Multicenter Study

. 2016 Dec;9(12):e003662.

doi: 10.1161/CIRCHEARTFAILURE.116.003662.

One-Year Outcomes After Transcatheter Insertion of an Interatrial Shunt Device for the Management of Heart Failure With Preserved Ejection Fraction

David M Kaye¹, Gerd Hasenfuß², Petr Neuzil², Martijn C Post², Robert Doughty², Jean-Noël Trochu², Adam Kolodziej², Ralf Westenfeld², Martin Penicka², Mark Rosenberg², Antony Walton², David Muller², Darren Walters², Jorg Hausleiter², Philip Raake², Mark C Petrie², Martin Bergmann², Guillaume Jondeau², Ted Feldman², Dirk J van Veldhuisen², Piotr Ponikowski², Frank E Silvestry², Dan Burkhoff², Christopher Hayward²

Affiliations

¹ Department of Cardiology, Alfred Hospital, Melbourne, Victoria, Australia (D.M.K., A.W.); Georg-August Universität, Gottingen, Germany (G.H.); Na Homolce Hospital, Prague, Czech Republic (P.N.); St Antonius Ziekenhuis, Nieuwegein, The Netherlands (M.C.P.); University of Auckland, New Zealand (R.D.); CHU de Nantes, France (J.-N.T.); Fourth Military Hospital, Wroclaw, Poland (A.K.); Universität Klinikum Dusseldorf, Germany (R.W.); Cardiovascular Center Aalst, Belgium (M.P.); University Medical Center Schleswig-Holstein, Kiel, Germany (M.R.); Department of Cardiology, St Vincent's Hospital, Sydney, New South Wales, Australia (D.M., C.H.); Department of Cardiology, Prince Charles Hospital, Brisbane, Queensland, Australia (D.W.); Klinikum Großhadern, Munich, Germany (J.H.); Internal Medicine, University of Heidelberg, Germany (P.R.); Golden Jubilee Hospital, Glasgow, Great Britain (M.C.P.); Cardiologicum Hamburg, Germany (M.B.); Bichat Hospital, INSERM, Paris, France (G.J.); Northshore University Health System, Evanston, IL (T.F.); University Medical Centre, Groningen, Netherlands (D.J.v.V.); Wroclaw Medical University, Czech Republic (P.P.); Hospital of the University of Pennsylvania, Philadelphia (F.E.S.); and Columbia University, New York, NY (D.B.). david.kaye@bakeridi.edu.au.
² Department of Cardiology, Alfred Hospital, Melbourne, Victoria, Australia (D.M.K., A.W.); Georg-August Universität, Gottingen, Germany (G.H.); Na Homolce Hospital, Prague, Czech Republic (P.N.); St Antonius Ziekenhuis, Nieuwegein, The Netherlands (M.C.P.); University of Auckland, New Zealand (R.D.); CHU de Nantes, France (J.-N.T.); Fourth Military Hospital, Wroclaw, Poland (A.K.); Universität Klinikum Dusseldorf, Germany (R.W.); Cardiovascular Center Aalst, Belgium (M.P.); University Medical Center Schleswig-Holstein, Kiel, Germany (M.R.); Department of Cardiology, St Vincent's Hospital, Sydney, New South Wales, Australia (D.M., C.H.); Department of Cardiology, Prince Charles Hospital, Brisbane, Queensland, Australia (D.W.); Klinikum Großhadern, Munich, Germany (J.H.); Internal Medicine, University of Heidelberg, Germany (P.R.); Golden Jubilee Hospital, Glasgow, Great Britain (M.C.P.); Cardiologicum Hamburg, Germany (M.B.); Bichat Hospital, INSERM, Paris, France (G.J.); Northshore University Health System, Evanston, IL (T.F.); University Medical Centre, Groningen, Netherlands (D.J.v.V.); Wroclaw Medical University, Czech Republic (P.P.); Hospital of the University of Pennsylvania, Philadelphia (F.E.S.); and Columbia University, New York, NY (D.B.).

PMID: 27852653
PMCID: PMC5175994
DOI: 10.1161/CIRCHEARTFAILURE.116.003662

Multicenter Study

One-Year Outcomes After Transcatheter Insertion of an Interatrial Shunt Device for the Management of Heart Failure With Preserved Ejection Fraction

David M Kaye et al. Circ Heart Fail. 2016 Dec.

