TAVR or Surgery for Patients with Severe Aortic Stenosis and Intermediate Surgery Risk?

Mortality and stroke at 2 years were similar with surgery and transcatheter aortic-valve replacement, but different adverse events were associated with each procedure.

Research continues into expanded indications for transcatheter aortic-valve replacement (TAVR). In this manufacturer-funded, 87-site randomized trial (NCT01586910), TAVR with a self-expanding prosthesis was compared with surgery in patients who had severe aortic stenosis and were at intermediate risk for surgery (mean Society of Thoracic Surgeons–Predicted Risk of Mortality score, 4.4%). With 71 patients randomized to surgery not undergoing the procedure, a modified intention-to-treat analysis was used on 1660 patients (mean age, 80). TAVR was conducted via transfemoral (94%), subclavian, or direct aortic access.

The primary endpoint, death or disabling stroke at 2 years, occurred in 12.6% of the TAVR group and 14.0% of the surgery group, a nonsignificant difference. At 30 days, surgery was associated with acute kidney injury and atrial fibrillation. TAVR was associated with major vascular complications, moderate or severe paravalvular aortic regurgitation (PAR; 5.3% at 1 year), and new permanent pacemakers (29% of patients without a pre-existing device). Mean aortic-valve area at 2 years was larger after TAVR (2.2 cm²) than after surgery (1.7 cm²).

Comment

In this trial, TAVR with a self-expanding prosthesis was noninferior to surgery for intermediate-risk patients with severe and symptomatic aortic stenosis. This confirms earlier results with a balloon-expandable device in PARTNER 2A (NEJM JW Cardiol May 2016 and N Engl J Med 2016; 374:1609). The findings will likely lead to an FDA indication for the self-expanding device in this patient population. This is good news for patients and supports the continued study of both devices in even lower-risk patients. The rate of new pacemakers is notably higher than in earlier studies of this device or in PARTNER 2A, and it remains unclear whether low rates of both PAR and new pacemaker implantation can be achieved. How the various devices, particularly the latest-generation ones, would compare head-to-head remains unknown.

Reviewing Author

Howard C. Herrmann, MD

Disclosures

Consultant/Advisory BoardAffluent Medical; Artedrone; Caranx; Johnson & Johnson; Medtronic; Prolifagen; Wells Fargo

EquityMicrointerventional Devices, Inc.

RoyaltiesUniversity of Pennsylvania

Grant/Research SupportAbbott Vascular; Edwards Lifesciences; Johnson & Johnson; Medtronic

Editorial BoardsCatheterization and Cardiovascular Interventions; Journal of the American College of Cardiology; Circulation: Cardiovascular Interventions; JACC Cardiovascular Interventions; JACC Case Reports; JSCAI

Leadership Positions in Professional SocietiesHeart Valve Collaboratory (Scientific Committee Member, Chair of the Publications Committee)