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Among patients with asymptomatic severe aortic stenosis, early TAVR was superior to clinical surveillance in reducing the incidence of death, stroke, or unplanned hospitalization for cardiovascular causes.

A previous analysis in this trial showed that among patients with severe, symptomatic aortic stenosis who were at low surgical risk, the rate of the composite end point of death, stroke, or rehospitalization at 1 year was significantly lower with transcatheter aortic-valve replacement (TAVR) than with surgical aortic-valve replacement. Longer-term outcomes are unknown. We randomly assigned patients with severe, symptomatic aortic stenosis and low surgical risk to undergo either TAVR or surgery. The first primary end point was a composite of death, stroke, or rehospitalization related to the valve, the procedure, or heart failure. The second primary end point was a hierarchical composite that included death, disabling stroke, nondisabling stroke, and the number of rehospitalization days, analyzed with the use of a win ratio analysis. Clinical, echocardiographic, and health-status outcomes were assessed through 5 years. A total of 1000 patients underwent randomization: 503 patients were assigned to undergo TAVR, and 497 to undergo surgery. A component of the first primary end point occurred in 111 of 496 patients in the TAVR group and in 117 of 454 patients in the surgery group (Kaplan-Meier estimates, 22.8% in the TAVR group and 27.2% in the surgery group; difference, -4.3 percentage points; 95% confidence interval [CI], -9.9 to 1.3; P = 0.07). The win ratio for the second primary end point was 1.17 (95% CI, 0.90 to 1.51; P = 0.25). The Kaplan-Meier estimates for the components of the first primary end point were as follows: death, 10.0% in the TAVR group and 8.2% in the surgery group; stroke, 5.8% and 6.4%, respectively; and rehospitalization, 13.7% and 17.4%. The hemodynamic performance of the valve, assessed according to the mean (±SD) valve gradient, was 12.8±6.5 mm Hg in the TAVR group and 11.7±5.6 mm Hg in the surgery group. Bioprosthetic-valve failure occurred in 3.3% of the patients in the TAVR group and in 3.8% of those in the surgery group. Among low-risk patients with severe, symptomatic aortic stenosis who underwent TAVR or surgery, there was no significant between-group difference in the two primary composite outcomes. (Funded by Edwards Lifesciences; PARTNER 3 ClinicalTrials.gov number, NCT02675114.).

In this large trial, denervation of the kidneys with use of a radiofrequency ablation catheter in the renal arteries had no significant effect on blood pressure in patients with resistant hypertension. This contradicts results of smaller trials that did not include a sham control. Because of the aging of the population and rising rates of obesity, hypertension is increasing in prevalence worldwide. 1 Approximately 10% of patients with diagnosed hypertension have resistant hypertension, defined as a systolic blood pressure of 140 mm Hg or higher despite adherence to at least three maximally tolerated doses of antihypertensive medications from complementary classes, including a diuretic at an appropriate dose. 1 – 4 Patients with resistant hypertension who are receiving appropriate medical therapy have high rates of cardiovascular complications, with few treatment options. The sympathetic nervous system — in particular, sympathetic cross-talk between the kidneys and the brain — appears . . .

Transcatheter aortic valve replacement (TAVR) is an effective treatment for severe symptomatic aortic stenosis (AS) in patients who are inoperable or at high risk for surgery. However, the intermediate- to long-term mortality is high, emphasizing the importance of patient selection. We, therefore, sought to evaluate the prognostic value of frailty in older recipients of TAVR, hypothesizing that frail patients would experience a higher mortality rate and a higher likelihood of poor outcome 1 year after TAVR. This substudy of the Placement of Aortic Transcatheter Valves trial was conducted at 3 high-enrolling sites where frailty was assessed systematically before TAVR. In total, 244 patients received TAVR at the participating sites. Frailty was assessed using a composite of 4 markers (serum albumin, dominant handgrip strength, gait speed, and Katz activity of daily living survey), which were combined into a frailty score. The cohort was dichotomized at median frailty score. Outcomes measures were the time to death from any cause for >1 year of follow-up and poor outcome at 1 year. Poor outcome was defined as (1) death, (2) Kansas City Cardiomyopathy Questionnaire overall summary (KCCQ-OS) score <60, or (3) decrease of ≥10 points in the KCCQ-OS score from baseline to 1 year. At 1 year, the Kaplan-Meier–estimated all-cause mortality rate was 32.7% in the frail group and 15.9% in the nonfrail group (log-rank p = 0.004). At 1 year, poor outcome occurred in 50.0% of the frail group and 31.5% of the nonfrail group (p = 0.02). In conclusion, frailty was associated with increased mortality and a higher rate of poor outcome 1 year after TAVR.

