Medtronic CLS-3000-18F-US Instructions for Use
CoreValve™ System
Transcatheter Aortic Valve
Delivery Catheter System
Compression Loading System
Caution: Implantation of the Medtronic CoreValve™ system should be performed only by
physicians who have received Medtronic CoreValve™ training.
These devices are supplied sterile for single use only. After use, dispose of the delivery
catheter system and the compression loading system in accordance with local regulations and
hospital procedures. Do not resterilize.
Instructions for Use
Caution: Federal (USA) law restricts this device to sale by or on the order of a physician.
Trademarks may be registered and are the property of their respective owners.
Sterile LC: Device has been sterilized using Liquid Chemical
Sterilants according to EN/ISO 14160.
Explanation of symbols on package labeling
Use By
Consult Instructions for Use at this Website
Do Not Reuse
Do Not Resterilize
Size
Serial Number
Reorder Number
Lower Limit of Temperature
Quantity
Lot Number
Sterilized Using Ethylene Oxide
Manufactured In
Nonpyrogenic
MR Conditional
Do Not Use if Package is Damaged
Manufacturer
Date of Manufacture
For US Audiences Only
Model
1
CoreValve™ Evolut™ bioprosthesis
1.0 Device description
The Medtronic CoreValve™ system consists of 3 components: the transcatheter aortic valve
(bioprosthesis)a, the delivery catheter system (catheter), and the compression loading system
(CLS).
1.1 Transcatheter aortic valve (bioprosthesis)
Figure 1
The bioprosthesis is manufactured by suturing 3 valve leaflets and a skirt, made from a single
layer of porcine pericardium, onto a self-expanding, multi-level, radiopaque frame made of
Nitinol. It is designed to replace the native or surgical bioprosthetic aortic heart valve without
open heart surgery and without concomitant surgical removal of the failed valve. The
bioprosthesis is processed with alpha-amino oleic acid (AOA™), which is an
antimineralization treatment derived from oleic acid, a naturally occurring long-chain fatty
acid.
The bioprosthesis is available for a range of aortic annulus and ascending aorta diameters as
shown in Table 1.
Table 1: Patient anatomical diameters
Bioprosthesis model Size Aortic annulus
diameter
MCS-P4-23-AOA-US 23 mm 17b/18 mm–20 mm ≤34 mm
CoreValve™ bioprosthesis
MCS-P3-26-AOA-US 26 mm 20 mm–23 mm ≤40 mm
MCS-P3-29-AOA-US 29 mm 23 mm–26 mm ≤43 mm
MCS-P3-31-AOA-US 31 mm 26 mm–29 mm ≤43 mm
Ascending aorta
diameter
1.2 Delivery catheter system (catheter)
The catheter with AccuTrak™ stability layer is compatible with a 0.035 in (0.889 mm)
guidewire. The distal (deployment) end of the system features an atraumatic, radiopaque tip
and a capsule that covers and maintains the bioprosthesis in a crimped position. The handle is
a
The terms “bioprosthesis” and “transcatheter aortic valve” are synonymous terms and are used interchangeably
throughout the document to refer to the CoreValve™ device.
b
17 mm for surgical bioprosthetic aortic annulus
2
MCS-P3-26-AOA-US,
MCS-P3-31-AOA-US
located on the proximal end of the catheter and is used to load and deploy the bioprosthesis.
The handle includes a macro slider to open and close the capsule and micro knob to facilitate
precise bioprosthesis placement. The micro knob is turned counterclockwise to load the
bioprosthesis and clockwise to deploy the bioprosthesis.
The AccuTrak™ stability layer is fixed at the handle and extends down the outside of the
catheter shaft approximately 91 cm. It provides a barrier between the retractable delivery
catheter system, introducer sheath, and vessel walls, thus enabling the catheter to retract
freely and providing a more stable platform for deployment. The outer diameter of the
catheter is 15 Fr (AccuTrak™ stability layer) and 12 Fr, and the outer diameter of the valve
capsule is 18 Fr (Figure 2). The catheter can be used for femoral, subclavian/axillary, or
ascending aortic (direct aortic) access sites. The catheter is available in 2 different models
(Table 2).
