Mitral Clips: History, Risks, Benefits, and Overview

Lee Whitt: R.T. student

Learning Objectives

1. Understand the structure and function of the mitral valve.

2. What mitral regurgitation and how does it affect patients?
3. What is the history of treating mitral regurgitation?
4. What is the history of the MitraClip?
5. What does the MitraClip accomplish?
6. How does the MitraClip compare to the mitral valve replacement?
7. What is the role of the MitraClip procedure today?
8. How does the procedure take place?
9. What is the technologist’s role in this procedure?

Abstract
Mitral valve insufficiency is a serious and potentially life threatening condition. It is a
common condition with approximately 1.7% of the United States population suffers from some
form of mitral valve disorder.1 When the mitral valve is incontinent blood will regurgitate from
the left ventricle back into the left atrium causing shortness of breath, atrial fibrillation, fatigue,
and lightheadedness. Mitral clipping a treatment technique that involves attaching the weak
leaflets in the mitral valve. It is a relatively new technique. In 2003 the first successful attempt
was done on pigs and now it is done with great success on patients around the country.

Introduction
The mitral valve or bicuspid valve sits between the left atrium and ventricle. It is made
up of two leaflets that open to allow blood to flow from the left atrium to the left ventricle and
that close on ventricular contraction to prevent blood backflow from the left ventricle back into
the left atrium. The leaflets are surrounded by the muscular annulus that provides structure for
the leaflets. They are supported underneath by chordae tendinae. Chordae tendinae are small
string like structures that are attached to the back of the mitral valve leaflets which are supported
by the papillary muscles. The papillary muscles attach to the back of the chordae tendinae and
anchor them to the wall of the ventricle. (Figure 3) If any of these structures are underdeveloped
or damaged it leads to mitral valve insufficiency. When the ventricle contracts blood is flowing
in two directions, into the aorta (as it should) and back into the right atrium. This is known as
mitral valve regurgitation. This increases pressure in the ventricle and propagates into the right
atrium and into the pulmonary veins. Increased pressure in the pulmonary veins can cause fluid
to accumulate in the lungs, a condition known as pulmonary edema.

Pulmonary edema is not the only symptom that comes from mitral valve insufficiency.
Increased blood volume in the left atrium over time causes the enlargement of the chamber. Left
atrial enlargement can lead to irregular and fast heartbeats, a condition known as atrial
fibrillation. Atrial fibrillation causes the atrium to quiver and shake but not fully contract. This
causes blood to pool in the atrium and puts the patient at risk for blood clots that can lead to
stroke.4

If the mitral regurgitation is severe enough it can lead to cardiomegaly.4 Cardiac output
is low because not all of the blood in the left ventricle is being ejected into the body. The heart
has to work harder to push enough blood out to the body causing it to grow in size. When the
enlarged heart can no longer meet the oxygen demands of the body the patient enters into heart
failure. Patients suffering from heart failure experience systemic edema-- shortness of breath. If
the problem persists, damage done to the heart muscle cannot be reversed and the only treatment
is symptom management and heart transplant.

HISTORY
Clearly mitral valve regurgitation is a serious problem. Luckily for patients living today,
new treatment options provide a better outlook. Any kind of mitral valve repair are relatively
new procedures. The mechanical heart and lung machine was invented in 19532 and allowed
surgeons to develop open heart surgery techniques that would revolutionize heart care. Some of
these techniques were mitral and aortic valve replacements.

The first mechanical mitral valve replacement was completed in 1960 and the first valve
replacement from a human patient was successfully performed in 1962.2 The first mechanical
valve replacement in 1960 was ground breaking but the foreign object in the patient’s body
would constantly form clots that would cause pulmonary embolism or myocardial infarction.
The material that it was created from was not coated with any sort of anticoagulant medicine
because at that time there was no coating that could be placed on the valve that would remain
long enough to benefit the patient. The patient had to remain on anticoagulant drugs for the rest
of his life to stop the deadly clots from forming. A patient can live on anticoagulants for the rest
of their life but it has major risks. The patient has to be careful not to get any cuts because they
could potentially bleed out and die if the cut was serious enough. If they have any sort of
internal bleeding from an ulcer, surgery, varices, or any other abnormality it becomes life
threatening.

