Feasibility of a No-Implant Approach to Interatrial Shunts: Preclinical and Early Clinical Studies

Barker, Colin M.; Meduri, Christopher; Fail, Peter S.; Chambers, Jeffrey W.; Solet, Darrell J.; Kriegel, Jacob M.; Vela, Deborah; Feldt, Kari; Pate, Thomas D.; Patel, Avni; Shaburishvili, Tamaz

doi:10.1016/j.shj.2022.100078

Cited by 6 publications

(2 citation statements)

References 26 publications

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“…Increased left atrial pressure leading to pulmonary congestion is the most common mechanism precipitating worsening symptoms and acute decompensation. Interatrial shunt devices are under development for decompressing the left atrium in patients with HF 2–8 . The REducing Lung congestIon symptoms using the v‐wavE shunt in adVancEd Heart Failure (RELIEVE‐HF) trial (http://clinicaltrials.gov NCT03499236) 9 is a Food and Drug Administration Investigational Device Exemption, multicentre pivotal study of the V‐Wave Ventura® Interatrial Shunt in symptomatic HF patients, regardless of left ventricular ejection fraction (LVEF).…”

Section: Introductionmentioning

confidence: 99%

“…Interatrial shunt devices are under development for decompressing the left atrium in patients with HF. [2][3][4][5][6][7][8] The REducing Lung congestIon symptoms using the v-wavE shunt in adVancEd Heart Failure (RELIEVE-HF) trial (ClinicalTrials.gov NCT03499236) 9 is a Food and Drug Administration Investigational Device Exemption, multicentre pivotal study of the V-Wave Ventura ® Interatrial Shunt in symptomatic HF patients, regardless of left ventricular ejection fraction (LVEF). Two parallel patient cohorts have been recruited: (1) a randomized, double-blind, sham-controlled cohort of 508 patients awaiting completion of primary follow-up, and (2) a prospective, open-label, treatment only roll-in cohort of 97 subjects to assess learning curve and early safety issues.…”

Section: Introductionmentioning

confidence: 99%

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Interatrial shunt therapy in advanced heart failure: Outcomes from the open‐label cohort of the RELIEVE‐HF trial

Rodés‐Cabau,

Lindenfeld,

Abraham

et al. 2024

European J of Heart Fail

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AimsHeart failure (HF) outcomes remain poor despite optimal guideline‐directed medical therapy (GDMT). We assessed safety, effectiveness, and transthoracic echocardiographic (TTE) outcomes during the 12 months after Ventura shunt implantation in the RELIEVE‐HF open‐label roll‐in cohort.Methods and resultsEligibility required symptomatic HF despite optimal GDMT with ≥1 HF hospitalization in the prior year or elevated natriuretic peptides. The safety endpoint was device‐related major adverse cardiovascular or neurological events at 30 days, compared to a prespecified performance goal. Effectiveness evaluations included the Kansas City Cardiomyopathy Questionnaire (KCCQ) at baseline, 1, 3, 6, and 12 months and TTE at baseline and 12 months. Overall, 97 patients were enrolled and implanted at 64 sites. Average age was 70 ± 11 years, 97% were in New York Heart Association class III, and half had left ventricular ejection fraction (LVEF) ≤40%. The safety endpoint was achieved (event rate 0%, p < 0.001). KCCQ overall summary score was improved by 12–16 points at all follow‐up timepoints (all p < 0.004), with similar outcomes in patients with reduced and preserved LVEF. At 12 months, left ventricular end‐systolic and end‐diastolic volumes were reduced (p = 0.020 and p = 0.038, respectively), LVEF improved (p = 0.009), right ventricular end‐systolic and end‐diastolic areas were reduced (p = 0.001 and p = 0.030, respectively), and right ventricular fractional area change (p < 0.001) and tricuspid annular plane systolic excursion (p < 0.001) improved.ConclusionInteratrial shunting with the Ventura device was safe and resulted in favourable clinical effects in patients with HF, regardless of LVEF. Improvements of left and right ventricular structure and function were consistent with reverse myocardial remodelling. These results would support the potential of this shunt device as a treatment for HF.

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Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Interatrial shunt therapy in advanced heart failure: Outcomes from the open‐label cohort of the RELIEVE‐HF trial

Rodés‐Cabau,

Lindenfeld,

Abraham

et al. 2024

European J of Heart Fail

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In vivo fluid dynamics of the Ventura interatrial shunt device in patients with heart failure

Pfeiffer,

Boehmer,

Gorcsan

et al. 2024

ESC Heart Failure

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AimsInteratrial shunts are under evaluation as a treatment for heart failure (HF); however, their in vivo flow performance has not been quantitatively studied. We aimed to investigate the fluid dynamics properties of the 0.51 cm orifice diameter Ventura shunt and assess its lumen integrity with serial transesophageal echocardiography (TEE).Methods and resultsComputational fluid dynamics (CFD) and bench flow tests were used to establish the flow‐pressure relationship of the shunt. Open‐label patients from the RELIEVE‐HF trial underwent TEE at shunt implant and at 6 and 12 month follow‐up. Shunt effective diameter (Deff) was derived from the vena contracta, and flow was determined by the continuity equation. CFD and bench studies independently validated that the shunt's discharge coefficient was 0.88 to 0.89. The device was successfully implanted in all 97 enrolled patients; mean age was 70 ± 11 years, 97% were NYHA class III, and 51% had LVEF ≤40%. Patency was confirmed in all instances, except for one stenotic shunt at 6 months. Deff remained unchanged from baseline at 12 months (0.47 ± 0.01 cm, P = 0.376), as did the trans‐shunt mean pressure gradient (5.1 ± 3.9 mmHg, P = 0.316) and flow (1137 ± 463 mL/min, P = 0.384). TEE measured flow versus pressure closely correlated (R2 ≥ 0.98) with a fluid dynamics model. At 12 months, the pulmonary/systemic flow Qp/Qs ratio was 1.22 ± 0.12.ConclusionsWhen implanted in patients with advanced HF, this small interatrial shunt demonstrated predictable and durable patency and performance.

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Evaluating the role of interatrial shunt devices in heart failure management: insights from the RELIEVE-HF trial

Sideris,

Liori

2024

Heart Fail Rev

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Feasibility of a No-Implant Approach to Interatrial Shunts: Preclinical and Early Clinical Studies

Cited by 6 publications

References 26 publications

Interatrial shunt therapy in advanced heart failure: Outcomes from the open‐label cohort of the RELIEVE‐HF trial

Interatrial shunt therapy in advanced heart failure: Outcomes from the open‐label cohort of the RELIEVE‐HF trial

In vivo fluid dynamics of the Ventura interatrial shunt device in patients with heart failure

Evaluating the role of interatrial shunt devices in heart failure management: insights from the RELIEVE-HF trial

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