Clinical outcomes among cardiogenic shock patients supported with high-capacity Impella axial flow pumps: A report from the Cardiogenic Shock Working Group.

BACKGROUND: The Impella 5.0 and 5.5 pumps (Abiomed, Danvers, MA) are large-bore transvalvular micro-axial assist devices used in cardiogenic shock (CS) for patients requiring high-capacity flow. Despite their increasing use, real-world data regarding indications, rates of utilization and clinical outcomes with this therapy are limited. The objective of our study was to examine clinical profiles and outcomes of patients in a contemporary, real-world CS registry of patients who received an Impella 5.0/5.5 alone or in combination with other temporary mechanical circulatory support (tMCS) devices. METHODS: The CS Working Group (CSWG) Registry includes patients from 34 US hospitals. For this analysis, data from patients who received an Impella 5.0/5.5 between 2020-2023 were analyzed. Use of Impella 5.0/5.5 with or without additional tMCS therapies, duration of support, adverse events and outcomes at hospital discharge were studied. Adverse events including stroke, limb ischemia, bleeding and hemolysis were not standardized by the registry but reported per individual CSWG Primary Investigator discretion. For those who survived, rates of native heart recovery (NHR) or heart replacement therapy (HRT) including heart transplant (HT), or durable ventricular assist device (VAD) were recorded. We also assessed outcomes based on shock etiology (acute myocardial infarction or MI-CS vs. heart failure-related CS or HF-CS). RESULTS: Among 6,205 patients, 754 received an Impella 5.0/5.5 (12.1%), including 210 MI-CS (27.8%) and 484 HF-CS (64.1%) patients. Impella 5.0/5.5 was used as the sole tMCS device in 32% of patients, while 68% of patients received a combination of tMCS devices. Impella cannulation sites were available for 524/754 (69.4%) of patients, with 93.5% axillary configuration. Survival to hospital discharge for those supported with an Impella 5.0/5.5 was 67%, with 20.4% NHR and 45.5% HRT. Compared to HF-CS, patients with MI-CS supported on Impella 5.0/5.5 had higher in-hospital mortality (45.2% vs 26.2%, p < 0.001) and were less likely to receive HRT (22.4% vs 56.6%, p < 0.001. For patients receiving a combination of tMCS during hospitalization, this was associated with higher rates of limb ischemia (9% vs. 3%, p < 0.01), bleeding (52% vs 33%, p < 0.01), and mortality (38% vs 25%; p < 0.001) compared to Impella 5.0/5.5 alone. Among Impella 5.0/5.5 recipients, the median duration of pump support was 12.9 days (IQR: 6.8-22.9) and longer in patients bridged to HRT (14 days; IQR: 7.7-28.4). CONCLUSIONS: In this multi-center cohort of patients with CS, use of Impella 5.0/5.5 was associated with an overall survival of 67.1% and high rates of HRT. Lower adverse event rates were observed when Impella 5.0/5.5 was the sole support device used. Further study is required to determine whether a strategy of early Impella 5.0/5.5 use for CS improves survival. CONDENSED ABSTRACT: High capacity Impella heart pumps are capable of provide up to 5.5 liter/min of flow while upper body surgical placement allows for ambulation. Patients with advanced cardiogenic shock from acute myocardial infarction or heart failure requiring temporary mechanical circulatory support may benefit from upfront use of Impella 5.5 to improve overall survival, including native heart recovery or successful bridge to durable left ventricular assist device surgery or heart transplantation.

The Wallet Biopsy: Medical Crowdfunding for Heart Transplantation.

Financial considerations continue to impact access to heart transplantation. Transplant recipients face various costs, including, but not limited to, the index hospitalization, immunosuppressive medications, and lodging and travel to appointments. In this study, we sought to describe the state of crowdfunding for individuals being evaluated for heart transplantation. Using the search term heart transplant, 1000 GoFundMe campaigns were reviewed. After exclusions, 634 (63.4%) campaigns were included. Most campaigns were in support of white individuals (57.8%), males (63.1%) and adults (76.7%). Approximately 15% of campaigns had not raised any funds. The remaining campaigns fundraised a median of $53.24 dollars per day. Of the patients, 44% were admitted at the time of the fundraising. Within the campaigns in the United States, the greatest proportions were in the Southeast United States in non-Medicaid expansion states. These findings highlight the significant financial toxicities associated with heart transplantation and the need for advocacy at the governmental and payer levels to improve equitable access and coverage for all.

