The impact of atrial flow regulator implantation on hemodynamic parameters in patients with heart failure

Background    Left atrial decompression has emerged a new option to treat patients with heart failure and dyspnea at rest or during exercise. Here we report the impact of atrial flow regulator (AFR) implantation on hemodynamic parameters in patients at our center with heart failure and with reduced (HFrEF) or with preserved left ventricular ejection fraction (HFpEF).
Material and methods    The PRELIEVE trial is designed to assess the safety and efficacy of the AFR in patients with HFrEF or HFpEF. Patients with left ventricular end-diastolic pressure ≥15 mmHg at rest or ≥25 mmHg during exercise and with an ejection fraction ≥15 % were enrolled. Echocardiographic data, 6‑min walking distance, Kansas City Cardiomyopathy Questionnaire, and brain natriuretic peptide levels were assessed pre- and post-AFR implantation and at 3 mos. Invasive hemodynamic assessments were also performed pre- and post-AFR implantation and at 3 mos.
Results    27 (69.2 %) patients with HFrEF and 12 (30.8 %) patients with HFpEF at our center were enrolled in this study. A significant decrease was observed in pulmonary arterial wedge pressure regardless of EF (p=0.007 for HFrEF and p=0.03 for HFpEF). No significant difference of mean pulmonary arterial pressure, right arterial pressure and cardiac output (CO) existed at 3 months compared with pre-implantation baseline values.
Conclusion    AFR implantation led to decrease in left ventricle filling pressure without the deleterious impact on CO and right heart function regardless of ejection fraction.

1. Gheorghiade M, Filippatos G, De Luca L, Burnett J. Congestion in Acute Heart Failure Syndromes: An Essential Target of Evaluation and Treatment. The American Journal of Medicine. 2006;119(12):S3–10. DOI: 10.1016/j.amjmed.2006.09.011

2. Borlaug BA, Nishimura RA, Sorajja P, Lam CSP, Redfield MM. Exercise Hemodynamics Enhance Diagnosis of Early Heart Failure With Preserved Ejection Fraction. Circulation: Heart Failure. 2010;3(5):588–95. DOI: 10.1161/CIRCHEARTFAILURE.109.930701

3. Maeder MT, Thompson BR, Brunner-La Rocca H-P, Kaye DM. Hemodynamic Basis of Exercise Limitation in Patients With Heart Failure and Normal Ejection Fraction. Journal of the American College of Cardiology. 2010;56(11):855–63. DOI: 10.1016/j.jacc.2010.04.040

4. Ponikowski P, Voors AA, Anker SD, Bueno H, Cleland JGF, Coats AJS et al. 2016 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure: The Task Force for the diagnosis and treatment of acute and chronic heart failure of the European Society of Cardiology (ESC) Developed with the special contribution of the Heart Failure Association (HFA) of the ESC. European Journal of Heart Failure. 2016;18(8):891–975. DOI: 10.1002/ejhf.592

5. Bui AL, Horwich TB, Fonarow GC. Epidemiology and risk profile of heart failure. Nature Reviews Cardiology. 2011;8(1):30–41. DOI: 10.1038/nrcardio.2010.165

6. Søndergaard L, Reddy V, Kaye D, Malek F, Walton A, Mates M et al. Transcatheter treatment of heart failure with preserved or mildly reduced ejection fraction using a novel interatrial implant to lower left atrial pressure. European Journal of Heart Failure. 2014;16(7):796–801. DOI: 10.1002/ejhf.111

7. Malek F, Neuzil P, Gustafsson F, Kaye DM, Walton A, Mates M et al. Clinical outcome of transcatheter treatment of heart failure with preserved or mildly reduced ejection fraction using a novel implant. International Journal of Cardiology. 2015;187:227–8. DOI: 10.1016/j.ijcard.2015.03.198

8. Del Trigo M, Bergeron S, Bernier M, Amat-Santos IJ, Puri R, Campelo-Parada F et al. Unidirectional left-to-right interatrial shunting for treatment of patients with heart failure with reduced ejection fraction: a safety and proof-of-principle cohort study. The Lancet. 2016;387(10025):1290–7. DOI: 10.1016/S0140-6736(16)00585-7

9. Paitazoglou C, Özdemir R, Pfister R, Bergmann MW, Bartunek J, Kilic T et al. The AFR-PRELIEVE trial: a prospective, non-randomised, pilot study to assess the Atrial Flow Regulator (AFR) in heart failure patients with either preserved or reduced ejection fraction. EuroIntervention. 2019;15(5):403–10. DOI: 10.4244/EIJ-D-19-00342

10. Erdem A, Sarıtas T, Zeybek C, Yucel IK, Erol N, Demır H et al. Transthoracic echocardiographic guidance during transcatheter closure of atrial septal defects in children and adults. The International Journal of Cardiovascular Imaging. 2013;29(1):53–61. DOI: 10.1007/s10554-011-9933-z

