Transcatheter Versus Surgical Aortic-Valve Replacement in High-Risk Patients

Abstract

Background The use of transcatheter aortic-valve replacement has been shown to reduce mortality among high-risk patients with aortic stenosis who are not candidates for surgical replacement. However, the two procedures have not been compared in a randomized trial involving high-risk patients who are still candidates for surgical replacement. Methods At 25 centers, we randomly assigned 699 high-risk patients with severe aortic stenosis to undergo either transcatheter aortic-valve replacement with a balloon-expandable bovine pericardial valve (either a transfemoral or a transapical approach) or surgical replacement. The primary end point was death from any cause at 1 year. The primary hypothesis was that transcatheter replacement is not inferior to surgical replacement. Results The rates of death from any cause were 3.4% in the transcatheter group and 6.5% in the surgical group at 30 days (P = 0.07) and 24.2% and 26.8%, respectively, at 1 year (P = 0.44), a reduction of 2.6 percentage points in the transcatheter group (upper limit of the 95% confidence interval, 3.0 percentage points; predefined margin, 7.5 percentage points; P = 0.001 for noninferiority). The rates of major stroke were 3.8% in the transcatheter group and 2.1% in the surgical group at 30 days (P = 0.20) and 5.1% and 2.4%, respectively, at 1 year (P = 0.07). At 30 days, major vascular complications were significantly more frequent with transcatheter replacement (11.0% vs. 3.2%, P<0.001); adverse events that were more frequent after surgical replacement included major bleeding (9.3% vs. 19.5%, P<0.001) and new-onset atrial fibrillation (8.6% vs. 16.0%, P = 0.006). More patients undergoing transcatheter replacement had an improvement in symptoms at 30 days, but by 1 year, there was not a significant between-group difference. Conclusions In high-risk patients with severe aortic stenosis, transcatheter and surgical procedures for aortic-valve replacement were associated with similar rates of survival at 1 year, although there were important differences in periprocedural risks. (Funded by Edwards Lifesciences; Clinical Trials.gov number, NCT00530894.

Percutaneous Closure of Paravalvular Regurgitation After Transcatheter Aortic Valve Implantation: A Systematic Review

“…12 These rates were numerically higher than 1-year mortality in the first large trial of TAVI, which was the Placement of Aortic Transcatheter (PARTNER) trial (24.2%-30.7%). 39,40 However, most of the deaths reported by Saia et al were noncardiac (8/11, 72.7%), which was different from the PARTNER trial. In the PARTNER trial, the cardiovascular mortality rate was 56.0% to 63.6%.…”

“…In the PARTNER trial, the cardiovascular mortality rate was 56.0% to 63.6%. 39,40 This may imply that successful PCC of PVR may be associated with decreased cardiac mortality. This hypothesis may be supported by a meta-analysis by Millán et al, which showed that successful PVR reduction was associated with 612 Clin.…”

Transcatheter therapies for mitral regurgitation: A professional society overview from the american college of cardiology, the american association for thoracic surgery, society for cardiovascular angiography and interventions foundation, and the society of thoracic surgeons

“…The dissemination of this technology after its approval in the United States in the wake of a pivotal randomized trial [1,2] has thus far proceeded in a thoughtful and circumspect manner, guided by a coalition of stakeholders dedicated to the delivery of high-quality, patient-centered care. It is anticipated that a number of transcatheter therapies for mitral regurgitation (MR) will also become available for clinical use in selected patients.…”

“…The heart team approach, as utilized in the landmark SYNTAX (TAXUS Drug-Eluting Stent versus Coronary Artery Bypass Surgery for the Treatment of Transcatheter Therapies for Mitral RegurgitationNarrowed Arteries; NCT00114972) [9] and PARTNER (Placement of Aortic Transcatheter Valve; NCT00530894) [1,2] trials, and embedded in the management of patients with advanced heart failure, is now an established paradigm for the care of patients with complex coronary or aortic valve disease. This approach was also followed in EVEREST (Endovascular Valve Edge-to-Edge Repair Study), which evaluated the efficacy and safety of the MitraClip [10][11][12].…”

Aortic valve replacement after bypass surgery: surgical (SAVR) or transcatheter (TAVR)

“…Randomized trials of TAVR vs. SAVR in high and medium risk patients have included substantial numbers of patients having had previous coronary artery bypass graft surgery (CABG). The trial with the longest follow-up, Partner-1, has shown little difference at 1-and 5-year follow-up intervals for the entire patient group, although for the patient sub-group with previous CABG or PCI there was a trend toward improved survival in the SAVR arm (P=0.10) at 5 years after randomization (1,2). Despite these data, the less-invasive nature of TAVR has led to the suggestion that it is the treatment of choice for patients with previous bypass surgery because of the advanced age of many patients with previous CABG and the desire to avoid the technical challenges associated with reoperation in the face of patent bypass grafts.…”