Machine learning to define phenotypes and outcomes of patients hospitalized for heart failure with preserved ejection fraction: Findings from ASCEND-HF.

BACKGROUND: Heart Failure with Preserved Ejection Fraction (HFpEF) is a heterogenous disease with few therapies proven to provide clinical benefit. Machine learning can characterize distinct phenotypes and compare outcomes among patients with HFpEF who are hospitalized for acute HF. METHODS: We applied hierarchical clustering using demographics, comorbidities, and clinical data on admission to identify distinct clusters in hospitalized HFpEF (ejection fraction >40%) in the ASCEND-HF trial. We separately applied a previously developed latent class analysis (LCA) clustering method and compared in-hospital and long-term outcomes across cluster groups. RESULTS: Of 7141 patients enrolled in the ASCEND-HF trial, 812 (11.4%) were hospitalized for HFpEF and met the criteria for complete case analysis. Hierarchical Cluster 1 included older women with atrial fibrillation (AF). Cluster 2 had elevated resting blood pressure. Cluster 3 had young men with obesity and diabetes. Cluster 4 had low resting blood pressure. Mortality at 180 days was lowest among Cluster 3 (KM event-rate 6.2 [95% CI: 3.5, 10.9]) and highest among Cluster 4 (18.8 [14.6, 24.0], P < .001). Twenty four-hour urine output was higher in Cluster 3 (2700 mL [1800, 3975]) than Cluster 4 (2100 mL [1400, 3055], P < .001). LCA also identified four clusters: A) older White or Asian women, B) younger men with few comorbidities, C) older individuals with AF and renal impairment, and D) patients with obesity and diabetes. Mortality at 180 days was lowest among LCA Cluster B (KM event-rate 5.5 [2.0, 10.3]) and highest among LCA Cluster C (26.3 [19.2, 35.4], P < .001). CONCLUSIONS: In patients hospitalized for HFpEF, cluster analysis demonstrated distinct phenotypes with differing clinical profiles and outcomes.

In-hospital outcomes after bariatric surgery in patients with heart failure.

Based on the largest publicly available all-payer inpatient database in the United States, this study sought to evaluate real-world outcomes after bariatric surgery among patients with heart failure.

Bicaval vs biatrial anastomosis techniques in orthotopic heart transplantation: An updated analysis of the UNOS database.

BACKGROUND: Despite the significant increase in the number of orthotopic heart transplants (OHT) performed yearly using the bicaval anastomosis technique, the impact on long-term outcomes remains a topic of debate. We analyzed the United Network for Organ Sharing (UNOS) database in search of the latest insight. METHODS: We performed a retrospective analysis of the UNOS database from 2006 to 2016 to identify first-time OHT recipients. Patients were primarily stratified according to anastomosis technique: bicaval vs biatrial. Baseline characteristics and clinical status were recorded. The primary endpoint was all-cause mortality. Secondary outcomes included need for permanent pacemaker (PPM), and length of hospital stay (LOS). The Kaplan-Meier method was used to compare survival between the two groups. The Cox proportional hazards regression model was used to conduct multivariable analysis. Statistical significance established at P < .0001. RESULTS: A total of 26 990 patients were identified. Of those who met the inclusion criteria (21 597), 16 573 (77%) underwent bicaval anastomosis. There were no major differences in baseline characteristics between the two groups. The bicaval anastomosis technique was not associated with increased survival during the study period (hazard ratio: 0.97; P = .3557), but the bicaval group required postoperative PPM less often (2.51% vs 5.79%, P < .0001) and was associated with shorter LOS on multivariable analysis. CONCLUSIONS: The use of either bicaval or biatrial anastomosis during OHT offers comparable survival advantage. Nonetheless, bicaval anastomosis is associated with less need for postoperative PPM and slightly shorter LOS.

Heart transplantation and in-hospital outcomes in adult congenital heart disease patients with Fontan: A decade nationwide analysis from 2004 to 2014.