11. Sambhi MP, Zimmerman HA. Pathologic physiology of Lutembacher syndrome. The American Journal of Cardiology. 1958;2(6):681–6. DOI: 10.1016/0002-9149(58)90264-9

12. Hochrein M, Eckardt W. Zur Dynamik Verschiedener Klappenfehler, Insbesondere der Mitralstenose und Aorteninsuffizienz. Klinische Wochenschrift. 1930;9(1):12–4. DOI: 10.1007/BF01740703

13. Little RC. Volume elastic properties of the right and left atrium. The American Journal of Physiology. 1949;158(2):237–40. DOI: 10.1152/ajplegacy.1949.158.2.237

14. Ikenaga H, Hayashi A, Nagaura T, Yamaguchi S, Yoshida J, Rader F et al. Left atrial pressure is associated with iatrogenic atrial septal defect after mitral valve clip. Heart. 2019;105(11):864–72. DOI: 10.1136/heartjnl-2018-313839

15. Lurz P, Unterhuber M, Rommel K-P, Kresoja K-P, Kister T, Besler C et al. Closure of Iatrogenic Atrial Septal Defect After Transcatheter Mitral Valve Repair: The Randomized MITHRAS Trial. Circulation. 2021;143(3):292–4. DOI: 10.1161/CIRCULATIONAHA.120.051989

16. Chigurupati K, Reshmi LJ, Gadhinglajkar S, Venkateshwaran S, Sreedhar R. Pulmonary edema following transcatheter closure of atrial septal defect. Annals of Cardiac Anaesthesia. 2015;18(3):441–4. DOI: 10.4103/0971-9784.159827

17. De Rosa R, Schranz D. Creation of a restrictive atrial left-to-right shunt: a novel treatment for heart failure. Heart Failure Reviews. 2018;23(6):841–7. DOI: 10.1007/s10741-018-9741-9

18. Rodés-Cabau J, Bernier M, Amat-Santos IJ, Ben Gal T, Nombela-Franco L, García Del Blanco B et al. Interatrial Shunting for Heart Failure: Early and Late Results from the First-inHuman Experience With the V-Wave System. JACC. Cardiovascular interventions. 2018;11(22):2300–10. DOI: 10.1016/j.jcin.2018.07.001

19. Guimaraes L, Bergeron S, Bernier M, Rodriguez-Gabella T, del Val D, Pibarot P et al. Initial Experience with the Second-Generation V-Wave Shunt for Treating Patients with Chronic Heart Failure. EuroIntervention. 2020;15:1426–8. DOI: 10.4244/EIJ-D-19-00291

20. Hasenfuß G, Hayward C, Burkhoff D, Silvestry FE, McKenzie S, Gustafsson F et al. A transcatheter intracardiac shunt device for heart failure with preserved ejection fraction (REDUCE LAP-HF): a multicentre, open-label, single-arm, phase 1 trial. The Lancet. 2016;387(10025):1298–304. DOI: 10.1016/S0140-6736(16)00704-2

21. Shah SJ, Feldman T, Ricciardi MJ, Kahwash R, Lilly S, Litwin S et al. One-Year Safety and Clinical Outcomes of a Transcatheter Interatrial Shunt Device for the Treatment of Heart Failure with Preserved Ejection Fraction in the Reduce Elevated Left Atrial Pressure in Patients With Heart Failure (REDUCE LAP-HF I) Trial: A Randomized Clinical Trial. JAMA Cardiology. 2018;3(10):968–77. DOI: 10.1001/jamacardio.2018.2936

22. Kadado AJ, Islam A. Iatrogenic atrial septal defect following the MitraClip procedure: A state‐of‐the‐art review. Catheterization and Cardiovascular Interventions. 2021;97(7):e1043–52. DOI: 10.1002/ccd.29149

23. Feldman T, Mauri L, Kahwash R, Litwin S, Ricciardi MJ, van der Harst P et al. Transcatheter Interatrial Shunt Device for the Treatment of Heart Failure With Preserved Ejection Fraction (REDUCE LAP-HF I [Reduce Elevated Left Atrial Pressure in Patients With Heart Failure]): A Phase 2, Randomized, Sham-Controlled Trial. Circulation. 2018;137(4):364–75. DOI: 10.1161/CIRCULATIONAHA.117.032094

24. Baumgartner H, De Backer J, Babu-Narayan SV, Budts W, Chessa M, Diller G-P et al. 2020 ESC Guidelines for the management of adult congenital heart disease. European Heart Journal. 2021;42(6):563–645. DOI: 10.1093/eurheartj/ehaa554

25. Kaye D, Shah SJ, Borlaug BA, Gustafsson F, Komtebedde J, Kubo S et al. Effects of an interatrial shunt on rest and exercise hemodynamics: results of a computer simulation in heart failure. Journal of Cardiac Failure. 2014;20(3):212–21. DOI: 10.1016/j.cardfail.2014.01.005