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PATIENT INFORMATION

Mitral Regurgitation

TREATING MITRAL REGURGITATION BEFORE IT PROGRESSES

Mitral regurgitation (MR) places an extra burden on your heart and lungs, and your heart may have to work harder to function normally. The mitral valve is a heart valve that lies between the left atrium and left ventricle. The valve opens and closes to ensure that blood flows in only one direction. In mitral regurgitation, the valve does not close completely and blood leaks backward (regurgitates) into the left atrium.1 The more open the valve remains, the more blood regurgitates and the more severe the problem.

SYMPTOMS OF MITRAL REGURGITATION

In some cases, you may have MR but not experience any symptoms. In other cases, you may experience symptoms such as1,2:

Fatigue or inability to exercise

Sensation of feeling the heart beat (palpitations) or a rapid heartbeat

Dry, hacking cough (often worse when lying down)

Shortness of breath

Fainting

Swollen feet or ankles

Betty
BETTY VAUGHN
Patient with mitral regurgitation

“I had no symptoms until I was about 87. When I was going up and down the stairs, I couldn’t breathe. Then I got light-headed, and I got terribly, terribly tired. It was not living, it was existing.”

This testimonial relates an account of an individual’s response to the treatment. This patient’s account is genuine, typical and documented. However, it does not provide any indication, guide, warranty or guarantee as to the response other persons may have to the treatment. Responses to the treatment discussed can and do vary and are specific to the individual patient.

 

If you are experiencing any of these symptoms, talk to your doctor to receive a thorough examination and proper diagnosis. You should also promptly seek treatment if you notice that your symptoms are getting worse — for example, if the swelling in your feet and ankles has increased or if you find it more difficult to perform daily activities such as walking up the stairs.

WHAT CAN HAPPEN IF MITRAL REGURGITATION IS NOT TREATED?

Mitral regurgitation places an extra burden on your heart and lungs. Over time, some people may develop an enlarged heart because it has to work harder to pump blood through the body. If it is not treated, mitral regurgitation can cause other, more serious problems with your heart, such as heart failure. This is a condition that occurs when your heart can’t pump enough blood to meet the needs of your body.1

TREATMENT OPTIONS FOR MITRAL REGURGITATION

Treatment for mitral regurgitation depends on how severe your condition is, and if it’s getting worse.1,2 The goal of treatment is to improve your heart’s function while minimizing your symptoms and avoiding future complications.

  • Medical Management

    Medications may be prescribed to help manage symptoms of mitral regurgitation, such as diuretics for fluid buildup in the legs and lungs. However, these medications only treat the symptoms and do not address the underlying problem with your mitral valve that is causing your disease.

  • Mitral Valve Surgery

    Considered the most effective long-term treatment for mitral regurgitation, surgery gives you the greatest probability for a safe and effective solution over time. Several surgical procedures are available to repair or replace the mitral valve, including traditional opening the sternum (with an incision over the chest and sternum), minimally invasive surgery that does not involve opening the sternum, and less invasive robotic and transcatheter procedures.

    Surgical Mitral Valve Repair

    Surgical Mitral Valve
    Repair

    If mitral valve repair is an option for you, a surgical technique called an annuloplasty may be performed. This procedure typically involves the implantation of a device to tighten or replace the ring around the mitral valve (annulus) so that the valve leaflets can close properly. When needed, other techniques may be used to repair the valve.

    Surgical Mitral Valve Replacement

    Surgical Mitral Valve Replacement

    If the mitral valve cannot be repaired, your doctor may recommend valve replacement with an artificial (prosthetic) valve. Two types of prosthetic mitral valves are available: mechanical or tissue.

    TMVr with Mitraclip therapy for reducing mitral regurgitation

    Transcatheter Mitral Valve Repair (TMVr)*

    TMVr with MitraClip™ therapy, is a less invasive procedure that may be an option for patients with severe mitral regurgitation. Unlike surgery, this procedure does not require chest incisions and temporarily stopping the heart. In this procedure, a clip, or sometimes more, will be implanted onto the center of your mitral valve. This reduces mitral regurgitation, and the valve continues to open and close on either side of the clip, allowing blood to flow through.

