Rivet PVS Therapy in Group 2 PH-HFpEF

Exclusion Criteria

• •Any therapeutic intracardiac intervention within the last 30 days
• •PH Group 1, 3, 4 or 5
• •Mean RAP \>12 mmHg by RHC at rest on room air
• •Right ventricular dysfunction, defined as one or more of the following
• •1. Greater than moderate RV dysfunction as assessed by TTE and/or MRI
• •2. RV FAC \< 35%
• •3. TAPSE \< 14 mm via TTE
• •4. RV size severely enlarged compared to LV size as estimated by TTE and/or MRI
• •Severe tricuspid valve regurgitation
• •Peak systolic pulmonary arterial pressure \> 80 mmHg by RHC at rest while awake
• •Mean pulmonary arterial pressure \> 50 mmHg by RHC at rest while awake
• •PVR \> 6 Wood units at rest while awake on room air or exercise PVR \> 2 Wood Units
• •Left ventricular ejection fraction \< 50%
• •Severe heart failure, defined as one or more of the following:
• •1. ACC/AHA/ESC Stage D heart failure, non-ambulatory NYHA Class IV HF
• •2. If BMI \< 30, Cardiac Index \< 2.0 L/min/m2
• •3. If BMI ≥ 30, Cardiac Index \< 1.8 L/min/m2
• •4. Requires continuous intravenous inotropic infusion
• •5. Requires mechanical circulatory support
• •6. Currently on the cardiac transplant waiting list
• •Chronic renal dysfunction defined as one or more of the following:
• •1. Currently requiring dialysis; OR
• •2. eGFR \< 35 mL/min/1.73 m2 by the CKD-Epi equation
• •Chronic pulmonary disease defined as one or more of the following:
• •1. Requires continuous home oxygen therapy
• •2. Recent hospitalization for exacerbation within 12 months prior to screening
• •3. FEV1 \< 50% predicted