Table 2: Catheter models and system compatibility
Catheter model Corresponding CLS
DCS-C4-18F-23US CLS-3000-18F-US MCS-P4-23-AOA-US
DCS-C4-18F-US CLS-3000-18F-US
1. 112.5 cm
2. 90.9 cm
3. 15 Fr
4. 12 Fr
model
Figure 2
Corresponding
bioprosthesis model(s)
MCS-P3-29-AOA-US,
5. 18 Fr
6. 7.3 cm (Model DCS-C4-18F-US); 6.9 cm (Model DCS-C4-18F-23US)
3
1.3 Compression loading system (CLS)
The CLS compresses the bioprosthesis into the catheter. The CLS comprises the following:
Figure 3
1. Inflow tube (straight tube)
2. Outflow cone
3. Outflow cap
4. Outflow tube (tube with flared ends)
5. Inflow cone
4
2.0 Indications
The Medtronic CoreValve™ system is indicated for relief of aortic stenosis in patients with
symptomatic heart disease due to severe native calcific aortic stenosis who are judged by a
heart team, including a cardiac surgeon, to be at intermediate or greater risk for open surgical
therapy (i.e., predicted risk of surgical mortality ≥ 3% at 30 days, based on the Society of
Thoracic Surgeons (STS) risk score and other clinical comorbidities unmeasured by the STS
risk calculator).
The Medtronic CoreValve™ system is indicated for use in patients with symptomatic heart
disease due to 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 (i.e., STS predicted risk of operative mortality score ≥8% or at
a ≥15% risk of mortality at 30 days).
5
3.0 Contraindications
The CoreValve™ system is 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
6
4.0 Warnings and precautions
4.1 Warnings
4.1.1 General
• Implantation of the Medtronic CoreValve™ system should be performed only by
physicians who have received Medtronic CoreValve™ training.
• The transcatheter aortic valve is to be used only in conjunction with the delivery catheter
system and the compression loading system.
• This procedure should only be performed where emergency aortic valve surgery can be
performed promptly.
• Do not use any of the Medtronic CoreValve™ system components if any of the
following has occurred:
• It has been dropped, damaged, or mishandled in any way
• The Use By date has elapsed
• Mechanical failure of the delivery catheter system and/or accessories may result in
patient complications.
4.1.2 Transcatheter aortic valve (bioprosthesis)
• Do not use the bioprosthesis if any of the following conditions is observed:
• There is any damage to the container (e.g., cracked jar or lid, leakage, broken or
missing seals)
• The serial number tag does not match the container label
• The freeze indicator in the secondary package has activated
• The storage solution does not completely cover the bioprosthesis
• Accelerated deterioration of the bioprosthesis may occur in patients presenting with an
altered calcium metabolism.
4.2 Precautions
4.2.1 General
• Do not contact any of the Medtronic CoreValve™ system components with cotton or
cotton swabs.
• Do not expose any of the Medtronic CoreValve™ system components to organic
solvents, such as alcohol.
• Do not introduce air into the catheter.
7
• The safety and effectiveness of the Medtronic CoreValve™ system 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 severe native aortic stenosis
as defined below:
• Symptomatic severe high-gradient aortic stenosis: aortic valve area
≤1.0 cm2 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
• Symptomatic severe low-flow/low-gradient aortic stenosis: aortic valve
area ≤1.0 cm2 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 low surgical risk (predicted perioperative mortality risk of <3%)
• 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™ bioprosthesis implanted within a failed
preexisting transcatheter bioprosthesis have not been demonstrated.
• Implanting a CoreValve™ 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
(e.g., 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/mm3), history of bleeding
diathesis or coagulopathy, or hypercoagulable states
8
• Congenital bicuspid or unicuspid valve verified by echocardiography
• Mixed native 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 per the baseline diagnostic
imaging or surgical bioprosthetic aortic annulus size <17 mm or >29 mm
• Transarterial access not able to accommodate an 18 Fr 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% as measured by resting echocardiogram
• Symptomatic carotid or vertebral artery disease
• Severe basal septal hypertrophy with an outflow gradient
• Do not expose the bioprosthesis to solutions other than the storage and rinse solutions.
