.6% of patients with a VVI ICD and 48.2% of patients with a S-ICD. Mean follow-up was 28.8 ± 31.8 months. S-ICD patients had a significant higher rate of all-cause death (HR: 1.684, 95%CI: 1.309-2.165, p < 0.001). There were no significant differences in cardiovascular death (HR: 1.092, 95%CI: 0.697-1.711, p = 0.70) and infective endocarditis (HR: 0.354, 95%CI: 0.067-1.433, p = 0.15) between the two groups Using propensity score, 1,582 patients with VVI ICD were matched 1:1 with S-ICD patients. Mean follow-up was 4.5 ± 7.2 months. In the matched analysis, there were no significant differences in all-cause death (HR: 1.090, 95%CI: 0.728-1.633, p = 0.68) and cardiovascular death (HR: 1.167, 95%CI: 0.603-2.260, p = 0.65) between the two groups. A trend toward a lower risk of infective endocarditis in the S-ICD group was also observed without reaching significance (HR : 0.219, 95%CI: 0.047-1.017, p = 0.053). A sensitivity analysis in patients with coronary artery disease in the matched cohort was performed. Same trends were observed without significant differences in all-cause death and cardiovascular death. Conclusion Our nationwide study highlighted a higher risk of all-cause death in patients treated with subcutaneous which however was not statistically significant after propensity score matching. No differences regarding cardiovascular mortality was found. An interesting trend toward diminution of infective endocarditis was also observed without reaching significancy.
Background Conduction abnormalities leading to permanent pacemaker (PPM) implantation are common complications following transcatheter aortic valve replacement (TAVR). Whether PPM implantation placement is associated with adverse outcomes is unclear. The purpose of this study was to evaluate the incidence, predictors, and clinical outcomes of PPI following TAVR. Methods Based on the administrative hospital-discharge database, we collected information for all patients treated with TAVR between 2010 and 2019 in France. Results A total of 49,201 patients with aortic stenosis treated with transcatheter aortic valve replacement (TAVR) using the balloon-expandable (BE) Edwards SAPIEN valve or the self-expanding (SE) Medtronic CoreValve were found in the database. Among them, 10,019 (20.4%) had prior PPM implantation, including 476 (4.8%) treated with cardiac resynchronization therapy (CRT). New PPM implantation was required within 30 days of TAVR in 11,010 patients (22.4%), which varied among those receiving self-expanding valves (24.7%) versus balloon-expanding valves (20.9%). There were 349/10,010 patients (3.1%) treated with cardiac resynchronization therapy (CRT) within 30 days following TAVR. In a multivariable analysis comprising 38 variables (including among others underlying conduction disorders, Euroscore 2, Charlson comorbidity index, frailty score and type of implanted valve), prior PPM implantation was associated with an increased risk of all-cause death (adjusted hazard ratio [HR]: 1.10 95% CI 1.04–1.16). New PPM implantation was associated with even higher risk of mortality (adjusted HR: 1.21 95% CI 1.15–1.28). By contrast, previous CRT was associated with a lower risk of death during follow-up (adjusted HR: 0.78 95% CI 0.63–0.96), while PPM with CRT within 30 days of TAVR was not associated with a different risk of death (adjusted HR: 1.00 95% CI 0.80–1.24). Prior PPM and new PPM implantation were also associated with an increased risk of rehospitalization for heart failure (adjusted HR: 1.26 95% CI 1.19–1.32 and 1.18 95% CI 1.12–1.24, respectively). Previous CRT was associated with a non-significant lower risk of rehospitalization for heart failure (adjusted HR: 0.92 95% CI 0.77–1.09). Conclusions Both previous PPM and early PPM implantation following TAVR are commonly seen in patients treated with TAVR, and they are associated with a higher risk of death and rehospitalisation for heart failure when compared to patients with no PPM. The fact that CRT when implanted before TAVR was associated with a better survival may deserve consideration when elaborating future optimal approaches for management of conduction disturbances in patients treated with TAVR. Funding Acknowledgement Type of funding source: None
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