Standardized quality of life surveys allow physicians to evaluate the effectiveness of different treatment methods and the physical and psychological benefits a patient is likely to receive from a particular treatment.In the EVEREST II HRR,the patients were asked to complete the SF-36 QOL survey at baseline, 30 days and 12 months. The physical & mental function were assessed by the Physical Component Summary (PCS) score & Mental Component Summary (MCS) score. The PCS & MCS norms for 65-75 year olds are 44 and 52 respectively; and 31 & 46 for congestive heart failure (CHF) patients respectively. Each scale from the SF-36 is an algebraic sum of responses for all items in that scale.For ease of analysis each scale is then transformed to a 0-100 scale using a formula that converts the lowest & highest possible scores to 0 & 100 respectively.The scoring of the SF-36 indicates that 0% in a domain represents the poorest possible QoL & 100% indicates full QoL.

Left Ventricular End Diastolic Volume (LVEDV) as determined by the core echocardiography laboratory from a transthoracic echocardiogram (TTE).

Left Ventricular End Systolic Volume (LVESV) as determined by the core echocardiography laboratory from a transthoracic echocardiogram (TTE).

Left Ventricular Internal Dimension in diastole (LVIDd) and Left Ventricular Internal Dimension in systole (LVIDs) as determined by the core echocardiography laboratory from a transthoracic echocardiogram (TTE).

Number of patients with incidence of re-hospitalizations for CHF in the 12-months after the MitraClip implant procedure.

Incidence of re-hospitalizations for CHF in the 12-months after the MitraClip implant procedure.

Left Ventricular End Diastolic Volume (LVEDV) as determined by the core echocardiography laboratory from a transthoracic echocardiogram (TTE).

Left Ventricular End Systolic Volume (LVESV) as determined by the core echocardiography laboratory from a transthoracic echocardiogram (TTE).

Left Ventricular Internal Dimension in diastole (LVIDd) and Left Ventricular Internal Dimension in systole (LVIDs) as determined by the core echocardiography laboratory from a transthoracic echocardiogram (TTE).

Combined clinical endpoint of death, myocardial infarction, reoperation for failed surgical repair or replacement, nonelective cardiovascular surgery for adverse events, stroke, renal failure, deep wound infection, ventilation for greater than 48 hours, GI complication requiring surgery, new onset of permanent atrial fibrillation, septicemia, and transfusion of 2 or more units of blood.

Percutaneous Clip procedure or surgery with no occurrence of in-hospital MAE.

Combined clinical endpoint of death, myocardial infarction, reoperation for failed surgical repair or replacement, nonelective cardiovascular surgery for adverse events, stroke, renal failure, deep wound infection, ventilation for greater than 48 hours, GI complication requiring surgery, new onset of permanent atrial fibrillation, septicemia, and transfusion of 2 or more units of blood.

Combined clinical endpoint of death, myocardial infarction, reoperation for failed surgical repair or replacement, nonelective cardiovascular surgery for adverse events, stroke, renal failure, deep wound infection, ventilation for greater than 48 hours, GI complication requiring surgery, new onset of permanent atrial fibrillation, septicemia, and transfusion of 2 or more units of blood.

Defined as the occurrence of any of the following resulting from the index procedure:

• Hematoma at access site >6 cm;
• Retroperitoneal hematoma;
• Arterial-venous fistula;
• Symptomatic peripheral ischemia/ nerve injury with clinical signs or symptoms lasting >24 hours;
• Vascular surgical repair at catheter access sites;
• Pulmonary embolism;
• Ipsilateral deep vein thrombus; or
• Access site-related infection requiring intravenous antibiotics and/or extended hospitalization.

Defined as the occurrence of any of the following resulting from the index procedure:

• Hematoma at access site >6 cm;
• Retroperitoneal hematoma;
• Arterial-venous fistula;
• Symptomatic peripheral ischemia/ nerve injury with clinical signs or symptoms lasting >24 hours;
• Vascular surgical repair at catheter access sites;
• Pulmonary embolism;
• Ipsilateral deep vein thrombus; or
• Access site-related infection requiring intravenous antibiotics and/or extended hospitalization.

Defined as procedure related bleeding that requires a transfusion of ≥2 units of blood and/or surgical intervention.

Defined as procedure related bleeding that requires a transfusion of ≥2 units of blood and/or surgical intervention.

Defined as any mural thrombus or thromboembolism in the vasculature (excluding central nervous system events) confirmed by standard clinical and laboratory testing and which requires intervention.

Defined as any mural thrombus or thromboembolism in the vasculature (excluding central nervous system events) confirmed by standard clinical and laboratory testing and which requires intervention.

