EDWARDS INTUITY Elite Valve System

The purpose of this active, observational, open-label, non-randomized, post-market surveillance study is to confirm that EDWARDS INTUITY Elite reduces cross clamp time (XCT) in MIS setting when compared to published data with a conventional valve within the MIS setting. The published dataset will used as a control group. Then to describe short term (30 days) and long term (6 months) clinical safety, to assess and compare hemodynamic data with EDWARDS INTUITY Elite to a conventional valve at discharge and at 6 months post AVR, to assess Quality of Life at baseline, and at 6 months post AVR to assess NYHA functional class at baseline, discharge, 1 month and at 6 months post AVR to assess Fitness for hospital discharge.

Aortic valve replacement with mechanical or biological heart valves is the treatment of choice for aortic valve stenosis. Over the past several years, life expectancy has increased in industrial nations, but this has been accompanied by a rising rate of elderly patients with multiple illnesses.

Aortic stenosis remains the most common cause of adult valvular heart disease, the prevalence increasing with age. Average survival of patients treated conservatively has historically been reported as 2-5 years from the onset of symptoms. More recent studies have confirmed the dismal prognosis of severe aortic stenosis. Advanced age, reduced left-ventricular ejection fraction, congestive heart failure and renal insufficiency appear to be independent predictors of reduced survival. Asymptomatic patients with very severe aortic stenosis also share a poor prognosis with a high event rate and a risk of rapid functional deterioration. Early surgery offers a therapeutic option to improve clinical outcomes via decreasing cardiac mortality and improving symptoms.

Bioprostheses offer several advantages over mechanical bioprostheses, the most important being freedom from anticoagulation with a low rate of thromboembolic accidents.

In response to clinical need and in support of advances in minimally invasive surgical approaches to conventional AVR, Edwards Lifesciences developed the EDWARDS INTUITY Elite Valve System to achieve clinical benefits by reducing cardiopulmonary bypass and cross clamp times, while facilitating a less invasive approach to aortic valve replacement.

The system includes the EDWARDS INTUITY Elite Valve System, Model 8300AB and the EDWARDS INTUITY Elite Delivery System, Model 8300DB; the valve is based on prior heart valve designs which have a long history of safety and effectiveness and have incorporated additional features designed to improve patient outcomes and safety.

With only 3 guiding sutures and secure balloon expandable frame, the EDWARDS INTUITY Elite Valve system is well suited for smaller incisions and tight access, with an emphasis on procedural efficiency within existing operating suite of the surgeon.

Eligibility Criteria:
Inclusion Criteria:

1. Subject is 18 years or older
2. Subject is symptomatic for aortic stenosis (AS) or mixed aortic stenosis and aortic insufficiency (AS/AI) disease for which isolated surgical aortic valve replacement without concomitant procedures is indicated according to International guidelines.
3. Surgery starts with and is intended to be completed via a minimal invasive surgical approach. MIS is defined as a non-full sternotomy approach such as partial hemi-sternotomy, right anterior thoracotomy.
4. Surgery is intended to be completed with an EDWARDS INTUITY Elite Heart Valve.
5. Subject has signed and dated the investigation informed consent forms prior to any study-specific procedures are performed.
6. Subject is geographically stable and agrees to attend follow-up assessments as specified in the protocol and informed consent.

Exclusion Criteria:

1. Subject is diagnosed with pure aortic insufficiency.
2. Subject requires multiple valve replacement/repair
3. Subject has Type 0 congenital true bicuspid aortic valve (i.e. absence of raphe and commissures are positioned about 180 degrees apart) or unicuspid aortic valve.
4. Subject has severe ventricular dysfunction defined as LVEF \< 25%.
5. Subject has a history of active endocarditis and/or myocarditis ≤ 3 months before the intended treatment/scheduled surgery.
6. Subject has had an acute MI ≤ 3 months before the intended treatment.
7. Subject had a stroke or transient ischemic attack within six months prior to scheduled aortic valve replacement surgery.
8. Subject is oxygen or ventilator dependent.
9. Subject has life expectancy \< 12 months.
10. Female subject is pregnant or lactating.
11. Subject with documented leukopenia (WBC \< 3.5x 103/μL), anemia (Hb \< 10.0 gm/dL or \< 6.2 mmol/L), thrombocytopenia (platelet count \< 100x 103/mL), or history of bleeding diathesis or coagulopathy.
12. Subject has renal insufficiency as determined by Serum creatinine

    ≥ 200 μmol/L (2.27 mg/dL) at screening or end-stage renal disease requiring chronic dialysis.
13. Subject is currently participating in an investigational drug or device trial for which follow-up has not yet been completed.
14. Minimally Invasive access to the heart is not possible due to anatomical constraints or any other pre-existing condition.
15. Aneurysm of the aortic root and/or ascending aorta

Intra-operative exclusion criteria:

1. Subject has Type 0 congenital true bicuspid aortic valve (i.e. absence of raphe and commissures are positioned about 180 degrees apart) or unicuspid aortic valve. (A non-congenital bicuspid valve without a distorted annulus would not be cause for exclusion.)
2. Subject has calcium on the anterior mitral leaflet which cannot be removed.
3. Subject has extensive calcification of the aortic root.
4. Annular deformation which may or may not be caused by too extensive decalcification of the aortic annulus.
5. The position of the coronary ostia relative to the EDWARDS INTUITY Elite Aortic Valve could result in obstruction of blood flow.
6. Minimally Invasive access to the heart is not possible due to anatomical constraints or any other condition (including patient switched to a full sternotomy approach).
7. The device is not available in the correct size for the subject.