Efficacy and Safety of Dapagliflozin in Patients With Acute Heart Failure.

BACKGROUND: The primary goals during acute heart failure (AHF) hospitalization are decongestion and guideline-directed medical therapy (GDMT) optimization. Unlike diuretics or other GDMT, early dapagliflozin initiation could achieve both AHF goals. OBJECTIVES: The authors aimed to assess the diuretic efficacy and safety of early dapagliflozin initiation in AHF. METHODS: In a multicenter, open-label study, 240 patients were randomized within 24 hours of hospital presentation for hypervolemic AHF to dapagliflozin 10 mg once daily or structured usual care with protocolized diuretic titration until day 5 or hospital discharge. The primary outcome, diuretic efficiency expressed as cumulative weight change per cumulative loop diuretic dose, was compared across treatment assignment using a proportional odds model adjusted for baseline weight. Secondary and safety outcomes were adjudicated by a blinded committee. RESULTS: For diuretic efficiency, there was no difference between dapagliflozin and usual care (OR: 0.65; 95% CI: 0.41-1.02; P = 0.06). Dapagliflozin was associated with reduced loop diuretic doses (560 mg [Q1-Q3: 260-1,150 mg] vs 800 mg [Q1-Q3: 380-1,715 mg]; P = 0.006) and fewer intravenous diuretic up-titrations (P ≤ 0.05) to achieve equivalent weight loss as usual care. Early dapagliflozin initiation did not increase diabetic, renal, or cardiovascular safety events. Dapagliflozin was associated with improved median 24-hour natriuresis (P = 0.03) and urine output (P = 0.005), expediting hospital discharge over the study period. CONCLUSIONS: Early dapagliflozin during AHF hospitalization is safe and fulfills a component of GDMT optimization. Dapagliflozin was not associated with a statistically significant reduction in weight-based diuretic efficiency but was associated with evidence for enhanced diuresis among patients with AHF. (Efficacy and Safety of Dapagliflozin in Acute Heart Failure [DICTATE-AHF]; NCT04298229).

Using Arterial Recoil for Large Bore Access Closure After Impella Assist Device Removal.

The use of Impella assist device for high-risk percutaneous coronary interventions and cardiogenic shock has increased in the last decade and requires a large bore arterial access (LBA). However, LBA closure following Impella removal is associated with significant complications. Herein, we describe the safety and efficacy of a novel method of LBA closure using arterial recoil following Impella removal. We performed a retrospective review of electronic medical records of patients who underwent LBA closure using this method from July 1, 2018 to June 30, 2022. The procedure involves controlled downsizing of the arterial sheath from 12 French (Fr) to 6 Fr catheters with intermittent compression to allow patent hemostasis facilitated by arterial recoil. Baseline characteristics and outcomes including closure success, immediate/delayed bleeding, and access site complications were included. Of 103 patients with Impella placement, 20 (19%) underwent LBA closure with this method. Patients were predominantly male (80%) and White (55%) with a mean age of 65 ± 16 years. After downsizing of the femoral sheath to 6 Fr, 14 patients underwent manual compression, 3 patients had a 6 Fr catheter left in place to maintain access, and 3 patients underwent placement of a Perclose or Vascade device. Successful LBA closure was performed in all patients with no immediate or delayed bleeding complications. Five patients (25%) died inpatient; the deaths were unrelated to complications of Impella removal. In conclusion, LBA closure post-Impella removal with this novel method was safe and effective. Further prospective studies are needed to ascertain its comparative efficacy.

Left Atrial-Veno Arterial Extracorporeal Membrane Oxygenation as a Bridge to Surgery for Endocarditis-Related Acute Severe Aortic Regurgitation.

Mechanical circulatory support for cardiogenic shock complicated by acute severe aortic regurgitation poses a unique challenge for traditional veno arterial extracorporeal membrane oxygenation (ECMO) because of rapidly rising left ventricular pressures accentuated by the increased afterload from retrograde flow in femoral cannulation. This process necessitates rapid left ventricular unloading while also allowing for adequate native left ventricular function. Herein, we describe a case of cardiogenic and septic shock secondary to methicillin-resistant Staphylococcus aureus complicated by acute severe aortic regurgitation temporized by left atrial-veno arterial (LA-VA) ECMO via the Livanova TandemHeart system. Left ventricular unloading created a window of hemodynamic stability allowing for optimization of multiorgan failure and infectious source control before surgical aortic valve replacement.

