Indication |
HFpEF and HFmrEF |
HFpEF, HFmrEF and HFrEF |
HFpEF, HFmrEF and HFrEF |
Trial |
REDUCE LAP-HF II, 2022 |
V-WAVE SHUNT (VW-SP-1), 2018 |
AFR PRELIEVE, 2021 |
Methods and Demographic data |
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- double-blinded RCT, sham-controlled
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- n=626. IASD (n=314) and sham (n=312), FU= 24 months
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- Inclusion: EF ≥ 40%, NYHA II- III, (PCWP) ≥ 25mmHg (exercise)
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- Patients: 72 y.o., NYHA III (77%), mean EF: 60%, female sex (62%)
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- first-in-man, n=38, 6 centers, FU=12 months.
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- Inclusion: EF >15%, NYHA III-IVa
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- Patients: 66 y.o., ischemic cardiomyopathy (79%), NYHA III (97%), 79% with HFrEF (mean EF: 26%) and 21% with HFpEF (mean EF: 50%), male sex (92%)
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- first-in-man , n=53, multicentric, FU=12 months
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- Inclusion: EF > 15%, NYHA III-IVa, PCWP ≥ 25 (exercise) ou ≥15 (rest)
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- Patients: 70 y.o., NYHA III (93%), HFrEF (n=24), HFpEF (n=29)
|
Results |
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- no difference in the 1ª EP of CV death, non-fatal ischemic stroke at 12 months
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- IASD did not reduce HF-related events or improve quality of life
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- NYHA significantly improved in the shunt group.
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- improvement in NYHA, quality of life and 6MWT
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- in 12 months: occluded shunts (14%) and stenotic shunts (36%)
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- in those with a patent shunt at 12 months, there was less hospitalization due to HF (p= 0.008) and a reduction in PCWP (p= 0.01)
|
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- success rate: 98%
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- improvement in NYHA, quality of life and 6MWT
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- shunt patency at 12 months: 100%
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- hospitalizations due to HF: 6/53 (3 HFrEF and 3 HFpEF) - total deaths: 3 (all HFrEF)
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Additional Data |
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REDUCE LAP-HF I (2016):
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- n=64, NYHA II-IV, EF ≥ 40%, FU=12 months
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- reduction of iLVEdV, increase in iRVEdV, reduction in PCWP
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- improvement in NYHA, quality of life and 6MWT
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RELIEVE-HF: (in progress)
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- n=605, RCT, double-blind
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- randomization 1:1
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- FU: 1, 2 e 5 years
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- 3-month FU: reduction in PCWP (p= 0.0003)
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- 1y FU: no shunt occlusion, stroke, or new HF was observed, with clinical improvements in certain patients
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Size / Caliber |
8 mm / 16 Fr |
5 mm / 14 Fr |
6, 8, and 10 mm / 12-14 Fr |
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