Risk-related short-term clinical outcomes after transcatheter aortic valve implantation and their impact on early mortality: an analysis of claims-based data from Germany

Objectives We aimed to define and assess risk-specific adverse outcomes after transcatheter aortic valve implantation (TAVI) in an all-comers patient population based on German administrative claims data. Methods Administrative claims data of patients undergoing transvascular TAVI between 2017 and 2019 derived from the largest provider of statutory health-care insurance in Germany were used. Patients’ risk profile was assessed using the established Hospital Frailty Risk (HFR) score and 30-day adverse events were evaluated. Multivariable logistic regression models were applied to investigate the relation of patients’ risk factors to clinical outcomes and, subsequently, of clinical outcomes to mortality. Results A total of 21,430 patients were included in the analysis. Of those, 51% were categorized as low-, 37% as intermediate-, and 12% as high-risk TAVI patients according to HFR score. Whereas low-risk TAVI patients showed low rates of periprocedural adverse events, TAVI patients at intermediate or high risk suffered from worse outcomes. An increase in HFR score was associated with an increased risk for all adverse outcome measures. The strongest association of patients’ risk profile and outcome was present for cerebrovascular events and acute renal failure after TAVI. Independent of patients’ risk, the latter showed the strongest relation with early mortality after TAVI. Conclusions Differentiated outcomes after TAVI can be assessed using claims-based data and are highly dependent on patients’ risk profile. The present study might be of use to define risk-adjusted outcome margins for TAVI patients in Germany on the basis of health-insurance data

Risk prediction in patients with low-flow, low-gradient aortic stenosis and reduced ejection fraction undergoing TAVI

Objective Patients with low-flow, low-gradient aortic stenosis (LFLG AS) and reduced left ventricular ejection fraction (LVEF) are known to suffer from poor prognosis after transcatheter aortic valve implantation (TAVI). This study aimed to develop a simple score system for risk prediction in this vulnerable subset of patients. Methods All patients with LFLG AS with reduced EF and sufficient CT data for aortic valve calcification (AVC) quantification, who underwent TAVI at five German centres, were retrospectively included. The Risk prEdiction in patients with Low Ejection Fraction low gradient aortic stenosis undergoing TAVI (RELiEF TAVI) score was developed based on multivariable Cox regression for all-cause mortality. Results Among all included patients (n=718), RELiEF TAVI score variables were defined as independent predictors of mortality: male sex (HR 1.34 (1.06, 1.68), p=0.013), underweight (HR 3.10 (1.50, 6.40), p=0.0022), chronic obstructive pulmonary disease (HR 1.55 (1.21, 1.99), p=0.001), pulmonary hypertension (HR 1.51 (1.17, 1.94), p=0.0015), atrial fibrillation (HR 1.28 (1.03, 1.60), p=0.028), stroke volume index (HR 0.96 (0.95, 0.98), p4 points) demonstrated rates of 18.0%, 29.0% and 46.1% (p<0.001) for all-cause mortality and 23.8%, 35.9% and 53.4% (p<0.001) for the combined endpoint of all-cause mortality or heart failure rehospitalisation after 1 year, respectively. Conclusions The RELiEF TAVI score is based on simple clinical, echocardiographic and CT parameters and might serve as a helpful tool for risk prediction in patients with LFLG AS and reduced LVEF scheduled for TAVI

Transcatheter aortic valve implantation in patients with a small aortic annulus: performance of supra-, intra- and infra-annular transcatheter heart valves

Background A small aortic annulus is associated with increased risk of prosthesis-patient mismatch (PPM) after transcatheter aortic valve implantation (TAVI). Whether specific transcatheter heart valve (THV) designs yield superior hemodynamic performance in these small anatomies remains unclear. Methods Data from 8411 consecutive patients treated with TAVI from May 2012 to April 2019 at four German centers were retrospectively evaluated. A small aortic annulus was defined as multidetector computed tomography-derived annulus area mild was more frequent after TAVI with self-expanding THV (p = 0.04). Conclusion In this large contemporary multicenter patient population, a substantial number of patients with a small aortic anatomy were left with PPM after TAVI. Self-expanding supra- and intra-annular THV demonstrated superior hemodynamics in these patients at risk, however at the cost of higher rates of residual paravalvular regurgitation. Graphic abstrac

Left Ventricular Unloading Is Associated With Lower Mortality in Patients With Cardiogenic Shock Treated With Venoarterial Extracorporeal Membrane Oxygenation

International audienceBackground: Venoarterial extracorporeal membrane oxygenation (VA-ECMO) is increasingly used to treat cardiogenic shock. However, VA-ECMO might hamper myocardial recovery. The Impella unloads the left ventricle. This study aimed to evaluate whether left ventricular unloading in patients with cardiogenic shock treated with VA-ECMO was associated with lower mortality. Methods: Data from 686 consecutive patients with cardiogenic shock treated with VA-ECMO with or without left ventricular unloading using an Impella at 16 tertiary care centers in 4 countries were collected. The association between left ventricular unloading and 30-day mortality was assessed by Cox regression models in a 1:1 propensity score–matched cohort. Results: Left ventricular unloading was used in 337 of the 686 patients (49%). After matching, 255 patients with left ventricular unloading were compared with 255 patients without left ventricular unloading. In the matched cohort, left ventricular unloading was associated with lower 30-day mortality (hazard ratio, 0.79 [95% CI, 0.63–0.98]; P =0.03) without differences in various subgroups. Complications occurred more frequently in patients with left ventricular unloading: severe bleeding in 98 (38.4%) versus 45 (17.9%), access site–related ischemia in 55 (21.6%) versus 31 (12.3%), abdominal compartment in 23 (9.4%) versus 9 (3.7%), and renal replacement therapy in 148 (58.5%) versus 99 (39.1%). Conclusions: In this international, multicenter cohort study, left ventricular unloading was associated with lower mortality in patients with cardiogenic shock treated with VA-ECMO, despite higher complication rates. These findings support use of left ventricular unloading in patients with cardiogenic shock treated with VA-ECMO and call for further validation, ideally in a randomized, controlled trial