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
Complications
Transcatheter Aortic Valve Implantation Kapadia and Tuzcu 471
• These initial experiences led to the development of multicenter registries
from the United States (REVIVAL II [Transcatheter Endovascular Implantation
of Valves II] trial), the European Union (REVIVE II [Registry of
Endovascular Implantation of Valves in Europe II]), and Canada (Canadian
Special Access), which included patients with a valve area ≤ 0.8 cm 2 and
high predicted operative mortality. REVIVAL II included patients treated
with both the transfemoral and transapical approaches. Of the 55 transfemoral
patients, the procedure was successful in 87%; the 26-mm valve was
used in 62% of the patients. The 30-day observed mortality rate was 7.8%.
The transapical cohort had survival rates of 81.8% ± 6.2% at 1 month and
71.7% ± 7.7% at 3 months [28].
• The fi rst human recipient of the CoreValve aortic prosthesis was reported
in 2005 by Grube et al. [29]. The CoreValve system has progressed in a
manner similar to that of the Edwards valve system in the several stepwise
advances made to the device, deployment techniques, and patient selection.
The initial study, in 25 patients, used general anesthesia with extracorporeal
support and femoral access via a surgical arterial cutdown. With
the change from a bovine to porcine valve, the system decreased in size
from 24F to 21F, and the third-generation device is 18F. In the second intention-to-treat
series, the CoreValve was implanted in 50 and 36 patients
using second-generation (21F) and third-generation (18F) devices, respectively
[30]. A vascular closure device was used in all patients following
percutaneous access (18F system) [30]. The composite periprocedural rate
of death, stroke, and myocardial infarction was 14% [30]. The overall 30day
mortality rate was 12%, whereas the combined rate of death, stroke,
and myocardial infarction at 30 days was 22% [30].
• Based on these initial data, the CoreValve and Edwards Sapien valve were
approved in Europe under the CE mark in 2007 and in several other non-
US countries thereafter. Approval led to a rapid increase in the number of
percutaneous heart valve implants. By mid-2009, approximately 4000 each
of the CoreValve and Edwards Sapien valves were implanted worldwide. The
PARTNER EU (Placement of Aortic Transcatheter Valve) trial was a feasibility
study conducted in the European Union before the Edwards Sapien valve
was granted the CE mark in Europe. European experience after the CE mark
approval has been collected in the SOURCE registry (Edwards Sapien Aortic
Bioprosthesis European Outcome Registry). Data from these two registries
have been presented at various national and international meetings. The aggregate
procedural and outcome data are presented in Table 1.
• Both valves are reported to have several procedural complications,
some of which can be prevented by proper patient selection and careful
procedural monitoring. Complications can be classifi ed into access
site–related complications, malpositioning of the valve (valve embolization,
paravalvular regurgitation), compromise of surrounding structures
(coronary ostia, conduction system, mitral valve), and systemic
complications (eg, stroke, infection, bleeding).
• The rate of access site–related complications was as high as 30% in earlier
experiences, and these usually were associated with signifi cant mortality.
With proper patient selection based on preprocedural CT angiography
and, at times, intravascular ultrasound, the complication rate has decreased
to as low as 5% to 6%. Femoral access complications include arterial
rupture, dissection, and, occasionally, limb ischemia. Apical bleeding
and pseudoaneurysm have been reported with the apical approach.
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