This dilemma is present for any device that is going to be implanted in the body. This
includes valves, stents, clips, closure devices and many more. Technology involving the implants
has allowed them to remain in the body for a longer period of time. As you can see valve
replacement has developed immensely and it is a viable option for people suffering from mitral
valve regurgitation. This surgery has had a lot of success and is done fairly routinely but it is
still an invasive procedure. Open heart surgery is always a high risk procedure, especially in the
case of elderly patients, patients who are further along in their heart failure,
immunocompromised patients, and any other patient with a serious preexisting condition. New
mitral clip technology is a much less invasive procedure that allows for mitral valve repair using
the trans-catheter method, allowing physicians to forgo opening the patient’s chest.

Mitral valve clipping is a significantly newer technique than open heart valve replacement
surgery. The first mitral clip was performed on a pig fifteen years ago in 2003. Since then the
technique has changed drastically and has become the lifeline for high risk patients who
otherwise would have no option.

The MitraClip is a small device that is used to attach the anterior and posterior leaflets of the
mitral valve together increasing coaption of the leaflets and ultimately reducing the amount of
blood that regurgitates from the left ventricle back into the left atrium. The principle behind this
technique is remarkably simple, but the details of the procedure are a little more complex.

The first method of introducing a MitraClip was performed on pigs. This method consisted
of introducing a 24 french guide catheter and a trans-septal wire into the left femoral vein of the
animal. The catheter was advanced into the right atrium and then the trans septal needle was
advanced through the guide catheter. The needle then punctured the septal wall allowing access
into the left atrium. The MitraClip was then introduced into the left atrium in a closed state. The
closed clip is made of cobalt-chromium and is covered in polyester to reduce clot formation on
the device. When closed the clip measured 4 mm in width and when fully open the clip
measured up to 20 mm.

Once in the left ventricle, the clip is adjusted using fluoroscopic imaging until the arms of the
clip are perpendicular to the leaflets of the mitral valve. When the physician confirms the
placement of the clip it is advanced through the mitral valve and into the left ventricle. The
position of the clip is re-evaluated to make sure that when the flaps of the mitral valve are open
they will not touch the clip. The clip is then opened in the left ventricle and is retracted into the
mitral valve on systole. The clip then snares each of the valve leaflets and is pulled closed. 5 The
clip can be reopened and closed as many times as needed to ensure that the clip is actually seated
properly. Once the doctor is satisfied with the connection and position on the leaflets the clip is
disconnected from its deployment device and the intervention is completed.

The aforementioned study used a sample of 14 pigs. Of these 12 pigs had a successful
operation. The clips placed in the other two pigs failed to grasp the anterior leaflet of the mitral
valve. This was due to an incomplete opening of the mitral clips because of poor positioning.
None of the pigs had damage to other structures in the heart and it was deemed safe and
reasonable to continue the study of mitral clips.5

A second study on a sample of 21 pigs was later completed but this time a direct arterial
approach was utilized. This technique is superior to a venous approach because it allows the
device to be delivered into the left ventricle from the aorta. The delivery catheter is passed from
the femoral artery through the abdominal aorta, the descending aorta, then around the aortic arch,
through the aortic valve and finally into the left ventricle. This eliminates the need for a trans-
septal needle and decreases the chance of cardiac damage.

