Contemporary trends and outcomes in aortic valve replacement in patients with end-stage liver disease.
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ABSTRACT: Objective
Even in high-risk trials pertaining to transcatheter aortic valve replacement (TAVR), patients with end-stage liver disease (ESLD) have been under-represented. We sought to study this population group from a large national United States population database.Methods
We used National Inpatient Sample (NIS) database from January 2005 to August 2015. Patients with ESLD were extracted using Goldberg's algorithm. Propensity match analysis was done for comparative analysis between surgical aortic valve replacement (SAVR) and TAVR groups. Logistic regression analysis was used for predictors of in-hospital mortality.Results
Out of 309,959 ESLD patients, 1,375 underwent aortic valve replacement and 1,199 patients were included in our study. Mean age was 66.1 (SD, 9.1) years. In matched data, the in-hospital mortality was 5.5% in TAVR group when compared to 19.4% in SAVR group. Ventilator use (16.1 vs. 27.2%, p < .01), tracheostomy (<4 vs. 7.2%, p < .01), and vasopressin use (0 vs. 7.4%, p < .01) were utilized less in TAVR group as compared to SAVR group. The proportion of TAVR has increased from almost zero in 2011 to 51.3% in 2015. Mean cost for hospital stay has increased in SAVR group (from 254,427$ in 2005 to 321,791$ in 2015, p < .01). Similarly, a large decrease in length of stay has been observed for TAVR group (14.5 days in 2011 to 5.4 days in 2015, p < .01). TAVR (odds ratios [OR]: 0.42, 95% confidence interval [CI]: 0.20-0.87, p = .02) was associated with lower in-hospital mortality.Conclusion
TAVR was associated with lower in-hospital mortality, morbidity, and resource utilization in high-risk ESLD patients.
SUBMITTER: Khan MZ
PROVIDER: S-EPMC7484033 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:Background Aortic stenosis is prevalent in end-stage renal disease. Transcatheter aortic valve replacement (TAVR) is a plausible alternative for surgical aortic valve replacement. However, little is known regarding long-term outcomes in patients with end-stage renal disease who undergo TAVR. Methods and Results We identified all patients with end-stage renal disease who underwent TAVR from 2011 through 2016 using the United States Renal Data System. The primary end point was 5-year mortality after TAVR. Factors associated with 1- and 5-year mortality were analyzed. A total of 3883 TAVRs were performed for patients with end-stage renal disease. Mortality was 5.8%, 43.7%, and 88.8% at 30 days, 1 year, and 5 years, respectively. Case volumes increased rapidly from 17 in 2011 to 1495 in 2016. Thirty-day mortality demonstrated a dramatic reduction from 11.1% in 2012 to 2.5% in 2016 (P=0.01). Age 75 or older (hazard ratio [HR], 1.14; 95% CI, 1.05-1.23 [P=0.002]), body mass index <25 (HR, 1.18; 95% CI, 1.08-1.28 [P<0.001]), chronic obstructive pulmonary disease (HR, 1.25; 95% CI, 1.1-1.35 [P<0.001]), diabetes mellitus as the cause of dialysis (HR, 1.22; 95% CI, 1.11-1.35 [P<0.001]), hypertension as the cause of dialysis (HR, 1.17; 95% CI, 1.06-1.29 [P=0.004]), and White race (HR, 1.17; 95% CI, 1.06-1.3 [P=0.002]) were independently associated with 5-year mortality. Conclusions Short-term outcomes of TAVR in patients with end-stage renal disease have improved significantly. However, long-term mortality of patients on dialysis remains high.
