Mortality In Transcatheter Aortic Valve Replacement Research Articles

Abstract 15595: In-Hospital Outcomes in Patients With Psoriasis Who Undergo Transcatheter Aortic Valve Replacement

Background Psoriasis is a chronic inflammatory condition associated with an increased prevalence of aortic stenosis (AS). There is paucity of evidence regarding transcatheter aortic valve replacement (TAVR) outcomes in patients with psoriasis. Methods: The National Inpatient Sample Database was queried from 2016-2019 for relevant ICD-10 diagnostic and procedural codes. Beeline characteristics and in-hospital TAVR outcomes were compared in patients with and without psoriasis. Multivariate logistic regression was performed for select outcomes to adjust for differences in baseline characteristics. A p value <0.05 was considered significant. Results: 227,920 hospitalizations for TAVR were identified of which 1,510 (0.6%) were patients with psoriasis. See Table 1 for baseline characteristics. Patients with psoriasis were more likely to be white, and have concurrent diagnoses of hypertension, diabetes mellitus, hyperlipidemia, coronary artery disease, obesity, tobacco use disorder, COPD, and thrombocytopenia. Adjusting for baseline characteristics, those with psoriasis were found to have higher rates of in-hospital all-cause mortality OR 2.20 [1.57-3.09], and major bleeding events OR 1.38 [1.13-1.69]. Conclusions: Psoriasis is associated with worse outcomes and higher in-hospital mortality in TAVR. Further studies are warranted to optimize outcomes in this higher risk cohort. Table 1. Patient Characteristics. Values are reported as mean ± standard deviation or median [interquartile range] for continuous variables. Categorical variables are represented as n (%). Between-group comparisons were performed for continuous data using T-test for parametric and Mann-Whitney U test for nonparametric variables, respectively. Categorical variables were compared using Chi squared test. A p-value <0.05 was considered significant (bold).

Abstract 15819: The Outcome of Transcatheter Aortic Valve Replacement for Pure Aortic Regurgitation: A Updated Systematic Review and Meta-Analysis

INTRODUCTION: Although the current treatment of choice of severe pure aortic regurgitation (AR) is surgical aortic valve replacement, increasing evidence has shown the potential of transcatheter aortic valve replacement (TAVR) in the management of patients who have high surgical risk profiles. AIMS: To conduct a systematic review and meta-analysis in evaluating the outcome of TAVR for pure AR based on current emerging evidence. Methods: Articles on MEDLINE, CINAHL, Web of Science, Embase, and Cochrane that studied the outcome of TAVR for the management of pure native AR were extracted. Device success rates, post-procedure moderate to severe AR rates as well as in-hospital, 30-day, and 1-year all-cause mortality rates were pooled for meta-analysis. Subgroup analyses of the above outcome comparing early-generation devices (EGD) and new-generation devices (NGD) were performed. Data were presented with incidences and 95% confidence intervals (CI), and I 2 was used to analyze heterogeneity. Results: Twenty-four studies involving 4435 patients were included. The pooled device success rate was 89.6% (95% CI 81.7% to 92.2%, I 2 = 91.63%), and 88.2% (95% CI 83.4% to 92.9%, I 2 =86.0%) of device placement was achieved by single implantation. Compare to EGD (72.2%, 95% CI 58.3% to 86.1%, I 2 =94.1%), NGD (91.6%, 95% CI 87.4% to 95.8%, I 2 =83.8%) has a higher device success rate. The overall in-hospital, 30-day, and 1-year all-cause mortality of TAVR for AR was 3.7% (95% CI 2.1% to 5.2%, I 2 =70.2%), 6.9% (95% CI 4.8% to 9.0%, I 2 =79.5%), and 13.9% (95% CI 8.5% to 19.2%, I 2 =89.1%), respectively. A higher 30-day all-cause mortality rate was observed in patients who received EGD implantations (12.6%, 95% CI 7.7% to 17.5%, I 2 =61.4%) than those have NGD placements (6.3%, 95% CI 3.9% to 8.7%, I 2 =51.0%). About 6.9% (95% CI 4.6% to 9.3%, I 2 =72.4%) and 4.6% (95% CI 1.5% to 7.7%, I 2 =86.2%) of patients continue to have moderate to severe AR post-procedure and at 30 days, respectively. CONCLUSION: Our current systematic review and meta-analysis suggests that TAVR may be a feasible option for patients with pure AR who have high surgical risks. NGD is superior to EGD in AR management due to its higher device success rate and favorable mortality outcome.

