J Am Coll Cardiol. 2018 Oct 30;72(18):2109-2119. doi: 10.1016/j.jacc.2018.07.093.

Neurological Complications After Transcatheter Versus Surgical Aortic Valve Replacement in Intermediate-Risk Patients.

Durko AP¹, Reardon MJ², Kleiman NS², Popma JJ³, Van Mieghem NM⁴, Gleason TG⁵, Bajwa T⁶, O'Hair D⁶, Brown DL⁷, Ryan WH⁷, Chang Y⁸, De Leon SD⁸, Kappetein AP⁹.

Author information

1: Department of Cardiothoracic Surgery, Erasmus Medical Center, Rotterdam, the Netherlands. Electronic address: a.durko@erasmusmc.nl.
2: Departments of Cardiology and Cardiovascular Surgery, Houston Methodist DeBakey Heart and Vascular Center, Houston, Texas.
3: Beth Israel Deaconess Medical Center, Boston, Massachusetts.
4: Department of Cardiology, Erasmus Medical Center, Rotterdam, the Netherlands.
5: Department of Cardiovascular Surgery, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania.
6: Departments of Cardiology and Cardiac Surgery, St. Luke's Medical Center/Aurora Health Care, Milwaukee, Wisconsin.
7: Departments of Cardiology and Cardiovascular Surgery, The Heart Hospital-Baylor Plano, Plano, Texas.
8: Clinical and Statistical Services, Medtronic, Minneapolis, Minnesota.
9: Department of Cardiothoracic Surgery, Erasmus Medical Center, Rotterdam, the Netherlands. Electronic address: https://twitter.com/AKappetein.

Abstract

BACKGROUND:

Neurological events after aortic valve interventions are associated with increased mortality and morbidity. Transcatheter aortic valve replacement (TAVR) is increasingly offered for lower-risk patients with severe aortic stenosis, previously considered candidates for surgical aortic valve replacement (SAVR). Differences in post-procedural neurological events have important implications in treatment allocation.

OBJECTIVES:

The authors sought to analyze the neurological events in the randomized SURTAVI (Surgical Replacement and Transcatheter Aortic Valve Implantation) trial.

METHODS:

Patients with severe, symptomatic aortic stenosis at intermediate surgical risk were randomized 1:1 to TAVR or SAVR. The rates of neurological events and quality of life were analyzed at 30 days, and 6 and 12 months post-procedure in a modified intention-to-treat population (mean age 79.8 ± 6.2 years; N = 1,660).

RESULTS:

The rates of early (30-day) stroke and post-procedural encephalopathy were higher after SAVR versus TAVR (5.4% vs. 3.3%; p = 0.031; and 7.8% vs. 1.6%; p < 0.001, respectively). At 12 months, the rate of stroke was not different between SAVR and TAVR (6.9% vs. 5.2%; p = 0.136). Early stroke and early encephalopathy resulted in an elevated mortality at 12 months in both treatment groups. Quality of life after an early stroke was significantly lower in SAVR versus TAVR patients at 30 days and was similar at 6 and 12 months.

CONCLUSIONS:

The early stroke rate was lower after TAVR than SAVR. In patients with early strokes, QOL improved earlier after TAVR. At 12-month follow-up, stroke rates and QOL were not different between TAVR and SAVR patients. (Surgical Replacement and Transcatheter Aortic Valve Implantation [SURTAVI]; NCT01586910).