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Percutaneous Heart Repair - 397
Can We Replace Open Heart Surgery

A (2)(n = 699) for high-risk surgical patients (Society
of Thoracic Surgeons score >10%, surgeon assessed
risk of mortality >15%) and PARTNER B(3) (n = 358,
patients inoperable by assessment of 2 surgeons).
PARTNER A patients were divided into femoral ar-
tery access transcatheter aortic valve replacement or
none (n = 207), and then randomized to open aortic
valve replacement (n = 351) or device (n = 348). Inclu-
sion criteria included valve area <0.8 cm(2), gradient
>40 mm Hg or peak >64 mm Hg, and survival >1 year.
The end point of the study was 1-year mortality.
It tried to answer two questions: 1. Was TAVR equiv-
alent to surgical AVR (PARTNER A)
2. Was TAVR better then medical therapy for inoper-
able aortic stenosis (PARTNER B)
Thirty-day mortality for PARTNER A was 3.4% for tran-
scatheter aortic valve replacement and 6.5% for aor-
Figure 3: Design changes have resulted in smaller
delivery catheters. tic valve replacement; 1-year mortality was 24.2% and
26.8%, respectively (P = .001 for noninferiority). The re-
spective prevalence of stroke was 3.8% and 2.1% (P =
Transcatheter Aortic Valve Replacemement
.2), although for all neurologic events, the difference
The original TAVR valve from Sapien was deployed in between transcatheter aortic valve replacement and
an antegrade approach using a transeptal approach aortic valve replacement was significant (P = .04), in-
due to the large size of the device and catheter. cluding 4.6% for femoral artery access transcatheter

Refinements in the valve and delivery system led to a aortic valve replacement versus 1.4% for open aortic
retrograde transfemoral, subclavian or direct thoracic valve replacement (P = .05)
approach or antegrade transapical approach. Today For PARTNER B--transcatheter aortic valve replace-
majority of TAVR are done femorally > 80%. ment versus medical treatment-30-day mortality was
5.0% versus 2.8% (P = .41), and at 1 year, mortality was
30.7% versus 50.7% (P < .001), respectively.

Similar results were seen in the Corevalve trials.
So, in High risk and inoperable patients, TAVR has
replaced surgery.

PARTNER 2(4)randomly assigned 2032 intermedi-
ate-risk patients with severe aortic stenosis, at 57
centers, to undergo either TAVR or surgical replace-
ment. The primary end point was death from any
Figure 4: A: Edwards Sapien Valve Deployment B: cause or disabling stroke at 2 years.
Medtronic Transfemoral Corevalve Deployment C:
Sapien Transapical deployment. Non-inferiority was met at 2-year follow-up, with the
primary endpoint (composite mortality or disabling
Trials of Transcatheter Aortic Valve stroke) occurring in 19.3% of TAVR versus 21.1% of
SAVR patients (P = .25). Patients were considered in-
Replacement (TAVR) termediate risk (mean STS score, 5.8%), and 76.3%
There are several TAVR valves that have been ap- of TAVR recipients were treated via the femoral ap-
proved for use in aortic stenosis. The most commonly proach.
used valves are the Edwards Sapien S3 valve (60% ) In the femoral access cohort, TAVR resulted in lower
and the Medtronic Corevalve Evolut (30%).
mortality from any cause or disabling stroke com-
The first major randomized trial that led to the FDA pared with SAVR (P = .04)
approval was the PARTNER Trial. This was a prospec- So, in Medium risk patients TAVR has replaced sur-
tive, randomized trial designed with 2 arms: PARTNER

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