Rivet PVS Therapy in Group 2 PH-HFpEF

Select Inclusion Criteria:

Age ≥ 18 years

Prior diagnosis of Group 2 PH due to HFpEF, with the following resting hemodynamic criteria confirmed in the past year by right heart catheterization

a. mPAP ≥ 25 mmHg at rest or mPAP/CO slope > 3 mmHg/L/min during incremental exercise

Confirmation of the following hemodynamic criteria during supine exercise

a. PCWP ≥ 25 mmHg, or PCWP/CO slope > 2 mmHg/L/min

Chronic symptomatic heart failure documented by the following:

NYHA HF Class II with history > II, or Class III, or ambulatory Class IV
≥ 1 HF hospitalization, or healthcare facility with IV diuretics or intensification of oral diuresis for HF within 12 months, or NT-pro BNP value > 400 pg/mL in normal sinus rhythm or > 750 pg/mL in atrial fibrillation in past 6 months
Ongoing stable guideline directed medical therapy (GDMT) for HF and medically optimized per treating HF physician according to current ACCF/AHA guidelines that is expected to be maintained without change for 6 months (excluding diuretic dosage changes for HF optimization within 90 days of the Index Procedure)
6MWD ≥ 150 m

Select 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

Greater than moderate RV dysfunction as assessed by TTE and/or MRI
RV FAC < 35%
TAPSE < 14 mm via TTE
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:

ACC/AHA/ESC Stage D heart failure, non-ambulatory NYHA Class IV HF
If BMI < 30, Cardiac Index < 2.0 L/min/m2
If BMI ≥ 30, Cardiac Index < 1.8 L/min/m2
Requires continuous intravenous inotropic infusion
Requires mechanical circulatory support
Currently on the cardiac transplant waiting list

Chronic renal dysfunction defined as one or more of the following:

Currently requiring dialysis; OR
eGFR < 35 mL/min/1.73 m2 by the CKD-Epi equation

Chronic pulmonary disease defined as one or more of the following:

Requires continuous home oxygen therapy
Recent hospitalization for exacerbation within 12 months prior to screening
FEV1 < 50% predicted