Dataset Information

A Risk Model for 1-Year Mortality After Transcatheter Aortic Valve Replacement From the J-TVT Registry.

ABSTRACT:

Background

Although transcatheter aortic valve replacement (TAVR) has demonstrated favorable outcomes in randomized studies, there remains a sizable group of patients in whom TAVR may be futile. Characterizing the survival rate in a wide array of patients undergoing TAVR can help develop effective strategies for improving the allocation of medial resources.

Objectives

The aim of this study was to develop a risk model to estimate 1-year mortality after TAVR from a representative nationwide registry in Japan.

Methods

The J-TVT (Japan Transcatheter Valve Therapies) registry contains complete data, including 1-year outcomes, on patients undergoing TAVR in Japan. A total of 17,655 patients underwent TAVR between 2013 and 2018. They were randomly divided into 2 groups in a 7:3 ratio to form a derivation cohort of 12,316 patients and a validation cohort of 5,339 patients. A risk model was constructed for 1-year mortality in the derivation cohort, and its discrimination and calibration were assessed in the validation cohort.

Results

The mean age of all registered patients was 84.4 years, and 68.8% were women. The mean body size area was 1.43 m², and the mean Society of Thoracic Surgeons Predicted Risk of Mortality score was 7.3%. The estimated 1-year survival was 91.8%; 202 and 1,316 deaths were observed at 30 days and 1 year, respectively; The estimated C index for the developed model was 0.733 (95% CI: 0.709-0.757) in the validation cohort, with good calibration.

Conclusions

A prediction model for 1-year survival following TAVR derived from a national clinical database performed well and should aid physicians managing TAVR patients.

SUBMITTER: Maeda K

PROVIDER: S-EPMC9743452 | biostudies-literature | 2022 Oct

REPOSITORIES: biostudies-literature

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Publications

A Risk Model for 1-Year Mortality After Transcatheter Aortic Valve Replacement From the J-TVT Registry.

Maeda Koichi K Kumamaru Hiraku H Kohsaka Shun S Shimamura Kazuo K Mizote Isamu I Yamashita Kizuku K Kawamura Ai A Mukai Takashi T Nakamura Daisuke D Takeda Yasuharu Y Shimizu Hideyuki H Sakata Yasushi Y Kuratani Toru T Miyagawa Shigeru S Sawa Yoshiki Y

JACC. Asia 20221004 5

<h4>Background</h4>Although transcatheter aortic valve replacement (TAVR) has demonstrated favorable outcomes in randomized studies, there remains a sizable group of patients in whom TAVR may be futile. Characterizing the survival rate in a wide array of patients undergoing TAVR can help develop effective strategies for improving the allocation of medial resources.<h4>Objectives</h4>The aim of this study was to develop a risk model to estimate 1-year mortality after TAVR from a representative na ...[more]

PMID: 36518724

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Project description:ImportanceTranscatheter aortic valve replacement (TAVR) was approved by the US Food and Drug Administration for severe aortic stenosis in patients who cannot undergo surgery and for patients at high operative risk. Use of TAVR for off-label indications has not been previously reported.ObjectiveTo evaluate patterns and adverse outcomes of off-label use of TAVR in US clinical practice.Design, setting and participantsPatients receiving commercially funded TAVR in the United States are included in the Transcatheter Valve Therapy Registry. A total of 23 847 patients from 328 sites performing TAVR between November 9, 2011, and September 30, 2014, were assessed for this study. Off-label TAVR was defined as TAVR in patients with known bicuspid valve, moderate aortic stenosis, severe mitral regurgitation, severe aortic regurgitation, or subaortic stenosis. Data were linked with the Centers for Medicare & Medicaid Services for 15 397 patients to evaluate 30-day and 1-year outcomes.ExposureOff-label use of TAVR.Main outcomes and measuresFrequency of off-label TAVR use and the association with in-hospital, 30-day, and 1-year adverse outcomes.ResultsAmong the 23 847 patients in the study (11 876 women and 11 971 men; median age, 84 years [interquartile range, 78-88 years]), off-label TAVR was used in 2272 patients (9.5%). In-hospital mortality was higher among patients receiving off-label TAVR than those receiving on-label TAVR (6.3% vs 4.7%; P < .001), as was 30-day mortality (8.5% vs 6.1%; P < .001) and 1-year mortality (25.6% vs 22.1%; P = .001). Adjusted 30-day mortality was higher in the off-label group (hazard ratio, 1.27; 95% CI, 1.04-1.55; P = .02), while adjusted 1-year mortality was similar in the 2 groups (hazard ratio, 1.11; 95% CI, 0.98-1.25; P = .11). The median rate of off-label TAVR use per hospital was 6.8% (range, 0%-34.7%; interquartile range, 3.4%-12.1%), with hospitals in the highest tertile of off-label use associated with increased 30-day adverse cardiovascular events compared with the lowest tertile. However, this difference was not observed in adjusted 30-day or 1-year outcomes.Conclusions and relevanceApproximately 1 in 10 patients in the United States have received TAVR for an off-label indication. After adjustment, 1-year mortality was similar in these patients to that in patients who received TAVR for an on-label indication. These results reinforce the need for additional research on the efficacy of off-label TAVR use.

