Sex-Based Differences in Outcomes With Percutaneous Transcatheter Repair of Mitral Regurgitation With the MitraClip System: Transcatheter Valve Therapy Registry From 2011 to 2017.

BACKGROUND: Women have a higher rate of adverse events after mitral valve surgery. We sought to evaluate whether outcomes after transcatheter edge-to-edge repair intervention by sex have similar trends to mitral valve surgery. METHODS: The primary outcome was 1-year major adverse events defined as a composite of all-cause mortality, stroke, and any bleeding in the overall study cohort. Patients who underwent transcatheter edge-to-edge repair for mitral regurgitation with the MitraClip system in the Society of Thoracic Surgery/American College of Cardiology Transcatheter Valve Therapy registry were evaluated. Linked administrative claims from the Centers for Medicare and Medicaid Services were used to evaluate 1-year clinical outcomes. Associations between sex and outcomes were evaluated using a multivariable logistic regression model for in-hospital outcomes and Cox model for 1-year outcomes. RESULTS: From November 2013 to March 2017, 5295 patients, 47.6% (n=2523) of whom were female, underwent transcatheter edge-to-edge repair. Females were less likely to have >1 clip implanted (P<0.001) and had a lower adjusted odds ratio of device success (adjusted odds ratio, 0.78 [95% CI, 0.67-0.90]), driven by lower odds of residual mitral gradient <5 mm Hg (adjusted odds ratio, 0.54 [CI, 0.46-0.63]) when compared with males. At 1-year follow-up, the primary outcome did not differ by sex. Female sex was associated with lower adjusted 1-year risk of all-cause mortality (adjusted hazard ratio, 0.80 [CI, 0.68-0.94]), but the adjusted 1-year risk of stroke and any bleeding did not differ by sex. CONCLUSIONS: No difference in composite outcome of all-cause mortality, stroke, and any bleeding was observed between females and males. Adjusted 1-year all-cause mortality was lower in females compared with males.

Racial, ethnic and socioeconomic disparities in patients undergoing transcatheter mitral edge-to-edge repair.

BACKGROUND: Transcatheter mitral edge-to-edge repair (TEER) is an increasingly common procedure performed on patients with severe mitral regurgitation. This study assessed the impact of race/ethnicity and socioeconomic status on in-hospital complications after TEER. METHODS: Cohort-based observational study using the National Inpatient Sample between October 2013 and December 2018. The population was stratified into 4 groups based on race/ethnicity and quartiles of neighborhood income levels. The primary outcome was in-hospital complications, defined as the composite of death, bleeding, cardiac and vascular complications, acute kidney injury, and ischemic stroke. RESULTS: 3795 hospitalizations for TEER were identified. Patients of Black and Hispanic race/ethnicity comprised 7.4% and 6.4%, respectively. We estimated that White patients received TEER with a frequency of 38.0/100,000, compared to 29.7/100,000 for Blacks and 30.5/100,000 for Hispanics. In-hospital complications occurred in 20.2% of patients and no differences were found between racial/ethnic groups (P = 0.06). After multilevel modelling, Black and Hispanic patients had similar rate of overall in-hospital complications (OR: 0.84, CI:0.67-1.05 and OR: 0.84, CI:0.66-1.07, respectively) as compared to White patients, however, higher rates of death were observed in Black patients. Individuals living in income quartile-1 had worse in-hospital outcomes as compared to quartile-4 (OR: 1.19, CI:0.99-1.42). CONCLUSION: In this study assessing racial/ethnic disparities in TEER outcomes, aged-adjusted race/ethnicity minorities were less underrepresented as compared to other structural heart interventions. Black patients experienced a higher rate of in-hospital death, but similar overall rate of post-procedural adverse events as compared to White patients. Lower income levels appear to negatively impact on in-hospital outcomes. BRIEF SUMMARY: This study appraises race/ethnic and socioeconomical disparities in access and outcomes following transcatheter mitral edge-to-edge repair. Racial minority groups were less underrepresented as compared to other structural heart interventions. While Black patients experienced a higher rate of in-hospital death, they experienced similar overall rate of post-procedural complications compared to White patients. Lower income levels also appeared to negatively impact on outcomes.