| S-EPMC8475055 | biostudies-literature
Project description:Background Patients with cancer and severe aortic stenosis are often ineligible for surgical aortic valve replacement (SAVR). Patients with cancer may likely benefit from emerging transcatheter aortic valve replacement (TAVR), given its minimally invasive nature. Methods and Results The US-based National Inpatient Sample was queried between 2012 and 2015 using International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM), codes to identify all hospitalized adults (aged ?50 years), who had a primary diagnosis of aortic stenosis. We examined the effect modification of cancer on the relative use rate, outcomes, and dispositions associated with propensity-matched cohort TAVR versus SAVR. Overall, 47 295 TAVRs (22.6% comorbid cancer) and 113 405 SAVRs (15.2% comorbid cancer) were performed among admissions with aortic stenosis between 2012 and 2015. In the year 2015, patients with cancer saw relatively higher rates of TAVR use compared with SAVR (relative use rateTAVR versus relative use rateSAVR, 67.8% versus 57.2%; P<0.0001). Among patients with cancer, TAVR was associated with lower odds of acute kidney injury (odds ratio, 0.64; 95% CI, 0.54-0.75) and major bleeding (odds ratio, 0.44; 95% CI, 0.38-0.51]), with no differences in in-hospital mortality and stroke compared with SAVR. In addition, TAVR was associated with higher odds of home discharge (odds ratio, 1.92; 95% CI, 1.68-2.19) compared with SAVR among patients with cancer. Lower risk of acute kidney injury was noted in cancer versus noncancer (P<0.001) undergoing TAVR versus SAVR in effect modification analysis. Conclusions TAVR use has increased irrespective of cancer status, with a greater increase in cancer versus noncancer. In patients with cancer, there was an association of TAVR with lower periprocedural complications and better disposition when compared with patients undergoing SAVR.
| S-EPMC7033818 | biostudies-literature
Project description:AimsWe sought to perform a head-to-head comparison of contemporary 30-day outcomes and readmissions between valve-in-valve transcatheter aortic valve replacement (VIV-TAVR) patients and a matched cohort of high-risk reoperative surgical aortic valve replacement (re-SAVR) patients using a large, multicentre, national database.Methods and resultsWe utilized the nationally weighted 2012-16 National Readmission Database claims to identify all US adult patients with degenerated bioprosthetic aortic valves who underwent either VIV-TAVR (n = 3443) or isolated re-SAVR (n = 3372). Thirty-day outcomes were compared using multivariate analysis and propensity score matching (1:1). Unadjusted, VIV-TAVR patients had significantly lower 30-day mortality (2.7% vs. 5.0%), 30-day morbidity (66.4% vs. 79%), and rates of major bleeding (35.8% vs. 50%). On multivariable analysis, re-SAVR was a significant risk factor for both 30-day mortality [adjusted odds ratio (aOR) of VIV-SAVR (vs. re-SAVR) 0.48, 95% confidence interval (CI) 0.28-0.81] and 30-day morbidity [aOR for VIV-TAVR (vs. re-SAVR) 0.54, 95% CI 0.43-0.68]. After matching (n = 2181 matched pairs), VIV-TAVR was associated with lower odds of 30-day mortality (OR 0.41, 95% CI 0.23-0.74), 30-day morbidity (OR 0.53, 95% CI 0.43-0.72), and major bleeding (OR 0.66, 95% CI 0.51-0.85). Valve-in-valve TAVR was also associated with shorter length of stay (median savings of 2 days, 95% CI 1.3-2.7) and higher odds of routine home discharges (OR 2.11, 95% CI 1.61-2.78) compared to re-SAVR.ConclusionIn this large, nationwide study of matched high-risk patients with degenerated bioprosthetic aortic valves, VIV-TAVR appears to confer an advantage over re-SAVR in terms of 30-day mortality, morbidity, and bleeding complications. Further studies are warranted to benchmark in low- and intermediate-risk patients and to adequately assess longer-term efficacy.