    *TMVr is now referred to as TEER (Transcatheter edge-to-edge repair)

SURGICAL MITRAL VALVE REPLACEMENT

If your mitral valve cannot be repaired, your doctor may recommend valve replacement with an artificial (prosthetic) valve. Two types of prosthetic mitral valves are available: mechanical or tissue. Each type of valve offers different benefits and risks, depending on your specific needs.

CHOOSING BETWEEN A MECHANICAL VALVE OR A TISSUE VALVE

Mechanical valves are long lasting but patients are required to take daily blood-thinners for the rest of their lives

Mechanical valves are made of strong, long-lasting materials such as carbon and titanium and are designed to last for the rest of the patients’ life. However, patients are required to take daily blood-thinning medication for the rest of their lives to help prevent blood clots.1,2

Tissue valves can last 10 to 15 years, requiring another surgery if it wears out, do not usually require blood-thinners

Tissue valves are made with tissue from pig or cow heart tissue (or a combination of the two) and can possibly last 10-15 years, requiring another surgery or procedure to replace the valve if it wears out. Tissue valves do not usually require long-term use of blood-thinners.1,2

To determine what type of valve is best for you, your doctor will take many factors into consideration, such as your age, overall health, and medication requirements.1

Less than 50 years old

A mechanical valve is recommended based on a review of current clinical evidence and a discussion with your doctor, especially if:

  • You are already taking a blood thinner for another health problem
  • You can safely take a blood thinner and are willing to do so

A tissue valve may be recommended depending on your lifestyle.

Between 50 to 70 years of age

The type of valve recommended will be based on a review of current clinical evidence and a discussion with your doctor.

Greater than 70 years old

A tissue valve may be recommended with some exceptions depending on your clinical situation if:

  • You do not want to take a blood thinner or you cannot take it safely
  • You are willing to have another valve replacement procedure if the tissue valve wears out

In rare cases, a mechanical heart valve may be recommended.3

MOST PATIENTS CAN EXPECT TO RETURN TO A NORMAL QUALITY AND LENGTH OF LIFE FOR THEIR AGE FOLLOWING SURGERY.4

MECHANICAL HEART VALVE REPLACEMENT WITH MASTERS MITRAL

The Masters Mechanical Heart Valve is made of a hard carbon material that offers unmatched strength and durability. A sewing cuff, made of medical grade fabric, is attached to the valve and allows the surgeon to sew the valve into place in the heart.

Long-term studies have shown that the Masters valve has notable longevity and may last for at least 30 years.5,6

TISSUE HEART VALVE REPLACEMENT WITH EPIC™ PLUS MITRAL

The Epic Plus Mitral valve is a bioprosthetic valve made with both cow and pig tissue configured to maximize valve durability and mimic the function of a healthy human heart valve while minimizing immune system interaction.

Epic Plus Mitral valve is designed to mimic the function of a natural, healthy heart valve. The length of time the Epic Plus Mitral valve will last depends on many factors, including your medical condition and age. Long-term studies of patients who received an Epic Plus Mitral valve showed excellent durability over time.7,8

The information provided is not intended for medical diagnosis or treatment or as a substitute for professional advice. Consult with a physician or qualified healthcare provider for appropriate medical advice.

MAT-2007303 v2.0 | Item approved for U.S. use only.

References

References Mitral Regurgitation

  1. Mayo Clinic. Mitral valve regurgitation. Accessed August 18, 2020.
  2. Nishimura RA, Otto CM, Bonow RO, et al. 2017 AHA/ACC focused update of the 2014 AHA/ACC Guideline for the management of patients with valvular heart disease. Circulation. 2017;135(25):e1159-e1195.