Evidence of formation of an independently moving thrombus on any part of the Clip or any commercially available implant used during surgery by echocardiography or fluoroscopy. If Clip is explanted or an autopsy is performed this diagnosis should be confirmed.

Evidence of formation of an independently moving thrombus on any part of the Clip or any commercially available implant used during surgery by echocardiography or fluoroscopy. If Clip is explanted or an autopsy is performed this diagnosis should be confirmed.

Defined as new onset of anemia associated with laboratory evidence of red cell destruction. Diagnosed when plasma free hemoglobin is greater than 40 mg/dL on two measures within 24 hours or on one measure if intervention is initiated based on other clinical symptoms

Defined as new onset of anemia associated with laboratory evidence of red cell destruction. Diagnosed when plasma free hemoglobin is greater than 40 mg/dL on two measures within 24 hours or on one measure if intervention is initiated based on other clinical symptoms.

Includes all new onset atrial fibrillation and heart block requiring placement of a permanent pacemaker.

Includes all new onset atrial fibrillation and heart block requiring placement of a permanent pacemaker.

Using Duke Criteria, endocarditis can be confirmed by:

Pathological criteria: Endocarditis is confirmed if microorganisms are identified by culture or histology in a vegetation, embolized vegetation, or an intracardiac abscess; or if pathological lesions are observed & histologically confirmed showing active endocarditis.

Clinical criteria: Endocarditis is confirmed by the presence of 2 major criteria, 1 major plus 3 minor criteria, or 5 minor criteria. Major criteria include persistently +ve blood cultures with the presence of typical organisms for endocarditis; persistent bacteremia; evidence of endocardial involvement with positive echocardiogram with signs of oscillating vegetation, abscesses, valve perforation, new partial dehiscence of prosthetic valve or new valvular regurgitation. Minor criteria include predisposing heart condition, fever, vascular phenomena, immunologic phenomena, & positive blood culture or echocardiogram not meeting major criteria.

Using Duke Criteria, endocarditis can be confirmed by:

Pathological criteria: Endocarditis is confirmed if microorganisms are identified by culture or histology in a vegetation, embolized vegetation, or an intracardiac abscess; or if pathological lesions are observed & histologically confirmed showing active endocarditis.

Clinical criteria: Endocarditis is confirmed by the presence of 2 major criteria, 1 major plus 3 minor criteria, or 5 minor criteria.

Major criteria include persistently +ve blood cultures with the presence of typical organisms for endocarditis; persistent bacteremia; evidence of endocardial involvement with positive echocardiogram with signs of oscillating vegetation, abscesses, valve perforation, new partial dehiscence of prosthetic valve or new valvular regurgitation.

Minor criteria include predisposing heart condition, fever, vascular phenomena, immunologic phenomena, & positive blood culture or echocardiogram not meeting major criteria.

Occurrence of clinically significant ASD as a result of the procedure requiring intervention.

Occurrence of clinically significant ASD as a result of the procedure requiring intervention.

Mitral stenosis associated with a total mitral valve orifice area less than 1.5 cm2.

Mitral stenosis associated with a total mitral valve orifice area less than 1.5 cm2.

Mitral stenosis associated with a total mitral valve orifice area less than 1.5 cm2.

Mitral stenosis associated with a total mitral valve orifice area less than 1.5 cm2.

Mitral stenosis associated with a total mitral valve orifice area less than 1.5 cm2.

Mitral valve area as measured by core lab echocardiography.

Mitral valve area as measured by core lab echocardiography.

Mitral valve area as measured by core lab echocardiography.

Mitral valve area as measured by core lab echocardiography.

Mitral valve area as measured by core lab echocardiography.

Mitral valve area as measured by core lab echocardiography.

Mitral valve area as measured by core lab echocardiography.

Mitral valve area as measured by core lab echocardiography.

Mitral valve area as measured by core lab echocardiography.

Mitral valve area as measured by core lab echocardiography.

Mitral valve area as measured by core lab echocardiography.

Mitral valve area as measured by core lab echocardiography.

Mitral valve area as measured by core lab echocardiography by planimetry and indexed to body surface area [MVA Index = MVA (cm^2)/BSA (m^2)].

Mitral valve area as measured by core lab echocardiography by planimetry and indexed to body surface area [MVA Index = MVA (cm^2)/BSA (m^2)].

Mitral valve area as measured by core lab echocardiography by planimetry and indexed to body surface area [MVA Index = MVA (cm^2)/BSA (m^2)].

Mitral valve area as measured by core lab echocardiography by planimetry and indexed to body surface area [MVA Index = MVA (cm^2)/BSA (m^2)].

Mitral valve area as measured by core lab echocardiography by planimetry and indexed to body surface area [MVA Index = MVA (cm^2)/BSA (m^2)].