• Do not add antibiotics or any other substance to either the storage or rinse solutions. Do
not apply antibiotics or any other substance to the bioprosthesis.
• Do not allow the bioprosthesis to dry. Maintain tissue moisture with irrigation or
immersion.
• Do not attempt to repair a damaged bioprosthesis.
• Do not handle or use forceps to manipulate the bioprosthesis leaflet tissue.
• Do not deform the bioprosthesis in excess of what is experienced during crimping,
loading, and implantation.
4.2.2 Prior to use
• Exposure to glutaraldehyde may cause irritation of the skin, eyes, nose, and throat. Avoid
prolonged or repeated exposure to the vapors. Use only with adequate ventilation. If skin
contact occurs, immediately flush the affected area with water (minimum of 15 minutes).
In the event of eye contact, flush with water for a minimum of 15 minutes and seek
medical attention immediately.
• The bioprosthesis and the glutaraldehyde storage solution are sterile. The outside of the
bioprosthesis container is nonsterile and must not be placed in the sterile field.
• Damage may result from forceful handling of the catheter. Prevent kinking of the catheter
when removing it from the packaging.
9
• 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 Table 1 for available sizes.
Failure to implant a device within the sizing matrix could lead to adverse effects such as
those listed in Section 5.0.
• Patients must present with access vessel diameters of ≥6 mm or an ascending aortic
(direct aortic) access site ≥60 mm from the basal plane.
• 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 Left
Internal Mammary Artery (LIMA) graft (for left subclavian/axillary approach only) or
patent Right Internal Mammary Artery (RIMA) graft (for right subclavian/axillary
approach only).
• For direct aortic access, ensure the access site and trajectory are free of patent RIMA or a
preexisting patent RIMA graft.
4.2.3 During use
• Adequate rinsing of the bioprosthesis with sterile saline, as described in the Instructions
for Use, is mandatory before implantation. No other solutions, drugs, chemicals, or
antibiotics should ever be added to the glutaraldehyde or rinse solutions as irreparable
damage to the leaflet tissue, which may not be apparent under visual inspection, may
result.
• During rinsing, do not touch the leaflets or squeeze the bioprosthesis.
• With the exception of attaching the bioprosthesis frame loops to the catheter tabs, do not
touch the capsule or the transition between the capsule and the catheter shaft. To protect
the capsule, handle the catheter using the catheter shaft or, during loading, the loading
tools.
• 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.
• Prevent contamination of the bioprosthesis, its storage solution, the catheter, and the CLS
with glove powder.
• After a bioprosthesis has been inserted into a patient, do not attempt to reload that
bioprosthesis on the same or any other catheter.
• 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
10
turning the micro knob. If the bioprosthesis still does not deploy, remove it from the
patient and use another system.
• 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.
• 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.
• 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; 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.
• 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 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. 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 hospital
protocol.
• Excessive contrast media may cause renal failure. Preprocedure, measure the patient’s
creatinine level. During the procedure, monitor contrast media usage.
11
• Conduct the procedure under fluoroscopy. Fluoroscopic procedures are associated with
the risk of radiation damage to the skin, which may be painful, disfiguring, and longterm.
• The safety and efficacy of a CoreValve™ bioprosthesis implanted within a transcatheter
bioprosthesis have not been demonstrated. However, in the event that a CoreValve™
bioprosthesis must be implanted within a transcatheter bioprosthesis to improve valve
function, valve size and patient anatomy must be considered before implantation of the
CoreValve™ bioprosthesis to ensure patient safety (e.g., 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 compliance chart to ensure that the applied
inflation pressure does not result in a balloon diameter that exceeds the indicated annulus
range for the bioprosthesis. 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 II™ Balloon Aortic
Valvuloplasty catheters where CoreValve™ bioprosthesis device performance was
maintained after dilatation. Data on file.
4.3 Magnetic resonance imaging (MRI)
MRI may be used on the bioprosthesis only under specific conditions. See Section 6.2 MRI
safety information for more information.
