Correction: Critical insights into the ''New risk model for prognostic prediction after surgical aortic valve replacement in Hemodialysis patients''.

Transcatheter aortic valve replacement valve-in-valve: Future implications for the surgeon

Background Chronic kidney disease (CKD) is a key risk factor in patients undergoing transcatheter aortic valve implantation (TAVI) or surgical aortic valve replacement (SAVR). Purpose We analyzed the impact of eGFR and different stages of chronic kidney disease (CKD), on short- and mid-term survival in patients undergoing TAVI or SAVR. Methods Data from 29893 patients enrolled in the German Aortic Valve registry (GARY) from January 2011 to December 2015 receiving TAVI (n=12834) or SAVR (n=17059) at 88 sites were included. The impact of renal impairment, as measured by eGFR and CKD stages, was investigated. The primary endpoint was 1-year cumulative all-cause mortality. A propensity score method was used to compare TAVI vs. SAVR in patients with intermediate risk and mild-to-moderate renal disease being eligible for both therapies. Results Higher CKD stages were significantly associated to lower in-hospital, 30-day- and 1-year survival rates. Both TAVI- and SAVR-treated patients in CKD 3a, 3b, 4, and 5 stages showed significant and gradually increasing HR values for 1-year all-cause mortality. The same trend persisted in multivariable analysis, although HR values for CKD 3a and 5 did not reach significance in TAVI patients, whereas CKD 4+5 did not reach statistical significance in SAVR. Likewise, eGFR as a continuous variable was a significant predictor for 1-year mortality, with the best cut-off points being 47.4 mL/min/1.73 m2 for TAVI and 59.8 mL/min/1.73 m2 for SAVR. Significant 8.6% and 9.0% increases in 1-year mortality were observed for every 5-mL reduction in eGFR for TAVI and SAVR, respectively. No significant differences in survival were found between TAVI and SAVR in a matched group of intermediate-risk patients potentially eligible for both therapies (HR [(95% CI] for TAVI vs SAVR 1.24 [0.76, 2.02], p=0.240). Conclusions CKD≥3b and CKD≥3a is an independent major risk factor for mortality in patients undergoing TAVI and SAVR, respectively. In the overall population of patients with severe aortic stenosis, an appropriate stratification based on CKD substage may contribute to a better selection of patients suitable for such therapies. TAVI and SAVR appear to achieve similar survival rates in intermediate-risk patients with moderate-to-severe renal dysfunction. Funding Acknowledgement Type of funding source: Private grant(s) and/or Sponsorship. Main funding source(s): Unrestricted grants by medical device companies (Edwards Lifesciences, JenaValve Technology, Medtronic, Sorin, St. Jude Medical, Symetis S.A.). Unrestricted support by funding statisticians by the DZHK (Deutsches Zentrum für Herz-Kreislaufforschung).

Comparative Outcomes of Surgical and Transcatheter Aortic Valve Replacement for Aortic Stenosis in Nonagenarians

IntroductionTrans-catheter aortic valve implantation is now a Class 1 recommendation for high-risk patients alongside surgical aortic valve replacements and a Class 2 a recommendation for intermediate risk patients (AHA 2017...

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Background Severe aortic stenosis (AS) is associated with profound functional impairment. While valve replacement with surgical aortic valve replacement (SAVR) or transcatheter aortic valve implantation (TAVI) is associated with improvements in symptoms and mortality, many patients experience persistent functional limitations that could benefit from early inpatient exercise-based cardiac rehabilitation (EBCR). Purpose To determine changes in functional capacity following early inpatient EBCR following SAVR or TAVI for severe AS, and to determine if this differs by surgical approach (SAVR vs TAVR). Methods Patients referred for early inpatient EBCR following SAVR or TAVI between December 2022 and June 2024 who completed six-minute walk test assessments at admission and discharge from EBCR were included in this retrospective single-center study. Functional capacity was assessed from the distance covered during a six-minute walk test (6MWD) completed in accordance with guidelines from the American Thoracic Society. Patients were sub-grouped into TAVI (n=33) and SAVR approaches including mini-thoracotomy (n=22), hemi-sternotomy (n=67) and sternotomy (n=24). Results for 6MWD were compared in relation to normative age-, sex- and body mass index predicted 6MWD values for patients undergoing EBCR from our center, as well as published predictive 6MWD values for community-dwelling healthy older adults. Results Overall, 146 patients were included in the current analysis. Compared to the SAVR groups, patients who had undergone TAVI were older and had a higher proportion of females (Table 1). At admission, and regardless of the surgical approach, all patient groups had 6MWD values that were well below healthy reference values (Figure 1). TAVI patients had lower 6MWD than all three SAVR groups (P=0.035), although, this was largely explained by their older age, as the deficit in 6MWD relative to age-matched healthy referent values was similar to SAVR-sternotomy and SAVR-hemi-sternotomy (but not SAVR mini-thoracotomy) groups. All groups showed substantial improvements in 6MWD following inpatient EBCR (Table 1 and Figure 1), although TAVI patients showed significantly less (P=0.006) improvement (84m [45-124m]) than SAVR-mini-thoracotomy (128, [95-151m]), SAVR-hemi-sternotomy (147m [98-196m]) and SAVR-sternotomy patients (159m [100-223m]), such that their median post-EBCR 6MWD values remained 123-138m below the median value for the SAVR groups (P<0.001), and failed to reach age-predicted healthy referent values. Conclusion Early inpatient EBCR results in significant improvements in functional capacity for patients who have undergone TAVI or SAVR for severe AS. However, TAVI patients experience lesser improvements and persistent functional limitations at discharge compared to SAVR patients, that suggests a longer period of EBCR may be required for this vulnerable patient population.Regression of age vs 6MWD Baseline characteristics