Mitral valve area as measured by core lab echocardiography by planimetry and indexed to body surface area [MVA Index = MVA (cm^2)/BSA (m^2)].

Mitral valve area as measured by core lab echocardiography using the pressure half-time formula and indexed to Body surface area (BSA).

[MVA Index = MVA (cm^2)/BSA (m^2)]

Mitral valve area as measured by core lab echocardiography using the pressure half-time formula and indexed to body surface area [MVA Index = MVA (cm^2)/BSA (m^2)].

Mitral valve area as measured by core lab echocardiography using the pressure half-time formula and indexed to body surface area [MVA Index = MVA (cm^2)/BSA (m^2)].

Mitral valve area as measured by core lab echocardiography using the pressure half-time formula and indexed to body surface area [MVA Index = MVA (cm^2)/BSA (m^2)].

Mitral valve area as measured by core lab echocardiography using the pressure half-time formula and indexed to body surface area [MVA Index = MVA (cm^2)/BSA (m^2)].

Mitral valve area as measured by core lab echocardiography using the pressure half-time formula and indexed to body surface area [MVA Index = MVA (cm^2)/BSA (m^2)].

Defined as the mean pressure gradients across the mitral valve as measured by echocardiography.

Defined as the mean pressure gradients across the mitral valve as measured by echocardiography.

Defined as the mean pressure gradients across the mitral valve as measured by echocardiography.

Defined as the mean pressure gradients across the mitral valve as measured by echocardiography.

Defined as the mean pressure gradients across the mitral valve as measured by echocardiography.

Defined as the mean pressure gradients across the mitral valve as measured by echocardiography.

Mitral valve area as measured by core lab echocardiography and indexed to body surface area [MVA Index = MVA (cm^2)/BSA (m^2)]

Mitral valve area as measured by core lab echocardiography and indexed to body surface area [MVA Index = MVA (cm^2)/BSA (m^2)]

New onset use of Coumadin or warfarin to treat a potential thrombus on a defibrillator lead.

New onset use of Coumadin or warfarin to treat a potential thrombus on a defibrillator lead.

New onset use of Coumadin or warfarin to treat a potential thrombus on a defibrillator lead.

Discharge to a nursing home or skilled nursing facility following discharge from the hospital after definitive treatment.

Defined as the number of days from the end of the procedure until the patient is discharged from the hospital. This does not include time in a nursing or skilled care facility.

Number of hours patients are in an intensive care unit or step down unit before discharge or moving to a standard care unit.

Rate of successful delivery and deployment of Clip implants with echocardiographic evidence of leaflet approximation and retrieval of the investigational delivery catheter.

Successful implantation of the Clip (s) with resulting MR severity of 2+ of less at discharge or a 1 grade MR reduction at discharge accompanied by a 1 level reduction in NYHA.

MR Severity: Site-assessed mitral regurgitation severity using echocardiography. MR severity is graded on a scale of 0+ to 4+ where 0+ means absence of mitral regurgitation, 1+ is mild, 1+ to 2+ is mild-to-moderate, 2+ to 3+ is moderate to moderate-to-Severe, 3+ is moderate-to-severe, 3+ to 4+ is moderate-to-severe to severe, 4+ is severe.

MR Severity: Site-assessed mitral regurgitation severity using echocardiography. MR severity is graded on a scale of 0+ to 4+ where 0+ means absence of mitral regurgitation, 1+ is mild, 1+ to 2+ is mild-to-moderate, 2+ to 3+ is moderate to moderate-to-Severe, 3+ is moderate-to-severe, 3+ to 4+ is moderate-to-severe to severe, 4+ is severe.

MR Severity: Site-assessed mitral regurgitation severity using echocardiography. MR severity is graded on a scale of 0+ to 4+ where 0+ means absence of mitral regurgitation, 1+ is mild, 1+ to 2+ is mild-to-moderate, 2+ to 3+ is moderate to moderate-to-Severe, 3+ is moderate-to-severe, 3+ to 4+ is moderate-to-severe to severe, 4+ is severe.

MR Severity: Site-assessed mitral regurgitation severity using echocardiography. MR severity is graded on a scale of 0+ to 4+ where 0+ means absence of mitral regurgitation, 1+ is mild, 1+ to 2+ is mild-to-moderate, 2+ to 3+ is moderate to moderate-to-Severe, 3+ is moderate-to-severe, 3+ to 4+ is moderate-to-severe to severe, 4+ is severe.

MR Severity: Site-assessed mitral regurgitation severity using echocardiography. MR severity is graded on a scale of 0+ to 4+ where 0+ means absence of mitral regurgitation, 1+ is mild, 1+ to 2+ is mild-to-moderate, 2+ to 3+ is moderate to moderate-to-Severe, 3+ is moderate-to-severe, 3+ to 4+ is moderate-to-severe to severe, 4+ is severe.