INTRODUCTION: Treatment of adult congenital heart disease patients who require advanced therapies remains challenging due to high perioperative and wait-list mortality and limited donors. Patients palliated with Fontan are at the highest risk of early mortality due to multiorgan involvement and few centers able to safely transplant them. We sought to evaluate the early outcomes of heart transplants in these adult Fontan patients. METHODS: Using the Nationwide Inpatient Sample database, we identified all adults aged at least 18 years old who underwent heart transplantation across U.S. hospitals from 2004 to 2014. We then identified those with specific ICD-9 codes to include tricuspid atresia, hypoplastic left heart syndrome and common ventricle. Multivariate regression models were created to adjust for potential confounders. RESULTS: A total of 93 Fontan patients underwent heart transplant during the study time (0.5% of all heart transplants). Compared to non-Fontan heart transplantations, Fontan patients were younger, with a higher incidence of liver disease and coagulopathy. Fontan patients receiving heart transplant had higher mortality during transplant hospitalization compared to non-Fontan patients (26.3% vs 5.3% OR, 18.10, CI, 5.06-65.0 P < .001). Extracorporeal membrane oxygenator (ECMO) usage and bleeding were also higher in the Fontan cohort with an OR of 5.30 (P = .016) and 5.32 (P = .015) for ECMO and bleeding, respectively. The remaining outcomes were similar for both cohorts. CONCLUSION: Adults with Fontan palliation undergoing heart transplantation have exceptionally high inpatient mortality, which is nearly five times that of non-Fontan heart transplant recipients, perhaps related to a delayed referral, surgical complexity, and coexistent, underrecognized liver failure.

Renal Outcomes in Patients Bridged to Heart Transplant With a Left Ventricular Assist Device.

BACKGROUND: Patients with end-stage heart failure are increasingly being bridged to heart transplant (BTT) with mechanical circulatory support; however the association between a left ventricular assist device (LVAD) BTT strategy and posttransplant renal outcomes is unclear. The aim of this study was to analyze the association of LVAD BTT with the development of posttransplant renal failure using a large national registry. METHODS: We queried the 2009 to 2018 United Network for Organ Sharing registry for all adults undergoing first-time heart or heart-kidney transplantation and stratified patients by use of pretransplant durable LVAD. The primary outcome of interest was posttransplant renal failure, which was evaluated with multivariable logistic regression. RESULTS: Of 18,307 patients meeting inclusion criteria, 7887 were (43%) and 10,420 were not (57%) BTT with an LVAD. BTT patients had slightly better baseline renal function (estimated glomerular filtration rate, 68.7 vs 65.8 mL/min, P < .001) and were less likely to receive a heart-kidney transplant (2.7% vs 4.8%, P < .001). On multivariable logistic regression, LVAD BTT strategy was not independently associated with posttransplant renal failure (odds ratio, 1.13; 95% confidence interval, 0.86-1.49). Similarly LVAD BTT among patients with preoperative renal dysfunction was not associated with posttransplant renal failure (adjusted odds ratio, 1.40; 95% confidence interval, 0.91-2.18). CONCLUSIONS: BTT with an LVAD does not appear to be associated with worse renal outcomes regardless of baseline renal function. Furthermore, an LVAD BTT strategy in patients with chronic kidney disease may enable clinicians to identify candidates suitable for isolated heart transplantation without increasing their risk for posttransplant renal failure.

Predictors and etiologies of 30-day readmissions in patients with non-ST-elevation acute coronary syndrome.

BACKGROUND: Despite improvements in acute care and survival after non-ST-elevation acute coronary syndrome (NSTE-ACS) hospitalization, early readmissions remain common, and have significant clinical and financial impact. OBJECTIVES: Determine the predictors and etiologies of 30-day readmissions in NSTE-ACS. METHOD: The study cohort was derived from the National Readmission Database 2014 identifying patients with a primary diagnosis of NSTE-ACS using ICD9 code. RESULTS: We identified a total of 300,269 patients admitted with NSTE-ACS; 13.4% were readmitted within 30-day. The most common cause of readmission was heart failure (HF) (15.6%), followed by a recurrent myocardial infarction (MI) (10%). Predictors of increased readmissions were age ≥ 75 years (OR: 1.34, 95% CI: 1.30-1.39), female gender (OR 1.12, 95% CI 1.09-1.16), a Charlson Comorbidity Index (CCI) >3 (OR 2.11, 95% CI: 2.04-2.18), ESRD (OR 2.01, 95% CI 1.89-2.14), CKD (OR: 1.58, 95% CI: 1.51-1.64), length of stay ≥5 days (OR: 1.51, 95% CI 1.46-1.56) and adverse events during the index admission such as AKI (OR:1.31, 95% CI: 1.25-1.36), major bleeding (OR:1.20, 95% CI: 1.12-1.24); whereas admission to a teaching hospital (OR 0.92, 95% CI 0.89-0.95) and PCI (OR 0.70, 95% CI 0.67-0.72) were associated with less likelihood of 30-day readmission. CONCLUSION: Readmission rate at 30-days is high among NSTE-ACS patients and the most common readmission etiologies are HF and recurrent MI. A CCI more than 3 and ESRD were the most significant predictors for readmission; patients undergoing PCI had less odds of readmission.