| S-EPMC7395321 | biostudies-literature
Project description:Background Contemporary outcomes of transcatheter aortic valve replacement (TAVR) in nonagenarians are unknown. Methods and Results We identified 13 544 nonagenarians (aged 90-100 years) who underwent TAVR between 2012 and 2016 using Medicare claims. Generalized estimating equations were used to study the change in short-term outcomes among nonagenarians over time. We compared outcomes between nonagenarians and non-nonagenarians undergoing TAVR in 2016. A mixed-effect multivariable logistic regression was performed to determine predictors of 30-day mortality in nonagenarians in 2016. A center was defined as a high-volume center if it performed ≥100 TAVR procedures per year. After adjusting for changes in patients' characteristics, risk-adjusted 30-day mortality declined in nonagenarians from 9.8% in 2012 to 4.4% in 2016 (P<0.001), whereas mortality for patients <90 years decreased from 6.4% to 3.5%. In 2016, 35 712 TAVR procedures were performed, of which 12.7% were in nonagenarians. Overall, in-hospital mortality in 2016 was higher in nonagenarians compared with younger patients (2.4% versus 1.7%, P<0.05) but did not differ in analysis limited to high-volume centers (2.2% versus 1.7%; odds ratio: 1.33; 95% CI, 0.97-1.81; P=0.07). Important predictors of 30-day mortality in nonagenarians included in-hospital stroke (adjusted odds ratio [aOR]: 8.67; 95% CI, 5.03-15.00), acute kidney injury (aOR: 4.11; 95% CI, 2.90-5.83), blood transfusion (aOR: 2.66; 95% CI, 1.81-3.90), respiratory complications (aOR: 2.96; 95% CI, 1.52-5.76), heart failure (aOR: 1.86; 95% CI, 1.04-3.34), coagulopathy (aOR: 1.59; 95% CI, 1.12-2.26; P<0.05 for all). Conclusions Short-term outcomes after TAVR have improved in nonagenarians. Several procedural complications were associated with increased 30-day mortality among nonagenarians.
| S-EPMC6898796 | biostudies-literature
Project description:Although the results of the early TAVI experience are promising, longer-term follow-up is necessary before the procedure can be extended to lowerrisk patients. Many issues are not yet resolved, including the long-term effects of paravalvular leaks (which occur in most TAVI patients), the true stroke rate in TAVI patients (which is probably in the range of 5% to 6%), and the need for permanent pacemaker implantation (which ranges from 5% to 40% in TAVI patients, depending upon the device used). As the procedure is extended into the lower-risk population, these issues will assume greater import than they have in the population currently in treatment—very elderly, high-risk patients with limited life expectancy. As in the coronary-revascularization paradigm of percutaneous coronary intervention versus coronary artery bypass grafting, there will be increasing adoption of the transcatheter approach. Just as the rumors of the demise of surgical bypass were premature, conventional AVR will continue to be the predominant technique for the treatment of aortic stenosis during at least the next decade. Although the percentage of patients treated by a transcatheter approach will continue to increase, regulatory and reimbursement factors are likely to be the primary determinants of the rate of adoption.
| S-EPMC3014148 | biostudies-other
Project description:ImportanceThe Centers for Medicare & Medicaid Services national coverage determination for transcatheter aortic valve replacement (TAVR) includes volume requirements for surgical aortic valve replacement (SAVR) for hospitals seeking to initiate or continue TAVR programs. Evidence regarding the association between SAVR volume and TAVR outcomes is limited.ObjectiveTo examine the association of hospital SAVR and combined SAVR and TAVR volumes with patient outcomes of TAVR procedures performed within 1 year, 2 years, and for the entire period after initiation of TAVR programs.Design, setting, and participantsThis observational cohort study included 60 538 TAVR procedures performed in 438 hospitals between October 1, 2011, and December 31, 2015, among Medicare beneficiaries.Main outcomes and measuresThe associations between SAVR volume, SAVR and TAVR volumes, and risks of death, death or stroke, and readmissions within 30 days were determined using a hierarchical logistic regression model adjusting for patient and hospital characteristics. The association between SAVR and SAVR and TAVR volumes and 1-year and 2-year mortality after TAVR procedures was determined using a multivariable proportional hazard model with a robust variance estimator. The associations for procedures performed within 1 year, 2 years, and for the entire period after initiation of TAVR programs were examined.ResultsAmong the 60 538 patients, 29 173 were women and 31 365 were men, with a mean (SD) age of 82.3 (8.0) years. Hospitals with high SAVR volume (mean annual volume, ≥97 per year) were more likely to adopt TAVR early and had a higher growth in TAVR volumes over time (median TAVR volume by hospitals with high SAVR volume and low SAVR volume: year 1, 32 vs 19; year 2, 48 vs 28; year 3, 82 vs 38; year 4, 118 vs 54; P < .001). In adjusted analysis, high hospital SAVR volume alone was not associated with better patient outcomes after TAVR. When hospital TAVR and SAVR volumes were jointly analyzed, patients treated in hospitals with high TAVR volume had lower 30-day mortality after TAVR (high TAVR and low SAVR vs low TAVR and low SAVR: odds ratio, 0.85; 95% CI, 0.72-0.99; high TAVR and high SAVR vs low TAVR and high SAVR: odds ratio, 0.81; 95% CI, 0.69-0.95), the effect of which was more pronounced when hospitals also had high SAVR volume. Patients treated in hospitals with high SAVR volume and high TAVR volume had the lowest 30-day mortality (vs hospitals with low SAVR volume and TAVR volume: odds ratio, 0.77; 95% CI, 0.66-0.89).Conclusions and relevanceHospitals with high SAVR volume are most likely to be fast adopters of TAVR. Hospital SAVR volume alone is not associated with better TAVR outcomes. Accumulating high volumes of TAVR is associated with lower mortality after TAVR, particularly when hospitals have high SAVR volumes. Hospitals with high caseloads of both SAVR and TAVR are likely to achieve the best outcomes.
