You Are Not AloneYou Are Not Alone700,000

Yearly there are 700,000 heart surgeries performed across the world• 250,000 of them are valve surgeries• Heart valve surgery has been shown to be safe and has a low

mortality rate (2.4%)mortality rate (2.4%)• Safer in less symptomatic patients• Safer in high volume centers

Some valve surgery patients you may know:Some valve surgery patients you may know:• Barbara Walters, Barbara Bush, Robin Williams, Liz Taylor, Arnold

Schwarzenegger, and more

1. The Patient’s Guide to Heart Valve Surgery, by Adam Pick

Why Minimal Incision Valve Surgery?Why Minimal Incision Valve Surgery?

A decade worth of clinical data shows that minimalA decade worth of clinical data shows that minimal incision or minimally invasive valve surgery (MIVS) can achieve great results, comparable to open chest valve surgery. MIVS also includes these additional benefits2:

• Less trauma and physical impact to the body• Less trauma and physical impact to the body• Faster recovery and return to normal activities• Less scarring and improved cosmetic results• Reduced blood loss and risk of post-operative complications

2. Rosengart, TK, et al. Percutaneous and Minimally Invasive Valve Procedures. A Scientific Statement. Circulation, 2008;117. DOI:10.1161/CIRCULATIONAHA.107.188525 

The Human HeartThe Human Heart• Made of a muscle,

called myocardiumy• Four chambers:

• 2 atria (upper chambers) Left side (red)

• 2 ventricles (lower chambers)

( )receives oxygen-rich blood from the lungs andthe lungs and pumps it to the entire body

Right side (blue) receives oxygen-poor blood from the entire b d d it tbody and pumps it to the lungs

The Heart ValvesThe Heart Valves• Valves keep blood flowing in one direction through your

heartheart• Your heart has 4 valves:

• Mitral and tricuspid valves control blood flow between the upper and lower chambers of the heart

• Pulmonary and aortic valves control blood flow out of the heart

Tricuspid valvepMitral valve

Aortic valve

Pulmonary valve

Heart Valve DiseaseHeart Valve Disease• There are two types of heart valve

diseases:• Congenital (from birth)• Degenerative (aging process)

• The most common problems or defects Regurgitation

pare:

• Stenosis or hardening where the valves have a problem opening

Stenosis

• Regurgitation or back-flow of blood where the valves have problems closing

• These problems make your heart work harder to pump the needed amount of blood to your body

• Symptoms tend to develop over time

Diagnosing Heart Valve DiseasePhysicians may use some of the following examinations to detect heart valve disease:

Each patient and their conditions are different. These exams should be conducted by expert diagnosticians.

Symptoms and Physical Findings f H V l Di 3of Heart Valve Disease3

Symptoms Physical FindingsSymptoms• Shortness of breath• Fatigue during exertion

Physical Findings• Heart murmur• Swollen feet or ankles

• Cough (especially when laying down)

• Difficulty sleeping due to y p gcoughing

• Heart palpitations (racing)• Chest pain or tightnessChest pain or tightness• Dizziness

3. Bonow, RO, Carabello, BA, Kanu C, et al. 2008 Focused Update Incorporated Into the ACC/AHA 2006 Guidelines for the Management of Patients With Valvular Heart Disease. Circulation 2008;118;e523‐e661.

Treatment with MedicationTreatment with Medication

“…There is no specific medical therapy for patients who have not yet developed symptoms. Patients who d l d t i t di ldeveloped symptoms require surgery, not medical therapy.”3

3. Bonow, RO, Carabello, BA, Kanu C, et al. 2008 Focused Update Incorporated Into the ACC/AHA 2006 Guidelines for the Management of Patients With Valvular Heart Disease. Circulation 2008;118;e523‐e661.

Aortic Valve StenosisAortic Valve Stenosis

Aortic StenosisAortic Stenosis• Narrowing of the valve

i th t lt i

Normal Calcified

opening that results in less blood flow through the valve

Open

• Caused by a progressive build-up of calcification or hardening of the valve

Closed

hardening of the valve leaflets (flaps)

• The most common type of ypdisease associated with the aortic valve

A narrowed aortic valve reduces efficient blood flow from the left ventricle to the aorta, thus to the rest of the body

Aortic Stenosis GradesAortic Stenosis Grades

• Aortic stenosis (AS) is best ( )described as a disease continuum with varying grades:• Mild• Mild• Moderate• Severe

• Physicians establish how severe the disease is based on the amount of blood that movesamount of blood that moves appropriately through your valves

Aortic Valve ReplacementS i l O iSurgical Options

Conventional Minimal IncisionConventional Minimal Incision

Mini-sternotomyRight AnteriorThoracotomy

Open-chest or Sternotomy

Mitral Valve RegurgitationMitral Valve Regurgitation

Mitral Valve DiseaseMitral Valve Disease• Prolapsed cusps (flaps) are the most

common disease to affect the mitralcommon disease to affect the mitral valve

• Many people have prolapsed cusps with no other problems

Normal

• Some patients with more progressive disease, however, will have what is called mitral regurgitation

