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The superiority of transcatheter (TAVR) over surgical aortic valve replacement (SAVR) for severe aortic stenosis (AS) has not been fully demonstrated in a real-world setting. This prospective study included 5706 AS patients who underwent SAVR from 2010 to 2012 and 2989 AS patients who underwent TAVR from 2017 to 2018 from the prospective multicenter observational studies OBSERVANT I and II. Early adverse events as well as all-cause mortality, major adverse cardiac and cerebrovascular events (MACCEs), and hospital readmission due to heart failure at 1-year were investigated. Among 1008 propensity score matched pairs, TAVR was associated with significantly lower 30-day mortality (1.8 vs. 3.5%, p = 0.020), stroke (0.8 vs. 2.3%, p = 0.005), and acute kidney injury (0.6 vs. 8.2%, p < 0.001) compared to SAVR. Moderate-to-severe paravalvular regurgitation (5.9 vs. 2.0%, p < 0.001) and permanent pacemaker implantation (13.8 vs. 3.3%, p < 0.001) were more frequent after TAVR. At 1-year, TAVR was associated with lower risk of all-cause mortality (7.9 vs. 11.5%, p = 0.006), MACCE (12.0 vs. 15.8%, p = 0.011), readmission due to heart failure (10.8 vs. 15.9%, p < 0.001), and stroke (3.2 vs. 5.1%, p = 0.033) compared to SAVR. TAVR reduced 1-year mortality in the subgroups of patients aged 80 years or older (HR 0.49, 95% CI 0.33–0.71), in females (HR 0.57, 0.38–0.85), and among patients with EuroSCORE II ≥ 4.0% (HR 0.48, 95% CI 0.32–0.71). In a real-world setting, TAVR using new-generation devices was associated with lower rates of adverse events up to 1-year follow-up compared to SAVR.

Introduction: Data on the early and late outcome following transcatheter aortic valve implantation (TAVI) and surgical aortic valve replacement (SAVR) in obese patients are limited. We investigated whether TAVI may be superior to SAVR in obese patients. Material and methods: Obese patients (body mass index ≥ 30 kg/m²) who underwent either SAVR or TAVI were identified from the nationwide OBSERVANT registry, and their in-hospital and long-term outcomes were analysed. Propensity score matching was employed to identify two cohorts with similar baseline characteristics. Results: The propensity score matching provided 142 pairs balanced in terms of baseline risk factors. In-hospital and 30-day mortality did not differ between SAVR and TAVI obese patients (4.6% vs. 3.3%, p = 0.56, and 5.2% vs. 3.2%, p = 0.41, respectively). Obese SAVR patients experienced a higher rate of renal failure (12.4% vs. 3.6%, p = 0.0105) and blood transfusion requirement (60.3% vs. 25.7%, p < 0.0001) in comparison with TAVI patients. A higher rate of permanent pacemaker implantation (14.4% vs. 3.6%, p = 0.0018), and major vascular injuries (7.4% vs. 0%, p = 0.0044) occurred in the TAVI group. Five-year survival was higher in the SAVR group compared to the TAVI patient cohort (p = 0.0046), with survival estimates at 1, 3 and 5 years of 88.0%, 80.3%, 71.8% for patients undergoing SAVR, and 85.2%, 69.0%, 52.8% for those subjected to TAVI procedures. Conclusions: In obese patients, both SAVR and TAVI are valid treatment options, although in the long term SAVR exhibited higher survival rates.

Background: The OBSERVANT study (Observational Study of Effectiveness of SAVR–TAVI Procedures for Severe Aortic Stenosis Treatment) showed that mortality at 1 year is similar after transfemoral transcatheter aortic valve replacement (TAVR) or surgical aortic valve replacement (SAVR) for real-world propensity-matched patients with aortic stenosis at low and intermediate risk. We report the 5-year outcomes of the Italian OBSERVANT study. Methods and Results: The unadjusted enrolled population (N=7618) between December 2010 and June 2012 included 5707 patients on SAVR and 1911 patients on TAVR. The propensity score method was applied to select 2 groups with similar baseline characteristics. All outcomes were adjudicated through a linkage with administrative databases. The primary end points of this analysis were death from any cause and major adverse cardiac and cerebrovascular events at 5 years. The matched population had a total of 1300 patients (650 per group). The propensity score method generated a low and intermediate-risk population (mean logistic EuroSCORE 2: 5.1±6.2% versus 4.9±5.1%, SAVR versus transfemoral TAVR; P=0.485). At 5 years, the rate of 5 death from any cause was 35.8% in the surgical group and 48.3% in the transcatheter group (hazard ratio, 1.38; 95% CI, 1.12–1.69; P=0.002). Similarly, TAVR was associated with an increased risk of major adverse cardiac and cerebrovascular events as compared with SAVR (42.5% versus 54.0%; hazard ratio, 1.35; 95% CI, 1.11–1.63; P=0.003). The cumulative incidence of cerebrovascular events, myocardial infarction, and coronary revascularization were similar in the study groups at 5 years. Conclusions: The present results suggest that at 5 years, in a real-world population with severe aortic stenosis and at low and intermediate risk, suggest that SAVR is associated in with lower mortality and major adverse cardiac and cerebrovascular events rates than transfemoral TAVR performed using first-generation devices. T

