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April 6, 2024
4 minute read
Important points:
- Interatrial shunt implants reduced the risk of HF hospitalization in patients with HFrEF compared with placebo.
- However, patients with HFpEF had a more than 3-fold increased risk of all-cause mortality.
ATLANTA — Transcatheter implantation of interatrial shunts has yielded significantly different outcomes depending on ejection fraction in patients with HF, speakers reported at the American College of Cardiology Scientific Sessions.
Shunts reduced the risk of heart failure hospitalization in heart failure patients with decreased EF compared with placebo at 2 years. Greg W. Stone, MDProfessor of Cardiology and Population Health Sciences at the Icahn School of Medicine at Mount Sinai and Dean of Academic Affairs at the Mount Sinai Health System, said in his presentation.
In contrast, in HF patients with preserved EF, shunt implants increased the risk of all-cause mortality by more than 3-fold compared with placebo, and hospitalization for heart failure, according to results from a double-blind randomized placebo study. It increased the risk more than twice. Controlled RELIEVE-HF study.
Greg W. Stone
“Transcatheter implantation of a Ventura interatrial shunt was safe but did not reduce symptoms or improve 2-year prognosis in patients with heart failure across the entire range of left ventricular ejection fractions,” Stone said. He said this during his lecture. “However, the results of a prespecified stratified analysis show that interatrial shunt implantation is beneficial for patients with reduced left ventricular ejection fraction but harmful for patients with preserved LVEF. It suggests.”
In the RELIEVE-HF trial, Stone et al investigated whether implantation of an interatrial shunt (Ventura IAS, V-Wave Ltd.) could improve left atrial pressure, HF symptoms, and prognosis in a cohort of HF patients with varying EF. I rated it. range. Reduced EF was defined as EF less than or equal to 40%, and preserved EF was defined as EF greater than 40%.
The shunt was implanted via a 14-French delivery system, creating a 5.1-mm opening in the fossa ovalis. In the left atrium, expanded polytetrafluoroethylene directs blood flow to the right atrium while preventing lumen loss. In the right atrium, an “exit hood” blocks the passage of paradoxical emboli. Patients who receive shunt implants then receive dual antiplatelet therapy for 6 months.
The primary efficacy endpoints were all-cause mortality, heart transplantation or left ventricular assist device implantation, heart failure hospitalization, all outpatient heart failure worsening events, and Kansas City Cardiomyopathy Questionnaire score from baseline to 12 months. It was a hierarchical composite of changes of a minimum of 5 points.
Primary safety endpoints were device-related or procedural, including all-cause mortality, stroke, systemic embolism, need for open heart surgery, or need for major endovascular surgical repair at 30 days. were associated adverse CV events. The goal for the outpatient treatment component was less than 11%.
A total of 508 patients from 113 centers in 11 countries were randomized to receive either interatrial shunt (mean age 74 years, 65% men) or sham surgery (mean age 72 years, 61% men). Matched 1:1.
The shunts were successfully implanted in all participants, with an average operative time of 80 minutes and an average fluoroscopy time of 14 minutes. His hospital stay after surgery was 1 day in both the shunt and placebo groups.
Over a median follow-up of 22 months, the primary efficacy endpoint did not differ between groups across the cohort (step-weighted win rate, 0.86; 95% CI, 0.61-1.22; 95% CI, 0.61-1.22; 95% CI , 0.61-1.22, 95% CI, 0.61-1.22). P = .2), Stone said during the presentation, and annualized rates of events also did not differ between groups (relative rate ratio = 1; 95% CI, 0.83-1.2; 95% CI, 0.83-1.2; P = .96), as were the proportions for the individual components of the primary efficacy endpoint.
KCCQ scores improved from baseline in both groups, but did not differ between groups for the entire cohort (P = .74), Stone said.
There were no device-related or treatment-related adverse CV events by 30 days or 2 years.
Among patients with HFpEF, those assigned shunts had lower all-cause mortality (RR = 3.24; 95% CI, 1.38-7.59), hospitalization for heart failure (RR = 2.05; 95% CI, 1.35-3.1), and a composite of Significantly increased risk. According to Stone, worsening of all-cause death, heart transplant, LVAD, heart failure hospitalization, and outpatient heart failure events at 2 years (HR = 1.68, 95% CI, 1.29-2.19).
In sharp contrast (P Interatrial shunts in HFrEF patients reduced the risk of HF hospitalization (RR = 0.52; 95% CI, 0.31-0.86) and the combined risk of all-cause mortality and heart transplantation (all interactions < 0.05), compared with placebo LVAD, HF hospitalization and outpatient HF events (HR = 0.55; 95% CI, 0.42-0.73), and a trend toward decreased risk of all-cause mortality (RR = 0.63; 95%) CI, 0.31-1.26).
The interatrial shunt is CE marked and approved for sale in the European Union, but has not yet been approved for commercial use in the United States.
“Our results apply only to the profile of patients enrolled and treated with this particular interatrial shunt. Reduced and preserved ejection fraction groups, prespecified randomized strata They were not individually enriched to increase validity. Therefore, the results within each stratum should be considered exploratory,” Stone said during the presentation. “However, the strong interaction and spline curve analysis of cardiovascular events showing essentially a dose-response curve suggest that these findings are not due to chance. Similar findings between the KCCQ and built-in device control groups The large increase highlights the relevance of the placebo effect and the need for blinded trials.”
reference:
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Stone GW et al. Latest Clinical Trials I. Presented at: American College of Cardiology Academic Session. April 6-8, 2024. Atlanta.
Disclosure: Mr. Stone has received consulting fees and benefits from Abiomed, Ablative Solutions, Adona Medical, Ancora, Apollo Therapeutics, Boehringer Ingelheim, Cardiac Success, Daiichi Sankyo, Elixir, Elucid Bioimaging, Heartflow, HighLife, Impulse Dynamics, Millennia Biopharma, Miracor, and Neovasc. Reports that he/she receives honoraria. , Occlutech, Oxitope, Robocath, TherOx, Valfix, Vectorious. receives an institutional research grant for future testing from Vascular Dynamics; He receives research grants from Abbott, Abiomed, Biosense Webster, bioventrix, Cardiovascular Systems Inc., Phillips, Pulnovo, Shockwave, and V-Wave. It owns shares in Ancora, Applied Therapeutics, Aria, Biostar family Fund, Cagent, Cardiac Success, Orchestra Biomed, Spectrawave, Valfix, and Xenter.
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