This more direct approach yielded more success. All twenty-one of the pigs had a successful
procedure. Further study revealed upon autopsy 20 of the 21 pigs that underwent the procedure
had a double-orifice valve and 19 of the 21 pigs had developed endotheliazation around the
device. The two that did not show endotheliazation around the device developed endocarditis
and had to be euthanized early.5
 Endotheliazation simply means the formation of endothelial tissue. This is imperative for the
long term success of the device. As previously discussed the formation of blood clots is one of
the main concerns when implanting anything into the heart. Any hardware that is inserted into
the body and left there must be covered with antithrombotic drugs in order to prevent the
formation of deadly blood clots in the body. Once endotheliazation occurs the device will be
covered in endothelial tissue created by the body and it will not be exposed to the bloodstream
therefore clots can no longer be formed on it.

The overwhelming success in animal trials lead to the US Food and Drug Administration
(FDA) approving a human trial of mitral clip devices. This trial was called EVEREST I
(Endovascular Valve Edge to Edge Repair Study).6 The sample of the study was 27 patients
suffering from moderate to severe mitral regurgitation. Of the 27 participants 22 patients left the
hospital with clips in place. Three of the five patients that did not leave with clips in place had
them removed because the mitral clip did not adequately reduce the mitral valve regurgitation
and then underwent mitral valve replacement. The other two patients had to undergo mitral
valve replacement because of device malfunction. Of the 22 other patients, 14 showed decreased
mitral-valve regurgitation after one month and 13 maintained decreased regurgitation after six
months. 18 of the 22 patients that had MitraClips placed had avoided having mitral valve
replacement for six months.

While these results seemed promising there was a fair number of adverse events. Of the 22
patients with MitraClips placed, one patient had a stroke within thirty days and three patients
experienced detachment of the clip from one of the mitral leaflets. The stroke cannot be directly
attributed to the MitraClip placement but it is possible that it at least contributed to the clot
formation that ultimately caused the stroke. It is also possible that this stroke would have
happened without the placement of the MitraClip. If the MitraClips were causing clot formation
in the body it is likely that more than one of the patients would have experienced adverse effects
caused by a blood clot.

The results of this study were positive enough to warrant a follow up study with a larger
sample size. EVEREST II6 included 107 subjects. All of the subjects underwent the MitraClip
procedure. In 74% of patients, the MitraClip was successfully placed. Hemodynamic stability
was noted for all of the participants and symptomatic improvement was seen in 74% of the
population with the MitraClip. It is important to note that out of 107 participants 32 had to have
a mitral valve replacement after a failed mitral clip. This is an important finding for two reasons.
First, it shows that the mitral clip is far from the perfect solution for patients suffering from
mitral regurgitation. Secondly, it proved that having the procedure did not impede the success of
a mitral valve replacement if the clip did not perform adequately. At this point in the
development of MitraClip, mitral valve replacement still showed superior results. The fact that
the MitraClip was having considerable success and not hurting the possibility of completing
mitral valve replacement in the future was intriguing to many doctors because the MitraClip
procedure was less risky to the patient’s health and recovery times were significantly faster.

The EVEREST studies were closely followed in medical circles. In 2009 a review of the
EVEREST studies revealed that the procedure times for the MitraClip placement had decreased
from 231 minutes to 90 minutes over the course of the study. This is due to developing
procedure methods. When the study first started physicians used the tran-septal approach. After
numerous attempts at placing the valve they realized that the guidewire removal method was
faster and more effective.

The first trial specifically comparing the MitraClip device and mitral valve replacement
took place in 2011.5,9 279 patients were selected for this study. All of the patients in the sample
suffered from severe to moderate mitral valve regurgitation. The patients were randomly
selected to undergo either the MitraClip procedure or a mitral valve replacement at a 2:1 ratio.
Twelve months after the patients received treatment 55% of patients who received the MitraClip
procedure were free of death, surgery, and mitral valve regurgitation. This is compared to 73%
rate in patients receiving mitral valve replacement. Twenty percent of patients who underwent
the MitraClip procedure had to be operated on again to either replace the mitral valve or reattach
the clip to the leaflets. Only two percent of patients undergoing mitral valve replacement had to
be operated on again.

