Sex Disparities in the Management, Outcomes, and Transfer of Patients Hospitalized for Cardiogenic Shock.

Background: Previous studies have shown that women have worse outcomes for cardiogenic shock (CS) than men. Patients who receive care in CS "hubs" have also been shown to have improved outcomes when compared to those treated at "spokes." This study aimed to examine the presence of sex disparities in the outcomes of CS in relation to hospital type. Methods: Hospitalizations of adults with a diagnosis of CS were identified using data from the 2016-2019 Nationwide Readmissions Database. CS "hubs" were defined as any centers receiving at least 1 interhospital transfer with CS, while those without such transfers were classified as "spokes." Data were combined across years and multivariable logistic regression modeling was used to evaluate the association of sex with in-hospital mortality, invasive procedures, and transfer to hubs. Results: There were a total of 618,411 CS hospitalizations (62.2% men) with CS related to acute myocardial infarction comprising 15.3 to 17.3% of women hospitalizations and 17.8 to 20.3% of men hospitalizations. In-hospital mortality was lower at hubs (34.5% for direct admissions, 31.6% for transfers) than at spokes (40.3%, all P < .01). Women underwent fewer invasive procedures (right heart catheterization, percutaneous coronary intervention, mechanical circulatory support) and had higher mortality than men. Female sex was independently associated with decreased transfers to hubs (odds ratio, 0.93; 95% CI, 0.89-0.96) and increased mortality (odds ratio, 1.09; 95% CI, 1.05-1.12). Conclusions: Women with CS were less likely to be treated at a hub or transferred to a hub, had higher in-hospital mortality, and had a lower likelihood of receiving CS-related procedures than men. Further research is needed to understand sex-specific gaps in CS outcomes.

Randomized Trials of Renal Denervation for Uncontrolled Hypertension: An Updated Meta-Analysis.

BACKGROUND: Despite optimal medical therapy, a significant proportion of patients' blood pressure remains uncontrolled. Catheter-based renal denervation (RDN) has been proposed as a potential intervention for uncontrolled hypertension. We conducted an updated meta-analysis to assess the efficacy and safety of RDN in patients with uncontrolled hypertension, with emphasis on the differential effect of RDN in patients on and off antihypertensive medications. METHODS AND RESULTS: Online databases were searched to identify randomized clinical trials comparing efficacy and safety of RDN versus control in patients with uncontrolled hypertension. Subgroup analyses were conducted for sham-controlled trials and studies that used RDN devices that have gained or are currently seeking US Food and Drug Administration approval. Fifteen trials with 2581 patients (RDN, 1723; sham, 858) were included. In patients off antihypertensive medications undergoing RDN, a significant reduction in 24-hour ambulatory (-3.70 [95% CI, -5.41 to -2.00] mm Hg), office (-4.76 [95% CI, -7.57 to -1.94] mm Hg), and home (-3.28 [95% CI, -5.96 to -0.61] mm Hg) systolic blood pressures was noted. In patients on antihypertensive medications, a significant reduction was observed in 24-hour ambulatory (-2.23 [95% CI, -3.56 to -0.90] mm Hg), office (-6.39 [95% CI, -11.49 to -1.30]), home (-6.08 [95% CI, -11.54 to -0.61] mm Hg), daytime (-2.62 [95% CI, -4.14 to -1.11]), and nighttime (-2.70 [95% CI, -5.13 to -0.27]) systolic blood pressures, as well as 24-hour ambulatory (-1.16 [95% CI, -1.96 to -0.35]), office (-3.17 [95% CI, -5.54 to -0.80]), and daytime (-1.47 [95% CI, -2.50 to -0.27]) diastolic blood pressures. CONCLUSIONS: RDN significantly lowers blood pressure in patients with uncontrolled hypertension, in patients off and on antihypertensive medications, with a favorable safety profile. The efficacy of RDN was consistent in sham-controlled trials and contemporary trials using US Food and Drug Administration-approved devices.

Nationwide trends of balloon pulmonary angioplasty and pulmonary thromboendarterectomy for chronic thromboembolic pulmonary hypertension (2012-2019).