| S-EPMC6583695 | biostudies-literature
Project description:The study sought to contrast risk profiles and compare outcomes of patients with severe aortic stenosis (AS) and coronary artery disease (CAD) who underwent aortic valve replacement (AVR) and coronary artery bypass grafting (AS+CABG) with those of patients with isolated AS who underwent AVR alone.In patients with severe AS, CAD is often an incidental finding with underappreciated survival implications.From October 1991 to July 2010, 2,286 patients underwent AVR+CABG and 1,637 AVR alone. A propensity score was developed and used for matched comparisons of outcomes (1,082 patient pairs). Analyses of long-term mortality were performed for each group, then combined to identify common and unique risk factors.Patients with AS+CAD versus isolated AS were older, more symptomatic, and more likely to be hypertensive, and had lower ejection fraction and greater arteriosclerotic burden but less severe AS. Hospital morbidity and long-term survival were poorer (43% vs. 59% at 10 years). Both groups shared many mortality risk factors; however, early risk among AS+CAD patients reflected effects of CAD; late risk reflected diastolic left ventricular dysfunction expressed as ventricular hypertrophy and left atrial enlargement. Patients with isolated AS and few comorbidities had the best outcome, those with CAD without myocardial damage had intermediate outcome equivalent to propensity-matched isolated AS patients, and those with CAD, myocardial damage, and advanced comorbidities had the worst outcome.Cardiovascular risk factors and comorbidities must be considered in managing patients with severe AS. Patients with severe AS and CAD risk factors should undergo early diagnostics and AVR+CABG before ischemic myocardial damage occurs.
| S-EPMC4262244 | biostudies-literature
Project description:ObjectiveTo identify outcomes of patients undergoing emergency transcatheter aortic valve replacement (TAVR) and determine predictors of in-hospital mortality.BackgroundEmergency TAVR has emerged as a viable treatment strategy for patients with decompensated severe aortic stenosis and/or regurgitation; however, data on patients undergoing emergency TAVR are limited.MethodsAll emergency TAVR procedures were identified from a single tertiary academic center between January 2015 and August 2018.Results31 patients underwent emergency TAVR due to cardiogenic shock (26 patients), electrical instability with incessant ventricular tachycardia (2 patients), severe refractory angina (2 patients), and decompensated heart failure with hypoxemic respiratory failure requiring mechanical ventilation (1 patient). Mechanical circulatory support (MCS) was used in 16 (51.6%). MCS initiation occurred immediately prior to TAVR in 10 patients and placed post-TAVR in 6 patients. 6 patients died before hospital discharge (in-hospital mortality 19.4%). 1-year and 2-year survival rates were 61.0% and 55.9%, respectively. Univariate predictors of in-hospital mortality were preprocedural pulmonary artery pulsatility index (PAPi) ≤1.8 (66.7% vs. 20.0%, p=0.01), intraprocedural cardiopulmonary resuscitation (CPR) (83.3% vs 4.0%, p ≤ 0.001), acute kidney injury post-TAVR (80.0% vs. 4.2%, p ≤ 0.001), initiation of dialysis post-TAVR (60.0% vs. 4.2%, p ≤ 0.001), and MCS initiation post-TAVR (50.0% vs. 12.0%, p=0.03). MCS initiation before TAVR was associated with improved survival compared with post-TAVR initiation.ConclusionEmergency TAVR in extreme risk patients with acute decompensated heart failure or cardiogenic shock secondary to severe aortic valve disease is associated with high in-hospital mortality rates. Careful patient selection taking into account right heart function, assessed by PAPi, and early utilization of MCS may improve survival following emergency TAVR.
