595 Impact of age on outcomes in a large multicentre low-to-intermediate risk TAVI population: in and out the age cut-off from ESC 2021 valvular heart disease guidelines

Aims The ESC 2021 valvular heart disease [VHD] guidelines introduced an important and debated age cut-off (75 years) to lead the choice between surgical and transcatheter aortic valve implantation (TAVI) in non-high-risk patients. The aim of this study was to evaluate what impact an age cut-off has on clinical outcomes following TAVI in low-to-Intermediate Risk patients from a real word registry. Methods We performed the investigation in a large, contemporary, real-world, multicentre, international, retrospective registry of 3862 consecutive patients, comparing the rates of patient risk factors, procedural characteristics, complications, and outcomes in the populations with < or ≥ 75 years old. Results In our real-world cohort of 2977 patients with mean STS score of 3.6% (5.0–2.5), we found 301 (10.1%) patients with age <75 years and 2676 (89.9%) with ≥75 years. In the younger group compared with the older, we have a higher prevalence of male (44% vs. 35%, P=0.003), higher BMI (mean of 28.5 kg/m² vs. 26.7 kg/m², P = <0.001), diabetes (32% vs. 26%, P=0.027), insulin-dependent diabetes (12% vs. 7%, P=0.001), smoking (18% vs. 7%, P<0.001), COPD (26% vs. 16%, P<0.001). Moreover, younger patients presented less previous PM/ICD (6% vs. 11%, P=0.023), less atrial fibrillation (24% vs. 33%, P=0.033), less renal impairment (30% vs. 66%, P<0.001) and a lower mean STS score (2.6% vs. 3.7%, P<0.001). There was no difference in annular sizing, valvular and LVOT calcifications between the two groups. Older patients had a higher prevalence of porcelain aorta (2% for age<75 vs. 9%, P=0.001). Between the two groups no significant differences in procedural characteristics were observed, including rates of pre-dilatation (P=0.369), post-dilatation (P=0.159) and contrast volume (P=0.259). Procedural complications, in-hospital outcomes and 2-year Kaplan-Meier (KM) survival was equivalent between both groups (P=0.930). Finally, we assessed the best age cut-off related to 1-year mortality in our population, resulting in 86 years. Still, also in this scenario, the KM survival analysis did not show significant differences (P=0.120). Conclusions In our large real-world contemporary low-to-intermediate risk TAVI population, an age cut-off of 75 years was not associated with any difference in clinical outcomes and survival at 2-years follow-up. This data reinforces the concept that age alone is not a sufficient variable to be considered when choosing between TAVI or SAVR. The recent ESC 2021 VHD guidelines cut-off is justified only by the lack of evidence and valve durability strategy but not of a proper advantage age-related.

The RAGE Trial (Radial Arterial Graft in the Elderly)- A Pilot Study

Use of radial artery (RA) as a second arterial conduit in Coronary Artery Bypass Grafting (CABG) is well established and appreciated for its higher long-term patency rate compared to vein grafts. This study tends to investigate if there are any detrimental consequences when it is used in elderly (aged 60 and above) population of Bangladesh. A total of 71 patients who received RA grafts at elective, isolated CABG operation were consecutively enrolled in this study from May 2018 to September 2019. 31 patients were in the Elderly group and 40 patients were in the Non-elderly group. The groups were compared for baseline characteristics and co-morbidities; preoperative techniques, findings, events and procedures; and postoperative outcomes or end-point variables inclusive of local complications related to RA harvesting wound. Elderly and Non-elderly groups had statistically different age (p=0.000) and Society of Thoracic Surgery (STS) Score predicted mortality (p=0.000). Operative techniques, events, findings and procedures were similar. Clinical outcomes were found to be similar with no statistical difference between the groups. Number of deaths also was not statistically different. There were no local complications related to RA harvesting wound in either of the two groups. Harvesting and grafting of radial artery in suitable patients, using meticulous "no-touch" technique and for ideal target coronary artery stenosis is as safe in the elderly patients as in the younger ones. CBMJ 2020 July: Vol. 09 No. 02 P: 08-13

TAVR in patients with low-flow low-gradient aortic stenosis – outcome data after three years from one large centre