Racial, ethnic and socioeconomic disparities in patients undergoing left atrial appendage closure.

OBJECTIVE: This manuscript aims to explore the impact of race/ethnicity and socioeconomic status on in-hospital complication rates after left atrial appendage closure (LAAC). METHODS: The US National Inpatient Sample was used to identify hospitalisations for LAAC between 1 October 2015 to 31 December 2018. These patients were stratified by race/ethnicity and quartiles of median neighbourhood income. The primary outcome was the occurrence of in-hospital major adverse events, defined as a composite of postprocedural bleeding, cardiac and vascular complications, acute kidney injury and ischaemic stroke. RESULTS: Of 6478 unweighted hospitalisations for LAAC, 58% were male and patients of black, Hispanic and 'other' race/ethnicity each comprised approximately 5% of the cohort. Adjusted by the older Americans population, the estimated number of LAAC procedures was 69.2/100 000 for white individuals, as compared with 29.5/100 000 for blacks, 47.2/100 000 for Hispanics and 40.7/100 000 for individuals of 'other' race/ethnicity. Black patients were ~5 years younger but had a higher comorbidity burden. The primary outcome occurred in 5% of patients and differed significantly between racial/ethnic groups (p<0.001) but not across neighbourhood income quartiles (p=0.88). After multilevel modelling, the overall rate of in-hospital major adverse events was higher in black patients as compared with whites (OR: 1.60, 95% CI 1.22 to 2.10, p<0.001); however, the incidence of acute kidney injury was higher in Hispanics (OR: 2.19, 95% CI 1.52 to 3.17, p<0.001). No significant differences were found in adjusted overall in-hospital complication rates between income quartiles. CONCLUSION: In this study assessing racial/ethnic disparities in patients undergoing LAAC, minorities are under-represented, specifically patients of black race/ethnicity. Compared with whites, black patients had higher comorbidity burden and higher rates of in-hospital complications. Lower socioeconomic status was not associated with complication rates.

National Landscape of Hospitalizations in Patients with Left Ventricular Assist Device. Insights from the National Readmission Database 2010-2015.

The number of patients with left ventricular assist devices (LVAD) has increased over the years and it is important to identify the etiologies for hospital admission, as well as the costs, length of stay and in-hospital complications in this patient group. Using the National Readmission Database from 2010 to 2015, we identified patients with a history of LVAD placement using International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM) code V43.21. We aimed to identify the etiologies for hospital admission, patient characteristics, and in-hospital outcomes. We identified a total of 15,996 patients with an LVAD, the mean age was 58 years and 76% were males. The most common cause of hospital readmission after LVAD was heart failure (HF, 13%), followed by gastrointestinal (GI) bleed (11.8%), device complication (11.5%), and ventricular tachycardia/fibrillation (4.2%). The median length of stay was 6 days (3-11 days) and the median hospital costs was $12,723 USD. The in-hospital mortality was 3.9%, blood transfusion was required in 26.8% of patients, 20.5% had acute kidney injury, 2.8% required hemodialysis, and 6.2% of patients underwent heart transplantation. Interestingly, the most common cause of readmission was the same as the diagnosis for the preceding admission. One in every four LVAD patients experiences a readmission within 30 days of a prior admission, most commonly due to HF and GI bleeding. Interventions to reduce HF readmissions, such as speed optimization, may be one means of improving LVAD outcomes and resource utilization.

Regional Variation in Procedural and Clinical Outcomes Among Patients With ST Elevation Myocardial Infarction With Cardiogenic Shock.

