scholarly journals Comparison of clinical outcomes in elderly patients undergoing TAVR- a nationwide analysis

Author(s):  
Mukunthan Murthi ◽  
Sujitha Velagapudi ◽  
Bharosa Sharma ◽  
Olisa Ezegwu Kingsley ◽  
Emmaunuel Akuna

Introduction Transcatheter aortic valve replacement (TAVR) is a less invasive alternative to traditional surgical aortic valve replacement (SAVR) that has been increasingly utilized in the management of aortic stenosis. Several studies have compared the outcomes of TAVR to SAVR, and studies have also compared the clinical outcomes in the elderly population. However, the comparison in outcomes of TAVR between patients more than 80 years and less than 80 years old has not been well characterized. Therefore, in this study, we sought to assess the hospital outcomes and major adverse events of TAVR in patients ≥80 years old compared to those <80 years. Methods We performed a retrospective observational study using the National Inpatient Sample for the year 2018. Using the International Classification of Diseases, Tenth Revision, Clinical Modification (ICD-10) procedure codes we identified patients who underwent TAVR. We further divided these patients into two cohorts based on age being ≥80 years and <80 years old. The primary outcomes were the comparison of in-hospital mortality and major adverse events (MAE) in patients with TAVR procedure stratified based on age. Secondary analysis included sub-groups analysis of both the cohorts and comparing those with and without MAE as well as comparison of those with MAE only in both cohorts. Results We identified 63,630 patients who underwent TAVR procedures from January 1 to December 31, 2018. Among them, 35, 115(55%) were ≥80 years and 28,515(45%) were <80 years of age. There was no difference in the in-hospital mortality rate (1.6% vs. 1.1%, p=0.89) and rates of MAE (23.8 vs 23.4, p=0.49) between ≥80 and <80year patients. Anemia (aOR-2.12 vs. aOR-1.93), Liver disease (aOR-1.57 vs aOR-1.48), CKD (aOR-1.34 vs. aOR-1.68), history of stroke (aOR-1.54 vs. aOR-1.46), and a higher number of comorbidities were independently associated with higher odds of MAE in both groups. Among patients ≥80, increasing age was also associated with higher MAE (aOR-1.03). In patients who had MAE, those < 80 years had higher comorbidities compared to those ≥80 years (Charlson category ≥3 - 74.5 vs 67%, p<0.001). More patients of age ≥80 years old also belonged to zip-codes with higher median income (p<0.001). On multivariate analysis of patients with MAE on both cohorts, there was no significant difference in in-hospital mortality rate (p=0.65) and length of stay (p=0.12) but total hospital charges were higher for patients less than 80 years of age (283,618 vs 300,624$, p=0.04). However, patients ≥80 years had a higher rate of pacemaker insertion compared to those < 80 years (25.1 vs 24.4%, p=0.008). Conclusion This study shows that in patients undergoing TAVR, the in-hospital mortality and MAE were not statistically significant between those aged ≥80 years and < 80 years. However, among subjects who experienced MAE, those < 80 years had a higher proportion of comorbidities than those ≥80 years of age. Our study also shows that for those above 80 years of age undergoing TAVR, the odds of MAE increases by 3% for each year on increasing age.

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
S.M Piepenburg ◽  
K Kaier ◽  
C Olivier ◽  
M Zehender ◽  
C Bode ◽  
...  

Abstract Introduction and aim Current emergency treatment options for severe aortic valve stenosis include surgical aortic valve replacement (SAVR), transcatheter aortic valve replacement (TAVR) and balloon valvuloplasty (BV). So far no larger patient population has been evaluated regarding clinical characteristics and outcomes. Therefore we aimed to describe the use and outcome of the three therapy options in a broad registry study. Method and results Using German nationwide electronic health records, we evaluated emergency admissions of symptomatic patients with severe aortic valve stenosis between 2014 and 2017. Patients were grouped according to SAVR, TAVR or BV only treatments. Primary outcome was in-hospital mortality. Secondary outcomes were stroke, acute kidney injury, periprocedural pacemaker implantation, delirium and prolonged mechanical ventilation &gt;48 hours. Stepwise multivariable logistic regression analyses including baseline characteristics were performed to assess outcome risks. 8,651 patients with emergency admission for severe aortic valve stenosis were identified. The median age was 79 years and comorbidities included NYHA classes III-IV (52%), coronary artery disease (50%), atrial fibrillation (41%) and diabetes mellitus (33%). Overall in-hospital mortality was 6.2% during a mean length of stay of 22±15 days. TAVR was the most common treatment (6,357 [73.5%]), followed by SAVR (1,557 [18%]) and BV (737 8.5%]). Patients who were treated with TAVR or BV were significantly older than patients with SAVR (mean age 81.3±6.5 and 81.2±6.9 versus 67.2±11.0 years, p&lt;0.001), had more relevant comorbidities (coronary artery disease 52–91% vs. 21.8%; p&lt;0.001), worse NYHA classes III-IV (55–65% vs. 34.5%; p&lt;0.001) and higher EuroSCORES (24.6±14.3 and 23.4±13.9 vs. 9.5±7.6; p&lt;0.001) than SAVR patients. Patients treated with BV only had the highest in-hospital mortality compared with TAVR or SAVR (20.9% vs. 5.1 and 3.5%; p&lt;0.001). Compared with BV only, SAVR patients (adjusted odds ratio [aOR] 0.25; 95% confidence interval [CI] 0.14–0.46; p&lt;0.001) and TAVR patients (aOR 0.37; 95% CI 0.28–0.50; p&lt;0.001) had a lower risk for in-hospital mortality. Conclusion In-hospital mortality for emergency patients with symptomatic severe aortic valve stenosis is high. Our results showed that BV only therapy was associated with highest mortality, which is in line with current research. Yet, there is a trend towards more TAVR interventions and this study might imply that balloon valvuloplasty alone is insufficient. The role of BV as a bridging strategy to TAVR or SAVR needs to be further investigated. Funding Acknowledgement Type of funding source: Public hospital(s). Main funding source(s): Heart Center Freiburg University, Department of Cardiology and Angiology I, Faculty of Medicine, University of Freiburg, Freiburg, Germany


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 72 (4) ◽  
pp. 475-476 ◽  
Author(s):  
Peter Stachon ◽  
Manfred Zehender ◽  
Christoph Bode ◽  
Constantin von zur Mühlen ◽  
Klaus Kaier

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

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