Comparison of Utilization Trends, Indications, and Complications of Endomyocardial Biopsy in Native Versus Donor Hearts (from the Nationwide Inpatient Sample 2002 to 2014).

Native heart endomyocardial biopsy (NH-EMB) is an infrequently performed procedure. The objective of this study is to describe utilization trends, indications, and complications associated with NH-EMB in the United States and compare them with transplanted heart endomyocardial biopsy (TH-EMB). Using the Healthcare Cost and Utilization Project National Inpatient Sample database, we identified 71,105 adult patients undergoing EMB in the inpatient setting in participating hospitals from 2002 to 2014. A total of 20,770 (29%) were performed on NHs (mean age 52.2 ± 15.3, 61% men). Approximately half of patients were white and mean Charlson co-morbidity index was 1.97 ± 1.6. Common indications for NH-EMB included a suspected primary cardiomyopathy (disorder confined to the myocardium), heart failure without cardiogenic shock, and acute myocarditis. Less common indications included heart failure with cardiogenic shock, unexplained heart failure with ventricular tachycardia or high-degree atrioventricular block, and cardiac neoplasms. Complications included pericardial effusion (3.8%), third-degree atrioventricular block (2.7%), vascular complications (1.9%), and deep venous thrombosis (3.5%), in others. Predictors of complications included presence of a cardiac malignant neoplasm, use of hemodynamic support, heart failure with ventricular tachyarrhythmias, and female gender. Compared with NH-EMB, TH-EMB was associated with lower rates of pericardial effusion, third-degree atrioventricular block, ventricular tachyarrhythmias requiring cardioversion, and higher rates of deep venous thrombosis, infections, and pneumothorax. NH-EMB utilization is low in the United States and constitutes less than 1/3 of all EMBs performed.

Incidental finding of persistent left superior vena cava after 'bubble study' verification of central venous catheter.

We report a case of a patient with septic shock who underwent central venous catheter placement in the left internal jugular vein, and a bedside ultrasound 'bubble study' revealed venous cannulation. A chest X-ray postprocedure revealed concern for arterial system catheterisation. However, the possibility of a persistent left superior vena cava was discussed and confirmed with a formal transthoracic echocardiogram and CT. This case demonstrates the importance of ultrasound-guided visualisation of anatomical structures in real time during central venous catheterisation. Other similar cases from the literature are briefly described.

Transcatheter Mitral Valve Repair With MitraClip for Symptomatic Functional Mitral Valve Regurgitation.

Transcatheter edge-to-edge mitral valve repair (TMVr) with MitraClip has proved to be safe and effective for high-risk surgical patients with severe symptomatic degenerative mitral regurgitation. There is paucity of data regarding its use in functional mitral regurgitation (FMR). The objective of this study was to evaluate the use of MitraClip in patients with symptomatic moderate or severe FMR and a high surgical risk. Medical libraries were systematically searched for studies assessing the use of MitraClip for patients with symptomatic moderate or severe FMR and a high surgical risk. Studies reporting safety and efficacy outcomes at 12 months were included in the analysis. A total of 12 studies including 1,695 patients (age 73 [interquartile range [IQR] 70.5 to 74], 69.8% men, left ventricular ejection fraction 32.5% [IQR 29.5 to 36], New York Heart Association class II to IV) who underwent TMVr with MitraClip were included in the analysis. Acute procedural success was 89% (IQR 85.5 to 92). Ischemic cardiomyopathy was the most common cause of left ventricular dysfunction. Over 2/3 of patients had known coronary artery disease, 35% a previous myocardial infarction, and 38.5% had a previous cardiac surgery. Survival to hospital discharge was 98% (IQR 97 to 100) and 30-day survival 97% (IQR 96 to 98). Overall survival at 12 months was 82% (IQR 77 to 87). Mitral valve re-intervention at 12 months was infrequent (3%; IQR 2 to 6.5). In conclusion, our pooled analysis suggests that TMVr with MitraClip is feasible, safe, and carries a low rate of mitral valve re-intervention at 12 months in patients with symptomatic moderate or severe FMR and a high surgical risk.