BACKGROUND Coronavirus disease-2019 (COVID-19) is caused by severe acute respiratory-syndrome coronavirus-2 that interfaces with the renin-angiotensin-aldosterone system (RAAS) through angiotensin-converting enzyme 2. This interaction has been proposed as a potential risk factor in patients treated with RAAS inhibitors. OBJECTIVES This study analyzed whether RAAS inhibitors modify the risk for COVID-19. METHODS The RASTAVI (Renin-Angiotensin System Blockade Benefits in Clinical Evolution and Ventricular Remodeling After Transcatheter Aortic Valve Implantation) trial is an ongoing randomized clinical trial randomly allocating subjects to ramipril or control groups after successful transcatheter aortic valve replacement at 14 centers in Spain. A non-prespecified interim analysis was performed to evaluate ramipril's impact on COVID-19 risk in this vulnerable population. RESULTS As of April 1, 2020, 102 patients (50 in the ramipril group and 52 in the control group) were included in the trial. Mean age was 82.3 AE 6.1 years, 56.9% of the participants were male. Median time of ramipril treatment was 6 months (interquartile range: 2.9 to 11.4 months). Eleven patients (10.8%) have been diagnosed with COVID-19 (6 in control group and 5 receiving ramipril; hazard ratio: 1.150; 95% confidence interval: 0.351 to 3.768). The risk of COVID-19 was increased in older patients (p ¼ 0.019) and those with atrial fibrillation (p ¼ 0.066), lower hematocrit (p ¼ 0.084), and more comorbidities according to Society of Thoracic Surgeons score (p ¼ 0.065). Admission and oxygen supply was required in 4.9% of patients (2 in the ramipril group and 3 in the control group), and 4 of them died (2 in each randomized group). A higher body mass index was the only factor increasing the mortality rate (p ¼ 0.039). CONCLUSIONS In a high-risk population of older patients with cardiovascular disease, randomization to ramipril had no impact on the incidence or severity of COVID-19. This analysis supports the maintenance of RAAS inhibitor treatment during the COVID-19 crisis. (Renin-Angiotensin System Blockade Benefits in Clinical Evolution and Ventricular Remodeling After Transcatheter Aortic Valve Implantation [RASTAVI]; NCT03201185)

Introduction and objectives The COVID-19 outbreak has had an unclear impact on the treatment and outcomes of patients with ST-segment elevation myocardial infarction (STEMI). The aim of this study was to assess changes in STEMI management during the COVID-19 outbreak. Methods Using a multicenter, nationwide, retrospective, observational registry of consecutive patients who were managed in 75 specific STEMI care centers in Spain, we compared patient and procedural characteristics and in-hospital outcomes in 2 different cohorts with 30-day follow-up according to whether the patients had been treated before or after COVID-19. Results Suspected STEMI patients treated in STEMI networks decreased by 27.6% and patients with confirmed STEMI fell from 1305 to 1009 (22.7%). There were no differences in reperfusion strategy (> 94% treated with primary percutaneous coronary intervention in both cohorts). Patients treated with primary percutaneous coronary intervention during the COVID-19 outbreak had a longer ischemic time (233 [150-375] vs 200 [140-332] minutes, P < .001) but showed no differences in the time from first medical contact to reperfusion. In-hospital mortality was higher during COVID-19 (7.5% vs 5.1%; unadjusted OR, 1.50; 95%CI, 1.07-2.11; P < .001); this association remained after adjustment for confounders (risk-adjusted OR, 1.88; 95%CI, 1.12-3.14; P = .017). In the 2020 cohort, there was a 6.3% incidence of confirmed SARS-CoV-2 infection during hospitalization. Conclusions The number of STEMI patients treated during the current COVID-19 outbreak fell vs the previous year and there was an increase in the median time from symptom onset to reperfusion and a significant 2-fold increase in the rate of in-hospital mortality. No changes in reperfusion strategy were detected, with primary percutaneous coronary intervention performed for the vast majority of patients. The co-existence of STEMI and SARS-CoV-2 infection was relatively infrequent.