Chronic thromboembolic pulmonary hypertension (CTEPH) is a sequela of a pulmonary embolus that occurs in approximately 1%-3% of patients. Pulmonary thromboendoarterectomy (PTE) can be a curative procedure, but balloon pulmonary angioplasty (BPA) has emerged as an option for poor surgical candidates. We used the National Inpatient Sample to query patients who underwent PTE or BPA between 2012 and 2019 with CTEPH. The primary outcome was a composite of in-hospital mortality, myocardial infarction, stroke, tracheostomy, and prolonged mechanical ventilation. Outcomes were compared between low- and high-volume centers, defined as 5 and 10 procedures per year for BPA and PTE, respectively. During our study period, 870 BPA and 2395 PTE were performed. There was a 328% relative increase in the number of PTE performed during the study period. Adverse events for BPA were rare. There was an increase in the primary composite outcome for low-volume centers compared to high-volume centers for PTE (24.4% vs. 12.1%, p = 0.003). Patients with hospitalizations for PTE in low-volume centers were more likely to have prolonged mechanical ventilation (20.0%% vs. 7.2%, p < 0.001) and tracheostomy (7.8% vs. 2.6%, p = 0.017). In summary, PTE rates have been rising over the past 10 years, while BPA rates have remained stable. While adverse outcomes are rare for BPA, patients with hospitalizations at low-volume centers for PTE were more likely to have adverse outcomes. For patients undergoing treatment of CTEPH with BPA or PTE, referral to high-volume centers with multidisciplinary teams should be encouraged for optimal outcomes.

Opportunities and Limitations of Renal Denervation: Where Do We Stand?

Hypertension is a primary contributor to cardiovascular disease, and the leading risk factor for loss of quality adjusted life years. Up to 50% of the cases of hypertension in the United States remain uncontrolled. Additionally, 8%-18% of the hypertensive population have resistant hypertension; uncontrolled pressure despite 3 different antihypertensive agents. Recently, catheter-based percutaneous renal denervation emerged as a method for ablating renal sympathetic nerves for difficult-to-control hypertension. Initial randomized (non-sham) trials and registry analyses showed impressive benefit, but the first sham-controlled randomized controlled trial using monopolar radiofrequency ablation showed limited benefit. With refinement of techniques to include multipolar radiofrequency, ultrasound denervation, and direct ethanol injection, randomized controlled trials demonstrated significant blood pressure improvement, leading to US Food and Drug Administration approval of radiofrequency- and ultrasound-based denervation technologies. In this review article, we summarize the major randomized sham-controlled trials and societal guidelines regarding the efficacy and safety of renal artery denervation for the treatment of uncontrolled hypertension.

Impella Versus Intra-Aortic Balloon Pump in Patients With Cardiogenic Shock Treated With Venoarterial Extracorporeal Membrane Oxygenation: An Observational Study.

BACKGROUND: Venoarterial extracorporeal membrane oxygenation (VA-ECMO) is increasingly used for patients with cardiogenic shock. Although Impella or intra-aortic balloon pump (IABP) is frequently used for left ventricular unloading (LVU) during VA-ECMO treatment, there are limited data on comparative outcomes. We compared outcomes of Impella and IABP for LVU during VA-ECMO. METHODS AND RESULTS: Using the Nationwide Readmissions Database between 2016 and 2020, we analyzed outcomes in 3 groups of patients with cardiogenic shock requiring VA-ECMO based on LVU strategies: extracorporeal membrane oxygenation (ECMO) only, ECMO with IABP, and ECMO with Impella. Of 15 980 patients on VA-ECMO, IABP and Impella were used in 19.4% and 16.4%, respectively. The proportion of patients receiving Impella significantly increased from 2016 to 2020 (6.5% versus 25.8%; P-trend<0.001). In-hospital mortality was higher with ECMO with Impella (54.8%) compared with ECMO only (50.4%) and ECMO with IABP (48.4%). After adjustment, ECMO with IABP versus ECMO only was associated with lower in-hospital mortality (adjusted odds ratio [aOR], 0.83; P=0.02). ECMO with Impella versus ECMO only had similar in-hospital mortality (aOR, 1.09; P=0.695) but was associated with more bleeding (aOR, 1.21; P=0.007) and more acute kidney injury requiring hemodialysis (aOR, 1.42; P<0.001). ECMO with Impella versus ECMO with IABP was associated with greater risk of acute kidney injury requiring hemodialysis (aOR, 1.49; P=0.002), higher in-hospital mortality (aOR, 1.32; P=0.001), and higher 40-day mortality (hazard ratio, 1.25; P<0.001). CONCLUSIONS: In patients with cardiogenic shock on VA-ECMO, LVU with Impella, particularly with 2.5/CP, was not associated with improved survival at 40 days but was associated with increased adverse events compared with IABP. More data are needed to assess Impella platform-specific comparative outcomes of LVU.