Ventilatory Failure And Pulmonary Embolism In Covid-19 Requiring Enhanced Venous Drainage For Extracorporeal Membrane Oxygenation.

COVID-19 infection manifests as a spectrum of respiratory and vascular complications, including acute respiratory distress syndrome (ARDS) and pulmonary embolism. Herein, we describe a case of a healthy young male who presented with ARDS refractory to mechanical ventilation and concomitant bilateral pulmonary emboli managed with extracorporeal membrane oxygenation (ECMO) and embolectomy. The embolectomy and initial veno-venous ECMO configuration failed to correct the patient's hypoxemia despite maximal flows. This was thought to be due to a high-output state secondary to vasodilatory shock preventing adequate drainage from the existing single drainage ECMO cannulation, following which a second venous cannula was placed to form a unique veno-veno-venous ECMO circuit that resolved the persistent hypoxemia. The case underscores the importance of identifying embolic events and vasodilatory shock in COVID-19 patients, both of which need to be addressed simultaneously to avoid worsening right ventricular failure (via both mechanical and hypoxia-driven pathways) and the resulting veno-arterial ECMO along with its associated complications.

Temporal Trends and Outcomes of Implantable Cardioverter Defibrillators in Heart Failure and Chronic Kidney Disease in the United States.

Chronic kidney disease (CKD) and hemodialysis increase the risk of sudden cardiac death (SCD) in heart failure (HF); however, national trends in utilization and outcomes of implantable cardioverter-defibrillator (ICD) in this population remain unknown. We sought to evaluate the utilization and outcomes of ICD therapy in HF patients with CKD and end-stage renal disease (ESRD) using the National Inpatient Sample from 2009 to 2018. Hospitalizations with a discharge diagnosis of systolic HF and ICD implantation were identified and stratified by stages of kidney disease. A total of 281,219 systolic HF hospitalizations who underwent ICD implantation were included. A significant decrease in inpatient ICD implantation was observed over the past decade (3.7% in 2009 to 1.1% in 2018) regardless of renal impairment. In-hospital mortality was highest in ESRD, followed by CKD compared with patients with no CKD. Length of hospital stay and hospitalization costs were also significantly higher in patients with CKD and ESRD. The overall utilization of inpatient ICD implantation has decreased in systolic HF patients and inpatient ICD placement in CKD is associated with an increased risk of mortality and adverse clinical outcomes. This indicates that patients with renal impairment and HF represent a sicker cohort than the general HF population.

Acute Left Ventricular Assist Device Failure From Outflow Graft Dissection Flap Successfully Treated With Stent Placement.

Outflow graft obstruction (OGO) is a potentially fatal complication of left ventricular assist device (LVAD) implantation. Common causes include graft kinking, luminal stenosis, and graft thrombosis. We describe a case of a 51-year-old female who presented with acute LVAD failure and cardiogenic shock. Initial imaging revealed OGO without luminal stenosis following which she was she was empirically treated for graft thrombosis with anticoagulation and catheter-based thrombolytic therapy with no success. Further imaging in the catheterization laboratory revealed a potential neointimal flap dissection acting as a one-way valve. A stent was successfully placed across the outflow graft with immediate resolution of cardiogenic shock. The case emphasizes the importance of including neointimal flap as a differential for OGO in acute LVAD failure, especially in cases where thrombolytic therapy fails to correct hemodynamic compromise.

Distal Trans-radial Access Compared to Conventional Trans-radial Access in Coronary Interventions: A Meta-analysis.

BACKGROUND: Distal trans-radial access (dTRA) is a novel technique of arterial cannulation in coronary interventions. The comparative efficacy of dTRA and conventional trans-radial access (TRA) in attenuating peri-procedural complications is unknown. METHODS: Embase and PubMed/MEDLINE were searched from their inception until June 25, 2022, for randomized clinical trials. Outcomes included were radial artery occlusion (RAO), radial artery spasm, hemostasis time, access time, unsuccessful cannulation, crossover rate, and early discharge after trans-radial stenting of coronary arteries (EASY) type I-III hematomas. Statistical analysis was conducted using the random effects model to derive risk ratios (RRs) and mean differences (MDs) with their corresponding 95% confidence intervals (CIs). RESULTS: A total of 6 randomized clinical trials comprising 3240 patients were included. Subjects were predominantly male (73%) and had a mean age of 66 years. The dTRA group had a lower risk of RAO [RR 0.43 (95% CI, 0.26-0.69); P = 0.0005; I 2 = 0%] and had a shorter hemostasis time [MD -22.85 min (95% CI, -39.06 to -6.65); P = 0.006; I 2 = 99%]. The dTRA group had a higher crossover rate [RR 3.04 (95% CI, 1.88-4.91); P = 0.00001; I 2 = 56%] and a longer access time [MD 0.68 min (95% CI, 0.17-1.18); P = 0.009; I 2 = 99%]. The TRA group had a lower rate of unsuccessful cannulation [RR 0.81 (95% CI, 0.70-0.95); P = 0.01; I 2 = 92%]. There was no significant difference between the groups for radial artery spasm and EASY type I-III hematomas. CONCLUSION: dTRA is a safe alternative to conventional TRA for coronary interventions with a lower risk of RAO. Future trials are required to further compare both approaches.

