Assessment of the St Jude Medical Portico Resheathable Aortic Valve System-Alternative Access

Major Vascular complication is defined as

• Any aortic dissection, aortic rupture, annulus rupture, left ventricle perforation, or new apical aneurysm/pseudo-aneurysm or
• Access site or access-related vascular injury leading to death, life-threatening or major bleeding, visceral ischaemia or neurological impairment or
• Distal embolization from a vascular source requiring surgery or resulting in amputation or irreversible end-organ damage or
• The use of unplanned endovascular or surgical intervention associated with death, major bleeding, visceral ischaemia or neurological impairment or
• Any new ipsilateral lower extremity ischemia documented by patient symptoms, physical exam, and/or decreased or absent blood flow on lower extremity angiogram or
• Surgery for access site-related nerve injury or
• Permanent access site-related nerve injury

Any 1 of the following criteria:

• Death due to proximate cardiac cause (e.g., myocardial infarction, cardiac tamponade, worsening heart failure)
• Death caused by non-coronary vascular conditions such as neurological events, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular disease.
• All procedure-related deaths, including those related to a complication of the procedure or treatment for a complication of the procedure
• All valve-related deaths including structural or nonstructural valve dysfunction or other valve-related adverse events
• Sudden or unwitnessed death
• Death of unknown cause

Any 1 of the following criteria:

• Death due to proximate cardiac cause (e.g., myocardial infarction, cardiac tamponade, worsening heart failure)
• Death caused by non-coronary vascular conditions such as neurological events, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular disease.
• All procedure-related deaths, including those related to a complication of the procedure or treatment for a complication of the procedure
• All valve-related deaths including structural or nonstructural valve dysfunction or other valve-related adverse events
• Sudden or unwitnessed death
• Death of unknown cause

Disabling stroke is an mRS score of 2 or more at 90 days and an increase of at least 1 mRS category from an individual's prestroke baseline

Disabling stroke is an mRS score of 2 or more at 90 days and an increase of at least 1 mRS category from an individual's prestroke baseline

Non-disabling is an mRS score of <2 at 90 days or 1 that does not result in an increase of at least 1 mRS category from an individual's prestroke baseline

Non-disabling is an mRS score of <2 at 90 days or 1 that does not result in an increase of at least 1 mRS category from an individual's prestroke baseline

Life threatening bleeding requiring transfusion

• Overt bleeding either associated with a drop in the hemoglobin level of at least 3.0 g/dL or requiring transfusion of 2 or 3 units of whole blood/RBC, or causing hospitalization or permanent injury, or requiring surgery AND
• Does not meet criteria of life-threatening or disabling bleeding

Life threatening bleeding requiring transfusion

• Overt bleeding either associated with a drop in the hemoglobin level of at least 3.0 g/dL or requiring transfusion of 2 or 3 units of whole blood/RBC, or causing hospitalization or permanent injury, or requiring surgery AND
• Does not meet criteria of life-threatening or disabling bleeding

Increase in serum creatinine to greater than or equal to 300% (3 X increase compared with baseline) or serum creatinine of ≥ 4.0 mg/dL (354 mmol/L) with an acute increase of at least 0.5 mg/dL (44 mmol/L)or Urine output <0.3 mL/kg per hour for ≥24 hours or anuria for ≥12 hours. Patients receiving renal replacement therapy are considered to meet Stage 3 criteria irrespective of other criteria

Increase in serum creatinine to greater than or equal to 300% (3 X increase compared with baseline) or serum creatinine of ≥ 4.0 mg/dL (354 mmol/L) with an acute increase of at least 0.5 mg/dL (44 mmol/L)or Urine output <0.3 mL/kg per hour for ≥24 hours or anuria for ≥12 hours. Patients receiving renal replacement therapy are considered to meet Stage 3 criteria irrespective of other criteria

Stroke is an acute symptomatic episode of neurological dysfunction attributed to a vascular cause.

Transient Ischemic Attack (TIA) is a transient (less than 24 hrs) episode of neurological dysfunction caused by focal brain, spinal cord, or retinal ischemia, without acute infarction. No evidence of infarction if imaging performed.

Encephalopathy is defined as altered mental state (e.g., seizures, delirium, confusion, hallucinations, dementia, coma, psychiatric episode).

Stroke is an acute symptomatic episode of neurological dysfunction attributed to a vascular cause.

Transient Ischemic Attack (TIA) is a transient (less than 24 hrs) episode of neurological dysfunction caused by focal brain, spinal cord, or retinal ischemia, without acute infarction. No evidence of infarction if imaging performed.

Encephalopathy is defined as altered mental state (e.g., seizures, delirium, confusion, hallucinations, dementia, coma, psychiatric episode).

New York Heart Association (NYHA) functional classification provides a way of classifying the extent of heart failure. It places patients in one of four categories based on how much they are limited during physical activity; the limitations/symptoms are in regard to normal breathing and varying degrees in shortness of breath and/or angina pain.

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

Class II. Patients with cardiac disease resulting in slight limitation of physical activity. They 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 heart failure or the anginal syndrome may be present even at rest.

The Six Minute Walk Test (6MWT)measures the distance that a patient can walk in a period of 6 minutes. The distance walked is measured in meters. This test measures the patients' functional status. The more meters a patient can walk over baseline indicates improvement in functional status.

Effective Orifice Area of the prosthetic valve measured via echocardiography to determine physiological area of blood flow through the valve.

Acute device success is defined as a subject who achieves a) successful vascular access, delivery and deployment of the device and successful retrieval of the delivery system, b) correct position of the device in the proper anatomical location, c) intended performance of the prosthetic heart valve, and d) only 1 valve implanted in the proper anatomical location.

Device success is a 'technical' composite endpoint meant to characterize the acute device and procedural factors which underlie vascular access, delivery, and performance of the TAVI system. Echocardiography should be routinely utilized as the standard for measuring prosthetic valve stenosis and regurgitation immediately after TAVI, and should always be performed in a resting state, either within 24-48 h after the index procedure or before hospital discharge.