Prolapsed• Mitral regurgitation is a condition where the mitral valve does not close tightly, allowing blood to flow backward inside the heart

Prolapsed

the heart• Mitral regurgitation can also be referred

to as mitral insufficiency or mitral incompetence

Causes of Mitral Valve RegurgitationCauses of Mitral Valve Regurgitation• Degeneration – age related wear

and tear• Infection:

• Prior infection such as rheumatic fever• Prior infection such as rheumatic fever that causes scarring and valve damage

• Active infection such as endocarditisC it l h t d f t i d• Congenital heart defects – acquired from time of birth

• Weakened heart muscle from priorWeakened heart muscle from prior heart attacks can also affect the function of the heart valves

Mitral Valve Regurgitation GradesMitral Valve Regurgitation Grades

• Mitral valve regurgitation is best described as g ga disease continuum with varying grades:• Mild• Moderate• Moderate• Severe

• Physicians establish how severe the disease is based on the amount of blood that is moving backward through the mitral valve

• They also evaluate the size of the left ventricle• They also evaluate the size of the left ventricle (pumping chamber) of your heart

Mitral Valve Surgical ApproachesMitral Valve Surgical Approaches

With th it l l d f t thi• With the mitral valve, surgeons do one of two things to the valve:

• Repair – place a ring around the valve to help stabilize the p p g pvalve leaflets (indicated by guidelines3 as primary approach)

• Replacement – remove the damaged valve completely and replace with a new valve (either mechanical or tissue)p ( )

• Depending on the severity of the regurgitation, a repair can very often be performed instead of a full valve replacementvalve replacement

3. Bonow, RO, Carabello, BA, Kanu C, et al. 2008 Focused Update Incorporated Into the ACC/AHA 2006 Guidelines for the Management of Patients With Valvular Heart Disease. Circulation 2008;118;e523‐e661.

Mitral Valve Surgical OptionsMitral Valve Surgical Options

Conventional Minimal Incision

ThoracotomyOpen-chest or Sternotomy

Minimal Incision Valve Surgery

What is Minimal Incision Valve Surgery?g y

Minimal incision valve surgery is a minimally or less invasive approach to surgery that is designed to offer patients an option for valve surgery that is equivalent4 to traditional open-chest heart valve surgery.g y

Minimal incision valve surgery can treat various cardiac diseases including:diseases, including:

• Aortic valve stenosis• Mitral valve regurgitation

Mitral valvesurgery

Additional indications and contraindications

Aortic valvesurgery

4. Schmitto et al. Minimally Invasive Cardiac Valve Surgery, Journal of the American College of Cardiology, State‐of‐the‐Art paper, Vol. 56, n.. 6, 2010.

Why Choose Minimal Incision V l S ?Valve Surgery?

• Less pain 5 • Less time in the hospital and i t i it 9

• Less trauma to the body 6

• Faster recovery and return to normal activity 7

intensive care unit 9

• Shorter amount of time on a breathing machine 9

• Less potential need for blood• Less scarring and better cosmetic

results 8

• Less risk of infection or

Less potential need for blood transfusions 10

complications in the chest bone 6

5. Casselman FP, Van Slyke S, Dom H, Lambrechts D, Vermeulen Y, Vanermen H.  Endoscopic Mitral Valve Repair: Feasible, Reproducible, and Durable. The Journal of Thoracic and Cardiovascular Surgery.  2003; 125: 273‐282273 282

6. Glower DD, et al.  Mitral valve operation via Port Access versus median sternotomy. European Journal of Cardio‐thoracic Surgery; 14 (Suppl. 1) 1998: S143‐S147.

7. Casselman FP, Slycke SV, Wellens F, De Geest R, Degrieck I, VanPraet F, Vermueulen Y, Vanermen H.  Mitral Valve Surgery Can Now Routinely Be Performed Endoscopically.  Circulation. 2003: 108 Suppl 1:II48‐54

8. Mishra YK, Khanna SN, Wasir H, Sharma KK, Mehta Y, Trehan N. Port‐Access Approach for Cardiac Surgical Procedures: Our Experience in 776 Patients. Indian Heart Journal.  2005; 57: 688‐693.

9. Ryan WR, et al., “Mitral Valve Surgery: Comparison of Outcomes in Matched Sternotomy and Port Access Groups”. Presentation at 5th Biennial Meeting of the Society for Heart Valve Disease, June, 2009.