Background: Currently, 2 third-generation transcatheter valves, 29-mm Sapien-3 and 34-mm Evolut-R (ER), are indicated for large sized aortic annuli. We analyzed short and 1-year performance of these valves in patients with large (area ≥575 mm 2 or perimeter ≥85 mm) and extra-large (≥683 mm 2 or ≥94.2 mm) aortic annuli undergoing transcatheter aortic valve replacement. Methods: A total of 833 patients across 12 centers with symptomatic aortic stenosis and large aortic annuli underwent transcatheter aortic valve replacement with 29-mm Sapien-3 (n=640) or 34-mm ER (n=193). Clinical, anatomic, and procedural characteristics were collected, and Valve Academic Research Consortium-2 outcomes were reported. Results: Median aortic annulus area and perimeter were 617 mm 2 (591–657) and 89.1 mm (87.0–92.1), respectively (704 mm 2 [689–743] and 96.0 mm [94.5–97.9] in the subgroup of 124 patients with extra-large annuli). Overall device success was 94.3% (Sapien-3, 95.8% and ER, 89.3%; P =0.001), with a higher rate of significant paravalvular leak ( P =0.004), second valve implantation ( P =0.013), and valve embolization ( P =0.009) in the ER group. Thirty-day and 1-year mortality was 2.4% and 9.2%, respectively, without differences between groups. Valve hemodynamics were excellent (mean gradient, 8.8±3.6 mm Hg; 3.3% rate of moderate-severe paravalvular leak) in the extra-large annulus, without differences compared with the large annulus group. Conclusions: In patients with large and extra-large aortic annuli, transcatheter aortic valve replacement using 29-mm Sapien-3 and 34-mm ER is safe and feasible. Observed differences in clinical outcomes and hemodynamic performance may guide valve choice in this cohort of patients undergoing transcatheter aortic valve replacement.

Background: Scarce data exist on coronary events following transcatheter aortic valve replacement (TAVR), and no study has determined the factors associated with poorer outcomes in this setting. This study sought to determine the clinical characteristics, outcomes, and prognostic factors of acute coronary syndrome (ACS) events following TAVR. Methods: Multicenter cohort study including a total of 270 patients presenting an ACS after a median time of 12 (interquartile range, 5–17) months post-TAVR. Post-ACS death, myocardial infarction, stroke, and overall major adverse cardiovascular or cerebrovascular events were recorded. Results: The ACS clinical presentation consisted of non–ST-segment–elevation myocardial infarction (STEMI) type 2 (31.9%), non–STEMI type 1 (31.5%), unstable angina (28.5%), and STEMI (8.1%). An invasive strategy was used in 163 patients (60.4%), and a percutaneous coronary intervention was performed in 97 patients (35.9%). Coronary access issues were observed in 2.5% and 2.1% of coronary angiography and percutaneous coronary intervention procedures, respectively. The in-hospital mortality rate was 10.0%, and at a median follow-up of 17 (interquartile range, 5–32) months, the rates of death, stroke, myocardial infarction, and major adverse cardiovascular or cerebrovascular events were 43.0%, 4.1%, 15.2%, and 52.6%, respectively. By multivariable analysis, revascularization at ACS time was associated with a reduction of the risk of all-cause death (hazard ratio, 0.54 [95% CI, 0.36–0.81] P =0.003), whereas STEMI increased the risk of all-cause death (hazard ratio, 2.06 [95% CI, 1.05–4.03] P =0.036) and major adverse cardiovascular or cerebrovascular events (hazard ratio, 1.97 [95% CI, 1.08–3.57] P =0.026). Conclusions: ACS events in TAVR recipients exhibited specific characteristics (ACS presentation, low use of invasive procedures, coronary access issues) and were associated with a poor prognosis, with a very high in-hospital and late death rate. STEMI and the lack of coronary revascularization determined an increased risk. These results should inform future studies to improve both the prevention and management of ACS post-TAVR.

