Abbott Tendyne Gebrauchsanweisung Seite 31

• a minimum neo-LVOT area of 250mm
at least 5mm of tether length within the
•
ventricle,
• the valve does not interfere with ventricular
wall tissue,
• the ventricular access site does not
approximate the coronary vessel anatomy or
transverse the right ventricle,
• the native anterior mitral leaflet is not at risk
for Systolic Anterior Motion (SAM) causing
LVOT obstruction.
Patients should first be evaluated for a Standard Profile
(SP) valve, and in those without suitable anatomy, a Low
Profile (LP) valve should be considered. For subjects
receiving LP valves, the predicted neoLVOT averaged
over end-systole and end-diastole is recommended to
be larger than 325mm 2 .
Additional evaluation may be required to confirm the
following:
For subjects with severely restricted or
•
immobile leaflets, confirm that balloon
valvuloplasty can be performed to mobilize the
leaflets and permit delivery sheath access
through the mitral annulus.
• For subjects with prior AVR, confirm that the
aortic valve frame or sewing ring will not
interfere with the Tendyne valve expansion by
confirming a sufficient diameter for the inner
valve frame for the selected profile (22.5 mm
for LP valves, 27.0 mm for SP valves).
For subjects with a prior AVR, and the aortic
•
valve prosthesis is implanted in a position that
is partially below the native aortic valve or in
the LV outflow tract; use the CT simulation of
the Tendyne valve to assess for any interaction
of the Tendyne valve outer frame with the
aortic prosthesis in the left ventricle that is
expected to cause significant deformation of
the aortic prosthesis.
This device is not intended to treat children, or pregnant
or nursing women.
Pre-existing co-morbid conditions that increase the risk
of poor initial results or the risk of emergency referral
for surgery should be reviewed.
TM
IFU, TENDYNE Mitral Valve System
2 , Carefully consider the risks and benefits for each patient
before using the Tendyne Mitral Valve System.
The Tendyne Expanded Clinical Study consisted of the first
100 patients treated with the Tendyne Mitral Valve System
followed through one-year post-procedure. Data obtained
from this study in patients with symptomatic, severe MR
who were not suitable for surgical treatments showed the
following outcomes (Table 4):
Table 4: 1-Year Outcomes of the Tendyne Expanded
Clinical Study
1-Year Outcome
Trace or less MR
NYA Class I/II
KCCQ Improvement
• Improved at least 5 pts
• Improved at least 10 pts
6 Minute Walk Distance
Improvement
Improved at least 24 m
•
• Improved at least 50 m
While the clinical data observed during the Tendyne
Expanded Clinical Study demonstrate clinical benefit for
patients with severe mitral regurgitation and who are
poor candidates for either traditional mitral valve
surgery or transcatheter mitral repair, there is limited
long-term (>1 yr) data regarding the safety and
performance of the Tendyne Mitral Valve System. As
such, the long-term risks and benefits have not been
established.
12. Patient Counseling
The risks and benefits of long-term antiplatelet therapy
or anticoagulant therapy should be considered. Long-
term anticoagulation therapy, unless contraindicated, is
recommended for all patients with bioprosthetic heart
valves who have risk factors for thromboembolism.
Patients with bioprostheses who undergo dental
procedures that involve manipulation of gingival tissue
or the periapical region of the teeth, or perforation of
the oral mucosa should receive endocarditis
prophylactic antibiotic therapy.
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n/N(%)
61/62 (98.4%)
54/61 (88.5%)
52/64 (81.3%)
47/64 (73.4%)
34/55 (61.8%)
27/55 (49.1%)