ANALYSIS
It is clear after all of these trials that mitral valve replacement is a more effective
treatment for mitral regurgitation. MitraClips, on the other hand still have overall positive results
on the patients and is a quicker and considerably safer procedure. In the 2011 study forty-eight
percent of patients undergoing mitral valve replacement experienced a major adverse event
during surgery. The definition of the major adverse events included having to transfuse at least
two liters of blood. Patients undergoing the MitraClip procedure only had a 15% instance of a
major adverse event during the procedure.

It is important to note the significance of the major adverse events reported in the 2011
study. While any major adverse event is serious, the statistic concerning the danger of mitral
valve replacement can be misleading. The transfusion of at least two liters of blood accounted
for the vast majority of the major adverse events reported. While having to transfuse that amount
of blood in a procedure is noteworthy, it is not uncommon in any open heart procedure and does
not typically impact the outcome of recovery rate of patients.

Another factor considered in the EVEREST II study was cost effectiveness.11 The cost of
the MitraClip procedure in the U.S. was averaged at $18,000. This figure is significantly less
expensive than the average mitral valve replacement procedure. Patients on average were paying
$2,200 less per procedure. This is a significant amount of money. For some patients the lower
cost and the less invasive procedure may sway them towards having a MitraClip procedure
instead of the mitral valve replacement even though replacement has demonstrated better
outcomes.

Unfortunately, this was not the only finding when evaluating price of the procedures.
The approximate price of a MitraClip procedure in the UK was $26,200. This is $6,292 more
than the price of the mitral valve repair. The variability in price brings into question the price
point in the United States. Markets constantly fluctuate and this is evidence of the possibility of
an eventual increase in price in the United States. This small study is neither a large enough
sample nor does it give convincing evidence that the MitraClip procedure is more cost-effective
than mitral valve replacement.

MitraClip is not the apparent answer to transform how we treat patients with mitral valve
insufficiency. There are multiple issues with the device and procedure that do not make it the
clear cut choice for treating the condition. The limited scope of the MitraClip procedure is one of
the main reasons that mitral valve replacement is still necessary and preferred. Faulty leaflets are
not the only issue when treating the valve. The annulus surrounding the valve in many cases is
unstable and the MitraClip device does not have the ability to treat this aspect of the condition.
This in turn changes the shape of the leaflets causing a deficiency of coaption between the
anterior and posterior leaflets. Mitral valve stenosis is another form of valvular disease that
cannot be corrected using the MitraClip device. The chordae tendinae can also be impaired
causing valvular insufficiency. The chordae tendinae are the string-like structures that anchor
the mitral leaflets to the papillary muscles and then to the ventricle wall. If these rupture when
the leaflets close on systole, the portions that used to be anchored to the ventricle wall now will
retract back through the annulus reducing or eliminating coaption between the leaflets. This
allows blood to eject back into the left atrium instead of out into the aorta.

Mitral valve repair allows the physician to repair many different forms of mitral valve
disease. The annulus of surrounding the mitral valve can change shape over time due to the
enlargement of the heart or increased pressure on the valve from the repeated backflow of blood
caused by deteriorated leaflets. Annuloplasty is one open heart procedure that allows the doctor
to place a ring around the annulus of the mitral valve, reshaping it so that the valve can return to
normal function. Chordal repair is another option that is available to patients in mitral valve
replacement that is not possible using the MitraClip

The limitations of the MitraClip procedure are evident but that does not meant that is not
a clinically viable option for some patients. As previously mentioned, open heart surgery is a
serious procedure. It is so invasive that it is simply not an option for some patients. A study
done at the University of Virginia in the Division of Thoracic and Cardiovascular Surgery1
proved that the MitraClip procedure was a viable option for patients who were too high risk for
open heart surgery. This study consisted of 115 high risk surgical candidates. These patients
had a predicted mean mortality risk of 9.4% with a standard deviation of 6.4%. All of these
patients had the MitraClip procedure done at the University hospital anywhere from 2009-2014.
67.8% of patients had coronary artery disease, 39.1% had pulmonary disease, and 44.3% had
previous cardiac surgery. The results were overwhelmingly positive. The device was placed
successfully in all 115 patients. 79% of patients were exhibiting class III or IV symptoms when
they arrived to the hospital and 81% of patients reported trace to class I symptoms upon
discharge.