Infected chylopericardium: An unexpected cause of cardiac tamponade.

A 22-year-old immunocompetent female with a history of small pericardial effusion while infant presented with fever and hemodynamic collapse 4 days after facial trauma. She was found to have cardiac tamponade secondary to infected chylopericardium from bacterial translocation. We report this very unusual case and review of the literature on chylopericardium infections.

Multi-lead atrioventricular sequential pacing: A promising alternative to conventional temporary pacing techniques.

Temporary right ventricular pacing in unstable bradycardia and cardiovascular interventions is associated with atrioventricular dyssynchrony and reduced cardiac output. Currently, sequential atrioventricular pacing options are limited andnot routinely used. Herein, we discuss a novel, first in-human technique of temporary atrioventricular sequential pacing and how it compares to existing modalities of atrioventricular pacing.

Effects of bromocriptine in peripartum cardiomyopathy: a systematic review and meta-analysis.

Peripartum cardiomyopathy (PPCM) is a rare but potentially life-threatening form of heart failure (HF). Bromocriptine, a dopamine D2 agonist, has been used as an adjunctive treatment for PPCM with controversial benefits. A comprehensive literature search was conducted through June 2021. We included studies comparing the outcomes of PPCM with or without bromocriptine use. Pooled risk ratio (RR) with 95% confidence intervals (CI) and I2 statistics were calculated. Composite major adverse outcomes were defined by a composite of death, need for advanced HF therapies, persistent New York Heart Association (NYHA) functional class III/V, or left ventricular ejection fraction (LVEF) ≤ 35% at 6-month follow-up. LVEF recovery was defined by improvement of LVEF to more than 50%. Eight studies (two randomized-controlled, six observational) involving 593 PPCM patients were included. Bromocriptine use was associated with significantly higher survival (91.6% vs. 83.9%, RR 1.11 p = 0.02). Baseline LVEF was not significantly different between the groups. LVEF at follow-up was significantly higher in the bromocriptine group (53.3% vs. 41.8%, p < 0.001). There was no significant association between bromocriptine use and lower composite major adverse outcomes (13.7% vs. 33.3%, RR 0.60 p = 0.54) or LVEF recovery (46.9% vs. 46.8%, RR 0.94 p = 0.74). In conclusion, the addition of bromocriptine to standard HF treatment in PPCM was associated with significantly higher survival and higher LVEF improvement. No association with lower composite adverse clinical outcomes or LVEF recovery was seen. The findings, although encouraging, warrant larger randomized-controlled studies.

Torrential Mitral Regurgitation After Transcatheter Edge-to-Edge Mitral Valve Repair.

A patient with severe mitral regurgitation and chronic systolic heart failure taking inotropic support at home presents for transcatheter edge-to-edge mitral valve repair, complicated by torrential mitral regurgitation from damaged mitral leaflets requiring escalating mechanical circulatory support and ultimately expedited orthotopic heart transplantation. (Level of Difficulty: Intermediate.).

Pre-operative atrial fibrillation and early right ventricular failure after left ventricular assist device implantation: a systematic review and meta-analysis.

BACKGROUND: Right ventricular failure (RVF) remains a major cause of morbidity and mortality after left ventricular assist device (LVAD). Atrial fibrillation (AF) is known for its deleterious effects on cardiac function and hemodynamics. The association of pre-operative AF with the risk of early post-LVAD RVF has not been well described. METHOD: A comprehensive literature search was performed through April, 9 2021. Cohort studies comparing the risk of post-operative RVF and/or need for right ventricular assist device (RVAD) after LVAD in patients with or without AF were included. Pooled odds ratio (OR) with 95% confidence intervals (CI) and I2 statistic were calculated using the random-effects model. RESULTS: Six studies were included in the analysis. Post-operative RVF was reported in 5 studies (1,841 patients) and RVAD use was reported in 4 studies (1,355 patients). There is a non-significant trend toward a higher risk of post-operative RVF in the AF group (pooled OR=1.25, 95%CI=0.99-1.58). No significant association between AF and RVAD use is noted (pooled OR=1.17, 95%CI=0.82-1.66). CONCLUSIONS: Pre-operative AF is not significantly associated with higher risks of post-operative RVF and RVAD use after LVAD implantation, although the trend toward higher post-operative RVF is observed in patients with pre-operative AF. Additional research using a larger study population is warranted to better understand the association of pre-operative AF and the development of post-LVAD RVF.