. 2016 Dec;9(12):e003662.

doi: 10.1161/CIRCHEARTFAILURE.116.003662.

Authors

Affiliations

¹ Department of Cardiology, Alfred Hospital, Melbourne, Victoria, Australia (D.M.K., A.W.); Georg-August Universität, Gottingen, Germany (G.H.); Na Homolce Hospital, Prague, Czech Republic (P.N.); St Antonius Ziekenhuis, Nieuwegein, The Netherlands (M.C.P.); University of Auckland, New Zealand (R.D.); CHU de Nantes, France (J.-N.T.); Fourth Military Hospital, Wroclaw, Poland (A.K.); Universität Klinikum Dusseldorf, Germany (R.W.); Cardiovascular Center Aalst, Belgium (M.P.); University Medical Center Schleswig-Holstein, Kiel, Germany (M.R.); Department of Cardiology, St Vincent's Hospital, Sydney, New South Wales, Australia (D.M., C.H.); Department of Cardiology, Prince Charles Hospital, Brisbane, Queensland, Australia (D.W.); Klinikum Großhadern, Munich, Germany (J.H.); Internal Medicine, University of Heidelberg, Germany (P.R.); Golden Jubilee Hospital, Glasgow, Great Britain (M.C.P.); Cardiologicum Hamburg, Germany (M.B.); Bichat Hospital, INSERM, Paris, France (G.J.); Northshore University Health System, Evanston, IL (T.F.); University Medical Centre, Groningen, Netherlands (D.J.v.V.); Wroclaw Medical University, Czech Republic (P.P.); Hospital of the University of Pennsylvania, Philadelphia (F.E.S.); and Columbia University, New York, NY (D.B.). david.kaye@bakeridi.edu.au.
² Department of Cardiology, Alfred Hospital, Melbourne, Victoria, Australia (D.M.K., A.W.); Georg-August Universität, Gottingen, Germany (G.H.); Na Homolce Hospital, Prague, Czech Republic (P.N.); St Antonius Ziekenhuis, Nieuwegein, The Netherlands (M.C.P.); University of Auckland, New Zealand (R.D.); CHU de Nantes, France (J.-N.T.); Fourth Military Hospital, Wroclaw, Poland (A.K.); Universität Klinikum Dusseldorf, Germany (R.W.); Cardiovascular Center Aalst, Belgium (M.P.); University Medical Center Schleswig-Holstein, Kiel, Germany (M.R.); Department of Cardiology, St Vincent's Hospital, Sydney, New South Wales, Australia (D.M., C.H.); Department of Cardiology, Prince Charles Hospital, Brisbane, Queensland, Australia (D.W.); Klinikum Großhadern, Munich, Germany (J.H.); Internal Medicine, University of Heidelberg, Germany (P.R.); Golden Jubilee Hospital, Glasgow, Great Britain (M.C.P.); Cardiologicum Hamburg, Germany (M.B.); Bichat Hospital, INSERM, Paris, France (G.J.); Northshore University Health System, Evanston, IL (T.F.); University Medical Centre, Groningen, Netherlands (D.J.v.V.); Wroclaw Medical University, Czech Republic (P.P.); Hospital of the University of Pennsylvania, Philadelphia (F.E.S.); and Columbia University, New York, NY (D.B.).

PMID: 27852653
PMCID: PMC5175994
DOI: 10.1161/CIRCHEARTFAILURE.116.003662

Abstract

Background: Heart failure with preserved ejection fraction has a complex pathophysiology and remains a therapeutic challenge. Elevated left atrial pressure, particularly during exercise, is a key contributor to morbidity and mortality. Preliminary analyses have demonstrated that a novel interatrial septal shunt device that allows shunting to reduce the left atrial pressure provides clinical and hemodynamic benefit at 6 months. Given the chronicity of heart failure with preserved ejection fraction, evidence of longer-term benefit is required.

Methods and results: Patients (n=64) with left ventricular ejection fraction ≥40%, New York Heart Association class II-IV, elevated pulmonary capillary wedge pressure (≥15 mm Hg at rest or ≥25 mm Hg during supine bicycle exercise) participated in the open-label study of the interatrial septal shunt device. One year after interatrial septal shunt device implantation, there were sustained improvements in New York Heart Association class (P<0.001), quality of life (Minnesota Living with Heart Failure score, P<0.001), and 6-minute walk distance (P<0.01). Echocardiography showed a small, stable reduction in left ventricular end-diastolic volume index (P<0.001), with a concomitant small stable increase in the right ventricular end-diastolic volume index (P<0.001). Invasive hemodynamic studies performed in a subset of patients demonstrated a sustained reduction in the workload corrected exercise pulmonary capillary wedge pressure (P<0.01). Survival at 1 year was 95%, and there was no evidence of device-related complications.

