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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 . . .

Based on the early results of the Placement of Aortic Transcatheter Valves (PARTNER) trial, transcatheter aortic valve replacement (TAVR) is an accepted treatment for patients with severe aortic stenosis who are not suitable for surgery. However, little information is available about the late clinical outcomes in such patients. We did this randomised controlled trial at 21 experienced valve centres in Canada, Germany, and the USA. We enrolled patients with severe symptomatic inoperable aortic stenosis and randomly assigned (1:1) them to transfemoral TAVR or to standard treatment, which often included balloon aortic valvuloplasty. Patients and their treating physicians were not masked to treatment allocation. The randomisation was done centrally, and sites learned of the assignment only after a patient had been screened, consented, and entered into the database. The primary outcome of the trial was all-cause mortality at 1 year in the intention-to-treat population, here we present the prespecified findings after 5 years. This study is registered with ClinicalTrials.gov, number NCT00530894. We screened 3015 patients, of whom 358 were enrolled (mean age 83 years, Society of Thoracic Surgeons Predicted Risk of Mortality 11·7%, 54% female). 179 were assigned to TAVR treatment and 179 were assigned to standard treatment. 20 patients crossed over from the standard treatment group and ten withdrew from study, leaving only six patients at 5 years, of whom five had aortic valve replacement treatment outside of the study. The risk of all-cause mortality at 5 years was 71·8% in the TAVR group versus 93·6% in the standard treatment group (hazard ratio 0·50, 95% CI 0·39–0·65; p<0·0001). At 5 years, 42 (86%) of 49 survivors in the TAVR group had New York Heart Association class 1 or 2 symptoms compared with three (60%) of five in the standard treatment group. Echocardiography after TAVR showed durable haemodynamic benefit (aortic valve area 1·52 cm2 at 5 years, mean gradient 10·6 mm Hg at 5 years), with no evidence of structural valve deterioration. TAVR is more beneficial than standard treatment for treatment of inoperable aortic stenosis. TAVR should be strongly considered for patients who are not surgical candidates for aortic valve replacement to improve their survival and functional status. Appropriate selection of patients will help to maximise the benefit of TAVR and reduce mortality from severe comorbidities. Edwards Lifesciences.

Patients with aortic stenosis underwent transfemoral transcatheter implantation of a balloon-expandable bovine pericardial aortic valve. One-year mortality was lower with the balloon-expandable valve than with standard therapy, but the risk of stroke was higher. Aortic stenosis is an insidious disease with a long latency period 1 followed by rapid progression after the appearance of symptoms, 2 – 5 resulting in a high rate of death (approximately 50% in the first 2 years after symptoms appear) among untreated patients. 1 , 6 – 8 Surgical replacement of the aortic valve reduces symptoms and improves survival in patients with aortic stenosis, 9 – 11 and in the absence of serious coexisting conditions, the procedure is associated with low operative mortality. 12 , 13 However, in clinical practice, at least 30% of patients with severe symptomatic aortic stenosis do not undergo surgery for replacement of the aortic . . .

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 . . .

This article provides 2-year data on patients with inoperable aortic stenosis randomly assigned to receive standard therapy or transcatheter aortic-valve replacement (TAVR). Death rates at 2 years were higher with standard therapy, but the rate of stroke was higher with TAVR. Symptomatic aortic stenosis, if left untreated, is characterized by a high risk of death. 1 – 6 In the randomized Placement of Aortic Transcatheter Valves (PARTNER) trial, transcatheter aortic-valve replacement (TAVR), as compared with standard therapy, in patients who were not considered to be suitable candidates for surgery, decreased the rate of death at 1 year, reduced cardiac symptoms, and improved the hemodynamic performance of the valve. 2 Longer-term outcomes are essential to guide clinical practice decisions in this elderly patient population, in which many of the patients have multiple coexisting conditions. Moreover, there is a paucity of long-term data on the performance . . .

The Placement of Aortic Transcatheter Valves (PARTNER) trial showed that mortality at 1 year, 2 years, and 3 years is much the same with transcatheter aortic valve replacement (TAVR) or surgical aortic valve replacement (SAVR) for high-risk patients with aortic stenosis. We report here the 5-year outcomes. We did this randomised controlled trial at 25 hospitals, in Canada (two), Germany (one), and the USA (23). We used a computer-generated randomisation sequence to randomly assign high-risk patients with severe aortic stenosis to either SAVR or TAVR with a balloon-expandable bovine pericardial tissue valve by either a transfemoral or transapical approach. Patients and their treating physicians were not masked to treatment allocation. The primary outcome of the trial was all-cause mortality in the intention-to-treat population at 1 year, we present here predefined outcomes at 5 years. The study is registered with ClinicalTrials.gov, number NCT00530894. We screened 3105 patients, of whom 699 were enrolled (348 assigned to TAVR, 351 assigned to SAVR). Overall mean Society of Thoracic Surgeons Predicted Risk of Mortality score was 11·7%. At 5 years, risk of death was 67·8% in the TAVR group compared with 62·4% in the SAVR group (hazard ratio 1·04, 95% CI 0·86–1·24; p=0·76). We recorded no structural valve deterioration requiring surgical valve replacement in either group. Moderate or severe aortic regurgitation occurred in 40 (14%) of 280 patients in the TAVR group and two (1%) of 228 in the SAVR group (p<0·0001), and was associated with increased 5-year risk of mortality in the TAVR group (72·4% for moderate or severe aortic regurgitation vs 56·6% for those with mild aortic regurgitation or less; p=0·003). Our findings show that TAVR as an alternative to surgery for patients with high surgical risk results in similar clinical outcomes. Edwards Lifesciences.