| I. Intraprocedural success |
All of the following must be present:
Absence of intraprocedural mortality or stroke; and Successful access, delivery, and retrieval of the device delivery system; and Successful deployment and correct positioning of the intended device(s) without requiring implantation of unplanned additional devices; and Adequate performance of the transcatheter device. Performance of devices whose purpose is a reduction in TR, should include the absence of tricuspid stenosis (TVA ≥ 1.5 cm2 or TVAi ≥ 0.9 cm2/m2 [ ≥ 0.75 if BMI > 30 kg/m2], DVI < 2.2, mean gradient < 5 mm Hg); reduction of total tricuspid regurgitation to optimal (≤ mild [1+]) or acceptable (≤ moderate [2+]). Absence of device-related obstruction of forward flow Absence of device-related pulmonary embolism Freedom from emergency surgery or reintervention during the first 24 h related to the device or access procedure.
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| II. Clinical success (assessed at 30 d and 1 y) |
All of the following must be present at 30 d:
Absence of procedural mortality or stroke; and Proper position of the device with adequate performance of the transcatheter device. Performance of devices whose purpose is a reduction in TR should include the absence of tricuspid stenosis (TVA ≥ 1.5 cm2 or TVAi ≥ 0.9 cm2/m2 [ ≥ 0.75 if BMI > 30 kg/m2], DVI < 2.2, mean gradient < 5 mm Hg); reduction of total tricuspid regurgitation to optimal (≤ mild [1+]) or acceptable (≤ moderate [2+]); and Freedom from unplanned surgical or interventional procedures related to the device or access procedure; and -
Absence of major device or procedure related serious adverse events, including:
Life-threatening bleeding (TVARC 5) Major vascular complications Major cardiac structural complications Stage 2 or 3 acute kidney injury (includes new dialysis) Myocardial infarction or coronary ischemia requiring percutaneous coronary intervention or coronary artery bypass graft Device-related obstruction of forward flow Device-related pulmonary embolism Any severe hemodynamic compromise leading to heart transplantation or major cardiac assistance or patient extracorporeal membrane oxygenation dependent on day 30 Any valve-related dysfunction, migration, thrombosis, or other complication requiring surgery or repeat intervention
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The following must be present at 1 y:
(5) No rehospitalizations or reinterventions for the underlying condition (eg, tricuspid regurgitation/stenosis, heart failure); and (6) Improvement from baseline in symptoms (eg, NYHA improvement by ≥ 1 functional class); and/or Improvement from baseline in functional status (eg, 6-min walk test improvement by ≥ 50 m); and/or Improvement from baseline in quality-of-life (eg, Kansas City Cardiomyopathy Questionnaire improvement by ≥ 5)
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