Background: Transfemoral approach has been commonly used as secondary access in transcatheter aortic valve replacement (TAVR). Scarce data exist on the use and potential clinical benefits of the transradial approach as secondary access during TAVR procedures. The objective of the study is to determine the occurrence of vascular complications (VC) and clinical outcomes according to secondary access (transfemoral versus transradial) in patients undergoing TAVR. Methods: This was a multicenter study including 4949 patients who underwent TAVR (mean age, 81±8 years, mean Society of Thoracic Surgeons score, 4.9 [3.3–7.5]). Transfemoral and transradial approaches were used as secondary access in 4016 (81.1%) and 933 (18.9%) patients, respectively. The 30-day clinical events (vascular and bleeding complications, stroke, acute kidney injury, and mortality) were evaluated and defined according to Valve Academic Research Consortium-2 criteria. Clinical outcomes were analyzed according to the secondary access (transfemoral versus transradial) in the overall population and in a propensity score-matched population involving 2978 transfemoral and 928 transradial patients. Results: Related-access VC occurred in 834 (16.9%) patients (major VC, 5.7%) and were related to the secondary access in 172 (3.5%) patients (major VC, 1.3%). The rate of VC related to the secondary access was higher in the transfemoral group (VC, 4.1% versus 0.9%, P <0.001; major VC, 1.6% versus 0%, P <0.001). In the propensity score-matched population, VC related to the secondary access remained higher in the transfemoral group (4.7% versus 0.9%, P <0.001; major VC, 1.8% versus 0%, P <0.001), which also exhibited a higher rate of major/life-threatening bleeding events (1.0% versus 0%, P <0.001). Significant differences between secondary access groups were observed regarding the rates of 30-day stroke (transfemoral: 3.1%, transradial: 1.6%; P =0.043), acute kidney injury (transfemoral: 9.9%, transradial: 5.7%; P <0.001), and mortality (transfemoral: 4.0%, transradial: 2.4%, P =0.047). Conclusions: The use of transradial approach as secondary access in TAVR procedures was associated with a significant reduction in vascular and bleeding complications and improved 30-day outcomes. Future randomized studies are warranted.

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Background There is a paucity of outcome data on patients who are morbidly obese (MO) undergoing transcatheter aortic valve replacement. We aimed to determine their periprocedural and midterm outcomes and investigate the impact of obesity phenotype. Methods and Results Consecutive patients who are MO (body mass index, ≥40 kg/m 2 , or ≥35 kg/m 2 with obesity‐related comorbidities; n=910) with severe aortic stenosis who underwent transcatheter aortic valve replacement in 18 tertiary hospitals were compared with a nonobese cohort (body mass index, 18.5–29.9 kg/m 2 , n=2264). Propensity‐score matching resulted in 770 pairs. Pre–transcatheter aortic valve replacement computed tomography scans were centrally analyzed to assess adipose tissue distribution; epicardial, abdominal visceral and subcutaneous fat. Major vascular complications were more common (6.6% versus 4.3%; P =0.043) and device success was less frequent (84.4% versus 88.1%; P =0.038) in the MO group. Freedom from all‐cause and cardiovascular mortality were similar at 2 years (79.4 versus 80.6%, P =0.731; and 88.7 versus 87.4%, P =0.699; MO and nonobese, respectively). Multivariable analysis identified baseline glomerular filtration rate and nontransfemoral access as independent predictors of 2‐year mortality in the MO group. An adverse MO phenotype with an abdominal visceral adipose tissue:subcutaneous adipose tissue ratio ≥1 (VAT:SAT) was associated with increased 2‐year all‐cause (hazard ratio [HR], 3.06; 95% CI, 1.20–7.77; P =0.019) and cardiovascular (hazard ratio, 4.11; 95% CI, 1.06–15.90; P =0.041) mortality, and readmissions (HR, 1.81; 95% CI, 1.07–3.07; P =0.027). After multivariable analysis, a (VAT:SAT) ratio ≥1 remained a strong predictor of 2‐year mortality (hazard ratio, 2.78; P =0.035). Conclusions Transcatheter aortic valve replacement in patients who are MO has similar short‐ and midterm outcomes to nonobese patients, despite higher major vascular complications and lower device success. An abdominal VAT:SAT ratio ≥1 identifies an obesity phenotype at higher risk of adverse clinical outcomes.

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