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 past decade has witnessed an ever-increasing momentum of transcatheter aortic valve replacement (TAVR) and a subsequent paradigm shift in the contemporary management of severe aortic stenosis (AS). We conducted a multi-centric TAVR registry based on Chinese patients (the China Aortic valve tRanscatheter Replacement registrY [CARRY]) to delineate the clinical characteristics and outcomes of Chinese patients who underwent TAVR and compare the results between different valve types in different Chinese regions.MethodsCARRY is an all-comer registry of aortic valve disease patients undergoing TAVR across China and was designed as an observational study that retrospectively included all TAVR patients at each participating site. Seven hospitals in China participated in the CARRY, and 1204 patients from April 2012 to November 2020 were included. Categorical variables were compared using the chi-squared test, and continuous variables were analyzed using a t test or analysis of variance (ANOVA) test. The Kaplan-Meier curve was used to estimate the risk of adverse events during follow-up.ResultsThe mean age of the patients was 73.8 ± 6.5 years and 57.2% were male. The median Society of Thoracic Surgeon-Predicted Risk of Mortality score was 6.0 (3.7-8.9). Regarding the aortic valve, the proportion of bicuspid aortic valve (BAV) was 48.5%. During the hospital stay, the stroke rate was 0.7%, and the incidence of high-degree atrioventricular block indicating permanent pacemaker implantation was 11.0%. The in-hospital all-cause mortality rate was 2.2%. After 1 year, the overall mortality rate was 4.5%. Compared to patients with tricuspid aortic valve (TAV), those with BAV had similar in-hospital complication rates, but a lower incidence of in-hospital mortality (1.4% vs. 3.3%) and 1 year mortality (2.3% vs. 5.8%).ConclusionsTAVR candidates in China were younger, higher proportion of BAV, and had lower rates of post-procedural complications and mortality than other international all-comer registries. Given the use of early generation valves in the majority of the population, patients with BAV had similar rates of complications, but lower mortality than those with TAV. These findings further propel the extension of TAVR in low-risk patients.Trial registrationhttps://www.chictr.org.cn/ (No. ChiCTR2000038526).

Project description:ImportanceChronic kidney disease (CKD) is prevalent in the population of patients undergoing transcatheter aortic valve replacement (TAVR). Data on the association of TAVR with kidney function are scarce, as are data on the relationship between changes in kidney function after TAVR and mortality.ObjectiveTo describe the changes in kidney function (both periprocedural and at steady state) after TAVR and to explore the association of TAVR with midterm mortality.Design, setting, and participantsThis single-center, retrospective cohort study was conducted at a public, tertiary academic medical center, which serves as a regional referral center for valvular heart interventions. Consecutive cases of patients undergoing TAVR from November 5, 2008, to December 31, 2019, were included in the study, with available baseline and post-TAVR data on kidney function.ExposuresSteady state (1 month) change in kidney function after TAVR. Significant improvement or deterioration in renal function was defined as a greater than or equal to 10% change in estimated glomerular filtration rate (eGFR).Main outcomes and measuresOverall mortality at 2-year follow-up.ResultsA total of 894 patients (mean [SD] age, 82.2 [7.1] years; 452 women ([51.2%]) were evaluated. A total of 362 patients (40.5%) were treated from 2017 to 2019, 348 patients (38.9%) were treated from 2013 to 2016, and 184 patients (20.5%) were treated from 2008 and 2012. Patients had a mean (SD) Society of Thoracic Surgeons (STS) score of 5.2% (4.0%) and a mean (SD) eGFR of 65.1 (23.1) mL/min/1.73 m2. Acute kidney injury occurred in 115 (11.1%) patients by 48 hours, of whom 73 (63.5%) resolved by discharge. One month after TAVR, eGFR improved by at least 10% in 329 patients (36.8%) and deteriorated by at least 10% in 233 patients (26.1%). Overall, CKD stage remained stable or improved in 720 patients (80.6%), and only 5 patients (0.97%) progressed to stage 5 CKD 1 month after TAVR. A deterioration of 10% or greater in eGFR 1 month after TAVR was associated with a hazard ratio of 2.16 (95% CI, 1.24-5.24; P = .04) at 2-year mortality. Patients who showed CKD status resolution (eGFR improvement to >60 mL/min/1.73 m2 after TAVR) had a similar 2-year mortality to those with baseline eGFR greater than 60 mL/min/1.73 m2 and vice versa. Factors associated with steady state CKD status resolution after TAVR included lower STS score, higher left ventricular ejection fraction, higher baseline eGFR, no acute kidney injury at discharge from the TAVR admission, and lower contrast-eGFR ratio.Conclusions and relevanceIn this cohort study, kidney outcomes after TAVR were reassuring; greater than 80% of patients showed stable or improved kidney function 1 month after the procedure. Improvement in kidney function was associated with a lower 2-year mortality, whereas deterioration in kidney function was associated with increased mortality. Our data suggest that cardiorenal syndrome was a possible cause of CKD in patients in need of TAVR and that there was potential for improvement in both renal and cardiac function after this procedure.

Dataset Information

A Risk Model for 1-Year Mortality After Transcatheter Aortic Valve Replacement From the J-TVT Registry.

Background

Objectives

Methods

Results

Conclusions

Publications

A Risk Model for 1-Year Mortality After Transcatheter Aortic Valve Replacement From the J-TVT Registry.

Similar Datasets

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