| S-EPMC6875395 | biostudies-literature
Project description:ObjectiveIn patients with mild to moderate operative risk, surgical aortic valve replacement (SAVR) is still the preferred treatment for patients with severe symptomatic aortic stenosis (AS). Aiming to broaden the knowledge of postsurgical outcomes, this study reports a broad set of morbidity outcomes following surgical intervention.MethodsOur cohort comprised 442 patients referred for severe AS; 351 had undergone SAVR, with the remainder (91) not operated on. All patients were evaluated using the 6-minute walk test (6MWT), were assigned a New York Heart Association class (NYHA) and Canadian Cardiovascular Society class (CCS), with additional scores for health-related quality of life (HRQoL), cognitive function (Mini-Mental State Examination (MMSE)) and myocardial remodelling (at inclusion and at 1-year follow-up). Adverse events and mortality were recorded.ResultsThree-year survival after SAVR was 90.0%. SAVR was associated with an improved NYHA class, CCS score and HRQoL, and provoked reverse ventricular remodelling. The 6MWT decreased, while the risks of major adverse cardiovascular events (death, non-fatal stroke/transient ischaemic attack or myocardial infarction) and all-cause hospitalisation (incidence rate per 100 patient-years) were 13.5 and 62.4, respectively. The proportion of cognitive disability measured by MMSE increased after SAVR from 3.2% to 8.8% (p=0.005). Proportion of patients living independently at home, having attained NYHA class I, was met by 49.1% at 1 year. Unoperated individuals had a poor prognosis in terms of any outcome.ConclusionThis study provides knowledge of outcomes beyond what is known about the mortality benefit after SAVR to provide insight into the morbidity burden of modern-day SAVR.
| S-EPMC5471875 | biostudies-literature
Project description:BACKGROUND:Two large, randomized trials are underway evaluating transcatheter aortic valve replacement (AVR) against conventional surgical AVR. We analyzed contemporary, real-world outcomes of surgical AVR in low-risk patients to provide a practical benchmark of outcomes and cost for evaluating current and future transapical AVR technology. METHODS:From 2010 to 2015, 2,505 isolated AVR operations were performed for severe aortic stenosis at 18 statewide cardiac institutions. Of these, 2,138 patients had a Society of Thoracic Surgeons predicted risk of mortality of less than 4%, and 1,119 met other clinical and hemodynamic criteria as outlined in the PARTNER 3 (The Placement of Transcatheter Aortic Valves) protocol. Patients with endocarditis, end-stage renal disease, ejection fraction of less than 0.45, bicuspid valves, and previous valve replacements were excluded. Outcomes of interest included operative death and postoperative adverse events. RESULTS:The median Society of Thoracic Surgeons predicted risk of mortality for the study-eligible patients was 1.44%, with a median age of 72 years (interquartile range [IQR], 65 to 78 years). Operative mortality was 1.3%, permanent stroke was 1.3%, and pacemaker requirement was 4.2%. The most common adverse events were transfusion of 2 or more units of red blood cells (18%) and atrial fibrillation (28%). The median length of stay was 6 days (IQR, 5 to 8 days). Median total hospital cost was $37,999 (IQR, $30,671 to $46,138). Examination of complications by age younger than 65 vs 65 or older demonstrated a significantly lower need for transfusion (11.2%, p < 0.001) and incidence of atrial fibrillation (17.1%, p < 0.001) but no difference in operative mortality (2.2% vs 0.9%, p = 0.1), major morbidity (10.4% vs 12.6%, p = 0.3), or total hospital costs. CONCLUSIONS:Low-risk patients undergoing surgical AVR in the current era have excellent results. The most common complications were atrial fibrillation and bleeding. These real-world results should provide additional context for upcoming transcatheter clinical trial data.
| S-EPMC5610058 | biostudies-other