References Surgical Mitral Valve Replacement

  1. Nishimura RA, Otto CM, Bonow RO, et al. 2017 AHA/ACC focused update of the 2014 AHA/ACC Guideline for the management of patients with valvular heart disease. Circulation. 2017;135(25):e1159-e1195.
  2. Harris C, Croce B, Cao C. Tissue and mechanical heart valves. Ann Cardiothorac Surg. 2015;4(4):399.
  3. Data on file at Abbott.
  4. Tan MK, Jarral OA, Thong EH, et al. Quality of life after mitral valve intervention. Interact Cardiovasc Thorac Surg. 2017;24(2):265-272.
  5. Saito S, Tsukui H, Iwasa S, et al. Bileaflet mechanical valve replacement: an assessment of outcomes with 30 years of follow-up. Interact Cardiovasc Thorac Surg. 2016;23(4):599-607.
  6. Emery RW, Krogh CC, Arom KV, et al. The St. Jude Medical cardiac valve prosthesis: a 25-year experience with single valve replacement. Ann Thorac Surg. 2005;79(3):776-783.
  7. Lehmann S, Jawad, K, Meyer, A. Long-term follow-up after porcine xenograft mitral valve replacement. Presented at: 2017 American Association for Thoracic Surgery Mitral Conclave. April 27-28, 2017; New York, NY USA.
  8. Lehmann S, Merk DR, Etz CD, et al. Porcine xenograft for aortic, mitral and double valve replacement: long-term results of 2544 consecutive patients. Eur J Cardiothorac Surg. 2016;49:1150-1156.
Important Safety Information
  • MitraCLIP
  • EPIC PLUS
  • MASTERS SERIES

  • MITRACLIP DELIVERY SYSTEMS
    INDICATION FOR USE
     

    • The MitraClip™ G4 System is indicated for the percutaneous reduction of significant symptomatic mitral regurgitation (MR ≥ 3+) due to primary abnormality of the mitral apparatus [degenerative MR] in patients who have been determined to be at prohibitive risk for mitral valve surgery by a heart team, which includes a cardiac surgeon experienced in mitral valve surgery and a cardiologist experienced in mitral valve disease, and in whom existing comorbidities would not preclude the expected benefit from reduction of the mitral regurgitation.
    • The MitraClip™ G4 System, when used with maximally tolerated guideline-directed medical therapy (GDMT), is indicated for the treatment of symptomatic, moderate-to-severe or severe secondary (or functional) mitral regurgitation (MR; MR ≥ Grade III  per American Society of Echocardiography criteria) in patients with a left ventricular ejection fraction (LVEF) ≥ 20% and ≤ 50%, and a left ventricular end systolic dimension (LVESD) ≤ 70 mm whose symptoms and MR severity persist despite maximally tolerated GDMT as determined by a multidisciplinary heart team experienced in the evaluation and treatment of heart failure and mitral valve disease.

    CONTRAINDICATIONS

    The MitraClip™ G4 System is contraindicated in patients with the following conditions:

    • Patients who cannot tolerate, including allergy or hypersensitivity to, procedural anticoagulation or post procedural anti-platelet regimen
    • Patients with known hypersensitivity to clip components (nickel / titanium, cobalt, chromium, polyester), or with contrast sensitivity
    • Active endocarditis of the mitral valve
    • Rheumatic mitral valve disease
    • Evidence of intracardiac, inferior vena cava (IVC) or femoral venous thrombus

