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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.).

The SMall Annuli Randomized To Evolut or SAPIEN (SMART) Trial was designed to compare the performance of the two most widely available commercial transcatheter aortic valve replacement (TAVR) devices in patients with symptomatic severe native aortic stenosis with a small aortic valve annulus undergoing transfemoral TAVR. Patients with small aortic valve annuli are typically female and are often underrepresented in clinical trials. The SMART Trial is an international, prospective, multi-center, randomized controlled, post-market trial. The trial will be conducted in approximately 700 subjects at approximately 90 sites globally. Inclusion criteria include severe aortic stenosis, aortic valve annulus area of ≤430 mm2 based on multi-detector computed tomography, and appropriate anatomy for both the Medtronic Evolut PRO/PRO+ self-expanding and Edwards SAPIEN 3/3 Ultra balloon-expandable devices. The primary clinical outcome composite endpoint is defined as mortality, disabling stroke or heart failure rehospitalization at 12 months. The co-primary valve function composite endpoint is defined as bioprosthetic valve dysfunction at 12 months which includes hemodynamic structural valve dysfunction, defined as a mean gradient ≥20 mmHg, non-structural valve dysfunction, defined as severe prothesis-patient mismatch or ≥moderate aortic regurgitation, thrombosis, endocarditis, and aortic valve re-intervention. Powered secondary endpoints will be assessed hierarchically. The SMART trial will be the largest head-to-head comparative trial of transfemoral TAVR using the two most widely available contemporary TAVR devices in the setting of small aortic annuli and the largest trial to enroll primarily women. URL: www.clinicaltrials.gov, Unique identifier: NCT04722250.

B-type natriuretic peptide (BNP) levels have shown a correlation with outcomes in studies of aortic valve surgery. Results from multicenter trials of BNP in transcatheter aortic valve surgery (TAVR) are lacking. The aim of this study was to investigate the prognostic role of serial measurement of BNP in transfemoral TAVR. A total of 1,097 patients who underwent TAVR via transfemoral access were analyzed by tertile of baseline BNP. Of those, 933 with BNP levels at 30 days were divided into 2 groups on the basis of increases (334 patients) or decreases or no change (599 patients) in BNP compared with baseline. Patients in the low-tertile BNP group had a lower rate of death at 1 year than those in the higher tertile group (15.0% vs 23.0%, p <0.01) which was not significant in multivariate analysis. Over 1 year, BNP decreased from 1,258.13 ± 2,988.33 to 594.37 ± 1,087.30 (p <0.01) in the entire group. Patients in the BNP-rise group had higher rates of death at 1 year (20.3% vs 11.4%, p <0.01) and an overall increase in moderate or severe aortic regurgitation over 1 year (p <0.01). Multivariate predictors of 1-year mortality were moderate or severe aortic regurgitation (hazard ratio 2.04, 95% confidence interval 1.36 to 3.05, p <0.01), increase in BNP at 30 days (hazard ratio 1.82, 95% confidence interval 1.26 to 2.62, p <0.01) and Society of Thoracic Surgeons score (hazard ratio 1.05, 95% confidence interval 1.01 to 1.10, p = 0.03). In conclusion, increase in BNP at 30 days from baseline and moderate or severe aortic regurgitation at 30 days in patients who undergo transfemoral TAVR are independently associated with 1-year mortality. Increase in BNP at 30 days should prompt evaluation for causes of elevated wall stress, including aortic regurgitation.

B-type natriuretic peptide is released from the ventricles of the heart in response to hemodynamic stress, and blood levels of B-type natriuretic peptide may be useful in the diagnosis of heart failure. In this study, a rapid, bedside immunoassay for B-type natriuretic peptide was used to make or exclude the diagnosis of heart failure in patients with acute dyspnea from various causes. The assay was found to have good sensitivity and excellent specificity in the diagnosis of heart failure. Rapid measurement of this peptide is useful in establishing or excluding the diagnosis of congestive heart failure. Currently, there are 5 million Americans with congestive heart failure, with nearly 500,000 new cases every year. 1 The prevalence of symptomatic heart failure in the general European population ranges from 0.4 percent to 2.0 percent. 2 Because of the high total direct costs of care for heart failure, estimated at $10 billion to $38 billion per year, the Health Care Financing Administration (now the Centers for Medicare and Medicaid Services) targeted heart failure as the disease most worthy of cost-effective management. 3 To provide cost-effective treatment for patients with congestive heart failure, rapid and accurate differentiation of congestive heart failure from other . . .

The Centers for Medicare and Medicaid Services has required minimum procedural volumes as a condition of reimbursement for TAVR. CMS is reviewing this policy. In this analysis of data from 2015 through 2017, mortality at 30 days was higher among patients treated at hospitals or by operators with a lower volume of TAVR procedures.

Patients who had undergone successful TAVR were randomly assigned to receive either a rivaroxaban-based antithrombotic regimen or an antiplatelet-based antithrombotic regimen. At 17 months, the primary outcome of death or thromboembolic complications occurred more frequently with rivaroxaban.

Intermediate-risk patients with aortic stenosis were randomly assigned to undergo either transcatheter or surgical aortic-valve replacement. At 5 years, there was no significant difference between the two groups in the incidence of death or disabling stroke. The incidence of aortic regurgitation was higher with transcatheter AVR.

In a trial of TAVR in patients with a small aortic annulus, a self-expanding valve was noninferior to a balloon-expandable valve for clinical outcomes and was superior for bioprosthetic-valve dysfunction through 12 months.

In a randomized trial involving more than 2000 patients, transcatheter aortic-valve replacement was noninferior to surgical replacement in the primary end point of death from any cause or disabling stroke at 2 years. Transcatheter aortic-valve replacement (TAVR) is a new therapy for patients with severe aortic stenosis who are not candidates for surgery 1 , 2 or who are at high risk for complications due to surgery. 3 , 4 The acceptance of the use of TAVR in high-risk patients was based on evidence from clinical trials 5 , 6 that used early-generation TAVR devices; these procedures were associated with considerable procedure-related complications. 7 – 9 Recently, increased operator experience and enhanced transcatheter valve systems have led to a worldwide trend to use TAVR in patients who are at low or intermediate risk. 10 – 12 This trend has been evaluated in small . . .