Background The outcome of patients with low-flow low-gradient (LFLG) aortic stenosis after transcatheter aortic valve replacement (TAVR) is not well evaluated. Long-term clinical success is thought to be less pronounced in LFLG patients compared to patients with high gradient (HG) aortic stenosis. Purpose The purpose of this study was to characterise different LFLG groups and determine their outcome after TAVR. We hypothesised that there would be relevant differences in baseline characteristics and patient survival after TAVR. Methods All patients undergoing TAVR for severe aortic stenosis at our centre between 2013 and 2019 were included in the study. Patients have been split into groups according preinterventional echocardiography data according to mean pressure gradient (dPmean), ejection fraction (EF), and stroke volume index (SVi). Patients with a dPmean <40 mmHg and SVi ≤35 ml/m2 were subdivided into classical low-flow low-gradient (cLFLG, EF <50%) and paradoxical low-flow (pLFLG, EF ≥50%). Patients with previous aortic valve replacement or severe aortic regurgitation were excluded from the analysis. Results 1,772 patients were analysed (mean follow-up 2.2 years, median age 81.7 [77.5–85.7] years) and split into groups: HG, 953 patients (54.3%), cLFLG, 446 patients (25.2%), and pLFLG 373 patients (21.1%). Baseline characteristics showed significant differences (p<0.01), among others, in sex (male sex, HG 46.1% vs. cLFLG 69.5% vs. pLFLG 44.5%), rate of atrial fibrillation (HG 20.3% vs. cLFLG 36.3% vs. pLFLG 41.6%), coronary artery disease (HG 56.2% vs. cLFLG 73.5% vs. pLFLG 63.4%), and grade 3 or 4 mitral regurgitation (HG 2.2% vs. cLFLG 5.5% vs. pLFLG 6.8%). Accordingly, Society of Thoracic Surgeons (STS) Scores differed significantly: HG, 3.0 [2.0–5.0], cLFLG, 5.0 [3.0–7.3] pLFLG, 3.9 [2.2–6.0] (p<0.01). Rates of periprocedural complications including death, device failure, pericardial effusion, stroke or myocardial infarction were comparable between groups. Mortality rate (figure 1) was highest for cLFLG patients (43.4% [95% confidence interval, 37.3–48.6%]) compared to HG (25.1% [21.6–28.5%]) or pLFLG (32.9% [26.9–38.4%]), Log-rank test, <0.001. Corresponding hazard ratios were 2.1 [1.7–2.6] (p<0.001) for cLFLG and 1.5 [1.2–2.0] (p<0.001) for pLFLG. Similar results were obtained when adjusting to STS score (figure 2). Conclusion In this all-comer analysis, almost half of the patients belong toLFLG groups with considerable differences in patient characteristics. While equally safe during the procedure, patients with LFLG aortic stenosis show increased 3-year mortality rates compared to patients with HG aortic stenosis. Further studies evaluating this are needed. FUNDunding Acknowledgement Type of funding sources: None. Figure 1. 3-year mortality Figure 2. STS score-adjusted mortality

Prognostic value of longitudinal assessment of hepatorenal function and nutritional status in patients undergoing valvular heart surgery

Background Hepatorenal dysfunction and malnutrition are frequent extracardiac consequences of valvular heart disease (VHD) and have emerged as prominent drivers of adverse prognosis in selected valvular interventions. Nonetheless, data in a general VHD population is sparse, and their interaction and changes following valvular surgery remain unexplored. Purpose We aim to characterise the temporal changes, interaction, and prognostic implications of hepatorenal dysfunction and malnutrition before and after valvular surgery. Methods Baseline and temporal changes in hepatorenal dysfunction (assessed by the modified model for end-stage liver disease [MELD-XI] score) and nutritional status (assessed by Controlling Nutritional Status [CONUT] score) were correlated with adverse events (composite of all-cause mortality and hospitalisation for heart failure) using Cox proportional hazards model, adjusted with clinical and echocardiographic covariates, medications, type of valvular procedure, and cardiac surgery risk-stratification models (EuroSCORE II and STS score). Results Our study included 909 patients who underwent valvular surgery. At baseline, 216 (24%) and 554 (61%) had hepatorenal dysfunction (MELD-XI >12.43) and malnutrition (CONUT ≥2), respectively. MELD-XI scores were modestly correlated with CONUT scores (R=0.36, p<0.001), with concomitant hepatorenal dysfunction and malnutrition present in 177 (19%) patients. Over a median follow-up of 4.1 years, 101 (11%) patients died and 119 (13%) were hospitalised for heart failure. There was a stepwise increase in mortality (χ2 89.1, p<0.001) and adverse events (χ2 92.9, p<0.001) from patients with normal hepatorenal function and nutrition to concomitant hepatorenal dysfunction and malnutrition (Figure 1). This association remained consistent in fully adjusted models. MELD-XI and CONUT scores significantly improved the discriminatory accuracy of EuroSCORE II (area under the curve [AUC]: 0.80 vs 0.73, p<0.001) and STS score (AUC: 0.79 vs 0.72, p=0.004) for all-cause mortality. In patients with MELD-XI and CONUT scores 1 year after surgery (n=707), ΔMELD-XI (follow-up MELD-XI minus baseline MELD-XI score) and ΔCONUT scores were significantly associated with adverse events (HR 1.08, 95% CI 1.03–1.14, p=0.001 for ΔMELD-XI; HR 1.18, 95% CI 1.02–1.35, p=0.02 for ΔCONUT). Patients remaining with hepatorenal dysfunction and malnutrition experienced worse survival (log-rank χ2 65.2, p<0.001) and adverse events (log-rank χ2 90.4, p<0.001) (Figure 2). Conclusions In patients undergoing valvular surgery, hepatorenal function and nutritional status at baseline, and their temporal changes, are strongly linked to clinical outcomes. These results highlight the role of hepatorenal and nutritional assessment for risk-stratification in valvular surgery. FUNDunding Acknowledgement Type of funding sources: None. Figure 1 Figure 2

