Calculated plasma volume status and outcomes in patients undergoing transcatheter aortic valve replacement.
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ABSTRACT: Aims
This study investigated the prognostic value of plasma volume status (PVS) in patients who underwent transcatheter aortic valve replacement (TAVR).Methods and results
Plasma volume status was calculated in 2588 patients who underwent TAVR using data from the Japanese multicentre registry. All-cause mortality and heart failure hospitalization (HFH) within 2 years of TAVR were compared among the PVS quartiles (Q1, PVS < 5.5%; Q2, PVS 5.5-13.5%; Q3, PVS 13.5-21.0%; and Q4, PVS ≥ 21.0%). Subgroups were stratified by the PVS cut-off value combined with the New York Heart Association (NYHA) class as follows: low PVS with NYHA I/II (n = 959), low PVS with NYHA III/IV (n = 845), high PVS with NYHA I/II (n = 308), and high PVS with NYHA III/IV (n = 476). The cumulative all-cause mortality and HFH within 2 years of TAVR significantly increased with increasing PVS quartiles [8.5%, 16.8%, 19.2%, and 27.0% (P < 0.001) and 5.8%, 8.7%, 10.3%, and 12.9% (P < 0.001), respectively]. The high-PVS group regardless of the NYHA class had a higher all-cause mortality and HFH [9.6%, 18.2%, 24.5%, and 30.4% (P < 0.001) and 6.1%, 10.4%, 14.1%, and 11.3% (P < 0.001)]. In a Cox regression multivariate analysis, the PVS values of Q3 and Q4 had independently increased all-cause mortality [hazard ratio (HR), 1.50 and 1.64 (P = 0.017 and P = 0.008), respectively], and Q4 had independently increased HFH (HR, 1.98, P = 0.005). The low PVS with NYHA III/IV, high PVS with NYHA I/II, and high PVS with NYHA III/IV also had significantly increased all-cause mortality [HR, 1.45, 1.73, and 1.86 (P = 0.006, P = 0.002, and P < 0.001), respectively] and HFH [HR, 1.52, 2.21, and 1.70 (P = 0.049, P = 0.002, and P = 0.031), respectively].Conclusions
Plasma volume status is useful for predicting all-cause mortality and HFH after TAVR.
SUBMITTER: Shimura T
PROVIDER: S-EPMC8120354 | biostudies-literature |
REPOSITORIES: biostudies-literature
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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:ObjectiveThe utilization of transcatheter aortic valve replacement (TAVR) technology has exceeded that of traditional surgical aortic valve replacement (SAVR). In addition, the role of minimum surgical volume requirements for TAVR centers has recently been disputed. The present work evaluated the association of annual institutional SAVR caseload on outcomes following TAVR.MethodsThe 2012-2018 Nationwide Readmissions Database was queried for elective TAVR hospitalizations. The study cohort was split into early (Era 1: 2012-2015) and late (Era 2: 2016-2018) groups. Based on restricted cubic spline modeling of annual hospital SAVR caseload, institutions were dichotomized into low-volume and high-volume centers. Multivariable regressions were used to determine the influence of high-volume status on in-hospital mortality and perioperative complications following TAVR.ResultsAn estimated 181,740 patients underwent TAVR from 2012 to 2018. Nationwide TAVR volume increased from 5893 in 2012 to 49,983 in 2018. After adjustment for relevant patient and hospital factors, high-volume status did not alter odds of TAVR mortality in Era 1 (adjusted odds ratio, 0.94; P = .52) but was associated decreased likelihood of mortality in Era 2 (adjusted odds ratio, 0.83; P = .047). High-volume status did not influence the risk of perioperative complications during Era 1. However, during Era 2, patients at high-volume centers had significantly lower odds of infectious complications, relative to low-volume hospitals (adjusted odds ratio, 0.78; P = .002).ConclusionsSAVR experience is associated with improved TAVR outcomes in a modern cohort. Our findings suggest the need for continued collaboration between cardiologists and surgeons to maximize patient safety.
