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Predicting Quality of Life at 1 Year After Transcatheter Aortic Valve Replacement in a Real-World Population.

ABSTRACT: Background Among clinical trial patients at high surgical risk, a model has been developed and externally validated to estimate patient risk for poor outcomes after transcatheter aortic valve replacement (TAVR). How this model performs in lower risk and unselected patients is not known. We sought to examine and optimize the performance of the TAVR poor outcome risk model among patients in the US Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry. Methods and Results Among 13 351 patients who underwent TAVR at 252 US sites between November 9, 2011 and June 30, 2015, the rate of poor outcome at 1 year after TAVR was 38.9%, which was because of death in 20.7% and poor quality of life or quality of life decline in 18.2%. The rate of poor outcome has decreased slightly over time, from 42.0% in 2012 to 37.8% in 2015 ( P for trend=0.076). The original TAVR poor outcome risk model did not calibrate well on this population. We then reestimated the intercept and coefficients in the model and retested model performance, after which it performed well (both overall and in subgroups), with a C index 0.65 and excellent calibration. Conclusions In a large cohort of unselected patients in the United States, we found that while a substantial minority of patients continue to have a poor outcome after TAVR, outcomes have slowly improved over time. After recalibration, the TAVR poor outcome risk model performed well. This model could potentially be used before TAVR to help patients have appropriate expectations of recovery.

SUBMITTER: Arnold SV

PROVIDER: S-EPMC6207214 | biostudies-literature | 2018 Oct

REPOSITORIES: biostudies-literature

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Predicting Quality of Life at 1 Year After Transcatheter Aortic Valve Replacement in a Real-World Population.

Arnold Suzanne V SV Cohen David J DJ Dai David D Jones Philip G PG Li Fan F Thomas Laine L Baron Suzanne J SJ Frankel Naftali Z NZ Strong Susan S Matsouaka Roland A RA Edwards Fred H FH Brennan J Matthew JM

Circulation. Cardiovascular quality and outcomes 20181001 10

Background Among clinical trial patients at high surgical risk, a model has been developed and externally validated to estimate patient risk for poor outcomes after transcatheter aortic valve replacement (TAVR). How this model performs in lower risk and unselected patients is not known. We sought to examine and optimize the performance of the TAVR poor outcome risk model among patients in the US Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry. Met ...[more]

PMID: 30354575

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Project description:ImportanceHospital outcomes for transcatheter aortic valve replacement (TAVR) may be dependent on the quality of evaluation, personnel, and procedural and postprocedural care common to patients undergoing cardiac surgery.ObjectivesWe sought to assess whether those hospitals with better patient outcomes for surgical aortic valve replacement (SAVR) subsequently achieved better TAVR outcomes after launching TAVR programs.Design, setting, and participantsThis national cohort included US patients 65 years and older. The analysis used the Centers for Medicare and Medicaid Services' Medicare Provider and Review data collected between January 1, 2010, and September 29, 2015. Only hospitals performing at least 1 SAVR prior to September 1, 2011, and performing at least 1 TAVR after this date were included in the analysis. Data analysis was completed from June 2018 to August 2018.InterventionsIsolated aortic valve replacements.Main outcomes and measuresHospital risk-adjusted 30-day mortality for SAVR in the pre-TAVR period was used as a surrogate for SAVR quality. Thirty-day and 1-year TAVR mortality rates were examined after stratification by quartile of baseline hospital risk-adjusted SAVR mortality.ResultsA total of 51 924 TAVR procedures were performed in 519 hospitals, of which 19 798 were performed at hospitals in quartile 1 (the lowest risk-adjusted SAVR mortality rate), 7663 were performed in quartile 2, 10 180 were performed in quartile 3, and 14 283 were performed in quartile 4 (the highest risk-adjusted SAVR mortality rate). Observed mortality rates at 30 days consistently increased with increasing baseline hospital SAVR risk-adjusted mortality (quartile 1, 917 patients [4.6%]; quartile 2, 381 [5.0%]; quartile 3, 521 [5.1%]; quartile 4, 800 [5.6%]; P < .001). The same pattern was observed in 1-year mortality (quartile 1, 3359 [17.0%]; quartile 2, 1337 [17.5%]; quartile 3, 1852 [18.2%]; quartile 4, 2652 [18.6%]; P < .001). After multivariable analysis, compared with the lowest quartile of SAVR mortality, undergoing TAVR at a hospital with higher baseline SAVR mortality continued to be associated with higher 30-day mortality (odds ratios: quartile 2, 1.02 [95% CI, 0.87-1.21]; quartile 3, 1.13 [95% CI, 1.02-1.26]; quartile 4, 1.23 [95% CI, 1.07-1.40]; P = .02) and 1-year mortality (hazard ratios: quartile 2, 1.04 [95% CI, 0.92-1.17]; quartile 3, 1.14 [95% CI, 1.02-1.28]; quartile 4, 1.16 [95% CI, 1.05-1.28]; P = .02).Conclusions and relevanceHospitals with higher SAVR mortality rates also had higher short-term and long-term TAVR mortality after initiating TAVR programs. Quality of cardiac surgical care may be associated with a hospital's performance with new structural heart disease programs.