EuroScore II is the best predictive model for the off pump coronary artery bypass graft surgery

Background Coronary artery bypass graft surgery (CABG) is the most common cardiac surgery performed in the world and a significant part of these surgeries are performed without cardiopulmonary bypass (off pump). Although none of the main surgical risk scores include pump use in their prediction model, the scores are widely used in risk stratification, including for patients who will be submitted to off pump CABG. Purpose To analyse and compare the predictive accuracy of EuroScore I, EuroScore II and STS Score for 30-day mortality after off pump CABG. Methods Single-centre cohort with 943 patients consecutively submitted to off pump CABG between January 2010 and December 2020. 31 baseline and operative variables were analysed. The primary outcome was the occurrence of death in the first 30 days after the surgery. Descriptive analysis, normality for quantitative data and univariate inference were performed to compare proportions and means between the survival group (n=930) and death group (n=13). Next, three logistic regression models were performed. Each of them had 30-day mortality as a dependent variable and one of the scores as an independent variable. The probabilities generated by the three models were saved and analysed by ROC curves. Thus, it was possible to assess the predictive accuracy of each of the scores. Finally, the values of the areas under the curves were compared using the DeLong test. The level of significance was 5% and the analysis was performed using the Python 3.0 programming language. Results The mean age of the general group was 63 years old and there was a predominance of male patients (68.4%). The means of the three evaluated risk scores were significantly higher in the Death group (p<0,05). This pattern confirmed the findings of higher prevalence of several comorbidities in the death group. The 30-day mortality rate was 1.37%. Through the analysis of regressions and the probabilities generated through them, it was possible to verify that the predictive accuracy of EuroScore II was significantly higher than that of the other two scores. While the predictive accuracy of EuroScore II was 77.3%, the accuracy of two other scores was in the range of 69% (AUC EsI: 0.697; AUC EsII: 0.773; AUC STS: 0.695; p=0.029). Conclusion EuroScore II seems to be the most adequate surgical risk score for the assessment of mortality risk of patients who will undergoing to off pump CABG. The score had a predictive accuracy of 77.3%, almost 8% more than the other two scores. Therefore, although EuroScore II does not include in its model the use of cardiopulmonary bypass, it has a satisfactory accuracy to be used in clinical-surgical practice. On the other hand, the EuroScore I and the STS Score showed predictive accuracy not adequate for this type of surgery. FUNDunding Acknowledgement Type of funding sources: None. Predictive accuracies of risk scores

Gender Differences after Transcatheter Aortic Valve Replacement (TAVR): Insights from the Italian Clinical Service Project

Background: TAVR is a safe alternative to surgical aortic valve replacement (SAVR); however, sex-related differences are still debated. This research aimed to examine gender differences in a real-world transcatheter aortic valve replacement (TAVR) cohort. Methods: All-comer aortic stenosis (AS) patients undergoing TAVR with a Medtronic valve across 19 Italian sites were prospectively included in the Italian Clinical Service Project (NCT01007474) between 2007 and 2019. The primary endpoint was 1-year mortality. We also investigated 3-year mortality, and ischemic and hemorrhagic endpoints, and we performed a propensity score matching to assemble patients with similar baseline characteristics. Results: Out of 3821 patients, 2149 (56.2%) women were enrolled. Compared with men, women were older (83 ± 6 vs. 81 ± 6 years, p < 0.001), more likely to present severe renal impairment (GFR ≤ 30 mL/min, 26.3% vs. 16.3%, p < 0.001) but had less previous cardiovascular events (all p < 0.001), with a higher mean Society of Thoracic Surgeons (STS) score (7.8% ± 7.1% vs. 7.2 ± 7.5, p < 0.001) and a greater mean aortic gradient (52.4 ± 15.3 vs. 47.3 ± 12.8 mmHg, p < 0.001). Transfemoral TAVR was performed more frequently in women (87.2% vs. 82.1%, p < 0.001), with a higher rate of major vascular complications and life-threatening bleeding (3.9% vs. 2.4%, p = 0.012 and 2.5% vs. 1.4%, p = 0.024). One-year mortality differed between female and male (11.5% vs. 15.0%, p = 0.002), and this difference persisted after adjustment for significant confounding variables (Adj.HR1yr 1.47, 95%IC 1.18–1.82, p < 0.001). Three-year mortality was also significantly lower in women compared with men (19.8% vs. 24.9%, p < 0.001) even after adjustment for age, STS score, eGFR, diabetes and severe COPD (Adj.HR3yr 1.42, 95%IC 1.21–1.68, p < 0.001). These results were confirmed in 689 pairs after propensity score matching. Conclusion: Despite higher rates of peri-procedural complications, women presented better survival than men. This better adaptive response to TAVR may be driven by sex-specific factors.