Background: To assess clinical outcomes of patients with concomitant severe aortic stenosis (AS) and coronary artery disease (CAD) who underwent transcatheter aortic valve implantation (TAVI) and percutaneous coronary intervention (PCI) or surgical aortic valve replacement (SAVR) and coronary artery bypass grafting (CABG). Methods: Data were extracted from the multicenter OBSERVANT study. For the purposes of the present analysis, we included only patients with established stable CAD meeting any of the following inclusion criteria: 1) TAVI patients with CAD undergoing staged PCI or TAVI and PCI in the same session; 2) SAVR patients undergoing combined SAVR and CABG in the same session. Results: After propensity-score matching, a total of 472 patients (236 per group) were identified. Among TAVI patients, PCI was performed prior to the procedure in 217 patients (92.0%), whereas concomitant TAVI and PCI were performed in 19 patients (8.0%). At 3-year, there was no difference in survival between the two groups (KM estimate of freedom from death for SAVR and TAVI patients of 0.742 and 0.650, respectively; log-rank p-value of 0.105). The rate of MACCE was comparable between the two groups (KM estimate of freedom from MACCE for SAVR and TAVI patients of 0.683 and 0.582, respectively; log-rank p-value of 0.115). Conclusions: In patients with associated severe AS and CAD, percutaneous treatment (TAVR and staged or concomitant PCI) was comparable to surgical treatment (SAVR and concomitant CABG) with respect to the early and mid-term risk of death from any cause, myocardial infarction, stroke and unplanned revascularization.

Objectives: We compared the outcome of anaemic patients undergoing transcatheter (TAVI) and surgical aortic valve replacement (SAVR) for severe aortic valve stenosis. Methods: Anaemic patients (haemoglobin <13.0 g/dL in men and <12.0 g/dL in women) undergoing TAVI and SAVR from the OBSERVANT study were the subjects of this analysis. Results: Preoperative anaemia was an independent predictor of 3-year mortality after either TAVI (HR 1.37, 95% CI 1.12–1.68) and SAVR (HR 1.63, 95% CI 1.37–1.99). Propensity score matching resulted in 302 pairs with similar characteristics. Patients undergoing SAVR had similar 30-d mortality (3.6% versus 3.3%, p = .81) and stroke (1.3% versus 2.0%, p = .53) compared with TAVI. The rates of pacemaker implantation (18.6% versus 3.0%, p < .001), major vascular damage (5.7% versus 0.4%, p < .001) and mild-to-severe paravalvular regurgitation (47.4% versus 9.3%, p < .001) were higher after TAVI, whereas acute kidney injury (50.7% versus 27.9%, p < .001) and blood transfusion (70.0% versus 38.6%, p < .001) were more frequent after SAVR. At 3-year, survival was 74.0% after SAVR and 66.3% after TAVI, respectively (p = .065), and freedom from MACCE was 67.6% after SAVR and 58.7% after TAVI, respectively (p = .049). Conclusions: These results suggest that TAVI is not superior to SAVR in patients with anaemia.

Objectives: The aim of this study was to assess the impact of frailty on the outcome after coronary artery bypass grafting (CABG) and whether it may improve the predictive ability of European System for Cardiac Operative Risk Evaluation (EuroSCORE II). Methods: The Clinical Frailty Scale (CFS) was assessed preoperatively in patients undergoing isolated CABG from the multicentre E-CABG registry, and patients were stratified into 3 classes: scores 1–2, scores 3–4 and scores 5–7. Results: Of the 6156 patients enrolled, 39.2% had CFS scores 1–2, 57.6% scores 3–4, and 3.2% scores 5–7. Logistic regression adjusted for multiple covariates showed that the CFS was an independent predictor of hospital/30-day mortality [CFS scores 3–4, odds ratio (OR) 3.95, 95% confidence interval (CI) 2.19–7.14; CFS scores 5–7, OR 5.90, 95% CI 2.67–13.05] and resulted in an Integrated Improvement Index of 1.3 (P < 0.001) and a Net Reclassification Index of 55.6 (P < 0.001) for prediction of hospital/30-day mortality. Adding the CFS classes to EuroSCORE II resulted in an Integrated Improvement Index of 0.9 (P < 0.001) and Net Reclassification Index of 59.6 (P < 0.001) for prediction of hospital/30-day mortality with a significantly larger area under the receiver operating characteristics curve (0.809 vs 0.781, P = 0.028). The CFS was an independent predictor of mid-term mortality [CFS scores 3–4, hazard ratio (HR) 2.05, 95% CI 1.43–2.85; CFS scores 5–7, HR 3.05, 95% CI 1.83–5.06]. Conclusions: The CFS predicted early- and mid-term mortality in patients undergoing isolated CABG. Further studies are needed to evaluate whether frailty may improve the estimation of the operative risk of patients undergoing adult cardiac surgery.

There is a paucity of prospective and controlled data on the comparative effectiveness of transcatheter aortic valve replacement (TAVR) versus surgical aortic valve replacement (SAVR) in a real-world setting.