MR Severity: Site-assessed mitral regurgitation severity using echocardiography. MR severity is graded on a scale of 0+ to 4+ where 0+ means absence of mitral regurgitation, 1+ is mild, 1+ to 2+ is mild-to-moderate, 2+ to 3+ is moderate to moderate-to-Severe, 3+ is moderate-to-severe, 3+ to 4+ is moderate-to-severe to severe, 4+ is severe.

Defined as the proportion of Acute Procedural Success patients with MR severity grade of 2+ or less that have not required surgery for valve dysfunction.

Defined as the proportion of Acute Procedural Success patients with MR severity grade of 2+ or less that have not required surgery for valve dysfunction.

Proportion of patients who have an acute reduction in MR severity of at least one grade (as measured by the discharge echocardiogram) that have not required surgery for valve dysfunction and meet either of the following: 1) MR severity grade of 2+ or less or 2) a one grade reduction in MR severity compared to baseline accompanied by at least a one level reduction in NYHA.

Proportion of patients who have an acute reduction in MR severity of at least one grade (as measured by the discharge echocardiogram) that have not required surgery for valve dysfunction and meet either of the following: 1) MR severity grade of 2+ or less or 2) a one grade reduction in MR severity compared to baseline accompanied by at least a one level reduction in NYHA.

Class I: Patients with cardiac disease but without resulting limitations of physical activity.

Class II: Patients with cardiac disease resulting in slight limitation of physical activity. Patients are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain.

Class III: Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary physical activity causes fatigue, palpitation dyspnea, or anginal pain.

Class IV: Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased.

Class I: Patients with cardiac disease but without resulting limitations of physical activity.

Class II: Patients with cardiac disease resulting in slight limitation of physical activity. Patients are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain.

Class III: Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary physical activity causes fatigue, palpitation dyspnea, or anginal pain.

Class IV: Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased.

Class I: Patients with cardiac disease but without resulting limitations of physical activity.

Class II: Patients with cardiac disease resulting in slight limitation of physical activity. Patients are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain.

Class III: Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary physical activity causes fatigue, palpitation dyspnea, or anginal pain.

Class IV: Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased.

Class I: Patients with cardiac disease but without resulting limitations of physical activity.

Class II: Patients with cardiac disease resulting in slight limitation of physical activity. Patients are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain.

Class III: Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary physical activity causes fatigue, palpitation dyspnea, or anginal pain.

Class IV: Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased.

Left Ventricular End Diastolic Volume (LVEDV) as determined by the core echocardiography laboratory from a transthoracic echocardiogram (TTE).

Left Ventricular End Diastolic Volume (LVEDV) as determined by the core echocardiography laboratory from a transthoracic echocardiogram (TTE).

Left Ventricular End Diastolic Volume (LVEDV) as determined by the core echocardiography laboratory from a transthoracic echocardiogram (TTE).

Left Ventricular End Diastolic Volume (LVEDV) as determined by the core echocardiography laboratory from a transthoracic echocardiogram (TTE).

Left Ventricular End Systolic Volume (LVESV) as determined by the core echocardiography laboratory from a transthoracic echocardiogram (TTE).

Left Ventricular End Systolic Volume (LVESV) as determined by the core echocardiography laboratory from a transthoracic echocardiogram (TTE).

Left Ventricular End Systolic Volume (LVESV) as determined by the core echocardiography laboratory from a transthoracic echocardiogram (TTE).

Left Ventricular End Systolic Volume (LVESV) as determined by the core echocardiography laboratory from a transthoracic echocardiogram (TTE).

Left Ventricular Internal Dimension in diastole (LVIDd) and Left Ventricular Internal Dimension in systole (LVIDs) as determined by the core echocardiography laboratory from a transthoracic echocardiogram (TTE).

Left Ventricular Internal Dimension in diastole (LVIDd) and Left Ventricular Internal Dimension in systole (LVIDs) as determined by the core echocardiography laboratory from a transthoracic echocardiogram (TTE).

Left Ventricular Internal Dimension in diastole (LVIDd) and Left Ventricular Internal Dimension in systole (LVIDs) as determined by the core echocardiography laboratory from a transthoracic echocardiogram (TTE).

Left Ventricular Internal Dimension in diastole (LVIDd) and Left Ventricular Internal Dimension in systole (LVIDs) as determined by the core echocardiography laboratory from a transthoracic echocardiogram (TTE).

Defined as the number of days hospitalized for CHF in the 12-months prior to the Clip implant procedure date compared to the number of days re-hospitalized for CHF in the 12-months after Clip implant.

