Author + information
- Jochen Wöhrle1,
- David Hildick-Smith2,
- Sabine Bleiziffer3,
- Daniel Blackman4,
- Mohamed Abdel-Wahab5,
- Dominic Allocco6,
- Ian Meredith7,
- Volkmar Falk8 and
- Nicolas Van Mieghem9
- 1University Hospital Ulm, Ulm, Germany
- 2Royal Sussex County Hospital, Brighton, United Kingdom
- 3German Heart Center Munich, Munich, Germany
- 4Leeds General Infirmary, Leeds, United Kingdom
- 5Heart Center, Segeberger Kliniken, Bad Segeberg, Germany
- 6Boston Scientific, Maple Grove, Minnesota, United States
- 7Boston Scientific Corporation, Marlboro, Massachusetts, United States
- 8Deutsches Herzzentrum Berlin, Klinik für Herz-Thorax-Gefässchirurgie, Berlin, Germany
- 9Thoraxcenter, Erasmus Medical Center, Rotterdam, Netherland
Transcatheter aortic valve implantation (TAVI) is the preferred treatment for patients with symptomatic aortic stenosis at high risk for surgery; however, neurologic complications remain a concern. Here we assess the impact of embolic protection (EP) and valve repositioning on the risk of neurologic complications in patients treated with the Lotus Valve in the RESPOND study.
RESPOND enrolled 1014 TAVI patients at 41 sites across Europe, New Zealand, and Latin America (mean age: 80.8 years; STS score: 6.0±6.9). In the as-treated population (N=996) the overall stroke rate was 3.2% at 30 days and 4.9% at 1 year. For this analysis we evaluated the rate of stroke and transient ischemic attack (TIA) in patients where EP was used, and in patients where valve repositioning was performed. The decision to use EP was at the operators’ discretion. Routine assessment by a neurologist was not required per protocol; stroke events were adjudicated by an independent medical reviewer.
EP was used in 96/996 procedures (∼10%). Stroke rate with EP compared with no EP was numerically lower at hospital discharge and 30 days post procedure, but did not reach statistical significance; the rates of stroke/TIA were not significantly different between the EP and no EP groups at any time point (see Table). Repositioning of the valve was used in 31.4% of procedures (n=313/996). The rate of stroke was similar in patients with versus without valve repositioning (see Table).
|Embolic Protection||Valve Repositioning|
|EP vs No EP (N=96) (N=900)||P-value||Repos. vs No Repos. (N=313) (N=683)||P-value|
|≤72 hr Stroke||1.0% (1) vs 2.7% (24)||0.50||2.6% (8) vs 2.5% (17)||0.95|
|≤72 hr Stroke/TIA||1.0% (1) vs 3.2% (29)||0.35||4.5% (14) vs 3.2% (22)||0.86|
|Discharge Stroke||1.0% (1) vs 2.7% (24)||0.50||3.2% (10) vs 3.1% (21)||0.92|
|Discharge Stroke/TIA||1.0% (1) vs 3.2% (29)||0.35||3.5% (11) vs 3.7% (25)||0.91|
|30-day Stroke||1.0% (1) vs 3.4% (31)||0.36||3.5% (11) vs 3.1% (21)||0.71|
|30-day Stroke/TIA||2.1% (2) vs 4.1% (37)||0.58||4.2% (13) vs 3.8% (26)||0.79|
TAVI procedures with the Lotus valve had low rates of neurological complications. Neurological events were numerically lower where EP was used, compared with no EP use, without a significant statistical difference. Valve repositioning was not associated with an increased risk of neurologic events in the RESPOND study.
STRUCTURAL: Valvular Disease: Aortic