12
5.0 Potential adverse events
Potential risks associated with the implantation of the Medtronic CoreValve™ transcatheter
aortic valve may include, but are not limited to, the following:
• Death
• Cardiac arrest
• Coronary occlusion, obstruction, or vessel spasm (including acute coronary closure)
• Emergent surgery (e.g., coronary artery bypass, heart valve replacement, valve explant)
• Multi-organ failure
• Heart failure
• Myocardial infarction
• Cardiogenic shock
• Respiratory insufficiency or respiratory failure
• Cardiovascular injury (including rupture, perforation, or dissection of vessels, ventricle,
myocardium, or valvular structures that may require intervention)
• Ascending aorta trauma
• Cardiac tamponade
• Cardiac failure or low cardiac output
• Prosthetic valve dysfunction including, but not limited to, fracture; bending (out-of-round
configuration) of the valve frame; under-expansion of the valve frame; calcification;
pannus; leaflet wear, tear, prolapse, or retraction; poor valve coaptation; suture breaks or
disruption; leaks; mal-sizing (prosthesis-patient mismatch); malposition (either too high
or too low)/malplacement; regurgitation; stenosis
• Thrombosis/embolus (including valve thrombosis)
• Valve migration/valve embolization
• Ancillary device embolization
• Emergent percutaneous coronary intervention (PCI)
• Emergent balloon valvuloplasty
• Major or minor bleeding that may or may not require transfusion or intervention
(including life-threatening or disabling bleeding)
• Allergic reaction to antiplatelet agents, contrast medium, or anesthesia
• Infection (including septicemia and endocarditis)
• Stroke, transient ischemic attack (TIA), or other neurological deficits
• Permanent disability
13
• Renal insufficiency or renal failure (including acute kidney injury)
• Mitral valve regurgitation or injury
• Tissue erosion
• Vascular access related complications (e.g., dissection, perforation, pain, bleeding,
hematoma, pseudoaneurysm, irreversible nerve injury, compartment syndrome,
arteriovenous fistula, stenosis)
• Conduction system disturbances (e.g., atrioventricular node block, left-bundle branch
block, asystole), which may require a permanent pacemaker
• Cardiac arrhythmias
• Encephalopathy
• Pulmonary edema
• Pericardial effusion
• Pleural effusion
• Myocardial ischemia
• Peripheral ischemia
• Bowel ischemia
• Heart murmur
• Hemolysis
• Cerebral infarction-asymptomatic
• Non-emergent reoperation
• Inflammation
• Fever
• Hypotension or hypertension
• Syncope
• Dyspnea
• Anemia
• Angina
• Abnormal lab values (including electrolyte imbalance)
14
6.0 Patient information
6.1 Registration information
A patient registration form is included in each bioprosthesis package. After implantation,
please complete all requested information. The serial number is located on both the package
and the identification tag attached to the bioprosthesis. Return the original form to the
Medtronic address indicated on the form and provide the temporary identification card to the
patient prior to discharge.
Medtronic will provide an Implanted Device Identification Card to the patient. The card
contains the name and telephone number of the patient’s physician as well as information
that medical personnel would require in the event of an emergency. Patients should be
encouraged to carry this card with them at all times.
6.2 MRI safety information
Nonclinical testing and modeling have demonstrated that the Medtronic CoreValve™
bioprosthesis is MR Conditional. A patient with this device can be safely scanned in an MR
system meeting the following conditions:
• Static magnetic field of 1.5 T and 3.0 T
• Maximum spatial gradient magnetic field of 2500 gauss/cm (25 T/m)
• Maximum MR system reported, whole body averaged specific absorption rate (SAR) of
≤2.0 W/kg (Normal Operating Mode)
Based on nonclinical testing and modeling, under the scan conditions defined above, the
Medtronic CoreValve™ bioprosthesis is expected to produce a maximum in vivo
temperature rise of less than 3.6˚C after 15 minutes of continuous scanning. Based on
nonclinical data, the image artifact caused by the device will extend no greater than 7 mm
from the Medtronic CoreValve™ bioprosthesis when imaged with a gradient echo pulse
sequence and a 3.0 T MRI system.