Defined as the number of hospital admissions (i.e. events) for which the primary diagnosis for hospitalization is congestive heart failure, in the 12-months post-discharge following the MitraClip procedure.

Regurgitant volume as measured by the core echocardiographic laboratory at follow-up.

Regurgitant volume as measured by the core echocardiographic laboratory at follow-up.

Regurgitant volume as measured by the core echocardiographic laboratory at follow-up.

RF is defined as the percentage of the left ventricular (LV) stroke volume that regurgitates into the left atrium.

RF is defined as the percentage of the left ventricular (LV) stroke volume that regurgitates into the left atrium.

RF is defined as the percentage of the left ventricular (LV) stroke volume that regurgitates into the left atrium.

CO is defined as the volume of blood pumped by the left ventricle per unit time (L/min).

CO is defined as the volume of blood pumped by the left ventricle per unit time (L/min)

CO is defined as the volume of blood pumped by the left ventricle per unit time (L/min)

Cardiac index (cardiac output divided by body surface area) as measured by core lab echocardiography.

Cardiac index (cardiac output divided by body surface area) as measured by core lab echocardiography.

Cardiac index (cardiac output divided by body surface area) as measured by core lab echocardiography.

Left Ventricular Ejection Fraction (LVEF) as determined by the core echocardiography laboratory.

Left Ventricular Ejection Fraction (LVEF) as determined by the core echocardiography laboratory.

Left Ventricular Ejection Fraction (LVEF) as determined by the core echocardiography laboratory.

Left Ventricular Ejection Fraction (LVEF) as determined by the core echocardiography laboratory.

Left Ventricular Ejection Fraction (LVEF) as determined by the core echocardiography laboratory.

Left Ventricular Ejection Fraction (LVEF) as determined by the core echocardiography laboratory.

Percentage of patients who did not undergo surgical mitral valve repair or replacement after the index MitraClip procedure

Percentage of patients who did not undergo surgical mitral valve repair or replacement after the index MitraClip procedure

Percentage of patients who did not undergo surgical mitral valve repair or replacement after the index MitraClip procedure

Percentage of patients who did not undergo surgical mitral valve repair or replacement after the index MitraClip procedure

Percentage of patients who did not undergo surgical mitral valve repair or replacement after the index MitraClip procedure

Percentage of patients who did not undergo surgical mitral valve repair or replacement after the index MitraClip procedure

Mitral Valve Repair Success defined as freedom from mitral valve replacement surgery for valve dysfunction, death, re-operation and MR > 2+ at 12 months.

Freedom from mitral valve replacement surgery for Valve Dysfunction, death, re-operation, and MR > 2+.

Defined as all causes of death for the primary safety Major Adverse Event (MAE) Endpoint. Death is further divided into 2 categories:

A. Cardiac death is defined as death due to any of the following:

1. Acute myocardial infarction.
2. Cardiac perforation/pericardial tamponade.
3. Arrhythmia or conduction abnormality.
4. Stroke within 30 days of the procedure or stroke suspected of being related to the procedure.
5. Death due to any complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery.
6. Any death for which a cardiac cause cannot be excluded.

B. Non-cardiac death is defined as a death not due to cardiac causes (as defined above).

Kaplan-Meier estimated proportion of patients who are alive and have a mitral regurgitation severity grade of 2+ or less.

Device embolization is defined as bilateral Clip detachment resulting in Clip embolization. Reasons for Clip embolization include leaflet tearing, Clip unlocking, Clip fracture or inadequate Clip placement (i.e., malposition). Not included are any fractures or other failures of the Clip that do not result in Clip detachment from both leaflets.

A single leaflet device attachment (SLDA) is defined as attachment of one mitral valve leaflet to the MitraClip device.

Device embolization is defined as bilateral Clip detachment resulting in Clip embolization. Reasons for Clip embolization include leaflet tearing, Clip unlocking, Clip fracture or inadequate Clip placement (i.e., malposition). Not included are any fractures or other failures of the Clip that do not result in Clip detachment from both leaflets.

A single leaflet device attachment (SLDA) is defined as attachment of one mitral valve leaflet to the MitraClip device.

Device embolization is defined as bilateral Clip detachment resulting in Clip embolization. Reasons for Clip embolization include leaflet tearing, Clip unlocking, Clip fracture or inadequate Clip placement (i.e., malposition). Not included are any fractures or other failures of the Clip that do not result in Clip detachment from both leaflets.

A single leaflet device attachment (SLDA) is defined as attachment of one mitral valve leaflet to the MitraClip device.

Device embolization is defined as bilateral Clip detachment resulting in Clip embolization. Reasons for Clip embolization include leaflet tearing, Clip unlocking, Clip fracture or inadequate Clip placement (i.e., malposition). Not included are any fractures or other failures of the Clip that do not result in Clip detachment from both leaflets.