The positive outcomes of this procedure in the different studies have led to the FDA’s
approval of the MitraClip device for the use in patients with symptomatic, degenerative mitral
regurgitation grade III or IV who are high risk for surgery. This is great news for all high risk
surgery patients. Recent developments have shown promise in placing more than one clip on the
leaflets. This is beneficial because it provides a tighter grip on the mitral valve leaflets,
decreasing the likelihood that the clip will detach from the valve. If one clip does detach from
the valve the double orifice valve is still maintained

PROCEDURE
The MitraClip procedure varies with every case. No one patient has the same anatomy
and the case will always be carried out differently. A normal mitral valve’s leaflets when closed
have a coaption area of about 10mm and they both sit below the annulus. Some mitral valves
have one leaflet that is normal and the other is retracted back above the annulus. This is called a
prolapse leaflet because even though the middle segment of the leaflet is retracted above the
annulus, the tip of the leaflet is still pointed down towards the left ventricle. A flail leaflet is
another common abnormality associated with mitral regurgitation. This deformity is
characterized by the tip of one of the leaflets pointed back up through the annulus of the valve.
This is caused by chordal rupture. (Figure 1)

The specifics of the valvular deformities have to be understood for a successful procedure
to take place. Before the procedure the doctors must work with imaging staff to understand
exactly what they are dealing with before they begin the procedure. Physicians work with CT
technologists, MRI technologists, and echocardiography techs in order to create a visual of the
valve before they begin the procedure. This way a plan can be devised with other doctors and
communicated to the staff.

The differences in anatomy and the fact that the patients are at high for a cardiac event
makes a team approach to placing the clips imperative. The doctors need to work closely with
the nurses, imaging staff, and the anesthesia team to create a plan that is catered to each patient.
Another reason that the staff need to be on the same page is that all patients receiving mitral clips
have high mortality risks for open heart surgery. Most of these patients are fragile to begin with
and many things can go wrong at any given time. If there is a problem during the procedure,
time is of the essence and everyone involved needs to know what to do and what to anticipate.

The procedure has a lot of moving parts. For all of MitraClip procedures trans-
esophageal echocardiography (TEE) is utilized to visualize the valve and help deliver the
equipment. TEE is a form of ultrasound. Unlike a normal echocardiogram the ultrasound probe
is passed through the mouth and into the esophagus. This is beneficial because the probe is
positioned so close to the heart that the structure of the chambers and valves can be visualized.
The patient has to be sedated for this because a conscious patient cannot tolerate the probe in the
esophagus. This part of the procedure makes it necessary for general anesthesia staff and
echocardiography techs to be present during the procedure. Fluoroscopy is also used to guide the
clips into place. The role of radiation technologists or cardiovascular techs includes operating
the fluoroscopy equipment, performing surgical assisting, monitoring, and documenting. The
nurse’s role includes monitoring the patients, pushing medications, and documenting. The
physician is responsible for performing the procedure, monitoring vital signs, consulting with the
families, and devising a plan for the procedure. There are many different staff in the procedure
but ultimately the physician is responsible for the outcome of the procedure.

The MitraClip procedure has developed since it was first attempted in pigs. The new
process has had greater success but that is in part because of the refinement of the process. The
procedure now is extremely detailed and steps are taken to avoid mistakes that have happened in
the past. With each step there are checks to make sure that everything is correct before moving
to the next step and potentially causing a problem.

The first step in the procedure10 is access. Access is always done in the femoral vein
because the steerable guide catheter is 24 French or a 25.13 mm diameter. This is the only safe
access site for equipment this large. The area is numbed with lidocaine then the six French
sheath is inserted into the vein. Different size dilators are introduced into the vein gauging up
the size until you reach the 24 French sheath. The guide catheter is passed through the sheath
into the right atrium.