Trends in the Incidence of Cardiogenic Shock, and Utilization of Mechanical Circulatory Support in Myocarditis: Insights from the National Inpatient Sample 2016 to 2019.

A subset of patients with myocarditis present with cardiogenic shock. There is a lack of contemporary data assessing the use of mechanical circulatory support (MCS) in these patients. Myocarditis hospitalizations were analyzed using the National Inpatient Sample between 2016 and 2019. Characteristics of patients with and without cardiogenic shock were assessed. Trends in mortality, MCS, right-sided cardiac catheterization (RHC) and endomyocardial biopsy were evaluated. The impact of RHC on consequent MCS and mortality was studied. A total of 38,300 hospitalizations for myocarditis were included in the study, of which 3,490 hospitalizations (9.1%) had cardiogenic shock. Patients with cardiogenic shock were older (p <0.001) and had more chronic kidney disease and atrial fibrillation. Between 2016 and 2019, there was an increase in myocarditis admissions but no difference in rates of cardiogenic shock and mortality and the use of extracorporeal membrane oxygenation, percutaneous ventricular assist devices, intra-aortic balloon pumps, left ventricular assist devices, and cardiac transplant. The most common form of MCS used in myocarditis was extracorporeal membrane oxygenation. The rates of RHC (p = 0.02) and endomyocardial biopsy (p = 0.03) increased over time. Patients who underwent RHC were more likely to receive mechanical support, and in patients with shock, RHC was associated with lower mortality (adjusted odds ratio 0.34, p <0.01). Myocarditis admissions increased over time but with no increase in the rates of cardiogenic shock and MCS. In patients with cardiogenic shock, RHC resulted in lower mortality.

Mortality of patients with ST-segment-elevation myocardial infarction without standard modifiable risk factors among patients without known coronary artery disease: Age-stratified and sex-related analysis from nationwide readmissions database 2010-2014.

Objective: The proportion of ST-segment elevation myocardial infarction (STEMI) patients without standard modifiable risk factors (SMuRFs: hypertension, diabetes, hypercholesterolemia and smoking) has increased over time. The absence of SMuRFs is known to be associated with worse outcomes, but its association with age and sex is uncertain. We sought to evaluate the association between age and sex with the outcomes of post-STEMI patients without SMuRFs among patients without preexisting coronary artery disease. Methods: Patients who underwent primary PCI for STEMI were identified from the Nationwide Readmission Database of the United States. Clinical characteristics, in-hospital, and 30-day outcomes in patients with or without SMuRFs were compared in men versus women and stratified into five age groups. Results: Between January 2010 and November 2014, of 474,234 patients who underwent primary PCI for STEMI, 52,242 (11.0%) patients did not have SMuRFs. Patients without SMuRFs had higher in-hospital mortality rates than those with SMuRFs. Among those without SMuRFs, the in-hospital mortality rate was significantly higher in women than men (10.6% vs 7.3%, p<0.001), particularly in older age groups. The absence of SMuRFs was associated with higher 30-day readmission-related mortality rates (0.5% vs 0.3% with SMuRFs, p<0.001). Among patients without SMuRFs, women had a higher 30-day readmission-related mortality rates than men (0.6% vs 0.4%, p<0.001). After multivariable adjustment, the increased rates of in-hospital (odds ratio 1.89 (95% CI 1.72 to 2.07) and 30-day readmission-related mortality (hazard ratio 1.30 (95% CI 1.01 to 1.67)) in patients without SMuRFs remained significant. Conclusions: STEMI patients without SMuRFs have a significantly higher risk of in-hospital and 30-day mortality than those with SMuRFs. Women and older patients without SMuRFs experienced significantly higher in-hospital and 30-day readmission-related mortality.

Feasibility and Safety of Impella-Assisted High-Risk PCI Before TAVR in Patients With Severe Aortic Stenosis.