Scanning under the conditions defined above may be performed immediately after
implantation.
The presence of other implants or medical circumstances of the patient may require lower
limits on some or all of the above parameters. For deployment of a Medtronic CoreValve™
bioprosthesis inside of a failed surgical bioprosthetic valve, consult the MRI labeling
pertaining to the failed valve for additional artifact information.
15
7.0 How supplied
7.1 Packaging
The bioprosthesis is supplied sterile and nonpyrogenic in a sealed container made of glass
and a screw cap with a liner. The outside of the container is nonsterile and must not be
placed in the sterile field. A freeze indicator is placed inside the labeled carton. If the freeze
indicator has been activated, do not use the bioprosthesis.
The catheter is packaged in a double-pouch configuration and sterilized with ethylene oxide
gas. The catheter is sterile if the pouches are undamaged and unopened. The outer surfaces of
the outer pouch are nonsterile and must not be placed in the sterile field.
The CLS is packaged in a double-pouch configuration. The CLS is sterile if the pouches are
undamaged and unopened. The outer surfaces of the outer pouch are nonsterile and must not
be placed in the sterile field. The CLS is sterilized with ethylene oxide gas.
7.2 Storage
Store the bioprosthesis at room temperature. Avoid exposing to extreme fluctuations of
temperature. Avoid freezing. Appropriate inventory control should be maintained so that
bioprostheses with earlier Use By dates are implanted preferentially. Store the catheter and
CLS in a cool, dry environment.
16
8.0 Additional equipment
Note: While extensive, this equipment list is not meant to cover all possible scenarios.
Transesophogeal echocardiogram (TEE) or transthoracic echocardiography (TTE) on
standby
Temporary pacer insertion
• Temporary pacemaker catheter (4 Fr or 5 Fr), per hospital protocol
• Sterile sleeve for pacemaker catheter
• Hemostatic vessel introducer sheath
• Temporary pacemaker generator
• Sterile temporary pacemaker-to-generator cable
If indicated, pulmonary artery catheter insertion
• Standard pulmonary artery catheter
• Hemostatic vessel introducer sheath
• Saline flush line connected to pressure transducer
Baseline aortography via radial, brachial, or femoral approach
• 5 Fr or 6 Fr pigtail angiographic catheter
• 6 Fr hemostatic vessel introducer sheath
• 2-port manifold with saline flush line and pressure tubing or transducer
• Power injector syringe
• Contrast media
• High-pressure power injector tubing
Predilatation of implant site
• 2-port manifold with saline flush and transducer
• 9 Fr and 18 Fr hemostatic vessel introducer sheaths
• Standard length 0.035 in (0.889 mm) straight guidewire
• Appropriate suture-mediated closure system, if applicable
• Angiographic catheter
• 0.035 in (0.889 mm) × 260 cm standard high-support guidewire to be shaped with a
pigtail loop
• Balloon valvuloplasty catheters, ≤4 cm length × 18 mm, 20 mm, 22 mm or 23 mm, and
25 mm diameters
• Inflation device or syringe and diluted 1:5 contrast media
17
Bioprosthesis implantation
• 18 Fr hemostatic vessel introducer sheath
Standby supplies (must be available in the room)
• Pericardiocentesis tray
• 35 mm × 120 cm single loop snare
• Standard percutaneous coronary intervention (PCI) equipment
• 14 Fr and 16 Fr hemostatic vessel introducer sheaths
• Standard cardiac catheterization lab equipment
• Intra-aortic balloon pump (IABP)
18
9.0 Instructions for use
Figure 4
1. Catheter tip
2. Capsule
3. Catheter shaft
4. Tube flush port
5. AccuTrak™ stability layer
6. Macro slider
7. Micro knob
8. Luer-lock connection flush port
9.1 Inspection and bioprosthesis loading procedure
Caution: Once the bioprosthesis is removed from its container and the catheter and CLS are
removed from their packaging, ensure all subsequent procedures are performed in a sterile
field.
9.1.1 Inspection prior to use
1. Before removing the bioprosthesis, catheter, or CLS from its primary packaging,
carefully inspect the packaging for any evidence of damage that could compromise
the sterility or integrity of the device (e.g., cracked jar or lid, leakage, broken or
missing seals, torn or punctured pouch).