There is limited data on regional differences in patient characteristics, practice patterns, and clinical outcomes in patients with ST elevation myocardial infarction (STEMI) with cardiogenic shock (CS) in the United States (US). We aimed to identify variations in treatment methods and clinical outcomes in patients with STEMI CS between the 4 US regions. Using the National Inpatient Sample database, we identified adult patients admitted with STEMI associated with CS between 2006 and 2015 using ICD-9-DM codes. Based on the US regions (Northeast, Midwest, South, and West), we divided patients in 4 cohorts and compared baseline patient characteristics, clinical outcomes and procedural outcomes. A total of 186,316 patients with STEMI CS were included; 32,303 (17.3%) were hospitalized in the Northeast, 43,634 (23.4%) in the Midwest, 70,036 (37.8%) in the South, and 40,043 (21.5%) in the West. Although nonstatistically significant, the in-hospital mortality was higher in Northeast region (37.7%), followed by the South (36.6%), West (35.7%), and Midwest (35.2%). Rates of percutaneous coronary intervention were higher in the Midwest (68.5%) and lower in the Northeast (56%). The use of percutaneous ventricular assist device and ECMO was higher in the Northeast (3.3% and 2.2%) and lower in the West (2.1% and 0.4%). The median length of stay was similar among all 4 cohorts (6 days) but median hospital costs were higher in the West ($36, 614) and lower in the South ($28,795). In conclusion, there are significant geographic variations in practice patterns, healthcare cost, and in-hospital outcomes in patients with STEMI complicated by CS between 4 US regions.

Trends and Outcomes of Intravascular Imaging-guided Percutaneous Coronary Intervention in the United States.

INTRODUCTION: Intravascular imaging-guided percutaneous coronary intervention (PCI) has shown to improve outcomes in randomized controlled trials. However, there are little real-world data about intravascular imaging utilization during PCI and its outcomes in the United States. METHODS: We conducted an observational analysis on the use of intravascular imaging (Intravascular Ultrasound or Optical Coherence Tomography)-guided PCI in 2,425,036 patients undergoing PCI between January 2010 and December 2014 from the Nationwide Inpatient Sample database. Utilizing propensity score matching, 83,988 matched pairs were identified. The primary outcome was in-hospital mortality. The secondary outcomes included cardiogenic shock and acute kidney injury. RESULTS: Among the 2,425,036 patients, 161,808 (6.7%) underwent imaging-guided PCI. Use of imaging-guidance increased from 6% in 2010 to 6.6% in 2014 (Ptrend < 0.001). The in-hospital mortality was significantly different between imaging-guided PCI and angiography-guided PCI [1.0% vs. 1.5%; adjusted OR: 0.67; 95% confidence interval (CI): 0.54-0.83, P < 0.001]. The rates of cardiogenic shock (2.5% vs. 3.1%; adjusted OR: 0.78; 95% CI: 0.66-0.93; P = 0.005) were significantly lower in imaging-guided PCI group and acute kidney injury rates (7.0% vs. 7.1%; adjusted OR: 0.99; 95% CI: 0.89-1.12; P = 0.919) were not significantly different. CONCLUSIONS: Imaging-guided PCI is associated with lower in-hospital mortality. Yet, a small proportion of patients undergoing PCI have imaging-guidance.

Racial/Ethnic Disparities in Patients Undergoing Transcatheter Aortic Valve Replacement: Insights from the Healthcare Cost and Utilization Project's National Inpatient Sample.

