CardioSource WorldNews | Page 60
indiCations The Medtronic CoreValve and CoreValve Evolut R systems are indicated for use
in patients with symptomatic heart disease due to either severe native calcific aortic stenosis or
failure (stenosed, insufficient, or combined) of a surgical bioprosthetic aortic valve who are judged
by a heart team, including a cardiac surgeon, to be at high or greater risk for open surgical therapy
(ie, Society of Thoracic Surgeons predicted risk of operative mortality score ≥8% or at a ≥15% risk
of mortality at 30 days).
ContRaindiCations The CoreValve and CoreValve Evolut R systems are contraindicated for
patients presenting with any of the following conditions: known hypersensitivity or contraindication
to aspirin, heparin (HIT/HITTS) and bivalirudin, ticlopidine, clopidogrel, Nitinol (Titanium or Nickel),
or sensitivity to contrast media, which cannot be adequately premedicated; ongoing sepsis,
including active endocarditis; preexisting mechanical heart valve in aortic position.
WaRnings General Implantation of the CoreValve and CoreValve Evolut R systems should be
performed only by physicians who have received Medtronic CoreValve training. This procedure
should only be performed where emergency aortic valve surgery can be performed promptly.
Mechanical failure of the delivery catheter system and/or accessories may result in patient
complications. Transcatheter Aortic Valve (Bioprosthesis) Accelerated deterioration of the
bioprosthesis may occur in patients presenting with an altered calcium metabolism.
PRECautions General The safety and effectiveness of the CoreValve and CoreValve Evolut R
systems have not been evaluated in the pediatric population. The safety and effectiveness of
the bioprosthesis for aortic valve replacement have not been evaluated in the following patient
populations: patients who do not meet the criteria for symptomatic sever native aortic stenosis
as defined: (1) symptomatic severe hi gh gradient aortic stenosis – aortic valve area ≤1.0cm2 or
aortic valve area index ≤0.6 cm2/m2, a mean aortic valve gradient ≥40 mmHg; or a peak aortic-jet
velocity ≥4.0 m/s, (2) symptomatic severe low-flow/low-gradient aortic stenosis – aortic valve
area ≤1.0cm2 or aortic valve area index ≤0.6 cm2/m2, a mean aortic valve gradient <40 mmHg; and a
peak aortic-jet velocity <4.0 m/s ; who are at moderate or low surgical risk (predicted perioperative
mortality risk of <15%); with untreated, clinically significant coronary artery disease requiring
revascularization; with a preexisting prosthetic heart valve with a rigid support structure in
either the mitral or pulmonic position if either the preexisting prosthetic heart valve could affect
the implantation or function of the bioprosthesis or the implantation of the bioprosthesis could
affect the function of the preexisting prosthetic heart valve; with cardiogenic shock manifested
by low cardiac output, vasopressor dependence, or mechanical hemodynamic support. The safety
and effectiveness of a CoreValve or CoreValve Evolut R bioprosthesis implanted within a failed
preexisting transcatheter bioprosthesis has not been demonstrated. Implanting a CoreValve or
CoreValve Evolut R bioprosthesis in a degenerated surgical bioprosthesis [transcatheter aortic
valve in surgical aortic valve (TAV in SAV)] should be avoided in the following conditions. The
degenerated surgical bioprosthesis presents with a: significant concomitant perivalvular leak
(between the prosthesis and the native annulus), is not securely fixed in the native annulus, or is
not structurally intact (eg, wireform frame fracture); partially detached leaflet that in the aortic
position may obstruct a coronary ostium; stent frame with a manufacturer’s labeled inner diameter
<17 mm. The safety and effectiveness of the bioprosthesis for aortic valve replacement have not
been evaluated in patient populations presenting with the following: blood dyscrasias as defined:
leukopenia (WBC <1000 cells/mm3), thrombocytopenia (platelet count <50,000 cells/mm 3), history
of bleeding diathesis or coagulopathy, or hypercoagulable states; congenital bicuspid or unicuspid
valve; mixed aortic valve disease (aortic stenosis and aortic regurgitation with predominant aortic
regurgitation [3-4+]); moderate to severe (3-4+) or severe (4+) mitral or severe (4+) tricuspid
regurgitation; hypertrophic obstructive cardiomyopathy; new or untreated echocardiographic
evidence of intracardiac mass, thrombus, or vegetation; native aortic annulus size <18 mm or >29
mm for CoreValve and <18 mm or >26 mm for CoreValve Evolut R per the baseline diagnostic imaging
or surgical bioprosthetic aortic annulus size <17 mm or >29 mm for CoreVavle and <17 mm or >26
mm for CoreValve Evolut R; transarterial access not able to accommodate an 18-Fr sheath or the
14-Fr equivalent EnVeo R InLine sheath; sinus of valsalva anatomy that would prevent adequate
coronary perfusion; moderate to severe mitral stenosis; severe ventricular dysfunction with left
ventricular ejection fraction (LVEF) <20%;; symptomatic carotid or vertebral artery disease; severe
basal septal hypertrophy with an outflow gradient.