Impact of left ventricular end-diastolic pressure as a marker for diastolic dysfunction on long-term outcomes in patients undergoing transcatheter aortic valve replacement

ObjectiveThe aim of this study was to investigate the proportion of elevated left ventricular end-diastolic pressure (LVEDP) as an indicator of diastolic function after transcatheter aortic valve replacement (TAVR) and its implication in predicting long-term mortality. MethodsWe analyzed retrospectively collected data on 3328 patients with severe aortic stenosis undergoing TAVR in our institution between July 2009 and June 2021. Patients were stratified into two groups based on invasive post-procedural LVEDP measurements: normal (<15 mmHg) vs. elevated (≥15 mmHg) LVEDP. ResultsMean age of the patients was 81.6 years, and 53.3% were female. Elevated post-procedural LVEDP was identified in 2408 (72.3%) patients. The 5-year mortality rates were higher in the group with elevated LVEDP compared with the group with normal LVEDP (27.4% vs. 8.3%, p = 0.01; hazard ratio [HR] 1.22, 95% CI 1.05-1.41). A multivariate model revealed the following independent predictors of mortality after TAVR: post-procedural elevated LVEDP (HR 1.24, 95% CI 1.01-1.53), pre-procedural significant tricuspid regurgitation (HR 1.24, 95% CI 1.02-1.52) and pulmonary hypertension (PH) (HR 1.53, 95% CI 1.26-1.86). In the present study, a significant paravalvular leak after TAVR was not associated with higher mortality (HR 1.45, 95% CI-0.95-2.19, p = 0.75). ConclusionElevated post-procedural LVEDP in patients who undergo TAVR is an independent predictor of all-cause mortality. Furthermore, PH and tricuspid regurgitation were also identified as predictors of mortality. These data confirm that diastolic dysfunction is an important predictor of mortality in TAVR and should be considered to guide procedure timing, favoring an early interventional approach and management in aortic stenosis patients.

The effect of socioeconomic factors on patient outcomes in cardiac surgery.

Healthcare delivery is heterogenous; the reasons for this are numerous and complex. Patient-specific factors including geography, income, insurance status, age, and gender have been shown to bias surgical outcomes. Utilizing a prospectively collected all-payer database, we aim to evaluate the influence of socioeconomic factors on mortality and length of stay (LOS) after common cardiac surgical procedures. We utilized the National Inpatient Sample,Healthcare Cost and Utilization Project, Agency for Healthcare Research and Quality for the year 2019. We included patients undergoing coronary artery bypass grafting (CABG), aortic valve replacement (AVR), transcatheter aortic valve replacement (TAVR), and combined AVR/CABG using the 10th revision of the International Classification of Diseasesprocedure codes. AVR and CABG were combined into a separate cohort as this was felt to represent a different pathology than isolated valvular or coronary arterial disease. Baseline demographics were summarized. Multivariable regression was performed within each procedure group to model the odds of in-hospital mortality and hospital LOS with age, sex, insurance, zip-code median household income, and location as predictors. Baseline patient characteristics including gender, income, geography, and payer status were similar between CABG, AVR, and AVR/CABG. TAVR patients had a higher proportion of female sex and Medicare as the primary payer, with an overall greater age. Multivariable Cox proportional hazards regression found that higher income was strongly associated with decreased LOS following AVR and CABG, and moderately associated in TAVR and AVR/CABG. Private insurance was associated with a decreased LOS in patients undergoing CABG, AVR, TAVR, and AVR/CABG. Female sex and increased age were associated with increased odds of mortality in TAVR, CABG, and AVR/CABG. Private insurance was associated with a decreased odds of mortality in patients undergoing AVR. These findings reveal significant disparities in patient outcomes after routine cardiac operations that are associated with socioeconomic status. Patients who did not have private insurance or had lower incomes were found to be at risk for increased LOS. Women were at a higher risk of mortality for several operations, a finding which has been previously described elsewhere. Private insurance conveyed a decreased odds of mortality in patients undergoing AVR. This data set serves to highlight differences in healthcare outcomes based on a variety of socioeconomic, geographic, and other inherent factors. Additional research is needed to identify the mechanisms behind these disparities with the goal of providing equitable care to all patients.