PURPOSE: To identify racial/ethnic disparities in utilization rates, in-hospital outcomes and health care resource use among Non-Hispanic Whites (NHW), African Americans (AA) and Hispanics undergoing transcatheter aortic valve replacement (TAVR) in the United States (US). METHODS AND RESULTS: The National Inpatient Sample database was queried for patients ≥18 years of age who underwent TAVR from 2012 to 2014. The primary outcome was all-cause in hospital mortality. A total of 36,270 individuals were included in the study. The number of TAVR performed per million population increased in all study groups over the three years [38.8 to 103.8 (NHW); 9.1 to 26.4 (AA) and 9.4 to 18.2 (Hispanics)]. The overall in-hospital mortality was 4.2% for the entire cohort. Race/ethnicity showed no association with in-hospital mortality (P > .05). Though no significant difference were found between AA and NHW in any secondary outcome, being Hispanic was associated with higher incidence of acute myocardial infarction (aOR = 2.02; 95% CI, 1.06-3.85; P = .03), stroke/transient ischemic attack (aOR = 1.81; 95% CI, 1.04-3.14; P = .04), acute kidney injury (aOR = 1.65; 95% CI, 1.23-2.21; P < .01), prolonged length of stay (aOR = 1.18; 95% CI, 1.08-1.29; P < .01) and higher hospital costs (aOR = 1.27; 95% CI, 1.18-1.36; P < .01). CONCLUSION: There are significant racial disparities in patients undergoing TAVR in the US. Though in-hospital mortality was not associated with race/ethnicity, Hispanic patients had less TAVR utilization, higher in-hospital complications, prolonged length of stay and increased hospital costs.

Predictors of Hospital Cost After Transcatheter Aortic Valve Implantation in the United States: From the Nationwide Inpatient Sample Database.

We aimed to identify risk factors of high hospitalization cost after transcatheter aortic valve implantation (TAVI). TAVI expenditure is generally higher compared with surgical aortic valve replacement. We queried the Nationwide Inpatient Sample database from January 2011 to September 2015 to identify those who underwent endovascular TAVI. Estimated cost of hospitalization was calculated by merging the Nationwide Inpatient Sample database with cost-to-charge ratios available from the Healthcare Cost and Utilization Project. Patients were divided into quartiles (lowest, medium, high, and highest) according to the hospitalization cost, and multivariable regression analysis was performed to identify patient characteristics and periprocedural complications associated with the highest cost group. A total of 9,601 TAVI hospitalizations were identified. Median in-hospital costs of the highest and lowest groups were $82,068 and $33,966, respectively. Patients in the highest cost group were older and more likely women compared with the lowest cost group. Complication rates (68.4% vs 22.5%) and length of stay (median 10 days vs 3 days) were both approximately 3 times higher and longer, respectively, in the highest cost group. Co-morbidities such as heart failure, peripheral vascular disease, atrial fibrillation, anemia, and chronic dialysis as well as almost all complications were associated with the highest cost group. The complications with the highest incremental cost were acute respiratory failure requiring intubation ($28,209), cardiogenic shock ($22,401), and acute kidney injury ($16,974). Higher co-morbidity burden and major complications post-TAVI were associated with higher hospitalization costs. Prevention of these complications may reduce TAVI-related costs.

Incidence, Predictors, and In-Hospital Outcomes of Transcatheter Aortic Valve Implantation After Nonelective Admission in Comparison With Elective Admission: From the Nationwide Inpatient Sample Database.

Candidates for transcatheter aortic valve implantation (TAVI) are generally older with multiple co-morbidities and are therefore susceptible to nonelective admissions before scheduled TAVI. Frequency, predictors, and outcomes of TAVI after nonelective admission are under-explored. We queried the Nationwide Inpatient Sample database, an administrative database, from January 2012 to September 2015 to identify hospitalization in those age ≥50 who had transarterial TAVI. A propensity-matched cohort was created to compare the outcomes between nonelective and elective admission who had TAVI. The primary outcome was in-hospital mortality. A total of 9,521 TAVI admissions were identified during the study period. Of these admissions, 22.3% were nonelective admissions. Pulmonary circulation disorders (adjusted odds ratio [aOR] 1.38), anemia (aOR 1.54), congestive heart failure (aOR 1.37), chronic kidney disease (aOR 1.28; all p <0.001), and atrial fibrillation (aOR 1.17, p = 0.006) were independent risk factors for nonelective admission. In a propensity-matched cohort (1,683 admissions in each cohort), in-hospital mortality was similar (4.0% vs 2.8%, p = 0.052). Nonelective admissions had higher rates of acute myocardial infarction (5.2% vs 0.7%), fatal arrhythmia (9.4% vs 6.0%), acute kidney injury (25.9% vs 17.1%), respiratory failure requiring intubation (0.26% vs 0.19%), cardiogenic shock (5.1% vs 2.1%; all p <0.001), and bleeding requiring transfusion (13.1% vs 10.1%, p = 0.006) during the index-hospitalization. Hospital length of stay (11.4 days vs 6.5 days, p <0.001) and hospital cost ($68,669 vs $57,442, p <0.001) were both increased in nonelective admissions. Nonelective admission accounted for approximately one-fifth of total TAVI with significantly different cohort profiles. Our results suggest that nonelective TAVI has higher adverse outcomes and increased health resource utilization. Expedition in TAVI process in high-risk cohorts may result in better outcomes.