| S-EPMC9510825 | biostudies-literature
Project description:ObjectivesThe aim of this study was to assess the association of baseline left ventricular diastolic dysfunction (LVDD) with health status outcomes of patients undergoing transcatheter aortic valve replacement (TAVR).BackgroundAlthough LVDD in patients with aortic stenosis is associated with higher mortality after TAVR, it is unknown if it is also associated with health status recovery.MethodsIn a cohort of 304 patients with interpretable echocardiograms, undergoing TAVR, LVDD was categorized at baseline as absent (grade 0), mild (grade 1), moderate (grade 2), or severe (grade 3). Disease-specific health status was assessed using the 12-item Kansas City Cardiomyopathy Questionnaire overall summary score (KCCQ-OS) at baseline and at 1-month and 12-month follow-up. Association of baseline LVDD with health status at baseline and follow-up after TAVR was assessed using a linear trend test, and association with health status recovery (change in KCCQ-OS) was examined using a linear mixed model adjusting for baseline KCCQ-OS.ResultsTwenty-four (7.9%), 54 (17.8%), 186 (61.2%), and 40 (13.2%) patients had LVDD grades of 0, 1, 2, and 3, respectively. Baseline KCCQ-OS was 61.3 ± 22.7, 51.0 ± 26.1, 44.7 ± 25.7, and 44.4 ± 21.9 (p = 0.004) in patients with LVDD grades of 0, 1,2 and 3. At 1 and 12 months after TAVR, LVDD was not associated with KCCQ-OS. Recovery in KCCQ-OS after TAVR was substantial and similar in patients across all severities of LVDD.ConclusionsAlthough LVDD is associated with health status prior to TAVR, patients across all severities of LVDD have similar recovery in health status after TAVR.
| S-EPMC6925353 | biostudies-literature
Project description:BackgroundMalnutrition is associated with adverse outcomes in patients with aortic stenosis. The Triglycerides × Total Cholesterol × Body Weight Index (TCBI) is a simple scoring model to evaluate the status of nutrition. However, the prognostic relevance of this index in patients undergoing transcatheter aortic valve replacement (TAVR) is unknown. This study aimed to evaluate the association of the TCBI with clinical outcomes in patients undergoing TAVR.MethodsA total of 1377 patients undergoing TAVR were evaluated in this study. The TCBI was calculated by the formula; triglyceride (mg/dL) × total cholesterol (mg/dL) × body weight (kg)/1000. The primary outcome was all-cause mortality within 3 years.ResultsPatients with a low TCBI, based on a cut-off value of 985.3, were more likely to have elevated right atrial pressure (p = 0.04), elevated right ventricular pressure (p < 0.01), right ventricular systolic dysfunction (p < 0.01), tricuspid regurgitation ≥ moderate (p < 0.01). Patients with a low TCBI had a higher cumulative 3-year all-cause (42.3% vs. 31.6%, p < 0.01; adjusted HR 1.36, 95% CI 1.05-1.77, p = 0.02) and non-cardiovascular mortality (15.5% vs. 9.1%, p < 0.01; adjusted HR 1.95, 95% CI 1.22-3.13, p < 0.01) compared to those with a high TCBI. Adding a low TCBI to EuroSCORE II improved the predictive value for 3-year all-cause mortality (net reclassification improvement, 0.179, p < 0.01; integrated discrimination improvement, 0.005, p = 0.01).ConclusionPatients with a low TCBI were more likely to have right-sided heart overload and exhibited an increased risk of 3-year mortality. The TCBI may provide additional information for risk stratification in patients undergoing TAVR.