    WARNINGS

    • DO NOT use MitraClip™ outside of the labeled indication.
    • The MitraClip™ G4 Implant should be implanted with sterile techniques using fluoroscopy and echocardiography (e.g. transesophageal [TEE] and transthoracic [TTE]) in a facility with on-site cardiac surgery and immediate access to a cardiac operating room.
    • Read all instructions carefully. Use universal precautions for biohazards and sharps while handling the MitraClip™ G4 System to avoid user injury. Failure to follow these instructions, warnings and precautions may lead to device damage, user injury or patient injury including:
      • MitraClip™ G4 Implant erosion, migration or malposition
      • Failure to deliver MitraClip™ G4 Implant to the  intended site
      • Difficulty or failure to retrieve MitraClip™ G4 system components
    • Use caution when treating patients with hemodynamic instability requiring inotropic support or mechanical heart assistance due to the increased risk of mortality in this patient population. The safety and effectiveness of MitraClip™ in these patients has not been evaluated.
    • Patients with a rotated heart due to prior cardiac surgery in whom the System is used may have a potential risk of experiencing adverse events such as atrial perforation, cardiac tamponade, tissue damage, and embolism which may be avoided with preoperative evaluation and proper device usage.
    • For the Steerable Guide Catheter and Delivery Catheter only:
      • The Guide Catheter: the distal 65 cm of the Steerable Guide Catheter with the exception of the distal soft tip, is coated with a hydrophilic coating.
      • The Delivery Catheter: coated with a hydrophilic coating for a length of approximately 131 cm.
      • Failure to prepare the device as stated in these instructions and failure to handle the device with  care could lead to additional intervention or serious adverse event.
    • The Clip Delivery System is provided sterile and designed for single use only. Cleaning, re-sterilization and / or re-use may result in infections, malfunction of the device and other serious injury or death.
    • Note the product “Use by“ date specified on the package.
    • Inspect all product prior to use. Do not use if the package is open or damaged, or if product is damaged.

    PRECAUTIONS

    • Prohibitive Risk Primary (or degenerative) Mitral Regurgitation
      • Prohibitive risk is determined by the clinical judgment of a heart team, including a cardiac surgeon experienced in mitral valve surgery and a cardiologist experienced in mitral valve disease, due to the presence of one or more of the following documented surgical risk factors:
        • 30-day STS predicted operative mortality risk score of
          • ≥8% for patients deemed likely to undergo mitral valve replacement or
          • ≥6% for patients deemed likely to undergo mitral valve repair
      • Porcelain aorta or extensively calcifed ascending aorta.
      • Frailty (assessed by in-person cardiac surgeon consultation)
      • Hostile chest
      • Severe liver disease / cirrhosis (MELD Score > 12)
      • Severe pulmonary hypertension (systolic pulmonary artery pressure > 2/3 systemic pressure)
      • Unusual extenuating circumstance, such as right ventricular dysfunction with severe tricuspid regurgitation, chemotherapy for malignancy, major bleeding diathesis, immobility, AIDS, severe dementia, high risk of aspiration, internal mammary artery (IMA) at high risk of injury, etc.
      • Evaluable data regarding safety or effectiveness is not available for prohibitive risk Primary patients with an LVEF < 20% or an LVESD > 60 mm. MitraClip™ should be used only when criteria for clip suitability for Primary have been met.
      • The heart team should include a cardiac surgeon experienced in mitral valve surgery and a cardiologist experienced in mitral valve disease and may also include appropriate physicians to assess the adequacy of heart failure treatment and valvular anatomy.
    • Secondary Mitral Regurgitation
      • Evaluable data regarding safety or effectiveness is not available for secondary MR patients with an LVEF < 20% or an LVESD > 70 mm.
      • The multidisciplinary heart team should be experienced in the evaluation and treatment of heart failure and mitral valve disease and determine that symptoms and MR severity persist despite maximally tolerated GDMT.

    POTENTIAL COMPLICATIONS AND ADVERSE EVENTS

    The following ANTICIPATED EVENTS have been identified as possible complications of the MitraClip™ G4 procedure.