Next the trans-septal needle is passed through the guide catheter into the right atrium and
positioned against the interatrial septum. The puncture should be made four to five centimeters
above the coaption plane of the mitral leaflets. It is imperative to use both TEE and fluoroscopy
to make sure that the angle and position of the needle are correct before puncture. If the
puncture is less than 4-5 centimeters above the plane of coaption it limits the maneuverability of
the clip and increases the risk of severing the chordae tendinae once the clip has been advanced
into the left ventricle. Once the positioning has been confirmed the needle is advanced into the
intra-arterial septum and through into the left atrium. This step is done under continuous TEE
and fluoroscopy. If the trajectory of the needle is towards the aortic root or the posterior wall of
the left atrium the physician should be notified immediately.

After the intra-atrial septum is punctured the sheath is passed over the trans-septal needle.
The needle is removed and the guide wire is placed in the pulmonary veins. The steerable guide
catheter and dilator is advanced over the guidewire under TEE and fluoroscopic watch until it is
2cm into the left atrium. The radiopaque markers on the end of the guide catheter allow you to
measure the distance that it has been inserted. Once the catheter’s position has been confirmed
using the imaging the dilator and guidewire are pulled back out of the patient.

The clip delivery system is then passed through the guide catheter into left atrium. If
patients have a small left atrium or the tip of the clip delivery system comes in contact with the
left atrial wall the system needs to be retracted in order to avoid perforation. Once in the left
atrium TEE allows the physician to align the clip perpendicularly with the line of coaption
between the leaflets.

With the clip open and in position it can be advanced into the left ventricle. It is
important to note that when it’s being advanced through the mitral valve it can easily shift and
rotate. This is why it is important to perform this step under continuous TEE and fluoroscopy.
When in the left ventricle its orientation of the clip must be reconfirmed. If it is no longer in the
correct position it should not be maneuvered extensively in the left ventricle to avoid damaging
the chordae tendinae and the papillary muscles. If repositioning must occur the clip arms can be
closed and the device retracted back into the left atrium to be repositioned.

After positioning is confirmed in the left ventricle the clip delivery system is retracted
until the clip arms are resting beneath the mitral valve leaflets. Leaflet capture can be the most
challenging part of the procedure, especially in patients with a sever coaption defect like flail
leaflet. There are several maneuvers for the different types of mitral valve coaption defects.
Once the leaflets are solidly on the clip arms the grippers can be lowered onto the leaflets,
closing the clip. Mitral regurgitation should then be measured and the clip delivery system can
be released. It is important to note that the mitral regurgitation can change from the time that the
clip closes and the time that the clip delivery system is removed. If the mitral regurgitation
worsens after the delivery system is removed then it may be necessary to place one or two more
clips.

The role of the technologist is of great importance during these procedures. Whenever
you are doing a catheterization procedure the physician cannot see what she or he is working on
without the assistance of fluoroscopy. On procedures as involved as this technologist
competency and accuracy is imperative. The technologist needs to know what to be looking for
at each step in the procedure. For example, when the clip delivery system is being passed
through the septal wall into the left atrium the technologist has to know to include the whole left
atrium in the frame to make sure that the delivery system does not come into contact with the
wall. If the required anatomy is not in the frame the physician could perforate the atrial wall and
not be aware of it.

The technologist is also responsible for prepping all of the equipment and monitoring the
hemodynamic status of the patients. This is an extremely important role during a procedure of
this magnitude. The equipment must be prepped properly in order to function correctly. If you
don’t flush each piece carefully, making sure that there is no air in the catheters or lines, air can
be introduced into the body and cause the patient to have a heart attack. Monitoring is an equally
important role because the physician has to be focused on the equipment and the many steps of
performing the procedure. Their eyes cannot always be watching the vital signs. If a change in
rhythm or pressure occurs they need to be notified immediately to see what action needs to be
taken. Everything can appear normal on the fluoroscopy screen, which is where most everyone’s
eyes are fixed while the vitals monitor is showing that the patient is experiencing a cardiac event.