| S-EPMC10808226 | biostudies-literature
Project description:Background There was limited high-quality evidence that illuminated the efficiency of cerebral embolic protection (CEP) use during transcatheter aortic valve replacement (TAVR) for bicuspid aortic valve (BAV) stenosis. Methods and Results In this retrospective cohort study, patients with BAV stenosis undergoing TAVR with or without CEP were identified by querying the National Inpatient Sample database. The primary end point was any stroke during the hospitalization. The composite safety end point included any in-hospital death and stroke. We applied propensity score-matched analysis to minimize standardized mean differences of baseline variables and compare in-hospital outcomes. From July 2017 to December 2020, 4610 weighted hospitalizations with BAV stenosis undergoing TAVR were identified, of which 795 were treated with CEP. There was a significant increase in the CEP use rate for BAV stenosis (P-trend <0.001). A total of 795 discharges with CEP use were propensity score matched to 1590 comparable discharges but without CEP. CEP use was associated with a lower incidence of in-hospital stroke (1.3% versus 3.8%; P<0.001), which in multivariable regression was also independently associated with the primary outcome (adjusted odds ratio=0.38 [95% CI, 0.18-0.71]; P=0.005) and the safety end point (adjusted odds ratio=0.41 [95% CI, 0.22-0.68] P=0.001). Meanwhile, no significant difference was found in the cost of hospitalization ($46 629 versus $45 147; P=0.18) or the risk of vascular complications (1.9% versus 2.5%; P=0.41). Conclusions This observational study supported CEP use for BAV stenosis, which was independently associated with less in-hospital stroke without burdening the patients with a high hospitalization cost.
| S-EPMC10356028 | biostudies-literature
Project description:BackgroundBaseline left ventricular diastolic dysfunction (LVDD) is associated with poor health status in patients with severe aortic stenosis undergoing transcatheter aortic valve replacement (TAVR), but health status improvement after TAVR appears similar across all grades of LVDD. Here, we aim to examine the relationship between changes in LVDD severity and health status outcomes following TAVR.MethodsPatients who underwent TAVR and had evaluable LVDD at both baseline and 1 year in the PARTNER (Placement of Aortic Transcatheter Valves) 2 SAPIEN 3 registries and PARTNER 3 trial were analyzed. LVDD grade was evaluated using echocardiography core lab data and an adapted definition of American Society of Echocardiography guidelines. Health status was assessed using the Kansas City Cardiomyopathy Questionnaire Overall Summary (KCCQ-OS) score. The association between ΔLVDD severity and ΔKCCQ-OS was examined using linear regression models adjusted for baseline KCCQ-OS.ResultsOf 1100 patients, 724 (65.8%), 283 (25.7%), and 93 (8.5%) had grade 0/1, 2, and 3 LVDD at baseline, respectively. At 1 year, LVDD severity was unchanged in 790 (71.8%) patients, improved in 189 (17.2%), and worsened in 121 (11.0%). Among 376 patients with baseline grade 2 or 3 LVDD, 50.3% had improvement in LVDD. In the overall cohort, KCCQ-OS score improved by 21.9 points at 1 year. There was a statistically significant association between change in LVDD severity (improved, unchanged, and worsened) and ΔKCCQ-OS at 1 year (p = 0.007).ConclusionsChange in LVDD grade was associated with change in health status 1 year following TAVR.
| S-EPMC10818150 | biostudies-literature
Project description:BackgroundTranscatheter aortic valve replacement (TAVR) represents a disruptive technology that is rapidly expanding in use. We evaluated the effect on surgical aortic valve replacement (SAVR) patient selection, outcomes, volume, and cost.MethodsA total of 11,565 patients who underwent SAVR, with or without coronary artery bypass grafting (2002 to 2015), were evaluated from the Virginia Cardiac Services Quality Initiative database. Patients were stratified by surgical era: pre-TAVR era (2002 to 2008, n = 5,113), early-TAVR era (2009 to 2011, n = 2,709), and commercial-TAVR era (2012 to 2015, n = 3,743). Patient characteristics, outcomes, and resource utilization were analyzed by univariate analyses.ResultsThroughout the study period, statewide SAVR volumes increased with median volumes of pre-TAVR: 722 cases/year, early-TAVR: 892 cases/year, and commercial-TAVR: 940 cases/year (p = 0.005). Implementation of TAVR was associated with declining Society of Thoracic Surgeons predicted risk of mortality among SAVR patients (3.7%, 2.6%, and 2.4%; p < 0.0001), despite increasing rates of comorbid disease. The mortality rate was lowest in the current commercial-TAVR era (3.9%, 4.3%, and 3.2%; p = 0.05), and major morbidity decreased throughout the time period (21.2%, 20.5%, and 15.2%; p < 0.0001). The lowest observed-to-expected ratios for both occurred in the commercial-TAVR era (0.9 and 0.9, respectively). Resource utilization increased generally, including total cost increases from $42,835 to $51,923 to $54,710 (p < 0.0001).ConclusionsAt present, SAVR volumes have not been affected by the introduction of TAVR. The outcomes for SAVR continue to improve, potentially due to availability of transcatheter options for high-risk patients. Despite rising costs for SAVR, open approaches still provide a significant cost advantage over TAVR.