A single leaflet device attachment (SLDA) is defined as attachment of one mitral valve leaflet to the MitraClip device.

Device embolization is defined as bilateral Clip detachment resulting in Clip embolization. Reasons for Clip embolization include leaflet tearing, Clip unlocking, Clip fracture or inadequate Clip placement (i.e., malposition). Not included are any fractures or other failures of the Clip that do not result in Clip detachment from both leaflets.

A single leaflet device attachment (SLDA) is defined as attachment of one mitral valve leaflet to the MitraClip device.

Number of patients who underwent surgical mitral valve repair or replacement after the index MitraClip procedure.

It is a summary of re-interventions to place an additional MitraClip Device.

Kaplan-Meier estimate of the percentage of patients who are alive and did not undergo surgical mitral valve repair or replacement after the index MitraClip procedure

Kaplan-Meier estimate of the percentage of patients who are alive and did not undergo surgical mitral valve repair or replacement after the index MitraClip procedure

Kaplan-Meier estimate of the percentage of patients who are alive and did not undergo surgical mitral valve repair or replacement after the index MitraClip procedure

Kaplan-Meier estimate of the percentage of patients who are alive and did not undergo surgical mitral valve repair or replacement after the index MitraClip procedure

Kaplan-Meier estimate of the percentage of patients who are alive and did not undergo surgical mitral valve repair or replacement after the index MitraClip procedure

Defined as how often patients receiving surgery required replacement of the mitral valve.

Defined as how often patients receiving surgery required replacement of the mitral valve.

Defined as how often patients receiving surgery required replacement of the mitral valve.

Defined as how often patients receiving surgery required replacement of the mitral valve.

The Society of Thoracic Surgeons' risk models predict the risk of operative mortality & morbidity after adult cardiac surgery.

Risk models were developed for nine specific endpoints, including operative mortality.Operative mortality includes both (1) all deaths occurring during the hospitalization, even if after 30 days (2) deaths occurring after discharge, but within 30 days of the procedure.

Therefore, a patient's mortality risk score is defined as the patient's predicted risk of operative mortality as calculated by the specific operative mortality statistical model.

The SF-36 is a multidimensional, patient-reported survey containing 36 questions on a 0-100 scale measuring physical (Physical Component Score PCS) & mental health status (Mental Component Score MCS) in relation to 8 health concepts: physical functioning, role limitations due to physical or emotional health, bodily pain, general health perceptions, vitality, social functioning, & general mental health. Higher scores represent better self-perceived health. The PCS & MCS norms for 65-75 year olds are 44 and 52, while the norms for CHF population are 31 and 46, respectively.

Class I: Patients with cardiac disease but without resulting limitations of physical activity.

Class II: Patients with cardiac disease resulting in slight limitation of physical activity. Patients are comfortable at rest.

Class III: Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest.

Class IV: Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or anginal syndrome may be present even at rest & discomfort is increased with physical activity.

Kaplan-Meier estimated percentage of patients who are alive and have a mitral regurgitation severity grade of 2+ or less

The major effectiveness endpoint is an assessment of multiple functional and structural measures of benefit including New York Heart Association (NYHA) Class.

Class I: Patients with cardiac disease but without resulting limitations of physical activity.

Class II: Patients with cardiac disease resulting in slight limitation of physical activity. Patients are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain.

Class III: Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary physical activity causes fatigue, palpitation dyspnea, or anginal pain.

Class IV: Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased.

71 out of 78 patients (at baseline) were analyzed at 30 days. There were 6 deaths prior to 30 days. So, NYHA at 30 days is missing due to death in 6 patients, and missing due to other reasons in 1 patient.

Class I: Patients with cardiac disease but without resulting limitations of physical activity.

Class II: Patients with cardiac disease resulting in slight limitation of physical activity. Patients are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain.

Class III: Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary physical activity causes fatigue, palpitation dyspnea, or anginal pain.

Class IV: Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased.

Of 78 total population, 54 participants were included in the analysis population because of 18 deaths within 1 year, 3 withdrawals, 1 missed visit and 2 patients without NYHA Class assessment.

Standardized quality of life surveys allow physicians to evaluate the effectiveness of different treatment methods and the physical and psychological benefits a patient is likely to receive from a particular treatment.In the EVEREST II HRR,the patients were asked to complete the SF-36 QOL survey at baseline, 30 days and 12 months. The physical & mental function were assessed by the Physical Component Summary (PCS) score & Mental Component Summary (MCS) score. The PCS & MCS norms for 65-75 year olds are 44 and 52 respectively; and 31 & 46 for congestive heart failure (CHF) patients respectively. Each scale from the SF-36 is an algebraic sum of responses for all items in that scale.For ease of analysis each scale is then transformed to a 0-100 scale using a formula that converts the lowest & highest possible scores to 0 & 100 respectively.The scoring of the SF-36 indicates that 0% in a domain represents the poorest possible QoL & 100% indicates full QoL.