The final responsibility of the technologist is to document. This is a difficult job during
MitraClip procedures because there is so much equipment and so many steps. The technologist
must document who is in the room and step by step what is happening. From the timeout until
the patient is out of the room every step is documented. The technologist must document each
piece of equipment that is used and the amount of contrast. It is imperative to get each of these
steps and all of the equipment correct for legal purposes. If something goes wrong during the
procedure and the log does not make match the events that occurred in the case, the hospital is
liable. If the hospital is sued the log should be able to verify everything that happened in the
case. Good documentation is the best defense for medico-legal defense.

Conclusion
MitraClip is new to Cardiac Catheterization, but it is here to stay. It is a beneficial option
and many times the only option for patients who are at too high a risk for open heart surgery.
While the patient outcomes aren’t as consistently positive as valve replacement it is still a viable
option. The benefits are clear: non-invasive, fast recovery times, and good success rates. The
success rates of the procedure will only improve and the research done for the MitraClip device
is helping to lay the foundations for new procedures to come. This new technology is an
example of the expanding and bright future of cardiac catheterization. More and more
procedures will be done through catheterization as the techniques and technology improve. Non-
invasive cardiology has great promise of decreasing cost and improving patient outcomes.
MitraClip is a great example but not the only example of how this trend is already in motion.

Author Bibliography

My name is Kenneth Lee Whitt and I am a senior student in the Radiologic Science
department at the University of North Carolina at Chapel Hill. I plan on certifying in
radiography and cardiac catheterization. I have completed my clinical rotations in cardiac cath at
the University of North Carolina Hospital and Wake Med Medical Center. I believe that staff
education is an imperative aspect of patient care and I strive to continue my education on the
field of radiology beyond my bachelor’s degree.
(Figure 1) Mitral Valve Defects:

(From left to right: A) shows a normal mitral valve: total coaption between leaflets and the
entirety of the leaflets sit below the annulus. B) Mitral valve prolapse: The middle portion of
the leaflet protrudes through the annulus but the distal end of the leaflet points down towards the
left ventricle. C) Flail Leaflet- caused by chordal rupture. Distal end of the leaflet extends
through the annulus of the valve. D) Functional MR. Leaflets remain beneath the annulus but the
annulus is widened decreasing coaption of the leaflets causing the mitral regurgitation.)
(Figure 2) MitraClip Device:

(All of the portions of the MitraClip device are visualized and shown in procedure. Final
product of the procedure visualized)
(Figure 3) Mitral Valve Anatomy:

(Structure of the mitral valve in view. Includes anterior and posterior leaflets, annulus, chordae
tendinae, and papillary muscles)
Questions:

1. The mitral valve defect that is characterized by a chordal rupture is known as

a. Functional Regurgitation
b. Flail leaflet
c. Prolapsed leaflet
d. Annular stretching
2. Which of the following patients would benefit most from the MitraClip procedure.
a. Patient with a flail leaflet.
b. Patient with a prolapsed leaflet
c. Patient with severe coronary artery disease
d. 27 year old with moderate mitral regurgitation
3. What size guide catheter is used for the MitraClip procedure?
a. 6fr.
b. 27fr.
c. 12fr.
d. 24fr.
4. After a successful clip placement if mitral regurgitation still persists what is the best
course of action?
a. Schedule mitral valve replacement
b. Place another clip
c. Take the clip off and try to reattach it
d. Treat with medication
5. What anatomy is most important to include in fluoroscopy when the clip delivery device
is being advanced into place?
a. Left atrial wall
b. Pulmonary veins
c. Ventricular apex
d. Superior Venae Cava
6. What is the orientation of the MitraClip in relation to the valve leaflets.
a. Parallel to the leaflets
b. 25 degree angle to the leaflets
 c. Flush with the anterior leaflet
d. Perpendicular to the leaflets.
7. What was EVEREST I
a. The first animal trial using MitraClip
b. The second animal trial using MitraClip.
c. The first human trial using MitraClip
d. The second human trial using MitraClip
8. What is necessary for the long term prevention of blood clots forming on the device?
a. Endotheliazation
b. Antithrombotic medications
c. Antithrombotic drug coatings
d. Correct device placement
9. What is the name given to the structure created by using the MitraClip?
a. Normal Valve
b. Single orifice valve
c. Double orifice valve
d. Triple orifice valve
10. What is the significance of the study done at the University of Virginia?
a. It provided further evidence that the MitraClip device is a viable option for high
risk surgical patients.
b. It proved that the MitraClip procedure is cheaper than surgical repair.
c. It proved that the MitraClip procedure is more expensive than surgical repair.
d. It proved that mitral valve replacement is superior to MitraClip.
Bibliography