    • Allergic reactions or hypersensitivity to latex, contrast agent, anaesthesia, device materials (nickel / titanium, cobalt, chromium, polyester), and drug reactions to anticoagulation, or antiplatelet drugs
    • Vascular access complications which may require transfusion or vessel repair including:
      • wound dehiscence
      • catheter site reactions
      • Bleeding (including ecchymosis, oozing, hematoma, hemorrhage, retroperitoneal hemorrhage)
      • Arteriovenous fistula, pseudoaneurysm, aneurysm, dissection, perforation / rupture, vascular occlusion
      • Emboli (air thrombotic material, implant, device component)
      • Peripheral Nerve Injury
    • Lymphatic complications
    • Pericardial complications which may require additional intervention, including:
      • Pericardial effusion
      • Cardiac tamponade
      • Pericarditis
    • Cardiac complications which may require additional interventions or emergency cardiac surgery, including:
      • Cardiac perforation
      • Atrial septal defect
    • Mitral valve complications, which may complicate or prevent later surgical repair, including:
      • Chordal entanglement / rupture
      • Single Leaflet Device Attachment (SLDA)
      • Thrombosis
      • Dislodgement of previously implanted devices
      • Tissue damage
      • Mitral valve stenosis
      • Persistent or residual mitral regurgitation
      • Endocarditis
    • Cardiac arrhythmias (including conduction disorders, atrial arrhythmias, ventricular arrhythmias)
    • Cardiac ischemic conditions (including myocardial infarction, myocardial ischemia, and unstable / stable angina)
    • Venous thromboembolism (including deep vein thrombosis, pulmonary embolism, post procedure pulmonary embolism)
    • Stroke / Cerebrovascular accident (CVA) and Transient Ischemic Attack (TIA)
    • System organ failure:
      • Cardio-respiratory arrest
      • Worsening heart failure
      • Pulmonary congestion
      • Respiratory dysfunction / failure / atelectasis
      • Renal insufficiency or failure
      • Shock (including cardiogenic and anaphylactic)
    • Blood cell disorders (including coagulopathy, hemolysis, and Heparin Induced Thrombocytopenia (HIT))
    • Hypotension / hypertension
    • Infection including:
      • Urinary Tract Infection (UTI)
      • Pneumonia
      • Septicemia
    • Nausea / vomiting
    • Chest pain
    • Dyspnea
    • Edema
    • Fever or hyperthermia
    • Pain
    • Death
    • Fluoroscopy, Transesophageal echocardiogram (TEE) and Transthoracic echocardiogram (TTE) -related complications:
      • Skin injury or tissue changes due to exposure to  ionizing radiation
      • Esophageal irritation
      • Esophageal perforation
      • Gastrointestinal bleeding

  • EPICTM PLUS/ EPICTM PLUS SUPRA STENTED PORCINE TISSUE VALVES
    INDICATION FOR USE


    The Epic™ Plus valve is indicated for patients requiring replacement of a diseased, damaged, or malfunctioning native aortic and/or mitral heart valve. It may also be used as a replacement for a previously implanted aortic and/or mitral prosthetic heart valve.
    The Epic™ Plus Supra valve is indicated for patients requiring replacement of a diseased, damaged, or malfunctioning native aortic heart valve. It may also be used as a replacement for a previously implanted aortic prosthetic heart valve.

    CONTRAINDICATIONS

    None known.

    WARNINGS

    • Valve size selection is based on the size of the recipient annulus, and for supra-annular aortic placement, the anatomy of the sinotubular space. Implantation of an inappropriately large bioprosthesis may result in stent deformation, valvular incompetence, valve damage, diminished tissue durability and/or damage to the surrounding tissues. The use of an inappropriately small bioprosthesis may result in suboptimal hemodynamics. Use only the E2000 Epic™ Plus Heart Valve Sizer Set with the Epic™ Plus and Epic™ Plus Supra valves.
    • Accelerated deterioration due to calcific degeneration of the Epic Plus and Epic Plus Supra valve may occur in:
      • children, adolescents, or young adults;
      • patients with altered calcium metabolism (e.g., patients with hyperparathyroidism or chronic renal failure); or
      • individuals requiring hemodialysis.
    • For single use only. Do not reuse or resterilize. Attempts to resterilize the valve may result in valve malfunction, inadequate sterilization, or patient harm.
    • Passage of a catheter or transvenous pacing lead through any bioprosthesis may damage the valve and is therefore not recommended.
    • Do not use if:
      • the valve has been dropped, damaged, or mishandled in any way, or if there is any sign of deterioration;
      • the expiration date has elapsed;
      • the tamper-evident container seal is damaged, broken, or missing, or if fluid is leaking from the packaging; or
      • the storage solution does not completely cover the valve.