Racial and ethnic disparities in coronary, vascular, structural, and congenital heart disease.

Cardiovascular disease (CVD) remains the leading cause of death in the United States. However, percutaneous interventional cardiovascular therapies are often underutilized in Blacks, Hispanics, and women and may contribute to excess morbidity and mortality in these vulnerable populations. The Society for Cardiovascular Angiography and Interventions (SCAI) is committed to reducing racial, ethnic, and sex-based treatment disparities in interventional cardiology patients. Accordingly, each of the SCAI Clinical Interest Councils (coronary, peripheral, structural, and congenital heart disease [CHD]) participated in the development of this whitepaper addressing disparities in diagnosis, treatment, and outcomes in underserved populations. The councils were charged with summarizing the available data on prevalence, treatment, and outcomes and elucidating potential reasons for any disparities. Given the huge changes in racial and ethnic composition by age in the United States (Figure 1), it was difficult to determine disparities in rates of diagnosis and we expected to find some racial differences in prevalence of disease. For example, since the average age of patients undergoing transcatheter aortic valve replacement (TAVR) is 80 years, one may expect 80% of TAVR patients to be non-Hispanic White. Conversely, only 50% of congenital heart interventions would be expected to be performed in non-Hispanic Whites. Finally, we identified opportunities for SCAI to advance clinical care and equity for our patients, regardless of sex, ethnicity, or race.

Phosphodiesterase-5 Inhibitors and Outcomes During Left Ventricular Assist Device Support: A Systematic Review and Meta-Analysis.

BACKGROUND: Phosphodiesterase-5 inhibitors (PDE5i) have been used to treat pulmonary hypertension and right ventricular failure in patients with left ventricular assist devices (LVAD). The effects of PDE5i on post-LVAD outcomes including hemocompatibility-related adverse events are not well-established. This systematic review and meta-analysis aims to evaluate the effects of PDE5i on post-LVAD outcomes. METHODS AND RESULTS: A comprehensive literature search was conducted using Pubmed and Embase databases from inception through November 25, 2020, to compare post-LVAD outcomes in patients with or without PDE5i use. Pooled odds ratio (OR) with 95% confidence intervals (CI) and I2 statistic were calculated. Thirteen observational studies were included in this analysis. The use of PDE5i was not significantly associated with lower postoperative right ventricular failure (OR 0.38, 95% CI 0.02-5.96, P = .41). There was no significant association between PDE5i and gastrointestinal bleeding (OR 1.23, 95% CI 0.76-1.98, P = .2), overall stroke (OR 0.60, 95% CI 0.21-1.68, P = .17), ischemic stroke (OR 0.61, 95% CI 0.09-4.07, P = .38), or pump thrombosis (OR 0.71, 95% CI 0.14-3.54, P = .46). CONCLUSIONS: Our meta-analysis showed no significant association between PDE5i and post-LVAD right ventricular failure. Despite the antiplatelet effects of PDE5i, there was no significant association between PDE5i and gastrointestinal bleeding, overall stroke, ischemic stroke, or pump thrombosis. Randomized controlled studies are warranted to evaluate the net benefits or harms of PDE5i in the LVAD population.

Impact of Atrial Fibrillation on In-Hospital Mortality and Thromboembolic Complications after Left Ventricular Assist Device Implantation.