1. Problem: Mitral Valve Regurgitation. Available at:

http://www.heart.org/HEARTORG/Conditions/More/HeartValveProblemsandDisease/Pr
oblem-Mitral-Valve-Regurgitation_UCM_450612_Article.jsp#.WrGtOJcpCM8.
Accessed March 21, 2018.
2. Development of heart valve surgery. Available at: https://www.bhf.org.uk/heart-matters-
magazine/my-story/john-fitzsimmins/development-of-valve-surgery. Accessed March 21,
2018.
3. Downs EA, Lim DS, Saji M, Ailawadi G. Current state of transcatheter mitral valve
repair with the MitraClip. Ann. Cardiothorac. Surg. 2015;4(4):335-340.
doi:10.3978/j.issn.2225-319X.2015.02.02.
4. Heart Failure. Available at:
http://www.heart.org/HEARTORG/Conditions/HeartFailure/Heart-
Failure_UCM_002019_SubHomePage.jsp. Accessed March 21, 2018.
5. Magruder JT, Crawford TC, Grimm JC, Fredi JL, Shah AS. Managing mitral
regurgitation: focus on the MitraClip device. Med Devices (Auckl) 2016;9:53-60.
doi:10.2147/MDER.S86645.
6. Feldman T, Wasserman H.S, Herrmann H.C, et al. Percutaneous mitral valve repair using
edge-to-edge technique; six month results of the EVEREST Phase I Clinical Trial. J Am
Coll Cardiol. 2005; 46(11):2134-2140
7. Feldman T, Kar S, Rinaldi M, et al. Percutaneous mitral repair with the Mitra Clip
system; safety and midterm durability in the initial EVEREST (Endovascular Valve
Edge-to Edge Repair Study) cohort. J Am Coll Cardiol. 2009;54(8):686-694
8. Mauri L, Garg P, Massaro JM, et al. The EVEREST II Trial; design and rationale for a
randomized study of the evalve MitraClip system compared with mitral valve surgery for
mitral regurgitation. Am Heart J. 2010;160(1):23-2
9. Reynolds M, Galper B, Apruzzese P, et al. TCT-786 Cost Effectiveness of the
MitraClip® Compared with Mitral Valve Surgery: 12-month Results from the EVEREST
II Randomized Controlled Trial. J. Am. Coll. Cardiol. 2012;60(17):B229.
doi:10.1016/j.jacc.2012.08.831.
10. Nyman CB, Mackensen GB, Jelacic S, Little SH, Smith TW, Mahmood F. Transcatheter
Mitral Valve Repair Using the Edge-to-Edge Clip. J. Am. Soc. Echocardiogr.
2018;31(4):434-453. doi:10.1016/j.echo.2018.01.012.
11. Fanari Z, Weintraub WS. Cost-effectiveness of transcatheter versus surgical management
of structural heart disease. Cardiovasc. Revasc. Med. 2016;17(1):44-47.
doi:10.1016/j.carrev.2015.08.011.