Prior to Use Exposure to glutaraldehyde may cause irritation of the skin, eyes, nose, and throat.
Avoid prolonged or repeated exposure to the vapors. Damage may result from forceful handling
of the catheter. Prevent kinking of the catheter when removing it from the packaging.This device
was designed for single patient use only. Do not reuse, reprocess, or resterilize this product. Reuse,
reprocessing, or resterilization may compromise the structural integrity of the device and/or
create a risk of contamination of the device, which could result in patient injury, illness, or death.
The bioprosthesis size must be appropriate to fit the patient’s anatomy. Proper sizing of the device
is the responsibility of the physician. Refer to Instructions for Use for available sizes. Failure to
implant a device within the sizing matrix could lead to adverse effects such as those listed below.
Patients must present with access vessel diameters of ≥6 mm for the CoreValve system and ≥5 mm
for the CoreValve Evolut R system or an ascending aortic (direct aortic) access site ≥60 mm from the
basal plane for both systems. Implantation of the bioprosthesis should be avoided in patients with
aortic root angulation (angle between plane of aortic valve annulus and horizontal plane/vertebrae)
of >30° for right subclavian/axillary access or >70° for femoral and left subclavian/axillary access.
Use caution when using the subclavian/axillary approach in patients with a patent LIMA graft or
patent RIMA graft. For direct aortic access, ensure the access site and trajectory are free of patent
RIMA or a preexisting patent RIMA graft.
During Use For direct aortic and subclavian access procedures, care must be exercised when
using the tip-retrieval mechanism to ensure adequate clearance to avoid advancement of the
catheter tip through the bioprosthesis leaflets during device closure. For direct aortic access
procedures, use a separate introducer sheath; do not use the EnVeo R InLine sheath. Adequate
rinsing of the bioprosthesis with sterile saline, as described in the Instructions for Use, is mandatory
before implantation. During rinsing, do not touch the leaflets or squeeze the bioprosthesis.
If a capsule becomes damaged during loading or the capsule fails to close, replace the entire
system (bioprosthesis, catheter, and CLS). Do not use a catheter with a damaged capsule. After a
bioprosthesis has been inserted into a patient, do not attempt to reload that bioprosthesis on the
same or any other catheter. AccuTrak DCS Only: During implantation, if resistance to deployment is
encountered (e.g., the micro knob starts clicking or is tight or stuck), apply upward pressure to the
macro slider while turning the micro knob. If the bioprosthesis still does not deploy, remove it from
the patient and use another system. AccuTrak DCS Only: Once deployment is initiated, retrieval
of the bioprosthesis from the patient (e.g., use of the catheter) is not recommended. Retrieval of
a partially deployed valve using the catheter may cause mechanical failure of the delivery catheter
system, aortic root damage, coronary artery damage, myocardial damage, vascular complications,
prosthetic valve dysfunction (including device malposition), embolization, stroke, and/or emergent
surgery. AccuTrak DCS Only: During deployment, the bioprosthesis can be advanced or withdrawn
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as long as annular contact has not been made. Once annular contact is made, the bioprosthesis
cannot be advanced in the retrograde direction; if necessary, and the frame has only been deployed
≤2/3 of its length, the bioprosthesis can be withdrawn (repositioned) in the antegrade direction.
