Active Post-Market Surveillance of Innovative Devices for Valvular Heart Disease

Neurologic events are defined according to VARC-3 criteria, including ischaemic stroke, haemorrhagic stroke, and Transient ischaemic attack (TIA):

Ischaemic Stroke: Acute focal neurologic deficit in a vascular territory with symptoms ≥ 24h OR < 24h with neuroimaging (CT or MRI) or pathology confirmation of CNS infarction.

Haemorrhagic Stroke: Acute neurologic deficit due to non-traumatic intracranial hemorrhage, confirmed by neuroimaging (CT or MRI) or pathology.

TIA: Transient focal neurologic deficit < 24h presumed to be ischaemic, but without evidence of acute infarction on neuroimaging (CT or MRI) or pathology.

Bleeding events are defined according to VARC-3 criteria:

Type 1 (Minor): Overt bleeding that does not require intervention but leads to hospitalization, increased level of care, or medical evaluation, or requires a transfusion of 1 unit of whole blood or red blood cells.

Type 2 (Major): Overt bleeding that requires a transfusion of 2 to 4 units of whole blood or red blood cells, or is associated with a hemoglobin drop of 3 to 5 g/dL.

Type 3 (Life-threatening or Disabling): Overt bleeding in a critical organ (e.g., intracranial, pericardial with tamponade), causing hypovolemic shock or severe hypotension requiring vasopressors or surgery, or requiring a transfusion of ≥ 5 units of whole blood or red blood cells, or associated with a hemoglobin drop ≥ 5 g/dL.

Type 4 (Fatal): Overt bleeding leading to death, classified as probable based on clinical suspicion or definite if confirmed by autopsy or neuroimaging.

Technical success is defined according to VARC-3 criteria, requiring the fulfillment of the following:

• Freedom from mortality.
• Successful access, delivery of the device, and retrieval of the delivery system.
• Correct positioning of a single prosthetic heart valve into the proper anatomical location.
• Freedom from surgery or intervention related to the device, or to a major vascular, access-related, or cardiac structural complication.

Device success is defined according to VARC-3 criteria, requiring the fulfillment of the following:

• Technical success
• Freedom from mortality
• Freedom from surgery or intervention related to the device or to a major vascular or access-related or cardiac structural complication
• Intended performance of the valve

Taking the Transcatheter Aortic Valve Replacement cohort as an example, early safety is defined according to VARC-3 criteria, requiring the fulfillment of the following:

• Freedom from all-cause mortality
• Freedom from all stroke
• Freedom from VARC type 2-4 bleeding
• Freedom from major vascular, access-related, or cardiac structural complication
• Freedom from acute kidney injury stage 3 or 4
• Freedom from moderate or severe aortic regurgitation
• Freedom from new permanent pacemaker due to procedure-related conduction abnormalities
• Freedom from surgery or intervention related to the device

Taking the Transcatheter Aortic Valve Replacement cohort as an example, clinical efficacy is defined according to VARC-3 criteria, requiring the fulfillment of the following:

• Freedom from all-cause mortality
• Freedom from all stroke
• Freedom from hospitalization for procedure- or valve-related causes
• Freedom from KCCQ Overall Summary Score <45 or decline from baseline of >10 point

Class I, II, III, or IV