Conclusions: These results provide evidence of safety and sustained clinical benefit in heart failure with preserved ejection fraction patients 1 year after interatrial septal shunt device implantation. Randomized, blinded studies are underway to confirm these observations.

Clinical trial registration: URL: https://www.clinicaltrials.gov. Unique identifier: NCT01913613.

Keywords: heart failure; hemodynamics; physiology; therapeutics.

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Figures

**Figure 1.**
A, Bar graph represents the effects of interatrial septal shunt device implantation on New York Heart Association (NYHA) class (n=60), (B) Minnesota Living with Heart Failure Score (MLWHF; n=60), and (C) 6-min walk distance (6MWD; n=55). **P<0.01, ***P<0.001 vs baseline. B and C, Data represent mean±SD.

**Figure 2.**
Bar graphs representing (A) left ventricular ejection fraction (LVEF; n=53), (B) right ventricular ejection fraction (RVEF; n=47), (C) left ventricular end-diastolic volume index (LVEDVI; n=53), (D) right ventricular end-diastolic index (RVEDVI; n=48), (E) left atrial volume index (LAVI; n=53), and (F) right atrial volume index (RAVI; n=47). *P<0.05, **P<0.01, ***P<0.001 vs baseline. Data are mean±SD.

**Figure 3.**
Bar graph showing workload indexed peak exertion wedge pressure before and after interatrial shunt device placement (n=16). *P<0.05, **P<0.01 vs baseline. Data are mean±SD. PCWP indicates pulmonary capillary wedge pressure.

See this image and copyright information in PMC

Comment in

Heart failure: Interarterial shunt device for HFpEF.
Huynh K. Huynh K. Nat Rev Cardiol. 2017 Jan;14(1):6. doi: 10.1038/nrcardio.2016.194. Epub 2016 Dec 1. Nat Rev Cardiol. 2017. PMID: 27905475 No abstract available.

References

1. Owan TE, Hodge DO, Herges RM, Jacobsen SJ, Roger VL, Redfield MM. Trends in prevalence and outcome of heart failure with preserved ejection fraction. N Engl J Med. 2006;355:251–259. doi: 10.1056/NEJMoa052256. - PubMed
1. Bhatia RS, Tu JV, Lee DS, Austin PC, Fang J, Haouzi A, Gong Y, Liu PP. Outcome of heart failure with preserved ejection fraction in a population-based study. N Engl J Med. 2006;355:260–269. doi: 10.1056/NEJMoa051530. - PubMed
1. Ponikowski P, Voors AA, Anker SD, Bueno H, Cleland JG, Coats AJ, Falk V, González-Juanatey JR, Harjola VP, Jankowska EA, Jessup M, Linde C, Nihoyannopoulos P, Parissis JT, Pieske B, Riley JP, Rosano GM, Ruilope LM, Ruschitzka F, Rutten FH, van der Meer P Authors/Task Force Members. 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. Eur Heart J. 2016;37:2129–2200. doi: 10.1093/eurheartj/ehw128. - PubMed
1. Reddy YN, Borlaug BA. Heart Failure With Preserved Ejection Fraction. Curr Probl Cardiol. 2016;41:145–188. doi: 10.1016/j.cpcardiol.2015.12.002. - PubMed
1. Shah SJ, Kitzman DW, Borlaug BA, van Heerebeek L, Zile MR, Kass DA, Paulus WJ. Phenotype-specific treatment of heart failure with preserved ejection fraction: a multiorgan roadmap. Circulation. 2016;134:73–90. doi: 10.1161/CIRCULATIONAHA.116.021884. - PMC - PubMed

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One-Year Outcomes After Transcatheter Insertion of an Interatrial Shunt Device for the Management of Heart Failure With Preserved Ejection Fraction

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One-Year Outcomes After Transcatheter Insertion of an Interatrial Shunt Device for the Management of Heart Failure With Preserved Ejection Fraction

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