http://www.theheart.org/web_slides/1242365.do A randomized clinical trial on PARTNER Cohort A stroke data comparing transcatheter aortic-valve implantation (TAVI) with surgery for severe aortic stenosis

1. PARTNER Cohort A stroke data

2. PARTNER Cohort A stroke data
C Miller (Stanford University, CA)
American Association for Thoracic Surgery 2011 Annual Meeting
• A randomized clinical trial comparing transcatheter aortic-valve implantation
(TAVI) with surgery for severe aortic stenosis in elderly patients
• Population and treatment:
Surgery-eligible patients were first stratified by whether or not they were
suitable for a fully percutaneous transfemoral intervention—patients were
deemed unsuitable for the transfemoral approach if their vessels were too
narrow for the femoral catheter to pass through
Patients deemed transfemoral eligible were randomized to either a
transfemoral TAVI procedure or surgery; those not suitable for a transfemoral
procedure were randomized to transcatheter aortic valve (transapical) or to
traditional valve-replacement surgery

3. PARTNER Cohort A stroke data: Results
• TAVI patients: 58% of the neurological events suffered were major strokes, 26%
TIAs, and 16% minor strokes
• Surgery patients: 69% of the neurological events suffered were major strokes,
25% TIAs, and 6% minor strokes
Neurological events in transfemoral-eligible stratum (as-treated analysis)
Time period Transfemoral TAVI, n=240 (%) Surgical valve replacement, n=221 (%) p
30 d 4.6 1.4 0.04
1y 6.1 1.9 0.03
Neurological events in transfemoral-ineligible stratum (as-treated analysis)
Time period Transapical TAVI, n=104 (%) Surgical valve replacement, n=92 (%) p
30 d 7.9 5.5 0.5
1y 14.1 9.7 0.37
TIA: transient ischemic attacks

4. PARTNER Cohort A stroke data: Commentary*
"The higher observed incidence of neurological events in the 'non-transfemoral
candidate' stratum reflected the patient substrate and was not related to the
transapical-TAVI or surgical procedures per se."
- Dr Craig Miller
"[Collaboration will make] sure that [TAVI] gets rolled out with high quality and will
have the side benefit of keeping it from going nuts like it has in Europe."
- Dr John Mayer
"We have absolutely no clue if these strokes were device related or not."
- Dr Michael Mack
*All comments from PARTNER A: Stroke with TAVI speaks to arteriosclerotic burden, baseline risk
(http://www.theheart.org/article/1222991.do) and Surgeons caution against overenthusiasm for TAVI in
light of PARTNER A stroke data (http://www.theheart.org/article/1223675.do)

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