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Impact of atrial flow regulator (AFR) implantation on 12-month mortality in heart failure

Insights from a single site in the PRELIEVE study

Auswirkung der Implantation eines Atrial Flow Regulator (AFR) auf die 12-Monats-Sterblichkeit bei Herzinsuffizienz

Erkenntnisse aus einem Zentrum im Rahmen der PRELIEVE-Studie

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Abstract

Background

Implantation of the atrial flow regulator (AFR) to create an interatrial left-to-right shunt has been shown to be safe and feasible to reduce intracardiac filling pressures in patients with heart failure (HF).

Objectives

We aimed to assess the effect of AFR implantation on 12-month mortality and hospitalization rates in patients with reduced (HFrEF) or preserved HF (HFpEF).

Methods

One-year follow-up data from 34 subjects enrolled at a single PRELIEVE center were analyzed. The 12-month predicted mortality was calculated using the Meta-Analysis Global Group in Chronic Heart Failure (MAGGIC) risk score. Patients were divided into two groups, according to their history of hospitalizations for HF.

Results

Study data of 34 patients (HFrEF: 24 [70.6%]; HFpEF: 10 [29.4%]) were assessed. Median follow-up duration was 355 days. In total, 14 (41.2%) patients were hospitalized during the follow-up period and 6 (17.6%) of these patients were hospitalization for HF (HHF). A total of 24 hospitalizations occurred in this period and 8 (33%) hospitalizations were for HHF. The median baseline MAGGIC score was 23 and the median predicted mortality was 13.4/100 patient years. Observed mortality was 3.1/100 patient years. The observed survival (97%) was 10.3% (95% confidence interval 3.6–17.5%, p = 0.004) better than the predicted survival (86.6%).

Conclusion

Our results suggest that AFR implantation has favorable effects on mortality in patients with heart failure, regardless of ejection fraction. Furthermore, compared to baseline, left ventricular filling pressure (assessed by echocardiography) decreased significantly without right side volume overload at the 1‑year follow-up.

Zusammenfassung

Hintergrund

Die Implantation eines Atrial Flow Regulator (AFR), um einen interatrialen Links-Rechts-Shunt zu erzeugen, hat sich als sicher und machbar erwiesen, um den intrakardialen Füllungsdruck bei Patienten mit Herzinsuffizienz zu verringern.

Ziele

Das Ziel war, den Einfluss der AFR-implantation auf die 12-Monats-Sterblichkeit und die Hospitalisierungsrate bei Patienten mit einer Herzinsuffizienz mit reduzierter (HFrEF) oder erhaltener Ejektionsfraktion (HFpEF) festzustellen.

Methoden

Dafür wurden die Nachbeobachtungsdaten von 34 an der PRELIEVE-Studie beteiligten Personen in einem Zentrum über einen Zeitraum von 12 Monaten analysiert. Die Einjahresmortalität wurde mit dem MAGGIC-Risk-Score (Meta-Analysis Global Group in Chronic Heart Failure) berechnet. Die Patienten wurden entsprechend den vorangegangenen Krankenhausaufenthalten wegen Herzinsuffizienz in zwei Gruppen unterteilt.

Ergebnisse

Es wurden die Studiendaten von 34 Patienten (HFrEF: 24 [70,6 %]; HFpEF: 10 [29,4 %]) ausgewertet. Der mittlere Nachbeobachtungszeitraum betrug 355 Tage. Insgesamt kam es bei 14 (41,2 %) Patienten in dem Nachbeobachtungszeitrum zu Klinikeinweisungen, bei 6 (17,6 %) dieser Patienten war Herzinsuffizienz der Grund für die Hospitalisierung. Insgesamt gab es in diesem Zeitraum 24 Klinikaufenthalte, bei 8 (33 %) war der Grund Herzinsuffizienz. Das mittlere baseline-Risiko des MAGGIC-Score lag bei 23 und der Median der prognostizierten Mortalität bei 13,4/100 Patientenjahre. Die beobachtete Mortalität lag bei 3,1/100 Patientenjahre. Das beobachtete Überleben (97 %) war 10,3 % (95 % Konfidenzintervall: 3,6–17,5 %, p = 0,004) besser als das prognostizierte Überleben (86,6 %).

Schlussfolgerung

unsere Ergebnisse legen nahe, dass sich die AFR-implantation unabhängig von der Ejektionsfraktion günstig auf die Sterblichkeit bei Patienten mit Herzinsuffizienz auswirkt. Überdies nahm im Vergleich zur Baseline bei der Nachuntersuchung nach einem Jahr der linksventrikuläre Füllungsdruck (durch Echokardiographie gemessen) deutlich ab, ohne eine rechtsventrikuläre Volumenüberlastung zu verursachen.

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Acknowledgements

We would like to thank to our cathlab workers for their devoted supports.

Funding

The study was supported by Occlutech International AB.

Availability of data and material

The datasets generated during and/or analyzed during the current study are available in the Clinicaltrials.gov repository, https://clinicaltrials.gov/ct2/show/NCT03030274?term=AFR&draw=2&rank=2.

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N/A

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Authors and Affiliations

  1. Cardiology Department, Bezmialem Vakif University, Adnan Menderes bulvari, Fatih/Istanbul, Turkey

    Nijad Bakhshaliyev MD, İlke Çelikkale MD, Asım Enhoş MD, Erdem Karaçöp MD, Mahmut Uluganyan MD & Ramazan Özdemir MD

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  1. Nijad Bakhshaliyev MD
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  2. İlke Çelikkale MD
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  3. Asım Enhoş MD
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  4. Erdem Karaçöp MD
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  5. Mahmut Uluganyan MD
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  6. Ramazan Özdemir MD
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Contributions

NB (designed the analysis, performed the analysis, wrote the paper), İÇ (collected data, contributed data, wrote the paper), EK (designed the study, performed analysis, wrote the paper), AE (designed the study, review, supervision), MU (collected data, review, supervision), RÖ (designed the study, review and editing, supervision).

Corresponding author

Correspondence to Nijad Bakhshaliyev MD.

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Conflict of interest

N. Bakhshaliyev, İ. Çelikkale, A. Enhoş, E. Karaçöp, M. Uluganyan and R. Özdemir declare that they have no competing interests.

Study protocol was approved by local ethical committee. All studies performed were in accordance with the ethical standards indicated in each case. Consent for publication: N/A. Consent to participate: Obtained from all participants.

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Bakhshaliyev, N., Çelikkale, İ., Enhoş, A. et al. Impact of atrial flow regulator (AFR) implantation on 12-month mortality in heart failure. Herz 47, 366–373 (2022). https://doi.org/10.1007/s00059-021-05063-w

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  • DOI: https://doi.org/10.1007/s00059-021-05063-w

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