The number of participants analyzed includes subjects who had available follow up data at that time frame.

Left Ventricular End Diastolic Volume (LVEDV) as determined by the core echocardiography laboratory from a transthoracic echocardiogram (TTE).

Of 78 total population, 54 participants were included in the analysis population because of 18 deaths within 1 year, 3 withdrawals, 1 missed visit and LVEDV was not done or un-evaluable in 2 patients.

Left Ventricular End Systolic Volume (LVESV) as determined by the core echocardiography laboratory from a transthoracic echocardiogram (TTE).

Of 78 total population, 54 participants were included in the analysis population because of 18 deaths within 1 year, 3 withdrawals, 1 missed visit and LVESV was not done or un-evaluable in 2 patients.

Left Ventricular Internal Dimension in diastole (LVIDd) and Left Ventricular Internal Dimension in systole (LVIDs) as determined by the core echocardiography laboratory from a transthoracic echocardiogram (TTE).

Of 78 total population, 54 participants were included in the analysis population because of 18 deaths within 1 year, 3 withdrawals, 1 missed visit and LIVDs/LVIDs evaluation was not done or un-evaluable in 2 patients.

Number of patients with incidence of re-hospitalizations for CHF in the 12-months after the MitraClip implant procedure.

Three patients died before discharge and thus do not provide data on post-discharge hospitalizations.

Incidence of re-hospitalizations for CHF in the 12-months after the MitraClip implant procedure.

Three patients died before discharge and thus do not provide data on post-discharge hospitalizations.

Left Ventricular End Diastolic Volume (LVEDV) as determined by the core echocardiography laboratory from a transthoracic echocardiogram (TTE).

Left Ventricular End Systolic Volume (LVESV) as determined by the core echocardiography laboratory from a transthoracic echocardiogram (TTE).

Left Ventricular Internal Dimension in diastole (LVIDd) and Left Ventricular Internal Dimension in systole (LVIDs) as determined by the core echocardiography laboratory from a transthoracic echocardiogram (TTE).

Combined clinical endpoint of death, myocardial infarction, reoperation for failed surgical repair or replacement, nonelective cardiovascular surgery for adverse events, stroke, renal failure, deep wound infection, ventilation for greater than 48 hours, GI complication requiring surgery, new onset of permanent atrial fibrillation, septicemia, and transfusion of 2 or more units of blood.

Combined clinical endpoint of death, myocardial infarction, reoperation for failed surgical repair or replacement, nonelective cardiovascular surgery for adverse events, stroke, renal failure, deep wound infection, ventilation for greater than 48 hours, GI complication requiring surgery, new onset of permanent atrial fibrillation, septicemia, and transfusion of 2 or more units of blood.

Percutaneous Clip procedure or surgery with no occurrence of in-hospital MAE.

Combined clinical endpoint of death, myocardial infarction, reoperation for failed surgical repair or replacement, nonelective cardiovascular surgery for adverse events, stroke, renal failure, deep wound infection, ventilation for greater than 48 hours, GI complication requiring surgery, new onset of permanent atrial fibrillation, septicemia, and transfusion of 2 or more units of blood.

Analysis population includes 48 patients who were aged 75 years or older in the study.

Combined clinical endpoint of death, myocardial infarction, reoperation for failed surgical repair or replacement, nonelective cardiovascular surgery for adverse events, stroke, renal failure, deep wound infection, ventilation for greater than 48 hours, GI complication requiring surgery, new onset of permanent atrial fibrillation, septicemia, and transfusion of 2 or more units of blood.

Analysis population includes 48 patients who were aged 75 years or older in the study.

Defined as the occurrence of any of the following resulting from the index procedure:

• Hematoma at access site >6 cm;
• Retroperitoneal hematoma;
• Arterial-venous fistula;
• Symptomatic peripheral ischemia/ nerve injury with clinical signs or symptoms lasting >24 hours;
• Vascular surgical repair at catheter access sites;
• Pulmonary embolism;
• Ipsilateral deep vein thrombus; or
• Access site-related infection requiring intravenous antibiotics and/or extended hospitalization.

Defined as the occurrence of any of the following resulting from the index procedure:

• Hematoma at access site >6 cm;
• Retroperitoneal hematoma;
• Arterial-venous fistula;
• Symptomatic peripheral ischemia/ nerve injury with clinical signs or symptoms lasting >24 hours;
• Vascular surgical repair at catheter access sites;
• Pulmonary embolism;
• Ipsilateral deep vein thrombus; or
• Access site-related infection requiring intravenous antibiotics and/or extended hospitalization.

