scholarly journals Predictors and clinical outcomes of poor symptomatic improvement after transcatheter aortic valve replacement

Open Heart ◽  
2021 ◽  
Vol 8 (2) ◽  
pp. e001742
Author(s):  
Nobuhiro Yoshijima ◽  
Tetsuya Saito ◽  
Taku Inohara ◽  
Atsushi Anzai ◽  
Hikaru Tsuruta ◽  
...  

ObjectiveTranscatheter aortic valve replacement (TAVR) improves clinical symptoms in most patients with severe aortic stenosis (AS). However, some patients do not benefit from the symptom-reducing effects of TAVR. We assessed the predictors and clinical outcomes of poor symptomatic improvement (SI) after TAVR.MethodsA total of 1749 patients with severe symptomatic AS undergoing transfemoral TAVR were evaluated using the Japanese multicentre TAVR registry. Poor SI was defined as readmission for heart failure (HF) within 1 year after TAVR or New York Heart Association (NYHA) class ≥3 after 1 year. A logistic regression model was used to identify predictors of poor SI. One-year landmark analysis after TAVR was used to evaluate the association between poor SI and clinical outcomes.ResultsAmong the overall population (mean age, 84.5 years; female, 71.3%; mean STS score, 6.3%), 6.6% were categorised as having poor SI. Atrial fibrillation, chronic obstructive pulmonary disease, Clinical Frailty Scale ≥4, chronic kidney disease and moderate to severe mitral regurgitation were independent predictors of poor SI. One-year landmark analysis demonstrated that poor SI had a higher incidence of all-cause death and readmission for HF compared with SI (p<0.001). Poor SI with preprocedural NYHA class 2 had a worse outcome than SI with preprocedural NYHA class ≥3.ConclusionsPoor SI was associated with worse outcomes 1 year after the procedure. It had a greater impact on clinical outcomes than baseline symptoms. TAVR may be challenging for patients with many predictors of poor SI.Trial registration numberThis registry, associated with the University Hospital Medical Information Network Clinical Trials Registry, was accepted by the International Committee of Medical Journal Editors (UMIN-ID: 000020423).

2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Dominik Kylies ◽  
Sandra Freitag-Wolf ◽  
Florian Fulisch ◽  
Hatim Seoudy ◽  
Christian Kuhn ◽  
...  

Abstract Background Chronic kidney disease as well as acute kidney injury are associated with adverse outcomes after transcatheter aortic valve replacement (TAVR). However, little is known about the prognostic implications of an improvement in renal function after TAVR. Methods Renal improvement (RI) was defined as a decrease in postprocedural creatinine in μmol/l of ≥1% compared to its preprocedural baseline value. A propensity score representing the likelihood of RI was calculated to define patient groups which were comparable regarding potential confounders (age, sex, BMI, NYHA classification, STS score, log. EuroSCORE, history of atrial fibrillation/atrial flutter, pulmonary disease, previous stroke, CRP, creatinine, hsTNT and NT-proBNP). The cohort was stratified into 5 quintiles according to this propensity score and the survival time after TAVR was compared within each subgroup. Results Patients in quintile 5 (n = 93) had the highest likelihood for RI. They were characterized by higher creatinine, lower eGFR, higher NYHA class, higher NT-proBNP, being mostly female and having shorter overall survival time. Within quintile 5, patients without RI had significantly shorter survival compared to patients with RI (p = 0.002, HR = 0.32, 95% CI = [0.15–0.69]). There was no survival time difference between patients with and without RI in the whole cohort (p = 0.12) and in quintiles 1 to 4 (all p > 0.16). Analyses of specific subgroups showed that among patients with NYHA class IV, those with RI also had a significant survival time benefit (p < 0.001, HR = 0.15; 95%-CI = [0.05–0.44]) compared to patients without RI. Conclusions We here describe a propensity score-derived specific subgroup of patients in which RI after TAVR correlated with a significant survival benefit.


Author(s):  
Fenton McCarthy ◽  
Katherine M McDermott ◽  
Vinay Kini ◽  
Dale Kobrin ◽  
Nimesh D Desai ◽  
...  