Abstract 14021: A Meta Analysis for Clinical Outcomes of Transcatheter Aortic Valve Replacement in Patients With Bicuspid versus Tricuspid Aortic Valves Using Balloon Expandable versus Self Expanding Valves

Introduction: Over the past decade, several next generation transcatheter aortic valve replacement (TAVR) devices have been developed with the aim of improving patients’ outcomes. Bicuspid aortic valves (BAVs) are an emerging issue in TAVR practice. The goal of this study was to compare clinical outcomes of TAVR using balloon-expandable (BE) versus self-expanding (SE) transcatheter heart valves in patients with BAV vs tricuspid aortic valve (TAV). Methods: We searched PubMed, Cochrane and Embase databases systematically for relevant studies from inception to March 2022. The primary focus was 1-year all-cause mortality. Additional outcomes included short term (30-days) all-cause mortality, cardiovascular mortality, stroke, major/life threatening bleeding, permanent pacemaker (PPM) implantation and major vascular complications. Results: There were 28 studies with a total 346,033 patients who underwent TAVR, 17,835 of which had BAV stenosis. In the BE group, there was a statistically lower risk of mortality of TAVR in the BAV when compared to the TAV (OR 0.69 [95% CI 0.49-0.97]; p=0.03). In terms of short-term outcomes of BE group, the risks of all-cause mortality, stroke, PPM implantation, major bleeding, and major vascular complications were all similar between the two arms. In the SE group, there were not statistically significant in the clinical outcomes between patients in BAV and TAV. Conclusions: The use of balloon-expandable valves in TAVR was associated with a lower risk of 1-year mortality in patients with BAV compared to patients with TAV. These data support the need for a randomized trial to compare the balloon-expandable valves in BAV patients.

Trends in invasive treatment of patients hospitalized with aortic stenosis complicated by cardiogenic shock.

Before the development of transcatheter aortic valve replacement (TAVR), balloon aortic valvuloplasty (BAV) was the only potential nonsurgical intervention for patients with aortic stenosis complicated by cardiogenic shock. Emergent TAVR is now an option and has shown acceptable outcomes compared with elective TAVR. We explored how treatment patterns for aortic stenosis and cardiogenic shock among patients received invasive intervention have shifted since TAVR was introduced. We used the Nationwide In patients Sample to identify nonelective hospitalizations for patient with aortic stenosis complicated by cardiogenic shock who received invasive treatment (TAVR, BAV, or surgical aortic valve replacement [SAVR]). We explored the proportion treated with each treatment modality over time, the patient characteristics and in-hospital mortality associated with each treatment, and used multivariable logistic regression to examine whether changes in in-hospital mortality over time differed by treatment. Between 2010 and 2019, we identified 9899 hospitalizations for decompensated aortic stenosis with cardiogenic shock during which patients received invasive treatment (TAVR 17.7%, BAV 20.2%, SAVR 62.1%). Use of both TAVR and BAV has increased over time compared with SAVR (TAVR 6.6% ≥ 33.8%, BAV 8.4% ≥ 23.2%, SAVR 91.6% ≥ 43.0%; p < 0.001 for trend). The overall in-hospital mortality rate was 21.0%, which decreased over time for all treatments (TAVR 20.0% ≥ 18.8%, BAV 66.0% ≥ 25.5%, SAVR 17.7% ≥ 11.8%; linear trend p < 0.001 for each), with lower mortality for TAVR versus BAV at all time points. Patients treated with TAVR (vs. BAV) were less likely to require mechanical ventilation (36.8% vs. 46.3%, p < 0.001) or mechanical circulatory support (22.5% vs. 29.9%, p < 0.001). In the multivariable analysis, the interaction between treatment and time was not significant (p = 0.245), indicating the reduction in in-hospital mortality over time did not differ among the treatments. Since the introduction of TAVR, there has been a shift toward increased use of nonsurgical invasive treatments (both BAV and TAVR) for aortic stenosis and cardiogenic shock. Although in-hospital mortality has declined, it remains high in all groups, but particularly among patients treated with BAV, where the severity of cardiogenic shock appears to be higher than in those treated with other modalities.

