The IX t h Makassed Medical Congress - American University of Beirut

T h e I X t h M a k a s e d M e d i c a l C o n g r e s s
PARTNER trial
Transcatheter Aortic Valve Implantation Kapadia and Tuzcu 473
Table 2. Procedural complications from transcatheter aortic valve implantation
• Stroke is an important complication of transcatheter as well as surgical
aortic valve implantation. This complication is embolic in origin and
thought to be a result of manipulation of the devices in the ascending
aorta and arch. It was thought that embolic stroke would be more
frequent with the retrograde approach, but data suggest that stroke is
equally common with the transapical approach (Table 2). This outcome
may be a result of the fact that intracardiac introduction of devices
through the apical sheath may lead to cerebral embolization. It also has
been observed that strokes commonly occur in cortical watershed zones
with the transapical approach, raising the possibility that hemodynamic
instability or preexisting cerebrovascular disease may contribute to some
strokes with this technique. Careful imaging of the aorta and screening
for carotid disease may help identify patients at higher risk for stroke.
• The PARTNER trial is a randomized prospective study designed to assess
the safety and effi cacy of the Edwards Sapien percutaneous valve in highrisk
patients with symptomatic severe AS. The primary end point is 1-year
mortality. This study has two independently powered arms. One, powered
to prove superiority, will compare outcomes of patients who are deemed
inoperable and then randomly assigned to receive best available therapy
(medical with or without balloon valvuloplasty) or transcatheter AVR.
Enrollment has been completed in this arm of the study, with 350 patients.
The 1-year outcome data will be available by the end of 2009. The second
cohort, powered to prove noninferiority, will compare outcomes of patients
who are at high surgical risk (> 15% operative mortality). These patients
then will be randomly assigned to TAVI or SAVR. The transapical approach
88
Complications, %
Study Vascular Stroke Pacemaker MI Other major
Edwards Sapien valve*: transfemoral
REVIVE/REVIVAL [32] 15.6 4.3 4.9 3.7 3
Vancouver [33] – 5.0 4.0 – –
PARTNER EU [34] 14.8 3.6 1.8 1.8 5.4
SOURCE [34]
CoreValve
7.4 3.4 – 1.0 2.4
† : transfemoral
Grube et al. [35•] – 10/8.3/2.9 ‡ 10/13.6/33.3 ‡ 0/4.2/2.0 ‡ 40/20.8/3.7 ‡
Bleiziffer et al. [36] 11.7 5.1 19.7 – –
Tamburino et al. [37] 16.6 – 20 2.0 3
Laborde [38] 6.2 2.5 18.4 0.7 5.7
Edwards-Sapien valve*: transapical
REVIVE/REVIVAL [32] 15.6 4.3 4.9 – 3
Vancouver [33] – 5.0 4.0 – –
PARTNER EU [34] 14.8 3.6 1.8 1.8 5.4
SOURCE [34]
*Edwards Lifesciences, Irvine, CA.
† Medtronic, Minneapolis, MN.
7.4 3.4 – 1.0 2.4
‡ For 25F, 21F, and 18F systems, respectively.
MI—myocardial infarction; PARTNER EU—Placement of Aortic Transcatheter Valve; REVIVAL—Transcatheter Endovascular Implantation
of Valves; REVIVE—Registry of Endovascular Implantation of Valves in Europe; SOURCE—Edwards Sapien Aortic Bioprosthesis European
Outcome Registry.