However, use caution when moving the bioprosthesis in the antegrade direction. EnVeo R DCS
Only: If a misload is detected, unsheath the bioprosthesis and examine the bioprosthesis for
damage (for example, permanent frame deformation, frayed sutures, or valve damage). Do not
attempt to reload a damaged bioprosthesis. Do not load the bioprosthesis onto the catheter more
than 2 times or after it has been inserted into a patient. EnVeo R DCS Only: Use the deployment
knob to deploy and recapture the bioprosthesis. Do not use the trigger for deploying or recapturing
because it could cause inaccurate placement of the bioprosthesis. EnVeo R DCS Only: Once the
radiopaque capsule marker band reaches the distal end of the radiopaque paddle attachment (point
of no recapture), retrieval of the bioprosthesis from the patient is not recommended. Retrieval after
the point of no recapture may cause mechanical failure of the delivery catheter system, aortic root
damage, coronary artery damage, myocardial damage, vascular complications, prosthetic valve
dysfunction (including device malposition), embolization, stroke, and/or emergent surgery. EnVeo
R DCS Only: During deployment, the bioprosthesis can be advanced or withdrawn as long as annular
contact has not been made. Once annular contact is made, the bioprosthesis cannot be advanced
in the retrograde direction; recapture until the bioprosthesis is free from annular contact, and then
reposition in the retrograde direction. If necessary, and the radiopaque capsule marker band has not
yet reached the distal end of the radiopaque paddle attachment, the bioprosthesis can be withdrawn
(repositioned) in the antegrade direction. However, use caution when moving the bioprosthesis
in the antegrade direction. While the catheter is in the patient, ensure the guidewire is extending
from the tip. Do not remove the guidewire from the catheter while the catheter is inserted in the
patient. Use the handle of the delivery system to reposition the bioprosthesis. Do not use the outer
catheter sheath. Once deployment is complete, repositioning of the bioprosthesis (e.g., use of a
snare and/or forceps) is not recommended. Repositioning of a deployed valve may cause aortic root
damage, coronary artery damage, myocardial damage, vascular complications, prosthetic valve
dysfunction (including device malposition), embolization, stroke, and/or emergent surgery. Do not
attempt to retrieve or to recapture (EnVeo DCS only) a bioprosthesis if any one of the outflow struts
is protruding from the capsule. If any one of the outflow struts has deployed from the capsule,
the bioprosthesis must be released from the catheter before the catheter can be withdrawn.
Ensure the capsule is closed before catheter removal. When using a separate introducer sheath, if
increased resistance is encountered when removing the catheter through the introducer sheath,
do not force passage. Increased resistance may indicate a problem and forced passage may result
in damage to the device and/or harm to the patient. If the cause of resistance cannot be determined
or corrected, remove the catheter and introducer sheath as a single unit over the guidewire, and
inspect the catheter and confirm that it is complete. Clinical long-term durability has not been
established for the bioprosthesis. Evaluate bioprosthesis performance as needed during patient
follow-up. Postprocedure, administer appropriate antibiotic prophylaxis as needed for patients
at risk for prosthetic valve infection and endocarditis. Postprocedure, administer anticoagulation
and/or antiplatelet therapy per physician/clinical judgment. Excessive contrast media may
cause renal failure. Preprocedure, measure the patient’s creatinine level. During the procedure,
monitor contrast media usage. Conduct the procedure under fluoroscopy. The safety and efficacy
of a CoreValve or CoreValve Evolut R bioprosthesis implanted within the initial transcatheter
bioprosthesis have not been demonstrated. However, in the event that a CoreValve or CoreValve
Evolut R bioprosthesis must be implanted within the initial transcatheter bioprosthesis to improve
valve function, valve size and patient anatomy must be considered before implantation of the
bioprosthesis to ensure patient safety (for example, to avoid coronary obstruction). In the event
that valve function or sealing is impaired due to excessive calcification or incomplete expansion,
a postimplant balloon dilatation of the bioprosthesis may improve valve function and sealing. To
ensure patient safety, valve size and patient anatomy must be considered when selecting the
size of the balloon used for dilatation. The balloon size chosen for dilatation should not exceed
the diameter of the native aortic annulus or, for surgical bioprosthetic valves, the manufacturer’s
labeled inner diameter. Refer to the specific balloon catheter manufacturer’s labeling for proper
instruction on the use of balloon catheter devices. Note: Bench testing has only been conducted
to confirm compatibility with NuMED Z-MED IITM Balloon Aortic Valvuloplasty catheters where
CoreValve or CoreValve Evolut R biop rosthesis device performance was maintained after dilation.
