Safety and Efficacy of the Amplatzer Septal Occluder: A Systematic Review and Meta-Analysis.

OBJECTIVES: To assess the safety and efficacy of the Amplatzer Septal Occluder in the closure of secundum type atrial septal defects. BACKGROUND: The Amplatzer Septal Occluder (ASO; Abbott, St. Paul, MN) is an FDA-approved device for percutaneous closure of secundum type atrial septal defects (ASD). Previous small cohort trials have shown a favorable safety and technical efficacy profile. METHODS: We conducted a systemic review and meta-analysis of all prospective case series and controlled trials that evaluated the ASO's safety and implant efficacy. The primary endpoint was the technical success rate of implantations. Secondary outcomes included proportions of arrhythmias and embolism specific-adverse events. RESULTS: We included a total of 12 studies with 2972 patients. The ratio of device implantation was 2:1 by sex [female: male]. Pooled technical success rate of implantation was 98% (95% CI: 0.968-0.990, P < 0.01). The cumulative adverse event rate was 5.1% (95% CI: 0.035-0.068, P < 0.01), which included arrhythmia and embolism specific adverse event rates of 1.8% (95% CI: 0.007-0.032, P < 0.01) and 0.7% (95% CI: 0.002-0.013, P < 0.01), respectively. Sensitivity analysis did not significantly affect pooled outcomes for success rate and adverse events; both forest plot and Begg's and Egger's regression tests supported symmetricity. CONCLUSION: A high likelihood of technical success can be expected when implanting the ASO in secundum type ASDs. Adverse event rates are expected for one in twenty patients, and thus, our results support the safe use of ASO in secundum type ASDs closure. CONDENSED ABSTRACT: The AMPLATZER Septal Occluder is an FDA-approved device for percutaneous closure of secundum type atrial septal defects (ASD). We conducted a systemic review and meta-analysis of all prospective case series and controlled trials that evaluated the ASO's safety and implant efficacy. We included a total of 12 studies with 2972 patients. Pooled technical success rate of implantation was 98% (P < 0.01). The cumulative adverse event rate was 5.1% (P < 0.01), 1.8% (P < 0.01) rate of arrhythmias, and 0.7% (P < 0.01) rate of embolisms. A high likelihood of technical success can be expected with a low rate of adverse events.

Adverse events with HeartMate-3 Left ventricular assist device: Results from the Manufacturer and User Facility Device Experience (MAUDE) database.

None.

Characteristics, management, and outcomes among admissions for primary cardiac tumors: Results from the National Inpatient Sample.

INTRODUCTION: Primary cardiac tumors (PCT) are rare, and their contemporary outcomes are not well characterized in the literature. We assessed temporal trends in patient characteristics and management of admissions for PCT in US hospitals. METHODS: Admissions with the principal diagnoses of a PCT (benign neoplasm of heart: ICD-9 212.7, ICD-10 D15.1; malignant neoplasm of heart: ICD-9 164.1, ICD-10 C38.0) between 2006 and 2017 were extracted from the National Inpatient Sample. Trends in demographics and clinical profiles were evaluated. We conducted descriptive analyses on the cohort and compared outcomes between those managed medically and surgically. RESULTS: Between 2006 and 2017, 19,111 admissions had the primary diagnosis of a PCT. Of these, 91.1% were benign. Admissions were mostly female (65.0%), caucasian (72.0%), and aged more than 50 years (76.0%). The annual admission rate for PCT was similar from 2006 to 2017 (p trend > .05) and associated with congestive heart failure, diabetes, renal failure, and valvular lesions. PCTs were managed surgically in 12,811 (67.0%) of overall cases, 70.8% for benign and 28.3% for malignant tumors. Overall, the in-hospital mortality rate was 2.3%. Medically managed cases reported a 2.5% higher mortality (p < .001) than those surgically managed. Admissions with malignant tumors were more likely to expire during hospitalization than those with benign tumors (odds ratio, 9.75; 95% confidence interval 6.34-14.99; p < .001). CONCLUSION: Admissions for primary cardiac tumors were primarily women or in their fifth or sixth decade of life. Surgical intervention is more commonly practiced and is associated with better in-hospital survival.

Intermittent Recovery of Severe Acute Aortic Regurgitation Arising From Infective Endocarditis.

This case reports a 47-year-old male with a history of IV drug abuse, presenting with one week of left lower back pain. During the initial treatment, the patient became hemodynamically unstable, requiring vasopressor support. Transthoracic echocardiography (TTE) revealed a 1 cm x 1 cm aortic valve vegetation with severe aortic regurgitation and potential perforation of the valve leaflet. After hemodynamic stability was achieved, the patient left against medical advice, refusing urgent valvular surgery. Subsequent follow-up unveiled repeated recurrence of symptoms and surgical repair of the aortic valve.