    PRECAUTIONS

    • The safety and effectiveness of the Epic™ Plus and Epic™ Plus Supra valves has not been established for the following specific populations:
      • patients who are pregnant
      • nursing mothers
      • patients with chronic renal failure
      • patients with aneurysmal aortic degenerative conditions (e.g., cystic medial necrosis, Marfan’s syndrome)
      • patients with chronic endocarditis
      • patients requiring pulmonic or tricuspid valve replacement
      • children, adolescents, or young adults
    • Sizers are supplied non-sterile, and must be cleaned and sterilized prior to each use. Do not use cracked, deformed, or damaged sizer set components.
    • Do not pass the flanged portion of the valve replica sizing tool through the annulus.
    • Do not place the non-sterile exterior of the valve container in the sterile field.
    • Do not expose the valve to solutions other than the formaldehyde valve storage solution in which it was shipped, the sterile isotonic saline solution used during the rinsing procedure, or the sterile isotonic saline solution used to irrigate the valve.
    • Do not add antibiotics to either the formaldehyde valve storage solution or the rinse solution.
    • Do not apply antibiotics to the valve.
    • Do not allow the valve tissue to dry. Place the valve in sterile isotonic saline rinse solution immediately upon removal from the valve storage solution. Once removed from this solution, the valve should be periodically irrigated during implantation.
    • Do not use the valve if shipping temperature indicators on the product carton have turned red, or if the valve has been improperly stored in temperature conditions outside of the 5 °C to 25 °C range.
    • Do not implant the valve without thoroughly rinsing as directed.
    • Do not lacerate the valve tissue. If a valve is damaged, the valve must be explanted and replaced.
    • Do not attempt to repair a valve. Damaged valves must not be used.
    • Do not use cutting edge needles, unprotected forceps, or sharp instruments as they may cause structural damage to valve.
    • Never handle the leaflet tissue.
    • Position the mitral valve in a manner to avoid commissure obstruction of the left ventricular outflow tract, and minimize any potential of commissure contact with the ventricular wall.
    • Position the aortic valve so that the stent posts do not obstruct the coronary ostia or come in direct contact with the aortic wall.
    • When implanting the Epic™ Plus heart valve, assess the suitability of the selected valve size and stent post position for a potential future valve-in-valve procedure and whether the transcatheter valve-in-valve procedure may result in left ventricular outflow tract or coronary ostia obstruction. For future valve-in-valve procedure in an Epic Plus valve, refer to the instructions for use supplied with the transcatheter heart valve along with reference dimensions in Table 1 (in the IFU) to determine compatibility. The safety and effectiveness of valve-in-valve procedures in an Epic™ Plus or an Epic™ Plus Supra valve have not been established.
    • Avoid prolonged contact with the formaldehyde storage solution. Immediately after contact, thoroughly flush any skin exposed to the solution with water. In case of contact with eyes, flush with water and seek appropriate medical care.

    ADVERSE EVENTS

    The clinical investigation of the Epic valve supports the safety and effectiveness of the Epic™ Plus valve and the Epic™ Plus Supra valve. Between January 2003 and March 2006, seven-hundred and sixty-two (762) subjects were implanted with 791 Epic Valve(s) at 19 investigational sites in the United States (U.S.), and three sites in Canada. Five-hundred and fifty-seven (557) subjects received isolated aortic replacement, 176 received isolated mitral replacement, and 29 received replacement of both the aortic and mitral valves. The cumulative follow-up for all subjects was 773.51 patient-years with a mean follow-up of 1.02 patient-years (s.d. = 0.71 patient-years, range 0 – 3.10 patient-years).