Subclinical leaflet thrombosis of bioprosthetic aortic valves after transcatheter valve replacement (TAVR) and surgical aortic valve replacement (SAVR) has been found with CT imaging. The objective of this study was to report the prevalence of subclinical leaflet thrombosis in surgical and transcatheter aortic valves and the effect of novel oral anticoagulants (NOACs) on the subclinical leaflet thrombosis and subsequent valve haemodynamics and clinical outcomes on the basis of two registries of patients who had CT imaging done after TAVR or SAVR. Patients enrolled between Dec 22, 2014, and Jan 18, 2017, in the RESOLVE registry, and between June 2, 2014, and Sept 28, 2016, in the SAVORY registry, had CT imaging done with a dedicated four-dimensional volume-rendered imaging protocol at varying intervals after TAVR and SAVR. We defined subclinical leaflet thrombosis as the presence of reduced leaflet motion, along with corresponding hypoattenuating lesions shown with CT. We collected data for baseline demographics, antithrombotic therapy, and clinical outcomes. We analysed all CT scans, echocardiograms, and neurological events in a masked fashion. Of the 931 patients who had CT imaging done (657 [71%] in the RESOLVE registry and 274 [29%] in the SAVORY registry), 890 [96%] had interpretable CT scans (626 [70%] in the RESOLVE registry and 264 [30%] in the SAVORY registry). 106 (12%) of 890 patients had subclinical leaflet thrombosis, including five (4%) of 138 with thrombosis of surgical valves versus 101 (13%) of 752 with thrombosis of transcatheter valves (p=0·001). The median time from aortic valve replacement to CT for the entire cohort was 83 days (IQR 33–281). Subclinical leaflet thrombosis was less frequent among patients receiving anticoagulants (eight [4%] of 224) than among those receiving dual antiplatelet therapy (31 [15%] of 208; p<0·0001); NOACs were equally as effective as warfarin (three [3%] of 107 vs five [4%] of 117; p=0·72). Subclinical leaflet thrombosis resolved in 36 (100%) of 36 patients (warfarin 24 [67%]; NOACs 12 [33%]) receiving anticoagulants, whereas it persisted in 20 (91%) of 22 patients not receiving anticoagulants (p<0·0001). A greater proportion of patients with subclinical leaflet thrombosis had aortic valve gradients of more than 20 mm Hg and increases in aortic valve gradients of more than 10 mm Hg (12 [14%] of 88) than did those with normal leaflet motion (seven [1%] of 632; p<0·0001). Although stroke rates were not different between those with (4·12 strokes per 100 person-years) or without (1·92 strokes per 100 person-years) reduced leaflet motion (p=0·10), subclinical leaflet thrombosis was associated with increased rates of transient ischaemic attacks (TIAs; 4·18 TIAs per 100 person-years vs 0·60 TIAs per 100 person-years; p=0·0005) and all strokes or TIAs (7·85 vs 2·36 per 100 person-years; p=0·001). Subclinical leaflet thrombosis occurred frequently in bioprosthetic aortic valves, more commonly in transcatheter than in surgical valves. Anticoagulation (both NOACs and warfarin), but not dual antiplatelet therapy, was effective in prevention or treatment of subclinical leaflet thrombosis. Subclinical leaflet thrombosis was associated with increased rates of TIAs and strokes or TIAs. Despite excellent outcomes after TAVR with the new-generation valves, prevention and treatment of subclinical leaflet thrombosis might offer a potential opportunity for further improvement in valve haemodynamics and clinical outcomes. RESOLVE (Cedars-Sinai Heart Institute) and SAVORY (Rigshospitalet).

The coronavirus disease 2019 (COVID-19) can result in a hyperinflammatory state, leading to acute respiratory distress syndrome (ARDS), myocardial injury, and thrombotic complications, among other sequelae. Statins, which are known to have anti-inflammatory and antithrombotic properties, have been studied in the setting of other viral infections, but their benefit has not been assessed in COVID-19. This is a retrospective analysis of patients admitted with COVID-19 from February 1 st through May 12 th , 2020 with study period ending on June 11 th , 2020. Antecedent statin use was assessed using medication information available in the electronic medical record. We constructed a multivariable logistic regression model to predict the propensity of receiving statins, adjusting for baseline sociodemographic and clinical characteristics, and outpatient medications. The primary endpoint includes in-hospital mortality within 30 days. A total of 2626 patients were admitted during the study period, of whom 951 (36.2%) were antecedent statin users. Among 1296 patients (648 statin users, 648 non-statin users) identified with 1:1 propensity-score matching, statin use is significantly associated with lower odds of the primary endpoint in the propensity-matched cohort (OR 0.47, 95% CI 0.36–0.62, p  < 0.001). We conclude that antecedent statin use in patients hospitalized with COVID-19 is associated with lower inpatient mortality. Statins, which have anti-inflammatory and antithrombotic properties, could have effects in COVID-19 patients. Here, the authors find in a retrospective analysis of patients hospitalized with COVID-19 that antecedent statin use is associated with lower inpatient mortality.

This study provides 2-year data from the PARTNER trial, in which patients with aortic stenosis received transcatheter aortic-valve replacement (TAVR) or surgical replacement. Overall mortality was similar, but paravalvular leak increased mortality in the TAVR group. Aortic stenosis is associated with high mortality after the appearance of cardiac symptoms. 1 Nevertheless, many patients do not undergo surgical aortic-valve replacement owing to real or perceived increased risks associated with surgery. 2 – 5 Transcatheter aortic-valve replacement (TAVR) has emerged as an alternative therapy in high-risk patients with aortic stenosis. 6 – 10 Observational registries from various countries have reported 1-month and 1-year outcomes after TAVR, 11 – 14 but there are limited long-term follow-up data. 15 The Placement of Aortic Transcatheter Valves (PARTNER) trial was a randomized trial comparing TAVR with standard-of-care therapies in high-risk patients with aortic stenosis. One-year mortality outcomes from PARTNER showed . . .