| S-EPMC5596915 | 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:Background While there is evidence that patients with low-flow, low-gradient aortic stenosis (AS) benefit from transcatheter aortic valve replacement (TAVR), data are lacking regarding outcomes of patients with a very low gradient (VLG). Methods In this retrospective, single-center study of patients with severe AS who underwent TAVR, three groups were defined using baseline mean aortic valve gradient: VLG (≤25 mmHg), low gradient (LG, 26–39 mmHg), and high gradient (HG, ≥40 mmHg). The primary outcome was the composite of Kansas City Cardiomyopathy Questionnaire (KCCQ)-12 of <45, decrease in KCCQ-12 of ≥10 compared with baseline, or death at 1 year. Results One-thousand six patients were included: 571 HG, 353 LG, and 82 VLG. The median age was 82.1 years [interquartile range (IQR) 76.3–86.9]; VLG patients had more baseline comorbidities compared with the other groups. The primary outcome was highest at 1 year in the VLG group (VLG, 46.7%; LG, 29.9%; HG, 23.1%; p = 0.002), with no difference between groups after adjustment for baseline characteristics. At baseline, <30% of VLG patients had an excellent or good (50–100) KCCQ-12, whereas more than 75% and 50% had an excellent or good KCCQ-12 at 30-day and 1-year follow-up, respectively. Conclusion Although patients with VLG undergoing TAVR have a higher rate of poor outcomes at 1 year compared with patients with LG and HG severe AS, this difference is largely attributable to baseline comorbidities. Patients with severe AS undergoing TAVR have significant improvement in health status outcomes regardless of resting mean gradient.
| S-EPMC10436597 | biostudies-literature
Project description:BackgroundAlthough Arm circumference (AC) is considered to be a predictor of clinical outcomes of transcatheter aortic valve replacement (TAVR), limited data are available on the impact of this anthropometric measurement. This study aimed to investigate the clinical impact of AC on the outcomes of patients who underwent TAVR.MethodsAC was investigated in consecutive patients who underwent TAVR between March 2014 and May 2018. Patients were divided into low AC (n = 220) and high AC (n = 127) groups by a classification and regression tree (CART) survival model, and their baseline characteristics and mortality were compared. The correlations of AC with other frailty markers were also evaluated.ResultsOne-year clinical follow-up was completed in 100% of cases, and 89 patients (31 men, 58 women) died during the median follow-up period of 825 days. The low AC group was more fragile than the high AC group, and the AC value was significantly correlated with each frailty marker (all p < 0.05). The Cox regression analysis demonstrated the independent association of mortality with low AC (HR: 2.56, 95% confidence interval [CI]: 1.47-4.46, p < 0.001). When AC was compared to conventional prediction models of survival, the net reclassification improvement and the integrated discrimination improvement analysis showed significant improvements in predicting outcomes after including the AC with other frailty markers (all p < 0.05).ConclusionsThe AC is related to frailty markers and is an important surrogate marker for predicting worse clinical outcomes after TAVR. Assessment of AC may be considered when deciding on TAVR.
| S-EPMC9118512 | biostudies-literature