Influence of center surgical aortic valve volume on outcomes of transcatheter aortic valve replacement

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.

Management of Se Management of Severe Aortic Stenosis in Car tic Stenosis in Cardiogenic Shock: diogenic Shock: Early P Early Percutaneous Mechanical Cir cutaneous Mechanical Circulatory Suppor y Support or Emer t or Emergent Transcatheter A anscatheter Aortic Valve Replacement? e Replacement?

Aortic stenosis (AS) affects an estimated 1.5 million patients in the United States, with 250,000 patients or more suffering severe, symptomatic aortic stenosis. A subset of these patients also have unrevascularized coronary artery disease and left ventricular dysfunction, representing an extreme risk population of AS patients. Cardiogenic shock (CS) complicates a small minority of AS presentations and/or patients referred for transcatheter aortic valve replacement (TAVR) but is responsible in these cases for a disproportionately high rate of morbidity and mortality. Indeed, CS results in a 4-fold increase in TAVR mortality, proportional to shock severity and largely independent of procedural complications. All patients undergoing TAVR should undergo an assessment of hemodynamics and vascular access as well as an estimation of risk for conduction system abnormalities, coronary occlusion, landing zone rupture, and stroke. In patients with pre-procedural CS or at a high risk of hemodynamic deterioration, preemptive or carefully planned, provisional use of mechanical circulatory support (MCS) helps ensure the best possible outcomes during TAVR.

Comparing outcomes of transcatheter versus surgical aortic valve replacement in patients with atrial arrythmias

Abstract Introduction In patients with severe aortic valve stenosis, clinical trials have demonstrated a similar mortality risk with transcatheter aortic valve replacement (TAVR) compared to surgical aortic valve replacement (SAVR) in low to intermediate-risk patients. However, data comparing these procedures in patients with atrial arrhythmias is lacking. Purpose This study aimed to evaluate and compare the in-hospital mortality and outcomes of TAVR and SAVR for severe aortic stenosis in patients with atrial fibrillation or atrial flutter. Methods We performed a retrospective cross-sectional analysis using the 2018 National Inpatient Sample. Patients aged 50 years and older with TAVR or SAVR related hospitalizations were identified. Patients with endocarditis and those undergoing coronary artery bypass grafting or other valvular procedures were excluded. Propensity score matching was utilized to mitigate selection bias. The scoring was based on a multivariate logistic regression model accounting for age, gender, race, hospital type, hospital region, hospital teaching status, median household income, and medical comorbidities. Using 8-to-1-digit match, we paired each admission in TAVR group with one admission in SAVR group. Results In 2018, a total of 3487 TAVRs and 1466 SAVRs were performed in patients who had atrial fibrillation or atrial flutter. TAVR and SAVR had no statistically significant difference in inpatient mortality (0.9% vs 0.8%, p=0.79). However, SAVR was associated with higher odds of cardiogenic shock (OR 1.82; 95% CI 1.41–2.35, p&amp;lt;0.0001), acute kidney injury (OR 2.29; 95% CI 1.77–2.97, p&amp;lt;0.0001), mechanical ventilation (OR 2.06; 95% CI 1.75–2.43, p&amp;lt;0.0001), pneumonia (OR 1.76; 95% CI 1.37–2.28, p&amp;lt;0.0001), pneumothorax (OR 6.38; 95% CI 4.17–9.76, p&amp;lt;0.0001) and postoperative hemorrhage (OR 3.21; 95% CI 2.13–4.85, p&amp;lt;0.0001). On the contrary, SAVR was associated with decreased likelihood of subsequent cardiac conduction disorders (OR 0.63; 95% CI 0.51–0.79, p&amp;lt;0.0001) and pacemaker implantation (OR 0.69; 95% CI 0.49–0.98, p=0.037). SAVR was associated with an increased length of hospitalization (3.9 vs. 8.4 days, p&amp;lt;0.0001), with no difference in medical costs. Conclusion Inpatient mortality for TAVR and SAVR was similar in patients with atrial fibrillation and atrial flutter. TAVR was associated with a lower risk of inpatient complications, indicating greater suitability for high-risk patients. However, clinicians should be cognizant of the increased risk for cardiac conduction disorders after TAVR, necessitating pacemaker implantation. Funding Acknowledgement Type of funding sources: None. Characteristics of the matched cohortForest plot comparing outcomes