10. Greelish JP, Cohn LH, Leacche M, Mitchell M, Karavas A, Fox J, Byrne JG, Aranki SF, Couper GS.  Minimally invasive mitral valve repair suggests earlier operations for mitral valve disease.  J Thorac Cardiovasc Surg2003; 126:365‐73

Questions to Ask your SurgeonQuestions to Ask your Surgeon

• Do you perform minimal incision valve surgery?y p g y• Of all the isolated valve surgery you perform, what

percentage are minimal incision valve surgery d ? If t 100% h ?procedures? If not 100%, why?

• Am I a minimal incision valve surgery candidate?• Do I have any of the risk factors that exclude me fromDo I have any of the risk factors that exclude me from

minimal incision valve surgery? • [For mitral patients] What is the likelihood that my valve

will be repaired versus replaced? Why?

Questions and AnswersQuestions and Answers

AppendixAppendix

Clinical ResourcesClinical Resources

• www.YourHeartValve.com• www.Edwards.com• www.AmericanHeart.org• www.acc.org• www.MendedHearts.org

H tV l S• www.HeartValveSurgeons.com• www.heart-valve-surgery.com• The Patient’s Guide to Heart Valve Surgery” by AdamThe Patient s Guide to Heart Valve Surgery by Adam

Pick

Minimal Incision Valve SurgeryMinimal Incision Valve Surgery

References1. The Patient’s Guide to Heart Valve Surgery, by Adam Pick

2. Rosengart, TK, et al. Percutaneous and Minimally Invasive Valve Procedures. A Scientific Statement. Circulation, 2008;117. DOI:10 1161/CIRCULATIONAHA 107 188525DOI:10.1161/CIRCULATIONAHA.107.188525

3. Bonow, RO, Carabello, BA, Kanu C, et al. 2008 Focused Update Incorporated Into the ACC/AHA 2006 Guidelines for the Management of Patients With Valvular Heart Disease. Circulation 2008;118;e523‐e661

4. Schmitto et al. Minimally Invasive Cardiac Valve Surgery, Journal of the American College of Cardiology, State‐of‐the‐Art paper, Vol. 56, n.. 6, 2010.

5. Casselman FP, Van Slyke S, Dom H, Lambrechts D, Vermeulen Y, Vanermen H.  Endoscopic Mitral Valve Repair: Feasible, Reproducible, and Durable. The Journal of Thoracic and Cardiovascular Surgery 2003; 125: 273 282Thoracic and Cardiovascular Surgery.  2003; 125: 273‐282

6. Glower DD, et al.  Mitral valve operation via Port Access versus median sternotomy. European Journal of Cardio‐thoracic Surgery; 14 (Suppl. 1) 1998: S143‐S147.

7. Casselman FP, Slycke SV, Wellens F, De Geest R, Degrieck I, VanPraet F, Vermueulen Y, Vanermen H.  Mitral Valve Surgery Can Now Routinely Be Performed Endoscopically.  Circulation. 2003: 108 Suppl 1:II48‐54

8. Mishra YK, Khanna SN, Wasir H, Sharma KK, Mehta Y, Trehan N. Port‐Access Approach for Cardiac Surgical Procedures: Our Experience in 776 Patients. Indian Heart Journal 2005 57 688 693Journal.  2005; 57: 688‐693.

9. Ryan WR, et al., “Mitral Valve Surgery: Comparison of Outcomes in Matched Sternotomy and Port Access Groups”. Presentation at 5th Biennial Meeting of the Society for Heart Valve Disease, June, 2009.

10. Greelish JP, Cohn LH, Leacche M, Mitchell M, Karavas A, Fox J, Byrne JG, Aranki SF, Couper GS.  Minimally invasive mitral valve repair suggests earlier operations for mitral valve disease.  J Thorac Cardiovasc Surg 2003; 126:365‐73

Minimal incision valve surgery (MIVS) is not indicated for patients with moderate to severe peripheral or aortic atherosclerosis, a history of thoracic trauma, aneurysm of the ascending aorta, or for people suffering from severe aortic regurgitation.y , y g , p p g g g

Complications for this procedure are similar to those with any heart surgery procedure and may include injury to the vessels andother structures in the heart, plaque embolization, stroke, sepsis, hematoma at the access site, arrhythmia, arterial thrombosis, cardiac failure, peripheral nerve damage, allergic reaction to contract medium, or death.

Discuss all of these risks with your physician, and other options available to you for the treatment of heart disease.

The information in this booklet was compiled as an educational service by Edwards Lifesciences Corporation, a leader in advancedcardiovascular disease treatments, the number one heart valve company in the world, and the global leader in acute hemodynamic monitoring. Edwards is a trademark of Edwards Lifesciences Corporation. Edwards Lifesciences is a service mark of Edwards Lifesciences Corporation and is registered in the United States Patent and Trademark OfficeLifesciences Corporation and is registered in the United States Patent and Trademark Office.

© 2011 Edwards Lifesciences Corporation.All rights reserved. AR05987