Caution: Do not use the product if there is evidence of damage.
2. Inspect the temperature indicator located within the packaging for the bioprosthesis to
ensure it has not been activated.
Caution: Do not use the bioprosthesis if the temperature indicator has been activated.
9.1.2 Preparation of the catheter
3. Wipe the length of the catheter with a moist (saline) gauze.
4. Use the micro knob and macro slider on the handle to open and close the catheter
(Figure 4).
19
5. Attach a stopcock to the first flush port. Attach a 10 mL syringe filled with saline to
the stopcock on the first flush port and flush. Repeat step for the second flush port on
the catheter (Figure 5).
Figure 5
6. Verify no catheter leakage is observed during any of the flushing steps. If leakage is
observed, use a new system.
7. Attach a 10 mL syringe filled with saline to the third flush port on the handle on the
catheter (Figure 6) and flush.
Figure 6
8. Fill a loading bath with cold, sterile saline (0°C to 8°C [32°F to 46°F]), and place the
CLS components in the bath.
9.1.3 Bioprosthesis rinsing procedure
9. Fill each of 3 rinsing bowls with approximately 500 mL of fresh, sterile saline at
ambient temperature (15°C to 25°C [59°F to 77°F]).
10. Confirm the integrity of the primary bioprosthesis container. Open the container and
remove the bioprosthesis by carefully grasping one of the frame loops. Let any
remaining solution drain from the bioprosthesis completely.
Caution: The bioprosthesis should not be handled or manipulated with sharp or
pointed objects. Use atraumatic blunt-tipped forceps only. Do not use the forceps to
grasp the tissue portion of the bioprosthesis.
Note: Retain the container with the original solution. It may be needed to store and
return a rejected bioprosthesis.
11. Compare the serial number on the container with the serial number on the tag
attached to the bioprosthesis.
Caution: If the serial numbers do not match, Do not use the bioprosthesis.
20
12. Carefully remove the serial number tag from the bioprosthesis and retain the tag.
Ensure that the suture that was used to secure the serial number tag to the
bioprosthesis is completely removed from the bioprosthesis.
13. Immerse the entire bioprosthesis in a sterile rinsing bowl.
14. Gently agitate the bioprosthesis by hand for 2 minutes to remove the glutaraldehyde
from the bioprosthesis.
15. Repeat steps 13 and 14 in each of the 2 remaining rinsing bowls to ensure complete
removal of glutaraldehyde from the bioprosthesis.
16. Leave the bioprosthesis submerged in sterile saline until it is ready to be loaded.
9.1.4 Bioprosthesis loading procedure
Caution: Rapid capsule advancement can contribute to difficulties with loading the valve.
Slowly advancing the capsule helps facilitate successful loading.
Caution: With the exception of attaching the bioprosthesis frame loops to the catheter tabs,
do not touch the capsule or the transition between the capsule and the catheter shaft. To
protect the capsule, handle the catheter using the catheter shaft or, during loading, the loading
tools.
Note: 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.
Perform the bioprosthesis loading procedure while the bioprosthesis, CLS, capsule, and
catheter tip are immersed in cold, sterile saline (0°C to 8°C [32°F to 46°F]).
17. To open the capsule, activate the macro slider and slide back.
18. Submerge and cool the bioprosthesis in a bath filled with cold, sterile saline.
19. Advance the outflow tube (tube with flared ends) over the catheter shaft toward the
handle (Figure 7).
Figure 7
20. Gently squeeze the outflow part of the cold bioprosthesis frame and insert it into the
outflow cone (Figure 8).
Note: As applicable, all subsequent bioprosthesis loading steps should be performed
under chilled (0°C to 8°C [32°F to 46°F]) saline.
21
Figure 8
21. Slowly continue to insert the frame into the outflow cone.
22. Once the bioprosthesis is fully inserted, secure the outflow cap onto the outflow cone
(Figure 9).
Figure 9
23. Carefully insert the inflow tube (straight tube) into the outflow cap (Figure 10).
Figure 10
24. Gently continue to advance the inflow tube until the bioprosthesis frame loops begin
to separate.