    Potential Adverse Events

    Adverse events potentially associated with the use of bioprosthesis heart valves (in alphabetical order) include: 

    • angina
    • cardiac arrhythmias
    • endocarditis
    • heart failure
    • hemolysis
    • hemolytic anemia
    • hemorrhage, anticoagulant/antiplatelet-related
    • leak, transvalvular or paravalvular
    • myocardial infarction
    • nonstructural dysfunction (entrapment by pannus or suture, inappropriate sizing or positioning, or other)
    • prosthesis regurgitation
    • stroke
    • structural deterioration (calcification, leaflet tear, or other)
    •  thromboembolism
    •  valve thrombosis

    It is possible that these complications could lead to:

    •  reoperation
    •  explantation
    •  permanent disability
    •  death

  • SJM™ MASTERS SERIES
    MECHANICAL HEART VALVE


    The SJM™ Masters Series Mechanical Heart Valve is intended for use as a replacement valve in patients with a diseased, damaged, or malfunctioning aortic or mitral heart valve. This device may also be used to replace a previously implanted prosthetic heart valve.

    CONTRAINDICATIONS

    The SJM™ Masters Series Mechanical Heart Valve is contraindicated for individuals unable to tolerate anticoagulation therapy.

    WARNINGS

    • For single use only. Attempts to reuse the valve may result in valve malfunction, inadequate sterilization, or patient harm.
    • Do not use if:
      • The valve has been dropped, damaged, or mishandled in any way.
      • The expiration date has elapsed.
      • The tamper-evident container seal or inner/outer tray seals are damaged, broken or missing.
    • Remove any residual tissue that may impair valve size selection, correct seating of the valve, rotation of the valve, or leaflet motion.
    • Proper valve size selection is crucial. Do not oversize the valve. If the native annulus measurement falls between two SJM™ Masters Series Mechanical Heart Valve sizes, use the smaller size SJM™ Masters Series Mechanical Heart Valve.
    • Use only St. Jude Medical™ mechanical heart valve sizers.
    • The outer tray is not sterile, and should not be placed in the sterile field.
    • To minimize direct handling of the valve during implantation, do not remove the holder/rotator until the valve has been seated in the annulus.
    • Do not use hard or rigid instruments to test leaflet mobility, as this may result in structural damage to the valve or thromboembolic complications. Use a St. Jude Medical™ leaflet tester to gently test valve leaflet mobility.
    • Place sutures in the outer half of the valve sewing cuff.
    • Never apply force to the valve leaflets. Force may cause structural damage to the valve.
    • Use only SJM™ Valve Holder/Rotators to perform valve rotation. Use of other instruments could result in structural damage. The valve holder/ rotator is intended for single use only and should be discarded after surgery.
    • The two retention sutures on the valve holder/ rotator must be cut and removed before the SJM™ Masters Series Mechanical Heart Valve can be rotated.
    • Do not pass catheters or other instruments through St. Jude Medical™ mechanical heart valves. This could result in scratched or damaged valve components, or leaflet fracture or dislodgment.
    • Cut suture ends short, especially in the vicinity of the pivot guards, to prevent leaflet impingement.
    • Three cases of impeded leaflet motion not satisfactorily explained were reported in a survey of 149 centers reporting on 4,934 patients implanted over a period of three (3) years. A number of other cases occurred early in the investigation of this prosthesis; however, the rates of occurrence are not statistically determinable.

    PRECAUTIONS

    • Do not touch the prosthetic valve unnecessarily, even with gloved hands. This may cause scratches or surface imperfections that may lead to thrombus formation.
    • Be careful not to cut or tear the valve sewing cuff when removing the identification tag and the holder/rotator from the SJM™ Masters Series Mechanical Heart Valve.
    • Before placing sutures in the valve sewing cuff, verify that the valve is mounted correctly on the valve holder/rotator.
    • To avoid structural damage, the valve must be rotated in the fully closed position.
    • To minimize rotational torque, verify that the valve holder/rotator is properly seated in the valve, and that the valve holder handle is perpendicular to the valve (Figures 15a and 15b).
    • Remove any loose suture or thread, which may be a source of thrombus or thromboembolism.

    POTENTIAL ADVERSE EVENTS

    Complications associated with replacement mechanical heart valves include, but are not limited to:

    hemolysis; infections; thrombus; or thromboembolism; valve dehiscence; unacceptable hemodynamic performance; hemorrhagic complications secondary to anticoagulation therapy; prosthetic failure; and heart failure or death.

    Any of these complications may require reoperation or explantation of the device.

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