The association between atrial fibrillation (AF) and thromboembolic (TE) complications in left ventricular assist device (LVAD) recipients is controversial, and there is paucity of large-scale data evaluating the impact of AF on early outcomes after device implantation. Using the National Inpatient Sample, we identified hospitalizations where patients underwent LVAD implantation from 2010 to 2015. Multivariate logistic regression was used to evaluate the association of AF on in-hospital outcomes. A total of 18,378 patients (41.7% with AF) underwent LVAD implantation. Patients with AF were older (59.9 vs. 54.0 years, p < 0.001), more commonly male (79.9 vs. 74.1%, p < 0.001), and had a greater burden of comorbidities as measured by the Elixhauser comorbidity index (7.2 vs. 6.3, p < 0.001). Patients with AF had less incidence of ischemic stroke (3.1 vs. 4.7%, p = 0.04, OR 0.68), hemorrhagic stroke (1.0 vs. 2.4%, p = 0.006, OR 0.43), and other systemic embolism (1.8 vs. 3.7%, p = 0.01, OR 0.55). There was no significant difference in the incidence of bleeding requiring transfusion between AF and no AF cohorts (29.3 vs. 24.2%, p = 0.09, OR 1.15). LOS was shorter in patients with AF (32.9 vs. 36.7 mean days, p < 0.001). Patients with AF had lower in-hospital mortality (8.9 vs. 14.9%, p < 0.001, OR 0.48). In a large real-world US cohort of patients undergoing LVAD implantation, a diagnosis of AF was common among device recipients. After adjustment for demographics and comorbidities, AF was associated with reduced TE events and in-hospital mortality.

Efficacy and safety of dapagliflozin in acute heart failure: Rationale and design of the DICTATE-AHF trial.

BACKGROUND: Dapagliflozin, a sodium-glucose cotransporter-2 inhibitor, reduces cardiovascular death and worsening heart failure in patients with chronic heart failure and reduced ejection fraction. Early initiation during an acute heart failure (AHF) hospitalization may facilitate decongestion, improve natriuresis, and facilitate safe transition to a beneficial outpatient therapy for both diabetes and heart failure. OBJECTIVE: The objective is to assess the efficacy and safety of initiating dapagliflozin within the first 24 hours of hospitalization in patients with AHF compared to usual care. METHODS: DICTATE-AHF is a prospective, multicenter, open-label, randomized trial enrolling a planned 240 patients in the United States. Patients with type 2 diabetes hospitalized with hypervolemic AHF and an estimated glomerular filtration rate of at least 30 mL/min/1.73m2 are eligible for participation. Patients are randomly assigned 1:1 to dapagliflozin 10 mg once daily or structured usual care until day 5 or hospital discharge. Both treatment arms receive protocolized diuretic and insulin therapies. The primary endpoint is diuretic response expressed as the cumulative change in weight per cumulative loop diuretic dose in 40 mg intravenous furosemide equivalents. Secondary and exploratory endpoints include inpatient worsening AHF, 30-day hospital readmission for AHF or diabetic reasons, change in NT-proBNP, and measures of natriuresis. Safety endpoints include the incidence of hyper/hypoglycemia, ketoacidosis, worsening kidney function, hypovolemic hypotension, and inpatient mortality. CONCLUSIONS: The DICTATE-AHF trial will establish the efficacy and safety of early initiation of dapagliflozin during AHF across both AHF and diabetic outcomes in patients with diabetes.

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.

Impact of Prior Coronary Artery Bypass Grafting in Patients ≥75 Years Old Presenting With Acute Myocardial Infarction (From the National Readmission Database).

Patients ≥75 years old presenting with acute myocardial infarction (AMI) have complex coronary anatomy in part due to prior coronary artery bypass grafting (CABG), percutaneous coronary interventions (PCI), calcific and valvular disease. Using the National Readmission Database from January 2016 to November 2017, we identified hospital admissions for acute myocardial infarction in patients ≥75 years old and divided them based on a history of CABG. We evaluated in-hospital outcomes, 30-day mortality, 30-day readmission and predictors of PCI in cohorts. Out of a total of 296,062 patients ≥75 years old presenting with an AMI, 42,147 (14%) had history of previous CABG. Most presented with a non-ST segment elevation myocardial infarction, and those with previous CABG had higher burden of co-morbidities and were more commonly man. The in-hospital mortality was significantly lower in those with previous CABG (6.7% vs 8.8%, adjusted odds ratio, 0.88, 95% confidence interval, 0.82 to 0.94). Medical therapy was more common in those with previous CABG and 30-day readmission rates were seen more frequently in those with prior CABG. Predictors of not undergoing PCI included previous PCI, female, older ager groups, heart failure, dementia, malignancy, and higher number of co-morbidities. In conclusion, in patients ≥75 years old with AMI the presence of prior CABG was associated with lower odds of in-hospital and 30-day mortality, as well as lower complications rates, and a decreased use of invasive strategies (PCI, CABG, and MCS). However, 30-day MACE readmission was higher in those with previous CABG.

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.