Background: There are limited data on the feasibility of Impella-assisted percutaneous coronary intervention (PCI) in patients with severe aortic stenosis (AS) undergoing transcatheter aortic valve replacement (TAVR). Methods: To assess the feasibility of the Impella-assisted PCI in patients with severe symptomatic AS, we retrospectively reviewed the medical records to identify patients who were electively admitted for Impella-assisted PCI with a subsequent TAVR at Weill Cornell Medical Center from 2016 to 2021. Results: During the study period, 15 patients were identified to be eligible for the study, but the Impella failed to cross the aortic valve in 1 patient despite a concomitant balloon aortic valvuloplasty requiring a switch to an intra-aortic balloon pump to assist PCI. A total of 14 patients underwent successful PCI with the Impella CP and were included in the analysis. The median age was 89 years, and women accounted for 43% of the cohort. The median aortic valve area and mean gradient were 0.85 cm2 and 40 mm Hg, respectively, with a median left ventricular ejection fraction of 51%. The median SYNTAX score was 13. The left main stent was placed in 6 patients (43%), with a rotational atherectomy performed in 10 patients (71%). The balloon aortic valvuloplasty was performed in 2 patients before Impella placement. The TAVR was performed in all 14 patients on a median post-Impella-assisted PCI day of 25. No procedural complications were noted post-TAVR with no in-hospital or 30-day death. Conclusions: In this single-center study of patients with severe AS, the elective Impella-assisted high-risk PCI was feasible and safe before TAVR in selected patients.

Sex-Based Differences in 30-Day Readmissions After Cardiac Arrest: Analysis of the Nationwide Readmissions Database.

Background There are limited data on the sex-based differences in the outcome of readmission after cardiac arrest. Methods and Results Using the Nationwide Readmissions Database, we analyzed patients hospitalized with cardiac arrest between 2010 and 2015. Based on International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM) codes, we identified comorbidities, therapeutic interventions, and outcomes. Multivariable logistic regression was performed to assess the independent association between sex and outcomes. Of 835 894 patients, 44.4% (n=371 455) were women, of whom 80.7% presented with pulseless electrical activity (PEA)/asystole. Women primarily presented with PEA/asystole (80.7% versus 72.4%) and had a greater comorbidity burden than men, as assessed using the Elixhauser Comorbidity Score. Thirty-day readmission rates were higher in women than men in both PEA/asystole (20.8% versus 19.6%) and ventricular tachycardia/ventricular fibrillation arrests (19.4% versus 17.1%). Among ventricular tachycardia/ventricular fibrillation arrest survivors, women were more likely than men to be readmitted because of noncardiac causes, predominantly infectious, respiratory, and gastrointestinal illnesses. Among PEA/asystole survivors, women were at higher risk for all-cause (adjusted odds ratio [aOR], 1.07; [95% CI, 1.03-1.11]), cardiac-cause (aOR, 1.15; [95% CI, 1.06-1.25]), and noncardiac-cause (aOR, 1.13; [95% CI, 1.04-1.22]) readmission. During the index hospitalization, women were less likely than men to receive therapeutic procedures, including coronary angiography and targeted therapeutic management. While the crude case fatality rate was higher in women, in both ventricular tachycardia/ventricular fibrillation (51.8% versus 47.4%) and PEA/asystole (69.3% versus 68.5%) arrests, sex was not independently associated with increased crude case fatality after adjusting for differences in baseline characteristics. Conclusions Women are at increased risk of readmission following cardiac arrest, independent of comorbidities and therapeutic interventions.

Cardiovascular and Limb Events Following Endovascular Revascularization Among Patients ≥65 Years Old: An American College of Cardiology PVI Registry Analysis.

Background We aimed to characterize the occurrence of major adverse cardiovascular and limb events (MACE and MALE) among patients with peripheral artery disease (PAD) undergoing peripheral vascular intervention (PVI), as well as associated factors in patients with chronic limb threatening ischemia (CLTI). Methods and Results Patients undergoing PVI in the American College of Cardiology's (ACC) National Cardiovascular Data Registry's PVI Registry who could be linked to Centers for Medicare and Medicaid Services data were included. The primary outcomes were MACE, MALE, and readmission within 1 month and 1 year following index CLTI-PVI or non-CLTI-PVI. Cox proportional hazards regression was used to identify factors associated with the development of the primary outcomes among patients undergoing CLTI-PVI. There were 1758 (49.7%) patients undergoing CLTI-PVI and 1779 (50.3%) undergoing non-CLTI-PVI. By 1 year, MACE occurred in 29.5% of patients with CLTI (n=519), and MALE occurred in 34.0% of patients with CLTI (n=598). By 1 year, MACE occurred in 8.2% of patients with non-CLTI (n=146), and MALE occurred in 26.1% of patients with non-CLTI (n=465). Predictors of MACE at 1 year in CLTI-PVI included end-stage renal disease on hemodialysis, congestive heart failure, prior CABG, and severe lung disease. Predictors of MALE at 1 year in CLTI-PVI included treatment of a prior bypass graft, profunda femoral artery treatment, end-stage renal disease on hemodialysis, and treatment of a previously treated lesion. Conclusions Patients ≥65 years old undergoing PVI experience high rates of MACE and MALE. A range of modifiable and non-modifiable patient factors, procedural characteristics, and medications are associated with the occurrence of MACE and MALE following CLTI-PVI.