Contemporary Sex-Based Differences by Age in Presenting Characteristics, Use of an Early Invasive Strategy, and Inhospital Mortality in Patients With Non-ST-Segment-Elevation Myocardial Infarction in the United States.

BACKGROUND: Prior studies have reported higher inhospital mortality in women versus men with non-ST-segment-elevation myocardial infarction. Whether this is because of worse baseline risk profile compared with men or sex-based disparities in treatment is not completely understood. METHODS AND RESULTS: We queried the 2003 to 2014 National Inpatient Sample databases to identify all hospitalizations in patients aged ≥18 years with the principal diagnosis of non-ST-segment-elevation myocardial infarction. Complex samples multivariable logistic regression models were used to examine sex differences in use of an early invasive strategy and inhospital mortality. Of 4 765 739 patients with non-ST-segment-elevation myocardial infarction, 2 026 285 (42.5%) were women. Women were on average 6 years older than men and had a higher comorbidity burden. Women were less likely to be treated with an early invasive strategy (29.4% versus 39.2%; adjusted odds ratio, 0.92; 95% confidence interval, 0.91-0.94). Women had higher crude inhospital mortality than men (4.7% versus 3.9%; unadjusted odds ratio, 1.22; 95% confidence interval, 1.20-1.25). After adjustment for age (adjusted odds ratio, 0.96; 95% confidence interval, 0.94-0.98) and additionally for comorbidities, other demographics, and hospital characteristics, women had 10% lower odds of inhospital mortality (adjusted odds ratio, 0.90; 95% confidence interval, 0.89-0.92). Further adjustment for differences in the use of an early invasive strategy did not change the association between female sex and lower risk-adjusted inhospital mortality. CONCLUSIONS: Although women were less likely to be treated with an early invasive strategy compared with men, the lower use of an early invasive strategy was not responsible for the higher crude inhospital mortality in women, which could be entirely explained by older age and higher comorbidity burden.

Regional Variation in Utilization, In-hospital Mortality, and Health-Care Resource Use of Transcatheter Aortic Valve Implantation in the United States.

We queried the National Inpatient Sample database from 2012 to 2014 to identify all patients aged ≥18 years undergoing transcatheter aortic valve implantation (TAVI) in the United States. Regional differences in TAVI utilization, in-hospital mortality, and health-care resource use were analyzed. Of 41,025 TAVI procedures in the United States between 2012 and 2014, 10,390 were performed in the Northeast, 9,090 in the Midwest, 14,095 in the South, and 7,450 in the West. Overall, the number of TAVI implants per million adults increased from 24.8 in 2012 to 63.2 in 2014. The utilization of TAVI increased during the study period in all 4 geographic regions, with the number of implants per million adults being highest in the Northeast, followed by the Midwest, South, and West, respectively. Overall in-hospital mortality was 4.2%. Compared with the Northeast, risk-adjusted in-hospital mortality was higher in the Midwest (adjusted odds ratio [aOR] 1.26 [1.07 to 1.48]) and the South (aOR 1.61 [1.40 to 1.85]) and similar in the West (aOR 1.00 [0.84 to 1.18]). Average length of stay was shorter in all other regions compared with the Northeast. Among patients surviving to discharge, disposition to a skilled nursing facility or home health care was most common in the Northeast, whereas home discharge was most common in the West. Average hospital costs were highest in the West. In conclusion, we observed significant regional differences in TAVI utilization, in-hospital mortality, and health-care resource use in the United States. The findings of our study may have important policy implications and should provide an impetus to understand the source of this regional variation.