Predicting and measuring mortality risk after transcatheter aortic valve replacement

ABSTRACT Introduction: Over the last decade, transcatheter aortic valve replacement (TAVR) has emerged as a treatment option for most patients with severe symptomatic aortic stenosis (AS). With growing indications and exponential increase in the number of TAVR procedures, it is important to be able to accurately predict mortality after TAVR. Areas covered: Herein, we review the surgical and TAVR-specific mortality prediction models (MPMs) and their performance in their original derivation and external validation cohorts. We then discuss the role of other important risk assessment tools such as frailty, echocardiographic parameters, and biomarkers in patients, being considered for TAVR. Expert opinion: Conventional surgical MPMs have suboptimal predictive performance and are mis-calibrated when applied to TAVR populations. Although a number of TAVR-specific MPMs have been developed, their utility is also limited by their modest discriminative ability when applied to populations external to their original derivation cohorts. There is an unmet need for robust TAVR MPMs that accurately predict post TAVR mortality. In the interim, heart teams should utilize the currently available TAVR-specific MPMs in conjunction with other prognostic factors, such as frailty, echocardiographic or computed tomography (CT) imaging parameters, and biomarkers for risk assessment of patients, being considered for TAVR.

Predictors of In-Hospital Mortality in Patients With End-Stage Renal Disease Undergoing Transcatheter Aortic Valve Replacement: A Nationwide Inpatient Sample Database Analysis

BackgroundPatients with end-stage renal disease (ESRD) were excluded from all major trials on the safety of transcatheter aortic valve replacement (TAVR). This study aims to identify the predictors of mortality due to the rising rate of TAVR utilization and subsequent mortality in patients with ESRD. MethodsThe National Inpatient Sample (NIS) (2002–2017) was queried to identify all patients with ESRD undergoing TAVR. The trend of all-cause mortality and its predictors were determined using a binary logistic regression model to obtain adjusted odds ratios (aOR). ResultsA total of 6836 patients (6341 survived, 495 died) were included in the analysis. The proportion of demographic and baseline comorbidities for survived vs. non-survived was nearly identical between the two groups. A rising trend in the utilization and mortality of TAVR in ESRD was noted. The adjusted odds of mortality was significantly higher for hypertension (6.92, 95% CI 3.78–12.66, p ≤ 0.0001), liver disease (4.51, 955 CI 3.30–6.17, p ≤ 0.0001), drug abuse (aOR 34.88, 95% CI 12.79–95.13, p ≤ 0.0001), periprocedural pneumonia (aOR 2.80, 95% CI 1.98–3.96, p ≤ 0.0001), cardiogenic shock (aOR, 5.97, 95% CI 4.63–7.70, p ≤ 0.0001), ST-elevation myocardial infarction (aOR 5.13, 95% CI 2.29–11.49, p ≤ 0.0001) and third-degree heart block (aOR 1.47, 955 CI 1.10–1.97, p0.01) in patients with ESRD undergoing TAVR. The mean length of stay and mean number of diagnoses recorded were also significantly higher for non-surviving TAVR patients. ConclusionBaseline hypertension, liver disease, third-degree heart block, periprocedural pneumonia, cardiogenic shock and STEMI can significantly increase the in-hospital mortality rate in ESRD patients undergoing TAVR.

Percutaneous large-bore axillary access is a safe alternative to surgical approach: A systematic review.

