A comprehensive analyzis of cerebrovascular events in major randomized controlled studies on transcatheter aortic valve replacement (TAVR) has shown some interesting data on both risks and timing of stroke in this setting.
The study carried out by Dr. Neal Kleiman, reviewed data on stroke and stroke predictors among 3,687 patients included in the CoreValve pivotal trial. Stroke rate at one year post implantation with the self-expandable CoreValve was 8.4% and nearly half of these events happened within the first 10 days.
In a similar study, Dr. Samir Kapadia reviewed stroke rate in 2,621 patients included in the PARTNER study. Stroke rate for the balloon expandable Sapien was 3.3% at 30 days (85% within the first week). For patients treated via transfemoral approach, the rate was 3.8% at 30 days, 5.4% at one year and 6.9% at 3 years.
Interestingly, the studies found different predictors for stroke.
For the self-expandable CoreValve, procedural predictors included:
- Prior stroke
- Prior transient ischemic attack
- Peripheral vascular disease
- Low BMI
- A history of falls in the previous six months
Note that it did not include a history of previous myocardial revascularization surgery (CABG).
Predictors associated to the procedure itself were:
- Time in the cath lab
- Use of rapid pacing during valvuloplasty
- Need for prosthesis repositioning
Beyond 10 days, major predictors were:
- Small body
- Aortic calcification
- A history of falls
The balloon expandable valve showed different factors:
- Pre-procedural major peak gradient, higher risk of stroke for the transfemoral approach
In favor of the transapical approach were:
- Port dilation
- Pure aortic stenosis without regurgitation
- Lack of dual antiplatelet therapy
For strokes happening beyond 30 days, risk factors were:
- Dementia
- Smaller valve size
- Lower ejection fraction
- Atrial fibrillation
These different factors may not necessarily indicate intrinsic differences between devices, since none of these studies were designed to assess the risk of stroke systematically. Even definitions were different between studies.
None of these data would justify not doing a TAVR procedure because of stroke risk, let alone choosing one device over the other.
Original Titles: Insights into timing, risk factors, and outcomes of stroke and transient ischemic attack after transcatheter aortic valve replacement in the PARTNER trial (Placement of Aortic Transcatheter Valves) y Neurological events following transcatheter aortic valve replacement and their predictors: a report from the CoreValve trials.
References: Kapadia S et al. Circ Cardiovasc Interv. 2016; Epub ahead of print y Kleiman NS et al. Circ Cardiovasc Interv. 2016;Epub ahead of print.
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