Hospital market concentration and the use of mechanical circulatory support devices in acute myocardial infarction complicated by cardiogenic shock.

BACKGROUND: As health care markets in the United States have become increasingly consolidated, the role of market concentration on physician treatment behavior remains unclear. In cardiology, specifically, there has been evolving treatment of acute myocardial infarction complicated by cardiogenic shock (AMI-CS) with increasing use of mechanical circulatory support (MCS). However, there remains wide variation in it use. The role of market concentration in the utilization of MCS in AMI-CS is unknown. We examined the use of MCS in AMI-CS and its effect on outcomes between competitive and concentrated markets. METHODS AND RESULTS: We used the National Inpatient Sample to query patients admitted with AMI-CS between 2003 and 2009. The primary study outcome was the use of mechanical circulatory support. The primary study exposure was market concentration, measured using the Herfindahl-Hirschman Index, which was used to classify markets as unconcentrated (competitive), moderately concentrated, and highly concentrated. Baseline characteristics, procedures, and outcomes were compared for patients in differently concentrated markets. Multivariable logistic regression was used to examine the association between HHI and use of MCS. RESULTS: There were 32,406 hospitalizations for patients admitted with AMI-CS. Patients in unconcentrated markets were more likely to receive MCS than in highly concentrated markets (unconcentrated 46.8% [5087/10,873], moderately concentrated 44.9% [2933/6526], and high concentrated 44.5% [6676/15,007], p < 0.01). Multivariable regression showed that patients in more concentrated markets had decreased use of MCS in patients in later years of the study period (2009, OR 0.64, 95% CI 0.44-0.94, p = 0.02), with no effect in earlier years. There was no significant difference in in-hospital mortality. CONCLUSION: Multivariable analysis did not show an association with market concentration and use of MCS in AMI-CS. However, subgroup analysis did show that competitive hospital markets were associated with more frequent use of MCS in AMI-CS as frequency of utilization increased over time. Further studies are needed to evaluate the effect of hospital market consolidation on the use of MCS and outcomes in AMI-CS.

Racial Disparities in Access to High-Volume Mitral Valve Transcatheter Edge-to-Edge Repair Centers.

Background: Severe mitral regurgitation is a progressive disease associated with high morbidity and mortality, and frequent readmissions for heart failure. Surgical mitral valve repair or replacement has been the gold-standard treatment; however, advances in transcatheter edge-to-edge repair (TEER) have provided alternatives for high-risk surgical patients. There are no data on racial disparities in access to high-volume TEER centers. Methods: Data on TEER hospitalizations from New York, New Jersey, Maryland, North Carolina, Washington, Colorado, Arizona, and Florida were analyzed using the State Inpatient Databases for 2016. The baseline characteristics of patients who underwent TEER at high- (≥25 procedures per year) and low-volume centers were identified. The association between race and the likelihood of undergoing TEER at high-volume centers was assessed. The secondary outcomes were mortality and the frequency of home discharges. Results: Of 1567 patients included in the analysis, 1129 underwent TEER at high-volume centers. Patients treated at high-volume centers had a higher prevalence of chronic kidney disease and congestive heart failure. Black and Hispanic patients were 59% (adjusted odds ratio [OR], 0.41; P < .001) and 51% (adjusted OR, 0.49; P < .001) less likely to undergo TEER at high-volume centers, respectively, compared with White patients. Hispanic patients were 3 times more likely to die during index admission than White patients (adjusted OR, 3.32; P = .027). There was geographic clustering of TEER centers, and a higher ratio of White patients to minority patients in zip codes with high-volume TEER centers. Conclusions: Racial minorities patients, particularly Black and Hispanic patients, are less likely to undergo TEER at high-volume centers. Hispanic patients experience higher rates of in-hospital mortality after TEER than White patients.