Introduction Both surgical and transcatheter aortic valve replacement are effective interventions for treatment of patients with severe aortic stenosis. Data from landmark randomized trials have shown comparable improvement in aortic valve hemodynamics and left ventricular remodeling. Whether similar patterns will be observed in real-world practice has not been completely investigated. Purpose To compare the impact of transcatheter aortic valve replacement (TAVR) and surgical aortic valve replacement (SAVR) on short- and intermediate-term changes in aortic valve hemodynamics and left ventricular reverse-remodeling. Methods A total of 213 patients with severe AS were referred for TAVR (n=137) or SAVR (n=76) at a single center (August/ 2015-Feb/ 2021). Patient demographics and echocardiographic parameters of aortic valve stenosis severity were collected retrospectively. Changes over-time in aortic valve area, mean gradient, dimensionless index, left ventricular ejection fraction (EF), and ventricular septal thickness were examined using linear mixed models. Results Patients undergoing TAVR were older with higher STS risk scores and a greater burden of comorbidities (Table). Over a median follow-up of 13 months (IQR 4–31), both groups experienced a significant reduction in aortic valve mean gradient (25.7 mmHg with TAVR and 18.8 mmHg with SAVR), with no significant between-group difference (P=0.15). Aortic valve dimensionless index significantly increased in TAVR and SAVR groups (0.23 and 0.13, respectively) and was more pronounced in the TAVR group (P=0.01). Similarly, aortic valve area increased significantly in both groups (0.66 cm2 and 0.42 cm2, respectively) without a significant across-group difference (P=0.07). On the other hand, left ventricular ejection fraction did not change significantly over time (−0.61 and 1.15 EF points, respectively) with no significant between-group difference at 12 months (P=0.06). Ventricular septal thickness was significantly reduced in both groups, with no significant between group difference (P=0.4; Figure). Conclusion In this real-world experience, both TAVR and SAVR were associated with significant improvement in aortic valve hemodynamic parameters and modest reverse left ventricular remodeling. Furthermore, these changes were comparable with both modalities, adding to available evidence from randomized clinical trials on beneficial effects of both TAVR and SAVR. Funding Acknowledgement Type of funding sources: None. Table 1Figure 1

Assessment of frailty is important for risk stratification among the elderly with severe aortic stenosis (AS) when considering interventions such as surgical aortic valve replacement (SAVR) or transcatheter aortic valve replacement (TAVR). However, evidence of the impact of preoperative frailty on short-term postoperative outcomes or functional recovery is limited. This retrospective study included 234 consecutive patients with severe AS who underwent SAVR or TAVR at Kobe University Hospital between Dec 2013 and Dec 2019. Primary outcomes were postoperative complications, postoperative 6-min walking distance (6MWD), and home discharge rates. The mean age was 82 ± 6.6 years. There were 169 (SAVR: 80, TAVR: 89) and 65 (SAVR: 20, TAVR: 45) patients in the non-frail and frail groups, respectively (p = 0.02). The postoperative complication rates in the frail group were significantly higher than those in the non-frail group [30.8% (SAVR: 35.0%, TAVR: 28.9%) vs. 10.7% (SAVR: 15.0%, TAVR: 6.7%), p < 0.001]. The home discharge rate in the non-frail group was significantly higher than that in the frail group [85.2% (SAVR: 81.2%, TAVR: 88.8%) vs. 49.2% (SAVR: 55.0%, TAVR: 46.7%), p < 0.001]. The postoperative 6MWD in the non-frail group was significantly longer than that in the frail group [299.3 ± 87.8 m (SAVR: 321.9 ± 90.8 m, TAVR: 281.1 ± 81.3 m) vs. 141.9 ± 92.4 m (SAVR: 167.8 ± 92.5 m, TAVR: 131.6 ± 91.3 m), p < 0.001]. The TAVR group did not show a decrease in the 6MWD after intervention, regardless of frailty. We report for the first time that preoperative frailty was strongly associated with postoperative complications, 6MWD, and home discharge rates following both SAVR and TAVR. Preoperative frailty assessment may provide useful indications for planning better individualized therapeutic interventions and supporting comprehensive intensive care before and after interventions.

