Unplanned Hospital Readmissions After Transcatheter Aortic Valve Replacement in the Era of New-Generation Devices.

OBJECTIVES: Unplanned hospital readmissions after transcatheter aortic valve replacement (TAVR) are frequent and have been associated with a poor prognosis. We sought to determine the trends in the incidence and causes of unplanned hospital readmission after TAVR in patients receiving new-generation devices (NGDs) vs early-generation devices (EGDs). METHODS: The study population consisted of 1802 consecutive TAVR recipients (863 EGDs and 939 NGDs). Early and late readmissions were defined as those occurring ≤30 days and >30 days to 1-year post TAVR, respectively. RESULTS: A total of 986 unplanned hospital readmissions (cardiac cause, 38.4%; non-cardiac cause, 61.6%) were recorded at a median time of 110 days (interquartile range [IQR], 37-217) post TAVR. The rates of early (12.3% vs 9.4%; P=.046) and late (39.1% vs 31.6%; P<.01) readmission were lower in the NGD population. In the NGD group, major/life-threatening periprocedural bleeding (hazard ratio [HR], 2.40, 95% confidence interval [CI], 1.06-5.42; P=.04) and estimated glomerular filtration rate (eGFR) <60 mL/min at hospital discharge (HR, 1.80; 95% CI, 1.15-2.83; P=.01) were associated with an increased risk of early readmission post TAVR. Chronic obstructive pulmonary disease (HR, 1.42; 95% CI, 1.07-1.88; P=.02), eGFR <60 mL/min (HR, 1.43; 95% CI, 1.11-1.84; P<.01), and combining antiplatelet and anticoagulation therapy (HR, 1.37; 95% CI, 1.01-1.85; P=.04) determined an increased risk of late readmission. CONCLUSIONS: TAVR recipients receiving NGDs exhibited a significant but modest reduction in unplanned hospital readmissions, with about one-third of patients still requiring rehospitalization at 1-year follow-up in the contemporary TAVR era. Non-cardiac comorbidities, periprocedural bleeding events, and intensive antithrombotic therapy determined an increased risk.

Early clinical and haemodynamic matched comparison of balloon-expandable valves.

OBJECTIVES: The balloon-expandable Sapien-3 valve demonstrated superior results in terms of residual aortic regurgitation when compared with self-expandable devices. We aimed to compare for the first-time early outcomes of Sapien-3 transcatheter heart valve (THV) with the balloon-expandable Myval device. METHODS: Consecutive real-world patients from nine European institutions with symptomatic severe aortic stenosis treated either with Sapien-3 or Myval THV devices after June 2018 were compared. Early clinical outcomes were prospectively gathered and blinded analysis of 30-day echocardiography was conducted. Matching for the following variables was performed: age, body surface area, Society of Thoracic Surgeons risk score, left ventricular function, mean gradient, transfemoral approach, aortic valvular calcium, aortic annulus mean diameter, area and eccentricity index. RESULTS: A total of 416 patients treated either with the Sapien-3 (n=286, 68.7%) or with Myval THV (n=130, 31.3%) were included and 103 pairs compared after matching. Baseline characteristics were similar. Procedural success rate (Sapien-3: 94.2%; Myval: 93.2%, p=0.219), 30-day mortality (Sapien-3: 2.9%; Myval: 0.97%, p=0.625), clinical efficacy (12.6 vs 4.9%, p=0.057) and early safety (12.6 vs 4.9%, p=0.096) were comparable. There was a lower need for new permanent pacemaker (15.5 vs 5.8% p=0.020) with Myval. No significant differences were found in terms of ≥moderate aortic regurgitation (1% for Sapien-3, 0% for Myval, p=0.314), but mean gradients were higher following Sapien-3 than after Myval (p<0.001). CONCLUSIONS: The new Myval balloon-expandable THV was favourable in terms of safety, with low rate of permanent pacemaker and with favourable residual gradients and paravalvular leak rate according to blinded echocardiographic analysis.

The SADDEN DEATH Study: Results from a Pilot Study in Non-ICU COVID-19 Spanish Patients.

Introduction: The worldwide pandemic, coronavirus disease 2019 (COVID-19) is a novel infection with serious clinical manifestations, including death. Our aim is to describe the first non-ICU Spanish deceased series with COVID-19, comparing specifically between unexpected and expected deaths. Methods: In this single-centre study, all deceased inpatients with laboratory-confirmed COVID-19 who had died from March 4 to April 16, 2020 were consecutively included. Demographic, clinical, treatment, and laboratory data, were analyzed and compared between groups. Factors associated with unexpected death were identified by multivariable logistic regression methods. Results: In total, 324 deceased patients were included. Median age was 82 years (IQR 76-87); 55.9% males. The most common cardiovascular risk factors were hypertension (78.4%), hyperlipidemia (57.7%), and diabetes (34.3%). Other common comorbidities were chronic kidney disease (40.1%), chronic pulmonary disease (30.3%), active cancer (13%), and immunosuppression (13%). The Confusion, BUN, Respiratory Rate, Systolic BP and age ≥65 (CURB-65) score at admission was >2 in 40.7% of patients. During hospitalization, 77.8% of patients received antivirals, 43.3% systemic corticosteroids, and 22.2% full anticoagulation. The rate of bacterial co-infection was 5.5%, and 105 (32.4%) patients had an increased level of troponin I. The median time from initiation of therapy to death was 5 days (IQR 3.0-8.0). In 45 patients (13.9%), the death was exclusively attributed to COVID-19, and in 254 patients (78.4%), both COVID-19 and the clinical status before admission contributed to death. Progressive respiratory failure was the most frequent cause of death (92.0%). Twenty-five patients (7.7%) had an unexpected death. Factors independently associated with unexpected death were male sex, chronic kidney disease, insulin-treated diabetes, and functional independence. Conclusions: This case series provides in-depth characterization of hospitalized non-ICU COVID-19 patients who died in Madrid. Male sex, insulin-treated diabetes, chronic kidney disease, and independency for activities of daily living are predictors of unexpected death.