SCA Bulletin Home

Print Issue as PDF

See Full Table of Contents

In this Edition

sCA Annual Meeting

SCA News

Literature Review

SCA SALARY SURVEY DATA

Echo Corner


SCA Newsletter Committee


SCA Foundation

 

SCA Quick Links



Literature Review

Surgical or Transcatheter Aortic Valve Replacement in Intermediate-Risk Patients

Reardon MJ, Van Mieghem NM, Popma JJ, et al. N Engl J Med. 2017;376(14):1321-1331.

Reviewers: Ahmed S. Awad, MD1; Ronak G. Desai, DO1

  1. Assistant professor of anesthesiology, Cooper Medical School of Rowan University, Camden, NJ
Background

In patients with severe, symptomatic aortic stenosis who present with a prohibitive risk for conventional surgical aortic valve replacement (SAVR), an alternative technique—transcatheter aortic valve replacement (TAVR)—has been shown to be noninferior in terms of all-cause mortality. Recently, a randomized trial comparing balloon-expandable TAVR to SAVR in patients possessing intermediate risk factors for surgery demonstrated noninferiority regarding mortality at 2 years. However, the TAVR group had higher rates of permanent pacemaker use and residual aortic regurgitation. This study, the SURTAVI trial, was designed to compare the safety and efficacy of the self-expanding TAVR bioprosthesis and SAVR in intermediate surgical risk patients.

Methods

The SURTAVI trial was conducted at 87 centers internationally, and eligible intermediate surgical risk patients with severe, symptomatic aortic stenosis underwent 1:1 randomization to undergo TAVR with the self-expanding bioprosthesis or SAVR. The intermediate surgical risk was defined as an estimated risk of 30-day surgical death of 3%–15%, according to the criteria of the STS Predicted Risk of Mortality as well as coexisting illness, disability, and frailty. SAVR patients were permitted to have coronary revascularization if needed, and the choice and size of valve was at the discretion of the surgeon. If revascularization was performed, aspirin 81 mg was prescribed indefinitely, even in the presence of warfarin. Preprocedural CT determined the size of the bioprosthesis and access site in the TAVR group. Percutaneous coronary intervention, when indicated, was performed either before TAVR or at the time of TAVR, and DAPT was continued for at least 3 months. Embolic protection devices were not allowed in either group. Death from any cause or disabling stroke at 24 months was the primary endpoint.  

Results

A total of 1,746 patients underwent randomization, and 1,660 patients were included in the analysis (TAVR: 864, SAVR: 796). Twenty percent of patients in the two groups underwent coronary revascularization. At 24 months, the incidence of the primary endpoint was 12.6% in the TAVR group and 14.0% in the SAVR group. Secondary endpoints demonstrated more vascular complications, higher rates of residual aortic regurgitation, and the need for permanent pacemaker placement in the TAVR group and higher rates of blood transfusion, new or worsening atrial fibrillation, and acute kidney injury in the SAVR group. The TAVR group had lower mean aortic valve gradients and larger aortic valve areas than the SAVR group. Structural valve deterioration was not seen in either group. No differences regarding the trial site or geographic region were found. 

Discussion

The SURTAVI trial demonstrated that the 24-month risk of mortality and disabling stroke was similar in intermediate surgical risk patients who underwent TAVR or SAVR. Many landmark trials have shown that in high-risk patients undergoing TAVR, a mortality benefit is conferred likely due to the delayed recovery from surgical complications. However, this trial assessing intermediate risk patients demonstrated noninferiority when comparing TAVR to SAVR. Ultimately, more long-term follow-up is needed to better understand the life cycle of the TAVR prosthesis.

Comments

TAVR has previously been shown to be noninferior to SAVR in high-surgical-risk patients. The PARTNER IIA recently revealed that in intermediate-risk patients, the balloon-expandable TAVR prosthesis provided equal safety and efficacy compared to surgery. However, no large-scale trials were utilizing the self-expanding TAVR prosthesis until the SURTAVI trial. In this trial, the authors uncovered that in intermediate-risk patients, the primary endpoints of death by any cause or disabling stroke at 24 months were similar when comparing the self-expanding TAVR prosthesis or SAVR. The major adverse events in the TAVR group were higher residual aortic regurgitation and pacemaker use. In the SAVR group, there were greater rates of transfusion, atrial fibrillation, and acute kidney injury. Although Medtronic developed the protocol, the data overwhelmingly demonstrate the safety of TAVR in intermediate risk patients. However, further study is warranted to understand truly the life cycle of the TAVR prosthesis.

Mindray Anesthesia Workstation