Project description:BackgroundThe approved use of transcatheter aortic valve replacement (TAVR) for aortic stenosis has expanded substantially over time. However, gaps remain with respect to accurately delineating risk for poor clinical and patient-centered outcomes. Our objective was to develop prediction models for 30-day clinical and patient-centered outcomes after TAVR within a large, diverse community-based population.MethodsWe identified all adults who underwent TAVR between 2013-2019 at Kaiser Permanente Northern California, an integrated healthcare delivery system, and were monitored for the following 30-day outcomes: all-cause death, improvement in quality of life, all-cause hospitalizations, all-cause emergency department (ED) visits, heart failure (HF)-related hospitalizations, and HF-related ED visits. We developed prediction models using gradient boosting machines using linked demographic, clinical and other data from the Society for Thoracic Surgeons (STS)/American College of Cardiology (ACC) TVT Registry and electronic health records. We evaluated model performance using area under the curve (AUC) for model discrimination and associated calibration plots. We also evaluated the association of individual predictors with outcomes using logistic regression for quality of life and Cox proportional hazards regression for all other outcomes.ResultsWe identified 1,565 eligible patients who received TAVR. The risks of adverse 30-day post-TAVR outcomes ranged from 1.3% (HF hospitalizations) to 15.3% (all-cause ED visits). In models with the highest discrimination, discrimination was only moderate for death (AUC 0.60) and quality of life (AUC 0.62), but better for HF-related ED visits (AUC 0.76). Calibration also varied for different outcomes. Importantly, STS risk score only independently predicted death and all-cause hospitalization but no other outcomes. Older age also only independently predicted HF-related ED visits, and race/ethnicity was not significantly associated with any outcomes.ConclusionsDespite using a combination of detailed STS/ACC TVT Registry and electronic health record data, predicting short-term clinical and patient-centered outcomes after TAVR remains challenging. More work is needed to identify more accurate predictors for post-TAVR outcomes to support personalized clinical decision making and monitoring strategies.

Project description:Background: Transcatheter aortic valve replacement (TAVR) has developed to the therapy of choice for patients with symptomatic severe aortic stenosis who are unsuitable for surgical aortic valve replacement and elderly patients with intermediate or high operative risk. However, the optimal anticoagulant therapy post-TAVR still remains a matter of debate. Aims: This study sought to investigate current anticoagulant treatment patterns and clinical outcome in patients undergoing TAVR. Methods: In a retrospective study based on anonymized health claims data of approximately seven million Germans with statutory health insurance (InGef database), anticoagulant treatment regimens were assessed using any drug prescription post discharge within the first 90 days after TAVR procedure. Clinical events between 30 days and 6 months were examined by treatment regime. Results: The study population comprised 4,812 patients with TAVR between 2014 and 2018: 29.4% received antiplatelet monotherapy, 17.8% dual antiplatelet therapy, 17.4% oral anticoagulation (OAC) plus antiplatelet therapy, 12.9% OAC monotherapy, 2.2% triple therapy and 19.2% did not receive any anticoagulatory drugs. Sixty-four percentage of patients with OAC received direct oral anticoagulants (DOAC). Hence, 68% of all patients were treated non-adherent to current guidelines. Forty percentage of patients with OAC prior to TAVR did not have any OAC after TAVR. The adjusted risk of all-cause mortality was significantly increased in patients with OAC (HR 1.40, 95% CI 1.03-1.90, p = 0.03) and no anticoagulatory treatment (HR 3.95, 95% CI 2.95-5.27, p < 0.0001) when compared to antiplatelet monotherapy. Conclusions: This large real-world data analysis demonstrates substantial deviations from guideline recommendations and treatment after TAVR. Considering relevant differences in clinical outcome across treatment groups, major effort is warranted to examine underlying causes and improve guideline adherence.

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Predicting Quality of Life at 1 Year After Transcatheter Aortic Valve Replacement in a Real-World Population.

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Predicting Quality of Life at 1 Year After Transcatheter Aortic Valve Replacement in a Real-World Population.

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