Background-Atrial fibrillation ablation has made tremendous progress with respect to innovation, efficacy, and safety.However, limited data exist regarding the burden and trends in adverse outcomes arising from this procedure. The aim of our study was to examine the frequency of adverse events attributable to atrial fibrillation (AF) ablation and the influence of operator and hospital volume on outcomes. Methods and Results-With the use of the Nationwide Inpatient Sample, we identified AF patients treated with catheter ablation. We investigated common complications including cardiac perforation and tamponade, pneumothorax, stroke, transient ischemic attack, vascular access complications (hemorrhage/hematoma, vascular complications requiring surgical repair, and accidental arterial puncture), and in-hospital death described with AF ablation, and we defined these complications by using validated International Classification of Diseases, Ninth Revision, Clinical Modification diagnosis codes. An estimated 93 801 AF ablations were performed from 2000 to 2010. The overall frequency of complications was 6.29% with combined cardiac complications (2.54%) being the most frequent. Cardiac complications were followed by vascular complications (1.53%), respiratory complications (1.3%), and neurological complications (1.02%). The in-hospital mortality was 0.46%. Annual operator (<25 procedures) and hospital volume (<50 procedures) were significantly associated with adverse outcomes. There was a small (nonsignificant) rise in overall complication rates. Conclusions-The overall complication rate was 6.29% in patients undergoing AF ablation. There was a significant association between operator and hospital volume and adverse outcomes. This suggests a need for future research into identifying the safety measures in AF ablations and instituting appropriate interventions to improve overall AF ablation outcomes.
To demonstrate the safety of transendocardial stem cell injection (TESI) with autologous MSCs and BMCs in patients with ICM.• To assess prespecified outcomes of efficacy.
Up to 20%-30% of patients hospitalized with coronavirus disease 2019 (COVID-19) have evidence of myocardial involvement. Acute cardiac injury in patients hospitalized with COVID-19 is associated with higher morbidity and mortality. There are no data on how acute treatment of COVID-19 may affect the convalescent phase or longterm cardiac recovery and function. Myocarditis from other viral pathogens can evolve into overt or subclinical myocardial dysfunction, and sudden death has been described in the convalescent phase of viral myocarditis. This raises concerns for patients recovering from COVID-19. Some patients will have subclinical and possibly overt cardiovascular abnormalities. Patients with ostensibly recovered cardiac function may still be at risk of cardiomyopathy and cardiac arrhythmias. Screening for residual cardiac involvement in the convalescent phase for patients recovered from COVID-19-associated cardiac injury is needed. The type of testing and therapies for post COVID-19 myocardial dysfunction will need to be determined. Therefore, now is the time to plan for appropriate registries and clinical trials to properly assess these issues and prepare for long-term sequelae of "post-COVID-19 cardiac syndrome."
Background—
Atrial fibrillation (AF) is the most common sustained cardiac arrhythmia. The associated morbidity and mortality make AF a major public health burden. Hospitalizations account for the majority of the economic cost burden associated with AF. The main objective of this study is to examine the trends of AF-related hospitalizations in the United States and to compare patient characteristics, outcomes, and comorbid diagnoses.
Methods and Results—
With the use of the Nationwide Inpatient Sample from 2000 through 2010, we identified AF-related hospitalizations using
International Classification of Diseases, 9th Revision, Clinical Modification
code 427.31 as the principal discharge diagnosis. Overall AF hospitalizations increased by 23% from 2000 to 2010, particularly in patients ≥65 years of age. The most frequent coexisting conditions were hypertension (60.0%), diabetes mellitus (21.5%), and chronic pulmonary disease (20.0%). Overall in-hospital mortality was 1%. The mortality rate was highest in the group of patients ≥80 years of age (1.9%) and in the group of patients with concomitant heart failure (8.2%). In-hospital mortality rate decreased significantly from 1.2% in 2000 to 0.9% in 2010 (29.2% decrease;
P
<0.001). Although there was no significant change in mean length of stay, mean cost of AF hospitalization increased significantly from $6410 in 2001 to $8439 in 2010 (24.0% increase;
P
<0.001).
Conclusions—
Hospitalization rates for AF have increased exponentially among US adults from 2000 to 2010. The proportion of comorbid chronic diseases has also increased significantly. The last decade has witnessed an overall decline in hospital mortality; however, the hospitalization cost has significantly increased.
Background
While human mesenchymal stem cells (hMSCs) have been tested in ischemic cardiomyopathy, few studies exist in chronic non-ischemic dilated cardiomyopathy (NIDCM).
Objectives
The POSEIDON-DCM trial is a randomized comparison of safety and efficacy of autologous (auto) vs. allogeneic (allo) bone marrow-derived hMSCs in NIDCM.
Methods
Thirty-seven patients were randomized to either allo- or auto-hMSCs in a 1:1 ratio. Patients were recruited between December 2011 and July 2015 at the University of Miami Hospital. Patients (age: 55.8 ± 11.2; 32% female) received hMSCs (100 million) by transendocardial stem cell injection (TESI) in ten left ventricular sites by NOGA Catheter. Treated patients were evaluated at baseline, 30 days, 3-, 6-, and 12-months for safety: serious adverse events (SAE), and efficacy endpoints: Ejection Fraction (EF), Minnesota Living with Heart Failure Questionnaire (MLHFQ), Six Minute Walk Test (6MWT), MACE, and immune-biomarkers. This trial is registered with ClinicalTrials.gov, #NCT01392625.
Results
There were no 30-day treatment-emergent (TE)-SAEs. 12-month SAE incidence was 28.2% (95% CI: 12.8, 55.1) in allo, and 63.5% (95% CI: 40.8, 85.7; p=0.1004) in auto. One allo-group patient developed an elevated donor specific cPRA. EF increased in allo by 8.0 units (95% Cl: 2.8, 13.2; p=0.004), and in auto: 5.4 units (95% Cl: −1.4, 12.1; p=0.116, allo vs. auto p=0.4887). 6MWT increased for allo: 37.0 meters (95% Cl: 2.0 to 72.0; p=0.04), but not auto: 7.3 meters (95% Cl: −47.8, 33.3; p=0.71, auto vs. allo p=0.0168). MLHFQ score decreased in allo (p=0.0022), and auto (p=0.463; p=0.172). The MACE rate was lower in allo vs. auto (p=0.0186). Tumor necrosis factor alpha (TNF-α) decreased (p=0.0001 for each), to a greater extent in allo vs. auto at six-months (p=0.05).
Conclusion
These findings demonstrate safety and support greater, clinically meaningful efficacy of allo-hMSC vs. auto-hMSC in NIDCM patients. Pivotal trials of allo-hMSCs are warranted based on these results.
Altered short-term fractal scaling properties of HR indicate an increased risk for cardiac mortality, particularly sudden cardiac death, in the random population of elderly subjects.
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