To systematically review relevant literature regarding cardiovascular outcomes of large-bore axillary arterial access via percutaneous and surgical approaches. In patients with severe peripheral arterial disease (PAD) undergoing cardiac interventions, large-bore femoral access may be prohibitive. The axillary artery provides an alternative vascular access for transcatheter aortic valve replacement (TAVR) or mechanical circulatory support. There have been limited comparisons of percutaneous transaxillary (pTAX) approach with the more traditional surgical transaxillary (sTAX) approach. Pubmed and Medline databases were queried through January 2019 for studies describing pTAX or sTAX approaches with TAVR or Impella insertion. Primary outcomes were access-related mortality, 30-day mortality, stroke, major vascular complications, and major bleeding. One hundred and fifty five studies were reviewed, with additional unpublished data from 1 institution. Twenty-two studies met the inclusion criteria. Patient data was heterogeneous, with 69% TAVR and 31% Impella use in the pTAX group, and 96% TAVR and 4% Impella use in the sTAX group. There was more cardiogenic shock in the pTAX group. When compared to surgical approach, the percutaneous approach had similar 30-day mortality for TAVR (5.6% vs 4.6%, OR non-significant) and Impella (43.4% vs 38.6%, OR non-significant), similar stroke rates (4.3% vs 4.2%, OR non-significant), similar major vascular complications (2.8% vs 2.3%, OR non-significant) and less major bleeding (2.7% vs 17.9%, OR significant). Data suggests large-bore pTAX access has similar 30-day mortality, stroke rates, and major vascular complications as sTAX access, with less major bleeding. Additional studies are needed to validate results.

Relationship Between Hospital Surgical Aortic Valve Replacement Volume and Transcatheter Aortic Valve Replacement Outcomes

ObjectivesThe aim of this study was to examine whether hospital surgical aortic valve replacement (SAVR) volume was associated with corresponding transcatheter aortic valve replacement (TAVR) outcomes. BackgroundRecent studies have demonstrated a volume-outcome relationship for TAVR. MethodsIn total, 208,400 fee-for-service Medicare beneficiaries were analyzed for all aortic valve replacement procedures from 2012 to 2015. Claims for patients <65 years of age, concomitant coronary artery bypass grafting surgery, other heart valve procedures, or other major open heart procedures were excluded, as were secondary admissions for aortic valve replacement. Hospital SAVR volumes were stratified on the basis of mean annual SAVR procedures during the study period. The primary outcomes were 30-day and 1-year post-operative TAVR survival. Adjusted survival following TAVR was assessed using multivariate Cox regression. ResultsA total of 65,757 SAVR and 42,967 TAVR admissions were evaluated. Among TAVR procedures, 21.7% (n = 9,324) were performed at hospitals with <100 (group 1), 35.6% (n = 15,298) at centers with 100 to 199 (group 2), 22.9% (n = 9,828) at centers with 200 to 299 (group 3), and 19.8% (n = 8,517) at hospitals with ≥300 SAVR cases/year (group 4). Compared with group 4, 30-day TAVR mortality risk-adjusted odds ratios were 1.32 (95% confidence interval: 1.18 to 1.47) for group 1, 1.25 (95% confidence interval: 1.12 to 1.39) for group 2, and 1.08 (95% confidence interval: 0.82 to 1.25) for group 3. These adjusted survival differences in TAVR outcomes persisted at 1 year post-procedure. ConclusionsTotal hospital SAVR volume appears to be correlated with TAVR outcomes, with higher 30-day and 1-year mortality observed at low-volume centers. These data support the importance of a viable surgical program within the heart team, and the use of minimum SAVR hospital thresholds may be considered as an additional metric for TAVR performance.

Temporal Trends and Outcomes of Transcatheter Versus Surgical Aortic Valve Replacement for Bicuspid Aortic Valve Stenosis

ObjectivesThe purpose of this study was to assess the temporal trends of transcatheter aortic valve replacement (TAVR) in patients with bicuspid aortic stenosis (AS), and to compare the outcomes between TAVR and surgical aortic valve replacement (SAVR) in this population. BackgroundRandomized trials comparing TAVR to SAVR in AS with bicuspid valve are lacking. MethodsThe study queried the National Inpatient Sample database (years 2012 to 2016) to identify hospitalizations for bicuspid AS who underwent isolated aortic valve replacement. A propensity-matched analysis was used to compare outcomes of hospitalizations for TAVR versus SAVR for bicuspid AS and TAVR for bicuspid AS versus tricuspid AS. ResultsThe analysis included 31,895 hospitalizations with bicuspid AS, of whom 1,055 (3.3%) underwent TAVR. TAVR was increasingly utilized during the study period for bicuspid AS (ptrend = 0.002). After matching, TAVR and SAVR had similar in-hospital mortality (3.1% vs. 3.1%; odds ratio: 1.00; 95% confidence interval: 0.60 to 1.67). There was no difference between TAVR and SAVR in the rates of cardiac arrest, cardiogenic shock, acute kidney injury, hemopericardium, cardiac tamponade, or acute stroke. TAVR was associated with lower rates of acute myocardial infarction, post-operative bleeding, vascular complications, and discharge to nursing facility as well as a shorter length of hospital stay. On the contrary, TAVR was associated with a higher incidence of complete heart block and permanent pacemaker insertion. TAVR for bicuspid AS was associated with similar in-hospital mortality compared with tricuspid AS. ConclusionsThis nationwide analysis showed similar in-hospital mortality for TAVR and SAVR in patients with bicuspid AS. TAVR for bicuspid AS was also associated with similar in-hospital mortality compared with tricuspid AS. Further studies are needed to evaluate long-term outcomes of TAVR for bicuspid AS.