Recognized Obstructive Sleep Apnea is Associated With Improved In-Hospital Outcomes After ST Elevation Myocardial Infarction.

BACKGROUND: Obstructive sleep apnea (OSA) is an independent risk factor for many cardiovascular conditions such as coronary artery disease, myocardial infarction, systemic hypertension, pulmonary hypertension, and stroke. However, the association of OSA with outcomes in patients hospitalized for ST-elevation myocardial infarction remains controversial. METHODS AND RESULTS: We used the nation-wide inpatient sample between 2003 and 2011 to identify patients with a primary discharge diagnosis of ST-elevation myocardial infarction and then used the International Classification of Diseases, Clinical Modification code 327.23 to identify a group of patients with OSA. The primary outcome of interest was in-hospital mortality, and secondary outcomes were in-hospital cardiac arrest, length of stay and hospital charges. Our cohort included 1 850 625 patients with ST-elevation myocardial infarction, of which 1.3% (24 623) had documented OSA. OSA patients were younger and more likely to be male, smokers, and have chronic pulmonary disease, depression, hypertension, known history of coronary artery disease, dyslipidemia, obesity, and renal failure (P<0.001 for all). Patients with OSA had significantly decreased in-hospital mortality (adjusted odds ratio, 0.78 [95% CI, 0.73-0.84]), longer hospital stay (5.00±4.68 versus 4.85±5.96 days), and incurred greater hospital charges ($79 460.12±70 621.91 versus $62 889.91±69 124.15). There was no difference in incidence of in-hospital cardiac arrest (adjusted odds ratio, 0.93 [95% CI, 0.84-1.03]) between these 2 groups. CONCLUSION: ST-elevation myocardial infarction patients with recognized OSA had significantly decreased mortality compared with patients without OSA. Although patients with OSA had longer hospital stays and incurred greater hospital charges, there was no difference in incidence of in-hospital cardiac arrest.

Left atrial appendage morphology assessment for risk stratification of embolic stroke in patients with atrial fibrillation: A meta-analysis.

BACKGROUND: Thromboembolic event (TE) risk stratification is performed by using CHA2DS2VASc score. It has been suggested that left atrial appendage (LAA) morphology independently influences TE risk in patients with nonvalvular atrial fibrillation. LAA morphology has been classified into 4 types: chicken wing, cauliflower, windsock, and cactus. OBJECTIVE: The purpose of this study was to determine TE risk for each LAA morphology in patients with atrial fibrillation with low to intermediate TE risk. METHODS: A systematic review of MEDLINE, Cochrane Library, and Embase for studies that used computed tomography, tridimensional transesophageal echocardiography, and cardiac magnetic resonance imaging to categorize the LAA morphologies with assessment of TE prevalence. Odds ratio (OR) and 95% confidence intervals (CIs) were measured using the Mantel-Haenszel method. The fixed effects model was used, and if heterogeneity (I2) was >25%, effects were analyzed using a random model. RESULTS: Eight studies with 2596 patients were included. Eighty-four percent (n=1872) of patients had a CHADS2 score of <2. TE risk was lower in chicken wing morphology than in non-chicken wing morphology (OR 0.46; 95% CI 0.36-0.58). Likewise, chicken wing morphology had lower TE risk than did other morphologies (chicken wing vs cauliflower: OR 0.38; 95% CI 0.26-0.56; chicken wing vs windsock: OR 0.48; 95% CI 0.31-0.73; chicken wing vs cactus: OR 0.49; 95% CI 0.36-0.66). CONCLUSION: Patients with chicken wing LAA morphology are less likely to develop TE than patients with non-chicken wing morphology. LAA morphology may be a valuable criterion in predicting TE and could affect the stratification and anticoagulation management of patients with low to intermediate TE risk.