Surgical and transcatheter aortic valve replacement for severe aortic stenosis in low-risk elective patients: Analysis of the Aortic Valve Replacement in Elective Patients From the Aortic Valve Multicenter Registry

5-Year Outcomes Comparing Surgical Versus Transcatheter Aortic Valve Replacement in Patients With Chronic Kidney Disease

Self-Expanding Versus Balloon-Expandable Valve: Are We at the Cusp of Delivering a Perfect Transcatheter Aortic Valve?

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&amp;lt;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

The purpose of this study was to evaluate the incidence of new pacemaker implantation (NPMI) after surgical aortic valve replacement (SAVR) and transcatheter aortic valve replacement (TAVR), and investigate its influence on 1-year mortality. Patients who were enrolled in 'The German Aortic Valve Registry' undergoing isolated TAVR or SAVR between 2011 and 2015 were analysed. The rate of NPMI was analysed for both groups and multivariable Cox regression analysis was performed to investigate the possible independent association between NPMI and 1-year mortality. Twenty thousand eight hundred and seventy-two patients who underwent TAVR and 17750 patients who received SAVR were included in this study. The rate of NPMI was 16.6% after TAVR and 3.6% after SAVR. In the TAVR group, NPMI was associated with significantly increased 1-year mortality in univariable Cox regression analysis [hazard ratio (HR) 1.29, confidence interval (CI) 1.18-1.41; P < 0.001]. This association persisted after adjustment for confounding factors (HR 1.29, CI 1.16-1.43; P < 0.001). In the SAVR group, NPMI significantly increased 1-year mortality in univariable analysis as well (HR 1.55, CI 1.08-2.22; P = 0.02), whereas after multivariable adjustment, NPMI did not emerge as an independent risk factor (HR 1.29, 0.88-1.89; P = 0.19). NPMI was not associated with 30-day mortality in both procedure groups. The rate of NPMI was markedly higher after TAVR compared with SAVR and was independently associated with 1-year mortality after TAVR, whereas this was not significant after SAVR. As 30-day mortality was not different for TAVR and SAVR, the subsequent procedure of an NPMI itself seems not to increase the risk of mortality.

A Paradox between LV Mass Regression and Hemodynamic Improvement after Surgical and Transcatheter Aortic Valve Replacement

Recent reports describe increases in the case volume of surgical aortic valve replacement (SAVR) after centers establish a transcatheter aortic valve replacement (TAVR) program. We investigate contemporary temporal trends in SAVR and TAVR case volumes and risk profiles at a high volume academic medical center. We conducted a retrospective, descriptive evaluation of consecutive patients who underwent TAVR (n = 538) or SAVR (n = 657) in 2011-2016. The STS predicted risk of mortality (PROM) for isolated SAVR was used to calculate PROM for both SAVR and TAVR patients. Patients were stratified based on STS PROM as follows: low risk (<4%), intermediate risk (4-8%), and high risk (≥8%). Temporal changes in patient risk-profile were characterized descriptively. Median STS PROM for the study period was 6.3% and 2.0% for TAVR and SAVR cohorts, respectively (P < 0.001). Since 2011, TAVR volume consistently increased, while SAVR volume increased initially, peaking in 2013 and steadily declined. The STS PROM for SAVR remained stable during the entire study period, while that for TAVR showed a steady decline. The proportions of intermediate and low STS PROM patients undergoing TAVR increased. Proportions of each risk category in SAVR cohort remained stable over time. SAVR volume increased initially but declined eventually following the implementation of TAVR program. The distribution of the STS PROM in TAVR cohort changed dramatically with increasing proportion of patients in lower risk categories. These findings suggest the converging patient populations in TAVR and SAVR, which may be associated with the decline in the overall SAVR volume.