25. Insert the distal catheter tip into the inflow tube (Figure 11).
Figure 11
Note: The distal end of the catheter (Figure 11) may look slightly different from the
figures in Section 9.0. The functionality of the catheter is the same.
26. Carefully withdraw the inflow tube and attach the exposed frame loops to the catheter
tabs (Figure 12).
22
Figure 12
27. Rotate the micro knob to advance the capsule to cover the bioprosthesis frame loops
and the top of the outflow struts (Figure 13).
Note: Ensure that the capsule has covered all of the outflow struts and the
bioprosthesis frame loops are securely attached to the catheter tabs.
Figure 13
28. Advance the outflow tube over the radiopaque marker band of the capsule prior to
advancing the capsule further (Figure 14).
Figure 14
29. Remove the outflow cap and inflow tube from the outflow cone (Figure 15).
Figure 15
30. Move the outflow cone away from the bioprosthesis over the catheter toward the
handle.
31. Advance the inflow cone over the bioprosthesis using the outflow tube (Figure 16).
23
Figure 16
Note: Ensure the bioprosthesis frame axis is visually aligned (coaxial) with the inflow
cone axis during the insertion of the bioprosthesis into the inflow cone (Figure 17).
Complete the insertion of the bioprosthesis into the inflow cone in one uninterrupted
movement.
Figure 17
1. Inflow cone axis
2. Bioprosthesis frame axis
32. Continue to advance the bioprosthesis into the inflow cone until the outflow tube
contacts the inside of the inflow cone (Figure 18).
Figure 18
33. Visually inspect the bioprosthesis within the inflow cone to verify there is no crease
or infold in the frame beyond the second node from the inflow end. Ensure inspection
is performed circumferentially around the entire bioprosthesis.
Caution: If a crease or infold greater than 2 nodes long is noticed, do not use the
bioprosthesis or catheter. Prepare a new bioprosthesis to load into a new catheter.
24
Figure 19
Figure 20
34. Hold the inflow cone against the outflow tube while slowly advancing the capsule
over the bioprosthesis until the capsule comes within approximately 5 mm of the
catheter tip (Figure 21). If the micro knob clicks, apply upward pressure to the macro
slider and continue turning the micro knob (Figure 22).
Figure 21 Figure 22
35. With the catheter tip submerged in cold saline, flush both tube flush ports with saline.
36. Slowly advance the capsule over the bioprosthesis until the capsule contacts the
catheter tip.
37. If the micro knob has fully advanced the capsule and a small gap remains between the
end of the capsule and the catheter tip, stabilize the handle with one hand; position the
other hand on the blue catheter shaft and gently advance the capsule manually to
close the gap between the capsule and the catheter tip (Figure 23).
Figure 23
38. Remove the outflow cone and outflow tube from the catheter (Figure 24).
Figure 24
25
39. Conduct a final visual inspection of the loaded bioprosthesis to make sure the frame is
free of creases or infolds beyond the second node from the inflow end. Ensure
inspection is performed circumferentially around the entire bioprosthesis.
Caution: If a crease or infold greater than 2 nodes long is noticed, do not use the
bioprosthesis or catheter. Prepare a new bioprosthesis to load into a new catheter.
Figure 25
40. Leave the loaded bioprosthesis submerged in cold saline until implantation.
Figure 26
9.2 Bioprosthesis implantation
9.2.1 Vascular access
Note: Vascular access should be achieved per hospital protocol (either percutaneously or via
surgical cutdown).
Note: The primary access artery will be used to introduce the CoreValve™ system and, if
predilatation is performed, the balloon catheter; the secondary access artery will be used to
introduce the reference pigtail.
1. Establish a central venous line. Insert a 4 Fr or 5 Fr temporary pacemaker catheter via
the right internal jugular vein (or other appropriate access vessel) per hospital
protocol.
2. Insert a 6 Fr introducer sheath into the secondary access artery.
3. Insert an 18 Fr introducer sheath into the primary access artery.
4. Administer anticoagulant according to hospital protocol. If heparin is administered as
an anticoagulant, check the activated clotting time (ACT) after initial bolus of heparin
and recheck every 30 minutes thereafter. Maintain ACT ≥250 seconds.