Data on File.
PotEntial adVERsE EVEnts Potential risks associated with the implantation of the CoreValve
or CoreValve Evolut R transcatheter aortic valve may include, but are not limited to, the following:
• death • myocardial infarction, cardiac arrest, cardiogenic shock, cardiac tamponade • coronary
occlusion, obstruction, or vessel spasm (including acute coronary closure) • cardiovascular injury
(including rupture, perforation, tissue erosion, or dissection of vessels, ascending aorta trauma,
ventricle, myocardium, or valvular structures that may require intervention) • emergent surgical
or transcatheter intervention (for example, coronary artery bypass, heart valve replacement,
valve explant, percutaneous coronary intervention [PCI], balloon valvuloplasty) • prosthetic valve
dysfunction (regurgitation or stenosis) due to fracture; bending (out-of-round configuration) of the
valve frame; underexpansion of the valve frame; calcification; pannus; leaflet wear, tear, prolapse,
or retraction; poor valve coaptation; suture breaks or disruption; leaks; mal-sizing (prosthesispatient mismatch); malposition (either too high or too low)/malplacement • prosthetic valve
migration/embolization • prosthetic valve endocarditis • prosthetic valve thrombosis • delivery
catheter system malfunction resulting in the need for additional re-crossing of the aortic valve
and prolonged procedural time • delivery catheter system component migration/embolization •
stroke (ischemic or hemorrhagic), transient ischemic attack (TIA), or other neurological deficits •
heart failure • cardiac failure or low cardiac output • ancillary device embolization • individual organ
(for example, cardiac, respiratory, renal [including acute kidney failure]) or multi-organ insufficiency
or failure • major or minor bleeding that may require transfusion or intervention (including lifethreatening or disabling bleeding) • vascular access-related complications (eg, dissection,
perforation, pain, bleeding, hematoma, pseudoaneurysm, irreversible nerve injury, compartment
syndrome, arteriovenous fistula, stenosis) • mitral valve regurgitation or injury • conduction
system disturbances (for example, atrioventricular node block, left-bundle branch block, asystole),
which may require a permanent pacemaker • infection (including septicemia) • hypotension or
hypertension • hemolysis • peripheral ischemia • bowel ischemia • abnormal lab values (including
electrolyte imbalance) • allergic reaction to antiplatelet agents, contrast medium, or anesthesia •
exposure to radiation through fluoroscopy and angiography • permanent disability.
Please reference the CoreValve and CoreValve Evolut R Instructions for Use for more
information regarding indications, warnings, precautions and potential adverse events.
CAUTION Federal law (USA) restricts this device to sale by or on
the order of a physician.
lifeline
CardioVascular technical support
Tel: (877) 526-7890
Tel: (763) 526-7890
Fax: (763) 526-7888
E-mail: [email protected]
CoreValve is a registered trademark of Medtronic CV Luxembourg S.a.r.l.
Evolut is a trademark of Medtronic.
UC201606259 EN
©2016 Medtronic. All rights reserved. 2/2016