Machine Learning Prediction Models for In-Hospital Mortality After Transcatheter Aortic Valve Replacement

ObjectivesThis study sought to develop and compare an array of machine learning methods to predict in-hospital mortality after transcatheter aortic valve replacement (TAVR) in the United States. BackgroundExisting risk prediction tools for in-hospital complications in patients undergoing TAVR have been designed using statistical modeling approaches and have certain limitations. MethodsPatient data were obtained from the National Inpatient Sample database from 2012 to 2015. The data were randomly divided into a development cohort (n = 7,615) and a validation cohort (n = 3,268). Logistic regression, artificial neural network, naive Bayes, and random forest machine learning algorithms were applied to obtain in-hospital mortality prediction models. ResultsA total of 10,883 TAVRs were analyzed in our study. The overall in-hospital mortality was 3.6%. Overall, prediction models’ performance measured by area under the curve were good (>0.80). The best model was obtained by logistic regression (area under the curve: 0.92; 95% confidence interval: 0.89 to 0.95). Most obtained models plateaued after introducing 10 variables. Acute kidney injury was the main predictor of in-hospital mortality ranked with the highest mean importance in all the models. The National Inpatient Sample TAVR score showed the best discrimination among available TAVR prediction scores. ConclusionsMachine learning methods can generate robust models to predict in-hospital mortality for TAVR. The National Inpatient Sample TAVR score should be considered for prognosis and shared decision making in TAVR patients.

Association of Hospital Surgical Aortic Valve Replacement Quality With 30-Day and 1-Year Mortality After Transcatheter Aortic Valve Replacement

Hospital 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. We 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. This 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. Isolated aortic valve replacements. Hospital 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. A 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). Hospitals 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.

Abstract 17027: Racial Disparities in Transcatheter Aortic Valve Replacement Access: Geographic Analysis Suggesting Disparate Access to Care

Background: Transcatheter aortic valve replacement (TAVR) has ample randomized trial evidence that it can reduce mortality and cost for patients with aortic stenosis. Yet racial disparities in procedure access are poorly understood. Methods: This case-control prospectively enrolled TAVR subjects at a single high-volume quaternary academic medical center in Houston, Texas, USA, from 11/8/11-3/28/18. Neural network machine learning-supported binomial probability testing was conducted comparing the Houston population versus the center’s TAVR rates by race, with mortality and cost extrapolations. The IOM definition of health inequities was applied using the rank and replace method for counterfactual comparison (matching subjects by insurance and Society of Thoracic Surgery [STS] risk score for TAVR eligibility). Results: Compared to the Houston population, TAVR subjects (N=1641) were significantly more likely to be Caucasians (51.93% vs 77.26%), and less likely to be African Americans (14.80% vs 6.02%), Hispanics (23.63% vs 15.02%), or other races (9.50% vs 1.70%), all p&lt;0.001. Among TAVR subjects with private insurance, the large majority were Caucasian (832, 85.60%), with the minority being African American (34, 3.50%), Hispanic (96, 9.88%), and other (10, 37.04%) (private insurance by Caucasian versus non-Caucasian, p&lt;0.001). Based on TAVR mortality and cost savings in the PARNTER trial, access disparities for racial minorities over 5 years may result in 858 excess deaths, $130,000 per patient excess costs, and $111.5 million excess costs per the overall sample of eligible presenting Houston subjects. The predicted versus actual racial distribution of TAVR for each minority group matched to Caucasians by insurance and STS score was significantly greater than the actual (each group comparison to Caucasians, p&lt;0.001). Conclusion: Multi-year data from our high-volume center suggest Houston racial minorities are less likely to undergo TAVR, potentially translating into a growing number of preventable excess early deaths and costs as disease incidence increases. Additional studies are underway to determine and reduce the degree of preventable race-related disparities independent of known access predictors.