Note: Anticoagulant may be administered at any time prior to this point, but avoid
delaying beyond this point.
9.2.2 Crossing the valve
5. Advance the graduated pigtail catheter to the ascending aorta and position the distal
tip in the noncoronary cusp of the aortic valve.
6. Identify the ideal annular viewing plane using contrast injections at various
angiographic angles.
Note: It is recommended that a dedicated individual prepare and operate the contrast
injector.
26
7. Insert an angiographic catheter over a standard J-tip guidewire into the primary access
sheath and advance to the ascending aorta.
8. Exchange the J-tip guidewire for a 0.035 in (0.889 mm) straight-tip guidewire.
Advance the straight-tip guidewire across the aortic valve into the left ventricle (LV).
9. After crossing the aortic valve with the guidewire, advance the angiographic catheter
into the LV.
10. Exchange the straight-tip guidewire for an exchange-length J-tip guidewire.
11. Exchange the angiographic catheter for a 6 Fr pigtail catheter.
12. Remove the guidewire and connect the catheter to the transducer. Using both
catheters, record the aortic pressure gradient.
13. Using a right anterior oblique (RAO) projection, advance the previously pigtail-
shaped, 0.035 in (0.889 mm) high-support guidewire through the pigtail catheter and
position in the apex of the LV.
14. Remove the pigtail catheter while maintaining guidewire position in the LV.
9.2.3 Predilatation of the implant site
Note: The need for predilatation of the native valve is determined by the heart team.
Information for failed surgical bioprostheses: Balloon predilatation of a stenotic surgical
aortic bioprosthesis has not been evaluated. In cases where there is severe stenosis,
predilatation of the surgical aortic bioprosthesis may be done at the discretion of the heart
team and the steps used are identical to native valve predilatation.
15. Insert the valvuloplasty balloon through the 18 Fr introducer sheath and advance it to
the ascending aorta.
16. Reposition the angiographic equipment to the ideal viewing plane. Position the
valvuloplasty balloon across the valve, while maintaining strict fluoroscopic
surveillance of the distal tip of the guidewire in the LV.
17. Perform balloon valvuloplasty per hospital protocol and remove the valvuloplasty
balloon while maintaining guidewire position across the aortic valve.
9.2.4 Deployment
18. Insert the device over the 0.035 in (0.889 mm) guidewire and into the introducer
sheath with the macro slider facing upward. Advance the device while maintaining
strict fluoroscopic surveillance of the guidewire in the LV.
19. When crossing the aortic arch, it is critical that the guidewire is controlled to prevent
it from moving forward. Without proper management of the distal tip of the
guidewire, the guidewire could move forward and cause trauma to the LV.
20. Advance the device through the valve. Perform an angiogram to confirm that the
pigtail catheter is in position within the noncoronary cusp of the aortic root.
Fluoroscopically identify the appropriate landmarks.
27
Figure 27
21. Note the radiopaque bands (Figure 28). Follow the diagrams in Figure 29 and
Figure 32 for the optimal placement of the bioprosthesis. The bioprosthesis should be
placed so that the skirt is within the aortic annulus (approximately 4 mm to 6 mm
below the annulus). In native anatomy, the annulus is defined as the angiographic
floor of the aortic root. For surgical bioprostheses, consider the features of the valve
when determining the optimal placement.
Figure 28 Figure 29
22. After attaining optimal catheter position, slowly turn the micro knob and begin to
deploy the bioprosthesis. As the inflow aspect of the bioprosthesis starts to flare
outward, monitor bioprosthesis position under fluoroscopy.
Caution: During implantation, if resistance to deployment is encountered (e.g., the
micro knob starts clicking or is tight or stuck), apply mild upward pressure to the
macro slider while turning the micro knob (Figure 22). If the bioprosthesis still does
not deploy, remove it from the patient and use another system.
Figure 30
23. Perform an angiogram. Once annular contact is made, the bioprosthesis should not be
advanced into a lower position.
28
Loading...