Background: Transcatheter Aortic Valve Replacement (TAVR) demonstrated excellent outcomes in clinical trials of inoperable/high-risk patients. Subsequent approval by the Food and Drug Administration and National Coverage Determination by the Centers for Medicare and Medicaid Services established unique volume requirements for institutions and physicians to perform TAVR. Diffusion of prior cardiovascular interventions has involved less stringent policies and exhibited significant institutional variation in clinical outcomes. Our objective is to compare risk-standardized procedural outcomes across US hospitals performing TAVR to identify hospitals with outlying post-procedure mortality rates. Methods: All Medicare fee-for-service beneficiaries who underwent TAVR between January 1, 2011 and November 30, 2012 were identified. Thirty-day risk-standardized mortality rates (RSMR) were calculated using the Hospital Compare statistical method, a well-validated hierarchical generalized linear model. Results: Claims were examined from 5044 patients undergoing TAVR at 199 hospitals, with a crude 30-day mortality rate of 5.97%. RSMRs modeled using patient-level predictors varied from 4.5 % to 9.0 % (Figure 1). One hospital had a RSMR statistically lower than the national mean (4.5%, P<0.05), and two hospitals had RSMRs statistically higher than the national mean (8.5% and 6.9%, P<0.05). Conclusions: Clinical outcomes among TAVR hospitals in high-risk/inoperable patients demonstrated very little variability, few outliers, and excellent outcomes comparable to pre-approval clinical trials. This may be the result of the unique policy and regulatory environment governing the CMS coverage determination for TAVR institutions. As TAVR disseminates to additional hospitals and other new cardiovascular interventions are inevitably introduced, risk-standardized outcome comparisons across hospitals may facilitate ongoing surveillance to ensure high quality outcomes at all active centers.


Author(s):  
Tamim M. Nazif ◽  
Thomas J. Cahill ◽  
David Daniels ◽  
James M. McCabe ◽  
Mark Reisman ◽  
...  

Background: Paravalvular regurgitation (PVR) after transcatheter aortic valve replacement is associated with adverse clinical outcomes. The SAPIEN 3 Ultra (Ultra) is a new generation balloon-expandable transcatheter heart valve with a modified external skirt that is designed to reduce PVR, but reports of clinical and echocardiographic outcomes are limited. The aim of this study was to compare short-term outcomes of patients undergoing transcatheter aortic valve replacement with the Ultra and the original SAPIEN 3 (S3) transcatheter heart valve in a large national registry. Methods: Data from The Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry was used to compare patients who underwent elective, transfemoral transcatheter aortic valve replacement with the Ultra or S3 transcatheter heart valve. Clinical and echocardiographic outcomes were analyzed in a propensity-matched cohort at discharge and 30 days. Results: Patients who underwent transcatheter aortic valve replacement with Ultra (N=1324) from January 2019 to February 2020 were propensity score–matched with patients treated with S3 (N=32 982) during the same period, resulting in 1324 matched pairs. There was no difference in the rate of device success between patients treated with Ultra and S3 (97.1% versus 98.0%, P =0.11). At hospital discharge, PVR was significantly reduced with Ultra compared with S3, with mild PVR in 9.0% versus 13.9% and moderate or greater PVR in 0.1% versus 0.4% (overall P <0.01). At 30 days, there were no differences between Ultra and S3 recipients in the rates of all-cause mortality or stroke (1.8% versus 2.8%, P =0.10), major vascular complications (1.1% versus 1.0%, P =0.84), or permanent pacemaker implantation (6.4% versus 6.2%, P =0.81). Conclusions: In this propensity-matched analysis from the Transcatheter Valve Therapy Registry, the Ultra transcatheter heart valve was associated with similar procedural and 30-day clinical outcomes, but reduced incidence of PVR, compared with S3. The clinical benefit of less PVR should be evaluated in longer-term studies.


2018 ◽  
Vol 11 (1) ◽  
pp. 1-12 ◽  
Author(s):  
Alaide Chieffo ◽  
Anna Sonia Petronio ◽  
Julinda Mehilli ◽  
Jaya Chandrasekhar ◽  
Samantha Sartori ◽  
...  

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