Impact of transcatheter aortic valve implantation on surgical aortic valve

Introduction and objectivesTAVR is thought to change the volumes, characteristics, and outcomes of patients with aortic stenosis undergoing SAVR. We sought to investigate the impact of increasing transcatheter aortic valve replacement (TAVR) volumes on surgical aortic valve replacement (SAVR) volumes and to assess the evolution in baseline demographics and its impact on 30-day clinical outcomes across TAVR and SAVR patients. MethodsFrom June 2007 through September 2015, 3543 consecutive patients with severe aortic stenosis who underwent TAVR (n=1407) or SAVR (n=2136) in a single center were subcategorized into nine cohorts defined by procedure year. These cohorts were examined for differences in volumes, baseline demographics, and 30-day mortality. ResultsWe observed a reduction in SAVR compared to TAVR volumes over time: from 79% in 2007 to 48% in 2015 (P<0.001). The mean STS score of the TAVR patients decreased significantly from 6.8 in 2007 to 4.3 in 2015 (P<0.001). Concurrently, the crude 30-day mortality for TAVR improved from 11% in 2007 to 3% in 2015 (P<0.001). The overall 30-day mortality was similar between TAVR and SAVR after adjusting for the independent predictors of mortality (adjusted odds ratio (OR)=0.758; P=0.2). ConclusionsIn a high-volume surgical center, we observed a significant decrease in patients undergoing SAVR compared to TAVR. We show an important shift toward the selection of lower surgical risk patients for TAVR. Overall 30-day mortality was similar between TAVR and SAVR after adjusting for baseline characteristics.

STS RISK SCORE AS PREDICTOR OF 30-DAY MORTALITY IN TRANSCATHETER VERSUS SURGICAL AORTIC VALVE REPLACEMENT

The Society of Thoracic Surgery (STS) risk model was designed to predict operative morbidity and mortality after adult cardiac surgery. The STS score now plays an important role in transcatheter aortic valve replacement (TAVR). The STS score's validity for predicting TAVR mortality, however, has not

Impact of Transcatheter Aortic Valve Replacement on Surgical Volumes and Outcomes in a Tertiary Academic Cardiac Surgical Practice

Transcatheter aortic valve replacement (TAVR) was FDA approved for the Sapien valve (Edwards Lifesciences) in the United States in November 2011. We sought to examine the impact of TAVR post-FDA approval on aortic valve surgery at our institution. Prospective data were collected on 573 consecutive patients that underwent surgical aortic valve replacement (SAVR) or TAVR with either the Sapien or Sapien XT from January 1, 2009 through December 31,2014. Patients were divided into the following groups: SAVR before TAVR (n= 215), SAVR post TAVR (n= 163), and TAVR (n= 195). The 30-day mortality was not different among the 3 groups, but the mortality for the SAVR post TAVR group was better than the SAVR before TAVR group (p= 0.03). Postoperative hospital length of stay, ventilation hours, and atrial fibrillation were all decreased in the TAVR group. The number of isolated SAVRs increased after TAVR from 60 per year in group 1 to 67 per year in group 2. The total number of all isolated aortic valve procedures (SAVR+ TAVR) increased from 60 per year to 177 per year. The TAVR group was divided into the following subgroups to examine the procedural learning curve: patients 1 to 50, patients 51 to 100, and patients 101 to 195. Mortality was higher in group 1 (8%) vs group 2 (0%) and group 3 (1%). Since initiation of the TAVR program at our institution, the total number of aortic valve procedures has increased. Transcatheter aortic valve replacement patients had more preoperative comorbidities, but no difference in postoperative morbidity or mortality and shorter length of stay. Transcatheter aortic valve replacement mortality has continued to improve since the inception of the program.