Defined as procedure related bleeding that requires a transfusion of ≥2 units of blood and/or surgical intervention.

Defined as procedure related bleeding that requires a transfusion of ≥2 units of blood and/or surgical intervention.

Defined as any mural thrombus or thromboembolism in the vasculature (excluding central nervous system events) confirmed by standard clinical and laboratory testing and which requires intervention.

Defined as any mural thrombus or thromboembolism in the vasculature (excluding central nervous system events) confirmed by standard clinical and laboratory testing and which requires intervention.

Evidence of formation of an independently moving thrombus on any part of the Clip or any commercially available implant used during surgery by echocardiography or fluoroscopy. If Clip is explanted or an autopsy is performed this diagnosis should be confirmed.

Evidence of formation of an independently moving thrombus on any part of the Clip or any commercially available implant used during surgery by echocardiography or fluoroscopy. If Clip is explanted or an autopsy is performed this diagnosis should be confirmed.

Defined as new onset of anemia associated with laboratory evidence of red cell destruction. Diagnosed when plasma free hemoglobin is greater than 40 mg/dL on two measures within 24 hours or on one measure if intervention is initiated based on other clinical symptoms

Defined as new onset of anemia associated with laboratory evidence of red cell destruction. Diagnosed when plasma free hemoglobin is greater than 40 mg/dL on two measures within 24 hours or on one measure if intervention is initiated based on other clinical symptoms.

Includes all new onset atrial fibrillation and heart block requiring placement of a permanent pacemaker.

Includes all new onset atrial fibrillation and heart block requiring placement of a permanent pacemaker.

Using Duke Criteria, endocarditis can be confirmed by:

Pathological criteria: Endocarditis is confirmed if microorganisms are identified by culture or histology in a vegetation, embolized vegetation, or an intracardiac abscess; or if pathological lesions are observed & histologically confirmed showing active endocarditis.

Clinical criteria: Endocarditis is confirmed by the presence of 2 major criteria, 1 major plus 3 minor criteria, or 5 minor criteria. Major criteria include persistently +ve blood cultures with the presence of typical organisms for endocarditis; persistent bacteremia; evidence of endocardial involvement with positive echocardiogram with signs of oscillating vegetation, abscesses, valve perforation, new partial dehiscence of prosthetic valve or new valvular regurgitation. Minor criteria include predisposing heart condition, fever, vascular phenomena, immunologic phenomena, & positive blood culture or echocardiogram not meeting major criteria.

Using Duke Criteria, endocarditis can be confirmed by:

Pathological criteria: Endocarditis is confirmed if microorganisms are identified by culture or histology in a vegetation, embolized vegetation, or an intracardiac abscess; or if pathological lesions are observed & histologically confirmed showing active endocarditis.

Clinical criteria: Endocarditis is confirmed by the presence of 2 major criteria, 1 major plus 3 minor criteria, or 5 minor criteria.

Major criteria include persistently +ve blood cultures with the presence of typical organisms for endocarditis; persistent bacteremia; evidence of endocardial involvement with positive echocardiogram with signs of oscillating vegetation, abscesses, valve perforation, new partial dehiscence of prosthetic valve or new valvular regurgitation.

Minor criteria include predisposing heart condition, fever, vascular phenomena, immunologic phenomena, & positive blood culture or echocardiogram not meeting major criteria.

Occurrence of clinically significant ASD as a result of the procedure requiring intervention.

Occurrence of clinically significant ASD as a result of the procedure requiring intervention.

Mitral stenosis associated with a total mitral valve orifice area less than 1.5 cm2.

Of total 78 participants, only 72 participants were analyzed as 6 deaths within 30 days.

Mitral stenosis associated with a total mitral valve orifice area less than 1.5 cm2.

Of total 78 participants, only 72 participants were analyzed because 3 patients were not implanted with a device and 3 patients died prior to discharge.

Mitral stenosis associated with a total mitral valve orifice area less than 1.5 cm2.

Mitral stenosis associated with a total mitral valve orifice area less than 1.5 cm2.

Mitral stenosis associated with a total mitral valve orifice area less than 1.5 cm2.

Mitral valve area as measured by core lab echocardiography.

Of 78 total population, 50 participants were included in analysis population because of 6 deaths and Mitral Valve Area by planimetry was not done in 22 patients.

Mitral valve area as measured by core lab echocardiography.

Of 78 total population, 45 participants were included in analysis population because of 18 deaths within 1 year, 3 withdrawals, 1 missed visit and in 11 patients Mitral valve area evaluation was not done or un-evaluable.

Mitral valve area as measured by core lab echocardiography.