The relative safety of drug-eluting stents and bare-metal stents, especially with respect to stent thrombosis, continues to be debated. In view of the overall low frequency of stent thrombosis, large sample sizes are needed to accurately estimate treatment differences between stents. We compared the risk of thrombosis between bare-metal and drug-eluting stents. For this network meta-analysis, randomised controlled trials comparing different drug-eluting stents or drug-eluting with bare-metal stents currently approved in the USA were identified through Medline, Embase, Cochrane databases, and proceedings of international meetings. Information about study design, inclusion and exclusion criteria, sample characteristics, and clinical outcomes was extracted. 49 trials including 50 844 patients randomly assigned to treatment groups were analysed. 1-year definite stent thrombosis was significantly lower with cobalt-chromium everolimus eluting stents (CoCr-EES) than with bare-metal stents (odds ratio [OR] 0·23, 95% CI 0·13–0·41). The significant difference in stent thrombosis between CoCr-EES and bare-metal stents was evident as early as 30 days (OR 0·21, 95% CI 0·11–0·42) and was also significant between 31 days and 1 year (OR 0·27, 95% CI 0·08–0·74). CoCr-EES were also associated with significantly lower rates of 1-year definite stent thrombosis compared with paclitaxel-eluting stents (OR 0·28, 95% CI 0·16–0·48), permanent polymer-based sirolimus-eluting stents (OR 0·41, 95% CI 0·24–0·70), phosphorylcholine-based zotarolimus-eluting stents (OR 0·21, 95% CI 0·10–0·44), and Resolute zotarolimus-eluting stents (OR 0·14, 95% CI 0·03–0·47). At 2-year follow-up, CoCr-EES were still associated with significantly lower rates of definite stent thrombosis than were bare-metal (OR 0·35, 95% CI 0·17–0·69) and paclitaxel-eluting stents (OR 0·34, 95% CI 0·19–0·62). No other drug-eluting stent had lower definite thrombosis rates compared with bare-metal stents at 2-year follow-up. In randomised studies completed to date, CoCr-EES has the lowest rate of stent thrombosis within 2 years of implantation. The finding that CoCr-EES also reduced stent thrombosis compared with bare-metal stents, if confirmed in future randomised trials, represents a paradigm shift. The Cardiovascular Research Foundation.

This study examines use of an expandable bovine pericardial prosthetic valve inserted with a catheter system for valvular aortic stenosis. Outcomes were noninferior to those of surgical aortic-valve replacement, but the risk of stroke, aortic regurgitation, and vascular complications was substantial. After the appearance of symptoms, aortic stenosis is associated with a high rate of death if left untreated. 1 – 10 Although surgical aortic-valve replacement improves symptoms and survival, 11 – 15 observational studies have identified various subgroups of patients (i.e., those with an advanced age and those with poor left ventricular function or other coexisting disorders) who are at increased risk for operative complications or death. 16 – 21 In such patients, a less invasive treatment may be a desirable alternative. Transcatheter aortic-valve replacement treats aortic stenosis by displacing and functionally replacing the native valve with a bioprosthetic valve delivered on a catheter through the . . .

Transcatheter aortic valve implantation (TAVI) has revolutionized the treatment of symptomatic severe aortic valve stenosis. Current guidelines recommend TAVI in patients at increased operative risk of death. Advanced imaging planning, new transcatheter valve platforms, procedure streamlining and growing operator experience have improved procedural safety and bioprosthetic valve performance. As a result, TAVI has been explored for other indications. Two randomized trials published in 2019 to assess TAVI in patients with symptomatic severe aortic stenosis at low operative risk have set the stage for a new wave of indications. In younger and low-risk patients, TAVI had an early safety benefit over surgical aortic valve replacement and was associated with faster discharge from hospital and recovery and fewer rehospitalizations. In patients with symptomatic severe aortic stenosis, TAVI has now been explored across the entire spectrum of operative risk, from inoperable to low-risk populations, in properly designed, randomized clinical trials, although data on the long-term durability of these valves are lacking. The use of TAVI in severe bicuspid aortic valve stenosis, asymptomatic severe aortic stenosis, moderate aortic stenosis in combination with heart failure with reduced ejection fraction, and isolated pure aortic regurgitation is now under investigation in clinical trials. In this Review, we provide our perspective on these evolving indications for TAVI, discuss relevant available data from clinical trials, and highlight procedural implications and caveats of new and future indications.This Review discusses the evolving indications of transcatheter aortic valve implantation (TAVI), including the latest clinical trials in young and low-risk patients with symptomatic severe aortic stenosis and ongoing studies exploring TAVI for other indications, including severe bicuspid aortic valve stenosis and pure native aortic regurgitation, highlighting procedural implications and caveats of new and future indications.