Heterotopic Implantation Of the Edwards-Sapien Transcatheter Aortic Valve in the Inferior VEna Cava for the Treatment of Severe Tricuspid Regurgitation (HOVER)

Measure of improvement in lower extremity (LE) edema measured by the Villalta Scale. The Villalta Scale is used to assess patients with lower extremity signs and symptoms of swelling, discoloration, or ulceration. The scale evaluates 5 patient reported items (pain, cramps, heaviness, paresthesia, pruritus) and 6 clinician-observed items (pretibial edema, skin induration, hyperpigmentation, pain during calf compression, venous ectasia, redness). Each item is graded on a four-point scale (0=none, 1=mild, 2=moderate, 3=severe). All points are added, resulting in an overall score from 0 to 33. The final Villalta score of 5-9 is mild disease, 10-14 is moderate, and ≥15 is severe disease. A 3.1 point reduction in this scale between time points is associated with improved quality of life.

Occurrence of stroke or transient ischemic attack (TIA) by Valve Academic Research Consortium (VARC-2) criteria. VARC-2 diagnostic criteria defines stroke as a duration of a focal or global neurological deficit ≥ 24 hours; OR <24 hours if available neuroimaging documents a new hemorrhage or infarct; OR the neurological deficit results in death. VARC-2 diagnostic criteria defines TIA as a duration of a focal or global neurological deficit <24 hours, any variable neuroimaging does not demonstrate a new hemorrhage or infarct.

Mortality by Valve Academic Research Consortium (VARC-2) criteria. VARC-2 criteria separate All-cause mortality into 'Cardiovascular mortality' and 'Noncardiovascular mortality'. Cardiovascular mortality is defined as any of the following criteria: Death due to proximate cardiac cause (eg, myocardial infarction, cardiac tamponade, worsening heart failure); Death caused by noncoronary 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. Noncardiovascular mortality is defined as any death in which the primary cause of death is clearly related to another condition (eg, trauma, cancer, suicide)

Myocardial Infarction (MI) by Valve Academic Research Consortium (VARC-2) criteria. VARC-2 defines MI as either periprocedural MI (new ischemic symptoms or signs AND elevated cardiac biomarkers within 72 hours after the index procedure), or spontaneous MI (>72hours after the index procedure, any 1 of the following: detection of rise and/or fall of cardiac biomarkers with at least 1 value above the 99th percentile, together with the evidence of myocardial ischemia with either symptoms of ischemia, ECG changes indicative of new ischemia, new pathological Q-waves in at least two contiguous leads, or imaging evidence of a new loss of viable myocardium or new wall motion abnormality; Sudden, unexpected cardiac death involving cardiac arrest, accompanied by new ST elevation or new LBBB, and/or evidence of fresh thrombus by coronary angiogram or at autopsy, or at a time before the appearance of cardiac biomarker in the blood; or Pathological findings of an acute MI).

Occurrence of Acute Kidney Injury (AKI) by Valve Academic Research Consortium (VARC-2) criteria. VARC-2 criteria defines AKI as any of the following: [Stage 1] Increase in serum creatinine to 150-199% OR Urine output <0.5mL/kg/h for >6 but <12hours; [Stage 2] Increase in serum creatinine to 200-299% OR Urine output <0.5 mL/kg/h for >6 but <12hours; or [Stage 3] Increase in serum creatinine to ≥300% OR Urine output <0.3mL/kg/h for ≥24hours OR Anuria for ≥12hours.

Major Vascular Complications by Valve Academic Research Consortium (VARC-2) criteria. VARC-2 defines major vascular complications as: any aortic dissection aortic rupture, annulus rupture, left ventricle perforation, or new apical aneurysm/pseudoaneurysm; Access site or access-related vascular injury leading to death, life threatening or major bleeding, visceral ischemia, or neurological impairment; Distal embolization from a vascular source requiring surgery or resulting in amputation or irreversible end-organ damage; The use of unplanned endovascular or surgical intervention associated with death, major bleeding, visceral ischemia or neurological impairment; Any new ipsilateral lower extremity ischemia documented by patient symptoms, physical exam, and/or decreased or absent blood flow on lower extremity angiogram; surgery for access site-related nerve injury; or Permanent access site-related nerve injury.