Aortic Stenosis Risk in Rheumatoid Arthritis.

Importance: Although an increased risk of ischemic cardiovascular disease has been associated with rheumatoid arthritis (RA), the risk of aortic stenosis (AS) is unknown. Objective: To examine the risk of incident AS, aortic valve intervention, AS-related death, and risk factors for AS development in patients with RA. Design, Setting, and Participants: This cohort study linked data from the Veterans Health Administration (VHA) and Centers for Medicare & Medicaid Services from 2000 to 2019. Patients with RA were matched by age, sex, and VHA enrollment year with up to 10 patients without RA. The cohort was followed until incident AS, aortic valve intervention, or death. Data were analyzed from August 23, 2022, to March 3, 2023. Exposures: the primary exposure was the presence of RA, defined using validated RA algorithms. Main Outcomes and Measures: Aortic stenosis was defined as a composite of inpatient or outpatient diagnoses, surgical or transcatheter aortic valve replacement, or AS-related death using diagnostic and procedural codes. Risk of AS development was assessed with multivariable Cox proportional hazards models adjusted for race, ethnicity, smoking status, body mass index, rurality, comorbidities, and health care use. Results: The cohort included 73 070 patients with RA (64 008 [87.6%] males; mean [SD] age, 63.0 [11.9] years) matched with 639 268 patients without RA (554 182 [86.7%] males; mean [SD] age, 61.9 [11.7] years) and 16 109 composite AS outcomes that occurred over 6 223 150 person-years. The AS incidence rate was 3.97 (95% CI, 3.81-4.13) per 1000 person-years in patients with RA and 2.45 (95% CI, 2.41-2.49) per 1000 person-years in the control patients (absolute difference, 1.52 per 1000 person-years). Rheumatoid arthritis was associated with an increased risk of composite AS (adjusted hazard ratio [AHR], 1.48; 95% CI, 1.41-1.55), aortic valve intervention (AHR, 1.34; 95% CI, 1.22-1.48), and AS-related death (AHR, 1.26; 95% CI, 1.04-1.54). Conclusions and Relevance: In this cohort study, RA was associated with a higher risk of developing AS and the subsequent risks of undergoing aortic valve intervention and suffering from AS-related death. Future studies are needed to confirm whether valvular heart disease, specifically AS, may be an overlooked cardiovascular disease complication in RA.

The First 4 Years of Postmarketing Safety Surveillance Related to the MitraClip Device: A United States Food and Drug Administration MAUDE Experience.

OBJECTIVE: The MitraClip (Abbott) is a commercially available device to perform percutaneous transcatheter mitral valve repair (TMVR) for patients with symptomatic mitral regurgitation (MR). Recent data support its role in appropriately selected patients with functional MR, and its use is poised to increase. However, limited safety data in "real-world" practice are available after market introduction. METHODS: We queried all available adverse event reports from the publicly available Manufacturer and User Facility Device Experience (MAUDE) database including "injuries" and "deaths" from October 2013 (date of Food and Drug Administration [FDA] premarket approval) to September 2017 using the following search limits: brand name ("MitraClip") and product code ("NKM," a unique FDA designation linked to MitraClip). RESULTS: During the first 4 years after FDA approval, MAUDE received 200 death reports and 1666 injury reports containing 2974 unique adverse events. Of all death reports, 21% described deaths occurring >1 year post MitraClip and 30% included limited details. The top three known causes of death included complications requiring rescue high-risk surgery, clip detachment or unsuccessful clip placement, and damage to the valvular apparatus. Similar non-fatal events were reported. Additional procedures or surgical intervention were required in 227 injury events (8%). CONCLUSIONS: While injuries reported to the FDA have steadily increased with more widespread use of TMVR, device- or procedure-related death reports have accrued more slowly, corroborating a potential institutional or operator learning curve with this device. However, in light of incomplete and poor data quality, higher-fidelity systems of postmarketing safety surveillance are needed in the evaluation of emerging devices.

Predictive Value of Dobutamine Stress Perfusion Echocardiography in Contemporary End-Stage Liver Disease.

BACKGROUND: The assessment of cardiac risk in contemporary liver transplantation (LT) has required more sensitive testing for the detection of occult coronary artery disease as well as microvascular and functional cardiac abnormalities. Because dobutamine stress perfusion echocardiography provides an assessment of both regional systolic and diastolic function as well as microvascular perfusion (MVP), we sought to examine its incremental value in this setting. METHODS AND RESULTS: We evaluated the predictive value of dobutamine stress perfusion echocardiography in 296 adult patients with end-stage liver disease and preserved systolic function who underwent LT between 2008 and 2014. The primary outcome was cardiovascular death, nonfatal myocardial infarction, and/or sustained ventricular arrhythmias following LT. The main causes of liver failure were hepatitis C (25%) and nonalcoholic fatty liver disease (13%). Abnormal MVP during stress was observed in 18 patients (6%), whereas diastolic dysfunction was present in 109 patients (94 grade 1, 15 grade 2). Half of the patients (7 of 14) referred for angiography with abnormal MVP had significant epicardial disease by angiography, and these patients were revascularized prior to LT. Despite these interventions, the primary outcome still occurred in 9 patients (3%). Patients with abnormal MVP during dobutamine stress perfusion echocardiography had a 7-fold higher risk of a cardiovascular event following LT. Cox proportional hazards modeling examining clinical variables, left ventricular ejection fraction, diastolic function, and stress-induced wall motion abnormalities or MVP defects demonstrated that abnormal MVP was the only independent predictor of the primary outcome (P=0.004; hazard ratio 7.7). CONCLUSIONS: Stress MVP assessments are highly predictive of cardiovascular outcome in current LT candidates.